Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) SystemsIssue Papers

SUMMARY: On September 13-15, 1995 and September 27-29, 1995, the U.S.

Department of Agriculture held issue-focused public meetings on the

Food Safety and Inspection Service's (FSIS) proposed rule, ``Pathogen

Reduction, Hazard Analysis and Critical Control Point (HACCP)

Systems.'' At the meetings, FSIS made available issue papers on agenda

topics. Those issue papers are published in this notice.

DATES: The comment period for the proposed rule, ``Pathogen Reduction;

Hazard Analysis and Critical Control Point (HACCP) Systems'' (60 FR

6674, February 3, 1995), which reopened August 11, 1995 (60 FR 41029

August 11, 1995), will close, as announced in the Federal Register (60

FR 45380, August 31, 1995), on October 30, 1995.

ADDRESSES: Send an original and two copies of written comments to: FSIS

Docket Clerk, DOCKET 93-016P, Docket Room 4352, South Agriculture

Building, Food Safety and Inspection Service, U.S. Department of

Agriculture, Washington, DC 20250.

FOR FURTHER INFORMATION CONTACT: Dr. Paula Cohen, Director, Regulations

Development, Policy Evaluation and Planning Staff, FSIS, USDA, Room

3812, South Agriculture Building, Washington, DC 20250, (202) 720-7164.

SUPPLEMENTARY INFORMATION: The U.S. Department of Agriculture held

issue-focused public meetings on September 13-15, and 27-29, 1995, on

FSIS' proposed rule, ``Pathogen Reduction; Hazard Analysis and Critical

Control Point (HACCP) Systems.'' The purpose of the meetings was to

provide an opportunity for interested persons to directly discuss the

key concerns that were raised during the comment period on the proposed

rule, as well as the Agency's thinking about options under

consideration in response to those concerns.

For the meetings, FSIS prepared brief issue papers on agenda items

that were discussed. The issue papers are: Issue Paper 1. ``Regulatory

Shift to Performance Standards--`Layering';'' Issue Paper 2. ``Overview

of HACCP Proposal FSIS Oversight of HACCP Changing Role of Inspectors

Under HACCP;'' Issue Paper 3. ``Pathogen Reduction Performance

Standards;'' Issue Paper 4. ``Carcass Cooling Standards for Red Meat

and Poultry;'' Issue Paper 5. ``Specific Economic Considerations and

Issues;'' Issue Paper 6. ``Specific Product Considerations Involving

Religious, Ethnic, and Cultural Food Handling Practices;'' Issue Paper

7. ``Antimicrobial Treatments in Slaughter Plants;'' and Issue Paper 8.

``Specific Product Considerations Involving International Trade.''

All information received at the issue-focused meetings and received

during the reopened comment period will be considered in the

development of the final rule for Pathogen Reduction/HACCP. FSIS is

publishing the issue papers so they will be available to persons who

were unable to attend the issue-focused public meetings and to enhance

the opportunity for comments from all interested parties.

The issue papers are published below.

Issue Paper 1. ``Regulatory Shift to Performance Standards--

`Layering'''

I. Objective of Proposal

The goal of the Pathogen Reduction/HACCP Proposed rule is to adopt

and implement an integrated, HACCP-based inspection system that

clarifies and maintains a distinction between industry and FSIS

responsibilities, targets the most significant hazards, and fosters

flexibility, innovation and accountability for improving food safety.

However, FSIS recognizes that to achieve this goal, it must also

eliminate unnecessary and redundant regulations.

II. Description of Comments

Some commenters argued that the proposed pathogen reduction and

HACCP requirements layer an additional set of regulations, and

subsequently an additional program of inspection, on the current meat

and poultry inspection regulations and inspection activity. Some

commenters recommended that, prior to publishing the final rule, FSIS

review and revise or eliminate current regulations, directives, and

other FSIS guidances so that they are compatible with the proposed

pathogen reduction/HACCP requirements.

Some commenters cautioned FSIS not to alter or eliminate current

regulatory requirements and inspection procedures until more effective

ones are operating in their place.

III. Issues Raised by Comments

FSIS recognizes the need to articulate how regulatory requirements

and inspectors' roles would change under the regulatory system that

would emerge from the proposed regulatory reforms. Key issues of

concern raised by the comments include:

HACCP clarifies the mutually exclusive roles of

industry and Government and, along with responsibility, affords

individual plants the flexibility to innovate and make site-specific

decisions. The current inspection system makes the inspector

responsible for ``approving'' production-associated decisions. How

will inspection change under HACCP?

Under what circumstances will FSIS continue to issue

command-and-control-type requirements?

How should the regulatory system be changed, and at

what pace, to eliminate redundant and obsolete requirements, such as

prior approval systems and command-and-control requirements?

Has FSIS identified the regulations that need to be

eliminated or changed to be compatible with HACCP? Given that the

current inspection system is embedded in current regulations, the

essential changes are likely to be extensive. Can all necessary

changes be adopted prior to HACCP implementation?

Will inspectors' roles change as a result of the shift

from step-by-step, command-and-control requirements to performance

standards? How? How will the transition to the new regulatory

system--with plants accountable for meeting FSIS's requirements by

methods not necessarily listed in the regulations or inspectional

guidelines--be managed?

