81 FR 5589 - Center for Food Safety and Applied Nutrition Library Address; Technical Amendments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 22 (February 3, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 22 (February 3, 2016)
| Page Range | 5589-5596 | |
| FR Document | 2016-01787 |
[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)] [Rules and Regulations] [Pages 5589-5596] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-01787] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 73, 101, 118, 165, 172, 173, 177, 178, 184, 189, 589, and 700 [Docket No. FDA-2015-N-0011] Center for Food Safety and Applied Nutrition Library Address; Technical Amendments AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is amending certain regulations to update the location of references cited in our food regulations. We are taking this action to reflect the transfer of those references from our facility in College Park, MD, to our library at our main campus in Silver Spring, MD. We also are updating certain regulations to reflect the current names for specific FDA offices. DATES: This rule is effective February 3, 2016. FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Center for Food Safety and Applied Nutrition (HFS-024), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-2112. SUPPLEMENTARY INFORMATION: Various regulations pertaining to human food have incorporated materials by reference. In general, the regulations have identified a library at the Center for Food Safety and Applied Nutrition (CFSAN), which was (at the time the regulations were published) located in Washington, DC, or in College Park, MD. We recently consolidated our library holdings at our main campus in Silver Spring, MD. Consequently, we are making technical amendments to our regulations at parts 73, 101, 118, 165, 172, 173, 177, 178, 184, 189, 589, and 700 (21 CFR parts 73, 101, 118, 165, 172, 173, 177, 178, 184, 189, 589, and 700) to state that the materials can be found at the FDA Library in Silver Spring, MD. We also are updating certain regulations to reflect the current names for specific FDA offices. The amendments are as follows:We are revising Sec. Sec. 73.165, 73.585, 165.110, and 173.300 to update the library address from ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD'' to ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796- 2039''. We are revising Sec. Sec. 101.4, 101.81(c)(2)(ii)(A) introductory text and (B)(1) and (2), 101.83, 165.110, 172.155, 172.785, 172.833, 173.25, 173.45, 173.340, 173.357, 173.370, 177.1350, 177.1360, 177.1390, 177.1520, 177.2600, 178.3297, 184.1063, 184.1148, 184.1150, 184.1250, 184.1387, 184.1420, 184.1444, 184.1866, 189.5, 589.2001, and 700.27 to update the library address from ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' to ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. We are revising Sec. 101.80 to update the library address from ``Center for Food Safety and Applied Nutrition's Library, Harvey W. Wiley Federal Building, 5100 Paint Branch Pkwy., College Park, MD'' to ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. We are revising Sec. 101.81(c)(2)(ii)(A)(5) to update the library address from ``Center for Food Safety and Applied Nutrition Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' to ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. We are revising Sec. Sec. 118.8 and 165.110 to update the library address from ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD, 301-436-2163'' to ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. We are revising Sec. 165.110 to update the library address from ``Center for Food Safety and Applied Nutrition's Library, 200 C St. NW., Washington DC'' to ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. We are revising Sec. Sec. 165.110, 172.723, 172.736, 172.804, 172.809, 172.864, 172.886, 173.375, 177.1345, 177.1585, 177.1637, 178.1010, 184.1007, 184.1257, 184.1259, 184.1282, 184.1293, 184.1472, 184.1530, 184.1699, 184.1979, 184.1979a, 184.1979b, and 184.1979c to update the library address from ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740'' to ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. We are revising Sec. Sec. 172.167 and 173.356 to update the library address from ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2163'' to ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. We are revising Sec. 172.736 to update the library address from ``in the library at the Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740'' to ``at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. We are revising Sec. 172.829 to update the library address from ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., rm. 1C-100, College Park, MD 20740'' to ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. We are revising Sec. 173.325 to update the library address from ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740 20204-0001'' to ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. We are revising Sec. 184.1311 to update the library address from ``Center for Food Safety and Applied Nutrition's library, 5100 Paint Branch Pkwy., College Park, MD 20740'' to ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. We are revising Sec. 101.83(c)(2)(ii)(A)(2) and (c)(2)(ii)(B)(2), to remove the words ``Office of Nutritional Products, Labeling, and Dietary Supplements, Division of Nutrition Science and Policy,'' and in their place add ``Office [[Page 5590]] of Nutrition, Labeling and Dietary Supplements, Nutrition Programs Staff''. We are revising Sec. 118.8 to replace ``The FDA'' with ``FDA''. We are revising Sec. 173.300 to add the words ``Office of Food Additive Safety''. We are revising Sec. 173.340 to remove the words ``Division of Petition Control'' and ``(HFS-215)'' and in their place adding ``Office of Food Additive Safety (HFS-200)''. We are revising Sec. 173.357 to remove the words ``Division of Petition Control'' and ``(HFS-215)'' and in their place adding ``Office of Food Additive Safety (HFS-200)''. We are updating Sec. Sec. 177.1520 and 177.1585 to remove the words ``Office of Premarket Approval'' and in their place adding the ``Office of Food Additive Safety''. Publication of this document constitutes final action of these changes under the Administrative Procedure Act (5 U.S.C. 553). These amendments are merely updating the address of CFSAN references and the names of CFSAN offices. 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 21 CFR Part 73 Color additives, Cosmetics, Drugs, Medical devices. 21 CFR Part 101 Food labeling, Nutrition, Reporting and recordkeeping requirements. 21 CFR Part 118 Egg and egg products, Incorporation by reference, Recordkeeping requirements, Safety. 21 CFR Part 165 Beverages, Bottled water, Food grades and standards, Incorporation by reference. 21 CFR Part 172 Food additives, Reporting and recordkeeping requirements. 21 CFR Part 173 Food additives. 21 CFR Part 177 Food additives, Food packaging. 21 CFR Part 178 Food additives, Food packaging. 21 CFR Part 184 Food additives. 21 CFR Part 189 Food additives, Food packaging. 21 CFR Part 589 Animal feeds, Animal foods, Food additives. 21 CFR Part 700 Cosmetics, Packaging and containers. 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 73, 101, 118, 165, 172, 173, 177, 178, 184, 189, 589, and 700 are amended as follows: PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION 0 1. The authority citation for 21 CFR part 73 continues to read as follows: Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e. Sec. 73.165 [Amended] 0 2. Amend Sec. 73.165 in paragraph (b) by removing ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 73.585 [Amended] 0 3. Amend Sec. 73.585 in paragraph (b) by removing ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. PART 101--FOOD LABELING 0 4. The authority citation for 21 CFR part 101 continues to read as follows: Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 243, 264, 271. Sec. 101.4 [Amended] 0 5. Amend Sec. 101.4 in paragraphs (h) introductory text and (h)(2) by removing ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' wherever it appears and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 101.80 [Amended] 0 6. Amend Sec. 101.80 in paragraph (c)(2)(iii)(C) by removing ``Center for Food Safety and Applied Nutrition's Library, Harvey W. Wiley Federal Building, 5100 Paint Branch Pkwy., College Park, MD'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 101.81 [Amended] 0 7. Amend Sec. 101.81 as follows: 0 a. In paragraphs (c)(2)(ii)(A) introductory text and (c)(2)(ii)(B)(1) and (2) remove ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' wherever it appears and add in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. 0 b. In paragraph (c)(2)(ii)(A)(5) remove ``Center for Food Safety and Applied Nutrition Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' and add in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 101.83 [Amended] 0 8. Amend Sec. 101.83 in paragraphs (c)(2)(ii)(A)(2) and (c)(2)(ii)(B)(2) as follows: 0 a. Remove ``Office of Nutritional Products, Labeling, and Dietary Supplements, Division of Nutrition Science and Policy'' and add in its place ``Office of Nutrition, Labeling and Dietary Supplements, Nutrition Programs Staff''. 0 b. Remove ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' wherever it appears and add in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. PART 118--PRODUCTION, STORAGE, AND TRANSPORTATION OF SHELL EGGS 0 9. The authority citation for 21 CFR part 118 continues to read as follows: Authority: 21 U.S.C. 321, 331-334, 342, 371, 381, 393; 42 U.S.C. 243, 264, 271. Sec. 118.8 [Amended] 0 10. Amend Sec. 118.8 in paragraphs (a) and (b) as follows: 0 a. Remove ``The FDA'' wherever it appears and add in its place ``FDA''. 0 b. Remove ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD, [[Page 5591]] 301-436-2163'' wherever it appears and add in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. PART 165--BEVERAGES 0 11. The authority citation for 21 CFR part 165 continues to read as follows: Authority: 21 U.S.C. 321, 341, 343, 343-1, 348, 349, 371, 379e. Sec. 165.110 [Amended] 0 12. Amend Sec. 165.110 as follows: 0 a. In paragraphs (a)(2)(iv) and (vii), (b)(4)(iii)(E)(7)(iv), and (b)(4)(iii)(I), remove ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' wherever it appears and add in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. 0 b. In paragraphs (b)(2)(ii) and (b)(3) introductory text, remove ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2163'' wherever it appears and add in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. 