Document MpQMnaayv7ZovormK3p4JbjM

jj ly-oo? UNION CARBIDE CORPORATION 1/626 LL i.AMINO FHk: A1. iiOUl h'VAHD HOUSTON. rtXAS 77056 29 October 1982 TO: R. E. Feele 511 Attached are letters from Don Heywood and Doug Bess relating to UCC's compliance with the final rule requiring submission to EPA of certain unpublished health and safety information as authorized under TSCA, Section 8 (d).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 r > f 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 Q6ai7 To (Name) Division Location Area Copy to U.S. General Occupational Health Committee Members U.S. Corporate Product Safety Committee U.S. Divisional Environmental Protection Coordinators ate 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, HS&EA 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: F. D. Bess, environmental; N. W. Gaines, Occupational Health; R. G. Hanlon, Industrial Hygiene; D. L. Heywood, general; T. R. Tyler, toxicology; J. J. Brezinski or C. E. 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 & 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's Inventory, 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 D.L. Heywood, for the 8(d) Task Group UCC 006742 HEALTH AND SAFETY STUDY SUBMISSION PLAN TSCA SECTION B (d ) ATTACHMENT II STUDIES TO BE REPORTED (Health and Safety Studies not Specifically Exempted.) A. 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 studies (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 aggragated and analyzed to measure the exposure of humans or the environment to a chemical on the list. B. 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. f o Studies conducted on chemicals not on the TSCA inventory. o Reports 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, 1982 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. Halogenated 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 Methylene Chloride 74- 87-3 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 Haloanilines Bisazodiphenyl Dyes Pyridine p-Phenylenediaraine 7. Aryl Phosphates: Trieresyl Phosphate 8. Alkyl Phthalates Di-2ethylhexyl phthalate Other Plasticizers (phthalates) 9. Aromatic Hydrocarbons: Toluene o-Jtylene 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 ; 38780 ^. ATTACHMENT Federal Register / Vol. 47, No. 171 / Thursday. September 2,1982 / Rules and Regulations ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 716 (OPTS-64003A; TSH-FRL 2112-2] Health and Safety Data Reporting; Submission of Lists and Copies of Health and Safety Studies AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. Summary: This rule requires the * submission ofunpublisheJ health and safety studies on specifically listed" chemicals tty chemical manufacturers, processors, and others in possession of such studies. The rule is issued under secfibn6(d] of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2807(d). The Administrator will issue amendments in the Federal Register to add to die list of chemicals subject to the rule. Amendments to add chemicals recommended for testing by the Interagency Testing Committee (ITC). 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 notice promulgates the final version of regulations proposed on December 31,1979 at 44 FR 77470. EFFECTIVE DATE October 4,1982. FOR FURTHER INFORMATION CONTACT: Douglas Baimerman, Acting Director, Industry Assistance Office (TS-799), Office of Toxic Substances, Environmental Protection Agency, Rm. E--511,401M Street SW,, Washington, ... DC 2046ft toll free (000-424-9065); in Washington, DC (554-1404); outside the ' USA (Operator-202-554-1404). SUPPLEMENTARY INFORMATION: OMB Control Number 2070-0004. "Background In the Federal Register of July 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 ITC 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 F.2d 673 (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. The 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 peopTFor the environment arethe mndamentaTuigredTents of any assessment ofcEemicalrisk. For this reasonTEPA wQI 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. Hie 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 ITC-reconunended 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 effect 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 testing decisions. Overview of Rule Requirements . Extensive comment was received on the question of whet records a company should search to comply with this rule. The proposal spoke of informatibn "known to" or in the "possession" of respondents. The definitions given for these terms were broad, end comments indicated that under these definitions, companies would feel obliged to search many more records than we believe necessary. We have decided to replace ~~ the definitions with a description of the scope of a search that will be adequate for this rule. Hie rule now says that respondents are responsible for ' searching only the company files in which they ordinarily keep studies and the records kept by employees whose assigned duty is to advise the company on health end environmental effects of. chemicals- Moreover, for all compliance purposes, respondents need not consult any records that they retired prior to December 31,1979, the date on 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 chemcial. 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 subject to the rule. An examination 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 persons who begin, or are proposing to begin, manufacturing or processing a listed chemical during that period. Persons who are not Involved with a chemical when it 1b listed but manufactured or processed it or proposed to do so any time during the ten years prior to the time it is 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 38781 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] non-confidential studies submitted previously to another Federal agency; (5) all studies previously submitted to EPA (this includes studies voluntarily submitted during section 4 proceedings or under the previous section 8(d} rule); () 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: acute oral toxicity studies, acute dermal toxicity studies, acute inhalation toxicity studies, primary eye liTitation studies, primary dermal irritation studies, and physical and chemical properties. Organization of This Preamble EPA received more than 100 responses to the proposed rule, 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 areas: specific definitions; chemical substances subject to the rule; 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 0(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 & D), as well as byproducts and impurities of commercial manufacturing and processing, are "for commercial purposes." ETA 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 made for commercial purposes. Moreover, the reason that section 6 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 and 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, and R ft D chemicals because they were not considered to be "for commercial purposes." On the contrary, this section 8(d) rale is completely consistent with the Inventory rale, both rules define these chemicals as "for commercial purposes." The Inventory Rule exempted such substanaes only because they were not appropriate for inclusion in the Inventory. In tills 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 fromreDortmg any studies of chemicals that the person reporting Eas manufactured orprocessed or has proposed to manufacture or process only as impurities. 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 as not to justify the burden of searching for them. However, in other circumstances, the Agency may propose to require the excluded studies to be reported for some chemicals.* (2) Byproducts. It should ba 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 from the product, are impurities of the product . and are thus hot 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 are manufactured for commercial purposes, Dow v. EPA. 60S F. 2d 673 (3rd Cir. 1979). EPA discussed the importance of these studies in the preamble to the proposed rale and 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 persona from reporting studies on chemical substances that are not on the TSCA Chemical Substances Inventory, e.g., 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. B. 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 studies might be missed if these persons 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 early in a company's deliberations and that "propose to" should not hinge on a management decision t$ 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 a person toward the manufacture of a chemical. Until the substance is actually manufactured, all the actions 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 clear 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. When a person is ready to submit a section 5 notice, he is beyond the initial stage in which he "proposes" to manufacture for purposes of section 8. llie 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. . G Health and Safety Study Many commenters argued that some of the examples of health and safety studies given in the proposed definition ere 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 it intended that the term (health and safety studies) be interpreted broadly. Not only it 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. H.R. Rep. No- 94--179, 94th Cong,, 2nd Sets. 