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Consumers in the United States enjoy the safest and healthiest food supply in the world. The foundation of this success is our system of food safety and inspection laws. Important federal regulatory programs have been effectively applied in recent years to improve all segments of our extensive food safety system, including food production and distribution chain, animal and plant husbandry, processing, transportation, and preparation. Recently there has been increased interest in nutrition policy. It is recognized that healthy and nutritious products are critical to preventing cancer and other diseases, reducing obesity and diabetes, and maintaining overall good health.
The U.S. food safety system should be consistently reviewed and updated. Reform should be based on risk, as well as the best available, scientifically-proven technologies, such as irradiation. It should eliminate duplication and improve efficiency. It should ensure consistency between federal agencies, and afford state regulators and industry a forum in which to seek clarification when information is inconsistent. Reform should also retain those elements of current laws which meet the current-science standard, and which have assured the U.S. the safest food supply to date.
Today’s global economy and threats of terrorism require that we take a new look at how we ensure a safe food supply in the United States. Our food supply could provide a vulnerable point for intentional acts of terrorism. However, because we source food products from all corners of the globe, we also increase our vulnerability to pathogens, contaminants, adulterants, diseases and a myriad of food quality issues. The U.S. is well-positioned to address these threats by improving the way that federal, state and local food protection agencies work together. The answer is an efficient and effective, integrated, seamless food safety system. Such a system leverages resources that already exist at all levels of government, it clearly defines roles and responsibilities, it allows for maximum information flow between government agencies, it recognizes and accredits the expertise of all parties, and it results in higher degree of uniformity and protection across the nation’s food safety programs.
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:
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:
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:
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.
Food Recall Management—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.
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.
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 cannot 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.
For example, 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.
FoodShield– The National Communications Platform for ALL Food Protection Stakeholders
Rapid and accurate communications between federal, state, and local officials and industry is the foundation of a successful response to minimize the public health and economic impact of any food emergency. The need for improved communications between all stakeholders is commonly cited in lessons learned from real events and exercises. The FDA and USDA must require all federal, state, and local food regulators, public health officials, and other agencies with a role in food protection to use a central communications platform.
FoodSHIELD allows the diverse groups of regulators, public health officials, laboratories, industries, academia, and other stakeholders that are responsible for protecting the nation’s food supply to interact and function as one unified network. The result will be enhanced emergency preparedness, identification, response, and recovery efforts to minimize the public health and economic impact of any food emergency. Multiple layers of security exist within FoodSHIELD allowing users to securely share information with a targeted audience. Communication tools including workgroups for sharing documents, polling tools for obtaining situational awareness, 24/7 emergency contact directory, and webinars for training and meetings build the partnerships necessary before, during, and after an emergency.
FoodSHIELD is the premiere national communication, collaboration, education, and training tool among the farm-to-table food and agricultural sectors. However, the lack of investment and promotion by Federal counterparts has limited its adoption. NASDA recommends further promotion, adoption, and funding of FoodSHIELD as the national communications platform for all food protection stakeholders.
NASDA believes that 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. The promotion of ISO 17025 accreditation by providing funds to meet and maintain accreditation will exponentially increase the Nation’s laboratory capability and capacity and allow for international acceptability of data.
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.
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.
The Food Emergency Response Network (FERN) is a nationwide network of federal and state laboratories capable of testing foods for biological, chemical, and radiological contamination. The FERN network builds vital analytic surge capacity for responding to a terrorist attack on food. NASDA supports efforts to expand the FERN system through cooperative agreements and technical support to states.
More effort needs to be placed on finding effective ways to inform consumers of risk without relying solely on warning statements placed on food products. Criteria need to be established on which to base justification for warning statements or any other disclosure about a food product. Food label claims must be both true and not misleading. Labels are powerful ways to inform, persuade, frighten or misinform consumers and care should be exercised to require only information that represents a material fact. Warning information should only be required when warranted by experimental or clinical evidence.
The United States food supply is rapidly changing as consumers demand diverse and minimally processed foods. At the same time, the number of people at high risk for foodborne illness (pregnant women, individuals with compromised immune systems, the elderly and the very young) has never been higher. Unfortunately, food safety educational efforts have not kept pace.
Consumers frequently cannot evaluate microbiological risks when they are purchasing food products. Organisms such as E. coli 0157:H7 can cause severe illness when a susceptible individual consumes even a few organisms. Consumers have no way of knowing when low level contamination is present and they must rely on government agencies and the food industry to ensure that the foods they purchase are safe. Although outbreaks of severe illness are relatively rare, when they do occur, they are often associated with consumer feelings of outrage and broken trust.