0 c. In paragraph (b)(4)(i)(C) introductory text, remove ``Center for Food Safety and Applied Nutrition's Library, 200 C St. NW., Washington DC'' and add in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039.'' 0 d. In paragraphs (b)(4)(iii)(E) introductory text, (b)(4)(iii)(E)(1)(ii) and (iv), (b)(4)(iii)(E)(11)(i), (b)(4)(iii)(E)(14)(i), and (b)(4)(iii)(F)(20), remove ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740'' wherever it appears and add in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. 0 e. In paragraph (b)(5)(ii) introductory text, remove ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD'' and add in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION 0 13. The authority citation for 21 CFR part 172 continues to read as follows: Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e. Sec. 172.155 [Amended] 0 14. Amend Sec. 172.155 in paragraph (c) by removing ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 172.167 [Amended] 0 15. Amend Sec. 172.167 in paragraph (d)(2) by removing ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301- 436-2163'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 172.723 [Amended] 0 16. Amend Sec. 172.723 in paragraph (b)(3) by removing ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 172.736 [Amended] 0 17. Amend Sec. 172.736 as follows: 0 a. In paragraph (b)(1), remove ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740'' and add in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. 0 b. In paragraph (b)(3), remove ``in the library at the Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740'' and add in its place ``at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 172.785 [Amended] 0 18. Amend Sec. 172.785 in paragraph (b)(1) by removing ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 172.804 [Amended] 0 19. Amend Sec. 172.804 in paragraph (c)(2) by removing ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 172.809 [Amended] 0 20. Amend Sec. 172.809 in paragraph (b) introductory text by removing ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 172.829 [Amended] 0 21. Amend Sec. 172.829 in paragraph (b) introductory text by removing ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., Rm. 1C-100, College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796- 2039''. Sec. 172.833 [Amended] 0 22. Amend Sec. 172.833 in paragraphs (b)(2) and (4) by removing ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' wherever it appears and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796- 2039''. Sec. 172.864 [Amended] 0 23. Amend Sec. 172.864 in paragraph (a)(3) by removing ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. [[Page 5592]] Sec. 172.886 [Amended] 0 24. Amend Sec. 172.886 in paragraph (c)(2)(iii) by removing ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION 0 25. The authority citation for 21 CFR part 173 continues to read as follows: Authority: 21 U.S.C. 321, 342, 348. Sec. 173.25 [Amended] 0 26. Amend Sec. 173.25 in paragraph (b)(2)(ii)(B) by removing ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 173.45 [Amended] 0 27. Amend Sec. 173.45 in paragraph (a) by removing ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 173.300 [Amended] 0 28. Amend Sec. 173.300 in paragraph (a)(2) as follows: 0 a. Remove ``Center for Food Safety and Applied Nutrition (HFS-200)'' and add in its place ``Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition''. 0 b. Remove ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD'' and add in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 173.325 [Amended] 0 29. Amend Sec. 173.325 in paragraph (h) by removing ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740 20204-0001'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. 0 30. Amend Sec. 173.340 in the table in paragraph (a)(4) by revising the entry ``n-Butoxypoly(oxyethylene)-poly(oxypropylene)glycol'' to read as follows: Sec. 173.340 Defoaming agents. * * * * * (a) * * * (4) * * * ------------------------------------------------------------------------ Substances Limitations ------------------------------------------------------------------------ n-Butoxypoly(oxyethylene)- Viscosity range, 4,850-5,350 poly(oxypropylene)glycol. Saybolt Universal Seconds (SUS) at 37.8 [deg]C (100 [deg]F). The viscosity range is determined by the method ``Viscosity Determination of n- butoxypoly(oxyethylene)- poly(oxypropylene) glycol'' dated April 26, 1995, developed by Union Carbide Corp., P.O. Box 670, Bound Brook, NJ 08805, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the material incorporated by reference are available from the Office of Food Additive Safety (HFS- 200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and 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/code_of_federal_regulations/ibr_locations.html. * * * * * * * ------------------------------------------------------------------------ * * * * * Sec. 173.356 [Amended] 0 31. Amend Sec. 173.356 in paragraph (a) by removing ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2163'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. 0 32. Amend Sec. 173.357 in the table in paragraph (a)(2) by revising the entry ``Polyethylenimine reaction product with 1,2-dichloroethane (CAS Reg. No. 68130-97-2)'' to read as follows: Sec. 173.357 Materials used as fixing agents in the immobilization of enzyme preparations. * * * * * (a) * * * (2) * * * [[Page 5593]] ------------------------------------------------------------------------ Substances Limitations ------------------------------------------------------------------------ * * * * * * * Polyethylenimine reaction product with May be used as a fixing 1,2-dichloroethane (CAS Reg. No. 68130- material in the immobilization 97-2) is the reaction product of of glucoamylase enzyme homopolymerization of ethylenimine in preparations from Aspergillus aqueous hydrochloric acid at 100 niger for use in the [deg]C and of cross-linking with 1,2- manufacture of beer. dichloroethane. The finished polymer May be used as a fixing has an average molecular weight of material in the immobilization 50,000 to 70,000 as determined by gel of: permeation chromatography. The 1. Glucose isomerase enzyme analytical method is entitled preparations for use in the ``Methodology for Molecular Weight manufacture of high fructose Detection of Polyethylenimine,'' which corn syrup, in accordance with is incorporated by reference in Sec. 184.1372 of this accordance with 5 U.S.C. 552(a) and 1 chapter. CFR part 51. Copies may be obtained 2. Glucoamylase enzyme from the Office of Food Additive preparations from Aspergillus Safety (HFS-200), Center for Food niger for use in the Safety and Applied Nutrition, 5100 manufacture of beer. Residual Paint Branch Pkwy., College Park, MD ethylenimine in the finished 20740, and may be examined at the Food polyethylenimine polymer will and Drug Administration's Main be less than 1 part per Library, 10903 New Hampshire Ave., million as determined by gas Bldg. 2, Third Floor, Silver Spring, chromatography-mass MD 20993, 301-796-2039, or at the spectrometry. The residual National Archives and Records ethylenimine is determined by Administration (NARA). For information an analytical method entitled on the availability of this material ``Methodology for Ethylenimine at NARA, call 202-741-6030, or go to: Detection in http://www.archives.gov/ Polyethylenimine,'' which is federal_register/ incorporated by reference in code_of_federal_regulations/ accordance with 5 U.S.C. ibr_locations.html. 552(a) and 1 CFR part 51. Residual 1,2-dichloroethane in the finished polyethylenimine polymer will be less than 1 part per million as determined by gas chromatography. The residual 1,2-dichloroethane is determined by an analytical method entitled, ``Methodology for Ethylenedichloride Detection in Polyethylenimine,'' which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740, or 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/code_of_federal_regulations/ibr_locations.html. ------------------------------------------------------------------------ * * * * * Sec. 173.370 [Amended] 0 33. Amend Sec. 173.370 in paragraph (c) by removing ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 173.375 [Amended] 0 34. Amend Sec. 173.375 in paragraph (a) by removing ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796- 2039''. PART 177--INDIRECT FOOD ADDITIVES: POLYMERS 0 35. The authority citation for 21 CFR part 177 continues to read as follows: Authority: 21 U.S.C. 321, 342, 348, 379e. Sec. 177.1345 [Amended] 0 36. Amend Sec. 177.1345 in paragraph (b)(1) by removing ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 177.1350 [Amended] 0 37. Amend Sec. 177.1350 in paragraph (b)(2) by removing ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 177.1360 [Amended] 0 38. Amend Sec. 177.1360 in paragraph (d) by removing ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 177.1390 [Amended] 0 39. Amend Sec. 177.1390 in paragraph (c)(3)(i)(a)(1) by removing ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. 0 40. Amend Sec. 177.1520 in the table in paragraph (b) by revising the entry ``Methyl methacrylate/butyl acrylate-grafted polypropylene copolymer containing methyl methacrylate/butyl acrylate-grafted polypropylene (CAS Reg. No. 121510-09-6)'' to read as follows: Sec. 177.1520 Olefin polymers. * * * * * (b) * * * [[Page 5594]] ------------------------------------------------------------------------ Substance Limitations ------------------------------------------------------------------------ * * * * * * * Methyl methacrylate/butyl acrylate- For use only at levels not to grafted polypropylene copolymer exceed 6 percent by weight of containing methyl methacrylate/butyl olefin polymers complying with acrylate-grafted polypropylene (CAS paragraph (c) of this section, Reg. No. 121510-09-6), methyl items 1.1, 3.1a, 3.2a, and methacrylate/butyl acrylate copolymer 3.2b, where the copolymers (CAS Reg. No. 25852-37-3), methyl complying with items 3.1a, methacrylate homopolymer (CAS Reg. No. 3.2a, and 3.2b contain not 9011-14-7), and polypropylene (CAS less than 85 weight-percent of Reg. No. 9003-07-0), resulting from polymer units derived from the reaction of a mixture of methyl propylene. methacrylate and butyl acrylate with polypropylene. The finished product contains no more than 55 percent by weight of polymer units derived from methyl methacrylate and butyl acrylate as determined by a method entitled, ``Determination of the Total Acrylic in PP-MMA/BA Polymers,'' which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or 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/code_of_federal_regulations/ibr_locations.html. * * * * * * * ------------------------------------------------------------------------ * * * * * Sec. 177.1585 [Amended] 0 41. Amend Sec. 177.1585 in paragraph (c)(1)(i) as follows: 0 a. Remove ``Office of Premarket Approval'' and add in its place ``Office of Food Additive Safety''. 