E-icr Asf Pr Usvi Ss (20211129)

E-ICR ASF PR USVI SS (20211129).docx

Control of African Swine Fever; Restrictions on the Movement of Swine Products and Swine Byproducts from Puerto Rico and the U.S. Virgin Islands

OMB: 0579-0480

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November 2021


Supporting Statement

Control of African Swine Fever; Specified Conditions on the Movement

of Certain Swine Products and Swine Byproducts

from Puerto Rico and the U.S. Virgin Islands

OMB Control No. 0579-XXXX


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 required 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; 7 U.S.C. 8301, et. seq. The pertinent sections of 7 U.S.C 8301 et. seq. are 7 U.S.C. 8303(a)(1) (general restriction on importation or entry of animals or related material, cited above), and 7 U.S.C. 8305, which gives the Secretary authority to prohibit or restrict the movement in interstate commerce of any animal, article, or means of conveyance if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction or dissemination of any pest or disease of livestock. The statute defines “interstate commerce” as “trade, traffic, or other commerce (A) between a place in a State and a place in another State, or between places within the same State but through any place outside that State; or (B) within the District of Columbia or any territory or possession of the United States.” The statute further defines “State” as including the Commonwealth of Puerto Rico and the Virgin Islands of the United States.


Part of the mission of the Veterinary Services (VS) business unit of the Animal and Plant Health Inspection Service (APHIS) is preventing foreign animal disease outbreaks in the United States, and monitoring, controlling, and eliminating a disease outbreak should one occur. In the past several years, there have been significant worldwide outbreaks of African swine fever (ASF). ASF is a highly contagious and deadly viral disease affecting both domestic and feral (wild) pigs. The disease has not been detected in the United States; however, USDA is committed to working with State and industry partners to keep the virus out of the country.


The Dominican Republic is currently reporting a significant outbreak of ASF. While ASF is not known to occur in Puerto Rico or the U.S, Virgin Islands, these areas are close to the Dominican Republic. Frequent passenger travel and international mail shipments occur between the Dominican Republic and Puerto Rico and the U.S. Virgin Islands, as well as frequent small-scale commercial agricultural trade. Thus, APHIS has identified several pathways for the possible introduction of ASF from the Dominican Republic to Puerto Rico or the U.S. Virgin Islands. Moreover, there are known commercial and feral pig populations in both territories, and there are currently no restrictions on the interstate movement of live swine, swine germplasm, swine products, and swine byproducts from Puerto Rico or the U.S. Virgin Islands into the continental United States. Accordingly, APHIS is moving to restrict interstate movement of live swine, swine germplasm, and processed swine products and byproducts through issuance of a Federal Order. In situations where a disease risk is sufficiently severe and fast-moving so that the regular regulatory process cannot provide adequate relief, APHIS employs Federal Orders to set trade restrictions quickly to control, eradicate, or prevent a disease threat.


APHIS is requesting the Office of Management and Budget (OMB) approve, for an initial 6-month emergency period, its use of transport permit documents to verify compliance with the Federal Order’s requirements for transporting swine products and byproducts from Puerto Rico and the U.S. Virgin Islands.



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.


Application for Permit to Transport Swine Products and/or Byproducts (VS 16-3 or equivalent supporting documentation); (Federal Order, 9 CFR 94.8); (Business, State)

Producers seeking to transport swine products and/or byproducts from Puerto Rico and the U.S. Virgin Islands to another State, Territory, or the District of Columbia must submit documentation verifying that the products were treated according to APHIS requirements as set forth below:


  • The products or byproducts were fully cooked by a commercial method in a container hermetically sealed promptly after filling but before such cooking, so that such cooking and sealing produced a fully sterilized product which is shelf-stable without refrigeration; or

  • The products or byproducts were heated by other than a flash-heating method to an internal temperature of at least 69 °C. (156 °F.) throughout after the bones had been removed.


Pork rind pellets (pork skins) must be cooked in one of the following ways in an establishment that meets APHIS regulatory requirements:


  • One-step process. The pork skins must be cooked in oil for at least 80 minutes when oil temperature is consistently maintained at a minimum of 114 °C.

  • Two-step process. The pork skins must be dry cooked at a minimum of 260 °C for approximately 210 minutes after which they must be cooked in hot oil (deep-fried) at a minimum of 104 °C for an additional 150 minutes.


