Federal Register / Vol. 47, No. 120 / Tuesday, Tune 22, 1982 / Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 712

[OPTS-82004F; FRL 2039-7]

Chemical Information Rules;

Manufacturers Reporting; Preliminary

Assessment Information

AGENCY. Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This final Preliminary

Assessment Information rule requires

chemical manufacturers (including

certain producers and importers) to

submit information on approximately

250 chemicals. The information sought

from manufacturers includes data on the

quantities of chemicals manufactured,

the amounts directed to certain classes

of uses, and the potential exposures and

environmental releases associated with

the manufacturer's own and his

immediate customers' processing of the

chemicals. The information collected

under this rule will answer a critical

need for basic data that can be used in

setting priorities for testing chemicals

and for assessing risks associated with

chemicals.

EFFECTIVE DATE: This regulation

becomes effective on July 22, 1982.

FOR FURTHER INFORMATION CONTACT.

For further information on this rule, or to

obtain copies of the Manufacturer's

Reporting Form, contact: Douglas G.

Bannerman, Acting Director, Industry

Assistance Office (TS-799], Office of

Pesticides and Toxic Substances,

Environmental Protection Agency, Rm.

E-511B, 401 M St., SW, Washington, DC

20460, Toll-free: (800-424-9065), In

Washington, DC: (554-1404), Outside the

USA: (Operator-202-544-1404).

SUPPLEMENTARY INFORMATION:

OMB Control Number: 2000-0420.

I. Introduction

Proposed amendments to this final

rule are published elsewhere in this

issue of the Federal Register.

EPA proposed a rule under section

8(a) of the Toxic Substances Control Act

(TSCA) to obtain general use and

exposure data on 2,226 chemical

substances published in the Federal

Register of February 29, 1980 (45 FR

13646). More than 150 written comments

were received on the proposal and

several meetings were held with

members of the public. The Agency also

received a petition from the Chemical

Manufacturers Association requesting

that the Agency provide dossiers and

other information on the 2,226 chemicals

for purposes of public comment. EPA

responded to the petition in the Federal

Register of April 28, 1980 (45 FR 28173).

This preamble explains the final rule's

provisions and addresses by topic the

changes EPA has made to simplify,

clarify, and reduce the burden of the

rule. A document titled "Responses to

Individual Comments" responds to

substantive comments individually. This

document is available to the public in

the administrative record of this

rulemaking and is considered to be

incorporated byreference here. Some

comments are not discussed because

changes in the final rule, particularly

changes in subject chemicals, have

made the issues moot.

After considering comments, the

Agency has changed certain provisions

and significantly reduced the number of

chemicals. The changes to the

provisions will reduce the burden of

reporting without greatly decreasing the

value of the information that the rule

will collect on each chemical. Also in

response to comments, the Agency has

added explanatory material to clarify

the requirements. Because of these

changes, the Agency has changed the

format of the final rule. The rule is now

arranged in three Subparts. Subpart A

contains general provisions applicable

to the entire Part. Subpart B contains

reporting requirements for chemical

manufacturers. Subpart C will contain

the chemical processors' reporting

requirements proposed separately

today. This arrangement should allow

manufacturers and processors to more

easily identify the provisions to which

they are subject.

Elsewhere in this issue of the Federal

Register, EPA is proposing three

amendments to this final rule. One

amendment is the plan for follow-up

reporting by processors. Another change

would require reporting automatically

within 60 days on chemicals

recommended for testing under section 4

of TSCA by the Interagency Testing

Committee (ITC). The third change

would make about 50 additional ITCrecommended chemicals subject to

reporting under this rule. These

chemicals were listed in ITC reports 5

through 9.

A. Rule Design: Two Part Reporting

The final rule anticipates two rounds

of reporting. In the first round,

manufacturers of chemicals listed in

§ 712.30 of the rule must submit

Preliminary Assessment Information

Manufacturer's Reports. The reports

must be submitted to EPA within four

months of the effective date of the rule.

The manufacturer's report includes

items on the use of a manufacturer's

chemical by his customers, when the

customers are also processors of the

chemical. However, manufacturers may

report "unknown" for their processorcustomers' uses either when

manufacturers do not know the

customers' uses to within ±50 percent

accuracy, or when the information is

subject to a secrecy agreement between

the manufacturer and customer.

The Agency will aggregate the

customer use data for each chemical. If

manufacturers report customer uses

unknown for over 20 percent of the total

amount of a chemical manufactured and

imported, the Agency plans to initiate a

second round of reporting, this time by

processors, in order to complete its

assessments. As noted above, the

procedures for this second round of

reporting are proposed for comment in a

separate notice today.

B. Purpose of the Rule

The information collected under this

rule will answer a critical need for basic

data that can be used in setting

priorities for testing chemicals and for

assessing risks associated with

chemicals.

For the majority of the chemicals

presently listed, ITC has recommended

that EPA propose testing rules. Under

TSCA section 4, within 12 months of

ITC's recommendation, EPA must

initiate rulemaking for testing or publish

a notice explaining why a test rule is not

necessary. Information on potential

exposure is needed for the decision.

Unfortunately, available exposure

information has rarely been adequate

for a decision. As a result, EPA has had

problems making the decisions required

by statute. This rule will allow test rule

decisions to be based on more complete

and accurate potential exposure data.

A few chemicals on the rule were

identified by public notices of

substantial risk under TSCA section

8(e). For the listed 8(e) chemicals, EPA

does not have sufficient exposure

information to determine the extent of

risks presented. When this rule provides

the exposure data, EPA will be able to

evaluate and recommend appropriate

action for these 8(e) substantial risk

notices.

We have changed the focus of the first

edition of the rule to serve only the most

immediate needs for assessment, of test

candidates and 8(e) reports. Therefore,

we eliminated from the rule those

chemicals proposed for purposes of

general problem identification. These

include chemicals proposed because of

their high production volume, chemicals

which the ITC has been unable to

completely evaluate because of lack of

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Federal Register / Vol. 47, No. 120 / Tuesday, June 22, 1982 / Rules and Regulations

exposure data, and a small number of

chemicals from other sources described

in the notice of proposed rulemaking.

