00-30326. Withdrawal of Food Additive Petitions Subsequently Converted to Food Contact Notifications

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of 18 food additive petitions proposing that the food additive regulations be amended to provide for the safe use of certain new food additives. The petitioners subsequently requested that their petitions be converted to food-contact notifications for review under the agency’s new premarket notification (PMN) program for food-contact substances. The requested uses are now the subjects of effective notifications.

FOR FURTHER INFORMATION CONTACT:

Sylvia D. Dodson, Center for Food Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3087.

SUPPLEMENTARY INFORMATION:

In notices published in the Federal Register on the dates indicated in the table below, FDA announced the filing of 18 food additive petitions. These petitions proposed to amend the food additive regulations in the sections listed in the table to provide for the safe use of the listed substances intended for use in food-contact articles. Since publication of these filing notices, the petitioners have requested that their respective petitions be converted to food-contact notifications for review under the agency’s new PMN process for food-contact substances and that their petitions be withdrawn when the corresponding notifications become effective. These petitions were converted to notifications and subsequently reviewed under the PMN process. The requested uses are now the subjects of effective notifications. The corresponding food additive petitions are now withdrawn without prejudice to a future filing (21 CFR 171.7).

Table 1.

FAP No.1 and Docket No.	FNC No.2	FR Citation and Date	Company	Section/Part	Additive	Use
3B4354, 93F-0199	28	59 FR 59410, Nov. 17, 1994	Asahi Chemical Industry Co., Ltd., c/o Regulatory Assistance Corp.	175.105 and 177.1810	Maleic anhydride modified hydrogenated styrene butadiene block polymer.	Not Specified.
7A4539, 98F-0226	31	63 FR 18921, Apr. 16, 1998	Nalco Chemical Co.	173.310	Disodium or dipotassium fluorescein.	In boilers where steam may contact food.
8B4569, 98F-0289	34	63 FR 25864, May 11, 1998	UBE Industries, Ltd., c/o Center for Regulatory Services.	177.1500	Nylon 6/12 copolymer resins manufactured using at least 80 weight percent epsilon-caprolactam and no more than 20 weight percent omega-aminododecanoic acid.	In contact with food.
0B4204, 90F-0188	44	55 FR 26264, June 27, 1990	Toyobo Co., Ltd.	177.1630	Hexanedioic acid polymer with 1,3-benzenedimethanamine.	Modifier for polyethylene phthalate (PET) polymers.
9A4659, 99F-1074	45	64 FR 23337, Apr. 30, 1999	Life Technologies, Inc.	173.25	Quaternary amine cellulose ion exchange resins.	Isolation and purification of protein concentrates and isolates from aqueous process streams for food processing.
6B4488, 96F-0032	47	61 FR 5001, Feb. 2, 1996	Shinagawa Fuel Co., Ltd., c/o Keller and Heckman.	Proposed new section in part 178.	Silver-zinc zeolite.	Agent to control the growth of microorganisms in plastic resins used in food-contact applications.
0B4702, 00F-0089	51	65 FR 1908, Jan. 12, 2000	Ciba Specialty Chemicals Corp.	178.2010	Phosphorous acid, bis[2,4-bis(1,1-dimethyl)-6-methylphenyl]ethyl ester.	Stabilizer in olefin polymers intended to contact food.
0B4700, 99F-5012	53	64 FR 66480, Nov. 26, 1999	Ciba Specialty Chemicals Corp.	178.2010	Oxidized bis (hydrogenated tallow alkyl) amines.	Process stabilizer for certain olefin polymers intended for use in contact with food.
6B4506, 96F-0223	54	61 FR 35770, July 8, 1996	Henkel Corp.	Proposed new section in part 176.	α-Sulfo-­-(dodecyloxy)­poly­(oxyethylene), sodium salt.	An emulsifier in the production of acrylic and vinyl acetate polymers coatings for paper and paperboard.
9A4677, 99F-2244	55	64 FR 37984, July 14, 1999	Bayer Corp., c/o ENVIRON International Corp.	173.25	Terpolymer of styrene, divinyl benzene, and ethylvinyl benzene, aminomethylated, then quarternized with methyl chloride.	As an ion exchange resin for use in treating aqueous solutions of sugar and hydrolyzed starch.
5B4448, 95F-0011	63	60 FR 7060, Feb. 6, 1995	Kuraray International Co.	177.1810	Styrene block copolymer with 2-methyl-1,3-butadiene and 1,3-butadiene, hydrogenated.	As a component of articles that contact food.
3B3677, 82F-0349	64	47 FR 56556, Dec. 17, 1982	Calgon Corp.	176.170	Diallyldimethylammonium chloride and acrylamide.	As a retention and/or drainage aid employed in the manufacture of paper and paperboard intended to contact food.
9B4646, 99F-0460	67	64 FR 13430, Mar. 18, 1999	Akzo Nobel Chemicals, Inc., c/o Keller and Heckman.	177.1520 and 177.2600	3,6,9-Triethyl-3,6,9-trimethyl-1,4,7-triperoxynonane.	As a modifier in the production of olefin polymers used as components of food-contact articles.
8B4590, 98F-0288	68	63 FR 25213, May 7, 1998	Mitsui Chemicals, Inc., c/o Keller and Heckman	177.1520	Propylene/butene-1 copolymers containing greater than 15 but no more than 35 weight percent of polymer units derived from butene-1.	In contact with food.
1B4256, 91F-0169	69	56 FR 32435, July 16, 1991	W. R. Grace, Ltd.	175.300	Styrene-butadiene-methacrylic acid terpolymer, 1,2-benzisothiazolin-3-one, and sulfosuccinic acid 4-ester with polyethylene glycol dodecyl ether, disodium salt.	Components in can end cements in contact with food.
3B4373, 93F-0157	70	58 FR 29231, May 19, 1993	Shell Oil Co.	Proposed new section.	Two carbon monoxide-olefin polymers, carbon monoxide-ethylene, and carbon monoxide-ethylene-propylene.	As articles or components of articles intended for use in contact with food.
9A4640, 99F-0052	74	64 FR 3703, Jan. 25, 1999	Bayer Corp., c/o ENVIRON Corp.	173.25	Completely hydrolyzed tetrapolymer of divinyl benzene, ethyl vinyl benzene, acrylonitrile, and 1, 7-octadiene.	In treating aqueous sugar solutions and beverage water.
9B4672, 99F-2245	83	64 FR 37984, July 14, 1999	BP Amoco Chemicals, Inc.	Proposed new section in part 177.	Poly(oxy[1,1′-biphenyl]-4,4′-diyloxy-1,4-phenylenesulfonyl-1,4-phenylene) prepared by reaction of biphenol and 4,4′-dichlorodiphenylsulfone.	As articles or components of articles intended for contact with food.
1 Food additive petition number.
2  Food contact notification number.

October 25, 2000.

Alan M. Rulis,

Director, Office of Premarket Approval, Center for Food Safety and Applied Nutrition.