9 CFR Chapter I - ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE

In a final rule that was published in the Federal Register on November 10, 2014, and effective on December 10, 2014, we adopted, with changes, an interim rule that amended the brucellosis regulations to, among other things, reduce the age at which most cattle and domestic bison are included in herd blood tests. In that amendment we intended to include all sexually intact cattle and domestic bison 18 months of age or older in herd blood tests, however we inadvertently omitted the words “or older.” This document corrects that error.

We are withdrawing an interim rule that established regulations to restrict the interstate movement and importation into the United States of live fish that are susceptible to viral hemorrhagic septicemia, a highly contagious disease of certain fresh and saltwater fish. We are taking this action after considering the comments we received following the publication of the interim rule, which subsequently delayed the effective date of the interim rule indefinitely.

We are proposing to amend the regulations governing approval of facilities that receive livestock moved in interstate commerce. We are also proposing several amendments to the conditions under which livestock may move to such facilities without official identification or prior issuance of an interstate certificate of veterinary inspection or alternative documentation. These changes are necessary to update the regulations governing livestock marketing facilities, while also helping ensure animal disease traceability of livestock that are moved in interstate commerce to such facilities.

The Food Safety and Inspection Service (FSIS) is amending its regulations to require the use of a descriptive designation as part of the product name on the labels of raw meat and poultry products that contain added solutions and that do not meet a standard of identity. The descriptive designation will have to include the percentage of added solution, and the individual ingredients or multi-ingredient components in the solution listed in descending order of predominance by weight. The print for all words in the product name, including the descriptive designation, must appear in a single easy-to-read type style and color and on a single-color contrasting background. The print may appear in upper and lower case letters, with the lower case letters not smaller than one-third ( 1/3 ) the size of the largest letter. The percent solution must appear as a number ( e.g., 15, 20, 30) with the percentage sign (%) and may be declared with the word “containing” or “contains.” Under this final rule, the word “enhanced” is not allowed in the product name. The Agency is also removing the standard of identity regulation for “ready-to-cook poultry products to which solutions are added”.

In a final rule that was published in the Federal Register on July 9, 2014, and effective on August 8, 2014, we amended the provisions of the National Poultry Improvement Plan by, among other things, amending the standards for the U.S. H5/H7 Avian Influenza Monitored classification. In that amendment, we incorrectly indicated that table-egg layer flocks may qualify for U.S. H5/H7 Avian Influenza Monitored status if they meet one of three testing and surveillance requirements, when we should have indicated such flocks must meet all applicable listed testing and surveillance requirements to qualify. This document corrects that error. We are also making several other minor edits for clarity.

We are adopting as a final rule, with changes, an interim rule that amended the regulations concerning the importation of animals and animal products to prohibit or restrict the importation of live birds and poultry (including hatching eggs) and bird and poultry products from regions where any subtype of highly pathogenic avian influenza (HPAI) is considered to exist. The interim rule also added restrictions concerning importation of live birds and poultry that have been moved through regions where HPAI is considered to exist, or that have been vaccinated for certain types of avian influenza. This final rule amends the interim rule to allow the importation of live zoological birds and poultry that have been vaccinated for avian influenza as part of an official program and under specific conditions as determined by the Administrator and to allow the importation of HPAI-resistant pigeons, doves, and other Columbiform species under certain conditions from regions where HPAI is considered to exist. This action will provide for the importation of certain zoological birds and poultry under specified conditions designed to minimize the risk of introducing HPAI into the United States.

The Food Safety and Inspection Service (FSIS) is amending the meat, poultry, and egg products import regulations to provide for the Agency's Public Health Information System (PHIS) Import Component. The PHIS Import Component, launched on May 29, 2012, provides an electronic alternative to the paper-based import inspection application and the foreign inspection and foreign establishment certificate processes. The Agency is also removing from the regulations the discontinued “streamlined” import inspection procedures for Canadian product and is requiring Sanitation Standard Operating Procedures (SOPs) at official import inspection establishments. In addition to the regulatory amendments outlined above, FSIS is discontinuing its practice of conducting imported product reinspection based on a foreign government's guarantee to replace a lost or incorrect foreign inspection certificate and is clarifying its policy of addressing imported product that is not presented for reinspection.

We are amending the veterinary biological product regulations by defining the terms used for reporting the results of tests performed on veterinary biological products. Licensees and permittees of veterinary biological products must conduct these tests and report the results to the Animal and Plant Health Inspection Service so that the Agency can determine if the products are eligible for release. Defining these terms will clarify the circumstances under which the results of a prescribed test can be reported as satisfactory, unsatisfactory, inconclusive, or a No Test. We are also removing several obsolete testing standard requirements from the regulations. These changes will update our regulations and improve communication between regulators and product licensees and permittees with respect to reporting test results.

The Food Safety and Inspection Service (FSIS) is amending the poultry products inspection regulations to establish a new inspection system for young chicken and all turkey slaughter establishments. Young chicken and turkey slaughter establishments that do not choose to operate under the new poultry inspection system may continue to operate under their current inspection system. The Agency is also making several changes to the regulations that will affect all establishments that slaughter poultry other than ratites. This final rule is a result of the Agency's 2011 regulatory review efforts conducted under Executive Order 13563 on Improving Regulation and Regulatory Review.

