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«REPORT OF THE COMMITTEE ON IMPORT-EXPORT Chair: Mark Engle, TN Vice Chair: Robert Blomme, IA Bobby Acord, NC; Debbie Barr, ON; Robert Blomme, IA; Bob ...»

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REPORT OF THE COMMITTEE ON IMPORT-EXPORT

Chair: Mark Engle, TN

Vice Chair: Robert Blomme, IA

Bobby Acord, NC; Debbie Barr, ON; Robert Blomme, IA; Bob Bokma, MD; Joyce Bowling-Heyward, MD;

Gary Brickler, CA; Charles Brown II, WI; Stan Bruntz, CO; Jess Burner, TX; Ignacio dela Cruz, MP; Larry

Elsken, IA; Effingham Embree, Jr., IL; Mark Engle, TN; J Amelita Facchiano, TX; William Fales, MO;

Mallory Gaines, DC; Julie Gard, AL; Paul Gibbs, FL; Chester Gipson, MD; Tony Good, OH; Cathleen Hanlon, GA; Percy Hawkes, UT; Rick Hill, IA; Robert Hilsenroth, FL; Donald Hoenig, ME; Floyd Horn, MD;

Laurie Hueneke, DC; Annette Jones, CA; Elizabeth Lautner, IA; R.J. Layher, DC; Kevin Maher, IA;

Brittany McCauslin, CO; Susan McClanahan, MN; David Meeker, VA; Gay Miller, IL; Richard Mitchell, CT;

Sandra Norman, IN; Elizabeth Parker, TX; James Pearson, IA; Alejandro Perera, MEX; William Pittenger, MO; Herbert Richards, HI; Paul Rodgers, WV; Larry Samples, PA; A. David Scarfe, IL; Travis Schaal, IA;

Shawn Schafer, OH; Kathryn Simmons, DC; Peter Timoney, KY; Alberto Torres, AR; Charles Vail, CO;

Arnaldo Vaquer, VA; Mark Walter, PA; James Watson, MS; Patrick Webb, IA; Roger Weigle, WI; Brad Williams, TX; Mary Anne Williams, TX; William Wilson, KS; David Winters, TX; Richard Winters, Jr., TX;

Cindy Wolf, MN.

The Committee met on 10/19/2014 at the Sheraton Hotel in Kansas City, Missouri, from 12:30 PM to 5:00 PM. There were 22 members and 17 guests present. Dr. Blomme called the Committee to order and welcomed participants. The committee purpose, membership, meeting, and resolution guidelines were reviewed. There were no previous resolutions.

Time-Specific Paper Title.

No time specific papers were presented.

Presentations & Reports NIES Import of Animal Products and By-Products Tracye R (Butler) Hernandez-Bynum USDA APHIS VS NIES Dr. Butler provided an overview of NIES activities related to import of animal products. A detailed report is included below Products Trade Negotiations Staff FY 2014 Activities Tracye R (Butler) Hernandez-Bynum USDA APHIS VS NIES Dr. Butler provided an overview of staff activities related to exports of animal products. A detailed report is included below Import-Export Update FY 2014 Joyce Bowling-Heyward, USDA APHIS VS NIES Dr. Bowling-Heyward provided an overview of FY 2014 export and import activities including employee training for the Veterinary Export Health Certification System (VEHCS), semen and embryo facilities inspection, and certificate endorsement. Other focused activities included talks with Canada and Mexico on the acceptance of electronic signatures, expanding exports for live cattle, providing technical expertise to stakeholders, technical support for visiting foreign veterinarians and responding to trade disruptions in live swine for PEDv. Dr. Bowling-Heyward provided overviewed VEHCS system which is designed to be a standard globally accepted export health certificate system with a database for analytics and reporting.

Recent updates to the system include digital signatures, external web viewer and a universal health certificate in English. The next step is to work towards WTO notification to alert trading partners, expand acceptance of the digital signature with partner countries, development of a universal Spanish certificate and full implementation of the system across the United States.

