38780 Federal Register 

## / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations.

ENVIRONMENTAL PROTECTION
AGENCY

40 CFR Part 716
[OPTS-84003A; TSH-FRL 2112-2]

Health and Safety Data Reporting; Submission of Listsand Copies of Health and Safety Studies

AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule.

SUMMARY: This rulerequires the submission ofunpublished 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) ofthe Toxic Substances Control Act (TSCA], 15 U.S.C. 2607(d). The Administrator will issue amendments in the Federal Register to add to the listof chemicals subject to the rule. Amendments to add chemicals recommended fortesting by the Interagency Testing Committee (ITC), established under section 4 ofTSCA, will be effective upon publication. Amendments to add other chemicals willbe subject to a thirty-day comment period. This notice promulgates the final version ofregulations 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 ofToxic 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 USA (Operator-202-554-1404).
SUPPLEMENTARY INFORMATION: OMB Control Number: 2070-0004. Background

In the Federal Register ofJuly 18, 1978 (43 FR 30984), EPA promulgated a previous version ofthis rule under section 8(d) ofTSCA (43FR 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 ofthat rule were the subject ofa lawsuit, Dow Chemical Companyv.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

on a chemical from companies that do
notmanufacture, process or distribute that chemical. The Court upheld EPA's authority for both provisions. Purpose and Use ofthe Rule

Under this rule, EPA will acquire unpublished health and safety studies

on specified chemicals from manufacturers and processors of the chemicals. The Agency will use the studies to support its investigations of the risks posedby chemicals and, in particular, to support its decisions whether to require industry to test chemicals under section 4 ofTSCA. The addition ofchemicals to the rule will

occur by notice ofamendment in the Federal Register. In the case of chemicals recommended for testing by the ITC, the amendment will be effective thirty days after publication. For other chemicals, the amendment will be subject to a thirty-day public comment period before promulgation.

Studies ofhealth and environmental effects, including studies ofexposures of people or the environment, are the fundamental ingredients ofany assessment ofchemical risk.For this
reason, EPA will require reporting under this rule for specific chemicals that are under investigation either in early stages ofrisk assessment orwhen 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 sbction 4 ofTSCA. EPA will evaluate the studies reported under this rule together with other available data to construct a picture ofthe effects of chemicals and their associated risks.

The studies submitted under the previously issued section 8(d) rule (43 FR 30984, July 18, 1978], have been very useful in the Agency's investigation of the effects ofthe ITC-recommended chemicals covered by that rule. The studies have been used in designing appropriate tests, and in support ofthe

- basic decision whether testing for a particular biological effect shouldbe carried out. For example, studies submitted on chlorinated benzenes contributed significantly to EPA's design of a testing scheme formutagenicity. The Agency, itself, will conduct these
tests. Similarly, studies submitted on monochlorobenzene supported our decisions on the need for testing ofthe reproductive effects ofthat substance. These are examples oftwo important contributions that submitted studies can make to testing decisions.

, Overview of Rule Requirements

Extensive comment was received on the question ofwhat records a company should search to comply with thisrule. The proposal spoke of information "known to" or in the "possession" of respondents. The definitions given for these terms were broad, and comments indicated that, under these definitions, companies would feel obliged to search many more records than we believe necessary. We have decided to replace the definitions with a description of the scope ofa search that will be adequate forthis rule. The rule now says that respondents are responsible for searching only the company files in' which they ordinarily keep studies and the records kept by employees whose assigned duty is to advise the company

on health and environmental effects of chemicals. Moreover, for all compliance purposes, respondents need not consult any records that they retired prior to December 31, 1979, the date on which this rule was proposed.

The rule has two basic requirements: Submission ofcopies of studies in the possession ofpersons subject to the rule and submission of lists ofstudies 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 ofstudies forthat 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 forthe chemical (three years after the chemical is made subject to the rule) to

cover studies begun during that period, and to cover persons who begin, or are proposing to begin, manufacturing or processing a listed chemical during that period.

Persons who are not involved with a chemical when it is listed but manufactured orprocessed it or proposed to do so any time during the
ten years prior to the time it is listed, are required to submit copies ofstudies for that chemical, but are not required to list studies.

Since the proposal, changes have been made regarding the types of studies that
must be submitted. Several types have been exempted. The final requirements represent the Agency's effort to reduce the burden ofthe rule while still obtaining the most useful studies forour assessments. EPA received many good
comments that allowed theAgency toNo. 171 / Thursday, September 2, 1982 / Rules and Regulations 38781

identify the studies thatwere most burdensome to submit and least useful for its assessments. Therefore, the Agency has added to the exemptions originally proposed.The final rulehas the following overall exemptions: (1) Physical and chemical properties other than ten that are specifically listed; (2) studies of a substance ormixture that a person has manufactured or processed,

or proposed to manufacture orprocess
as an impurity; (3)published studies; (4) non-confidential studies submitted previously to another Federal agency; (5) all studies previously submitted to EPA (this includes studiesvoluntarily submitted during section 4 proceedings

or under the previous section 8(d) rule); (6) studies ofchemical substances which

are not on the TSCA Chemical Substance Inventory, i.e., research and development studies on new chemical substances, and (7) underlying data such

as medical records, monitoring data, and lab notebooks (unlessthe EPA requests the data later, by personal letter). In addition, certain types of studies of mixtures are exempted as stated below.

In summary, the reportable studies

are: (1)Studies oflisted chemicals with the seven exclusions noted above; and (2] studies ofmixtures containing listed chemicals with the seven exclusions noted above and also excluding: acute oral toxicity studies, acute dermal toxicity studies, acute inhalation toxicity studies, primary eyeirritation studies, primary dermal irritation studies, and physical and chemioal properties. Organization ofThis Preamble

EPA received more than 100 responses to the proposed rule, each containing multiple comments. Several aspects of therule received numerous comments; other aspects, only one ora few.In this preamble, the Agency discusses themajor comment areas: specific definitions; chemical substances subject to therule; lists and copies to be submitted and who should submit them; studies not subject to mandatory reporting; file search; reporting schedule and sunset provision; confidentiality; and economic impact. The subjects that received only one ora few comments

are individually discussed in a document entitled "General Comments

on theProposed Section 8(d) Rule" which ispart ofthe public record.
1.Specific Definitions
A. ManufactureandProcess for Commercial Purposes EPA interprets the term "manufacture

or process for commercial purposes" to refer to such activities conducted, in whole or in part,for the purpose of obtaining a commercial advantage for the manufacturer or processor as distinguished from charitable or academic purposes. Therefore, chemicals manufactured for product research and development (R &D), as well as byproducts and impurities of commercial manufacturing and processing, are "for commercial purposes."

EPA received comments saying that the Agency's interpretation is wrong because these substances themselves

are not actually marketed, and, in the

case ofbyproducts and impurities, are not desired for the market. However, the Agency considers it undeniable that products ofcommercial endeavors are made for commercial purposes. Moreover, the reason that section 8 of TSCA exists is to give the Agency

access to information from which it can

assess the nature and significance of chemical hazards and risks. TSCA is intended to address these hazards and risks to health or the environment whether or not the chemicals are desired commercial products.

The commenters thought that the Inventory Rule exempted reporting of byproducts, impurities, and R &D chemicals because they were not considered to be "for commercial purposes." On the contrary, this section 8(d) rule is completely consistent with the Inventory rule, both rules define these chemicals as "forcommercial purposes." The Inventory Rule exempted such substances only because they were not appropriate for inclusion in the Inventory. In this final rule the Agency has limited thepotential reach ofthis interpretation. A description of the applicability ofthe rule to impurities, byproducts, and R & D chemicals follows.

(1) Impurities.Under this rule, EPA has excluded fromreporting any studies ofchemicals that the person reporting has manufactured orprocessed orhas proposed to manufacture orprocess 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 ofsearching for them. However, in other circumstances, the Agency may propose to require the excluded studies to be reported for some chemicals.

(2) Byproducts.It shouldbe noted that the definition of "manufacture for commercial purposes" includes only byproduct substances and mixtures-that

are separated from the other substance or mixture that is being manufactured, processed, used, or disposed of.Other substances that are produced as byproducts, butnot separated from the product, are impurities oftheproduct and are thus notcovered in the present rule.

This rule requires manufacturers of these separated byproducts to report studies on them and on mixtures containing them. Thus, persons who manufacture a listed chemical as a knownbyproduct that they separate during manufacture, processing, use, or disposal ofanother chemical must report studies on the known byproducL EPA equates these studies with studies ofthe same chemicals as desired products. The studies will bejust as telling on the effects ofthe chemicals.

(3)R & D Chemicals.The Third Circuit has upheld EPAin its view that substances manufactured forR & D purposes are manufactured for commercial purposes,Dow v.EPA, 605 F. 2d 673 (3rd Cir. 1979). EPA discussed the importance of these studies in the preamble to the proposed rule and continue to regard them as important

resources in investigating the effects and risks associated with substances. However, to minimize the burden ofthis requirement, EPA has exempted persons fromreporting studies on chemical substances that are not on theTSCA Chemical Substances Inventory, e.g.,
new chemical substances. When a premanufacture notice (PMN)is submitted on a new substance, any health and safety data on the substance would be submitted.
B.ProposetoManufacture,Process, or Distribute "Propose to manufacture, process, or distribute" is defined in this rule to

mean that a person has made a management decision to commit financial resources toward the manufacture, processing, or distribution ofa chemical substance ormixture. A company could commit financial

resources by, for example, hiring additional personnel, commissioning a construction engineering plan, purchasing land to construct manufacturing orprocessing facilities, purchasing production equipment, or contracting forraw materials.

One commenter stated that EPA should exempt persons that propose to manufacture, process, or distribute the listed substances because they would not have many studies. EPA has not adopted this suggestion. Valuable studies might be missed ifthese persons
are exempted. The Agency would be particularly interested in the results ofa Federal Register / Vol. 47,38782 Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations

study which prompted a decision not to manufacture, process, or distribute a substance.

Some commenters felt that the proposed definition covered actions too early in a company's deliberations and that "propose to" should not hinge on a management decision 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 ofthe substance. These actions are considered here as "proposed" manufacture.

