[Federal Register: April 3, 2002 (Volume 67, Number 64)]
[Rules and Regulations]               
[Page 15719-15720]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03ap02-5]                         
 
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
Food and Drug Administration
 
21 CFR Part 173
 
[Docket No. 01F-0233]
 
 
Secondary Direct Food Additives Permitted in Food for Human 
Consumption
 
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 acidified sodium 
chlorite solutions as an antimicrobial agent in water applied to 
processed fruits and vegetables. This action is in response to a 
petition filed by Alcide Corp.
 
DATES: This rule is effective April 3, 2002. Submit written objections 
and requests for a hearing by May 3, 2002.
 
ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/
dockets/ecomments.
 
FOR FURTHER INFORMATION CONTACT: Robert L. Martin, Center for Food 
Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 202-418-3074.
 
SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of May 23, 2001 (66 FR 28525), FDA announced that a food 
additive petition (FAP 1A4729) had been filed by Alcide Corp., 8561 
154th Ave., NE., Redmond, WA 98052. The petition proposed to amend the 
food additive regulations in Sec. 173.325 Acidified sodium chlorite 
solution (21 CFR 173.325) to provide for the safe use of aqueous 
solutions of acidified sodium chlorite as an antimicrobial agent in 
processing waters applied to processed fruits and vegetables.
    FDA is using the term ``processed'' consistent with the meaning of 
that term set forth in FDA's Antimicrobial Food Additives--Guidance (64 
FR 40612, July 27, 1999) (the 1999 guidance). The 1999 guidance 
describes FDA's interpretation of its jurisdiction over antimicrobial 
substances subsequent to the enactment of the Food Quality Protection 
Act of 1996 and the Antimicrobial Regulation Technical Corrections Act 
of 1998. The 1999 guidance is consistent with the Environmental 
Protection Agency's
 
[[Page 15720]]
 
(EPA's) and FDA's joint legal and policy interpretation of ``processed 
food'' (63 FR 54532, October 9, 1998). According to the 1999 guidance, 
processed fruits and vegetables include those that are ground, chopped, 
sliced, cut or peeled, and do not include fruits and vegetables that 
simply have leaves, stems, or husks removed. This food additive use of 
acidified sodium chlorite is for use in water to which processed fruits 
and vegetables are added (e.g., to which fruits and vegetables that 
have been ground, chopped, sliced, cut, or peeled are added) in order 
to mitigate microbiological organisms on the processed fruits and 
vegetables.
    Also, as discussed in the 1999 guidance, antimicrobial substances 
used to mitigate microbiological organisms on processed food, by adding 
such substances to water to which processed food is added, are subject 
to regulation as food additives. The petitioned use of acidified sodium 
chlorite as an antimicrobial agent in ``processing waters'' is intended 
to mitigate microbiological organisms only on the processed fruits and 
vegetables that are added to the water. Thus, the petitioned use is 
subject to regulation by FDA as a food additive. To the extent that a 
manufacturer wants to use acidified sodium chlorite in water to 
mitigate microbiological organisms in the water itself or to include 
mitigation of microbiological organisms in the water in addition to 
those on the processed fruits and vegetables that are added to the 
water, the manufacturer would need to petition FDA for that food 
additive use, which is outside the scope of this rule. In addition, the 
manufacturer would need to consult with EPA to determine whether a 
pesticide registration would be required for such use.
    FDA is requiring, as part of this regulation, that the use of the 
additive be followed by a potable water rinse and a 24-hour holding 
period to ensure that there are no detectable residue levels from the 
use of the additive on the treated processed fruits and vegetables.
    FDA has evaluated the data in the petition and other relevant 
material. Based on this information, the agency concludes that the 
proposed use of the additive is safe, that the additive will achieve 
its intended technical effect, and therefore, that the regulation in 
Sec. 173.325 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.
    In the notice of filing, FDA gave interested parties an opportunity 
to submit comments on the petitioner's environmental assessment. FDA 
received no comments in response to that notice.
    The agency has considered carefully the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.
    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 affected adversely by this regulation may 
file with the Dockets Management Branch (address above) written 
objections by May 3, 2002. Each objection shall be numbered separately, 
and each numbered objection shall specify with particularity the 
provisions of the regulation to which the objection is made and the 
grounds for the objection. Each numbered objection for 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 are to be submitted and are to be 
identified with the docket number found in the brackets in the heading 
of this document. Any objections received in response to the regulation 
may be seen in the Dockets Management Branch (address above) 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 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 173.325 is amended by redesignating paragraph (g) as 
paragraph (h) and by adding a new paragraph (g) to read as follows:
 
 
Sec. 173.325  Acidified sodium chlorite solutions.
 
* * * * *
    (g) The additive is used as an antimicrobial agent in the water 
applied to processed fruits and processed root, tuber, bulb, legume, 
fruiting (i.e., eggplant, groundcherry, pepino, pepper, tomatillo, and 
tomato), and cucurbit vegetables in accordance with current industry 
standards of good manufacturing practices, as a component of a spray or 
dip solution, provided that such application be followed by a potable 
water rinse and a 24-hour holding period prior to consumption. However, 
for processed leafy vegetables (i.e., vegetables other than root, 
tuber, bulb, legume, fruiting, and cucurbit vegetables) and vegetables 
in the Brassica [Cole] family, application must be by dip treatment 
only, and must be preceded by a potable water rinse and followed by a 
potable water rinse and a 24-hour holding period prior to consumption. 
When used in a spray or dip solution, the additive is used at levels 
that result in sodium chlorite concentrations between 500 and 1,200 
ppm, in combination with any GRAS acid at a level sufficient to achieve 
a solution pH of 2.3 to 2.9.
* * * * *
 
    Dated: February 28, 2002.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 02-7969 Filed 4-2-02; 8:45 am]
BILLING CODE 4160-01-S