[Federal Register Volume 68, Number 32 (Tuesday, February 18, 2003)]
[Proposed Rules]
[Pages 7722-7728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-3836]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 94

[Docket No. 01-040-1]
RIN 0579-AB38


Importation of Milk and Milk Products From Regions Affected With 
Foot-and-Mouth Disease

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the regulations regarding the 
importation of animal products to establish specific processing 
requirements for certain cheeses, butter, and butteroil imported from 
regions in which foot-and-mouth disease exists; these products are 
currently exempt from the requirements of the regulations. 
Additionally, we are proposing to require that those products, when 
imported from regions in which foot-and-mouth disease exists, be 
accompanied by government certification regarding the processing of the 
products. The proposed processing methods could also be used for other 
milk products that are currently eligible for importation under other 
conditions. We believe these actions are necessary to ensure that 
materials containing the foot-and-mouth disease virus are not imported 
into the United States.

DATES: We will consider all comments that we receive on or before April 
21, 2003.

ADDRESSES: You may submit comments by postal mail/commercial delivery 
or by e-mail. If you use postal mail/commercial delivery, please send 
four copies of your comment (an original and three copies) to: Docket 
No. 01-040-1, Regulatory Analysis and Development, PPD, APHIS, Station 
3C71, 4700 River

[[Page 7723]]

Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment 
refers to Docket No. 01-040-1. If you use e-mail, address your comment 
to [email protected]. Your comment must be contained in the 
body of your message; do not send attached files. Please include your 
name and address in your message and ``Docket No. 01-040-1'' on the 
subject line.
    You may read any comments that we receive on this docket in our 
reading room. The reading room is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue, SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 690-2817 before coming.
    APHIS documents published in the Federal Register, and related 
information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Dr. Karen James-Preston, Assistant 
Director, Technical Trade Services, National Center for Import and 
Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; 
(301) 734-8172.

SUPPLEMENTARY INFORMATION:

Background

    The regulations in 9 CFR part 94 (referred to below as the 
regulations) govern the importation into the United States of meat and 
other animal products, including milk and milk products, in order to 
prevent the introduction of various animal diseases, including 
rinderpest and foot-and-mouth disease (FMD). These are dangerous and 
destructive communicable diseases of livestock.
    FMD is a severe and highly contagious viral infection affecting 
cattle, deer, goats, sheep, swine, and other animals. The most 
effective means of eradicating FMD is by the slaughter of affected 
animals. FMD is endemic to more than two-thirds of the world and is 
considered to be widespread in parts of Africa, Asia, Europe, and South 
America. FMD occurs in over seven different serotypes and 60 subtypes. 
As FMD outbreaks have occurred in foreign regions, the United States 
has banned the importation of live ruminants and swine, and restricted 
the importation of many animal products, from countries affected by 
FMD. In the past few years, the United States has implemented 
prohibitions and restrictions in response to outbreaks in South 
America, the European Union, and Taiwan.
    Although FMD was eradicated in the United States in 1929, the virus 
could be reintroduced by a single infected animal, animal product, or 
person carrying the virus. Once introduced, FMD can spread quickly 
through exposure to aerosols from infected animals, direct contact with 
infected animals, contact with contaminated feed or equipment, or 
contact with humans harboring the virus or carrying the virus on their 
clothing. It appears that FMD is primarily spread among livestock 
through aerosol, direct contact, or ingestion of animal products, 
including milk products. FMD could be introduced into the United States 
if milk or milk products carrying the FMD virus that have not been 
properly processed are imported into the United States and are ingested 
by ruminants or other livestock in the United States.

