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CHEMICAL MANUFACTURERSASSOCIATION
COURTNEY
M.
PRICE
June 29,1998
VICEPRESIDENT
CHEMSTAR
Food and Drug Administration
()
135
Dockets Management Branch (HFAS-30$)- 12420 Parklawn Drive
Room 1-23
Rockville, MD 20857
RE:
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Comments on B aft Guide to Minimize Microbial Food Safetv Hazards
for Fresh Fruits and Vegetables - Docket # 97N-0451
Dear Sir or Madam:
The Chlorine Dioxide Panel (Panel) of the Chemical Manufacturers
Association
(CMA) submits these comments on the draft “Guide to Minimize Microbial Food Safety
Hazards for Fresh Fruits and Vegetables” guidelines. The Panel is comprised of
members representing Vulcan Chemicals, Vulcan Chemical Technologies,
IDI/Englehard Corporation, Sterling Pulp Chemicals, Ashland Chemical Company and
Elf Atochem.
It is widely recognized that microbial loads can be quite high on fresh fruits and
vegetables due to exposure in the field, in transport and through handling and
processing. The problem has been well defined within the guidelines and we concur
that principles 1 through 8 in the guidance document are critical in reducing potential
microbial contamination and the subsequent health risks.
While the Panel supports certain aspects of these guidelines,
must be made:
●
the following points
Our largest concern with the proposed guidelines is the reference in footnote
7 to chlorine dioxide being unstable and explosive when concentrated.
Without providing a better explanation of the conditions necessary for this
compound to be unstable and explosive, this brief description would
undoubtedly alarm and confuse potential users of chlorine dioxide in
antimicrobial applications. A concentration of 109’ois the lower limit of the
explosivity of chlorine dioxide. Typical use concentrations of 1-5 ppm
(0.0001-0.0005%) are much lower than the lower limit and are completely
from explosive hazard. The Chlorine Dioxide Handbook, published by the
American Water Works Association, is an excellent source of information
concerning chlorine dioxide and safe handling.
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INNOVATION, TECHNOLOGY AND RESPONSIBLECARE@AT WORK
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1300
WILSON
BLVD.,
ARLINGTON,
VA
22209
● TELEPHONE
703-741-5600
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CMA Comments
Docket #97N-0451
June 29,1998
Page 2
●
●
The use of antirnicrobials to control pathogens in wash water and flume
water should be actively recommended rather than merely suggested. While
irrigation waters may play a role in microbial contamination, waters
associated with processing fruits and vegetables (especially wash water,
transport water and cooling waters) can be serious sources of contamination
and cross-contamination.
In many cases, these “early” waters are extensively
recycled, and can thus concentrate microbial contamination and organic
loads. High organic loads will serve to neutralize sanitizers added to these
waters and as a result, these waters can potentially become an inoculum to
the produce. In the case of flume, rinse and cooling waters used post
inoculum, it is critical to use antimicrobial treatments that are safe, but also
effective at low concentrations and against a broad spectrum of pathogens.
Footnote 6 in the guidance document states that there are 3 major groups of
chlorine compounds: liquid chlorine, hypochlorites and chlorine dioxide.
The inclusion of chlorine dioxide within a list of chlorine compound types is
not entirely accurate, since chlorine dioxide is not actually a “chlorinating
compound”. A more accurate listing of chlorine compounds would be,
gaseous chlorine (Clz), liquid chlorine (sodium hypochlorite), and powdered
chlorine (calcium hypochlorite).
The principal chemical reaction of chlorine
and other chlorinating compounds is electrophilic substitution, while that of
chlorine dioxide is primarily a simple oxidation.
.
In Footnote 7 of the guidelines, the statement is made that “Chlorine dioxide
may prove to be useful for washing intact fruits and vegetables at a
concentration not to exceed 5 ppm.” Chlorine dioxide in process waters of
fruits and vegetables has a long and highly successful history of use,
especially in recirculating water systems with high organic load, such as
flume and wash tanks. An expansion of this use, codified at 21 C.F.R.
~173.300 (b)(2), is anticipated to be published in June 1998 and will permit
the use of chlorine dioxide in water used to wash both cut and uncut fruits
and vegetables at a concentration not to exceed 3 ppm.
.
The following statement made in Footnote 7 of the guidelines needs
clarification: “additional research is needed to determine its effectiveness
against specific pathogens. ” The effectiveness of chlorine dioxide against
specific pathogens is well documented. There is a significant volume of
literature references and laboratory studies attesting to chlorine dioxide’s
potent and broad spectrum antimicrobial activity, including Escherichia. coli
0157:H7.
For example, a summary of chlorine dioxide’s abilities and its
effectiveness against a variety of pathogens maybe found in the draft
Alternative Disir@ecfarzts and Oxidants Guidance Manual, prepared for the EPA
Office of Groundwater and Drinking Water. In addition, there is ongoing
CMA Comments
Docket #97N-0451
June 29,1998
Page 3
research to document the effectiveness
Cryptosporidium parvum.
of chlorine dioxide against
The Panel supports the development of guidelines to minimize microbial food
safety hazards. Food safety is a critically important issue, and all available compounds
and techniques that can reduce or eliminate foodborne pathogens should be enlisted,
recommended and promoted. Within the rather small group of appropriate
antimicrobial compounds, chlorine dioxide has proven to be an excellent and
appropriate candidate due to its high activity at low concentrations, and its ability to
perform in high organic loads.
The Panel thanks you for this opportunity to provide comments and would be
happy to provide supporting documentation or additional technical information upon
your request. If you have any questions or comments, please call Ms. Marian Stanley of
my staff. Ms. Stanley is the Manager of the Chlorine Dioxide Panel and can be reached
at (703) 741-5623.
Sincerely yours,
Cqa,e
Courtney M. Price
Vice President, CHEMSTAR
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CMA
PAGE
6/30/98
CMA
1i 5
CmmE!i!l!:;’”s
Facsimile
Transmission
Name ............... Helen Harris
Company ......... FDA
MD 20852
Location ........... Rockville,
To
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Fax Number ..... 913018276870
Voice Number..3Ol -827-6860
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..... ‘a’k”s
From
Voice Number,. (703) 741-5624
1300 Wilson Boulevard
Arlington, VA 22209
VISIT OUR WEB SITE http://www.cmahq. corn/
Messaae or comment
...
Dear Ms. Harris,
The Chemical
Manufacturers
Association
attached comments to your office
June 26. Unfortunately
my office
address
and they
were
the
not delivered.
I spoke with Mr. Lyle Jaffey
it would
submitted
by Federal Express on Friday,
was not aware of your new
be alright to submit
the original copy delivered
business today.
this morning
the comments
by messenger
If you have any questions,
(703) 741-5625.
please
and he said that
today.
before
1 will have
close of
call Leyla Lange at
Regards,
Beth Walkos
Administrative
Assistant,
CHEMSTAR
Date and time of transmission: Tue 06/30/98
02:44PM
(Including this cover page)
Number of pages: 05
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ResponsibleCare”
A PWic Commitnmnt
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