Food Additive Regulations; Incorporation by Reference of the Food Chemicals Codex, 7th Edition, 71457-71467 [2013-28439]
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Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Rules and Regulations
that there is specific, objective support
for the burden estimates associated with
the information requirements.
62. Interested persons may obtain
information on the reporting
requirements by contacting the Federal
Energy Regulatory Commission, Office
of the Executive Director, 888 First
Street NE., Washington, DC 20426
[Attention: Ellen Brown, email: Data
Clearance@ferc.gov, phone: (202) 502–
8663, fax: (202) 273–0873].
IV. Environmental Analysis
63. The Commission is required to
prepare an Environmental Assessment
or an Environmental Impact Statement
for any action that may have a
significant adverse effect on the human
environment.54 The Commission has
categorically excluded certain actions
from this requirement as not having a
significant effect on the human
environment. Included in the exclusion
are rules that are clarifying, corrective,
or procedural or that do not
substantially change the effect of the
regulations being amended.55 The
actions directed herein fall within this
categorical exclusion in the
Commission’s regulations.
V. Regulatory Flexibility Act
64. The Regulatory Flexibility Act of
1980 (RFA) 56 generally requires a
description and analysis of proposed
rules that will have significant
economic impact on a substantial
number of small entities. As discussed
above, regional Reliability Standard
BAL–002–WECC–2 applies to 36
registered balancing authorities and
reserve sharing groups in the NERC
Compliance Registry. Comparison of the
NERC Compliance Registry with data
submitted to the Energy Information
Administration on Form EIA–861
indicates that, of the 36 registered
balancing authorities and reserve
sharing groups, two may qualify as
small entities.57
65. The Commission estimates that,
on average, each of the two affected
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54 Regulations
Implementing the National
Environmental Policy Act of 1969, Order No. 486,
52 FR 47897 (Dec. 17, 1987), FERC Stats. & Regs.,
Regulations Preambles 1986–1990 ¶ 30,783 (1987).
55 18 CFR 380.4(a)(2)(ii).
56 5 U.S.C. 601–612.
57 The RFA definition of ‘‘small entity’’ refers to
the definition provided in the Small Business Act
(SBA), which defines a ‘‘small business concern’’ as
a business that is independently owned and
operated and that is not dominant in its field of
operation. See 15 U.S.C. 632. According to the
Small Business Administration, an electric utility is
defined as ‘‘small’’ if, including its affiliates, it is
primarily engaged in the generation, transmission,
and/or distribution of electric energy for sale and
its total electric output for the preceding fiscal year
did not exceed 4 million megawatt hours.
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small entities will have an estimated
cost of $60 in Year 1 and no further
ongoing costs. These figures are based
on information collection costs plus
additional costs for compliance. The
Commission does not consider this to be
a significant economic impact for small
entities because it should not represent
a significant percentage of the small
entities’ operating budgets. The
Commission solicited comments
concerning is proposed Regulatory
Flexibility Act certification and did not
receive any comments. Accordingly, the
Commission certifies that this Final
Rule will not have a significant
economic impact on a substantial
number of small entities.
By the Commission.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
VI. Document Availability
AGENCY:
66. In addition to publishing the full
text of this document in the Federal
Register, the Commission provides all
interested persons an opportunity to
view and/or print the contents of this
document via the Internet through the
Commission’s Home Page (https://
www.ferc.gov) and in the Commission’s
Public Reference Room during normal
business hours (8:30 a.m. to 5:00 p.m.
Eastern time) at 888 First Street NE.,
Room 2A, Washington, DC 20426.
67. From the Commission’s Home
Page on the Internet, this information is
available on eLibrary. The full text of
this document is available on eLibrary
in PDF and Microsoft Word format for
viewing, printing, and/or downloading.
To access this document in eLibrary,
type the docket number excluding the
last three digits of this document in the
docket number field.
68. User assistance is available for
eLibrary and the Commission’s Web site
during normal business hours from the
Commission’s Online Support at (202)
502–6652 (toll free at 1–866–208–3676)
or email at ferconlinesupport@ferc.gov,
or the Public Reference Room at (202)
502–8371, TTY (202) 502–8659. Email
the Public Reference Room at
public.referenceroom@ferc.gov.
ACTION:
71457
69. These regulations are effective
January 28, 2014. The Commission has
determined, with the concurrence of the
Administrator of the Office of
Information and Regulatory Affairs of
OMB, that this rule is not a ‘‘major rule’’
as defined in section 351 of the Small
Business Regulatory Enforcement
Fairness Act of 1996.
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BILLING CODE 6717–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 172, 173, 178, and 180
[Docket No. FDA–2010–F–0320]
Food Additive Regulations;
Incorporation by Reference of the
Food Chemicals Codex, 7th Edition
Food and Drug Administration,
HHS.
VII. Effective Date and Congressional
Notification
PO 00000
[FR Doc. 2013–28626 Filed 11–27–13; 8:45 am]
Final rule.
The Food and Drug
Administration (FDA or we) is
amending select food additive
regulations that incorporate by reference
food-grade specifications from prior
editions of the Food Chemicals Codex
(FCC) to incorporate by reference foodgrade specifications from the FCC 7th
Edition (FCC 7). We are taking this
action in response to a petition filed by
the United States Pharmacopeial
Convention (U.S.P. or petitioner).
DATES: This rule is effective November
29, 2013. See the ‘‘Objections’’ heading
of the SUPPLEMENTARY INFORMATION
section for information on the filing of
objections. Submit either electronic or
written objections and requests for a
hearing by December 30, 2013. The
Director of the Office of the Federal
Register approves the incorporation by
reference of certain publications listed
in the rule as of November 29, 2013.
ADDRESSES: You may submit either
electronic or written objections and
requests for a hearing, identified by
Docket No. FDA–2010–F–0320, by any
of the following methods:
SUMMARY:
Electronic Submissions
Submit electronic objections in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written objections in the
following ways:
• Mail/Hand delivery/Courier (for
paper or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
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Instructions: All submissions received
must include the Agency name and
Docket No. FDA–2010–F–0320 for this
rulemaking. All objections received may
be posted without change to https://
www.regulations.gov, including any
personal information provided. For
detailed instructions on submitting
objections, see the ‘‘Objections’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
objections received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Mical Honigfort, Center for Food Safety
and Applied Nutrition (HFS–265), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740–
3835, 240–402–1278.
SUPPLEMENTARY INFORMATION:
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I. Background
In a notice published in the Federal
Register of August 10, 2010 (75 FR
48353), we announced that the U.S.P.,
12601 Twinbrook Pkwy., Rockville, MD
20852, had filed a food additive
petition. The petition proposed that
select food additive regulations in parts
172, 173, 178, and 180 (21 CFR parts
172, 173, 178, and 180), which
incorporate by reference food-grade
specifications from prior editions of the
FCC, be amended to incorporate by
reference food-grade specifications from
FCC 7.
The FCC is a compendium of
specification monographs for substances
used as food ingredients. The
Committee on Food Chemicals Codex of
the Food and Nutrition Board, Institute
of Medicine (IOM) of the National
Academies published the first through
fifth editions of the FCC. In 2006, U.S.P.
acquired the rights to the FCC, and
subsequently published the sixth,
seventh, and eighth editions.
Specifications and methods published
in the FCC have been incorporated by
reference in various sections of 21 CFR
parts 73, 170, 172, 173, 178, 180, and
184.
Since acquiring rights to the FCC,
U.S.P. has developed and continues to
develop standards for food ingredients
through public participation with a goal
of biennial publication of the FCC. Draft
monographs and data are provided by
food ingredient manufacturers, users,
and suppliers and are published for
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public review and comment on U.S.P.’s
Web site. U.S.P. scientists and its Food
Ingredients Expert Committee review
these data and, if necessary, conduct
laboratory tests. Once approved by the
Food Ingredients Expert Committee,
new or updated monographs are
published in the next edition or
Supplement to the FCC.
The petitioner initially requested
amendments to 39 existing references to
older editions of the FCC in parts 172,
173, 178, and 180 to incorporate by
reference the specifications contained in
FCC 7. The petitioner explained that of
the regulations it has requested to be
updated, 15 regulations refer to the third
edition of the FCC (FCC III, published
in 1981); 18 regulations refer to the
fourth edition of the FCC (FCC IV,
published in 1996); 4 regulations refer
to the fifth edition of the FCC (FCC V,
published in 2004); and 2 regulations
refer to the sixth edition of the FCC
(FCC 6, published in 2008). (The IOM
used roman numerals when referring to
editions of the FCC, e.g., FCC III and
FCC V. U.S.P. uses numbers rather than
roman numerals to refer to the editions
of FCC that it has published, e.g., FCC
6 and FCC 7.) In most cases, the
references to the FCC in the regulations
are to an entire FCC monograph. Some
references, however, only refer to part of
an FCC monograph, i.e., a single
specification, or to an FCC analytical
method.
After discussions with us in July
2011, the petitioner subsequently
narrowed its petition to exclude six
regulations ((§§ 172.172.723(b)(3),
172.833(b)(4), 172.846(b), 172.858(a),
180.25(b), and 180.30(a)). The current
regulation for epoxidized soybean oil
(§ 172.723(b)(3)) includes a limit of 10
milligrams per kilogram (mg/kg) for
heavy metals (as lead (Pb)), as
determined by Method II of the ‘‘Heavy
Metals Test’’ in FCC IV. FCC 7,
however, does not include a monograph
for epoxidized soybean oil and does not
include the ‘‘Heavy Metals Test’’ as a
general test in the appendices of FCC 7.
Accordingly, § 172.723(b)(3) has been
excluded from the petition. U.S.P. has
excluded the remaining five regulations
(§§ 172.833(b)(4), 172.846(b), 172.858(a),
180.25(b), and 180.30(a)) based on its
need to further investigate the bases for
such updates.
The petitioner cited several reasons
for updating the references to older
editions of the FCC to specifications and
analytical methodologies contained in
FCC 7. First, previous editions of the
FCC are no longer readily available to
industry or the public, since U.S.P. does
not maintain and therefore cannot
provide copies of monographs from FCC
PO 00000
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III, IV, or V to industry or the public.
(Under 5 U.S.C. 552(a) and 1 CFR
51.7(a)(4), a publication that is to be
incorporated by reference must be
‘‘reasonably available’’ to and capable of
being used by persons affected by the
publication.) Second, the petitioner
maintained that updating the references
to older editions of the FCC to FCC 7
may avoid confusion, inconsistency,
and lack of uniformity in the quality of
food additives and ingredients
manufactured and sold. Third, the
petitioner noted that, in many cases, the
editions of the FCC prior to FCC 7 may
employ outdated analytical
methodologies and equipment that do
not reflect current scientific practices,
and which may be difficult to obtain.
We note that, subsequent to our
analysis of FCC 7, the U.S.P. published
the eighth edition of the FCC (FCC 8) in
March 2012. Initiating a review of FCC
8 at this time would delay issuance of
this final rule. To avoid a delay in
updating the references to the FCC in
our food additive regulations, we are
proceeding with issuing this final rule
to incorporate by reference FCC 7. The
specific food additive regulations
explain how to obtain copies of FCC 7.
As appropriate, we will provide further
updates to our food additive regulations
to reflect more recent versions of the
FCC.
II. Evaluation of Amendments to Parts
172, 173, 178, and 180
We compared the specifications and
analytical methods in the versions of the
FCC currently referenced in the
regulations to the specifications and
analytical methods in FCC 7 (Ref. 1). In
addition, we note that some general
changes were made to FCC monographs
published in or after FCC IV that remain
in FCC 7. One change is that the older
FCC monographs discussed in this
document that contain a specification
limit for heavy metals (as Pb) were
updated in FCC V to remove this
specification, and, when appropriate, to
replace it with an individual
specification limit for each relevant
heavy metal. Many FCC 7 monographs
have also adopted lower lead limit
specifications compared to earlier FCC
editions, to reduce lead in food.
Furthermore, if an earlier edition of the
FCC contained a specification limit for
arsenic, that specification has been
removed unless the monograph met one
of the following criteria: (1) The
ingredient or additive is a high-volume
consumption item (greater than 25
million pounds per year), (2) the
ingredient or additive is derived from a
natural (mineral) source where arsenic
may be an intrinsic contaminant, and/or
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(3) there is reason to believe that arsenic
constitutes a significant part of the total
heavy metals content (Ref. 1).
An FCC monograph typically consists
of a description of the substance, its
functional use, the recommended
specifications for the substance, and
testing methodology. In many cases,
there are minor differences between the
description or functional use of a
substance provided in FCC 7 compared
to the description or functional use of a
substance provided in earlier editions of
the FCC and the CFR. However, FCC 7
provides the description and functional
use of a substance specified in a
monograph for informational purposes,
e.g., to help industry understand the
possible functions of the ingredients,
rather than as a required standard. Other
differences (e.g., solvent or instrument
changes) between the specifications and
analytical methods in the version of the
FCC currently referenced in the
regulations and the specifications and
analytical methods in FCC 7 are
discussed further in the FDA
Memoranda from D. Folmer to M.
Honigfort (Refs. 1 through 3).
After review of each proposed
amendment, we are updating the
regulations shown in table 1 to
incorporate FCC 7 by reference. We note
that the safety of these additives has
been previously considered and there
are no safety concerns with the
proposed changes to incorporate by
reference the specifications and
71459
analytical methodologies contained in
FCC 7. We are also amending § 178.1005
to incorporate by reference the
specifications for ‘‘Acidity,’’ ‘‘Chloride’’
and ‘‘Other requirements’’ for Hydrogen
Peroxide Concentrate in the United
States Pharmacopeia, 36th Revision
(2013). This updates the reference to the
United States Pharmacopeia XX (1980)
already cited in § 178.1005. We
compared the United States
Pharmacopeia XX (1980) monograph for
Hydrogen Peroxide Concentrate to the
United States Pharmacopeia, 36th
Revision (2013) monograph for
Hydrogen Peroxide Concentrate and
determined that this update is safe and
appropriate (Ref. 4).