What methods of dispute settlement should be available

to handle the more

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complex decisions that need to be made about compliance with

regulations under HACCP?

IV. FSIS Current Thinking About Changes Needed to Address These Issues

Under the proposal in conjunction with the regulatory reforms now

in progress, industry would assume full responsibility for production

decisions and execution, and FSIS, having set food safety standards and

public health objectives, would monitor and enforce plants' compliance

with those standards and related requirements and, under HACCP, would

verify process control. This would appear to imply the following:

FSIS must review and revise or eliminate current

regulations, directives, and other FSIS guidances to ensure their

compatibility with HACCP requirements and the regulatory philosophy

HACCP represents.

Performance standards could be used to eliminate

certain command-and-control requirements.

With the distinct roles and responsibilities of FSIS

and industry clearly defined, FSIS would be able to relieve

inspectors of many tasks that should be performed by establishments,

enabling inspectors to focus on, HACCP-related oversight tasks.

In-plant inspection would have to be managed so that

the skills necessary to evaluate the plant's performance under HACCP

would be available in every plant.

Lines of FSIS supervision and decision making would

need to be shortened, clarified, and publicized, particularly with

respect to fair, prompt, and effective dispute resolution.

Unnecessary and redundant regulations would need to be

eliminated.

Issue Paper 2. ``Overview of HACCP Proposal FSIS Oversight of HACCP

Changing Role of Inspectors Under HACCP''

I. Objective of Proposal

The proposed rule embraced the recommendations of the National

Advisory Committee on Microbiological Criteria for Food (NACMCF)

concerning ``The Role of Regulatory Agencies and Industry in HACCP.''

Regarding food safety, the NACMCF advised that establishments operate

effective HACCP systems, with the government focusing on verification

that HACCP plans are working as intended. The Agency's stated intent

was to review and revise existing inspection tasks to assure they are

focused on the critical control points in HACCP plans. These revised

tasks would be incorporated into the Performance Based Inspection

System (PBIS) and become part of regular assignments.

FSIS inspectors would play a verification role to ensure that

appropriate HACCP plans are in place, are being implemented properly,

and are achieving the desired food safety results. This role would

require increased activity by FSIS inspectors in the areas of record

review, visual process verification, and product sampling. FSIS

inspectors would have to develop new skills to carry out these

activities within the HACCP framework.

II. Description of Comments

Commenters generally supported the need for government to maintain

oversight of meat and poultry production to ensure that industry is

using a system of process control that assures safe product. Some

commenters stated government needs to relinquish at least some of the

role it plays in making decisions about the production process itself;

that is, industry should have the responsibility for deciding how meat

and poultry products are produced, provided it can demonstrate that it

is maintaining process control at the level necessary to produce a safe

product, and meets other regulatory requirements. There was general

support for HACCP as an acceptable industry process control mechanism,

though commenters raised a number of issues concerning specific

provisions of the proposed rule. Some commenters stated government

requirements should be scientifically supportable and stated as non-

prescriptively as possible (as performance standards).

Commenters also raised concerns about the amount of discretion

inspectors would have to suspend plant operations due to alleged

deficiencies in either the design or operations of a HACCP plan. They

expressed concern about the limited amount of procedural due process

afforded to establishments faced with suspended operations due to an

inspector's judgment on the adequacy of their HACCP program. Some

commenters objected to the proposed hearing process and requested a

more expedient way to resolve disputes before requiring suspension of

operations or withdrawal of inspection. Some urged the Agency to make

clear to inspectors that such extreme actions are to be reserved for

only those situations in which continued operation of the establishment

presents an imminent public health risk. Finally, commenters raised

questions concerning the uniformity and depth of HACCP training

inspectors should receive.

Some commenters, while supporting the enhancement of industry's

responsibility for food safety that is embodied in HACCP and

performance standards, expressed concern about how plants would be held

accountable for meeting their enhanced food safety responsibilities.

These commenters called for vigorous inspectional oversight of HACCP

including substantial microbial sampling and testing by FSIS to verify

HACCP and enforce performance standards. Some commenters called for

retaining current inspection procedures until HACCP is implemented and

FSIS can have confidence that alternative procedures will be more

effective than current ones. To increase industry accountability, some

commenters called for clear delineation of the plant's legal

obligations under HACCP, public access to HACCP records, and

whistleblower protection for plant and FSIS employees.

III. FSIS Current Thinking on Selected Issues

FSIS recognizes the need to articulate in more detail how FSIS

oversight of meat and poultry production operations under a HACCP

process control system will change, how FSIS regulatory roles will be

altered, and how these changes will affect inspectors' roles. The

following issues must be addressed to develop and implement a final

rule:

How will FSIS oversee a plant's operation under HACCP,

compared with the current system.

How should inspector roles be changed to distinguish

between industry and government responsibilities.

How should the inspector's role and priorities be

redefined to focus on the greatest public health risks.

A. Transition to a System Focusing on Industry Process Control and

Other Systems and Safety Standards

The regulatory environment envisioned by the proposed rule, in

which industry would operate under a process control system (HACCP) and

inspection personnel would ensure that HACCP is working by overseeing

the effectiveness of that process control system in producing safe

product and by enforcing performance standards and other requirements,

calls for a significant shift in FSIS oversight. This shift would focus

regulatory activities on process control and other systems and the

enforcement of government safety requirements (to the extent possible

issued as performance standards) rather than on prescriptive measures

for controlling industry production practices.