Other commenters asserted that the meaning of "propose" is clear in the premanufacture notification provisions ofsection 5 where the requirement is to submit the notice at least ninety days before production. EPA disagrees. Section 5requires a notice when a person "intends" to manufacture a new chemical substance, not when he "proposes" to manufacture. When a person isready to submit a section 5 notice, he is beyond the initial stage in which he "proposes" to manufacture for
purposes ofsection 8.

The Agency has not changed the definition.The Agency believes it is as specific as a definition ofsuch a concept

canbe, given the variability of businesses covered.

C.HealthandSafety Study

Many commenters argued that some ofthe examples ofhealth 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 ofeffects 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 ofa chemical's concentration in the workplace or environment. Another kind

was measurements of properties of chemicals, such as: biological, photochemical, and chemical degradation; air, water,and soil transport; and water solubility, vapor pressure, and octanol/water partition coefficient.

The Agency disagrees with this

narrow view. The legislative history of TSCA indicates that Congress expects the Agency to collect a broad range of information relevant to health and environmental effects.

It isintended that the term (healthand safety studies) be interpreted broadly.Not only isinformation whicharises as aresult of

a formal, disciplined study included,but other iliformation relating to the effects ofa chemical substance or mixture on health and the environment is also included. Any data whichbears on the effects ofa chemical substance onhealth orthe environment wouldbe included.H.R. Rep. No.94-179, 94th Cong., 2nd Sess. 58 (1976) (Conference Report).

All ofthe data EPA willobtain under this rule, bear on the effects of chemical substances on health or the environment.

When measurements of a chemical's concentration havebeen analyzed to draw conclusions about occupational or environmental exposure, a "health and safety study" has been done. Similarly, determinations ofphysical and chemical properties that relate to a chemical's potential foraffecting health or the environment are "health and safety studies."

(1)Measuresofconcentration.The final rule requires the submission of analyzed aggregates ofmeasurements monitoring concentrations of a chemical in the workplace or environment. These

are limited to analyses ofdata gathered within five years ofthe effective date for reporting on the chemical. These studies bear significantly on the effects of a chemical onhealth or the environment. Forinstance, iftheAgency knows that a chemical neverreaches the environment, itwould know that itwill
nothave an effect on the environment.

Some ofthe concerns commenters had about submitting monitoring data were because they understood the proposal to say that allunderlying data were to be initially submitted.This would have
meant submitting a very large amount of material. As explained below, underlying data arenot to be initially submitted.

(2)Properties ofchemicals.The final rulerequires reporting on studies often properties when those studies are for thepurpose of determining the environmental orbiological fate ofthe 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 ofa chemical are very important elements to consider in assessing its potential biological effects. Forexample, water solubility and partition coefficient bear on the question ofwhether a chemical could become deposited in body fat tissues. For another example, all of the properties

are informative on the questions of whether a chemical released into the environment would remain for a long time and be transported over a large

area.

EPA decided to narrow the requirements for submitting properties in an effort to reduce the reporting burden. There are other properties that

are very useful,but the Agency focused

on these tenproperties as being particularly informative, individually and together.

Determinations ofphysical and chemical properties, together with the other studies, will give a picture ofthe chemical's exposure and effects which will permit effective evaluation of potential risks. An evaluation ofthe environmental fate ofa chemical, which isbased on physical and chemical ,properties, thatinay be released to the envirionment is ofcritical importance. It is possible that a highly toxic, easily degradable substance will be less an object ofconcern than a less toxic, persistent chemical. Recent technical reports have indicated the importance of environmental fate testing.

For chemicals that are likely to bereleased
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 ofwidespread environmental contamination. (See Howard, P.H., et. al. Environmental Science andTechnology, 12(4), 407 (1978)).

Determining the fate ofa chemical substance in the environment and,thus, its effects, may involve investigating the

nature ofdispersal 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 ofthe importance ofphysical and chemical properties in determining the environmental effects ofchemicals.)Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations 38783

(3)Underlyingdata.Data such as Individual monitoringrecords or employee medical records that may underlie an epidemiological or exposure study are not required tobe submitted

as initial reports underthe rule. EPA mayrequest these and other underlying data such as lab notebooks as a follow up to its examination ofa study.The Agency does not anticipate making such requests very frequently. Itwill do so when a question ofinterpretation arises (such as when theAgency has studies whose results appear to conflict) and an examination ofthe underlying data may clarify theproblem.
D.Known toandPossession

Aspreviously discussed, theAgency has decided to delete definitions of "knownto" and "possession" and, instead, describe thekind offile search that will suffice for compliance withthis rule.From commentsreceived on the. proposed definitions, itis apparent that the definitional approach to delineating

a responsibility to search for studiesis too indirect. Thematter is discussed further under thepreamble section titled "File Search."
II.Chemical Substances Subject to the Rule

Section 716.17 ofthe rule contains a list of chemical substances subject to therule. A subsection of §716.17 is reserved forfuture listing ofdesignated mixtures subject to therule.

The majority ofthe chemicals presently listed are ones for whichthe ITChas recommended that EPA propose testing rules.Itis important that EPA review unpublished studies on these chemicals to avoidunknowingly proposing testing under section 4 that mayalready have been done, and to basejudgments about testing on as full

an overview ofexisting information as practicable. The goal is to focus proposals fortesting as efficiently as present knowledge willpermit.

The list in §716.17 contains two groups of chemicals. One group consists ofthe chemicals recommended by the ITCfor testing. The other group of chemicals includes the asbestiform varieties of chrysotile,crocidolite, amosite, anthophyllite, tremolite, and actinolite, i.e., asbestos, which is being considered forcontrol.

The bisazobiphenyl (BAB) dyes were recommended for testing, and are the subject of a broader Federal effort. Assessment actions are underway at CPSC and OSHA. In addition,the BAB dyes are being tested by CPSC (skin absorption) and at the National Center for Toxicological Research (metabolism studies). Several chemicals in the proposed list have been removed in the final rule.A subset ofone category ofchemicals, listedin the proposal as "organotins" (selected byEPA) was subsequently recommended fortesting by theITC, 45 FR 78432 (November 25, 1980). The ITC had recommended the subset "alkyltins." However, the ITChas subsequently removed this category from the section 4(a)Priority List for reconsideration (47 FR 5459). EPA has deferred reporting on these and the other organotins for a laterproposal. Another category ofchemicals, acrylic acid and methylacrylic acid and their esters, has been removedfrom therule. EPA willpropose the category in a future iteration ofthis rule after it has better defined the category.Dioxin and related substances have also been removed from the rule. Since proposing theirinclusion in this rule, the Agency has carried out administrative proceedings dealing with dioxinissues which have covered the ground that would have been covered by having the chemicals reported underthis rule. Other chemicals removed from the rule include acrylonitrile, alphachlorotoluene, benzene, benzene (epoxyethyl), chlorendic anhydride, chlorodifluoromethane, 1,2- dichloroethane, 2-chloro-1,3-butadiene, ethyl benzene, iodomethane (methyl iodide), morpholine, nitrosodiethanolamine, 2-nitropropane, and vinylbenzene (styrene). These chemicals were removed for a number ofreasons. Some (e.g., benzene, styrene)

were the subject ofearlier section 8(e] submissions and have since been referred to other EPA program offices or Federal agencies for study.The remainder were under early stages of assessment when they were added to the proposed rule. Inthe intervening time, however, the Agency has brought

some ofthese assessments to near completion, e.g., 2-nitropropane.

Several comments argued that EPA did notprovide adequate public notice and opportunity for comment because the Agency did not state in its proposal

a reasoned explanation ofhow orwhy each particular chemical was selected. These comments said that theAgency must, foreach chemical, showthat the information to be reported will contribute to articulated regulatory objectives. Inparticular, they stated that EPAmust show whyit believes that each chemical might pose a riskto health or the environment and why published studies provide insufficient information for conducting a risk assessment, evaluating the needfor testing, or considering other regulatory options. These comments also claimed the Agency must show for each chemical subject to therule that the information requested is not available from other sources.

EPA believes it hasjustified, to the extent required by section 8(d), theneed forreporting on the chemicals subject to the final rule. The Agency disagrees with the comments on thelevel ofdetail required tojustify reporting. The comments would require that the Agency prepare an extensive chemical specific determination that would require a search ofthe entire scientific literature and all available sources and

a complete hazard analysis ofthe chemical.Thus, according to the comments, section 8(d) could be used only to obtaininformation as a last resort.This is contrary to theintent of TSCA. There is nothing in the language

orlegislative history oftheAct to indicate that section 8(d) is to be used in such amanner. On the contrary, section 8(d)is meant to reveal information early in the investigation phase. (SeeReport ofthe Senate Committee on Commerce, S.Rep. No. 698,94th Cong., 2d Sess. 8 (1976).)

TSCA requires theAgency to provide only a general explanation of its concern before requesting unpublished studies

on a chemical under section 8(d). Sufficientjustification is provided ifthe chemical is recommended fortesting by the Interagency Testing Committee or if EPA staffjudges that further data on the chemical are needed for assessment. EPA shouldnot ignore the possibility of obtaining data under section 8(d) when

a chemical is under evaluation by the Agency staff.

EPA particularly disagrees that it must show during a section 8(d) proceeding that a chemical may present

arisk. Congress could nothave intended the Agency tomake arisk finding under

a section ofthe statute that is designed
to reveal thehazards ofa chemical.

As to the comment that EPA must indicate for each chemical that information required by this rule cannot be obtained from othersources, the final rule in fact accommodates this comment by excluding from rule requirements any studies available from sources to which EPAhas access-published studies and studies submitted to other Federal agencies without confidentiality claims. The studies subject to the rule are those not otherwise available to the Agency.

Several comments argue that to provide adequate public notice and opportunity forcomment EPA must in the proposed rule state for each chemical subject to section 8(d) that the information requested is notmore detailed orextensive than necessary,38784 Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations

and willnot burdenmore persons than necessary withreporting obligations.