TABLE 1—LIST OF REGULATIONS
Name of Additive
FCC 7 Reference
172.167(b) .........................
172.320(b)(1) .....................
172.345(b) .........................
172.379(b) .........................
172.380(b) .........................
172.665(d)(2) .....................
Hydrogen peroxide .........................................
Amino acids ....................................................
Folic acid (folacin) ..........................................
Vitamin D2 ......................................................
Vitamin D3 ......................................................
Gellan gum .....................................................
172.712(b) .........................
172.736(b)(2) .....................
1,3-Butylene glycol .........................................
Glycerides and polyglycides of hydrogenated
vegetable oils.
172.780(b) .........................
172.800(b)(2) .....................
Acacia (gum arabic) .......................................
Acesulfame potassium ...................................
172.804(b) .........................
172.810 ..............................
172.812(a) .........................
172.831(b) .........................
172.841(b) .........................
172.862(b)(1) .....................
Aspartame ......................................................
Dioctyl sodium sulfosuccinate ........................
Glycine ...........................................................
Sucralose .......................................................
Polydextrose ...................................................
Oleic acid derived from tall oil fatty acids ......
172.867(b) .........................
172.869(b)(6) .....................
Olestra ............................................................
Sucrose oligoesters ........................................
172.869(b)(7) .....................
Sucrose oligoesters ........................................
172.869(b)(8) .....................
Sucrose oligoesters ........................................
172.869(b)(9) .....................
Sucrose oligoesters ........................................
172.869(b)(10) ...................
Sucrose oligoesters ........................................
172.869(b)(11) ...................
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21 CFR Section
Sucrose oligoesters ........................................
173.160(d) .........................
Candida gulliermondii .....................................
173.165(d) .........................
Candida lipolytica ...........................................
173.228(a) .........................
173.280(c) ..........................
Ethyl acetate ..................................................
Solvent extraction process for citric acid .......
Meets FCC 7 specifications.
Meets FCC 7 specifications.
Meets FCC 7 specifications.
Meets FCC 7 specifications.
Meets FCC 7 specifications.
Residual isopropyl alcohol limit not to exceed 0.075% by the procedure described in the Gellan Gum monograph in FCC 7.
Conforms to FCC 7 identity and specifications.
Acid value not greater than 2, and hydroxyl value, not greater than
56 as determined by ‘‘Acid Value’’ and ‘‘Hydroxyl Value’’ methods.
Meets FCC 7 specifications.
Fluoride content not more than 30 milligrams per kilogram (mg/kg)
as determined by Method III of the Fluoride Limit Test (We have
amended the specification for fluoride content in acesulfame potassium in § 172.800(b)(2) to replace ‘‘parts per million’’ with ‘‘mg/
kg’’ to be consistent with terminology used elsewhere in the regulations cited in this rule.).
Meets FCC 7 specifications.
Meets FCC 7 specifications.
Meets FCC 7 specifications.
Meets FCC 7 specifications.
Meets FCC 7 specifications.
Meets FCC 7 specifications except that titer (solidification point)
shall not exceed 13.5 degrees Celsius and unsaponifiable matter
shall not exceed 0.5%.
Meets FCC 7 specifications.
Acid value not more than 4.0 as determined by the method ‘‘Acid
Value,’’ Appendix VII, Method I (Commercial Fatty Acids).
Residue on ignition not more than 0.7% as determined by ‘‘Residue
on Ignition,’’ Appendix IIC, Method I (using a 1 gram sample).
Residual methanol not more than 10 mg/kg as determined by the
method listed in the monograph for ‘‘Sucrose Fatty Acid Esters’’.
Residual dimethyl sulfoxide not more than 2.0 mg/kg as determined
by the method listed in the monograph ‘‘Sucrose Fatty Acid
Esters’’.
Residual isobutyl alcohol not more than 10 mg/kg as determined by
the method listed in the monograph ‘‘Sucrose Fatty Acid Esters’’.
Lead not more than 1.0 mg/kg as determined by ‘‘Atomic Absorption Spectrophotometric Graphite Furnace Method,’’ Method I.
Citric acid produced must conform to FCC 7 specifications (under
‘‘Citric acid’’).
Citric acid produced must conform to FCC 7 specifications (under
‘‘Citric acid’’).
Meets FCC 7 specifications.
Citric acid produced must conform to FCC 7 specifications (under
‘‘Citric acid’’).
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TABLE 1—LIST OF REGULATIONS—Continued
21 CFR Section
Name of Additive
FCC 7 Reference
173.310(c) ..........................
Boiler
water
additives;
carboxymethylcellulose.
173.310(c) ..........................
Boiler water additives; Sorbitol anhydride
esters.
173.368(c) ..........................
178.1005(c) ........................
Ozone .............................................................
Hydrogen peroxide solution ...........................
180.37(b) ...........................
Saccharin, ammonium saccharin, calcium
saccharin, and sodium saccharin.
The petitioner also requested
amending § 173.115(b)(3) (Alphaacetolactate decarboxylase (a-ALDC)
enzyme preparation derived from a
recombinant Bacillus subtilis). The
current regulation requires that the
enzyme preparation should meet the
general and additional requirements for
enzyme preparations found in FCC IV.
FCC 7 specifically includes a-ALDC in
the list of enzyme preparations, but does
not contain an assay method specific to
a-ALDC. We are not amending
§ 173.115(b)(3) at this time to
incorporate by reference the
specifications in FCC 7 because the
assay method for a-ALDC has been
omitted from FCC 7.
Additionally, on our own initiative,
we are amending certain provisions in
parts 172, 173, 178, and 180 to update
the address at which copies of FCC 7
can be examined. In most cases, the
existing regulations refer to an FDA
address at ‘‘5100 Paint Branch Pkwy.,
College Park, MD 20740.’’ However, in
2013, we consolidated our library
holdings at our main library at 10903
New Hampshire Ave., Silver Spring, MD
20993. Therefore, we are amending
various provisions to reflect the current
FDA address at which copies of FCC 7
can be examined.
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III. Conclusion
We reviewed data in the petition and
other relevant material and conclude
that the proposed amendments to the
regulations listed in table 1 to
incorporate by reference food-grade
specifications and analytical
methodologies from FCC 7, as discussed
in Section II of this document, are safe
and appropriate. Therefore, we are
amending parts 172, 173, 178, and 180
as set forth in this document.
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Sodium
Contains not less than 95% sodium carboxymethylcellulose on a
dry-weight basis, with maximum substitution of 0.9
carboxymethylcellulose groups per anhydroglucose unit, and with
a minimum viscosity of 15 centipoises for 2% by weight aqueous
determined by the ‘‘Viscosity of Cellulose Gum’’ method cited in
FCC 7.
Polysorbate 20 present in sorbitol anhydride esters meets FCC 7
specifications (We have amended the limitation for sorbitol anhydride esters in § 173.310(c) to replace ‘‘parts per million’’ with
‘‘mg/kg’’ to be consistent with terminology used elsewhere in the
regulations cited in this rule.).
Meets FCC 7 specifications.
Meets FCC 7 specifications (We are also amending the regulation
to incorporate by reference the United States Pharmacopeia,
36th Revision.).
Meets FCC 7 specifications.
IV. Public Availability of Documents
In accordance with § 171.1(h) (21 CFR
171.1(h)), the petition and the
documents that we considered and
relied upon in reaching our decision to
approve the petition will be made
available for public disclosure (see FOR
FURTHER INFORMATION CONTACT). As
provided in § 171.1(h), we will delete
from the documents any materials that
are not available for public disclosure.
V. Environmental Impact
Under part H in § 171.1(c), either an
environmental assessment under 21
CFR 25.40 or a claim of categorical
exclusion under § 25.30 (21 CFR 25.30)
or § 25.32 (21 CFR 25.32) is required to
be submitted with a food additive
petition. As initially filed by U.S.P., the
petition contained a claim of categorical
exclusion under § 25.30(i), which
applies to corrections and technical
changes in regulations. We reviewed the
petitioner’s claim of categorical
exclusion and stated in our original
filing notice of August 10, 2010, that we
agreed that, under § 25.30(i), the
proposed action was of a type that
would not individually or cumulatively
have a significant effect on the human
environment and therefore that neither
an environmental assessment nor an
environmental impact statement would
be required.
However, upon further review, we
decided that as a group, the actions
being requested are neither corrections
nor technical changes and therefore the
categorical exclusion in § 25.30(i) would
not be applicable. Accordingly we
announced, in an amended filing notice
published in the Federal Register of
January 18, 2012 (77 FR 2492), that
U.S.P. had submitted an environmental
assessment for the petition in lieu of a
claim of categorical exclusion and that
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we would review the potential
environmental impact of the petition.
We placed the petitioner’s
environmental assessment on display in
the Division of Dockets Management for
public review and comment.
We have carefully reviewed the
environmental assessment and
considered the potential environmental
effects of this action. We have
concluded that the action will not have
a significant impact on the human
environment, and that an environmental
impact statement is not required. Our
finding of no significant impact and the
evidence supporting that finding,
contained in the environmental
assessment, may be seen in the Division
of Dockets Management (see ADDRESSES)
between 9 a.m. and 4 p.m., Monday
through Friday.
VI. Paperwork Reduction Act of 1995
This final rule contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 is not required.
VII. Objections
If you will be adversely affected by
one or more provisions of this
regulation, you may file with the
Division of Dockets Management (see
ADDRESSES) either electronic or written
objections. You must separately number
each objection, and within each
numbered objection you must specify
with particularity the provision(s) to
which you object and the grounds for
your objection. Within each numbered
objection, you must specifically state
whether you are requesting a hearing on
the particular provision that you specify
in that numbered objection. If you do
not request a hearing for any particular
objection, you waive the right to a
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hearing on that objection. If you request
a hearing, your objection must include
a detailed description and analysis of
the specific factual information you
intend to present in support of the
objection in the event that a hearing is
held. If you do not include such a
description and analysis for any
particular objection, you waive the right
to a hearing on the objection. It is only
necessary to send one set of documents.
Identify documents with the docket
number found in brackets in the
heading of this document. Any
objections received in response to the
regulation may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov.
VIII. Section 301(ll) of the Federal
Food, Drug, and Cosmetic Act
Our review of this petition was
limited to section 409 of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 348). This final
rule is not a statement regarding
compliance with other sections of the
FD&C Act. For example, the Food and
Drug Administration Amendments Act
of 2007, which was signed into law on
September 27, 2007, amended the FD&C
Act to, among other things, add section
301(ll) of the FD&C Act (21 U.S.C.
331(ll)). Section 301(ll) of the FD&C Act
prohibits the introduction or delivery
for introduction into interstate
commerce of any food that contains a
drug approved under section 505 of the
FD&C Act (21 U.S.C. 355), a biological
product licensed under section 351 of
the Public Health Service Act (42 U.S.C.
262), or a drug or biological product for
which substantial clinical investigations
have been instituted and their existence
has been made public, unless one of the
exceptions in section 301(ll)(1) to (ll)(4)
of the FD&C Act applies. In our review
of this petition, we did not consider
whether section 301(ll) of the FD&C Act
or any of its exemptions apply to food
containing these additives. Accordingly,
this final rule should not be construed
to be a statement that a food containing
these additives, if introduced or
delivered for introduction into interstate
commerce, would not violate section
301(ll) of the FD&C Act. Furthermore,
this language is included in all food
additive final rules and therefore should
not be construed to be a statement of the
likelihood that section 301(ll) of the
FD&C Act applies.
21 CFR Part 173
IX. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
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1. FDA Memorandum from D. Folmer to M.
Honigfort, October 24, 2011.
2. FDA Memorandum from D. Folmer to M.
Honigfort, February 8, 2013.
3. FDA Memorandum from D. Folmer to M.
Honigfort, February 27, 2013.
4. FDA Memorandum from D. Folmer to M.
Honigfort, October 31, 2013.
21 CFR Part 172
Food additives, Incorporation by
reference, Reporting and recordkeeping
requirements.
Food additives, Incorporation by
reference.
21 CFR Part 178
Food additives, Food packaging,
Incorporation by reference.
21 CFR Part 180
Food additives, Incorporation by
reference.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Director, Center for Food Safety and
Applied Nutrition, 21 CFR parts 172,
173, 178, and 180 are amended as
follows:
PART 172—FOOD ADDITIVES
PERMITTED FOR DIRECT ADDITION
TO FOOD FOR HUMAN
CONSUMPTION
1. The authority citation for 21 CFR
part 172 continues to read as follows:
■
Authority: 21 U.S.C. 321, 341, 342, 348,
371, 379e.
2. Amend § 172.167 by revising
paragraph (b) to read as follows:
■
§ 172.167 Silver nitrate and hydrogen
peroxide solution.
*
*
*
*
*
(b) Hydrogen peroxide meets the
specifications of the Food Chemicals
Codex, 7th ed. (2010), pp. 496–497,
which is incorporated by reference. The
Director of the Office of the Federal
Register approves this incorporation by
reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may
obtain copies from the United States
Pharmacopeial Convention, 12601
Twinbrook Pkwy., Rockville, MD 20852
(Internet address https://www.usp.org).
Copies may be examined at the Food
PO 00000
Frm 00027
Fmt 4700
and Drug Administration’s Main
Library, 10903 New Hampshire Ave.,
Bldg. 2, Third Floor, Silver Spring, MD
20993, 301–796–2039, or at the National
Archives and Records Administration
(NARA). For information on the
availability of this material at NARA,
call 202–741–6030 or go to: https://
www.archives.gov/federal-register/cfr/
ibr-locations.html.