The implementation of the proposed requirements would significantly

change the roles and responsibilities of Agency personnel performing

in-plant

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regulatory activities. Inspection roles and responsibilities would

shift from DETECTING facility and production problems to VALIDATING and

VERIFYING that plants are producing safe meat and poultry products that

meet the newly established requirements.

Agency activities and individual inspectors' tasks would need to

reflect these proposed new requirements, and would need to be timed to

conform to the phase-in schedule for the new requirements. During the

transition from the current inspection system to the system envisioned

by the proposal, it would be critical to provide for an interface

between what FSIS is presently doing and what the Agency would be doing

when initial implementation of these requirements occurs. Therefore,

FSIS' current thinking about how inspection will change entails

determining how existing and familiar systems may be used to support

the transition, while the Agency prepares inspectors and supervisors

for their changed roles under the new program.

Inspection roles are envisioned to consist of three primary

activities--validation, verification, and enforcement. Inspection

validation activities would include assessments of whether plants

comply with the specific elements of the regulation and that HACCP

systems encompass all seven HACCP principles. Inspection verification

activities would include an evaluation of records to verify that the

establishment is complying with its written HACCP plan along with in-

plant visual observations, microbial testing, and other inspectional

tasks to ensure that HACCP is being properly implemented and

performance standards are being met.

Formal enforcement actions, including retention of products or

suspension of operations, would be instituted when inspection personnel

identify and document occurrences of direct product contamination,

insanitary conditions where the product may have become adulterated or

contaminated or where it may have been rendered injurious to health, or

failure of the HACCP plan. Lines of supervision and decisionmaking

would be shortened and clarified with respect to dispute resolution.

FSIS recognizes that the appeal process must be more expeditiously

handled under the proposed program.

Inspection activities would be accomplished within the framework of

existing support systems. For example, the Performance Based Inspection

System (PBIS) would serve as the primary vehicle to schedule, record,

and report all validation and verification tasks. The PBIS corrective

action system, which consists of the deficiency classification guide

and process deficiency record, would be used to identify, document, and

act upon occurrences of direct product contamination and system

failures. The system would be modified to incorporate all slaughter-

related activities, except carcass-by-carcass inspection.

The movement to a HACCP work environment would represent the most

significant change to the regulatory process in the history of the

inspection program. This would require that the field work force be

trained to understand and perform new work tasks and to adapt to the

changing regulatory focus. The initial training would focus on three

aspects--(1) to equip employees to handle the regulatory tasks

associated with the near term initiatives such as verifying the SOP

records; (2) to equip employees to understand and appreciate the

cultural changes that will take place in a HACCP work environment its

effects on their actions; and (3) to equip front line supervisors to

lead the cultural change. Subsequent training would be provided on a

sequential basis to correspond with the HACCP phase-in schedule. In

this way, inspectors would be able to directly apply ``just learned''

knowledge and procedures within days of receiving training. Training

would be delivered by Agency personnel at the local level, using

standardized materials developed expressly for that purpose.

FSIS shares the objective of some commenters of ensuring that

inspectors and plant employees are given a common understanding and

approach to HACCP and its application to meat and poultry production.

However, FSIS believes it must place full reliance on its inhouse

training delivery capabilities rather than participate in joint

training sessions with industry personnel at the local level. Given the

logistics and timeframes involved in training Agency personnel, the

Agency could not accommodate the additional burden of coordinating its

training delivery activities with industry. FSIS is, however, committed

to sharing its curricula with interested parties, in order to ensure

that the scientific and technical principles which undergird HACCP are

viewed consistently.

B. Other Changes Beyond the Transition to HACCP

Along the farm-to-table continuum there are several opportunities

for Federal, State, and local government regulators to foster or

establish standards so industry can reduce the possibilities for

product adulteration and subsequent foodborne illness.

For animal production, producer associations could promote the

development of quality assurance programs that focus on risk reduction

strategies for pathogen control in live animals. Further research by

government, industry, and the scientific community is also necessary to

acquire the scientific information about pathogen colonization, its

characterization, prevalence, and incidence in animal populations,

which is necessary for designing effective intervention programs.

For transportation and storage, industry associations could

promote, and individual transportation and storage firms could adopt,

special systems for handling meat and poultry that ensure minimal

growth of pathogenic organisms. Development of Good Manufacturing

Practices (GMP's) for this sector to address problems such as

sanitation and temperature control and periodic reviews to determine

conformance with such GMP's are also envisioned. These reviews would

provide the basis for determining rates of industry compliance.

In the retail and restaurant sector, FSIS would continue its

ongoing, direct regulatory authority over adulterated and misbranded

product. This would include product control actions, such as voluntary

destruction, detention, and judicial seizure. It also would include the

issuance of letters of warning and referrals to the Department of

Justice for injunctions or criminal action.

FSIS would expand its support to State and local inspection and

enforcement agencies by: (1) Supporting the development and adoption of

model food codes; (2) facilitating the standardization of state and

local enforcement protocols in concert with the Food Code; and 3)

evaluating state and local food regulatory agency inspection and

enforcement programs for meat and poultry processing and handling.

