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Questions for the Panel on Import Tolerance Guidance

Scientific Advisory Panel (SAP) December 1997 Meeting

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) has completed its review of the Office of Pesticide Programs (OPP) policy for determination of data requirements for tolerance positions. The review was conducted in an open meeting held in Arlington, Virginia, on June 3, 1997. The meeting was chaired by Dr. Ernest E. McConnell. Other panel members present were: Dr. Janice E. Chambers (Mississippi State University); Dr. Richard Fenske (University of Washington); Dr. Robert Herrick (Harvard University); Dr. Paul Kuznesof (U.S. Food and Drug Administration); Dr. Harihara M. Mehendale (Northeast Louisiana University); Dr. Richard M. Parry, Jr. (U.S. Department of Agriculture); Dr. Stephen Saunders (Frito-Lay Corporation); Dr. Edward Stein (U.S. Department of Labor); Dr. Donald Wauchope (U.S. Department of Agriculture); Dr. Willis Wheeler (Wheeler Associates).

Public Notice of the meeting was published in the Federal Register on April 22, 1997.

Oral statements were received from:
Dr. Richard Costlow, Rohm and Haas Company
Dr. Barbara Petersen, Novigen Sciences Inc.

Written statements were received from:
American Crop Protection Association


1. Please comment on the methodology used to determine the number and location of crop field trials required for estimating appropriate tolerance levels.

The Panel finds the methodologies reasonable and agrees that the import guidance document will be a very useful step toward harmonization of standards used in international trade. The Panel believes that the guidance should be shared with the U.S. Delegation to the Codex Committee on Pesticide Residues, the North American Free Trade Agreement effort and the Organization for Economic Cooperation and Development for their comments. The development of a standardized guidance, when harmonizing internationally, promotes the exchange and use of data generated among the various countries.

A raw agricultural commodity (RAC) is a low consumption commodity if it is less than or equal to 0.05% of the diet. The commodities which cover this definition were identified in the DRES based on 1977-78 food consumption survey. Information was presented by EPA on the commodities forming a percentage of the diet. It is recommended that these data be updated as soon as possible to reflect current food consumption patterns of the U.S. population.

The Panel would like to see the wording on adherence to GLP's (or their international equivalents) made stronger to indicate that compliance to those standards is required.

2. Please comment on the criteria for limited review of residue chemistry studies when a Codex Maximum Residue Limit (MRL) has been established.

The Panel recognizes that increasing globalization of world trade and consequent international movement of agricultural commodities makes important the issue of Codex MRL's. The criteria elaborated by the Agency for a limited review of Codex MRL's seem overly conservative. The Panel suggests the Agency consider modifying this approach to recognize the extent of US participation in the establishment of MRLs. In particular there is little scientific rationale provided for using the 0.05% consumption limitations.

The Panel suggests that the Agency consider elimination of this restriction and instead develop a case-by-case policy which would accept Codex MRLs as a default position, but reserving the right to conduct a full review of the data based on the scientific merits of each case. Under such a scheme, the Agency could require any level of review necessary. If, based on the experience of the US in the development of the Codex (JMPR) MRL, there were significant scientific issues which were not adequately addressed by the JMPR then additional review would be justified. On the other hand, if the Agency believed that the Codex MRL was an accurate reflection of the underlying data and no other issues pertained, then acceptance of the MRL for limited review without restrictions based on consumption would seem more scientifically justifiable. Such a policy would give the Agency the flexibility to use available resources for maximum efficiency.


Certified as an accurate report of findings:

Larry C. Dorsey
Designated Federal Official
FIFRA/Scientific Advisory Panel

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