4.3 Roles & Responsibilities
Our current food safety regulatory system is the shared responsibility of local, state and federal partners. The Food and Drug Administration (FDA) is responsible for ensuring that domestic and imported food products are safe, sanitary, nutritious, wholesome and properly labeled. The primary statutes governing FDA’s activities are the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Public Health Services Act. The FDA establishes regulatory requirements and guidance for assuring that food is safe and not adulterated. State, local and county public health and agriculture departments play a major role in helping FDA carry out these responsibilities by conducting state inspections of food establishments, laboratory analyses of foods, and by taking enforcement action when violations result in unacceptable risk to the public. FDA works with states to set safety standards for food establishments and commodities, and evaluates the states’ performance in upholding such standards as well as any federal standards that may apply.
While FDA has primary authority in the food safety network, there is an entire system of complementary state and local laws working in harmony to protect our national food supply. Because all problems exist locally first, states often act as sentinels for emerging issues and have the ability to rapidly respond, often before such issues rise to the level of national concern, and thus before FDA takes action.
To support FDA‘s statutory authority, state agencies are primarily responsible for the actual inspections, enforcement, training, and carrying out a wide range of other food safety regulatory activities. For example, FDA contracts with states to monitor medicated animal feeds and to investigate incidents of pesticide or drug residues in foods. Approximately 80 percent of food safety inspections in the United States are completed at the state and local level.
These numbers dwarf the activities of our federal partners and demonstrate a real commitment to food safety at the state and local level. States for the most part have greater regulatory authority than FDA, including license revocation, detention (embargo) authority, and administrative penalties. This highly-integrated system has resulted in a more effective and efficient regulatory process than FDA could achieve alone. We use our resources to the utmost in our efforts against food-borne illness, food adulteration, and intentional contamination of our food supply.
State Food Inspection Programs
NASDA believes 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.
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. 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).
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:
- eLEXNET – a secure electronic data sharing system for food safety laboratory data
- ISO Accreditation – an internationally recognized laboratory accreditation program aimed at assuring uniform methodologies for federal, state and local laboratories.
- Directory of Laboratory Capabilities – a compilation that identifies federal, state and local laboratory capabilities in preparation for emergency needs.
- 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.
- Validation of Laboratory Methodologies – a joint federal/state effort to standardize and develop national rapid detection methods.
- Foodborne Illness Outbreak Coordination Guidelines – developed to provide uniform investigational procedures and information-sharing protocols.
- 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.
- Uniform Criteria Workgroup – development of uniform national regulatory program standards.
- Integrated Food Safety Partnership – provides a pilot program that integrates the food safety functions of a state and the FDA.
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.
NASDA believes there is a need to 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:
- Establishment of food safety program standards;
- Provide national food safety priorities, uniformity and a response network;
- Greatly increase the total number of food safety inspections done throughout the nation;
- Establish a national food safety communication system and database;
- Obtain twice the value in work for the money expended;
- Accessible and uniform regulator training programs;
- Allow for a quick response down to the local level throughout the nation, especially important with food safety crisis issues;
- Free up the federal agencies to focus on 1) border protection, 2) setting national food safety standards, and 3) cooperative agreement compliance.
NASDA believes there is a need to expand and fund cooperative agreements. A line item in the federal budget should be established for funding state contracts, partnerships, and cooperative agreements.
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.
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.
Federal preemption of state food regulation under the Federal Food, Drug, and Cosmetic Act should not be allowed. States should retain the right to regulate the food supply in a manner at least equal to or greater than federal standards, and have the authority to regulate food products and food handling establishments not regulated by the federal government. The effect of federal preemption is to take away states’ authority to impose requirements to ensure the safety of the food, drug, and cosmetic supply. States would not be able to impose stricter food safety standards than the federal government.
State Meat Inspection Programs
State and federal meat inspection programs should function together as a seamless system in both intrastate and interstate commerce. The 1967 and 1968 Meat and Poultry Acts prohibit state-inspected products (beef, poultry, pork, lamb, and goat) from being sold in interstate commerce. However, the prohibition does not apply to "non-amenable" products such as venison, pheasant, quail, rabbit, alligator, and a host of others. State-inspected meat and poultry are the only commodities that are restricted from sale across state lines. Removing the outdated 1967 ban on interstate sales would create a more uniform system and enhance consumer confidence in the food supply.
