Document 5LJXRyGBwzM4drzxY0edMY09R

/.X A/C Pipe Producers Association {/- // Executive Committee to International Affairs Committee .. "'X\-X' \ ..... , ^ ,r-f: y/zeJx.... ......... -- f<^/J.F. Welch, Vice President X^ />n-^ r'<- vA'/ Internol Correspondence A. 0AIESeptember 3,1982 subject u.S. Environmental Protection Agency (EPA) - Section 8 (d), Toxic Substances Control' Act (TSCA) REF: JFW correspondence, EPA-Proposed Rule on Submission of Health and Safety Studies, January 4,1980 ACTION REQUIRED: Review for information BACKGROUND Section 8 (d) of TSCA authorizes the Administrator to promulgate rules requiring manufacturers, processors and distributors to submit lists and copies of health and safety studies on chemical substances or mixtures. EPA would use these studies to assess health and environmental effects of chemicals and the need for and character of testing rules promulgated under Section 4 (a) of TSCA. On December 31, 1979, EPA proposed such rules and listed asbestos, among other chemicals, as a substance for which unpublished studies should be gathered. CURRENT STATUS On September 2, 1982, EPA issued a final rule requiring submission of unpublished health and safety studies and lists of studies on asbestos and a number of other chemicals. As of October 4, 1982, all commercial forms of asbestos and mixtures containing asbestos are subject to the enclosed regulations. Lists and copies of studies must be submitted no later than sixty (60) days after October 4, 1982. COMPARISON T71TH 1979 PROPOSED RUI.E In contrast to the proposal, the final rule states "...respondents are responsible for searching only the company files in which they ordinarily keep studies and records kept by employees whose assigned duty is to advise the company on health and environmental effects of chemicals... ." Respondents need not consult any records retired prior to December 31, 1979. Distributors are exempted from the reporting requirements. HEALTH AND SAFETY STUDY DEFINED The term "health and safety study" is broadly interpreted to mean "any study of any effect of a chemical substance or mixture on health or the environment or on both, including underlying data and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, toxicological, clinical and ecological or other studies... ." Virtually any data that bear on health and environmental effects, including studies of air, water and soil transport of asbestos, fall withi the meaning of the term. CAPCO JEN 0012311 When a substance such as asbestos is individually listed, studies of mixtures known to contain asbestos must be reported as studies of asbestos. STAFF ANALYSIS The AACPP report on asbestos exposures during the cutting and machining of A/C pipe should not be subject to the reporting requirements because it was published in whole or in part in a number of AACPP publications or position statements. However, the results of TAC-01-80, "Recommended Work Practices Phase 2: Transient Asbestos," may be subject to the reporting requirements because it could be construed to be an assessment of "human and environmental exposure...including surveys, tests and studies of...air, water and soil transport" of asbestos. This matter will be discussed with Kirkland & Ellis and AACPP counsel, and appropriate action taken. If you have any questions, please do not hesitate to call. JFW/ccw cc: A. Kahn, Esq. Tim Hardy, Esq. copies: Executive Committee L. Ambler L. Taylor J. Cran International Affairs Committee E. van der Rest S. Al-Tarkait R. Dorner M. Delcourt L. Giannitrapani J. Cuvelier P. Hart B. Giboin A. Saoulis G. Zaviezo R. Jalan J. Schmaus V. Pattabhi J. Rodrigues H. Hudson C. Barton Dubuc Pimatit 0172090801 Chrono > CAPCO JEN 0012312 38.780 . Federal Register / Vol. 47, No. 171 / Thursday, September 2,1982 / Rules and Regulations ' ferVIROriMENTAL PROTECTION AGENCY AO CFR Part 718 IOPTS-34C03A; 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 of unpublished health and safety studies on specifically listed chemicals by chemical manufacturers, processors, and others in possession of such studies. The rule is issued under section 8(d) of the Toxic Substances Control Act (TSCA). 15 U.S.C. 2607(d). The Administrator will issue amendments in the Federal Register to add to the list of chemicals subject to the rule. Amendments to add chemicals recommended for testing by the Interagency Testing Committee (1TC), 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 Bannerman, Acting Director, Industry Assistance Office (TS-799), Office of Toxic Substances, Environmental Protection Agency. Rm. E-511,401 M Street, SW., Washington, DC 20460; toll free (800-424-9065): in Washington. DC (554-1404); outside the DSA (Operator-202-554-1404). SUPPLEMENTARY INFORMATION: OMB Control Number: 2070-0004. Background In the Federal Register of July 18,1978 143 FR 30984), EPA promulgated a previous version of this rule under section 8(d) of 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. 605 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 tin a chemical from companies that do not manufacture, process or distribute that chemical. The Court upheld EPA's The proposal spoke of information authority for both provisions. "known to" or in the "possession" of Purpose and Use of the Rule respondents. The definitions given for these terms were broad, and comments Under this rule. EPA wilt acquire indicated that, under these definitions, unpublished health and safety studies companies would feel obliged to search on specified chemicals from manufacturers and processors of the chemicals. The Agency will use the many more records than we believe . necessary. We have decided to replace the definitions with a description of the studies to support its investigations of scope of a search that wilt be adequate .the risks posed by chemicals and, in for this rule. The rule now says that particular, to support its decisions respondents are responsible for whether to require industry to test searching only the company files in ' chemicals under section 4 of TSCA. The which they ordinarily keep studies and addition of chemicals to the rule will the records kept by employees whose - occur by notice of amendment in the assigned duty is to advise the company Federal Register. In the case of ' ' . on health and environmental effects of-' chemicals recommended for testing by . chemicals. Moreover, for all compliance' the ITC, the amendment will be effective purposes, respondents need not consult thirty days after publication._For other any records that they retired prior to ' chemicals, the amendment will He ' December 31,1979, the date on which ` subject"to a tHfriy-day^uHlicconyiient^ this rule was proposed. period SefoTjjSmuJga lion. Studles of health ancTenvironmental effects, including studies of exposures of people or the environment, are the fundamental ingredients of any assessment of chemical risk. For this reason, EPA will require reporting under this rule for specific chemicals that are under investigation either in early stages of risk assessment or when action to control exposure is being considered. Furthermore, EPA expects to require submission of unpublished health and safety studies for all chemicals under consideration for required testing under section 4 of TSCA. EPA will evaluate the studies reported under this rule together with other available data to construct a picture of the effects of chemicals and their associated risks. The studies submitted under the previously issued section 3(d) rule (43 FR 30984, July 18,1978). have been very The rule has two basic requirements: Submission ofcopies 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 useful in the Agency's investigation of for the chemical (three years after the the effects of the ITC-recommanded chemical is made subject to the rule) to chemicals covered by that rule. The cover studies begun during that period, studies have been used in designing appropriate tests, and in support of the and to cover persons who begin, or are proposing to begin, manufacturing or basic decision whether testing for a particular biological effect should be processing a listed chemical during that period. carried out. For example, studies Persons who are nol involved with a submitted on chlorinated benzenes chemical when it is listed but contributed significantly to EPA's design manufactured or processed it or of a testing scheme for mutagenicity. proposed to do so any time during the The Agency, itself, will conduct these ten years prior to the time it is listed, are tests. Similarly, studies submitted on required to submit copies of studies for monochlorobenzene supported our that chemical, but are not required to list decisions on the need for testing of the studies. reproductive effects of that substance. Since the proposal, changes have been These are examples of two important made regarding the types of studies that contributions that submitted studies can must be submitted. Several types have make to testing decisions. Overview of Rule Requirements been exempted. The final requirements represent the Agency's effort to reduce the burden of the rule while still Extensive comment was received on obtaining the most useful studies for our the question of what records a company assessments. EPA received many good should search to comply with this rule. comments that allowed the Agency to CAPCO JEN 0012313 - J jnuiMuay, September 2, 1982 / Rules and Regulations --38781 identify the studies that were most whole or in part, for the purpose of or mixture that is being manufactured, burdensome to submit and least useful obtaining a commercial advantage for processed, used, or disposed of. Other for its assessments. Therefore, the the manufacturer or processor as substances that are produced as Agency has added to the exemptions distinguished from charitable or byproducts, but not separated from the- originally proposed. The final nde has academic purposes. Therefore, product, are impurities of the product the following overall exemption$:'(l) i: chemicals manufactured for product and are thus not covered in the present Physical and chemical properties othe:r research and development (R & D), as rule. . .. than ten that are specifically listed; (2)' well as byproducts and impurities of . This rule requires manufacturers of studies of a substance orlmixture that a- commercial manufacturing and ' these separated byproducts to report.. -' person has manufactured or processed/., processing, are "for commercial '' ' studies on them and on mixtures vr proposed to manufacture or process;/,, purposes." . ~ containing them. Thus, persons who ' as an impurity; (3) published studies; (4)' EPA received comments saying that manufacture a listed chemical as a non-confidential studied submitted the Agency's interpretation is wrong known byproduct that they separate previously to another Federal agency; v..