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copper sulfate (Bluestone) Pesticide Petition Filing 6/99



[Federal Register: July 14, 1999 (Volume 64, Number 134)]
[Notices]               
[Page 37972-37977]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jy99-106]                         

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ENVIRONMENTAL PROTECTION AGENCY

[PF-877; FRL-6085-5]

 
Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of pesticide 
petitions proposing the establishment of regulations for residues of 
certain pesticide chemicals in or on various food commodities.
DATES: Comments, identified by the docket control number [PF-877], must 
be received on or before August 13, 1999.
ADDRESSES: By mail submit written comments to: Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502C), Office of Pesticides 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.
    Comments and data may also be submitted electronically by following 
the instructions under ``SUPPLEMENTARY INFORMATION.'' No confidential 
business information (CBI) should be submitted through e-mail.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all of that information as 
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: The product manager listed in the 
table below:

[[Page 37973]]



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                                   Office location/
        Product Manager            telephone number          Address
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Eugene Wilson.................  Rm. 235, CM #2, 703-    1921 Jefferson
                                 305-6103, e-            Davis Hwy,
                                 mail:wilson.eugene@ep   Arlington, VA
                                 a.gov.
James A. Tompkins.............  Rm. 239, CM #2, 703-
                                 305-5697, e-mail:
                                 tompkins.james@epa.go
                                 v.
Bipin Gandhi..................  Rm. 713J, CM #2 703-    Do.
                                 308-8380, e-
                                 mail:gandhi.bipin@epa
                                 .gov.
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SUPPLEMENTARY INFORMATION: EPA has received pesticide petitions as 
follows proposing the establishment and/or amendment of regulations for 
residues of certain pesticide chemicals in or on various food 
commodities under section 408 of the Federal Food, Drug, and Comestic 
Act (FFDCA), 21 U.S.C. 346a. EPA has determined that these petitions 
contain data or information regarding the elements set forth in section 
408(d)(2); however, EPA has not fully evaluated the sufficiency of the 
submitted data at this time or whether the data supports granting of 
the petition. Additional data may be needed before EPA rules on the 
petition.
    The official record for this notice of filing, as well as the 
public version, has been established for this notice of filing under 
docket control number [PF-877] (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 official record is located at the address in 
``ADDRESSES'' at the beginning of this document.
    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. Comment 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 the docket number [PF-877]) and appropriate petition 
number. Electronic comments on this notice may be filed online at many 
Federal Depository Libraries.

List of Subjects

    Environmental protection, Agricultural commodities, Food additives, 
Feed additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

Dated: June 25,1999.

    James Jones,

Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

    Petitioner summaries of the pesticide petitions are printed below 
as required by section 408(d)(3) of the FFDCA. The summaries of the 
petitions were prepared by the petitioners and represent the views of 
the petitioners. EPA is publishing the petition summaries verbatim 
without editing them in any way. The petition summary announces the 
availability of a description of the analytical methods available to 
EPA for the detection and measurement of the pesticide chemical 
residues or an explanation of why no such method is needed.


3. Magna Bon Corporation

 PP 8F4982

    EPA has received a pesticide petition [PP 8F4982] from Magna Bon 
Corporation, 3213 Ocean Drive, Vero Beach, FL 32963 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 to establish an exemption 
from the requirement of a tolerance for copper sulfate pentahydrate on 
the RAC copper sulfate pentahydrate at 0.050 ppm. EPA has determined 
that the petition contains data or information regarding the elements 
set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully 
evaluated the sufficiency of the submitted data at this time or whether 
the data supports granting of the petition. Additional data may be 
needed before EPA rules on the petition.

 A. Residue Chemistry

    1. Plant metabolism. Copper sulfate pentahydrate has been used for 
years as a micronutrient, added to soils for up-take-into plants for 
sustaining vigorous growth. The metabolism is well-known in plant 
physiology as a vital component of plant growth. The labeled rate will 
not exceed any applications given during growth. The product will be 
applied post-harvest and no additional metabolism of harvested products 
is expected.
    2. Analytical method. Standard methodology for copper sulfate is 
adequate.
    3. Magnitude of residues. The cover letter (attached) notes the 
various clearances based on uses in plants, animals, humans and potable 
water.
    The products will be applied according to labels approved by EPA 
which are at or below the levels on the current labeled rates for 
application to growing crops. The plants will only be exposed to washes 
of the product. Since the product is not systemic, the product can be 
washed from the surface of the plant or animal parts before being 
consumed.

B. Toxicological Profile

    The toxicology of copper compounds are well-known. The toxicology 
file for Mega Bon Corporation registrations are incorporated by 
reference.
    1. Acute toxicity. Copper and the salts are solids. Individuals use 
copper bracelets, and chains in contact with their skin as jewelry. 
There is no known skin sensitization. Please refer to 21 CFR 184.1261 
when used as a human supplement.
    2. Genotoxic. There is no known genotoxicity. All studies have been 
negative.
    3. Reproductive and developmental toxicity.<SUP>1</SUP>
    4. Subchronic toxicity.<SUP>1</SUP>
    5. Chronic toxicity.<SUP>1</SUP>
    6. Animal metabolism.<SUP>1</SUP>
    7. Metabolite toxicology.<SUP>1</SUP>

    1Although there are no guidline studies for this data 
requirement per se, there is adequate information in the extensive 
open literture on copper sulfate to characterize its toxicity.
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 C. Aggregate Exposure

    1. Dietary exposure. Copper is used in vitamins and occurs on a 
very small part of the daily foods. However, the small amount that may 
occur on plants is washed off prior to food preparation.
    Copper being used as a crop protector or as a post-harvest 
application may add little to the exposure given the use pattern and 
general application of new fungicides.
    i.  Food. The total consumption of all agricultural, fish, shell-
fish, and meat treated with copper sulfate pentahydrate can be 
calculated as being at or below daily minimums of mineral requirements 
for humans. In addition, the plant and meat products are washed before 
cooking.
    ii. Drinking water. A food additive tolerance of 2 ppm in potable 
water is established under 40 CFR 185.1200 for residues of copper from 
use of copper compounds.
    2. Non-dietary exposure. The population is exposed to copper 
compounds on an almost daily basis. Dermal exposure is the most 
prevalent. There have been several impingements by the copper compounds 
with little to no effect.

 D. Cumulative Effects

    The amount of copper sulfate pentahydrate used to treat the 
harvested plant products, fish, shellfish, poultry, and meat would be a 
way of lowering bacterial, fungi and even-viral organisms from becoming 
a problem under most circumstances.

 E. Safety Determination

    1.  U.S. population. Using the copper sulfate pentahydrate would 
reduce costs of protecting the above-mentioned products and giving 
adequate protection to such target post-harvested crops, fish, 
shellfish, poultry, and meat products without harm to humans, animals, 
plants, plant products, and the environment.
    2. Infants and children. Foods are washed and processed. Copper 
sulfate pentahydrate is a solid, but will be washed. The foods are 
further processed with little or no detectable levels. The copper in 
the application is a vital nutrient for infants and children.

 F. International Tolerances

    The countries of the world have not restricted copper for the 
purposes we request.


[FR Doc. 99-17317 Filed 7-13-99; 8:45 am]
BILLING CODE 6560-50-F