Warning and safe handling labels are used to inform consumers of potential foodborne illness risks. Food producers are reluctant to have their products publicly linked with foodborne illness and prefer more general food safety educational approaches, such as the "Fight BAC" campaign. A 1996 consumer survey conducted by the Food Marketing Institute suggested that consumers take action to reduce their risks of foodborne illness in response to information contained in safe handling labels. Sixty five percent of consumers participating in the survey indicated the labels made them more aware of food safety issues. However, only 43% reported changing their behavior based on this information. It was not determined if the behavioral changes were maintained over a long period of time. The most commonly reported changes were:
Disparagement of Ag Products
NASDA supports laws and regulations that requiring factual information be used when making allegations against agricultural products and/or producers will protect the industry and enhance the general public welfare by prohibiting the dissemination of false, disparaging, and economically damaging information.
Apple growers were financially devastated in 1989 by the highly-publicized Alar scare. It was later determined that disseminators of the sensationalized allegations against apples had no recognized, scientific data to validate their charges. This prompted agricultural interests aggrieved by the apple scare to seek ways to deter such efforts in the future. One option, which several state legislatures have enacted, is to promulgate legislation protecting producers from unfounded scare campaigns. Biotechnology is an emerging tool that will likely become an important part of agriculture’s future, resulting in the development of a host of new food products. This technology and its products are and will continue to be the subject of emotionalized, undocumented, unscientific attacks by certain organizations. To prevent this situation from occurring, the free flow of agricultural products and the financial security of producers must be protected.
Public education should include a general, science-based food safety program directed toward all consumers and target programs for those persons at high risk for foodborne illness. Consumer education should also provide information on technological advances, such as irradiation and agriculture biotechnology that can enhance the safety of the food supply, to promote wider consumer acceptance of such beneficial progress. Federal law should also provide consistent information regarding warning labels and other information statements on food products.
The final control in any system of food safety rests with the consumer. Observations in the United States and other countries have demonstrated that the incidence of foodborne illness can dramatically decline as a result of active public education and effective media coverage. Government and industry must share the responsibility for educating consumers on appropriate food handling and cooking practices.
While it is important to make information available to sensitive populations, statements that are required on some products, but not on other similar products, lead to confusion and misinformation about those products. NASDA would welcome the opportunity to work with federal policymakers on a consistent label and information policy for food products.
MFRPS is currently being piloted in five states, such as North Carolina. The goal of MFPRS is to establish equivalency among the state regulatory programs by identifying key elements of a high quality regulatory program such as laboratory, resources, inspection program, outreach, training, etc. NASDA encourages states to participate in MFPRS and urges FDA to provide additional funding for states to fulfill the requirements of the standards.
Mandatory HACCP plans should be required for all post harvest wholesale processing operations. Each wholesale food processing facility should develop a HACCP plan to control, monitor, and verify the critical processes that are conducted in that operation. Plant operators and plant employees should be responsible for implementing these plans and taking control of the food production processes in their operations. The Secretary of Agriculture and states should monitor and verify the implementation of those plans.
It is important to note that not all establishments must have a HACCP plan. NASDA believes all processors should conduct a "hazard analysis" of their operation. Where significant hazards are identified, then a HACCP plan is required. Many establishments will not have significant hazards and would not need a HACCP plan.
The most significant reduction in risk of foodborne disease can be made by controlling the processes that occur during post harvest production. Processing includes the wholesale and retail handling and modification of plant and food products after the harvest phase and prior to consumption. Wholesale processing includes meat and poultry processing, egg product processing, and further processing of other food products for wholesale and distribution in commerce. It also includes cooking, baking, heating, drying, mixing, churning, separating, extracting, cutting, freezing, or otherwise manufacturing a food or changing the physical characteristics of a food, and the packaging, canning or otherwise enclosing such food in a container, but does not mean the sorting, cleaning, or water-rinsing of a food. Retail processing includes the handling of foods at restaurants, retail stores, vending operations, and other institutions. The steps that are taken at these facilities pose risks to consumers.
NASDA supports requiring those facilities involved in animal harvest to develop and implement written HACCP plans, which identify and control public health hazards for products of animal origin during harvest. The plans should encompass ante-mortem and post-mortem procedures in addition to other identified critical control points (i.e. dressing procedures, sanitation, facility requirements, etc.).
