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Wednesday,

August 9, 2006

Part IV

Environmental
Protection Agency
40 CFR Parts 9 and 155
Pesticides; Procedural Regulations for
Registration Review; Final Rule
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45720 Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Rules and Regulations

ENVIRONMENTAL PROTECTION of operation of this Docket Facility are II. Overview of this Document
AGENCY from 8:30 a.m. to 4 p.m., Monday In this document, EPA presents its
through Friday, excluding legal response to comments on the proposed
40 CFR Parts 9 and 155 holidays. The Docket Facility telephone rule to establish procedural regulations
[EPA–HQ–OPP–2004–0404; FRL–8080–4] number is (703) 305–5805. for the registration review of pesticides.
FOR FURTHER INFORMATION CONTACT: In response to comments, EPA is
RIN 2070–AD29 Vivian Prunier, Field and External modifying some aspects of the rule
Pesticides; Procedural Regulations for Affairs Division (7506P), Office of relating to procedures for public
Registration Review Pesticide Programs, Environmental participation in the registration review
Protection Agency, 1200 Pennsylvania process. The differences between the
AGENCY: Environmental Protection Ave., NW., Washington, DC 20460– proposed rule and the final rule are
Agency (EPA). 0001; telephone number: 703–308–9341; described in Units VI. and X.
ACTION: Final rule. fax number: 703–305–5884; e-mail In this document, the Agency
address: prunier.vivian@epa.gov. describes:
SUMMARY: This rule establishes
SUPPLEMENTARY INFORMATION: • Statutory authority.
procedures for conducting the pesticide
I. General Information • History of this rulemaking.
registration review program mandated
• Response to comments on the rule.
by the Federal Insecticide, Fungicide, A. Does this Action Apply to Me? • Response to comments on the
and Rodenticide Act. Under this rule,
You may be potentially affected by operation and implementation of the
EPA will review existing pesticide
this action if you hold pesticide program.
registrations to determine whether they
registrations. Pesticide users or other • Results of reviews required by
continue to meet the statutory standard
persons interested in the regulation of statutes or executive orders.
for registration. The registration review
the sale, distribution or use of pesticides • Changes to the rule.
program will begin in the fall of 2006.
may also be interested in this • Procedural regulations for the
This rule provides for the establishment
procedural regulation. Potentially registration review of pesticides.
of pesticide cases for review, the
scheduling of reviews, the initiation, affected entities may include, but are III. Authority
completion and documentation of not limited to:
• Producers of pesticide products A. EPA’s Authority to License Pesticides
reviews, and associated public
participation procedures. The (NAICS code 32532). FIFRA section 3(a) generally requires
registration review program established • Producers of antifoulant paints a person to register a pesticide product
by this regulation is intended to ensure (NAICS code 32551). with the EPA before the pesticide
that all pesticide registrations are • Producers of antimicrobial product may be lawfully distributed or
systematically reviewed in a manner pesticides (NAICS code 32561). sold in the U.S. A pesticide registration
• Producers of nitrogen stabilizer is a license that allows a pesticide
that is based on sound science and
products (NAICS code 32531). product to be distributed or sold for
provides for public participation,
• Producers of wood preservatives specific uses under specified terms and
transparency and efficiency to protect
(NAICS code 32519). conditions. A pesticide product may be
public health and the environment. In This listing is not intended to be
addition, in order to display the OMB registered or remain registered only if it
exhaustive, but rather provides a guide meets the statutory standard for
control number for the information for readers regarding entities likely to be
collection requirements contained in registration given in FIFRA section
affected by this action. Other types of 3(c)(5), as follows:
this final rule, EPA is amending the entities not listed in this unit could also
table of OMB approval numbers for EPA be affected. The North American (A) its composition is such as to warrant
regulations. Industrial Classification System the proposed claims for it;
DATES: This final rule is effective on (B) its labeling and other material required
(NAICS) codes have been provided to to be submitted comply with the
October 10, 2006. assist you and others in determining requirements of this Act;
ADDRESSES: EPA has established a whether this action might apply to (C) it will perform its intended function
docket for this action under Docket certain entities. To determine whether without unreasonable adverse effects on the
identification (ID) number EPA–HQ– you or your business may be affected by environment; and
OPP–2004–0404. All documents in the this action, you should carefully (D) when used in accordance with
docket are listed in the docket index at examine the applicability provisions in widespread and commonly recognized
http://www.regulations.gov. Although § 155.40 of the rule. If you have any practice it will not generally cause
listed in the index, some information is questions regarding the applicability of unreasonable adverse effects on the
not publicly available, e.g., CBI or other environment.
this action to a particular entity, consult
information whose disclosure is the person listed under FOR FURTHER FIFRA 2(bb) defines ‘‘unreasonable
restricted by statute. Certain other INFORMATION CONTACT. adverse effects on the environment’’ as
material, such as copyrighted material, (1) any unreasonable risk to man or the
is not placed on the Internet and will be B. How Can I Access Electronic Copies
of this Document and Other Related environment, taking into account the
publicly available only in hard copy economic, social, and environmental costs
form. Publicly available docket Information? and benefits of the use of any pesticide, or
materials are available either in the In addition to using http:// (2) a human dietary risk from residues that
electronic docket at http:// www.regulations.gov to access this result from a use of a pesticide in or on any
www.regulations.gov, or, if only document and other related information food inconsistent with the standard under
section 408 of the Federal Food, Drug, and
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available in hard copy, at the Office of in the electronic docket, you may access
Pesticide Programs (OPP) Regulatory this Federal Register document Cosmetic Act.
Public Docket in Rm. S–4400, One electronically through the EPA Internet The burden to demonstrate that a
Potomac Yard (South Bldg.), 2777 S. under the ‘‘Federal Register’’ listings at pesticide product satisfies the criteria
Crystal Drive, Arlington, VA. The hours http://www.epa.gov/fedrgstr/. for registration is at all times on the

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Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Rules and Regulations 45721

proponents of initial or continued • Results of reviews required by registration review. They asserted that
registration. (Industrial Union Dept. v. statutes and executive orders. in the absence of specific procedures in
American Petroleum Institute, 448 U.S. FIFRA for the administration of
V. Overview of Comments
607, 653 n. 61 (1980); Environmental registration review, EPA must use
Defense Fund v. Environmental EPA received 23 comments on the procedures in FIFRA section 3(c)(8)
Protection Agency, 510 F.2d 1292, 1297, proposed rule, as follows: which specifies procedures for
1302 (D.C. Cir. 1975). • One individual. conducting interim administrative
• Two consultants. review to develop a risk-benefit
B. EPA’s Authority for Registration • One public interest group. evaluation of a pesticide. Procedures for
Review • Four registrants. implementing FIFRA section 3(c)(8) are
The Food Quality Protection Act • One State Pesticide Safety described in 40 CFR part 154.
(FQPA) of 1996 amended FIFRA to add, Coordinator. The Agency does not agree with this
among other things, section 3(g), • Three State Lead Agencies for comment. FIFRA section 3(g)(1)(A),
‘‘REGISTRATION REVIEW,’’ as follows: pesticides. which mandates a periodic review of
(1)(A) GENERAL RULE. - The registrations • Five California water sanitation the registration of pesticides, requires
of pesticides are to be periodically reviewed. agencies. the Agency to establish procedures for
The Administrator shall by regulation • Six trade associations. conducting such reviews. This
establish a procedure for accomplishing the The Agency’s analysis of these provision means that, except for
periodic review of registrations. The goal of comments showed that the comments limitations specified in FIFRA section
these regulations shall be a review of a can be organized into three broad topic 3(g)(1)(B) and FIFRA 3(g)(2), EPA has
pesticide’s registration every 15 years. No areas: the authority to develop procedures for
registration shall be canceled as a result of
the registration review process unless the
• Requests for changes in the the conduct of this new program.
Administrator follows the procedures and procedural regulations. These comments Accordingly, EPA is not required to use
substantive requirements of section 6. and the Agency’s response are discussed procedures in FIFRA section 3(c)(8) to
(B) LIMITATION. - Nothing in this in this preamble. conduct the review mandated in FIFRA
subsection shall prohibit the Administrator • Operation and implementation of section 3(g).
from undertaking any other review of a the registration review program. These 2. Registration review of pesticides
pesticide pursuant to this Act. comments and the Agency’s response covered under FIFRA section 25(b). An
(2)(A) DATA. - The Administrator shall use are discussed in this preamble. industry comment asked EPA to assure
the authority in subsection (c)(2)(B) to • Issues concerning the licensing of that products exempted from FIFRA
require the submission of data when such regulation under section 25(b) of FIFRA
data are necessary for a registration review.
pesticides in general are described in
the response to comments document are reviewed adequately, especially
(B) DATA SUBMISSION, with regards to health claims.
COMPENSATION, AND EXEMPTION. - For that the Agency has placed in the docket
for this rulemaking. Pesticides that are exempt from
purposes of this subsection, the provisions of
subsections (c)(1), (c)(2)(B), and (c)(2)(D) In general, comments on the proposed FIFRA requirements under FIFRA
shall be utilized for and be applicable to any rule resulted in minimal revisions in the section 25(b) are identified in 40 CFR
data required for registration review. final rule. Early implementation will 152.20, Exemptions for pesticides
continue to be discussed with the regulated by another Federal agency,
IV. Notice of Proposed Rulemaking Pesticide Program Dialogue Committee, and 40 CFR 152.25, Exemptions for
EPA published proposed procedures a stakeholder advisory committee pesticides of a character not requiring
for the registration review of pesticides established under the Federal Advisory FIFRA regulation. Pesticides covered by
on July 13, 2005 (70 FR 40251) (FRL– Committee Act. EPA may issue FIFRA section 25(b) are not subject to
7718–4). A copy of the proposed rule additional guidance on the registration registration review. However, some
may be found in Docket EPA–HQ–OPP– review program as it gains experience products that are exempt under FIFRA
2004–0404, which can be accessed with these procedures. section 25(b) could be affected by
electronically at: http:// actions taken in registration review. For
VI. Comments on the Procedural example, pesticide-treated articles or
www.regulations.gov. The 90–day
Regulations substances described in § 152.25(a)
comment period for this proposed rule
ended on October 11, 2005. A. § 155.40--General could be affected if issues arise during
The preamble to the proposed rule the registration review of a pesticide
This section describes the purpose of used to treat an article or substance. If
discussed:
the regulations in Subpart C-- the pesticide product or its use on
• Statutory authority and legislative
Registration Review Procedures and treated articles or substances were
history.
• The Agency’s goals for the states that the goal of these procedures canceled, the treated article or substance
registration review program. is a review of each pesticide’s would no longer meet the requirements
• Evaluating approaches to registration every 15 years. This section of § 152.25(a), which specifies that the
registration review. also specifies that the regulations apply pesticide used to treat an article or
• Factors considered in designing the to pesticides registered under section 3 substance must be registered for that
registration review program. or section 24(c) of FIFRA, states that the use.
• Design options considered for the Agency may undertake any other review
under FIFRA at any time and that the B. § 155.42--Baseline Dates for
registration review program.
Registration Review Cases
• Testing the proposed registration Agency will use FIFRA section
review decision process. 3(c)(2)(B) to require new data or In § 155.42(d), EPA proposed to
• Proposed procedures for information that are necessary for a establish a baseline date for each
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registration review. pesticide’s registration review. registration review case. In general, the
• Relationship of registration review 1. Authority to establish procedures baseline date would be the date of
to other FIFRA activities. for registration review. A trade initial registration of the oldest product
• Phase-in of the registration review association questioned EPA’s authority in the registration review case or the
program. to establish the proposed procedures for date of reregistration, whichever is later.