Current Regulations

    Section 94.16 of the regulations contains provisions governing the 
importation of milk and milk products from FMD-affected countries. With 
certain exceptions, the current provisions in Sec.  94.16 prohibit the 
importation of milk and milk products from regions in which FMD exists, 
unless the milk or milk product meets one of the conditions set forth 
in Sec.  94.16(b). The products that are exempted from the importation 
conditions are butter, butteroil, and cheese, except cheese with liquid 
or containing any item prohibited or restricted from importation under 
the regulations unless such item is independently eligible for 
importation under part 94. Except for these exempted articles, milk and 
milk products may not be imported from any region designated in Sec.  
94.1(a)(1) as a region in which rinderpest or FMD exists unless the 
milk or milk products meet one of the following conditions:
    1. They are in a concentrated liquid form and have been processed 
by heat by a commercial method in a container hermetically sealed 
promptly after filling but before such heating, so as to be shelf 
stable without refrigeration.
    2. They are dry milk or dry milk products, including dry whole 
milk, nonfat dry milk, dried whey, dried buttermilk, and formulations 
that contain any such dry milk products, and are consigned directly to 
an approved establishment for further processing in a manner approved 
by the Administrator of the Animal and Plant Health Inspection Service 
(APHIS) as adequate to prevent the introduction or dissemination of 
livestock diseases into the United States. However, in specific cases, 
upon request by the importer to the Administrator, and approval by the 
Administrator, they may be stored for a temporary period in an approved 
warehouse under the supervision of an APHIS inspector pending movement 
to an approved establishment. Such products must be transported from 
the port of first arrival to an approved establishment or an approved 
warehouse, and from an approved warehouse to an approved establishment 
only under Department seals or seals of the U.S. Customs Service. Such 
seals may be broken only by an APHIS inspector or other person 
authorized to do so by the Administrator. Such products may not be 
removed from the approved warehouse or approved establishment unless 
the Administrator gives special permission and all the conditions and 
requirements specified by the Administrator are complied with.
    3. Milk and milk products not exempted from the importation 
conditions and not meeting conditions 1 or 2 above may be imported if 
the importer first applies for and receives written permission from the 
Administrator authorizing such importation. Permission will be granted 
only when the Administrator determines that such action will not 
endanger the health of the livestock of the United States. Products 
subject to this provision include, but are not limited to, condensed 
milk, long-life milks such as sterilized milk, casein and caseinates, 
lactose, and lactalbumin. Additionally, small amounts of milk and milk 
products that would otherwise be prohibited from being imported into 
the United States may, in specific cases, be imported for examination, 
testing, or analysis if such importation is approved by the 
Administrator.
    In light of recent FMD outbreaks in the European Union, South 
America, and elsewhere, we have reviewed the scientific literature and 
have determined that permitting the importation into the United States 
of butter, butteroil, and certain cheeses without their meeting 
specific importation conditions could pose an unacceptable risk of 
introducing the FMD virus into the United States. The literature we 
reviewed \1\ indicates that

[[Page 7724]]

the FMD virus could survive in those exempted products, so we believe 
that it is necessary to provide specific processing requirements for 
these products as a condition of their importation. These proposed 
processing methods are consistent with the Office International des 
Epizooties (OIE) standards. We are, therefore, proposing to remove the 
exemptions from importation conditions for the milk products listed in 
Sec.  94.16(a) and instead would provide specific conditions (i.e., 
processing methods) under which those products could be imported. These 
processing methods could also be used for other products that are 
already eligible for importation under the conditions in Sec.  94.16, 
including, but not limited to, condensed milk, long-life milks such as 
sterilized milk, cream, cheeses, whey, casein and caseinates.
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    \1\ See: Blackwell, J.H., ``Survival of Foot-and-Mouth Disease 
Virus in Cheese,'' 1976, Journal of Dairy Science, Vol. 59, No. 9, 
pp. 1574-1579.
    Sellers, R.F., ``Inactivation of Foot-and-Mouth Disease Virus in 
Milk,'' 1969, British Veterinary Journal, Vol. 125, No. 4, pp. 163-
168.
    Cunliffe, H.R., et al., ``Inactivation of Milkborn Foot- and 
Mouth Disease Virus at Ultra-High Temperatures,'' 1979, Journal of 
Food Protection, Vol. 42, No. 2, pp. 135-137.
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    Under this proposed rule, the milk products now listed as exempt in 
Sec.  94.16(a) could be imported into the United States from a region 
affected with FMD only if they have been produced using one of the 
processing methods described below:
    1. Milk or milk products (other than cheese) that are, or are made 
from, milk that has been treated at ultra-high temperature (UHT)(298.4 
[deg]F (148 [deg]C) for 3 seconds or 284 [deg]F (140 [deg]C) for 5 
seconds).
    2. Milk or milk products (other than cheese) that are, or are made 
from, milk that has been treated at a high temperature for a short time 
(HTST) (161.6 [deg]F (72 [deg]C) for 15 seconds), followed by a second 
HTST treatment. For milk products made with added fat or added 
concentrates, the treatment temperature would have to be increased to 
167 [deg]F (75 [deg]C).
    3. Milk products made from milk that is HTST-treated then brought 
to a pH of less than 6 for 1 hour.
    4. Cheese made from raw milk, aged at a temperature of greater than 
35.6 of (2 [deg]C) with a pH of less than 6 for 120 days prior to 
export from the country of origin.
    5. Cheese made from HTST milk, aged at a temperature of greater 
than 35.6 of (2 [deg]C) with a pH of less than 6 for 30 days prior to 
export from the country of origin.
    The scientific evidence available to us indicates that each of the 
methods described above is sufficient to inactivate the FMD virus in 
milk and milk products.
    We would also require that any milk or milk product imported under 
these proposed conditions (i.e., the butter, butteroil, and cheeses 
that would have to meet one of those conditions, as well as any other 
milk or milk product for which one of those methods was used as an 
alternative to meeting the existing importation conditions in Sec.  
94.16) be accompanied by an official veterinary certificate endorsed by 
a full-time, salaried veterinarian employed by the region of origin 
attesting to the completion of the appropriate processing. The 
certificate would help ensure that the required processing has been 
performed by requiring that a representative responsible for animal 
health in the exporting region verifies that the treatment has been 
carried out.

