[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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  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: [email protected].

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............
                             -------------------------------------------
    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