[Federal Register Volume 60, Number 42 (Friday, March 3, 1995)]
[Rules and Regulations]
[Pages 11898-11901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-5275]
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[[Page 11899]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 173
[Docket No. 93F-0483]
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 chlorine dioxide to
control the microbial population in poultry process water. This action
is in response to a petition filed by Rio Linda Chemical Co., Inc.
DATES: The regulation is effective March 3, 1995; written objections
and requests for a hearing by April 3, 1995. The Director of the Office
of the Federal Register approves the incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of certain
publications in new Sec. 173.69, effective March 3, 1995.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Robert L. Martin, Center for Food
Safety and Applied Nutrition (HFS-217), Food and Drug Administration,
200 C St. SW., Washington, DC 20204-0001, 202-418-3074.
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal Register of February 2, 1994
(59 FR 4924), FDA announced that a food additive petition (FAP 4A4408)
had been filed by Rio Linda Chemical Co., Inc., 410 North 10th St.,
Sacramento, CA 95814, proposing that the food additive regulations be
amended to provide for the safe use of chlorine dioxide to disinfect
waters contacting fresh meat, fresh poultry, processed meat, and
processed poultry. Since filing the petition, the agency has concluded
that it is more appropriate to replace the term ``disinfect'' with
``control the microbial population'' because ``disinfect'' implies
total eradication of microbial contamination.
FDA has completed its review of the use of up to 3 parts per
million (ppm) residual chlorine dioxide in process water contacting
whole fresh poultry carcasses. The agency is issuing this regulation to
permit this use while its review of the other proposed uses of chlorine
dioxide continues.
II. Chlorine Dioxide
Chlorine dioxide (CAS Reg. No. 10049-04-4) is a yellow to reddish-
yellow gas with a pungent odor similar to that of chlorine. Because
chlorine dioxide is explosive when concentrated, it is usually
generated at the site where it is used. Chlorine dioxide can be
prepared by reaction of chlorine with sodium chlorite, reduction of
sodium chlorate, or acidification of sodium chlorite. High yield
production of chlorine dioxide (greater than 90 percent) is
accomplished by reaction of sodium chlorite with chlorine or by
reaction of an acid, sodium hypochlorite, and sodium chlorite (Ref. 1).
Chlorine dioxide is a strong oxidant which is expected to react
with microbial contaminants and other organic material present in
poultry process water. Oxidation of chlorine dioxide results in the
formation of chlorite ion, which is an oxidant that is capable of
reacting with organic material in poultry process water. Residual
chlorate present as an impurity in chlorine dioxide solutions can also
act as an oxidant.
Chlorine dioxide is currently listed in 21 CFR 178.1010(b)(34) as a
component of a sanitizer solution. Chlorine dioxide is also listed in
21 CFR 137.105 for use as a bleaching agent for flour and is also
approved by the Environmental Protection Agency (EPA) for use in
potable water treatment plants (40 CFR part 141, subpart H). The Health
Protection Branch of Health and Welfare Canada has stated in a letter
to the petitioner that chlorine dioxide is permitted for use in poultry
chiller water in Canada (Ref. 2).
Chlorine dioxide is a potential substitute for chlorine, which is
currently commonly used in poultry processing. Published studies that
were included in the petition show that chlorine dioxide is four to
seven times more effective than an equal concentration of chlorine as a
bactericide in poultry chiller water (Refs. 3, 4, and 5). Thus,
chlorine dioxide can be used at considerably lower levels than chlorine
without compromising bactericidal effects. Most of the studies
conducted by the petitioner were with residual chlorine dioxide levels
in the process water of 3 ppm.
III. Safety
Data from the gas chromatographic-mass spectroscopic analysis of
poultry process water containing 3 ppm of chlorine dioxide were
provided in the petition. These data show that organic reaction
byproducts, such as the potentially toxic trihalomethanes (e.g.,
chloroform), are not present in poultry process water at the 0.2 parts
per billion (ppb) limit of detection when the method for detecting
chloroform is used. (EPA proposed a drinking water standard (59 FR
38668 at 38670, July 29, 1994) that permits a maximum contaminant level
of up to 80 ppb (400 times the amount detectable by the analytical
method) of ``total trihalomethanes'' (chloroform, bromoform,
dibromochloromethane and bromodichloromethane) in drinking water.)
Moreover, FDA's review of the results of an Ames test on poultry
process water that was treated with 20 ppm chlorine dioxide revealed no
mutagenic activity. The Ames test results support the conclusion that
significant levels of harmful organic reactions byproducts will not be
formed when chlorine dioxide, at a residual level of 3 ppm, is used as
the bacteriocidal agent in poultry process water.
In addition to evaluating the probable formation of organic
reaction byproducts from the use of chlorine dioxide in poultry process
water, FDA has also evaluated the possible presence of residual
chlorine dioxide, chlorite, and chlorate on treated poultry carcasses;
the potential for the oxidation of poultry tissue, including sensitive
fatty acids; and data from mutagenicity tests.
Based on its evaluation of the information in the petition, the
agency has concluded that no detectable residues of chlorine dioxide
would remain on poultry carcasses, and that exposure to chlorite and
chlorate as a result of this use of chlorine dioxide would be virtually
nil. (No chlorite or chlorate could be detected on poultry (raw or
cooked) at the limit of detection (50 ppb) for the method used.) The
agency also concluded that the very low levels of chlorite and chlorate
that may be retained on poultry carcasses as a result of exposure to
chlorine dioxide-containing process water would be converted to
correspondingly low levels of chloride (a relatively innocuous
substance, e.g., chloride in table salt) during cooking (Ref. 6).