EPA concurs that as a matter ofsound policythese factors should be considered bythe Agency for this section 8(d) rule,but disagrees that it

canprepare detailed assessments of these factors at the timeit proposes a section 8(d) rule. Infact, EPAhas proposed this rule to solicit from the companies that obtain commercial advantage from the subject chemicals
comments on whether reporting on their particular chemicals willbe unnecessarily burdensome. These companies have or should have the knowledge to enable theAgency to make this decision. Indeed, the Agency has, in response to comments, eliminated some types ofstudies and

some chemicals that were originally part oftheproposal.

Many comments objected to the Agency's automatically making subject to therule chemicals recommended for testing by the ITC. These comments claim that recommendation for testing by the ITCis not sufficient tojustify an automatic reporting requirement. They argue that EPA must allow thepublic to presentreasons why unpublished studies shouldnot be collected in order to avoid imposing unnecessary or overly burdensome reporting requirements. The
comments stated the following examples ofsituations inwhich the public should be able to comment onEPA's decision to obtain studies underthis 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 orabandon testing on thebasis ofinformation 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 ITCmay have overlooked a crucial study in the literature; voluntary testingmay have been initiated or all manufacture and processing may have ceased.

EPA does not find this reasoning persuasive. Within one year after the ITCrecommends a chemical for testing, theAgency must initiate a rulemaking proceeding to require testing under sectioxi 4 ofTSCA or publishits reasons fornot initiating such a proceeding. Because ithas such a short period of time to make this decision, theAgency mustproceed as rapidly as possible to gather available data on a chemical.

To decide whether to propose a test rule within oneyear, the Agency needs tobe able to complete its assessment of the knownhealth and environmental effects ofa chemical no later than the firstfour to five months after the ITC recommendation. Ifstudies are reported automatically under thisrule, the Agency will receive them bythe 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, EPAwriting of responses to the comments, and EPA preparation and publication of a final rule. The Agency would then receive the studies by the end ofthe sixth or seventh month after the ITC recommendation. However, by this time EPA staff must complete their analyses forEPA decisionmakers to consider. EPA has previously discussed in this preamble theimportance ofsection 8(d) studies in deciding whether to initiate proceedings to require testing and has discussed examples showing that unpublished studies submitted previously havebeen valuable in section 4proceedings. Receipt of significant studies at this late stage that could cause fundamental revision ofthe basic analyses would make it impossible to meet the Agency's oneyear deadline.

The Agency has also considered in this section 8(d) proceeding a large number ofissues relating to reporting of unpublished studies. The Agency has been unable to determine, and no comments have beenpresented to indicate, that any other issues would be raised In a commentperiod that would lead the Agency not to require section 8(d) studies on ITC-recommended chemicals. Most of the examples described above ofsituations in which thepublic should be able to comment on decisions under section 8(d) on ITC chemicals are'reasons why chemicals should or should not be tested under section4. This section 8(d) rule is notfor determining whether to proceed with testing under section 4,butis to be used to obtain information to assist in section 4decisions. Most ofthe situations described by the comments, therefore, would not be relevant to a section 8(d) proceeding.

Further, EPA willnot 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, all companies willnot do so. Inquiring after voluntary submissions is a highly inefficient use ofAgency time and

resources and would unnecessarily delay input into the section 4testrule process.

EPA's economic analysis shows that the costs ofsearching for studies on ITC chemicals in accordance with the procedures setforth in this rule willbe very small. Further, the Agency expects that in the future companies will establish a system to enable more efficient retrieval ofstudies requested under section 8(d). After considering these costs against the relatively quick needthe Agency has for studies ofITC 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.
III. Lists and Copies to be Submitted and Who Should Submit Them

The rule includes two types of submission requirements-the requirement to submit copies ofhealth and safety studies, with an appropriate index, and therequirement to submit lists ofcertain additional health and safety studies.
A. Requirements forSubmitting Copies ofStudies

Tworequirements to submit copies of studies will apply.First, any person who has manufactured or processed or who has proposed to manufacture orprocess
a substance or designated mixture listed in §716.17, within the ten years preceding and including the date the chemical is listed,will be required to submit copies ofany unpublished studies he possesses on that chemical. Second,EPA mayrequest copies from persons other than manufacturers and processors ofthe chemical when such persons are identified as possessing studies listed by someone else in accordance with §716.12. Such persons would be requested to submit these studiesvoluntarily, but would be subject to subpoena under section 11 ofTSCA if they do notdomply.

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 mustreport (except distributors).

Many comments suggested ideas for limiting the persons subject to the rule and limiting the types ofstudies to be submitted. These ideas were:

(1)Limit the copy submission requirement to past and present manufacturers, processors, and distributors ofthe 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 laterFederal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations 38785

request any person, who is listed pursuant to §716.7 as possessing a study, to submit that study.

(2) Limit the copy submission requirement ofpast manufacturers to those who have manufactured since 1965, 1970, 1975, orpresently manufacture instead of since 1950 as proposed. The commenters maintain that these "cut-off" dates would tend to reduce the volume ofstudies collected and would maximize the quality ofthe studies being collected since, in the commenters' view, older studies tend to be ofless value.

EPA retained the reporting requirements forpast manufacturers and processors because they are just as likely to have good studies as present manufacturers and processors. EPA proposes the January 1, 1950 date because persons who have dealt with the chemical and performed studies in the last thirty years would have utilized

more advanced analytical techniques. The Agency received comments basically agreeing with EPA's view that there is a time in the past beyond which techniques were not so good as they are

now. However, commenters suggested cut-off dates from 1965 to 1975, with
most commenters suggesting 1970as a cut-offdate because they believe that information more than ten years old may be outdated and oflittle value.

Commenters agree that more advanced analytical techniques were used after 1950, but they maintain that most ofthe more sensitive detectors and techniques forgas chromatography, atomic absorption spectroscopy, and infra-red spectroscopy were developed during the last decade.

For instance, the late 1960's saw the first commerically available liquid chromatography unit, while the first gas chromatography unit with infra-red spectrophotography was not available until 1972. Also, many ofthe screening
tests used today, such as the Ames Test,

were developed during the last decade. The commenters were persuasive that thirty years is inappropriate and that a shorter time span would be appropriate. Therefore, the final rule states the period as ten years prior to the effective date for reporting on a chemical. This will keep the ten-year period constant for the future. Holding to the 1950 date would resultin an ever-lengthening span

as this rule is used in the future.

Most ofthe concerns expressed about the long time span were concerns about companies potentially having to search retired files either for studies or to find
out whether the company had dealt with the chemical in the past. To avoid this problem ofretired files, the Agency has specified in the rule that a company need only consult its records not retired prior to December 31, 1979, either for studies or for answering the question of whether it dealt with a chemical in the past. The morevaluable, older studies will likely havebeen preserved in current files, rather than being retired. In addition, searching long-retired files could be vqry costly; too costly for purchase of thisrule. December 31, 1979 is the date on which potential respondents to this rule were puton notice oftheAgency's intention to require thisreporting, and it is therefore

an appropriate date to define the limits ofthe file search.

(3)Limit the rule to persons who reported the chemicals for the Inventory. This would reduce the company's burden in determining its responsibility under a section 8(d) rule merely to checking the list ofchemicals it reported for theInventory, and would yield the higher quality data developed by the manufacturer orprocessor.

EPA did not adopt this suggestion for tworeasons. Complete reporting for the Inventory waslimited to manufacturers whereas section 8(d) also applies to processors. In addition, theimplicit assumption that only those who reported for theInventory would have a list oftheirInventory chemicals is not valid. All manufacturers and processors ofchemicals must know ifthe chemicals they make are on the Inventory, whether they reported for theInventory or not. Theymust know, because they must submit a premanufacture notice to EPA under section 5ofTSCA, before making

orprocessing a chemical that is noton the Inventory.

(4) Decrease theburden ofsection 8(d) rulemaking and subsequent regulations by asking major manufacturers voluntarily to submit studies.If manufacturers refuse to do so,then the Agency could proceed with section 8(d) rulemaking, orgo directly to section 4 rulemaking.

EPAdid not adopt this suggestion. Although some companies may submit certain studies voluntarily, it is important that EPA receive allrelevant studies. Only a section 8(d) rule can
ensure this. In addition,many commenters stated that many studies contain trade secretinformation which companies are very reluctant to submit voluntarily.

(5)First require lists or titles of studies that havebeen performed by manufacturers orprocessors ofthe listed chemicals and thenlater request copies ofselected studies.

This suggestion was not adopted because insufficient information is contained in the titles of studies to give

a basis for study selection. (6) Limit initial reporting to key studies relevant to specified effects (such as those the ITC recommends be tested) in order to produce studies most valuable to risk assessment, and to reduce reporting burdens and EPA's review burden.

This suggestion was not adopted.EPA plans to investigate a full range of properties and effects ofthe listed chemicals. Effects ofa substance are not discrete items, unrelated to one another. On the contrary, certain effects and properties are predictive of other effects and properties. For instance, fate and persistence studies will help in predicting environmental effects. Acute toxicity studies generally provide data
to determine the median lethal dose (LD50) of a chemical substance (its relative toxicity), but also may provide data tojudge its mode(s) ofaction, to determine its specific toxic effect(s) on target organs and functions, and to determine the existence and extent of species differences in sensitivity to a chemical. Acute effects studies designed
to measure potential ecological 'effects

are especially valuable since there is comparatively less information in this field than in others. Also, the submission of acute effects studies will be used to determine the need for and character of acute effects testing rules.

A broad range ofstudies is well recognized as necessary tojudge the adverse effects ofa chemical substance. For example, the Organization for Economic Cooperation and Development (OECD) has developed a base set ofrecommended tests containing arange oftests ofphysical and chemical properties and toxicity for assessing the hazads ofchemicals. 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 ofa particle can,in itself,be indicative ofits carcinogenic nature (e.g., asbestos fibers) and the partition coefficient is indicative oflikely accumulation in lipid tissues." OECD Chemicals Testing Programme, Expert Group, Physical Chemistry, Final Report Vol. I,p.41. In addition to physical and chemical properties, the OECD has also included many acute, subacute, and chronic tests in thebase setof tests.