Additional Changes

    We are proposing to add ice cream and chocolate milk to the 
examples of milk products in current Sec.  94.16 (b)(3) that may be 
eligible for importation based on written permission from the 
Administrator. We are proposing to specifically cite ice cream and 
chocolate milk as products requiring written permission to minimize the 
chance that these products may accidentally be diverted into the animal 
food chain.
    We are also proposing to require that the examination, testing, and 
analysis of small amounts of milk and milk products allowed for 
importation under current Sec.  94.16(b)(4) occur in a laboratory 
setting. This action would ensure that untreated samples would not 
enter the United States to be sold at trade shows or fairs.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed 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.
    We are proposing to amend the regulations regarding the importation 
of animal products to establish specific processing requirements for 
certain cheeses, butter, and butteroil imported from regions in which 
FMD exists. Those processing methods could also be used for other milk 
and milk products that are already eligible for importation under 
different conditions, thus allowing their importation under a greater 
variety of conditions. Additionally, we are proposing to require that 
products imported from regions in which FMD exists and processed using 
one of the proposed methods be accompanied by government certification 
regarding their processing. We believe these actions are necessary to 
ensure that products containing the FMD virus are not imported into the 
United States.
    The establishment of FMD in the United States could result in 
serious economic consequences, given the size of the Nation's livestock 
inventories and the volume of animal and animal product sales. 
Potential losses associated with an outbreak of FMD include production 
losses at affected establishments, eradication and quarantine costs, 
and trade restrictions.\2\ Production losses arise from lost production 
on depopulated premises and in the industries linked to the livestock 
sector. There would also be additional costs to be borne by producers 
and slaughterers, as restrictions would be imposed to prevent the 
spread of FMD and eradicate the disease within the United States. These 
restrictions and eradication measures would also mean added costs to 
the government for implementation and enforcement.
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    \2\ Ekboir, Javier M., ``Potential Impact of Foot-and-Mouth 
Disease in California,'' 1999, Agricultural Issues Center, Division 
of Agriculture and Natural Resource, University of California.
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    FMD outbreaks in the spring of 2001 in the United Kingdom 
illustrate these costs. Control of FMD in the United Kingdom became a 
nationwide undertaking, with restrictions on the movement of animals 
(and people), large-scale slaughter of animals on affected and 
neighboring farms, and disposal of carcasses through burning, 
rendering, or burial. The last case of FMD in the United Kingdom was 
found on September 30, 2001; by the time the United Kingdom declared 
the outbreak eradicated on January 14, 2002, 586,551 cattle, 3,466,493 
sheep, 148,388 pigs, 2,482 goats, 1,021 deer, and 770 other animals had 
been slaughtered.\3\ In addition, the European Union banned the export 
of meat, livestock, and milk products from the United Kingdom. As is 
shown below, the United States is a major exporter of products whose 
international movement could be affected by an outbreak of FMD in the 
United States. In addition to a likely reduction in demand from 
international consumers, trading partners of the United States would 
likely impose restrictions on, and reduce imports of, U.S. ruminants, 
swine, and some of their products in the event of an FMD outbreak in 
the United States.
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    \3\ UK Department for Environment, Food & Rural Affairs.
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    According to ``Agricultural Statistics 2001,'' published by 
National Agricultural Statistics Service (NASS), cattle in U.S. herds 
in 2000 were valued at $67.1 billion, with 1999 cash receipts

