Federal Register / Vol. 53, No. 221 / Wednesday, November 16, 1988 /' Rules and Regulations 46279

ENVIONMETAL ROTETIO

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 712 and 716

[OPTS44029; FRL-3476-3]

Preliminary Assessment Information

and Health and Safety Data Reporting;

Addition of Chemicals

AGENCY. Environmental Protection

Agency (EPA)

ACTION: Final rule.

SUMMARY: The Interagency Testing

Committee fITC) in its Twenty-third

Report to EPA recommended that EPA

give priority consideration to six

chemical substances in proposing

chemical test rules. To assist EPA in its

determination of which, if any, tests are

needed for these substances, EPA is

adding the six substances to two model

information-gathering rules: The Toxic

Substances Control Act (TSCA) section

8(a) Preliminary Assessment

Information Rule (PAIR), and the TSCA

section 8(d) Health and Safety Data

Reporting Rule.

EFFECTIVE DATE: This rule shall become

effective on December 16,1988.

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), TDD: (202-554-0551).

SUPPLEMENTARY INFORMATION: This rule

adds six chemical substances to the

PAIR and the section 8(d) Health and

Safety Data Reporting Rule.

Manufacturers, processors, 'and

importers of these chemicals will be

required to report end use, exposure,

volume, and unpublished health and

safety data to the Agency.

Public reporting burden for this

collection of information is estimated to

average 32.7 hours per response,

including time for reviewing

instructions, searching existing data

sources, gathering and maintaining the

data needed, and completing and

reviewing the collection of information.

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, PM223, U.S. Environmental.Protection

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

20460; and to the Office of Information

and Regulatory Affairs, Office of

Management and Budget, Washington,

DC 20503.

I. Background

Section 4(e) of TSCA established the

ITC and authorized it to recommend to

EPA chemical substances and mixtures

(chemicals) to be given priority

consideration in proposing chemical test

rules. For some of these chemicals theITC may designate that EPA must

respond to its recommendations within

12 months. In this time, EPA must either

initiate a rulemaking to test the chemical

or publish in the Federal Register its

reasons for not doing so. For the

remainder of the recommended

substances, no time limit for Agency

response is imposed.

Elsewhere in today's issue of the

Federal Register, EPA is announcing the

receipt of the Twenty-third Report of the

ITC, which was transmitted to EPA on

November 1198& The Twenty-third

Report revises and updates the

Committee's priority list of chemicals

and adds six substances to the section

4(e) priority list. This rule adds these six

substances to the PAIR and the section

8(d) Health and Safety Data Reporting

Rule which wil require manufacturers,

importers, and processors to report

volume, end use, exposure, and

unpublished health and safety data to

EPA. In addition, one chemical

substance which 1iad been

recommended with intent-to-designate

by the ITC in its Twenty-second Report,

2-Butenal, CAS No. .4170-30-3. is now

designated for response within 12

months. This revision does not'trigger

any new reporting requirements because

following the recommendation with

intent-to-designate, 2-Butenal (also

known as Crotonaldehyde), was added

to the PAIR (53 FR 18211, May 20,1988)

and the section aid) Health and Safety

Data Reporting Rule 151 FR 2890,

January 22,1986), as published in the

Federal Register of May 20, 1988 (53 R

18190).

To assist EPA in responding to the

ITC recommendations, EPA has

developed two model informationgathering rules (PAIR and the section

8(d) Health and Safety Data Reporting

Rule) which provide for the automatic

addition of ITC priority list substances.

Whenever EPA announces the receipt of

an ITC report, EPA may, at the same

time without notice and comment,

amend the two model informationgathering rules by adding the

recommended substances. The

amendment adding these substances to

the PAIR and the Health and Safety

Data Reporting Rule becomes effective

30 days after publication.

EPA issued PAIR under section 6(s) of

TSCA (15 U.S.C. 2007(a)), and it is

codified at 40 CFR Part 712. This model

section 8[a) rule established standard

reporting requirements for

manufacturers and importers of the

chemicals listed in the rule. These

manufacturers and importers are

required to submit a one-time report on

general volume, end use, and exposure

information using the Preliminary

Assessment Information Manufacturer's

Report (EPA Form No. 7710-35). EPA

uses this model section 8(a) rule to

gather current information on

substances of concern quickly.

