Food Safety and Inspection Service United States Department of Agriculture Washington, D.C.  20250-3700

Office of Policy, Program Development and Evaluation

Meat and Poultry Advisory Committee Staff

Extending USDA's Inspection Program to
Non-Amenable/Exotic Species

The Agency is sharing with the National Advisory Committee on Meat and Poultry Inspection (NACMPI) its completed concept paper on "Extending USDA's Inspection Program to Additional Species." This briefing paper serves as the executive summary. The concept paper presents a conceptual framework that will serve as the basis for further action on considering which species of animals should be added to the list of those that are already amenable to USDA inspection. The paper presents:

• the statutory and regulatory basis for mandatory and voluntary inspection;
• a public health rationale for considering additional species;
• an economic assessment of the costs and benefits of adding to the list of species under mandatory inspection;
• a set of criteria for determining which species should be added to the list; and
• an action plan for further progress on this issue.

Transmission of the revised, completed concept paper represents the culmination of a successful process to involve the NACMPI in framing and addressing key food safety issues.

The Agency currently does not have the regulatory and/or statutory authority to inspect non-amenable/exotic species; the species are "non-amenable" to inspection. However, FSIS has given careful consideration to the NACMPI’s recommendations and is in agreement that additional species (such as ratites, quail, squab, cervidae and bison) should be added to those currently under mandatory inspection in order to be consistent with the USDA vision of a public health, risk-based, seamless Federal/State inspection system.

The process began at the November 1999 meeting of the Committee. At that time, FSIS briefed the Committee on key aspects of the issue. The Committee reviewed the preliminary draft concept paper prepared by FSIS to support discussion and policy development, and discussed key aspects of the issue. The Committee also made recommendations. The NACMPI endorsed the application of criteria for resolving the issue of which animals (and their products) that are intended for human consumption should be subject to mandatory inspection (as outlined in the concept paper). The Committee requested more detail in the paper to address the available public health data and microbiological testing, to reflect economic concerns, and to outline issues pertinent to interstate and international shipment of exotic species and their products. The Committee also asked that the Agency address and resolve the specific issue of nitrites in non-amenable (exotic) species.

At its May 2000 meeting, the Committee was briefed on additional public health and economic information gathered and additional issues identified in the exploration of expanding the list of species under mandatory USDA inspection. The Committee had the opportunity to make additional recommendations and identify additional data needs to be reflected in the concept paper. The NACMPI requested that the concept paper, "Extending USDA's Inspection Program to Additional Species," be revised to incorporate available data and be completed by November 2000. The Committee also asked that FSIS provide the strategy it will pursue in seeking the legislative and regulatory changes that would be necessary to add additional species.

Criteria. The concept paper identifies the following primary recommended criteria for determining the list of exotic animals and birds that should be under USDA jurisdiction and, therefore, subject to mandatory inspection:

• Consumption. The species and its products are used as human food. Data presented in the concept paper show that products from certain exotic species (such as ratites) are consumed by the public.

• Potential public health hazards. There must be sufficient microbiological risk for FSIS to mandate inspection and there must be evidence that inspection can mitigate the risk. Species that are shown to be associated with documented human illness (e.g. zoonotic diseases) should be given priority. There is no question that non-amenable/exotic species can be a vector for agents of public health concern. Available data presented in the concept paper show that exotic species appear to present health risks similar to those associated with meat and poultry products subject to mandatory inspection.

• Exposure. Market size – volume of product produced and volume of product consumed – affects the extent to which the population is exposed to potential public health hazards. Products from the species should be produced and consumed in a large enough volume to make exposure a public health concern (especially to at-risk populations). FSIS, with the help of the Committee, has gathered relevant available data to aid in the estimation of exposure, risk and potential costs and benefits of extending mandatory inspection to certain exotic species.

Additional practical criteria that need to be considered include:

• Inspection environment. An establishment with a grant of inspection must be available and within a reasonable geographic distance. This could be an existing facility with a grant of inspection for slaughtering and/or processing traditional meat and poultry products, or it could be a new facility that acquires a grant of inspection for the purpose of slaughtering and/or processing exotic species. Effective inspection procedures for the exotic species would need to be compatible with current inspection procedures and practices for animals and birds subject to mandatory inspection.

• Limited inspection resources. The allocation of limited inspection resources should be based on the relative food safety risks presented by different animal flesh foods, and the potential benefits of inspection. Market size – the level of production and the level of consumption – affects the amount and efficiency of inspection resources.

Costs. The potential costs to FSIS, to industry and to consumers must be identified and estimated. The concept paper identifies costs, some of which are summarized below:

• Industry potential start-up costs include retrofitting of slaughter equipment and facilities, and costs to meet HACCP requirements, including development of a HACCP plan and HACCP training for plant employees. Because non-amenable/exotic species are not currently considered either meat or poultry, unless they are under voluntary inspection, plants producing them are not yet subject to the entire range of Pathogen Reduction and HACCP requirements. Annual operating costs would include HACCP recordkeeping and the cost of analyzing samples for relevant microorganisms.