Harvest activities include the conversion process from a live animal to a carcass, the removal of plant material from its growing media, and the harvesting, picking, or collecting of a raw agricultural product or seafood. Once a facility’s plan has been satisfactorily implemented, the Secretary of Agriculture should focus efforts on verifying the effectiveness of the facility’s plan and the facility’s compliance with it. The intensity of government oversight should depend upon many factors including the risks presented by particular products and slaughter operations, the effectiveness of a facility’s plan, and each facility’s compliance with the plan. In facilities that slaughter a uniform, high quality animal, produced under an effective, well documented quality assurance program, the Secretary should not be required to provide 100 percent evaluation of the animals for disease or aesthetic defects (organoleptic inspection). The facility should assume this responsibility as a part of its HACCP plan. A HACCP system developed and implemented by the establishment which could include government verification and minimal inspection oversight would be superior to continuous organoleptic inspection used alone. Facilities harvesting animals that are not uniform and/or of high quality or originate from farms that do not have an effective quality assurance program should still be subject to 100 percent evaluation of animals by the Secretary for disease or aesthetic defects. Facilities involved in plant material harvest should follow HACCP-compatible good agricultural and sanitation practices.
NASDA supports development of uniform, but voluntary standards for pre-harvest food safety, with input from all parties and a clear articulation of the risks and benefits associated with adoption of those standards. Basic and applied research is needed to define specific interventions that will positively impact food safety, and which can be used in the development of uniform standards. Moreover, pre-harvest food safety efforts should also be integrated with overlapping issues such as nutrient and waste management, environmental protection, rural economic development, and animal health and welfare.
NASDA encourages continued work on the Federal/State National Auditing Alliance to verify good agricultural practices and good handling practices. NASDA also supports the concept, similar to the approach used for environmental protection efforts, to provide federal support and incentives to producers who voluntarily establish verifiable pre-harvest food safety programs. NASDA proposes a Food Safety Quality Assurance block grant program, administered by the states, to facilitate the adoption of innovative food safety assurance programs on farm. In addition, there is a need for uniform education regarding the national program to Retailers and International Market Buyers of the USDA Federal State Program. NASDA requests that USDA AMS Fresh Products Branch begin an educational campaign to inform retail buyers of the program and the advantage of the uniformity provided by the Federal State Auditing Program.
Pre-harvest food safety relies on activities conducted by livestock and crop producers which prevent or reduce the occurrence of organisms, agents or conditions that pose an animal health or food safety risk. Most current regulatory programs, however, are focused on post-harvest food safety practices (transportation, processing, retail sale). NASDA believes measures can be taken at the farm level to minimize or reduce the potential for foodborne illness further down the processing chain. We believe this because such measures are successfully being taken in many cases.
Many food retailers and distributors are now calling for third-party food safety inspections of their producer suppliers. In these instances, producers engage the services of a third party to verify that plant and animal production is occurring in accordance with a set of standards. The on-farm standards used vary among states, third-party verifiers, buyers, as well as by crop or animal produced. Consistent standards are needed to ensure that food producers can ensure food safety, satisfy consumer concerns, address the emergence of new organisms and satisfy current and potential export markets. On-farm quality assurance standards should be voluntary, well conceived, sustainable over time, flexible, transparent, uniform and include an evaluation mechanism. Many states are already moving forward to design and implement effective producer-oriented quality assurance programs. For example, the California Department of Food & Agriculture is participating in several on-farm quality assurance programs. The structure of the programs and degree of involvement varies by commodity and their unique needs. More basic and applied research, as well as educational efforts, is also needed.
Incentives, technical assistance, and a comprehensive approach can be used to increase the speed and the extent that standards are adopted on farms. Because of the nature of food handling activities on farms, a comprehensive, integrated approach is needed for ensuring that standards are utilized. Verification that food safety standards are being utilized effectively can be accomplished in a number of ways including third party, HACCP, an overarching audit, or by epidemiological indicators.
While NASDA supports the use of HACCP programs along the complete "farm to fork" continuum, we recognize that there are major gaps in knowledge and information, making it effectively impossible to implement in some areas. In particular, we know little about effective intervention at the farm production level; therefore it is unwise to mandate HACCP programs. However, with sufficient research we believe it possible to identify strategies that will significantly reduce the incidence of on-farm foodborne contamination. Furthermore, it is critical to have an effective transfer of technology and information to the farm. Coordination of research efforts is necessary between state and federal agencies. Enhanced disease reporting procedures would allow agencies to identify research needs at an early stage
NASDA believes 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).
