June 17, 2011

Dr. Steven Bradbury

Director, Office of Pesticide Programs

Ms. Joan Harrigan-Farrelly

Director, Antimicrobials Division

United States Environmental Protection Agency

Ariel Rios Building 

1200 Pennsylvania Avenue, NW 

Mail Code: 7501P 

Washington, DC  20460

Re:  ACC Biocides Panel/CSPA Follow-Up Regarding Issues with Proposed
158W

Dear Dr. Bradbury and Ms. Harrigan-Farrelly:

I am writing on behalf of the American Chemistry Council Biocides Panel
(ACC or the Panel) and the Consumer Specialty Products Association
(CSPA) (together the associations) to thank you and your OPP colleagues
for meeting with representatives of the two associations on May 17.  We
very much appreciated your taking the time to discuss the regulated
community’s concerns regarding the 158W proposal.  

We are writing to follow up on the meeting and provide you with more
complete information on the issues the Panel and CSPA consider most
important.  This letter and its attachments, as well as the items we
presented at the meeting, are premised upon or reference the
associations’ written comments on the Agency’s proposed Part 158W
rule.  Therefore, we request that you include this letter and its
attachments in the docket for this matter (EPA-HQ-OPP-2008-0110).

As explained at the meeting, the Panel and CSPA believe the issues
raised in our comments are so serious that the rule should be
re-proposed after EPA addresses these issues.  The two associations and
their members undertook an unprecedented effort to respond thoughtfully
and responsibly to the 158W proposal.  On April 6, 2009, the Panel
submitted a 66-page principal comment document, plus specific appendices
to address key issues and an economic analysis prepared by an expert
consulting organization NERA.  These comments express the Panel’s
comprehensive views on the issues with the proposal.  On April 6, 2009,
CSPA submitted 20 pages of comments, as well as supporting the Panel’s
comments.  In general, the Comments explain the reasons the 158W
Proposal was not sufficiently mature to progress to a final regulation
following the comment period.  Rather, so many questions and issues
required addressing that the Panel and CSPA concluded the proposal must
be re-issued for comment before being finalized.

The Panel’s concerns with the Proposal were so serious, that we made
multiple efforts to summarize our concerns in writing, explain them to
the Agency in person and offer to work on non-rulemaking projects that
would assist in allowing EPA to eventually issue a workable final
regulation.  Attachment 1 to this letter is a summary of many of the
most critical issues identified and explained in the Panel’s Comments
and during the subsequent meetings with OPP.  The summary contains
references to specific pages in the Comments addressing the issues,
where appropriate.  The Panel and CSPA urge you to carefully review this
summary and, if possible, their complete Comments, and then evaluate how
the issues raised are to be addressed by the Agency.  The associations
remain concerned that a final regulation, which does not make
substantial modifications to the approaches in the Proposal, may well be
unworkable and result in resources being wasted by both EPA and the
regulated community.  Moreover, finalizing such a rule, without
re-proposal, would deprive stakeholders of adequate notice and
opportunity to comment on significant portions of the eventual
regulation.

The associations respectfully submit that re-proposal of the Part 158W
data requirements is especially timely in light of the commands of
President Obama’s Executive Order 13563, “Improving Regulation and
Regulatory Review,” issued on January 18, 2011:

“Our regulatory system must protect public health, welfare, safety,
and our environment while promoting economic growth, innovation,
competitiveness, and job creation.  It must be based on the best
available science.  It must allow for public participation and an open
exchange of ideas.  It must promote predictability and reduce
uncertainty.  It must identify and use the best, most innovative and
least burdensome tools for achieving regulatory ends.  It must take into
account benefits and costs, both quantitative and qualitative.”

For the reasons summarized below, the Agency’s proposed Part 158W rule
will not meet the requirements of Executive Order 13563 – it will not
promote predictability and reduce uncertainty.