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45722 Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Rules and Regulations

The date of reregistration would be the Agency might consider. In July 2006, The Agency has a continuing
date on which either a Reregistration EPA released draft schedules that were obligation to respond to emerging risk
Eligibility Decision (RED) or an Interim developed using procedures in the concerns (discussed in Unit XI.B. of the
Reregistration Eligibility Decision proposed rule. Under the draft preamble of the proposed rule). At any
(IRED) was signed, whichever date the schedules, EPA would review time, the Agency may receive new
Agency determines to be most chemically related registration review information that suggests that the
appropriate. cases together. Agency should reevaluate a previous
An industry comment suggested that While most commenters supported decision to register a pesticide. After the
to avoid duplication of effort, the the proposed chronological approach, registration review program begins, the
Agency should amend § 155.42 to use public interest groups and water Agency will continue to address
the date of approval of significant new treatment authorities advocated risk- emerging risk concerns. If a pesticide
uses as the baseline date for the based approaches for scheduling. presents an urgent potential risk of
registration review case. Several industry groups did not like the concern, the Agency may opt to review
The Agency intended the baseline chemical groupings in the Agency’s all other aspects of the pesticide’s
date to be the date of the last draft schedules, preferring that cases be registration at that time, rather than only
comprehensive review. A review of a scheduled for registration review in a looking at the risk of concern. In such
new use may not be comprehensive-- strictly chronological order. They cases, the Agency may update the
previously approved uses may not be argued that grouping cases together registration review schedule by
included in the evaluation of the new undermines the chronological order of announcing the new date of the
use. Generally, when conducting a the schedule and that the order of registration review of this case.
registration review of a pesticide for groups in the schedule would be based In general, the Agency may consider
which a significant new use was on risk concerns. One industry group these and other factors, including issues
recently approved, EPA would not redo asked the Agency to include in the rule raised by the public or the registrant
the recent review but would incorporate criteria for deviating from a when reviewing a posted schedule, to
the risk assessment for the new use into chronologically based schedule and to schedule a pesticide registration review,
the registration review. or to modify the schedule of a pesticide
consult registrants regarding the
Another commenter asserted that registration review as appropriate.
selection of new dates.
baseline dates should be either the 3. Three-year schedules. Although the
initial registration of a pesticide or the While the Agency appreciates that preamble of the proposed rule
completion of the RED. The commenter there is a range of views as to how to contemplated maintaining a 3–year
stated that the IRED should not be used set schedules for the registration review schedule, the proposed rule did not
because it does not include an program, the establishment of schedules specify a timeframe. In response to
assessment of cumulative risk that is is within the Agency’s discretion. EPA comments requesting this change, the
required for pesticides that have a believes that reviewing similar cases Agency has modified § 155.44 to specify
common mechanism of toxicity with together facilitates decision making for that the schedules would cover the
other substances. For such pesticides, pesticides with similar scientific or current year and at least two subsequent
the Agency should use the date of the regulatory issues and would be an years.
RED (as opposed to IRED) to establish a efficient use of resources. Registrants or
other stakeholders may notify the D. § 155.46--Deciding that a Registration
common baseline date for all the
Agency regarding particular issues that Review is Complete and Additional
pesticides included in the cumulative
could impact the schedule. The Agency Review is Not Needed
risk assessment.
The Agency agrees that the RED would consider such issues as Under § 155.46, the Agency may
would update the comprehensive IRED appropriate. propose that no additional review of a
regarding cumulative risk or other 2. Considerations that could change pesticide is needed in order to
issues but the RED itself may not be a the registration review schedule. The determine whether the pesticide
comprehensive review. For cases where Agency may consider factors other than continues to meet FIFRA requirements
there is both an IRED and a RED, the the baseline date of the registration for registration. The Agency would
Agency needs the flexibility to decide review case when developing schedules announce the availability of such
which document represents a for registration review. As discussed in proposals and take comment on them.
comprehensive review. Accordingly, Unit IX.E. of the preamble of the In response to comments on a proposal
this final rule allows the Agency to use proposed rule and as shown on the draft made under § 155.46, EPA may
the date of either document as the schedule released in July 2005, the reconsider its proposal and schedule a
baseline date. Agency plans to cluster identified cases registration review of the pesticide.
belonging to the same chemical class or The Agency received one comment
C. § 155.44--Establishing and group to promote efficiency of review asking the Agency to clarify the purpose
Announcing Schedules for Registration for the Agency and provide a ‘‘level of this provision. The purpose of this
Review playing field’’ for industry. provision is to give the Agency
1. Chronological vs. risk-based criteria Additionally, because the Agency’s flexibility to not schedule a pesticide for
as basis for establishing schedules for economic analysis of this regulation registration review if the pesticide has
registration review. In § 155.44, EPA suggested that a small business (i.e., a such low toxicity, exposure or risk that
proposed that schedules would be based business that meets criteria established another review would not change the
on the baseline date of the registration by the Small Business Administration) Agency’s position and would not be an
review case or on the date of the last might face high data generation costs if effective use of resources. The Agency
registration review of the registration it holds registrations in two or more may also use this provision for a
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review case. The rule allows the Agency registration review cases that are pesticide that has recently undergone a
to take into account other factors, such scheduled to undergo registration comprehensive review. In proposed
as achieving process efficiencies, when review in the same year, the Agency decisions issued under § 155.46, the
setting schedules. The preamble of the may schedule these cases out of Agency generally would explain why it
proposal described other factors that the chronological order. believes that no additional review is

