[Federal Register Volume 69, Number 34 (Friday, February 20, 2004)]
[Notices]
[Pages 7946-7949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-3718]



[[Page 7946]]

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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0017; FRL-7343-4]


Potassium Dihydrogen Phosphate; 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 identification (ID) number OPP-
2004-0017, must be received on or before March 22, 2004.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Driss Benmhend, Biopesticides and 
Pollution Prevention Division (7511C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-9525; e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     Pesticide manufacturing (NAICS 32532)
    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 this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
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 Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket ID number OPP-2004-0017. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. This 
docket facility is open from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The docket telephone number is (703) 
305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
    Certain types of information will not be placed in EPA's Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is available for viewing in EPA's electronic public docket. 
Although not all docket materials may be available electronically, you 
may still access any of the publicly available docket materials through 
the docket facility identified in Unit I.B.1. EPA intends to work 
towards providing electronic access to all of the publicly available 
docket materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk

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or CD ROM you submit, and in any cover letter accompanying the disk or 
CD ROM. This ensures that you can be identified as the submitter of the 
comment and allows EPA to contact you in case EPA cannot read your 
comment due to technical difficulties or needs further information on 
the substance of your comment. EPA's policy is that EPA will not edit 
your comment, and any identifying or contact information provided in 
the body of a comment will be included as part of the comment that is 
placed in the official public docket, and made available in EPA's 
electronic public docket. If EPA cannot read your comment due to 
technical difficulties and cannot contact you for clarification, EPA 
may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2004-0017. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID Number OPP-2004-0017. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2004-0017.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket 
ID Number OPP-2004-0017. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is 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 docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed 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 FFDCA 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.

    Dated: February 5, 2004.
 Sheryl K. Reilly,
Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.

Summary of Petition

    The petitioner's summary of the pesticide petition is printed below 
as required by FFDCA section 408(d)(3). The summary of the petition was 
prepared by the petitioner and represents the view of the petitioner. 
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.

Cal Agri Products, LLC

PP 3F6793

    EPA has received a pesticide petition 3F6793 from Cal Agri 
Products, LLC, 10720 McCune Avenue, Los Angeles, CA 90034, proposing 
pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 
CFR part 180 to establish an amendment/expansion of an existing 
tolerance exemption for the biochemical pesticide potassium dihydrogen 
phosphate.
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, Cal 
Agri Products, LLC has submitted the following summary of information, 
data, and arguments in support of their

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pesticide petition. This summary was prepared by Cal Agri Products, LLC 
and EPA has not fully evaluated the merits of the pesticide petition. 
The summary may have been edited by EPA if the terminology used was 
unclear, the summary contained extraneous material, or the summary 
unintentionally made the reader conclude that the findings reflected 
EPA's position and not the position of the petitioner.

A. Product Name and Proposed Use Practices

    Cal Agri Products, LLC has filed a petition for the extension of 
the existing exemption from the requirement of a tolerance for residues 
in or on growing crops and raw agricultural commodities for potassium 
dihydrogen phosphate (KDP), also known as monopotassium phosphate, to 
include uses as an active ingredient for insect control. KDP is a 
ubiquitous element in nature and is a common ingredient in many 
consumer and industrial products used worldwide. KDP is an important 
nutrient supplement for human health and a common ingredient in 
pharmaceuticals, food processing and manufacturing. KDP is categorized 
as a generally recognized as safe (GRAS) compound (21 CFR 182.1073), 
with minimal risks associated with acute and chronic human exposure 
when used in accordance with good manufacturing practices. In addition 
to food applications, KDP is also a common ingredient in many 
agricultural fertilizers and pesticides. Currently, KDP is registered 
as an active ingredient in three reduced-risk fungicides (EPA No. 
70644-1, 70644-4 and 42519-24) and is exempt from the requirement of a 
food tolerance under 40 CFR 180.1193, when applied as fungicide in 
accordance with good agricultural practices. KDP is also exempt from 
the requirement of a food tolerance under 40 CFR 180.1001 (c) and (e) 
when used as an inert ingredient in pesticide formulations.
    KDP is formulated as a pesticide active ingredient and has been 
shown to operate as an effective non-toxic control agent of a number of 
agriculturally important insect pests and pathogens. The pesticide 
formulation utilizing KDP operates through a non-toxic physical mode of 
action that effects the insects' protective coating making them 
vulnerable to disruption and desiccation from the KDP active 
ingredient. Use patterns for KDP will include foliar applications to 
food and non-food crops for the control of soft-bodied insects, such as 
aphids and whiteflies, and foliar pathogens, such as powdery mildew. 
Proposed uses will also include soil drenches for the control of soil 
dwelling pathogens. The pesticide formulation will be diluted with 
water for a use rate of 2,000 to 4,000 parts per million (ppm) (20 to 
50 ppm of KDP). Use patterns will include application on agricultural 
food crops, ornamental and nursery crops grown in fields and 
greenhouses. Use of the pesticide formulation containing KDP as an 
active ingredient may be an effective substitute for some highly toxic 
pesticides (such as some organophosphates) that are currently used to 
control some of these same pests.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. Potassium 
dihydrogen phosphate (CAS No. 7778-77-0), also known as monopotassium 
phosphate, is a phosphate and potassium salt compound and described by 
the empirical formula KH2PO4. KDP is produced 
through the electrolysis of potassium chloride, which in turn, is 
reacted with phosphoric acid. KDP is an ingredient widely used in 
processing foods for animal and human consumption and in other consumer 
products including detergents, creams, lotions, foods, shampoos, and 
toothpaste. KDP is the active ingredient in three previously registered 
pesticides (EPA No. 70644-1, 70644-2 and 42519-24) applied for the 
control of powdery mildew.
    2. Magnitude of residue at the time of harvest and method used to 
determine the residue. Residues of KDP are projected to be negligible 
because of the small amounts applied and the rapid absorption by plants 
and biodegradability of this compound.
    3.A statement of why an analytical method for detecting and 
measuring the levels of the pesticide residue are not needed. KDP has 
been approved by the U.S. Food and Drug Administration (FDA) for use as 
a food additive and is categorized as a GRAS compound under 21 CFR 
182.1073. Consumption of KDP in the typical diet and environmental 
exposure to KDP is far in excess of any residuals expected to be found 
on or in food crops from the use of KDP at the rates proposed as a 
fungicide or insecticide. EPA in granting an exemption from the 
requirement of a tolerance for KDP. EPA has determined that no harm 
will result from aggregate exposure to KDP when use as an active 
ingredient in fungicide formulations or an inert ingredient in other 
pesticide formulations. Therefore no analytic method for detecting 
residues of KDP is required.

