[Federal Register Volume 75, Number 214 (Friday, November 5, 2010)]
[Proposed Rules]
[Pages 68297-68305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27906]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 152
[EPA-HQ-OPP-2009-0456; FRL-8424-8]
RIN 2070-AJ58
Pesticides; Satisfaction of Data Requirements; Procedures To
Ensure Protection of Data Submitters' Rights
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to revise its regulations governing procedures
for the satisfaction of data requirements under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). These provisions
include, among other things, procedures for the protection of exclusive
use and data compensation rights of data submitters. The proposed
revisions would update the regulations, which have not been revised
since issuance in 1984, to accommodate statutory and procedural changes
that have occurred since that time. The revisions would also make minor
changes to clarify the regulations. The revisions would simplify the
procedures and reduce burdens for certain data submitters.
DATES: Comments must be received on or before January 4, 2011.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2009-0456, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2009-0456. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available
[[Page 68298]]
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 OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., 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: Cameo G. Smoot, Field and External
Affairs Division, Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-5454; 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 produce
pesticide products that require registration with EPA (NAICS code
32532).
This listing is not all-inclusive, 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. 152.81 of the regulatory text. 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. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. Statutory Authority
Under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), 7 U.S.C. 136 et seq., EPA regulates the sale, distribution and
use of pesticides, and the allowable levels of such pesticides in or on
food under the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C.
346a. EPA regulations covering activities under these statutes are
located in 40 CFR parts 150-180.
The process of registering a pesticide begins with submission to
EPA of an application package and required data. In reviewing
applications for pesticide product registration under FIFRA, EPA must
determine, among other things, whether the pesticide generally causes
unreasonable adverse effects on the environment when used in accordance
with widespread and commonly recognized practice. If EPA determines
that a pesticide product meets the registration standard of FIFRA
section 3(c), EPA registers (or licenses) the product for distribution
and sale in the United States (U.S.). Pesticides must be registered or
exempted by EPA's Office of Pesticide Programs before they may be sold
or distributed in the U.S. Once registered, a pesticide may not legally
be used unless the use is consistent with the approved directions for
use on the pesticide's label or labeling.
B. Data Requirements
FIFRA section 3(c)(2) directs EPA to publish guidelines specifying
the kinds of data that applicants and registrants must submit to
support EPA regulatory determinations under FIFRA. These data
requirements are set forth in 40 CFR part 158 and 40 CFR part 161. The
data allow EPA to evaluate whether a pesticide has the potential to
cause harmful effects on certain nontarget organisms and endangered
species that include: Humans; wildlife; plants; and surface water or
ground water.
C. Satisfaction of Data Requirements
EPA regulations in 40 CFR part 152, subpart E prescribe a variety
of means by which applicants may satisfy EPA's data requirements. These
include submitting new studies, but they also allow an applicant to
cite to data previously submitted by another person that are relevant
to that applicant's product. When the latter option is selected, an
applicant may be required to either obtain permission or offer
compensation to cite the data, depending upon whether the data at issue
are subject to the exclusive use or data compensation provisions of
FIFRA section 3(c)(1)(F). In addition, the regulations in 40 CFR part
152, subpart E spell out the circumstances under which certain
applicants are exempt from data submission or citation obligations
(i.e., the formulators' exemption provided by FIFRA section
3(c)(2)(D)).
D. Protection of Data Submitters' Rights
The bulk of the regulations in 40 CFR part 152, subpart E address
those situations in which applicants for registration choose to satisfy
data requirements by citation to existing data submitted by other
persons. In that respect, the regulations prescribe:
1. The means by which a pesticide data submitter can protect and
document his/her exclusive use and compensation rights in data
submitted to the Agency. Generally, persons submitting data must
request inclusion on an Agency-maintained Data Submitters List as the
means for
[[Page 68299]]
asserting their rights to offers of compensation from applicants who
cite their data.
2. Procedures that applicants who cite to data submitted by others
must follow to ensure that data submitters' rights are protected. The
procedures apply to new and amended registrations, as well as
maintenance of existing registrations under the reregistration and
registration review programs.
3. Procedures for the transfer of data rights to other persons.
Data rights are separate from the registration of the pesticide, and
therefore may be transferred to another person separate from the
registration.
4. The procedures that a data submitter may use to seek redress
when the submitter believes he/she has been deprived of data rights
accorded under FIFRA.
III. Today's Proposed Revisions
EPA is proposing to update certain aspects of 40 CFR part 152,
subpart E regulations governing satisfaction of data requirements and
the associated data rights procedures. The regulations were promulgated
in 1984 and have served satisfactorily since then. EPA has, however,
identified the need to update the provisions to reflect changes in the
statute and related practices over time. For example, the scope of the
protections has expanded by statute to include both new protections and
new decisions that are subject to data rights protection procedures,
including reregistration under FIFRA section 4, and registration review
under FIFRA section 3(g). In addition, EPA's needs and practices have
changed.
