LETTERS ON CURRENT ISSUES
[Text only of letters sent from the Commerce Committee Democrats]

Michael A. Friedman, M.D.
Lead Deputy Commissioner for Operations
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857

Dear Dr. Friedman:

The Committee on Commerce has had a longstanding interest in the safety of food imported into the United States, and in the ability of the Food and Drug Administration (FDA) to protect food fully. My concern has been heightened by recent reports of outbreaks of food-borne illness associated with E coli-contaminated carrots from Peru, cyclospora contaminated raspberries from Guatemala, and hepatitis contaminated strawberries from Mexico.

In 1992, the General Accounting Office (GAO) reported that one-third of adulterated shipments of imported food products detected by FDA were neither destroyed nor re-exported. Instead, this adulterated food entered U.S. commerce and, presumably, was sold to American consumers.

In 1993, GAO testified before the Subcommittee on Commerce, Consumer Protection, and Competitiveness concerning Mexico's use of pesticides on fresh fruits and vegetables imported into the United States. In that testimony, GAO said that "Mexico has no government agency responsible for enforcing and monitoring pesticide residues ...." and that "FDA's programs provide only limited protection against public exposure to prohibited pesticide residues on imported foods."

I have serious concerns that Mexico and many other countries from which we import fresh fruit, vegetables, and other food products continue to lack the necessary monitoring and enforcement capability to ensure that foods they export to the U.S. meet appropriate safety standards. At the same time, it is not clear that deficiencies in these foreign countries can be offset by FDA, in light of budget and resource constraints that even stretch the agency's ability to enforce safety standards on food produced here in the United States. In addition, the U.S. is now bound by obligations under international agreements that further affect the enforcement of U.S. standards on imported food.

To assist me in understanding more clearly the role of FDA in ensuring the safety of imported food, the agency's ability to fulfill its responsibilities in that area, and the potential or actual impact of international agreements, I would appreciate your responses to the enclosed questions. Please respond by Wednesday, January 7, 1998. Thank you for your cooperation and assistance.

Sincerely,

JOHN D. DINGELL
RANKING MEMBER

Enclosure

cc: The Honorable Thomas J. Bliley, Jr.
Chairman, Committee on Commerce

1. (a) Does the FDA have methods and procedures for detecting the various types of microbial, viral, and parasitic contamination of fresh fruits and vegetables that are imported into the United States? Please describe those methods and procedures.

   (b) How much is FDA spending in the current fiscal year, and how much has been spent in each of the last four fiscal years, to develop and/or improve the technology and testing capability needed to detect microbial, viral, and parasitic contamination of fresh fruits and vegetables?

   (c) What does FDA expect to spend in each of the next three fiscal years to develop and/or improve the technology and testing capability needed to detect microbial, viral, and parasitic contamination of fresh fruits and vegetables?

2. (a) How many shipments of fresh fruits and vegetables imported into the United States has FDA identified in each of the past seven years as having microbial, viral, or parasitic contamination?

   (b) What were the ten countries with the highest incidence of microbial, viral, or parasitic contaminated fresh fruit and vegetable shipments to the United States in each of the past seven years?

3. Are there tolerances for microbial, viral, and parasitic contamination of fresh fruits and vegetables, and if not, what is being done by FDA or other federal agencies to develop such tolerances?

4. In recent years, food-borne illness and death has been caused by E coli-contaminated carrots from Peru, cyclospora-contaminated raspberries from Guatemala, and hepatitis-contaminated strawberries from Mexico. What enforcement actions has the FDA taken against the growers and countries that shipped these contaminated fruits and vegetables to the United States?

5. The Food, Drug, and Cosmetic Act prohibits adulterated food from moving in interstate commerce.

   (a) Does the FDA consider fresh fruits and vegetables to be adulterated if they are imported into the United States with microbial, viral, or parasitic contaminants?

   (b) If fresh fruits and vegetables were to be detected as being adulterated upon their importation, does the Food, Drug, and Cosmetic Act provide adequate authority for the FDA to stop their movement in interstate commerce, and, if not, what additional authority is needed?

6. The Administration's new initiative to ensure the safety of imported and domestic fruits and vegetables would expand the number of FDA inspectors to inspect and monitor growers in foreign countries.

   (a) How many FDA inspectors currently inspect and monitor growers in foreign countries?

   (b) In which countries are inspections conducted?

   (c) How many times in each of the last 4 years have such foreign inspections been carried out?

   (d) How many growers were inspected by FDA over this four-year period?

