[Federal Register Volume 65, Number 7 (Tuesday, January 11, 2000)]
[Rules and Regulations]
[Pages 1529-1537]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-589]
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Rules and Regulations
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Federal Register / Vol. 65, No. 7 / Tuesday, January 11, 2000 / Rules
and Regulations
[[Page 1529]]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 94
[Docket No. 97-079-2]
RIN 0579-AA91
Importation of Pork and Pork Products From Yucatan and Sonora,
Mexico
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the regulations concerning the importation of
animal products to relieve certain restrictions on the importation of
pork and pork products from the Mexican State of Yucatan. Because of
the existence of hog cholera in Mexico, we have required pork and pork
products from Yucatan to be heated or cured and dried to certain
specifications to be eligible for entry into the United States. This
rule establishes new conditions for the importation of fresh and
processed pork and pork products from Yucatan into the United States
and also provides for the movement of pork and pork products from
Yucatan through areas where hog cholera may exist in transit to the
United States. We are also amending the regulations that provide for
the importation of fresh pork from the Mexican State of Sonora to also
allow the importation of pork products from Sonora and to modify the
import conditions for Sonoran pork and pork products so that those
conditions parallel the import conditions for pork and pork products
from Yucatan. These amendments provide for the importation of pork
products from Sonora and for the in-transit movement of Sonoran pork
and pork products through areas where hog cholera may exist and make it
clear that pork and pork products from Sonora must be derived from
swine slaughtered at federally inspected slaughter plants.
EFFECTIVE DATE: February 10, 2000.
FOR FURTHER INFORMATION CONTACT: Dr. John Cougill, Senior Staff
Veterinarian, Products Program, National Center for Import and Export,
VS, APHIS, 4700 River Road Unit 40, Riverdale, MD 20737-1231; (301)
734-3399; or e-mail: john.w.cougill@usda.gov.
SUPPLEMENTARY INFORMATION:
Background
The Animal and Plant Health Inspection Service (APHIS) of the U.S.
Department of Agriculture (USDA) regulates the importation of animals
and animal products into the United States to guard against the
introduction of animal diseases not currently present or prevalent in
this country. The regulations pertaining to the importation of animals
and animal products are set forth in the Code of Federal Regulations
(CFR), title 9, chapter I, subchapter D (9 CFR parts 91 through 99).
The regulations in 9 CFR part 94 pertain to, among other things,
the importation of meat and other animal products into the United
States. Until the effective date of this rule, Sec. 94.20 allows fresh
(chilled or frozen) pork from Sonora, Mexico, to be imported if: The
pork is meat from swine that were born, raised, and slaughtered in
Sonora; the pork has not been in contact with pork from regions other
than those listed in Sec. 94.9(a) as regions where hog cholera is not
known to exist; and an authorized official of Mexico has certified on
the foreign meat inspection certificate (required by 9 CFR 327.4) that
the above conditions have been met.
On February 23, 1999, we published in the Federal Register (64 FR
8755-8761, Docket No. 97-079-1) a proposal to amend Sec. 94.20 to (1)
expand the importation of fresh pork to include any type of pork or
pork products from Sonora; (2) allow the importation, under certain
conditions, of pork and pork products from Yucatan, Mexico; and (3)
amend some of the provisions pertaining to pork from Sonora so that the
same import requirements apply to pork and pork products from both
Sonora and Yucatan, Mexico. We based our proposed rule on information
presented to APHIS by the Mexican Government in 1995 in a request to
recognize the Mexican State of Yucatan as free of hog cholera and on a
site visit that APHIS officials made to Yucatan in 1996 to verify that
Yucatan had the veterinary infrastructure, disease control programs,
diagnostic capabilities, and surveillance programs necessary to
diagnose and prevent an introduction of hog cholera. Following the site
visit, we performed a qualitative risk assessment on the importation of
pork and pork products from federally inspected slaughtering plants in
Yucatan. The qualitative risk assessment indicated that such
importations would present a negligible risk of introducing hog cholera
into the United States.
Based on the finding of negligible risk, we proposed to allow the
importation of pork and pork products from Yucatan, Mexico. However, we
proposed to allow these importations to occur only under certain
conditions (set forth below) to help prevent the possibility that pork
or pork products from swine raised in regions of Mexico other than
Yucatan or Sonora could be exported to the United States via Yucatan.
As stated above, we proposed to amend the import conditions for pork
from Sonora at Sec. 94.20 to provide the same import conditions for
pork and pork products from both Sonora and Yucatan. We wanted to
prevent the following possibilities: That swine from regions of Mexico
other than Sonora or Yucatan could be moved to Yucatan or Sonora for
slaughter, processing, and export to the United States; that pork or
pork products from other regions could be moved to Yucatan or Sonora
for export to the United States; or that, once leaving Yucatan or
Sonora, pork and pork products from Yucatan or Sonora could be
commingled with pork or pork products from other regions of Mexico in
transit to the United States. We stated our belief that the proposed
import conditions would provide a higher degree of safety against the
occurrence of any of these scenarios than the requirements then listed
in Sec. 94.20.
In the proposed rule, we set forth (1) our reasons for believing
that the importation, under certain conditions, of pork and pork
products from Yucatan can be accomplished safely; (2) our reasons for
proposing to amend the import conditions for pork from Sonora and to
allow the importation of pork products from Sonora; (3) the proposed
import conditions for pork and pork products from Yucatan and Sonora;
and
[[Page 1530]]
(4) our basis for the proposed import conditions. The proposed import
conditions follow:
1. The pork or pork product must be from swine that were born and
raised in Sonora or Yucatan and slaughtered in Sonora or Yucatan at a
federally inspected slaughter plant under the direct supervision of a
full-time salaried veterinarian of the Government of Mexico, and the
slaughter plant must be approved to export pork and pork products to
the United States in accordance with 9 CFR 327.2.
