Docket No. FSIS-2011-0018

[Federal Register Volume 78, Number 45 (Thursday, March 7, 2013)]
[Rules and Regulations]
[Pages 14636-14640]
From the Federal Register Online via the Government Printing Office
[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]
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