Introduction

At the May 1999 meeting of the NACMPI, a preliminary draft concept paper on mandatory inspection of all animal flesh foods was discussed. The Committee recommended the application of criteria for resolving the issue of what animals (and their products) should be involved in mandatory inspection.

FSIS has given careful consideration to the NACMPI’s recommendations and is in agreement that additional species, such as ratites, quail, and squab, 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. In response, a decision was made by the Agency to begin the process of exploring an expansion of the definition of amenable species. Although expansion of amenable poultry species may be possible without legislative change, such an expansion for meat will require amending the Federal Meat Inspection Act (FMIA) to add to the list of species under mandatory inspection.

This paper represents a first step in the process necessary to move toward a legislative proposal to amend the FMIA to add to the list of species under mandatory inspection. This paper presents a conceptual framework that can serve as the basis for determining which species of animals should be added to the list of those that are already amenable to USDA inspection. The conceptual framework is a starting point for further dialogue and prompts questions for which data are needed for a response. The paper presents the statutory and regulatory basis for mandatory and voluntary inspection, a public health rationale for considering additional species, a preliminary economic assessment of the costs and benefits of adding to the list of species under mandatory inspection, and a set of criteria to consider in making the decision as to which species should be added to the list.

Public participation in guiding the Agency in this initiative is also needed. The Agency is interested in the Committee’s views and advice on the course of action on which it has decided to embark. The Agency needs additional data and information on the points raised in this paper and welcomes continued guidance from the Committee in its effort to develop a record to support legislative and regulatory changes.

Background

Statutory and Regulatory Authorities

Currently, statutory and regulatory provisions define the species of animals that are inspected by USDA under mandatory inspection and those that are under voluntary inspection. In certain instances, explicit exemptions from inspection exist, in addition to exemptions from the definitions of products that USDA inspects. States with inspection programs may also inspect the slaughter of animals and the preparation of the meat and poultry products from both amenable and non-amenable species.

The FMIA mandates that USDA inspect cattle, sheep, swine, goats, horses, mules, and other equines, and the food products thereof, slaughtered and prepared in Federal establishments and foreign establishments exporting such products to the United States, that are intended for distribution in commerce (21 U.S.C. 601 et seq.). The Federal meat inspection regulations (9 CFR Subchapter A) implement the provisions of the FMIA. The Federal meat inspection regulations (9 CFR 301.2) define "livestock," "meat," and "meat food products" as being of cattle, sheep, swine, goat, horse, mule, or other equine origin.

The FMIA provides for exemptions from inspection of the slaughter of animals and the preparation of the carcasses, parts thereof, for meat, and meat food products at establishments conducting such operations for commerce when such products are exclusively used by an individual or households and, thus, are not sold. This provision is referred to as the custom operation exemption. The FMIA also provides an exemption from the definition of "meat food product" for products that contain meat or other portions of such carcasses only in a relatively small proportion or historically have not been considered by consumers as products of the meat food industry, and that can not be represented as meat food products.

The Federal meat inspection regulations (9 CFR Part 303) also address exemptions from the requirements of the FMIA with regard to inspection, including custom operations and products that are exempt from the definition of "meat food product."

The PPIA mandates that USDA inspect "poultry," i.e., any domesticated bird, and food products thereof, slaughtered and prepared in Federal establishments and foreign establishments for export to the United States that are intended for distribution in commerce (21 U.S.C. 451 et seq.). The Federal poultry products inspection regulations (9 CFR Part 381) implement the provisions of the PPIA. The Federal poultry products inspection regulations (9 CFR 381.1) define poultry as meaning any domesticated bird (chickens, turkeys, ducks, geese, or guineas), whether live or dead.

The PPIA also provides for exemptions from inspection of the slaughter of poultry and the preparation of poultry products, i.e., poultry carcasses or parts thereof. Among the exemptions, the PPIA provides for the exemption from inspection of the custom slaughter of poultry and the preparation of carcasses and parts thereof at establishments conducting such operations when such products are used exclusively by households and individuals and are not sold. Different than the provisions of the FMIA, the PPIA contains specific criteria for such exemptions based on the volume of poultry slaughtered or processed.

The PPIA also includes an exemption from the definition of "poultry product" for products that contain poultry ingredients only in a relatively small proportion or historically have not been considered by consumers as products of the poultry food industry, and that can not be represented as poultry products.

