[Federal Register Volume 64, Number 247 (Monday, December 27, 1999)]
[Rules and Regulations]
[Pages 72274-72275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33394]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 99F-1457]


Indirect Food Additives: Adjuvants, Production Aids, and 
Sanitizers

AGENCY: Food and Drug Administration, HHS.

ACTION: Final Rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the safe use of 4,5-dichloro-2-((5-
hydroxy-3-methyl-1-(3-sulfophenyl)-1H-pyrazol-4-yl)azo)benzenesulfonic 
acid, calcium salt(1:1), (C.I. Pigment Yellow 183) as a colorant in 
high density polyethylene and polypropylene resins intended for use in 
contact with food. This action responds to a petition filed by BASF 
Corp.

DATES: This regulation is effective December 27, 1999. Submit written 
objections and requests for a hearing by January 26, 2000.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Vir D. Anand, Center for Food Safety 
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3081.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of May 27, 1999 (64 FR 28825), FDA announced that a food 
additive petition (FAP 9B4664) had been filed by BASF Corp., 3000 
Continental Dr. North, Mt. Olive, NJ 07828-1234. The petition proposed 
to amend the food additive regulations to provide for the safe use of 
4,5-dichloro-2-((4,5-dihydro-3-methyl-5-oxo-1-(3-sulfophenyl)-1H-
pyrazol-4-yl)azo)benzenesulfonic acid, calcium salt(1:1), (C.I. Pigment 
Yellow 183) as a colorant in high density polyethylene and 
polypropylene resins intended for use in contact with food.
     During review of the petition, it was determined that the colorant 
exists in two tautomeric forms: Keto and enol. As indicated by its 
infrared spectrum, the colorant exists chiefly in its enol form. It was 
decided, therefore, that the colorant (C.I. Pigment Yellow 183) should 
be identified in the regulation by the enol nomenclature and the CAS 
number. The colorant is listed, accordingly, in the codified section of 
this document as 4,5-dichloro-2-((5-hydroxy-3-methyl-1-(3-sulfophenyl)-
1H-pyrazol-4-yl)azo)benzenesulfonic acid, calcium salt(1:1), (C.I. 
Pigment Yellow 183, CAS Reg. No. 65212-77-3).
     FDA has evaluated the data in the petition and other relevant 
material. Based on this information, the agency concludes that: (1) The 
proposed use of the additive is safe, (2) the additive will achieve its 
intended technical effect, and therefore, (3) that the regulations in 
Sec. 178.3297 should be amended as set forth below.
     In accordance with Sec. 171.1(h), the petition and the documents 
that FDA considered and relied upon in reaching its decision to approve 
the petition are available for inspection at the Center for Food Safety 
and Applied Nutrition (address above) by appointment with the 
information contact person listed above. As provided in 21 CFR 
171.1(h), the agency will delete from the documents any materials that 
are not available for public disclosure before making the documents 
available for inspection.
     The agency has previously considered the environmental effects of 
this rule as announced in the notice of filing for FAP 9B4664 (64 FR 
28825, May 27, 1999). No new information or comments have been received 
that would affect the agency's previous determination that there is no 
significant impact on the human environment and that an environmental 
impact statement is not required.
     This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.
     Any person who will be adversely affected by this regulation may 
at anytime on or before January 26, 2000 file with the Dockets 
Management Branch (address above) written objection thereto. Each 
objection shall be separately numbered, and each numbered objection 
shall specify with particularity the provisions of the regulation to 
which objection is made and the grounds for the objection. Each 
numbered objection on which a hearing is requested shall specifically 
so state. Failure to request a hearing for any particular objection 
shall constitute a waiver of the right to a hearing on that objection. 
Each numbered objection for which a hearing is requested shall include 
a detailed analysis of the specific factual information intended to be 
presented in support of the objection in the event that a hearing is 
held. Failure to include such a description and analysis for any 
particular objection shall constitute a waiver of the right to a 
hearing on the objection. Three copies of all documents shall be 
submitted and shall be identified with the docket number found in 
brackets in the

[[Page 72275]]

heading of this document. Any objection received in response to the 
regulation may be seen in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

 List of Subjects in 21 CFR Part 178

     Food additives, Food packaging.
     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 part 178 is amended as follows:

 PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND 
SANITIZERS

     1. The authority citation for 21 CFR part 178 continues to read as 
follows:
    Authority: 21 U.S.C. 321, 342, 348, 379e.
     2. Section 178.3297 is amended in the table in paragraph (e) by 
alphabetically adding an entry under the headings ``Substances'' and 
``Limitations'' to read as follows:


Sec. 178.3297   Colorants for polymers.

* * * * *
     (e) * * *

 
------------------------------------------------------------------------
             Substances                          Limitations
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  *                    *                    *                    *
                   *                    *                    *
 4,5-Dichloro-2-((5-hydroxy-3-       For use only:
 methyl-1-(3-sulfophenyl)-1H-         1. At levels not to exceed 1
 pyrazol-4-  yl)azo)benzenesulfonic   percent by weight of polypropylene
 acid, calcium salt(1:1), (C.I.       polymers and copolymers complying
 Pigment Yellow 183, CAS Reg. No.     with Sec.  177.1520(c) of this
 65212-77-3).                         chapter, items 1.1a, 1.1b, 1.2,
                                      1.3, 3.1a, 3.1b, 3.1c, 3.2a, 3.2b,
                                      3.4, or 3.5. The finished articles
                                      are to contact food only under
                                      conditions of use E through G, as
                                      described in Table 2 of Sec.
                                      176.170(c) of this chapter.
                                     2. At levels not to exceed 1
                                      percent by weight of high density
                                      polyethylene polymers and
                                      copolymers complying with Sec.
                                      177.1520(c) of this chapter, items
                                      2.1, 2.2, 2.3, 3.1a, 3.1b, 3.1c,
                                      3.2a, 3.2b, 3.6 (density not less
                                      than 0.94 grams per cubic
                                      centimeter), or 5. The finished
                                      articles are to contact food only
                                      under conditions of use E through
                                      G, as described in Table 2 of Sec.
                                       176.170(c) of this chapter.
  *                    *                    *                    *
                   *                    *                    *
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    Dated: December 17, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 99-33394 Filed 12-23-99; 8:45 am]
BILLING CODE 4160-01-F