Document wDVo9yKZpzGaNJyDLBJgyMN53

Tuesday October 16, 1979 PLAINTIFF'S I EXHIBIT KM-383 Part III Environmental * Protection Agency Reproposal of Toxic Substances Control Act (TSCA) Premanufacture Notice (PMN) Forms and Provisions of Rules KMX 01178 59764 Federal Register / Vol. 44. No. 201 / Tuesday. October 16.1979 / Proposed Rules ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 720 [FRL--1314-1; OTS-050002E] Reproposal of Premanufacture Notice Form and Provisions of Rules agency: Environmental Protection Agency (EPA), Office of Toxic Substances. action: Reproposal of Toxic Substances Control Act (TSCA) Premanufacture Notice (PMN) forms and provisions of rules: request for public comment. summary: On January 10,1979. EPA proposed rules and notice forms to govern premanufacture notification for new chemical substances in accordance with section 5(a)(1)(A) of TSCA. In response to numerous comments. EPA is reproposing the following: (1) Briefer notice forms for domestic manufacturers, importers, and exporters that require submitters to provide significantly less detailed information, and (2) certain provisions of the rules concerning confidentiality and supplemental reporting. dates: Written comments must be submitted by November 30,1979. EPA will meet with interested members of the public who wish to discuss and comment on this reproposal from October 16,1979 to November 30,1979. Following the 45-day period, the Agency will hold at least one public meeting to discuss the comments. Persons who want to meet with Agency representatives either during or after the comment period should refer to the section of this notice entitled "Comments and Public Meetings". ADDRESS: All comments should bear the identifying notation OTS-050002E and be addressed to Document Control Officer, Office of Toxic Substances (TS793). EPA. 401 M Street. SW., Washington, D.C. 20460. FOR FURTHER INFORMATION CONTACT: Mr. John B. Ritch, Director, Industry Assistance Office (TS-799), U.S. Environmental Protection Agency, 401 M Street, SW., Washington, D.C. 20460; 600-424-9065 toll free; in Washington. D.C., please call 554-1404. SUPPLEMENTARY INFORMATION: EPA proposed the Premanufacture Notification Requirements and Review Procedures (40 CFR Part 720) on January 10,1979 (44 FR 2242). Section 5(a)(1)(A) of TSCA requires each person who intends to manufacture or import a new 2. Summary of Comments on January 10 chemical substance for a commercial purpose to submit a PMN to EPA at least 90 days before he commences such manufacture or importation. A "new" chemical substance is one that is not included on the TSCA section 8(b) Proposal 3. Revised Approach III. Supplemental Reporting A. January IO Proposal B. Summary of Comments on January io Proposal C. Revisions to Proposed l 720.50 Inventory of Chemical Substances. At D. Revisions to Proposed j 720.51 the end of the notification period, the IV. Costs and Economic Impact Issues person may manufacture or import the substance unless EPA has taken action to ban or otherwise regulate the substance. The requirement to submit PMN'8 took effect on July 1,1979, 30 A. January 10 Proposal B. Summary of Comments on January 10 Proposal C. Revised Analysis V. Comments and Public Meetings IV. Public Record days after EPA first published the TSCA Inventory (44 FR 28558 May 15,1979]. Reproposed Premanufacture Rules Thirty days after the Agency publishes the Revised Inventory (see 44 FR 28558, 28561-64] the premanufacture I. Confidentiality: 40 CFR 720.4O-.45 IL Supplemental Reporting: 40 CFR 720.50 and 720.51 requirements will apply to importers of Revised PMN Forms new chemical substances as a part of I. General Premanufacture Notice Form (Form mixtures. On May 15,1979, EPA for Domestic Manufacturers) published a Statement of Interim Policy Appendix A.--Instructions for Asserting (44 FR 28564) to govern the submittal and review of premanufacture notices prior to promulgation of the final rules and forms. Under the Interim Policy, a PMN must satisfy the requirements of section 5 of TSCA. and Substantiating Claims of Confidentiality ' Appendix B.--Examples of Asserting and Substantiating Claims of Confidentiality Appendix C.--Examples of Process Descriptions II. Importers Form Following is an index to the remainder III. Exporters Form of this preamble and the major elements I. The Premanufacture Notice Form of this reproposal. Preamble L The Premanufacture Notice Form A. January 10 Proposed Form 1. General Approach 2. Summary of Public, Comments B. Revised PMN Form A. January 10 Proposed Form 1. General Approach. The January proposal included the following four separate notice forms that were similar in scope and content but designed for different purposes: (1) Domestic 1. General Approach manufacturers, (2) importers, (3) 2. Optional Part processers, and (4J foreign 3. Forms for Importers and Exporters manufacturers/suppliers. 4. Estimated Costs C. Related Issues 1. Customer Information 2. Form for Low Volume Substances 3. Followup Reporting D. Section-by-Section Review 1. Manufacturer identification 2. Production and Marketing Data 3. Federal Register Notice The form for domestic manufacturers and importers contained mandatory and optional parts. The mandatory parts primarily required information on the identity of the manufacturer or importer, the specific identity of the new chemical substance; and production, use, and human and environmental exposure. 4. Risk Assessment Data Submitters were required to provide the 5. Worker Exposure information requested in the mandatory 6. Environmental Release 7. Byproducts. Co-products. Feedstocks and Intermediates 8. Transport 9. Process Flow Description 10. Consumer and Commercial Exposure ' IL Confidentiality A. Issues Addressed in this Proposal parts to the extent it was "known to or reasonably ascertainable by" them. The optional parts identified information concerning engineering and industrial hygiene safeguards, economics, and the assessment of the sufficiency of data submitted on health and environmental B. Asserting and Substantiating Claims of effects. If a submitter believed that Confidentiality additional information, other than that 1. January 10 Proposal 2. Summary of Comments on (anuary 10 Proposal 3. Revised Approach for Asserting and Substantiating Claims of Confidentiality C. Submittal of Generic Information if Certain Information is Claimed Confidential 1. January 10 Proposal requested in the form, would significantly affect EPA's assessment of risk, he could provide it voluntarily. EP intended for the notice submitter to consider the properties of the new chemical substance, the nature of the business venture, and the costs of completing the optional section(s) whe Federal Register f Vol. 44, No. 201 / Tuesday, October 16, 1979 / Proposed Rules 59765 deciding if it is in his best interest to submit the information contained in the optional part 2. Summary of Comments on January IffProposal. Public interest organizations, other federal agencies, and organized labor generally supported the January 10 proposed forms. Individual companies and trade associations commented that the information requirements of the proposed forms were excessive both in scope and level of detail. Industry commenters primarily were concerned about the specific estimates required in the worker exposure and environmental release sections (e.g., estimates of the concentration of the new chemical substance in effluent streams). The commenters stated that much of these data would not be available at the time a PMN was submitted and that estimates based on pilot-plant -- operations would be unreliable because transfer of production from pilot-plant operation to full-scale operation usually results in a change of almost every equipment parameter. In addition, they stated that the cost of generating such data would impose unreasonable burdens upon submitters. A large number of industry commenters stated that EPA lacks statutory authority to require much of the information in the January 10 proposal. Several industry commenters submitted alternative forms with their comments. Generally, these forms were based upon a narrower interpretation of EPA's statutory authority and data needs than that taken by the Agency. The Chemical Manufacturers Association (CMA--formerly the Manufacturing Chemists Association) submitted a form that would reduce both the scope and the level of detail of the information EPA would receive. For example, questions concerning the transport of the new chemical substance and estimates of workplace concentrations would be optional in the CMA form..Many commenters endorsed the CMA form; some submitted forms with even further data deletions, requiring in some instances little more than the name of the submitter and the chemical identity. Consistent with this narrow interpretation of the premanufacture notification requirements, several industry commenters stated that the level of detail of the proposed forms, indicated that EPA's program objectives went far beyond the intent of Congress. They stated that Congress intended the information requirements of a PMN to be modest in scope and that the time and effort required to submit it should be minimal. They also commented that the Agency's proposed form seemed more appropriate for a registration or certification program (similar to the program for registering pesticides under the Federal Insecticide, Fungicide and Rodenticide Act), instead of a more limited notification program. They stated that EPA's proposed approach would significantly impede innovation in the chemical industry. Finally, some in industry commented that because EPA did not provide specific guidance as to what is meant by the phrase "known to or reasonably ascertainable," it was unclear how much effort EPA expected submitters to expend to gather and format certain types of data. B. Revised PMN Form . Sections 5(d)(1)(A), (B) and (CJ of the Act authorize EPA to require the data specified in both the January 10 proposal and the current reproposal. EPA does not agree with industry's narrow interpretation of the Agency's statutory authority; therefore, the reduced data requirements of the current reproposal do not reflect a determination by EPA that it lacks statutory authority to require additional information. Based on the comments EPA received on this reproposal, the Agency may expand the data requirements when it promulgates the final rules and forms. EPA has two major objectives in revising the January 10 proposed notice form: (1) To obtain adequate information to permit at least a preliminary assessment of the risks associated with the manufacture, processing, distribution in commerce, use. and disposal of new chemical substances; and (2) to achieve this objective at a minimum cost to persons submitting notices. In revising the notice form, EPA considered the minimum information and level of detail necessary for such a preliminary assessment, the likely availability of such information, and the associated costs. Since January EPA has further defined key phases of its process for reviewing PMNs, including information needed for each phase. The Agency faces both time and resource limitations on its ability to review notices. Also, EPA assumes that although some new substances may present risks to health or the environment, most will not require regulatory attention by the Agency. Thus at the beginning of the review process. EPA will review each PMN in an Initial Screen, to identify a small number of chemicals that will be the subject of more detailed assessments and possible regulatory actions. At this time we believe that the information required by the revised form, plus information available to the Agency through quick literature searches, will be adequate to perform this screening function. hi particular, the revised form is designed to provide EPA information to make the following decisions at the end of the screening phase: (1) Select some substances for more detailed evaluation and for which additional exposure or toxicological data are needed; (2) - Identify some that will be subject to requirements for followup reporting concerning their commercial development; (3) Eliminate others from further consideration; and (4) Select a limited number for immediate regulatory attention. When EPA needs additional exposure information, the Agency intends to obtain it from submitters during the notice review period, either voluntarily or by using the authorities of sections 8(a) and 11(c) of TSCA. (Also see Section m. Supplemental Reporting.) For followup reporting, EPA will issue requirements under sections 8 and 5(a)(2). (See Section I-C-3, Related Issues--Followup Reporting.) This ~ approach eliminates the need for companies to submit a considerable amount of information that is not related to EPA's decisionmaking. .............. Finally, EPA believes that this T approach is more cost effective than the one proposed in January. The revised form requests all of the major types of information contained in the January proposal, but at a significantly reduced level of detail. EPA will impose additional reporting burdens only when warranted, based on the contents of PMNs and other information available to the Agency. This will considerably reduce industry's costs of compiling and reporting information on new ' substances, as demonstrated by the revised cost estimates described below. (See Section I-B-4, Estimated Costs.) EPA welcomes comments on whether the objectives discussed above could be accomplished by less burdensome, alternative strategies. Specifically, the Agency encourages representatives of public interest organizations and small businesses to comment. 1. General Approach. The revised forms maintain the mandatory and optional approach of the fonns proposed in January. The notice submitter must provide the information in the mandatory parts of the revised forms to the extent it is known to or reasonably ascertainable by him. This indudes all information in the submitter's possession or control as well as information that he could obtain without unreasonable burden or cost 59766 Federal Register / Vol. 44, No. 201 / Tuesday, October 16, 1979 / Proposed Rules Many in industry have expressed difficulty in determining what information EPA considers to be "reasonably ascertainable". Specifically, they are uncertain about the effort EPA expects them to make in obtaining certain types of information. This is particularly true for information concerning exposure levels, byproducts, and impurities. EPA has considered defining, for each item of information m requested in the form, what the Agency considers to be "reasonably ascertainable". However, what would be a reasonable effort for one company under a certain set of circumstances could be extremely burdensome and costly for the same company under different circumstances (e.g., producing a different chemical substance) or for another company in the same situation. Therefore, a specific definition of "reasonably ascertainable" may result in inequitable treatment of notice submitters. Under the regulations proposed in January, the notice submitter would be responsible for deciding whether and how to obtain the required data, and when information requested in the form is not reasonably ascertainable. In most instances, data generation activities that are so costly as to preclude commercialization of a new substance would not be reasonable. EPA is continuing to evaluate this issue as part of the rulemaking. 2.Optional Part To simplify this reproposal, EPA has not published the optional part of the revised form in this notice. EPA intends to revise the optional part of the form, to include most of the information that the Agency deleted from the mandatory part of the form. Specifically, EPA would make optional some of the information included in Part II, Section B, questions 1-5 of the January proposal. Such information includes: (1) Detailed descriptions and estimates of the magnitude, duration, and frequency of worker exposure to the new chemical substance; (2) explanations of how worker exposure estimates are derived; (3) descriptions of analytical sampling methods and capabilities; (4) sitespecific data, including stack parameters and water effluent and air emission concentrations; (5} explanations of how environmental release estimates are derived; (6) estimates of the efficiency of disposal methods; (7) descriptions of worker exposure during normal disposal operations; (8) descriptions of worker exposure to byproduct materials; (9) estimates of the concentration and flow rate of byproduct materials in water effluent and air emission streams; (10) chemical substance solely for export descriptions of potential hazards to would use the export form. Moreover to transport operators during normal use the form, any processing would have operations and in the event of spills; (11) to be conducted at sites under the . descriptions of safeguards taken to limit control of the manufacturer. If the new risks during transport; (12) detailed chemical substances were transferred to descriptions of the magnitude, duration any other person for processing, the and frequency of consumer exposure to submitter would be required to complete the new chemical substance; and (13) the domestic notice form. descriptions of how consumer exposure If EPA promulgates an exporters' form estimates are derived. The optional the PMN regulations will explicitly state section also would include questions the conditions under which the form . concerning these data as they relate to would be used. EPA specifically invites processing operations. comments on the utility of the proposed As with the January form, at their exporters' form and the proposed discretion, manufacturers may submit conditions under which it should be ' any section(s) of the optional part with used. '' the revised notice form. This optional Section 720.21(c) of the proposed rules information would not be required, and required the importer of.a new chemical a PMN would be complete and satisfy substance to contact the manufacturer the statutory requirements if only the and the person who supplies the mandatory part of the form is substance to the importer and to request completed EPA is considering providing such persons to complete a form for guidance in the instructions manual to foreign manufacturers and suppliers. At the final forms, to aid submitters in this time, EPA is considering whether it deciding whether to submit any of the should retain this provision in the final optional information. EPA would not rules. If the provision is retained the require manufacturers to submit any of Agency will promulgate a separate the optional information; rather, it Foreign Manufacturers/Suppliers Form would identify particular situations that will be modified to be consistent when the Agency would be most with the revised form for domestic interested in obtaining the optional manufacturers. -' ; information. The Agency welcomes comments on the necessity and 4. Estimated Costs ... feasibility of such guidance. Introduction. As part of an effort to EPA received comments that evaluate the economic effects of PMN companies should be able to submit requirements. EPA had an economic optional information in any reasonable contractor prepare unit costs for the format. For example, it was suggested revised PMN form (EPA Contract No. . that notice submitters be permitted to 68-01-4717). The contractor's estimated submit portions of documents which costs include the costs of preparing the they previously developed, such as revised notice form and the attachments standard industrial manuals in lieu of (except for voluntary attachments), but completing the optional industrial do not include the costs of responding to hygiene section. EPA agrees with this supplemental reporting requirements approach to obtaining information on a that may be incurred for some PMN voluntary basis. Although the approach submissions. The report of the undoubtedly will increase EPA's burden contractor's findings, entitled in reviewing PMN's, it could "Estimated Costs of Preparation and significantly reduce the costs of Submission of Reproposed submitting optional information. Premanufacture Notice Form'', is a part 3. Forms for Importers and Exporters. of the record for this rulemaking and is EPA also is proposing separate notice available from EPA's Industry forms for importers and exporters. (The Assistance Office. This section > January 10 proposal did not include a ' summarizes the findings of that study separate form for exporters.) These and presents EPA's interpretation of forms closely parallel the revised form them. '.:] for domestic manufacturers and are consistent with that form in scope and The estimated cost range for the mandatory portion of the revised form, level of detail. Under the rules proposed in January, importers and exporters would not be required to report information concerning commercial activities outside the United States. However, importers and exporters would be required to report information concerning domestic operations. Only submitters who are manufacturing or processing a new not including the costs of asserting and substantiating claims of confidentiality,, is $1,200 to $8,900 per chemical ' substance. EPA believes this cost range^ will apply to most substances submitt1 for premanufacture reviewj howev is conceivable that certain diemic for example very low or high voI substances, will fall below or abov range. Thus, the cost range should. Federal Register / Vol. 44, No. 201 / Tuesday, October 16, 1979 / Proposed Rules 59787 be regarded as reflecting the absolute cost limits for PMN submissions. The costs of asserting and substantiating claims of confidentiality, if claims are made, are estimated to range from $900 to $6,400. EPA does not regard the $900 figure as an absolute lower limit and expects that many companies will be able to comply with the requirements for much less. Thus, including confidentiality costs, the total cost of PMN form submissions are estimated to range from $1,200 to $15,300. The costs of asserting and substantiating'claims of confidentiality are presented separate from the costs of the revised form because to a certain extent they are not affected by the form per se. Rather, they are determined largely by provisions in TSCA itself, the Freedom of Information Act (FOIA), and EPA's general rules regarding the treatment of confidential information (40 CFR Part 2). In addition, the importance of confidentiality to each company's product development strategy will be a major determinant of the costs incurred in asserting and substantiating claims of confidentiality. The contractor did not estimate the proportion of the costs of confidentiality that is attributable to the revised form per se, but EPA believes that it is insignificant, as discussed later in this section. The major cost elements in making a PMN submission, in addition to asserting and substantiating confidentiality claims, appear to be the requirements to retrieve, organize, and submit health and safety data and the requirement to submit a process flow diagram. These requirements and their associated costs are discussed in more detail later in this section. Variables Influencing Costs ofPMN Submissions. The cost ranges for the revised form necessarily are wide, reflecting the extreme variations in the types of companies and chemicals which are subject to PMN requirements. In developing the unit cost estimates, the contractor assumed that the range of notification costs is a function of the following variables: Company-Related Variables Company size Degree of diversification Organizational style Level of technical resources Importance of confidentiality to company's new product development strategy Chemical Substance-Related Variables Apparent toxicity . Anticipated distribution, use. exposure Complexity of production process Complexity of composition of chemical substance Importance of confidentiality for the substance in question. Thus, in the contractor's estimation, The economic contractor's report on the lowest costs of submitting PMN's should apply to substances submitted by small, closely held or private companies with limited technical resources; substances that do not cause significant health or environmental effects; substances for which exposure will be limited; substances that have limited distribution and use, substances for which confidentiality concerns are minimal; and substances that are simple in composition or are synthesized by simple production processes. Conversely, the highest costs of submitting PMN's should apply to substances submitted by large, publicly owned, and diversified companies with extensive technical resources or research arms; substances that may cause significant health or environmental effects; substances for which exposure will be significant: Substances that have extensive distribution and use; substances for which confidentiality concerns are an important factor; and substances that are complex compositions or are synthesized in complex production processes. Breakdown ofPMNForm Costs. Following is a detailed breakdown of the contractor's estimated costs. this reproposal contains more detail on these costs and on the methodology and assumptions used to derive them. Comparison ofJanuary 10 PMN Form and Revised Form. The cost range estimated for the revised PMN form reflects approximately a 50%-60% reduction in costs over the January 10 proposed PMN form. The $1,200 to $8,900 range for the mandatory portion of the revised PMN form compares with the $2,500 to $22,200 range estimated for the mandatory sections of the January 10 form. The difference in costs between the January 10 form and the revised form is due primarily to the reduction in the level of detail of the questions, particularly those dealing with exposure from industrial manufacturing and processing operations. Ecomonic Impact Conclusions-- Caveats. At this time, EPA has not completed an economic impact analysis based on the change in reporting burden introduced by the revised PMN form. This is because the Agency lacks sufficient data on specific new chemicals to determine which types of new ventures would be subject to which levels of reporting costs. Initial findings of the economic contractor from a small, non-random sample of chemical companies indicate that most Total Cost Estimate! tor Completion of Revised substances may be subject to the low PMN Form . end of the cost range, but the Agency is [EPA contractor estimates) ' hesitant to draw conclusions from these data. EPA is preparing an economic Component Cost impact analysis, based on additional Part t General information ........ _______ data on new chemicals, and will publish $275-32,125 this analysis for public comment prior to Part Ik Human exposure and environ mental retease: promulgation of the premanufacture rules and notice forms. This analysis is Section A: Industrial sites controlled bysubmitter_____________________ Section B: Industrial sites controlled by others................... ........................ Section C: Consumer exposure.--... 275-2,100 0- 1,200 0- 800 discussed in more detail in Section TV--Cost and Economic Impact Issues. The cost ranges are based on the assumption that one new Total.___ ______________________ 275- 4.100 substance will be submitted per PMN. EPA realizes that there will be cases Part III: List of Attachments: a. Physical/chemical properties____ 150- 600 b. Health and environmental effects data---- ------- ------------------------------- 300- 1,400 c. Notice attachments 1______________ _____________--__ d Confidentiality attachments 1------- ------------------..---------- where new products or process will be developed that entail multiple new substances, related either in a common process or chemical product. EPA believes that the costs of submitting Total................................... --........ 450- 2.000 PMN's for multiple-substance products or processes will not simply be multiples Part IV: Federal Register Notice.......... 75- 300 of the cost range estimated by the . Clerical costs--all sections........................ 80- 400 contractor, because there will be many Subtotal *............................................ Confidentiality costs--all sections............ 1,155- 8,925 . commonalities among substances 0- 6,400 submitted in this manner. For example, * a PMN for four new chemical Grand total......................................... 1.155-15,325 intermediates to be used in the same 'The costs of listing attachments in pari III--C are negligi ble. - *The costs of providing confidentiality attachments are in cluded in the Irte item entitled "Confidentiality Costs--aM sec tions". Because confidentiality costs were not included in the cost estimates for the form proposed in January, the range of subtotal costs ($1,155-38.925), and not the range of total costs (SI, 155-515,325), should be compared with the Janu process would cost less than four times the cost of submitting a PMN for one intermediate. This is because the information on production process, use, production volume, marketing estimates, and chemical structure probably will be largely the same for all four substances. ary cost estimates. . 59768 Federal Register / Vol. 44, No. 201 / Tuesday, October 16. 1979 / Proposed Rules Contactor's Methodology for Estimating Costs. For the purpose of developing unit cost estimates for the revised PMN farm, the contractor used the same methodology that it used to derive the cost estimates for the January 10 form. That methodology consisted of the following steps: Identification of specific information elements required by the forms; Design of worksheets based on these information elements to obtain estimates of time requirements; Completion of worksheets by . contractor personnel with experience in chemical marketing, chemical and environmental engineering, chemistry, data analysis, and toxicology; Assimilation of information: from worksheets to develop estimated ranges of time required to complete the forms; Multiplication of time estimates by estimated labor rates, to obtain total direct labor costs; . Interviews with selected chemical companies to obtain their time and cost estimates for completing the forms; and Comparison of the chemical companies' estimates for time and costs with the contractor's estimates. Costs ofPMNForms for Importers and Persons Manufacturing Solelyfor Export. EPA did not prepare separate estimates of the costs that would be incurred by importers and persons who manufacture new substances solely for export The Agency will develop estimates as part of its economic impact analysis of the premanufacture rules and notice forms. However, it is possible at this, time to discuss several factors that will influence the level ofdirect costs that may be incurred. The major distinction between the importers' and exporters' forms, and the form for domestic manufacturers, is that importers and exporters would not be required to provide information on human and environmental exposures resulting from manufacturing, processing, distribution in commerce, use. and disposal which occur outside the United States. An importer would not need to submit information on exposure at the foreign facility or facilities where the substance was manufactured or processed. Thus the importer would not incur some and perhaps most of the costs attributed to completing Part II, Section A of the revised form for domestic manufacturers. However, because of the way the contractor prepared the cost estimates for this section of the domestic form, it is not possible to make reliable estimates of the proportion of the costs attributed to this section ($275 to $2,100) that importers would not incur. Similar cost reductions might be experienced by persons who manufacture solely for export. They would be required to submit exposure information only concerning operations within the United States. They would be required to submit information concerning foreign processing sites, under either their own or others' control, or information concerning commercial and consumer exposures, that would occur exclusively outside this country. Therefore exporters would not be subject to the costs ($0 to $800) attributed to completion of Section II-C, Consumer Exposure, of the domestic form. In addition, exporters may not incur some or most of the costs attributed to Section II-A ($275 to $2,100) or Section C-B ($o to $1.200Jof the domestic form, although again it is impossible to give a more definitive range for the likely cost reductions. Overall, the costs of completing the form should be significantly less for persons who manufacture solely for export than for those who manufacture for further processing or use within the United States. ' A second factor that may influence the costs of completing the revised import and export forms is the degree to which information is known to or reasonably ascertainable by the submitter. Thfs factor may influence overall costs in two ways. A submitter that does not possess information called for in a section of the form may state that the information is "not available". This submitter would not be subject to the costs of completing that section of the form. On the other hand, although a person may lack certain information, he may incur costs to obtain it because it is reasonably ascertainable to him. The significance of these factors to importers will depend on the type of importer that submits the PMN. In some cases the importer may be a ' multinational corporation that manufactures the substance outside the United States and processes oruses it in this country. In other cases, the importer may be an intermediary/broker or a domestic processor or user of the substance, who is not involved in manufacturing the substance. The first importer probably would have considerable information available. However, the latter may lack basic information on the substance he imports and would need to contact his foreign supplier for much of the information requested in Parts. I and.LV of the form, including specific chemical identity, production data, physical and chemical properties, and health,and safety studies. Such contacts undoubtedly would add some costs to. completing the PMN. The impact of an importer's lack of information about "downstream" activities involving the chemical substance is less clear. A*broker-type importer may not possess much information about the processing and use ofa substance. This lack of knowledge could reduce the costs of completing the form ifhe enters "hot available"-in response to questions about processing and use. On the other hand. EPA assumes that importers who do not possess thfs basic information will make reasonable efforts to obtain it and may incur some coats in doing so. Taking both of these considerations in account a broker-importer's costs in completing the processing, and use sections of the form may not be distinquishable from costs incurredby a small domestic manufacurer who has limited knowledge about how his customers will process or use a substance. These factors discussed above concerning the availability of information do not provide, a basis for differentiating between exporters and domestic manufacturers. In. general, * exporters will "know"" or find "reasonably ascertainable" the same amount of information concerning chemical identity, manufacturing process, production estimates, physical and chemical properties,, and health and safety studies, as would be known to or reasonably ascertainable by a person who manufactures for domestic consumption. Therefore all other things being equal, there is-no reason to . conclude that an exporter will state that either more or less information is "hot available" or that an'exporter will incur any different costs in obtaining relevant - information from companies. On the basis of this analysis, EPA believes that many persons manufacturing solely for export may incur direct costa that are somewhat less than those incurred by domestic manufacturers. The conclusions are less certain for importers. Some factors ^ would result in lower costs while others. Federal Register / Vol. 44, No. 201 / Tuesday, October 16, 1979 / Proposed Rules 59769 (e.g., contact with foreign suppliers) may lead to higher costs. EPA will further study the costs and economic impacts of the premanufacture requirements on exporters and importers. The Agency requests comments on the factors it should consider in comparing costs likely to be experienced by manufacturers for domestic consumption, manufacturers solely for export and importers. In addition, information developed by particular exporters and importers on the costs they would incur in completing the forms for particular chemical substances, and breakdowns of how those costs are derived, would be very useful to EPA in refining its cost __ estimates. * Significant Cost Components of the Revised PMN Form. Three potentially significant cost components the PMN form merit special attention: (1) The procedures for asserting and substantiating claims of confidentiality: (2) The requirement to provide a process flow description in the PMN form; and (3) The requirement in the form to retrieve, organize, and submit health and safety data. EPA's contractor estimated that the costs of asserting and substantiating claims of confidentiality would range from $0 to $6,400. The costs will vary from substance to substance depending upon the submitter's perceived needs for confidentiality and the amount of resources (legal and technical] he is able and willing to commit to asserting and substantiating claims of confidentiality. In general, EPA believes that larger companies will spend the most of claims of confidentiality and that smaller companies rarely will spend more than $2,000 per PMN. The Agency assumes that both large and small companies may claim the same items confidential because they have the same needs for confidentiality. However, because of their greater legal and technical resources, larger companies will go to greater lengths to identify and substantiate claims of confidentiality. In addition, larger companies probably will encounter greater costs in organizing and coordinating information to substantiate their claims. The contractor did not estimate the incremental costs or burdens of confidentiality introduced by the revised PMN form. However, it would be erroneous to attribute the full amount of the estimated costs to the revised form, because the requirements to assert and substantiate claims of confidentiality in some manner exists regardless of the form that EPA proposes. These requirements are contained in Section 14 of TSCA, the Freedom of Information Act, and EPA's business confidentiality regulations (40 CFR Part 2). Thus, the proportion of the total costs of confidentiality that are attributable to EPA's requirements for asserting and substantiating confidentiality claims may be slight. Even if the required format results in some additional confidentiality costs, the revised approach introduces only a minimal incremental cost or burden over the approach proposed in January. First, the January 10 proposal also required manufacturers to assert claims of confidentiality at the time they submit PMN's, and it required them to substantiate their claims for chemical identity and health and safety studies. These two items appear to be the most burdensome to substantiate in both the January 10 and revised approaches, and probably account for much of the total costs of confidentiality claims. Second, under the January 10 proposal EPA would require manufacturers to substantiate claims for other categories of information in the PMN, such as use and manufacturer's identity, whenever the Agency received FOLA requests for the information. EPA expects to receive FOLA requests for a high percentage of PMN's. If this happens under the January approach, manufacturers would have been required to substantiate many of the items claimed confidential in the PMN's but not substantiated at the time the PMN's were submitted. Finally, the level of effort expended by companies in response to PMN confidentiality provisions will be more a function of company strategy and perceived need for confidentiality than of the precise form and instructions set forth by EPA, and the timing of substantiation. Companies will incur a major proportion of the costs of confidentiality when they develop their PMN strategies on a case-by-case basis. This development of strategy most likely will occur prior to the initial submission of each PMN, and is likely to include the identification of confidential items and linkages and the construction of the rationale for claiming those items. Once a confidentiality strategy has been developed, the incremental cost of preparing specific responses to the substantiation