[Federal Register Volume 62, Number 38 (Wednesday, February 26, 1997)]
[Notices]
[Pages 8734-8735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4626]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-706; FRL-5585-7]
Bioxy, Inc.; Pesticide Tolerance Petition Filing
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of filing.
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SUMMARY: This notice annonces the filing of a pesticide petition
proposing the exemption from the requirement of a tolerance for sodium
chlorite residues in or on meat and meat byproducts of cattle, sheep,
hogs, goats, horses, and poultry when applied as a bactericide for the
generation of chlorine dioxide in livestock drinking water.
DATES: Comments, identified by the docket control number PF-706, must
be received on or before, March 28, 1997.
ADDRESSES: By mail, submit written comments to Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St. SW.,
Washington, DC 20460. In person, bring comments to Rm. 1132, CM #2.
1921 Jefferson Davis Highway, Arlington, VA 22202.
Comments and data may also be submitted electronically be sending
electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be
accepted on disks in WordPerfect 5.1 file format or ASCII file format.
All comments and data in electronic form must be identified by docket
control number PF-706. Electronic comments on this notice may be filed
online at many Federal Depository Libraries. Additional information on
electronic submissions can be found in Unit II. of this document.
Information submitted as comments concerning this document may be
claimed confidential by marking any part or all of that information as
``Confidential Business Information'' (CBI). CBI should not be
submitted through e-mail. Information marked as CBI will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2. A copy of the comment that does not contain CBI must be submitted
for inclusion in the public record. Information not marked confidential
may be disclosed publicly by EPA without prior notice. All written
comments will be available for public inspection in Rm. 1132 at the
address given above, from 8:30 a,.m. to 4 p.m., Monday through Friday,
excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: Vivian A. Turner, Acting Product
Manager (PM) 32, Registration Division (7505C), Rm., 237, Crystal Mall
#2, Jefferson Davis Highway, Arlington, VA. 703-305-7460. e-mail:
turner.vivian@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition (PP
6F4783) from Bioxy, Inc. proposing, pursuant to section 408(d) of the
Federal Food, Drug and Cosmetic Act, (FFDCA) 21 U.S.C. 346a(d), to
amend 40 CFR part 180 by establishing an exemption from tolerance for
residues of sodium chlorite and its hydrolysis by-product, chlorine
dioxide, in or on meat and meat byproducts of cattle, sheep, goats,
horses and poultry when such residues result from the use of sodium
chlorite to generate the bactericide, chlorine dioxide, in poultry
drinking water and livestock drinking water at a concentration of up to
18.34 parts per million (ppm). The proposed analytical method is
ultraviolet spectrophotometric analysis. Pursuant to the section
408(d)(2)(A)(i) of the FFDCA, as amended, Bioxy, Inc. has submitted the
following summary of information, data and arguments in support of
their pesticide petition. This summary was prepared by Bioxy, Inc. and
EPA has not fully evaluated the merits of the petition. EPA edited the
summary to clarify that the conclusions and arguments were the
petitioner's and not necessarily EPA's and to remove certain extraneous
material.
I. Petition Summary
This section has been arranged to provide a justification for this
tolerance exemption and a summary of available data.
The request is to exempt from the requirement of a tolerance,
residues of sodium chlorite and its hydrolysis product, chlorine
dioxide, in or on meat and meat byproducts of cattle, sheep, hogs,
goats, horses, and poultry, and milk and eggs when such residues result
from the use sodium chlorite to generate the bactericide, chlorine
dioxide in poultry drinking water and livestock drinking water.
EPA has exempted sodium chlorite from the requirement of a
tolerance when used as a seed-soak treatment of the raw agricultural
commodities (RACs) crop group Brassica (cole) leafy vegetables and
radishes (40 CFR 180.170). Sodium chlorate is chemically similar to
sodium chlorite, and sodium chlorate is exempt from the requirement of
a tolerance when used as a defoliant, desiccant, or fungicide on
various RACs (40 CFR 180.1020). Chlorine gas is exempted from the
requirement of a tolerance when used pre- or post-harvest in solution
on all RACs (40 CFR 180.1095). Calcium hypochlorite is exempted from
the requirement of a tolerance when used harvest or postharvest on all
RACs and in or on grapes when used as a fumigant
[[Page 8735]]
postharvest by means of a chlorine generator pad (40 CFR 180.1054). The
Agency has determined previously (as stated in the proposal for
exemption from the requirement of a tolerance for calcium hypochlorite
chlorine gas in the Federal Register of January 11, 1991 (56 FR 1153;
FRL-3686-5), that there is no reasonable expectation that residues of
these compounds will remain in eggs, meat, milk or poultry in
accordance with 40 CFR 180.3. The residues which do remain are not of
toxicological significance.
