Food Safety Legislation and the BT Act Connection

•The U.S. Food and Drug Administration (FDA) issued four proposed rules under the Public Health

Security and Bioterrorism Preparedness and Response Act of 2002

October 14, 2003Changes affecting WBFI Membership Registration

 • Clear Exemption for Transporter Vehicles (Truckers, Rail, etc). • FDA believes that it is reasonable to include food consumed by animals in

the definition of “food” and thus, require the registration of facilities that manufacture /process, pack, or hold food for consumption by animals.

• FDA agrees with WBFI comment that the Retail Food Establishments should include animal food retailers as exempt from registration. A retail establishment may manufacture/process, pack, or hold food if the establishments’ primary function is to sell from that establishment food that it manufactures/ processes, packs, or holds directly to consumers.

• Manufactures of packaging (bags, boxes, etc.) are exempt. FDA has determined that it is permissible, for purposes of the registration provision, to exclude food contact materials from the definition of “food”

•  This, the plain language of the BT Act requires registration to be by individual facility, not by firm. FDA will allow a parent company to register all of its facilities; however, each facility must be registered separately and each will receive a separate registration number.

Bioterrorism Act Training WBFI-KC Nov. 1, 2003

• Section 305:Registration• Creating An Account for Online FDA Industry

System•Register A Food Facility•FDA’s Prior Notice

Bioterrorism Act Training WBFI FL, Nov. 2005

• Section 306: Establishment and Maintenance of Records • Final rule was published Dec. 9. 2004• No Exemptions for WBFI Membership• Compliance dates (6, 12, 18 months for large, small and very

small businesses, respectively)• Food: Definition in section 201 (f) of the Federal Food, Drug

and Cosmetic Act applies: -i.e., “(1) articles used for food or drink for man or other

animals, (2) chewing gum, and (3) articles used for components of any such article”

What Foods Does FDA Not Regulate?

• Foods to the extent they are under the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) under the:- Federal Meat Inspection Act (21U.S.C. 601)

- Poultry Products Inspection Act (21U.S.C. 451)- Egg Products Inspection Act (21U.S.C. 1031)

Records Established and Maintained to Identify the IMMEDIATE PREVIOUS SOURCES (IPS)

• Firm name; address; telephone number; fax number, and e-mail address, if available of the non-transporters IPS (domestic and foreign)

Description of type of food received, including brand name and specific variety. For imported product the bags marks must be recorded.

Date food was received For persons who manufacture, process or pack food, the lot or code

number or other identifier (to the extent the information exists) Quantity and how the food is packaged (e.g. 25 lb. cartons) Firm name; address; telephone number; fax number; and e-mail

address, if available, of the transporter (IPS) who brought the food to you.

Records Established and Maintained to Identify the IMMEDIATE SUBSEQUESNT RECIPIENT (ISR)

• Firm name and contact information of the non-transporters ISR (domestic

and foreign)• Description of type of food released, including brand name and specific

variety• Date food was released• For persons who manufacture, process or pack food, the lot or code

number or other identifier (to the extent the information exists)• Quantity and how the food is packaged (e.g. 25 lb. cartons)• Firm name and contact information of the transporter ISR who transported

the food from you.• Note: Blind shipments or CPU (customer pick up) is not allowed.• Records must include all information reasonably available to you to

identify the specific source of each ingredient that was used to make every lot of finished product (note: what is reasonably available may vary from case to case)

Partial Exclusion• Persons who distribute food directly to consumer – excluded

from requirement to establish and maintain records to identify the immediate subsequent recipients as to those transactions

• Consumers do not include businesses. Business sales require record keeping not consumer sales

• NOT EXCLUDED: Records of the Immediate Previous Source

• Retailers are responsible to have IPS records

What are the record availability requirements?

• When the FDA has a reasonable belief that an article of food is adulterated and presents a threat of Serious Adverse Health Consequences Or Death To Human Or Animals, any records or other information to which FDA has access must be available for inspection and photocopying or other means of reproduction as soon as possible, not to exceed 24 hours from the time of receipt of the official request.

• FDA will issue a 482 Notice of Inspection

What will happen if the required records are not established and maintained?

• The Bioterrorism Act makes failure to establish and maintain records or failure to make them available to FDA a prohibited act. The Federal government can bring a civil action in Federal court to enjoin persons who commit a prohibited act; the Federal government also can bring a criminal action in Federal court to prosecute persons who commit a prohibited act.

What records are excluded from BT Act records access?