A. Applicability (40 CFR 152.81 and 40 CFR 152.46)
EPA proposes to replace the limited listing of actions to which the
subpart does not apply (excepted actions) with a single reference to
actions that may be accomplished by notification or non-notification
under 40 CFR 152.46. EPA's intention is first to simplify the exception
provisions. At the same time, however, the revision highlights the
underlying principle that an action that does not require scientific
review of data also does not require satisfaction of data requirements,
and is not subject to the requirements in 40 CFR part 152, subpart E.
While the current regulation contains this proviso in 40 CFR
152.81(b)(4)(xvi), the proposed revision gives prominence to this
fundamental precept, and provides a firm basis for future
determinations of the applicability of 40 CFR part 152, subpart E to
specific actions.
1. Applicability (40 CFR 152.81). 40 CFR 152.81 describes the
applicability of the provisions of subpart E to applications of various
types, and more important to today's proposal, those actions to which
the procedures do not apply. Some actions are not covered by the
provisions of FIFRA section 3(c)(1)(F), including actions such as
emergency exemptions under FIFRA section 18, experimental use permits
under FIFRA section 5, and State registrations under FIFRA section
24(c). These exceptions would not change.
However, the bulk of the exceptions listed in current 40 CFR
152.81(b) rely not on statutory exceptions, but on the principle that
if EPA does not need to review scientific data in order to make its
regulatory determinations, it need not require that applicants address
the satisfaction of data requirements at all. Accordingly, current 40
CFR 152.81(b) identifies a detailed set of amendments to registration
that do not require review of scientific data. These include, among
other things, minor amendments to composition and labeling, deletion of
uses, clarifications of labeling content and presentation, and other
actions of an essentially administrative nature. The list was not
intended to be all-inclusive when promulgated, and is in fact only
illustrative, given the wide variety of possible revisions to
registration. EPA reserved the right to make determinations on the need
for scientific data on a case-by-case basis, and either to require the
procedures if scientific data are needed, or excuse the applicant from
the procedures if scientific data are not needed (see 40 CFR
152.81(b)(4) and 40 CFR 152.81(b)(4)(xvi) respectively).
2. Notifications and non-notifications (40 CFR 152.46). In a major
restructuring of its procedural regulations in 1988, EPA introduced the
concept of revisions to registration that could be accomplished by
notification (40 CFR 152.46(a)) or non-notification (40 CFR 152.46(b)).
Further, in 1996, those regulations were amended (61 FR 33039, June 26,
1996) (FRL-5372-8) to permit the Agency to issue procedures (generally
issued using Pesticide Registration (PR) Notices) to implement actions
by notification or non-notification.
The notification and non-notification processes are intended to
provide a streamlined means for registrants to make registration
changes that have no potential to cause adverse effects. As the terms
suggest, changes identified in these procedures may be accomplished
without the need for Agency approval. EPA regards an action that will
``have no potential to cause unreasonable adverse effects'' as used in
40 CFR 152.46 as equivalent to a determination that no scientific data
are needed to make the change within the meaning of 40 CFR
152.81(b)(4)(xvi). In the latest PR Notice that addresses revisions
that may be made by notification and non-notification (i.e., PR Notice
98-10, October 22, 1998), EPA expanded the list of eligible actions
considerably. Note that EPA has also permitted certain specific
labeling changes to be made through notification or non-notification in
other PR Notices (see, e.g., PR Notices 2007-1 and 2008-1) and in case-
by-case registration actions.
3. Comparison of actions (40 CFR 152.81 and 40 CFR 152.46). EPA has
reviewed the list of actions in 40 CFR 152.81(b)(4) against those
permitted by notification or non-notification under 40 CFR 152.46, as
expressed in PR Notice 98-10, to determine whether the changes are
comparable. PR Notice 98-10 represents an additional 14 years of
evolving Agency regulations and policy from the 1984 promulgation of 40
CFR 152.81, and is considerably more detailed in its description of
actions. Thus comparisons between the two are not exact.
In a number of cases, the types of amendments excepted under 40 CFR
152.81(b)(4) are covered by the provisions of 40 CFR 152.46, as
expressed in PR Notice 98-10, and thus the proposed revision would have
no effect on applications of those amendments (for example, minor
changes in labeling having no substantive impact). In other cases,
statutory, regulatory and policy changes since 1984 have resulted in
excepted actions no longer being eligible for exception under 40 CFR
152.81(b). For example, addition or deletion of an active ingredient is
now generally regarded as a new formulation requiring new registration.
Finally, some types of excepted actions have been rendered moot as they
are no longer treated as ``applications'' for the purposes of subpart
E, and are governed by other regulations (e.g., supplemental
distribution, name and address changes, label splitting for marketing
purposes).
EPA regards the determinations under 40 CFR 152.46, as expressed in
PR Notice 98-10 and in other notices implementing notification or non-
notification procedures, as the Agency's written finding under 40 CFR
152.81(b)(4) as to whether scientific data (and thus compliance with
subpart E) are required to evaluate an application. Today's proposal
simply articulates this principle in the text of the regulations.
