Importation of Pork and Pork Products From Yucatan and Sonora, Mexico

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

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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

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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