• Recipes for food (as defined in the rule)• Financial data• Pricing data• Research data• Sales data (other than shipment data regarding

sales)

FDAAA – Food & Drug Administration Amendments ActDocket No. FDA-2007-N-0442

  Signed into law by President Bush September 27, 2007 (Public Law 110-85) FDAAA Section 1002(a) directs that within 2 years, FDA must Publish pet food ingredient standards and definitions, processing standards, and updated standards for pet food labeling that include nutritional and

ingredients information. FDA will collect comments and establish Standards & Definitions by September 2009. FDA believes Ingredient Standards & Definition will make feed safer and are considering user fees from

countries that don’t have animal feed regulations. FDA sponsored a public meeting May 2008 as part of its Animal Feed Safety System (AFSS) and presented

the third draft of AFSS Framework and work-in-progress on a method for ranking animal feed hazards by their risks to animal and human health.

Ranking scheme consists of two components, health consequence scoring and exposure scoring and described methods for ranking risks associated with biological and chemical hazards in feed. FDA is interested in obtaining input from interested industry and the public as to whether the ingredient standards and definitions and processing standards should be developed for all animal feeds. The agency believes the most appropriate course of action is to develop ingredients standards and definitions and

processing standard for all animal feed, including pet food. Questions asked include: Should ingredient definitions also be developed for other animal feeds in addition to

pet food? Should such standards be developed and applied to all animal feeds rather than be limited to pet food?

First comments submitted by June 13, 2008 AAFCO submitted comments.

MOU number: 225-07-7001Memorandum of Understanding Between U.S. FDA and AAFCO

PERIOD Of AGREEMENT from 8-21-07 until 9-1-2012

BACKGROUND The Association of American Feed Control Officials (AAFCO) is a voluntary membership organization of US states and Federal government agencies, as well as government agencies from other countries, responsible for the execution of laws and regulations pertaining to the production, labeling, distribution, use and/or sale of animal feed and feed ingredients.

AAFCO membership consists of all fifty states, Puerto Rico, Costa Rica, Canada, FDA, USDA and several universities. It is governed by Officers and a Board of Directors elected by the membership at the annual meeting of AAFCO. FDA is a member of AAFCO and serves in an advisory role on the AAFCO Board.

PURPOSE Some articles added to animal feed fall under the preview of other Federal agencies. The EPA regulates feed-through pesticides, and vaccines added to animal feed are the responsibility of the USDA. The purpose of this memorandum is to facilitate FDA’s collaboration with AAFCO in the AAFCO New and Modified Feed Ingredient Definition Process by clarifying the responsibilities of FDA and AAFCO during the feed ingredient definition and providing mechanisms for resolving disputes that arise and for modifying the process when required.

  The FDA and AFFCO agreed to 10 conditions. AAFCO President Rick Schroeder and Stephen F. Sundlof, Director, FDA/CVM signed the MOU on August 21, 2007.

U.S. Producer and Agribusiness Group Food/Feed Safety Legislative Principles

January 5, 20081. Require FDA Regulation and Inspections to be Science-

and Risk- Based2. Authorize FDA to Recognize or Accredit Third Parties 3. Link Expedited Port Entry to Import Risk and Adoption

of Safety Programs for High-Risk Products4. Authorize Certification of ‘High-Risk’ Imports5. Establish Science- and Risk-Based Inspection

Approaches for Imported, Domestic Products6. Expand Research and Diagnostic Laboratory Capacity7. Modernize and Harmonize Intra- and Inter-Agency

Computer Systems8. Expand Education and Training of Inspectors

Significant Impact on Members from Food Safety Enhancement Act June

2009• The Food Safety Enhancement Act of 2009 (H.R. 2749),

which contains provisions with far-reaching consequences for the food industry is on a fast track in the U.S. House of Representatives. Because of a host of problematic provisions in the bill, such as the traceability and country of origin sections and increased fees on the food industry.

• Traceability. The bill would continue to require FDA to establish a tracing system for all food, but it no longer prescribes the specific elements of the tracing system. The tracing system established would enable FDA to identify within two business days, each person who grows, produces, manufactures, processes, packs, transports, holds, or sells food.

Far Reaching Food Safety Bill Passed by the U.S. House of Representatives July 2009

• The first restructuring of food safety law in 70 years was passed by the U.S. House of Representatives on a vote of 283-142 on July 30, 2009. The Senate may vote on the bill in the fall, but at this point the future is unknown. If signed into law, The Food Safety Enhancement Act of 2009, H.R. 2749, will have a significant direct impact on the food industry, including the following provisions:

• Allow the FDA to order product recalls. Currently the FDA can only request companies to recall their products.

• Authorize the FDA to set science-based standards for food manufacture and handling, and then require manufacturers/food facilities to demonstrate compliance or face strong penalties.

• Mandate more frequent FDA inspections—once a year for high—risk facilities and once every three years for others. Currently manufacturing sites are only inspected about once a decade.

• Require food facilities and importers to pay a $500 per facility annual fee. • Establish a food tracing system through the FDA.

