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 Lists and Copies of

Health and Safety Studies

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule requires the

submission of unpublished health and

safety studies on specifically listed

chemicals by chemical manufacturers,

processors, and others in possession of

such studies. The rule is issued under

section 8(d) of the Toxic Substances

Control Act (TSCA], 15 U.S.C. 2607(d).

The Administrator will issue

amendments in the Federal Register to

add to the list of chemicals subject to

the rule. Amendments to add chemicals

recommended for testing by the

Interagency Testing Committee (ITC),

established under section 4 of TSCA,

will be effective upon publication.

Amendments to add other chemicals

will be subject to a thirty-day comment

period. This notice promulgates the final

version of regulations proposed on

December 31, 1979 at 44 FR 77470.

EFFECTIVE DATE: October 4, 1982. -

FOR FURTHER INFORMATION CONTACT:

Douglas Bannerman, Acting Director,

Industry Assistance Office (TS-799),

Office of Toxic Substances,

Environmental Protection Agency, Rm.

E-511, 401 M Street, SW., Washington,

DC 20460; toll free (800-424-9065); in

Washington, DC (554-1404]; outside the

USA (Operator-202-554-1404).

SUPPLEMENTARY INFORMATION: OMB

Control Number: 2070-0004.

Background

In the Federal Register of July 18, 1978

(43 FR 30984), EPA promulgated a previous version of this rule under

section 8(d) of TSCA (43 FR 30984)

requiring reporting of studies of

chemicals listed on the first ITC report.

That rule was challenged by the Dow

Chemical Company and was

subsequently revoked (see 44 FR 77470).

Two provisions of that rule were the

subject of a lawsuit, Dow Chemical

Company v. EPA, 605 F.2d 673 (1979).

The two provisions concerned obtaining

studies on chemicals manufactured or

processed for research and development

purposes and obtaining copies of studies

on a chemical from companies that do

not manufacture, process or distribute

that chemical. The Court upheld EPA's

authority for both provisions.

Purpose and Use of the Rule

Under this rule, EPA will acquire

unpublished health and safety studies

on specified chemicals from

manufacturers and processors of the

chemicals. The Agency will use the

studies to support its investigations of

the risks posed by chemicals and, in

particular, to support its decisions

whether to require industry to test

chemicals under section 4 of TSCA. The

addition of chemicals to the rule will

occur by notice of amendment in the

Federal Register. In the case of

chemicals recommended for testing by

the ITC, the amendment will be effective

thirty days after publication. For other

chemicals, the amendment will be

subject to a thirty-day public comment

period before promulgation.

Studies of health and environmental

effects, including studies of exposures of

people or the environment, are the

fundamental ingredients of any

assessment of chemical risk. For this

reason, EPA will require reporting under

this rule for specific chemicals that are

under investigation either in early stages

of risk assessment or when action to

control exposure is being considered.

Furthermore, EPA expects to require

submission of unpublished health and

safety studies for all chemicals under

consideration for required testing under

sbction 4 of TSCA. EPA will evaluate

the studies reported under this rule

together with other available data to

construct a picture of the effects of

chemicals and their associated risks.

The studies submitted under the

previously issued section 8(d) rule (43

FR 30984, July 18, 1978], have been very

useful in the Agency's investigation of

the effects of the ITC-recommended

chemicals covered by that rule. The

studies have been used in designing

appropriate tests, and in support of the -

basic decision whether testing for a

particular biological effect should be

carried out. For example, studies

submitted on chlorinated benzenes

contributed significantly to EPA's design

of a testing scheme for mutagenicity.

The Agency, itself, will conduct these

tests. Similarly, studies submitted on

monochlorobenzene supported our

decisions on the need for testing of the

reproductive effects of that substance.

These are examples of two important

contributions that submitted studies can

make to testing decisions. ,

Overview of Rule Requirements

Extensive comment was received on

the question of what records a company

should search to comply with this rule.

The proposal spoke of information

"known to" or in the "possession" of

respondents. The definitions given for

these terms were broad, and comments

indicated that, under these definitions,

companies would feel obliged to search

many more records than we believe

necessary. We have decided to replace

the definitions with a description of the

scope of a search that will be adequate

for this rule. The rule now says that

respondents are responsible for

searching only the company files in'

which they ordinarily keep studies and

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 of copies of studies in the

possession of persons subject to the rule

and submission of lists of studies

ongoing at the time of submission or

known to but not possessed by the

submitter. Persons who are

manufacturing or processing a chemical

at the time it is listed in the rule, or are

proposing to do so, are required to

submit both copies and lists of studies

for that chemcial. EPA decided to

exempt distributors from reporting,

because we believe that very few

distributors perform these studies and

that the burden to these persons

outweighs making them subject to the

rule. An examination of the respondents

to the previous section 8(d) rule

revealed that no distributors submitted

studies. These reporting requirements

remain applicable until the sunset date

for the chemical (three years after the

chemical is made subject to the rule) to

cover studies begun during that period,

and to cover persons who begin, or are

proposing to begin, manufacturing or

processing a listed chemical during that

period.

Persons who are not involved with a

chemical when it is listed but

manufactured or processed it or

proposed to do so any time during the

ten years prior to the time it is listed, are

required to submit copies of studies for

that chemical, but are not required to list

studies.

Since the proposal, changes have been

made regarding the types of studies that

must be submitted. Several types have

been exempted. The final requirements

represent the Agency's effort to reduce

the burden of the rule while still

obtaining the most useful studies for our

assessments. EPA received many good

comments that allowed the Agency to
No. 171 / Thursday, September 2, 1982 / Rules and Regulations 38781

identify the studies that were most

burdensome to submit and least useful

for its assessments. Therefore, the

Agency has added to the exemptions

originally proposed. The final rule has

the following overall exemptions: (1)

Physical and chemical properties other

than ten that are specifically listed; (2)

studies of a substance or mixture that a

person has manufactured or processed,

or proposed to manufacture or process

as an impurity; (3) published studies; (4)

non-confidential studies submitted

previously to another Federal agency;

(5) all studies previously submitted to

EPA (this includes studies voluntarily

submitted during section 4 proceedings

or under the previous section 8(d) rule);

(6) studies of chemical 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 (unless the EPA requests

the data later, by personal letter). In

addition, certain types of studies of

mixtures are exempted as stated below.

In summary, the reportable studies

are: (1) Studies of listed chemicals with

the seven exclusions noted above; and

(2] studies of mixtures containing listed

chemicals with the seven exclusions

noted above and also excluding: acute

oral toxicity studies, acute dermal

toxicity studies, acute inhalation

toxicity studies, primary eyeirritation

studies, primary dermal irritation

studies, and physical and chemioal

properties.

Organization of This Preamble

EPA received more than 100

responses to the proposed rule, each

containing multiple comments. Several

aspects of the rule received numerous

comments; other aspects, only one or a

few. In this preamble, the Agency

discusses the major comment areas:

specific definitions; chemical substances

subject to the rule; lists and copies to be

submitted and who should submit them;

studies not subject to mandatory

reporting; file search; reporting schedule

and sunset provision; confidentiality;

and economic impact. The subjects that

received only one or a few comments

are individually discussed in a

document entitled "General Comments

on the Proposed Section 8(d) Rule"

which is part of the public record.

1. Specific Definitions

A. Manufacture and Process for

Commercial Purposes

EPA interprets the term "manufacture

or process for commercial purposes" to

refer to such activities conducted, in

whole or in part, for the purpose of

obtaining a commercial advantage for

the manufacturer or processor as

distinguished from charitable or

academic purposes. Therefore,

chemicals manufactured for product

research and development (R & D), as

well as byproducts and impurities of

commercial manufacturing and

processing, are "for commercial

purposes."

EPA received comments saying that

the Agency's interpretation is wrong

because these substances themselves

are not actually marketed, and, in the

case of byproducts and impurities, are

not desired for the market. However, the

Agency considers it undeniable that

products of commercial endeavors are

made for commercial purposes.

Moreover, the reason that section 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 "for commercial

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 the potential reach

of this interpretation. A description of

the applicability of the rule to impurities,

byproducts, and R & D chemicals

follows.

(1) Impurities. Under this rule, EPA

has excluded from reporting any studies

of chemicals that the person reporting

has manufactured or processed or has

proposed to manufacture or process

only as impurities.

Since the chemicals presently listed in

the rule are marketed most widely as

desirable products, rather than as

impurities, EPA expects that the

excluded studies will be so few as not to

justify the burden of searching for them.

However, in other circumstances, the

Agency may propose to require the

excluded studies to be reported for some

chemicals.

(2) Byproducts. It should be noted that

the definition of "manufacture for

commercial purposes" includes only

byproduct substances and mixtures-that

are separated from the other substance

or mixture that is being manufactured,

processed, used, or disposed of. Other

substances that are produced as

byproducts, but not separated from the

product, are impurities of the product

and are thus not covered in the present

rule.

This rule requires manufacturers of

these separated byproducts to report

studies on them and on mixtures

containing them. Thus, persons who

manufacture a listed chemical as a

known byproduct that they separate

during manufacture, processing, use, or

disposal of another chemical must

report studies on the known byproducL

EPA equates these studies with studies

of the same chemicals as desired

products. The studies will be just as

telling on the effects of the chemicals.

