E6-22629. Importation of Uncooked Pork and Pork Products

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Proposed rule.

SUMMARY:

We are proposing to amend the regulations for importing animal products to allow the importation of uncooked pork and pork products from regions where classical swine fever (CSF) is considered to exist if the uncooked pork and pork products originate in a region free of CSF and meet certain other conditions with respect to processing and shipping. This action would remove some restrictions on the importation of uncooked pork and pork products from regions where CSF is considered to exist while continuing to protect against an incursion of CSF into the United States.

DATES:

We will consider all comments that we receive on or before March 6, 2007.

ADDRESSES:

You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov, select “Animal and Plant Health Inspection Service” from the agency drop-down menu, then click “Submit.” In the Docket ID column, select APHIS-2006-0186 to submit or view public comments and to view supporting and related materials available electronically. Information on using Regulations.gov, including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's “User Tips” link.
• Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. APHIS-2006-0186, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2006-0186.

Reading Room: 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 [phone] before coming.

Other Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT:

Dr. Masoud A. Malik, Senior Staff Veterinarian, Technical Trade Services, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 40, Riverdale, MD 20737-1231, [phone].

SUPPLEMENTARY INFORMATION:

Background

The regulations in 9 CFR part 94 prohibit or restrict the importation of certain animals and animal and poultry products into the United States to prevent the introduction of communicable diseases of livestock and poultry. Section 94.9 contains requirements that apply to the importation of pork and pork products from regions where classical swine fever (CSF) exists.

Currently, the regulations provide that pork and pork products may be imported into the United States from regions where CSF exists only if they have been cooked or cured in the affected region as specified in our regulations. This is the case even if the pork or pork products originated in a region free of CSF but were imported through a region where CSF exists.

We are proposing to allow the importation, under certain conditions, of uncooked pork and pork products from regions where CSF is considered to exist if the pork and pork products originate in a region free of CSF. The primary purpose of this proposed change is to allow uncooked pork and pork products that originate in the United States to be shipped for processing to Mexico, which contains areas where CSF is considered to exist, and then be returned to the United States.^[1] The proposal would, however, also allow uncooked pork and pork products that originate in another CSF-free region to be processed in a region where CSF is considered to exist and then be shipped to the United States. If the region of origin is free of CSF but affected with another serious livestock disease such as African swine fever (ASF), swine vesicular disease (SVD), foot-and-mouth disease (FMD), or rinderpest, the existing regulations for the importation of products from regions affected with those diseases would continue to govern imports from that region. This action would remove some restrictions on the importation of uncooked pork and pork products from regions where CSF is considered to exist while continuing to provide appropriate safeguards against an incursion of CSF into the United States.

Shipment To Approved Establishments

Under this proposed rule, uncooked pork or pork products that originate in a region free of CSF would have to be shipped for processing to the region where CSF is considered to exist in closed containers sealed with serially numbered seals applied by an official of the national government of the region of origin. The shipments would have to be accompanied by a certificate that was signed by an official of the national government of the region of origin and that specifies the products' region of origin, the slaughtering establishment where the animal was slaughtered and from which the products were shipped, the processing establishment to which the products are consigned, and the numbers of the seals applied to the shipping containers.

Upon arrival at the processing establishment, the uncooked pork or pork products could only be removed from the containers after an official of the national government of the region where the processing establishment is located had determined that the seals were intact and free of any evidence of tampering and the shipment is accompanied by the certificate described above.

Handling at Approved Establishments

Under this proposed rule, the uncooked pork or pork products would be eligible for importation to the United States only if they were handled and processed in accordance with the following criteria:

1. The processing establishment in a region where CSF is considered to exist would have to meet requirements of the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the regulations of the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA) in 9 CFR, chapter III, part 327. FSIS periodically audits foreign country inspection systems, including a sample of establishments, to make sure that all FSIS requirements are met. If there is indication that any FSIS requirements are not being met by a particular establishment, FSIS can terminate the eligibility of the foreign establishment to import its products into the United States as well as refuse entry of shipments that fail to meet their requirements. FSIS can issue a hold order to inspect shipments of pork and pork products coming from that establishment until they are certain that all FSIS requirements are being met.

2. The processing establishment that processes the uncooked pork and pork products for export to the United States could not receive or process any live swine, since CSF is easily spread in environments where swine are held or slaughtered.

3. The processing establishment would have to be dedicated to processing uncooked pork and pork products from CSF-free regions. No pork or pork products that originate in regions where CSF is considered to exist could be processed at the same facility as pork or pork products from CSF-free regions.