- because these substances themselves * during manufacture, processing, use, or (5) all studies previously submitted to'./ are not actually marketed, and, in the. . . disposal of another chemical must SPA (this includes studies voluntarily ;' case of byproducts and impurities, are ' report studies on the known byproduct. ; submitted during section 4 proceedings not desired for the market. However," the ,.EPA equates these studies with studies . or wider the previous section 8(d) rule);~'_ Agency considers it undeniable that ; - of the same chemicals as desired . -. (5) studies of chemical substances which." products of commercial endeavors are' products. The studies will be just as - . ' are not bn the TSCA Chemical made for commercial purposes, . telling on the effects of the chemicals. Substance Inventory, i.e., research and' Moreover, the reason that section 8 of (3) R&D Chemicals, The Third Circuit development studies on new chemical ;'} TSCA exists is to give the Agency . has upheld EPA in its view that - substances, and (7) underlying data such,- access to information from which it can substances manufactured forR&D. -- os medical records, monitoring data, and assess the nature and significance of purposes are manufactured for lab notebooks (unless the EPA requests/ chemical hazards and risks. TSCA is : commercial purposes, Dow v. EPA. 605 the data later, by personal letter). Iir intended to address these/hazards and F. 2d 673 (3rd Cir. 3979J.EPA discussed . addition; certain types of studies of " risks to health or the environment- . . the importance of these studies in the - nixtures are exempted as stated below. whether or not the chemicals are desired preamble to the proposed rule and' In summary, the reportable studies commercial products. continue to regard them as important re; (1) Studies of listed chemicals with The commenters thought that the resources in investigating the effects and he seven exclusions noted above; and ' Inventory Rule exempted reporting of' risks associated with substances. !) studies of mixtures containing listed : byproducts, impurities, and R & D. - However, to minimize theburden of this remicals with the seven exclusions . chemicals because they were not - requirement, EPA has exe'mpted persons vted above and atso excluding: acute considered to be "for commercial from reporting studies on chemical al toxicity studies, acute dermal purposes." On the contrary, this section substances that are not on the TSCA xicity studies, acute inhalation 8(d) rule is completely consistent with Chemical Substances Inventory, e.g., deity studies, primary eye irritation the Inventory rule, both rules define new chemical substances. When a , idles, primary dermal irritation - - - these chemicals as "for commercial premanufacture notice (PMN) is ; ' dies, and physical and chemical purposes." The Inventory Rule submitted on a new substance, any perties. - ... exempted such substances only because health and safety data on the substance, ;an!zation of This Preamble PA received more than 300 looses to the proposed rule, each they were not appropriate for inclusion in the Inventory. In this final rule the Agency has limited the potential reach of this interpretation. A description of would be submitted. B. Propose to Manufacture, Process, or Distribute taining multiple comments. Several rets of the rule received numerous ments; other aspects, only one or a In this preamble, the Agency isses the major comment areas: ~ fie definitions; chemical substances ct to the rule; lists and copies to be itted and who should submit them:. is not subject to mandatory ing; file search; reporting schedule inset provision; confidentiality; '.onomic impact. The subjects that id only one or a few comments Uviduatly discussed in a snt entitled "General Comments Proposed Section 8(d) Rule" s part of the public record. the applicability of the rule to impurities, byproducts, and R & D chemicals follows..-, .. - (1) Impurities. Under this rule, EPA has excluded from reporting any studies of chemicals that the person reporting has manufactured or processed or has proposed to manufacture or process -only as impurities. . - /' Since the chemicals presently listed In' the rule'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 "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 could 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 fic Definitions - excluded studies to be reported for some manufacture, process, or distribute the ifaciure andProcessfor ' ' -ciol Purposes chemicals. listed substances because they would (2) Byproducts. It should be noted that r.ot have many studies. EPA has not the definition of "manufacture for adopted this suggestion. Valuable iterprets the term "manufacture commercial purposes" includes only studies might be missed if these persons ss far commercial purposes" to byproduct substances and mixtures that are exempted. The Agency would be uch activities conducted, in are separated from the other substance particularly interested in the results of a f CAPCO JEN 38783 Federal. Register / Vol. 47. No. 171 7 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 to 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. The Agency has not changed the definition. The Agency believes it is as specific as a definition of such a concept can be, given the variability of businesses covered. C. Health and Safety Study Many commenters argued that some of the examples of health and safety studies given in the proposed definition are not "studies" in their view. They argued that only studies designed to provide a direct measure of effects on human health or the environment should be included. They cited two kinds of studies they would exclude as not being direct measures. One kind was measurement of a chemical's concentration in the workplace or environment. Another kind was measurements of properties of chemicals, such as: biological, photochemical, and chemical degradation; air, water, and soil transport; and water solubility, vapor pressure, and octanol/water partition coefficient The Agency disagrees with this narrow view. The legislative history of TSCA indicates that Congress expects the Agency to collect : broad range of information relevant to health and environmental effects. It is intended that the term (health and safety studies] be interpreted broadly. Not only is information which arises as a result of a formal, disciplined study included, but other information relating to the effects of a chemical substance or mixture on health and the environment is also included. Any data which bears on the effects of a chemical substance on health or the environment would be included. H.R. Rep. No. 34-179, 94th Cong.. 2nd Sess. 58 (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 ofconcentration. 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; (e) density/relative density (specific gravity); (f) particle size distribution for insoluble solids; (g) dissociation constant; (h) degradation by photochemical mechanisms--aquatic and atmospheric; (i) degradation by chemical mechanisms--hydrolytic, reductive, and oxidative; and (j) degradation by biological mechanisms-- aerobic and anaerobic. These properties of a chemical are very important elements to consider in assessing its potential biological effects. For example, water solubility and partition coefficient bear on the question of whether a chemical could become deposited in body fat tissues. For another example, all of the properties are informative on the questions of whether a chemical released into the environment would remain for a long time and be transportedovera 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 informative, 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 ' is 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 less 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, adverse biological effects were discovered following extensive testing undertaken only after the discovery of widespread environmental contamination. (See Howard. P. H., et at. 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.) CAPCO JEN 0012315 Federal Register / Vol. 47,' No. 171 / Thursday, September 2, 1982 / Rules'and Regulations ' 38733 ' (3) Underlying data. Data such as Several chemicals In the proposed list the Agency must show for each individual monitoring records or ` have been removed in the final rule. A chemical subject to the rule that the employee medical records that may subset of one category of chemicals, information requested is not available underlie an epidemiological or exposure listed in the proposal as "organotins" from other sources. ' study are not required to be submitted (selected by EPA) was subsequently EPA believes it has justified, to the ns initial reports under the rule. EPA recommended for testing by the ITC, 45 extent required by section 8(d), the need may request these and other underlying FR 78432 (November 25.1S80). The ITC for reporting on the chemicals subject to data such as lab notebooks as a follow had recommended the subset the final rule. The Agency disagrees lip to its examination of a study. The ` "alkyltins." However, the ITC has with the comments on the level of detail Agency does not anticipate making such subsequently removed this category required to justify reporting. The requests very frequently. It will do so from the section 4(a) Priority list for comments would require that the when a question of interpretation arises -reconsideration (47 FR 5459). EPA has . Agency prepare an-extensive chemical . (such as when the Agency has studies " deferred reporting on these and the specific determination that would whose results appear to conflict] and an other organotins for a later proposal. require a search of the entire scientific examination of the underlying data may Another category of chemicals, acrylic literature and all available sources and clarify the problem. .... . acid and methylacrylic acid and their a complete hazard analysis of the D. Known to andPossession - ' esters, has been removed from the rule. chemical. Thus, according to the EPA will propose the category in a ' comments, section 8(d) could be used - As previously discussed, the Agency future iteration of this rule after it has ' only to obtain information as a last has decided to delete definitions of better defined the category. Dioxin and resort. This is contrary to the intent of "known to" and "possession" and, related substances have also been TSCA. There is nothing in the language Instead, describe the kind of file search removed from the rule. Since proposing that will suffice for compliance with this their inclusion in this rule, the Agency or legislative history of the Act to indicate that section 8(d) is to be used in rule. From comments received on the. has carried out administrative such a manner. On the contrary, section proposed definitions, it is apparent that proceedings dealing with dioxin issues ' the definitional approach to delineating which have covered the ground that - a responsibility to search for studies is would have been covered by having the too indirect The matter is discussed chemicals reported under this rule. further under the preamble section titled Other chemicals removed from the rule "File Search." include acrylonitrile, H. Chemical Substances Subject to the Rule;............... ........................... r" alphachlorotoluene, benzene, benzene (epoxyethyl), chlorendic anhydride, chlorodifluoromethane, 1,2- Section 718.17 of the rule contains a dichloroethane, 2-chloro-l,3-butadiene, list of chemical substances subject to ethyl benzene, iodomethane (methyl the rule. A subsection of 718.17 is iodide), morpholine, reserved for future listing of designated nitrosodiethanolamine, 2-nitropropane, mixtures subject to the rule. and vinylbenzene (s tyrene). These The majority of the chemicals chemicals were removed for a number presently listed are ones for which the of reasons. Some (e.g., benzene, styrene) ITC has recommended that EPA propose were the subject of earlier section 8(e) testing rules. It is important that EPA submissions and have since been review unpublished studies on these referred to other EPA program offices or chemicals to avoid unknowingly Federal agencies for study. The proposing testing under section 4 that / remainder were under early stages of may already have been done, and to assessment when they were added to base judgments about testing on as full the proposed rule. In the intervening an overview of existing information as time, however, the Agency has brought practicable. The goal is to focus some of these assessments to near proposals for testing as efficiently as completion, e.gi, 2-nitropropane. 