

[Federal Register: August 9, 2006 (Volume 71, Number 153)]
[Rules and Regulations]               
[Page 45719-45734]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09au06-29]                         


[[Page 45719]]

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

Part IV





 Environmental Protection Agency





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



40 CFR Parts 9 and 155



 Pesticides; Procedural Regulations for Registration Review; Final Rule


[[Page 45720]]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 155

[EPA-HQ-OPP-2004-0404; FRL-8080-4]
RIN 2070-AD29

 
Pesticides; Procedural Regulations for Registration Review

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This rule establishes procedures for conducting the pesticide 
registration review program mandated by the Federal Insecticide, 
Fungicide, and Rodenticide Act. Under this rule, EPA will review 
existing pesticide registrations to determine whether they continue to 
meet the statutory standard for registration. The registration review 
program will begin in the fall of 2006. This rule provides for the 
establishment of pesticide cases for review, the scheduling of reviews, 
the initiation, completion and documentation of reviews, and associated 
public participation procedures. The registration review program 
established by this regulation is intended to ensure that all pesticide 
registrations are systematically reviewed in a manner that is based on 
sound science and provides for public participation, transparency and 
efficiency to protect public health and the environment. In addition, 
in order to display the OMB control number for the information 
collection requirements contained in this final rule, EPA is amending 
the table of OMB approval numbers for EPA regulations.

DATES: This final rule is effective on October 10, 2006.

ADDRESSES: EPA has established a docket for this action under Docket 
identification (ID) number EPA-HQ-OPP-2004-0404. All documents in the 
docket are listed in the docket index at http://www.regulations.gov. 

Although listed in the index, some information is not publicly 
available, e.g., CBI or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the Office 

of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One 
Potomac Yard (South Bldg.), 2777 S. Crystal Drive, Arlington, VA. The 
hours of operation of this Docket Facility are from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The Docket 
Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Vivian Prunier, Field and External 
Affairs Division (7506P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: 703-308-9341; fax number: 703-305-5884; e-mail 
address: prunier.vivian@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you hold 
pesticide registrations. Pesticide users or other persons interested in 
the regulation of the sale, distribution or use of pesticides may also 
be interested in this procedural regulation. Potentially affected 
entities may include, but are not limited to:
     Producers of pesticide products (NAICS code 32532).
     Producers of antifoulant paints (NAICS code 32551).
     Producers of antimicrobial pesticides (NAICS code 32561).
     Producers of nitrogen stabilizer products (NAICS code 
32531).
     Producers of wood preservatives (NAICS code 32519).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in Sec.  155.40 of the 
rule. If you have any questions regarding the applicability of this 
action to a particular entity, consult the person listed under FOR 
FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using http://www.regulations.gov to access this 

document and other related information in the electronic docket, you 
may access this Federal Register document electronically through the 
EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/
.


II. Overview of this Document

    In this document, EPA presents its response to comments on the 
proposed rule to establish procedural regulations for the registration 
review of pesticides. In response to comments, EPA is modifying some 
aspects of the rule relating to procedures for public participation in 
the registration review process. The differences between the proposed 
rule and the final rule are described in Units VI. and X.
    In this document, the Agency describes:
     Statutory authority.
     History of this rulemaking.
     Response to comments on the rule.
     Response to comments on the operation and implementation 
of the program.
     Results of reviews required by statutes or executive 
orders.
     Changes to the rule.
     Procedural regulations for the registration review of 
pesticides.

III. Authority

A. EPA's Authority to License Pesticides

    FIFRA section 3(a) generally requires a person to register a 
pesticide product with the EPA before the pesticide product may be 
lawfully distributed or sold in the U.S. A pesticide registration is a 
license that allows a pesticide product to be distributed or sold for 
specific uses under specified terms and conditions. A pesticide product 
may be registered or remain registered only if it meets the statutory 
standard for registration given in FIFRA section 3(c)(5), as follows:

    (A) its composition is such as to warrant the proposed claims 
for it;
    (B) its labeling and other material required to be submitted 
comply with the requirements of this Act;
    (C) it will perform its intended function without unreasonable 
adverse effects on the environment; and
    (D) when used in accordance with widespread and commonly 
recognized practice it will not generally cause unreasonable adverse 
effects on the environment.

    FIFRA 2(bb) defines ``unreasonable adverse effects on the 
environment'' as

    (1) any unreasonable risk to man or the environment, taking into 
account the economic, social, and environmental costs and benefits 
of the use of any pesticide, or (2) a human dietary risk from 
residues that result from a use of a pesticide in or on any food 
inconsistent with the standard under section 408 of the Federal 
Food, Drug, and Cosmetic Act.

    The burden to demonstrate that a pesticide product satisfies the 
criteria for registration is at all times on the

[[Page 45721]]

proponents of initial or continued registration. (Industrial Union 
Dept. v. American Petroleum Institute, 448 U.S. 607, 653 n. 61 (1980); 
Environmental Defense Fund v. Environmental Protection Agency, 510 F.2d 
1292, 1297, 1302 (D.C. Cir. 1975).

B. EPA's Authority for Registration Review

    The Food Quality Protection Act (FQPA) of 1996 amended FIFRA to 
add, among other things, section 3(g), ``REGISTRATION REVIEW,'' as 
follows:

    (1)(A) GENERAL RULE. - The registrations of pesticides are to be 
periodically reviewed. The Administrator shall by regulation 
establish a procedure for accomplishing the periodic review of 
registrations. The goal of these regulations shall be a review of a 
pesticide's registration every 15 years. No registration shall be 
canceled as a result of the registration review process unless the 
Administrator follows the procedures and substantive requirements of 
section 6.
    (B) LIMITATION. - Nothing in this subsection shall prohibit the 
Administrator from undertaking any other review of a pesticide 
pursuant to this Act.
    (2)(A) DATA. - The Administrator shall use the authority in 
subsection (c)(2)(B) to require the submission of data when such 
data are necessary for a registration review.
    (B) DATA SUBMISSION, COMPENSATION, AND EXEMPTION. - For purposes 
of this subsection, the provisions of subsections (c)(1), (c)(2)(B), 
and (c)(2)(D) shall be utilized for and be applicable to any data 
required for registration review.

IV. Notice of Proposed Rulemaking

    EPA published proposed procedures for the registration review of 
pesticides on July 13, 2005 (70 FR 40251) (FRL-7718-4). A copy of the 
proposed rule may be found in Docket EPA-HQ-OPP-2004-0404, which can be 
accessed electronically at: http://www.regulations.gov. The 90-day 

comment period for this proposed rule ended on October 11, 2005.
    The preamble to the proposed rule discussed:
     Statutory authority and legislative history.
     The Agency's goals for the registration review program.
     Evaluating approaches to registration review.
     Factors considered in designing the registration review 
program.
     Design options considered for the registration review 
program.
     Testing the proposed registration review decision process.
     Proposed procedures for registration review.
     Relationship of registration review to other FIFRA 
activities.
     Phase-in of the registration review program.
     Results of reviews required by statutes and executive 
orders.

V. Overview of Comments

    EPA received 23 comments on the proposed rule, as follows:
     One individual.
     Two consultants.
     One public interest group.
     Four registrants.
     One State Pesticide Safety Coordinator.
     Three State Lead Agencies for pesticides.
     Five California water sanitation agencies.
     Six trade associations.
    The Agency's analysis of these comments showed that the comments 
can be organized into three broad topic areas:
     Requests for changes in the procedural regulations. These 
comments and the Agency's response are discussed in this preamble.
     Operation and implementation of the registration review 
program. These comments and the Agency's response are discussed in this 
preamble.
     Issues concerning the licensing of pesticides in general 
are described in the response to comments document that the Agency has 
placed in the docket for this rulemaking.
    In general, comments on the proposed rule resulted in minimal 
revisions in the final rule. Early implementation will continue to be 
discussed with the Pesticide Program Dialogue Committee, a stakeholder 
advisory committee established under the Federal Advisory Committee 
Act. EPA may issue additional guidance on the registration review 
program as it gains experience with these procedures.

VI. Comments on the Procedural Regulations

A. Sec.  155.40--General

    This section describes the purpose of the regulations in Subpart C-
-Registration Review Procedures and states that the goal of these 
procedures is a review of each pesticide's registration every 15 years. 
This section also specifies that the regulations apply to pesticides 
registered under section 3 or section 24(c) of FIFRA, states that the 
Agency may undertake any other review under FIFRA at any time and that 
the Agency will use FIFRA section 3(c)(2)(B) to require new data or 
information that are necessary for a pesticide's registration review.
    1. Authority to establish procedures for registration review. A 
trade association questioned EPA's authority to establish the proposed 
procedures for registration review. They asserted that in the absence 
of specific procedures in FIFRA for the administration of registration 
review, EPA must use procedures in FIFRA section 3(c)(8) which 
specifies procedures for conducting interim administrative review to 
develop a risk-benefit evaluation of a pesticide. Procedures for 
implementing FIFRA section 3(c)(8) are described in 40 CFR part 154.
    The Agency does not agree with this comment. FIFRA section 
3(g)(1)(A), which mandates a periodic review of the registration of 
pesticides, requires the Agency to establish procedures for conducting 
such reviews. This provision means that, except for limitations 
specified in FIFRA section 3(g)(1)(B) and FIFRA 3(g)(2), EPA has the 
authority to develop procedures for the conduct of this new program. 
Accordingly, EPA is not required to use procedures in FIFRA section 
3(c)(8) to conduct the review mandated in FIFRA section 3(g).
    2. Registration review of pesticides covered under FIFRA section 
25(b). An industry comment asked EPA to assure that products exempted 
from FIFRA regulation under section 25(b) of FIFRA are reviewed 
adequately, especially with regards to health claims.
    Pesticides that are exempt from FIFRA requirements under FIFRA 
section 25(b) are identified in 40 CFR 152.20, Exemptions for 
pesticides regulated by another Federal agency, and 40 CFR 152.25, 
Exemptions for pesticides of a character not requiring FIFRA 
regulation. Pesticides covered by FIFRA section 25(b) are not subject 
to registration review. However, some products that are exempt under 
FIFRA section 25(b) could be affected by actions taken in registration 
review. For example, pesticide-treated articles or substances described 
in Sec.  152.25(a) could be affected if issues arise during the 
registration review of a pesticide used to treat an article or 
substance. If the pesticide product or its use on treated articles or 
substances were canceled, the treated article or substance would no 
longer meet the requirements of Sec.  152.25(a), which specifies that 
the pesticide used to treat an article or substance must be registered 
for that use.

