Elimination of Requirements for Partial Quality Control Programs

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 317, 318, 319, and 381

[Docket No. 97-001P]

RIN 0583-AC35

Elimination of Requirements for Partial Quality Control Programs

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to

amend the meat and poultry products inspection regulations by removing

the requirements pertaining to partial quality control (PQC) programs

except with respect to the irradiation of poultry products. A PQC

program controls a single product, operation, or part of an operation

in a meat or poultry establishment. The proposal would remove the

design requirements for PQC programs and the requirements for

establishments to have PQC programs for certain products or processes,

other than those that apply to irradiation of poultry products. For

example, the proposal would remove the requirements for poultry

slaughtering establishments operating under the New Line Speed (NELS)

inspection system and the New Turkey Inspection System (NTIS) to have

PQC programs and the requirements concerning the design, content, and

Agency approval of those programs. The proposal would also remove from

the thermal processing regulations the requirements for FSIS prior

approval of systems and devices not specified in the regulations and

all requirements concerning PQC programs. The proposal would expand the

alternatives available to establishments under the thermal processing

regulations for ensuring the safety of their products. This proposal is

intended to provide inspected establishments with flexibility, to make

the regulations more consistent with the Pathogen Reduction (PR)/Hazard

Analysis and Critical Control Points (HACCP) regulations, and to

encourage establishments to adopt new technologies and methods that

will improve food safety and other consumer protections.

DATES: Comments must be received on or before July 19, 1999.

ADDRESSES: Submit one original and two copies of written comments to

FSIS Docket Clerk, DOCKET #97-001P, U.S. Department of Agriculture,

Food Safety and Inspection Service, Room 112 Cotton Annex Building, 300

12th Street, SW., Washington, DC 20250-3700. All comments submitted in

response to this proposed rule will be available for public inspection

in the Docket Clerk's Office between 8:30 a.m. and 4 p.m., Monday

through Friday. Those who wish to make oral comments can schedule an

appointment with the person whose name appears in FOR FURTHER

INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT: Patricia F. Stolfa, Assistant Deputy

Administrator, Office of Policy, Program Development, and Evaluation,

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

Washington, DC 20250-3700; (202) 205-0699.

SUPPLEMENTARY INFORMATION:

Background

FSIS carries out programs designed to ensure that meat, poultry,

and egg products are wholesome, not adulterated, and properly marked,

labeled, and packaged. FSIS is implementing the ``Pathogen Reduction;

Hazard Analysis and Critical Control Point (HACCP) Systems'' final rule

published July 25, 1996 (61 FR 38806), to reduce the risk of foodborne

illness associated with the consumption of meat and poultry products to

the maximum extent possible. The Pathogen Reduction (PR)/HACCP final

rule requires establishments to take appropriate and feasible measures

to prevent or reduce the likelihood of physical, chemical, and

microbiological hazards in the production of meat and poultry products.

FSIS is reviewing its other regulations to determine how they can

be made more consistent with the PR/HACCP regulations and the

regulatory approach they embody. This approach favors performance-based

standards over prescriptive, command-and-control regulations. Command-

and-control requirements specify, often in great detail, how a plant is

to achieve particular food safety or other regulatory objectives, while

performance standards state the objectives or levels of performance to

be achieved and give a plant the ability to describe how it will

achieve them. Included in the Agency's review are regulations on

sanitation, meat and poultry products with visible defects affecting

safety or quality, and economic adulteration of meat and poultry

products.

FSIS announced its regulatory review in a December 29, 1995,

advance notice of proposed rulemaking (ANPR) ``FSIS Agenda for Change''

(60 FR 67469). The Agency said that, by eliminating unnecessary

regulations and replacing command-and-control prescriptions with

performance standards, inspected establishments would have greater

flexibility to adopt innovations that can yield food-safety benefits.

Among the regulations FSIS has identified as candidates for

modification or elimination are those that delimit processing and

treatment methods intended to eliminate specific food safety hazards

and requirements concerning quality control programs.

FSIS has already reduced its role of approving and specifying in

detail the design and operation of establishment-operated partial

quality control (PQC) programs. In 1997, the Agency published a final

rule that, among other things, removes the requirement for FSIS prior

approval of most PQC programs (62 FR 45016, August 25, 1997).

Recognizing that the establishment bears primary responsibility for the

control of its own manufacturing processes, FSIS now thinks it

appropriate to take the further step of eliminating PQC requirements

other than for irradiation of poultry (9 CFR 381.149(b)), so that

establishments will have the flexibility they need to be innovative,

and consistent with HACCP and the Agency's regulatory policy. (FSIS

proposed to remove requirements for quality control programs for

poultry-product irradiation in its February 24, 1999, proposal on the

irradiation of meat and meat products (64 FR 9809).)

Quality Control

Quality control, in general, is a planned, documented system of

activities intended to ensure the

[[Page 26893]]

stability of processes and uniformity of products. Quality control

programs and systems are based on the assumption that there is normal

variation in any process, and that the process is under control if that

variation is not exceeded.

In the food industry, quality control systems are used in

processing operations to make sure that products from TV dinners to

hotdogs will be exactly the same--will have the same content, flavor,

color, texture, etc.--no matter how many thousands are made in a

production run. Quality control programs can be used to maintain normal

process variation within the limits prescribed in a standard, such as

the 50-percent-fat limitation in a breakfast sausage. If the expected

variation is exceeded, corrective action is taken to restore process

stability.

Under FSIS regulations, a company may choose to place all of the

processes and products in a plant under a comprehensive, or total,

quality control system, or the company may choose to place only

individual products or processes under quality control. A quality

control program for only one process or product in a plant is known as

a partial quality control (PQC) program.