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 years 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; (ej 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 fate of a chemical which Ib based on physical and chemical properties, that may be released to the envirionment is of critical importance. It is possible that a highly toxic, easily degradable substance will be Iobs an object of concern than a less toxic, persistent chemical Recent technical reports have indicated the importance of environmental fate testing. For chemicals that are likely to be released to the environment, environmental fate 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. (See Howard. P. H.. et. al Environmental Science and Technology, 12(4), 407 (1978)). ' 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, 1982 / Rules and Regulations 38783 (3) Underlying data. Data such at 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 for studies is too indirect The matter Is discussed further under the preamble section titled "File Search." . n. Chemical Substances Subject to the Rule Section 716.17 of the role contains a list of chemical substances subject to the rule. A subsection of { 718.17 is reserved for future listing of designated mixtures subject to the rule. The majority of the chemicals presently listed are ones for which the FTC 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 done, and to base judgments about testing on as full an overview of existing information as practicable. Hie goal is to focus proposals for testing as efficiently as present knowledge will permit. The list in { 718.17 contains two groups of chemicals. One group consists of the chemicals recommended by the ITC for testing. The other group of chemicals indudes the asbestifonn varieties of chrysotile, croddolite, amosite, anthophyilite, tremolite, and actinolite, i.e, asbestos, which is being considered for control. The bisazobiphenyl (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 "organotins" (selected by EPA] was subsequently recommended for testing by the ITC, 45 FR 78432 (November 25,1980). The ITC had recommended the subset "alkyltins." However, die 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 organotins for a later proposal. Another category of chemicals, acrylic acid and methylacrylic add and their esters, has been removed from the rule. EPA will propose the category in a future iteration of this rule after it has better defined the category. Dioxin and related substances have also been removed from the rule. Since proposing their inclusion in this rule, 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 rule Include acrylonitrile, alphachlorotoluene, benzene, benzene (epoxyethyl), chlorendic anhydride, chlorodifluoromethane, 1,2dichloroethane, 2-chloro-l,3-butadiene, ethyl benzene, iodomethane (methyl iodide), morpholine, nitrosodiethanolamine, 2-nitropropane, and vinylbenzene (styrene). These chemicals were removed for a number of reasons. Some (e.g., benzene, styrene) were the 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 were added to the proposed rule. 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 the rule that the information requested is not available from other sources. EPA believes it has justified, to the extent required by section 8(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 all available sources and a complete hazard analysis of the chemical. Thus, according to the comments, section 8(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 8(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 Sess. 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 are 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 are 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 / Thursday, September 2, 1882 / Rules and Regulations and will not burden more persons than necessary with reporting obligations. EPA concurs that sb a matter of sound policy these factors should be considered by the Agency for this section 8(d) rule, 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 some types of studies and some chemicals that were originally part of the proposal Many comments objected to the Agency's automatically making subject to the rule chemicals recommended for testing by the ITC. These comments claim that recommendation for testing by the ITC is 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 a decision to proceed with or abandon testing on the basis of information in hand; 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 testing may have been initiated or all manufacture and processing may have ceased. EPA does not find 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 has such a short period of time to make this decision, die Agency must proceed as rapidly as possible to gather available data on a chemical. To decide whether to propose a test rule within one year, the Agency needs 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 must complete their analyses for EPA decisionmakers to consider. EPA has previously discussed in this preamble the importance of section 6(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 studies at this late stage that could cause fundamental revision of the basic analyses would make it impossible to meet the Agency's one- year deadline. The Agency has also considered in this section 8(d} proceeding a large number of issues relating to reporting of . unpublished studies. The Agency has been unable to determine, and no comments have been presented to indicate, that any other issues would be raised in a 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 is not for determining whether to proceed with testing under section 4, but is 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 haa found that while studies may be voluntarily submitted in some cases, all companies will not do so. Inquiring after voluntary submissions is 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 system to enable more efficient retrieval of studies requested under section 6(d). After considering these costs against the relatively quick need the Agency has 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. m. 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 of Studies 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 S 716.17, within the ten years preceding end including the date die chemical is listed, will be required to submit copies of any unpublished studies he possesses on that chemical Second, EPA may request copies from persons other than manufacturers and processors of the chemical when such persons are identified as poBBeBsing studies listed by someone else in accordance with { 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 distributors 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 pest 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 has changed the initial reporting under the rule accordingly. However, EPA may later UCC 006752 Federal Register / Vol. 4?, No. 171 / Thursday, September 2, 1982 / Rales end Regulations 387B5 request any person, who is listed I need only consult its records not retired pursuant to f 710.7 as possessing a prior to December 31,1979, either for study, to submit that study. studies or for answering the question of (2) Limit the copy submission whether ft dealt with a chemical in the requirement of past manufacturers to past The more valuable, older studies those who have manufactured since > will likely have been preserved in ISOS. 1970,1975, or presently \ current files, rather than being retired. In manufacture instead of since 1950 as \ addition, eearching long-retired files proposed. The commenters maintain V could be very 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 maximize 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 date to define the limits EPA retained the reporting - of the file search. requirements for past manufacturers 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 date under a 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 laet thirty years would have utilized higher quality data developed by the more advanced analytical techniques. manufacturer or processor. Thq Agency received comments EPA did not adopt this suggestion for basically agreeing with EPA's view that two reasons. Complete reporting for the there is a time in the past beyond which Inventory was limited to manufacturers techniques were not to good as they are whereas section 8(d) also applies to now. However, commenters suggested processors. In addition, the implicit cut-off dates from 1905 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 list of their Inventory chemicals is not information more than ten 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 8(d) For instance, the late 1900's saw the rulemaking and subsequent regulations first conunerically available liquid by asking major manufacturers chromatography unit while the first gas voluntarily to submit studies. If chromatography unit with infra-red manufacturers refuse to do so, then the spectrophotograpby was not available Agency could proceed with section 8(d) until 1972. Also, many of the screening rulemaking, or go directly to section 4 tests 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 la 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 years 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 date companies an very reluctant to submit would result in sn ever-lengthening span voluntarily. as this rule is used in the future. (5) First requin lists or titles of Most of the concerns expressed about studies that have been performed by the long time span were concerns 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 a basis for study selection. (8) Limit initial reporting to key studies relevant to specified effects (such as those the ITC recommends be tested) in order to produce studies most valuable to risk assessment and to reduce reporting burdens and EPA's review burden. This suggestion was not adopted? 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 dose (LD50) of a chemical substance fits . relative toxidty), but also may provide data to Judge its modefs) of action, to determine its specific toxic effects) on target organs and functions, and to determine the existence and extent of species differences in sensitivity to a chemicaL Acute effects studies designed to measure potential ecological effects are especially valuable since there la comparatively less Information in this field than in others. 