[Federal Register Volume 65, Number 53 (Friday, March 17, 2000)]
[Proposed Rules]
[Pages 14486-14489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-6642]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 317, 318, 319, 381

[Docket No. 97-036A]


Other Consumer Protection (OCP) Activities

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is publishing 
this advance notice of proposed rulemaking to request comments on the 
need and desirability of revising its approach to verifying that meat 
and poultry products are not misbranded, economically adulterated, or 
otherwise unacceptable for reasons that do not necessarily raise food 
safety concerns. FSIS will refer to these program activities as ``other 
consumer protection'' (OCP) activities. This notice defines and 
describes FSIS' OCP activities and discusses the Agency's need for 
revised regulations and verification and enforcement procedures.

DATES: Comments must be received on or before June 15, 2000.

ADDRESSES: Submit one original and two copies of written comments to 
FSIS Docket Clerk, DOCKET #97-036A, U.S. Department of Agriculture, 
Food Safety and Inspection Service, Room 102 Cotton Annex Building, 300 
12th Street, SW., Washington, DC 20250-3700. FSIS has made a technical 
paper available in the FSIS Docket Room and on the FSIS homepage 
(www.fsis.usda.gov).

FOR FURTHER INFORMATION CONTACT: Daniel Engeljohn, Director, 
Regulations Development and Analysis Division, Food Safety and 
Inspection Service, Washington, DC 20250-3700, at (202) 720-5627.

SUPPLEMENTARY INFORMATION:  

Definition of Other Consumer Protections (OCP)

    As defined in the Federal Meat Inspection Act (FMIA) and the 
Poultry Products Inspection Act (PPIA), meat and poultry products are 
economically adulterated if any valuable constituent has been omitted 
or abstracted; any substance has been substituted; if damage or 
inferiority has been concealed in any manner; or if any substance has 
been added so as to increase its bulk or weight, or to reduce its 
quality or strength, or to make it appear better or of greater value 
than it is. Also, as defined in these Acts, meat and poultry products 
are misbranded if the labeling is false or misleading, or if the 
product purports to be a food for which there is a regulatory standard 
of identity, but the product fails to comply with that standard.
    FSIS conducts a range of activities to ensure that meat and poultry 
products are not economically adulterated, misbranded, or otherwise 
unacceptable for reasons that do not necessarily raise food safety 
considerations. Some OCP activities are based on specific regulatory 
requirements. These are the food labeling requirements (Parts 317 and 
381, Subpart N); definitions and standards of identify and composition 
(Parts 319 and 381, Subpart P); and the definitions of nonconformance 
and the finished product standards found in section 381.76. Other OCP 
activities are tied to specific regulations but are designed to verify 
that establishments are not producing economically adulterated or 
misbranded product as defined by the acts.
    FSIS activities directed at preventing misbranded product from 
reaching the consumer include label review activities, formulation 
verification checks, net weight checks, and laboratory food chemistry 
analyses. (Note: The presence of illegal drug residues is considered a 
food safety issue.) FSIS activities that are designed to ensure that 
products have not been economically adulterated by the addition or 
undeclared substitution of lower valued ingredients include weighing 
poultry carcasses to verify that water retention limits are not 
exceeded during immersion chilling.
    FSIS recognizes that its program activities do not fit cleanly into 
one of two well-defined categories, OCP and food safety. For example, 
while most consumers would view an unidentified ingredient as a 
misbranding issue, those with allergy concerns would view the same 
unidentified ingredient as a serious food safety concern. Similarly, 
many FSIS activities are related to enforcement of statutory provisions 
declaring that product is adulterated if it consists in whole or in 
part of any filthy, putrid, or decomposed substance or is for any other 
reason unsound, unhealthful, unwholesome, or otherwise unfit for human 
food. This provision speaks to both food safety and OCP concerns. FSIS 
conducts many activities to identify and prevent from entering commerce 
product that is unwholesome or unfit for human food but does not 
present a food safety concern. Examples of FSIS activities of this type 
include determining conformance with carcass Acceptable Quality Levels 
(AQL's)(e.g.,