[[Page 7725]]

of $36.5 billion from the sale of cattle, calves, beef, and veal. Cash 
receipts from the sale of milk and cream in 1999 reached $23.2 billion. 
U.S. hogs and pigs in 2000 were valued at $4.6 billion, with 1999 cash 
receipts from the sale of hogs, pork, and lard totaling $8.6 billion. 
Sheep and lamb inventories in 2000 were valued at $668.8 million, with 
1999 cash receipts of $468.8 million from the sale of live sheep and 
lambs and of mutton and lamb. The value of U.S. wool production in 1999 
totaled about $17.9 million.
    U.S. exports of live bovines, swine, sheep, and goats were valued 
at $304.5 million in 2000. U.S. exports of fresh beef, pork, and sheep 
and goat meat totaled $4.4 billion in 2000. U.S. exports of fresh 
ruminant and swine products other than meat were valued at $718.4 
million in 2000. U.S. exports of prepared and preserved ruminant and 
swine meat products such as sausages and cured, salted, and dried meats 
were valued at $375.5 million in 2000. U.S. exports of dairy products 
totaled $784.1 million in 2000. In addition, the United States exports 
a great number of other ruminant and swine products including 
germplasm, hides and skins, animal feeds, dairy products, bones, hair, 
guts, and glands.
    In order to help prevent an outbreak of FMD in the United States, 
and thus protect the substantial domestic and export market described 
above, imports of certain cheeses, butter, and butteroil from regions 
affected with FMD would be subject to specific processing requirements 
as a result of this proposed rule. Other products, including milk, 
cream, casein, whey, caseinates, and ice cream, which are already 
eligible for importation under different conditions, could also be 
processed using the proposed methods as an alternative to meeting the 
existing requirements governing the importation of those products. 
Those products, as previously discussed, would need to be accompanied 
by an official veterinary certificate that attests to the completion of 
the appropriate processing. U.S. imports of these products in 2000 from 
regions affected with FMD and the world are shown in Table 1.

                             Table 1.--U.S. Imports of Milk and Milk Products, 2000
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                                                                  From  FMD
                                                                   affected      From  FMD free    U.S. global
                       Product imported                          regions  (in     regions  (in     imports  (in
                                                                  millions)        millions)        millions)
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Milk and cream, not concentrated.............................            $0.73            $9.65           $10.38
Milk and cream, concentrated or sweetened....................             2.78            31.51            34.29
Butter and other fats and oils derived from milk.............             0.65            34.44            35.09
Cheese and curd..............................................           140.53           556.10           696.63
Ice cream....................................................             2.38            15.25            17.62
Casein and caseinates........................................            98.81           401.57           500.38
Other milk products..........................................            15.25           157.06          172.31
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Source: World Trade Atlas, Global Trade Information Services, Inc.