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.
In order to provide efficient utilization of current resources, risk assessments must be made in all segments of meat, poultry, exotic, and aquatic food production, and resources should be allocated in areas where significant risks to consumers can be reduced.
The production of wholesome food for consumers is a cooperative effort between the food industry and governmental agencies. In order to be successful, a sincere spirit of cooperation between the food industry and the government is essential. The incorporation of HACCP plans into the industry must change the way the Secretary of Agriculture allocates resources for inspection.
While HACCP has primarily been required in the meat, poultry, exotic animal, and aquatic industries, HACCP’s application is much broader than just food inspections. HACCP has proved effective in canned food processing, and HACCP or HACCP-compatible systems should be applied to all food production and processing. General guidelines to assist producers, processors, and distributors in HACCP plan development should be available. Testing should be used as a tool to verify the effectiveness of HACCP plans.
HACCP programs can result in enormous safeguarding benefits for the food system, however, it requires a resource commitment on the part of industry. Government agencies should support the movement towards HACCP systems in the food industry. Support could be in the areas of training, research, model plans, and other tools to assist the industry in HACCP implementation.
These HACCP plans must be unique for each operation. Critical control points should be identified, critical limits established, and corrective action procedures developed for processes that are outside of acceptable limits. These plans must be reviewed and updated on a regular basis. Flexibility is necessary in preparation and implementation of these plans. The Secretary of Agriculture and state meat and poultry inspection agencies should monitor the overall effectiveness of these industry plans. A sincere sense of cooperation and collaboration between the industry and the government is essential for a successful risk-based inspection system.
While NASDA supports the use of HACCP programs along the complete "farm to fork" continuum, we recognize that there are major gaps in knowledge and information, making it effectively impossible to implement in some areas. In particular, we know little about effective intervention at the farm production level.
Modernization of the nation’s meat, poultry, and seafood inspection system must be based on the principal idea of reducing the risks of foodborne disease to consumers. Inspection programs should provide oversight that focuses on prevention of food safety hazards. Risk-based inspection will lead to overall safer products by focusing scarce inspection resources in areas with a greater risk potential. Government resources can then more efficiently be directed at ensuring that the hazard control procedures achieve the program’s objective through monitoring and verification of the industry’s activities.
The main value of a Hazard Analysis and Critical Control Point (HACCP) system is prevention rather than detection. The HACCP system involves determining points along the food production chain where contamination can occur. Safeguards are then developed for these critical control points to prevent food safety hazards. Records are kept to help trace problems to their origin. Verification systems are established to ensure that the program is effective.
Therefore it is unwise to mandate HACCP programs. However, with sufficient research we believe it possible to identify strategies that will significantly reduce the incidence of on-farm foodborne contamination. Furthermore, it is critical to have an effective transfer of technology and information to the farm. Coordination of research efforts is necessary between state and federal agencies. Enhanced disease reporting procedures would allow agencies to identify research needs at an early stage.
A national risk assessment model must be developed at the federal level for use in conducting risk assessments of commercial food handling operations from farm to retail. A voluntary Model Food Defense Code should be developed to ensure that states have the tools necessary to close gaps identified through risk assessments. NASDA supports the development of uniform food safety regulations and policies that also permit a certain degree of state flexibility to promulgate regulations that address circumstances that may be unique to that state. In general these regulations and policies should be applied in a consistent manner across federal, state and local agencies. However a necessary first step in the introduction of uniform nationwide food safety policy and the prioritizing of resource allocation is the need to develop sound scientific information on which to base that policy.
The model should be suitable for use in assessing the risks associated with both accidental and intentional contamination of our food supply and should take into account both food safety and food defense. Standardized risk management procedures based on risk assessment results should be used to weigh policy alternatives and to develop and implement the appropriate regulatory response. An active risk communication network should be established to facilitate the exchange of information among those in industry and government who are assessing risk or developing methods to mitigate or manage risk.
The development of standardized food safety protocols embodied in the Model Food Code have enabled jurisdictions at all levels to establish a uniform system of regulation to ensure that food is safe for consumers. The very real threat of an attack on the food supply demands that additional measures be taken to ensure that food offered for sale has been handled under the most secure conditions from farm to table.
