Pesticides; Satisfaction of Data Requirements; Procedures To Ensure Protection of Data Submitters' Rights, 6819-6826 [2014-02294]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 79, Number 24 (Wednesday, February 5, 2014)]
[Rules and Regulations]
[Pages 6819-6826]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02294]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 152

[EPA-HQ-OPP-2009-0456; FRL-9904-32]
RIN 2070-AJ58


Pesticides; Satisfaction of Data Requirements; Procedures To 
Ensure Protection of Data Submitters' Rights

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is revising and updating its regulations governing the 
procedures for the satisfaction of data requirements under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA). Specifically, this 
regulation addresses procedures for the protection of exclusive use and 
data compensation rights of data submitters, which have not been 
revised since issuance in 1984. These revisions are now needed to 
accommodate statutory changes and related changes in practice that have 
occurred since that time and to make minor changes to clarify the 
regulations.

DATES: This final rule is effective April 7, 2014.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2009-0456, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave., NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Scott Drewes, Field and External 
Affairs Division (7506P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 347-0107; email address: 
drewes.scott@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. What action is the agency taking?

    EPA is revising and updating its regulations governing the 
procedures for the satisfaction of data requirements under FIFRA. 
Specifically, these provisions include procedures for the protection of 
exclusive use and data compensation rights of data submitters. These 
revisions also provide greater clarity when data compensation 
procedures do and do not apply, and update the regulations to be 
consistent with statutory changes and related changes in practice since 
the regulations were first promulgated in 1984.

B. What is the agency's authority for taking this action?

    This action is issued under the authority of FIFRA sections 3 and 
25, 7 U.S.C. 136 et seq.

C. Does this action apply to me?

    You may be potentially affected by this action if you produce 
pesticide products that require registration with EPA. The following 
list of North American Industrial Classification System (NAICS) codes 
is not intended to be exhaustive, but rather provides a guide to help 
readers determine whether this document applies to them. Potentially 
affected entities may include, but are not limited to: Pesticide and 
other agricultural chemical manufacturing (NAICS code 325320), e.g., 
pesticides manufacturing, insecticides manufacturing, herbicides 
manufacturing, fungicides manufacturing, etc.

D. What are the incremental costs and benefits of this action?

    EPA did not quantify the potential costs or benefits from these 
revisions, which are qualitatively discussed in Unit V. EPA has 
determined that there are minimal incremental costs for industry to 
comply with the requirement that applicants submit data compensation 
materials at the time of application for registration. As such, EPA has 
concluded that the per firm and industry level impact of the rule is 
not significant. Benefits are derived from the efficiencies in the 
registration process gained by the timely submission of data 
compensation materials to EPA, as well as the early resolution of data 
compensation disputes that may arise. EPA also believes benefits accrue 
to applicants through the additional clarity regarding when data 
compensation procedures do not apply.

II. Background

A. Summary of the Proposed Rule

    In the Federal Register of November 5, 2010 (75 FR 68297) (FRL-
8424-8), EPA proposed to revise the regulations governing procedures 
for the satisfaction of data requirements under

[[Page 6820]]

FIFRA. EPA proposed to do the following:
     Replace the limited listing of actions to which subpart E 
does not apply with a single reference to actions that may be 
accomplished by notification or non-notification under Sec.  152.46;
     Update and restructure the existing definition of 
exclusive use period to incorporate the additional exclusive use 
criteria added by the Food Quality Protection Act (FQPA) of 1996;
     Revise Sec.  152.84 to conform to the requirements of 
FIFRA section (33)(f), which now requires data compensation materials 
to be submitted at the time of application; and
     Update the regulations to be consistent with programmatic 
developments since the regulations were first promulgated in 1984, 
including eliminating the data gap procedures, removing the reference 
to Registration Standards, and adding email as a means of contacting 
data submitters.

