[Federal Register Volume 60, Number 17 (Thursday, January 26, 1995)]
[Rules and Regulations]
[Pages 5138-5141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1856]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799
[OPPTS-42178; FRL-4925-9]
RIN 2070-AB94
Testing Consent Order for Glycidyl Methacrylate
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final Consent Agreement and Order; Final Rule.
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SUMMARY: EPA has issued a Testing Consent Order (Order) that
incorporates an Enforceable Consent Agreement (ECA) pursuant to the
Toxic Substances Control Act (TSCA) with Air Products and Chemicals,
Inc., The Dow Chemical Company, Mitsubishi Gas Chemical America, Inc.,
NOF America Corporation, and San Esters Corporation (the Companies).
The Companies have agreed to perform certain health effects tests on
glycidyl methacrylate (GMA; CAS No. 106-91-2). This document summarizes
the ECA, adds GMA to the list of chemical substances and mixtures
subject to testing consent orders, and announces that export
notification requirements apply to GMA.
EFFECTIVE DATE: January 26, 1995.
FOR FURTHER INFORMATION CONTACT: Jim Willis, Acting Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Rm. E-543B, 401 M St., SW., Washington, DC
20460, (202) 554-1404, TDD (202) 554-0551.
SUPPLEMENTARY INFORMATION: This document amends 40 CFR 799.5000 by
adding GMA to the list of chemical substances and mixtures subject to
testing consent orders and export notification requirements.
I. Background
GMA, a glycidol derivative, is an epoxy resin additive used in
paint coating formulations and adhesive applications. Its annual
production volume is less than 5 million pounds. Approximately 42,000
workers may be exposed to GMA.
In its third report to the EPA Administrator, published in the
Federal Register on October 30, 1978 (43 FR 50630), the Interagency
Testing Committee (ITC) designated the category of glycidol and its
derivatives [[Page 5139]] (collectively referred to as ``glycidyls'')
for priority consideration for health effects testing with regard to
the following endpoints: carcinogenicity, mutagenicity, teratogenicity,
and other adverse health effects, with particular emphasis on the
reproductive system. Epidemiological studies were also recommended. The
rationale for the original designation is discussed in the same Federal
Register notice. This chemical category was defined by the ITC as all
substances with the general formula:
[GRAPHIC][TIFF OMITTED]TR26JA95.022
where R is a hydrogen atom or any alkyl, aryl, or acyl group. R is
unrestricted as to the number and type of substituents it may carry.
On December 30, 1983, EPA published an advance notice of proposed
rulemaking (ANPR) in the Federal Register (48 FR 57562) to require
testing glycidyls under section 4(a) of TSCA.
In the November 7, 1991 Federal Register (56 FR 57144), EPA
published the Notice of Proposed Rulemaking for Glycidol and its
Derivatives. EPA evaluated the testing needs for glycidyls as described
in Unit I.D. of the Notice of Proposed Rulemaking for Glycidol and its
Derivatives. In this notice, EPA proposed that GMA manufacturers test
GMA for subchronic toxicity, developmental toxicity, and subchronic
neurotoxicity (functional observation battery, motor activity, and
neuropathology). Mutagenicity testing (a sex-linked recessive lethal
assay and a rodent dominant lethal assay) was proposed for glycidyl
acrylate as a representative test substance for Subgroup VII-B of the
glycidyls, of which GMA was the other member.
II. Enforceable Consent Agreement Negotiations
On July 17, 1992, EPA published a Federal Register notice (57 FR
31714) announcing an ``open season.'' The ``open season'' was a time
during which manufacturers could submit to EPA proposals for testing
chemical substances which had been proposed for testing by EPA but had
not been subject to a final test rule. In that notice, EPA indicated
that it would review the submissions and select candidates for
negotiation of ECAs pursuant to 40 CFR part 790. EPA also indicated
that it would later publish a Federal Register notice soliciting
persons interested in participating in or monitoring negotiations for
the development of ECAs on the chemical substances selected.
On September 15, 1992, the Companies submitted a proposal for
testing GMA under an ECA (Ref. 1). The Companies proposed subchronic
toxicity testing (including an evaluation of male reproductive
function), subchronic neurotoxicity testing (functional observational
battery, motor activity, neuropathology, and electrophysiology), and
reproductive toxicity testing.
On March 30, 1993, EPA published a Federal Register notice (58 FR
16669) establishing EPA's priority for initiating ECA negotiations on
certain chemical substances. The notice identified GMA as a Tier II
chemical substance for which some factors were considered favorable to
proceed towards negotiating an ECA. This notice and another Federal
Register notice (58 FR 19253, April 13, 1993) gave manufacturers the
opportunity to supplement their test proposals for Tier II chemical
substances, including GMA.
