Document v1z15YJOQMmD2Xqx71oRLxvXY

UNION CARBIDE CORPORATION 1 W> El I AMINO K Al Ijrvnt h s'ANl) 29 October 1982 TO R. E. Peele 511 Attached are letters from Don Heywoad and Doug Bess relating to UCC's compliance with the final rule requiring submission to EPA of certain unpublished health and safety information as authorized under TSCA, Section 8 (d). Please read them carefully and call me if you have any questions. Your files are likely sources of this information and will have to be searched for reportable information relating to the chemicals on the list. Send the reportable information to the appropriate HS&EA manager. I should receive the material about toluene and xylene. I would suggest that you try to have this work completed by November 17th. If the actual number of pages involved is small or if you have reason to believe your copy is the only one likely to surface, then I would suggest you copy all of the information for the divison. On the other hand, if a division has many reports and it is likely they will also be in UCC's centralized files, then I would suggest you make an itemized list of the memos or reports and submit that to the division HS&EA manager. Then, he can review the list and request copies for only those reports he cannot locate elsewhere. Notice also that we have to submit a list of on-going studies but that we do not have to submit data from these studies. This sounds like a tremendous task at first but the following exclusions are helpful in limiting the amount of information to be reported. 1. Chemicals not on list are excluded. 2. Published data is excluded. 3. Mixtures with small amounts of listed chemical as impurity are excluded. 4. Most physical property data is excluded. 5. Chemicals not made or processed by UCC are excluded. UCC 006736 6. Data submitted to EPA or to other federal agencies (without confidentiality claims) is excluded. 7. Material in files retired before December 31, 1979. 8. Measurements of a listed chemical in the workplace or environment prior to October 1977. Please call me if you have any questions. TLC:ka Attachment T. L. Collins / UCC 006737 INTERNAL CORRESPONDENCE UNION CARBIDE CORPORATION old ridgebury road, danbury, ct obbi7 To (Nemftl >vteon Location Ar Copy to U.S. General Occupational Health Committee Members U.S. Corporate Product Safety Committee U.S. Divisional Environmental Protection Coordinators Data Originating Dept Area Subject October 21, 1982 HS&EA P-2 Action Plan for Preparation of UCC Submittal under Sec. 8(d) of TSCA. Sirs: On September 2, 1982 a Final Rule was published in the Federal Register, effective October 4, 1982, requiring submission to the EPA of certain unpublished health and safety studies on identified chemicals or groups of chemicals; the term "health and safety studies" includes studies of environmental effects. The authority for this rule is Sec. 8(d) of TSCA. Reports on the first-identified list of chemicals are due December 2, 1982, and subsequent reporting will be required on a continuing basis as new chemicals are identified or studies undertaken. The purpose of this memorandum is to establish an action plan for reporting by Union Carbide and to define working relationships, and mutual responsibilities of the Corporate Health, Safety and Environmental Affairs Department and involved Divisions as to reporting procedures and practices. Because of the breadth and continuing nature of the rule, all U.S. Divisions will eventually be affected and involved with reporting. The Federal Register notice is enclosed (Attachment V); most of the notice is preamble - the rule is pp. 38791-38799. Carefully note that Attachments II and III outline what should be reported as well as what need not be reported. Initial conversations with Division representatives and within the HS&EA staff have established that duplicative literature and file searches by each Division will be avoided if the package of basic, centrally located "health and safety studies" which are determind to be reportable is put together by members of the HS&EA staff or other centralized personnel. This "basic package" must be supplemented, however, by studies or reports that may be in Division files; more important, the Divisions ,must identify chemicals which they have "manufactured or processed" within the ten years prior to the effective date of the rule for which reporting may be required. Consequently, an "ad hoc" task group of HS&EA staff consisting of the following has been established to develop the plan for reporting and to coordinate the actual reporting: F.D. Bess, J.J. Brezinski, N.W. Gaines, R.G. Hanlon, D.L. Heywood (Chairman), and T.R. Tyler. Division representatives are hereby requested to do the following by the dates indicated. UCC 006738 2- - 1. What domestic Divisions are requested to do. (and completion date) a. Identify a single Division contact for the effort. (November 4, 1982) b. Identify chemicals on the first list (see Attachment pp. 38791-38798) which the Division manufactured or processed since October 1972 and for which, therefore, submission of any applicable health and safety studies is required. (November 17, 1982) c. Itemize any known studies in Division files for which reporting may be required. (November 26, 1982) d. Develop a Division management review system by which the Division may approve, request confidentiality treatment for, etc. any studies which the Corporation must submit on chemicals which the Division manufactures or processes. (November 26, 1982) e. Communicate the conclusions of the Division review of, the proposed submission to HS&EA. (December 2, 1982) Simultaneously, the HS&EA task group is undertaking the following actions by the dates indicated. 2. What HS&EA is doing (and completion date). a. Develop and initiate action plan (October 22, 1982). b. Collect and itemize reportable health and safety studies from centralized files - Bushy Run, Corporate Applied Toxicology, Corporate Medical, HS6EA Product files, R*D Environmental files, etc. (October 18 - November 24, 1982). c. Provide "mid-course" status report and improved guidelines to all Division contacts (November 17, 1982). d. Provide completed proposed report to appropriate Divisions for review, identification of confidential information, and request approval (November 24, 1982). e. Prepare final submission and submit to EPA (December 10, 1982). These parallel activities are presented as charted against time in Attachment I. Obviously, this simultaneous identification and compilation of reportable studies will require extensive communication and coordination. Division contacts should consult with the task group member in the identified area of responsibility as we proceed: P. D. Bess, environmental; N. W. Gaines, Occupational Health; R. G. Hanlon, Industrial Hygiene; D. L. Heywood, general; T. R. lyler, toxicology; J. J. Brezinski or C. B. Colwell, specific chemical information. UCC 006739 -3- 3. What must be reported. Examples of "health and safety studies" which qualify for reporting are given on p. 38791 of the attached rule, and discussed elsewhere in the text. A summary list of the kinds of studies is included herewith (Attachment II) along with a list of what need not be submitted (Attachment III) as specifically excluded in the rule. In general, unpublished reports or lists of ongoing studies (or those of which we are aware but which are not in our possession) must be reported. The present rule is significantly less onerous than the rule which issued in 1978 (with which UCC complied on a Corporate basis) which was subsequently withdrawn. In general, any reports previously submitted to EPA or other Federal Agency, published in outside literature, studies on non-Inventory chemicals (i.e., R i D compound) or on most mixtures need not be reported. It has also been determined that reviews, evaluations, or assessments of collections of available reports, for purposes such as management actions, decisions as to reportability under Sec. 8(e) of TSCA, or for setting workplace standards etc. do not qualify as "health and safety studies" for purposes of this rule. 4. "Starter" List of Chemicals for UCC Reporting Consideration. Since identification of chemicals which have been manufactured or processed within the Corporation during the past ten years is a massive chore and time is not unlimited, we are enclosing a "starter list" of chemicals which the Committee has been able to identify. (Attachment IV). We are augmenting this with input from Dr. Colwell'sInventory, which is complete only for compounds manufactured during 1975-1979 and partially complete for chemicals processed during 1975-1977. There is no way any Corporate group can identify all chemicals for consideration of reporting, however, and we must depend on each Division to be accountable for identifying chemicals on the current (and subsequent) lists for reporting. It is imperative that each Division initiate this effort immediatetly, since experience with the Inventory in 1979 and, more recently. Sec. 8(a) (among other efforts) has shown us that complete compilation of such chemical lists is not simple. Your help in identifying chemicals which are part of businesses which UCC has either dropped or sold is also requested. Meanwhile, the Task Group is proceeding to identify health and safety studies which may warrant reporting based on the "starter list", but (again) each Division is requested to examine its own files. 5. Miscellaneous Definitions. a. Manufacture includes, as with the rest of TSCA, to import for commercial purposes. "Process" includes, in our definition, to blend, repackage, repurify, otherwise prepare for further distribution in commerce, or to use as solvent or a chemical reactant in the manufacture of other chemicals. We are requesting that a Division who has product accountability for a particular chemical also accept the accountability for identifying chemicals and pertinent "health and safety" studies on chemicals used in the manufacture of that chemical for purposes of complying with this rule, even if another (host) Division may actually perform the processing. "Process" does not include handling chemicals for maintenance, repair, cleaning, etc. or other purposes which clearly are "use" UCC 006740 -4- purposes, including the manufacture of articles. For purposes of definition of "manufacture" or "process" in situations which are not totally unamibiguous, please contact the undersigned or another member of the committee; it is important that we arrive at decisions that are both correct and consistent across the corporation; this same request applies to other definitions, standards, scope etc. for this rule, such as "what is a 'health and safety study'*. b. Retired Files for purposes of describing those files which need not be searched if retired prior to December 31, 1979 means "records separated from those records in active use". c. The mixture reporting is complex, but conversations with EPA have indicated that the required reporting mixtures^ (716.9 (c) (1), (2), and (3)) is to be interpreted that mixtures are not excluded from reporting if, e.g., they should contain a small amount of a stabilizer in admixture with a reactive monomer which was really the subject of the study and which is on the list for required reporting. d. Broad studies directed toward plant atmospheres, community air, employee epidemiology studies, are generally reportable only (a) if one or more of the chemicals studied are on the list requiring reporting and (b) such studies are undertaken with a view to gathering specific data for purposes or relating the information to health or environmental effects; conversely, sporadic gathering of data apart from a purpose of conducting a study to relate specific chemicals to health and environmental effects are generally not reportable. For example, environmental impact analyses (to the extent they are based on calculated rather than measured concentrations) or effluent stream analyses are generally not reportable. In any event, to qualify for reporting, specific chemicals must be on the published lists for which reporting is required. e. Physical properties are generally not reportable and most often are published data anyway. Exceptions, however, are specific chemical properties conducted for purposes of health and safety studies, and will consist, for UCC's reporting requirements of physical property data contained in other reports such as Bushy Run studies, octanol/water distribution coefficients, and the like. f. Contract studies done, e.g. at Bushy Run, Oak Ridge, or the Corporate Aquatic & Environmental Sciences group are to be reported by the organization which sponsors the study. g. Joint Industry studies such as under CMA panels, SOCMA, etc. may be reported by any participating company if they have not been previously submitted to the EPA or another Federal UCC 006741 -5- Agency. In this regard, summaries or synopses of such studies are not considered submissions of the studies themselves, and one company should submit the actual studies and other members list the studies if reporting is required. h. Future reporting on chemicals on this (first) list will be required for three years after the effective date of the rule, i.e., up to October 1985; specific time-related reporting rules exist for handling studies presently underway or for studies initiated during the next three years. i. An extension to the December 2 deadline for reporting on the first list will probably be granted and it is our intention to request an extension. Finally, please note that this reporting requirement is complementary to but distinctly different than the TSCA Sec. 8(a) reporting (manufacturing, potential exposure and release information) currently being developed by the Divisions for submittal prior to November 19, 1982. Further, the list of chemicals for the health and safety study (8(d)) report is different than that for Sec. 8(a), although there are some chemicals in common. Please call with questions: our work is laid out for us and what we are initiating will become a continuing reporting requirement for UCC - hence our standards and practices must be logical, legally correct, and consistent. I look forward to our first "checkpoints" in the action plan, viz., November 4, to learn who the principal Division contact is, and November 17 to learn what other chemicals on the list may require reporting because of having been manufactured or processed in your Division. Very truly yours, Attachment DLH/cas .S' D.L. Heywood, for the 8(d) Task Group UCC 006742 HEALTH AND SAFETY STUDY SUBMISSION PLAN TSCA SECTION 8(d) 10/18 10/25 U / l 11/8 11/15 11/22 11/29 12/6 12/13 ATTACHMENT II STUDIES TO BE REPORTED (Health and Safety Studies not Specifically Exempted.) Copies of Studies (Final Reports) o Any study of any effect of a chemical substance on health or the environment or on both, including: o Epidemiology Btudies (HS&EA will provide) o Industrial hygiene studies (occupational exposure) o Toxicological studies o Clinical studies o Ecotoxicological and related studies (includes specified physical and chemical properties) / ALSO: o Monitoring studies (October 4, 1977 to date) when aggregated and analyzed to measure the exposure of humans or the environment to a chemical on the list. List of Studies o List of ongoing health and safety studies initiated by UCC or being conducted for UCC. o Unpublished studies which UCC is aware of but does not have copies (those mentioned in UCC files subject to search). UCC 006744 ATTACHMENT III EXEMPTIONS FROM REPORTING o If published in the literature. o If previously submitted to EPA, including Section 4 rule proceeding or earlier Section 8(d) rule. o If submitted to other federal agencies (without confidentiality claims). o Those conducted for or initiated by other companies subject to reporting. / o Studies conducted on chemicals not on the TSCA inventory. o Heports of analyses of monitoring data developed prior to October 4, 1977. o Studies on products present as impurities (not isolated). o Underlying data, i.e. medical/health records, lab notebooks and daily monitoring records. o Most studies on mixtures. o Acute oral, dermal, inhalation toxicology studies, o Primary eye, dermal irritation studies, o Dermal sensitization, o Physical and chemical properties. UCC 006745 ATTACHMENT IV Starter List" for September 2, 1962 TSCA Sec. 8(d) Rule Chemicals which the Task Group identifies as being manufactured or processed within Union Carbide since October, 1972 1. Alkyl Epoxides: Ethylene Oxide Propylene Oxide Butylene Oxide Tetradecyl Oxirane 75-21-8 75-56-9 106-88-7 2. Glycidol Derivatives: Glycidyl acrylate Glycidyl Methacrylate Allyl Glycidyl Ether Phenyl Glycidyl Ether Methyl Glycidyl Ether Diglycidyl Ether* Bis Phenol A Silane A-187 106-90-1 106-91-2 106-92-3 122-60-1 930-37-0 25085-99-8 3. Balogenated Alkyl Epoxides: Epichlorohydrin 106-89-8 4 Other Halogen-containing Products Chlorobenzene, Dichlorobenzenes: 108-90-7 95-50-1 541-73-1 106-46-7 Higher Chlorinated 87-61-6 Benzenes 120-82-1 108-70-3 634-66-2 95-94-3 608-93-5 634-90-2 Methyl chloride 74-87-3 Methylene Chloride 75-09-2 5. Ketones: Cyclohexanone Isophorone Mesityl Oxide Methyl Ethyl Ketone Methyl Isobutyl Ketone 108-94-1 78-59-1 141-79-7 78-93-3 106-10-1 UCC 006746 / ATTACHMENT IV (Continued) 6. Nitrogen-containing Products: Acetonitrile Acrylamide Haloanillnes Bisazodiphenyl Dyes Pyridine p-Phenylenedianine 7. Aryl Phosphates: Trieresyl Phosphate 6. Alkyl Phthalates Di-2ethylhexyl Phthalate Other Plasticizers (phthalates) 9. Aromatic Hydrocarbons: Toluene o-Xylene m-Xylene p-Xylene 10* Phenols: o-Cresol m-Cresol p-Cresol Hydroquinone 11. inorganic Compounds: Antimony Antimony Trioxide Asbestos (several forms) 75-05-8 79-06-1 several several 110-86-1 106050-3 563-04-2 117-81-7 several 108-88-3 95-47-6 108-38-3 106-42-3 95-48-7 108-39-4 106-44-5 123-31-9 7440-36-0 1309-64-4 1332-21-4 -- 12001-29-5 12172-73-5 17068-78-9 UCC 006747 387110 ATTACHMENT Federal Register / VoL 47. No. 171 / Thursday, September 2, 1982 / Rules and Regulations ENVIRONMENTAL PROTECTION AGENCY 40 CFR part 718 (OPTS-W003A; TSH-FHL 2112-2] Health and Safety Data Reporting; Submission of Lists arid Copies of Health and Safety Studies aocncy: Environmental Protection Agency (EPA). ACTION: Final rule. summanv: This rule require! the submission of unpubUamKfhealth and safety sjhfflesdnspeclffciljy listed" chemicals by cbenucalmanufacturer*. processors, and others in possession of such studies. The rule is issued under section 6(3] of the Toxic Subetancet Control Act (TSCA), 1$ U.S.C. 2807(d). Hie Administrator will issue amendments in the Federal Register to add to toe list of chemicals subject to the rule. Amendments to-add chemicals recommended for testing by the Interagency Testing Committee (TTC). established under section 4 of TSCA, will be effective upon publication. Amendments to add other chemicals will be subject to a thirty-day comment period. This notioe promulgates the final version of regulations proposed on December 31,1979 at 44 FR 77470. tmcnvi OATC October 4,1982. TON FURTHER INFORMATION CONTACT! Douglas Bannennan. Acting Director, Industry Assistance Office (TS-799), Office of Toxic Substances, Environmental Protection Agency, Rm. E-511, 401 M Street, SW,, Washington, DC 20480. toll free (800-424-9065); In Washington, DC (554-1404); outside the USA (Operator-202-554-1404). tUFFlEMCrrANY INFORMATION: OMB Control Number 2070-0004. 