EPA issued the model Health and

Safety Data Reporting Rule under

section 8(d) of TSCA (15 U.S.C. 2807(d)),

and it is codified at 40 CFR Part 716.

EPA revised the section 8(d) model rule

on September 15,1986851 FR 32720). The

section 8Jd) nmdel rule requires past,

current. and prospective manufacturers,

importers, and processors of listed

chemical substances and mixtures to

submit to EPA copies 'and lists of

unpublished health and safety studies

on the listed chemicals that they

manufacture, import, or process. These

studies provide EPA with useful

information and have provided

significant support for EPA's

decisionmaking under TSCA sections 4,

5, 6, 8, and 9,

IL Chemicals to be Added

The following ITC priority list

substances for which reporting i's

required under 40 CFR Parts 712 and 716

are listed by ITC designation in

ascending Chemical Abstracts Service

Registry Number (CAS No.) order:

A. Designated for response within 12

months:

CAS No. andVame

4170-30-3 2-Butenal (also known as

Crotonaldehydej

B. Recommended with Intent-toDesignate:

CAS No. and Name

115-96-8 Ethanol,'2-chloro-, phosphate

(3,1) (alsoknown as Tris(2-

chloroethyl)-phosphate)

6145-73-9 1-PropanoL 2-chloro-,

phosphate [3:1) (also known as Tris[2-

chloro-1-propyl)phosphate)

13674-84-5 2-Propanol, 1-chloro-,

phosphate 13:1) (also known as Tris(1-

chloro-2-propyl)phosphate)

13674-87-8 2-Propanol, 1,3.dichloro-,

phosphate (3a1) (also known as

Tris(1,3-diclloro-2-propyl}phosphate)

33125-80-9 Phosphoric acid, 1,2-

ethanediyl tetrakis(Z-chloroethyl)

ester (also known as Tetrakis(2-

chloroethyl)ethylene disphosphate).
468 eea eitrIVl.5,N.21I dedy Novembe 16 98/Rlswn euain

C. Recommended without being

designated for response within 12

months:

CAS No. and name

123-72-8 Butanal (also known as

Butyraldehyde).

III. Reporting Requirements

A. Preliminary Assessment Information

Rule

All persons who manufactured or

imported the substances named in this

rule during their latest complete

corporate fiscal year must submit a

Preliminary Assessment Information

Manufacturer's Report (EPA Form No.

7710-35) for each manufacturing or

importing site at which they

manufactured or imported a named

substance. A separate form must be

completed for each substance and

submitted to the Agency no later than

February 14, 1989. Persons who have

previously and voluntarily submitted a

Manufacturer's Report to the ITC or EPA

should read § 712.30(a)(3). This section

allows these persons to submit a copy of

the original Report to EPA or to notify

EPA by letter of their desire to have this

submission accepted in lieu of a current

data submission.

Complete details of the reporting

requirements, including exemptions and

a facsimile of the reporting form, are

fully described in 40 CFR Part 712.

Copies of the form are available from

the TSCA Assistance Office at the

address which procedes Unit I.

B. Health and Safety Data Reporting

Rule

Listed below are the general reporting

requirements of the section 8(d) model

rule.

1. Persons who, in the 10 years

proceding the date a substance is listed,

either have proposed to manufacture,

import, or process, or have

manufactured, imported, or processed,

the listed substance must submit to EPA:

A copy of each health and safety

study which is in their possession at the

time the substance is listed.

2. Persons who, at the time the

substance is listed, proposed to

manufacture, import, or process; or are

manufacturing, importing, or processing

the listed substance must submit to EPA:

a. A copy of each health and safety

study which is in their possession at the

time the substance is listed.

b. A list of health and safety studies

known to them but not in their

possession at the time the substance is

listed.

c. A list of health and safety studies

that are ongoing at the time the

substance is listed and are being

conducted by or for them.

d. A list of each health and safety

study that is initiated after the date the

substance is listed and is conducted by

or for them.

e. A copy of each health and safety

study that was previously listed as

ongoing or subsequently initiated and is

now complete-regardless of completion

date.

