With the recent rash of safety recalls of imported pet food, millions of toys, and even toothpaste, U.S. consumers have heightened concerns about the safety of all imported products. Hardly a week goes by without a report of some problem with imports. Current programs for insuring the safety of imports are under intense criticism for failure to prevent the entry of unsafe products. In the midst of this gloom, there is one bright spot: the government’s oversight of imported meat and poultry. These products, which potentially are at the highest risk for contamination, in actuality may be our safest imports. This is due to the controls implemented by the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA FSIS).
In order to receive the USDA mark of inspection, all meat and poultry produced in the nation’s nearly 6,000 licensed establishments must be slaughtered and processed under continuous FSIS inspection. Every establishment must implement Sanitation Standard Operating Procedures (SSOPs) and Pathogen Reduction and Hazard Analysis Critical Control Point (PR/HACCP) food safety programs to provide constant assurance that their products meet all current public health requirements. All products are produced under strict requirements for sanitation, ante-mortem inspection, post-mortem inspection, processing procedures, wholesomeness, packaging, labeling, storage, and transportation. Programs are in place to conduct physical, chemical and microbiological testing to assure that consumers are not exposed to unsafe contaminants. Additionally, to assure that consumers are receiving safe and wholesome products, FSIS employs more than 8,500 inspectors who verify daily that establishments are meeting these requirements.
So what is being done to assure that imported meat and poultry products are safe and wholesome? The simple answer is, plenty! Unlike the requirements for most other types of foods, FSIS conducts a comprehensive evaluation of the foreign country’s food regulatory system to assure that they can produce products that meet all of the safety standards applied to similar products produced in the U.S. FSIS uses a combination of document reviews and on-site audits of the exporting country’s inspection system, and port-of-entry reinspections of products at time of importation to assure that all U.S. requirements are being met. Here is a brief review of the requirements designed to ensure that imported meat and poultry products are as safe as their domestically produced counterparts. This multifaceted approach should help convince even the most skeptical critic that the system is effective.
Equivalence Between Nations
Since no two countries implement their respective food safety requirements in precisely the same way, FSIS is required under international law to accept alternative sanitary measures if they provide the same level of protection against food hazards as is achieved domestically. An “appropriate level of protection” is defined as the level of protection from a food safety hazard (i.e., a biological, chemical or physical agent in, or a condition of food, with the potential to cause an adverse human health effect) that is deemed appropriate by a country in establishing a sanitary measure to protect human life or health within its territory. This is also referred to as the “acceptable level of risk,” which is a societal judgment of what risk from food safety hazards is acceptable to the majority.
The concept of food safety equivalence was introduced by the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), which is part of the Final Act of the Uruguay Round of Multilateral Trade Negotiations which the U.S. signed in 1994. Equivalence is the state wherein sanitary measures applied in an exporting country, though different from the measures applied in an importing country, achieve, as demonstrated by the exporting country, the importing country’s appropriate level of sanitary protection. The SPS Agreement became effective in January 1995 with the establishment of the World Trade Organization to which the U.S. is a member.
Under the SPS Agreement, the U.S. is required to accept sanitary measures of an exporting member country as equivalent to our own if the exporting member country demonstrates that its sanitary measures attain the same level of protection. Specifically, a sanitary measure is defined as: “Any measure applied: (a) to protect animal life or health from risks arising from the entry, establishment or spread of pests, diseases, disease-carrying organisms or disease- causing organisms; (b) to protect human or animal life or health from risks arising from additives, contaminants, toxins or disease-causing organisms in foods, beverages or feedstuffs; (c) to protect human life or health from risks arising from diseases carried by animals, or products thereof, or from the entry, establishment or spread of pests; or (d) to prevent or limit other damage from the entry, establishment or spread of pests.
The U.S. has the right to set any level of sanitary protection we feel is appropriate. It is the responsibility of the exporting country to demonstrate to FSIS officials that its sanitary measure achieves the same level of protection. The U.S. has the final decision as to whether or not the exporting country’s sanitary measure(s) is equivalent.