'Background In the Federal Register of )ufy 18,1978 (43 FR 30984), EPA promulgated a previous version of this rule under section 8(d] pf TSCA (43 FR 30984) requiring reporting of studies of chemicals listed on the first fTC report That rule was challenged by the Dow Chemical Company and was subsequently revoked (see 44 FR 77470). Two provisions of that rule were the subject of a lawsuit Dow Chemical Company v. EPA. 805 P-Zd 873 (1979). The two provisions concerned obtaining studies on chemicals manufactured or processed for research and development purposes and obtaining copies of studies on a chemical from companies that do not manufacture, process or distribute that chemical. The Court upheld EPA's authority for both provisions. Purpose and Use of the Rule Under this rule, EPA will acquire unpublished health and safety studies on specified chemicals from manufacturers and processors of the chemicals. Hie Agency will use the studies to support its investigations of the risks posed by chemicals and, in particular, to support its decisions whether to require industry to test chemicals under section 4 of TSCA. The addition of chemicals to the rule will occur by notice of amendment in the Federal Register. In the case of chemicals recommended for testing by the ITC the amendment will be effective thirty days after publication. For other chemicals, the amendment will be subject to a thirty-day public comment period before promulgation. Studies of health and environmental. effects, including studies of exposures of people-srlhe environment are the fundamental ingredients of any assestmenf ofchemical risic For this reason. EPA will require reporting under this rule for specific chemicals that are under investigation either in early stages of risk assessment or when action to control exposure is being considered. Furthermore, EPA expects to require submission of unpublished health and safety studies for all chemicals under consideration for required testing under section 4 of TSCA. EPA will evaluate the studies reported under this rule together with other available data to construct a picture of the effects of chemicals and their associated risks. The studies submitted under the previously issued section 8(d) rule (43 FR 30984. July 18,1978), have been very useful in the Agency's investigation of the effects of the FTC-recommended chemicals covered by that rule. The studies have been used In designing appropriate tests, and in support of the basic decision whether testing for a particular biological affect should be carried out For example, studies submitted on chlorinated benzenes contributed significantly to EPA's design of a testing scheme for mutagenicity. The Agency, itself, will conduct these tests. Similarly, studies submitted on monochlorobenzene supported our decisions on the need for testing of the reproductive effects of that substance. These are examples of two important contributions that submitted studies can make to tearing decisions. Overview of Rule Requirements Extensive comment was received on the question of what records a company should search to comply with this rule. The proposal spoke of information "known to" or in the "possession" of respondents. The definitions given for these terms were broad, and comments indicated that under these definitions, companies would feel obliged to search many more records than we believe necessary. We have decided to replace die definitions with a description of the scope of a search that will be adequate for this rule. The rule now says that respondents are responsible for searching only the company files~in which they ordinarily keep studies and Ifie records keptt>y employees whose assigned duty is to adytaethe company on health'and environmental effects oL chemicals. Moreover, for all compliance purposes, respondents need not consult any records that they retired prior to December 31.1979, the date cm which this rule was proposedThe rule has two basic requirements: Submission of copies of studies in the possession of persons subject to the rule and submission of lists of studies ongoing at the time of submission or known to but not possessed by the submitter. Persons who are manufacturing or processing a chemical at the time it is listed in the rule, or are proposing to do so, are required to submit both copies and lists of studies for that chemdaL EPA decided to exempt distributors from reporting, because we believe that very few distributors perform these studies and that the burden to these persons outweighs making them aubject to the rule. An exantination of the respondents to the previous section 8(d) rule revealed that no distributors submitted studies. These reporting requirements remain applicable until the sunset date for the chemical (three years after the chemical is made subject to the rule) to cover studies begun during that period, and to cover persona who begin, or are proposing to begin, manufacturing or processing a listed chemical during that period. Persona who are not involved with a chemical when it Is listed but manufactured or processed it or proposed to do so any time during the ten years prior to the time it la listed, are required to submit copies of studies for that chemical, but are not required to list studies. Since the proposal, changes have been made regarding the types of studies that must be submitted. Several types have been exempted. The final requirements represent the Agency's effort to reduce the burden of the rule while still obtaining the most useful studies for our assessments. EPA received many good comments that allowed the Agency to UCC 006748 Federal Register / VoL 47. No. 171 / Thursday, September 2. 1982 / Rules and Regulations 387B1 identify the studies that were most burdensome to submit and least useful for its assessments. Therefore, the Agency has added to the exemptions originally proposed. The final rale has the following overall exemptions: (1) Physical and chemical properties other than ten that are specifically listed: (2) studies of a substance or mixture that a person has manufactured or processed, or proposed to manufacture or process as an Impurity; (3) published studies; (4) nob-confidential studies submitted previously to another Federal agency; (S) all studies previously submitted to EPA (this includes studies voluntarily submitted during section 4 proceedings or under the previous section B(d) rule]; (8) studies of chemical substances which are not on the TSCA Chemical Substance Inventory, Le- research and development studies on new chemical substances, and (7) underlying data such as medical records, monitoring data, and lab notebooks {unless the EPA requests the data later, by personal letter). In addition, certain types of studies of mixtures are exempted as stated below. In summary, the reportable studies are: (1) Studies of listed chemicals with the seven exclusions noted above; and (2) studies of mixtures containing listed chemicals with the seven exclusions noted above and also excluding: acuta oral toxicity studies, acuta dermal toxidty studies, acute Inhalation toxicity studies, primary eye Irritation studies, primary dermal irritation studies, and physical and chemical properties. Organization of This Preamble EPA received more than 100 responses to the proposed rale, each containing multiple comments. Several aspects of the rule received numerous comments; other aspects, only one or a few. In this preamble, the Agency discusses the major comment near specific definitions; chemical substances subject to the rale; lists and copies to be submitted and who should submit them: studies not subject to mandatory reporting; file search; reporting schedule and sunset provision; confidentiality; and economic impact The subjects that received only one or a few comments are individually discussed in a document entitled "General Comments on the Proposed Section 8(d) Rule" which is part of the public record. L Specific Definitions A. Manufacture and Process for Commercial Purposes EPA interprets the term "manufacture or process for commercial purposes'* to refer to such activities conducted, in whole or in part, for the purpose of obtaining a commercial advantage for the manufacturer or processor as distinguished from charitable or academic purposes. Therefore, chemicals manufactured for product research and development (R ft D), as well as byproducts and impurities of commercial manufacturing and processing, are "for commercial purposes.'' E3*A received comments saying that the Agency's interpretation is wrong because these substances themselves are not actually marketed, and. in the case of byproducts and Impurities, are not desired for the market However, the Agency considers it undeniable that products of commercial endeavors are mode for commercial purposes. Moreover, the reason that section 8 of TSCA exists Is to give the Agency access to information from which it can assess the nature and significance of chemical hazards and risks. TSCA is intended to address these hazards end risks to health or the environment whether or not the chemicals are desired commercial products. The commenters thought that the Inventory Rule exempted reporting of byproducts, impurities, end RAD chemicals because they ware not considered to be "for commercial purposes." On die contrary, this section 8(d) rale is completely consistent with the Inventory rale, both rules define these chemicals ea "far oommerdal purposes." The Inventory Rule exempted such subetanoet only because they wen not appropriate for Inclusion in the Inventory. In this final rule the Agency has limited the potential reach of this interpretation. A description of the applicability of the rale to impurities, byproducts, and R ft D chemicals follows. (1) Impurities. Under this rale, EPA has excluded from reporting any studies of chemicals that the person reportinghas manufactured or processed or has proprtedjdmanufactureor process only as'lmpuirftJeil ' Since the chemicals presently listed in the rale are marketed most widely as desirable products, rather than as impurities, EPA expects that the excluded studies will be so few ee not to Justify the burden of searching for them. However, in other circumstances, the Agency may propose to requin the excluded studies to be reported for some chemicals.* (2) Byproducts. It should be noted that the definition of "manufacture for commercial purposes" Includes only byproduct substances and mixtures that are separated from'the other substance or mixture that Is being manufactured, processed, used, or disposed of. Other substances that are produced as byproducts, but not separated.&om the product, are impurities ofJibe product. and are thus not covered in the present rule. This rule requires manufacturers of. these separated byproducts to report studies on them and on mixtures containing them. Thus, persons who manufacture a listed chemical as a known byproduct that they separate during manufacture, processing, use, or disposal of another chemical must report studies on the known byproduct EPA equates these studies with studies of the same chemicals as desired products. The studies will be just as telling on the effects of the chemicals. (3) R&D Chemicals. The Third Circuit has upheld EPA in its view that substances manufactured for R ft D purposes ere manufactured for commercial purposes. Dow t. EPA. 60S 7.2d 873 (3rd Clr. 1979). EPA discussed the importance of these studies in the preamble to the proposed rale end continue to regard them as important resources in investigating the effects and risks associated with substances. However, to minimize the burden of this requirement, EPA has exempted persons from reporting studies on chemical substances that are not on the TSCA Chemical Substances Inventory, e^. new chemical substances. When a premanufacture notice (PMN) is submitted on a new substance, any health and safety data on the substance would be submitted. R Propose to Manufacture. Process, or Distribute "Propose to manufacture, process, or distribute" is defined in this rule to mean that a person has made a management decision to commit financial resources toward the manufacture, processing, or distribution of a chemical substance or mixture. A company coaid commit financial resources by. for example, hiring additional personnel, commissioning a construction engineering plan, purchasing land to construct manufacturing or processing facilities, purchasing production equipment, or contracting for raw materials. One commenter stated that EPA should exempt persons that propose to manufacture, process, or distribute the listed substances because they would not have many studies. EPA has not adopted this suggestion. Valuable ihidies might be missed if these persona are exempted. The Agency-would be particularly interested in the results of a UCC 006749 38782 Federal Register / VoL 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations study which prompted a decision not to manufacture, process, or distribute a substance. Some commenters felt that the proposed definition covered actions too arty in a company's deliberations fend that "propose to" should not hinge on a management decision tp commit resources toward manufacture, but should require an actual management. decision to manufacture the chemical, e.g., building a plant The Agency recognizes that there are many individual decisions made prior to actual manufacture. Building a plant for instance, only moves e person toward the manufacture of s chemical. Until the substance is actually manufactured, all the actioqs management might make only move the company toward manufacture of the substance. These actions are considered here as "proposed" manufacture. Other commenters asserted that the meaning of "propose" is dear in the premanufacture notification provisions of section 5 where the requirement is to submit the notice at least ninety days before production. EPA disagrees. Section 5 requires a notice when a person "intends" to manufacture a new chemical substance, not when he "proposes" to manufacture. Whan a person Is ready to submit a section 5 notice, he ia beyond the initial stage in which he "proposes" to manufacture for purposes of section & The Agency has not changed the definition. The Agency believes it is as specific as a definition of such a concept can be. given the variability of businesses covered. C Health and Safety Study Many commenters argued that some of the examples of health and safety studies given in the proposed definition are not "studies" in their view. They argued that only studies designed to provide a direct measure of effects on human health or the environment should be included. They cited two kinds of studies they would exclude as not being direct measures. One kind was measurement of a chemical's concentration in the ' workplace or environment Another kind was measurements of properties of chemicals, such as: biological, photochemical and chemical degradation: air, water, and soil transport; and water solubility, vapor pressure, and octanol/water partition coefficient The Agency disagrees with this narrow view. The legislative history of TSCA indicates that Congress expects the Agency to collect a broad range of information relevant to health and environmental effects. It Is Intended that the term (health and safety studies) be interpreted broadly. Not only is information which arises as a result of a formal, disciplined study included, but other Information relating to the effects of a chemical substance or mixture on health and the environment is also included Any data which bears on the effects of a chemical substance on health or the environment would be included HJL Rep. No. 04-179, 94th Cong, 2nd Sees. 56 (1976) (Conference Report). All of the data EPA will obtain under this rule, bear on the effects of chemical substances on health or the environment When measurements of a chemical's concentration have been analyzed to draw conclusions about occupational or environmental exposure, a "health and safety study" has been done. Similarly, determinations of physical and chemical properties that relate to a chemical's potential for affecting health or the environment are "health and safety studies." (1) Measures of concentration. The final rule requires the submission of analyzed aggregates of measurements monitoring concentrations of a chemical In the workplace or