[Code of Federal Regulations]
[Title 40, Volume 28]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR721.185]

[Page 174-175]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES--Table of Contents
 
 Subpart D--Expedited Process for Issuing Significant New Use Rules for 
 Selected Chemical Substances and Limitation or Revocation of Selected 
                        Significant New Use Rules
 
Sec. 721.185  Limitation or revocation of certain notification requirements.

    (a) Criteria for modification or revocation. EPA may at any time 
modify or revoke significant new use notification requirements for a 
chemical substance which has been added to subpart E of this part using 
the procedures under Sec. 721.160 or Sec. 721.170. Such action may be 
taken under this section if EPA makes one of the following 
determinations, unless other information shows that the requirements 
should be retained:
    (1) Test data or other information obtained by EPA provide a 
reasonable basis for concluding that activities designated as 
significant new uses of the substance will not present an unreasonable 
risk of injury to human health or the environment.
    (2) EPA has promulgated a rule under section 4 or 6 of the Act, or 
EPA or another agency has taken action under another law for the 
substance that eliminates the need for significant new use notification 
under section 5(a)(2) of the Act.
    (3) EPA has received significant new use notices for some or all of 
the activities designated as significant new uses of the substance and, 
after reviewing such notices, concluded that there is no need to require 
additional notice from persons who propose to engage in identical or 
similar activities.
    (4) EPA has examined new information, or has reexamined the test 
data or other information or analysis supporting its decision to add the 
substance to subpart E of this part under Sec. 721.170 and has concluded 
that the substance does not meet the criteria under Sec. 721.170(b).
    (5) For a substance added to subpart E of this part under 
Sec. 721.160, EPA has examined new information, or has reexamined the 
test data or other information or analysis supporting its finding under 
section 5(e)(1)(A)(ii)(I) of the Act, and has concluded that a rational 
basis no longer exists for the findings that activities involving the 
substance may present an unreasonable risk of injury to human health or 
the environment required under section 5(e)(1)(A) of the Act.
    (6) For a substance added to subpart E of this part under 
Sec. 721.160, certain activities involving the substance have been 
designated as significant new uses pending the completion of testing, 
and adequate test data developed in accordance with applicable 
procedures and criteria have been submitted to EPA.
    (b) Procedures for limitation or revocation. Modification or 
revocation of significant new use notification requirements for a 
substance that has been added to subpart E of this part using the 
procedures described under Sec. 721.160 or Sec. 721.170 may occur either 
at EPA's initiative or in response to a written request.
    (1) Any affected person may request modification or revocation of 
significant new use notification requirements for a substance that has 
been added to subpart E of this part using the procedures described in 
Sec. 721.160 or Sec. 721.170 by writing to the Director of the Office of 
Pollution Prevention and Toxics and stating the basis for such request. 
All

[[Page 175]]

requests should be sent to the Document Control Office (7407), Office of 
Pollution Prevention and Toxics, U.S. Environmental Protection Agency, 
Room G-099, 1200 Pennsylvania Ave., NW., Washington, DC 20460. ATTN: 
Request to amend significant new use rule. The request must be 
accompanied by information sufficient to support the request.
    (2) The Director of the Office of Pollution Prevention and Toxics 
will consider the request, make a determination whether to initiate 
rulemaking to modify the requirements, and notify the requester of that 
determination by certified letter. If the request is denied, the letter 
will explain why EPA has concluded that the significant new use 
notification requirements for that substance should remain in effect.
    (3) If EPA concludes that significant new use notification 
requirements for a substance should be limited or revoked, EPA will 
propose the changes in the Federal Register, briefly describe the 
grounds for the action, and provide interested parties an opportunity to 
comment.

[54 FR 31314, July 27, 1989, as amended at 58 FR 34204, June 23, 1993; 
60 FR 34464, July 3, 1995]