questions, whether done in the initial PMN submission or in later submissions, probably will be slight. In sum. EPA does not believe that a significant incremental burden has been introduced by the revised approach to confidentiality. EPA requests comments on the findings presented here and specifically encourages companies to provide estimates of the time and costs that they actually will spend. The estimated costs for completing the process information portion of the revised PMN form (Part II. Section A-l) are $100 to $600. The costs of reporting process information will be influenced by a number of factors, including the number of steps in the process, the complexity of the process, the number of manufacturing sites, and the final disposition of products and byproducts. Further, the company's degree of sophistication in process engineering and design is largely correlated with the company's size, and will influence the time and costs to complete the process information section. The estimated costs for the retrieval, organization and attachment of health and safety data range from $300 to $1,400, making it a potentially significant coal component. This range reflects differences among companies in the amount of data routinely developed on new chemicals and their ability to retrieve information in the open scientific literature. It also reflects differences among chemicals in the amount of data that are available and must be submitted. For substances with multiple impurities and byproducts that are not on the Inventory and for which data exist, the costs will be the high end of the range. Similarly, PMN's may be more costly for highly toxic chemicals that have more data associated with them. It is important to stress that the revised form has not changed in any way the basic requirement in section 5(d)(1)(B) of TSCA that the manufacturer must submit all health and safety data that are in his possession or control. It also does not specify formatting requirements for the - submittal of test data. The costs of - retrieval, organization, and attachment of health and safety data will be largely unaffected by the PMN form because this statutory requirement exists regardless of the PMN form that submitters must use. A more detailed discussion of the estimated PMN costs, including a section-by-section explanation of the cost estimates, is contained in the separate document entitled "Estimated Costs for Preparation and Submission of Reproposed PMN Form." This is available from EPA's Industry Assistance Office. An appendix to this report includes cost estimates for the PMN form submitted by the Chemical Manufacturers Association during the public comment period on the January proposal. EPA invites comments on all cost esimates presented in the report, as well as on the methodology and i 59770 Federal Register / Vol. 44, No. 201 / Tuesday, October 10, 1979 / Proposed Rules assumptions untilized in developing the costs. Commenters are especially encouraged to provide their own estimates of the time and effort necessary to complete the revised PMN form, using chemicals they manufacture. As mentioned previously, although the data do not exist currently with which to determine with confidence the economic impacts of the revised PMN form, EPA intends to gather additional data and to conduct an impact analysis prior to the promulgation of the premanufacturer rules and notice forms. This analysis will attempt to determine the proportion of new chemicals that will be subject to various levels of PMN costs and will estimate the corresponding effect on the rate of introduction of new chemicals. Also, the analysis will address the costs and impacts of the proposed premanufacturer requirements in their entirety, including the effects of the initial PMN submission requirements, the proposed Section 8(a) supplemental reporting requirements, and various provisions in the proposed rules (e.g,, such as those pertaining to confidentiality- invalid notices, and importers and exporters). This analysis, and EPA's plans far public review and comment is discussed in. more detail in Section IV--Costs and Economic Impacts. C. Related Issues 1. Customer Information. The January proposal would have required the notice submitter to contact persons whom he had reason to believe would purchase the new chemical substance (Part 720, Subpart C. $ 720.20(e)). He would be required to request them to provide information (either to him or directly to EPA) about worker exposure and environmental release associated with their processing operations, and their intended uses of the substance. The January proposal contained a separate customer contact form that requested this information- Submitters also would have been required to include in their PMNs the names: and addresses of those customers contacted EPA received numerous comments from industry concerning this "customer contact" provision. Most questioned EPA's statutory authority to require customer contact They also claimed it would impose excessive administrative burdens, adversely impact innovation, create possible anti-trust violations, and alter the competitive marketplace. Several stated that any customer . contact provision should be limited to persons who had made a firm commitment to purchase the substance. EPA has not decided whether to include the: mandatory customer contact provision in the final rules and is still considering the customer contact form proposed in January. EPA is actively considering the following alternatives to the January 10 proposal for customer contact and invites comment on their practicality. First, to determine the extent of each submitter's knowledge of customer use, the revised form would require the submitter to indicate the number of customers who have made a firm commitment to purchase the substance fora category of use unknown to him (Part I, Section D, question 5). In addition, the submitter would be required to indicate the percent of the estimated'production volume of the new substance that such customers will purchase during the first three years of production. This would give EPA an understanding of how complete the use information is in the premanufacturer notice, and would be less burdensome on the industry than the customer contact provision proposed in January. In combination with other requirements in the revised form- this information would help EPA decide whether to obtain additional use information from the submitter's prospective customers; If EPA determines that it needs additional use information, the Agency can contact the submitter and ask him to voluntarily provide the names and addresses of the relevent customers. EPA also could require the submitter to provide this information under the supplemental reporting provision (see reproposed Part 720- Subpart F- 5 72050). Second, EPA is considering the alternative ofrequiring the submitter to provide a list of the names and addresses of customers who have made a firm commitment to purchase the new chemical substance. This alternative would allow EPA to contact prospective customers directly in cases where use data or other customer information submitted in the PMN is inadequate to assess potential exposures. One advantage to this alternative is that it would eliminate the need for EPA to contact the notice submitter (for customer identities) each time the Agency needs to obtain information from customers. Conversely, it would require all submitters to provide information that the Agency may not use in every case. Further, EPA . recognizes the customers lists often are highly confidential, particularly during research and development EPA is considering each of these altEmatives, or a combination of these alternatives. EPA invites comments on the feasibility of these alternative approaches. It is not necessary to repeat comments previously submitted on the customer contact provisions proposed in January. EPA will consider them when it develops the final rules. _ 2. Form for Low Volume Substances. Based on comments on the January proposal. EPA has considered developing a special PMN form far extremely low volume chemical substances [e.g., substances - manufactured in quantities'of less than one metric ton per year). Such a farm could require even less detailed information than the reproposed form. If necessary, after submittal of the form EPA could obtain additional data on the substance during the notice review period. More often EPA would require follow-up reporting on the substance under section 8(a) or section 5(a)(2) (see discussion below). At this time, EPA is not proposing a form for low volume substances. The revised form would significantly reduce the reporting burden and, therefore, be, appropriate even for very low volume chemical substances. EPA specifically welcomes comments on this issue. Commenters should focus cm the need for a separate form for low volume substances, considering the reduced level of detail required in the revised form. :- . . - 3. Follow-up Reporting.. EPA intends to require follow-up reportingon selected new chemical substances to obtain information not readily available at the time a premanufacture notice is submitted, since manufacforers will be able to report more reliable production- use; and exposure data, oa new substances after they have been commercially developed-At this time, it also will be feasible to perform more extensive health and environmental effects tests. . EPA currently is developing a follow up reporting scheme that would employ a combination of TSCA section 0 reporting rules and section5(a)(2) significant new use rules to track the development of many new chemical substances. Under this scheme, the . Agency would require reporting of certain data over a specific period of . time after premanufacture notification, ' or when specific reporting "triggers" are met (e.g., production of a certain number . of kilograms of the substance). . f- Comments from industry on the January ' proposal suggested such a scheme. Any action the Agency takes concerning the followup of new chemical substances will involve separate rulemakings in r-sjjjp which EPA would propose one or more schemes and allow public comment on them. j Federal Register / VoL 44, No. 201 / Tuesday. October 16, 1979 / Proposed Rules 59771 D. Section-by-Sectian Review Following is a section-by-section discussion of the information requirements that have been deleted from the forms proposed in January and of other modifications contained in the revised form for domestic - manufacturers. EPA invites comments on these changes and the rationales presented below. 1. Manufacturer Identification. Several questions have been deleted from the manufacturer identification section of the January forms. These questions concerned (1) the principal place of business of the submitter, (2) subsidiary companies, and (3) other persons who the submitter authorizes to manufacture the new substance. EPA may need this information if it considers regulating the new substance, however, it is not warranted for all new chemical substances. When necessary, EPA can obtain this information through supplemental reporting during the notice review period. The revised form still would require submitters to include in their production estimates the production volume of others who are authorized to manufacture the new substance. The deletion of these information requirements should not affect the Agency's assessment of the risks presented by new substances. 2. Production and Marketing Data. The January forms required sales volume estimates and an indication of the basis upon which production estimates were reported (i.e., firm order, forecasts, or speculation). Through reporting about sales volume, EPA sought an indication of the distribution of a new substance to other persons. In addition, the "basis of the production estimates" would have demonstrated the uncertainty associated with these estimates. EPA has deleted these requirements from the revised form. The revised form would require production volume estimates to be reported. EPA has deleted estimates of sales volume because it can obtain information about distribution of the substance from other questions in the form (e.g., category of use). The questions concerning the "basis of production estimates" were deleted because EPA will base its exposure assessments for screening purposes on estimates of the maximum production volume. The Agency also will perform market analyses for particular substances of concern and obtain further information from manufacturers on a case-by-case basis. The January 10 proposed form also required estimates of prior production volume and information concerning prior government actions, litigation, or voluntary control of the PMN substance. EPA has deleted these requirements to reduce the reporting burden. The Agency expects to obtain information on prior government actions through a routine search of its own data bases. Therefore, the Agency's risk assessment capabilities will not be diminished significantly. Finallly, EPA has deleted the ranges it had provided for reporting production volume. Rather than impose specific ranges, the revised form would permit a submitter to report production volume estimates in any range he considers appropriate. This approach will provide the Agency with a much clearer estimate of potential production volume and adds no additional reporting burden. When EPA performs exposure assessments, it will focus on the upper end of the range. 3. Federal Register Notice. Under section 5(d)(2) of the Act EPA is required, subject to section 14, to publish a Federal Register notice when a PMN is submitted. This notice must identify the chemical substance, list its uses, and describe certain test data submitted with the PMN. In addition, the Agency is authorized to provide public access to non-confidential data. On January 10, EPA proposed that in addition to the information explicitly listed in section 5(d)(2) of the statute, the Federal Register notice would contain information to further characterize exposure to the substance and its potential effects. This information included estimates of populations exposed and the magnitude and duration of such exposures. Some industry commenters argued that EPA lacked statutory authority to include this additional information in the section 5(d)(2) notice. The revised form proposes a more limited approach to this notice. First, EPA has retained a provision from January that requires the Agency to publish the specific chemical identity unless it is claimed confidential. If it is claimed confidential, the Agency will publish a generic name chosen from three generic names that must be submitted with the PMN. Second, if the manufacturer claims the use confidential, he must report using a generic use scheme that conveys information to interested parties concerning the exposures resulting from the use. Questions proposed in January concerning exposure and release are deleted and replaced with more general indicators of these factors. EPA's generic use scheme is discussed in Section Q below, "Generic Use Information". Third, the revised form would require submitters to abstract only those data that directly concern the new chemical substance, for publication in the Federal Register notice. EPA also would publish a list of all test data submitted with the PMN concerning both the PMN substance and other related chemicals. This approach is consistent with the Agency's intent to reduce reporting burdens and focus reporting requirements on the new chemical substance itself. 4. Risk Assessment Data. The January 10 proposed form contained several risk assessment questions and a table for submitters to check off the types of test data submitted. The risk assessment questions were included in the proposed form to highlight EPA's determination that risk assessment data are part of "health and safety data" and, thus, must be submitted. In some instances, this led to the misconceptions that TSCA requires submitters to perform risk assessments on their new substances. The revised form clarifies this distinction, and deletes the specific questions contained in Part it Section A, of the January 10 form. This change should not result in the submittal of substantially different information than would happen under the January proposal, and simplifies the notice form. EPA included the health effects table in the January proposed form for use by the Agency in organizing data in PMNs. Because this led to the misconception that these data must be developed, EPA has deleted the table from the revised form. Instead, the revised form would require submitters to provide their own list of the data that they have included in the PMN. 5. Worker Exposure. The January 10 proposed form required specific estimates of the magnitude, duration and frequency of worker exposure to the new chemical substance. While these specific estimates would be extremely useful to EPA in assessing worker exposure to new substances, these requirements may be too detailed and burdensome to be imposed on all notice submitters, in cases where the data are available, significant uncertainties also would be inherent in such specific estimates. To mitigate the reporting burden, the revised form requires significantly less detailed estimates and provides ranges for reporting expected workplace concentration levels. Reducing the detail of workplace estimates requires EPA to use other information in the PMN and to make assumptions concerning potential exposure. However, this other 59772 Federal Register / Vol. 44, No. 201 / Tuesday, October 16, 1979 / Proposed Rules information and assumptions should be sufficient for the Agency's initial screening of all new substances. Detailed assessments of priority substances will require more specific information, which will necessitate supplemental reporting by submitters and others on a case-by-case basis. EPA also has eliminated the requirement that the submitter explain how he derived estimates of workplace exposure.. This is in keeping with the Agency's general effort to avoid questions requiring potentially burdensome, narrative responses. If the submitter's estimates do not appear reasonable to EPA, the Agency may contact the submitter to learn how the estimates were derived. However, at this time EPA does not think it is appropriate to require this information in ail PMNs. . Similarly, the revised form would not require specific information about analytical methods that have been developed. The submitter merely must indicate whether a method exists for detecting and quantifying the presence of the new chemical substance in various media. This approach will require increased supplemental reporting in cases where exact knowledge of available techniques is necessary for surveillance and monitoring purposes. 6. Environmental Release. The January 10 proposed form required specific estimates of environmental release data including stack parameters, concentrations, and daily and hourly discharge rates. This information would enable the Agency to perform detailed modeling to assess the environmental impact of new chemical substances. These requirements are not included in the revised form because commenters indicated that they were too burdensome and that in cases where the estimates were reported, significant uncertainties might render Diem useless for purposes of performing risk assessments. Given these comments, EPA does not believe that the requirement should be imposed on all notice submitters. The revised form requires only total release estimates of the new chemical substance. The Agency will make conservative ["reasonable worst case") assumptions concerning release conditions based on standard production practices and other information reported in the PMN. In cases where this approach does not allow an adequate assessment of risk, the Agency intends to require supplemental reporting to obtain more specific estimates if they are known or reasonably ascertainable. Finally, EPA has deleted a general question concerning data on environmental degradation products. The Agency intends to clarify in the ' final rules that these data are considered to be "Health and Safety Data", and they must be submitted under proposed 720.23. 7. Byproducts. Co-products, Feedstocks and Intermediates. The January 10 proposal required the submitter to provide estimates of concentration, flow rates, and the number of persons exposed to byproducts, co-products, feedstocks and intermediates. Because EPA's initial review of PMN's will focus on the new chemical substances themselves, and to minimize the burden on submitters, the Agency has reduced the level of detail concerning environmental release and exposure to such byproduct materials. In the revised form submitters would be required to report the identity of these related substances, and the Agency would obtain further information concerning these substances from other sections of the form (e.g., the process description). This would enable the Agency to identify particular substances of concern while reducing the reporting burden on industry. In some cases, EPA may regulate a substance based on this information. As with other sections of the form where information requirements have been reduced, the Agency may require supplemental reporting by submitters on a case-by case basis. * 8. Transport The January 10 proposed form required submitters to describe the potential risks presented by transport of the new chemical substance. They also were required to discuss intended safeguards to prevent or reduce those risks. EPA has deleted this information from the revised forms because the Agency believes it may be too burdensome to provide and, in most cases, is unavailable. The Agency will make basic assumptions about the potential risks presented by transport of new chemical substances. When Diese assumptions are combined with the information required by the revised form (hazard class designation and mode of transport), and with EPA's evaluation of the toxicity of substances, the Agency will be able to focus its assessment on a smaller and better defined group of new chemical substances. 9. Process Flow Description. The January 10 proposed form required the submitter to provide a detailed schematic flow diagram. This information on the manufacturing and processing operations and the resultant environmental releases is critical for EPA's exposure assessments. This information also supplemented and clarified other data requirements in the January 10 form. However, in an effort to simplify the form and reduce the reporting burden, EPA has deleted several specific requirements from the process description. The revised form does not require description of the type of process equipment the components of each process stream, and process parameters. Rather, it requires a simplified block diagram that will provide a basic understanding of the manufacturing process necessary to identify the potential exposures. (See sample block diagram provided in Appendix C). EPA welcomes comments on the reduced scope of the process flow requirement Commenters are ' encouraged to propose other more appropriate ways to obtain the information required. - ,. 10. Exposure to Consumers and Commercial Users. The January 10 proposed form required the submitter to estimate the magnitude, duration and frequency of consumer exposure to the new chemical substance. TUb information would enable EPA to assess the potential exposure to consumers in the general population who use or . otherwise come in contact with the new chemical substance. The consumer exposure section of the revised form has been modified only slightly from the January 10 proposed form. It requires less specific estimates of the duration and frequency of consumer exposure to the new chemical substance. In addition, the revised form does not require quantitative estimates of the magnitude of consumer exposure unless the submitter already has developed them. EPA will rely upon qualitative data for screening purposes. For detailed assessments, the Agency will seek more specific data from submitters, or will make assumptions about the magnitude of exposure. . Confidentiality A. Issues Addressed in This Proposal In the January 10,1979, proposed premanufaGture notification rules, EPA included several sections describing procedures for asserting claims of confidentiality; and procedures for determining whether PMN information was entitled to confidential treatment , (Part 720, Subpart E. 55 720.40-720.44). EPA intended to use these rules in 'lr* conjunction with the Agency's existing rules concerning confidentiality of business information, 40 CFR Part Zf' Subpart B. ' '''`;: EPA is proposing new procedures for asserting and substantiating n Federal Register / Vol. 44, No. 201 / Tuesday, October 16. 1979 / Proposed Rules 59773 confidentiality claims and for providing precaution against inadvertent release amounts of substantiation required generic descriptions for certain types of by the Agency. reflect the Agency's judgment of the information. If these procedures are Some comments stated that type of information needed to determine adopted, they would replace those information on the form is "private whether the specific information can be proposed in January. However, the property" and should be kept held confidential. Agency is actively considering both confidential automatically. One Third, the proposal provides alternatives. Any comments concerning comment stated that substantiation requirements and new guidelines for I asserting and substantiating claims of should not be required for data providing generic information when confidentiality should consider the protected under section 14(b) of TSCA specific chemical identity, category of earlier proposal, the alternatives (i.e. process and mixtures). use, submitting company's identity and included in this proposal and any other However, representatives of public specific data on physical and chemical schemes that would meet the needs of interest groups favored an approach to properties are claimed confidential. the Agency, industry and the public. confidentiality that would require These new proposals for claiming and This reproposal does not change the submitters to individually substantiate substantiating confidentiality and substantive bases for granting each item claimed confidential when a providing generic information are confidentiality. Nor does this reproposal PMN is submitted. They also suggested discussed in more detail below. discuss the question of confidentiality that EPA abbreviate its procedures for Assertion of Claims. Any item on the for information in a health and safety reviewing claims of confidentiality so form can be claimed confidential. The study, or for specific chemical identity that non-confidential information would Agency has identified five categories as part of health and safety studies. be disclosed more quickly, to the public. into which the majority of However, EPA has received extensive 3. Revised Approach for Asserting confidentiality claims will fall. The five comment on both subjects in response to and Substantiating Claims of categories are-- the January proposal. EPA will address these issues in the rules on premanufacture notification. B. Asserting and Substantiating Claims of Confidentiality 1. January 10 Proposal. Under the January proposal, submitters could assert a claim of confidentiality for any item on the form by checking a box Confidentiality. In this notice, EPA is proposing a revised approach for asserting claims of confidentiality for information submitted as part of a premanufacture notice (on the forms or in attachments to it), and for ' substantiating those claims. In addition, the Agency is modifying and expanding the procedures for providing generic descriptions for certain information A. Manufacturer's (Importer's) Identity B. Specific Chemical Identity . C. Production Volume D. Uses of the New Chemical Substance E. Process Information The Agency recognizes that there may be confidential business information on the form which does not fall into these categories. The submitter may claim this adjacent to the item of information: which is claimed confidential in PMNs. information confidential by using claims would be made on an item-by The proposals are based upon EPA's category F, "other". ., item basis. Submitters could also claim experience with premanufacture notices The instructions indicate which items confidentiality for any information submitted to date, comments received in the form are automatically included contained in attachements to the PMN on the January 10 proposal, and further or "linked" to any of the five categories. form. Submitters were required to reflection upon the various interests of For example, if specific chemical ' submit two copies of those attachments. industry, the public, and the Agency identity is claimed confidential, the CAS One copy was to be complete, with concerning how the Agency determines number is automatically considered " \i confidential items clearly indicated. The whether to release or withhold PMN other copy was to have all information information. chemical identity" and is included in the claim. To assert a claim of claimed as confidential deleted so that it There are three key features to the confidentiality for all the items may be placed in the public file. revised approach. First EPA has automatically linked to a category, the The January proposal required the identified five categories into which submitter is required only to place a submitter to provide substantiation at most confidentiality claims will fall. The check in the box on the form for that the time the PMN was submitted for any submitter, instead of just checking off category. claim of confidentiality asserted with the items claimed confidential, would be To assert a claim of confidentiality for respect to specific chemical identity or required to indicate, by use of a simple an item that is not automatically linked information in a health and safety study. letter code based on these five to a category of claim, the submitter Substantiation for other information categories, into which category the must place the letter representing the could be required at a later date. claim would fall. Submitters would be category in the box next to the item and Substantiation was to consist of required in some cases to provide a brief explain how disclosure of this Itf complete responses to several questions explanation of why they believe a information would reveal the category developed by EPA that would provide particular type of information belongs in of information. To do this, the submitter information to either grant or deny the that category. would answer the corresponding linkage claim of confidentiality 720.40(c)]. Second, rather than substantiating question. The submitter may claim that ]> 2. Summary of Comments on January claims only for chemical identity and any single item is confidential for 1' 10 Proposal. Few industry health and safety data when the PMN is several distinct reasons. For example, if representatives commented on the submitted, submitters would be required an item is claimed confidential because method proposed in the January to provide substantiation for every disclosure would reveal both chemical proposal for asserting claims of category of information claimed identity and process information, the confidentiality on the PMN form. In confidential. For the manufacturer's submitter should place both a "B" and general, industry comments favored the identity category, substantiation would "E" in the box and answer the linkage proposed check-off approach. However, be very simple--the submitter would questions for both categories. two comments suggested that in attest to the truth of a certification . Substantiation of Claims. The revised addition to the check-off, information statement. Other categories of claims premanufacture notification procedure claimed to be confidential should be require more complex substantiation, as employs an incremental approach to stamped "Confidential'' as an extra discussed below. In general, the varying substantiation. For example. 59774 Federal Register / Vol. 44. No. 201 / Tuesday, October 18, 1979 / Proposed Rules manufacturer's identity is substantiated by signing a certification statement similar to the one required to substantiate confidentiality claims on the Inventory reporting form. This is all the substantiation that would be required. For production volume, use data, and process information, in addition to signing the certification statement, the submitter would be required to answer two questions. The first asks whether the submitter's confidentiality concern will be met if the link between the manufacturer's (or inporter's) identity and the item claimed confidential is not disclosed. The second asks whether the submitter's confidentiality concern will be met if the link between the specific . chemical identity and the item claimed confidential is not disclosed. The two questions are designed to lessen the need for multiple confidentiality claims. Finally, to substantiate a claim of confidentiality for chemical identity and for the category of "other" claims, the submitter would respond to a series of questions. Detailed substantiation is required foc^ach item in the category "other" because the information does not fall within one of the five categories identified by EPA. In addition, submitters would be required to explain why disclosure of the specific information would disclosure confidential information if the link between the company and the item is not disclosed and if the link between the chemical identity and the item is not disclosed. In January, EPA proposed in 720.40(c)(1) that a submitter who asserts a claim of confidentiality for chemical identity or health and safety data must substantiate the claim in his PMN. Under proposed 720.40(c)(2), if the company does not provide this substantiation, EPA would notify the company and give it ten days to provide the substantiation before the Agency would place the information in the public record. EPA included this latter provision to ensure that submitters who assert claims, but who unintentionally fail to substantiate them, are given an opportunity to correct this error. The Agency did not intend for proposed 5 720.40(c)(2) to affect the requirement in 720.40(c)(1) that companies must substantiate claims for chemical identity and health and safety data at the time they submit their PMN's. At this time, EPA is not proposing to change section 720.40(c)(2). However, EPA is considering whether it should eliminate this provision in the final rules if the Agency adopts its new scheme for substantiating all claims when PMN's are submitted. A major reason for requiring substantiation when PMN's are submitted is to eliminate delays in giving the public information which is not entitled to confidential treatment. Proposed 720.40(c)(2) is not entirely consistent with this goal because it requires EPA to go back to submitters in all cases where claims are made but substantiation is missing. Further, in most cases EPA will not need to go back to submitters because they will have adequate notice of the Agency's substantiation requirements and should be expected to undertake reasonable steps to ensure that their PMN's are complete. EPA requests comments on whether it should retain proposed S 720.40(c)(2) in the final rules if it promulgates the reproposed scheme for substantiating claims of confidentiality. Health and Safety Studies. The January 10 proposal would require the submitter to respond to a list of questions when substantiating confidentiality claims for information included in health and safety studies. This procedure was proposed because . of the Act's special provisions for release of data from health and safety studies. EPA is proposing an alternative to the January 10 proposal which is consistent with the new approach described above. Information within a health and safety study may be claimed confidential by linking the information claimed to any of the categories proposed by the. Agency. In addition, because of the specific language of section 14(b) of TSCA, a person may claim an item of data from a health and safety study as confidential because it would reveal confidential information on the portions of the substance in a mixture. This is claimed confidential by identifying the item with an "M". Because of the Act's special provisions for release of data from health and safety studies. EPA will deny any claim of confidentiality that does not establish that disclosure of the information claimed would reveal the following confidential information: Specific chemical identity of the chemical substance (only until the commencement of manufacture) Process information Portions of a mixture ' Other information that is unrelated to the effects of the substance on human health and the environment Section 3(6) of the Act defines "health and safety study" to include "studies of occupational exposure." Any exposure information provided on the PMN form derived from a "health and safety study" is subject to the special provisions of section 14(b) of the Act and those described in this section for asserting and substantiating claims of confidentiality for.health and safety studies. In particular, both section A. subsection 3; and section B, subsection 3 of Part of the form would require reporting about worker exposure to the extent such information is known to or reasonably ascertainable by the submitter. * ' EPA specifically invites comment on the extent to which exposure information in PMN's is included in the general definition of "health and safety study". As stated in its January 10 proposal (44 FR 2242, 2258, 2264), EPA interprets the term broadly so that much of the information on exposure included in PMN's could be subject to section 14(b). In addition, the Agency solicits comments on how its proposed scheme for asserting and substantiating claims of confidentiality should be explained and applied to health and safety data contained in the forms themselves. Analysis of the Revised Proposal for Asserting and Substantiating Confidentiality Claims .. . EPA's revision of the procedures for asserting and substantiating . confidentiality claims is based on a variety of administrative and.policy considerations. These include the need to provide non-confidential PMN information to the public, to provide the Agency with information necessary to make judgments under FOIA, and to establish a mechanism for persons to assert claims of confidentiality, with a minimum burden and uncertainty as to the criteria the Agency will use in ; making its determinations. ! EPA's responsibility to provide PMN information to the public is an . . affirmative one, extending beyond any requirement merely to comply with FOIA. Section 5(d)(1) states explicitly that the PMN must be made available for "examination by interested persons," subject to section 14. Further, section 5(d)(2) requires EPA to publish a Federal Register notice which identifies the chemical substance, lists the uses or intended uses, and describes test data. More generally, TSCA includes a variety of provisions whereby citizens can 1 petition the Agency to take particular ' actions with respect to premanufacture notices. EPA interprets such provisions ' as indicating that while the Agency is to be the primary decisionmaker regarding new chemical substances, strong citizen ~ involvement was intended. Effective J] participation is impossible if the . maximum amount of information is not . made available to the public. The proposed scheme serves to ` increase public information in several1 ways. First, by focusing submitters' attention on why items are being claimed confidential and by indicating^ Federal. Register / Vol. 44, No. 201 / Tuesday, October 16, 1979 / Proposed Rules 59775 the type of substantiation EPA must have to grant a confidentiality claim, the scheme will result in defensible rather than unwarranted claims. Second, by requiring a generic description of certain data which is claimed confidential, the scheme should provide the public with important information on the risks of the new substance without revealing confidential business information. In addition to these TSCA-specific responsibilities, EPA has responsibilities under FOLA. Under FOIA, any person may request disclosure of any information submitted in a PMN. When such a request is made. EPA, in accordance with the procedures of 40 CFR Part 2. Subpart B, must review any information claimed confidential to determine whether it is entitled to confidential treatment. If EPA does not disclose information because it determines the information is confidential business information, the requester may bring an action in