environment. These are limited to analyses of data gathered within five yean of the effective date for reporting on the chemical. These studies bear significantly on the effects of a chemical on health or the environment For instance, if the Agency knows that a chemical never reaches the environment it would know that it will not have an effect on the environment Some of the concerns commenters had about submitting monitoring data were because they understood the proposal to say that all underlying data were to be initially submitted This would have meant submitting a very large amount of material. As explained below, underlying data are not to be initially submitted. (2) Properties ofchemicals. The final rule requires reporting on studies of ten properties when those studies are for the purpose of determining the environmental or biological fate of the substance: (a) Water solubility; (b) adsorption/desorption on particulate surfaces (e.g., soil); (c) vapor pressure; (d) octanol/water partition coefficient (e) density/relative density (specific gravity); (f) particle size distribution for insoluble solids; (g) dissociation, constant (h) degradation by photochemical mechanisms--aquatic and atmospheric; (i) degradation by chemical mechanisms--hydrolytic, reductive, and oxidative; and (j) degradation by biological mechanisms-- aerobic and anaerobic. These properties of a chemical are very important elements to consider in assessing its potential biological effects. For example, water solubility and partition coefficient bear on the question of whether a chemical could become deposited in body fat tissues. For another example, all of the properties .are informative on the questions of whether a chemical released into the environment would remain for a long time and be transported over a large area. EPA decided to narrow the requirements for submitting properties in an effort to reduce the reporting burden. There are other properties that are very useful but the Agency focused on these ten properties as being particularly informatiye, individually and together. Determinations of physical and chemical properties, together with the other studies, will give a picture of the chemical's exposure and effects which will permit effective evaluation of potential risks. An evaluation of the environmental fats of a chemical which is based on physical and chemical properties, that may be released to the emdrionment is of critical importance. It is possible that a highly toxic, easily degradable substance will be less an object of concern than a less toxic persistent chemical Recent technical reports have indicated the importance of environmental fate testing. Par chemicals that are likely to be released to the environment, environments! fats testing is equally as important as biological effects testing. For many chemicals, advene biological effects were discovered following extensive testing undertaken only after the discovery of widespread environmental contamination. (Sea Howard. P.H_ at si. Environmental Science and Technology. 12(4}. 407 (1076)). - Determining the fate of a chemical substance in the environment and. thus, its effects, may involve investigating the nature of dispersal and ultimate distribution, and the types and rates of reactions in which the chemical participates during transport Fate determinations help to identify the chemical form(s), the environmental compartments or concentration ranges to which the environment will be exposed, and the organisms exposed to the chemicaL (See 45 FR 77332, (proposed environmental test standards) for a further discussion of the importance of physical and chemical properties in determining the environmental effects of chemicals.) UCC 006750 Federal Register / Vol. 47, No. 171 / Thursday, September 2. 1082 / Rules and Regulations 38783 (3) Underlying data. Data such as individual monitoring records or employee medical records that may underlie an epidemiological or exposure study are not required to be submitted as initial reports under the rule. EPA may request these and other underlying data such as lab notebooks as a follow up to its examination of a study. The Agency does not anticipate making such requests very frequently. It will do so when a question of interpretation arises (such as when the Agency has studies whose results appear to conflict) and an examination of the underlying data may clarify the problem. D. Known to andPossession As previously discussed, the Agency has decided to delete definitions of "known to" and "possession" and, instead, describe the kind of file search that will suffice for compliance with this rule. From comments received on the. proposed definitions, it is apparent that the definitional approach to delineating a responsibility to search far studies is too indirect The matter is discussed further under the preamble section titled "File Search." . Chemical Substances Subject to die Rule Section 716.17 of the role contains a list of chemical substances subject to the rule. A subsection of i 710.17 is reserved for future listing of designated mixtures subject to the rale. The majority of the chemicals presently listed are ones for which the ITC has recommended that EPA propose testing rules. It is important that EPA review unpublished studies on these chemicals to avoid unknowingly proposing testing under section 4 that may already have been dona, and to base fudgmenta about testing on as full an overview of existing information as practicable. The goal is to focus proposals for tasting as efficiently as present knowledge will permit. The list in 1716.17 contains two groups of chemicals. One group consists of the chemicals recommended by the ITC for testing. The other group of chemicals includes the asbestiform varieties of chrysotile. croddoUte, amosite, intbophyilite. tremoUte, and actlnolite, Le^ asbestos, which is being considered for control. The bisaxobiphenyi (BAB) dyes were recommended for testing, and are the subject of a broader Federal effort Assessment actions are underway at CPSC and OSHA. In addition, the BAB dyes are being tested by CPSC (skin absorption) and at the National Center for Toxicological Research (metabolism studies). Several chemicals in the proposed list have been removed in the final rule. A subset of one category of chemicals, listed in the proposal as "organotina" (selected by EPA) was subsequently recommended for testing by the ITC, 45 FR 78432 (November 25.1980). The ITC had recommended the subset "alkyltine." However, the ITC has subsequently removed this category from the section 4(a) Priority List for reconsideration (47 FR 5459). EPA has deferred reporting on these and the other organotina for a later proposal. Another category of chemicals, acrylic add and methylacrylic add and their esters, has been removed from the rule. EPA will propose the category in a future Iteration of this rale after It has batter defined the category. Dioxin and related substances have also been removed from the rale. Since proposing their inclusion in this rale, the Agency has carried out administrative proceedings dealing with dioxin issues which have covered the ground that would have been covered by having the chemicals reported under this rule. Other chemicals removed from the rale Include acrylonitrile, alphachlorotoiuene. benzene, benzene (epoxyethyl), chlorendic anhydride, chlorodifluoromethana, 1.2dlchloroethane, 2-chloro-l,3-butadiene, ethyl benzene, iodomethane (methyl iodide), morpholine, nitrosodleihanolamine, 2-nJtropropane, and vinylbenzene (styrene). These chemicals were removed for a number of reasons. Some (eg., benzene, styrene) were tbs subject of earlier section 8(e) submissions and have since been referred to other EPA program offices or Federal agencies for study. The remainder were under early stages of assessment when they wen added to the proposed rale. In the intervening time, however, the Agency has brought some of these assessments to near completion, e.g, 2-nitropropane. Several comments argued that EPA did not provide adequate public notice and opportunity for comment because the Agency did not state in its proposal a reasoned explanation of how or why each particular chemical was selected. These comments said that the Agency must for each chemical, show that the information to be reported will contribute to articulated regulatory objectives. In particular, they stated that EPA must show why it believes that each chemical might pose a risk to health or (he environment and why published studies provide insufficient information for conducting a risk assessment, evaluating the need for testing, or considering other regulatory options. These comments also claimed the Agency must show for each chemical subjeot to (he rule that the Information requested is not available from other sources. EPA believes It has justified, to the extent required by section B(d), the need for reporting on the chemicals subject to the final rule. The Agency disagrees with the comments on the level of detail required to justify reporting. The comments would require that the Agency prepare an extensive chemical specific determination that would require a search of the entire scientific literature and aD available sources and a complete hazard analysis of the chemical. Thus, according to the comments, section 6(d) could be used. only to obtain information as a last resort. This is contrary to the Intent of TSCA. There is nothing In the language or legislative history of the Act to indicate that section 6(d) is to be used in such a manner. On the contrary, section 8(d) is meant to reveal information early in the Investigation phase. (See Report of the Senate Committee on Commerce. S. Rep. No. 898.94th Cong, 2d Sees. 8 (1978).) TSCA requires the Agency to provide only a general explanation of its concern before requesting unpublished studies on a chemical under section 8(d). Sufficient Justification is provided if the chemical is recommended for testing by the Interagency Testing Committee or if EPA staff judges that further data on the chemical axe needed for assessment EPA should not ignore the possibility of obtaining data under section 8(d) when a chemical is under evaluation by the Agency staff EPA particularly disagrees that it must show during a section 8(d) proceeding that a chemical may present a risk. Congress could not have intended the Agency to make a risk finding under a section of the statute that is designed to reveal the hazards of a chemical. As to the comment that EPA must indicate for each chemical that information required by this rule cannot be obtained from other sources, the final rule in fact accommodates this comment by excluding from rule requirements any studies available from sources to which EPA has access--published studies and studies submitted to other Federal agencies without confidentiality claims. The studies subject to the rule ere those not otherwise available to the Agency. Several comments argue that to provide adequate public notice and opportunity for comment EPA must in the proposed rule state for each chemical subject to section 8(d) that the information requested is not more detailed or extensive than necessary, UCC 006751 38784 Federal Register / Vol. 47, No. 171 f Thursday. September 2. 1982 / Rules and Regulations and will not burden more persons than necessary with reporting obligations. EPA concurs that as a matter of sound policy these factors should be considered by the Agency for this section 8(d) nile. but disagrees that it can prepare detailed assessments of these factors at the time it proposes a section 8(d) rule. In fact EPA has proposed this rule to solicit from the companies that obtain commercial advantage from the subject chemicals comments on whether reporting on their particular chemicals will be unnecessarily burdensome. These companies have or should have the knowledge to enable the Agency to make this decision. Indeed, the Agency has, in response to comments, eliminated tome types of studies and tome chemicals that were originally part of the proposal. Many comments objected to the Agency's automatically making subject to the rale chemicals recommended for testing by the ITC. These comments claim that recommendation for testing by the ITC la not sufficient to justify an automatic reporting requirement They argue that EPA must allow the public to present reasons why unpublished studies should not be collected in order to avoid imposing unnecessary or overly burdensome reporting requirements. The comments stated the following examples of situations in which the public should be able to comment on EPA's decision to obtain studies under this rule for ITC chemicals; EPA may be able to obtain unpublished studies on a voluntary basis; EPA may be able to make e decision to proceed with or abandon testing on the basis of information in band; EPA and the public may need to consider whether studies should be submitted on effects in addition to those of concern to the ITC; the ITC may have overlooked a crucial study In the literature; voluntary tasting may have been initiated or all manufacture and processing may have ceased. EPA does not And this reasoning persuasive. Within one year after the ITC recommends a chemical for testing, the Agency must Initiate a rulemaking proceeding to require testing under section 4 of TSCA or publish its reasons for not initiating such a proceeding. Because it hat such a short period of time to make this decision, the Agency must proceed as rapidly aa possible to gather available data on a chemical. To decide whether to propose a test rule within one year, the Agency needa to be able to complete its assessment of the known health and environmental effects of a chemical no later than the first four to five months after the ITC recommendation. If studies are reported automatically under this rule, the Agency will receive them by the end of the fourth month. On the other hand, if the chemicals were proposed for comment an additional two to three months would be required to give time for the comment period. EPA writing of responses to the comments, and EPA preparation and publication of a final rule. The Agency would then receive the studies by the end of the sixth or seventh month after the ITC recommendation. However, by this time EPA staff mutt complete their analyses for EPA decisionmaker* to consider. EPA has previously discussed in this preamble the Importance of section 8(d) studies in deciding whether to initiate proceedings to require testing and has discussed examples showing that unpublished studies submitted previously have been valuable in section 4 proceedings. Receipt of significant stadias at this lata stage that could causa fundamental revision of the basic analyses would make it impossible to meet the Agency's oneyear deadline. Tha Agency has also considered in this section 8(d) proceeding a large number of Issues relating to reporting of . unpublished studies. The Agency baa been unable to determine, mid no comments have been presented to indicate, that any other issues would be raised in e comment period that would lead the Agency not to require section 8(d) studies on ITC-recommended chemicals. Most of the examples described above of situations in which the public should be able to comment on decisions under section 8(d) on ITC chemicals are reasons why chemicals should or should not be tested under section 4. This section 8(d) rule to not for determining whether to proceed with testing under section 4, but to to be used to obtain information to assist in section 4 decisions. Most of the situations described by the comments, therefore, would not be relevant to a section 8(d) proceeding. Further, EPA will not delay section 8(d) proceedings while it considers whether to wait for studies to be submitted voluntarily. The Agency has found that, while stadias may be voluntarily submitted in some cases, all companies will not do so. Inquiring after voluntary submissions to a highly inefficient use of Agency time and resources and would unnecessarily delay input into the section 4 test rule process. EPA's economic analysis shows that the costs of searching for studies on ITC chemicals in accordance with the procedures set forth in this rule will be very small Further, the Agency expects that in the future companies will : establish a syBtem to enable more efficient retrieval of studies requested under section 8(d). After considering these costs against the relatively quick need the Agency bas for studies of ITC chemicals, EPA has determined that such chemicals should become subject to the section 8(d) rule as soon as possible after the ITC recommends them. HL Lists and Copies to be Submitted and Who Should Submit Them The rule includes two types of submission requirements--the requirement to submit copies of health and safety studies, with an appropriate index, and the requirement to submit lists of certain additional health and safety studies. A. Requirements for Submitting Copies ofStudies Two requirements to submit copies of studies will apply. First any person who has manufactured or processed or who has proposed to manufacture or process a substance or designated mixture listed in { 718.17, within the ten years preceding and including the date (he chemical to listed, will be required to submit copies of any unpublished studies he possesses on that chemical Second. EPA may request copies from persona other than manufacturer* and processors of the chemical when such persona are identified aa possessing studies listed by someone else in accordance with f 716.12. Such persons would be requested to submit these studies voluntarily, but would be subject to subpoena under section 11 of TSCA if they do not comply. This represents a change from the proposal which would have made all manufacturers, processors, and distributor* subject to the copy submission requirement Now, only those who actually have dealt with the chemical must