1 **Response to Public Comments**  **on the**  **Proposed Rule: “Satisfaction of Data Requirements;**  **Procedures to Ensure Protection of Data Submitters’ Rights”** 

December 9 , 20132 **Table of**  **Contents** I. Introduc tio n ................................ ................................ ................................ .... Page 2 II. Commenter s ................................ ................................ ........................ Page 2 III. Comments and Re sponse s ................................ ................................ ............. Page 33

**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 prov isions 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 request s from CropL ife 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 # DC**  **N (**  **1 )**  **Affiliate** 1 EPA - HQ - OPP - 2009 - 0456 -

0006 ExxonMobil Chemical Com pany 2 EPA - HQ - OPP - 2009 - 0456 -

000 7 Private Citizen 3 EPA - HQ - OPP - 2009 - 0456 -

000 8 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) Th is is the number that is us e d to identi f y th i s comment in the doc k e t at w ww . r e gu lat i on s .gov and in this do cum ent to refer to this parti cu lar c o mmenter.4

The comments have been grouped into specific topic or subject categories. The section of the regulation addressed by the comme nters 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 Docume ntation Procedures for Data Gaps (40 CFR 152.96) H. Petitions to cancel registration (40 CFR 152.99) I. Miscellaneous5

**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

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– 0456 - 0011 questioned how data submitters’ rights would be addressed under a Data Call - In (DCI). Commenter EPA - HQ

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– 0456 - 0011 argued that making the procedures esta blished in a DCIcontrolling 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 appl y t o 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 m ake clear that DCI s are actions subject to the data compensatio n provisions of FIFRA , and to acknowledge that EPA, pursuant to its authority

under section 3(c)(2)(B), generall y establishes compliance procedures in the DCIs it issues . EPA believes it is generall y simpler and more efficient to include provisions for the protection of data in the DCI s 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 proces s 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 DCIcompliance process. As a practical matter, the procedures EPA est ablishes for the protection of data rights in DCI s track those in subpart E because, as the commenter points out, the protections of section 3(c)(1)(F) appl y with equal force to data submitted under section 3(c)(2)(B). Thus, this provision does not have a ny substantive impact on the protection EPA extends to data submitted to the Agency under FIFRA. **2. Comment:**  Commenter EPA

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– 0456 - 0014 stated that the propos ed rule remains largel y related to ‘generic’ data on active ingredients and does not adequatel y address what should be don e 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 dat a. **EPA response** : EPA does not agree that the propos al is somehow more focused on “generic” data rather than “product - specific” data. The data protections provided by FIFRA section 3 and the implementing regulations appl y with equal force to data on active ingredients and data develope d to support specific product formulations . EPA did not propose an y revisions that would modify the regulations in that respect. As the existing regulations make clear, when an applicant cite s 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 p art 152 , s ubpart E procedures. EPA believes no changes are needed to addr ess this matter.6

**3. Comment:**  Commenter EPA

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– 0456 - 0014 asked the Agency to provide a single source of current, appropriatel y updated and readil y available guidance that specifies actions that do not require compliance with part 152 , s ubpart E. T he co mmenter questioned the intent of the provisions in proposed 40 CFR 152.81(b)(6), which would exclude from the scope of p art 152 “an y t ype 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 noti fication 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 “an y t ype of amendment if the Administrator determines, b y written finding, that Agency c onsideration of data would not be necessary in order to approve the amendm ent under FIFRA section 3(c)(5). ” The proposed revisions to § 152.81(b) would not change the scope of subpart E. A s EPA explained in the preamble to the propos ed amendments, data submission obligations

– and therefore compliance with the data protection procedures of the p art 152 s ubpart E regulations

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apply where review of an applicati on 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 regulati ons without also including what, in the existing regulations, was a non exhaustive list of such amendments. Further, EPA believes the regulation’s express exclusion of registration amendments subject to the notification and non - notification provisions of § 152.46 from these data protection procedures effectivel y address es 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 spec ificall y to identify minor registration amendments that may be made b y notification or no n - notification without the need for Agency review of scientific data , and are , therefore, not subject to the s ubpart E data protection procedures. EPA believes it is appropriate to address other circumstances where scientific review of data is not require d 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

