[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