B. Sec.  155.42--Baseline Dates for Registration Review Cases

    In Sec.  155.42(d), EPA proposed to establish a baseline date for 
each registration review case. In general, the baseline date would be 
the date of initial registration of the oldest product in the 
registration review case or the date of reregistration, whichever is 
later.

[[Page 45722]]

The date of reregistration would be the date on which either a 
Reregistration Eligibility Decision (RED) or an Interim Reregistration 
Eligibility Decision (IRED) was signed, whichever date the Agency 
determines to be most appropriate.
    An industry comment suggested that to avoid duplication of effort, 
the Agency should amend Sec.  155.42 to use the date of approval of 
significant new uses as the baseline date for the registration review 
case.
    The Agency intended the baseline date to be the date of the last 
comprehensive review. A review of a new use may not be comprehensive--
previously approved uses may not be included in the evaluation of the 
new use. Generally, when conducting a registration review of a 
pesticide for which a significant new use was recently approved, EPA 
would not redo the recent review but would incorporate the risk 
assessment for the new use into the registration review.
    Another commenter asserted that baseline dates should be either the 
initial registration of a pesticide or the completion of the RED. The 
commenter stated that the IRED should not be used because it does not 
include an assessment of cumulative risk that is required for 
pesticides that have a common mechanism of toxicity with other 
substances. For such pesticides, the Agency should use the date of the 
RED (as opposed to IRED) to establish a common baseline date for all 
the pesticides included in the cumulative risk assessment.
    The Agency agrees that the RED would update the comprehensive IRED 
regarding cumulative risk or other issues but the RED itself may not be 
a comprehensive review. For cases where there is both an IRED and a 
RED, the Agency needs the flexibility to decide which document 
represents a comprehensive review. Accordingly, this final rule allows 
the Agency to use the date of either document as the baseline date.

C. Sec.  155.44--Establishing and Announcing Schedules for Registration 
Review

    1. Chronological vs. risk-based criteria as basis for establishing 
schedules for registration review. In Sec.  155.44, EPA proposed that 
schedules would be based on the baseline date of the registration 
review case or on the date of the last registration review of the 
registration review case. The rule allows the Agency to take into 
account other factors, such as achieving process efficiencies, when 
setting schedules. The preamble of the proposal described other factors 
that the Agency might consider. In July 2006, EPA released draft 
schedules that were developed using procedures in the proposed rule. 
Under the draft schedules, EPA would review chemically related 
registration review cases together.
    While most commenters supported the proposed chronological 
approach, public interest groups and water treatment authorities 
advocated risk-based approaches for scheduling. Several industry groups 
did not like the chemical groupings in the Agency's draft schedules, 
preferring that cases be scheduled for registration review in a 
strictly chronological order. They argued that grouping cases together 
undermines the chronological order of the schedule and that the order 
of groups in the schedule would be based on risk concerns. One industry 
group asked the Agency to include in the rule criteria for deviating 
from a chronologically based schedule and to consult registrants 
regarding the selection of new dates.
    While the Agency appreciates that there is a range of views as to 
how to set schedules for the registration review program, the 
establishment of schedules is within the Agency's discretion. EPA 
believes that reviewing similar cases together facilitates decision 
making for pesticides with similar scientific or regulatory issues and 
would be an efficient use of resources. Registrants or other 
stakeholders may notify the Agency regarding particular issues that 
could impact the schedule. The Agency would consider such issues as 
appropriate.
    2. Considerations that could change the registration review 
schedule. The Agency may consider factors other than the baseline date 
of the registration review case when developing schedules for 
registration review. As discussed in Unit IX.E. of the preamble of the 
proposed rule and as shown on the draft schedule released in July 2005, 
the Agency plans to cluster identified cases belonging to the same 
chemical class or group to promote efficiency of review for the Agency 
and provide a ``level playing field'' for industry. Additionally, 
because the Agency's economic analysis of this regulation suggested 
that a small business (i.e., a business that meets criteria established 
by the Small Business Administration) might face high data generation 
costs if it holds registrations in two or more registration review 
cases that are scheduled to undergo registration review in the same 
year, the Agency may schedule these cases out of chronological order.
    The Agency has a continuing obligation to respond to emerging risk 
concerns (discussed in Unit XI.B. of the preamble of the proposed 
rule). At any time, the Agency may receive new information that 
suggests that the Agency should reevaluate a previous decision to 
register a pesticide. After the registration review program begins, the 
Agency will continue to address emerging risk concerns. If a pesticide 
presents an urgent potential risk of concern, the Agency may opt to 
review all other aspects of the pesticide's registration at that time, 
rather than only looking at the risk of concern. In such cases, the 
Agency may update the registration review schedule by announcing the 
new date of the registration review of this case.
    In general, the Agency may consider these and other factors, 
including issues raised by the public or the registrant when reviewing 
a posted schedule, to schedule a pesticide registration review, or to 
modify the schedule of a pesticide registration review as appropriate.
    3. Three-year schedules. Although the preamble of the proposed rule 
contemplated maintaining a 3-year schedule, the proposed rule did not 
specify a timeframe. In response to comments requesting this change, 
the Agency has modified Sec.  155.44 to specify that the schedules 
would cover the current year and at least two subsequent years.

D. Sec.  155.46--Deciding that a Registration Review is Complete and 
Additional Review is Not Needed

    Under Sec.  155.46, the Agency may propose that no additional 
review of a pesticide is needed in order to determine whether the 
pesticide continues to meet FIFRA requirements for registration. The 
Agency would announce the availability of such proposals and take 
comment on them. In response to comments on a proposal made under Sec.  
155.46, EPA may reconsider its proposal and schedule a registration 
review of the pesticide.
    The Agency received one comment asking the Agency to clarify the 
purpose of this provision. The purpose of this provision is to give the 
Agency flexibility to not schedule a pesticide for registration review 
if the pesticide has such low toxicity, exposure or risk that another 
review would not change the Agency's position and would not be an 
effective use of resources. The Agency may also use this provision for 
a pesticide that has recently undergone a comprehensive review. In 
proposed decisions issued under Sec.  155.46, the Agency generally 
would explain why it believes that no additional review is

[[Page 45723]]

necessary and reference, as appropriate, publicly available 
documentation to support the Agency's position.
    To clarify the procedures it will use in Sec.  155.46, EPA is 
modifying the second sentence to read, ``In such cases, instead of 
establishing a pesticide registration review case docket as described 
in Sec.  155.50, the Agency may propose that, based on its 
determination that a pesticide meets the FIFRA standard for 
registration, no further review will be necessary.'' EPA is clarifying 
the status of pesticides subject to this section by adding the 
sentence, ``The date of the final notice of availability would be used 
as the date of the latest registration review for the purpose of 
scheduling subsequent registration reviews.''

E. Sec.  155.48--Data Call-In

    Section 155.48 provides that, as required by FIFRA section 3(g), 
EPA will use procedures in FIFRA section 3(c)(2)(B) to require 
submission of data that are needed to conduct a pesticide's 
registration review. This paragraph stipulates that the data protection 
provisions of FIFRA 3(c)(1), (c)(2)(B), and (c)(2)(D) apply to the 
submission, compensation and exemption of data required to conduct a 
registration review.
    1. Data Call-In procedures. One comment asked why the proposed rule 
does not impose any requirements under FIFRA 3(c)(2)(B). The commenter 
suggested that additional data collection authorities are needed and 
procedures to ensure all necessary data must be included in this rule.
    The Agency finds that it is not necessary to develop new procedures 
for calling in data for registration review because FIFRA section 3(g) 
requires the Agency to use section 3(c)(2)(B) to collect the data, and 
that section provides EPA with sufficient authority to obtain any 
necessary data.
    2. Data compensation for ``voluntarily'' submitted data. Industry 
comments asked that the proposed rule clarify the data compensation 
status of information voluntarily submitted in response to registration 
review. Some comments suggested that the rule specify the mechanisms 
for requesting and obtaining a Data Call-In notice (DCI) before the 
data are submitted in order to protect data compensation rights. Other 
comments suggested that studies used in the registration review 
decision, particularly studies generated under revisions to the data 
requirements in 40 CFR part 158, be presented in the decision document. 
Registrants asked that in addition to determining whether a pesticide 
meets the FIFRA risk/benefit standard, EPA should assure that the 
registrant of the pesticide is entitled to use data supporting the 
risk/benefit determination for the pesticide.
    The Agency acknowledges the importance of this issue and agrees 
that this concern should be addressed in the conduct of the 
registration review program. FIFRA section 3(g)(2)(A) directs the 
Agency to utilize section 3(c)(2)(B) to require the submission of data 
when such data are necessary for a registration review. Similarly, 
FIFRA section 3(g) requires that the data compensation provisions, 
including those set forth in sections 3(c)(1), 3(c)(2)(B), and 
3(c)(2)(D) ``be utilized for and applicable to any data required for 
registration review.'' Hence, to the extent the Agency requires any 
data for registration review, such data are eligible for the data 
protections provided by the statute.
    If a company submits data or information to the docket voluntarily 
(as opposed to providing these data or information in response to a 
DCI), such data are not ``required'' data eligible for protection under 
the statute. However, the Agency may evaluate these data or information 
and find that it must rely on this information to support the continued 
registration of pesticide products. If the Agency makes such a finding 
in the course of a pesticide's registration review, this finding would 
be a determination that the voluntarily submitted data or information 
are now required. This would be a ``compensable event'' and would 
trigger the requirement for compensation to be addressed. The 
competitors to the original submitter would be required to submit their 
own data or offer data compensation to the data submitter for use of 
the study. A ``compensable event'' would also arise should the Agency 
issue a Data Call-In Notice for the same data as were previously 
submitted voluntarily, but a Data Call-In Notice is not necessary to 
trigger compensability should the Agency determine and announce as part 
of its registration review decision that the particular data were 
required to support the registrations in question.
    The Agency's registration review decision document may identify 
such data or information and the registration review decision document 
may establish a deadline for registrants whose registrations depend on 
such data to offer compensation to the owners of the data or submit 
their own data. The Agency may cancel the product registration of 
registrants who fail to adequately support a registration.

