June 17, 2011 Attachment 1 Summary of Key I ssues of Concern Identified in The Biocides Panel’s Comments to EPA

- HQ

- OPP

- 2008

- 0110 The Biocides Panel (The Panel) submitted comments on the Proposed Rule for Data Requirements for Antimicrobial Pesticides on April 6, 2009 (the Proposal)

. 1 Throughout its comments, the Panel offers suggestions for improvement or for alternative approaches where appropriate. The Panel made a significant effort to offer constructive approaches to address the issues it identified with the Proposal, including specific alternative approaches to, for example, toxicology

data requirement tables. The following is a very brief and general summary of the Panel’s areas of concern with the Proposed Rule, with reference to the locations in the Panel’s comments where those topics are addressed in greater detail

. The Lack of Information on How EPA Will Conduct Risk Assessments Is a Critical Shortcoming in Assessing the Need to Fulfill Data Requirements This and all other EPA data requirement regulations are designed to provide EPA with the information it requires to evaluate applications for new products and new uses and to reevaluate registered antimicrobial pesticides. EPA has provided extensive documentation on the manner in which it eva luates conventional pesticides . This is based on scientific principles and extensive external collaboration with independent experts, including the FIFIRA Scien tific Advisory Panel. The Panel is aware of no written policies or guidance documents for cond ucting risk assessments for antimicrobial pesticides. Instead, decisions on necessary data, risk assessments to be performed and regulatory decisions all appear to be developed on a case

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- case basis. This results in significant variation in the manner in which compounds with similar uses are evaluated. Additionall y, there is no explanation as to how any particular study will be used in evaluating risks from a compound in a particular use. As a result, there is a lack of clarit y as to what data require ments are relevant. This was discussed in the Panel Comments at pages 12

- 16 , as well as throughout Appendices C

- I.
It is not difficult to illustrate the practical difficulties caused b y the lack of toxicological or environmental risk assessment guidanc e. For example, there is no EPA

- accepted methodology for estimating dietary

exposures from various antimicrobial uses. The Panel has developed and provided to EPA a model for estimating exposures from residential uses, but it has not been

1 Since that t ime, the Panel has met with EPA several times to present sel ected aspects of those comments :

 October 1, 2009: D iscussion paper s on six high priority issues were sent to Ms. Joan Harrigan

- Farrelly, along with suggestions as to how those issues might be addressed.
 December 9, 2009: Presentation to EPA/AD on priority issues and concerns, with supporting documents briefly and generally outlining all areas where the Panel had concerns.
 June 1 0, 2010: Presentation to EPA/OPP on priority concerns, along with an issues briefing paper

.  February 7, 2011: Letter to EPA/OPP outlining the Panel’s areas of concern.
 May 17, 2011: Meeting with EPA/OPP on selected areas of concern.Steven Bradbury , Ph.D. and Joan Harrigan

- Farrelly

Attachment 1 June 17, 2011 Page 2 of 8

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- adopted b y EPA at this time. Therefore, there is no way for an antimicrobial registrant or applicant to know the exposure value that will be applied in risk assessment. This is a critical absence. These approaches should be issued before the Agency imp lements data re quirements, so registrants and EPA staff can understand how the risk assessment process will function. Similarly , there is absolutely no public information about how EPA will perform environmental risk assessments for antimicrobials. The Agency is assert ing that essentially all indoor uses of antimicrobials will result in environmental exposures as a result of “down the drain ” uses. For many antimicrobial uses there is simply no support for this assertion. For example, material preservatives are incorpo rated into treated materials’ matrices (exempt treated articles) to protect the material for extended periods of time. They are not designed to disperse from the material. Nonetheless, EPA at least on one occasion has assumed that 100 percent of the annu al production volume of a material preservative would be discharged down the drain , which is not even justified as a screening level anal ys is. EPA should make a priorit y of developing substantiated environmental risk assessment approaches that can be pres umptively applied to all products in a particular use pattern. Such guidance will allow the regulated community , the public and EPA staff to understand how particular data should be used. This is particularl y important as EPA begins to perform Endangere d Species Act assessments on pesticides. See Panel Comme nts, Appendices G, H and M

