[Federal Register Volume 62, Number 34 (Thursday, February 20, 1997)]
[Rules and Regulations]
[Pages 7678-7679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4082]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 96F-0184]


Secondary Direct Food Additives Permitted in Food for Human 
Consumption; Sulphopropyl Cellulose

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 a change in the level of reactants 
for sulphopropyl cellulose ion-exchange resin for the recovery and 
purification of proteins for food use. This action is in response to a 
petition filed by Life Technologies, Inc.

DATES: Effective February 19, 1997; written objections and requests for 
a hearing by March 21, 1997.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Andrew D. Laumbach, Center for Food 
Safety and Applied Nutrition (HFS-217), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3071.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of July 3, 1996 (61 FR 34852), FDA announced that a food 
additive petition (FAP 6A4500) had been filed by Life Technologies, 
Inc., 8400 Helgerman Ct., Gaithersburg MD 20874. The petition proposed 
to amend the food additive regulations in Sec. 173.25 (21 CFR 173.25) 
to provide for a change in the level of the reactants for sulphopropyl 
cellulose ion-exchange resin for the recovery and purification of 
proteins for food use. The amendment proposed that the amount of 
epichlorohydrin plus propylene oxide employed does not exceed 250 
percent by weight of the starting quantity of cellulose. The current 
regulation provides that the amount of epichlorohydrin plus propylene 
oxide employed does not exceed 61 percent by weight of the starting 
quantity of cellulose.
    In the Federal Register of April 22, 1991 (56 FR 16266), FDA 
published a final rule that amended the regulation under Sec. 173.25 to 
provide for the use of the ion-exchange resin and the starting 
materials used to manufacture the additive. The amendment to the 
regulation was based upon the information provided in FAP 6A3905. In 
the final rule of April 22, 1991, the agency stated that while the ion-
exchange resin has not been shown to cause cancer, it may contain small 
amounts of the starting materials epichlorohydrin (ECH) and propylene 
oxide (PO) as byproducts of its production. Because the chemicals ECH 
and PO have been shown to cause cancer in test animals, the agency 
conducted a quantitative risk assessment procedure to calculate the 
risk from the use of ECH and PO. Based on the results of the risk 
assessment, the agency concluded in the final rule of April 22, 1991, 
that there was a reasonable certainty of no harm from exposure to ECH 
and PO that might result from the proposed use of the additive.
    Recently, the agency was advised that the levels of the starting 
materials for the resin, ECH and PO, that are listed under 
Sec. 173.25(a)(20) need to be amended. The petitioner discovered that 
the information in FAP 6A3905 that was used to calculate the levels of 
ECH and PO in the listings for the regulation contained errors that led 
to an underestimation of the actual levels of ECH and PO used in the 
production of the resin. A new petition (FAP 6A4500) was submitted to 
correct the regulation by listing the actual ratios of the starting 
materials ECH and PO that are currently being used in the manufacture 
of the ion-exchange resin.
    The agency has reviewed the information in both petitions 6A3905 
and 6A4500, and it has determined that

[[Page 7679]]

the levels of ECH and PO set out in current Sec. 173.25(a)(20) are in 
error because those levels do not reflect the levels presently used by 
industry to manufacture the resin. The information in the present 
petition establishes that the manufacturing process and the resin 
composition do not differ from the process and resin composition 
evaluated in the original petition. Because the composition of the 
resin is unchanged, the exposure to the residues of ECH and PO remains 
unchanged. Therefore, the agency concludes that the agency's safety 
evaluation conducted for the original petition (FAP 6A3905) supports 
the safety of the amendment to Sec. 173.25 proposed by FAP 6A4500. 
Accordingly, the agency concludes that a recalculation of a risk 
assessment performed for the original petition (FAP 6A3905) is not 
necessary to support this action.
    Thus, 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 that therefore, (3) the regulations in 
Sec. 173.25 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 determined under 21 CFR 25.24(a)(9) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    Any person who will be adversely affected by this regulation may at 
any time on or before March 21, 1997, 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 173

     Food additives.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
173 is amended as follows:

PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR 
HUMAN CONSUMPTION

    1. The authority citation for 21 CFR part 173 continues to read as 
follows:

    Authority: Secs. 201, 402, 409 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 342, 348).

    2. Section 173.25 is amended by revising paragraph (a)(20) to read 
as follows:

Sec. 173.25  Ion-exchange resins.

* * * * *
    (a) * * *
    (20) Regenerated cellulose, cross-linked and alkylated with 
epichlorohydrin and propylene oxide, then sulfonated whereby the amount 
of epichlorohydrin plus propylene oxide employed does not exceed 250 
percent by weight of the starting quantity of cellulose.
* * * * *

    Dated: February 11, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-4082 Filed 2-19-97; 8:45 am]
BILLING CODE 4160-01-F