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– 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 wh en such studies have been submitted or summarized elsewhere as part of another data submission. **EPA response** : EPA did not propose to address in th is proposed rule the circumstances under which an applicant may

cite to summaries or journal articles in lieu of citing to MRIDs , nor7

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, suff

icient 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 b y 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 res earch in summary form. Such articles, however, rarely

offer the detailed information (such as raw data results) needed b y the Agency to reach sound conclusions about the risks and benefits of the pesticide and to judge the validity of the study . This is particularl y 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 previousl y 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 b y FI FRA and the FFDCA would largel y be eliminated . Su ch an approach would effectivel y permit follow - on applicants to evade compensation requirements by simply referencing EPA's own summaries of regi strant data or some other publicly a ccessible 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

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– 0456 - 0009 requests that EPA consider expanding § 152.81 to include, “each registrant to whom a product re gistration has been transferred.” **EPA response:** This comment go es beyond the scope of EPA’s proposal, as EPA did not propose to make changes to the portion of the r egulations addressing the ty pes 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 onl y 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 o f 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 these8

actions were not subject to the data compensation procedures prescribed b y FIFRA and EPA has not chosen to reopen that determination in developing the 2010 proposal to amend subpart E. **6. Comment:**  Commenters EPA

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– 0456 - 0012 and EP - HQ

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– 0456 - 0012 asked EPA to clari fy that, to the extent that private funds are confirmed by I R - 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 r egulations 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 I R - 4 in a guidance document , “ Questions and Answers - Exclusive Use Data Protection for Minor Use Registrations , ” most recentl y 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 support ed by IR - 4 data can be count ed towards the number of minor uses necessary

to extend an existing period of data exclusivity **(** if they meet certain criteria), th e 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. Itis important to recognize th at 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 . Theref ore, e xtending exclusive use rights in th is instance would effectivel y create a windfall for an original registrant by allowing a limited private investment to leverage government funds and resources to effectively exclude competitors from rel yi ng 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 effectivel y 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 b y private funds and therefore subject to compens ation. 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 th e meaning of FIFRA section 3(c)(1)(F). Thus, if applicant s wish to receive compensation for data th at may

have been jointly developed with a government agency , the data must be submitted to EPA by the applicant or registrant.9

**7. Comment:**  Commenter EPA

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– 0456 - 0006 notes that emergency exemptions from registration under FIFRA s ection 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. T he 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 r enewal) of one ye ar 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 r egulations addressing the ty pes 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 onl y applications for registration submitted under that section. ( 49 FR 30884 and 30891). Emergency

exemptions un der section 18 of FIFRA are not applications for registration under FIFRA within the meaning of in section 3(c)(1)(F) (iii) . T o the contrary , they are exemptions from the requirements of registration. Thus, EPA concluded in 1984 that these actions were no t subject to the data compensation procedures prescribed b y FIFRA . EPA has not chosen to reopen that determination in developing the 2010 proposal to amend subpart E. **8. Comment:**  C ommenter EPA

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– 0456 - 0013 requests that EPA acknowledge that p rotections 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

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– 0456 - 0006, HQ

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– 0456 - 0012 requested that EPA m odify

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 F IFRA 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 FFD C A 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 protecti ons 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 Toleran ce 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 th at white paper, is that FFDCA section 408(i) provide s 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 the se ingredients. Specificall y, exclusive use protection applies to data submitted to EPA to10

establish the first tolerance or tolerance exemption for a chemical and extends for the 10 - ye ar peri od 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 appl yi ng for registration or amended registration under FIFRA do either of the following: (1) u se as a source of an inert ingredient a supplier that has satisfied applicable data submission obligations for th at inert ingredient ; or (2) submit or cit e 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 who m 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

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– 0456 - 0006, HQ

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– 0456 - 0013 requested that EPA create a separate In ert Ingredients Data Submitters L ist 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 PI IDSSL 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

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– 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 i nclude 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 p ropose 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 in gredients 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 thi s exercise, these determination are inherently

discretionary

and not subject to review by the courts. See S yn genta Crop11

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 In ert In gredients 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 establ ished at §152.99 for protection of FIFRA sec tion 3(c)(1)(F) data rights. If EPA determines the need to codify procedures to address protections for data submitted for inert ingredients, EPA w ould take th is 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 h as made the suggested correction in the final rule. **2. General Comment:**  Commenter EPA

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– 0456 - 0006 suggested that EPA require applicants to submit authorization s 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

exclus ive 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 an y e xclusive 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 r egulations addressing the ty pes 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 th is comment when it announced its position in the 2003 white paper regarding the applic ation of the data protections of FFDCA section 408(i ). In th e 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 the12

