1

Response to Public Comments

on the Proposed Rule:

“Satisfaction of Data Requirements;

Procedures to Ensure

Protection of Data Submitters’ Rights”

December 9, 2013
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Table of Contents

I. Introduction....................................................................................................Page 2

II. Commenters........................................................................................Page 2

III. Comments and Responses .............................................................................Page 3
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I. Introduction

On Friday, November 5, 2010, EPA published in the Federal Register a proposed rule 

(75 FR 68297) to update certain aspects of 40 CFR part 152, subpart E regulations governing 

satisfaction of data requirements and the associated data rights procedures. The regulations were 

promulgated in 1984 and have served satisfactorily since then. EPA has, however, identified the 

need to update the provisions to reflect changes in the statute and related practices over time.

This “Response to Public Comments” document addresses public comments that EPA 

has received on the proposed rule. These comments are available at www.regulations.gov using 

the docket identifier EPA-HQ-OPP-2009-0456. EPA proposed to the revisions to subpart E on 

November 5, 2010, beginning a comment period which was set to end on January 4, 2011. EPA 

extended the comment period, in response to requests from CropLife America, the American 

Chemistry Council Biocides Panel for a 30-day extension, to February 3, 2011 (January 4, 2011) 

(76 FR 302) (FRL-8858-2). This “Response to Public Comments” document provides a 

summary of the comments received during the entire comment period and EPA’s responses to 

those comments. 

II. Commenters

The following two private citizens and eight companies or organizations submitted

comments on the proposed rule:

Commenter # DCN (1) Affiliate

1

EPA-HQ-OPP- 2009-0456-

0006

ExxonMobil Chemical 

Company

2

EPA-HQ-OPP- 2009-0456-

0007

Private Citizen

3

EPA-HQ-OPP- 2009-0456-

0008

Private Citizen

4

EPA-HQ-OPP- 2009-0456-

0009 Monsanto Company

5

EPA-HQ-OPP- 2009-0456-

0010

Carter Ledyard & Milburn 

LLP

6

EPA-HQ-OPP- 2009-0456-

0011 CropLife America

7

EPA-HQ-OPP- 2009-0456-

0012 Bayer CropScience

8

EPA-HQ-OPP- 2009-0456-

0013

Syngenta Crop Protection, 

LLC

9

EPA-HQ-OPP- 2009-0456-

0014

American Chemistry Council: 

Biocides Panel

10 EPA-HQ-OPP- 2009-0456-

0015

Chemical Producers & 

Distributors Association

KEY:

(1) This is the number that is used to identify this comment in the docket at www.regulations.gov and in this document to refer to this 

particular commenter.
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The comments have been grouped into specific topic or subject categories. The section 

of the regulation addressed by the commenters appears after the topic heading. This document is 

organized by topic as follows:

A. Applicability (40 CFR 152.81 and 40 CFR 152.46)

B. Update Definition of Exclusive Use Study (40 CFR 152.83)

C. When Materials Must Be Submitted (40 CFR 152.84)

D. Addition of Electronic Means of Contacting Data Submitters (40 CFR 152.86 and 40 

CFR 152.95)

E. Selective Method (40 CFR 152.90)

F. Data Waivers (40 CFR 152.91)

G. Elimination of Certification and Documentation Procedures for Data Gaps (40 CFR 

152.96)

H. Petitions to cancel registration (40 CFR 152.99)

I. Miscellaneous 
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III. Comments and Responses

A. Applicability of the Procedures to Ensure Data Submitters’ Rights (40 CFR 152.81 and 

40 CFR 152.46)

1. Comment: Commenters EPA–HQ–OPP–2009–0456-0014 and EPA–HQ–OPP–2009–0456-

0011 questioned how data submitters’ rights would be addressed under a Data Call-In (DCI).

Commenter EPA-HQ–OPP–2009–0456-0011 argued that making the procedures established 

in a DCI controlling if the procedures differ from the regulations, as in proposed 40 CFR 

152.81(a)(3), would nullify the protections afforded by the administrative process used to 

develop Subpart E and could result in the establishment of arbitrary procedures.

EPA response: EPA 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 practice 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 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 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 section 3(c)(1)(F) apply with equal force to data submitted under 

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. Comment: Commenter EPA–HQ–OPP–2009–0456-0014 stated that the proposed rule

remains largely related to ‘generic’ data on active ingredients and does not adequately 

address what should be done when applicants cite existing data (or request data waivers) for 

product specific data such as acute toxicity data, even when the formulator’s exemption may

apply for the generic data.

