[Federal Register Volume 78, Number 45 (Thursday, March 7, 2013)]
[Rules and Regulations]
[Pages 14636-14640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-05341]


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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: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the 
Federal meat and poultry products inspection regulations 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. New uses of these substances in meat or poultry products will 
continue to be approved by the Food and Drug Administration (FDA) for 
safety and by FSIS for suitability. FSIS will add approved uses of 
these substances to the list of approved substances contained in the 
Agency's directive system.

DATES: Effective May 6, 2013.

FOR FURTHER INFORMATION CONTACT: Charles Williams, 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) 720-5627.

SUPPLEMENTARY INFORMATION: 

Background

    On May 7, 2012, FSIS issued a proposed rule entitled ``Food 
Ingredients and Sources of Radiation Listed and Approved for Use in the 
Production of Meat and Poultry Products'' and requested comments on the 
document (77 FR 26706). FSIS proposed 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.
    As explained in the proposal, 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. Under this MOU, if FDA and FSIS 
approve an ingredient 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. (The Directive is available at: http://www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/7120.1.pdf.)
    The proposed rule also explained that, under FSIS's 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 
phydroxybenzoate), calcium propionate, sodium propionate, benzoic acid, 
and sodium benzoate.
    In 2006, 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 monocytogenes 
(Lm) in ready-to-eat (RTE) meat and poultry products. 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.

[[Page 14637]]

    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 petitioner's 
supporting data on the suitability of these substances for use in meat 
and poultry products. FSIS 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 of provisions under 9 CFR 303.1(h) 
and 381.3(b) to enable Kraft to conduct various experimental trials 
involving 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 Kemin and to various meat and 
poultry product 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 an poultry 
products.
    While operating under the waivers, the Kemin and Kraft 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. 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. Kemin also submitted 
findings supporting the use of its sodium propionate and propionic acid 
formulations.
    The Kemin petition and supporting materials are available for 
viewing by the public on the FSIS Web site at http://www.fsis.usda.gov/PDF/Petition_Kemin.pdf. The Kraft petition is available at: http://www.fsis.usda.gov/PDF/Petition_Kraft.pdf.

Final Rule

    After considering the comments received and discussed below, FSIS 
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 amending 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.''
    Under this final rule, 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. In that directive, FSIS will specify that sodium 
propionate (generally recognized as safe under 21 CFR 184.1784) can be 
used as an antimicrobial in various meat and poultry products in an 
amount not to exceed 0.5 percent (by weight of total formulation) when 
used alone. Sodium propionate is a direct food ingredient that must be 
labeled by its common or usual name in the ingredients statement of a 
product (21 CFR 101.4, 9 CFR 317.2(f), 381.118(a)).
    The directive also will state that, when used as an antimicrobial, 
sodium benzoate can be used in various meat and poultry products at up 
to 0.1 percent when used alone (21 CFR 184.1733). Sodium benzoate is a 
direct food additive that must be labeled by its common or usual name 
in the ingredients statement of a product. Similarly, benzoic acid is a 
generally recognized as safe (GRAS) direct food ingredient that can be 
used in various meat and poultry products at up to 0.1 percent (21 
184.1021 and similarly must be labeled (21 CFR 101.4, 9 CFR 317.2(f) 
and 381.118(a)).
    The uses of these substances are consistent with FDA regulations 
and reflect the levels that the petitioners requested to use in meat 
and poultry products and that they provided supporting data. Also, the 
use of these substances enhances food safety by controlling Lm in RTE 
products.
    The Kraft petition also addressed sodium diacetate (GRAS under 21 
CFR 184.1754 when used as an antimicrobial agent under cGMP). The 
company intends to use this substance in combination with sodium 
benzoate and sodium propionate. Sodium diacetate is not one of the 
substances considered in this rulemaking because is not prohibited by 
FSIS regulations. When sodium benzoate, sodium propionate, or sodium 
diacetate are used in combination with each other, the overall maximum 
level for the combination cannot exceed 0.1 percent (in accordance with 
21 CFR 184.1(d)). FSIS will include this information in the directive.
    As a result of amending 9 CFR 424.23(a)(3), the procedures for 
listing approved uses of sodium propionate, benzoic acid, and sodium 
benzoate in the FSIS directive will be consistent with the procedures 
for listing approved uses in meat and poultry products of other safe 
and suitable substances. Approved new uses of potassium sorbate, 
propylparaben (propyl p-hydroxybenzoate), and calcium propionate will 
continue to be listed through rulemaking because the regulations (9 CFR 
424.23(a)(3)) prohibit their use in meat and poultry products.
    FSIS carefully considered all the comments received and developed 
the following responses.