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 (1976).) ; 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 InteragencyTesting 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 6(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. present knowledge will permit The list tn 718.17 contains two Several comments argued that EPA did not provide adequate public notice' As to the comment that EPA must indicate for each chemical that groups of chemicals. One group consists and opportunity for comment because information required by this rule cannot of the chemicals recommended by the the Agency did not state in its proposal be obtained from other sources, the final ITC for testing. The other group of `. a reasoned explanation of how or why rule in fact accommodates this comment' chemicals includes the asbestiform; ' '. each particular chemical was selected.' by excluding from rule requirements any varieties of chrysotile, crocidolite, These comments said that the Agency studies available from sources to which amosite, anthophyllite, tremolite, and must, for each chemical, show that the EPA has access--published studies and actinolite, i.e., asbestos, which is being information to be reported will studies submitted to other Federal considered for control. contribute to articulated regulatory agencies without confidentiality claims. The bisazobiphenyt (BAB) dyes were objectives. In particular, they stated that The studies subject to the rule are those recommended for testing, and are the EPA must show why it believes that not otherwise available to the Agency. subject of a broader Federal effort. each chemical might pose a risk to Several comments argue that to Assessment actions are underway at CPSC and OSHA. In addition, the BAB dyes are being tested by CPSC (skinabsorption) and at the National Center health or the environment and why published studies provide insufficient information for conducting a risk assessment, evaluating the need for 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 for Toxicological Research (metabolism testing, or considering other regulatory information requested is not more studies]. options. These comments also claimed detailed or extensive than necessary. CAPCO JEN 0012316 38784' `Federal Register / Vol. 47, No. 171 / Thursday. September 2, 1982 / Rules and Regulations and will not burden more persons than necessary with reporting obligations. EPA concurs that as a matter of sound policy these factors should be considered by the Agency for this section 8(d) 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 Us reasons for not initiating such a proceeding. Because it has such a short period of time to make thi3 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 die 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 8(d) studies in deciding whether to initiate proceedings to require testing and has discussed examples showing that unpublished studies submitted previously have been valuable in " section 4 proceedings. Receipt of significant studies at this late stage that could cause fundamental revision of the basic analyses would make it impossible to meet the Agency's oneyear deadline. The Agency has also considered inthis 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 ba 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 has found that, while studies may be voluntarily submitted in some cases, nil 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'8 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 8(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. IB. 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. Requirementsfor Submitting Copies ofStudies . . Two requirements to submit copies of studies will apply. First, any person who has manufactured or processed or who has proposed to manufacture or process . a substance or designated mixture listed in 5 718.17, within the ten years ' preceding and including the date the . 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 smd processors of the chemical when such persons are identified as possessing studies listed by someone else in accordance with 715.12. 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 past and present manufacturers, processors, and distributors of the chemicals selected by EPA since, in the commenters' view, these would obviously be the parties with the greatest interest in developing data, and thus the ones most likely to possess it. EPA agrees and has changed the initial reporting under the rule accordingly. However, EPA may later CAPCO JEN 0012317 Federal Register / Vol. 47, No. 171 / Thursday. September 2, 1982 / Rules* and Regulations 38785 request any person, who is listed need only consult its records not retired (6) Limit initial reporting to key pursuant to j 716.7 as possessing a . prior to December 31,1979, either for studies relevant to specified effects study, to submit that study. studies or for answering the question of {such as those the ITC recommends be ' (2) Limit the copy submission ' whether it dealt with a chemical in the tested) in order to produce studies most - requirement of past manufacturers to .. past. The more valuable, older studies valuable to risk assessment, and to those who have manufactured since will likely have been preserved in . reduce reporting burdens and EPA's . 1S85,1970,1975, or presently , current files, rather than being retired. In review burden. ' . manufacture instead of since 1S50 as addition, searching long-retired files This suggestion was not adopted. EPA .- proposed. The commenters maintain ,... could be very' costly; too costly for - plans to investigate a full range of- ' ` that these ``cut-off' dates would tend to purchas'e of this rule. December 31,1979 properties and effects of the listed : ' reduce the volume of studies collected ; .is the date on which potential . chemicals. Effects of a substance are not and would maximize the quality of the respondents to this rule were put bn discrete items, unrelated to one another. studies being collected since, in the ' notice of the Agency's intention to On the contrary, certain effects mid . commenters' view, older studies tend to require this reporting, and it is therefore . properties are predictive of other effects be of less value, v- an appropriate date to define the limits ' and properties. For instance, fate and . EPA retained the reporting of the file search,./; '/.. ' ...v persistence studies will help in ', ' requirements for past manufacturers and (3) Limit the rule to persons who . ' predicting environmental effects.'Acute processors because they'are just as reported the chemicals for the Inventory. toxicity studies generally provide data likely to have good studies as present, This would reduce the company's to determine the median lethal dose. manufacturers and processors. EPA burden in determining its responsibility (LD50) of a chemical substance (its proposes the January 1,1950 date under a section 8(d) rule merely to relative toxicity), but also may provide because persons who have dealt with . checking the list of chemicals it reported data to judge its mode(s) of action, to .. the chemical and performed studies in for the Inventory, and would yield the-. determine its specific toxic effect(s).on the last thirty years would have utilized . higher quality data developed by the ; v target organs and functions, and to. ... ' more advanced analytical techniques. ,' " manufacturer or processor. ' determine the existence and extent of The'Agency received comments "T EPA did not adopt this suggestion for * species differences in sensitivity to a' ' . basically agreeing with EPA's view that _! two reasons. Complete reporting for the chemical. Acute effects studies designed there is a time in the past beyond which Inventory was limited to manufacturers to measure potential ecological effects techniques were not so good as they are'' whereas section 8(d) also applies to now. However, commenters suggested - - processors. In addition, the implicit. cut-off dates'from 1965 to 1975. with assumption that only those who . most commenters suggesting 1970 as a reported for the Inventory would have a :ut-off date because they believe that list of their Inventory chemicals is not . nformation more than ten years old valid. All manufacturers and processors aay be outdated and of little value. of chemicals must know if the chemicals Commenters agree that more they make are on the Inventory, whether dvanced analytical techniques were they reported for the Inventory or not.. sed after 1950, but they maintain that They must know, because they must lost of the more sensitive detectors and submit a premariufacture notice to EPA :chniques for gas chromatography,' under section 5 of TSCA, before making ' !omic absorption spectroscopy, and or processing a chemical that is not on fra-red spectroscopy were developed ' the Inventory. iring the last decade. - (4) Decrease the burden of section 8(d) For instance, the late 1960`s saw the ' rulemaking and subsequent regulations ~st commerically available liquid ' - - by asking major manufacturers' - iromatography unit, while the first ga3 voluntarily to submit studies. If ' romatography unit with infra-red manufacturers refuse to do so, then the - ectrophotography was not available Agency could proceed .with section 8(d) .. til 1972. Also, many of the screening rulemaking, or go directly to section 4 ,, , sts'used today, such as the Ames Test, rulemaking.. " " ' :re developed during the last decade. ,, EPA did not adopt this's'uggestion; ' are especially valuable since there is comparatively less information in tins field than in others'Alsri. 