0 b. Remove ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740'' and add in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 177.1637 [Amended] 0 42. Amend Sec. 177.1637 in paragraph (b)(2) by removing ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 177.2600 [Amended] 0 43. Amend Sec. 177.2600 in paragraph (c)(4)(i) by removing ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS 0 44. The authority citation for 21 CFR part 178 continues to read as follows: Authority: 21 U.S.C. 321, 342, 348, 379e. Sec. 178.1010 [Amended] 0 45. Amend Sec. 178.1010 in paragraph (c)(40) by removing ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 178.3297 [Amended] 0 46. Amend Sec. 178.3297 in the table in paragraph (e) by revising the entry ``High-purity furnace black (CAS Reg. No. 1333-86-4)'' to read as follows: Sec. 178.3297 Colorants for polymers. * * * * * (e) * * * [[Page 5595]] ------------------------------------------------------------------------ Substances Limitations ------------------------------------------------------------------------ * * * * * * * High-purity furnace black (CAS Reg. No. For use at levels not to exceed 1333-86-4) containing total 2.5 percent by weight of the polynuclear aromatic hydrocarbons not polymer. to exceed 0.5 parts per million, and benzo[a]pyrene not to exceed 5.0 parts per billion, as determined by a method entitled ``Determination of PAH Content of Carbon Black,'' dated July 8, 1994, as developed by the Cabot Corp., which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1200, or 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/code_of_federal_regulations/ibr_locations.html. * * * * * * * ------------------------------------------------------------------------ PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE 0 47. The authority citation for 21 CFR part 184 continues to read as follows: Authority: 21 U.S.C. 321, 342, 348, 371. Sec. 184.1007 [Amended] 0 48. Amend Sec. 184.1007 in paragraph (b)(1) by removing ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 184.1063 [Amended] 0 49. Amend Sec. 184.1063 in paragraphs (b) introductory text and (b)(8) by removing ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' wherever it appears and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 184.1148 [Amended] 0 50. Amend Sec. 184.1148 in paragraph (b) by removing ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 184.1150 [Amended] 0 51. Amend Sec. 184.1150 in paragraph (b) by removing ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 184.1250 [Amended] 0 52. Amend Sec. 184.1250 in paragraph (b) by removing ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 184.1257 [Amended] 0 53. Amend Sec. 184.1257 in paragraph (b) by removing ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796- 2039''. Sec. 184.1259 [Amended] 0 54. Amend Sec. 184.1259 in paragraph (b)(3) by removing ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 184.1282 [Amended] 0 55. Amend Sec. 184.1282 in paragraph (b) by removing ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796- 2039''. Sec. 184.1293 [Amended] 0 56. Amend Sec. 184.1293 in paragraph (b) by removing ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796- 2039.'' Sec. 184.1311 [Amended] 0 57. Amend Sec. 184.1311 in paragraph (b) by removing ``Center for Food Safety and Applied Nutrition's library, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039.'' Sec. 184.1387 [Amended] 0 58. Amend Sec. 184.1387 in paragraph (b) by removing ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 184.1420 [Amended] 0 59. Amend Sec. 184.1420 in paragraph (b) by removing ``Center for Food Safety [[Page 5596]] and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 184.1444 [Amended] 0 60. Amend Sec. 184.1444 in paragraph (b)(3) by removing ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 184.1472 [Amended] 0 61. Amend Sec. 184.1472 in paragraph (a)(2)(iii) by removing ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 184.1530 [Amended] 0 62. Amend Sec. 184.1530 in paragraph (b) by removing ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796- 2039''. Sec. 184.1699 [Amended] 0 63. Amend Sec. 184.1699 in paragraph (b) by removing ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796- 2039''. Sec. 184.1866 [Amended] 0 64. Amend Sec. 184.1866 in paragraph (b) by removing ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 184.1979 [Amended] 0 65. Amend Sec. 184.1979 in paragraphs (b)(1) and (2) by removing ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740'' wherever it appears and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 184.1979a [Amended] 0 66. Amend Sec. 184.1979a in paragraphs (b)(1) introductory text and (b)(2) by removing ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740'' wherever it appears and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 184.1979b [Amended] 0 67. Amend Sec. 184.1979b in paragraphs (b)(1) introductory text and (b)(2) by removing ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740'' wherever it appears and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Sec. 184.1979c [Amended] 0 68. Amend Sec. 184.1979c in paragraphs (b)(1) introductory text and (b)(2) by removing ``Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740'' wherever it appears and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD 0 69. The authority citation for 21 CFR part 189 continues to read as follows: Authority: 21 U.S.C. 321, 342, 348, 371, 381. Sec. 189.5 [Amended] 0 70. Amend Sec. 189.5 in paragraph (a)(6) by removing ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. PART 589--SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED 0 71. The authority citation for 21 CFR part 589 continues to read as follows: Authority: 21 U.S.C. 321, 342, 343, 348, 371. Sec. 589.2001 [Amended] 0 72. Amend Sec. 589.2001 in paragraph (b)(1)(vi)(B) by removing ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. PART 700--GENERAL 0 73. The authority citation for 21 CFR part 700 continues to read as follows: Authority: 21 U.S.C. 321, 331, 352, 355, 361, 362, 371, 374. Sec. 700.27 [Amended] 0 74. Amend Sec. 700.27 in paragraph (a)(6) by removing ``Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740'' and adding in its place ``Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039''. Dated: January 27, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-01787 Filed 2-2-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Rules and Regulations 5589
Dated: January 15, 2016. names for specific FDA offices. The 172.864, 172.886, 173.375, 177.1345,
Pamela M. Bush, amendments are as follows: 177.1585, 177.1637, 178.1010, 184.1007,
Commission Secretary and Assistant General • We are revising §§ 73.165, 73.585, 184.1257, 184.1259, 184.1282, 184.1293,
Counsel. 165.110, and 173.300 to update the 184.1472, 184.1530, 184.1699, 184.1979,
[FR Doc. 2016–02048 Filed 2–2–16; 8:45 am] library address from ‘‘Center for Food 184.1979a, 184.1979b, and 184.1979c to
BILLING CODE 6360–01–P
Safety and Applied Nutrition’s Library, update the library address from ‘‘Center
5100 Paint Branch Pkwy., College Park, for Food Safety and Applied Nutrition’s
MD’’ to ‘‘Food and Drug Library, Food and Drug Administration,
Administration’s Main Library, 10903 5100 Paint Branch Pkwy., College Park,
DEPARTMENT OF HEALTH AND New Hampshire Ave., Bldg. 2, Third MD 20740’’ to ‘‘Food and Drug
HUMAN SERVICES Floor, Silver Spring, MD 20993, 301– Administration’s Main Library, 10903
796–2039’’. New Hampshire Ave., Bldg. 2, Third
Food and Drug Administration • We are revising §§ 101.4, Floor, Silver Spring, MD 20993, 301–
101.81(c)(2)(ii)(A) introductory text and 796–2039’’.
21 CFR Parts 73, 101, 118, 165, 172, (B)(1) and (2), 101.83, 165.110, 172.155,
173, 177, 178, 184, 189, 589, and 700 • We are revising §§ 172.167 and
172.785, 172.833, 173.25, 173.45, 173.356 to update the library address
173.340, 173.357, 173.370, 177.1350, from ‘‘Center for Food Safety and
[Docket No. FDA–2015–N–0011]
177.1360, 177.1390, 177.1520, 177.2600, Applied Nutrition’s Library, Food and
Center for Food Safety and Applied 178.3297, 184.1063, 184.1148, 184.1150, Drug Administration, 5100 Paint Branch
Nutrition Library Address; Technical 184.1250, 184.1387, 184.1420, 184.1444, Pkwy., College Park, MD 20740, 301–
Amendments 184.1866, 189.5, 589.2001, and 700.27 436–2163’’ to ‘‘Food and Drug
to update the library address from Administration’s Main Library, 10903
AGENCY: Food and Drug Administration, ‘‘Center for Food Safety and Applied New Hampshire Ave., Bldg. 2, Third
HHS. Nutrition’s Library, 5100 Paint Branch Floor, Silver Spring, MD 20993, 301–
Final rule; technical
ACTION: Pkwy., College Park, MD 20740’’ to 796–2039’’.
‘‘Food and Drug Administration’s Main
amendments. • We are revising § 172.736 to update
Library, 10903 New Hampshire Ave.,
the library address from ‘‘in the library
SUMMARY: The Food and Drug Bldg. 2, Third Floor, Silver Spring, MD
at the Center for Food Safety and
Administration (FDA or we) is 20993, 301–796–2039’’.
• We are revising § 101.80 to update Applied Nutrition, 5100 Paint Branch
amending certain regulations to update
the library address from ‘‘Center for Pkwy., College Park, MD 20740’’ to ‘‘at
the location of references cited in our
Food Safety and Applied Nutrition’s the Food and Drug Administration’s
food regulations. We are taking this
Library, Harvey W. Wiley Federal Main Library, 10903 New Hampshire
action to reflect the transfer of those
Building, 5100 Paint Branch Pkwy., Ave., Bldg. 2, Third Floor, Silver Spring,
references from our facility in College
College Park, MD’’ to ‘‘Food and Drug MD 20993, 301–796–2039’’.
Park, MD, to our library at our main
Administration’s Main Library, 10903 • We are revising § 172.829 to update
campus in Silver Spring, MD. We also
New Hampshire Ave., Bldg. 2, Third the library address from ‘‘Center for
are updating certain regulations to
Floor, Silver Spring, MD 20993, 301– Food Safety and Applied Nutrition’s
reflect the current names for specific
796–2039’’. Library, 5100 Paint Branch Pkwy., rm.
FDA offices.