F. Sec.  155.50--Initiate a Pesticide's Registration Review

    EPA proposed to establish a docket for each registration review 
case, except for cases covered under Sec.  155.46. The docket would 
describe information that the Agency may consider in the course of a 
pesticide's registration review and describe information that the 
Agency does not have that might be useful in the review. The public 
would be invited to review information in the docket and submit, within 
60 days, any other information that they believe should be considered 
in the pesticide's review. A pesticide's registration review begins 
when EPA opens the docket for registration review case.
    1. Timeframe for submitting comments. As originally proposed, the 
timeframe for submitting comments in response to a notice issued under 
Sec.  155.50(b) would be ``60 calendar days.'' In response to comments 
that this time frame would not be long enough, the Agency is modifying 
this paragraph to specify that the time frame for such comment periods 
will be ``at least 60 calendar days.''
    2. Late submissions. Comments from industry and others asked the 
Agency to clarify its position regarding data or information submitted 
after the due date established in the notice announcing the opening of 
the pesticide registration review case docket.
    Under Sec.  155.50(c)(1), the Agency will consider late submissions 
if the Agency believes that the new data or information are critical 
for the regulatory decision, such as health effects or ecological 
effects data or exposure data that the EPA could use to refine a risk 
assessment.
    If a person has data or information that he/she believes that 
Agency should consider during the pesticide's registration review, but 
the data or information will not become available before the expiration 
of the comment period, he/she may either request an extension of the 
comment period, or in accordance with Sec.  155.52, consult with the 
Agency regarding a submission date for these materials.
    3. Information submitted under Sec.  155.50(c). Comments from 
industry asked the Agency to modify Sec.  155.50(c) to specify the 
types of information that might be submitted under this paragraph and 
to reference quality and scientific criteria for data that might be 
submitted as comments during a pesticide's registration review.
    In the preamble of the proposed rule, EPA described the kinds of 
information that, based on its experience in the pesticide 
reregistration program, might

[[Page 45724]]

be useful in registration review. As the Agency and its stakeholders 
gain experience in the registration review process, it may become clear 
what types of information are most useful. EPA could then develop 
appropriate guidance. In accordance with the Data Quality Act, EPA has 
already issued guidance regarding the quality of information that it 
relies upon for regulatory decisions. This guidance is available at 
EPA's website at: http://www.epa.gov/quality/informationguidelines/. 

The Agency will use this guidance in the registration review of 
pesticides.

G. Sec.  155.52--Stakeholder Engagement

    Under Sec.  155.52, the Agency may meet with registrants or other 
stakeholders during a pesticide's registration review or to prepare for 
a forthcoming review. This section explains the procedure for releasing 
minutes or other material relating to such meetings.
    Comments from industry asked that the rule provide an acceptable 
framework for activities in the pre-initiation stage. Other commenters 
remarked that non-registrants should have more access to the 
registration review process and that the public should be able to view 
all information, including reports from consumers about adverse 
effects. Additionally, they asserted that EPA should announce 
consultation opportunities in the Federal Register. Other comments from 
industry emphasized their concern that EPA not release confidential 
business information.
    In this document, the Agency is establishing procedures that 
provide the public with the opportunity to participate in the review 
process and to review materials that the Agency uses as the basis of 
proposed registration review decisions.
    The Agency generally does not announce in the Federal Register 
meetings with registrants or other stakeholders because it needs the 
flexibility to hold such meetings when the need arises. EPA may meet 
privately with industry to discuss proprietary or other confidential 
business information. Under Sec.  155.52(a) and (b), EPA will place in 
the docket minutes of meetings with registrants or other stakeholders. 
EPA's protection of information claimed to be confidential business 
information is governed by section 10 of FIFRA and the Agency's 
regulations in 40 CFR part 2.

H. Sec.  155.53--Conduct of a Pesticide's Registration Review

    This section describes how the Agency will assess the significance 
of changes in statutes and regulations, risk assessment procedures or 
methods, or data requirements and any new information about the 
pesticide to determine whether additional review of the pesticide is 
warranted. If a new review of the pesticide active ingredients or 
individual products in a registration review case is needed, the Agency 
will determine whether additional information is necessary to conduct 
the review. This section also provides for public review and comment 
during the review process. Under the proposed procedures, the Agency 
would generally establish comment periods of ``at least 60 calendar 
days,'' except in Sec.  155.53(c) where the comment period is ``at 
least 30 calendar days.''
    1. Agency's approach for conducting registration review. The Agency 
received several comments that disagreed with the Agency's proposed 
approach for conducting a pesticide's registration review. An industry 
trade association reiterated comments made in response to the April 
2000 Advance Notice of Proposed Rulemaking (65 FR 24585, April 26, 
2000) (FRL-6488-9) that the Agency should use a checklist or decision 
tree for deciding whether a pesticide continues to meet the 
requirements for registration. Other stakeholders expressed concern 
that the proposed approach was not sufficiently rigorous and would lead 
to relaxed standards.
    In the preamble of the proposed rule, the Agency described 
alternative approaches for conducting a pesticide's registration review 
and explained why it selected the proposed approach. The comments do 
not raise issues or concerns that would alter EPA's choice of approach. 
It is important to note, however, that although the Agency has not 
chosen to use a pure checklist approach, it is using a decision 
paradigm that ensures that the process will be transparent while still 
providing sufficient flexibility to allow for the scope and depth of a 
particular review to be tailored to the circumstances of the particular 
registration review case.
    2. Review of individual product registrations. Some registrants 
expressed their belief that the Agency should conduct a comprehensive 
review of individual product registrations to assure adequacy of 
product labels, product-specific data, and any claims for generic data 
exemption under FIFRA section 3(c)(2)(D).
    As explained in the preamble of the proposed rule, during the 
comment period on the initial registration review case docket, the 
public may comment on the need for a new review of individual product 
registrations. The Agency will continue to comply with its data 
protection obligations under FIFRA section 3(c)(2)(D).
    3. Public participation procedures. Several commenters noted that 
under the Agency's procedures for public participation in the 
reregistration and tolerance reassessment programs, the Agency may 
announce the availability of a revised risk assessment and may invite 
the public to suggest approaches for mitigating the risks identified in 
the revised risk assessment. The proposed procedures for registration 
review did not provide this opportunity.
    In response to this comment, the Agency is revising Sec.  155.53(c) 
so that it may provide the public an opportunity to comment on possible 
risk mitigation when a revised risk assessment shows risks of concern. 
However, if immediate action is warranted, the Agency may initiate 
cancellation or suspension procedures under FIFRA section 6. In this 
event, the Agency would not provide the opportunities for public 
comment described in Sec.  155.53(c) but would follow procedures in 
FIFRA section 6, as appropriate.
    4. Length of comment periods. Several commenters asserted that the 
comment periods provided in the proposed regulation were not long 
enough.
    Generally, where EPA publishes a document for comment, the Agency 
considers requests for extension if a reasonable basis for extension is 
provided. It is not necessary to modify these regulations to provide 
for extending comment periods.

I. Sec.  155.57--Registration Review Decision

    This section states that a registration review decision is the 
Agency's determination whether a pesticide meets, or does not meet, the 
standard for registration under FIFRA.
    1. Goal of registration review. The California Stormwater Quality 
Association asserted that the goal of registration review should be to 
protect water quality and minimize the need to mitigate pesticide 
impacts through Clean Water Act (CWA) mechanisms.
    The Agency believes that the goal of registration review is set 
forth in FIFRA section 3(g) and reiterated in Sec.  155.40. 
Registration review is a determination whether a pesticide continues to 
meet the FIFRA standard for registration, including, among other 
things, that the pesticide does not cause unreasonable effects on the 
environment. As part of this review, EPA will assess the effects of 
pesticides on water quality. However, while meeting CWA standards is 
important, it is not the only goal of registration review.

[[Page 45725]]

