[Federal Register Volume 75, Number 153 (Tuesday, August 10, 2010)]
[Notices]
[Pages 48353-48355]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19722]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-F-0320]


United States Pharmacopeial Convention; Filing of Food Additive 
Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
U.S. Pharmacopeial Convention has filed a petition proposing that the 
food additive regulations that incorporate by reference food-grade 
specifications from prior editions of the Food Chemicals Codex (FCC) be 
amended to incorporate by reference food-grade specifications from the 
FCC, 7th Edition.

FOR FURTHER INFORMATION CONTACT: Mical E. Honigfort, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1278.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a 
food additive petition (FAP 0A4782) has been filed by U.S. 
Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852. 
The petition proposes that the food additive regulations in table 1 of 
this document, which incorporate by reference food-grade specifications 
from prior editions of the FCC, be amended to incorporate by reference 
food-grade specifications from the FCC, 7th Edition.

                                                              Table 1.--List of Regulations
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                 FCC Edition and/or Supplement
               21 CFR Section                        Currently Referenced             Name of Additive                 Current FCC Reference
--------------------------------------------------------------------------------------------------------------------------------------------------------
172.167(b)                                                               6th Ed.        Hydrogen peroxide                      Meets FCC specifications.
--------------------------------------------------------------------------------------------------------------------------------------------------------
172.320(b)(1)                                                             3d Ed.              Amino acids                      Meets FCC specifications.
--------------------------------------------------------------------------------------------------------------------------------------------------------
172.345(b)                                                               4th Ed.     Folic acid (folacin)                      Meets FCC specifications.
--------------------------------------------------------------------------------------------------------------------------------------------------------
172.379(b)                                                               6th Ed.               Vitamin D2                      Meets FCC specifications.
--------------------------------------------------------------------------------------------------------------------------------------------------------
172.380(b)                                                               5th Ed.               Vitamin D3                      Meets FCC specifications.
--------------------------------------------------------------------------------------------------------------------------------------------------------
172.665(d)(2)                                                            4th Ed.               Gellan gum        Residual isopropyl alcohol limit not to
                                                                                                             exceed 0.075% by the procedure described in
                                                                                                                              the Xanthan Gum monograph.
--------------------------------------------------------------------------------------------------------------------------------------------------------
172.712(b)                                                               4th Ed.      1,3-Butylene glycol   Conforms to FCC identity and specifications.
--------------------------------------------------------------------------------------------------------------------------------------------------------
172.723(b)(3)                                                            4th Ed.   Epoxidized soybean oil  Heavy metals (as lead) content cannot be more
                                                                                                           than 10 parts per million (ppm) as determined
                                                                                                                           by the ``Heavy Metals Test.''
--------------------------------------------------------------------------------------------------------------------------------------------------------
172.736(b)(2)                                                            5th Ed.           Glycerides and    Acid value not greater than 2, and hydroxyl
                                                                                          polyglycides of    value, not greater than 56 as determined by
                                                                                   hydrogenated vegetable          ``Acid Value'' and ``Hydroxyl Value''
                                                                                                     oils                                       methods.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 48354]]

