Document ID: EPA-HQ-OPP-2009-0456-0001
Agency: epa
Document Type: Proposed Rule
Title: Procedures to Ensure Protection of Data Submitters Rights: Pesticides; Satisfaction of Data Requirements
Posted Date: 2010-11-05T04:00Z

[Federal Register Volume 75, Number 214 (Friday, November 5, 2010)]
[Proposed Rules]
[Pages 68297-68305]
From the Federal Register Online via the Government Printing 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: smoot.cameo@epa.gov.

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