Docket No. FSIS-2011-0018

[Federal Register Volume 77, Number 88 (Monday, May 7, 2012)]
[Proposed Rules]
[Pages 26706-26709]
From the Federal Register Online via the Government Printing Office
[FR Doc No: 2012-10871]

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Proposed Rules
Federal Register
________________________________________________________________________

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. 77, No. 88 / Monday, May 7, 2012 / Proposed
Rules

[[Page 26706]]

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 424

[Docket No. FSIS-2011-0018]
RIN 0583-AD47

Food Ingredients and Sources of Radiation Listed and Approved for
Use in the Production of Meat and Poultry 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
remove sodium benzoate, sodium propionate, and benzoic acid from the
list of substances that the regulations prohibit for use in meat or
poultry products. Under this proposal, new uses of these substances in
meat or poultry products would continue to be approved by the Food and
Drug Administration (FDA) for safety and by FSIS for suitability. FSIS
would add approved uses of these substances to the list of approved
substances contained in the Agency's directive system.

DATES: Comments must be received by July 6, 2012.

ADDRESSES: FSIS invites interested persons to submit relevant comments
on this proposed rule. Comments may be submitted by either of the
following methods:
Federal eRulemaking Portal: This Web site provides the
ability to type short comments directly into the comment field on this
Web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the online instructions at that site for
submitting comments.
Mail, including floppy disks or CD-ROMs, and hand- or
courier-delivered items: Send to Docket Clerk, U.S. Department of
Agriculture (USDA), FSIS, OPPD, Patriots Plaza 3, 1400 Independence
Avenue SW., Mailstop 3782, 8-163A, Washington, DC 20250-3700.
Instructions: All items submitted by mail or electronic mail must
include the Agency name and docket number FSIS-2011-0018. Comments
received in response to this docket will be made available for public
inspection and posted without change, including any personal
information, to http://www.regulations.gov.
Docket: For access to background documents or comments received, go
to the FSIS Docket Room at the address listed above between 8 a.m. and
4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Charles Williams, Acting Director,
Policy Issuances Division, Office of Policy and Program Development,
FSIS, U.S. Department of Agriculture, 1400 Independence Avenue SW.,
Washington, DC 20250-3700, (202) 690-2282.

SUPPLEMENTARY INFORMATION:

Background

Under the Federal Food Drug and Cosmetics Act (FFDCA), (21 U.S.C.
301 et seq.) FDA is responsible for determining the safety of
ingredients and sources of irradiation used in the production of meat
and poultry products, as well as prescribing safe conditions of use.
Under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601, et seq.)
and the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.),
FSIS is responsible for determining the suitability of FDA-approved
substances in meat and poultry products. Pursuant to a Memorandum of
Understanding (MOU) that was implemented in January 2000, FDA and FSIS
work together to evaluate petitions requesting the approval of new
substances, or new uses of previously approved substances, for use in
or on meat and poultry products. The MOU is available for viewing by
the public in the FSIS docket room and on the FSIS Web site at: http://www.fsis.usda.gov/Regulations_&_Policies/Labeling_FDA_MOU/index.asp. If an ingredient is approved for use in meat or poultry
products, FDA establishes the parameters of the approved use under its
regulatory system. FSIS also lists the substance in FSIS Directive
7120.1, ``Safe and Suitable Ingredients Used in the Production of Meat,
Poultry, and Egg Products,'' as part of a comprehensive listing of the
substances that have been reviewed and that have been accepted as safe
and suitable.

Prohibited Substances That May Conceal Damage or Inferiority--
Regulatory Requirements

The regulations that prescribe requirements for the use of food
ingredients and sources of radiation in meat and poultry products
prohibit for use in such products substances that conceal damage or
inferiority or that make the product appear better or of greater value
(9 CFR 424.23(a)). Under the regulations, certain antimicrobial
substances are prohibited for use in meat or poultry products because
these substances have the potential to conceal damage or inferiority
when used at certain levels (9 CFR 424.23(a)(3)). Among these
substances are potassium sorbate, propylparaben (propyl p-
hydroxybenzoate), calcium propionate, sodium propionate, benzoic acid,
and sodium benzoate. The regulations provide that these substances ``*
* * may be used in or on any product, only as provided in 9 CFR Chapter
III'' (9 CFR 424.23(a)(3)). Thus, while FSIS lists approved uses of
other substances in its directive system, the Agency must codify any
approved use of the substances listed in 9 CFR 424.23(a)(3) in the meat
or poultry products inspection regulations.