[[Page 14487]]

checking the number of hairs remaining on the hide) and conducting 
boneless manufacturing meat reinspection tasks.
    In this ANPR, FSIS has defined OCP activities to include 
verification and enforcement activities that are directed to achieving 
objectives that do not necessarily, or primarily, involve food safety. 
Issues related to humane and religious exempt slaughter are not clearly 
OCP matters and, therefore are not addressed in this ANPR. Also, FSIS 
will address all issues related to egg products in future proposed 
rulemaking. In an effort to provide the public with more information 
about the Agency's current OCP activities and to illustrate the need 
for change, FSIS has made a technical paper available in the FSIS 
Docket Room (See ADDRESSES) and the FSIS homepage (www.fsis.usda.gov).

Need for Change

    FSIS intends to propose change to its approach to OCP activities 
for three reasons. First, the Agency needs to clarify the respective 
roles and responsibilities of FSIS and industry. Second, the Agency 
needs to use the resources allocated to OCP activities more 
efficiently. Third, the Agency needs to be more accountable to the 
public on how it allocates its OCP resources and on the results that 
are being achieved.
    The first reason for changing the Agency's approach to OCP 
activities is to clarify roles and responsibilities. As FSIS described 
in the preamble to its Pathogen Reduction; Hazard Analysis and Critical 
Control Point (PR/HACCP) final rule (61 FR 38806, 7/26/96), the 
responsibilities of FSIS and industry have become blurred. In part, 
this blurring has developed because some establishments rely on 
inspection program personnel to find deficiencies. It is more 
appropriate that inspected establishments take responsibility for 
meeting the regulatory requirements, and that FSIS personnel verify 
that establishments do so.
    Responsibilities have also been blurred because of the excessive 
reliance of the FSIS inspection program on the detection and correction 
of problems after the fact, rather than on assurance that problems will 
be prevented systematically and by design in the first place.
    The second reason for changing its approach to OCP activities is 
the need for FSIS to manage and allocate its resources more effectively 
and efficiently. In most cases, inspection program personnel routinely 
perform OCP verification activities at the same frequency in all 
plants. FSIS is considering that a more suitable use of inspection 
resources would be to base the rate of these verification checks on the 
compliance history of a particular establishment.
    Finally, FSIS intends to change its approach to OCP activities to 
improve program accountability. By ``improving accountability,'' FSIS 
seeks to improve its measure of establishments'' compliance and its 
ability to inform the public about the industry's overall compliance 
with OCP requirements. Accountability also implies having more 
consistent and effective methods for making resource allocation 
decisions and explaining those decisions to all interested parties.
    FSIS intends to develop an approach to OCP that measures 
compliance, targets the Agency's inspection resources, and provides 
program accountability.

Possible Approaches

    FSIS is not contemplating a reduction in the level of attention 
that it pays to misbranding, economic adulteration, or wholesomeness 
issues. FSIS remains committed to protecting consumers from economic 
adulteration and improperly labeled products.
    In preparing this ANPR, FSIS began with the premise that consumer 
protection concerns other than food safety are important to consumers, 
and that the public expects the Agency to provide a broad range of 
consumer protections that involve more than ensuring food safety.
    This section outlines the changes that FSIS is evaluating and that 
will most likely be needed for FSIS to continue to protect consumers 
from economic adulteration, misbranding, and unwholesome products while 
enhancing food safety. These changes will likely occur in the four 
following areas:
    1. Revision of FSIS regulations and guidance.
    2. Inspected establishments taking more responsibility for 
producing products that comply with all OCP requirements.
    3. Changes to FSIS verification activities.
    4. Changes in approach to enforcement.