    Approximately 9 percent of these imports were from regions affected 
with FMD. Information on the portion of butter, butteroil, and cheese 
imports from FMD-affected regions that do not currently meet the 
proposed requirements is not available. However, the impact of the 
proposed changes is expected to be small. Imports in total are small 
relative to domestic production. For example, butter imports totaled 
18,059 metric tons in 1999, while domestic production of butter was 
578,349 metric tons. In addition, APHIS anticipates that the majority 
of these imports currently meet, or could relatively easily be made to 
meet, the requirements described in this proposed rule, as most 
processors already possess and use the equipment necessary to meet the 
proposed standards. In addition, certain products (i.e., dry milk and 
dry milk products including dry whole milk, nonfat dry milk, dried 
whey, dried buttermilk, and formulations which contain any such dry 
milk products) would continue to be eligible for importation under 
existing regulations and would not be required to meet the specific 
proposed requirements.
    For most types of cheese imported into the United States, this 
proposed rule should have little impact. At a total of 197,537 metric 
tons in 1999, the amount of imported cheese was equal to about 5 
percent of domestic cheese production, which was about 3.6 million 
metric tons. In addition, most U.S. imports of cheese currently meet or 
should be able to meet the requirements for time, temperature, and pH 
level in this proposed rule. There are notable possible exceptions to 
this. The aging requirement in the proposed rule may affect the 
importation of some cheeses, as additional aging may alter the 
character of some cheeses made with raw milk and some cheeses with eye-
formation such as Swiss cheese, thus making them less desirable or 
unavailable for importation. In 1999, the United States produced about 
100,000 metric tons, and imported more than 34,000 metric tons, of 
Swiss cheese. Table 2 shows U.S. imports of Swiss type cheeses and 
their origin in 1998 through 2000. The extent to which imports of Swiss 
cheese and raw milk cheese may be altered as a result of the proposed 
rule is unknown. However, the effect should be exceedingly small, as 
more than 99 percent of U.S. Swiss cheese imports in 2000 originated in 
FMD-free countries.

                 Table 2.--U.S. Imports of Swiss Cheese
                            [in metric tons]
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        Country of origin              1998         1999         2000
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Austria..........................        1,269        1,109        1,298
Canada...........................          346          369          183
Denmark..........................        1,428        3,417        2,585
Finland..........................        5,872        6,908        8,124
France...........................        1,371          984        1,390

[[Page 7726]]

 
Germany..........................        3,858        6,477        4,633
Hungary..........................          790          792          357
Ireland..........................        1,021        1,124          818
Netherlands......................          374          424          213
Norway...........................        7,510        7,254        7,709
Switzerland......................        3,416        3,516        3,498
Other countries..................        1,773        2,816        3,082
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    In addition to the specific processing requirements for butter, 
butteroil, and certain cheeses imported from regions affected by FMD, 
this proposed rule would also require government certification that 
those requirements have been met. The cost of obtaining certification 
may affect the price of the product paid by U.S. importers and end 
users. However, the cost of obtaining such certification is expected to 
be low. The certification is simply a signed statement from the 
veterinary official of the exporting country attesting that the 
requirements have been met. Certification would be a new requirement 
for cheese (without liquid or restricted items), butter, and butteroil. 
Under the current regulations, these items may enter without 
restriction. In 2000, about 40 percent of the $530 million in milk and 
milk products imported from FMD-affected countries were cheese and 
butter.
    For some other imports, the proposed rule would expand import 
options. For example, certain products such as condensed milk, long-
life milks such as sterilized milk, casein and caseinates, lactose and 
lactalbumin, are currently allowed entry if written permission is given 
for their importation, and other products such as dry milk or dry milk 
products are currently allowed entry only if consigned to an approved 
facility for further processing. If any of these products were produced 
using milk processed in accordance with methods described in this 
proposal, those products would be eligible for importation if 
accompanied by the certification described in the previous paragraph. 
The number of producers in FMD-affected regions that might opt to use 
the processing methods described in this proposed rule for these 
products is unknown. We expect that those producers would use UHT-or 
HTST-treated milk in the preparation of their products if that option 
was viable from a production standpoint and was an economically 
attractive alternative to the existing requirements in Sec.  94.16 
governing the importation of these products.
    The quantity of imports from FMD-affected regions that might be 
produced using milk treated in accordance with this proposed rule is 
not known, nor is the degree to which that treatment might affect the 
cost of those imports.
    As this proposed rule would simply provide an alternative to the 
current importation provisions for milk and milk products other than 
butter, butteroil, and cheese, we expect that the effect of this 
proposed rule on imports of those products, which in 2000 constituted 
about 60 percent of milk and milk product imports from FMD-affected 
regions, would be small.

Cost/Benefit Analysis

    This proposed rule may involve added costs for importers and users 
of butter, butteroil, and certain cheeses, as those imports from FMD-
affected regions would be required to meet new processing and 
certification requirements. However, because FMD-affected regions 
account for a small portion of all U.S. imports of these products and 
represent an even smaller fraction of domestic production and overall 
supply, the impacts on domestic prices and consumption will be small. 
Moreover, these costs are very small when compared to the benefits of 
preventing an outbreak of FMD in the United States. Such an outbreak 
could have serious economic consequences given the size of the nation's 
livestock inventories and the volume of animal and animal product 
sales.