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 for -- Economic Cooperation and - Development (OECD) has developed n base set of recommended teats containing a range of tests of physical and chemical properties and toxicity lev assessing the hazards of chemicals. It has selected many physical and -- chemical properties that in its view, constitute "information for degradation, accumulation and even noxious effect* assessment * * * . For example, the shape of a particle can, in itself, be indicative of its carcinogenic nature " (e.g., asbestos fibers) and the partition coefficient is indicative of likely .. - accumulation in lipid tissues." OECD . Chemicals Testing Programme, Expert Group, Physical Chemistry, Final Report VoL L p. 41. In addition to physical mid chemical properties, the OECD has also included many acute, subacute, and chronic testa 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 the ITC recommendations and reduce 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 cbemiala 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 the proposed listing requirements. The studies to be listed 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 twill 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 a 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 rules 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 die 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. If for example, the Agenpy 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 { 716.8, 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 test 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; (Z) 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 5 716.11 (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 the studies reflect effects of the pertinent substance. EPA will make this judgment By expanding the list of studies that do not have to be submitted and removing the review necessary to determine which mixture studies should be submitted, the reporting burden on persons will be significantly reduced. B. "Substance" Versus "Mixture" In the final rule ( 7ie!#), EPA clarifies how certain preparations of substances should be treated. For example, one commenter Indicated that he considered an aqueous solution of a Bubstance 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 as studies of mixtures containing the substance; UCC 006754 Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations 38787 (1) The chemical substance in aqueous purpose properties, such as octanol/ association that contracts for testing solution. water partition coefficients and (including trade associations such as the (2) The chemical substance containing degradation properties, the company Chemical Industry Institute of a small amount of an additive, such as a wifi not be determining these on a Toxicology). EPA considers this to be a stabilizer, emulsifier, or other chemicals routine basis and should be able to reasonable change. Since only those added for purposes of maintaining the check with one or two key personnel to studies under a company's control and integrity or physical form of the see if these studies were performed. sponsorship are covered, there will be substance. Companies possibly subject to the no need for a search; the report to EPA (3) The chemical substance at any rule because a listed substance is a will be made when the study is ordered grade of purity. component of a mixture should be able to be done. In addition, EPA has limited Studies of these preparations of to examine the mixture itudierthey this continuing reporting requirement to substances are classified for reporting possess to see if any components of the chronic studies; long- and short-term as studies of the substance. EPA does mixture studied are on the section 0(d) tests of mutagenicity, carcinogenicity, or not and need not at this time reach the chemical list Since most of the studies teratogenicity; and the biological and issue of whether these preparations are normally performed on mixtures are environmental fate tests listed in defined as mixtures or chemical exempted by the rule, most companies { 716.10(h) through (f). substances under TSCA. will only have to examine a handful of Another concern of the comments was V. File Search Because of the considerable confusion on the part of coriunenters regarding the file search required by the proposed role, the final rule contains a provision describing the file search required. * Persons can satisfy the requirements of this rple 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 is to advise 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 resources. The Agency is not saying that this is how companies subchronic and chronic studies on mixtures to determine which studies should be submitted. VL Reporting Schedule and Sunset Provision Persons must submit liBts and copies of studies no later than sixty days after the effective date of promulgation of the list of chemdal substances and mixtures in S 716,17. The rule 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 la retaining the proposed schedule because it has made significant changes to reduce the search burden. The scope of this final rule is less than that of the previous section 8(d) rule under whichjxunpaniea^ ftl t reported ln-38?9'ihce many exemptions that the five-year period for reporting completion of ongoing studies or initiation of new ones is too long, especially since EPA must act on chemicals recommended by the ITC within twelve months. The Agency believes that a multiyear period is necessary. The 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 period during which new datajrf me initiatioh ofnew studies 0 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 the Agency's evaluation of the chemical subsequent to testing and could contribute to a decision whether control action for the chemical is indicated. However, to balance EPA's needs against the burden of this must search. to the required studies and the requirement EPA has decided to For small to medium size companies responsibilities of respondents have maintain a multiyear approach but to that believe they are subject to the rule been made. No company requested an limit it to three years. EPA believes that and have few studies of any kind, it may extension of time for reporting under the this represents a minimal reporting be more cost effective to scan the titles rule's sixty-day schedule. Based on the burden since the only studies covered of the studies they possess and then # 7 1979 experience, and because of the by this requirement would be presently check to see if the chemical studied is reduced scope of this rule, the Agency ongoing studies which are completed on the list of chemicals subject to the believes that sixty days is an and studies initiated during the three- rule. EPA's experience has been that appropriate period year period. Also, the rule now allows smaller companies eubmit few studies As proposed, the rule would have the Assistant Administrator to terminate and will find it easier to match studies required that persons subject to the list the requirement for reporting about a against the chemical list Large submission requirement inform EPA of particular chemical if he decides that companies might use the same approach any study Initiated during the five years further reporting is not needed. depending on how their files 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 rule. Also, the prior to the sunset date. Comments considered this to be too burdensome since it would require them to search continuously for all new studies. EPA agrees that the proposed provision was too broad. The Agency has changed the requirement Under the final rule, these persons will be responsible only for informing EPA of studies initiated by or V1L Confidentiality EPA is aware of the need to protect confidential business information. Several commenters suggested that the regulations should contain a specific statement about the means EPA would use to protect the confidentiality of information in the unedited copy of a Agency expects that companies will for them, rather than of any new study. study. have a special reference file for the most Hub includes studies directly contracted The TSCA Confidential Business standard properties such as solubility or for by the company or studies sponsored Information Securuty Manual contains - vapor pressure. For other, special 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 mixture proportion or process locations which must be accessed. Once information submitted under TSCA. 'information, or that the information is the studies are located, the remaining (The manual is available from the OPTS clearly irrelevant to the health and compliance costs involve copying and Industry Assistance Office--see FOR safety study. EPA doeB not expect processing the studies, making lists of FURTHER INFORMATION CONTACT.) EPA detailed substantiation of confidentiality studies which are in progress or not in will share confidential information with claims at the time the study is the possession of the respondent, and contractors, other EPA offices, and other submitted. The Agency believes that this reviewing the studies for confidential Federal agencies only in accordance simple statement is justified, because information. The Agency's cost with these procedures. In addition, all EPA heeds some understanding of the estimates are based on the cost to an " information claimed.as 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 the claim to have a basis for initial denial or granting of FOIA requests and to protect the information. Another suggestion was that failure to provide a nonconfidential second copy average firm. EPA recognizes that actual costs will be larger or smaller for larger or smaller firms. Each of these costs is tabulated below. study confidential However, health and of a study for which claims are made Tam 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 should not be considered a presumptive waiver of the claim. The commenter asserted that the claim to a trade secret is a property right and cannot be taken away by the operation of a presumption. In their view, once the claim is made, it must stand unless a disclosure request is Corpora* rate wi*.... ...... .... --....... THU tattng ... ..... *89,000 87.000 inooo 7,000 - 9,000 28.000 189P08 27,000 composition of mixtures, or contains made and FOIA principles require that it 537.000 information the disclosure of which be granted. would clearly 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, as provided in 40 CFR 2.203(a)(2) and in the manner specified in ( 716.16 of this regulation. This rule requires submission of two copies of studies containing confidential material--one copy indicating what data are claimed 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 claim 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 tiie proposed regulation that detail the methods for submitting confidential Information. , One assertion was that submitters should not be burdened with "up front" substantiation for claims of confidentiality, and that such substantiation should be required only if EPA receives a Freedom of Information Act (FOIA) request for the information. 