I. Who Must Report

A. Persons Included

1. Manufacturers. The term "manufacture" under TSCA includes

importing and producing as well as

manufacturing activities. Persons must

report on each listed chemical substance

that they manufactured for commercial

purposes in the reporting period

specified for the chemical. Discussion of

the application of this rule to producers

and importers follows.

2. Producers-Miners and oil refiners.

Questions were asked during the

comment period about the application of

this rule to mining of chemical

substances. The concern was that listed

chemical substances are present in

mined substances in variable or

undefined concentrations and that a

single chemical substance may be

reported as "manufactured" more than

once in the stream of commerce.

Commenters felt that it must be made

clear precisely at what point they are "manufacturing" a specific chemical

substance that is present in a mined

substance. We have provided

clarification both here and in the rule.

Any method of extraction, refinement,

or purification of the mined substance to

make it marketable as a listed chemical

substance is to be regarded as "manufacture of a listed chemical

substance" for the purposes of this rule.

An undefined or variable concentration

mixture not intended for marketing as a

listed chemical is not subject to this rule.

In general terms, mining can be

regarded as extracting a substance from

the atmosphere, earth, or sea. The most

common methods are digging ores and

drilling oil. Many persons mine complex

substances containing listed chemicals

in undefined or variable concentrations,

but do not refine the mined substance in

order to extract a particular chemical

substance for use or sale. Some of the

chemicals subject to this rule may be

present in and produced from these

complex precursor substances.

However, because EPA has excluded

undefined, variable composition

substances from the list of chemicals

subject to this rule, production or mining

of the undefined, variable composition

precursor is not to be reported. Only

subsequent steps devoted to production

of the listed chemical are reportable.

For example, persons who

manufacture a chemical substance such

as "sweetened naphtha, 64741--87-3,"

but do not refine the naphtha to produce

"hexane, 110-54-3" would not report on

hexane. Only the production of

"hexane" as an isolated product must be

reported-not previous production of

more crude, complex substances such as

the naphtha from which hexane is

extracted.

3. Importers. Persons must report on

any chemical substance listed in

§ 712.30 that they imported in bulk for

commercial purposes during the

reporting period.

Importers should report chemical

substances imported in bulk in any

grade of purity, in aqueous solution, or

containing additives (such as stabilizers

or other chemicals) to maintain the

integrity or physical form of the

substance. This does not include

formulated mixtures of two or more

chemicals that are not additives.

The chemicals that must be reported

are those that are marketed and used as

a chemical listed in § 712.30. Such

chemicals were identified by name and

CAS number on the Inventory regardless

of purity and must be reported for this

rule as chemical substances. The

additives, for example, are merely to

enhance the ability to use the single

major component chemical, as with

antioxidants. It is still the chemical

substance per se that is being marketed

and used, and that must be reported for

this rule.

EPA interprets TSCA to provide that

importers of mixtures are importers of

any chemical substance contained in

such mixtures. Alternatively, to the

extent that such products may

technically be considered mixtures as

defined under TSCA, EPA has

determined that effective enforcement of

TSCA requires us to obtain data on such

products. This is because a chemical

substance in aqueous solution or

containing additives is used as the

chemical substance per se, and such

products may account for a substantial

amount of exposure to the chemical.

B. Exemptions From Reporting

Most of the comments supported the

exemptions to reporting in the proposed

rule. The proposed exemptions have

been adopted. In addition, the final rule

contains an exemption suggested by

commenters to exclude reporting on the

manufacture of less than 500 kilograms

annually at a plant site. The Agency

estimates that this exemption will

exclude about 170 reports. Excluding

reports of these small production

quantities will not affect assessment of

the chemicals and so will relieve an

unnecessary reporting burden.

III. Reporting Form for Manufacturers

A facsimile of the Manufacturer's

Report-Preliminary Assessment

Information form appears in § 712.28.

The data reporting section of the form

(Section IV) has two parts: Part A: Plant

Site Activities and Part B: Chemical

Substance Processing by Customers.

Pioduction, processing, and use at each

single domestic manufacturing site must

be reported on Part A, including the

number of workers, uses, and process

types employed, and quantities of the

chemical that are or are not recovered.

Part B of the form applies to the

processing of the chemical by others.

Part B will account for the quantity of

chemical that is distributed from the

manufacturing plant site. Altogether, the

form identifies where a chemical is

made and in what quantities, how many

workers are potentially exposed during

manufacture, processing, and use at the

manufacturing plant site, what likely

environmental releases exist, and what

quantities are used in various categories

of uses both by the manufacturer and as

the chemical moves into commerce.

In Part A, items I and 2 ask for total

quantities of the chemical imported and

domestically manufactured. Item 3

covers quantities lost during

manufacture. Items 4, 5, 6, and 7 ask for

quantities, worker-hours, and number of

workers associated with enclosed,

controlled release, and open process

categories. Item 4 covers manufacture of

the chemical; item 5 covers on-site use

as a reactant; item 6 covers on-site nonreactant use; and item 7 covers on-site

preparation of products. Item 8 asks

how much of the chemical the

manufacturer makes into products to be

used by industry or by consumers; these

products include the chemical itself and

mixtures containing the chemical,

articles with some release of the

chemical possible, and articles with no

release. All of the above Part A items

concern the manufacturer's own

activities and use of his own products.

Part B concerns the activities of the

manufacturer's immediate customers

(processors). Item 9 parallels item 8 of

Part A; it asks how much of the chemical

the customer makes into products to be

used by industry or by consumers in

various forms. Item 10 asks for the trade

name(s) under which the manufacturer

markets the chemical to his customers.

This item is only to be answered if the

manfacturer reports that his customers'

uses are unknown for more than 20

percent of the quantity of chemical

manufactured and imported. Item 11

asks the manufacturer to estimate,

based upon his general knowledge of

industry practices, the quantity of the

chemical that is processed by his

customers in enclosed, controlled, or

open processes, respectively.

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26994 Federal Register / Vol. 47, No. 120 / Tuesday, June 22, 1982 / Rules and Regulations

A. Readily Obtainable Data

TSCA section 8(a) authorizes EPA to

require information that is "known to or

reasonably ascertainable by" the

respondent. This is defined at § 712.3(g)

as "all information in a person's

possession or control, plus all

information that a reasonable person

similarly situated might be expected to

possess, control, or know, or could

obtain without unreasonable burden."

