U.S. Food and Drug Administration
US Customs Service
February 2000


Enhancing the Safety of Imported Foods

Comments on Public Meetings


A.        PUBLIC MEETINGS:

2/10/00: Irvine, CA
2/17/00: Washington, DC

On February 10 and again on February 17, 2000, the US Food and Drug Administration and US Customs Service held public meetings to present and discuss the agencies' plan to implement the presidential directive to Enhance the Safety of Imported Foods. The first meeting was held in Irvine, CA and the second was held in Washington, DC. Importers, industry associations, private laboratories, customsbrokers, foreign embassies, foreign governments, and other US government agencies were represented at the meetings; over 150 individuals participated in Irvine, CA and over 110 participated in Washington DC.

The discussions centered on the six objectives of the plan: 1) to prevent distribution of imported unsafe food by requiring importers with a history of illegal distribution, misrepresentation, or substitution to hold shipments under secured storage until release by FDA; 2) destruction of foods refused for significant public health reasons; 3) requiring marking, prior to exportation, of foods refused for safety reasons; 4) set standards for the use of private laboratories by establishing requirements for importers and other persons who use sample collection services and/or private laboratories to demonstrate compliance with FDA laws and by establishing requirements and standards for the collection and analysis of samples; 5) increase the amount of the bond posted for imported foods when necessary to deter premature and illegal entry into the US; and 6) enhance enforcement by means of assessment of civil monetary penalties by Customs in cooperation with FDA. A copy of the slides used for discussion at the public meetings is available at www.foodsafety.gov/~dms/fs-impo2.html.

Comments, concerns, and recommendations were presented to the agencies during the breakout sessions of the public meetings. These comments were subsequently presented to the plenary session at the close of the public meetings. The comments were captured by breakout session. The breakout sessions were: A) Secured Storage, Bonds, and Civil Monetary Penalties; B) Destruction and Marking; and C) Standards for Private Laboratories. Each comment is annotated by the location of the public meeting at which the comment was presented.

GENERAL COMMENTS:

Participants in both public meetings provided general comments regarding the agencies' proposed plans:

  1. The agencies should anticipate the impact of equivalency on the procedures.
  2. The procedures should be transparent; specific criteria should be established and everyone should know what they are and when the procedures become effective.
  3. The agencies should recognize the economic impact of new procedures.
  4. The agencies should assure timely decisions that impact the procedures.

SECURED STORAGE:

  1. The agencies plan to propose the use of bonded warehouses for secured storage. Participants recommended that the agencies allow for use of alternative sources of secured storage such as Foreign Trade Zones or General Order warehouses. (Irvine)
  2. The agencies plan to include identification of importers subject to secured storage procedures in an Import Alert. The publication of the proposed Import Alert was encouraged. (Washington DC)
  3. The agencies were asked to explicitly state that a customsbroker who accurately transmits information provided by the client, and is not a party to substitution or misdeclaration, would not be considered to be subject to secured storage consideration. (Irvine)
  4. The agencies plan to consider an importer subject to secured storage procedures when he fails to redeliver twice in a 6-month period. Participants recommended that that criteria only apply when the food not redelivered represents a serious health hazard. (Washington DC)
  5. The agencies plan to consider an importer subject to secured storage procedures when he misdeclares information at the time of entry or subsequent to refusal. Participants recommended that the misdeclaration be considered as a criterion for secured storage only if the misdeclared information is material; i.e. it impacts FDA's admissibility decision. (Washington DC)
  6. The participants asked that the agencies be aware that importers subject to secured storage procedures may either change the name or identity of the importing business or stop importing for a period of 12 months. (Irvine)

DESTRUCTION:

  1. Participants recommended that the importer should be allowed to return refused shipments (of foods that represent a public health risk) directly to the responsible party. (Irvine and Washington DC)
  2. Participants recommended that FDA take into account another country's standards and not cause the destruction of a food that another country deems safe to eat. (Washington DC)
  3. Participants expressed their concern that destruction procedures (as proposed) are an indiscriminate application of the intent of the presidential directive and that the behavior (distribution of unsafe imported food) should be targeted rather than the product. (Washington DC)
  4. Participants also expressed the concern that the agencies should target the intent to import an unsafe food rather than the importation of the unsafe food. (Washington DC)
  5. Participants recommended that, in some cases, FDA should allow for reconditioning after export rather than require destruction prior to export. (Washington DC)
  6. Participants recommended that FDA issue specific guidelines that identify what conditions would lead to a recommendation for seizure, forfeiture and destruction by Customs. It was urged that such guidance provide a graduated scale identifying products such as canned mushrooms with Staphylococcal enterotoxin (which cannot be reconditioned) as an example of a product most likely to be recommended for destruction. Raw shrimp contaminated with Salmonella would be the least likely to be recommended for destruction, since it can be reconditioned. (Washington DC)

MARKING (a Proposed Rule will be published for comment by FDA at a later date):

