Importation of Sliced and Pre-Packaged Dry-Cured Pork Products

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 94

[Docket No. 96-066-2]

Importation of Sliced and Pre-Packaged Dry-Cured Pork Products

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending our regulations to allow dry-cured pork

products that have been sliced and packaged prior to shipment to the

United States to be imported into the United States under specified

conditions. This action will relieve some restrictions on the

importation of pork into the United States without presenting a

significant risk of introducing any serious communicable diseases of

animals.

EFFECTIVE DATE: December 15, 1997.

FOR FURTHER INFORMATION CONTACT: Dr. Julia Sturm, Supervisory Staff

Officer, Products Program, National Center for Import and Export, VS,

APHIS, Suite 3B66, 4700 River Road Unit 40, Riverdale, MD 20737-1231,

(301) 734-3277; or E-mail: [email protected]

SUPPLEMENTARY INFORMATION:

Background

The regulations in 9 CFR part 94 (referred to below as the

regulations) govern the importation into the United States of specified

animals and animal products to prevent the introduction of various

animal diseases, including rinderpest, foot-and-mouth disease, bovine

spongiform encephalopathy, hog cholera, African swine fever, and swine

vesicular disease, into the United States. These are dangerous and

destructive communicable diseases of ruminants and swine.

Under the regulations, certain animal products--whole hams, pork

shoulders, and pork loins--from regions where foot-and-mouth disease,

rinderpest, African swine fever, hog cholera, or swine vesicular

disease exists may be imported into the United States only under

certain conditions. To be eligible for importation, these products must

have been dry-cured and otherwise handled in accordance with procedures

specified in Sec. 94.17 of the regulations. However, the regulations

have not allowed these same products to be eligible for importation if

they have been sliced and packaged prior to shipment. We have

prohibited the importation of sliced and packaged dry-cured hams, pork

shoulders, and pork loins because of the difficulty in verifying the

origin of the meat and how it has been processed. Without this

information, we cannot easily determine whether the meat has been

treated and otherwise handled in a manner that ensures it is free of

disease agents.

On April 14, 1997, we published in the Federal Register (62 FR

18055-18059, Docket No. 96-066-1) a proposal to allow presliced and

prepackaged dry-cured pork to be imported into the United States under

certain conditions from countries 1 where foot-and-mouth

disease, rinderpest, swine vesicular disease, African swine fever, and

hog cholera exist. The proposed conditions were designed to ensure that

the origin of the pork and the method of processing could be verified.

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\1\ Since the proposed rule was published, we have amended our

regulations for importing animals and animal products to refer to

regions, rather than countries. See the paragraph headed

``Miscellaneous,'' elsewhere in this Supplementary Information

section.

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We solicited comments concerning our proposal for 60 days ending

June 13, 1997. We received 13 comments by that date. They were from

importers, foreign governments and meat processors, and one

veterinarian. The comments were primarily positive. Several comments

suggested changes in the proposed regulations. These suggestions are

discussed individually below.

Separation of Facilities

In our proposed rule, we required that the slicing/packaging

facility itself would have to be in a separate building, physically

detached from any area where pork or pork products are handled for

other purposes. This requirement was designed to prevent any possible

contamination of the meat.

Several commenters objected to this requirement as unnecessarily

restrictive. Commenters made various suggestions as to how we could

minimize contamination without requiring a separate building for the

slicing/packaging facility. Among the suggestions were: require workers

moving from the pork processing facility to the slicing/packaging

facility to change into either freshly laundered or disposable

clothing, including caps, masks, gloves and footwear; require a

``changing/scrub'' room for employees; and require ``walls, doors,

passageways, etc.''

After carefully considering these comments, we have determined that

our proposed requirement that the slicing/packaging facility be in a

separate building is overly restrictive. Having the

[[Page 61003]]

slicing/packaging facility in a separate building would achieve our

goal of separating the facilities so that disease agents cannot be

transmitted from areas in the facility where pork is cured and dried to

the slicing/packaging facility. However, it may not be practical in all

situations, and we believe the desired goal can be accomplished by

other means. Therefore, our final rule (Sec. 94.17(p)(1)(ii)) will

state that the slicing/packaging facility may either be in a separate,

physically detached building, or in a separate room within the same

building where the pork is cured and dried if the slicing and packing

room has no direct access to areas in the facility where pork is cured

and dried and if the room can be closed off from the rest of the

facility so unauthorized individuals cannot enter.