INTERIM REPORT

Fiscal year 2014 import activities included approval of several privately owned equine quarantine facilities, renovation of a USDA bird quarantine facility in San Ysidro and construction of import inspection facilities at various Mexican border port locations. Staff continue to work with Mexico on joint tuberculosis strategic planning activities. Improvements are being made to the import tracking system to improve collection and trace back of animal identification. Staff participated in Northern Border Port Conference, Air and Sea Port Conference, and Animal Import Center Conference to review policies and improve consistency at import and port facilities. Import staff continue to issue important transit permits, provide technical expertise, negotiate import protocols, provide training at the field level and responding to questions from importers and foreign governments. Animal import numbers were provided for porcine, ovine, bison, equine, avian and bovine and swine semen in FY 2014.

Vision and Science: National Import Export Services (NIES) Joyce Bowling-Heyward, USDA APHIS VS NIES Dr. Bowling-Heyward provided an overview of the recent reorganization of the National Import Export Services which included the vision and mission statements, key services of the agency, the organizational chart, and fiscal year 2014 priorities related to operations, customer service, IT strategies and workplace culture.

Entry Assessment for Exotic Viral Pathogens of Swine Kelly Rhodes, USDA APHIS VS NIES Dr. Rhodes provided an overview the entry assessment for exotic viral pathogens of swine. She reviewed the objectives of the assessment which were to identify and describe pathways by which exotic viral pathogens of swine may enter the United States and estimate the likelihood that each identified pathway may introduce exotic pathogens of swine into the United States. The assessment included hazard identification, entry assessment methods, risk estimation terms, uncertainty terms, assumptions, pathway groups and feed ingredient origins. The assessment used Foot and Mouth Disease, Pseudorabies and Classical Swine Fever as representative viruses and identified negligible risk pathways for animal tissues or fluids, articles, animal feeds, animal tissues and fluids and other articles, animal feed and human food.





The assessment also identified non-negligible risk pathways for animal feeding and human food. The next steps for this process is to look at pathways with non-negligible likelihood of introduction and estimate the likelihood of exposure, and evaluate the consequences. In regards to pathways where risk introduction and overall exposure are non-negligible the goal would be to identify potential mitigation measures.

Importation of Fetal Bovine Serum Percy W. Hawkes, Independent Consultant for Biowest Dr. Hawkes provided an overview of a request that USDA APHIS VS update and publish a proposed rule for importing fetal bovine serum. The overview included an overview of the world supply for fetal bovine serum, identified suppliers and their capacity, and international trade statistics. A background was provided on the USDA and industry efforts to update FBS import requirements. Dr. Hawkes also reviewed five points for consideration when updating importation requirements. Those five points are included in a resolution submitted by Dr. Hawkes for committee consideration.

Committee Business:

Three proposed resolutions relating to African swine fever, fetal bovine serum, and bluetongue were submitted to the committee for consideration. The committee reviewed and discussed each proposed

resolution and the following resolutions were passed:

RESOLUTION: IMPORTATION OF FETAL BOVINE SERUM

PASSED 5 Aye / 4 Ney The United States Animal Health Association (USAHA) urges the United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS) to publish the proposed rule authorizing the use of gamma irradiation for the importation of commercial shipments of

INTERIM REPORT

Fetal Bovine Serum (FBS) from countries and/or regions that have restrictions because of pathogens that can be eliminated by gamma irradiation, thus helping assure a reliable, affordable, safe and continuous supply of pathogen-free FBS to research laboratories and biologics manufacturers.

The Committee also urges USDA, APHIS, VS to work with the FBS industry to include the following options when updating FBS import requirements: 1) Irradiation outside the US with proper USDA oversight, 2) Importation of irradiated FBS from FMD free countries with vaccination, 3) Processing of FBS in 3rd countries with proper USDA oversight, 4) Safety testing of FBS using internationally accepted tests other than animal inoculation, and 5) Define penalties for fraud and misrepresentation.

RESOLUTION: Need for APHIS Risk Assessment and Rulemaking prior to Allowing Imports from Countries with African Swine Fever PASSED: Unanimously The United States Animal Health Association requests that USDA APHIS conduct a risk assessment for any country that has ASF in either the domestic herd or feral swine that currently imports or seeks to import swine, porcine genetic material, pork or pork products into the U.S. APHIS shall use such a risk assessment as the basis for independent rulemaking, not amendment of current regulations that pertain to other FADs, which includes a proposed rule and a comment period. Only after such rulemaking and consideration of comments should imports be considered. If during rulemaking APHIS recommends development of an ASF Free Compartment within such a country, it is requested that producers in such a compartment be required to follow and document the same biosecurity practices as would U.S. producers in the case of an ASF outbreak. These biosecurity practices are outlined in the Secure Pork Supply (http://www.securepork.org/plan-components.php).