4. Operators of processing establishments would have to sign a compliance agreement with the Animal and Plant Health Inspection Service (APHIS), stating that all meat processed for importation to the United States would be processed in accordance with our requirements, that a full-time, salaried meat inspection official of the national government of the region where the processing facility is located would supervise the processing and examination of the product and certify that it has been processed in accordance with our requirements, and that APHIS personnel or other persons authorized by the Administrator may enter the establishment, unannounced, to inspect the establishment and its records.

5. The establishment operator or a party acting on its behalf would have to enter into a cooperative service agreement with APHIS to ensure that all expenses incurred by APHIS in inspecting the establishment would be paid by the operators of the processing establishment. APHIS anticipates that an initial evaluation would be conducted and that subsequent inspections would occur approximately once a year. The cooperative service account would be required to contain a balance at least equal to the cost of one inspection. APHIS would charge the cooperative service account for travel, salary, and subsistence of APHIS employees, as well as administrative overhead and other incidental expenses (including excess baggage charges up to 150 pounds).

In addition, the signed certificate which accompanied the shipment would have to be kept on file at the processing establishment for at least 2 years after the export of the processed products to the United States, and would have to be made available to USDA inspectors to demonstrate compliance with our regulations, when requested, during announced or unannounced inspections.

Shipment to the United States

Uncooked pork and pork products to be imported into the United States would have to be shipped from the region where they were processed in closed containers sealed with serially numbered seals applied by an official of the national government of that region. The shipments would have to be accompanied by a certificate signed by an official of the national government of the region where the uncooked pork and pork products were processed. The certificate would have to list the numbers of the seals applied; state that all of the conditions listed above have been met; and state that when the uncooked pork or pork products arrived at the processing establishment, the seals on the containers were intact and free of any evidence of tampering. A copy of this certificate would also have to be kept on file at the processing establishment for at least 2 years after the products were shipped to the United States.

We believe the conditions described above would ensure that the uncooked pork and pork products present a minimal risk of introducing CSF into the United States.

Executive Order 12866 and Regulatory Flexibility Act

This proposed 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.

We are proposing to amend the regulations for importing animal products to allow the importation of uncooked pork and pork products from regions where CSF is considered to exist if the uncooked pork and pork products originate in a region free of CSF and meet certain other conditions with respect to processing and shipping. This action would remove some restrictions on the importation of uncooked pork and pork products from regions where CSF is considered to exist while continuing to protect against an incursion of CSF into the United States. We expect the benefits of this rule to exceed costs, although neither benefits nor costs are likely to be significant.

The United States is a major producer as well as trader of swine and swine products. Total cash receipts from hogs and pigs were $15 billion in 2003, about 11 percent over the previous year. Marketing totaled 27.2 billion pounds in 2005.^[2] The United States exported a total of 1,811 million pounds valued at $2,068 million in 2005. Although exports are widely distributed, a few regions represent major markets. The major destinations include Japan (51.28 percent), Mexico (14.54 percent), Canada (13.06 percent), South Korea (6.47 percent), Russia (2.58 percent), Australia (2.38 percent), Romania (2.29 percent), and Taiwan (1.55 percent). These regions accounted for 94.15 percent of U.S. fresh or frozen pork exports in 2005. The most recent data (January-September 2006) also show the same pattern, with the above-named regions accounting for 93.96 percent of U.S. total fresh or frozen pork exports during that period.^[3]

The United States imported 793 million pounds of fresh or frozen pork valued at $945 million in 2005. Most of the imports were from Canada (78.93 percent) and Denmark (16.40 percent). Other regions that supplied pork include Ireland (1.29 percent), United Kingdom (1.14 percent), Netherlands (0.99 percent), Finland (0.51 percent), Sweden (0.25 percent), Australia (0.01 percent), Mexico (0.45 percent), and Germany (0.03 percent). The 2006 (January-September) imports also show the same pattern. The United States imported 566 million pounds of fresh or frozen pork valued at $655 million for this partial year. (See table 1.)

Table 1.—U.S. Imports of Fresh or Frozen Pork, 2002-2006

Source	2002		2003		2004		2005		2006 (Jan.-Sept.)
	Million dollars	Million lbs	Million dollars	Million lbs	Million dollars	Million lbs	Million dollars	Million lbs	Million dollars	Million lbs
Canada	571.936	717.653	644.806	770.337	760.886	706.22	745.496	694.75	507.718	485.886
Denmark	132.211	82.126	156.324	100.829	182.794	102.95	154.933	76.01	114.042	63.095
Ireland	7.511	5.076	9.998	6.406	128.38	6.37	12.192	5.711	7.246	3.251
Finland	3.673	2.344	2.115	1.813	6.792	4.82	4.797	2.99	4.311	2.401
Netherlands	0.054	0.042	0	0	8.511	4.24	9.373	4.96	9.627	5.110
United Kingdom	2.205	1.464	4.281	3.282	4.184	2.25	10.787	4.82	5.48	2.347
Mexico	0	0	0.949	0.864	2.498	1.60	4.212	2.29	3.669	2.349
Sweden	0	0	0.098	0.090	2.950	1.61	2.400	1.230	1.635	0.757
Germany	9.437	0.362	9.353	0.303	0	0	0.319	0.26	0.381	0.201
Australia	0.121	0.066	0.038	0.027	0.05	0.020	0.056	0.053	0	0
New Zealand	0	0	0.037	0.032	0	0	0	0	0	0
Chile	0	0	0	0	0	0	0	0	0.336	0.293
Iceland	0	0	0	0	0	0	0	0	0.161	0.053
Belgium	0	0	0	0	0	0	0	0	0.058	0.051
World total	718.241	809.333	819.000	883.983	928.504	823.45	944.565	793.08	654.662	565.792