   (e) Under the Administration's new initiative, how many new inspectors would be added to the current inspection force? How frequently will FDA inspect foreign growers?

7. According to the Administration's description of its new food safety initiative, "[t]he President will send legislation to Congress that will require the FDA to halt imports of fruits, vegetables and other food products from any foreign country with food safety systems and standards that are not on par with those of the United States." Under this policy, does the FDA expect to halt imports from any country which does not inspect to ensure that government-established standards are enforced with regard to the processes used to produce fruits, vegetables, and other food products, as well as the products themselves?

8. On February 18, 1993, the General Accounting Office (GAO) gave important testimony on the use of pesticides on fresh fruits and vegetables that were grown in Mexico and imported into the United States (copy of testimony is attached). That testimony was given before the Commerce Committee's Subcommittee on Commerce, Consumer Protection, and Competitiveness which was chaired by former Congresswoman Cardiss Collins of Illinois. GAO raised a number of concerns in that testimony, and I have a number of questions that I would like FDA to answer concerning issues raised by GAO.

   (a) With regard to Mexico's regulation of pesticide use on fresh fruits and vegetables, GAO had the following to say in its testimony, "The principal limitation of the Mexican monitoring system is that the government does no monitoring itself ... Instead, the private sector -- Mexican and multinational companies and state and national agricultural growers' associations -- has assumed responsibility for monitoring exports. Companies and associations will test their food only as needed."[emphasis added] Is the GAO's characterization of the situation in Mexico still accurate? If so, would the fact that the Mexican government, unlike the United States government, fails to do any monitoring itself mean that fruit and vegetable imports from Mexico could be halted by the FDA under the Administration's new food safety policy, since Mexico's food safety systems and standards "are not on par" with those of the United States?

   (b) The 1993 GAO testimony, stated: "Mexico has no government agency responsible for enforcing and monitoring pesticide residues." Is this statement still true?

   (c) GAO said in its testimony that the Mexican government is establishing a national laboratory system to test pesticide residue levels. At the time of GAO's testimony, Mexico had 5 functioning laboratories to test pesticide residue levels and had plans to add 6 more labs. One of the 5 labs that was functioning at the time of the testimony was owned by the Mexican government and that government-owned lab set the standards for the other labs in the system. Does FDA have any information concerning the number of labs currently operating in Mexico and Mexico's plans to establish additional labs?

   (d) The GAO testimony also reported "a long-term trend whereby importers were disregarding U.S. laws prohibiting the distribution of adulterated foods." The GAO testimony stated, "We found that one-third of the adulterated shipments detected by FDA were not returned for destruction or export and presumably reached U.S. grocery shelves. This problem existed because some importers who were repeatedly caught with adulterated foods chose to pay the relatively low damages assessed by the U.S. Customs Service rather than destroy or return the food."

   (i) What is the percentage of adulterated shipments of imported fruits and vegetables detected by FDA that were not returned for destruction or export in each of the last 4 years?
   (ii) Does the FDA agree with the GAO that adulterated produce is not destroyed or returned, partly because the penalties for failure to destroy or return a shipment are too low?
   (iii) GAO refers to "importers who were repeatedly caught with adulterated foods." How many such "repeat offenders" are there and what actions has the FDA taken to prevent such repeat offenders from continuing to bring adulterated produce into the United States?

   (e) The testimony stated that "Agricultural imports from Mexico account for nearly one-half of all the fresh and frozen fruits and vegetables exported to the United States from all countries." What are the top ten countries that export fruits and vegetables to the United States? What percentage of total imports of fruits and vegetables is attributable to each of these countries? What percentage of total U.S. consumption of fruits and vegetables is attributable to each of these countries?

   (f) GAO's testimony stated that, "FDA's testing shows that the Mexican violation rate is generally higher than the violation rate for domestic produce" [i.e., for pesticide residues on produce]. What has been the violation rate for Mexican grown produce in each of the last 4 years, and how does it compare with the violation rate for U.S. grown produce in each of those years?

   (g) GAO's testimony stated that a working group of U.S. (FDA) and Mexican officials was established in 1991 for the purpose of resolving differences in pesticide tolerances, or standards, between Mexico and the United States. These pesticide tolerance differences fall into three groups. In the first group, there are 58 food-use pesticides which have tolerances in both countries, but not for the same commodities. In the second group, GAO found 17 pesticides that have food-use tolerances in Mexico but none in the United States. The third group includes pesticides that have tolerances in both countries for the same commodities but at different levels.