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necessary and reference, as appropriate, standard, EPA should assure that the F. § 155.50--Initiate a Pesticide’s
publicly available documentation to registrant of the pesticide is entitled to Registration Review
support the Agency’s position. use data supporting the risk/benefit EPA proposed to establish a docket
To clarify the procedures it will use determination for the pesticide. for each registration review case, except
in § 155.46, EPA is modifying the
The Agency acknowledges the for cases covered under § 155.46. The
second sentence to read, ‘‘In such cases,
importance of this issue and agrees that docket would describe information that
instead of establishing a pesticide
this concern should be addressed in the the Agency may consider in the course
registration review case docket as
conduct of the registration review of a pesticide’s registration review and
described in § 155.50, the Agency may
program. FIFRA section 3(g)(2)(A) describe information that the Agency
propose that, based on its determination
directs the Agency to utilize section does not have that might be useful in
that a pesticide meets the FIFRA
3(c)(2)(B) to require the submission of the review. The public would be invited
standard for registration, no further
review will be necessary.’’ EPA is data when such data are necessary for to review information in the docket and
clarifying the status of pesticides subject a registration review. Similarly, FIFRA submit, within 60 days, any other
to this section by adding the sentence, section 3(g) requires that the data information that they believe should be
‘‘The date of the final notice of compensation provisions, including considered in the pesticide’s review. A
availability would be used as the date of those set forth in sections 3(c)(1), pesticide’s registration review begins
the latest registration review for the 3(c)(2)(B), and 3(c)(2)(D) ‘‘be utilized for when EPA opens the docket for
purpose of scheduling subsequent and applicable to any data required for registration review case.
registration reviews.’’ registration review.’’ Hence, to the 1. Timeframe for submitting
extent the Agency requires any data for comments. As originally proposed, the
E. § 155.48--Data Call-In registration review, such data are timeframe for submitting comments in
Section 155.48 provides that, as eligible for the data protections response to a notice issued under
required by FIFRA section 3(g), EPA provided by the statute. § 155.50(b) would be ‘‘60 calendar
will use procedures in FIFRA section days.’’ In response to comments that
If a company submits data or
3(c)(2)(B) to require submission of data this time frame would not be long
information to the docket voluntarily (as
that are needed to conduct a pesticide’s enough, the Agency is modifying this
opposed to providing these data or
registration review. This paragraph paragraph to specify that the time frame
information in response to a DCI), such
stipulates that the data protection for such comment periods will be ‘‘at
data are not ‘‘required’’ data eligible for
provisions of FIFRA 3(c)(1), (c)(2)(B), least 60 calendar days.’’
protection under the statute. However, 2. Late submissions. Comments from
and (c)(2)(D) apply to the submission, the Agency may evaluate these data or
compensation and exemption of data industry and others asked the Agency to
information and find that it must rely on clarify its position regarding data or
required to conduct a registration this information to support the
review. information submitted after the due date
continued registration of pesticide established in the notice announcing the
1. Data Call-In procedures. One
products. If the Agency makes such a opening of the pesticide registration
comment asked why the proposed rule
finding in the course of a pesticide’s review case docket.
does not impose any requirements
registration review, this finding would Under § 155.50(c)(1), the Agency will
under FIFRA 3(c)(2)(B). The commenter
be a determination that the voluntarily consider late submissions if the Agency
suggested that additional data collection
submitted data or information are now believes that the new data or
authorities are needed and procedures
required. This would be a ‘‘compensable information are critical for the
to ensure all necessary data must be
event’’ and would trigger the regulatory decision, such as health
included in this rule.
The Agency finds that it is not requirement for compensation to be effects or ecological effects data or
necessary to develop new procedures addressed. The competitors to the exposure data that the EPA could use to
for calling in data for registration review original submitter would be required to refine a risk assessment.
because FIFRA section 3(g) requires the submit their own data or offer data If a person has data or information
Agency to use section 3(c)(2)(B) to compensation to the data submitter for that he/she believes that Agency should
collect the data, and that section use of the study. A ‘‘compensable consider during the pesticide’s
provides EPA with sufficient authority event’’ would also arise should the registration review, but the data or
to obtain any necessary data. Agency issue a Data Call-In Notice for information will not become available
2. Data compensation for the same data as were previously before the expiration of the comment
‘‘voluntarily’’ submitted data. Industry submitted voluntarily, but a Data Call- period, he/she may either request an
comments asked that the proposed rule In Notice is not necessary to trigger extension of the comment period, or in
clarify the data compensation status of compensability should the Agency accordance with § 155.52, consult with
information voluntarily submitted in determine and announce as part of its the Agency regarding a submission date
response to registration review. Some registration review decision that the for these materials.
comments suggested that the rule particular data were required to support 3. Information submitted under
specify the mechanisms for requesting the registrations in question. § 155.50(c). Comments from industry
and obtaining a Data Call-In notice (DCI) The Agency’s registration review asked the Agency to modify § 155.50(c)
before the data are submitted in order to decision document may identify such to specify the types of information that
protect data compensation rights. Other data or information and the registration might be submitted under this
comments suggested that studies used review decision document may paragraph and to reference quality and
in the registration review decision, establish a deadline for registrants scientific criteria for data that might be
particularly studies generated under whose registrations depend on such submitted as comments during a
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revisions to the data requirements in 40 data to offer compensation to the pesticide’s registration review.
CFR part 158, be presented in the owners of the data or submit their own In the preamble of the proposed rule,
decision document. Registrants asked data. The Agency may cancel the EPA described the kinds of information
that in addition to determining whether product registration of registrants who that, based on its experience in the
a pesticide meets the FIFRA risk/benefit fail to adequately support a registration. pesticide reregistration program, might

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45724 Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Rules and Regulations

be useful in registration review. As the changes in statutes and regulations, risk individual product registrations. The
Agency and its stakeholders gain assessment procedures or methods, or Agency will continue to comply with its
experience in the registration review data requirements and any new data protection obligations under FIFRA
process, it may become clear what types information about the pesticide to section 3(c)(2)(D).
of information are most useful. EPA determine whether additional review of 3. Public participation procedures.
could then develop appropriate the pesticide is warranted. If a new Several commenters noted that under
guidance. In accordance with the Data review of the pesticide active the Agency’s procedures for public
Quality Act, EPA has already issued ingredients or individual products in a participation in the reregistration and
guidance regarding the quality of registration review case is needed, the tolerance reassessment programs, the
information that it relies upon for Agency will determine whether Agency may announce the availability
regulatory decisions. This guidance is additional information is necessary to of a revised risk assessment and may
available at EPA’s website at: http:// conduct the review. This section also invite the public to suggest approaches
www.epa.gov/quality/ provides for public review and for mitigating the risks identified in the
informationguidelines/. The Agency comment during the review process. revised risk assessment. The proposed
will use this guidance in the registration Under the proposed procedures, the procedures for registration review did
review of pesticides. Agency would generally establish not provide this opportunity.
comment periods of ‘‘at least 60 In response to this comment, the
G. § 155.52--Stakeholder Engagement Agency is revising § 155.53(c) so that it
calendar days,’’ except in § 155.53(c)
Under § 155.52, the Agency may meet where the comment period is ‘‘at least may provide the public an opportunity
with registrants or other stakeholders 30 calendar days.’’ to comment on possible risk mitigation
during a pesticide’s registration review 1. Agency’s approach for conducting when a revised risk assessment shows
or to prepare for a forthcoming review. registration review. The Agency risks of concern. However, if immediate
This section explains the procedure for received several comments that action is warranted, the Agency may
releasing minutes or other material disagreed with the Agency’s proposed initiate cancellation or suspension
relating to such meetings. approach for conducting a pesticide’s procedures under FIFRA section 6. In
Comments from industry asked that registration review. An industry trade this event, the Agency would not
the rule provide an acceptable association reiterated comments made provide the opportunities for public
framework for activities in the pre- in response to the April 2000 Advance comment described in § 155.53(c) but
initiation stage. Other commenters Notice of Proposed Rulemaking (65 FR would follow procedures in FIFRA
remarked that non-registrants should 24585, April 26, 2000) (FRL–6488–9) section 6, as appropriate.
have more access to the registration that the Agency should use a checklist 4. Length of comment periods. Several
review process and that the public or decision tree for deciding whether a commenters asserted that the comment
should be able to view all information, pesticide continues to meet the periods provided in the proposed
including reports from consumers about requirements for registration. Other regulation were not long enough.
adverse effects. Additionally, they stakeholders expressed concern that the Generally, where EPA publishes a
asserted that EPA should announce proposed approach was not sufficiently document for comment, the Agency
consultation opportunities in the rigorous and would lead to relaxed considers requests for extension if a
Federal Register. Other comments from standards. reasonable basis for extension is
industry emphasized their concern that In the preamble of the proposed rule, provided. It is not necessary to modify
EPA not release confidential business the Agency described alternative these regulations to provide for
information. approaches for conducting a pesticide’s extending comment periods.
In this document, the Agency is registration review and explained why it
establishing procedures that provide the selected the proposed approach. The I. § 155.57--Registration Review Decision
public with the opportunity to comments do not raise issues or This section states that a registration
participate in the review process and to concerns that would alter EPA’s choice review decision is the Agency’s
review materials that the Agency uses as of approach. It is important to note, determination whether a pesticide
the basis of proposed registration review however, that although the Agency has meets, or does not meet, the standard for
decisions. not chosen to use a pure checklist registration under FIFRA.
The Agency generally does not approach, it is using a decision 1. Goal of registration review. The
announce in the Federal Register paradigm that ensures that the process California Stormwater Quality
meetings with registrants or other will be transparent while still providing Association asserted that the goal of
stakeholders because it needs the sufficient flexibility to allow for the registration review should be to protect
flexibility to hold such meetings when scope and depth of a particular review water quality and minimize the need to
the need arises. EPA may meet privately to be tailored to the circumstances of the mitigate pesticide impacts through
with industry to discuss proprietary or particular registration review case. Clean Water Act (CWA) mechanisms.
other confidential business information. 2. Review of individual product The Agency believes that the goal of
Under § 155.52(a) and (b), EPA will registrations. Some registrants expressed registration review is set forth in FIFRA
place in the docket minutes of meetings their belief that the Agency should section 3(g) and reiterated in § 155.40.
with registrants or other stakeholders. conduct a comprehensive review of Registration review is a determination
EPA’s protection of information claimed individual product registrations to whether a pesticide continues to meet
to be confidential business information assure adequacy of product labels, the FIFRA standard for registration,
is governed by section 10 of FIFRA and product-specific data, and any claims including, among other things, that the
the Agency’s regulations in 40 CFR part for generic data exemption under FIFRA pesticide does not cause unreasonable
2. section 3(c)(2)(D). effects on the environment. As part of
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As explained in the preamble of the this review, EPA will assess the effects
H. § 155.53--Conduct of a Pesticide’s proposed rule, during the comment of pesticides on water quality. However,
Registration Review period on the initial registration review while meeting CWA standards is
This section describes how the case docket, the public may comment important, it is not the only goal of
Agency will assess the significance of on the need for a new review of registration review.