. The Proposal Does Not Provide Adequate Guidance to the Regulated Community One consequence of the uncerta int y about risk assessment approaches for antimicrobial use scen arios is that the Proposal leaves too many decisions to a case

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- case determination by EPA, instead of providing scientifically based criteria for determining data requirements. This effectivel y compromises the ability of registrants to anticipate requir ements for registration and also leads to inconsistent regulation. There are strong policy and practical reasons for revising the Proposal to eliminate the many situations calling for individual consultations. The regulated community , in essence, has no way to determine a path to obtain a registration from the regulations. While it is important to maintain flexibility , and therefore include an option for consultation , consultation should not be the primary basis of determining the appli cabilit y of data r equirements. See P anel General Comments, pages 8

- 12 and Appendix K. Final Testing Guidelines Are Not Available for Many Data Requirements
In man y places, EPA’s Proposal on Subpart 158W refers to guidance documents that are either not available or are outdated. Moreover, many of the testing guidelines are not relevant to antimicrobial use patterns. Registrants therefore do not have the necessary guidance for evaluating whether a particular data requirement is applicable or, if so, how best to address it

. It is vitally important that the Agency provide current, consistent, and reliable guidance and standards associated with each data requirement. EPA has established a transparent public process, including scientific review, for issuing these guidelines which, if followed, will accomplish this purpose. S ee Panel General Comments, pages 16

- 20, as well as specific comments made throughout Appendices C

- I

.Steven Bradbury , Ph.D. and Joan Harrigan

- Farrelly

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- The Proposal Does Not Include Meaningful Tiering of Data Requirements The Proposal for antimicrobial data requirements would virtually eliminate tiered data requirements. In both the proposed and final rules for conventional chemical pesticides, the Agency identified the importance of tiering data requirements based upon both exposure and hazard conside rations. This is a basic tenet of the risk assessment process. In the Proposal, the Agency claims that it proposes to “tier” the data requirements by assigning certain categories of antimicrobial products to “high” or “low” exposure categories but provid es no substantiation for the assignment of these categorie s, some of which the Panel cannot understand. Exposure levels cannot simply

be assumed based on product t ype s. Data requirements must be tied to a clear need in the risk assessment process and sho uld be tiered to identify what is needed under specific circumstances. S ee Panel General Comments, pages 25

- 30 , as well as specific comments made throughout Appendices C

- I. The Proposal Does Not Reflect Accurately the Statutory Division of Authority betw een FI FRA and FFDCA EPA’s long

- standing position on the scope of FIFRA section 2(bb) is that the provision “does not apply to a registration decision when a tolerance is not required because use of the pesticide does not result in residues in or on the fo od.” In the preamble to the conventional pesticide proposal, EPA appropriatel y limits its discussion of the coordination of FIFRA 2(bb) to registration actions where a tolerance or exemption is required. However, the preamble to the antimicrobial data re quirement Proposal eliminated an y reference to the requirement for a tolerance or exemption or indeed an y reference to food or feed uses and in fact, states that “It is the applicant’s obligation under FIFRA to demonstrate that an individual product meets the standard under FIFRA and that of FFDCA.” This effectively extends FIFRA 2(bb) to all antimicrobial pesticides. The Panel believes that is not supp orted by law or sound policy

. Panel General Comments, pages 33

- 39. The Proposal Does Not Recognize the Division of Jurisdiction between EPA and FDA
T he Proposal does not clearl y articulate the manner in which antimicrobial food uses would be regulated. The Proposal does not acknowledge that some antimicrobial uses are subject to regulation by

FDA as food additives pursuant to FFDCA section 409, while others are regulated as pesticide chemicals b y EPA pursuant to FFDCA section 408. Instead, it appears to assert EPA’s jurisdiction over antimicrobial food uses where the statutory scheme provides jurisdictio n for such uses to FDA. This is a very serious overstatement of EPA’s authority . As the Proposal recognizes, it will result in dual jurisdiction over antimicrobial products, with two agencies conducting anal ys es. In addition, the lack of an y effort to c oordinate with FDA to develop a coordinated approach to regulation in this area likely will give rise to serious implementation issues. S ee Panel General Comments, pages 31