2. If processed in any manner, the pork or pork product must be
processed at a federally inspected processing plant located in either
Sonora or Yucatan under the direct supervision of a full-time salaried
veterinarian of the Government of Mexico.
3. The pork or pork product must not have been in contact with pork
or pork products from any State in Mexico other than Sonora or Yucatan
or from any other region not listed in Sec. 94.9(a) as a region where
hog cholera is not known to exist.
4. The foreign meat inspection certificate for the pork or pork
product (required by 9 CFR 327.4) must be signed by a full-time
salaried veterinarian of the Government of Mexico. The certificate must
include statements that certify the above conditions have been met. The
certificate must also show the seal number on the shipping container if
a seal is required (see below).
5. In addition, if the pork or pork product is going to transit any
State in Mexico other than Sonora or Yucatan or any other region not
listed in Sec. 94.9(a) as a region where hog cholera is not known to
exist, a full-time salaried veterinarian of the Government of Mexico
must apply serially numbered seals to the containers carrying the pork
or pork products at the federally inspected slaughter or processing
plant located in Sonora or Yucatan, and the seal numbers must be
recorded on the foreign meat inspection certificate.
6. Prior to its arrival in the United States, the shipment of pork
or pork products must not have been in any State in Mexico other than
Sonora or Yucatan or in any other region not listed in Sec. 94.9(a)
unless the pork or pork products have remained under seal until arrival
at the U.S. port and either (1) the numbers on the seals match the
numbers on the foreign meat inspection certificate or (2) if the
numbers on the seals do not match the numbers on the foreign meat
inspection certificate, an APHIS representative at the port of arrival
is satisfied that the pork or pork products were not contaminated
during movement to the United States.
We solicited comments concerning our proposal for 60 days ending
April 26, 1999. We received four comments by that date. They were from
a State government, an association representing veterinarians, and
associations representing the U.S. swine industry and the Yucatan swine
industry. Two commenters supported the proposed rule; one commenter
asked numerous questions about many aspects of the proposed rule but
expressed support for the proposed import conditions; and one commenter
expressed many concerns about the information in the background section
of the proposed rule without specifically expressing support or
opposition to the proposed rulemaking action. Some of the comments were
outside the scope of this rulemaking action. Our responses to the
comments pertinent to the proposed rule are discussed below by topic.
Veterinary Infrastructure
Two commenters asked general questions about the veterinary
infrastructure in Yucatan, including whether Mexican and Yucatan laws,
regulations, and policies support the maintenance of surveillance for
hog cholera and whether Mexican animal health officials have the
necessary resources to restrict movements of swine and swine products
from Mexican States where hog cholera may exist. One commenter asked
about Yucatan producer awareness of hog cholera, producer and
practitioner reporting responsibilities with regard to suspect cases,
and the continued level of suspect hog cholera investigations in
Yucatan. The commenter further asked about the testing requirements
administered by Yucatan animal health officials for new breeding stock
introduced from other Mexican States. Finally, the commenter asked
whether a feral swine population exists in Yucatan and, if so, whether
it has been tested for hog cholera.
We believe that the Mexican veterinary infrastructure has the
ability and resources to restrict movements into Yucatan of swine and
swine products from areas of greater risk for hog cholera. When we
conducted the 1996 site visit, we thoroughly studied Yucatan's
veterinary infrastructure. In addition to learning about the individual
responsibilities of and relationship between the various levels of
government overseeing animal health activities in Mexico, we reviewed
activities to prevent the introduction of hog cholera into Yucatan.
Mexican animal health officials exercise tight movement controls on all
land, air, and maritime traffic in Yucatan. Detailed descriptions of
the veterinary infrastructure in Mexico, particularly in Yucatan, and
these movement controls may be found in the site visit report as well
as in the qualitative risk assessment. For copies of these documents,
contact the person listed under FOR FURTHER INFORMATION CONTACT.
Through APHIS employees stationed in Mexico and at our headquarters
in Riverdale, MD, we remain in constant contact with Mexican animal
health officials. We continue to have confidence in their abilities to
prevent the introduction of hog cholera into the Yucatan swine
population and, in the unlikely event an outbreak would occur, to
identify and contain it appropriately. In regard to producer awareness
of hog cholera, Yucatan swine producers could have greater awareness of
hog cholera than some U.S. swine producers because of more recent
experience with the disease. While the last case of hog cholera in
Yucatan occurred in 1982, hog cholera was eradicated from the United
States in the 1970's. In addition, Mexican animal health officials have
erected signs on major roadways in Yucatan proclaiming the State as
free of hog cholera and stating restrictions on the movement into
Yucatan of commodities that could reintroduce hog cholera into the
State. Suspect cases of hog cholera infection are reported and
investigated in Yucatan in a similar manner as in the United States.
The Yucatan swine industry imports breeding stock from the United
States, Canada, and Sonora. Swine movements into Yucatan are not
allowed from any other area in Mexico. We are unaware of the existence
of any feral swine population in Yucatan.
Laboratory Capabilities
A commenter asked whether positive controls or periodic check tests
are used in Mexican animal health laboratories to confirm the quality
of their testing. Two commenters asked whether Mexican laboratory
officials had acted upon recommendations from the site visit report
regarding check-testing by the APHIS National Veterinary Services
Laboratories (NVSL) in Ames, IA, of the diagnostic results obtained for
blood samples tested for hog cholera at Mexican animal health
laboratories.
We have confidence in the diagnostic capabilities of Mexican animal
health laboratories. As stated in the proposed rule, these laboratories
meet the standards of the Office International des Epizooties. In
addition, in 1997 we sent ``blind'' samples twice to the regional
[[Page 1531]]
laboratory in Merida, Yucatan, and the central laboratory in Mexico
City. These laboratories administered the diagnostic tests with the
proper controls, and the results reported agreed with the findings
reached by NVSL.