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*
■ 3. Revise § 172.320 to read as follows:
§ 172.320
List of Subjects
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Amino acids.
The food additive amino acids may be
safely used as nutrients added to foods
in accordance with the following
conditions:
(a) The food additive consists of one
or more of the following individual
amino acids in the free, hydrated, or
anhydrous form, or as the
hydrochloride, sodium, or potassium
salts:
(1) L-Alanine
(2) L-Arginine
(3) L-Asparagine
(4) L-Aspartic acid
(5) L-Cysteine
(6) L-Cystine
(7) L-Glutamic acid
(8) L-Glutamine
(9) Aminoacetic acid (glycine)
(10) L-Histidine
(11) L-Isoleucine
(12) L-Leucine
(13) L-Lysine
(14) DL-Methionine (not for infant
foods)
(15) L-Methionine
(16) L-Phenylalanine
(17) L-Proline
(18) L-Serine
(19) L-Threonine
(20) L-Tryptophan
(21) L-Tyrosine
(22) L-Valine
(b) The food additive meets the
following specifications:
(1) As found in Food Chemicals
Codex:
(i) L-Alanine, pages 28 and 29.
(ii) L-Arginine, pages 69 and 70.
(iii) L-Arginine Monohydrochloride,
pages 70 and 71.
(iv) L-Cysteine Monohydrochloride,
pages 269 and 270.
(v) L-Cystine, pages 270 and 271.
(vi) Aminoacetic acid (glycine), pages
457 and 458.
(vii) L-Leucine, pages 577 and 578.
(viii) DL-Methionine, pages 641 and
642.
(ix) L-Methionine, pages 642 and 643.
(x) L-Tryptophan, pages 1060 and 1061.
(xi) L-Phenylalanine, pages 794 and 795.
(xii) L-Proline, pages 864 and 865.
(xiii) L-Serine, pages 915 and 916.
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(xiv) L-Threonine, pages 1031 and 1032.
(xv) L-Glutamic Acid Hydrochloride,
page 440.
(xvi) L-Isoleucine, pages 544 and 545.
(xvii) L-Lysine Monohydrochloride,
pages 598 and 599.
(xviii) Monopotassium L-glutamate,
pages 697 and 698.
(xix) L-Tyrosine, page 1061.
(xx) L-Valine, pages 1072.
(2) As found in ‘‘Specifications and
Criteria for Biochemical Compounds,’’
NAS/NRC Publication, for the
following:
(i) L-Asparagine
(ii) L-Aspartic acid
(iii) L-Glutamine
(iv) L-Histidine
(c) The additive(s) is used or intended
for use to significantly improve the
biological quality of the total protein in
a food containing naturally occurring
primarily intact protein that is
considered a significant dietary protein
source, provided that:
(1) A reasonable daily adult intake of
the finished food furnishes at least 6.5
grams of naturally occurring primarily
intact protein (based upon 10 percent of
the daily allowance for the ‘‘reference’’
adult male recommended by the
National Academy of Sciences in
‘‘Recommended Dietary Allowances,’’
NAS Publication No. 1694.
(2) The additive(s) results in a protein
efficiency ratio (PER) of protein in the
finished ready-to-eat food equivalent to
casein as determined by the method
specified in paragraph (d) of this
section.
(3) Each amino acid (or combination
of the minimum number necessary to
achieve a statistically significant
increase) added results in a statistically
significant increase in the PER as
determined by the method described in
paragraph (d) of this section. The
minimum amount of the amino acid(s)
to achieve the desired effect must be
used and the increase in PER over the
primarily intact naturally occurring
protein in the food must be
substantiated as a statistically
significant difference with at least a
probability (P) value of less than 0.05.
(4) The amount of the additive added
for nutritive purposes plus the amount
naturally present in free and combined
(as protein) form does not exceed the
following levels of amino acids
expressed as percent by weight of the
total protein of the finished food:
Percent by weight of total
protein (expressed as free
amino acid)
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L-Alanine ....................................................................................................................................................................
L-Arginine ...................................................................................................................................................................
L-Aspartic acid (including L-asparagine) ...................................................................................................................
L-Cystine (including L-cysteine) ................................................................................................................................
L-Glutamic acid (including L-glutamine) ....................................................................................................................
Aminoacetic acid (glycine) .........................................................................................................................................
L-Histidine ..................................................................................................................................................................
L-Isoleucine ................................................................................................................................................................
L-Leucine ...................................................................................................................................................................
L-Lysine .....................................................................................................................................................................
L- and DL-Methionine ................................................................................................................................................
L-Phenylalanine .........................................................................................................................................................
L-Proline .....................................................................................................................................................................
L-Serine .....................................................................................................................................................................
L-Threonine ................................................................................................................................................................
L-Tryptophan ..............................................................................................................................................................
L-Tyrosine ..................................................................................................................................................................
L-Valine ......................................................................................................................................................................
(d) Compliance with the limitations
concerning PER under paragraph (c) of
this section shall be determined by the
method described in sections 43.212–
43.216, ‘‘Official Methods of Analysis of
the Association of Official Analytical
Chemists.’’ Each manufacturer or person
employing the additive(s) under the
provisions of this section shall keep and
maintain throughout the period of his
use of the additive(s) and for a
minimum of 3 years thereafter, records
of the tests required by this paragraph
and other records required to assure
effectiveness and compliance with this
regulation and shall make such records
available upon request at all reasonable
hours by any officer or employee of the
Food and Drug Administration, or any
other officer or employee acting on
behalf of the Secretary of Health and
Human Services and shall permit such
officer or employee to conduct such
inventories of raw and finished
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20:31 Nov 27, 2013
Jkt 232001
materials on hand as he deems
necessary and otherwise to check the
correctness of such records.
(e) To assure safe use of the additive,
the label and labeling of the additive
and any premix thereof shall bear, in
addition to the other information
required by the Act, the following:
(1) The name of the amino acid(s)
contained therein including the specific
optical and chemical form.
(2) The amounts of each amino acid
contained in any mixture.
(3) Adequate directions for use to
provide a finished food meeting the
limitations prescribed by paragraph (c)
of this section.
(f) The food additive amino acids
added as nutrients to special dietary
foods that are intended for use solely
under medical supervision to meet
nutritional requirements in specific
medical conditions and comply with the
requirements of part 105 of this chapter
are exempt from the limitations in
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Sfmt 4700
6.1
6.6
7.0
2.3
12.4
3.5
2.4
6.6
8.8
6.4
3.1
5.8
4.2
8.4
5.0
1.6
4.3
7.4
paragraphs (c) and (d) of this section
and may be used in such foods at levels
not to exceed good manufacturing
practices.
(g) The standards required in this
section are incorporated by reference
into this section with the approval of
the Director of the Federal Register
under 5 U.S.C. 552(a) and 1 CFR part 51.
Copies may be examined at the Food
and Drug Administration’s Main
Library, 10903 New Hampshire Ave.,
Bldg. 2, Third Floor, Silver Spring, MD
20993, 301–796–2039, or at the National
Archives and Records Administration
(NARA). For information on the
availability of this material at NARA,
call 202–741–6030 or go to: https://
www.archives.gov/federal-register/cfr/
ibr-locations.html.
(1) AOAC INTERNATIONAL, 481
North Frederick Ave., suite 500,
Gaithersburg, MD 20877:
(i) Sections 43.212–43.216, ‘‘Official
Methods of Analysis of the Association
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of Official Analytical Chemists,’’ 13th
Ed. (1980).
(ii) [Reserved].
(2) National Academy of Sciences,
available from the FDA Main Library,
10903 New Hampshire Ave., Silver
Spring, MD 20993:
(i) ‘‘Recommended Dietary
Allowances,’’ NAS Publication No.
1694, 7th Ed. (1968).
(ii) ‘‘Specifications and Criteria for
Biochemical Compounds,’’ NAS/NRC
Publication, 3rd Ed. (1972).
(3) United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address
https://www.usp.org):
(i) Food Chemicals Codex, 7th ed.
(2010), pages 28, 29, 69, 70, 71, 269,
270, 271, 440, 457, 458, 544, 545, 577,
578, 598, 599, 641, 642, 643, 697, 698,
794, 795, 864, 865, 915, 916, 1031, 1032,
1060, 1061, and 1072.
(ii) [Reserved].
■ 4. Amend § 172.345 by revising
paragraph (b) to read as follows:
§ 172.345
Folic acid (folacin).
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*
*
*
(b) Folic acid meets the specifications
of the Food Chemicals Codex, 7th ed.
(2010), pp. 406–407, which is
incorporated by reference. The Director
of the Office of the Federal Register
approves this incorporation by reference
in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. You may obtain copies
from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address
https://www.usp.org). Copies may be
examined at the Food and Drug
Administration’s Main Library, 10903
New Hampshire Ave., Bldg. 2, Third
Floor, Silver Spring, MD 20993, 301–
796–2039, or at the National Archives
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030 or go to: https://www.archives.gov/
federal-register/cfr/ibr-locations.html.
*
*
*
*
*
■ 5. Amend § 172.379 by revising
paragraph (b) to read as follows:
§ 172.379
Vitamin D2.
sroberts on DSK5SPTVN1PROD with RULES
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*
(b) Vitamin D2 meets the
specifications of the Food Chemicals
Codex, 7th ed. (2010), pp. 1080–1081,
which is incorporated by reference. The
Director of the Office of the Federal
Register approves this incorporation by
reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may
obtain copies from the United States
Pharmacopeial Convention, 12601
Twinbrook Pkwy., Rockville, MD 20852
VerDate Mar<15>2010
20:31 Nov 27, 2013
Jkt 232001
(Internet address https://www.usp.org).
Copies may be examined at the Food
and Drug Administration’s Main
Library, 10903 New Hampshire Ave.,
Bldg. 2, Third Floor, Silver Spring, MD
20993, 301–796–2039, or at the National
Archives and Records Administration
(NARA). For information on the
availability of this material at NARA,
call 202–741–6030 or go to: https://
www.archives.gov/federal-register/cfr/
ibr-locations.html.
*
*
*
*
*
■ 6. Amend § 172.380 by revising
paragraph (b) to read as follows:
§ 172.380
Vitamin D3.
*
*
*
*
*
(b) Vitamin D3 meets the
specifications of the Food Chemicals
Codex, 7th ed. (2010), pp. 1081–1082,
which is incorporated by reference. The
Director of the Office of the Federal
Register approves this incorporation by
reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may
obtain copies from the United States
Pharmacopeial Convention, 12601
Twinbrook Pkwy., Rockville, MD 20852
(Internet address https://www.usp.org).
Copies may be examined at the Food
and Drug Administration’s Main
Library, 10903 New Hampshire Ave.,
Bldg. 2, Third Floor, Silver Spring, MD
20993, 301–796–2039, or at the National
Archives and Records Administration
(NARA). For information on the
availability of this material at NARA,
call 202–741–6030 or go to: https://
www.archives.gov/federal-register/cfr/
ibr-locations.html.
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*
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*
■ 7. Amend § 172.665 by revising
paragraph (d)(2) to read as follows:
§ 172.665
Gellan gum.
*
*
*
*
*
(d) * * *
(2) Residual isopropyl alcohol (IPA)
not to exceed 0.075 percent as
determined by the procedure described
in the ‘‘Gellan gum’’ monograph in the
Food Chemicals Codex, 7th ed. (2010),
pp. 425–426, which is incorporated by
reference. The Director of the Office of
the Federal Register approves this
incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1
CFR part 51. You may obtain copies
from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address
https://www.usp.org). Copies may be
examined at the Food and Drug
Administration’s Main Library, 10903
New Hampshire Ave., Bldg. 2, Third
Floor, Silver Spring, MD 20993, 301–
796–2039, or at the National Archives
PO 00000
Frm 00029
Fmt 4700
Sfmt 4700
71463
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030 or go to: https://www.archives.gov/
federal-register/cfr/ibr-locations.html.
*
*
*
*
*
■ 8. Amend § 172.712 by revising
paragraph (b) to read as follows:
§ 172.712
1,3-Butylene glycol.
*
*
*
*
*
(b) The food additive shall conform to
the identity and specifications of the
Food Chemicals Codex, 7th ed. (2010),
p. 126, which is incorporated by
reference. The Director of the Office of
the Federal Register approves this
incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1
CFR part 51. You may obtain copies
from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address
https://www.usp.org). Copies may be
examined at the Food and Drug
Administration’s Main Library, 10903
New Hampshire Ave., Bldg. 2, Third
Floor, Silver Spring, MD 20993, 301–
796–2039, or at the National Archives
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030 or go to: https://www.archives.gov/
federal-register/cfr/ibr-locations.html.
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*
*
*
9. Amend § 172.736 by revising
paragraph (b)(2) to read as follows:
■
§ 172.736 Glycerides and polyglycides of
hydrogenated vegetable oils.
*
*
*
*
*
(b) * * *
(2) Acid value, not greater than 2, and
hydroxyl value, not greater than 56, as
determined by the methods entitled
‘‘Acid Value,’’ p. 1220 and ‘‘Hydroxyl
Value,’’ p. 1223, respectively, in the
Food Chemicals Codex, 7th ed. (2010),
which is incorporated by reference. The
Director of the Office of the Federal
Register approves this incorporation by
reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may
obtain copies from the United States
Pharmacopeial Convention, 12601
Twinbrook Pkwy., Rockville, MD 20852
(Internet address https://www.usp.org).