A. Residue Chemistry
Residues of sodium chlorite are not expected in livestock because
it converts to chlorine dioxide in the drinking water and is consumed
by biological activity. Because sodium chlorite is highly reactive with
minerals, bacteria and other contaminants, the reaction is complete
within a few minutes consuming most, if not all of the sodium chlorite.
Because there are many active Federal pesticide registrations for
sodium chlorite and chlorine dioxide as well as existing tolerance
exemptions for both compounds, the Agency has determined that the
residue chemistry for these compounds is understood.
Adequate analytical methodology is available through
spectrophotometric analysis to determine the amounts of sodium chlorite
in livestock drinking water.
B. Toxicological Profile
The acute and chronic toxicity of sodium chlorite and chlorine
dioxide have been tested extensively. Adverse effects are not expected
when used in the proposed manner.
C. Aggregate Exposure
There are no established U.S. tolerances for sodium chlorite or
chlorine dioxide; however, there are several tolerance exemptions for
theses compounds. The addition to aggregate exposure or sodium chlorite
or chlorine dioxide as described in this petition is minimal.
The estimated non-occupational exposure to sodium chlorite and
chlorine dioxide has been evaluated based on its proposed use pattern.
The potential for non-occupational exposure under the proposed use to
the general population is unlikely. Sodium chlorite and its hydrolysis
product, chlorine dioxide, is proposed to be used only on poultry and
livestock farms and is not to be used in or around the home.
There is no maximum contaminant level for residues of sodium
chlorite in drinking water; however, there is a proposed maximum
residual disinfectant level (MRDL) for chlorine dioxide of 0.8
milligrams per liter (mg/L) and a MRDL goal of 0.3 mg/L. The MRDL was
part of a proposed EPA rulemaking on disinfectants on drinking water on
July 29, 1994; however, this rule is not yet finalized.
D. Cumulative Effects
Sodium chlorate is chemically similar to sodium chlorite, and
sodium chlorate is exempt from the requirements of a tolerance when
used as a defoliant, desiccant, or fungicide on various RACs (40 CFR
180.1020). Chlorine gas is exempted from the requirement of a tolerance
when used preharvest or postharvest in solution on all RACs (40 CFR
180.1095). Calcium hypochlorite is exempted from the requirement of a
tolerance when used preharvest or postharvest on all RACs and in or on
grapes when used as a fumigant postharvest by means of a chlorine
generator pad (40 CFR 180.1054). The agency has determined previously
that there is no reasonable expectation that residues of these
compounds will remain in eggs, meat, or poultry in accordance with 40
CFR 180.3. The residues which do remain are not of toxicological
significance.
E. Safety Determination
Because sodium chlorite and chlorine dioxide are not expected to
accumulate in poultry or livestock tissues and their food byproducts,
exposure to the U.S. population and the subgroup infants and children
does not pose a significant risk. In addition, chlorine dioxide (the
byproduct from the reaction during the proposed use of sodium chlorite)
is already present in many municipal drinking water systems, therefore,
the exposure to any chlorine dioxide that may be present in animal food
products as a result of the proposed use is not expected to cause any
additional risk to the general population and the subgroup of infants
and children.
F. International Tolerances
The petitioner understands that there are no current established
Maximum Residue Levels for sodium chlorite or chlorine dioxide.
II. Public Record
Interested persons are invited to submit comments on the this
notice of filing. Comments must bear a notation indicating the docket
control number, PF-706.
A record has been established for this notice under docket control
number PF-706 including comments and data submitted electronically as
described below). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 1132 of the Public Response and Program
resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2,
1921 Jefferson Davis highway, Arlington, VA.
Electronic comments can be sent directly to EPA at:
opp-Docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer all comments received electronically into printed,
paper form as they are received and will place the paper copies in the
official rulemaking record which will also include all comments
submitted directly in writing. The official rulemaking record is the
paper record maintained at the Virginia address in ``ADDRESSES'' at the
beginning of this document.
List of Subjects
Environmental Protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: February 13, 1997.
Peter Caulkins,
Acting Director, Registration Division, Office Pesticide Programs.
[FR Doc. 97-4626 Filed 2-25-97; 8:45 am]
BILLING CODE 6560-50-F