B. Public Comments and EPA Responses

    EPA has considered the comments received on the proposed rule, and 
provided responses in a Response to Comments document, which is 
available in the docket for this rulemaking. Many commenters requested 
the Agency to make additional revisions that were outside the scope of 
the proposed rule. Only the key comments within the scope of the 
proposed rule and the Agency's responses are discussed in this 
document.
    1. Data submitters rights under a Data Call-In (DCI). Two 
commenters questioned how data submitters' rights would be addressed 
under a DCI. EPA proposed to specify in the applicability section of 
the regulation at 40 CFR 152.81(a)(3) that when a DCI itself 
establishes procedures for the protection of data rights, recipients of 
the DCI must follow the procedures established in the DCI rather than 
the procedures set forth in subpart E. The commenters argued that the 
proposed revisions would nullify the protections afforded by the 
administrative process used to develop subpart E and could result in 
the establishment of arbitrary procedures.
    In response, EPA notes that the Agency did not intend to suggest 
that the data protections of FIFRA section 3(c)(1)(F) do not apply to 
data submitted in response to a DCI. The purpose of the proposed 
amendment to Sec.  152.81(a)(3) was to clarify and codify the Agency's 
existing practices for ensuring protection of data rights in connection 
with the issuance of DCIs. EPA's intent in adding the reference to 
FIFRA section 3(c)(2)(B) was simply to make clear that DCIs are actions 
subject to the data compensation provisions of FIFRA and to acknowledge 
that EPA, pursuant to its authority under FIFRA section 3(c)(2)(B), 
generally establishes compliance procedures in the DCIs it issues. EPA 
believes it is generally simpler and more efficient to include 
provisions for the protection of data in the DCIs themselves in order 
to provide recipients with a single set of instructions for satisfying 
the terms of a DCI. Further, because the process and timing for 
complying with DCIs under FIFRA section 3(c)(2)(B) differs from the 
process for obtaining a new registration, EPA believes it generally 
makes sense to tailor the instructions for addressing the data 
protection requirements of FIFRA to fit the structure of the DCI 
compliance process. As a practical matter, the procedures EPA 
establishes for the protection of data rights in DCIs track those in 
subpart E because, as the commenter points out, the protections of 
FIFRA section 3(c)(1)(F) apply with equal force to data submitted under 
FIFRA section 3(c)(2)(B). Thus, this provision does not have any 
substantive impact on the protection EPA extends to data submitted to 
the Agency under FIFRA.
    2. List of amendments excluded from the scope of subpart E. A 
commenter asked the Agency to provide a single source of current, 
appropriately updated and readily available guidance that specifies 
actions that do not require compliance with subpart E.
    In response, EPA notes that it proposed to revise Sec.  152.81(b) 
by removing the list of amendments in Sec.  152.81(b)(4) that do not 
require compliance with subpart E and instead refer to the notification 
and non-notification provisions of Sec.  152.46. Through proposed Sec.  
152.81(b)(6), however, EPA retains its ability to exclude from the 
provisions of subpart E ``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).''
    The proposed revisions to Sec.  152.81(b) would not change the 
scope of subpart E. As EPA explained in the preamble to the proposed 
amendments, data submission obligations--and therefore compliance with 
the data protection procedures of the subpart E regulations--only apply 
where review of an application requires EPA consideration of scientific 
data in order to make a FIFRA regulatory determination. Because it 
would be difficult to create an exhaustive list of possible 
registration amendment actions that do not require review of data, EPA 
believes it is simpler and less confusing to make that principle clear 
in the regulations without also including what, in the existing 
regulations, was a non-exhaustive list of such amendments. Further, EPA 
believes the regulation's express exclusion of registration amendments 
subject to the notification and non-notification provisions of Sec.  
152.46 from these data protection procedures effectively addresses the 
majority of amendment actions not requiring consideration of scientific 
data. A list of those actions can be found in Pesticide Registration 
(PR) Notice 98-10, available on the Internet at https://www.epa.gov/PR_Notices/pr98-10.pdf. PR Notice 98-10 was developed pursuant to Sec.  
152.46 specifically to identify minor registration amendments that may 
be made by notification or non-notification without the need for Agency 
review of scientific data and are, therefore, not subject to the 
subpart E data protection procedures. EPA believes it is appropriate to 
address other circumstances where scientific review of data is not 
required on a case-by-case basis in connection with specific amendment 
requests. EPA is finalizing the language in Sec.  152.81(b) as 
proposed.
    3. Authorization for use of exclusive use studies for tolerances or 
tolerance exemptions. A commenter proposed that EPA require applicants 
to submit authorizations for use of exclusive use studies to the Agency 
prior to registration or the Agency's granting of a tolerance or 
tolerance exemption if the Agency identifies any exclusive use data 
submitted on the Data Submitter's List.
    In response, EPA notes that the regulations at Sec. Sec.  152.86(a) 
and 152.93(b) already require applicants for FIFRA registration to 
certify prior to registration that they have obtained permission for 
the citation of any exclusive use studies. EPA believes that the 
certification process under those provisions has been effective in 
ensuring that necessary authorizations have been obtained and there is 
no need to require submission of the actual documentation to EPA.
    EPA notes that the commenter's request to extend the proposal to 
apply to the issuance of tolerances and tolerance exemptions goes 
beyond the scope of EPA's proposal. EPA did not propose to make changes 
to the portion of the regulations addressing the types of regulatory 
approvals that are subject to the subpart E procedures. This comment 
therefore goes beyond the scope of EPA's proposal.