Waivers of Regulatory Requirements

The meat and poultry products inspection regulations provide for
the FSIS Administrator to ``* * * waive for limited periods any
provisions of the regulations * * * to permit * * * experimentation so
that new procedures, equipment, and/or processing techniques may be
tested to facilitate definite improvements'' (9 CFR 303.1(h) and
381.3(b)). Under the regulations, FSIS may only grant waivers from the
provisions in the regulations that are not in conflict with the
purposes or provisions of the FMIA or PPIA (9 CFR 303.1(h) and
381.3(b)).
FSIS decides whether to grant requests for waivers after
considering proposals and documentation submitted by establishments to
demonstrate that the use of a new technology is scientifically sound;
that it will facilitate definite improvements; and that issuing the
waiver will not conflict with the provisions of the FMIA or PPIA, i.e.,
the conditions of use will not

[[Page 26707]]

result in an adulterated product or product labeling that misleads
consumers.\1\ If FSIS determines that the information submitted by an
establishment supports the requested waiver, the Agency will waive the
relevant provisions in the regulation for a limited period of time to
allow the establishment to conduct an in-plant trial. The purpose of
the in-plant trial is to gather data on the effects of the use of the
new technology. FSIS reviews the data that are developed in the trial
to determine whether they show that the purpose of the waiver is being
met.
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\1\ For Agency New Technology waiver procedures, see http://www.fsis.usda.gov/Regulations_&_Policies/New_Technologies/index.asp.
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Petitions

On January 19, 2007, Kraft Foods Global, Inc. petitioned FSIS to
amend the Federal meat and poultry products inspection regulations to
permit the use of sodium benzoate and sodium propionate as acceptable
antimicrobial agents that may be used in combination with other
approved ingredients to inhibit the growth of Listeria monocytogens
(Lm) in ready-to-eat (RTE) meat and poultry products. Kraft requested
that FSIS permit the use of sodium benzoate in amounts of up to 0.1
percent (by weight of total product formulation) in combination with
approved antimicrobial agents. Kraft requested that FSIS permit the use
of sodium propionate in amounts up to 0.2 percent (by weight of total
formulation) in combination with approved antimicrobial agents and
adjuvants.
On July 26, 2010, Kemin Food Technologies petitioned FSIS to amend
the regulations to permit the use of liquid sodium propionate and
liquid sodium benzoate as acceptable antimicrobial agents in meat and
poultry products. Kemin requested that FSIS approve the use of liquid
sodium propionate to inhibit microbial growth in various meat and
poultry products in amounts of up to 0.5 percent by weight of total
product formulation. Kemin also requested that FSIS approve the use of
liquid sodium propionate and sodium benzoate to prohibit microbial
growth in various meat and poultry products in amounts of up to 0.4
percent by weight of total formulation, whereas liquid sodium benzoate
will not exceed 0.1 percent of product formulation.
After receiving each petition, FSIS conducted an initial evaluation
of the requested action to confirm that FDA had no objections to the
safety of sodium benzoate, sodium propionate, or benzoic acid at the
proposed levels of use. FSIS also considered each petition's supporting
data on the suitability of these substances for use in meat and poultry
products. From its initial evaluation of each petition, FSIS, in
consultation with FDA, concluded that the petitioners had established
the safety of sodium benzoate, sodium propionate, and benzoic acid at
the proposed levels of use but that the Agency needed additional data
to make a final suitability determination.
Therefore, in July 2007, FSIS issued a waiver to Kraft to conduct
trials in 59 of its establishments on the use of sodium benzoate and
sodium propionate, in combination with other ingredients, to control
the growth of Lm in RTE meat and poultry products. Additionally, from
September 2010 through March 2011, FSIS issued waivers to various meat
and poultry products processing establishments to conduct trials on the
use of antimicrobial agents containing liquid sodium propionate and
propionic acid supplied by Kemin for Lm control in RTE meat and poultry
products. FSIS granted the waivers to allow the companies to gather
additional data on the suitability of these substances to support an
amendment to the regulations.
As a condition of the waivers, both Kraft and Kemin were to track
issues regarding consumer acceptance of products containing the
substances at issue during the trial period and to identify any
situations that resulted in consumer concerns about the products. The
waivers also provided that both companies were to collect data to show
that normal spoilage indicators are not masked in products treated with
the substances, that nutrients are not adversely affected, and that
product appearance (e.g., color) did not change when compared with
untreated products. Another condition of the waivers was that the meat
and poultry products formulated with the subject ingredients have an
approved label that includes an accurate declaration of the ingredients
in the appropriate order of predominance.
While operating under the waivers, both companies gathered
sufficient data to support the use of sodium propionate, sodium
benzoate, and benzoic acid as antimicrobial agents in RTE meat and
poultry products. Accordingly, FSIS is initiating this rulemaking
proposing to remove these substances from the list of substances
prohibited for use in meat or poultry products. Should FSIS finalize
this proposed rule, the Agency will list approved uses of these
substances in FSIS Directive 7120.1. FSIS has extended the companies'
regulatory waivers for the use of these substances pending the
conclusion of this rulemaking.

