Attachment C
40 CFR Parts 9 and 155
Pesticides; Procedural Regulations for Registration Review;
Final Rule, August 9, 2006 (71 FR 45720)
Attachment C
40 CFR Parts 9 and 155
Pesticides; Procedural Regulations for Registration Review;
Final Rule, August 9, 2006 (71 FR 45720)
[Federal Register: August 9, 2006 (Volume 71, Number 153)]
[Rules and Regulations]
[Page 45719-45734]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09au06-30]
[[Page 45719]]
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Part IV
Environmental Protection Agency
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40 CFR Parts 9 and 155
Pesticides; Procedural Regulations for Registration Review; Final Rule
[[Page 45720]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 155
[EPA-HQ-OPP-2004-0404; FRL-8080-4]
RIN 2070-AD29
Pesticides; Procedural Regulations for Registration Review
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes procedures for conducting the pesticide
registration review program mandated by the Federal Insecticide,
Fungicide, and Rodenticide Act. Under this rule, EPA will review
existing pesticide registrations to determine whether they continue to
meet the statutory standard for registration. The registration review
program will begin in the fall of 2006. This rule provides for the
establishment of pesticide cases for review, the scheduling of reviews,
the initiation, completion and documentation of reviews, and associated
public participation procedures. The registration review program
established by this regulation is intended to ensure that all pesticide
registrations are systematically reviewed in a manner that is based on
sound science and provides for public participation, transparency and
efficiency to protect public health and the environment. In addition,
in order to display the OMB control number for the information
collection requirements contained in this final rule, EPA is amending
the table of OMB approval numbers for EPA regulations.
DATES: This final rule is effective on October 10, 2006.
ADDRESSES: EPA has established a docket for this action under Docket
identification (ID) number EPA-HQ-OPP-2004-0404. All documents in the
docket are listed in the docket index at http://www.regulations.gov.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the Office
of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Drive, Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Vivian Prunier, Field and External
Affairs Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: 703-308-9341; fax number: 703-305-5884; e-mail
address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you hold
pesticide registrations. Pesticide users or other persons interested in
the regulation of the sale, distribution or use of pesticides may also
be interested in this procedural regulation. Potentially affected
entities may include, but are not limited to:
Producers of pesticide products (NAICS code 32532).
Producers of antifoulant paints (NAICS code 32551).
Producers of antimicrobial pesticides (NAICS code 32561).
Producers of nitrogen stabilizer products (NAICS code
32531).
Producers of wood preservatives (NAICS code 32519).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Sec. 155.40 of the
rule. If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using http://www.regulations.gov to access this
document and other related information in the electronic docket, you
may access this Federal Register document electronically through the
EPA Internet under the ``Federal Register'' listings at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.epa.gov/fedrgstr/
.
II. Overview of this Document
In this document, EPA presents its response to comments on the
proposed rule to establish procedural regulations for the registration
review of pesticides. In response to comments, EPA is modifying some
aspects of the rule relating to procedures for public participation in
the registration review process. The differences between the proposed
rule and the final rule are described in Units VI. and X.
In this document, the Agency describes:
Statutory authority.
History of this rulemaking.
Response to comments on the rule.
Response to comments on the operation and implementation
of the program.
Results of reviews required by statutes or executive
orders.
Changes to the rule.
Procedural regulations for the registration review of
pesticides.
III. Authority
A. EPA's Authority to License Pesticides
FIFRA section 3(a) generally requires a person to register a
pesticide product with the EPA before the pesticide product may be
lawfully distributed or sold in the U.S. A pesticide registration is a
license that allows a pesticide product to be distributed or sold for
specific uses under specified terms and conditions. A pesticide product
may be registered or remain registered only if it meets the statutory
standard for registration given in FIFRA section 3(c)(5), as follows:
(A) its composition is such as to warrant the proposed claims
for it;
(B) its labeling and other material required to be submitted
comply with the requirements of this Act;
(C) it will perform its intended function without unreasonable
adverse effects on the environment; and
(D) when used in accordance with widespread and commonly
recognized practice it will not generally cause unreasonable adverse
effects on the environment.
FIFRA 2(bb) defines ``unreasonable adverse effects on the
environment'' as
(1) any unreasonable risk to man or the environment, taking into
account the economic, social, and environmental costs and benefits
of the use of any pesticide, or (2) a human dietary risk from
residues that result from a use of a pesticide in or on any food
inconsistent with the standard under section 408 of the Federal
Food, Drug, and Cosmetic Act.
The burden to demonstrate that a pesticide product satisfies the
criteria for registration is at all times on the
[[Page 45721]]
proponents of initial or continued registration. (Industrial Union
Dept. v. American Petroleum Institute, 448 U.S. 607, 653 n. 61 (1980);
Environmental Defense Fund v. Environmental Protection Agency, 510 F.2d
1292, 1297, 1302 (D.C. Cir. 1975).
B. EPA's Authority for Registration Review
The Food Quality Protection Act (FQPA) of 1996 amended FIFRA to
add, among other things, section 3(g), ``REGISTRATION REVIEW,'' as
follows:
(1)(A) GENERAL RULE. - The registrations of pesticides are to be
periodically reviewed. The Administrator shall by regulation
establish a procedure for accomplishing the periodic review of
registrations. The goal of these regulations shall be a review of a
pesticide's registration every 15 years. No registration shall be
canceled as a result of the registration review process unless the
Administrator follows the procedures and substantive requirements of
section 6.
(B) LIMITATION. - Nothing in this subsection shall prohibit the
Administrator from undertaking any other review of a pesticide
pursuant to this Act.
(2)(A) DATA. - The Administrator shall use the authority in
subsection (c)(2)(B) to require the submission of data when such
data are necessary for a registration review.
(B) DATA SUBMISSION, COMPENSATION, AND EXEMPTION. - For purposes
of this subsection, the provisions of subsections (c)(1), (c)(2)(B),
and (c)(2)(D) shall be utilized for and be applicable to any data
required for registration review.
IV. Notice of Proposed Rulemaking
EPA published proposed procedures for the registration review of
pesticides on July 13, 2005 (70 FR 40251) (FRL-7718-4). A copy of the
proposed rule may be found in Docket EPA-HQ-OPP-2004-0404, which can be
accessed electronically at: http://www.regulations.gov. The 90-day
comment period for this proposed rule ended on October 11, 2005.
The preamble to the proposed rule discussed:
Statutory authority and legislative history.
The Agency's goals for the registration review program.
Evaluating approaches to registration review.
Factors considered in designing the registration review
program.
Design options considered for the registration review
program.
Testing the proposed registration review decision process.
Proposed procedures for registration review.
Relationship of registration review to other FIFRA
activities.
Phase-in of the registration review program.
Results of reviews required by statutes and executive
orders.
V. Overview of Comments
EPA received 23 comments on the proposed rule, as follows:
One individual.
Two consultants.
One public interest group.
Four registrants.
One State Pesticide Safety Coordinator.
Three State Lead Agencies for pesticides.
Five California water sanitation agencies.
Six trade associations.
The Agency's analysis of these comments showed that the comments
can be organized into three broad topic areas:
Requests for changes in the procedural regulations. These
comments and the Agency's response are discussed in this preamble.
Operation and implementation of the registration review
program. These comments and the Agency's response are discussed in this
preamble.
Issues concerning the licensing of pesticides in general
are described in the response to comments document that the Agency has
placed in the docket for this rulemaking.
In general, comments on the proposed rule resulted in minimal
revisions in the final rule. Early implementation will continue to be
discussed with the Pesticide Program Dialogue Committee, a stakeholder
advisory committee established under the Federal Advisory Committee
Act. EPA may issue additional guidance on the registration review
program as it gains experience with these procedures.
VI. Comments on the Procedural Regulations
A. Sec. 155.40--General
This section describes the purpose of the regulations in Subpart C-
-Registration Review Procedures and states that the goal of these
procedures is a review of each pesticide's registration every 15 years.
This section also specifies that the regulations apply to pesticides
registered under section 3 or section 24(c) of FIFRA, states that the
Agency may undertake any other review under FIFRA at any time and that
the Agency will use FIFRA section 3(c)(2)(B) to require new data or
information that are necessary for a pesticide's registration review.
1. Authority to establish procedures for registration review. A
trade association questioned EPA's authority to establish the proposed
procedures for registration review. They asserted that in the absence
of specific procedures in FIFRA for the administration of registration
review, EPA must use procedures in FIFRA section 3(c)(8) which
specifies procedures for conducting interim administrative review to
develop a risk-benefit evaluation of a pesticide. Procedures for
implementing FIFRA section 3(c)(8) are described in 40 CFR part 154.
The Agency does not agree with this comment. FIFRA section
3(g)(1)(A), which mandates a periodic review of the registration of
pesticides, requires the Agency to establish procedures for conducting
such reviews. This provision means that, except for limitations
specified in FIFRA section 3(g)(1)(B) and FIFRA 3(g)(2), EPA has the
authority to develop procedures for the conduct of this new program.
Accordingly, EPA is not required to use procedures in FIFRA section
3(c)(8) to conduct the review mandated in FIFRA section 3(g).
2. Registration review of pesticides covered under FIFRA section
25(b). An industry comment asked EPA to assure that products exempted
from FIFRA regulation under section 25(b) of FIFRA are reviewed
adequately, especially with regards to health claims.
Pesticides that are exempt from FIFRA requirements under FIFRA
section 25(b) are identified in 40 CFR 152.20, Exemptions for
pesticides regulated by another Federal agency, and 40 CFR 152.25,
Exemptions for pesticides of a character not requiring FIFRA
regulation. Pesticides covered by FIFRA section 25(b) are not subject
to registration review. However, some products that are exempt under
FIFRA section 25(b) could be affected by actions taken in registration
review. For example, pesticide-treated articles or substances described
in Sec. 152.25(a) could be affected if issues arise during the
registration review of a pesticide used to treat an article or
substance. If the pesticide product or its use on treated articles or
substances were canceled, the treated article or substance would no
longer meet the requirements of Sec. 152.25(a), which specifies that
the pesticide used to treat an article or substance must be registered
for that use.