EPA will generally make these determinations in connection with its
[[Page 68300]]
review of applications. However, applicants and registrants may seek
EPA's determination as to whether subpart E procedures will apply to
their actions in advance of submission of their applications.
The proposed revision would broadly apply to future actions that
EPA determines can be implemented through notification or non-
notification procedures. Changes to the actions permitted by
notification or non-notification in the future may change the
applicability of the procedures in subpart E. Excepted actions not
addressed specifically in the regulation or that are not subject to
notification and non-notification procedures would continue to be
subject to subpart E unless EPA determines, on a case-by-case basis,
that such actions do not require scientific review of data.
Accordingly, EPA proposes to eliminate the limited listing in 40
CFR 152.81 in favor of a reference to any action that may be
implemented by the notification or non-notification procedures under 40
CFR 152.46.
B. Update Definition of Exclusive Use Study (40 CFR 152.83)
EPA proposes to update and restructure the existing definition of
``exclusive use study'' to incorporate the additional exclusive use
criteria added by the Food Quality Protection Act (1996). In that act,
Congress expanded the exclusive use provisions of FIFRA section
3(c)(1)(F) in two circumstances:
1. Congress amended section 3(c)(1)(F)(ii) to allow for the
extension of an original 10-year exclusive use provision for a period
of up to an additional 3 years when the registrant adds minor uses
meeting certain criteria to the original registration for which the
exclusive use data were submitted.
2. Congress added a new section 3(c)(1)(F)(vi) that creates
exclusive use rights in data submitted by an applicant or registrant to
support an amendment adding a new use to an existing registration that
does not retain any period of exclusive use, provided such data relate
solely to a minor use of a pesticide. These provisions would be
incorporated into the new definition.
Because of the complexity of the new definition of exclusive use,
EPA proposes to create a separate provision in the regulation to define
``exclusive use study.'' To do so, EPA proposes to move the existing
definitions from 40 CFR 152.83 into 40 CFR 152.82, and to add a new 40
CFR 152.83.
C. When Materials Must Be Submitted (40 CFR 152.84)
EPA proposes to revise 40 CFR 152.84 to conform to the requirements
of FIFRA section 33(f)(4) (as amended by the Pesticide Registration
Improvement Renewal Act, Public Law 110-94, commonly called PRIA II).
Current 40 CFR 152.84 allows an applicant to submit required
documents, forms, and other materials related to satisfaction of data
requirements at any time before the Agency approves the application,
although it recommends submission at the time of application. Some of
the required information must be submitted with the application, e.g.,
a request for waiver of a data requirement, because the Agency must
make a determination as part of its review process. Other information
has routinely been provided on forms supplied by the Agency, such as
the Formulators' Exemption Statement or the General Offer to Pay
Statement, and typically is submitted with the application.
Under FIFRA section 33(f)(4)(B), EPA must determine during the
initial screen (within 21 days after receiving an application and the
required registration service fee) that ``the application contains all
the necessary forms, data, and draft labeling, formatted in accordance
with guidance published by the Administrator.'' Information and forms
required by subpart E pertaining to satisfaction of data requirements
are covered by this provision. Furthermore, the Agency must reject
applications that do not pass the initial 21-day content screen.
Accordingly, the information and forms required by subpart E are no
longer permitted to be submitted at any time prior to approval of the
application, but must be submitted at the time of application.
In addition to the above reasons, EPA believes that the primary
rationale for the provision of 40 CFR 152.84 that allows applicants to
satisfy subpart E requirements after submission of an application no
longer exists. In the preamble to the existing regulations (49 FR
30884, at 30897, August 1, 1984), EPA identified the 60-day waiting
period for data gap certification letters as the primary example of
time-consuming activities that could unduly delay the submission of an
application were applicants are required to submit completed subpart E
materials at the time of submission of their applications. Because this
proposed regulation will eliminate the requirement for applicants to
send data gap letters in order to claim a data gap under the selective
method of data support (see Unit III.G.), EPA sees no compelling reason
for maintaining the existing provision even in the absence of the
requirements of PRIA II.
Accordingly, EPA proposes to revise 40 CFR 152.84 to specify that
the necessary forms and information pertaining to satisfaction of data
requirements must be submitted at the time of application.
D. Addition of Electronic Means of Contacting Data Submitters (40 CFR
152.86 and 40 CFR 152.95)
EPA proposes to revise 40 CFR 152.86 and 40 CFR 152.95 to include
the use of electronic methods of communication, such as e-mail, in
addition to regular mail. This change would update communication
methods between applicants.
E. Selective Method (40 CFR 152.90)
EPA proposes to eliminate the requirement that applicants use a
Registration Standard as the default source of the listing of data
requirements under the selective method in 40 CFR 152.90.
Under the provisions of subpart E, an applicant may choose between
two methods to address data compensation for cited data: Cite-all or
selective. The cite-all method (40 CFR 152.86) permits an applicant to
cite collectively all data in the Agency's files that might pertain to
his/her product, provided, among other things, the applicant certifies
that he/she has obtained the original data submitter's permission to
cite any exclusive use data for the chemical, makes an offer to pay
each person listed on the Data Submitters List for each active
ingredient in his/her product and makes a general offer to pay other
persons to the extent required by FIFRA section 3(c)(1)(F). The cite-
all method, while easier to use and less burdensome procedurally,
potentially subjects the applicant to an unknown or uncertain
compensation liability.
