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CASCADIAN®
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O3
Water Systems, Inc.
17700 147th St SE
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USA
Phone:
360-794-9511
Fax: 360-794-0856
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This Article Was Reprinted from Volume 29, No. 1 of Ozone News
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Milestone Event - Ozone for
Food Processing
EPRI Files Food Additive Petition for Ozone as An Antimicrobial Agent
Rip
G. Rice 1 and Dee M. Grahain2
1
President, RICE International Consulting Enterprises. Associate Editor, Ozone
News
1331 Patuxent Drive, Ashton, MD (USA) 20861
RipRice_Ozonet@compuserve.com; rrice@IUVA.org
2
President, R&D Enterprises. 2747 Hutchinson Court, Walnut Creek, CA (USA)
94598
Deeg2 1 3050@aol.com; dgraham@epri.com
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On
August 2, 2000 a milestone event for ozone occurred when a food additive
petition (FAP) was filed by the Electric Power Research Institute (the EPRI)
with the U.S. Food and Drug Administration (the FDA) to allow the use of ozone
as an antimicrobial agent for direct contact with foods. The FAP was accepted
for expedited review by the FDA and action is expected in 60 to 90 days.
Background
Prior
to mid-1997, there were few or no commercial applications of ozone in food
processing or treatment in the United States. The reason was entirely regulatory
in nature, and had nothing at all to do with the technology of ozone. The
regulatory blockage to the use of ozone is the Federal Food, Drug and Cosmetic
Act, passed in the late 1950s and under which the Food and Drug Administration
is required to operate. The Act defines any material that comes in contact with
food to be a “food additive”, which must be approved by the FDA prior to use.
Regulatory
Impediments to the Use of Ozone
Food Additive Petitions
A
Food Additive Petition (FAP) is required for approval of a candidate material as
a food additive. A major problem with filing a FAP for ozone is that the
petitioner must present a range of data showing the minimum amount of exposure
to ozone below which ozone is ineffective for its intended purpose, and also
data to show the maximum amount of exposure to ozone above which ozone will
damage the food item. For a long time, the FDA also required petitioners for
ozone approval to present data showing that byproducts formed during ozonation
will not be toxic to consumers. Since ozone was not approved by the FDA for food
contact, the reciprocal statement became tine - the application of ozone in
direct contact with foods is illegal in the USA.
For
the small food processor wanting to use ozone to lower microorganism counts on
the surfaces of foods to reduce the risks from potential pathogens and to extend
the product shelf life, these FDA requirements discouraged the commercialization
of ozone for food processing. Approval requires many months, often years, of
testing and data gathering for each application - a costly undertaking to say
the least. In point of fact, even today, the FDA has not approved any food
additive petition involving ozone. On the other hand, the long-anticipated
regulatory breakthrough may finally be at hand.
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Gras Affirmations
Prior
to early 1997, the FDA accepted petitions to affirm the GRAS (Generally
Recognized As Safe) status of various materials used in food processing. GRAS
status could be based on a long history of safe commercial use of such materials
prior to passage of the Food, Drug and Cosmetic Act (in the late 1950s). A
second procedure to obtain GRAS status was for a panel of recognized (by the
FDA) food experts to determine, based on published scientific studies as well as
their own direct knowledge and experience in the field of food safety. that the
use of a certain material in contact food processing under Good Manufacturing
Practices is Generally Recognized As Safe (GRAS). In early 1997. FDA declared
that it would no longer accept GRAS petitions; - however, the Expert Panel GRAS
affirmation route still is available (FDA, 1997).
Gras Affirmation of Ozone
for Bottled Water Treatment
In
the early 1980s, the International Bottled Water Association petitioned the FDA
to affirm that the application of ozone to disinfect bottled water under
specified conditions is GRAS. The conditions included a maximum dosage of ozone of 0.4 mg/L over 4 minutes contact
time, and that the water to be treated must meet the potable water requirements
of the U.S. Environmental Protecting Agency. The FDA approved the application
for bottled water, and in 1982 published in the Code of Federal Regulations a formal FDA regulation affirming GRAS
Status for use of ozone (FDA, 1982). Later, the FDA also approved the use of
ozone as a sanitizing agent for
bottled water treatment lines, under a similar GRAS petition.
At the present time, these two bottled water applications
are the only FDA approved food applications for ozone.
Unfortunately,
the GRAS approval for ozone disinfection of bottled water in 1982 contained the
statement [21 C.F.R. l84.l(b)(2)] “All other food additive applications for
ozone must be the subject of appropriate Food Additive Petitions.” This
statement effectively mandates the filing of Food Additive Petitions in order to
gain FDA approval for the use of ozone in direct contact with foods.
The 1997 EPRI GRAS
Declaration
In
June 1997, an Expert Panel of Food Scientists convened by the EPRI (EPRI, 1997)
concluded the following:
“The
available information supports the safety of ozone when used as a food
disinfectant or sanitizer, and further, that the available information supports
a GRAS classification of ozone as a disinfectant or sanitizer for foods when
used at levels and by methods of application consistent with good
manufacturing practices (authors’ underscoring for emphasis).”
Naturally,
the FDA had been advised of the creation of the EPRI-sponsored panel of food
experts, their technical qualifications, and the intent of this group.
