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5No. 246 / Thursday, December 22, 1988 / Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 704

[OPTS-82013C; FRL-3368-1

Comprehensive Assessment

Information Rule

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is promulgating a

standard approach to gathering

information on the manufacture,

importation, and processing of chemical

substances and mixtures under section

8(a) of the Toxic Substances Control Act

(TSCA). This standard approach, or

model rule, titled the Comprehensive

Assessment Information Rule (CAIR),

establishes uniform reporting and

recordkeeping requirements and a list of

questions from which specific

information requirements will be

assembled on a substance-by-substance

basis. This rule will be used to obtain

information needed by EPA and other

Federal agencies to support the

assessment and regulation of chemical

substances and mixtures. EPA is also

establishing specific reporting

requirements for 19 substances at this

time. Future additions of substances will

be made through amendments to this

rule announced in the Federal Register.

DATES: In accordance with 40 CFR 23.5

(50 FR 7271), this rule shall be

promulgated for purposes of judicial

review at I p.m. eastern time on January

5,1989. This rule shall become effective

on February 6, 1989.

FOR FURTHER INFORMATION CONTACT.

Michael M. Stahl, Director, TSCA

Assistance Office (TS-799), Office of

Toxic Substances, Environmental

Protection Agency, Rm. EB-44, 401 M St.,

SW., Washington, DC 20460. Telephone:

(202) 554-1404. Hearing Impaired: TDD

(202) 554-0551.

SUPPLEMENTARY INFORMATION: In this

rulemaking, EPA is establishing a

standard approach to gathering

information on the manufacture,

importation, and processing of

substances. This standard approach, or

model rule, is called the Comprehensive

Assessment Information Rule (CAIR). It

establishes uniform reporting and

recordkeeping requirements that can be

adapted to specific substances and a

standardized reporting form. This rule

will reduce duplicative reporting by

industry and conserve EPA resources.

Public reporting burden for this

collection of information is presented in

chart form in Unit XII.C. of this

preamble. These estimates include time

for reviewing instructions, searching

existing data sources, gathering and

maintaining the data needed, and

completing and reviewing the collection

of information. To locate a respondent's

burden estimate on the chart, identify

the substance's Chemical Abstract

Service (CAS) Registry Number and the

respondent category for which the

report is being submitted, and locate the

corresponding range. Send comments

regarding the burden estimate or any

other aspect of this collection of

information, including suggestions for

reducing this burden, to Chief,

Information Policy Branch, PM-223, U.S.

Environmental Protection Agency, 401 M

St., SW., Washington, DC 2040; and to

the Office of Information and Regulatory

Affairs, Office of Management and

Budget, Washington, DC 20503, marked

"Attention: Desk Officer for EPA"

I. Authority

Section 8(a) of the Toxic Substances

Control Act (TSCA) authorizes the

Administrator of EPA to promulgate

rules that require manufacturers,

importers, and processors of chemical

substances and mixtures (referred to

hereafter as substances or chemical

substances) to maintain records and

submit information on such substances

as the Administrator may reasonably

require. Failure to comply fully with any

provision of a section 8(a) rule is a

violation of section 15 of TSCA and

subjects the violator to penalties under

TSCA sections 16 and 17.

II. Background

A. Proposed Rule

The proposed rule was published in

the Federal Register of October 7, 1986

(51 FR 35762). Recognizing the wide

scope of this rule and the comment

period overlap with another major

reporting rule, the Agency extended the

comment period for an additional 60

days (for a total of 150 days) to allow

sufficient time for thoughtful comment.

Extensive comments were received

from the public during this time period.

A brief discussion of these comments

and the changes made to the rule in

response to these comments is found in

each section of the preamble that

addresses that particular aspect of the

rule.

The Agency has also prepared a more

detailed discussion of the comments and

EPA responses in a document titled

"Response to Comments" that is in the

public record for this rule. Also included

in this record are the results of a pre-test

of the reporting form conducted by the

Agency during the comment period.

B. Description of Rule

The CAIR has generic reporting and

recordkeeping requirements and a

standard list of questions. The main

objective of the CAIR is to obtain

necessary information in a timely

fashion while conserving industry and

EPA resources. The CAIR will

accomplish this objective by: (1)

reducing duplicative reporting by

industry, (2) reducing familiarization

time for industry responding to reporting

requirements, and (3) reducing Agency

resources needed to develop

information-gathering rules and process

the data reported.

It is EPA's intention to amend the

CAIR from time-to-time through regular

notice and comment rulemaking for

purposes of adding substances to the

rule. Unless absolutely necessary, no

other changes will be made to the

regulatory text or the CAIR form.

Amendments will identify the

substances for which there is an

information need, the information

requested, the retrospective period

covered by the rule, and the categories

of persons who must provide the

information. Only those questions and

reporting requirements listed in the

amendments must be complied with. For

example, EPA may require

manufacturers and processors of

substance "X" to respond to all of the

questions in Section I plus questions

2.03, 3.05, and 4.05 in the reporting form,

while manufacturers and processors of

substance "Y" might be required to

answer all of the questions in Section 1

plus questions 2.03, 5.06, 7.03, and 7.05.

Hereafter, when discussing amendments

to the CAIR, the Agency is referring to

amendments that will add chemical

substances to the rule but not alter any

other parts of the regulatory text, unless

otherwise stated.

C. Intent of Rule

EPA is promulgating the CAIR as an

improved method for gathering and

maintaining information on substances

relevant to chemical risk identification,

all stages of risk assessment, and

control action functions. By using a

uniform format and set of questions,

both EPA and industry can reduce time

and resources usually associated with

the varying formats of traditional

chemical-specific rules. In the same

way, errors in reporting and

interpretations of the type of data being

requested can be reduced through

experience with a model rule. The

standardized format proposed in the

CAIR will allow EPA to have a single

data base for easy storage and retrieval,

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and will allow industry the same

benefit.

Generally, regulatory agencies gather

information to support the assessment

and management of chemical risks

through a lengthy and costly process.

First, an agency determines that a

particular substance under certain

circumstances may present a risk to

health or the environment. The agency

then gathers readily available

information about that substance to

determine possible courses of action.

This information may support a

determination that regulatory action is

appropriate, but precise information is

usually needed to determine whether

and to what degree regulation is

required. Since this information is held

by chemical substance manufacturers,

importers, and processors and is not

publicly available, the agency must use

its statutory authority to gather the

information.

This requires that the agency draft

and issue a proposed rule, review public

comments, draft and issue a final rule,

and establish and maintain a data base

on the reported information. During this

time the agency must either delay taking

risk management action or take action

without complete information. Because

each information-gathering rule usually

has unique reporting requirements, the

agency also has to respond to numerous

questions following each new rule's

promulgation.

Information-gathering rules may also

be costly to the companies submitting

the information. For each proposed rule,

potential respondents review the

requirements and, if necessary, submit

comments. Following promulgation, the

companies familiarize themselves with

the final reporting requirements, locate

the information in company files,

complete the reporting forms, and

submit them to the agency.

EPA's experience with model rules

has shown that model rules offer several

advantages for both EPA and

respondents. For EPA, the advantages

are: (1) the time to promulgate an

amendment that adds chemical

substances to a model rule is onequarter to one-third the time needed to

publish a chemical-specific rule; (2)

Agency review can concentrate on the

need for information and the

information request since reporting and

recordkeeping requirements are

standardized; (3) more efficient handling

and review of completed forms due to

standardization; and (4) a single,

universally accessible data base is

possible for storage and retrieval of

information.

For respondents, model rules offer the

advantage of certainty. No matter the

substance, many of a respondent's

reporting and recordkeeping obligations

are standardized, including the use of

the same reporting form. This reduces

familiarization time and reporting costs.

Also, EPA's experience with a model

rule has shown that as respondents

repeatedly use a form, correct errors,

and resubmit the form, significantly

fewer errors occur. Thus, with model

rules, the cost to respondents of

resubmitting reporting forms is reduced.

It also ensures that the Agency can

access a complete and accurate data

base more quickly, rather than waiting

for corrections to be made.

D. The CAIR and Other Section (a)

Model Rules

EPA designed this rule by building on

its experience with two existing section

8(a) regulations: the TSCA Inventory

Update Rule (IUR) (40 CFR Part 710,

Subpart B; 51 FR 21438; June 12, 1986)

and the Preliminary Assessment

Information Rule (PAIR) (40 CFR Part

712; 47 FR 26992; June 22,1982). The

TSCA IUR requires manufacturers and

importers of certain chemical

substances to provide EPA with basic

identification, production, and sitelimited status information every 4 years.

Questions requesting the same

information have been added to Section

1 of the CAIR reporting form and would

be answered by persons subject to the

CAIR. EPA has included an exemption

in the IUR to ensure that a company

reporting for the CAR would not have

to report for the IUR (40 CFR 710.35).

Under this exemption, persons who

must report for the CAIR are not

required to submit subsequent fUR

reports so long as the CAIR reporting

occurred no more than I year prior to

the period for which IUR reporting is

required.

The Agency also designed the CAIR

reporting form to include questions

similar to those in the PAIR. Three basic

differences exist between the PAIR and

the CAIR: (1) only manufacturers and

importers are subject to the PAIR,

whereas processors are also potentially

subject to the CARl; (2) under the PAIR,

respondents are required to answer

every question in the PAIR (EPA Form

7710-35), whereas the CAIR lists only

the specific questions (from the entire

form) that must be answered; and (3)

whereas the PAIR form contains only

basic questions on production, use, and

exposure that can support preliminary"

assessments of chemical substances, the

CAIR includes more detailed

information designed to support all'

stages of assessments.

Substances are added to the PAIR by

(1) notice and comment rulemaking or

(2) adding a substance to the rule

automatically without notice and

comment and requiring reporting within

90 days. Only substances identified by

the Interagency Testing Committee (ITC)

under TSCA section 4(e) are added

automatically.

Under the CAIR, any EPA program

office requesting basic PAIR-type

information on a substance can use the

CAIR to gather this information. Such

additions of substances will be made

through regular notice and comment

rulemaking. The Agency is planning to

amend the CAR, at some future date, to

add the ITC automatic reporting

provisions. EPA will at that time

withdraw the PAIR. However, until that

time, ITC identified substances will

continue to be added to the PAIR.

Although not issued under the

authority of TSCA section 8(a), the

Superfund Amendments and

Reauthorization Act (SARA) Title III,

section 313 rule which was published in

the Federal Register of February 16, 1988

(53 FR 4500), has some similarities to the

CAIR. Like the CAM, the SARA section

313 rule requires manufacturers,

importers, and processors to report

exposure-related information on listed

substances. Unlike the CAIR, SARA

section 313 requires annual reporting on

every substance listed in the rule unless

a substance is removed from the rule. To

minimize the burden on companies that

may have to report for both rules, EPA

has purposely staggered the reporting

periods for the first round of reporting

and will seek ways to minimize

reporting overlap in the future. Further,

any substance listed on the SARA

section 313 rule and also on the CAIR,

will not be subject to duplicative

reporting. That is, those questions on the

CAIR that directly overlap questions on

the SARA section 313 rule will not be

asked under the CAIR for any

substances that are on both rules. Data

received on those substances which are

on both rules will be shared between

EPA's Office of Toxic Substances (OTS)

and EPA's Office of Solid Waste and

Emergency Response (OSWER), as well

as EPA's Office of Air and Radiation

and Office of Water.

Also, if EPA has collected accidental

release information under the Agency's

Accidental Release Information Program

on a substance being considered for the

CAIR, questions which are duplicative

of or similar to that information will not

be asked under the CAIR. In addition,

EPA will consider whether the

information requested, if not already

available, could be gathered more

efficiently or accurately Under the

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Accidental Release Information Program

than under the CAIR.

111. The Final Rule

A. An Overview

To be consistent between other TSCA

section 8(a) rules and the CAIR, EPA

consolidated and incorporated many

requirements found in other parts of the

CFR into Part 704. Part 704 provides the

framework for all section 8(a) rules and

is amended as follows: The current

general provisions for all TSCA section

8(a) rules apply to all section 8(a)

chemical-specific rules and, unless

otherwise stated, to the CAIR. Subpart

A of Part 704 contains the general

reporting and recordkeeping provisions.

Subpart B lists chemical-specific section

8(a) rules. The regulatory text that

specifies the general provisions of the

CAIR is located in Subpart C, and

Subpart D contains the reporting period

deadlines and a matrix that lists the

substances for which there is an

information need, the information

requested for each substance, the period

covered by the rule, the persons who

must provide the information,

exemptions added or removed, and the

effective date of the final rule.

The sub-units under Unit B below

correspond to the requirements in the

CAIR matrix (Subpart D of the rule).

Each sub-unit describes a requirement in

the rule, and the last subunit explains

how these requirements are listed in the

matrix. Directions for obtaining the

CAIR reporting form and instructions

are given in Unit F.

B. Reporting Requirements

1. Who Must Report

For the 19 substances listed in this

final rule, and whenever EPA adds a

substance to the rule, the Agency states

who is required to report on each

substance (manufacturers, importers,

and/or processors) and which previous

years are covered by the rule.

Manufacturing activities are all those

activities at one site which are

necessary to produce a listed substance

and make it ready for sale or use as the

listed substance, including purifying and

importing a substance. Processing

activities, on the other hand, Include (1)

use of a listed substance after its

manufacture to make another substance

for sale or use, (2) repackaging of the

listed substance, or (3) purchasing and

preparing the listed substance for use or

distribution in commerce. Therefore,

under the CAIR, all of the steps involved

in making a CAIR listed substance,

including adding stabilizers and

additives, which are necessary to get the

substance "out the door" or ready for

use, are considered part of

manufacturing.

Persons who are required to report

must answer the CAIR reporting form

questions only for the activity that is

designated in the rule. For instance, if

EPA were to require manufacturers of a

substance to report, then a person who

both manufactures and processes the

substance would not have to answer the

CAIR questions for both activities, only

for the manufacturing activity; however,

if both were required, the company

would report on both activities using the

same form.

For some of these listed substances,

EPA is requiring processors other than

the original manufacturer or importer to

report. However, since many

manufacturers, importers, and

processors market the listed substances

to these "customers" under names other

than a systematic or easily recognizable

chemical name (i.e., the substances are

sold under trade names), persons who

buy and process the substance under a

trade name may not realize that the

substance is listed on the CAIR and that

they are required to report. Under the

CAIR, EPA considered two approaches

for gathering information from

customers who process a listed

substance. The first approach was to list

the substances in the Federal Register

by chemical name and require all

processors of certain substances to

report. Under this option, however, the

Agency would expect to receive reports

from only those persons who know or

can reasonably ascertain that they are

processing the listed substance. EPA has

therefore chosen to adopt the second

approach.

This reporting/notification

mechanism, listed in § 704.208 of the

CAIR, requires those persons who

manufacture, import, or process a listed

substance and distribute that substance

under a trade name, to do one of three

things: report for their customers who

process the listed substance; notify their

customers that the trade name

substance is listed by EPA and that the

customers must meet EPA reporting

requirements; or provide EPA with the

trade name.

Persons may report for their

customers who process a listed

substance only if they can supply the

requested information. Such reporting is

due no later than the reporting period

deadline for that substance listed in

§ 704.223(a). All reporting requirements

that apply to a customer who processes

the listed substance would then apply to

the person submitting the report on

behalf of the customer. Such persons are

liable for information they report

incorrectly on their customers' activities

just as the customers would be for

reporting incorrectly on their own

activities. Persons who sell a listed

substance under a trade name and who

are either unable to report for their

customers or who choose not to do so

are required to comply with one of the

other options.

Manufacturers, importers, or

processors may choose to notify, in

writing, their customers who are subject

to reporting and inform them of the

specific section in Subpart D that

identifies the substance and the

processor reporting requirements. The

customers who process the substance

prior to the effective date of the listing

of the substance must be notified by

certified mail no later than 30 days after

the effective date of the listing of the

substance. The customers must then

report to EPA within the time period

specified in § 704.223(b) of the receipt of

the notification. Persons who notify their

customers of their reporting obligation

must also inform them of the date such

reporting is due, and the citation of the

Federal Register that promulgated the

reporting requirements on the listed

substance.

Manufacturers, importers, or

processors who do not wish to report for

their customers or notify them of their

reporting obligations must, by I day

after the effective date of the rule listing

the substances, submit their trade

names to EPA (to the same address as

the reporting forms). These submissions

must contain, at a minimum, the

company's name and address, the

address and telephone number of the

company's technical contact, the

chemical name and CAS number of the

substance as listed in the rule, and the

trade names under which the substance

is marketed. The submitter must

indicate that the submission is in

response to a CAIR Federal Register

notice.

Once the trade names are received,

EPA will issue a technical amendment

adding the trade names to the final rule.

This amendment will be published in the

Federal Register within 4 weeks after

the rule has become effective, and the

processors of these trade name

substances would then have to submit

their reports by the deadline specified in

the reporting period for that amendment.

The following diagram graphically

depicts the reporting schedule for each

of the three customer reporting/

notification options. Since the reporting

period for the substances listed in this

final rule is 90 days from the effective

date of the final rule, the 90-day period

is used in the example. Future

amendments may have different

reporting periods.

