2005 Food Code Updates Food Safety Guidelines

The U.S. Food and Drug Administration (FDA) issued the 2005 edition of the Food Code, which contains the latest science-based information on food safety for retail and food service industries. The Food Code is used as a reference by nearly 3,000 regulatory agencies that oversee food safety in restaurants, grocery stores, nursing homes, and other institutional and retail settings.

"This year's Food Code not only includes the best practices for the retail and food service industries but it also provides valuable resources on food defense that will assist in protecting Americans against threats to the food supply," said FDA's Center for Food Safety and Applied Nutrition Director Robert Brackett.

In collaboration with the Conference for Food Protection, the Centers for Disease Control and Prevention (CDC), and U.S. Department of Agriculture (USDA), the updated Food Code focuses on enhancing food safety practices based on new scientific and programmatic information. The most significant changes include:

• A definition for major food allergen that is consistent with the Food Allergen Labeling and Consumer Protection Act of 2004. The person in charge of a food establishment must demonstrate knowledge about the major food allergens [i.e., milk, egg, fish, crustacean shellfish, tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans].
• An amended definition of potentially hazardous food [also known as time/temperature control for safety (TCS) food] to reflect those that could allow pathogenic microorganism growth or toxin formation;
• Added new controls and operations for reduced oxygen packaging; summarized available resources on food defense and links to useful publications from the FDA, CDC, USDA, and industry groups;
• Refocused date-marking provisions on foods that present a higher risk of contamination. Date marking is the practice of indicating the date or day by which a ready-to-eat, potentially hazardous food should be consumed, sold, or discarded; and
• Updated Employee Health provisions to include better ways to protect public health, based on new science on pathogens that are most likely to be transmitted from an infected food worker through food to consumers.

Local, state, tribal, and federal regulators voluntarily use the Food Code as a model to develop or update their own food safety rules and to maintain consistency and uniformity with national food regulatory policy. The Association of Food and Drug Officials reported in June 2005, that 48 of 56 States and territories have adopted food codes patterned after the Food Code. Those 48 states and territories represent 79 percent of the U.S. population.

The 2005 Food Code is available online. In approximately 8 weeks, copies of the Food Code can be purchased from the National Technical Information Service, U.S. Department of Commerce; Springfield, VA 22161.

Questions and Answers (Q's & A's) on the 2005 Food Code are available online. A summary of changes that appear in the 2005 Food Code is also available online.

FDA Proposes Additional "Mad Cow" Safeguards

FDA has just announced new measures to help further protect consumers against the agent thought to cause bovine spongiform encephalopathy (BSE), also known as "mad cow disease." The Agency is proposing to amend its animal feed regulations to prohibit from use in the food or feed of all animals certain high risk cattle materials that can potentially carry the BSE-infectious agent. All of the proposed prohibitions, except for those related to tallow, have already applied to cattle feed since 1997.

Those high risk cattle materials prohibited in the new proposed rule include:

• the brains and spinal cords from cattle 30 months of age and older,
• the brains and spinal cords from cattle of any age not inspected and passed for human consumption,
• the entire carcass of cattle not inspected and passed for human consumption if the brains and spinal cords have not been removed,
• tallow that is derived from the materials prohibited by this proposed rule if the tallow contains more than 0.15 percent insoluble impurities,
• mechanically separated beef that is derived from the materials prohibited by this proposed rule.

This proposed regulation builds on a series of firewalls that include FDA's 1997 feed regulation which prohibits the use of certain mammalian-origin proteins in ruminant feed (e.g. for cattle and sheep), but allows these materials to be used in feed for non-ruminant species. The removal of high-risk materials from all animal feed-including pet food-will protect against the transmission of the agent of BSE that could occur either through cross-contamination of ruminant feed with non-ruminant feed or feed ingredients during feed manufacture and transport, or intentional or unintentional misfeeding of non-ruminant feed to ruminants on the farm.

In July 2004, FDA and USDA jointly published an Advance Notice of Proposed Rulemaking (ANPRM) in which FDA announced its tentative conclusion that it should propose banning specified risk materials (SRMs) in all animal feed. In this ANPRM, FDA asked for comment on this measure and also on other feed control measures such as prohibiting the use of all mammalian and poultry protein in ruminant feed.

FDA also asked for comment on the set of measures that the agency had announced in January 2004 including the elimination of the exemptions for blood and blood products and "plate waste" from the 1997 ruminant feed rule, a prohibition on the use of poultry litter in ruminant feed, and a requirement for dedicated equipment and facilities to prevent cross-contamination.

FDA has carefully analyzed the comments it received on the 2004 ANPRM and has concluded that the other feed control measures discussed in the ANPRM are not needed if the high-risk tissues identified in this proposed rule are excluded from all animal feed channels.

Comprehensive information about FDA's work on BSE and links to other related websites are available online.

FDA Updates Listing of Harmonized Tariff Schedule (HTS) Codes Flagged with Prior Notice Indicators

In October 2003, FDA published an interim final rule in the Federal Register requiring submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States (68 FR 58974). FDA also issued a guidance pertaining to the Harmonized Tariff Schedule (HTS) codes to help the food industry comply with the legal requirements established by the prior notice interim final rule. The HTS codes apply to prior notice submitted via the U.S. Customs and Border Protection's (CBP's) Automated Broker Interface of the Automated Commercial System (ABI/ACS) and via FDA's Prior Notice System Interface (PNSI). The HTS codes table found in the guidance document is periodically updated to reflect changes in the HTS codes or in FDA indicators for those codes.

The listing of HTS Codes Flagged with Prior Notice Indicators and the Revision History List on the website were updated in September 2005. The listing of HTS Codes Flagged with Prior Notice Indicators is available online at FDA's website. Users of this list should ensure they are using the most current version of this table. The date of issuance of this table is indicated at the top of the title page of the table. CBP will notify users of the ABI/ACS when changes in this table are made in ABI/ACS.

Office of Food Safety, Defense, and Outreach

CFSAN Web site: http://www.cfsan.fda.gov/