report (except distributors). Many comments suggested ideas for limiting the persons subject to the rule and limiting the types of studies to be submitted. These ideas were: (1) Limit the copy submission requirement to past and present manufacturers, processors, and distributors of the chemicals selected by EPA since, in the commenters' view, these would obviously be the parties with the greatest interest in developing data, and thus the ones most likely to possess it EPA agrees and hat changed the initial reporting under the rule accordingly. However, EPA may later UCC 006752 Federal Register f Vol. 47, No. 171 / Thursday, September 2, 1382 / Rules and Regulations 38785 rsqntst any person. who is listed j naed only consult Its records not retired pursuant to f 718.7 as possessing a prior to December 31,1979, either for study, to submit that stady. studies or for answering the question of {2} Limit the copy submission whether It dealt with a chemical in the requirement of past manufacturers to past The more valuable, older studies those who base manufactured since . will likely have been preserved in 1905.1970,1975, orpresantly \ aurreat files, rather than being retired. In manufacture Instead of since 1960 es \ addition, searching long-retired files proposed. The commenters maintain \ could be vary costly; too costly for that these "cut-off" dates would tend to purchase of this rule. December 31,1979 reduce the volume of studies collected is the date on which potential and would maximise the quality of the respondents to this rule were put on studies being collected since, in the notice of the Agency's intention to commenters' view, older studies tend to require this reporting, and it is therefore be of less value. an appropriate data to define the limits EPA retained the reporting of the file search. requirements for past manufacturer* and (3) Limit the rule to persons who processors because they are Just as reported the chemicals for the Inventory. likely to have good studies as present This would reduce the company's manufacturers and processors. EPA burden in determining its responsibility proposes the January 1.1950 data under e section 0(d) rule merely to because persons who have dealt with checking the list of chemicals it reported the chemical and performed studies in for the Inventory, and would yield the the last thirty yean would have utilized higher quality data developed by the more advanced analytical techniques. manufacturer or processor. Thq Agency received comments Q*A did not adopt this suggestion for basically agreeing with EPA's view that two reasons. Complete reporting for the there ie a time In the pact beyond which Inventory was limited to manufacturers techniques were not so good as they are whereas section 8(d) also applies to now, However, commenters suggested processors. In addition, the implicit cut-off dates from 1985 to 1975. with assumption that only those who most commenters suggesting 1970 as a reported for the Inventory would have a cut-off date because they believe that fiat of their Inventory chemicals is not information more than tan years old valid. All manufacturers and processors may be outdated and of little value. of chemicals must know if the chemicals Commenters' agree that more they make are on the Inventory, whether advanced analytical techniques were they reported for the Inventory or not used after 1950, but they maintain that They must know, because they must most of the more sensitive detectors and submit a premanufacture notice to EPA techniques for gas chromatography, under section 5 of TSCA, before making atomic absorption spectroscopy, and or processing a chemical that is not on infra-red spectroscopy were developed the Inventory. during the last decade. (4) Decrease the burden of section 6(d) For instance, the late 1960`s saw the rulemaking and subsequent regulations first commerically available liquid by asking major manufacturers chromatography unit while the first gae voluntarily to submit studies. If chromatography unit with infra-red manufacturers refuse to do so, then the spectrophotography was not available Agency could proceed with section 8(d) until 1972. Also, many of the screening rulemaking, or go directly to section 4 testa used today, such as the Ames Test rulemaking. were developed during the last decade. EPA did not adopt this suggestion. The commenters were persuasive that Although some companies may submit thirty years is inappropriate and that a certain studies voluntarily, it is shorter time span would be appropriate. important that EPA receive all relevant Therefore, the final rule states the studies. Only a section 8(d) rule can period as ten yean prior to the effective ensure this. In addition, many date for reporting on a chemicaL This commenters stated that many studies will keep the ten-year period constant contain trade secret information which for the future. Holding to the 1950 data companies are very reluctant to submit would result in en ever-lengthening span voluntarily. as this rule is used in the future. (5) First require lists or titles of Moat of the concerns expressed about studies that have been performed by the long time span were concents about manufacturers or processors of the companies potentially having to search listed chemicals and then later request retired files either for studies or to find copies of selected studies. out whether the company had dealt with This suggestion was not adopted the chemical in the past To avoid this because insufficient information is problem of retired files, the Agency has contained in the titles of studies to give specified in the rule that a company e basis for study selection. (6) Limit initial reporting to key studies relevant to specified effects [seek as those tbe ITC recommends be tested) in order to produce studies most valuable to risk assessment and to reduoe reporting burdens and EPA's.. review burden. This suggestion was not sdoptedr EPA plans to investigate a full range of properties and effects of the listed chemicals. Effects of a substance are not discrete Items, unrelated to one another. On the contrary, certain effects and properties are predictive of other effects and properties. For Instance, fate and persistence studies will help in predicting environmental effects. Acute toxicity studies generally provide data to determine the median lethal don (LD50) of a chemical substance (Us . relative toxidty), but also may provide data to Judge its modeft) of action, to determine its specific toxic effects) on target organs and functions, and to determine the existence end extent of species differences in sensitivity to a chemicaL Acute effects studies designed to measure potential ecological effects are especially valuable since there is comparatively less information in this field than in othere. Also, the submission of acute effects studies will be used to determine the need for and character of acute effects testing rules. A broad range of studies is well recognized as necessary to Judge the adverse effects of a chemical substance. For example, the Organization lor - Economic Cooperation and Development (OECD) has developed a base set of recommended teats containing a range of tests at physical and chemical properties and toxicity for assessing the hazards at chemicals. It has selected many physical and chemical properties that, in its view, constitute "information for degradation, accumulation and even noxious effocta assessment * * * . For example, the shape of a particle can. in Itself, be indicative of its carcinogenic nature (e^ asbestos fibers) end the partition coefficient is indicative of likely accumulation in lipid tissues." OECD Chemicals Testing Programme, Expert Group. Physical Chemistry, Pinal Report VoL L p. 41. In addition to physical ad chemical properties, the OECD has also included many acute, subacute, and chronic teste in the base set of tests. (7) Limit the chemicals subject to the rule to "high priority" chemicals such as ITC chemicals to match exactly tbe ITC recommendations and reduoe the reporting burden. EPA did not adopt this suggestion; The chemicals recommended by the ITC may be in fact the majority group on the UCC 006753 38786 Federal Register / Vol. 47. No. 171 / Thursday, September 2, 1982 / Rules and Regulations rule, but they are not the only chemicals on which EPA will need studies. The hazards of other cbemialt are and will be under investigation. B. Requirements for Submitting Lists of Studies The final rule adopts the proposed requirement that only current manufacturers and processors of listed chemicals and those who propose to manufacture or process these chemicals must submit lists of studies. Several comments objected to listing records kept on employees exposed to chemicals. They assert that record systems and data do not constitute a study unless an intention to correlate certain data to evaluate results and reach conclusions is declared A record listing requirement would move the scope of the requirements into the realm of conjecture, and render the proposal, in this respect at least, impracticable, even if the thrust of this listing requirement falls within TSCA's authority. Quite simply, according to the comments, there is no way to determine to which particular chemicals any given employee might be exposed Interpreted literally, this requirement would encompass the records for all employees, a result surely not intended by the EPA. The Agency agrees and has modified die proposed listing requirements. The studies to be lilted do not include record systems. Persons will not have to list medical record systems or daily or routine monitoring records. These types of data could constitute underlying data for an epidemiological study for example, but are not by themselves treated as studies. Other commenters asserted that protocols for ongoing studies should not be submitted, as the proposed rule would have required, since protocols are not health and safety studies and contribute no relevant health and safety Information regarding chemicals. EPA has adopted the limitations suggested. Copies of protocols do not have to be submitted since they will usually be described in the study eventually reported. Some comments objected to listing, ongoing studies. They maintained that section 8(d) applies only to completed studies. EPA disagrees with this comment Section 8(d) authorizes listing of a study "conducted or initiated by or for" a company. EPA may require listing once s study has begun because it has been "initiated" within the meaning of the statute. A few comments questioned the need for listing ongoing studies and for submitting preliminary reports, if requested, when an ongoing study is listed. They asserted that partial and Incomplete data can be extremely misleading. Also, they said a scientist should not be required to disclose the results of his research until the scientist is satisfied with the accuracy, reliability, and scientific significance of the data. The Agency disagrees. It requires a list of ongoing health and safety studies to tailor testing rales to fill real gaps in knowledge. If industry has started enough research of a particular type, the Agency could exclude that type of testing from a testing rule or delay it until the test data are available to the Agency. For chemicals for which testing is not contemplated, the submission of lists of ongoing studies will help the Agency determine the scope of possible control regulations. It for example, the Agency is considering control of a particular use of a substance, the knowledge that a person is testing that substance to determine its effects or potential for exposure to man or the environment would be valuable information. The Agency will not routinely require preliminary reports to be submitted. However, under procedures stated in i 718.8, EPA may ask for the submission of preliminary reports when necessary. The Agency understands the concern a scientist might have about releasing preliminary data. However, sometimes it is necessary to track the progress of a long-term animal study, for example, so that the Agency can order its assessment priorities- It is far more costeffective to monitor a study industry is performing than to propose a testing rule or take regulatory action that might be found to be unnecessary when the final teat results are reported. IV. Studies Not Subject To Mandatory Reporting A. Exemptions for Studies ofMixtures The proposed rule provided four exceptions to the reporting requirements. Persons did not have to submit (1} Copies or lists of published studies; (2) copies of studies previously submitted to Federal agencies with no claims of confidentiality; (3) copies of studies conducted by other persons subject to the rule; or (4) copies or lists of studies of mixtures containing small amounts of listed substances when the studies clearly did not reflect effects of the listed substances. Comments addressing items (1) through (3) above, and EPA's responses, appear in "General Comments on the Proposed Section 8(d) Rule." The exemption for reporting mixture studies (number 4 above) generated the greatest number of comments. The commenters were almost evenly divided on whether the proposed exemption or a modified version of it should appear in the final rule. Some comments stressed the difficulty of predicting the effects of a single component of a mixture from _. results obtained from testing the entire mixture. Therefore, they suggested the Agency should not require the submission of any mixture studies. Other comments suggested that the Agency fine-tune the exemption by requiring only submittal of a study on a mixture containing a listed chemical when the study was undertaken for the express purpose of determining the effects of the listed chemical or when data in the study were originally aggregated and analyzed in a manner that directly and specifically relates to such effects. Weighing all of the above, EPA decided to approach the problem differently. As before, only studies of mixtures in which a listed chemical is known to be present will be submitted, but in place of the proposed exemption, the Agency has provided exemptions for (1) Physical and chemical properties of mixtures; (2) Certain types of acute studies on mixtures: and (3) Certain aggregations of monitoring data on mixtures. See { 718.11 (e) through (h) of the rule for the particular studies that are not subject to reporting. The remaining studies to be reported must be reported regardless of the submitter's view of whether tbe studies reflect effects of the pertinent substance. EPA will make this judgment By expanding the fiat of studies that do not have to be submitted and removing the review necessary to determine which mixture studies sliould be submitted, the reporting burden on persons will be significantly reduced. B. "Substance" Versus "Mixture" In the final rule {( TialS), EPA clarifies bow certain preparations of substances should be treated. For example, one commenter Indicated that ha considered an aqueous solution of a substance to be a mixture. Since one often puts a substance into aqueous solution before testing it for biological activity, the commenter's view could result in many tests being reported as tests of mixtures. This would be an absurd result in the context of this rule. Studies of the following preparations of a chemical substance must be reported as studies of the chemical substance itself, not os studies of mixtures containing the substance: UCC 006754 Federal Register / Vol. 47, No. 171 / Thnraday, September 2. 