- 33Steven Bradbury , Ph.D. and Joan Harrigan

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- The Pro posal Does Not Provide Clear Delineation of Food Uses of Antimicrobia l Pesticides Associated with the above issues, the Proposal is unclear as to what constitutes a “food use” subject to regulation under FFDCA 408, as well as what data requirements are relevant for the appropriate risk assessments. In addition, the Propos al attempts to create two separate categories

-- direct and indirect food uses, without explanation, basis in statute, or any basis for distinguishing applicable data requirements. This creates the potential for almost all antimicrobials to be considered as possible leaving residues on food. The way EPA interprets its jurisdiction; this means that this enlarged universe of antimicrobials will be subject to review under the standards of FFDCA 408. This could result in huge additional data requirements. Y et the economic impact is not considered an yw here in the Proposal or supporting documentation. Se e Panel General Comments, pages 37

- 39 and in Appendi ces A and I. Potential Exposures to Antimicrobials Differ from Other Pesticides and Require Different App roaches FIFRA § 3(h), requires EPA to regulate antimicrobial pesticides after considering the degree of risk pose d by

various antimicrobial uses. However, the Proposal’s data requirements fail to take account of the extent to which antimicrobials differ from other pesticides. B oth human and environmental exposures to antimicrobial uses are regulated under other environmental, and health and safet y statutes . The Proposal does not consider these other regulatory programs and whether additional regulation under FIFRA is necessary or appropriate. Further, there are enormous data resources available that can be used as the first tier in an y appropriatel y structured data requirement proposal for exposures of all ty pes. EPA should review and anal yz e these dat a and only then make decisions as to how much additional data and/or mitigation may be necessary and appropriate under FIFRA. See Panel General Comments, pages 39

- 45 and 25

- 30, as well as comments throughout Appendices B

- I. The Panel full y supports the g eneration of applicator exposure monitoring data, particularly the data development program of the Antimicrobial Exposure Assessment Task Force II (AEATF II) . The data from AEATF II will provide scientifically sound estimates of exposures that are essenti al to refine and improve the qualit y of antimicrobial risk assessments. See Panel General Comments, pages 44

- 45 and Appendix G. Reliance upon Alternate Approaches Should Be Built into a Revised Proposal The Panel strongly

recommends that the Agency take this opportunity

to articulate opportunities for new scientific and regulatory approaches in meeting the data requirements for antimicrobial pesticides, such as structure activit y relationship analyses, in vitro approaches, or computational toxicology . T he regulations should explicitly allow the use of these and other new methods and approaches. In addition, guidance providing specific direction on the use of alternative techniques should be developed. The Panel recommends that 40 CFR § 158.70 be amende d to include a paragraph (e) that explicitly permits the use of alternative approaches to addressing data requirements. The Panel further recommends that the Agency expand its efforts to developSteven Bradbury , Ph.D. and Joan Harrigan

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- appropriate guidance for the use of alternative approaches t o addressing data requirements through the involvement of all stakeholders in a public and transparent process and to provide the necessary

education and training of both the stakeholder community and OPP staff. S ee Panel General Comments, pages 45

- 50.
Em erging Pathogen Issues Should Be Addressed as Part of the Proposed Regulation The Panel supports EPA’s steps toward publishing a policy statement, but there is still a need for a formal regulatory

practice of registering products to combat emerging pathog ens. Any process adopted b y the Agency should take into account the relative urgency of the need for methods, policies, and products to control pathogens. See Panel General Comments, pages 58

- 59. The Costs of the Proposed Regulation Are Significantly Un derestimated The full compliance costs of the Proposal are far greater than the costs estimated by EPA based only on new active ingredients and uses. When the compliance costs are calculated, including the costs that will be incurred b y registrants of ex isting active ingredients in registration review, the full cost was calculated by NERA in 2009 to be approximately six times the EPA estimate. That estimate is likely

low, especiall y in light of the additional costs of the expanded food definition and of exposure data and the inability to estimate costs of compl ying with non