ILLNG CODE 5SO-50-

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17

SCHEDULES FOR CUSTOMER REPORTING/NOTIFICATION OPTIONS

Persons Who Choose To Report For Their Customers:

Publication

Date

Effective

Date

------------------------------ 90 Days----------

(2) Persons Who Choose to Notify Their Customers:

Publication

Date

Effective

Date

Notify

Customers

Customers

Report

I--------------- I---30 Days---- I--90 Days ------- I

Persons Who Choose To Submit Trade Names To EPA:

Publication

Date

Submit Trade

Names

EPA Publishes

Trade Names

Customers

Report

I--Effective Date + 1 day--l--4--Weeks-- ----- 90 Days ----- I

BILLING COO 6560-50-C

(1)

Reports

Due

(3)

61701

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.In the proposed CAIR, EPA requested

comments on this customer reporting/ notification mechanism and suggestions

for alternate information gathering approaches. No substantive suggestions for an alternative mechanism were

received. Therefore, the Agency will use

the scheme as proposed. To minimize

the burden of this requirement, the

Agency has extended the time period for

notifying customers for those persons who choose this option. The proposed

rule had set a 10-day time limit; this

final rule extends the period to 30 days. EPA will reevaluate this provision and

may reduce or further extend the 30-day period for subsequent CAIR iterations.

Persons who choose the customer

notification option, but who cannot meet

the deadline, may request an extension

of time. Extension requests must be in

writing, justify the need for the

extension, and be postmarked no less

than 5 days prior to the notification

deadline.

Some commenters to the proposed

rule suggested that the definition of "customer" was too broad in that it

includes disposal facilities and persons who purchase articles.These

commenters felt that such persons should not be included under the CAIR

and that manufacturers and processors should not be responsible for notifying them or reporting for them. The Agency has decided to leave the definition as

proposed. Since persons who import or

process a listed substance as part of an

article are exempt from this rule, the

persons who sell these articles are not

responsible for notifying their customers

who process the articles.

The Agency does not agree that

persons who operate disposal facilities

should be excluded from CAIR

reporting; processing of the listed

substances at a disposal facility can

present a significant potential for

exposure about which EPA or other

agencies may require information.

2. Exemptions From Reporting

Persons who manufacture, import, or

process a listed substance are subject to

this rule unless they meet one or more of

the standard exemptions set forth in

§ § 704.5 or 704.210. The following

persons are exempt, unless the

exemption is made inapplicable on a

substance-by-substance basis: (1) small

manufacturers (total annual parent sales

are less than 40 million dollars and the

company manufactures less than 100,000 pounds at a plant site, or total annual

parent company sales less than 4 million

dollars); (2] processors and importers of

articles; (3) manufacturers, importers, and processors of substances that are

manufactured, imported, or processed

solely as impurities or byproducts; (4)

manufacturers, importers, and

processors of research and development

substances; and (5) manufacturers of

nonisolated intermediates. Whenever

EPA intends to change any or all of

these exemptions for reporting on a

particular substance, the Agency will

use notice and comment rulemaking and

the change in the exemption will be

noted in the matrix in Subpart D of the

CAIR. Two new exemptions, which are

discussed below, have been added to

§ 704.210 in Subpart C.

EPA, under the CAIR, is requiring

processors to report; however,

processors who are either small or are

solely repackagers would be exempt

from reporting. A processor is exempt if

(a) total annual parent company sales

are less than 40 million dollars and the

company processes less than 100,000

pounds of a listed substance at a plant

site; or (b) if a processor has total

annual parent company sales of less

than4 million dollars. These sales and

volume limits are the same limits EPA

uses to define small manufacturers. Like

the small manufacturer exemption, EPA

intends to revise the sales figures

periodically based on the Producer Price

Index for Chemicals and Allied

Products.

The small processor exemption uses

the same size limitations as the small

manufacturer exemption because: (1) in

the aggregate, for the chemical industry

in general, the sales and quantities

produced or processed are

approximately the same for

manufacturers and processors, and (2)

many manufacturers are also processors and therefore are potentially subject to

CAIR reporting for either or both

activities. Consistent standards for both

will result in an insignificant

information loss and will minimize

confusion for respondents. EPA is also exempting processors who

are solely repackagers. A repackager is

defined as a person who buys a listed

substance or mixture, removes the

substance or mixture from the container

in which it was bought, and transfers

this substance, as is, to another

container for sale. The Agency has

determined that requiring such reporting

would greatly expand the scope of CAIR

(i.e., the number of persons who must

report) without significantly adding to

the quality of the data reported. Persons

who engage in processing activities

other than repackaging must report.

Moreover, since repackagers, by

definition, are preparing a substance for

further use, those persons who buy the

repackaged substance and process it

further will still be required to report,

unless they are users of the substance.

Thus, EPA, in most cases, will be able to

track a. substance through commerce,

even if repackagers do not report. The

Agency will re-evaluate this exemption

in the future to determine whether it

excessively limits the reporting of

significant data.

If any of the exemptions stated above

are changed in the rule for a particular

listed substance, the Agency will

indicate this by listing the exemption

citation in the matrix and preceding it

with a minus sign (e.g., "- § 704.210").

Exemptions that are added for the first

time to the CAIR will be listed in the

matrix next to the substances to which

they apply and will be indicated by the

citation preceded with a plus sign.

3. Coverage Period

As with the other requirements

described in Unit IIL.B. of the preamble,

the dates when a company was engaged

in manufacturing, importing, or

processing a CAIR listed substance will

help determine whether the company

has to report or not. The dates must be

during a complete corporate year that

occurred during the "coverage period"

identified with each substance in

Subpart D. The coverage period is a time

span that is I day less than 2 years;

thus, no company can have more than

one complete corporate year in any one

coverage period.

An example of how the coverage

period works is as follows. EPA issues a

CAIR amendment with an effective date

of November 7, 1989; the rule requires

manufacturers of chemical A to report.

The coverge period is from November 8,

1987 to November 6, 1989. If a company

has a corporate year from January I to

December 31 and begins manufacturing

chemical.A on May 27, 1989, the

company does not have to report. Even

though the company was making the

CAIR substance during the coverage

period, no manufacturing activity

occurred during the complete corporate

fiscal year which falls within the

coverage period (January 1, 1988 to

December 31, 1988).

With each substance added to the

CAIR, EPA will identify one or more

coverage periods. When more than one

coverage period is identified with a

substance, the most recent coverage

period will be listed first, the next most

recent second, etc. The most recent

coverage period loosely corresponds to

what EPA called "current reporting" in

the proposal; the other periods were

called "past reporting." Many

commenters to the proposed rule stated

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that requiring reporting on activities that

occurred in past years (i.e., past

reporting) would be difficult for some

companies since (1) they may have gone

out of business, and (2) personnel who

were engaged in these activities and

files on these activities may no longer be

available.

EPA has decided to continue its

requirement as proposed, although in a

different format for coverage periods.

Although EPA will continue to require

reporting on some substances with past

coverage periods, persons subject to

these past requirements would only be

responsible for completing Section I of

the CAIR reporting form; however, any

question on the CAIR form may be

asked for current coverage periods.

Further, companies that were engaged in

reportable activities for more than one

coverage period, would only be required

to report for the most recent coverage

period. In addition, EPA will include no

more than two past coverage periods,

plus the current coverage period, for any

one substance, thereby minimizing the

burden on companies subject to past or

multiple coverage periods.

The Agency decided to keep some

past reporting in the CAIR since if all

such reporting were eliminated, batch

manufacturers that did not produce a

listed substance during the current

coverage period would not be required

to report, and the degree of past

exposure would be underestimated.

For the purposes of the CAIR, EPA

requires reporting only if persons

currently manufacture or process

chemical substances for commercial

purposes. Thus, companies that

manufactured or processed a listed

substance in the past, but who are not

manufacturing or processing any

chemical substances as of the effective

date of the rule or rule amendment

listing a substance, are not subject to

reporting. Companies that are subject to

the rule who engaged in reportable

activities only during a past coverage

period are to report only that

information known to them or

reasonably ascertainable by them. Thus,

some companies that cannot reconstruct

data for past reporting can state that the

data are unknown.

In the proposed rule EPA included

requirements not only for activities that

occurred in the past but also for

activities that may occur in the future.

Many comenters questioned the

Agency's ability to determine now what

its information needs will be in the

future. Further, they argued that EPA

should first review the data submitted

during the initial reporting period before

requiring subsequent reporting. The

Agency agrees. EPA will wait to propose

subsequent reporting until after initial

reporting requirements are received and

reviewed. If subsequent reporting is

deemed necessary, EPA will propose

and promulgate these requirements.

The Agency believes that waiting to

issue additional reporting requirements

until initial data have been submitted

will be beneficial to all parties. Under

the proposed approach, many years may

have elapsed between the proposal of

additional reporting requirements and

the date when actual reporting is

required, For example, some substances

in the October 7,1986, proposal had +5

designations. This means that if the

effective date for initial reporting was

October 1,1988, future reporting would

not be due until 90 days after October 1,

1993. During the period between the

proposed and final rule, new

information may become available to

the Agency or the public that might

lessen or eliminate the need for the

CAIR data.

4. Question Selection

The question selection section of the

rule specifies which questions from the

CAIR reporting from must be answered

for specific substances. Each person

subject to the rule need only answer

those questions designated for his or her

substance.

The question selection requirement

will always include Section I of the

reporting form. Other questions and

sections of the form will be requested on

an as-needed basis. These requirements

will be listed in the CAIR matrix by the

section or question number from the

CAIR reporting form. Whenever the

question selection lists a section in the

CAIR form, each person subject to that

requirement must answer all parts of

that section. A question selection listing

might be as follows: 1, 2 all, 3 all, 4.01,

4.05, 5 all. The 1, 2 all, 3 all, and 5 all,

refer to entire sections of the CAIR form;

the 4.01 and 4.05 refer to specific

questions in Section 4 of the form.

5. Reporting Period

All persons subject to the rule must

reportno later'than the dates specified

in § 704.223(a) of Subpart D of this rule,

Processors who are notified of their

reporting obligation by their chemical

suppliers must report within the time

period identified in § 704.223(b).

Persons who cannot meet a reporting

deadline can request a reasonable

extension. These requests must be in

writing with a justification for the

extension request, and they must be

received by EPA within: 30 days after

the effective date listing the substance

or 30 days after receiving notice from a

chemical supplier of the processor

reporting obligations.

Some commenters suggested that EPA

provide longer reporting periods

because the CAIR reporting period could

overlap with that of section 313 of

SARA. Since the CAIR becomes

effective after the close of the first

section 313 reporting, no overlap exists.

Other commenters requested more

time to report than the 60 days proposed

for this rule because of the resource

intensive nature of CAIR reporting. The

Agency has considered the comments

received on the length of the reporting

period and has decided to set a 90-day

response period for the substances

listed in today's rule. Since the 90-day

response period starts when the rule

becomes effective, and the rule is not

effective until 44 days after today's Federal Register publication date,

respondents will have several months to

prepare their CAIR reports. However, if

necessary, the Agency may require a

shorter response period (e.g., 60 days) in

some cases in the future. The reporting

period for each CAIR amendment will

be specified in the paragraph preceding

the CAIR matrix ( 704.223).

6. Use of the CAIR Matrix

The CAIR matrix in Subpart D of this

rule lists all of the reporting

requirements and any changes to the

standard CAIR exemptions that may

apply to each listed substance. The

matrix lists substances, persons who

must report, exemption modifications,

coverage period, questions selected for

reporting, and the effective date. The

following sample matrix was developed

to illustrate how the matrix in Subpart D

works.

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SAMPLE MATRIX

CAS No. and chemical Who must reprt Exemptions xmton de Coverage period Qluestions selectedEfetv added (+), eid usin se Effetie

name removed - date

56-78-9 ChemicalA.... M, X/P, I, P .............. 5/4/86 to 5/2/88 ..... 1, 2.01, 2.11, 2.12, 3.04, 4 all, 6.03, 5/3/88

7.01, 8.01.

............... . M ...... 5/4/85 to 5 2/87..... I ...............................................

5/3188

2-3-5 ChemicalB ....... . .................... 5/4/86 to 5/2/88 ..... 1, 2.01, 2.04 thru 2.06, 9.04 thru 5/3/88

9.07, 10.06.

M = Each Person Who Manufacturad the Substance for Commercial Purposes. I Each Person Who Imported the Substance for Commercial Purposes. P = Each Person Who Processed the Substance for Commercial Purposes. X/P = Each Person Who Manufactured, Imported, or Processed the Substance for Commercial Purposes and Distributed the Substance under a Trade Name.

As one can see from this matrix, each

of the four reporting requirements is a

colwun heading. The other column

headings are the identification for the

listed substance (CAS Number and

Chemical Name), and the effective date

of the final rule listing the substance.

The first step potential respondents

should take is to look at the chemical

list. If they have not manufactured,

imported, or processed any of the listed

substances during the previous 3

complete corporate fiscal years, they do

not have to report for the CAIR. If, on

the other hand, they have engaged in

one of those activities, they must read

further.

The first variable that excludes a

company from CAIR reporting means

that company is not subject to reporting

on that substance. For example, if a

company processes a listed substance,

but upon reading column 2 learns that

only manufacturers and importers are

required to report, that company is not

subject to reporting on that-substance.

The coverage period is the last

variable that determines whether a

company must report or not. The

company would determine the complete

corporate fiscal year which falls within

each coverage period identified in the

matrix and whether it engaged in a

subject activity during each coverage

period. The company would then report

for the most recent complete corporate

fiscal year during which it engaged in a

subject activity. If the company did not

engage in a subject activity during any

coverage period, it need not report

under the CAIR. For example, using the

sample matrix, suppose a company has

its corporate fiscal year from January 1

through December 31, and manufactured

Chemical A from August 13, 1986 to May

27,1987. The company's complete

corporate fiscal year which falls within

the coverage period (May 2, 1986-April

30, 1988) was January 1, 1987 to

December 31,1987. The company must

therefore report as a manufacturer of

Chemical A from January 1,1987 to May

27, 1987. For this activity the company is

responsible for the reporting

requirements in the next column (1, 2.01,

2.11, 2.12, etc.). Even though the

company also manufactured Chemical A

in a past coverage period (May 2, 1985 to

April 30, 1987), the company does not

need to report its activity during that

period. A company need only report for

the most recent reporting year

applicable to them.

C. Levels of Effort

In response to the many questions and

comments received on the four "levels

of effort" set forth in the proposed rule,

and a concern for lessening the burden

placed on the reporting public, EPA is

eliminating the "levels of effort"

requirement and will require persons to

report information that is "known to or

reasonably ascertainable by" them as

defined in § 704.3. The "levels of effort"

concept was conceived by the Agency to

spell out more specifically what level of

effort companies would need to meet

their reporting obligation. However,

some commenters stated that this

scheme was less clear than the "known

to or reasonably ascertainable by"

standard used in previous rules. Thus,

the latter standard has been -adopted for

this rule.

D. Recordkeeping

Under § 704.11, persons subject to the

requirements of the rule must retain: a

copy of each report submitted,

supporting materials sufficient to verify

or reconstruct the report, and a copy of

all notices sent to customers who are

required to report, with return receipt

cards. The report submitted to EPA and

its supporting material must be retained

for a period of 3 years from the date of

the submission of the report. Notices

submitted to customers, including return

receipt cards, must be retained 3 years

from the date they were sent to the

customers.

Some commenters stated that

requiring records to be kept more than 2

years would place a severe burden on

many companies. Further, the records

that must be kept, (as set forth in the

proposed rule in § 704.11(b)-"all

supporting material and documentation

used by the person to complete each

report") were viewed by the

commenters as too inclusive and

resource intensive to maintain.

EPA has reviewed the typical

schedules for compliance inspections to

determine the appropriate length of time

CAIR records must be retained so that

they will be available during an

inspection. Based on this analysis, the

Agency has determined that a period of

3 years is necessary. However, the

Agency has revised § 704.11 to specify

the retention only of those records

mentioned in the first paragraph of this

Unit.

E. Confidentiality

Section 14(a) of TSCA allows a'person

who submits information to EPA to

assert a claim of confidentiality, if

release of the information would reveal

trade secrets or confidential commercial

or financial information. Under the

CAIR, claims of confidentiality can be

asserted only at the time information is

submitted and only in the manner

specified in § 704.219. Detailed

instructions and a substantiation form

for asserting and substantiating

confidentiality claims under this rule are

contained in Appendix II of the CAIR

Form. EPA's procedures for processing

and reviewing confidentiality claims are

set forth at 40 CFR part 2, Subpart B.

Any submitter who claims

information on a submission as

confidential is required to provide two

copies of the submission: a complete

copy of the form, including all

information claimed as confidential, and

a "sanitized" copy from which all

confidential information has been

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deleted. EPA will place the submitter's

sanitized copy in the public file.

The rule requires submitters to

substantiate all confidentiality claims,

by answering questions contained in

Appendix 11 of the CAIR form. Rather

than providing a separate substantiation

for each reporting item claimed as

confidential, submitters may organize

the claimed information into categories,

(e.g., production volume or submitter

identity) and submit a single

substantiation for each category. In

addition to answering questions

pertaining to the individual categories,

submitters are required to answer

questions pertaining to all

confidentiality claims asserted.

As is detailed in the instructions in

Appendix II of the CAIR Form, each

question is claimed as confidential by

identifying the appropriate category of

confidentiality. Only those categories

identified as confidential by submitters

have to be substantiated. The

substantiation questions outline the

analytic process the submitters should

go through before asserting a claim of

confidentiality, helping the submitter to

focus on relevant issues.

Commenters have stated that this

requirement is burdensome, and that the

effort required to complete reporting

forms and the accompanying

substantiation would be laborious. EPA

recognizes the effort necessary for

reporting but does not find the burden

onerous and therefore has not altered

the requirement. EPA requires up-front

substantiation of only the six categories

of confidentiality claims rather than

separate substantiation for each and

every reporting item. This will minimize

the reporting requirement while

providing adequate substantiation.