Copies may be examined at the Food
and Drug Administration’s Main
Library, 10903 New Hampshire Ave.,
Bldg. 2, Third Floor, Silver Spring, MD
20993, 301–796–2039, or at the National
Archives and Records Administration
(NARA). For information on the
availability of this material at NARA,
call 202–741–6030 or go to: https://
E:\FR\FM\29NOR1.SGM
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www.archives.gov/federal-register/cfr/
ibr-locations.html.
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*
■ 10. Amend § 172.780 by revising
paragraph (b) to read as follows:
§ 172.780
Acacia (gum arabic).
*
*
*
*
*
(b) The ingredient meets the
specifications of the Food Chemicals
Codex, 7th ed. (2010), p. 460, which is
incorporated by reference. The Director
of the Office of the Federal Register
approves this incorporation by reference
in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. You may obtain copies
from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address
https://www.usp.org). Copies may be
examined at the Food and Drug
Administration’s Main Library, 10903
New Hampshire Ave., Bldg. 2, Third
Floor, Silver Spring, MD 20993, 301–
796–2039, or at the National Archives
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030 or go to: https://www.archives.gov/
federal-register/cfr/ibr-locations.html.
*
*
*
*
*
■ 11. Amend § 172.800 by revising
paragraph (b)(2) to read as follows:
§ 172.800
Acesulfame potassium.
sroberts on DSK5SPTVN1PROD with RULES
*
*
*
*
*
(b) * * *
(2) Fluoride content is not more than
30 milligrams per kilogram, as
determined by method III of the
Fluoride Limit Test of the Food
Chemicals Codex, 7th ed. (2010), p.
1151, which is incorporated by
reference. The Director of the Office of
the Federal Register approves this
incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1
CFR part 51. You may obtain copies
from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address
https://www.usp.org). Copies may be
examined at the Food and Drug
Administration’s Main Library, 10903
New Hampshire Ave., Bldg. 2, Third
Floor, Silver Spring, MD 20993, 301–
796–2039, or at the National Archives
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030 or go to: https://www.archives.gov/
federal-register/cfr/ibr-locations.html.
*
*
*
*
*
■ 12. Amend § 172.804 by revising
paragraph (b) to read as follows:
§ 172.804
Aspartame.
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*
*
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*
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Jkt 232001
(b) The additive meets the
specifications of the Food Chemicals
Codex, 7th ed. (2010), pp. 73–74, which
is incorporated by reference. The
Director of the Office of the Federal
Register approves this incorporation by
reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may
obtain copies from the United States
Pharmacopeial Convention, 12601
Twinbrook Pkwy., Rockville, MD 20852
(Internet address https://www.usp.org).
Copies may be examined at the Food
and Drug Administration’s Main
Library, 10903 New Hampshire Ave.,
Bldg. 2, Third Floor, Silver Spring, MD
20993, 301–796–2039, or at the National
Archives and Records Administration
(NARA). For information on the
availability of this material at NARA,
call 202–741–6030 or go to: https://
www.archives.gov/federal-register/cfr/
ibr-locations.html.
*
*
*
*
*
■ 13. Revise the introductory text of
§ 172.810 to read as follows:
§ 172.810
Dioctyl sodium sulfosuccinate.
The food additive, dioctyl sodium
sulfosuccinate, meets the specifications
of the Food Chemicals Codex, 7th ed.
(2010), pp. 313–314, which is
incorporated by reference. The Director
of the Office of the Federal Register
approves this incorporation by reference
in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. You may obtain copies
from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address
https://www.usp.org). Copies may be
examined at the Food and Drug
Administration’s Main Library, 10903
New Hampshire Ave., Bldg. 2, Third
Floor, Silver Spring, MD 20993, 301–
796–2039, or at the National Archives
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030 or go to: https://www.archives.gov/
federal-register/cfr/ibr-locations.html).
The food additive, dioctyl sodium
sulfosuccinate, may be safely used in
food in accordance with the following
prescribed conditions:
*
*
*
*
*
■ 14. Amend § 172.812 by revising
paragraph (a) to read as follows:
§ 172.812
Glycine.
*
*
*
*
*
(a) The additive meets the
specifications of the Food Chemicals
Codex, 7th ed. (2010), pp. 457–458,
which is incorporated by reference. The
Director of the Office of the Federal
Register approves this incorporation by
reference in accordance with 5 U.S.C.
PO 00000
Frm 00030
Fmt 4700
Sfmt 4700
552(a) and 1 CFR part 51. You may
obtain copies from the United States
Pharmacopeial Convention, 12601
Twinbrook Pkwy., Rockville, MD 20852
(Internet address https://www.usp.org).
Copies may be examined at the Food
and Drug Administration’s Main
Library, 10903 New Hampshire Ave.,
Bldg. 2, Third Floor, Silver Spring, MD
20993, 301–796–2039, or at the National
Archives and Records Administration
(NARA). For information on the
availability of this material at NARA,
call 202–741–6030 or go to: https://
www.archives.gov/federal-register/cfr/
ibr-locations.html.
*
*
*
*
*
■ 15. Amend § 172.831 by revising
paragraph (b) to read as follows:
§ 172.831
Sucralose.
*
*
*
*
*
(b) The additive meets the
specifications of the Food Chemicals
Codex, 7th ed. (2010), pp. 993–995,
which is incorporated by reference. The
Director of the Office of the Federal
Register approves this incorporation by
reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may
obtain copies from the United States
Pharmacopeial Convention, 12601
Twinbrook Pkwy., Rockville, MD 20852
(Internet address https://www.usp.org).
Copies may be examined at the Food
and Drug Administration’s Main
Library, 10903 New Hampshire Ave.,
Bldg. 2, Third Floor, Silver Spring, MD
20993, 301–796–2039, or at the National
Archives and Records Administration
(NARA). For information on the
availability of this material at NARA,
call 202–741–6030 or go to: https://
www.archives.gov/federal-register/cfr/
ibr-locations.html.
*
*
*
*
*
■ 16. Amend § 172.841 by revising
paragraph (b) to read as follows:
§ 172.841
Polydextrose.
*
*
*
*
*
(b) The additive meets the
specifications of the Food Chemicals
Codex, 7th ed. (2010), pp. 811–814,
which is incorporated by reference. The
Director of the Office of the Federal
Register approves this incorporation by
reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may
obtain copies from the United States
Pharmacopeial Convention, 12601
Twinbrook Pkwy., Rockville, MD 20852
(Internet address https://www.usp.org).
Copies may be examined at the Food
and Drug Administration’s Main
Library, 10903 New Hampshire Ave.,
Bldg. 2, Third Floor, Silver Spring, MD
20993, 301–796–2039, or at the National
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Archives and Records Administration
(NARA). For information on the
availability of this material at NARA,
call 202–741–6030 or go to: https://
www.archives.gov/federal-register/cfr/
ibr-locations.html.
*
*
*
*
*
■ 17. Amend § 172.862 by revising
paragraph (b)(1) to read as follows:
§ 172.862 Oleic acid derived from tall oil
fatty acids.
Floor, Silver Spring, MD 20993, 301–
796–2039, or at the National Archives
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030 or go to: https://www.archives.gov/
federal-register/cfr/ibr-locations.html.
*
*
*
*
*
■ 18. Amend § 172.867 by revising
paragraph (b) to read as follows:
§ 172.867
*
*
*
*
*
(b) * * *
(1) Specifications for oleic acid
prescribed in the Food Chemicals
Codex, 7th ed. (2010), pp. 743–744,
which is incorporated by reference,
except that titer (solidification point)
shall not exceed 13.5 °C and
unsaponifiable matter shall not exceed
0.5 percent. The Director of the Office
of the Federal Register approves this
incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1
CFR part 51. You may obtain copies
from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address
https://www.usp.org). Copies may be
examined at the Food and Drug
Administration’s Main Library, 10903
New Hampshire Ave., Bldg. 2, Third
Olestra.
*
*
*
*
*
(b) Olestra meets the specifications of
the Food Chemicals Codex, 7th ed.
(2010), pp. 744–746, which is
incorporated by reference. The Director
of the Office of the Federal Register
approves this incorporation by reference
in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. You may obtain copies
from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address
https://www.usp.org). Copies may be
examined at the Food and Drug
Administration’s Main Library, 10903
New Hampshire Ave., Bldg. 2, Third
Floor, Silver Spring, MD 20993, 301–
796–2039, or at the National Archives
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030 or go to: https://www.archives.gov/
federal-register/cfr/ibr-locations.html.
*
*
*
*
*
■ 19. Amend § 172.869 by revising
paragraph (b) introductory text and
paragraphs (b)(6) through (b)(11) to read
as follows:
§ 172.869
Sucrose oligoesters.
*
*
*
*
*
(b) Sucrose oligoesters meet the
specifications in the methods listed in
the table in this paragraph. The methods
for determining compliance with each
specification are incorporated by
reference. The Director of the Office of
the Federal Register approves this
incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1
CFR part 51. Copies may be examined
at the Food and Drug Administration’s
Main Library, 10903 New Hampshire
Ave., Bldg. 2, Third Floor, Silver Spring,
MD 20993, 301–796–2039, or at the
National Archives and Records
Administration (NARA). For
information on the availability of this
material at NARA, call 202–741–6030 or
go to: https://www.archives.gov/federalregister/cfr/ibr-locations.html. Copies of
the methods are available from the
sources listed in the table in this
paragraph:
Limit
Method cited
Source for obtaining method
*
(6) Acid Value .............
*
Not more than 4.0 ......
Not more than 0.7% ..
(8) Residual Methanol
Not more than 10 milligrams/kilogram.
(9) Residual Dimethyl
Sulfoxide.
(10) Residual Isobutyl
Alcohol.
(11) Lead ....................
Not more than 2.0 milligrams/kilogram.
Not more than 10 milligrams/kilogram.
Not more than 1.0 milligram/kilogram.
*
*
‘‘Acid Value,’’ Appendix VII,
Method I (Commercial Fatty
Acids), in the Food Chemicals Codex, 7th ed. (2010),
p. 1220..
‘‘Residue on Ignition,’’ Appendix IIC, Method I, in the
Food Chemicals Codex, 7th
ed. (2010), pp. 1141–1142
(using a 1-gram sample)..
Method listed in the monograph for ‘‘Sucrose Fatty
Acid Esters’’ in the Food
Chemicals Codex, 7th ed.
(2010), pp. 998–1000..
......do .....................................
*
*
United States Pharmacopeial Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address https://www.usp.org)
(7) Residue on Ignition
sroberts on DSK5SPTVN1PROD with RULES
Specification
Do.
......do .....................................
Do.
‘‘Atomic Absorption
Spectrophometric Graphite
Furnace Method,’’ Method I
in the Food Chemicals
Codex, 7th ed. (2010), p.
1154–1155.
Do.
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*
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*
PART 173—SECONDARY DIRECT
FOOD ADDITIVES PERMITTED IN
FOOD FOR HUMAN CONSUMPTION
20. The authority citation for 21 CFR
part 173 continues to read as follows:
■
Authority: 21 U.S.C. 321, 342, 348.
21. Amend § 173.160 by revising
paragraph (d) to read as follows:
■
§ 173.160
Candida guilliermondii.
*
*
*
*
*
(d) The additive is so used that the
citric acid produced conforms to the
specifications of the Food Chemicals
Codex, 7th ed. (2010), pp. 226–227,
which is incorporated by reference. The
Director of the Office of the Federal
Register approves this incorporation by
reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may
obtain copies from the United States
Pharmacopeial Convention, 12601
Twinbrook Pkwy., Rockville, MD 20852
(Internet address https://www.usp.org).
Copies may be examined at the Food
and Drug Administration’s Main
Library, 10903 New Hampshire Ave.,
Bldg. 2, Third Floor, Silver Spring, MD
20993, 301–796–2039, or at the National
Archives and Records Administration
(NARA). For information on the
availability of this material at NARA,
call 202–741–6030 or go to: https://
www.archives.gov/federal-register/cfr/
ibr-locations.html.
22. Amend § 173.165 by removing the
first three sentences in paragraph (d)
and adding five sentences in their place
to read as follows:
■
§ 173.165
Candida lipolytica.
*
*
*
*
*
(d) The additive is so used that the
citric acid produced conforms to the
specifications of the Food Chemicals
Codex, 7th ed. (2010), pp. 226–227,
which is incorporated by reference. The
Director of the Office of the Federal
Register approves this incorporation by
reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may
obtain copies from the United States
Pharmacopeial Convention, 12601
Twinbrook Pkwy., Rockville, MD 20852
(Internet address https://www.usp.org).
Copies may be examined at the Food
and Drug Administration’s Main
Library, 10903 New Hampshire Ave.,
Bldg. 2, Third Floor, Silver Spring, MD
20993, 301–796–2039, or at the National
Archives and Records Administration
(NARA). For information on the
availability of this material at NARA,
call 202–741–6030 or go to: https://
www.archives.gov/federal-register/cfr/
ibr-locations.html. * * *
*
*
*
*
*
■ 23. Amend § 173.228 by revising
paragraph (a) and removing footnote 1
to read as follows:
§ 173.228
Ethyl acetate.
*
*
*
*
*
(a) The additive meets the
specifications of the Food Chemicals
Codex, 7th ed. (2010), pp. 343–344,
which is incorporated by reference. The
Director of the Office of the Federal
Register approves this incorporation by
reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may
obtain copies from the United States
Pharmacopeial Convention, 12601
Twinbrook Pkwy., Rockville, MD 20852
(Internet address https://www.usp.org).
Copies may be examined at the Food
and Drug Administration’s Main
Library, 10903 New Hampshire Ave.,
Bldg. 2, Third Floor, Silver Spring, MD
20993, 301–796–2039, or at the National
Archives and Records Administration
(NARA). For information on the
availability of this material at NARA,
call 202–741–6030 or go to: https://
www.archives.gov/federal-register/cfr/
ibr-locations.html.
