[Federal Register Volume 62, Number 191 (Thursday, October 2, 1997)]
[Rules and Regulations]
[Pages 51606-51608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-26189]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50625B; FRL-5744-6]
RIN 2070-AB27
Revocation of Significant New Use Rules for Certain Acrylate
Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is revoking significant new use rules (SNURs) promulgated
under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 95
substances based on new toxicity data. Based on the new data the Agency
no longer finds that activities not described in the TSCA section 5(e)
consent order may result in significant changes in human exposure.
DATES: This rule is effective November 3, 1997.
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.,
[[Page 51607]]
Washington, DC 20460, telephone: (202) 554-1404, TDD: (202) 554-0551;
e-mail: TSCA-Hotline@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register referenced for each
substance, OPPTS-50581A, October 31, 1990 (55 FR 46001); OPPTS- 50582,
August 15, 1990 (55 FR 33303); OPPTS-50583, August 9, 1990 (55 FR
32414); OPPTS-50585, September 28, 1990 (55 FR 39899); OPPTS-50587A,
June 5, 1991 (56 FR 25988); OPPTS-50591, April 25, 1991 (56 FR 19238);
OPPTS-50592, August 13, 1991 (56 FR 40212); OPPTS-50601, September 23,
1992 (57 FR 44070); OPPTS-50603, July 20, 1992 (57 FR 31969); OPPTS-
50608, June 8, 1993 (58 FR 32236); OPPTS-50612, October 4, 1993 (58 FR
51681); OPPTS-50613, October 4, 1993 (58 FR 51706); OPPTS-50615, May
27, 1994 (59 FR 27483); and OPPTS-50620, March 1, 1995 (60 FR 11042)
(FRL-4868-4); EPA issued a SNUR establishing significant new uses for
certain acrylate substances. Because of additional data EPA has
received for this chemical class, EPA is revoking these SNURs.
I. Background
The Agency proposed the revocation of these SNURs in the Federal
Register of June 2, 1997 (62 FR 29688) (FRL-5595-1). The background and
reasons for the revocation of the SNURs including a description of the
test data results are set forth in the preamble to the proposed
revocation. The comment period closed on August 14, 1997. In addition,
one of the SNURs that does not pertain to an acrylate substance (40 CFR
721.7780) was inadvertently included in the proposed revocation. As the
test data which is the basis for these revocations does not apply to
the substance which is described in 40 CFR 721.7780 the substance will
not be included in the final revocation, and EPA will take no further
action until new information is received for that substance.
The Agency received four comments concerning the proposed
revocation. Three comments supported revocation of the SNURs and urged
final revocation as quickly as possible.
One commenter objected to revoking any SNURs for substances
containing Bisphenol A; this was based on the demonstrated estrogenic
properties of Bisphenol A and its potential effects at low exposure
levels. EPA shares the commenter's concerns for estrogenic effects of
Bisphenol A and structurally similar chemicals. The potential
estrogenic effects of Bisphenol A and structurally similar chemicals is
one of the toxicity concerns EPA considers when reviewing new chemicals
under section 5(a) of TSCA. EPA recently required a premanufacture
notice submitter to submit an estrogen screening study for their PMN
substance under section 5(e)(1)(A)(ii)(II) of TSCA. The screening study
demonstrated no estrogenic activity.
EPA will continue to require testing where appropriate, for
substances that may demonstrate estrogenic effects, under section 5(e)
of TSCA. Given the current lack of data and the uncertainty in
selecting the appropriate tests to screen for estrogenic effects, the
EPA at this time cannot draw any general conclusions about the
potential estrogenic effects of substances of significantly higher
molecular weight than Bisphenol A.
The substances cited by the commenter are all polymeric materials
that utilize Bisphenol A as one of the starting materials. However,
EPA's new chemical review and regulatory findings under section 5(a) of
TSCA focus on the new chemical substance itself, rather than its
starting components. In addition, the types of exposures cited by the
commenter, leaching of Bisphenol A from food packaging or dental
sealants, are not regulated by TSCA but come instead under the
jurisdiction of the Federal Food, Drug, and Cosmetic Act.