[[Page 6821]]

    In 2003, EPA addressed the substance of this comment when it 
announced in the Federal Register of April 17, 2003 (68 FR 18977) (FRL-
7279-9) the availability of a white paper, ``Proposal for Implementing 
Data Compensation Rights for Data Submitted in Support of Tolerance or 
Tolerance Exemption Actions,'' discussing a program to enable the 
Agency to appropriately implement the new provisions contained in 
section 408(i) of the Federal Food, Drug, and Cosmetic Act (FFDCA) to 
address exclusive use and compensation rights for data submitted to EPA 
in support of tolerance and tolerance exemption actions. In that white 
paper, EPA made clear that FFDCA section 408(i) extends exclusive use 
and data compensation rights to data submitted to support or maintain 
tolerances and tolerance exemptions to the same extent provided by 
FIFRA section 3. It is, however, important to understand how and when 
FFDCA data are protected by EPA. While FFDCA section 408(i) bestows 
protections to data submitted under FFDCA, EPA protects those rights 
through the FIFRA registration process when an application for a 
pesticide registration is submitted, not when a tolerance or tolerance 
exemption is sought. Tolerances and tolerance exemptions are rulemaking 
actions, not licenses issued to individuals that sell or distribute 
pesticides or pesticide ingredients. Unlike FIFRA, the FFDCA rulemaking 
process does not, therefore, provide EPA with a means of ensuring 
compliance with exclusive use and compensation requirements by all 
persons who may sell or distribute a product that is covered by a 
tolerance or tolerance exemption. For this reason, EPA ensures 
compliance with exclusive use and data compensation obligations in 
connection with the submission of an application for registration or 
amended registration under FIFRA and not in connection with the 
issuance of a FFDCA tolerance or tolerance exemption.
    4. When materials must be submitted. Several commenters addressed 
EPA's proposal to amend Sec.  152.84 to require submission of all data 
compensation compliance information and materials, including evidence 
of any necessary offers to pay compensation, at the time of application 
rather than ``at any later time prior to EPA's approval of the 
application.''
    In response, EPA notes that the commenters were split regarding 
EPA's proposal to require submission of all data compliance information 
and materials at the time of application. As EPA explained in the 
preamble to the proposed rule, the Agency proposed this change to 
conform the implementing regulations with the requirements of FIFRA 
section 33(f)(4) (as amended by the Pesticide Registration Improvement 
Renewal Act (PRIA II), Pub. L. 110-94, commonly called PRIA II). 
Because FIFRA section 33(f)(4)(B) directs EPA to determine during the 
initial screen (within 21 days after receiving the required 
registration service fee) that ``the application contains all the 
necessary forms, data, and draft labeling,'' EPA believes that 
completed data citation forms must be submitted at the time of 
application. In addition, EPA also cited a policy rationale in support 
of this proposed amendment, noting that the Agency's primary rationale 
for previously allowing data compensation materials to be submitted 
after submission of the application--the time-consuming data gap 
certification process--was being eliminated from the regulations.
    The commenters objecting to EPA's proposal argued that, contrary to 
EPA's position, FIFRA section 33(f)(4) leaves EPA with discretion to 
determine what contents of the application constitute a ``complete 
application.'' They also argued that the Agency's ability to conduct 
reviews of applications would not be limited in any way by allowing 
applicants to submit offers to pay throughout the application review 