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 sufficient time to respond. The rule nas been changed to extend the proposed 20-day grace period to 30 days. Tliis should be adequate for such a straightforward response, even given mail delays, because the only step needed is to provide a second, non- litis 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 test on a subject chemical, the cost avoided could exceed the total cost 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). confidential copy for the public file. The Agency received many comments A final specific comment was that the suggesting that its original estimate of Agency must not allow confidentiality $410,000 total cost was too low. The claims for submitted health and safety comments pointed to many features of studies. To do so, is, in the commenter's the proposed rule that they believed view, a direct illegal contradiction of would cause much greater burdens than section 14(b) which exempts the results the Agency had assumed. However, of health and safety studies from such only a few comments actually gave EPA daims. estimates of the time or money they EPA disagrees that It should not allow would expend In complying with the confidentiality daims. Respondents may proposal. For example, the Chemical daim any information as confidential; Manufacturers Association suggested however, the only information which the from a survey of thirteen of its members Agency may actually keep confidential - . that the cost per company would be $400 is listed in $ 718.18(c). to $10,000 per chemical, but this range estimate was not accompanied by data Vm Economic Impact to indicate how the figures were The Agency will not require "up front" EPA estimates that the total cost to generated substantiation. The language of industry of submitting lists and copies of The following 1b a list of the most f 716.16(c) has dropped the requirement health and safety studies under the burdensome features of the proposal as that the basis of the claim be present rule is approximately $537,000. cited by comments. For each feature, a "explicitly'' explained at the time of The major cost to a firm will be the description follows for the changes submission. The claim must still be cost of a file search to determine what made in the final rule to reduce the explained briefly. However, this health and safety studies it possesses. burden. explanation should merely be a simple This cost will, of course, vary directly (1) One large burden commenters statement indicating that the reason for with the size of the firm, assuming that perceived was in searching for routine the claim is, for example, related to larger firms have more files at more monitoring records and for medical i i ! I I UCC 006756 Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations 38789 records. The commenters 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 of the studies performed on the listed (2] The proposed requirement to the exemption for a number of reasons, substances are initiated by the submit all studies on mixtures - one being that these studies may be in a manufacturers and primary processors containing a listed substance would different set of files at different of the substances, which is the reason have caused several problems. . locations than other studies. EPA has EPA exempted distributors from . according to many comments. The not fully exempted these studies {see R reporting. These companies are heavily problems would have come in searching & D Chemicals) because, as previously concentrated in the chemical, allied through records to determine whether a discussed in this preamble, the Agency products, and petroleum refining listed substance could be present In a does not believe that the fact that a industries. studied mixture and in then deciding . studied chemical has been in research whether the listed substance was and development Is relevant to the value responsible for whatever effect the of the study. 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 Furthermore, the changes, exemptions, and limited file search prescribed in this rule should eliminate the possibility of a substantial burden of unavailing searches. on mixtures. It has excluded most acute studies. (8) The analysis accompanying the studies from the requirement; It has [8} The report's impact analysis for proposal did nofconsider the ongoing excluded all physical/chemical the proposal did not include the burden cost of reviewing newly completed roperties of mixtures; and the Agency to a company to familiarize itself with studies during the multiyear follow-up as 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 the final analysis. consideration of ongoing studies poses a removed the requirement for (7) The report's impact analysis for substantial burden that would respondents to decide whether the effect the proposal did not consider the cost of appreciably alter the report's impact studied was caused by the listed file searches which most be conducted analysis. Since firms would review substance--EPA will make that . by firms which will not actually find newly completed stndies for their effects judgment These changes should cut the ubmittable studies in their file. regardless of this rule, no file retrieval 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 Commenters suggested EPA account far these costs. In the first analysis, EPA attempted to base cost 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 the purposes of a report impact analysis, the previous experience of the prior section 8(d) rule la the firmest estimate that the Agency can utilize. However, EPA has now attempted to estimate costs for those companies that handle the listed substances, but have costs associated with other health and safety studies would be incurred far these new ones. (9) Comments criticized continued reliance on the assumption that 2.6 firms will respond per chemical, which was based on EPA's 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 tiie 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 the 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 8.2 firms association with the chemical by looking three to account for processors asd- reported for the Inventory on chemicals at their current files. This will alleviate a that were listed on the first section 8(d) concern expressed by companies whose A1though some commenters 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 induetry" and average number of sites), whereas only (4) Perhaps the greatest burden cited wou^therefore increase the potential 2.6 firms responded per chemical for the was that of potentially searching every number of processors of the lilted 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 a* Q chemicals on the proposed rule, 1.1 firms worded in this respect The final rule respondents is proper for the following reported for the Inventory. An average contains a section describing the much reasons. First, over 85 percent of the of 23. firms reported for the Inventory on more limited search that will 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. Hub indicated that the comply if they search the files where the chemical, allied products, and Agency's reliance on the 2.8 figure studies are kept in the ordinary course petroleum refining industries. Second, would actually tend to overstate the UCC 006757 i vui. <i/, [mo. 171 / Thursday, September 2, 1982 / Rules and Regulations number of expected respondents for the would not be enough to accommodate (10} Records of all communications present rule. decisions on confidentiality. The between EPA personnel and persons outside (10) Comments were also concerned Agency's estimate of an average of one the Agency pertaining to the development at about the categories of chemicals in the hour review per study is reasonable. this rule. (This does not Include any inter- or rule. They specifically asked for better EPA does not expect that a company intra-agency memoranda unless specifically definitions of the categories or for lists should have to scrutinize a study for noted in the index of the rulemaking record.