The Regulatory Flexibility Act requires that agencies consider the economic impact of their rules on small entities. We expect the impact of this rule for businesses large and small to be insignificant, but note here that the main industries that could be affected—meat processing (NAICS 311612) and meat and meat product merchant wholesalers (NAICS 424470)—are primarily composed of small entities. Under Small Business Administration (SBA) standards, meat processing establishments with no more than 500 employees and meat and meat product wholesalers with no more than 100 employees are considered small. In 2002, there were 1,335 companies in the United States that processed and sold meat. More than 97 percent of these establishments are considered to be small entities and had average sales of $15.4 million, while large meat processors had average sales of $188 million. In 2002, there were 2,535 meat and meat product wholesalers in the United States. Of these establishments, 2,456 (97 percent) employed not more than 100 employees and are, thus, considered small by SBA standards. Small wholesalers had average sales of $9.3 million, while large entities had average sales of $131 million.^[4]

Additionally, entities that produce hogs and pigs (NAICS 112210) could also be affected.^[5] There were 82,028 such farms with sales of hogs. About 94 percent of these farms are considered to be small. The majority of entities that could be affected by the proposed changes would be small entities. The magnitude of impact would depend on the extent of an increase in U.S. trade with regions affected with CSF, especially with Mexico.

As indicated above, the rule would allow uncooked pork and pork products that originate in the United States to be shipped for processing to Mexico, which contains areas where CSF is considered to exist, and then be returned to the United States. As the Mexican Government and U.S. pork producers are the entities that have requested this proposed rule, this trade may increase under the proposed rule, but we are unable to predict the size of the increase. Pork imports from Mexico accounted only for 0.45 percent (in terms of value and only 0.29 percent in terms of volume) of total imports in 2005.

To illustrate the very small impact that the rule is expected to have on the U.S. economy, we estimate that a doubling of pork imports from Mexico in 2005 (including products that originate in the United States), that is, an increase from 2.29 million pounds to 4.58 million pounds, would result in our domestic production of pork declining by only 0.013 percent and the quantity demanded increasing by only 0.011 percent. The estimated quantity changes, as well as the insignificant price effect and the welfare impacts, are shown in Table 2. We estimate in this example that the annual net welfare gain of this outcome of the rule for the United States would equal about $92,000.

Table 2.—The Estimated Impact on the U.S. Economy of Pork Imports From Mexico Doubling From Their 2005 Level of 2.29 Million Pounds

Assumed pork imports, million pounds	4.58
Change in U.S. consumption, million pounds	2.183
Change in U.S. production, million pounds	−2.397
Change in wholesale price of pork, dollars per pound	$0.000086
Change in consumer welfare	$1,650,000
Change in producer welfare	−$1,558,000
Annual net welfare gain	$92,000

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. APHIS-2006-0186. Please send a copy of your comments to: (1) Docket No. APHIS-2006-0186, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 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.

This proposed rule would allow the importation of uncooked pork and pork products from regions where CSF is considered to exist provided the uncooked pork and pork products originate in a region free of CSF and meet certain other conditions with respect to processing and shipping. Allowing such importations will necessitate the use of several information collection activities, including certificates, compliance agreements, cooperative service agreements, and recordkeeping requirements. These information collection activities would aid in our efforts to ensure that uncooked pork and pork products processed in regions where CSF exists do not pose a disease incursion threat when imported into the United States.

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 0.5 hour per response.

Respondents: Federal animal health authorities in Mexico.

Estimated annual number of respondents: 5.

Estimated annual number of responses per respondent: 50.

Estimated annual number of responses: 250.

Estimated total annual burden on respondents: 30 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 [phone].

E-Government Act Compliance

The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at [phone].

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, CLASSICAL SWINE FEVER, 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, 7781-7786, and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

2. In 94.9, a new paragraph (e) would be added to read as follows:

§ 94.9

Pork and pork products from regions where classical swine fever exists.

