Federal Register / Vol. 79, No. 24 / Wednesday, February 5, 2014 / Rules and Regulations 6819 

each point on its outer edge or from its 

construction site, but may not interfere 

with the use of recognized sea lanes 

essential to navigation. This rule is 

categorically excluded from further 

review under paragraph 34(g) of Figure 

2–1 of the Commandant Instruction. An 

environmental analysis checklist 

supporting this determination and a 

Categorical Exclusion Determination are 

available in the docket where indicated 

under ADDRESSES. 

List of Subjects in 33 CFR Part 147 

Continental shelf, Marine safety, 

Navigation (water). 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 147 as follows: 

PART 147—SAFETY ZONES 

■ 1. The authority citation for part 147 

continues to read as follows: 

Authority: 14 U.S.C. 85; 43 U.S.C. 1333; 

Department of Homeland Security Delegation 

No. 0170.1. 

■ 2. Add § 147.849 to read as follows: 

§ 147.849 Safety Zone; Olympus Tension 

Leg Platform. 

(a) Description. The Olympus Tension 

Leg Platform is in the deepwater area of 

the Gulf of Mexico in Mississippi 

Canyon Block 807B. The facility is 

located at 28° 9′35.59′′ N, 89°14′20.86′′ 

W. The area within 500 meters (1640.4 

feet) from each point on the structure’s 

outer edge and the area within 500 

meters (1640.4 feet) of each of the 

supply boat mooring buoys is a safety 

zone. 

(b) Regulation. No vessel may enter or 

remain in this safety zone except the 

following: 

(1) An attending vessel; 

(2) A vessel under 100 feet in length 

overall not engaged in towing; or 

(3) A vessel authorized by the 

Commander, Eighth Coast Guard 

District or a designated representative. 

Dated: January 10, 2014. 

Kevin S. Cook, 

Rear Admiral, U.S. Coast Guard, Commander, 

Eighth Coast Guard District. 

[FR Doc. 2014–02441 Filed 2–4–14; 8:45 am] 

BILLING CODE 9110–04–P 

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. 

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 http://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 http://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 


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6820 Federal Register / Vol. 79, No. 24 / Wednesday, February 5, 2014 / Rules and Regulations 

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 

§ 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 § 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 § 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 § 152.81(b) by 

removing the list of amendments in 

§ 152.81(b)(4) that do not require 

compliance with subpart E and instead 

refer to the notification and nonnotification provisions of § 152.46. 

Through proposed § 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 § 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 nonexhaustive list of such amendments. 

Further, EPA believes the regulation’s 

express exclusion of registration 

amendments subject to the notification 

and non-notification provisions of 

§ 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 http://

www.epa.gov/PR_Notices/pr98-10.pdf. 

PR Notice 98–10 was developed 

pursuant to § 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 caseby-case basis in connection with 

specific amendment requests. EPA is 

finalizing the language in § 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 §§ 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. 


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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 § 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 §§ 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 § 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 


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6822 Federal Register / Vol. 79, No. 24 / Wednesday, February 5, 2014 / Rules and Regulations 

forms and therefore cannot permit 

applicants to submit certifications ‘‘at 

any later time prior to the approval of 

the application,’’ as previously provided 

in § 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 §§ 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 § 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 

§ 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 § 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, § 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 

§ 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 § 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 


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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 § 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 

§ 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 

§ 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 § 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. 


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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 

■ 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. Revise the heading of subpart E to 

read as follows: 

Subpart E—Satisfaction of Data 

Requirements and Protection of Data 

Submitters’ Rights 

■ 3. Revise § 152.81 to read as follows: 

§ 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 §§ 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 § 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 § 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 


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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. 

§ 152.83 [Redesignated as § 152.82] 

■ 4. Redesignate § 152.83 as § 152.82. 

■ 5. Amend newly redesignated 

§ 152.82 by revising the introductory 

text and removing the definition for 

‘‘Exclusive use study’’. 

The amendments read as follows: 

§ 152.82 Definitions. 

For the purposes of this subpart, the 

definitions set forth in the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA), in § 152.3, and in this 

section apply. In addition, the term 

‘‘exclusive use study’’ shall have the 

meaning set forth in § 152.83. 

* * * * * 

■ 6. Add § 152.83 to read as follows: 

§ 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. 

■ 7. Revise § 152.84 to read as follows: 

§ 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. 

■ 8. In § 152.86, revise paragraph 

(b)(2)(iv) to read as follows: 

§ 152.86 The cite-all method. 

* * * * * 

(b) * * * 

(2) * * * 

(iv) The applicant’s name, address, 

and contact information, including 

telephone number and email address. 

* * * * * 

■ 9. In § 152.90, revise the last sentence 

of the introductory text and paragraphs 

(a) and (b)(6) to read as follows: 

§ 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 

§ 152.96. 

■ 10. In § 152.91, revise paragraphs (a) 

and (c) to read as follows: 

§ 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. 

■ 11. In § 152.93, revise paragraph 

(b)(2)(v) to read as follows: 

§ 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. 

* * * * * 

■ 12. In § 152.95, revise the introductory 

text and paragraph (b)(2)(v) to read as 

follows: 

§ 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 


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6826 Federal Register / Vol. 79, No. 24 / Wednesday, February 5, 2014 / Rules and Regulations 

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. 

* * * * * 

■ 13. Revise § 152.96 to read as follows: 

§ 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 

§ 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). 

■ 14. Revise § 152.97 to read as follows: 

§ 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. 

■ 15. In § 152.99: 

■ a. Remove paragraph (a)(2)(iv). 

■ b. Redesignate paragraphs (a)(2)(v) 

and (a)(2)(vi) as paragraphs (a)(2)(iv) 

and (a)(2)(v). 

■ c. Revise newly redesignated 

paragraph (a)(2)(iv) and paragraph 

(b)(2). 

The amendments read as follows: 

§ 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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0668; FRL–9388–7] 

Cyantraniliprole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

cyantraniliprole in or on multiple 

commodities that are identified and 

discussed later in this document. E.I. du 

Pont de Nemours & Company (DuPont) 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

February 5, 2014. Objections and 

requests for hearings must be received 

on or before April 7, 2014, and must be 

filed in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2011–0668, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

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 http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 


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