(7) Limit the chemicals subject to the rule to "high priority" chemicals such as ITC chemicals to match exactly the ITC recommendations and reduce the reporting burden,

EPA did not adopt this suggestion. The chemicals recommended by the ITC may be in fact the majority group on the38786 Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations

rule, but they arenot the onlychemicals

on which EPA willneed studies. The hazards of other chemials are and will be under investigation.
B.Requirements forSubmittingListsof Studies

The final rule adopts the proposed requirement that only current manufacturers and processors oflisted chemicals and those whopropose to manufacture orprocess these chemicals
must submit lists ofstudies.

Several comments objected to listing records kept on employees exposed to chemicals. They assert that record systems and data do notconstitute a study unless an intention to correlate certain data to evaluate results and reach conclusions is declared. A record listing requirement would move the scope ofthe requirements into therealm ofconjecture, and render the proposal, in this respect atleast, impracticable,

even ifthe thrust ofthis listing requirement falls withinTSCA's authority. Quite simply, according to the comments, there is no way to determine towhich particular chemicals any given employee might be exposed. Interpreted literally, thisrequirement would encompass the records forall employees, a result surely not intended bythe EPA.

The Agency agrees and has modified the proposed listing requirements. The studies tobe listed do notinclude record systems.Persons willnot have to list medical record systems or daily or routine monitoring records. These types ofdata could constitute underlying data for an epidemiological study for example, but are notby themselves treated as studies.

Other commenters asserted that protocols forongoing studies shouldnot be submitted, as the proposed rule would have required, since protocols are nothealth and safety studies and contribute norelevant health and safety information regarding chemicals.

EPA has adopted the limitations suggested. Copies ofprotocols do not have to be submitted since they will usually be described in the study eventually reported.

Some comments objected to listing ongoing studies. Theymaintained that section 8(d) applies only to completed studies.EPA disagrees with this comment. Section8(d) authorizes listing ofa study "conducted or initiated by or for" a company. EPAmay require listing

once a studyhas begun because it has been "initiated" within themeaning of the statute.

A few comments questioned theneed for listing ongoing studies and for submitting preliminary reports, if requested, when an ongoing study is listed. They asserted that partial and incomplete data can be extremely misleading. Also, they said a scientist should not be required to disclose the results ofhis research until the scientist is satisfied with the accuracy, reliability, and scientific significance ofthe data.

The Agency disagrees. Itrequires a list of ongoing health and safety studies
to tailor testing rules to fill real gaps in knowledge. Ifindustry has started enough research of a particular type, the Agency could exclude that type of testing from a testing rule or delay it until the test data are available to the Agency. For chemicals for which testing is not contemplated, the submission of lists ofongoing studies will help the Agency determine the scope ofpossible control regulations. If, forexample, the Agency is considering control ofa particular use ofa substance, the knowledge that a person is testing that substance to determine its effects or potential forexposure to man or the environment would be valuable information.

The Agency will not routinely require preliminary reports to be submitted. However, under procedures stated in §716.8, EPA may ask for the submission ofpreliminary reports when necessary. The Agency understands the concern a scientist mighthave about releasing preliminary data. However, sometimes it is necessary to track the progress ofa 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 topropose a testing rule

or take regulatory action that might be found to be unnecessary when the final
test results are reported.

IV. Studies Not Subject To Mandatory Reporting

A. Exemptions forStudiesof Mixtures
The proposed rule provided four' exceptions to the reporting requirements. Persons did not have to submit: (1) Copies or lists ofpublished studies; (2) copies ofstudies previously submitted to Federal agencies with no claims ofconfidentiality; (3)copies of studies conducted by other persons subject to the rule; or (4] copies orlists ofstudies ofmixtures containing small
amounts oflisted substances when the studies clearly did not reflect effects of the listed substances. Comments addressing items (1)through (3)above, and EPA's responses, appear in "General Comments on the Proposed Section8(d) Rule."

The exemption for reporting mixture studies (number 4 above) generated the greatest number ofcomments. The commenters were almost evenly divided

on whether theproposed exemption or a modified version ofit should appear in the final rule. Some comments stressed the difficulty ofpredicting the effects of

a single component of a mixture from results obtained from testing the entire mixture. Therefore, they suggested the Agency should not require the submission of any mixture studies.

Other comments. suggested that the Agency fine-tune the exemption by requiring only submittal of a study on a mixture containing a listed chemical when the study wasundertaken for the express purpose ofdetermining the effects ofthe listed chemical orwhen data in the study were originally aggregated and analyzed in a manner that directly and specifically relates to such effects.

Weighing all ofthe 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 oftheproposed exemption, theAgency has provided exemptions for:

(1)Physical and chemical properties ofmixtures;

(2) Certain types ofacute studies on mixtures; and

(3)Certain aggregations ofmonitoring data onmixtures. See §716.11 (e) through (h) oftherule forthe particular studies that are not subject to reporting. The remaining studiesto be reported mustbe reported regardless ofthe submitter's view ofwhether the studies reflect effects ofthe pertinent substance. EPA will make thisjudgment. By expanding thelist of studies that do not have to be submitted and removing the review necessary to determine which mixture studies shouldbe submitted, the reporting burden onpersons will be significantly reduced.
B. "Substance"Versus "Mixture"

In thefinal rule (§716.4), EPA clarifies how certain preparations of substances shouldbe treated.For example, one commenter indicated that he considered

an aqueous solution ofa substance tobe

a mixture. Since one often puts a substance into aqueous solution before testingit for biological activity, the commenter's view could result in many testsbeing reported as tests ofmixtures. This would be an absurd result in the context ofthis rule. Studies ofthe following preparations ofa chemical substance mustbe reported as studies of the chemical substance itself,notas studies ofmixtures containing the substance:No. 171 / Thursday, September 2, 1982 / Rules and Regulations 38787

(1)The chemical substance in aqueous solution.

(2) The chemical substance containing

a small amount of an additive, such as a stabilizer, emulsifier, or other chemicals added for purposes ofmaintaining the integrity orphysical form of the substance.

(3) The chemical substance at any grade ofpurity.

Studies ofthese preparations of substances are classified forreporting

as studies ofthe substance. EPA does not, and need not, at this time reach the issue ofwhether these preparations are defined as mixtures or chemical substances under TSCA.

V. File Search

Because of the considerable confusion

on the part ofcommenters 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 ifthey limit their search for information to files in which such information is expected to be found in the ordinary course oftheir business, and the files ofemployees Whose assigned duty is to advise the company

on thehealth and environmental effects of chemicals.

The actual mechanics ofthe search

can be approached in a number ofways depending on the size ofthe company and the type ofchemicals forwhich studies will be submitted. EPA includes the following discussion to convey how it believes a satisfactory search might reasonably be conducted with the least expenditure ofresources. TheAgency is
not saying that this ishow companies
must search.

For small to medium size companies that believe they are subject to the rule and have few studies ofany kind, it may be more cost effective to scan the titles ofthe studies they possess and then check to see ifthe chemical studied is

on the list ofchemicals subject to the rule. EPA's experience has been that smaller companies submit few studies and will find it easier to match studies against the chemical list. Large companies might use the same approach depending on how their files ofstudies

are indexed. Alternatively, they might determine the chemicals theyhandle(d] then search forstudies.

The Agency expects the search for physical and chemical properties to be minimal for all companies because of the very limited number ofproperties that are subject to the rule. Also, the Agency expects that companies will have a special reference file for the most standard properties such as solubility or vaporpressure. For other, special purpose properties, such as octanol/
water partition coefficients and degradation properties, the company will not be determining these on a routine basis and should be able to check with one or two key personnel to

see ifthese studies were performed.

Companies possibly subject to the rule because a listed substance is a component ofa mixture should be able
to examine the mixture studies they
possess to see ifany components of the mixture studied are on the section 8(d) chemical list. Since most ofthe studies normally performed on mixtures are exempted by the rule, most companies will onlyhave to examine a handful of subchronic and chronic studies on mixtures to determine which studies should be submitted.

VI. Reporting Schedule and Sunset Provision

Persons must submit lists and copies ofstudies no later than sixty days after the effective date ofpromulgation ofthe list ofchemcial substances and mixtures in J 716.17. Therule also provides for extending the submission deadline for a reasonable period, ifa company requests such an extension because of long file searches.

Because they assumed a very extensive file search was required,
many commenters suggested that sixty days was insufficient time to comply with the rule. EPA is retaining the proposed schedule becau~se it has made significant changes to reduce the search burden. The scope ofthis final rule is less than that of theprevious section 8(d) rule under which companies reported in 1979 since many exemptions
to the required studies and the responsibilities ofrespondents have been made. No company requested an extension oftime forreporting under the rule's sixty-day schedule. Based on the 1979 experience, and because ofthe reduced scope ofthis rule, the Agency believes that sixty days is an appropriate period.

As proposed, the rule would have required thatpersons subject to the list submissionrequirement inform EPAof any study initiated during the five years prior to the sunset date. Comments considered this to be too burdensome since it would require them to search continuously for all new studies. EPA
agrees that the proposed provision was too broad. TheAgency has changed the requirement. Under the final rule, these persons will be responsible only for informing EPA ofstudies initiated by or forthem, rather than of anynew study. This includes studies directly contracted for by the company or studies sponsored through a company's membership in an association that contracts for testing (including trade associations such as the Chemical Industry Institute of Toxicology). EPA considers this to be a reasonable change. Since only those studies under a company's control and sponsorship are covered, there will be

no need for a search; the report toEPA will be made when the study is ordered
to be done. In addition, EPA has limited this continuing reporting requirement to chronic studies; long- and short-term
tests ofmutagenicity, carcinogenicity, or teratogenicity; and the biological and environmental fate tests listed in § 716.10(h) through (j).

Another concern ofthe comments was that the five-year period forreporting completion ofongoing studies or initiation ofnew ones is too long, especially since EPA must act on chemicals recommended by the ITC within twelve months.

