95-31393. FSIS Agenda for Change: Regulatory Review  

  • [Federal Register Volume 60, Number 250 (Friday, December 29, 1995)]
    [Proposed Rules]
    [Pages 67469-67474]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 95-31393]
    
    
    
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    DEPARTMENT OF AGRICULTURE
    
    Food Safety and Inspection Service
    
    9 CFR Parts 301, 304, 305, 306, 307, 318, 325, and 381
    
    [Docket No. 95-008A]
    RIN 0583-AB89
    
    
    FSIS Agenda for Change: Regulatory Review
    
    AGENCY: Food Safety and Inspection Service, USDA.
    
    ACTION: Advance Notice of Proposed Rulemaking; Request for Comments.
    
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    SUMMARY: The Food Safety and Inspection Service (FSIS) has begun a 
    comprehensive review of its regulatory procedures and requirements to 
    determine which are still needed and which ought to be modified, 
    streamlined, or eliminated. This review is an integral part of the FSIS 
    initiative to improve the safety of meat and poultry products by 
    modernizing the Agency's system of food safety regulation. It also 
    moves beyond the page-by-page review of FSIS regulations carried out 
    earlier this year under the President's Reinvention of Government 
    Initiative. A thorough review of FSIS's regulations is needed to 
    prepare for implementation of the Agency's proposed Hazard Analysis and 
    Critical Control Points (HACCP) regulations and a new food safety 
    strategy that will reduce reliance on command-and-control regulations 
    and increase reliance on science-based preventive measures and 
    performance standards to improve food safety. This review and any 
    changes in FSIS regulations that are necessary to make them compatible 
    with HACCP will be completed prior to implementation of HACCP. FSIS 
    invites comment from the public and all interested parties on the 
    Agency's preliminary review of its regulations and specific suggestions 
    on which regulations need to be eliminated or changed to be compatible 
    with HACCP, and how they should be changed, or to achieve Reinvention 
    of Government goals of having fewer, clearer, and more user-friendly 
    regulations.
        Some of the rulemakings needed to streamline existing requirements 
    and carry out the FSIS food safety strategy are being initiated or 
    effectuated in documents that appear elsewhere in this issue of the 
    Federal Register: A proposed rule that would eliminate the FSIS prior 
    approval system for substances added to meat and poultry products; a 
    proposed rule that would facilitate marketing of nutritionally improved 
    alternatives to standardized meat and poultry food products; and a 
    final rule streamlining the prior approval system for meat and poultry 
    labels.
        As FSIS progresses in its comprehensive regulatory review, FSIS 
    will publish further proposals to eliminate unnecessary regulations and 
    modify remaining regulations, replacing, to the extent possible, 
    command-and-control regulations with performance standards, clarifying 
    the role of inspectors in enforcing those standards, and reorganizing 
    and simplifying the regulations to make them easier to understand and 
    use.
    
    DATES: Comments must be received on or before February 27, 1996.
    
    ADDRESSES: Please send an original and two copies of written comments 
    to Policy, Evaluation, and Planning Staff, Attn: FSIS Docket Clerk, 
    DOCKET No. 95-008A, Room 4352 South Building, Food Safety and 
    Inspection Service, U.S. Department of Agriculture, Washington, DC 
    20250. Oral comments, as permitted under the Poultry Products 
    Inspection Act, should be directed to the person listed under FOR 
    FURTHER INFORMATION CONTACT.
    
     
    [[Page 67470]]
    
    FOR FURTHER INFORMATION CONTACT: Dr. Paula M. Cohen, Director, 
    Regulations Development, at (202) 720-7164.
    
