FSIS Agenda for Change: Regulatory Review

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

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Regulations--FMIA, PPIA Subject Possible action

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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.

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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]

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