    2. FIFRA standard for registration. (a) Comments from industry 
strongly oppose EPA's intention to consider a pesticide's benefits 
during registration review. The comments referred to a discussion in 
the preamble of the proposed rule where EPA explained that it would 
evaluate information about the benefits of a pesticide with known high 
risks during registration review if a new and safer alternative to a 
pesticide has become available. The comments asserted that it is 
inappropriate for the Agency to base continued registration of a 
pesticide on a comparative benefits assessment with other pesticides. 
The comments cited FIFRA section 3(c)(5) to support their assertion 
that when pesticides meet the registration criteria of FIFRA, the 
Agency should not be allowed to make marketplace decisions of one 
product over another. FIFRA section 3(c)(5) states, ``The Administrator 
shall not make any lack of essentiality a criterion for denying 
registration of any pesticide. Where two pesticides meet the 
requirement of this paragraph, one should not be registered in 
preference to the other.''
    EPA believes the commenter misapprehends the nature of FIFRA's 
risk-benefit balancing standard. A determination that a pesticide meets 
the registration standard under FIFRA at one time does not necessarily 
mean that the same pesticide will meet the standard at all times in the 
future, even if the science associated with the risks posed by the 
pesticide does not change. Significant changes in the benefits picture, 
such as the development of pest resistance or new alternatives, can 
also affect whether a pesticide continues to meet the FIFRA 
registration standard. EPA does not intend to compare benefits of two 
or more pesticides that do not pose risks of concern. As the commenters 
noted, EPA may not make a determination of essentiality when two 
pesticides meet the FIFRA requirements for registration. However, when 
there are risks of concern for a pesticide, FIFRA requires EPA to weigh 
those risks against the benefits of that pesticide to determine whether 
the risks are unreasonable. Benefits are the advantages that accrue to 
the pesticide users or society in general, such as increased 
production, decreased production costs, pest-free homes, or disease-
vector control. The magnitude of those benefits often depends on the 
availability of alternative pest control measures, whether chemical, 
biological or cultural. Benefits are, in general, expected to be higher 
when there are no viable alternatives.
    During registration review, EPA may reassess a pesticide that has 
remained registered even though high risks are associated with the use 
of the pesticide. In its earlier review, the Agency may have found that 
the pesticide did not pose unreasonable risk because of the high 
benefits of the pesticide. In registration review, EPA may find that 
existing risk assessments that identify these risks of concern are 
still valid. EPA would then determine whether the pesticide continues 
to provide sufficient benefits to justify maintaining the registration. 
The benefits finding could depend on whether new, safer alternatives 
have been registered since EPA's earlier decision. EPA conducted 
similar analyses in the reregistration program.
    If EPA's review of a pesticide's registration appears to show that 
the pesticide does not meet the FIFRA standard for registration, EPA 
would follow procedures in FIFRA section 6 to change, cancel or suspend 
the pesticide's registration. This section sets out where it requires 
EPA to assess the benefits of the pesticide and provides opportunities 
for public hearings on whether the pesticide's registration should be 
changed, canceled, or suspended. The Agency would not analyze benefits 
when a registrant responds to the Agency's registration review finding 
by agreeing to the cancellation of a pesticide or termination of one or 
more of its uses under FIFRA section 6(f). However, FIFRA provides the 
public an opportunity to comment on the proposed action.
    (b) Another registrant asserted that the registration review 
regulations should contain language that specifically reaffirms the 
standard of imminent hazard and substantial risk as the basis for 
cancelling pesticide registrations. He cited a specific product example 
to illustrate his belief that the Agency employed a ``zero tolerance 
agenda'' during reregistration.
    The standard of ``imminent hazard'' referred to by the commenter 
applies to suspensions and emergency suspensions under FIFRA section 
6(c). This section sets forth the standard for a suspension or an 
emergency suspension. This is not the standard that the Agency will use 
in making registration review decisions. The Agency interprets 
registration review to be a determination that a pesticide continues to 
meet the standard for registration in FIFRA section 3(c)(5), or, where 
appropriate, section 3(c)(7). This standard specifies, among other 
things, that a pesticide may not pose unreasonable risk to man or the 
environment.
    When a pesticide poses risks of concern to humans or the 
environment, the Agency must address these risks. The options for 
addressing such risks include risk mitigation, determining that the 
risks are justified in light of the benefits of the pesticide, or 
initiating regulatory options to modify or cancel the registration. EPA 
generally consults with registrants and other stakeholders when 
deciding how to mitigate a risk. In addition, EPA has modified the 
proposed public participation procedures for registration review to 
generally add a public comment period when a pesticide poses risks of 
concerns so members of the public can provide suggestions for reducing 
the risk. This procedure provides registrants and other stakeholders an 
opportunity to provide input on the Agency's risk management decisions.

J. Sec.  155.58--Procedures for Issuing a Decision on a Registration 
Review Case

    In this section, EPA explains that it will issue proposed 
registration review decision documents for public review and comment. 
In comments on the proposed rule, various stakeholders advised the 
Agency of their expectations and needs regarding the documentation of 
registration review decisions and suggested how this documentation 
might be presented. EPA appreciates these suggestions. The Agency has 
consulted the Pesticide Program Dialogue Committee and has considered 
their recommendations together with comments submitted on the proposed 
procedural regulations. Nothing in the comments indicates the need to 
modify the regulation to specify the format of the registration 
decision document.

VII. Comments on the Operation of the Registration Review Program

A. Scope of the Registration Review Program

    1. Is registration review a safety net? In the preamble of the 
proposed rule, the Agency described how it intended to use registration 
review as the framework for managing the regulatory status of existing 
pesticides.
    Industry trade associations did not agree with this approach. In 
their comments, they asserted that EPA should not expand registration 
review beyond the intent of Congress because to do so risks repeating 
the Agency's experience with reregistration which began as a 5-year 
program in 1972 and still has not been completed. They asserted that 
registration review should not be a catch-all for other programs and 
actions. For example, special review, actions under FIFRA section 
3(c)(8),

[[Page 45726]]

FIFRA section 6 or the Pesticide Registration Improvement Act (PRIA) 
should not be included in the registration review program. They believe 
that new programs such as endocrine disruptor screening and testing 
should be conducted independently of registration review. The industry 
comments advocate that, as far as possible, registration review should 
be a safety net.
    EPA does agree that registration review is not the only mechanism 
for addressing pesticide registration issues, and will continue to use 
other provisions of FIFRA to address particular registration issues. 
However, EPA does not agree with the comment that registration review 
should function solely as a safety net to discover and resolve issues 
missed or overlooked in registration, tolerance reassessment, or 
reregistration activities. While EPA expects that it will occasionally 
discover issues that were overlooked in previous reviews, the purpose 
of registration review is to consider the pesticide in light of new 
knowledge that was not available for previous reviews.
    EPA interprets the Congressional mandate for registration review to 
be a periodic assessment whether a pesticide continues to meet the 
FIFRA standard for registration in light of new knowledge. Therefore, 
the scope of a pesticide's registration review includes all aspects of 
a pesticide's registration specified in section 3(c)(5) of FIFRA with 
respect to product composition, labeling and other required material, 
and risks and benefits. Registration of new pesticides or new uses of 
pesticides under PRIA is a separate program from registration review. 
However, in evaluating a new use under PRIA, the Agency would consider 
all relevant information, including information that it might consider 
during the pesticide's registration review.
    2. Incorporating evolving or new programs into registration review. 
As explained in the preamble of the proposed rule, EPA intends to 
incorporate new requirements, such as endocrine disruptor screening and 
testing or endangered species assessments into the registration review 
program as these aspects of risk assessment mature into routine 
evaluations for pesticides.
    Industry commenters advised the Agency to avoid using registration 
review as the sole process for handling new issues. They asserted that 
attaching all these assessments (endangered species assessments, 
endocrine disruptor screening and testing, review of substitutes, etc.) 
to a program intended to accomplish periodic review of all pesticides 
will undermine the timeliness of the review process for a great many 
pesticides. Commenters believe that this may result in an ever-changing 
schedule that will deprive registrants and users of predictability and 
lead to significant inefficiencies within the Agency.
    Again, EPA does not intend to use registration review as the only 
mechanism for addressing pesticide registration issues. However, EPA 
believes it is appropriate to use registration review as the framework 
for managing its responsibilities regarding existing pesticides. In 
making a FIFRA section 3(c)(5) decision as required under FIFRA section 
3(g), EPA must consider all information that pertains to that decision. 
EPA regards endangered species assessments required under the 
Endangered Species Act or endocrine disruptor screening and testing 
required under the Federal Food, Drug, and Cosmetic Act as part of the 
risk characterization of the pesticide that is intrinsic to the FIFRA 
risk/benefit decision. If knowledge exists on these or other scientific 
issues at the time of a pesticide's registration review, the Agency 
believes it must consider them when it makes its FIFRA (3)(c)(5) 
finding.
    3. Managing emerging issues. In the preamble of the proposed rule, 
the Agency explained that it will continue to give priority to emerging 
risk concerns. While reviewing the new risk concern, the Agency may 
find that it would be more efficient to review all other aspects of the 
pesticide's registration at the same time. The procedural regulations 
for registration review provide flexibility to amend the schedule to 
advance the registration review of a pesticide in this circumstance. 
The Agency would provide as much advance notice as possible regarding 
such changes in the schedule.
    Commenters took exception to EPA's approach for managing emerging 
issues arguing that newly discovered risks of potential concern should 
be dealt with outside of registration review if the risks are urgent. 
The commenters believe that registration reviews should not be 
rescheduled under this circumstance.
    The Agency does not agree that it should reassess the approach 
described in the preamble of the proposed rule. EPA fully explained its 
reasoning in the proposed rule and the comments do not persuade it 
otherwise. This is not to say that the Agency will not address urgent 
risks of concern outside the registration review process if the Agency 
determines that to be the appropriate course of action.
    4. Assessing risks of substitute pesticides. In the preamble of the 
proposed rule, EPA explained that it might advance the registration 
review of pesticides that are potential substitutes for a pesticide or 
some uses of the pesticide that are being canceled under FIFRA section 
6 because of risk concerns.
    Industry commenters expressed concern that EPA would even consider 
using the registration review program to address reviews that might be 
the outgrowth of cancellation proceedings.
    EPA generally would assess risks of substitute pesticides as part 
of the cancellation process in FIFRA section 6. In the rare event that 
it is necessary to perform a comprehensive review of a substitute 
pesticide, such a review might be tantamount to conducting the 
registration review of that pesticide. In such cases, EPA might find 
that it would be more efficient to conduct the registration review of 
the pesticide at the same time.
    5. Review of inert ingredients. In the preamble of the proposed 
rule, EPA explained that it would handle inert ingredients in a process 
that is separate from registration review.
    Some commenters agree with EPA's approach of dealing with inert 
ingredients. However, others question the need to review inert 
ingredients at all. A public interest group expressed concern that 
having separate review processes for active ingredients and inert 
ingredients could result in missing or ignoring synergistic effects of 
mixtures of ingredients.
    The Agency intends to follow the procedures outlined in the 
preamble of the proposed rule. The Agency recognizes that there may be 
interactions among the various chemicals in pesticide products. 
Currently, the Agency requires acute toxicity data for end-use 
products, i.e., formulations containing active and inert ingredients. 
These studies address, albeit to a limited extent, potential 
synergistic effects of mixtures of active and inert ingredients in a 
pesticide product. However, to test and review all of the potential 
combinations of ingredients would require significant resources. The 
Agency will consider new scientific methodologies to identify potential 
interactions among chemicals, should they become available.