Some PQC programs control product potential health and safety

problems; others focus on economic or quality factors. PQC programs

controlling for safety factors include those for thermally processed

products, which are intended primarily to prevent toxin formation in

the processed product. The programs for cooked beef products are

intended to ensure that the processing of the products meets the

regulatory requirements for handling, processing (time, temperature,

and relative humidity), and storage to prevent pathogen formation in

the products. PQC programs that control for product safety have been

largely superseded by required HACCP plans.

PQC programs that control for economic or non-food-safety factors

include those used to control the fat and water content of hotdogs, the

number of meatballs in, or pepperoni slices on, a product, and the

moisture or protein-fat-free (PFF) content of a product labeled ``ham,

water added.'' The quality control program for mechanically separated

(species) (MS(S)) is intended to control bone particle size, calcium

content, fat and protein content, and protein efficiency ratio (9 CFR

319.5). The programs for pressed ham and spiced ham products are

intended to ensure that the products meet the PFF regulatory

requirements of Sec. 319.104.

PQC programs to control products for economic factors are intended

to prevent the marketing of products that are misbranded or that lack

the quality or value that consumers expect. A plant operating under a

PQC program for net weight keeps records of its checks and corrective

actions to avoid lot inspection. Under PQC programs for fat and water

in frankfurters, plants keep ingredient records by lot and results of

laboratory tests for verification by FSIS inspectors. A plant operating

a PQC program for boneless meat inspection does its own on-line

inspection and keeps records. The FSIS inspector randomly selects

samples of product that the plant has already inspected to ensure that

the records are accurate.

Establishments are required by current regulations to have PQC

programs for certain products or processes, such as the one for MS(S),

just mentioned. A PQC program for on-line carcass quality control is

required for an establishment operating under either the NELS or the

NTIS poultry inspection system (9 CFR 381.76(c)).

PQC Programs in Slaughtering Plants

The Agency conducts verification checks on the plant-operated PQC

programs required for certain inspection systems. Establishments being

considered for implementation of the NELS and NTIS inspection systems

(currently, about 10 per year) must meet requirements both for

facilities and for PQC programs.

Interested establishments are required to obtain FSIS approval of

their PQC programs before the programs can be implemented on a trial

basis. Unacceptable PQC programs are returned to the establishment for

correction.

Once approved, PQC programs are subject to on-site review by the

Agency for six months after implementation. The establishment then

submits an updated PQC program to the Agency for final review. If, at

that stage, the program is found to be acceptable, full approval is

granted, although the establishment remains subject to Agency

verification checks. If the program is unacceptable, the trial period

may be extended or approval of the program may be withdrawn.

The Agency provides guidelines to help interested establishments

prepare for implementation of the NELS and NTIS inspection systems.

Instructions for developing PQC programs are included in those

guidelines. The Agency also offers instruction on slaughter quality

control programs to Government and industry personnel at the FSIS

Training Center.

Proposed Changes

FSIS is proposing to eliminate the requirement in 9 CFR 317.21(b)

that establishments have, as an alternative to State or local

certification of scales, PQC programs or total quality control system

provisions for checking the accuracy of scales. The Agency is proposing

simply to require that there be a certification of accuracy from State

or local authorities or from a State-registered or -licensed scale

repair firm or person. Establishments could continue to maintain scale-

checking provisions in their QC programs and systems.

The Agency is proposing to remove from the meat and poultry

inspection regulations the design requirements for partial quality

control programs (9 CFR 318.4(d), 381.145(d)). The provisions outline

what is necessary when an establishment is required to have a PQC

program. Because the Agency is proposing to revoke the regulatory

requirements pertaining to PQC programs, there is no need to describe

what is necessary when PQC is required.

FSIS would also remove quality control requirements (9 CFR 318.7)

governing the use of nitrites in bacon curing and the use of certain

organic acids singly or in combination to delay the discoloration of

fresh meat cuts. Such requirements are incompatible with the Agency's

regulatory objectives because they specify a manner of compliance

rather than simply a performance standard.

Both the nitrite and the organic acid regulations clearly state the

maximum limits of use of the substances they concern. The consumer is

also informed by product labeling of the presence of the substances in

the products. The regulations provide clear limits and adequate

consumer protections without the quality control requirements. The

Agency is also proposing to improve the accuracy of the regulation by

using the term ``production of botulinum toxin'' rather than ``growth

of botulinum toxin'' (see 9 CFR 318.7(b)(3)(ii)). FSIS is aware that

these food-safety regulations also may be regarded as inconsistent with

the PR/HACCP regulations, but the Agency would prefer to address this

inconsistency in a future rulemaking.

The Agency proposes to make the meat and poultry canning

regulations (9 CFR 318.305 and 381.305) more consistent with the

Agency's new, non-command-and-control regulatory approach by

eliminating a number of prior-approval requirements. First, the

requirement that the Agency prior-approve temperature-indicating

devices other than mercury-in-glass

[[Page 26894]]

thermometers (at Secs. 318.305(a)(1)(ii) and 381.305(a)(1)(ii)) would

be replaced. Temperature-indicating devices, such as resistance

temperature detectors, could be used and, as is the case currently,

they would have to meet known standards of accuracy for such devices,

but the frequency of testing for accuracy would not be prescribed.

The Agency is also proposing to remove the requirement for case-by-

case evaluation and approval by FSIS of thermal processing systems not

specified in the regulations. As amended, 9 CFR 318.305(f) and

381.305(f) would require that such systems be adequate to produce

shelf-stable products consistently and uniformly. These requirements

reflect the basic purposes of the canning regulations.