Traceback Capabilities
A commenter asked about procedures in place by APHIS and the
Mexican Government to trace shipments of pork or pork products that
might be contaminated as a result of the identification of an animal or
herd in Yucatan as suspect or positive for hog cholera.
If Mexican animal health officials were to find an animal that was
positive for hog cholera, they would report the case immediately to
APHIS officials. We would immediately prohibit the importation of pork
and pork products from Yucatan. As in any other similar situation in
which a foreign region reports an outbreak of an animal disease of
concern to us, we would work with USDA's Food Safety and Inspection
Service to try to trace any potentially contaminated products that had
been imported from that region.
Commercial Production
A commenter expressed concern regarding the biosecurity measures
practiced by communal production facilities in Yucatan (small, shared
herds of 15 to 40 sows). The commenter was concerned that these
facilities are considered part of the commercial production system in
Yucatan. (As such, according to the proposed rule, pork and pork
products from swine from these facilities could be eligible for export
to the United States if the swine were slaughtered in a federally
inspected slaughter plant.) The commenter further asked how Yucatan
producers know if their herds are ``export-eligible'' and how the
federally inspected plants know upon the arrival of hogs whether they
are from export-eligible herds.
The commenter supported the proposed change to the import
conditions for pork from Sonora that would require pork and pork
products from Sonora to be derived from swine slaughtered at federally
inspected slaughter plants. The commenter asked whether there has been
any cause for concern about the exportation to the United States of
Sonoran pork from Sonoran slaughter plants that are not federally
inspected.
The commercial swine industry in both Sonora and Yucatan is
concentrated among relatively few producers. In Yucatan, as of 1996, 3
producers owned 65 percent of the 65,000 sows in the commercial
production facilities. As a good business practice, the federally
inspected slaughtering facilities in Yucatan and Sonora accept swine
only from the large, commercial production facilities in those States.
By doing so, the slaughtering facilities have assurance regarding the
health status of the swine they accept for slaughter. The biosecurity
measures practiced at communal swine production facilities in Yucatan
do not meet the level of biosecurity measures practiced in the large,
integrated commercial production facilities in Yucatan. Mexican animal
health officials have confirmed that the federally inspected
slaughtering establishments in Yucatan do not accept swine from
communal production facilities; swine from these facilities are
processed in municipal plants for local use only. Moreover, under
Mexican federal regulations, only commercially raised swine may be
slaughtered for export to the United States. For that reason, we do not
believe that pork has been exported to the United States from other
than federally inspected slaughtering plants in Sonora.
Surveillance Procedures
We received numerous comments regarding activities by Mexican
animal health officials to determine whether hog cholera exists in the
Yucatan swine population. We have divided these comments into three
groups, which are discussed in separate sections below as follows:
Comments pertaining to procedures for determining the extent of the
Yucatan swine population are under the heading Census Results; comments
pertaining to blood sampling of the Yucatan swine population for hog
cholera are under the heading Serologic Surveys; and comments
pertaining to the methodology used to determine the number of blood
samples that must be taken from the Yucatan swine population to obtain
a reasonable degree of confidence that, if hog cholera existed in the
population, it would be detected are under the heading Sampling
Methodology. Following a description of all of these comments is our
discussion of them.
Census Results
A commenter asked how the 1993 census of Yucatan swine herds was
taken, especially in regard to ``backyard'' farms. The commenter
further asked how many backyard farms were in existence when serologic
surveys of commercial and backyard farms were performed in 1995.
Another commenter asked about the results of the 1996 census of
backyard swine and whether the serologic surveillance of the backyard
swine population was modified as a result of that census.
Serologic Surveys
A commenter expressed the opinion that a surveillance survey
conducted for a period of 3 months might not truly reflect the disease
status of any region. (The commenter was referring to a serologic
survey of Yucatan swine herds conducted from January through March
1995.) The commenter asked about the results of an APHIS evaluation of
the methodology used by Mexican animal health officials to collect
serologic samples in Yucatan and whether APHIS made recommendations
regarding the methodology used.
Two commenters asked whether a serologic survey was conducted in
1996 and, if so, about the results. One commenter asked upon what
census the 1996 serologic survey was based. The commenter further asked
about the level of monitoring of the backyard herds that APHIS or
Mexican animal health officials consider necessary for ensuring the hog
cholera status of these herds.
Sampling Methodology
A commenter asked how the prevalence figure of 0.2 percent was
arrived at for use in the sampling methodology and stated that, if a
lower prevalence were used, the number of samples required for the
survey would increase drastically. The commenter further stated that
the site visit report made a recommendation regarding sampling
methodology but that no indication has been given that the
recommendation was implemented and what the results were. Another
commenter asked about the conclusions of the review of the sampling
methodology in backyard pigs and whether this review resulted in
modifications to the current sampling to increase the likelihood of
detecting disease. The commenter further asked whether experience with
hog cholera in backyard herds provided any indication of the expected
ranges of seroprevalence in positive herds.
In taking a census of the Yucatan swine population in 1993 and
again in 1996, Mexican animal health officials used standard methods to
gather data, including visiting townships in Yucatan to interview swine
producers. The data from the 1993 census was used in conducting the
serologic survey in 1995. While we do not know the total number of
backyard swine farms that existed in Yucatan in 1995, the 1993 census
reported the number of swine in Yucatan backyard farms as 114,254. We
do not expect Mexican animal health
[[Page 1532]]
officials to conduct a yearly census of Yucatan swine, nor do we
believe that such a census is necessary. Mexican officials have
collected swine census data for Yucatan, and, as a result of ongoing
serologic sampling by animal health technicians, that data has been
updated from year to year.