1982 / Rules and Regulations 38787 (1) The chemical substance in aqueous solution. (2) The chemical substance containing a imall amount of an additive, auch aa a stabilizer, emulsifier, or other chemicals added for purpose* of maintaining the integrity or physical form of die substance. (3) The chemical substance at any grade of purity. Studies of these preparations of substances are classified for reporting as studies of the substance. EPA does not, and need not, at this time reach the issue of whether these preparations are defined as mixtures or chemical substances under TSCA. V. File Search Because of the considerable confusion on the part of coriunentera regarding the file search required by the proposed rale, the final rale contains a provision describing the file search required. Persons can satisfy the requirements of this ryle if they limit their search for information to files in which such information is expected to be found in the ordinary course of their business, and the files of employees whose assigned duty ia to adviae the company on the health and environmental effects of chemicals. The actual mechanics of the search can be approached in a number of ways depending on the size of the company and the type of chemicals for which studies will be submitted. EPA Includes the following discussion to convey how it believes a satisfactory search might reasonably be conducted with the least expenditure of resource*. The Agency is not saying that this la how companies must search. Far small to medium size companies that believe they are subject to the rale and have few studies of any ldnd, it may be more coat effective to scan the titles of the studies they possess and then check to see if the chemical studied is on the list of chemicals subject to the rale. EPA's experience has been that smaller companies submit few studies and will find it easin' to match studies against the chemical list Large companies might use the seme approach depending on how their file* of studies are Indexed. Alternatively, they might determine the chemicals they handle(d) then search for studies. The Agency expects the search for physical and chemical properties to be minimal for all companies because of the very limited number of properties that are subject to the rale. Also, the Agency expects that companies will have special reference file for the moat standard properties such as solubility or vapor preasure. For other, special purpose, properties, such as octanol/ association that contracts for testing wstn partition coefficients and (including trade associations such aa the degradation properties, the company Chemical Industry Institute of will not be determining these on a Toxicology). EPA considers this to be a routine basis and should be able to reasonable change. Since only those check with one or two key personnel to studies under a company** control and see if these studies were performed. sponsorship are covered, there will be Companies possibly subject to As no need for a search; the report to EPA rale because a listed substance is a will be made when the study is ordered component of a mixture should be able to be done. In addition, EPA has limited to examine the mixture studierthey this continuing reporting requirement to possess to see if any components of the chronic studies; long- and short-term mixture studied are an the section 8(d) tests of mutagenicity, carcinogenicity, or chemical list. Since moet of the studies normally performed on mixtures are exempted by the rule, moet companies will only have to examine a handful of subchrofrfc and chronic studies on mixtures to determine which studies should be submitted. teratogenicity; and the biological and environmental fate tests listed in I 716.10(h) through (j). Another concern of the comments was that tha five-year period for reporting completion of ongoing studies or initiation of new ones is too long, VL Reporting Schedule and Sunset especially since EPA must act on Provision chemicals recommended by tha ITC Persons must submit lists and ooples of studies no later than sixty days after the effective date of promulgation of the list of chemcfal substances and mixtures in 1710.17. The rale also provides for extending the submission deadline for a reasonable period, if a company requests such an extension because of long file searches. Because they assumed a very extensive file search was required, many commenters suggested that sixty days was insufficient time to comply with the rule. EPA ia retaining the proposed schedule because ft has made significant changes to reduce the search burden. The scope of this final rale ia less than that of the previous section - within twelve months. The Agency believes that a multiyear period ia necessary. Tbs action required within twelve months is to initiate rulemaking, or give EPA's reasons for not doing so. Promulgating a test rule or entering into a voluntary testing agreement will require consideration over a longer periodjuring whichjiew datafit me initiation ofnew stadias * could affect EPA's final action. Even after a test rule is promulgated or a voluntary testing agreement is reached, new data on substances under test will be important in tha Agency's evaluation of tim chemical subsequent to testing and could contribute to a dedalon whether control action for the chemical 8(d) rule under which[companies, fr 7 f is indicated. However, to balance EPA's reported in-lOTrsince many exemptions needs against the burden of this to the required studies and toe requirement. EPA has decided to responsibilities of respondents have maintain a multiyear approach but to been mode. No company requested an limit It to three yean. EPA believes that extension of time for reporting under the this represents a minimal reporting rule's sixty-day schedule. Based on the burden since the only studies covered experience, and because of the by this requirement would be presently reduced scope of this rale, the Agency ongoing studies which are completed believes that sixty days is an and studies initiated during toe three- appropriate period. year period. Also, the rule now allows As proposed, the rale would have the Assistant Administrator to terminate required that persons subject to the Hat the requirement for reporting about a submission requirement inform EPA of particular chemical If he detides that any study initiated during the five years further reporting is not needed. prior to the sunset date. Comments considered this to be too burdensome VH. iHaWty since it would require them to search continuously for all new studies. EPA EPA is aware of the need to protect confidential business information. agrees that toe proposed provision was Several commenters suggested that the too broad. The Agency has changed toe regulations should contain a specific requirement Under the final rule, these statement about the means EPA would persons will oe responsible only for informing EPA of studies initiated by or for them, rather them of any new study. use to protect toe confidentiality of information in toe unedited copy of a study. This includes studies directly contracted The TSCA Confidential Business for by the company or studies sponsored Information Securuty Manual contains through a company's membership in an the procedures for physically UCC 006755 38788 Federal Register / Vol. 47, No. 171 / Thursday, September 2. 1982 / Rules and Regulations safeguarding confidential business Information submitted under TSCA. (The manual is available from the OPTS Industry Assistance Office--see FOR FURTHER INFORMATION CONTACT.) EPA will share confidential information with contractors, other EPA offices, and other Federal agencies only in accordance with these procedures. In addition, all Information claimedas confidential is subject to the legal procedures in 40 CFR Part 2 with respect to disclosure by EPA. A person submitting a health and safety study may claim all or part of (be study confidential However, health and safety information about a chemical that has been offered for commercial distribution or is subject to testing under section 4 or notice under section 5 can be withheld from disclosure only to the extent that disclosure would reveal (1) processing information and (2) percent composition of mixtures, or contains information the disclosure of which would dearly be an unwarranted invasion of personal privacy (such as individual medical records), as provided in 5 U.S.C 552(b)(8). Any daims of confidentiality must be made at the time of submission, at provided in 40 CFR 2.203(a)(2) and in the manner specified in I 718.18 of this regulation. This rule requires submission of two copies of studies containing confidential material--one copy indicating what data are daimed as confidential and one copy without the confidential information. EPA will presumptively consider failure to submit the second copy as a waiver of the confidentiality claim. However. EPA will notify respondents who daim parts of studies confidential that they did not submit the required second copy. This provision affords persons the opportunity to correct errors within 30 days. Commenters raised a number of Issues concerning specific provisions of the proposed regulation that detail the methods for submitting confidential information. One assertion was that submitters should not be burdened with "up front" substantiation for daims of confidentiality, and that such substantiation should be required only if EPA receives a Freedom of Information Act (FOIA) request for the information. The Agency will not require "up front" substantiation. The language of } 718.18(c) has dropped the requirement that the basis of the daim be "explicitly" explained at the time of submission. The claim must still be explained briefly. However, this explanation should merely be a simple statement indicating that the reason for the daim is, for example, related to mixture proportion or process 'information, or that the information is dearly irrelevant to the health and safety study. EPA does not expect detailed substantiation of confidentiality claims at the time the study is submitted. The Agency believes that this simple statement is justified, because EPA needs some understanding of the claim to have a basis for initial denial or granting of FOIA requests end to protect the information. Another auggestion was that failure to provide a nonconfidential second copy of a study for which daims are made should not be considered a presumptive waiver of the claim. The commenter asserted that the daim to a trade secret It a property right and cannot be taken away by the operation of a presumption. In their view, once the daim is made, it must stand unless a disclosure request is made and FOIA prindples require that it be granted. EPA will not place confidential information in the public file automatically if a second copy is not received. The Agency will notify the respondent that it has not received a second copy. This will allow the company to correct the situation. Another commenter claimed that the 20-day grace period for correcting incomplete confidentiality submissions does not allow the respondent suffiden! time to respond. The rule 1ms been changed to extend the proposed 20-day grace period to 30 days. This should bis adequate for such a straightforward response, even given mail delays, because the only step needed is to provide a second, nonconfidential copy for the public file. A final specific comment was that the Agency must not allow confidentiality daims for submitted health and safety studies- To do so. is. in the commenter'* view, a direct illegal contradiction of section 14(b) which exempts the results of health and safety studies from such daims. EPA disagrees that it should not allow confidentiality daims. Respondents may daim any information as confidential; however, the only information which the Agency may actually keep confidential is listed in f 718.16(c). VIIL Economic Impact EPA estimates that the total cost to industry of submitting lists and copies of health and safety studies under the present rule is approximately $537,000. The major cost to a firm will be the cost of a file search to determine what health and safety studies it possesses. This cost will, of course, vary directly with the size of the firm, assuming that larger firms have more files at more locations which must be accessed. Once the studies are located, the remaining compliance costs involve copying and processing the studies, making lists of studies which are in progress or not in the possession of the respondent, and reviewing the studies for confidential information. The Agency's cost estimates are based on the cost to an ~ * average firm. EPA recognizes that actual costs will be larger or smaller for larger or smaller firms. Each of these costs is tabulated below. Tata/ .11~. ' I Ongoing - --. mxtx 7,000 1*1,000 - 7.000 2*000 10*000 77,000 07.000 This represents a cost of approximately $2,000 to $4,000 per chemicaL When the Agency adds to the Ust of chemicals subject to the rule, these cost per chemical estimates can be used to determine the cost of the additional reporting. If the studies submitted allow EPA to eliminate even one potential section 4 mandated teat on a subject chemical the coat avoided could exceed the total coat of this rule. For example, EPA estimates that It will cost industry from $700,000 to $1,300,000 to perform the proposed testing (see 45 FR 48557) for chloromethane and up to $4,900,000 for chlorobenzenes (see 45 FR 48557). The Agency received many comments suggesting that its original estimate of $410,000 total cost was too low. The comments pointed to many features of the proposed rule that they believed would cause much greater burdens than the Agency had assumed. However, only a few comments actually gave EPA estimates of the time or money they would expend in complying with the proposal. For example, the Chemical Manufacturers Association suggested from a survey of thirteen of its members that the cost per company would be $400 to $10,000 per chemical, but this range estimate was not accompanied by data to indicate how the figures were generated. The following is a list of the most burdensome features of the proposal as dted by comments. For each feature, a description follows for the changes made in the final rule to reduce the burden. (1) One large burden commenters perceived was in searching for routine monitoring records and for medical UCC 006756 Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations 38789 records. The commenten read the of their business, and the files of those most of the comments received from proposal to require submission of these employees whose assigned duty is to companies on the proposed rule were data. However. EPA has made it clear in advise the company about health and from companies in those industries, the final rule that these records are not environmental effects of chemicals. which EPA believes is an indicator of to be submitted as studies. The Agency (5) Comments have requested that the respondent population for the final may request them in the future, but only studies on research and development rule. Third. EPA believes that almost all if they are underlying data to a study. chemicals be exempted. They requested (2) The proposed requirement to the exemption for a number of reasons, submit all studies on mixtures one being that these studies may be in a containing a listed substance would different set of files at different have caused several problems, locations than other studies. EPA has according to many comments. The not fully exempted these studies (see R problems would have come In searching It D Chemicals) because, as previously through records to determine whether a discussed In this preamble, the Agency listed substance could be present in a does not believe that the fact that a studied mixture and in then deciding . studied chemical has been in research whether the Hated substance was and development is relevant to the value responsible for whatever effect the of the etudy. However, by better study showed. defining the file searches required for The Agency has substantially changed compliance with the rule the Agency has the requirements for submitting studies reduced the burden of searching for such on mixtures. It has excluded most acute studies. studies from the requirement; it has (6} The report's impact analysis for of the studies performed on the listed substances are initiated by the manufacturers and primary processors of the substances, which is the reason EPA exempted distributors from reporting. These companies are heavily concentrated in the chemical allied products, and petroleum refining industries. Furthermore, the changes, exemptions, and limited file search prescribed in this rule should eliminate the possibility of a substantial burden of unavailing searches. (8) The analysis accompanying the proposal did not consider the ongoing excluded all physical/chemical the proposal did not include the burden cost of reviewing newly completed parties of mixtures; and the Agency to a company to familiarize itself with studies during the multiyear follow-up excluded studies of mixtures that the rule. Commenters remarked on this, period. contain the listed chemical only as an and the Agency has included this item in EPA does not believe that Impurity. In addition, the Agency has removed the requirement for respondents to decide whether the effect the final analysts. (7) The report's impact analysis far the proposal did not consider the cost of consideration of ongoing studies poses a substantial burden that would appreciably alter tbe report's impact studied was caused by the listed substance--EPA will make that Judgment These changes should cut the cost of submitting mixture studies substantially. The changes mean that companies can go directly to their copies of studies on mixtures to see if a listed chemical was in a mixture tested. The number of studies to be looked at has been much reduced. And, most importantly, companies will not have to search records to find out what impurities may have been present in the studied mixture. (3) The proposal would have required companies who may never have dealt with a chemical to submit studies on it if they had then. EPA has removed this burden by changing the requirements to file searches which must be conducted by firms which will not actually find submittable studies in their file. Commenten suggested EPA account for these coats. In the first analysis, EPA attempted to base coat estimates upon the prior experience of firms which reported for the original section 8(d) rule. These data did not reflect the experience of firms which conducted futile file searches, and did not report. The Agency believes that for die purposes of a report impact analysis, the previous experience of the prior section 8(d) rule is die firmest estimate that the Agency can utilize. However, EPA has now attempted to estimate coats for those companies that handle the listed substances, but have analysis. Since firms would review newly completed studies for their effects regardless of this rale, no file retrieval costs associated with other health and safety studies would be incurred for these new ones. (9) Comments criticized confirmed reliance on the assumption that 2.8 firms will respond per chemical which was based on EPA'* experience with the first section 8(d) rule, even though the additional chemicals subject to the rule are qualitatively different (high volume, extremely prevalent) than the chemicals subject to the first section 8(d) rule. EPA's continued reliance on data from the first section 8(d) rule is valid. There is no real qualitative!