U.S. Food and Drug Administration
February 11, 1999

Dear Colleague:

The enclosed January 29, 1999 letter from the Food and Drug Administration (FDA) to Directorate General XXIV (DG-XXIV) of the European Commission may be of interest to your organization. The letter provides FDA's response to recent DG-XXIV recommendations pertaining to FDA's monitoring programs for chemical residues in animal-derived foods and to U.S. certification procedures for such foods exported from the United States to the European Union (EU).

In July 1998, an inspection team from DG-XXIV visited the United States to examine certain aspects of the U.S. regulatory system for control of "chemical residues" in animal-derived foods. Chemical residues include those that may arise from veterinary drugs, pesticides, environmental contaminants and natural toxins. Animal-derived foods include meat and poultry, seafood, dairy products, eggs, game meat and honey. The DG-XXIV team met with the U.S. Department of Agriculture (USDA) to discuss U.S. regulations and residue control programs for meat and poultry and with FDA to discuss residue control for the other commodities. In October of 1998, DG-XXIV issued a report of its findings. The report and FDA's and USDA's comments on a draft version of the report are available from DG-XXIV's internet site:
< http://europa.eu.int/comm/dg24/health/vi/reports/vi_rep_usa_01_en.html>.

In its report, DG-XXIV recommends that FDA initiate new residue monitoring programs or restructure existing programs to achieve consistency with EU requirements. It also recommends that FDA, USDA, and the National Marine Fisheries Service (NMFS) modify the existing procedures for issuance of required certificates to EU Member States. For the reasons stated in the enclosed letter, FDA does not believe that it is necessary or appropriate for the agency to initiate new residue monitoring programs or to modify existing U.S. certificate issuance procedures in order to meet specific EU requirements for such activities.

However, FDA remains ready to work cooperatively with the European Commission under the auspices of the equivalence provision of Article 4 of the World Trade Organization's (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) to address and resolve the issues raised in the DG-XXIV report. FDA believes that discussion of chemical residues and other food safety attributes within the equivalence context of the SPS agreement will provide a positive and productive mechanism for each side to assess the food safety system of the other with respect to animal-derived foods.

FDA is aware that these issues may be of particular interest to some sectors of the U.S. food industry, especially those involved with export of certain animal-derived foods to the EU. FDA and the other U.S. government offices working on this activity are prepared to meet with interested parties, as necessary, to discuss the issues. Those who wish to discuss the enclosed letter and/or to arrange to meet on the issues should contact Dr. John W. Jones of FDA's Center for Food Safety and Applied Nutrition by phone at 202-205-4311 or by fax at 202-401-2893.

January 29, 1999

Mr. Horst Reichenbach
Director General
European Commission, Directorate General-XXIV
Consumer Policy and Consumer Health Protection
Rue de la Loi 200
B-1049 Brussels, Belgium

Dear Mr. Reichenbach:

I am writing to follow up on my November 17, 1998 letter to you in which I provided FDA's interim response to DG-XXIV's recommendations pertaining to FDA's residue monitoring programs for animal-derived foods and to U.S. certification procedures for such foods exported from the United States to the European Union. This letter also provides FDA's response to the Aide-Memoire on these issues which the European Commission (the Commission) delivered to the U.S. Mission in Brussels on November 18.

The Commission makes two general recommendations: (1) that FDA modify the current U.S. procedures in place to provide Member States of the European Union with certificates of export for certain animal-derived foods; and (2) that FDA or other U.S. agencies implement new chemical residue monitoring programs or modify existing programs to accommodate requirements of Commission Directive 96/23/EC and related directives. FDA has given careful consideration to these recommendations, taking into account, particularly, how the recommendations fit into FDA's current and future risk-based, food safety programs.

First, I will address the certification issues. As you know, in accordance with EU requirements, the United States currently provides EU Member States with various certificates attesting to the safety of animal-derived foods produced in this country and exported to Europe. The U.S. Department of Agriculture (USDA) provides certificates for meat and poultry and FDA, in cooperation with the National Marine Fisheries Service (NMFS) of the Department of Commerce, and the Agricultural Marketing Service (AMS) and Food Safety and Inspection Service (FSIS) of USDA, issues certificates or sanctions issuance of certificates for seafood, dairy products and game meat, respectively.

Currently, FDA and NMFS each issue certificates for seafood, an arrangement to which the Commission agreed previously. The Commission now recommends that FDA assume sole responsibility for issuance of seafood certificates and that FDA and/or other agencies conduct more frequent inspections of producing firms and more frequent audits of the firms' documentation supporting the veracity of the certificates.