In the serologic survey conducted in 1995, samples were taken from
every commercial farm, with a total of 2,459 samples taken from such
farms. Samples were also taken from backyard farms in proportion to
each municipality's swine population based on the 1993 census. Mexican
animal health officials used the sampling methodology just described
again in 1996 and 1997 to sample commercial and backyard farms. In
every year's survey, all samples have been negative for hog cholera.
The following table presents the number of serum samples collected and
evaluated with negative results at Yucatan swine facilities from 1995
to 1997:
------------------------------------------------------------------------
Type of operation 1995 1996 1997 Total
------------------------------------------------------------------------
Commercial Farms............ 2,459 2,526 2,502 7,487
Backyard Farms.............. 429 1,185 1,743 3,357
Community Slaughterhouses... ......... 641 660 1,301
Federally Inspected ......... 1,378 1,360 2,738
Slaughterhouses............
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Total................... 2,888 5,730 6,265 14,883
------------------------------------------------------------------------
The seroprevalence figure of 0.2 percent was established by Mexican
animal health officials to determine the sampling strategy. It is true
that a lower prevalence figure would increase the number of samples to
be taken. However, if hog cholera were endemic in Yucatan, the
prevalence figure would far exceed 0.2 percent. Based on our own
judgment and experience with hog cholera eradication in the United
States, if hog cholera existed in Yucatan, the seroprevalence would be
higher than 0.2 percent because Yucatan's swine population is
immunologically naive as a result of being unvaccinated for several
years. Moreover, we do not believe that hog cholera could survive in
the backyard herds in Yucatan without passing into the commercial herds
and quickly being detected.
Currently, serologic surveys are being conducted as follows: Every
year, samples are taken from all commercial herds and from 300 randomly
selected backyard herds. For the backyard swine population in Yucatan,
300 herds is the sample size needed to detect hog cholera with a 95
percent confidence level if the disease exists at a herd prevalence of
1 percent or higher. The census results do not change this number. The
census serves to give a complete listing of all of the farms that have
an equal chance of being sampled. At the backyard farms in Yucatan, up
to five samples are taken per herd.
The same sampling procedures are being conducted in Campeche and
Quintana Roo (the two Mexican States that border Yucatan) as in
Yucatan. Every year, Mexican animal health officials take blood samples
from 300 randomly selected backyard herds (up to 5 samples per herd) in
each of those 2 States. In addition, Mexican animal health officials
are sampling an additional 600 backyard herds in Campeche along the
State border with Tabasco. Most of the herds being sampled have fewer
than five animals.
In the site visit report, we stated, ``Pending further analysis of
the data, recommendations may be made to modify their current sampling
methodology to increase the likelihood of detecting disease.'' We have
recommended increased sampling of backyard farms in high-risk areas,
such as along the borders with other States, and this recommendation
has been followed. Based on available data, we do not believe that a
precise level of monitoring of backyard herds in Yucatan on a periodic
basis can be determined. Such a determination would require such
additional information as an evaluation of the veterinary
infrastructure and disease status of Yucatan's neighboring States.
However, we have confidence that the current annual sampling of 300
backyard herds as described previously would reveal any hog cholera
virus present in those herds.
We would like to emphasize that serologic surveillance of the
Yucatan swine population was only one component of our proposal to
allow the importation under certain conditions of pork and pork
products from Yucatan. Many other factors, which are listed in the
proposed rule and the qualitative risk assessment, were considered and
continue to be important. As examples, hog cholera has not been
diagnosed within Yucatan for more than 15 years and is not known to
exist in any adjacent State, and Yucatan has prohibited vaccination of
swine for hog cholera for more than 5years. As a result, the Yucatan
swine population has become immunologically naive, so any introduction
of hog cholera virus would spread quickly, easing detection. In
considering many factors altogether, including the fact that serologic
surveillance has been maintained for several years now with no findings
of animals positive for hog cholera, we believe that pork and pork
products from Yucatan can be imported into the United States without
putting the health of the U.S. swine population at risk.
Risk Assessment
A commenter questioned the statement in the risk assessment that
the importation of pork and pork products from Yucatan would present a
negligible risk of introducing hog cholera. The commenter asked how the
risk of introducing hog cholera from pork and pork products is
negligible if the risk of hog cholera introduction from live swine is
low.
The site visit report characterizes Yucatan as an area of low risk
for hog cholera based on a high-medium-low paradigm. However, APHIS
policy on the importation of animals and animal products states that
import decisions on animals and animal products will not be based
solely on the characterization or status of the exporting region but
rather on a risk assessment addressing the risks presented by a
specific commodity from a specific region. The risk assessment must
consider information about the animal health situation existing in the
region and the probability that the commodity would transmit and
establish disease in the United States.
Based on the observations of the site visit team and analysis of
information submitted by Mexico, we performed a qualitative risk
assessment of the importation of pork and pork products from Yucatan
into the United States. Taking into account all of the available
evidence concerning hog cholera virus and Yucatan, APHIS found that the
probability that Yucatan swine are infected with undetected hog cholera
virus is small. The pathway for hog cholera introduction into the U.S.
swine
[[Page 1533]]
population via contaminated imported pork or pork products would be via
feeding uncooked or improperly cooked pork or pork products to pigs in
this country. Pork is known to be capable of transmitting hog cholera.
However, pork is a high-value commodity intended for human consumption,
and U.S. consumers routinely cook pork at a temperature sufficient to
kill hog cholera virus. Furthermore, before human food waste such as
pork can legally be fed to swine, the waste must be cooked again.
Therefore, even if a small quantity of pork contaminated with hog
cholera virus were to be imported into the United States, the
probability that it would be fed uncooked to pigs is extremely small.
