[Federal Register Volume 64, Number 58 (Friday, March 26, 1999)]
[Rules and Regulations]
[Pages 14608-14610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-7515]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 173
[Docket No. 96F-0248]
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 limitations 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: The regulation is effective March 26, 1999; written objections
and requests for a hearing by April 26, 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: Andrew D. Laumbach, Center for Food
Safety and Applied Nutrition (HFS-215), 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 22, 1996 (61 FR 37905), FDA announced that a food
additive petition (FAP 6A4502) had been filed by Life Technologies,
Inc., 8400 Helgerman Ct., Gaithersburg, MD 20874 (now, 9800 Medical
Center Dr., Rockville, MD 20850). The petition proposed to amend the
food additive regulations in Sec. 173.25(b)(5) Ion-exchange resins (21
CFR 173.25(b)(5)) to provide for a change in the temperature and pH
limitations for sulphopropyl cellulose
[[Page 14609]]
ion-exchange resin for the recovery and purification of proteins for
food use.
In the notice of filing, published in the Federal Register on July
22, 1996, the agency announced that it was placing the environmental
assessment (EA) on display at the Dockets Management Branch for public
review and comment. No comments were received. On July 29, 1997, FDA
published revised regulations under part 25 (21 CFR part 25), which
became effective on August 28, 1997. These regulations established
additional categorical exclusions for a number of FDA actions. As a
result, such actions would no longer require the submission of an EA.
Because the agency had not completed its review of the EA submitted
with the petition, the agency evaluated whether a categorical exclusion
under revised Sec. 25.32(j) would apply to this rule.
After the filing of the petition on July 22, 1996, FDA determined
that the petitioned amendment of the food additive regulations in
Sec. 173.25(b)(5) also necessitated an amendment of the provisions in
Sec. 173.25(d)(2), that provide extraction requirements for the ion-
exchange resin. FDA published an amended filing notice in the Federal
Register of August 28, 1998 (63 FR 46053), to announce this change. The
amended filing notice also contained the agency's determination that
the proposed action would not have a significant impact on the human
environment, and therefore, that neither an environmental assessment
nor an environmental impact statement was required. The notice,
however, incorrectly cited the categorical exclusion under
Sec. 25.32(i), rather than the exclusion under Sec. 25.32(j).
FDA published a final rule in the Federal Register of April 22,
1991 (56 FR 16266), that amended the regulation under Sec. 173.25 to
provide for the use of the ion-exchange resin and starting materials
used to manufacture the sulphopropyl cellulose ion-exchange resin. The
amendment to the regulation was based upon information provided in FAP
6A3905. In the final rule of April 22, 1991, the agency stated that
while the sulphopropyl cellulose 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 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 (upper-bound limit
of individual lifetime risk no greater than 8x10-15) and PO
(upper-bound limit of individual lifetime risk no greater than
1x10-14) that might result from the proposed use of the
additive.
As stated previously, FAP 6A4502 was submitted to amend the
regulations in Sec. 173.25(b)(5) and (d)(2) by changing the limitations
for the temperature, pH, and the extraction requirements for the
sulphopropyl cellulose ion-exchange resin. The petitioner did not
propose any changes to the provisions under Sec. 173.25(a)(20) for the
manufacturing process, involving the starting materials ECH and PO, for
the ion-exchange resin.
The agency has reviewed the information in the FAP's 6A3905 and
6A4502, and has determined that the information in FAP 6A4502 does not
indicate a change in the manufacturing process. Therefore, the resin
composition in FAP 6A4502 does not differ from the resin composition
evaluated in the original petition (FAP 6A3905). Moreover, based on its
evaluation, the agency finds that the proposed changes to the
limitations for the temperature, pH, and the extraction requirements
for the ion-exchange resin are expected to reduce the potential level
of exposure to the residues of ECH and PO. 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.
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, 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 Sec. 25.32(j) 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.
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
anytime on or before April 26, 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.
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: 21 U.S.C. 321, 342, 348.
2. Section 173.25 is amended by revising paragraphs (b)(5) and
(d)(2) to read as follows:
Sec. 173.25 Ion-exchange resins.
* * * * *
(b) * * *
(5) The ion-exchange resin identified in paragraph (a)(20) of this
section is limited to use in aqueous process
[[Page 14610]]
streams for the isolation and purification of protein concentrates and
isolates under the following conditions:
(i) For resins that comply with the requirements in paragraph
(d)(2)(i) of this section, the pH range for the resin shall be no less
than 3.5 and no more than 9, and the temperatures of water and food
passing through the resin bed shall not exceed 25 deg.C.
(ii) For resins that comply with the requirements in paragraph
(d)(2)(ii) of this section, the pH range for the resin shall be no less
than 2 and no more than 10, and the temperatures of water and food
passing through the resin shall not exceed 50 deg.C.
* * * * *
(d) * * *
(2) The ion-exchange resin identified in paragraph (a)(20) of this
section shall comply either with:
(i) The extraction requirement in paragraph (c)(4) of this section
by using dilute sulfuric acid, pH 3.5 as a substitute for acetic acid;
or
(ii) The extraction requirement in paragraph (c)(4) of this section
by using reagent grade hydrochloric acid, diluted to pH 2, as a
substitute for acetic acid. The resin shall be found to result in no
more than 25 parts per million of organic extractives obtained with
each of the following solvents: Distilled water; 15 percent alcohol;
and hydrochloric acid, pH 2. Blanks should be run for each of the
solvents, and corrections should be made by subtracting the total
extractives obtained with the blank from the total extractives obtained
in the resin test.
* * * * *
Dated: March 17, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-7515 Filed 3-25-99; 8:45 am]
BILLING CODE 4160-01-F