Senate Committee to Vote on Food Safety Bill

November 2009

• Months after the House approved food safety legislation; action is finally beginning in the Senate, although the timing of any final action remains uncertain.

• On November 18, 2009, the Senate Committee on Health, Education, Labor and Pensions is scheduled to debate and vote on a food safety bill.

• Require all facilities to have preventative plans in place to address identified hazards and prevent adulteration, and give FDA access to these plans and relevant documentation.

• Expand FDA access to records in a food emergency. • Require importers to verify the safety of foreign suppliers and imported

food. The FDA is allowed to require certification for high-risk foods and deny entry to a food that lacks certification or that is from a foreign facility that has refused U.S. inspectors.

• Increase FDA inspections at all food facilities. • Authorize the FDA to order a mandatory recall of a food product when a

company fails to voluntarily recall the product upon FDA request.

FDA RFR and HACCP PresentationWBFI FL 2009

• Event Planning Committee provided handout to the membership on both Hazard Analysis Critical Control Point (HACCP) and the FDA (RFR)Reportable Food Registry

• FDA Reportable Food Registryeffective September 8, 2009

Sept. 2010 Legislative/Regulatory Meeting

Washington, DC• The FDA explained the increased inspections at U.S. ports, along with detailed information

about the FDA’s risk profile on pathogens in spices, port reforms and food safety legislation. The day was filled with speakers providing information ranging from the FDA’s Reportable Food Registry to pesticide residues.

• Although Nyjer seed is controlled by the USDA the FDA has now taken a more active role by detaining shipments for sampling.

• FDA’s Acting Deputy Director, Office of Food Defense, Communication and Emergency Response, Kathy Gombas, provided attendees with unpublished numbers on the first year of the Reportable Food Registry (RFR). She gave an update on enhancements to the system and encouraged companies to register in advance of filing any reports because only registered users can take advantage of new features designed to make the system more user-friendly. For example, registered users can now save their reports and will not get timed out after 30 minutes.

• FDA Domenic Veneziano, Director, Division of Import Operations and Policy provided a presentation about a strategic plan being implemented to update their outdated IT infrastructure and lack of predictable time frames regarding detained products.

Legislative/Regulatory MeetingWashington, DC continued

• FDA Risk Profile; risk objectives - pathogens & filth• Describe and evaluate current mitigation and control options• Identify levels of pathogens; levels from farm to table • Imported versus Domestic • FDA began hiring and training over the past couple of years

that now they employ 8 to 1• 8 in the field to 1 compliance officer

– How well do you know your supplier?– Do you test your product? If so when?– Is their a decision to treat? If so when is that made?

Sept. 2010 Washington, DC Food Safety Enhancement Act

• Bill McConagha, Counsel for the Senate Health, Education, Labor and Pension Committee and Travis Jordon, Legislative Assistant for Senator Mike Enzi (WY) explained to attendees that food safety legislation would not be voted on before Congress adjourned for the elections, but that there was a small possibility a vote would be held during the lame duck session after the elections.

• They described the foreign supplier verification program, which requires importers to do “due diligence” in ensuring their product is safe.

• Requirements such as onsite visits, sampling and testing will most likely be mandatory. Much of the specifics in this provision and others in the bill will be left up to the FDA because after Congress passes a bill the federal agency with jurisdiction writes the regulations, which provide the details regarding how the bill should be implemented. The import certification required for high risk food was another provision that was discussed. The FDA would most likely rely on third party auditors to provide certifications.

Sept. 2010 Washington, DC Food Safety Enhancement Act

continued• Food Safety Bill as written now S510 section 310 –

responsibility of importer or owner that brought the product into the US

• Inspection Frequency based on risk level– High Risk domestic facilities, once in the first 5 year after enactment

and every 3 years thereafter.– Non-high Risk domestic facilities, once in the first 7 years after enactment and every 5 years thereafter• In addition, in the first years after enactment, FDA would be require to

inspect 600 foreign facilities; thereafter’ the agency would be required to double the number of inspections of foreign facilities every year for five years.

Sept. 2010 Washington, DC Food Safety Enhancement Act

continued• Product Recalls: In order to improve recall communications, the revised bill

would require FDA to establish an incident command operation that would operate within 24 hours of the initiation of a class 1 recall, regardless if the recall was mandated or voluntary. Additionally, FDA would be required to provide an annual report to Congress identifying when the agency used the mandatory recall authority and the circumstances by which the agency concluded that the situation warranted use of such authority

• Reportable Food Registry: The revised bill would allow FDA to require a responsible party to submit consumer-oriented information to the RFR to enable the consumer to identify whether the consumer possesses the reportable food. In addition, individual stores would be required to post this information in a standardized format prepared by FDA. The criteria triggering an RFR report remain unchanged by the bill.