Title 9 published on 2012-01-01
The following are only the Rules published in the Federal Register after the published date of Title 9.
For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.
In accordance with the Agricultural Bioterrorism Protection Act of 2002, we are amending and republishing the list of select agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or plant products. The Act requires the biennial review and republication of the list of select agents and toxins and the revision of the list as necessary. This action implements the findings of the third biennial review of the list. In addition, we are reorganizing the list of select agents and toxins based on the relative potential of each select agent or toxin to be misused to adversely affect human, plant, or animal health. Such tiering of the list allows for the optimization of security measures for those select agents or toxins that present the greatest risk of deliberate misuse with the most significant potential for mass casualties or devastating effects to the economy, critical infrastructure, or public confidence. We are also making a number of amendments to the regulations, including the addition of definitions and clarification of language concerning security, training, biosafety, biocontainment, and incident response. These changes will increase the usability of the select agent regulations as well as provide for enhanced program oversight.
The Food Safety and Inspection Service (FSIS) is amending the meat and poultry product regulations pertaining to the schedule of operations. FSIS is amending these regulations to define the 8-hour workday as including time that inspection program personnel need to prepare the inspection station, if necessary, or retrieve and return lot tally sheets; the time necessary for FSIS inspection program personnel to sharpen knives, if necessary; and the time necessary to conduct duties scheduled by FSIS, including administrative activities. The activities are integral and indispensable to inspectors' work and are part of the continuous workday as defined by the Fair Labor Standards Act. Therefore, they are activities that need to be part of the Agency's regulatory definition for the 8-hour workday.
We are amending the regulations that govern the importation of animals and animal products by consolidating the list of factors APHIS considers when evaluating the animal health status of a foreign region and by setting out new factors APHIS will consider when evaluating a region as historically free of a specific disease. These changes will make clearer the types of information APHIS needs from a requesting region in order to conduct an evaluation.
We are reopening the comment period for our interim final rule that will establish a herd certification program to control chronic wasting disease (CWD) in farmed or captive cervids in the United States. The interim final rule requested comment on our decision that our regulations will set minimum requirements for the interstate movement of farmed or captive cervids but not preempt State or local laws or regulations that are more restrictive than our regulations, except any such laws or regulations that prohibit or further restrict the transit through a State of deer, elk, and moose that are otherwise eligible for interstate movement. This action will allow interested persons additional time to prepare and submit comments on our preemption policy with respect to CWD. This document also indicates that we will consider comments on issues other than our preemption policy for future rulemaking.
The Food Safety and Inspection Service (FSIS) is announcing that it is restructuring the United States National Residue Program (NRP) with respect to how sampling of chemical compounds and animal production and egg product classes is scheduled. To complement this new approach to sampling and scheduling, the Agency is implementing several multi-residue methods for analyzing samples of meat, poultry, and egg products for animal drug residues, pesticides, and environmental contaminants in its inspector-generated testing program. These modern, high-efficiency methods will conserve resources and provide useful and reliable results while enabling FSIS to analyze each sample for more chemical compounds than was previously possible.
We are amending a final rule, which will take effect when these amendments become effective, that will establish a herd certification program to control chronic wasting disease (CWD) in farmed or captive cervids in the United States. Under that rule, owners of deer, elk, and moose herds who choose to participate in the CWD Herd Certification Program would have to follow requirements for animal identification, testing, herd management, and movement of animals into and from herds. This document amends that final rule to provide that our regulations will 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 requests public comment on that change. This document also amends the final rule to require farmed or captive deer, elk, and moose to participate in the Herd Certification Program and to be monitored for CWD for 5 years before they can move interstate, clarify our herd inventory procedures, establish an optional protocol for confirmatory DNA testing of CWD-positive samples, add a requirement to continue testing cervids that are killed or sent to slaughter from Certified herds, and make several other changes. These actions will help to control the incidence of CWD in farmed or captive cervid herds and prevent its spread.