process. This group of commenters' primary concern with the proposed 
change appeared to be that it may provide a greater opportunity for 
data submitters to seek compensation and file data compensation 
petitions before uncertainties involving EPA's ``substantial 
similarity'' determinations and related data issues have been resolved. 
To that end, these commenters asked that EPA maintain the current 
language, or that EPA consider an alternative to the proposed amendment 
whereby applicants would be required to provide notice to data 
submitters of their intent to file applications for registration, but 
would not be compelled to tender any associated offers to pay 
compensation unless and until EPA reviewed and accepted the applicant's 
citations to data. They argued that this alternative would not delay 
EPA's review, since review of the offer to pay certification is merely 
an ``administrative function'' and they asserted that this alternative 
could minimize unnecessary and premature data compensation disputes.
    The commenters supporting EPA's proposed amendment agreed with 
EPA's interpretation of PRIA II that completed data compensation 
materials must be submitted as part of the initial application. They 
also argued that allowing applicants to delay submitting required 
offers ``until the eve of registration'' effectively reads the right to 
petition to deny an application out of EPA's regulations and deprives 
EPA of the assistance of the original data submitter in meeting EPA's 
obligation to determine that the applicant has submitted or cited all 
necessary data, consistent with the requirements of FIFRA section 
3(c)(1)(F) and Sec. Sec.  152.80 through 152.99.
    EPA continues to believe that Congress clearly addressed this issue 
with the passage of PRIA II and must therefore reject those comments 
seeking that EPA maintain Sec.  152.84 in its current form. There is no 
dispute that FIFRA section 3(c)(1)(F) requires applicants for 
registration or amended registration to offer to pay compensation to 
original data submitters when the application seeks to rely on 
previously submitted data that are subject to FIFRA compensation 
requirements. EPA requires applicants to submit a data certification 
form to demonstrate that any required offer to pay compensation has 
been made. There can be little question, therefore, that the data 
certification form is a ``necessary form'' within the meaning of FIFRA 
section 33(f)(4)(B) and that, consistent with the requirements of that 
section, these forms must be submitted at the time of application.
    With the recent passage of the Pesticide Registration Improvement 
Act of 2012 (Pub. L. 112-177), Congress has only made it more clear 
that a completed data certification form must be submitted at the time 
of application. Specifically, FIFRA section 33(f)(4)(B)(iv)(II) now 
expressly provides that an application is only considered complete for 
purposes of the preliminary technical screening required by FIFRA 
section 33 if the Administrator determines that ``the application, 
data, or information are consistent with the proposed labeling and any 
proposal for a tolerance or exemption from the requirement of a 
tolerance . . . and are such that, subject to full review under the 
standards of this Act, could result in the granting of the 
application.'' (emphasis added). Since EPA cannot lawfully grant an 
application in the absence of ensuring that an applicant has made all 
necessary offers to pay or received any required letters of 
authorization to cite data, it is clear that EPA cannot consider as 
complete applications that do not include a completed data 
certification form. Consistent with the requirements of FIFRA section 
33(f)(4)(B)(ii), EPA is required to reject applications that do not 
include completed data certification

[[Page 6822]]