A.  Need for Re-proposal to Account for Developments since the Original
Proposal

During the two-and-a-half years since the Proposal was published,
additional information has become available which should be considered
in developing any final regulation.  Two principal examples are
summarized below.

Expansion of the Scope of “Food Contact” Analysis 

As the Panel points out in its Comments, the Proposal does not clearly
articulate any standards for determining what uses triggers a food
analysis.  It has become apparent since the Proposal was issued that the
Agency will interpret this regulation to vastly increase the number of
antimicrobials regulated as food use.  This raises issues concerning the
clarity of the Proposal.

  

Equally important, EPA’s economic analysis does not even attempt to
address the increase in the burden on registrants and applicants that
this expansion of the need for “food contact” approvals will cause. 
The burden will fall on a large number of active ingredients, increasing
the costs of registration as much as tenfold, from a “non-food”
package that might cost in the hundreds of thousands of dollars, to a
“food” data package that includes long-term studies and will cost
millions of dollars.

Beyond the burden on active ingredients, EPA must consider the huge
burden this expansion will impose on inert ingredients.  By expanding
the scope of uses requiring “food” review, EPA would effectively be
requiring tolerance petitions for an unknown number of inert ingredients
that would be impacted by a change in classification from non-food to
food use.  Industry sources estimate there are at least 900 fragrance
components that would require tolerances and there are likely many more
inert ingredients with other functions in formulations that also will
require tolerances.   In addition, there would be significant
transaction costs associated with the inevitable reformulation that
would occur as currently registered products are converted to food-use
status.  The Agency has not made any effort to estimate the additional
costs of studies or the reformulation transaction costs, but they would
be significant for both industry and the Agency, and must be addressed.

	Costs of Exposure Monitoring Studies

In the proposed 158W regulation, EPA estimated that a single dermal
exposure monitoring would cost $125,000 and that an inhalation exposure
study would cost $78,000, for a total of $203,000.  However, since the
Proposal, the Panel has now conducted several exposure monitoring
studies that are compliant with EPA’s regulation at 40 CFR Part 26 and
have undergone both internal EPA review and HSRB review.  A combined
dermal and inhalation exposure monitoring study that meets these
requirements averages $1.8 million.  This is well over an order of
magnitude increase in the cost estimate EPA used in its economic
analysis.  In addition, depending on use patterns of a registered or to
be registered pesticide, EPA will be asking registrants to provide
exposure data for one or more of potential 19 exposure scenarios.  The
Panel did not include any cost for these studies in the economic impact
analysis performed by NERA.  The increased costs to comply with human
subjects protection requirements may increase the cost of each
antimicrobial active ingredient registration, whether new or existing,
into the millions of dollars.  This dramatic increase in the burden on
registrants was not considered by EPA, but must be.

Similarly, the Panel cannot estimate the burdens on the Agency
associated with its reviews and interaction with the HSRB.  Nonetheless,
such activities require significant Agency resources.  Clearly, the
figures used in EPA’s analysis do not reflect the burdens that are
associated with the actual costs of conducting exposure monitoring
studies that meet Agency regulations.

B.  Follow-Up on Issues Discussed at the Meeting

During the May 17 meeting, there was significant discussion on the
following three issues raised in the Panel’s comments:

Non-Final and Inapplicable Guidelines

EPA/FDA Jurisdiction

Economic Impact of the Regulation

In addition to the description in the attached summary, the following
provides some additional specific information.