EPA response: EPA does not agree that the proposal is somehow more focused on 

“generic” data rather than “product-specific” data. The data protections provided by FIFRA 

section 3 and the implementing regulations apply with equal force to data on active 

ingredients and data developed to support specific product formulations. EPA did not 

propose any revisions that would modify the regulations in that respect. As the existing

regulations make clear, when an applicant cites previously submitted data to satisfy an 

applicable data requirement – be it a generic data requirement or a product-specific data 

requirement -- the applicant must comply with the part 152, subpart E procedures. EPA

believes no changes are needed to address this matter.
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3. Comment: Commenter EPA–HQ–OPP–2009–0456-0014 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 part 152, subpart E. The commenter questioned 

the intent of the provisions in proposed 40 CFR 152.81(b)(6), which would exclude from the 

scope of part 152 “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).”

EPA response: EPA proposed to revise § 152.81(b) by removing the list of amendments at 

§ 152.81(b)(4) that do not require compliance with subpart E and instead refer to the 

notification and non-notification provisions of § 152.46. Through proposed § 152.81(b)(6), 

however, EPA retained 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 part 152 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 PR Notice 98-10 (available on the internet at 

http://www.epa.gov/PR_Notices/pr98-10.pdf. PR Notice 98-10) which 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 case-by-case basis in connection with specific amendment requests. EPA will 

finalize the language in § 152.81(b) as proposed. 

4. General Comment: Commenter EPA–HQ–OPP–2009–0456-0006 believes the data 

protection regulations should be revised to make clear that studies with an MRID Number 

that are submitted in support of a registration or tolerance application are subject to data 

compensation even when such studies have been submitted or summarized elsewhere as part

of another data submission.

EPA response: EPA did not propose to address in this proposed rule the circumstances under 

which an applicant may cite to summaries or journal articles in lieu of citing to MRIDs, nor
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does EPA believe that there is a need to revise the regulations to address this issue. The 

preamble to the existing regulations promulgated in 1984 already includes an extensive 

discussion regarding the citation of public literature. (49 FR 30896). In that preamble, EPA

acknowledged that FIFRA expressly allows citation to public literature as an alternative to 

citation of previously submitted data. However, the agency made clear that the public 

literature must be, by itself, sufficient to satisfy the Agency data requirement for which it is 

being cited. The preamble explained that was unlikely to be the case in most circumstances 

because, 

EPA’s experience in reviewing both data submitted directly by applicants, 

and journal articles from the public literature, shows that most such articles 

do not contain sufficient information, in themselves, to satisfy a registration 

data requirement. Published research typically describes the test methods 

and presents the results of the research in summary form. Such articles, 

however, rarely offer the detailed information (such as raw data results) 

needed by the Agency to reach sound conclusions about the risks and 

benefits of the pesticide and to judge the validity of the study. This is 

particularly true of long-term studies, where the expense of the research 

would be most likely to cause concern about economic protection. (49 FR 

30896). 

EPA has not departed from this position. Furthermore, EPA does not accept citations to 

summaries of data that have previously been submitted to EPA to support a registration 

or tolerance action in lieu of citing the actual study. Were EPA to allow citation to

summary results of previously submitted data under FIFRA or FFDCA in lieu of citing 

the actual studies being summarized, the data protections provided by FIFRA and the 

FFDCA would largely be eliminated. Such an approach would effectively permit 

follow-on applicants to evade compensation requirements by simply referencing EPA's

own summaries of registrant data or some other publicly accessible summary of the 

study results. EPA does not believe this was the intent of Congress in creating the data 

protection provisions of FIFRA section 3(c)(1)(F). EPA therefore believes it is 

unnecessary to amend the regulations or articulate a new policy on this matter. 

5. Comment: Commenter EPA–HQ–OPP–2009–0456-0009 requests that EPA consider 

expanding § 152.81 to include, “each registrant to whom a product registration has been 

transferred.”

EPA response: This comment goes beyond the scope of EPA’s proposal, as 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. EPA addressed and resolved this issue 

in 1984 when it developed the current data protection procedures. At that time, EPA 

concluded that the data compensation procedures of FIFRA section 3(c)(1)(F) were intended 

to cover only applications for registration submitted under that section. (49 FR 30891). 

