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).  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 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.

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

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
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 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
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.

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 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 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.

 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

Attachment 1

June 17, 2011

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