[Federal Register Volume 62, Number 125 (Monday, June 30, 1997)]
[Rules and Regulations]
[Pages 35103-35105]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17175]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 766 and 799

[OPPTS-40030; FRL-5728-5]


Technical Amendments to Test Rules and Enforceable Testing 
Consent Agreements/Testing Consent Orders

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA has approved by letter certain modifications to test 
standards and schedules for chemical testing programs under section 4 
of the Toxic Substances Control Act (TSCA). These modifications, 
requested by test sponsors, will be incorporated in the respective test 
rules or enforceable testing consent agreements/testing consent orders. 
Because these modifications do not significantly alter the scope of a 
test or significantly change the schedule for its completion, EPA 
approved these requests without seeking public notice and comment. EPA 
annually publishes a rule describing all of the modifications granted 
by letter for the previous year.

DATES: This rule is effective June 30, 1997.

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

SUPPLEMENTARY INFORMATION: EPA published a rule in the Federal Register 
of September 1, 1989 (54 FR 36311) amending procedures in 40 CFR part 
790 for modifying test standards and schedules for test rules and 
enforceable testing consent agreements/testing consent orders under 
section 4 of TSCA.
    The amended procedures allow EPA to approve requested modifications 
which do not alter the scope of a test or significantly change the 
schedule for its completion. These modifications are approved by letter 
without public notice and comment. The rule also requires immediate 
placement of these letters in the public record and publication of 
these modifications in the Federal Register. This rule includes 
modifications approved from January 1, 1996, through December 31, 1996. 
For a detailed description of the rationale for these modifications and 
for the correspondence relating to specific chemical test 
modifications, refer to the public record for the appropriate chemical 
substance or to the public record for this rulemaking (OPPTS-40030).

I. Discussion of Modifications

    Each chemical substance discussed in this rule is identified by a 
specific CAS number and docket control number. The following table 
lists all chemical-specific modifications approved from January 1, 
1996, through December 31, 1996.

[[Page 35104]]



        Modifications to Test Standards and Enforceable Testing Consent Agreements/Testing Consent Orders       
                                  (January 1, 1996, Through December 31, 1996)                                  
----------------------------------------------------------------------------------------------------------------
      Chemical name/CAS No.          CFR Cite            Test              Modifications      Docket control No.
----------------------------------------------------------------------------------------------------------------
Final rules:                                                                                                    
  Drinking Water Contaminants:                                                                                  
    1,1,2,2-Tetrachloroethane/CAS     799.5075   14-day oral subacute  5...................  40030/42111C       
     No. 79-34-5                                  testing.                                                      
  Polyhalogenated Dibenzo-para-                                                                                 
   Dioxins/Dibenzofurans                                                                                        
   (Dioxins/Furans):                                                                                            
    Chloranil (2,3,5,6-               Part 766   Analytical testing..  5...................  40030/40028/83002M 
     tetrachloro-2,5-                                                                                           
     cyclohexadiene-1,4-dione/CAS                                                                               
     No. 118-75-2                                                                                               
Enforceable Testing Agreements/                                                                                 
 Orders:                                                                                                        
  Alkyl Glycidyl Ethers (AGEs):                                                                                 
    Alkyl Glycidyl Ether (AGE C12-    799.5000   90-day subchronic     5...................  40030/42185        
     C13)/CAS No.120547-52-6                      dermal toxicity                                               
                                                  study.                                                        
                                                 Neurotoxicity:                                                 
                                                   Dermal subchronic   5                                        
                                                  functional                                                    
                                                  observational                                                 
                                                  battery.                                                      
                                                   Dermal subchronic   5                                        
                                                  motor activity.                                               
                                                   Dermal subchronic   5                                        
                                                  neuropathology.                                               
                                                   Dermal subchronic   5                                        
                                                  electrophysiology.                                            
                                                 Developmental         5                                        
                                                  toxicity study.                                               
                                                 Genetic toxicity                                               
                                                  studies:                                                      
                                                   Micronucleus assay  5                                        
                                                   Gene mutation in    5                                        
                                                  stomatic cells in                                             
                                                  culture.                                                      
                                                   Reveise mutation    5                                        
                                                  assay.                                                        
                                                 Change in required    2                                        
                                                  purity of test                                                
                                                  substance.                                                    
  Cyclohexane/CAS No. 110-82-7        799.5000   90-day subchronic     5...................  40030/42094C       
                                                  inhalation toxicity  9                                        
                                                  test in rats.        5                                        
                                                 Developmental                                                  
                                                  toxicity test                                                 
                                                  standard in rats.                                             
                                                 Developmental                                                  
                                                  toxicity studies in                                           
                                                  rats and rabbits.                                             
  Tertiary Amyl Methyl Ether          799.5000   Pharmacokinetics      5...................  40030/42180        
   (TAME), CAS No.      994-05-8                  study.               5                                        
                                                 90-day subchronic     5                                        
                                                  study.               5,11                                     
                                                 Neurotoxicity screen  5                                        
                                                 Reproductive                                                   
                                                  inhalation study.                                             
                                                 Developmental                                                  
                                                  toxicity study.                                               
----------------------------------------------------------------------------------------------------------------