In the area of food handler and consumer education, FSIS would

continue its current program and would seek ways to expand its

collaboration with all interested parties in government, industry and

other private organizations to foster the effective delivery of safe

handling messages to consumers in a manner that would improve safe food

handling practices.

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Issue Paper 3. Pathogen Reduction Performance Standards Microbial

Testing

I. Objective of Proposal

The objective of the proposed interim targets for pathogen

reduction and daily microbial testing requirement is to establish a

measure of accountability for adopting process controls in slaughter

plants and plants producing raw ground product that effectively control

and reduce harmful bacteria on raw products. Salmonella has been

selected in the proposed rule to serve as both an indicator of process

control and as the basis for a pathogen-reduction performance standard.

II. Description of Comments

The two issues most commonly addressed by the commenters concerning

the proposed microbial testing requirements were the proposed selection

of Salmonella as the indicator organism and the frequency of proposed

testing. Commenters generally supported the concept of HACCP-based

process control and the goal of reducing harmful bacteria on raw

products.

Some commenters supported the proposed use of Salmonella as the

indicator organism because it is a leading cause of foodborne illness,

and, among common enteric pathogens, it is among the most prevalent and

relatively simple tests are available to detect it.

Some commenters opposed the use of Salmonella as the indicator

organism because its low incidence in beef makes it a poor indicator of

pathogen reduction in that species; the yes/no test result is a weak

measure of process control; and, compared to some non-pathogenic

alternatives such as generic E. coli, Salmonella tests are more

difficult, time-consuming and costly. Some commenters recommended FSIS

consider an alternative indicator organism such as generic E. coli as a

preferable process control indicator organism because it can serve

effectively in all species as an indicator of fecal contamination.

Some commenters recommended retaining Salmonella as the target or

performance standard for pathogen reduction but adding a requirement

for E. coli testing because it is a preferable tool for verifying

process control. Some commenters recommended requiring testing for

additional pathogens in selected species or products based on the

degree of public health risk posed by the pathogen. With regard to

sampling frequency, some commenters supported the one sample per day

testing requirement as an efficient means of verifying process control.

The comments received on the frequency of testing centered upon

suggestions on the sampling frequency of one test per day for each

species and for raw ground product. A sampling protocol based on

production volume or product risk was suggested as an alternative. Some

commenters opposed the proposed testing requirement stating that it was

inadequate to verify process control reliably and recommended more

frequent testing that would be more representative of a plant's

production. Some commenters recommended basing the frequency of testing

on a plant's volume of production and argued that the proposed sampling

frequency and moving sum statistical procedure would allow a lack of

process control to go undetected for excessive periods.

Some commenters criticized the proposed frequency, noting the cost

burden of the testing and its financial impact on businesses,

especially for small volume plants and plants producing multiple

species and multiple ground products that would require multiple tests.

Some commenters recommended less than daily testing or other changes to

minimize the financial impact on small business.

Some commenters objected to the proposed test sample collection

methodology, including the sample size. Recommendations included

adopting the same sample size for all species. Some commenters

preferred swab samples to samples taken by knife cuts.

Some commenters stated that proposed end product testing is

inconsistent with HACCP principles and that establishments should

decide for themselves through hazard analysis whether testing is needed

and at what frequency.

III. FSIS Current Thinking on Selected Issues

The concepts of process control, microbiological testing to verify

process control, and the establishment of practical measures of

accountability for controlling and reducing harmful bacteria on raw

products remain central to the FSIS food safety strategy. Based on the

comments related to microbial testing, FSIS reviewed whether the

pathogen reduction objectives of the rule can be accomplished without

requiring near-term microbial testing. FSIS considers some appropriate

approach to testing to be necessary as the means of ensuring that every

establishment is working toward an acceptable level of pathogen

control. The key issues raised by the comments involve how best to

implement these concepts.

Relative to concerns about reducing the burden of testing, the

Agency is reviewing: (1) The organism to be selected in testing; (2)

the necessity for daily testing in every plant, including plants that

grind raw meat and poultry obtained from other plants and (3) the

necessity for testing each species slaughtered and each ground product

produced.

The proposed rule relied on Salmonella as both a process control

indicator and as the basis for a pathogen reduction performance

standard applicable to all species. Based on the comments, FSIS is

seriously considering generic E. coli as the process control indicator

organism and the adoption of a quantitative E. coli standard as a

measure of process control with respect to the prevention and reduction

of fecal contamination in slaughter plants.

If FSIS moves to a quantitative E. coli standard as the means of

verifying process control, the Agency will also need to resolve what

the standard should be (i.e., the number of organisms).

FSIS continues to regard microbiological testing to verify process

control to be an establishment's responsibility. FSIS is reconsidering

the proposed one test sample per day requirement based on comments

questioning both its adequacy and its cost impact on small plants. FSIS

is considering alternatives that are based on the volume of production.

FSIS is also considering alternatives that would reduce the cost impact

of testing on very small-volume plants producing multiple species and

multiple products.

FSIS is considering the adoption of pathogen-specific performance

standards as a direct measure of accountability for controlling and

reducing harmful bacteria on raw meat and poultry products. For

example, the proposed interim targets for pathogen reduction based on

Salmonella (or possibly other pathogens for specific species) could be

adopted as performance standards and enforced by FSIS through its own

compliance monitoring. Establishments not consistently achieving the

targets would be required to take corrective action and could be

subject to other regulatory action, as appropriate.