Additionally, a copy of the FPRJ-sponsored Expert Panel Report was provided to
the FDA for their information. By FDA’s own internal policies, the agency has
90-days after receipt of such a document to disagree or to otherwise indicate
that it has problems with the GRAS declaration
No such disagreement with the EPRI GRAS declaration has been received
since it was
published in June 199
(Graham,
1997)
In
April, 1997, FDA published a notice in which the agency proposed that any
organization willing to affirm a substance as GRAS when coming into contact with
foods is free to utilize that substance, provided the organization is willing to
accept responsibility for its actions (FDA, 1997). In other words, since
affirming a substance to be GRAS does not imply formal regulatory approval by
the FDA, it is up to the affirming organization, or any organization intending
to apply ozone in contact with foods, to understand what ozone is all about, how
it is generated and applied, in what exposure levels, and what the consequences
of its use are in terms of providing specific benefits. Included in this caution
is knowing what disadvantages might accrue from the over-application of ozone to
the particular food(s) being treated.
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Post-1997
Regulatory Developments with Ozone in the USA
EPRI’s
GRAS affirmation gives a clear green light to food processors to test and use
ozone for a variety of food processing applications. Also, the lack of a
negative response from FDA to the EPRI GRAS declaration supports the EPRI Expert
Panel conclusions. And although FDA’s published proposal not to contest food
applications for substances that have been affirmed to be GRAS by a duly
constituted panel of experts, nevertheless the lack of specific regulatory
approval for ozone published in the Federal Register continues to disturb many
food processors and still slows the broader acceptance of ozone in the food
industry.
FDA
recognizes this, and also recognizes that most applications for ozone in food
treatment involve antimicrobial properties of ozone. However, the statement in
the 1982 GRAS approval for ozone in bottled water disinfection which says,
“All other food applications for ozone must be the subject of appropriate food
additive petition(s)’, continues to impede the development of ozone for food
processing applications.
Consequently,
in mid-1999, the FDA suggested to the EPRI that a single FAP which provides FDA
with specific data showing the antimicrobial properties of ozone in a number of
food processing applications could be reviewed quickly, and if approved, would
overcome the requirement of the 1982 GRAS regulation regarding “other food
uses for ozone”. EPRI has agreed with this FAP approach and, with considerable
support from several interested food processing organizations, has developed
such a FAP and formally filed it with the FDA in August 2000 (EPRI, 2000).
Responsive action on this FAP from the FDA is expected beginning in 2001.
Formal
regulatory approval by the FDA for the use of ozone as an Antimicrobial Agent in
direct contact with foods will clear away the regulatory hurdle that has impeded
application of ozone to foods in the United States, and will reassure
food-processing firms wishing to improve the qualities of their products by
approaches involving ozone.
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The
EPRI Ozone Antimicrobial Food Additive Petition
This
FAP is rather large (> 400 pages plus cited references), and involves a
review of as much published information on the subject of antimicrobial effects
of ozone on as many specific types of foods as these authors could assemble
within the time frame involved. Many organizations in the food industry have
assisted in this effort, and their help is acknowledged with gratitude.
The
basic outline of the FAP is as follows:
Title:
Ozone as an Antimicrobial Agent for the
Treatment,
Storage and Processing of Foods in Gaseous and Aqueous Phases
Outline:
Identity/Technical
Properties of Ozone
Amounts of Ozone, Purpose(s),
Directions and Labeling
Supportive Data for Specific Ozone
Applications
Specific Applications for Ozone
Analytical Methods for Ozone
Safety of Ozone
Tolerance Conditions and Proposed
Regulation
Modification
of Existing Regulation
Environmental Assessment
Each
of these sections is required by the FDA for any FAP.
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Copies
of the FAP are only available through the FDA’s Freedom of Information Office
in Washington, DC. Once the FAP has been approved by the FDA, then EPRL is
expected to make copies of the FAP itself available for a fee, but not copies of
the literature references. This is because FDA might request some additional
information to be submitted or for some modifications to be made prior to final
approval.
In
a paper presented at the IOA’s PAG Orlando meeting and again at the IOA’s
EA3G Berlin meeting (both in October 2000), the authors of the FAP presented a
detailed discussion of the subject matter and included the following Summary And Recommendations:
“It
is abundantly clear that ozone is a remarkably effective microbiocidal agent.
However, it is also a very powerful and effective oxidizing agent as well. The
trick to the propitious use of ozone in treating food products is to apply
sufficient ozone to accomplish its intended purpose(s), but to ensure that not
enough ozone is applied to damage the food by oxidation. For example, ozone
treatment of carrots resulted in somewhat lighter colors (Liew; and Prange,
1994).
Therefore,
anyone wishing to apply ozone to control microorganisms on a particular food,
whether the ozone is employed in the aqueous or gas phases, is advised to
conduct sufficient testing to determine the following:
1.
The minimum ozone exposure to
accomplish the intended purpose(s)
2.
The maximum ozone exposure above which the food is damaged oxidatively
3.
The conditions of ozone application
so as to protect plant workers from being exposed to ozone
4.
The costs of ozone application under these “good manufacturing
practices”.
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References
EPRI,
1997, Technical Report-108026, Vols. 1, 2, 3 Expert Panel Report: “Evaluation
of the History and Safety of Ozone in Processing Food for Human Consumption”
(EPRI, 3412 Hillview Ave., Palo Alto, CA 94304)
EPRI,
2000, “Ozone as an Antimicrobial Agent for the Treatment, Storage and
Processing of Foods in Gas and Aqueous
Phases”, Food Additive Petition filed with FDA, August 2, 2000 (EPRI, 3412
Hillview Ave., Palo Alto, CA 94304).
FDA,
1982, “GRAS Status of Ozone”, Federal Register 47(21 5):50209-502 10.
FDA,
1997, “Substances Generally Recognized As Safe; Proposed Rule”, Federal
Register 62(74): 18937-18964.
C.
L. Liew; R.K. Prange, 1994, “Effect of ozone and storage temperature on
post-harvest diseases and physiology of carrots (Daucus carota L.)”, J. Amer.
Hort. Sci. 1 l9(3):563-567.
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