A legislative hearing will be held tomorrow (June 3) regarding the discussion draft of a bill by Henry Waxman. It’s expected the Waxman bill will be the lead food safety bill in the House, while a bill introduced by Richard Durbin will continue to be the lead bill in the Senate.

AFI’s Legislative Task Force members received a detailed comparison of the two bills and will help develop AFI’s position and any needed comments. As always, all members are welcome to provide input.

Some measures called for in both bills:

• Food facilities would have to re-register with FDA on a regular basis.
• Food facilities would have to develop and implement written preventive control plans.
• All food facilities would have to be inspected by FDA at least once every four years.
• Industry fees, including registration fees.
• Mandatory recall authority for FDA. FDA also would have the authority to detain food based only on a “reason to believe” the food is adulterated or misbranded.
• Inspections of foreign facilities.

Differences in the bills include:

• Waxman’s bill would require annual registration; Durbin’s biennially.
• Waxman’s bill would require complete traceability systems for all entities within a product’s movement from farm to table.
• Waxman’s bill would require importers, customs brokers and filers to register with FDA and pay an annual registration fee. Durbin’s bill calls for a voluntary qualified importer program which would be funded by fees paid by participants.
• Waxman’s bill would authorize FDA to assess civil fines for each prohibited act. Durbin’s bill adds fines only for failure to comply with a recall order.
• Waxman’s bill would require the labels of processed foods to indicate the country where the final processing occurred and require the manufacturer’s website to list the country of origin of each ingredient in the food.

As mentioned, the Waxman bill is a discussion draft, meaning it has not been introduced yet. It’s expected to be introduced and reviewed by the House Energy and Commerce Committee on Health shortly. A 32-page file prepared by Olsson Frank Weeda Terman Bode Matz that outlines the provisions in both bills is available in the “members only” portion of the AFI website.

FDA revised a compliance policy guide that provides written guidance to FDA and U.S. Customs and Border Protection staff on enforcement of the requirement for prior notice of food imported or offered for import into the U.S. under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). This document can be found on the FDA’s Web site under “Compliance References.”

The compliance policy guide represents the FDA’s current thinking on its enforcement policy concerning prior notice but does not create or confer any rights for or on any person.

FDA is requesting a budget of $3.2 billion as part of the president’s fiscal year (FY) 2010 budget – a 19 percent increase over the current FDA budget. The FY 2010 request, which covers the period of Oct. 1, 2009, through Sept. 30, 2010, includes increases of $295.2 million in budget authority and $215.4 million in industry user fees.

The FDA budget proposes two major initiatives for FY 2010: Protecting America’s Food Supply and Safer Medical Products. It also includes increases for current law user fees and for infrastructure to support critical agency operations. FDA is also proposing four new user fees to facilitate review of generic drugs, register and inspect food manufacturing and processing facilities, reinspect facilities that fail to meet Good Manufacturing Practices and other safety requirements, and issue export certifications for food and feed.

The Protecting America’s Food Supply initiative focuses on foreign and domestic sources of ingredients, components and finished products at all points in the supply chain, including their eventual use by the American public. Within this initiative, FDA proposes to collect $94.4 million in new user fees to register food facilities and increase food inspections, issue food and feed export certifications and reinspect food facilities that fail to meet FDA’s safety standards.

Customs and Border Protection should delay implementation of the Importer Security Filing rule until the World Customs Organization has had time to review its compatibility with the SAFE Framework security standards, the European Commission said.

In comments on the ISF (10+12) rule, the EC said data elements that are not included in the SAFE Framework would not be accepted by trading partners because they would be unreliable with no way to verify their accuracy.

Customs will begin enforcement of the ISF rule in January 2010. The EC said a “more effective global approach” is possible if Customs waits for the WCO to complete its review.

June 26, 2009 – North American Olive Oil Association Meeting in New York

November 13, 2009 – AFI Town Meeting, French Culinary Institute, New York.