Issue Paper 4. Carcass Cooling Standards for Red Meat and Poultry

I. Objective of Proposal

The objective of the proposed carcass-cooling requirements as a

near-term measure in the Pathogen Reduction/HACCP proposed rule is to

ensure that establishments effectively control the

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growth of pathogens on meat and poultry carcasses.

II. Description of Comments

Commenters generally supported the need for slaughter plants to

chill carcasses as a means of minimizing the growth of harmful

bacteria, but some commenters questioned the need for any new near-term

regulatory requirements for carcass cooling. These commenters

recommended instead that plants address carcass cooling as part of

their HACCP plan at the time they implement HACCP. Some commenters

opposed the ``command and control'' nature of the proposed requirements

and said that relying instead on the incorporation of time and

temperature controls in a plant's HACCP plan would provide maximum

flexibility to adopt controls consonant with different products and

environments.

Some commenters raised concerns about the specific time and

temperature requirements in the proposed rule. Other comments included

the pros and cons of surface versus internal temperatures as indicators

of coldness. Some commenters supported the time and temperature

requirements as proposed, noting that these controls are designed to

minimize the potential multiplication of bacterial pathogens in

carcasses and raw meat products and thus reduce consumer exposure to

pathogenic bacteria. Some pointed out that the technology is available

and generally being used in plants and that, furthermore, the proposed

time and temperature controls are generally being adhered to by many

establishments and therefore should not be an overwhelming burden.

These commenters stated that the cooling rate proposed by FSIS is based

on the best estimate of what is needed to minimize multiplication of

pathogenic organisms and what is achievable in a well-controlled meat

and poultry establishment.

Some commenters raised concerns about not having the cooling

capacity to comply with the proposal and about the prohibitive cost of

obtaining the necessary refrigeration equipment. Commenters advocated

more realistic requirements that take into consideration plant/product

variety, different processing operations, and diverse shipping and

receiving norms. Commenters raised questions about disposition of

product that did not meet temperature requirements.

Some commenters expressed concern about health problems that could

result among their employees from working in a cold environment.

Comments related to worker comfort and safety cited studies that

concluded many human physical ailments are created or aggravated by

cold temperatures. Worker safety was also cited as an issue on the

ground that the difficulty of handling and cutting meat at such cold

temperatures increases the potential for accidents.

III. FSIS' Current Thinking on Issues Raised by Comments

FSIS considers carcass cooling to control growth of pathogens to be

a basic element of a safe food production process. Poultry slaughter

plants are currently subject to an FSIS directive on carcass cooling,

and many beef slaughter plants take appropriate measures to cool

carcasses. FSIS continues to believe there is a need before and after

implementation of HACCP for the establishment of some basic standards

that can be used to ensure all plants meet carcass cooling standards.

FSIS recognizes the need to take a practical approach that

acknowledges the diversity of production practices affected by carcass

cooling requirements. FSIS is considering more flexible alternatives to

the time and temperature requirements in the proposed rule, including

adoption of pathogen growth performance standards (see options below).

FSIS acknowledges the need for a clarification of product

disposition options for product that does not meet carcass cooling

requirements. This remains under consideration.

IV. Options for Change

In addition to the currently proposed requirements, FSIS is

considering the following options:

Maintain the proposed requirements but raise the

40 deg.F criterion to the highest level that would maintain the

pathogen control objective and address at least some concerns about

worker comfort and safety and equipment costs. The European Union,

for example, uses a 44.6 deg.F standard for red meat to control

pathogens during slaughter operations.

Establish a carcass cooling performance standard

expressed as a maximum acceptable level of pathogen growth.

Rely on microbiological targets, such as the proposed

interim targets for pathogen reduction, as performance standards,

monitored by periodic microbial testing, and have no specified

cooling requirements. This option would provide establishments

flexibility to use carcass cooling methods that meet their own needs

as long as they meet the end product performance standard.

Issue Paper 5. Specific Economic Considerations and Issues

I. Objective of Proposal

The Pathogen Reduction/HACCP proposal acknowledged that the

proposed requirements would have significant economic impact,

particularly on small entities. Comments were requested on cost

estimates for these impacts as well as on alternative regulatory

approaches that could lessen this economic impact.

II. Description of Comments

Several themes emerged from the written comments received and oral

statements made during public meetings on the Pathogen Reduction/HACCP

proposed rule. A primary concern was that the proposal would have

severe negative economic impacts on small businesses. Some commenters

opposed mandatory HACCP, daily microbial testing, and stringent time

and temperature requirements.

While most commenters supported HACCP in principle, small

businesses expressed concern about hazard analysis and plan development

costs, equipment purchases, plant personnel training, and records

maintenance. Suggested alternatives included voluntary HACCP, a 5-year

implementation period, increased financial and technical support,

alternative training options, inplant demonstration projects and

generic HACCP plans.

Daily microbial testing of carcasses from each species slaughtered

and of each type of raw ground product was cited as an unfair burden on

small plants that slaughter only a few animals, a variety of species,

or produce several different raw ground products. Some commenters

proposed a frequency of microbial testing based on production volume or

simply once per week or month in small plants. It was also suggested

that federally-subsidized laboratories conduct the testing, an

indicator organism instead of Salmonella be selected, and that either

FSIS inspectors or, in the case of State-inspected plants, State

inspectors conduct the sampling.

