[Federal Register Volume 62, Number 137 (Thursday, July 17, 1997)]
[Proposed Rules]
[Pages 38220-38222]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18841]


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 Proposed Rules
                                                 Federal Register
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 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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  Federal Register / Vol. 62, No. 137 / Thursday, July 17, 1997 / 
Proposed Rules  

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 317 and 381

[Docket No. 94-030P]
RIN 0583-AB98


Labeling of Natural or Regenerated Collagen Sausage Casings

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 
require the source labeling of natural sausage casings if they are 
derived from a different type of livestock or poultry than the meat or 
poultry in the enclosed sausage. FSIS is also proposing to require 
source labeling for regenerated collagen casings.

DATES: Comments must be received on or before September 15, 1997.

ADDRESSES: Submit an original and two copies of comments to: FSIS 
Docket Clerk, DOCKET #94-030P, Room 102, Cotton Annex, 300 C Street, 
SW, Washington, DC 20250-3700. Reference materials cited in this docket 
will be available for public inspection in the FSIS Docket Room from 
8:30 a.m. to 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Mr. William Hudnall, Assistant Deputy 
Administrator, Standards & Methods Review, Office of Policy, Program 
Development and Evaluation; (202) 205-0495.

SUPPLEMENTARY INFORMATION:

Background

    On July 18, 1994, FSIS was petitioned by the Office of the Attorney 
General of the State of Connecticut to adopt a regulation to require 
the identification of the origin of natural sausage casings on sausage 
offered for sale in commerce. The Attorney General was responding to a 
letter he had received from a Connecticut consumer describing the 
consumer's difficulty in attempting to ascertain the origin of a 
natural sausage casing.
    The consumer had gone to a local supermarket's butcher shop to 
purchase chicken and other non-pork sausages ``in packages the butcher 
shop makes in-house.'' Before purchasing any sausages, however, the 
consumer asked the butcher whether there was ``even a minuscule bit of 
pork anywhere in the sausage.'' The consumer was dismayed to learn that 
the casing surrounding a non-pork sausage could, in fact, be a pork 
casing and that no law or regulation required the origin of the casing 
to be on the sausage's label. In her letter to the Attorney General, 
the consumer observed that the failure of sausage manufacturers to 
label the origin of natural sausage casings had resulted in the 
unintended consumption of pork products by persons who, for religious 
reasons, did not want to consume them. On behalf of this consumer, the 
Attorney General of the State of Connecticut petitioned FSIS to require 
the identification of the origin of natural sausage casings. The 
Attorney General stated that he believes strongly that it is essential 
for a consumer to be provided with meaningful labeling information as 
to the nature and content of a sausage's casing, whether based upon 
dietary, religious or other factors.
    On August 25, 1995, the Religious Action Center of Reform Judaism 
submitted a similar petition to FSIS requesting that the nature of 
sausage casings (natural or regenerated) be identified on the label, as 
well as the species origin of the casings. The petitioner stated that 
religious concerns motivated the request for a more specific ingredient 
declaration. Referencing the issue raised by the Connecticut consumer, 
this petitioner stated that current federally-approved labels ``would 
not warn a religious Jew or Muslim that a sausage with chicken or veal 
contents is cased with pig collagen.'' This petitioner argued that 
``Federally-approved labels must warn consumers of the species of 
origin of collagen casing--the labels are the only means of preventing 
consumers from unknowingly consuming prohibited food products and 
removing uncertainty regarding the origin of food products.'' The 
petitioner went on to say that federally-approved labels should impart 
as much information as possible to health-conscious and interested 
consumers, ``whether such consumers are religious or non-religious.''
    Based on its review of these petitions, FSIS concluded that there 
was merit to the argument that consumers of sausages made with natural 
casings expect the casings to be derived from the same species as a 
species indicated on the product label. For example, consumers expect 
that the natural casing of a sausage labeled ``beef sausage'' to be 
derived from cattle. Similarly, FSIS believes that consumers of poultry 
sausage, e.g., chicken franks, expect the sausage to be made from 
poultry and do not expect the casing to be derived from a red meat 
source.
    However, sausages are not always encased in a casing derived from 
the same type of livestock or poultry as the meat block. They may be 
encased in natural casings that derive from a different type of 
livestock or poultry from that of the sausages. For example, a 
combination beef-and-lamb sausage may be made with a pork casing. 
Currently, in such a case, the manufacturer of the beef-and-lamb 
sausage is not required to disclose that the natural casing is not 
derived from the same type of livestock species as the sausage itself. 
(Poultry viscera are not currently used to encase sausages due to their 
small size.)
    FSIS has a broad array of food safety and other consumer protection 
responsibilities. In particular, FSIS has authority to regulate the 
processing and distribution of meat and poultry products to prevent the 
sale of misbranded products in interstate commerce (see 21 U.S.C. 601 
et seq. and 21 U.S.C. 451 et seq.). Under the Federal Meat Inspection 
Act (FMIA), the Poultry Products Inspection Act (PPIA), and the federal 
meat and poultry products inspection regulations, a meat or poultry 
product is ``misbranded'' if its labeling is false or misleading in any 
way.
    Having concluded that consumers could incorrectly assume that 
sausages made with natural casings or regenerated collagen casings are 
derived from the same species as a species indicated on the product 
label, the Agency informed the public of its labeling policies 
regarding those types of sausage casings. On July 31, 1996, FSIS 
published a ``Notice of Policy Statement'' in the Federal Register 
explaining FSIS's policy on the labeling