(3) R & D Chemicals. The Third Circuit

has upheld EPA in its view that

substances manufactured for R & 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 of this

requirement, EPA has exempted persons

from reporting studies on chemical

substances that are not on the TSCA

Chemical Substances Inventory, e.g.,

new chemical substances. When a

premanufacture notice (PMN) is

submitted on a new substance, any

health and safety data on the substance

would be submitted.

B. Propose to Manufacture, Process, or

Distribute

"Propose to manufacture, process, or

distribute" is defined in this rule to

mean that a person has made a

management decision to commit

financial resources toward the

manufacture, processing, or distribution

of a chemical substance or mixture. A

company could commit financial

resources by, for example, hiring

additional personnel, commissioning a

construction engineering plan,

purchasing land to construct

manufacturing or processing facilities,

purchasing production equipment, or

contracting for raw materials.

One commenter stated that EPA

should exempt persons that propose to

manufacture, process, or distribute the

listed substances because they would

not have many studies. EPA has not

adopted this suggestion. Valuable

studies might be missed if these persons

are exempted. The Agency would be

particularly interested in the results of a

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 of the substance. These

actions are considered here as "proposed" manufacture.

Other commenters asserted that the

meaning of "propose" is clear in the

premanufacture notification provisions

of section 5 where the requirement is to

submit the notice at least ninety days

before production. EPA disagrees.

Section 5 requires a notice when a

person "intends" to manufacture a new

chemical substance, not when he

"proposes" to manufacture. When a

person is ready to submit a section 5

notice, he is beyond the initial stage in

which he "proposes" to manufacture for

purposes of section 8.

The Agency has not changed the

definition. The Agency believes it is as

specific as a definition of such a concept

can be, given the variability of

businesses covered.

C. Health and Safety Study

Many commenters argued that some

of the examples of health and safety

studies given in the proposed definition

are not "studies" in their view. They

argued that only studies designed to

provide a direct measure of effects on

human health or the environment should

be included. They cited two kinds of

studies they would exclude as not being

direct measures.

One kind was measurement of a

chemical's concentration in the

workplace or environment. Another kind

was measurements of properties of

chemicals, such as: biological,

photochemical, and chemical

degradation; air, water, and soil

transport; and water solubility, vapor

pressure, and octanol/water partition

coefficient.

The Agency disagrees with this

narrow view. The legislative history of

TSCA indicates that Congress expects

the Agency to collect a broad range of

information relevant to health and

environmental effects.

It is intended that the term (health and

safety studies) be interpreted broadly. Not

only is information which arises as a result of

a formal, disciplined study included, but

other iliformation relating to the effects of a

chemical substance or mixture on health and

the environment is also included. Any data

which bears on the effects of a chemical

substance on health or the environment

would be included. H.R. Rep. No. 94-179, 94th

Cong., 2nd Sess. 58 (1976) (Conference

Report).

All of the data EPA will obtain under

this rule, bear on the effects of chemical

substances on health or the

environment.

When measurements of a chemical's

concentration have been analyzed to

draw conclusions about occupational or

environmental exposure, a "health and

safety study" has been done. Similarly,

determinations of physical and chemical

properties that relate to a chemical's

potential for affecting health or the

environment are "health and safety

studies."

(1) Measures of concentration. The

final rule requires the submission of

analyzed aggregates of measurements

monitoring concentrations of a chemical

in the workplace or environment. These

are limited to analyses of data gathered

within five years of the effective date for

reporting on the chemical. These studies

bear significantly on the effects of a

chemical on health or the environment.

For instance, if the Agency knows that a

chemical never reaches the

environment, it would know that it will

not have an effect on the environment.

Some of the concerns commenters had

about submitting monitoring data were

because they understood the proposal to

say that all underlying data were to be

initially submitted. This would have

meant submitting a very large amount of

material. As explained below,

underlying data are not to be initially

submitted.

(2) Properties of chemicals. The final

rule requires reporting on studies of ten

properties when those studies are for

the purpose of determining the

environmental or biological fate of the

substance: (a) Water solubility; (b)

adsorption/desorption on particulate

surfaces (e.g., soil); (c) vapor pressure;

(d) octanol/water partition coefficient;

(e) density/relative density (specific

gravity); (f) particle size distribution for

insoluble solids; (g) dissociation

constant; (h) degradation by

photochemical mechanisms-aquatic

and atmospheric; (i) degradation by

chemical mechanisms-hydrolytic,

reductive, and oxidative; and (j)

degradation by biological mechanisms--

aerobic and anaerobic.

These properties of a chemical are

very important elements to consider in

assessing its potential biological effects.

For example, water solubility and

partition coefficient bear on the question

of whether a chemical could become

deposited in body fat tissues. For

another example, all of the properties

are informative on the questions of

whether a chemical released into the

environment would remain for a long

time and be transported over a large

area.

EPA decided to narrow the

requirements for submitting properties

in an effort to reduce the reporting

burden. There are other properties that

are very useful, but the Agency focused

on these ten properties as being

particularly informative, individually

and together.

Determinations of physical and

chemical properties, together with the

other studies, will give a picture of the

chemical's exposure and effects which

will permit effective evaluation of

potential risks. An evaluation of the

environmental fate of a chemical, which

is based on physical and chemical

,properties, thatinay be released to the

envirionment is of critical importance. It

is possible that a highly toxic, easily

degradable substance will be less an

object of concern than a less toxic,

persistent chemical. Recent technical

reports have indicated the importance of

environmental fate testing.

For chemicals that are likely to be released

to the environment, environmental fate

testing is equally as important as biological

effects testing. For many chemicals, adverse

biological effects were discovered following

extensive testing undertaken only after the

discovery of widespread environmental

contamination. (See Howard, P. H., et. al.

Environmental Science and Technology,

12(4), 407 (1978)).

Determining the fate of a chemical

substance in the environment and, thus,

its effects, may involve investigating the

nature of dispersal and ultimate

distribution, and the types and rates of

reactions in which the chemical

participates during transport. Fate

determinations help to identify the

chemical form(s), the environmental

compartments or concentration ranges

to which the environment will be

exposed, and the organisms exposed to

the chemical. (See 45 FR 77332,

(proposed environmental test standards)

for a further discussion of the

importance of physical and chemical

properties in determining the

environmental effects of chemicals.)
Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations 38783

(3) Underlying data. Data such as

Individual monitoring records or

employee medical records that may

underlie an epidemiological or exposure

study are not required to be submitted

as initial reports under the rule. EPA

may request these and other underlying

data such as lab notebooks as a follow

up to its examination of a study. The

Agency does not anticipate making such

requests very frequently. It will do so

when a question of interpretation arises

(such as when the Agency has studies

whose results appear to conflict) and an

examination of the underlying data may

clarify the problem.

D. Known to and Possession

As previously discussed, the Agency

has decided to delete definitions of

"known to" and "possession" and,

instead, describe the kind of file search

that will suffice for compliance with this

rule. From comments received on the.

proposed definitions, it is apparent that

the definitional approach to delineating

a responsibility to search for studies is

too indirect. The matter is discussed

further under the preamble section titled

"File Search."

II. Chemical Substances Subject to the

Rule

Section 716.17 of the rule contains a

list of chemical substances subject to

the rule. A subsection of § 716.17 is

reserved for future listing of designated

mixtures subject to the rule.

The majority of the chemicals

presently listed are ones for which the

ITC has recommended that EPA propose

testing rules. It is important that EPA

review unpublished studies on these

chemicals to avoid unknowingly

proposing testing under section 4 that

may already have been done, and to

base judgments about testing on as full

an overview of existing information as

practicable. The goal is to focus

proposals for testing as efficiently as

present knowledge will permit.

The list in § 716.17 contains two

groups of chemicals. One group consists

of the chemicals recommended by the

ITC for testing. The other group of

chemicals includes the asbestiform

varieties of chrysotile, crocidolite,

amosite, anthophyllite, tremolite, and

actinolite, i.e., asbestos, which is being

considered for control.

The bisazobiphenyl (BAB) dyes were

recommended for testing, and are the

subject of a broader Federal effort.

Assessment actions are underway at

CPSC and OSHA. In addition, the BAB

dyes are being tested by CPSC (skin

absorption) and at the National Center

for Toxicological Research (metabolism

studies).

Several chemicals in the proposed list

have been removed in the final rule. A

subset of one category of chemicals,

listed in the proposal as "organotins"

(selected by EPA) was subsequently

recommended for testing by the ITC, 45

FR 78432 (November 25, 1980). The ITC

had recommended the subset "alkyltins." However, the ITC has

subsequently removed this category

from the section 4(a) Priority List for

reconsideration (47 FR 5459). EPA has

deferred reporting on these and the

other organotins for a later proposal.

Another category of chemicals, acrylic

acid and methylacrylic acid and their

esters, has been removed from the rule.

EPA will propose the category in a

future iteration of this rule after it has

better defined the category. Dioxin and

related substances have also been

removed from the rule. Since proposing

their inclusion in this rule, the Agency

has carried out administrative

proceedings dealing with dioxin issues

which have covered the ground that

would have been covered by having the

chemicals reported under this rule.