Impact on Small Entities

    The Regulatory Flexibility Act requires that Agencies specifically 
consider the economic impact of their rules on small entities. Those 
entities most likely to be affected by the proposed rule are domestic 
importers of milk and milk products, domestic users of these products, 
and dairy farms.
    The Small Business Administration (SBA) has established guidelines 
for determining which establishments are to be considered small 
entities under the Regulatory Flexibility Act. According to North 
American Industry Classification System (NAICS) codes 422430 and 
422490, import/export merchants, agents, and brokers are identified in 
the wholesaling trade. A firm engaged in wholesaling dairy products is 
considered small if it employs fewer than 100 persons. In 1997, more 
than 97 percent (2,460 of 2,522) of dairy products (except dried or 
canned) wholesalers would be considered small, and more than 95 percent 
(12,251 of 12,845) of other grocery and related products wholesalers, 
which includes dried and canned dairy products, would be considered 
small.\4\ An establishment engaged in dairy cattle and milk production 
(NAICS code 112111) is considered small if it has annual sales of less 
than $750,000. According to the 1997 Census of Agriculture, at least 
79,155 of 86,022 (or 92 percent) of dairy farms would be considered 
small. The size standards for establishments engaged in food 
manufacturing range from fewer than 500 employees to fewer than 1,000 
employees, depending on the type of food being manufactured. An 
establishment engaged in dairy product manufacturing (NAICS code 3115) 
is considered small if it employs fewer than 500 persons. This is also 
the standard for non-chocolate confectionary manufacturing, NAICS code 
311340, which includes granola and other types of breakfast bars. In 
1997, 25,729 of 26,302 (or more than 97 percent) of food manufacturing 
establishments would be considered small.\5\
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    \4\ 1997 Economic Census, Department of Commerce, Bureau of the 
Census.
    \5\ 1997 Economic Census, Department of Commerce, Bureau of the 
Census.
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    From the above it is clear that any domestic entity affected by 
this proposed rule is likely to be considered small. However, for most 
milk products, the quantity imported is a small fraction of that 
produced domestically, and the quantity of imports supplied by FMD-
affected regions is a smaller percentage still of domestic supply. 
Thus, the

[[Page 7727]]

impact of this proposed rule on small entities is expected to be small.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action would 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed rule is adopted: (1) All State 
and local laws and regulations that are inconsistent with this rule 
will be preempted; (2) no retroactive effect will be given to this 
rule; and (3) administrative proceedings will not be required before 
parties may file suit in court challenging this rule.

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this proposed rule have been 
submitted for approval to the Office of Management and Budget (OMB). 
Please send written comments to the Office of Information and 
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, 
DC 20503. Please state that your comments refer to Docket No. 01-040-1. 
Please send a copy of your comments to: (1) Docket No. 01-040-1, 
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 
River Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance 
Officer, OCIO, USDA, room 404-W, 14th Street and Independence Avenue, 
SW., Washington, DC 20250. A comment to OMB is best assured of having 
its full effect if OMB receives it within 30 days of publication of 
this proposed rule.
    We are proposing to amend the regulations regarding the importation 
of animal products to establish new processing requirements for butter, 
butteroil, and certain cheeses imported from regions in which FMD 
exists. Additionally, we are proposing to require that those materials, 
as well as other milk or milk products that are processed using the new 
proposed methods in lieu of meeting the existing importation 
conditions, when imported from regions in which foot-and-mouth disease 
exists, be accompanied by government certification by a salaried 
veterinarian employed by the region of origin regarding the processing 
of the materials.
    We are asking OMB to approve, for 3 years, our use of this 
information collection activity in connection with our efforts to 
ensure that milk and milk products imported into the United States from 
FMD regions do not harbor the FMD virus.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. These comments will help us:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 0.25 hours per response.
    Respondents: Exporters of milk and milk products in FMD regions; 
full-time, salaried veterinarians employed by the region of origin.
    Estimated annual number of respondents: 200.
    Estimated annual number of responses per respondent: 5.
    Estimated annual number of responses: 1,000.
    Estimated total annual burden on respondents: 250 hours. (Due to 
averaging, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the reporting burden per 
response.) Copies of this information collection can be obtained from 
Mrs. Celeste Sickles, APHIS'' Information Collection Coordinator, at 
(301) 734-7477.