* * * * *

(e) Uncooked pork or pork products that originated in a region considered to be free of classical swine fever (CSF) and are processed in a region where CSF exists may be imported into the United States under the following conditions:

(1) Shipment to approved establishments. (i) The uncooked pork or pork products must be shipped from the CSF-free region of origin in closed containers sealed with serially numbered seals applied by an official of the national government of that region. They must be accompanied by a certificate that is signed by an official of that region's national government and that specifies the product's region of origin, the name and number of the establishment of origin, and the processing establishment to which the uncooked pork or pork products are consigned, and the numbers of the seals applied to the shipping containers.

(ii) The uncooked pork or pork products may be removed from containers at the processing establishment in the region where CSF is considered to exist only after an official of that region's national government has determined that the seals are intact and free of any evidence of tampering.

(2) Handling of uncooked pork and pork products. Establishments ^[12] in regions where CSF is considered to exist that process uncooked pork or pork products for export to the United States:

(i) May not receive or handle any live swine;

(ii) May not receive, handle, or process uncooked pork or pork products that originate in regions affected with CSF;

(iii) Must keep the certificate required by paragraph (e)(1)(i) of this section on file at the facility for a period of at least 2 years after export of processed products to the United States, and must make those records available to USDA inspectors during inspections; and

(iv) Must be evaluated and approved by APHIS through a site inspection.

(3) Compliance agreement. The operators of the processing establishment must sign a compliance agreement with APHIS, stating that:

(i) All meat processed for importation to the United States will be processed in accordance with the requirements of this part; and

(ii) A full-time, salaried meat inspection official of the national government of the region in which the processing facility is located will supervise the processing and examination of the product, and certify that it has been processed in accordance with this section; and

(iii) APHIS personnel or other persons authorized by the Administrator may enter the establishment, unannounced, to inspect the establishment and its records.

(4) Cooperative service agreement. The processing establishment, or a party on its behalf, must enter into a cooperative service agreement with APHIS to pay all expenses incurred by APHIS for the initial evaluation of the processing establishment and periodically thereafter, including travel, salary, subsistence, administrative overhead, and other incidental expenses, including excess baggage up to 150 pounds. In accordance with the terms of the cooperative service agreement, before the APHIS representative's site inspection, the operator of the processing establishment or the party acting on their behalf must deposit with the Administrator an amount equal to the approximate cost of one inspection by an APHIS, including travel, salary, subsistence, administrative overhead, and other incidental expenses, including excess baggage up to 150 pounds. As funds from that amount are obligated, a bill for costs incurred based on official accounting records will be issued to restore the deposit to the original level, revised as necessary to allow for inflation or other changes in estimated costs. To be current, bills must be paid within 14 days of receipt.

(5) Shipment to the United States. Uncooked pork or pork products to be imported into the United States must be shipped from the region where they were processed in closed containers sealed with serially numbered seals applied by an official of the national government of that region. The shipments must be accompanied by a certificate signed by an official of the national government of the region where the pork or pork products were processed that lists the numbers of the seals applied and states that all of the conditions of this paragraph (e) have been met. The certificate shall also state that the container seals specified in paragraph (e)(1)(i) and (ii) of this section were found by an official of the region's national government to be intact and free of any evidence of tampering on arrival at the processing establishment in the CSF-affected region. A copy of this certificate must be kept on file at the processing establishment for at least 2 years.

* * * * *

§ 94.12

[Amended]

3. In § 94.12, footnotes 12 and 13 would be redesignated as footnotes 13 and 14, respectively.

§ 94.16

[Amended]

4. In § 94.16, footnote 14 would be redesignated as footnote 15.

§ 94.17

[Amended]

5. Section 94.17 would be amended as follows:

a. Footnotes 15 and 16 would be redesignated as footnotes 16 and 17, respectively.

b. In newly redesignated footnote 17, the words “footnote 15” would be removed and the words “footnote 16” added in their place and the words “§ 94.17(e) of this part” would be removed and the words “paragraph (e) of this section” added in their place.

§ 94.18

[Amended]

6. In § 94.18, footnotes 17 and 18 would be redesignated as footnotes 18 and 19, respectively.

Done in Washington, DC, this 28th day of December 2006.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

Footnotes

1.  This rule covers only the processing of uncooked pork and pork products. Any pork or pork products that are cooked or cured must meet the requirements of § 94.9(c).

2.  NASS/USDA, Meat Animals Production, Disposition, and Income: 2005 Summary, April 2006.

3.  Source: The World Trade Atlas: Global Trade Information Services, Inc., U.S. Edition, September 2006.

4.  U.S. Census Bureau, 2002 Economics Census: Manufacturing—Industries Series and Wholesale Trade-Subject, August 2006.

5.  SBA, Small Business Size Standards matched to North American Industry Classification System, Effective July 31, 2006.

12.  See footnote 9 in § 94.8.