We are amending the regulations regarding official tuberculosis tests for captive cervids to remove the CervidTB Stat-Pak® as an official bovine tuberculosis test for the following species of captive cervids: Elk, red deer, white-tailed deer, fallow deer, and reindeer. We are also amending the regulations to specify that the Dual Path Platform (DPP)® test, which was previously a supplemental test to be used in conjunction with the CervidTB Stat-Pak®, is now considered a primary test, as well. We are taking this action because the CervidTB Stat-Pak® is no longer being produced, and because we have determined that the DPP® test can reliably be used as a primary test for bovine tuberculosis in certain species of captive cervids. This action is necessary on an immediate basis so that the regulations do not continue to authorize usage of a discontinued test, yet still provide regulated entities with options in order to meet the testing requirements for captive cervids within the regulations.

We are amending the National Poultry Improvement Plan (NPIP, the Plan) and its auxiliary provisions by removing the descriptions of specific tests and sanitation procedures from the regulations. Instead, we will require tests to be performed and sanitation to be maintained in a manner approved by the Administrator. Approved procedures will be listed in an NPIP Program Standards document, which we are making available on the NPIP Web site. In addition, we are establishing new compartment classifications for defined subpopulations of primary breeding turkeys, primary egg-type chickens, and primary meat-type chickens. We are also providing new or modified sampling and testing procedures for Plan participants and participating flocks. The changes in this final rule were voted on and approved by the voting delegates at the Plan's 2010 and 2012 National Plan Conferences. These changes will streamline the provisions of the Plan, keep those provisions current with changes in the poultry industry, and provide for the use of new sampling and testing procedures.

We are amending the “In vitro tests for serial release” regulations by removing a footnote that refers to one method to calculate the relative antigen content of inactivated veterinary biological products and relative potency calculation software available from Veterinary Services' Center for Veterinary Biologics (CVB). CVB will no longer provide or update the software and the written method for using the software will no longer be used. This action will update the regulations.

We are adopting as a final rule, with two miscellaneous changes, an interim final rule that established a herd certification program to control chronic wasting disease (CWD) in farmed or captive cervids in the United States. The interim final rule specifically requested comment on our policy that our CWD regulations set minimum requirements for the interstate movement of farmed or captive deer, elk, and moose but will not preempt State or local laws or regulations that are more restrictive than our regulations. This document responds to comments we received on that policy. The interim final rule was necessary to help to control the incidence of CWD in farmed or captive cervid herds and prevent its spread.

We are proposing to change the hourly rates charged for Sundays, holidays, or other overtime work performed by employees of the Animal and Plant Health Inspection Service (APHIS) for any person, firm, or corporation having ownership, custody, or control of regulated commodities or articles subject to inspection, laboratory testing, certification, or quarantine under the regulations. We are proposing to increase these overtime rates for each of the fiscal years 2014 through 2018 to reflect the anticipated costs associated with providing these services during each year. Establishing the overtime rate changes in advance would allow users of APHIS' services to incorporate the rates into their budget planning. We are also proposing to clarify the regulations to indicate that agricultural inspections performed by the Department of Homeland Security (DHS) may be billed in accordance with DHS overtime regulations for services performed outside of regular business hours, as DHS rates may differ from those charged by APHIS.

We are proposing to amend the Virus-Serum-Toxin Act regulations to provide for the use of a simpler labeling format that would better communicate product performance to the user. We intend to replace the current label format, which reflects any of four different levels of effectiveness, with a single, uniform label format. We are also proposing to require biologics licensees to provide a standardized summary, with confidential business information removed, of the efficacy and safety data submitted to the Animal and Plant Health Inspection Service in support of the issuance of a full product license or conditional license. A simpler label format along with publicly available safety and efficacy data will help biologics producers to more clearly communicate product performance to their customers.

In a final rule published in the Federal Register on March 29, 2013, and effective on April 15, 2013, we amended the regulations governing the importation of animals and animal products by recognizing 25 Member States of the European Union (EU) as the Animal and Plant Health Inspection Service (APHIS)-defined EU Poultry Trade Region. In that rule, we established requirements for the importation of live birds and poultry, and poultry meat and products, from the APHIS-defined EU Poultry Trade Region. In the final rule, it was not our intent to prohibit the importation of birds, poultry, and poultry meat and products from Member States of the APHIS-defined EU Poultry Trade Region that conduct trade in poultry and poultry products with other regions that APHIS recognizes as being free of Newcastle disease and highly pathogenic avian influenza. It was also not our intent that the import requirements for cooked poultry meat and products from the APHIS-defined EU Poultry Trade Region not be equivalent with the requirements we apply to other regions whenever an outbreak of Newcastle disease or highly pathogenic avian influenza occurs in those regions. This document amends the regulations to reflect our original intentions.

We are proposing to amend the National Poultry Improvement Plan (NPIP, the Plan) and its auxiliary provisions by removing the descriptions of specific tests and sanitation procedures from the regulations. Instead, we would require tests to be performed and sanitation to be maintained in a manner approved by the Administrator. Approved procedures would be listed in an NPIP Program Standards document, which we would make available on the NPIP Web site. In addition, we are proposing to establish new compartment classifications for defined subpopulations of primary breeding turkeys, primary egg-type chickens, and primary meat-type chickens. We would also provide new or modified sampling and testing procedures for Plan participants and participating flocks. The proposed changes were voted on and approved by the voting delegates at the Plan's 2010 and 2012 National Plan Conferences. These changes would streamline the provisions of the Plan, keep those provisions current with changes in the poultry industry, and provide for the use of new sampling and testing procedures.