    SUPPLEMENTARY INFORMATION:
    
    Table of Contents
    
    I. FSIS Regulatory Reform Strategy
    II. Comprehensive Review and Reorganization of FSIS Regulations
    III. Initial Review of Regulations; Consistency with HACCP
    IV. Request for Comments
    
    I. FSIS Regulatory Reform Strategy
    
        The Food Safety and Inspection Service is responsible for carrying 
    out the mandates of the Federal Meat Inspection Act (21 U.S.C. 601 et 
    seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and 
    most recently, the Egg Products Inspection Act (21 U.S.C. 1031 et 
    seq.), by ensuring that meat, meat food, poultry, and egg products are 
    safe, wholesome, not adulterated, and properly marked, labeled, and 
    packaged. FSIS and its predecessor agencies have protected consumers 
    for nearly a century primarily through in-plant inspection procedures 
    to assure that raw animal tissues are free of disease and visible 
    contamination, that further processed products are processed under 
    appropriate controls and meet applicable composition requirements, and 
    that all products are produced under sanitary conditions and are 
    packaged and labeled in a manner that is not misleading.
        The Agency's inspection programs have contributed significantly to 
    the safety and quality of meat and poultry products consumed in this 
    country. Increasingly, however, the need to reassess these programs and 
    to reshape them to meet the challenges of the future has become 
    apparent. Today, FSIS is confronting three imperatives: (1) The need to 
    improve food safety to meet persistent as well as changing threats to 
    public health; (2) the need to make better use of scarce resources in 
    meeting those public health challenges; and (3) the need to reexamine 
    its regulations, culling out or reforming those that are obsolete, 
    impose unnecessary burdens or are inconsistent with Agency food safety 
    initiatives, and restructure the essential regulations that remain to 
    make them easier to understand and use.
    
    Need To Improve Food Safety
    
        The need to take steps to improve food safety has been underscored 
    by events of recent years. The early-1993 outbreak of illness in the 
    Western United States, linked to hamburger patties contaminated with 
    the bacterium E. coli O157:H7, showed that there are gaps in the 
    inspection system--most significantly the lack of measures to target, 
    control, and reduce contamination of raw meat and poultry products with 
    pathogenic microorganisms. Since 1993, the Agency has adopted 
    regulatory control, research, and education measures to help fill these 
    gaps in the system and address the public health problem of foodborne 
    illness associated with such contamination. Among these measures are 
    regulations mandating safe handling labels on all raw, not ready-to-
    eat, meat and poultry products (9 CFR 317.2(l); 381.125(b)(1)(i)). The 
    Agency has strongly encouraged the regulated industry to find ways of 
    reducing and controlling the levels of microbial pathogens on meat and 
    poultry products. The Agency also has begun a program to test raw 
    ground beef for E. coli O157:H7 and to take regulatory action on 
    product found to be adulterated with this dangerous organism.
    
    Pathogen Reduction/HACCP Proposal
    
        On February 3, 1995, FSIS published a rulemaking proposal, 
    ``Pathogen Reduction; Hazard Analysis Critical Control Point (HACCP) 
    Systems'' (60 FR 6774), which begins a fundamental transformation of 
    the Agency's program designed to reduce significantly the incidence of 
    foodborne illness associated with meat and poultry products. The notice 
    enunciated the FSIS food safety goal: To reduce the risk of foodborne 
    illness associated with the consumption of meat and poultry products to 
    the extent possible by ensuring that appropriate and feasible measures 
    are taken at each step in the food production process where hazards can 
    enter and where procedures and technologies exist or can be developed 
    to prevent the hazard or reduce the likelihood it will occur.
        HACCP is conceptually a simple system by which food processors 
    identify and evaluate hazards to the production of safe products, 
    institute controls necessary to reduce or eliminate these hazards, 
    monitor the performance of these controls, and maintain records of this 
    monitoring, as a matter of routine. HACCP embodies the principle that 
    the management of every plant is responsible for building into its food 
    production process systematic measures to ensure the safety of the food 
    the plant produces.
        For HACCP to be successful, it must be accompanied by appropriate 
    food safety performance standards, which can provide a means to 
    determine whether a plant's HACCP plan is adequate and working 
    effectively to achieve an acceptable level of food safety performance. 
    Such standards have long existed for chemical food additives and 
    pesticide residues, in the form of tolerances or legal limits on the 
    level of additive or residue that may be safely present in food. FSIS 
    has also maintained performance standards for pathogenic microorganisms 
    on cooked or ready-to-eat meat and poultry products, typically in the 
    form of zero tolerances (or prohibitions) on the presence of such 
    harmful bacteria as Salmonella and Listeria monocytogenes. In 
    conjunction with HACCP and the Agency's new food safety strategy, FSIS 
    is now moving for the first time toward performance standards for 
    pathogenic microorganisms on raw products.
        With this approach, slaughter plants will have an additional 
    incentive to improve their processes to reduce the risk of harmful 
    contamination and greater flexibility to adopt innovative new pathogen 
    reduction procedures and technologies in a more efficient and effective 
    manner than under the current system.
        Where appropriate and useful, and to mitigate any negative impact 
    of proposed rules, FSIS intends to propose performance standards which, 
    while affording plants the freedom to innovate, could be met by 
    following the procedures in the current regulations.
        Performance standards are consistent with the HACCP philosophy, 
    which more clearly delineates the roles and responsibilities of 
    industry and Government than does the current regulatory approach. With 
    establishments free to develop plant-specific means of achieving FSIS-
    defined food safety objectives, the Agency will be able to better focus 
    inspection resources on essential HACCP-related functions and other 
    tasks more focused on process than product.
    