Registration transfers are not applications for registration under FIFRA within the meaning 

of section 3(c)(1)(F) (iii), but simply the transfer of ownership of a current registration from 

one person to another without the submission or consideration of a section 3 application for 

registration, including the consideration of data. Thus, EPA concluded in 1984 that these 
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actions were not subject to the data compensation procedures prescribed by FIFRA and EPA 

has not chosen to reopen that determination in developing the 2010 proposal to amend 

subpart E. 

6. Comment: Commenters EPA–HQ–OPP–2009–0456-0012 and EP-HQ–OPP–2009–0456-

0012 asked EPA to clarify that, to the extent that private funds are confirmed by IR-4 as the 

source of support for some of all of the costs of particular studies, the private source is 

entitled to compensation for the portion of the costs it provided.

EPA response: EPA did not propose to make changes to the portion of the regulations

addressing the citation of public literature or government supported data, nor does EPA 

believe that there is a need to revise the regulations to address this issue. EPA has addressed 

the issue of exclusive use protection for data generated by IR-4 in a guidance document,

“Questions and Answers - Exclusive Use Data Protection for Minor Use Registrations,” most 

recently revised in September, 2012, and available on the internet at

http://www.epa.gov/opp00001/minoruse/exclusive-use-questions.pdf. There, EPA explained

that while minor use registrations supported by IR-4 data can be counted towards the number 

of minor uses necessary to extend an existing period of data exclusivity (if they meet certain 

criteria), the data generated by IR-4 do not themselves receive exclusive use protection 

because they have been generated by the government or with government funds and therefore 

are considered to be government-generated data under § 152.94. EPA continues to affirm 

that position. It is important to recognize that exclusive use rights are not segregable -- data 

either are or are not exclusive use data; there can be no “partial” right to exercise exclusive 

use over the citation of data. Therefore, extending exclusive use rights in this instance would 

effectively create a windfall for an original registrant by allowing a limited private 

investment to leverage government funds and resources to effectively exclude competitors 

from relying on IR-4 or other government-generated data. EPA believes it would be 

inconsistent with the purposes of FIFRA to reward exclusive use treatment for data that have 

been generated or funded to some extent by the government since FIFRA allows public 

literature to be cited freely. 

EPA’s position on compensation rights for IR-4 data differs from its position on exclusive 

use rights. Unlike exclusive use rights, private data compensation rights can effectively be 

segregated from the government’s contribution to the development of the data. EPA

therefore believes applicant or registrant-submitted data are entitled to compensation rights 

even when there may have been some measure of government involvement in the generation 

or funding of the data. EPA believes that the data submitter and the follow-on applicant can,

through negotiation (or arbitration, should negotiations fail), determine the portion of a data 

development activity that was supported by private funds and therefore subject to 

compensation. It should be noted, however, that when EPA receives data from IR-4 or other 

government agencies rather than from an applicant or registrant, it presumes these to be 

government-generated data under §152.94 and therefore “public literature” within the 

meaning of FIFRA section 3(c)(1)(F). Thus, if applicants wish to receive compensation for 

data that may have been jointly developed with a government agency, the data must be 

submitted to EPA by the applicant or registrant. 
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7. Comment: Commenter EPA–HQ–OPP–2009–0456-0006 notes that emergency exemptions 

from registration under FIFRA section 18 require the submission of supporting data but are 

not subject to FIFRA’s data compensation regulations, and can be extended indefinitely so 

long as the emergency condition exists. The commenter requests that EPA modify section 40 

CFR 152.81(b)(3) to limit the exemption from EPA’s data compensation scheme to 

emergency approvals with a total duration (either initial or extended by re-certification or 

renewal) of one year or less.

EPA response: As noted in earlier in response to comment A.5, 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. EPA notes, however, that it addressed and resolved this issue in 1984 

when it developed the current subpart E procedures. At that time, EPA concluded that the 

data compensation procedures of FIFRA section 3(c)(1)(F) were intended to cover only 

applications for registration submitted under that section. (49 FR 30884 and 30891). 

Emergency exemptions under section 18 of FIFRA are not applications for registration under 

FIFRA within the meaning of in section 3(c)(1)(F) (iii). To the contrary, they are exemptions 

from the requirements of registration. Thus, EPA concluded in 1984 that these actions were 

not subject to the data compensation procedures prescribed by FIFRA. EPA has not chosen 

to reopen that determination in developing the 2010 proposal to amend subpart E. 