For purposes of this section 8 rule, the

Administrator has determined that a

lesser standard should apply. The rule requires persons to report

data that are readily obtainable by

management and supervisory employees

responsible for manufacturing,

processing, distribution, technical

services, marketing, and other related

activities. These knowledgeable people

are responsible for providing estimates

and associated accuracy levels for the

data elements on the form. The

comments supported this standard.

B. Accuracy for Reporting

The proposal discussed options for the

accuracy to be required for reporting

quantities of a chemical under the rule.

As the proposal stated, exact numbers

will not be required. We consider that

permitting estimates to be reported will

provide data sufficient for the purposes

of this rule and will make the reporting

easier. Comment was requested on

various options for the required

accuracy. These were: accuracy of ±50

percent for all quantities; accuracy of

±10 percent or ±20 percent on a

person's own activities and ±50 percent

on others' activities; or allowing respondents to specify the accuracy. We

have decided that the accuracy should

be related to the activity reported. For

most of Part A of the form, dealing with

a manufacturer's own activities,

estimates must be the best estimates

from readily obtainable data, but no

specific accuracy range will be required.

For items 3b, 3c, and 3d relating to

losses during manufacture, accuracy

must be specified by the respondent. For

Part B of the form, dealing with

processor-customers' activities,

quantities must be reported within ±50

percent.

We are persuaded that manufacturers

must routinely know their own

production efficiencies and quantities in

order to control their costs and price

their products. Thus, when

manufacturers report about their own

activities, the best estimate from readily

obtainable data would be sufficiently

accurate. There is no need for the

company to expend further effort to

report more exactly. For example, it will

be legitimate for a company to report

figures based on design capabilities of a

process. Thus if a process is planned to

utilize or produce a certain quantity per ..run" or per unit time, or is planned to

produce a certain quantity of product

from a defined quantity of feedstock

material, then the company may assume that the design quantities are the actual

quantities, and not attempt to account

for variations.

Most of the companies who

commented favored the broadest

possible limits on accuracy of quantities

reported. Except for the questions

relating to losses during manufacture

and customer activities, companies

simply endorsed broad limits without

discussion. They cited no specific

difficulties in reporting on quantities

going into and coming out of their own

production processes. One commenter in

fact said, "If we do it, we know it." The

Agency has concluded that reporting on

the basis of readily obtainable data will

not impose significant burdens.

Based on review of comments and our

intention to ease the reporting burdens,

the final rule allows estimates for

worker-hours and numbers of workers,

as well as for quantities of the chemicals

to which workers will be exposed. The

estimates for worker-hours and number

of workers should be based on readily

obtainable data.

Items 3a, 3b, 3c, and 3d deal with

losses during manufacture of the

chemical. Comments said lack of

measured data presented a serious

difficulty in meeting the proposed level

of accuracy for quantities reported on

question 3a. For the final rule,

manufacturers may calculate the total

loss for question 3a by finding the

differences between the quantities

theoretically manufactured, and

quantities actually used or sold. For

items 3b, 3c, and 3d, we have decided to

allow respondents to simply tell us the

accuracy of the quantities reported. The

following difficulties were cited for

reporting the destiny of losses: many

times the amounts lost are very small,

on the order of parts per million, and a

10 percent or 50 percent difference

would be insignificant or unmeasurable;

routine methods for analyzing emission

or effluent amounts do not exist in most

cases; and in some cases there are

multiple sources of loss that would

make calculations extremely difficult.

We have concluded that by allowing

companies themselves to specify the

accuracy of the figures, based on readily

obtainable data, we will receive the

estimates we need, without imposing

unnecessary burdens. Companies are not required to conduct monitoring to

comply with this rule; they may answer

this item by mass balance estimates.

The accuracy of reporting customer

activities under item 9 of the proposed

form received the greatest attention

from commenters. Most commenters felt

that quantities of a chemical processed

by individual customers in enclosed,

open, or controlled release operations

would be beyond their knowledge in

most cases. Furthermore, the proposed

item 9 asked for quantities of chemicals

by customer use and process category in

a combined matrix. This simultaneous

accounting for quantities would have

required a customer-by-customer

accounting, followed by sorting and

aggregating quantities into 16 matrix

boxes. In the view of most companies,

this complicated accounting together

with their lack of knowledge of

customer processes would have resulted

in frequent reporting of quantities as "unknown."

We have changed the reporting of

customer activities in response to

difficulties described in comments. The

final form has two items, 9 and 11, to

cover customer activities. Item 9 now

asks for quantities by customer use

within ±50 percent accuracy.

Commenters indicated that this could be

done. Where respondents cannot report

within ±50 percent, or where they have

a secrecy agreement with the customer,

they may report "unknown." Item 11

now asks for the respondent's estimate

of the kinds of processes generally used

for the chemical.

In general, manufacturers should

report information on their customers'

uses to the extent that this information

is known. Manufacturers are not

required to obtain additional

information from customers for this rule.

C. Reporting Worker-Hours, Number of

Workers, and Quantities: Items 4-7

As a result of comments, EPA has

simplified reporting of worker-hours,

number of workers, and quantities by

process category under items 4-7. Only

the workers directly assigned to the

manufacturing, processing, and use of'

the chemical should be counted.

Maintenance workers should be counted

only if they are directly assigned to and

are a regular part of a process.

When answering the items on workerhours or number of workers,

respondents must (i) identify the process

category (enclosed, controlled release,

or open) with which the worker spends

the most time, and (ii) determine the

number of workers involved with a given process category. For multiprocess

operations, workers operating more than

one process category should be listed
Federal Register / Vol. 47, No. 120 / Tuesday, June 22, 1982 / Rules and Regulations

only once-under the process category

with which they work most of the time.

This should avoid double counting of

workers.

Worker-hours need not be calculated

from detailed production records, but

may be based on design factors. That is,

worker-hours may be estimated from the

plant's production of a given chemical

and the design number of employees

needed to achieve that production. - The final rule simplifies reporting by

requiring the total number of workers

involved in each process category, and

deleting the proposed distinction

between full and part-time workers. The

number of workers should include

employee turnover, and will not

necessarily correspond to worker-hours.

