[Federal Register Volume 59, Number 173 (Thursday, September 8, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-21688]


[[Page Unknown]]

[Federal Register: September 8, 1994]


-----------------------------------------------------------------------


ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 766 and 799

[OPPTS-40027; FRL-4873-4]

 

Technical Amendments to Test Rules and Consent Orders

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

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 and codified in the 
respective test regulation or consent order. 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 notice and comment. EPA annually 
publishes a notice describing all of the modifications granted by 
letter for the previous year.

EFFECTIVE DATE: This rule is effective on September 8, 1994.

FOR FURTHER INFORMATION CONTACT: Susan B. 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: EPA issued a rule published in the Federal 
Register of September 1, 1989 (54 FR 36311), amending procedures for 
modifying test standards and schedules for test rules and 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 (40 CFR 
790.55 and 790.68). These modifications are approved by letter without 
public comment. The rule also requires immediate placement of these 
letters in EPA's public files and publication of these modifications in 
the Federal Register. This document includes modifications approved 
from January 1, 1993, through December 31, 1993. For a detailed 
description of the rationale for these modifications, refer to the 
submitters' letters and EPA's responses in the public record for this 
rulemaking.

I. Discussion of Modifications

    Each chemical discussed in this rule is identified by a specific 
CAS number. Copies of correspondence relating to specific chemical 
modifications may be found in docket number OPPTS-40027 for this rule. 
The following table lists all chemical-specific modifications approved 
from January 1, 1993, through December 31, 1993: 

   Modifications to Test Standards and Consent Orders January 1, 1993   
                        Through December 31, 1993                       
------------------------------------------------------------------------
Chemical/CAS Number   Chemical                                          
                      FR Cite          Test             Modifications   
------------------------------------------------------------------------
Final Rule                                                              
 Chemicals.                                                             
  pentabromodipheny   766.35    analytical testing.  5                  
   loxide (32534-81-                                                    
   9).                                                                  
                                                                        
  octabromodiphenyl   766.35    analytical testing.  5                  
   oxide (32536-52-                                                     
   0).                                                                  
                                                                        
  1,2-                766.35    analytical testing.  5                  
   bis(tribromophen                                                     
   oxy)-ethane                                                          
   (37853-59-1).                                                        
                                                                        
  tetrabromobisphen   766.35    analytical testing.  5                  
   ol-A-                                                                
   bisethoxylate                                                        
   (4162-45-2).                                                         
                                                                        
  commercial hexane   799.2155  oncogenicity         5                  
   (110-54-3; 96-37-             (mouse).                               
   7).                                                                  
                                                                        
  acetone (67-64-1)   799.5050  neurotoxicity        10                 
                                 testing.                               
  n-amyl acetate,     799.5050  neurotoxicity        10                 
   technical grade               testing.                               
   (628-63-7).                                                          
  1-butanol (71-36-   799.5050  neurotoxicity        10                 
   3).                           testing.                               
  n-butyl acetate     799.5050  neurotoxicity        10                 
   (123-86-4).                   testing.                               
  diethyl ether (60-  799.5050  neurotoxicity        10                 
   29-7).                        testing.                               
  2-ethoxyethanol     799.5050  neurotoxicity        10                 
   (110-80-5).                   testing.                               
  ethyl acetate       799.5050  neurotoxicity        10                 
   (141-78-6).                   testing.                               
  isobutyl alcohol    799.5050  neurotoxicity        10                 
   (78-83-1).                    testing.                               
  methyl isobutyl     799.5050  neurotoxicity        10                 
   ketone (108-10-               testing.                               
   1).                                                                  
  tetrahydrofuran     799.5050  neurotoxicity        10                 
   (109-99-9).                   testing.                               
                                                                        
Consent Orders.....                                                     
  acrylic acid (79-   799.5000  bioavailability      5                  
   10-7).                        study.                                 
                                                                        
  4-                  799.5000  pharmacokinetics in  3, 5               
   vinylcyclohexene              vitro metabolism                       
   (100-40-3).                   in rat and mouse                       
                                 tissues; in vitro                      
                                 partition                              
                                 coefficient..                          
------------------------------------------------------------------------

Modifications
     1. Modify sampling schedule.
     2. Change to test substance (form/purity).
     3. Change in 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. Alternate specific guideline requirement approved for 
certain test(s).
     8. CAS No. correction.
     9. Test standard amendment.
    10. By letter to the affected manufacturers, EPA granted certain 
modifications to the Multi-substance Rule for the Testing of 
Neurotoxicity, 40 CFR 799.5050. Subsequently, however, the rule was 
challenged in court. As part of the settlement of that litigation, 
EPA agreed to propose to revoke this rule. EPA announced that 
pending revocation of the rule (59 FR 33187, June 27, 1994) and 
negotiation of enforceable consent agreements under which testing 
would be performed, the rule would be stayed (59 FR 33184, June 2, 
1994). Copies of the modifications that had been granted are 
available in docket number OPPTS-42134B. Anyone who believes they 
may be subject to the requirements of this test rule should contact 
Catherine Roman at 260-8155 regarding its status before initiating 
testing.

