Significant New Uses of Certain Chemical Substances

Federal RegisterJan 5, 2000

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[OPPTS-50635; FRL-6055-2]

RIN 2070-AB27

Significant New Uses of Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is promulgating significant new use rules (SNURs) under

section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 40

chemical substances which were the subject of premanufacture notices

(PMNs) and subject to TSCA section 5(e) consent orders issued by EPA.

Today's action requires persons who intend to manufacture, import, or

process these substances for a significant new use to notify EPA at

least 90 days before commencing the manufacturing or processing of the

substance for a use designated by this SNUR as a significant new use.

The required notice will provide EPA with the opportunity to evaluate

the intended use, and if necessary, to prohibit or limit that activity

before it occurs to prevent any unreasonable risk of injury to human

health or the environment. EPA is promulgating this SNUR using direct

final procedures.

DATES: The effective date of this rule is March 6, 2000 without further

notice, unless EPA receives adverse comment or notice of intent to

submit adverse comment before February 4, 2000. This rule shall be

promulgated for purposes of judicial review at 1 p.m. (e.s.t.) on

January 19, 2000.

If EPA receives adverse comment or notice before February 4, 2000

that someone wishes to submit adverse or critical comments on EPA's

action in establishing a SNUR for one or more of the chemical

substances subject to this rule, EPA will withdraw the SNUR before the

effective date for the substance for which the comment or notice of

intent to comment is received and will issue a proposed SNUR providing

a 30-day period for public comment.

ADDRESSES: Comments or notice of intent to submit adverse or critical

comments may be submitted by mail, electronically, or in person. Please

follow the detailed instructions for each method as provided in Unit

I.C. of the ``SUPPLEMENTARY INFORMATION'' section. To ensure proper

receipt by EPA, it is imperative that you identify docket control

number OPPTS-50635 in the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: For general information contact: Joe

Carra, Deputy Director, Office of Pollution Prevention and Toxics

(7401), Environmental Protection Agency, 401 M St., SW., Washington, DC

20460, telephone numbers: (202) 554-1404 and TDD: (202) 554-0551; e-

mail address: TSCA-H[email protected].

For technical information contact: James Alwood, Chemical Control

Division (7405), Office of Pollution Prevention and Toxics,

Environmental Protection Agency, Rm. E-435, 401 M St., SW., Washington,

DC 20460, telephone number: (202) 260-1857; e-mail address:

[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you manufacture,

import, process, or use the chemical substances contained in this rule.

Potentially affected categories and entities may include, but are not

limited to:

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Examples of

Categories NAICS Potentially

Affected Entities

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Chemical manufacturers 325 Manufacturers,

importers,

processors, and

users of

chemicals

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Petroleum and coal product 324 Manufacturers,

industries importers,

processors, and

users of

chemicals

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This listing is not intended to be exhaustive, but rather provides

a guide for readers regarding entities likely to be affected by this

action. Other types of entities not listed in the table in this unit

could also be affected. The North American Industrial Classification

System (NAICS) codes have been provided to assist you and others in

determining whether or not this action applies to certain entities. To

determine whether you or your business is affected by this action, you

should carefully examine the applicability provisions in 40 CFR 721.5.

If you have any questions regarding the applicability of this action to

a particular entity, consult the technical person listed in the ``FOR

FURTHER INFORMATION CONTACT.''

B. How Can I Get Additional Information, Including Copies of this

Document and Other Related Documents?

1. Electronically. You may obtain copies of this document, and

certain other related documents that might be available electronically,

from the EPA Internet Home Page at http://www.epa.gov/. You may also

obtain copies of the notice of availability documents for the 835 (63

FR 4259, January 28, l998) (FRL-5761-7), 850 (62 FR 16486, April 15,

l996) (FRL-5363-1), and 870 (63 FR 41845, August 5, l998) (FRL-5740-1)

series OPPTS harmonized test guidelines at this same site. To access

these documents, on the Home Page select ``Laws and Regulations'' and

then look up the entry for this document under the ``Federal Register

Environmental Documents.'' You can also go directly to the Federal

test guidelines referenced in this document are available on EPA's

Internet Home Page at http://www.epa.gov/OPPTS-Harmonized/.

