[Federal Register Volume 66, Number 151 (Monday, August 6, 2001)]
[Rules and Regulations]
[Pages 40843-40845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-19598]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 317 and 381

[Docket No. 94-030F]
RIN 0583-AC80


Labeling of Natural or Regenerated Collagen Sausage Casings

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is requiring 
that the source of natural sausage casings be disclosed on the product 
label if the casings are derived from a different type of meat or 
poultry than the meat or poultry encased in the sausage. Establishments 
producing, manufacturing, or using natural sausage casings are also 
required to maintain records documenting the source of the casings. 
FSIS is requiring that the labels of sausage products encased in 
regenerated collagen casings disclose the use of the regenerated 
collagen casing. However, FSIS is not requiring that records on the 
source of regenerated collagen casings be kept.

EFFECTIVE DATE: September 5, 2001. Manufacturers may use their existing 
label stocks until exhausted.

FOR FURTHER INFORMATION CONTACT: Robert Post, Ph.D., Director, Labeling 
and Consumer Protection Staff, Office of Policy, Program Development 
and Evaluation; (202) 205-0279.

SUPPLEMENTARY INFORMATION:

Background

    On July 17, 1997, FSIS published a proposed rule in the Federal 
Register (62 FR 38220) to amend the Federal meat and poultry products 
inspection regulations to require that labels of sausages encased in 
natural casings or regenerated collagen casings identify the type of 
meat or poultry from which the casings were derived, such as beef, 
swine, or sheep, if the casings were derived from a different type of 
meat or poultry than any meat or poultry ingredient of the sausage. 
FSIS also proposed to require that establishments that produce, 
manufacture, or use natural or regenerated sausage casings maintain 
records identifying the source of the casings.
    FSIS received 30 comments during the comment period that ended on 
September 15, 1997. Two additional comments were received after that 
comment period closed; however these were also included as part of the 
administrative record.
    Eleven favorable comments were submitted by individual consumers, 
religious organizations, and a member of the House of Representatives.
    The groups that supported the proposal felt that people have a 
right to know what they eat, whether for health, religious, or other 
reasons, and that the proposal would allow health-conscious and 
interested consumers to accurately identify foods with substances to 
which they are allergic or food that they did not want to consume.
    Twenty-one comments were opposed to the proposal. These comments 
were from the sausage casings industry, the meat and poultry industry, 
and a law firm.
    The industry comments that opposed the proposal argued that it 
would not provide all consumers with more information but, rather, 
would only enable consumers with specific religious dietary concerns to 
avoid eating casings derived from a different species than the encased 
meat or poultry block. They asserted that the proposal was not based on 
a food safety issue. These comments argued that the people with dietary 
concerns could rely on a private mechanism, such as Kosher or Halal 
certification, to ensure that they do not consume non-pork sausages 
that are encased with a pork-derived casing.
    While FSIS agrees that buying Kosher or Halal certified products 
ensures that individuals who do not want to eat pork can comply with 
religious requirements, FSIS disagrees that the purpose of the proposal 
was solely to provide a limited number of individuals with information 
concerning dietary requirements. The intent of the rule is to ensure 
that all consumers, not just consumers with religious interests, are 
not misled into believing that they are purchasing a product composed 
entirely of one species, e.g., beef, when, in fact, it is in a sheep or 
pork casing. Thus, the rule requires the disclosure of a material fact 
about the nature of the product.
    Some commenters opposing the proposal also stated that if FSIS 
believed that consumers have a ``right to know'' what they eat, then 
FSIS should require that labels of sausage products disclose all 
ingredients, including gelatin, amino acids, and proteins. One casing 
manufacturer pointed out that the proposal is inconsistent with FSIS 
and Food and Drug Administration policy, which does not require source 
labeling, in general.
    The purpose of the proposal was not to address the ``right to 
know'' for all ingredients in sausages. FSIS's proposal was narrowly 
crafted to address a situation where consumers may be misled.
    FSIS is, therefore, requiring the source labeling of natural 
sausage casings, if they are derived from a different type of meat or 
poultry than the meat or poultry encased in the sausage. FSIS is also 
requiring establishments producing, manufacturing, or using natural 
sausage casings to maintain records documenting the source of the 
casings.
    With regard to the proposed requirements for regenerated collagen 
casings, several commenters from the meat and poultry industry and the 
sausage casings' industry opposed the labeling and recordkeeping 
requirements for regenerated collagen casings. These commenters stated 
that the processing of regenerated collagen casings renders the 
detection of identifiable species protein impossible.
    FSIS agrees with the comments in part. Therefore, FSIS is amending 
the meat and poultry product regulations to require that the labels of 
sausage products encased in regenerated collagen casings disclose the 
use of the regenerated collagen casing, but not the source of the 
casing. FSIS understands that the processing of regenerated collagen 
casings renders the detection of the species protein impossible; 
therefore, no recordkeeping for collagen casings is required.
    FSIS concludes that providing the information that the casing is 
from regenerated collagen will indicate to consumers that they are 
purchasing a sausage product with a casing not necessarily made from 
the same type of meat or poultry enclosed in the casing. Thus, this 
material fact about the nature of the product would be disclosed, and 
the product would not be misbranded.

