00-17199. 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 19 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:

Mark Hepp, Center for Food Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3098.

SUPPLEMENTARY INFORMATION:

In notices published in the Federal Register (FR), on the dates indicated in the table below, FDA announced the filing of 19 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notifications for review under the agency's new PMN process for food-contact substances and that their petitions be withdrawn when the corresponding notifications become effective.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 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 The corresponding food additive petitions are now withdrawn without prejudice to a future filing (21 CFR 171.7).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.	FCN No.2	FR Citation and Date	Company	Section/Part	Additive	Use
9B4662, 99F-1419	1	64 FR 28000, May 24, 1999	Milliken & Co. c/o Keller & Heckman.	Proposed new section in part 178.	Silver sodium hydrogen zirconium phosphate	Antimicrobial for  polymers for food packaging.
8B4632, 98F-1021	3	63 FR 67075, Dec. 4,1998	Rohm and Haas Co. c/o Keller & Heckman.	176.170	Styrene acrylic copolymers	Paper and paperboard coating.
8B4564, 98F-0053	5	63 FR 5808, Feb. 4, 1998	Currently, BP Amoco  Chemicals, Inc.	177.1480	Nitrile rubber modified acrylonitrile-methyl  acrylate copolymers.	Beverage containers.
5B4455, 95F-0092	4	60 FR 22400, May 5, 1995	Currently, BP Amoco  Chemicals, Inc.	177.1630	Ethylene terephthalate-isophthalate copolymers  with 83-97 weight percent  ethylene terephthalate units.	Components of food-contact articles.
5B4450, 95F-0130	8	60 FR 32526, June 22, 1995	Shell Chemicals Co.	177.1630	Ethylene terephthalate polymers containing less  than 50 weight percent of polymer units derived from ethylene 2,6-naphthalene.	Components of food-contact  articles.
5B4451, 95F-0129	9	60 FR 32159, June 20, 1995	Shell Chemicals Co.	Proposed new section in part 177.	Poly(oxy-1,2-ethanediyloxycarbonyl-2,6-  napthalenediylcarbonyl) polymer and the copolymer poly(oxy-1,2-ethanediyloxy  carbonyl-2,6-naphthalenediylcarbonyl) with ethylene terephthalate.	Components of food-contact articles.
8B4582, 98F-0058	10	63 FR 6571, Feb. 9, 1998	Currently, Sekisui Plastics Co., Ltd. c/o Ungaretti &  Harris.	177.1630	Pyromellitic dianhydride	Modifier in ethylene  terephthalate. copolymers.
7B4558, 97F-0406	12	62 FR 51873, Oct. 3, 1997	Sveriges Starkelseproducenter c/o Kirschman Assoc.	178.3520	Industrial starch modified with up to 21 percent  2,3-epoxypropyltrimethyl ammonium chloride.	Component of food-contact articles.
9B4685, 99F-2908	19	64 FR 47843, Sept. 1, 1999	The Goodyear Tire &  Rubber Co. c/o Keller & Heckman.	175.300	Piperylene/2-methyl-2-butene/  alpha-methylstyrene terpolymer.	Can end cement.
9B4645, 99F-0804	11	64 FR 19182, Apr. 19, 1999	Rohm and Haas Co.	176.170 and  176.300.	4,5-Dichloro-2-n-octyl 3 (2H)-isothiazolone	Preservative and  slimicide for paper and paperboard.
7B4554, 97F-0414	15	62 FR 52137, Oct. 6, 1997	Stilbene Whitening Agent Task Force c/o Keller & Heckman.	176.170	Benzenesulfonic acid, 2,2-(1,2-ethenediyl)bis[5-  [[4-[bis(2-hydroxyethyl)-amino]-6-  [(4-sulfonphenyl)amino]-1,3,5-triazin-2-  yl]amino]-,tetrasodium salt.	Optical brightner in paper and paperboard.
8B4617, 98F-0714	20	63 FR 46226, Aug. 31, 1998	Asahi Denka Kogyo, K.K. c/o Japan Technical Information Center, Inc.	178.2010	2,2′-methylenebis(4,6-di-tert-butylphenyl)2-  ethylhexyl phosphite.	Antioxidant and/or  stabilizer in linear low density polyethylene.
8B4599, 98F-0436	21	63 FR 34188, June 23, 1998	Asahi Denka Kogyo, K.K. c/o Japan Technical Information Center, Inc.	178.2010	2,2′-methylenebis(4,6-di-tert-butylphenyl)2  -ethylhexyl phosphite.	Antioxidant and/or stabilizer in high density polyethylene.
9B4679, 99F-2552	22	64 FR 43189, Aug. 9, 1999	Asahi Denka Kogyo, K.K. c/o Japan Technical Information Center, Inc.	178.2010	Phosphorous acid, cyclic neopentanetetrayl  bis(2,6-di-tert-butyl-4-methylphenyl) ester.	Antioxidant and/or stabilizer in polyolefins.
9B4667, 99F-2080	23	64 FR 36361, July 6, 1999	Engelhard Corp.	178.3297	Solution of 1-naphthalenesulfonic acid,  12-[(2-hydroxy-6-sulfo-1-  naphthalenyl)azo]-, strontium salt (1:1) and 2-naphthalenesulfonic acid, 5-  [4-chloro-5-ethyl- 2-sulfophenyl)azo]-6-hydroxy-, strontium salt (1:1) (C.I.  Pigment Red 277).	Colorant for polymers.
7A4541, 97F-0175	30	62 FR 25633, May 9, 1997	Currently, Betz Dearborn c/o Keller and Heckman	173.310	Copolymer of acrylic acid and  polyethylen eglycol allyl ether.	Boiler water additive.
9B4694, 99F-2998	29	64 FR 48654, Sept. 7, 1999	Asahi Denka Kogyo, K.K.	178.2010	Tridecanol phosphite condensation product  with butylidenebis[2-(1,1-  dimethylethyl)- 5-methyl-4,1-phenylene].	Antioxidant and/or  stabilizer in styrene-isoprene-styrene copolymer to be used as a component of pressure-sensitive adhesives.
9B4691, 99F-2997	25	64 FR 49496, Sept. 13, 1999	Engelhard Corp.	178.3297	1-naphthelenesulfonic acid, 2-[(4,5-dihydro-3-methyl- 5-oxo-1-(3-  Sulfophenyl)-1H-pyrazol-4- yl)azo]-,  strontium and calcium salt (1:1)(C.I.  Pigment 209 and C.I. Pigment 209:1).	Colorant for polymers.
9B4698, 99F-4373	26	64 FR 58070, Oct. 28, 1999	Engelhard Corp.	178.3297	A solid solution of 2-naphthalene sulfonic acid,  15-[(5-chloro-4-methyl-2-  sulfophenyl)azo]- 6-hydroxy]-, strontium salt (1:1) and 2-naphthalenesulfonic  acid, 5-[(4-chloro-5-ethyl-2-sulfonphenyl)azo]-6- hydroxy]-,strontium salt  (1:1)(C.I. Pigment Red 276).	Colorant for polymers.
1 Food additive petition number.
2 Food-contact notification number.

Dated: June 28, 2000.

Alan M. Rulis,

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