B. Data and Information Collection in the Registration Review Program

    In the preamble of the proposed rule, the Agency described 
strategies for acquiring information to support a pesticide's 
registration review including issuing Data Call-In notices to require

[[Page 45727]]

data necessary to conduct a review and searching the published 
literature for pertinent information about a pesticide. The Agency 
explained that early acquisition of data or information that could be 
useful in refining a pesticide's risk assessment would reduce the time 
and effort needed to complete the review of a pesticide. As explained 
in the preamble, EPA might be able to identify data or information 
needs when it publishes the schedule for a pesticide's registration 
review. In some cases, data or information needs might become apparent 
when the Agency assembles the initial docket for the registration 
review case. In this event, the docket for the registration review case 
would identify data or information needs. In other cases, the Agency 
might not be able to identify data or information needs until it 
evaluates the information in the initial docket.
    1. Identification of information that may be used to refine risk 
assessments. An industry trade group acknowledged EPA's concern about 
redoing risk assessments when, in response to a preliminary risk 
assessment, a registrant or other stakeholder submits new data or 
information to refine the preliminary risk assessment. However, they 
believe that such iteration is inevitable. When registrants conduct 
their own risk assessments, they may use different assumptions or 
interpretations of data than the Agency uses in its risk assessments. 
When the Agency's risk assessment shows higher risks than the 
registrants found in their own assessments, they must either develop 
data or information to refine the risk assessment or cancel uses.
    EPA agrees that some iteration may be inevitable. However, the 
Agency publishes its risk assessment methods, including its approach 
for interpreting data. So it may be possible for registrants to 
anticipate the Agency's information or data needs in a forthcoming 
registration review and to reduce the degree of iteration in the risk 
assessment process.
    2. Information developed under the Clean Water Act. In public 
discussions about the proposed rule, EPA received a suggestion from 
water treatment authorities that the Agency might consider information 
developed under section 303(d) of the Clean Water Act, which identifies 
impaired water bodies.
    In comments, States raised the concern that they do not have the 
resources to assemble such data. Registrants expressed their concern 
that these data not be taken at face value because the criteria and 
process used to develop these data might affect the reliability of this 
information.
    EPA believes that information on water quality may be useful in 
registration review and will make efforts to obtain State data for CWA 
section 303(d) listings due to pesticides. When evaluating such data, 
EPA will take into account the procedures used to develop the data to 
assess the quality and usefulness of the data.

C. Work-Sharing

    The preamble of the proposed rule described the Agency's intention 
to develop work-sharing agreements with its partners in the 
Organization for Economic Cooperation and Development (OECD) or the 
North American Free Trade Agreement (NAFTA). In comments on the 
proposed rule, industry trade associations expressed concern that 
conducting reviews jointly with EPA's NAFTA or OECD partners might 
cause delays.
    EPA continues to believe that harmonization and work-sharing will 
result in process efficiencies and superior decisions. Since EPA's 
partners also have programs for reassessing pesticides, all parties 
could benefit by coordinating their efforts. EPA and its Canadian 
counterpart have begun discussions for work-sharing during registration 
review with the expectation that they will develop a work-sharing plan 
by the December 2006 meeting of the NAFTA Technical Working Group on 
Pesticides.
    EPA gave a presentation on the registration review program at the 
February 2006 meeting of the OECD Working Group on Pesticides. EPA 
intends to continue encouraging the OECD community to participate in 
work-sharing efforts.
    EPA may adjust its schedule slightly to take advantage of these 
potential opportunities for work-sharing.

D. Adequacy of EPA's Methods for Assessing Potential Risk to Water 
Quality

    California water-treatment authorities questioned the adequacy of 
EPA's assessment of risks with regard to water quality considerations 
including: Use of aquatic toxicity testing, surface water quality 
studies, and urban uses of pesticides, particularly when these uses 
result in pesticide residues in receiving waters for storm sewers or 
sewage treatment plants. The commenters reported that in some cases, 
pesticide residues in water released by a sewage treatment plant may 
exceed its NPDES permit, which would be a violation of the Clean Water 
Act. They also noted that residues from agricultural uses of 
pesticides, e.g., rice pesticides and pesticide degradates have been 
found in drinking water supplies.
    The Office of Pesticide Programs (OPP) will manage water-related 
issues within the framework of the registration review of pesticides. 
OPP expects that its capacity for characterizing risk will continue to 
improve as it works with the Office of Water to refine its models for 
estimating exposures and as more monitoring data become available.

E. Achieving Label Improvement through the Registration Review Program

    Several commenters see the registration review program as an 
opportunity to improve the quality of labels on individual pesticide 
products. One aspect of label improvement would be to minimize the 
number of different labels for the same product. According to comments, 
this situation arises because many States require State registration 
and impose their own labeling requirements.
    The Agency is committed to improving the consistency of labels. EPA 
already works with States on labeling issues. However, the Agency notes 
that section 24(b) of FIFRA prohibits States from establishing or 
maintaining labeling requirements. The Agency agrees that label 
improvement is a worthwhile goal for the registration review program.

VIII. Implementation Issues

A. Coordination of the Registration Review Rule with the Data 
Requirements Rule

    Industry comments asserted that EPA should delay implementing 
registration review until the recently proposed revisions to the data 
requirements in 40 CFR part 158 have been finalized. They stated their 
belief that EPA cannot make registration review decisions until it has 
completed revising the data requirements for the registration of 
pesticides. Industry is concerned that if registration review is 
initiated before a final rule on data requirements, different standards 
will apply to cases reviewed early in the program, negating one of the 
benefits of the review: to reduce market barriers.
    The Agency does not believe it is appropriate to delay 
implementation of the registration review program as suggested in the 
comments. In the absence of updated part 158 rules, the Agency makes 
case-by-case data determinations as a standard program practice. 
Registrants are familiar with this practice. While the Part 158 Data 
Requirements Rules and registration review decisions are related, they 
are

[[Page 45728]]

not inextricably linked. The revisions to part 158 have benefits but 
they are not a condition precedent to making registration review 
decisions.
    The part 158 updates may include provisions to codify current 
practices. The purpose of the part 158 rule is to capture with clarity 
and transparency changes in data requirements or application of data 
requirements that the Agency has made on a case-by-case document since 
it published its data requirements in 1984. This good-government goal 
will amplify understanding and further enhance consistency. However, 
the registration review program can operate effectively, as the 
registration, reregistration, and tolerance reassessment programs have, 
in the absence of these enhancements. Final promulgation of the part 
158 rules will simply improve on that sound foundation.
    Science will continue to evolve even after the Agency has completed 
the current revision of the data requirements in 40 CFR part 158. The 
Agency expects that it will change its data requirements to reflect 
this new knowledge. Because one of the goals of registration review is 
to incorporate evolving science, the Agency fully expects that it might 
apply new and different risk assessment tools to pesticides reviewed 
later in the 15-year cycle than it used when it reviewed pesticides 
early in the 15-year cycle.
    The Agency appreciates the commenter's concern about market 
barriers that might arise if the Agency uses different risk assessment 
tools when reviewing pesticides later in the 15-cycle than it used 
earlier in the cycle. Market barriers can be reduced if similar 
pesticides are reviewed at the same time. This is one of the benefits 
of the Agency's plan to group chemically related cases for review.

B. Transition from Reregistration to Registration Review

    Industry comments asserted that EPA must clarify when the 
registration review program will begin. EPA should address how it will 
handle the work of registration actions, reregistration actions, and 
other mandated regulatory actions before it commits to initiating the 
registration review program. EPA should clarify the transition process 
between the reregistration and registration review programs.
    The Agency has announced that the registration review program 
officially begins when these regulations go into effect. The Agency's 
first actions under the new program will be to issue schedules and to 
begin to open registration review case dockets. As noted in the 
comment, some pesticides will still be undergoing reregistration when 
the registration review program begins. The Agency recognizes that, to 
avoid confusion during the transition between the reregistration and 
registration review programs, it must clearly communicate whether 
action on an existing pesticide is taken under reregistration (FIFRA 
section 4) or registration review under FIFRA section 3(g).

C. Unresolved Problems from Reregistration Will Affect the Agency's 
Capacity to Conduct Registration Review

    Industry commented that EPA should not implement registration 
review of end-use products until it fixes the problems with the review 
of end-use products in reregistration. The review processes in 
registration review and reregistration are likely to be similar and 
registration review might duplicate the effort of reregistration, 
especially when a product may undergo product-specific review several 
times (e.g., a product that contains two or more active ingredients may 
belong in two or more registration review cases). The commenters are 
concerned that if EPA does not achieve efficiencies in the review of 
end-use products, the 15-year review will extend to 40 years.
    EPA expects reregistration to satisfy most product-specific data 
requirements and achieve many label improvements for end-use products. 
Although the Agency does not expect it will routinely require product-
specific data during registration review, it expects that registration 
review will be an important vehicle for the continuing update of 
labels. The Agency agrees that the review of end-use product labels 
could benefit from process improvements. The Agency believes that 
registrants and other stakeholders can help develop approaches to make 
this process more efficient.

