[Federal Register Volume 62, Number 220 (Friday, November 14, 1997)]
[Rules and Regulations]
[Pages 61002-61005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-29989]


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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

[[Page 61005]]

    (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]
BILLING CODE 3410-34-P