[[Page 40844]]

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. States and local jurisdictions are preempted by 
the Federal Meat Inspection Act (FMIA) and the Poultry Products 
Inspection Act (PPIA) from imposing any marking, labeling, packaging, 
or ingredient requirements on federally inspected meat and poultry 
products that are in addition to, or different from, those imposed 
under the FMIA and the PPIA. States and local jurisdictions may, 
however, exercise concurrent jurisdiction over meat and poultry 
products that are within their jurisdiction and outside official 
establishments for the purpose of preventing the distribution of meat 
and poultry products that are misbranded or adulterated under the FMIA 
and PPIA, or, in the case of imported products, that are not at such an 
establishment, after their entry into the United States.
    This final rule is not intended to have retroactive effect.
    Under this rule, administrative proceedings will not be required 
before parties may file suit in court challenging this rule. However, 
the administrative procedures specified in 9 CFR 306.5 and 381.35 must 
be exhausted prior to any judicial challenge of the application of the 
provisions of this rule, if the challenge involves any decision of an 
FSIS employee relating to any matters under the FMIA and the PPIA.

Executive Order 12866 and Regulatory Flexibility Act

    This final rule has been determined to be not significant and 
therefore has not been reviewed by OMB under Executive Order 12866.
    In accordance with 5 U.S.C. 603, FSIS performed a regulatory 
flexibility analysis, which is set out below, regarding the impact of 
the rule on small entities. FSIS invited comments concerning potential 
effects on the number, kind and characteristics of small firms that 
would incur benefits or costs from implementation of this rule.
    This final rule will require manufacturers of sausages encased in 
natural casings to label the source of those casings, if the casings 
are derived from a different type of meat or poultry than the encased 
sausage meat or poultry. This rule will also require that sausages 
encased in a regenerated collagen casing have a statement on the label 
indicating that the casing is regenerated collagen. FSIS believes the 
associated labeling costs will be low. Manufacturers will be able to 
defer the development of new labels for sausage products in natural 
casings and regenerated collagen casings until their existing stocks of 
labels are exhausted. Moreover, the new labels can be generically 
approved; manufacturers will not have to prepare and submit FSIS Form 
7234-1, ``Application for Labels, Marking, or Device,'' or the new 
label for approval. Identification of the source of natural sausage 
casings may also be a selling point for some manufacturers.
    This regulation will be beneficial to consumers because it will 
reduce confusion about the source of the casings on sausages and give 
them additional information with which to make informed choices about 
the sausages they purchase.

