Inspection Program to
National Advisory Committee on Meat and Poultry Inspection
October 31-November 1, 2000, Public Meeting
Briefing Paper on Current Thinking
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
- the statutory and regulatory basis for mandatory and voluntary
- 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
- 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
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.
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
- 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
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
- 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
- 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)