IX. Program Costs

A. Impacts on Small Businesses

    Registrants commented that EPA has not accurately characterized the 
effects of registration review on small business. They suggested that 
per-company costs of $750,000 and 2% gross sales are not insignificant 
even for large entities and will have a direct adverse effect on small 
businesses. They believe that the cost projections are misleading 
because they do not include all costs incurred by a registrant such as 
existing reporting, recordkeeping, and financial burdens imposed by the 
Agency's many other on-going programs. Commenters suggested that EPA 
should re-evaluate the impacts on small business and reduce economic 
burden on them.
    EPA believes it has accurately characterized the impacts of the 
registration review procedures on the regulated community, including 
small businesses. The procedures in this rule establish what EPA will 
do to review a pesticide registration. They do not obligate a 
registrant to take any action.
    As part of the rulemaking process, EPA is required to estimate the 
economic impacts, including effects on small business, that occur as a 
consequence of the rule. Because costs resulting from existing 
reporting or recordkeeping requirements or costs from other Agency 
programs are not imposed by this rule, these costs are not included in 
the Agency's assessment of the impacts of this rule.
    The regulations do not impose new data requirements. They establish 
the process by which EPA will decide if additional data are necessary 
to determine whether a pesticide continues to meet FIFRA standards. 
That is, data generation costs are only indirectly a result of 
registration review procedures. It is important to realize that the 
per-company costs of $750,000 are primarily the cost of data 
generation; that is, they are not a direct cost imposed by this rule.
    The Agency has determined that this rule will not have a 
significant adverse impact on a substantial number of small businesses. 
Nonetheless, the Agency recognizes that, from the perspective of a 
small business whose product is undergoing registration review, the 
costs of data generation in registration review could be significant. 
Accordingly, the Agency is willing to work on a case-by-case basis with 
a small business for whom the requirements for data generation in 
registration review are burdensome. Data Call-In notices issued under 
FIFRA section 3(c)(2)(B) allow a registrant to request a data waiver 
that is based on economic factors. In lieu of a new study, the Agency 
is generally willing to consider whether substitute data or bridging 
data would be adequate. If a new study is required, the Agency may 
consider time extensions so that a registrant can spread the costs of 
data generation over a longer period of time. The Agency has made these 
options available to small businesses in the registration and 
reregistration programs and expects to continue to make them available 
for registration review.

B. Cost of Product-Specific Data

    Industry comments asserted that the economic assessment was 
incomplete

[[Page 45729]]

because it did not include the costs of generating product-specific 
data, in particular, the costs of repeating efficacy tests for public 
health pesticides. At public meetings on the proposed rule, the Agency 
said that it would require new product efficacy tests.
    These comments accurately describe the scope of the feasibility 
study. The purpose of the feasibility study was to test the validity of 
the registration review decision paradigm and to develop data for 
estimating the costs of the program. The Agency did not review 
individual product registrations in the feasibility study to determine 
whether new product-specific data, including efficacy data, would be 
required because the Agency believes that, to a great degree, these 
product-specific data requirements have been satisfied through the 
registration and reregistration programs and such data would generally 
not be needed to support a pesticide's registration review.
    During the registration review of a public health pesticide, the 
Agency would determine whether to continue to base the product's 
registration on existing product efficacy data. The Agency may ask for 
new product efficacy data if the product's composition has changed so 
that existing data no longer support the current composition of the 
product, or the test method is no longer valid, or there is information 
suggesting that the formulation might not be efficacious as claimed. 
The Agency did not review product chemistry data in the feasibility 
study to make case-by-case determinations whether existing product 
efficacy tests are appropriate for the composition of the product. The 
Agency has not revised antimicrobial efficacy test methods, so, for 
purposes of the feasibility study, the existing efficacy tests were 
considered to be valid. (If the Agency had information suggesting that 
a product in the feasibility study was not efficacious as claimed, the 
Agency would not wait until registration review to ask for new efficacy 
data. The Agency would have issued a DCI or initiated other action 
under FIFRA, as appropriate.) The Agency believes that the costs of 
replacing product efficacy data for a few products in a registration 
review case will be much lower than the costs of generating new generic 
data to support the active ingredient(s) in a registration review case. 
In any case, any costs for generating new product-specific efficacy 
data would not be a direct cost imposed by this procedural regulation.

X. Technical Changes to the Rule

    In addition to the changes made in response to comments, the final 
rule reflects that the Agency made the following technical changes to 
what was proposed:
    1. In Sec.  155.42(d), the Agency added clarifying phrases 
(indicated in italics) to the second and third sentences, as follows: 
``In general, the baseline date will be the date of initial 
registration of the oldest product in the case or the date of 
reregistration, whichever is later. The date of reregistration is the 
date on which the Registration Eligibility Decision or Interim 
Reregistration Eligibility Decision was signed, whichever date the 
Agency determines to be more appropriate based on the comprehensiveness 
of the review.''
    2. In Sec.  155.44, EPA is deleting the sentence, ``As indicated in 
Sec.  155.40, the Agency may change the schedule of a pesticide's 
registration review if circumstances warrant,'' because it is not a 
correct reference.
    3. In Sec.  155.48, EPA is deleting the phrase ``before, during or 
after a registration review'' because it is redundant.
    4. The Agency is modifying Sec.  155.50 as follows:
     In the first sentence add the phrase ``except for cases 
covered under Sec.  155.46.'' The sentence now reads, ``The Agency will 
initiate a pesticide's registration review by establishing a docket for 
each registration review case, except for cases covered under Sec.  
155.46, and opening it for public review.''
     Change the paragraph heading of Sec.  155.50(a) to 
``Contents of the registration review case docket.'' The Agency has 
deleted the first sentence of this paragraph and modified the last 
sentence to read, ``The Agency will consider including, but not limited 
to, the following information: . . .'' The Agency is making these 
changes to make clear that this paragraph describes the contents of the 
initial docket.
     Change Sec.  155.50(c) by adding ``during the comment 
period'' to the paragraph heading and by changing the first sentence in 
paragraph (c)(1) to read as follows: ``In order to ensure that the 
Agency will consider data or information in the conduct of a 
registration review, interested persons must submit the data or 
information during the comment period established in the notice 
described in paragraph (b) of this section.'' These changes are for 
clarity.
     Add paragraph Sec.  155.50(d) as follows, ``For the 
purposes of this subpart, the provisions of subpart B do not apply.'' 
EPA is making this change to eliminate any possible confusion as to 
whether docketing procedures in part 155 subpart B apply to 
registration review activities. Subpart B describes docketing and 
public participation procedures for the registration standard program 
that the Agency conducted before it began the reregistration process 
mandated in the 1988 amendments to FIFRA. The Agency will eventually 
issue a housekeeping rule to delete this subpart.
    5. In Sec.  155.52, the Agency is making editorial changes for 
clarity, as follows:
     Substitute ``other persons'' for ``public interest 
groups'' in the third sentence so that it reads, ``The Agency may 
consult with registrants, pesticide users, or other persons during a 
pesticide's registration review . . .''
     Add the phrase ``Minutes of'' to the paragraph heading of 
Sec.  155.52(a) so that it reads, ``Minutes of meetings with persons 
outside of government.''
    6. In Sec.  155.53, the Agency is making several editorial changes 
for clarity, as follows:
     Add the preposition ``of'' to the section heading of Sec.  
155.53 so that it reads, ``Conduct of a pesticide's registration 
review.''
     In the first sentence of this section, replace the 
reference to ``Sec.  155.51,'' which doesn't exist, with ``Sec.  
155.50(a), (b), and (c).''
     In the first sentence of Sec.  155.53(c)(1), replace the 
phrase ``ask for'' with the verb ``request.''
    7. In Sec.  155.58, the Agency is making an editorial change in 
paragraph (b)(3) by deleting the phrase ``precede, accompany or 
follow'' from the second sentence and replacing it with the phrase 
``may be issued in conjunction with.''

XI. FIFRA Review Requirements

    In accordance with FIFRA section 25(a) and 25(d), this rule was 
submitted to the FIFRA Science Advisory Panel (SAP), the Secretary of 
Agriculture (USDA), and appropriate Congressional Committees.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

    Pursuant to Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993), the Office of Management and 
Budget (OMB) has designated this rule as a ``significant regulatory 
action'' under section 3(f) of the Executive Order because it may raise 
novel legal or policy issues arising out of legal mandates, the 
President's priorities, or the principles set forth in the Executive

[[Page 45730]]

Order. This action was therefore submitted to OMB for review under this 
Executive Order, and any changes to this document made at the 
suggestion of OMB have been documented in the public docket for this 
rulemaking.
    EPA has prepared an economic analysis of the potential impacts of 
the registration review procedures. In addition to analyzing the 
requirements contained in this rule, the Agency analyzed other 
potential actions that could occur during a registration review using 
other existing authorities that are not changed in this rule. The 
Agency's analysis, therefore, considers the potential impact of the 
registration review process, which includes the costs of a registrant's 
participation in the public review components of the process described 
in this rule and other potential requirements imposed by existing 
authorities such as data generation under FIFRA section 3(c)(2)(B). 
This analysis is contained in a document entitled Economic Analysis of 
the Procedural Regulations for the Registration Review of Pesticides. 
EPA placed a copy of this Economic Analysis in the public docket for 
this action when it published the proposed rule. Comments on the 
Economic Analysis did not warrant revision of this document and the 
Agency will rely on this document to support the final rule. The 
Economic Analysis is briefly summarized here.
    The rule does not require registrants to take specific action as 
part of the review of a pesticide registration, however, the Agency's 
analysis assumes that registrants will engage in their own evaluation 
of information provided by the Agency and other stakeholders, and 
participate in the public process described in this rule. The Agency 
estimates such industry costs to be around $1.2 million annually.
    The Agency recognizes that under other existing authorities a 
registrant may also need to submit data that they have or generate data 
as necessary to support the registration. As such, the analysis also 
considers the potential cost to industry from other anticipated 
activities under existing authorities that may occur during the 
registration review process, although such activities are not 
requirements in this rulemaking. These activities include potential 
data submission or generation activities related to DCIs, including the 
paperwork burden, and other activities that might occur under other 
existing authorities.
    Considering these other potential activities, the analysis shows an 
estimated total annual cost to industry of about $50 million, with the 
estimates for potential data generation activities accounting for 
approximately 70% of these costs. The Agency estimates about 68 
companies will be impacted each year; thus, per-company costs for the 
entire registration review process are likely to average less than 
$750,000 each year, even though some companies may have multiple 
chemicals under review during the year. Out of the universe of 2,000 
small businesses estimated to hold pesticide registrations, the Agency 
estimates that each year about 30 small businesses that have 
responsibility for providing data to support the registration of a 
pesticide would be involved in a registration review. Assuming the same 
level of participation and potential need to generate data, the 
estimated average cost of the registration review process is estimated 
to be less than 2% of the gross sales for small businesses involved in 
a registration review.