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 a base set of recommended tests containing a range bf tests of physical and chemical properties and toxicity forassessing the hazards of chemicals. It has selected many physical and chemical properties that, in its view, constitute ``information for degradation, accumulation and even noxious effects .. assessment *,,*/_} For example, the shape of a particle can, in.itself,.be/ . a commenters were persuasive that Although some companies may submit-.' indicative of its carcinogenicnature? ... - rty years is inappropriate and that a certain studies voluntarily, it is (e.g.< asbestos fibers) and the partition . irter time span would be appropriate, important that EPA receive all relevant- coefficient i3 indicative of likely . srefore, the final rule states the studies. Only a section 8(d) rule can accumulation in lipid tissues." OECD iod as ten years prior to the effective ensure this. In addition, many Chemicals Testing Programme, Expert. e for reporting on a chemical. This commenters stated that many studies Group, Physical Chemistry, Final Report ! keep the ten-year period constant contain trade secret information which Vol. 1, p. 41. In addition to physical and the future. Holding to the 1950 date companies are very reluctant to submit chemical properties, the OECD has also dd result in an ever-lengthening span voluntarily. included many acute, subacute, and. his rule is used in the future. (5) First require lists or titles of chronic tests in the base set of tests. Cost of the concerns expressed about studies that have been performed by' " (7) Limit the chemicals subject to the long time span were concerns about manufacturers or processors of the- rule to "high priority" chemicals such as panies potentially having to search listed chemicals and then later request ITC chemicals to match exactly the ITC ed files either for studies or io find copies of selected studies. recommendations and reduce the - whether the company had dealt with This suggestion was not adopted reporting burden. - hemical in the past. To avoid this because insufficient information is EPA did not adopt this suggestion. ' lem of retired files, the Agency has contained in the titles of studies to give The chemicals recommended by the ITC ified in the rule that a company . a basis for study selection.. may be in fact the majority group on the I. CAPCO JEN 0012318  .38786 , Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations rule, but they are not the only chemicals requested, when an ongoing study is greatest number of comments. The on which EPA will need studies. The listed. They asserted that partial and commenters were almost evenly divided hazards oF other chemials are and will incomplete data can be extremely on whether the proposed exemption or a be under investigation. misleading. Also, they said a scientist modified version of it should appear in 27. Requirementsfor Submitting Lists of Studies should not be required to disclose the the final rule. Some comments stressed results of his research until the scientist the difficulty of predicting the effects of is satisfied with the accuracy, reliability, a single component of a mixture from The Ena] rule adopts the proposed and scientific significance of the data. results obtained from testing the entire requirement that only current. .. .: The Agency disagrees. It requires a mixture. Therefore, they suggested the manufacturers and processors of listed l . list of ongoing health and safety studies Agency should not require the chemicals and those who propose to . to tailor testing rules to fill real gaps in submission of any mixture studies. manufacture or process these chemicals ^ knowledge. If industry has started Other comments suggested'that the must submit lists of studies.^ ' 'i\' enough research of a particular type, the Agency fine-tune the exemption by Several comments objected to listing . Agency could exclude that type of requiring only submittal of a study on a records kept on employees exposed to testing from a testing rule or delay it chemicals. They assert that record .. 1 until the test data are available to the systems and data do not constitute a ' Agency. For chemicals for which testing study unless an intention to correlate , is not contemplated, the submission of certain data to evaluate results and lists of ongoing studies will help the reach conclusions is declared. A record Agency determine the scope of possible listing requirement would move the ' control regulations. If, for example, the scope of the requirements into the realm Agency is considering control of a of conjecture, and render the proposal, particular use of a substance, the in thi3 respect at least, impracticable, knowledge that a person is testing that 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 substance to determine its effects or potential for exposure to man or the environment would be valuable information. to which particular chemicals any given The Agency will not routinely require 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 preliminary reports to be submitted. However, under procedures stated in 718.8, EPA may ask for the submission of preliminary reports when necessary. The Agency understands the concern a scientist might have about releasing preliminary data. However, sometimes it is necessary to track the progress of a long-term animal study, for example, so that the Agency can order its assessment priorities. It is far more costeffective to monitor a study industry is `performing than to propose a testing rule or take regulatory action that might be found to be unnecessary when the final test results are reported. 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 5 718.11 (e) through (hj 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 be submitted, as the proposed rule would have required, since protocols are not health and safety studies and contribute no relevant health and safety IV. Studies Not Subject To Mandatory Reporting A. Exemptionsfor Studies ofMixtures review necessary to determine which mixture studies should be submitted, the reporting burden on persons will be significantly reduced. .* information regarding chemicals. EPA has adopted the limitations The proposed rule provided four exceptions to the reporting ' B. "Substance" Versus''Mixture" suggested. Copies of protocols do not requirements. Persons did not have to- .In the final rule ( 718.4), EPA clarifies have to be submitted since they will submit: (1) Copies or lists of published how certain preparations of substances usually be described in the study studies: (2) copies of.studies previously should be treated. For example, one eventually reported. submitted to Federal agencies with no commenter indicated that he considered Some comments objected to listing claims of confidentiality: (3) copies of an aqueous solution of a substance to be ongoing studies. They maintained that studies conducted by other persons a mixture. Since one often puts a section 8(d) applies only to completed subject to the rule: or (4) copies or lists substance into aqueous solution before studies. EPA disagrees with this of studies of mixtures containing small testing it for biological activity, the comment. Section 8(d) authorizes listing amounts of listed substances when the commenter's view could result in many of a study "conducted or initiated by or studies clearly did not reflect effects of tests being reported as tests of mixtures.- for" a company. EPA may require listing the listed substances. Comments This would be an absurd result in the once a study has begun because it has addressing items (1) through (3) above, context of this rule. Studies of the been "initiated" within the meaning of and EPA's responses, appear in following preparations of a chemical the statute. "General Comments on the Proposed substance must be reported as studies of A few comments questioned the need Section 8[d] Rule." the chemical substance itself, not as for listing ongoing studies and for The exemption for reporting mixture studies of mixtures containing the submitting preliminary reports, if studies (number 4 above) generated the substance: CAPCO JFM nni931Q 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 contract's 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 will 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 ' - ridded 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 y will be made when the study is ordered grade of purity. ___ ..................... -..W-.)' 'component of a mixture should be able' to be done. In addition.-EPA hasTimited f Studies .of these preparationsof.'?'.,,-:^ ' ;to examine the mixture studies they - this'continuing reporting requirement to./ substances are classified for reporting7 possess to see if any components`of the chronic studies; long-and short-term'; ?? zs studies of the substance. EPA does mixture studied are on the section 8(d): tests ofmutagenicity, cardnogemcityj or, not, and heed not, at this time reach the .chemical list: Since most of the studies.., teratogenicity; end the biological and ill/ issue of whether these preparations are , .normally performed on mixtures are ff environmental fate tests listed in'-v defined as mixtures or chemical 'exempted by the rule,' most companies' 716.10(h) through (j). . substances underTSCA..^v 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 commenters regarding the file search required by the proposed rule, the final rule contains a provision' describing the file search required. Persons can satisfy the requirements of this rule 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 subchronic and chronic studies'on.',;~y 'mixtures to determine which studies r should be submitted:r-W- r- -'wi? - VI, Reporting Schedule and Sunset Provision - Persons must submit lists and copies'* of studies no.later than sixty days after.^, the effective date of promulgation of the7 list of chemcial substances and mixtures . In -716.17. The rule also provides for />' extending the submission deadline for a7 reasonable period, if a company.. ` / requests such an extension because of: long file searches: w Because they assumed a very . extensive file search was required, 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 1TC .. - 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 data of the initiation of new studies could affect EPA's final action. Even - can be approached in a number of ways many commenters suggested that sixty - after a test rule is promulgated or a . - depending on the size of the company days was insufficient time to comply voluntary testing agreement is reached,. and the type of chemicals for which with the rule. EPA is retaining the new data on substances under test will studies will be submitted. EPA includes proposed schedule because it has made be important in the Agency's evaluation following discussion to convey how significant changes to reduce the search of the chemical subsequent to testing elieves a satisfactory search might ' burden. The scope of this final rule is and could contribute to a decision =onabIy be conducted with the least less than that of the previous section whether control action for the chemical v . anditure of resources. The Agency is 8(d) rule under which companies Vindicated. However, to balance EPA's not saying that this is how companies reported in 1979 since many exemptions - 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 . 