3. Persons who, after the time the

substance is listed, propose to

manufacture, import, or process the

listed substance must submit to EPA:

a. A copy of each health and safety

study which is in their possession at the

time they propose to manufacture,

import, or process the listed substance.

b. A list of health and safety studies

known to them but not in their

possession at the time they propose to

manufacture, import, or process the

listed substance.

c. A list of health and safety studies

that are ongoing at the time they

propose to manufacture, import, or

process the listed substance, and are

being conducted by or for them.

d. A list of each health and safety

study that is initiated after the time they

propose to manufacture, import, or

process the listed substance, and is

conducted by or for them.

e. A copy of each health and safety

study that was previously listed as

ongoing or subsequently initiated and is

now complete-regardless of the

completion date.

Detailed guidance for reporting

unpublished health and safety data is

provided in the section 8(d) Health and

Safety Data Reporting Rule published in

the Federal Register of September 15,

1986 (51 FR 32720) (40 CFR 716.60). Also

found there are the reporting

exemptions.

C. Submission of PAIR Reports and

Section 8(d) Studies

PAIR reports and section 8(d) health

and safety studies must be sent to:

TSCA Document Processing Center (TS--

790), Office of Toxic Substances,

Environmental Protection Agency, 401 M

St., SW., Washington, DC 20460. ATTN:

(insert either PAIR or 8 (d) Reporting).

D. Removal of Chemicals From the

Rules

Any person who believes that section

8(a) or (d) reporting required by this rule

is unwarranted, should promptly submit

to the Agency in detail the reasons for

that belief. EPA may then remove the

substance from the rule, EPA will issue

a rule amendment for publication in the

Federal Register.

IV. Release of Aggregate Data

The Agency will follow procedures for

the release of aggregate statistics as

prescribed in a rule related notice

published in the Federal Register of June

13,1983 (48 FR 27041). Included in the

notice are procedures for requesting

exemptions from the release of

aggregate data. Exemption requests

concerning the release of aggregate data

on any chemical substance must be

received by EPA no later than February

14, 1989.

V. Economic Analysis

A. Preliminary Assessment Information

Rule

EPA estimates the PAIR reporting cost

of this rule is $33,635. To calculate this

figure EPA used the TSCA Inventory to

generate a list of manufacturers and

importers of these substances. Since no

companies qualify as small businesses

as defined in 40 CFR 712.25(c), EPA

expects thirteen firms to report a total of

twenty-five reports.

Reporting cost (dollars:

(a) 25 reports expected at $8071

report .......... .......................... (b) 20 familiarization cases at

$673/case .........................................

Total ................. ..................

Average cost per site ...............................

Average cost per firm .............................. Reporting burden (hours):

(a) familiarization: 18 hours pet site

x 20 sites ......................................... (b) reporting: 16 hours per report X

25 reports ..........................................

Total (hours) . ... . .............

EPA cost:

Processing Cost = 25 reports x $91/report.......................

$20,175

13,460

33,635

$1,681

2,587

360

400

760

$2,275

B. Health and Safety Data Reporting

Rule

EPA estimates the total reporting

costs for establishing section 8(d)

reporting requirements for these

substances is $19,680. This cost estimate

is relatively high, because the Agency is

uncertain about the likely number of

respondents to the rule. Although EPA

has used the best available data to

make its economic projections, much of

the data is not current. Therefore, EPA

intends to overestimate rather than

underestimate the reporting burden.

Nevertheless, the cost of this rule is

low in comparison with its potential

benefits. Health and safety studies

concerning these substances would

improve EPA's ability to identify

potential public health and

environmental problems with regard to

these chemicals. The Agency therefore

46280 Federal Registar / Vol, 53, No. 221 / Wednesday, November 16, 1988 / Rules and Regulations
Federal Register / Vol. 53, No. 221 / Wednesday, November 16, 1988 / Rules and Regulations 46281

would be better able to determine

whether further regulatory action would

be necessary.

The estimated reporting costs are

broken down as fullows:

Initial corporate revlew .............. $3,510

Site identification ...................................... 2,430

Fife searches at affected sites ............... 5,022

Title listing _. ............................ 252

Photocopying ......................................... . 842

Managerial review ......... .. 48860

Reporting on newly-initiated studies 120

Submissions after initial reporting

period ............................................... 2,060

Total ................................................ 19,680

VI. Rulemaking Record

The following documents constitute

the record for this rule (docket control

number OPTS-84029). All of these

documents 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-G04, 401 M St.,

SW., Washington, DC.

