[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: [email protected]. 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: 
[email protected].
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-D[email protected]


    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