1. Revisions to FSIS Regulations

    The change in approach to OCP activities will require that the 
Agency reform its regulations. Certain current regulations charge FSIS 
with responsibilities that more appropriately belong to the industry. 
For example, at the time when FSIS established the compliance 
monitoring system for cured pork products (9 CFR 381.19) the Agency's 
approach was to assume responsibility for ensuring establishments' 
compliance. Therefore, the system effectively became a government run 
quality control system. The regulations implementing the system go so 
far as to provide an exemption for establishments that take 
responsibility and institute their own quality control procedures. 
(Note: Published elsewhere in this issue of the Federal Register, FSIS 
is proposing to withdraw the regulations that prescribe the compliance 
monitoring system for cured pork products.)
    FSIS will also carefully evaluate its prior label approval program 
and consider streamlining its label approval programs. The Agency also 
intends to consider what use, if any, it should continue to make of the 
Standards and Labeling Policy Book.
    The Agency also intends to consider its role in ensuring the 
soundness and wholesomeness of raw products. As noted earlier, none of 
the product quality criteria for meat carcasses or raw meat products 
are published as regulations. The Agency requests comments on whether 
FSIS' regulations should contain quality criteria and if so, what the 
criteria should be.
    The Agency has already initiated a review of the standards of 
identity and composition for meat products and poultry products. The 
Agency published an ANPR on September 9, 1996 (61 FR 47453). While that 
ANPR focused on the continuing need for the standards of identity and 
composition, it noted that, in light of budget constraints and the need 
to address higher priority food safety concerns, the Agency was 
examining whether any of its approaches to regulating meat products and 
poultry products for economic adulteration and mislabeling should be 
changed.
    The Agency recognizes that some of its regulations are overly 
prescriptive in telling industry how it must comply with certain 
standards. For example, the Mechanically Separated (Species)(MS(S)) 
regulations (9 CFR 319.5) specify how many samples an establishment 
needs to analyze to ensure compliance. The Agency intends to institute 
rulemaking to revise these regulations. FSIS has tentatively concluded 
that the purposes for which it adopted these regulations can be 
achieved by the standards of composition that are already included in 
the regulations. The Agency also has proposed the removal of 
regulations that require Partial Quality Control (PQC) programs for 
specific production activities, such as the production of MS(s).

[[Page 14488]]

2. Changes to FSIS Verification Activities

    FSIS is responsible for verifying that industry is complying with 
regulatory requirements. A verification activity can have a narrow 
establishment-by-establishment focus or an industry-wide scope. FSIS 
believes that it can operate more efficiently and effectively by making 
greater use of surveys.
    A verification survey can involve either collecting product samples 
that are sent to laboratories for analysis or conducting in-plant 
activities such as formulation checks. Collecting product labels that 
are sent to a central location for review is another type of 
verification survey. The survey approach to verification allows the 
Agency to: (1) draw conclusions about overall industry compliance, (2) 
inform the public, i.e., improve ``accountability,'' and (3) use such 
industry-wide findings as inputs to subsequent resource allocation 
decisions.
    Surveys are not, however, sufficient to verify compliance at 
individual establishments. The Agency intends to use surveys and other 
information resources to target establishments where overall compliance 
with OCP requirements is not satisfactory. In these establishments, 
FSIS could focus verification activities on specific products and 
specific requirements.
    FSIS' approach to OCP verification has historically been to select 
a task or sampling frequency for a specific regulatory requirement, 
e.g., once per week or once per shift, and then apply that fixed 
frequency to all establishments where the requirement applies. To 
improve the effectiveness of verifying establishments' compliance with 
OCP requirements, FSIS needs to conduct inspection procedures and 
collect samples at the point in the production and distribution process 
where doing so is most efficient, and where taking these actions makes 
the most sense.
    The concepts of measuring the level of compliance, or evaluating 
whether a particular level of compliance is acceptable or unacceptable, 
have not been adequately incorporated into FSIS regulatory design 
initiatives. FSIS must devise a more comprehensive and methodical 
approach to verification that would involve the sequential steps of: 
(1) Measuring compliance; (2) evaluating the level of compliance to 
determine causes of noncompliance, and whether there are feasible 
interventions that might be effective in improving compliance; (3) 
implementing interventions; and, (4) reassessing the overall level of 
compliance.
    For example, FSIS has considered using a ``building-block'' 
approach to net weight compliance that has been advanced by the Codex 
Alimentarius Commission. This approach is modeled on a statistical 
limits of variance technique developed by Switzerland for application 
to imported, prepackaged foods. Inspection program personnel would make 
limited inspections for net weight compliance at retail. If the 
sampling technique indicates a compliance problem, additional 
inspection of the same product would be made at retail and, if 
necessary earlier in the marketing chain, such as the processing plant. 
If the problem continues following notification of the producers, a 
more precise enforcement test would be applied. This approach should 
lead to a more efficient and effective verification system.
    Another potential innovation for verification would involve the 
development of an annual OCP verification plan. Annual plans would 
describe and assess findings from the previous year, consider the 
applicability of findings from ongoing research projects, and define 
areas of emphasis for the current year. FSIS is developing a list of 
factors to be considered in setting OCP priorities. These factors would 
include findings from consumer research and findings from analysis of 
consumer and industry complaints.
    FSIS also believes it is practical to solicit and use input from 
its inspection program personnel in setting its OCP priorities.
    Additionally, FSIS could use consumer research to help set its 
priorities for verifying the industry's OCP compliance. FSIS could use 
existing consumer research such as surveys compiled by trade 
organizations or develop its own consumer surveys to determine whether 
consumers are concerned about any particular OCP issues. Based on the 
findings, FSIS could use this information to focus its OCP verification 
activities. This approach would be responsive to consumer concerns.
    The above examples are intended to illustrate the kinds of 
approaches that the Agency is considering for OCP verification. 
Whatever final decisions it makes, the Agency's verification activities 
must:
     Yield data that will allow the Agency to draw accurate 
conclusions about establishments' compliance.
     Permit the Agency to allocate inspection and laboratory 
resources to product categories that have been shown to present 
compliance problems, while requiring inspected establishments to 
maintain satisfactory control of their production processes and 
products.
     Provide appropriate bases for enforcement actions against 
establishments or companies producing and shipping economically 
adulterated or misbranded products.
     Accommodate any changes to the system of product standards 
of identity that the Agency may adopt.