B. Sec. 155.42--Baseline Dates for Registration Review Cases
In Sec. 155.42(d), EPA proposed to establish a baseline date for
each registration review case. In general, the baseline date would be
the date of initial registration of the oldest product in the
registration review case or the date of reregistration, whichever is
later.
[[Page 45722]]
The date of reregistration would be the date on which either a
Reregistration Eligibility Decision (RED) or an Interim Reregistration
Eligibility Decision (IRED) was signed, whichever date the Agency
determines to be most appropriate.
An industry comment suggested that to avoid duplication of effort,
the Agency should amend Sec. 155.42 to use the date of approval of
significant new uses as the baseline date for the registration review
case.
The Agency intended the baseline date to be the date of the last
comprehensive review. A review of a new use may not be comprehensive--
previously approved uses may not be included in the evaluation of the
new use. Generally, when conducting a registration review of a
pesticide for which a significant new use was recently approved, EPA
would not redo the recent review but would incorporate the risk
assessment for the new use into the registration review.
Another commenter asserted that baseline dates should be either the
initial registration of a pesticide or the completion of the RED. The
commenter stated that the IRED should not be used because it does not
include an assessment of cumulative risk that is required for
pesticides that have a common mechanism of toxicity with other
substances. For such pesticides, the Agency should use the date of the
RED (as opposed to IRED) to establish a common baseline date for all
the pesticides included in the cumulative risk assessment.
The Agency agrees that the RED would update the comprehensive IRED
regarding cumulative risk or other issues but the RED itself may not be
a comprehensive review. For cases where there is both an IRED and a
RED, the Agency needs the flexibility to decide which document
represents a comprehensive review. Accordingly, this final rule allows
the Agency to use the date of either document as the baseline date.
C. Sec. 155.44--Establishing and Announcing Schedules for Registration
Review
1. Chronological vs. risk-based criteria as basis for establishing
schedules for registration review. In Sec. 155.44, EPA proposed that
schedules would be based on the baseline date of the registration
review case or on the date of the last registration review of the
registration review case. The rule allows the Agency to take into
account other factors, such as achieving process efficiencies, when
setting schedules. The preamble of the proposal described other factors
that the Agency might consider. In July 2006, EPA released draft
schedules that were developed using procedures in the proposed rule.
Under the draft schedules, EPA would review chemically related
registration review cases together.
While most commenters supported the proposed chronological
approach, public interest groups and water treatment authorities
advocated risk-based approaches for scheduling. Several industry groups
did not like the chemical groupings in the Agency's draft schedules,
preferring that cases be scheduled for registration review in a
strictly chronological order. They argued that grouping cases together
undermines the chronological order of the schedule and that the order
of groups in the schedule would be based on risk concerns. One industry
group asked the Agency to include in the rule criteria for deviating
from a chronologically based schedule and to consult registrants
regarding the selection of new dates.
While the Agency appreciates that there is a range of views as to
how to set schedules for the registration review program, the
establishment of schedules is within the Agency's discretion. EPA
believes that reviewing similar cases together facilitates decision
making for pesticides with similar scientific or regulatory issues and
would be an efficient use of resources. Registrants or other
stakeholders may notify the Agency regarding particular issues that
could impact the schedule. The Agency would consider such issues as
appropriate.
2. Considerations that could change the registration review
schedule. The Agency may consider factors other than the baseline date
of the registration review case when developing schedules for
registration review. As discussed in Unit IX.E. of the preamble of the
proposed rule and as shown on the draft schedule released in July 2005,
the Agency plans to cluster identified cases belonging to the same
chemical class or group to promote efficiency of review for the Agency
and provide a ``level playing field'' for industry. Additionally,
because the Agency's economic analysis of this regulation suggested
that a small business (i.e., a business that meets criteria established
by the Small Business Administration) might face high data generation
costs if it holds registrations in two or more registration review
cases that are scheduled to undergo registration review in the same
year, the Agency may schedule these cases out of chronological order.
The Agency has a continuing obligation to respond to emerging risk
concerns (discussed in Unit XI.B. of the preamble of the proposed
rule). At any time, the Agency may receive new information that
suggests that the Agency should reevaluate a previous decision to
register a pesticide. After the registration review program begins, the
Agency will continue to address emerging risk concerns. If a pesticide
presents an urgent potential risk of concern, the Agency may opt to
review all other aspects of the pesticide's registration at that time,
rather than only looking at the risk of concern. In such cases, the
Agency may update the registration review schedule by announcing the
new date of the registration review of this case.
In general, the Agency may consider these and other factors,
including issues raised by the public or the registrant when reviewing
a posted schedule, to schedule a pesticide registration review, or to
modify the schedule of a pesticide registration review as appropriate.
3. Three-year schedules. Although the preamble of the proposed rule
contemplated maintaining a 3-year schedule, the proposed rule did not
specify a timeframe. In response to comments requesting this change,
the Agency has modified Sec. 155.44 to specify that the schedules
would cover the current year and at least two subsequent years.
D. Sec. 155.46--Deciding that a Registration Review is Complete and
Additional Review is Not Needed
Under Sec. 155.46, the Agency may propose that no additional
review of a pesticide is needed in order to determine whether the
pesticide continues to meet FIFRA requirements for registration. The
Agency would announce the availability of such proposals and take
comment on them. In response to comments on a proposal made under Sec.
155.46, EPA may reconsider its proposal and schedule a registration
review of the pesticide.
The Agency received one comment asking the Agency to clarify the
purpose of this provision. The purpose of this provision is to give the
Agency flexibility to not schedule a pesticide for registration review
if the pesticide has such low toxicity, exposure or risk that another
review would not change the Agency's position and would not be an
effective use of resources. The Agency may also use this provision for
a pesticide that has recently undergone a comprehensive review. In
proposed decisions issued under Sec. 155.46, the Agency generally
would explain why it believes that no additional review is
[[Page 45723]]
necessary and reference, as appropriate, publicly available
documentation to support the Agency's position.
To clarify the procedures it will use in Sec. 155.46, EPA is
modifying the second sentence to read, ``In such cases, instead of
establishing a pesticide registration review case docket as described
in Sec. 155.50, the Agency may propose that, based on its
determination that a pesticide meets the FIFRA standard for
registration, no further review will be necessary.'' EPA is clarifying
the status of pesticides subject to this section by adding the
sentence, ``The date of the final notice of availability would be used
as the date of the latest registration review for the purpose of
scheduling subsequent registration reviews.''
E. Sec. 155.48--Data Call-In
Section 155.48 provides that, as required by FIFRA section 3(g),
EPA will use procedures in FIFRA section 3(c)(2)(B) to require
submission of data that are needed to conduct a pesticide's
registration review. This paragraph stipulates that the data protection
provisions of FIFRA 3(c)(1), (c)(2)(B), and (c)(2)(D) apply to the
submission, compensation and exemption of data required to conduct a
registration review.
1. Data Call-In procedures. One comment asked why the proposed rule
does not impose any requirements under FIFRA 3(c)(2)(B). The commenter
suggested that additional data collection authorities are needed and
procedures to ensure all necessary data must be included in this rule.
The Agency finds that it is not necessary to develop new procedures
for calling in data for registration review because FIFRA section 3(g)
requires the Agency to use section 3(c)(2)(B) to collect the data, and
that section provides EPA with sufficient authority to obtain any
necessary data.
2. Data compensation for ``voluntarily'' submitted data. Industry
comments asked that the proposed rule clarify the data compensation
status of information voluntarily submitted in response to registration
review. Some comments suggested that the rule specify the mechanisms
for requesting and obtaining a Data Call-In notice (DCI) before the
data are submitted in order to protect data compensation rights. Other
comments suggested that studies used in the registration review
decision, particularly studies generated under revisions to the data
requirements in 40 CFR part 158, be presented in the decision document.
Registrants asked that in addition to determining whether a pesticide
meets the FIFRA risk/benefit standard, EPA should assure that the
registrant of the pesticide is entitled to use data supporting the
risk/benefit determination for the pesticide.
The Agency acknowledges the importance of this issue and agrees
that this concern should be addressed in the conduct of the
registration review program. FIFRA section 3(g)(2)(A) directs the
Agency to utilize section 3(c)(2)(B) to require the submission of data
when such data are necessary for a registration review. Similarly,
FIFRA section 3(g) requires that the data compensation provisions,
including those set forth in sections 3(c)(1), 3(c)(2)(B), and
3(c)(2)(D) ``be utilized for and applicable to any data required for
registration review.'' Hence, to the extent the Agency requires any
data for registration review, such data are eligible for the data
protections provided by the statute.
If a company submits data or information to the docket voluntarily
(as opposed to providing these data or information in response to a
DCI), such data are not ``required'' data eligible for protection under
the statute. However, the Agency may evaluate these data or information
and find that it must rely on this information to support the continued
registration of pesticide products. If the Agency makes such a finding
in the course of a pesticide's registration review, this finding would
be a determination that the voluntarily submitted data or information
are now required. This would be a ``compensable event'' and would
trigger the requirement for compensation to be addressed. The
competitors to the original submitter would be required to submit their
own data or offer data compensation to the data submitter for use of
the study. A ``compensable event'' would also arise should the Agency
issue a Data Call-In Notice for the same data as were previously
submitted voluntarily, but a Data Call-In Notice is not necessary to
trigger compensability should the Agency determine and announce as part
of its registration review decision that the particular data were
required to support the registrations in question.
The Agency's registration review decision document may identify
such data or information and the registration review decision document
may establish a deadline for registrants whose registrations depend on
such data to offer compensation to the owners of the data or submit
their own data. The Agency may cancel the product registration of
registrants who fail to adequately support a registration.
