[Federal Register Volume 65, Number 230 (Wednesday, November 29, 2000)]
[Rules and Regulations]
[Pages 71056-71058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-30453]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket No. 99F-1912]


Irradiation in the Production, Processing, and Handling of Food

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 ultraviolet (UV) 
irradiation to reduce human pathogens and other microorganisms in juice 
products. This action is in response to a food additive petition filed 
by California Day-Fresh Foods, Inc.

DATES: This rule is effective November 29, 2000. Submit written 
objections and requests for a hearing by December 29, 2000.

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:  William J. Trotter, Center for Food 
Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3088.

SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register of June 25, 1999 (64 
FR 34258), FDA announced that a food additive petition (FAP 9M4676) had 
been filed by California Day-Fresh Foods, Inc., 533 West Foothill 
Blvd., Glendora, CA 91741. The petitioner proposed that the food 
additive regulations in part 179 Irradiation in the Production, 
Processing and Handling of Food (21 CFR part 179) be amended to provide 
for the safe use of UV light to reduce human pathogens and other 
microorganisms in juice products.

II. Safety Evaluation

    Under section 201(s) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 321(s)), a source of radiation used to treat food 
is defined as a food additive. The additive is not, literally, added to 
food. Instead, a source of radiation is used to process or treat food 
such that, analogous to other food processes, its use can affect the 
characteristics of the food. In the subject petition, the intended 
technical effect is a change in the microbial load of the food, 
specifically, a reduction of human pathogens and other microorganisms 
in juice products.

A. Toxicology

    FDA has evaluated the safety of the use of UV irradiation to reduce 
human pathogens and other microorganisms in juices. This safety 
assessment was based on the current understanding of the effects of UV 
irradiation on the major chemical components of food. Having evaluated 
the data in the petition and other relevant material in the agency's 
files, the agency finds that any photochemical changes that may occur 
as a result of the UV irradiation are of no toxicological significance 
(Ref. 1).

B. Microbiology

    The petitioner submitted data demonstrating the reduction of 
specific pathogens (Escherichia coli O157:H7, Listeria monocytogenes, 
and Salmonella) inoculated into four types of juices (orange, apple, 
carrot, and garden vegetable). These four juice varieties are 
representative of the types of juice that are consumed by the U.S. 
population and that could be treated with UV irradiation (Ref. 2). 
After UV irradiation, there were significant reductions in pathogens. 
FDA concludes that the proposed use is effective in reducing human 
pathogens in juices and that treated juices will be at least as safe as 
untreated juices currently on the market (Ref. 3). However, the 
submitted microbiological data do not constitute the type of validation 
studies necessary to demonstrate the achievement of specific 
performance standards, e.g. 5-log reductions, for human pathogen 
control programs (Ref. 3). Therefore, users of this UV treatment who 
are subject to certain performance standards will need to establish 
that this treatment meets their required level of human pathogen 
reduction.

C. Specifications for Use

    The petitioned UV radiation is produced by low pressure mercury 
lamps, which emit more than 90 percent of their light at 253.7 
nanometers (nm) (2,537 Angstroms); juice being treated passes through a 
transparent tube in which the juice is subjected to UV irradiation. 
Because most juices strongly absorb UV radiation, most of the UV 
radiation would be absorbed by the juice at the wall of the tube near 
the source of the UV irradiation. However, the amount of UV irradiation 
that would reach juice in the middle of the tube would be insufficient 
to reduce significantly human pathogens. Therefore, the petitioner 
proposed that the juices flow under turbulent conditions that produce 
eddies and swirls in the juice to ensure that as much juice as possible 
will reach the wall of the UV transparent tube where the juice would be 
exposed to UV irradiation. This would help to reduce human pathogens 
and other microorganisms throughout the juice. The conditions for 
turbulent flow are described mathematically by the unitless Reynolds 
number (Re):
[GRAPHIC] [TIFF OMITTED] TR29NO00.001

where:

D is the tube diameter,
u is fluid velocity,
p is fluid density, and
<greek-m> is fluid viscosity.

