Document ID: FDA-2010-F-0320-0003
Agency: fda
Document Type: Rule
Title: Food Additive Regulations; Incorporation by Reference of the Food Chemicals Codex, 7th Edition
Posted Date: 2013-11-29T05:00Z

[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]

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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.

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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: http://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 http://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 http://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 http://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 http://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 http://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: 
http://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: http://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 http://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 http://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: 
http://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 http://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: 
http://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 http://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: 
http://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 http://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: http://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 http://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: http://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 http://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: 
http://

[[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 http://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: 
http://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 http://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: 
http://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 http://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: 
http://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 http://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: http://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 http://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: 
http://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 http://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: 
http://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 http://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: 
http://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 http://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: 
http://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 http://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: 
http://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: http://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 http://
                                                        (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 http://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: http://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 http://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: http://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 http://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: 
http://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 http://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: http://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: http://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 http://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 http://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: 
http://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 http://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: http://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 http://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: http://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