FDA Proposes Two New Food Regulations for Imports

 The U.S. Food and Drug Administration proposed two new rules last week that would impact imported food, including by establishing a program to accredit third-party auditors to certify foreign food facilities.  The rules were called for by the Food Safety Modernization Act of 2011, which revised the regulatory system to deal with risks of food-borne illness. We have posted before about the litigation that can arise from such situations. 

 

Under the proposed rules, which follow on regulations proposed earlier this year, importers would be accountable for verifying that their foreign suppliers are implementing modern, prevention-oriented food safety practices, and achieving the same level of food safety as domestic growers and processors. The FDA is also proposing rules to strengthen the quality, objectivity, and transparency of foreign food safety audits on which many food companies and importers currently rely to help manage the safety of their global food supply chains.

Imported food comes into the United States from about 150 different countries and accounts for about 15 percent of the U.S. food supply, including about 50 percent of the fresh fruits and 20 percent of the fresh vegetables consumed by Americans.

Under the proposed regulations for Foreign Supplier Verification Programs (FSVP), U.S. importers would have a clearly defined responsibility to verify that their suppliers produce food to meet U.S. food safety requirements. In general, importers would be required to have a plan for imported food, including identifying hazards associated with each food that are reasonably likely to occur. Importers would be required to conduct activities that provide adequate assurances that these identified hazards are being adequately controlled.

The FSMA also directs the FDA to establish a program for the Accreditation of Third-Party Auditors for imported food. Under this proposed rule, the FDA would recognize accreditation bodies based on certain criteria such as competency and impartiality. The accreditation bodies, which could be foreign government agencies or private companies, would in turn accredit third-party auditors to audit and issue certifications for foreign food facilities and food, under certain circumstances.
Importers will not generally be required to obtain certifications, but certifications may be used by the FDA to determine whether to admit certain imported food that poses a safety risk into the United States.

The FSVP proposed rule and the third-party accreditation proposed rule are available for public comment for the next 120 days. 

 

FDA Issues Proposed Food Safety Rules

The FDA last week issued two highly anticipated proposed rules relating to food process safety, with a stated goal of preventing foodborne illnesses. Readers will recall our posts on the litigation that can arise from food safety issues. FDA has now released for public comment a proposed rule on Preventive Controls for Human Food and a proposed rule on Standards for Produce Safety.

These rules are two of the proposed rules that FDA says are key to the preventive food safety approach established by the 2011 FDA Food Safety Modernization Act. The proposed rules build on existing voluntary industry guidelines for food safety, which many producers, growers and others currently follow. FDA expects to soon issue its proposed rule on importer foreign supplier verification; future proposed rules will address preventive controls for animal food, and accreditation of third-party auditors.

The FDA will accept comments on the proposals for 120 days. While the effective date for the rules would be 60 days from publication of the final rule, the general compliance date would be two years after the effective date. For small businesses, the compliance date would be three years after the effective date, and for very small businesses four years after the effective date.

The proposed rule on preventive controls for human food would apply to facilities that manufacture, process, pack or hold human food. In general, with some exceptions, the new preventive control provisions would apply to facilities that are required to register with FDA under FDA’s current food facility registration regulations. The rule proposes firms have written plans in place to identify potential hazards, put in place steps to address them, verify that the steps are working, and outline how to correct any problems that arise. FDA says the proposed hazard analysis rules are similar to the "HACCP” (Hazard Analysis and Critical Control Points) regulations that govern the production of certain seafoods and meats. The proposed produce rule covers all fruits and vegetables except those rarely consumed raw, produced for personal consumption, or destined for commercial processing that will reduce microorganisms of public health concern.

FDA estimates that the total annual compliance costs for the two regulations will exceed $1 billion.  million, depending on the scope of the exemption for “very small businesses.” The draft appears not to offer an estimate of the benefits that might result from the new rules.

FDA Holds Meeting on Food Safety Modernization Act Regulations

We have posted before about the Food Safety Modernization Act.  The FDA held a public hearing last week to take input on the implementation of the new food safety law.

FDA was seeking information on preventive controls used by facilities to identify and address hazards associated with specific types of food and specific processes.

After an intro from several FDA officials, the program included several breakout listening sessions. One covered FDA guidance documents for industry on preventive controls. FDA has recognized that it cannot provide a guidance document for each type of food or each type of food facility. Another breakout session focused on the relationship between CGMPs and the preventive controls. A third was on Product Testing and Environmental Monitoring. 

The session concluded with comments from stakeholders, including representatives of consumer groups, the food and feed industries, state regulatory officials, and small business groups.  Among those weighing in were the American Frozen Food Institute and the American Feed Industry Association.  One of the key requests from industry was the need for flexibility and the risks of too-rigid guidance to prevent contamination.  One size does not fit all, and each industry may be in the best position to figure out the specific tools they need.  Indeed, different facilities within an industry may need to employ different systems to prevent food safety hazards. Industry also called for FDA to recognize robust third-party food safety certification programs that are already in place in some food areas. 