    Modifications:
    1. Modify sampling schedule.
    2. Change test substance (form/purity).
    3. Change non-critical test procedure or condition.
    4. Add satellite group for further testing.
    5. Extend test or protocol deadline, delete test initiation 
date.
    6. Clarify and/or add specific guideline requirement.
    7. Alter specific guideline requirement approved for certain 
test(s).
    8. Correct CAS No.
    9. Amend test standard.
    10. Neurotoxicity endpoint rule.
    11. Revise protocol.

    Note: Only modifications under numbers 2, 5, 9, and 11 in the 
above table were approved in 1996.

II. Public Record

    EPA has established a public record for this rulemaking under 
docket control number OPPTS-40030. The record is available for 
inspection from 12 noon to 4 p.m., Monday through Friday, excluding 
legal holidays, in the TSCA Nonconfidential Information Center, 
Environmental Protection Agency, Rm. NE B-607, 401 M St., SW., 
Washington, DC 20460. Requests for documents should be sent in writing 
to: Fax: (202) 260-5069 or e-mail: [email protected].

III. Regulatory Assessment Requirements

A. Waiver of Notice of Proposed Rulemaking and Delay of Effective Date

    Because the test rule schedule modifications codified in this rule 
have no substantive effect on any person, EPA finds that public notice 
and comment are unnecessary. Thus, this rule may be promulgated without 
prior opportunity for public notice and comment pursuant to the 
Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)), and may be made 
effective upon publication in the Federal Register, without a 30-day 
delay, pursuant to 5 U.S.C. 553(d)(3).

B. Executive Order 12866

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), it has 
been determined that this action is not ``significant'' pursuant to the 
terms of this Executive Order because the modifications to the subject 
testing actions do not impose any additional requirements on the 
public. This action is therefore not subject to review by the Office of 
Management and Budget (OMB).

C. Regulatory Flexibility Act

    Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), I 
hereby certify that this action will not have a significant economic 
impact on a substantial number of small entities because the 
modifications referenced in this rule do not alter the scope of any 
test required under a test rule or significantly change the reporting 
schedule for any test rule.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub. 
L. 104-4, establishes requirements for Federal agencies to assess the 
effects of certain regulatory actions on State, local, and tribal 
governments and the private sector, and to seek input from State, 
local, and tribal governments on certain regulatory actions. EPA has 
determined that this action does not contain a Federal mandate that may

[[Page 35105]]

result in expenditures of $100 million or more for State, local, and 
tribal governments, in the aggregate, or the private sector in any 1 
year. No costs are imposed by this rulemaking since these test rule 
modifications only make non-significant changes to the reporting 
schedules for test rules. Therefore, this action is not subject to the 
requirements of section 202 and 205 of UMRA. The requirements of 
sections 203 and 204 of UMRA which relate to regulatory requirements 
that might significantly or uniquely affect small governments and to 
regulatory proposals that contain a significant Federal 
intergovernmental mandate, respectively, also do not apply to this rule 
because the rule affects only the private sector, i.e., those companies 
that test chemicals.

