[Federal Register: August 6, 2001 (Volume 66, Number 151)]
[Rules and Regulations]
[Page 40843-40845]
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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