[Federal Register: May 18, 1999 (Volume 64, Number 95)]

[Proposed Rules]               

[Page 26892-26900]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr18my99-21]



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Proposed Rules

                                                Federal Register

________________________________________________________________________



This section of the FEDERAL REGISTER contains notices to the public of 

the proposed issuance of rules and regulations. The purpose of these 

notices is to give interested persons an opportunity to participate in 

the rule making prior to the adoption of the final rules.



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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