[Federal Register Volume 62, Number 50 (Friday, March 14, 1997)]
[Proposed Rules]
[Pages 12117-12119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6447]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 318
[Docket No. 95-052P]
RIN 0583-AC02
Use of Sorbitol in Cooked Roast Beef Products
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 Federal meat inspection regulations to add cooked roast beef
products to the list of products in which sorbitol is permitted. FSIS
proposes this action in response to a petition requesting that FSIS
allow the use of sorbitol, both to sweeten and to reduce charring in
cooked roast beef products, at the level of up to 2 percent of the
product formulation. The sorbitol would be added to a solution of
ingredients that are pumped into the beef prior to cooking.
DATES: Comments must be received on or before May 13, 1997.
ADDRESSES: Send an original and two copies of written comments to: FSIS
Docket Clerk, Docket 95-052P, Room 3806, South Agriculture
Building, 1400 Independence Avenue, SW., Washington, DC 20250-3700.
Reference material cited in this document and any comments received in
response to this proposal will be available for public inspection in
the FSIS Docket Room from 8:30 a.m. to 1:00 p.m., and from 2:00 p.m. to
4:30 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Charles R. Edwards, Director, Product
Assessment Division, Regulatory Programs, (202) 418-8900.
SUPPLEMENTARY INFORMATION:
FSIS was petitioned to allow the use of sorbitol in cooked roast
beef products in the amount currently approved for use in other meat
and meat food products. The petitioner requested that FSIS amend
Sec. 318.7(c)(4) of the Federal meat inspection regulations to allow
the use of sorbitol both to sweeten and to reduce charring in cooked
roast beef products in an amount not to exceed two percent of the
product formulation, excluding the formula weight of water or ice. The
sorbitol would be added to a solution of ingredients that are pumped
into the beef prior to cooking.
Sorbitol is a common sugar alcohol; it can be found in apples,
pears, and other foods. About half as sweet as sucrose (i.e., sugar),
it is often used as a
[[Page 12118]]
substitute sweetener in reduced-sugar products such as sugar-free candy
and other food products for diabetics. Sorbitol is listed in 21 CFR
184.1835 by the Food and Drug Administration (FDA) as a substance
affirmed as generally recognized as safe for use as an anticaking
agent, humectant, flavoring agent, and for various other uses, when
used in accordance with good manufacturing practices. Sorbitol does not
possess the same chemical makeup as do sugars that caramelize, i.e.,
brown and char in the presence of high heat. It is this characteristic
of sorbitol that reduces charring in cooked roast beef products and
other meat products in which it is used.
The petitioner conducted informal sensory testing using various
levels of sorbitol in roast beef product formulations. Tests were
conducted by using informal visual and taste panels. A panel of eight
people measured the amount of charring that took place on roast beef
products treated with sorbitol by evaluating the browning of products
after they were treated and cooked. Another panel of eight measured the
sweetness of the products by tasting the test products after they were
treated and cooked. The test data show that two percent sorbitol both
reduces charring and achieves a suitable level of sweetness.
After reviewing the petitioner's technical data and information,
the Administrator, FSIS, determined that the technical data and
information submitted with the petition demonstrated the efficacy of
sorbitol for these uses at the level not to exceed two percent of
product formulation.
The Administrator determined that these uses of sorbitol (1) will
not render the product adulterated or misbranded, or otherwise not in
compliance with the requirements of the Federal Meat Inspection Act and
(2) is functional and suitable for the product, and is permitted at the
lowest level necessary to accomplish the stated effect. To permit these
uses of sorbitol, the chart of approved substances in the meat
inspection regulations (9 CFR 318.7(c)(4)) must be amended.
FSIS published a direct final rule in the Federal Register on
February 27, 1996 (61 FR 7207), that would have added new uses of
sorbitol both to sweeten and to reduce charring in cooked roast beef
products up to a level of two percent of the product formulation.
FSIS solicited comments concerning the direct final rule for a 30-
day period ending March 28, 1996. FSIS stated that the effective date
of the proposed amendment would be 60 days after publication of the
direct final rule in the Federal Register, unless the Agency received
written adverse comments or a notice of intent to submit adverse
comments by the close of the comment period. FSIS also stated that if
it received written adverse comments or a notice of intent to submit
adverse comments, it would publish a document in the Federal Register
withdrawing the direct final rule before the scheduled effective date
and would publish a proposed rule for public comment.
On April 16, 1996 (61 FR 16617), FSIS withdrew the direct final
rule because it received one adverse comment from a consumer who
opposed adding cooked roast beef to the list of products in which
sorbitol is permitted. The comment contended that, while sorbitol is
generally recognized as safe, increasing numbers of people have
reactions to ingredients ``hidden in prepared foods.'' The currently
permitted use of this substance, as specified in the regulations,
complies with applicable requirements of the Food and Drug
Administration (FDA).