In response to the April 13, 1993 Federal Register notice, on April
26, 1993, the Companies submitted a supplement to their September 15,
1992 proposal (Ref. 2).
On August 18, 1993, EPA published a Federal Register notice (58 FR
43893) that solicited interested parties to participate in or monitor
ECA negotiations on GMA.
On November 18, 1993, the Companies submitted a draft proposed ECA
package for GMA (Ref. 3) that offered subchronic toxicity testing
(including an evaluation of male reproductive function), subchronic
neurotoxicity testing (functional observational battery, motor
activity, neuropathology, and electrophysiology), and developmental
toxicity testing.
EPA held a public meeting attended by representatives of the
Companies and other interested parties on July 27, 1994. During the
public meeting and following the meeting (Refs. 4, 5, and 6), consensus
was reached on the tests to be included in the ECA (See Table 1,
``Required Testing, Test Standards and Reporting Requirements for
GMA'', below.).
On October 18, 1994, EPA received the ECA signed by the Companies.
On January 13, 1995, EPA's Assistant Administrator for Prevention,
Pesticides and Toxic Substances signed the ECA and accompanying Order.
III. Proposed Test Rule
EPA has decided not to finalize the proposed test rule for GMA
contained in the proposed test rule for the category glycidol and its
derivatives (56 FR 57144, November 7, 1991). EPA has instead reached
agreement with the companies that the GMA testing requirements in the
proposed rule will be met by implementing the ECA and Order, and that
the issuance of the ECA and Order constitutes final EPA action for
purposes of 5 U.S.C. 704. Should EPA in the future decide that it
requires additional data on GMA, the Agency will initiate a separate
action.
IV. Testing Program
Table 1 describes the required testing, test standards, and
reporting requirements for GMA under the ECA. This testing program will
allow EPA to further characterize the potential health hazards
resulting from exposure to GMA.
Table 1.--Required Testing, Test Standards and Reporting Requirements
for GMA
------------------------------------------------------------------------
Deadline for Interim
Description of Test Standard (40 Final Report\1\ Reports\2\
Tests CFR citation) Months Required Number
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90 Day Subchronic (Appendix I.) 24 3
Toxicity Study
(Inhalation in
rats).
Functional (Appendix II.) 24 3
Observation
Battery:
Subchronic
(Inhalation in
rats).
Motor Activity (Appendix II.) 24 3
Test: Subchronic
(Inhalation in
rats).
Neuropathology: (Appendix II) 24 3
Subchronic
(Inhalation in
rats).
Functional 798.6050 12\4\ 1
Observation
Battery: Acute
(Inhalation in
rats)\3\.
Motor Activity 798.6200 12\4\ 1
Test: Acute
(Inhalation in
rats)\3\.
Neuropathology: 798.6400 12\4\ 1
Acute
(Inhalation in
rats)\3\.
Developmental (Appendix III.) 15 2
Toxicity
(Inhalation in
New Zealand
White Rabbits).
Mutagenicity:....
[[Page 5140]]
In vivo 798.5385 OR 24 3
Mammalian Bone 798.5395
Marrow
Cytogenetics
Analysis--IP
OR In vivo
Mammalian Bone
Marrow
Cytogenetics
Test:
Micronucleus
Assay--IP.
Gene Mutations 798.5300 10 1
in Somatic
Cells in
Culture.
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\1\ Number of months after the effective date of the consent order.
\2\ Interim reports are required every 6 months from the effective date
until the final report is submitted. This column shows the number of
interim reports required for each test.
\3\ If EPA determines that the results of the subchronic neurotoxicity
studies are not negative, then the acute neurotoxicity studies must be
performed.
\4\ Figure indicates the reporting deadline, in months, calculated from
the date of notification to the test sponsor by certified letter or
Federal Register notice that the Agency has determined this required
testing must be performed.
V. Export Notification
The issuance of the ECA and Order subjects any persons who export
or intend to export the chemical substance GMA (CAS No. 106-91-2), of
any purity, to the export notification requirements of section 12(b) of
TSCA. The listing of a chemical substance or mixture at 40 CFR 799.5000
serves as notification to persons who export or intend to export such
chemical substance or mixture that the substance or mixture is the
subject of an ECA and Order and that 40 CFR part 707 applies.
