[Federal Register Volume 59, Number 222 (Friday, November 18, 1994)]
[Unknown Section]
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From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-28552]
[[Page Unknown]]
[Federal Register: November 18, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799
[OPPTS-42094C; FRL-4909-5]
RIN 2070-AB94
Testing Consent Order for Cyclohexane
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final Consent Agreement and Order.
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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 Chevron Chemical Company,
CITGO Refining Chemicals, Inc., Sun Company, Inc., Kerr-McGee Refining
Corporation, Huntsman Corporation, E.I. DuPont de Nemours Company, and
Phillips Petroleum Company, (the Companies) who have agreed to perform
certain health effects tests and an exposure evaluation test with
cyclohexane (CAS No. 110-82-7). This document summarizes the ECA, and
amends 40 CFR 799.5000 by adding cyclohexane to the list of chemical
substances and mixtures subject to ECAs.
EFFECTIVE DATE: November 18, 1994.
FOR FURTHER INFORMATION CONTACT: Susan Hazen, 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 cyclohexane to the list of chemical substances and mixtures
subject to ECAs and export notification requirements.
I. Background
In its 17th Report to the Administrator of the Environmental
Protection Agency, published in the Federal Register of November 19,
1985 (50 FR 47603), the Interagency Testing Committee (ITC) designated
cyclohexane for priority testing consideration for certain health
effects testing. The ITC recommended cyclohexane for testing for
oncogenicity, reproductive toxicity, developmental toxicity, and
neurotoxicity. The rationale for the original designation appeared in
that Report. In the Federal Register of May 20, 1987 (52 FR 19096), EPA
issued a proposed test rule for cyclohexane for health effects testing.
EPA proposed cyclohexane be tested for subchronic toxicity,
oncogenicity, reproductive toxicity, developmental toxicity,
neurotoxicity (schedule-controlled operant behavior, neuropathology,
functional observation battery, and motor activity), developmental
neurotoxicity, dermal absorption, and dermal sensitization.
On July 17, 1992, EPA published a notice in the Federal Register
(57 FR 31714) declaring an ``open season'' for consent order
negotiations for certain chemicals under testing consideration by EPA
under section 4 of TSCA. These chemicals included cyclohexane. In a
proposal dated September 15, 1992, the Cyclohexane Panel of the
Chemical Manufacturers Association submitted a proposal for testing
cyclohexane for potential health effects (Ref. 1). The Cyclohexane
Panel's proposal included virtually all of EPA's proposed testing
except for oncogenicity testing and developmental neurotoxicity. The
Panel did not propose to do a developmental neurotoxicity test,
believing it to be unwarranted due to data showing limited exposure.
EPA disagrees with the Panel's ultimate conclusions on this testing and
believes that such testing is supported by the exposure data. However,
EPA also believes that this testing would best be considered after EPA
receives and reviews the results of the neurotoxicity, reproductive and
fertility tests required under the ECA described in this notice.
In accordance with 40 CFR 790.28, EPA issued an additional notice
in the Federal Register of March 30, 1993 (58 FR 16669) announcing a
public meeting and EPA's intent to negotiate with industry for a
Testing Consent Order for cyclohexane based on the acceptance of the
Cyclohexane Panel's proposal as an adequate basis for negotiation. EPA
published notices in the Federal Register of March 30, 1993 (58 FR
16669) and August 18, 1993 (58 FR 43893), requesting persons interested
in participating in or monitoring testing negotiations on cyclohexane
to contact EPA.
On February 17, 1994, EPA held a public meeting attended by
representatives of interested parties. At the public meeting, the
Cyclohexane Panel of CMA presented a proposed testing plan (Ref. 2)
which would characterize the potential of cyclohexane's subchronic
toxicity, reproductive toxicity, developmental toxicity, neurotoxicity
(schedule-controlled operant behavior, neuropathology, functional
observation battery, and motor activity), dermal absorption, and dermal
sensitization. The Panel did not think that oncogenicity testing of
cyclohexane was warranted at this time. EPA responded by noting the
large emissions of cyclohexane reported on the Toxic Release Inventory
(TRI). These emissions were reported by processors and users of
cyclohexane, whereas the manufacturers reported relatively smaller
releases. EPA requested that the manufacturers consider implementing,
as part of their product stewardship activities, an emissions reduction
program on cyclohexane targeted at their customers. In a letter dated
March 17, 1994 (Ref. 3), CMA proposed language for an emissions
reduction provision to be inserted into the ECA. In a letter dated
April 14, 1994 (Ref. 4), EPA responded by agreeing to defer
oncogenicity testing pending prospective reductions in cyclohexane
emissions. This provision provides that within 3 months after
submission of the last study report required under the ECA, the
Companies will submit a report to EPA summarizing the then current data
on environmental releases of cyclohexane from facilities that
manufacture, process or use cyclohexane. Upon reviewing the emissions
data report submitted after completion of testing, as well as data from
testing performed under this ECA, and other available exposure/
emissions information, EPA may revisit the issue of the need for
oncogenicity testing of cyclohexane.
II. Exposure and Environmental Releases
Approximately 2.4 billion pounds of cyclohexane was produced in
1989. Over 95 percent of cyclohexane produced is used as an
intermediate in nylon production. EPA's best estimate of the number of
workers occupationally exposed to cyclohexane is 12,076. Cyclohexane is
found in a number of consumer products including spray paint and spray
adhesives and is also available as a laboratory solvent. Toxic Release
Inventory data indicate that about 17.2 million pounds of cyclohexane
was released to the environment in 1991.
III. Scope of Testing Program
The Companies have agreed to complete the following testing.