Today there are no real distinctions between federal and state inspection requirements. State meat and poultry inspection programs must equal or exceed the level of food safety for the federal inspection program. This has been verified through USDA’s annual reviews and oversight of state inspection programs over the past 35 years. The question of allowing interstate sales of state-inspected products is a simple fairness issue. Most of the state-inspected meat plants are owned and operated by small business owners. The prohibition on interstate meat sales—the only such prohibition of any food product—disrupts the free flow of trade and restricts the ability of small business entrepreneurs to economically compete in the marketplace. Interstate sales will spur more competition and innovation in the industry by giving farmers and ranchers more opportunities to sell their livestock at a better price. Without change, growing concentration in the processing sector will continue to leave smaller farmers and ranchers with fewer buyers for their livestock and poultry.
Passage of interstate meat legislation in the 2008 Farm Bill will resolve a basic issue of inequity which has existed since 1967. Interstate markets for state-inspected products will spur more competition and innovation in the industry that will provide consumers with more choices in the supermarket. Increased markets will stimulate small business sales, expand rural development and increase local tax bases—all of which will benefit farmers and ranchers, processors, related industries, and consumers.
State Meat Inspection Programs are required to be audited by the FSIS Office of Program Enforcement, Evaluations and Review (OPEER) to be verified as meeting “equal to” requirements set by FSIS. The audit or review process consists of two parts; the self assessment and the on-site audit. Self assessments are written documentation of how a state program implements its program in a manner “equal to” FSIS and are annually submitted to OPEER. On-site audits are conducted every three years to verify the information in the state self assessments. This process has become fundamentally flawed because of three primary issues; FSIS is exceeding its statutory authority by requiring state programs to address all federal directives, notices and policies; FSIS has no standard to measure “equal to” criteria because the audit branch does not review federally inspected plants and; FSIS continually changes its expectations of state programs. It is unreasonable for state inspection programs to be subject to ever-changing expectations and standards. NASDA urges FSIS to develop standards which are applied to federal inspection practices and require OPEER auditors to use those standards as the benchmark for determining “equal to” status of state inspection programs.
NASDA strongly supports an inspection system that is fair and equitable to all segments of the industry. The system must be based on risk, rather than the point of sale or origin of the product.
Traditionally, the Secretary has assumed authority over various segments of the meat and poultry industry based on the type of operations being conducted such as inspection at wholesale operations but not at retail operations. Inspection of the production of meat and poultry food products has been based on the amount of meat or poultry in a product and not on the potential risks of those products.
A more efficient and effective method of inspection would include a risk assessment of the food safety hazards associated with the type of product or processes involved in production. The percentage of meat or poultry in a product should not be the determining factor in a food safety program. The process used to control, monitor, and verify the production of that food is the most important consideration for consumers.
All food entering commerce, both traditional and non-traditional, aquatic and exotic animals, should be included in the inspection process. Many of the currently exempted items pose the same potential health risks as those presently mandated for inspection. With increased productivity, varying consumer preference, and the lack of a consistent nationwide inspection program, exempting meat and poultry food products from inspection as is currently done under the present system cannot be justified.
Redeployment of Federal Inspectors in Retail—In an effort to re-deploy federal inspection staff, USDA has proposed an "in-distribution" pilot test project. Under this proposal, federal inspectors will expand a presence at retail-level food establishments. State and local food agencies have traditional responsibility at this level.
The National Academy of Sciences, in its August 1998 report, "Ensuring Safe Food From Production to Consumption," stated that the ideal federal food safety system would be "organized to be responsive to and work in true partnership with nonfederal partners. These include state and local governments, the food industry, and consumers." The FSIS is testing the feasibility of using its inspectors in food safety activities outside of federally inspected plants. Many of the activities proposed for the "in-distribution" FSIS inspections have historically been conducted by FSIS compliance officers. Responses by the leadership of the Association of Food and Drug Officials (AFDO) and the Food Marketing Institute (FMI) suggest inadequate FSIS coordination with its nonfederal partners for this initiative.
NASDA has urged the USDA, Food Safety Inspection Service (FSIS) to ensure that its food safety initiatives are integrated with food safety activities of its nonfederal partners. Potential impacts if this is not done include:
- Limited federal resources deployed without a systematic evaluation of risk or need
- Duplication of regulatory effort between federal and nonfederal agencies
- Precedent for unilateral federal action without effective coordination with nonfederal food safety agencies.
