[Federal Register Volume 78, Number 230 (Friday, November 29, 2013)]
[Rules and Regulations]
[Pages 71457-71467]
[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.

    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,<PHONE_NUMBER>.

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

(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'').

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

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,<PHONE_NUMBER>, or at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call<PHONE_NUMBER> 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.

(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

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,<PHONE_NUMBER>, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER> 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,<PHONE_NUMBER>, or at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call<PHONE_NUMBER> 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,<PHONE_NUMBER>, or at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call<PHONE_NUMBER> 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,<PHONE_NUMBER>, 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<PHONE_NUMBER> 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,<PHONE_NUMBER>, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER> or go to:
http://

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,<PHONE_NUMBER>, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER> 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,<PHONE_NUMBER>, or at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call<PHONE_NUMBER> 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,<PHONE_NUMBER>, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER> 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,<PHONE_NUMBER>, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER> 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,<PHONE_NUMBER>, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER> 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,<PHONE_NUMBER>, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER> 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,<PHONE_NUMBER>, or at the National

Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER> 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,<PHONE_NUMBER>, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER> 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,<PHONE_NUMBER>, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER> 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,<PHONE_NUMBER>, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER> 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.
----------------------------------------------------------------------------------------------------------------

* * * * *

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,<PHONE_NUMBER>, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER> 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,<PHONE_NUMBER>, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER> 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,<PHONE_NUMBER>, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER> 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,<PHONE_NUMBER>, 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.

                              * * * * * * *
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,<PHONE_NUMBER>, or at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call<PHONE_NUMBER> 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,<PHONE_NUMBER>, 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<PHONE_NUMBER> 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


[Federal Register: April 18, 2008 (Volume 73, Number 76)]
[Notices]
[Page 21167-21168]
[DOCID:fr18ap08-107]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Not Re-Evaluate Aircraft Kits Previously
Determined To Be Eligible for Certification as Amateur-Built Aircraft

AGENCY: Federal Aviation Administration (FAA), DOT.
SUMMARY: This notice announces the FAA's intent to not re-evaluate
aircraft kits previously determined to be eligible for certification as
amateur-built aircraft. Although the FAA recently announced its intent
to temporarily suspend amateur-built aircraft kit evaluations, this
notice announces our intent to not re-evaluate or remove any kits from
the agency's current eligibility list as a result of developing new
evaluation procedures. Those evaluations were conducted to determine if
a prefabricated amateur-built aircraft kit is eligible for
certification as an amateur-built aircraft and will continue to remain
valid.

FOR FURTHER INFORMATION CONTACT: Frank P. Paskiewicz, Manager,
Production and Airworthiness Division, Aircraft Certification Service,
AIR-200, Federal Aviation Administration, 800 Independence Ave., SW.,
Washington, DC 20591; telephone number:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    On February 15, 2008, the FAA published a notice in the Federal

Register (73 FR 8926) which temporarily suspended amateur-built
aircraft kit evaluations. The FAA has performed these evaluations as a
courtesy to assist manufacturers in determining whether their
prefabricated aircraft kits can meet the regulatory requirements for
certification as an amateur-built aircraft under the provisions of
Title 14, Code of Federal Regulations (14 CFR) 21.191(g). That section
defines an amateur-built aircraft as, ``an aircraft the major portion
of which has been fabricated and assembled by persons who undertook the
construction project solely for their own education or recreation.''
Upon determination that the percentage of a kit presented for
evaluation by a manufacturer permits the major portion (51%) of the
aircraft's fabrication and assembly to be completed by an amateur
builder, the aircraft kit is added to a list of eligible kits
maintained by the FAA.
    Kit evaluations have been a courtesy that the FAA has provided for
the convenience of kit manufacturers, their customers, and FAA
inspectors. Successful evaluations assure manufacturers that their kits
can be marketed as being eligible for certification as an amateur-built
aircraft. They also assist inspectors by providing a baseline from
which an inspector can begin an assessment of a completed aircraft kit
once it has been presented for certification under Sec.  21.191(g).
Additionally, the evaluations inform prospective applicants that an
aircraft is eligible for certification as an amateur-built aircraft,
when completed in accordance with FAA-evaluated assembly and
instruction manuals. Completion of a kit evaluation, however, is not,
nor ever has been, a regulatory requirement.
    The FAA recently concluded that a temporary suspension of kit
evaluations is necessary because existing policy and guidance used to
evaluate these kits has resulted in inconsistent determinations
regarding regulatory compliance. This decision also reflects the
conclusions of the Amateur-Built Aviation Rulemaking Committee (ARC).
That committee was established on July 26, 2006, to make
recommendations regarding the use of builder or commercial assistance
when fabricating and assembling amateur-built aircraft intended for
certification under Sec.  21.191(g). The committee concluded that the
process used for the evaluation of aircraft kits is not standardized.
The FAA believes a temporary suspension of kit evaluations is therefore
needed to update the policy and guidance material used to conduct these
evaluations. The agency is currently evaluating proposed changes to the
policy and guidance used to evaluate amateur-built aircraft kits.
    Since publication of the notice of the agency's temporary
suspension of kit evaluations in the Federal Register, amateur-built
aircraft kit manufacturers have expressed concerns that the FAA would
re-evaluate or remove kits on the current eligibility list as a result
of re-evaluating previously evaluated kits using the new evaluation
procedures. The FAA does not intend to re-evaluate or remove any of the
kits from the current eligibility list as a result of developing new
evaluation procedures. As is current practice, a re-evaluation of any
kit on the current eligibility list would only occur if a potentially
unsafe condition is identified. The temporary suspension of kit
evaluations does not affect the status of kits previously determined to
be eligible for certification as an amateur-built aircraft. Previous
FAA-conducted amateur-built aircraft kit evaluations remain valid.
    The FAA has also received inquiries concerning whether amateur-
built kit manufacturers may continue to develop, manufacture, market,
and sell their previously evaluated aircraft kits during the temporary
suspension. The FAA does not certify aircraft kits or approve kit
manufacturers. Kit evaluations are not required by the regulations and
do not prevent a manufacturer from introducing a new kit for the
amateur-built marketplace. Companies may continue to design, develop,
manufacture, market, and sell aircraft kits. The temporary suspension
in no way prevents these actions.
    Several amateur aircraft builders were also concerned that aircraft
currently being built from kits which were on the eligibility list at
their time of purchase would be reevaluated in accordance with new
procedures when the aircraft are presented for airworthiness
certification: The FAA will not re-evaluate these kit aircraft to the
new criteria when they are inspected for airworthiness certification
provided the kit from which they have been built remains on the current
list. The airworthiness certification process for these aircraft
remains unchanged. The determination that an applicant has fabricated
and assembled the major portion of an aircraft in accordance with Sec.
21.191(g), will continue to be accomplished when the aircraft is
inspected for airworthiness certification. This procedure is consistent
with longstanding practices in place prior to the temporary suspension
of kit evaluations.
    The FAA will resume amateur-built kit evaluations after issuing the
final policy changes. Prior to publishing the final policy, FAA will
solicit comments on draft procedures (FAA Orders and Advisory
Circulars) through a notice in the Federal Register.

    Issued in Washington, DC on April 8, 2008.
Frank Paskiewicz,
Manager, Production and Airworthiness Division.
 [FR Doc. E8-8217 Filed 4-17-08; 8:45 am]

BILLING CODE 4910-13-M