- existing guidelines , which were not included in the EPA or NERA estimates. The Panel believes the rule is likely to impose over $100 million in costs annually and should be subject to OMB review. EPA too should be concerned about this level of impact and should repropose the regulation with a view toward reducing it. See Panel General Comments, pages 53

- 58 and Appendix K. This also is discussed in the cover letter.
Issues Related t o Possible Future Rulemaking to Ensure Compliance with the ESA Although not directl y part of the FIFRA registration data requirements for antimicrobials, EPA also solicited comments on these issues. In general, the Panel does not believe that the program EPA has in place for assessing potential impacts on endangered and threatened species is relevant to antimicrobials and their uses. Antimicrobials ty picall y are not broadcast into environmental media. To the extent that environmental exposures occur, th ey result from point

source discharges or slow release from pesticide

- containing materials. Such releases are subject to control under multiple laws and regulations. Thus, there are numerous opportunities to address antimicrobial releases to the environm ent other than through FIFRA. EPA must recognize and incorporate into its environmental risk assessment process for antimicrobials (1) reliable and relevant information and data on potential exposures, including those obtained from other regulatory

programs, and (2) the ability of other regulatory

programs to limit or mitigate exposures. I t also is important that EPA adopt sound, scientificall y valid methods for conducting environmental risk assessments for antimicrobial uses to address ESA

- related consid erations. See Pane l General Comments, Appendix M.Steven Bradbury , Ph.D. and Joan Harrigan

- Farrelly

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- Section
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- Section Analysis In addition and with specific reference to the above general issues, the Panel provided detailed specific comments on the individual sections of the proposed rule. The follow ing are key comments but do not fully summarize the extensive discussions. Scope of the Proposal. Given the statutory and regulatory

definitions of uses that are or are not included in the definition of a pesticide, generally , or an antimicrobial pestici de, specifically , questions remain about whether some of the uses described in this Proposal, in fact, are uses of antimicrobial pesticides subject to this regulation. S ee Panel Comments at Appendix A. Use Patterns in the Regulation . The purported use p atterns identified in this proposed regulation are descriptions of product t ypes rather than use categories or use patterns. The purpose of use patterns within a data requirement regulation is very clear. Based on the experience, considering these produc t t ypes as use patterns has not been useful in defining data requirements. An alternate proposal was made for use patterns for antimicrobial pesticides that better address the purpose of use patterns in a data requirement regulation. Clear definition of the use patterns needs to be part of the regulation to minimize misunderstanding. Further, there is a critical need for the development appropriate guidance to link specific use sites on product labels to the use pattern that determines the data requireme nts. The Panel’s alternate proposal was carried through all alternate proposals for data requirements. See Panel General Comments, p ages 6 and 25, and Appendix B Product Chemistry Data Requirements . The Agency has not explained why the product chemistry data requirements at 40 CFR Subpart D for conventional pesticides are fully applicable to antimicrobial pesticides. Man y antimicrobial pesticide chemistries significantl y differ from those of conventional pesticides. EPA needs to address the product ch emistry requirements for antimicrobials with those differences in mind. Panel Comments at Appendix C. Product Performance Data Requirements . The data requirements in the proposal do not reflect current Agency

practice, rely

on outdated information and r eference a set of unavailable, never published guidelines that the Agency is in the process of replacing. The various definitions proposed are inconsistent with current approaches and are, in fact, better addressed within the guidance documents that have been under development for many y ears and are currentl y undergoing public comment. In the case of product performance for public health uses, data requirements and guidance on meeting these requirements are inextricably joined. See Panel Comments, Append ix D. Toxicology Data Requirements . The Panel agrees that the Agency needs certain information to make a regulatory

judgment on proposed uses of antimicrobial pesticides under FIFRA and to determine the safet y of the pesticide chemical residues under FFD CA Section 408. The Panel has developed two alternative proposals intended to provide clearer instructions to registrants taking into account the specific considerations and applicability of these types of requirements for antimicrobial pesticides and to incorporate appropriate tiering to avoid unnecessary testingSteven Bradbury , Ph.D. and Joan Harrigan