2. In person. The Agency has established an official record for

this action under docket control number OPPTS-50635. The official

record consists of the documents specifically referenced in this

action, any public comments received during an applicable comment

period, and other information related to this action, including any

information claimed as Confidential Business Information (CBI). This

official record includes the documents that are physically located in

the docket, as well as the documents that are referenced in those

documents. The public version of the official record does not include

any information claimed as CBI. The public version of the official

record, which includes printed, paper versions of any electronic

comments submitted during an applicable comment period, is available

for inspection in the TSCA Nonconfidential Information Center, North

East Mall Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC.

The Center is open from noon to 4 p.m., Monday through Friday,

excluding legal

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holidays. The telephone number for the Center is (202) 260-7099.

C. How and to Whom Do I Submit Comments?

You may submit comments through the mail, in person, or

electronically. To ensure proper receipt by EPA, it is imperative that

you identify docket control number OPPTS-50635 in the subject line on

the first page of your response.

1. By mail. Submit your comments to: Document Control Office

(7407), Office of Pollution Prevention and Toxics (OPPT), Environmental

Protection Agency, 401 M St., SW., Washington, DC 20460.

2. In person or by courier. Deliver your comments to: OPPT Document

Control Office (DCO) in East Tower Rm. G-099, Waterside Mall, 401 M

St., SW., Washington, DC. The DCO is open from 8 a.m. to 4 p.m., Monday

through Friday, excluding legal holidays. The telephone number for the

DCO is (202) 260-7093.

3. Electronically. You may submit your comments electronically by

e-mail to: ``[email protected],'' or mail your computer disk to the

address identified above. Do not submit any information electronically

that you consider to be CBI. Electronic comments must be submitted as

an ASCII file avoiding the use of special characters and any form of

encryption. Comments will also be accepted on standard disks in

WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic

form must be identified by docket control number OPPTS-50635.

Electronic comments may also be filed online at many Federal Depository

Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

Do not submit any information electronically that you consider to

be CBI. You may claim information that you submit to EPA in response to

this document as CBI by marking any part or all of that information as

CBI. Information so marked will not be disclosed except in accordance

with procedures set forth in 40 CFR part 2. In addition to one complete

version of the comment that includes any information claimed as CBI, a

copy of the comment that does not contain the information claimed as

CBI must be submitted for inclusion in the public version of the

official record. Information not marked confidential will be included

in the public version of the official record without prior notice. If

you have any questions about CBI or the procedures for claiming CBI,

please consult the technical person identified in the ``FOR FURTHER

INFORMATION CONTACT.''

E. What Should I Consider as I Prepare My Comments for EPA?

We invite you to provide your views on the various options we

propose, new approaches we haven't considered, the potential impacts of

the various options (including possible unintended consequences), and

any data or information that you would like the Agency to consider

during the development of the final action. You may find the following

suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used

that support your views.

4. If you estimate potential burden or costs, explain how you

arrived at the estimate that you provide.

5. Provide specific examples to illustrate your concerns.

6. Offer alternative ways to improve the rule.

7. Make sure to submit your comments by the deadline in this

document.

8. To ensure proper receipt by EPA, be sure to identify the docket

control number assigned to this action in the subject line on the first

page of your response. You may also provide the name, date, and Federal

II. Background

A. What Action is the Agency Taking?

This SNUR will require persons to notify EPA at least 90 days

before commencing manufacturing, importing, or processing a substance

for any activity designated by this SNUR as a significant new use. The

supporting rationale and background to this rule are more fully set out

in the preamble to EPA's first direct final SNUR published in the

Federal Register of April 24, 1990 (55 FR 17376). Consult that preamble

for further information on the objectives, rationale, and procedures

for the rules and on the basis for significant new use designations

including provisions for developing test data.