F. Sec. 155.50--Initiate a Pesticide's Registration Review
EPA proposed to establish a docket for each registration review
case, except for cases covered under Sec. 155.46. The docket would
describe information that the Agency may consider in the course of a
pesticide's registration review and describe information that the
Agency does not have that might be useful in the review. The public
would be invited to review information in the docket and submit, within
60 days, any other information that they believe should be considered
in the pesticide's review. A pesticide's registration review begins
when EPA opens the docket for registration review case.
1. Timeframe for submitting comments. As originally proposed, the
timeframe for submitting comments in response to a notice issued under
Sec. 155.50(b) would be ``60 calendar days.'' In response to comments
that this time frame would not be long enough, the Agency is modifying
this paragraph to specify that the time frame for such comment periods
will be ``at least 60 calendar days.''
2. Late submissions. Comments from industry and others asked the
Agency to clarify its position regarding data or information submitted
after the due date established in the notice announcing the opening of
the pesticide registration review case docket.
Under Sec. 155.50(c)(1), the Agency will consider late submissions
if the Agency believes that the new data or information are critical
for the regulatory decision, such as health effects or ecological
effects data or exposure data that the EPA could use to refine a risk
assessment.
If a person has data or information that he/she believes that
Agency should consider during the pesticide's registration review, but
the data or information will not become available before the expiration
of the comment period, he/she may either request an extension of the
comment period, or in accordance with Sec. 155.52, consult with the
Agency regarding a submission date for these materials.
3. Information submitted under Sec. 155.50(c). Comments from
industry asked the Agency to modify Sec. 155.50(c) to specify the
types of information that might be submitted under this paragraph and
to reference quality and scientific criteria for data that might be
submitted as comments during a pesticide's registration review.
In the preamble of the proposed rule, EPA described the kinds of
information that, based on its experience in the pesticide
reregistration program, might
[[Page 45724]]
be useful in registration review. As the Agency and its stakeholders
gain experience in the registration review process, it may become clear
what types of information are most useful. EPA could then develop
appropriate guidance. In accordance with the Data Quality Act, EPA has
already issued guidance regarding the quality of information that it
relies upon for regulatory decisions. This guidance is available at
EPA's website at: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.epa.gov/quality/informationguidelines/.
The Agency will use this guidance in the registration review of
pesticides.
G. Sec. 155.52--Stakeholder Engagement
Under Sec. 155.52, the Agency may meet with registrants or other
stakeholders during a pesticide's registration review or to prepare for
a forthcoming review. This section explains the procedure for releasing
minutes or other material relating to such meetings.
Comments from industry asked that the rule provide an acceptable
framework for activities in the pre-initiation stage. Other commenters
remarked that non-registrants should have more access to the
registration review process and that the public should be able to view
all information, including reports from consumers about adverse
effects. Additionally, they asserted that EPA should announce
consultation opportunities in the Federal Register. Other comments from
industry emphasized their concern that EPA not release confidential
business information.
In this document, the Agency is establishing procedures that
provide the public with the opportunity to participate in the review
process and to review materials that the Agency uses as the basis of
proposed registration review decisions.
The Agency generally does not announce in the Federal Register
meetings with registrants or other stakeholders because it needs the
flexibility to hold such meetings when the need arises. EPA may meet
privately with industry to discuss proprietary or other confidential
business information. Under Sec. 155.52(a) and (b), EPA will place in
the docket minutes of meetings with registrants or other stakeholders.
EPA's protection of information claimed to be confidential business
information is governed by section 10 of FIFRA and the Agency's
regulations in 40 CFR part 2.
H. Sec. 155.53--Conduct of a Pesticide's Registration Review
This section describes how the Agency will assess the significance
of changes in statutes and regulations, risk assessment procedures or
methods, or data requirements and any new information about the
pesticide to determine whether additional review of the pesticide is
warranted. If a new review of the pesticide active ingredients or
individual products in a registration review case is needed, the Agency
will determine whether additional information is necessary to conduct
the review. This section also provides for public review and comment
during the review process. Under the proposed procedures, the Agency
would generally establish comment periods of ``at least 60 calendar
days,'' except in Sec. 155.53(c) where the comment period is ``at
least 30 calendar days.''
1. Agency's approach for conducting registration review. The Agency
received several comments that disagreed with the Agency's proposed
approach for conducting a pesticide's registration review. An industry
trade association reiterated comments made in response to the April
2000 Advance Notice of Proposed Rulemaking (65 FR 24585, April 26,
2000) (FRL-6488-9) that the Agency should use a checklist or decision
tree for deciding whether a pesticide continues to meet the
requirements for registration. Other stakeholders expressed concern
that the proposed approach was not sufficiently rigorous and would lead
to relaxed standards.
In the preamble of the proposed rule, the Agency described
alternative approaches for conducting a pesticide's registration review
and explained why it selected the proposed approach. The comments do
not raise issues or concerns that would alter EPA's choice of approach.
It is important to note, however, that although the Agency has not
chosen to use a pure checklist approach, it is using a decision
paradigm that ensures that the process will be transparent while still
providing sufficient flexibility to allow for the scope and depth of a
particular review to be tailored to the circumstances of the particular
registration review case.
2. Review of individual product registrations. Some registrants
expressed their belief that the Agency should conduct a comprehensive
review of individual product registrations to assure adequacy of
product labels, product-specific data, and any claims for generic data
exemption under FIFRA section 3(c)(2)(D).
As explained in the preamble of the proposed rule, during the
comment period on the initial registration review case docket, the
public may comment on the need for a new review of individual product
registrations. The Agency will continue to comply with its data
protection obligations under FIFRA section 3(c)(2)(D).
3. Public participation procedures. Several commenters noted that
under the Agency's procedures for public participation in the
reregistration and tolerance reassessment programs, the Agency may
announce the availability of a revised risk assessment and may invite
the public to suggest approaches for mitigating the risks identified in
the revised risk assessment. The proposed procedures for registration
review did not provide this opportunity.
In response to this comment, the Agency is revising Sec. 155.53(c)
so that it may provide the public an opportunity to comment on possible
risk mitigation when a revised risk assessment shows risks of concern.
However, if immediate action is warranted, the Agency may initiate
cancellation or suspension procedures under FIFRA section 6. In this
event, the Agency would not provide the opportunities for public
comment described in Sec. 155.53(c) but would follow procedures in
FIFRA section 6, as appropriate.
4. Length of comment periods. Several commenters asserted that the
comment periods provided in the proposed regulation were not long
enough.
Generally, where EPA publishes a document for comment, the Agency
considers requests for extension if a reasonable basis for extension is
provided. It is not necessary to modify these regulations to provide
for extending comment periods.
I. Sec. 155.57--Registration Review Decision
This section states that a registration review decision is the
Agency's determination whether a pesticide meets, or does not meet, the
standard for registration under FIFRA.
1. Goal of registration review. The California Stormwater Quality
Association asserted that the goal of registration review should be to
protect water quality and minimize the need to mitigate pesticide
impacts through Clean Water Act (CWA) mechanisms.
The Agency believes that the goal of registration review is set
forth in FIFRA section 3(g) and reiterated in Sec. 155.40.
Registration review is a determination whether a pesticide continues to
meet the FIFRA standard for registration, including, among other
things, that the pesticide does not cause unreasonable effects on the
environment. As part of this review, EPA will assess the effects of
pesticides on water quality. However, while meeting CWA standards is
important, it is not the only goal of registration review.
[[Page 45725]]
2. FIFRA standard for registration. (a) Comments from industry
strongly oppose EPA's intention to consider a pesticide's benefits
during registration review. The comments referred to a discussion in
the preamble of the proposed rule where EPA explained that it would
evaluate information about the benefits of a pesticide with known high
risks during registration review if a new and safer alternative to a
pesticide has become available. The comments asserted that it is
inappropriate for the Agency to base continued registration of a
pesticide on a comparative benefits assessment with other pesticides.
The comments cited FIFRA section 3(c)(5) to support their assertion
that when pesticides meet the registration criteria of FIFRA, the
Agency should not be allowed to make marketplace decisions of one
product over another. FIFRA section 3(c)(5) states, ``The Administrator
shall not make any lack of essentiality a criterion for denying
registration of any pesticide. Where two pesticides meet the
requirement of this paragraph, one should not be registered in
preference to the other.''
EPA believes the commenter misapprehends the nature of FIFRA's
risk-benefit balancing standard. A determination that a pesticide meets
the registration standard under FIFRA at one time does not necessarily
mean that the same pesticide will meet the standard at all times in the
future, even if the science associated with the risks posed by the
pesticide does not change. Significant changes in the benefits picture,
such as the development of pest resistance or new alternatives, can
also affect whether a pesticide continues to meet the FIFRA
registration standard. EPA does not intend to compare benefits of two
or more pesticides that do not pose risks of concern. As the commenters
noted, EPA may not make a determination of essentiality when two
pesticides meet the FIFRA requirements for registration. However, when
there are risks of concern for a pesticide, FIFRA requires EPA to weigh
those risks against the benefits of that pesticide to determine whether
the risks are unreasonable. Benefits are the advantages that accrue to
the pesticide users or society in general, such as increased
production, decreased production costs, pest-free homes, or disease-
vector control. The magnitude of those benefits often depends on the
availability of alternative pest control measures, whether chemical,
biological or cultural. Benefits are, in general, expected to be higher
when there are no viable alternatives.
During registration review, EPA may reassess a pesticide that has
remained registered even though high risks are associated with the use
of the pesticide. In its earlier review, the Agency may have found that
the pesticide did not pose unreasonable risk because of the high
benefits of the pesticide. In registration review, EPA may find that
existing risk assessments that identify these risks of concern are
still valid. EPA would then determine whether the pesticide continues
to provide sufficient benefits to justify maintaining the registration.
The benefits finding could depend on whether new, safer alternatives
have been registered since EPA's earlier decision. EPA conducted
similar analyses in the reregistration program.