  1. FDA is drafting a proposed rule that may require marking of the shipping container prior to export of foods refused for safety reasons. Participants recommended that, in lieu of the shipping container, the cargo container be marked. (Irvine)
  2. Additionally, participants recommended that, in lieu of the shipping container, the cargo container be sealed and that FDA have a reciprocal agreement with the receiving country to examine the goods upon receipt and certify that there was no substitution, etc. (Irvine)
  3. FDA is drafting a proposed rule, which may require the mark to state "Refused U.S.". Participants recommended that the mark be more specific; the mark should identify the reason for refusal. (Washington DC)
  4. A participant recommended that, in lieu of a conspicuous mark, FDA use invisible ink to mark the packages. An invisible mark would be detectable upon re-entry but would not unduly concern the foreign customer. (Washington DC)
  5. Participants wished to alert the agencies that products so marked could be repackaged to remove the mark after exportation. (Washington DC)

SETTING STANDARDS FOR PRIVATE LABORATORIES (a Proposed Rule will be published for comment by FDA at a later date):

  1. Participants, while agreeing with the need for accreditation of laboratories, recommended that FDA becoming an accreditation body. (Irvine)
  2. Participants encouraged FDA to allow the use of private laboratories to analyze surveillance samples rather than only shipments subject to detention without physical analysis. (Irvine and Washington DC)
  3. Participants recommended that FDA also require accreditation of sample collectors and provide specific requirements for them. (Washington DC)
  4. Participants recommended that FDA establish internal timeframes to address review of private laboratory analytical submissions, audit samples, etc. Participants also recommended that special procedures be created for perishable products. (Washington DC)
  5. Participants recommended that private laboratory results not be submitted directly to the district by the laboratory. (Washington DC)

INCREASED BONDS (a Proposed Rule has been published for comment by Customs; Customs is currently reviewing the comments and will publish the final rule at a later date):

  1. Customs had included in the proposed rule a consideration of an across-the-board bond increase for all food entries. Participants recommended that the increased bond only apply to those importers subject to secure storage requirements. (Irvine and Washington DC)
  2. Participants also recommended that increased bond be required only for importers responsible for illicitly distributing imported foods that pose a significant risk to public health. (Washington DC)

CIVIL MONETARY PENALTIES:

No comments

B.        SUBMITTED TO DOCKET #00N-0120

Through 3/02/00

These comments represent input from a foreign government, several trade associations, a private laboratory and a customsbroker.

GENERAL COMMENTS

  1. The trade associations generally supported this initiative and commended the government's joint approach. One pointed out that existing statutes already provide all needed authority.
  2. The trade associations felt that some of the initiatives might unfairly and indiscriminately penalize industry and become trade barriers. They emphasized that all proposed initiatives should be limited to "problem" importers.
  3. One trade association emphasized the need for equivalency agreements, because point of entry sampling is not effective.
  4. One comment stated that USDA food products should be covered.
  5. Another comment criticized the initiatives for not dealing with mishandling of products after importation.

SPECIFIC COMMENTS

SECURED STORAGE:

  1. Limit this requirement to "bad actors."
  2. Use "secured storage" only if there are two (2) Customs violations with illnesses in a six month period; or if the importer knowingly misleads the government.
  3. Modify the criterion on "false and misleading" to add the phrase "where intended to deceive."

DESTRUCTION:

  1. Maintain the importers' legal right to re-export or recondition.
  2. The government needs to be aware of the cost implications of destruction and possible restraint of trade claims.
  3. Don't rely simply on the "Class I Recall Criteria," but consider if reconditioning is possible.
  4. Consider safety standards in other countries as an alternative to destruction.
  5. Establish an appeals process.
  6. Do not allow re-exportation of unsafe food.
  7. Customs may need money to oversee destruction.

MARKING:

  1. A mark may unduly stigmatize shipment elsewhere; use invisible ink.
  2. Agree with marking, but be flexible and allow alternate language.
  3. Include the reason for refusal in the shipping records.

STANDARDS FOR PRIVATE LABORATORIES:

  1. FDA should accredit private laboratories.
  2. FDA should accredit private laboratories using ISO 17025.
  3. FDA should permit third party accreditation.
  4. Third parties should be allowed to both collect and analyze samples.
  5. FDA should provide both guidelines and performance criteria.
  6. Accreditation is too expensive.
  7. FDA's own laboratories must meet the same recognized standards.
  8. Protocols must be developed to handle conflicting results.

INCREASE BOND:

  1. Current triple value is an adequate deterrent.
  2. Establish a Commission to evaluate bond criteria and appeals.
  3. Customs and FDA already can require a "special bond rider" to deal with "bad players."
  4. Increased bond is unneeded and restricts trade.
  5. Determining domestic value is difficult.
  6. Higher bonds are appropriate for "bad actors."

CIVIL MONETARY PENALTIES:

  1. Clear, transparent guidance is needed.
  2. Seek these penalties only if there is a "pattern" of violations.
  3. Develop guidance and an appeals process.

 


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