[Federal Register Volume 62, Number 236 (Tuesday, December 9, 1997)]
[Proposed Rules]
[Pages 64795-64799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32180]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[OPPTS-50629; FRL-5752-9]
RIN 2070-AB27


Proposed Revocation of Significant New Use Rules for Certain 
Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to revoke significant new use rules (SNURs) 
for 12 substances promulgated under section 5(a)(2) of the Toxic 
Substances Control Act (TSCA) for certain chemical substances based on 
new data. Based on the new data the Agency no longer finds that 
activities not described in the corresponding TSCA section 5(e) consent 
order or the premanufacture notice (PMN) for these chemical substances 
may result in significant changes in human or environmental exposure.
DATES: Written comments must be received by EPA by January 8, 1998.

ADDRESSES: Each comment must bear the docket control number OPPTS-50629 
and the name(s) of the chemical substance(s) subject to the comment. 
All comments should be sent in triplicate to: OPPT Document Control 
Officer (7407), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 401 M St., SW., Room G-099, East 
Tower, Washington, DC 20460.
    Comments and data may also be submitted electronically to: 
[email protected]. Follow the instructions under Unit III. of 
this document. No Confidential Business Information (CBI) should be 
submitted through e-mail.
    All comments which contain information claimed as CBI must be 
clearly marked as such. Three sanitized copies of any comments 
containing information claimed as CBI must also be submitted and will 
be placed in the public record for this rulemaking. Persons submitting 
information on any portion of which they believe is entitled to 
treatment as CBI by EPA must assert a business confidentiality claim in 
accordance with 40 CFR 2.203(b) for each portion. This claim must be 
made

[[Page 64796]]

at the time that the information is submitted to EPA. If a submitter 
does not assert a confidentiality claim at the time of submission, EPA 
will consider this as a waiver of any confidentiality claim and the 
information may be made available to the public by EPA without further 
notice to the submitter.

FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, 
Environmental Assistance Division (7408), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, Rm. E-543A, 401 
M St., SW., Washington, DC 20460, telephone: (202) 554-1404, TDD: (202) 
554-0551; e-mail: TSCA-H[email protected].

SUPPLEMENTARY INFORMATION:
Electronic Availability: Electronic copies of this document are 
available from the EPA Home Page at the Federal Register-Environmental 
Documents entry for this document under ``Laws and Regulations'' 
(http://www.epa.gov/ fedrgstr/).
    In the Federal Register referenced for each substance, EPA issued a 
SNUR establishing significant new uses for the substances listed in 
Unit II. of this preamble, OPPTS-50582, August 15, 1990 (55 FR 33303); 
OPPTS-50585, September 28, 1990 (55 FR 39899); OPPTS-50589, April 17, 
1991 (56 FR 15784); OPPTS-50601, September 23, 1992 (57 FR 44070); 
OPPTS-50613, October 4, 1993 (58 FR 51706); and OPPTS-50620, March 1, 
1995 (60 FR 11042) (FRL-4868-4). Because of additional data EPA has 
received for these substances, EPA is hereby proposing to revoke the 
SNURs.

I. Rationale for Revocation of the Rules

    During EPA's review of the PMNs submitted under section 5(a)(1)(A) 
of TSCA for the chemical substances subject to this revocation, EPA 
concluded that promulgation of SNURs under section 5(a)(2) was 
warranted based on the fact that activities not described in the 
section 5(e) consent order or the PMN might result in significant 
changes in human or environmental exposure. Based on these findings, 
SNURs were promulgated defining such activities as ``significant new 
uses.''
    Based on new data, EPA has revoked, or will revoke the section 5(e) 
consent orders that are the basis for these SNURs and no longer finds 
that activities not described in the section 5(e) consent orders or the 
PMN may result in significant changes in human or environmental 
exposure nor constitutes ``significant new uses.'' The proposed 
revocation of SNURs for these substances is consistent with this 
finding. When this revocation becomes final, notice of intent to 
manufacture, import, or process these substances for a significant new 
use will no longer be required. In addition, export notification under 
section 12(b) of TSCA will no longer be required on the basis of these 
substances being subject to SNURs.