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Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Rules and Regulations 45725

2. FIFRA standard for registration. (a) registered even though high risks are When a pesticide poses risks of
Comments from industry strongly associated with the use of the pesticide. concern to humans or the environment,
oppose EPA’s intention to consider a In its earlier review, the Agency may the Agency must address these risks.
pesticide’s benefits during registration have found that the pesticide did not The options for addressing such risks
review. The comments referred to a pose unreasonable risk because of the include risk mitigation, determining
discussion in the preamble of the high benefits of the pesticide. In that the risks are justified in light of the
proposed rule where EPA explained that registration review, EPA may find that benefits of the pesticide, or initiating
it would evaluate information about the existing risk assessments that identify regulatory options to modify or cancel
benefits of a pesticide with known high these risks of concern are still valid. the registration. EPA generally consults
risks during registration review if a new EPA would then determine whether the with registrants and other stakeholders
and safer alternative to a pesticide has pesticide continues to provide sufficient when deciding how to mitigate a risk. In
become available. The comments benefits to justify maintaining the addition, EPA has modified the
asserted that it is inappropriate for the registration. The benefits finding could proposed public participation
Agency to base continued registration of depend on whether new, safer procedures for registration review to
a pesticide on a comparative benefits alternatives have been registered since generally add a public comment period
assessment with other pesticides. The EPA’s earlier decision. EPA conducted when a pesticide poses risks of concerns
comments cited FIFRA section 3(c)(5) to similar analyses in the reregistration so members of the public can provide
support their assertion that when program. suggestions for reducing the risk. This
pesticides meet the registration criteria If EPA’s review of a pesticide’s procedure provides registrants and other
of FIFRA, the Agency should not be registration appears to show that the stakeholders an opportunity to provide
allowed to make marketplace decisions pesticide does not meet the FIFRA input on the Agency’s risk management
of one product over another. FIFRA standard for registration, EPA would decisions.
section 3(c)(5) states, ‘‘The follow procedures in FIFRA section 6 to
Administrator shall not make any lack J. § 155.58--Procedures for Issuing a
change, cancel or suspend the Decision on a Registration Review Case
of essentiality a criterion for denying pesticide’s registration. This section sets
registration of any pesticide. Where two out where it requires EPA to assess the In this section, EPA explains that it
pesticides meet the requirement of this benefits of the pesticide and provides will issue proposed registration review
paragraph, one should not be registered opportunities for public hearings on decision documents for public review
in preference to the other.’’ whether the pesticide’s registration and comment. In comments on the
EPA believes the commenter should be changed, canceled, or proposed rule, various stakeholders
misapprehends the nature of FIFRA’s suspended. The Agency would not advised the Agency of their expectations
risk-benefit balancing standard. A analyze benefits when a registrant and needs regarding the documentation
determination that a pesticide meets the of registration review decisions and
responds to the Agency’s registration
registration standard under FIFRA at suggested how this documentation
review finding by agreeing to the
one time does not necessarily mean that might be presented. EPA appreciates
cancellation of a pesticide or
the same pesticide will meet the these suggestions. The Agency has
termination of one or more of its uses
standard at all times in the future, even consulted the Pesticide Program
under FIFRA section 6(f). However,
if the science associated with the risks Dialogue Committee and has considered
FIFRA provides the public an
posed by the pesticide does not change. their recommendations together with
opportunity to comment on the
Significant changes in the benefits comments submitted on the proposed
proposed action.
picture, such as the development of pest procedural regulations. Nothing in the
resistance or new alternatives, can also (b) Another registrant asserted that the
registration review regulations should comments indicates the need to modify
affect whether a pesticide continues to the regulation to specify the format of
meet the FIFRA registration standard. contain language that specifically
reaffirms the standard of imminent the registration decision document.
EPA does not intend to compare
benefits of two or more pesticides that hazard and substantial risk as the basis VII. Comments on the Operation of the
do not pose risks of concern. As the for cancelling pesticide registrations. He Registration Review Program
commenters noted, EPA may not make cited a specific product example to
illustrate his belief that the Agency A. Scope of the Registration Review
a determination of essentiality when Program
two pesticides meet the FIFRA employed a ‘‘zero tolerance agenda’’
requirements for registration. However, during reregistration. 1. Is registration review a safety net?
when there are risks of concern for a The standard of ‘‘imminent hazard’’ In the preamble of the proposed rule,
pesticide, FIFRA requires EPA to weigh referred to by the commenter applies to the Agency described how it intended to
those risks against the benefits of that suspensions and emergency use registration review as the framework
pesticide to determine whether the risks suspensions under FIFRA section 6(c). for managing the regulatory status of
are unreasonable. Benefits are the This section sets forth the standard for existing pesticides.
advantages that accrue to the pesticide a suspension or an emergency Industry trade associations did not
users or society in general, such as suspension. This is not the standard that agree with this approach. In their
increased production, decreased the Agency will use in making comments, they asserted that EPA
production costs, pest-free homes, or registration review decisions. The should not expand registration review
disease-vector control. The magnitude Agency interprets registration review to beyond the intent of Congress because
of those benefits often depends on the be a determination that a pesticide to do so risks repeating the Agency’s
availability of alternative pest control continues to meet the standard for experience with reregistration which
measures, whether chemical, biological registration in FIFRA section 3(c)(5), or, began as a 5–year program in 1972 and
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or cultural. Benefits are, in general, where appropriate, section 3(c)(7). This still has not been completed. They
expected to be higher when there are no standard specifies, among other things, asserted that registration review should
viable alternatives. that a pesticide may not pose not be a catch-all for other programs and
During registration review, EPA may unreasonable risk to man or the actions. For example, special review,
reassess a pesticide that has remained environment. actions under FIFRA section 3(c)(8),

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

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data necessary to conduct a review and EPA believes that information on pesticide degradates have been found in
searching the published literature for water quality may be useful in drinking water supplies.
pertinent information about a pesticide. registration review and will make efforts The Office of Pesticide Programs
The Agency explained that early to obtain State data for CWA section (OPP) will manage water-related issues
acquisition of data or information that 303(d) listings due to pesticides. When within the framework of the registration
could be useful in refining a pesticide’s evaluating such data, EPA will take into review of pesticides. OPP expects that
risk assessment would reduce the time account the procedures used to develop its capacity for characterizing risk will
and effort needed to complete the the data to assess the quality and continue to improve as it works with the
review of a pesticide. As explained in usefulness of the data. Office of Water to refine its models for
the preamble, EPA might be able to estimating exposures and as more
identify data or information needs when C. Work-Sharing
monitoring data become available.
it publishes the schedule for a The preamble of the proposed rule
pesticide’s registration review. In some E. Achieving Label Improvement
described the Agency’s intention to
cases, data or information needs might through the Registration Review
develop work-sharing agreements with
become apparent when the Agency Program
its partners in the Organization for
assembles the initial docket for the Economic Cooperation and Several commenters see the
registration review case. In this event, Development (OECD) or the North registration review program as an
the docket for the registration review American Free Trade Agreement opportunity to improve the quality of
case would identify data or information (NAFTA). In comments on the proposed labels on individual pesticide products.
needs. In other cases, the Agency might rule, industry trade associations One aspect of label improvement would
not be able to identify data or expressed concern that conducting be to minimize the number of different
information needs until it evaluates the reviews jointly with EPA’s NAFTA or labels for the same product. According
information in the initial docket. OECD partners might cause delays. to comments, this situation arises
1. Identification of information that EPA continues to believe that because many States require State
may be used to refine risk assessments. harmonization and work-sharing will registration and impose their own
An industry trade group acknowledged result in process efficiencies and labeling requirements.
EPA’s concern about redoing risk superior decisions. Since EPA’s partners The Agency is committed to
assessments when, in response to a also have programs for reassessing improving the consistency of labels.
preliminary risk assessment, a registrant pesticides, all parties could benefit by EPA already works with States on
or other stakeholder submits new data coordinating their efforts. EPA and its labeling issues. However, the Agency
or information to refine the preliminary Canadian counterpart have begun notes that section 24(b) of FIFRA
risk assessment. However, they believe discussions for work-sharing during prohibits States from establishing or
that such iteration is inevitable. When registration review with the expectation maintaining labeling requirements. The
registrants conduct their own risk Agency agrees that label improvement is
that they will develop a work-sharing
assessments, they may use different a worthwhile goal for the registration
plan by the December 2006 meeting of
assumptions or interpretations of data review program.
the NAFTA Technical Working Group
than the Agency uses in its risk
on Pesticides. VIII. Implementation Issues
assessments. When the Agency’s risk
assessment shows higher risks than the EPA gave a presentation on the
registration review program at the A. Coordination of the Registration
registrants found in their own Review Rule with the Data Requirements
assessments, they must either develop February 2006 meeting of the OECD
Working Group on Pesticides. EPA Rule
data or information to refine the risk
assessment or cancel uses. intends to continue encouraging the Industry comments asserted that EPA
EPA agrees that some iteration may be OECD community to participate in should delay implementing registration
inevitable. However, the Agency work-sharing efforts. review until the recently proposed
publishes its risk assessment methods, EPA may adjust its schedule slightly revisions to the data requirements in 40
including its approach for interpreting to take advantage of these potential CFR part 158 have been finalized. They
data. So it may be possible for opportunities for work-sharing. stated their belief that EPA cannot make
registrants to anticipate the Agency’s registration review decisions until it has
D. Adequacy of EPA’s Methods for
information or data needs in a completed revising the data
Assessing Potential Risk to Water
forthcoming registration review and to requirements for the registration of
Quality
reduce the degree of iteration in the risk pesticides. Industry is concerned that if
assessment process. California water-treatment authorities registration review is initiated before a
2. Information developed under the questioned the adequacy of EPA’s final rule on data requirements,
Clean Water Act. In public discussions assessment of risks with regard to water different standards will apply to cases
about the proposed rule, EPA received quality considerations including: Use of reviewed early in the program, negating
a suggestion from water treatment aquatic toxicity testing, surface water one of the benefits of the review: to
authorities that the Agency might quality studies, and urban uses of reduce market barriers.
consider information developed under pesticides, particularly when these uses The Agency does not believe it is
section 303(d) of the Clean Water Act, result in pesticide residues in receiving appropriate to delay implementation of
which identifies impaired water bodies. waters for storm sewers or sewage the registration review program as
In comments, States raised the treatment plants. The commenters suggested in the comments. In the
concern that they do not have the reported that in some cases, pesticide absence of updated part 158 rules, the
resources to assemble such data. residues in water released by a sewage Agency makes case-by-case data
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Registrants expressed their concern that treatment plant may exceed its NPDES determinations as a standard program
these data not be taken at face value permit, which would be a violation of practice. Registrants are familiar with
because the criteria and process used to the Clean Water Act. They also noted this practice. While the Part 158 Data
develop these data might affect the that residues from agricultural uses of Requirements Rules and registration
reliability of this information. pesticides, e.g., rice pesticides and review decisions are related, they are