Commenters questioned the validity

of requiring up-front substantiation of

confidentiality claims. Commenters

stated that TSCA section 14(c)L)

contains no authority for requiring upfront substantiation of confidentiality

claims. Section 14(c)[) allows

submitters to designate data as

confidential and provides for separate

submission of such data. While section

14(c)(1) does not specify substantiation,

it does provide for designation of claims

in writing and "in such manner as the

Administrator may prescribe,"

contemplating requirements involving

more than just an assertion of a claim.

EPA is committed to the public

disclosure of as much nonconfidential

information collected under the rule as

possible. Requiring up-front

substantiation of confidentiality claims

and continued close scrutiny of such

claims through the established claim

review process will ensure that as much

information as possible is releasable.

Public interest in the information

generated by this rule justifies this

approach. Up-front substantiation

obviates the need for follow-up

substantiation by submitters resulting

from EPA review or Freedom of

Information Act requests.

I If a company fails to submit a

sanitized copy of its submission, EPA

will notify the company by registered

mail. The respondent will have 30 days

from the date of receipt of the notice

letter to submit the required second

copy. If the Agency does not receive the

requested sanitized version, EPA will

place the confidential copy of the

submission in the public file on the 31st

day after the submitter'e receipt of.

EPA's letter. If no claim of

confidentiality accompanies a document

or the claim is unaccompanied by the

required substantiation at the time it is

submitted to EPA, the company will be

notified that the unsanitized copy will

be placed in the public file.

EPA will attempt to provide the public

with sufficient and informative access to

information collected under this rule

while protecting submitters' valid

proprietary interests. This will be

accomplished by: (1) disclosing to the

public all reported information not

claimed as confidential; and (2)

releasing nonconfidential aggregates of

confidential information when possible.

The proposed rule specified that the

sanitized copy of a confidential

submission provide "generic"

information for each item claimed

confidentiaL Commenters on the

proposed rule expressed concern over

the practicality of a generic information

requirement, pointing out the difficulty

of devising generic descriptions of

confidential data that would be

meaningful to the public without

revealing sensitive information. EPA

agrees that the difficulties of such

reporting are considerable and outweigh

the limited usefulness of generic

information. EPA has dropped this

requirement.

Commenters also expressed concern

over the potential for releasing

confidential business information (CBI)

when sharing information obtained

under CAIR within EPA and with other

Federal agencies. EPA's security

procedures under TSCA have

adequately protected against release of

confidential material during the

Agency's 10-year administration of

TSCA. All confidential data collected

under the rule are subject to the

requirements of the TSCA Confidential

Business Information Security Manual

and EPA's regulations at 40 CFR Part 2,

Subpart B. EPA is also working with the

participating agencies and will ensure

that proper physical and procedural

security plans are in place to protect

confidential information collected under

the rule. Also, before any transfer of CBI

material, EPA will clear any individual

who needs access to TSCA CBI

information.

The final requirements for claiming

CAIR data as CBI are summarized as

follows:

1. Make assertions for claims of

confidentiality at the time information is

submitted.

2. Sign the confidentiality certification

statement on the CAIR reporting form.

3. Provide EPA with two copies of the

submission (one complete confidential

version and one "sanitized" nonconfidential version).

4. Mark the box on each question of

the form with the appropriate letter(s)

representing the category of information

the claim is intended to protect.

5. Provide complete, detailed answers

to substantiation questions for each of

the categories of information claimed

(see step 4 above), as well as to general

questions that must be answered for all

claims.

F. The CAZI Reportn Form

EPA has compiled a comprehensive

list of questions in the CAIR reporting

form consistent with the information

types listed In TSCA section 8(a)(2).

Since many kinds of information will be

needed to support the variety of

chemical risk identification, assessment.

and control action functions of EPA and

other Federal agencies, these questions

vary in the type of information elements

and comprehensiveness. For each listed

substance, EPA will ask only those -

questions that are pertinent to planned

risk identification, assessment, or

control actions for that substance.

Persons subject to the CAIR must

answer only those questions listed for

the substance in the matrix in Subpart D

of the rule.

The reporting form is divided into 10

sections, each section containing a list

of specific questions. The form covers:

plant site information; chemical

identification; production, processing,

and importation volumes; physical/

chemical properties; environmental fate

data; economic and financial

information; manufacturing and

processing information; waste

generation and management; worker

exposure; and environmental release.

The reporting form also includes

detailed instructions including sample

answers. There are tables for converting

numeric responses to metric units, and a

glossary that defines key terms. Since

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the proposal, the Agency has clarified

some definitions and added some

others.

Section I of the form must be

completed by all respondents; the

remaining parts are to be completed as

specified in Subpart D of the rule.

Questions in Section 1 ask for basic

information, for example: plant site

classification, respondent identification,

and substance identification. Section 1

also contains questions for persons who

sell or buy trade name products and a

certification statement for persons who

had previously submitted information

requested in Subpart D.

Companies that voluntarily submit

information to EPA or other Federal

agencies are encouraged to use the

CAIR form. If the substance they are

reporting on is later added to the CAIR,

these companies may be exempt from

resubmitting the previously reported

information. The companies would still

be required to complete and submit

Section I of the CAIR reporting form.

However, the companies would be

exempt from reporting any other data

that were previously submitted,

provided: that the previously submitted

data are no more than 3 years old as of

the effective date of the substance's

addition to the rule, the data are still

complete and accurate, and a copy of

the previous submission is attached.

Persons who use this exemption must

sign the statement in Section I that

certifies that the previously reported

data meet the requirements set forth in

the exemption.

At times, CAIR may be used to require

reporting on the same substance more

than once. Some respondents may have

little or no change to report in the

second submission; these companies can

use the same exemption discussed

above for voluntary reporting. Such

respondents need only complete Section

1 of the reporting form, specify the date

of the previous submission, and certify

that the data are still complete and

accurate. This exemption will eliminate

duplicative reporting and reduce the

burden on companies subject to

reporting more than once on a listed

substance.

The Agency has revised the form

based on public comments. In general,

EPA has made the form easier to

complete by eliminating complex and

unnecessary questions, However,

questions that are likely to be asked in

the future, though not requested in this

iteration, remain on the form. The

Agency has added clarifying language to

the form to assist the respondent, and

has also revised the instructions and

glossary to add more sample answers

and definitions. CAIR forms and

instructions may be obtained by

telephoning the TSCA Assistance Office

at (202) 554-1404, or by writing to the

TSCA Assistance Office (TS-799),

Office of Toxic Substances,

Environmental Protection Agency, 401 M

St., SW., Washington, DC 20460.

Some commenters were concerned

that EPA will not have the staff to

respond to the many questions the

commenters anticipate will be asked

during the reporting period. EPA assures

the public that this will not occur.

Persons who have general questions

concerning the rule or reporting form

may call the TSCA Assistance Office at

(202) 554-1404. TDD: (202) 554-0551. The

Agency has also established a CAIR

Office staffed by persons who can

answer technical questions on the

requirements of the rule and the

reporting form. When necessary, the

TSCA Assistance Office will refer

callers to the CAIR Office. Further, the

questions of general interest asked

during this time, and EPA's responses,

will be summarized in a "Question and

Answer" document. This document will

be included with each CAIR form the

Agency sends out starting with the

second iteration of the CAIR.

IV. Substances listed in this Final Rule

Two program offices in EPA and three

other Federal agencies nominated 47

substances for the proposed rule. After

thoroughly reviewing the candidates,

two agencies have removed their

requests, and EPA has reduced its own

list of chemical candidates. The rule

now contains 19 substances. The

reasons for withdrawal of substances, a

summary of the concerns for the

remaining substances, and how the

requested information will be used

follows. The substances are listed in

Subpart D, § 704.225, of the regulatory

text. These are substances for which: (1)

the agencies know or suspect cause

adverse health or environmental effects

yet lack current exposure data; (2) the

agencies believe data gaps are

significant; and (3) the agencies place a

priority on the need for the requested

information to complete assessments of

the substances. The substances and the

offices that nominated them are listed in

Table I in this Unit of the preamble.

Additional background information on

the substances is in the public record for

this rule.

Literature searches were undertaken

for the information requested by the

offices that nominated substances for

this rule. A listing of the substances,

along with the information requests, was

sent for review to each office in EPA

and other Federal agencies participating

in the CAIR's development. These

offices searched their records for

information on the substances; however,

the searches did not provide the needed

information.

The following offices and agencies

nominated the substances included in

this final rule: EPA's Office of Air and

Radiation (OAR), EPA's Office of Toxic

Substances (OTS), and the National

Institute for Occupational Safety and

Health (NIOSH). A total of 23

nominations were made by these offices;

however, since 4 of these nominations

were multiple nominations (i.e.,

substances nominated by two offices),

19 substances are listed in this rule.

Table I of this Unit of the preamble lists

the 19 chemical substances.

The 19 substances listed in this rule

include 7 hazardous substances

regulated under the Comprehensive

Environmental Response,

Compensation, and Liability Act of 1980

(CERCLA). CERCLA requires persons

who are in charge of vessels or facilities,

to immediately notify the National

Response Center ((800) 424-8802 or (202)

426-2675) when hazardous substances

are released in quantities that are equal

to or greater than the reportable

quantities (RQs). (See CERCLA section

103 and 40 CFR Part 302; 50 FR 13456,

April 4, 1985; 51 FR 34534, September 29,

1988.) CERCLA hazardous substances

are listed in Table 302.4-List of

Hazardous Substances and Reportable

Quantities (50 FR 13475 and 51 FR

34541).

The Agency received many comments

on the Federal government's

justification for requesting reporting for

some of the substances. For the final

rule, the Agency has added additional

background material on why the

substances are listed in the rule, and

what the requesting offices intend to do

with the CAIR reported data.

The Consumer Product Safety

Commission (CPSC) nominated eight

substances for the proposed CAIR but

dropped one substance (Urea, N-(4-

chlorophenyl)-N'{(3,4-di-chlorophenyl}-.

CAS No. 101-20-2) when it was

determined that, although the substance

was on the TSCA Inventory, it presently

had no known TSCA uses and will

subsequently be removed from the

Inventory. CPSC dropped their

remaining substances because of

unexpectedly high costs to industry for

compliance with CAIR, and because

information gathered under the PAIR,

the Federal Insecticide, Fungicide, and

Rodenticide Act, and possibly, SARA,

though not as detailed as CAIR

information, will probably be sufficient

for their needs.

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The Occupational Safety and Health

Administration (OSHA) had requested

information on seven chlorinated

solvents listed in the proposed CAIR

when it was preparing a Notice of

Proposed Rulemaking for one of them,

Methylene Chloride (DCM). Because of

the length of the CAIR rulemaking

process and the current limitations on

the scope of the evolving rule. OSHA

proceeded with a survey of DCM. This

survey included questions about the

other chlorinated solvents frequently

used as substitutes for DCM. Through its

survey, OSHA compiled the material

needed for its analysis of DCM. Thus, it

has withdrawn its nomination of the

seven chlorinated solvents.

NIOSH has requested information on

one of the substances listed in the

CAIR-4,4'-Methylenebis(-2-

cbloroaniline) (MBOCA) (CAS No. 101-

14-4). MEOCA is a known animal

carcinogen. Potential for occupational

exposure exists because MBOCA is

widely used as a curing agent in the

production of cast polyurethane articles.

oTs has promulgated a chemicalspecific TSCA section 8(a) rule on

MBOCA requiring notice to EPA of the

initiation of any manufacture of MBOCA

in the U.S. However, that rule will not

provide the information NIOSH needs

concerning exposures from current uses

of imported MEOCA. All of the

questions NIOSH requested pertain to

identifying the number of workers

exposed, degree of exposure, and extent

of medical and environmental

monitoring. This information is useful to

NIOSH in identifying worker groups

suitable for epidemiologic study andtor

notification and screening programs.

The extent of MBOCA use is difficult to

characterize because not all

polyurethane manufacturing plants use

MBOCA, and those that do, use it in a

variable proportion of their products.

Although efforts have been made by

OSHA. NIOSI, and EPA to characterize

the extent of exposure to MBOCA,

estimates of numbers of workers

exposed have been very uncertain. The

degree of worker exposure at facilities

that use MBOCA in the manufacture of

polyurethane products is also difficult to

estimate because there is no centralized

data collection of environmental and

medical monitoring results.

NIOSH can use the data collected

under CAIR to identify sites for several

types of occupational health research

studies, including industrial hygiene

surveys, surveys on the efficacy of

monitoring techniques, epidemiologic

studies, and identification of sites for an

Industry-wide exposure registry. The

CAIR data will also be used in

formulating NIOSH recommendations

for limiting occupational exposure to

MBOCA. Given the potential for

continued worker exposure in the

processing of MBOCA, NIOSH believes

that an ongoing and comprehensive

assessment of worker exposure to

MBOCA is warranted.

EPA's Office of Air Quality Planning

and Standards (OAQPS) of the Office of

Air and Radiation has requested

information on five of the substances

listed in the CAIR. They are four

Toluene Diisocyanates (TDI isomers):

Benzene, 1,3-diisocyanato-2-methyl-

(CAS No. 91-08-7), Benzene, 2,4-

diisocyanato-1-methyl- (CAS No. 584-

84-9), Benzene, diisocyanatomethyl-

(CAS No. 1321-38-6), Benzene, 1,3-

diisocyanatomethyl- (CAS No. 26471-

62-5); and Chlorine (CAS No. 7782-50-

5). The TDI isomers as a group of

compounds present potential health

treats and have large production

volumes. All of the substances

nominated are volatile and can be

absorbed through the respiratory tract.

Human effects that result from exposure

to these substances can include

potential carcinogenic, teratogenic, or

mutagenic responses; extreme eye, lung,

and mucous membrane irritation; or

neurotoxic effects. The toxicity of these

substances and their high level of

production has raised conterns about

the potential for human health effects

from ambient air exposure. OAQPS

needs detailed production and exposure

information to determine whether these

substances present an actual threat to

human health.

Benzene, 1,3-diisocyanatomethyl-

(CAS No. 26471-62-5) has been

classified as a Group B2 carcinogen

based upon the EPA Guidelines for

Carcinogen Risk Assessment, September

24, 1988 (51 FR 33992). This classification

indicates that there is sufficient

evidence of carcinogenicity from animal

studies. The potential health effects,

other than cancer, associated with

exposure to.TDI isomers include

respiratory effects (irritationf

inflammation of the respiratory tract,

pulmonary hypersensitivity, lung

function decrements), dermal

sensitization, and skin and eye

irritation. The potential health effects

associated with exposure to chlorine are

eye and respiratory irritation at lower

concentrations and pulmonary edema

leading potentially to death at higher

concentrations.

The data developed through reporting

under the CAIR will be used to develop

the exposure and risk analyses for these

substances, thereby supporting,

decisions on the need to regulate these

substances under the Clean Air Act

(CAA).

OAQPS has dropped two of the

substances (ammonia and propylene

oxide) it nominated in the proposed rule

because CAA regulatory evaluations are

now essentially complete for these

substances. In addition, OAQPS has

dropped styrene because of the high

costs to industry associated with

reporting on this substance and the high

number of burden hours which would be

utilized.

OTS had requested information on 23

of the substances listed in the proposed

CAIR. The substances had been

nominated by two different divisions of

OTS. Four of the substances were also

among the group nominated by OAQPS.

The 17 substances nominated by the

Exposure Evaluation Division (ELD)

have been dropped from this final rule.

The substances fell under three

categories: (1) fertilizers widely found in

ground water, (2) volatile organic

compounds found in ground water, and

(3) some chlorinated solvents.

The fertilizers have been eliminated

from this rule because these substances

are no longer of high priority to EED.

While EED remains concerned about the

exposure potential of these substances,

the resources may not be available to

properly assess CAIR data if it were

reported.

Data on the volatile organic

compounds will probably be available

following SARA section 313 reporting. It

is likely that this information will be

sufficient to meet the needs of EED, thus

negating the need for CAIR data.

The SARA section 313 rule will also

provide data needed by EED in their

assessment of the chlorinated solvents.

Further, data submitted to the Office of

Air and Radiation under section 114 of

the CAA has provided significant

information on the major point sources

of the chlorinated solvents. In addition,

the chlorinated solvents project is

expected to be completed before the

data are expected under the CAIR.

Finally, CAIR addresses manufacturers

and processors, not the users of

substances who are of most interest to

the solvents project.

If, after the review of these alternative

sources. EED decides that additional

CAIR data are needed. EPA will review

and promulgate reporting requirements

and questions, or a subset of questions,

listed in the proposed rule.

The Existing Chemical Assessment

Division (ECAD) of OTS had nominated

18 of the oTs substances. ECAD has

decided to withdraw one chemical

substance, acid orange 7, because other

higher priority efforts precluded further

HeinOnline -- 53 Fed. Reg. 51707 1988
51708 Federal Register / Vol. 53, No. 246 / Thursday, December 22, 1988 [Rules and Regulations

work on this substance at this time. The

17 remaining substances fall within 5

groups, the first group includes

acetamide (CAS No. 60-35-5) and

Broenner's acid (CAS No. 93-00-5).

Acetamide is a known animal

carcinogen, and Broenner's acid may

contain the impurity betanaphthylamine, a known human

carcinogen. Preliminary assessments

had been conducted for both acetamide

and Broenner's acid, but too little

exposure-related information was

available to proceed with an

assessment. Human and environmental

risk is largely unknown due to the lack

of available exposure data. It is for this

reason that EPA has requested such a

broad range of information on these

substances. Should subsequent

assessments of these substances

indicate potential risks, OTS will

consider regulations to reduce identified

risks where necessary.