Other chemicals removed from the rule

include acrylonitrile,

alphachlorotoluene, benzene, benzene

(epoxyethyl), chlorendic anhydride,

chlorodifluoromethane, 1,2-

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

of reasons. Some (e.g., benzene, styrene)

were the subject of earlier section 8(e]

submissions and have since been

referred to other EPA program offices or

Federal agencies for study. The

remainder were under early stages of

assessment when they were added to

the proposed rule. In the intervening

time, however, the Agency has brought

some of these assessments to near

completion, e.g., 2-nitropropane. Several comments argued that EPA

did not provide adequate public notice

and opportunity for comment because

the Agency did not state in its proposal

a reasoned explanation of how or why

each particular chemical was selected.

These comments said that the Agency

must, for each chemical, show that the

information to be reported will

contribute to articulated regulatory

objectives. In particular, they stated that

EPA must show why it believes that

each chemical might pose a risk to

health or the environment and why

published studies provide insufficient

information for conducting a risk

assessment, evaluating the need for

testing, or considering other regulatory

options. These comments also claimed

the Agency must show for each

chemical subject to the rule that the

information requested is not available

from other sources.

EPA believes it has justified, to the

extent required by section 8(d), the need

for reporting on the chemicals subject to

the final rule. The Agency disagrees

with the comments on the level of detail

required to justify reporting. The

comments would require that the

Agency prepare an extensive chemical

specific determination that would

require a search of the entire scientific

literature and all available sources and

a complete hazard analysis of the

chemical. Thus, according to the

comments, section 8(d) could be used

only to obtain information as a last

resort. This is contrary to the intent of

TSCA. There is nothing in the language

or legislative history of the Act to

indicate that section 8(d) is to be used in

such a manner. On the contrary, section

8(d) is meant to reveal information early

in the investigation phase. (See Report

of the Senate Committee on Commerce,

S. Rep. No. 698, 94th Cong., 2d Sess. 8

(1976).)

TSCA requires the Agency to provide

only a general explanation of its concern

before requesting unpublished studies

on a chemical under section 8(d).

Sufficient justification is provided if the

chemical is recommended for testing by

the Interagency Testing Committee or if

EPA staff judges that further data on the

chemical are needed for assessment.

EPA should not ignore the possibility of

obtaining data under section 8(d) when

a chemical is under evaluation by the

Agency staff.

EPA particularly disagrees that it

must show during a section 8(d)

proceeding that a chemical may present

a risk. Congress could not have intended

the Agency to make a risk finding under

a section of the statute that is designed

to reveal the hazards of a chemical.

As to the comment that EPA must

indicate for each chemical that

information required by this rule cannot

be obtained from other sources, the final

rule in fact accommodates this comment

by excluding from rule requirements any

studies available from sources to which

EPA has access-published studies and

studies submitted to other Federal

agencies without confidentiality claims.

The studies subject to the rule are those

not otherwise available to the Agency.

Several comments argue that to

provide adequate public notice and

opportunity for comment EPA must in

the proposed rule state for each

chemical subject to section 8(d) that the

information requested is not more

detailed or extensive than necessary,
38784 Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations

and will not burden more persons than

necessary with reporting obligations.

EPA concurs that as a matter of sound

policy these factors should be

considered by the Agency for this

section 8(d) rule, but disagrees that it

can prepare detailed assessments of

these factors at the time it proposes a

section 8(d) rule. In fact, EPA has

proposed this rule to solicit from the

companies that obtain commercial

advantage from the subject chemicals

comments on whether reporting on their

particular chemicals will be

unnecessarily burdensome. These

companies have or should have the

knowledge to enable the Agency to

make this decision. Indeed, the Agency

has, in response to comments,

eliminated some types of studies and

some chemicals that were originally part

of the proposal.

Many comments objected to the

Agency's automatically making subject

to the rule chemicals recommended for

testing by the ITC. These comments

claim that recommendation for testing

by the ITC is not sufficient to justify an

automatic reporting requirement. They

argue that EPA must allow the public to

present reasons why unpublished

studies should not be collected in order

to avoid imposing unnecessary or overly

burdensome reporting requirements. The

comments stated the following examples

of situations in which the public should

be able to comment on EPA's decision to

obtain studies under this rule for ITC

chemicals; EPA may be able to obtain

unpublished studies on a voluntary

basis; EPA may be able to make a

decision to proceed with or abandon

testing on the basis of information in

hand; EPA and the public may need to

consider whether studies should be

submitted on effects in addition to those

of concern to the ITC; the ITC may have

overlooked a crucial study in the

literature; voluntary testing may have

been initiated or all manufacture and

processing may have ceased.

EPA does not find this reasoning

persuasive. Within one year after the

ITC recommends a chemical for testing,

the Agency must initiate a rulemaking

proceeding to require testing under

sectioxi 4 of TSCA or publish its reasons

for not initiating such a proceeding.

Because it has such a short period of

time to make this decision, the Agency

must proceed as rapidly as possible to

gather available data on a chemical.

To decide whether to propose a test

rule within one year, the Agency needs

to be able to complete its assessment of

the known health and environmental

effects of a chemical no later than the

first four to five months after the ITC

recommendation. If studies are reported

automatically under this rule, the

Agency will receive them by the end of

the fourth month. On the other hand, if

the chemicals were proposed for

comment, an additional two to three

months would be required to give time

for the comment period, EPA writing of

responses to the comments, and EPA

preparation and publication of a final

rule. The Agency would then receive the

studies by the end of the sixth or

seventh month after the ITC

recommendation. However, by this time

EPA staff must complete their analyses

for EPA decisionmakers to consider.

EPA has previously discussed in this

preamble the importance of section 8(d)

studies in deciding whether to initiate

proceedings to require testing and has

discussed examples showing that

unpublished studies submitted

previously have been valuable in

section 4 proceedings. Receipt of

significant studies at this late stage that

could cause fundamental revision of the

basic analyses would make it

impossible to meet the Agency's oneyear deadline.

The Agency has also considered in

this section 8(d) proceeding a large

number of issues relating to reporting of

unpublished studies. The Agency has

been unable to determine, and no

comments have been presented to

indicate, that any other issues would be

raised In a comment period that would

lead the Agency not to require section

8(d) studies on ITC-recommended

chemicals. Most of the examples

described above of situations in which

the public should be able to comment on

decisions under section 8(d) on ITC

chemicals are'reasons why chemicals

should or should not be tested under

section 4. This section 8(d) rule is not for

determining whether to proceed with

testing under section 4, but is to be used

to obtain information to assist in section

4 decisions. Most of the situations

described by the comments, therefore,

would not be relevant to a section 8(d)

proceeding.

Further, EPA will not delay section

8(d) proceedings while it considers

whether to wait for studies to be

submitted voluntarily. The Agency has

found that, while studies may be

voluntarily submitted in some cases, all

companies will not do so. Inquiring after

voluntary submissions is a highly

inefficient use of Agency time and

resources and would unnecessarily

delay input into the section 4 test rule

process.

EPA's economic analysis shows that

the costs of searching for studies on ITC

chemicals in accordance with the

procedures set forth in this rule will be

very small. Further, the Agency expects

that in the future companies will

establish a system to enable more

efficient retrieval of studies requested

under section 8(d). After considering

these costs against the relatively quick

need the Agency has for studies of ITC

chemicals, EPA has determined that

such chemicals should become subject

to the section 8(d) rule as soon as

possible after the ITC recommends

them.

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 of health

and safety studies, with an appropriate

index, and the requirement to submit

lists of certain additional health and

safety studies.

A. Requirements for Submitting Copies

of Studies

Two requirements to submit copies of

studies will apply. First, any person who

has manufactured or processed or who

has proposed to manufacture or process

a substance or designated mixture listed

in § 716.17, within the ten years

preceding and including the date the

chemical is listed, will be required to

submit copies of any unpublished

studies he possesses on that chemical.

Second, EPA may request copies from

persons other than manufacturers and

processors of the 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

studies voluntarily, but would be subject

to subpoena under section 11 of TSCA if

they do not domply.

This represents a change from the

proposal which would have made all

manufacturers, processors, and

distributors subject to the copy

submission requirement. Now, only

those who actually have dealt with the

chemical must report (except

distributors).

Many comments suggested ideas for

limiting the persons subject to the rule

and limiting the types of studies to be

submitted. These ideas were:

(1) Limit the copy submission

requirement to past and present

manufacturers, processors, and

distributors of the chemicals selected by

EPA since, in the commenters' view,

these would obviously be the parties

with the greatest interest in developing

data, and thus the ones most likely to

possess it.

EPA agrees and has changed the

initial reporting under the rule

accordingly. However, EPA may later
Federal 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 of past manufacturers to

those who have manufactured since

1965, 1970, 1975, or presently

manufacture instead of since 1950 as

proposed. The commenters maintain

that these "cut-off" dates would tend to

reduce the volume of studies collected

and would maximize the quality of the

studies being collected since, in the

commenters' view, older studies tend to

be of less value.

EPA retained the reporting

requirements for past 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 1970 as a

cut-off date because they believe that

information more than ten years old

may be outdated and of little value.

Commenters agree that more

advanced analytical techniques were

used after 1950, but they maintain that

most of the more sensitive detectors and

techniques for gas 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 of the 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 result in an ever-lengthening span

as this rule is used in the future.