forms and therefore cannot permit applicants to submit certifications 
``at any later time prior to the approval of the application,'' as 
previously provided in Sec.  152.84.
    Further, even if EPA had discretion to consider the alternative 
approach offered by the commenters, EPA does not believe that approach 
promotes the efficient and effective review of applications. The notion 
that certain portions of applications should continue to come in 
piecemeal to EPA is not consistent with the prompt and efficient FIFRA 
application process envisioned by PRIA. In addition, ensuring that all 
necessary offers to pay are made is not simply an ``administrative 
function,'' but an obligation that lies at the core of EPA's duty to 
ensure compliance with the data protection provisions of FIFRA section 
3(c)(1)(F). EPA believes that providing data submitters with the 
required offers to pay at the beginning of the application process 
rather than at the end of that process can serve to assist EPA in 
ensuring that the Agency meets its FIFRA section 3(c)(1)(F) obligations 
and can serve to encourage early resolution of data compensation 
disputes. While EPA understands the reasoning why some commenters would 
prefer to engage in those disputes after an application has been 
granted rather than before, EPA does not believe this is a policy 
objective reflected in FIFRA, nor was it EPA's objective when it 
promulgated the original regulation that allowed data compensation 
materials to be submitted after the initial application. The basis for 
that provision was largely to avoid the delay applicants could 
encounter as a result of the data gap certification process. And, as 
noted, EPA has eliminated the data gap process with these amendments.
    5. Electronic means of contacting data submitters. Two commenters 
sought clarification as to whether the proposal to require offers to 
pay to include the applicant's email address applied to data 
submitters, as the title of this section in the preamble to the 
proposed rule might have suggested, or whether it was meant to apply 
only to applicants that are submitting offers to pay compensation. The 
commenters further asserted that they believe that it would not be 
appropriate or sufficient to allow electronic notification as the sole 
method of delivering offers to pay data submitters.
    In response, EPA notes that the provision proposed in Sec. Sec.  
152.86 and 152.95 that creates a requirement to include an email 
address as an additional point of contact is part of the ``offer to 
pay'' requirement that is applicable to applicants, not to data 
submitters. EPA agrees that the title of this section in the preamble 
of the proposed rule may have created some confusion, but EPA believes 
the proposed provisions of the rule are clear that the obligation to 
provide an email address is part of the offer to pay requirement. EPA 
also notes that it inadvertently omitted this language from the offer 
to pay provision in proposed Sec.  152.93(b)(2)(v) and has included it 
in the final rule.
    In response to the commenters' final point, it was not EPA's intent 
in the proposed rule to prescribe or limit the means by which an 
applicant delivers offers to pay to data submitters and the regulations 
in subpart E have not limited the forms of delivery that may be used. 
EPA recognizes the efficiencies afforded by email, and the Agency 
believes that, given advances in technology, it would be inappropriate 
to preclude email as a means of communication between applicants and 
data submitters, including submission of offers. Provided the applicant 
can produce evidence of delivery of the offer to the original data 
submitter, EPA does not believe FIFRA prescribes a precise method of 
delivery.
    Consistent with this view, in this final rule EPA is amending the 
language in Sec.  152.99(b)(2) requiring that data compensation 
petitions be sent by certified mail, to allow the use of any method 
that provides evidence of delivery.
    6. Source of list of data requirements. Several commenters 
requested EPA to clarify when Reregistration Eligibility Decision 
documents (REDs) and registration review decision documents can be 
relied on to determine registration data requirements and to determine 
what data are compensable.
    In response, EPA notes that the Agency proposed in the November 5, 
2010 Federal Register document to eliminate from Sec.  152.90(a) the 
requirement that an applicant use an issued Registration Standard, the 
EPA reregistration decision documents issued prior to 1988, as the 
source of its list of data requirements for the selective method. 
Further, Sec.  152.90(a) indicated that if the Registration Standard 
does not address all required data or there is no Registration 
Standard, the applicant must refer to the data requirements in 40 CFR 
part 158 as the alternate source of its list of data requirements.
    As explained in the preamble to the proposed rule, the form of EPA 
decision documents has evolved since the 1984 regulations were 
promulgated. Registration Standards were superseded beginning in 1988 
by 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 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 
explained that it no longer intends to 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. 
Accordingly, the Agency concluded that Sec.  152.90(a)(2) should be 
revised to require applicants to list the applicable EPA data 
requirements at 40 CFR part 158.
    The commenters expressed concern that this amendment could be 
interpreted to allow selective citations to exclude data requirements 
that are not explicitly included in EPA's codified data requirements 
but that may have otherwise been required in connection with 
registration, reregistration, or registration review actions and 
reflected in Agency decision documents such as REDs. The commenters, 
therefore, asked EPA to reinforce that its data regulations are 
flexible and that the Agency can and often does impose additional 
requirements beyond those found explicitly in the data tables. EPA 
agrees with these comments, but does not believe there is any need to 
alter the language of the amendment as proposed. It was not EPA's 
intention to suggest that in all cases the data tables in 40 CFR part 
158 will constitute the exclusive list of required data that applicants 
utilizing the selective method of citation must satisfy. In fact, EPA's 
data regulations make it explicitly clear that the regulations are 
intended to be flexible and that EPA reserves the right to require 
additional data, or, in some instances, to waive studies that EPA 
concludes are not relevant to its registration decision under FIFRA. It 
is EPA's intention that the reference to 40 CFR part 158 in amended 
Sec.  152.90(a)(2) incorporate this principle. Accordingly, where EPA 
has imposed additional requirements beyond those listed in the 40 CFR 
part 158 data tables, applicants will be required to satisfy those 
requirements, consistent with the requirements of subpart E. 
Conversely, where EPA determines that a requirement can be waived or 
that

