 




                                                    
                                               
                                               
                                Response to Public Comments
                                   on the Proposed Rule:
                           "Satisfaction of Data Requirements;
                                   Procedures to Ensure
                        Protection of Data Submitters' Rights"

                                       
                                       
                                       
                               December 9, 2013

                                       




						


                               Table of Contents

      I.	Introduction	Page 2

      II.	Commenters	Page 2

III.       Comments and Responses	Page 3
      



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.



      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  




                                       
                                       
                                       
                                       
                                       
                                       
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.

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 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 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 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 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.       
   
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 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 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 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 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 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 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 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 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)
   
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. 
   
   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 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.
   
   
    