Its proposed use in roast beef would also be in compliance with those
requirements, as are current allowances for cured pork products and
sausages. FSIS is aware of the needs of consumers who are sensitive to
certain ingredients and requires the labels of all products under its
jurisdiction to convey information that is useful to consumers,
including the common or usual names of all ingredients used to make the
food. Under this proposal, sorbitol would have to be listed in the
ingredients statements of cooked roast beef products as well as in
ingredients statements of the other products in which it is already
permitted. This listing would provide sufficient information to
consumers who are sensitive to sorbitol or who have other reasons for
selecting sorbitol-free products. Therefore, FSIS is proposing to amend
the chart of approved substances in 9 CFR 318.7 (c)(4) to add the use
of sorbitol both to sweeten and to reduce charring in cooked roast beef
products at a level of up to two percent of product formulation.
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 proposed rule has been determined to be not significant and
has not been reviewed by the Office of Management and Budget.
The Administrator has made an initial determination that this
proposed rule would not have a significant economic impact on a
substantial number of small entities, as defined by the Regulatory
Flexibility Act (5 U.S.C. 601). The proposed rule would permit the use
of sorbitol to sweeten and to reduce charring in cooked roast beef
products. The sorbitol would be added to a solution of ingredients that
are pumped into the beef prior to cooking. This amendment would provide
cooked roast beef processors with an additional, alternative substance
that can be used to sweeten their product while at the same time to
reduce charring that may occur during the cooking process. The use of
sorbitol to sweeten and to reduce charring in cooked roast beef
products would be voluntary. Small manufacturers opting to use sorbitol
for these purposes would be required to revise their product labels.
Decisions by individual manufacturers on whether to do so would be
based on their conclusions that the benefits outweigh the costs.
Paperwork Requirements
Abstract: FSIS has reviewed the paperwork and recordkeeping
requirements in this proposed rule in accordance with the Paperwork
Reduction Act. This rule would require manufacturers opting to use
sorbitol to sweeten and to reduce charring in cooked roast beef
products to revise their product labels and submit such labeling to
FSIS for approval.
Estimate of Burden: Establishments would have to develop product
labels in accordance with the proposed rule. To receive approval of the
labels, establishments would complete FSIS Form 7234-1. FSIS program
employees would review FSIS Form 7234-1 to ensure that information on
the labels complies with the regulations. FSIS estimates that it would
take 60 minutes to design and develop modified product labels in
accordance with the proposed regulation and 15 minutes to prepare FSIS
Form 7234-1 and submit it, along with the label, to FSIS or to a label
expediter who would deliver the form and label to FSIS.
Respondents: Meat establishments.
Estimated Number of Respondents: 315 meat establishments.
Estimated Number of Responses per Respondent: FSIS estimates that
each
[[Page 12119]]
establishment would modify about 2 product labels.
Estimated Total Annual Burden on Respondents: 788 hours.
Copies of this information collection assessment can be obtained
from Lee Puricelli, Paperwork Specialist, Food Safety and Inspection
Service, USDA, Room 3812, South Agriculture Building, Washington, DC
20250-3700.
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; (d) ways to
minimize the burden of the 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. Send comments to both Lee Puricelli,
Paperwork Specialist, at the address provided above, and the Desk
Officer for Agriculture, Office of Information and Regulatory Affairs,
Office of Management and Budget, Washington, DC 20253.
Comments are requested by May 13, 1997. To be most effective,
comments should be sent to OMB within 30 days of the publication date
of this proposed rule.
List of Subjects in 9 CFR Part 318
Food additives, Meat inspection.
For the reasons discussed in the preamble, FSIS is proposing to
amend 9 CFR part 318 of the Federal meat inspection regulations as
follows:
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND
PREPARATION OF PRODUCTS
1. The authority citation for part 318 would be revised 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.
2. Section 318.7(c)(4) would be amended by adding to the chart of
substances, under the Class of Substance ``Flavoring agents; protectors
and developers,'' the substance sorbitol as follows:
Sec. 318.7 Approval of substances for use in the preparation of
products.
* * * * *
(c) * * *
(4) * * *
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Class of substance Substance Purpose Products Amount
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* * * * * *
*
Flavoring agents; Sorbitol....... To flavor, to As provided in part Not to exceed 2
protectors and facilitate the 319 of this percent of the weight
developers. removal of casings subchapter, cooked of the formula,
from product, and to roast beef, cured excluding the formula
reduce caramelization pork products, and weight of water or
and charring. cooked sausage ice, when used in
labeled frankfurter, accord-ance with 21
frank, furter, CFR 184.1835.
wiener, and
knockwurst.
* * * * * *
*
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Done at Washington, DC, on March 7, 1997.
Thomas J. Billy,
Administrator.
[FR Doc. 97-6447 Filed 3-13-97; 8:45 am]
BILLING CODE 3410-DM-P