If EPA's review of a pesticide's registration appears to show that
the pesticide does not meet the FIFRA standard for registration, EPA
would follow procedures in FIFRA section 6 to change, cancel or suspend
the pesticide's registration. This section sets out where it requires
EPA to assess the benefits of the pesticide and provides opportunities
for public hearings on whether the pesticide's registration should be
changed, canceled, or suspended. The Agency would not analyze benefits
when a registrant responds to the Agency's registration review finding
by agreeing to the cancellation of a pesticide or termination of one or
more of its uses under FIFRA section 6(f). However, FIFRA provides the
public an opportunity to comment on the proposed action.
(b) Another registrant asserted that the registration review
regulations should contain language that specifically reaffirms the
standard of imminent hazard and substantial risk as the basis for
cancelling pesticide registrations. He cited a specific product example
to illustrate his belief that the Agency employed a ``zero tolerance
agenda'' during reregistration.
The standard of ``imminent hazard'' referred to by the commenter
applies to suspensions and emergency suspensions under FIFRA section
6(c). This section sets forth the standard for a suspension or an
emergency suspension. This is not the standard that the Agency will use
in making registration review decisions. The Agency interprets
registration review to be a determination that a pesticide continues to
meet the standard for registration in FIFRA section 3(c)(5), or, where
appropriate, section 3(c)(7). This standard specifies, among other
things, that a pesticide may not pose unreasonable risk to man or the
environment.
When a pesticide poses risks of concern to humans or the
environment, the Agency must address these risks. The options for
addressing such risks include risk mitigation, determining that the
risks are justified in light of the benefits of the pesticide, or
initiating regulatory options to modify or cancel the registration. EPA
generally consults with registrants and other stakeholders when
deciding how to mitigate a risk. In addition, EPA has modified the
proposed public participation procedures for registration review to
generally add a public comment period when a pesticide poses risks of
concerns so members of the public can provide suggestions for reducing
the risk. This procedure provides registrants and other stakeholders an
opportunity to provide input on the Agency's risk management decisions.
J. Sec. 155.58--Procedures for Issuing a Decision on a Registration
Review Case
In this section, EPA explains that it will issue proposed
registration review decision documents for public review and comment.
In comments on the proposed rule, various stakeholders advised the
Agency of their expectations and needs regarding the documentation of
registration review decisions and suggested how this documentation
might be presented. EPA appreciates these suggestions. The Agency has
consulted the Pesticide Program Dialogue Committee and has considered
their recommendations together with comments submitted on the proposed
procedural regulations. Nothing in the comments indicates the need to
modify the regulation to specify the format of the registration
decision document.
VII. Comments on the Operation of the Registration Review Program
A. Scope of the Registration Review Program
1. Is registration review a safety net? In the preamble of the
proposed rule, the Agency described how it intended to use registration
review as the framework for managing the regulatory status of existing
pesticides.
Industry trade associations did not agree with this approach. In
their comments, they asserted that EPA should not expand registration
review beyond the intent of Congress because to do so risks repeating
the Agency's experience with reregistration which began as a 5-year
program in 1972 and still has not been completed. They asserted that
registration review should not be a catch-all for other programs and
actions. For example, special review, actions under FIFRA section
3(c)(8),
[[Page 45726]]
FIFRA section 6 or the Pesticide Registration Improvement Act (PRIA)
should not be included in the registration review program. They believe
that new programs such as endocrine disruptor screening and testing
should be conducted independently of registration review. The industry
comments advocate that, as far as possible, registration review should
be a safety net.
EPA does agree that registration review is not the only mechanism
for addressing pesticide registration issues, and will continue to use
other provisions of FIFRA to address particular registration issues.
However, EPA does not agree with the comment that registration review
should function solely as a safety net to discover and resolve issues
missed or overlooked in registration, tolerance reassessment, or
reregistration activities. While EPA expects that it will occasionally
discover issues that were overlooked in previous reviews, the purpose
of registration review is to consider the pesticide in light of new
knowledge that was not available for previous reviews.
EPA interprets the Congressional mandate for registration review to
be a periodic assessment whether a pesticide continues to meet the
FIFRA standard for registration in light of new knowledge. Therefore,
the scope of a pesticide's registration review includes all aspects of
a pesticide's registration specified in section 3(c)(5) of FIFRA with
respect to product composition, labeling and other required material,
and risks and benefits. Registration of new pesticides or new uses of
pesticides under PRIA is a separate program from registration review.
However, in evaluating a new use under PRIA, the Agency would consider
all relevant information, including information that it might consider
during the pesticide's registration review.
2. Incorporating evolving or new programs into registration review.
As explained in the preamble of the proposed rule, EPA intends to
incorporate new requirements, such as endocrine disruptor screening and
testing or endangered species assessments into the registration review
program as these aspects of risk assessment mature into routine
evaluations for pesticides.
Industry commenters advised the Agency to avoid using registration
review as the sole process for handling new issues. They asserted that
attaching all these assessments (endangered species assessments,
endocrine disruptor screening and testing, review of substitutes, etc.)
to a program intended to accomplish periodic review of all pesticides
will undermine the timeliness of the review process for a great many
pesticides. Commenters believe that this may result in an ever-changing
schedule that will deprive registrants and users of predictability and
lead to significant inefficiencies within the Agency.
Again, EPA does not intend to use registration review as the only
mechanism for addressing pesticide registration issues. However, EPA
believes it is appropriate to use registration review as the framework
for managing its responsibilities regarding existing pesticides. In
making a FIFRA section 3(c)(5) decision as required under FIFRA section
3(g), EPA must consider all information that pertains to that decision.
EPA regards endangered species assessments required under the
Endangered Species Act or endocrine disruptor screening and testing
required under the Federal Food, Drug, and Cosmetic Act as part of the
risk characterization of the pesticide that is intrinsic to the FIFRA
risk/benefit decision. If knowledge exists on these or other scientific
issues at the time of a pesticide's registration review, the Agency
believes it must consider them when it makes its FIFRA (3)(c)(5)
finding.
3. Managing emerging issues. In the preamble of the proposed rule,
the Agency explained that it will continue to give priority to emerging
risk concerns. While reviewing the new risk concern, the Agency may
find that it would be more efficient to review all other aspects of the
pesticide's registration at the same time. The procedural regulations
for registration review provide flexibility to amend the schedule to
advance the registration review of a pesticide in this circumstance.
The Agency would provide as much advance notice as possible regarding
such changes in the schedule.
Commenters took exception to EPA's approach for managing emerging
issues arguing that newly discovered risks of potential concern should
be dealt with outside of registration review if the risks are urgent.
The commenters believe that registration reviews should not be
rescheduled under this circumstance.
The Agency does not agree that it should reassess the approach
described in the preamble of the proposed rule. EPA fully explained its
reasoning in the proposed rule and the comments do not persuade it
otherwise. This is not to say that the Agency will not address urgent
risks of concern outside the registration review process if the Agency
determines that to be the appropriate course of action.
4. Assessing risks of substitute pesticides. In the preamble of the
proposed rule, EPA explained that it might advance the registration
review of pesticides that are potential substitutes for a pesticide or
some uses of the pesticide that are being canceled under FIFRA section
6 because of risk concerns.
Industry commenters expressed concern that EPA would even consider
using the registration review program to address reviews that might be
the outgrowth of cancellation proceedings.
EPA generally would assess risks of substitute pesticides as part
of the cancellation process in FIFRA section 6. In the rare event that
it is necessary to perform a comprehensive review of a substitute
pesticide, such a review might be tantamount to conducting the
registration review of that pesticide. In such cases, EPA might find
that it would be more efficient to conduct the registration review of
the pesticide at the same time.
5. Review of inert ingredients. In the preamble of the proposed
rule, EPA explained that it would handle inert ingredients in a process
that is separate from registration review.
Some commenters agree with EPA's approach of dealing with inert
ingredients. However, others question the need to review inert
ingredients at all. A public interest group expressed concern that
having separate review processes for active ingredients and inert
ingredients could result in missing or ignoring synergistic effects of
mixtures of ingredients.
The Agency intends to follow the procedures outlined in the
preamble of the proposed rule. The Agency recognizes that there may be
interactions among the various chemicals in pesticide products.
Currently, the Agency requires acute toxicity data for end-use
products, i.e., formulations containing active and inert ingredients.
These studies address, albeit to a limited extent, potential
synergistic effects of mixtures of active and inert ingredients in a
pesticide product. However, to test and review all of the potential
combinations of ingredients would require significant resources. The
Agency will consider new scientific methodologies to identify potential
interactions among chemicals, should they become available.
B. Data and Information Collection in the Registration Review Program
In the preamble of the proposed rule, the Agency described
strategies for acquiring information to support a pesticide's
registration review including issuing Data Call-In notices to require
[[Page 45727]]
data necessary to conduct a review and searching the published
literature for pertinent information about a pesticide. The Agency
explained that early acquisition of data or information that could be
useful in refining a pesticide's risk assessment would reduce the time
and effort needed to complete the review of a pesticide. As explained
in the preamble, EPA might be able to identify data or information
needs when it publishes the schedule for a pesticide's registration
review. In some cases, data or information needs might become apparent
when the Agency assembles the initial docket for the registration
review case. In this event, the docket for the registration review case
would identify data or information needs. In other cases, the Agency
might not be able to identify data or information needs until it
evaluates the information in the initial docket.
1. Identification of information that may be used to refine risk
assessments. An industry trade group acknowledged EPA's concern about
redoing risk assessments when, in response to a preliminary risk
assessment, a registrant or other stakeholder submits new data or
information to refine the preliminary risk assessment. However, they
believe that such iteration is inevitable. When registrants conduct
their own risk assessments, they may use different assumptions or
interpretations of data than the Agency uses in its risk assessments.
When the Agency's risk assessment shows higher risks than the
registrants found in their own assessments, they must either develop
data or information to refine the risk assessment or cancel uses.
EPA agrees that some iteration may be inevitable. However, the
Agency publishes its risk assessment methods, including its approach
for interpreting data. So it may be possible for registrants to
anticipate the Agency's information or data needs in a forthcoming
registration review and to reduce the degree of iteration in the risk
assessment process.