In contrast, under the selective method (40 CFR 152.90), an
applicant must provide a list of data requirements that would apply to
his/her product if it were being proposed for registration under FIFRA
section 3(c)(5) for the first time, and must choose an acceptable
method of satisfying each data requirement individually. If the
applicant chooses to cite to existing data to satisfy an individual
requirement, the applicant will need the permission of the original
data submitter if the data are entitled to exclusive use treatment
under FIFRA, or will need to make an offer to pay compensation to the
original data submitter if the data are subject to the compensation
provisions of FIFRA.
[[Page 68301]]
Because this method allows the applicant to select the data to be
relied upon to meet EPA data requirements, the applicant under the
selective method may thereby limit the scope of the required offers to
pay.
Currently, 40 CFR 152.90(a) requires that an applicant use an
issued Registration Standard (the EPA reregistration decision documents
issued prior to 1988) as the source of his/her list of data
requirements for the selective method. If the Registration Standard
does not address all required data or there is no Registration
Standard, the applicant must refer to 40 CFR part 158 data requirements
as the alternate source of his/her list of data requirements.
The form of EPA decision documents has evolved since the 1984
regulations were promulgated. Registration Standards were superseded
beginning in 1988 by Reregistration Eligibility Decision documents
(REDs) as the Agency implemented the reregistration requirements of
FIFRA section 4. In turn, REDs will likely be superseded or updated by
determinations made under the new Registration Review program required
by FIFRA section 3(g) and 40 CFR part 155. Given the growth and
evolution of the program's systematic review of existing pesticides,
EPA believes it should no longer identify by regulation a specific type
of decision document as the source of data requirement listings. These
documents are a snapshot of the data requirements at a particular
review period, and are likely to become outdated over time as EPA's
risk assessments evolve and new types of data are needed.
EPA also notes that on October 26, 2007 ((72 FR 60934) (FRL-8106-
5); (72 FR 60988) (FRL-8109-8)), EPA significantly amended its data
requirements in 40 CFR part 158 for conventional, biochemical and
microbial pesticides. 40 CFR part 158 and 40 CFR part 161 represent the
most up-to-date iteration of data requirements for pesticides, and are
likely to be updated in the future when appropriate to meet changing
data needs. For example, EPA proposed revisions to the data
requirements for antimicrobial pesticides (73 FR 59381, October 8,
2008), and other amendments are under development. In general, EPA
believes that the regulations in 40 CFR part 158 and 40 CFR part 161
should be the primary source of the data listings needed for the
selective method.
Thus, EPA proposes to remove from 40 CFR 152.90 the requirement
that any specific Agency listing of data requirements serve as the
basis for the selective method listing. Instead, EPA would refer
applicants to the data requirements in 40 CFR part 158 and 40 CFR part
161.
Notwithstanding, consideration of existing decision documents such
as REDs will continue to provide useful guidance to applicants and
registrants in determining how EPA has applied the data requirements to
individual products and uses. However, such documents do not represent
a binding Agency determination regarding the data requirements that
must be fulfilled to satisfy the requirements of any individual
registration.
F. Data Waivers (40 CFR 152.91)
EPA proposes to make minor revisions in the data waiver provisions
in the selective method in 40 CFR 152.91 to conform to current policy
concerning waivers, and to update them to accommodate Reregistration
and Registration Review programs.
When the regulations were initially promulgated, the Agency's
program for the systematic review and maintenance of existing
registration was called the Registration Standards program, and the
program had not fully matured. EPA anticipated that data waivers would
be evaluated, granted and documented in the context of that program. 40
CFR 152.91 allows an applicant to rely on a previously granted waiver
that has been documented in a Registration Standard.
As indicated previously, the Registration Standards program was
replaced in 1988 by the reregistration program mandated by FIFRA
section 4, which, in turn will be succeeded by the Registration Review
program. These second- and third-generation pesticide review programs
use different terminology for the decision documents that result.
Applicants may rely on these later program documents to identify and
document an existing waiver.
Accordingly, EPA proposes to add Reregistration Eligibility and
Registration Review decision documents as additional Agency records
that applicants may refer to. This revision does not change the
substance of the provision, as the current listing of applicable
documents is merely illustrative.
EPA also proposes to specify that a denial of a waiver decision is
a final Agency action. Similar language is already included in the
Agency's regulations on waivers found in 40 CFR 158.45, and this
proposal would simply modify 40 CFR 152.91 to reflect the Agency's
existing position.
G. Elimination of Certification and Documentation Procedures for Data
Gaps (40 CFR 152.96)
As touched upon in Unit III.E., when the regulations were initially
promulgated in 1984, EPA was in the midst of establishing procedures
for the review of existing registrations. The purpose of reregistration
was to update and modernize the scientific database supporting
pesticide registrations. At the time, EPA was also on the verge of
promulgating for the first time the data requirements supporting
registration. Shortly after subpart E was promulgated in August 1984,
EPA promulgated a final rule on data requirements (October 24, 1984; 49
FR 42881) (FRL-2591-5).