*
*
*
*
*
24. Amend § 173.280 by revising
paragraph (c) to read as follows:
■
§ 173.280 Solvent extraction process for
citric acid.
*
*
*
*
*
(c) The citric acid so produced meets
the polynuclear aromatic hydrocarbon
specifications of § 173.165 and the
specifications of the Food Chemicals
Codex, 7th ed. (2010), pp. 226–227,
which is incorporated by reference. The
Director of the Office of the Federal
Register approves this incorporation by
reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may
obtain copies from the United States
Pharmacopeial Convention, 12601
Twinbrook Pkwy., Rockville, MD 20852
(Internet address https://www.usp.org).
Copies may be examined at the Food
and Drug Administration’s Main
Library, 10903 New Hampshire Ave.,
Bldg. 2, Third Floor, Silver Spring, MD
20993, 301–796–2039, or at the National
Archives and Records Administration
(NARA). For information on the
availability of this material at NARA,
call 202–741–6030 or go to: https://
www.archives.gov/federal-register/cfr/
ibr-locations.html.
*
*
*
*
*
25. Amend § 173.310 in the table in
paragraph (c) by revising the entries for
‘‘Acrylic acid/2-acrylamido-2-methyl
propane sulfonic acid copolymer’’,
‘‘Sodium carboxymethylcellulose’’, and
‘‘Sorbitol anhydride esters’’ and add
paragraph (f) to read as follows:
■
§ 173.310
*
Boiler water additives.
*
*
*
*
(c) List of substances:
Substances
Limitations
sroberts on DSK5SPTVN1PROD with RULES
*
*
*
*
*
*
*
Acrylic acid/2-acrylamido-2-methyl propane sulfonic acid copolymer Total not to exceed 20 parts per million (active) in boiler feedwater.
having a minimum weight average molecular weight of 9,900 and a
minimum number average molecular weight of 5,700 as determined
by a method entitled ‘‘Determination of Weight Average and Number
Average Molecular Weight of 60/40 AA/AMPS’’.
*
*
*
*
*
*
*
Sodium carboxymethylcellulose ............................................................... Contains not less than 95 percent sodium carboxymethylcellulose on a
dry-weight
basis,
with
maximum
substitution
of
0.9
carboxymethylcellulose groups per anhydroglucose unit, and with a
minimum viscosity of 15 centipoises for 2 percent by weight aqueous
solution at 25 °C; by the ‘‘Viscosity of Cellulose Gum’’ method prescribed in the Food Chemicals Codex, pp. 1128–1129.
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Substances
Limitations
*
*
*
*
*
*
*
Sorbitol anhydride esters: A mixture consisting of sorbitan monostea- The mixture is used as an anticorrosive agent in steam boiler distriburate as defined in § 172. 842 of this chapter; polysorbate 60
tion systems, with each component not to exceed 15 milligrams per
((polyoxyethylene (20) sorbitan monostearate)) as defined in
kilogram in the steam.
§ 172.836 of this chapter; and polysorbate 20 ((polyoxyethylene (20)
sorbitan monolaurate)), meeting the specifications of the Food
Chemicals Codex, pp. 825–827..
*
*
*
*
*
*
*
*
(f) The standards required in this
section are incorporated by reference
into this section with the approval of
the Director of the Federal Register
under 5 U.S.C. 552(a) and 1 CFR part 51.
Copies may be examined at the Food
and Drug Administration’s Main
Library, 10903 New Hampshire Ave.,
Bldg. 2, Third Floor, Silver Spring, MD
20993, 301–796–2039, or at the National
Archives and Records Administration
(NARA). For information on the
availability of this material at NARA,
call 202–741–6030 or go to: https://
www.archives.gov/federal-register/cfr/
ibr-locations.html.
(1) FDA Main Library, 10903 New
Hampshire Ave., Silver Spring, MD
20993:
(i) ‘‘Determination of Weight Average
and Number Average Molecular Weight
of 60/40 AA/AMPS’’ (October 23, 1987).
(ii) [Reserved].
(2) United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address
https://www.usp.org):
(i) Food Chemicals Codex, 7th ed.
(2010), pp. 1128–1129.
(ii) Food Chemicals Codex, 7th ed.
(2010), pp. 825–827.
■ 26. Amend § 173.368 by revising
paragraph (c) to read as follows:
§ 173.368
Ozone.
sroberts on DSK5SPTVN1PROD with RULES
*
*
*
*
*
(c) The additive meets the
specifications for ozone in the Food
Chemicals Codex, 7th ed. (2010), pp.
754–755, which is incorporated by
reference. The Director of the Office of
the Federal Register approves this
incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1
CFR part 51. You may obtain copies
from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address
https://www.usp.org). Copies may be
examined at the Food and Drug
Administration’s Main Library, 10903
New Hampshire Ave., Bldg. 2, Third
Floor, Silver Spring, MD 20993, 301–
796–2039, or at the National Archives
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*
*
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030 or go to: https://www.archives.gov/
federal-register/cfr/ibr-locations.html.
*
*
*
*
*
PART 178—INDIRECT FOOD
ADDITIVES: ADJUVANTS,
PRODUCTION AIDS, AND SANITIZERS
*
*
PART 180—FOOD ADDITIVES
PERMITTED IN FOOD OR IN CONTACT
WITH FOOD ON AN INTERIM BASIS
PENDING ADDITIONAL STUDY
29. The authority citation for 21 CFR
part 180 continues to read as follows:
■
Authority: 21 U.S.C. 321, 342, 343, 348,
371; 42 U.S.C. 241.
30. Amend § 180.37 by revising
paragraph (b) to read as follows:
■
27. The authority citation for 21 CFR
part 178 continues to read as follows:
■
Authority: 21 U.S.C. 321, 342, 348, 379e.
28. Amend § 178.1005 by revising
paragraph (c) to read as follows:
■
§ 178.1005
Hydrogen peroxide solution.
*
*
*
*
*
(c) Specifications. Hydrogen peroxide
solution shall meet the specifications of
the Food Chemicals Codex, 7th ed.
(2010), pp. 496–497, which is
incorporated by reference. Hydrogen
peroxide solution shall also meet the
specifications for ‘‘Acidity,’’ ‘‘Chloride,’’
and ‘‘Other requirements’’ for Hydrogen
Peroxide Concentrate in the United
States Pharmacopeia 36th Revision
(2013), pp. 3848–3849, which is
incorporated by reference. The Director
of the Office of the Federal Register
approves this incorporation by reference
in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. You may obtain copies
from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address
https://www.usp.org). Copies may be
examined at the Food and Drug
Administration’s Main Library, 10903
New Hampshire Ave., Bldg. 2, Third
Floor, Silver Spring, MD 20993, 301–
796–2039, or at the National Archives
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030 or go to: https://www.archives.gov/
federal-register/cfr/ibr-locations.html.
*
*
*
*
*
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§ 180.37 Saccharin, ammonium saccharin,
calcium saccharin, and sodium saccharin.
*
*
*
*
*
(b) The food additives meet the
specifications of the Food Chemicals
Codex, 7th ed. (2010), pp. 52–54, 153–
154, 898–899, 961–962, which is
incorporated by reference. The Director
of the Office of the Federal Register
approves this incorporation by reference
in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. You may obtain copies
from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address
https://www.usp.org). Copies may be
examined at the Food and Drug
Administration’s Main Library, 10903
New Hampshire Ave., Bldg. 2, Third
Floor, Silver Spring, MD 20993, 301–
796–2039, or at the National Archives
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030 or go to: https://www.archives.gov/
federal-register/cfr/ibr-locations.html.
*
*
*
*
*
Dated: November 21, 2013.
Susan M. Bernard,
Director, Office of Regulations, Policy and
Social Sciences, Center for Food Safety and
Applied Nutrition.
[FR Doc. 2013–28439 Filed 11–27–13; 8:45 am]
BILLING CODE 4160–01–P
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[Federal Register Volume 78, Number 230 (Friday, November 29, 2013)]
[Rules and Regulations]
[Pages 71457-71467]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28439]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 172, 173, 178, and 180
[Docket No. FDA-2010-F-0320]
Food Additive Regulations; Incorporation by Reference of the Food
Chemicals Codex, 7th Edition
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending
select food additive regulations that incorporate by reference food-
grade specifications from prior editions of the Food Chemicals Codex
(FCC) to incorporate by reference food-grade specifications from the
FCC 7th Edition (FCC 7). We are taking this action in response to a
petition filed by the United States Pharmacopeial Convention (U.S.P. or
petitioner).
DATES: This rule is effective November 29, 2013. See the ``Objections''
heading of the SUPPLEMENTARY INFORMATION section for information on the
filing of objections. Submit either electronic or written objections
and requests for a hearing by December 30, 2013. The Director of the
Office of the Federal Register approves the incorporation by reference
of certain publications listed in the rule as of November 29, 2013.
ADDRESSES: You may submit either electronic or written objections and
requests for a hearing, identified by Docket No. FDA-2010-F-0320, by
any of the following methods:
Electronic Submissions
Submit electronic objections in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written objections in the following ways:
Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
[[Page 71458]]
Instructions: All submissions received must include the Agency name
and Docket No. FDA-2010-F-0320 for this rulemaking. All objections
received may be posted without change to https://www.regulations.gov,
including any personal information provided. For detailed instructions
on submitting objections, see the ``Objections'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
objections received, go to https://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Mical Honigfort, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1278.
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal Register of August 10, 2010
(75 FR 48353), we announced that the U.S.P., 12601 Twinbrook Pkwy.,
Rockville, MD 20852, had filed a food additive petition. The petition
proposed that select food additive regulations in parts 172, 173, 178,
and 180 (21 CFR parts 172, 173, 178, and 180), which incorporate by
reference food-grade specifications from prior editions of the FCC, be
amended to incorporate by reference food-grade specifications from FCC
7.
The FCC is a compendium of specification monographs for substances
used as food ingredients. The Committee on Food Chemicals Codex of the
Food and Nutrition Board, Institute of Medicine (IOM) of the National
Academies published the first through fifth editions of the FCC. In
2006, U.S.P. acquired the rights to the FCC, and subsequently published
the sixth, seventh, and eighth editions. Specifications and methods
published in the FCC have been incorporated by reference in various
sections of 21 CFR parts 73, 170, 172, 173, 178, 180, and 184.
Since acquiring rights to the FCC, U.S.P. has developed and
continues to develop standards for food ingredients through public
participation with a goal of biennial publication of the FCC. Draft
monographs and data are provided by food ingredient manufacturers,
users, and suppliers and are published for public review and comment on
U.S.P.'s Web site. U.S.P. scientists and its Food Ingredients Expert
Committee review these data and, if necessary, conduct laboratory
tests. Once approved by the Food Ingredients Expert Committee, new or
updated monographs are published in the next edition or Supplement to
the FCC.
The petitioner initially requested amendments to 39 existing
references to older editions of the FCC in parts 172, 173, 178, and 180
to incorporate by reference the specifications contained in FCC 7. The
petitioner explained that of the regulations it has requested to be
updated, 15 regulations refer to the third edition of the FCC (FCC III,
published in 1981); 18 regulations refer to the fourth edition of the
FCC (FCC IV, published in 1996); 4 regulations refer to the fifth
edition of the FCC (FCC V, published in 2004); and 2 regulations refer
to the sixth edition of the FCC (FCC 6, published in 2008). (The IOM
used roman numerals when referring to editions of the FCC, e.g., FCC
III and FCC V. U.S.P. uses numbers rather than roman numerals to refer
to the editions of FCC that it has published, e.g., FCC 6 and FCC 7.)
In most cases, the references to the FCC in the regulations are to an
entire FCC monograph. Some references, however, only refer to part of
an FCC monograph, i.e., a single specification, or to an FCC analytical
method.
After discussions with us in July 2011, the petitioner subsequently
narrowed its petition to exclude six regulations ((Sec. Sec.
172.172.723(b)(3), 172.833(b)(4), 172.846(b), 172.858(a), 180.25(b),
and 180.30(a)). The current regulation for epoxidized soybean oil
(Sec. 172.723(b)(3)) includes a limit of 10 milligrams per kilogram
(mg/kg) for heavy metals (as lead (Pb)), as determined by Method II of
the ``Heavy Metals Test'' in FCC IV. FCC 7, however, does not include a
monograph for epoxidized soybean oil and does not include the ``Heavy
Metals Test'' as a general test in the appendices of FCC 7.
Accordingly, Sec. 172.723(b)(3) has been excluded from the petition.
U.S.P. has excluded the remaining five regulations (Sec. Sec.
172.833(b)(4), 172.846(b), 172.858(a), 180.25(b), and 180.30(a)) based
on its need to further investigate the bases for such updates.
The petitioner cited several reasons for updating the references to
older editions of the FCC to specifications and analytical
methodologies contained in FCC 7. First, previous editions of the FCC
are no longer readily available to industry or the public, since U.S.P.
does not maintain and therefore cannot provide copies of monographs
from FCC III, IV, or V to industry or the public. (Under 5 U.S.C.
552(a) and 1 CFR 51.7(a)(4), a publication that is to be incorporated
by reference must be ``reasonably available'' to and capable of being
used by persons affected by the publication.) Second, the petitioner
maintained that updating the references to older editions of the FCC to
FCC 7 may avoid confusion, inconsistency, and lack of uniformity in the
quality of food additives and ingredients manufactured and sold. Third,
the petitioner noted that, in many cases, the editions of the FCC prior
to FCC 7 may employ outdated analytical methodologies and equipment
that do not reflect current scientific practices, and which may be
difficult to obtain.
