[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]


========================================================================
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.

========================================================================


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.

-----------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \1\ For Agency New Technology waiver procedures, see http://www.fsis.usda.gov/Regulations_&_Policies/New_Technologies/index.asp.
---------------------------------------------------------------------------

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