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

June 17, 2011

Page 2 of 5

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

June 17, 2011

Page 3 of 5

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

June 17, 2011

Page 4 of 5

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

June 17, 2011

Page 5 of 5

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