VI. Public Record
EPA has established a record for this ECA and Order under docket
number OPPTS-42178, which is available for inspection Monday through
Friday, excluding legal holidays, in Rm. NE B607, 401 M St., SW.,
Washington, DC, 20460 from Noon to 4 p.m. Information claimed as
Confidential Business Information (CBI), while part of the record, is
not available for public review. This record contains the basic
information considered in developing this ECA and Order, and consists
of the following information:
A. Supporting Documentation
(1) Testing Consent Order for GMA, with incorporated Enforceable
Consent Agreement and associated testing protocols attached as
appendices.
(2) Federal Register notices pertaining to this notice, the Testing
Consent Order and the Enforceable Consent Agreement, consisting of:
(a) ``Third Report of the Interagency Testing Committee; Receipt of
the Report and Request for Comments'' (43 FR 50630, October 30, 1978).
(b) Advance Notice of Proposed Rulemaking for Glycidol and its
Derivatives (48 FR 57562, December 30, 1983).
(c) Notice of Proposed Rulemaking for Glycidol and its Derivatives
(56 FR 57144, November 7, 1991).
(d) Notice of Opportunity to Initiate Negotiations for TSCA Section
4 Testing Consent Agreements (57 FR 31714, July 17, 1992).
(e) Notice of Testing Consent Agreement Development for Tier I
Chemical Substances; Solicitation for Interested Parties (58 FR 16669,
March 30, 1993).
(f) Notice of Testing Consent Agreement Development for Tiers II
and III Chemical Substances; Reopening of Comment Period (58 FR 19253,
April 13, 1993).
(g) Notice of Testing Consent Agreement Development for Listed
Chemical Substances; Solicitation for Interested Parties (58 FR 43893,
August 18, 1993).
(3) Communications consisting of:
(a) Written Letters.
(b) Telephone contact reports.
(c) Meeting summaries.
(4) Reports - published and unpublished factual materials.
B. References
1. Glycidyl Methacrylate Manufacturers Group. Letter from
Patrick J. Hurd to Gary E. Timm. Proposed Testing Program for
Glycidyl Methacrylate. Washington, DC. (September 15, 1992).
2. Glycidyl Methacrylate Industry Group. Letter from Patrick J.
Hurd to TSCA Public Docket Office. Supplement to Glycidyl
Methacrylate Testing Proposal. Washington, DC. (April 26, 1993).
3. Glycidyl Methacrylate Industry Group. Letter from Patrick J.
Hurd to Charles M. Auer. Draft Enforceable Consent Agreement
Proposal for Glycidyl Methacrylate. Washington, DC. (November 18,
1993).
4. EPA. Memorandum from Deborah O. Norris to Charles M. Auer.
Use of Subchronic Neurotoxicity Testing as a Trigger for Acute
Testing as Suggested by Industry Panel on GMA. Washington, DC.
(August 4, 1994).
5. Glycidyl Methacrylate Industry Group. Letter from Patrick J.
Hurd to Charles M. Auer. Use of Acute Tests and Subchronic
Neurotoxicity Testing as Triggers for Acute Neurotoxicity Testing.
Washington, DC. (September 1, 1994).
6. EPA. Letter from Charles M. Auer to Patrick J. Hurd. Glycidyl
Methacrylate Enforceable Consent Agreement; Final Draft for Test
Sponsors' Signatures. Washington, DC. (September 28, 1994).
VII. Regulatory Assessment Requirements
The Office of Management and Budget (OMB) has approved the
information collection requirements contained in the ECA under the
provisions of the Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et
seq., and has assigned OMB control 2070-0033.
Public reporting burden for this collection of information is
estimated to average 586 hours per response. The estimates include time
for reviewing instructions, searching existing data sources, gathering
and maintaining the data needed, and completing and reviewing the
collection of information.
List of Subjects in 40 CFR Part 799
Chemicals, Chemical export, Environmental protection, Hazardous
substances, Health effects, Laboratories, Reporting and recordkeeping
requirements, Testing.
Dated: January 13, 1995.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
Therefore, 40 CFR chapter I, subchapter R, part 799 is amended as
follows:
PART 799--[AMENDED]
1. The authority citation for part 799 continues to read as
follows:
Authority: 15 U.S.C. 2603, 2611, 2625.
2. Section 799.5000 is amended by adding glycidyl methacrylate to
the table in CAS Number order, to read as follows:
Sec. 799.5000 Testing Consent Orders for Substances and Mixtures with
Chemical Abstract Service Registry Numbers.
* * * * * *
[[Page 5141]]
------------------------------------------------------------------------
Substance or mixture FR Publication
CAS Number name Testing Date
------------------------------------------------------------------------
* * * *
* * *
106-91-2........ Glycidyl Health effects January 26,
Methacrylate 1995
* * * *
* * *
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[FR Doc. 95-1856 Filed 1-25-95; 8:45 am]
BILLING CODE 6560-50-F