B. Paperwork Reduction Act (PRA)

    The information collection activities associated with the 
registration review program are already approved by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act, 44 
U.S.C. 3501 et seq. That Information Collection Request (ICR) document 
has been assigned EPA ICR number 0922.07, and OMB control number 2070-
0057. Although this action does not impose any new information 
collection requirements that would require additional approval by OMB, 
the Agency expects the approved burden estimate to increase with the 
full implementation of the registration review process. A copy of the 
OMB approved ICR has been placed in the public docket for this rule, 
and the Agency's estimated burden increase is presented in the economic 
analysis that has been prepared for this rule.
    As detailed in the Economic Analysis prepared for this rule, the 
annual respondent burden for information collection activities 
associated with the registration review program is estimated to average 
120,000 hours, with an estimated total annual respondent cost of 
$10,800,000. The July 13, 2005, proposed rule invited comments on the 
Agency's need for this information, the accuracy of the provided burden 
estimates, and any suggested methods for minimizing respondent burden, 
including the use of automated collection techniques. No comments were 
received. Therefore, the Agency has submitted an information correction 
worksheet request to OMB to amend its existing ICR covering the 
information collection activities associated with the registration 
review program so that it reflects the burden estimates in the Economic 
Analysis.
    Under the PRA, ``burden'' means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
or disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; develop, acquire, 
install, and utilize technology and systems for the purposes of 
collecting, validating, and verifying information, processing and 
maintaining information, and disclosing and providing information; 
adjust the existing ways to comply with any previously applicable 
instructions and requirements; train personnel to be able to respond to 
a collection of information; search data sources; complete and review 
the collection of information; and transmit or otherwise disclose the 
information.
    Under the PRA, an agency may not conduct or sponsor, and a person 
is not required to respond to a collection of information unless it 
displays a currently valid OMB control number. The OMB control numbers 
for EPA's regulations codified in Chapter 40 of the CFR, after 
appearing in the preamble of the final rule, are listed in 40 CFR part 
9, are displayed either by publication in the Federal Register or by 
other appropriate means, such as on the related collection instrument 
or form, if applicable. The display of OMB control numbers in certain 
EPA regulations is consolidated in 40 CFR part 9. For the ICR activity 
contained in this final rule, in addition to displaying the applicable 
OMB control number in this unit, the Agency is amending the table in 40 
CFR 9.1 to list the OMB control number assigned to this ICR activity. 
Due to the technical nature of the table, EPA finds that further notice 
and comment about amending the table is unnecessary. As a result, EPA 
finds that there is ``good cause'' under section 553(b)(B) of the 
Administrative Procedures Act (APA), 5 U.S.C. 553(b)(B), to amend this 
table without further notice and comment.

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 
5 U.S.C. 601 et seq., the Agency hereby certifies that this rule will 
not have a significant adverse economic impact on a substantial number 
of small entities. This rule defines the procedures that EPA will 
follow to implement the statutory registration review provision. It 
does not impose any new requirements on the regulated community. As 
such, this rule does not have direct adverse impacts on small 
businesses, small non-profit

[[Page 45731]]

organizations, or small local governments.
    For purposes of assessing the impacts of this rule on small 
entities, small entity is defined as: (1) A small business as defined 
by the Small Business Administration's (SBA) regulations at 13 CFR 
121.201, which for the pesticide industry consists of businesses with 
fewer than 500 to 1,000 employees (range is based on NAICS sector 
variations); (2) a small governmental jurisdiction that is a government 
of a city, county, town, school district or special district with a 
population of less than 50,000; and (3) a small organization that is 
any not-for-profit enterprise which is independently owned and operated 
and is not dominant in its field. The regulated community does not 
include any small not-for-profit organizations. Small local government 
organizations, such as counties, may register a pesticide under FIFRA 
section 24(c). However, such registrants generally do not manufacture, 
distribute or sell pesticides and generally would not be responsible 
for generating data to support the registration of pesticides. 
Accordingly, the Agency finds that this rule does not have a direct 
adverse effect on small local governments.

D. Unfunded Mandates Reform Act

    Under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) 
(Public Law 104-4), EPA has determined that this action does not 
contain a Federal mandate that may result in expenditures of $100 
million or more for State, local, and tribal governments, in the 
aggregate, or the private sector in any one year. As described in Unit 
XIII.A., this rule is not expected to result in such expenditures. In 
addition, this action will not impact small governments, or local or 
tribal governments. Accordingly, this rule is not subject to the 
requirements of sections 202, 203, 204, and 205 of UMRA.

E. Executive Order 13132

    Pursuant to Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999), EPA has determined that this rule does not 
have ``federalism implications,'' because it will not have substantial 
direct effects on the states, on the relationship between the national 
government and the states, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in the Order. Thus, Executive Order 13132 does not apply to this rule.

F. Executive Order 13175

    As required by Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000), EPA has determined that this rule does not have tribal 
implications because it will not have any affect on tribal governments, 
on the relationship between the Federal government and the Indian 
tribes, or on the distribution of power and responsibilities between 
the Federal government and Indian tribes, as specified in the Order. 
Thus, Executive Order 13175 does not apply to this rule.

G. Executive Order 13211

    This rule is not subject to Executive Order 13211, entitled Actions 
Concerning Regulations that Significantly Affect Energy Supply, 
Disribution, or Use (66 FR 28355, May 22, 2001) because it is not 
designated as an ``economically significant'' regulatory action as 
defined by Executive Order 12866 (see Unit XIII.A.), nor is it likely 
to have any significant adverse effect on the supply, distribution, or 
use of energy.

H. Executive Order 13045

    Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997) does not apply to this rule because this action is not designated 
as an ``economically significant'' regulatory action as defined by 
Executive Order 12866, (see Unit XIII.A.), nor does it establish an 
environmental standard, or otherwise have a disproportionate effect on 
children.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 ((NTTAA), 15 U.S.C. 272 note) directs EPA to use voluntary 
consensus standards in its regulatory activities unless to do so would 
be inconsistent with applicable law or impractical. Voluntary consensus 
standards are technical standards (e.g., materials specifications, test 
methods, sampling procedures) that are developed or adopted by 
voluntary consensus standards bodies. This rule does not impose any 
technical standards that would require EPA to consider any voluntary 
consensus standards.

J. Executive Order 12898

    This rule does not have an adverse impact on the environmental and 
health conditions in low-income and minority communities. Therefore, 
under Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994), the Agency does not need 
to consider environmental justice-related issues.

XIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and the Comptroller General of the United 
States. EPA will submit 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 United States prior 
to publication of the rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

List of Subjects in 40 CFR Part 155

    Environmental protection, Administrative practice and procedure, 
Pesticides and pests.


    Dated: August 1, 2006.
Stephen L. Johnson,
Administrator.


0
Therefore, 40 CFR chapter I is amended as follows:
0
1. Part 9 is amended as follows:

PART 9--[AMENDED]

0
a. The authority citation for part 9 continues to read as follows:

    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 
2005, 2006, 2601-2671, 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 
9601-9657, 11023, 11048.


0
b. In Sec.  9.1, the table is amended by revising the existing heading 
for ``Registration Standards''; removing the entry under that heading; 
and adding a new entry to read as follows:


Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

[[Page 45732]]



------------------------------------------------------------------------
                   40 CFR citation                      OMB control no.
------------------------------------------------------------------------
                                * * * * *

------------------------------------------------------------------------
             Registration Standards and Registration Review
------------------------------------------------------------------------
                                * * * * *
Part 155.............................................          2070-0057
------------------------------------------------------------------------

* * * * *
0
2. Part 155 is amended as follows:

PART 155-REGISTRATION STANDARDS AND REGISTRATION REVIEW

0
a. The authority citation for part 155 continues to read as follows:

    Authority: 7 U.S.C. 1361.

0
b. By revising the heading of part 155 to read as set forth above.
0
c. By adding a new subpart C to read as follows:

Subpart C--Registration Review Procedures

Sec.
155.40 General.
155.42 Registration review cases.
155.44 Establish schedules for registration review.
155.46 Deciding that a registration review is complete and 
additional review is not needed.
155.48 Data Call-In.
155.50 Initiate a pesticide's registration review.
155.52 Stakeholder engagement.
155.53 Conduct of a pesticide's registration review.
155.56 Interim registration review decision.
155.57 Registration review decision.
155.58 Procedures for issuing a decision on a registration review 
case.

Subpart C--Registration Review Procedures


Sec.  155.40  General.

    (a) Purpose. These regulations establish procedures for the 
registration review program required in FIFRA 3(g). Registration review 
is the periodic review of a pesticide's registration to ensure that 
each pesticide registration continues to satisfy the FIFRA standard for 
registration. The goal of the registration review procedures is review 
of each pesticide's registration every 15 years.
    (1) Among other things, FIFRA requires that a pesticide generally 
will not cause unreasonable adverse effects on the environment. 
Registration review is intended to ensure that each pesticide's 
registration is based on current scientific and other knowledge 
regarding the pesticide, including its effects on human health and the 
environment.
    (2) If a product fails to satisfy the FIFRA standard for 
registration, the product's registration may be subject to cancellation 
or other remedies under FIFRA.
    (b) Applicability. This subpart applies to every pesticide product 
registered under FIFRA section 3 as well as all pesticide products 
registered under FIFRA section 24(c). It does not apply to products 
whose sale or distribution is authorized under FIFRA section 5 or 
section 18.
    (c) Limitations. (1) At any time, the Agency may undertake any 
other review of a pesticide under FIFRA, irrespective of the 
pesticide's past, ongoing, scheduled, or not yet scheduled registration 
review.
    (2) When the Agency determines that new data or information are 
necessary for a pesticide's registration review, it will require such 
data under FIFRA section 3(c)(2)(B).


Sec.  155.42  Registration review cases.