Table--Required Testing, Test Standards and Reporting Requirements for
Cyclohexane
------------------------------------------------------------------------
Reporting
Test standard (40 deadline for Interim reports
Test CFR citation) final report\1\ (6 month)
(months) required
------------------------------------------------------------------------
Health Effects...
Subchronic: 40 CFR 798.2450 21 3
inhalation.
Reproductive
effects.
Inhalation..... 40 CFR 798.4700 29 4
Developmental
toxicity.
Inhalation..... 40 CFR 798.4350 15 2
Schedule-
controlled
operant behavior.
Acute 1991 EPA 15 2
inhalation. Guideline
Functional
observational
battery.
Subchronic 1991 EPA 21 3
inhalation. Guideline for
neurotoxicity
screening
battery
Motor activity...
Subchronic 1991 EPA 21 3
inhalation. Guideline for
neurotoxicity
screening
battery
Neuropathology...
Subchronic 1991 EPA 21 3
inhalation. Guideline for
neurotoxicity
screening
battery
Dermal
sensitization.
Dermal......... 40 CFR 798.4100 12 1
Dermal absorption
test.
Dermal and Jeffcoat protocol 12 1
intravenous.
------------------------------------------------------------------------
\1\ Number of months after the effective date of the final rule.
In addition, the Companies have agreed that within 3 months
following submission of the last study report required under this ECA,
the Companies will submit a report to EPA summarizing the then current
data on environmental releases of cyclohexane from facilities that
manufacture, process or use cyclohexane.
IV. Export Notification
The issuance of the ECA and Order subjects any persons who export
or intend to export the chemical substance, cyclohexane (CAS No. 110-
82-7), of any purity, to the export notification requirements of
section 12(b) of TSCA and the regulations promulgated pursuant to it at
40 CFR part 707. The listing of the chemical substance or mixture at 40
CFR 799.5000 serves as a notification to persons who intend to export
such chemical substance or mixture that the substance or mixture is the
subject of an ECA and Order and 40 CFR part 707 applies.
V. Withdrawal of Proposed Rule
EPA and the Companies have agreed that the cyclohexane testing
requirements in the proposed rule will be met by implementing the Order
and ECA, and the issuance of the Order and ECA by EPA constitutes final
EPA action for purposes of 5 U.S.C. 704. Therefore, the proposed rule
for cyclohexane, published at 52 FR 19026, May 20, 1987, is withdrawn.
Any oncogenicity and developmental neurotoxicity testing requirements
will be handled in separate actions.
VI. Rulemaking Record
EPA has established a record for this Consent Order under TSCA
section 4, docket number OPPTS-42094C, which is available for
inspection Monday through Friday, excluding legal holidays, in Rm. NE
B607, 40l M St. SW., Washington, DC 20460 from 12 p.m. to 4 p.m.
Confidential Business Information (CBI) while part of the record, is
not available for public review. This record includes basic information
considered by EPA in developing this ECA and Order and includes the
following information:
(1) Testing Consent Order for Cyclohexane, with incorporated
Enforceable Consent Agreement and associated test standards attached as
appendices.
(2) Federal Register notices pertaining to this notice and the
Testing Consent Order incorporating the ECA and consisting of:
(a) Notice containing the ITC recommendation with intent to
designate cyclohexane (50 FR 47603; November 19, 1985).
(b) Notice of Proposed Rulemaking, Cyclohexane (52 FR 19096, May
20, 1987).
(c) Notice of Opportunity to Initiate Negotiations for TSCA Section
4 Testing Consent Agreements (57 FR 31714, July 17, 1992).
(d) Notice of Testing Consent Agreement Development for Tier I
Chemical Substances; Solicitation for Interested Parties (58 FR 16669,
March 30, 1993).
(e) 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) Contact reports of telephone summaries.
(c) Meeting summaries.
(4) Reports - published and unpublished factual materials.
B. References
(1) Chemical Manufacturers Association. Testing Proposal of the
Cyclohexane Panel of the Chemical Manufacturers Association.
September 15, 1992.
(2) Chemical Manufacturers Association. Letter to John Harris of
EPA dated February 16, 1994.
(3) Chemical Manufacturers Association. Letter to Charles Auer
of EPA dated March 17, 1994.
(4) EPA. Letter to Jonathon Busch of the Chemical Manufacturers
Association dated April 14, 1994.
VII. Regulatory Assessment Requirements
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to review by the Office of Management and Budget
(OMB)). Under section 3(f), the order defines ``significant regulatory
action'' as action that is likely to result in a rule (1) having an
annual effect on the economy of $100 million or more, or adversely and
materially affecting a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or State,
local or tribal governments or communities (also referred to as
``economically significant''); (2) creating serious inconsistency or
otherwise interfering with an action taken or planned by another
agency; (3) materially altering the budgetary impacts of entitlement,
grants, user fees, or loan programs; or (4) raising novel legal or
policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in this Executive Order.
OMB has exempted this regulatory action from E.O. 12866 review
because it is a consent agreement.
B. Paperwork Reduction
The Office of Management and Budget (OMB) has approved the
information collection requirements contained in this Order under the
provisions of the Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et
seq., and has assigned OMB control number 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 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: November 3, 1994.
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 continues to read as follows:
Authority: 15 U.S.C. 2603, 2611, 2625.
2. Section 799.5000 is amended by adding cyclohexane 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.
* * * * *
------------------------------------------------------------------------
Substance or FR Publication
CAS Number mixture name Testing Date
------------------------------------------------------------------------
* * * * * * *
110-82-7......... Cyclohexane...... Health Effects November 18,
and 1994
Environmental
Releases Report.
* * * * * * *
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[FR Doc. 94-28552 Filed 11-17-94; 8:45 am]
BILLING CODE 6560-50-F