State Egg Inspection and Quality Assurance
State egg inspection and egg quality assurance programs have worked in cooperation with the table egg industry for many years to reduce the risk of Salmonella enteritidis in shell eggs. As the responsible federal agencies discuss their approach to reducing the public health risk of Salmonella enteritidis in shell eggs, the success and expertise of state programs should be recognized and included. If a mandatory federal program is implemented, the state programs that are equal to the federal program should be accepted. Aspects of quality assurance programs that should be addressed for the egg industry include biosecurity, rodent and pest control programs, environmental and egg sampling, etc. If a mandatory federal program is implemented, the state programs that are equal to the federal program should be accepted.
Dairy Product Safety
As the marketing of dairy products expands further into international markets, NASDA supports milk regulatory agencies utilizing uniform interpretations of the FDA Pasteurized Milk Ordinance and the USDA Milk for Manufacturing Purposes and its Production and Processing Recommended Requirements.
Passage of the GATT and NAFTA agreements are advancing the National Conference on Interstate Milk Shipments (NCIMS) into the area of international trade. State and federal milk regulators and the NCIMS Program must ensure that regulations are uniform and equivalent, providing a safe and wholesome product, while allowing international commerce to progress.
Only pasteurized milk, milk products and properly aged cheeses should be sold for human consumption. Sale includes distribution by use of animal or herd sharing, bartering, exchange or agistment. In those states where the sale of unpasteurized milk is authorized, those products should be labeled "Not Pasteurized and May Contain Organisms that cause Human Disease."
Apparently healthy cows and goats can shed in their milk organisms which are pathogenic to human beings and may cause diseases such as brucellosis, Campylobacter enteritis, salmonellosis, and tuberculosis; and inasmuch as milk handlers may introduce pathogenic agents during the handling of unpasteurized milk (including certified raw milk). As a precondition for the importation of all dairy products (Grade A and Non-Grade A) into this country, the FDA should be required, through legislation or other means, to make a timely determination as to whether a dairy product proposed to be imported meets the sanitary standards of this country. The determination could be made by either (1) inspection of individual plants and farms by FDA or by FDA certified private firms or individuals; or (2) by FDA’s determination that the foreign country’s dairy inspection system is equivalent to that of the United States.
Verification of Food Safety Programs for Fresh Produce and Citrus
NASDA supports the concept of uniform third party audits as a means of verification of produce supplier food safety programs, providing the audit programs are science based, and utilize trained licensed federal or state auditors, or suitably licensed private auditors.
Fresh fruits and vegetables are important to the health and well being of the American consumer. Consumers enjoy one of the safest supplies of fresh produce in the world. However, over the last several years, the detection of outbreaks of food borne illness associated with both domestic and imported fresh fruits and vegetables has increased.
In 1997 the U.S. Food and Drug Administration and the U.S. Department of Agriculture collaborated to produce the "Guidance for Industry" - a guide to minimize microbial food safety hazards for fresh fruits and vegetables. This guidance document (The Guide) addresses microbial food safety hazards and good agriculture and management practices common to growing, harvesting, washing, sorting, packing, and transporting most fruits and vegetables sold to consumers in an unprocessed or minimally processed (raw) form. Both domestic and foreign fresh fruit and vegetable producers can use this voluntary science based guidance to help insure the safety of their produce.
The produce guide is guidance, not a regulation. As guidance, and if applied as appropriate and feasible to individual fruit and vegetable production operations, the guide will help to minimize microbial food safety hazards for fresh produce.
The food retail companies have an ever-increasing awareness of the consumer demand for safe food. Due to this awareness, these companies are requiring their suppliers of fresh fruits and vegetables to adhere to the guidance document and minimize the possibility of microbial contamination to the food supply. The retail food companies are requesting that their suppliers provide verification of their food safety programs through third party audits. The third party audit system in no way provides or implies any assurance that suppliers produce is free from microbial contamination. It is only a means to verify that the producers have a system in place to minimize microbial contamination.
NASDA encourages FDA and USDA to ensure that regulations and inspection methods for imported foods be based on risk-based analysis; that the regulatory and inspection process be applied in a uniform manner by both agencies; that resources for import activities be distributed equally across both agencies; and that state food safety agencies who meet federal accreditation standards be a key partner in the import activities.