The Agency believes that a multiyear period is necessary. The action required within twelve months is to initiate rulemaking, or giveEPA's reasons for
not doing so. Promulgating a testrule or entering into a voluntary testing agreement will require consideration

over a longer period duringwhich new data ofthe initiation ofnew studies could affect EPA's final action. Even after a testrule is promulgated ora voluntary testing agreement is reached,

new data on substances under testwill be important in the Agency's evaluation of the chemical subsequent to testing and could contribute to a decision whether control action for the chemical is indicated. However, to balance EPA's needs against the burden ofthis requirement, EPA has decided to maintain a multiyear approach but to limit it to three years. EPA believes that thisrepresents aminimal reporting burden since the only studies covered by this requirement would be presently ongoing studies which are completed and studies initiated during the threeyear period. Also, the rule now allows the Assistant Administrator to terminate the requirement for reporting about a particular chemical ifhe decides that further reporting is not needed.

VII. Confidentiality

EPA is aware ofthe need to protect confidential business information. Several commenters suggested that the regulations should contain a specific
statement about the means EPA would

use to protect the confidentiality of information in the unedited copy ofa study.

The TSCA Confidential Business Information Securuty Manual contains the'procedures forphysically Federal Register / Vol. 47,38788 Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations

safeguarding confidential business information submitted under TSCA. (Themanual 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 onlyin accordance with these procedures. In addition, all information claimed as confidential is subject to the legal procedures in 40 CFR Part 2with respect to disclosure by EPA.

Aperson submitting a health and safety study may claim all orpart ofthe study confidential. However, health and safety information about a chemical that hasbeen offered for commercial distribution or is subject to testing under section4 or notice under section 5can be withheld from disclosure only to the extent that disclosure would reveal (1) processing information and (2)percent composition ofmixtures, or contains information the disclosure ofwhich would clearly be an unwarranted invasion ofpersonal privacy (such as individual medical records), as provided in 5U.S.C. 552(b)(6).

Any claims ofconfidentiality must be made at the time ofsubmission, as provided in40 CFR 2.203(a)(2) and in the

manner specified in §716.16 ofthis regulation. This rule requires submission oftwo copies ofstudies containing confidential material-one copy indicating what data are claimed as confidential and one copy without the confidential information. EPA will presumptively consider failure to submit the second copy as a waiver ofthe confidentiality claim. However, EPA will notifyrespondents who claim parts of studies confidential that they did not submit therequired second copy.This provision affords persons the opportunity to correct errors within 30 days.

Commenters raised a number of issues concerning specific provisions of theproposed regulation that detail the methods for submitting confidential information.

One assertion was that subrnitters should notbe burdened with "up front" substantiation for claims of confidentiality, and that such substantiation shouldbe required only if EPA receives a Freedom ofInformation Act (FOIA)request for the information.

The Agency willnot require "up front" substantiation.The language of §716.16(c) has dropped therequirement that the basis ofthe claimbe "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 orprocess information, or that the information is clearly irrelevant to the health and safety study. EPA does not expect detailed substantiation ofconfidentiality claims at the time the study is submitted. The Agency believes that this simple statement isjustified, because EPA needs some understanding ofthe claim to have a basis for initial denial or granting ofFOIA requests and to protect the information.

Another suggestion was that failure to provide a nonconfidential second copy ofa study forwhich claims are made should not be considered a presumptive waiver ofthe claim. The commenter asserted that the claim to a trade secret is a property right and cannot be taken
away by the operation ofa presumption. In theirview, 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 shouldbe adequate for such

a straightforward response, even given mail delays, because the only step needed is to provide a second, nonconfidential copy for the public file.

A final specific comment was that the Agency must not allow confidentiality claims for submitted health and safety studies. To do so, is, in the commenter's view, a direct, illegal contradiction of section 14(b) which exempts the results ofhealth and safety studies from such claims.

EPA disagrees that it should not allow confidentiality claims. Respondents may claim any information as confidential; however, the onlyinformation which the Agency may actually keep confidential is listed in §716.16(c).

VIII. Economic Impact

EPA estimates that the total cost to industry ofsubmitting lists and copies of health and safety studies under the present rule is approximately $537,000.

The major cost to a firm willbe the
cost ofa file search to determine what health and safety studies it possesses. This cost will, ofcourse, 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 costsinvolve copying and processing the studies, making lists of studieswhich are in progress ornot in the possession of therespondent, 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 willbe larger or smaller forlarger

or smaller firms. Each ofthese costs is tabulated below.

Total

Corporate rule review

................................... Corporate review (site identification)

........................... File search

............................................................... Title listing

....................................................................... Photocopying (materials)

................ ............... Photocopying (labor)

..................................................... Managerial review

......................................................... Ongoing reporting

.......................................................
Total cost of this rule

. ... ............ $89,000 67,000 121,000

7,000 9.000 28,000 189,000 27,000
537,000

This represents a cost of approximately $2,000 to $4,000 per chemical. When the Agency adds to the list ofchemicals subject to the rule, these cost per chemical estimates can be used to determine the cost of the additional reporting.

Ifthe 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 thisrule. For example, EPA estimates that itwill cost industry from $700,000 to $1,300,000 to perform the proposed testing (see 45 FR 48557) for chloromethane and up to $4,900,000 for chlorobenzenes (see 45 FR 48557).

The Agency received many comments suggesting that its original estimate of $410,000 total cost was too low.The
comments pointed to many features of the proposed rule that they believed would cause much greater burdens than the Agency had assumed. However, only a few comments actually gave EPA estimates ofthe time or money they would expend in complying with the proposal. For example, the Chemical Manufacturers Association suggested from a survey ofthirteen ofits 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 for routine monitoring records and formedicalNo. 171 / Thursday, September 2, 1982 / Rules and Regulations 38789

records. The commenters read the proposal to require submission of these data. However, EPA has made it clear in the final rule that these records are not to be submitted as studies.The Agency may request them in thefuture, but only if they areunderlying data to a study.

(2) The proposed requirement to submit all studies on mixtures containing a listed substance would have caused several problems, according to many comments. The problems would have come in searching through records to determine whether a listed substance could bepresent in a studied mixture and in then deciding whether thelisted substance was responsible forwhatever effect the study showed.

TheAgency has substantially changed the requirements for submitting studies

on mixtures. It has excluded most acute studies from therequirement; it has excluded all physical/chemical properties ofmixtures; and the Agency has excluded studies ofmixtures that contain the listed chemical onlyas an impurity.In addition, theAgency has removed the requirement for respondents to decide whether the effect studied was caused by the listed substance-EPA will make that judgment. These changes should cut the cost ofsubmitting mixture studies substantially. The changes mean that companies can go directly to their copies ofstudies onmixtures to see ifa listed chemical was in a mixture tested. Thenumber ofstudies to belooked at has beenmuch reduced. And,most importantly, companies will not have to search records to find out what impurities may have been present in the studied mixture.

(3)The proposal would haverequired companies who may never have dealt with a chemical to submit studies on it if theyhad then. EPA has removed this burdenby changing the requirements to apply to those who have manufactured

or processed or haveproposed to manufacture or process the chemical. Moreover, the Agency has said that companies can determine their association with the chemical bylooking at their current files. This will alleviate a

concern expressed by companies whose ownership or activities have changed and whose records have beenretired.

(4] Perhaps the greatest burden cited

was that ofpotentially searching every company file for studies or references to studies. The proposal wasbroadly worded in this respect.The finalrule contains a section describing the much

morelimited search that willbe enough to comply with the rule. Companies will comply ifthey search the files where studies are kept in the ordinary course of theirbusiness, and the files ofthose employees whose assigned duty is to advise the company about health and environmental effects of chemicals.

(5)Comments have requested that studies onresearch and development chemicals be exempted. They requested the exemption fora number ofreasons,
one being that these studies maybe in a different set offiles at different locations than other studies. EPAhas not fullyexempted these studies (see R &

D Chemicals) because, as previously discussed in this preamble, the Agency does not believe that thefact that a studied chemical has beenin research and development isrelevant to thevalue ofthe study. However, by better defining the file searches required for compliance with the rule the Agency has reduced theburden ofsearching forsuch studies.

(6) The report's impact analysis for the proposal didnot include the burden to a company to familiarize itselfwith the rule. Commenters remarked on this, and the Agency has included this item in the final analysis.

(7) Thereport's impact analysis for the proposal did not consider the cost of file searches whichmust be conducted by firms which will not actually find submittable studies in their file. Commenters suggested EPAaccount for these costs.

In the first analysis, EPA attempted to base cost estimates upon the prior experience offirmswhich reported for the original section 8(d) rule. These data did not reflect the experience offirms which conducted futile file searches, and didnot report.The Agency believes that for thepurposes ofa report impact analysis, theprevious experience ofthe prior section 8(d) rule is the firmest estimate that the Agency can utilize. However, EPA has now attempted to estimate costs forthose companies that handle thelisted substances, buthave

no studies to report. TheAgency did this by searching the TSCA Inventory to determine thenumber ofcompanies that reported the listed substances and then multiplying this number by a factor of three to account forprocessors and distributors.

Although some commenters indicated that the scope of therule extends beyond the "chemical industry" and woudl therefore increase thepotential number ofprocessors ofthe listed substances beyond ourestimate, EPA believes that its estimates or respondents is proper for thefollowing

reasons. First,over 85 percent ofthe companies thatreported forthe first section 8(d) rule were concentrated in the chemical, allied products, and petroleum refining industries. Second, most ofthe comments received from companies on the proposed rule were from companies in those industries,. which EPA believes is an indicator of the respondent population forthe final rule. Third, EPA believes that almost all ofthe studies performed on the listed substances are initiated by the manufacturers and primary processors ofthe substances, which is the reason EPA exempted distributors from reporting. These companies are heavily concentrated in the chemical, alliedproducts, and petroleum refining industries.

Furthermore, the changes, exemptions, and limited file search prescribed in this rule should eliminate the possibility ofa substantial burden ofunavailing searches.

(8) The analysis accompanying the proposal did not consider the ongoing
cost ofreviewing newly completed studies during the multiyear follow-up period.

EPA does not believe that consideration ofongoing studies poses a substantial burden that would appreciably alter the report's impact analysis. Since firms would review newly completed studies for their effects regardless ofthis rule, no file retrieval
costs associated with other health and safety studies would be incurred for these new ones.