The Federal poultry products inspection regulations address exemptions from inspection, including an exemption from the definition of "poultry product" of certain human food products containing poultry, such as those containing less than 2 percent cooked poultry meat (9 CFR 381.15), and an exemption from inspection for custom operations (9 CFR 381.10).

The Agricultural Marketing Act of 1946 (AMA) (as amended) provides USDA with the authority to inspect, certify, and identify the class, quality, quantity, and condition of agricultural products (including food animal products) in interstate commerce on a voluntary, fee-for-service basis that covers program costs. The Secretary is also authorized to issue inspection regulations. The Secretary may deny AMA inspection services for failure to comply with regulatory requirements because of the lack of available inspectors or other administrative reasons.

USDA has published regulations for the voluntary inspection of rabbits (9 CFR Part 354) and the voluntary inspection of exotic animals (9 CFR Part 352). Rabbit is defined in 9 CFR 354.1(z) as any domesticated rabbit. Exotic animals are defined in 9 CFR 352.1(k) as any reindeer, elk, deer, antelope, water buffalo, or bison.

The Department has also promulgated regulations related to the voluntary inspection of poultry (9 CFR Part 362). The poultry subject to voluntary inspection regulations are defined in 9 CFR 362.1(d) as any migratory waterfowl, game bird, or squab.

USDA also provides voluntary inspection of ratites under guidelines that were published in November 1995. Ratites include ostrich, emu, and rhea.

Non-amenable species and their products are not specifically addressed under the FMIA and PPIA, except with regard to voluntary inspection of exotic species. Only amenable species are defined in the Acts and implementing regulations. Therefore, there is a commonly held view that non-amenable species fall under the jurisdiction of the FDA in terms of inspection jurisdiction. Although the Federal Food, Drug, and Cosmetic Act (FFDCA), under which FDA operates, does not specifically address the issue of inspection oversight for any particular species of animal, the FFDCA does cover "food" in general. Thus, by default, the FFDCA and its regulations apply to the slaughter of non-amenable species and the preparation of their products.

The FMIA and PPIA authorize the Secretary to cooperate with State agencies in developing and administering State meat inspection and poultry products inspection programs in any State that has enacted a State meat or poultry products inspection program law that imposes mandatory ante mortem and post mortem inspection, reinspection, and sanitation requirements that are at least equal to those under the provisions of the Acts. Under the Acts, establishments in a State with an approved inspection program may engage in the slaughter of animals and the preparation of their products for use as human food for distribution within the State. Currently, establishments under State inspection programs are prohibited from shipping their products interstate.

USDA cooperation with State agencies includes providing advisory assistance, technical and laboratory assistance, and financial aid for the administration of such programs. The Acts stipulate that the amount contributed to any State by the Secretary from Federal funds for any year shall not exceed 50 percent of the estimated total cost of the cooperative program, and the Federal funds are allocated among the States desiring to cooperate on an equitable basis. Currently, there are 25 States with approved inspection programs. Under State inspection laws and programs, both amenable and non-amenable (i.e., exotic species) may be inspected for slaughter and the preparation of the respective products for distribution within the State. In some instances, States may require inspection of certain animal species and their products for intrastate commerce, while others may require Federal inspection before any product can enter their State.

If a State fails to develop or is not enforcing, with respect to all establishments within its jurisdiction, at which amenable species are slaughtered or prepared for use as human food solely for distribution within that State, requirements at least equal to those of the Acts, the Secretary is empowered to designate such States as having to comply with the provisions of mandatory Federal inspection in the Acts. Such States are known as "designated States."

The species of animals slaughtered in Federal establishments under voluntary inspection, in 1998, are listed in Table 1, entitled Non-Amenable Species Slaughtered in Federal Establishments Under Voluntary Inspection - 1998 (Table 1), which is appended to this paper. Table 2 (also appended to this paper) shows data for the production of non-amenable (and exotic) species under Federal and State inspection programs. In many cases, it appears that more non-amenable species of animals are slaughtered under State inspection programs, e.g., animals in the genus Cervidae (deer, reindeer, and elk), than at establishments under Federal inspection. The Tables do not account for non-amenable species slaughtered under custom operation exemption.