• FSIS potential start-up costs include the development of baseline microbiological studies and the subsequent development of performance standards for pathogen reduction; chemical residue testing; the establishment of appropriate testing criteria and procedures and the costs to evaluate the equivalence of foreign food regulatory systems in the area of exotic species. Annual operating costs would include inspection service for approximately 159 federally inspected plants and 342 state-inspected plants, the costs of verifying compliance with the PR/HACCP rule; the loss of user fees resulting from the termination of the voluntary inspection program; and reimbursement to state programs for up to 50 percent of the cost of state inspection of exotic species.

• Costs to consumers are uncertain. For example, if the burden of paying for inspection is removed from industry, companies might be able to charge less for their products. If mandatory inspection improves the marketability of these products but the supply does not expand to meet the increased demand, prices could rise. The exact measure of these shifted costs is not yet known.

Process and relevant legal authorities.

Expansion of the list of meat species subject to mandatory inspection would require both a statutory change and rulemaking. The Federal Meat Inspection Act (FMIA) would need to be amended.

Expansion of the list of poultry species amenable to mandatory inspection is possible without legislative change to the Poultry Products Inspection Act (PPIA); that is, through the public rulemaking process. However, the Agency believes that the language in the Acts should be consistent and, therefore, supports an editorial change in the PPIA to be uniform with the changes to the FMIA.

Amendment of the inspection laws would be appropriate to affirmatively permit interstate and international shipment of exotic species. In April 2000, hearings were held on proposed legislation to eliminate the prohibition on interstate/international shipment of state-inspected meat/poultry. (The Administration had transmitted proposed legislation to Congress.) These amenable species issues may be subject to legislative review, as part of that process. It should also be noted that the House of Representatives approved a provision in the FY 2001 appropriations bill for USDA to mandate ratite and squab inspection, without specifying funding. The bill approved by the Senate does not include a similar provision. As of October 4, 2000, the House and Senate had not resolved their differences on the appropriations bill for Fiscal Year 2001, which began October 1, 2000.

• The Federal Food, Drug and Cosmetic Act (FFDCA) does not specifically address the issue of inspection oversight for any particular species of animal, but does cover "food" in general.

• USDA authority for voluntary inspection of exotic species is derived from the Agricultural Marketing Act and not the Federal Meat Inspection Act or Poultry Products Inspection Act. FSIS regulations identify reindeer, elk, deer, antelope, water buffalo and bison as exotic animals eligible for voluntary inspection. Quail and pheasants are exotic poultry species similar to chickens, ducks, and turkeys -- poultry species for which inspection is required. Because exotic species are not considered meat or poultry under the federal inspection laws, industry must reimburse the government for the cost of inspection.

• State inspection of non-amenable species. Several states now conduct inspection of non-amenable species, as noted in the attached concept paper. Currently, FSIS accepts state-inspected exotic meat products for inclusion in amenable product formulations in federally inspected plants. If exotic animals were subject to mandatory inspection, state-inspected products from exotic species would no longer be permitted to move in interstate commerce. (This obstacle would be removed if legislation currently being considered by Congress were to become law.) Because state inspection of exotic species is not covered by the "at least equal to" requirements of the inspection laws, FSIS does not directly review state inspection programs for exotic species for purposes of audit or state program comprehensive review. However, FSIS coordinates with state programs on exotic inspection issues.

Nitrite use. The consideration of extending mandatory inspection needs to address related issues, such as the use of nitrite/ate. The Committee asked whether nitrite will be permitted to be used in products from non-amenable species if certain exotic species become subject to mandatory inspection.

• The use of nitrite/ate in meat and poultry products is permitted on the basis of the "prior sanction" provision of the Federal Food, Drug and Cosmetic Act (FFDCA). Prior sanctions "grandfather" the uses of additives based on their documented use prior to October 1958. With regard to meat products prior sanctions apply only to the species that USDA regulated prior to October 1958.

• In October 1958, new criteria for determining the safety of additives were established under the FFDCA. These new criteria apply to new uses of nitrite/ate in food; i.e., new uses of additives cannot promote carcinogenesis.

• For several years, the National Toxicology Program (NTP) has been reviewing aspects of nitrite use and issued a draft report in April 2000 for public comment to address public health issues, if any exist. The NTP study results will influence FDA's determination on the future status of nitrites, which would impact their use in additional species not currently under USDA inspection.

Dr. Robert C. Post, Director
Labeling and Additives Policy Division 
(205-0279; fax 205-3625)

Send mail to webmaster with questions or comments about this web site.
Last modified:  November 25, 2002