Discussion of Comments

    FSIS received 20 comments in response to the proposed rule. Members 
of the public submitted twelve, organizations related to the food 
industry five, and a food safety consulting firm, a non-profit 
association, and a trade association each submitted one. Several 
commenters supported the proposal 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. They stated 
that the additives are effective as anti-Listerial agents and are 
suitable for specified uses in meat and poultry products.
    FSIS agrees that adding sodium propionate to the list of approved 
ingredients also provides meat and poultry processors greater 
flexibility in formulating new products while protecting the food 
supply against Listeria. Moreover, sodium propionate and propionic 
acid, which are GRAS (21 CFR 170.30, 21 CFR 184.1784) for use as 
antimicrobials under current good manufacturing practices, have been 
confirmed as safe and effective at inhibiting Lm. Sodium propionate 
does not mask spoilage or negatively affect sensory attributes. This 
ingredient provides the benefit of lowering sodium contribution in meat 
and poultry products, while extending shelf-life.
    The following is a discussion of the relevant issues raised in the 
comments.
    Comment: A commenter asked why there were no tests involving the 
human body after eating the substances. Another commenter expressed 
concern about the cumulative effects of combined dosages of sodium 
benzoate,

[[Page 14638]]

sodium propionate, and benzoic acid on children.
    Response: FSIS and FDA do not conduct tests of the effects of food 
ingredients directly on humans. For a GRAS substance, such as the 
substances discussed in this rule, generally available data and 
information about the use of the substance are known and widely 
accepted and FDA has a basis for concluding that there is consensus 
among qualified experts that the data and information establish that 
the substance is safe under the conditions of its intended use (21 CFR 
170.36(c)(4)(i)(C)). For a food additive, privately held data and 
information about the use of the substance are sent by the sponsor to 
FDA. FDA then evaluates the data and information to determine whether 
they establish that the substance is safe under the conditions of its 
intended use (21 CFR 171.1).
    FSIS and FDA have evaluated all the data and determined that the 
uses of these substances considered in this rule are safe for 
individual consumers, including children.
    Comment: A few commenters disapproved removing sodium benzoate, 
sodium propionate, and benzoic acid from the list of substances 
prohibited from use in meat and poultry products because they stated 
that these ingredients would have harmful effects on human health. One 
commenter explained that, as a potential consumer of harmful additives, 
she found the evidence submitted by Kraft Foods and Kemin Food 
Technologies insufficient to prove that all three agents are safe for 
use in meat and poultry products. Specifically, the commenter stated 
that Kemin had relied on old research (a 1973 study conducted by the 
Select Committee on Generally Recognized as Safe Substances) to prove 
the safe use of sodium benzoate and benzoic acid and that new research 
must be performed to ensure the safety of benzoic acid for public use.
    Another commenter expressed concern because Kraft stated that it 
used Lem-O-Fos in its meat and poultry products to ``enhance 
antimicrobial activity.'' The commenter stated that studies have shown 
that when benzoic acid is mixed with citric acid it forms benzene, 
which is a carcinogen. In the commenter's opinion, the substances 
should be kept separate from one another or concrete evidence must 
prove that the mixture does not constitute a hazard to consumers.
    Another commenter stated that, in the early 1990s, the FDA urged 
companies not to use benzoate in products that also contain ascorbic 
acid. The commenter noted that a lawsuit filed in 2006 by private 
attorneys ultimately forced Coca-Cola, PepsiCo, and other soft-drink 
makers in the United States to reformulate affected beverages--
typically fruit-flavored products. According to this commenter, soft-
drink makers are now eliminating the use of benzoate in combination 
with vitamin C worldwide. This commenter stated that these developments 
should cause FDA and FSIS to reconsider whether benzoate should 
continue to be classified as GRAS. Another stated that the GRAS status 
of the sodium benzoate should be reviewed to take into account changes 