FDA also considered potential oxidative effects of chlorine
dioxide, chlorite, and chlorate on poultry. The agency reviewed
information in the [[Page 11900]] petition on thiobarbituric acid (TBA)
values of raw and cooked poultry exposed to chlorine dioxide-containing
process water. A TBA test is commonly used as an indicator of oxidative
decomposition (and of rancidity) of meat and fat. The more oxidative
decomposition, the higher the TBA values. The agency determined that
the TBA values for both raw and cooked poultry exposed to chlorine
dioxide-containing process water did not significantly differ from that
for poultry exposed to tap water. Thus, the agency concludes that no
significant oxidation of poultry exposed to chlorine dioxide-containing
process water occurs under the prescribed conditions of use.
FDA also evaluated information in the petition on the levels of
oxidation-sensitive fatty acids (e.g., oleic, linoleic, linolenic, and
arachidonic acid) in raw untreated poultry and in poultry exposed to
chlorine dioxide-containing process water. Fatty acid profiles were
comparable for treated and untreated poultry when analyzed by gas
chromatography. FDA concludes that exposure to chlorine dioxide at
levels 7 to 10 times higher than that prescribed in the proposed
regulation does not result in appreciable loss of these fatty acids
from poultry.
Based on the above findings, the agency concludes that 3 ppm of
residual chlorine dioxide in poultry process water will not result in a
measurable increase in oxidation of poultry as compared with poultry
exposed to tap water.
The agency also considered the possibility of formation of
mutagenic compounds in poultry and poultry process water treated with
chlorine dioxide. Ames test information presented in the petition
showed no evidence of mutagenic activity in poultry process water
treated with chlorine dioxide. Thus, the agency concludes that the use
of chlorine dioxide in poultry process water under the conditions
prescribed in the regulation should not pose a significant health
concern from the formation of mutagenic substances.
IV. Conclusions
FDA has evaluated the data in the petition and other relevant
material and has consulted with scientists in the Food Safety and
Inspection Service in the U. S. Department of Agriculture concerning
the technological and practical aspects of the proposed use of chlorine
dioxide. Based upon this evaluation, the agency concludes that the
proposed use of the additive is safe and will have the intended
technical effect. The agency also concludes that a specification for
minimum purity of chlorine dioxide should be included in the regulation
to reflect the purity of the chlorine dioxide that it evaluated.
Therefore, 21 CFR part 173 is amended as set forth below.
V. Inspection of Documents
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 21 CFR
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.
VI. Environmental Imapct
The agency has carefully considered 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.
VII. Objections
Any person who will be adversely affected by this regulation may at
any time on or before April 3, 1995, file with the Dockets Management
Branch (address above) written objections thereto. 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 shall be
submitted and shall 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.
VIII. 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. Kirk-Othmer Encyclopedia of Chemical Technology, Vol. 5, pp.
612-632.
2. Letter dated July 30, 1991, to Dr. Richard Higby from J. W.
Salminen, Health Protection Branch, Health and Welfare Canada.
3. Lillard, H. S., ``Levels of Chlorine and Chlorine Dioxide of
Equivalent Bactericidal Effect in Poultry Processing Water,''
Journal of Food Science, 44:1594-1597, 1979.
4. Lillard, H. S., ``Effect on Broiler Carcasses and Water of
Treating Chiller Water with Chlorine or Chlorine Dioxide,'' Poultry
Science, 59:1761-1766, 1980.
5. Thiesson, G. P., W. R. Usborne, and H. L. Orr, ``The Efficacy
of Chlorine Dioxide in Controlling Salmonella Contamination and Its
Effect on Product Quality of Chicken Broiler Carcasses,'' Poultry
Science 63:647-653, 1984.
6. Gordon, G., R. G. Kieffer, and D. H. Rosenblatt, ``The
Chemistry of Chlorine Dioxide'' in Progress in Inorganic Chemistry,
Vol. 15, pp. 201-286, S. J. Lippard, ed., Wiley-Interscience, New
York, 1972.
List of Subjects in 21 CFR Part 173
Food additives, Incorporation by reference.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 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: Secs. 201, 402, 409 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 342, 348).
2. New section 173.69 is added to read as follows:
Sec. 173.69 Chlorine dioxide.
Chlorine dioxide (CAS Reg. No. 10049-04-4) may be safely used in
food in accordance with the following prescribed conditions:
(a) The additive is generated by treating an aqueous solution of
sodium chlorite with either chlorine gas or a mixture of sodium
hypochlorite and hydrochloric acid. The generator effluent contains at
least 90 percent (by weight) of chlorine dioxide with respect
[[Page 11901]] to all chlorine species as determined by Method 4500-
ClO2 E in the ``Standard Methods for the Examination of Water and
Wastewater,'' 18th ed., 1992, or an equivalent method. Method 4500-
ClO2 E is incorporated by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies are available from the Division of
Petition Control, Center for Food Safety and Applied Nutrition (HFS-
215), Food And Drug Administration, 200 C St., SW., Washington, DC
20204-0001 and The American Public Health Association, 1015 Fifteenth
St., NW., Washington, DC 20005, or may be examined at the Office of the
Federal Register, 800 North Capitol St., NW., suite 700, Washington,
DC.
(b) The additive may be used as an antimicrobial agent in water
used in poultry processing in an amount not to exceed 3 parts per
million (ppm) residual chlorine dioxide as determined by Method 4500-
ClO2 E referenced above or an equivalent method.
Dated: February 23, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-5275 Filed 3-2-95; 8:45 am]
BILLING CODE 4160-01-F