For these reasons and the many others discussed in this document, the
proposed rule, and the qualitative risk assessment, we find the
combined evidence sufficient to conclude that imported pork and pork
products from Yucatan, even if containing a low level of hog cholera
virus, are unlikely to cause an outbreak of hog cholera in the United
States.
Request for New Site Visit
A commenter requested that APHIS conduct another site visit to the
Yucatan and include veterinary practitioners and representatives of the
U.S. swine industry.
We believe that the data gathered from our 1996 site visit is still
valid and supports our proposal to allow the importation of pork and
pork products from Yucatan under certain conditions, and we do not
believe that an additional site visit is necessary to gather additional
data. We believe that, if the data has changed in any way, it has
likely changed to provide stronger support for the proposed rule. Since
our site visit in 1996, more time has passed since the last outbreak of
hog cholera in Yucatan and since vaccination for hog cholera was
discontinued there. In addition, since our site visit, the States
bordering Yucatan have been declared free of hog cholera by the Mexican
Government, so the threat of possible introduction of hog cholera into
Yucatan from adjacent regions has been further reduced. Moreover, as
stated previously, APHIS employees permanently stationed in Mexico
maintain constant contact with Mexican agricultural officials. We have
confidence in their abilities and efforts to eradicate hog cholera and
prevent reintroduction into areas that have been declared free of the
disease.
Other Diseases
A commenter asked whether APHIS has conducted a review of diseases
that might be present in Mexico and are not considered to be present in
the United States other than ``List A'' diseases. The commenter was
particularly concerned about blue eye disease, which the commenter
states has been reported in many States in Central Mexico and has been
identified in hogs in Yucatan slaughterhouses. The commenter wanted to
know whether APHIS has considered the potential for transmission of
blue eye virus in pork products from Yucatan and Sonora and what type
of surveillance program is in place for this disease.
This rule pertains exclusively to the importation of pork and pork
products--not live swine--from Yucatan and Sonora. Other than hog
cholera, which is known to be transmitted by fresh pork, no other swine
diseases that can be transmitted by pork exist in Mexico. Therefore,
our risk assessment pertained exclusively to hog cholera. Mexican
animal health officials report that blue eye disease has never been
confirmed in Yucatan. In addition, no evidence exists to indicate that
the agent that causes blue eye disease is transmitted by fresh pork.
Proposed Conditions
A commenter asked how APHIS or Mexican animal health officials
would determine that pork and pork products from Yucatan or Sonora,
Mexico, have not been in contact with pork or pork products from any
State in Mexico other than Yucatan or Sonora or from any other region
not listed in Sec. 94.9(a) as a region where hog cholera is not known
to exist.
The commenter asked another question about the proposed regulation
regarding seals on the containers of pork and pork products from
Yucatan and Sonora. The commenter asked how, in situations where, upon
arrival of the pork or pork product in the United States, the numbers
on the seals do not match the numbers on the foreign meat inspection
certificate, would the APHIS representative at the port of arrival be
certain that the shipment contains the original product and has not
been subject to contamination.
The commenter also asked about what procedures are in place to
ensure that only products from swine born and raised in Sonora or
Yucatan will be exported to the United States since Yucatan animal
health officials allow the movement into Yucatan of pork products from
other Mexican States. Another commenter stated that, although the
intent of allowing only pork or pork products to be imported from
federally inspected plants in Yucatan is to eliminate the risk of
importing products derived from swine raised in backyard herds, nothing
in the rule prohibits a federally inspected plant in Yucatan from
accepting such swine.
The Mexican Government is ultimately responsible for ensuring that
our import conditions are followed. Mexican animal health officials are
responsible for certifying that pork or pork products from Yucatan and
Sonora have not been in contact with pork or pork products from regions
where hog cholera could possibly exist and that only pork or pork
products from swine born and raised in Yucatan or Sonora are exported
to the United States. When importations of pork and pork products from
Yucatan commence, our Mexican counterparts will have to certify that
these conditions have been met.
Regulating the activities of Mexican slaughtering facilities would
not be within our purview, so we would not attempt to prohibit
federally inspected slaughtering facilities in Yucatan or Sonora from
accepting swine from backyard farms. However, we also believe that such
a prohibition is unnecessary. As stated previously, Mexican animal
health officials have confirmed that the federally inspected
slaughtering facilities in Yucatan and Sonora do not accept swine from
backyard farms. To ensure that they are receiving high-quality hogs,
the federally inspected slaughtering facilities in Yucatan and Sonora
accept swine only from the large, commercial production facilities. The
owners of the slaughtering facilities know that, to be able to ship
pork and pork products to the United States, the facilities must not
ship any pork or products derived from pigs with an unknown veterinary
health status. In the unlikely event federally inspected slaughtering
facilities in Yucatan and Sonora start accepting swine from backyard
farms, we could take any necessary action to prevent the importation of
pork or pork products derived from such swine. Through publication of
an interim rule, we could immediately prohibit such shipments.
Our requirements regarding the seals are the same as our
requirements for seals on animal products from many foreign regions.
Any manipulation of the seals applied to containers of pork or pork
products imported from Yucatan or Sonora and application of new seals
must be performed under the direct supervision of a Mexican Government
official, and an explanation must accompany the product to the U.S.
port
[[Page 1534]]
of arrival. If containers of pork or pork products from Yucatan or
Sonora arrive at a U.S. port with broken seals and insufficient
documentation, we would require that the importer provide the proper
documentation within 48 hours or the shipment would be denied entry. In
accordance with Sec. 94.7, animal products denied entry into the United
States must be disposed of or exported within a prescribed period of
time.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, without
change.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. The rule
has been determined to be significant for the purposes of Executive
Order 12866 and, therefore, has been reviewed by the Office of
Management and Budget. A summary of the analyses required by Executive
Order 12866 and the Regulatory Flexibility Act are set forth below.
Copies of the entire analyses may be obtained by contacting the person
listed under FOR FURTHER INFORMATION CONTACT.