In acknowledgement of the fact that many of these data requirements
were to be satisfied during the reregistration process, the data
compensation provisions of subpart E explicitly provide a procedure to
satisfy a data requirement for which data have not yet been submitted--
the data gap procedures in 40 CFR 152.96. In essence, an applicant can
satisfy a data requirement by documenting that no data have been
submitted to fulfill the data requirement. The applicant does so by
writing to data submitters and requesting verification that they have
not submitted data to satisfy the data requirement. Data submitters are
not required to respond to such requests, but lose the right to later
challenge the applicant's data gap claim if they do not respond.
As noted, however, the processes for review of existing pesticides
have evolved significantly over the years, and most data gaps have been
eliminated by the submission of data under the reregistration program.
Few, if any, applicants can legitimately claim a data gap for a
pesticide that has undergone reregistration. The absence or
availability of data is evident because the data are likely to be
listed in an Agency decision document such as a RED. Moreover, in EPA's
experience, the data gap procedures are rarely used, even when data
gaps were much more common.
Although there may be circumstances when an applicant may
legitimately claim that a data gap exists, EPA believes the required
data gap documentation process is no longer needed because: (1) As
noted above, most data gaps have been eliminated; and (2) EPA is in a
much better position today to evaluate the legitimacy of data gap
claims because of its reregistration program. Consequently, EPA
proposes to eliminate 40 CFR 152.96(b) and 40 CFR 152.96(c).
[[Page 68302]]
EPA will continue to allow a claim of a data gap to satisfy an
initial screen of an application, but will not require the submission
of the certification of data gap procedures. EPA will also scrutinize
such claims carefully, as it believes that few such claims can be
supported given the significant amounts of data now available for most
pesticides. EPA's current regulations in 40 CFR 152.115(a) provide that
any data requirement that remains legitimately unfulfilled at the time
of registration is established as a condition of the registration under
FIFRA section 3(c)(7), and the new registrant is required to fulfill
the data requirement whenever existing registrants of similar products
must do so.
Under the proposed rule, a data submitter would no longer routinely
receive requests from applicants to confirm a data gap. However, under
40 CFR 152.119, EPA will make available 30 days after registration the
means by which an applicant satisfied the data requirements, including
whether, under the selective method, the applicant claimed a data gap.
A registrant thus has the means to ascertain whether he/she has
submitted data that might fulfill a data requirement for which the
applicant has claimed a data gap exists.
Since EPA would no longer require the data gap procedures, EPA also
proposes to revise the petition procedures in 40 CFR 152.99 such that a
data submitter may petition for redress on the basis of a false or
improper data gap claim rather than failure to comply with the data gap
procedures. EPA also proposes to eliminate 40 CFR 152.97(b) (Obligation
to respond to data gap letters) since that provision will serve no
purpose with the elimination of the data gap letter procedure as
proposed today.
IV. FIFRA Mandated Reviews
In accordance with FIFRA sections 25(a) and (d), the Agency
submitted a draft of this proposed rule to the Committee on Agriculture
in the United States House of Representatives, the Committee on
Agriculture, Nutrition, and Forestry in the United States Senate, the
Secretary of Agriculture, and the FIFRA Scientific Advisory Panel
(SAP). The SAP and the Secretary of Agriculture waived review of this
proposed rule.
V. Statutory and Executive Order Reviews
A. Regulatory Review
This action is not a ``significant'' regulatory action under the
terms of Executive Order 12866 entitled Regulatory Planning and Review
(58 FR 51735, October 4, 1993), and is therefore not subject to review
by the Office of Management and Budget (OMB) under Executive Order
12866.
B. Paperwork Reduction Act
The information collection activities related to the submission of
data to EPA in order to register a pesticide product are already
approved by OMB under the Paperwork Reduction Act (PRA) 44 U.S.C. 3501
et seq. This action does not impose any new information collection
burden. The information collection requirements, i.e., the paperwork
collection activities, contained in this proposal are already approved
by OMB under the following information collection requests (ICRs):
1. The activities associated with the application for a new or
amended registration of a pesticide are currently approved under OMB
Control No. 2070-0060 (EPA ICR No. 0277).
2. The activities associated with the generation of data for the
Pesticide Data Call-In Program are currently approved under OMB Control
No. 2070-0174 (EPA ICR No. 2288.01).
Copies of these OMB-approved ICRs may be obtained from Susan Aby,
Collection Strategies Division; U.S. Environmental Protection Agency
(2822T); 1200 Pennsylvania Ave., NW., Washington, DC 20460; or by
calling (202) 566-1672.
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. An agency may not conduct or sponsor, and a person is not
required to respond to an information collection request unless it
displays a currently valid OMB control number, or is otherwise required
to submit the specific information by a statute. The OMB control
numbers for EPA's regulations, after appearing in the preamble of the
final rule, are listed in 40 CFR part 9 and 48 CFR chapter 15, and
included on the related collection instrument (e.g., form or survey).