The second group consists of certain

substances found in human adipose

tissue. These four substances are

phenanthrene (CAS No. 85-4n-8);

ethanol, 2-chloro-, phosphate (3:1) (CAS

No. 115-96-8); pyrene (CAS No. 129-00-

0); and dimethyl disulfide (CAS No 624-

92-0). These substances have come to

the Agency's attention through the

systematic screening of chemicals

identified in human tissue samples and

other environmental media. The

widespread exposure demonstrated by

these data from the National Human

Monitoring Program, coupled with

known information on'the toxicity of

these substances, warrants investigation

of the possible sources of

contamination. Manufacture, process,

and use information needed to complete risk assessment of these substances is

not available through other sources; the

CAIR data will enable the exposure

assessment to proceed without further

delay. The exposure assessment, in turn,

is a component of the broader risk

assessment process conducted to

determine if risk reduction alternatives

need to be considered. These risk

assessment and risk management.

activities will result in some type of risk

reduction under TSCA, referral to

another Agency program office or

Federal agency, or a drop from further

consideration because of low exposure

potential, or low priority for other

reasons.

The third group consists of four

substances: hydroxylamine (CAS No.

.7803-49-8) and three of its salts (CAS

Nos. 5470-11-1,10039-54, and 10040-

00-1). The toxic properties of

hydroxylamine are documented in OTS'

Chemical Hazard Information Profile

(CHIP) document (September 11, 1984).

These include hematologic, genotoxic,

and developmental effects. Exposure

may occur during many possible uses of

hydroxylamine and its salts. The best

documented use is in color developer

solutions, but the National Occupational

Hazard Survey (NOHS) lists a wide

variety of industries with potential

hydroxylamine exposure. EPA has not

been able to document actual use or the

extent of use of hydroxylamines outside

chemical processing, photo developing,

and laboratory research. Furthermore,

the Agency has little information on the

amount of hydroxylamines in these

known uses. Concern is warranted since

the possible uses of hydroxylamines as

antioxidants, for example, could cause

widespread exposure.

The CAIR is intended to obtain

information that verifies some of these

suspected uses (or verifies that these

uses are not widespread). The CAIR will

also provide some information on

amounts and concentrations of the

hydroxylamine compounds in various

uses, and exposure data. This

information can be used to focus the

Agency's efforts on hydroxylamine uses

with highest exposures and determine

whether these uses may present an

unreasonable risk.

Preliminary risk evaluations were

conducted by ECAD on the fourth group:

semicarbazide (CAS No. 57-56-7),

semicarbazide hydrochloride (CAS No.

563-41-7), and 1,1,2,2-tetrabromoethane

[CAS No. 79-27-6). Semicarbazide and

semicarbazide hydrochloride present

carcinogenic, teratogenic, and acute

health concerns. Only limited

production, exposure, and use data are

available for these two substances. Two

manufacturers and one importer have

been identified, but these substances are

apparently produced for captive use by

a number of companies. In addition,

little Information is available on the

number of processors, their employees,

and extent of employee exposure. Three

uses have been reported, but other

potential uses have been identified.

These other uses may involve exposures

of a greater magnitude or by a different

route than those uses known to exist.

Tetrabromoethane also raises

carcinogenic health concerns in addition

to causing acute and chronic liver,

kidney, and lung effects. Until recently,

production was nearly 5 million pounds

per year, with nearly all used as a

catalyst or catalyst initiator in the

oxidation of p-xylene to produce

terephthalic acid. Production has

reportedly decreased substantially

during the last 2 years, which mitigates

the risk case. The information required

in the CAIR will confirm this change in

production needs and provide

information on the use pattern.

Risk assessments are planned for the

fifth and final group: the TDI isomers.

These are the same substances

nominated by OAQPS, and include two

individual TDI isomers and two CAS

numbers for mixed TDI isomers.

Exposure to TDI has been associated

with carcinogenic, respiratory,

immunologic, dermal, and neurologic

effects as Well as isolated reports of

hematologic and gastrointestinal

symptomology. It is apparent that the

observed effects are directly related to

the exposure concentration, length of

exposure, and the route of exposure.

OTS in coordination with OAQPS,

NIOSH, and CPSC, has substantial

concern for persons exposed to TDI in

several situations. First, persons

residing in the vicinity of TDI

manufacturing, processing, and use

facilities may be exposed to fugitive TDI

emissions. Accordingly, OAQPS is

issuing CAA section 114 letters to TDI

manufacturers to obtain emissions

information. OTS and OAQPS intend to

share these data. CAIR questions to TDI

producers that will be addressed

through CAA section 114 letters have

been withdrawn. Emissions data from

non-producers (importers and

processors) will continue to be sought

through CAIR.

Clearly the projected regulatory

endpoints, if any, for TDI cannot be

suggested until all the data are available

and analyses have been made. The

extremely broad spectrum of

applications for TDI-containing

materials mandate that EPA perform

detailed risk/benefit analyses regarding

the TDI isomers. These, of course,

require information that only industry

can provide.

The second exposure of concern to

OTS and NIOSH is occupational

exposure to TDI through processing or

use of TDI-containing materials. OTS

will be sharing these CAIR-generated

data with NIOSH. As appropriate, the

American Conference of Governmental

Industrial Hygienists (ACGIH) and

OSHA will be advised of significant

findings.

Lastly; both CPCS and oTs share

interests in consumers potentially

exposed to TDI through home use of

publicly available consumer goods

containing this diisocyanate. These

products include sealants, coatings,

adhesives, foam insulation, and

polyurethane finishes. Any information

obtained will be shared with CPSC.

The chemical list which cites the

offices that nominated the substances

follows.

HeinOnline -- 53 Fed. Reg. 51708 1988
Federal Register / Vol. 53, No. 246 / Thursday, December 22,. 1988 / Rules and Regulations '51709

TABLE I-CHEMICAL LIST

Federal = 9 [ who must repoWt Coverage period O s selected

EPA/OTS/ECAD ....................

EPA/OTS/ECAD ....................

EPA/OTS/ECAD ....................

EPA/OTS/ECAD ....................

EPA/OAR I .............................

EPA/OTS/ECAD ....................

M, X/P, I, P4

M, I

M, X/P, I, P

M, X/P, I, P

M, I

X/P, P

M, X/P, I, P

EPA/OTS/ECAD .................... I M, I

NIOSH ...................................

EPA/OTS/ECAD ....................

EPA/OTS/ECAD ....................

EPA/OTS/ECAD...................

EPA/OAR ...............................

EPA/OTS/ECAD ....................

X/P, P

M, I

M, I

M, X/P, I, P

M, I

x/P, P

M, X/P, I, P

EPA/OTS/ECAD .................. M, I

EPA/OAR ................................

EPA/OTS/ECAD ....................

EPA/OTS/EAD ....................

EPA/OAR .......................

EPA/OTS/ECAD ....................

EPA/OTS/ECAD ....... ; .......

EPA/OTS/ECAD ....................

EPA/OAR ................................

EPA/OTS/ECAD ....................

M, I

X/P. P

M, X/P, I, P

M, X/P, I, P

M

M, X/P, I, P

M, X/P, I, P

M, X/P, I. P

M,I

X/P, P

M, X/P, I, P

2/8/87-2/5/89 .................

2/8/87-2/5/89 .............

2/8/87-2/5/89 ..................

2/8/87-2/5/89 .................

2/8/87-2/5/89. ......

2/8/87-2/5/89 . ...... 2/8/87-2/5/89 ..................

2/8/87-2/5/89 .......... .......

2/8/87-2/5/89 ..................

2/8/87-2/5/89 .............

2/8/87-2/5/89 ..................

2/8/87-2/5/89 ..................

2/8/87-2/5/89 ..................

2/8/87-2/5/89 ................. 2/8/87-2/5/89 ..................

2/8/87-2/5/89 ..................

2/8/87-2/5/89 ..................

2/8/87-2/5/89 .................. 2/8/87-2/5/89 ..................

2/8/87-2/5/89 ..................

2/8/87-2/5/89 ..................

2/8/87-2/5/89 .............

2/8/87-2/5/89 ..................

2/8/87-2/5/89 .............

2/8/87-2/5/89.......

2/8/87-2/5/89 ............. 2/8/87-2/5/89 .................

Hydraz/necatboxaride (CAS No. 57-56-7) 1, 2.08, 2.12, 2.13, 9.02,

9.03, 9.08.

Acetamide (CAS No. 60-35-5) 1, 2.01, 2.04 thru 2.06, 2.08, 2.12 thin

2.14, 2.17, 3.04, 9.04 th 9.07.

Ethane 1, 1,2,2tefrabromo. (CAS No. 79-27-6) 1, 2.08, 2.12, 2.13.

Phenanthrene (CAS No. 85-01-8) 1, 2.01, 2'03, 2.05 thru 2.08, 2.11

thru 2.14, 2.16, 2.17, 9.02, 10.05, 10.06.

Benzene, 1,3-dfisocyaneto-2-me0A. (CAS No. 91-08-7)

1, 2.05 thru 2.07, 2.11, 4.01, 7.03 thru 7.08, 10.02, 10.08.

1, 2.04 thru 2.09, 2.11 thru 2.16, 3 all, 4.01 thru 4.05, 5 all, 6.05, 7.01,

7.05, 7.06, 8.01, 8.05, 8.08, 6.23, 9.01 thru 9.15, 9.19, 9.20, 9.22,

10.01, 10.02, 10.05, 10.09 thru 10.16, 10.23.

2-Naphthalenesulfonlc acid, 6-amino. (CAS No. 93-00-5) 1, 2.01,

2.04 thru 2.06, 2.08, 2.11, 2.12, 2.17, 3.04, 4.01, 9.07, 10.05, 10.06.

Benzeneamine, 4,4'-methylenebis[2-chloro- (CAS No. 101-14-4) 1,

9.01, 9.03, 9.06, 9.08, 9.12, 9.15.

Ethan, 2.choro., phosphate (3:1) (CAS No. 115-96-8) 1, 2.01, 2.03,

2.05 thru 2.08, 2.11 thru 2.14, 2.16, 2.17, 9.02, 10.05, 10.06.

Pyrene (CAS No. 129-00-0) 1, 2.01, 2.03, 2.05 thru 2.08, 2.11 hru

2.14, 2.16, 2.17, 9.02, 10.05, 10.08.

Hydrazinecarboxamde, monohydrochlorlde (CAS No. 563-41-7) 1,

2.08, 2.12, 2.13, 9.02, 9.03, 9.06.

Benzene, 2,4-ocyanato-1-mthy. (CAS No. 584-84-9)

I

1, 2.05 thru 2.07, 2.11, 4.01, 7.03 thru 7.08, 10.02, 10.08.

1, 2.04 tthu 2.09, 2.11 thru 2.16, 3 all, 4.01 thru 4.05, 5 all, 6.05, 7.01,

7.05, 7.08, 8.01, 8.05, 8.06, 8.23, 9.01 thru 9.15, 9.19, 9.20, 9.22,

10.01, 10.02, 10.05, 10.09 thru 10.16, 10.23.

DIsulfide, dYmethyl (CAS No. 624-92-0) 1, 2.01, 2.03, 2.05 thru 2.08,

2.11 thru 2.14,2.16,2.17,9.02, 10.05, 10.08.

Benzene, ditsocyanatomethyl- (CAS No. 1321-38-)

1

1, 2.05 thru 2.07, 2.11, 4.01, 7.03 thru 7.08, 10.02, 10.06, 10.08.

1, 2.04 thru 2.09, 2.11 thru 2.16, 3 all, 4.01 thru 4.05, 5 all, 6.05, 7.01,

7.05, 7.06, 8.01, 8.05, 8.08, 8.23, 9.01 thru 9.15, 9.19, 9.20, 9.22, - 10.01, 10.02, 10.05, 10.08, 10.08thrum10.16, 10.23.

Hydroxy/amne, hy&ohde (CAS No. 5470-11-1) 1, 2.07, 2.12 thru

2.14, 3.04, 6.03 thin 6.05, 9.01.

Chlorne (CAS No. 7782-50-5) 1, 2.05 thru 2.07, 2.11, 4.01, 7.03 thru

.7.08, 10.02, 10.08.

Hydroxylamne (CAS No. 7803-49-8) 1, 2.07, 2.12 thru 2.14, 3.04,

6.03 thin 6.05, 9.01.

Hydroxy/amine, sulfate (2:1) (CAS No. 10039-54-0) 1, 2.07, 2.12 thru

2.14, 3.04, 6.03 thru 6.05, 9.01.

Hydroxylamine, suffate (1:1) (CAS No. 10046-00-1) 1, 2.07, 2.12

thru 2.14, 3.04, 6.03 thru 6.05, 9.01.

Benzene ,3.dlsocyanatomethy- (CAS No. 26471-62-5)

1, 2.08 thru 2.07, 2.11, 4.01, 7.03 thru 7.06, 10.02, 10.08, 10.08.

1, 2.04 thru 2.09, 2.11 thru 2.16, 3 all, 4.01 thru 4.05, 5 all, 6.05, 7.01,

7.05, 7.08, 8.01,'8.05, 8.08, 8.23, 9.01 thru 9.15, 9.19, 9.20, 9.22,

10.01, 10.02, 10.05, 10.08, 10.09 thru 10.16, 10.23.

'EPA/OAR = Environmental Protection Agency-.Office of Air and Radiation.

EPA/OTSECAD = Environmental Protection A of Toxic Substances-Eing Chemical Assessment Division.

'NIOSH = Naional Institute for Oc Sfety a Heath. 4 M = Each Person Who Manufactured the Substance for Commerciel Purposes. I = Each Person Who Imported me Substance for Commercial Pu

P = Each Person Who Processed the Substance for Commercial =-es X/P - Each Person Who Manufactured, Imported, or Processed the Substance for Commercial Purposes and-Distributed the Substance under a Trade Name.

V. CAIR Information Management

EPA has developed a data base to

store all of the reported CAIR

information in a manner that allows

EPA to determine easily whether the

required data have already been

collected under the CAMR, to produce

reports in standard formats, and to

protect proprietary information. The

data base is an essential component of

CAIR information management. Offices

considering the development of

information-gathering rules will be able

to check the CAIR data base before

requesting the information from

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51710 . Federal Register / VoL 53, No. 246 / Thursday, December 22, 1988: Rules and Regulations

industry. This procedure will help

reduce duplicative requests, Further,

reported data will be available quickly

and in an appropriate format for the

user's review.

Commenters on the proposed rule

expressed concern about EPA's ability

to manage the quantity of data that the

CAIR will generate. EPA plans to devote

substantial resources for the

implementation of the CAIR. While the

CAIR will produce a significant amount

of data, EPA has the necessary systems

and personnel to process the volume of

data generated by the CAIR. EPA has

experience with processing large

amounts of data from the TSCA section

8(a) PAIR, and JUR reporting, and will

be able to both process CAIR data and

make it available as needed.

VI. The CAIR and Other InformationGathering Mechanisms

The comprehensive nature of the

CAIR and the reporting form allow EPA

in many instances to gather information'

for offices in EPA and other Federal

agencies. However, the CAIR is not

being promulgated as a replacement for

all other information-gathering

regulations, nor has any other office

delegated its information-gathering

authority to the CAIR. The CAIR will be

used only when it is appropriate and is

the most efficient means to gather

information. Other agencies or EPA

offices will use their own authority

under circumstances such as: (1) the

substance of interest cannot be

regulated under TSCA (e.g., the

substance is not a "chemical substance"

or "mixture" as defined in section 3 of

TSCA); (2) the information being sought

could be gathered more efficiently using

another authority; or (3) the information

being sought is more specific and

detailed than would be elicited by the

questions in the CAIR reporting form.

Therefore, while other offices within

EPA and other agencies will consider

utilizing the CAIR for informationgathering, EPA does not expect the

CAIR to be a replacement for all datagathering regulations.

VIi. Implementation of the Rule

A. The Need for Information

Prior to listing the 19 substances in

this rule, EPA searched for the requested

information to determine if the

information was already available. Each

office and agency involved in

developing the CAIR searched for this

information in their data bases and the

public literature; they were, however,

unable to locate the requested

Information listed in Subpart D of this

rule.

EPA has established a formal process whereby each office or agency that

wants to add a substance to the CA1R

must submit detailed nomination

material to oS (the nomination

material for the substances in this final

rule consist of memoranda to the public

record with relevant support

documents). The nomination must

include: why the information is needed,

how the nominating office will use the

reported data, and any other pertinent

information the Agency deems

necessary. OTS will then determine

whether the substance is a potential

candidate for the CAIR.

Substances that pass OTS' initial

screening will be submitted to an inter.

agency, government-wide workgroup for

review. As was done for the substances

in this final rule, the workgroup (made

up of representatives from program

offices in EPA and other Federal

agencies) reviews the list of substances

and information requests. If needed

information is available, the requesting

office is notified and the substance

withdrawn from the list of potential

candidates for addition to the CAIR.

Comments provided by the public on the

chemical substance nominated in a

proposed rule may also lead to the

withdrawal of the substance or revised

information requests.

-B. Budgeting for Burden

EPA has prepared an information

collection request that estimates the

reporting burden that the CAIR would

impose. The Paperwork Reduction Act

requires EPA to collect information from

the public in the least burdensome way and to summarize, for the Office of

Management and Budget's (OMB)

review, information collection activities

and their associated burden. As part of

this process, an Information Collection

Budget (ICB) is developed that estimates

the total number of burden hours the

Agency will impose on the public during

the next fiscal year.

