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EPARulemakingEPA-HQ-OPP-2003-0132

Human Testing; Proposed Plan and Description of Review Process.

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Dec 27, 2023
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closed 7309d ago
American Chemistry Council filings
4

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American Chemistry Council filed 4 comments on this docket between Aug 5, 2003 and Jan 6, 2006. 93 other organizations filed here. The comment window closed 7309d ago.

What American Chemistry Council filed (4)

Jan 6, 2006· Comment submitted by Michael P. Walls, Managing Director, American Chemistry Council· EPA-HQ-OPP-2003-0132-0620

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Dec 13, 2005· Comments submitted by the American Chemistry Council· EPA-HQ-OPP-2003-0132-0303

Public Information & Records Integrity Branch (7502C) Office of Pesticide Programs Environmental Protection Agency 1200 Pennsylvania Ave., NW Washington, D.C. 20460-0001 Re:Protections for Subjects in Human Research Docket No. OPP-2003-0132, 70 Fed. Reg. 53838 (Sept. 12, 2005) Dear Sir or Madam: These comments on EPA?s proposed rule are submitted on behalf of the Biocides Panel (Panel), a self-funded CHEMSTAR panel within the American Chemistry Council, which represents basic manufacturers and formulators of antimicrobial pesticide products. These products are used in industrial applications to prevent fouling, improve energy efficiency and protect equipment and material inputs; and as material preservatives; wood and antifouling treatments; public health antimicrobials, including drinking water treatments, products to eliminate or control pathogens in the food supply, hospital sanitizers and disinfectants; and consumer products. The Biocides Panel Member Companies are listed in Attachment A. INTRODUCTION The Panel, through its Antimicrobial Exposure Assessment Task Force II (AEATF or Task Force), is currently developing human exposure data that are intended to cover the full range of application methods and use patterns for the various antimicrobial product categories regulated by EPA. As a result of this work, which will involve at least 19 separate research studies and take approximately five years to complete, both the Panel and the Task Force have particular interest in the proposed rule. In addition, Panel members formulate products that are used in industrial, institutional and residential settings that result in regular skin contact. Routinely, critical information regarding the safety of these products is provided through the conduct of patch testing with human subjects to determine the potential for sensitization and irritation. Again, the Panel has significant interest in the potential impact of the proposed regulation on these types of testing. These are examples of the types of testing in which the Panel and its members engage. In every instance, the testing is conducted to quantify exposures or to assure the safety of products. These tests are not intended to elicit any toxic or adverse effect and none are anticipated. The Panel supports the position of the American Chemistry Council (ACC) that endorses application of the Common Rule to all third-party research using human subjects, whether for pesticide or other regulatory purposes. The Panel?s comments draw attention to several particular issues on which ACC in its comments expressed concern. In this way, the Panel hopes to demonstrate where EPA should consider changes to its proposal. DESCRIPTION OF AEATF RESEARCH PROGRAM The AEATF is conducting research to measure the unit inhalation and dermal exposures to antimicrobials over the broad range of application methods and use patterns in which these products are used. These data are required in support of registration and reregistration eligibility. The studies are to be conducted in accordance with EPA Pesticide Assessment 875 Guidelines covering applicator and post-application exposure assessment. The studies are all being conducted in compliance with EPA?s Good Laboratory Practice Standards regulations. The Task Force is working closely with EPA scientists, as well as scientists from other regulatory jurisdictions, to design the studies to enhance their scientific utility and rigor. Moreover, the antimicrobials used for the research are registered for the use patterns and application methods being studied. The research is to be conducted in compliance with the EPA-approved labeling on the products. Because the products are to be used in compliance with all EPA-approved directions, application rates and mandated precautions, there is no reasonable expectation that adverse effects will occur. In many instances, the studies will be conducted under simulated…

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May 9, 2005· Comments from the American Chemistry Council· EPA-HQ-OPP-2003-0132-0233

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Aug 5, 2003· Comments from the American Chemistry Council Re: Human Testing; Advance Notice of Proposed Rulemaking· EPA-HQ-OPP-2003-0132-0132

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Abstract

For Further Information Contact: William Jordan, Mail Code (7506C), (703) 305-1049

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Co-filers (93)

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Human Testing; Proposed Plan and Description of Review Process. (EPA) — American Chemistry Council | OpenPolis