II. Proposed Revocations and Background

    EPA is proposing to revoke the significant new use and 
recordkeeping requirements under 40 CFR part 721, subpart E for the 
following chemical substances. In this unit, EPA provides a description 
for each substance, including its premanufacture notice (PMN) number, 
chemical name (generic name if the specific name is claimed as CBI), 
CAS number (if assigned), the date of the revocation of the section 
5(e) consent order (where applicable), a summary of the reason for 
revoking the rule, Federal Register reference, docket number, and the 
CFR citation removed in the regulatory text section of this proposed 
rule. Further background information for the substances is contained in 
the rulemaking record referenced below in Unit III. of this preamble.

PMN Number P-87-90

Chemical name: (generic) Methylenebistrisubstituted aniline-.
CAS number: Not available.
Revocation of section 5(e) consent order: September 11, 1997.
Federal Register publication date and reference: August 15, 1990 (55 FR 
33305).
Docket number: OPPTS-50582.
Basis for revocation: Based on the Agency's analysis of potential 
exposures and the test data submitted pursuant to the section 5(e) 
consent order, EPA no longer finds that activities described as 
``significant new uses'' in the SNUR may result in significant changes 
in human exposure. Accordingly, EPA has determined that further 
regulation under section 5(a)(2) is not warranted at this time.
Toxicity results: 90-Day Dietary Study in Rats: Based on toxic effects 
in the liver and lungs to both males and females, the lowest observed 
adverse effect level (LOAEL) was 300 parts per million (ppm) (23.4 
milligrams/kilograms/day (mg/kg/day) and 28.2 mg/kg/day) and the no 
observed adverse effect level (NOAEL) was 100 ppm (7.6 mg/kg/day and 
8.5 mg/kg/day) respectively. There were no effects noted in the target 
areas of the eyes and the reproductive organs of the males or females. 
In addition, three mutagenicity studies, a mouse micronucleus assay, a 
bacterial mutation assay, and a chromosomal aberration study were 
conducted. The results demonstrated that the PMN substance is not a 
gene or chromosome mutagen and confirmed previous negative results in 
Salmonella typhimurium and in vitro in human lymphocytes.
CFR citation: 40 CFR 721.700 (Formerly 40 CFR 721.1395).

PMN Number P-91-55

Chemical name: (generic) Alkylcarbamic acid, alkynyl ester.
CAS number: Not available.
Revocation of section 5(e) consent order: March 11, 1997.
Federal Register publication date and reference: September 23, 1992 (57 
FR 44064).
Docket number: OPPTS-50601.
Basis for revocation: Based on the Agency's analysis of potential 
exposures and the test data submitted pursuant to the section 5(e) 
consent order, EPA no longer finds that activities described as 
``significant new uses'' in the SNUR may result in significant changes 
in human exposure. Accordingly, EPA has determined that further 
regulation under section 5(a)(2) is not warranted at this time.
Toxicity results: The following test data for structurally analogous 
material was submitted under the terms of the 5(e) consent order. The 
data showed the 96-hour LC50 for fish was 85.0 milligrams/
liter (mg/L) and the 48-hour LC50 for daphnids was 60.0 mg/
L.
CFR citation: 40 CFR 721.2840.

PMN Number P-84-527

Chemical name: (generic) Unsaturated amino ester salt.
CAS number: Not available.
Federal Register publication date and reference: August 15, 1990 (55 FR 
33304).
Docket number: OPPTS-50582.
Basis for revocation: Based on the Agency's analysis of the test data 
submitted under a voluntary testing program for acrylates, EPA no 
longer finds that activities described as ``significant new uses'' in 
the SNUR may result in significant changes in human exposure. 
Accordingly, EPA has determined that further regulation under section 
5(a)(2) is not warranted at this time.
Toxicity results: Two long-term dermal bioassays on triethylene glycol 
diacrylate and triethylene glycol dimethacrylate demonstrated no 
evidence of carcinogenicity under the test conditions. Refer to 
Proposed Revocation of SNURs for Certain Acrylate Substances published 
in the Federal Register of June 2, 1997 (62 FR

[[Page 64797]]

29688) (FRL-5595-1), for further background information on these test 
results.
CFR citation: 40 CFR 721.2860 (Formerly 40 CFR 721.980).