[[Page 6823]]

alternative information to that listed in the data tables can serve to 
satisfy the data requirement, applicants will not be required to 
satisfy the requirements as set forth in the data tables. As noted in 
the preamble, given the flexibility of the data regulations, 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.
    7. Elimination of certification and documentation procedures for 
data gaps. One commenter noted that, in the preamble to the proposed 
rule, the Agency states that a data submitter would no longer routinely 
receive requests from applicants to confirm a data gap, but that, under 
Sec.  152.119 the Agency ``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.'' The commenter contended that this puts 
a burden upon data submitters to search for Agency actions that may be 
affected. Further, the commenter questioned how the Agency proposes to 
make such information available and whether the information will be 
available for all applications for new or amended registrations that 
rely upon the selective method or only for certain ones.
    In response, EPA notes that while it is true that in the absence of 
receiving a data gap letter, the data submitter will not necessarily 
know at the time of application whether the applicant is claiming that 
a data gap exists, EPA believes there are numerous means to ensure 
protection of a data submitter's interest in compensable data should an 
applicant incorrectly assert that a data gap exists. First, as noted in 
the preamble to the proposed rule, with the completion of 
reregistration and the development of REDs for all pesticides that list 
by guideline the data received and reviewed by EPA, the Agency is now 
in a far better position to evaluate the legitimacy of data gap claims 
than it was when it issued the existing data compensation regulations 
in 1984. Second, data submitters will often have prior notice that an 
applicant is seeking registration when they receive offers to pay 
compensation for any data for which a data gap is not claimed. If they 
believe the offer to pay they receive should also extend to previously 
submitted studies not included in the offer, the data submitter can 
file a petition to deny the application under Sec.  152.99. Finally, 
once a registration is issued, the data submitter may obtain a copy of 
any applicant's data compliance materials through the Freedom of 
Information Act, as provided in Sec.  152.119 and consistent with EPA's 
information regulations at 40 CFR part 2. With that information, the 
data submitter can then file a petition to cancel under Sec.  152.99 if 
the data submitter believes the Agency improperly accepted the 
applicant's data gap claim in lieu of citing data belonging to the data 
submitter.

III. The Final Rule

    With the exception of the modifications discussed in the Unit 
II.B., EPA is finalizing the rule in essentially the same form as the 
proposed rule. The final rule does the following:
     Provides greater clarity when data compensation 
requirements do not apply by highlighting actions that do not require a 
scientific review of data and thus do not require satisfaction of data 
requirements;
     Updates the definition of an ``exclusive use study'' to 
incorporate the additional exclusive use criteria added by the FQPA;
     Conforms to the requirements of FIFRA section 33(f)(4), as 
most recently amended by PRIA II, by requiring applicants to submit 
data compensation materials at the time of application;
     Removes the outdated requirement that applicants use a 
Registration Standard for determining which data requirements need to 
be satisfied for a particular pesticide; instead, applicants will 
simply be directed to the data requirement listings in 40 CFR part 158; 
and
     Updates the regulations to be consistent with Agency 
practices since the regulations were first promulgated in 1984.