FSIS is also proposing to remove from the thermal processing

regulations (9 CFR 318.307(b) and 381.307(b)) provisions concerning PQC

programs and requirements for FSIS prior approval of thermal processing

systems not specified in the regulations, including monitoring and

recording devices not specified in the regulations. The Agency

tentatively concludes that these regulations will ensure the adequacy

of these systems without the requirement that the Agency is proposing

to delete, which is inconsistent with the PR/HACCP regulations.

The Agency is also proposing to remove from the thermal processing

regulations the requirements (in Secs. 318.308 and 309 and

Secs. 381.308 and 309) concerning partial quality control programs to

control process deviations and establishment finished product

inspection procedures. The Agency tentatively finds that these

requirements are unnecessary. The detailed prescriptions in these

sections, which are based on HACCP principles, would remain as

acceptable protections against potential microbial contamination.

Under this proposal, a thermal processing establishment would have

four alternatives available to control process deviations identified

in-process. The establishment could:

(1) Provide for how it will handle the deviations under a HACCP

plan; or, until subject to 9 CFR part 417, (2) follow the existing

regulations (Secs. 318.308(d) and 381.308(d)); (3) handle the

deviations under an approved total quality control system until the PR/

HACCP rule becomes applicable to it; or (4) use alternative documented

procedures for handling process deviations. The alternative documented

procedures could be provisions of a HACCP plan, such as corrective

actions to be taken, recordkeeping, or monitoring procedures, that

would be followed when process deviations occurred. They could also

include partial quality control programs, developed by or for the

establishment, but not subject to FSIS approval. Such food-safety-

related PQC programs would, however, be superseded by or integrated

with provisions of the establishment's HACCP plan when that plan is

implemented.

Similarly, under this proposal, a thermal processing establishment

would have four alternatives for handling finished product inspections.

The finished product inspections could be handled under: (1) The

existing regulations (Secs. 318.309(d) and 381.309(d)); (2) a HACCP

plan; (3) the provisions of an approved total quality control system,

until the PR/HACCP final rule is applicable to the establishment; or

(4) alternative documented procedures for handling finished product

inspections. The alternative documented procedures could be PQC

programs or the HACCP plan provisions.

In any case, any alternative procedures for handling process

deviations or finished product inspections would have to ensure that

only safe, stable product is shipped in commerce. This proposed

requirement dictates that not only would the procedures have to ensure

that the product is free of microorganisms of public health

significance, but also that it is not adulterated by other types of

microorganisms, such as ``flat-sour'' bacteria or other spoilage

organisms. This proposed requirement is consistent with the aims of

HACCP and with the statutory prohibitions against the distribution of

adulterated and misbranded meat and poultry products in commerce.

The proposed amendments would make the thermal processing

regulations more consistent with the PR/HACCP final rule by explicitly

providing a HACCP-plan alternative to the prescriptive procedures

(consistent with Sec. 417.2(b)(3)) and by including, as an option for

handling process deviations or final product inspections, alternative

documented procedures that ensure that only safe and stable products

are shipped in commerce. This option would provide the establishment

with the flexibility to use PQC programs or other procedures that meet

a regulatory public health standard.

It should be noted that, under the HACCP regulations, an

establishment's HACCP plan does not have to address potential microbial

hazards in thermally processed/commercially sterile product if the

establishment is following the current regulatory requirements for such

product. However, the HACCP plan must address physical and chemical

hazards to which the product may be subject.

Besides proposing to remove the requirements pertaining to PQC

programs that control food-safety factors, which are inconsistent with

PR/HACCP, FSIS is proposing to remove the requirements affecting

economic or quality-related PQC programs. FSIS considers these

requirements to be too prescriptive. They tend to perpetuate the

command-and-control approach to food inspection and regulation. They

are not in keeping with the Agency's new regulatory approach, which is

oriented more toward monitoring industry compliance with performance-

related objectives.

First, the Agency is proposing to remove the QC system requirements

from the regulations and requirements governing the identity and

composition of MS(S) product and label approval of the product (9 CFR

319.5). The MS(S) regulations specify the maximum calcium content, the

minimum protein content, the protein efficiency ratio, the maximum fat

content, and the maximum bone particle size for the product. The

regulations also specify the elements that the QC system must contain,

including a written description of the methods used by the

establishment to maintain uniformity of raw materials used in

manufacturing product and to control handling and processing of the raw

materials and finished product. The regulations also specify the sample

size and sampling frequency for food-chemistry analysis of product to

determine compliance with the standards. FSIS regards these provisions

as overly prescriptive and believes that, to achieve the purposes of

the MS(S) regulations, it is sufficient to set the product standards

for fat, protein, calcium content, and bone particle size.

The Agency is also proposing to update the provision for finished

product samples to be analyzed according to methods of the Association

of Official Analytical Chemists (AOAC) or methods listed in the FSIS

``Chemistry Laboratory Guidebook'' to reflect use of the most recent

edition of the AOAC compendium. In addition, FSIS is proposing to give

establishments the latitude to use validated scientific methods

equivalent to, but not listed in, the AOAC and FSIS references. Under

this proposed action, the establishments will have flexibility to

choose the most appropriate means of ensuring that

[[Page 26895]]

MS(S) meets the compositional and labeling identity requirements of the

regulations, but they will also have the burden of demonstrating

equivalence.

The Agency is aware, however, that some may disagree with the

evaluation of the MS(S) QC and analytical requirements as overly

prescriptive; their comments on this matter are invited. Others may

regard the incorporation by reference of the AOAC methods as

unnecessary and such standards as those for fat content and protein

efficiency ratio as duplicative of other regulatory requirements. Their

comments are invited as well.