• We are revising 1C–100, College Park, MD 20740’’ to
DATES: This rule is effective February 3, ‘‘Food and Drug Administration’s Main
2016. § 101.81(c)(2)(ii)(A)(5) to update the
library address from ‘‘Center for Food Library, 10903 New Hampshire Ave.,
FOR FURTHER INFORMATION CONTACT: Bldg. 2, Third Floor, Silver Spring, MD
Safety and Applied Nutrition Library,
Philip L. Chao, Center for Food Safety 5100 Paint Branch Pkwy., College Park, 20993, 301–796–2039’’.
and Applied Nutrition (HFS–024), Food MD 20740’’ to ‘‘Food and Drug • We are revising § 173.325 to update
and Drug Administration, 5100 Paint Administration’s Main Library, 10903 the library address from ‘‘Center for
Branch Pkwy., College Park, MD 20740– New Hampshire Ave., Bldg. 2, Third Food Safety and Applied Nutrition’s
3835, 240–402–2112. Floor, Silver Spring, MD 20993, 301– Library, 5100 Paint Branch Pkwy.,
SUPPLEMENTARY INFORMATION: Various 796–2039’’. College Park, MD 20740 20204–0001’’ to
regulations pertaining to human food • We are revising §§ 118.8 and ‘‘Food and Drug Administration’s Main
have incorporated materials by 165.110 to update the library address Library, 10903 New Hampshire Ave.,
reference. In general, the regulations from ‘‘Center for Food Safety and Bldg. 2, Third Floor, Silver Spring, MD
have identified a library at the Center Applied Nutrition’s Library, 5100 Paint 20993, 301–796–2039’’.
for Food Safety and Applied Nutrition Branch Pkwy., College Park, MD, 301– • We are revising § 184.1311 to
(CFSAN), which was (at the time the 436–2163’’ to ‘‘Food and Drug update the library address from ‘‘Center
regulations were published) located in Administration’s Main Library, 10903 for Food Safety and Applied Nutrition’s
Washington, DC, or in College Park, MD. New Hampshire Ave., Bldg. 2, Third library, 5100 Paint Branch Pkwy.,
We recently consolidated our library Floor, Silver Spring, MD 20993, 301– College Park, MD 20740’’ to ‘‘Food and
holdings at our main campus in Silver 796–2039’’. Drug Administration’s Main Library,
Spring, MD. Consequently, we are • We are revising § 165.110 to update 10903 New Hampshire Ave., Bldg. 2,
making technical amendments to our the library address from ‘‘Center for Third Floor, Silver Spring, MD 20993,
regulations at parts 73, 101, 118, 165, Food Safety and Applied Nutrition’s 301–796–2039’’.
172, 173, 177, 178, 184, 189, 589, and Library, 200 C St. NW., Washington DC’’ • We are revising
tkelley on DSK3SPTVN1PROD with RULES
700 (21 CFR parts 73, 101, 118, 165, to ‘‘Food and Drug Administration’s § 101.83(c)(2)(ii)(A)(2) and
172, 173, 177, 178, 184, 189, 589, and Main Library, 10903 New Hampshire (c)(2)(ii)(B)(2), to remove the words
700) to state that the materials can be Ave., Bldg. 2, Third Floor, Silver Spring, ‘‘Office of Nutritional Products,
found at the FDA Library in Silver MD 20993, 301–796–2039’’. Labeling, and Dietary Supplements,
Spring, MD. We also are updating • We are revising §§ 165.110, Division of Nutrition Science and
certain regulations to reflect the current 172.723, 172.736, 172.804, 172.809, Policy,’’ and in their place add ‘‘Office
VerDate Sep<11>2014 17:35 Feb 02, 2016 Jkt 238001 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 E:\FR\FM\03FER1.SGM 03FER1](https://thefederalregister.org/doc/81_FR_5611/page/1.svg)
![5590 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Rules and Regulations
of Nutrition, Labeling and Dietary 21 CFR Part 589 Food Safety and Applied Nutrition’s
Supplements, Nutrition Programs Staff’’. Animal feeds, Animal foods, Food Library, Harvey W. Wiley Federal
• We are revising § 118.8 to replace additives. Building, 5100 Paint Branch Pkwy.,
‘‘The FDA’’ with ‘‘FDA’’. College Park, MD’’ and adding in its
• We are revising § 173.300 to add the 21 CFR Part 700 place ‘‘Food and Drug Administration’s
words ‘‘Office of Food Additive Safety’’. Cosmetics, Packaging and containers. Main Library, 10903 New Hampshire
• We are revising § 173.340 to remove Therefore, under the Federal Food, Ave., Bldg. 2, Third Floor, Silver Spring,
the words ‘‘Division of Petition Control’’ Drug, and Cosmetic Act and under MD 20993, 301–796–2039’’.
and ‘‘(HFS–215)’’ and in their place authority delegated to the Commissioner
adding ‘‘Office of Food Additive Safety § 101.81 [Amended]
of Food and Drugs and redelegated to
(HFS–200)’’. the Director, Center for Food Safety and ■ 7. Amend § 101.81 as follows:
• We are revising § 173.357 to remove Applied Nutrition, 21 CFR parts 73, 101, ■ a. In paragraphs (c)(2)(ii)(A)
the words ‘‘Division of Petition Control’’ 118, 165, 172, 173, 177, 178, 184, 189, introductory text and (c)(2)(ii)(B)(1) and
and ‘‘(HFS–215)’’ and in their place 589, and 700 are amended as follows: (2) remove ‘‘Center for Food Safety and
adding ‘‘Office of Food Additive Safety Applied Nutrition’s Library, 5100 Paint
(HFS–200)’’. PART 73—LISTING OF COLOR Branch Pkwy., College Park, MD 20740’’
• We are updating §§ 177.1520 and ADDITIVES EXEMPT FROM wherever it appears and add in its place
177.1585 to remove the words ‘‘Office of CERTIFICATION ‘‘Food and Drug Administration’s Main
Premarket Approval’’ and in their place Library, 10903 New Hampshire Ave.,
adding the ‘‘Office of Food Additive ■ 1. The authority citation for 21 CFR Bldg. 2, Third Floor, Silver Spring, MD
Safety’’. part 73 continues to read as follows: 20993, 301–796–2039’’.
Publication of this document Authority: 21 U.S.C. 321, 341, 342, 343, ■ b. In paragraph (c)(2)(ii)(A)(5) remove
constitutes final action of these changes 348, 351, 352, 355, 361, 362, 371, 379e. ‘‘Center for Food Safety and Applied
under the Administrative Procedure Act Nutrition Library, 5100 Paint Branch
(5 U.S.C. 553). These amendments are § 73.165 [Amended] Pkwy., College Park, MD 20740’’ and
merely updating the address of CFSAN ■ 2. Amend § 73.165 in paragraph (b) by add in its place ‘‘Food and Drug
references and the names of CFSAN removing ‘‘Center for Food Safety and Administration’s Main Library, 10903
offices. FDA, therefore, for good cause, Applied Nutrition’s Library, 5100 Paint New Hampshire Ave., Bldg. 2, Third
finds under 5 U.S.C. 553(b)(3)(B) and Branch Pkwy., College Park, MD’’ and Floor, Silver Spring, MD 20993, 301–
(d)(3) that notice and public comment adding in its place ‘‘Food and Drug 796–2039’’.
are unnecessary. Administration’s Main Library, 10903
§ 101.83 [Amended]
New Hampshire Ave., Bldg. 2, Third
List of Subjects 8. Amend § 101.83 in paragraphs
Floor, Silver Spring, MD 20993, 301– ■
21 CFR Part 73 796–2039’’. (c)(2)(ii)(A)(2) and (c)(2)(ii)(B)(2) as
follows:
Color additives, Cosmetics, Drugs, § 73.585 [Amended] ■ a. Remove ‘‘Office of Nutritional
Medical devices. Products, Labeling, and Dietary
■ 3. Amend § 73.585 in paragraph (b) by
21 CFR Part 101 removing ‘‘Center for Food Safety and Supplements, Division of Nutrition
Food labeling, Nutrition, Reporting Applied Nutrition’s Library, 5100 Paint Science and Policy’’ and add in its place
and recordkeeping requirements. Branch Pkwy., College Park, MD’’ and ‘‘Office of Nutrition, Labeling and
adding in its place ‘‘Food and Drug Dietary Supplements, Nutrition
21 CFR Part 118 Administration’s Main Library, 10903 Programs Staff’’.
New Hampshire Ave., Bldg. 2, Third ■ b. Remove ‘‘Center for Food Safety
Egg and egg products, Incorporation
by reference, Recordkeeping Floor, Silver Spring, MD 20993, 301– and Applied Nutrition’s Library, 5100
requirements, Safety. 796–2039’’. Paint Branch Pkwy., College Park, MD
20740’’ wherever it appears and add in
21 CFR Part 165 PART 101—FOOD LABELING its place ‘‘Food and Drug
Beverages, Bottled water, Food grades Administration’s Main Library, 10903
■ 4. The authority citation for 21 CFR New Hampshire Ave., Bldg. 2, Third
and standards, Incorporation by part 101 continues to read as follows:
reference. Floor, Silver Spring, MD 20993, 301–
Authority: 15 U.S.C. 1453, 1454, 1455; 21 796–2039’’.
21 CFR Part 172 U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C.
243, 264, 271. PART 118—PRODUCTION, STORAGE,
Food additives, Reporting and
recordkeeping requirements. AND TRANSPORTATION OF SHELL
§ 101.4 [Amended]
EGGS
21 CFR Part 173 ■ 5. Amend § 101.4 in paragraphs (h)
introductory text and (h)(2) by removing ■ 9. The authority citation for 21 CFR
Food additives.
