2015 ss final rule

SUPPORTING STATEMENT - OMB NO. 0579-0414

IMPORTATION OF BEEF FROM A REGION IN BRAZIL

July 2015

A. Justification

1. Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection. Attach a copy of the appropriate section of each statute and regulation mandating or authorizing the collection of information.

The Animal Health Protection Act (AHPA) of 2002 is the primary Federal law governing the protection of animal health. The law gives the Secretary of Agriculture broad authority to detect, control, or eradicate pests or diseases of livestock or poultry. The Secretary may also prohibit or restrict import or export of any animal or related material if necessary to prevent the spread of any livestock or poultry pest or disease.

The AHPA is contained in Title X, Subtitle E, Sections 10401-18 of P.L. 107-171, May 13, 2002, the Farm Security and Rural Investment Act of 2002.

Disease prevention is the most effective method for maintaining a healthy animal population and for enhancing our ability to compete globally in animal and animal product trade.

As part of this mission, the Animal and Plant Health Inspection Service (APHIS) regulates the importation of animals and animal products into the United States to guard against the introduction of various animal diseases, including foot-and-mouth disease (FMD). FMD is a dangerous and destructive communicable disease of ruminants and swine which is not currently present in the United States.

APHIS restricts imports of beef and beef products from a region in Brazil composed of the States of Bahia, Distrito Federal, Espirito Santo, Goias, Mato Grosso, Mato Grosso do Sul, Minas Gerais, Parana, Rio Grande do Sul, Rio de Janeiro, Rondonia, Sao Paulo, Sergipe, and Tocantis into the United States under Title 9, Code of Federal Regulations (9 CFR) 94.29. APHIS must collect information (Foreign Meat Inspection Certificate), prepared by an authorized veterinary official of the Government of Brazil, certifying that specific conditions for importation have been met. In order for some of those conditions to be met, APHIS must complete an on-site evaluation and inspection of foreign slaughtering facilities.

APHIS is asking OMB to approve its use of this information collection to ensure that beef and beef products from Brazil pose negligible risk of introducing disease into the United States.

2. Indicate how, by whom, how frequently, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the agency has made of the information received from the current collection.

APHIS will use the Foreign Meat Inspection Certificate and the On-site Evaluation and Inspection of Facilities to ensure that beef and beef products from Brazil pose negligible risk of introducing disease into the United States.

Foreign Meat Inspection Certificate (foreign government)

Imported beef from the specific regions in Brazil must be accompanied by a foreign meat inspection certificate that is completed and signed by an authorized veterinary official of the Brazilian Government to ensure that the beef and beef products are safe for importation.

The certificate must verify:

• The meat is beef from bovines that have been born, raised, and slaughtered in the specific proposed region of Brazil.

• FMD has not been diagnosed in the specific proposed region of Brazil within the previous 12 months.

• The beef came from bovines that originated from premises where FMD has not been present during the lifetime of any bovines slaughtered for the export of beef to the United States.

• The beef came from bovines that were moved directly from the premises of origin to the slaughtering establishment without any contact with other animals.

• The beef came from bovines that received antemortem and postmortem veterinary inspections, paying particular attention to the head and feet, at the slaughtering establishment, with no evidence found of vesicular disease.

• The beef consists only of bovine parts that are, by standard practice, part of the animal’s carcass that is placed in a chiller for maturation after slaughter. Bovine parts that may not be imported include all parts of bovine heads, feet, hump, hooves, and internal organs.

• All bone and visually identifiable blood clots and lymphoid tissue have been removed from the beef.

• The beef has not been in contact with meat from regions other than those listed in
  9 CFR 94.1(a)(2).

• The beef came from bovine carcasses that were allowed to maturate at 40 to 50˚F
  (4 to 10˚C) for a minimum of 36 hours after slaughter and that reached a pH of 5.8 or less in the loin muscle at the end of the maturation period. Measurements for pH must be taken at the middle of both longissimus dorsi muscles. Any carcass in which the pH does not reach 5.8 or less may be allowed to maturate an additional 24 hours and be retested, and if the carcass still has not reached a pH of 5.8 or less after 60 hours, the meat from the carcass may not be exported to the United States.

On-Site Evaluation and Inspection (and recordkeeping) (Business)

To verify that facilities processing beef and beef products from Brazil are following the procedures necessary to lead to the results listed in the Foreign Meat Inspection Certificate, APHIS requires the establishment in which bovines (and sheep) are slaughtered to allow periodic on-site evaluation and subsequent inspection of their facilities, records, and operations by an APHIS representative. Facility personnel must participate in the evaluation and inspection which include, but are not limited to, supplying necessary records.

3. Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also, describe any consideration of using information technology to reduce burden.

The foreign meat inspection certificate must physically accompany the shipment and requires an original signature from the authorizing veterinarian to be valid. Thus, it is not a candidate for electronic submission at this time. However, these certificates are included in the governmentwide utilization of the International Trade Data System (ITDS) via the Automated Commercial Environment (ACE) to improve business operations and further Agency missions.

The evaluation and inspection physically take place at facilities and is therefore not a candidate for electronic submission.

Facilities may use electronic recordkeeping systems.

4. Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purpose described in item 2 above.

The information APHIS collects in connection with this program is not available from any other source. APHIS is the only Agency responsible for preventing the introduction of exotic animal diseases into the United States.

5. If the collection of information impacts small businesses or other small entities, describe any methods used to minimize burden.

The information APHIS collects is the absolute minimum needed to effectively evaluate FMD and other disease risk associated with beef and beef products imported from Brazil. The respondents of this information collection are not considered “small entities” for purposes of Executive Order 12866 or the Regulatory Flexibility Act.

