Comment submitted by J. Yowell, Huntsman Corp.

See attachment for comments: June 14, 2006 Office of Pesticide Programs (OPP) Regulatory Public Docket (7502C) Environmental Protection Agency 1200 Pennsylvania Ave., NW. Washington, DC 20460-0001 Re: Objections to proposed rule entitled "Inert Ingredients; Proposed Revocation of Tolerance Exemptions with Insufficient Data for Reassessment", Docket Number EPA-HQ-OPP-2006-0230 Dear Sir/Madam: We believe the Agency needs to reconsider this rule and make extensive revisions to its provisions prior to issuing a final rule solely for the purpose of meeting a mandated deadline. 1. Legal and administrative deficiencies of the proposed revocations. a. Lack of data call-in. EPA?s low-risk methodology for evaluating inert ingredients clearly spelled out the intention to issue data call-ins (DCI) for any data that might be required to satisfy tolerance reassessment. b. Lack of mechanism for protecting data that would be needed to support the exemptions. c. The Agency?s inability to provide specific data gap information for each chemistry and unwillingness to provide comments on groupings, suggested groupings and specific information requests to support such groupings. This information would be required under an official DCI action. d. The Agency?s vague statements and requests that the inert ingredient manufacturers and registrants need to propose suggested 40 CFR language for each chemistry or group as we propose them for the Agency?s approval. e. Lack of a mechanism for publication and revision/additions to the list of accepted CAS. Registry Numbers that the Agency proposes to use as the only indication of an inert ingredient being approved for use in a formulation. 2. Complexity of responding to data needs in the proposed time frame. a. Forming task forces to provide data is more complex than any other circumstance affecting a broad range or registrants and manufacturers. b. Determining precise data requirements for large number of compounds in the absence of the Agency?s predetermination of the requirements necessary even though it has conducted a ?review? of the existing data and determined that unknown data gaps exist. c. Determining representative compounds for which classes of chemistry and the compounds to be included in the class are selected then approved by EPA prior to any testing. d. Results of studies can lead to additional data needs requiring additional time and Agency approval. e. Uncertainty of timely EPA review of submitted data to meet revocation deadline. f. Flexibility must be built into the rule, clearly allowing the necessary time for industry to respond to the data needs. g. Availability of qualified laboratories and the two-year deadline may not be reasonable. There are not enough labs and not enough time to run all of the OECD 422 data being requested. 3. The lack of availability of data or the cost of generating data for particular ingredients may lead registrants to reformulate some registered pesticides using different inert ingredients. a. Reformulation requires toxicity testing, validation field testing, developing and submitting packages to EPA for approval, and review and approval of those packages by EPA, all steps in a time consuming process. b. Reformulation may require research to identify, develop, and approve new inert ingredients to replace some that are lost. c. Some currently registered pesticides will be impossible to reformulate without a particular inert that is in the revocation proposal (based on past industry experience) and those pesticides may be lost to the grower community. d. Will sufficient supplies of alternate ingredients be available to reformulate, if necessary? Suppliers are structured to meet existing inert needs, and changing to manufacture other substances to meet market demand requires time and may require capital investment and construction. 4. Affected products in commerce a. Registered pesticides using inerts currently exempt from tolerance could potentially affect products in commerce resulting in confusion in distribution of those pesticides. b. Reformulation of products and substitution of ingredients will affect the international marketing and trade in those products. 5. Economic analysis of the proposed action. a. EPA failed to provide an economic analysis an admittedly flawed premise. b. EPA still has obligation to conduct that analysis and have it reviewed by OMB in order to issue a final rule. c. Industry must provide a preliminary accounting of sources of cost to industry (producing data, business at risk, reformulating products, etc.) and ballpark estimates of amounts. d. We believe this meets the economic criteria for a major rule. 6. Correct errors and make adjustments to ease the burden of EPA and industry. a. Erroneous inclusion of ingredients that have already been declared reassessed. b. EPA should have carved out polymers for polymer exemption as it had done in previous revocation actions. c. Publication of the Agency?s assessment documents has been slow and this useful information unavailable to the public for comment. This has not been a transparent process in regard to Agency decisions and assessments. 7. Channels of trade issues, given a 2-yr time frame yet to be addressed by the Agency. a. Following 2-year period, EPA would have to go through cancellation proceedings for products containing unsupported inert ingredients. b. What to do with existing stocks of pesticides containing unsupported inert ingredients when 2 yrs expires? c. What to do with existing stocks of inert ingredients that are not supported when 2 yrs expires? Please reconsider the revocation of these tolerance exemptions. These exemptions can be issued conditionally on data submission providing the Agency time to provide appropriate guidance to the industry on what these data involve, what chemistries can be grouped and what testing needs to be completed for which members of the groupings. Thank you for your considerations. Sincerely: James Yowell Global Registration Manager