We are reopening the comment period for our interim rule that amended the regulations concerning the importation of animals and animal products to prohibit or restrict the importation of bird and poultry products from regions where any subtype of highly pathogenic avian influenza (HPAI) is considered to exist. The interim rule also imposed restrictions concerning importation of live poultry and birds that have been vaccinated for certain types of HPAI, or that have been moved through regions where any subtype of HPAI is considered to exist. This action will give the public an additional opportunity to comment on the interim rule and on a change to its provisions that we are considering.
We are amending the horse protection regulations to require horse industry organizations or associations that license Designated Qualified Persons to assess and enforce minimum penalties for violations of the Horse Protection Act (the Act). The regulations currently provide that such penalties will be set either by the horse industry organization or association or by the U.S. Department of Agriculture. This action will strengthen our enforcement of the Act by ensuring that minimum penalties are assessed and enforced consistently by all horse industry organizations and associations that are certified under the regulations by the U.S. Department of Agriculture.
The Food Safety and Inspection Service (FSIS) is confirming that it will implement routine verification testing for six Shiga toxin-producing Escherichia coli (STEC), in addition to E. coli O157:H7, in raw beef manufacturing trimmings beginning June 4, 2012. FSIS is also responding to comments on the final determination published September 20, 2011, in the Federal Register regarding the June 4, 2012, implementation of STEC sampling and related issues.
The Food Safety and Inspection Service (FSIS) is implementing provisions of the Food, Conservation, and Energy Act of 2008 by amending the Federal meat and poultry products inspection regulations to require official establishments to promptly notify the appropriate District Office that an adulterated or misbranded meat or poultry product has entered commerce; require official establishments to prepare and maintain written procedures for the recall of all meat and poultry products produced and shipped by the establishment; and require official establishments to document each reassessment of the establishment's Hazard Analysis and Critical Control Point (HACCP) plans.
We are correcting an error in the regulatory text of an interim rule that amended the bovine tuberculosis regulations by establishing two separate zones with different tuberculosis risk classifications for the State of New Mexico. The interim rule was published in the Federal Register on March 23, 2009 (74 FR 12055-12058, Docket No. APHIS-2008-0124).
We are removing lists of regions classified with respect to certain animal diseases and pests, and lists of States approved to receive horses imported from foreign regions where contagious equine metritis (CEM) exists, from our animal and animal product import regulations. Instead, the lists will be posted on the Animal and Plant Health Inspection Service's (APHIS') Web site. The regulations will provide the Web address and explain APHIS' criteria and processes for adding a region or a State to, or removing a region or State from, each of the lists. Because the lists will no longer be in the Code of Federal Regulations, changing the lists will no longer require rulemaking. We will keep the public informed of changes to the lists and provide opportunity for public comment through publications in the Federal Register . This rule will enable APHIS to more quickly recognize changes in the disease or pest status of foreign regions and approve States to receive horses from foreign regions where CEM exists. This rulemaking does not change the technical criteria APHIS uses to evaluate whether a foreign region should be added to or removed from a list or the criteria for approving a State to receive horses imported from foreign regions where CEM exists.
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to Title 9 after this date.
The Food Safety and Inspection Service (FSIS) is proposing to amend 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 imported product foreign inspection and foreign establishment certificate processes. In addition, the Agency is proposing to delete the discontinued “streamlined” import inspection procedures for Canadian product and to require Sanitation Standard Operating Procedures (SOPs) at official import inspection establishments. In addition to the proposed regulatory amendments outlined above, FSIS is announcing its intention to discontinue 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.
The Food Safety and Inspection Service (FSIS) is proposing to add the Republic of Korea (Korea) to the list of countries eligible to export poultry products to the United States. Reviews by FSIS of Korea's laws, regulations, and inspection implementation show that its poultry inspection system requirements are equivalent to the Poultry Products Inspection Act (PPIA) and its implementing regulations. Under this proposal, slaughtered poultry or parts or other products thereof processed in certified Korean establishments would be eligible for export to the United States. All such products would be subject to re-inspection at United States ports-of-entry by FSIS inspectors.
We are reopening the comment period for our proposed rule that clarified our interpretation of the veterinary practitioner exemption provided by the Virus-Serum-Toxin Act. This action will allow interested persons additional time to prepare and submit comments.