We are not making any changes based on the commenters' suggestions

regarding showering and clothing for workers. Our proposed rule

included a requirement (see Sec. 94.17(p)(1)(ix)) that workers in the

slicing/packaging facilities who handle dry-cured hams, pork shoulders,

and pork loins either shower and put on a full set of clean clothes, or

wait 24 hours after handling other pork or pork products before

handling dry-cured pork hams, pork shoulders, or pork loins in the

facility that are intended for importation into the United States. We

believe the commenters' suggestions are already covered by this

requirement.

Safeguards

One commenter objected that our proposed rule would eliminate

``critical safeguard and identification points.'' The commenter pointed

out that no individual identification would remain on the pork after

slicing and packaging, and that the Animal and Plant Health Inspection

Service (APHIS) would have to rely on ``paper certification'' and

records compiled by facilities that process, slice, and package dry-

cured pork products.

As discussed in our proposal, we believe that the combination of

inspection and recordkeeping requirements included in this rulemakng

will allow verification of the meat's origin, treatment, and handling.

Therefore, we have made no changes in response to this comment. Our

rule provides for periodic inspections of slicing/packaging facilities

(see proposed Sec. 94.17(p)(1)). These include inspections by both

APHIS personnel and personnel from the Food Safety Inspection Service

(FSIS) of the U.S. Department of Agriculture. In addition, our rule

requires slicing/packaging facilities to maintain specific, detailed

records on the source and identity of all dry-cured pork they handle

(see Sec. 94.17(p)(1)(iv)). Access to these records must be restricted

to officials of the national government of the region of origin,

representatives of the United States Government, and persons

maintaining the records (see Sec. 94.17(p)(1)(v)). In addition, APHIS

representatives, or individuals authorized by APHIS, will make

unannounced visits to inspect the facility and the required records

(see Sec. 94.17(p)(1)(viii)).

Since April 1987, similar recordkeeping and inspection requirements

have been in effect for facilities that cure and dry whole pork

products. These products have been imported into the United States

since 1988 without problems.

We realize that the effectiveness of our regulations is dependent

to some extent on the honesty and reliability of others. However, this

is also true in reverse: foreign governments rely on records maintained

by U.S. producers and processors, and on certificates issued by APHIS.

In a system of mutual reliance, we believe the possibility of

violations is minimized.

Under these circumstances, we believe our regulations are adequate

to protect the health of livestock in the United States.

Lot Numbers

One commenter suggested that we require lot numbers to be placed on

packages of sliced pork.

When drafting the proposed rule, we considered requiring the lot

number of the meat to appear on the label, or requiring that meat from

only one lot be in a package. However, as we explained in our proposed

rule, current industry practice is to label packages with the lot

number. Current industry practice is also to package only meat from one

lot in a package. Under these circumstances, it appears unnecessary to

include either requirement in our regulations. However, if industry

practices change, and we believe it is necessary to require lot numbers

or to require that only meat from one lot be in a package, we will

publish a proposal in the Federal Register for public comment.

Miscellaneous

On October 28, 1997, we published in the Federal Register (62 FR

56000--56026, Docket No. 94-106-9) a final rule establishing procedures

for recognizing regions, rather than only countries, for the purpose of

importation of animals and animal products into the United States. In

that rule, scheduled to be effective on November 28, 1997, we amended 9

CFR part 94 to remove the words ``country'' and ``countries'' and

replace them, respectively, with the words ``region'' and ``regions''.

To reflect these intervening changes, we have therefore adjusted the

language in this rule.

Executive Order 12866 and Regulatory Flexibility Act

This rule has been reviewed under Executive Order 12866. The rule

has been determined to be not significant for the purposes of Executive

Order 12866 and, therefore, has not been reviewed by the Office of

Management and Budget.

In accordance with 5 U.S.C. 603, we have performed a Final

Regulatory Flexibility Act Analysis, set forth below, regarding the

economic impact of this rule on small entities.

This final rule will amend the regulations regarding importation of

dry-cured pork products from regions where certain diseases of concern

exist, by providing that certain sliced and packaged products may be

imported into the United States under specified conditions.