IV. FIFRA Review Requirements

    In accordance with FIFRA sections 25(a) and (d), the Agency 
submitted a draft of this final rule to the appropriate Congressional 
Committees, the Secretary of Agriculture, and the FIFRA Scientific 
Advisory Panel (SAP). The SAP and the Secretary of Agriculture waived 
review of this rule.

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    On May 5, 2011, the Office of Management and Budget (OMB) 
determined that this action is not a ``significant regulatory action'' 
under the terms of Executive Order 12866 (58 FR 51735, October 4, 
1993), and is therefore not subject to review by OMB under Executive 
Orders 12866 and 13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burdens 
that require additional review or approval by OMB under PRA, 44 U.S.C. 
3501 et seq. Burden is defined at 5 CFR 1320.3(b). An agency may not 
conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a currently valid OMB 
control number. The OMB control numbers for EPA's regulations in 40 CFR 
are displayed in the Federal Register and are listed in 40 CFR part 9.
    The information collection requirements contained in this rule are 
already approved by OMB under OMB control numbers 2070-0060 (EPA ICR 
No. 0277) and 2070-0174 (EPA ICR No. 2288.01). Since there is no new 
burden, it was not necessary to amend the Information Collection 
Requests (ICRs).

C. Regulatory Flexibility Act (RFA)

    Pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), after 
considering the potential economic impacts of this 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. For purposes of assessing the impacts of this 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.
    3. A small organization that is any not-for-profit enterprise which 
is independently owned and operated and is not dominant in its field.
    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 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.

[[Page 6824]]

    EPA believes that the final rule would not have any adverse impacts 
on affected small entities, because the revisions are of minimal impact 
and do not increase activities or related burden. The revisions change 
the timing, but do not alter the substance of the existing pesticide 
data submission or citation obligations. The revisions are expected to 
simplify the procedures for the satisfaction of data requirements. 
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. EPA has therefore concluded that the final rule will not 
have any adverse impacts on affected small entities.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of UMRA (2 U.S.C. 1531-
1538). Therefore, this action is not subject to the requirements of 
UMRA.

E. Executive Order 13132: Federalism

    This action does not have a 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 Executive Order 13132 (64 
FR 43255, August 10, 1999). Since States or local governments are 
rarely pesticide applicants or registrants, this final rule may seldom 
affect a State or local government. Thus, Executive Order 13132 does 
not apply to this rule.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have tribal implications because it does not 
have any effect on tribal governments, on the relationship between the 
Federal Government and Indian tribes, or on the distribution of power 
and responsibilities between the Federal Government and Indian tribes. 
Accordingly, the requirements of Executive Order 13175 (65 FR 67249, 
November 9, 2000) do not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 (62 FR 19885, 
April 23, 1997) because it is not an economically significant 
regulatory action as defined by Executive Order 12866, nor does it 
establish an environmental standard that is intended to mitigate health 
or safety risks, nor would it otherwise have a disproportionate effect 
on children.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This final rule is not subject to Executive Order 13211 (66 FR 
28355, May 22, 2001) because it is not likely to have any adverse 
effect on the energy supply, distribution, or use of energy.

I. National Technology Transfer and Advancement Act (NTTAA)

    This final rule does not impose any technical standards that would 
require Agency consideration of voluntary consensus standards provided 
in section 12(d) of the NTTAA, 15 U.S.C. 272 note.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    EPA has determined that this final rule will not have 
disproportionately high and adverse human health or environmental 
effects on minority or low-income populations. This rule only impacts 
entities that intend to register or currently hold registrations for 
pesticides. It does not involve special consideration of any 
environmental justice related issues as delineated by Executive Order 
12898 (59 FR 7629, February 16, 1994).

VI. Congressional Review Act (CRA)

    Pursuant to the CRA, 5 U.S.C. 801 et seq., EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of the rule in the Federal Register. 
This action is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 152

    Environmental protection, Administrative practice and procedure, 
Pesticides and pests, Reporting and recordkeeping requirements.

    Dated: January 27, 2014.
James Jones,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.

    Therefore, 40 CFR part 152, subpart E is amended as follows:

PART 152--PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES

0
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.