We are proposing to amend the Virus-Serum-Toxin Act regulations to require that veterinary biologics prepared under the veterinary practitioner exemption must be prepared at the same facility the veterinarian utilizes in conducting the day-to-day activities associated with his or her practice. This exemption applies to veterinary biologics prepared by a veterinary practitioner solely for administration to animals in the course of a State-licensed professional practice of veterinary medicine under a veterinarian-client-patient relationship. This proposed amendment is necessary to ensure that veterinary biologics are not prepared in unlicensed establishments in violation of the Virus-Serum-Toxin Act. The effect of the proposed amendment would be to clarify the regulations regarding the preparation of product by a veterinary practitioner under a veterinarian-client-patient relationship.
We are extending the comment period for our proposed rule that would revise the definition of retail pet store and related regulations to bring more pet animals sold at retail under the protection of the Animal Welfare Act (AWA). We are also announcing the availability of a revised factsheet regarding our proposal. These actions will allow interested persons additional time to prepare and submit comments.
We are reopening the comment period for our proposed rule that would amend the regulations that govern the importation of animals and animal products to revise the conditions for the importation of live bovines and products derived from bovines with regard to bovine spongiform encephalopathy. This action will allow interested persons additional time to prepare and submit comments.
We are proposing to revise the definition of retail pet store and related regulations to bring more pet animals sold at retail under the protection of the Animal Welfare Act (AWA). Specifically, we would narrow the definition of retail pet store so that it means a place of business or residence that each buyer physically enters in order to personally observe the animals available for sale prior to purchase and/or to take custody of the animals after purchase, and where only certain animals are sold or offered for sale, at retail, for use as pets. Retail pet stores are not required to be licensed and inspected under the AWA. We are also proposing to increase from three to four the number of breeding female dogs, cats, and/or small exotic or wild mammals that a person may maintain on his or her premises and be exempt from the licensing and inspection requirements if he or she sells only the offspring of those animals born and raised on his or her premises, for pets or exhibition. This exemption would apply regardless of whether those animals are sold at retail or wholesale. This proposed rule is necessary to ensure that animals sold at retail are monitored for their health and humane treatment and to concentrate our regulatory efforts on those facilities that present the greatest risk of noncompliance with the regulations.
The Food Safety and Inspection Service (FSIS) is issuing this document to propose to clarify its requirements for validation by an official establishment of its Hazard Analysis Critical Control Point (HACCP) system, that is, validation of both the critical control points (CCPs) in the HACCP plan and any interventions or processes used to support decisions in the hazard analysis. Validation of a HACCP system involves two separate elements: The scientific or technical support for the judgments made in designing the HACCP system, and evidence derived from the execution of the HACCP plan to demonstrate that it is, in fact, achieving the critical operational parameters documented in the scientific or technical support. The Agency is also announcing the availability of, and requesting comments on, a revised draft guidance document prepared to assist establishments in appropriately validating their HACCP systems. The Agency received and analyzed comments on the initial draft of this guidance, which the Agency posted on its Web site in March 2010. FSIS is soliciting comments on this revised guidance and will hold a public meeting to discuss the revised guidance before it issues final guidance for HACCP systems validation.
The Food Safety and Inspection Service (FSIS) is proposing to remove sodium benzoate, sodium propionate, and benzoic acid from the list of substances that the regulations prohibit for use in meat or poultry products. Under this proposal, new uses of these substances in meat or poultry products would continue to be approved by the Food and Drug Administration (FDA) for safety and by FSIS for suitability. FSIS would add approved uses of these substances to the list of approved substances contained in the Agency's directive system.
The Food Safety and Inspection Service (FSIS) is extending the comment period for the proposed rulemaking “Modernization of Poultry Slaughter Inspection” and responding to questions and addressing issues that have been raised concerning the proposed rule. The comment period was scheduled to close on April 26, 2012. During the comment period, a coalition of consumer advocacy organizations and two trade associations representing the poultry industry asked that FSIS clarify certain aspects of the proposed rule to help inform their comments. This document summarizes the issues raised by these groups and FSIS's response. FSIS is also soliciting additional comments on how it should implement the final rule resulting from the proposal and requesting available data on any worker safety issues associated with increased line speeds. FSIS received a request to hold a public technical meeting on the proposed rule. FSIS does not believe that such a meeting would be useful. The Agency will, however, assess public understanding of the proposed rule in connection with its review and evaluation of the comments submitted and will respond as appropriate.