Second, consistent with the other changes proposed in this

document, FSIS is proposing to eliminate the quality control program

requirements from the protein-fat-free (PFF) percentage regulations

(Secs. 319.104 and 319.105) for various ``finely divided'' cured ham

products, such as patties, chopped or pressed ham, and spiced ham.

Establishments would still be required to abide by the PFF percentage

limits for these products.

Finally, FSIS is proposing to remove the requirement that poultry

slaughtering establishments operating under the NELS and NTIS

inspection systems have PQC programs for carcass defects. If this

proposed change is adopted, the establishments will have the

flexibility to adopt quality control programs or other measures for

ensuring the quality of their products. Removing the prior-approval

aspect of these requirements will contribute to clarifying the

respective roles of the inspection service and the regulated industry--

a necessary task in making the requirements consistent with HACCP.

FSIS inspectors would continue to check poultry in NELS and NTIS

plants for visible contamination and carcass trimming defects.

Executive Order 12866 and Regulatory Flexibility Act

This proposed rule has been determined to be significant, though

not economically significant, and was reviewed by the Office of

Management and Budget under Executive Order 12866.

FSIS is proposing to eliminate the regulatory requirements

pertaining to establishment-operated PQC programs. This action would

remove regulatory obstacles to innovation and command-and-control

requirements inconsistent with the Agency's new regulatory approach and

the objectives of the PR/HACCP regulations. In its August 25, 1997,

final rule (62 FR 45016), the requirements for FSIS prior approval of

most PQC programs were eliminated. This action was taken to facilitate

the transition to HACCP in official establishments producing the

greatest portion of meat and poultry products consumed in the United

States. FSIS is proposing to take the additional step of eliminating

most requirements for establishments to have PQC programs for specific

products or processes, as well as design requirements affecting most

PQC programs. The only PQC program requirements this proposal would

leave in place would be the requirement for QC programs for irradiated

chicken. However, as mentioned previously, this requirement is being

addressed in another rulemaking proceeding (64 FR 9809).

The alternatives to this proposed rulemaking that FSIS considered

were, in addition to the alternative of no rulemaking, those of

mandating additional in-plant controls and of mandating general

requirements and standards for PQC programs.

The alternative of no rulemaking would impose no additional

regulatory burdens on establishments, which would continue to have the

assurance that their PQC programs meet basic design criteria. However,

the Agency rejected this alternative because not changing the

regulations would leave in place a prescriptive regulatory regime for

process controls and PQC programs that conflict in a material way with

the objectives of the PR/HACCP final rule. Under HACCP, establishments

assume responsibility for building science-based, preventive process

controls into the food production system to reduce or eliminate food

safety hazards. This includes taking responsibility for ensuring that

processes conform with sound food safety performance standards.

Establishments need to be able to implement better and more innovative

food-safety and other consumer-protection strategies. This includes the

flexibility to design a PQC program and determine its content and

implementation date.

The alternative of mandating additional in-plant controls, whether

in addition to or in lieu of PQC requirements, would add regulatory

assurances that processes are under control and that products are safe,

wholesome, and not misbranded. However, this alternative would add

prescriptive, command-and-control requirements and restrict the scope

for establishment food-safety initiatives, contradicting the Agency's

new regulatory approach. The additional requirements also would

probably not result in food-safety improvement.

The alternative of mandating new general requirements or standards

for PQC programs would differ little in its effects from the current

requirements for PQC programs to have certain features and for process

control under the programs to be based on generally accepted

statistical principles (9 CFR 318.4(d); 381.145(d)). Even if the

current requirements were condensed, they would still be inconsistent

with the PR/HACCP regulations and with the Agency's new regulatory

approach, establishments would continue to incur a substantial

recordkeeping burden, and the Agency would have nearly the same burden

as it now does of verifying establishment compliance with the

requirements.

FSIS chose the option of eliminating regulatory requirements for

all PQC programs except QC programs for the irradiation of poultry

products. This option provides establishments with the most flexibility

in implementing process control programs in a HACCP environment. FSIS's

proposed rule on irradiation of meat and meat products (64 FR 9089,

February 24, 1999) would eliminate the requirement for QC programs in

facilities where poultry products are irradiated.

Implementation of this proposed rule would enable FSIS to redirect

resources from PQC program verification to other activities for

ensuring that products are not adulterated or misbranded. FSIS has

considered a number of alternatives to PQC program verification, such

as finished product sampling for microbiological or food chemistry

analysis and market sampling. Market sampling or national surveys can

be used in lieu of inspecting lots or evaluating PQC programs for fat

and water content of frankfurters. An alternative to FSIS evaluation of

PQC programs for basting solutions in poultry products is finished

product sampling for chemical analysis.

In-plant sampling of finished products for chemical analysis is a

tool that FSIS has used--and will continue to use--to determine whether

products are in compliance with regulatory requirements and to verify

the effectiveness of in-plant controls. To be most effective, such

sampling and analysis would be carried out in conjunction with Agency

HACCP-verification and other verification activities.

FSIS also regards market sampling as a potentially useful tool for

enforcing the statutes prohibiting the distribution in commerce of

adulterated and misbranded meat and poultry products and for checking

the effectiveness of establishment process controls.

[[Page 26896]]

Marketplace sampling and testing can also help in addressing food

safety hazards arising in post-processing distribution of meat and

poultry products.

This proposal would affect, overall, as many as 72 poultry

slaughtering establishments and about 3,550 establishments that process

meat and poultry products beyond slaughtering, dressing, and cut-up.

The most far-reaching effect of the rule would be to increase the

flexibility establishments have in controlling their processes. This

benefit would arise from eliminating the required PQC program elements

in Secs. 318.4(d) and 381.145(d).