8. Comment: Commenter EPA–HQ–OPP–2009–0456-0013 requests that EPA acknowledge 

that protections of FIFRA sections 3 and 10 extend to all data submitted under the FFDCA in 

support of petitions for tolerances and exemptions from tolerance. Commenters HQ–OPP–

2009–0456-0006, HQ–OPP–2009–0456-0011, and HQ–OPP–2009–0456-0012 requested 

that EPA modify its regulations to make clear that they apply to inert ingredients and data 

submitted to secure either a tolerance or a tolerance exemption for inert ingredients. The 

commenters believe that EPA should explicitly acknowledge that the protections of FIFRA 

section 3 and 10 extend to data submitted under FFDCA in support of tolerance or 

exemptions from tolerance for inert ingredients.

EPA response: EPA did not propose to address protections for data submitted under FFDCA 

in support of tolerance or exemptions of tolerance, including data submitted for inert 

ingredients. This comment, therefore, goes beyond the scope of EPA’s proposal. However, 

EPA notes that it has already made public its position regarding the protections provided for 

data submitted to support tolerance actions for inert ingredients. On April 17, 2003, EPA

announced for comment 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 FFDCA to address exclusive use and compensation 

rights for data submitted to EPA in support of tolerance and tolerance exemption actions (68 

FR 18977).

EPA’s position, as articulated in that white paper, is that FFDCA section 408(i) provides both 

exclusive use and data compensation protections for data that inert ingredient manufacturers 

submit to EPA to establish or maintain tolerances or tolerance exemptions for these

ingredients. Specifically, exclusive use protection applies to data submitted to EPA to 
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establish the first tolerance or tolerance exemption for a chemical and extends for the 10-year 

period following the establishment of that initial tolerance or tolerance exemption. Data 

compensation rights apply to all data submitted to EPA to support or maintain a tolerance or 

tolerance exemption and extend for the 15-year period following submission of the data.

EPA protects these rights by ensuring that pesticide formulators applying for registration or 

amended registration under FIFRA do either of the following: (1) use as a source of an inert

ingredient a supplier that has satisfied applicable data submission obligations for that inert 

ingredient; or (2) submit or cite such data themselves. When previously submitted exclusive 

use data are cited, the citation must be accompanied by the authorization of the original data 

submitter or the person to whom such rights have been transferred. In the case of 

compensable data, the citation must be accompanied by evidence that an offer to pay

compensation has been made.

9. Comment: Commenters HQ–OPP–2009–0456-0006, HQ–OPP–2009–0456-0011, and HQ–

OPP–2009–0456-0012, and HQ–OPP–2009–0456-0013 requested that EPA create a separate 

Inert Ingredients Data Submitters List to facilitate data protection for inert ingredients as 

EPA previously announced it would be.

EPA Response: EPA announced in the Federal Register, in connection with the Endocrine 

Disruptor Screening Program, its intention to establish a Pesticide Inert Ingredients Data 

Submitters & Suppliers List (PIIDSSL) to identify any entity who has submitted 

compensable data on a pesticide inert ingredient in response to a test order issued under 

section 408(p) of the FFDCA (April 15, 2009)(74 FR 17560)(FRL-8399-9). The PIIDSSL

would also indentify submitters of compensable data in support of tolerances or exemptions 

from tolerances for inerts under section 408(i). EPA anticipates that it will release the 

PIIDSSL during 2013. While the PIIDSSL is under development, EPA’s InertFinder, 

available at www.epa.gov/pesticides/inertfinder, list those inert ingredients for which data 

protection rights have been asserted.

10. Comment: Commenter HQ–OPP–2009–0456-0006 argued that determining “substantial 

similarity” for inert ingredients can be more complex than for active ingredients, and hence 

EPA should develop criteria and procedures for making such a determination. In addition, the 

commenter believes that where EPA makes a finding of “substantial similarity,” it should 

notify the original data submitter of this finding and provide an opportunity to comment on 

the finding. Further, to enable meaningful review and comment, EPA should include with the 

notification an explanation of the criteria and the data used to support the finding.

EPA Response: As mentioned in response to comment A.8, EPA did not propose to address 

protections for data submitted for inert ingredients, nor did EPA propose to address how it 

makes “substantial similarity” determinations for either formulated products or inert 

ingredients; hence, this comment goes beyond the scope of EPA’s proposal. The 

determination of whether particular pesticide products or inert ingredients are substantially

similar to one another is a complex EPA scientific judgment EPA makes when comparing the 

properties of products and ingredients. The federal courts have made clear that given the 

level of complexity and judgment involved in this exercise, these determination are 

inherently discretionary and not subject to review by the courts. See Syngenta Crop 
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Protection v. EPA, 439 F.Supp. 2d 458. 462-63 (M.D.N.C. 2006). Once that process 

concludes and EPA determines that a product or an ingredient is substantially similar to an 

existing product, the applicant would have to demonstrate that they had satisfied any data 

compensation obligations with respect to the applicant’s product. 