We note that, subsequent to our analysis of FCC 7, the U.S.P.
published the eighth edition of the FCC (FCC 8) in March 2012.
Initiating a review of FCC 8 at this time would delay issuance of this
final rule. To avoid a delay in updating the references to the FCC in
our food additive regulations, we are proceeding with issuing this
final rule to incorporate by reference FCC 7. The specific food
additive regulations explain how to obtain copies of FCC 7. As
appropriate, we will provide further updates to our food additive
regulations to reflect more recent versions of the FCC.
II. Evaluation of Amendments to Parts 172, 173, 178, and 180
We compared the specifications and analytical methods in the
versions of the FCC currently referenced in the regulations to the
specifications and analytical methods in FCC 7 (Ref. 1). In addition,
we note that some general changes were made to FCC monographs published
in or after FCC IV that remain in FCC 7. One change is that the older
FCC monographs discussed in this document that contain a specification
limit for heavy metals (as Pb) were updated in FCC V to remove this
specification, and, when appropriate, to replace it with an individual
specification limit for each relevant heavy metal. Many FCC 7
monographs have also adopted lower lead limit specifications compared
to earlier FCC editions, to reduce lead in food. Furthermore, if an
earlier edition of the FCC contained a specification limit for arsenic,
that specification has been removed unless the monograph met one of the
following criteria: (1) The ingredient or additive is a high-volume
consumption item (greater than 25 million pounds per year), (2) the
ingredient or additive is derived from a natural (mineral) source where
arsenic may be an intrinsic contaminant, and/or
[[Page 71459]]
(3) there is reason to believe that arsenic constitutes a significant
part of the total heavy metals content (Ref. 1).
An FCC monograph typically consists of a description of the
substance, its functional use, the recommended specifications for the
substance, and testing methodology. In many cases, there are minor
differences between the description or functional use of a substance
provided in FCC 7 compared to the description or functional use of a
substance provided in earlier editions of the FCC and the CFR. However,
FCC 7 provides the description and functional use of a substance
specified in a monograph for informational purposes, e.g., to help
industry understand the possible functions of the ingredients, rather
than as a required standard. Other differences (e.g., solvent or
instrument changes) between the specifications and analytical methods
in the version of the FCC currently referenced in the regulations and
the specifications and analytical methods in FCC 7 are discussed
further in the FDA Memoranda from D. Folmer to M. Honigfort (Refs. 1
through 3).
After review of each proposed amendment, we are updating the
regulations shown in table 1 to incorporate FCC 7 by reference. We note
that the safety of these additives has been previously considered and
there are no safety concerns with the proposed changes to incorporate
by reference the specifications and analytical methodologies contained
in FCC 7. We are also amending Sec. 178.1005 to incorporate by
reference the specifications for ``Acidity,'' ``Chloride'' and ``Other
requirements'' for Hydrogen Peroxide Concentrate in the United States
Pharmacopeia, 36th Revision (2013). This updates the reference to the
United States Pharmacopeia XX (1980) already cited in Sec. 178.1005.
We compared the United States Pharmacopeia XX (1980) monograph for
Hydrogen Peroxide Concentrate to the United States Pharmacopeia, 36th
Revision (2013) monograph for Hydrogen Peroxide Concentrate and
determined that this update is safe and appropriate (Ref. 4).
Table 1--List of Regulations
----------------------------------------------------------------------------------------------------------------
21 CFR Section Name of Additive FCC 7 Reference
----------------------------------------------------------------------------------------------------------------
172.167(b)............................ Hydrogen peroxide............. Meets FCC 7 specifications.
172.320(b)(1)......................... Amino acids................... Meets FCC 7 specifications.
172.345(b)............................ Folic acid (folacin).......... Meets FCC 7 specifications.
172.379(b)............................ Vitamin D2.................... Meets FCC 7 specifications.
172.380(b)............................ Vitamin D3.................... Meets FCC 7 specifications.
172.665(d)(2)......................... Gellan gum.................... Residual isopropyl alcohol limit not to
exceed 0.075% by the procedure
described in the Gellan Gum monograph
in FCC 7.
172.712(b)............................ 1,3-Butylene glycol........... Conforms to FCC 7 identity and
specifications.
172.736(b)(2)......................... Glycerides and polyglycides of Acid value not greater than 2, and
hydrogenated vegetable oils. hydroxyl value, not greater than 56 as
determined by ``Acid Value'' and
``Hydroxyl Value'' methods.
172.780(b)............................ Acacia (gum arabic)........... Meets FCC 7 specifications.
172.800(b)(2)......................... Acesulfame potassium.......... Fluoride content not more than 30
milligrams per kilogram (mg/kg) as
determined by Method III of the
Fluoride Limit Test (We have amended
the specification for fluoride content
in acesulfame potassium in Sec.
172.800(b)(2) to replace ``parts per
million'' with ``mg/kg'' to be
consistent with terminology used
elsewhere in the regulations cited in
this rule.).
172.804(b)............................ Aspartame..................... Meets FCC 7 specifications.
172.810............................... Dioctyl sodium sulfosuccinate. Meets FCC 7 specifications.
172.812(a)............................ Glycine....................... Meets FCC 7 specifications.
172.831(b)............................ Sucralose..................... Meets FCC 7 specifications.
172.841(b)............................ Polydextrose.................. Meets FCC 7 specifications.
172.862(b)(1)......................... Oleic acid derived from tall Meets FCC 7 specifications except that
oil fatty acids. titer (solidification point) shall not
exceed 13.5 degrees Celsius and
unsaponifiable matter shall not exceed
0.5%.
172.867(b)............................ Olestra....................... Meets FCC 7 specifications.
172.869(b)(6)......................... Sucrose oligoesters........... Acid value not more than 4.0 as
determined by the method ``Acid
Value,'' Appendix VII, Method I
(Commercial Fatty Acids).
172.869(b)(7)......................... Sucrose oligoesters........... Residue on ignition not more than 0.7%
as determined by ``Residue on
Ignition,'' Appendix IIC, Method I
(using a 1 gram sample).
172.869(b)(8)......................... Sucrose oligoesters........... Residual methanol not more than 10 mg/kg
as determined by the method listed in
the monograph for ``Sucrose Fatty Acid
Esters''.
172.869(b)(9)......................... Sucrose oligoesters........... Residual dimethyl sulfoxide not more
than 2.0 mg/kg as determined by the
method listed in the monograph
``Sucrose Fatty Acid Esters''.
172.869(b)(10)........................ Sucrose oligoesters........... Residual isobutyl alcohol not more than
10 mg/kg as determined by the method
listed in the monograph ``Sucrose Fatty
Acid Esters''.
172.869(b)(11)........................ Sucrose oligoesters........... Lead not more than 1.0 mg/kg as
determined by ``Atomic Absorption
Spectrophotometric Graphite Furnace
Method,'' Method I.
173.160(d)............................ Candida gulliermondii......... Citric acid produced must conform to FCC
7 specifications (under ``Citric
acid'').
173.165(d)............................ Candida lipolytica............ Citric acid produced must conform to FCC
7 specifications (under ``Citric
acid'').
173.228(a)............................ Ethyl acetate................. Meets FCC 7 specifications.
173.280(c)............................ Solvent extraction process for Citric acid produced must conform to FCC
citric acid. 7 specifications (under ``Citric
acid'').
[[Page 71460]]
173.310(c)............................ Boiler water additives; Sodium Contains not less than 95% sodium
carboxymethylcellulose. carboxymethylcellulose on a dry-weight
basis, with maximum substitution of 0.9
carboxymethylcellulose groups per
anhydroglucose unit, and with a minimum
viscosity of 15 centipoises for 2% by
weight aqueous determined by the
``Viscosity of Cellulose Gum'' method
cited in FCC 7.
173.310(c)............................ Boiler water additives; Polysorbate 20 present in sorbitol
Sorbitol anhydride esters. anhydride esters meets FCC 7
specifications (We have amended the
limitation for sorbitol anhydride
esters in Sec. 173.310(c) to replace
``parts per million'' with ``mg/kg'' to
be consistent with terminology used
elsewhere in the regulations cited in
this rule.).
173.368(c)............................ Ozone......................... Meets FCC 7 specifications.
178.1005(c)........................... Hydrogen peroxide solution.... Meets FCC 7 specifications (We are also
amending the regulation to incorporate
by reference the United States
Pharmacopeia, 36th Revision.).
180.37(b)............................. Saccharin, ammonium saccharin, Meets FCC 7 specifications.
calcium saccharin, and sodium
saccharin.
----------------------------------------------------------------------------------------------------------------
The petitioner also requested amending Sec. 173.115(b)(3) (Alpha-
acetolactate decarboxylase ([alpha]-ALDC) enzyme preparation derived
from a recombinant Bacillus subtilis). The current regulation requires
that the enzyme preparation should meet the general and additional
requirements for enzyme preparations found in FCC IV. FCC 7
specifically includes [alpha]-ALDC in the list of enzyme preparations,
but does not contain an assay method specific to [alpha]-ALDC. We are
not amending Sec. 173.115(b)(3) at this time to incorporate by
reference the specifications in FCC 7 because the assay method for
[alpha]-ALDC has been omitted from FCC 7.
Additionally, on our own initiative, we are amending certain
provisions in parts 172, 173, 178, and 180 to update the address at
which copies of FCC 7 can be examined. In most cases, the existing
regulations refer to an FDA address at ``5100 Paint Branch Pkwy.,
College Park, MD 20740.'' However, in 2013, we consolidated our library
holdings at our main library at 10903 New Hampshire Ave., Silver
Spring, MD 20993. Therefore, we are amending various provisions to
reflect the current FDA address at which copies of FCC 7 can be
examined.
III. Conclusion
We reviewed data in the petition and other relevant material and
conclude that the proposed amendments to the regulations listed in
table 1 to incorporate by reference food-grade specifications and
analytical methodologies from FCC 7, as discussed in Section II of this
document, are safe and appropriate. Therefore, we are amending parts
172, 173, 178, and 180 as set forth in this document.
IV. Public Availability of Documents
In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition
and the documents that we considered and relied upon in reaching our
decision to approve the petition will be made available for public
disclosure (see FOR FURTHER INFORMATION CONTACT). As provided in Sec.
171.1(h), we will delete from the documents any materials that are not
available for public disclosure.
V. Environmental Impact
Under part H in Sec. 171.1(c), either an environmental assessment
under 21 CFR 25.40 or a claim of categorical exclusion under Sec.
25.30 (21 CFR 25.30) or Sec. 25.32 (21 CFR 25.32) is required to be
submitted with a food additive petition. As initially filed by U.S.P.,
the petition contained a claim of categorical exclusion under Sec.
25.30(i), which applies to corrections and technical changes in
regulations. We reviewed the petitioner's claim of categorical
exclusion and stated in our original filing notice of August 10, 2010,
that we agreed that, under Sec. 25.30(i), the proposed action was of a
type that would not individually or cumulatively have a significant
effect on the human environment and therefore that neither an
environmental assessment nor an environmental impact statement would be
required.
However, upon further review, we decided that as a group, the
actions being requested are neither corrections nor technical changes
and therefore the categorical exclusion in Sec. 25.30(i) would not be
applicable. Accordingly we announced, in an amended filing notice
published in the Federal Register of January 18, 2012 (77 FR 2492),
that U.S.P. had submitted an environmental assessment for the petition
in lieu of a claim of categorical exclusion and that we would review
the potential environmental impact of the petition. We placed the
petitioner's environmental assessment on display in the Division of
Dockets Management for public review and comment.
We have carefully reviewed the environmental assessment and
considered the potential environmental effects of this action. We have
concluded that the action will not have a significant impact on the
human environment, and that an environmental impact statement is not
required. Our finding of no significant impact and the evidence
supporting that finding, contained in the environmental assessment, may
be seen in the Division of Dockets Management (see ADDRESSES) between 9
a.m. and 4 p.m., Monday through Friday.
VI. Paperwork Reduction Act of 1995
This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
VII. Objections
If you will be adversely affected by one or more provisions of this
regulation, you may file with the Division of Dockets Management (see
ADDRESSES) either electronic or written objections. You must separately
number each objection, and within each numbered objection you must
specify with particularity the provision(s) to which you object and the
grounds for your objection. Within each numbered objection, you must
specifically state whether you are requesting a hearing on the
particular provision that you specify in that numbered objection. If
you do not request a hearing for any particular objection, you waive
the right to a
[[Page 71461]]
hearing on that objection. If you request a hearing, your objection
must include a detailed description and analysis of the specific
factual information you intend to present in support of the objection
in the event that a hearing is held. If you do not include such a
description and analysis for any particular objection, you waive the
right to a hearing on the objection. It is only necessary to send one
set of documents. Identify documents with the docket number found in
brackets in the heading of this document. Any objections received in
response to the regulation may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday, and will
be posted to the docket at https://www.regulations.gov.
VIII. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act
Our review of this petition was limited to section 409 of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348).
This final rule is not a statement regarding compliance with other
sections of the FD&C Act. For example, the Food and Drug Administration
Amendments Act of 2007, which was signed into law on September 27,
2007, amended the FD&C Act to, among other things, add section 301(ll)
of the FD&C Act (21 U.S.C. 331(ll)). Section 301(ll) of the FD&C Act
prohibits the introduction or delivery for introduction into interstate
commerce of any food that contains a drug approved under section 505 of
the FD&C Act (21 U.S.C. 355), a biological product licensed under
section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug
or biological product for which substantial clinical investigations
have been instituted and their existence has been made public, unless
one of the exceptions in section 301(ll)(1) to (ll)(4) of the FD&C Act
applies. In our review of this petition, we did not consider whether
section 301(ll) of the FD&C Act or any of its exemptions apply to food
containing these additives. Accordingly, this final rule should not be
construed to be a statement that a food containing these additives, if
introduced or delivered for introduction into interstate commerce,
would not violate section 301(ll) of the FD&C Act. Furthermore, this
language is included in all food additive final rules and therefore
should not be construed to be a statement of the likelihood that
section 301(ll) of the FD&C Act applies.