Data on Suitability

To demonstrate that sodium benzoate, sodium propionate, and benzoic
acid are suitable for their intended use as antimicrobial agents in
meat and poultry products, Kraft submitted data collected from its in-
plant-trials and from scientific studies that show that these
substances do not conceal damage or inferiority or make products appear
better or of greater value than they are under the proposed conditions
of use.
Kraft submitted research findings to demonstrate that its proposed
use of sodium benzoate and sodium propionate is effective in
controlling the growth of Lm in RTE meat and poultry products. The
research took into account the unique composition of diverse products,
such as hot dogs, bologna, ham, and turkey breast. Kraft developed an
approach to predicting the effect of antimicrobial ingredients on Lm
growth and confirmed the findings with tests of different formulations.
Kraft assessed treated products for quality, analyzed the nutritional
composition of planned formulations, and considered the status of
sodium benzoate and sodium propionate as generally recognized as safe
(GRAS) substances under FDA requirements. Kraft's research demonstrated
that differences in product composition, especially moisture, can
influence antimicrobial activity and formulation needs. From its study,
Kraft determined that the following formulations for the antimicrobial
ingredients are effective in controlling the growth of Lm:
(1) A combination of 0.1 percent sodium benzoate and 0.1 percent
sodium diacetate in some lower moisture products such as hot dogs;
(2) A combination of 0.1 percent sodium benzoate, 0.15 percent
sodium diacetate, and 0.2 percent sodium propionate in high moisture
products such as ham; and
(3) A combination of 0.1 percent sodium benzoate, 0.15 percent
sodium diacetate, 0.2 percent sodium propionate, and 0.56 percent Lem-
O-Fos[supreg] in turkey.
In addition, Kraft submitted three studies to address concerns
about the potential use of the substances to conceal damage or mask
inferiority. First, Kraft assessed whether the proposed uses of sodium
benzoate and sodium propionate would affect normal indicators of
spoilage. The results of two shelf life studies on the spoilage issue
showed that there was very little

[[Page 26708]]