(9) Comments criticized continued reliance on the assumption that 2.6 firms will respond per chemical, which was based on EPA's experience with the first section 8(d) rule, even though the additional chemicals subject to the rule

are qualitatively different (high volume, extremely prevalent) than the chemicals subject to 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 toboth rules are high volume and extremely prevalent. Further,approximately 6.2 firms reported for the Inventory on chemicals that were listed on the first section 8(d) rule (this figure represents the average number offirms or companies, not the
average number ofsites], whereas only 2.6 firms responded per chemical for the original section 8(d) rule. For the subsequent ITC-recommended chemicals on the proposed rule, 1.1 firms reported for the Inventory. An average of2.2 firms reported for the Inventory on chemicals selected by the EPA on the proposed rule. This indicated that the Agency's reliance on the 2.6 figure would actually tend to overstate the Federal Register / Vol. 47,38790 Federal Register 

## /Vol. 47, No. 171 

## I Thursday, September 2, 1982 

## I Rules and Regulations number of expected respondents for the present rule. (10)Comments were also concerned about the categories ofchemicals in the rule. They specifically asked forbetter definitions ofthe categories orfor lists ofthe chemical in the categories for which EPA wants studies. Because of chemical nomenclature complexities, the commenters suggested that the burden ofdeciding whether a given chemical should be counted in or out could be great.

EPA has eliminated one ofthe more troublesome categories fromthe listacrylic acid and methylacrylic acid and their esters. In addition, the Agency has given better descriptions and more examples to define the categories. EPA believes that these steps, plus the fact that the categories now on the rule are
ones that companies have become familiar with in following ITC recommendations for testing, should reduce the cited burden. A company that has a question about whether a

- particular chemical is included in a category should call theinformation number given at the beginning ofthis notice. EPA staffwillbe available to return these calls and answer questions.

The basic elements EPAhas included in the final Reports Impact Analysis are:

(a) Corporate rule review-2 hours at $50perhour.

(b)Corporate identification of pertinent files--3 hours at $50 per hour.

(c) File search at plant site--6 hours at $30 per hour.

(d)Listing study titles-1hour at $15 perhour.

(e) Photocopying per study-%K hour at $15 perhour.

(f)Final review before submission-1 hour at$50 perhour.

EPA's estimate oftotal cost of therule

uses the above figures and assumes that 891 firms willperform an initial review; 447 firms will submit 3,784 reports of 50 pages each; and each firmhas, on a weighted average, 1.5 plant sites.

The corporate rule review step was suggested by commenters, as wasthe corporate identification oflocations to be searched. EPA has increased the hourly costs ofmanagerial review and file searches by $10 each fromprevious estimates, and increased thefile search -timeper site from four to six hours. These new estimates are based upon suggestions from commenters and the changes EPA has made to rule requirements. One caveat that must be kept in mind is that these are average costs. Individual firms may experience greater or lessercosts depending on their size.

EPA received comment that one hour for finalreview before submission would notbe enough to accommodate decisions on confidentiality. The Agency's estimate ofan average of one hourreview per study is reasonable. EPA does not expect that a company should have to scrutinize a study for confidential information just before it is submitted to EPA. Confidential information in a study should already havebeen identified as such bythe company. For example, to get a court to prevent disclosure ofconfidential information, a company must be able to show that the information was given special treatment by the company,i.e., marked confidential, orkept in limited

access files. Therefore, theAgency believes that most ofthe information in

a study that is confidential willhave been previously identified as such by the company, and it should notbe necessary to check with virtually every department ofthe company, as some commenters suggested, to check whether each data element is confidential.
IX. Public Record

EPA has established a public record (docket number OPTS-84003A) for this rulemaking document, which along with

a complete indexis available for inspection in the OPTS Reading Room, Ran. E-107, 401M'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 thisrule. Following is a listofthe documents which constitute the record for this rulemaking. Public comments on the proposed rule are ndt individually listed, butwill be available upon request in the OPTSreading room. EPArequests that it be notified ofany additions or deletions to this record within the next 30 days.

(1) Health and Safety StudyReporting Regulations, July 18,1978, Public Record, Docket No.084001.

(2] Manufacturing Chemists AssociationPetition under section 21 ofTSCA, September 12, 1978.

(3)Denial ofCitizens' Petition, 43 FR 56724- 56727.

(4)The entire docket inDow Chemical Companyv. UnitedStatesEnvironmental Protection Agency, eto. DocketNo. 78-2203 (3rdCir.).

(5] Revocation ofRule, 44 FR 6099. (6)Reports Impact Analysis ofthis rulemaking.

(7)All comments on this rule, including any comments received from the Office of Management and Budget during Paperwork Reduction Act review.

(8) General Comments on the Proposed Section 8(d)Rule.

(9)All relevant support documents and studies. (10) Records ofall communications between EPApersonnel and persons outside the Agency pertaining to the development of this rule. (Thisdoes not include anyinter-or Intra-agency memoranda unless specifically noted inthe index ofthe 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 Assessmeht 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 majorbecause it does not have an effect of$100 million or more on the economy. It is expected to have a one-time cost of about $725 thousand. It does not have a significant effect on competition, or costs orprices.

This regulation was submitted to the Office ofManagement and Budget for review as required by Executive Order 12291.
RegulatoryFlexibility Act

Since this rulewas proposed before the effective date of the Regulatory Flexibility Act, 5U.S.C. 601 et seq., the Act's requirements do not apply.. However, based on theAgency's experience with a previous section 8(d) rule, it expects that only about 1percent ofthe respondents will have gross sales ofless than 20 million dollars.
Paperwork ReductionAct

Information collection requirements contained in this regulation (§§ 716.6 and 716.7) have been approved by the Office ofManagement and Budget (OMB) under the provisions ofthe Paperwork Reduction Act of1980 U.S.C. 3501 etseq.and have been assigned OMB Control Number 2070-0004.

This rule requires manufacturers and processors of40 chemicals and categories ofchemicals 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 forpurposes 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 ofTSCA.

Lists ofSubjects in 40 CFR Part716

Chemicals, Health and safety, Environmental protection, Hazardous materials, Recordkeeping and reporting. 38790 Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations

### Federal Register 

## I Vol. 47, No. 171 

## /Thursday, September 2, 1982 

## I Rules and Regulations 38791

Dated: August 19, 1982. John E.Daniel, ActingAdministrotor.

Therefore, Chapter I ofTitle 40 of the Code ofFederal Regulations is amended by adding a new part 716 consisting at this time ofSubpart 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 ofsubpart requirements. 716.6 Submission ofcopies ofstudies. 716.7 Submission oflists ofstudies. 716.8 EPArequests for submission offurther information. 716.9 Howto report on substances and mi,;tures. 716.10 Reporting physical and chemical properties. 716.11 Exemptions to reporting requirements. 716.12 File search. 716.14 Reporting schedule. 716.16 Confidentiality claims. 716.17 Substances and designated mixtures to which this subpart applies. 716.18 Additions to listsofsubstances and designated mixtures to whichthis subpart applies. 716.19 Sunset provision.

Authority: Sec. 8(d), Pub.L 94-469, Stat. 2029 (15U.S.C. 2607(c)).
Subpart A-General Provisions §716.1 Scopeand compliance.

(a)This Subpart sets forth requirements for the submission of lists and copies ofhealth and safety studies

on chemical substances and mixtures selected for priority consideration for testing rules under section 4(a) ofthe Toxic Substances Control Act (TSCA) and on other chemical substances and mixtures for whichEPA requires health and safety information in fulfilling the
purposes ofTSCA.

(b)Section 15(3) ofTSCA makes it unlawful for any person to fail orrefuse
to submit information required under this Subpart. Section 16 provides that a violation ofsection 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 ofTSCA apply to this Subpart. In addition, the following definitions are provided for the purposes of this Subpart: (a) "Byproduct" means a chemical substance produced without a separate commercial intent during the manufacture, processing, use, or disposal of another chemical substance(s) or mixture(s).

(b) "Co-product" means a chemical substance produced for a commercial purpose during the manufacture, processing, use, or disposal ofanother chemical substance(s) or mixture(s).

(c) "Copy ofstudy" means the written presentation of thepurpose and methodology ofa study and its results. (d) "EPA" means the United States Environmental Protection Agency.

(e)"Health and safety study" or "study"means any study ofany effect of a chemical substance or mixture on health or the environment or onboth, including underlyingdata and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, toxicological, clinical, and ecological or other studies of a chemical substance ormixture, and any test performed under TSCA.

(1)Itis intended that the term "health and safety study" be interpreted -broadly.Not only is information which arises as a result of a formal, disciplined studyincluded, but other information relating to the effects ofa chemical substance or mixture on health orthe environment is also included.Any data that bear on the effects ofa chemical substance on health or the environment would be included. Chemical identity is part of,or underlying data,to, a health and safety study.

(2)Examples are: (i)Long- and short-term tests of mutagenicity, carcinogenicity, or teratogenicity; data on behavioral disorders; dermatoxicity, pharmacological effects; mammalian absorption, distribution, metabolism, and excretion; cumulative, additive, and synergistic effects; and acute, subchronic, and chronic effects.

(ii)Tests forecological orother environmental effects on invertebrates, fish, or other animals, and plants, including: acute toxicity tests, chronic toxicity tests, critical life stage tests, behavioral tests, algal growth tests, seed germination tests, plant growth or damage tests, microbial function tests, bioconcentration orbioaccumulation tests, and model ecosystem (microcosm) studies.

(iii) Assessments ofhuman and environmental exposure, including workplace exposure, and impacts ofa particular chemical substance or mixture on the environment, including surveys, tests and studies of: Biological, photochemical, and chemical degradation; structure/activity relationships; air,water, and soil transport; biomagnification and bioconcentration; and chemical and physical properties, e.g.,boiling point, vaporpressure, evaporation rates from soil and water, octanol/water partition coefficient, and water solubility.

(iv)Monitoring data, when theyhave been aggregated and analyzed to

measure the exposure ofhumans orthe environment to a chemical substance or mixture.