In response to the proposed carcass cooling time and temperature

mandates, small businesses voiced a need for more realistic standards

that reflect small plant product variety, processing operations, and

shipping norms. Some said they would need to purchase additional

refrigeration equipment for compliance with the proposed requirements.

Others cited the ``command and control'' nature of these proposed

standards and argued that

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they are impractical restrictions on a variety of their operations. A

common theme was that these proposed controls should be restated as

guidelines.

Commenters also voiced economic objections to the antimicrobial

treatments and asked for greater scientific justification. Comments

also included cautions about worker safety and environmental hazards,

and requested a change from mandatory to voluntary implementation.

Some commenters asserted that within the small plant category is a

subgroup of State-inspected plants with the same concerns as those

stated above and additional ones due to their very small size and

diverse operations. These commenters requested identification of a

``very small'' sub-category of plants defined as those with annual

sales less than $1 million, fewer than 20 employees and limited

production volume. Exemptions and implementation delays were requested

for plants in the proposed ``very small'' category.

Another issue raised was State-provided implementation assistance

for State-inspected plants and whether matching Federal funds would

cover State programs that provided more help than USDA regulations

required.

III. Issues Raised by Comments

After reviewing the small business concerns expressed in the

comments, FSIS is considering whether the food safety and public health

objectives of this proposal can be accomplished by means that would

reduce the regulatory burden and resulting costs of the proposed

requirements on small businesses.

FSIS continues to believe that mandatory HACCP is central to the

FSIS food safety strategy and reform of the meat and poultry inspection

system. Given this, can FSIS significantly reduce the economic impacts

on small business by any of the generally applicable modifications to

the proposed rule or by using its available resources to provide

implementation assistance?

For example, small business objections to the burden of daily

microbial testing of each species and ground product for Salmonella

require FSIS to determine whether another microorganism, reduced

frequency of testing, and/or FSIS assumption of a greater testing role

would be equally effective in verifying process control and attaining

pathogen performance standards and, at the same time, reduce the

economic burden.

Raw product time and temperature specifications and antimicrobial

treatments for carcasses are techniques for pathogen reduction that

have been criticized as command-and-control regulatory approaches. FSIS

is considering whether these proposed requirements can be replaced by a

performance standard or otherwise modified to achieve the food safety

objectives while mitigating the economic burden on industry, including

small plants.

After publication of final Federal meat and poultry Pathogen

Reduction/HACCP regulations, all State inspection programs must

establish requirements at least equal to the Federal requirements. Due

to variations in State regulatory processes, some intrastate inspection

programs may match the Federal regulations within a year while others

may take two years in cases where inspection program regulations must

be approved by the State legislature. Once new regulations are in

place, State plants would have to be given adequate time to meet the

new requirements. In particular, State implementation of the near-term

initiatives would likely occur on a longer time line than that proposed

for Federal plants. FSIS is considering ways to minimize any inequity

between Federal and State-regulated plants.

Another State-specific concern relates to Federal matching funds

for up to 50 percent of State inspection program budgets. The HACCP

proposal raises questions about what activities will be covered by

matching funds. For example: If State inspection programs provide HACCP

training for industry employees in State plants, assist State plant

owners in HACCP plan development and implementation, or offer ongoing

technical assistance to State plant operators, can/shall Federal

matching funds be provided?

A further question is whether certain small businesses should be

separately identified from others by defining a new ``very small''

business category. Available data indicate, for example, that among all

state-inspected plants, approximately 75 percent employ fewer than 8

employees. Given the likelihood of longer implementation times for most

intrastate plants due to the normal process of State compliance with

Federal inspection program changes, is there a reasonable justification

for longer times for all such ``very small'' plants in terms of

attainment of national pathogen reduction and process improvement

requirements?

IV. FSIS' Current Thinking on Issues Raised by Comments

To address small business concerns, FSIS proposes to use a three-

part regulatory policy that would apply to every Federal and State-

inspected plant: (1) Fundamental public health and food safety

principles must not be compromised, (2) Regulatory flexibility will be

provided to plants by establishing performance standards, and (3)

Direct and indirect assistance will be provided by FSIS to small plants

that need help in reaching those goals.

FSIS is considering appropriate regulatory flexibility options that

would minimize small business impacts as they attain performance goals.

In the other issue papers on carcass cooling requirements,

antimicrobial treatments, and microbial and testing standards, FSIS has

outlined alternatives that could mitigate both the technical and

economic considerations raised by small businesses about these proposed

requirements. Remaining concerns to be addressed are focused on the

HACCP implementation schedule and technical assistance.

HACCP Implementation Schedule

As noted above, FSIS is considering ways to adjust the

implementation schedule to ensure that small businesses under Federal

regulation and those under State regulation are treated equitably with

respect to the time period allowed for compliance with the provisions

of the final rule.