    II. Comprehensive Review and Reorganization of FSIS Regulations
    
        To be better prepared to pursue its food safety goals, FSIS has 
    thoroughly reexamined its regulatory oversight roles, resource 
    allocation, and organizational structure. This top-to-bottom review of 
    the Agency was conducted in parallel with and in support of the 
    Pathogen Reduction/HACCP rulemaking. FSIS made the preliminary reports 
    on this review available to the public and, in a Federal Register 
    notice (60 FR 47346; September 12, 1995), invited comment on the 
    analysis and options that had been developed. How to redeploy 
    inspectional resources to more 
    
    [[Page 67471]]
    productively focus on food safety objectives was a key component of the 
    top-to-bottom review, and continues to engage the Agency.
        The inspection regulations have accumulated over many years. The 
    meat inspection regulations (9 CFR subchapter A), the poultry 
    inspection regulations (9 CFR subchapter C), and the egg product 
    inspection regulations, under FSIS jurisdiction since June 1995 (7 CFR 
    part 59), were developed independently of one another; all began 
    separately as programs administered by different agencies. These 
    distinct sets of regulations have retained their separate identities in 
    the Code of Federal Regulations, despite the fact that they are now 
    administered by the same agency and a large proportion of the 
    regulations are virtually identical. Because of this structure, when a 
    change is made to one of these inspection programs, the same or a 
    similar change must usually be made to the others.
        Many of the provisions in the meat and poultry (and now egg 
    products) regulations should be, but are not, identical. The 
    differences in the provisions addressing similar topics are largely 
    historical artifacts which should be eliminated. These differences 
    frequently cause confusion, making the administration of inspection 
    more difficult and resource-intensive than it ought to be. For example, 
    a time limit for appealing inspection decisions exists under the 
    poultry regulations but not under the meat regulations (9 CFR 306.5; 
    381.35). Similarly, there is a 180 deg.F temperature requirement for 
    water used to clean and disinfect meat slaughterhouses (9 CFR 
    308.3(d)(4), 308.8) but not poultry establishments (9 CFR 381.50(b), 
    381.58(a)).
        Although there are necessary differences in how products of the 
    different industries are regulated, there are many differences for 
    which there is no clear necessity. In some cases, it is argued, these 
    differences are not only unjustified, but they are unfair in favoring 
    one industry at the expense of the other.
        In 1992, FSIS contracted with the Research Triangle Institute (RTI) 
    to conduct a review and comparison of the Agency's meat and poultry 
    regulations. The report, delivered to the Agency in June 1993, found 12 
    areas with substantive differences in the regulations that might be 
    ``potentially significant in terms of relative costs of administering 
    the two regulatory programs.''
        A review of that report suggests at least three areas of regulation 
    where this may currently be the case: slaughter inspection controls 
    (only poultry has detailed finished product standards, which permit 
    faster line speeds and other plant efficiencies), removal of 
    contamination (poultry can be reprocessed by washing, but meat must be 
    trimmed), and exemptions from inspection (there are more categories of 
    exempted poultry establishments than there are exempted meat 
    establishments, and the poultry regulations are more definitive in 
    describing products not subject to inspection). Significant differences 
    in a fourth area, ``mechanically separated product,'' were resolved in 
    a final rule published in the Federal Register on November 3, 1995 (60 
    FR 55962).
        FSIS will carefully scrutinize all meat, poultry, and egg 
    inspection regulations with a view to merging and restructuring the 
    regulations and to unifying most of the provisions that are common to 
    them. As each regulatory area is reviewed, FSIS will carefully consider 
    the validity of any differences in how the industries are regulated and 
    will keep separate only those provisions that must remain separate. The 
    merging and restructuring would simplify the regulations; enhance 
    administrative efficiency; and remove unnecessary, often confusing, and 
    sometimes burdensome, differences in the regulatory treatment of FSIS-
    inspected establishments and their products.
        During the next few years, the Agency will review and restructure 
    all of its regulations to make them easier to use. This reflects the 
    Agency's position that its regulations could be more clearly understood 
    if better organized and written in ``plain English.''
        In conjunction with the comprehensive regulatory review now in 
    progress, FSIS is undertaking a review of its manuals, bulletins, 
    directives, notices, and instructions to its employees on how to 
    implement specific regulations. FSIS will address longstanding concerns 
    that, as the inspection program has evolved, procedural changes have 
    been introduced without systematic consideration of whether the new 
    procedures overlap or are inconsistent with other procedures. The 
    result has been the creation of redundant or conflicting procedures on 
    top of one another, causing confusion and the potential for nonuniform 
    application of inspection requirements from place to place. Further, 
    FSIS questions whether the many kinds of issuances continue to be 
    useful, and requests comment on how the Agency can best communicate 
    instructions for implementing regulations.
    