B. What is the Agency's Authority for Taking this Action?

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to

determine that a use of a chemical substance is a ``significant new

use.'' EPA must make this determination by rule after considering all

relevant factors, including those listed in section 5(a)(2) of TSCA.

Once EPA determines that a use of a chemical substance is a significant

new use, section 5(a)(1)(B) of TSCA requires persons to submit a notice

to EPA at least 90 days before they manufacture, import, or process the

substance for that use. The mechanism for reporting under this

requirement is established under 40 CFR 721.5.

C. Applicability of General Provisions

General provisions for SNURs appear under subpart A of 40 CFR part

721. These provisions describe persons subject to the rule,

recordkeeping requirements, exemptions to reporting requirements, and

applicability of the rule to uses occurring before the effective date

of the final rule. Provisions relating to user fees appear at 40 CFR

part 700. Persons subject to this SNUR must comply with the same notice

requirements and EPA regulatory procedures as submitters of PMNs under

section 5(a)(1)(A) of TSCA. In particular, these requirements include

the information submission requirements of TSCA section 5(b) and

5(d)(1), the exemptions authorized by TSCA section 5 (h)(1), (h)(2),

(h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA

receives a SNUR notice, EPA may take regulatory action under TSCA

section 5(e), 5(f), 6, or 7 to control the activities on which it has

received the SNUR notice. If EPA does not take action, EPA is required

under TSCA section 5(g) to explain in the Federal Register its reasons

for not taking action.

Persons who intend to export a substance identified in a proposed

or final SNUR are subject to the export notification provisions of TSCA

section 12(b). The regulations that interpret TSCA section 12(b) appear

at 40 CFR part 707. Persons who intend to import a chemical substance

identified in a final SNUR are subject to the TSCA section 13 import

certification requirements, which are codified at 19 CFR 12.118 through

12.127 and 127.28. Such persons must certify that they are in

compliance with SNUR requirements. The EPA policy in support of the

import certification appears at 40 CFR part 707.

III. Substances Subject to this Rule

EPA is establishing significant new use and recordkeeping

requirements for the following chemical substances under 40 CFR part

721, subpart E. In this unit, EPA provides a brief description for each

substance, including its PMN number, chemical name (generic name if the

specific name is claimed as CBI), CAS number (if assigned for non-

confidential chemical

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identities), basis for the action taken by EPA in the TSCA section 5(e)

consent order or as a non-section 5(e) SNUR for the substance

(including the statutory citation and specific finding), toxicity

concern, and the CFR citation assigned in the regulatory text section

of this rule. The specific uses which are designated as significant new

uses are cited in the regulatory text section of this document by

reference to 40 CFR part 721, subpart E where the significant new uses

are described in detail. Certain new uses, including production limits

and other uses designated in the rule are claimed as CBI. The procedure

for obtaining confidential information is set out in Unit VII. of this

preamble.

Where the underlying TSCA section 5(e) consent order prohibits the

PMN submitter from exceeding a specified production limit without

performing specific tests to determine the health or environmental

effects of a substance, the tests are described in this unit. As

explained further in Unit VI. of this preamble, the SNUR for such

substances contains the same production limit, and exceeding the

production limit is defined as a significant new use. Persons who

intend to exceed the production limit must notify the Agency by

submitting a significant new use notice (SNUN) at least 90 days in

advance. In addition, this unit describes tests that are recommended by

EPA to provide sufficient information to evaluate the substance, but

for which no production limit has been established in the TSCA section

5(e) consent order. Descriptions of recommended tests are provided for

informational purposes.

Data on potential exposures or releases of the substances, testing

other than that specified in the TSCA section 5(e) consent order for

the substances, or studies on analogous substances, which may

demonstrate that the significant new uses being reported do not present

an unreasonable risk, may be included with significant new use

notification. Persons submitting a SNUN must comply with the same

notice requirements and EPA regulatory procedures as submitters of

PMNs, as stated in 40 CFR 721.1(c), including submission of test data

on health and environmental effects as described in 40 CFR 720.50.