HACCP Implementation Assistance

Federal Assistance to Industry: FSIS is considering a program to

develop implementation aids that should greatly reduce the uncertainty

small plants have expressed about a mandatory HACCP program. These aids

would include: (1) Information publications, such as a HACCP Handbook

that explains how a plant can effectively and economically incorporate

the seven HACCP principles into its operations; (2) training videos and

computer programs that present HACCP implementation guidance in

alternative formats; (3) models for onsite HACCP training of plant

employees; and (4) a catalog of hazards with examples of control

measures and generic plans for each slaughter and processing category

described in the proposed rule. These materials would provide the means

for all plants to meet HACCP regulatory requirements. FSIS is also

planning to sponsor inplant demonstration projects to generate real-

world information and guidance about near-term and HACCP implementation

issues in small businesses.

Federal Assistance to States: FSIS would continue its technical

assistance to State programs by including State training officials in

Federal training efforts, by facilitating State access to and

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use of Federal computer support systems, and by expansion of state/

federal cooperative efforts through the Conference for Food Protection,

the National Association of State Departments of Agriculture, the

Association of Food and Drug officials, and the Meat and Poultry

Inspection Advisory Committee. Also, FSIS' plans for inplant

demonstration projects referenced above would focus on small plants

under State regulation as well as those under Federal regulation.

Issue Paper 6. Specific Product Considerations Involving Religious,

Ethnic, and Cultural Food Handling Practices

I. Objective of Proposal

The objective of the Pathogen Reduction/HACCP proposed rule is to

take a comprehensive approach to improving the safety of meat and

poultry products.

II. Description of Comments

Many commenters identified unique product considerations that they

felt were threatened or undermined by certain requirements in the

proposed rule. These unique product considerations principally involved

religious, ethnic, and cultural issues centered around three product

types: kosher products, Chinese poultry, and ``hot'' specialty items

usually for Moslem, Chinese, Hispanic, and Hawaiian markets.

Comments related to kosher products identified two specific areas

of concern. First, antimicrobial treatments would cause a serious

problem under kosher dietary laws if applied before the salting process

and would cause practical problems if applied after the salting

process. Second, the time and temperature requirements for carcass

cooling might significantly shorten the available time for ritual

salting, particularly for religious holidays, which might limit the

availability of kosher meat. For these reasons, commenters requested

exemptions from using antimicrobial treatments and from following

proposed time and temperature requirements for meat and poultry

products that are certified and sold as kosher.

The Chinese-American community expressed concern about the added

cost of whole birds prepared for religious purposes. Commenters

requested an exemption for such products.

Other commenters noted that proposed time and temperature

requirements for carcass cooling conflict with ``hot pork,'' a process

during which hogs are slaughtered and delivered to customers in some

ethnic markets with little or no chilling. A similar process is used

with lamb, goat, and beef for Moslem customers. An exemption was also

requested for these products.

III. FSIS' Current Thinking on Issues Raised by Comments

FSIS is examining how it can provide the regulatory flexibility

needed to adequately address the concerns noted above and still achieve

its food safety and public health objectives.

FSIS expects the final rule to contain changes that will as a

general matter increase industry's flexibility to use alternative

technologies and procedures which reduce and control pathogens to meet

the microbial performance standards. This approach may help address

some of the concerns expressed by religious and cultural groups. If any

individual group's unique problems are not adequately addressed by this

approach, the agency would consider other alternatives that respect

well established religious, ethnic, and cultural practices as much as

possible while assuring fundamental public health and food safety

objectives are achieved.

Issue Paper 7. Antimicrobial Treatments in Slaughter Plants

I. Objective of Proposal

The objective of the proposal in the Pathogen Reduction/HACCP

proposed rule, to require the application of at least one effective

antimicrobial treatment in slaughter plants, is to establish a minimum

standard of care regarding the use of available technology to reduce

pathogens on carcasses leaving slaughter plants and to gain a net

reduction in the occurrence of pathogens on carcasses in the near term,

while HACCP is being implemented.

II. Description of Comments

Some commenters supported the proposal to mandate the use of at

least one antimicrobial treatment, subject to reservations concerning

the effectiveness of the available treatments for specific pathogens,

the possibility of cross-contamination, and the need to maintain

careful, hygienic slaughter practices.

Some commenters opposed the proposed antimicrobial treatments,

raising concerns about the ``command and control'' nature of the

proposal and the lack of sufficient empirical data to justify mandatory

antimicrobial treatments.

To alter the ``command and control'' nature of the proposal, some

commenters recommended eliminating the formal approval process for

antimicrobial treatments and allowing any treatment that meets stated

conditions (such as, ``meets a pathogen reduction standard,'' ``does

not adulterate product, create insanitary conditions, or result in

misbranded product.'') Other suggestions included accepting irradiation

and salt as antimicrobial alternatives. Some commenters stated that use

of antimicrobial treatments should be a control measure plants consider

during HACCP plan development, not before.

Some commenters noted that certain foreign countries do not permit

antimicrobial treatment of meat and poultry products. Acknowledging the

proposed exemption for exported product included in the proposed rule,

commenters still expressed concern that it was impractical for a

slaughter operation to separate domestic and export product.

III. FSIS' Current Thinking on Issues Raised by Comments

FSIS continues to believe antimicrobial treatments in many

slaughter plants play an important role in a pathogen reduction

strategy. FSIS is reconsidering whether the proposed across-the-board

mandate is the optimal approach to fostering adoption of appropriate

antimicrobial technologies or whether more flexible alternatives,

including reliance on end-product performance standards, would be

equally or more effective.