PMN Number P-84-537

Chemical name: (generic) Unsaturated amino alkyl ester salt.
CAS number: Not available.
Federal Register publication date and reference: August 15, 1990 (55 FR 
33304).
Docket number: OPPTS-50582.
Basis for revocation: Based on the Agency's analysis of the test data 
submitted under a voluntary testing program for acrylates, EPA no 
longer finds that activities described as ``significant new uses'' in 
the SNUR may result in significant changes in human exposure. 
Accordingly, EPA has determined that further regulation under section 
5(a)(2) is not warranted at this time.
Toxicity results: Two long-term dermal bioassays on triethylene glycol 
diacrylate and triethylene glycol dimethacrylate demonstrated no 
evidence of carcinogenicity under the test conditions. Refer to 
Proposed Revocation of SNURs for Certain Acrylate Substances published 
in the Federal Register of June 2, 1997 (62 FR 29688) (FRL-5595-1), for 
further background information on these test results.
CFR citation: 40 CFR 721.2880 (Formerly 40 CFR 721.983).

PMN Number P-90-549

Chemical name: (generic) Benzoate ester.
CAS number: Not available.
Federal Register publication date and reference: April 17, 1991 (56 FR 
15790).
Docket number: OPPTS-50589.
Basis for revocation: Based on the Agency's analysis of potential 
exposures and the test data submitted pursuant to the section 5(e) 
consent order, EPA no longer finds that activities described as 
``significant new uses'' in the SNUR may result in significant changes 
in human exposure. Accordingly, EPA has determined that further 
regulation under section 5(a)(2) is not warranted at this time.
Toxicity results: The substance is not a chromosome mutagen in vivo in 
the mouse micronucleus assay. The 28-day repeated dose oral study in 
rats demonstrated a NOAEL of 150 mg/kg/day and a LOAEL of 1,000 mg/kg/
day based on behavioral changes, liver effects, and blood effects. An 
oral developmental toxicity study in rats demonstrated a NOAEL of 300 
mg/kg/day for both maternal and developmental toxicity. At 1,000 mg/kg/
day there was both maternal body weight loss and a decrease in fetal 
weight in addition to reductions in the incidence of fetal 
ossification.
CFR citation: 40 CFR 721.2940 (Formerly 40 CFR 721.570).

PMN Numbers P-88-1303, P-88-2177, and P-90-212

Chemical name: Ethane, 1,1-dichloro-1-fluoro-.
CAS number: 1717-00-6.
Federal Register publication date and reference: April 17, 1991 (56 FR 
15791).
Docket number: OPPTS-50589.
Basis for revocation: Based on the Agency's analysis of potential 
exposures and the test data submitted pursuant to the section 5(e) 
consent order, EPA no longer finds that activities described as 
``significant new uses'' in the SNUR may result in significant changes 
in human exposure. Accordingly, EPA has determined that further 
regulation under section 5(a)(2) is not warranted at this time.
Toxicity results: Rat Inhalation Carcinogenicity Study: The only 
significant effects noted were a statistically significant increased 
incidence of benign testicular interstitial cell tumors in male rats in 
the mid and high dose ranges (5,000 ppm and 15,000-20,000 ppm). The 
high dose was \1/3\ of the 4-hour LC50. Two Generation 
Inhalation Reproductive Study: The substance demonstrated reproductive 
and developmental toxicity at 20,000 ppm. Adult systemic toxicity was 
evident at 8,000 ppm and 20,000 ppm. The LOAEL was 8,000 ppm and the 
NOAEL was 2,000 ppm. A Neurobehavioral and Neuropathological Effects 
Study in Rats: The only effect noted was a significant reduction in 
brain weight in females exposed to the highest concentration (rats were 
dosed at 15,000 ppm for 16 weeks and 2 days and observed for effects 
until week 21 of the study).
CFR citation: 40 CFR 721.3200 (Formerly 40 CFR 721.1007).