Federal court to review EPA's decision. In any case, to determine whether information claimed confidential is, in fact, entitled to confidential treatment, EPA requires the submitter of the information to substantiate his claim. Under the January 10 proposal, if substantiation of claims of confidentiality are not included with the PMN, EPA must contact the submitter to request a substantiation of claims. After the person provides this information EPA reviews it and makes a final determination. Under TSCA, EPA provides 30 days notice to the submitter before disclosing the information. It would npt be unusual for the full 90-day PMN review period to expire before EPA could release information in response to an FOIA request--even if the original confidentiality claim was totally without legal merit. EPA's proposed alternative would provide the Agency with all the information it needs to make confidentiality determinations upon receipt of the PMN. Thus, if EPA wished to make a determination of confidentiality (either on its own, or in response to an FOIA request) there , would be a significant savings in time, and an increase in the likelihood that information claimed confidential which is not entitle to such treatment could be made available to the public during the 90-day notice period. Both TSCA and current government policy make it clear that in administration of the Act, unnecessary burdens on industry are to be avoided. EPA believes that the proposed approach provides additional information to the public without substantially increasing the burdens placed on the notice submitter. The earlier proposal would have required submitters to assert a claim of confidentiality at the time of submission and to provide substantiation for two classes of claims--specific chemical identity and health and safety studies. However, if other items were claimed confidential, and EPA received an FOIA request, under its business confidentiality rules, the Agency would contact the submitter and require submission of detailed substantiation for this other data within fifteen business days. EPA is currently using a long letter to explain the information required to substantiate claims of confidentiality in PMN's. Included in this letter is a request that the submitter answer detailed questions to show why confidential treatment should be granted for all information claimed confidential in the PMN. Thus, under the January 10 rules, the burdens of substantiating a claim of confidentiality were divided into two phases--those associated with the filing of the notice itself, and those resulting from the requirement to provide additional substantiation at a later date in response to an EPA request. Under EPA's business confidentiality rules, the submitter must file his substantiation within 15 business days. This deadline is necessary for the Agency to respond to FOIA requests in a timely fashion. Under EPA's January, 1979 proposal this follow-up substantiation procedure would be the rule rather than the exception, because public interest groups have indicated that they intend to submit FOIA requests on all PMNs. While the January 10 proposal and the scheme proposed here impose similar burdens on the notice submitter, the scheme proposed here offers substantially increased certainty about the criteria the Agency will use in making its confidentiality decisions. For each item of information on the form, the submitter would state what type of information an item will reveal, explain why an item reveals that type of information, and substantiate the claim that the information in that category is entitled to confidential treatment. If a submitter makes a reasonable effort to understand the logic of the factors that entitle information to confidential treatment and if, with this understanding, he signs the certification and in good faith provides the appropriate answers to all questions, he would have provided the information which the Agency needs to determine whether to release or withhold PMN information. Of course, EPA's determinations are subject to judicial review. Additional Proposalfor Substantiating Claims of Confidentiality. In addition to the January proposal and this revised scheme, EPA is considering a third approach that combines elements of the first two. The Agency would require substantiation of claims of confidentiality for specific chemical identity, use and test data at the time the PMN is submitted. For other types of information, submitters would have the option of either providing substantiation with their PMN's, or providing substantiation only if EPA specifically requested them to do so, perhaps as a result of an FOLA request This would allow the Agency to review confidentiality claims for the type of information required to be published in the Federal Register notices under section 5(d)(2) of the Act while deferring substantiation of all other information claimed confidential until the receipt of an FOIA request - There are at least two problems with this approach. First although the particular information required to be published by section 5(d)(2) notice is significant for public review, as discussed above, all information in a PMN notice is subject to FOIA requests. Because EPA expects to receive FOIA request for most PMN's, the Agency would be required to request additional substantiation from submitters with the attendant time and resource burdens for both parties. Second, this approach reduces the benefits provided by the revised approach presented in this reproposal. As discussed above, the revised approach provides a scheme which allows the submitter to understand the relationship among his confidentiality claims, and, therefore, not make claims which may be difficult to defend. This third approach, by requiring substantiation of confidentiality claims in two phases, makes it more difficult for the submitter, as well as the Agency, to evaluate the bases for confidentiality claims. The Agency specifically solicits comments on this approach as well as other approaches to providing substantiation of confidentiality claims. C. Submittal of Generic Information if Certain Information is Claimed Confidential 1. January 10 Proposal. In the January proposal, persons claiming the specific chemical identity of a new substance confidential would be required to provide a generic name. This name was to be "only as generic as necessary to 53778 Federal Register / Vol. 44, No. 201 / Tuesday, October 16, 1979 / Proposed Rules protect the confidential identity of the particular chemical substance" and to reveal, to the maximum extent possible, toxicologically significant aspects of the molecular structure. Submitters were to utilize EPA guidelines in constructing generic names ({ 720.41). EPA also proposed that submitters who claimed confidentiality for information on uses of the new chemical substance provide a generic (i.e., less specific) use description and supplement this information with a characterization oflikely exposure to humans or the environment ( 720.42). This procedure would provide the public with information useful in assessing notices and.protect the submitter's confidentiality rights. No other provisions concerning generic information were included in the January 10.proposal. . 2. Summary of Comments on January 10 Proposal. EPA received several comments from industry and trade associations concerning the generic name requirements. The.major concern was that the proposed generic name guidelines would not permit the degree of masking necessary to adequately conceal the specific chemical identity. Commenters also.stated that the requirement to reveal toxicologically significant aspects of the molecular structure is not realistic given the limited understanding of the relationship between structure and biological activity. Some commenters also stated that a submitter of a premanufacture notice who claims specific chemical identity confidential will also need to claim some of the physical and chemical property data confidential to prevent disclosure of the specific chemical identity. 3. Revised Approach. In response to these comments and in an effort to provide the public with meaningful information which can be used in assessing a new chemical substance, the Agency has modified its January 10 proposal. Certain data submitted on the form or attachments would have particular significance in aiding the public in assessing a new chemical substance; however, the Agency recognizes that much of this information may be subject to a claim of confidentiality. Therefore, the Agency has identified four classes of information for which EPA would require the submitter to either provide generic (less specific) information if certain items are claimed confidential, orexplain why this less specific information cannot he provided. The classes of information-are (1) manufacturer's identity, (2) specific chemical identity, (3) use data, and (4) physical and chemical properties data. EPA is proposing the following procedures. If specific chemical identity is claimed confidential and the Agency determines that all of the three generic names proposed by the submitter are mare generic than necessary to protect the confidential identity, the Agency will propose in writing (to the submitter) an alternative generic name. If the EPA proposed name is not acceptable to the submitter, the submitter must explain why disclosure of the generic name would reveal confidential business information and propose another generic name. If the submitter's proposed generic name is acceptable, it will be published in an amendedFederal Register notice under 720.32. If the submitter's proposed generic name is not acceptable, EPA will notify the submitter of its choice and publish.the chosen generic name in an amended Federal Register notice thirty days after this notification. . For manufacturer's identity, use and physical and chemical properties, the procedures for developing acceptable generic descriptions would be modified. If the submitter proposed a generic description that was not developed in accordance with the reporting instructions, he must explain why disclosure of such a generic description . would reveal confidential business information. If the submitter does not provide a generic description or if EPA determines the generic description provided is more generic than necessary to protect confidential business information, the Agency will develop a generic description and notify the submitter. Thirty days after this notification, the generic information will be disclosed to the public. The Agency specifically solicits comments on the guidelines for developing acceptable generic descriptions. Comments should address the procedures for notifying submitters that descriptions reported are more generic than necessary to protect confidential business information, and for requiring the submitter to provide additional generic descriptions if the descriptions they have submitted are not acceptable to the Agency. Chemical Identity. The January 10 proposal required persons claiming the specific chemical.identity of a new chemical substance confidential to provide a generic name. Before submitting a premanufacture notice, the submitter was advised to seek an advance determination by EPA of an appropriate generic name. The advantages of this procedure are that the Agency would not need to publish an amended notice under:{ 720.32(c), uncertainty about EPA's choice of a . generic name would be.resolved prior to submission of the notice, and the public would receive useful information, ifthe prenotice communication.procedure is not used by the submitter, the Agency is proposing the followingmodificatinn to the January 10proposal forproviding generic names. The revised form requires that the manufacturer provide three .different generic names, each masked.in a different manner in order to.give the Agency a choice in determining which name to publish in the Federal Register. (The names not selected'by'EPA would be kept confidential if'their disclosurein conjunction with other information which is disclosed would reveal confidential information.) This approach is being proposed because ofTwo major considerations. First section 5(d)(2) Of TSCA requires the AgencyTo publish in the Federal Register a generic ' description of the new substance within five days of receipt of the notice. This does not allow EPA enough time to resolve problems with respect to the generic name. The Agency believes that the submission of three-names wil] enable it to utilize its own expertised choosing the most toxicologically descriptive name and will increase the likelihood that an acceptable name can 'bepublished in the Federal'Register notice. v"r" - The second consideration is the limited abilityof the Agencytoamenda name once it is published in the Federal Register. Once EPA publishes,a generic name, any subsequent amendment :of that name, taken in conjunction with the one that was originally.published, could reveal confidential information. Consequently, EPA's.ability to provide the public with an amended name would be seriously impaired. . The requirement to submit three names would not apply to individuals who have developed an acceptable generic name through prenotice communication with EPA. ' Generic Use Information. EPA is proposing a modification-of-Its January 10 proposal regardinggeneric use descriptionsfor new chemical substances. The objective .of the revised approach is to provide,information to the public.about use data without compromising the .submitter's .a confidential information. The proposal establishes a framework for submitters to describe generic use for the chemical substance when the specific categories of.use are confidential . , The proposed approach would regufre persons who claim the chemical use confidential to provide a use descrjntinn Federal Register / VoL 44. No. 201 / Tuesday, October 16, 1979 / Proposed Rules 59777 based on several lists of use characteristics provided by the Agency. (See Appendix A.) The categories are-- 1. Degree of Containment 2. Level of Environmental Release 3. Type of Population Exposed * 4. Type of Environmental Release 5. Type of Human Contact 6, Average Frequency of Human Contact Each category includes several characteristics, which describe an aspect of the use of the chemical. The submitter would select the characteristic(s) within each list that describe the use of the chemical. If more than one characteristic on each list describes the use which is claimed confidential, the submitter would select all the characteristics that describe the use. If use has been claimed confidential, the generic characteristics selected will be published in the Federal Register notice in the narrative format proposed in the Appendix. Publication of this generic description of use in the Federal Register notice provides the public with useful information, while avoiding negative effects on innovation and marketing which could result from disclosure of more specific use information. A detailed description of this system is included in Appendix A, Section III. In general, if a submitter adheres to the proposed system of use characterization, a "generic" description of use and exposure should be developed which eliminates the need for any further explanation. If the submitter did not use the scheme developed by the Agency, then the submitter would be required to explain, in an attachment to the premanufacture notice, why use of the scheme would disclose confidential business information. The Agency invites comments on cases in which the lists of characteristics may not provide an accurate description of use from which EPA can develop generic use descriptions. EPA would expect those descriptions to provide information on the level, duration and frequency of exposure as well as characteristics of the population that will be exposed to the new chemical substance. The Agency specifically solicits comments on its generic use classification system. Comments should also address alternative ways to provide sufficient instruction to the submitter for development of generic use descriptions which are only as generic as necessary to protect confidential business information while providing use information to the public as required by Section 5(d)(2) of the Act. Ranges for Physical and Chemical Properties. EPA is proposing a requirement whereby submitters would report physical and chemical properties in ranges if disclosure of the specific value of the property would reveal confidential business information. EPA is proposing ranges for the following. properties: vapor pressure, density, solubility, melting point and boiling point/sublimation point. (See Appendix A, Section III.) Submitters would provide their own ranges for other properties if additional specific physical and chemical properties are claimed , confidential. EPA will also place these ranges in the public file. If the submitter does not use the proposed ranges, he would be required to explain, in an attachment to the form, why use of the ranges would disclose confidential business information and provide alternative generic information. EPA is proposing this approach for several reasons. First the Agency agrees with comments that exact physical and chemical property data, when combined with some generic chemical identity information, may reveal the specific chemical identity of the substance. On the other hand, as indicated in the January 10 proposal, EPA believes that physical and chemical property data are health and safety data and that this data would disclose information on the potential effects of a substance, especially with regard to exposure levels. EPA believes that the use of ranges, as proposed, would address both concerns to a significant extent. EPA intends the ranges to be broad enough to conceal confidential information and narrow enough to provide the public useful information about the new substance. The Agency specifically solicits comments on the concept of using ranges to disclose physical and chemical property data. Comments are also solicited on whether or not the proposed ranges are too broad to provide useful information to the public or if they are too narrow to conceal confidential information. Manufacturer's Identification. EPA also is proposing that the submitter of a PMN who asserts that the fact that his company has submitted a PMN is confidential, must provide a generic description of the company for inclusion in the section 5(d)(2) Federal Register notice. The objective of this requirement is to provide information to the public about the company without disclosing the submitter's confidential identity. The proposal would require persons who claim manufacturer's identity confidential to provide a description based on three categories of . characteristics: (1) General geographic location of the company. (2) size of the company in total annual sales, and (3) type of company by Standard Industrial Classification (SIC) Code. (See Appendix A, Section III.) EPA would publish the characteristics in the ' section 5(d) (2) notice, in a narrative format. In particular, the manufacturer would be required to identify the region of the country (as used by the Bureau of Census in its annual Statistical Abstract of the United States) in which the intended site of manufacture is located, and the total annual sales of the company (in ranges). The manufacturer also must provide the three-digit SIC code for the manufacturing site. . However, if this code will reveal the company's identity when taken together with the information on geographic location and annual sales, the manufacturer should provide a two-digit code and a brief explanation of why a three-digit code is too specific. If the Bubmitter does not know the intended site of manufacture, he should identify the region in which the company's headquarters is located and the primary SIC code for the entire company. EPA invites comments on alternative ways to provide information about the manufacturer or importer to the public without compromising the submitter's legitimate interests in maintaining confidentiality. EPA especially invites comments on whether this will provide useful information to the public about importers of new chemical substances. Comments also should address the characteristics EPA has provided to describe manufacturers and whether the subcategories are only as broad as necessary to protect confidential business information while providing useful information to the public. III. Supplemental Reporting A. January 10 Proposal On January 10,1979, EPA proposed in the Federal Register (44 FR 2242) as part of its Premanufacture Notification Requirements and Review Procedures under Section 5 of TSCA, rules governing supplemental reporting requirements under sections 8(a) and 5 of the Act. The proposed rules provide that EPA may require in writing that certain persons report supplemental information concerning a new chemical substance for which EPA receives a premanufacture notice if it is known to or reasonably ascertainable by them. Small manufacturers (total annual sales less than $1,000,000) would have been exempt from these reporting requirements, except with respect to information which supplements. 69778 Federal Register / Vol. 44, No. 201 / Tuesday, October 16, 1979 / Proposed Rules provides further detail on, or clarifies or:environmental effects of the that included on the PMN form. manufacture, .processing, distribution in The supplemental reporting rules as commerce, use, or disposal of the first proposed would have required substance. The.reporting procedures certain additional informational about were to be identical tothose in $ 720.50. the new chemical substance. First under 720.50(b) EPA could require the manufacturer or importer of a reactant B. Summary of Comments on the January 10proposal of unknown composition to report the EPA received a number of comments identity or composition of the reactant in response to the January 10 to EPA under the following supplemental reporting proposal. circumstances: (1) If a person submitted Although all comments were reviewed a PMN for a substance which was a and considered by the Agency in product of a reaction which includes that reactant and if the submitter has attempted unsuccessfully to obtain the information: and (2) EPA could require a person who-submits a premanufacture notice 720.50(c)), or a person who intends to process a substance for which a premanufacture notice has been submitted ($ 720.50(d)], to provide the following: (1) Information designated "optional" on the notice form; (2) information supplementing, detailing, or clarifying information submitted on the notice form; (3) information concerning the benefits of the substance and the economic consequences of any specified regulation under'TSCA: and, (4) in addition, EPA could require such intended processors to provide information concerning categories of use, amounts processed, manner and menthods of disposal, and any resulting human and environmental exposure that may occur. Such information could be required if it would be relevant to a determination of whether the substance should.be tested under section 4 of the developing the present reproposal, EPA will discuss in this notice only those comments addressing parts of the proposed rule which are being . reproposed. EPA will respond to comments concerning other aspects of the January 10 supplemental reporting proposal when the rule is published in final form. The comments focused on three issues: (1) EPA's authority to require information through letter-writing; (2) the lack of specific criteria indicating when information would be required; and (3) the lack of any procedure for clarifying or objecting to a supplemental reporting requirement. Some commenters questioned EPA's letter-writing authority and thus ' objected to the issuance of a general reporting rule providing for such procedures. The commenters strongly suggested that rulemaking on a case-by case basis would be more consistent with TSCA. The January lO regulations were seen by some commenters as overly broad and vague, giving the EPA or any of its Act controlled under section 5 or section 6, or followed up under sections employees total discretion as to the types of informationwhich could be . 5 or 8. required. To remedy this perceived Paragraph (e) of 720.50 specified the deficiency, commenters suggested that procedures EPA would follow in EPA should promulgate self-executing requiring the submittal of supplemental regulations that outline clear criteria information. EPA would provide a that would enable submitters and written notice to any person subject to a processors to better predict when reporting requirement. The notice was to supplemental information might be include a copy of I 720.50, a detailed required. description of the information to be Commenters also suggested that there submitted, the name and address of the should be procedures for clarifying or person to whom the information was to objecting to a supplemental reporting be submitted, and the date by which requirement. They stated that without submittal was required. This date was such a procedure, administrative review to be no sooner than 15 days after of each request for information would be receipt of the notification. The preamble precluded and regulatees would be stated that only the Assistant deprived of notice and opportunity to be Administrator for Toxic Substances, or heard. one of his Deputy Assistant Administrators, could issue a 5 720.50 C. Revisions to Proposed $ 720.50 supplemental reporting requirement. After an initial review of the An analogous provision to 720.50, comments received on the January 10 proposed 720.51, stated that EPA could proposal, EPA is still convinced that the require any person who has possession reporting approach contained in of a health and safety study to submit 720.50--implementing information that study to EPA, ifEPA found that the requirements by letter rather than by study will assist in evaluating the health case-by-case rulemaking procedures. with notice in the Federal Register is valid andneceBsary.EPA's keyconcem. as-indicated in the January 10 proposal, is time. It would be difficult:to promulgate section 8(a) reporting niles on a case-by-case basis and still receive the needed information within the * section 5 review period. Also, iLiamot clear that full rulemaking procedures are necessary since the supplemental requirement would applytoa single individual who will receive-actual notice of the requirement and be.givenan opportunity to comment The need for supplementalreporting authority is made more acute'bp 'EPA's reproposed PMN form. Exceptin a very limited number of cases, the information contained in a PMN should'be adequate to identify substances and eiqiosures of concern; it. may, however, beinadequate to .determine how or if suchnew . substances should be regulated. Use of supplemental reporting authority to gather additional information lor further evaluation of substances of concern is anintegral part of the Agency's proposal tojeduce the PMN requirements, and If EPA lacks a mechanism Tor oTitaming ' such information an an expeditedbaais, one of EPA's major justifications lor streamlining the PMNform will be " removed. .' While EPA is not proposing,a . modification of the principle,of.imposing reporting requirements under section 8(a) by letter, the Agency-is reproposing this section of the regulations to alleviate some of the.chief concerns expressed in the comments. EPA's major efforthasbeen to develop more`detailed criteria indicating when EPA-may require additional information, and specifying the types of information that the Agency may require if the criteria are met. A second significant change has been to add to the paragraph on "Procedures For Reporting" ^(former 720.50(e)) a mechanism by which the person subject to a proposed reporting requirement can file a request for modification or clarification.of die requirement These major revisions, along with others of a less significant nature, are discuased.in detail below. Subsection (a)(lj of proposed $ 72050 has-been modified to clarify the - applicability of the proposed rule. First, it states that the supplemental reporting requirement may pertain to chemical j substances for which a ;premanufacture notification has been received and ' related substances. Related substances include impurities, .byproducts, : coproducts, degradation products, and unintended reaction products. Thus. EPA will be able to obtain complete information, on exposure-related-to- ^ -- -.o . -, Federal Register / Vol. 44, No. 201 / Tuesday, October 16. 1979 / Proposed Rules 59779 manufacture, processing, distribution in substance which was the product of an exposure to any number of persona or commerce, use, and disposal of a new unknown reactant, the Agency could ecological populations. Thus, if EPA chemical substance. Second, the revised require the manufacturer or the importer lacks data indicating toxicity, the paragraph (a) provides that EPA would to report concerning the composition of Agency would need to meet a more issue supplemental reporting the reactant. EPA is not proposing any rigorous exposure test before requiring requirements under 720,50 only during modification of this provision in this supplemental reporting during the PMN the premanufacture review period notice. However. EPA will, in the future, review period. [including any extensions under section be proposing a rule under section 8(a) to Once one of the findings set out above 5(c) of the Act). This limitation was not require reporting by manufacturers and is made. EPA under the revised contained in the January 10 proposal. importers of unknown reactants. proposal, would require reporting of After the PMN review period EPA would Paragraph (b) may be modified or specific information only if the Agency rely on general section 8(a) reporting deleted when such a rule becomes found that exposure might occur at a rules now being developed. effective. particular stage of a substance's life Paragraph (a)(2) contains the proposed small business definition for the purposes of $ 72&50. The definition is the same as that proposed in January 1979. EPA has received many comments on this proposed definition and is still evaluating them; the Agency is not proposing any modification. Persons may wish to supplement their comments in the context of the revised reporting requirements. EPA is also proposing, in paragraph (a)(2), that the provisions requiring small manufacturers to submit additional information explaining that the PMN be retained. Small business is generally exempt from reporting under section 8(a) of TSCA: it is not exempt from section 5 requirements. Therefore, EPA believes small business can be required under the authority of section 5 to submit information that could have been required in the PMN but was not. The Agency is proposing to modify significantly the scope of the information small buainess could be required to report. The exclusion would now be limited to information which explains or clarifies information the person was required to submit in a premanufacture notice. EPA has deleted the provision that information which "supplements" that submitted in the PMN could also be required because the Agency recognizes that the term "supplements" is broad enough to cover the information the Agency would require under 720.50. The terms "explains" and "clarifies" may be somewhat ambiguous, and EPA solicits comments on how the regulations might more clearly define the boundary between information which could be required under section 5 and other information the Agency will obtain under the authority of section 8(a). Sections 720.50(c) and (d) of the January proposal, which contained supplemental reporting requirements for notice submitters and intended processors, have been replaced by paragraphs (c)--(g) in this proposal. Paragraph (c) of this proposal would require reporting by notice submitters concerning direct human exposure, and paragraph (d) would require reporting by notice submitters concerning environmental release or indirect human exposure. Analogous reporting requirements for persons who intend to process the new substance are contained in paragraphs fe) and (f). Paragraph (g), which would apply to both notice submitters and processors, prescribes information EPA may requires to identify the submitter and its customers, and prescribes information to determine economic significance of the new substance and the impact of possible regulatory actions. The general structure of each paragraph (c) through (f) is as follows. Flrah EPA details the finding the Agency would make before requiring any supplemental reporting; then the rule spells out the types of information EPA may require. Each paragraph sets out the two basic findings which must be made before EPA could require supplemental reporting. The first alternative finding applies to a substance of suspected toxicity. If this determination is made, EPA must also find that the physical and chemical properties of the substance (or chemical fate information, where reporting of environmental release data is concerned) and information on release indicate a potential for human or environmental exposure. As an alternative, EPA may apply a reporting requirement if the Agency determines that it lacks sufficient data cycle. These stages include manufacturing, processing and industrial use. distribution in commerce, disposal, and end use. The last part of each paragraph sets forth the information which may be required for each stage in a substance's life cycle. For example, if under $ 72tX50(c] EPA found that the criteria of paragraphs (c)(2) or (c)(3) were met and that exposure might occur upon end use of a substance; the Agency could require reporting of information on packaging and labeling, use specifications and recommendations, and other similar information. A reporting requirement under paragraph (g) may be issued on the basis of any of the findings under paragraphs (c) through (f>. If such findings are made. EPA may need to identify potential customers. Furthermore, any substance for which such findings are made is a candidate for regulatory action by EPA For most regulatory actions under TSCA EPA will consider available data on economic consequences of the action. In addition, if EPA intends to seek Judicial action under sections 5(e] or 5(f), . specific identifying information for the company may be required. (This Federal Register notice proposes deleting the requirement that submitters provide such information in the PMN.) Finally, in paragraph (h) of & 72050, EPA is proposing a modification of the procedures for imposing a supplemental reporting requirement. As in die January 10 proposal, the requirement will be initiated by a written notice to the person for whom information is required. The regulation specifies that the notice will be signed by the Assistant Administrator or a Deputy Assistant Administrator in the Office of Toxic Substances. This makes clear that these reporting requirements will not be Finally, the revised proposal for paragraph (a)(2) specifically recognizes to determine the potential hazard from the substance. In this situation, EPA issued by lower-level staff members within OTS. that section 8{a)(3)(ii) authorizes EPA to would also have to find that physical Under the proposed approach, the first require small business to report and chemical properties (or chemical notice to the company will be a information in specified circumstances; fate data) indicate a potential for proposed reporting requirement The EPA intends to maintain this authority significant human or environmental contents of this notice will be expanded in 720.50. exposure. In general, exposure could be from those previously proposed. EPA is Proposed paragraph (b) provided that "Bignficant" if it is widespread at any proposing to include a statement of the i( EPA received a PMN for a new level of concentration, or if there is high findings made under this section to 59780 Federal Register / Vol. 44. No. 201 / Tuesday, October 16, 1979 / Proposed Rules require supplemental reporting; in addition, the notice will describe the appeal procedures EPA has established. The proposed appeal procedures, set forth in $ 720.50(h)(2), were developed in response to comments that persons subject to the rule should be given an individual opportunity to comment. The person subject to the requirement would be required to file any formal objections within ten days after his receipt of the reporting notice. This short time period is necessitated by the statutory time limits on PMN review. An objection may include a request for modification or further explanation of the requirement, or a request for an extension of the time period within which to report. In any case, the company would be required to state which specific part of the requirement it is seeking to modify, and to provide a detailed explanation of the grounds for this objection. Provisions for which no objections or requests have been received within the ten-day filing period will become final at the end of the ten day period. EPA would consider all objections or requests regarding the supplemental reporting requirements, and in every case would respond in writing to the objections. EPA could either revoke the proposed requirement, or finally adopt it. The reporting requirement would become final and effective as soon as it was received by the submitter or other person subject to the requirement. Alternatives Considered. In formulating this reproposal, EPA considered two alternative approaches for establishing criteria for imposition of a supplemental reporting requirement The first alternative was to maintain very general criteria similar or identical to those in the proposal of January 10. These criteria were very broad. This alternative would be attractive to EPA because, by setting out more specific criteria, the Agency will inevitably find that in at least some cases information would not be available during the PMN review period. However, EPA recognizes that this approach would not allow industry to anticipate the circumstances under which information would be required. A second alternative considered by EPA was to develop very precise criteria, which would link the presence or absence of specific information on the form to specific categories of information which could be required by EPA. Although this approach would be more responsive to the request for more concrete reporting criteria, EPA has concluded that development of such criteria at this time would be extremely difficult. The state of the art concerning analysis of the risk potential of new chemical substances does not allow for the development of simple equations to determine if a substance presents a risk, and to indicate what if any additional data are necessary to make a responsible evaluation. It would be nearly impossible, for example, to prescribe a specific range of results concerning the activity of analogue substances that could be relied upon, in combination with exposure data, to indicate the Agency's informational needs efficiently and effectively. Intending to avoid both extremes, EPA with this notice is reproposing the rule to clarify-and specify when reporting may be required, without creating a criteria system so complex that it is burdensome and inefficient to administer. D. Revisions to 720.51 EPA is not proposing any revision in the criteria to exercise the Agency's authority to require submission of health and safety studies. The criteria for reporting are simple. First EPA must have some indication that the person possesses a study concerning a particular substance. Second, the study must be such as to assist EPA in evaluating potential health and environmental effects of a substance. Generally, this second finding should not be controversial, because for many new substances (and related substances) there will be little testing available, and each study will have a significant incremental value in understanding potential hazards. EPA has revised 720.51(b) to reflect the new reporting procedures developed for 720.50. While the possible objections to a requirement to provide a particular health and safety study or studies are less complex, and the full procedures of 720.50(h) may not often be necessary to resolve any conflict, this distinction does not justify the maintenance of different reporting procedures under 720.50 and 720.51. Section IV--Cost and Economic Impact Issues A. January 10 Proposal In January 1979 EPA published an economic report entitled "Impact of TSCA Proposed Premanufacturing Notification Requirements" (EPA Contract No. 68-01-4717), which accompanied the proposed premanufacture rules and notice forms. The report was a preliminary attempt to