^difference in the apply to those who have manufactured no studies to report. The Agency did this chemicals subject to tbe original or or processed or have proposed to by searching the TSCA Inventory to present section 8(d) rules--many of the manufacture or process the chemical. determine the number of companies that chemicals subject to both rules are high Moreover, the Agency has said that - reported the listed substances and then volume and extremely prevalent companies can determine their multiplying this number by a factor of Further, approximately 6Jt firms association with the chemical by looking three to account for processors ami reported for the Inventory on chemicals at their current files. This win alleviate a that were listed on the first section 8(d) concern expressed by companies whose Although some commenten indicated rule (this figure represents the average ownership or activities have changed that the scope of the rule extends number of firms or companies, not the and whose records have been retired. beyond the "chemical industry" and average number of sites), whereas only (4) Perhaps the greatest burden cited wou^therefore increase the potential 2.8 firms responded per chemical for the was that of potentially searching every number of processon of the listed original section 8(d) rule. For the company file for studies or references to substances beyond our estimate, EPA subsequent ITC-recommended studies. The proposal was broadly believes that its estimates no o chemicals on tha proposed rule, 1.1 firms worded in this respect The final rule respondents is proper for the following reported for tbe Inventory. An average contains a section describing the much reasons. Pint over 85 percent of the of Z2 firms reported for the Inventory on more limited search that wfil be enough companies that reported for the first chemicals selected by the EPA on the to comply with the rule. Companies will section 8(d) rule were concentrated in proposed rule. This indicated that the comply if they search the files where the chemical, allied products, and Agency's reliance on the ZB figure studies are kept in the ordinary course petroleum refining industries. Second, would actually tend to overstate the UCC 006757 ..-yo.cM , ui. */, wo. 171 / Thursday, September 2, 1982 / Rule# and Regulations number of expected respondents for the present rule. (10) Comments were also concerned about the categories of chemicals in the rule. They specifically asked for better definitions of the categories or for lists of the chemical In the categories for which EPA wants studies. Because of chemical nomenclature complexities, the commentera suggested thst the burden of deciding whether a given chemical should be counted in or out could be great EPA has eliminated one of the more troublesome categories from the listacrylic acid and methylacrylic add and their esters. In addition, the Agency bas given better descriptions and more examplee to define the categories. EPA believes that these steps, plus the fact that the categories now on the rule are ones that companies have become familiar with in following ITC ' recommendations for testing, should reduce the dted burden. A company that has a question about whether a particular chemical it included in a category should call the information number gives at the beginning of fills notice. EPA staff will be available to return thete calls and answer questions. The basic elements EPA has induded hi the final Reports Impact Analysis ere: (a) Corporate rale review--2 hours at $50 per hour. (b) Corporate, identification of pertinent files--3 hours at $50 per hour. (c) File search el plant site--0 hours at $30 per hour. (d) Listing study titles--1 hour at $19 per hour. - (e) Photocopying per study--X hour at $15 per hour. (Q Final review before submission--1 hour at $50 per hour. EPA's estimate of total cost of the rule uses the above figures end assumes that $91 firms will perform an Initial review; 447 firms will submit 3.784 reports of 50 pages each; and each firm has, on a weighted average, 14 plant sites. The corporate rule review step was suggested by commenters, as was the corporate identification of locations to be searched. EPA has increased the hourly costs of managerial review and file searches by $10 each from previous estimates, and increased the file search time per site from four to six hours. These new estimates are based upon suggestions from commenten and the changes EPA has made to rule requirements. One caveat that must be kept in-mind la that these are average costs. Individual firms may experience neater or lesser costs depending on their size. EPA received comment that one hour for final review before submission would not be enough to accommodate decisions on aonfidentiality. The Agency's estimate of an average of one hour review per study is reasonable. EPA does not expect that a company should have to scrutinize a study for confidential information just before it is submitted to EPA. Confidential information in a study should already have been identified as such by the company. For example, to get e court to prevent disclosure of confidential information, a company must be able to show that the information was given special treatment by the company, Le,, marked confidential or kept in limited access files. Therefore, the Agency believes that most of the information in a study that Is confidential will have been previously identified as such by the company, and it should not be necessary to check with virtually every department of the company, es some commenten suggested, to check whether each data element is. confidential. DC Public Record EPA has established a public record (docket number OPTS-B4003A] for this rulemaking document, which along with a complete index is available for inspection In the OPTS Reading Room. Rm. E-107,401M Street SW, Washington, DC 20480, from &00 a-m. to 4.-00 pjn. Monday through Friday, except legal holiday*. This record includes basic information considered by the Agency in developing this rule. Following is a'list of die documents which constitute the record for this rulemaking. Public comments on die proposed rale ere not individually listed, but will be available upon request in the OPTS reading room. EPA requests that It be notified of any additions or deletions to this record within the next 30 days. (1) Health and Safety Study Reporting Regulations, July 18, 1378, Public Record, Docket No. 064001. (2) Manufacturing Chemists Association-- Petition under section 21 of TSCA, September 12.1978. (3) Denial of Citizens' Petition. 3 FR 5872458727. (4) The entire docket in Dow Chemical Company v. United States Environmental Protection Agency, et aL Docket No. 78-2203 (3rd Cir.). (5) Revocation of Rule. 44 PR BOW. (6) Reporta Impact Anaiysia of this rulemaking. (7) All comments on this rule, including any comments received from the Office of Management and Budget during Paperwork Reduction Act review. (0) General Comments on the Proposed Section 8(d) Rule. (9) All relevant support documents and studies. (10) Records of aO communications between EPA personnel and person* outside the Agency pertaining to the development of this rule. (This does not Indude any inter- or intra-agency memoranda unless specifically noted in the index of the rulemaking record.) (11) Minutes, summaries, or transcripts of any public meeting* held to develop this tula. (12) Any factual information considered by the Agency In developing the rule. X. Regulatory Assessment Requirements Executive Order 12291 Under Executive Order 12291, EPA must judge whether regulation is "major" and therefore requires a Regulatory Impact Analysis. EPA has determined that this regulation is not major because it does not have an effect of $100 million or more on the economy. It Is expected to have a one-time cost of about $725 thousand. It does not have a significant affect on competition, or costs or prices. ; This regulation was submitted to the Office of Management and Budget for review as required by Executive Order 12291. Regulatory FlexibilityAct Since this rale was proposed before the effective date of the Regulatory Flexibility Act. 5 U.S.C. 801 at seq., the Act's requirements do not apply. However, based on the Agency's experience with a previous section 8(d) rule, it expects that only about 1 percent of die respondents will have groat sales of less than 20 million dollars. Paperwork Reduction Act Information collection requirements contained in this regulation (f | 7184 and 718.7) have been approved by the Office of Management end Budget (OMBj under the provisions of the Paperwork Reduction Act of 1980 U.S.C. 3501 et aaq. and have been assigned OMB Control Number 2070-0004. This rule requires manufacturers and processors of 40 chemicals and categories of chemicals to submit unpublished health and safety studies relating to these chemicals. The studies to be submitted will be used by EPA o-'evaluating health and environmental effects of chemicals for purposes of assessing risks associated with the chemicals, as well as in determining whether the chemicals should be included In testing rules issued under section 4 of TSCA, Lists of Subjects In 48 CFR Part 71$ Chemicals, Health and safety, Environmental protection. Hazardous materials, Recordkeeping and reporting. UCC 006758 Federal Register / VoL 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations 38791 Dated: August 19.1962. (a) "Byproduct" means a chemical Jobs E. Daniel substance produced without a separate ActingAdminiMtroior, commercial intent during the Therefore, Chapter I of Title 40 of the Code of Federal Regulations is amended by adding a new part Tie consisting at this time of Subpart A to read aa follows: manufacture, processing, use, or disposal of another chemical substance(s) or mixturefs). (b) "Co-product" means a chemical substance produced for a commercial purpose during the manufacture, PART 716--HEALTH AND SAFETY DATA REPORTING processing, use, or disposal of another chemical substancefs) or mixturefa). (c) "Copy of study" means the written Suripert A--General Provision* Sac. 718.1 716J HU 718tl 7167 7164 Scope and compliance. Definitions. Overview of subpart requirements. Submission ofcopies of studies. Submission of lists of studies. EPA requests for submission of further presentation of the purpose end methodology of a study and its results. (d) "EPA" means the United States f Environmental Protection .Agency, (e) "Health end safety study" or "study" means any study of any effect of a chemical substance or mixture on health or the environment or on both, information. including underlying date end TIM How to report an substances and epidemiological studies, studies of mixtures. occupational exposure to a chemical 718.10 Reporting physical and chemical properties. nui Exemptions to reporting requirements. 716.12 File search. 718.14 Reporting schedule. 718.18 Confidentiality elsims 716.17 Snbetances and designated mixtures to wtdcfa this subpart applies. substance or mixture, toxicological, clinical, and ecological or other studies of a chemical substance or mixture, and any test performed under TSCA. (1) It is Intended that the term "health and safety study" be Interpreted broadly. Not only is information which arises as a result of a formal, disciplined 716.18 Additions to lists of substances and study included, but other information designated mixtures to which this subpert applies. 718.19 Sunset provision. relating to the effects of a chemical substance or mixture on health or the environment is also included. Any data Authority: Sec. 8(d). Pub. L. 94-400, SUL 2028 (15 UAC naif)). that bear on the effects of a chemical substance on health or the environment Subpart A--General ProvMont would be included. Chemical identity is part of, or underlying data, to. a health |716.t Scope and compluncUL (a) This Subpart sets'forth _____ _ requirements for the submission of lists and copies of health and safety studies on chemical substance* and mixtures selected for priority consideration for testing rules under section 4(a) of the Toxic Substances Control Act (TSCA) and on other chemical substances and mixtures for which EPA requires health and safety information in fulfilling the purposes of TSCA. and safety study. (21 Examples are; (11 Long- and short-term tests of mutagenicity, carcinogenicity, or teratogenicity; date on behavioral disorders; derma toxicity: pharmacological effects; mammalian absorption, distribution, metabolism, and excretion; cumulative, additive, and synergistic effects; and acute, subchronic, end chronic effects. (ii| Tests for ecological or other environmental effects on invertebrates, (b) Section 15(3) of TSCA makes it fish, or other animals, and plants. unlawful for any person to fail or refuse Including; acute toxicity tests, chronic to submit information required under toxicity tests, critical life stage tests, this Subpart. Section 16 provides that e behavioral tests, algal growth tests, seed violation of section 15 renders a person germination te* p1--* liable to the United States for e civil damage tests, microbial function tests, penalty and possible criminal bioconcentfation or bioaccumulation . prosecution. Under section 17. the tests, and model ecosystem (microcosm) district courts of the United States have studies. jurisdiction to restrain any violation of Util Assessments of human and section 15. environmental exposure. Including (7162 Definitions. workplace exposure, and impacts of a particular chemical substance or The definitions in section 3 of TSCA mixture on the environment including apply to this SubparL In addition, the surveys, tests and studies jaf: Biological, following definitions are provided for photochemical, and chemical the purposes of this Subpart: degradation: structure/activity relationship*; air, water, and soil Ginsport biomagnification and bioconcentratlom and chemical and physical properties. e.g,, boiling point vapor pressure, evaporation rates from soil and water, octanol/water partition coefficient, and wa ter solubility. ffv) Monitoring data, when they have been aggregatetfand analyzed to measure fEe'exposure of humans or the environment to a chemical substance or mixture. (f) "Importer" means any person who imports a chemical substance, including a chemical substance as a part of a mixture or article, into the customs territory of the United States and. includes the person primarily liable for the payment of any duties on the merchandise or an, authorized agent acting on his behalf (as defined in IB CFR 1.11). Importer also includes, as appropriate: (1) The consignee. (2) The Importer of record. (3) The actual owner, if an actual owner's declaration and superseding bond has been filed in accordance with IB CFR 1412a (4) The transferee, if the right to draw merchandise in a bonded warehouse bat been tranfened in accordance with Subpert C of 18 CFR Part 144. Por the purpose of this definition, the customs territory of the United States consists of the 50 States, Puerto Rico, and the District of Columbia. (g) "Impurity" means s chemical substance which is unintentionally present with another chemical substance. (h) "Manufacture" and "Process" mean manufacture or process for commercial purposes. (i) "Manufacture for commercial purposes" means: (1) To import produce, or manufacture with the purpose of obtaining an Immediate or eventual commercial advantage for the manufacturer, and includes, among other things, such "manufacture" of any amount of a chemical substance or mixture: (1) For commercial distribution, including for test marketing. (if) For use by the manufacturer, including use for product research and development or es an intermediate. (2) The term applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture, including both byproducts and coproducts that are separated from that other substance or mixture and impurities that remain in that substance or mixture. Byproducts and impurities may not in themselves have commercial UCC 006759 38792 Federal Register / Voi. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations slue. They are nonetheless produced must be submitted within 60 days after (716.8 Submission of copies ofetudfoe. for the purpose of obtaining a the addition of the substance or (a) (1) Except as provided in {( 716.10 commercial advantage since they are designated mixture to ( 716,17. and 716.11. person* must send to EPA part of the manufacture of a chemical (ii) Under { 716.7 submit a list of copies of any health and safety studies product for a commercial purpose. studies that are ongoing when the in their possession for the substances or (j) "Parson" Includes any individual. substance or designated mixture is designated mixtures listed in f 716.17. Arm. company, corporation. Joint- added to | 716.17. The list must be venture, partnership, sole proprietorship, submitted within 60 days after the Persons arejsaponsibla for submitting copies an only me substances or association, or any other business addition of the substance or designated designated mixtures which they have entity, any State or political subdivision thereof any municipality, any Interstate body, and any department agency, or instrumentality of the Federal mixture to ( 716.17 and copies of such studies must be submitted within 30 days of their completion under i 718.14. (ill) Inform EPA within 30 days of any manufactured or processed`07 Proposed to manufacture or process (including as known byproducts) within the ten yean preceding the effective date for reporting government study Initiated by or for him after the on the substances or designated (k) "Process for commercial purposes" initial 60 day reporting period and mixtures. Persons who list studies as means the preparation of a chemical submit a copy of the study when it ia ongoing under f 716.7(a)(1) must submit substance or mixture, after its completed. Tnla requirement continues them when they are completed. manufacture, for distribution in until the sunset date specified In (2) Underlying data, such at medical | I [ commerce with the purpose of obtaining an immediate or eventual commercial advantage for the processor. Processing of any amount of a chemical substance or mixture is included. If a chemical i 710.10; It applies not only to persona who manufacture or process a substance or designated mixture when it ia added to the list but also to persons who begin to manufacture or process, or propose to or health records, individual files, lab notebooks, and daily monitoring records supporting studies, do not have to be submitted initially. I5PA may request underlying data 111167 under 1716JL substance or mixture containing impurities Is'processed for commercial purposes, then those impurities are also processed for commercial purposes. (l) "Propose to manufacture, process, or distribute" meant that a person has made a management decision to commit financial resources toward the manufacture, processing, or distribution of a chemical substance or mixture. (m) "Substance" meant "chemical substance" as defined at taction 3(2)(A) of TSCA. 15 U.S.C 2802(2)(A). (n) "TSCA" means the Toxic Substances Control Act 15 U.S.C. 2801 etseq. do so at any time prior to the (unset (b) Submissions under paragraph (a) date. of this section must be indexed by (2) A person who ia not covered under chemical name. Including CAS number if paragraph (bXlJ of this section, but has known, and must be accompanied by a manufactured or processed a substance cover letter containing the name, job or designated mixture listed in | 716.17, title, address and telephone number of or has proposed to do so, anytime In the the submitting official, and the name preceding tan yean, must submit copies and address of tha manufacturing or of studies in hit possession on the processing establishment qn whose substance or designated mixture within behalf the submission is made. In the 60 daye of when it is added to i 716.17. cover letter, respondents must identify (c) Studies to be reported. In gmetaL/^ any impurity or additive known to have studies, as defined at f 718J(rfthBt ^ been present in the substance aa studied unpublished are reportable, La- must be unless its presence is specifically noted submitted or listed, for any substance or in the study itself. designated mixture listed in 1716.17. - (c) Copies of health and safety studies 1718,4 Overview of subpart requirements. However, this requirement has and the accompanying cover letter must This section highlights basic limitations according to the nature of tha be submitted, preferably by certified requirements. Por additional procedure* material studied, so that--(1) All studies mail, to: U.S. Environmental Protection and qualifications, refer to pertinent of substances and designated mixtures Agency. TSCA-8D1. P.O. Box 2060. - individual sections. are reportable. However, in the case of Rockville, Maryland 20652. ia) Adequate file search for compliance with this subpart Persons physical and chemical properties, only those studies Bated in 1716.10 must be (718.7 Submission of Beta trt studies. are not required to search any records submitted. (a) Except as provided in (( 716.10 retired prior to December 31.1879 for (2) Studies of mixtures known to and 716,11. persons must send the lists information to comply with this enbpart contain substances or designated described in paragraphs (a) (1) and (2) of In addition, the scope of a company's mixtures listed in 1716.17 are reportable this section to EPA for each of the responsibility to search records 1a except for studies of physical and substances or designated mixtures fisted limited to records in which it ordinarily chemical properties and the studies in ( 716.17 which they manufacture or keeps the required information and to exempted at i 716.11(1) (1) through (Bf. process or propose to manufacture or records kept by Individual employees (3) Studies of substances or process (including as known whose assigned duty is to advise the designated mixtures that a person who byproducts). company of tfie health ahd~^ fx--- is reporting has manufactured or (1) A list of ongoing health and safely, environmental effects of chemicals processed or proposed to manufacture studies being conducted for or initiated under { 710.12. or process only aa impurities are not by them, noting for each entry the (b) Persons who must report (1) A generally reportable under 716,11(i)- purpose of the study, type of data person who manufactures or processes a (4) Research and development studies collected, and progress and anticipated substance or designated mixture listed on chemical substances not on the date of completion. This requirement in ( 716.17 at the time it is listed, or TSCA Chemical Substance Inventory continues until the sunset date specified proposes to do so, must do the following ere not reportable under i 716.11(e). by ( 718.19. Studies initiated after the for that substance or designated (5) Underlying data, tuch as medical initial 60 day reporting period must be mixture--(if Submit copies of afi iron- or health record*- individual files, lab_ listed if they included one or more of the exempted studies in his possession at notebooks and 'daily monitoring records following tests: chronic tests; long- and the time be becomes subject to the rule are not reportable except by special short-term tests or mutagenicity, under i 710.6. Under ( 716.14 the copies request under | 716JC carcinogenicity or teratogenicity; and UCC 006760 Federal Register / VoL 47, No. 171 / Thursday, September1 2, 1982 / Rules and Regulations 38793 the biological and environmental fate tests listed in ( 716.10 (h) through (j). (c) Studies of the following preparations of a substance must be (2) A list of unpublished studies known to theta of which they do not have copies^ The name and address of any person known to them to possess s copy of the unpublished study must accompany each entry on theJisL For purposes of this section only, an unpublished study will be considered to be "known to" a person, if the study can be discovered by a file search in accordance with f 716.12. (b) Submissions under paragraph (a) of this section must be Indexed by chemical, including CAS number if known, and must be accompanied by a cover letter containing the name, lob title, address and telephone number of the submitting official, and the name and address of the manufacturing or processing establishment on whose behalf the submission is made. (c) The list of health and safety studies should be submitted, preferably by oertified mail to: U5. Environmental Protection Agency, TSCA-6D1, P.O. Box 2060, Rockville, Maryland 20652. reported at studies of the substance itself, not as studies of mixtures known to contain the substance. (1) The substance in aqueous solution. (2) The substance containing a small amount of an additive, such as a stabilizer, emulsifier, or other chemical added for purposes of maintaining tha integrity or physical (orm of the substance. (3) The substance at any grade of purity. i 716.10 Reporting physical and chemical properties, - Studies of physical and chemical properties must be reported under this subpart if performed for thejpurpoeejif determining the environmental of ~ EToIdgicanatB ofa substance, and only If they investigated one or more of ike following properties: (a) water solubility. (b) Adsorption/desorption on particulate surfaces, soil. (c) Vapor pressure. (d) Octanol/water partition 1716J EPA requeeta for submission of further Information. EPA may request the following submissions after the initial reporting under || 71BA and 7107. If the requested submissions are not made, EPA may subpoena them under section 11 of TSCA. 15 UAC. 2610. (a) Submission of underlying data of the kind described in 171fL6{a](2) by persons who submit copies of studies under 1716.6 or Ust studies under 1716.7(a)(1). coefficient (e) Density/relative density (specific gravity). (!) Particle size distribution for insoluble solids. (g) Dissociation constant (h) Degradation by photochemical mechanisms--aquatic and atmospheric. (1) Degradation by chemical mechanisms--hydrolytic, reductive, and oxidative. 0) Degradation by biological mechanisms--aerobic and anaerobic. (b) Submission of preliminary reporta of ongoing studies by persona who Ust the studies under i 716.7(a}fl). (cj Submission of copies of studies by persons Usted under | 716.7(a)(2) aa possessing them. (718,11 Exemptions to repotting requirement*. Hie following are exempt from the copy and list submission requirements of ((716J> and 716.7. (a) Studies which have-been published 1716.9 How to report on substances and mCrtursa. Section 716.17 contains two lists, one of substances and one of designated mixtures. Studies of listed substances end designated mixtures shall be reported as follows: to the scientific literature. (b) Studies previously submitted to EPA, ej.. studies voluntarily submitted during section 4 proceedings or under tha previous section 8(d) rule. / (c) Studies previously submitted to ./any Federal agency with no claims of confidentiality. ` (a) When a substance is individually ^'id) Studies conducted or initiated by listed under f 718.17(a). studies of the \ft,ior _____ it subject to substance and studies of mixtures \v{( 716.6 and 710.7. known to contain the substance must be (e) Studies of chemical substances reported as studies of that substance. which are not on the TSCA Chemical (b) When two or more substances are Substance Inventory, eg- research and listed as a designated mixture under development studies on new chemical I 716.17(b), studies of the designated substances. mixture and studies of any mixture (f) The following types of studies known to contain the designated when the subject of the study Is a mixture must be reported as studies of mixture known to contain a substance the designated mixture. or designated nurture listed in { 716.17. (1) Acute ora] toxicity studies. (2) Acute dermal toxicity studies. (3) Acute inhalation toxicity studies. (4) Primary eye imitation studies. (5) Primary dermal Irritation studies. (6) Dermal sensitization studies. (7) Physical and chemical properties. If the substance or designated mixture is an impurity, no reportingjs required (see i 716.11(1), below). (g) Analyzed aggregations of monitoring data based on monitoring data acquired more than five years preceding the date the substance or designated mixture was added to the list in 1716.17. . (h) Analyzed aggregations of monitoring date on mixtures known to contain one or more substance or designsted mixtures listed In | 718.17, when the monitoring data are not analyzed Co determine the exposure or concentration levels of the substances or designated mixture listed in 1716.17. (I) Studies on a substance or designated mixture listed in ( 716.17 that the person who Is reporting has manufactured or processed or proposed to manufacture or process only as an impurity. When reporting of such studies la to be required, that reporting will be separately proposed in the Federal Register. 1716.12 Research. Persons will satisfy the requirements of this Subpart if they limit their search for the required information to records In which such information is expected to be found in tha ordinary course of their business, end to information kept by employees whose assigned duty la to advise the company on the health or environmental effects of chemicals. For purposes of this rule, persona do not nave to search files retired prior to December 31,1979. (716.14 Reporting schedule, (a) Except as provided in paragraphs fb) and (c) of this section, submissions under ( ( 716.8 and 716.7 must be postmarked on or before 60 days after the effective date of the listing of a substance or designated mixture in ( 716-17 or within 60 days of proposing to manufacture or process a substance or designated mixture if first done after the effective date of the substance's or designated mixture's listing in ( 716.17. (b) Persons subject to the listing requirement of ( 716.7 must inform EPA of any study initiated by or for them within the three-year reporting period described in f 716.19 within 30 days of initiation of the study. Copies of studies listed as ongoing under { 718.7(a)(1). or studies initiated within the reporting UCC 006761 38794 Federal Register / VoL 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations period, must be submitted within 30 days of their completion. (c) Respondent* who cannot meet a deadline under this section may apply for a reasonable extension of time. Requests for extensions should be addressed to: Document Control Officer, Office of Pesticides and Toxic Substances, (TS-793), Environmental Protection Agency, 401M Street, SW, Washington, D.C. 20980, Attn: Section B(d) extension. (718.18 ConddsntMtyrtsleis (a) Any person submitting a document under this Subpart may assert a business confidentiality claim covering aC or part of the submitted material. Any information covered by a claim will be disclosed by EPA only as provided in procedures set forth at Part 2 of this title. (b) If no claim accompanies a document et the time it is submitted to EPA, the document will be placed in an open file available to the public without further notice to the respondent (c) (1) Section 14(b) ofTSCA states that ERA may not withhold from disclosure, on the grounds that they are confidential business information, health end safety studies of any substance that has been offered for commercial distribution or for which testing is required under TSCA section 4 or for which notice to required under TSCA section 5, except to the extent that disclosure of data from such studies would reveal: (I) processes used in foe manufacturing or processing of a substance os mixture, or (fi) foe portion of a mixture comprised by any of foe substances in the mixture. (2) Any respondent who wishes to assert a claim that part of a study should be withheld from disclosure because disclosure would reveal a confidential process or quantitative mixture composition or other confidential information, should briefly state the basis of foe claim. Le, by saying "reveals confidential process information" or "reveals confidential mixture proportion data," and clearly identify foe material subfect to the rfatm- Information in a study, such as company name or address, financial statistics, or product codes used by a company, which is irrelevant to any health or environmental effect of a chemical, may be claimed confidential and not subject to the disclosure requirements of section 14(b) of TSCA. Other information contained In a study, foe disclosure of which would dearly be an unwarranted Invasion of personal privacy (such as individual medical records), wili be considered confidential as provided in Title S. United States Code, section 552(bX8). (d) To assert claim of confidentiality for data.contained In a submitted document foe respondent must submit two copies of foe document (1) One copy must be complete. In that copy, the respondent must indicate what data, if any. are claimed as confidential by marking the specific information on each page with a label such as "confidential," "proprietary," or "trade secret" and briefly state foe basis of foe claim. (2) If some data are claimed as confidential, the respondent must submit a second copy. The second copy must be complete, except that all information claimed as confidential in the first copy must be deleted. (3) The first copy will be for Internal use by EPA. The second copy will be placed in an open file to be available to the public. (4) Failure to furnish a second copy when information to claimed as confidential in the first copy will be considered s presumptive waiver of foe claim of confidentiality. EPA will notify the respondent by certified mail that a finding of a presumptive waiver of the claim of confidentiality has been made. The respondent will be given 30 days from foe data of receipt of notification to submit foe required second copy. If foe respondent fails to submit the second copy within foe 30 days EPA will place foe first copy in foe public file. (718.17 Substances and designated mixtures to which this subpart appBee. (aXl) Substances. The following substances era subject to this subpart as of October 4,1902. Substances Acetonitrile. Acrylamide. Alkyl epoxides -- including all noncyclic aliphatic hydrocarbons with one or more epoxy functional groups. CAS Numbers (examples for groups) 75-05-8 79-06-1 75-21-8 75-56-9 106-88-7 1464-53-5 2 fl or alkyl r2 H or alkyl Rj * H or alkyl r. * H or alkyl Groups Ri'R4 may contain one or more epoxide functions me coos mm is is UCC 006762 . Federal Register / Vol. 47, No. 171 f Thursday, September 2,1982 / Rules and Regulations Substances Alkyl phthalates -- all alkyl esters of 1,2-benzene dicarboxylic acid (orthophthalic acid). o il t--O--R, ad--O-R&2 R. alkyl R2 " alkyl ArTiline and chloro-, bromo-. and/or nitro-anilines. - Antimony. Antimony trioxide. Antimony sulfide. Aryl phosphates - phosphate esters of phenol or of alkyl-substituted phenols. Try-aryl and mixed alkyl and aryl esters are included but trialkyl esters are excluded. /OR. o=p^-or2 r3 CAS Numbers {examples for groups) 84-61-7 84-66-2 84-74-2 117-81-7 117-84-0 119-06-2 119-07-3 131-11-3 26761-40-0 27554-26-3 / 62-53-3 108-42-9 88-74-4 121-87-9 89-63-4 141-85-5 95-51-2 147-82-0 95-76-1 554-00-7 95-82-9 608-27-5 97-02-9 626-43-7 99-09-2 634-93-5 99-29-6 635-22-3 99-30-9 827-94-1 100-01-6 1817-73-8 106-40-1 5388-62-5 106-47-8 6283-25-6 3531- 19-9 7440- 36-0 1309- 64-4 1345- 04-6 78-30-8 78-32-0 78-33-1 115-86-6 563-04-2 1241-94-7 1330-78-5 2528-36-1 25155-2326444-4928108-9929761-2151363-6456803-37-3 38785 UCC 006763 36796 Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Ralea and Regulations Substances R^ * phenyl, either unsubstituted or substituted with one or more alkyl or aralkyl groups R2 alkyl; or phenyl, either unsubstituted or substituted with one or more alkyl or aralkyl groups R3 * alkyl; or phenyl, either^ unsubstituted or substituted with one or more alkyl or aralkyl groups Asbestos - Asbestiform varieties of: chrysotile (serpentine); crocidolite (riebeckite); amosite (cumraingtonite- j grunerite); anthophyllite; tremolite; `and actinolite. Bisazobiphenyl dyes derived from J benzidine and its congeners. orthotolidine (dimethylbenzidine) and dianisidine (dimethoxybenzidine). . - T i' ... 