[Federal Register Volume 64, Number 225 (Tuesday, November 23, 1999)]
[Rules and Regulations]
[Pages 65657-65658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30523]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 98F-0825]


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 expand the safe use of 3,9-bis[2,4-bis(1-
methyl-1-phenylethyl)phenoxy]-2,4,8,10-tetraoxa-3,9-
diphosphaspiro[5.5]undecane, which may contain not more than 2 percent 
by weight of triisopropanolamine, as an antioxidant and/or stabilizer 
for polymers intended for use in contact with food. This action 
responds to a petition filed by Dover Chemical Corp.

DATES: This regulation is effective November 23, 1999. Submit written 
objections and requests for a hearing by December 23, 1999.
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: Andrew J. Zajac, Center for Food 
Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3095.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of October 6, 1998 (63 FR 53679), FDA announced that a food 
additive petition (FAP 8B4627) had been filed by Dover Chemical Corp., 
3676 Davis Rd. NW., Dover, OH 44622. The petition proposed to amend the 
food additive regulations in Sec. 178.2010 Antioxidants and/or 
stabilizer for polymers (21 CFR 178.2010) to expand the safe use of 
3,9-bis[2,4-bis(1-methyl-1-phenylethyl)phenoxy]-2,4,8,10-tetraoxa-3,9-
diphosphaspiro[5.5]undecane, which may contain not more than 2 percent 
by weight of triisopropanolamine, as an antioxidant and/or stabilizer 
for polymers intended for use in contact with food.
     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) the regulations in 
Sec. 178.2010 should be amended as set forth below.
     In accordance with Sec. 171.1(h) (21 CFR 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 by appointment with the 
information contact person listed above. As provided in Sec. 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 8B4627 (63 FR 
53679). 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 collections 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 
any time on or before December 23, 1999, file with the Dockets 
Management Branch (address above) written objections 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 description and 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 heading of this document. Any objections 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.

[[Page 65658]]

     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 178.2010 is amended in the table in paragraph (b) by 
revising the entry for ``3,9-bis[2,4-bis(1-methyl-1-
phenylethyl)phenoxy]-2,4,8,10-tetraoxa-3,9-
diphosphaspiro[5.5]undecane'' under the headings ``Substances'' and 
``Limitations'' to read as follows:


Sec. 178.2010   Antioxidants and/or stabilizers for polymers.

* * * * *
     (b) * * *

 
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             Substances                          Limitations
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*                    *                    *                    *
                   *                    *                    *
 3,9-Bis[2,4-bis(1-methyl-1-          For use only:
 phenylethyl)phenoxy]-2,4,8,10-       1. At levels not to exceed 0.15
 tetraoxa-3,9-                        percent by weight of all polymers,
 diphosphaspiro[5.5]undecane (CAS     except as specified below.
 Reg. No. 154862-43-8), which may     2. At levels not to exceed 0.2
 contain not more than 2 percent by   percent by weight of polycarbonate
 weight of triisopropanolamine (CAS   resins complying with Sec.
 Reg. No. 122-20-3).                  177.1580 of this chapter.
                                      3. At levels not to exceed 0.3
                                      percent by weight of
                                      polyetherimide resins complying
                                      with Sec.  177.1595 of this
                                      chapter.
 
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    Dated: October 28, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 99-30523 Filed 11-22-99; 8:45 am]
BILLING CODE 4160-01-F