With or without this proposal, establishment HACCP plans will

supersede or incorporate the few PQC programs that control food-safety

factors. Under the proposal, most establishments that have PQC programs

that control for non-food safety factors would continue to use the

programs. In all likelihood, in developing new PQC programs, they would

continue to include the information now required by FSIS. They would

also be free to adopt other methods of process control and different

techniques of observation, measurement, documentation, recordkeeping,

and evaluation than are prescribed in the current regulations. They

could change their PQC-controlled operations to integrate their food

quality process control more effectively with their HACCP system

operations to improve overall efficiency. For example, raw material

control, now a required element in PQC programs, could be handled under

an establishment?s HACCP plan, as could process controls for food

safety. Similarly, the records requirements for PQC programs could be

superseded by more efficient and appropriate establishment-developed

systems. Establishments would thus be able to achieve unquantifiable

gains in efficiency that would yield food-safety and other consumer-

protection benefits.

FSIS-inspected establishments develop about 1,900 PQC programs a

year according to regulatory design specifications. Assuming that a PQC

program is developed by a QC manager earning about $26 an hour, and

that it takes about 20 hours, on average, to develop a PQC program, the

cost to an establishment of developing such a program is about $520.

FSIS estimates that the cost to the regulated industry of developing

such programs is about $1,000,000 per year.

This cost of developing PQC programs according to FSIS

requirements, plus $13 million in annual operating costs for about

1,852 mandatory (required by regulation) PQC programs ($26/hr. X 260

hrs./yr./program X 1,852 programs), add up to about $14 million in

costs to the regulated industry.

For most establishments, the proposal would not yield immediate,

direct savings from removal of burdens associated with developing PQC

programs because most PQC programs are voluntarily adopted by

establishments. Establishments likely would continue the use of QC

methods in their operations, so the removal of the regulatory

requirement for establishments to follow the regulatory design

specifications would not immediately yield a savings to establishments.

Further, a substantial proportion of the costs of complying with this

regulation was removed with the publication of the final rule

eliminating prior approvals for facilities, equipment, and PQC programs

(62 FR 45016; August 25, 1997).

However, FSIS currently requires that if establishments adopt PQC

programs, the programs must meet certain design specifications and must

contain certain specified information. Some establishments that are

required to have PQC programs for certain products and processes would

benefit from the removal of burdens associated with developing PQC

programs. These establishments, including those involved in producing

MS(S), meat cuts treated with organic acids, and other processing,

could benefit from shifting some portion of their PQC program

development and operation costs into HACCP-related or other activities.

Also, under the proposed regulatory amendments, establishments

would have greater freedom to innovate. An indeterminate proportion of

the annual burden of developing PQC programs according to FSIS

specifications could eventually be channeled into more efficient and

effective use of industry resources, especially where PQC programs have

been operated.

Thus, although there would not be a direct savings from the removal

of the regulatory requirements governing PQC programs, the industry

potentially would be able to make more efficient and effective use of

the $1 million or so in annual costs of developing the programs.

Finally, the proposed rule would permit FSIS to reallocate field

inspection and headquarters resources now used in oversight of

establishment-operated PQC programs to higher priority food safety-

related activities.

Regulatory Flexibility Act

The Administrator of FSIS has determined that this proposed rule

will not have a significant effect on a substantial number of small

entities. The proposal would affect about 72 poultry slaughtering

establishments, most of which are large business enterprises. It also

would affect as many as 3,550 official meat and poultry processing

establishments, of which a substantial majority, 3,330, are considered

small entities under Small Business Administration criteria (500 or

fewer employees per establishment). However, the proposal would not

have a significant effect on these establishments. It would impose no

new regulatory requirements necessitating investments or other resource

commitments by establishments but would, by removing a number of

existing regulatory requirements, permit more efficient resource

utilization, especially to support establishment HACCP systems.

The proposal would remove most remaining requirements for

establishments to have PQC programs for certain products or processes

and the general requirement concerning the design of such programs. The

proposal would give inspected establishments greater flexibility to

innovate and to introduce new processes or products that meet HACCP or

other consumer protection objectives. As a result, the proposal would

theoretically provide several thousand dollars of regulatory relief

annually per establishment.

The proposal would enable establishments to avoid the costs

associated with developing and implementing PQC programs that address

regulatory requirements for the use of certain substances in

preparation of meat and poultry products, such as the use of organic

acids to delay discoloration of fresh meat cuts. Thermal processing

establishments (of which there are about 130) would avoid the costs

associated with developing PQC programs according to Agency

specifications and the costs associated with obtaining Agency prior

approvals.

As many as 3,330 small establishments would no longer be required

to operate PQC programs for certain processes (such as PQC programs for

processing cooked beef) and products (such as mechanically separated,

or ``deboned,'' product). Small and large establishments would

theoretically save about $520 per PQC program in development costs for

320 mandatory PQC programs, or $161,720 total. Out of this total, small

establishments would save about $151,320. Small establishments could

thus be expected to save about $4,000 each in annual recurring costs

associated with developing mandatory PQC programs.

[[Page 26897]]

Operating costs of PQC programs vary widely. A simple PQC program

to verify the accuracy of scales, for example, may require that tests

be performed only several times a year, at little cost in operator

time. A PQC program for a complex process, on the other hand, may

require daily tests and data collection and recordkeeping tasks lasting

up to 4 hours. For the purposes of this document, PQC programs are each

assumed to require up to 1 hour's worth of daily attention by the

establishment QC specialist. The removal of the PQC requirements would,

at least theoretically, relieve small establishments of these burdens.