} of the chemical in the categories for confidential Information just before it is (11) Minutes, summaries, or transcripts of which EPA wants studies. Because of submitted to EPA. Confidential any public meetings held to develop this rule. chemical nomenclature complexities, the information in a study should already (12) Any factual information considered by commenters suggested that die burden have been identified as such by the the Agency in developing the rule. . . of deciding whether a given chemical should be counted in or out could be company. For example, to get a court to X. Regulatory Assessment Requirements prevent disclosure of confidential great . information, a company must be able to EPA has eliminated one of the more ' show that the information was given troublesome categories from the list-- special treatment by the company, Le,, acrylic acid and methylacrylic acid and marked confidential, or kept in limited their esters. In addition, the Agency has access files. Therefore, the Agency given better descriptions and more believes that most of the information in examples to define the categories. EPA a study that is confidential will have believes that these steps, plus the fact been previously identified as such by that the categories now on the rule are the company, and it should not be ones that companies have become necessary to check with virtually every familiar with in following 1TC ' department of the company, as some recommendations for testing, should commenters suggested, to check reduce the dted burden. A company that whether each data element Is. has a question about whether a confidential. particular chemical la included in a Executive Order12291 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 $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 effect on competition, or costs or prices. / This regulation was submitted to the Office of Management and Budget for category should call the information IX. Public Record review as required by Executive Order number given at the beginning of this notice. EPA staff will be available to ' return thete calls and answer questions. ' The basic elements EPA has included In the final Reports Impact Analysis are: (a) Corporate rule review--2 hours at $SO per hour. (b) Corporate identification of pertinent file*-^3 hours at $50 per hour. (c) File search at plant site--6 hours at $30 per hour. (d) Listing study titles--1 hour at $15 per hour. - . EPA has established a public record (docket number OPTS-84003A) for this rulemaking document, which along with a complete index Is available far Inspection in the OPTS Reeding Room, Rm. E-107,401M Street, SW, Washington, DC, 20460, from &00 am to 4:00 pm Monday through Friday, except legal holidays. This record includes basic information considered by the Agency in developing this rule. Following is a'list of the documents 12291. Regulatory Flexibility Act Since this rule was proposed before the effective date of the Regulatory Flexibility Act, 5 UJS.C. 601 et 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 tiie respondents will have gross sales of less than 20 million dollars. (e) Photocopying per study--X hour at which constitute the record for this Paperwork Reduction Act $15 per hour. (f) Final review before submission--1 hour at $50 perhour. rulemaking. Public comments on the Ereposed rule are not individually listed, ut will be available upon request in the Information collection requirements contained in this regulation ($ f 718.6 EPA's estimate of total cost of the rule OPTS reading room. EPA requests that it and 716.7) have been approved by the uses the above figures and assumes that be notified of any additions or deletions Office of Management and Budget 891 firms will perform an initial review, to this record within the next 30 days. (OMB) under the provisions of the 447 firms will submit 3,784 reports of 50 pages each; and each firm has, on a weighted average, 1.5 plant sites. . (1)Health and Safety Study Reporting Regulation!, July 18,1978, Public Record. Docket No. 084001. Paperwork Reduction Act of 1960 U.S.C. 3501 et seq. and have been assigned OMB Control Number 2070-0004. Toe corporate rule review step was (2)Manufacturing Chemist! Association-- This rule requires manufacturers and 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 commenters and the changes EPA has made to rule requirements. One caveat that must be kept in-mind is that these are average costs. Individual firms may experience greater or lesser costs depending on their size. EPA received comment that one hour Petition under section 21 of TSCA, September 12.1978. (3)Denial of Citizens' Petition, 43 FR 56724 56727. (4) The entire docket in Dow Chemical "" Company v. United States Environmental Protection Agency, et al. Docket No. 78-2203 (3rd Cir.J. (5} Revocation of Rule, 44 FR 8099. (6)Reports Impact Analysis 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. (8) General Comments on the Proposed Section 8(d) Rule. ~ (9) All relevant support documents 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 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 40 CFR Part 718 Chemicals, Health and safety, Environmental protection. Hazardous for final review before submission studies. ' 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 John E. Daniel substance produced without a separate Acting Administrator. commercial intent during the Therefore, Chapter I of Title 40 of the Code of Federal Regulations is amended by adding a new part 716 consisting at this time of Subpart A to read as follows: .......... manufacture, processing, use. or disposal of another chemical substance(s) or mixture(s). (b) "Co-product" means a chemical substance produced for e commercial purpose during the manufacture, PART 716--HEALTH AND SAFETY DATA REPORTING processing, use, or disposal of another . chemical substance(s) or mixture(s). (c) "Copy of study" means the written Subpart A--General Provisions ' Ssc. ' ~ 716.1 Scope and compliance. 716J Definition!. 716.4 Overview of subpart requirements. 716.6 Submission of copies of studies. 716.7 Submission of lists of studies. 718JI EPA requests for submission offurther information. presentation of the purpose and methodology of a study and Its results. (d) "EPA" means the United States Environmental Protection .Agency. (e) "Health and safety study" or "study" means any study of any effect of a chemical substance or mixture on health or the environment or on both, including underlying data and 716J) How to report an substances and epidemiological studies, studies of mixtures. occupational exposure to a chemical 716.10 Reporting physical and chemical propertiee. 716.lt Exemptions to reporting requirements. 716.12 File search. 716.14 Reporting schedule. 716.16 Confidentiality claims. 716.17 Substance* and designated mixtures to which this rubpart applies. 716.18 Additions to lists of substances and 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 study included, but other information designated mixtures to which this relating to the effects of a chemical subpart applies. 716.19 Sunset provision. ' Authority: Sec. 6(d), Pub. L 94-466, Slat 2029 (15 UAC 2607(f)]. substance or mixture on health or the environment is also included. Any data that bear on the effects of a chemical substance on health or the environment Subpart A--General Provisions would be included. Chemical identity is part of, or underlying data, to, a health 1716.1 Scope and comptance. (a) This Subpart sets forth _----- requirements for the submission of lists and copies of health and safety studies on chemical substances 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. (2) Examples are: (i) Long- and short-term tests of mutagenicity, carcinogenicity, or teratogenicity; data on behavioral disorders: derma toxicity; pharmacological effects; mammalian absorption, distribution, metabolism, and excretion; cumulative, additive, and synergistic effects; and acute, subchronic, and 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 a behavioral tests, algal growth tests, seed violation of section 15 renders a person liable to the United States for a dvil S[nation plant flmwtfc nr ige tests, microbial function tests, penalty and possible criminal bioconcentfation or bioaccuroulation . prosecution. Under section 17, the tests, and model ecosystem (microcosm) district courts of the United States have studies. jurisdiction to restrain any violation of (Oil Assessments of human and section 15. environmental exposure, including f 716.3 DefinftkMM. 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 Subpart 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 relationships; air. water, and soil transport; Biomagnification and bioconcentration; and chemical and physical properties, e.g., boiling point vapor pressure, evaporation rates from soil and water, octanol/water partition coefficient and water solubility, ~' fivl Monitoring data, when they have been aggregated and analyzed to measureffiiTexposure 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 19 CFR l.n). 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 19 CFR 141.20. (4) The transferee, if the right to draw merchandise in a bonded warehouse has been tranferred in accordance with Subpart C of 19 CFR Part 144. For 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 a 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. (U) For use by the manufacturer, including use for product research and development or as 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 / Vol. 47, No. 171 / Tliursday, September 2, 1982 / Rules and Regulations value. They are nonetheless produced must be submitted within 60 days after 4 716.6 Submission of copies of itudfoa. for the purpose of obtaining a the addition of the substance or (a) (1) Except as provided in 4 5 716.10 commercial advantage since they are designated mixture to { 716.17, and 718.11, persons 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. (j) "Person" includes any individual, firm, company, corporation, jointventure, partnership, sole proprietorship, studies that are ongoing when the substance or designated mixture is added to f 716.17. Hie list must be submitted within 60 days after the in their possession for the substances or designated mixtures listed in 4 716.17. Persons are responsible for submitting copies on only the substances or -- association, or any other business addition of the substance or designated designated mixtures which they have entity, any State or political subdivision mixture to 4 718.17 and copies of such manufactured or processed 'or ftroposed thereof, any municipality, any interstate studies must be submitted within 30 to manufacture or process (including as body, and any department, agency, or days of their completion under 716.14. known byproducts) within the ten years Instrumentality of the Federal (iii) Inform EPA within 30 days of any 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 rmeans the preparation of a chemical submit a copy of the study when it is ongoing under 4 716.7(a)(1) must submit substance or mixture, after its completed. Hiis requirement continues them when they are completed. I I manufacture, for distribution in until the sunset date specified in | commerce with the purpose of obtainfin7g16.19; it applies not only to persons ,1 an immediate or eventual commerciwalho manufacture or process a substance advantage for the processor. Processing or designated mixture when it is added of any amount of a chemical substance to the list, but also to persons who begin or mixture is included. If a chemical to manufacture or process, or propose to substance or mixture containing . do so at any time prior to the sunset impurities is processed for commercial purposes, then those impurities are also date. (2)A person who is not covered under processed for commercial purposes. paragraph (b)(1) of this section, but has (1) "Propose to manufacture, process, or distribute" means 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" means "chemical substance" as defined at section 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 et seq. manufactured or processed a substance or designated mixture listed in | 716.17. or has proposed to do so, anytime in the preceding ten yean, must submit copies of studies in his possession on the substance or designated mixture within 60 days of when it is added to f 716.17. (c) Studies to be reported. Ingeneraj.