[[Page 38221]]

of meat or poultry sausages made with natural casings (61 FR 39853; 
July 31, 1996). That notice clarified FSIS's position that a sausage 
encased in a natural casing not obtained from the same type of 
livestock or poultry as the meat inside is misbranded under the FMIA or 
the PPIA unless the product is properly labeled to show the origin of 
the natural casing. If the casing is not obtained from the same type of 
livestock or poultry as the meat inside and the product is not properly 
labeled, it is misbranded.
    On October 9, 1996, the North American Natural Casing Association 
filed a lawsuit against the U.S. Department of Agriculture alleging in 
pertinent part that FSIS's July 31, 1996, policy notice violated the 
rulemaking procedures set forth in Sec. 553 of the Administrative 
Procedure Act (APA) (5 U.S.C. 553(e)). In response to this lawsuit, 
FSIS has reassessed the need for notice and comment rulemaking to 
clarify requirements for casings in the context of misbranding and, 
therefore, is proposing to codify the labeling requirements for natural 
and regenerated collagen casings. FSIS is also proposing to require 
that establishments that manufacture natural or regenerated collagen 
casings, and establishments that manufacture sausages encased in 
casings derived from a different type of livestock or poultry than the 
encased meat(s), keep records identifying the source of the casings. 
Pending completion of this rulemaking, FSIS is suspending enforcement 
of the July 1996 policy statement.

Natural Sausage Casings

    Natural animal casings have been traditional containers for sausage 
materials for centuries. Swine, sheep, and cattle are the primary 
sources for natural casings. Hog casings come from the stomach, the 
small and large intestines, and the rectum (bung). Cattle casings come 
from the esophagus (weasand), the small and large intestines, the bung, 
and the bladder. Sheep casings come only from the intestines. FSIS does 
not know of any natural casings derived from poultry sources.
    The manufacture of natural casings consists typically of washing, 
scraping, and treating the casings with chemicals to remove solubles 
and grading them for size and condition. The natural casings are then 
salted, packaged, and shipped in brine to the point of use. They can 
easily be detected on the product they encase and are useful because 
they allow smoke and moisture to permeate the sausage during 
processing. Natural casings are usually considered edible, and are 
eaten with the sausage they encase, except for the thicker, larger 
casings, which, while edible, are not eaten because of their toughness.

Regenerated Collagen Sausage Casings

    Sausage casings can also be manufactured from collagen. 
Manufactured collagen casings are made from collagen extracted from 
cattle hides or hog skins. A process called regeneration extracts the 
collagen from the hide. After being extracted, the collagen is 
dissolved and pushed out into a tube and hardened. It is then washed, 
swelled with acid, and formed. The final shape is fixed in an alkali 
bath.
    FSIS has tentatively decided to propose to require source labeling 
of regenerated collagen casings because consumers may be confused about 
the nature of sausages encased in such casings without that 
information. All establishments involved in the manufacture and use of 
regenerated collagen casings, from the facility extracting collagen 
from the hides to the facility receiving the regenerated collagen 
casings, plus any other establishments that might be included in the 
process, would be responsible for knowing the source of the hides from 
which the ``native'' collagen is removed. All establishments would be 
required to keep records indicating the livestock or poultry source of 
the regenerated collagen.
    However, the data currently available to the Agency indicates that 
regenerated collagen casings do not retain any of their original animal 
character. It is conceivable, therefore, that sausage manufacturers 
would not be able to determine the source of the regenerated collagen 
if the facility removing the ``native'' collagen does not itself keep a 
record of the source of the hides. This, in turn, would make it 
difficult for an FSIS inspector to verify the source of a regenerated 
collagen casing to determine if the encased sausage is mislabeled. FSIS 
believes, however, that all establishments, especially collagen 
extractors, keep records of this nature as a matter of course. 
Therefore, the Agency believes that this requirement will not impose a 
significant or undue burden on the industry.
    In light of the technical limits and practical difficulties that 
may exist in determining the source of regenerated collagen casings, 
FSIS is seeking comments concerning the feasibility of requiring 
establishments extracting collagen from hides and sausage manufacturers 
to identify the source of their regenerated collagen casings and 
whether imposing such a requirement would benefit consumers. FSIS is 
also interested in learning if a scientific test that can ascertain the 
source of a regenerated collagen casing has been or is being developed.

The Proposal

    FSIS is proposing 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 
livestock or poultry from which the casings were derived, such as beef, 
swine or sheep, if the casings are derived from a different type of 
livestock or poultry than any meat or poultry ingredient of the 
sausage. The manufacturer may place the identity of the sausage casing 
on the principal display panel or in the ingredient statement. 
Establishments that produce, manufacture or use natural or regenerated 
sausage casings would also be required to maintain records identifying 
the source of the casings.

