[Federal Register Volume 67, Number 162 (Wednesday, August 21, 2002)]
[Notices]
[Pages 54203-54205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-21296]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0184; FRL-7194-7]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
for a Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket ID number OPP-2002-0184, must be 
received on or before September 20, 2002.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket ID 
number OPP-2002-0184 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Bipin Gandhi, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-8380; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket ID number OPP-2002-0184. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as confidential business information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. The public version of the official record, which 
includes printed, paper versions of any electronic comments submitted 
during an applicable comment period, is available for inspection in the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket ID number OPP-2002-0184 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs

[[Page 54204]]

(OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket ID number OPP-2002-0184. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person identified under FOR FURTHER INFORMATION 
CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains 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 support granting of the petition. Additional data 
may be needed before EPA rules on the petition.

List of Subjects

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

    August 12,2002.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by section 408(d)(3) of the FFDCA. The summary of the 
petition was prepared by the petitioner and represents the view of the 
petitioner. EPA is publishing the petition summary verbatim without 
editing it 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.

 Magna Bon Corporation

2E6476

    EPA has received a pesticide petition (2E6476) from Magna Bon 
Corporation, 1531 NW 25th Drive, Okeechobee, FL 34972 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 amending an 
established exemption from the requirement of a tolerance for sulfuric 
acid in 40 CFR 180.1001(c). Currently this tolerance exemption allows 
the use of sulfuric acid as an inert ingredient for pre-harvest and 
post-harvest uses with a limitation of 0.1% in the pesticide 
formulation when used as a pH control agent. This petition proposes to 
increase the limitation to 10% and to include a new use as a chelating 
agent. This petition also requests the establishment of an exemption 
from the requirement of a tolerance in plants and plants products, 
meat, milk, poultry, eggs, fish, shellfish, and irrigated crops when it 
results from the use of sulfuric acid as an inert ingredient in a 
pesticide product used in irrigation conveyance systems and lakes, 
ponds, reservoirs, or bodies of water in which fish or shellfish are 
cultivated.
    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 support granting of the petition. 
Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolism. Sulfuric acid is used to adjust the pH in 
water in mix tanks and will be continually used for other purposes, 
such as chelation, etc. In-can formulations also use sulfuric acid for 
the same reasons. The metabolism of sulfuric acid is well known in the 
literature (see Reregistration Eligibility Decision (RED)) FACTS, 
December 1993 - an EPA RED Fact Sheet which is available through EPA's 
pesticide website (http://www.epa.gov/pesticides). Sulfuric acid is 
already registered as an active ingredient (10%) on garlic and onion 
when used as an herbicide and for the purpose of defoliation of crop 
plants such as potatoes. The metabolism of sulfuric acid was examined 
at the time of reregistration. Sulfuric acid is also used as a 
sanitizer for food processing and dairy facilities, and equipment and 
utensils used in food and feed contact.
    The current exemption from the requirement of a tolerance in 40 CFR 
180.1001(c) describing the limitation for sulfuric acid as a inert in 
the ``formulated product'' should be changed to read 10% rather than 
the exemption from a tolerance at the level

[[Page 54205]]