CAIR is included in this budget

process. In June of each year, each

program office participating in CAIR

will submit an ICB profile to the

Information and Regulatory Systems

Division (IRSD) in EPA's Office of

Policy, Planning and Evaluation. This

profile will contain the estimated

number of substances on which the

program expects to request data, the

total burden hours associated with the

request, and, if possible, the names of

the substances involved. Based on this

profile, each program office will have a

CAIR line item on the ICB containing that office's total burden hours for CAIR

requests. Making each EPA office

accountable for the burden they impose

through the CAIR will ensure that they

use the rule judiciously.

For the substances listed in this final

rule, the 01'S has budgeted for the"

burden hours for its substances along

with the substances added by NIOSH.

(OAR has accounted for its own

substances.) in the future, each EPA

office that adds a substance to the CAIN

will account for the burden hours as

described above while other agencies

that add substances to CAIR will

account for the burden hours in their

own ICB.

Some commenters suggested that the

CAIR will dramatically increase the

government-wide reporting burden

placed on industry each year and, in an

effort to reduce this effect, EPA should

not continue with the CAIR. EPA does

not agree with these commenters'

conclusions regarding the increased

reporting burden. First, if EPA did not

continue with the CAIR, the burden

hours allocated for the rule would be

available elsewhere in the Agency for

use. Thus, there would be no net

difference in the burden placed on

industry by EPA If the CAIR is or is not

promulgated. Second, the Agency has

developed CAIR as an efficient

information-gathering tool that should

require less burden to comply with over

time than separate rules gathering the

same information. That is, more

information can be collected at the same

or less cost using the CAIR than using

individual information-gathering rules.

C. Assistance for Submitters

Giv6n the comprehensive nature of

some questions in the CAIR reporting

form, EPA is committed to providing

technical assistance to companies

reporting for the CAIR. Besides the

instruction document that accompanies

the reporting form, companies will be

able to contact EPA or its contractor for

assistance. An assistance office has

been established to answer questions

regarding the CAIR and will be staffed

by a team of information specialists who

are thoroughly familiar with the rule

requirements and reporting form.

For the second iteration of CAIR, the

Agency will compile and distribute a

summary of "Questions and Answers"

asked by submitters. The Agency has

also developed a brochure that explains

how the CAIR operates. Copies of this

brochure are available from the TSCA

Assistance Office.

D. Evaluation

To ensure that the CAIR meets its

objectives of providing timely, reliable,

useful, and non-duplicative data while

Imposing a minimum burden on

HeinOnline -- 53 Fed. Reg. 51710 1988
No. 246 / Thursday, December 22, 1988 / Rules and Regulations 51711

industry, EPA has and will continue to

evaluate the CAIR. The Agency has

conducted a review of the final rule

package to assure that there is adequate

documentation to justify each

information request.

The Agency has also reviewed the

effectiveness of the nominating process

in meeting the requirements of the

Paperwork Reduction Act. Since the

nomination process is standard for OTS,

this review involved all OTS ICRS,

including the CAIR. It is also the

Agency's intention to evaluate the data

submitted under the CAIR by reviewing

forms for apparent inconsistencies and

surveying submitters to determine

problem areas.

Finally, a survey of data users both

within EPA and at other agencies that

nominated listed substances will be

conducted. Interviews with a sample of

users will be conducted to assure that

the data submitted meet the needs of the

user. A special report will be prepared

that will examine any problem with

timeliness of data receipt and determine

if the levels of precision and specificity

have been met.

VIII. Public Participation

EPA believes that the public review

that occurred during the development of

this rule was important. The Agency

actively sought public input early in the

developmental stages of the rule and

met with all organizations requesting a

meeting. Two general public meetings

were held in July of 1985 to discuss an

early draft of the rule and reporting form. Constructive comments helped

EPA refine the rule to make it more

understandable and effective. After

further revisions, the CAIR reporting form was circulated again for public

review in December 1985. Again, more

constructive comments were made, and

many were adopted.

EPA issued a notice on January 24,

1986 (51 FR 3251), asking for

participation in a pretest of the reporting

form. The purpose of the pretest was

two-fold: (1) to test whether the

questions are easily understood, and (2)

to estimate the reporting burden

associated with answering questions.

The Agency had hoped many volunteers

would participate. However, fewer

applied than were expected. Therefore,

the Agency does not view the results of

this pretest as representative of the

entire industry. The pretest did,

however, provide extremely valuable

"hands-on" data that were used in

making changes to the form and for

determining the economic impact of this

rule.

After publication of the proposed rule

(51 FR 35762), EPA extended the public

comment period. The Agency

appreciates all of the comments that

have been made, and this final rule,

reflects EPAs consideration of those

comments.

IX. Alternatives Considered

Before and during the development of

the CAIR, the Agency considered three

major alternative approaches for

meeting its information-gathering

objectives: (1) issuing chemical-specific

TSCA section 8(a) rules, (2) issuing the

CAIR list of questions as guidelines for

incorporation in chemical-specific rules,

and (3) developing a three-tier approach

to reporting (of which parts of CAIR

would comprise the first two tiers). After

review of these approaches, the Agency

decided to develop the CAIR as

proposed.

Chemical-specific rules, unlike the

CAIR, can be tailored to meet very

specific needs. However, as discussed

above, these rules are costly for EPA to

establish and implement, and for

industry to respond to. If specific

information is needed that is beyond the

scope of CAIR, the Agency always has

the option of issuing a chemical-specific

rule for that substance.

A variation of the chemical-specific

option would be the issuance of the

CAIR list of questions as guidelines.

Whenever an information need arose,

questions from the guidelines could be

chosen and incorporated into a

chemical-specific rule. An advantage of

this option is that the guidelines could

be modified as necessary without notice

and comment.

The Agency has determined that such

an option would be less desirable than

issuance of a model-rule because many

of the efficiencies offered by a model

rule would be diminished or lost. There

would be a diminished incentive to use

the questions exactly as they are

written. The additional variability

industry would face with such minor

changes would impose substantial costs

to industry in responding to each

chemical-specific rule. Also, chemicalspecific rules would require substantial

additional space in the Federal Register

since the questions would have to be

stated in full rather than simply

specified by number under the CAIR.

Furthermore, there is no need to issue

CAIR questions as guidelines. Many of

the questions were taken from existing

government forms previously used to

collect information from industry. There

has also been much cooperation with

industry representatives in developing

the form so that the questions will both

provide the information needed to EPA

and be in the terminology used by

industry. EPA does not anticipate that a

major refinement of the questions will

be necessary after promulgation of this

final rule. Moreover, should the need

arise, EPA can develop a TSCA section

8(a) chemical-specific rule with

questions tailored to the unique

characteristics of the requesters.

The last option that many commenters

suggested was that EPA consider

gathering information according to the

stage of assessment of a substance. That

is, for substances in the early stages of

assessment, request only basic

information like that found in the PAIR.

If, following analysis of the reported

data, the Agency finds that additional

information is needed, a more detailed

substance-specific rule would be used.

EPA does not believe a tiered

reporting approach is necessary or

appropriate; in fact, such a reporting

scheme could be counterproductive

since it could involve two or three

separate complete rulemakings that

would be costly to EPA in terms of

Agency resources and delays in

obtaining the needed information.

Whereas a tiered reporting approach

might be feasible if the CAIR was solely

an OTS rule, the applicability of the

CAIR to other program offices within

EPA other than OTS, as well as to other

Federal agencies, makes a tiered

reporting approach impractical. The

broad range of topics covered by the

CAIR is one of the primary benefits

derived from the rule. An office or

agency can choose specific questions on

the CAIR according to its particular

stage of assessment.

X. Economic Analysis

A. Methodology

EPA has conducted in-depth studies to

estimate the amount of secretarial,

technical, and managerial time needed

to respond to each question in the

reporting form. These studies are

located in the public record for this

rulemaking.

The response times were derived from

three major sources. One source was the

set of Federal personnel experienced in

preparing questionnaires that contained

questions similar to those in the

reporting form. Another source was

Federal agency documents that

described and analyzed questionnaires

that contained questions similar to those

in the reporting form. The last source

was persons in private industry and

industry research organizations who

performed surveys with questionnaires

similar to the CAIR form. These persons

provided estimates of the time required

to respond to certain parts of the

reporting form. The Agency also used a

Federal Register / Vol. 53,

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51712 Federal Register / Vol. 53, No. 246 / Thursday, December 22, 1988 / Rules and Regulations

pretest of the CAIR form to determine

the time required to complete various

questions on the reporting form.

The question-specific reporting

burden was estimated for each of three

distinct labor categories: managerial,

technical, and secretarial. Mean

reporting times and variances were then

calculated for each labor category.

Applicable wage rates were then

multiplied by the time estimates and the

results were summed to establish the

estimated reporting cost per question.

Combining the cost per question for all

the questions required of each type of

respondent yielded both a mean

reporting cost and a 90-percent

confidence level cost range. This

procedure was followed for each

chemical substance listed in Subpart D.

The mean reporting costs (i.e.. unit

costs) were further multiplied by the

estimated number of respondents for

each substance to determine the direct

reporting cost of the rule.

EPA used the 1987 update of the

TSCA Inventory data base as its

primary source of plant sites that

manufacture and/or import CAIR-listed

substances. This provided the latest site

counts for all CAIR substances except

chlorine. (Chlorine, an inorganic

chemical, was not included in the

Inventory update.) Additional data

sources were consulted to establish site

count estimates for chlorine and to

double-check estimates for the

remaining CAIR substances. The

Agency reviewed the following sources,

among others: Chemical Economics

Handbook, Directory of Chemical

Producers, Importers of Benzenoid

Chemicals and Products, Synthetic

Organic Chemicals, Chemical Products

Synopsis, Million Dollar Directory

Market Identifiers, and the Census

Bureau's Census of Manufacturers.

Articles from recent trade magazines

and journals, as well as contacts with a

variety of industry personnel, were also

used to identify plant sites.

To identify the plants that process the

substances, data were collected on the

downstream uses of each listed

substance for which processor reporting

is required. All those facilities that were

strictly end users of listed substances

were not considered to be processors for

this rule.

The final step associated with

developing the site estimates was to

determine the number of "unique sites";

that is, those sites that must report.

Since a site with multiple processes may

be required to report for more than one

substance, it is most important not to

count that site more than once.

Adjustments of site estimates were

based on an examination of the specific

identities and chemical operations of

expected submitters.

Once site estimates were established,

estimating a per substance cost for each

respondent type was then a simple

matter. The estimated number of sites

per respondent category was multiplied

by the appropriate estimated reporting

cost per substance. In turn, the reporting

costs per substance were summed to

provide the total direct reporting cost of

the rule.

Reporting sites also incur a variety of

indirect reporting costs. These involve

such activities as familiarization with

the rule and its reporting requirements,

the establishment and maintenance of a

recordkeeping system, notifying EPA

and/or customers of any trade names,

the cost of substantiating any

information claimed to be confidential,

and the miscellaneous costs associated

with reviewing, copying, and mailing the

completed CAIR reporting form. In each

case, research was conducted to

determine the appropriate unit cost (per

report or per site) of each indirect cost

category. (Two sets of unit costs were

established in this analysis, one for a

respondent answering a large number of

questions and the other for a respondent

answering a small number of questions.)

After unit costs were multiplied by the

appropriate number of sites and reports,

the results were summed to produce the

total indirect reporting cost of the rule.

The final step in determining the total

cost of the rule was to estimate the cost

incurred by firms that must assess

whether they are required to report.

Two steps were required to calculate

this compliance determination cost. The

first step was to identify the number of

sites that are exempt from reporting

requirements. The second step was to

estimate the cost of making a

compliance determination.

Those sites that do not manufacture,

import, or process a listed substance are

obviously not covered by the CAIR. The

same is true of those sites that only use

a CAIR substance. While keeping these

points in mind, the list of CAIR

substances was reviewed to determine

the set of Standard Industrial

Classification (SIC) codes likely to

contain the sites subject to CAIR

reporting or be exempt from reporting.

The establishment counts in SIC 28, 29,

516, 2295, 2515, 3069, 3086, and 5198 were

tallied, and the sum was then reduced

by the number of sites listed as small

businesses having annual sales under $4

million. (These sites are also exempt

from CAIR reporting requirements.) The

adjusted sum was further reduced by

the estimated number of sites that

would report in the initial reporting

period. A total of 14,855 exempt sites

was ultimately established.

The second step was to estimate the

unit cost of compliance determination. A

variety of industry and Agency sources

were consulted to establish a range of

time (required by labor category)

needed to determine that reporting is

not required. The time estimates were

then multiplied by appropriate labor

rates to provide a range of compliance

determination costs. A unit cost of $33

per site was selected from the range

after it was determined to be most

applicable. (It was necessary to allocate

to the form familiarization cost category

the compliance determination cost

incurred by a site that must report under

the CAIR. Since the review of reporting

requirements that makes up a

compliance determination is also a

necessary part of form familiarization.

this allocation was done to prevent

double counting of costs.) The exempt

,site count was then multiplied by the

unit cost of compliance determination to

provide the final cost component of the

CAIR.

Performing the set of calculations

described above yields an estimated

total cost for the 19 currently listed

substances of $2.3 million. These costs

are broken down into direct reporting

costs, indirect reporting costs, and

compliance determination costs. The

total direct reporting cost is estimated to

be $1.23 million. The total indirect

reporting cost is estimated to be

$560,788. The total compliance

determination cost is estimated to be

$490,215 for the 14,855 sites exempted

from reporting requirements.

Based on the information collection

requirements in this rule and the set of

CAIR listed substances, the Agency

calculated the expected costs of a

typical responding site that would incur

all possible costs. (Not all sites will

incur such costs as CBI substantiation

and trade name notification, Moreover,

these expected costs are averages and

may not actually match the cost of a

specific site. Thus, the costs presented

below will be somewhat different from

those derived by dividing total line item

costs by the number of responding sites

or supplied reports.)

per report.

150 hours to gather and report the

requested information ......................... $5,092

17 houra to substantiate CBI claims ........... $

8 hours to conduct trade name

notification .... .............. $360

11 hours to establish and file the

records that support a reporting

.effort .............. $38

1.5 hours to incur miscellaneous costs

(m ailing, etc.) .............................................. $70

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per site:

43 hours for rule and form

familiarization ..................... $1,490

EPA assumes thai the per site costs

will be incurred one-time only for those

respondents that submit two or more

reports per site in any given reporting

year. Only the per report costs will be

incurred for each report submitted by a

responding site. EPA further assumes

that sites which must report in a

following year will incur only a portion

of the initial reporting year's per site

costs. This Is due to the expected

increase in rule familiarization and

understanding as the reports are

prepared over a period of time. This may

in fact not be entirely true in those cases

in which a respondent must answer a

small number of questions and, as a

result, may not learn the entire reporting

form.

8. EPA Administrative Costs

EPA will incur a variety of costs to

process and maintain the information

provided under the CAIR. This section

briefly describes the costs associated

with the Agency's administration of this

rule.

EPA has developed a system to

process and maintain the CAIR

information. The major tasks in this

overall effort are performing a feasibility

study, and developing a data entry

system, data base system, and tracking

system. The initial system design and

development costs are estimated to be

$445,000. There will be an additional

cost of $65,00Y for the development of

standardized reports for CAIR data

users.

EPA also expects to incur costsassociated with entering and processing

data for the initial 19 chemicals,

administrating the CAIR information

office, and several other projects. These

activities are estimated to cost $444,000.

In addition to the costs shown above,

EPA will incur staff costs for these rulerelated activities. Approximately 5.4

full-time equivalents (FTEs) will be

required in the implementation of the

initial CAIR. At $32,000 per FrE, the

total of 5.4 FTEs will cost EPA $172,800.

Thus, it is assumed that EPA's

expenditures for the development and

implementation of this final rule will be

roughly $954,750 plus a total of $172,800

in staff costs. This yields a total cost to

EPA of $1,127,550.

C. Response to Comments on Economic

Analysis

A variety of comments were received

on the proposed CAIR. Among these

comments were a set that specifically

addressed cost estimates. In general,

these comments all argued that EPA's

cost estimate was considerably below

the cost industry officials believed

would be incurred. Listed below are the

major comments addressing economic

issues and the EPA response. More

detailed responses can be found in the

rulemaking record.

A number of commenters stated that

the unit labor rates EPA used were far

below the levels found in industry

today. It was argued that hourly wages

were too low and that labor overhead

should also be included in cost

estimates. It was also argued that the

use of only three labor categories

(managerial, technical, and clerical)

tended to bias downward the'

cumulative cost of the work performed

by all the different types of personnel

involved in filling out the CAIR

reporting form.

The Agency agrees with these general

comments and has taken two major

steps to address the concerns. First, EPA

factored inflation levels since March

1984 into the set of wage rates used to

cost out the proposed CAIR. The unit

labor costs were based on March 1984

data and, therefore, needed to be

updated. Second, the Agency realized

that industry responses to government

health and environmental reporting

requirements tend to be prepared by

senior level personnel from a variety of

backgrounds (financial, legal, and

operational). Thus, the Agency used

different and more senior labor cost

categories from Bureau of Labor

Statistics data in establishing the new

unit labor rates for the economic

analysis. These two major adjustments

resulted in hourly wage rate increases of

27.3, 35.3, and 11.2 percent for

managerial, technical, and clerical

personnel, respectively.