(f) "Importer" means any person who imports a chemical substance, including

a chemical substance as apart of a mixture orarticle, into the customs territory ofthe United States and includes the person primarily liable for thepayment of any duties on the merchandise or an authorized agent acting onhis behalfJas defined in 19 CFR 1.11). Importer also includes, as appropriate:

(1)The consignee. (2) The importer ofrecord. (3)The actual owner,if an actual owner's declaration and superseding bondhas beenfiled in accordance with 19 CFR 141.20.

(4] The transferee, iftheright to draw merchandise in a bonded warehouse has been tranferred in accordance with Subpart C of19 CFRPart 144. For the purpose ofthis definition, the customs territory oftheUnited States consists ofthe 50 States, Puerto Rico, and the Districtof Columbia.

(g)"Impurity" means a chemical substance which is unintentionally present with another chemical substance.

(h) "Manufacture" and "Process"

mean manufacture orprocess for commercial purposes.

(i)"Manufacture forcommercial purposes" means:

(1)To import,produce, or manufacture with thepurpose ofobtaining an immediate or eventual commercial advantage forthe manufacturer, and includes, among other things, such "manufacture" ofany amount of a chemical substance or mixture:

(i)For commercial distribution, including fortest marketing.

(ii)Foruse by themanufacturer, including use forproduct research and development, oras an intermediate.

(2) The term applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal ofanother substance or mixture, including bothbyproducts and coproducts that are separated from that other substance or mixture and impurities that remain in that substance

ormixture. Byproducts and impurities may notin themselves have commercial Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations 3879138792 Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations

value. They are nonetheless produced for the purpose ofobtaining a commercial advantage since they are part ofthe manufacture ofa chemical product for a commercial purpose.

UI) "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 ofthe Federal government.

(k) "Process for commercial purposes"

means thepreparation ofa chemical substance ormixture, after its manufacture, for distribution in

commerce with thepurpose ofobtaining

an immediate or eventual commercial advantage for the processor. Processing of any amount ofa chemical substance

ormixture is included. If a chemical substance ormixture containing impurities is processed for commercial purposes, then those impurities are also processed for commercial purposes.

(1)"Propose to manufacture, process,
or distribute" means that a person has made a management decision to commit financial resources toward the manufacture, processing, or distribution of a chemical substance or mixture.

(in] "Substance" means "chemical substance" as defined at section 3(2)(A) ofTSCA, 15 U.S.C. 2602(2)(A). (n) 'TSCA" means theToxic Substances Control Act 15 U.S.C. 2601 et. seq. §7164 Overview of subpart requirements.

This section highlights basic requirements. For additional procedures and qualifications, refer to pertinent, individual sections.

(a)Adequate filesearch for compliancewith thissubpart. Persons

are not required to search any records retired prior to December 31,1979for 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 therequired information and to records kept byindividual employees whose assigned duty is to advise the company ofthe health and environmental effects ofchemicals under §716.12.

(b)Personswho mustreport.(1)A person who manufactures or processes a substance or designated mixture listed in §716.17 at the timeit is listed, or proposes to do so,must do the following for that substance or designated mixture-(i) Submit copies ofall nonexempted studies in his possession at the time he becomes subject to the rule under §716.6. Under §716.14 the copies mustbe 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 listmust be submitted within 60 days after the addition ofthe substance or designated mixture to §716.17 and copies ofsuch studies must be submitted within 30 days oftheir completion under §716.14.

(iii) Inform EPA within 30 days ofany study initiated by or forhim after the initial 60 day reporting period and submit a copy ofthe study when it is completed. This requirement continues until the sunset date specified in §716.19; it applies not only to persons who manufacture orprocess 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 ofwhen it is added to §716.17.

(c)Studies tobe reported. In general, studies, as defined at §716.3(d), that are unpublished are reportable, i.e., mustbe submitted or listed, for any substance or designated mixture listed in §716.17. However, this requirement has limitations according to the nature ofthe 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 mustbe submitted.

(2) Studies ofmixtures known to contain substances or designated mixtures listed in § 716.17 are reportable except for studies ofphysical and chemical properties and the studies exempted at §716.11(f) (1) through (6).

(3)Studies ofsubstances or designated mixtures that a person who is reporting has manufactured or " processed or proposed to manufacture

orprocess only as impurities are not generally reportable under §716.11(i).

(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 daily monitoring records

are not reportable except by special request under §716.8. 

### §716.6 Submission ofcopies of-studles. (a)(1) Except as provided in §§ 716.10 and 716.11, persons must send to EPA copies ofany 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 orprocess (including as known byproducts) within theten years preceding the effective date forreporting

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

orhealth 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 §716.8.

(b) Submissions under paragraph (a) ofthis 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 submitting official, and the name and address ofthe manufacturing or processing establishment on whose behalfthe 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 20852. §716.7 Submission of listsofstudies.

(a) Except as provided in §§716.10 and 716.11, persons must send the lists described in paragraphs (a) (1) and (2) of this section to EPA for each ofthe substances or designated mixtures listed in §716.17 which they manufacture or process orpropose tomanufacture or process (including as known byproducts).

(1)A list of ongoing health and safety studies being conducted for orinitiated by them, noting foreach entry the purpose ofthe study, type ofdata collected, and progress and anticipated date ofcompletion. This requirement continues until the sunset date specified by §716.19. Studies initiated after the initial 60 day reporting period mustbe listed ifthey included one or more ofthe following tests: chronic tests; long- and short-term tests or mutagenicity, carcinogenicity orteratogenicity; andFederal Register 

## I Vol. 47, No. 171 

## I Thursday, Septembei' 2, 1982 

## I Rules and Regulations 38793

the biological and environmental fate tests listed in §716.10 (h)through 

### (j).

(2) A list ofunpublished studies known to them ofwhich theydo not have copies. The name and address of any personknown to them to possess a copy oftheunpublished studymust accompany each entry on the list.For purposes ofthis section only, an unpublished study willbe considered to be "known to" a person, ifthe study can be discovered by a file search in accordance with §716.12.

(b)Submissions under paragraph (a) ofthis sectionmust be indexed by chemical, including CAS number if known, and mustbe accompanied by a
cover lettercontaining the name,job title, address and telephone number of the submitting official, and the name and address ofthe manufacturing or processing establishment on whose behalfthe submission is made. (c)The list ofhealth and safety studies should be submitted,preferably by certified mail, to: U.S. Environmental Protection Agency, TSCA-8D1, P.O. Box 2060, Rockville, Maryland 20852.
§716.8 EPA requestsfor submissionof furtherinformation.

EPA mayrequest the following submissions after the initialreporting under §§716.6 and 716.7. Ifthe requested submissions are not made, EPA may subpoena them under section 11 ofTSCA, 15U.S.C. 2610.

(a)Submission ofunderlying data of the kind described in §716.6(a)(2) by persons who submit copies of studies under §716.6 orlist studies under §716.7(a)(1).

(b)Submission ofpreliminary reports ofongoing studies by persons who list the studies under §716.7(a)(1).

(c) Submission ofcopies ofstudies by persons listed under §716.7(a)(2) as possessing them.
§716.9 How to report on substancesand mixtures.

Section 716.17 contains two lists, one of substances and one ofdesignated mixtures. Studies oflisted substances and designated mixtures shall be reported as follows:

(a) When a substance is individually listed under §716.17(a), studies-ofthe substance and studies ofmixtures known to contain the substance must be reported as studies ofthat substance.

(b)When two or more substances are listedas a designated mixture under §716.17(b), studies ofthe designated mixture and studies of any mixture known to contain the designated mixture must be reported as studies of the designated mixture. (c) Studies ofthe following preparations of a substance must be reported as studies ofthe substance itself, not as studies ofmixtures known
to contain the substance.

(1)The substance in aqueous solution. (2) The substance containing a small amount ofan additive, such as a stabilizer,emulsifier, orother chemical added forpurposes ofmaintaining the integrity orphysical form ofthe substance.

(3) The substance at any grade of purity.

§716.10 Reporting physical and chemical properties.

Studies ofphysical and chemical properties must be reported under this subpart ifperformed forthe purpose of determining the environmental or biological fate ofa substance, and only ifthey investigated one or more of the following properties:

(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.

(j)Degradation by biological mechanisms-aerobic and anaerobic.
§716.11 Exemptions to reporting requirements.

The following are exempt fromthe
copy and list submission requiremente of §§ 716.6 and 716.7.

(a) Studies which have been published in the scientific literature.

(b) Studies previously submitted to EPA, e.g., studies voluntarily submitted during section 4 proceedings orunder the previous section 8(d) rule.

(c) Studies previously submitted to any Federal agency with no claims of confidentiality.

(d) Studies conducted or initiated by

or for another person who is subject to §§ 716.6 and 716.7.

(e) Studies ofchemical substances which are not on the TSCA Chemical Substance Inventory, e.g., research and development studies on new chemical substances.

(f) The following types ofstudies when the subject ofthe study is a mixture known to contain a substance

or designated mixture listed in § 716.17. (1)Acute oral toxicity studies. (2) Acute dermal toxicity studies. (3) Acute inhalation toxicity studies. (4)Primary eye irritation studies. (5) Primary dermal irritation studies. (6)Dermal sensitization studies. (7) Physical and chemical properties.
Ifthe substance or designated mixture is

an impurity, no reporting is required (see § 716.11(i), below).

(g) Analyzed aggregations of monitoring data based on monittring data acquired more than five years preceding the date the substance or designated mixture was added to the list in § 716.17.

(h)Analyzed aggregations of monitoring data on mixtures known to contain one ormore substance or designated mixtures listed in § 716.17, when the monitoring data are not analyzed to determine the exposure or concentration levels ofthe substances

or designated mixture listed in § 716.17.

(i) Studies on a substance or designated mixture listed in § 716.17 that the person who is reporting has manufactured orprocessed orproposed
to manufacture orprocess 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.