	Non-Final and Inapplicable Guidelines

At the meeting, the Panel and CSPA identified guidelines that are not
final, not available, or inapplicable to antimicrobials.  The Panel and
CSPA remain very concerned about the great number of guidelines that are
referred to in the proposal that are not available in final, usable
form.  We discuss these issues in Panel comments at pages 16-20.  To
ensure OPP has current information, we have prepared updated materials
identifying guidelines that are not available and examples of those that
are inapplicable.  These are included here as Attachment 2 (inapplicable
guidelines) and Attachment 3 (missing guidelines).  For example, the
Panel’s comments point out that there are no product performance
guidelines for textiles, and that the entire 850 series was proposed in
1996 and never finalized.  FIFRA requires EPA to issue test guidelines
and the Agency has adopted a process, including public comment, for
doing so.  The Proposal even stated in four instances that relevant
guidelines will be issued before the 158W rule is finalized.  These
guidelines should all be issued through that process before being
referred to in a regulation.  Similarly, the terrestrial and aquatic
metabolism studies (OPPTS 835.4100 through 835.4400) are based on
guidelines that refer specifically to agricultural uses, referring, for
example, to crop and non-crop areas.  There is inadequate guidance to
apply these to antimicrobials.  

EPA/FDA Jurisdiction

As we also mentioned at the meeting, the 158W Proposal does not
acknowledge the statutory division of jurisdiction with FDA over
antimicrobials with food contact uses, leading to duplicative and
potentially inconsistent agency reviews.  See ACC Comments at pp. 31-39.
 EPA does not have the authority under either FIFRA or FFDCA to review
or change the terms of an FDA food additive approval.  However, in the
preamble to the proposed 158W, EPA asserts that it can require
antimicrobial pesticides with only 409 food uses to meet the
requirements of FFDCA 408.  For example, EPA asserts that “additional
studies are needed even for the lower exposures for which FDA
historically would not have required data.”  In effect, EPA is
asserting that the scope of FFDCA 408 includes all antimicrobial
pesticides.  This position is contrary to EPA policies and practices
regarding conventional pesticides and biopesticides, and EPA has failed
to provide any basis for its new position.  See ACC Comments at page 35.

Under this interpretation, EPA will re-review and approve the same
chemicals for the same uses that FDA already has cleared, require
extensive additional data for its reviews, and subject all uses of
pesticides to the FFDCA safety standard regardless of whether any food
uses subject to Section 408 exist.  This creates a host of practical
problems, including waste of government resources, potential for
inconsistent decisions, waste of regulated parties’ resources, and
deterrence of applications for new generation products.  Therefore,
clarification is needed on the regulation of food-use antimicrobial
pesticides before this rule is finalized.  

Economic Impact of the Regulation

EPA’s economic impact analysis, which was published with the proposal,
was premised on an incomplete view of the true costs of the regulation. 
The Panel submitted an analysis prepared by NERA, which indicates costs
in the approximately $90 million per year range -- far greater than
EPA’s estimates.  See ACC Comments at pp. 53-58 and Appendix J.  In
addition, as described above (see sections Expansion of Scope of “Food
Contact” Analysis and Costs for Exposure Monitoring Studies) and
unknown costs and the risk of applicants and registrants having to
repeat rejected studies because of non-existing guidelines, it has
become clear that additional costs of the regulation will increase the
cost of the rule even beyond the NERA estimates.  Thus, the actual
annual costs of the proposal are likely to exceed the $100 million
threshold for “economically significant” rules under EO 12866.

 * * * *

We hope this information is helpful to you in deciding how to proceed
with respect to the 40 CFR Part 158 Subpart W Proposal.  For the reasons
set forth above, in its Comments and in the attached documents, the
Panel and CSPA urge you to develop a mature and responsive document and
re-propose it for public comment.  The Panel and CSPA also urge OPP to
promptly remedy the shortcomings in the infrastructure necessary to
support any antimicrobials data requirements regulation, including
publishing mammalian and ecological risk assessment guidance, issuing
test guidelines through the process the Agency has established, and
taking a fresh and fair look at the economic impact of the provisions in
any final regulation.  The Panel and CSPA are willing to devote
resources to working with EPA in these areas, in a transparent public
process.

Sincerely,

Hasmukh C. Shah, Ph.D.	Brigid Klein

Manager, Biocides Panel	Vice President and General Counsel

American Chemistry Council	Consumer Specialty Products Association

Attachments

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

June 17, 2011

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