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45728 Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Rules and Regulations

not inextricably linked. The revisions to noted in the comment, some pesticides suggested that EPA should re-evaluate
part 158 have benefits but they are not will still be undergoing reregistration the impacts on small business and
a condition precedent to making when the registration review program reduce economic burden on them.
registration review decisions. begins. The Agency recognizes that, to EPA believes it has accurately
The part 158 updates may include avoid confusion during the transition characterized the impacts of the
provisions to codify current practices. between the reregistration and registration review procedures on the
The purpose of the part 158 rule is to registration review programs, it must regulated community, including small
capture with clarity and transparency clearly communicate whether action on businesses. The procedures in this rule
changes in data requirements or an existing pesticide is taken under establish what EPA will do to review a
application of data requirements that reregistration (FIFRA section 4) or pesticide registration. They do not
the Agency has made on a case-by-case registration review under FIFRA section obligate a registrant to take any action.
document since it published its data 3(g). As part of the rulemaking process,
requirements in 1984. This good- EPA is required to estimate the
government goal will amplify C. Unresolved Problems from economic impacts, including effects on
understanding and further enhance Reregistration Will Affect the Agency’s small business, that occur as a
consistency. However, the registration Capacity to Conduct Registration consequence of the rule. Because costs
review program can operate effectively, Review resulting from existing reporting or
as the registration, reregistration, and Industry commented that EPA should recordkeeping requirements or costs
tolerance reassessment programs have, not implement registration review of from other Agency programs are not
in the absence of these enhancements. end-use products until it fixes the imposed by this rule, these costs are not
Final promulgation of the part 158 rules problems with the review of end-use included in the Agency’s assessment of
will simply improve on that sound products in reregistration. The review the impacts of this rule.
foundation. processes in registration review and The regulations do not impose new
Science will continue to evolve even reregistration are likely to be similar and data requirements. They establish the
after the Agency has completed the registration review might duplicate the process by which EPA will decide if
current revision of the data effort of reregistration, especially when additional data are necessary to
requirements in 40 CFR part 158. The a product may undergo product-specific determine whether a pesticide
Agency expects that it will change its review several times (e.g., a product that continues to meet FIFRA standards.
data requirements to reflect this new contains two or more active ingredients That is, data generation costs are only
knowledge. Because one of the goals of may belong in two or more registration indirectly a result of registration review
registration review is to incorporate review cases). The commenters are procedures. It is important to realize
evolving science, the Agency fully concerned that if EPA does not achieve that the per-company costs of $750,000
expects that it might apply new and efficiencies in the review of end-use are primarily the cost of data generation;
different risk assessment tools to products, the 15–year review will that is, they are not a direct cost
pesticides reviewed later in the 15–year extend to 40 years. imposed by this rule.
cycle than it used when it reviewed EPA expects reregistration to satisfy The Agency has determined that this
pesticides early in the 15–year cycle. most product-specific data requirements rule will not have a significant adverse
The Agency appreciates the and achieve many label improvements impact on a substantial number of small
commenter’s concern about market for end-use products. Although the businesses. Nonetheless, the Agency
barriers that might arise if the Agency Agency does not expect it will routinely recognizes that, from the perspective of
uses different risk assessment tools require product-specific data during a small business whose product is
when reviewing pesticides later in the registration review, it expects that undergoing registration review, the costs
15–cycle than it used earlier in the registration review will be an important of data generation in registration review
cycle. Market barriers can be reduced if vehicle for the continuing update of could be significant. Accordingly, the
similar pesticides are reviewed at the labels. The Agency agrees that the Agency is willing to work on a case-by-
same time. This is one of the benefits of review of end-use product labels could case basis with a small business for
the Agency’s plan to group chemically benefit from process improvements. The whom the requirements for data
related cases for review. Agency believes that registrants and generation in registration review are
other stakeholders can help develop burdensome. Data Call-In notices issued
B. Transition from Reregistration to under FIFRA section 3(c)(2)(B) allow a
Registration Review approaches to make this process more
efficient. registrant to request a data waiver that
Industry comments asserted that EPA is based on economic factors. In lieu of
must clarify when the registration IX. Program Costs a new study, the Agency is generally
review program will begin. EPA should willing to consider whether substitute
A. Impacts on Small Businesses
address how it will handle the work of data or bridging data would be
registration actions, reregistration Registrants commented that EPA has adequate. If a new study is required, the
actions, and other mandated regulatory not accurately characterized the effects Agency may consider time extensions so
actions before it commits to initiating of registration review on small business. that a registrant can spread the costs of
the registration review program. EPA They suggested that per-company costs data generation over a longer period of
should clarify the transition process of $750,000 and 2% gross sales are not time. The Agency has made these
between the reregistration and insignificant even for large entities and options available to small businesses in
registration review programs. will have a direct adverse effect on the registration and reregistration
The Agency has announced that the small businesses. They believe that the programs and expects to continue to
registration review program officially cost projections are misleading because make them available for registration
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begins when these regulations go into they do not include all costs incurred by review.
effect. The Agency’s first actions under a registrant such as existing reporting,
the new program will be to issue recordkeeping, and financial burdens B. Cost of Product-Specific Data
schedules and to begin to open imposed by the Agency’s many other Industry comments asserted that the
registration review case dockets. As on-going programs. Commenters economic assessment was incomplete

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because it did not include the costs of X. Technical Changes to the Rule to eliminate any possible confusion as
generating product-specific data, in In addition to the changes made in to whether docketing procedures in part
particular, the costs of repeating efficacy response to comments, the final rule 155 subpart B apply to registration
tests for public health pesticides. At reflects that the Agency made the review activities. Subpart B describes
public meetings on the proposed rule, following technical changes to what was docketing and public participation
the Agency said that it would require proposed: procedures for the registration standard
new product efficacy tests. 1. In § 155.42(d), the Agency added program that the Agency conducted
clarifying phrases (indicated in italics) before it began the reregistration process
These comments accurately describe
to the second and third sentences, as mandated in the 1988 amendments to
the scope of the feasibility study. The
follows: ‘‘In general, the baseline date FIFRA. The Agency will eventually
purpose of the feasibility study was to issue a housekeeping rule to delete this
test the validity of the registration will be the date of initial registration of
the oldest product in the case or the subpart.
review decision paradigm and to 5. In § 155.52, the Agency is making
develop data for estimating the costs of date of reregistration, whichever is later.
The date of reregistration is the date on editorial changes for clarity, as follows:
the program. The Agency did not review • Substitute ‘‘other persons’’ for
individual product registrations in the which the Registration Eligibility
Decision or Interim Reregistration ‘‘public interest groups’’ in the third
feasibility study to determine whether sentence so that it reads, ‘‘The Agency
new product-specific data, including Eligibility Decision was signed,
whichever date the Agency determines may consult with registrants, pesticide
efficacy data, would be required because users, or other persons during a
to be more appropriate based on the
the Agency believes that, to a great pesticide’s registration review . . .’’
comprehensiveness of the review.’’
degree, these product-specific data
2. In § 155.44, EPA is deleting the • Add the phrase ‘‘Minutes of’’ to the
requirements have been satisfied sentence, ‘‘As indicated in § 155.40, the paragraph heading of § 155.52(a) so that
through the registration and Agency may change the schedule of a it reads, ‘‘Minutes of meetings with
reregistration programs and such data pesticide’s registration review if persons outside of government.’’
would generally not be needed to circumstances warrant,’’ because it is 6. In § 155.53, the Agency is making
support a pesticide’s registration review. not a correct reference. several editorial changes for clarity, as
During the registration review of a 3. In § 155.48, EPA is deleting the follows:
public health pesticide, the Agency phrase ‘‘before, during or after a • Add the preposition ‘‘of’’ to the
would determine whether to continue to registration review’’ because it is section heading of § 155.53 so that it
redundant. reads, ‘‘Conduct of a pesticide’s
base the product’s registration on
4. The Agency is modifying § 155.50 registration review.’’
existing product efficacy data. The
as follows: • In the first sentence of this section,
Agency may ask for new product
• In the first sentence add the phrase replace the reference to ‘‘§ 155.51,’’
efficacy data if the product’s which doesn’t exist, with ‘‘§ 155.50(a),
composition has changed so that ‘‘except for cases covered under
§ 155.46.’’ The sentence now reads, (b), and (c).’’
existing data no longer support the • In the first sentence of
current composition of the product, or ‘‘The Agency will initiate a pesticide’s
registration review by establishing a § 155.53(c)(1), replace the phrase ‘‘ask
the test method is no longer valid, or for’’ with the verb ‘‘request.’’
there is information suggesting that the docket for each registration review case,
except for cases covered under § 155.46, 7. In § 155.58, the Agency is making
formulation might not be efficacious as an editorial change in paragraph (b)(3)
claimed. The Agency did not review and opening it for public review.’’
• Change the paragraph heading of by deleting the phrase ‘‘precede,
product chemistry data in the feasibility accompany or follow’’ from the second
§ 155.50(a) to ‘‘Contents of the
study to make case-by-case sentence and replacing it with the
registration review case docket.’’ The
determinations whether existing phrase ‘‘may be issued in conjunction
Agency has deleted the first sentence of
product efficacy tests are appropriate for with.’’
this paragraph and modified the last
the composition of the product. The
sentence to read, ‘‘The Agency will XI. FIFRA Review Requirements
Agency has not revised antimicrobial
consider including, but not limited to,
efficacy test methods, so, for purposes of the following information: . . .’’ The In accordance with FIFRA section
the feasibility study, the existing Agency is making these changes to make 25(a) and 25(d), this rule was submitted
efficacy tests were considered to be clear that this paragraph describes the to the FIFRA Science Advisory Panel
valid. (If the Agency had information contents of the initial docket. (SAP), the Secretary of Agriculture
suggesting that a product in the • Change § 155.50(c) by adding (USDA), and appropriate Congressional
feasibility study was not efficacious as ‘‘during the comment period’’ to the Committees.
claimed, the Agency would not wait paragraph heading and by changing the XII. Statutory and Executive Order
until registration review to ask for new first sentence in paragraph (c)(1) to read Reviews
efficacy data. The Agency would have as follows: ‘‘In order to ensure that the
issued a DCI or initiated other action Agency will consider data or A. Executive Order 12866
under FIFRA, as appropriate.) The information in the conduct of a Pursuant to Executive Order 12866,
Agency believes that the costs of registration review, interested persons entitled Regulatory Planning and
replacing product efficacy data for a few must submit the data or information Review (58 FR 51735, October 4, 1993),
products in a registration review case during the comment period established the Office of Management and Budget
will be much lower than the costs of in the notice described in paragraph (b) (OMB) has designated this rule as a
generating new generic data to support of this section.’’ These changes are for ‘‘significant regulatory action’’ under
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the active ingredient(s) in a registration clarity. section 3(f) of the Executive Order
review case. In any case, any costs for • Add paragraph § 155.50(d) as because it may raise novel legal or
generating new product-specific efficacy follows, ‘‘For the purposes of this policy issues arising out of legal
data would not be a direct cost imposed subpart, the provisions of subpart B do mandates, the President’s priorities, or
by this procedural regulation. not apply.’’ EPA is making this change the principles set forth in the Executive

