June 17, 2011

D r. 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 Washin gton, DC 20460 Re: ACC Biocides Panel /CSPA Follow

- Up Regarding Issues with Proposed 158W Dear D r. 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 appreciate d your taking the time to discuss the regulated community ’s concerns r egarding the 158W proposal. W e are writing to follow up on th e 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 me eting, 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

. T he two associations and their members undertook an unprecedented effort to respond thoughtfull y 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 analy sis 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. Ingeneral, the Comments explain the reasons the 158W Proposal was not sufficient ly 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 w ith 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 eventuall y issue a workable final r egulation. Attachment 1 to this letter is a summary of many of the most critical issues identifiedSteven Bradbury , Ph.D. and Joan Harrigan

- Farrelly

June 17, 2011 Page 2 of 5 and explained in the Panel’s C omments and during the subsequent meetings with OPP. The summary contains references to specific pages in the Comments addres sing 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 b y the Agency

. The associations remain concerned that a final regulation , which does not make substantial modifications to the approaches in the P roposal , 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 especiall y timely in light of the co mmands of President Obama’s Executive Order 13563, “Improving Regulation and Regulatory Review,” issued on January 18, 2011: “Our regulatory

s ys tem must protect public health, welfare, safety, and our environment while promoting economic growth, innovatio n, 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 i nnovative and least burdensome tools for achieving regulatory

ends. Itmust 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 uncertaint y. A. Need for Re

- proposal to Account for Developments since the Original Proposal During the two

- and

- a - half y ears since the Proposal was published, additional information has become available which should be considered in developing an y final regulation. Two principal examples are summarized below. Expansion of the Scope of “Food Contact” Anal ys is As the Panel points out in its C omments , the Proposal does not clearl y articulate any standards for determining what uses trigger s a food anal ys is. It has become apparent since the Proposal was issued that the Agency will interpret this regulation to vastl y increase the number of antimicrobials regulated as food use. This rai ses issues concerning the clarity of the Propos al. Equally important, EPA’s economic anal ys is 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 cau se. The burden will fall on a large number of active ingredients, increasing the costs of registration as much as ten fold, from a “non

- food” package that might cost in the hundreds of thousands of dollars, to a “food” data package that includes long

- term s tudies and will cost millions of dollars

.Steven Bradbury , Ph.D. and Joan Harrigan

- Farrelly

June 17, 2011 Page 3 of 5

Be yond 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 b y 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 ther e are likely man y 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 register ed 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. C osts 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 anal ys is. In addition, depending on use patterns of a registered or to be registered pesticide, EPA will be asking r egistrants to provide exposure data for one o r more of potential 19 exposure scenarios. The Panel did not include an y cost for these studies in the economic impact analysis performed by NERA. The increased costs to comply with human subjects protection r equirements 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 b y EPA , but must be. Similarly , the Pane l cannot estimate the burdens on the Agency associated with its reviews and interaction with the HSRB. Nonetheless, such activities require significant Agency resources. Clearl y, the figures used in EPA’s analysis do not reflect the burdens that are asso ciated 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 thre e issues raised in the Panel’s c omments:

- Non

- Final and Inapplicable Guidelines

- EPA/FDA Jurisdiction

- Economic Impact of the RegulationSteven 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 Inapplicab le 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 proposa l that are not available in final, usable form. We discuss these issues in Panel c omments 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 s eries 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 b efore 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 acknowle dge 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 an y 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 pro blems, 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 antim icrobial 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 anal ys is, which was published with the proposal, was premised on an incomplete view of the true costs of the regulation. The Panel submitted an anal ys is prepared b y NERA, which indicates costs in the approximately $90 million per y ear 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” Anal ysis 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 wil l increase the cost of the rule even beyond the NERA estimates. Thus, the actual annual costs of the proposal are likel y to exceed the $100 million threshold for “economically significant” rules under EO 12866.

* * * * We hope this information is helpf ul 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

- pro pose 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 guid ance, 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 thes e areas, in a transparent public process. Sincerel y, Hasmukh C. Shah, Ph.D. Brigid Klein Manager, Biocides Panel Vice President and General Counsel American Chemistry

Council Consumer Specialty Products Association Attachment s