[Federal Register Volume 65, Number 131 (Friday, July 7, 2000)]
[Notices]
[Pages 42014-42017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17199]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 95F-0092, 95F-0129, 95F-0130, 97F-0175, 97F-0406, 97F-
0414, 98F-0053, 98F-0058, 98F-0436, 98F-0714, 98F-1021, 99F-0804, 99F-
1419, 99F-2080, 99F-2552, 99F-2908, 99F-2997, 99F-2998, and 99F-4373]


Withdrawal of Food Additive Petitions Subsequently Converted to 
Food Contact Notifications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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

[[Page 42015]]

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withdrawn when the corresponding notifications become effective.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now withdrawn without prejudice to a future filing (21 CFR 171.7).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
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  FAP No.\1\ and
    Docket No.     FCN No.\2\    FR Citation and Date           Company            Section/Part                 Additive                     Use
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9B4662,            1           64 FR 28000,              Milliken & Co. c/o    Proposed new section  Silver sodium hydrogen         Antimicrobial for
99F-1419                       May 24, 1999               Keller & Heckman.     in part 178.          zirconium phosphate             polymers for food
                                                                                                                                     packaging.
8B4632,            3           63 FR 67075,              Rohm and Haas Co. c/  176.170               Styrene acrylic copolymers     Paper and paperboard
98F-1021                       Dec. 4,1998                o Keller & Heckman.                                                        coating.
8B4564,            5           63 FR 5808,               Currently, BP Amoco   177.1480              Nitrile rubber modified        Beverage containers.
98F-0053                       Feb. 4, 1998                Chemicals, Inc.                            acrylonitrile-methyl
                                                                                                       acrylate copolymers.
5B4455,            4           60 FR 22400,              Currently, BP Amoco   177.1630              Ethylene terephthalate-        Components of food-
95F-0092                       May 5, 1995                 Chemicals, Inc.                            isophthalate copolymers        contact
                                                                                                       with 83-97 weight percent    articles.
                                                                                                       ethylene terephthalate
                                                                                                      units.
5B4450,            8           60 FR 32526,              Shell Chemicals Co.   177.1630              Ethylene terephthalate         Components of food-
95F-0130                       June 22, 1995                                                          polymers containing less       contact
                                                                                                       than 50 weight percent of      articles.
                                                                                                      polymer units derived from
                                                                                                      ethylene 2,6-naphthalene.
5B4451,            9           60 FR 32159,              Shell Chemicals Co.   Proposed new section  Poly(oxy-1,2-                  Components of food-
95F-0129                       June 20, 1995                                    in part 177.          ethanediyloxycarbonyl-2,6-     contact
                                                                                                       napthalenediylcarbonyl)      articles.
                                                                                                      polymer and the copolymer
                                                                                                      poly(oxy-1,2-ethanediyloxy
                                                                                                       carbonyl-2,6-
                                                                                                      naphthalenediylcarbonyl)
                                                                                                      with ethylene terephthalate.
8B4582, 98F-0058   10          63 FR 6571,               Currently, Sekisui    177.1630              Pyromellitic dianhydride       Modifier in ethylene
                               Feb. 9, 1998               Plastics Co., Ltd.                                                          terephthalate.
                                                          c/o Ungaretti &                                                            copolymers.
                                                           Harris.
7B4558,            12          62 FR 51873,              Sveriges              178.3520              Industrial starch modified     Component of food-
97F-0406                       Oct. 3, 1997               Starkelseproducente                         with up to 21 percent          contact articles.
                                                          r c/o Kirschman                              2,3-epoxypropyltrimethyl
                                                          Assoc.                                      ammonium chloride.
9B4685,            19          64 FR 47843,              The Goodyear Tire &   175.300               Piperylene/2-methyl-2-butene/  Can end cement.
99F-2908                       Sept. 1, 1999               Rubber Co. c/o                              alpha-methylstyrene
                                                          Keller & Heckman.                           terpolymer.
9B4645, 99F-0804   11          64 FR 19182,              Rohm and Haas Co.     176.170 and           4,5-Dichloro-2-n-octyl 3 (2H)- Preservative and
                               Apr. 19, 1999                                     176.300.             isothiazolone                   slimicide for
                                                                                                                                     paper and
                                                                                                                                     paperboard.