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45730 Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Rules and Regulations

Order. This action was therefore for potential data generation activities reflects the burden estimates in the
submitted to OMB for review under this accounting for approximately 70% of Economic Analysis.
Executive Order, and any changes to these costs. The Agency estimates about Under the PRA, ‘‘burden’’ means the
this document made at the suggestion of 68 companies will be impacted each total time, effort, or financial resources
OMB have been documented in the year; thus, per-company costs for the expended by persons to generate,
public docket for this rulemaking. entire registration review process are maintain, retain, or disclose or provide
EPA has prepared an economic likely to average less than $750,000 each information to or for a Federal agency.
analysis of the potential impacts of the year, even though some companies may This includes the time needed to review
registration review procedures. In have multiple chemicals under review instructions; develop, acquire, install,
addition to analyzing the requirements during the year. Out of the universe of and utilize technology and systems for
contained in this rule, the Agency 2,000 small businesses estimated to the purposes of collecting, validating,
analyzed other potential actions that hold pesticide registrations, the Agency and verifying information, processing
could occur during a registration review estimates that each year about 30 small and maintaining information, and
using other existing authorities that are businesses that have responsibility for disclosing and providing information;
not changed in this rule. The Agency’s providing data to support the adjust the existing ways to comply with
analysis, therefore, considers the registration of a pesticide would be any previously applicable instructions
potential impact of the registration involved in a registration review. and requirements; train personnel to be
review process, which includes the Assuming the same level of able to respond to a collection of
costs of a registrant’s participation in participation and potential need to information; search data sources;
the public review components of the generate data, the estimated average cost complete and review the collection of
process described in this rule and other of the registration review process is information; and transmit or otherwise
potential requirements imposed by estimated to be less than 2% of the gross disclose the information.
existing authorities such as data sales for small businesses involved in a Under the PRA, an agency may not
generation under FIFRA section registration review. conduct or sponsor, and a person is not
3(c)(2)(B). This analysis is contained in
B. Paperwork Reduction Act (PRA) required to respond to a collection of
a document entitled Economic Analysis
The information collection activities information unless it displays a
of the Procedural Regulations for the
associated with the registration review currently valid OMB control number.
Registration Review of Pesticides. EPA
program are already approved by the The OMB control numbers for EPA’s
placed a copy of this Economic Analysis
in the public docket for this action Office of Management and Budget regulations codified in Chapter 40 of the
when it published the proposed rule. (OMB) under the Paperwork Reduction CFR, after appearing in the preamble of
Comments on the Economic Analysis Act, 44 U.S.C. 3501 et seq. That the final rule, are listed in 40 CFR part
did not warrant revision of this Information Collection Request (ICR) 9, are displayed either by publication in
document and the Agency will rely on document has been assigned EPA ICR the Federal Register or by other
this document to support the final rule. number 0922.07, and OMB control appropriate means, such as on the
The Economic Analysis is briefly number 2070–0057. Although this related collection instrument or form, if
summarized here. action does not impose any new applicable. The display of OMB control
The rule does not require registrants information collection requirements that numbers in certain EPA regulations is
to take specific action as part of the would require additional approval by consolidated in 40 CFR part 9. For the
review of a pesticide registration, OMB, the Agency expects the approved ICR activity contained in this final rule,
however, the Agency’s analysis assumes burden estimate to increase with the full in addition to displaying the applicable
that registrants will engage in their own implementation of the registration OMB control number in this unit, the
evaluation of information provided by review process. A copy of the OMB Agency is amending the table in 40 CFR
the Agency and other stakeholders, and approved ICR has been placed in the 9.1 to list the OMB control number
participate in the public process public docket for this rule, and the assigned to this ICR activity. Due to the
described in this rule. The Agency Agency’s estimated burden increase is technical nature of the table, EPA finds
estimates such industry costs to be presented in the economic analysis that that further notice and comment about
around $1.2 million annually. has been prepared for this rule. amending the table is unnecessary. As a
The Agency recognizes that under As detailed in the Economic Analysis result, EPA finds that there is ‘‘good
other existing authorities a registrant prepared for this rule, the annual cause’’ under section 553(b)(B) of the
may also need to submit data that they respondent burden for information Administrative Procedures Act (APA), 5
have or generate data as necessary to collection activities associated with the U.S.C. 553(b)(B), to amend this table
support the registration. As such, the registration review program is estimated without further notice and comment.
analysis also considers the potential to average 120,000 hours, with an
C. Regulatory Flexibility Act
cost to industry from other anticipated estimated total annual respondent cost
activities under existing authorities that of $10,800,000. The July 13, 2005, Pursuant to section 605(b) of the
may occur during the registration proposed rule invited comments on the Regulatory Flexibility Act (RFA), 5
review process, although such activities Agency’s need for this information, the U.S.C. 601 et seq., the Agency hereby
are not requirements in this rulemaking. accuracy of the provided burden certifies that this rule will not have a
These activities include potential data estimates, and any suggested methods significant adverse economic impact on
submission or generation activities for minimizing respondent burden, a substantial number of small entities.
related to DCIs, including the including the use of automated This rule defines the procedures that
paperwork burden, and other activities collection techniques. No comments EPA will follow to implement the
that might occur under other existing were received. Therefore, the Agency statutory registration review provision.
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authorities. has submitted an information correction It does not impose any new
Considering these other potential worksheet request to OMB to amend its requirements on the regulated
activities, the analysis shows an existing ICR covering the information community. As such, this rule does not
estimated total annual cost to industry collection activities associated with the have direct adverse impacts on small
of about $50 million, with the estimates registration review program so that it businesses, small non-profit

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Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Rules and Regulations 45731