Microbiological testing, as necessary to verify the effectiveness of an establishment’s procedures for controlling microbiological hazards, should be an integral part of the risk-based system. This testing should be done to determine if the process is effective and not attempt to establish microbiological standards. The frequency of testing required should be proportional to production volume and frequency of detection, and not based on a calendar schedule.
A significant difference exists between microbiological testing in raw and ready-to-eat foods. Science and technology indicate that it is currently impossible to ensure that raw meats and poultry are free of potential pathogens. As a result, microbiological testing of raw meat and poultry for other than informational purposes and verification of HACCP systems is inappropriate. Microbiological testing in ready-to-eat foods is appropriate and should continue to be mandatory.
No magic risk number can substitute for informed and thoughtful consideration by accountable officials who work with the public to make balanced decisions. Public officials play a key role in determining which involuntary threats to human health are unacceptable and which are acceptable based upon the best available science and not just perception.
NASDA supports the development of uniform food safety regulations and policies that also permit a certain degree of state flexibility to promulgate regulations that address circumstances that may be unique to that state.
No subject is a greater source of misinformation and public confusion than the assessment of relative risk to human health, safety, and the environment. The mathematics of probability is not easy to understand. It is difficult to distinguish the relative difference in the degree of risk between a probability of one in 10,000 and a probability of one in 1,000,000. The issue is further complicated when seemingly qualified scientists dispute the underlying data and assumptions upon which risk calculations rest. Even when the science of risk assessment is crystal clear, there are still value judgments to be made about which risks deserve the highest priority and how safe is safe enough.
Generally, when public health issues are ranked by experts, microbial threats are a greater problem than chemical hazards. However, both chemical and biological hazards present separate potential public health problems that must be addressed in the nation’s food safety policy. While microbial threats are often manifested in immediate, acute reactions ranging from gastrointestinal upset to death, chemical threats may take a lifetime to manifest themselves as disease or genetic changes that affect the next generation. Both problems demand a diligent and effective response from state and federal governments.
In general these regulations and policies should be applied in a consistent manner across federal, state and local agencies. However a necessary first step in the introduction of uniform nationwide food safety policy and the prioritizing of resource allocation is the need to develop sound scientific information on which to base that policy.
A national risk assessment model must be developed at the federal level for use in conducting risk assessments of commercial food handling operations from farm to retail. The model should be suitable for use in assessing the risks associated with both accidental and intentional contamination of our food supply and should take into account both food safety and food defense. Standardized risk management procedures based on risk assessment results should be used to weigh policy alternatives and to develop and implement the appropriate regulatory response. An active risk communication network should be established to facilitate the exchange of information among those in industry and government who are assessing risk or developing methods to mitigate or manage risk.
A voluntary Model Food Defense Code should be developed to ensure that states have the tools necessary to close gaps identified through risk assessments. The development of standardized food safety protocols embodied in the Model Food Code have enabled jurisdictions at all levels to establish a uniform system of regulation to ensure that food is safe for consumers. The very real threat of an attack on the food supply demands that additional measures be taken to ensure that food offered for sale has been handled under the most secure conditions from farm to table.
Very conservative risk assumptions, which are intended to err on the side of health protection, may frequently result in substantial overestimates of risk. There is a need for improved methods of estimating potential foodborne disease in order to prevent and reduce foodborne illness, while ensuring a strong and viable food industry.
Risk is often put into perspective using numerical estimates, such as "a one in one million chance" of an accident occurring. How are these numbers derived? Many statistics, such as the average person’s risk of dying from accidents and violence, are based on hard actuarial data. In contrast, the human cancer risks resulting from low-level chemical exposure in air, food, and water are rarely based on direct observation of human populations. These figures are typically based on high-dose animal studies, which are then extrapolated to determine risks to humans from exposure to low doses.
Within the field of environmental health, some risks are far less speculative than others. The risks of childhood lead poisoning, indoor air pollution, and occupational exposures to chemicals are relatively well understood by citizens and policy makers. Some of the non-cancer health effects from pollution, ranging from aggravation of asthma to neurobehavioral effects, have a stronger technical foundation than is commonly realized. In contrast, many of the traditionally popular and expensive environmental protection programs have a weak foundation in risk analysis.
NASDA believes FDA should expand the grant program to include additional states. This is the most efficient way to increase the Nation’s capability to rapidly identify and respond to a food safety issue. The grants provide not only training and exercising of RRT members, but also for infrastructure development necessary to support the teams.