We have used all available data to estimate the potential economic

effects of allowing these sliced and pre-packaged dry-cured pork

products to be imported into the United States. However, some of the

data we believe would be helpful in making this determination has not

been available. Specifically, data on: (1) The quantity of specialty

dry-cured hams produced domestically; (2) the quantity of potential

imports; and (3) the degree to which imported presliced and prepackaged

dry-cured pork products will displace existing imported or domestic

products, is not available. In our proposed rule, we invited comments.

However, none of the comments we received addressed these economic

issues.

The pork products covered by the rule are specialty products, such

as Parma hams from Italy. These products are similar to other dry-cured

pork products consumed in the United States, some imported from other

countries and some produced domestically. Currently, only whole dry-

cured pork hams, pork shoulders, and pork loins are being imported into

the United States. Slightly less than 3 million pounds of such whole

products were imported in 1995, the most recent year for which figures

are available. Presliced and prepackaged dry-cured pork products are

not being imported into the United States at this time.

We estimate that fewer than 15 domestic companies produce dry-cured

[[Page 61004]]

pork products similar to those covered by this final rule as a primary

or major product line. At least two of these companies are very large,

and these types of products constitute only a small fraction of their

overall business. Of the others, four are subsidiaries of Italian or

Swiss companies.

There are also a number of other producers of cured and smoked hams

who may produce similar products. If they do, this final rule could

affect them. In addition, there are approximately 10 domestic

establishments that buy cured hams and trim and dress them for resale.

Some of the resulting products might be similar to the presliced and

prepackaged products covered by this rule. If so, these businesses

could also be affected by this final rule.

This rule contains various recordkeeping requirements, which were

described in our proposed rule, and which have been approved by the

Office of Management and Budget.

Executive Order 12988

This 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.

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 final rule have been approved by the Office of

Management and Budget (OMB) under OMB control number 0579-0015.

Regulatory Reform

This action is part of the President's Regulatory Reform

Initiative, which, among other things, directs agencies to remove

obsolete and unnecessary regulations and to find less burdensome ways

to achieve regulatory goals.

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, 9 CFR part 94 is amended 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).

Sec. 94.17 [Amended]

2. Section 94.17 is amended as follows:

a. By revising the introductory text to read as set forth below.

b. In paragraph (d), by adding the word ``whole'' immediately

before the word ``ham,''.

c. In paragraph (e), by adding the word ``whole'' immediately after

the words ``was processed''; and in footnote 14, by removing the words

``9 CFR part 301, et seq.'' and adding the words ``9 CFR, chapter III''

in their place.

d. In paragraph (f), by adding the word ``whole'' immediately after

the words ``was processed''.

e. In paragraph (g), by adding the word ``whole'' immediately after

the words ``was processed'', and by removing the words ``within 12

months''.

f. In the introductory text of paragraph (h), and in the

introductory text of paragraph (i), by adding the word ``whole''

immediately after the words ``was processed''.

g. In paragraphs (j)(1), (j)(2), (j)(3), (k), (l), and (n), by

adding the word ``whole'' immediately after the first word ``The'' in

each paragraph.

h. In paragraph (j)(2), by adding the word ``whole'' immediately

before the words ``dry-cured pork shoulder''.

i. In paragraph (n), by removing the words ``trust fund agreement''

and adding the words ``cooperative service agreement'' in its place

each time it appears.

j. By adding a new paragraph (p) to read as set forth below.

Sec. 94.17 Dry-cured pork products from regions where foot-and-mouth

disease, rinderpest, African swine fever, hog cholera, or swine

vesicular disease exists.

Notwithstanding any other provisions in this part, dry-cured ham,

pork shoulder, or pork loin, whether whole or sliced and packaged,

shall not be prohibited from being imported into the United States if

it meets the following conditions:

* * * * *

(p) Whole hams, pork shoulders, and pork loins that have been dry-

cured in accordance with paragraph (i) of this section may be

transported to a facility in the same region for slicing and packaging

in accordance with this paragraph.

(1) The slicing/packaging facility. (i) The slicing/packaging

facility 2 must be inspected, prior to slicing and packaging

any hams, pork shoulders, or pork loins in accordance with this

paragraph, by an APHIS representative and determined by the

Administrator to be capable of meeting the provisions of this

paragraph.

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\2\ See footnote 14 in Sec. 94.17(e).