3. Changes in Enforcement Approach

    FSIS also needs to change its enforcement approach to repeated 
noncompliance with OCP requirements. FSIS will evaluate each OCP 
noncompliance in terms of an establishment's overall compliance record 
to determine whether the establishment has an effective system in place 
to ensure compliance with all OCP requirements and standards. For 
example, the Agency will not view added water noncompliance as 
independent from species substitution noncompliance or independent from 
noncompliance with fat and protein requirements.
    FSIS is examining how best to communicate to establishments its 
findings of noncompliance and FSIS' conclusions regarding the adequacy 
of the establishment's control system. The role of FSIS is to verify 
compliance and take enforcement actions when the overall level of OCP 
noncompliance reaches a level that indicates that an establishment is 
not controlling its OCP processes effectively.

Issues for Public Comment

    FSIS is soliciting comments on all aspects of its OCP activities. 
FSIS requests comments from all interested parties, including 
individuals, consumer groups, inspected establishments and industry 
groups, academia, importers and exporters, State and local governments, 
and the international community. The following questions are provided 
to facilitate public comment on this ANPR.
    1. What level of resources should FSIS allocate to OCP program 
activities? What criteria should FSIS consider in allocating its 
resources between food safety and OCP issues?
    2. What role, if any, should the Agency have in examining raw 
product for quality defects?
    3. What priorities should FSIS give to misbranding concerns? For 
example, should the presence of excess sodium take priority over a 
misleading picture on a label?
    4. Should FSIS continue testing products to determine compliance 
with

[[Page 14489]]

requirements related to fat content or water retention, or whether the 
product is fresh or frozen? If so, how should FSIS prioritize the 
sampling of products?
    5. Should FSIS consider which OCP issues concern consumers? If so, 
how could FSIS determine this? For example, are there existing data 
FSIS can use or should FSIS conduct its own consumer surveys? To what 
extent should FSIS use information about consumers' concerns to 
prioritize the verification of the industry compliance with the OCP 
requirements?
    6. How should FSIS weigh the severity of noncompliance that leads 
to public health concerns versus noncompliances related to OCP 
concerns? What sanctions or penalties are appropriate for economic 
adulteration? How should FSIS deal with establishments that demonstrate 
no deliberate intent to cheat the public but experience intermittent 
problems of noncompliance that result in misbranding or economic 
adulteration?
    7. What enforcement strategy is appropriate for addressing 
noncompliance with OCP requirements? What portion of the Agency's 
enforcement resources should be allocated to OCP concerns? What levels 
of noncompliance with OCP requirements warrant the use of severe 
sanctions, such as withholding the marks of inspection?
    8. The Agency believes that inspected establishments need to have 
systems, i.e., quality control systems, managerial systems, or 
administrative systems, that ensure compliance with OCP requirements. 
Should FSIS consider promulgating a general process control regulation, 
or are there alternatives to such a regulation that would still enable 
the Agency to effectively and efficiently verify that an 
establishment's control systems for OCP requirements are satisfactory?

