[Code of Federal Regulations]
[Title 40, Volume 23]
[Revised as of July 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR155.53]

[Page 59-60]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 155_REGISTRATION STANDARDS AND REGISTRATION REVIEW--Table of Contents
 
                Subpart C_Registration Review Procedures
 
Sec. 155.53  Conduct of a pesticide's registration review.

    The Agency will review data and information described in Sec. 
155.50(a), (b), and (c) or submitted in response to a Data Call-In 
notice that it believes should be considered in the pesticide's 
registration review.
    (a) Assess changes since a pesticide's last review. The Agency will 
assess any changes that may have occurred since the Agency's last 
registration decision in order to determine the significance of such 
changes and whether the pesticide still satisfies the FIFRA standard for 
registration. The Agency will consider whether to conduct a new risk 
assessment to take into account, among other things, any changes in 
statutes or regulations, policy, risk assessment procedures or methods, 
or data requirements. The Agency will consider whether any new data or 
information on the pesticide, including any data or information 
submitted under Sec. 155.50 or in response to a Data Call-In notice, 
warrant conducting a new risk assessment or a new risk/benefit 
assessment. The Agency will also consider whether any new data or 
information regarding an individual pesticide product, including any 
data or information submitted under Sec. 155.50 or in response to a 
Data Call-In notice, such as data or information about an inert 
ingredient in the pesticide product or other information or data 
relating to the composition, labeling or use of the pesticide product, 
warrant additional review of a pesticide product's registration.
    (b) Conduct new assessments as needed. (1) Active ingredient(s) in 
the registration review case. If the Agency finds that a new assessment 
of the pesticide is needed, it will determine whether it can base the 
new assessment on available data or information, including data or 
information submitted under Sec. 155.50 or in response to a Data Call-
In notice. If sufficient data or information are available, the Agency 
will conduct the new risk assessment or risk/benefit assessment. If the 
Agency determines that additional data or information are needed to 
conduct the review, the Agency will issue a Data Call-In notice under 
FIFRA section 3(c)(2)(B).
    (2) Individual product registrations. If the Agency finds that 
additional review of an individual product's registration is needed, it 
will review the pesticide product label, confidential statement of 
formula, product-specific data, or other pertinent data or information, 
as appropriate, to determine whether the registration of the individual 
product meets the FIFRA standard for registration. If the Agency 
determines that additional data or information are needed to conduct the 
review, the Agency will issue a Data Call-In notice under FIFRA section 
3(c)(2)(B).
    (c) Public participation during a pesticide's registration review. 
The Agency will generally make available for public review and comment a 
draft risk assessment for a pesticide if a new risk assessment has been 
conducted. The Agency will publish a notice in the Federal Register 
announcing the availability of the draft risk assessment and provide a 
comment period of at least 30 calendar days. The Agency will publish a 
notice in the Federal Register announcing the availability of a revised 
risk assessment, an explanation of any changes to the proposed document, 
and its response to comments. If the revised risk assessment indicates 
risks of concern, the Agency may, in the notice announcing the 
availability of the revised risk assessment, provide a comment period of 
at least 30 calendar days for the public to submit suggestions for 
mitigating the risk identified in the revised risk assessment.
    (1) The Agency might not request comments on a draft risk assessment 
in cases where the Agency's initial screening of a pesticide indicates 
that it has low use/usage, affects few if any stakeholders or members of 
the public, poses low risk, and/or requires little or no risk 
mitigation. In such cases, the Agency will make a draft risk assessment 
available for public review and

[[Page 60]]

comment when it issues a proposed decision on the registration review 
case.
    (2) If the Agency finds that it is not necessary to conduct a new 
risk assessment, it will issue a proposed decision on the registration 
review case as described in Sec. 155.58.