in consumer diets and advances in science and technology. The commenter 
also stated that FSIS should not expand its use until a safety 
assessment is done and noted that the European Union is in the process 
of reviewing its safety now.
    Response: FDA and FSIS have considered the points made by the 
commenters and have determined that there are no human health hazards 
arising from the approved uses that will be listed in FSIS Directive 
7120.1.
    The conditions under which benzene is produced in soft drinks are 
different from the conditions under which benzene could be produced in 
ready-to-eat (RTE) meats. RTE meats have a pH close to neutral, are 
continuously refrigerated or stored at room temperature (canned RTE 
meats), and are protected from excessive exposure to light. Therefore, 
the use of sodium benzoate in RTE meats does not present a safety 
concern even if combined with Vitamin C or similar compounds.
    Regarding the concern that the GRAS status of sodium benzoate 
should be reviewed, FDA has confirmed that the petitioner's intended 
use of sodium benzoate is covered under the GRAS regulations (at 21 CFR 
184.1733) and that there are no safety issues with the intended use. 
FSIS accepts the conclusion of FDA. Further, FSIS is aware that the 
Codex Committee on Food Additives (1995)\1\ has also approved the use 
of benzoates in cured (including salted) and dried non-heat treated 
processed (including comminuted) meat and poultry products, at a 
maximum level of 0.1 percent.
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    \1\ Codex Alimentarius Committee on Food Additives. 1995. Codex 
General Standard for Food Additive, Codex Stan 192, pg 80. Available 
at: http://www.codexalimentarius.org/committees-and-task-forces/en/?provide=committeeDetail&idList=9. Accessed November 9, 2012.
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    Regarding the European Union's evaluation, the European Food Safety 
Authority (EFSA) issued a data call June 1, 2012, on the occurrence in 
foods and beverages of certain food additives (sorbates, benzoates, and 
gallates) that were already permitted in the EU before January 20, 
2009. Benzoic acid and sodium benzoate are among the ingredients on the 
list. The data are to be used to re-evaluate the ingredients. We 
understand from EFSA that the report on this re-evaluation will be 
available in late Spring 2013. When the re-evaluation is completed, 
experts in this Agency, and particularly in FDA, will consider the 
results and their possible implications. At this time, however, the 
available evidence supports the safety of the use of these ingredients.
    Comment: One commenter supported the proposed rule but suggested 
that more studies be conducted on the effects of these three 
preservatives in higher dosages (higher than the use levels currently 
permitted under the FDA GRAS regulations), possible allergic reactions 
through contact or ingestion and the extent of those reactions, and 
potential alternatives to these preservatives that produce the same 
outcome without the use of preservatives.
    Response: The levels that FSIS would allow to be used under this 
rule have not been shown to cause allergic reactions. Data on uses at 
higher levels would be evaluated under the joint FDA and FSIS 
ingredient approval system.
    Data in the scientific literature on the amounts of these 
substances that are necessary to trigger or give rise to allergic 
reactions are not available. Food additives, such as benzoic acid and 
benzoates, have been known to cause hypersensitivity reactions. Such 
reactions are known to be very unusual in healthy individuals. However, 
in some cases, doses as low as 50 mg of benzoates have been shown to 
cause allergic reactions in individuals already suffering from allergic 
reactions. Information on the effects of these doses on healthy 
individuals is not currently available. Therefore, it is important that 
food additives or ingredients that may cause severe allergic or 
hypersensitivity reactions be appropriately declared in the ingredient 
statement on the product label.
    Industry is likely to pursue research on the preservatives that are 
the subject of this rulemaking and on others. FSIS and FDA will 
continue to review new substances for safety and suitability under the 
MOU.
    Comment: A commenter recommended not specifying a pH range of 4.8 
to 5.2 percent for the use of sodium propionate as indicated in the 
Kemin petition, increasing the permissible use level of propionate