E. Paperwork Reduction Act

    The information collection requirements associated with this rule 
have been approved by OMB under the provisions of the Paperwork 
Reduction Act, 44 U.S.C. 350l et seq., and have been assigned OMB 
control number 2070-0033 (EPA ICR No. 1139). EPA has determined that 
this rule does not change existing recordkeeping or reporting 
requirements nor does it impose any additional recordkeeping or 
reporting requirements on the public.

F. 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, EPA 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 the rule in this 
Federal Register. This rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Parts 766 and 799

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

    Dated: June 25, 1997.

Susan H. Wayland,

Acting Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

    Therefore, 40 CFR chapter I is amended as follows:

PART 766--[AMENDED]

    1. In part 766:
    a. The authority citation for part 766 continues to read as 
follows:
    Authority: 15 U.S.C. 2603 and 2607.


    b. In Sec. 766.35, by adding an entry in numerical order by ``CAS 
No.'' to the table in paragraph (b)(4)(i) to read as follows:


 Sec. 766.35  Reporting requirements.

      *        *        *        *        *
    (b)      *      *      *
    (4)      *      *      *
    (i)      *      *      *

                                                                                                                
----------------------------------------------------------------------------------------------------------------
            CAS No.                   Submitter          Chemical name           Due date        Effective Date 
----------------------------------------------------------------------------------------------------------------
                                                                                                                
                             *        *        *        *        *        *        *                            
118-75-2.......................  Rhone-Poulenc Inc.  2,3,5,6-tetrachloro-   July 5, 1996.....  June 30, 1997    
                                                      2,5-cyclohexadiene-                                       
                                                      1,4-dione.                                                
                                                                                                                
                             *        *        *        *        *        *        *                            
----------------------------------------------------------------------------------------------------------------

      *        *        *        *        *

PART 799--[AMENDED]

    2. In part 799:
    a. The authority citation for part 799 continues to read as 
follows:
    Authority: 15 U.S.C. 2603, 2611, 2625.


    b. In Sec. 799.5075, by revising paragraphs (c)(1)(ii)(A) and (d) 
to read as follows:
      *        *        *        *        *


 Sec. 799.5075  Drinking water contaminants subject to testing.

      *        *        *        *        *
    (c)      *      *      *
    (1)      *      *      *
    (ii)      *      *      *
    (A) Each subacute test shall be completed and the final report 
submitted to EPA within 12 months of the date specified in paragraph 
(d)(1) of this section, except for 1,1,2,2-tetrachloroethane. The 
subacute testing for 1,1,2,2-tetrachloroethane shall be completed and 
the final report submitted to EPA by February 15, 1996.
      *        *        *        *        *
    (d) Effective date. (1) This section is effective on December 27, 
1993, except for paragraphs (a)(1), (a)(2), (c)(1)(i)(A), 
(c)(1)(ii)(A), (c)(1)(ii)(B), (c)(2)(i)(A), and (c)(2)(ii)(A). The 
effective date for paragraphs (a)(2), (c)(1)(ii)(B), and (c)(2)(ii)(A) 
is September 29, 1995. The effective date for paragraphs (a)(1), 
(c)(1)(i)(A), and (c)(2)(i)(A) is February 27, 1996. The effective date 
for paragraph (c)(1)(ii)(A) is June 30, 1997.
    (2) The guidelines and other test methods cited in this section are 
referenced as they exist on the effective date of the final rule.
[FR Doc. 97-17175 Filed 6-27-97; 8:45 am]
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