Self-appointed consumer groups, on the other hand, called for extensive and detailed regulations of testing, with test protocols to be submitted to FDA in advance and approved.  

Food Safety Bill Passes Senate

An update on the food safety legislation, which we posted about last week.

The Senate passed the Food Safety Modernization Act by a vote of 73-25. The chamber rejected a series of final amendments. One of them would have replaced the entire bill with a more modest version authored by Sen. Tom Coburn, R-Okla.; it failed by a 62-36 vote. 

Despite bipartisan support for an overhaul of FDA’s authority to regulate food, the bill faces an uncertain future since it appears there is insufficient time for a conference to reconcile the House and Senate versions.The Senate legislation differs from the House version in several respects, including the fees the FDA can charge, regulation of small food businesses and farms, and frequency of required inspections. It may be that the House will vote to pass the Senate version.  There is also some concern that the Senate invaded the tax authority that belongs to the House when it included revenue-raising fees in the Senate bill.

The expanded inspections and recall authority may lead to additional litigation down the road involving the food industry.

Food Safety Bill Advances in Senate

The U.S. Senate last week voted to move forward to the final debate on legislation aimed at amending regulatory controls on both domestic and foreign food supplies.  The Senate voted 74-25 to invoke cloture on S. 510, the Food Safety Modernization Act.  The bill is sponsored by Senate Majority Whip Dick Durbin, D-Ill., and a bipartisan group of 20 other Senators.

The procedural vote was designed to open the final round of the Senate's food safety debate, although it is unclear wither the Senate Democratic leaders will allow additional amendments to the bill on the Senate floor.  Some Senate Republicans have urged that they be allowed unlimited amendments during floor debate leading up to the vote on final passage.  While some amendments may be designed to strengthen the FDA inspection process of both domestic and foreign food production facilities, one highly controversial step would be if Sen. Dianne Feinstein, D-Calif. again offers an amendment to the bill that would impose a federal ban on the
use of bisphenol A in children's food packaging. 

That position does not hold substantial support in the Senate, and her shrill insistence on the ban delayed Senate action on a much larger and more comprehensive legislative package.  Indeed, a member of her own party, Rep. John Dingell (D-Mich.), criticized her in a public letter for holding up this bill.  Other key remaining issues include treatment of small farmers, and the role, if any, of local and state food inspections.

The bill would give the FDA new authority to track and halt contaminated food coming from domestic and foreign suppliers. Food facilities would be required to provide additional information to the FDA, submit to more frequent inspections and to develop their own tracking systems. The agency would also get new mandatory recall authority over tainted food, and additional authority to deal with misbranded or adulterated products.

The House passed a companion bill, H.R. 2749, the Food Safety Enhancement Act, by a vote of 283-142, in July 2009.  The typical conference committee to iron out differences may be an issue given the lateness in the lame-duck session in Congress. It is possible the House could vote to accept the Senate version, if it indeed passes.

There are about 76 million cases of food-borne illnesses every year in the U.S., leading to 325,000 hospitalizations and 5,000 deaths, according to the CDC.

 

Senate Moves Forward With Compromise Food Safety Act

U.S. Senate negotiators apparently reached an agreement last week on food safety legislation in order to have it ready for the full Senate to consider when lawmakers return from the summer recess.

The group that negotiated the framework for the new Senate version of the Food Safety Modernization Act included Tom Harkin, D-Iowa; Mike Enzi, R-Wyo.; the bill's authors Dick Durbin, D-Ill., and Judd Gregg, R-N.H.; and lead co-sponsors Christopher Dodd, D-Conn., and Richard Burr, R-N.C.

The bill would require facilities that manufacture, process, pack, or hold food to have in place risk-based preventive control plans to address identified hazards and prevent adulteration.  It requires importers to verify the safety of foreign suppliers and imported food. It would give the FDA additional resources to hire new inspectors and requires FDA to inspect food facilities more frequently. The bill gives the FDA authority to order a mandatory recall of a food product if the food will cause serious adverse health consequences or death and a company has failed to voluntarily recall the product upon FDA’s request. It has provisions to enhance surveillance systems to detect food-borne illnesses.

Significantly, this version does not include language banning BPA, as originally demanded by Sen. Feinstein.  Her prior insistence, despite a lack of scientific evidence supporting such a ban, was one of the major logjams for the bill. She says she still plans to introduce an amendment to ban BPA from children’s products as soon as the bill arrives on the Senate floor.  Clearly, an abrupt and unnecessary ban on packaging containing BPA would affect consumer ability to find nutritious, valuable, and shelf-stable foods and beverages. The proposed ban runs counter to the fact that BPA has been used for over 30 years to improve the safety and quality of food and beverages, including by providing protective coating for cans. The overwhelming scientific evidence points to the conclusion that at current human exposure levels, BPA is not toxic. What is in fact occurring is that anti-chemical activists are simply manipulating consumers’ fears, and opportunistic politicians are jumping in.