    III. Initial Review of Regulations; Consistency With HACCP
    
        As discussed in conjunction with the FSIS regulatory proposal of 
    February 3, 1995 (60 FR 6774), FSIS does not intend simply to add the 
    new HACCP system to the current system of inspection and regulation. 
    FSIS intends to integrate HACCP into a modernized system of inspection 
    and regulation that will harness the power of prevention and 
    performance standards to improve food safety and make better use of the 
    Agency's resources. To accomplish this, FSIS must review all of its 
    existing regulatory requirements and procedures and modify, streamline, 
    or eliminate them, as appropriate, to be compatible with the new food 
    safety strategy. FSIS has already targeted a number of its regulations 
    for elimination or reform and is seeking in this document public input 
    as a first step in the rulemaking required to achieve the needed 
    changes.
        Earlier this year, partly to identify rule changes needed for 
    HACCP-based inspection and partly to meet requirements of the 
    President's Reinventing Government Initiative, FSIS conducted an 
    initial page-by-page review of existing regulations. The Agency 
    identified for possible revision or elimination more than 400 pages of 
    regulations. Almost three-quarters of the regulations administered by 
    FSIS were projected to be eliminated or changed to make them simpler, 
    less burdensome, or more performance-based.
        As part of its overall food safety initiative, the Agency is 
    committed to moving beyond that initial review to making specific 
    proposals for the near term and to comprehensive regulatory reform to 
    be completed during the next few years.
    
    Reporting and Recordkeeping
    
        Further, in line with the Administration's policy to reduce 
    reporting requirements in Government programs, FSIS invites comment on 
    its paperwork or recordkeeping requirements. The Agency seeks specific 
    recommendations for eliminating, simplifying, or otherwise changing 
    information collection requirements. FSIS also seeks recommendations 
    for improving or eliminating currently required forms (FSIS Form 7234-
    1, the form accompanying label submissions, for example, or FSIS Form 
    8820-2, the form meat and poultry establishment personnel complete if 
    inspectors find deficiencies in processing operations).
        Questions of particular concern include the following:
         Despite efforts to prevent this, has FSIS issued 
    duplicative or redundant 
    
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    requirements? Do FSIS' information and recordkeeping requirements 
    overlap with those of other Federal, State, or local agencies?
         Should individual FSIS forms be modified or combined? If 
    so, how?
         Should FSIS allow respondents to use facsimiles, 
    computers, or other automated collection systems or information 
    transfer technologies? If so, for which information requirements?
         Would it be helpful for FSIS to accompany information 
    requirements with format suggestions?
         Generally, how might FSIS make information collection 
    activities less burdensome?
    