On March 19, 2012, the Food Safety and Inspection Service (FSIS) published a proposed rule to amend the meat and poultry products regulations pertaining to the schedule of operations. The Regulatory Identification Number (RIN) was inadvertently omitted. The RIN number for this proposed rule is 0583-AD48. Comments on the March 19 proposed rule must still be received by the agency on or before April 18, 2012, to be assured of consideration.
The Food Safety and Inspection Service (FSIS) is proposing to amend the meat and poultry products regulations pertaining to the schedule of operations. FSIS is proposing to amend these regulations to define the 8-hour workday as including time that inspection program personnel need to prepare the inspection station, if necessary, or retrieve and return lot tally sheets; the time necessary for FSIS inspection program personnel to sharpen knives, if necessary; and the time necessary to conduct duties scheduled by FSIS, including administrative activities. The activities are integral and indispensable to inspectors' work and are part of the continuous workday as defined by the Fair Labor Standards Act. Therefore, they are activities that need to be part of the Agency's regulatory definition for the 8-hour workday.
We are proposing to amend the regulations that govern the importation of animals and animal products to revise the conditions for the importation of live bovines and products derived from bovines with regard to bovine spongiform encephalopathy (BSE). We are proposing to base importation conditions on the inherent risk of BSE infectivity in specified commodities, as well as on the BSE risk status of the region from which the commodities originate. We are proposing to establish a system for classifying regions as to BSE risk that is consistent with the system employed by the World Organization for Animal Health (OIE), the international standard-setting organization for guidelines related to animal health. The conditions we are proposing for the importation of specified commodities are based on internationally accepted scientific literature and, except in a few instances, are consistent with guidelines set out in the OIE's Terrestrial Animal Health Code. We are also proposing to classify certain specified countries as to BSE risk and are proposing to remove BSE restrictions on the importation of cervids and camelids and products derived from such animals. We are proposing to make these amendments after conducting a thorough review of relevant scientific literature and a comprehensive evaluation of the issues and concluding that the proposed changes to the regulations would continue to guard against the introduction of BSE into the United States, while allowing the importation of additional animals and animal products into this country. In this document we are also affirming the position we took in removing the delay of applicability of certain provisions of the rule entitled “Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities,” published in the Federal Register on January 4, 2005 (70 FR 460-553). The delay of applicability was removed in a final rule entitled “Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived from Bovines,” published in the Federal Register on September 18, 2007 (72 FR 53314-53379).
The Food Safety and Inspection Service (FSIS) is proposing a new inspection system for young chicken and turkey slaughter establishments that would replace the current Streamlined Inspection System (SIS), the New Line Speed Inspection System (NELS), and the New Turkey Inspection System (NTIS). The Agency is also proposing several changes that would affect all establishments that slaughter poultry other than ratites, regardless of the inspection system under which they operate. This proposed rule is a result of the Agency's 2011 regulatory review efforts conducted under Executive Order 13563 on Improving Regulation and Regulatory Review.
The Food Safety and Inspection Service (FSIS) is proposing to amend the meat and poultry inspection regulations to provide for an electronic export application and certification system. The electronic export application and certification system will be a component of the Agency's Public Health Information System (PHIS). The export component of PHIS will be available as an alternative to the paper-based application and certification process. FSIS is proposing to charge users for the use of the proposed system. FSIS is proposing to establish a formula for calculating the fee. FSIS intends to publish notice of the fee, using the formula, in the Federal Register on an annual basis. FSIS is also proposing to provide flexibility in the requirements for official export inspection marks, devices, and certificates. In addition, FSIS is proposing to amend the egg product export regulations that parallel the meat and poultry product export regulations.
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