As mentioned in response to comment A.9, EPA is committed to establishing a Pesticide 

Inert Ingredients Data Submitter’s and Suppliers List. To the extent inert ingredient data 

submitters believes their rights in protected data have been violated, EPA intends that 

petitioners use as a guide the procedures established at §152.99 for protection of FIFRA 

section 3(c)(1)(F) data rights. If EPA determines the need to codify procedures to address 

protections for data submitted for inert ingredients, EPA would take this comment under 

further consideration, and further engage stakeholders.

B. Update Definition of Exclusive Use Study (40 CFR 152.83)

1. Comment: The EPA-HQ-OPP-2009-0546-0011 believes that the terms “pesticide” and 

“period” appear to be transposed in the proposed 40 CFR 152.83(b)(2): “The applicant or 

registrant at the time the new use is requested has notified the Administrator that any 

exclusive use pesticide for the period has expired and that the study is eligible for exclusive 

use treatment.” The commenters believe that the sentence would more clearly read, “... any

exclusive use period for the pesticide has expired...”

EPA response: EPA agrees with the commenter and has made the suggested correction in 

the final rule.

2. General Comment: Commenter EPA–HQ–OPP–2009–0456-0006 suggested 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.

EPA response: EPA 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 that is no need to require submission of the actual documentation to EPA. 

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. As discussed in response to comment A.8, EPA 

has addressed the substance of this comment when it announced its position in the 2003 

white paper regarding the application of the data protections of FFDCA section 408(i). In the 

white paper, EPA made clear that 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 section 3 of FIFRA. It is, however, important to 

understand how and when FFDCA data are protected by EPA. While FFDCA section 408(i) 

bestows protections on data submitted under FFDCA, EPA protects those rights through the 
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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. 

C. When Materials Must Be Submitted (40 CFR 152.84)

1. Comment: Several commenters addressed EPA’s proposal to amend 40 CFR 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,” as the regulations currently

provide. Commenters HQ–OPP–2009–0456-0010 and HQ–OPP–2009–0456-0015 suggested 

that EPA adopt the two-step approach that has evolved. Under such an approach a complete 

application would require proof that a “Notification of Intent to File” was provided to 

relevant data owners prior to filing the application. Once EPA makes the determination that 

the data cited is acceptable and notifies the applicant, the applicant would tender offers to 

pay. 

 EPA Response: 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, Public Law 110-94, commonly

called PRIA II). Because 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 the preamble, 

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 proposed to be eliminated from the regulations.

The commenters not supporting EPA’s proposal argued that, contrary to EPA’s position, 

FIFRA section 33(f)(4) leaves EPA with discretion to determine what constitutes 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 appears 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 
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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 assert 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 40 CFR 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 40 CFR 152.84 in its 

current form. There is no dispute that 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 section 33(f)(4)(B) and that, consistent with the requirements of that section, these forms 

must be submitted at the time of application. 

In any case, with the recent passage of the Pesticide Registration Improvement Act of 2012 

(PRIA 3)(Public Law 112-177, September 28, 2012), Congress has only made it more clear 

that a completed data certification form must be submitted at the time of application. 

Specifically, 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 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 section 

33(f)(4)(B)(ii), EPA is required to reject applications that do not include completed data 

certification forms and therefore cannot permit applicants to submit certifications “at any 

later time prior to the approval of the application,” as currently 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 
14

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 section 3(c)(1)(F) obligations and can serve to encourage early

resolution of data compensation disputes. While EPA understands the reasoning for 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, in 1984, 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 proposed to eliminate that process in the 

2010 proposal, and will finalize new § 152.84, as proposed.

2. Comment: Commenter EPA–HQ–OPP–2009–0456-0009 and EPA–HQ–OPP–2009–0456-

0013 requested that EPA clarify whether EPA intended that the time to commence 

negotiations is any time after the application and offer to commence negotiations have been 

tendered. Commenter EPA-HQ-OPP-2009-0456-0013 noted that applicants often wait until 

just prior to the approval of the registration to enter into negotiation, denying data submitters 

the possibility of submitting a petition to deny an application.

