[Federal Register Volume 63, Number 238 (Friday, December 11, 1998)]
[Rules and Regulations]
[Pages 68391-68393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32907]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 178
[Docket No. 98F-0291]
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 expanded safe use of sodium
2,2'-methylenebis(4,6-di-tert-butylphenyl)phosphate as a clarifying
agent in olefin polymers intended for use in contact with food. This
action is in response to a petition filed by Asahi Denka Kogyo K.K.
DATES: The regulation is effective December 11, 1998; written
objections and requests for a hearing by January 11, 1999.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
[[Page 68392]]
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 7, 1998 (63 FR 25212), FDA announced that a food
additive petition (FAP 8B4592) had been filed by Asahi Denka Kogyo
K.K., 5-2-13, Shirahata, Urawa City, Saitama 336, Japan. The petition
proposed to amend the food additive regulations in Sec. 178.3295
Clarifying agents for polymers (21 CFR 178.3295) to provide for the
expanded safe use of sodium 2,2'-methylenebis(4,6-di-tert-
butylphenyl)phosphate as a clarifying agent in olefin polymers intended
for use in contact with food (21 CFR 177.1520).
FDA has evaluated the data in the petition and other relevant
material. Based on this information, the agency concludes that the
proposed use of the additive is safe, that the additive will achieve
its intended technical effect, and therefore, that the regulations in
Sec. 178.3295 should be amended as set forth below.
FDA's review of this petition indicates that the additive may
contain trace amounts of formaldehyde as an impurity. The potential
carcinogenicity of formaldehyde was reviewed by the Cancer Assessment
Committee (the Committee) of FDA's Center for Food Safety and Applied
Nutrition. The Committee noted that for many years, formaldehyde has
been known to be a carcinogen by the inhalation route, but the
Committee concluded that these inhalation studies are not appropriate
for assessing the potential carcinogenicity of formaldehyde in food.
The Committee's conclusion was based on the fact that the route of
administration (inhalation) is not relevant to the safety of
formaldehyde residues in food and the fact that tumors were observed
only locally at the portal of entry (nasal turbinates). In addition,
the agency has received literature reports of two drinking water
studies on formaldehyde: (1) A preliminary report of a carcinogenicity
study purported to be positive by Soffritti et al. (1989), conducted in
Bologna, Italy (Ref. 1); and (2) a negative study by Til et al. (1989),
conducted in The Netherlands (Ref. 2). The Committee reviewed both
studies and concluded, concerning the Soffritti study, ``* * * that
data reported were unreliable and could not be used in the assessment
of the oral carcinogenicity of formaldehyde'' (Ref. 3). This conclusion
is based on a lack of critical detail in the study, questionable
histopathological conclusions, and the use of unusual nomenclature to
describe the tumors. Based on the Committee's evaluation, the agency
has determined that there is no basis to conclude that formaldehyde is
a carcinogen when ingested.
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 8B4592 (63 FR
25212). 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
any time on or before January 11, 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.
References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m and 4 p.m., Monday through Friday.
1. Soffritti, M., C. Maltoni, F. Maffei, and R. Biaggi,
``Formaldehyde: An Experimental Multipotential Carcinogen,''
Toxicology and Industrial Health, vol. 5, No. 5, pp. 699-730, 1989.
2. Til, H. P., R. A. Woutersen, V. J. Feron, V. H. M.
Hollanders, H. E. Falke, and J. J. Clary, ``Two-Year Drinking Water
Study of Formaldehyde in Rats,'' Food Chemical Toxicology, vol. 27,
No. 2, pp. 77-87, 1989.
3. Memorandum of Conference concerning ``Formaldehyde;'' Meeting
of the Cancer Assessment Committee, FDA, April 24, 1991, and March
4, 1993.
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, 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 178.3295 is amended in the table in the entry for
``Sodium 2,2'-methylenebis (4,6-di-tert-butylphenyl)phosphate'' by
revising entry ``2.'' under the heading ``Limitations'' to read as
follows:
Sec. 178.3295 Clarifying agents for polymers.
* * * * *
[[Page 68393]]
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Substances Limitations
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* * * *
* * *
Sodium 2,2'-methylenebis(4,6-di- For use only:
tert-butylphenyl)phosphate (CAS 1. * * *
Reg. No. 85209-91-2). 2. As a clarifying agent at levels
not exceeding 0.10 percent by
weight of polypropylene complying
with Sec. 177.1520(c) of this
chapter, items 1.1(a) or 1.1(b)
and of olefin polymers complying
with Sec. 177.1520(c) of this
chapter, items 3.1(a), 3.1(b),
3.1(c), 3.2(a), or 3.2(b) (where
the copolymers contain not less
than 85 weight percent of the
polymer units derived from
polypropylene.) The finished
polymers shall be used in contact
with foods only under conditions
of use A through H described in
Table 2 of Sec. 176.170(c) of
this chapter.
* * * *
* * *
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Dated: December 1, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-32907 Filed 12-10-98; 8:45 am]
BILLING CODE 4160-01-F
