[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
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) * * *
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Irradiated food Limitations Use
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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.2
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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