II. Public Record

    EPA has established a public record for this rulemaking (docket 
number OPPTS-40027). The record includes the requests for 
modifications, information considered by EPA in evaluating the 
requested modifications, and EPA's responses to the requests.
    The record is available for inspection from 12:00 noon to 4 p.m., 
Monday through Friday, except legal holidays, in Rm. NE-G607, 401 M 
St., SW., Washington, DC 20460.

III. Regulatory Assessment Requirements

A. 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 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.
    Send comments regarding the information collection requirements of 
this rule to Chief, Information Policy Branch, PM-223, U.S. 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; 
and to the Office of Information and Regulatory Affairs, Office of 
Management and Budget, Washington, DC 20503.

List of Subjects in 40 CFR Part 799

    Chemicals, Chemical export, Environmental protection, Hazardous 
substances, Recordkeeping and reporting Requirements, Testing.

    Dated: August 24, 1994.

Susan H. Wayland,

Acting Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

    Therefore, 40 CFR parts 766 and 799 are amended as follows:
    1. In part 766:

PART 766--[AMENDED]

    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 revising the following entries in the table 
to paragraph (b)(4)(i) and paragraph (f) to read as follows:


Sec. 766.35   Reporting requirements.

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


------------------------------------------------------------------------
     Cas No.           Submitter          Chemical          Due Date    
------------------------------------------------------------------------
                                                                        
                                 *******                                
4162-45-2........  Great Lakes        tetrabromobisphe  June 2,1993     
                                       nol-A-                           
                                       bisethoxylate                    
                                 *******                                
32534-81-9.......  Great Lakes        pentabromodiphen  March 22, 1993  
                                       yloxide                          
32534-81-9.......  Ameribrom          pentabromodiphen  March 22, 1993  
                                       yloxide                          
32536-52-0.......  Ameribrom          octabromodipheny  January 8, 1993 
                                       loxide                           
                                 *******                                
37853-59-1.......  Great Lakes        1,2-              January 31, 1993
                                       bis(tribromophe                  
                                       noxy)-ethane                     
------------------------------------------------------------------------

*   *   *   *   *
    (f) Effective date. (1) The effective date of this final rule is 
July 6, 1987, except for paragraphs (a)(2)(i)(B), (a)(2)(ii)(A) and 
(b)(4)(i) of this section.
    (2) The effective date for paragraph (a)(2)(i)(B) is May 21, 1991. 
The effective date for paragraph (a)(2)(ii)(A) is June 12, 1992. The 
effective date for paragraph (b)(4)(i) is on September 8, 1994.
    (3) The guidelines and other test methods cited in this rule are 
referenced as they exist on the effective date of the final rule.

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.  799.2155 by revising paragraphs (c)(2)(ii)(A) and (d) 
to read as follows:


Sec. 799.2155   Commercial Hexane.

*   *   *   *   *
    (c) * * *
    (2)* * *
    (ii) * * *
     (A) The oncogenicity test shall be completed and the final report 
submitted to EPA within 53 months of the effective date of the final 
rule. The mouse portion of the oncogenicity study shall be submitted by 
June 5, 1993.
*   *   *   *   *
    (d) Effective date. (1) The effective date of this final rule is 
November 17, 1988, except for the provisions of paragraphs 
(c)(2)(ii)(A), (c)(5)(i)(D), (c)(5)(ii)(A)(4), (c)(5)(ii)(C), (c)(8)(i) 
and (c)(8)(ii)(A) of this section. The effective date for paragraphs 
(c)(5)(i)(D), (c)(5)(ii)(A)(4) and (c)(5)(ii)(C) of this section is May 
21, 1990. The effective date for paragraphs (c)(8)(i) and (c)(8)(ii)(A) 
of this section is June 12,1992. The effective date of paragraph 
(c)(2)(ii)(A) is September 8, 1994.
    (2) The guidelines and other test methods cited in this rule are 
referenced as they exist on the effective date of the final rule.
[FR Doc. 94-21688 Filed 9-7-94; 8:45 am]
BILLING CODE 6560-50-F