Assuming, for example, that small establishments incur annual costs

of about $12,000,000 in operating mandatory PQC programs (solely in

operating the QC evaluation process of such programs, and not including

laboratory analysis, and other special facilities that may be required

to determine whether products are in compliance with the regulations),

each establishment could theoretically save about $4,000 in PQC program

operations.

In addition, small establishments would benefit through

unquantifiable savings accruing from removal of regulatory design

requirements for both mandatory and voluntary PQC programs. They would

have additional flexibility, beyond the removal of prior approval

requirements effected by FSIS Docket No. 95-032F, to develop and

implement HACCP-consistent or other process control systems.

Thus, about $8,000 in recurring savings could theoretically accrue

to each small meat and poultry establishment. However, because many, if

not most, affected establishments would be likely to continue to

operate PQC programs that help in producing products with consistent

and uniform characteristics, establishments may not choose to reap the

theoretical savings that could result from eliminating their PQC

programs. The effect of the proposed rule on the substantial number of

affected small establishments would thus not likely be substantial.

Paperwork Requirements

Title: Processing Procedures and Quality Control Systems.

Type of Collection: Revision.

Abstract: FSIS has reviewed the paperwork and recordkeeping

requirements in this proposed rule in accordance with the Paperwork

Reduction Act. This proposed rule would substantially reduce reporting

requirements for official establishments. The proposed rule would

remove the design requirements affecting most PQC programs that

establishments have and most requirements for establishments to have

PQC programs for certain products or processes. Currently, there are

624,465 burden hours associated with the PQC program requirements. FSIS

will request OMB to eliminate all these burden hours from the

information collection request 0083-0089.

List of Subjects

9 CFR Part 317

Meat inspection, Reporting and recordkeeping requirements.

9 CFR Part 318

Meat inspection, Reporting and recordkeeping requirements.

9 CFR Part 319

Food labeling, Meat inspection.

9 CFR Part 381

Poultry and poultry products, Reporting and recordkeeping

requirements.

For the reasons set forth in the preamble, FSIS is proposing to

amend 9 CFR Chapter III, the Federal meat and poultry inspection

regulations, as follows:

PART 317--LABELING, MARKING DEVICES, AND CONTAINERS

1. The authority citation for part 317 would continue to read as

follows:

Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

Sec. 317.21 [Amended]

2. Paragraph (b) of Sec. 317.21 would be amended by removing the

comma and all words following the word ``person''.

PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND

PREPARATION OF PRODUCTS

3. The authority citation for part 318 would continue to read as

follows:

Authority: 7 U.S.C. 138f, 450, 1901-1906; 21 U.S.C. 601-695; 7

CFR 2.18, 2.53.

Sec. 318.4 [Amended]

4. Paragraph (d) of Sec. 318.4 would be removed.

5. Section 318.7 would be amended to read as follows:

a. Paragraphs (b)(3)(i) and (b)(3)(ii) would be revised;

b. The table in paragraph (c)(4), under the Class of substance

``Miscellaneous,'' the entry for the Substance ``Ascorbic acid,

erythorbic acid, citric acid, sodium acetate, and sodium citrate,

singly or in combination'' would be revised.

The revisions would read as follows:

Sec. 318.7 Approval of substances for use in the preparation of

products.

* * * * *

(b) * * *

(3) * * *

(i) 100 ppm ingoing (potassium nitrite at 123 ppm ingoing); and 550

ppm sodium ascorbate or sodium erythorbate (isoascorbate) shall be

used; or

(ii) A predetermined level between 40 and 80 ppm (potassium nitrite

at a level between 49 and 99 ppm); 550 ppm sodium ascorbate or sodium

erythorbate (isoascorbate); and additional sucrose or other similar

fermentable carbohydrate at a minimum of 0.7 percent and an inoculum of

lactic acid producing bacteria such as Pediococcus acetolactii or other

bacteria demonstrated to be equally effective in preventing the

production of botulinum toxin at a level sufficient for the purpose of

preventing the production of botulinum toxin.

* * * * *

(c) * * *

(4) * * *

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

Class of substance Substance Purpose Product Amount

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

* * * * * * *

Miscellaneous..................... Ascorbic acid, erythorbic To delay Fresh beef cuts, Not to exceed, singly or in combination, 500

acid, citric acid, discoloration. fresh lamb cuts, ppm or 1.8 mg/sq inch of product surface of

sodium ascorbate and and fresh pork cuts. ascorbic acid (in accordance with 21 CFR

sodium citrate, singly 182.3013), erythorbic acid (in accordance

or in combination. with 21 CFR 182.3041), or sodium ascorbate

(in accordance with 21 CFR 182.3731); and/or

not to exceed, singly or in combination, 250

ppm or 0.9 mg/sq inch of product surface of

citric acid (in accordance with 21 CFR

182.6033), or sodium citrate (in accordance

with 21 CFR 182.6751).

[[Page 26898]]

* * * * * * *

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

* * * * *

6. Paragraphs (a)(1)(ii) and paragraph (f) of Sec. 318.305 would be

revised to read as follows:

Sec. 318.305 Equipment and procedures for heat processing systems.

(a) * * *

(1) * * *

(i) * * *

(ii) Other devices. Temperature-indicating devices used in lieu of

mercury-in-glass thermometers, such as resistance temperature

detectors, shall meet known, accurate standards for such devices when

tested for accuracy. The records of such testing shall be available to

FSIS program employees.

* * * * *

(f) Other systems. All other systems not specifically delineated in

this section and used for the thermal processing of canned product

shall be adequate to produce shelf-stable products consistently and

uniformly.

* * * * *

7. Paragraph (b) of Sec. 318.307 would be revised to read as

follows:

Sec. 318.307 Record review and maintenance.