Most of the 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 of retired 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 more valuable, older studies

will likely have been preserved in

current files, rather than being retired. In

addition, searching long-retired files

could be vqry costly; too costly for

purchase of this rule. December 31, 1979

is the date on which potential

respondents to this rule were put on

notice of the Agency's intention to

require this reporting, and it is therefore

an appropriate date to define the limits

of the 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 of chemicals it reported

for the Inventory, and would yield the

higher quality data developed by the

manufacturer or processor.

EPA did not adopt this suggestion for

two reasons. Complete reporting for the

Inventory was limited to manufacturers

whereas section 8(d) also applies to

processors. In addition, the implicit

assumption that only those who

reported for the Inventory would have a

list of their Inventory chemicals is not

valid. All manufacturers and processors

of chemicals must know if the chemicals

they make are on the Inventory, whether

they reported for the Inventory or not.

They must know, because they must

submit a premanufacture notice to EPA

under section 5 of TSCA, before making

or processing a chemical that is not on

the Inventory.

(4) Decrease the burden of section 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, or go directly to section 4

rulemaking.

EPA did not adopt this suggestion.

Although some companies may submit

certain studies voluntarily, it is

important that EPA receive all relevant

studies. Only a section 8(d) rule can

ensure this. In addition, many

commenters stated that many studies

contain trade secret information which

companies are very reluctant to submit

voluntarily. (5) First require lists or titles of

studies that have been performed by

manufacturers or processors of the

listed chemicals and then later request

copies of selected 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 of the listed

chemicals. Effects of a substance are not

discrete items, unrelated to one another.

On the contrary, certain effects and

properties are predictive of other effects

and properties. For instance, fate and

persistence studies will help in

predicting environmental effects. Acute

toxicity studies generally provide data

to determine the median lethal dose

(LD50) of a chemical substance (its

relative toxicity), but also may provide

data to judge its mode(s) of action, 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 of studies is well

recognized as necessary to judge the

adverse effects of a chemical substance.

For example, the Organization for

Economic Cooperation and

Development (OECD) has developed a

base set of recommended tests

containing a range of tests of physical

and chemical properties and toxicity for

assessing the hazads of chemicals. It

has selected many physical and

chemical properties that, in its view,

constitute "information for degradation,

accumulation and even noxious effects

assessment * * * . For example, the

shape of a particle can, in itself, be

indicative of its carcinogenic nature

(e.g., asbestos fibers) and the partition

coefficient is indicative of likely

accumulation in lipid tissues." OECD

Chemicals Testing Programme, Expert

Group, Physical Chemistry, Final Report

Vol. I, p. 41. In addition to physical and

chemical properties, the OECD has also

included many acute, subacute, and

chronic tests in the base set of tests.

(7) Limit the chemicals subject to the

rule to "high priority" chemicals such as

ITC chemicals to match exactly the ITC

recommendations and reduce the

reporting burden,

EPA did not adopt this suggestion.

The chemicals recommended by the ITC

may be in fact the majority group on the
38786 Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations

rule, but they are not the only chemicals

on which EPA will need studies. The

hazards of other chemials are and will

be under investigation.

B. Requirements for Submitting Lists of

Studies

The final rule adopts the proposed

requirement that only current

manufacturers and processors of listed

chemicals and those who propose to

manufacture or process these chemicals

must submit lists of studies.

Several comments objected to listing

records kept on employees exposed to

chemicals. They assert that record

systems and data do not constitute a

study unless an intention to correlate

certain data to evaluate results and

reach conclusions is declared. A record

listing requirement would move the

scope of the requirements into the realm

of conjecture, and render the proposal,

in this respect at least, impracticable,

even if the thrust of this listing

requirement falls within TSCA's

authority. Quite simply, according to the

comments, there is no way to determine

to which particular chemicals any given

employee might be exposed. Interpreted

literally, this requirement would

encompass the records for all

employees, a result surely not intended

by the EPA.

The Agency agrees and has modified

the proposed listing requirements. The

studies to be listed do not include record

systems. Persons will not have to list

medical record systems or daily or

routine monitoring records. These types

of data could constitute underlying data

for an epidemiological study for

example, but are not by themselves

treated as studies.

Other commenters asserted that

protocols for ongoing studies should not

be submitted, as the proposed rule

would have required, since protocols are

not health and safety studies and

contribute no relevant health and safety

information regarding chemicals.

EPA has adopted the limitations

suggested. Copies of protocols do not

have to be submitted since they will

usually be described in the study

eventually reported. Some comments objected to listing

ongoing studies. They maintained that

section 8(d) applies only to completed

studies. EPA disagrees with this

comment. Section 8(d) authorizes listing

of a study "conducted or initiated by or

for" a company. EPA may require listing

once a study has begun because it has

been "initiated" within the meaning of

the statute.

A few comments questioned the need

for listing ongoing studies and for

submitting preliminary reports, if

requested, when an ongoing study is

listed. They asserted that partial and

incomplete data can be extremely

misleading. Also, they said a scientist

should not be required to disclose the

results of his research until the scientist

is satisfied with the accuracy, reliability,

and scientific significance of the data.

The Agency disagrees. It requires a

list of ongoing health and safety studies

to tailor testing rules to fill real gaps in

knowledge. If industry has started

enough research of a particular type, the

Agency could exclude that type of

testing from a testing rule or delay it

until the test data are available to the

Agency. For chemicals for which testing

is not contemplated, the submission of

lists of ongoing studies will help the

Agency determine the scope of possible

control regulations. If, for example, the

Agency is considering control of a

particular use of a substance, the

knowledge that a person is testing that

substance to determine its effects or

potential for exposure to man or the

environment would be valuable

information.

The Agency will not routinely require

preliminary reports to be submitted.

However, under procedures stated in

§ 716.8, EPA may ask for the submission

of preliminary reports when necessary.

The Agency understands the concern a

scientist might have about releasing

preliminary data. However, sometimes it

is necessary to track the progress of a

long-term animal study, for example, so

that the Agency can order its

assessment priorities. It is far more costeffective to monitor a study industry is

performing than to propose a testing rule

or take regulatory action that might be

found to be unnecessary when the final

test results are reported.

IV. Studies Not Subject To Mandatory

Reporting

A. Exemptions for Studies of Mixtures

The proposed rule provided four'

exceptions to the reporting

requirements. Persons did not have to

submit: (1) Copies or lists of published

studies; (2) copies of studies previously

submitted to Federal agencies with no

claims of confidentiality; (3) copies of

studies conducted by other persons

subject to the rule; or (4] copies or lists

of studies of mixtures containing small

amounts of listed substances when the

studies clearly did not reflect effects of

the listed substances. Comments

addressing items (1) through (3) above,

and EPA's responses, appear in

"General Comments on the Proposed

Section 8(d) Rule."

The exemption for reporting mixture

studies (number 4 above) generated the

greatest number of comments. The

commenters were almost evenly divided

on whether the proposed exemption or a

modified version of it should appear in

the final rule. Some comments stressed

the difficulty of predicting the effects of

a single component of a mixture from

results obtained from testing the entire

mixture. Therefore, they suggested the

Agency should not require the

submission of any mixture studies.

Other comments. suggested that the

Agency fine-tune the exemption by

requiring only submittal of a study on a

mixture containing a listed chemical

when the study was undertaken for the

express purpose of determining the

effects of the listed chemical or when

data in the study were originally

aggregated and analyzed in a manner

that directly and specifically relates to

such effects.

Weighing all of the above, EPA

decided to approach the problem

differently. As before, only studies of

mixtures in which a listed chemical is

known to be present will be submitted,

but in place of the proposed exemption,

the Agency has provided exemptions

for:

(1) Physical and chemical properties

of mixtures;

(2) Certain types of acute studies on

mixtures; and

(3) Certain aggregations of monitoring

data on mixtures. See § 716.11 (e)

through (h) of the rule for the particular

studies that are not subject to reporting.

The remaining studies to be reported

must be reported regardless of the

submitter's view of whether the studies

reflect effects of the pertinent substance.

EPA will make this judgment. By

expanding the list of studies that do not

have to be submitted and removing the

review necessary to determine which

mixture studies should be submitted, the

reporting burden on persons will be

significantly reduced.

B. "Substance" Versus "Mixture"

In the final rule (§ 716.4), EPA clarifies

how certain preparations of substances

should be treated. For example, one

commenter indicated that he considered

an aqueous solution of a substance to be

a mixture. Since one often puts a

substance into aqueous solution before

testing it for biological activity, the

commenter's view could result in many

tests being reported as tests of mixtures.

This would be an absurd result in the

context of this rule. Studies of the

following preparations of a chemical

substance must be reported as studies of

the chemical substance itself, not as

studies of mixtures 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 of maintaining the

integrity or physical form of the

substance.

(3) The chemical substance at any

grade of purity.

Studies of these preparations of

substances are classified for reporting

as studies of the substance. EPA does

not, and need not, at this time reach the

issue of whether these preparations are

defined as mixtures or chemical

substances under TSCA.

V. File Search

Because of the considerable confusion

on the part of commenters regarding the

file search required by the proposed

rule, the final rule contains a provision

describing the file search required.