RESOLUTION: Bluetounge, National Strategy for Animal ExportsPASSED: Unanimously

Given the historic and ongoing negative impact of endemic bluetongue virus infection to the export of ruminant livestock from the United States, the United States Animal Health Association (USAHA) requests that the United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS), develop, educate and facilitate a national strategy for animal exports, possibly through regionalization supported by a national surveillance program as prescribed by OIE (Terrestrial Animal Health Code chapter 8.3).

Addendums to the committee report should be in the following order:

Subcommittee Reports Time-Specific Papers Other Presentations/Papers Supplemental information

OTHER NOTES:

–  –  –

Presented by Tracye (Butler) Hernandez-Bynum Import Animal Products National Import Export Services (NIES) continues its mission to facilitate safe international trade of animal products and by-products, regulate the importation of animal products and by-products, prevent the introduction of dangerous and costly pests and diseases, promulgate import regulations and policies, collaborate with other government agencies and issue import permits. During FY14, NIES issued a total of 4725 permits for animal products, as well as Organisms and Vectors.

NIES is continuing is to work on streamlining animal product import regulations provided in Title 9, Code of Federal Regulations, Parts 94, 95 and 96. This streamlining process will reorganize, clarify and update the regulations for easier understanding. It will also provide for a notice-based process and risk-based criteria for acceptance of new disease mitigation procedures. These new mitigation procedures will be posted on our website and the mitigation requirements will be less prescriptive.

Bovine Spongiform Encephalopathy (BSE) Comprehensive Rule

The BSE Comprehensive Rule was finalized December 2013; and became effective March 4, 2014. It established BSE-related import provisions more closely aligned with OIE guidelines including country risk status classifications (Negligible, Controlled, and Undetermined). It also allows flexibility in the BSE risk classification process allowing APHIS to concur with OIE BSE determinations after APHIS has evaluated a country or region’s BSE status. All countries will be considered undetermined risk until such time that APHIS determines them to be Negligible or Controlled Risk. Recognition will be based on the following criteria;

(1) APHIS concurrence with OIE classification, OR (2) APHIS evaluation, upon request, of countries not classified by the OIE The BSE Comprehensive Rule eliminates the need for formal rulemaking for each individual country/region. The importation of bovines and bovine products from BSE minimal-risk regions (Canada) and for boneless beef from Japan have been removed from the Federal Register and incorporated into the final rule. It allows the importation of additional bovine and bovine products into the United States

from the 3 risk category countries under certain conditions. The bovine products include:

(1) Hides/skins and Gelatin/Collagen from hides/skins (2) Deboned meat (excluding MSM) from cattle ≤30 months of age provided the animals pass ante- and post-mortem inspection, specified risk materials (SRM) are removed, and they were not subjected to an air injected stunning process or pithing (3) Protein-free tallow and derivatives made from this tallow (4) Dicalcium phosphate with no trace of protein or fat (5) Blood/blood by-products derived from cattle not subjected to an air injected stunning process or pithing, and collected in a manner that avoids contamination Ruminant meat-and-bone meal (MBM) and greaves from controlled and undetermined risk countries will remain as prohibited materials.

APHIS Concurs with OIE Designations On October 1, 2014, APHIS published it’s concurrence with OIE’s BSE risk designations for the following

countries:

–  –  –

Transmissible Spongiform Encephalopathies (TSE) Rule OIE Code does not address BSE risk for ovines/caprines. Therefore, a separate rule is currently under development that will address import requirements for TSEs and allow importation of sheep and goats, their embryos, and their products/by products from countries classified as Negligible or Controlled Risk for BSE under certain conditions. This rule is currently undergoing Departmental clearance. The importation of sheep and goat material will continue to be regulated under the BSE conditions that existed prior to implementation of the new BSE Comprehensive rule until the TSE rule is finalized.



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