Paperwork Requirements

    The paperwork and recordkeeping requirements in this final rule 
have been approved on an emergency basis by OMB under control number 
0583-0119. FSIS is seeking comments on the paperwork and recordkeeping 
requirements in this rule so that the Agency may receive a three year 
approval for these requirements.
    Abstract: Under this final rule, sausage manufacturers will need to 
label the source of natural sausage casings if they are derived from a 
different type of meat or poultry than the meat or poultry encased in 
the sausage and sausage products encased in regenerated collagen 
casings will have to have a statement on the label disclosing the use 
of regenerated collagen casings. FSIS will consider the labels they 
develop to make these declarations to be generically approved in 
accordance with 9 CFR 317.5 and 381.133.
    Establishments producing, manufacturing, or using natural sausage 
casings, or sausages encased in natural casings, will be required to 
maintain records documenting the source of the casings.
    Estimate of Burden: FSIS estimates that it will take 15 minutes for 
establishments to make the appropriate labeling changes. FSIS estimates 
that the recordkeeping for the origin of the casing will occur once a 
day and take establishments 2 minutes to complete.
    Respondents: Establishments manufacturing natural and regenerated 
collagen sausage casings, and establishments manufacturing sausages 
encased in natural and regenerated collagen casings.
    Estimated number of Respondents: 40 meat and poultry 
establishments.
    Estimated number of Responses per Respondent: 10,000
    Estimated Total Annual Burden on Respondents: 344 hours.
    Comments are invited on: (a) Whether the final collection of 
information is necessary for the proper performance of the functions of 
the Agency, including whether the information will have practical 
utility; (b) the accuracy of the Agency's estimate of the burden of the 
proposed collection of information including the validity of the 
methodology and assumptions used; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of collection of information on those who are to 
respond, including through use of appropriate automated, electronic, 
mechanical, or other technological collection techniques or other forms 
of information technology.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to better ensure 
that minorities, women, and persons with disabilities are aware of this 
final rule, 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 to a much broader, more diverse audience. For more 
information and to be added to the constituent fax list, fax your 
request to the Congressional and Public Affairs Office, at (202) 720-
5704.

List of Subjects

9 CFR Part 317

    Food labeling, Food packaging, Meat inspection.

9 CFR Part 381

    Food labeling, Poultry and poultry products.

    For the reasons discussed in the preamble, FSIS is amending 9 CFR 
parts 317 and 381 of the Federal meat and

[[Page 40845]]

poultry products inspection regulations as follows:

PART 317--LABELING, MARKING DEVICES, AND CONTAINERS

    1. The authority citation for part 317 continues to read as 
follows:

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


    2. Section 317.8 is amended by adding new subparagraphs (b)(37) and 
(b)(38) to paragraph (b) to read as follows:


Sec. 317.8  False or misleading labeling or practices generally; 
specific prohibitions and requirements for labels and containers.

* * * * *
    (b) * * *
    (37) The labels of sausages encased in natural casings made from 
meat or poultry viscera shall identify the type of meat or poultry from 
which the casings were derived, if the casings are from a different 
type of meat or poultry than the encased meat or poultry. The identity 
of the casing, if required, may be placed on the principal display 
panel or in the ingredient statement. Establishments producing, 
manufacturing, or using natural sausage casings are to maintain records 
documenting the meat or poultry source in accordance with part 320 of 
this chapter.
    (38) The labels of sausages encased in regenerated collagen casings 
shall disclose this fact on the product label. The fact that the 
sausage is encased in collagen may be placed on the principal display 
panel or in the ingredient statement.

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

    3. 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.


    4. Section 381.117 is amended by adding paragraphs (f) and (g) to 
read as follows:


Sec. 381.117  Name of product and other labeling.

* * * * *
    (f) The labels of sausages encased in natural casings made from 
meat or poultry viscera shall identify the type of meat or poultry from 
which the casings were derived, if the casings are from a different 
type of meat or poultry than the encased meat or poultry. The identity 
of the casing, if required, may be placed on the principal display 
panel or in the ingredient statement. Establishments producing, 
manufacturing, or using natural sausage casings are to maintain records 
documenting the meat or poultry source in accordance with subpart Q of 
this part.
    (g) The labels of sausages encased in regenerated collagen casings 
shall disclose this fact on the product label. The fact that the 
sausage is encased in collagen may be placed on the principal display 
panel or in the ingredient statement.

    Done at Washington, DC, on July 31, 2001.
Thomas J. Billy,
Administrator.
[FR Doc. 01-19598 Filed 8-3-01; 8:45 am]
BILLING CODE 3410-DM-P