EPA is not publishing SNURs for PMNs P-97-991, P-97-342/343/344, P-

97-727/728/730/731/732/904, P-98-123, P-98-325, P-98-359, P-98-700/701,

and P-98-796, which are subject to a final TSCA section 5(e) consent

order. The TSCA section 5(e) consent orders for these substances are

derived from an exposure finding based solely on substantial production

volume and significant or substantial human exposure and/or release to

the environment of substantial quantities. For these cases there were

limited or no toxicity data available for the PMN substances. In such

cases, EPA regulates the new chemical substances under TSCA section

5(e) by requiring certain toxicity tests. For instance, chemical

substances with potentially substantial releases to surface waters

would be subject to toxicity testing of aquatic organisms and chemicals

with potentially substantial human exposures would be subject to health

effects testing for mutagenicity, acute effects, and subchronic

effects. However, for these substances, the short-term toxicity testing

required by the TSCA section 5(e) consent order is usually completed

within 1 to 2 years of notice of commencement. EPA's experience with

exposure-based SNURs requiring short-term testing is that the SNUR is

often revoked within 1 to 2 years when the test results are received.

Rather than issue and revoke SNURs in such a short span of time, EPA

will defer publication of exposure-based SNURs until either a notice of

commencement (NOC) or data demonstrating risk are received unless the

toxicity testing required is long-term. EPA is issuing this explanation

and notification as required in 40 CFR 721.160(a)(2) as it has

determined that SNURs are not needed at this time for these substances

which are subject to a final section 5(e) consent order under TSCA.

PMN Number P-90-1527

Chemical name: (generic) Halogenated benzyl ester acrylate.

CAS number: Not available.

Effective date of section 5(e) consent order: July 20, l998.

Basis for section 5(e) consent order: The order was issued under

section 5(e)(1)(A)(i) and section 5(e)(1)(A)(ii)(I) of TSCA based on a

finding that this substance may present an unreasonable risk of injury

to human health and the environment.

Toxicity concern: The PMN substance has been shown to cause kidney and

blood effects in test animals. Also, similar chemicals have been shown

to form dibenzodioxins and dibenzofurans when incinerated under

combustion conditions of municipal incinerators.

Recommended testing: A 90-day subchronic oral study in rats (40 CFR

798.2650 or OPPTS 870.3100 test guideline) is required to help

characterize systemic effects observed in shorter term testing. An

incineration simulation study is required to help characterize the

potential for the formation of dibenzodioxins or dibenzofurans when

plastics or resins containing the PMN substance are incinerated. The

consent order contains two production volume limits. The PMN submitter

has agreed not to exceed the first production volume limit without

performing the 90-day subchronic oral study. The PMN submitter has also

agreed not to exceed the second higher production volume limit without

performing an incineration simulation test.

CFR citation: 40 CFR 721.329.

PMN Numbers P-94-697 through P-94-895

Chemical name: (generic) Fatty acids C12-18, C18

unsaturated, C12-18 alkyl esters.

CAS number: Not available.

Effective date of section 5(e) consent order: October 6, 1994.

Basis for section 5(e) consent order: The order was issued under

section 5(e)(1)(A)(i) and section 5(e)(1)(A)(ii)(II) of TSCA based on a

finding that these substances are expected to be produced in

substantial quantities, there may be significant or substantial human

exposure to the substances, and the substances may enter the

environment in substantial quantities.

Recommended testing: EPA has determined that a 28-day oral toxicity

study in rats (Organization for Economic Cooperation and Development

(OECD) guideline no. 407) that includes a neurotoxicity functional

observational battery (National Technical Information Service (NTIS):

PB 91-154617) for all test doses with the highest dose set at 1,000

milligram/kilogram (mg/kg), and for the highest test dose group only,

histopathologic examination shall be extended to include testes/ovaries

and lungs, and an oral developmental toxicity study in one species (40

CFR 798.4900 or OPPTS 870.3700 test guideline) would help to

characterize the health effects of the substances. EPA has determined

that a ``modified Semicontinuous Activated Sludge (SCAS) test'' (OPPTS

835.3210 test guideline) and a ready biodegradation study (OPPTS

835.3110 test guideline) would help to characterize the environmental

effects of the substances. The PMN submitter has agreed not to exceed

the production volume limit without performing the toxicity studies

using P-94-697 and the biodegradation studies using P-94-697.