    Current Activity
    
        FSIS has decided to publish the following documents at this time:
         Rulemaking to make FSIS food safety regulations compatible 
    with HACCP and to eliminate redundant or unnecessary rules, initiated 
    in this Advance Notice of Proposed Rulemaking (ANPR);
         Rulemaking to eliminate the FSIS prior-approval system for 
    substances added to meat and poultry products, a process initiated in a 
    proposed rule, ``Substances Approved for Use in the Preparation of Meat 
    and Poultry Products,'' docket #88-026P, published elsewhere in this 
    issue of the Federal Register;
         Rulemaking to amend existing standards of identity to give 
    manufacturers greater flexibility in marketing nutritionally improved 
    (e.g., reduced-fat) meat and poultry products, ``Food Standards: 
    Processed Meat and Poultry Products Named by Use of an Expressed 
    Nutrient Content Claim and Standardized Name'' (docket #92-024P), 
    published elsewhere in this issue of the Federal Register); and
         A final rule streamlining the prior-approval system for 
    meat and poultry labels, ``Prior Labeling Approval System,'' docket 
    #92-012F, published elsewhere in this issue of the Federal Register.
        Further, FSIS is actively developing the following: a proposal to 
    convert remaining rules as much as possible from command-and-control 
    prescriptions to performance standards (``Performance Standards for the 
    Production of Certain Cooked Meat and Poultry Products''); a proposal 
    to eliminate prior-approval programs for facility blueprints, 
    processing equipment, and most quality control plans (``Elimination of 
    Prior Approval Requirements for Establishment Drawings and 
    Specifications, Equipment, and Certain Partial Quality Control 
    Programs''); and an advance notice of proposed rulemaking soliciting 
    comments and information on whether to modify or eliminate specific 
    standards and whether, and if so how, to modify the Agency's overall 
    approach to product standards (``Meat and Poultry Standards of Identity 
    and Composition'').
    
    Planned Actions
    
         Review of all prior-approval regulations not addressed in 
    the above-mentioned documents, with related rulemaking proposals 
    projected for publication during 1996;
         Restructuring of FSIS meat inspection regulations and 
    poultry inspection regulations, which are currently in different 
    subchapters of the Code of Federal Regulations, to eliminate 
    duplicative and redundant requirements and make the regulations easier 
    to use (initiated in this ANPR).
        FSIS invites public comment on all aspects of this regulatory 
    reform initiative based on the discussion contained in the ANPR and in 
    the companion rulemaking proposals.
    
    Command-and-Control Regulations and Consistency With HACCP
    
        The Pathogen Reduction/HACCP proposal referred to above reflects a 
    basic shift in FSIS's approach to overseeing the safety of meat and 
    poultry products. FSIS intends to rely less on command-and-control 
    requirements, which specify, often in great detail, how a plant is to 
    achieve a particular food safety objective, and more on performance 
    standards, which state an objective or level of performance plants are 
    expected to achieve, and allow for greater flexibility on the part of 
    the plant in determining how to achieve them. This shift to performance 
    standards and greater flexibility for meat and poultry plants is the 
    basis of FSIS's intention to further stimulate the innovative capacity 
    of the meat and poultry industry to improve the safety of its products.
        This shift is also compelled by the philosophy underlying HACCP. 
    HACCP enables plant management to build science-based controls to 
    prevent food safety hazards into its food production processes, and 
    recognizes that the specific controls and related measures--the HACCP 
    plans--required to ensure food safety can vary from plant to plant.
        Where appropriate, command-and-control regulations must be changed 
    to provide greater flexibility for industry to design and implement 
    processes and HACCP systems of control, tailored to the circumstances 
    of each plant. This is consistent with the HACCP approach, which 
    clearly delineates industry and Government responsibility for food 
    safety, with plants establishing procedures they will follow to ensure 
    the production of safe food. FSIS must carefully reconsider all of its 
    regulations that mandate specific actions, techniques, or processing 
    parameters designed to achieve a food safety objective and determine 
    whether they should be eliminated or modified to provide the 
    flexibility required to be consistent with HACCP. However, any changes 
    will not compromise food safety standards or objectives required to 
    protect public health.
        FSIS must also modify its regulations in varying respects to 
    reflect the anticipated changes in the roles FSIS inspectors will play 
    in plants operating under HACCP.
        Table 1 lists the regulations FSIS has identified as candidates for 
    modification or elimination to be consistent with HACCP. Comments 
    submitted during that public comment period also identified candidates 
    for modification or elimination. The comments are being evaluated by 
    FSIS and will be taken into account as the Agency proceeds with the 
    necessary rulemaking. Any changes in these or other FSIS regulations 
    that are required to be consistent with HACCP will be completed before 
    plants are required to comply with new HACCP requirements.
        Notably, the following categories of regulations in title 9 of the 
    CFR are being reviewed for consistency with HACCP:
         Definitions (Secs. 301.2 and 381.1);
         Inauguration, suspension, and withdrawal of inspection 
    (Secs. 305.4, 305.5, and 381.19-381.21, and 381.29);
         Appeals procedures and related administrative procedures 
    (Secs. 306.5, 335.40, and 381.35);
         Reinspection of product entering establishments, and 
    retention and disposition of product (Secs. 318.2 and 381.145);
         Restrictive, command-and-control-type regulations which 
    delimit processing and treatment methods intended to eliminate specific 
    food safety hazards such as trichinae in pork; mechanically separated 
    product, and various poultry products; and the potential hazards of 
    improper thermal processing of meat and poultry products and 
    irradiation of poultry (Secs. 318.6, 318.10, 318.12-318.20, 318.22-
    318.24, and 318.300-318.311; and 381.148-381.152 and 318.300-381.311); 
    and
         Recordkeeping and access to records under the Freedom of 
    Information Act (Secs. 320.5-320.7, 381.179-381.181; 390.1-390.8).
        FSIS is also reviewing all of its regulations, policies, and 
    inspection 
    