2. Information developed under the Clean Water Act. In public
discussions about the proposed rule, EPA received a suggestion from
water treatment authorities that the Agency might consider information
developed under section 303(d) of the Clean Water Act, which identifies
impaired water bodies.
In comments, States raised the concern that they do not have the
resources to assemble such data. Registrants expressed their concern
that these data not be taken at face value because the criteria and
process used to develop these data might affect the reliability of this
information.
EPA believes that information on water quality may be useful in
registration review and will make efforts to obtain State data for CWA
section 303(d) listings due to pesticides. When evaluating such data,
EPA will take into account the procedures used to develop the data to
assess the quality and usefulness of the data.
C. Work-Sharing
The preamble of the proposed rule described the Agency's intention
to develop work-sharing agreements with its partners in the
Organization for Economic Cooperation and Development (OECD) or the
North American Free Trade Agreement (NAFTA). In comments on the
proposed rule, industry trade associations expressed concern that
conducting reviews jointly with EPA's NAFTA or OECD partners might
cause delays.
EPA continues to believe that harmonization and work-sharing will
result in process efficiencies and superior decisions. Since EPA's
partners also have programs for reassessing pesticides, all parties
could benefit by coordinating their efforts. EPA and its Canadian
counterpart have begun discussions for work-sharing during registration
review with the expectation that they will develop a work-sharing plan
by the December 2006 meeting of the NAFTA Technical Working Group on
Pesticides.
EPA gave a presentation on the registration review program at the
February 2006 meeting of the OECD Working Group on Pesticides. EPA
intends to continue encouraging the OECD community to participate in
work-sharing efforts.
EPA may adjust its schedule slightly to take advantage of these
potential opportunities for work-sharing.
D. Adequacy of EPA's Methods for Assessing Potential Risk to Water
Quality
California water-treatment authorities questioned the adequacy of
EPA's assessment of risks with regard to water quality considerations
including: Use of aquatic toxicity testing, surface water quality
studies, and urban uses of pesticides, particularly when these uses
result in pesticide residues in receiving waters for storm sewers or
sewage treatment plants. The commenters reported that in some cases,
pesticide residues in water released by a sewage treatment plant may
exceed its NPDES permit, which would be a violation of the Clean Water
Act. They also noted that residues from agricultural uses of
pesticides, e.g., rice pesticides and pesticide degradates have been
found in drinking water supplies.
The Office of Pesticide Programs (OPP) will manage water-related
issues within the framework of the registration review of pesticides.
OPP expects that its capacity for characterizing risk will continue to
improve as it works with the Office of Water to refine its models for
estimating exposures and as more monitoring data become available.
E. Achieving Label Improvement through the Registration Review Program
Several commenters see the registration review program as an
opportunity to improve the quality of labels on individual pesticide
products. One aspect of label improvement would be to minimize the
number of different labels for the same product. According to comments,
this situation arises because many States require State registration
and impose their own labeling requirements.
The Agency is committed to improving the consistency of labels. EPA
already works with States on labeling issues. However, the Agency notes
that section 24(b) of FIFRA prohibits States from establishing or
maintaining labeling requirements. The Agency agrees that label
improvement is a worthwhile goal for the registration review program.
VIII. Implementation Issues
A. Coordination of the Registration Review Rule with the Data
Requirements Rule
Industry comments asserted that EPA should delay implementing
registration review until the recently proposed revisions to the data
requirements in 40 CFR part 158 have been finalized. They stated their
belief that EPA cannot make registration review decisions until it has
completed revising the data requirements for the registration of
pesticides. Industry is concerned that if registration review is
initiated before a final rule on data requirements, different standards
will apply to cases reviewed early in the program, negating one of the
benefits of the review: to reduce market barriers.
The Agency does not believe it is appropriate to delay
implementation of the registration review program as suggested in the
comments. In the absence of updated part 158 rules, the Agency makes
case-by-case data determinations as a standard program practice.
Registrants are familiar with this practice. While the Part 158 Data
Requirements Rules and registration review decisions are related, they
are
[[Page 45728]]
not inextricably linked. The revisions to part 158 have benefits but
they are not a condition precedent to making registration review
decisions.
The part 158 updates may include provisions to codify current
practices. The purpose of the part 158 rule is to capture with clarity
and transparency changes in data requirements or application of data
requirements that the Agency has made on a case-by-case document since
it published its data requirements in 1984. This good-government goal
will amplify understanding and further enhance consistency. However,
the registration review program can operate effectively, as the
registration, reregistration, and tolerance reassessment programs have,
in the absence of these enhancements. Final promulgation of the part
158 rules will simply improve on that sound foundation.
Science will continue to evolve even after the Agency has completed
the current revision of the data requirements in 40 CFR part 158. The
Agency expects that it will change its data requirements to reflect
this new knowledge. Because one of the goals of registration review is
to incorporate evolving science, the Agency fully expects that it might
apply new and different risk assessment tools to pesticides reviewed
later in the 15-year cycle than it used when it reviewed pesticides
early in the 15-year cycle.
The Agency appreciates the commenter's concern about market
barriers that might arise if the Agency uses different risk assessment
tools when reviewing pesticides later in the 15-cycle than it used
earlier in the cycle. Market barriers can be reduced if similar
pesticides are reviewed at the same time. This is one of the benefits
of the Agency's plan to group chemically related cases for review.
B. Transition from Reregistration to Registration Review
Industry comments asserted that EPA must clarify when the
registration review program will begin. EPA should address how it will
handle the work of registration actions, reregistration actions, and
other mandated regulatory actions before it commits to initiating the
registration review program. EPA should clarify the transition process
between the reregistration and registration review programs.
The Agency has announced that the registration review program
officially begins when these regulations go into effect. The Agency's
first actions under the new program will be to issue schedules and to
begin to open registration review case dockets. As noted in the
comment, some pesticides will still be undergoing reregistration when
the registration review program begins. The Agency recognizes that, to
avoid confusion during the transition between the reregistration and
registration review programs, it must clearly communicate whether
action on an existing pesticide is taken under reregistration (FIFRA
section 4) or registration review under FIFRA section 3(g).
C. Unresolved Problems from Reregistration Will Affect the Agency's
Capacity to Conduct Registration Review
Industry commented that EPA should not implement registration
review of end-use products until it fixes the problems with the review
of end-use products in reregistration. The review processes in
registration review and reregistration are likely to be similar and
registration review might duplicate the effort of reregistration,
especially when a product may undergo product-specific review several
times (e.g., a product that contains two or more active ingredients may
belong in two or more registration review cases). The commenters are
concerned that if EPA does not achieve efficiencies in the review of
end-use products, the 15-year review will extend to 40 years.
EPA expects reregistration to satisfy most product-specific data
requirements and achieve many label improvements for end-use products.
Although the Agency does not expect it will routinely require product-
specific data during registration review, it expects that registration
review will be an important vehicle for the continuing update of
labels. The Agency agrees that the review of end-use product labels
could benefit from process improvements. The Agency believes that
registrants and other stakeholders can help develop approaches to make
this process more efficient.
IX. Program Costs
A. Impacts on Small Businesses
Registrants commented that EPA has not accurately characterized the
effects of registration review on small business. They suggested that
per-company costs of $750,000 and 2% gross sales are not insignificant
even for large entities and will have a direct adverse effect on small
businesses. They believe that the cost projections are misleading
because they do not include all costs incurred by a registrant such as
existing reporting, recordkeeping, and financial burdens imposed by the
Agency's many other on-going programs. Commenters suggested that EPA
should re-evaluate the impacts on small business and reduce economic
burden on them.
EPA believes it has accurately characterized the impacts of the
registration review procedures on the regulated community, including
small businesses. The procedures in this rule establish what EPA will
do to review a pesticide registration. They do not obligate a
registrant to take any action.
As part of the rulemaking process, EPA is required to estimate the
economic impacts, including effects on small business, that occur as a
consequence of the rule. Because costs resulting from existing
reporting or recordkeeping requirements or costs from other Agency
programs are not imposed by this rule, these costs are not included in
the Agency's assessment of the impacts of this rule.
The regulations do not impose new data requirements. They establish
the process by which EPA will decide if additional data are necessary
to determine whether a pesticide continues to meet FIFRA standards.
That is, data generation costs are only indirectly a result of
registration review procedures. It is important to realize that the
per-company costs of $750,000 are primarily the cost of data
generation; that is, they are not a direct cost imposed by this rule.
The Agency has determined that this rule will not have a
significant adverse impact on a substantial number of small businesses.
Nonetheless, the Agency recognizes that, from the perspective of a
small business whose product is undergoing registration review, the
costs of data generation in registration review could be significant.
Accordingly, the Agency is willing to work on a case-by-case basis with
a small business for whom the requirements for data generation in
registration review are burdensome. Data Call-In notices issued under
FIFRA section 3(c)(2)(B) allow a registrant to request a data waiver
that is based on economic factors. In lieu of a new study, the Agency
is generally willing to consider whether substitute data or bridging
data would be adequate. If a new study is required, the Agency may
consider time extensions so that a registrant can spread the costs of
data generation over a longer period of time. The Agency has made these
options available to small businesses in the registration and
reregistration programs and expects to continue to make them available
for registration review.
B. Cost of Product-Specific Data
Industry comments asserted that the economic assessment was
incomplete
[[Page 45729]]
because it did not include the costs of generating product-specific
data, in particular, the costs of repeating efficacy tests for public
health pesticides. At public meetings on the proposed rule, the Agency
said that it would require new product efficacy tests.
These comments accurately describe the scope of the feasibility
study. The purpose of the feasibility study was to test the validity of
the registration review decision paradigm and to develop data for
estimating the costs of the program. The Agency did not review
individual product registrations in the feasibility study to determine
whether new product-specific data, including efficacy data, would be
required because the Agency believes that, to a great degree, these
product-specific data requirements have been satisfied through the
registration and reregistration programs and such data would generally
not be needed to support a pesticide's registration review.