Persons will satisfy the requirements ofthis Subpart ifthey limit their search forthe required information to records in which such information is expected to be found in the ordinary course oftheir business, and to information kept by employees whose assigned duty is to advise the company on the health or environmental effects ofchemicals. For
purposes ofthis rule, persons do not have to search files retired prior to December 31, 1979. §716.14 Reporting schedule.

(a)Except as provided inparagraphs (b) and (c) of this section, submissions under §§ 716.6 and 716.7 must be postmarked on orbefore 60 days after the effective date ofthe listing ofa substance or designated mixture in §716.17 orwithin 60 days of proposing
to manufacture orprocess a substance

or designated mixture iffirst done after the effective date of the substance's or designated mixture's listing in § 716.17.

(b)Persons subject to the listing requirement of§ 716.7 must inform EPA of any study initiated by orfor them within the three-year reporting period described in § 716.19 within 30 days of initiation ofthe study. Copies ofstudies listed as ongoing under § 716.7(a)(1), or studies initiated withinthe reporting Federal Register I Vol. 47, No. 171 / Thursday, Septeinbei 2, 1982 / Rules and Regulations 3879338794 Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations

period, must be submitted within 30 days oftheir completion.

(c) Respondents who cannot meet a deadline under this section may apply for a reasonable extension oftime. Requests for extensions should be addressed to: Document Control Officer, Office ofPesticides 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)Anyperson submitting a document under this Subpart may assert a business confidentiality claim covering all orpart ofthe submitted material. Any information covered by a claim will be disclosed byEPA only as provided in procedures setforth at Part 2 ofthis title.

(b)Ifno claim accompanies a document at the timeit is submitted to EPA, the document will be placed in an open file available to thepublic without further notice to the respondent.

(c)(1) Section 14(b) ofTSCA states that EPA may notwithhold from disclosure, on the grounds that they are confidential business information, health and safety studies ofany substance that has been offered for commercial distribution or forwhich testing is required under TSCA section 4

orfor which noticeis required under TSCA section 5, except to the extent that disclosure ofdata from such studies would reveal: (i)processes used in the manufacturing or processing ofa substance ormixture, or (ii)the portion ofa mixture comprised by any ofthe substances in the mixture.

(2) Any respondent who wishes to assert a claim thatpart of a study shouldbe withheld from disclosure because disclosure would reveal a confidential process or quantitative mixture composition orother 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 thematerial subject to the claim. Information in a study, such as company name or address, financial statistics, orproduct codes used by a company, which is irrelevant to any health orenvironmental effect of a chemical, may be claimed confidential and not subject to the disclosure requirements ofsection 14(b) ofTSCA. Other information contained in a study, the disclosure ofwhich would clearly be

an unwarranted invasion ofpersonal 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 ofconfidentiality for data contained in a submitted document, therespondent must submit two copies of the document. (1) One copy must be complete. In that copy, the respondent must indicate what data, ifany, 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 thebasis ofthe claim.

(2) If some data are claimed as confidential, the respondent must submit a second copy. The second copy mustbe complete, except that all information claimed as confidential in the first copy must be deleted.

(3)The first copy willbe for internal

use by EPA. The second copy willbe placed in an openfile to be available to the public.

(4) Failure to furnish a second copy when information is claimed as confidential in the first copy willbe considered a presumptive waiver ofthe claim ofconfidentiality. EPA will notify the respondent by certified mail that a finding ofa presumptive waiver ofthe claim ofconfidentiality has been made. The respondent will be given 30 days from the date ofreceipt ofnotification to submit the required second copy. Ifthe 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 whichthissubpart applies.

(a)(1) Substances. The following substances are subject to this subpart as of October 4, 1982.



### Substances CAS Numbers 

### (examples for groups)

Acetonitrile. Acrylamide. Alkyl epoxides -- including 

### all noncyclic aliphatic hydrocarbons with one or.
more epoxy functional groups.

R= 

### H or alkyl
R= 

### H or alkyl R2 

### =f H or alkyl

R

3 

### = H or alkyl R4 

### = H or alkyl
Groups R1 

### -R4 

### may contain one or 

### more epoxide functions

BILLING CODE 6560-50-M 

### 75-05-8 79-06-1 75-21-8 75-56-9 106-88-7 

### 1464-53-5Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations



### CAS Numbers Substances (examples for groups)

Alkyl phthalates -- all alkyl esters 

### of 1,2-benzene dicarboxylic acid (orthophthalic acid). 

# 0 II

R= alkyl R

2 

### alkyl



### Aniline and chloro-, bromo-, and/or nitio-anilines.

Antimony.

Antimony trioxide.

Antimony sulfide. 84-61-7 84-66-2 

### 84-74-2 117-81-7 117-84-0 

### 119-06-2 119-07-3 131-11-3 26761-40-0 

### 27554-26-3

62-53-3 108-42-9 88-74-4 121-87-9 89-63-4 141-85-5 95-51-2 147-82-0 95-76-1 554-00-7 95-82-9 608-27-5 97-02-9 626-43-7 99-09-2 634-93-5 99-29-6 635-22-3 99-30-9 827-94-1 100-01-6 1817-73-8 106-40-1 5388-62-5 106-47-8 6283-25-6 3531-19-9



### 7440-36-0

1309-64-4

1345-04-6

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= PI"OR 2 

# "OR3 78-30-8 

### 78-32-0 78-33-1 115-86-6 563-04-2 1241-94-7 

### 1330-78-5 2528-36-1 25155-23-1 26444-49-5 28108-99-8 29761-21-5 51363-64-5 56803-37-3 38795

### 38796 Federal Register / Vol. 47, No. 171 

## / Thursday, September 2, 1982 / Rules and Regulations



### CAS Numbers (examples for groups) Substances

R1 

### = 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

R

3 

### alkyl; or phenyl, either unsubstituted or substituted with one or more alkyl or aralkyl groups

Asbestos

- Asbestiform varieties of: 

### chrysotile (serpentine); crocidolite (riebeckite); amosite (cummingtonitegrunerite); anthophyllite; tremolite; and actinolite.

Bisazobiphenyl dyes derived from benzidine and its congeners, orthotolidine (dimethylbenzidine) and dianisidine (dimethoxybenzidine). 1332-21-4 12001-29-5 12172-73-5 17068-78-9

72-57-1 91-92-9 91-96-3 573-58-0 992-59-6 1937-37-7 2150-54-1 2429-71-2 2429-73-4 

### 2429-74-5 2429-79-0 2429-81-4 2429-82-5 2429-83-6 

### 2429-84-7 2586-57-4 2586-58-5

Chlorinated benzenes,

mono- and di-.

Chlorinated benzenes, tri-, tetra- and penta-. 2602-46-2 2610-05-1 2893-80-3 3530-19-6 3567-65-5 3626-28-6 4335-09-5 

### 6358-29-8 6360-54-9 

### 6449-35-0 6637-88-3 

### 6656-03-7 6739-62-4 

### 8014-91-3 10401-50-0 16071-86-6 16143-79-6 20282-70-6

95-50-1 106-46-7 108-90-7 541-73-1

87-61-6 95-94-3 108-70-3 120-82-1 608-93-5 634-66-2 634-90-2Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations



### CAS Numbers Substances (examples for groups)

Chlorinated naphthalenes

-- 

### chlorinated derivatives of naphthalene (empirical formula CIOHxCly where x+y=8).

Chlorinated paraffins

-- 

### chlorinated paraffin oils and chlorinated paraffin waxes, with chlorine content of 35 percent through 70 percent by weight.

Chloromethane (methyl chloride).

Cresols -- ortho, meta-, and 

### para-cresol.

Cyclohexanone.

Dichloromethane. (methylene chloride)

1,2-Dichloropropane. 90-13-1 1321-64-8 1321-65-9

61788-76-9 63449-39-8 68920-70-7

74-87-3

95-48-7 106-44-5 108-39-4

108-94-1

75-09-2



### 78-87-5

Glycidol and its derivatives.



# H 2

# 0-R

R = H; alkyl, alkenyl or 

### alkynyl; aryl; acyl

Where R = alkyl, alkenyl, alkynyl, aryl, or acyl; any substituentso

or functional groups may be present with the alkyl, etc., groups. 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-U7-5 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 38797

### 38798 Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations

Substances

Halogenated alkyl epoxides

-- halogenated noncyclic aliphatic 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,' R3

RI - X or CnH2n+lyXy (y=l to 2n+l)

R2 = H or X or CnH2n+lyXy (y=0 to 2n+i)

R3 = H or X or CnH2n+lyXy (y=0 to 2n+l)

R4 = H or X or CnH2n+l.yXy (y-0 to 2n+l)

X

- halogen

Groups R1 - 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. 87-68-3

77-47-4

123-31-9

78-59-1

141-79-7

101-77-9

78-93-3

108-10-1

98-95-3

106-50-3

11126-42-4 12642-23-8 61788-33-8

110-86-1

106-51-4

108-88-3

71-55-6

75-02-5

75-38-7

95-47-6 106-42-3 108-38-3

[Reserved]

tReservedl

BILLNG CODE 6560-6-CFederal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations 38799

§716.18 Additionsto Hats ofsubstances and designated mixtures to whichthis 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 (b) ofthis section, substances and designated mixtures will be added after publication in the Federal Register ofa notice ofproposed amendment of this subpart.There will be a 30-day public
comment period on the notice; after consideration ofthe comments, a final amendment will identify the substances and mixtures added. (b)Substances and designated mixtures that have beenrecommended for testingby the Interagency Testing Committee, established under section 4 ofTSCA, willbecome subject to this subpart 30 days after publication ofa notice to that effect in the Federal Register.



### §716.19 Sunset provision.

The reporting period on a substance

ordesignated mixture will terminate no later than three years after that substance or designated mixture is added to the list in § 716.17. The automatic termination date forthe three
year reporting period on a substance or mixture willbe the.annual sunset date (May 1orNovember 1)that falls no later than three years after reporting begins,
e.g., a reporting requirement taking effect on January 1, 1982 would expire notlaterthan November 1,1984. A notice willbe published in the Federal Register announcing the termination date forreporting forthe 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 andToxic Substances.

[FRDo. 82-24058 Filed9-1-82; 8.45 am)

BAJNG CODE 6660-50-M