Government Paperwork Elimination Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the Government Paperwork Elimination Act (GPEA), which 
requires government agencies in general to provide the public the 
option of submitting information or transacting business electronically 
to the maximum extent possible. For information pertinent to GPEA 
compliance related to this proposed rule, please contact Mrs. Celeste 
Sickles, APHIS'' Information Collection Coordinator, at (301) 734-7477.

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 propose to amend 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 would continue to read as 
follows:

    Authority: 7 U.S.C. 450, 7701-7772, and 8301-8317; 21 U.S.C. 136 
and 136a; 31 U.S.C. 9701; 42 U.S.C. 4331 and 4332; 7 CFR 2.22, 2.80, 
and 371.4.

    2. Section 94.16 would be amended as follows:
    a. By removing paragraph (a) and redesignating paragraphs (b), (c), 
and (d) as paragraphs (a), (b), and (c), respectively.
    b. In newly redesignated paragraph (a), by revising the 
introductory text of the paragraph; redesignating paragraphs (a)(1) 
through (a)(4) as paragraphs (a)(6) through (a)(9), respectively; and 
by adding new paragraphs (a)(1) through(a)(5) to read as follows.
    c. In newly redesignated paragraph (a)(8), by revising the first 
sentence to read as follows, and in the last sentence, by adding the 
words ``ice cream, chocolate milk,'' after the word ``lactose''.
    d. In newly redesignated paragraph (a)(9), by adding the words ``in 
a laboratory setting'' after the word ``analysis''.
    e. In newly redesignated paragraph (c), in the last sentence, by 
removing the citation Sec.  94.16(b)(3)'' and adding the words 
``paragraph (a)(8) of this section'' in its place.


Sec.  94.16  Milk and milk products.

    (a) Milk and milk products originating in, or shipped from, any 
region designated in Sec.  94.1(a) as a region infected with rinderpest 
or foot-and-mouth disease may be imported into the United States if the 
milk or milk product satisfies one of the sets of criteria described in 
paragraphs (a)(1) through (a)(9) of this section. Products processed in 
accordance with one of the methods described in paragraphs (a)(1) 
through (a)(5) of this section must be accompanied by an official 
veterinary

[[Page 7728]]

certificate endorsed by a full-time, salaried veterinarian employed by 
the region of origin stating that the products have been processed in 
accordance with one of those methods:
    (1) Milk or milk products (other than cheese) that are, or are made 
from, milk that has been treated at an ultra high temperature (298.4 
[deg]F (148 [deg]C ) for 3 seconds or 284 [deg]F (140 [deg]C) for 5 
seconds); or
    (2) Milk or milk products (other than cheese) that are, or are made 
from, milk that has been treated at a high temperature for a short time 
(HTST) (161.6 [deg]F (72 [deg]C) for 15 seconds) followed by a second 
HTST (161.6 [deg]F (72 [deg]C) for 15 seconds) treatment. For milk 
products made with added fat or added concentrates, the treatment 
temperature must be increased to 167 [deg]F (75 [deg]C); or
    (3) Milk products made from HTST milk that is brought to a pH of 
less than 6 for 1 hour.
    (4) Cheese made from raw milk, aged at a temperature of greater 
than 35.6 [deg]F (2 [deg]C) with a pH of less than 6 for 120 days prior 
to export from the country of origin; or
    (5) Cheese made from HTST milk, aged at a temperature of greater 
than 35.6 [deg]F (2 [deg]C) with a pH of less than 6 for 30 days prior 
to export from the country of origin.
* * * * *
    (8) Milk and milk products not of classes included within the 
provisions of paragraphs (a)(1) through (a)(7) of this section may be 
imported if the importer first applies to and receives written 
permission from the Administrator, authorizing such importation. * * *
* * * * *

    Done in Washington, DC, this 11th day of February, 2003.
Bill Hawks,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 03-3836 Filed 2-14-03; 8:45 am]
BILLING CODE 3410-34-P