Persons can satisfy the requirements of

this rule if they limit their search for

information to files in which such

information is expected to be found in

the ordinary course of their business,

and the files of employees Whose

assigned duty is to advise the company

on the health and environmental effects

of chemicals.

The actual mechanics of the search

can be approached in a number of ways

depending on the size of the company

and the type of chemicals for which

studies will be submitted. EPA includes

the following discussion to convey how

it believes a satisfactory search might

reasonably be conducted with the least

expenditure of resources. The Agency is

not saying that this is how companies

must search.

For small to medium size companies

that believe they are subject to the rule

and have few studies of any kind, it may

be more cost effective to scan the titles

of the studies they possess and then

check to see if the chemical studied is

on the list of chemicals subject to the

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 of studies

are indexed. Alternatively, they might

determine the chemicals they handle(d]

then search for studies.

The Agency expects the search for

physical and chemical properties to be

minimal for all companies because of

the very limited number of properties

that are subject to the rule. Also, the

Agency expects that companies will

have a special reference file for the most

standard properties such as solubility or

vapor pressure. 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 if these studies were performed.

Companies possibly subject to the

rule because a listed substance is a

component of a mixture should be able

to examine the mixture studies they

possess to see if any components of the

mixture studied are on the section 8(d)

chemical list. Since most of the studies

normally performed on mixtures are

exempted by the rule, most companies

will only have 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

of studies no later than sixty days after

the effective date of promulgation of the

list of chemcial substances and mixtures

in J 716.17. The rule also provides for

extending the submission deadline for a

reasonable period, if a company

requests such an extension because of

long file searches.

Because they assumed a very

extensive file search was required,

many commenters suggested that sixty

days was insufficient time to comply

with the rule. EPA is retaining the

proposed schedule becau~se it has made

significant changes to reduce the search

burden. The scope of this final rule is

less than that of the previous section

8(d) rule under which companies

reported in 1979 since many exemptions

to the required studies and the

responsibilities of respondents have

been made. No company requested an

extension of time for reporting under the

rule's sixty-day schedule. Based on the

1979 experience, and because of the

reduced scope of this rule, the Agency

believes that sixty days is an

appropriate period. As proposed, the rule would have

required that persons subject to the list

submission requirement inform EPA of

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. The Agency has changed the

requirement. Under the final rule, these

persons will be responsible only for

informing EPA of studies initiated by or

for them, rather than of any new 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 to EPA

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 of mutagenicity, carcinogenicity, or

teratogenicity; and the biological and

environmental fate tests listed in

§ 716.10(h) through (j).

Another concern of the comments was

that the five-year period for reporting

completion of ongoing studies or

initiation of new ones is too long,

especially since EPA must act on

chemicals recommended by the ITC

within twelve months.

The Agency believes that a multiyear

period is necessary. The action required

within twelve months is to initiate

rulemaking, or give EPA's reasons for

not doing so. Promulgating a test rule or

entering into a voluntary testing

agreement will require consideration

over a longer period during which new

data of the initiation of new studies

could affect EPA's final action. Even

after a test rule is promulgated or a

voluntary testing agreement is reached,

new data on substances under test will

be important in the Agency's evaluation

of the chemical subsequent to testing

and could contribute to a decision

whether control action for the chemical

is indicated. However, to balance EPA's

needs against the burden of this

requirement, EPA has decided to

maintain a multiyear approach but to

limit it to three years. EPA believes that

this represents a minimal 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 if he decides that

further reporting is not needed.

VII. Confidentiality

EPA is aware of the need to protect

confidential business information.

Several commenters suggested that the

regulations should contain a specific

statement about the means EPA would

use to protect the confidentiality of

information in the unedited copy of a

study.

The TSCA Confidential Business

Information Securuty Manual contains

the' procedures for physically

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.

(The manual is available from the OPTS

Industry Assistance Office-see FOR

FURTHER INFORMATION CONTACT.) EPA

will share confidential information with

contractors, other EPA offices, and other

Federal agencies only in accordance

with these procedures. In addition, all

information claimed as confidential is

subject to the legal procedures in 40 CFR

Part 2 with respect to disclosure by EPA.

A person submitting a health and

safety study may claim all or part of the

study confidential. However, health and

safety information about a chemical that

has been offered for commercial

distribution or is subject to testing under

section 4 or notice under section 5 can

be withheld from disclosure only to the

extent that disclosure would reveal (1)

processing information and (2) percent

composition of mixtures, or contains

information the disclosure of which

would clearly be an unwarranted

invasion of personal privacy (such as

individual medical records), as provided

in 5 U.S.C. 552(b)(6).

Any claims of confidentiality must be

made at the time of submission, as

provided in 40 CFR 2.203(a)(2) and in the

manner specified in § 716.16 of this

regulation. This rule requires submission

of two copies of studies containing

confidential material-one copy

indicating what data are claimed as

confidential and one copy without the

confidential information. EPA will

presumptively consider failure to submit

the second copy as a waiver of the

confidentiality claim. However, EPA

will notify respondents who claim parts

of studies confidential that they did not

submit the required second copy. This

provision affords persons the

opportunity to correct errors within 30

days. Commenters raised a number of

issues concerning specific provisions of

the proposed regulation that detail the

methods for submitting confidential

information.

One assertion was that subrnitters

should not be burdened with "up front"

substantiation for claims of

confidentiality, and that such

substantiation should be required only if

EPA receives a Freedom of Information

Act (FOIA) request for the information.

The Agency will not require "up front"

substantiation. The language of

§ 716.16(c) has dropped the requirement

that the basis of the claim be "explicitly" explained at the time of

submission. The claim must still be

explained briefly. However, this

explanation should merely be a simple

statement indicating that the reason for

the claim is, for example, related to

mixture proportion or process

information, or that the information is

clearly irrelevant to the health and

safety study. EPA does not expect

detailed substantiation of confidentiality

claims at the time the study is

submitted. The Agency believes that this

simple statement is justified, because

EPA needs some understanding of the

claim to have a basis for initial denial or

granting of FOIA requests and to protect

the information.

Another suggestion was that failure to

provide a nonconfidential second copy

of a study for which claims are made

should not be considered a presumptive

waiver of the claim. The commenter

asserted that the claim to a trade secret

is a property right and cannot be taken

away by the operation of a presumption.

In their view, once the claim is made, it

must stand unless a disclosure request is

made and FOIA principles require that it

be granted.

EPA will not place confidential

information in the public file

automatically if a second copy is not

received. The Agency will notify the

respondent that it has not received a

second copy. This will allow the

company to correct the situation.

Another commenter claimed that the

20-day grace period for correcting

incomplete confidentiality submissions

does not allow the respondent sufficient

time to respond.

The rule has been changed to extend

the proposed 20-day grace period to 30

days. This should be adequate for such

a straightforward response, even given

mail delays, because the only step

needed is to provide a second, 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

of health and safety studies from such

claims.

EPA disagrees that it should not allow

confidentiality claims. Respondents may

claim any information as confidential;

however, the only information which the

Agency may actually keep confidential

is listed in § 716.16(c).

VIII. Economic Impact

EPA estimates that the total cost to

industry of submitting lists and copies of

health and safety studies under the

present rule is approximately $537,000.

The major cost to a firm will be the

cost of a file search to determine what

health and safety studies it possesses.

This cost will, of course, vary directly

with the size of the firm, assuming that

larger firms have more files at more

locations which must be accessed. Once

the studies are located, the remaining

compliance costs involve copying and

processing the studies, making lists of

studies which are in progress or not in

the possession of the respondent, and

reviewing the studies for confidential

information. The Agency's cost

estimates are based on the cost to an

average firm. EPA recognizes that actual

costs will be larger or smaller for larger

or smaller firms. Each of these costs is

tabulated below.

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 of chemicals subject to the rule,

these cost per chemical estimates can be

used to determine the cost of the

additional reporting.

If the studies submitted allow EPA to

eliminate even one potential section 4

mandated test on a subject chemical, the

cost avoided could exceed the total cost

of this rule. For example, EPA estimates

that it will cost industry from $700,000 to

$1,300,000 to perform the proposed

testing (see 45 FR 48557) for

chloromethane and up to $4,900,000 for

chlorobenzenes (see 45 FR 48557).

The Agency received many comments

suggesting that its original estimate of

$410,000 total cost was too low. The

comments pointed to many features of

the proposed rule that they believed

would cause much greater burdens than

the Agency had assumed. However,

only a few comments actually gave EPA

estimates of the time or money they

would expend in complying with the

proposal. For example, the Chemical

Manufacturers Association suggested

from a survey of thirteen of its members

that the cost per company would be $400

to $10,000 per chemical, but this range

estimate was not accompanied by data

to indicate how the figures were

generated.

The following is a list of the most

burdensome features of the proposal as

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 for medical
No. 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 the future, but only

if they are underlying 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 be present in a

studied mixture and in then deciding

whether the listed substance was

responsible for whatever effect the

study showed.

The Agency has substantially changed

the requirements for submitting studies

on mixtures. It has excluded most acute

studies from the requirement; it has

excluded all physical/chemical

properties of mixtures; and the Agency

has excluded studies of mixtures that

contain the listed chemical only as an

impurity. In addition, the Agency 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 of submitting mixture studies

substantially. The changes mean that

companies can go directly to their

copies of studies on mixtures to see if a

listed chemical was in a mixture tested.