CFR citation: 40 CFR 721.3025.

PMN Number P-95-169

Chemical name: Morpholine, 4-(1-oxo-2-propenyl)-.

CAS number: 5117-12-4.

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Effective date of section 5(e) consent order: November 27, 1998.

Basis for section 5(e) consent order: The order was issued under

section 5(e)(1)(A)(i) and section 5(e)(l)(A)(ii)(I) of TSCA based on a

finding that this substance may present an unreasonable risk of injury

to health and the environment.

Toxicity concern: Structurally similar chemicals have been shown to

cause heritable mutagenicity, carcinogenicity, neurotoxicity,

reproductive toxicity, developmental toxicity, and systemic toxicity in

test animals and chronic aquatic toxicity in aquatic organisms.

Recommended testing: The consent order contains four production volume

limits. The PMN submitter has agreed not to exceed the first production

volume limit without performing an OECD guideline no. 422 study

extended to 90 days with observations for motor activity and

neuropathology (NTIS: PB91-154617) within 1 year from the commencement

of commercial manufacture or import to address the systemic,

developmental, and neurotoxic effects. The PMN submitter has also

agreed not to exceed the second higher production volume limit without

performing a rodent dominant lethal assay (40 CFR 798.5450 or OPPTS

870.5450 test guideline) 14 weeks before manufacturing or importing

1,300,000 kilograms of the PMN substance. If the rodent dominant lethal

assay is positive, the PMN submitter has also agreed not to exceed the

third higher production volume limit without performing a rodent

heritable translocation test (40 CFR 798.5460 or OPPTS 870.5460 test

guideline) which would be the appropriate follow-up test and it must be

submitted to EPA 14 weeks before manufacturing or importing 1,600,000

kilograms of the PMN substance or 1 year after the submission of the

rodent dominant lethal assay to EPA, whichever comes later to help

characterize the heritable mutagenic effects. The PMN submitter has

also agreed not to exceed the fourth higher production volume limit

without performing a 2-year, two-species oral carcinogenicity test (40

CFR 798.3300 or OPPTS 870.4200 test guideline) in rats and mice 14

weeks before manufacturing or importing an additional 4,000,000

kilograms of the PMN substance (a total of 5,500,000 kilograms) or 5

years after the commencement of commercial manufacture, whichever comes

later to help characterize the carcinogenic effects.

The following additional information would be required to evaluate

the environmental effects which may be caused by the PMN substance:

daphnid chronic toxicity study (40 CFR 797.1330 or OPPTS 850.1300 test

guideline (public draft)), a fish early life stage toxicity (40 CFR

797.1600 or OPPTS 850.1400 test guideline (public draft)), and a semi-

continuous activated sludge study (OPPTS 835.3210 test guideline). The

order does not require submission of the above information at any

specified time or production volume. However, the order's restrictions

on manufacture, import, processing, distribution in commerce, use, and

disposal of the PMN substance will remain in effect until the order is

modified or revoked by EPA based on submission of that or other

relevant information.

CFR citation: 40 CFR 721.5185.

PMN Numbers P-95-1400 and P-95-1410

Chemical names: (generic) (P-95-1400) Perfluorinatedalkyl

polyhydroxysilane; and (P-95-1410) Perfluorinatedalkyl

polyalkoxysilane.

CAS number: Not available.

Effective date of section 5(e) consent order: May 15, l998.

Basis for section 5(e) consent order: The order was issued under

section 5(e)(1)(A)(i) and section 5(e)(l)(A)(ii)(I) of TSCA based on a

finding that this substance may present an unreasonable risk of injury

to human health.