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 submit 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 ' prior to the sunset date. Comments are indexed. Alternatively, they might considered this to be too burdensome VII. Confidentiality determine the chemicals they handle(d) since it would require them to search EPA is aware of the need to protect then search for studies. continuously for all new studies. EPA confidential business information. The Agency expects the search for agrees that the proposed provision was Several commenters suggested that the physical and chemical properties to be too broad. The Agency has changed the regulations should contain a specific, minimal for all companies because of requirement. Under the final rule, these statement about the means EPA would the very limited number of properties persons will be responsible only for use to protect the confidentiality of that are subject to the rule. Also, the informing EPA of studies initiated by or information in the unedited copy of a Agency expects that companies will for them, rather than of-any nevv study. study. have a special reference file for the most This 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 -33788--'Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations safeguarding confidential business information submitted under TSCA. (The manual is available from the OPTS industry Assistance Office--see FOR FURTHER INFORMATION CONTACT.) EPA will share confidential information with contractors, other EPA offices, and other Federal agencies only in accordance with these procedures. In addition, all information 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 study confidential. However, health and safety information about a chemical that has been offered for commercial distribution or is subject to testing under section 4 or notice under section 5 can be withheld from disclosure only to the extent that disclosure would reveal (1) processing information and (2) percent composition of mixtures, or contains information the disclosure of which would clearly be an unwarranted invasion of personal privacy (such as individual medical records), as provided in S U.S.C. 552(b)(6). Any claims 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 esumptively consider failure to submit :e 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 the proposed regulation that detail the methods for submitting confidential information. . ' - ' One assertion was that submitters should not be burdened with "up front" substantiation for claims of confidentiality, and that such . substantiation should be required only if EPA receives a Freedom of Information Act (FOIA) request for the information. The Agency will not require "up front" substantiation. The language of 716.16(c) has dropped the requirement that the basis of the claim be "explicitly" explained at the time of submission. The claim must still be explained briefly. However, this explanation should merely be a simple statement indicating that the reason for the claim is, for example, related to mixture proportion or process information, or that the information is clearly irrelevant to the health and safety study. EPA does not expect detailed substantiation of confidentiality claims at the time the study is submitted. The Agency believes that this simple statement is justified, because EPA needs some understanding of the claim to have a basis for initial denial or granting of FOIA requests and to protect the information. Another suggestion was that failure to provide a nonconfidential second copy of a study for which claims are made 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 made and FOIA principles require that it be granted. EPA will not place confidential information in the public file automatically if a second copy is not received. The Agency will notify the respondent that it has not received a second copy. This will allow the company to correct the situation. . Another commenter claimed that the 20-day grace period for correcting incomplete confidentiality submissions does not allow the respondent sufficient . time to respond. The rule has been changed to extend the proposed 20-day grace period to 30 days. This should be adequate for such a straightforward response, even given mail delays, because the only step needed is to provide a second, non- confidential copy for the public file. A final specific comment was that the Agency must not allow confidentiality claims for submitted health and safety studies. To do so, is, in the commenter'* ' view, a direct, illegal contradiction of section 14(b) which exempts the results of health and safety studies from such claims. EPA disagrees that it should not allow confidentiality claims. Respondents may claim any information as confidential; however, the only information which the Agency may actually keep confidential is listed in 716.16(c). VIII. Economic Impact EPA estimates that the total cost to industry of submitting lists and copies of health and safety studies under the present rule is approximately 3537,000. The major cost to a firm will be the cost of a file search to determine what health and safety studies it possesses. This cost will, of course, vary directly with the size of the firm, assuming that larger firms have more files at more locations which must be accessed. Once the studies are located, the remaining compliance costs involve copying and processing the studies, making lists of studies which are in progress or not in the possession of the respondent, and reviewing the studies for confidential information. The Agency's cost estimates are based on the cost to an average firm. EPA recognizes that actual costs will be larger or smaller for larger or smaller firms. Each of these costs is tabulated below. : - Total Trrtal mt1 nt t*it ml* 537,000 This represents a cost of approximately S2.0C0 to $4,000 per ` chemical. When the Agency adds to the list of chemicals subject to the nite. these cost per chemical esircrales caaba 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 Sl.300,000 to perform the proposed testing (see 45 FR 43557) for chloromethane and'up to 34.SOO.CCO for chlorobenzenes (see 45 FR 43557). The Agency received many comments suggesting that its original estimate of $410,000 total cost was too Soar. The . comments pointed to many features of the proposed Tale that they fceiieved would cause much greater burdens than the Agency had assumed. However, only a few comments actually gave EPA estimates of the time or money they would expend in complying with the proposal. For example, the Chemical Manufacturers Association suggested from a survey of thirteen of its members that the cost per company would be $400 to $10,000 per chemical, but this range estimate was not accompanied by data to indicate how the figures were generated. The following is a list of the most burdensome features of the proposal as cited by comments. For each feature, a description follows for the changes made in the final rule to reduce the burden. (1) One large burden commenters perceived was in searching Tor routine monitoring records and for medical ! 1 \ 3 nAPrtrj .ipn rri *7^0-1 Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 f Rules and Regulations 38789'- ................. . * > ............-- < I I M Uiiiwmp^-- ............................................................ ... ihiiihhi^^x-- 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. . (2) The proposed requirement to chemicals be exempted. They requested of the studies performed on the listed 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 searching1 & D Chemicals) because, as previously .- concentrated in the chemical, allied through records to determine whether a discussed in this preamble, the Agency... products, end petroleum refining . listed substance could be present in a does not believe that the fact that a ,., industries." " -?r.y 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 ' V .. 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 . (6} The report's impact analysis for proposal did not consider the ongoing excluded all physical/chemical - -- the proposal did not include the burden cost of reviewing newly completed - properties of mixtures; and the Agency ' to a company to familiarize itself with studies during the multiyear follow-up .' has 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 must be conducted analysis. Since firms wotM iirazie.w substance--EPA will make that. .,.. by firms which will not actually find newly completed studies for'their'effects judgment. These changes should cut the submittable studies in their file. regardless of this rule, no file retrieval ' cost of submitting mixture studies Commenters suggested EPA account for ' 'costs associated with other health and substantially. The changes mean that these costs. safety studies would be incurred for companies can go directly to their In the first analysis, EPA attempted to copies of studies on mixtures to see if a base cost estimates upon the prior listed chemical was in a mixture tested.. experience of firms which reported for . The number of studies to be looked at the original section 8(d) rule. These data has been much reduced. And, most did not reflect the experience of firms importantly, companies will not have to which conducted futile file searches, search records to find out what and did not report. The Agency believes impurities may bave.been present in the that for the purposes of a report impact studied mixture. analysis, the previous experience of the (3) The proposal would have required prior section 8(d) rule is the firmest companies who may never have dealt . estimate that the Agency can utilize. with a chemical to submit studies on it if However, EPA has now attempted to they had then, EPA has removed this estimate costs for those companies that burden by changing the requirements to ' ' handle the listed substances, but have '. apply to those who have manufactured ' no studies .to report The Agency did this or processed or have proposed to by searching the TSCA Inventory to manufacture or process the chemical.