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 individual s 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 b y 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 connec tion with the issuance of a FFDCA tolerance or tolerance exemption. **C. When Materials Must Be Submitted (40 CFR 152.84) 1.**  **Comment:** Several comment er s addressed EPA’s proposal to amend 40 CFR 152.84 to require submission of all data compensation compliance information and materials, including evidence of an y necessary offers to pay compensation, at the time of application rather than “at an y later time prior to EPA’s approval of the application,” as the r egulations currently provide. Commenters HQ

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– 0456 - 0015 suggest ed 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 submissio n 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) (a s amended by the Pesticide Registration Improvement Renewal Act, Public Law 110 - 94, commonly called PRIA II). Because sec t i o n 33(f)(4)(B) directs EPA to determine during the initial screen (within 21 day s after receiving the required registration service fee) that “the application contains all the necessary forms, data, and draft labeling,” EPA believes that completed data c itation forms must be submitted at the time of application. In the preamble , EPA also cited a policy

rationale in support of this pro posed 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 argue d that, contrary to EPA’s position, FIFRA section 33(f)(4) leaves EPA with discretion to determine what constitute s a “complete application.” They

also argue d that the A gency ’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. To13

that end, these commenters aske d that EPA maintain the current language, or that EPA consider an alternative to the proposed amendment whereb y applicants would be required to provide notice to data submitters of their intent to file applications for registration, but would not be compel led to tender an y associated offers to pay compensation unless and until EPA reviewed and accepted the applicant’s citations to data. They argue d 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 compe nsation materials must be submitted as part of the initial application. They

also argue d that allowing applicants to delay submitting required offers “until the eve of registration” effectivel y 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 1 52.8 0 through 152 .99. EPA continues to believe that Congress clearl y 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 rel y on previously submitted data that are subject to FIFRA compensation requirements. EPA requir es applicants to submit a data certification form to demonstrate that an y 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 an y case, with the recent passage of the Pesticide Registration Improvement Act of 2012 (PRIA 3) (Public Law 112 - 177, September 28, 2012), Congress has onl y made it more clear that a completed data certification form must be submitted at the time of application. Specificall y, 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 th e Administrator determines that “the application, data, or information are consistent with the proposed labeling and an y 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 h as 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 s ection 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 currentl y provided in § 152.84. Further, even if EPA had discretion to consider the alternative approach offered b y the commenters , EPA does not believe that approach promotes the efficient and effective review14

of applications. The notion that certain portions o f applications should continue to come in piecemeal to EPA is not consistent with the prompt and efficient FIFRA application process envision ed by

PRIA. In addition , ensuring that all necessary offers to pay

are made is not simply an “administrative funct ion,” 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 re asoning 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 largel y 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 f inaliz e new § 152.84, as proposed . **2. Comment:**  Commenter EPA

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– 0456 - 0013 requested that EPA clarify whether EPA intended that the t ime to commence negotiations is an y 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 ne gotiation, den yi ng 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 aft er 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 follo wing 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 impos e 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 abs ence 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

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– 0456 - 0012, EPA

–HQ

– OPP

–2009

– 0456 - 0013, and EPA

–HQ

– OPP

–2009

– 0456 - 0014 sought clarification as to whether th e 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 whether15

it was meant to apply only to applicants that are submitting offers to pay compensation. The commenters further a sserted that they believe that it would not be appropriate or sufficient to allow electronic noti fication as the sole method of delivering offers to pay data submitters. **EPA response :**  T he propos al in §§ 152.86 , and 152.95 t o 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 co nfusion, 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 m eans by which an applicant delivers offers to pay to data submitters . EPA recognizes the efficiencies afforded b y 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 Selec tive Method (40 CFR 152.90)**  **1. Comment:**  Commenters EPA

–HQ

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– 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 ( RED s) and r egistration r eview d ecision 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 elimin ate 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 existin g regulations further indicate that i f 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 d ata 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 b y REDs as the Agency implemented the reregistration requirements of FIFRA sec tion 4. In turn, REDs are being superseded or updated b y determinations made under the r egistration r eview program required b y FIFRA sec tion 3(g) and 40 CFR part 155. Given the growth and evolution of the program’s sy stematic review of existing pesticides, EPA explained that it no longer intends to identify by regulation a specific ty

pe of decision document as the source of data requirement listings. These docum ents are a snapshot of the data requirements at a particular review period, and are likel y to become outdated over time as EPA’s risk assessments evolve and new ty pes of data are needed. Accordingl y, the16