To ensure that sufficient turbulent flow is achieved, the petitioner 
has requested that a limit of a Reynolds number of no less than 2,200 
be incorporated into the regulation. FDA concurs with this 
specification (Ref. 4).
    The amount of UV irradiation necessary for human pathogen reduction 
will depend on various factors, such as the type of juice, the initial 
microbial load, and the design of the irradiation system (e.g., flow 
rate, number of lamps, and time exposed to irradiation). Therefore, FDA 
is not specifying a minimum or maximum dose by regulation, but 
concludes that this should be achieved for individual usage situations 
in a manner consistent with good manufacturing practice (Ref. 5). FDA 
expects that the maximum dose applied to the juice will be economically 
self-limiting due to the costs associated with UV irradiation. 
Additionally, the levels of UV irradiation applied to the juice will be 
limited by the possible alterations in organoleptic characteristics of 
the juice (i.e., changes in taste or color) after UV irradiation, 
changes that may result in decreased consumer acceptance. Thus,

[[Page 71057]]

juice processors will also limit the maximum applied dose of UV 
irradiation to avoid production of a product not acceptable to 
consumers (Ref. 5).
    Based on the data and studies submitted in the petition and other 
information in the agency's files, FDA concludes that the proposed use 
of UV irradiation of juice products is safe, that the irradiation will 
achieve its intended technical effect, and therefore, that the 
regulations in Sec. 179.39 should be amended as set forth below.

D. Other Changes to Sec. 179.39

    FDA is also making an editorial change to the existing regulation 
to describe more accurately the approved emission sources and to remove 
an unnecessary and confusing description. This change does not affect 
the nature or properties of permitted sources. Currently, 
Sec. 179.39(a) stipulates that ``The radiation sources consist of 
ultraviolet emission tubes designed to emit wavelengths within the 
range of 2200-3000 Angstrom units with 90 percent of the emission being 
the wavelength 2537 Angstrom units.'' The stipulation that 90 percent 
of the emission is at 253.7 nm (2,537 Angstroms) is sufficient to 
describe the sources as low pressure mercury lamps. Furthermore, since 
a small percentage of the emission from these tubes is outside of the 
220.0 to 300.0 nm (2,200 to 3,000 Angstroms) range, this restriction is 
factually inaccurate. Therefore, FDA is removing the restriction of the 
wavelength range in Sec. 179.39(a) and in the table in paragraph (b) 
under the ``Limitations column,'' and is instead specifying that the 
source of the irradiation to be low pressure mercury lamps.

III. Public Disclosure

    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.

IV. Environmental Impact

    The agency has previously considered the environmental effects of 
this rule as announced in the Filing Notice for FAP 9M4676 (June 25, 
1999, 64 FR 34258). 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 environment and that an environmental 
impact statement is not required.

V. Paperwork Reduction Act of 1995

    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.

VI. Objections

    Any person who will be adversely affected by this regulation may at 
any time file with the Dockets Management Branch (address above) 
written objections by December 29, 2000. 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 are to be 
submitted and are to 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.

VII. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.

    1. FDA Memorandum, A. Mattia to W. Trotter, November 2, 1999.
    2. FDA Memorandum, E. Jensen to W. Trotter, September 6, 2000.
    3. FDA Memorandum, R. Merker to W. Trotter, January 26, 2000.
    4. FDA Memorandum, E. Jensen to W. Trotter, October 27, 1999.
    5. FDA Memorandum, E. Jensen to W. Trotter, October 27, 2000.

List of Subjects in 21 CFR Part 179

    Food additives, Food labeling, Food packaging, Radiation 
protection, Reporting and recordkeeping requirements, Signs and 
symbols.


    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 179 is amended as follows:

PART 179--IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF 
FOOD

    1. The authority citation for 21 CFR part 179 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 343, 348, 373, 374.

    2. Section 179.39 is amended by revising paragraph (a) and by 
revising the table in paragraph (b) to read as follows:


Sec. 179.39  Ultraviolet radiation for the processing and treatment of 
food.

* * * * *
    (a) The radiation sources consist of low pressure mercury lamps 
emitting 90 percent of the emission at a wavelength of 253.7 nanometers 
(2,537 Angstroms).
    (b) * * *

 
------------------------------------------------------------------------
    Irradiated food            Limitations                  Use
------------------------------------------------------------------------
Food and food products   Without ozone            Surface microorganism
                          production: high fat-    control.
                          content food
                          irradiated in vacuum
                          or in an inert
                          atmosphere; intensity
                          of radiation, 1 W (of
                          2,537 A. radiation)
                          per 5 to 10 ft.<SUP>2</SUP>

[[Page 71058]]

 
Potable water            Without ozone            Sterilization of water
                          production;              used in food
                          coefficient of           production.
                          absorption, 0.19 per
                          cm or less; flow rate,
                          100 gal/h per watt of
                          2,537 A. radiation;
                          water depth, 1 cm or
                          less; lamp-operating
                          temperature, 36 to 46
                          deg.C.
Juice products           Turbulent flow through   Reduction of human
                          tubes with a minimum     pathogens and other
                          Reynolds number of       microorganisms.
                          2,200.
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    Dated: November 14, 2000.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 00-30453 Filed 11-28-00; 8:45 am]
BILLING CODE 4160-01-F