In accordance with 21 U.S.C. 111, the Secretary of Agriculture is
authorized to promulgate regulations to prevent the introduction or
dissemination of any contagious, infectious, or communicable disease of
animals from a foreign country into the United States. This rule amends
the regulations pertaining to the importation of animal products by
establishing new, less restrictive, conditions for the importation of
fresh and processed pork and pork products from Yucatan, Mexico, into
the United States. The rule also provides for the movement of pork and
pork products from Yucatan through areas where hog cholera may exist
while in transit to the United States. The rule also amends the
regulations regarding the importation of fresh pork from Sonora,
Mexico, to allow the importation of pork products from Sonora and to
modify the import conditions for Sonoran pork and pork products so that
those conditions parallel the import conditions for pork and pork
products from Yucatan. These amendments provide for the importation of
pork products from Sonora and for the in-transit movement of Sonoran
pork and pork products through areas where hog cholera may exist and
make it clear that pork and pork products from Sonora must be derived
from swine slaughtered at federally inspected slaughter plants.
The disease of concern regarding the importation of pork and pork
products from Yucatan is hog cholera. The segment of the U.S. swine
industry most likely to be first exposed to hog cholera from imported
pork products is the segment that uses human food waste as a feed
source. Because the hog cholera virus remains infective in pork
products for a long time unless the products are cooked properly, the
disease can be transmitted to swine fed discarded, uncooked or
insufficiently cooked pork. The Swine Health Protection Act requires
that waste-feeding swine operations heat the waste according to
prescribed procedures that kill such organisms before feeding the waste
to the swine.
A qualitative risk assessment prepared by APHIS indicates that the
expected costs of disease introduction are likely to be zero, as the
proposed imports pose a low probability of causing a hog cholera
outbreak in the United States. APHIS also conducted a quantitative risk
assessment based only on serologic survey data of commercial swine
operations in Yucatan. Due to modeling constraints, the quantitative
risk assessment did not include some of the information most pertinent
to risk evaluation, such as the fact that an outbreak of hog cholera
has not occurred in Yucatan since 1982. However, the quantitative model
is useful in that it provides an upper limit on the estimated
probability of a hog cholera outbreak and acknowledges that the actual
risk is likely to be lower. Expected costs associated with the
anticipated trade in pork and pork products from Yucatan are calculated
by multiplying the estimates from the quantitative model of the
likelihood of an outbreak and the estimated economic consequences of an
outbreak.
In accordance with Executive Order 12866, APHIS has compared the
benefits of the increased trade to the expected costs resulting from a
disease outbreak. The benefits are calculated as the net change in
consumer and producer surplus that results from the estimated volume of
trade.
Yucatan generates 7-8 percent of Mexico's pork production and is a
net exporter of pork, with 65 percent of the pork produced in the State
going to the tourist centers in the neighboring State of Quintana Roo,
population centers in and around Mexico City, and Japan. Pork intended
for export is produced at the State's only federally inspected
slaughter facility, which accepts swine only from commercial producers.
Commercial swine production in Yucatan is concentrated among
approximately 200 producers, who collectively own about 65,000 sows
(1996 data). Three producers alone own 65 percent of these sows, all of
which are housed in highly integrated operations similar to those found
in the United States. At full capacity, the federally inspected
slaughtering facility in Yucatan can slaughter up to 1,000 head per
day, with a maximum annual production of 10,000 metric tons of pork.
Based on existing Yucatan hog production and slaughter capacity, we
believe that Yucatan producers could export between 200 and 10,000
metric tons of fresh and frozen pork to the United States per year. The
high-volume scenario is based on the maximum output of the federally
inspected slaughter facility and assumes that all 10,000 metric tons
produced there would be shipped to the United States. Because this
scenario is highly unlikely, we also evaluated more realistic scenarios
of 1,000 and 200 metric tons. The most likely amount of pork imported
into the United States from Yucatan would probably be between these two
amounts. Therefore, the regulatory impact analysis summarized here
examines the potential economic impact of such imports under low-(200
metric tons per year), medium-(1,000 metric tons per year), and
high-(10,000 metric tons per year) volume scenarios.
Results of computer simulation iterations for the low-volume
simulations indicate positive net benefits in 90 percent of the
iterations run. Results of the medium-volume simulations indicate
positive net benefits in 85 percent of the iterations run. Results from
the high-volume scenario indicate positive net benefits in 75 percent
of the iterations run. In the absence of disease (when likelihood
estimates are zero), the annual
net benefits of trade for the low-, medium-, and high-volume scenarios
are estimated, in 1997 dollars, at $6,478, $32,429, and $329,011,
respectively. Therefore, based on these calculations, positive net
benefits would result from any of the scenarios. The details are
contained in the economic impact analysis, as indicated previously.
In conclusion, we believe that the likelihood of hog cholera
introduction and its associated biological and economic consequences is
sufficiently low as to warrant allowing the importation of pork and
pork products from Yucatan. Assuming that, among other things, Yucatan
pork is a perfect substitute for domestic pork, we estimate that the
net benefits of Yucatan pork imports will be positive. Importations of
Yucatan pork will cause U.S. farm gate prices to decrease marginally,
benefitting U.S. consumers.
[[Page 1535]]
Final Regulatory Flexibility Analysis
The Regulatory Flexibility Act requires Federal agencies to analyze
possible effects of their regulations on small businesses and to use
flexibility to provide relief when regulations could create economic
disparities between entities of different sizes. According to the Small
Business Administration (SBA), regulations create economic disparities
based on size when the regulations have a ``significant economic impact
on a substantial number of small entities.''
