[Federal Register Volume 68, Number 127 (Wednesday, July 2, 2003)]
[Notices]
[Pages 39575-39577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-16616]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 97F-0284, 88F-0182, 98F-0706, 98F-0391, 97F-0170, 92F-
0315, 99F-4694, 88F-0340, 95F-0021, 99F-0720, 94F-0290, and 00F-1366]


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 12 food additive 
petitions (FAPs) 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 food 
contact notification (FCN) program for food contact substances. The 
requested uses are now the subjects of effective notifications.

FOR FURTHER INFORMATION CONTACT: Sylvia Dodson, Center for Food Safety 
and Applied Nutrition (HFS-275), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 202-418-3087.

SUPPLEMENTARY INFORMATION: In notices published in the Federal 
Register, on the dates indicated in table 1 of this document, FDA 
announced the filing of 12 FAPs. 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 FCNs for review under the agency's new FCN 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substances and that their petitions be withdrawn when the corresponding 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 FCN process. The 
requested uses are now the subjects of effective notifications. The 
corresponding FAPs are now withdrawn

[[Page 39576]]

without prejudice to a future filing (21 CFR 171.7).

             Table 1.--Food Additive Petitions Subsequently Converted to Food Contact Notifications
----------------------------------------------------------------------------------------------------------------
FAP No.\1\ and      FCN      FR Citation and                    21 CFR Section/
  Docket No.      No.\2\          Date            Company            Part            Additive           Use
----------------------------------------------------------------------------------------------------------------
7B4547, 97F-           87   62 FR 37266,       Eastman              175.300      1,4-              In polyester
 0284                       July 11, 1997.     Chemical Co.                       cyclohexanedime   resins
                                                                                  thanol as a       intended for
                                                                                  polyhydric        coatings in
                                                                                  alcohol.          contact with
                                                                                                    food.
----------------------------------------------------------------------------------------------------------------
8B4083, 88F-          106   53 FR 23455,      Dow Chemical          176.170      Styrene-          As components
 0182                        June 22, 1988.    Co.                                butadiene-        of paper and
                                                                                  acrylonitrile     paperboard
                                                                                  copolymers        in contact
                                                                                  copolymerized     with food.
                                                                                  with not more
                                                                                  than 10 percent
                                                                                  of one or more
                                                                                  of the monomers
                                                                                  of acrylic
                                                                                  acid, fumaric
                                                                                  acid, 2-
                                                                                  hydroxyethyl
                                                                                  acrylate,
                                                                                  itaconic acid
                                                                                  and menacrylic
                                                                                  acid.
----------------------------------------------------------------------------------------------------------------
8B4620, 98F-          115    63 FR 45820,      BASF Corp.           178.3297     2,9-bis(3,5-      As a colorant
 0706                       Aug. 27, 1998.                                        dimethylphenyl)   for all
                                                                                  anthra(2,1,9-     polymers
                                                                                  def:6,5,10-d'e'   intended for
                                                                                  f')diisoquinoli   use in
                                                                                  ne-               contact with
                                                                                  1,3,8,10(2H,      food.
                                                                                  9H)-tetrone.
                                                                                  (C.I. Pigment
                                                                                  Red 149).
----------------------------------------------------------------------------------------------------------------
8B4595, 98F-          118   63 FR 32672,      BASF Corp.            178.3297     2,9-bis[4-         As a
 0391                       June 15, 1998.                                        (phenylazo)phen   colorant for
                                                                                  yl]anthra[2,      all polymers
                                                                                  1,9-def:6,5,10-   intended for
                                                                                  d'e'f']diisoqui   use in
                                                                                  noline-           contact with
                                                                                  1,3,8,10(2H,      food.
                                                                                  9H)-tetrone.
                                                                                  (C.I. Pigment
                                                                                  Red 178).
----------------------------------------------------------------------------------------------------------------
7B4538, 97F-          123   62 FR 23467,      Toyo-Morton,          177.1390     Polyester-epoxy-  As a nonfood
 0170                       Apr. 30, 1997.     Ltd. c/o                           urethane          contact
                                               Keller and                         adhesive.         layer of
                                               Heckman, LLP.                                        laminated
                                                                                                    articles
                                                                                                    intended for
                                                                                                    use in
                                                                                                    contact with
                                                                                                    food.
----------------------------------------------------------------------------------------------------------------
2B4337, 92F-          124   57 FR 43740,      Fina Oil and          177.1640     Rubber-modified   In contact
 0315                       Sept. 22, 1992.    Chemical Co.                       polystyrene       with food.
                                                                                  resin
                                                                                  containing not
                                                                                  less than 71
                                                                                  weight percent
                                                                                  of polymer
                                                                                  units derived
                                                                                  from styrene
                                                                                  monomer and
                ..........  ................  ...............       178.2010     octadecyl 3,5-di- As a
                                                                                  tert-butyl-4-     stabilizer
                                                                                  hydroxyhydrocin   in the
                                                                                  namate.           rubber-
                                                                                                    modified
                                                                                                    polystyrene.
----------------------------------------------------------------------------------------------------------------
0B4699, 99F-          131   64 FR 61132,      Rohm and Haas         175.105 and  2-methyl-4-       As an
 4694                       Nov. 9, 1999.      Co.                  176.170.      isothiazolin-3-   antimicrobia
                                                                                  one.              l additive
                                                                                                    for
                                                                                                    adhesives,
                                                                                                    paper
                                                                                                    additives,
                                                                                                    and paper
                                                                                                    coatings
                                                                                                    that are
                                                                                                    intended to
                                                                                                    contact
                                                                                                    food.
----------------------------------------------------------------------------------------------------------------
8B4105, 88F-          146   53 FR 43272,      Shell Oil Co.         177.1570     Poly-1-butene     As articles
 0340                       Oct. 26, 1988.                                        resins and        or
                                                                                  butene/ethylene   components
                                                                                  copolymers        of articles
                                                                                  containing no     intended for
                                                                                  more than 6-      food-contact
                                                                                  weight-percent    use.
                                                                                  ethylene.
----------------------------------------------------------------------------------------------------------------