Include all employees who work on a given chemical's production or

processing, regardless of the length of

time of employment.

Instructions have been clarified

regarding items on the quantity of a chemical that goes through each process

category. Chemical production could

involve a single process or a multiprocess operation, a split stream

involving different processes, or two

separate streams involving different

processes (e.g., one stream might be for a reagent grade chemical and another

for a technical grade). The instructions

discuss how to handle reporting in these

differing circumstances.

D. Preparation and Uses of

Manufacturer's Products: Items 7 and 8

The form has been revised to identify more clearly the distinct activity of onsite product preparation (making a product containing the manufactured

chemcial). Item 7 in the final rule applies

only to plant sites that both manufacture

and process a chemical. If a manufacturer of a listed chemical also

produces a formulated mixture or other

industrial or consumer product

containing the chemical, he must report

the chemical quantities, number of

workers, and process categories in this

question.

Item 8 asks for the quantities of the

substance incorporated into various use

categories of products produced by the

manufacturer at the reporting site. This

item also incorporates proposed

question 12 on export of the chemical

substance (as the chemical or as part of a product).

Commenters thought we should

differentiate between institutional and

industrial uses to better judge

exposures. We do not believe that this

degree of differentiation will contribute

to the evaluation of a chemical without more information on the manner of use

of the chemical. Therefore, for the

purposes of this rule, "industrial" and

"institutional" products are treated in

the same manner.

Commenters said the definition of

consumer products should have the

same exemptions as listed in the

Consumer Product Safety Act (15 U.S.C.

2052(a)(1)(D)) (CPSA). We have not

adopted this suggestion. Our purpose in

citing CPSA is simply to help

differentiate between consumer and

industrial products. Thus, the CPSA

definition, without its exemptions, is

included in the rule to guide

manufacturers in categorizing their

products.

E. Categorizing Uses Under Items 8 and

9

Items 8 and 9 differentiate products

into articles containing listed chemicals

versus products that are chemical

substances or mixtures. Articles are

further differentiated into those

designed so that there is no release of

the chemical during normal use, versus

articles that may allow direct user

contact with the chemical during normal

use. In evaluating exposure potential,

chemicals in "articles with no release"

will be considered as having potential

exposure only during disposal or

mishandling of the article.

One commenter said that fabrics with

dyestuffs retained on them should be

considered as articles containing

chemicals. We agree. These would

generally be "articles with some

release" since the chemical dyestuffs

would be in direct contact with the user.

F. Customer Uses: Items 9. 10, and 11

Items 9 and 11 ask the manufacturer

to estimate the quantities of the

chemical that his customers

incorporated into various categories of

products, exported, consumed as

reactant, and processed by various

categories of process. The manufacturer

is to base his estimates on his

knowledge of the market for the

products and his customers' roles in that

market.

If manufacturers do not know how all

quantities of the marketed chemical are

used by customers, or if a use is subject

to a secrecy agreement with the

customer, the amount may be reported

as "unknown". If the manufacturer

reports that more than 20 percent of the

total quantity manufactured and

imported has unknown uses, in question

10 he must provide the trade names

under which he marketed the "unknown" amount. The Agency, as

discussed below, will use the trade

names for processor reporting, if it

becomes necessary for that chemical.

G. Follow-up Reporting

Nearly every industry comment

requested that EPA eliminate the

proposed requirement to submit

customer lists for purposes of follow-up

reporting on customer data that are

unknown to manufacturers. Commenters

cited several difficulties with the

approach, including their own

confidentiality concerns and the burden

of making up the lists when there are

many customers. In addition, some

pointed to the potential burden for all

concerned, including EPA, of having

follow-up proceed by mailing of letters

back end forth. This would be difficult,

especially when manufacturers have

customer addresses for deliveries rather

than addresses for technical contacts.

The Agency sees merit in many of the

comments on the proposed approach

and is proposing a different one in a

separate proposed rule elsewhere in this

issue of the Federal Register. The

separate notice describes the new

proposal and discusses the comments

already received on processor reporting.

In general, under the new approach, the

Agency would aggregate the

manufacturers' reports on a chemical. If "unknown" uses are reported for more

than 20 percent of the aggregate quantity

manufactured and imported, the

chemical will be the subject of follow-up

reporting by processors. The market

names for the chemical will be taken

from the responses to question 10 of the

manufacturers' reporting forms. These

names will be published, and processors

of the chemicals under these names will

report about them. This approach is

based on commenters' suggestions that

EPA should specify criteria that would

trigger follow-up reporting, and that EPA

should publish trade names on which

processors must report in order to

protect the confidentiality of chemical

product composition.

H. Time Allowed To Report

For the final rule, we based the time

allowed to report on comments, changes

in provisions of the rule and form, and

the significantly decreased number of

chemicals subject to reporting. From

available data, we estimate the average

and median number of reports for a

manufacturing site now to be 2.8 and 2,

respectively. The maximum number of

reports from any site is expected to be

35; the site with 35 reports has over $1

billion sales annually. Based on these

data, four months from the effective date

of the rule should allow enough time for

reporting. .

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26996 Federal Register / Vol. 47, No. 120 / Tuesday, June 22, 1982 / Rules and Regulations

. Reporting Period

The Agency received comments

saying that records of data to be

submitted under this rule are often kept

by a corporate fiscal year that does not

coincide with the calendar year, and

that it would be difficult for these

companies to report by calendar year as

originally proposed. To reduce this

aspect of the reporting burden, EPA has

changed the reporting period in the final

rule. A company should report a

chemical's production during the

company's most recent complete

corporate fiscal year as of the date the

chemical is listed in § 712.30. This is the

reporting period referred to in the

discussion of reporting requirements for

manufacturers. Even though these

reporting years may vary somewhat

among manufacturers, the disparity will

not significantly affect the value of the

data for purposes of this rule.

.Plant Site Reports

In response to comments that it would

be burdensome for companies to

aggregate data from their plant sites

before submitting it to EPA, the final

rule now requires a form to be submitted

for each plant site. Thus the address of

the plant site must now be provided on

the form, along with the Dun and

Bradstreet number for the plant site

when that number exists. The reporting

company may decide whether to have

headquarters or individual sites

complete forms, depending on which is

more convenient for the company. This

approach also allows EPA to gather

data that can be compared to the sitespecific data on the Inventory. This

comparison will allow the Agency to

assess changes in the dimensions of

potential exposure, and to consider

potential local problems.

