August 4, 2008

AFDO Position Statement Regarding: New Federal Food Safety Legislation

The Association of Food & Drug Officials (AFDO) supports the concept of a fully integrated food safety system, which utilizes the resources, expertise, and authority of state, local, and federal government. Federal food safety legislation that fails to recognize the efforts and impact of state and local food safety regulatory agencies is destined to fail as the overwhelming majority of food safety efforts are conducted at the local and state levels. Food safety is not a federal responsibility alone but a shared responsibility of government at all levels, industry, and consumers. It is AFDO’s position that any federal food safety legislation must be consistent with the points outlined below:

1.        Make It Easier To Share Public Health Information

Federal food safety agencies must be authorized to share food product distribution information with State and Local government during the course of outbreak investigations, recalls and other food emergencies. Quick response action prevents foodborne illness and saves lives. State and Local agencies are in the best position to respond quickly or to conduct recall effectiveness audits and ensure that contaminated food products are removed from commerce.  State Health agencies need distribution information to conduct thorough foodborne illness outbreak investigations and link similarly exposed cases of illness.  Currently, distribution information is held as proprietary information and the federal agencies are unable to share this information unless State representatives sign non-disclosure agreements or memorandum of understanding agreements that can not be adhered to or may place States in violation of the federal Freedom of Information Act. Effective response to emergency situations such as Class 1 recalls, which involve contaminated foods cannot be accomplished until this matter is resolved.

NOTE - North Carolina recently employed an Incident Command System (ICS) utilizing state and local government officials from a multitude of agencies within that state to address a widely marketed chili sauce recall. They performed more recall audit checks in North Carolina than the rest of the country combined and removed from sale approximately 32,000 units of the tainted product from domestic channels in that state. They also found a large number of these botulism-tainted products in children’s camps and other non-traditional food venues ready for sale or service. Federal agencies need to review their response efforts with recalls and establish a formalized strategy with state and local government to significantly improve recall response as was done in North Carolina.

2.        Expand and Fund Cooperative Programs

FDA should have cooperative agreements with state and local food protection programs for the purpose of conducting strategic food safety inspections and surveillance. Currently, three unfunded cooperative programs exist where states perform independent regulatory control: interstate milk shipments, retail food and food service, and shellfish shipment. The Environmental Protection Agency (EPA) has cooperative agreements with state pesticide programs and utilizes the states activities and results for enforcement and planning purposes. Utilizing cooperative programs and nationally recognized standards will create national uniformity, reduce duplication of efforts, and allow us to address food safety challenges in a more coordinated fashion. States are better positioned, for example, to take on new roles in mandatory food safety regulation beginning at the farm level. Working with imported foods is another burgeoning area to leverage state resources.

NOTE - A number of states are leading the way in mandatory requirements for vegetable growers and packers. California and Florida have introduced mandatory programs for specific commodities in their states. FDA should model these programs through cooperative agreements so they become nationally accepted. New York and Texas have imported food initiatives with various federal agencies in these states and successfully monitor imported foods that enter into domestic commerce. These programs should be expanded to other states through cooperative agreements.

3.        Expand State and Federal Recall Authorities

Federal food safety agencies should have recall authority. Caution should be used, however, to ensure the food industry does not relinquish its ultimate responsibility to act. Federal authority to mandate a recall should come with protection to act at a lower threshold than lot-by-lot proof of adulteration.

NOTE - most states do not have recall authority, but they do have food seizure or embargo authority that can be used, as a sanction should a company refuse to recall their products. FDA does not have the ability to embargo or seize food and, therefore, should have recall authority. States should have the ability to enact legislation mirroring federal recall authority if needed.

4.        Accept State Inspection and Analytical Data

Federal agencies should be directed to establish protocols by which they can accept state inspection and food sampling analytical work and use it in enforcement activities including import alerts. Failure to accept food safety information developed by the states creates delays in addressing public health risks and increased costs. A 2001 survey of food safety program managers from all 50 States, conducted by AFDO found that, nationally, State Public Health and Agriculture labs analyze more than 300,000 food samples each year. Federal agencies must integrate state and federal inspection and analytical data to guide operational, enforcement, and policy decisions.  The U.S. Food & Drug Administration (FDA) does not currently accept State inspection and analytical data and must duplicate analysis before acting to protect consumer health and safety.

NOTE - In the last 5 years, the New York State Department of Agriculture and Markets has coordinated 1,400 recalls of imported food products from 61 countries based on laboratory analysis of the food products.  FDA re-analyzed only 13 of these food samples from the 1,400 and issued an import alert in all 13 instances.  FDA did not act on the remainder of these foods that NYS found to be in violation of State and Federal requirements.

5.        Align Responsibilities With Agreed Upon Roles

Ideally (conceptually at least), state and local governments should be the primary deliverers of domestic food safety regulatory services, so the federal government could devote more resources to imported foods. Additionally, the federal government should guide the collaborative development of food safety goals and policy and provide for national consistency through technical support, audit/oversight, and a significant level of funding.  This funding must be: adequate, ongoing, allocated based on risk, used flexibly by states to minimize food safety risk, and contingent on federally evaluated attainment of agreed upon food safety outcomes (e.g., program performance standards).