difference in spoilage characteristics among products formulated with
the antimicrobial treatments being evaluated and products formulated
without antimicrobials. Second, Kraft conducted a nutritional
composition test for moisture, protein, fat, ash, and sodium content.
Other than a reduction in ash and an increase in moisture as lactate
solids are replaced by water, the study found no differences in
nutritional composition between products treated with the substances
and untreated products. Finally, Kraft evaluated the efficacy and
spoilage characteristics of sodium benzoate and sodium propionate in
vacuum packaging or modified atmosphere packaging with nitrogen and
carbon dioxide and found that the type of packaging did not have a
technical effect on the efficacy and spoilage characteristics of sodium
benzoate and sodium propionate. Furthermore, Kraft conducted consumer
research to demonstrate that there is consumer acceptance, that normal
spoilage indicators were not masked, that nutrients were not adversely
affected, and that product appearance was not changed as compared to
untreated product. The Kraft petition and supporting material are
available for viewing by the public on the FSIS Web site at: http://www.fsis.usda.gov/PDF/Petition_Kraft.pdf.
In its petition, Kemin submitted data collected from in-house
trials and university research that demonstrate that its proposed
applications of <= 0.5 percent liquid sodium propionate alone or <= 0.4
percent for the liquid blend of sodium propionate with benzoate are
effective in controlling the growth of Lm in cured turkey and cooked
chicken breast. Kemin noted that a comparison of test results with
previous studies and predictive models suggests that moisture, pH,
NaCl, added nitrite, storage temperature, and perhaps meat type, are
significant factors in determining the efficacy of various
antimicrobials. The petition explained that validation of the most
effective use rates of any antimicrobial treatments will need to be
performed on a case-by-case basis to account for many variables that
can affect microbial growth and efficacy in specific RTE meat and
poultry products.
To show that its proposed uses of liquid sodium propionate alone or
in a blend with sodium benzoate do not conceal damage or inferiority
when used in meat or poultry products, Kemin conducted studies to
demonstrate that the use of these substances does not affect normal
spoilage indicators in RTE poultry products. The studies compared
products containing Kemin's antimicrobial treatments at use rates of
0.3, 0.4, and 0.5 percent sodium propionate alone, or 0.4 percent when
combined with sodium benzoate, with an untreated control or a product
containing the current industry standard lactate. The studies showed
that, although growth of spoilage microorganisms was significantly
different in products from replicate trials, the competitive microflora
did not appear to have been affected by Kemin's antimicrobial
substances, and normal spoilage indicators were not disguised. In
addition, Kemin submitted data to demonstrate that proposed uses of
liquid sodium propionate alone or in a blend with sodium benzoate do
not negatively affect color, texture and other sensory attributes,
nutritional profile, or consumer acceptance when used at rates of up to
0.5 percent alone or 0.4 percent with sodium benzoate.
The Kemin petition and supporting material are available for
viewing by the public on the FSIS Web site at http://www.fsis.usda.gov/PDF/Petition_Kemin.pdf.

Proposed Rule

FSIS has reviewed the data that Kraft and Kemin have submitted in
support of their petitions and has determined that sodium benzoate,
sodium propionate, and benzoic acid, under the conditions proposed in
the petitions, are both safe and suitable for use as antimicrobial
agents in certain RTE meat and poultry products. Therefore, FSIS is
proposing to amend 9 CFR 424.23(a)(3) to remove these substances from
the list of prohibited substances that may be used ``* * * in or on any
product, only as provided in 9 CFR Chapter III.''
If this proposed rule is finalized, use of these substances in or
on meat or poultry products will continue to be approved by FDA for
safety and by FSIS for suitability. FDA will continue to establish the
parameters of the approved use under its regulatory system, and FSIS
will list approved uses of these substances in the table of approved
substances in Directive 7120.1. The proposed amendment will make the
procedures for listing approved uses of sodium propionate, benzoic
acid, and sodium benzoate consistent with the procedures for listing
other safe and suitable substances. This proposed rule will also
expedite the listing of substances, such as sodium benzoate and sodium
propionate, which enhance food safety by controlling Lm in RTE
products.
FSIS is not proposing to remove potassium sorbate, propylparaben
(propyl p-hydroxybenzoate), and calcium propionate from the list of
prohibited substances in 9 CFR 424.23(a)(3) because the petitions did
not include data on the use of these substances in meat or poultry
products. Therefore, if this proposed rule is finalized, approved new
uses of potassium sorbate, propylparaben (propyl p-hydroxybenzoate),
and calcium propionate would continue to be listed through rulemaking.
FSIS requests comments and supporting data on whether the Agency should
remove any of these substances from 9 CFR 424.23(a)(3) and list their
approved new uses in FSIS Directive 7120.1.

Executive Order 12866, Executive Order 13563, and Regulatory
Flexibility Act

Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This proposed rule has been determined to be not
significant and therefore has not been reviewed by the Office of
Management and Budget (OMB) under EO 12866.
This proposed rule would eliminate the need for FSIS to conduct
rulemakings each time that the use of certain substances identified in
Sec. 424.23(a)(3), i.e., sodium propionate, sodium benzoate, and
benzoic acid, is found to be safe by FDA and suitable by FSIS for use
in the production of meat and poultry products at specified levels.
This proposed rule would benefit companies that want to use these
substances in the production of meat and poultry products by expediting
the approval process. It would also benefit consumers by expediting the
approved use of substances that enhance food safety by controlling the
growth of Lm in RTE meat and poultry products. This proposed rule would
make the approval process for new uses of sodium propionate, sodium
benzoate, and benzoic acid in meat and poultry products consistent with
the process for obtaining approval for other safe and suitable
substances.
There are no expected costs associated with this proposed rule. All
substances intended for use in the production of meat and poultry

[[Page 26709]]

products will continue to be subject to FDA evaluation for safety and
FSIS evaluation for suitability. Company costs and the agencies' costs
associated with these evaluations will not be affected by this proposed
rule should it become final. The only change would be the process for
listing the substances specified in this proposal after they have been
approved.

