Document ID: FDA-2008-N-0068-0001
Agency: fda
Document Type: Rule
Title: Generally Recognized As Safe Substances; Technical Amendments
Posted Date: 2008-02-14T05:00Z

[Federal Register: February 14, 2008 (Volume 73, Number 31)]
[Rules and Regulations]               
[Page 8606-8608]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14fe08-13]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 184

[Docket No. FDA-2008-N-0068]

 
Generally Recognized As Safe Substances; Technical Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA) is amending certain 
regulations regarding generally recognized as safe (GRAS) substances to 
remove references to FDA development of food-grade specifications in 
cooperation with the National Academy of Sciences (NAS, now the 
National Academies). This action is editorial in nature and is intended 
to ensure the accuracy of the agency's regulations.

DATES: This rule is effective February 14, 2008.

FOR FURTHER INFORMATION CONTACT:  Daniel E. Folmer, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1274.

SUPPLEMENTARY INFORMATION: FDA is amending its regulations in part 184 
(21 CFR part 184). Several sections in part 184 state that FDA is 
developing food-grade specifications in cooperation with the National 
Academy of Sciences (NAS, now the National Academies). However, the 
National Academies is no longer developing food-grade specifications 
for food additives and ingredients. Therefore, this rule removes the 
obsolete information.
    The 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.
    Publication of this document constitutes final action on these 
changes under the Administrative Procedure Act (5 U.S.C. 553). These 
amendments remove obsolete information and are nonsubstantive. FDA 
therefore, for good cause, finds under 5 U.S.C. 553(b)(3)(B) and (d)(3) 
that notice and public comment are unnecessary.

List of Subjects in 21 CFR Part 184

    Food additives.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
184 is amended as follows:

PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED 
AS SAFE

0
1. The authority citation for 21 CFR part 184 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 348, 371.

0
2. Section 184.1065 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1065  Linoleic acid.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use. The ingredient must also meet the specifications in Sec.  
172.860(b) of this chapter.
* * * * *

0
3. Section 184.1140 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1140  Ammonium citrate, dibasic.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
4. Section 184.1155 is amended by revising paragraph (b) to read as 
follows:

[[Page 8607]]

Sec.  184.1155  Bentonite.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
5. Section 184.1165 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1165  n-Butane and iso-butane.

* * * * *
    (b) The ingredients must be of a purity suitable for their intended 
use.
* * * * *

0
6. Section 184.1240 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1240  Carbon dioxide.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
7. Section 184.1261 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1261  Copper sulfate.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
8. Section 184.1262 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1262  Corn silk and corn silk extract.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
9. Section 184.1265 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1265  Cuprous iodide.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
10. Section 184.1287 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1287  Enzyme-modified fats.

* * * * *
    (b) The ingredients must be of a purity suitable for their intended 
use.
* * * * *

0
11. Section 184.1297 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1297  Ferric chloride.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
12. Section 184.1298 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1298  Ferric citrate.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
13. Section 184.1307 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1307  Ferric sulfate.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
14. Section 184.1307a is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1307a  Ferrous ascorbate.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
15. Section 184.1307b is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1307b  Ferrous carbonate.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
16. Section 184.1307c is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1307c  Ferrous citrate.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
17. Section 184.1321 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1321  Corn gluten.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
18. Section 184.1322 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1322  Wheat gluten.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
19. Section 184.1323 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1323  Glyceryl monooleate.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
20. Section 184.1324 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1324  Glyceryl monostearate.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
21. Section 184.1355 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1355  Helium.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
22. Section 184.1386 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1386  Isopropyl citrate.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
23. Section 184.1445 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1445  Malt syrup (malt extract).

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
24. Section 184.1449 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1449  Manganese citrate.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
25. Section 184.1521 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1521  Monosodium phosphate derivatives of mono- and 
diglycerides.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
26. Section 184.1537 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1537  Nickel.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
27. Section 184.1540 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1540  Nitrogen.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
28. Section 184.1545 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1545  Nitrous oxide.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
29. Section 184.1553 is amended by revising paragraph (b) to read as 
follows:

[[Page 8608]]

Sec.  184.1553  Peptones.

* * * * *
    (b) The ingredients must be of a purity suitable for their intended 
use.
* * * * *

0
30. Section 184.1555 is amended by revising paragraph (c)(3) to read as 
follows:

Sec.  184.1555  Rapeseed oil.

* * * * *
    (c) * * *
    (3) In addition to limiting the content of erucic acid to a level 
not exceeding 2 percent of the component fatty acids, low erucic acid 
rapeseed oil and partially hydrogenated low erucic acid rapeseed oil 
must be of a purity suitable for their intended use.
* * * * *

0
31. Section 184.1639 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1639  Potassium lactate.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
32. Section 184.1655 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1655  Propane.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
33. Section 184.1764 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1764  Sodium hypophosphite.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
34. Section 184.1768 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1768  Sodium lactate.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
35. Section 184.1769a is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1769a  Sodium metasilicate.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
36. Section 184.1848 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1848  Starter distillate.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
37. Section 184.1851 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1851  Stearyl citrate.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
38. Section 184.1854 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1854  Sucrose.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
39. Section 184.1859 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1859  Invert sugar.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
40. Section 184.1865 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1865  Corn syrup.

* * * * *
    (b) The ingredient meets the specifications as defined and 
determined in Sec.  168.120(b) or Sec.  168.121(a) of this chapter, as 
appropriate.
* * * * *

0
41. Section 184.1923 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1923  Urea.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

0
42. Section 184.1950 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1950  Vitamin D.

* * * * *
    (b) Vitamin D2 and vitamin D3 as crystals 
meet the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 
344 and 345, which is incorporated by reference. Copies are available 
from the National Academy Press, 2101 Constitution Ave. NW., 
Washington, DC 20418, or available for inspection 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/code_of_federal_
regulations_/ibr_locations.html. Vitamin D2 resin and 
vitamin D3 resin must be of a purity suitable for their 
intended use.
* * * * *

0
43. Section 184.1984 is amended by revising paragraph (b) to read as 
follows:

Sec.  184.1984  Zein.

* * * * *
    (b) The ingredient must be of a purity suitable for its intended 
use.
* * * * *

    Dated: February 8, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-2809 Filed 2-13-08; 8:45 am]

BILLING CODE 4160-01-S