Public Health Issues and Implications

The Advisory Committee has not developed a list of animals that are potential candidates for mandatory inspection. However, FSIS regulations identify reindeer, elk, deer, antelope, water buffalo and bison as exotic animals eligible for voluntary inspection. These animals are similar to cattle, sheep, and swine, in that they are all even-toed, horned ungulates (having hoofs), and the concepts of head, viscera, and carcass inspection are easily adaptable from red meat inspection regulations and protocols. In the same sense, quail and pheasants are not that different from chickens, ducks, and turkeys, which are amenable poultry species for which inspection is required. On the other hand, ratites present a slightly different issue in that their size prevents utilization of standard automated poultry lines. Depending on the anatomy of the animal, facilities, protocols, HACCP plans, and other components of the Federal inspection process may need to be restructured, retrofitted, or amended to accommodate new species, if additional species are brought under mandatory inspection.

According to 1998 data compiled by FSIS, voluntary inspection was provided by FSIS to a wide variety of eligible non-amenable species, ranging in anatomical size from bison to quail. Table 1 lists the species for which voluntary Federal inspection was provided in 1998. The Table provides the production in numbers of animals (and birds) slaughtered by species, the number of Federal establishments/plants participating in the voluntary inspection of the various species, and the states where the plants are located. Together with the data in Table 2, this kind of information may be useful in determining exposure to potential pathogens or agents of zoonotic disease which may be associated with a particular species. Such information could be important in projecting potential risk of various populations who might eat animal foods derived from a particular species. The sufficiency or extent of the market, i.e., possible exposure, could be a factor in determining which species, if any, should be brought under Federal mandatory inspection if a public health issue is identified. Later in this paper, the criterion of "sufficiency of market" is discussed as one of several criteria on which to base selections of current non-amenable species for mandatory inspection in the future.

Some exotic species are currently slaughtered and inspected in State inspected meat or poultry processing plants that are not reflected in Table 2. For example, there is a market for meat products derived from wild boar (feral swine) which is used as human food, but wild boar is not included in Table 2. Additional information regarding what other exotic species are being inspected under State inspection needs to be acquired and considered before the Agency can make a determination to extend mandatory Federal inspection to additional species.

The degree to which there is a public health need to extend mandatory inspection to exotic species is uncertain. According to literature reports¹, every year, in the United States, foodborne infections cause millions of illnesses and thousands of deaths, but this situation is not primarily a result of a breakdown in the inspection system.

It is known that more than 200 known diseases are transmitted through food.² The causes of foodborne illness include viruses, parasites, bacteria, toxins, metals, and prions. A recent article published by the Centers for Disease Control (CDC) estimated that, in the United States, foodborne diseases cause approximately 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths each year. Known pathogens account for an estimated 14 million illnesses, 60,000 hospitalizations, and 1,800 deaths. The conclusion of the authors was that "overall, foodborne diseases appear to cause more illnesses but fewer deaths than previously estimated."³; The CDC also concluded that surveillance of foodborne illness is complicated by the fact that (1) incidences are underreported, (2) pathogens dispersed through food are also spread through water or from person to person, thus obscuring the role of foodborne transmission, and (3) some proportion of foodborne illness is caused by pathogens or agents that have not yet been identified and thus cannot be diagnosed. They stated that the importance of this final factor cannot be overstated because many of the pathogens of greatest concern today (e.g., Campylobacter jejuni, Escherichia coli 0157:H7, Listeria monocytogenes, and Cyclospora) were not recognized as causes of foodborne illness just 20 years ago.

Foodborne illness is a multi-faceted cause and effect phenomenon. Further, the epidemiology of foodborne disease is changing. New pathogens have emerged. Many, including Salmonella, Escherichia coli 0157:H7, Campylobacter, and Yersinia enterocolitica, have reservoirs in healthy food animals, from which they spread to an increasing variety of foods. There is no simple or universal way of preventing foodborne disease. Food reaches the consumer through long chains of industrial production, in which many opportunities for contamination exist.

Foodborne pathogens share a number of characteristics. Virtually all have an animal reservoir from which they spread to humans. Many do not cause symptoms of illness in the carriers, e.g., chickens with a lifelong ovarian infection with Salmonella enteritidis, calves carrying E. coli 0157:H7, and oysters carrying Norwalk virus or Vibrio vulnificus. Limited existing research on how animals acquire and transmit emerging pathogens among themselves often implicates contaminated fodder and water; therefore, public health concerns must now include the safety of what food animals themselves eat and drink.

