June 17, 2011

Attachment 1

Summary of Key Issues 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).

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 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 evaluates conventional pesticides. This is based on scientific principles and extensive 

external collaboration with independent experts, including the FIFIRA Scientific Advisory Panel. 

The Panel is aware of no written policies or guidance documents for conducting 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-by-case basis. This 

results in significant variation in the manner in which compounds with similar uses are 

evaluated. Additionally, 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 clarity as to 

what data requirements 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 by the lack of toxicological or 

environmental risk assessment guidance. 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 

 

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Since that time, the Panel has met with EPA several times to present selected aspects of those comments:

 October 1, 2009: Discussion papers 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 10, 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

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adopted by 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 implements data requirements, 

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 asserting 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 incorporated 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 annual 

production volume of a material preservative would be discharged down the drain, which is not 

even justified as a screening level analysis. EPA should make a priority of developing 

substantiated environmental risk assessment approaches that can be presumptively 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 particularly 

important as EPA begins to perform Endangered Species Act assessments on pesticides. See 

Panel Comments, Appendices G, H and M.

The Proposal Does Not Provide Adequate Guidance to the Regulated Community

One consequence of the uncertainty about risk assessment approaches for antimicrobial use 

scenarios is that the Proposal leaves too many decisions to a case-by-case determination by EPA, 

instead of providing scientifically based criteria for determining data requirements. This 

effectively compromises the ability of registrants to anticipate requirements 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 applicability of data 

requirements. See Panel General Comments, pages 8-12 and Appendix K.

Final Testing Guidelines Are Not Available for Many Data Requirements

In many 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. See 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 considerations. 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 provides no substantiation for 

the assignment of these categories, some of which the Panel cannot understand. Exposure levels 

cannot simply be assumed based on product types. Data requirements must be tied to a clear 

need in the risk assessment process and should be tiered to identify what is needed under specific 

circumstances. See 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 between 

FIFRA 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 food.” In the preamble to the conventional pesticide proposal, 

EPA appropriately 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 

requirement Proposal eliminated any reference to the requirement for a tolerance or exemption or 

indeed any 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 supported by law or sound policy. Panel General Comments, pages 33-39.

The Proposal Does Not Recognize the Division of Jurisdiction between EPA and FDA

The Proposal does not clearly 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 by EPA pursuant to FFDCA section 408. Instead, it appears to assert 

EPA’s jurisdiction over antimicrobial food uses where the statutory scheme provides jurisdiction 

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 analyses. In addition, the lack of any effort to coordinate with FDA to develop a 

coordinated approach to regulation in this area likely will give rise to serious implementation 

issues. See Panel General Comments, pages 31-33
Steven Bradbury, Ph.D. and Joan Harrigan-Farrelly

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The Proposal Does Not Provide Clear Delineation of Food Uses of Antimicrobial 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 Proposal 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. Yet 

the economic impact is not considered anywhere in the Proposal or supporting documentation. 

See Panel General Comments, pages 37-39 and in Appendices A and I.

Potential Exposures to Antimicrobials Differ from Other Pesticides and Require Different 

Approaches

FIFRA § 3(h), requires EPA to regulate antimicrobial pesticides after considering the degree of 

risk posed by various antimicrobial uses. However, the Proposal’s data requirements fail to take 

account of the extent to which antimicrobials differ from other pesticides. Both human and 

environmental exposures to antimicrobial uses are regulated under other environmental, and

health and safety 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 any appropriately structured 

data requirement proposal for exposures of all types. EPA should review and analyze these data 

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 fully supports the generation 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 

essential to refine and improve the quality 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 activity relationship analyses, in vitro approaches, or computational 

toxicology. The 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 amended 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 develop 
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appropriate guidance for the use of alternative approaches to 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. See 

Panel General Comments, pages 45-50.

Emerging 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 pathogens. Any process 

adopted by 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 Underestimated

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 by registrants of existing 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, especially in light of the additional costs of the expanded food 

definition and of exposure data and the inability to estimate costs of complying 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 to Possible Future Rulemaking to Ensure Compliance with the ESA

Although not directly 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 typically are not broadcast into 

environmental media. To the extent that environmental exposures occur, they result from pointsource 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 environment 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. It also is important that EPA adopt sound, scientifically valid methods for conducting 

environmental risk assessments for antimicrobial uses to address ESA-related considerations.

See Panel General Comments, Appendix M.
Steven Bradbury, Ph.D. and Joan Harrigan-Farrelly

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Section-by-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 following 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 pesticide, specifically,

questions remain about whether some of the uses described in this Proposal, in fact, are uses of 

antimicrobial pesticides subject to this regulation. See Panel Comments at Appendix A.

Use Patterns in the Regulation. The purported use patterns identified in this proposed 

regulation are descriptions of product types 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 product types 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 requirements. The Panel’s alternate proposal 

was carried through all alternate proposals for data requirements. See Panel General Comments, 

pages 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. Many antimicrobial pesticide chemistries significantly

differ from those of conventional pesticides. EPA needs to address the product chemistry

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 reference 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 years and are currently 

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, Appendix 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 safety of the pesticide chemical residues under FFDCA 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 testing 
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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 

development of appropriate guidance on tiering data requirements to estimated exposures in a 

scientifically defensible manner, including thresholds of toxicological concerns concept. The 

first proposal attempts to fully incorporate the new science for determination 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 strongly 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 systemic 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. Ultimately, it is important to clearly 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. Further, EPA should consider OSHA regulation in determining whether 

another layer of regulation is appropriate. The criteria triggering and the appropriate guidance 

for these data requirements for applicator and post application exposure are incomplete, 

inconsistent 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 clearly identify what antimicrobial pesticides are and 

which uses of those pesticides pose sufficient potential 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 Section 3(h). The arbitrary assignment of product 

types to high or low exposure is not adequate. The Panel proposed and explained alternative 

approaches that include the critically important tiering of requirements based on potential 
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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 clearly 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 antimicrobials 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 clarity on the scope of the residue data requirements. The 

proposed rule contains numerous inapplicable 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.