EPA response: The proposed rule did not propose any changes to the required terms of an 

offer to pay and commence negotiations as set forth in §§152.86(b)(2) and 152.93(b)(2), nor 

did the proposal otherwise address when negotiations may begin following issuance of an 

applicant’s offer to pay. However, EPA believes that section 3(c)(1)(F)(iii) of FIFRA makes 

clear that negotiations may commence any time after an offer to pay is made. That provision 

sets forth that if the applicant and the original data submitter cannot reach agreement on the 

amount and terms of compensation, either person may request binding arbitration at the end 

of the 90-day period following delivery of the offer to pay. Plainly, therefore, that section 

contemplates that negotiations can begin upon delivery of the offer to pay. It is important to 

recognize, however, that section 3(c)(1)(F) and EPA’s implementing regulations do not 

impose any specific requirements regarding the extent and nature of these negotiations nor do 

they require that the parties reach agreement. Because section 3(c)(1)(F) provides a right to 

binding arbitration as the mechanism for setting compensation in the absence of an 

agreement, EPA believes that it was not the intent of Congress - nor is it necessary - to 

establish specific obligations with respect to data compensation negotiations.

D. Addition of Electronic Means of Contacting Data Submitters (40 CFR 152.86, 152.93

and 152.95)

1. Comment: Commenters EPA–HQ–OPP–2009–0456-0012, EPA–HQ–OPP–2009–0456-

0013, and EPA–HQ–OPP–2009–0456-0014 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 
15

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.

EPA response: The proposal in §§152.86, and 152.95 to create 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 revisions to the regulatory text 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 section 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 proposal to 

prescribe or limit the means by which an applicant delivers offers to pay to data submitters. 

EPA recognizes the efficiencies afforded by e-mail, and the Agency believes that, given 

advances in technology, it would be inappropriate to preclude e-mail 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.

E. The Selective Method (40 CFR 152.90)

1. Comment: Commenters EPA–HQ–OPP–2009–0456-0006, EPA–HQ–OPP–2009–0456-

0009, EPA–HQ–OPP–2009–0456-0012, EPA–HQ–OPP–2009–0456-0013, and EPA–HQ–

OPP–2009–0456-0014 requested EPA to clarify when Reregistration Eligibility Decision 

documents (REDs) and registration review decision documents can be relied on to determine 

data requirements and what data are compensable.

EPA response: EPA received several comments in response to its proposal 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. (75 FR 68300). The existing regulations further 

indicate that if the Registration Standard does not address all required data or there is no 

Registration Standard, the applicant must refer to the codified data requirements in 40 CFR 

part 158 as the alternate source of its list of data requirements. 

As explained in the proposal, the form of EPA decision documents has evolved since the 

1984 regulations were promulgated. (75 FR 68301). Registration Standards were superseded 

beginning in 1988 by REDs as the Agency implemented the reregistration requirements of 

FIFRA section 4. In turn, REDs are being 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 
16

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 part 158 

will constitute the exclusive list of required data that applicants using 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 parts 158 in 

amended § 152.90(a)(2) incorporate this principle. Accordingly, where EPA has imposed 

additional requirements beyond those listed in the 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 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 (75 FR 68300). 

F. Data Waivers (40 CFR 152.91)

1. General Comment: Commenter HQ–OPP–2009–0456-0014 requested that EPA make a list 

of data waivers granted, if such a list exists, publically available and ensure that it is 

maintained in a current manner with clear reference to the basis and location of any decisions 

granting waivers.

EPA response: EPA did not address in the proposed regulation the process for developing or 

issuing data waivers and so the comment is beyond the scope of the rule. EPA does not 

currently maintain a list of data waivers. Applicants can access information regarding data 

waivers for previously registered or re-registered products in REDs. EPA will also make 

those materials available through the Freedom of Information Act, consistent with EPA’s 

information regulations at 40 CFR part 2. In the final rule, EPA is also removing reference 

in § 152.91 to Registration Standards as a list of waivers. As explained in response to 

comment E.1 above, Registration Standards were superseded beginning in 1988 by REDs.

2. General Comment: Commenter HQ–OPP–2009–0456-0014 requests that the Agency

reconsider the proposed wording in § 152.91 that denial of a waiver decision is a final 

Agency action to provide flexibility for a round of further negotiation, or provide better 
17

explanation as to when a denial is final that still will allow for additional justification and 

support.