Regulatory Flexibility Act

Pursuant to section 605(b) of the Regulatory Flexibility Act, 5
U.S.C. 605(b), the FSIS Administrator has made a preliminary
determination that this proposed rule will not have a significant
impact on a substantial number of small entities. This determination is
based primarily on the fact that the proposed rule would not affect the
process for approving new uses of sodium benzoate, sodium propionate,
and benzoic acid in meat or poultry products. This proposed rule would
make the process of listing approved uses of these substances more
efficient by eliminating the need for FSIS to conduct rulemaking each
time a new use is approved.

Paperwork Reduction Act

This rule does not contain any new information collection or record
keeping requirements that are subject to the Office of Management and
Budget (OMB) approval under the Paperwork Reduction Act, 44 U.S.C.
3501, et seq.

E-Government Act

FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things,
promoting the use of the Internet and other information technologies
and providing increased opportunities for citizen access to Government
information and services, and for other purposes.

Executive Order 12988

This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This proposed rule: (1) Has no retroactive
effect; and (2) does not require administrative proceedings before
parties may file suit in court challenging this rule. However, the
administrative procedures specified in 9 CFR 306.5, 381.35, and 590.300
through 590.370, respectively, must be exhausted before any judicial
challenge may be made of the application of the provisions of the
proposed rule, if the challenge involves any decision of an FSIS
employee relating to inspection services provided under the FMIA, PPIA,
or EPIA.

Additional Public Notification

FSIS will announce the availability of this proposed rule on-line
through the FSIS Web page located at http://www.fsis.usda.gov/regulations_&_policies/Federal_Register_Proposed_Rules/index.asp.
FSIS also will make copies of this Federal Register publication
available through the FSIS Constituent Update, which is used to provide
information regarding FSIS policies, procedures, regulations, Federal
Register notices, FSIS public meetings, and other types of information
that could affect or would be of interest to our constituents and
stakeholders. The Update is communicated via Listserv, a free email
subscription service for industry, trade, and farm groups, consumer
interest groups, allied health professionals, scientific professionals,
and other individuals who have requested to be included. The Update
also is available on the FSIS Web page. Through Listserv and the Web
page, FSIS is able to provide information to a much broader, more
diverse audience.
In addition, FSIS offers an email subscription service which
provides automatic and customized access to selected food safety news
and information. This service is available at http://www.fsis.usda.gov/news_and_events/email_subscription/. Options range from recalls to
export information to regulations, directives, and notices. Customers
can add or delete subscriptions themselves, and have the option to
password-protect their accounts.

List of Subjects in 9 CFR Part 424

Food additives, Food packaging, Meat inspection, Poultry and
poultry products.

For the reasons set forth in the preamble, FSIS proposes to amend 9
CFR part 424 as follows:

PART 424--PREPARATION AND PROCESSING OPERATIONS

1. The authority citation for part 424 would continue to read as
follows:

Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 451-470, 601-695;
7 CFR 2.18, 2.53.

2. Revise Sec. 424.23(a)(3) as follows:

Sec. 424.23 Prohibited uses.

* * * * *
(a) * * *
(3) Sorbic acid, calcium sorbate, sodium sorbate, and other salts
of sorbic acid shall not be used in cooked sausages or any other meat;
sulfurous acid and salts of sulfurous acid shall not be used in or on
any meat; and niacin or nicotinamide shall not be used in or on fresh
meat product; except that potassium sorbate, propylparaben (propyl p-
hydroxybenzoate), and calcium propionate, may be used in or on any
product, only as provided in 9 CFR chapter III.
* * * * *

Done at Washington, DC, on May 1, 2012.
Alfred V. Almanza,
Administrator.
[FR Doc. 2012-10871 Filed 5-4-12; 8:45 am]
BILLING CODE 3410-DM-P