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- and generation of redundant data. In addition, the Panel reiterates its strong recommendation that the Agency

explicitly

incorporate integrative approaches to testing, as well as to the developm ent of appropriate guidance on tiering data requirements to estimated exposures in a scientifically defensible manner, including threshold s of toxicological concerns concept . The first proposal attempts to fully incorporate the new science for determinati on of toxicology testing. The Agency

has a unique opportunity to propose regulations that are consistent with current science and permit sufficient flexibility to continue to move the science forward. The Panel strongl y recommends consideration be given to incorporating this first proposal. The Panel also is concerned that the Proposal does not include a policy or guidance to address the methods of assessing products which do not result in sy stemic toxicity but which are corrosive or severe irritants at the point of dosing. Panel General Comments, pages 29

- 30, and Appendix E

. Ecological Effects Data Requirements . Any proposed requirement for nontarget organism data for antimicrobial pesticides must be tailored to antimicrobial pesticides. Further, the requirement must dictate which uses of those pesticides pose sufficient potential for environmental exposure that assessment of effects on nontargets under FIFRA is needed. The proposed rule does not include either of these critical components. Ultimate ly , it is important to clearl y identify when potential environmental exposures may be relevant or not, and then to clearly identify what data are needed to assess the potential risks of such effects, avoiding unnecessary animal testing or development of data. The Panel offers alternate proposals for these, with detailed explanation, and further addresses the critically important need to tier requirements and to relate the requirements to the need for a risk assessment. See Panel General Comments, pages 28 , 42

- 44 and Appendix F

. Human Exposure Data Requirements . The Panel supports the conduct of exposure monitoring studies for antimicrobial applications. But the Panel also encourages EPA to avail itself of other sources of data that would be useful in enhancing the Agency ’s understanding of exposures to antimicrobials. Occupational conditions for antimicrobial applicators are very different than those for most agricultural workers and EPA should not apply the same assumptions and approaches to both. Fur

ther, EPA should consider OSHA regulation in determining whether another lay er of regulation is appropriate. The criteria triggering and the appropriate guidance for these data requirements for applicator and post application exposure are incomplete, inco nsistent and/or not relevant to antimicrobial pesticides. The Panel has proposed alternatives and identified areas where further discussions and clarity are needed before these requirements should be finalized. See Panel General Comments, pages 42

- 44 and Appendix G

. Environmental Fate Data Requirements . First, any proposed requirement for environmental fate data for antimicrobial pesticides must clearl y identify what antimicrobial pesticides are and which uses of those pesticides pose sufficient potenti al for environmental exposure that assessment under FIFRA is needed. In both cases, the proposed rule is lacking. Next, in proposing these data requirements for antimicrobial pesticides, the Agency must take into consideration the requirements of FIFRA S ection 3(h). The arbitrary assignment of product ty pes to high or low exposure is not adequate. The Panel proposed and explained alternative approaches that include the criticall y important tiering of requirements based on potentialSteven Bradbury , Ph.D. and Joan Harrigan

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- exposure and the need for risk assessment. In particular, the excessive data requirements for indoor use antimicrobials compared to other pesticides is questioned, as are the requirements associated with disposal of pesticides when disposal is regulated under other statutes. The lack of guidelines to testing and unknown relevance for antimicrobial chemistries is addressed. See Panel General Comments, pages 27, 39

- 44 and Appendix H. Residue Chemistry Data Requirements . With respect to data requirements for residue chemistry , any

proposed requirement must first clearl y identify what antimicrobial pesticides are, and what uses of those pesticides are subject to regulation under FFDCA 408. EPA has authority to establish residue requirements only for these uses. Uses of antimi crobials that fall under FFDCA 409 or other statutes are not subject to these residue regulations. In sum, the proposed rule is confusing and does not provide clarit y on the scope of the residue data requirements. The proposed rule contains numerous inap plicable requirements and inappropriate test notes for some antimicrobial applications. The Panel provided and explained an alternative tiered approach that addresses the concerns identified in the proposal. See Panel Comments, Appendix I

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