EPA response: As explained in the proposed rule, the language in question (that denial of a 

waiver is a final agency action) reflects the Agency’s existing position, as set forth in §§

158.45, that waiver denials are final agency action for purposes of judicial review (75 FR 

68304). It was not intended to address the process for either denying or reconsidering a 

waiver. That process is set forth in §§ 158.45 and is beyond the scope of this rulemaking 

action. In this final rule, EPA is simply reiterating its position, as it proposed, that an 

applicant has the right to seek judicial review once EPA actually denies a waiver request.

G. Elimination of Certification and Documentation Procedures for Data Gaps (40 CFR 

152.96)

1. General Comment: Commenter HQ–OPP–2009–0456-0014 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 40 CFR 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.” (75 FR 68302) The commenter contended that this puts a burden upon data 

submitters to search for Agency actions that may be affected. Further, the commenter was 

unclear as to how the Agency proposes to make such information available and is unclear 

whether the information will be available for all applications for either new or amended 

registrations that rely upon the selective method or only for certain ones.

EPA response: 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. However, 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 (75 FR 68301), with the 

completion of reregistration and the development of REDs for all pesticides listing 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.

H. Petitions to Cancel Registration (40 CFR 152.99)
18

1. General comment: Commenter HQ–OPP–2009–0456-0013 argued that some data citers 

have delayed providing offers to pay data submitters until the eve of registration, allowing 

products produced by the data citers to enter the marketplace before the data submitter had an 

opportunity to review the compensation offer and address deficiencies, as provided by EPA’s 

regulations at 40 CFR 152.99. The commenter further maintained that this effectively 

eliminates the right to petition to deny an application (40 CFR 152.99(a)(2)(vii)), but allows 

the data citer to reap financial rewards which potentially should not have been granted in the 

first place. The commenter requested that EPA commit to considering timely filed petitions 

to deny applications before EPA makes its registration decision.

EPA response: EPA believes the commenters concerns are largely addressed by the PRIA 2 

and subsequent PRIA 3 amendments to FIFRA and the corresponding revisions EPA is 

promulgating in this final rule to § 152.84 regarding the timing for submission of materials 

required by part 152, subpart E. As explained in Unit C (When Materials Must be 

Submitted), as a result of the PRIA amendments, complete applications must be submitted at 

the time of application and may no longer be submitted “at any time prior to EPA’s approval 

of the application,” as currently provided in § 152.84. This change has the effect of 

providing the full measure of the applicable PRIA review period for an original data 

submitter to file a petition to deny. In determining whether to grant an application, EPA will 

consider timely petitions to deny and any applicant response, along with all other relevant 

information, consistent with the mandates of PRIA.

1. General Comment: Commenter HQ–OPP–2009–0456-0014 suggested that the Agency

consider a revision to 40 CFR 152.99(b)(2) requiring the use of certified mail. Instead the 

comment asked that EPA allow the use of any delivery method for a hard copy of a petition 

to cancel that provides proof of receipt. The commenter does not believe that electronic 

transmittal is appropriate but that a physical copy should be delivered to the affected 

registrant.

EPA response: While EPA believes that certified mail remains an appropriate means of 

ensuring delivery of a petition to cancel or deny registration to the affected applicant, given 

advances in communication methods and technologies, EPA agrees that the rule should no

longer be limited to a single method of delivery. In this final rule, therefore, EPA is 

amending the existing language in § 152.99(b)(2) requiring “certified mail”, to instead allow 

the use of any method that provides evidence of delivery. 

J. Miscellaneous

1. Comment: Commenters HQ–OPP–2009–0456-0006, HQ–OPP–2009–0456-0012, and HQ–

OPP–2009–0456-0013 requested that EPA further modify its data compensation regulations 

to require that applicants for follow-on registrations submit evidence with their application 

that they have sent, and that data submitters have in fact received, the necessary offers to 

compensate for citing data. According to the commenters, the phrase “evidence of delivery” 

requires that applicants submit with their application actual evidence that offers to pay have 

been not only sent, but received by data submitters.
19

EPA response: This proposed rule did not address the statutory requirement that each 

applicant for a follow-on registration submit to EPA “evidence of delivery” of an offer to pay

the original data submitter. EPA does not believe that written, actual evidence, for exclusive 

use or otherwise, should routinely be submitted to the Agency, nor does the Agency wish to 

receive such paperwork which would have to be processed and filed in substantial volume. 

The current regulations provide that an applicant must certify to the Agency that they have in 

fact either received the appropriate authorizations for exclusive use studies or made offers to 

compensate for non-exclusive use studies. Only if the registration were subsequently

challenged would the Agency ordinarily expect the applicant to present the written evidence 

to verify compliance with the requirement. 