FDA believes that the current certificate issuance procedures for seafood are effective and resource efficient.. The NMFS operates its inspection program in accordance with a written agreement with FDA, under which it applies all FDA safety standards during its inspections and refers any unresolved compliance problems to FDA for appropriate action. The inspection regimen that underlies the certificates, most notably, sound HACCP regulations coupled with periodic inspections, enables FDA and NMFS to issue valid and meaningful certificates. We believe that our current approach for issuance of certificates to the EU Member States is as effective as the EU system, which itself rests upon cooperative action and mutual reliance activities among the Member States and three Directorates General with responsibility for food. Nevertheless, to provide additional assurance to the Commission on this issue, FDA and NMFS commit to meet at regular intervals to review the certificate system, particularly with respect to the adequacy of future audit frequency, and to identification of any deficiencies in supporting documentation for the certificates.

Regarding inspection frequency, FDA has enhanced the frequency of inspection for seafood processors as part of the U.S. national mandatory seafood HACCP program. FDA is not aware of the reasoning or scientific basis for concerns with the current U.S. inspection frequency expressed by the Commission. The frequency of inspection in the United States may or may not differ from that of EU Member States, however, the issue is whether the U.S. inspection frequency is adequate to verify that processors are meeting their responsibility to produce safe food. We believe strongly that it is. The intensity of the inspection program necessary to accomplish this objective may vary from country to country, depending upon the conditions in that country and other safeguards of the country's regulatory and general legal systems. FDA welcomes further elaboration by the Commission on this issue. However, we are confident that the current inspectional effort for seafood is sufficient to enable the United States to attest to the safety of U.S.-produced seafood exported to the EU.

The Commission also recommends that FDA modify existing procedures for U.S. issuance of certificates for dairy products. Currently, FDA authorizes AMS to issue certificates attesting to compliance of U.S.-produced dairy products with EU requirements for somatic cell and plate counts, and to equivalence with EU requirements for other public health attributes under FDA's responsibility. With regard to the public health attestation, FDA provides AMS with a list of firms which have been inspected by FDA or state authorities and have been found to be in substantial compliance with all applicable FDA regulations bearing on safety and sanitation. AMS also conducts verification inspections of dairy firms that include examination for compliance with EU requirements for somatic cell and plate counts. AMS issues shipment-specific certificates to the EU Member States based on the list of firms found to be in compliance with U.S. regulations. The Commission agreed previously to this arrangement, but now recommends that FDA assume sole responsibility for issuance of certificates, that the producing firms be inspected more frequently, and that the certificates' supporting documentation be audited more frequently.

FDA and AMS will continue to work closely to ensure that the types and frequency of inspections and documentation necessary to support the certificates are sufficient. The agencies have reviewed and will continue to review the certificate program periodically and will implement any improvements we believe to be necessary to ensure the program's credibility. We will be pleased to provide the Commission with information on these reviews and on any program changes. FDA believes that the current certificate issuance procedures are effective and resource efficient. The current inspection frequency of listed dairy firms is adequate to support certificate issuance. Therefore, we do not believe that it is necessary to modify the basic approach. AMS will continue to issue the certificates based on FDA, state and AMS inspections. FDA notes that the EU system also rests upon a cooperative approach among various government entities.

Now, let me address the chemical residue monitoring issues. The Commission recommends that FDA implement new monitoring programs or enhance existing programs for aquaculture products, whole eggs, game meat and honey according to the requirements of Commission directives. The Commission recommends, particularly, that FDA implement monitoring activities for veterinary drug residues in these commodities.

First, let me address the issues mentioned in the Aide-Memoire relative to residue monitoring for whole eggs and animal feeds. FDA notes that the U.S. export volume to Europe of whole shell eggs intended for direct consumption is negligible due to the current EU requirement that whole eggs be sold at retail level within 21 days of production. Therefore, the issue of U.S. implementation of a chemical residue monitoring program specifically for whole shell eggs exported to Europe is not germane to the present situation. Nonetheless, FDA recognizes that the whole egg export situation may change in the future and the agency remains ready to discuss the issue further with the Commission, as warranted. We note also that the Aide-Memoire recommends that USDA include monitoring of animal feeds for mycotoxins as part of its monitoring regimen. This activity falls under FDA's responsibilities. The agency conducts an extensive monitoring program for animal feeds, which includes monitoring for mycotoxins. In addition, FDA oversees an even larger state monitoring activity for mycotoxins in animal feeds. We can discuss details of these activities with your technical staffs as necessary.