(% studies, as defined at 4 718J(dCthatare unpublished are reportable, Le- must be submitted or listed, far any substance or designated mixture listed in j 716.17. - ) (2) Underlying data, such as medical or health records, individual files, lab notebooks, and daily monitoring records supporting studies, do not have to be submitted initially. EPA may request underlying data latefunder 716.8, (b) Submissions under paragraph (a) of this section past be indexed by chemical name, including CAS number if known, and must be accompanied by a cover letter containing the name, job 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, in the cover letter, respondents must identify any impurity or additive known to have been present in the substance as studied unless its presence is specifically noted in the study itself. (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 the be submitted, preferably by certified requirements. For additional procedures 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 206a - 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 listed in 1716.10 must be 4716.7 Submission of lists of studies. are not required to search any records submitted (a) Except as provided in 4 4 716.10 retired prior to December 31.1979 for (2) Studies of mixtures known to and 716.11, persons must send the lists information to comply with this subpart contain substances or designated described in paragraphs (a) (1) and (2) of In addition, the scope of a company's mixtures listed in i 716.17 are reportable this section to EPA for each of the responsibility to search records is except for studies of physical and substances or designated mixtures listed limited to records in which it ordinarily chemical properties and the studies in 4 716.17 which they manufacture or keeps the required information and to exempted at 1716.11(f) (1) through (6). 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 tile health and ft--- is reporting has manufactmvd or (1) A list of ongoing health and safety environmental effects of chemicals processed or proposed to manufacture studies being conducted for or initiated under 4 716.12. or process only as Impurities are not by them, noting for each entry the (b) Persons who must report (1) A generally reportable under S 718.11 (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 are not reportable under { 716.11(e). by 4 716.19. Studies initiated after the for that substance or designated (5) Underlying data, such as medical initial 60 day reporting period must be mixture--(ij Submit copies of all non- or health records 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 he becomes subject to the rule are not reportable except by special short-term tests or mutagenicity, under 4 716.6. Under { 716.14 the copies request under 4 716.0. " carcinogenicity or teratogenicity; and UCC 006760 Federal Register / Vol. 47, No. 171 / Thursday, September* 2, 1982 / Rules and Regulations 38793 the biological and environmental fate (c) Studies of the following (1) Acute oral toxicity studies. testa listed in { 718.10 (h) through (j). preparations of a aubstance must be (2) Acute dermal toxicity studies. (2) A list of unpublished studies reported as studies of the substance (3) Acute inhalation toxicity studies. known to them of which they do not itself, not as studies of mixtures known (4) Primary eye irritation studies. have copies! The name and address of any person known to them to possess a copy of the unpublished study must accompany each entry on thejist 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 { 718.12. fb) 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, |ob 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 aafety studies should be submitted, preferably by certified mail, to: U.S. Environmental Protection Agency, TSCA-8D1, P.O. Box 2080, Rockville, Maryland 20852. 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 the integrity or physical form of the substance. (3) The substance at any grade of purity. 1716.10 Reporting physical and chamical properties. - Studies ofphysical and chemical properties must be reported under this subpart if performed for thepurpose of determining the environmental or BToiogical fate of a substance, and only ti thev investigated one or more of the following properties: (a) water solubility. (b) Adsoiption/desorption on particulate surfaces, e.g., soiL (c) Vapor pressure. (d) Octanol/water partition (5) Primary dermal irritation studies. (6) Dermal sensitization studies. (7) Physical and chemical properties. If the substance or designated mixture is an impurity, no reporting is required [see 1 716.11(1), below). ' (g) Analyzed aggregations of monitoring data based on monitoring data acquired more .than five ears Sreceding the date the'substance or esignated mixture was added to the list in 1 718.17. . (h) Analyzed aggregations of monitoring data nn mixhiree known to contain one or more substance or . designate^ mixtures listed in 1718.17, when the monitoring data are not analyzed to determine the exposure or concentration levels of the substances or designated mixture listed in { 716.17. (i) Studies on a substance or designated mixture listed in 1 718.17 that the person who is reporting has manufactured or processed or proposed f 716.8 EPA requests for submission of further Information. coefficient (a) Density/relative density (specific to manufacture or process only as an impurity. When reporting of such studies EPA may request the following submissions after the Initial reporting under |f 716.8 and 716.7. If the requested submissions are not made, EPA may subpoena them under section 11 of TSCA. 15 U.S.C. 2810. (a] Submission of underlying data of the kind described in { 716.6(a)(2} by persons who submit copies of studies under f 718.8 or list studies under | 718.7(a)(1). . (b) Submission of preliminary reports of ongoing studies by persons who list the studies under S 716.7(a)(1). 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. (j) Degradation by biological . mechanisms--aerobic and anaerobic. (716.11 Exemptions to reportlnfl requirements. The following are exempt from the Is to be required, that reporting will be separately proposed in the Federal Register. 1716.12 Ffle search. 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 the ordinary course of their business, and to information kept by employees whose assigned duty is to advise the company on the health or environmental effects of chemicals. For purposes of this rule, persona do not (c) Submission of copies of studies by copy and list submission requirements have to search files retired prior to persons listed under 716.7(a)(2) as of H 716.8 and 718.7. December 31,1979. ' possessing them. 1716.8 How to report on substances and mixture*. . Section 716.17 contains two lists, one of substances and one of designated mixtures. Studies of listed substances and designated mixtures shall be (a) Studies which have been published in the scientific literature. (b) Studies previously submitted to EPA, e.g,, studies voluntarily submitted during section 4 proceedings or under the previous section 8(d) rule. / (c) Studies previously submitted to ,/any Federal agency with no claims of ( 716.14 Reporting schedule. (a) Except as provided in paragraphs (b) and (c) of this section, submissions under $$ 718.8 and 716.7 must be postmarked on or before 80 days after the effective date of the luting of a substance or designated mixture in reported a# follows: confidentiality. 1718.17 or within 60 days of proposing ' (a) When a substance is individually \\. f (d) Studies conducted or initiated by to manufacture or process a substance listed under 1 716.17(a), studies of the \q(hr for another person who Is subject to or designated mixture if first done after substance and studies of mixtures \ v ! 1 716.6 and 716.7. the effective date of the substance's or known to contain the substance must be (e) Studies of chemical substances designated mixture's listing in ( 716.17. reported as studies of that substance. which are not on the TSCA Chemical (b) Persons subject to the listing (b) When two or more substances are Substance Inventory, e.g,, research,and requirement of 1 716.7 must inform EPA listed as a designated mixture under development studies on new chemical of any study initiated by or for them { 718.17(b), studies of the designated substances? within the three-year reporting period mixture and studies of any mixture (f) The following types of studies described in ] 716.19 within 30 days of known to contain the designated when the subject of the study is a Initiation of the study. Copies of studies mixture must be reported as studies of mixture known to contain a substance listed as ongoing under S 718.7(a)(1), or the designated mixture. or designated mixture listed in S 716,17. 