European Commission Asks For A Risk Assessment Of The Fda "prior Notice" Regulations

[CRE Staff]

The regulations deal with the prior notice requirements dealing with imported food under the Bioterroism and Preparedness and Response Act.

"The European Communities fully share the US aim to provide measures to ensure an effective control of the food and feed chain, namely deriving from the terrorist threat. It is noted, also, that there is no risk assessment provided in relation to the proposed measures as requested by the SPS Agreement. The basis put forward is that it is “a low probability, but potentially high cost event”. The US should provide such a risk assessment as requested by the SPS Agreement both to justify the proposed measures and to ensure that any potential risks are addressed in an effective and proportionate manner. The European Communities consider that it will prove counter-productive to the objective of the measures if they are unduly bureaucratic and burdensome."

CRE is considering contacting the EC on this important matter. We bring up this point because the resultant risk assessment would have to meet the requirements of the Data Quality Act, which CRE was the initial proponent. Comments?

"New Guidelines Open U.S. Data To Challenge The Center for Regulatory Effectiveness, which characterizes itself as a regulatory watchdog group that is supported by business and trade associations, was the impetus behind the new law..."

The Washington Post, October 1, 2002

[admin]

Food Companies Fighting Bioterror Regs

CSPI Says Rules Should Protect Food Supply, Not Pamper Industry

WASHINGTON—The Food and Drug Administration (FDA) should take maximum advantage of its new authority to guard against intentional contamination of food, according to the nonprofit food-safety watchdog, the Center for Science in the Public Interest (CSPI). As the FDA prepares to release two more proposed regulations required by last year’s anti-bioterrorism legislation, CSPI said that food-industry complaints about the new rules are trivial in comparison to the prospect of a terrorist attack via the food supply.

“It’s unseemly that the food industry is complaining about regulations designed to protect Americans from bioterrorism,” said CSPI food safety director Caroline Smith DeWaal. “It took the tragedy of September 11 to get the airline industry to install stronger cockpit doors. Why wait around for an attack on the food supply when we can focus on preventing one in the first place?”

In January, FDA published draft regulations requiring domestic and foreign food plants to register with the agency and requiring food importers to give FDA advance notice before shipments arrive at ports or border crossings. Soon, the FDA is scheduled to publish a proposed rule that would let the agency detain shipments that it believes to be contaminated, as well as a rule requiring companies to keep better records. The food industry has claimed that the record-keeping and prior-notice provisions in particular are too burdensome, while CSPI maintains that the Bioterrorism Act intended for FDA to be able to trace contaminated food either back to its source or forward to its ultimate destination.

“We’ve already seen how many people can be sickened or killed by unintentional contamination of the food supply, particularly from imported produce,” said DeWaal, who pointed to food-poisoning outbreaks linked to raspberries from Guatemala and cantaloupes from Mexico. “It doesn’t take a genius to see how much sickness and death an intentional attack could wreak. Some food companies might find these rules inconvenient, but they are desperately needed to safeguard the public.”

Congress enacted the Public Health Security and Bioterrorism Prevention and Response Act in 2002. FDA Commissioner Mark McClellan recently told The New York Times that he was surprised that the FDA had not previously had clear authority before to guard against food-related bioterrorism.

[admin]

Docket Management
Docket: 02N-0278 - Bioterrorism Preparedness; Prior Notice of Imported Food Shipments, Section 307
Comment Number: EC -187
Accepted - Volume 14

Comment Record
Commentor Dr. Andrew Ebert Date/Time 2003-04-04 10:07:41
Organization International Food Additives Council
Category Association

Comments for FDA General
Questions
1. General Comments April 4, 2003 Hearing Clerk Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, Maryland 20852 Re: Prior Notice of Imported Food Under the Public Health And Bioterrorism Preparedness and Response Act of 2002 (Docket No. 02N-0278) IFAC, the International Food Additives Council, is the trade association representing producers of high purity materials intended for direct use in food by imparting a number of desirable food technological characteristics. IFAC is international in scope as there is extensive international trade in food additives and many food additives come from sources outside of the United States. Our members are therefore affected by the proposed regulations and file the comments listed below. IFAC’s initial observation is that the proposed regulations for the notice of product importation call for far more information than needed and request data that appear to have little value in protecting the food supply from terrorist activities. Much of the proposed activity is redundant with existing regulations and in several instances, compliance is difficult, if not impossible to achieve. IFAC recognizes that the proposal applies to all “food” products defined to include food ingredients and additives. IFAC points out that trade in food additives has certain unique characteristics that need be taken into account. For example, materials used as food additives often are marketed, hence transported, in small amounts. They often are not transported as a food or with a food. Common carriers are routinely used where the food additive represents only a minor portion of the cargo -- which would not be defined as a food. At times it is desirable to ship food additives under seal, in bond. Food additives are often added to foods, which undergo further processing before sale to the consumer. IFAC specifically comments: A. The proposal requires the grower of the article of food be identified, if known at the time of submission of the prior notice. In many cases, the sources of naturally occurring food additives, such as gums, spices, flavorings, etc., are not known or are consolidated from numerous sources. Also, virtually all food additives are subjected to further processing. Therefore, the final rule should not require the identification of growers of food additives. Page 2 B. The prior notice proposal refers to articles being “offered for import.” In the case of food additives, exemptions should include: Products traveling under bond Products to be immediately exported C. As food additive products are often pre-packaged, i.e. not shipped in bulk, they can, and often do, enter international transshipment under seal or in bond. Provision should be made for expedited handling of such product, including waving or modifying the prior notice timing requirements on notices of importation. D. Because there is considerable international trade of food additives, IFAC member companies have experience in food additive importation in compliance with various US Custom requirements. Customs transmits information to FDA’s OASIS (Operational Administration System for Import Support) by way of the Automated Brokers Interface of the ACS (Automated Commercial System). IFAC submits that the information therein provided should serve as a model to satisfy the import notice provisions of the Act. Unnecessary repetition of information now provided to US Customs should be eliminated. A review of the FDA requirements applicable to food additives, comparing FDA’s proposal with Customs requirements, is recommended. IFAC observes that FDA has listed in detail the requirements by which the importing firm is to inform FDA of the imminent arrival of imports. FDA then states it will inform importers when product has been accepted for import. What is lacking is a requirement for the Agency to inform the importer of actions taken when product is deemed not acceptable. Priorities and procedures need be established to separate products judged to be a risk to public health vs. material not accepted because necessary information has not been received or other administrative requirement satisfied. IFAC appreciates having the opportunity to comment on these important proposed actions. Sincerely, Andrew G. Ebert Andrew G. Ebert, Ph.D. President AGE/jcr






EC -187