The number of studies to belooked at

has been much reduced. And, most

importantly, companies will not have to

search records to find out what

impurities may have been present in the

studied mixture.

(3) The proposal would have required

companies who may never have dealt

with a chemical to submit studies on it if

they had then. EPA has removed this

burden by changing the requirements to

apply to those who have manufactured

or processed or have proposed to

manufacture or process the chemical.

Moreover, the Agency has said that

companies can determine their

association with the chemical by looking

at their current files. This will alleviate a

concern expressed by companies whose

ownership or activities have changed

and whose records have been retired.

(4] Perhaps the greatest burden cited

was that of potentially searching every

company file for studies or references to

studies. The proposal was broadly

worded in this respect. The final rule

contains a section describing the much

more limited search that will be enough

to comply with the rule. Companies will

comply if they search the files where

studies are kept in the ordinary course

of their business, and the files of those

employees whose assigned duty is to

advise the company about health and

environmental effects of chemicals.

(5) Comments have requested that

studies on research and development

chemicals be exempted. They requested

the exemption for a number of reasons,

one being that these studies may be in a

different set of files at different

locations than other studies. EPA has

not fully exempted these studies (see R

& D Chemicals) because, as previously

discussed in this preamble, the Agency

does not believe that the fact that a

studied chemical has been in research

and development is relevant to the value

of the study. However, by better

defining the file searches required for

compliance with the rule the Agency has

reduced the burden of searching for such

studies.

(6) The report's impact analysis for

the proposal did not include the burden

to a company to familiarize itself with

the rule. Commenters remarked on this,

and the Agency has included this item in

the final analysis. (7) The report's impact analysis for

the proposal did not consider the cost of

file searches which must be conducted

by firms which will not actually find

submittable studies in their file.

Commenters suggested EPA account for

these costs.

In the first analysis, EPA attempted to

base cost estimates upon the prior

experience of firms which reported for

the original section 8(d) rule. These data

did not reflect the experience of firms

which conducted futile file searches,

and did not report. The Agency believes

that for the purposes of a report impact

analysis, the previous experience of the

prior section 8(d) rule is the firmest

estimate that the Agency can utilize.

However, EPA has now attempted to

estimate costs for those companies that

handle the listed substances, but have

no studies to report. The Agency did this

by searching the TSCA Inventory to

determine the number of companies that

reported the listed substances and then

multiplying this number by a factor of

three to account for processors and

distributors.

Although some commenters indicated

that the scope of the rule extends

beyond the "chemical industry" and

woudl therefore increase the potential

number of processors of the listed

substances beyond our estimate, EPA

believes that its estimates or

respondents is proper for the following

reasons. First, over 85 percent of the

companies that reported for the first

section 8(d) rule were concentrated in

the chemical, allied products, and

petroleum refining industries. Second,

most of the comments received from

companies on the proposed rule were

from companies in those industries,.

which EPA believes is an indicator of

the respondent population for the final

rule. Third, EPA believes that almost all

of the studies performed on the listed

substances are initiated by the

manufacturers and primary processors

of the substances, which is the reason

EPA exempted distributors from

reporting. These companies are heavily

concentrated in the chemical, alliedproducts, and petroleum refining

industries.

Furthermore, the changes, exemptions,

and limited file search prescribed in this

rule should eliminate the possibility of a

substantial burden of unavailing

searches.

(8) The analysis accompanying the

proposal did not consider the ongoing

cost of reviewing newly completed

studies during the multiyear follow-up

period.

EPA does not believe that

consideration of ongoing 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 of this 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 to both 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 of firms or companies, not the

average number of sites], 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

of 2.2 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 of chemicals in the

rule. They specifically asked for better

definitions of the categories or for lists

of the chemical in the categories for

which EPA wants studies. Because of

chemical nomenclature complexities, the

commenters suggested that the burden

of deciding whether a given chemical

should be counted in or out could be

great. EPA has eliminated one of the more

troublesome categories from the listacrylic acid and methylacrylic 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 the information

number given at the beginning of this

notice. EPA staff will be available to

return these calls and answer questions.

The basic elements EPA has included

in the final Reports Impact Analysis are:

(a) Corporate rule review-2 hours at

$50 per hour.

(b) Corporate identification of

pertinent files--3 hours at $50 per hour.

(c) File search at plant site--6 hours at

$30 per hour.

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

per hour.

(e) Photocopying per study-%K hour at

$15 per hour.

(f) Final review before submission-1

hour at $50 perhour.

EPA's estimate of total cost of the rule

uses the above figures and assumes that

891 firms will perform an initial review;

447 firms will submit 3,784 reports of 50

pages each; and each firm has, on a

weighted average, 1.5 plant sites.

The corporate rule review step was

suggested by commenters, as was the

corporate identification of locations to

be searched. EPA has increased the

hourly costs of managerial review and

file searches by $10 each from previous

estimates, and increased the file search

-time per site from four to six hours.

These new estimates are based upon

suggestions from commenters and the

changes EPA has made to rule

requirements. One caveat that must be

kept in mind is that these are average

costs. Individual firms may experience

greater or lesser costs depending on

their size.

EPA received comment that one hour

for final review before submission

would not be enough to accommodate

decisions on confidentiality. The

Agency's estimate of an average of one

hour review per study is reasonable.

EPA does not expect that a company

should have to scrutinize a study for

confidential information just before it is

submitted to EPA. Confidential

information in a study should already

have been identified as such by the

company. For example, to get a court to

prevent disclosure of confidential

information, a company must be able to

show that the information was given

special treatment by the company, i.e.,

marked confidential, or kept in limited

access files. Therefore, the Agency

believes that most of the information in

a study that is confidential will have

been previously identified as such by

the company, and it should not be

necessary to check with virtually every

department of the company, 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 index is available for

inspection in the OPTS Reading Room,

Ran. E-107, 401 M'Street, SW,

Washington, DC, 20460, from 8:00 a.m. to

4:00 p.m. Monday through Friday, except

legal holidays. This record includes

basic information considered by the

Agency in developing this rule.

Following is a list of the documents

which constitute the record for this

rulemaking. Public comments on the

proposed rule are ndt individually listed,

but will be available upon request in the

OPTS reading room. EPA requests that it

be notified of any additions or deletions

to this record within the next 30 days.

(1) Health and Safety Study Reporting

Regulations, July 18,1978, Public Record,

Docket No. 084001.

(2] Manufacturing Chemists AssociationPetition under section 21 of TSCA, September

12, 1978.

(3) Denial of Citizens' Petition, 43 FR 56724-

56727.

(4) The entire docket in Dow Chemical

Company v. United States Environmental

Protection Agency, et o. Docket No. 78-2203

(3rd Cir.).

(5] Revocation of Rule, 44 FR 6099.

(6) Reports Impact Analysis of this

rulemaking.

(7) All comments on this rule, including any

comments received from the Office of

Management and Budget during Paperwork

Reduction Act review.

(8) General Comments on the Proposed

Section 8(d) Rule.

(9) All relevant support documents and

studies.

(10) Records of all communications

between EPA personnel and persons outside

the Agency pertaining to the development of

this rule. (This does not include any inter- or

Intra-agency memoranda unless specifically

noted in the index of the rulemaking record.)

(11) Minutes, summaries, or transcripts of

any public meetings held to develop this rule.

(12] Any factual information considered by

the Agency in developing the rule.

X. Regulatory 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

major because it does not have an effect

of $100 million or more on the economy.

It is expected to have a one-time cost of

about $725 thousand. It does not have a

significant effect on competition, or

costs or prices.

This regulation was submitted to the

Office of Management and Budget for

review as required by Executive Order

12291.

Regulatory Flexibility Act

Since this rule was proposed before

the effective date of the Regulatory

Flexibility Act, 5 U.S.C. 601 et seq., the

Act's requirements do not apply..

However, based on the Agency's

experience with a previous section 8(d)

rule, it expects that only about 1 percent

of the respondents will have gross sales

of less than 20 million dollars.

Paperwork Reduction Act

Information collection requirements

contained in this regulation (§ § 716.6

and 716.7) have been approved by the

Office of Management and Budget

(OMB) under the provisions of the

Paperwork Reduction Act of 1980 U.S.C.

3501 et seq. and have been assigned

OMB Control Number 2070-0004.

This rule requires manufacturers and

processors of 40 chemicals and

categories of chemicals to submit

unpublished health and safety studies

relating to these chemicals. The studies

to be submitted will be used by EPA

evaluating health and environmental

effects of chemicals for purposes of

assessing risks associated with the

chemicals, as well as in determining

whether the chemicals should be

included in testing rules issued under

section 4 of TSCA.

Lists of Subjects in 40 CFR Part 716

Chemicals, Health and safety,

Environmental protection, Hazardous

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,

Acting Administrotor.

Therefore, Chapter I of Title 40 of the

Code of Federal Regulations is amended

by adding a new part 716 consisting at

this time of Subpart A to read as

follows:

PART 716-HEALTH AND SAFETY

DATA REPORTING

Subpart A-General Provisions

Sec.