Agency concluded that § 152.90 (a) ( 2 ) should be revi sed to require applicants to list the applicable EPA data requirements at 40 CFR p art 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 rei nforce 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 langua ge of the amendment as proposed. It was not EPA’s intention to suggest that in all cases the data tables in p art 158 will constitute the exclusive list of required data that applicants u s ing the selective method of citation must satisfy . In fact, EPA’s d ata 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 p arts 158 in amended § 15 2 .90 (a) (2) incorporate this principle. Accordingl y, where EPA has imposed additional requirements beyond those listed in the p art 158 data tables, applicants will be require d to satisfy

those requirements , consistent with the requirements of subpart E . Conversel y, 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

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– 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 granti ng 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 currentl y maintain a list of data waivers . Applicants can access in formation regarding data waivers for previousl y 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 better17

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 §§ 158.4 5 , 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 ru lemaking action. In this final rule, EPA is simply reiterat ing 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

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– 0456 - 0014 noted that, i n 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 day s after registration the means by which an applicant satisfied the data requirements, including whether, under the selective method, the applicant claimed a d ata gap.” (75 FR 68302 ) The c ommenter contend ed that this puts a burden upon data submitters to search for Agency actions that may

be affected. Further, the commenter wa s unclear as to how the Agency proposes to make such information available and is unclear whether the information wi ll be available for all applications for either new or amended registrations that rel y 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 necessaril y 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 protecti on 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 propos ed rule (75 FR 68301) , with the completion of reregistration and the development of REDs for all pesticides list ing by guideline the data received and reviewed b y 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 an y data for which a data gap is not claimed. If they believe the offer to pay

they receive should also extend to previousl y 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 an y 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 Ag ency improperl y accepted the applicant’s data gap claim in lieu of citing data belonging to the data submitter. **H . Petitions to**  **C ancel**  **R egistration (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 b y 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 effectivel y eliminates the right to petition to deny an application (40 CFR 152.99(a)(2)(vii) ) , but allows the data citer to reap financ ial rewards which potentially should not have been granted in the first place. The commenter request ed 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 largel y 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 b y part 152, s ubp art 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 currentl y 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 suggest ed that the Agency consider a revision to 40 CFR 152.99(b)(2) requiring the use of certified mail. Instead the comment a sked that EPA allow the use of an y 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 phy sical copy should be delivered to the affecte d registrant. **EPA response:** While EPA believes that certified mail remains an appropriate means of ensuring delivery

of a petition to cancel or den y 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 amend ing the existing language in § 152.99(b)(2) requiring “certified mail”, to instead allow the use of an y method that provides evide nce 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 commenter s , the phrase “evidence of delivery” requires that appli cants 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 follo w - on registration s ubmit to EPA “evidence of delivery” of an o ffer to pay the original data su

bmitter. EPA does not believe that written , actual evidence, for exclusive use or otherwise, should routinely be submitted to the Agency , nor does the A gency wish to receive such paperwork which would have to be processed and filed in substantial volume. The current regulations provid e that an applicant must certify to the Agency

that they have in fact either received the appropriate authorizations for exclusi ve 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 2 9 ye ars since the existing subpart E procedures have been in effect, EPA is aware of very

few situations where applicants have falsel y certified to making required offers to pay or receiving permission to cite data from a data submitter. Give n that filing false reports to EPA is a violation of federal law, and that original data submitters can petition the agency to den y or cancel a registration for which required offers to pay or permission have not been made or received, EPA believes there i s 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 cop y 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 commenter s believe that a confidentiality agreeme nt 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 beli eve a change is necessary . EPA acknowledges that disputes regarding which data has to be cited can and do occur and that it is generall y 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 giv es either party the right to seek binding arbitration within 90 day s 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, inclu ding 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 an y20

person under Freedom of In formation procedures. This policy is clearl y 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 certainl y become publicly available after registration and the ori ginal data submitter can therefore access these materials at that point . **3. General Comment:**  Commenters HQ

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– 0456 - 0011, HQ

– OPP

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– 0456 - 0012, and HQ

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–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 updat ing the references from FIFRA section 3(c)(1)(D) to section 3(c)(1)(F). **4. General Comment:**  Commenters HQ

– OPP

–2 009

– 0456 - 0006 proposed that EPA use gender neutral terms inst ead 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” uniforml y 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 15 2 . The Agency will consider the best way to incorp orate gender neutral terms in future rulemakings. **5. General Comment:**  Commenter HQ

– OPP

–2009

– 0456 - 000 7 stated a belief that there are no protections for the rights of citizens to be safe from toxic chemic al 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 completel y. The commenter has not provided the agency with specific info rmation regarding the lack of protections from pesticides. In the absence of additional information, the Agency

cannot effectively

respond to the comment. Inresponse 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.