[[Page 14639]]

when used in combination with other antimicrobial ingredients, and 
specifying that the substances are to be used in meat and poultry, 
including RTE products. The commenter explained that a higher pH 
provides several benefits including greater stability of the 
antimicrobial solution, better handling and shipping classifications, 
and improved sensory characteristics in finished meat products.
    The commenter further stated that not including a pH specification 
in the approved ingredient listing in the FSIS Directive will provide 
room for innovation and fair competition in the market. Moreover, a 
permitted use level of sodium propionate in RTE meat and poultry 
products is necessary because the firm's testing results indicate that 
propionate, when combined with commonly used existing antimicrobials 
for meat and poultry (e.g., lactate, acetate, and diacetate), is 
required at higher levels to ensure safety of uncured high-moisture 
items.
    Response: As noted above, sodium propionate that meets food grade 
standards as outlined in the Food Chemicals Codex, when used in 
accordance with 21 CFR 184.1784, is GRAS for use as an antimicrobial 
agent in meat products with no other limitations than cGMP. Therefore, 
FSIS will not specify a pH level in its Directive 7120.1. Also, since 
21 CFR 184.1784 does not prescribe a maximum use level for sodium 
propionate, when the substance is used in combination with another 
antimicrobial agent, the maximum level for the combination is governed 
by the maximum use level of the other antimicrobial. For example, when 
sodium propionate is used in combination with sodium benzoate, the 
maximum level for the mixture is not to exceed 0.1 percent. When sodium 
propionate is used in combination with sodium diacetate, the maximum 
use level for the mixture is not to exceed 0.25 percent.
    The directive will specify the uses of benzoic acid, sodium 
benzoate, and sodium propionate in meat and poultry products, including 
RTE meat and poultry products.

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 final rule has been determined not to be significant 
and therefore has not been reviewed by the Office of Management and 
Budget (OMB) under E.O. 12866.
    The rule will benefit companies that want to use these substances 
in the production of meat and poultry products by expediting the 
approval process. It will 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. The rule also will 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 final rule. All 
substances intended for use in the production of meat and poultry 
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 final 
rule.

Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act, 5 
U.S.C. 605(b), the FSIS Administrator has determined that this final 
rule will not have a significant impact on a substantial number of 
small entities. This determination is based primarily on the fact that 
the final rule will not affect the process for approving new uses of 
sodium benzoate, sodium propionate, and benzoic acid in meat or poultry 
products. This final rule will 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.

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This 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 final rule, if 
the challenge involves any decision of an FSIS employee relating to 
inspection services provided under the FMIA, PPIA, or EPIA.

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.

Additional Public Notification

    FSIS will announce the availability of this final rule on-line 
through the FSIS Web page located at http://www.fsis.usda.gov/regulations_&_policies/Interim_&_Final_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.

[[Page 14640]]

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 is amending 9 CFR 
part 424 as follows:

PART 424--PREPARATION AND PROCESSING OPERATIONS

0
1. The authority citation for part 424 continues 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.

0
2. In Sec.  424.23, revise paragraph (a)(3) to read 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: February 28, 2013.
Alfred V. Almanza,
Administrator.
[FR Doc. 2013-05341 Filed 3-6-13; 8:45 am]
BILLING CODE 3410-DM-P