PMN Number P-89-776

Chemical name: (generic) Substituted benzenesulfonic acid, alkali metal 
salt.
CAS number: Not available.
Federal Register publication date and reference: April 17, 1991 (56 FR 
15790).
Docket number: OPPTS-50589.
Basis for revocation: Based on the Agency's analysis of potential 
exposures and the test data submitted pursuant to the section 5(e) 
consent order, EPA no longer finds that activities described as 
``significant new uses'' in the SNUR may result in significant changes 
in human exposure. Accordingly, EPA has determined that further 
regulation under section 5(a)(2) is not warranted at this time.
Toxicity results: The substance was not a chromosome mutagen in vivo in 
the mouse micronucleus assay. The no observed effect level (NOEL) for 
the 90-day oral study in rats is 50 mg/kg/day based on increased liver 
weights and clinical chemistry changes indicative of hepatotoxicity at 
316 mg/kg/day and higher.
CFR citation: 40 CFR 721.4640 (Formerly 40 CFR 721.566).

PMN Number P-86-1662

Chemical name: (generic) Halogenated phosphate ester.
CAS number: Not available.
Revocation of section 5(e) consent order: December 7, 1995.
Federal Register publication date and reference: October 4, 1993 (58 FR 
51707).
Docket number: OPPTS-50613.
Basis for revocation: Based on the Agency's analysis of potential 
exposures and the test data submitted pursuant to the section 5(e) 
consent order, EPA no longer finds that activities described as 
``significant new uses'' in the SNUR may result in significant changes 
in human exposure. Accordingly, EPA has determined that further 
regulation under section 5(a)(2) is not warranted at this time.
Toxicity results: An oral 28-day repeated dose neurotoxicity study in 
hens: An NOAEL of 1,000 mg/kg/day was established based on a decrease 
of brain neurotoxic esterase in the spinal cord and a NOEL of 500 mg/
kg/day was established based on no effects observed at this dose level 
(the next lower dose tested).
CFR citation: 40 CFR 721.5990.

PMN Number P-91-831

Chemical name: Propane, 1,1,1,2,3,3,3-heptafluoro-.
CAS number: 431-89-0.
Federal Register publication date and reference: September 23, 1992 (57 
FR 44071).
Docket number: OPPTS-50601.
Basis for revocation: Based on the Agency's analysis of potential 
exposures and the test data submitted pursuant to the section 5(e) 
consent order, EPA no longer finds that activities described as 
``significant new uses'' in the SNUR may result in significant changes 
in human exposure. Accordingly, EPA has determined that further 
regulation under section 5(a)(2) is not warranted at this time.
Toxicity results: Inhalation Developmental Toxicity Studies in Rats and 
Rabbits: No effects were noted at

[[Page 64798]]

100,000 ppm (the maximum dose tested) in rats or rabbits. No effects 
were noted in the rangefinding studies at 200,000 ppm. 90-day 
Inhalation Study in Rats: No effects noted at 78,167 ppm. Cardiac 
Sensitization Inhalation Study in dogs: The substance is a cardiac 
sensitizer at 14 percent concentration (140,000 ppm) in air. The NOAEL 
is estimated at 9.7 percent concentration in air based on no adverse 
effects noted at 9 percent concentration in air and distinctly 
irregular heartbeats noted at 10.5 percent concentration in air.
CFR citation: 40 CFR 721.8125.

PMN Number P-90-583

Chemical name: (generic) Reaction product of alkylphenol, tetraalkyl 
titanate and tin complex.
CAS number: Not available.
Revocation of section 5(e) consent order: May 31, 1995.
Federal Register publication date and reference: April 17, 1991 (56 FR 
15793).
Docket number: OPPTS-50589.
Basis for revocation: Based on the Agency's analysis of potential 
exposures and the test data submitted pursuant to the section 5(e) 
consent order, EPA no longer finds that activities described as 
``significant new uses'' in the SNUR may result in significant changes 
in human exposure. Accordingly, EPA has determined that further 
regulation under section 5(a)(2) is not warranted at this time.
Toxicity results: The acute oral LC50 is greater than 2,000 
mg/kg/day. The mouse micronucleus assay and the ames assay were 
negative. The 28-day repeated dose oral study in rats demonstrated a 
NOAEL of 150 mg/kg/day and a LOAEL of 1,000 mg/kg/day.
CFR citation: 40 CFR 721.9260 (Formerly 40 CFR 721.2085).