Over the past several decades, the U.S. pork industry has
experienced enormous structural change, which mirrors the overall trend
toward ``concentration'' in U.S. agriculture. The shift toward fewer
but larger farms has been dramatic in the hog sector. According to the
1997 Census of Agriculture, from 1992 to 1997, the number of farms
selling hogs decreased by almost 46 percent (from 188,000 to 102,000),
while the value of hogs and pigs sold increased by 37 percent (from $10
billion to $13.8 billion). The pork processing industry is also
characterized by a decreasing number of companies operating
increasingly large, capital-intensive processing and packing plants
that are dependent on high volumes of raw product and that begin to
realize economies of size at about 4 million hogs per year.
In 1994, about 2,000 swine producers were licensed as waste-feeding
establishments in the continental United States, and this number has
not changed greatly since then. The majority of these premises were
located in Texas (871), Florida (309), Arkansas (248), and North
Carolina (178). Waste-feeding operations are predominantly small. Based
on a 1994 APHIS survey, the median number of swine per waste-feeding
premises in the 48 conterminous States was 34 (average of 97). Only 10
of the premises had more than 1,000 swine.
The potential economic effects of the importation of pork and pork
products from Yucatan, Mexico, are dependent on a number of factors,
such as where the products would be consumed in the United States.
While it is currently unknown exactly how Yucatan pork would enter U.S.
marketing and distribution channels and where it would ultimately be
consumed, we believe that the pork would likely be shipped by ocean
vessel from Progreso, Yucatan, to a U.S. Gulf Coast port, most likely
in Texas or Florida, perhaps in Louisiana. If Yucatan pork is purchased
by a local retail chain or wholesaler in those States, the pork would
likely be consumed locally. If purchased by a national wholesaler,
Yucatan pork could be consumed anywhere in the United States. For the
purposes of this analysis, we examined both the possibility that
Yucatan pork would be consumed locally in selected Gulf Coast States
and also the possibility that it would enter national distribution
channels.
The SBA defines small hog farms (Standard Industrial Code 0213) as
those earning less than $500,000 in annual receipts. Industry experts
suggest that only those hog operations with inventories in excess of
2,000 animals would earn $500,000 or more in sales annually. According
to Census of Agriculture data, 6.5 percent of U.S. hog and pig
operations held inventories in excess of 2,000 animals in 1997, so by
SBA standards, 93.5 percent of all U.S. hog farms are small entities.
By these same criteria, more than 99 percent of hog farms in Texas,
Louisiana, and Florida are small entities. The average U.S. small hog
farm sold 560 head of stock and reported sales of $58,531 in 1997. In
Texas, Florida, and Louisiana, small hog farmers sold substantially
fewer animals (77 head per farm) and earned substantially less in sales
($7,413 annually).
In 1997, according to the Census of Agriculture, 87,820 small hog
farms were in operation nationwide; 4,700 of these were located in the
Gulf Coast States of Texas, Florida, and Louisiana. Whether we consider
the United States as a whole or just selected Gulf Coast States, the
overwhelming majority of hog farms are small entities, so it is
reasonable to conclude that a substantial number of small entities
could be affected by this rule.
Economic Effect on Small Entities
While no general rule sets threshold or trigger levels for
``significant economic impact,'' it has been suggested that an economic
effect that equals a small business' profit margin--5 to 10 percent of
annual sales--could be considered significant.
We used estimated changes in producer surplus together with the
1997 Census of Agriculture data on hog inventories and hog sales to
develop very rough estimates of the potential economic effects of the
rule on small hog farmers across the United States and in selected Gulf
Coast States. To do this, we assumed that losses in producer surplus
would be shared equally among all hog farms in the geographic area
under consideration (either the entire United States or selected Gulf
Coast States). We then compared per-farm changes in producer surplus
with small farms' annual sales to determine whether the economic
effects approach the 5-10 percent threshold.
If Yucatan pork enters national distribution channels and,
therefore, economic effects are shared by all U.S. producers, no
significant economic effect on small entities would occur regardless of
the volume (low, medium, or high) of imports assumed. Producer surplus
losses per U.S. hog farm would range from $0.63 to $31.61 per year, and
these amounts are substantially less than 1 percent of the typical
small hog farmer's annual sales ($58,531) in every scenario.
If, under the high-volume scenario, the maximum 10,000 metric tons
are imported annually from the Yucatan and consumed locally in
Louisiana, Texas, and Florida, the imports could result in significant
economic effects on small pork producers in those States. In this case,
a subset of small hog farmers with considerably fewer head per farm and
considerably less in annual revenues than the average U.S. small hog
farm would face the most significant economic effects of an increase in
imports. The producer surplus losses per small hog farm in those States
would range from $12.02 to $600.58. The larger amount is equivalent to
8.1 percent of the annual sales of the typical Gulf Coast small hog
farmer and, therefore, could be considered a significant economic
effect.
In conclusion, the rule could affect a substantial number of small
hog farms because almost all hog farms meet the SBA size criteria for
small entity. However, it is unclear whether the rule will have a
significant economic effect on small hog farms. The latter issue
depends on how much Yucatan pork is imported and where it is consumed.
Under the most extreme assumptions (highest volume imports and limited
geographic area affected), small hog producers in selected Gulf Coast
States could experience losses in producer surplus equaling
approximately 8 percent of annual sales. Such losses would meet
``significant economic impact'' criteria. Under the most likely import
volume scenario (1,000 metric tons per year), the rule will not have a
significant economic effect on small hog farmers either nationwide or
in selected Gulf Coast States.
Alternatives Considered
In developing this rule, we considered either (1) making no changes
to the existing requirements for the importation of fresh and processed
pork and pork products from Yucatan and Sonora, Mexico, (2) allowing
the importation of pork and pork products
[[Page 1536]]
from Yucatan and Sonora under conditions different from those set forth
in this document, or (3) allowing the importation of pork and pork
products from Yucatan and Sonora under the conditions set forth in this
document.
