[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