Executive Order 12866 and Regulatory Flexibility Act

    This advance notice of proposed rulemaking has been reviewed under 
Executive Order 12866. This rule has been determined to be significant 
for the purposes of Executive Order 12866 and, therefore, has been 
reviewed by the Office of Management and Budget.
    FSIS is seeking the data necessary to assess how the regulatory 
changes discussed in this document might affect various sectors of the 
meat and poultry industries. Therefore, the Agency invites comment on 
potential effects, including economic costs or benefits.

Departmental Regulation 4300-4, ``Civil Rights Impact Analysis''

    Pursuant to Department Regulation 4300-4, ``Civil Rights Impact 
Analysis,'' dated September 22, 1993, FSIS will conduct a civil rights 
impact analysis on any proposed rule that results from this ANPR. To 
improve the Agency's analysis, FSIS is seeking the data necessary to 
assess how the resulting regulatory changes discussed in this document 
might affect minorities, women, and persons with disabilities.
    ANPR's generally are designed to provide information and receive 
public comments on substantive issues that may lead to new or revised 
agency regulations or instructions. Public involvement in all segments 
of rulemaking and policy development is important. Consequently, in an 
effort to better ensure that minorities, women, and persons with 
disabilities are made aware of this ANPR and are informed about the 
mechanism for providing their comments, FSIS will announce it and 
provide copies of this Federal Register publication in the FSIS 
Constituent Update.
    FSIS provides a weekly FSIS Constituent Update, which is 
communicated via fax to over 300 organizations and individuals. In 
addition, the update is available on line through the FSIS web page 
located at http://www.fsis.usda.gov. The update is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register Notices, FSIS public meetings, recalls, and any other types of 
information that could affect or would be of interest to our 
constituents/stakeholders. The constituent fax list consists of 
industry, trade, and farm groups, consumer interest groups, allied 
health professionals, scientific professionals and other individuals 
that have requested to be included. Through these various channels, 
FSIS is able to provide information with a much broader, more diverse 
audience. For more information and to be added to the constituent fax 
list, fax your request to the Office of Congressional and Public 
Affairs, at (202) 720-5704.
    FSIS will use a variety of methods to reach consumers and those 
individuals who work directly with consumers--information multipliers--
to publicize the issues identified in this OCP ANPR. FSIS will send 
electronic messages to electronic discussion lists that reach thousands 
of educators, health professionals, media, industry representatives, 
and consumers. FSIS will use Department mailing lists for minority 
media and constituent groups to send information releases that can be 
published in local newspapers. In addition, FSIS intends to translate 
briefing materials and consumer information into Spanish in order to 
encourage publication in non-English media that directly reach 
consumers.
    FSIS expects to arrange for one or more public meetings to be held 
in large urban areas with diverse populations in order to encourage 
public participation by individuals not typically represented by 
consumer-organizations or who do not have access to electronic 
communication, including fax machines, internet-accessible equipment, 
televisions, radios, or non-English printed materials.
    FSIS does not expect that this ANPR or resulting rulemaking will 
have an adverse effect on its own employees since the ratio of tasks 
performed on OCP activities will be shifted more in favor of tasks 
performed on food safety activities.

    Done at Washington, D.C., March 13, 2000.
Thomas J. Billy,
Administrator.
[FR Doc. 00-6642 Filed 3-16-00; 8:45 am]
BILLING CODE 3410-DM-P