 
172.780(b)                                                               5th Ed.      Acacia (gum arabic)                      Meets FCC specifications.
--------------------------------------------------------------------------------------------------------------------------------------------------------
172.800(b)(2)                                                             3d Ed.     Acesulfame potassium       Fluoride content not more than 30 ppm as
                                                                                                                determined by Method III of the Fluoride
                                                                                                                                             Limit Test.
--------------------------------------------------------------------------------------------------------------------------------------------------------
172.804(b)                                                     3d Ed., 1st Supp.                Aspartame                      Meets FCC specifications.
--------------------------------------------------------------------------------------------------------------------------------------------------------
172.810                                                                   3d Ed.           Dioctyl sodium                      Meets FCC specifications.
                                                                                           sulfosuccinate
--------------------------------------------------------------------------------------------------------------------------------------------------------
172.812(a)                                                                3d Ed.                  Glycine                      Meets FCC specifications.
--------------------------------------------------------------------------------------------------------------------------------------------------------
172.831(b)                                                               4th Ed.                Sucralose                      Meets FCC specifications.
--------------------------------------------------------------------------------------------------------------------------------------------------------
172.833(b)(4)                                                            4th Ed.          Sucrose acetate  Lead not to exceed 1.0 milligram/kilogram (mg/
                                                                                       isobutyrate (SAIB)      kg) determined by the ``Atomic Absorption
                                                                                                             Spectrophotometric Graphite Furnace Method,
                                                                                                            Method I,'' with an attached modification to
                                                                                                                               sample digestion section.
--------------------------------------------------------------------------------------------------------------------------------------------------------
172.841(b)                                                    5th Ed., 1st Supp.             Polydextrose                      Meets FCC specifications.
--------------------------------------------------------------------------------------------------------------------------------------------------------
172.846(b)                                                                3d Ed.          Sodium stearoyl                      Meets FCC specifications.
                                                                                                lactylate
--------------------------------------------------------------------------------------------------------------------------------------------------------
172.858(a)                                                                3d Ed.         Propylene glycol                      Meets FCC specifications.
                                                                                                 alginate
--------------------------------------------------------------------------------------------------------------------------------------------------------
172.862(b)(1)                                                             3d Ed.  Oleic acid derived from     Meets FCC specifications except that titer
                                                                                     tall oil fatty acids   (solidification point) shall not exceed 13.5
                                                                                                               degrees Celsius and unsaponifiable matter
                                                                                                                                  shall not exceed 0.5%.
--------------------------------------------------------------------------------------------------------------------------------------------------------
172.867(b)                                                    4th Ed., 1st Supp.                  Olestra                      Meets FCC specifications.
--------------------------------------------------------------------------------------------------------------------------------------------------------
172.869(b)(6)                                                            4th Ed.      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)                                                            4th Ed.      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)                                                 4th Ed., 1st Supp.      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)                                                 4th Ed., 1st Supp.      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)                                                4th Ed., 1st Supp.      Sucrose oligoesters    Residual isobutyl alcohol not more than 1.0
                                                                                                             mg/kg as determined by the method listed in
                                                                                                            the monograph ``Sucrose Fatty Acid Esters.''
--------------------------------------------------------------------------------------------------------------------------------------------------------
172.869(b)(11)                                                           4th Ed.      Sucrose oligoesters  Lead not more than 1.0 mg/kg as determined by
                                                                                                                  ``Atomic Absorption Spectrophotometric
                                                                                                                    Graphite Furnace Method,'' Method I.
--------------------------------------------------------------------------------------------------------------------------------------------------------
173.115(b)(3)                                                            4th Ed.       Alpha-acetolactate       Enzyme preparation must meet general and
                                                                                   decarboxylase (a-ALDC)             additional requirements for enzyme
                                                                                       enzyme preparation                           preparations in FCC.
                                                                                           derived from a
                                                                                     recombinant Bacillus
                                                                                                 subtilis
--------------------------------------------------------------------------------------------------------------------------------------------------------
173.160(d)                                                                3d Ed.   Candida guilliermondii       Citric acid produced must conform to FCC
                                                                                                                 specifications (under ``Citric acid'').
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 48355]]

 
173.165(d)                                                                3d Ed.       Candida lipolytica       Citric acid produced must conform to FCC
                                                                                                                 specifications (under ``Citric acid'').
--------------------------------------------------------------------------------------------------------------------------------------------------------
173.228(a)                                                               4th Ed.            Ethyl acetate                      Meets FCC specifications.
--------------------------------------------------------------------------------------------------------------------------------------------------------
173.280(c)                                                                3d Ed.       Solvent extraction                      Meets FCC specifications.
                                                                                  process for citric acid
--------------------------------------------------------------------------------------------------------------------------------------------------------
173.310(c)                                                               4th Ed.  Boiler water additives;              Contains not less than 95% sodium
                                                                                                   Sodium  carboxymethylcellulose on a dry-weight basis,
                                                                                   carboxymethylcellulose               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 method cited in
                                                                                                                                                    FCC.
--------------------------------------------------------------------------------------------------------------------------------------------------------
173.310(c)                                                               4th Ed.  Boiler water additives;                      Meets FCC specifications.
                                                                                       Sorbitol anhydride
                                                                                                   esters
--------------------------------------------------------------------------------------------------------------------------------------------------------
173.368(c)                                                               4th Ed.                    Ozone                      Meets FCC specifications.
--------------------------------------------------------------------------------------------------------------------------------------------------------
178.1005(c)                                                               3d Ed.        Hydrogen peroxide                      Meets FCC specifications.
                                                                                                 solution
--------------------------------------------------------------------------------------------------------------------------------------------------------
180.25(b)                                                                 3d Ed.                 Mannitol                      Meets FCC specifications.
--------------------------------------------------------------------------------------------------------------------------------------------------------
180.30(a)                                                                 3d Ed.     Brominated vegetable                      Meets FCC specifications.
                                                                                                      oil
--------------------------------------------------------------------------------------------------------------------------------------------------------
180.37(b)                                                                 3d Ed.      Saccharin, ammonium                      Meets FCC specifications.
                                                                                       saccharin, calcium
                                                                                    saccharin, and sodium
                                                                                                saccharin
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The agency has determined under 21 CFR 25.30(i) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

    Dated: August 4, 2010.
Catherine L. Copp,
Acting Director, Office of Food Additive Safety, Center for Food Safety 
and Applied Nutrition.
[FR Doc. 2010-19722 Filed 8-9-10; 8:45 am]
BILLING CODE 4160-01-S