characterize the chemical industry, particularly to estimate the effect that the proposed PMN requirements might have on the development of new chemicals in this country. Although the data and time available to complete the study were limited, the study did provide EPA with the following: (1) A characterization of the chemical industry in terms of products and markets, output growth, foreign trade, employment, and market structure; (2) A characterization of new chemical development practices; (3) An estimate of the range of unit costs possible under the proposed PMN forms; (4) An assessment of the impact of premanufacture notice costs on the rate of introduction of new chemicals; and (5) An estimate of the total industry costs as a result of the proposed PMN forms. EPA acknowledges that the study was limited in scope, because it only addressed the notice form itself. The study did not consider the costs and perceived risks to new product introduction presented by other provisions, such as those dealing with confidentiality, invalid notices, "customer contact", and importers and exporters. Similarly, the study was limited in that it only addressed one measure of impact, the impact on the numbers and types of chemicals introduced for commercial purposes. The conclusions of the study, as interpreted by EPA. were that PMN costs would range from about $2,500 to $22,200 per substance for the mandatory portion of the form, and from about $8,000 to $41,400 for the combined mandatory and optional parts. EPA agreed with the contractor's findings that, in general, the lowest costs of premanufacture notification would apply to substances (1) that are submitted by smaller companies. (2) that are not expected to have significant health/environmental effects or exposure, (3) for which most data are readily available, and (4) for which there is limited distribution and use. EPA similarly agreed with the contractor's findings that the highest costs of premanufacture notification would apply to substances (1) that are submitted by larger companies, (2) that might have significant health/ environmental effects or exposure, (3) for which the existing data would require extensive retrieval and formatting efforts, and (4) for which j there is extensive distribution and use. * Given this range of costs, the report g concluded that one result of PMN requirements could be that the rate of f introduction of chemical substances B could be reduced from 10% (if the $2,5B figure were incurred for all submission) to 90% (if the $41,400 figure were W incurred for all submissions). m Federal Register / Vol. 44, No. 201 / Tuesday, October 16, 1979 / Proposed Rules 59781 The costs and impacts derived in the study may have been overestimated because the study did not adequately take into account the approach that small companies would take to completing the PMN form. Due to the limited technical and legal resources of small companies, and because the answer to many of the questions in the form would be "not available", EPA concluded that the unit costs of notification and, hence, the impacts for many companies would be much lower than these ranges. In addition, EPA believed that the data on which (he analysis was based were insufficient to characterize new chemicals and their development process with an adequate degree of certainty, for purposes of projecting the impacts of the premanufacture requirements. Because inadequate data existed with which to characterize the uses, production processes, and toxicity of the chemicals sampled in the study, no attempt could be made to determine which chemicals in the sample would have been subject to which levels of cost Further, the contractor had to make assumptions concerning the ability of manufacturers to pass foward the costs of premanufacture notification to consumers; the maximum portion of profit that manufacturers might be willing to divert to regulatory costs: and the average length of product life. These assumptions had direct bearing on the outcome of the impact analysis and, m the opinion of EPA, should be subject to closer scrutiny before determining the economic impact of the premanufacture requirements. B. Public Comments During the public comment period following the January 10 proposal, EPA received a number of comments concerning the costs and economic impacts of the proposal. With few exceptions there was general consensus from the industry' that the unit costs estimated by the contractor were accurate and reasonable and that, given those costs,, the conclusions concerning the effect on the rate of introduction of new chemicals were acurate. In light of the contractor's conclusions, industry commenters stated that the burden of the proposed requirements would be onerous, a deterrent to innovation, and a threat to the economic viability of the chemical industry. Although most commenters did not provide much information about their new chemical development practices or about how the PMN requirements would actually affect them, the following common areas of concern were identifiable: (1) Proposed Notice Form--Comments concerning the notice form indicated that the costs of completing the form would be excessive relative to the profits of many new substances. Several companies commented that the scope of the form was too broad and that many companies do not possess the types of expertise identified by the economic contractor as being required to complete the form. (2) Invalid Notice Provisions-- Comments on the invalid notice provisions (proposed & 72034) indicated a concern by many companies that there could be lengthy delays in the notice review process that would erode the commercial attractiveness of certain new ventures (particularly small volume specialty chemicals). This in turn would discourage companies from initiating those types of ventures. However, some companies stated that the possibility for dialogue with EPA in case of ambiguity or error would alleviate some of the uncertainty associated with this provision and, hence, some of the barriers to innovation. (3) Confidentiality Provisions-- Comments concerning the confidentiality provisions indicated that the provisions could be a major deterrent to innovation, depending upon how EPA implemented them. The risks posed by untimely disclosure of chemical identity, company name, or marketing data could create disincentives to develop new chemicals because disclosure would erode a company's competitive advantage in new ventures as-well as its ability to secure patents. '. (4) "Customer Contact" Provisions-- Industry comments on the proposed "customer contact" provisions (proposed 5 720.20(e)) indicated that the procedures for mandatory notification of potential customers would dissuade many potential customers from sampling, testing, and purchasing new substances and would thus create disincentives to the development of new chemicals. (&) Import Provisions--Comments on the provisions for imported substances (proposed 72021) indicated a number of distinct concerns; a. Commenters stated that notification requirements appeared to be less stringent for importers than for domestic manufacturers (due to the omission of workplace exposure questions in. the importers form), and that importers, therefore, would have a cost advantage in bringing new chemical substances to the American market b. Commenters stated that the import provisions would give a competitive advantage to importers or foreign manufactuers by virtue of their ability more freely to test market abroad and screen out commercially unsuccessful substances prim' to submitting PMN*s. c. Commenters stated that the impart provisions would create a non-tariff trade barrier to importation of chemicals due to the requirement for "upstream" commercial contact (proposed 720.21(e)). Because some importers (eg. brokers, intermediaries) do not know very much about the chemicals they import, they would have to rely on foreign manufacturers to provide most of the information to EPA. Becanse these types of importers also typically do not have direct access to their foreign manufacturers, there was concern that there would be difficulties getting the necessary data to EPA In a timely fashion, possibly leading to frequent findings of invalid notice) supplemental reporting requirements, and Section 5fe} actions. (6) Impact on Research and Development (R&DJ Expenditures and - Activities--Several industry . commenters indicated that the . premanufacture requirements would force changes in the R&D expenditure policies of companies. Some companies commented that the increased costs of product development would lower the profitability of basic research, resulting in a cutback in funding for basic ' research and increased emphasis on development and modification of' existing chemicals. ~ (7) Macroeconomic Impacts ofPMN requirements--Several commenters stated that the proposed PMN ' requirements would have far-reachfng effects on the economy as a whole. The importance of innovation in chemical technology to all facets of the American economy, and the reliance on chemical innovation by many other industries for their own competitive advantage in world markets, were said to be a basis for the proposed requirements to have significant effects on gross natural product, the balance of trade, prices, employment, and other macroeconomic indicators. .. . ' (B) Impact on Small Business--Several commenters expressed concern that small businesses would be disadvantageous^ affected by the . proposed requirements. The reasons stated generally were that small companies would not be able to absorb the increases in R&D costs as readfity as larger companies and would be forced to cutback R&D expenditures or to discontinue R&D altogether. It was . stated that this would result in a greater concentration of R&D activities and sales among the larger companies.. 59782 Federal Register / Vol. 44, No, 201 / Tuesday, October 10, 1979 / Proposed Rules C. EPA `s Response to Comments--The adversely effect most manufacturers, Revised Analysis due to the reduced costs of the revised EPA currently is conducting a more in depth study of the proposed premanufacture requirements to respond to the issues raised in the public comment period and to determine with a greater degree of confidence the nature of the results costs and economic impacts. The main purpose of this analysis is to account for the costs and PMN form. However. EPA is aware that even minimal notifiction requirements and time delays may impose special burdens on, and threaten the existence ' of, certain enterprises. Through its data gathering effort. EPA intends to characterize those companies and chemicals that may be adversely affected. impacts of the initial reporting program D. Public Review and Comment in its entirety. EPA will attempt to access the costs and economic implications of the following rules provisions, in addition to the costs and impacts of the notice form itself: This new analysis will focus on the economic costs and impacts of major provisions in the proposed premanufacture rules and forms, and will be based upon an expanded data Confidentiality base. Therefore, before the Agency Invalid Notice promulgates the rules and notice forms, Imports and Exports "Customer Contact" Supplemental Reporting Notice of Continuing Review Extension of Notice Period ' Exemptions for Small Quantities for Research ' and Development Exemptions for Test Marketing Although these assessments are likely to be qualitative EPA believes they will help answer the questions of which, if any, types of companies or ventures will be adversely affected by the rulemaking and how they would be affected. A second purpose of the revised analysis is to attempt to extend the previous analysis by examining more closely the secondary impacts of the premanufacture requirements. The proposed economic analysis examined the impact of the requirements on the rate of introduction of new chemicals. To the extent possible, this revised analysis will assess the effects that changes in the numbers and types of chemicals will have on policies for R&D allocation and expenditure and on industry sales, growth, profitability, and structure. Due to the complexity of the it will publish for public comment a report that includes the new data plus the cost and impact analyses. Notice of the availability of this report will be published in the Federal Register. During the public comment period EPA will solicit input concerning these data and analyses, including the assumptions and methodologies used and conclusions reached. . In general, EPA will not ask the public to provide comments on the technical, legal, and policy aspects of the proposed rules and notice forms--those comments must have been submitted during the public comment period accompanying the January proposal and this current reproposal. However, comments on the economics report may address policy and other non-economic aspects of the rulemaking insofar as decisions on the latter should be influenced by the economic findings and conclusions. EPA will carefully review and use the report and comments received on it in making decisions concerning the contents of the final rules and notice forms. V. Comments and Public Meetings chemical industry, it is not likely that EPA invites comments on all issues this analysis will yield quantitative raised in this notice. Comments on the conclusions. However, it may give some revised notice forms should focus on indication of the direction and types of EPA's general approach, the Agency's change that might occur if EPA need for the information, the availability promulgates the proposed requirements. of requested information to notice The revised analysis will use a submitters, and the burden of obtaining methodolgy similar to that used in the the information and completing the previous economic analysis, but will forms. Do not resubmit comments on the benefit from an improved data base. January 10 proposed rules and forms. Data will be collected on chemicals They will continue to be a part of the recently introduced by as many as 30 official record of this rulemaking. When companies. This should provide EPA promulgates the final rules and information from which to determine the forms, the comments on the January types of chemicals and companies that proposal, as well as the comments on may be affected adversely by the this notice, will be evaluated. premanufacture requirements, and why During the 45-day comment period, they would be so affected. beginning on the publication date of this At this time EPA believes that the notice, EPA personnel will be available premanufacture requirements will not to meet with interested persons from individual companies, trade associations, organized labor, and public interest organizations to discuss the revised notice form and other issues raised in this notice. EPA will provide the facilities and make other necessary arrangements for such meetings. The Agency will prepare transcripts or summaries of the meetings for inclusion in the official public record. The meetings will be open to all members of the public, but active participation will be limited to those persons who request the meetings and EPA participants. Persons should call EPA's Industry Assistance Office at the number listed below for more information (i.e. dates, times, places, participants, topics). Most meetings will be held in Washington, D.C. However, EPA is very interested in obtaining input directly from small companies, local labor officials, and regional public interest organizations. For this reason, the Agency will hold a limited number of meetings outside of Washington where there is a demonstrated interest in and need for such meetings. For example,, EPA officials will agree to meet with a number of small companies at a central location if it is clear that the Agency cannot otherwise receive input from such persons. Persons who wish to meet with EPA representatives should contact the Industry Assistance Office at 800-424 9065; in Washington, D.C. please call 554-1404. This office will arrange times and places for the meetings and, as noted above, will provide such information to the public. . After the public comment period closes, EPA will evaluate the comments received and will hold at least one general public meeting to discuss the comments with interested persons (particularly those who submitted them); the meeting is scheduled as follows: Date: Dec. 12. 1979 Time: 9:00-t:00 Location: Health Education and Welfare Auditorium, 4th Sr Independence Ave. . SW,, Washington, D.C. During the comment period, if EPA determines that it should hold more than one of these general meetings, the Agency will announce them in the Federal Register. In general, any such meetings will be organized around a series of key topics, and will include a panel of EPA officials in dialogue with persons who submitted written comments. The Agency will prepare transcripts of such meetings for inclusion in the public record. Active participation will be limited in these meetings to persons who submit written Federal Register / Vol. 44, No. 201 / Tuesday, October 16, 1979 / Proposed Rules 59783 comments during the 45-day comment period. The Agency does not intend to reopen the comment period for submittal of written comments following these meetings. EPA welcomes suggestions concerning these meetings--(number, formats, and so forth). Address specific comments on this issue to: Director, Industry Assistance Office, Environmental Protection Agency, 401M Street, SW,, Wash. DC20460 VL Public Record EPA has established a public record for this rulemaking (docket number OTS . 050002) that is available for inspection in the OTS Reading Room from 9:00 a.m. to 5:00 p.m., on working days (Room 447E, 401 M Street, S.W., Washington. D.C. 20460). This record includes all of the information considered by the Agency in developing this proposal. The Agency will supplement the record with additional information as it is received. The record includes all of the categories of information listed in the January 10, 1979, Notice of Proposed Rulemaking (44 FR 2263). In particular, the record has been supplemented for the purposes of this reproposal with the following documents: . (1) USEPA--OTS. "Reproposal of Premanufacture Notice Forms and Provisions of Rules: Notice of Proposed Rulemaking." ' (2) USEPA--OTS. (Impact ofTSCA Proposed Premanufacturing Notification Requirements; contract No. 68-01-4717.) (3) Working drafts of the proposed Premanufacture Notice forms dated June 28.1979, July 23,1979, and August 7, 1979. (4) EPA documents distributed at the meetings (and transcripts) of the Administrator's Toxic Substances Advisory Committee (ATSAC), August 14.1979, and September 25,1979. (5) EPA materials on the planned reproposal of the premanufacture notice forms distributed at the Embassy Officials Briefing, September 11,1979. The docket of the record that details its specific contents to date is available in the OTS Reading Room. EPA welcomes comments on any additional material that should be part of the record to date. EPA will identify the complete rulemaking record on or before the date of promulgation of these requirements, as prescribed by TSCA section 19(a)(3). Note.--Under Executive Order 12044, Improving Government Regulations, EPA must determine whether a proposed regulation is "significant" and therefore subject to the requirements of the order. On May 29.1979. EPA published a report on how it will implement the order (44 FR 30988). Consistent with the order and EPA's report the Agency has reviewed the proposed Premanufacture Notification Requirements and Review Procedures (44 FR 2242), January 10,1979, and the forms and rules that are reproposed in this Federal Register notice. EPA has determined that they are "major significant" regulations, as that term is defined in the Agency.'s report (44 FR 30989 90). EPA will issue them in accordance with the requirements of the report concerning internal Agency development and review, public participation, economic analysis, and consideration of other regulatory impacts and alternatives. In particular, see Section I.B.4 above for a discussion of the economic costs of this reproposal and Section IV for a description of other economic analyses that EPA has under way. ' (Secs. 5.8, and 14 of the Toxic Substances Control Act (15 U.S.C. 1604, 2607, and 2613.)) Dated: October 1,1979. Douglas M. Costle, Administrator. 40 CFR 720.40, 720.41, 720.42 and 720.43 are reproposed to read as follows: Section 720.44 is redesignated as S 720.45, and a new 720.44 is added. $ 720.40 General provisions. **** (c)(1) At the time a person submits the information to EPA, he must substantiate all claims of confidentiality. The person must provide substantiation in the manner specified in the reporting instructions. ***** S 720.41 Specific chemical Identity. (i)(A) Submit the specific chemical identity of the substance; and either (B) Report the generaic name which was accepted by EPA in the prenotice consultation under paragraph (a)(2) of this section or (C) Provide three generaic names, each masking the chemical identity in a different manner, and each only as generic as necessary to protect the confidential identity of the particular chemical substance. These names - should reveal to the maximum extent possible toxicologically significant aspects of the molecular structure. Before proposing generic names to meet these criteria, the submitter should consult the guidelines for Creating Proposed Generic Names, published as Appendix II to these rules. The submitter shall explain why a more specific name would reveal confidential business information. (4) * * * (i) If a submitter asserts such a claim, and if he complies with the procedures specified in paragraph (a)(3) of this section, EPA will publish in the Federal Register notice under S 720.32 either the generic name agreed upon by EPA or one of the generic names proposed by the submitter. ***** ,- (iv)(A) If at any time EPA determines that the generic names proposed by the submitter are more generic than necessary to protect the confidential identity, the Agency will propose in writing, for review by the submitter, an alternative generic name that will reveal to the maximum extent possible toxicologically significant aspects of the molecular structure. (B) If the EPA proposed generic name is acceptable to the submitter, EPA will publish the generic name in an amended Federal Register notice under $ 720.32. (C) If the EPA proposed generic name is not acceptable to the submitter, the submitter must explain in detail why disclosure of the generic name would reveal confidential business information and propose another generic name which is only as generic as necessary to protect this confidential information. If EPA does not receive a response from the submitter within 30 days after the person receives this notice, the Agency will publish its chosen generic name in an amended Federal Register notice under 720.32 without further notice. If the submitter does provide the information requested, EPA will review the response. If the submitter's proposed generic name is acceptable, EPA will publish the generic name in an amended Federal Register notice under $ 720.32. If the submitter's proposed generic name is not acceptable, EPA will notify the submitter of its choice of a generic name. Thirty days after this notification, EPA will publish the chosen generic name in an amended Federal Register notice under $ 720.32. ***** .. (b) * * * ` (6) * * * (ii) If EPA determines that the generic name proposed by the submitter is more generic than necessary to protect the confidential identity, die Agency,will propose in writing for review by the submitter an alternative genericname that will reveal to the maximum extent possible toxicologically significant aspects of the molecular structure. (iii) If the EPA proposed generic name is acceptable to the submitter, EPA will place the generic name in an appendix to the inventory. (iv) If the EPA proposed generic name is not acceptable to the submitter, the submitter must explain in detail why disclosure of that generic name would reveal confidential business information and propose another generic name 59784 Federal Register / Vol. 44, No. 201 / Tuesday, October 16, 1979 / Proposed Rules which is only as generic as necessary to protect the confidential identity. If EPA does not receive a response from the submitter within 30 days after he receives this notice, the Agency will place its chosen generic name in an appendix to the inventory. If the submitter does provide the information requested, EPA will review the response. If the submitter's proposed generic name is acceptable, EPA will publish the generic name in an appendix to the inventory. If the submitter's proposed generic name is not acceptable, EPA will notify the submitter of its choice of a generic name. Thirty days after this notification, EPA will place the chosen generic name in an appendix to the inventory. 720.42 Uses and Intended uses of a new chemical substance. (2) Provide, in non-confidential form, a description of the uses that is only as generic as necessary to protect the confidential business information. Before proposing a generic description of the uses to meet these criteria, the submitter should consult EPA's reporting instructions. The generic use description will be included in the Federal Register notice under 720.32. **** (4) Provide a detailed written substantiation of the claim, as specified in the reporting instructions. ***** (d) (1) If the submitter reports a generic use description other than in accordance with the reporting instructions, he must explain in an attachment to the form why disclosure of a generic use description developed in accordance with the reporting instructions would reveal confidential business information. (2) If the submitter does not provide a generic use description, or if EPA determines that the use description provided is more generic than necessary to protect the confidential uses, the Agency will develop a generic use description and notify the submitter. Thirty days after this notification, EPA will publish its chosen generic use description in an amended Federal Register notice under 720.32. $ 720.43 Data from health and safety studies. ***** (e) Ranges for physical and chemical properties. (1) If a submitter has claimed specific chemical properties of the substance confidential, he must report the specific data to EPA and also provide the data for these properties in ranges that are only as generic as necessary to protect the confidential data. These ranges will be placed in the public docket of the premanufacture notice. Before proposing the ranges, the, submitter should consult EPA's ' reporting instructions. (2) The submitter must provide a detailed written substantiation of the claim, as specified in the reporting instructions. (3) If the submitter does not provide this data in the ranges specified by EPA, he must explain in an attachment to the form why disclosure of the data in the specified ranges would reveal confidential business information. (4) If the submitter does not provide ranges for the chemical properties or if EPA determines that the ranges provided are more generic than necessary to protect the confidential data, EPA will assign a range to the data and notify the submitter. Thirty days after this notification, EPA will place the ranges for the data in the public docket 720.44 Manufacturer's identity. (a) If the submitter claims his identity confidential, he must provide a description of the company which is only as generic as necessary to protect the confidential identity. This generic description will be included in the Federal Register notice under 720.32. Before preparing the description, the submitter should consult EPA's reporting instructions. (b) The submitter must provide substantiation of the claim, as specified in the reporting instructions. ,, (c) (1) If the submitter does not follow the reporting instructions for developing a generic manufacturer identity, he must explain in an attachment to the form why disclosure of the generic identity developed in accordance with the reporting instructions would reveal confidential business information. (2) If the submitter does not submit a generic description for manufacturer's identity, or if EPA determines that the description provided is more generic than necessary to protect the confidential identity, the Agency will develop a generic description of the manufacturer's identity and notify the submitter. Thirty days after this notification, EPA will publish the chosen generic manufacturer identity description in an amended Federal Register notice under 720.32. 720.45 Public files. [Redesignated from 720.44.1 ***** 2. 40 CFR 720.50 and 720.51 are reported to read as follows: 5 720.50 Reporting Requirements under section 8(a) and section 5 of the Act (a) General (1) EPA may use the procedures established in paragraph (h) of this section to require persons to report supplemental information during the premanufacture review period. EPA may request information with respect to the manufacture, import, processing, distribution in commerce, use, or disposal of a new chemical substance or related substances for which the Agency receives a premanufacture notice. Related substances include impurities, by-products, coproducts, degradation products, and unintended reaction products. Except as provided in ' paragraph (a)(2) of this section, paragraphs (b), (c), (d), (e), (f), and (g) of this section prescribe the persons who may be subject to these reporting requirements. Information must be submitted if it is known to or reasonbly ascertainable by the submitter or processor. (2) No person whose total annual sales are less than $1,000,000, based upon the person's latest complete fiscal year, shall be subject to a reporting requirement under this section, except for information which explains or clarifies any infomration which the person was required to submit in his premanufacture notice, or information with respect to a substance for which section B(a)(3](ii) of the Act is applicable. In the case of a company which is owned or controlled by another company, total annual sales shall be based on the total annual sales of the owned or controlled company, the parent company, and all companies owned or controlled by the parent company taken together. (b) * * * . (c) Notice submitters'requirement to report information concerning potential risk resulting from direct human exposure.--(1) General IfEPA makes the findings in paragraphs (c)(2) or (c)(3) of this section, and if EPA finds that there may be exposure in the manufacture, processing, distribution in commerce, use, or disposal stages of a chemical substance's life cycle, the Agency may require the submitter of a premanufacture notice to report any of the information specified in paragraph (c)(4) of this section, pertaining to that stage of a substance's life cycle. (2) Finding with respect to substances of suspected toxicity. A finding under this paragraph (c)(2) may be made if all of the following criteria are met with respect to a new chemical substance or a related substance: (i) Information on toxicity submitted with the premanufacture notice or otherwise obtained by EPA indicates the Federal Register / Vol. 44. No. 201 / Tuesday, October 16. 1979 / Proposed Rules 59785 substance may present a significant hazard to humans. The following will be considered: Results of in vitro tests, results of in vivo tests, data an analogues, epidemiological data, and other similar data; (ii) Information on physical/chemical properties indicates a potential for release resulting in human exposure. Properties to be considered include: ' Physical state, vapor pressure, viscosity, particle size distribution, surface tension, solubility, vapor emission rate, and other similar data; and (iii) Information on release submitted in the notice form and any other information obtained by EPA indicates a potential for release resulting in human exposure. (3) Finding with respect to substances of unknown toxicity. A finding under this paragraph (c)(3) may be made if all the following criteria are met: (i) Sufficient data on toxicity have not been submitted~with the premanufacture notice nor have other data been obtained by EPA (including data on analogues) that are sufficient to determine whether the substance may be harmful to humans; (ii) Physical/chemical properties, including those listed in paragraph (c)(2)(ii) of this section, indicate a potential for release resulting in significant human exposure; and (iii) Information on release submitted with the premanufacture notice or any other information obtained by EPA indicates a potential for release resulting in significant human exposure. (4) Information which may be required. EPA may require die following information with respect to the stage of the substance's life cycle for which appropriate findings are made: (i) With respect to the manufacture, processing, or industrial use of a substance, EPA may require information concerning: an explanation of any information presented in the form, equipment specifications, engineering safeguards, operating procedures, industrial hygiene practices, maintenance, cleaning, and preparation procedures, process chemistry, use, and other similar information. (ii) With respect to distribution in commerce, EPA may require the following types of information about the substance, and mixtures and articles containing the substance: Packaging and labeling information, potential for and magnitude of a spill, transport safeguards and handling procedures, and other similar information. (iii) With respect to disposal, EPA may require the following types of information about the substance, and mixtures and articles containing the substance: Waste handling procedures, identity of disposal site, information on method of disposal, and other similar information. (iv) With respect to end use, EPA may require the following types of information about the substance, and . mixtures and articles containing the substance: Formulation or construction of the product, packaging and labeling information, use specifications and recommendations, and other similar information. (d) Notice submitters' requirement to report information concerning potential risk to human health or the environment resulting from environmental release.-- (1) General. If EPA makes the findings in paragraphs (d)(2) or (d)(3) of this section, and if EPA finds that there may be environmental release in the manufacture, processing, distribution in commerce, use, or disposal stages of a chemical substance's life cycle, the Agency may require the submitter of a premanufacture notice to report any of the information specified in paragraph (d)(4) of this section pertaining to that stage of a substance's life cycle. (2) Finding with respect to substances ofsuspected toxicity. A finding under this paragraph (d)(2) may be made if all of the following criteria are met with respect to a new chemical substance or a related substance: (i) Information on toxicity, including data listed in paragraph (c)(2)(i) of this section, submitted with the premanufacture notice or otherwise obtained by EPA, indicates that the substance or mixtures or articles containing the substance may present a significant hazard to human health or the environment; (ii) Information on chemical fate submitted with the premanufacture notice or other information obtained by EPA, including information on potential for environmental transport potential for or nature of transformation in the environment, and potential for bioaccumulation indicates that human or environmental exposure might occur; and (iii) Information on release submitted with the premanufacture notice and any other information obtained by EPA indicates a potential for release resulting in human or environmental exposure. (3) Finding with respect to substances of unknown toxicity. A finding under this paragraph (d)(3) may be made if all the following criteria are met: (i) Sufficient data on toxicity have not been submitted with the premanufacture notice nor have other data been obtained by EPA (including data on analogues) which are sufficient to determine whether the substance may be harmful to humans or the environment; (ii) information on chemical fate submitted with the premanufacture notice and other information obtained by EPA, including data on properties listed in paragraph (d)(2](ii) of this section, indicates that significant human or environmental exposure might occur, and (iii) Information on release submitted with the premanufacture notice and other information obtained by EPA indicates a potential for significant release resulting in human or environmental exposure. (4) Information which may be < required. EPA may require the following information with respect to the stage of the substance's life cycle for which appropriate findings are made: (1) With respect to the manufacture, processing, or industrial use of the substance, EPA may require information concerning: pollution control equipment, existing treatment of the substance, specific aspects of the manufacturing or processing operation, uses of the substance, and other similar - information. ' (ii) With respect to distribution in ' commerce, EPA may require the types of information concerning the substance, and mixtures and articles containing the substance, that are listed in paragraph (c)(4)(ii) of this section. ... .. (iii) With respect to disposal. EPA may require the types of information concerning the substance, and mixtures and articles containing the substance, that are listed in paragraph (c)(4)(iii) of this section. (iv) With respect to end use, EPA may require the types of information concerning the substance, and mixtures and articles containing the substance, that are listed in paragraph (c)(4)(iv) of this section. (e) Processors' requirement to report information concerning potential risk resulting from direct human exposure.-- (1) General. If EPA makes the findings set forth in paragraphs (c)(2) or (c)(3) of this section, and if EPA finds that there may be exposure in the processing, distribution in commerce, use, or disposal stages of a chemical .- substance's life cycle, the Agency may require any person who intends to process a substance for which a premanufacture notice was submitted to report the information specified in paragraph (e)(2) of this section, pertaining to that stage of a substance's life cycle. (2) Information which may be required. EPA may require submittal of the types of information listed in 59786 Federal Register / Vol. 44. No. 201 / Tuesday, October 16, 1979 / Proposed Rules paragraph (c)(4) of this section, with (4) Information concerning the (ii) EPA will consider the objections respect to the stage of the substance's benefits of the substance for various filed, and the Assistant Administrator or life cycle for which appropriate findings uses resulting from either the Deputy Assistant Administrator for have been made. EPA will not require manufacture or the processing of the Toxic Substances will either revoke the information concerning the substance, and the availability of proposed reporting requirement or manufacturing or import of the chemical substitutes for those uses; and promulgate a final requirement. EPA will substance under this paragraph. (5) Information concerning the notify the person who would be subject (f) Processors' requirement to report reasonably ascertainable economic ' to the reporting requirement by letter information concerning potential hazard consequences of any specified control (certified mail, return receipt requested), to health or the environment resulting from environmental release.