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    procedures concerning plant sanitation (Secs. 308.3-308.16 and 
    Secs. 381.45-381.61). Although implementation of the requirement 
    proposed on February 3, 1995, for sanitation standard operating 
    procedures (SOP's) would not depend on revisions to the Agency's 
    sanitation regulations, the Agency recognizes the need to more clearly 
    state the performance standards in this area. Basic sanitation and 
    plant hygiene practices are, from a food-safety perspective, among the 
    most important requirements in the regulations. The Agency believes 
    that the regulations can be made much clearer in describing the 
    establishments' roles and their responsibility for much of the routine 
    work in this area, so that Federal inspection resources can be 
    allocated to new, HACCP-related functions.
        FSIS also invites comment on the relationship between HACCP and the 
    existing regulations governing postmortem inspection in slaughter 
    plants (9 CFR parts 310 and 381.76 et seq.). HACCP is intended to 
    address all significant avenues of hazard affecting the safety of meat 
    and poultry products. The FSIS postmortem inspection program, which 
    carries out the statutory mandate for carcass-by-carcass examination by 
    Federal inspectors, is designed to achieve an array of consumer 
    protection values, including exclusion of diseased animals from the 
    food supply and enforcement of standards regarding visible carcass 
    defects and contamination with visible filth, fecal matter, or other 
    extraneous materials, some of which affect the safety of the product 
    and some of which do not. HACCP plans for slaughter plants will include 
    one or more critical control points in the slaughter and carcass 
    dressing process, which will require inspectional oversight by FSIS 
    and, possibly, some modification of the current postmortem inspection 
    regulations. FSIS invites comment on what the relationship should be 
    between HACCP and the current postmortem inspection regulations and 
    activity, including specific suggestions for the manner in which 
    current regulations should be modified to be consistent with HACCP.
    