- . determine the number of companies that Moreover, the Agency has said that reported the listed substances and then companies can determine their . . _ - * multiplying this number by a factor of association with the chemical by looking three to account for processors and . at their current files. This will alleviate a distributors. concern expressed by companies whose Although some commenters indicated these new ones. ' (9) Comments criticized continued reliance on the assumption that 2.3 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 the first section 8(d) rule. . .EPA's continued reliance on data from the first section 8(d) rule is valid. There- is no real qualitatively difference in the. chemicals subject to the original or . present section 8(d) rules--many of the chemicals subject to both ruleB are high volume and extremely prevalent. . Further, approximately 6.2 firms : - v reported for the Inventory an chemicals that were listed on the first section 8(d) rule (this figure represents .the average ownership or activities have changed and whose records have been retired. that the scope of the rule extends beyond the "chemical industry" and number of firms or companies, not the . average number of sites), whereas only (4) Perhaps the greatest burden cited woudl therefore increase the potential 2.6 firms responded per chenncalfarthe was that of potentially searching every number of processors of the listed original section 8(d) rule. For the company file for studies or references to substances beyond our estimate, EPA subsequent ITC-recommended studies. The proposal was broadly believes that its estimates or ' 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 of2.2 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. This indicated that the comply if they search the files where the chemical, allied products, and Agency's reliance on the 2.6 figure- - studies are kept in the ordinary course petroleum refining industries. Second, would actually tend to overstate the CAPCO JEN 0012322 38790 Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations number of expected respondents for the would not be enough to accommodate present rule. decisions on confidentiality. The (10) Comments were also concerned Agency's estimate of an average of one "about the categories of chemicals in the hour review per study is reasonable. rule. They specifically asked for better EPA does not expect that a company definitions of the categories or for lists should have to scrutinize e study for of the chemical in the categories for confidential information just before it is which EPA wants studies. Because of submitted to EPA. Confidential chemical nomenclature complexities, the information in a study should already commenters suggested that the burden have been identified as such by the of deciding whether a given chemical company. For example, to get a court to should be counted in or out could be 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, i.e., 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 cited burden. A company that whether each data element is has a question about whether a confidential. particular chemical is included in a category should call the information IX. Public Record number given at the beginning of this notice. EPA staff will be available to return these calls and answer questions. The basic elements EPA has included In the final Reports Impact Analysis are: (a) Corporate rule review--2 hours at $50 per hour. (b) Corporate identification of pertinent files--3 hours at $50 per hour. (c) File search at plant site--5 hours at $30 per hour. (d) Listing study titles--1 hour at $15 per hour. (e) Photocopying per study--X hour at S15 per hour. (f) Final review before submission--1 . hour at $50 per hour. EPA's estimate of total cost of the rule uses the above figures and assumes that 891 firms will perform an initial review; EPA has established a public record (docket number OPTS-84C03A) for this rulemaking document, which along with a complete index is available for inspection in the OPTS Reading Room,. Rm. E-107,401 M Street, SW, Washington, DC, 20460, from 8:00 a.m. to 4:00 p.m. 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 which constitute the record for this rulemaking. Public comments on the proposed rule are not individually listed, but will be available upon request in the OPTS reading room. EPA requests that it be notified of any additions or deletions to this record within the next 30 days. 447 firms will submit 3,784 reports of 50 (1) Health and Safety Study Reporting pages each; and each firm has, on a Regulations, July 18,1978. Public Record, weighted average, 1.5 plant sites. Docket No. 084CO1. - The corporate rule review step was (2) Manufacturing Chemists Association-- 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. Petition under section 21 of TSCA. September 12.1978. (3) Dental of Citizens' Petition, 43 FS 5872456727. (4) The entire docket in Dow Chemical Company v. United Stales Environmental Protection Agency, el ai. Docket No. 78-2203 (3rd Cir.J. These new estimates are based upon (5) Revocation of Rule, 44 FR 6099. suggestions from commenters and the (6) Reports Impact Analysis of this 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 for final review before submission rulemaking. (7) Alt 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 studies. (10) Records of ail communications between EPA personnel and persons 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.) (11) Minutes, summaries, or transcripts of any public meetings held to develop this rule. (12) Any factual information considered by the Agency in developing the rule. X. Regulatory Assessment Requirements Executive Order 12291 Under Executive Order 12291, EPA must judge whether 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 S1C0 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 review as required by Executive Order 12291. Regulatory Flexibility Act Since this rule was proposed before the effective date of the Regulatory Flexibility Act, 5 U.S.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 the respondents will have gross sales of less than 20 million dollars. Paperwork Reduction Act Information collection requirements contained in this regulation (5 716.6 and 716.7) have been approved by the Office of Management and Budget (OMB) under the provisions of the Paperwork Reduction Act of 1980 U.S.C. 3501 et seq. and have been assigned OMB Control Number 2070-C004. This rule requires manufacturers and processors of 40 chemicals and categories of chemicals to submit unpublished health and safety studies relating to these chemicals. The studies to be submitted will be used by EPA 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 716 Chemicals, Health and safety. Environmental protection, Hazardous materia! i, Recordkeeping and reporting. CAPCO JEN 0012323 Federal Register / Vol. 47, No. 171 / -Thursday, September 2, 1982 / Rules and-Regulations 38791' Dated: Augu3t 19,1982. John E. Daniel, Acting Administrator. 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: PART 716--HEALTH AND SAFETY DATA REPORTING. Subpart A--General Provisions Sec. - - 716.1 Scope and compliance.. 716.3 DeFinitions. 716.4 Overview of subpart requirements. ~ 716.6 Submission of copies of studies. 716.7 Submission of lists of studies. 716.3 EPA requests for submission of further information. ' , 716.9 How to report on substances and 1 mixtures. ' 716.10 Reporting physical and chemical properties. . 718.11 Exemptions to reporting . requirements. \ . ., . ; " 716.12 File search. 716.14 Reporting schedule. 718.18 Confidentiality claims. 718.17 Substances and designated mixtures to which this subpart applies. - 716.16 Additions to lists of substances and designated mixtures to which this subpart applies. ' . ' 718.19 Sunset provision. Authority: Sec. 8(d), Pub. L. 94-469, StaL 2029 (15 U.S.C. 2607(c)). ... Subpart A--General Provisions 716.1 Scope and compliance. (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. ,, - (b) Section 15(3) of TSCA makes it unlawful for any person to fail or refuse to'submit information required under this Subpart. Section 16 provides that a violation of section 15 renders a person liable to the United States for a civil penalty and possible criminal prosecution. Under section 17, the district courts of the United States have jurisdiction to restrain any violation of section 15. 716.3 Definitions. The definitions in section 3 of TSCA apply to this Subpart. In addition, the following definitions are provided for the purposes of this Subpart (a) "Byproduct" means a chemical relationships; air, water, and soil substance produced without a separate transport; biomagnification and commercial intent during the bioconcentration; and chemical and i manufacture, processing, use, or physical properties, e.g., boiling poinb disposal of another chemical vapor pressure, evaporation rates from substance(s) or mixture(s). soil and water, octanol/water partition (b) "Co-product" means a chemical coefficient, and water solubility. - substance produced for a commercial .. (iv).Monitoring data, when they have purpose during the manufacture, been aggregated and analyzed to - processing, use, or disposal of another measure the exposure of humans or the chemical substance(s) or mixture(s). environment to a chemical substance or - (c) "Copy of study" means the written mixture. . presentation of the purpose and (f) "Importer" means any person who , methodology of a study and its results. . imports a chemical substance, including (d) "EPA" means the United States a chemical substance as a part of a ' Environmental Protection Agency.' . .. mixture or article, into the customs - ' ' (e) "Health and safety study" or ' territory of the United States and "study" means any study of any effect.... includes the person primarily liable for of a chemical substance or mixture on the payment of any duties on the health or the environment or on both, ''' merchandise or an authorized agent' including underlying data and acting on his behalf (as defined in 19 - ' epidemiological studies, studies of CFR 1.11). Importer also includes, as ' occupational exposure to a chemical substance or mixture, toxicological, " appropriate: -. (1) The consignee. . clinical, and ecological or other studies '' ' (2) The importer of record. .'