-- (1) measure under the Act, including impact of the Agency's response to the on the national economy, small objection. The reporting rule will be General. If EPA makes the findings in paragraphs (d)(2) or (d)(3) of this section, and if EPA finds that there may be exposure in the processing, distribution in commerce, use, or disposal stages of a chemical substance's life cycle, the Agency may require any person who intends to process a substance for which a premanufacture notice was submitted to business, technological innovation, the environment, and public health. (h) Procedures for imposing a reporting requirement--{1) Written notification from EPA. If EPA makes the findings required by paragraphs (b>--(g) of this section, EPA will propose a supplemental reporting requirement EPA will notify in writing any person who would be subject to a proposed final and effective upon receipt by the person subject to the reporting rule. 9 72051 Requirements (or Submittal of Health and Safety Studies under section 8(d) of the Act (a) * * * (b) Procedures. (1) EPA will notify in writing any person who would be subject to a proposed reporting report the information specified in paragraph (f)(2) of this section reporting requirement under this section. requirement under this section. The The proposed requirement will be proposed requirement will be signed by pertaining to that stage of a substance's signed by the Assistant Administrator, the Assistant Administrator, or a Deputy life cycle. or a Deputy Assistant Administrator, for Assistant Administrator, lor Toxic (2) Information which may be Toxic Substances. The notification will Substances. The notification will be sent required. EPA may require submittal of be sent by certified mail, with return by certified mail, with return receipt the types of information listed in receipt requested. The .written requested. The written notification will paragraph (d)(4) of this section, with notification will include: indude; respect to the stage of the substance's (i) A copy of this 720.50; (1) A copy of this $ 72051; life cycle for which appropriate findings (ii) A statement of the findings made (ii) A statement of the findings made have been made. EPA will not require by EPA under this section with respect by EPA under paragraph (a) of this information concerning the to the Agency's need for the specified section; manufacturing or import of the chemical information; . (iii) A description of die requested substance under this paragraph. (iii) A detailed description of the study; (g) Person's requirements to submit information which would be required, (iv) The name, address, and telephone other types of information, including with a citation to the paragraph of this number of the person to whom the information concerning the benefits of the substance and the economic section under which the information would be required; information would be submitted: (v) The date by which the information consequences of any specified (iv) The name, address, and telephone would be submitted, which shall be no regulation. If the finding in paragraphs number of the person to whom the sooner than 15 days after the 10-day (c)(2), (c)(3), (d)(2) or (d)(3) of this information would be submitted; period for filing objections under section is made, EPA may require the (v) The date by which the information paragraph (b)(2) of this section has following information from submitters of would be submitted, which shall be no ended; and, premanufacture notices or persons sooner than 15 days after the 10-day (vi) Information on procedures under intending to process the new chemical period for filing objections under paragraph (b)(2) of this section for filing substance, as appropriate: paragraph (h)(2) of this section has objections to the proposed reporting (1) Information concerning the identity ended; and, requirement. of the submitter of the premanufacture (vi) Information on procedures under (2) Submitter's orprocessor's notice, including information on place of paragraph (h)(2) of this section for filing objections or requests for modification. incorporation and principal place of objections to the proposed reporting (i) Within 10 days after a person business; requirement. receives the notice of a proposed (2) Information concerning other (2) Submitter's orprocessor's reporting requirement, he may file companies which are involved with the objections, (i) Within 10 days after a written objections, requesting substance, including subsidiaries submitter or processor receives the modification or explanation of the associated in commercialization notice of a proposed reporting requirement or a change in the reporting activities, or other persons who may requirement he may file written schedule. Any such objections must manufacture the substance in the U.S., objections, requesting modification or specify that part of the proposed or import the substance into the U.S. by explanation of the requirement or a requirement which the person seeks to virtue of an existing or planned business change in the reporting schedule. Any modify and the basis for the objection. arrangement. such objections must specify that part of Any provisions of the reporting (3) Information concerning the identity the proposed requirement which the requirement concerning which no of any persons who have either submitter or processor seeks to modify objections are received within the 10- contracted to purchase, submitted a and the basis for the objection. Any day filing period will become final at the purchase order or made any other firm provisions of the reporting requirement expiration of the 10-day period. commitment to purchase the new concerning which no objections are (ii) EPA will consider the objections chemical substance or related received within the 10-day. filing period filed, and the Assistant Administrator or substances for processing, distribution will become final at the expiration of the Deputy Assistant Administrator for in commerce, industrial or end use; 10-day period. Toxic Substances will either revoke the Federal Register / Vol. 44. No. 201 / Tuesday, October 16. 1979 / Proposed Rules proposed reporting requirement or promulgate a final requirement EPA will notify the person who would be subject to the reporting requirement by letter (certified mail, return receipt requested), of the Agency's response to the - objection. The reporting rule will be final and effective upon receipt by the person subject to the reporting rule. BILUNG CODE 6560-01-M ' 59787 59788 Federal Register / Vol. 44, No. 201 / Tuesday, October 16.1979 / Proposed Rules PROPOSED SEPA United States Environmental Protection Agency PREMANUFACTURE NOTICE DOMESTIC MANUFACTURERS FORM Whtn compl.l.d sand this form to: Document Control OHIcor Ottlco ot Toilc Stibstancoi, TJ-791 U.S.E.P.A. 401 M Strut. S.W. Wathington, O.C. 204SO EPA USE ONLY Date ot receipt GENERAL INFORMATION The Premanufacture Notice (orm for domestic manufacturers is divided into the following parts: Part I - General Information Part II - Human Exposure and Environmental Release Part III - List of Attachments Part IV - Federal Register Notice Part V - Optional Oata The optional part (part VI is not included in this package. All data requested in the mandatory parts (parts I, II, III, and IV) must be reported to the extent they are known to or reasonably ascertainable by the submitter. This means that the submitter is expected to answer all Questions to the best of his/her ability, Including making reasonable estimates in cases where complete factual information is not available. If the submitter is unable to make a reasonable estimate (l.e., the data is not known and is not reasonably ascertainable), he'she should enter "NA" (not available). In part I, the submitter is required to report the specific chemical identity of the new substance, regardless of whether the informa tion is claimed as confidential. In accordance with proposed 720.20(f), the submitter may authorize another person to report the specific chemical identity in his/her behalf. The notice will not be valid until the specific chemical identity is received by EPA. If the space on the form is not sufficient to adequately answer a question, the submitter may attach additional sheets. Identify any continuation by part, section, subsection, and item. ASSERTING AND SUBSTANTIATING CLAIMS OF CONFIDENTIALITY Read Appendix A. Instructions for Asserting and Substantiating Claims of Confidentiality, for information on how to claim and substantiate confidential business information included in this form or in attachments to the form. Claims of confidentiality must be made in accordance with sections I and II of these instruc tions. In addition, substantiation of all claims of confidentiality must be made in accordance with section IV of these instructions. If you claim any item in any attachment to this form confidential, see SPECIAL INSTRUCTIONS for attachments. Appendix A, Section II. Appendix B "Examples," provides additional guidance for asserting and substantiating claims of confidentiality. In accordance with sections I and II of the confidentiality instruc tions, claims of confidentiality must be made by using the follow ing six categories: A. MANUFACTURER S IDENTITY A claim of confidentiality for Category A, Manufacturer's identity, automatically includes items 1, 2, and 3 in parti, section A. - B. SPECIFIC CHEMICAL IDENTITY A claim of confidentiality for category B, Specific Chemical Identity, automatically includes items 1, 2, and 3 in part I, section B. C. PRODUCTION VOLUME A claim of confidentiality for category C, Production Volume automatically includes item I in part I, section D. These items do not need to be individually claimed. D. USE DATA `^ A claim of confidentiality for category 0, Use Data, automati cally Includes item 2 in part I, section D. These items do not need to be individually claimed. E. PROCESS INFORMATION A claim of confidentiality for category E, Process Information, automatically includes items in part II, section A, subsection 2. These items do not need to be individually claimed. F. OTHER INFORMATION No items on the form are automatically included in this category. Thus all claims for this category must specify category F. GENERAL CERTIFICATION I hereby certify to the best of my knowledge and belief, that: a. The company named in section A, item 1, intends to manufac ture for a commercial purpose the chemical substance for which this notice is submitted, other than in small quantities for research and development, and that the substance is not excluded from premanufacture notification (40 CFR 720.13); b. All information entered on this Premanufacture Notice form is complete and truthful as of the date of submittal; and c. I am submitting with this form all test data in my possession or control concerning effects of the substance on health or the environment and a description of any other data known to or reasonably ascertainable by me, in accordance with 40 CFR 720.23. I also agree to permit access to, and the copying of records by a duly authorized representative of the EPA Administrator in accord ance with the Toxic Substances Control Act and any regulations issued thereunder, to document any information reported in this form. Signature of authorized official Date CONFIDENTIALITY CERTIFICATION I hereby certify to the truth and accuracy of the following four statements concerning all information which is claimed confidential. a. My company has taken measures to protect the confidentiality of the information, and it will continue to take these measures; b. The information is not, and has not been, reasonably obtain able by other persons (other than governmental bodies) by using legitimate means (other than discovery based on a showing of special need in a judicial or quasi-judicial proceeding) with out the company's consent; e. The information is not publicly available elsewhere; and d. Disclosure of the information claimed confidential would cause substantial harm to my company's competitive position. Signature of authorized official Date Federal Register / VoL 44. No. 201 / Tuesday, October 16,1979 / Proposed Rules 59789 Part 1 - GENERAL INFORMATION Section A - MANUFACTURER IDENTIFICATION If you claim Manufacturer'! identity confidential, mark (X) the bon at the tight. The answers to items 1, 2, and 3 will be included in this claim. ................... 1 If you claim the answers to-rtems 4 or 5 confidential, place the tettefls) A-F in the box which indicate! the basis of your claim and answer the linkage questions in appendix A, section II, tor categories A--E. 1 I Person Filing Notice Name of authorized official Organization . Title Mailing address (Number and street) City, State, ZIP code * ,,_ 2. Technical Contact Name Mailing address (Number and street) City, State, ZIP code 1. Parent Company Name Mailing address (Number and street) City, State, ZIP code Title . } Area cod* j Number Telephone i i ' - Confiden tial code ggg Vjt US 8 4. Enter the intended date of commencement of manufacture for commercial purposes. If the: intended date of commencement of manufacture is more than 3years after the date of this notice, submit evidence of intent to manufacture in accordance with 40 CFR 720.20(h). . | [ Varit this box it you attach evidence. _l 5- If you have had a Prenotice Communication (PC) concerning this notice l and EPA assigned a PC number to this notice, enter PC Number----------------- * Month -r-rf Year Mask (X) if none i--i 1 1 CONTINUE WITH SECTION B ON PAGE 3 4 Pas* 2 59790 Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules fc Section B - CHEMICAL IDENTITY If you claim Chemical Identity confidential, mark (X) the box at the right.----------------------------------------p. 1 The answers to items 1, 2, and 3 will be included in this claim. If you claim Chemical Identity confidential, is this claim limited to the period prior to manufacture? _ 1 Q] Yes __ a 1 1 No If you claim the answer to item 4 confidential, place the lettertsl A-F in the box which indicates the basis of your claim and answer the linkage questions in appendix A, section II, for categories A-E. 1 Complete either 1, 2, or 3 as appropriate. Complete 4. 1. Class 1 Chemical Substance (other than polymers) . CAS Registry No. (if known) b. Specific chemical name . c. Molecular formula d. Synonyms ( Trademarks Confiden tial code f. Structural diagram 2 Class 2 Chemical Substance 1 1 Mark this box it you attach a continuation sheet. * CAS Registry No. (if known) b. Specific chemical name -' * S'K ;;v . 1 '; m. : *- c. Synonyms d. Trademarks a. List the immediate precursor substanceis) and reactants with their respective CAS Registry Numbers) and describe the nature of the reaction. Also provide a partial or incomplete chemical structure diagram (where appropriate). Indicate the range of composition. . Mark this box it you attach a continuation sheet. Page 3 Fedora] Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules 59791 3. Polymers . (1) Provide the specific chemical names and the CAS Registry Number of those monomers and other reactants used in the manufacture of the polymer. (2) Mark (X) the identity column if you wish monomers used at two percent (by weight) or less to be listed as part of the polymer description on the inventory, (3) Provide the intended range of composition of the polymer in terms of monomer percent (by weight). If your notice is for any copolymer of the listed monomers, enter "any" under Range of Composition. 14) For each monomer, indicate the maximum amount (weight percent) that may be present as a residual in the polymer as distributed in commerce. Monomers and CAS Registry No. (1) Identity Mark (X) (2) Range of composition (3) Maximum amount (weight percent) (4) Confiden tial code (5) 6. Indicate the minimum average molecular weight or the minimum degree of polymerization of the polymeric compositions to which this notice applies. [Jifar/t (his box if you attach a continuation sheet. 4. Impurities ia) List each impurity, including CAS Registry Number, which may reasonably be anticipated to be present in the chemical substance as it will be manufactured for commercial purposes, (b) Estimate the maximum percent (by weight) of each impurity. Base your answer on information developed during R & D activities, your knowledge of manufacturing process chemistry and anticipated quality control operations. (c) Mark IX) if the Concentration of an impurity will be specifically controlled because of your concern about potential adverse health or environmental effects, (d) Estimate the maximum total percent (by weight) of the impurities that may be present. Impurity and CAS Registry number la) * Maximum percent present (b) ft Mark if to be specifically controlled 1C) Confiden tial code *b % ft ft ft % % 4b - d. Total percent -- - Q Mark this box il you attach a continuation sheet. % Section C - GENERIC NAMES Complete this section only if Specific Chemical Identity is claimed confidential. For instructions on how to develop generic names, see appendix II, 40 CFR 720 (44 FR 2278), Proposed ______________ Premanufacture Notification Requirements and Review Procedures,_________ _________ l. Enter the generic name agreed on by EPA in Prenotice Communication or provide 3 generic names. Page 4 59792 Federal Register / Vol. 44, No. 201 / Tuesday, October 16.1979 / Proposed Rules Section D - PRODUCTION AND MARKETING DATA If you claim Production Volume confidential, mark (X) the box at the right.----------------------------The answers to item 1 will be included in this claim. - 1. Estimate the minimum and maximum annual production volume for the first three years of production. Include in your estimates production by others with whom you have contracted to manufacture the new chemical substance. Production year (1) Minimum (2) Production (Kg/yr) ' Maximum (3) a. First year b. Second year * Confiden tial code c. Third year 2. Category of use If you claim Use Data confidential, mark (X) the box at the right.---------------------------------------------The answers to item 2 will be included in the claim. a. List the category!iesl of use on which you have based your production estimates. (Example: solvent used in automotive paint.) List partial information if complete information is not known. (Example: solvent.) Mark (X) the categories of use as site limited, industrial, commercial, or consumer. Estimate the percent of total production for the first 3 years devoted to each category of use. Category of use (1) Production percent (2) Site limited (3) Mark (X) appropriate cotumn(s) Industrial (4) Commercial (5) Consumer (6) Confiden tial code % % Mark this box II you attach a continuation sheet. b. List any other category(ies) of use that you have actively explored bV...... Mark this box II you attach a continuation sheet. c. Do you intend or expect the new chemical substance to be used to treat drinking water supplies or to be used in products (e.g., paints or coatings) that will come in contact with drinking water? 1 Yes 2 f~l No 3 QJ Don't know NOTE - If you claim the answers to items 3 or 5 confidential, place the letter(s) A-F in the box which indicates the basis of your claim and answer the linkage questions in appendix A, section II for categories A--E. If you claim any item submitted in an attachment confidential, see SPECIAL INSTRUCTIONS, appendix A, section II, part B. 3. Has the chemical substance been manufactured before? 1 Yes 2 No 3 Q] Don't know 4. Hazard warnings Attach to this notice a copy or reasonable facsimile of any hazard warning statement, label, labeling, marking or instructions, technical data sheet, material safety data sheet, and any other information which will be provided to any person regarding the safe handling, transport, use. disposal, treatment upon accidental exposure, or the formulation, construction, or labeling of products containing the new chemical substance. 1 1 Mark this box it you attach a hazard warning. S. Enter the number of customers who have either contracted to purchase, submitted a purchase order, or made any other firm commitment to purchase the new chemical substance from you for a category of use unknown to you. Estimate the percentage of your production volume that will be purchased by such customers during the first 3 years of production. Page 5 Number of customers Percentage production volume Confiden tial code % Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules 59793 k Section E - TRANSPORT Complete this section if you intend to ship the new chemical substance from its site of manufacture. If you claim the answers to items 1 or 2 confidential, place the letter(s) (A--F) in the box which indicates the basis of your claim and answer the linkage questions in appendix A, section II for categories A--E. 1. Enter the proper DOT shipping name and hazard class of the new chemical substance (if applicable). a. Shipping name Confiden tial code b. Hazard class 2. Mark (X) the mode(s) of transport which you believe will be used for the new chemical substance. 1 | ) Truck 2 C1 Railcar 3 [_ j Barge, vessel . 1'] Pipeline 5 Plane 6 0] Other - Specify, k Section P - RISK ASSESSMENT If you claim any item submitted in an attachment confidential, see SPECIAL INSTRUCTIONS, appendix A, section II, part B. If you have evaluated the health or environmental risks which may be presented by the manufacture, processing distribution in commerce, use, or disposal of the new chemical substance attach your evaluation. . ' I~~l Mark this box it you attach a risk assessment. k Section G - DETECTION METHODS It you claim the answers to item 1 confidential, place the letter(s) A-F in the box which indicates the basis of your claim and answer the linkage questions in appendix A, section II, for categories A-E. 1.1$ an analytical method available to identify and quantify the presence of the new chemical substance - a. In workplace air? Identify In workplace air? Quantify Confiden tial code i Q] Yes No 3 j j Don't know i 0J Yes 2 0] No 3 0] Don't know b. In effluent streams? 1 "1 Yes 2 [0 No c. In materials requiring disposal? i 0j Yes 2 0] No d. In end products for which the new substance is an intermediate? i PJYes 2 Q No 30 Don't know f. In effluent streams? 3 [0] Yes 2 0] No 3 0] Don't know f. In materials requiring disposal? 110] Yes - 2 0] No h. In end products for which the new substance is an intermediate? 3 Don't know 1 [0 Yes 2 0] No Page 6 3 0] Don't know 3 0] Don't know 3 0] Don't know 59794 Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules Part II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE ^ Section A - INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER If you claim Process Information confidential, mark (X) the box at the right The answer to subsection 2 will be included in this claim. If you claim the answers to items in subsections 1, 3, or 4 confidential, enter the letter(s) A-F in the box which indicates the basis of your claim and answer the linkage questions in appendix A. section II for categories A--E. If you claim the answers to items 3.3, 4.3, or 4.4 in subsections 3 or 4, or any items submitted in an attachment confidential, see SPECIAL INSTRUCTIONS, appendix A, section II, part B. Complete a separate subsection 1 and subsection 2 sheet for each site where you will manufacture, process or use the new chemical substance. ^Subsection 1 - PROCESS INFORMATION Confiden tial code 1.1 Identity of site Name Physical location address (Number and street) City, County, State, ZIP code 1.2 Type of site r [_] Manufacturing z Q Processing 3 Use 4 Q Continuous s Q Batch 1.3 Hours of operation Days per year Hours per day 1.4 Amount manufactured, processed, or used -- Minimum Kg/yr. Maximum Kg/yr. Subsection 2 - BLOCK DIAGRAM 2.1 Provide a block diagram identifying the major unit operations and chemical conversions. Also include: a. For each chemical conversion in the block diagram identify the major chemical reactions and the major side reactions. b. Provide the approximate mass of all feed materials, byproduct materials, and products which are entering and leaving each major unit operation and chemical conversion. Indicate the method of transfer of these materials and whether the operation is open or closed to the workplace environment. e. Identify those points in the block diagram from which there will be releases of the new chemical substance or byproduct materials into the air, land, or water environment. [ 1 Mar* this box II you attach a continuation sheet. Page 7 Podaral Register / Vol. 44. No. 201 / Tuesday, October 16,1979 / Proposed Rules 59795 Subnotion 3 - OCCUPATIONAL EXPOSURE Complete a separate subsection 3 (or each site at which you will manufacture, process, use, or dispose of the new chemical substance. Indicate the anticipated routeis) of exposure to the new chemical substance te.g., inhalation, ingestion, dermal), the number of employees anticipated to be exposed by each route, and the maximum duration of such exposure (in days per year and hours per day). In the table below, mark (X) A-Average or P-Peak lor the concentration levels that are expected to be present in the immediate vicinity of the process equipment. Base your answer on maximum annual production, processing, or use during the first 3 years of manufacture under normal operating conditions with all engineering safeguards in place. 3J Identity of site Name Physical location address (Mumper and street) City, County, State, ZIP code | Confiden-1 tial code 3 J Occupational Exposure at Industrial Site Activity (IT a. Manufacture b. Processing c. Use d. Disposal Exposure reutets) (2) Maximum number exposed Maximum duration (41 (3) Hr./day Days/yr. Unit of measure DppTM a 0 mg/ra3 Concentration (S) Mark (X) appropriate column A -- Average ___ P -- Peak 0-1 1-10 10-100 > 100 A PA P A P AP 'ppm 2 mg.'m3 i ppm z mg/tn3 1 Oppm 2 mg/m3 3.3 Describe those operations in which workers will be directly exposed to the new chemical substance. |-| Mark this box it you attach a continuation sheet. 3.4 Mark (X) as many of the physical states of the new chemical substance to which workers may be exposed in the workplace. 'Solid 3 Aerosol sQMist 7 Dust 91 I Other - Specify,^ 2 Gas j | Powder 6 Fume a Liquid _______________________ 3.S For each site of manufacture, list any other substances te.g., byproducts, co-products, feedstocks and intermediates) associated with the manufacture of the new chemical substance that may reasonably be anticipated to be present in the workplace and to which workers may be exposed. Provide the CAS Registry Number. Substance (1) . CAS Registry Number (2) Confiden tial code Confiden tial code O Mark this box it you attach a continuation sheet. Page 8 59796 Federal Register / Vol. 44. No. 201 / Tuesday, October 16.1979 / Proposed Rules Page 9 Federal Register / Vol. 44. No. 201 / Tuesday, October 16,1979 / Proposed Rules 59797 F Section B - INDUSTRIAL SITES CONTROLLED BY OTHERS Complete this section using your own forecasts, any information already obtained from other persona who may process, use, dispose of, or manufacture (under contract) the new chemical substance or any other information that is reason ably ascertainable. Complete a separate subsection 1 and subsection 2 for each site where you expect other persons to manufacture (under contract), process, use, or dispose of the new chemical substance. - If you claim the answers to the items in subsections 1, 3,-or * confidential, enter the letterfs) A-F in the box which indicates the basis of your claim and answer the linkage questions in appendix A, section il, for categories A-E. If you claim the answers to items in subsection 2. or item3.3 in subsection 3 confidential, see SPECIAL INSTRUCTIONS in appendix A, section II, part B. Subsection 1 - PROCESS INFORMATION Confiden tial code lO. Identity of site (Optional) Name Physical location address (Number and street) City, State, ZIP code County ^ Subsection 2 - PROCESS DESCRIPTION Briefly describe processing, use, or manufacturing operations conducted by others. Q Uerk this box It you attach a continuation sheet. Page JO 59798 Federal Register / Vol. 44, No. 201 / Tuesday, October 16.1979 / Proposed Rules Subsection 3 - OCCUPATIONAL EXPOSURE Complete a separate subsection 3 for each industrial site where you expect other persons to process, use, dispose of, or manufacture the new chemical substance. Indicate the anticipated routes of exposure to the substance (e.g.. inhalation, ingestion, dermal), the number of employees anticipated to be exposed by each route, and the maximum duration of such exposure (in days per year and hours per day). In the table below, mark (X) A-Average or P-Peak for the concentration levels that are expected to be present in the immediate vicinity of the process equipment. Base your answer on the maximum amount anticipated to be manufactured, processed, used, or disposed during the first 3 years of operation under normal conditions with all engineering safeguards in place. Confiden tial code I 3.1 Identity of site (optional) Name Physical location address INwrtoer and streetl City, State. ZIP code County 3.2 Occupational Exposure at Industrial Site Activity (11 a. Manufacture b. Processing c. Use Exposure route(s) (2) Maximum number exposed (3) Maximum duration (4) Hrs./day `Days/yr. 1 1 l 1 1 1 Unit of measure 1 Qppm 2 | 1 mg/m* t ppm 2 mg/m* Concentration <S> ___ Mark (X) appropriate column A - Average P - Peak 0-1 1-10 10-100 > 100 A P AP A P A P ' 1 1 1 1 0ppm 2 0 mg/m* d. Disposal 1 1 1 1 0 PPm 2 0 mg/m* 3.3 Describe those activities in which workers will be directly exposed to the new chemical substance. * " \ Mark this box if you attach a continuation sheet. 3.4 Mark (X) as many of the physical states of the new chemical substance to which workers may be exposed in the workplace. iQ Solid a Q Aerosol 5 Q Mist 7 0 Dust 9 Other - Specify^ I Gas 4 0 Powder 6 Q Fume a 0 Liquid __________ - Page 11 Confiden tial code Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules 59799 Subsection 4 - ENVIRONMENTAL RELEASE AND DISPOSAL Complete a separate subsection 4 for each site where other persons intend to manufacture, (under contract) process, use, or dispose of, the new chemical substance. 4.1 Identity of site (Optional) Name physical location address (Number end street) | Confiden tial code I City, State, ZIP code County 4.2 Indicate the duration of release into the air and water environment and the annual amount of new chemical substance released to the air, water, and land. Mark (X) the disposition of the water discharge and estimate the effluent flow rate from the site. Enter the name of the POTW or receiving water body. Base your answer on maximum annual production during the first 3 years of manufacture under normal operating conditions. . Media (1) Duration of release Hrs./day (2) Days/yr. (3) Amount of new chemical substance released (Kg/yr.) Less than 10 (4) 10 100 (5) 100 1000 (6) 1000 10,000 (7) More than 10,000 (8) a. Air b. Land ;. ' :* ............ --' c. Water 1 POTW (Publicly Owned Treatment Works) 2 Q] Navigable waterway 3[71 Other Enter nemo, * d. Effluent stream flow rate . - ' Gallons per day 4.3 (1) List any byproduct materials containing the new chemical substance that are generated during manufacturing, use, and processing operations and which are disposed of (e.g., landfill, incineration, or other physical /chemical treatment). Water effluent and air emission streams should not be listed here. Estimates of release of the new chemical substance contained in such streams are required to be reported in item 4.2. (2) Indicate the method of disposal. (3) Estimate the amount of each material generated (Kg/Kg of the new chemical substance), and (4) estimate the percent (by weight) of the new chemical substance. Material requiring disposal (1) ' Anticipated method of disposal (2) Amount (Kg/Kg) (3) Percent of new chemical substance (4) Confiden tial code CD Mark this box II you attach a continuation sheet. Page 12 59800 Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules ! Section C - CONSUMER AND COMMERCIAL USER EXPOSURE Complete this section tor all consumer and commercial categories o( use which involve use of a product that intentionally contains the new chemical substance. Provide the information based on your own forecasts, information already obtained from other persons, or any other .information that is reasonably ascertainable. If you claim the answers to item 1 confidential, enter letterfs) A--F in the box which indicates the basis of your claim and answer the linkage questions in appendix A, section II, for categories A-- E. If you claim the answers to items 2. 3, or 4 confidential, see SPECIAL INSTRUCTIONS, appendix A, section II, part B. L. Complete the table below. For each consumer and commercial use category reported in section 0, item 2, mark fX) if the induct will be manufactured by the submitter or by other persons. Indicate the maximum number of consumers or commercial usaci expected to-be-exposed, the expected routes-of human exposure end the .frequency of exposure. Category of use from pmtitl, section D (1) Use category (2) Manufactured by - (3) Consumer Commercial Submitter Other .Exposure .routefs) (4) Maximum number exposed (5) Frequency of exposure (B) Daily Weekly Monthly Yearly Confldentlal code * - 2. Attach any estimates that have been developed of potential exposure-levels ior each category of use. Ofwfr(fft/s*ox It you attach any estimates. 3. For each product containing the new chemical substance, explain any aspect of its construction or formulation which you believe will limit the potential for exposure to the new chemical substance. For mixtures, indicate the maximum percent by weight of the chemical substance in the product. ' Mark this box It you attach a continuation sheet. 4. Identify any byproducts which are formed as a-result of each category of use described in this section. DMark this box it you attach a continuation sheet. Page 03 Federal Register / Vol. 44, No. 201 I Tuesday. October 16.1979 / Proposed Rules 59801 Port III - LIST OF ATTACHMENTS Undei section 5(d)(1)(B) and (C) of TSCA and 40 CFR 720.23, a manufacturer must submit all test data in his possession and control, and a description of any other data that are known to or reasonably ascertainable by him/her concerning the effect of manufacture, processing, distribution in commerce, use. or disoosal of the new chemical substance on health or the environment. The regulations specify which data must be submitted with the notice and which data may be referenced by literature citations. Using the categories provided, identify (1) attachments containing test data, descriptions of data, or literature citations in accordance with 720.23: (2) other attachments required to be submitted with this notice; (3) confidentiality substantiations and (4) attachments which contain information voluntarily submitted. All attachments should be clearly identified and numbered. To assert and substantiate a claim of confidentiality for any information included in the following attachments, follow the instructions in Appendix A, section II, part B. Note - Special directions for test data or other "Health and Safety" studies included in section III, part C. The instructions provide that you must also submit a "sanitized'' copy of the attachment with all information that you are claiming confidential deleted. EPA will place this copy in the public docket. a. Physical and chemical properties data Attachment name -' j Attachment number i I i - -- ]" , i i i i1 1 i' b. Health and i environmental i effects data ------------------------------------------------------------------------------------------------------------------------------- j----------------------------------------- ^ ' C' attachments * .i i 1 1 1 1 1 1 ! i j1 Part j Section/Subsection ] Item | 11 11 1i 1 t1 1I 1' :1 !! ! ti 1 1j 11 :| _ d. Confiderv tiality attachments e. Voluntary attachments .. i i 11 1 [ * i .. . i ! t I '` i 1 I j ! i ' t t i ! j 1 ; 1 1 1 1 j O Mark this box it you attach a continuation sheet. Page 14 ? 59602 Federal Register / Vol. 44, No. 201 / Tuesday, October 16.1979 / Proposed Rules Part IV - FEDERAL REGISTER NOTICE Information provided in this part will be published in the Federal Register rn accordance vrtth section S(dH2) of TSCA. Do not enter any information in this part for which you have asserted a claim of confidentiality. Section A - CHEMICAL IDENTITY " Enter the specific chemical name of the substance if it is not claimed confidential. If the chemical identity is claimed confidential, enter the name agreed to by EPA in Prenotice Communication:or EPA will enter one of the three proposed generic names in part I, section C. k Section B - MANUFACTURER IDENTIFICATION ~ Enter the legal title of the organization filing this notice if it is not claimed confidential. If the legal title of the organization is claimed confidential, provide a description of the organization in accordance with section III, Appendix A, Instructions for Asserting I and Substantiating Claims of Confidentiality. ^ Section C - USE DATA ' I 1. If use data were not claimed confidential in section D, list the categories) of use that you reported in section D, item 2a. I Mark (X) if the use categories) is site limited, industrial, commercial, or consumer. Category-of use (11 Site limited (2) Mark (X) appropriate box Industrial - Commercial (3) > Consumer <> 2. If use data were claimed confidential, provide a description of the category of use(s) of the chemical substance in accordance with section II, Appendix A, Instructions for Asserting and Substantiating Confidentiality. This description should be as specific as ' possible-without revealing confidential information. Section - TEST DATA List all test data concerning health and environmental effects of the manufacture,Processing, distribution, in commerce, use. or disposal of the new chemical substance that are being submitted, described, or cited as part of this notice. Provide a brief abstract of all test data on the new chemical substance that are submitted in accordance with 720.23(a) and 720.200). If physical-chemical properties are claimed con fidential, provide a generic description of these properties in accordance with section III, Appendix A, Instructions for Asserting and Substantiating Claims of Confidentiality. Mark this box It you attach a continuation sheet. Page 15 FnHoral Regiater / Vol. 44, No. 201 / Tuesday. October 16,1979 / Proposed Rules APPENDIX A INSTRUCTIONS FOR ASSERTING AND SUBSTANTIATING CLAIMS OF CONFIDENTIALITY INTRODUCTION These are the instructions for asserting and substantiating claims of confidentiality for any information you submit in a premanufacture notice (PMN). You may request confidential treatment for any item of information you submit in a PMN, whether it is entered on the PMN form or in attachments to the form. To make this request, you must follow the procedures set out in these instructions. More specifically: 1. You must assert a claim of confidentiality, identifying the information that you claim to be confidential. You must do this in accordance with these instructions, at the time you submit the PMN. Any information you do not claim as confidential will be included in the PMN public record without further notice to you. . 2. You must substantiate your claims of confidentiality. You must do this in accordance with these instructions, at the time you submit the PMN. Otherwise, EPA may determine that you have waived your claims, and may then release the information in question, in accordance with section 720.40(c)(2). 59803 59604 Federal Register / Vol. 44. No. 201 / Tuesday. October 16,1979 / Proposed Rules 3. For some of the items contained Ln the PMN, you must provide a non-confidential, generic (i.e. less specific) substitute for the information you claim to be confidential. In providing generic substitutes you must follow the instructions in this Appendix. Otherwise, EPA will develop its own -generic substitutes, which it will publish after giving you notice. This third requirement applies to: - The identity of the ccmpany submitting the notice; - The specific chemical identity of the new chemical substance: - The proposed categories of use of the substance: and - Certain physical and chemical properties of the substance. If you assert a claim of confidentiality and you substantiate that claim, EPA will disclose the information only, as provided in the Agency's confidentiality regulations which appear in 40 CFR Part 2. Those regulations include provisions stating that, with specific exceptions, EPA will maintain the confidentiality of information claimed as . confidential until the EPA General Counsels Office makes a final determination that certain information is not entitled to confidential treatment: and that if confidentiality is denied, the submitter will receive written notice 30 days before the date EPA will make the information available to the public. Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules ORGANIZATION OF THESE INSTRUCTIONS These instructions are organized as follows: - Section I describes six "categories" of confidentiality claims. The categories will apply to all claims, both those for items on the form and those for any information submitted separately as attachments. - Section II - A explains how to assert a claim of confidentiality for information on the PMN form, and describes the steps you must take to "link" individual claims to the appropriate categories described in Section I. - Section II - B explains how to assert a claim of confidentiality for information in attachments to the PMN form, and includes special instructions for asserting a claim for information in health and safety studies. - Section III identifies the items in the PMN for which you must develop generic substitutes, and provides a method for creating these substitutes. - Section IV describes how to provide the required substantiation for each of the five specific categories of information in which you have asserted a claim of confidentiality and for each . piece of information that is claimed confidential which is not "linked" to the five specific categories. - 'Section V describes the format for answering linkage and substantiation questions, and for justifying generic substitutes which are not developed in accordance with the instructions provided in Section III. 59805 59806 Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules I. CATEGORIES OF CLAIMS EPA has identified five categories of information into which most confidentiality claims will fall: Category A; Manufacturer's (Importer's) Identity Category B: Specific Chemical Identity Category C: Production Volume Category D: Uses of the New Chemical Substance Category E: Process Information You may wish to claim confidential treatment for information that does not fall under any of the categories A-E. These claims will be referred to in these instructions as "Category F" claims. The instructions that follow explain how these six categories are to be used. . II. ASSERTING CONFIDENTIALITY CLAIMS A. Use of the Categories to Assert Claims of Confidentiality for Information on the Premanufacture Notice Form There are two ways to assert claims of confidentiality on the form. The first may be used for items that EPA has "linked" to one of the categories A-E. The second way must Federal Register / Vol. 44. No. 201 / Tuesday, October 16,1979 / Proposed Rules be used for items that you have to link to one of these categories, or that you claim as a "category F" item. The instructions for each of these two ways of asserting claims follow. (1) Linkages Identified by EPA To assert a claim of confidentiality for any item on the PMN form in Column 2 (below) you must mark the box on the form next to that item. (EPA has already determined the category linkages for these items, as indicated under Column 1.) However, if the basis of your claim of confidentiality for any of the items listed in Column 2 does not correspond with the linkages given in Column 1, then you must use the procedures in the following section, "Linkages that You Must Indicate and Establish", to assert your claim. Column 1 . Column 2 Category Identified Linkages A: Manufacturer's (Importer's) Identity Part I, Section A, items 1,2, & 3 B: Chemical Identity Part I, Section B, C: Production Volume items 1,2, & 3 Part I, Section D, item 1 D: Use Data d : Process Information- Part I, Section D, item, 2 Part II, Section A 59807 59808 Federal Register / Vol. 44. No. 201 / Tuesday, October If). 1979 / Proposed Rules Subsection 2 F: Other NONE (2) Linkages that You Must Indicate and Establish If you wish to claim confidentiality for any information not listed in Column 2 above, first you must indicate the category of information -- that is, in which of the categories A-F the item falls. To do this you must place the appropriate category letter(s) in the box next to the information you claim to be confidential. By doing this, you indicate the basis of your confidentiality claim. Second, if you assert a claim by linking an item to one of the categories A-E, you must explain why the item would reveal information in that category. You must do this for each item, by answering the appropriate "linkage" questions below. If you assert a confidentiality claim in category F because disclosure would reveal other confidential information that is not in any of the categories A-E, you do not have to answer any linkage questions. Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules Linkage Questions 59809 A: Manufacturer's (Importer's) Identity Foe every item that you have marked with an "A", answer the following question: How would disclosing this item reveal your company's identity? B; Specific Chemical Identity For every item that you have marked with a "B", answer the following question: How would disclosing this item reveal the specific chemical identity? ' C: Production Volume For every item that you have marked with a "C" , answer the following question: How would disclosing this item reveal production volume? D: Hse Data For every item that you have marked with a "D", answer the following question: How would disclosing this item reveal the use(s) of the new chemical substance? E. Process Information . For every item that you have marked with an "E", answer the following question: How would disclosing this item reveal process information? 59810 Federal Register / Vol. 44. No. 201 / Tuesday, October 16,1979 / Proposed Rules Q. Asserting Claims of Confidentiality for Information In Attachments to the PMN Form -* To assert a claim of confidentiality for information in attachments to the PMN form, you must: - Provide a complete copy of the attachment which (i) clearly indicates (e.g., by circling, underlining, bracketing) the information you wish to claim confidential, and (ii) identifies with a letter A-P the category on which your claim is based. (You should make clear to what information a particular letter refers.) - Answer the appropriate linkage questions for each item claimed confidential in categories A-E. - Submit a sanitized copy, deleting all the information that you claim as confidential on the original document. The sanitized version will be placed in the public docket. C. Special Directions for Attachments Containing Test Data or Other "Health & Safety Studies" In general, you must assert a claim of confidentiality for information in health and safety studies in the same manner as for other attachments. However, when identifying the category on which a claim is based, you may find it necessary to claim an item confidential because it reveals confidential information on the portions of chemical substances in a mixture. For purposes of Health and Safety studies only, you should identify this information with an -i.t * Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules M". Each time you indicate this reason for asserting confidentiality, you must answer the following linkage question: (low would disclosing this information reveal the portion of any chemical substance in the mixture? You may claim any data included in test data or health and safety studies confidential for any.reason. However, in accordance with EPA's interpretation of section 14(b) of the Act, the Agency will deny confidentiality claims for any item not shown to reveal information in one of the following categories: . ' - specific chemical identity of the chemical substance (a claim on this basis alone will be upheld only until manufacture of the substance begins) - process information - portion of a mixture comprised by any of the chemical substances in the mixture - other items of information such as manufacturer's identity, cost or financial data, marketing plans, only if they are unrelated to the health and safety effects of the substances. (Information on the methodology of the test and its results does not fall within this exception.) III. PROVIDING GENERIC SUBSTITUTES FOR CERTAIN . INFORMATION ASSERTED TO BE CONFIDENTIAL Certain information submitted on the form or in ' 59811 59812 Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules attachments is particularly important for public participation in the assessment of new chemical substances. However, much of this information may be subject to claims of confidentiality. To balance these interests, EPA requires you to either provide generic (i.e. less specific) substitutes for certain items you claim confidential, ojr to explain why nonconfidential generic information cannot be developed. EPA will review the generic substitute or the explanation and notify you of its decision. After notifying you, EPA will make public the chosen non-confidential generic description. Note: You must provide EPA the specific information requested on the form. The generic substitute is for public disclosure. It should not be used as a substitute for any of the items on the form. Generic substitutes are for the following: - If you assert a claim of confidentiality for specific chemical identity (Part I, section B of the form) you must provide three generic names in Part I, section C in accordance with the EPA Guidelines for Creating Proposed Generic Names for Confidential Chemical Substance Identities for Premanufacture Notification. EPA will select one generic name to publish in the FEDERAL REGISTER notice. - If you assert a claim of confidentiality for category of use (Part I, section D of the form), you must provide generic use information for Part Federal Register / Vol. 44, No. 201 / Tuesday, October 16.1979 / Proposed Rules III of the form In accordance with these instructions., EPA will publish the generic information in the FEDERAL REGISTER notice. - If you submit (in an attachment) data on the new substance's vapor pressure, density, solubility, melting point, or boiling point/sublimation point, and if you assert a claim of confidentiality for such data, you must provide the data in the ranges specified in these instructions. These ranges will be placed in the public docket. - If you assert a claim of confidentiality for manufacturer*s identity (Part I, section A of the form) you must develop a description of the manufacturer for Part III of the form in accordance with these instructions to be published in the FEDERAL. REGISTER notice. ... - . ....... The instructions for developing these four kinds of : generic information follow. . . A. Instructions for Generic Chemical Identity Names " If (but only if) you claim specific chemical identity confidential and you have not agreed with EPA on a generic name during prenotice communication, you must provide three generic names to be included in the FEDERAL REGISTER notice. Part III, Section A, of the PMN form. These names must be provided in accordance with the Guidelines for Creating Proposed Generic Names for Confidential Chemical Substance 59813 59814 Federal Register / Vol. 44, No. 201 / Tuesday, October 18,1979 / Proposed Rules Identities for Premanufacture Notification. ' B. Instructions for Generic Descriptions of Manufacturer's Identity If you have claimed your company's identity confidential, use the following scheme to develop a generic description of the company identity for inclusion in the FEDERAL REGISTER notice, Part III, section B of the PMN form. Instructions for Selection of Characteristics Select from List 1, Geographic Location of the Company, the region of the country in which the intended site of manufacture is located. If you do not know the site, identify the region in which your company's headquarters is located. Select from List-2, Size of Company in Total Annual Sales, the category in which your company's total annual sales figure fall. This figure should be based on the company's latest complete fiscal year and should reflect the entire corporate entity. Identify the three-digit Standard Industrial Classification (SIC) Code for the manufacturing site. If you do not know the site, identify the primary SIC code for the entire company. If the three-digit code will reveal the company's identity taken together with the information on geographic location and annual sales, provide a two-digit code and a brief explanation of why a three-digit code is Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules Once you have selected the appropriate characteristics, you may use them to write a generic manufacturer identity description. Alternatively, you may select the characteristics and enter them in the spaces provided on the form. In this case, EPA will compose the generic manufacturer identity based upon the selected descriptors. The following example is provided as a suggested format for composing generic manufacturer identity descriptions. If the Agency composes any descriptions, it will follow this format. Example: .ABC Chemicals Company has corporate headquarters in Chicago, Illinois, with total annual sales of $87,500,000. It intends to produce the new substance at its plant in Los Angeles, California, which has SIC code 2861. The company's general description would read as follows: "The submitter has total annual sales of between $10,000,000 and $99,999,999, and intends to produce the new chemical substance at a plant in the Pacific region of the country whose three-digit Standard Industrial Classification code is 286, "Industrial Organic Chemicals". 59815 59816 Federal Register / Vol. 44, No. 201 / Tuesday, October 16.1979 / Proposed Rules List of Characteristics List 1 Geographic Location of the Company Region Northeast: Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont Middle Atlantic: New Jersey, New York, Pennsylvania East North Central: Illinois, Indiana, Michigan, Ohio, Wisconsin . West North Central: Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, South Dakota South Atlantic: Delaware, District of Columbia, . Florida, Georgia, Maryland, North Carolina, South Carolina, Virginia, West Virginia East South Central: Alabama, Kentucky, Mississippi, Tennessee West South Central: Arkansas, Louisiana, Oklahoma, Texas Mountain: Arizona, Colorado, Idaho, Montana, Nevada, New Mexico, Utah, Wyoming Pacific: Alaska, California, Hawaii, Oregon, Washington List 2 Si2e of Company a) under $1,000,000 b) $1,000,000 to $9,999,999 c) $10,000,000 to $99,999,999 d) $100,000,000 to $499,999,999 e) $500,000,000 and up Federal Register / Vol. 44, No. 201 / Tuesday, October 18,1979 / Proposed Rules C. Instructions for Generic Use Information If (but only if) you claim the categories of use or intended uses of the substance confidential, you must use the following method to develop generic use information to be included in the section 5(d)(2) FEDERAL REGISTER notice. Part III, section C, of the PMN form. 59817 Select from List 1, Degree of Containment, the ' characteristics which describe the degree of containment of the substance. Some examples are included in List 1, to help explain the meaning of the terms. Most industrial uses of chemicals will fall in the "open use" or "dispersive use" categories. Most consumer uses will be classified as . "highly dispersive". If no characteristic is appropriate, provide an appropriate term on the line marked "other". Select from List 2, Level of Environmental Release, one characteristic to represent the total loss to the environment due to the use. Total loss includes losses from commercial and industrial waste streams and fugitive emissions, consumer end use, and final consumer disposal as solid waste. Select from List 3, Type of Population Exposed, the characteristic which describe each type of population that may be exposed to the substance due to its use. Many uses will involve some commercial or industrial exposure as well as some consumer exposure. In the case of some printing inks, for example, the press operators are exposed to them 59818 Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules as are the consumers who handle the printed material. In these cases, more than one type of population characteristic should be chosen for each category of use or intended use. Select from List 4, Environmental Release, the necessary descriptors for each type of release to the environment due to the use. Only identify the releases that give information about the use of the substance. For example, using an industrial coating on furniture production may involve some release of spent lacquers to a landfill. However, during the use of the substance, release would result from the evaporation of solvents from the coatings. In this case, you would report the releases as an industrial or commercial loss or waste stream to the air, but not a release to a landfill. Some releases, particularly some industrial releases, may not give any information about the use. In these cases you should choose descriptor (e). For each type of population identified above, select as many descriptors as appropriate from List 5, Type of Human Contact. . For each type of population identified above select one descriptor from List 6, Frequency of Use or Human Contact. Most consumer uses will imply an average frequency of use. For example, dishwashing detergents may be used an average of five times per week. Industrial and commercial uses may differ, since discrete occurrences of use are replaced by frequent or perhaps continuous exposure to substances which are used daily. Either type of use can be classified by the . - Federal Register ./ Vol 44. No. 201 / Tuesday, October 16,1978 / Proposed Rules descriptors in List 6. Group the descriptors from List 5 and 6 according to the exposed populations identified. Once you have selected the appropriate characteristics, you may use them to write narrative generic substitutes for the use information you claim confidential. Alternatively, you may select the characteristics and enter them in the space provided on the form. In this case, EPA will compose the narrative generic substitute based upon the selected descriptors. The following example is provided as a suggested format for composing narrative generic substitutes for use information. If the Agency"composes any generic substitutes, it will follow this format. Examplet The premana fact-ure notice indicates that the substance will be used in an open use that will release more than 50 kilograms but'less than 5,000 kilograms of the substance to the environment per year. The manufacturer states that the use will involve exposure to non-chemical industry employees more than five times per week with intended skin contact and a potential for eye contact'. The use will also involve exposure for consumers as part of an article with an average exposure frequency of once a month or less and a potential for skin and eye contact. There will be release to the environment as an industrial loss to the air and in an industrial waste stream to a Publicly Owned Treatment /7or?<s (POTW) as well as release to the air from a consumer end use. 59819 59820 Federal Regiater / Vol. 44, No. 201 / Tuesday. October 16,1979 / Proposed Rules LIST OF CHARACTERISTICS List 1 Degree of Containment a) destructive use (e.g., fuels, fuel additives, chemical intermediates) - b) contained use c) open use (e.g., closed processes, fluids sealed in products) (cases somewhere in between dispersive uses and contained uses) d) dispersive use (e.g., some textile dyes, automobile tire rubber, friction devices) . e) highly dispersive use (e.g., pesticides, fertilizers, salt for snow removal, paint solvents) . f) other, please describe Federal Register / Vol. 44. No. 201 / Tuesday. October 16,1979 / Proposed Rales List 2 Level of Environmental Release a) less than 50 kg/year b) more than 50 kg/year but less than 5,000 kg/year c) more than 5,000 kg/year but less than 50,000 kg/year d) more than 50,000 kg/year ' List 3 Type of Population Exposed a) industrial employees - chemical b) ind us tried employees - non-chemical c) commercial employees - maintenance, services and retail sales d) consumers - formulated products te.g., mixtures) e) consumers - part of an article List 4 Environmental Release . AS an industrial or commercial loss or waste stream a) - to air b) - to water c) - to a Publicly Owned Treatment Works (POTW) d) - to a landfill e) - other, please describe Consumer end use f) - to air g) - to navigable waters h) - to a Publicly Owned Treatment Works (POTW) j) - final consumer disposal as solid waste 59822_________ Federal Register / Vol. 44. No. 201 / Tuesday, October 16,1979 / Proposed Rules List 5 Type of Human Contact a) - very low potential for contact b) - potential skin contact c) - potential eye contact d) - potential oral contact e) - potential inhalation f) - potential ingestion g) - intended skin contact h) - other, please describe List 6 Average Frequency of Human Contact a) - once a year or less . b) - once a month or less c) - once a week or less _ d) - more than once per week e) - five times per week f) - continuous or very frequent exposure during working hours g) - other, please describe D. Instructions for Providing Generic Physical and Chemical Properties You must use the ranges provided below for vapor pressure, density, solubility, melting point and boiling point/sublimation point if you claim these physical and chemical properties confidential because ' disclosing the "specific" value for any of them would Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules r"val confidential business information. If you do not use these ranges, provide a range of your own and explain why such an expanded or different range is necessary to protect the confidential business information. If you claim any other specific physical and chemical properties confidential, provide a range of your own choosing. This nonconfidential information will be placed in the public docket. P.anoes for Reporting Physical and Chemical Properties Vapor Pressure N 1 f t1 1 O Temperature [1 [ I io"2 - 1 [ 1 l-i- torr torr [ 1 10 - 100 t 1 100 - 1000 torr torr Densitv (liquid or Solidl t 1 >1000 torr I I <.9 gra/cc t 1 .9 - 1.1 gm/cc Solubility { 1 >1.1 gm/cc Temp Solvent [ 1 <1-6 gra/1 t 1 10`4 - 10"6 gm/1 [ 1 10~4 - 10"2 gm/1 t 1 10-2 -1 gm/1 [ 1 1 - 10 gm/1 [ ] >10 gm/1 Mol cinq Point ( r <0C" [ i 0 - 30C* t i 30 - 50C [ i 50 - 100C# l i >100C Boiling Point/Sublimation Point t j <0C* l i 0 -30C* [ i 30 - 50C ( j 50 - 100C 1 i 100 - 200C* t i >200C 59823 59624 Federal Register / VoL 44, No. 201 / Tuesday, October 16,1979 / Proposed Roles [V. SUBSTANTIATING CLAIMS OF CONFIDENTIALITY In addition to asserting a claim as explained in sections I - III of the instructions, notice submitters must do the following to substantiate claims of confidentiality for information on the PMN form or in attachments to the form. , A. GENERAL CERTIFICATION The person who signs the form must certify the truth and accuracy of the following four statements which apply to all information claimed confidential. (Note: The certification is only to be signed once for the entire form and attachments): a. My company has taken measures to protect the confidentiality of the information, and it will continue to take these measures; b. The information is not, and has not been, reasonably obtainable by other persons (other than governmental bodies) by using legitimate means (other than discovery based on a showing of special need in a judicial or quasi-judicial proceeding) without my company's consent; _ c. The information is not publicly available elsewhere; and d. Disclosure of the information claimed confidential would cause substantial harm to my company's competitive position. Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules B. CATEGORY A: Manufacturer's (Importer's) Identity To substantiate claims for Category A, Manufacturer's Identity, you need only sign the confidentiality *'*,* certification. You are not required to answer any specific questions for this category. C. CATEGORY B, C, D, E, and M: SPECIFIC QUESTIONS In addition to the certification, you must answer the following questions if you claim information confidential in f i these categories. (Note: for each category, you must lE answer the questions only once, regardless of the number of *5 i times you claim information confidential in that category.) j Category B - Specific Chemical Identity i 1. How would disclosing the specific chemical identity [5t substantially harm your competitive position? Be * specific about the connection between disclosure and the harm. '. \ 2. How long should confidential treatment be given (until a specific date, until the occurrence of a specific event, or permanently)? Why? 3. Has the chemical substance been patented? If so, have you granted licenses to others with respect to the patent? If the substance has been patented and therefore disclosed through the patent, why should it be treated as confidential? - 4. To what extent has it been revealed to others that this chemical substance is or will be manufactured or imported for a commercial purpose? What precautions 59825 Fadaral Ragiater / VoL 44, No. 201 / Tuesday, October lfl, 1979 / Proposed Rules have been taken regarding these disclosures? Have there been-public disclosures or disclosures to compe titors? 5. Has this particular chemical substance let your site in any form, e.g., as product, effluent, emission? If so, what measures have you taken to guard against discovery of its identity? Before you begin manufacture of this substance will it leave your site in any form? If so, what measures will "you take to guard against discovery of its identity? 6. If the chemical substance has left the site in a product that is available to the public or your competitors, can the substance be identified by analysis of the product? 7. Has EPA, another federal agency, or any federal court made any pertinent confidentiality determinations regarding this information? If so, please attach copies of such determinations. 8. If you have claimed confidentiality for manufacturer's identity (Category A) and EPA keeps confidential the link between your company identity and the specific chemical identity, your identity will not be associated in any way with the chemical identity. In this case, what harm to your competitive position would result from disclosing only the specific chemical identity? How could a Federal Register / VoL 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules competitor use this information? What is the casual relationship between the disclosure and the harm? Category C - Production Volume 1. If yoj have claimed confidentiality for manufacturer's identity (Category A) and EPA keeps confidential the link between your company identity and production volume/ your identity will not be associated in any way with the production volume. In this case, what harm to your competitive position would result from disclosing the production volume? How could a competitor use this information? What is the causal relationship between the disclosure and the harm? . 2. If you have claimed confidentiality for chemical identity (Category B) so that the chemical identity (other than generic name) is not associated in any way with production volume, what harm to your competitive position would result from disclosing the production volume? How could a competitor use this information? What is the causal relationship between the disclosure-and the harm? ` Category D - Use Data 1. If you have claimed confidentiality for . manufacturer's identity (Category A) and EPA keeps confidential the link between your company identity and the use data, your identity will not be associated in any way with the use data. In this 59827 59828 Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules case, what harm to your competitive position would result from disclosing the use data? How could a competitor use this information? What is the causal relationship between the disclosure and the harm? 2. If you have claimed confidentiality for chemical identity (Category B) so that the chemical identity (other than generic name) is not associated in any way with the use data, what harm to your competitive position would result from disclosing the use data? How could a competitor use this information? What is the causal relationship between the disclosure and the harm? Category E - Process Information ' 1. If you have claimed confidentiality for manufacturer's identity (Category A) and EPA keeps confidential the link between your company identity and process information, your identity will not be associated in any way with this information. In this case, what harm to your competitive position would result from disclosing the process information? How could a competitor use such information? What is the causal relationship between the disclosure and the harmful effects? 2. If you have claimed confidentiality for chemical identity (Category B) so that the chemical identity (other than generic name) is not associated in any way with the process information, what harm to your Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules competitive position would result from disclosing'the process information? How could a competitor use this information? What is the causal relationship between the disclosure and the harm? Category M; Portions of a Mixture (Only for use in Health and Safety Studies) 1. If you have claimed confidentiality for manufacturer's identity (Category A) and EPA keeps confidential the link between your company identity and the proportions of the mixture, your identity will not be associated in any way with this information. In this case, what harm to your competitive position would result from disclosing the proportions of the mixture? How could a competitor use this information? What is the causal relationship between the disclosure and the harm? 2. If you have claimed confidentiality for chemical identity (Category B) so that the chemical identity (other than generic name) is not associated in any way with the proportions of the mixture, what harm to your competitive position would result from disclosing the proportions of the mixture? How could a competitor use this information? What is the causal relationship between the disclosure and the harm? 59829 59830 Federal Register / Voi. 44. No. 201 / Tuesday, October 16,1979 / Proposed Rules D. CATEGORY F - OTHER INFORMATION - SPECIFIC QUESTIONS For Category Ff Other Information, you must answer the following questions each time you claim information confidential for that category: L. Is the item confidential in and of itself? If so, what is revealed by its disclosure? 2. Is the item confidential because it will reveal some other confidential information, whether or not that other information is reported on this form? If so, what is the information that will be revealed? 3. Is the item confidential because it will reveal other confidential information when the item is disclosed in association with some other item(s) submitted on this form? Is so, what are those item(s)? 4. If the answer to 1, 2, or 3 is yes, what harm would disclosing the confidential information cause to your competitive position? How would disclosure lead to this harm? 5. If you have claimed confidentiality for manufacturer's identity (Category A) and EPA maintains the confidentiality of the link between . your company identity and this information, your identity will not be associated in-any way with the item claimed. In this case what harm to your competitive position would result from disclosing the item? How could a competitor use this information? Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules what is the causal relationship between the 'UseLosure and the harm? *'.. [f you have claimed confidentiality for chemical identity (Category B) so that .the chemical identity (other than generic name) i3 not associated in any way with the item claimed, what harm to your competitive position would result from disclosing the item? How could a competitor use this information? What is the causal relationship between the . disclosure and the harm? V. FORMAT FOR RESPONSES TO LINKAGE AND SUBSTANTIATION QUESTIONS 'AND JUSTIFYING GENERIC SUBSTITUTES Any attachments to the premanufacture notice form that either (i) establish linkages to the EPA categories of claims, or (ii) substantiate information claimed confidential, or (iii) justify generic substitutes should follow the format described below: 1. The responses for any one category -- whether establishing a linkage, substantiating a claim of confidentiality, or justifying a generic substitute should be grouped together. For example, responses to linkage questions, substantiation questions and any explanation of why the EPA approach to developing generic substitutes was not used (if it was not , used), about the information in the use data category should be grouped together. 59831 59832 Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules . with your responses grouped by category, you should then arrange the groups in the order of the categories themselves, starting with A. For example, if category A (manufacturer's identity) and category D (use data) are claimed confidential, the responses in category D should all follow the responses in category A. An outline of your attachments if you make confidentiality claims in each of the categories might be the following: I. Category A Claims (Manufacturer's Identity) A. Answers to linkage questions. B. Justification of a generic substitute (only if you do not use EPA's guidelines for providing this information.) (To substantiate a claim of confidentiality for Manufacturer's Identity, sign the Confidentiality Certification statement - appearing on the front of the PMN form.) II. Category B Claims (Specific Chemical Identity) A.- Answers to linkage questions. B. Justification of generic description (only if you do not use EPA's guidelines for providing . . this information.) C. Answers to substantiation questions. III. Category C Claims (Production Volume) A. Answers to linkage questions B. Answers to substantiation questions Federal Register / Vol. 44. No. 201 / Tuesday, October 16.1979 / Proposed Rules Category D Claims (Use of the New Chemical Substance) A. Answers to linkage questions. B. Justification for generic description (only if you do not use EPA's guidelines for providing this information.) C. Answers to substantiation questions, v. Category E Claims (Process Information) A. Answers to linkage questions B. Answers to substantiation questions 71. Category F Claims (Other) A. Answers to substantiation questions for each item claimed in this category. EPA will treat as confidential the information provided to justify confidentiality claims, so long as this information is clearly marked CONFIDENTIAL. Appendix 'J Examples of Asserting and Substantiating Claims of Confidentialitv The following three examples are provided to illustrate how njbmitter would assert a claim of confidentiality. Example 1 - Manufacturer's Identity (Part I, Section A) Absolusol Company has filed a PMN. The company is asr-'-fing a claim of confidentiality for the company name because public disclosure of the fact that this company intends to manufacture a new chemical substance would reveal confidential business information. As illustrated on the att :hment, a check has been placed in the box to indicate 59833 59834 Federal Register / Vol. 44, No. 201 / Tuesday. October 16,1979 / Proposed Rules thn* the company is asserting this claim. The answers to Qu^-tions 1, 2 and 3 of Part I, Section A are automatically inr'uded in the claim of confidentiality for manufacturer's identity when this single box is checked. In accordance with EPA's instructions for claiming confidentiality for manufacturer's identity, Absolusol has pr'/ided EPA a generic description in Part III of the form wtv :h will be published in the FEDERAL REGISTER notice. (S'" attached sample page.) The company is also asserting a claim of confidentiality for the answer to Question 4, intended date >t. l, -tn,>n n nf manufacture fur commerc ia l ' purposes. The com* my has placed an "A" in the box next to Question 4 ho-- "me the company is asserting that disclosure of this ini tmat ion will reveal the company identity. The company expliim how disclosure of the answer to question 4 will rev il company identity by responding to the linkage qur > ion found in the instructions. To substantiate the claim of confidentiality for all cat-'jory A claims, Samuel Hunter, President of Absolusol Commny, has signed the confidentiality certification statement appearing on the front of PMN form. No other suh-Mntiation is required for claims in this category. Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules 59835 PrtOHFOHivI *>EPA United States Environmental Protection Agency PREMANUFACTURE NOTICE DOMESTIC MANUFACTURERS , When completed tend this torn to; Document Control Officer Office of Toxic Subatancea, TS.713 U.3.E.P.A. 401 M Street. S.V. WashIn (ton, O.C. 20440 EPA USE ONLY Oats of receipt GENERAL INFORMATION Tie Premanufacture Notice form divided into the following pan ;tic manufacturers is Part I - General i Part II - isntal Release Pwt III Pirt IV - F< lister Notice Part V - Optional Data The optional part (part V) is not included in this package. All data requested in the mandatory parts (parts I, II, 111, and IV) must Pe reported to the extent they are known to or reasonably ascertainaoie by the submitter. This means that the submitter is exoected to answer all questions ta the best of his/her ability, including making reasonable estimates in cases where comoiete factual information is not available. If the submitter is unable to make a reasonable estimate (i-e., the data is not known and is not teasonaoly ascertainaoie), he/ihe should enter "NA" (not available). In part I, the submitter is required to report me specific chemical identity of the new substance, regardless of whether the informa tion is claimed as confidential. In accordance with proposed 5720.20(f), the submitter may authorize another person to report the specific chemical identity in his/her behalf. The notice net be valid until the specific chemical identity ia recety EPA. If the space on the form is not sufficient to idequetAj^rtSL . dilution, the submitter may attach additional shCtg.\jdanjif> continuation oy part, section, subsection, ASSERTING AND SUBS'UWr\vNa}N` CLAIMS OF CONFIDElWaUTTW ____ Road Aooendix A. Instructions for Asserbtr^ and Substantiating Claims of confidentiality, for information on how to claim and substantiate confidential busineu information included in this foim or in attachments a the form. Claims of confidentiality must be made in accordance witn sections) and IIof these instruc tions. In addition, substantiation of all claims of confidentiality must be made in accordance with section IV of these instructions. If you claim any item in any attachment to this form confidential, see SPECIAL INSTRUCTIONS for attachments. Appendix A, Section II. Appendix B "Examples," provides additional guidance for asserting and substantiating claims of confidentiality. In accordance with sections I and II of the confidentiality instruc tions, claims of confidentiality must be made by using the follow* ing six categories: . A. MANUFACTURER'S IDENTITY A claim of confidentiality for Category A . Manufacturer's identity, automatically includes items 1, 2, and 3 in parti. section A. B. SPECIFIC CHEMICAL IDENTITY A claim of confidentiality for category 8. Specific Chemical Identity, automatically includes items 1, 2, and 3 in part I, section B. _ C. PRODUCTION VOLUME A claim of confidentiality for category C. Production Volume automatically includes item l in part I, section 0. These items do not need to be individually claimed. D. USE DATA A claim confidentiality for category D, Use Oats, automatically includes item 2 in part I, section 0. These items do not need to be individually claimed. E. PROCESS INFORMATION ' A claim of confidentiality for category , Process Information, automatically includes items in part li, section A, subsection 2. These items do not need to be individually claimed. P. OTHER INFORMATION No items on the form are automatically included in this category. Thus sil claims for this category must specify category F. ' GENERAL CERTIFICATION I hereby certify to the but of my ioiowiedge and belief, that: a. The comoany named in section A, item 1, intends to manufac ture for a commercial ouroose the chemical substance lor wmcn this notice is submitted, other than in small quantities lor research and development, and that the substance is not excluded from premanuiacture notification (40 CFR 720.131; b. All information entered on this Premanufacture Notiea form is complete and truthful as of the date of submittal; and c. I am submitting with this form all lest data in my possession or control concerning effects of the suOstance on health or the environment and a description of any outer data known to or rusonaoly ascertainaoie Oy an, in accordance with 40 CFR 720.23. I also agree to permit access to, and the eooying of records by a duly authorized redresentabve of the EPA Administrator in accord ance with the Toxic Substances Control Act and any regulations issued thereunder, to document any information reoorted in this term. Signature of authorized official Srn/niuJ?i tttmeOQiudtU- /S', CONFIOENTiALm CERTIFICATION I hereoy certify to the truth and accuracy of the following foia statements concerning ail information which if claimed confidential. e. The Information is not publicly available elsewhere; and 4. Disclosure of the information claimed confidential would causa substantial harm to my company's competitive position. a. My comoany has taken measures to protect the confidentiality of the information, and it will continue to take these measixes; b. The information is not. and has not been, reasonably obtain able by other persons (other than governmental bodiul by using legitimate means (other than discovery sued on a snowing of soeciai need in a juoicial or ouasi-)uaiciai proceeding) with out the c omoany' a consent; EPA Fonw 7710 - 25 ( 9-79) Si gnatue of authorized official SrmujJ) {Ux.i\tujf Date, . ' ./ is fi^i 1 I1C6 2r>749 , 59836 Federal Register / Vol. 44. No. 201 / Tuesday. October 16.1979 / Proposed Rules Part 1 - GENERAL INFORMATION > Section A - MANUFACTURER identification The answers to items 1, 2. and 3 will oe included in his claim. It you claim he answers to items 4 or 5 confidential, place the letters) A-F in he box wtticb indicates he oasis of your claim and answer me linkage questions in appendix A, section II. for categories A-E. t Person pMing Notice '** of autnorued official Samuel Hunter. Ormization _' AdsoIusoI Company Title President Confiden tial coda * L*; ; : *--i' |&r" , "Sfostkaf eSass. 