[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.

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[[Page 68393]]



 
------------------------------------------------------------------------
             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