A question was raised in the

comments about whether a company

manufacturing a chemical to order for

another company should submit the

form or let the buyer submit it. The

answer is that the actual manufacturer,

not the buyer, should submit the form.

K. Recordkeeping

Commenters expressed concern over

the proposed requirement to maintain

records that support information

submitted to EPA. The proposed fiveyear retention period was said to be too

long and too burdensome. The Agency

agrees that this provision should be

deleted. The records supporting

reporting under this rule will be records

that companies will retain as a matter of

business. Companies should be alert to

the possibility that they may be required

to report under this rule in the future

and consider or, if necessary, reconsider

their recordkeeping practices in that

light.

IV. Chemicals Subject to the Rule

The final rule applies to the

approximately 250 chemical substances

and three categories listed by CAS

number in § 712.30. Manufacturers and

importers must report on these

substances. (An alphabetized list of the

chemicals can be requested from the

Industry Assistance Office at the

telephone number given at the beginning

of this notice.) The three categories of

chemicals need be considered only by

persons who reported confidential

chemical identities for the Inventory.

We wish to note that we will use

future iterations of this rule to collect

information on additional chemicals.

One list of additional chemicals is

proposed for comment separately in this

issue of the Federal Register. We are

also separately proposing that certain

chemicals be placed automatically on

the list and that reporting be

immediately required on those

chemicals without proposal and

comment.

Commenters wanted EPA to list the

names of all chemicals that must be

reported for this rule, and not to list any

category names of chemicals. The

Agency does not intend that reports be

submitted on all chemicals that fall

within the listed categories. The purpose

of listing the categories is to require

reporting on certain chemicals that are

confidential on the TSCA Inventory.

(Listing the CAS number of a

confidential chemical would

automatically divulge its identity.) Of

the chemicals that fall within listed

categories, a manufacturer must report

only on the chemicals that he claimed

confidential for the TSCA Inventory.

V. Other Issues

A. Small Manufacturers

Section 8(a)(3) of TSCA requires the

Administrator to consult with the Small

Business Administration and then to

prescribe, by rule, standards to

determine who may qualify as a small

manufacturer or processor. Such small

businesses are then exempt from section

8(a) rule requirements. However, if a

chemical substance is subject to certain

proposed or final actions by the Agency,

EPA need not apply the section 8

exemption for small businesses

manufacturing or processing the

chemical. Among the actions that could

remove the small business exemption

are proposed rules under section 4, 5, or

* 6 of TSCA. Although several chemicals

in the list published today are subject to

section 4 proposals, EPA has decided

not to require any reporting by small

businesses. The additional data from

those companies would not significantly

influence the overall preliminary

assessments.

For this rule, for a plant site to qualify

as small with respect to a listed

chemical, a manufacturer or importer

must meet both of the following criteria:

i. Total annual sales taken together of

all sites owned or controlled by the

foreign or domestic parent company

were below $30 million for the reporting

period.

As chemicals become subject to this

rule in the future, the Agency will

consider the need to adjust this dollar

figure to-reflect inflation. Sales figures

would be based on activities at all of the

plant sites of the reporting firm, its

parent, and all subsidiaries owned or

controlled by the parent company. The

parent company owns or controls

another company if the parent owns or

controls 50 percent or more of the other

company's voting stock, or other equity

rights, or has the power to control the

management and policies of the other

company.

ii. Total production of the listed

substance for the reporting year was

below 45,400 kilograms (100,000 pounds)

at the plant site.

The EPA has consulted with the Small

Business Administration in developing

the exemption standard for the rule. The

exemption criteria for this rule have not

changed from the proposal, except for

the addition of a factor to correct the

sales cutoff for inflation.

B. Confidentiality

1. Certification. Some commenters

noted that the effort they would have to

spend to substantiate claims of

confidentiality by answering the

proposed substantiation questions

would exceed that spent in answering

the substantive questions presented in

the form. After considering comments,

we have concluded that the method of

substantiation outlined in the proposal

was overly burdensome and that a

simplified method of substantiation

should be adopted for this rule.

For the final rule, in order to claim

any information on the form as

confidential, the respondent must

certify, as in the Inventory Reporting

Regulations, that the claims of

confidentiality are made in good faith

and that the four listed statements are

true. This simplification will

substantially reduce industry's

expenditure of time, money, and

personnel.
Federal Register / Vol. 47, No. 120 / Tuesday, June 22, 1982 / Rules and Regulations

The final reporting form has separate

signature blocks for confidentiality

certification and for technical accuracy

certification. This should alleviate the

concerns of commenters who said that

an importing subsidary may not be able

to certify to confidentiality claims for

information supplied by a foreign

parent. In this case, the foreign parent

can certify regarding confidentiality and

the U.S. subsidiary can certify the

accuracy of data.

2. Release of data to the public.

Industry and public interest groups

expressed concern as to whether or not

EPA planned to publish aggregates of

data from this rule or publish only those

discrete data items that are not claimed

confidential. One public interest group

preferred that the Agency release

discrete data elements not claimed as

confidential. They felt this would aid

people in identifying local problems.

Industry generally favored publishing

aggregates of the data.

There are two purposes for releasing

data received by the Agency:

i. To allow the phblic and the states to

conduct local activities to identify and

control risk situations, and

ii. To allow public comment on the

aggregate data the Agency uses to make

its decisions.

The first purpose seems best served

by the release of discrete data items that

have not been claimed confidential.

However, comments indicated most of

the reported data will be legitimately

claimed to be confidential business

Information. Therefore, the public would

be likely to receive only incomplete data

that had not been claimed confidential.

Moreover, the release of discrete nonconfidential data elements would limit

the release of the aggregate data used in

risk assessments; discrete nonconfidential data could be subtracted

from the aggregate to reveal secret data.

Given these considerations, we have

decided to release the following types of

non-confidential data:

i. Identification of a firm or plant site

that manufactures or processes a

chemical, except when this fact is

confidential.

ii. Aggregate data on production, uses,

and workers for each chemical.