0
2. Revise the heading of subpart E to read as follows:

Subpart E--Satisfaction of Data Requirements and Protection of Data 
Submitters' Rights

0
3. Revise Sec.  152.81 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 the Federal 
Insecticide, Fungicide, and Rodenticide Act (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 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 (EUP) 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, under 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 not be 
accomplished by notification or non-notification.
    (6) Any type of amendment if the Administrator determines, by 
written

[[Page 6825]]

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.


Sec.  152.83  [Redesignated as Sec.  152.82]

0
4. Redesignate Sec.  152.83 as Sec.  152.82.
0
5. Amend newly redesignated Sec.  152.82 by revising the introductory 
text and removing the definition for ``Exclusive use study''.
    The amendments 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 (FIFRA), 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.
* * * * *

0
6. Add Sec.  152.83 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 a 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 the Federal 
Insecticide, Fungicide, and Rodenticide Act (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 period 
for the pesticide 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.

0
7. Revise Sec.  152.84 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.

0
8. In Sec.  152.86, revise 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 telephone number and email address.
* * * * *

0
9. In Sec.  152.90, revise the last sentence of the introductory text 
and paragraphs (a) and (b)(6) to read as follows:


Sec.  152.90  The selective method.

    * * * Sections 152.91 through 152.96 contain specific procedures 
for citing or submitting a study or claiming a data gap.
    (a) List of data requirements. (1) Each applicant must submit a 
list of the data requirements that would apply to his pesticide, its 
active ingredients, and its use patterns, if the product were being 
proposed for registration under the Federal Insecticide, Fungicide, and 
Rodenticide Act (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, 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 data gap. Refer to Sec.  152.96.

0
10. In Sec.  152.91, revise paragraphs (a) and (c) to read as follows:


Sec.  152.91  Waiver of a data requirement.

* * * * *
    (a) Request for an extension of an existing waiver. An applicant 
may claim that a waiver previously granted by the Agency also applies 
to a data requirement for the 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 Reregistration Eligibility Decision (RED) document or 
registration review decision document, and explain why that waiver 
should apply to the 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.

0
11. In Sec.  152.93, revise paragraph (b)(2)(v) to read as follows:


Sec.  152.93  Citation of a previously submitted valid study.

* * * * *
    (b) * * *
    (2) * * *
    (v) The applicant's name, address, and contact information, 
including a telephone number and email address.
* * * * *

0
12. In Sec.  152.95, revise the introductory text and 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

[[Page 6826]]

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 email address.
* * * * *

0
13. Revise Sec.  152.96 to read as follows:


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 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 obligation by 
claiming a data gap unless he 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 the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 
3(c)(7)(C).
    (2) Product not containing a new active ingredient. An applicant 
for registration of a product under FIFRA sections 3(c)(7)(A) or (B) (a 
product not containing a new active ingredient) may not defer his 
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 sections 3(c)(5) or (7).

0
14. Revise Sec.  152.97 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 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 Chemical Abstracts 
Service (CAS) number (if any) of the active ingredients(s), with 
respect to which he is an original data submitter.
    (3) For each such active ingredient, the type(s) of study he has 
previously submitted (identified by reference to data/information 
requirements listed in part 158 of this chapter), 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 the submission of a relevant study whether he wishes to be included 
on the Data Submitters List for that pesticide.

0
15. In Sec.  152.99:
0
a. Remove paragraph (a)(2)(iv).
0
b. Redesignate paragraphs (a)(2)(v) and (a)(2)(vi) as paragraphs 
(a)(2)(iv) and (a)(2)(v).
0
c. Revise newly redesignated paragraph (a)(2)(iv) and paragraph (b)(2).
    The amendments 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 application.
    (b) * * *
    (2) Notice to affected registrant. At the same time that the 
petitioner files his petition with the Agency, the petitioner shall 
send a copy to the affected applicant or registrant by certified mail 
or by any other method that provides evidence of delivery. The affected 
applicant or registrant shall have 60 days from the date of receipt of 
the petition to submit written comments to the Agency.
* * * * *
[FR Doc. 2014-02294 Filed 2-4-14; 8:45 am]
BILLING CODE 6560-50-P