During the registration review of a public health pesticide, the
Agency would determine whether to continue to base the product's
registration on existing product efficacy data. The Agency may ask for
new product efficacy data if the product's composition has changed so
that existing data no longer support the current composition of the
product, or the test method is no longer valid, or there is information
suggesting that the formulation might not be efficacious as claimed.
The Agency did not review product chemistry data in the feasibility
study to make case-by-case determinations whether existing product
efficacy tests are appropriate for the composition of the product. The
Agency has not revised antimicrobial efficacy test methods, so, for
purposes of the feasibility study, the existing efficacy tests were
considered to be valid. (If the Agency had information suggesting that
a product in the feasibility study was not efficacious as claimed, the
Agency would not wait until registration review to ask for new efficacy
data. The Agency would have issued a DCI or initiated other action
under FIFRA, as appropriate.) The Agency believes that the costs of
replacing product efficacy data for a few products in a registration
review case will be much lower than the costs of generating new generic
data to support the active ingredient(s) in a registration review case.
In any case, any costs for generating new product-specific efficacy
data would not be a direct cost imposed by this procedural regulation.
X. Technical Changes to the Rule
In addition to the changes made in response to comments, the final
rule reflects that the Agency made the following technical changes to
what was proposed:
1. In Sec. 155.42(d), the Agency added clarifying phrases
(indicated in italics) to the second and third sentences, as follows:
``In general, the baseline date will be the date of initial
registration of the oldest product in the case or the date of
reregistration, whichever is later. The date of reregistration is the
date on which the Registration Eligibility Decision or Interim
Reregistration Eligibility Decision was signed, whichever date the
Agency determines to be more appropriate based on the comprehensiveness
of the review.''
2. In Sec. 155.44, EPA is deleting the sentence, ``As indicated in
Sec. 155.40, the Agency may change the schedule of a pesticide's
registration review if circumstances warrant,'' because it is not a
correct reference.
3. In Sec. 155.48, EPA is deleting the phrase ``before, during or
after a registration review'' because it is redundant.
4. The Agency is modifying Sec. 155.50 as follows:
In the first sentence add the phrase ``except for cases
covered under Sec. 155.46.'' The sentence now reads, ``The Agency will
initiate a pesticide's registration review by establishing a docket for
each registration review case, except for cases covered under Sec.
155.46, and opening it for public review.''
Change the paragraph heading of Sec. 155.50(a) to
``Contents of the registration review case docket.'' The Agency has
deleted the first sentence of this paragraph and modified the last
sentence to read, ``The Agency will consider including, but not limited
to, the following information: . . .'' The Agency is making these
changes to make clear that this paragraph describes the contents of the
initial docket.
Change Sec. 155.50(c) by adding ``during the comment
period'' to the paragraph heading and by changing the first sentence in
paragraph (c)(1) to read as follows: ``In order to ensure that the
Agency will consider data or information in the conduct of a
registration review, interested persons must submit the data or
information during the comment period established in the notice
described in paragraph (b) of this section.'' These changes are for
clarity.
Add paragraph Sec. 155.50(d) as follows, ``For the
purposes of this subpart, the provisions of subpart B do not apply.''
EPA is making this change to eliminate any possible confusion as to
whether docketing procedures in part 155 subpart B apply to
registration review activities. Subpart B describes docketing and
public participation procedures for the registration standard program
that the Agency conducted before it began the reregistration process
mandated in the 1988 amendments to FIFRA. The Agency will eventually
issue a housekeeping rule to delete this subpart.
5. In Sec. 155.52, the Agency is making editorial changes for
clarity, as follows:
Substitute ``other persons'' for ``public interest
groups'' in the third sentence so that it reads, ``The Agency may
consult with registrants, pesticide users, or other persons during a
pesticide's registration review . . .''
Add the phrase ``Minutes of'' to the paragraph heading of
Sec. 155.52(a) so that it reads, ``Minutes of meetings with persons
outside of government.''
6. In Sec. 155.53, the Agency is making several editorial changes
for clarity, as follows:
Add the preposition ``of'' to the section heading of Sec.
155.53 so that it reads, ``Conduct of a pesticide's registration
review.''
In the first sentence of this section, replace the
reference to ``Sec. 155.51,'' which doesn't exist, with ``Sec.
155.50(a), (b), and (c).''
In the first sentence of Sec. 155.53(c)(1), replace the
phrase ``ask for'' with the verb ``request.''
7. In Sec. 155.58, the Agency is making an editorial change in
paragraph (b)(3) by deleting the phrase ``precede, accompany or
follow'' from the second sentence and replacing it with the phrase
``may be issued in conjunction with.''
XI. FIFRA Review Requirements
In accordance with FIFRA section 25(a) and 25(d), this rule was
submitted to the FIFRA Science Advisory Panel (SAP), the Secretary of
Agriculture (USDA), and appropriate Congressional Committees.
XII. Statutory and Executive Order Reviews
A. Executive Order 12866
Pursuant to Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), the Office of Management and
Budget (OMB) has designated this rule as a ``significant regulatory
action'' under section 3(f) of the Executive Order because it may raise
novel legal or policy issues arising out of legal mandates, the
President's priorities, or the principles set forth in the Executive
[[Page 45730]]
Order. This action was therefore submitted to OMB for review under this
Executive Order, and any changes to this document made at the
suggestion of OMB have been documented in the public docket for this
rulemaking.
EPA has prepared an economic analysis of the potential impacts of
the registration review procedures. In addition to analyzing the
requirements contained in this rule, the Agency analyzed other
potential actions that could occur during a registration review using
other existing authorities that are not changed in this rule. The
Agency's analysis, therefore, considers the potential impact of the
registration review process, which includes the costs of a registrant's
participation in the public review components of the process described
in this rule and other potential requirements imposed by existing
authorities such as data generation under FIFRA section 3(c)(2)(B).
This analysis is contained in a document entitled Economic Analysis of
the Procedural Regulations for the Registration Review of Pesticides.
EPA placed a copy of this Economic Analysis in the public docket for
this action when it published the proposed rule. Comments on the
Economic Analysis did not warrant revision of this document and the
Agency will rely on this document to support the final rule. The
Economic Analysis is briefly summarized here.
The rule does not require registrants to take specific action as
part of the review of a pesticide registration, however, the Agency's
analysis assumes that registrants will engage in their own evaluation
of information provided by the Agency and other stakeholders, and
participate in the public process described in this rule. The Agency
estimates such industry costs to be around $1.2 million annually.
The Agency recognizes that under other existing authorities a
registrant may also need to submit data that they have or generate data
as necessary to support the registration. As such, the analysis also
considers the potential cost to industry from other anticipated
activities under existing authorities that may occur during the
registration review process, although such activities are not
requirements in this rulemaking. These activities include potential
data submission or generation activities related to DCIs, including the
paperwork burden, and other activities that might occur under other
existing authorities.
Considering these other potential activities, the analysis shows an
estimated total annual cost to industry of about $50 million, with the
estimates for potential data generation activities accounting for
approximately 70% of these costs. The Agency estimates about 68
companies will be impacted each year; thus, per-company costs for the
entire registration review process are likely to average less than
$750,000 each year, even though some companies may have multiple
chemicals under review during the year. Out of the universe of 2,000
small businesses estimated to hold pesticide registrations, the Agency
estimates that each year about 30 small businesses that have
responsibility for providing data to support the registration of a
pesticide would be involved in a registration review. Assuming the same
level of participation and potential need to generate data, the
estimated average cost of the registration review process is estimated
to be less than 2% of the gross sales for small businesses involved in
a registration review.
B. Paperwork Reduction Act (PRA)
The information collection activities associated with the
registration review program are already approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act, 44
U.S.C. 3501 et seq. That Information Collection Request (ICR) document
has been assigned EPA ICR number 0922.07, and OMB control number 2070-
0057. Although this action does not impose any new information
collection requirements that would require additional approval by OMB,
the Agency expects the approved burden estimate to increase with the
full implementation of the registration review process. A copy of the
OMB approved ICR has been placed in the public docket for this rule,
and the Agency's estimated burden increase is presented in the economic
analysis that has been prepared for this rule.
As detailed in the Economic Analysis prepared for this rule, the
annual respondent burden for information collection activities
associated with the registration review program is estimated to average
120,000 hours, with an estimated total annual respondent cost of
$10,800,000. The July 13, 2005, proposed rule invited comments on the
Agency's need for this information, the accuracy of the provided burden
estimates, and any suggested methods for minimizing respondent burden,
including the use of automated collection techniques. No comments were
received. Therefore, the Agency has submitted an information correction
worksheet request to OMB to amend its existing ICR covering the
information collection activities associated with the registration
review program so that it reflects the burden estimates in the Economic
Analysis.
Under the PRA, ``burden'' means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
or disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information.
Under the PRA, an agency may not conduct or sponsor, and a person
is not required to respond to a collection of information unless it
displays a currently valid OMB control number. The OMB control numbers
for EPA's regulations codified in Chapter 40 of the CFR, after
appearing in the preamble of the final rule, are listed in 40 CFR part
9, are displayed either by publication in the Federal Register or by
other appropriate means, such as on the related collection instrument
or form, if applicable. The display of OMB control numbers in certain
EPA regulations is consolidated in 40 CFR part 9. For the ICR activity
contained in this final rule, in addition to displaying the applicable
OMB control number in this unit, the Agency is amending the table in 40
CFR 9.1 to list the OMB control number assigned to this ICR activity.
Due to the technical nature of the table, EPA finds that further notice
and comment about amending the table is unnecessary. As a result, EPA
finds that there is ``good cause'' under section 553(b)(B) of the
Administrative Procedures Act (APA), 5 U.S.C. 553(b)(B), to amend this
table without further notice and comment.