In the over 29 years since the existing subpart E procedures have been in effect, EPA is 

aware of very few situations where applicants have falsely certified to making required offers 

to pay or receiving permission to cite data from a data submitter. Given that filing false 

reports to EPA is a violation of federal law, and that original data submitters can petition the 

agency to deny or cancel a registration for which required offers to pay or permission have 

not been made or received, EPA believes there is already sufficient incentive for applicants 

to comply with the data protection procedures of FIFRA section 3(c)(1)(F) and 40 CFR 152 

subpart E without the need for submission of the actual offers and letters of permission. 

Therefore, EPA believes it is unnecessary to make revisions to the regulations to address this 

matter.

2. General Comment: Commenters HQ–OPP–2009–0456-0012 and HQ–OPP–2009–0456-

0013 contended that requiring the data citer to provide a copy of the proposed label and data 

matrix to the company whose data it is citing would help eliminate disputes regarding which 

data has to be cited. The commenters believe that a confidentiality agreement between the 

citer and the data owner could alleviate citers’ concerns about confidential information.

EPA response: EPA did not propose changes to the required elements of the offer to pay as 

set forth in §§ 152.86, 152.93 and 152.95 and does not believe a change is necessary. EPA 

acknowledges that disputes regarding which data has to be cited can and do occur and that it 

is generally beneficial for both the applicant and the original data submitter to share as much 

information as possible to ensure a prompt and fair resolutions of data compensation 

disputes. EPA does not, however, see a need to impose additional regulatory requirements 

with respect to the offer to pay to ensure proper resolution of data compensation disputes. 

Because the statute gives either party the right to seek binding arbitration within 90 days after 

an offer to pay is made, EPA believes there is already a strong incentive for parties to share 

information necessary to negotiate data compensation agreements without resorting to the 

uncertainties and costs of the arbitration process. EPA understands that the overwhelming 

majority of data compensation disputes are resolved through negotiation, which suggests to 

EPA that the existing regulatory procedures have proven sufficient for allowing the parties to 

reach data compensation agreements without additional regulatory requirements and without 

resort to binding arbitration. In addition, after a registration has been granted the materials 

submitted in accordance with subpart E, including the applicant's list of data requirements, 

the method used by the applicant to demonstrate compliance for each data requirement, and 

the applicant’s citation of specific studies in the Agency’s possession, are available to any 
20

person under Freedom of Information procedures. This policy is clearly stated in § 152.119. 

Thus, even if the applicant does not agree to share its label or data matrix in advance of 

registration, these materials certainly become publicly available after registration and the 

original data submitter can therefore access these materials at that point.

3. General Comment: Commenters HQ–OPP–2009–0456-0011, HQ–OPP–2009–0456-0012, 

and HQ–OPP–2009–0456-0013 pointed out that EPA should update the references from 

FIFRA section 3(c)(1)(D) to section 3(c)(1)(F).

EPA response: On December 12, 2008, EPA published in a final rule (73 FR 75592) a 

technical amendment updating the references from FIFRA section 3(c)(1)(D) to section 

3(c)(1)(F).

4. General Comment: Commenters HQ–OPP–2009–0456-0006 proposed that EPA use 

gender neutral terms instead of gender specific pronouns, changing “his” to “his/her” 

throughout subpart E.

EPA response: EPA appreciates the commenter’s proposal to use the gender neutral term 

“his/her” uniformly in subpart E. After further consideration, however, the Agency believes 

that use of “his” will better maintain consistency with the regulatory text throughout the 

existing regulations in part 152. The Agency will consider the best way to incorporate gender 

neutral terms in future rulemakings.

5. General Comment: Commenter HQ–OPP–2009–0456-0007 stated a belief that there are no 

protections for the rights of citizens to be safe from toxic chemical pollutants, and requested 

the agency extend the comment period for a full year. 

EPA Response: The agency recognizes that some individuals believe that pesticides should 

be banned completely. The commenter has not provided the agency with specific information 

regarding the lack of protections from pesticides. In the absence of additional information, 

the Agency cannot effectively respond to the comment. In response to comments, EPA 

granted a 30-day extension of the comment period from January 4, 2011, to February 3, 

2011.

6. General Comment: Commenter HQ–OPP–2009–0456-0008 provided comments regarding 

the use of the pesticide triclosan in consumer products.

EPA Response: EPA notes that this action concerns data compensation provisions and was 

not related to the use of triclosan.