   GAO's testimony stated that "the resolution of tolerance differences is critically important...While the working group has set broad priorities for the types of differences to address first, it does not have a long-term strategy for mitigating all differences in tolerances, such as those in the third category, and those new tolerances that will occur or be canceled because of continuing changes in the universe of pesticides. Thus, unless the working group addresses all of the differences, it is unlikely that resolution will be reached for all pesticide tolerances between the United States and Mexico."

   (i) Does the U.S.-Mexico working group on pesticide tolerances still exist? Who are its members? How many times has it met in each of the last 4 years? When is its next meeting scheduled? For how many of the pesticides in the first group and second group has the working group resolved differences between the United States and Mexico as to tolerance levels and the commodities to which they may apply?
   (ii) Has the working group established a long-term strategy for resolving all differences in U.S. and Mexican tolerances? If so, over what time period are all such differences to be resolved? What progress has been achieved so far in resolving tolerance differences?
   (iii) Have working groups been established to resolve similar differences between the U.S. and other major produce exporting countries? If so, what are the countries with which working groups have been established and what is the status of their work?
   (iv) Does the FDA agree with the GAO that resolving tolerance differences is "critically important" to protecting the safety of produce imported into the U.S.?

   (h) The GAO testimony stated that about 1 percent of imported produce shipments were being sampled each year by FDA inspectors. Has the percentage of produce imports sampled by FDA declined, remained the same, or has it increased since 1993? How many visual inspections of imported fruits and vegetables has FDA conducted in each of the last 6 years, and how many laboratory tests on imported produce shipments were conducted in each of the last 6 years?

   (i) In 1993, there were 13 FDA inspectors at the two primary entry points into the United States for Mexican fruit and vegetable exports---Dallas, Texas, and Los Angeles, California. How many FDA inspectors have there been at the Dallas and Los Angeles entry points to inspect imported produce in each of the last 5 years?

   (j) The GAO testimony stated that "FDA relied on analytical test methods which can detect less than half of the pesticides potentially available in world markets." Is this statement still true, or is the FDA able to detect a larger number of the pesticides potentially available today than was the case in 1993?

   (k) The GAO testimony also stated that "FDA was limited in its ability to better target testing because it lacked knowledge about which pesticides were being used in foreign countries." What has the FDA done to increase its knowledge of pesticides being used in foreign countries? Does the FDA believe its enforcement efforts would be enhanced if produce imported into the U.S. were required to be labeled identifying the pesticides with which the produce has been treated?

9. The 1993 GAO testimony stated, "Since the Mexican government does not monitor residue levels for exported produce, U.S. inspections are all the more important." Has the FDA increased its inspections at the border or in Mexico since 1993?

10. For each year since the North American Free Trade Agreement (NAFTA) went into effect, please report:

    (a) the number of inspections of imported Mexican fruits and vegetables that the FDA has conducted to determine compliance with U.S. pesticide and other requirements;

    (b) the number of violations that these inspections have identified; and

    (c) the number of inspections and violations FDA conducted in each of the 5 years prior to NAFTA's taking effect.

11. Since NAFTA took effect, has the number of FDA inspections and the overall quality of FDA's inspection of Mexican produce imported into the United States improved, remained the same, or declined [please give a detailed explanation and justification for your answer]?

12. The 1993 GAO testimony stated that "because of inefficiencies and resource limitations, FDA's programs provide only limited protection against public exposure to prohibited pesticide residues on imported foods."

    (a) Does FDA believe this statement to be true today?

    (b) How would the FDA describe its limitations in providing protection against public exposure to prohibited pesticide residues on imported foods?

    (c) Would the imposition of a user fee on shipments of imported produce reduce the resource limitations under which GAO said the FDA operates?

13. How will voluntary "Good Agricultural Practice/Good Manufacturing Practice" standards for fruits and vegetables aid FDA in preventing contaminated produce from being imported into the United States? Without mandatory standards, how can FDA be certain that foreign growers are producing safe products?

14. Currently, food importers must meet the same standards as domestic food processors. However, vague terms, like "equivalent standards" and "appropriate levels of protection" can be used to change and weaken this requirement. Will the Administration's legislation require foreign food processors to meet the same standards as our domestic producers must meet, or will foreign food processors be permitted to meet standards that are "equivalent" to ours?

15. How many laboratory tests is FDA currently doing to detect pathogens in imported fruits and vegetables? What have been the results of these tests?
    
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