| Comment Record|
Mr. James Skiles ||
2002-08-30 14:29:03 |
Grocery Manufacturers of America, Inc. |
Food Industry |
| Comments for FDA General |
1. General Comments
August 30, 2002
Dockets Management Branch
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20852
Re: Docket No. 02N-0275
Enclosed please find the Grocery Manufacturers of America's preliminary comments and suggestions to the Food and Drug Administration concerning implementation of Section 303 (administrative detention) of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
James H. Skiles
Vice President, General Counsel
U.S. Food and Drug Administration
Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Docket No. 02N-0275
COMMENTS OF THE GROCERY MANUFACTURERS OF AMERICA, INC.
August 30, 2002
The Grocery Manufacturers of America, Inc. (GMA) appreciates the opportunity to provide preliminary comments and suggestions to the Food and Drug Administration concerning implementation of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act or the Act) (PL 107-188). GMA is the world's largest association of food, beverage and consumer product companies. With U.S. sales of more than $460 billion, GMA members employ more than 2.5 million workers in all 50 states. The organization applies legal, scientific and political expertise from its member companies to vital food, nutrition and public policy issues affecting the industry. Led by a board of 42 Chief Executive Officers, GMA speaks for food and consumer product manufacturers at the state, federal and international levels on legislative and regulatory issues. The association also leads efforts to increase productivity, efficiency and growth in the food, beverage and consumer products industry.
FDA is to be commended for the orderly, open, and efficient manner in which it has approached the implementation of the Bioterrorism Act. As FDA well knows, the time period provided by the Congress for the adoption of regulations required to implement various provisions of the Act is only 18 months. The regulations that FDA is required to adopt--on establishment registration, recordkeeping, and prior notice of food imports--have the potential to disrupt seriously the flow of food in commerce. It is, therefore, critically important that FDA's process for the development of proposed regulations, consideration of comments, and adoption of final regulations continue to provide for maximum public input and that FDA remain fully committed to the issuance of final regulations within the time period provided in the Bioterrorism Act. GMA intends to cooperate fully with FDA to achieve timely and appropriate implementation of the Act.
These comments address section 303 of the Bioterrorism Act, which authorizes FDA to detain articles of food in certain limited circumstances. GMA has also filed comments section 305 (establishment registration), section 306 (recordkeeping), and 307 (prior notice of food imports).
Section 303 of the Bioterrorism Act provides FDA with the authority to detain an article of food in limited circumstances where FDA possesses substantial information to support a conclusion that the food to be detained presents a serious threat of adverse health consequences or death to humans or animals (serious threat). The Congress provided this new authority to FDA -and fashioned it narrowly - with full awareness of the fact that most states have detention authority. It is appropriate to conclude, therefore, that the Congress intended for the authority to be used sparingly and only in the case of the most serious threats to the safety of the food supply.
1. Standard for Detention
The standard in the Bioterrorism Act for detention is high: credible evidence or information indicating thatů[the] article [of food] presents a serious threat of adverse health consequences or death to humans or animals. As in the case of records access under section 414, the standard for detention requires that FDA possess concrete and probative evidence to support the conclusion that the food to be detained presents a serious threat to consumers. Hearsay, innuendo, and anonymous allegations are insufficient to provide credible evidence. The plain meaning of the term credible evidence is proof (evidence) that offers reasonable grounds for being believed (credible). The regulations should make clear that the criteria for a detention are high and that FDA will not detain food without solid and reliable evidence.
2. Procedural Protections
The regulations to implement the detention authority should embody numerous provisions to protect the rights of persons whose products may be detained. Some of these provisions are required by the Act, while others would be just sound practice.
a. Notice of Detention
When food is detained, FDA should immediately provide a written notice of the detention to: (1) the person in custody of the food; and (2) if the food is not in the custody of the manufacturer, then to the manufacturer. It is important that the notice be provided both to the custodian of the food (a warehouse, for example) and to the manufacturer when the food is not in the manufacturer's custody. First, the manufacturer may be in the best position to determine what actions should be taken with regard to the food (and other food of the same type or from the same lot that is still in the custody of the manufacturer). Second, the manufacturer is likely to receive inquiries from the media about the detention and cannot reasonably be expected to respond to the inquiries while ignorant of the detention.
The written notice of detention should describe the article of food that has been detained and the quantity of the food, its location, and briefly the basis for the detention.
b. Opportunity for Hearing to Appeal Detention Order/Hearing Process
The Bioterrorism Act provides for the opportunity to appeal a detention with the Secretary of Health and Human Services. Under the Act, an informal hearing is to be held and a decision on the appeal made within five days.
A written notice of detention should be accompanied by a written explanation of the appeal right and information that will enable a person entitled to appeal to understand how to file such an appeal.
When an appeal is filed, FDA should promptly provide the appellant with a detailed statement of the basis for the detention and any data and information that support the conclusion that the standard in the Act for detention has been met. The appellant should be entitled to file a written statement of its position. The informal hearing should be, at the option of the appellant in person or by telephone. The findings of the Secretary after the hearing should be set forth in writing since the Act provides that the Secretary's decision is final agency action under the Administrative Procedures Act, which is judicially reviewable.
c. Expedition of Seizure or Injunction Acts Following a Detention
The Act requires that the FDA provide by regulation for expedited procedures for the filing of a seizure action or request for injunction when the food that has been detained is perishable. It is important in all cases in which food is detained that the agency act with dispatch in effectuating a seizure or in seeking an injunction and FDA should commit in its regulations to promptly file for seizure or injunction whenever food is detained and not only in the case of perishable foods.
d. Security of Detained Article
The Act provides that food that is detained may be moved to a secure facility. FDA's regulations should ensure that if detained food is moved to a secure facility, the food will be maintained under temperature, humidity, and other conditions that will maintain the value and quality of the food.
The authority to detain food under the Bioterrorism Act is limited and requires that FDA have a high degree of confidence that the food possesses a serious threat to public health. FDA's regulations should provide for procedural safeguards to protect against the arbitrary or unsupported detention and to facilitate the filing and consideration of appeals of detention orders. FDA's procedures should also provide for the expeditious filing of seizure or injunction actions after a detention.