According to a CDC publication⁴, more research is needed to answer questions about whether and how a pathogen such as E. coli 0157:H7 persists in the bovine reservoir, in order to establish the size and dynamics of a reservoir for this organism in wild deer. The CDC publication cites a report of an outbreak of E. coli 0157:H7 attributed to jerky made from deer meat that was also reported in the April 16, 1997 issue of Journal of the American Medical Association (pages 1229-31). These sources reported that it is reasonable to suspect animal flesh foods as having the potential to pose some level of risk to human health. This view highlights a need to determine the extent of the risk and which animals should be included in a mandatory USDA inspection system in order to protect the public.

Strategies to prevent foodborne illness must consider the sources of the possible contamination, and if, and how, an inspection process can be instituted as an effective prevention measure in reducing risk to human health. The difficulty of obtaining indisputable, scientific data linking a specific species harboring a specific pathogen responsible for causing illness or death should not deter FSIS from pursuing a thoughtful approach for bringing new species under mandatory Federal inspection. Such an approach would be precautionary and based on the rationale that any animal used for human food is a potential source for agents that could cause foodborne illness.

Furthermore, the demographics of consumers is changing; there are increasing numbers of elderly or immunosupressed persons who are at higher risk of severe illness, and consumers spend less time cooking than before and many have received less instruction in safe food handling in their home or at school than before. According to the Administration on Aging, by the year 2030, there will be about 70 million older persons, more than twice the number than in 1997. People over 65 years of age are projected to represent 13 percent of the population in the year 2000, but they will represent 20 percent by 2030.⁵ Traditionally, it is the elderly, very young, pregnant and lactating women, and immuno-compromised individuals who are at greatest risk of complications resulting from foodborne illness. It is not known to what extent these populations are likely to eat foods derived from exotic animals. Such information might be helpful in identifying which exotic animal species to include in the mandatory inspection process.

The principles that the Agency should apply in determining the applicability of mandatory inspection to additional species should also consider the allocation of inspection resources based on the relative food safety risks presented by different animal flesh foods and should be hazard-based, science-based, and public-health based. Logistical and practical adaptations of inspection protocols, facilities designs, and equipment to the unaccustomed physical attributes of non-amenable species would play a secondary role and would need to be considered if mandatory inspection is extended to additional non-amenable and exotic species.

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¹Bryan, FL Diseases transmitted by Foods, Atlanta:Centers for Disease Control, 1982.
²Ibid.
³Mead, Paul S., et al., Food-Related Illness and Death in the United States, Emergining Infectious Diseases, Atlanta, Georgia Center for Disease Control, 1999
⁴Emergining Foodborne Diseases: An Evolving Public Health Challenge, Robert V. Tauxe, Centers for Disease Control and Prevention, Atlanta, Georgia, October - December 1997, Volume 3 Number 4
⁵Profile of Older Americans: 1998, Administration On Aging. Population Projections of the United States by Age, Sex, Race and Hispanic Origin: 1955-2050" Current Population Reports, P25-1130, Data compiled primarily from Internet releases of the U.S. Bureau of the Census and the national Center for Health Statistics, Administration On Aging.

Costs of Mandatory Inspection for Additional Species

Recommendations for Criteria in Determining Additional Species to Add to Mandatory Inspection

This concept paper has explored several important issues with regard to extending mandatory inspection to additional species. A key function of this paper, beyond what has already been discussed, is to enumerate some criteria on which to base decisions on whether a species should be placed under mandatory inspection. These criteria, though not exhaustive, will provide a clearer guide to policymakers.

  The Animal and Its Products Are Used as Food for Human Consumption

There is nothing to gain from FSIS regulation of the slaughter of animals that are not used as food for human consumption. Likewise, there is no associated risk of human illness if humans do not consume a particular species.

  There Is Microbiological Risk

There must be sufficient microbiological risk for FSIS to mandate inspection and there must be evidence that inspection can do something about the risk. If pathogens are unlikely to be present, scarce resources can be utilized more efficiently elsewhere.

There Is Scientific Evidence Linking New Species to Human Illness

Microbiological risk does not always translate into human illness. Species that are shown to be associated with documented human illnesses, e.g., zoonotic diseases, should be given priority.

  Sufficiency of Market

The size of the market must be a consideration in the allocation of limited FSIS resources. The level of production and the level of consumption are factors that effect the extent to which the population is exposed to microbiological risk and risks of other diseases associated with animal species not currently under mandatory inspection. They also affect the efficiency of inspection operations, as there must be an official establishment ready to slaughter the animal and do so in sufficient numbers to make inspection efficient (e.g., require at least 1 full-time inspector). This criterion may have a regional component because some species tend to be produced, marketed, and consumed in larger quantities in certain regions of the United States (such as bison is in the West).