It will be necessary for us to withhold

some data that have not been claimed

confidential in order to protect

confidential data within an aggregate.

However, the Agency will determine its

aggregation method in a manner that

will allow as much data as possible to

be released, but that will not allow

confidential information to be

recognized by the public. By releasing

aggregate data we will be able to share

information with the public, including

the regulated industry.

VL Economic Impact

EPA estimates that chemical

manufacturers will spend a maximum of

$760,000 to report on the approximately

250 chemicals on this rule.

The fixed costs per plant site to

comply with the rule are estimated at

$480. This includes time to become

familiar with the reporting requirements,

and time to determine which listed

chemicals the plant site produces.

Variable costs of compliance are

estimated at an additional $420 per

report that must be submitted. The

variable costs include time to determine

the information required, to determine

whether the information should be

claimed as confidential, and to complete

the form and certification requirements.

For the median company, the rule will

cost a maximum of about 0.004 percent

of its profit. This is not a balance sheet

loss, but a theoretical cost based on time

the company will spend searching for

data.

The fixed and variable cost estimates

were based on the number of hours that

would be required to complete a form.

EPA estimated an average of 18 hours

for a site to become familiar with the

rule, determine which chemicals to

report on, and put together a final

package for submittal to EPA. This

figure could be lower or higher

depending on how many forms are

involved. An additional 16 hours were

estimated for a site to complete each

form. At an average of 3 reports per site,

these estimates allow 66 hours (18+(3

X 16)) for an average site's compliance.

TSCA Inventory data show that about

450 plant sites will submit a total of

about 1,300 reports. The plant sites

represent about 330 companies, for an

average of about 4 reports per company.

VII. Rulemaking Record

The administrative record for this rule

(docket number OPTS 82004) contains

the following documents. All documents,

including the index to this public record,

are available to the public in the OPTS

Reading Room from 8:00 a.m. to 4:00 p.m.

weekdays, Rm. E-107, 401 M St., SW.,

Washington, DC 20460. This record

includes basic information considered

by the Agency in developing the final

rule. The record includes the following

information, which is more specifically

described in the TSCA Section 8(a)

"Level A" Rulemaking Index to the

Public Record:

(1) The Advance Notice of Proposed

Rulemaking (OTS-82004a), published in

the Federal Register of June 27, 1979 (44

FR 37517).

(2) Initial Report of the TSCA

Interagency Testing Committee

published in the Federal Register of

October 12, 1977 (44 FR 55026).

(3) Written comments to the

Advanced Notice of Proposed

Rulemaking, numbered 1 through 33

(OPTS-82004a).

(4) Chronologically ordered

preproposal comments, minutes, and

released drafts, numbered I through 15.

(5) The proposed rule, "General

Recordkeeping and Reporting

Requirement: Preliminary Assessment

Information" (OPTS-82004b), published

in the Federal Register of February 29,

1960 (45 FR 13646).

(6) Petition presented to EPA on

March 17, 1980 by the Chemical

Manufacturers Association (CMA), and

EPA's response, published in the Federal

Register of April 28, 1980 (45 FR 28173).

(7) Support documents, including:

(a) "Chemical Source List" File,

describing the sources and criteria used

to select the chemicals for this rule.

(b) High volume criterion, confidential

file 20-8020030.

(c) Economic Impact Analysis and

references.

(d) "Chemical Use List" and

references to its file (OPTS-10001),

published in the Federal Register of July

25, 1978 (43 FR 32222).

(e) Inter-agency survey by EPA,

including all correspondence with other

agencies in reference to this rule.

(f) Support documents for final sec.

8(a) "Level A" rule, Including inter-,

Intra-agency, and outside

correspondence in reference to this rule.

(8) All written comments to the

Proposed Rule (OPTS-82004b).

(9) Telephone comments to khe

Proposed Rule (OPTS-82004b).

(10) Notices concerning the proposed

rule: corrections to the rule published in

the Federal Register of April 7, 1980 (45

FR 23473), and April 18,1980 (45 FR

26386), and a notice of public meetings

published in the Federal Register of

April 28, 1980 (45 FR 28176).

(11) Transcripts of public meetings on

the Section 8(a) "Level A" Rule.

(12) Miscellaneous agency comments,

corrections, and correspondence relating

to the rule.

(13) Cross references to test rules

developed under TSCA section 4(a).

(14) Any comment received from the

Office of Management and Budget

during its review of the rule regarding

compliance with the Paperwork

Reduction Act, or Executive Order

12291.

(15) The document titled "Responses

to Individual Comments," which

contains Agency responses to comments

26997
26998 Federal Register / Vol. 47, No. 120 / Tuesday, June 22, 1982 / Rules and Regulations

on the proposed rule. This document is

also considered to be incorporated by

reference in this Federal Register notice

of the final rule.

Additional documents may be added

to the Public Record. Within 30 days of

the date of publication, please notify us

of any errors or omissions in the Public

Record. Address all correspondence to:

Document Control Officer (TS-793),

Office of Pesticides and Toxic

Substances, Environmental Protection

Agency, 401 M St., SW., Washington,

D.C. 20460.

VIII. Regulatory Assessment

Requirements

A. Executive Order 12291

Under Executive Order 12291, EPA

must judge whether a regulation is "Major" and therefore subject to the

requirement of 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 maximum cost to

chemical manufacturers of about

$760,000. It does not have a significant

effect on competition, employment,

investment, productivity, innovation, or

ability of U.S. based enterprises to

compete with foreign-based enterprises

in domestic or export markets. This

regulation was approved without

comment by the Office of Management

and Budget (OMB) as required by

Executive Order 12291.

The information submitted under this

rule will cost manufacturers

approximately $3,000 per chemical. It is

difficult to put an absolute value on

information, but the Agency has

experienced costs of $10,000 per

chemical for even fruitless searches of

general reference sources for exposure

information. The information to be

reported, general as it is, will be of much

greater quality and thus reliability than

any data otherwise available. When the

information is used by EPA and other

Federal agencies to set priorities among

chemicals, the rule will benefit the

public primarily by identifying chemical

hazards and thus allowing reduction of

risks to health and the environment. The

rule will also save public and private

time and expense by directing

regulatory attention away from many

chemicals of lesser apparent risk. The

potential value of the rule's information

thus will be much greater than the cost

of reporting.