The Agency does not agree that labor

overhead should be factored into the

cost estimates. The allocation of any

overhead expenses to CAIR reporting

activities is an arbitrary exercise. This is

especially true because the indirect

reporting costs that might be classified

as overhead are addressed as separate

line items in the cost estimates prepared

for the final rule. As an illustration, the

indirect reporting costs associated with

the establishment of a support document

recordkeeping system are now shown as

a distinct line item in the economic

analysis. Other commenters argued that EPA

underestimated the total number of

chemical processors that might be

subject to reporting requirements, and

thereby further underestimated the

possible total cost of the rule. As an

illustration, it was argued that the count

used by EPA for the number of ammonia

processors and solvent processors was

too low. Commenters also argued that

EPA's site counts for non-sample

substances were low in some cases.

The Agency agrees with these

comments in general. The Agency chose

a group of sample substances to be

representative, in terms of

manufacturing operations, of the set of

substances currently listed on the CAIR.

The Agency conducted a comparison of

the sample and non-sample substances

and determined that the samples are

representative of the total set in terms of

chemical type, annual production

volume, and the number of

manufacturing sites.

The analysis prepared for the

proposed CAIR estimated a total of

roughly 298,000 processing sites for the

15 sample substances. Follow-up work

using additional primary and secondary

data sources resulted in an increase in

the count of processing sites to roughly

308,700 sites. With respect to the site

counts for the non-sample substances,

these estimates were derived from the

data collected on the sample

substances. Thus, they were only to be

representative, not specific. The

adjustments made to the site counts for

the sample substances should result in

more accurate site counts for nonsample substances.

Some commenters believed that EPA

underestimated the time and effort

required to complete the CAIR reporting

form. They argued that far more time

would be required to collect data from

scattered squrces, to coordinate form

analysis and response efforts between

different personnel, and to actually

develop responses to various questions

on the form. With respect to this last

issue, commenters argued that EPA

failed to account for the additional

reporting burden incurred by firms that

do multiple processing of CAiR

substances, have multiple work areas, or

have multiple emission points. It was

also argued that these firms would

ostensibly be required to provide

multiple responses to various questions

on the reporting form.

The Agency agrees with these points.

As a result, additional cost line items

were added to account for the activities

that had not been considered in the

proposed rule's economic analysis. The

new cost line items are compliance

determination, review and mailing of the

final reporting form, collection and

calculation of data required by CAIR

form questions, and several other

miscellaneous costs associated with

form preparation. In addition, revisions

were made to the estimated costs for

CBI substantiation, form familiarization,

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51714 Federal Register / Vol. 53, No. 246 / Thursday, December 22, 1988 / Rules and Regulations

recordkeeping, and trade name

notification. The result of these changes,

plus the revised site counts and unit

labor rates mentioned above, was an

increase in the estimated total cost from

$3.27 million to roughly $23.9 million.

However, this cost was then reduced

significantly by factoring in the

exemptions used in the final rule and by

the change in the number of substances

on the rule from 47 for the proposed rule

to 19 for this final rule.

XI. Rulemaking Record

The following documents constitute

the major documents in the record for

this rule (docket control number OPTS82013C). All documents, including the

index to the complete record, are

available to the public in the TSCA

Public Docket Office from 8 a.m. to 4

p.m., Monday through Friday, excluding

legal holidays. The TSCA Public Docket

Office is located at EPA Headquarters,

Rm. NE-G004, 401 M Street, SW.,

Washington, DC 20460. The record

includes but is not limited to the

following information:

1. Federal Register Notices: (April 4,

1985; 50 FR 13391), (June 17,1985; 50 FR

25095), (January 24,1986; 51 FR 3251),

(February 28,1986; 51 FR 7120), and

(December 19, 1986; 51 FR 45486).

2. Transcript of public meeting held on

July 17,1985.

3. Transcript of public meeting held on

July 30, 1985.

4. Minutes of meetings held with the

Chemical Manufacturers Association,

the Synthetic Organic Chemical

Manufacturers Association, and the

American Petroleum Institute.

5. Copy of memorandum and CAIR

reporting form circulated to the public

for review on December 9,1985.

6. CAIR reporting form response times

and labor costs analysis, Centaur

Associates, April 21, 1986.

7. Economic analysis of the CAIR.

8. Comments received on earlier

drafts of the CAIR preamble and

reporting form.

9. Background information on

substances appearing in the proposed

and final rule.

10. Proposed Rule October 7,1988; 51

FR 35762.

11. "Comments received on the

proposed rule.

12. CAIR Pretest Summary Report,

Science Applications International

Corporation, March 20, 1987.

13. Correspondence with and from the

public regarding CAIR.

14. Minutes of meeting held with

Industry, environmental, and labor

organizations on February 26,1986.

15. Minutes of meeting with

representatives from the Chemical

Manufacturers Association, the Office of

Management and Budget, and the

Environmental Protection Agency held

on August 6, 1987.

16. Response to Comment document.

17. Final CAIR Reporting Form and

Instructions.

XII. REGULATORY ASSESSMENT

REQUIREMENTS

A. Executive Order 12291

Under Executive Order 12291, EPA

must judge whether a rule is "major"

and therefore requires a Regulatory

Impact Analysis. The Agency has,

determined that this final rule is not "major" because it does not have an

effect of $100 million or more on the

economy. EPA also anticipates that this

rule will not have a significant effect on

competition, costs, or prices. This rule

was submitted to the OMB for review as

required by Executive Order 12291.

B. Regulatory Flexibility Act

Under the Regulatory Flexibility Act, 5

U.S.C. 605(b), EPA certifies that this rule

will not have a significant impact on a

substantial number of small businesses.

Small businesses are defined in this rule

and are exempt from reporting except

under certain circumstances defined in

TSCA.

C. Paperwork Reduction Act

The information collection

requirements in this rule were submitted

for approval to the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1980, 44

U.S.C. 3501 et seq. and have been

assigned OMB control number 2010-

0019.

Public reporting burden for this

collection of information is estimated to

vary as presented in the following chart.

These estimates include time for

reviewing instructions, searching

existing data sources, gathering and

maintaining the data needed, and

completing and reviewing the collection

of information. To locate a respondent's

burden estimate on the chart, identify

the substance's CAS number and the

respondent category for which the

report is being submitted, and locate the

corresponding range. Send comments

regarding the burden estimate or any

other aspect of this collection of

information, including suggestions for

reducing this burden, to Chief,

Information Policy Branch, PM-223, U.S.

Environmental Protection Agency, 401 M

Street, SW., Washington, DC 20460; and

to the Office of Information and

Regulatory Affairs, Office of

Management and Budget, Washington,

DC 20503, marked "Attention: Desk

Officer for EPA."

CAIR REPORTING BURDEN FOR BOTH QUESTION-SPECIFIC AND GENERAL COSTS (RANGE IN HOURS)

Oiem~~caI I II M nacturer I Importer/ Chemical name CAS No. Manufacter 4 . Importer P roces processor re/ processor m

orazneCaa.Xamloe ........................................ Ethane, 1,1,2.2-tetrabromo- ......................................

57-6-7...

60-35-6 .........

7274-6.

Pr"Urnaww rw ............. ................ . ........................ 85-0!-8 ......... Benzene, 1,3.disocyanato-2-methy .................. ...... . 91-08-7 ......... 2-Naphthalenesulfonic acid, 6-amino .......... 93-00-5.

Benzeneamine, 4,4-methyee l ................. 101-14-4.....

Ethanol, 2.chloro-, phosphate (3:1) ......... ................. ....... 118-9-8 ....... Pyrene ................... ..... ......... .... . 129-00-0.....

Hydrazinecarboxamide, r.onohydrochod.d.... 563-41-7.

Benzene, Z4-disocyanato-1-methyl- ..................... Disutfide, lirnethyl .................... ..... .................... .. . ............. ..... 24-92..0.-....

dilsocyanatomethyl .... ............................ .. .................

Hyoroxytamine, hydochlore .....................

Clodrine... .a.. ....... ,. ......... ...................

Hydroxylamlne, sulfate (2:1)..

Hydr0 xytamlne, sulfate (1:1).

1321-38-6 .....

5470-11-1.

7782-50-5.

7803-49-8.....

10039-54-0...

10046-00-1-

39-47

45-57

37-41

40-47

194-231

44-54

NA

40-47

40-47

39-47

194-231

40-47

19-233

37-42

5-79

37-42

37-42

37-42

39-47

45-57

37-41'

40-46

98-114

44-54

NA

40-46

40-46

39-47

98-114

40-46

100-116

38-43

NA

38-43

38-43

38-43

'41-49

NA

37-41

40-48

268-316

NA

47-60

NA

NA

41-49

268-316

NA

270-320

38-43

NA

38-43

38-43

38-43

44-56

61-79

37-42

44-54

403-466

55-72

55-72

44-54

44-54

44-56

403-466

44-54

407-471

39-44

91-128

39-44

39-44

39-44

Benzene,

41-50

51-65

37-41

41-49

266-315

48-61

47-60

41-49

41-49

41-50

268-315

41-49

269-318

38-43

NA

38-43

38-43

38-43 °°,o . o.. .......- o. .. ° . , ............. ,....

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CAIR REPORTING BURDEN FOR BMT QUESTION-SPECIFIC AND GENERAL COSM (RANGE INJ-(OIRS)-Conflnued

Chemical name

Benzene, 1,1.-disocyanatomethyl-. ................. ....................

List of Subjects in 40 CFR Part 704

Chemicals, Environmental protection,

Hazardous materials, Reporting and

recordkeeping requirements.

Dated: October 27,1988.

Lee M. Thomas,

Administrator.

Therefore, 40 CFR Part.704 is

amended as follows:

1. The authority citation for Part 704

continues to read as follows:

Authority: 15 U.S.C. 2607(a).

PART 704-REPORTING AND

RECORDKEEPING REQUIREMENTS

2. By revising the Part heading to read

as set forth above.

Subpart A-General Reporting and

Recordkeeping Provisions for Section

8(a) Information-Gathering Rules

3. By revising the Subpart A heading

to read as set forth above.

4. By revising I § 704.1, 704,3, and 704.5

to read as follows:

§ 704.1 Scope.

(a) This Part specifies reporting and

recordkeeping procedures under section

8(a) of the Toxic Substances Control Act

(TSCA) for manufacturers, importers,

and processors of chemical substances

and mixtures (hereafter collectively

referred to as substances) that are

identified in Subpart B or D of this Part.

The reporting and recordkeeping

provisions in Subpart A of this Part

apply throughout this Part unless

revised in any other subpart.

(b) Subpart B of this Part sets out

chemical-specific reporting and

recordkeeping requirements under

section 8(a) of TSCA.

(c] Subpart C of this Part sets out the

general reporting provisions for the

Comprehensive Assessment Information

Rule (CAIR). CAIR standardizes certain

section 8(a) rules by: providing a set of

uniform questions for EPA and other

agencies to use in assembling specific

reporting requirements; requiring the

submission of information on a standard

reporting form; and establishing uniform

reporting and recordkeeping provisions

that supplement the reporting and

recordkeeping provisions in Subpart A

of this Part. CAIR provisions apply only

to those persons who manufacture,

CAS No. Manufacturer

.2"471-62-6.. 196-233

import, or process a substance identified

in Subpart D of this Part during the time

period for which reporting Is required.

(d) Subpart D of this Part contains a

matrix that identifies the substances for

which EPA requires reporting under

Subpart C. the persons who must report

the information to EPA, the information

that must be reported, the coverage

period (as that term is defined in

§ 704.203), and the effective date of the

final rule.

§ 704.3 Definitions.

All definitions as set forth in section 3

of TSCA apply in this Part. In addition,

the following definitions are provided

for the purposes of this Part.

"Annual" means the corporate fiscal

year.

"Article" means a manufactured item

(1) which is formed to a specific shape

or design during manufacture, (2) which

has end use function(s) dependent in

whole or in part upon its shape or design

during end use, and (3) which has either"

no change of chemical composition

during its end use or only those changes

of composition which have no

commercial purpose separate from that

of the article, and that result from a

chemical reaction that occurs upon end

use of other chemical substances,

mixtures, or articles; except that fluids

and particles are not considered articles

regardless of shape or design.

"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).

"CAS Number" means Chemical

Abstracts Service Registry Number.

"Coproduct" means a chemical

substance produced for a commercial

purpose during the manufacture,

processing, use, or disposal of another

chemical substance or mixture.

"Customer" means any person to

whom a manufacturer, importer, or

processor directly distributes any

quantity of a chemical substance.

mixture, mixture containing the

substance or mixture, or article

containing the substance or mixture,

whether or not a sale is involved.

"Domestic" means within the

geographical boundaries of the'50

United States, including the District of - Columbia. the Commonwealth .of Puerto

Importer Processor

100-116 270-32

Rico, the Virgin Islands, Guam,

American Samoa, the Northern-Mariana

Islands, and any other territory or

possession of the United States.

"Enclosed process" means a

manufacturing or processing operation

that is designed and operated so that

there is no intentional release into the

environment of any substance present in

the operation. An operation with

fugitive, inadvertent, or emergency

pressure relief releases remains an

enclosed process so long as measures

are taken to prevent worker exposure to

and environmental contamination from

the releases,

"EPA" means the United States

Environmental Protection Agency.

"Import" means to import for

commercial purposes.

"Import for commercial purposes"

means to import with the purpose of

obtaining an immediate or eventual

commercial advantage for the importer,

and includes the importation of any

amount of a chemical substance or

mixture. If a chemical substance or

mixture containing impurities is

imported for commercial purposes, then

those impurities also are imported for

commercial purposes.

"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, if the chemical substance is

intended to be removed from the

container and the substance has an end

use or commercial purpose separate

from the container.

"Importer" means (1) any person who

imports any chemical substance or any

chemical substance as part of a mixture

or article into the customs territory of

the United States, and includes:

(i) The person primarily liable for the

payment of any duties on the

merchandise, or

(ii) An authorized agent acting on his

behalf (as defined in 19 CFR 1.11).

12) Importer also includes, as

appropriate:.

(i) The consignee.

(ii) The importer of record.

(iii) The actual owner if an actual

owner's declaration and superseding

bond have been filed in accordance with

19 CFR 141.20.

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(iv) The transferee, if the right to draw

merchandise in a bonded warehouse has

been transferred in accordance with

Subpart C of 19 CFR Part 144.

(3) For the purposes of this definition,

the customs territory of the United

States consists of the 50 States, Puerto

Rico, and the District of Columbia.

"Impurity" means a chemical

substance which is unintentionally

present with another chemical

substance.

"Intermediate" means any chemical

substance that is consumed, in whole or

in part, in chemical reactions used for

the intentional manufacture of other

chemical substances or mixtures, or that

is intentionally present for the purpose

of altering the rates of such chemical

reactions.

"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.

"Manufacture" means to manufacture

for commercial purposes. . "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) 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 both byproducts that

are separated from that other substance

or mixture and impurities that remain in

that substance or mixture. Such

byproducts and impurities may, or 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

product for a commercial purpose.

"Manufacturer" means a person who

imports, produces, or manufactures a

chemical substance. A person who

extracts a component chemical

substance from a previously existing chemical substance or a complex

combination of substances is a

manufacturer of that component

chemical substance.

"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. Mechanical or

gravity transfer through a closed system

Is not considered to be intentional

removal, but storage or transfer to

shipping containers "isolates" the

substance by removing it from process

equipment in which It is manufactured.

"Own or control" means ownership of

50 percent or more of a company's voting stock or other equity rights, or the

power to control the management and

policies of that company. A company

may own or control one or more sites. A

company may be owned or controlled

by a foreign or domestic parent

company.

"Parent company" is a company that

owns or controls another company.

"Person" includes any individual,

firm, company, corporation, joint

venture, partnership, sole proprietorship, association, or any other business

entitr; any State or political subdivision

thereof; any municipality; any interstate

body; and any department, agency, or

instrumentality of the Federal

Government.

"Possession or control" means in the

possession or control of any person, or

of any subsidiary, partnership in which

the person is a general partner, parent

company, or any company or

partnership which the parent company

owns or controls, if the subsidiary,

parent company, or other company or

partnership is associated with the

person in the research, development,

test marketing, or commercial marketing

of the substance in question.

Information is in the possession or

control of a person if it is:

(1) In the person's own files including files maintained by employees of the

person in the course of their

employment.

(2) In commercially available data

bases to which the person has

purchased access.

(3) Maintained in the files in the

course of employment by other agents of

the person who are associated with

research, development, test marketing,

or commercial marketing of the chemical

substance in question.

"Process" means to process for

commercial purposes. "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 in this definition.

If a chemical substance or mixture

containing impurities is processed for

commercial purposes, then the

impurities also are processed for

commercial purposes.

"Processor" means any person who

processes a chemical substance or

mixture.

"Production volume" means the

quantity of a substance which is

produced by a manufacturer, as

measured in kilograms or pounds.

"Propose to manufacture, import, or

process" means that a person has made

a firm management decision to commit

financial resources for the manufacture,

mport, or processing of a specified chemical substance or mixture.

"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 plant

on a single site. The site fora person who imports a substance is the site of

the operating unit within the person's organization which is directly responsible for importing the substance

and which controls the import transaction and may in some cases be

the organization's headquarters office in

the United States.

"-Small manufacturer or importer"

means a manufacturer or importer that

meets either of the following standards:

(1) First standard. A manufacturer or

importer of a substance is small if its

total annual sales, when combined with

those of its parent company (if any), are

less than $40 million. However, if the

annual production or importation volume of a particular substance at any individual site owned or controlled by the manufacturer or importer is greater than 45,400 kilograms (100,000 pounds), the manufacturer or importer shall not

qualify as small for purposes of

reporting on the production or

importation of that substance at that

site, unless the manufacturer or importer qualifies as small under standard (2) of

this definition.