01792 Name Sally Murphy, Ph.D. City, State, ZIP code Boston, Mass. 01792. 1. Parent Coaoanv 'Tra Mailing address fNwnoer and street/ City, State, ZIP cooe . Title Project Engineer suv .i , SK's 4. Enter tne intended date of commencement of manufacture for commercial ourposes. If he mteneed date of commencement of manufacture is more hen 3 years after he date of his notice. juomrt evidence of intern tp manufacture in accordance with 40 CFR 720.20(h). |_| Merfr Ifiis Box if you Mttaefi evidence. ------------------------------------------------------------------------------------------------------------- ---- -------- j 5, If you have had a Prenouca Communication (PC) cancarninf this notice and EPA assigned a PC numoer to this notice, enter PC Numoer l >1 Month Year ' .V*\ April 1 * 1980 - - Mr* (X) r"l , 1 ffnone >1 J 1 00 CONTINUE WITH SECTION B ON PAGE 3 . . Federal Register / Vol. 44, No. 201 / Tuesday, October 16.1979 / Proposed Rules 59837 _ . . Port IV - FEDERAL REGISTER NOTICE Information provided in this part will ba published in tho Ftdarol Register in accordance with taction 5(d) (2) of TSCA. Do not enter any information in this port for which you hava assartod a claim of confidentiality. Section A - CHEMICAL IDENTITY Enter the specific chemical name of the substance If it Is not claimed confidential If the chemical Identity W^elairnedv\\ confidential, enter the name agreed to by PA in Prenotice Communication or CPA will enter one of the^mer merle names In part I, section C. , ,. ,, This section would be completed m accordance with the instructions. Section B - MANUFACTURER IDENTIFICATION Enter the legal title of the organization filing this notice If it Is not claimed confidential. If the legal title of the organization Is Claimed confidential, provide a description of the organization in accordance with section III, Appendix A, Instructions for Asserting and Substantiating Claims of Confidentiality. ' The submitter has total annual sales of between $1,000,000 and $9,999,999, and intends to produce the new chemical substance at a plant in the Northeast region of the country whose three digit Standard Industrial Classification code is 307. ^ SiHs0trLctUionsATA ^is section would be completed in accordance with the if. L If use data were not claimed confidential in section 0, list the categories) of use that you reported in section 0, Item 2a. Mark (X) it the use category!ies) is site limited, industrial, commercial, or consiener. Site limited (2) Mark (X) eoorooriere box Industrial Commercial (3) (4) Consumer (5) 2. If use data were claimed confidential, provide a description of the category of useis) of the chemical substance in accordance with section II, Appendix A, Instructions for Asserting and Substantiating Confidentiality. This description should be as specific as possible without revealing confidential information. .''O <<. ' , \ v \_ V> P ^nstruct^iEonsDATA This section would be cocr^ffieced in accordance with the List ail test data concerning health and environmental effects of the manufacture, processing, distribution, in commerce, use, or disposal of the new chemical substance that are being submitted, described, or cited as part of this notice. Provide a brief abstract of ail test data on . the new chemical simstance that are submitted in accordance with 720.23(a) and 720-20(i). If physical-chemical properties are claimed con fidential, provide a generic description of these properties in accordance with section III, Appendix A, Instructions for Asserting and Substantiating Claims of Confidentiality. -- Mer* this box it you arraeft e continuation sheer. 59838 Federal Register / Vol. 44, No. 201 / Taesday, October 18,1979 / Proposed Rules (This information would be provided in an attachment *to- the form.) Confidentialitv Claims Category A Linkage Question ~ A. Manufacturer's (Importer's) Identity ....... *,For every item that you have marked with an "A answer the following question: How would disclosing this item reveal your company's identity? . . Part I, Section A, Question 4: ' "This information in conjunction with the generic ' information provided for the manufacturer's identity and chemical identity would reveal our company name because we are the only company of our size located in the northeast with the capability of manufacturing a new chemical substance of this type within the next six months. When we introduce our new product it will be clear that our company submitted the premanufacture notice." Federal Register / Vol. 44, No. 201 / Tuesday. October 16. 1079 / Proposed Rules Example 2 - Chemical Identity {Part II, Section B) Beeswax Incorporated has filed a PMN, The company is asserting a claim of confidentiality for information in category B, specific chemical identity. As illustrated on the form, a check has been placed in the box to indicate that the company is asserting this claim. The answers to items 1,2, and 3 are automatically included in the claim of confidentiality. In accordance with PA's instructions for claiming confidentiality for specific chemical identity the company has provided three generic name(s) from which EPA will choose a single name for publication in the -FEDERAL REGISTER notice along with other information in Part III of the form. The company is also asserting .a claim of confidentiality for information on impurities provided in response to question 4. Because the answer to question 4 is not automatically linked to the claim of confidentiality for category B, specific chemical identity, Beeswax must place a B* in the box next to question 4, and answer the following linkage question in Appendix A, Instructions for Asserting and Substantiating Claims of Confidentiality: B: Specific Chemical Identity For every item that you have marked with a "B", answer the following question: Bow would disclosing this item reveal the specific chemical identity? The answers to the linkage question and the answer to the substantiation questions for category B, chemical identity, were attached to the form by the company. 59839 59840 Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules fc Section B - CHEMICAL IDENTITY The answers to items 1, 2, and 3 will be included in this claim!' ` If you claim Chemical Identity confidential. Is 'this claim limited to the period prior to manufactive? t gy Yes 11 I No If you claim the answer to item 4 confidential, place the letters) A-F in the box which indicates the basis of your claim and answer the linkage questions in appendix A, section It, for categories A-E. Complete either 1, 2, or 3 as appropriate. Complete 4. O, yk% `"Kres-r""' Substance (other than polymers) ' b. Specific chemical name . (^H\V\yW N-(4-bromophenyl) acetamide v/ c.Jloiecuiar formula CaH80NBr d.Synonyms 4-bromo acetanilide, p-bromo acetanilide e. Trademarks N/A f. Structural diagram HO 0 1 li N-C-CHo 2. Class 2 . Chemical Substance LJiUark this box If you attach a continuation sheet. ** Re>',(ry No- known) b. Specific chemical name c. Synonyms d. Trademarks a. List the immediate precursor substance*s| and reactants with their respective CAS Registry Humberts) and describe the nature of the reaction. Also provide a partial or incomplete chemical structure diagram (where appropriate). Indicate the range of composition. Confiden tial code >. ^ r; n-v ^ae*>rW-x-K- >' jfc ' g> 1& '* :K ' . (ZD Mark this box If you attach a continuation sheet. Federal Register / Vol. 44. No. 201 / Tuesday, October 18. 1979 / Proposed Rules 59641 S. Polymers a. (1] Provide the specific chemical names and the CAS Registry Nunbar of those monomers and other reactants used in the manufacture of the polymer. (2) Mark (X) the identity column if you wish monomers used at two percent (by weight) or less to be listed as part of the polymer description on the inventory. (3) Provide the intended range of composition of the polymer in terms of monomer percent (by weight). If your notice is for any copolymer of the listed monomers, enter "any" under Range of Composition. (4) For each monomer, indicate the maximum amount (weight percent) that may be present as a residual in the polymer as distributed in commerce. ' Monomers and CAS Registry No. (1) Identity Mark (X/ (2) Range of composition (3) Maximum amount (weight percent) (4) Confiden tial code (5) * % ft __ . b. Indicate the minimum average molecular weight or the minimum degree of polymerization of the polymeric compositions to which this notice applies. . 4. Impurities (a) List each impurity, including CAS Registry Number, which may reasonably be anticipated to be present in the chemical substance as it wilt be manufactured for commercial purposes, (b) Estimate the maximum percent (by weight] of each impurity. Base your answer on information developed during R & D activities, your knowledge of manufacturing process chemistry and anticipated quality control operations, (e) Mark (X) if the concentration of an impurity will be specifically controlled because of your concern about potential adverse health or environmental effects, (d) Estimate the maximum total percent (by weight] of the impurities that may be present Impurity and CAS Registry number <a> 2,4-dibromo acetanilide (23373-04-8) N.N-dlacetylaniline (NA) acetanilide (103-84-4) Maximum percent present (b) 5 * .01 * .1 Mark If to be specifically - controlled (C) Confiden tial code B B B % ^ * .* - ft % Mark this box It you attach a continuation sheet. 4.Total percent ................... P 7 ft- Section C - GENERIC NAMES Complete this section only if Specific Chemical Identity is claimed confidential. For instructions on how to develop generic names, see appendix II, 40 CFR 720 (44 FR 227S1, Proposed _______________Premanufacture Notification Requirements ana Review Procedures.__________ _____ _________ - renericname agreed on by Prenotice Communication gewric*names. 4-subst1tuted acetanilide 4-substituted bromobenzene " N- (bromo carbomonocycle) acetamide 59842 Federal Register / Vol. 44, No. 201 / Tuesday. October 16,1979 /. Proposed Rules Confidentiality Claims Category B 1. Linkage Question for Question 4 of Part I, Section B: Disclosure of the information that one of the impurities is 2,4-dibromo acetanilide in conjunction with the generic name-"4-substituted acetanilide" clearly reveals that the masked substituent in the generic name is bromine. In addition disclosure of the information that N,N- diacetylaniline and acetanilide are minor impurities in conjunction with generic names 2 or 3 reveals that the masked portion of the molecular structure is an acetamide derivative. Therefore/ the information in question 4 plus the generic names would disclose the specific chemical identity which we claim is confidential business information. , 2. Substantiation for All Claims in Category B: (Beeswax Incorporated's answers to the substantiation questions would begin here.) * Federal Register / Vol. 44. No. 201 / Tuesday, October 18, 1979 / Proposed Rules Example 3 - Health and Safety Study (Attachment) This example illustrates how a submitter would assert a claim of confidentiality for information in a health and safety study. Examples of substantiation for this information are not provided. Pinnacle Chemical Company filed a PMN and submitted a health and safety study as an attachment to the PMN form. It claimed confidentiality for information in the health and safety study under Category A, Manufacturer's Identity, and Category B, Specific Chemical Identity. Pinnacle identified these confidential items in the health and safety study by circling them where they appear in the study and by writing the appropriate category letter (A or B, in this case) in the margin next to the circled information. (In addition to the claims illustrated in this example. Pinnacle made the claims on the PMN form itself in accordance with EPA's reporting instructions. The company also adhered to the guidelines for developing a generic manufacturer's identity and three generic chemical names in Part III of the form, for publication in the Section 5(d)(2) FEDERAL REGISTER notice). Pinnacle answered the linkage questions for Categories A & B that are found in Appendix A, Instructions for Asserting and Substantiating Claims of Confidentiality. The company also submitted an explanation establishing that its identity is unrelated to the health and safety effects of the substance, as explained in Section II C of the Instructions. 59843 59844 Federal Register / Vol. 44, No. 201 / Tuesday, October 16.1979 / Proposed Rules SAMPLE (Submitter's Attachment to the Form) Confidentiality ClaimCategory A Linkage Question for Items in Our Health and Safety Studyr How would disclosing this item reveal your company's identity? Answer: These items are our company's identity. [NOTE: If other items on the form or in the attachment are claimed confidential and linked' to Category A, Manufacturer's Identity, the answers to the linkage questions for each item claimed in Category A would be included in this attachment.] SAMPLE Our company's identity is totally irrelevant to the health and safety effects of this substance. It is not necessary to know the name of our company to interpret and assess this health and safety study. Knowledge of our company's identity would not provide any information regarding the appropriateness, the validity, the methodology or the accuracy of this study. Thus keeping our identity confidential will have no bearing on using the attached study to assess the risks that this chemical may or may not present to health and the environment. . Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules SAMPLE 59845 Linkage Question for Items in Our Health and Safety Study; How would disclosing this item reveal the specific chemical identity? Answer: CH2F CH2OCH2H2E is the molecular formula of the substance and is equivalent to specific chemical identity. Explanation: Chlorsake is the common name of this chemical and has been manufactured previously. It has been referenced in the chemical literature and the name Chlorsake is tied to the molecular structure in this literature. Therefore any competitor who would see Chlorsake appearing in conjunction with the generic names we have submitted, and who knows that Chlorsake is being used with reference to a new chemical substance, would have enough information to know the specific chemical identity. [NOTE: If other items on the form or in the attachments are claimed confidential and linked to Category B, Specific Chemical Identity, the answers to the linkage questions for each item claimed in category B would be included in this attachment.] 59846 Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules NOTE: (The tradename, molecular formula, and test results used in this example are for illustrative purposes only and do not reflect actual test results. Only the executive summary has been included in this example. The company would have submitted the entire report). -HEALTH AND SAFETY STUDY EXECUTIVE SUMMARY I\ 0 CONFIDENTIAL SAMPLE 1. Identity: [B] Chemical Substance: 2. Summary of Adverse Effects and Possible Risks: [B] Previous testing has shown that ^Chlorsakej^ was not mutagenic to bacteria in the Ames test. In teratogenicity studies involving rats, the compound is fetotoxic at exposure levels cf 500 ppm., but no effects were seen at exposure levels of 50 ppm. Federal Register / Vol. 44. No. 201 / Tuesday, October 16.1979 / Proposed Rules The following effects have been noted dominant lethal studies using mice. T were designed to look for possible sp male animals. In the first study, two groups oS. male mice were exposed in inhalation chambers for six hours per day to levels of 100 and 1000'ppm for five days and a third group was exposed to 2000 ppm for two days followed by 500 ppm for three days (necessary because of the toxic effects of 2000 ppm on the mice). Each of the mice was mated weekly with two virgin females for eight-nine weeks to cover all stages of spermatogenesis. The number of sucessful fertilizations was reduced at the 1000 and 2000 ppm levels, but unaffected the 100 ppm level when compared with an unexposed control group. It was not possible to determine whether the reduction in fertilizations was due to reduced food intake, to loss of libido, or to a true sperm effect. The second study, while not statistically analyzed, has confirmed the reduced fertility observed in the first study and demonstrated a true sperm effect. The reduced fertility occured in both exposed groups (1000 and 250 ppm) and was accompanied by high cumulative mortality (34% and 27% at the high and low dosages respectively), reduced testicular 59847 i 59848 Federal Register / Vol. 44. No. 201 / Tuesday, October 18, 1979 / Proposed Rules weight, a low sperm count, and a si the percentage of abnormal sperm. examination of the testes revealed i effects on the germinal epithelium in which mossC damage occured by weeks two, three and four with recovery of tubules and spermatogenesis from week five onwards. [B] The present commercial an intermediate ingredient. In contrast to the levels of exposure in the above animal tests, our facility are less than four ppm and average less than two ppm personal exposure. We therefore do not believe, on the evidence that we have, that there will be an effect on the employees from the very low exposure levels found in the workplace. Submitted by: [A] Sincerely yours, [A] Federal Register / Vol. 44, No. 201 / Tuesday, October 18.1979 / Proposed Rules APPENDIX C 59849 Attached are two sample block diagrams (A, manufacturing operation? B, processing operation) that illustrate the type of response that should be provided in completing Part II, Section A, Subsection 2, of the Premanufacture Notice Form for domestic manufacturers. The level of detail of an individual submitter's response may vary depending upon the extent to which the information is "known to or reasonably ascertainable." 59850 Federal Register / Vol. 44, No. 201 / Tuesday, October 16.1979 / Proposed Rules iKlCSSMt A jsocsss rsroRMAXiow TSTSAaOTSLTn 3ATC3 PSODCCTION SUM MATZ3ZA1S phoczssss ?aocpcrs 3EL2ASS POINTS Mo Monti CC Claaning Operation 3SACTTCM: 4(<33C32Ca,C22J 3Ai * ISnCi, " is purged vita water ween cleaaed. Tie vastawatar la than discharged ta sever. The reaction tanJc. cantriiuga, and distillation column ara purged vith nethylene, chloride, or other suitable solvent depending upon product to be aaaudacrured. These vestas are distillad ta recover solvent and product. The bottoms are dressed and sent. ;a-a landdiii. <=4C12 4NaCl----------4-MaAlCl4 * 3 !C2:CH^CS2C22; _jSn , **SIIE RSACTION: |(CS3C22CH2C32)3-U - SnCi.!.i - 1.2.3) fcj A1C13 - (C23CH2CS2CZ-);i3nCi 4 -A Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules Attachment: B PROCESS INFORMATION BATCH DYEING PROCESS USING NUMBER 3 GREEN DYE RAW MATERIALS PROCESSES & PRODUCTS RELEASE POINTS 59851 3t = 3atch Ct = Cleaning Operation when different fairies and dyes are used. Ths caustic wastewater is discharged to sewer. 59852 Federal Register / Vol. 44, No. 201 / Tuesday. October 18, 1979 / Proposed Rules PROPOSED v>EPA United States Environmental Protection Agency PREMANUFACTURE NOTICE IMPORTERS FORM Whan completed sand this form to: Document Control Officer Office of Toxic Substances, T1-7SJ U.S.E.P.A. 401 M Street, S.W. Washington, D.C. 20460 EPA USE ONLY Date of receipt GENERAL INFORMATION The Premanufacture Notice form tor importers is divided into the following parts: Part I - General Information Part II - Human Exposure and Environmental Release Part III - List of Attachments Part IV - Federal Register Notice Part V - Optional Data The optional part (part VI is not included in this package. All data requested in the mandatory parts (parts I, II, III, and IV) must be reported to the extent they are known to or reasonably ascertainable by the submitter. This means that the submitter is expected to answer all questions to the best of his/her ability, including making reasonable estimates in cases where complete factual information is not available. If the submitter is unable to make a reasonable estimate (i.e.. the data is not known and is not reasonably ascertainable), he/she should enter "NA" (not available). In part I, the submitter is required to report the specific chemical identity of the new substance, regardless of whether the informa tion is claimed as confidential. In accordance with proposed 5720.20(f), the submitter may authorize another person to report the specific chemical identity in his/her behalf. The notice will not be valid until the specific chemical identity is received by EPA. It the space on the form is not sufficient to adequately answer a question, the submitter may attach additional sheets. Identify any continuation by part, section, subsection, and item. ASSERTING AND SUBSTANTIATING CLAIMS OF CONFIDENTIALITY Read Appendix A. Instructions for Asserting and Substantiating Claims of Confidentiality, for information on how to claim ana substantiate confidential business information included in this form or in attachments to the form. Claims of confidentiality must be made in accordance with sections I and II of these instruc tions. In addition, substantiation of all claims of confidentiality must be made in accordance with section IV of these instructions. If you claim any item in any attachment to this form confidential, see SPECIAL INSTRUCTIONS for attachments. Appendix A, Section II. Appendix B "Examples," provides additional guidance for asserting and substantiating claims of confidentiality. In accordance with sections I and II of the confidentiality instruc tions, claims of confidentiality must be made by using the follow ing six categories: A. IMPORTER S IDENTITY - A claim of confidentiality for category A. Importer's identity, automatically includes items 1 and 2 in part 1, section A. B. SPECIFIC CHEMICAL IDENTITY A claim of confidentiality for category B, Specific Chemical Identity, automatically includes items 1, 2, and 3 In part I, section 8. C. IMPORT VOLUME - A claim of confidentiality for category C. Import Volume auto matically includes item I in part I. section D. These items do not need to be individually claimed. D. USE DATA ^ A claim of confidentiality for category D, Use Data, automati cally includes item 2 in part I, section D. These- items do not need to be individually claimed. E. PROCESS INFORMATION A claim of confidentiality for category E, Process Information, automatically includes items in part It. section A, subsection 2. These items do not need to be individually claimed. F. OTHER INFORMATION No items on the form are automatically included in this category. Thus ell claims for this category must specify category F. GENERAL CERTIFICATION I hereby certify to the best of my knowledge and belief, that: a. The company named in section A, item 1, intends to import for a commercial purpose the chemical substance for which this notice is submitted, other than in small quantities for research and development, and that the substance is not excluded from premanufacture notification (40 CFR 720.13); b. All information entered on this Premanufacture Notice form is complete and truthful as of the date of submittal; and c. I am submitting with this form all test data in my possession or control concerning effects of the substance on health or the environment and a description of any other data known to or reasonably ascertainable by me, in accordance with 40 CFR 720.23. I also agree to permit access to, end the copying of records by a duly authorized representative of the EPA Administrator in accord ance with the Toxic Substances Control Act and any regulations issued thereunder, to document any information reported in this form. Signature of authorized official Date CONFIDENTIALITY CERTIFICATION I hereby certify to the truth and accuracy of the following four statements concerning all information which is claimed confidential. c. The information is not publicly available elsewhere; and d. Disclosure of the information claimed confidential would cause substantial harm to my company's competitive position. a. My company has taken measures to protect the confidentiality of the information, and it will continue to take these measures; b. The information is not, and has not been, reasonably obtain able by other persons (other than governmental bodies! by using legitimate means (other than discovery based on a showing of special need in a judicial or quasi-judicial proceeding) with out the company's consent: Signature of authorized official Date Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules 59853 Part 1 - GENERAL INFORMATION t Section A - IMPORTER IDENTIFICATION If you claim importer's identity confidential, mark (X) the box at the right--........... The answers to items 1 and 2 wiirbe included in this claim. 1 1 If you claim the answers to items 3, 4, 5, or 6 confidential, place the letter(s) A-F in the box which indicates the basis of your claim and answer the linkage questions in appendix A, section II, for categories A-E. 1 Person Filing Notice Name of authorized official Organization Title ~ Confiden tial code Mailing address (Number and street) '+ City, State, ZIP code 2. Technical Contact Name Mailing address (Number and street) ' Title ' iv IS 'X'ss :;..v City, State, ZIP code 3. Enter the intended date of commencement of import for commercial purposes. If the intended date of commencement of import is more than 3 years after the date of this notice, submit evidence of intent to import in __ accordance with 40 CFR 720.20(h). 1 1 Mark this box it you attach evidence. 4- Port of entry - Enter name----------------- 1 5. If you have had a Prenotice Communication (PC) concerning this notice I and EPA assigned a PC number to this notice, enter PC Number----------------- J 6. Do you intend to manufacture, or contract for the manufacture of the new chemical substance in the United States within 3 years of the intended date of import? i Q Yes j Area code j Number Telephone 1 1 Month Year J ' v\ s z Q No Mark (X) j--i It none > 1 1 3Q Don't know CONTINUE WITH SECTION B ON PAGE 3 Page 2 59854 Federal Register / Vol. 44, No. 201 / Tuesday, October 16.1979 / Proposed Rules Section B - CHEMICAL IDENTITY If you claim Chemical Identity confidential, mark (X) the box at the right. The answers to items 1. 2, and 3 will be included in this claim. If you claim Chemical Identity confidential, is this claim limited to the period prior to manufacture? <LJYes __ J LJ No If you claim the answer to item 4 confidential, place the letters) A-F In the box which indicates the basis of your claim and answer the linkage Questions in appendix A, section II, for categories A-E. - 1 1 Complete either 1, 2, or 3 as appropriate. Complete 4. Mark (X) the box at the right if the-chemical identity will be reported by the foreign manufacturer or supplier.----------------------------------------- (_J 1. Class 1 Chemical Substance (other than polymers) a. CAS Registry No. (if known) b. Specific chemical name c. Molecular formula d. Synonyms ' e. Trademarks Confiden tial code f. Structural diagram ifeC S-f t ' " sr"* * ' 2.Class 2 ' Chemical Substance 1 1 Mark this box it you attach a continuation sheet. a. CAS Registry No. (if known) b. Specific chemical name C. Synonyms d. Trademarks . a. List the immediate precursor substance(s) and reactants with their respective CAS Registry Numbers) and describe the nature of the reaction. Also provide a partial or incomplete chemical structure diagram (where appropriate). Indicate the range of composition. ^' Liver* this box It you attach a continuation sheet. Pace 3 Federal Register / Vol. 44. No. 201 / Tuesday. October 16,1979 / Proposed Rules 59855 3. Polymers a. (1) Provide the specific chemical names and the CAS Registry Number of those monomers and other reactants used In the manufacture of the polymer. (2) Mark (X) the identity column if you wish monomers used at two percent (by weitfit) or less to be listed as part of the polymer description on the inventory. (3) Provide the intended range of composition of the polymer in terms of monomer percent (by weight). If your notice is for any copolymer of the listed monomer, enter "any" under Range of Composition. (4| For each monomer, Indicate the maximum amount (weight percent) that may be present as a residual in the polymer as distributed in commerce. Monomers and CAS Registry No. ______ (1) Identity Mark (X) (2) Range of composition (3) Maximum amoixit (weight percent) )____ Confiden tial code 15) b. Indicate the minimum average molecular weight or the minimum degree of polymerization of the polymeric compositions to which this notice applies. I~1Mark this box if you attach a continuation sheet. 4. Impurities (a) List each impurity, including CAS Registry Number, which may reasonably be anticipated to be present in the chemical substance as it will be imported for commercial purposes, (b) Estimate the maximum percent (by weight) of each impurity. Base your answer on information developed during R & D activities, your knowledge of manufacturing process chemistry and anticipated quality control operations, (c) Mark (X) if the concentration of an impurity will be specifically controlled because of your concern about potential adverse health or environmental effects, (d) Estimate the maximum total percent (by weight) of the impurities that may be present. Impurity and CAS Registry number (a) Maximum percent present (b) Mark It to be specifically controlled (c) Confiden tial code % % * %. % % % * % U Mark this box It you attach a continuation sheet. % Section C - GENERIC NAMES Complete this section only if Specific Chemical'Mentity is claimed confidential. For instructions on how to develop generic names, see appendix II, 40 CFR 720 (44 FR 2278), Proposed ______________ Premanufacture Notification Requirements and Review Procedures._____________________________________ 1. Enter the generic name agreed on by EPA in Prenotice Communication or provide 3 generic names. Page 4 59856 Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules >. Section D - U.s. IMPORT AND MARKETING DATA If you claim Import Volume confidential, merit (X) the box at the right ----------------------------The answers to item 1 will he included in this claim. 1. Estimate the minimum and maximum annual import volume for the first three years of import. Include In your estimates import by others with whom you have contracted to import the new chemical substance. Import year <1) Minimum (2) Import (Kg/yr) ' Maximum (3) Confiden tial cede a. First year b. Second year c. Third year 2. Category of use .. If you claim Use Data confidential, mark (X) the box at the right----------------------------------------------------- 1 1 The answers to item 2 will be included in the claim. a. List the categories) of use on which you have based your import estimates. (Example: solvent used in automotive painU List partial information if complete information is not known. (Example: solvent.l Mark (X) the categories of use as industrial, commercial, or consumer. Estimate the percent of total import volume for the first 3 years devoted to each category of use. Category of use (1) Percentage of import volume (2) Mark. (X) appropriate columnist Industrial ` (3) , Commercial W Consumer <51 Confiden tial code - * | | Mart this bo* It you attach a continuation sheet. fc. List any ether categories) of use that you have actively explored * Mart this bo* It you attach a continuation sheet. *. Do you intend or expect the new chemical substance to be used to treat drinking water supplies or to be used in products (e.g., paints or coatings! that will come in contact with drinking water? t0Yes 2 0 No S0 Don't know MOTE - if you claim the answers to items 3 or 5 confidential, place the tetterfs) A-F in the box which indicates the basis of your claim and answer the linkage questions in appendix A,section II for categories A-E. If you claim any item submitted in an attachment confidential, see SPECIAL INSTRUCTIONS, appendix A, section II, part B. S. Has the chemical substance been manufactured before? t 0 Yes a 0 No s 0 Don't know 4. Herart warnmgs Attach to this notice a copy or reasonable facsimile of any hazard warning statement, label, labeling, marking or instructions, technical data sheet, material safety data sheet, and any other information which will be provided to any person regarding the safe handling, transport, use, disposal, treatment upon accidental exposure, or the formulation, construction, or labeling of products containing the . chemical substance. Mark this box It you attach a hazarxj warning. S.Enter the number of eustomers who have either contracted to pwchase, submitted a purchase order, or made any other firm commitment to purchase the new chemical substance from you for a category of use unknown to you. Estimate the percentage of yoir import volume that will be purchased by such customers during the first 3 years of import. Pages Number of customers Percentage import volume Confiden tial code % Federal Register / Vol. 44, No. 201 / Tuesday, October 16. 1979 / Proposed Rules 59857 Section E - TRANSPORT If you claim the answers to items 1 or 2 confidential, place the letters) (A-F) in the box which indicates the basis of your claim and answer the linkage questions in appendix A, section II for categories A-E. 1. Enter the proper DOT shipping name and hazard class of the new chemical substance (if applicable!. a. Shipping name Confiden tial code b. Hazard class 2. Mark (X) the models) of transport which you believe will be used for the new chemical substance to enter the U.S. and within the U.S.* 1 a. To enter the United States 1 Q Truck 2 0 Railcar a Q Barge, vessel a | | Pipeline s 0 Plane s 0 Other -- Specify b. Within the United States 11 | Truck 31 | Barge, vessel 21 | Railcar | | Pipeline Section F - RISK ASSESSMENT sQ Plane 61 | Other -- Specify If you claim any item submitted in an attachment confidential, see SPECIAL INSTRUCTIONS, appendix A, section II, part B. if you have evaluated the health or environmental risks which may be presented by the manufacture, processing distribution in commerce, use, or disposal of the new chemical substance attach your evaluation. f~l Mark this box it you attach a risk assessment. Section G - DETECTION METHODS If you claim the answers to item 1 confidential, place the letter(s) A-F in the box which indicates the basis of your claim and answer the linkage questions in appendix A, section II, for categories A-E. 1. Is an analytical method available to identify and quantify the presence of the new chemical substance - Identify Quantify a. In workplace air? e. In workplace air? 10 Yes 2 0 No *0 Don't know 10 Yes 2 0 No 10 Don't know Confiden tial code b. In effluent streams? i 0 Yes 2 0 No s 0 Don't know f. In effluent streams? 1 0 Yes 2 0 No 10 Don't know c. In materials requiring disposal? t 0 Yes 2 0 No d. In end products for which the new substance is an intermediate? < 0 Yes 2 0 No s 0 Don't know 10 Don't know g. In materials requiring disposal? 10 Yes - 2 0 No 10 Don't know , h. In end products for which the new substance is an intermediate? i 0 Yes 2 0 No 10 Don't know Page 6 - * >j -' 59858 Federal Register / Vol. 44. No. 201 / Tuesday. October 16, 1979 / Proposed Rules Port II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE Section A - U.S. INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER If you claim Process Information confidential, mark (X) the bos at the right. The answer to subsection 2 will be included in this claim. If you claim the answers to items in subsections 1. 3, or 4 confidential, enter the letterfsl A-F in the box which indicates the basis of your claim and answer the linkage questions in appendix A, section II, for categories A--E. If you claim the answers to items 3.3, 4.3, or 4.4 in subsections 3 or 4, or any items submitted in an attachment confidential, see SPECIAL INSTRUCTIONS, appendix A, section II, part B. Complete a separate subsection 1 and subsection 2 sheet for each site where you will process or use the new chemical substance. - Subsection l - PROCESS INFORMATION Confiden tial code 1.1 Identity Name of site Physical location address (Number ana street) City, County, State, ZIP code 1.2 Type of site i| j Processing aQUse 31 | Continuous |~~1 Batch 1J Hours of operation Days per year Hours per day 1.4 Amount processed or used--------------- Minimum Kg/yr. Maximum Kg/yr. Subsection 2 - BLOCK DIAGRAM 2.1 Provide a block diagram identifying the major uml operations and chemical conversions. Also include: a. For each chemical conversion in the block diagram identify the major chemical reactions and the major side reactions. b. Provide the approximate mass of all feed materials, byproduct materials, and products which are entering and leaving each major unit operation and chemical conversion. Indicate the method of transfer of these materials and whether the operation is open or closed to the workplace environment. c. Identify those points in the block diagram from which there will be releases ol the new chemiffal substance or byproduct materials into the air, land, or water environment. O Uar* this box It you attach a continuation sheet. Page I Federal Register / VoL 44. No. 201 / Tuesday, October 16,1979 / Proposed Rules 59859 Subsection 3 - OCCUPATIONAL EXPOSURE Complete a separate subsection 3 for each site at which you will process, use, or dispose of the new chemical substance. Indicate the anticipated route(s) of exposure to the new chemical substance (e.g., inhalation, ingestion, dermal), the number of employees anticipated to be exposed by each route, and the maximum duration of such exposure, (in days per year and hours per day). In the table below, mark (X) A-Average or P-Peak for the concentration levels that are expected to be present in the immediate vicinity of the process equipment. Base your answer on maximum annual processing, or use during the first 3 years of import under normal operating conditions with all engineering safeguards in place. Confiden tial code 3J Identity of site Name Physical location address (Number end afreet) City, County, State, ZIP code 32 Occupational Exposure at Industrial Site Concentration Activity (1) a. Processing b. Use c. Disposal Exposure route(s) (2) Maximum number exposed (3) Maximum duration <) Nr./day jOays/yr. 1 1 1 1 1 1 t 1 1 -- , 1 . Unit of neasure t ppm aQmg/m* i ppm a mg/m3 t ppm * mg/m3 (5) Mar* (X) appropriate column A - Average P - Peak 0-1 1-10 10-100 >100 A PA P A P AP 34 Describe those operations in which workers will be directly exposed to the new chemical substance. f itfhi'vi ' ' -- D Mar* this tax II you attach a continuation sheet. 3.4 Mark (X) as many of the physical states of the chemical substance to which workers may be exposed in the workplace. ' Solid s Aerosol sQMist 7 0 Dust 9 Other - Specify^ 2 Gas Powder 6 Fume el I Liquid _______ Page 8 Confiden* tial code 59860 Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules ^Subsection 4 - ENVIRONMENTAL RELEASE AND DISPOSAL Complete a separate subsection 4 for each site where you intend to process, use or dispose of the new chemical substance. 4.1 Identity of site Name Physical location address (Number end street) City, County, State, ZIP code Confiden tial code hf Nr* 4.2 Indicate the duration of release into the air and water environment and the annual amount of new chemical substance released to the air, water, and land. Mark (X) the disposition of the water discharge and estimate the effluent flow rate from the site. Enter the name of the POTW or receiving water body. Base your answer on maximum annual production during the first 3 years of manufacture under normal operating conditions. . a. Air Media (1) Duration of release Hrs./day (2) Days/yr. (31 Amount of new chemical substance released tKg/yr.) Less than 10 (4) 10-100 (5) 100 1000 (6) 1000 10,000 (7) More than 10,000 J (8) b. Land , ^' c. Water 11 1 POTW (Publicly Owned Treatment Works) 2 J7j Navigable waterway [71 Other ^ r ^n,er narn^ J 1 4. Effluent stream flow rate------------------------------------ J - Gallons per day 4.3 For each release point indicated in the block diagram, characterize the composition of the release materials. Mark this box II you aftech a continuation sheet. 