[Federal Register Volume 59, Number 222 (Friday, November 18, 1994)]
[Unknown Section]
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From the Federal Register Online via the Government Printing 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