IX. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at https://www.regulations.gov.
1. FDA Memorandum from D. Folmer to M. Honigfort, October 24,
2011.
2. FDA Memorandum from D. Folmer to M. Honigfort, February 8,
2013.
3. FDA Memorandum from D. Folmer to M. Honigfort, February 27,
2013.
4. FDA Memorandum from D. Folmer to M. Honigfort, October 31,
2013.
List of Subjects
21 CFR Part 172
Food additives, Incorporation by reference, Reporting and
recordkeeping requirements.
21 CFR Part 173
Food additives, Incorporation by reference.
21 CFR Part 178
Food additives, Food packaging, Incorporation by reference.
21 CFR Part 180
Food additives, Incorporation by reference.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Director, Center for Food Safety and Applied
Nutrition, 21 CFR parts 172, 173, 178, and 180 are amended as follows:
PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR
HUMAN CONSUMPTION
0
1. The authority citation for 21 CFR part 172 continues to read as
follows:
Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.
0
2. Amend Sec. 172.167 by revising paragraph (b) to read as follows:
Sec. 172.167 Silver nitrate and hydrogen peroxide solution.
* * * * *
(b) Hydrogen peroxide meets the specifications of the Food
Chemicals Codex, 7th ed. (2010), pp. 496-497, which is incorporated by
reference. The Director of the Office of the Federal Register approves
this incorporation by reference in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. You may obtain copies from the United States
Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852
(Internet address https://www.usp.org). Copies may be examined at the
Food and Drug Administration's Main Library, 10903 New Hampshire Ave.,
Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030 or go to:
https://www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
0
3. Revise Sec. 172.320 to read as follows:
Sec. 172.320 Amino acids.
The food additive amino acids may be safely used as nutrients added
to foods in accordance with the following conditions:
(a) The food additive consists of one or more of the following
individual amino acids in the free, hydrated, or anhydrous form, or as
the hydrochloride, sodium, or potassium salts:
(1) L-Alanine
(2) L-Arginine
(3) L-Asparagine
(4) L-Aspartic acid
(5) L-Cysteine
(6) L-Cystine
(7) L-Glutamic acid
(8) L-Glutamine
(9) Aminoacetic acid (glycine)
(10) L-Histidine
(11) L-Isoleucine
(12) L-Leucine
(13) L-Lysine
(14) DL-Methionine (not for infant foods)
(15) L-Methionine
(16) L-Phenylalanine
(17) L-Proline
(18) L-Serine
(19) L-Threonine
(20) L-Tryptophan
(21) L-Tyrosine
(22) L-Valine
(b) The food additive meets the following specifications:
(1) As found in Food Chemicals Codex:
(i) L-Alanine, pages 28 and 29.
(ii) L-Arginine, pages 69 and 70.
(iii) L-Arginine Monohydrochloride, pages 70 and 71.
(iv) L-Cysteine Monohydrochloride, pages 269 and 270.
(v) L-Cystine, pages 270 and 271.
(vi) Aminoacetic acid (glycine), pages 457 and 458.
(vii) L-Leucine, pages 577 and 578.
(viii) DL-Methionine, pages 641 and 642.
(ix) L-Methionine, pages 642 and 643.
(x) L-Tryptophan, pages 1060 and 1061.
(xi) L-Phenylalanine, pages 794 and 795.
(xii) L-Proline, pages 864 and 865.
(xiii) L-Serine, pages 915 and 916.
[[Page 71462]]
(xiv) L-Threonine, pages 1031 and 1032.
(xv) L-Glutamic Acid Hydrochloride, page 440.
(xvi) L-Isoleucine, pages 544 and 545.
(xvii) L-Lysine Monohydrochloride, pages 598 and 599.
(xviii) Monopotassium L-glutamate, pages 697 and 698.
(xix) L-Tyrosine, page 1061.
(xx) L-Valine, pages 1072.
(2) As found in ``Specifications and Criteria for Biochemical
Compounds,'' NAS/NRC Publication, for the following:
(i) L-Asparagine
(ii) L-Aspartic acid
(iii) L-Glutamine
(iv) L-Histidine
(c) The additive(s) is used or intended for use to significantly
improve the biological quality of the total protein in a food
containing naturally occurring primarily intact protein that is
considered a significant dietary protein source, provided that:
(1) A reasonable daily adult intake of the finished food furnishes
at least 6.5 grams of naturally occurring primarily intact protein
(based upon 10 percent of the daily allowance for the ``reference''
adult male recommended by the National Academy of Sciences in
``Recommended Dietary Allowances,'' NAS Publication No. 1694.
(2) The additive(s) results in a protein efficiency ratio (PER) of
protein in the finished ready-to-eat food equivalent to casein as
determined by the method specified in paragraph (d) of this section.
(3) Each amino acid (or combination of the minimum number necessary
to achieve a statistically significant increase) added results in a
statistically significant increase in the PER as determined by the
method described in paragraph (d) of this section. The minimum amount
of the amino acid(s) to achieve the desired effect must be used and the
increase in PER over the primarily intact naturally occurring protein
in the food must be substantiated as a statistically significant
difference with at least a probability (P) value of less than 0.05.
(4) The amount of the additive added for nutritive purposes plus
the amount naturally present in free and combined (as protein) form
does not exceed the following levels of amino acids expressed as
percent by weight of the total protein of the finished food:
------------------------------------------------------------------------
Percent by weight of total
protein (expressed as free
amino acid)
------------------------------------------------------------------------
L-Alanine................................. 6.1
L-Arginine................................ 6.6
L-Aspartic acid (including L-asparagine).. 7.0
L-Cystine (including L-cysteine).......... 2.3
L-Glutamic acid (including L-glutamine)... 12.4
Aminoacetic acid (glycine)................ 3.5
L-Histidine............................... 2.4
L-Isoleucine.............................. 6.6
L-Leucine................................. 8.8
L-Lysine.................................. 6.4
L- and DL-Methionine...................... 3.1
L-Phenylalanine........................... 5.8
L-Proline................................. 4.2
L-Serine.................................. 8.4
L-Threonine............................... 5.0
L-Tryptophan.............................. 1.6
L-Tyrosine................................ 4.3
L-Valine.................................. 7.4
------------------------------------------------------------------------
(d) Compliance with the limitations concerning PER under paragraph
(c) of this section shall be determined by the method described in
sections 43.212-43.216, ``Official Methods of Analysis of the
Association of Official Analytical Chemists.'' Each manufacturer or
person employing the additive(s) under the provisions of this section
shall keep and maintain throughout the period of his use of the
additive(s) and for a minimum of 3 years thereafter, records of the
tests required by this paragraph and other records required to assure
effectiveness and compliance with this regulation and shall make such
records available upon request at all reasonable hours by any officer
or employee of the Food and Drug Administration, or any other officer
or employee acting on behalf of the Secretary of Health and Human
Services and shall permit such officer or employee to conduct such
inventories of raw and finished materials on hand as he deems necessary
and otherwise to check the correctness of such records.
(e) To assure safe use of the additive, the label and labeling of
the additive and any premix thereof shall bear, in addition to the
other information required by the Act, the following:
(1) The name of the amino acid(s) contained therein including the
specific optical and chemical form.
(2) The amounts of each amino acid contained in any mixture.
(3) Adequate directions for use to provide a finished food meeting
the limitations prescribed by paragraph (c) of this section.
(f) The food additive amino acids added as nutrients to special
dietary foods that are intended for use solely under medical
supervision to meet nutritional requirements in specific medical
conditions and comply with the requirements of part 105 of this chapter
are exempt from the limitations in paragraphs (c) and (d) of this
section and may be used in such foods at levels not to exceed good
manufacturing practices.
(g) The standards required in this section are incorporated by
reference into this section with the approval of the Director of the
Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be
examined at the Food and Drug Administration's Main Library, 10903 New
Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-
2039, or at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030 or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.
(1) AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500,
Gaithersburg, MD 20877:
(i) Sections 43.212-43.216, ``Official Methods of Analysis of the
Association
[[Page 71463]]
of Official Analytical Chemists,'' 13th Ed. (1980).
(ii) [Reserved].
(2) National Academy of Sciences, available from the FDA Main
Library, 10903 New Hampshire Ave., Silver Spring, MD 20993:
(i) ``Recommended Dietary Allowances,'' NAS Publication No. 1694,
7th Ed. (1968).
(ii) ``Specifications and Criteria for Biochemical Compounds,''
NAS/NRC Publication, 3rd Ed. (1972).
(3) United States Pharmacopeial Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address https://www.usp.org):
(i) Food Chemicals Codex, 7th ed. (2010), pages 28, 29, 69, 70, 71,
269, 270, 271, 440, 457, 458, 544, 545, 577, 578, 598, 599, 641, 642,
643, 697, 698, 794, 795, 864, 865, 915, 916, 1031, 1032, 1060, 1061,
and 1072.
(ii) [Reserved].
0
4. Amend Sec. 172.345 by revising paragraph (b) to read as follows:
Sec. 172.345 Folic acid (folacin).
* * * * *
(b) Folic acid meets the specifications of the Food Chemicals
Codex, 7th ed. (2010), pp. 406-407, which is incorporated by reference.
The Director of the Office of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may obtain copies from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet
address https://www.usp.org). Copies may be examined at the Food and
Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2,
Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202-741-6030 or go to:
https://www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
0
5. Amend Sec. 172.379 by revising paragraph (b) to read as follows:
Sec. 172.379 Vitamin D2.
* * * * *
(b) Vitamin D2 meets the specifications of the Food
Chemicals Codex, 7th ed. (2010), pp. 1080-1081, which is incorporated
by reference. The Director of the Office of the Federal Register
approves this incorporation by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may obtain copies from the United States
Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852
(Internet address https://www.usp.org). Copies may be examined at the
Food and Drug Administration's Main Library, 10903 New Hampshire Ave.,
Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030 or go to:
https://www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
0
6. Amend Sec. 172.380 by revising paragraph (b) to read as follows:
Sec. 172.380 Vitamin D3.
* * * * *
(b) Vitamin D3 meets the specifications of the Food
Chemicals Codex, 7th ed. (2010), pp. 1081-1082, which is incorporated
by reference. The Director of the Office of the Federal Register
approves this incorporation by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may obtain copies from the United States
Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852
(Internet address https://www.usp.org). Copies may be examined at the
Food and Drug Administration's Main Library, 10903 New Hampshire Ave.,
Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030 or go to:
https://www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
0
7. Amend Sec. 172.665 by revising paragraph (d)(2) to read as follows:
Sec. 172.665 Gellan gum.
* * * * *
(d) * * *
(2) Residual isopropyl alcohol (IPA) not to exceed 0.075 percent as
determined by the procedure described in the ``Gellan gum'' monograph
in the Food Chemicals Codex, 7th ed. (2010), pp. 425-426, which is
incorporated by reference. The Director of the Office of the Federal
Register approves this incorporation by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United
States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD
20852 (Internet address https://www.usp.org). Copies may be examined at
the Food and Drug Administration's Main Library, 10903 New Hampshire
Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030 or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
0
8. Amend Sec. 172.712 by revising paragraph (b) to read as follows:
Sec. 172.712 1,3-Butylene glycol.
* * * * *
(b) The food additive shall conform to the identity and
specifications of the Food Chemicals Codex, 7th ed. (2010), p. 126,
which is incorporated by reference. The Director of the Office of the
Federal Register approves this incorporation by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the
United States Pharmacopeial Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address https://www.usp.org). Copies may
be examined at the Food and Drug Administration's Main Library, 10903
New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-
796-2039, or at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
call 202-741-6030 or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
0
9. Amend Sec. 172.736 by revising paragraph (b)(2) to read as follows:
Sec. 172.736 Glycerides and polyglycides of hydrogenated vegetable
oils.
* * * * *
(b) * * *
(2) Acid value, not greater than 2, and hydroxyl value, not greater
than 56, as determined by the methods entitled ``Acid Value,'' p. 1220
and ``Hydroxyl Value,'' p. 1223, respectively, in the Food Chemicals
Codex, 7th ed. (2010), which is incorporated by reference. The Director
of the Office of the Federal Register approves this incorporation by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may
obtain copies from the United States Pharmacopeial Convention, 12601
Twinbrook Pkwy., Rockville, MD 20852 (Internet address https://www.usp.org). Copies may be examined at the Food and Drug
Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third
Floor, Silver Spring, MD 20993, 301-796-2039, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202-741-6030 or go to:
https://
[[Page 71464]]
www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
0
10. Amend Sec. 172.780 by revising paragraph (b) to read as follows:
Sec. 172.780 Acacia (gum arabic).
* * * * *
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 7th ed. (2010), p. 460, which is incorporated by reference. The
Director of the Office of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may obtain copies from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet
address https://www.usp.org). Copies may be examined at the Food and
Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2,
Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202-741-6030 or go to:
https://www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
0
11. Amend Sec. 172.800 by revising paragraph (b)(2) to read as
follows:
Sec. 172.800 Acesulfame potassium.
* * * * *
(b) * * *
(2) Fluoride content is not more than 30 milligrams per kilogram,
as determined by method III of the Fluoride Limit Test of the Food
Chemicals Codex, 7th ed. (2010), p. 1151, which is incorporated by
reference. The Director of the Office of the Federal Register approves
this incorporation by reference in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. You may obtain copies from the United States
Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852
(Internet address https://www.usp.org). Copies may be examined at the
Food and Drug Administration's Main Library, 10903 New Hampshire Ave.,
Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030 or go to:
https://www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
0
12. Amend Sec. 172.804 by revising paragraph (b) to read as follows:
Sec. 172.804 Aspartame.
