[Federal Register Volume 64, Number 156 (Friday, August 13, 1999)]
[Rules and Regulations]
[Pages 44121-44122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20889]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 96F-0415]


Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Petroleum Wax

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 
poly(alkylmethacrylate) as a processing aid in the manufacture of 
petroleum wax. This action is in response to a petition filed by Nalco/
Exxon Energy Chemicals.

DATES:  This regulation is effective August 13, 1999; written 
objections and requests for a hearing by September 13, 1999. The 
Director of the Office of the Federal Register approves the 
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51 of certain publications in Sec. 172.886(c)(2) (21 CFR 
172.886(c)(2)), effective August 13, 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:  Aydin Orstan, Center for Food Safety 
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3076.

SUPPLEMENTARY INFORMATION:  In a notice published in the Federal 
Register of November 14, 1996 (61 FR 58417), FDA announced that a food 
additive petition (FAP 7A4524) had been filed by Nalco/Exxon Energy 
Chemicals, L. P., c/o Keller and Heckman, 1001 G St. NW., suite 500 
West, Washington, DC 20001. The petition proposed to amend the food 
additive regulations in Sec. 172.886 Petroleum wax to provide for the 
safe use of poly(alkylmethacrylate) as a processing aid in the 
manufacture of petroleum wax.
    Based on the data in the petition and other relevant material, the 
agency has determined that: (1) Poly(alkylmethacrylate) closely 
resembles and functions as poly(alkylacrylate), which is currently 
listed in Sec. 172.886(c)(2) for use as a processing aid in the 
manufacture of petroleum wax; (2) poly(alkylmethacrylate) is a high 
molecular weight polymer whose absorption across the gastrointestinal 
membrane would be minimal; and (3) the estimated daily intake of the 
monomeric impurity alkylmethacrylates from the proposed use, 0.1 
milligram (mg)/person/day (d), is well below the acceptable daily 
intake of 30 mg/person/d established for alkylmethacrylates by the 
agency. Furthermore, the agency has determined that two methods 
incorporated by reference in Sec. 172.886(c)(2) for the analysis of 
poly(alkylacrylate) entitled ``Method for Determining Weight-Average 
and Number-Average Molecular Weight and for Determining Alkylacrylate 
Monomer Content of Poly(alkylacrylate) used as Processing Aid in 
Manufacture of Petroleum Wax'' and ``Method for Determining Residual 
Level of Poly(alkylacrylate) in Petroleum Wax,'' are applicable to the 
analysis of poly(alkylmethacrylate). Based on this information, FDA 
concludes that the proposed food use of poly(alkylmethacrylate) as a 
processing aid in the manufacture of petroleum wax is safe, the 
additive will achieve its intended technical effect, and therefore, 21 
CFR part 172 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 carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.
    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 September 13, 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

[[Page 44122]]

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 172

    Food additives, Incorporation by reference, Reporting and 
recordkeeping requirements.
    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 172 is amended as follows:

PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION

     1. The authority citation for 21 CFR part 172 continues to read as 
follows:

     Authority:  21 U.S.C. 321, 341, 342, 348, 371, 379e.

     2. Section 172.886 is amended by revising paragraph (c)(2) to read 
as follows:


Sec. 172.886   Petroleum wax.

* * * * *
    (c) * * *
    (2) Poly(alkylacrylate) (CAS Reg. No. 27029-57-8), made from long 
chain (C16-C22) alcohols and acrylic acid, or 
poly(alkylmethacrylate) (CAS Reg. No. 179529-36-3), made from long 
chain (C18-C22) methacrylate esters, having:
     (i) A number average molecular weight between 40,000 and 100,000;
    (ii) A weight average molecular weight (MWw) to number 
average molecular weight (MWn) ratio (MWw/
MWn) of not less than 3; and
    (iii) Unreacted alkylacrylate or alkylmethacrylate monomer content 
not in excess of 14 percent, as determined by a method entitled 
``Method for Determining Weight-Average and Number-Average Molecular 
Weight and for Determining Alkylacrylate Monomer Content of 
Poly(alkylacrylate) used as Processing Aid in Manufacture of Petroleum 
Wax,'' which is incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. Copies are available from the Office of 
Premarket Approval (HFS-200), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC 
20204, or may be examined at the Center for Food Safety and Applied 
Nutrition's Library, Food and Drug Administration, 200 C St. SW., 
Washington, DC, or at the Office of the Federal Register, 800 North 
Capitol St. NW., suite 700, Washington, DC. Petroleum wax shall contain 
not more than 1,050 parts per million of poly(alkylacrylate) or 
poly(alkylmethacrylate) residues as determined by a method entitled 
``Method for Determining Residual Level of Poly(alkylacrylate) in 
Petroleum Wax,'' which is incorporated by reference. Copies are 
available from the addresses cited in this paragraph.
 * * * * *

    Dated: August 5, 1999.
Janice F. Oliver,
Deputy Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 99-20889 Filed 8-12-99; 8:45 am]
BILLING CODE 4160-01-F