NASDA strongly urges the immediate development and implementation of a uniform farm animal identification and tracking system, as well as systems that make possible the identification and tracking of domestic and imported food products.
The need for an ability to track crops, livestock and food products from farm to table cannot be overstated in terms of protecting public health and preserving the economic viability of the food and agriculture industry. Consumer and market demands have already begun driving trends to greater accountability and traceability. Increasing threats from a food safety and animal health perspective alone would be sufficient argument in favor of developing comprehensive product identification and tracking systems. Last summer Canada was, and now the United States is, under a global microscope as we struggle to trace the source of a cow infected with BSE as well as other animals associated with that cow. The specter of terrorist attacks makes the development and implementation of such systems even more imperative. If we require more than a few hours to locate all products associated with a terrorist incident, we risk a massive loss of consumer confidence in the nation’s food and agriculture system. That could have far costlier consequences than the immediate cost of the incident.
An effective preharvest quality assurance program should contain a feedback loop whereby food producers and food processors share relevant information on disease agents and disease incidences, diagnostic procedures and intervention strategies. The various segments of the industries can work together through an effective quality assurance program to identify and implement effective intervention strategies to achieve a safer food supply for consumers.
The Secretary should have some oversight of preharvest activities and authority to trace disease agents through all points of production to the place of origin, or at least to the last point of production. In order to make such tracing of organisms and agents possible, the Secretary should have the authority to require appropriate identification of individual animals and plant material. Such identification can lead to a more effective, rapid recall of potentially contaminated food products along the entire food chain, as well as minimization of illness and/or death resulting from exposure. Such a system also provides increased consumer confidence, while possibly minimizing the economic loss to industry in the event of a product recall. Plant records should identify the grower, and such identification could be coded.
Traceback of foods that are inapparent carriers of potential human pathogens should be for the purpose of developing ecological, epidemiological, diagnostic and intervention information and strategies. Quarantine of farms, however, is inappropriate for potential foodborne pathogens that have a number of host species, are found in the environment, and for which there are no effective preharvest diagnostic procedures or intervention strategies. Should quarantine authority become necessary it should continue to reside with state animal health agencies. Seizures/embargo authorization is necessary to halt the movement of adulterated products in commerce.
The federal government should work closely with state governments and industry to develop an identification system that will address the diversity of production, marketing and distribution mechanisms for fresh and processed food products.
It is also important for consumers and industry, as they move between states, to have the confidence that a consistent and uniform set of minimum standards exists that will ensure the safety of the food they serve and consume. This can be accomplished by having all states incorporate the FDA Model Food Code. The 1997 FDA Model Food Code is a document that provides scientifically based retail food safety advice for food regulatory agencies at all levels of government. It is a living document that will continue to be reviewed and updated on a regular basis through input from state and local food regulatory agencies, industry, academia, and consumers through such forums as the Conference for Food Protection and the Association of Food and Drug Officials. It has received endorsement from USDA, CDC, and various food industry organizations.
In order to assure that the public health of consumers is protected from the sale or distribution of foods which have become adulterated or misbranded, a fully integrated and uniform system of salvaging and reconditioning of these products is needed. The Model Food and Drug Salvage/Recondition Code to regulate food and drug salvage processing plants and distributors should be offered to and adopted by the states. State and federal agencies should require that HACCP or HACCP-compatible plans are in place for all salvage food operations.
Food and drug products can become distressed or non-marketable for a variety of reasons that include but are not limited to natural disasters (floods, tornadoes, hurricanes, etc.), shipping accidents, fires, etc. Some food and drug products can be reconditioned or salvaged safely for redistribution and sale to the ultimate consumer.
NIMs was developed so that local, state and federal responders from different jurisdictions and disciplines can work together in responding to natural disasters, emergencies and terrorism. NIMS provides a unified approach to incident management using the Incident Command Structure (ICS). NASDA believes more efforts are needed to address the communications gap between state and federal partners in the sharing of critical information and intelligence. NASDA also believes the development of rapid communications and incident notification systems should be a top priority and include both public and private sector decision-makers.
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.
All states either have developed or are developing livestock, crop and food emergency response plans. NASDA has developed a model Food Emergency Response Plan through a cooperative agreement with federal partners. The state departments of agriculture and other state government agencies need assistance to develop and implement these plans, along with preparedness training and education. NASDA urges the Department of Homeland Security to provide funding for these activities. We believe it is cost-effective to provide state and local government with a valuable readiness tool to facilitate seamless regional and national responses to food emergencies.