* * * * *

(b) Automated process monitoring and recordkeeping. Automated

process monitoring and recordkeeping systems shall be designed and

operated in a manner which will ensure compliance with the applicable

requirements of Sec. 318.306.

* * * * *

8. In Sec. 318.308, paragraph (b) would be revised, paragraph (c)

would be removed and reserved, and paragraph (d) introductory text

would be revised to read as follows:

Sec. 318.308 Deviations in processing.

* * * * *

(b) Deviations in processing (or process deviations) shall be

handled:

(1) Under a HACCP plan for thermally processed/commercially sterile

product that addresses hazards associated with microbial contamination;

or

(i) Under the provisions of paragraph (d) of this section; or

(2) Until the establishment is subject to part 417 of this chapter,

(i) Under an FSIS-approved total quality control system; or

(ii) Under alternative documented procedures for handling process

deviations that will ensure that only product that is safe and stable

is shipped in commerce.

(c) [Reserved]

(d) Procedures for handling process deviations where the HACCP plan

for thermally processed/commercially sterile product does not address

food safety hazards associated with microbial contamination, where

there is no approved total quality control system, or where the

establishment has no alternative documented procedures for handling

process deviations.

* * * * *

9. In Sec. 318.309, paragraph (a) would be revised, paragraphs (b)

and (c) would be removed and reserved, and paragraph (d) introductory

text would be revised, to read as follows:

Sec. 318.309 Finished product inspection.

(a) Finished product inspections shall be handled:

(1) Under the provisions of paragraph (d) of this section;

(2) Under a HACCP plan for thermally processed/commercially sterile

products that addresses hazards associated with microbiological

contamination;

(3) Under an FSIS-approved total quality control system; or

(4) Under alternative documented procedures that will ensure that

only safe and stable product is shipped in commerce.

(b) [Reserved]

(c) [Reserved]

(d) Procedures for handling finished product inspections where the

HACCP plan for thermally processed/commercially sterile product does

not address food safety hazards associated with microbial

contamination, where there is no approved total quality control system,

or where the establishment has no alternative documented procedures for

handling finished product inspections.

* * * * *

PART 319--DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION

10. The authority citation for part 319 continues to read as

follows:

Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR

2.18, 2.53.

11. Paragraph (e)(2) of Sec. 319.5 would be revised to read as

follows:

Sec. 319.5 Mechanically Separated (Species).

* * * * *

(e) * * *

(2) Analytical methods used by establishments in verifying the fat,

protein, and calcium content of product consisting of or containing

Mechanically Separated (Species) shall be among those listed in

``Official Methods of Analysis of the Association of Official

Analytical Chemists (AOAC),'' 16th edition, 1995, Secs. 960.39, 976.21,

928.08 (Chapter 39), and 940.33 (Chapter 45), which is incorporated by

reference, or, if no AOAC method is available, in the ``Chemistry

Laboratory Guidebook,'' U.S. Department of Agriculture, Washington, DC,

March 1986 edition, sections 6.011-6.013, Revised June 1987 (pages 6-35

through 6-65), or by appropriate methods validated by scientific bodies

in collaborative trials. The ``Official Methods of Analysis of the

Association of Official Analytical Chemists,'' 16th edition, 1995, is

incorporated by reference with the approval of the Director of the

Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51.

Sec. 319.104 [Amended]

12. Section 319.104 would be amended in paragraph (a) by removing

the last sentence of footnote 3 to the chart.

Sec. 319.105 [Amended]

13. Section 319.105 would be amended in paragraph (a) by removing

the last sentence of footnote 2 to the chart.

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

14. The authority citation for part 381 continues to read as

follows:

Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.18,

2.53.

15. Section 381.76 would be amended to read as follows:

a. Paragraph (b)(1)(ii)(b) would be revised.

b. Paragraph (b)(1)(iii)(b) would be revised.

c. Paragraph (b)(4)(i)(a), introductory text, would be revised.

d. Paragraph (b)(4)(i)(b) would be revised.

e. Paragraph (b)(4)(ii) would be removed and reserved.

[[Page 26899]]

f. Paragraph (b)(4)(iii) would be removed and reserved.

g. Paragraph (b)(5)(i)(a) introductory text, would be revised.

h. Paragraph (b)(5)(i)(b) would be revised.

i. Paragraph (b)(5)(ii) would be removed and reserved.

j. Paragraph (b)(5)(iii) would be removed and reserved.

k. Paragraph (c) would be removed.

The revisions would read as follows:

Sec. 381.76 Post-mortem inspection, when required; extent;

traditional, Streamlined Inspection System (SIS), New Line Speed (NELS)

Inspection System and the New Turkey Inspection (NTI) System; rate of

inspection.

* * * * *

(b)(1) * * *

(ii) * * *

(b) The Administrator determines that the establishment has the

intent and capability to operate at line speeds greater than 70 birds

per minute, and meets all the facility requirements in Sec. 381.36(d).

(iii) * * *

(b) The Administrator determines that the establishment meets all

the facility requirements in Sec. 381.36(e).

* * * * *

(4) * * *

(i) * * *

(a) Post-mortem inspection. The establishment shall provide three

inspection stations on each eviscerating line in compliance with the

facility requirements Sec. 381.36(d)(1). The three inspectors shall

inspect the inside, viscera, and outside of all birds presented. Each

inspector shall be flanked by two establishment employees--the

presenter and the helper. The presenter shall ensure that the bird is

properly eviscerated and presented for inspection and the viscera

uniformly trailing or leading. The inspector shall determine which

birds shall be salvaged, reprocessed, condemned, retained for

disposition by the veterinarian, or allowed to proceed down the line as

a passed bird subject to reinspection. Poultry carcasses with certain

defects not requiring condemnation of the entire carcass shall be

passed by the inspector, but shall be subject to reinspection to ensure

the physical removal of the specified defects. The helper, under the

supervision of the inspector, shall mark such carcasses for trim when

the defects are not readily observable. Trimming or birds passed

subject to reinspection shall be performed by:

* * * * *

(b) A reinspection station shall be located at the end of each

line. This station shall comply with the facility requirements in

Sec. 381.36(d)(2). The inspector shall ensure that the establishment

has performed the indicated trimming of carcasses passed subject to

reinspection by visually monitoring, checking data, and/or gathering

samples at the station or at other critical points on the line.