of 0.1%. Any data in the existing files can be used to support this 
change in the ``formulated'' product. The use pattern should be changed 
from use only as a pH control agent to ``a chelating agent.'' People 
may be exposed to sulfuric acid in the formulated product. However this 
exposure involves such dilute solutions when in the ``final use 
dilution'' applied that it is believed inconsequential.
    The product will also be applied post-harvest and the sulfuric acid 
in a formulation will not affect the metabolism of harvested products. 
Sulfuric acid is already used to sanitize milk lines and food 
processing surfaces by wipe-on and CIP treatments. The use as an inert 
in formulations in the ``final use dilution'' will not increase risk 
when used in formulations applied to growing crops or to raw 
agricultural commodities after harvest, meat, milk, poultry, eggs, 
fish, shellfish, and irrigated crops. In addition, sulfuric acid can be 
used in formulations as an algaecide, herbicide, or fungicide in 
irrigation conveyance systems and lakes, ponds, reservoirs, or bodies 
of water which fish or shellfish are cultivated or the bodies of water 
to be used for drinking water.
    2. Analytical method. Standard methodology for sulfuric acid is 
adequate.
    3. Magnitude of residues. The sulfuric acid will be used in 
accordance with good agricultural practices and no residues are 
expected. The history of the compound suggests that the product is safe 
for use on or in products for uses on/in plants, animals, humans and 
potable water.
    Sulfuric acid will be applied as an inert ingredient according to 
labels approved by the EPA at rates reflected in a change in the 
wording of the tolerance exemption that reads 0.1% to 10.0%. The 
``final use dilution'' will contain considerably less sulfuric acid 
when applied to growing crops, post-harvest produce, drinking water, 
meat, milk, poultry, eggs, fish, shellfish, irrigated crops, conveyance 
systems, lakes, ponds, reservoirs, or bodies of water in which fish or 
shellfish are cultivated or water that is used for drinking water. 
Since the product is not systemic the product can be washed from the 
surface of the plant or animal parts before being consumed as the 
normal practice.

B. Toxicological Profile

    1. Acute toxicity. The toxicology of sulfuric acid is well-known. 
The toxicology file for registrations which use sulfuric acids as an 
active ingredient are available through EPA's data bases. In addition, 
EPA has issued a RED document: Mineral Acids, in 1994, which includes 
sulfuric acid. This document explored the toxicology profile of 
sulfuric acid. The website is: http://www.epa.gov/pesticides/reregistration/status.htm.
    The literature is full of references on the acute toxic effects of 
sulfuric acid. The data file for Magna Bon includes a toxicology study 
performed with sulfuric acid used as an inert at 4%. A material safety 
data sheet is available upon request.
    2. Genotoxicty. There is no known genotoxicity. All studies have 
been negative.
    3. Reproductive and developmental toxicity. There are no known 
effects on man or other animals.
    4. Subchronic toxicity. There are no known effects on man or other 
animals.
    5. Chronic toxicity. There are no known effects on man or other 
animals.
    6. Animal metabolism. There are no known adverse effects to 
animals.
    7. Metabolite toxicology. The metabolism of sulfuric acid is well 
known.
    8. Endocrine disruption. There are no known effects on man.

C. Aggregate Exposure

    1. Dietary exposure. Sulfuric acid is present in small amounts in 
every day living. Sulfur dioxide is present in air as the result of 
petro-chemical combustion. Sulfuric acid is formed as a result of the 
combination of water and sulfur dioxide in the air and is common in all 
metropolitan areas.
    Sulfuric acid being used as a crop protector or in a post-harvest 
application will add little exposure given the current exposure.
    Although there are no guideline studies for this data requirement 
per se, there is adequate information in the extensive open literature 
on sulfuric acid to characterize its toxicity.
    In addition, sulfuric acid is Generally Recognized as Safe (GRAS) 
by the U.S. Food and Drug Administration.
    i. Food. The total consumption of agricultural products, fish, 
shell-fish, and meat treated with sulfuric acid 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 is requested in 
potable water at a level of 0.1 ppm maximum.
    2. Non-dietary exposure. The population is exposed to sulfuric acid 
on an almost daily basis. Dermal exposure is the most prevalent.

D. Cumulative Effects

    There are no cumulative effects. The amount of sulfuric acid used 
to treat the plants, 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 sulfuric acid will reduce costs of 
protecting the above-mentioned products and giving adequate protection 
to such 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. Sulfuric 
acid food products will be washed. The foods are normally further 
processed with the result of little or no detectable levels of sulfuric 
acid.

F. International Tolerances

    The countries of the world have not restricted sulfuric acid for 
the purposes requested.
[FR Doc. 02-21296 Filed 8-20-02; 8:45 am]
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