C. Regulatory Flexibility Act
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA),
5 U.S.C. 601 et seq., the Agency hereby certifies that this rule will
not have a significant adverse economic impact on a substantial number
of small entities. This rule defines the procedures that EPA will
follow to implement the statutory registration review provision. It
does not impose any new requirements on the regulated community. As
such, this rule does not have direct adverse impacts on small
businesses, small non-profit
[[Page 45731]]
organizations, or small local governments.
For purposes of assessing the impacts of this rule on small
entities, small entity is defined as: (1) A small business as defined
by the Small Business Administration's (SBA) regulations at 13 CFR
121.201, which for the pesticide industry consists of businesses with
fewer than 500 to 1,000 employees (range is based on NAICS sector
variations); (2) a small governmental jurisdiction that is a government
of a city, county, town, school district or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field. The regulated community does not
include any small not-for-profit organizations. Small local government
organizations, such as counties, may register a pesticide under FIFRA
section 24(c). However, such registrants generally do not manufacture,
distribute or sell pesticides and generally would not be responsible
for generating data to support the registration of pesticides.
Accordingly, the Agency finds that this rule does not have a direct
adverse effect on small local governments.
D. Unfunded Mandates Reform Act
Under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA)
(Public Law 104-4), EPA has determined that this action does not
contain a Federal mandate that may result in expenditures of $100
million or more for State, local, and tribal governments, in the
aggregate, or the private sector in any one year. As described in Unit
XIII.A., this rule is not expected to result in such expenditures. In
addition, this action will not impact small governments, or local or
tribal governments. Accordingly, this rule is not subject to the
requirements of sections 202, 203, 204, and 205 of UMRA.
E. Executive Order 13132
Pursuant to Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999), EPA has determined that this rule does not
have ``federalism implications,'' because it will not have substantial
direct effects on the states, on the relationship between the national
government and the states, or on the distribution of power and
responsibilities among the various levels of government, as specified
in the Order. Thus, Executive Order 13132 does not apply to this rule.
F. Executive Order 13175
As required by Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000), EPA has determined that this rule does not have tribal
implications because it will not have any affect on tribal governments,
on the relationship between the Federal government and the Indian
tribes, or on the distribution of power and responsibilities between
the Federal government and Indian tribes, as specified in the Order.
Thus, Executive Order 13175 does not apply to this rule.
G. Executive Order 13211
This rule is not subject to Executive Order 13211, entitled Actions
Concerning Regulations that Significantly Affect Energy Supply,
Disribution, or Use (66 FR 28355, May 22, 2001) because it is not
designated as an ``economically significant'' regulatory action as
defined by Executive Order 12866 (see Unit XIII.A.), nor is it likely
to have any significant adverse effect on the supply, distribution, or
use of energy.
H. Executive Order 13045
Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997) does not apply to this rule because this action is not designated
as an ``economically significant'' regulatory action as defined by
Executive Order 12866, (see Unit XIII.A.), nor does it establish an
environmental standard, or otherwise have a disproportionate effect on
children.
I. National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 ((NTTAA), 15 U.S.C. 272 note) directs EPA to use voluntary
consensus standards in its regulatory activities unless to do so would
be inconsistent with applicable law or impractical. Voluntary consensus
standards are technical standards (e.g., materials specifications, test
methods, sampling procedures) that are developed or adopted by
voluntary consensus standards bodies. This rule does not impose any
technical standards that would require EPA to consider any voluntary
consensus standards.
J. Executive Order 12898
This rule does not have an adverse impact on the environmental and
health conditions in low-income and minority communities. Therefore,
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), the Agency does not need
to consider environmental justice-related issues.
XIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and the Comptroller General of the United
States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
List of Subjects in 40 CFR Part 155
Environmental protection, Administrative practice and procedure,
Pesticides and pests.
Dated: August 1, 2006.
Stephen L. Johnson,
Administrator.
0
Therefore, 40 CFR chapter I is amended as follows:
0
1. Part 9 is amended as follows:
PART 9--[AMENDED]
0
a. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671, 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.
0
b. In Sec. 9.1, the table is amended by revising the existing heading
for ``Registration Standards''; removing the entry under that heading;
and adding a new entry to read as follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
[[Page 45732]]
------------------------------------------------------------------------
40 CFR citation OMB control no.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Registration Standards and Registration Review
------------------------------------------------------------------------
* * * * *
Part 155............................................. 2070-0057
------------------------------------------------------------------------
* * * * *
0
2. Part 155 is amended as follows:
PART 155-REGISTRATION STANDARDS AND REGISTRATION REVIEW
0
a. The authority citation for part 155 continues to read as follows:
Authority: 7 U.S.C. 1361.
0
b. By revising the heading of part 155 to read as set forth above.
0
c. By adding a new subpart C to read as follows:
Subpart C--Registration Review Procedures
Sec.
155.40 General.
155.42 Registration review cases.
155.44 Establish schedules for registration review.
155.46 Deciding that a registration review is complete and
additional review is not needed.
155.48 Data Call-In.
155.50 Initiate a pesticide's registration review.
155.52 Stakeholder engagement.
155.53 Conduct of a pesticide's registration review.
155.56 Interim registration review decision.
155.57 Registration review decision.
155.58 Procedures for issuing a decision on a registration review
case.
Subpart C--Registration Review Procedures
Sec. 155.40 General.
(a) Purpose. These regulations establish procedures for the
registration review program required in FIFRA 3(g). Registration review
is the periodic review of a pesticide's registration to ensure that
each pesticide registration continues to satisfy the FIFRA standard for
registration. The goal of the registration review procedures is review
of each pesticide's registration every 15 years.
(1) Among other things, FIFRA requires that a pesticide generally
will not cause unreasonable adverse effects on the environment.
Registration review is intended to ensure that each pesticide's
registration is based on current scientific and other knowledge
regarding the pesticide, including its effects on human health and the
environment.
(2) If a product fails to satisfy the FIFRA standard for
registration, the product's registration may be subject to cancellation
or other remedies under FIFRA.
(b) Applicability. This subpart applies to every pesticide product
registered under FIFRA section 3 as well as all pesticide products
registered under FIFRA section 24(c). It does not apply to products
whose sale or distribution is authorized under FIFRA section 5 or
section 18.
(c) Limitations. (1) At any time, the Agency may undertake any
other review of a pesticide under FIFRA, irrespective of the
pesticide's past, ongoing, scheduled, or not yet scheduled registration
review.
(2) When the Agency determines that new data or information are
necessary for a pesticide's registration review, it will require such
data under FIFRA section 3(c)(2)(B).
Sec. 155.42 Registration review cases.
(a) Establishing registration review cases. A registration review
case will be composed of one or more active ingredients and all the
products containing such ingredient(s). The Agency may group related
active ingredients into a registration review case when the active
ingredients are so closely related in chemical structure and
toxicological profile as to allow common use of some or all required
data for hazard assessment.
(1) Existing pesticides. The Agency will assign each pesticide
registered on or before the effective date of this regulation to a
registration review case.
(2) New pesticides. The Agency will assign each pesticide
registered after the effective date of this regulation to an existing
registration review case or to a new registration review case.
(3) A pesticide product that contains multiple active ingredients
will belong to the registration review cases for each of its active
ingredients.
(b) Modifying registration review cases. New data or information
may suggest that a registration review case should be modified. The
Agency may modify a registration review case in the following ways:
(1) Add a new active ingredient to a registration review case. The
Agency may determine that a new active ingredient is chemically and
toxicologically similar to active ingredients in an existing
registration review case and should be grouped with the ingredients in
the existing registration review case.
(2) Split a registration review case into two or more registration
review cases. For example, new data or information may suggest that
active ingredients in a registration review case are not as similar as
previously believed and that they belong in two or more separate
registration review cases.
(3) Move an ingredient from one registration review case to
another. For example, new data or information might suggest that an
ingredient should not be grouped with the other ingredients in the
registration review case and that it belongs in a different
registration review case.
(4) Merge two or more registration review cases into a single
registration review case. For example, new data or information might
suggest that the active ingredients in two or more registration review
cases should be grouped together for registration review.
(5) Delete an active ingredient from a registration review case.
For example, the Agency will remove the ingredient from the case if the
registrations of all products containing an active ingredient in a
registration review case are canceled.
(c) Closing a registration review case. The Agency will close a
registration review case if all products in the case are canceled.
(d) Establishing a baseline date for a registration review case.
For the purpose of scheduling registration reviews, the Agency will
establish a baseline date for each registration review case. In
general, the baseline date will be the date of initial registration of
the oldest pesticide product in the case or the date of reregistration,
whichever is later. For the purpose of these procedures, the date of
reregistration is the date on which the Reregistration Eligibility
Decision or Interim Reregistration Decision was signed, whichever date
the Agency determines to be more appropriate based on the
comprehensiveness of the review.
(1) The Agency generally will not change the baseline date for a
registration review case when it modifies a case by adding or deleting
ingredients or products.
(2) When the Agency splits a registration review case into two or
more cases, the new case(s) generally will have the baseline date of
the original registration review case.
(3) When the Agency merges two or more registration review cases
into a single case, the Agency generally will use the earliest baseline
date as the baseline date for the new case.
(e) Announcing registration review cases and baseline dates. The
Agency will maintain a list of registration review cases, including
baseline dates, on its website.
[[Page 45733]]
Sec. 155.44 Establish schedules for registration review.
The Agency will develop schedules for registration review that are
generally based on the baseline date of the registration review case or
on the date of the latest registration review of the registration
review case. The Agency may also take into account other factors, such
as achieving process efficiencies by reviewing related cases together,
when developing schedules for registration review. The Agency will
maintain schedules for the current year and at least two subsequent
years on its website.
Sec. 155.46 Deciding that a registration review is complete and
additional review is not needed.