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed rule is adopted: (1) all state 
and local laws and regulations that are inconsistent with this rule 
will be preempted; (2) no retroactive effect will be given to this 
rule; and (3) administrative proceedings will not be required before 
parties may file suit in court challenging this rule.

Executive Order 12866 and Regulatory Flexibility Act

    This proposal has been reviewed under Executive Order 12866. The 
rule has been determined to be not significant and, therefore, has not 
been reviewed by the Office of Management and Budget.
    In accordance with 5 U.S.C. 603, FSIS has performed an Initial 
Regulatory Flexibility Act, which is set out below, regarding the 
impact of the rule on small entities. However, FSIS does not currently 
have all the data necessary for a comprehensive analysis of the effects 
of this rule on small entities. Therefore, FSIS is inviting comments 
concerning potential effects. In particular, FSIS is interested in 
determining the number, kind and characteristics of small firms that 
may incur benefits or costs from implementation of this proposed rule.
    This proposed rule would require manufacturers of sausages encased 
in natural or regenerated collagen casings to label the source of those 
casings if the casings are derived from a different type of livestock 
or poultry than the encased sausage meat(s). However, FSIS believes

[[Page 38222]]

the associated labeling costs would be low. Manufacturers would be able 
to defer the development of new labels for sausage products in natural 
and regenerated collagen casings until their existing stocks of labels 
are exhausted. Moreover, the new labels could be generically approved; 
manufacturers would not have to prepare and submit FSIS Form 7234-1, 
``Application for Labels, Marking, or Device,'' or the new label. 
Identification of the source of natural sausage casings or regenerated 
collagen casings could also be a selling point for some manufacturers.
    This regulation would be beneficial to consumers because it would 
reduce confusion about the source of the casings surrounding those 
sausages and give them additional information with which to make 
informed choices about the sausages they purchase. Natural casings 
constitute between 15 and 20 percent of the sausage casing market; 
regenerated collagen casings constitute approximately 40 percent of 
that same market.

Paperwork Requirements

    Abstract: Under this proposed rule, sausage manufacturers would 
need to label the source of natural sausage casings or regenerated 
collagen casings if they are derived from a different type of livestock 
or poultry than the meat(s) in the enclosed sausage. These 
establishments would have to develop product labels in accordance with 
the proposed rule. FSIS would consider these labels to be generically 
approved in accordance with 9 CFR 317.5 and 381.133. Any burden 
associated with labeling changes would be approved under OMB number 
0583-0092.
    Establishments that produce, manufacture or use natural or 
regenerated sausage casings, or sausages encased in either of those 
types of casings would also be required to maintain records identifying 
the source of the casings. FSIS believes, however, that all of these 
establishments keep records of this nature as a matter of course.
    Estimate of Burden: Establishments producing, manufacturing or 
using natural or regenerated collagen casings, and establishments 
producing sausages encased in natural or regenerated sausage casings. 
FSIS estimates that the time associated with collecting the required 
information would be 15 minutes. FSIS estimates that this recordkeeping 
would occur once a day.
    Respondents: Meat and poultry establishments manufacturing natural 
or regenerated collagen sausage casings, and meat and poultry 
establishments manufacturing sausages encased in these types of 
casings.
    Estimated number of Respondents: 40 meat and poultry 
establishments.
    Estimated number of Responses per Respondent: 10,000.
    Estimated Total Annual Burden on Respondents: 2,500 hours.
    Comments are invited on: (a) whether the proposed 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. Comments may be sent to Lee Puricelli, 
Paperwork Specialist, see address above, and Desk Officer for 
Agriculture, Office of Information and Regulatory Affairs, Office of 
Management and Budget, Washington, DC 20253.

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 proposing to 
amend 9 CFR parts 317 and 381 of the Federal meat and poultry products 
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.

    2. Section 317.8 would be amended by adding a new paragraph (b)(37) 
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 
livestock or poultry viscera or regenerated collagen casings shall 
identify the type of livestock or poultry from which the casings were 
derived, if the casings are from a different type of livestock or 
poultry than the encased meat(s). 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 or regenerated collagen sausage casings shall maintain records 
documenting the livestock or poultry source in accordance with 
Sec. 320.3.

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

    3. The authority citation for part 381 would continue 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 would be amended by adding paragraph (f) to read 
as follows:


Sec. 381.117  Name of product and other labeling.

* * * * *
    (f) The labels of sausages encased in natural casings made from 
livestock or poultry viscera or regenerated collagen casings shall 
identify the type of livestock or poultry from which the casings were 
derived, if the casings are from a different type of livestock or 
poultry than the encased meat(s). 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 or regenerated collagen sausage casings shall maintain records 
documenting the livestock or poultry source in accordance with 
Sec. 381.177.

    Done at Washington, DC, on July 9, 1997.
Thomas J. Billy,
Administrator.
[FR Doc. 97-18841 Filed 7-16-97; 8:45 am]
BILLING CODE 3410-DM-P