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EPA Pesticide Program Updates: March 4, 2002


Pesticide Program Update from EPA's Office of Pesticide Programs, March 4, 2002

IN THIS UPDATE:


NAIN Closes Its Doors

The National Antimicrobial Information Network (NAIN), the companion telephone helpline to the National Pesticide Information Center (NPIC), has announced that it will terminate its services, effective March 31, 2002. First established in 1995 as the Antimicrobial Complaint System, NAIN was a key source for information on antimicrobial pesticides and pesticide products, via a telephone helpline and web-based services.

Until March 31, NAIN will continue to provide this information. You may contact NAIN on weekdays, 7:30 a.m . - 4:30 p.m.. (Pacific Time), at 1-800-447-6349; website address: or by e-mail: nain@ace.orst.edu. After March 31, EPA's Antimicrobials Division (AD) will provide information about antimicrobial pesticides. Interested parties may contact David Liem (703-305-1284) or Michael Hardy (703-308-6432) directly.


Guidance Document on Determination of the Appropriate FQPA Safety Factor(s) in Tolerance Assessment

EPA's Office of Pesticide Programs (OPP) has recently released a document describing the Agency's policy for implementation of a section in the Food Quality Protection Act of 1996 (FQPA) that directs the Agency to heighten protection for infants and children in setting pesticide tolerance levels. This document, the "Guidance Document on Determination of the Appropriate FQPA Safety Factor in Tolerance Assessment," refers to the section of FQPA that requires an additional safety factor, or greater protection, for infants and children. As well, this document is intended to increase the public's and regulated entities' understanding of OPP actions and provide guidance to the Agency's risk assessors to facilitate the implementation of the children's safety factor provision.

On August 3, 1996, FQPA significantly amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). To assure protection from unacceptable pesticide exposures, FQPA established a stringent health-based standard for pesticide residues in food. This statute establishes an additional tenfold margin of safety to protect infants and children, taking into account the potential for pre- and post -natal toxicity and the completeness of the toxicology and exposure databases. This guidance document refers to the section of the statute that authorizes EPA to replace this tenfold "FQPA safety factor" with a different factor only if the resulting margin would be safe for infants and children.

In preparing this guidance document, EPA has comments from the public, an expert panel of scientists under the FIFRA Scientific Advisory Panel (SAP), and other external parties. This guidance was developed as part of a process developed in conjunction with the Tolerance Reassessment Advisory Committee (TRAC) to ensure that EPA's politics related to implementing FQPA are transparent and open to public participation.

This guidance takes into account approaches described in two papers developed by the "Toxicology and Exposure Working Groups of the Agency 10X Task Force," a group established in March 1998 to assist in addressing the general considerations regarding the use of the tenfold margin of safety. Those papers addressed the role of toxicology and exposure data for risks to children's health from pesticide exposure. EPA also sought comment on two other papers reflecting the guidance and procedures used by OPP in assessing the data available and applying the tenfold FQPA safety factor. The Agency announced the availability of a draft of these four documents in 1999 and invited the public to comment; these papers are incorporated in and replaced by this guidance. The Federal Register notice for the current document is available electronically. The paper is available on PDF.


Draft Guidance on Consideration of the FQPA and Other Uncertainty Factors in Cumulative Risk Assessment Available for Comment

On January 28, 2002, EPA released draft guidance on applying the Food Quality Protection Act (FQPA) safety factor in cumulative risk assessments. EPA will accept comments until April 29, 2002, according to procedures described in the Federal Register notice. The draft guidance will serve as a guide to risk assessors in the Office of Pesticide Programs to facilitate consistent implementation of the FQPA children's safety factor provision in cumulative risk assessment and to increase public understanding of cumulative risk assessments by regulated entities and the public.

The draft guidance discusses the differences between single-chemical risk assessments and cumulative risk assessments that are relevant to application of both traditional uncertainty factors and the FQPA safety factor. It also provides an analytical framework for consideration of these factors and describes methods risk assessors would use in evaluating the applicability of the FQPA factor. Key issues to be reviewed are completeness of the toxicity database, potential pre- and post - natal toxicity, and adequacy of the exposure database.

The draft guidance is available (PDF) on EPA's web site, as is the Federal Register notice.


Shimberg Appointed EPA Associate Assistant Administrator (Note to Correspondents 2/27/02)

Steven J. Shimberg, who has over 20 years experience dealing with environmental matters, including 18 years in federal service, has been appointed as EPA Associate Assistant Administrator for Enforcement and Compliance Assurance.

From 1997 to 2001, Shimberg was Vice-President, Federal and International Affairs, at the National Wildlife Federation in Washington, D.C., with responsibilities that included strategic planning for conservation advocacy and education programs and management of the Federation's Washington office.

Shimberg, 49, served in key staff positions in the U.S. Senate from 1981 to 1997, including being Staff Director and Chief Counsel of the Committee on Environment and Public Works and counsel to the late Senator John H. Chafee (R-RI). During that time, he was active in international treaty negotiations, including those leading to the Montreal Protocol on ozone depletion substances, and he played a central role in strengthening numerous environmental laws.

From 1978 to 1981, he was a prosecuting attorney in the Land and Natural Resources division of the U.S. Department of Justice.

A native of Jericho, N.Y., Shimberg is an alumnus of the State University of New York at Buffalo and the Duke University School of Law.


President Bush Intends to Nominate Suarez to be EPA Assistant Administrator (Note to Correspondents 2/27/02)

President Bush has announced his intention to nominate John Peter Suarez to be EPA Assistant Administrator for Enforcement and Compliance Assurance.

Suarez has served as the Director of the New Jersey Division of Gaming Enforcement since 1999 and previously was Assistant Counsel to then-Governor Christie Whitman. In 1998, he was Special Assistant to the New Jersey Director of Criminal Justice. From 1992 to 1998, he was Assistant U.S. Attorney in the District of New Jersey.

Suarez is an alumnus of Tufts University and the University of Pennsylvania Law School.


Note: For general questions on pesticides and pesticide poisoning prevention, contact the National Pesticide Telecommunications Network (NPTN), toll-free, at: 1-800-858-7378, by e-mail at nptn@ace.orst.edu, or by visiting their Web site.

For information about ongoing activities in the Office of Pesticide Programs, visit OPPs home page.

Or call or write OPP directly at:

Communication Services Branch
Office of Pesticide Programs (7506C)
US Environmental Protection Agency
Ariel Rios Building
1200 Pennsylvania Avenue, NW
Washington, DC 20004-2403
703-305-5017




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