[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