4,4 Describe pollution control equipment and disposal operations (e.g., scrubber, baghouse, landfill, incinerator, activated sludge, carbon absorption, etc.) used to treat individual or combined releases indicated in the block diagranys) of processing and use operations. I~1 Mark this box II you attach a continuation sheet. Page 9 Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules 59861 Section B - U.S. INDUSTRIAL SITES CONTROLLED BY OTHERS Complete this section using your own forecasts, any information already obtained from other persons who may process, use, or dispose of, the new chemical substance or any other information that is reasonably ascertainable. Complete a separate subsection 1 and subsection 2 for each site where you expect other persons to process, use. or dispose of the new chemical substance. If you claim the answers to the items in subsections 1, 3, or 4 confidential, enter the letters) A--F in the box which indicates the basis of your claim and answer the linkage questions in appendix A, section II, for categories A-E. 1 If you claim the answers to items in subsection 2. or item 3.3 in subsection 3 confidential, see SPECIAL INSTRUCTIONS in appendix A, section II, part B. Subsection 1 - PROCESS INFORMATION 1.1 Identity of site (Optional) Name Physical location address (Number and streetI Confiden tial code City, State, ZIP code County ^ Subsection 2 - PROCESS DESCRIPTION Briefly describe processing or use operations conducted by others. Hark this box If you attach a continuation sheet. Pace 10 59862 Federal Register / Vol. 44. No. 201 / Tuesday, October 16. 1979 / Proposed Rules Subsection 3 - OCCUPATIONAL EXPOSURE Complete a separate subsection 3 for each industrial site where you expect other persons to process, use. or dispose of the new chemical substance. Indicate the anticipated routes of exposure to the substance ie.g., inhalation, ingestion, dermal), the number of employees anticipated to be exposed by each route, and the maximum duration of such exposure (in days per year and hours per day). In the table below, mark (X) A-Average or P-Peak for the concentration levels that are expected to be present in the immediate vicinity of the process equipment. Base your answer on the maximum amount anticipated to be processed, used, or disposed of during the first 3 years of operation under normal conditions with all engineering safeguards in place. Confiden tial code 3.1 Identity of site (optional) Name Physical location address (NunOer ana street) City, State. ZIP code County U Occupational Exposure at Industrial Site ,,Y- t- Activity - Exposure route(s) (11 a. Processing (2) b. Use c. Disposal Concentration Maximum number exposed Maximum duration (4) Unit of measure (5) Mark (X) appropriate column A - Average P - Peak 0-1 1--10 10-100 > 100 (3) Hrs./day [Days/yr. A P AP A P A P 1 1 1 ppm r 2 mg/m3 i i 1 ppm i 2 mg/m* i i i i t ppm 2Qmg/m* I^ N % 3.3 Describe those activities in which workers will be directly exposed to the new chemical substance. Mark this box il you attach a continuation sheet. 3.4 Mark (X) as many of the physical states of the new chemical substance to which workers may be exposed in the workplace, f Solid s Aerosol a Mist 7 Dust a Other - Spec/f)^ a Gas Powder Fume Liquid _____________________ ' Page 11 Confiden tial code Federal Register / Vol. 44, No. 201 / Tuesday. October 16, 1979 / Proposed Rules59863 > Subjection 4 - ENVIRONMENTAL RELEASE AND DISPOSAL Complete a separate subsection 4 for each site where other persons intend to process, use, or dispose of the new chemical substance. 4.1 Identity of Site (Optional) Name Physical location address (Alumber and street) City, State, ZIP code County Confiden tial code *E^T _ ...A--. r 4.2 Indicate the duration of release into the air and water-environment and the annual amount of new chemical substance released to the air. water, and land. Mark (X) the disposition of the water discharge and estimate the effluent flow rate from the site. Enter the name of the POTW or receiving water body. Base your answer on maximum annual production during the first 3 years of manufacture under normal operating conditions. a. Air Media (1) Duration of release Amount of new chemical substance released (Kg/yr.) ' Hrs./day (2) Days/yr. Less than 10 (3) (4) 10 100 (5) 100 1000 (6) 1000 10,000 (7) More than ISS-XT' 10,000 jjgi,>:.: (8) b. Land f; ' . c. Water 1 POTW (Publicly Owned Treatment Works) 2 Navigable waterway 3 Q Other > Enter name. * d. Effluent stream flow rate - -+ l Gallons per day 4.3 |1) List any byproduct materials containing the new chemical substance that are generated during processing and use operations and which are disposed of (e.g., landfill, incineration, or other physical/chemical treatment). Water effluent and air emission streams should not be listed here. Estimates of release of the new chemical substance contained in such streams are required to be reported in item 4.2. (2) Indicate the method of disposal. (3) Estimate the amount of each material generated (Kg.Kg of the new chemical substance), and (4) estimate the percent (by weight) of the new chemical substance. V Material requiring disposal (1) Anticipated method of disposal (2) Amount (Kg/Kg) (3) Percent of new chemical substance (4) Confiden tial code Uark this box II you attach a continuation sheet. Page 12 59864 Federal Register j Vol. 44, No. 201 / Tuesday, October 16.1979 / Proposed Rule* fc Section C - U.S. CONSUMER AND COMMERCIAL USER EXPOSURE Complete this section for ell consumer and commercial categories of use which involve use of a product that intentionally contains the new chemical substance. Provide the information based on your own forecasts, information already obtained from other persons, or any other information that is reasonably ascertainable. If you claim the answers to item 1 confidential, enter letter(s) A-F in the box which indicates the basis of your claim and answer the linkage questions in appendix A, section II, for categories A-E. If you claim the answers to items 2, 3, or 4 confidential, see SPECIAL INSTRUCTIONS, appendix A, section II, part B. 1. Complete the table below. For each consumer and commercial use category reported in section D, item 2, mark (X) If the product will be manufactured by the submitter or by other persons. Indicate the maximum number of consumers or commercial users expected to be exposed, the expected routes of human exposure and the frequency of exposure. Category of use from part II, section 0 11) Use category (2) Manufactured by - (3) Consumer Commercial Submitter Other Exposure routefs) (4> Maximum number exposed (5) Frequency of exposure (6) Oaily Weekly Monthly Yearly Confide ntial code 2. Attach any estimates that have been developed of potential exposure levels for each category of use. n War* this box il you attach any estimates. 3. For each product containing the new chemical substance, explain any aspect of its construction or formulation which you believe will limit the potential for exposure to the new chemical substance. For mixtures, indicate the maximum percent by weight of the chemical substance in the product. f~l Uark this box it you attach a continuation sheet. 4. Identify any byproducts which are formed as a result of each category of use described in this section. D Mark this ho* H you attach a continuation sheet. Page 13 Federal Register / Vol. 44, No. 201 / Tuesday. October 16.1979 / Proposed Rules 5966? Port III - LIST OF ATTACHMENTS Under section 5t'd)(ll(B) and (C) of TSCA and 40 CFR 720.23, an importer must submit all test data in his her possession and control, and a description of any other data that ate known to or reasonably ascertainable by him/her concerning the effect of manufacture, processing, distribution in commerce, use, or disposal of the new chemical substance on health or the environment. The regulations specify which data must be submitted with the notice and which data may be referenced by literature citations. Using the categories provided, identify (1) attachments containing test data, descriptions of data, or literature citations in accordance with 720.23; (2) other attachments required to be submitted with this notice; (3) confidentiality substantiations and (4) attachments which contain information voluntarily submitted. All attachments should be clearly identified and numbered. - To assert and substantiate a claim of confidentiality for any information included in the following attachments, follow the instructions in Appendix A, section II, part B. Note - Special directions for test data or other "Health and Safety" studies included in section III, part C. The instructions provide that you must also submit a "sanitized" copy of the attachment with all information that you are claiming confidential deleted. EPA will place this copy in the public docket. a. Physical and chemical properties data Attachment name ----------------------------------------------------------------------------------------------------------- ` ' j i l | J , i 1 1 1 '' ' "............ "1 ! b. Health and i environmental l effects data ---------------------------------------------------------------------------------------------------------------------------------------- ] Attachment number - 1 1 1 1 * C` attachments d. Confidentialitv attachments Psrt ii J Seetion/Subsection J Item 1 1 j '1 '1 !I >!i '! 1*11 `1' i1 `'1 11 1 'I i 1-------------------------------------------- ^------------------------------------------ii 1 i! j :i 11; e. Voluntary attachments i,---------------------------------------------i |--------------------------------------------! -------------------------------------------- l1 ! !i ii 1 ! 1 1 ! Mark this box it you attach a continuation sheet. Page 14 59866 Federal Register / VoL 44, No. 201 / Tuesday, October 16.1979 / Proposed Rule* Port IV - FEDERAL REGISTER NOTICE Information provided in this part will be published in the Federal Register in accordance with section 5(d)(2) el TSCA. Da not enter any information in this part for which you have asserted a claim of confidentiality. Section A - CHEMICAL IDENTITY Enter the specific chemical name of the substance if it is not claimed confidential. If the chemical identity Is claimed confidential, enter the name agreed to by EPA in Prenotice Communication or EPA will enter one of the three proposed generic names in part I, section C. fc Section B - IMPORTER IDENTIFICATION Enter the legal title of the organization filing this notice if it is not claimed confidential. If the legal title of the organization is claimed confidential, provide a description of the organization in accordance with section ill. Appendix A, Instructions for Asserting and Substantiating Claims of Confidentiality. ^ Section C - USE DATA I 1. If use data were not claimed confidential in section D. list the category(ies) of use that you reported in section D, Hem 2a. I Mark (X) if the use categories) is site limited, industrial, commercial, or consumer. Category of use (1) Site limited (2) Mark (X) appropriate box Industrial Commercial (3) (4) Consumer * " 2. If use data were claimed confidential, provide a description of the category of usefs) of the chemical substance in accordance with section ir. Appendix A, Instructions for Asserting and Substantiating Confidentiality. This description should be as specific as possible without revealing confidential information. Section 0 - TEST DATA Ust all test data concerning health and environmental effects of the manufacture, processing, distribution in commerce, use. or disposal of the new chemical substance that are being submitted, described, or cited as part of this notice. Provide a brief abstract of all test data on the new chemical sinstance that are submitted in accordance with 720.23(a) and 720.20(1). If physical-chemical properties are claimed con fidential. provide a generic description of these properties in accordance with section III, Appendix A, Instructions for Asserting and Substantiating Claims of Confidentiality. Afar* this box It you attach a continuation sheet. Page 15 Federal Register / Vol. 44, No. 201 / Tuesday, October 18,1979 / Proposed Rules PROPOSED laml jy United States Environmental Protection Agency PREMANUFACTURE NOTICE EXPORTERS FORM When completed tend this farm to: Document Control Otflcor Office of Tulc Substances, TS-793 U.S.E.RJL C)1 M Street, S.W. eehlnfton, D.C. 2MS0 EPA USE ONLY Date of receipt GENERAL INFORMATION The Premanufacture Notice form for exporters is divided into the following parts: Part t - General Information Part II - Human Exposure and Environmental Release Part III - List of Attachments Part IV - Federal Register Netice Part V - Optional Data ' The optional part (part VI is not included in this package. AH data reouested in the mandatory parts (parts I, II, III, and IVI must Pe reoorted to the extent they ate known to or reasonably ascertainable by the submitter. This means that the submitter is exoected to answer all questions to the best of his/her ability, including making reasonable estimates in cases where complete factual information is not available. If the submitter is unable to make a reasonable estimate (i.e., the data is not known and is not reasonably ascertainable), he/she should enter "NA" (not available). In part I, the submitter is required to report the specific chemical identity of the new substance, regardless of whether the informa tion is claimed as confidential. In accordance with proposed 5720.20(f), the submitter tnay authorize another person to report the specific chemical identity in his/het behalf. The notice will not be valid until the specific chemical identity is received by ERA. if (be space on the ton* is not sufficient to adequately answer e question, the suPmitter may attach additional sheets. Identify any continuation py part, section, subsection, and item. ASSERTING AND SUBSTANTIATING CLAIMS OF CONFIDENTIALITY Read Appendix A. Instructions for Asserting and Substantiating Claims ol Confidentiality, for information on how to claim and substantiate confidential business information included in this form or in attachments to the form. Claims of confidentiality must be made in accordance with sections I and Hof these instruc tions. In addition, substantiation of all claims of confidentiality must be made In accordance with section IV of these Instructions. If you claim-any item in any attachment to this form confidential, see SPECIAL INSTRUCTIONS for attachments. Appendix A, Section II. Appendix B ``Examples." provides additional guidance for asserting and substantiating claims of confidentiality. In accordance with sections I and II of the confidentiality instruc tions, claims of confidentiality must be made by using the follow ing tit categories: A. MANUFACTURER S IDENTITY , A claim of confidentiality for Category A, Manufacturer's identity, automatically includes items 1, 2, and 3 in parti, section A. B. SPECIFIC CHEMICAL IDENTITY A claim of confidentiality for category B, Specific Chemical Identity, automatically includes items 1. 2, and 3 in part I, section B. C. PRODUCTION VOLUME A cfaim of confidentiality for category C, Production Volume automatically includes item I in part I, section 0. These items do not need to be individually claimed. 0. USE DATA While use data itself is not required in the exporter's form, a manufacturer may claim information on the form confidentiai because it reveals confidential use data. E. PROCESS INFORMATION A claim of confidentiality for category E. Process Information, automatically includes items in part II, section A, subsection 2. These items do not need to be individually claimed. F. OTHER INFORMATION * Ne items on the form are automatically included in this category. Thus all claims for this category must specify category F. GENERAL CERTIFICATION 1 hereby certify to the best of my knowledge and belief, that: a. The company named in section A. item I, intends to manufac ture, solely for export, the chemical substance for which this notice is submitted, other than in small quantities for research and development, and that the substance is not excluded from premanufacture notification <40 CFR 720.13); b. All information entered on this Premanufacture Notice form is complete and truthful as of (he date of submittal; and c.l am submitting with this form all test data in my possession or control concerning effects of the substance on health or the environment and a description of any other data known to or reasonably ascertainable by me, in accordance with 40 CFR 720.23. I also agree to permit access to, and the copying of records by a duly authorized representative of the EPA Admmistratorm accord ance with the Toxic Substances Control Act and any regulations issued thereunder, to document any information reported in this form. Signature of authorized official Date CONFIDENTIALITY CERTIFICATION I hereby certify to the truth and accuracy of the following foix statements concerning all information which is claimed confidential. a. My company has taken measures to protect the confidentiality of the information, and it will continue to take these measures: b. The information Is not, and has not been, reasonably obtain able by other persons (other than governmental bodies! by using legitimate means (other than discovery based on a showing of special need in a jixlicial or quasi-judicial proceeding! with out the company's consent; e. The Information is not publicly available elsewhere: and <- Disclosure of the information claimed confidential would cause substantial harm to my company's competitive position. Signature of authorized official Date EPA Form 7710-27 (9-79) 59867 59868 Federal Register / Vol. 44, No. 201 / Tuesday, October 16, 1979 / Proposed Rules Port 1 - GENERAL INFORMATION Section A - MANUFACTURER IDENTIFICATION The answers to items 1, 2, and 3 will tie included in this claim. If you claim the answers to items 4 or 5 confidential, place the letterfs) A-F In the bos which indicates the basis of your claim and answer the linkage questions in appendix A, section II, for categories A-E. 1 Person Filing Notice Name of authorized official Organization Title ' Mailing address iNanbar end street) City, State, ZIP code Confiden tial code . ' % '' __ . , 2. Technical Contact Name Mailing address (Number and afreet) City, State, ZIP code - 1. Parent Company Name Mailing address (Number end street) City, State, ZIP code Title . _ j Area code J Number Telephone i i - P'; ssfe.... jpp" ^ -* fe ? 4. Enter the intended date of commencement of manufacture for export. Month Tear If the intended date of commencement of manufacture is more than 3 years after the date of this notice, submit evidence of intent to manufacture in accordance with 40 CFR 720.20(h). 1 I Mark this box it you attach evidence. ----------------------------------------------------------------------------- 1---------------------- S. If you have had a Prenotice Communication (PC) concerning this notice and EPA assigned a PC number to this notice, enter PC Number II UItanrokn<ex)........- r1~I1 CONTINUE WITH SECTION B ON PAGE 3 AS*. Federal Register / VoL 44. No. 201 / Tuesday, October 16.1979 / Proposed Rules________ 59869 k Section B - CHEMICAL IDENTITY ' If you claim Chemical Identity confidential, mark (X) the box at the tight The anan.cn to item* 1, 2, and 3 mill be included in this claim. ------ If you claim Chemical Identity confidential. Is this claim limited to the period prior to manufacture? t |_j Yes a [_J No If you claim the answer to item 4 confidential, place the letter!*) A-F in the box which Indicates the basis of your claim and answer the linkage questions in appendix A, section II, tor categories A-. _ P1 1 Complete either 1, 2, or 3 as appropriate. Complete 4. 1. Class 1 Chemical Substance (other than polymers) a. CAS Registry No. (if known) b. Specific chemical name ' ' c. Molecular formula d. Synonyms a. Trademarks Confiden tial code -. f. Structural diagram ,, - V. . 1 lifartt this box if you attach a continuation sheet. 2. Class 2 Chemical Substance ^ Re*'*,r* No- <*' known> b. Specific chemical name e, Synonyms A Trademarks . a. List the immediate precursor substance(s) and reactants with their respective CAS Registry Numbers) and describe the nature of the reaction. Also provide a partial or incomplete chemical structure diagram (where appropriate). Indicate the range of composition. B&.. - . -. sV - ' - [_J Mark this box if you attach a continuation sheet. Page 3 . 59870 Federal Register / Vol. 44. No. 201 / Tuesday, October 18.1979 / Proposed Rules 3. Polymers a. (1) Provide the specific chemical names and the CAS Registry Number of those monomers and other reactants used in the manufacture of the polymer. (2) Mark (X) the identity column if you wish monomers used at two percent (by weight) or less to be listed as part of the polymer description on the inventory. (3) Provide the intended range of composition of the polymer in terms of monomer percent (by weight). If your notice is for any copolymer of the listed monomers, enter "any" under Range of Composition. (4) For each monomer, indicate the maximum amount (weight percent) that may be present as a residual in the polymer as distributed in commerce. ' Monomers and CAS Registry No. (1) Identity Mark (Xj (2) Range of composition (3) Maximum amount (weight percent) (4) Confiden tial code (5) ' ~ -' b. Indicate the minimum average molecular weight or the minimum degree of polymerization of the polymeric compositions ' to which this notice applies. * O^artr this box if you attach a continuation sheet. 4. Impurities (a) List each impurity, including CAS Registry Number, which may reasonably be anticipated to be present in the chemical substance as it will be manufactured for commercial purposes, (b) Estimate the maximum percent (by weight) of each impurity. Base your answer on information developed during R & D activities, your knowledge of manufacturing process chemistry and anticipated quality control operations, (c) Mark (X) if the concentration of an impurity will be specifically controlled because of your concern about potential adverse health or environmental effects, (d) Estimate the maximum total percent (by weight) of the impurities that may be present. - Impurity and CAS Registry number (a) Maximum percent present (b) Mark It to be specifically controlled (c) Confiden tial code % % % * * 4b % | | Mark this box It you attach a continuation sheer. 4. Total percent---------------------------- % Section C - GENERIC NAMES Complete this section only if Specific Chemical Identity is claimed confidential. For instructions on how to develop generic names, see appendix II, 40 CFR 720 (44 FR 2278), Proposed Premanufacture Notification Requirements and Review Procedures. . Enter the generic name agreed on by EPA in Prenotice Communication Of provide 3 generic names. Page 4 Federal Register / Vol. 44. No^201 / Tuesday. October 18.1979 / Proposed Rules 59871 F Section D - PRODUCTION AND MARKETING DATA If you claim Production Volume confidential, mark (X) the box at the right.----------------------------The answers to item 1 will be included in this claim. - If you claim the answers to items 2 or 3 confidential, place the letters) A-F in the box which indicates the basis of your claim and answer the linkage Questions in appendix A, section II for categories A-. If you claim any item submitted in an attachment confidential, see SPECIAL INSTRUCTIONS, appendix A, section II, part B. 1. Estimate the minimum and maximum annual production volume for the first three years of production. Include in your estimates production by others with whom you have contracted to manufacture the new chemical substance. Production year (1) Production (Kg/yr) Minimum . (2) Maximum (3) Confiden tial code a. First year b. Second year c. Third year 2. Reentry into the United States Will the new chemical substance reenter the United States within the first 3 years of production -- . a. In bulk form? ' b. As part of a mixture? i Q Yes zO No 3| 1 Don't know iQJYes 2QNo 3QJ Don't know . ' c. As part of an article? i| I Yes 2QN0 3[ | Don't know ' ^ 3. Has the chemical substance been manufactured before? 'Yes 2QNo 3| | Don't know 4. Hazard warnings __ Attach to this notice a copy or reasonable facsimile of any hazard warning statement, label, labeling, marking or instructions, technical data sheet, material safety data sheet, and any other information which will be provided to any person regarding the safe handling, transport, use. disposal, treatment upon accidental exposure, or the formulation, construction, or labeling of products containing the chemical substance. t j Mark this box it you attach a hazard warning. CONTINUE WITH SECTION E ON PAGE 6 Pages / 59872 Federal Register / Vol. 44. No. 201 / Tuesday, October 16,1979 / Proposed Rules k Section E - TRANSPORT It you claim ttie answers to items 1 or 2 confidential, place the letter(s) (A-F) in the box which indicates the basis of your claim and answer the linkage questions in appendix A, section II for categories A-E. J. Enter the proper OOT shipping name and hazard class of the new chemical substance (if applicable). a. Shipping name - Confiden tial code . 0. Hazard class 2. Mark (X) the models) of transport which you believe will be used for the new chemical substance - a. Within the United States ' t [3 Truck s [~~1 Barge, vessel s Q Plane 2 [3 Railcar a 0 Pipeline ' 6 1 1 Other - Specify------------------------------------------------------ b. From U.S. port of exit to destination i[3Truck 20 Railcar 3QBarge, vessel 0 Pipeline s0Plane *0 Other - Specify Section F - RISK ASSESSMENT If you claim any item submitted in an attachment confidential, see SPECIAL' INSTRUCTIONS, appendix A, section II, part B. If you have evaluated the health or environmental risks which may be presented by the manufacture, processing distribution in commerce, use, or disposal of the new chemical substance attach your evaluation. ("I Mark this box if you ariacft a risk assessment. k Section C - DETECTION METHODS If you claim the answers to item 1 confidential, place the letter(s) A-F in the box which indicates the basis of your claim and answer the linkage questions in appendix A, section II, tor categories A-E. 1. Is an analytical method available to identify and quantify the presence of the new chemical substance - a. In workplace air? Identify . In workplace air? Quantify t 0 Yes 2 0 No 10 Don't know t 0 Yes 2 0 No 10 Don't know Confiden tial code b. In effluent streams? i 0 Yes 2 0 No c. In materials requiring disposal? t0 Yes 2 0 No d. In end products for which the new substance is an intermediate? 0 Yes 2 0 No s 0 Don't know f. In effluent streams? t 0 Yes 2 0 No 10 Don't know |. In materials requiring disposal? t 0 Yes 2 0 No 3 0 Don't know b. In end products for which the new substance'is an intermediate? i 0 Yes 2 0 No 10 Don't know 10 Don't know 10 Don't know PateS Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed RuleB 59873 Port II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE Section A - INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER If you claim Process Information confidential, mark (X) the bos at the right ------------------------------ The answer to subsection 2 will be included in this claim. If you claim the answers to items in subsections 1, 3, or 4 confidential, enter the letter!s) A-F in the box which indicates the basis of your claim and answer the linkage questions in appendix A. section II for categories A-E. If you claim the answers to Items 3.3, 4.3, or 4.4 in subsections 3 or 4, or any items submitted in an attachment confidential, see SPECIAL INSTRUCTIONS, appendix A, section II, part B. Complete a separate subsection 1 and subsection 2 sheet for each site where you will manufacture or process the new chemical substance. Subsection 1 - PROCESS INFORMATION Confiden tial code 14 Identity of site Name Physical location address (Number and street) City, County, State, ZIP code 14 Type of site i Manufacturing 21 | Processing 31 | Continuous Batch 14 Hours of operation Days per year Hours per day L4 Amount manufactured or processed -- Minlmiftn Kg/yr. Maximum Kg/yr. Subsection 2 - BLOCK DIAGRAM 24 Provide a block diagram identifying the major unit operations and chemical conversions. Also include: a. For each chemical conversion in the block diagram identify the major chemical reactions and the major side reactions. . b. Provide the approximate mass of all feed materials, byproduct materials, and products which are entering and leaving each maior unit operation and chemical conversion. Indicate the method of transfer of these materials and whether the operation is open or closed to the workplace environment. c. Identify thosppoints in the block diagram from which there will be releases of the new chemical substance or byproduct materials into the air, land, or water environment. vtfiwvsi* Mark this box It you attach a continuation sheet. Page 7 t rHiHa aianew... 59874 Federal Register / VoL 44. No. 201 / Tuesday, October 16,1979 / Proposed Rules SubJtdlon 3 - OCCUPATIONAL EXPOSURE Complete a separate subsection 3 for each site at which you will manufacture, process, or dispose of the new chemical substance. Indicate the anticipated route(s) of exposure to the new chemical substance (e.g., inhalation, ingestion, dermal), the number of employees anticipated to be exposed by each route and the maximum duration of such exposure tin days per year and hours per day). In the table below, mark (X) A-Average or P-Peak for the concentration levels that are expected to be present in the immediate vicinity of the process equipment. Base your answer on maximum annual production or processing during the first 3 years of manufacture under normal operating conditions with all engineering safeguards in place. 3J Identity of site Name Physical location address (Humber end street) City, County, State, ZIP code Confiden tiat code 3.2 Occupational Exposure at Industrial Site Concentration Activity (1) a. Manufacture b. Processing c. Disposal Exposure route(s) (2) exposed (3) Maximum duration (4) Hr./day JOays/yr. 1 1 1 1 1 1 1 1 1 measure i ppm * 0 mg/m3 r Qppm a O mg/m3 l 0ppm a 0 mg/m3 (S) Mark fX> appropriate column A - Average P - Peak 0-1 1--to 10- too >100 A PA P A P AP 3.3 Describe those operations in which workers will be directly exposed to the new chemical substance. IL (~) Mark this box II you attach a continuation sheet. 3.4 Mark (X) as many of the physical states of the chemical substance to which workers may be exposed in the workplace.- >0 Solid s (~~1 Aerosol sQMist 7 0 Dust > I I Other - Specify^ 7 0 Gas a Powder s I I Fume Liquid ___________________ 3.S For each site of manufacture, list any other substances (e.g., byproducts, co-products, feedstocks and intermediates) associated with the manufacture of the new chemical substance that may reasonably be anticipated to be present in the Substance (1) CAS Registry Number (2) Confiden tial code Confiden tial code V O Mark this box II you attach a continuation sheet. Page 8 Pe 9 I 59876 Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules Section B - INDUSTRIAL SITES CONTROLLED BY OTHERS Complete this section using your own forecasts, any information already obtained from other persons who may manufacture (under contract) or dispose of the new chemical substance,or any other information that is reason ably ascertainable. Complete a separate subsection 1 and subsection 2 for each site where you expect other persons to manufacture (under contract), or dispose of the new chemical substance. If you claim the answers to the Items in subsections 1, 3, or 4 confidential, enter the letterfs) A-F in the box which indicates the basis of your claim and answer the linkage questions in appendix A, section II, for categories A-E. If you claim the answers to items in subsection 2, or item 3.3 in subsection 3 confidential, see SPECIALINSTRUCTIONS in appendix A, section II, part B. . > Subssctlon 1 - PROCESS INFORMATION Confides tial code 1J Identity of site Name Physical location address (Number ana street) City, State, ZIP code County sg&s?. v .... * Subsection 2 - PROCESS DESCRIPTION Briefly describe manufacturing operations conducted by others. D Uark this bos It you attach a continuation sheer. Page to Federal Register / Vol. 44, No. 201 / Tuesday, October 18,1979 / Proposed Rules________ 59877 Subsection 3 - OCCUPATIONAL EXPOSURE Complete a separate subsection 3 for each industrial site where you expect other persons to manufacture or dispose of the new chemical substance. Indicate the anticipated routes of exposure to the substance (e.g.. inhalation, ingestion, dermal), the number of employees anticipated to be exposed by each route, and the maximum duration of such exposure (in days per year and hours per day). In the table below, mark iX) A-Average or P-Peak for the concentration levels - that are expected to be present in the immediate vicinity of the process equipment. Base your answer on the maximum amount anticipated to be manufactured or disposed during the first 3 years of operation under normal conditions with all engineering safeguards in place. 3 J Identity of site Name Physical location address (Humber ana street) fiflUfitf11"* tiai code yfo City. State. ZIP code I County & SJ Occupational Exposure at industrial Site Activity (1) a. Manufacture b. Disposal Exposure route(s) (21 Maximum flyfqfrpf exposed (3) Maximum duration . Unit of (4) measure Hrs./day {Days/yr. 1 i 1 l 1 1 ----- * i Qppm a mg/m> ' Ppm a rng/mt Concentration (5) Mark IX) appropriate column A - Average P - Peak , ^c ' 0-1 1--10 10-100 > 100 A P AP A P A P " * 3J Describe those activities in which workers wilt be directly exposed to te new ii substance. D Hark this box it you attach a continuation sheet. 3.4 Mark (X) as many of the physical states of the new chemical substance to which workers may be exposed in the workplace. iQ Solid s Q Aerosol sQMist 7 Dust Other - Specify^ 2 Gas Q Powder e Fume sQ Liquid _______ Page 11 Confiden tial code 59878 Federal Register / Vol. 44, No. 201 / Tuesday. October 16,1979 ,/ Proposed Rules Subsection 4 - ENVIRONMENTAL RELEASE AND DISPOSAL Complete a separate subsection 4 for each site where other persons intend to manufacture (under contract) or dispose of the new chemical substance. . 4.1 Identity of site Name Physical location address rNumber and street) Confiden tial code City, State. ZIP code County . 4.2 Indicate the duration of release into the air and water environment and the annual amount of new chemical substance released to the air, water, and land. Mark (X) the disposition of the water discharge and estimate the effluent flow rate from the site. Enter the name of the POTW or receiving water body. Base your answer on maximum annual production during the first 3 years of manufacture under normal operating conditions. '' K- ! ' .... .. A- a. Air b. Land Media (1) Duration of release Hrs./day (2) Days/yr. (3) Amount of new chemical substance released (Kg/yr.) Less than 10 (4) 10 100 (5) 10O1000 (6) 1000 10,000 (7) More than 10,000 (8) % -. c. Water 1 POTW (Publicly Owned Treatment Works) 2 Navigable waterway . 3 0 Other 1 Enter name |* ' -------------------------------------------------------------------------------------------------------- -----|---------------------------------------------------------------------------------------------------------------------------------------------- d. Effluent stream flow rate --i Gallons per day 4.3 (11 List any byproduct materials containing the new chemical substance that are generated during manufacturing and processing operations and which are disposed of (e.g., landfill, incineration, or other physical/chemical treatment). Water effluent and air emission streams should not be listed here. Estimates of release of the new chemical substance contained in such streams are required to be reported in item 4.2. (2) Indicate the method of disposal. (3) Estimate the amount of each material generated (Kg/Kg of the new chemical substance), and (4) estimate the percent (by weight) of the new chemical substance. Material requiring disposal (1) Anticipated method of disposal (2) Amount (Kg/Kg) (3) Percent of new chemical substance (4) Confiden tial code - O Mark this box it you attach a continuation sheet. Page 12 Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules 59870 Port III - LIST OF ATTACHMENTS ' Under section 5(d)(1)(B) and (C) of TSCA and 40 CFR 720.23, a manufacturer must submit all test data in his possession and control, and a description of any other data that are known to or reasonably ascertainable by him/her concerning the effect of manufacture, processing, distribution in commerce, use, or disposal of the new chemical substance on health or the environment The regulations specify which data must be submitted with the notice and which data may be referenced by literature citations. Using the categories provided, identify (1) attachments containing test data, descriptions of data, or literature citations in accordance with 720.23; (2) other attachments required to be submitted with this notice; (3) confidentiality substantiations and (4) attachments which contain information voluntarily submitted. All attachments should be clearly identified and numbered. To assert and substantiate a claim of confidentiality for any information included in the following attachments, follow the instructions in Appendix A, section II, part B. Note - Special directions for test data or other "Health and Safety" studies included in section III, part C. The instructions provide that you must also submit a "sanitized" copy of the attachment with all information that you are claiming confidential deleted. EPA will place this copy in the public docket. "" 1 Attachment name 1 Attachment number ----------------------------------------------------------------------------------------------------------------------------------------------------------,----------------------------------- --- a. Physical and chemical properties data . --------------------------------------------------------------------------------------------------------------------------- ' I * [ ....... ! , `1 b. Health and environmental enecu odu '" 1 1 1 1 1 1 I | i i i i i C' attachments * i t Part ! Section/Subsection | Item | 1 '! 1 1! i1 1 '! '1 1 ' ! ' 1j | i .| d. Confiden- tialitv attachments ' I '! 'i " ' 1j ---------------------------1------------------------------------------ j----------------------------------------- 1----------------------------------------- I I1 ' i| "] 1------------------------------------------1 ... a. Voluntary attachments L---------------------------------------- 1---------------------------------- j---------------------------------- 1i ,' --j--------------------------------------- i 1i ) I. 1 ....... ! *----------------------------------------1 [ 'i ! i ... 1 ' ! 3 Mark this box if you attach a continuation sheet. . Page 13 59880-59882 Federal Register / Vol. 44, No. 201 / Tuesday, October 16,1979 / Proposed Rules Port IV - FEDERAL REGISTER NOTICE Information provided in this part will be published in the Federal Register in accordance with section 5(d)(2) of TSCA. Do not enter any information in this part for which you have asserted a claim af confidentiality. Section A - CHEMICAL IDENTITY Enter the specific chemical name of the substance if it is not claimed confidential. If the chemical identity is claimed confidential, enter the name agreed to by EPA In Prenotice Communication or EPA will enter one of the three proposed generic names in part I, section C. Section B - MANUFACTURER IDENTIFICATION Enter the legal title of the organization filing this notice if it is not claimed confidential. If the legal title of the organization is claimed confidential, provide a description of the organization in accordance with section III, Appendi* A. Instructions for Asserting I and Substantiating Claims of Confidentiality. ^ Section C - TEST DATA List all test data concerning health and environmental effects of the manufacture. Processing, distribution in commerce, use, or disposal of the new chemical substance that are being submitted, described, or cited as part of this notice. Provide a brief abstract of all test data on the new chemical siAstance that are submitted in accordance with 720.23(a) and 720JO(i). If physical-chemical properties are claimed con fidential, provide a generic description of these properties in accordance with section III, Appendix A, Instructions for Asserting and Substantiating Claims of Confidentiality. Mark this box It you attach a continuation sheet. |FR Doc. 79-31566 Filed 10-15-79 8:45 am) BILUNG CODE 6560-01-C Page IS United States Environmental Protection Agency Washington DC 20460 Official Business Penalty for Private Use $300 First-Class Mail Postage and Fees Paid EPA Permit No. G-35 VO SO'lHVD MVS IS "IVIO^'/tWOD S3HH1X31 (OVd i"!lHfc3w snoo S9 J22.SS0