(ii) [Reserved]

(iii) [Reserved]

(5) * * *

(i) * * *

(a) Post-mortem inspection. Each inspection station must comply

with the facility requirements in Sec. 381.36(e)(1). Each inspector

shall be flanked by and establishment employee assigned to be the

inspector's helper. The one inspector on an NTI-1 Inspection System

shall be presented every bird. Each inspector on an NTI-2 Inspection

System line shall be presented every other bird on the line. An

establishment employee shall present each bird to the inspector

properly eviscerated with the back side toward the inspector and the

viscera uniformly trailing or leading. Each inspector shall inspect the

inside, viscera, and outside of all birds presented. The inspector

shall determine which bird shall be salvaged, reprocessed, condemned,

retained for disposition by a veterinarian, or allowed to proceed down

the line as a passed bird subject to reinspection. Turkey carcasses

with certain defects not requiring condemnation of the entire carcass

shall be passed by the inspector, but shall be subject to reinspection

to ensure the physical removal of the specified defects. The helper,

under the supervision of the inspector, shall mark such carcasses for

trim when the defects of birds passed subject to reinspection shall be

performed by:

* * * * *

(b) Reinspection. A reinspection station shall be located at the

end of the lines. This station shall comply with the facility

requirements in Sec. 381.36(e)(2). The inspector shall ensure that

establishments have performed the indicated trimming of each carcass

passed subject to reinspection by visually monitoring, checking data,

and/or sampling product at the reinspection station and, if necessary,

at other points, critical to the wholesomeness of product, on the

eviscerating line.

(ii) [Reserved]

(iii) [Reserved]

Sec. 381.121d [Amended]

16. Paragraph (b) of Sec. 381.121d would be amended by removing the

comma and all words following the word ``person.''

Sec. 381.145 [Amended]

17. Paragraphs (d) and (e) of Sec. 381.145 would be removed.

18. Paragraphs (a)(1)(ii) and (f) of Sec. 381.305 would be revised

to read as follows:

Sec. 381.305 Equipment and procedures for heat processing systems.

(a) * * *

(1) * * *

(ii) Other devices. Temperature-indicating devices used in lieu of

mercury-in-glass thermometers, such as resistance temperature

detectors, shall meet known, accurate standards for such devices when

tested for accuracy. The records of such testing shall be available to

FSIS program employees.

* * * * *

(f) Other systems. All other systems not specifically delineated in

this section and used for the thermal processing of canned product

shall be adequate to produce shelf-stable products consistently and

uniformly.

* * * * *

19. Paragraph (b) of Sec. 381.307 would be revised to read as

follows:

Sec. 381.307 Record review and maintenance.

* * * * *

(b) Automated process monitoring and recordkeeping. Automated

process monitoring and recordkeeping systems shall be designed and

operated in a manner which will ensure compliance with the applicable

requirements of Sec. 381.306.

* * * * *

20. In Sec. 381.308, paragraphs (b) would be revised, paragraph (c)

would be removed and reserved, and paragraph (d) introductory text

would be revised to read as follows:

Sec. 381.308 Deviations in processing.

* * * * *

(b) Deviations in processing (or process deviations) shall be

handled:

(1) Under a HACCP plan for thermally processed/commercially sterile

product that addresses hazards associated with microbial contamination;

or

(i) Under the provisions of paragraph (d) of this section; or,

(ii) Under a HACCP plan for thermally processed/commercially

sterile product that addresses hazards associated with microbial

contamination; or

(2) Until the establishment is subject to part 417 of this chapter,

(i) Under an FSIS-approved total quality control system; or

(ii) Under alternative documented procedures for handling process

deviations that will ensure that only product that is safe and stable

is shipped in commerce.

[[Page 26900]]

(c) [Reserved]

(d) Procedures for handling process deviations where the HACCP plan

for thermally processed/commercially sterile product does not address

food safety hazards associated with microbial contamination, where

there is no approved total quality control system, or where the

establishment has no alternative documented system or procedures for

handling process deviations.

* * * * *

21. In Sec. 381.309, paragraph (a) would be revised, paragraphs (b)

and (c) would be removed and reserved, and paragraph (d) introductory

text would be revised, to read as follows:

Sec. 381.309 Finished product inspection.

(a) Finished product inspections shall be handled:

(1) Under the provisions of paragraph (d) of this section;

(2) Under a HACCP plan for thermally processed/commercially sterile

products that addresses hazards associated with microbiological

contamination;

(3) Under an FSIS-approved total quality control system; or

(4) Under alternative documented procedures that will ensure that

only product that is safe and stable is shipped in commerce.

(b) [Reserved]

(c) [Reserved]

(d) Procedures for handling finished product inspections where the

HACCP plan for thermally processed/commercially sterile product does

not address food safety hazards associated with microbial

contamination, where there is no approved total quality control system,

or where the establishment has no alternative procedures for handling

finished product inspections.

* * * * *

Done at Washington, DC, on May 11, 1999.

Thomas J. Billy,

Administrator.

[FR Doc. 99-12352 Filed 5-17-99; 8:45 am]

BILLING CODE 3410-DM-P