B. 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, this rule is consistent with the

Act's objectives in that it exempts small

businesses from reporting under this

rule. EPA consulted with the Small

Business Administration, Size Standards

Division, in developing this exemption.

C. Paperwork Reduction Act

Information collection requirements

contained in this regulation 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 2000-

0420.

This rule requires manufacturers of

about 250 chemicals to submit a twopage form describing their own and their

customers' activities. The data to be

submitted will permit EPA to estimate

how much of a chemical is made for

consumer versus industrial uses, how

much is lost to the environment, the

number of workers exposed during

production and processing, and the

degree of that exposure.

The rule provides the minimum

information needed to assess the risks

of human and environmental exposure

to chemicals in U.S. commerce. EPA has

chosen 250 of the approximately 55,000

chemicals in U.S. commerce for

reporting under this rule.

List of Subjects in 40 CFR Part 712:

Chemicals, Environmental Protection.

Reporting and recordkeeping

requirements.

Dated: June 7,1982.

Anne M. Gorsuch,

Administrator.

Therefore, 40 CFR Chapter I is

amended by adding a new Part 712 to

read as follows:

PART 712-CHEMICAL INFORMATION

RULES

Subpart A-General Provisions

Sec.

712.1 Scope and compliance.

712.3 Definitions.

712.5 Method of identification of substances

for reporting purposes.

712.7 " Report of readily obtainable

information for Subparts B and C.

712.15 Confidentiality.

Subpart B--Manufacturers ReportingPreliminary Assessment Information

712.20 Manufacturers and importers who

must report.

712.25 Exempt manufacturers and

importers.

712.28 Form and instructions.

712.30 Chemical lists and reporting periods.

Authority: Sec. 8(a), Toxic Substances

Control Act, Pub. L. 94-469 (90 Stat. 2003, 15

U.S.C. 2601 et seq.).

Subpart A-General Provisions

§ 712.1 Scope and compliance.

This Part establishes procedures for

chemical manufacturers and processors

to report production, use, and exposurerelated information on listed chemical

substances. Subpart A establishes

requirements that apply to all reporting

under this Part. Subparts B and C,

respectively, cover manufacturers' and

processors' reporting.

§ 712.3 Definitions.

The definitions in section 3 of TSCA,

15 U.S.C. 2602, apply for this Part. In

addition, the following definitions apply:

(a) "Byproduct" means any chemical

substance or mixture produced without

a separate commercial intent during the

manufacture, processing, use, or

disposal of another chemical substance

or mixture.

(b) "EPA" means the U.S.

Environmental Protection Agency.

(c) "Import in bulk form" means to

import a chemical substance (other than

as part of a mixture or article) in any

quantity, in cans, bottles, drums, barrels,

packages, tanks, bags, or other

containers used for purposes of

transportation or containment, if the

chemical substance has an end use or

commercial purpose separate from the

container.

(d) "Importer" means anyone who

imports a chemical substance, including

a chemical substance as part of a

mixture or article, into the customs

territory of the U.S. and includes the

person liable for the payment of any

duties on the merchandise, or an

authorized agent on his behalf. 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

withdraw merchandise in a bonded

warehouse has been transferred in

accordance with Subpart C of 19 CFR

Part 144. For the purposes of this

definition, the customs territory of the

U.S. consists of the 50 states, Puerto

Rico, and the District of Columbia.

(e) "Impurity" means a chemical

substance unintentionally present with

another chemical substance or mixture.

(f) "Intermediate" means any

chemical substance that is consumed, in

whole or in part, in chemical reactions

used for the intentional manufacture of
Federal Register / Vol. 47, No. 120 / Tuesday, June 22, 1982 / Rules and Regulations

other chemical substances or mixtures, or that is intentionally present for the

purpose of altering the rates of such

chemical reactions. (See also paragraph

(j) of this section.)

(g) "Known to or reasonably

ascertainable by" means all information

in a person's possession or control, plus

all information that a reasonable person

similarly situated might be expected to

possess, control, or know, or could

obtain without unreasonable burden.

(h) "Manufacture for commercial

purposes" means to import, produce, or

manufacture with the purpose of

obtaining an immediate or eventual

commercial advantage for the

manufacturer and includes, among other

things, such "manufacture" of any

amount of a chemical substance or

mixture:

(1) For commercial distribution,

including for test marketing.

(2) For use by the manufacturer.

including use for product research and

development, or as an intermediate.

Manufacture for commercial purposes

also applies to substances that are

produced coincidentally during the

manufacture, processing, use, or

disposal of another substance or

mixture, including 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

value. They are nonetheless produced

for the purpose of obtaining a

commercial advantage since they are

part of the manufacture of a chemical

produced for a commercial purpose.

(i) "Mixture" means any combination

of two or more chemical substances if

the combination does not occur in

nature and is not, in Whole or in part,

the result of a chemical reaction; except

that "mixture" does include (A) any

combination which occurs, in whole or

in part, as a result of a chemical reaction

if the combination could have beea

manufactured for commercial purposes

without a chemical reaction at the time

the chemical substances comprising the

combination were combined, and if all

of the chemical substances comprising

the combination are included in the

EPA, TSCA Chemical Substance

Inventory after the effective date of the

premanufacture notification requirement

under 40 CFR Part 720, and (B) hydrates

of a chemical substance or hydrated

ions formed by association of a

chemical substance with water. The

term mixture includes alloys, inorganic

glasses, ceramics, frits, and cements,

including Portland cement.

(j) "Non-isolated intermediate" means

any intermediate that is not

intentionally removed from the

equipment in which it is manufactured,

including the reaction vessel in which it

is manufactured, equipment which is

ancillary to the reaction vessel, and any

equipment through which the substance

passes during a continuous flow

process, but not including tanks or other

vessels in which the substance is stored

after its manufacture. (See also

paragraph (f) of this section.)

(k) "Owned or controlled by the

parent company" means the parent

owns or controls 50 percent or more of

the other company's voting stock or

other equity rights, or has the power to

control the management and policies of

the other company.