The Agency may determine that there is no need to reconsider a
previous decision that a pesticide satisfies the standard of
registration in FIFRA. In such cases, instead of establishing a
pesticide registration review case docket as described in Sec. 155.50,
the Agency may propose that, based on its determination that a
pesticide meets the FIFRA standard for registration, no further review
will be necessary. In such circumstances, the Agency will publish a
notice in the Federal Register announcing the availability of the
proposed decision and provide a comment period of at least 60 calendar
days. The Agency will publish a notice in the Federal Register
announcing the availability of a final version of the decision, an
explanation of any changes to the proposed decision and its response to
any comments. The date of the final notice of availability would be
used as the date of the latest registration review for the purpose of
scheduling subsequent registration reviews.
Sec. 155.48 Data Call-In.
The Agency may issue a Data Call-In notice under FIFRA section
3(c)(2)(B) at any time if the Agency believes that the data are needed
to conduct the registration review. The provisions in FIFRA section
3(c)(1), (c)(2)(B), and (c)(2)(D) apply to the submission,
compensation, and exemption of data required to conduct a registration
review.
Sec. 155.50 Initiate a pesticide's registration review.
The Agency will initiate a pesticide's registration review by
establishing a docket for each registration review case, except for
cases covered under Sec. 155.46, and opening it for public review.
(a) Contents of the registration review case docket. The Agency
will place in this docket information that will assist the public in
understanding the types of information and issues that the Agency may
consider in the course of the registration review. The Agency may
include information from its files including, but not limited to, the
following information:
(1) An overview of registration review case status;
(2) A list of current registrations and registrants, any Federal
Register notices regarding pending registration actions, and current or
pending tolerances;
(3) Risk assessment documents;
(4) Bibliographies concerning current registrations;
(5) Summaries of incident data; and
(6) Any other pertinent data or information.
(b) Public review of the registration review case docket. The
Agency will publish a notice in the Federal Register announcing the
availability for public review of the information described in
paragraph (a) of this section and establishing a comment period of at
least 60 days. During this comment period, interested persons may
identify any additional information they believe the Agency should
consider in the course of the registration review.
(c) Submission of data and other information during the comment
period. The Agency may identify, either in the notice published under
paragraph (b) of this section, or at any other time, data or
information that it does not have but which may be useful, if
available, for consideration in the registration review. Any person may
submit data or information in response to such identification. In order
to be considered during a pesticide's registration review, the
submitted data or information must meet the requirements listed below.
(1) In order to ensure that the Agency will consider data or
information in the conduct of a registration review, interested persons
must submit the data or information during the comment period
established in the notice described in paragraph (b) of this section.
The Agency may, at its discretion, consider data or information
submitted at a later date.
(2) The data or information must be presented in a legible and
useable form. For example, an English translation must accompany any
material that is not in English and a written transcript must accompany
any information submitted as an audiographic or videographic record.
Written material may be submitted in paper or electronic form.
(3) Submitters must clearly identify the source of any submitted
data or information.
(4) Submitters may request the Agency to reconsider data or
information that the Agency rejected in a previous review. However,
submitters must explain why they believe the Agency should reconsider
the data or information in the pesticide's registration review.
(d) For the purposes of this subpart, the provisions of subpart B
do not apply.
Sec. 155.52 Stakeholder engagement.
In addition to the public participation opportunities described in
Sec. 155.50 and Sec. 155.53(c), the Agency may meet with stakeholders
regarding a forthcoming or ongoing registration review. For example,
before conducting a pesticide's registration review, the Agency may
consult with registrants or pesticide users regarding the use and usage
of the pesticide. The Agency may consult with registrants, pesticide
users, or other persons during a pesticide's registration review with
regard to developing risk management options for a pesticide. The
Agency may informally consult with officials of Federal, State or
Tribal agencies regarding a forthcoming or ongoing registration review.
(a) Minutes of meetings with persons outside of government. The
Agency will place in the docket minutes of meetings with persons
outside of government where the primary purpose of the meeting is to
discuss a forthcoming or ongoing registration review. The Agency will
place minutes of such meetings in the docket when it takes action under
Sec. 155.58. At its discretion, the Agency may place minutes of such
meetings in the docket sooner.
(b) Exchange of documents or other written material. In the course
of a meeting with a person outside of government, the Agency or that
person may provide the other with a copy of a document or other written
material that has not yet been released to the public. The Agency will
place a copy of any such document or other written material in the
docket along with the minutes of the meeting where the materials were
exchanged.
(c) Confidential business information. The Agency will not place
confidential business information in the docket.
Sec. 155.53 Conduct of a pesticide's registration review.
The Agency will review data and information described in Sec.
155.50(a), (b), and (c) or submitted in response to a Data Call-In
notice that it believes should be considered in the pesticide's
registration review.
(a) Assess changes since a pesticide's last review. The Agency will
assess any changes that may have occurred since the Agency's last
registration decision in order to determine the significance of
[[Page 45734]]
such changes and whether the pesticide still satisfies the FIFRA
standard for registration. The Agency will consider whether to conduct
a new risk assessment to take into account, among other things, any
changes in statutes or regulations, policy, risk assessment procedures
or methods, or data requirements. The Agency will consider whether any
new data or information on the pesticide, including any data or
information submitted under Sec. 155.50 or in response to a Data Call-
In notice, warrant conducting a new risk assessment or a new risk/
benefit assessment. The Agency will also consider whether any new data
or information regarding an individual pesticide product, including any
data or information submitted under Sec. 155.50 or in response to a
Data Call-In notice, such as data or information about an inert
ingredient in the pesticide product or other information or data
relating to the composition, labeling or use of the pesticide product,
warrant additional review of a pesticide product's registration.
(b) Conduct new assessments as needed. (1) Active ingredient(s) in
the registration review case. If the Agency finds that a new assessment
of the pesticide is needed, it will determine whether it can base the
new assessment on available data or information, including data or
information submitted under Sec. 155.50 or in response to a Data Call-
In notice. If sufficient data or information are available, the Agency
will conduct the new risk assessment or risk/benefit assessment. If the
Agency determines that additional data or information are needed to
conduct the review, the Agency will issue a Data Call-In notice under
FIFRA section 3(c)(2)(B).
(2) Individual product registrations. If the Agency finds that
additional review of an individual product's registration is needed, it
will review the pesticide product label, confidential statement of
formula, product-specific data, or other pertinent data or information,
as appropriate, to determine whether the registration of the individual
product meets the FIFRA standard for registration. If the Agency
determines that additional data or information are needed to conduct
the review, the Agency will issue a Data Call-In notice under FIFRA
section 3(c)(2)(B).
(c) Public participation during a pesticide's registration review.
The Agency will generally make available for public review and comment
a draft risk assessment for a pesticide if a new risk assessment has
been conducted. The Agency will publish a notice in the Federal
Register announcing the availability of the draft risk assessment and
provide a comment period of at least 30 calendar days. The Agency will
publish a notice in the Federal Register announcing the availability of
a revised risk assessment, an explanation of any changes to the
proposed document, and its response to comments. If the revised risk
assessment indicates risks of concern, the Agency may, in the notice
announcing the availability of the revised risk assessment, provide a
comment period of at least 30 calendar days for the public to submit
suggestions for mitigating the risk identified in the revised risk
assessment.
(1) The Agency might not request comments on a draft risk
assessment in cases where the Agency's initial screening of a pesticide
indicates that it has low use/usage, affects few if any stakeholders or
members of the public, poses low risk, and/or requires little or no
risk mitigation. In such cases, the Agency will make a draft risk
assessment available for public review and comment when it issues a
proposed decision on the registration review case.
(2) If the Agency finds that it is not necessary to conduct a new
risk assessment, it will issue a proposed decision on the registration
review case as described in Sec. 155.58.
Sec. 155.56 Interim registration review decision.
The Agency may issue, when it determines it to be appropriate, an
interim registration review decision before completing a registration
review. Among other things, the interim registration review decision
may require new risk mitigation measures, impose interim risk
mitigation measures, identify data or information required to complete
the review, and include schedules for submitting the required data,
conducting the new risk assessment and completing the registration
review. A FIFRA 3(c)(2)(B) notice requiring the needed data or
information may precede, accompany, or follow issuance of the interim
registration review decision. The Agency will follow procedures in
Sec. 155.58 when issuing an interim registration review decision.
Sec. 155.57 Registration review decision.
A registration review decision is the Agency's determination
whether a pesticide meets, or does not meet, the standard for
registration in FIFRA.
Sec. 155.58 Procedures for issuing a decision on a registration
review case.
(a) The Agency will publish a notice in the Federal Register
announcing the availability of a proposed registration review decision
or a proposed interim registration review decision. At that time, the
Agency will place in the pesticide's registration review docket the
Agency's proposed decision and the bases for the decision. There will
be a comment period of at least 60 calendar days on the proposed
decision.
(b) In its proposed decision, the Agency will, among other things:
(1) State its proposed findings with respect to the FIFRA standard
for registration and describe the basis for such proposed findings.
(2) Identify proposed risk mitigation measures or other remedies as
needed and describe the basis for such proposed requirements.
(3) State whether it believes that additional data are needed and,
if so, describe what is needed. A FIFRA 3(c)(2)(B) notice requiring
such data may be issued in conjunction with a proposed or final
decision on the registration review case or a proposed or final interim
decision on a registration review case.
(4) Specify proposed labeling changes; and
(5) Identify deadlines that it intends to set for completing any
required actions.
(c) After considering any comments on the proposed decision, the
Agency will issue a registration review decision or interim
registration review decision. This decision will include an explanation
of any changes to the proposed decision and the Agency's response to
significant comments. The Agency will publish a notice in the Federal
Register announcing the availability of a registration review decision
or interim registration review decision. The registration review case
docket will remain open until all actions required in the final
decision on the registration review case have been completed.
(d) If the registrant fails to take the action required in a
registration review decision or interim registration review decision,
the Agency may take appropriate action under FIFRA.
[FR Doc. E6-12904 Filed 8-8-06; 8:45 am]
BILLING CODE 6560-50-S
| File Type | application/msword |
| File Title | Attachment C |
| Author | CSMOOT |
| Last Modified By | CSMOOT |
| File Modified | 2008-04-14 |
| File Created | 2008-04-14 |