‘‘Center for Food Safety and Applied part 118 continues to read as follows:
21 CFR Part 177 Nutrition’s Library, 5100 Paint Branch Authority: 21 U.S.C. 321, 331–334, 342,
Food additives, Food packaging. Pkwy., College Park, MD 20740’’ 371, 381, 393; 42 U.S.C. 243, 264, 271.
wherever it appears and adding in its
21 CFR Part 178 place ‘‘Food and Drug Administration’s § 118.8 [Amended]
Food additives, Food packaging. Main Library, 10903 New Hampshire ■ 10. Amend § 118.8 in paragraphs (a)
tkelley on DSK3SPTVN1PROD with RULES
Ave., Bldg. 2, Third Floor, Silver Spring, and (b) as follows:
21 CFR Part 184 MD 20993, 301–796–2039’’. ■ a. Remove ‘‘The FDA’’ wherever it
Food additives. appears and add in its place ‘‘FDA’’.
§ 101.80 [Amended] ■ b. Remove ‘‘Center for Food Safety
21 CFR Part 189 ■ 6. Amend § 101.80 in paragraph and Applied Nutrition’s Library, 5100
Food additives, Food packaging. (c)(2)(iii)(C) by removing ‘‘Center for Paint Branch Pkwy., College Park, MD,
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![Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Rules and Regulations 5591
301–436–2163’’ wherever it appears and PART 172—FOOD ADDITIVES Safety and Applied Nutrition’s Library,
add in its place ‘‘Food and Drug PERMITTED FOR DIRECT ADDITION 5100 Paint Branch Pkwy., College Park,
Administration’s Main Library, 10903 TO FOOD FOR HUMAN MD 20740’’ and adding in its place
New Hampshire Ave., Bldg. 2, Third CONSUMPTION ‘‘Food and Drug Administration’s Main
Floor, Silver Spring, MD 20993, 301– Library, 10903 New Hampshire Ave.,
796–2039’’. ■ 13. The authority citation for 21 CFR Bldg. 2, Third Floor, Silver Spring, MD
part 172 continues to read as follows: 20993, 301–796–2039’’.
PART 165—BEVERAGES Authority: 21 U.S.C. 321, 341, 342, 348,
371, 379e. § 172.804 [Amended]
■ 11. The authority citation for 21 CFR
part 165 continues to read as follows: § 172.155 [Amended] ■ 19. Amend § 172.804 in paragraph
(c)(2) by removing ‘‘Center for Food
Authority: 21 U.S.C. 321, 341, 343, 343–1, ■ 14. Amend § 172.155 in paragraph (c) Safety and Applied Nutrition’s Library,
348, 349, 371, 379e. by removing ‘‘Center for Food Safety Food and Drug Administration, 5100
and Applied Nutrition’s Library, 5100 Paint Branch Pkwy., College Park, MD
§ 165.110 [Amended] Paint Branch Pkwy., College Park, MD 20740’’ and adding in its place ‘‘Food
■ 12. Amend § 165.110 as follows: 20740’’ and adding in its place ‘‘Food and Drug Administration’s Main
■ a. In paragraphs (a)(2)(iv) and (vii), and Drug Administration’s Main Library, 10903 New Hampshire Ave.,
(b)(4)(iii)(E)(7)(iv), and (b)(4)(iii)(I), Library, 10903 New Hampshire Ave.,
Bldg. 2, Third Floor, Silver Spring, MD
remove ‘‘Center for Food Safety and Bldg. 2, Third Floor, Silver Spring, MD
20993, 301–796–2039’’.
Applied Nutrition’s Library, 5100 Paint 20993, 301–796–2039’’.
Branch Pkwy., College Park, MD 20740’’ § 172.809 [Amended]
§ 172.167 [Amended]
wherever it appears and add in its place
■ 15. Amend § 172.167 in paragraph ■ 20. Amend § 172.809 in paragraph (b)
‘‘Food and Drug Administration’s Main
(d)(2) by removing ‘‘Center for Food introductory text by removing ‘‘Center
Library, 10903 New Hampshire Ave.,
Safety and Applied Nutrition’s Library, for Food Safety and Applied Nutrition’s
Bldg. 2, Third Floor, Silver Spring, MD
Food and Drug Administration, 5100 Library, Food and Drug Administration,
20993, 301–796–2039’’.
Paint Branch Pkwy., College Park, MD 5100 Paint Branch Pkwy., College Park,
■ b. In paragraphs (b)(2)(ii) and (b)(3)
20740, 301–436–2163’’ and adding in its MD 20740’’ and adding in its place
introductory text, remove ‘‘Center for ‘‘Food and Drug Administration’s Main
Food Safety and Applied Nutrition’s place ‘‘Food and Drug Administration’s
Main Library, 10903 New Hampshire Library, 10903 New Hampshire Ave.,
Library, 5100 Paint Branch Pkwy., Bldg. 2, Third Floor, Silver Spring, MD
College Park, MD 20740, 301–436– Ave., Bldg. 2, Third Floor, Silver Spring,
MD 20993, 301–796–2039’’. 20993, 301–796–2039’’.
2163’’ wherever it appears and add in
its place ‘‘Food and Drug § 172.723 [Amended] § 172.829 [Amended]
Administration’s Main Library, 10903
■ 16. Amend § 172.723 in paragraph ■ 21. Amend § 172.829 in paragraph (b)
New Hampshire Ave., Bldg. 2, Third
(b)(3) by removing ‘‘Center for Food introductory text by removing ‘‘Center
Floor, Silver Spring, MD 20993, 301–
Safety and Applied Nutrition’s Library, for Food Safety and Applied Nutrition’s
796–2039’’.
Food and Drug Administration, 5100 Library, 5100 Paint Branch Pkwy., Rm.
■ c. In paragraph (b)(4)(i)(C)
Paint Branch Pkwy., College Park, MD 1C–100, College Park, MD 20740’’ and
introductory text, remove ‘‘Center for
20740’’ and adding in its place ‘‘Food adding in its place ‘‘Food and Drug
Food Safety and Applied Nutrition’s
and Drug Administration’s Main Administration’s Main Library, 10903
Library, 200 C St. NW., Washington DC’’
Library, 10903 New Hampshire Ave., New Hampshire Ave., Bldg. 2, Third
and add in its place ‘‘Food and Drug
Bldg. 2, Third Floor, Silver Spring, MD Floor, Silver Spring, MD 20993, 301–
Administration’s Main Library, 10903
20993, 301–796–2039’’. 796–2039’’.
New Hampshire Ave., Bldg. 2, Third
Floor, Silver Spring, MD 20993, 301– § 172.736 [Amended] § 172.833 [Amended]
796–2039.’’ ■ 17. Amend § 172.736 as follows:
■ d. In paragraphs (b)(4)(iii)(E) ■ a. In paragraph (b)(1), remove ‘‘Center ■ 22. Amend § 172.833 in paragraphs
introductory text, (b)(4)(iii)(E)(1)(ii) and for Food Safety and Applied Nutrition’s (b)(2) and (4) by removing ‘‘Center for
(iv), (b)(4)(iii)(E)(11)(i), Library, Food and Drug Administration, Food Safety and Applied Nutrition’s
(b)(4)(iii)(E)(14)(i), and (b)(4)(iii)(F)(20), 5100 Paint Branch Pkwy., College Park, Library, 5100 Paint Branch Pkwy.,
remove ‘‘Center for Food Safety and MD 20740’’ and add in its place ‘‘Food College Park, MD 20740’’ wherever it
Applied Nutrition’s Library, Food and and Drug Administration’s Main appears and adding in its place ‘‘Food
Drug Administration, 5100 Paint Branch Library, 10903 New Hampshire Ave., and Drug Administration’s Main
Pkwy., College Park, MD 20740’’ Bldg. 2, Third Floor, Silver Spring, MD Library, 10903 New Hampshire Ave.,
wherever it appears and add in its place 20993, 301–796–2039’’. Bldg. 2, Third Floor, Silver Spring, MD
‘‘Food and Drug Administration’s Main ■ b. In paragraph (b)(3), remove ‘‘in the 20993, 301–796–2039’’.
Library, 10903 New Hampshire Ave., library at the Center for Food Safety and § 172.864 [Amended]
Bldg. 2, Third Floor, Silver Spring, MD Applied Nutrition, 5100 Paint Branch
20993, 301–796–2039’’. Pkwy., College Park, MD 20740’’ and ■ 23. Amend § 172.864 in paragraph
■ e. In paragraph (b)(5)(ii) introductory add in its place ‘‘at the Food and Drug (a)(3) by removing ‘‘Center for Food
text, remove ‘‘Center for Food Safety Administration’s Main Library, 10903 Safety and Applied Nutrition’s Library,
and Applied Nutrition’s Library, 5100 New Hampshire Ave., Bldg. 2, Third Food and Drug Administration, 5100
tkelley on DSK3SPTVN1PROD with RULES
Paint Branch Pkwy., College Park, MD’’ Floor, Silver Spring, MD 20993, 301– Paint Branch Pkwy., College Park, MD
and add in its place ‘‘Food and Drug 796–2039’’. 20740’’ and adding in its place ‘‘Food
Administration’s Main Library, 10903 and Drug Administration’s Main
New Hampshire Ave., Bldg. 2, Third § 172.785 [Amended] Library, 10903 New Hampshire Ave.,
Floor, Silver Spring, MD 20993, 301– ■ 18. Amend § 172.785 in paragraph Bldg. 2, Third Floor, Silver Spring, MD
796–2039’’. (b)(1) by removing ‘‘Center for Food 20993, 301–796–2039’’.