             Table 1.--Regulations That Are Candidates for Revision or Removal Prior to HACCP Implementation        
    ----------------------------------------------------------------------------------------------------------------
         Regulations--FMIA, PPIA                   Subject                             Possible action              
    ----------------------------------------------------------------------------------------------------------------
    9 CFR Part                                                                                                      
        301, 381, Subpart A.........  Definitions......................  Include general HACCP-related terms and    
                                                                          redefine inspection organization and      
                                                                          activity terms.                           
        304, 381, Subpart D.........  Application for and grant or       Revise prior approval procedures (e.g.,    
                                       refusal of inspection.             eliminating provisions of Sec.  381.19);  
                                                                          shift to performance standards.           
        305 and 306, 381, Subparts E  Inauguration and withdrawal of     Clarify role of inspection program. (See,  
         and F.                        inspection; inspection program     e.g., Sec.  305.4). Integrate Secs.  305.5
                                       employees.                         and 381.29 with rules for suspending and  
                                                                          withdrawing inspection. (See Part 335 and 
                                                                          Part 381, Subpart W.)                     
                                                                         Assure that appeal procedures in Secs.     
                                                                          306.5 and 381.35 comport with enforcement 
                                                                          under HACCP.                              
        307, 381, Subpart G.........  Facilities for inspection........  Clarify standards for essential facilities.
                                                                          (See, e.g., Secs.  307.1, 307.2, and      
                                                                          381.36.)                                  
                                                                         Convert requirements for sanitation and    
                                                                          facilities to performance standards or    
                                                                          decision criteria; supplement with        
                                                                          guidelines as needed. (See, e.g., Secs.   
                                                                          308.3, 308.4, and 381.46-381.52.)         
                                                                         Simplify detailed requirements for         
                                                                          equipment and cleanliness, for example;   
                                                                          convert to performance standards and/or   
                                                                          decision criteria; supplement with        
                                                                          guidelines as needed. (See Secs.  308.6-  
                                                                          308.9, 308.12, 308.13, and 308.16.)       
                                                                         Convert equipment and cleaning requirements
                                                                          to performance standards and/or decision  
                                                                          criteria; supplement with guidelines as   
                                                                          needed. (See Secs.  381.54-381.61.)       
                                                                         Remove obsolete provisions for slack       
                                                                          barrels, similar containers and means of  
                                                                          conveyance, and burlap wrapping. (See     
                                                                          Secs.  308.10 and 308.11.)                
                                                                         Clarify decision criteria concerning       
                                                                          employment of diseased persons. (See Sec. 
                                                                          308.14.)                                  
                                                                         Convert tagging insanitary equipment,      
                                                                          utensils, rooms, and compartments         
                                                                          provisions to performance standards;      
                                                                          clarify role of inspection program        
                                                                          employees. (See Secs.  308.15 and 381.99.)
                                                                         Update rules for temperatures and chilling 
                                                                          and freezing procedures for poultry and   
                                                                          make changes to accommodate HACCP (i.e.,  
                                                                          changes in addition to pathogen reduction 
                                                                          amendments proposed 2/3/95). (See Sec.    
                                                                          381.66 paragraphs (c)(5) and (c)(6).)     
        318, 381, Subparts O and X..  Entry into official                Convert rules for articles entering        
                                       establishments; reinspection;      establishments, and product disposal to   
                                       reinspections, preparing and       performance standards and clarify role of 
                                       processing establishments.         inspection program employees. (See Secs.  
                                                                          318.3 and 381.45(a),(b), and (i).)        
                                                                         Eliminate prior approval procedures for    
                                                                          total quality control systems. (See Secs. 
                                                                          318.4(c)-(h) and 381.145(c)-(g).)         
                                                                         Convert requirements for processing        
                                                                          procedures and articles used in preparing 
                                                                          products to performance standards and     
                                                                          clarify role of inspection program        
                                                                          employees. (See Secs.  318.5, 318.6,      
                                                                          318.8, and 381.148.)                      
    