organizations, or small local F. Executive Order 13175 Executive Order 12898, entitled Federal
governments. As required by Executive Order Actions to Address Environmental
For purposes of assessing the impacts 13175, entitled Consultation and Justice in Minority Populations and
of this rule on small entities, small Coordination with Indian Tribal Low-Income Populations (59 FR 7629,
entity is defined as: (1) A small business Governments (65 FR 67249, November February 16, 1994), the Agency does not
as defined by the Small Business 6, 2000), EPA has determined that this need to consider environmental justice-
Administration’s (SBA) regulations at 13 rule does not have tribal implications related issues.
CFR 121.201, which for the pesticide because it will not have any affect on XIII. Congressional Review Act
industry consists of businesses with tribal governments, on the relationship
fewer than 500 to 1,000 employees between the Federal government and The Congressional Review Act, 5
(range is based on NAICS sector the Indian tribes, or on the distribution U.S.C. 801 et seq., generally provides
variations); (2) a small governmental of power and responsibilities between that before a rule may take effect, the
jurisdiction that is a government of a the Federal government and Indian Agency promulgating the rule must
city, county, town, school district or tribes, as specified in the Order. Thus, submit a rule report, which includes a
special district with a population of less Executive Order 13175 does not apply copy of the rule, to each House of the
than 50,000; and (3) a small to this rule. Congress and the Comptroller General of
organization that is any not-for-profit the United States. EPA will submit a
G. Executive Order 13211
enterprise which is independently report containing this rule and other
This rule is not subject to Executive required information to the U.S. Senate,
owned and operated and is not
Order 13211, entitled Actions the U.S. House of Representatives, and
dominant in its field. The regulated
Concerning Regulations that the Comptroller General of the United
community does not include any small Significantly Affect Energy Supply,
not-for-profit organizations. Small local States prior to publication of the rule in
Disribution, or Use (66 FR 28355, May the Federal Register. This rule is not a
government organizations, such as 22, 2001) because it is not designated as
counties, may register a pesticide under ‘‘major rule’’ as defined by 5 U.S.C.
an ‘‘economically significant’’ 804(2).
FIFRA section 24(c). However, such regulatory action as defined by
registrants generally do not Executive Order 12866 (see Unit List of Subjects in 40 CFR Part 9
manufacture, distribute or sell XIII.A.), nor is it likely to have any
pesticides and generally would not be Environmental protection, Reporting
significant adverse effect on the supply, and recordkeeping requirements.
responsible for generating data to distribution, or use of energy.
support the registration of pesticides.
Accordingly, the Agency finds that this H. Executive Order 13045 List of Subjects in 40 CFR Part 155
rule does not have a direct adverse Executive Order 13045, entitled Environmental protection,
effect on small local governments. Protection of Children from Administrative practice and procedure,
Environmental Health Risks and Safety Pesticides and pests.
D. Unfunded Mandates Reform Act
Risks (62 FR 19885, April 23, 1997) does
Under Title II of the Unfunded not apply to this rule because this action Dated: August 1, 2006.
Mandates Reform Act of 1995 (UMRA) is not designated as an ‘‘economically Stephen L. Johnson,
(Public Law 104–4), EPA has significant’’ regulatory action as defined Administrator.
determined that this action does not by Executive Order 12866, (see Unit
contain a Federal mandate that may XIII.A.), nor does it establish an ■ Therefore, 40 CFR chapter I is
result in expenditures of $100 million or environmental standard, or otherwise amended as follows:
more for State, local, and tribal have a disproportionate effect on ■ 1. Part 9 is amended as follows:
governments, in the aggregate, or the children.
private sector in any one year. As PART 9—[AMENDED]
I. National Technology Transfer and
described in Unit XIII.A., this rule is not Advancement Act
expected to result in such expenditures. ■ a. The authority citation for part 9
Section 12(d) of the National continues to read as follows:
In addition, this action will not impact
Technology Transfer and Advancement Authority: 7 U.S.C. 135 et seq., 136–136y;
small governments, or local or tribal
Act of 1995 ((NTTAA), 15 U.S.C. 272 15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671,
governments. Accordingly, this rule is
note) directs EPA to use voluntary 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
not subject to the requirements of
consensus standards in its regulatory U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318,
sections 202, 203, 204, and 205 of
activities unless to do so would be 1321, 1326, 1330, 1342, 1344, 1345 (d) and
UMRA. (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
inconsistent with applicable law or
E. Executive Order 13132 impractical. Voluntary consensus 1971–1975 Comp. p. 973; 42 U.S.C. 241,
standards are technical standards (e.g., 242b, 243, 246, 300f, 300g, 300g–1, 300g–2,
Pursuant to Executive Order 13132, 300g–3, 300g–4, 300g–5, 300g–6, 300j–1,
materials specifications, test methods,
entitled Federalism (64 FR 43255, 300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq.,
sampling procedures) that are 6901–6992k, 7401–7671q, 7542, 9601–9657,
August 10, 1999), EPA has determined developed or adopted by voluntary 11023, 11048.
that this rule does not have ‘‘federalism consensus standards bodies. This rule
implications,’’ because it will not have does not impose any technical standards ■ b. In § 9.1, the table is amended by
substantial direct effects on the states, that would require EPA to consider any revising the existing heading for
on the relationship between the national voluntary consensus standards. ‘‘Registration Standards’’; removing the
government and the states, or on the entry under that heading; and adding a
J. Executive Order 12898
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distribution of power and new entry to read as follows:


responsibilities among the various This rule does not have an adverse
levels of government, as specified in the impact on the environmental and health § 9.1 OMB approvals under the Paperwork
Order. Thus, Executive Order 13132 conditions in low-income and minority Reduction Act.
does not apply to this rule. communities. Therefore, under * * * * *

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45732 Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Rules and Regulations

40 CFR citation OMB control no. (2) If a product fails to satisfy the information may suggest that active
FIFRA standard for registration, the ingredients in a registration review case
* * * * * product’s registration may be subject to are not as similar as previously believed
. cancellation or other remedies under and that they belong in two or more
FIFRA. separate registration review cases.
Registration Standards and Registration
(b) Applicability. This subpart applies (3) Move an ingredient from one
Review
to every pesticide product registered registration review case to another. For
* * * * * under FIFRA section 3 as well as all example, new data or information might
Part 155 .......................... 2070–0057 pesticide products registered under suggest that an ingredient should not be
FIFRA section 24(c). It does not apply grouped with the other ingredients in
* * * * * to products whose sale or distribution is the registration review case and that it
■ 2. Part 155 is amended as follows: authorized under FIFRA section 5 or belongs in a different registration review
section 18. case.
PART 155–REGISTRATION (c) Limitations. (1) At any time, the (4) Merge two or more registration
STANDARDS AND REGISTRATION Agency may undertake any other review review cases into a single registration
REVIEW of a pesticide under FIFRA, irrespective review case. For example, new data or
■ a. The authority citation for part 155 of the pesticide’s past, ongoing, information might suggest that the
continues to read as follows: scheduled, or not yet scheduled active ingredients in two or more
registration review. registration review cases should be
Authority: 7 U.S.C. 1361.
(2) When the Agency determines that grouped together for registration review.
■ b. By revising the heading of part 155 new data or information are necessary (5) Delete an active ingredient from a
to read as set forth above. for a pesticide’s registration review, it registration review case. For example,
■ c. By adding a new subpart C to read will require such data under FIFRA the Agency will remove the ingredient
as follows: section 3(c)(2)(B). from the case if the registrations of all
Subpart C—Registration Review § 155.42 Registration review cases. products containing an active ingredient
Procedures in a registration review case are
(a) Establishing registration review
canceled.
Sec. cases. A registration review case will be
(c) Closing a registration review case.
155.40 General. composed of one or more active
The Agency will close a registration
155.42 Registration review cases. ingredients and all the products
review case if all products in the case
155.44 Establish schedules for registration containing such ingredient(s). The
review. are canceled.
Agency may group related active
155.46 Deciding that a registration review is ingredients into a registration review (d) Establishing a baseline date for a
complete and additional review is not case when the active ingredients are so registration review case. For the purpose
needed.
closely related in chemical structure of scheduling registration reviews, the
155.48 Data Call-In. Agency will establish a baseline date for
155.50 Initiate a pesticide’s registration and toxicological profile as to allow
common use of some or all required each registration review case. In general,
review.
data for hazard assessment. the baseline date will be the date of
155.52 Stakeholder engagement.
155.53 Conduct of a pesticide’s registration (1) Existing pesticides. The Agency initial registration of the oldest pesticide
review. will assign each pesticide registered on product in the case or the date of
155.56 Interim registration review decision. or before the effective date of this reregistration, whichever is later. For
155.57 Registration review decision. regulation to a registration review case. the purpose of these procedures, the
155.58 Procedures for issuing a decision on date of reregistration is the date on
a registration review case.
(2) New pesticides. The Agency will
assign each pesticide registered after the which the Reregistration Eligibility
effective date of this regulation to an Decision or Interim Reregistration
Subpart C—Registration Review
existing registration review case or to a Decision was signed, whichever date the
Procedures
new registration review case. Agency determines to be more
§ 155.40 General. (3) A pesticide product that contains appropriate based on the
(a) Purpose. These regulations multiple active ingredients will belong comprehensiveness of the review.
establish procedures for the registration to the registration review cases for each (1) The Agency generally will not
review program required in FIFRA 3(g). of its active ingredients. change the baseline date for a
Registration review is the periodic (b) Modifying registration review registration review case when it
review of a pesticide’s registration to cases. New data or information may modifies a case by adding or deleting
ensure that each pesticide registration suggest that a registration review case ingredients or products.
continues to satisfy the FIFRA standard should be modified. The Agency may (2) When the Agency splits a
for registration. The goal of the modify a registration review case in the registration review case into two or
registration review procedures is review following ways: more cases, the new case(s) generally
of each pesticide’s registration every 15 (1) Add a new active ingredient to a will have the baseline date of the
years. registration review case. The Agency original registration review case.
(1) Among other things, FIFRA may determine that a new active (3) When the Agency merges two or
requires that a pesticide generally will ingredient is chemically and more registration review cases into a
not cause unreasonable adverse effects toxicologically similar to active single case, the Agency generally will
on the environment. Registration review ingredients in an existing registration use the earliest baseline date as the
is intended to ensure that each review case and should be grouped with baseline date for the new case.
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pesticide’s registration is based on the ingredients in the existing (e) Announcing registration review
current scientific and other knowledge registration review case. cases and baseline dates. The Agency
regarding the pesticide, including its (2) Split a registration review case will maintain a list of registration
effects on human health and the into two or more registration review review cases, including baseline dates,
environment. cases. For example, new data or on its website.