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(ii) The slicing/packaging facility must be either in a separate,

physically detached building, or in a separate room in the facility

where the whole ham, pork shoulder, or pork loin was dry-cured in

accordance with paragraph (i) of this section. If the slicing/packaging

facility is in a separate room, the room must have no direct access to

areas in the facility where pork is cured and dried and it must be

capable of being closed off from the rest of the facility so

unauthorized individuals cannot enter.

(iii) The slicing/packaging facility, including all equipment used

to handle pork and pork products, such as containers, work surfaces,

slicing machines, and packaging equipment, must be cleaned and

disinfected after sliced and packaged pork products that are not

eligible for export to the United States leave the facility, and before

whole dry-cured hams, pork shoulders, or pork intended for importation

into the United States enter the facility for slicing and packaging.

Cleaning and disinfecting must be adequate to ensure that disease

agents of concern are killed or inactivated and that pork products

intended for importation into the United States are not contaminated.

(iv) The slicing/packaging facility must maintain under lock and

key for a minimum of 2 years, original records on each lot of whole

dry-cured hams, pork shoulders, and pork loins entering the facility

for slicing and packaging under this section, including:

(A) The approval number of the facility where the whole ham,

shoulder, or loin was dry-cured in accordance with paragraph (i) of

this section;

(B) The date the whole ham, shoulder, or loin started dry-curing;

(C) The date the whole ham, shoulder, or loin completed dry-curing;

(D) The date the whole ham, shoulder, or loin was sliced and

packaged; and

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(E) A copy of all certifications required under paragraph (p) of

this section.

(v) Access to records required to be maintained under paragraph (p)

of this section must be restricted to officials of the national

government of the region of origin, representatives of the United

States Government, and persons maintaining the records.

(vi) The operator of the slicing/packaging facility must have

signed a cooperative service agreement with APHIS prior to receipt of

the whole dry-cured hams, pork shoulders, or pork loins for slicing and

packaging, stating that all hams, pork shoulders, or pork loins sliced

and packaged at the facility for importation into the United States

will be sliced and packaged only in accordance with this section.

(vii) The operator of the slicing/packaging facility must be

current, in accordance with the terms of the cooperative service

agreement signed with APHIS, in paying all costs for an APHIS

representative to inspect the establishment, including travel, salary,

subsistence, administrative overhead, and other incidental expenses.

(viii) The slicing/packaging facility must allow the unannounced

entry into the establishment of APHIS representatives, or other persons

authorized by the Administrator, for the purpose of inspecting the

establishment and records of the establishment.

(ix) Workers at the slicing/packaging facility who handle pork or

pork products in the facility must shower and put on a full set of

clean clothes, or wait 24 hours after handling pork or pork products

that are not eligible for importation into the United States, before

handling dry-cured hams, pork shoulders, or pork loins in the slicing/

packaging facility that are intended for importation into the United

States.

(x) Pork products intended for importation into the United States

may not be in the slicing/packaging facility at the same time as pork

products not intended for exportation to the United States.

(2) Slicing and packaging and labeling procedures. (i) A full-time

salaried veterinarian employed by the national government of the region

of origin must inspect each lot of whole dry-cured hams, pork

shoulders, and pork loins at the slicing/packaging facility, before

slicing is begun, and must certify in English that it is eligible for

importation into the United States in accordance with this section; and

(ii) Either a full-time salaried veterinarian employed by the

national government of the region of origin, or, if the national

government of the region of origin recognizes a local consortium as

responsible for product quality, a representative of that local

consortium, must certify in English that he or she personally

supervised the entire process of slicing and packaging each lot of dry-

cured hams, pork shoulders, and pork loins at the slicing/packaging

facility; that each lot of dry-cured hams, pork shoulders, and pork

loins was sliced and packaged in accordance with the requirements of

this paragraph; and that the sliced and packaged pork ham, shoulder, or

loin is the same dry-cured ham, pork shoulder, or pork loin certified

under paragraph (p)(2)(i).

(iii) The sliced and packaged dry-cured pork ham, pork shoulder, or

pork loin must be labeled with the date that processing of the meat

under paragraph (i) of this section began, and with the date the meat

was sliced and packaged.

(Approved by the Office of Management and Budget under control

number 0579-0015)

Done in Washington, DC, this 7th day of November 1997.

Charles Schwalbe,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 97-29989 Filed 11-13-97; 8:45 am]

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