    (a) Establishing registration review cases. A registration review 
case will be composed of one or more active ingredients and all the 
products containing such ingredient(s). The Agency may group related 
active ingredients into a registration review case when the active 
ingredients are so closely related in chemical structure and 
toxicological profile as to allow common use of some or all required 
data for hazard assessment.
    (1) Existing pesticides. The Agency will assign each pesticide 
registered on or before the effective date of this regulation to a 
registration review case.
    (2) New pesticides. The Agency will assign each pesticide 
registered after the effective date of this regulation to an existing 
registration review case or to a new registration review case.
    (3) A pesticide product that contains multiple active ingredients 
will belong to the registration review cases for each of its active 
ingredients.
    (b) Modifying registration review cases. New data or information 
may suggest that a registration review case should be modified. The 
Agency may modify a registration review case in the following ways:
    (1) Add a new active ingredient to a registration review case. The 
Agency may determine that a new active ingredient is chemically and 
toxicologically similar to active ingredients in an existing 
registration review case and should be grouped with the ingredients in 
the existing registration review case.
    (2) Split a registration review case into two or more registration 
review cases. For example, new data or information may suggest that 
active ingredients in a registration review case are not as similar as 
previously believed and that they belong in two or more separate 
registration review cases.
    (3) Move an ingredient from one registration review case to 
another. For example, new data or information might suggest that an 
ingredient should not be grouped with the other ingredients in the 
registration review case and that it belongs in a different 
registration review case.
    (4) Merge two or more registration review cases into a single 
registration review case. For example, new data or information might 
suggest that the active ingredients in two or more registration review 
cases should be grouped together for registration review.
    (5) Delete an active ingredient from a registration review case. 
For example, the Agency will remove the ingredient from the case if the 
registrations of all products containing an active ingredient in a 
registration review case are canceled.
    (c) Closing a registration review case. The Agency will close a 
registration review case if all products in the case are canceled.
    (d) Establishing a baseline date for a registration review case. 
For the purpose of scheduling registration reviews, the Agency will 
establish a baseline date for each registration review case. In 
general, the baseline date will be the date of initial registration of 
the oldest pesticide product in the case or the date of reregistration, 
whichever is later. For the purpose of these procedures, the date of 
reregistration is the date on which the Reregistration Eligibility 
Decision or Interim Reregistration Decision was signed, whichever date 
the Agency determines to be more appropriate based on the 
comprehensiveness of the review.
    (1) The Agency generally will not change the baseline date for a 
registration review case when it modifies a case by adding or deleting 
ingredients or products.
    (2) When the Agency splits a registration review case into two or 
more cases, the new case(s) generally will have the baseline date of 
the original registration review case.
    (3) When the Agency merges two or more registration review cases 
into a single case, the Agency generally will use the earliest baseline 
date as the baseline date for the new case.
    (e) Announcing registration review cases and baseline dates. The 
Agency will maintain a list of registration review cases, including 
baseline dates, on its website.

[[Page 45733]]

Sec.  155.44  Establish schedules for registration review.

    The Agency will develop schedules for registration review that are 
generally based on the baseline date of the registration review case or 
on the date of the latest registration review of the registration 
review case. The Agency may also take into account other factors, such 
as achieving process efficiencies by reviewing related cases together, 
when developing schedules for registration review. The Agency will 
maintain schedules for the current year and at least two subsequent 
years on its website.


Sec.  155.46  Deciding that a registration review is complete and 
additional review is not needed.

    The Agency may determine that there is no need to reconsider a 
previous decision that a pesticide satisfies the standard of 
registration in FIFRA. In such cases, instead of establishing a 
pesticide registration review case docket as described in Sec.  155.50, 
the Agency may propose that, based on its determination that a 
pesticide meets the FIFRA standard for registration, no further review 
will be necessary. In such circumstances, the Agency will publish a 
notice in the Federal Register announcing the availability of the 
proposed decision and provide a comment period of at least 60 calendar 
days. The Agency will publish a notice in the Federal Register 
announcing the availability of a final version of the decision, an 
explanation of any changes to the proposed decision and its response to 
any comments. The date of the final notice of availability would be 
used as the date of the latest registration review for the purpose of 
scheduling subsequent registration reviews.


Sec.  155.48  Data Call-In.

    The Agency may issue a Data Call-In notice under FIFRA section 
3(c)(2)(B) at any time if the Agency believes that the data are needed 
to conduct the registration review. The provisions in FIFRA section 
3(c)(1), (c)(2)(B), and (c)(2)(D) apply to the submission, 
compensation, and exemption of data required to conduct a registration 
review.


Sec.  155.50  Initiate a pesticide's registration review.

    The Agency will initiate a pesticide's registration review by 
establishing a docket for each registration review case, except for 
cases covered under Sec.  155.46, and opening it for public review.
    (a) Contents of the registration review case docket. The Agency 
will place in this docket information that will assist the public in 
understanding the types of information and issues that the Agency may 
consider in the course of the registration review. The Agency may 
include information from its files including, but not limited to, the 
following information:
    (1) An overview of registration review case status;
    (2) A list of current registrations and registrants, any Federal 
Register notices regarding pending registration actions, and current or 
pending tolerances;
    (3) Risk assessment documents;
    (4) Bibliographies concerning current registrations;
    (5) Summaries of incident data; and
    (6) Any other pertinent data or information.
    (b) Public review of the registration review case docket. The 
Agency will publish a notice in the Federal Register announcing the 
availability for public review of the information described in 
paragraph (a) of this section and establishing a comment period of at 
least 60 days. During this comment period, interested persons may 
identify any additional information they believe the Agency should 
consider in the course of the registration review.
    (c) Submission of data and other information during the comment 
period. The Agency may identify, either in the notice published under 
paragraph (b) of this section, or at any other time, data or 
information that it does not have but which may be useful, if 
available, for consideration in the registration review. Any person may 
submit data or information in response to such identification. In order 
to be considered during a pesticide's registration review, the 
submitted data or information must meet the requirements listed below.
    (1) In order to ensure that the Agency will consider data or 
information in the conduct of a registration review, interested persons 
must submit the data or information during the comment period 
established in the notice described in paragraph (b) of this section. 
The Agency may, at its discretion, consider data or information 
submitted at a later date.
    (2) The data or information must be presented in a legible and 
useable form. For example, an English translation must accompany any 
material that is not in English and a written transcript must accompany 
any information submitted as an audiographic or videographic record. 
Written material may be submitted in paper or electronic form.
    (3) Submitters must clearly identify the source of any submitted 
data or information.
    (4) Submitters may request the Agency to reconsider data or 
information that the Agency rejected in a previous review. However, 
submitters must explain why they believe the Agency should reconsider 
the data or information in the pesticide's registration review.
    (d) For the purposes of this subpart, the provisions of subpart B 
do not apply.


Sec.  155.52  Stakeholder engagement.

    In addition to the public participation opportunities described in 
Sec.  155.50 and Sec.  155.53(c), the Agency may meet with stakeholders 
regarding a forthcoming or ongoing registration review. For example, 
before conducting a pesticide's registration review, the Agency may 
consult with registrants or pesticide users regarding the use and usage 
of the pesticide. The Agency may consult with registrants, pesticide 
users, or other persons during a pesticide's registration review with 
regard to developing risk management options for a pesticide. The 
Agency may informally consult with officials of Federal, State or 
Tribal agencies regarding a forthcoming or ongoing registration review.
    (a) Minutes of meetings with persons outside of government. The 
Agency will place in the docket minutes of meetings with persons 
outside of government where the primary purpose of the meeting is to 
discuss a forthcoming or ongoing registration review. The Agency will 
place minutes of such meetings in the docket when it takes action under 
Sec.  155.58. At its discretion, the Agency may place minutes of such 
meetings in the docket sooner.
    (b) Exchange of documents or other written material. In the course 
of a meeting with a person outside of government, the Agency or that 
person may provide the other with a copy of a document or other written 
material that has not yet been released to the public. The Agency will 
place a copy of any such document or other written material in the 
docket along with the minutes of the meeting where the materials were 
exchanged.
    (c) Confidential business information. The Agency will not place 
confidential business information in the docket.


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

[[Page 45734]]

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 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.


Sec.  155.56  Interim registration review decision.

    The Agency may issue, when it determines it to be appropriate, an 
interim registration review decision before completing a registration 
review. Among other things, the interim registration review decision 
may require new risk mitigation measures, impose interim risk 
mitigation measures, identify data or information required to complete 
the review, and include schedules for submitting the required data, 
conducting the new risk assessment and completing the registration 
review. A FIFRA 3(c)(2)(B) notice requiring the needed data or 
information may precede, accompany, or follow issuance of the interim 
registration review decision. The Agency will follow procedures in 
Sec.  155.58 when issuing an interim registration review decision.


Sec.  155.57  Registration review decision.

    A registration review decision is the Agency's determination 
whether a pesticide meets, or does not meet, the standard for 
registration in FIFRA.


Sec.  155.58  Procedures for issuing a decision on a registration 
review case.

    (a) The Agency will publish a notice in the Federal Register 
announcing the availability of a proposed registration review decision 
or a proposed interim registration review decision. At that time, the 
Agency will place in the pesticide's registration review docket the 
Agency's proposed decision and the bases for the decision. There will 
be a comment period of at least 60 calendar days on the proposed 
decision.
    (b) In its proposed decision, the Agency will, among other things:
    (1) State its proposed findings with respect to the FIFRA standard 
for registration and describe the basis for such proposed findings.
    (2) Identify proposed risk mitigation measures or other remedies as 
needed and describe the basis for such proposed requirements.
    (3) State whether it believes that additional data are needed and, 
if so, describe what is needed. A FIFRA 3(c)(2)(B) notice requiring 
such data may be issued in conjunction with a proposed or final 
decision on the registration review case or a proposed or final interim 
decision on a registration review case.
    (4) Specify proposed labeling changes; and
    (5) Identify deadlines that it intends to set for completing any 
required actions.
    (c) After considering any comments on the proposed decision, the 
Agency will issue a registration review decision or interim 
registration review decision. This decision will include an explanation 
of any changes to the proposed decision and the Agency's response to 
significant comments. The Agency will publish a notice in the Federal 
Register announcing the availability of a registration review decision 
or interim registration review decision. The registration review case 
docket will remain open until all actions required in the final 
decision on the registration review case have been completed.
    (d) If the registrant fails to take the action required in a 
registration review decision or interim registration review decision, 
the Agency may take appropriate action under FIFRA.

[FR Doc. E6-12904 Filed 8-8-06; 8:45 am]

BILLING CODE 6560-50-S