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![5592 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Rules and Regulations
§ 172.886 [Amended] Administration’s Main Library, 10903 and add in its place ‘‘Food and Drug
■ 24. Amend § 172.886 in paragraph New Hampshire Ave., Bldg. 2, Third Administration’s Main Library, 10903
(c)(2)(iii) by removing ‘‘Center for Food Floor, Silver Spring, MD 20993, 301– New Hampshire Ave., Bldg. 2, Third
Safety and Applied Nutrition’s Library, 796–2039’’. Floor, Silver Spring, MD 20993, 301–
Food and Drug Administration, 5100 796–2039’’.
§ 173.45 [Amended]
Paint Branch Pkwy., College Park, MD § 173.325 [Amended]
20740’’ and adding in its place ‘‘Food ■ 27. Amend § 173.45 in paragraph (a)
and Drug Administration’s Main by removing ‘‘Center for Food Safety ■ 29. Amend § 173.325 in paragraph (h)
Library, 10903 New Hampshire Ave., and Applied Nutrition’s Library, 5100 by removing ‘‘Center for Food Safety
Bldg. 2, Third Floor, Silver Spring, MD Paint Branch Pkwy., College Park, MD and Applied Nutrition’s Library, 5100
20993, 301–796–2039’’. 20740’’ and adding in its place ‘‘Food Paint Branch Pkwy., College Park, MD
and Drug Administration’s Main 20740 20204–0001’’ and adding in its
PART 173—SECONDARY DIRECT Library, 10903 New Hampshire Ave., place ‘‘Food and Drug Administration’s
FOOD ADDITIVES PERMITTED IN Bldg. 2, Third Floor, Silver Spring, MD Main Library, 10903 New Hampshire
FOOD FOR HUMAN CONSUMPTION 20993, 301–796–2039’’. Ave., Bldg. 2, Third Floor, Silver Spring,
■ 25. The authority citation for 21 CFR § 173.300 [Amended] MD 20993, 301–796–2039’’.
part 173 continues to read as follows: ■ 28. Amend § 173.300 in paragraph ■ 30. Amend § 173.340 in the table in
Authority: 21 U.S.C. 321, 342, 348. (a)(2) as follows: paragraph (a)(4) by revising the entry
■ a. Remove ‘‘Center for Food Safety ‘‘n-Butoxypoly(oxyethylene)-
§ 173.25 [Amended] and Applied Nutrition (HFS–200)’’ and poly(oxypropylene)glycol’’ to read as
■ 26. Amend § 173.25 in paragraph add in its place ‘‘Office of Food follows:
(b)(2)(ii)(B) by removing ‘‘Center for Additive Safety (HFS–200), Center for § 173.340 Defoaming agents.
Food Safety and Applied Nutrition’s Food Safety and Applied Nutrition’’.
Library, 5100 Paint Branch Pkwy., ■ b. Remove ‘‘Center for Food Safety
* * * * *
College Park, MD 20740’’ and adding in and Applied Nutrition’s Library, 5100 (a) * * *
its place ‘‘Food and Drug Paint Branch Pkwy., College Park, MD’’ (4) * * *
Substances Limitations
n-Butoxypoly(oxyethylene)-poly(oxypropylene)glycol ............................... Viscosity range, 4,850–5,350 Saybolt Universal Seconds (SUS) at 37.8
°C (100 °F). The viscosity range is determined by the method ‘‘Vis-
cosity Determination of n-butoxypoly(oxyethylene)-
poly(oxypropylene) glycol’’ dated April 26, 1995, developed by Union
Carbide Corp., P.O. Box 670, Bound Brook, NJ 08805, which is in-
corporated by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51. Copies of the material incorporated by reference are
available from the Office of Food Additive Safety (HFS–200), Center
for Food Safety and Applied Nutrition, Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, and may be ex-
amined 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 Administra-
tion (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.
* * * * * * *
* * * * * ‘‘Food and Drug Administration’s Main § 173.357 Materials used as fixing agents
Library, 10903 New Hampshire Ave., in the immobilization of enzyme
§ 173.356 [Amended] Bldg. 2, Third Floor, Silver Spring, MD preparations.
■ 31. Amend § 173.356 in paragraph (a) 20993, 301–796–2039’’. * * * * *
by removing ‘‘Center for Food Safety ■ 32. Amend § 173.357 in the table in
(a) * * *
and Applied Nutrition’s Library, Food paragraph (a)(2) by revising the entry
and Drug Administration, 5100 Paint ‘‘Polyethylenimine reaction product (2) * * *
Branch Pkwy., College Park, MD 20740, with 1,2-dichloroethane (CAS Reg. No.
301–436–2163’’ and adding in its place 68130–97–2)’’ to read as follows:
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![Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Rules and Regulations 5593
Substances Limitations
* * * * * * *
Polyethylenimine reaction product with 1,2-dichloroethane (CAS Reg. May be used as a fixing material in the immobilization of glucoamylase
No. 68130–97–2) is the reaction product of homopolymerization of enzyme preparations from Aspergillus niger for use in the manufac-
ethylenimine in aqueous hydrochloric acid at 100 °C and of cross- ture of beer.
linking with 1,2-dichloroethane. The finished polymer has an average May be used as a fixing material in the immobilization of:
molecular weight of 50,000 to 70,000 as determined by gel perme- 1. Glucose isomerase enzyme preparations for use in the manufacture
ation chromatography. The analytical method is entitled ‘‘Method- of high fructose corn syrup, in accordance with § 184.1372 of this
ology for Molecular Weight Detection of Polyethylenimine,’’ which is chapter.
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 2. Glucoamylase enzyme preparations from Aspergillus niger for use in
CFR part 51. Copies may be obtained from the Office of Food Addi- the manufacture of beer. Residual ethylenimine in the finished
tive Safety (HFS–200), Center for Food Safety and Applied Nutrition, polyethylenimine polymer will be less than 1 part per million as de-
5100 Paint Branch Pkwy., College Park, MD 20740, and may be ex- termined by gas chromatography-mass spectrometry. The residual
amined at the Food and Drug Administration’s Main Library, 10903 ethylenimine is determined by an analytical method entitled ‘‘Meth-
New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, odology for Ethylenimine Detection in Polyethylenimine,’’ which is in-
301–796–2039, or at the National Archives and Records Administra- corporated by reference in accordance with 5 U.S.C. 552(a) and 1
tion (NARA). For information on the availability of this material at CFR part 51. Residual 1,2-dichloroethane in the finished
NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_ polyethylenimine polymer will be less than 1 part per million as de-
register/code_of_federal_regulations/ibr_locations.html. termined by gas chromatography. The residual 1,2-dichloroethane is
determined by an analytical method entitled, ‘‘Methodology for
Ethylenedichloride Detection in Polyethylenimine,’’ which is incor-
porated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies may be obtained from the Office of Food Additive
Safety (HFS–200), Center for Food Safety and Applied Nutrition,
5100 Paint Branch Pkwy., College Park, MD 20740, or may be ex-
amined 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 Administra-
tion (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.
* * * * * Authority: 21 U.S.C. 321, 342, 348, 379e. 20740’’ and adding in its place ‘‘Food
and Drug Administration’s Main
§ 173.370 [Amended] § 177.1345 [Amended]
Library, 10903 New Hampshire Ave.,
■ 33. Amend § 173.370 in paragraph (c) ■ 36. Amend § 177.1345 in paragraph Bldg. 2, Third Floor, Silver Spring, MD
by removing ‘‘Center for Food Safety (b)(1) by removing ‘‘Center for Food 20993, 301–796–2039’’.
and Applied Nutrition’s Library, 5100 Safety and Applied Nutrition’s Library,
Paint Branch Pkwy., College Park, MD Food and Drug Administration, 5100 § 177.1390 [Amended]
20740’’ and adding in its place ‘‘Food Paint Branch Pkwy., College Park, MD ■ 39. Amend § 177.1390 in paragraph
and Drug Administration’s Main 20740’’ and adding in its place ‘‘Food (c)(3)(i)(a)(1) by removing ‘‘Center for
Library, 10903 New Hampshire Ave., and Drug Administration’s Main Food Safety and Applied Nutrition’s
Bldg. 2, Third Floor, Silver Spring, MD Library, 10903 New Hampshire Ave., Library, 5100 Paint Branch Pkwy.,
20993, 301–796–2039’’. Bldg. 2, Third Floor, Silver Spring, MD College Park, MD 20740’’ and adding in
20993, 301–796–2039’’. its place ‘‘Food and Drug
§ 173.375 [Amended]
§ 177.1350 [Amended] Administration’s Main Library, 10903
■ 34. Amend § 173.375 in paragraph (a) New Hampshire Ave., Bldg. 2, Third
by removing ‘‘Center for Food Safety ■ 37. Amend § 177.1350 in paragraph
(b)(2) by removing ‘‘Center for Food Floor, Silver Spring, MD 20993, 301–
and Applied Nutrition’s Library, Food 796–2039’’.
and Drug Administration, 5100 Paint Safety and Applied Nutrition’s Library,
Branch Pkwy., College Park, MD 20740’’ 5100 Paint Branch Pkwy., College Park, ■ 40. Amend § 177.1520 in the table in
and adding in its place ‘‘Food and Drug MD 20740’’ and adding in its place paragraph (b) by revising the entry
Administration’s Main Library, 10903 ‘‘Food and Drug Administration’s Main ‘‘Methyl methacrylate/butyl acrylate-
New Hampshire Ave., Bldg. 2, Third Library, 10903 New Hampshire Ave., grafted polypropylene copolymer
Floor, Silver Spring, MD 20993, 301– Bldg. 2, Third Floor, Silver Spring, MD containing methyl methacrylate/butyl
796–2039’’. 20993, 301–796–2039’’. acrylate-grafted polypropylene (CAS
Reg. No. 121510–09–6)’’ to read as
§ 177.1360 [Amended] follows:
PART 177—INDIRECT FOOD
ADDITIVES: POLYMERS ■ 38. Amend § 177.1360 in paragraph
(d) by removing ‘‘Center for Food Safety § 177.1520 Olefin polymers.