[[Page 42016]]

 
7B4554,            15          62 FR 52137,              Stilbene Whitening    176.170               Benzenesulfonic acid, 2,2-     Optical brightner in
97F-0414                       Oct. 6, 1997               Agent Task Force c/                         (1,2-ethenediyl)bis[5-         paper and
                                                          o Keller & Heckman.                          [[4-[bis(2-hydroxyethyl)-     paperboard.
                                                                                                      amino]-6-
                                                                                                       [(4-sulfonphenyl)amino]-
                                                                                                      1,3,5-triazin-2-
                                                                                                       yl]amino]-,tetrasodium
                                                                                                      salt.
8B4617,            20          63 FR 46226,              Asahi Denka Kogyo,    178.2010              2,2'-methylenebis(4,6-di-tert- Antioxidant and/or
98F-0714                       Aug. 31, 1998              K.K. c/o Japan                              butylphenyl)2-                  stabilizer in
                                                          Technical                                    ethylhexyl phosphite.         linear low density
                                                          Information Center,                                                        polyethylene.
                                                          Inc.
8B4599,            21          63 FR 34188,              Asahi Denka Kogyo,    178.2010              2,2'-methylenebis(4,6-di-tert- Antioxidant and/or
98F-0436                       June 23, 1998              K.K. c/o Japan                              butylphenyl)2                  stabilizer in high
                                                          Technical                                    -ethylhexyl phosphite.        density
                                                          Information Center,                                                        polyethylene.
                                                          Inc.
9B4679,            22          64 FR 43189,              Asahi Denka Kogyo,    178.2010              Phosphorous acid, cyclic       Antioxidant and/or
99F-2552                       Aug. 9, 1999               K.K. c/o Japan                              neopentanetetrayl              stabilizer in
                                                          Technical                                    bis(2,6-di-tert-butyl-4-      polyolefins.
                                                          Information Center,                         methylphenyl) ester.
                                                          Inc.
9B4667,            23          64 FR 36361,              Engelhard Corp.       178.3297              Solution of 1-                 Colorant for
99F-2080                       July 6, 1999                                                           naphthalenesulfonic acid,      polymers.
                                                                                                       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).
7A4541,            30          62 FR 25633,              Currently, Betz       173.310               Copolymer of acrylic acid and  Boiler water
97F-0175                       May 9, 1997                Dearborn c/o Keller                          polyethylen eglycol allyl     additive.
                                                          and Heckman                                 ether.
9B4694,            29          64 FR 48654,              Asahi Denka Kogyo,    178.2010              Tridecanol phosphite           Antioxidant and/or
99F-2998                       Sept. 7, 1999              K.K.                                        condensation product            stabilizer in
                                                                                                       with butylidenebis[2-(1,1-    styrene-isoprene-
                                                                                                       dimethylethyl)- 5-methyl-     styrene copolymer
                                                                                                      4,1-phenylene].                to be used as a
                                                                                                                                     component of
                                                                                                                                     pressure-sensitive
                                                                                                                                     adhesives.
9B4691,            25          64 FR 49496,              Engelhard Corp.       178.3297              1-naphthelenesulfonic acid, 2- Colorant for
99F-2997                       Sept. 13, 1999                                                         [(4,5-dihydro-3-methyl- 5-     polymers.
                                                                                                      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).
9B4698,            26          64 FR 58070,              Engelhard Corp.       178.3297              A solid solution of 2-         Colorant for
99F-4373                       Oct. 28, 1999                                                          naphthalene sulfonic acid,     polymers.
                                                                                                       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).
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\1\ Food additive petition number.
\2\ Food-contact notification number.



[[Page 42017]]

    Dated: June 28, 2000.
Alan M. Rulis,
Director, Office of Premarket Approval, Center for food Safety and 
Applied Nutrition.
[FR Doc. 00-17199 Filed 7-6-00; 8:45 am]
BILLING CODE 4160-01-F