1. This final rule.

2. The economic analyses for this rule.

3. The Twenty-third Report of the ITC.

VII. Regulatory Assessment

Requirements

A. Executive Order 12291

Under Executive Order 12291, EPA

must judge whether a rule is "major"

and, therefore, subject to the

requirement of a Regulatory Impact

Analysis. This rule is not major because

it will not result in an effect on the

economy of $100 million or more, an

increase in costs or prices, or any of the

adverse effects described in the

Executive Order.

This amendment was not submitted to

the Office of Management and Budget

(OMB) for review, because the

automatic listing of designated

substances is provided for in 40 CFR

712.30(c) and 716.18(b)-final rules

which have been previously reviewed

by OMB under the terms of the

Executive Order.

B. Paperwork Reduction Act

The information collection

requirements contained in this rule have

been approved by OMB under the

provisions of the Paperwork Reduction

Act, 44 U.S.C. 3501 et seq. and have

been assigned OMB control numbers

2070-0054 and 2070-0004.

Public reporting burden for this

collection of information is estimated to

average 32.7 hours per response,

including time for reviewing

instructions, searching existing data

sources, gathering and maintaining'the

data needed, and completing and

reviewing the collection of information.

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, PM223, U.S. Environmental Protection

Agency, 401 M St., 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."

List of Subjects in 40 CFR Parts 712 and

716

Chemicals, Environmental protection.

Hazardous substance, Health and safety

data, Recordkeeping and reporting

requirements.

Dated: November 4,1988.

Joseph J. Merenda,

Director, Existing ChemicalAssessment

Division, Office of Toxic Substances.

Therefore, 40 CFR Chapter I is

amended as follows:

PART 712--AMENDED]

1. The authority citation for Part 712

continues to read as follows:

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

2. Section 712.30 is amended by

adding the following substances to

paragraph (w) in CAS Number order as

follows:

§ 712.30 Chemical lists and reporting periods. w* * *

(w) * * *

Effective Reporting CAS No. Substance date date

115-96-8 Ethanol, 2-chioro-, phosphate (3:1)........................................................................................................................................... ... 12/16188 2/14/89

123-72-8 Butanal ................ ............................... . ................................................................................ ........................................................... 12/16/88 2/14/89

6145-73-9 1-Propanol, 2-chloro-, phosphate (3:1) .............................................................................................................................................. 12/16/88 2/14/89

13674-84-5 2-Propanol, 1-chloro-, phosphate (3:1) .............. ........................................................... 12/16/88 2/14/89

13674-87-8 2-Propanol, rh 1,3-dichloro, phosphate (3:1) ............................................. .................................................................................. 12/188 2/14/89

33125-86-9 Phosphoric acid, 1,2-ethanediy tetrakis(2-chloroethyl) ester ........................................................................................................... 12/16188 2/14/89

(Approved by the Office of Authority: 15 U.S.C. 2607(d). §716.120 Substances and listed mixtures

Management and Budget under control 2. By adding substances to § 716.120(a) to which this subpart applies.

number 2070--0054.) numerically by CAS Number to read as

PART 716--AMENDED] follows: (a) * * *

1. The authority citation for Part 716

continues to read as follows:

CAS No. Substance Special Effective Sunset date exemptions date

115-96-8 Ethanol, 2-chloro-, phosphate (3:1) .................................................................................................................................................. 112116/88 12/16/98
46282 Federal Register / Vol. 53, No. 221 / Wednesday, November 16, 1988 / Rules and Regulations

CAS No. Substane Special Effective Sunset date exemptions date

* e a * a a a

123-72-4 Butansl .................................................. ....... .......................... ........................ 12/6188 12/16/98

6145-73-9 1-Propanol, 2-chloro-, phosphate (3:1) ........................................................................................................................................... 12/16/88 12/16/98

13674-84-5 2-Propanol, 1-chloro-, phosphate (3:1) .............................................................................................................................................. 12/16/88 12/16/98

13674-87-8 2-ProPao, 1,3-dichloro-, phosphate (3:1) ....................................................................................................... ......................... 12/16/88 12/16/98

33125-86-9 Phosphoric acid, 1,2-ethanediyl tetralks (2-chioroethyl) ester .................................................................. ......................... 12/16/88 12/16/98 • a • a * a a

(Approved by the Office of

Management and Budget under control

number 2070-0004.)

[FR Doc. 88-26305 Filed 11-15-68; 8:45 am)

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