[[Page 39577]]

 
5B4444, 95F-          151   60 FR 7974,       M & G Ricerche        177.1630     Ethylene          In contact
 0021                       Feb. 10, 1995.     S.p.A.                             terephthalate-    with food.
                                                                                  isophthalate
                                                                                  copolymers
                                                                                  prepared with
                                                                                  pyromellitic
                                                                                  dianhydride
                                                                                  such that the
                                                                                  finished
                                                                                  copolymers
                                                                                  contain at
                                                                                  least 95 weight
                                                                                  percent of
                                                                                  polymer units
                                                                                  derived from
                                                                                  ethylene
                                                                                  terephthalate.
----------------------------------------------------------------------------------------------------------------
9B4653, 99F-          166   64 FR 16742,      Arakawa               178          Hydrogenated      In blends
 0720                       Apr. 6, 1999.      Chemical                           aromatic          with
                                               Industries,                        petroleum         polymers
                                               Ltd. c/o                           hydrocarbon       intended for
                                               Keller and                         resins.           contact with
                                               Heckman, LLP.                                        food.
----------------------------------------------------------------------------------------------------------------
4B4427, 94F-          179   59 FR 43847,      Eastman               177.1315     Ethylene-1,4-     As components
 0290                       Aug. 25, 1994.     Chemical Co.                       cyclohexylene     of articles
                                                                                  dimethylene       for food
                                                                                  terephthalate     contact use.
                                                                                  copolymers that
                                                                                  include 1 to
                                                                                  100 mole
                                                                                  percent of
                                                                                  repeat units
                                                                                  derived from
                                                                                  1,4-
                                                                                  cyclohexylene
                                                                                  dimethylene
                                                                                  terephthalate.
----------------------------------------------------------------------------------------------------------------
0B4713, 00F-          220   65 FR 41079,      Nippon Shokubai       177.1520     Methylmethacryla   Intended for
 1366                       July 3, 2000.      c/o Keller and                     te-               use in
                                               Heckman, LLP.                      trimethylolprop   contact with
                                                                                  ane               food.
                                                                                  trimethacrylate
                                                                                  copolymer as an
                                                                                  antiblocking
                                                                                  agent in linear
                                                                                  low-density
                                                                                  polyethylene.
----------------------------------------------------------------------------------------------------------------
\1\ Food Additive Petition Number.
\2\ Food Contact Notification Number.


    Dated: June 17, 2003.
Laura M. Tarantino
Deputy Director, Office of Food Additive Safety, Center for Food Safety 
and Applied Nutrition.
[FR Doc. 03-16616 Filed 7-1-03; 8:45 am]
BILLING CODE 4160-01-S