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                                                                         Eliminate command-and-control type         
                                                                          requirements for the use of nitrite and   
                                                                          sodium ascorbate or erythorbate in bacon; 
                                                                          convert these requirements to performance 
                                                                          standards and clarify role of inspection  
                                                                          program employees. (See Sec.  318.7(b).)  
                                                                         Convert requirements for the treatment of  
                                                                          pork and pork products to destroy         
                                                                          trichinae in to performance standards;    
                                                                          supplement with guidelines as needed. (See
                                                                          Sec.  318.10.)                            
                                                                         Convert requirements for preparing articles
                                                                          not for use as human food (e.g., dog food)
                                                                          to performance standards; clarify role of 
                                                                          inspection program employees; eliminate   
                                                                          command-and-control type requirements.    
                                                                          (See Secs.  318.12 and 381.152.)          
                                                                         Eliminate redundancy with other provisions 
                                                                          (mixtures containing product that are not 
                                                                          classed as meat food products). (See Sec. 
                                                                          318.13.)                                  
                                                                         Convert procedure for handling product     
                                                                          adulterated by polluted water to          
                                                                          performance standards and decision        
                                                                          criteria; supplement with guidelines as   
                                                                          needed. (See Secs.  318.14 and 381.151.)  
                                                                         Convert requirements for tagging chemicals,
                                                                          preservatives, cereals, spices, etc., to  
                                                                          performance standards; clarify role of    
                                                                          inspection program employees. (See Sec.   
                                                                          318.15.)                                  
                                                                         Convert rules for substances such as       
                                                                          pesticide chemical residues, food         
                                                                          additives, and color additives to         
                                                                          performance standards and role of         
                                                                          inspection program employees. (See Sec.   
                                                                          318.16.)                                  
                                                                         Make requirements for handling of certain  
                                                                          material for mechanical deboning          
                                                                          consistent with any new time-temperature  
                                                                          requirements. (See Sec.  318.18.)         
                                                                         Convert compliance procedures for meat     
                                                                          derived from advanced meat/bone separation
                                                                          machinery and recovery systems to         
                                                                          performance standards and clarify role of 
                                                                          inspection program employees. (See Sec.   
                                                                          318.24.)                                  
                                                                         Convert requirements for canning and canned
                                                                          products to performance standards and     
                                                                          clarify role of inspection program        
                                                                          employees. (See Secs.  318.300-318.311 and
                                                                          381.300-381.311.)                         
        325, 381, Subpart S.........  Transportation...................  Eliminate obsolete provisions; focus on and
                                                                          clarify policies and performance          
                                                                          standards.                                
    ----------------------------------------------------------------------------------------------------------------
    
    
    
    IV. Request for Comments
        This ANPR is intended to elicit comments, suggestions, and 
    information that will enable FSIS to provide more efficient and 
    effective service and to focus its organizational resources more 
    closely on health and safety matters, which are of vital concern to all 
    Americans. FSIS specifically requests comment on its efforts to 
    transform its regulations from heavy reliance on command-and-control 
    approaches to greater reliance on performance standards, and solicits 
    detailed suggestions concerning which existing regulations need to be 
    changed to be consistent with HACCP, and how those regulations should 
    be changed. The Agency notes that several individuals and groups, 
    including at least one trade association, responded to a similar 
    request in the February 3, 1995, proposal. FSIS would also appreciate 
    comments on the economic burdens and the paperwork, recordkeeping, or 
    other information collection burdens associated with the regulations 
    discussed in this document.
        Comments supported by scientific or other data on the impacts, such 
    as the public health effects, of changing or eliminating existing 
    regulations, would be especially valuable.
    Executive Order 12866
        This advance notice of proposed rulemaking has been reviewed under 
    Executive Order 12866. This rule has been determined to be significant 
    for the purposes of Executive Order 12866 and, therefore, has been 
    reviewed by the Office of Management and Budget.
        FSIS does not have data necessary to assess how the regulatory 
    changes discussed in this document might affect various sectors of the 
    meat and poultry industries. Therefore, the Agency invites comment on 
    potential effects, including economic costs or benefits, of any 
    specific changes that may be suggested.
        Done, at Washington, D.C., on December 21, 1995.
    Michael R. Taylor,
    Acting Under Secretary for Food Safety.
    [FR Doc. 95-31393 Filed 12-26-95; 3:36 pm]
    BILLING CODE 3410-DM-P
    
    

Document Information

Published:
12/29/1995
Department:
Food Safety and Inspection Service
Entry Type:
Proposed Rule
Action:
Advance Notice of Proposed Rulemaking; Request for Comments.
Document Number:
95-31393
Dates:
Comments must be received on or before February 27, 1996.
Pages:
67469-67474 (6 pages)
Docket Numbers:
Docket No. 95-008A
RINs:
0583-AB89: FSIS Agenda for Change: Regulatory Review; Food Standards
RIN Links:
https://www.federalregister.gov/regulations/0583-AB89/fsis-agenda-for-change-regulatory-review-food-standards
PDF File:
95-31393.pdf
CFR: (1)
9 CFR 318.10.)