Compatibility with the FSIS Inspection System

An establishment with a grant of inspection must be available and within a reasonable geographic location to where animal species not currently under inspection are raised or caught. The establishment must have the requisite staff years of inspection personnel.

Additionally, some species present novel inspection problems. For example, ostriches are typically too large to be processed on the same equipment as chickens. It may be necessary for establishments to retrofit equipment and facilities in order to slaughter and process certain species. Other things being equal, those species that are more compatible with inspection procedures and facilities should be converted to mandatory inspection before those species that are less compatible.

Cost

This criterion ensures that Agency funds are spent efficiently, i.e., on mandatory inspection where social benefits (from improved human health) outweigh social costs. Furthermore, this criterion can be used to prioritize among species even when there are positive social benefits. There are a number of tools that allow for such welfare-improving choices, of which the maximization of net benefits or the maximization of a benefit/cost ratio are examples.

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Application of the Criteria

These criteria can be viewed as a sequence of things to consider from a public health perspective. Applying the criteria would require available data on the production volume of non-amenable species and the locations of establishments where non-amenable species are slaughtered and processed, such as that presented in Tables 1 and 2. Most, if not all, non-amenable species in the Tables will pass the test of microbiological risk. Human illness significantly and unambiguously restricts the number of species considered. Documented human illnesses, however, are relatively difficult to find. Such a lack of data alone should not exclude species from consideration for mandatory inspection. Sufficiency of market will further limit the number of species. However, if the species is produced, marketed, and consumed in relatively large quantities, as in the case of ratites, rabbit, pheasant, quail, and squab, the case for mandatory inspection is strengthened. Compatibility with inspection also narrows the field of potential species because establishments with grants of inspection are not always available near the locations where non-amenable species are raised or caught, and because some species present novel inspection problems due to their awkward physical conformation, e.g., ostriches. Finally, cost provides the final test to determine the manner in which scarce resources are used to improve public health. None of these criteria should be used alone as evidence in favor of or in opposition to expanding mandatory inspection to additional species. They should be used collectively to determine the appropriate course of action.

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Conclusion

In order to add to the species of animals required to be inspected by USDA using the criteria suggested in this paper, more information is needed. The Agency welcomes the input of the NACMPI on the approach of using these criteria and whether, in fact, they are adequate or whether other criteria are necessary.

Specifically, information is needed regarding the exposure of at-risk populations to human foods derived from exotic species. Information is also needed regarding the specific pathogens that are associated with exotic species and confirmed reports about foodborne illnesses associated with products of exotic species.

It is widely known that animal flesh products are potential sources for microbiological and zoonotic foodborne illnesses. Mandatory inspection of animal species provides a means of ensuring consumers receive safe products. It can be assumed that some number of consumers are exposed to greater public health risks from products derived from animals that are not under mandatory inspection or voluntary inspection. In order to alleviate public health risks in an effort to achieve a seamless Federal/State food safety inspection system, criteria can be developed and used to determine what additional species should be added to mandatory inspection.

Such criteria include whether the animal species is used as human food, whether the animal species is likely to present microbiological risks or cause human illnesses, and whether the animal species product is produced and consumed in a large enough volume to make exposure a public health concern (especially to at-risk populations). These factors need to be weighed against the compatibility of the inspection of the non-amenable species to current inspection procedures and practices, and the costs of including the additional species under the mandatory inspection program.

A more comprehensive analysis of the costs associated with adding to the list of amenable species also needs to be performed. These costs are not straightforward. Cost estimates must account for the different scenarios that may occur. For example, species being inspected by FSIS under voluntary inspection generate funds for the Agency. When these species fall under mandatory inspection, FSIS loses these funds and continues to spend the resources. Additionally, costs will not remain constant; when inspection becomes mandatory, the number of animals slaughtered increases and the number of establishments slaughtering and processing increase. Thus, the Agency’s costs increase, requiring additional appropriated funds or the re-direction of existing funds.

Further consideration and analyses are needed from State inspection programs regarding the effect of adding more species to mandatory inspection. If States performing exotic animal inspection do not have an "equal to" program, they must create one or the inspec-tion activity is absorbed by FSIS. States must consider how long it will take them to start an "equal to" program and what happens during that start-up period. These States would have to pass legislation, appropriate funds, and train personnel, among other things.