Toxicity concern: Based on submitted acute inhalation toxicity data

with 10 percent formulations of PMN P-95-1400 containing

hexadecyltrimethyl ammonium chloride, and sodium dodecylbenzene

sulfonate as emulsifiers, P-95-1400 has been shown to cause death in

test animals at concentrations as low as 61 milligrams per cubic meter.

Recommended testing: EPA has determined that a 90-day subchronic

inhalation study in rats (40 CFR 799.9346 or OPPTS 870.3465 test

guideline) would help to characterize a lethality risk to consumers

exposed via inhalation during use of these PMN substances.

CFR citations: 40 CFR 721.9508 (P-95-1400); 40 CFR 721.9509 (P-95-

1410).

PMN Number P-97-482

Chemical name: Fatty acids, C10-13 - branched, vinyl esters.

CAS number: 184785-38-4.

Effective date of section 5(e) consent order: July 31, 1998.

Basis for section 5(e) consent order: The order was issued under

section 5(e)(1)(A)(i) and section 5(e)(1)(A)(ii)(I) of TSCA based on a

finding that this substance may present an unreasonable risk of injury

to human health and the environment.

Toxicity concern: Structurally similar chemicals have been shown to

cause developmental and reproductive toxicity, neurotoxicity and cancer

in test animals, and chronic toxicity to aquatic organisms.

Recommended testing: A metabolic hydrolysis test on both the PMN

substance and the structural analogue vinyl acetate, as well as a 90-

day oral subchronic neurotoxicity testing in rats (OPPTS 870.3150 test

guideline), with certain adjuncts to address reproductive toxicity

concerns, will help the Agency to characterize the human health effects

of the PMN substance. The PMN submitter has agreed not to exceed the

production volume limit without performing these studies. The PMN

submitter has submitted testing on the PMN substance to characterize

environmental toxicity concerns.

CFR citation: 40 CFR 721.9965.

PMN Number P-97-635

Chemical name: Boric acid (H3BO3), mixed esters with polyethylene

glycol mono-Bu ether and polyethylene glycol mono Me ether.

CAS number: 183290-62-2.

Basis for action: This PMN substance will be used as a component of a

brake fluid formulation. EPA has identified health concerns for

reproductive and blood toxicity based on data on structurally similar

borons. Since significant worker exposure is unlikely when workers wear

impervious gloves, as described in the PMN, EPA has not determined that

the proposed processing and use of the substance may present an

unreasonable risk. EPA has determined, however, that manufacture,

process, or use of the substance without dermal protection may result

in serious chronic and developmental effects. Also, based on analogy to

boron, EPA is concerned that toxicity to aquatic organisms may occur at

a concentration as low as 300 parts per billion (ppb) of the PMN

substance in surface waters. Since environmental releases are not

expected to exceed 300 ppb as described in the PMN, EPA has not

determined that the proposed processing and use of the substance may

present an unreasonable risk. EPA has determined, however, that any

release of the PMN substance to surface water above 300 ppb may cause

significant adverse environmental effects. Based on this information,

the PMN substance meets the concern criteria at Sec. 721.170 (b)(3)(ii)

and (b)(4)(ii).

Recommended testing: EPA has determined that the OECD reproductive

toxicity screen in rats (OECD guideline

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no. 421) with special attention to hematology would help to

characterize the human health effects. If this screen is positive for

reproductive toxicity, a reproductive fertility study in rats (40 CFR

799.9380) is recommended. In addition, the following acute aquatic

toxicity tests: algal (40 CFR 797.1050 or OPPTS 850.5400 test guideline

(public draft)); daphnid (40 CFR 797.1300 or OPPTS 850.1010 test

guideline (public)); and fish (40 CFR 797.1400 or OPPTS 850.1075 test

guideline (public draft)) would help to characterize the environmental

effects of the PMN substances.

CFR citation: 40 CFR 721.1729.

PMN Number P-97-636

Chemical name: Poly(oxy-1,2-ethanediyl), -butyl--

hydroxy, ester with boric acid (H3BO3).

CAS number: 106008-93-9.