International trade agreements have dramatically increased the amount of imported and exported food products to and from the United States. Most trade agreements addressed the issues of non-tariff trade barriers and other mechanisms often used to support domestic production programs. Phytosanitary restrictions, intended to provide safeguards against the importation of new, exotic, or serious pest problems, are still in place and allowable under the trade agreements. However, an issue that has not been adequately addressed is harmonization of food safety standards among trading partners. While the United States has imposed many restrictions on domestic food producers - limiting use of pesticides, mandating production under HACCP plans, mandatory labeling and container requirements - these requirements are not uniformly imposed upon imported products. This creates problems in two areas - uniformity of food safety for United States consumers and economic uniformity among the industry. NASDA strongly encourages the federal government to seek legislative and trade agreement reform that will ensure a uniform standard for food safety on both domestically - produced and imported food products.
All regions of the United States have been faced with significant and continuing problems regarding the safety and threat posed by certain imported foods, and the potential for a bioterrorism threat involving the safety of our foods from deliberate contamination is a reality.
FDA & USDA regulations and inspection methods for imported foods should be based on risk-based analysis. The regulations and inspection methods resulting from this process should be applied in a uniform manner by both agencies. Resources allocated for import inspection activities should distributed equitably across agency lines.
The federal government must assure that all imported food is subject to the same food safety standards required of US food manufacturers. This will require the federal agency with jurisdiction over a particular category of food products to make an equivalency determination in regard to a country’s food safety system for that product before imports are allowed into the US from that country. Additionally the federal agency must also establish appropriate auditing and monitoring systems to assure that the food safety system is operating effectively. Furthermore, for those items that are involved in a previous food contamination and food safety incident, a full risk assessment, analytical testing, and certification of food items should be required by USDA and APHIS before importation of those items.
Repeated incidents involving imported foods including four years of food borne outbreaks from Salmonella poona in imported Mexican cantaloupes, recent findings of chloramphenicol residues in Asian shrimp, other seafood species, and honey in the U.S., Canada and Europe, and the findings of Mediterranean fruit fly in Clementine fruit from Spain illustrate the need for heightened surveillance and inspections.
NASDA urges all states to modify their programs to inspect and test for the food safety problems being noted in the marketplace involving antibiotic residues, food borne pathogens, and pesticide residues, and strongly encourages the federal government to provide needed resources to conduct such programs.
NASDA commends APHIS for action to prohibit the entry of medfly infested Spanish Clementine fruit and urges APHIS to continue this prohibition until adequate medfly-free certification criteria can be implemented. NASDA urges the U.S. Food and Drug Administration to establish systems and procedures to prevent the introduction of food borne pathogens, antibiotic residues, and pesticide residues into the food supply from other nations and to prohibit further importation of products involved in known problems until assurances of contamination problems can be resolved.
The United States still imports milk products from foreign countries without regard to whether those countries have equivalent inspection systems to assure the safety of those products, subject only to spot-checking of these products on arrival in the United States, except in cases where state laws have forced state authorities to establish more stringent controls. The Import Milk Act should be amended to extend the prohibitions applicable to the importation of milk to milk products, so that neither may be imported unless the Food and Drug Administration has conducted its own premises inspection, accepted a foreign official’s certification of the quality of the product in question, or determined that the shipping country maintains a milk and milk product inspection and control system equivalent to that of the United States.
NASDA believes 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.
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.
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.
FDA should provide training for states in imported food issues and fund strategic cooperative agreements with importing states and state laboratories to monitor imported food products marketed domestically.
As authorized by the 2005 Sanitary Food Transportation Act, FDA should write regulations to support an integrated food transportation oversight and regulatory program. The rules should recognize the role of states in their responsibility to assure the protection of food and feed in transit.
An important component of the "farm to fork" food safety continuum is transportation. Food and feed are susceptible to contamination from a wide variety of physical, microbial, and chemical hazards while being held, transported, or delivered. Whether transported by truck, rail, air, or ship, the oversight and regulation of the transportation of food products across our country can be one of the weakest links in the food distribution system.
The 2005 Sanitary Food Transportation Act shifted authority for the regulation of sanitary food transportation practice from DOT to FDA. The Act requires FDA to develop regulations governing the safe transportation of food and food products. As of 2008, those rules have not been developed but FDA has begun the research process that will lead to rule promulgation.
Food protection and defense of in-transit food & feed can be improved by the control of hazards through the use of preventive measures. Those measures include good sanitation practices, tracking & documentation, temperature control, and the use of HACCP systems throughout the distribution chain. Not all current transportation industry practices employ adequate controls. State agriculture agencies can play a large role in safe food & feed transportation using new and existing authorities to focus regulatory attention on this segment of the food supply chain.
The federal government should fund cooperative agreements or contracts with states to monitor food transportation.