! of a chemical substance or mixture, and ' (3) The actual owner, if an actual any test performed under TSCA. (1) It is intended that the term "health - owner's declaration and superseding bond has been filed in accordance with and safety study" be interpreted broadly. Not only is information which arises as a result of a formal, disciplined study included, but other information- relating to the effects of a chemical substance or mixture on health or the ' environment is also included. Any data 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 that bear on the effects of a chemical customs territory of the United States substance on health or the environment.. would be included. Chemical identity ist consists of the 50 States, Puerto Rico, and the District of Columbia.. ' part of, or underlying data, to, a health ' (g) "Impurity" means a chemical and safety study. (2) Examples are: substance which is unintentionally present with another chemical (i) Long- and short-term tests of substance. mutagenicity, carcinogenicity, or (h) "Manufacture" and "Process" teratogenicity; data on behavioral mean manufacture or process for "... disorders; dermatoxicity; ' ... commercial purposes. " pharmacological effects; mammalian (i) "Manufacture for commercial absorption, distribution, metabolism. - purposes'' means: and excretion; cumulative, additive, and ' (1) To import, produce, or manufacture synergistic effects; and acute, with the purpose of obtaining an . .... subchronic, and chronic effects. . immediate or eventual commercial -" (ii) Tests for ecological or other advantage for the manufacturer, and ; environmental effects on invertebrates, . includes, among other things, such fish, or other animals, and plants, "manufacture" of any amount of a - including; acute toxicity tests, chronic chemical substance or mixture: toxicity tests, critical life stage tests, (1) For commercial distribution, behavioral tests, algal growth tests, seed - including for test marketing. . . germination tests, plant growth or (ii) For use by the manufacturer, /^. damage tests, microbial function tests, including use for product research and bioconcentration or bioaccumulation development, or as an intermediate. tests, and'model ecosystem (microcosm) (2) The term applies to substances studies. (iii) Assessments of human and that are produced coincidentally during the manufacture, processing, use, or environmental exposure, including disposal of another substance or workplace exposure, and impacts of a mixture, including both byproducts and particular chemical substance or coproducts that are separated from that mixture on the environment, including other substance or mixture and surveys, tests and studies of; Biological, impurities that remain in that substance photochemical, and chemical or mixture. Byproducts and impurities degradation; structure/activity. may not in themselves have commercial &bJ_ r C A P O .f^KI Afl 1 A O O'! 3*8792 Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations value.They are nonetheless produced for the purpose of obtaining a commercial advantage since they are part of the manufacture of a chemical product for a commercial purpose. (j) "Person" includes any individual, firm, company, corporation, jointventure, partnership, sole proprietorship, association, or any other business entity, any State or political subdivision thereof, any municipality, any interstate body, and any'department, agency, or Instrumentality of the Federal government. (k) "Process for commercial purposes" means the preparation of a chemicalsubstance or mixture, after its manufacture, for distribution in commerce with the purpose of obtaining an immediate or eventual commercial advantage for the processor. Processing of any amount of a chemical substance or mixture is included. If a chemical substance or mixture containing impurities is processed for commercial purposes, then those impurities are also processed for commercial purposes. (l) "Propose to manufacture, process, or distribute" 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. 2502(2)(A). (nj `TSCA" means the Toxic Substances Control Act 15 U.S.C. 2601 seq. s 716.4 Overview of subpart requirements. This section highlights basic requirements. For additional procedures, and qualifications, refer to pertinent, individual sections. {a) Adequate file search'for compliance with this subpart Persons are not required to search any records retired prior to December 31,1979 for information to comply with this subpart. In addition, the scope of a company's responsibility to search records is limited to records in which it ordinarily keeps the required information and to records kept by individual employees whose assigned duty is to advise the company of the health and environmental effects of chemicals under 716.12. (b) Persons who must report. (1) A person who manufactures or processes a substance or designated mixture listed in 716.17 at the lime it is listed, or proposes to do so, must do the following for that substance or designated mixture--(ij Submit copies of all nonexempted studies in his possession at the time he becomes subject to the rule under 716.6. Under 716.14 the copies must be submitted within 60 days after the addition of the substance or designated mixture to 716.17. (ii) Under 716.7 submit a list of studies that are ongoing when the substance or designated mixture is added to 716.17. The list must be submitted within 60 days after the addition of the substance or designated mixture to 716.17 and copies of such studies must be submitted within 30 days of their completion under 716.14. (iiij Inform EPA within 30 days of any study initiated by or for him after the initial 60 day reporting period and submit a copy of the study when it is : completed. This requirement continues until the sunset date specified in 716.19; it applies not only to persons who manufacture or process a substance or designated mixture when it is added to the list, but also to persons who begin to manufacture or process, or propose to do so at any time prior to the sunset .. date. (2) A person who is not covered under paragraph (b)(1) of this section, but has manufactured or processed a substance or designated mixture listed in 716.17, or has proposed to do so, anytime in the preceding ten years, must submit copies of studies in his possession on the substance or designated mixture within 60 days of when it is added to 716.17. (c) Studies to be reported. In general, studies, as defined at 716.3(d), that are unpublished are reportable, i.e., must be submitted or listed, for any substance or designated mixture listed in 716.17. However, this requirement ha3 limitations according to the nature of the material studied, so that--(1) All studies of substances and designated mixtures are reportable. However, in the case of * physical and chemical properties, only.: those studies listed in 716.10 must be; submitted. (2) Studies of mixtures known to contain substances or designated mixtures listed in 718.17 are reportable except for studies of physical and chemical properties and the studies exempted at 716.11(f) (1) through (6). (3) Studies of substances or designated mixtures that a person who is reporting has manufactured or processed or proposed to manufacture or process only as impurities are not generally reportable under 718.11(1). (4) Research and development studies on chemical substances not on the TSCA Chemical Substance Inventory are not reportable under 716.11(e). (5) Underlying data, such as medical or health records, individual files, lab notebooks, and da-ly monitoring records are not reportable except by special request under 5 716.8. 713.6 Submission of copies of studies. (a) (1) Except as provided in 5 716.10 and 716.11, persons must send to EPA copies of any health and safety studies in their possession for the substances or designated mixtures listed in 716.17. Persons are responsible for submitting copies on only the substances or designated mixtures which they have manufactured or processed or proposed to manufacture or process (including as known byproducts) within the ten years preceding the effective date for reporting on the substances or designated mixtures. Persons who list studies as ongoing under 716.7(a)(1) must submit them when they are completed." (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 later under 716.6. (b) Submissions under paragraph (a) of this section must 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 subnutting 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. and the accompanying cover letter must be submitted, preferably by certified mail, to: U.S. Environmental Protection- Agency, TSCA-8D1, P.O.Box 2060, >' Rockville, Maryland 20352. 716.7 Submission of lists o1 studies. (aj Except as provided in 716.10 and 718.11, persons must send the lists described in paragraphs (a) (1) and (2) of this section to EPA for each of the substances or designated mixtures listed in 718.17 which they manufacture or process or propose to manufacture or process (including as known byproducts). (1) A list of ongoing health and safety studies being conducted for or initiated by them, noting for each entry the purpose of the study, type of data collected, and progress and anticipated date of completion. This requirement continues until the sunset date specified by 716.19. Studies initiated after the initial 60 day reporting period must be listed if they included one or more of the following tesis: chronic tests; long- and short-term tests or mutagenicity, carcinogenicity or teratogenicity; and $ IM II w iii L.. i L s% w. 11 r i r A D/^A I i 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. tasis listed in 5 716.10 (h) through G)- preparations of a substance 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 to contain the substance. (1) The substance in aqueous solution. (2) The substance containing a small (5) Primary dermal irritation studies. * (6) Dermal sensitization studies. (7) Physical and chemical properties. accompany each entry on the list. 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 . accordancewith 716.12.. . (b) Submissions under paragraph (a) 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.V.'. -.. . .]; If the substance or designated mixture is an impurity, no reporting is required (see 716.il(i), below). , (g) Analyzed aggregations of . monitoring data based on monitoring data acquired more than five years - :- - preceding the date the substance or? ' - of this section must be indexed by 5 716.10 Reporting physical and chemical designated mixture was added to the list chemical, including CAS number if '" . properties.-.;;; .in 718.17. 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.' (c) The list of health and safety::~-',t~vp Studies of physical and chemical. properties must be reported under this subpart if performed for the purpose of determining the environmental or biological fate of a substance, and only if they investigated one or more of the following properties: -. ; \. . (a) water solubility.- '. ` (h) Analyzed aggregations of monitoring data on mixtures known to contain one or more substance or -designated mixtures listed in 716.17, when the monitoring data are not . ; analyzed to determine the exposure or concentration levels of the substances-' .or designated mixture listed in 716.17. studies should be-submitted, preferably1-^ (b) Adsorption/desorption on . --. (i) Studies on a substance or - .: , by. certified mail, to: U.S. Environmental;^ v particulate surfaces, e.g., soil. .. .. .. designated mixture listed in 716.17 . ProtectionAgency, TSCA-8D1; P.O. Box] ^ -'(c) Vapor pressure.; ' ' / that the person who is reporting has-' 2C60, Rockville, Maryland 20852-'' .....;' (d) Octanol/water partition ' manufactured or processed or proposed 5 716.8 EPA requests tor submission ot Jurther information... ................... . EPA may request the following.: submissions after the initial reporting under 5 716.6 and 718.7. If the requested submissions are not made, EPA may subpoena them under section 11 of TSCA, 15 U.S.C. 2610. `{a) Submissionof underlying data of the kind described in 716.6(a)(2) by persons who submit copies of studies under 716.6 or list studies under 716.7{a)(l). coefficient.: - - ' (e) Density/relative density (specific . - gravity): ' ' - .