PMN Number P-89-844

Chemical name: 1,3,5-Triazine-2,4,6-triamine, hydrobromide.
CAS number: 29305-12-2.
Revocation of section 5(e) consent order: January 17, 1996.
Federal Register publication date and reference: September 28, 1990 (55 
FR 39905).
Docket number: OPPTS-50585.
Basis for revocation: Based on the Agency's analysis of potential 
exposures and the test data submitted pursuant to the section 5(e) 
consent order, EPA no longer finds that activities described as 
``significant new uses'' in the SNUR may result in significant changes 
in human exposure. Accordingly, EPA has determined that further 
regulation under section 5(a)(2) is not warranted at this time.
Toxicity results: A 1-generation oral (dietary) reproductive study in 
rats demonstrated a NOAEL of 1,600 ppm. At 4,000 ppm there was reduced 
maternal food consumption during lactation, reduced paternal body 
weight (bwt), and reduced offspring survival and bwt.
CFR citation: 40 CFR 721.9780 (Formerly 40 CFR 721.2188).

PMN Number P-94-1009

Chemical name: (generic) Trifunctional aliphatic blocked urethane 
cross-linker.
CAS number: Not available.
Federal Register publication date and reference: March 1, 1995 (60 FR 
11045).
Docket number: OPPTS-50620.
Basis for revocation: Pursuant to 40 CFR 720.75(e), the submitter 
withdrew the PMN. Therefore, a new PMN is required before anyone may 
commence manufacture or import. Since the PMN requirement is applicable 
to the substance, a SNUR is unwarranted at this time and EPA is 
revoking the SNUR.
CFR citation: 40 CFR 721.9962.

III. Public Record and Electronic Submissions

    The official record for this rulemaking, as well as the public 
version, has been established for this rulemaking under docket control 
number OPPTS-50629 (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as CBI, is available for inspection 
from 12 noon to 4 p.m., Monday through Friday, excluding legal 
holidays. The official rulemaking record is located in the TSCA 
Nonconfidential Information Center, Rm. NE-B607, 401 M St., SW., 
Washington, DC.
    Electronic comments can be sent directly to EPA at:
    [email protected]


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Comments and data 
will also be accepted on disks in WordPerfect 5.1/6.1 or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket control number OPPTS-50629. Electronic comments on this 
proposed rule may be filed online at many Federal Depository Libraries.

IV. Regulatory Assessment Requirements

    This final rule revokes or eliminates an existing regulatory 
requirement and does not contain any new or amended requirements. As 
such, the Office of Management and Budget (OMB) has exempted these 
types of actions from review under Executive Order 12866, entitled 
Regulatory Planning and Review (58 FR 51735, October 4, 1993). Since 
this final rule does not impose any requirements, it does not contain 
any information collections subject to approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or require any other 
action under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Pub. L. 104-4). Nor does it require any prior consultation as 
specified by Executive Order 12875, entitled ``Enhancing the 
Intergovernmental Partnership'' (58 FR 58093, October 28, 1993), or 
special considerations as required by Executive Order 12898, entitled 
Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994) 
or require OMB review in accordance with Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997).
    In addition, pursuant to section 605(b) of the Regulatory 
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency has determined 
that SNUR revocations, which eliminate requirements without imposing 
any new ones, have no adverse economic impacts. The Agency's generic 
certification for SNUR revocations appears on June 2, 1997 (62 FR 
29684) (FRL-5597-1), and was provided to the Chief Counsel for Advocacy 
of the Small Business Administration.

V. Submission to Congress and the General Accounting Office

    Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business 
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a 
report containing this rule and other required information to the U.S. 
Senate, the U.S. House of Representatives, and the Comptroller General 
of the General Accounting Office prior to publication of this proposed 
rule in today's Federal Register. This is not a major rule as defined 
by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: November 24, 1997.

Charles M. Auer,

Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.

    Therefore, it is proposed that 40 CFR part 721 be amended as 
follows:

[[Page 64799]]

PART 721--[AMENDED]

    1. The authority citation for part 721 would continue to read as 
follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

Sec. Sec. 721.700, 721.2840, 721.2860, 721.2880, 721.2940, 721.3200, 
721.4640, 721.5990, 721.8125, 721.9260, 721.9780, 721.9962   [Removed]

    2. By removing Sec. Sec. 721.700, 721.2840, 721.2860, 721.2880, 
721.2940, 721.3200, 721.4640, 721.5990, 721.8125, 721.9260, 721.9780, 
and 721.9962.

[FR Doc. 97-32180 Filed 12-8-97; 8:45 am]
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