(2) Second standard. A manufacturer

or importer of a substance is small if its

total annual sales, when combined with

those of its parent company (if any), are

less than $4 million, regardless of the

quantity of substances produced or

imported by that manufacturer or

importer. (3) Inflation index. EPA shall make

use of the Producer Price Index for

Chemicals and Allied Products, as

compiled by the U.S. Bureau of Labor

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Statistics, for purposes of determining

the need to adjust the total annual sales

values and for determining new sales

values when adjustments are made. EPA

may adjust the total annual sales values

whenever the Agency deems it

necessary to do so, provided that the

Producer Price Index for Chemicals and

Allied Products has changed more than

20 percent since either the most recent

previous change in sales values or the

date of promulgation of this rule,

whichever is later. EPA shall provide

Federal Register notification when

changing the total annual sales values.

"Small quantities solely for research

and development" (or "small quantities

solely for purposes of scientific

experimentation or analysis or chemical

research on, or analysis of, such

substance or another substance,

including such research or analysis for

the development of a product") means

quantities of a chemical substance

manufactured, imported, or processed or

proposed to be manufactured, imported,

or processed solely for research and

development that are not greater than

reasonably necessary for such purposes.

"Substance" means either a chemical

substance or mixture unless otherwise

indicated.

"Test marketing" means the

distribution in commerce of no more

than a predetermined amount of a

chemical substance, mixture, article

containing that chemical substance or

mixture, or a mixture containing that

substance, by a manufacturer or

processor, to no more than a defined

number of potential customers to

explore market capability in a

competitive situation during a

predetermined testing period prior to the

broader distribution of that chemical

substance, mixture, or article in

commerce.

"Total annual sales" means the total

annual revenue (in dollars) generated by

the sale of all products of a company.

Total annual sales must include the total

annual sales revenue of all sites owned

or controlled by that company and the

total annual sales revenue of that

company's subsidiaries and foreign or

domestic parent company, if any.

"TSCA" means the Toxic Substances

Control Act, 15 U.S.C. 2601 et seq.

§ 704.5 Exemptions.

A person who is subject to reporting

requirements for a substance identified

in this Part is exempt from those

requirements to the extent that the

person and that person's use of the

substance is described in this section.

This section is superseded by any TSCA

section 8(a) rule that adds to, removes,

or revises the exemptions described in

this section.

(a) Articles. A person who imports,

processes, or proposes to import or

process a substance identified in this

Part solely as part of an article is

exempt from the reporting requirements

of this Part with regard to that

substance.

(b) Byproducts. A person who

manufactures, imports, or proposes to

manufacture or import a substance

identified in this Part solely as a

byproduct is exempt from the reporting

requirements of this Part.

(c) Impurities. A person who

manufactures, imports, processes, or

proposes to manufacture, import, or

process a substance identified in this

Part solely as an impurity is exempt

from the reporting requirements of this

Part.

(d) Non-isolated intermediate. A

person who manufactures or proposes to

manufacture a substance identified in

this Part solely as a non-isolated

intermediate is exempt from the

reporting requirements of this Part.

(e) Research and development A

person who manufactures, imports,

processes, or proposes to manufacture,

import, or process a substance identified

in this Part only in small quantities

solely for research and development is

exempt from the reporting requirements

of this Part.

(f) Small manufacturers and

importers. Small manufacturers and

importers are exempt from the reporting

requirements of this Part.

5. By revising the section heading for

§ 704.7 to read as follows:

§ 704.7 Confidential business Information

claims.

6. By adding § § 704.9, 704.11, and

704.13 to read as follows:

§ 704.9 Where to send reports.

Reports must be submitted by

certified mail:to: TSCA Document

Processing Center (TS-790), Office of

Toxic Substances, U.S. Environmental

Protection Agency, Room L-100, 401 M

St., SW., Washington, DC 20460,

ATTENTION: 8(a) Reporting.

§ 704.11 Recordkeeplng.

Each person who is subject to the

reporting requirements of this Part must

retain the following records for 3 years

following the creation or compilation of

the record.

(a) A copy of each report submitted by

the person in response to the

requirements of this Part.

(b) Materials and documentation

sufficient to verify or reconstruct the

values submitted in the report.

(c) A copy of each notice sent by the

person, return receipt requested, to that

person's customers for the purpose of

notifying their customers of the

customer's reporting obligations under

this Part.

(d) All return receipts signed by the

person's customers who received the

notice described in paragraph (c) of this

section.

(Approved by the Office of Management and

Budget under OMB control number 2010-

0019)

§ 704.13 Compliance and enforcement.

Violators of the requirements of this

Part may be subject to civil

administrative penalties up to $25,000

per day of violation or criminal

prosecution, as provided in sections 15

and 16 of TSCA. In addition, under

section 17, EPA may seek judicial relief

to compel submission of required

information.

7. By amending Subpart B as follows:

Subpart B-Chemical-Specific

Reporting and Recordkeeping Rules

a. By revising the heading for Subpart

B to read as set forth above.

§§ 704.03,704.85, and 704.142

[Redesignated as §9 704.43, 704.45 and

704.102].

b. By redesignating existing § § 704.83,

704.85, and 704.142 under Subpart B as

§ § 704.43, 704.45, and 704.102

respectively.

§9 704.195 and 704.205 [Removed].

c. By removing § § 704.195 and 704.205.

8. By adding Subpart C to read as

follows:

Subpart C--CAIR: Comprehensive

Assessment Information RuleGeneral Reporting and Recordkeeping

Provisions

Sec.

704.200. Overview of CAIR provisionsSubparts C and D.

704.203 Definitions.

704.205 Limitations on reporting

requirements. 704.206 Persons who must report. 704.207 Information to be reported. 704.208 Distribution of substances under a

trade name.

704.210 Exemptions. 704.212 Questions selected.

704.214 Coverage period. 704.215 Reporting period. 704.216 How to obtain a CAIR reporting

form.

704.217 How to submit completed CAIR

reporting forms.,

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Sec.

704.219 Confidential business information

claims.

§ 704.200 Overview of CAIR provisionsSubparts C and D.

Although the provisions in Subpart A

of this Part apply to all of Part 704, EPA

may in Subpart C and D of this Part

modify the Subpart A provisions of this

Part for the purposes of requiring

reporting and recordkeeping provisions

on specified substances. In the event of

a conflict between the provisions of

Subparts A and C of this Part, the

provisions of Subpart C of this Part shall

govern. Subpart C of this Part explains

the reporting and recordkeeping

provisions for persons who

manufacture, import, or process the

substances identified in Subpart D of

this Part. Subpart D of this Part

identifies: the substances for which EPA

requires the reporting of information

under CAIR; the persons who are

required to submit the information; the

questions from the CAIR reporting form

that must be answered; the time period

on which to report; and the effective

date of the final rule. The text of Subpart

D of this Part is set out in a matrix

format and uses symbols to identify

some reporting requirements. These

symbols are explained in § 704.206. In

addition to the matrix, Subpart D also

identifies when all reporting forms must

be submitted.

§ 704.203 Definitions.

All definitions as set forth in section 3

of TSCA and § 704.3 apply in this

Subpart. In addition, the following

definitions are provided for the purposes

of this Subpart.

"Coverage period" means a time-span

which is I day less than 2 years, as

identified in Subpart D, and is the timespan which a person uses to determine

his/her reporting year. Subject

manufacturing or processing activities

may or may not have occurred during

the coverage period.

"Manufacturing activities" means all

those activities at one site which are

necessary to produce a substance

identified in Subpart D of this Part and

make it ready for sale or use as the

listed substance, including purifying or

importing the substance.

"Processing activities" means all

those activities which include (1)

preparation of a substance identified in

Subpart D of this Part after its

.manufacture to make another substance

for sale or use, (Z) repackaging of the

identified substance, or (3) purchasing

and preparing the identified substance

for use or distribution in commerce...

"Repackager" means a person who

buys a substance identified in Subpart D

of this Part or mixture, removes the

substance or mixture from the container

in which it was bought, and transfers

this substance, as is, to another

container for sale.

"Reporting Period" means the time

period during which CAIR reporting

forms are to be submitted to EPA.

"Reporting Year" means the most

recent complete corporate fiscal year

during which a person manufactures,

imports, or processes the listed

substance, and which falls within a

coverage period identified with a

substance in Subpart D of this Part.

"Small processor" means a processor

that meets either of the following

standards:

(1) First Standard. A processor of a

substance is small if its total annual

sales, when combined with those of its

parent company (if any), are less than

$40 million. However, if the annual

processing volume of a particular

substance at any individual site owned

or controlled by the processor is greater

than 45,400 kilograms (100,000 pounds),

the processor shall not qualify as small

for purposes of reporting on that

substance at that site, unless the

processor qualifies as small under

standard (2) of this definition.

(2) Second standard. A processor of a

substance is small if its total annual

sales, when combined with those of its

parent company (if any), are less than $4

million, regardless of the quantity of

substances processed by that processor.

(3) Inflation index. EPA shall make

use of the Producer Price Index for

Chemicals and Allied Products, as

compiled by the U.S. Bureau of Labor

Statistics, for purposes of determining

the need to adjust the total annual sales

values and for determining new sales

when adjustments are made. EPA may

adjust the total annual sales values

whenever the Agency deems it

necessary to do so, provided that the

Producer Price Index for Chemicals and

Allied Products has changed more than

20 percent since either the most recent

previous change in sales values or the

date of promulgation of this rule,

whichever is later. EPA shall provide

Federal Register notification when

changing the total annual sales values.

§ 704.205 umitatuons on reporting requirements.

The following limitations apply to the

reporting and recordkeeping

requirements of Subpart D of this Part.

(a) Report on TSCA-regulable

quantities. A person must report on only

thequantityof a substance that is

defined as a chemical substance under

TSCA section 3(2).

(b) Chemical substances from natural

sources. A manufacturer of a chemical

substance which is mined or extracted

from minerals, ores, petroleum, natural

gas, quarried nonmetallic minerals

(including extraction of salts from

seawateror brines), coal, or

atmospheric gases, or from any other

natural source, must report only about

the manufacturing steps taken, and the

uses of, that substance, and not about

production of the natural source

material or other crude precursors

derived from the natural source

material.

§ 704.206 Persons who must report.

(a) General requirements.

Manufacturers, importers, and

processors must report on each

substance identified in Subpart D of this

Part if: they are designated in Subpart D

as a person who must report on the

substance, they manufactured, imported,

or processed the substance during the

coverage period designated in Subpart D

for which reporting on that substance is

required, and they are not otherwise

exempt.

(b) Symbols for designating persons

who must report. EPA will designate

who must report on each substance

identified in Subpart D of this Part by

using the following symbols:

(1) "M" means each person who

manufactured the substance for

commercial purposes.

(2) "I" means each person who

imported the substance for commercial

purposes.

(3) '7" means each person who

processed the substance for commercial

purposes.

(4) "X/P" means each person who

manufactured, imported, or processed

the substance for commercial purposes

and distributed the substance under a

trade name.

(c) Special provision for importers.

When two or more persons are involved

in a particular Import transaction of a

substance identified in Subpart D of this

Part, and two or more of these persons

meet the definition of "importer" for this

transaction, they may determine among

themselves who should comply with the

CAIR reporting and recordkeeping

requirements for the substance and have

that person list the names of the other

importers who were involved in the

transaction. If none of the persons

involved comply with the CAIR

reporting and recordkeeping

-requirements for that substance, then

EPA will hold each of these persons

liable for their failure to comply.

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(d) Dual designations. If a person is

engaged in more than one activity (e.g., manufacturing and processing) at the

same site for a substance identified in

Subpart D of thisPart and both

activities are listed, then that person

must comply with the reporting

requirements for both activities.

§ 704.207 Information to be reported.

(a) The CAIR reporting form is

comprised of 10 sections. Each section

contains specific questions which

pertain to the subject matter found in

that particular section. There is a set of

instructions which accompanies the

CAIR reporting form. The instructions

consist of: specific directions and

sample answers relating to certain form

questions based on two reporting

scenarios, conversion tables, and a

glossary which defines key terms. The

following is a description of the

information contained in each section of

the CAIR reporting form.

(1) Section 1: General Manufacturer,

Importer, and Processor Information.

Respondent Identification

Reporting Status

Certification Statements

Corporate Data

Mixture Identification

(2) Section 2: Manufacturer, Importer,

and Processor Volume, and Use.

Respondent Activities

Quantity Manufactured, Imported, and

Processed

Quantity Exported Quantity Stored on-site

Product Types

Transportation off-site

Customer Use

(3) Section 3: Processor Raw Material

Identification.

Quantity Used and Price of Listed

Substance

Transportation to Site

Listed Substance in the Form of a

Mixture

(4) Section 4: Physical/Chemical

Properties.

Purity of Listed Substance

MSDS Exists/Submitted

Physical State of Listed Substance

Particle Size of Listed Substance

Fire, Explosion, and Other Hazard Data

Shipment Restrictions

(5) Section 5: EnvironmentalFate.

Rate Constants and Transformation

Products

Partition Coefficients

(6) Section 6: Economic and Financial

Information.

Company Type Product Types/Product Markets

Commercially Available Substitutes

Production Costs

Product Sales

(7) Section 7: Manufacture and

Process Information.

Process Block Flow Diagrams

Unit Operation Equipment Types

Process Stream Description and

Characterization

(8) Section 8: Residual Treatment,

Generation, Characterization,

Transportation, and Management.

Residual Treatment Block Flow

Diagrams

Unit Operation Equipment Types

Process Stream Description and

Characterization

Residual Management Methods

Residual Handling Instructions/

Restrictions

Storage or Treatment in Tanks and

Waste Piles

Storage, Treatment, or Disposal in

Containers

Residual Handling

Burning in Boilers and Incinerators

Storage, Treatment, or Disposal in Land

Treatment Sites and Surface

Impoundments

Disposal in Landfill Cells and Injection

Wells

(9) Section 9: Worker Exposure.

Employment and Potential Exposure

Profile

Records Maintained for Workers

Job Titles by Labor Category

Exposure Characterization -

Process Block Flow Diagram with

Associated Work Areas

Description of Work Areas and Worker

Activities

Work Place Monitoring Programs

Personal/Ambient Air Monitoring

Medical, Monitoring Tests

Engineering Controls

Equipment/Process Modifications

Personal Protective Clothing and Safety

Equipment

Respirator Maintenance Activity and

Training Programs

Work Practices

Housekeeping Tasks

Medical, Leak, Spill, Worker Safety, and

Health Plans

(10) Section 10: Environmental

Release.

Plant Location

Meteorological Conditions

Groundwater Below Plant Site

Routine Releases

Quantity of Listed Substance Released

Control Technologies

Point Source Emissions

Emission Characteristics

Equipment Leaks and Detection

Pressure Relief Devices with Controls

Raw Material, Intermediate, and Product

Storage Emissions

NPDES, POTW, and Non-point

Discharges

Releases to Soils, Groundwater, and

Drinking Water

Spills and Other Non-routine Releases

Weather Conditions, Date and Time of

Release

Method of Release and Quantity

Released

Cause and Result of Release

Authorities and Population Notified

Personal Injuries and Casualties

Release Prevention Practices

Repairs and/or Preventative Measures

(b) [Reserved]

§ 704.208 Distribution of substances

under a trade name.

(a) The X/P designation requires each

person who manufactured, imported, or

processed a substance identified in

Subpart D of this Part for conunercial

purposes and who distributed the

substance under a trade name to do one

of the following.

(1) Trade name list. Submit to EPA a

list of all trade names under which the

person distributes the substance.

Submissions must have a postmark date

no later than I day after the effective

date of the final rule listing the

substance in Subpart D of this Part.

Trade name lists must be submitted by

certified mail to: TSCA Document

Processing Center (TS-790), Office of

Toxic Substances, Environmental

Protection Agency, Room L-100, 401 M

St., SW., Washington, DC 20460,

ATTENTION: CAIR Trade Name List.

Include the date of the Federal Register

notice you are subject to, the substance

name, CAS number, trade name(s)

associated with that substance, the

company's name, address and telephone

number, and the address and telephone

number of a technical contact. EPA will

issue all submitted trade names in a

Federal Register notice in order to notify

all processors of these trade name

substances of their CAIR reporting and

recordkeeping obligations.

(2) Customer reporting. Submit to EPA

a CAIR reporting form that answers the

processor's reporting requirements for

each customer who would be required to

report if the customer knew it was

processing the listed substance. Persons

may only choose to report for their

customers if such persons can supply all

of the information requested. Persons

reporting on their customers' activities

are liable for information reported

incorrectly just as they are for reporting

incorrectly on their own activities.

Reporting is due no later than 90 days

after the effective date of the final rule

listing the substance in Subpart D of this

Part.

(3) Customer notification. Notify each

customer who would be required to

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report if the customer knew they were

processing the listed substance, of the

specific section in Subpart D of this Part

which identifies the substance and the

processor reporting requirements. The

customer notification must be sent by

certified mail, return receipt requested,

within 30 days of the effective date of

the final rule that added the substance

to Subpart D of this Part. The

notification must specify which

questions from the form must be

answered, on which trade name.

substances, when the reports are due,

the citation and date of the final rule

that added the substance to Subpart D,

and where to send the reports.

Customers must report within the time

period indicated in § 704.223(b).

(b) Notification extensions. Any

person who chooses to notify their

customers of their reporting obligations,

but cannot meet the notification

deadline, may apply for a reasonable

extension of time. Requests for

extensions must be made in writing,

contain a justification for such a request,

and be addressed to: TSCA Document

Processing Center (TS-790), Office of

Toxic Substances, U.S. Environmental

Protection Agency, Room L-100, 401 M

St., SW., Washington, DC 20460,

ATTENTION: CAIR customer

notification extension. Extension

requests must be postmarked no later

than 5 days before the notificationdeadline.