We rejected the first alternative because it would continue to
restrict the importation of pork and pork products from Yucatan under
the same conditions that apply to the remainder of Mexico. Because we
have determined that pork and pork products can be imported under
specified conditions from Yucatan and Sonora with negligible hog
cholera risk, taking no action would not be scientifically defensible
and would be contrary to trade agreements entered into by the United
States. We also rejected the second alternative, which would allow the
importation of pork and pork products from Yucatan and Sonora under
conditions other than those established by this rule. In developing the
criteria for the importation of such pork and pork products, we
determined that conditions less stringent than those set forth would
present a risk of the introduction of hog cholera into the United
States via pork or pork products from regions of Mexico other than
Sonora or Yucatan. We further concluded that more stringent conditions
would be unnecessarily restrictive. We consider the conditions set
forth by this rule to be both effective and necessary in ensuring that
the risk of hog cholera introduction via pork and pork product imports
from Yucatan and Sonora remains at a negligible level.
Executive Order 12988
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) Preempts all State and local laws
and regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
National Environmental Policy Act
An environmental assessment and finding of no significant impact
have been prepared for this rule. The assessment provides a basis for
the conclusion that the importation of pork and pork products from
Sonora and Yucatan, Mexico, under the conditions specified in this rule
will not present a risk of introducing or disseminating hog cholera
disease agents into the United States and will not have a significant
impact on the quality of the human environment. Based on the finding of
no significant impact, the Administrator of the Animal and Plant Health
Inspection Service has determined that an environmental impact
statement need not be prepared.
The environmental assessment and finding of no significant impact
were prepared in accordance with: (1) The National Environmental Policy
Act of 1969, as amended (NEPA) (42 U.S.C. 4321 et seq.), (2)
regulations of the Council on Environmental Quality for implementing
the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA
regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA
Implementing Procedures (7 CFR part 372).
Copies of the environmental assessment and finding of no
significant impact are available for public inspection at USDA, room
1141, South Building, 14th Street and Independence Avenue, SW.,
Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday,
except holidays. Persons wishing to inspect copies are requested to
call ahead on (202) 690-2817 to facilitate entry into the reading room.
In addition, copies may be obtained by writing to the individual listed
under FOR FURTHER INFORMATION CONTACT.
Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.), the information collection or recordkeeping requirements
included in this rule have been approved by the Office of Management
and Budget (OMB) under OMB control number 0579-0138.
List of Subjects in 9 CFR Part 94
Animal diseases, Imports, Livestock, Meat and meat products, Milk,
Poultry and poultry products, Reporting and recordkeeping requirements.
Accordingly, we are amending 9 CFR part 94 as follows:
PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, FOWL PEST (FOWL
PLAGUE), EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, HOG
CHOLERA, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND
RESTRICTED IMPORTATIONS
1. The authority citation for part 94 continues to read as follows:
Authority: 7 U.S.C. 147a, 150ee, 161, 162, and 450; 19 U.S.C.
1306; 21 U.S.C. 111, 114a, 134a, 134b, 134c, 134f, 136, and 136a; 31
U.S.C. 9701; 42 U.S.C. 4331 and 4332; 7 CFR 2.22, 2.80, and
371.2(d).
2. Section 94.20 is revised to read as follows:
Sec. 94.20 Importation of pork and pork products from Sonora and
Yucatan, Mexico.
Notwithstanding any other provisions of this part, pork and pork
products from the States of Sonora and Yucatan, Mexico, may be imported
into the United States under the following conditions:
(a) The pork or pork product is from swine that were born and
raised in Sonora or Yucatan and slaughtered in Sonora or Yucatan at a
federally inspected slaughter plant that is under the direct
supervision of a full-time salaried veterinarian of the Government of
Mexico and that is approved to export pork products to the United
States in accordance with Sec. 327.2 of this title.
(b) If processed, the pork or pork product was processed in either
Sonora or Yucatan in a federally inspected processing plant that is
under the direct supervision of a full-time salaried veterinarian of
the Government of Mexico.
(c) The pork or pork product has not been in contact with pork or
pork products from any State in Mexico other than Sonora or Yucatan or
from any other region not listed in Sec. 94.9(a) as a region where hog
cholera is not known to exist.
(d) The foreign meat inspection certificate accompanying the pork
or pork product (required by Sec. 327.4 of this title) includes a
statement certifying that the requirements in paragraphs (a), (b) (if
applicable), and (c) of this section have been met and, if applicable,
a list of the numbers of the seals required by paragraph (e)(1) of this
section.
(e) The shipment of pork or pork products has not been in any State
in Mexico other than Sonora or Yucatan or in any other region not
listed in Sec. 94.9(a) as a region where hog cholera is not known to
exist en route to the United States, unless:
(1) The pork or pork product arrives at the U.S. port of entry in
shipping containers bearing intact, serially numbered seals that were
applied at the federally inspected slaughter or processing plant in
either Sonora or Yucatan by a full-time salaried veterinarian of the
Government of Mexico, and the seal numbers correspond with the seal
numbers listed on the foreign meat inspection certificate; or
(2) The pork or pork product arrives at the U.S. port of entry in
shipping containers bearing seals that have different numbers than the
seal numbers on the foreign meat inspection certificate, but, upon
inspection of the hold, compartment, or container and all accompanying
documentation, an APHIS representative is satisfied that
[[Page 1537]]
the pork or pork product containers were opened and resealed en route
by an appropriate official of the Government of Mexico and the pork or
pork product was not contaminated or exposed to contamination during
movement from Sonora or Yucatan to the United States.
(Approved by the Office of Management and Budget under control
number 0579-0138)
Done in Washington, DC, this 6th day of January 2000.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 00-589 Filed 1-10-00; 8:45 am]
BILLING CODE 3410-34-P