(1) "Person" means any natural

person, firm, company, corporation, joint

venture, 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.

(m) "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 or

mixture containing impurities is

processed for commercial purposes, then

those impurities are also processed for

commercial purposes.

(n) "Site" means a contiguous

property unit. Property divided only by a

public right-of-way shall be considered

one site. There may be more than one

manufacturing plant on a single site.

(o) "Test marketing" means

distributing in commerce a limited

amount of a chemical substance or

mixture, or article containing such

substance or mixture, to a defined

number of potential customers, during a

predetermined testing period, to explore

market capability prior to broader

distribution in commerce.

(p) "TSCA" means the Toxic

Substances Control Act, 15 U.S.C. 2601

et seq.

§ 712.5 Method of Identification of

substances for reporting purposes.

(a) Report on TSCA-reguloble

quantities. Unless specifically otherwise

required, respondents must report only

about quantities of a chemical that is

defined as a chemical substance under

TSCA section 3(2).

(b) Chemicals from natural sources. A

manufacturer of a chemical substance

which is extracted from an ore, from oil,

or from any other natural source must

report only about the manufacturing

steps for, and the uses of, that chemical,

not about production of the natural

source material or other crude

precursors derived from the natural

source material.

For example, persons who manufacture a chemical substance such as "sweetened

naphtha. 64741-87-3," but do not refine the

naphtha to produce "hexane, 110-54-3"

would not report on hexane. Only the

production of "hexane" as an isolated

product must be reported-not previous

production of more crude, complex

substances such as naphtha from which

hexane is extracted. Thus, persons who

produce crude oil, ores, and other crude

natural materials, but do not carry them

through further manufacturing steps that

produce a listed chemical have no reporting

responsibilities under this Part. Note,

however, that any method of extraction,

refinement, or purification of a listed

chemical substance is considered to be

manufacturing for the purposes of this rule.

(c) Chemical substances as marketed.

This Part requires reporting about

chemical substances as they are

marketed or used in practice. The

following preparations of a chemical

substance must be reported as the

substance itself, not as a mixture, since

these preparations are regarded as the

substance in practice.

(1) The chemical substance in aqueous

solution.

(2] The chemical substance containing

an additive (such as a stabilizer or other

chemical) to maintain the integrity or

physical form of the substance.

(3) The chemical substance in any

grade of purity.

§ 712.7 Report of readily obtainable

Information for Subparts B and C.

TSCA section 8(a) authorizes EPA to

require persons to report information

that is known to or reasonably

ascertainable by them. For purposes of

Subparts B and C, however, a lesser

standard applies. Companies must

report information tha t is readily

obtainable by management and

supervisory employees responsible for

manufacturing, processing, distributing,

technical services, and marketing.

Extensive file searches are not required.

§ 712.15 Confidentiality.

(a) Any person submitting information

under this Part may assert business

confidentiality claims for the

information as described in the pertinent

reporting form and its instructions. Any

information covered by a claim will be

disclosed by EPA only as provided in

the procedures set forth at 40 CFR Part

2.

26999
27000 Federal Register / Vol. 47, No. 120 / Tuesday,,June 22, 1982 / Rules and Regulations

(b) Persons must certify to the validity

of a claim of confidentiality they make

for information reported under this Part,

as specified on the reporting form.

(c) If no claim accompanies the

information at the time it is submitted to

EPA or if certification as to the claim is

not made on the reporting form, EPA

may place the information in an open

file available to the public without

further notice to the submitter.

Subpart B-Manufacturers

Reporting-Preliminary Assessment

Information

§ 712.20 Manufacturers and Importers

who must report.

Except as described in § 712.25, at the

time a chemical substance is listed in

§ 712.30, the following persons must

submit the "Manufacturer's ReportPreliminary Assessment Information"

(as described in § 712.28) for each plant

site at which they manufactured or

imported the chemical substance during

the reporting period specified in

§ 712.30:

(a) Persons who manufactured one or

more of the chemical substances listed

in § 712.30 for commercial purposes.

(b) Persons who imported in bulk form

one or more of the chemical substances

listed in § 712.30 for'commercial

purposes.

§ 712.25 Exempt manufacturers and

Importers.

(a) Persons who manufactured or

imported the chemical substance during

the reporting period, solely for purposes

of scientific experimentation, analysis,

or research, including research or

analysis for product development, are

not subject to reporting under § 712.20.

(b) Persons who, during the reporting

period, manufactured or imported fewer

than 500 kilograms (1100 pounds) of the

chemical substance at a single plant site

are not subject to reporting for that site

under § 712.20.

(c) Persons who qualify as small

manufacturers or importers in respect to

a specific chemical substance listed in

§ 712.30 are exempt. However, this

exemption does not apply with respect

to any chemical in § 712.30 designated

by an asterisk. A manufacturer is

qualified as small and is exempt from

submitting a report under this Subpart

for a chemical substance manufactured

at a particular plant site if both of the

following criteria are met:

(1) Total annual sales taken together

of all sites owned or controlled by the

foreign or domestic parent company

were below $30 million for the reporting

period;

(2) Total production of the listed

substance for the reporting period was

below 45,000 kilograms (100,000 pounds)

at the plant site.

(d) Persons are not subject to

reporting under § 712.20 if they

manufactured or imported the chemical

substance during the reporting period

only in the following forms:

(1) As a byproduct that was not used

or sold or that was formed as described

in 40 CFR 710.4(d) (3) through (7).

(2) As a non-isolated interimediate.

(3) As an impurity.

§ 712.28 Form and Instructions.

(a) Manufacturers and importers

subject to this Subpart must submit a

single EPA Form No. 7710-35,

"Manufacturer's Report-Preliminary

Assessment Information," for each plant

site manufacturing or importing a

chemical substance listed in § 712.30.

(b) Reporting companies may submit

their reports through individual plant

sites or company headquarters as they

choose. A separate form must be

submitted for each plant site

manufacturing the chemical substance.

(c) Forms must be sent to: Document

Control Officer, Office of Pesticides and

Toxic Substances, Environmental

Protection Agency, P.O. Box 2080,

Rockville, MD 20852.

(d) Instructions and a facsimile of the

form are as follows:

BILLING CODE 6560-50-M