[Federal Register Volume 64, Number 200 (Monday, October 18, 1999)]
[Rules and Regulations]
[Pages 56172-56173]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-26885]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 173
[Docket No. 98F-0749]
Secondary Direct Food Additives Permitted in Food for Human
Consumption; Ion Exchange Resins
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 safe use of the ion exchange
resin, methylacrylate-divinyl benzene diethylene glycol divinyl ether
terpolymer containing not less than 3.5 percent by weight of divinyl
benzene and not more than 0.6 percent by weight of diethylene glycol
divinyl ether, aminolyzed with dimethylaminopropylamine (DMAPA) to
treat water and aqueous foods without limits on the conditions of use,
and with a specification for DMAPA, an impurity in the ion exchange
resin. This action is in response to a petition filed by Rohm and Haas
Co.
DATES: This regulation is effective October 18, 1999; written
objections and requests for a hearing by November 17, 1999. The
Director of the Office of the Federal Register approves the
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51 of a certain publication in 173.25(b)(2) (21 CFR 173.25(b)(2)),
effective October 18, 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: James C. Wallwork, Center for Food
Safety and Applied Nutrition (HFS-215), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3078.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of September 15, 1998 (63 FR 49360), FDA announced that a food
additive petition (FAP 8A4609) had been filed by Rohm and Haas Co., 100
Independence Mall West, Philadelphia, PA 19106-2399. The petition
proposed to amend the food additive regulations in Sec. 173.25 Ion
exchange resins to provide for the safe use of the ion exchange resin,
methylacrylate-divinyl benzene diethylene glycol divinyl ether
terpolymer, identified in Sec. 173.25(a)(16), to treat water and
aqueous foods as described in Sec. 173.25(b)(2), without limits on the
conditions of use, and with a specification for DMAPA, an impurity in
the ion exchange resin.
The ion exchange resin is currently approved in Sec. 173.25(a)(16)
and (b)(2) as an ion exchange resin used to treat water and aqueous
food only of the types identified under categories I, II, and VI-B in
Table 1 of Sec. 176.170(c), provided that the temperature of the water
or food passing through the resin bed is maintained at 50 deg.C or
less and the flow rate of the water or food passing through the beds is
not less than 0.5 gallon per cubic foot per minute. Rohm and Haas Co.
has requested that the regulation in Sec. 173.25(b)(2) be amended to
provide for use of the ion exchange resin bed without the restrictions
on temperature and flow rate, but with establishment of a specification
of no more than 1 milligram (mg)/kilogram of DMAPA when extracted into
a food-simulating solvent and when measured by the method that is
incorporated by reference.
FDA estimates that the petitioned use of the ion exchange resin
will result in an estimated daily intake for DMAPA of 0.2 mg per person
per day (p/d) for the 90th percentile consumer, assuming that all foods
will be processed with this resin. This exposure is well below the
acceptable daily intake of 30 mg/p/d established by toxicology studies
submitted with the previous petitions for this resin.
FDA has evaluated data in the petition and other relevant material.
Based on this information, the agency concludes that the proposed use
of the ion exchange resin, methylacrylate-divinyl benzene diethylene
glycol divinyl ether terpolymer containing not less than 3.5 percent by
weight of divinyl benzene and not more than 0.6 percent by weight of
diethylene glycol divinyl ether, aminolyzed with DMAPA, to treat water
and aqueous foods without limits on the conditions of use, and with a
specification for DMAPA, an impurity in the ion exchange resin, is
safe, the ion exchange resin will achieve its intended effect, and
therefore, that 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 previously considered the environmental effects of
this rule as announced in the Notice of Filing for FAP 8A4609 (63 FR
49360). 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
[[Page 56173]]
environment and that an environmental impact statement is not 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
any time on or before November 17, 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, Incorporation by reference.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Director, Center for Food Safety and Applied
Nutrition, 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 adding paragraphs (b)(2)(i) and
(b)(2)(ii) to read as follows:
Sec. 173.25 Ion-exchange resins.
* * * * *
(b) * * *
(2) * * *
(i) The ion-exchange resin identified in paragraph (a)(13) of this
section is used to treat water and aqueous food only of the types
identified under categories I, II, and VI-B in Table 1 of
Sec. 176.170(c) of this chapter: Provided, That the temperature of the
water or food passing through the resin bed is maintained at 50 deg.C
or less and the flow rate of the water or food passing through the bed
is not less than 0.5 gallon per cubic foot per minute.
(ii) The ion-exchange resin identified in paragraph (a)(16) of this
section is used to treat water and aqueous food only of the types
identified under categories I, II, and VI-B in Table 1 of
Sec. 176.170(c) of this chapter, Provided, that either:
(A) The temperature of the water or food passing through the resin
bed is maintained at 50 deg.C or less and the flow rate of the water
or food passing through the bed is not less than 0.5 gallon per cubic
foot per minute; or
(B) Extracts of the resin will be found to contain no more than 1
milligram/kilogram dimethylaminopropylamine in each of the food
simulants, distilled water and 10 percent ethanol, when, following
washing and pretreatment of the resin in accordance with
Sec. 173.25(c)(1), the resin is subjected to the following test under
conditions simulating the actual temperature and flow rate of use:
``The Determination of 3-Dimethylaminopropylamine in Food Simulating
Extracts of Ion Exchange Resins,'' February 4, 1998, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies are available from the Division of Petition Control
(HFS-215), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, or may be examined
at the Center for Food Safety and Applied Nutrition's Library, 200 C
St. SW., rm. 3321, Washington, DC, or at the Office of the Federal
Register, 800 North Capitol St. NW., suite 700, Washington, DC.
* * * * *
Dated: September 28, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 99-26885 Filed 10-15-99; 8:45 am]
BILLING CODE 4160-01-F