(c) [Reserved]

§ 704.210 Exemptions.

The reporting exemptions set out in

§ 704.5 apply to CAIR reporting

requirements. This section contains

additional exemptions from reporting

that also apply to CAIR reporting

requirements. EPA may modify

exemptions for CAIR reporting

requirements for specific substances by

specifying the modification in Subpart D

of this Part.

(a) Repackager. A person who is

solely a repackager as defined in

§ 704.203, and does not engage in any

other processing activities, is exempt

from the reporting and recordkeeping

requirements of this Subpart. (b) Smallprocessor. A person who

qualifies as a small processor as this

term is defined in J 704.203 is exempt

from the reporting and recordkeeping

requirements of this Subpart.

(c) Previous submission of data. (1) A

submitter who previously provided

information on a substance identified in

Subpart D of this Part to EPA or another

Federal agency on a CAIR reporting

form qualifies for a partial exemption

from current reporting requirements for

that substance and site if the person

previously reported voluntarily or

pursuant to previous reporting and

recordkeeping requirements of this

Subpart. The previously submitted

report must have covered a complete

corporate fiscal year that ended no more

than 3 years before the effective date of

the current reporting requirements for

the substance, and the data on the

previously submitted CAIR form must

be current, accurate, and complete for

the reporting year determined using the

coverage periods specified in Subpart D

of this Part.

(2) If the submitter qualifies for this

partial exemption because the submitter

previously submitted information

voluntarily to EPA or another agency,

then that person may, in response to a

specified reporting requirement on a

substance identified in Subpart D of this

Part, submit only a completed Section'l

of the CAIR reporting form and a copy

of the previous submission. To use this

partial exemption, the person must sign

the certification set out in Section 1 of

the CAIR reporting form that pertains to

the use of this exemption.

(3) If the submitter qualifies for this

partial exemption because the submitter

previously submitted information to

EPA pursuant to reporting requirements

of this Subpart, then that person may, in

response to a specified reporting

requirement on a substance identified in

Subpart D of this Part, submit only a

completed Section I of the CAIR

reporting form and indicate the date of

and the technical contact for the

previous submission. To use this partial

exemption, the person must sign the

certification set out in Section 1 of the

CAIR reporting form that pertains to the

use of this exemption.

§ 704.212 Questions selected.

(a) Designated questions. Each person

who is required to report on a substance

identified in Subpart D of this Part must

answer only the CAIR reporting form

questions designated in Subpart D. A

CAIR reporting form and instructions

can be obtained from the TSCA

Assistance Office as outlined in

§ 704.216.

(b) Specifying the questions. (1) The

questions selected will always include

Section 1 of the CAIR reporting form.

(2) Other questions selected will be

specified by section or question number

(e.g., 3 all or 3.01 and 3.02).

(i) Whenever the questions selected

specify a section of the CAIR reporting.

form followed by the word "all," each

person who is required to report on the

identified substance must answer all

parts of each question within the

section.

(ii) Whenever the questions selected

specify a question from the CAIR

reporting form, each person who is

required to report on the identified

substance must answer all parts of the

question.

(c) One report per site. Each person

who is required to report on a substance

identified in Subpart D of this Part must

report the required information

separately for each site at which that

person manufactured, imported, or

processed the substance.

(d) Activities on which to report Each

person who is required to report on a

substance identified in Subpart D of this

Part must report the required

information for each activity which

occurs at the site. If a person is engaged

in more than one activity (e.g.,

manufacturing and processing) at the

same site with respect to the substance,

such person is only required to report on

the activity or activities specified in

Subpart D. If a person is required to

report on more than one activity for the

same substance, such person must

report on all specified activities on the

same form.

§ 704.214 Coverage period.

(a) Each person who is required to

report on a substance identified in

Subpart D of this Part must comply with

the reporting requirement for the

coverage period designated in the

Subpart D matrix.

(b) EPA will specify for each reporting

requirement the coverage period on

which the information must be reported.

(c) Activities which occurred during a

coverage period are reportable if they

occurred during the reporting year.

(d) Persons who were engaged in

reportable activities in more than one

coverage period must report only on the

most recent coverage period in which

the activities occurred.

§ 704.215 Reporting perod.

(a) When reports are due. (1 Persons

who are required to report on a

substance identified in Subpart D of this

Part, including those who choose to

report for their customers who process

the identified substance, must submit

their completed CAIR forms during the

reporting period identified in

§ 704.223(a).

(2) Persons who were notified by a

supplier that reporting is required on a

trade name substance, must submit their

completed CAIR forms during the

reporting period identified in

§ 704.223(b).

(b) Reporting extensions. Persons who

cannot submit their reports by the

deadline as specified in § 704.223 may

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apply for a reasonable extension of

time. Requests for extensions must be

made in writing, contain a justification

for such requests, and be addressed to:

TSCA Document Processing Center {TS790), Office of Toxic Substances, U.S.

Environmental Protection Agency, Room

L--100, 401 M St., SW., Washington, DC

20460, ATrENTION: CAIR reporting

extension. Extension requests must be

postmarked no later than 30 days after

the effective date of the addition of a

substance or mixture to Subpart D of

this Part or 30 days after notificationby

a supplier as described in J 704.208.

§ 704.216 How to obtain a CAIR reporting

form.

CAIR forms and instructions may be

obtained by telephoning or writing the

TSCA Assistance Office. Phone

Number (202) 554-1404, TDD (202) 554-

0551. Address: TSCA Assistance Office

(TS-799), Office of Toxic Substances,

Environmental Protection Agency. 401 M

St., SW., Washington, DC 20460.

§ 704.217 How to submit completed CAIR

reporting forms.

(a) Each person who is required to

report on a substance identified in

Subpart D of this Part may submit their

reports from the individual sites or

through the company headquarters.

However, a separate report must be

submitted for each substance at each

site at which the person engages in one

or more of the activities for which EPA

is requesting information.

(b) Submitters must send their

completed forms to: TSCA Document

Processing Center (TS-790), Office of

Toxic Substances, U.S. Environmental

Protection Agency, Rm. ,-100, 401 M St.,

SW., Washington, DC 20460.

ATTENTION: CAIR Reporting.

§ 704.219 Confidential business

information claims.

(a) Submitters may assert a

Confidential Business Information (CBI)

claim for information submitted In EPA

only if: the claim is asserted in

accordance with this section; and

release of the information would reveal

trade secrets or confidential commercial

or financial information, as provided in

section 14(a) of TSCA. EPA will place

all information not clained as

confidential in the manner described in

this section in the public file without

further notice to the respondent

(b) Submitters who assert a CBI claim

for submitted information must provide

EPA with two copies of their

submission. The first copy must be

complete and contain all information

being claimed as confidential. The

second copy must contain only

information not claimed as confidential.

EPA will place the second copy of the

submission in the public file. Failure to

furnish a second copy of the submission

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 submitter by certified mail that a

finding of a presumptive wavier of the

claim of confidentiality has been made.

The submitter has 30 days from the date

of receipt of notification to submit the.

required second copy. Failure to submit

the second copy will cause EPA to place

the first copy in the public file.

(c) Submitters may assert CBI claims

only at the time a completed CAIR form

is submitted and only in the specified

manner.

(1) Submitters must clearly mark all

information claimed as confidential.

Submitters can claim information

submitted on a reporting form as

confidential by placing in the CBI box.

which is adjacent to the question, the

letter or letters that indicate the

category of the information, as enumerated in paragraph (e) of this

section, which is being claimed

confidential. Respondents who claim

information submitted on continuation

sheets to the form as confidential must

do so by writing the word

"Confidential" at the top of the page on

which the information appears and by

placing brackets ([ ]) around the

information claimed confidential.

12) [Reserved]

(d) Submitters must substantiate all

claims of confidentiality at the time the

submitter asserts the claim (i.e., when

the reporting form is submitted). Failure

to provide substantiation of a claim at

the time the submitter submits the

reporting form will result in a waiver of

the confidentiality claim, and the

information may be disclosed to the

public without further notice to the

submitter.

(e) EPA has identified six information

categories as those which will

encompass all claims of confidentiality:

Submitter identity=h.

Substance identity=i,

Volume manufactured, imported, or

processed=j,

Use information=k,

Process information=l, and

Other information=m.

Submitters who assert a CBlI claim on

the reporting form must mark the letter

or letters (h through m) that represent

the appropriate category(ies) of

confidentiality for the information in the

box adjacent to the question.

Confidentiality claims for information

on continuation sheets are asserted by

placing the appropriate letter(s) in the

margin by the information claimed

confidential.

(f) Submitters who assert any CBI

claims must substantiate all claims by

completing all applicable portions of the

CBI substantiation form found in

Appendix II of the CAIR reporting form.

9. Subpart D is added to read as

follows:

Subpart D-CAIR Specific Reporting

and Recordkeeping Requirements

Sec.

704.220 Chemical substance matrix

requirements.

704.223 Reporting period.

704.225 Chemical substance matrix by CAS .registry number.

§ 704.220 Chemical substance matrix

requirements.

For each substance listed in the

matrix in § 704.225, EPA has identified

the persons who must report on that

substance by means of the symbols M, I.

P, and X/P. An -explanation of these

symbols is given in § 704.206 of Subpart

C of this Part. These designated persons

must respond to all of the matrix's

reportingrequirements. All of the CAIR

reporting and recordkeeping

requirements are explained in Subpart C

of this Part. Persons who are required to

report must comply with Subpart C of

this Part.

§ 704.223 Reporting period.

(a) Reports must be submitted to the

Agency no latter than 90 days after the

effective date of the final rule listing the

substance in § 704,225, except as

described in § 704.223(b).

(b) Persons subject to X/P

designations and who chose to notify

their customers, must inform their

customers that reports are due within 90

days of receipt of notification.

§ 704.225 Chemical substance matrix by CAS registry number.

The following codes are used in this section.

M =Each Person who Manufactured the Substance for Commercial Purposes

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1= Each Person who imported the Substance for Commercial Purposes P=Each Person who Processed the Substance for Commercial Purposes X/P=Each Person who Manufactured, Imported, or Processed the Substance for Commercial Purposes and Distributed the Substance under a

Trade Name

(a) List of Chemicals.

ExempWho lions CAS No. chemical name must added Coverage period Questions selected Effective date

removed _____________ _________________________________ -) ______________________ ______________________ _____(-)_____

Hydrazinecarboxamide ..........................

Acetamide (Ethanamide).......................

79-27-6 .......... Ethane, 1,1,2,2-tetrabromo- .............

85-01-8 .... Phenanthrene ..................

Benzene, 1,3-diisocyanato-2-methyl-

(2,6-Toluene dilsocyanate).

2-Naphthalenesulfonic acid, 6-amino.

(Broenner's acid).

Benzenamine, 4,4'-methylenebis[2-

chloro- (MBOCA).

Ethanol, 2-chloro-, phosphate (3:1) (Tds(2-chloroethyl) phosphate).

X/P, P.I......

M, I...........

M, I...........I

X/P, P .........

Pyrene (Benzo~def]phenanthrene) ...... M. I . .....

91-08-7 .........

93-00-5 ........

101-14-4 ......

115-98 ........

129-00-0 ........

563-41-7 ........

584-84-9 ...... X/P, P .........

57-56-7 .........

60-35-5 .........

M, X/P,

I, P.

M, I .........

M, X/P,

I, P.

M, X/P,

I, P.

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1, 2.08, 2.12, 2.13, 9.02,

9.03, 9.06

1, 2.01, 2.04 thru 2.06,

2.08, 2.12 thru 2.14,

2.17, 3.04, 9.04 thru

9.07

1,2.08.2.12, 2.13

1, 2.01, 2.03, 2.05 thru

2.08, 2.11 thru 2.14,

2.16, 2.17, 9.02, 10.05,

10.08

1, 2.04 thru 2.09, 2.11

thru 2.16, 3 all, 4.01

thru 4.05, 5 all, 6.05,

7.01, 7.03 thru 7.06,

8.01, 8.05, 8.06, 8.23,

9.01 thru 9.15, 9.19,

9.20, 9.22, 10.01,

10.02, 10.05, 10.08 thru

10.16, 10.23

1, 2.04 thru 2.09, 2.11

thru 2.16, 3 all, 4.01

thru 4.05, 5 all, 6.05,

7.01, 7.05, 7.08, 8.01,

8.05, 8.06, 8.23, 9.01

thru 9.15, 9.19, 9.20,

9.22, 10.01, 10.02,

10.05, 10.09 thru 10.16,

10.23

1, 2.01, 2.04 thru 2.06,

2.08, 2.11, 2.12, 2.17,

3.04, 4.01, 9.07, 10.05,

10.08

1, 9.01, 9.03, 9.06, 9.08,

9.12, 9.15

1, 2.01, 2.03, 2.05 thru

2.08,2.11 thru 2.14,

2.16, 2.17, 9.02, 10.05,

10.06

1, 2.01, 2.03, 2.05 thru

2.08, 2.11 thru 2.14,

2.16, 2.17, 9.02, 10.05,

10.06

1, 2.08, 2.12, 2.13, 9.02,

9.03, 9.06

1, 2.04 thru 2.09, 2.11

thru 2.16, 3 all, 4.01

thru 4.05, 5 all, 6.05,

7.01, 7.03 thru 7.06,

8.01, 8.05, 8.06, 8.23,

9.01 thru 9.15, 9.19,

9.20, 9.22, 10.01,

10.02, 10.05, 10.08 thru

10.16, 10.23

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Hydrazinecarboxamide, monohydrochloride (Semicarbazide hydro- chloride).

Benzene, 2,4-dlisocyanato- 1-methyl..

(2,4-Toluene diisocyanate).

M, X/P,

!, P.

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Who EnP

CAS No. Chemical name m dded Coverage period Questions selected Effective date

report removed

Disuffide, dimethyl (Dimethyl disulfide).

Benzene, diisocyanatomethyl- (Un- specific toluene dilsocyanate).

Hydroxylamine, hydrochloride (Hydroxylammonium chloride).

C hlorine ....................................................

Hydroxylamine (Oxammonium) .............

Hydroxylamine, sulfate (2:1) (Hydroxylammonium).

Hydroxylamine, sulfate (1:1) (Hydroxylamine acid sulfate).

Benzene, 1,3-diisocyanatomethyl

(Toluene disocyanate).

M ., . ..... .................

X/P, P ..............

624-92-0 ........

1321-38-6 ......

5470-11-1 ......

7782-50-5 .....

7803-49-8 ......

10039-54-0 ..

10046-00-1...

26471-62-5...

M.I........................

M, I .......... 2/8/87-215/89

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1, 2.04 thru 2.09, 2.1i

thru 2.16,,3 all, 4.01

thru 4.05, 5 all, 6.05,

7.01, 7.05, 7.06, 8.01,

8.05, 8.06, 8.23, 9.01

thru 9.15, 9.19, 9.20,

9.22, 10.01, 10.02,

10.05, 10.09 thru 10.16,

10.23

1, 2.01, 2.03, 2.05 thru

2.08, 2.11 thru 2.14,

2.16, 2.17, 9.02, 10.05.

10.06

1, 2.04 thru 2.09, 2.11

thru 2.16, 3 all, 4.01

thru 4.05, 5 all, 6.05,

7.01, 7.03 thru 7.06,

8.01, 8.05, 8.06, 8.23,

9.01 thru 9.15, 9.19,

9.20, 9.22, 10.01,

10.02, 10.05, 10.06,

10.08 thru 10.16, 10.23

1, 2.04 thru 2.09, 2.11

thru 2.16, 3 all, 4.01

thru 4.05, 5 all, 6.05,

7.01, 7.05, 7.06, 8.01,

8.05, 8.06, 8.23, 901

thru 9.15, 9.19, 9.20,

9.22, 10.01, 10.02,

10.05, 10.06, 10.09 thru

10.16, 10.23

1, 2.07, 2.12 thru 2.14,

3.04, 6.03 thru 6.05,

9.01

1, 2.05 thru 2.07, 2.11,

4.01, 7.03 thru 7.06,

10.02, 10.08

1, 2.07, 2.12 thru 2.14,

3.04, 6.03 thru 6.05,

9.01

1, 2.07, 2.12 thru 2.14,

3.04, 6.03 thru 6.05,

9.01

1, 2.07, 2.12 thru 2.14,

3.04, 6.03 thru 6.05,

9.01

1, 2.04 thru 2.09, 2.11

thru 2.16, 3 all, 4.01

thru 4.05, 5 all, 6.05,

7.01, 7.03 thru 7.06,

8.01, 8.05, 8.06, 8.23,

9.01 thru 9.15, 9.19,

9.20, 9.22, 10.01,

10.02, 10.05, 10.06,

10.08 thru 10.16, 10.23

1, 2.04 thru 2.09, 2.11

thru 2.16, 3 all, 4.01

thru 4.05, 5 all, 6.05,

7.01, 7.05, 7.06, 8.01,

8.05, 8.06, 8.23, 9.01

thru 9.15, 9.19, 9.20,

9.22, 10.01, 10.02,

10.05, 10.06, 10.09 thru

10.16, 10.23

(b) lReserved]

FR Doc. 88-26445 Filed 12-21,-88; 8:45 am]

BILLING CODE 6560-50-M

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M, ........

M, X/P,

I, P.

M .............

M, X/P,

1, P.

M, X/P,

I, P.

M, X/P,

t, P.

X/P, P .....

...........

..........

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