716.1 Scope and compliance.

716.3 Definitions.

716.4 Overview of subpart requirements.

716.6 Submission of copies of studies.

716.7 Submission of lists of studies.

716.8 EPA requests for submission of further

information.

716.9 How to 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 lists of substances and

designated mixtures to which this

subpart applies. 716.19 Sunset provision.

Authority: Sec. 8(d), Pub. L 94-469, Stat.

2029 (15 U.S.C. 2607(c)).

Subpart A-General Provisions

§ 716.1 Scope and compliance.

(a) This Subpart sets forth

requirements for the submission of lists

and copies of health and safety studies

on chemical substances and mixtures

selected for priority consideration for

testing rules under section 4(a) of the

Toxic Substances Control Act (TSCA)

and on other chemical substances and

mixtures for which EPA requires health

and safety information in fulfilling the

purposes of TSCA.

(b) Section 15(3) of TSCA makes it

unlawful for any person to fail or refuse

to submit information required under

this Subpart. Section 16 provides that a

violation of section 15 renders a person

liable to the United States for a civil

penalty and possible criminal

prosecution. Under section 17, the

district courts of the United States have

jurisdiction to restrain any violation of

section 15.

§ 716.3 Definitions.

The definitions in section 3 of TSCA

apply to this Subpart. In addition, the

following definitions are provided for

the purposes of this Subpart:

(a) "Byproduct" means a chemical

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 of another

chemical substance(s) or mixture(s).

(c) "Copy of study" means the written

presentation of the purpose and

methodology of a study and its results.

(d) "EPA" means the United States

Environmental Protection Agency.

(e) "Health and safety study" or "study" means any study of any effect

of a chemical substance or mixture on

health or the environment or on both,

including underlying data and

epidemiological studies, studies of

occupational exposure to a chemical

substance or mixture, toxicological,

clinical, and ecological or other studies

of a chemical substance or mixture, and

any test performed under TSCA.

(1) It is intended that the term "health

and safety study" be interpreted

-broadly. Not only is information which

arises as a result of a formal, disciplined

study included, but other information

relating to the effects of a chemical

substance or mixture on health or the

environment is also included. Any data

that bear on the effects of a chemical

substance on health or the environment

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 for ecological or other

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 or bioaccumulation

tests, and model ecosystem (microcosm)

studies.

(iii) Assessments of human and

environmental exposure, including

workplace exposure, and impacts of a

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,

vapor pressure, evaporation rates from

soil and water, octanol/water partition

coefficient, and water solubility.

(iv) Monitoring data, when they have

been aggregated and analyzed to

measure the exposure of humans or the

environment to a chemical substance or

mixture.

(f) "Importer" means any person who

imports a chemical substance, including

a chemical substance as a part of a

mixture or article, into the customs

territory of the United States and

includes the person primarily liable for

the payment of any duties on the

merchandise or an authorized agent

acting on his behalf Jas defined in 19

CFR 1.11). Importer also includes, as

appropriate:

(1) The consignee.

(2) The importer of record.

(3) The actual owner, if an actual

owner's declaration and superseding

bond has been filed in accordance with

19 CFR 141.20.

(4] The transferee, if the right to draw

merchandise in a bonded warehouse has

been tranferred in accordance with

Subpart C of 19 CFR Part 144.

For the purpose of this definition, the

customs territory of the United States

consists of the 50 States, Puerto Rico,

and the District of Columbia.

(g) "Impurity" means a chemical

substance which is unintentionally

present with another chemical

substance.

(h) "Manufacture" and "Process"

mean manufacture or process for

commercial purposes.

(i) "Manufacture for commercial

purposes" means:

(1) To import, produce, or manufacture

with the purpose of obtaining an

immediate or eventual commercial

advantage for the manufacturer, and

includes, among other things, such

"manufacture" of any amount of a

chemical substance or mixture:

(i) For commercial distribution,

including for test marketing.

(ii) For use by the manufacturer,

including use for product research and

development, or as an intermediate.

(2) The term applies to substances

that are produced coincidentally during

the manufacture, processing, use, or

disposal of another substance or

mixture, including both byproducts and

coproducts that are separated from that

other substance or mixture and

impurities that remain in that substance

or mixture. Byproducts and impurities

may not in themselves have commercial

Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations 38791
38792 Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations

value. They are nonetheless produced

for the purpose of obtaining a

commercial advantage since they are

part of the manufacture of a chemical

product for a commercial purpose.

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 of the Federal

government. (k) "Process for commercial purposes"

means the preparation of a chemical

substance or mixture, after its

manufacture, for distribution in

commerce with the purpose of obtaining

an immediate or eventual commercial

advantage for the processor. Processing

of any amount of a chemical substance

or mixture is included. If a chemical

substance or mixture containing

impurities is processed for commercial

purposes, then those impurities are also

processed for commercial purposes.

(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)

of TSCA, 15 U.S.C. 2602(2)(A).

(n) 'TSCA" means the Toxic

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 file search for

compliance with this subpart. Persons

are not required to search any records

retired prior to December 31, 1979 for

information to comply with this subpart.

In addition, the scope of a company's

responsibility to search records is

limited to records in which it ordinarily

keeps the required information and to

records kept by individual employees

whose assigned duty is to advise the

company of the health and

environmental effects of chemicals

under § 716.12.

(b) Persons who must report. (1) A

person who manufactures or processes a

substance or designated mixture listed

in § 716.17 at the time it is listed, or

proposes to do so, must do the following

for that substance or designated

mixture-(i) Submit copies of all nonexempted studies in his possession at

the time he becomes subject to the rule

under § 716.6. Under § 716.14 the copies

must be submitted within 60 days after

the addition of the substance or

designated mixture to § 716.17.

(ii) Under § 716.7 submit a list of

studies that are ongoing when the

substance or designated mixture is

added to § 716.17. The list must be

submitted within 60 days after the

addition of the substance or designated

mixture to § 716.17 and copies of such

studies must be submitted within 30

days of their completion under § 716.14.

(iii) Inform EPA within 30 days of any

study initiated by or for him after the

initial 60 day reporting period and

submit a copy of the study when it is

completed. This requirement continues

until the sunset date specified in

§ 716.19; it applies not only to persons

who manufacture or process a substance

or designated mixture when it is added

to the list, but also to persons who begin

to manufacture or process, or propose to

do so at any time prior to the sunset

date.

(2) A person who is not covered under

paragraph (b)(1) of this section, but has

manufactured or processed a substance

or designated mixture listed in § 716.17,

or has proposed to do so, anytime in the

preceding ten years, must submit copies

of studies in-his possession on the

substance or designated mixture within

60 days of when it is added to § 716.17.

(c) Studies to be reported. In general,

studies, as defined at § 716.3(d), that are unpublished are reportable, i.e., must be

submitted or listed, for any substance or designated mixture listed in § 716.17.

However, this requirement has

limitations according to the nature of the

material studied, so that-(1) All studies

of substances and designated mixtures

are reportable. However, in the case of

physical and chemical properties, only

those studies listed in § 716.10 must be

submitted.

(2) Studies of mixtures known to

contain substances or designated

mixtures listed in § 716.17 are reportable

except for studies of physical and

chemical properties and the studies

exempted at § 716.11(f) (1) through (6).

(3) Studies of substances or

designated mixtures that a person who

is reporting has manufactured or " processed or proposed to manufacture

or process only as impurities are not

generally reportable under § 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 of copies of-studles.

(a)(1) Except as provided in § § 716.10

and 716.11, persons must send to EPA

copies of any health and safety studies

in their possession for the substances or

designated mixtures listed in § 716.17.

Persons are responsible for submitting

copies on only the substances or

designated mixtures which they have

manufactured or processed or proposed

to manufacture or process (including as

known byproducts) within the ten years

preceding the effective date for reporting

on the substances or designated

mixtures. Persons who list studies as

ongoing under § 716.7(a)(1) must submit

them when they are completed.

(2) Underlying data, such as medical

or health records, individual files, lab

notebooks, and daily monitoring records

supporting studies, do not have to be

submitted initially. EPA may request

underlying data later under § 716.8.

(b) Submissions under paragraph (a)

of this section must be indexed by

chemical name, including CAS number if

known, and must be accompanied by a

cover letter containing the name, job

title, address and telephone number of

the submitting official, and the name

and address of the manufacturing or

processing establishment on whose

behalf the submission is made. In the

cover letter, respondents must identify

any impurity or additive known to have

been present in the substance as studied

unless its presence is specifically noted

in the study itself.

(c) Copies of health and safety studies

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 lists of studies.

(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 of the

substances or designated mixtures listed

in § 716.17 which they manufacture or

process or propose to manufacture or

process (including as known

byproducts).

(1) A list of ongoing health and safety

studies being conducted for or initiated

by them, noting for each entry the

purpose of the study, type of data

collected, and progress and anticipated

date of completion. This requirement

continues until the sunset date specified

by § 716.19. Studies initiated after the

initial 60 day reporting period must be

listed if they included one or more of the

following tests: chronic tests; long- and

short-term tests or mutagenicity,

carcinogenicity or teratogenicity; and
Federal 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 of unpublished studies

known to them of which they do not

have copies. The name and address of

any person known to them to possess a

copy of the unpublished study must

accompany each entry on the list. For

purposes of this section only, an

unpublished study will be considered to

be "known to" a person, if the study can

be discovered by a file search in

accordance with § 716.12.