6. Describe the consequence to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.

If the information was collected less frequently or not collected, APHIS would be unable to establish an effective defense against the entry and spread of disease from beef and beef products imported from Brazil. This would cause serious health consequences for U.S. livestock and economic consequences for the U.S. livestock industry.

7. Explain any special circumstances that require the collection to be conducted in a manner inconsistent with the general information collection guidelines in 5 CFR 1320.5.

• requiring respondents to report information to the agency more often than quarterly;

• requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it;

• requiring respondents to submit more than an original and two copies of any docu­ment;

• requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records for more than 3 years;

• in connection with a statistical survey, that is not designed to produce valid and reliable results that can be generalized to the universe of study;

• requiring the use of a statistical data classification that has not been reviewed and approved by OMB;

• that includes a pledge of confidentiality that is not supported by authority estab­lished in statute or regulation, that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or

• requiring respondents to submit proprietary trade secret, or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.

There are no special circumstances associated with this information collection. This information collection is conducted in a manner consistent with the guidelines established in 5 CFR 1320.5.

8. Describe efforts to consult with persons outside the agency to obtain their views on the availability of data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting form, and on the data elements to be recorded, disclosed, or reported. If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the agency's notice, soliciting comments on the information collection prior to submission to OMB.

APHIS spoke to the following individuals concerning the information collection activities associated with this program/information collection:

Laurie Bryant

Meat Importers Council of America, Inc.

1901 Fort Myers Drive, Suite 1110

Arlington, VA 22209

703-522-1910

Pat Gurrentz

Gurrentz International Corporation

2020 Ardmore Boulevard

Pittsburgh, PA 15221

412-351-3200

Steve Sanger

Orleans International, Inc.

30600 Northwestern Highway

Suite 300

Farmington Hills, MI 48334

248-855-5556

APHIS published a proposed rule in the Federal Register (09-017-1) on December 23, 2013 which included a 60-day comment period. That 60-day comment period was reopened and extended on February 27, 2014 taking comments in until April 22, 2014. During the combined comment period, APHIS received 870 comments from producers, trade associations, veterinarians, representatives of State and foreign governments, and individuals. Please see the link below to view all of the comments received from the 60+ day comment period. Many of the comments were in regards to FMD and its contagious nature, but APHIS completed a risk assessment which included FMD and found it to be safe to import beef from a region in Brazil as long as the outlined safety precautions have been met. In addition, all of the comments received and APHIS’ response are discussed in more detail, by topic, in the Final Rule which APHIS published in Federal Register on July 2, 2015.

http://www.regulations.gov/#!searchResults;rpp=25;po=825;s=aphis-2009-0017;dct=FR%252BPR%252BN%252BO%252BPS

9. Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.

This information collection activity involves no payments or gifts to respondents.

10. Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy.

No additional assurance of confidentiality is provided with this information collection. However, the confidentiality of information is protected under 5 U.S.C. 552a.

11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior or attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.

This information collection activity will ask no questions of a personal or sensitive nature.

12. Provide estimates of the hour burden of the collection of information. Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated.

• Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens in Item 13 of OMB Form 83-I.

See APHIS Form 71. Burden estimates were developed from discussions with Brazilian Federal animal health authorities who will complete the certificate necessary to export beef that may pose a risk of introducing FMD to the United States, as well as with managers of facilities preparing the beef for export.

• Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories.

Respondents are authorized veterinary officials employed by the Government of Brazil and export facility managers. APHIS estimates the total annualized cost to these respondents to be $60,192. APHIS arrived at this figure by multiplying the total burden hours (1,629) by the estimated average hourly wage of the above respondents ($36.95).

The hourly rate for Brazilian Federal veterinarians ($20) was determined through discussions with international contacts based in Brazil. Industry contacts provided the hourly wage of managers of foreign facilities that process animal products in Brazil to be $53.89. APHIS then averaged the two wages to get $36.95.

13. Provide estimates of the total annual cost burden to respondents or recordkeepers resulting from the collection of information (do not include the cost of any hour burden shown in items 12 and 14). The cost estimates should be split into two components: (a) a total capital and start-up cost component annualized over its expected useful life; and (b) a total operation and maintenance and purchase of services component.

No annual cost burden is associated with capital and startup costs, operation and maintenance expenditures, and purchase of services.

14. Provide estimates of annualized cost to the Federal government. Provide a description of the method used to estimate cost and any other expense that would not have been incurred without this collection of information.

The annualized cost to the Federal government is estimated at $90,192. (See APHIS Form 79.)

15. Explain the reasons for any program changes or adjustments reported in Items 13 or 14 of the OMB Form 83-1.

• ICR Summary of Burden:

• 

	Requested	Program Change Due to New Statute	Program Change Due to Agency Discretion	Change Due to Adjustment in Agency Estimate	Change Due to Potential Violation of the PRA	Previously Approved
Annual Number of Responses	1,773	0	1,773	0	0	0
Annual Time Burden (Hr)	1,629	0	1,629	0	0	0
Annual Cost Burden ($)	0	0	0	0	0	0

This is a new information collection resulting 1,773 responses and 1,629 total burden hours to allow for the safe importation of beef and beef products from a region in Brazil.

16. For collections of information whose results are planned to be published, outline plans for tabulation and publication.

APHIS has no plans to publish the information it collects in connection with this program.

17. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.

There are no APHIS forms associated with this information collection.

18. Explain each exception to the certification statement identified in the "Certification for Paperwork Reduction Act."

APHIS can certify compliance with all provisions in the Act.

B. Collections of Information Employing Statistical Methods

Statistical methods are not employed in this information collection activity.