Pesticides; Procedural Regulations for Registration Review, 45720-45734 [E6-12904]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 71, Number 153 (Wednesday, August 9, 2006)]
[Rules and Regulations]
[Pages 45720-45734]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12904]



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Part IV





 Environmental Protection Agency





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40 CFR Parts 9 and 155



 Pesticides; Procedural Regulations for Registration Review; Final Rule

Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / 
Rules and Regulations

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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.

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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 https://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 https://
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 https://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 https://
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

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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: https://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.

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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

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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

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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: https://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 fi