As we stated in our response to DG-XXIV's draft report, FDA recognizes that targeted monitoring programs for chemical residues may be an appropriate component of an overall regulatory strategy for control of dietary exposure to these substances. In this context, FDA has previously conducted monitoring activities for selected chemical residues in these products. For example, the agency conducted a monitoring program for selected veterinary drug residues in aquaculture products as recently as 1997. FDA currently conducts a monitoring program for pesticide residues that includes coverage of aquaculture products, eggs and honey. These programs are, and have been historically, directed toward general surveillance to determine the overall residue exposure for specific chemicals, residue levels in a particular commodity, or toward enforcement to address an identified residue problem. These programs have demonstrated over many years that chemical residues in U.S.-produced foods are not excessive and are well within applicable U.S. tolerances. Consequently, FDA has made a conscious decision to effect residue control primarily through implementation of preventive measures in food production, rather than through large scale end-product testing. Stringent regulatory and enforcement tools such as strict HACCP regulations and on-farm veterinary drug usage controls contribute to FDA's ability to minimize dietary exposure to chemical residues. FDA is not aware of compelling information indicating the need, from a public health perspective, for a major U.S. residue monitoring program along the lines contemplated in Commission Directives 96/23/EC and 97/747/EC. Although the agency will continue to verify that preventive controls are working properly to minimize residue levels, at this time, FDA does not believe that initiating specific monitoring programs for aquaculture products, whole eggs, game meat and honey as recommended by the Commission is warranted.

FDA is amenable to working with the Commission to alleviate any concerns it may have about the safety of U.S.-produced animal-derived foods exported to Europe. In this regard, the agency plans to gather information from available sources on veterinary drug residues in the particular commodities of interest to the Commission, including any residue data the Commission may wish to share on drug residues in these commodities, particularly in those commodities originating from the United States. Depending on the information gathered in this activity, FDA may elect to conduct targeted monitoring or enforcement activities to address particular situations. FDA commits to conduct regulatory follow up on any compelling evidence that suggests the presence of drug residues in U.S.-produced commodities in excess of U.S. tolerances. We will keep you apprised of this activity.

In addition, FDA also wishes to work with the Commission on technical issues relating to analytical methods for veterinary drug residues in aquaculture products and other commodities. One limiting factor for effective monitoring of veterinary drugs in aquaculture products, for example, is the lack of regulatory methods of analysis. If the Commission concurs, FDA will initiate an information exchange activity with the Commission's technical staffs on analytical methodology for veterinary drug residues in aquaculture seafood. FDA is also quite willing to accommodate visits by Commission residue chemistry experts to FDA analytical chemistry research facilities and to send FDA residue chemistry experts to visit EU reference laboratories to discuss development of regulatory methods and their application in residue monitoring programs. Such technical exchanges, if sustained, would enable each side to gain a better understanding of the residue control systems of the other. We hope that the Commission is receptive to such exchanges.

Finally, the Aide-Memoire indicates that the Commission (DG-XXIV) wishes to conduct "an inspection" in May or June of 1999 to verify FDA's implementation of the Commission's recommendations pertaining to dairy products, seafood, eggs, game meat and honey, and to conduct a comprehensive assessment of the U.S. seafood safety system. FDA wishes to avoid the confusion that occurred during the DG-XXIV visit last July. We want to be clear that the United States is prepared to accommodate a "seafood safety system audit" in May or June. As I stated in my October 14, 1998 letter to you, FDA and the other federal and state agencies involved in the U.S. seafood safety system will be pleased to receive the DG-XXIV delegation under the auspices of the equivalence provision of Article 4 of the WTO SPS Agreement.

Therefore, we hope to receive the Commission's plans for the seafood audit as soon as possible to enable preparations to proceed for the May/June activity. We would also like to take the opportunity of the May/June seafood audit to continue discussion of some of the other technical issues pertaining to residue monitoring programs for the other commodities, and to discuss how to proceed with future equivalence assessments. FDA does not intend to undergo "an inspection" to determine our compliance with Commission directives.

Thank you again for your willingness to work with FDA and other U.S. agencies on these very important issues. I understand fully that the issues are complex and that the solutions are not always straightforward. Nevertheless, I believe that with FDA's and the Commission's willingness to work cooperatively toward a mutually acceptable and workable approach, we can resolve the issues and enhance public health protection for both European and American consumers.

Cc:

The Honorable Vernon Weaver, United States Ambassador to the European Community Mr. Guy Legras, Director General, Directorate General VI, European Commission