If the producer does not have such documentation, he or she must submit an application form (VS 16-3) in writing to APHIS for permission to transport swine products and/or byproducts from Puerto Rico and the U.S. Virgin Islands to another State, Territory, or the District of Columbia. In addition to the certifications described above, the application must contain the importer’s name, address, telephone number, fax number, a description of the products to be imported, the quantity and frequency of importation, the proposed use of the products, and a description of the applicant’s facilities for handling the products. This information enables APHIS to scrutinize the products and determine what, if any, disease threat they may pose to the U.S. livestock population. If APHIS decides to issue a transport permit, information on the VS 16-3 enables officials to determine the appropriate safeguarding measures for the transport. APHIS can then provide port personnel with appropriate clearance instructions.



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 VS Form 16-3 may be downloaded as a fillable PDF from the APHIS electronic form library at https://www.aphis.usda.gov/library/forms/pdf/VS_16_3.pdf and submitted electronically, or it may be completed and submitted via eFile and the VS Permitting Assistant.



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 effort is not available from any other source. APHIS is the only Federal agency responsible for preventing, detecting, controlling, and eliminating foreign animal diseases from the United States.



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


APHIS estimates approximately 35 percent of the respondents in this information collection are small businesses. The information collected is the absolute minimum needed to prevent the spread of ASF.



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 were conducted less frequently or not at all, APHIS would not be able to adequately protect producers and herd owners against the incursion of ASF. A lack of this information could undermine APHIS’ ability to prevent an outbreak which may result in additional disease spread and greater producer hardship.



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, such as:

  • 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.


No special circumstances exist that would require this collection to be conducted in a manner inconsistent with the general information collection guidelines 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 has engaged in productive consultations with the following individuals to discuss this information collection. They were contacted by email and phone to discuss the information APHIS collects to administer its new import requirements. We discussed with them how we and they obtain the necessary data and how frequently; how much data is available; the convenience and clarity of reporting formats and other collection instruments; and the clarity of, and necessity for, any recordkeeping requirements. The respondents stated via email or phone that they had no concerns with any of these items and had no further recommendations.

Dr. Liz Wagstrom

Chief Veterinarian, National Pork Producers Council

122 C Street NW, Suite 875

Washington, D.C. 20001

Tel. (202) 347-3600

[email protected]


Mitch Christensen

Chief Veterinary Officer, Topigs Norsvin USA

12750 Nicollet Ave South, Suite 300

Burnsville, Minnesota 55337

Tel. (952) 641-0220


Dr. Lisa Becton

Director, Swine Health Information and Research,

National Pork Board

1776 NW 114th St

Des Moines, IA 50325

Tel. (515) 223-2600

[email protected]



9. Explain any decision to provide any payment or gift to respondents, other than reenumeration 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.



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 for hour burden estimates. Estimates were developed based on real-time use and discussions with animal health officials from Puerto Rico and the U.S. Virgin Islands as well as swine producers and product transporters, as well as estimates from currently existing uses of the form. VS estimated that there are approximately 20 potentially affected producers from Puerto Rico and the U.S. Virgin Islands who would need to use the form VS 16-3 to account for movements of pork and pork products in accordance with the requirements of the Federal Order. VS, using existing uses of the form as a basis, estimated about one response per business respondent, with the two affected States having to process the total number of forms from the producers. Time estimates were adapted from existing similar uses of the VS 16-3.


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


The total annualized cost to respondents is $2,440.41 computed by multiplying the estimated average hourly wage ($28.07) by the total number of burden hours needed to complete the work (60), and then multiplying the product ($1,684.20) by 1.449 to capture benefit costs.


The average hourly rates used to calculate the estimate are for animal health officials (SOCC 45-1011, first-line supervisors of farming, fishing, and forestry workers, $26.16), ranchers (SOCC 11-9013, $36.93), and animal breeders (SOCC 45-2021, $21.12), using information found at the U.S. DOL Bureau of Labor Statistics occupational employment statistics website at http://www.bls.gov/current/oes_stru.htm.


According to DOL BLS news release USDL-21-0437 released March 18, 2021, employee benefits account for 31 percent of employee costs, and wages account for the remaining 69 percent. Mathematically, total costs can be calculated as a function of wages using a multiplier of 1.449.









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.


See APHIS 79. The annualized cost to the Federal government is estimated at $1,915.



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


This is a new collection.



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


APHIS has no plans to publish 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.


APHIS is requesting exemption for not displaying the expiration date on the VS Form 16-3 because it is used in multiple information collections, each with a different approval expiration date.



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


APHIS can certify compliance with all provisions under the Act.



B. Collections of Information Employing Statistical Methods


There are no statistical methods associated with the information collection activities used in this program.

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