EPA has determined that this proposed rule imposes no additional
information collection and paperwork burden.
These existing ICRs cover the paperwork activities contained in
this proposal because these activities already occur as part of
existing program activities.
These program activities are an integral part of the Agency
pesticide program and the corresponding ICRs are regularly renewed. The
total estimated average annual public reporting burden currently
approved by OMB for these various activities ranges from 8 hours to
approximately 3,000 hours per respondent, depending on the activity and
other factors surrounding the particular pesticide product.
Comments are requested on the Agency's need for this information,
the accuracy of the burden estimates, and any suggested methods for
minimizing respondent burden, including the use of automated collection
techniques. Send comments to EPA as part of your overall comments on
this proposed action in the manner specified in Unit I. In the final
rule, the Agency will address any comments received regarding the
information collection requirements contained in this proposal.
B. Regulatory Flexibility Act
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA),
5 U.S.C. 601 et seq., after considering the potential economic impacts
of this proposed rule on small entities, the Agency hereby certifies
that this action will not have a significant adverse economic impact on
a substantial number of small entities.
Small entities include small businesses, small organizations, and
small governmental jurisdictions. For purposes of assessing the impacts
of today's proposed rule on small entities, a small entity is defined
as: (1) A small business as defined by the Small Business
Administration's (SBA) regulations at 13 CFR 121.201; (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.
This action will not have a significant economic impact on a
substantial number of small entities. In determining whether a rule has
a significant economic impact on a substantial number of small
entities, the impact of concern is any significant adverse economic
impact on small entities, since the primary purpose of the
[[Page 68303]]
regulatory flexibility analyses is to identify and address regulatory
alternatives ``which minimize any significant economic impact of the
rule on small entities.'' 5 U.S.C. 603 and 604. Thus, an agency may
certify that a rule will not have a significant economic impact on a
substantial number of small entities if the rule relieves regulatory
burden, or otherwise has a positive economic effect on all of the small
entities subject to the rule.
EPA believes that this proposed rule would not have any adverse
impacts on affected small entities, because it does not alter the scope
of existing pesticide data submission or citation obligations. Further,
small business entities already receive the benefit of the statutory
``formulators' exemption'' provision which exempts qualifying
applicants and registrants from most data submission and citation
obligations. No changes to this provision are proposed in this action.
The proposed changes discussed in this document are expected to
simplify the procedures and reduce burdens on certain data submitters.
EPA has therefore concluded that this proposed rule will not have any
adverse impacts on affected small entities. Of course EPA continues to
be interested in the potential impacts of the procedures on small
entities and welcome comments on issues related to such impacts.
D. Unfunded Mandates Reform Act
This action does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) Public Law 104-4. Therefore, this action is
not subject to the requirements of UMRA.
E. Federalism
Pursuant to Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999), EPA has determined that this proposed 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 proposed rule.
F. Tribal Implications
Under Executive Order 13175, entitled Consultation and Coordination
with Indian Tribal Governments (65 FR 67249, November 6, 2000), EPA has
determined that this proposed rule does not have tribal implications
because it will not have any effect 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 proposed rule.
G. Children's Health Protection
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 proposed rule because this action is not
designated as an ``economically significant'' regulatory action as
defined by Executive Order 12866 (see Unit V.A.), nor does this action
establish an environmental standard that is intended to have a
disproportionate effect on children.
H. Energy Effects
This proposed rule is not subject to Executive Order 13211,
entitled Actions Concerning Regulations that Significantly Affect
Energy Supply Distribution, or Use (66 FR 28355, May 22, 2001), because
this action is not expected to affect energy supply, distribution, or
use.
I. Technology Standards
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, 12(d) (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
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards.
This proposed regulation does not involve technical standards.
Therefore, EPA is not considering the use of any voluntary consensus
standards.
J. Environmental Justice
This proposed rule does not involve special considerations of any
environmental justice related issues as delineated by Executive Order
12898, entitled Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations (59 FR 7629, February
16, 1994).
List of Subjects in 40 CFR Part 152
Environmental protection, Administrative practice and procedure,
Pesticides and pests, Reporting and recordkeeping requirements.
Dated: October 18, 2010.
Lisa P. Jackson,
Administrator.
Therefore, it is proposed that 40 CFR part 152, subpart E, would be
amended as follows:
1. The authority citation for part 152 continues to read as
follows:
Authority: 7 U.S.C. 136-136y; subpart U is also issued under 31
U.S.C. 9701.
2. The title of subpart E is revised to read ``Satisfaction of Data
Requirements and Protection of Data Submitters' Rights.''
3. Section 152.81 is revised to read as follows:
Sec. 152.81 Applicability.
(a) Except as provided in paragraph (b) of this section, the
requirements of this subpart apply to:
(1) Each application for registration of a new product.
(2) Each application for amended registration of a currently
registered product.