Some examples of sanitary measures are:
• End product criteria, such as tolerances for animal drug residues
• Product-related processing or production methods like HACCP
• Testing, inspection, certification or approval procedures
• Relevant statistical methods used for analyzing effectiveness of program activities
• Procedures for sampling product for contamination
• Methods of risk assessment
• Packaging and labeling requirement directly related to food safety
Initial In-Country Approvals Required
A significant aspect of imported meat and poultry products that many people may not realize is that individual establishments cannot make application to the FSIS to export their products to the United States. The establishment must first make a request to the inspection officials in its respective country. The government of the country then must make a formal written request to the FSIS stating its desire to become eligible to export meat or poultry products to this country.
FSIS responds by providing the foreign officials with information describing all the food safety requirements applied to domestically produced meat and poultry products. At this point, the country is requested to provide a written description of its meat and/or poultry inspection program. Separate reviews are conducted for meat (beef, pork, lamb and goat) and poultry (chicken, turkey, ducks, geese and ratites) because there are separate U.S. laws for regulating the two classes of animals. A country wishing to export both meat and poultry products would undergo a separate review for each. To assist the country in identifying what information to provide, FSIS sends a series of questions addressing the control of animal diseases, sanitation procedures, slaughter and processing controls, microbiological and chemical residue prevention programs, and the mechanisms in place to enforce their respective laws and regulations, as well as to prevent economic fraud.
It is important to point out that the animal disease review conducted by FSIS is separate from the animal health review conducted by the USDA’s Animal and Plant Health Inspection Service (APHIS). The FSIS review focuses primarily on zoonotic diseases and the health of animals when they are presented for slaughter while the APHIS review focuses on preventing the introduction of animal diseases into the U.S. Meeting all U.S. requirements in both programs is mandatory for exporting to this country.
FSIS technical experts (and outside experts if necessary) review the country’s submission and assess the adequacy of its inspection program. Frequently, it is necessary for the country to provide additional data to further clarify their legal requirements, operating procedures, and so on.
If the technical experts determine that the information submitted by the exporting country demonstrates their meat or poultry inspection program provides the same level of protection, FSIS will send a team of experts to the country to conduct an on-site inspection. The purpose of this audit is to provide first-hand verification that the programs and activities described in the written documents are being implemented effectively. The team audits all aspects of the country’s inspection program including headquarters organization and staffing, regional offices, local in-plant inspection activities, production establishments, laboratories, cold storage facilities, port security, training capabilities and compliance records.
If the foreign country’s meat or poultry inspection program will meet and enforce all U.S. requirements on a daily basis for products for export to this country, FSIS promulgates a rule declaring the country is eligible to export to the U.S. Countries approved to export meat and poultry products to the United States are shown in Table 1. A complete listing of all countries eligible to export meat and poultry products to the U.S. is published in the Code of Federal Regulations. The FSIS website also provides a listing of eligible establishments in each respective country.
It should be noted that FSIS also has regulatory responsibility for processed egg products, inspecting all egg products except those that are specifically exempted by the Egg Products Inspection Act. As with meat and poultry products, egg products cannot be imported into the U.S. unless the exporting country has demonstrated that their egg products inspection system is equivalent to U.S. requirements. Currently, Canada is the only country approved to export egg products to the U.S.
Every shipment of imported meat and poultry must enter this country through an FSIS approved import inspection facility. After the shipment has met U.S. Customs and Border Protection and APHIS requirements, it is reinspected by an FSIS import inspector. This reinspection ensures that the exporting country certificates are authentic, accurate and that the products meet all U.S. food safety and quality requirements. The inspectors then examine each shipment for general condition and verify that the product is properly labeled.
Inspectors will conduct several additional inspection procedures on randomly selected shipments. These shipments are selected by the Automated Import Information System (AIIS), a centralized computer database that stores reinspection results from all ports-of-entry for each country and establishment. These additional procedures include net weight checks of retail packages; examination of the container’s condition; examination for product defects; incubation of canned goods; and laboratory analyses for production dcomposition, microbiological contamination, drug and chemical residues, physical contamination and species verification.
