[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]



=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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:
    <bullet> Despite efforts to prevent this, has FSIS issued 
duplicative or redundant 

[[Page 67472]]
requirements? Do FSIS' information and recordkeeping requirements 
overlap with those of other Federal, State, or local agencies?
    <bullet> Should individual FSIS forms be modified or combined? If 
so, how?
    <bullet> Should FSIS allow respondents to use facsimiles, 
computers, or other automated collection systems or information 
transfer technologies? If so, for which information requirements?
    <bullet> Would it be helpful for FSIS to accompany information 
requirements with format suggestions?
    <bullet> Generally, how might FSIS make information collection 
activities less burdensome?

Current Activity

    FSIS has decided to publish the following documents at this time:
    <bullet> 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);
    <bullet> 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;
    <bullet> 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
    <bullet> 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

    <bullet> Review of all prior-approval regulations not addressed in 
the above-mentioned documents, with related rulemaking proposals 
projected for publication during 1996;
    <bullet> 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:
    <bullet> Definitions (Secs. 301.2 and 381.1);
    <bullet> Inauguration, suspension, and withdrawal of inspection 
(Secs. 305.4, 305.5, and 381.19-381.21, and 381.29);
    <bullet> Appeals procedures and related administrative procedures 
(Secs. 306.5, 335.40, and 381.35);
    <bullet> Reinspection of product entering establishments, and 
retention and disposition of product (Secs. 318.2 and 381.145);
    <bullet> 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
    <bullet> 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 

[[Page 67473]]
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.)                      

[[Page 67474]]
                                                                                                                
                                                                     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