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§ 155.44 Establish schedules for information and issues that the Agency a previous review. However, submitters
registration review. may consider in the course of the must explain why they believe the
The Agency will develop schedules registration review. The Agency may Agency should reconsider the data or
for registration review that are generally include information from its files information in the pesticide’s
based on the baseline date of the including, but not limited to, the registration review.
registration review case or on the date following information: (d) For the purposes of this subpart,
of the latest registration review of the (1) An overview of registration review the provisions of subpart B do not
registration review case. The Agency case status; apply.
may also take into account other factors, (2) A list of current registrations and
such as achieving process efficiencies registrants, any Federal Register notices § 155.52 Stakeholder engagement.
by reviewing related cases together, regarding pending registration actions, In addition to the public participation
when developing schedules for and current or pending tolerances; opportunities described in § 155.50 and
registration review. The Agency will (3) Risk assessment documents; § 155.53(c), the Agency may meet with
maintain schedules for the current year (4) Bibliographies concerning current stakeholders regarding a forthcoming or
and at least two subsequent years on its registrations; ongoing registration review. For
website. (5) Summaries of incident data; and example, before conducting a pesticide’s
(6) Any other pertinent data or registration review, the Agency may
§ 155.46 Deciding that a registration information. consult with registrants or pesticide
review is complete and additional review is (b) Public review of the registration
not needed.
users regarding the use and usage of the
review case docket. The Agency will pesticide. The Agency may consult with
The Agency may determine that there publish a notice in the Federal Register registrants, pesticide users, or other
is no need to reconsider a previous announcing the availability for public persons during a pesticide’s registration
decision that a pesticide satisfies the review of the information described in review with regard to developing risk
standard of registration in FIFRA. In paragraph (a) of this section and management options for a pesticide. The
such cases, instead of establishing a establishing a comment period of at Agency may informally consult with
pesticide registration review case docket least 60 days. During this comment officials of Federal, State or Tribal
as described in § 155.50, the Agency period, interested persons may identify agencies regarding a forthcoming or
may propose that, based on its any additional information they believe ongoing registration review.
determination that a pesticide meets the the Agency should consider in the (a) Minutes of meetings with persons
FIFRA standard for registration, no course of the registration review. outside of government. The Agency will
further review will be necessary. In such (c) Submission of data and other place in the docket minutes of meetings
circumstances, the Agency will publish information during the comment period. with persons outside of government
a notice in the Federal Register The Agency may identify, either in the where the primary purpose of the
announcing the availability of the notice published under paragraph (b) of meeting is to discuss a forthcoming or
proposed decision and provide a this section, or at any other time, data ongoing registration review. The Agency
comment period of at least 60 calendar or information that it does not have but
days. The Agency will publish a notice will place minutes of such meetings in
which may be useful, if available, for the docket when it takes action under
in the Federal Register announcing the consideration in the registration review.
availability of a final version of the § 155.58. At its discretion, the Agency
Any person may submit data or may place minutes of such meetings in
decision, an explanation of any changes information in response to such
to the proposed decision and its the docket sooner.
identification. In order to be considered (b) Exchange of documents or other
response to any comments. The date of during a pesticide’s registration review,
the final notice of availability would be written material. In the course of a
the submitted data or information must meeting with a person outside of
used as the date of the latest registration meet the requirements listed below.
review for the purpose of scheduling government, the Agency or that person
(1) In order to ensure that the Agency may provide the other with a copy of a
subsequent registration reviews. will consider data or information in the document or other written material that
§ 155.48 Data Call-In. conduct of a registration review, has not yet been released to the public.
The Agency may issue a Data Call-In interested persons must submit the data The Agency will place a copy of any
notice under FIFRA section 3(c)(2)(B) at or information during the comment such document or other written material
any time if the Agency believes that the period established in the notice in the docket along with the minutes of
data are needed to conduct the described in paragraph (b) of this the meeting where the materials were
registration review. The provisions in section. The Agency may, at its exchanged.
FIFRA section 3(c)(1), (c)(2)(B), and discretion, consider data or information (c) Confidential business information.
(c)(2)(D) apply to the submission, submitted at a later date. The Agency will not place confidential
compensation, and exemption of data (2) The data or information must be business information in the docket.
required to conduct a registration presented in a legible and useable form.
For example, an English translation § 155.53 Conduct of a pesticide’s
review. registration review.
must accompany any material that is not
§ 155.50 Initiate a pesticide’s registration in English and a written transcript must The Agency will review data and
review. accompany any information submitted information described in § 155.50(a), (b),
The Agency will initiate a pesticide’s as an audiographic or videographic and (c) or submitted in response to a
registration review by establishing a record. Written material may be Data Call-In notice that it believes
docket for each registration review case, submitted in paper or electronic form. should be considered in the pesticide’s
except for cases covered under § 155.46, (3) Submitters must clearly identify registration review.
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and opening it for public review. the source of any submitted data or (a) Assess changes since a pesticide’s
(a) Contents of the registration review information. last review. The Agency will assess any
case docket. The Agency will place in (4) Submitters may request the changes that may have occurred since
this docket information that will assist Agency to reconsider data or the Agency’s last registration decision in
the public in understanding the types of information that the Agency rejected in order to determine the significance of

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45734 Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Rules and Regulations

such changes and whether the pesticide risk assessment for a pesticide if a new pesticide meets, or does not meet, the
still satisfies the FIFRA standard for risk assessment has been conducted. standard for registration in FIFRA.
registration. The Agency will consider The Agency will publish a notice in the
whether to conduct a new risk Federal Register announcing the § 155.58 Procedures for issuing a decision
on a registration review case.
assessment to take into account, among availability of the draft risk assessment
other things, any changes in statutes or and provide a comment period of at (a) The Agency will publish a notice
regulations, policy, risk assessment least 30 calendar days. The Agency will in the Federal Register announcing the
procedures or methods, or data publish a notice in the Federal Register availability of a proposed registration
requirements. The Agency will consider announcing the availability of a revised review decision or a proposed interim
whether any new data or information on risk assessment, an explanation of any registration review decision. At that
the pesticide, including any data or changes to the proposed document, and time, the Agency will place in the
information submitted under § 155.50 or its response to comments. If the revised pesticide’s registration review docket
in response to a Data Call-In notice, risk assessment indicates risks of the Agency’s proposed decision and the
warrant conducting a new risk concern, the Agency may, in the notice bases for the decision. There will be a
assessment or a new risk/benefit announcing the availability of the comment period of at least 60 calendar
assessment. The Agency will also revised risk assessment, provide a days on the proposed decision.
consider whether any new data or comment period of at least 30 calendar (b) In its proposed decision, the
information regarding an individual days for the public to submit Agency will, among other things:
pesticide product, including any data or suggestions for mitigating the risk (1) State its proposed findings with
information submitted under § 155.50 or identified in the revised risk respect to the FIFRA standard for
in response to a Data Call-In notice, assessment. registration and describe the basis for
such as data or information about an (1) The Agency might not request such proposed findings.
inert ingredient in the pesticide product comments on a draft risk assessment in (2) Identify proposed risk mitigation
or other information or data relating to cases where the Agency’s initial measures or other remedies as needed
the composition, labeling or use of the screening of a pesticide indicates that it and describe the basis for such proposed
pesticide product, warrant additional has low use/usage, affects few if any requirements.
review of a pesticide product’s stakeholders or members of the public, (3) State whether it believes that
registration. poses low risk, and/or requires little or additional data are needed and, if so,
(b) Conduct new assessments as no risk mitigation. In such cases, the describe what is needed. A FIFRA
needed. (1) Active ingredient(s) in the Agency will make a draft risk 3(c)(2)(B) notice requiring such data
registration review case. If the Agency assessment available for public review may be issued in conjunction with a
finds that a new assessment of the and comment when it issues a proposed proposed or final decision on the
pesticide is needed, it will determine decision on the registration review case. registration review case or a proposed or
whether it can base the new assessment (2) If the Agency finds that it is not
final interim decision on a registration
on available data or information, necessary to conduct a new risk
review case.
including data or information submitted assessment, it will issue a proposed
decision on the registration review case (4) Specify proposed labeling changes;
under § 155.50 or in response to a Data and
Call-In notice. If sufficient data or as described in § 155.58.
(5) Identify deadlines that it intends
information are available, the Agency § 155.56 Interim registration review to set for completing any required
will conduct the new risk assessment or decision. actions.
risk/benefit assessment. If the Agency The Agency may issue, when it (c) After considering any comments
determines that additional data or determines it to be appropriate, an on the proposed decision, the Agency
information are needed to conduct the interim registration review decision will issue a registration review decision
review, the Agency will issue a Data before completing a registration review. or interim registration review decision.
Call-In notice under FIFRA section Among other things, the interim This decision will include an
3(c)(2)(B). registration review decision may require explanation of any changes to the
(2) Individual product registrations. If new risk mitigation measures, impose proposed decision and the Agency’s
the Agency finds that additional review interim risk mitigation measures, response to significant comments. The
of an individual product’s registration is identify data or information required to Agency will publish a notice in the
needed, it will review the pesticide complete the review, and include Federal Register announcing the
product label, confidential statement of schedules for submitting the required availability of a registration review
formula, product-specific data, or other data, conducting the new risk decision or interim registration review
pertinent data or information, as assessment and completing the decision. The registration review case
appropriate, to determine whether the registration review. A FIFRA 3(c)(2)(B) docket will remain open until all
registration of the individual product notice requiring the needed data or actions required in the final decision on
meets the FIFRA standard for information may precede, accompany, the registration review case have been
registration. If the Agency determines or follow issuance of the interim completed.
that additional data or information are registration review decision. The (d) If the registrant fails to take the
needed to conduct the review, the Agency will follow procedures in action required in a registration review
Agency will issue a Data Call-In notice § 155.58 when issuing an interim decision or interim registration review
under FIFRA section 3(c)(2)(B). registration review decision. decision, the Agency may take
(c) Public participation during a
§ 155.57 Registration review decision. appropriate action under FIFRA.
pesticide’s registration review. The
Agency will generally make available A registration review decision is the [FR Doc. E6–12904 Filed 8–8–06; 8:45 am]
jlentini on PROD1PC65 with RULES3

for public review and comment a draft Agency’s determination whether a BILLING CODE 6560–50–S

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