NOTE - This concept is not a new. A program funded by FDA from 1998 - 2002 called the “National Food Safety System” project (NFSS) was intended to integrate the food safety resources of government at all levels. The primary objective of NFSS was to improve food safety through a collaborative effort of federal, state and local government. The belief being a fully integrated seamless system, which was science-based, would build consumer confidence and address all of our food safety challenges.  It would be foolish to ignore some of the progress already in place, which resulted from the activities of the NFSS project.  The following are examples of significant NFSS accomplishments achieved since the inception of this project in 1998:

a)       eLEXNET – a secure electronic data sharing system for food safety laboratory data

b)       ISO Accreditation – an internationally recognized laboratory accreditation program aimed at assuring uniform methodologies for federal, state and local laboratories

c)       Directory of Laboratory Capabilities – a compilation that identifies federal, state and local laboratory capabilities in preparation for emergency needs

d)       AFDO Recall Workgroup – an effort involving state and federal (FDA and FSIS) officials to streamline and better coordinate recalls for increased effectiveness in removal of contaminated product from the marketplace

e)       Validation of Laboratory Methodologies – a joint federal/state effort to standardize and develop national rapid detection methods

f)        Foodborne Illness Outbreak Coordination Guidelines – developed to provide uniform investigational procedures and information-sharing protocols

g)       ORA-U – development of a comprehensive national training and certification system to better facilitate uniform food safety activities among all federal, state and local field inspectors

h)       Uniform Criteria Workgroup – development of uniform national regulatory program standards

i)         Integrated Food Safety Partnership – provides a pilot program that integrates the food safety functions of a state and the FDA.

j)         The goals of the NFSS project are to establish a system that would better utilize and leverage all the committed food safety resources (at all levels of government), build uniformity and consistency (with inspectional, analytical, enforcement and surveillance activities), increase the level of consumer confidence by improving food safety, and implementation of ONE food safety system.

6.        Leverage States for Inspecting Imported Food

A more integrated approach for addressing imported foods is needed. By allowing state agencies to handle more of the domestic food safety matters, FDA can devote more time to imported food concerns. However, FDA should expand current contracts with States to assist in import food surveillance. States are well positioned to utilize unique authorities to monitor and analyze imported foods in domestic and import status.

NOTE – Despite the added resources provided to FDA, less than 1% of imported foods entering into this country is physically examined. The imported food models that exist in New York and Texas should be used as a national strategy. In New York and Texas, state investigators are utilized for imported food inspections at border crossings, food warehouses, and ethnic food stores. State authorities are employed where necessary and information is shared among all government agencies associated with imports.

7.        Budget Line Item for State Funding

A line item in the federal budget must be established for funding state contracts, partnerships, and cooperative agreements. There is ample precedence for federal funding of state and local environmental protection efforts. FDA and USDA simply do not have the resources to protect the nation’s food supply without State and Local government assistance.  According to the AFDO 2001 survey, State and Local Departments of Health and Agriculture conduct more than 2,500,000 food safety inspections at food and dairy facilities and take over 100,000 enforcement actions each year. Federal funding should be adequate, ongoing, allocated based on risk, used flexibly by states to minimize food safety risk, and contingent on federally evaluated attainment of agreed upon food safety outcomes (e.g., program performance standards). This funding should also be directed for training of state and local officials to ensure uniformity in the application of food safety laws and regulations.

NOTE - State and local food safety inspectors perform more than 80% of all food safety work in the United States. While FDA contracts for a very small number of inspections with state agencies, state and local units of government and fees paid by food establishment operators fund most of the nation’s work. In recent times, state and local governments have also struggled with budget reductions. In Michigan, state and local inspectors perform about 117,000 inspections each year and FDA pays the State for 400 inspections. Oregon performs about 16,000 food safety inspections each year and FDA pays the state for 750 inspections.

8.        Double the Value of New Federal Funding by Funding State Regulatory Programs

The food safety bills being proposed by Congress today fail to take into consideration food safety networks already exist within each state – but they need bolstering and support. There is no need to re-create existing infrastructure at the federal level. Utilizing a cooperative agreement model such as EPA uses in pesticide enforcement and USDA/FSIS uses for state meat inspection programs, FDA should provide funding to existing state programs and obtain the following “seamless food safety system” benefits:

a)       Establishment of food safety program standards

b)       Provide national food safety priorities, uniformity and a response network;

c)       Greatly increase the total number of food safety inspections done throughout the nation;

d)       Establish a national food safety communication system and database;

e)       Obtain twice the value in work for the money expended

f)        Accessible and uniform regulator training programs

g)       Allow for a quick response down to the local level throughout the nation, especially important with food safety crisis issues;

h)       Free up the federal agencies to focus on 1) border protection, 2) setting national food safety standards, and 3) cooperative agreement compliance.

9.        Expand Mandatory HACCP to All Food Processing

Government agencies must focus regulatory efforts on preventing or minimizing food safety risks (i.e., verifying the efficacy and application industry designed and operated food safety systems).

NOTE – Food safety management regulations based upon the Hazard Analysis Critical Control Point (HACCP) principle currently exist at the federal level for meat & poultry products, fruit juices, and fishery products. HACCP is recognized as a systematic and prevention oriented control mechanism for dealing with food safety hazards. It should be employed for all food processing types.

Any food safety legislation must acknowledge federal, state, and local contributions in the food safety continuum as well as planning for future resource needs for the nation’s food safety systems. A safer food supply is the result of achieving these goals.

Respectfully submitted,

Gerald Wojtala

President