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) Respondents 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. 20460, Attn: Section 8(d) extension. f 716.16 Confidentiality eMma. (a) Any person submitting a document under this Subpart may assert a business confidentiality claim covering all 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 at 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) of TSCA states that ERA may not withhold from disclosure, on the grounds that they are confidential business Information, health and 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 is required under TSCA section 5, except to the extent that disclosure of data from such studies would reveal: (1) processes used in die (1)One copy must be complete. In that manufacturing or processing of a copy, the respondent must indicate what substance or mixture, or (fl) the portion of a mixture comprised by any of the substance* 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 the claim, Le., by saying "reveals confidential process information'* or "reveals confidential mixture proportion data," and dearly identify the material subject to the claim. Information in a study, such as company name or address, financial statistics, or product codes used by a 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 the basis of the claim. ' (2) If some data are daimed as confidential the respondent must - - submit a second copy. The second copy must be complete, except that all information daimed 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 is daimed as confidential in the first copy will be company, which is irrelevant to any health or environmental effect of a considered a presumptive waiver of the rlalni of confidentiality. EPA will notify chemical may be claimed confidential the respondent by certified mail that a and not subject to the disclosure finding of a presumptive waiver of the requirements of section 14(b) of TSCA. daim of confidentiality has been made. Other information contained In a study, the dlsdosuie of which would dearly be an unwarranted invasion of personal privacy (such as individual medical records), will be considered confidential as provided in Title 5. United States The respondent wilt be given 30 days from the date of receipt of notification to submit the required second copy. If the respondent falls to submit the second copy within the 30 days EPA will place file first copy in the public file. Code, section 552(b)(8). 1716.17 Substances and designated (d) To assert a daim of confidentiality mixtures to which this subpart applies. for data.contained in a submitted (a)(1) Substances. The following document, the respondent must submit substances are subject to this subpart as two copies of the document of October 4,1882. 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 H or alkyl r2 H or alkyl R3 * H or alkyl r4 * H or alkyl Groups Ri-R4 may contain one or more epoxide functions i UCC 006762 Federal Register / Vol. 47, No. 171 / Thursday, September 2,1982 / Rules and Regulations Substances __ CAS Numbers (examples> for groups) Alkyl phthalates -- all alkyl esters of 1,2-benzene dicarboxylic acid (orthophthalic acid). o If --o r, --O--ft- &2 Ri alkyl R2 - alkyl : ..... ........ ........ 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 *...... / Aniline and chloro-, bromo-. and/or nitro-aniline3. -- r- . * 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 . Antimony. 7440 -36-0 1 VO 1 Antimony trioxide. 1309 Antimony sulfide. 1345--04-6 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. /O 8 i o=pe-oR, 3 78-30-8 78-32-0 78-33-1 115-86-6 563-04-2 . 1241-94-7 1330-78-5 2528-36-1 25155-23-1 26444-49-5 28108-99-8 29761-21-5 51363-64-5 56803-37-3 38795 " . UCC 006763 38796 Federal Register / Vol. 47, No. 171 / Thursday, September 2,1982 / Rales and Regulations ' Substances CAS Numbers (examples for groups) 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 (cummingtonite- i grunerite); anthophyllite; tremolite; *and actinolite. . 1332- 21-4 / 12001 -29-5 ' 12172 -73-5 17068 -78-9 , Bisazobiphenyl dyes derived from ' | benzidine and its congeners. orthotolidine (dimethylbenzidine) and dianisidine (dimethoxybenzidine). -' ,% - - ~ . < T t J' -- : | 1f -' . - , 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 Chlorinated benzenes, mono- and di-. `- . ' 95-50-1 106-46-7 108-90-7 541-73-1 Chlorinated benzenes, tri-, tetra- and penta- 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 / Rules and Regulations 38797 Substances . Chlorinated naphthalenes -- chlorinated derivatives of naphthalene (empirical formula c10Bxcly` where ) I 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, raeta-, and para-cresol. Cyclohexanone. Dichioromethane. (methylene chloride) 1,2-DichlOropropane. Glycidol and its derivatives. H- R H; alkyl, alkenyl or alkynyl; aryl; acyl fthere R " alkyl, alkenyl, alkynyl, aryl, or acyl; any substituents or functional groups may be present with the alkyl, etc., groups. CAS Numbers (examples tor 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 jffijjL Federal Register / Vol. 47, No. 171 / Thursday. September 2,1982 / Rules and Regulations Substances Halogenated alkyl epoxides -- halogenated noncyclic ali phatic hydrocarbons with one or more epoxy functional groups. ' CAS Numbers (examples for groups) 106-89-8 428-59-1 3083-25-8 3132-64-7 R'Y--^/Rs ft/ Rx R2 - R] R4 - Xor CnH2n+i-y*y (y"l to 2n+l> Hor X or CnHjn+i.yXy (y-0 to 2n+l) Uor X or cnH2n+l-yxy *y* to 2n+1* aor X or CnH2n+l.yXy (y-0 to 2n+l) X halogen Groups R> - r. may contain one or more :; 4i epoxide functions. * : i hexachloro-lf 3-butadiene. 87-68-3 Uexachlorocyclopentadiene. 77-47-4 dydroquinone. - Isophorone. Mesityl oxide. 4,4*-Methylenedianiline. Methyl ethyl ketone. Methyl isobutyl ketone* r Nitrobenzene. ` \ p-Phenylenediamine. Polychlorinated terphenyls --polychlorinated ortho-, meta-, and para-terphenyls* Pyridine. - 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 Ouinone. Toluene. 106-51-4 108-88-3 1,1,1-Trichloroethane (methyl chloroform). 71-55-6 vinyl fluoride. vinylidene fluoride. 75-02-5 75-38-7 Xylenes -- ortho-, meta-, and para-xylene. 95-47-6 106-42-3 * 108-38-3 (2) (Reserved] (b) (Reserved] MUJM COOS MMK UCC 006766 t j. ' ; ______ Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations 38799 f 71111 Additions to lists of substances and designated mixtures to which this subpart applies. The requirements of this Subpart will periodically be extended to cover additional substances and designated mixtures. Two procedures will be used to add substancea.and mixtures. (a) Except as provided in paragraph (b) of this section, substances and designated mixtures will be added after publication in the Federal Register of a notice of proposed amendment of this . subpart There will be a 30-day public comment period on the notice; after consideration of the comments, a final amendment will identify the substances and mixtures added. (b} Substances and designated mixtures that have been recommended for testing by the Interagency Testing Committee, established under section 4 of TSCA, will become subject to this . subpart 30 days after publication of a notice-to that effect in the Federal Register. f 714.19 Sunset provision. . Tile reporting period on a~ substance or designated mixture will terminate no - later than three years after diet substance or designated mixture is added to the list in ! 710.17. The automatic termination date for the three year reporting period on a substance or mixture will be the annual sunset date (May 1 or November 1) that falls 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 substances and designated mixtures listed in 9 716.17 (a) and (b). An earlier termination date may be published for a substance or designated mixture at the discretion of tiie Assistant Administrator for Pesticides and Toxic Substances. p* Dm. SMMMIU S-1-SS MS *| MLUNft COM MMHI 1 UCC 006767 38800 Federal Register ] VoL 47, No. 171 / Thursday, September 2, 1982 / Proposed Rules ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 716 [OPTS-*40036; TSH-fBL Ml*-*] Health and Safety Data Reporting Submission of-List* and Coplea of Health and Safety Studies . AGENCY; Environmental Protection Agency (EPA). action: Proposed rule.' SUMMARY: Thi* 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 the Toxic Substances Control Act (TSCA), 15 U.S.C. 2607(d) (40 CFR Part 716 Subpart A). The chemical substances proposed to be added were recommended for testing by the Interagency Testing Committee (ITC), in their sixth through tenth reports to EPA (45 FR 35897, 45 FR 78432, 46 FR 28138, 47 PR 5456, and 47 FR 22585). The ITC was established under section 4 of TSCA. DATE Comments must be submitted on or before October 4,1982. aooress: Written comments should bear the document control number OPTS-64003B and should be submitted to; Document Control Officer (TS-793), Office of Pesticides and Toxic Substances, Environmental Protection Agency, Room E-409,401M St, SW,, Washington. D.C. 20460. All written comments filed under this notice will be available.for public inspection in Rm. E-107 from 8:00 a.m. to 400 p.ra. Monday through Friday, except legal holidays. FOR FURTHER INFORMATION CONTACT: Douglas Bannerman, Acting Director, Industry Assistance Office (TS-799), Office of Toxic Substances, Environmental Protection Agency, Rm. E-511,401M SL, SW.. Washington, D.C. 20460, Toll free: (800-424-0065); in Washington, D.C.: (554-1404); Outside - the U.S.A.: (Operator-202-554-1404). 