1 1 Chlorinated benzenes, mono- and di-. Chlorinated benzenes, tri-, tetra- and penta- CAS Numbers (examples for groups) -- 1332- 21-4 / 12001 -29-5 ' 12172 -73-5 17068 -78-9 72-57-1 2602-46-2 91-92-9 2610-05-1 91-96-3 2893-80-3 573-58-0 3530-19-6 992-59-6 3567-65-5 1937-37-7 3626-28-6 2150-54-1 4335-09-5 2429-71-2 6358-29-8 2429-73-4 6360-54-9 2429-74-5 6449-35-0 2429-79-0 6637-88-3 2429-81-4 6656-03-7 2429-82-5 6739-62-4 2429-83-6 8014-91-3 2429-84-7 10401-50-0 2586-57-4 16071-86-6 2586-58-5 16143-79-6 20282-70-6 95-50-1 106-46-7 108-90-7 541-73-1 87-61-6 95-94-3 108-70-3 120-82-1 608-93-5 634-66-2 634-90-2 UCC 006764 Federal Register / VoL 47, No. 171 / Thursday, September 2.1982 / Rule* and Regulations 38797 Substances Chlorinated naphthalenes chlorinated derivatives o naphthalene (empirical formula c10Hxcly' whera *+y*8). Chlorinated paraffins ~ chlorinated paraffin oils and chlorinated paraffin waxes, with chlorine content of 35 percent through 70 percent by weight. Chioromethane (methyl chloride)* Cresols -- ortho/ meta-, and para-cresol. . Cyclohexanone. Dichioromethane. (methylene chloride) 1,2-Dichldropropane Glycidol and its derivatives. h\/^Vjh*0'r R H; alkyl, alkenyl or alkynyl; aryl; acyl tohere R alkyl, alkenyl, alkynyl, aryl, or acyl; any substituents or functional groups may be present with the alkyl, etc., groups. CAS Numbers (examples for groups) 90-13-1 1321-64-8 1321-65-9 61788-76-9 63449-39-8 68920-70-7 74-87-3 95-48-7 106-44-5 108-39-4 108-94-1 75-09-2 78-87-5 77-83-8 101-90-6 106-90-1 106-91-2 . 106-92-3 121-39-1 122-60-1 556-52-5 930-37-0 2238-07-5 2425-79-8 2426-08-6 2461-18-9 4016-11-9 4016-14-2 13236-02-7 13561-08-5 25085-99-8 26447-14-3 UCC 006765 38798 Federal Register / VoL 47, No. 171 / Thursday. September 2,1982 / Rules and Regnlationa Substances Halogenated alkyl epoxides ~ halogenated noncyclic ali phatic hydrocarbons with ons or nors epoxy functional groups. CAS Nuabera (examples tor groups) 106-89-8 428-59-1 3083-25-8 3132-64-7 X or CnH2n+l-y*y <7"l to 2n+1* *2 - Hor X or CnH2n+l-y,y l*"0 to tj V or X or cna2n+l-yxy to 2n+l) *4 aor X or CnH2n+i_yXy Cy-o to 2n+l> X halogen Groups Ri - X. say contain ons or nora spoxlds functions. Bexachloro-1,3-butadiene. ttexachlorocyclopentadiene. rfydroquinone. Xaophorons. nesltyl oxids. 4,4 *--Nsthylenedianiline. Nsthy1 sthyl kstons. Nsthy1 isobutyl kstons. Iltrobsnssns. p-Phenylenedianine. Polychlorinated tsrphsnyls -- polychlorinatsd ortho-, eta-, and pars-tsrphsnyls. Pyridine. Oilnone Toluene. 1,1,1-Trlchloroethane (ethyl chlorofona). Vinyl fluoride. Vinylidsne fluoride. Xylsns -- ortho-, seta-, and para-xylene. * (2) {Reserved] (b) (Reserved] 87-68-3 77-47-4 123-31-9 78-59-1 141-79-7 101-77-9 78-93-3 108-10-1 98-95-3 106-50-3 11126-42-4 12642-23-8 61788-33-8 110-86-1 106-51-4 108-88-3 71-55-6 75-02-5 75-38-7 95-47-6 106-42-3 108-38-3 UCC 006766 / Federal Register / Vol. 47, No. 171 / Thursday, September 2. 1982 / Rules and Regulations 38799 f71ft.1t Additions to Sets ofsubstances WIO OMIJnlilB mmMrM VO wThRi hW subpart apples. The requirements of thi Subpart will periodically be extended to cover additional substances and deaignated mixturea. Two procedures will be used to add substances,and mixturea. (a) Except as provided in paragraph (b) of this section, anbatanoea and deaignated mixtures will be added after publication in the Federal Register of a notice ofproposed amendment of this . subpart There will be a 30-day public comment period on tbe notice: after consideration of the comments, a final amendment will identify the substances and mixtures added. fb) Substances and deaignated mixtures diet bave been recommended for testing by the Interagency Testing Committee, established under section 4 of T8CA, will become subject to this . subpart 30 days after publication of a notice to that effect in the Federal Register. f71ft.1t Suneet provision. . The reporting period on a-substance or designated mixture will terminate no later than three years after that substance or designated mixture is added to the list in f 718.17. The automatic termination date for die three year reporting period on a substance or mixture will be the annual sunset date (May 1 or November 1) that fella no later than three years after reporting begins. e.g* a reporting requirement taking effect on January 1,1982 would expire not later than November 1,1984. A notice will be published In the Federal Register announcing the termination, date for reporting for the aubatancea and deaignated mixtures listed in f 716.17 (a) and (b). An earlier termination date may be published for a substance or designated mixture at tbe discretion of the Assistant Administrator for Pesticides end Toxic Substances. pa Dm ss^MssriM s4-sa m* MJJNft MHHI / UCC 006767 38800 Federal Register / VoL 47, No. 171 / Thursday, September 2,1982 / Proposed Rules ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part T18 (OFTS-04OO3B; TOM-PUL 2118-8J Health and Safety Data Reporting; Submission ofLists and Copies of Health and Safety Studies AOENCy: Environmental Protection Agency (EPA). Acnote Proposed rale. SUmmaky: This Is a proposal to add to the list of chemical substances and mixtures for which lists and copies of unpublished health and safety studies must be submitted under section 8(d) of die Toxic Substances Control Act (TSCA). 15 U.S.C. 2807(d) (40 CFR Part 716 Subpart A). Tha chemical substances proposed to be edded were recommended for testing by the Interagency Testing Committee (ITC), hi their sixth through tenth reports to EPA (45 FR 35687, 45 PR 78432,48 FR 28138, 47 FR 5456, and 47 FR 22585), The ITC was established under section 4 of TSCA. date Comments must be submitted on or before October 4.1882. AOOmns: Written comments should bear the document control number OPTS-64003B and should be submitted to: Document Control Officer (TS-793), Office of Pesticides end Toxic Substances, Environmental Protection Agency, Roam E-408,401M St, SW, Washington. DC 20460. Ail written comments filed under this notice will be svaiiable.for public inspection in Rm. B-107 from &00 ajn. to 400 pun. Monday through Friday, except legal holidays. FOR FURTHER INFORMATION CONTACT: Douglas Bannennan, Acting Director. Industry Assistance Office (TS-789), Office of Toxic Substances. Environmental Protection Agency, Rm. E-511,401M St. SW, Washington. DC 20460. Toll free: (808-124-8085); in Washington. D.Cu (554-1404); Outside the U-SA-* (Operator-202-654-1404). SUPPLEMENTARY INFORMATION: Elsewhere in today's Federal Register EPA is promulgating regulations under section 8(d) of TSCA to require submission of unpublished health and safety studies on specifically listed chemicals by chemical manufacturers and processors. Other persons in possession of such studies may be asked to submit them voluntarily. This rule establishes standardized reporting requirements and provides for amending the list of chemicals subject to the rule. Under'this propose! EPA would If we same 30 percent margin of amend the list of chemicals by adding error In these estimates the range of tha chemicals recommended for testing probable cost varies from $138,000 to by tha rTC In its sixth through tenth $254,000. reports. Comments are solicited on this amendment In the future, all ITC- Public Record recanunended chemicals will be subject EPA has established a public record to tha rule effective 30 days after (docket number OPTS-64003B] for this publication of a notice in the Federal proposed rulemaking document which, Register to that effect (See 40 CFR along with a complete index, is 718.18.) available for inspection in Rm. K-107 We propose to add tha following from &00 a-m. to 4:00 p.m. on working chemical substances and categories of days (401M Street SW, Washington. chemical substances to 40 CFR 716.17. The ITC report number in which the recommendation waa made follows each chemical substance or category of D.C, 20460). This record includes basic information considered by the Agency in developing (his proposed rule. The Agency wtil supplement the record with substances listed-below. additional information as it is-received. Chsmlcals Proposed for Addition to Rule The record includes the following categoriea of information: Categoriea ofChemical Substance* F%enylenediamin*--9th Report (1) Health and Safaty Study Reporting Regulations (40 <2fR Part 710), Public Record. Flaoroalkenes--7th Report Docket No. 064003. Chemical Substance* Benzyl butyl pbthalate--7tb Report . (2) Reports Inspect Analysis for 40 CFR Pert 710 and this proposed rulemaking. (3) eth-10th Reports of the Interagency Biphenyl--10th Report Testing Committee (ITC); 45 FR 39097 (0th Butyl gJycoJyl butyl pbtfaslate--7th Report Report), 45 FR 78432 (7th Report). 40 FR 28130 CMormdtc add--4tb Report 4-Chkxobeiuotriflsaride--9th Report (0th Report), 47 FR 5450 (9th Report), end 47 FR 22585 (10th Report). Z-Chlorotoluene--Sth Report Diethylenetrtamine--Sth Report Ethyltoluene--lMh Report Farmamids--10th Report EPA anticipates adding to the rulemaking record the following types of Information: Hexechloroethane--Sth Report LZt-Trirnethyfbenxene--10th Report (1) All comments on this proposed amendment. Iris (2-Qdoroethyl) phosphite--4>th Report (2) AH relevant support documents and Under the rule implementing section 8(d) of TSCA, EPA will acquire studies. (3) Record* of all communications between EPA personnel and parsons outside tha unpublished health and safety studies Agency pertaining to tha development of this an these chemicals from manufacturers and processors of the chemicals. The Agency will use the studies to support its investigations of the risks posed by the chemicals and. in particular, to support Its derisions whether to require industry to test chemicals under section 4 of TSCA. Use of the studies in this rule. (This doe* not include any intar- or intra-agency memoranda unless specifically noted in the index of the rulemaking record.) (4) Minutes, summaries, or transcripts of any public meetings held to develop this rule. (5) Any factual Information considered by the Agency in developing the rale. (0) Comments received from OMB under the Paperwork Reduction Act way was the subject of comment during the rulemaking proceeding for the rule. Our responses to section 8(d) issues raised in response to the proposal are part of the rulemaking record for that rale. EPA will identify the complete rulemaking record on or before the date of promulgation of the regulation, as prescribed by section 18(a)(3) of TSCA, and will accept additional material for inclusion in the record at any time Economic Impact between this notice and such EPA estimates that these additional chemicals will cost industry $195,000 to submit the required data, litis consists designation. The final rule will also permit persons to point out any errors or omissions in the record. of the following: Regulatory AjBasement Requirements; Paperwork Reduction Act Coupon-- Aulv 1 KZjOOO Cmpormto Ftowvv (to** WwaWolonfr ........ mnrnKt .....tutu** *ooe ftotoaopt** (wtoitol ..................... 9*000 4*00 WWopj*tB (toOoA .. . . -------- 11.000 Ifc--7*000 Onprwiq ftopQ4*H , , , 1*000 The reporting provisions of the final section 8(d) rule have been submitted *0f0or approval to the Office of Management and Budget (OMB) under section 3504(b) of the Paperwork Totalt*000 Reduction Act of 1880 U.S.C. 3501 etseq. The final rule will explain how its UCC 006768 i Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Proposed Rules reporting provisions respond to any OMB or public comments. This rule requires manufacturers and processors of eight chemicals and two chemical categories to submit unpublished health and safety studies relating to these chemicals. The studies to be submitted will be used by EPA in evaluating health and environmental effects of chemicals for purposes of assessing risks associated with the chemicals, as well as in determining whether the chemicals should be included in testing rules Issued under section 4 of TSCA. This regulation was submitted to the Office of Management and Budget for review as required by Executive Order 12291. List of Subjects in 40 CFR Part 710 Chemicals, Health and safety. Environmental protection, Hazardous materials. Recordkeeping and reporting. Dated: August 23,1962. John E. Denial, Acting Adminutrator. Regulatory Flexibility Act This rale (amendment). If promulgated, will not have a significant economic Impact on a eubetantial number of small entities. Based on our experience with a previous section 8(d) rule.'we expect that only about 1 percent of the respondents will have gross sales of less than 820 million. Further, approximately 90 percent are expected to have gross sales over 8100 million. Thus, of the approximately 172 companies expected to report under this rale. 156 are expected to have sales greater than 8100 million. Only two companies are expected to have groaa sales under 820 million. Therefore, in accordance with the Regulatory Flexibility Act (Pub. L 96-354), EPA has determined that this rule will not have a significant economic impact on a t eubetantial number of small entities. PART 716--HEALTH AND SAFETY DATA REPORTING Therefore, it is proposed that Title 40, Chapter L be amended by adding 1716.17(a)(2) to read as follows: { 716,17 Substances and designated mixtures to eWdi this eubpart applies. (I * * * (2) Aa of the date of publication of the final rale (amendment) in the Federal Sagistar, the following chemical substancet are subject to this eubpart Stenn Sne>lbMe>|Wilili-------Suei SWW WM pMMeto. --CASl S-70-1 ns-a-s U4M 111-40-0 ssaao-14-i Executive Order 12291 Under Executive Order 12291, EPA must judge whether a regulation is "major" and therefore requires a Regulatory Impact Analysis. EPA has determined that this regulation is not major because It does not have an effect of 8100 million or more on the economy. It is expected to have a one-time coat of about 8195,000. It does not have a significant effect on competition, coats or prices. S gm* fcnnuut CWW. etew * lean t er S *n* let >Mkie mm a mc MfeSetoe MMe_,, WeHklMM__ . HsWtooroprepvns-- THSiOtoHMotoOMne. PtnutonrttownM pmrnrMdtone-- and Mr 110-14-1 J60-11-* 7VJO-7 7-oe- 116-1S-4 tTT-il-4 7S-1M *7-71-1 0* |R Doe. A-MMt fQod G-l-tt Ml SNJJMQ COOC -- -- M 38801 / UCC 006769 INTERNAL CORRESPONDENCE UNION CARBIDE CORPORATION old ridgebury road, danbury, ct dgbi7 to {Name) Mr. W. J. Hansen o.von Mr. W. E. Whitehurst t-ocacjpn Ara Copy to Mr. J. H. Barrett Mr. T. L. Collins Mr. R. A. Matthews Oat* October 21, 1982 O^*0fnt.rg Dept. HS & EA Ar** P2 612 Subject TSCA SECTION 8d REPORTING Gentlemen: You will be receiving a letter from Don Heywood outlining a coordinated program for responding to a September 2, 1982 final rule by EPA calling for submission of health and safety data on specific chemicals under authority of the Toxic Substances Control Act. By definition, EPA considers health and safety study data to include ef fects to the environment which potentially broadens the request to include information that your groups have generated in the past. An attachment lists my current opinion of the types of data from your groups that is included and exempted from the request. Basically, this would exclude all paper studies and analyses of releases and include all analytical data actually measured in the environment as well as physical properties. I plan to review these opinions with the Law Department and make any subsequent modifications needed. In the meantime, it is my understanding that your Divisions will expect you to begin the search program that will be outlined in the letter from Don Heywood for the materials you possess as a "location". I will promptly inform you of any changed directions for environmental data. Sincerely, FDB/kd Attachment F. D. Bess UCC 006770 The following types of data are included or exempted from submission requirements under TSCA Section 8(d). ENVIRONMENTAL DATA Included - Measurements of listed substances in receiving waters or the atmosphere - Acute aquatic toxicity on listed substances (unless reported in a scientific journal) f - Physical properties of obtained to determine environmental fate: Adsorption/desorption on particulate surfaces (e.g. soil), Octanol/water partition coefficients, Phetochemical degradation. Biological degradation. Chemical degradation Exempted - Measurements of listed substances in sewers,-treated effluents or stacks - Environmental Impact Analysis program to the extent that it is based on calculated rather than measured concentrations and/or effects - Engineering studies for new or modified systems based on calculations rather than measured values UCC 006771 DOCUMENT(S) INTENTIONALLY REMOVED UCC 006772 ( c ' 0 ./ CONSTRUCTION SAFETY DEPARTMENT TRAINING RECORD Type of Training Da te Instructor NAME EMPLOYEE NO. CRAFT \ i SUPERVISOR I 2. I 3I 4. 1 5. I 6. I 7. I 8. 1 9- 20. 2 1. 2 2. 2 32 U. 2 5- UCC 006773 PRACTICES AND PROCEDURES IN ASBESTOS CONTROL UNION CARBIDE, Charleston, WV April 8, 1987 AE75580 SIGN-IN SHEET NAME {please print) t soc SBC # SIGNATURE i. /T Mm/'SqaJ 2. C.Atttu 3- ___4^-< < 4- h-eierkk ~iv Ctuccli J36 -7031 - ^L., beu<J! J33'f?Q-7(rP fafoL /d^ SiP -J-22S luLl1? 5. ___UA. &r"<3gy\ /<g,g_______ ^ 3^ ~ Ol l<f 6. ft .. R<*l*e-s \l/2^<ie. H. <Sr\o\)gK 7. -112.r_goM /ffSeP'/AVs) '~7%^/n4rf~?rr''A,^ 9. zA3ri- ^ nzso .10 Ai?/r,-rt Ayr? SXc'-J-S-sr*'/ .11 ff.lh&rT F T^rry____________ Zll-ns-jj,9 .12 13. 14. 15. 16. 17. 18. 19. 20. UCC 006774 PRACTICES AND PROCEDURES IN ASBESTOS CONTROL UNION CARBIDE, CHARLESTON, WV April 8, 1987 AE75580 SIGN-IN SHEET NAME (please print) SOC SBC # SIGNATURE 1. jJobJdrd <z). 2-2*43 2. HckiO C . ft'/ei 3* /' 4. /d. unde.y la sis-f . Ph-itLe. 5. 6. do//*J A?. (2ot?/2/<=7. lO. a/.a-us -m tdd/udrjA 7 ? 7 - 5~-? - .'T~/ ?. ^32-3&-3odL PfP/< 1/3A. SI<^~ 6.3-^V9 Z7&(2>u^ J-IZ-?/'/?**# B* 2S2-<fr-QS%<T 232-fTC- ?33J C^SLo'yyt^lf^ j 10- S* EusItwc n. C A i2. rt qr.tk 13. r!n 14. Z1Z -4>4-9o5 3 ^3/' 90-/J7* 232 u? AA2 - - 5?7/<? Ss 15. 16. 17. 18. 19. 20. UCC 006775