* * * * *
(b) The additive meets the specifications of the Food Chemicals
Codex, 7th ed. (2010), pp. 73-74, which is incorporated by reference.
The Director of the Office of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may obtain copies from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet
address https://www.usp.org). Copies may be examined at the Food and
Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2,
Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202-741-6030 or go to:
https://www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
0
13. Revise the introductory text of Sec. 172.810 to read as follows:
Sec. 172.810 Dioctyl sodium sulfosuccinate.
The food additive, dioctyl sodium sulfosuccinate, meets the
specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 313-
314, which is incorporated by reference. The Director of the Office of
the Federal Register approves this incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain
copies from the United States Pharmacopeial Convention, 12601 Twinbrook
Pkwy., Rockville, MD 20852 (Internet address https://www.usp.org).
Copies may be examined at the Food and Drug Administration's Main
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring,
MD 20993, 301-796-2039, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030 or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html). The food additive, dioctyl
sodium sulfosuccinate, may be safely used in food in accordance with
the following prescribed conditions:
* * * * *
0
14. Amend Sec. 172.812 by revising paragraph (a) to read as follows:
Sec. 172.812 Glycine.
* * * * *
(a) The additive meets the specifications of the Food Chemicals
Codex, 7th ed. (2010), pp. 457-458, which is incorporated by reference.
The Director of the Office of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may obtain copies from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet
address https://www.usp.org). Copies may be examined at the Food and
Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2,
Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202-741-6030 or go to:
https://www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
0
15. Amend Sec. 172.831 by revising paragraph (b) to read as follows:
Sec. 172.831 Sucralose.
* * * * *
(b) The additive meets the specifications of the Food Chemicals
Codex, 7th ed. (2010), pp. 993-995, which is incorporated by reference.
The Director of the Office of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may obtain copies from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet
address https://www.usp.org). Copies may be examined at the Food and
Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2,
Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202-741-6030 or go to:
https://www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
0
16. Amend Sec. 172.841 by revising paragraph (b) to read as follows:
Sec. 172.841 Polydextrose.
* * * * *
(b) The additive meets the specifications of the Food Chemicals
Codex, 7th ed. (2010), pp. 811-814, which is incorporated by reference.
The Director of the Office of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may obtain copies from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet
address https://www.usp.org). Copies may be examined at the Food and
Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2,
Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National
[[Page 71465]]
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202-741-6030 or go to:
https://www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
0
17. Amend Sec. 172.862 by revising paragraph (b)(1) to read as
follows:
Sec. 172.862 Oleic acid derived from tall oil fatty acids.
* * * * *
(b) * * *
(1) Specifications for oleic acid prescribed in the Food Chemicals
Codex, 7th ed. (2010), pp. 743-744, which is incorporated by reference,
except that titer (solidification point) shall not exceed 13.5 [deg]C
and unsaponifiable matter shall not exceed 0.5 percent. The Director of
the Office of the Federal Register approves this incorporation by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may
obtain copies from the United States Pharmacopeial Convention, 12601
Twinbrook Pkwy., Rockville, MD 20852 (Internet address https://www.usp.org). Copies may be examined at the Food and Drug
Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third
Floor, Silver Spring, MD 20993, 301-796-2039, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202-741-6030 or go to:
https://www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
0
18. Amend Sec. 172.867 by revising paragraph (b) to read as follows:
Sec. 172.867 Olestra.
* * * * *
(b) Olestra meets the specifications of the Food Chemicals Codex,
7th ed. (2010), pp. 744-746, which is incorporated by reference. The
Director of the Office of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may obtain copies from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet
address https://www.usp.org). Copies may be examined at the Food and
Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2,
Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202-741-6030 or go to:
https://www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
0
19. Amend Sec. 172.869 by revising paragraph (b) introductory text and
paragraphs (b)(6) through (b)(11) to read as follows:
Sec. 172.869 Sucrose oligoesters.
* * * * *
(b) Sucrose oligoesters meet the specifications in the methods
listed in the table in this paragraph. The methods for determining
compliance with each specification are incorporated by reference. The
Director of the Office of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies may be examined at the Food and Drug Administration's
Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver
Spring, MD 20993, 301-796-2039, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030 or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html. Copies of the methods are
available from the sources listed in the table in this paragraph:
----------------------------------------------------------------------------------------------------------------
Source for
Specification Limit Method cited obtaining method
----------------------------------------------------------------------------------------------
* * * * * * *
(6) Acid Value.................. Not more than 4.0.. ``Acid Value,'' United States
Appendix VII, Pharmacopeial
Method I Convention, 12601
(Commercial Fatty Twinbrook Pkwy.,
Acids), in the Rockville, MD
Food Chemicals 20852 (Internet
Codex, 7th ed. address https://
(2010), p. 1220.. www.usp.org)
(7) Residue on Ignition......... Not more than 0.7%. ``Residue on Do.
Ignition,''
Appendix IIC,
Method I, in the
Food Chemicals
Codex, 7th ed.
(2010), pp. 1141-
1142 (using a 1-
gram sample)..
(8) Residual Methanol........... Not more than 10 Method listed in Do
milligrams/ the monograph for
kilogram. ``Sucrose Fatty
Acid Esters'' in
the Food Chemicals
Codex, 7th ed.
(2010), pp. 998-
1000..
(9) Residual Dimethyl Sulfoxide. Not more than 2.0 ......do........... Do.
milligrams/
kilogram.
(10) Residual Isobutyl Alcohol.. Not more than 10 ......do........... Do.
milligrams/
kilogram.
(11) Lead....................... Not more than 1.0 ``Atomic Absorption Do.
milligram/kilogram. Spectrophometric
Graphite Furnace
Method,'' Method I
in the Food
Chemicals Codex,
7th ed. (2010), p.
1154-1155.
----------------------------------------------------------------------------------------------------------------
[[Page 71466]]
* * * * *
PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR
HUMAN CONSUMPTION
0
20. The authority citation for 21 CFR part 173 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348.
0
21. Amend Sec. 173.160 by revising paragraph (d) to read as follows:
Sec. 173.160 Candida guilliermondii.
* * * * *
(d) The additive is so used that the citric acid produced conforms
to the specifications of the Food Chemicals Codex, 7th ed. (2010), pp.
226-227, which is incorporated by reference. The Director of the Office
of the Federal Register approves this incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain
copies from the United States Pharmacopeial Convention, 12601 Twinbrook
Pkwy., Rockville, MD 20852 (Internet address https://www.usp.org).
Copies may be examined at the Food and Drug Administration's Main
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring,
MD 20993, 301-796-2039, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030 or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.
0
22. Amend Sec. 173.165 by removing the first three sentences in
paragraph (d) and adding five sentences in their place to read as
follows:
Sec. 173.165 Candida lipolytica.
* * * * *
(d) The additive is so used that the citric acid produced conforms
to the specifications of the Food Chemicals Codex, 7th ed. (2010), pp.
226-227, which is incorporated by reference. The Director of the Office
of the Federal Register approves this incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain
copies from the United States Pharmacopeial Convention, 12601 Twinbrook
Pkwy., Rockville, MD 20852 (Internet address https://www.usp.org).
Copies may be examined at the Food and Drug Administration's Main
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring,
MD 20993, 301-796-2039, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030 or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html. * * *
* * * * *
0
23. Amend Sec. 173.228 by revising paragraph (a) and removing footnote
1 to read as follows:
Sec. 173.228 Ethyl acetate.
* * * * *
(a) The additive meets the specifications of the Food Chemicals
Codex, 7th ed. (2010), pp. 343-344, which is incorporated by reference.
The Director of the Office of the Federal Register approves this
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may obtain copies from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet
address https://www.usp.org). Copies may be examined at the Food and
Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2,
Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202-741-6030 or go to:
https://www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
0
24. Amend Sec. 173.280 by revising paragraph (c) to read as follows:
Sec. 173.280 Solvent extraction process for citric acid.
* * * * *
(c) The citric acid so produced meets the polynuclear aromatic
hydrocarbon specifications of Sec. 173.165 and the specifications of
the Food Chemicals Codex, 7th ed. (2010), pp. 226-227, which is
incorporated by reference. The Director of the Office of the Federal
Register approves this incorporation by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United
States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD
20852 (Internet address https://www.usp.org). Copies may be examined at
the Food and Drug Administration's Main Library, 10903 New Hampshire
Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030 or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
0
25. Amend Sec. 173.310 in the table in paragraph (c) by revising the
entries for ``Acrylic acid/2-acrylamido-2-methyl propane sulfonic acid
copolymer'', ``Sodium carboxymethylcellulose'', and ``Sorbitol
anhydride esters'' and add paragraph (f) to read as follows:
Sec. 173.310 Boiler water additives.
* * * * *
(c) List of substances:
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
* * * * * * *
Acrylic acid/2-acrylamido-2-methyl Total not to exceed 20 parts
propane sulfonic acid copolymer having per million (active) in boiler
a minimum weight average molecular feedwater.
weight of 9,900 and a minimum number
average molecular weight of 5,700 as
determined by a method entitled
``Determination of Weight Average and
Number Average Molecular Weight of 60/
40 AA/AMPS''.
* * * * * * *
Sodium carboxymethylcellulose.......... Contains not less than 95
percent sodium
carboxymethylcellulose on a
dry-weight basis, with maximum
substitution of 0.9
carboxymethylcellulose groups
per anhydroglucose unit, and
with a minimum viscosity of 15
centipoises for 2 percent by
weight aqueous solution at 25
[deg]C; by the ``Viscosity of
Cellulose Gum'' method
prescribed in the Food
Chemicals Codex, pp. 1128-
1129.
[[Page 71467]]
* * * * * * *
Sorbitol anhydride esters: A mixture The mixture is used as an
consisting of sorbitan monostearate as anticorrosive agent in steam
defined in Sec. 172. 842 of this boiler distribution systems,
chapter; polysorbate 60 with each component not to
((polyoxyethylene (20) sorbitan exceed 15 milligrams per
monostearate)) as defined in Sec. kilogram in the steam.
172.836 of this chapter; and
polysorbate 20 ((polyoxyethylene (20)
sorbitan monolaurate)), meeting the
specifications of the Food Chemicals
Codex, pp. 825-827..
* * * * * * *
------------------------------------------------------------------------
* * * * *
(f) The standards required in this section are incorporated by
reference into this section with the approval of the Director of the
Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be
examined at the Food and Drug Administration's Main Library, 10903 New
Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-
2039, or at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030 or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.
(1) FDA Main Library, 10903 New Hampshire Ave., Silver Spring, MD
20993:
(i) ``Determination of Weight Average and Number Average Molecular
Weight of 60/40 AA/AMPS'' (October 23, 1987).
(ii) [Reserved].
(2) United States Pharmacopeial Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address https://www.usp.org):
(i) Food Chemicals Codex, 7th ed. (2010), pp. 1128-1129.
(ii) Food Chemicals Codex, 7th ed. (2010), pp. 825-827.
0
26. Amend Sec. 173.368 by revising paragraph (c) to read as follows:
Sec. 173.368 Ozone.
* * * * *
(c) The additive meets the specifications for ozone in the Food
Chemicals Codex, 7th ed. (2010), pp. 754-755, which is incorporated by
reference. The Director of the Office of the Federal Register approves
this incorporation by reference in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. You may obtain copies from the United States
Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852
(Internet address https://www.usp.org). Copies may be examined at the
Food and Drug Administration's Main Library, 10903 New Hampshire Ave.,
Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030 or go to:
https://www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND
SANITIZERS
0
27. The authority citation for 21 CFR part 178 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348, 379e.
0
28. Amend Sec. 178.1005 by revising paragraph (c) to read as follows:
Sec. 178.1005 Hydrogen peroxide solution.
* * * * *
(c) Specifications. Hydrogen peroxide solution shall meet the
specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 496-
497, which is incorporated by reference. Hydrogen peroxide solution
shall also meet the specifications for ``Acidity,'' ``Chloride,'' and
``Other requirements'' for Hydrogen Peroxide Concentrate in the United
States Pharmacopeia 36th Revision (2013), pp. 3848-3849, which is
incorporated by reference. The Director of the Office of the Federal
Register approves this incorporation by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United
States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD
20852 (Internet address https://www.usp.org). Copies may be examined at
the Food and Drug Administration's Main Library, 10903 New Hampshire
Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030 or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
PART 180--FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD
ON AN INTERIM BASIS PENDING ADDITIONAL STUDY
0
29. The authority citation for 21 CFR part 180 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 343, 348, 371; 42 U.S.C. 241.
0
30. Amend Sec. 180.37 by revising paragraph (b) to read as follows:
Sec. 180.37 Saccharin, ammonium saccharin, calcium saccharin, and
sodium saccharin.
* * * * *
(b) The food additives meet the specifications of the Food
Chemicals Codex, 7th ed. (2010), pp. 52-54, 153-154, 898-899, 961-962,
which is incorporated by reference. The Director of the Office of the
Federal Register approves this incorporation by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the
United States Pharmacopeial Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address https://www.usp.org). Copies may
be examined at the Food and Drug Administration's Main Library, 10903
New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-
796-2039, or at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
call 202-741-6030 or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
Dated: November 21, 2013.
Susan M. Bernard,
Director, Office of Regulations, Policy and Social Sciences, Center for
Food Safety and Applied Nutrition.
[FR Doc. 2013-28439 Filed 11-27-13; 8:45 am]
BILLING CODE 4160-01-P