IV. Options for Change

FSIS is considering the following possible alternatives to the

proposed antimicrobial treatment requirements:

Adopt the near-term requirement for slaughter

establishments to apply an antimicrobial treatment to meat and

poultry carcasses, with modification of some technical details (such

as timing application, and proposed requirements for ensuring the

efficacy of specific treatments).

Adopt the near-term requirement for slaughter

establishments to apply an antimicrobial treatment to meat and

poultry carcasses, with modification of some technical details (such

as timing application, and proposed requirements for ensuring the

efficacy of specific treatments), but add an exemption option for

plants that can demonstrate near-term compliance with process

control and/or pathogen reduction performance standards.

Do not require establishments to apply an antimicrobial

treatment to meat and poultry carcasses, but rely instead on

appropriate identified performance standards and microbial testing

for generic E. coli, Salmonella or other pathogens as an incentive

to maintain good sanitation and hygienic slaughter practices and to

adopt

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technologies appropriate for achieving standards in particular plants.

Issue Paper 8: Specific Product Considerations Involving International

Trade

I. Objective of Proposal

The objective of the Pathogen Reduction/HACCP proposed rule is to

take a comprehensive approach to improving the safety of meat and

poultry products while recognizing international agreements.

II. Description of Comments

Many commenters identified individual situations involving imported

and exported products that they believe were potentially threatened or

undermined by certain requirements in the proposed rule.

Commenters involved in the export of meat and poultry products

raised objections to the proposed antimicrobial treatment requirements.

They stated that European Union (EU) countries would not accept product

treated with antimicrobial agents and that Canada would not accept

product treated with chlorine at the levels required in the proposal.

They recommended that FSIS accept Codex Alimentarius standards in lieu

of those in the proposed rule. Commenters also explained that the

proposed exemption for exported product was insufficient to address the

realities of slaughter operations which make separation of domestic and

export product impractical.

Questions were also raised about the requirements for foreign

plants exporting meat and poultry product to the U.S. Commenters

inquired if all foreign plants exporting products to the U.S. would be

required to have HACCP systems, and if so, how would FSIS ensure

compliance. Some commenters asked for clarification of ``equivalent

standards'' language. They were concerned that domestic producers would

be at an economic disadvantage if foreign competitors did not have to

implement HACCP to sell product in the U.S.

III. FSIS' Current Thinking on Issues Raised by Comments

After reviewing the comments relating to specific product

considerations, FSIS is examining how it can provide the regulatory

flexibility needed to adequately address the concerns noted above, meet

the requirements of international agreements and still achieve its food

safety and public health objectives.

Export Issues

The EU member states and Canada are the only countries, to our

knowledge, which restrict the use of antimicrobials on meat and poultry

carcasses

Plants producing meat and poultry for export to the EU or Canada

can choose to treat carcasses with hot water, which is currently

recognized by FSIS, the EU and Canada as an acceptable antimicrobial

treatment when applied at 165 deg.F for at least 10 seconds. Use of

this particular treatment would also preclude the need to segregate

product.

FSIS is also considering alternative approaches for achieving the

same objective sought from antimicrobial treatments. Please refer to

the previously distributed paper entitled ``Antimicrobial Treatments in

Slaughter Plants.'' These alternatives, such as microbial performance

standards, were discussed during earlier sessions of the public

meetings. However, FSIS recognizes that during consideration of these

approaches, the issues related to trade must be addressed.

Import Issues

As a signatory to the NAFTA and GATT agreements, the United States

has agreed to permit the importation of meat and poultry products from

countries which operate inspection systems judged to be equivalent to

that of the United States.

The FSIS current thinking is that countries importing meat and

poultry product to the United States would need to: 1) adopt

performance standards which achieve levels equivalent to those of the

United States, (e.g., microbial targets, chemical tolerances, economic

adulterant limits (e.g., excess moisture), aesthetic defect limits

(e.g., organ remnants), and 2) insure that process control systems

equivalent to HACCP are utilized in the plants in order to meet U.S.

performance standards and other regulatory requirements.

FSIS is currently engaged in the process of developing criteria

which it will use to determine if foreign plants engaged in export to

the United States are utilizing process control systems equivalent to

HACCP. FSIS recognizes that societal, cultural, economic and other

conditions are not exactly the same in foreign countries as those in

the United States and that effective process control systems may vary

from country to country.

Officials from some countries have proposed that their plant's

current systems of process control which rely heavily on government

intervention, control, and oversight are the most cost-effective way

for their society and will result in product in full compliance with

U.S. standards. Officials from other countries indicate they plan to

require plants to use process control systems virtually identical to

those being proposed by FSIS. As FSIS moves to establish appropriate

criteria for judging equivalency, it will consider the various aspects

of these alternative methods of assuring process control as compared to

HACCP.

In summary, the current FSIS thinking revolves around (1)

establishment of objective, science-based performance standards and (2)

evidence that systems of control equivalent to those used in the United

States are in place to insure compliance with the standards. Again,

FSIS recognizes that during the consideration of these approaches, the

issues related to trade must be addressed.

Done at Washington, DC, on October 18, 1995.

Michael R. Taylor,

Acting Under Secretary for Food Safety.

[FR Doc. 95-26296 Filed 10-23-95; 8:45 am]

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