■ 35. The authority citation for 21 CFR and Applied Nutrition’s Library, 5100 * * * * *
part 177 continues to read as follows: Paint Branch Pkwy., College Park, MD (b) * * *
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![5594 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Rules and Regulations
Substance Limitations
* * * * * * *
Methyl methacrylate/butyl acrylate-grafted polypropylene copolymer For use only at levels not to exceed 6 percent by weight of olefin poly-
containing methyl methacrylate/butyl acrylate-grafted polypropylene mers complying with paragraph (c) of this section, items 1.1, 3.1a,
(CAS Reg. No. 121510–09–6), methyl methacrylate/butyl acrylate co- 3.2a, and 3.2b, where the copolymers complying with items 3.1a,
polymer (CAS Reg. No. 25852–37–3), methyl methacrylate 3.2a, and 3.2b contain not less than 85 weight-percent of polymer
homopolymer (CAS Reg. No. 9011–14–7), and polypropylene (CAS units derived from propylene.
Reg. No. 9003–07–0), resulting from the reaction of a mixture of
methyl methacrylate and butyl acrylate with polypropylene. The fin-
ished product contains no more than 55 percent by weight of poly-
mer units derived from methyl methacrylate and butyl acrylate as de-
termined by a method entitled, ‘‘Determination of the Total Acrylic in
PP–MMA/BA Polymers,’’ which is incorporated by reference in ac-
cordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are avail-
able from the Office of Food Additive Safety, Center for Food Safety
and Applied Nutrition (HFS–200), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, or may be ex-
amined 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 Administra-
tion (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.
* * * * * * *
* * * * * Paint Branch Pkwy., College Park, MD Authority: 21 U.S.C. 321, 342, 348, 379e.
20740’’ and adding in its place ‘‘Food
§ 177.1585 [Amended] § 178.1010 [Amended]
and Drug Administration’s Main
■ 41. Amend § 177.1585 in paragraph Library, 10903 New Hampshire Ave., ■ 45. Amend § 178.1010 in paragraph
(c)(1)(i) as follows: Bldg. 2, Third Floor, Silver Spring, MD (c)(40) by removing ‘‘Center for Food
■ a. Remove ‘‘Office of Premarket 20993, 301–796–2039’’. Safety and Applied Nutrition’s Library,
Approval’’ and add in its place ‘‘Office § 177.2600 [Amended]
Food and Drug Administration, 5100
of Food Additive Safety’’. Paint Branch Pkwy., College Park, MD
■ b. Remove ‘‘Center for Food Safety
■ 43. Amend § 177.2600 in paragraph 20740’’ and adding in its place ‘‘Food
and Applied Nutrition’s Library, Food (c)(4)(i) by removing ‘‘Center for Food and Drug Administration’s Main
and Drug Administration, 5100 Paint Safety and Applied Nutrition’s Library, Library, 10903 New Hampshire Ave.,
Branch Pkwy., College Park, MD 20740’’ 5100 Paint Branch Pkwy., College Park, Bldg. 2, Third Floor, Silver Spring, MD
and add in its place ‘‘Food and Drug MD 20740’’ and adding in its place 20993, 301–796–2039’’.
Administration’s Main Library, 10903 ‘‘Food and Drug Administration’s Main
Library, 10903 New Hampshire Ave., § 178.3297 [Amended]
New Hampshire Ave., Bldg. 2, Third
Floor, Silver Spring, MD 20993, 301– Bldg. 2, Third Floor, Silver Spring, MD
■ 46. Amend § 178.3297 in the table in
796–2039’’. 20993, 301–796–2039’’.
paragraph (e) by revising the entry
PART 178—INDIRECT FOOD ‘‘High-purity furnace black (CAS Reg.
§ 177.1637 [Amended]
ADDITIVES: ADJUVANTS, No. 1333–86–4)’’ to read as follows:
■ 42. Amend § 177.1637 in paragraph PRODUCTION AIDS, AND SANITIZERS § 178.3297 Colorants for polymers.
(b)(2) by removing ‘‘Center for Food
Safety and Applied Nutrition’s Library, ■ 44. The authority citation for 21 CFR * * * * *
Food and Drug Administration, 5100 part 178 continues to read as follows: (e) * * *
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![Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Rules and Regulations 5595
Substances Limitations
* * * * * * *
High-purity furnace black (CAS Reg. No. 1333–86–4) containing total For use at levels not to exceed 2.5 percent by weight of the polymer.
polynuclear aromatic hydrocarbons not to exceed 0.5 parts per mil-
lion, and benzo[a]pyrene not to exceed 5.0 parts per billion, as deter-
mined by a method entitled ‘‘Determination of PAH Content of Car-
bon Black,’’ dated July 8, 1994, as developed by the Cabot Corp.,
which is incorporated by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies may be obtained from the Office
of Food Additive Safety (HFS–200), Center for Food Safety and Ap-
plied Nutrition, Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–402–1200, or may be exam-
ined 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_reg-
ister/code_of_federal_regulations/ibr_locations.html.
* * * * * * *
PART 184—DIRECT FOOD and Applied Nutrition’s Library, 5100 and Applied Nutrition’s Library, Food
SUBSTANCES AFFIRMED AS Paint Branch Pkwy., College Park, MD and Drug Administration, 5100 Paint
GENERALLY RECOGNIZED AS SAFE 20740’’ and adding in its place ‘‘Food Branch Pkwy., College Park, MD 20740’’
and Drug Administration’s Main and adding in its place ‘‘Food and Drug
■ 47. The authority citation for 21 CFR Library, 10903 New Hampshire Ave., Administration’s Main Library, 10903
part 184 continues to read as follows: Bldg. 2, Third Floor, Silver Spring, MD New Hampshire Ave., Bldg. 2, Third
Authority: 21 U.S.C. 321, 342, 348, 371. 20993, 301–796–2039’’. Floor, Silver Spring, MD 20993, 301–
796–2039’’.
§ 184.1007 [Amended] § 184.1250 [Amended]
52. Amend § 184.1250 in paragraph § 184.1293 [Amended]
■ 48. Amend § 184.1007 in paragraph ■
(b)(1) by removing ‘‘Center for Food (b) by removing ‘‘Center for Food Safety ■ 56. Amend § 184.1293 in paragraph
Safety and Applied Nutrition’s Library, and Applied Nutrition’s Library, 5100 (b) by removing ‘‘Center for Food Safety
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD and Applied Nutrition’s Library, Food
Paint Branch Pkwy., College Park, MD 20740’’ and adding in its place ‘‘Food and Drug Administration, 5100 Paint
20740’’ and adding in its place ‘‘Food and Drug Administration’s Main Branch Pkwy., College Park, MD 20740’’
and Drug Administration’s Main Library, 10903 New Hampshire Ave., and adding in its place ‘‘Food and Drug
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD Administration’s Main Library, 10903
Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039’’. New Hampshire Ave., Bldg. 2, Third
20993, 301–796–2039’’. Floor, Silver Spring, MD 20993, 301–
§ 184.1257 [Amended] 796–2039.’’
§ 184.1063 [Amended] ■ 53. Amend § 184.1257 in paragraph
(b) by removing ‘‘Center for Food Safety § 184.1311 [Amended]
■ 49. Amend § 184.1063 in paragraphs
(b) introductory text and (b)(8) by and Applied Nutrition’s Library, Food ■ 57. Amend § 184.1311 in paragraph
removing ‘‘Center for Food Safety and and Drug Administration, 5100 Paint (b) by removing ‘‘Center for Food Safety
Applied Nutrition’s Library, 5100 Paint Branch Pkwy., College Park, MD 20740’’ and Applied Nutrition’s library, 5100
Branch Pkwy., College Park, MD 20740’’ and adding in its place ‘‘Food and Drug Paint Branch Pkwy., College Park, MD
wherever it appears and adding in its Administration’s Main Library, 10903 20740’’ and adding in its place ‘‘Food
place ‘‘Food and Drug Administration’s New Hampshire Ave., Bldg. 2, Third and Drug Administration’s Main
Main Library, 10903 New Hampshire Floor, Silver Spring, MD 20993, 301– Library, 10903 New Hampshire Ave.,
Ave., Bldg. 2, Third Floor, Silver Spring, 796–2039’’. Bldg. 2, Third Floor, Silver Spring, MD
MD 20993, 301–796–2039’’. 20993, 301–796–2039.’’
§ 184.1259 [Amended]
§ 184.1148 [Amended] ■ 54. Amend § 184.1259 in paragraph § 184.1387 [Amended]
■ 50. Amend § 184.1148 in paragraph (b)(3) by removing ‘‘Center for Food ■ 58. Amend § 184.1387 in paragraph
(b) by removing ‘‘Center for Food Safety Safety and Applied Nutrition’s Library, (b) by removing ‘‘Center for Food Safety
and Applied Nutrition’s Library, 5100 Food and Drug Administration, 5100 and Applied Nutrition’s Library, 5100
Paint Branch Pkwy., College Park, MD Paint Branch Pkwy., College Park, MD Paint Branch Pkwy., College Park, MD
20740’’ and adding in its place ‘‘Food 20740’’ and adding in its place ‘‘Food 20740’’ and adding in its place ‘‘Food
and Drug Administration’s Main and Drug Administration’s Main and Drug Administration’s Main
Library, 10903 New Hampshire Ave., Library, 10903 New Hampshire Ave., Library, 10903 New Hampshire Ave.,
tkelley on DSK3SPTVN1PROD with RULES
Bldg. 2, Third Floor, Silver Spring, MD Bldg. 2, Third Floor, Silver Spring, MD Bldg. 2, Third Floor, Silver Spring, MD
20993, 301–796–2039’’. 20993, 301–796–2039’’. 20993, 301–796–2039’’.