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 proposal EPA would amend the list of chemicals by adding the chemicals recommended for testing by the ITC in Its sixth through tenth reports. Comments are solicited on this amendment In the future, ell ITCrecommended chemicals will be subject to the rule effective 30 days after publication of a notice in the Federal Register to that effect (See 40 CFR 718.18.) We propose to add the following chemical substances and categories of chemical substances to 40 CFR 716.17. The ITC report number in which the recommendation was made follows each chemical substance or category of substances listed-below. Chamleal* Proposed for Addition to Rule Categoriet ofChemical Substances Phenylenediamines--6th Report Fluaroalkenes--7th Report Chemical Substanaee Benzyl butyl phthalate--7th Report Biphenyl--10th Report Butyl glycoiyl butyl phthalste--7th Report Chlorendlc add--Oth Report 4-ChloiobenzotrifIuoride--Oth Report 2-Chlorotoluene--8th Report ' Diethylenetrlamine--8th Report Etbyltoiuene--loth Report Formamide--10th Report Hexachloroethane--8th Report L2,4-Ttlmethylbenzene--10th Report Trie (2-ChJoroethyl) phosphite--Oth Report Under the rule implementing section 8(d) of TSCA, EPA will acquire unpublished health and safety studies on these chemicals from manufacturers and processors of the chemicals. Hie Agency will use the studies to support its investigations of the risks posed by the chemicals and, in particular, to support its decisions whether to require industry to test chemicals under section 4 of TSCA. Use of the studies in this 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 rule. -' Economic Impact EPA estimates that these additional chemicals will cost industry $195,000 to submit the required data. Hiis consists of the following: Corporals Awls Rswfsv unpom i mm (m fliMi a josn.s...nossovt)--m,_. ____ TWt **"0 * .. . .. , Total tatooo 2&000 ss.noo snm A/Wrt 13,(1(10 TinftO 10.000 It&OOO If we assume 30 percent margin of error in these estimates the range of probable oost varies from $136,000 to $254,000. Public Record EPA has established s public record (docket number OPTS-84003B) for this proposed rulemaking document which, along with a complete index, is available for inspection in Rm. E-107 from 64)0 am to 44)0 pm on working days (401M Street, SW., Washington. D.C, 20460). This record includes basic information considered by the Agency in developing this proposed rule. The Agency will supplement the record with additional information as it is-received. The record includes the following categories of Information: (1] Health and Safety Study Reporting Regulations (40 CFR Pert 716), Public Record, Docket No. 084003. , (2) Reports Impact Analysis for 40 CFR Part 718 and this proposed rulemaking. (3) 6th-10th Reports of the Interagency Testing Committee (ITC); 45 FR 35897 [6th Report), 45 FR 78432 (7th Report). 46 FR 28136 (8th Report), 47 FR 5456 (Oth Report), and 47 FR 22585 (10th Report). EPA anticipates adding to the rulemaking record the following types of information: (1) AU comments on this proposed amendment. - (2) All relevant support documents and studies. (3) Records of all communications between EPA personnel and persona outside the Agency pertaining to the development of this rule. (This does not include any inter- 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 rule. (8) Comments received from OMB under the Paperwork Reduction Act. EPA will identify the complete rulemaking record on or before the date of promulgation of the regulation, as prescribed by section 19(a)(3) of TSCA, and will accept additional material for inclusion in the record at any time between this notice and such designation. The final rule will also permit persons to point out any errors or omissions in the record. Regulatory Assessment Requirements; Paperwork Reduction Act The reporting provisions of the final section 6(d) rule have been submitted for approval to the Office of Management and Budget (OMB) under section 3504(b) of the Paperwork Reduction Act of 1980 U.S.C. 3501 et seq. The final rule will explain how its UCC 006768 i Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Proposed Rules 38801 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. Regulatory Flexibility Act This rule (amendment), if promulgated, will not have a significant economic impact on a substantial 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 $20 million. Further, approximately 90 percent are expected to have gross sales over $100 million. Thus, of the approximately 172 companies expected to report under this rule, 156 are expected to have sales greater than $100 million. Only two companies are expected to have gross sales under $20 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 substantial number of small entities. v 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 $100 million or more on the economy. It is expected to have a one-time cost of about $195,000. It does not have a significant effect on competition, costs or prices. 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 716 Chemicals, Health and safety. Environmental protection, Hazardous materials. Recordkeeping and reporting. Dated: August 23,1982. John E. Daniel, Acting Adminittrator. PART 716--HEALTH AND SAFETY DATA REPORTING Therefore, it is proposed that Title 40, Chapter L be amended by adding S 716.17(a)(2) to read as follows: S 716to17 Subttancas and designated mixtum to which subpwl appttaa. [)** (2) As of the date of publication of the final rule (amendment) in the Federal Register, die following chemical substances are subject to this subpart my* g*ypny M/i phWiel-- ALImuJ. - * 4 1 I'Oiii nb |4to----1--- trtd'W'trt'fnr ? *3-53-4 .. 06-70.1 tS-40-0 111-aO-O 25550-14-5 TNs otegny is dvflnstf m iluondhMi of * gananf tarmuto: CUf.-J', atom n aquaia 2 or 3 and aqua* l Id a Thto natagwy tocfudaa tha toSowfn* ato towroatoanaa bid to not tora--d to Slant TaaaOuoroathana____-- . Tntomroatoana am*-y-mv-mn---t -------- - -- r--fip' D--U-Dn- O- I ^ - ....... ...... II mO I n mpay Timininiii.aiilMH.nl Thto caaagoy to daHnad aa a* mubadwad phanytondtontoaa and I 110-14-1 350-11-5 75-30-7 75-03-0 110-15-4 577-31-4 70-13-7 67-73-1 SubvtmoM CAS mantoan of tha group of fiafo, ntoo, hyAny, hydrtny-towar atony. toaiar-atoyt, and tour llimy. For thto purpoaa. tho tom "tawor" to dallnad at a ywa> con- .--i category tactodss tha totaling yandamnw but is not Smftad to 0-OMnebsnnrte------------------------2,8-dtefnlnotoluana, liS^Xsntone^rrAiyltenaafte.^ o rtwnytendtemina, 4-crtofO"-- o PhanytermjMnifte. 4-nteo^_ --* -- SAnumhifiifitmM ,vuwiwijpn6ra umyuiuunwnnp., IJ-Otofftou t iMtehytmi-- ^Ptwnytenadtonvnoniufn dfcfttorW** tFhsnjitonadtaNMte, i-Phanytonadtafntato, 4-nwthoicy, <*V i Phan^Mtedtowina. 4*faathoy,, Igg'FttonyteftodiafTiina JhyteucNortda^ -... ....1,-Oarttanadtemlna. Wiydrocft- p4nafy6n$a(iflwis a^$BO>s,i ^s^fvOCak XSOtorntocMuana aidtola________ pPhanytonacianana. dtoydracNoitdt2-Dtornino-1-malhy4banrana_______ o Pfian)taiiaJtonana, 4athoay. 1,3Ctow*to-S-imfhytoarrana_______ ~ ' _ ' . auutof-_____ iSaitoo- > PtwtUftonadtonana. toaMro. m-Phanylanadtonana, 4-ehton>-_ pOtomfnoartoola. p-Phanyfanartamlna. 3-ntoo_. m-Phanyfanadtomato. taWo-. p-Phanytanadtofltoia. 3-ntoo-o-PhanytanaJaiiana. 4-ntotv. lASannnadtonifna, a--alfi)f% Jhydmch- 5-64-5 96-70-5 95-69*7 96-63-0 99-56-0 106-60-3 106-46-? 108-71-4 137-00-? 499-72-b 641-99-5 641-70-9 814-94-9 916-06-4 916-28-1 615-43-2 615-46-3 515-504) U4-1t4 523-40-5 11*7-37.1 3557-35-4 3563-33-8 5043-55-7 5131-SS-S 5131-60-2 5307-03-8 5307-14-3 S31S-S7-S S31S-71-3 6310-77-S 4T6JtonyiiH n "isant -------- f 15S72-73-S 15346-77-0 p PhanjtonaJiniina. Mtop, <i(dai5 IwMo 1S20S-53-S 30103-00-7 2S37S-45-5 3,4-Otomfnoantooft auSato ' 30155-41-7 1^-Sanxanailantoia. 54fitoi4-nfbs 42380-30-0 1.4-Banranadtomina, atoanadtoato (1:1) -- 53664-17-5 4.6-Oian*no-3-rna<fTytoharxif. hyrohfuldi___ 56S70-44-S Ethanol. 2-<2.4-<*anynophano*y-, dtoy- 5433-05-5 1J-OamanaJanana. 4 atomy-, afw (1:11----------------------------------------- m-Thanytonadtomina. 4-chtore-. aidfata-- 1j-BanianadtoMna, 4-naro-, aullato (1:1)_ 1.4-eanzanadamaia. 2-ntti>-, auaaaa (i:i)_ 1,2-flanzanadtomlna. 4-cNora, auKata (1:11----------------------------------------- 1,3 Oantanadtonana. ar-adiyl nwtbyf--. 1,3.4-TrimMhytoamana /Tito (3-CWuiuaSiyO phoaphtoa____________ 67801-4)6-3 68015-86-5 55338-50-5 55330-53-7 SS230-S3-S 85158 80 3 88036-34-7 95-53-5 1*0-05-8 / ***** IP* Doc. 18-3406* FOad O-l-tt M5 as) eajjsm com osso-so-m UCC 006769 INTERNAL CORRESPONDENCE UNION CARBIDE CORPORATION old ridgebury road, danbury, ct dbbi7 To (NemeJ Mr. W. J. Hansen Division Mr. W. E. Whitehurst Location Ares Copy to Mr. J. H. Barrett Mr. T. L. Collins Mr. R. A. Matthews . Date October 21, 1982 Originating Dept- HS & EA Aree 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) / - 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 Ci C - 0 -/ uJ^ OcPT * / r!H Rtf rj^ CONSTRUCTION SAFETY OEPARtfjENT TRAINING RECORD Type of Training Date Instructor 7J i JO -S ^77 NAME EMPLOYEE NO. i. .jiy^ - .2 $1 Xpuif&rztf,. -- .jo27 3. Jai/ooi &02-1 a. rOan/>cfs\ 802fi 5 . / ~^3 3lP^ 6. 7 8. 9. 10. 11 . I 2. i1h ' Jl nr ^CZi> jLzlJl. 1 3. 1 it. 1 5. 1 6. I 7. 1 8. t 9. 20. 2 t. 2 2. 2 3. 2 A. 2 5. CRAFT ISOLL ?s-3f Z?>< 3 c: ^ UCC 006773 SUPERVISOR -k_0L-^d &y/l*fo ^ f7. /&><!?</ i ii PRACTICES AND PROCEDURES IN ASBESTOS CONTROL UNION CARBIDE, Charleston, WV April 8, 1987 AE75580 SIGN-IN SHEET NAME (please print) ) SOC SBC # SIGNATURE 1. /T SAmSSq/iJ 223-{y-3(/9JL .2 J36`9,9,-7631 y 3. ffrUfi......^ r<< JL33sS.Q~J.3l3., 4. 1`pgtfgric.k '~R Cft ________ 3-^G' %) ''rZ2^ ^ 6uxJ! 5. Ookva___Wi. .Gl&C_______ 73*f-%%- Ql 14- .6 R .E , Rc^;a^s_________________ ^33-Go-.. 7*110 \lflh><ie. . ^ONlev' 7. \.J(UajCS - 9. .10 Af/ rm/L**7. .11 ffiherT F T7ry/____________ llSVZS^Y 12. 13. 14. 15. 16. 17. 18. 19. 20. /2^QCtS UCC 006774 PRACTICES AND PROCEDURES IN ASBESTOS CONTROL UNION CARBIDE, CHARLESTON, WV April 8, 1987 AE75580 SIGN-IN SHEET NAME (please print) 1. J^ouJSrJ. rtf) Its 2. Ht-feiO C . ??/'es; 3 / t- vS U n JP.i' 1(3 s^l 4. //[ U, 5. IiJA, j._ SOC SBC # fP 2WK -s m SIGNATURE 3)Ajaafc-foL, ^-<55-3305. pAP/< y V-cf________________U___m___o___m___T_1/3,(\ { 6. JoA/a) <Jo7?72/= 7. ?0. /ScPA 8. ^tLmAjiS<XC- 9. Q.&> Ch/t/nJjLs 3ZC.- 3-*>-? 9 J-IZ' 7/'/?^ 3 S2 -<t<J~QSK 9 2.32-XC- ?S51 (3`3 - 10* /S. >,, stirJG ii. C. aA**** Z1Z -G'4-90$2> Z3Y~ 90'/X/J 12. RT 13. fin ' 14. 232 - 70 - 97/0 ic? Zt.2 - H' AH n sry?}JA / /" s s 15. 16. 17. 18. 19. 20. UCC 006775