Based on the acrylate test data cited in the proposal and the
comments received, EPA is still unable to conclude that the activities
defined as ``significant new uses'' in these SNURS may result in
significant changes in human exposure. Therefore, EPA is revoking these
rules.
II. Rationale for Revocation of the Rule
During review of the PMNs submitted for the chemical substances
that are the subject of this revocation, EPA concluded that regulation
was warranted based on the available information that indicated
activities not described in the section 5(e) consent order might result
in significant changes in human exposure. Based on these findings,
SNURs were promulgated.
EPA will revoke the section 5(e) consent orders that are the bases
for these SNURs because EPA has determined that it can no longer
support a finding that activities not described in the section 5(e)
consent order may result in significant changes in human exposure. The
revocation of SNUR provisions for these substances designated herein is
consistent with this finding.
In light of the above, EPA is revoking the SNUR provisions for
these chemical substances. When this revocation becomes final, EPA will
no longer require notice of any company's intent to manufacture,
import, or process these substances. In addition, export notification
under section 12(b) of TSCA will no longer be required.
III. Public Record
The official record for this rulemaking, as well as the public
version, has been established for this rulemaking under docket number
OPPTS-50625B (including comments and data submitted electronically). A
public version of this record, including printed, paper versions of
electronic comments, which does not include any information claimed as
confidential business information (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.
IV. Regulatory Assessment
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
[[Page 51608]]
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 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 materials,
Recordkeeping and reporting requirements.
Dated: September 24, 1997.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, 40 CFR part 721 is amended as follows:
PART 721--[AMENDED]
1. The authority citation for part 721 continues to read as
follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
Secs. 721.325, 721.370, 721.390, 721.400, 721.415, 721.460, 721.470,
721.490, 721.1175, 721.1575, 721.2050, 721.2170, 721.2650, 721.2750,
721.2930, 721.3028, 721.3120, 721.3640, 721.3870, 721.4020, 721.4220,
721.4400, 721.4780, 721.4790, 721.4800, 721.5705, 721.5910, 721.6500,
721.6580, 721.6640, 721.6700, 721.6720, 721.6740, 721.6760, 721.6780,
721.6840, 721.6880, 721.6940, 721.6960, 721.7040, 721.7080, 721.7100,
721.7140, 721.7180, 721.7240, 721.7300, 721.7320, 721.7340, 721.7370,
721.7400, 721.7420, 721.7460, 721.7540, 721.7560, 721.7580, 721.7660,
721.7680, 721.7740, 721.7760, 721.8075, 721.8265, 721.8275, 721.8290,
721.8300, 721.8325, 721.8335, 721.8375, 721.8400, 721.8425, 721.8475,
721.8525, 721.8550, 721.8575, 721.8600, 721.8650, 721.9240, 721.9320,
721.9360, 721.9420, 721.9510, 721.9525, 721.9870, 721.9940, 721.9975
[Removed]
2. By removing Secs. 721.325, 721.370, 721.390, 721.400, 721.415,
721.460, 721.470, 721.490, 721.1175, 721.1575, 721.2050, 721.2170,
721.2650, 721.2750, 721.2930, 721.3028, 721.3120, 721.3640, 721.3870,
721.4020, 721.4220, 721.4400, 721.4780, 721.4790, 721.4800, 721.5705,
721.5910, 721.6500, 721.6580, 721.6640, 721.6700, 721.6720, 721.6740,
721.6760, 721.6780, 721.6840, 721.6880, 721.6940, 721.6960, 721.7040,
721.7080, 721.7100, 721.7140, 721.7180, 721.7240, 721.7300, 721.7320,
721.7340, 721.7370, 721.7400, 721.7420, 721.7460, 721.7540, 721.7560,
721.7580, 721.7660, 721.7680, 721.7740, 721.7760, 721.8075, 721.8265,
721.8275, 721.8290, 721.8300, 721.8325, 721.8335, 721.8375, 721.8400,
721.8425, 721.8475, 721.8525, 721.8550, 721.8575, 721.8600, 721.8650,
721.9240, 721.9320, 721.9360, 721.9420, 721.9510, 721.9525, 721.9870,
721.9940, and 721.9975.
[FR Doc. 97-26189 Filed 10-1-97; 8:45 am]
BILLING CODE 6560-50-F