(3) Each submission in response to a Data Call-In under FIFRA
section 3(c)(2)(B) for an existing registration, including, but not
limited to, a product subject to reregistration under FIFRA section 4
or registration review under FIFRA section 3(g). If the Data Call-In
establishes procedures for protection of data submitters' rights,
recipients must comply with the specific requirements of the Data Call-
In rather than the generic procedures set forth in Sec. Sec. 152.85
through 152.96.
(b) This subpart E does not apply to any of the following:
(1) An application for registration submitted to a State under
FIFRA section 24(c).
(2) An application for an experimental use permit under FIFRA
section 5.
(3) An application for an emergency exemption under FIFRA section
18.
(4) A request for cancellation of a registration, or a request for
deletion of one or more existing uses, in accordance with FIFRA section
6(f).
(5) A modification to registration of a currently registered
product that may be accomplished under the notification or non-
notification provisions of Sec. 152.46 and any procedures issued
thereunder. Notwithstanding the preceding sentence, compliance with
this subpart is required if the Administrator has, by written notice
under Sec. 152.46, determined that the modification may
[[Page 68304]]
not be accomplished by notification or non-notification.
(6) Any type of amendment if the Administrator determines, by
written finding, that Agency consideration of data would not be
necessary in order to approve the amendment under FIFRA section
3(c)(5).
(7) Compliance with Agency regulations, adjudicatory hearing
decisions, notices, or other Agency announcements that unless the
registration is amended in the manner the Agency proposes, the
product's registration will be suspended or canceled, or that a hearing
will be held under FIFRA section 6. However, this paragraph does not
apply to amendments designed to avoid cancellation or suspension
threatened under FIFRA section 3(c)(2)(B) or because of failure to
submit data.
4. Section 152.83 is redesignated as Sec. 152.82 and the
introductory text of newly redesignated Sec. 152.82 is revised to read
as follows:
Sec. 152.82 Definitions.
For the purposes of this subpart, the definitions set forth in the
Federal Insecticide, Fungicide, and Rodenticide Act, in Sec. 152.3,
and in this section apply. In addition, the term ``exclusive use
study'' shall have the meaning set forth in Sec. 152.83.
5. Section 152.83 is added, to read as follows:
Sec. 152.83 Definition of exclusive use study.
A study is an exclusive use study if it meets the conditions of
either paragraph (a) or paragraph (b) of this section.
(a) Initial exclusive use period. A study submitted to support the
registration of a product containing a new active ingredient (new
chemical) or new combination of active ingredients (new combination) is
an exclusive use study if all the following conditions are met:
(1) The study pertains to a new active ingredient (new chemical) or
new combination of active ingredients (new combination) first
registered after September 30, 1978.
(2) The study was submitted in support of, or as a condition of
approval of, the application resulting in the first registration of a
product containing such new chemical or new combination, or an
application to amend such registration to add a new use.
(3) Less than 10 years have passed (or up to 13 years, if the
period of exclusive use protection has been extended under FIFRA
section 3(c)(1)(F)(ii)) since the issuance of the registration for
which the data were submitted.
(4) The study was not submitted to satisfy a data requirement
imposed under FIFRA section 3(c)(2)(B).
(b) Exclusive use period for certain minor use data. A study
submitted by an applicant or registrant to support an amendment adding
a new minor use to an existing registration that does not retain any
period of exclusive use under paragraph (b)(1) of this section is an
exclusive study under FIFRA section 3(c)(1)(F)(vi) if all the following
conditions are met:
(1) The study relates solely to a minor use of a pesticide.
(2) The applicant or registrant at the time the new use is
requested has notified the Administrator that any exclusive use
pesticide for the period has expired and that the study is eligible for
exclusive use treatment.
(3) Less than 10 years have passed since the study was submitted to
EPA.
(4) The study was not submitted to satisfy a data requirement
imposed under FIFRA section 3(c)(2)(B).
(5) The minor use supported by the data has not been voluntarily
canceled nor have such data been used to support a non-minor use.
6. Section 152.84 is revised to read as follows:
Sec. 152.84 When materials must be submitted to the Agency.
Information and materials required by this subpart must be
submitted at the time of application, unless the application is
determined not to be subject to the requirements of this subpart.
7. Section 152.86 is amended by revising paragraph (b)(2)(iv) to
read as follows:
Sec. 152.86 The cite-all method.
* * * * *
(b) * * *
(2) * * *
(iv) The applicant's name, address and contact information,
including a telephone number and e-mail address.
8. Section 152.90 is amended by revising the reference in the last
sentence of the introductory text from ``demonstrating'' to
``claiming,'' and by revising paragraphs (a) and (b)(6) to read as
follows:
Sec. 152.90 The selective method.
* * * * *
(a) List of data requirements. (1) Each applicant must submit a
list of the data requirements that would apply to his/her pesticide,
its active ingredients, and its use patterns, if the product were being
proposed for registration under FIFRA section 3(c)(5) for the first
time.
(2) The applicant must list the applicable requirements, as
prescribed by part 158 of this chapter or part 161 of this chapter, as
applicable. All required (R) studies, and any studies that could be
conditionally required (CR) based upon composition, use pattern, or the
results of required studies, are to be listed. The applicant need not
list data requirements pertaining to any ingredient which qualifies for
the formulators' exemption.