- . (f) Particle size distribution for"".' - insoluble solids. ' : (g) Dissociation constant' (h) Degradation by photochemical mechanisms--aquatic and atmospheric. (i) Degradation by chemical - mechanisms--hydrolytic, reductive, and oxidative. G) Degradation by biological mechanisms--aerobic and anaerobic. to manufacture or process only as an . impurity. When reporting of such studies is to be required, that reporting will be . separately proposed in the Federal Register. . 716.12 File search. ' " "V 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 (b) Submission of preliminary reports 5716.11 Exemptions to reporting advise the company on the health or of ongoing studies by persons who list requirements. environmental effects of chemicals. For the studies under 716.7(a)(1). The following are exempt from the purposes of this rule, persons do not ` (c) Submission of copies of studies by copy and list submission requirements have to search files retired prior to persons listed under 718.7(a)(2) as of 716.8 and 716.7. " ' - ' ' December 31,1979. " possessing them. . - (a) Studies which have been published in the scientific literature. --. .... 716.14 Reporting schedule. 5716.9 How to report on substances and ' mixtures. ' - .-.. (b) Studies previously submitted to .' (a) Except as provided in paragraphs EPA, e.g., studies voluntarily submitted " (b) and (c) of this section, submissions*' Section 716.17 contains two lists, one during section 4 proceedings or under -i -. -under 716.6 and 716.7 must be.; "--/ of substances and one of designated the previous section 8(d) rule. postmarked on or before 60 days after mixtures. Studies of listed substances (c) Studies previously submitted to'' - " the effective date of the listing of a J ' and designated mixtures shall be any Federal agency with no claims of substance ordesignated mixture in? reported as follows: confidentiality. 716.17 or within 60 days of proposing . .(a) When a substance is individually.? (d) Studies conducted or initiated by to manufacture or process a substance listed under 716.17(a), studies of the or for another person who is subject to or designated mixture if first done after substance and studies of mixtures 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 716.7 must inform EPA listed as a designated mixture under development studies on new chemical of any study initiated by or for them 716.17(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' jf mixture known to contain a substance listed as ongoing under 716.7(a)(1), or the designated mixture. or designated mixture listed in 716.17. studies initiated within the reporting flADPfl lew n a o o o c .38704..- Federal Register / Vo]. 47, No. 171 / Thursday, September 2, 1S82 / Rules and Regulations * period, must be submitted within 30 day9 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, 401 M Street, SW, Washington, D.C. 20460, Attn: Section 8(d) extension. 716.16 Confidentiality claims. (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 EPA 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: (i) processes used in the manufacturing or processing of a substance or mixture, or (ii) the portion of a mixture comprised by any of the substances in the mixture. (2) Any respondent who wishes to assert a claim that part of a study should be withheld from disclosure because disclosure would reveal a confidential process or quantitative mixture composition or other confidential information, should briefly state the basis of the claim, i.e., by saying "reveals confidential process information" or "reveals confidential mixture proportion data," and clearly 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 company, which is irrelevant to any health or environmental effect of a chemical, may be claimed confidential and r.ot subject to the disclosure requirements of section 14(b) of TSCA. Other information contained in a study, the disclosure of which would clearly be an unwarranted Invasion of personal privacy (such as individual medical records), will be considered confidential as provided in Title 5, United States Code, section 552(b)(6). (d) To assert a claim of confidentiality for data contained in a submitted document, the respondent must submit two copies of the document. (1) One copy must be complete. In that copy, the respondent must indicate what data, if any, are claimed as confidential by marking the specific information on each page with a label such as "confidential," "proprietary," or "trade secret" and briefly state the basis of the claim. (2) If some data are claimed as confidential, the respondent must submit a second copy. The second copy must be complete, except that all information claimed as confidential in the first copy must be deleted. (3) The first copy will be for internal use by EPA. The second copy will be placed in an open file to be available to the public. (4) Failure to furnish a second copy when information 13 claimed as confidential in the first copy will be considered a presumptive waiver of the claim of confidentiality. EPA will notify the respondent by certified mail that a ' finding of a presumptive waiver of the claim of confidentiality has been made. The respondent will be given 30 days from the date of receipt of notification to submit the required second copy. If the respondent fails to submit the second copy within the 30 days EPA will place the first copy in the public file. 716.17 Substances and designated mixtures to which this sutpart applies. (a)(1) Substances. The following substances are subject to this subpart as of October 4,1982. BTRI 01 Kt/ii, T<, r- Substances Acetonitrile, . Acrylamide. Alkyl epoxides -- including all noncyclic aliphatic hydrocarbons with one or- more epoxy functional groups,. R3 R* R2 = a or alkyl R3 = H or alkyl R4 = H or alkyl Groups "R1-R4 may contain one or more epoxide functions BILLING COD' 656D-50-H CAS Numbers (examples for groups) 75-05-8 79-06-1 75-21-8 75-56-9 106-88-7 1464-53-5 I CAPCO JEN 0012327 Federal Register / Voi. 47, No. 171 / Thursday, September 2,1982 / Rules and Regulations Substances Alkyl phthalates -- all alkyl esters of 1,2-benzene dicarboxylic acid (orthophthalic acid). o cx 4 -o--R -O--ft. Rj_- = alkyl-' 1*2 " alkyl Aniline -and chloro-, bromo-, and/or' nitro-aniiin'es. Antimony. Antimony trioxide.' Antimony sulfide. Aryl phosphates - phosphate esters of phenol or of alkyl-substituted phenols. Try-aryl and mixed alkyl and aryl esters are included but trialkyl esters are excluded. /OR, o=pf-oft X03 . CAS Numbers (examples or groups) 84-61-7 84-66-2 84-74-2 117-81-7 117-84-0 119-06-2 ' ` . 119-07-3 - .* 131-11-3 ...... 26761^40-0 27554-26-3 . 62-53-3 108-4 2r-9 88-74-4 121-87-9.:' 89-63-4 . 141-85-5 95-51-2 .147-82-0 95-76-1'. ' 554-00r7 - 95-82-9- 608-27-5 - 97-02-9 . 626-43-7- 99-09-2 634-93-5 99-29-6 '635-22-3 ' 99-30-9 827-94-1 100-01-6 1817-73-8 106-40-1 5388-62-5 106-47-8 6283-25-6 3531- 19-9 . 7440--36-0 1309-64-4' o it* .1 1345- 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 38793. 38798' ' Federal Register / Vol. 47, No. 171 / Thursday, September 2,1982 / Rules and Regulations Substances - phenyl, either unsubstituted or substituted with one or more alkyl or aralkyl gr<5ups r2 =_ alkyl; or 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 . Asbestos - Asbestiform varieties of; chrysotile (serpentine); crocidolite (riebeckite); amosite (cummingtonite- grunerite); anthophyllite; tremolite; and actinolite. '. Bisazobiphenyl dyes derived from benzidine and its congeners, orthotolidine (dimethy1benzidine) and dianisidine (dimethoxybenzidine). Chlorinated benzenes, mono-, and di-. Chlorinated benzenes, tri-,' tetra- and penta- CAS Numbers (examples for groups) 1332-21-4 12001 29-5 12172 73-5 17068 78-9 72-57-1 2602-46-2 91-92-9 2610-05-1 91-96-3 2893-80-3' 573-58-0 3530-19-6 992-59-6 3567-65-5 1937-37-7 3.626-28-6 2150-54-1 4335-09-5 ' 2429-71-2 6358-29-8 . 2429-73-4 6360-54-9 2429-74-5 6449-35-0 2429-79-0 663.7-88-3 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 2585-58-5 16143-79-6 20232- 70-6 95-50-1 106-46-7 108-90-7 541-73-1 37-61-6 95-94-3 108-70-3 120-82-1 608-93-5 634-66-2 634-90-2 i1 I i CAPCO JEN 0012329 Federal Register / Vol. 47, No. 171 / Thursday, September 2,1982 / Rules and Regulations ' 38797 Substances Chlorinated naphthalenes -- chlorinated derivatives of naphthalene (empirical formula c10Hxcly -where x+y=8). Chlorinated paraffins -- chlorinated-paraffin oils ,and chlorinated paraffin waxes/ with chlorine content of 35 percent through 70 percent by- weight. P Chloromethane (methyl chloride). . ' Cresols -- ortho, meta-, and . para-cresol. " - Cyclohexanone Diehloromethane. (metnylene chloride) 1,2-Dichloropropane. Giveidol and its derivatives-. , iH20-R R = H; alkyl, alkenyl or alkynyl; aryl; acyl - Where R = alkyl, alkenyl,' alkynyl, aryl, or acyl; any substituents . or functional groups may be present with the alkyl, etc., groups. CAS Numbers (examples for groups) 90-13-1 1321-64-8 1321-65-9 61788-76-9 - " 6344.9-39-8 . 68920-70-7 % . "" ! .Z .* ` 74-87.-3 .. 95-487-7 "106-44-5 108-39-4 108-94-r-l 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 -; > ;.= /- ' CAPCO JEN 00is>f?r?0 3-5798 ,, ' Federal Register / Vol. 47. No. 171 / Thursday, September 2,1982 / Rules and Regulations Substances * Haloyenated alkyl epoxides -- haloyenated 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. Ri R. R A. Ri R2 = R3= R4 " X or CnH2n+x_yXy <y*l to 2n+l) H or X or CnH2n+i_yXy (y0 to 2n+l) M or X or CnH2n+1_yXy <y0 to 2n+l) H or X or CnH2n+1_yXy {y=0 to 2n+l) X =* halogen , Groups Rx - r4 may contain one or'more epoxide functions. Hexachloro-1,3-butadiene. Hexachlorocyclopentadiene.' Hydroquinone. Isophorone. Mesityl oxide. .4,4'-Methylenedianiline. Methyl ethyl ketone. Methyl isobutyl ketone. Nitrobenzene. p-Phenylenediamine. Polychlorinated terphenyls -- polychlorinated ortho-, meta-, and para-terphenyls. Pyridine. Quinone. Toluene. 1,1,1-Trichloroethane (methyl chloroform). Vinyl fluoride. Vinylidene fluoride. Xylenes -- ortho-, meta-, and para-xylene. j {2) [Reserved] <b) [Reserved] B1LUMG CODE 6i^fO-C 87-68-3 77-47-4 123-31-9 78-59-1 141-79-7 101-77-9 78-93-3 103-10-1 98-95-3 106-50-3 11126-42-4 12642-23-8 61788-33-8 .110-86-1 106-51-4 108-83-3 71-55-6 75-02-5 75-38-7 95-47-6 106-42-3 108-38-3 I CAPCO JEN 0012331 Federal Register / Vol. 47, No, 171 / Thursday, September 2, 1982 / Rules and Regulations' 38799 716.18 Additions to lists ot substance* 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 substances and mixtures. - (a) Except as provided in paragraph fo] 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. 716.19 Sunset provision. The reporting period on a substance or designated mixture will terminate no later than three years after thatsubstance or designated mixture Is added to the list in 716.17. 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 716.17 (a) and (b). An earlier termination date may be published.for a substance or designated mixture at the discretion of . the Assistant Administrator for , Pesticides and Toxic Substances. ' , * v_ ,. . "T ; * [FRDot J3-240SJKled0-1-S2;SUam], BKX1HQ CODE 65SO-SO-M. "'!/ ' | I B CAPCO JEN OOI2332