(b) Submissions under paragraph (a)

of this section must be indexed by

chemical, including CAS number if

known, and must be accompanied by a

cover letter containing the name, job

title, address and telephone number of

the submitting official, and the name

and address of the manufacturing or

processing establishment on whose

behalf the submission is made.

(c) The list of health and safety

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 requests for submission of

further information.

EPA may request the following

submissions after the initial reporting

under § § 716.6 and 716.7. If the

requested submissions are not made,

EPA may subpoena them under section

11 of TSCA, 15 U.S.C. 2610.

(a) Submission of underlying data of

the kind described in § 716.6(a)(2) by

persons who submit copies of studies

under § 716.6 or list studies under

§ 716.7(a)(1).

(b) Submission of preliminary reports

of ongoing studies by persons who list

the studies under § 716.7(a)(1).

(c) Submission of copies of studies by

persons listed under § 716.7(a)(2) as

possessing them.

§ 716.9 How to report on substances and

mixtures.

Section 716.17 contains two lists, one

of substances and one of designated

mixtures. Studies of listed substances

and designated mixtures shall be

reported as follows:

(a) When a substance is individually

listed under § 716.17(a), studies -of the

substance and studies of mixtures

known to contain the substance must be

reported as studies of that substance.

(b) When two or more substances are

listed as a designated mixture under

§ 716.17(b), studies of the designated

mixture and studies of any mixture

known to contain the designated

mixture must be reported as studies of

the designated mixture.

(c) Studies of the following

preparations of a substance must be

reported as studies of the substance

itself, not as studies of mixtures known

to contain the substance.

(1) The substance in aqueous solution.

(2) The substance containing a small

amount of an additive, such as a

stabilizer, emulsifier, or other chemical

added for purposes of maintaining the

integrity or physical form of the

substance.

(3) The substance at any grade of

purity.

§ 716.10 Reporting physical and chemical

properties.

Studies of physical and chemical

properties must be reported under this

subpart if performed for the purpose of

determining the environmental or

biological fate of a substance, and only

if they investigated one or more of the

following properties:

(a) water solubility.

(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 from the

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 or under

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 of chemical substances

which are not on the TSCA Chemical

Substance Inventory, e.g., research and

development studies on new chemical

substances.

(f) The following types of studies

when the subject of the 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.

If the 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 or more substance or

designated mixtures listed in § 716.17,

when the monitoring data are not

analyzed to determine the exposure or

concentration levels of the substances

or designated mixture listed in § 716.17.

(i) Studies on a substance or

designated mixture listed in § 716.17

that the person who is reporting has

manufactured or processed or proposed

to manufacture or process only as an

impurity. When reporting of such studies

is to be required, that reporting will be

separately proposed in the Federal

Register.

§ 716.12 File search.

Persons will satisfy the requirements

of this Subpart if they limit their search

for the required information to records

in which such information is expected to

be found in the ordinary course of their

business, and to information kept by

employees whose assigned duty is to

advise the company on the health or

environmental effects of chemicals. For

purposes of this rule, persons do not

have to search files retired prior to

December 31, 1979.

§ 716.14 Reporting schedule.

(a) Except as provided in paragraphs

(b) and (c) of this section, submissions

under § § 716.6 and 716.7 must be

postmarked on or before 60 days after

the effective date of the listing of a

substance or designated mixture in

§ 716.17 or within 60 days of proposing

to manufacture or process a substance

or designated mixture if first done after

the effective date of the substance's or

designated mixture's listing in § 716.17.

(b) Persons subject to the listing

requirement of § 716.7 must inform EPA

of any study initiated by or for them

within the three-year reporting period

described in § 716.19 within 30 days of

initiation of the study. Copies of studies

listed as ongoing under § 716.7(a)(1), or

studies initiated within the reporting

Federal Register I Vol. 47, No. 171 / Thursday, Septeinbei 2, 1982 / Rules and Regulations 38793
38794 Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations

period, must be submitted within 30

days of their completion. (c) Respondents who cannot meet a

deadline under this section may apply

for a reasonable extension of time.

Requests for extensions should be

addressed to: Document Control Officer,

Office of Pesticides and Toxic

Substances, (TS-793), Environmental

Protection Agency, 401 M Street, SW,

Washington, D.C. 20460, Attn: Section

8(d) extension.

§ 716.16 Confidentiality claims.

(a) Any person submitting a document

under this Subpart may assert a

business confidentiality claim covering all or part of the submitted material.

Any information covered by a claim will

be disclosed by EPA only as provided in

procedures set forth at Part 2 of this

title.

(b) If no claim accompanies a

document at the time it is submitted to

EPA, the document will be placed in an

open file available to the public without

further notice to the respondent.

(c)(1) Section 14(b) of TSCA states

that EPA may not withhold from

disclosure, on the grounds that they are

confidential business information,

health and safety studies of any

substance that has been offered for

commercial distribution or for which

testing is required under TSCA section 4

or for which notice is required under

TSCA section 5, except to the extent

that disclosure of data from such studies

would reveal: (i) processes used in the

manufacturing or processing of a

substance or mixture, or (ii) the portion

of a mixture comprised by any of the

substances in the mixture.

(2) Any respondent who wishes to

assert a claim that part of a study

should be withheld from disclosure

because disclosure would reveal a

confidential process or quantitative

mixture composition or other

confidential information, should briefly

state the basis of the claim, i.e., by

saying "reveals confidential process

information" or "reveals confidential

mixture proportion data," and clearly

identify the material subject to the

claim. Information in a study, such as

company name or address, financial

statistics, or product codes used by a

company, which is irrelevant to any

health or environmental effect of a

chemical, may be claimed confidential

and not subject to the disclosure

requirements of section 14(b) of TSCA.

Other information contained in a study,

the disclosure of which would clearly be

an unwarranted invasion of personal

privacy (such as individual medical

records), will be considered confidential

as provided in Title 5, United States

Code, section 552(b)(6).

(d) To assert a claim of confidentiality

for data contained in a submitted

document, the respondent must submit

two copies of the document.

(1) One copy must be complete. In that

copy, the respondent must indicate what

data, if any, are claimed as confidential

by marking the specific information on

each page with a label such as "confidential," "proprietary," or "trade

secret" and briefly state the basis of the

claim.

(2) If some data are claimed as

confidential, the respondent must

submit a second copy. The second copy

must be complete, except that all

information claimed as confidential in

the first copy must be deleted.

(3) The first copy will be for internal

use by EPA. The second copy will be

placed in an open file to be available to

the public.

(4) Failure to furnish a second copy

when information is claimed as

confidential in the first copy will be

considered a presumptive waiver of the

claim of confidentiality. EPA will notify

the respondent by certified mail that a

finding of a presumptive waiver of the

claim of confidentiality has been made.

The respondent will be given 30 days

from the date of receipt of notification to

submit the required second copy. If the

respondent fails to submit the second

copy within the 30 days EPA will place

the first copy in the public file.

§ 716.17 Substances and designated mixtures to which this subpart 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

R2 R= =f H H or or alkyl alkyl

R3 = 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

1464-53-5
Federal 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

R2 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"OR2 "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

Substances (examples for groups)

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

R3 alkyl; or phenyl, either

unsubstituted or substituted

with one or more alkyl or

aralkyl groups

Asbestos - Asbestiform varieties of:

chrysotile (serpentine); crocidolite

(riebeckite); amosite (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

634-90-2
Federal 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.

H20-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,' R 3

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-C
Federal Register / Vol. 47, No. 171 / Thursday, September 2, 1982 / Rules and Regulations 38799

§ 716.18 Additions to Hats of substances

and designated mixtures to which this

subpart applies.

The requirements of this Subpart will

periodically be extended to cover

additional substances and designated

mixtures. Two procedures will be used

to add substances and mixtures.

(a) Except'as provided in paragraph

(b) of this section, substances and

designated mixtures will be added after

publication in the Federal Register of a

notice of proposed amendment of this

subpart. There will be a 30-day public

comment period on the notice; after

consideration of the comments, a final

amendment will identify the substances

and mixtures added.

(b) Substances and designated

mixtures that have been recommended

for testing by the Interagency Testing

Committee, established under section 4

of TSCA, will become subject to this

subpart 30 days after publication of a

notice to that effect in the Federal

Register.

§ 716.19 Sunset provision.

The reporting period on a substance

or designated mixture will terminate no

later than three years after that

substance or designated mixture is

added to the list in § 716.17. The

automatic termination date for the three

year reporting period on a substance or

mixture will be the. annual sunset date

(May 1 or November 1) that falls no later

than three years after reporting begins,

e.g., a reporting requirement taking

effect on January 1, 1982 would expire

not later than November 1, 1984. A

notice will be published in the Federal

Register announcing the termination

date for reporting for the substances and

designated mixtures listed in § 716.17 (a)

and (b). An earlier termination date may

be published for a substance or

designated mixture at the discretion of

the Assistant Administrator for

Pesticides and Toxic Substances.

[FR Do. 82-24058 Filed 9-1-82; 8.45 am)

BAJNG CODE 6660-50-M