(b) * * *
(6) Claim of a data gap. Refer to Sec. 152.96.
9. Section 152.91 is amended by revising paragraphs (a) and (c), to
read as follows:
Sec. 152.91 Waiver of a data requirement.
* * * * *
(a) Request for extension of an existing waiver. An applicant may
claim that a waiver previously granted by the Agency also applies to a
data requirement for his/her product. To document this claim, the
applicant must provide a reference to the Agency record that describes
the previously granted waiver, such as an Agency list of waivers or an
applicable Registration Standard, Reregistration Eligibility Decision
document or Registration Review decision document, and explain why that
waiver should apply to his/her product.
* * * * *
(c) Effect of denial of waiver request. A decision by the Agency to
deny a written request for a new waiver or an extension of an existing
waiver is a final Agency action. Following denial, the applicant must
choose another method of satisfying the data requirement.
10. Section 152.95 is amended by revising the introductory text and
by revising paragraph (b)(2)(v), to read as follows:
Sec. 152.95 Citation of all studies in the Agency's files pertinent
to a specific data requirement.
An applicant normally may demonstrate compliance for a data
requirement by citation of all studies in the Agency's files pertinent
to that data requirement. The applicant who selects this cite-all
option must submit to the Agency:
* * * * *
(b) * * *
(2) * * *
(v) The applicant's name, address and contact information,
including a telephone number and e-mail address.
* * * * *
11. Section 152.96 is revised to read as follows:
[[Page 68305]]
Sec. 152.96 Claim of data gap.
(a) When a data gap may be claimed. Except as provided in paragraph
(b) of this section, an applicant may defer his/her obligation to
satisfy an applicable data requirement until the Agency requires the
data if no other person has previously submitted to the Agency a valid
study that would satisfy the data requirement in question.
(b) When a data gap may not be claimed--(1) Product containing a
new active ingredient. An applicant for registration of a product
containing a new active ingredient may not defer his/her obligation by
claiming a data gap unless he/she can demonstrate to the Agency's
satisfaction that the data requirement was imposed so recently that
insufficient time has elapsed for the study to have been completed and
that, in the public interest, the product should be registered during
the limited period of time required to complete the study. Refer to
FIFRA section 3(c)(7)(C).
(2) Product not containing a new active ingredient. An applicant
for registration of a product under FIFRA section 3(c)(7)(A) or (B) (a
product not containing a new active ingredient) may not defer his/her
obligation by claiming a data gap if the data are:
(i) Data needed to determine whether the product is identical or
substantially similar to another currently registered product or
differs only in ways that would substantially increase the risk of
unreasonable adverse effects on the environment.
(ii) Efficacy data specific to the product, if required to be
submitted to the Agency.
(iii) If a new use is proposed for a product that is identical or
substantially similar to an existing product, data to demonstrate
whether the new use would substantially increase the risk of
unreasonable adverse effects on the environment.
(c) Approval of application with a data gap claim. (1) In
accordance with Sec. 152.115(a), any registration that is approved
based upon a data gap claim shall be conditioned on the submission of
the data no later than the time that the data are required to be
submitted for similar products already registered.
(2) Notwithstanding paragraph (c)(1) of this section, the Agency
will not approve an application if it determines that the data for
which a data gap claim has been made are needed to determine if the
product meets the requirements of FIFRA section 3(c)(5) or 3(c)(7).
12. Section 152.97 is revised to read as follows:
Sec. 152.97 Rights and obligations regarding the Data Submitters
List.
(a) Each original data submitter shall have the right to be
included on the Agency's Data Submitters List.
(b) Each original data submitter who wishes to have his/her name
added to the current Data Submitters List must submit to the Agency the
following information:
(1) Name and current address.
(2) Chemical name, common name (if any) and CAS number (if any) of
the active ingredient(s), with respect to which he/she is an original
data submitter.
(3) For each such active ingredient, the type(s) of study he/she
has previously submitted (identified by reference to data/information
requirements listed in part 158 of this chapter or part 161 of this
chapter as applicable), the date of submission, and the EPA
registration number, file symbol, or other identifying reference for
which it was submitted.
(c) Each applicant not already included on the Data Submitters List
for a particular active ingredient must inform the Agency at the time
of submission of a relevant study whether he/she wishes to be included
on the Data Submitters List for that pesticide.
13. Section 152.99 is amended by removing paragraph (a)(2)(iv),
redesignating paragraphs (a)(2)(v) and (a)(2)(vi) as (a)(2)(iv) and
(a)(2)(v), and revising newly redesignated paragraph (a)(2)(iv) to read
as follows:
Sec. 152.99 Petitions to cancel registration.
* * * * *
(a) * * *
(2) * * *
(iv) The applicant has falsely or improperly claimed that a data
gap existed at the time of his/her application.
[FR Doc. 2010-27906 Filed 11-4-10; 8:45 am]
BILLING CODE 6560-50-P