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

The Food Safety and Inspection Service (FSIS) is amending the Federal meat inspection regulations to eliminate the requirements for both ready-to-eat (RTE) and not-ready-to-eat (NRTE) pork and pork products to be treated to destroy trichinae ( Trichinella spiralis ) because the regulations are inconsistent with the Hazard Analysis and Critical Control Point (HACCP) regulations, and because these prescriptive regulations are no longer necessary. FSIS is ending its Trichinella Approved Laboratory Program (TALP program) for the evaluation and approval of non-Federal laboratories that use the pooled sample digestion technique to analyze samples for the presence of trichinae. FSIS is also consolidating the regulations on thermally processed, commercially sterile meat and poultry products ( i.e., canned food products containing meat or poultry).

We are amending the Virus-Serum-Toxin Act regulations concerning records and reports. This change requires veterinary biologics licensees and permittees to record and submit reports concerning adverse events associated with the use of biological products they produce or distribute. The information that must be included in the adverse event reports submitted to the Animal and Plant Health Inspection Service (APHIS) will be provided in separate guidance documents. These records and reports will help ensure that APHIS can provide complete and accurate information to consumers regarding adverse reactions or other problems associated with the use of licensed biological products.

The Food Safety and Inspection Service (FSIS) is proposing to amend the Federal meat inspection regulations by removing the provision requiring the cleaning of hog carcasses before any incision is made preceding evisceration. This provision, although focusing on the presentation of carcass dressing defects, impedes the adoption of more efficient, effective procedures under other regulations to ensure that carcasses and parts are free of contamination. Also, the provision is no longer necessary because other regulations require carcass cleaning, the maintenance of sanitary conditions, and the prevention of hazards reasonably likely to occur in the slaughter process.

We are proposing to amend the regulations regarding the branding of bovines imported into the United States from Mexico. We are taking this action at the request of the Government of Mexico to address issues that have arisen with the branding requirement for these bovines. The changes we are proposing would help prevent inconsistencies in branding that can result in bovines being rejected for import into the United States.

We are amending the regulations concerning communicable diseases of livestock and poultry, interstate transportation and importation of animals (including poultry) and animal products, and permits for biological products to remove references to the animal disease rinderpest. This action reflects recognition by the Animal and Plant Health Inspection Service that rinderpest has been eradicated worldwide, and removes restrictions that are no longer necessary due to eradication of the disease. This action better aligns our regulations with World Organization for Animal Health guidelines for international trade as they pertain to rinderpest.

We are proposing to amend the regulations governing the National Poultry Improvement Plan (NPIP) by updating and clarifying several provisions, including those concerning NPIP participation, voting requirements, testing procedures, and standards. These proposed changes were voted on and approved by the voting delegates at the NPIP's 2016 National Plan Conference.

We are amending the regulations to clarify that the expiration date of a serial or subserial of a veterinary biologic should be computed from the date of the initiation of the first potency test. We are also requiring the expiration dating period (stability) of a product to be confirmed by conducting a real-time stability study with a stability-indicating assay, stability monitoring of products after licensing, and specifying a single standard for determining the expiration date for veterinary biologics

The Food Safety and Inspection Service (FSIS) is proposing to amend the egg products inspection regulations by requiring official plants that process egg products (herein also referred to as “egg products plants” or “plants”) to develop and implement Hazard Analysis and Critical Control Point (HACCP) Systems and Sanitation Standard Operating Procedures (Sanitation SOPs) and to meet other sanitation requirements consistent with the meat and poultry regulations. FSIS is proposing to eliminate those current regulatory provisions that are inconsistent with HACCP, Sanitation SOPs, and the proposed sanitation requirements. FSIS is also proposing to specify in the regulations that official plants are required to process egg products to be edible without additional preparation to achieve food safety. In addition, FSIS is proposing to: Provide for generic approval as part of the prior label approval system for egg products; make changes to labeling requirements for shell eggs consistent with those in the Food and Drug Administration's (FDA's) regulations; require special handling instructions on egg products; eliminate the requirements for prior approval by FSIS of egg products plant drawings, specifications, and equipment; incorporate egg products plants into the coverage of the “Rules of Practice” that the Agency follows when initiating administrative enforcement actions; and change the Agency's interpretation of the requirement for continuous inspection in agency law. FSIS is also announcing that it is seeking public comment on draft guidance designed to help small and very small plants producing egg products to meet the new regulatory requirements being proposed in this rulemaking. Should the rule become final, FSIS intends to finalize this guidance.

The Food Safety and Inspection Service (FSIS) is proposing to amend the Federal meat inspection regulations to establish a new inspection system for market hog slaughter establishments that has been demonstrated to provide public health protection at least equivalent to the existing inspection system. Market hog slaughter establishments that do not choose to operate under the new swine inspection system may continue to operate under their existing inspection system. The Agency is also proposing several changes to the regulations that would affect all establishments that slaughter any swine, regardless of the inspection system under which they operate or the age, size, or class of swine. These proposed changes would allow all swine slaughter establishments to develop sampling plans that are more tailored to their specific operations, and thus be more effective in monitoring their specific process control. These proposed changes also would ensure that before the start of slaughter operations, food-contact surfaces are sanitary and free of enteric pathogens.

We are extending the comment period for our advance notice of proposed rulemaking regarding potential revisions to the licensing requirements under our Animal Welfare Act regulations. This action will allow interested persons additional time to prepare and submit comments.

We are amending the regulations governing the importation of certain animals, meat, and other animal products by allowing, under certain conditions, the importation of bone-in ovine meat from Uruguay. Based on the evidence in a risk assessment that we prepared, we believe that bone-in ovine meat can safely be imported from Uruguay provided certain conditions are met. This final rule will provide for the importation of bone-in ovine meat from Uruguay into the United States, while continuing to protect the United States against the introduction of foot-and-mouth disease.