§ 184.1150 [Amended] § 184.1282 [Amended] § 184.1420 [Amended]
■ 51. Amend § 184.1150 in paragraph ■ 55. Amend § 184.1282 in paragraph ■ 59. Amend § 184.1420 in paragraph
(b) by removing ‘‘Center for Food Safety (b) by removing ‘‘Center for Food Safety (b) by removing ‘‘Center for Food Safety
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![5596 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Rules and Regulations
and Applied Nutrition’s Library, 5100 Food Safety and Applied Nutrition’s PART 589—SUBSTANCES
Paint Branch Pkwy., College Park, MD Library, Food and Drug Administration, PROHIBITED FROM USE IN ANIMAL
20740’’ and adding in its place ‘‘Food 5100 Paint Branch Pkwy., College Park, FOOD OR FEED
and Drug Administration’s Main MD 20740’’ wherever it appears and
Library, 10903 New Hampshire Ave., adding in its place ‘‘Food and Drug ■ 71. The authority citation for 21 CFR
Bldg. 2, Third Floor, Silver Spring, MD Administration’s Main Library, 10903 part 589 continues to read as follows:
20993, 301–796–2039’’. New Hampshire Ave., Bldg. 2, Third Authority: 21 U.S.C. 321, 342, 343, 348,
Floor, Silver Spring, MD 20993, 301– 371.
§ 184.1444 [Amended]
796–2039’’.
■ 60. Amend § 184.1444 in paragraph § 589.2001 [Amended]
(b)(3) by removing ‘‘Center for Food § 184.1979a [Amended]
■ 72. Amend § 589.2001 in paragraph
Safety and Applied Nutrition’s Library, ■ 66. Amend § 184.1979a in paragraphs (b)(1)(vi)(B) by removing ‘‘Center for
5100 Paint Branch Pkwy., College Park, (b)(1) introductory text and (b)(2) by Food Safety and Applied Nutrition’s
MD 20740’’ and adding in its place removing ‘‘Center for Food Safety and Library, 5100 Paint Branch Pkwy.,
‘‘Food and Drug Administration’s Main Applied Nutrition’s Library, Food and College Park, MD 20740’’ and adding in
Library, 10903 New Hampshire Ave., Drug Administration, 5100 Paint Branch its place ‘‘Food and Drug
Bldg. 2, Third Floor, Silver Spring, MD Pkwy., College Park, MD 20740’’ Administration’s Main Library, 10903
20993, 301–796–2039’’. wherever it appears and adding in its New Hampshire Ave., Bldg. 2, Third
§ 184.1472 [Amended] place ‘‘Food and Drug Administration’s Floor, Silver Spring, MD 20993, 301–
Main Library, 10903 New Hampshire 796–2039’’.
■ 61. Amend § 184.1472 in paragraph Ave., Bldg. 2, Third Floor, Silver Spring,
(a)(2)(iii) by removing ‘‘Center for Food MD 20993, 301–796–2039’’. PART 700—GENERAL
Safety and Applied Nutrition’s Library,
Food and Drug Administration, 5100 § 184.1979b [Amended] ■ 73. The authority citation for 21 CFR
Paint Branch Pkwy., College Park, MD part 700 continues to read as follows:
■ 67. Amend § 184.1979b in paragraphs
20740’’ and adding in its place ‘‘Food Authority: 21 U.S.C. 321, 331, 352, 355,
and Drug Administration’s Main (b)(1) introductory text and (b)(2) by
removing ‘‘Center for Food Safety and 361, 362, 371, 374.
Library, 10903 New Hampshire Ave.,
Bldg. 2, Third Floor, Silver Spring, MD Applied Nutrition’s Library, Food and § 700.27 [Amended]
20993, 301–796–2039’’. Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740’’ ■ 74. Amend § 700.27 in paragraph
§ 184.1530 [Amended] wherever it appears and adding in its (a)(6) by removing ‘‘Center for Food
place ‘‘Food and Drug Administration’s Safety and Applied Nutrition’s Library,
■ 62. Amend § 184.1530 in paragraph 5100 Paint Branch Pkwy., College Park,
(b) by removing ‘‘Center for Food Safety Main Library, 10903 New Hampshire
Ave., Bldg. 2, Third Floor, Silver Spring, MD 20740’’ and adding in its place
and Applied Nutrition’s Library, Food ‘‘Food and Drug Administration’s Main
and Drug Administration, 5100 Paint MD 20993, 301–796–2039’’.
Library, 10903 New Hampshire Ave.,
Branch Pkwy., College Park, MD 20740’’ § 184.1979c [Amended] Bldg. 2, Third Floor, Silver Spring, MD
and adding in its place ‘‘Food and Drug 20993, 301–796–2039’’.
Administration’s Main Library, 10903 ■ 68. Amend § 184.1979c in paragraphs
(b)(1) introductory text and (b)(2) by Dated: January 27, 2016.
New Hampshire Ave., Bldg. 2, Third
Floor, Silver Spring, MD 20993, 301– removing ‘‘Center for Food Safety and Leslie Kux,
796–2039’’. Applied Nutrition’s Library, Food and Associate Commissioner for Policy.
Drug Administration, 5100 Paint Branch [FR Doc. 2016–01787 Filed 2–2–16; 8:45 am]
§ 184.1699 [Amended] Pkwy., College Park, MD 20740’’ BILLING CODE 4164–01–P
■ 63. Amend § 184.1699 in paragraph wherever it appears and adding in its
(b) by removing ‘‘Center for Food Safety place ‘‘Food and Drug Administration’s
and Applied Nutrition’s Library, Food Main Library, 10903 New Hampshire POSTAL REGULATORY COMMISSION
and Drug Administration, 5100 Paint Ave., Bldg. 2, Third Floor, Silver Spring,
Branch Pkwy., College Park, MD 20740’’ MD 20993, 301–796–2039’’. 39 CFR Part 3020
and adding in its place ‘‘Food and Drug [Docket Nos. MC2010–21 and CP2010–36]
Administration’s Main Library, 10903 PART 189—SUBSTANCES
New Hampshire Ave., Bldg. 2, Third PROHIBITED FROM USE IN HUMAN
FOOD Update to Product Lists
Floor, Silver Spring, MD 20993, 301–
796–2039’’. AGENCY: Postal Regulatory Commission.
■ 69. The authority citation for 21 CFR ACTION: Final rule.
§ 184.1866 [Amended] part 189 continues to read as follows:
■ 64. Amend § 184.1866 in paragraph Authority: 21 U.S.C. 321, 342, 348, 371, SUMMARY: The Commission is updating
(b) by removing ‘‘Center for Food Safety 381. the product lists. This action reflects a
and Applied Nutrition’s Library, 5100 publication policy adopted by
§ 189.5 [Amended] Commission order. The referenced
Paint Branch Pkwy., College Park, MD
20740’’ and adding in its place ‘‘Food ■ 70. Amend § 189.5 in paragraph (a)(6) policy assumes periodic updates. The
and Drug Administration’s Main by removing ‘‘Center for Food Safety updates are identified in the body of
Library, 10903 New Hampshire Ave., and Applied Nutrition’s Library, 5100 this document. The product lists, which
tkelley on DSK3SPTVN1PROD with RULES
Bldg. 2, Third Floor, Silver Spring, MD Paint Branch Pkwy., College Park, MD is republished in its entirety, includes
20993, 301–796–2039’’. 20740’’ and adding in its place ‘‘Food these updates.
and Drug Administration’s Main DATES: Effective Date: February 3, 2016.
§ 184.1979 [Amended] Library, 10903 New Hampshire Ave., Applicability Dates: August 4, 2015,
■ 65. Amend § 184.1979 in paragraphs Bldg. 2, Third Floor, Silver Spring, MD Competitive International Merchandise
(b)(1) and (2) by removing ‘‘Center for 20993, 301–796–2039’’. Return Service Agreements with Foreign
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Document Created: 2016-02-03 00:40:39
Document Modified: 2016-02-03 00:40:39
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule; technical amendments. | |
| Dates | This rule is effective February 3, 2016. | |
| Contact | Philip L. Chao, Center for Food Safety and Applied Nutrition (HFS-024), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-2112. | |
| FR Citation | 81 FR 5589 | |
| CFR Citation | 21
CFR
101 21 CFR 118 21 CFR 165 21 CFR 172 21 CFR 173 21 CFR 177 21 CFR 178 21 CFR 184 21 CFR 189 21 CFR 589 21 CFR 700 21 CFR 73 | |
| CFR Associated | Food Labeling; Nutrition; Reporting and Recordkeeping Requirements; Egg and Egg Products; Incorporation by Reference; Recordkeeping Requirements; Safety; Beverages; Bottled Water; Food Grades and Standards; Food Additives; Food Packaging; Animal Feeds; Animal Foods; Packaging and Containers; Color Additives; Cosmetics; Drugs and Medical Devices |
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