The AIIS program is designed to select shipments for reinspection based upon the compliance history of the establishment that produced the product and overall performance of the country. If a shipment fails reinspection, that information is entered into the AIIS database. The system will automatically trigger an increased level of inspection of subsequent shipments from that establishment, regardless of the port at which they may enter. This increased level of reinspection continues until a pre-determined number of shipments are received with no additional problems.
Products that fail inspection are denied entry into the U.S., and depending upon the reason, may be re-exported, converted to non-food use or destroyed. Products that pass inspection are stamped with an official mark of inspection and are permitted entry into the United States.
Ongoing Verification of Equivalence
It is important to remember that port-of-entry inspections are conducted on products that have been inspected and passed by an equivalent foreign inspection system. In addition to providing another layer of public health protection, FSIS utilizes these inspections as verification that the exporting country continues to conduct an equivalent inspection system. This is just one of the initiatives the FSIS conducts to verify that countries continue to produce products which meet U.S. standards.
FSIS has a staff of experienced inspectors who conduct food regulatory system audits in every country that is exporting meat or poultry products to the United States. The focus of these audits is guided by the export history of each respective country. The agency uses knowledge collected during previous audits, results of port-of-entry inspections, and any other information it can obtain to develop an audit plan that will provide an accurate assessment of the country’s current ability to continuously meet our sanitary requirements. The inspectors routinely audit the following activities: government inspection activities at the national, regional and local level; government and private laboratories conducting chemical and microbiological analyses; establishments that are approved by the government inspection program to export to the U.S. These establishments may be randomly selected or specifically chosen because of previous inspection issues.
During the course of the audit, the inspectors observe inspection activities and pay particular attention to how the foreign government inspectors and establishment personnel address food safety hazards. A significant amount of time is devoted to reviewing establishment records relating to implementation of SSOPs and HACCP requirements. The auditors correlate these findings with the records of the government inspectors as part of their assessment of the effectiveness of the inspection program. Prior to leaving the country, the auditor will provide government officials with an oral report describing his/her observations.
Following the audit, FSIS conducts an assessment of all data collected on site. Technical experts determine whether the food sanitary measures of the country continue to provide the same level of protection. A draft audit report is prepared and shared with the government of the exporting country to allow them the opportunity to comment on the findings. After consideration of the country’s comments, FSIS prepares a final audit report. If any issues of concern have been raised as a result of the audit, FSIS and the government of the exporting country will develop a mutually agreed upon action plan. FSIS will track these items until final resolution and verify all of the country’s actions during the next audit.
Sanctions When Necessary
In addition to rejecting product at port-of-entry, FSIS takes other actions to assure that unsafe product does not entry this country. It is the responsibility of the government inspectors in the exporting country to approve only those establishments for export that can produce products that meet all U.S. requirements. If port-of-entry inspectors identify multiple problems with products from an individual establishment or if FSIS auditors find any establishment that does not meet U.S. requirements with regard to the safety of meat or poultry products, then those establishments are delisted and prohibited from exporting until they meet our requirements. The country must submit documentation to FSIS demonstrating that all necessary corrections have been made and, in most cases, FSIS inspectors will audit the establishment before it can again export to the U.S.
If there are repeated instances of a country permitting establishments with minor deficiencies to export, FSIS will not permit any establishments in that country to export without first auditing them. This situation occurs when there are problems associated with deficiencies that do not directly affect the safety of the food, such as inadequate recordkeeping or poor maintenance of facilities.
When a history of problems with multiple establishments in a country indicates that the inspection system cannot guarantee that meat and/or poultry products can be safely produced, then the entire country will be suspended from exporting to the U.S. In order to be reinstated, the country has to provide documentation that every aspect of its inspection system will meet all U.S. requirements. Following a successful document review, an FSIS team will again conduct a comprehensive audit to verify that the country can once again meet U.S. requirements. Only after FSIS officials are firmly convinced that the country will be able assure safe and wholesome products that are continuously produced under a system equivalent to U.S. requirements will its export goods be accepted.
Consumers Can Be Confident
Unlike most other foods imported into the U.S., every shipment of meat and poultry is inspected and passed by an FSIS import inspector. This is actually a reinspection of products that have been inspected and passed under a foreign inspection system that has been verified as being equivalent to FSIS’ domestic inspection program. Foreign inspection programs and establishments are audited regularly to verify that they are meeting all meeting all U.S. requirements. Those nations that do not are prohibited from exporting to this country. Any system can always be strengthened, but consumers should have a high degree of confidence that current efforts to assure the safety and wholesomeness of imported meat and poultry products are working.
Read the sidebar "A Recent Case of Import Inspection Gone Right"
Gary E. Stefan, an Associate with HACCP Consulting Group, LLC, has more than 30 years combined food safety regulatory experience with the USDA Food Safety Inspection Service (FSIS) and the U.S. Food and Drug Administration (FDA). As Senior Equivalence Officer with the FSIS Office of International Affairs (OIA), Stefan evaluated the meat and poultry inspection programs of foreign countries to determine their equivalence with the U.S inspection program requirements. This included leading teams conducting in-country audits of the systems being implemented by those countries seeking approval to export products to the U.S.
Prior to joining the OIA, Stefan was Deputy Director of the Animal Production Food Safety Staff at FSIS where he administered national programs to develop the scientific basis and capacity for decision-making, implementation, and evaluation of food safety programs. These activities focused on supporting implementation of the farm-to-table initiatives of the Pathogen Reduction/HACCP Systems Final Rule, and coordinating efforts to identify practices that reduce or prevent human pathogens and illegal residues on or in meat, poultry and eggs.
While with the FDA, Stefan planned, directed, and managed the Center for Veterinary Medicine’s national initiatives to persuade and motivate regulated industries to accept/participate in self-inspection and other quality assurance programs developed to ensure food safety. Stefan can be reached at firstname.lastname@example.org.
A Recent Case of Import Inspection Gone Right
In early November 2007, the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA FSIS) instituted additional import requirements for meat and poultry products from Canada, including increased testing for Salmonella, Listeria monocytogenes and E. coli O157:H7 and increased levels of reinspection by FSIS at the U.S. border. FSIS also announced that it would immediately audit the Canadian food safety system, focusing on Ranchers Beef, Ltd. and other similar establishments exporting beef to the U.S., based on information provided by the Canadian Food Inspection Agency (CFIA).
FSIS had previously identified this Canadian plant, which has ceased operations, as a likely source of the multi-state outbreak of E. coli O157:H7 infections linked to the Topps Meat Co. As the result of that recall investigation, FSIS delisted Ranchers Beef, Ltd., Canadian establishment number 630, on Oct. 20, 2007, due to unsafe practices and inadequate testing.
The agency stated, “These measures are being taken to further ensure the equivalency of the system already in place. We continue to work together with our food safety partners both domestically and internationally to ensure imported meat and poultry products are produced under systems at least equivalent to those in the United States.”
By Nov. 27, however, William James, Acting Assistant Administrator of FSIS’s Office of International Affairs, issued a letter to William Anderson, CFIA’s Director Meat Programs Division, advising that FSIS would “resume normal levels of product examinations of exported Canadian meat and poultry products, and pasteurized egg products at U.S. import houses,” as well as normal levels of testing for Listeria monocytogenes and Salmonella in ready-to-eat products.
“FSIS will continue testing of raw ground beef, raw beef manufacturing trim, boxed beef, and subprimals normally sent for grinding for E. coli O157:H7,” James wrote. “Testing for E. coli O157:H7 will proceed at levels to be determined after completion of an analysis of eligible imported beef products from all equivalent countries.”
James stated that two audits were completed under the FSIS reinspection program. One audit reviewed investigative actions by the Canadian Food Inspection Agency of unsafe practices of Ranchers Beef, and recall events associated with that establishment. A second audit conducted a follow-up review of seven Canadian establishments that were either delisted or received Notices of Intent to Delist during FSIS’ May 1-June 6, 2007, audit of Canada’s inspection system, and reviewed beef slaughter establishments similar to Ranchers Beef with regard to start-up and operations. “The audits indicated the unsafe practices in Ranchers Beef were not employed by other establishments,” James wrote, “and that corrective actions were in place in the seven establishments identified in the audit earlier this year. Additionally, the increased testing has not revealed any problems with Canadian products exported to the United States.”