C. Mammalian Toxicological Profile

    KDP has been approved by the FDA for use as a food additive and is 
categorized as a GRAS compound under 21 CFR 182.1073. It is a common 
component of many consumer products in the United States and most 
industrial nations. In 1998, under the initiative of EPA, KDP was 
listed as exempt from the requirement of a food tolerance when used as 
a fungicide (40 CFR 180.1193) and additionally, is listed as exempt 
from the requirement of a food tolerance when used as an inert 
ingredient in pesticide formulations (40 CFR 180.1001 (c) and (e)). EPA 
concluded, based on the available scientific information coupled with a 
lack of reported adverse effects, that KDP does not pose an 
unreasonable risk to human health or the environment.
    1. Acute toxicity. KDP has been extensively studied in animal and 
human studies in both short-term and long-term trials (sub-acute to 
chronic exposure). Studies have demonstrated an acute oral toxicity 
lethal dose (LD)50 500 milligrams/kilogram (mg/
kg) in female rats, LD50 5,000 mg/kg in male rats 
and LD50 4,640 mg/kg for rats (toxicity category 
III) and an acute dermal toxicity lethal dose LD50 = 2,000 
mg/kg for rabbits (toxicity category III). It has also been determined 
to be non-irritating to skin in rabbits (toxicity category IV) and a 
mild eye irritant (toxicity category III). Human experience with KDP 
has demonstrated that consumption of phosphorus from 30 mg/kg/day to a 
maximum of 70 mg/kg/day can be tolerated without adverse affect. The 
FDA recommended daily value of potassium intake is 3,500 mg/day.
    2. Genotoxicity. There is no evidence of genetoxicity from exposure 
to KDP. EPA in granting an exemption from tolerance for KDP when used 
as a fungicide, waived requirement of further testing to determine 
genotoxicity because of low mammalian toxicity and no reports of 
adverse effects.
    3. Reproductive and developmental toxicity. There is no evidence of 
reproductive or developmental toxicity from exposure to KDP. EPA in 
granting an exemption from the requirement of a tolerance for KDP when 
used as a fungicide, waived requirement of further testing to determine 
reproductive and developmental toxicity because of low mammalian 
toxicity and no reports of adverse effects.
    4. Subchronic toxicity. KDP disassociates into potassium and 
phosphorus ions which are both essential nutrients in mammals. EPA in

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granting an exemption from tolerance for KDP when used as a fungicide, 
waived requirement of further testing to determine subchronic toxicity 
because of low mammalian toxicity and no reports of adverse effects.
    5. Chronic toxicity. There is no evidence of chronic toxicity from 
exposure to KDP. EPA in granting an exemption from the requirement of a 
tolerance for KDP when used as a fungicide, waived requirement of 
further testing to determine chronic toxicity because of low mammalian 
toxicity and no reports of adverse effects.
    6. Animal metabolism. KDP is a food grade material as established 
by the FDA under 21 CFR 182.1073. No adverse effects on animal 
metabolism have been reported in any of the animal studies reviewed.
    7. Metabolite toxicology. KDP is a food grade material as 
established by the FDA 21 CFR 182.1073. None of the metabolites of KDP 
are known or suspected to be toxic.
    8. Endocrine disruption. KDP does not belong to a class of 
chemicals known to have adverse effects on the endocrine system. No 
adverse effects were reported in any of the animal studies reviewed.

D. Aggregate Exposure

    1. Dietary exposure--i. Food. KDP is a food grade material as 
established by the FDA under 21 CFR 182.1073 and is identified as a 
GRAS chemical compound. KDP is exempt from the requirement of 
establishing a tolerance under 40 CFR 180.1193 and 180.1001(c) and (e). 
Use of KDP as an insecticide (use rates between 20 and 50 ppm) is 
unlikely to enhance consumer exposure given its ubiquitous nature and 
rapid biodegradability.
    ii. Drinking water. There is no expected human exposure to KDP in 
drinking water as most of it is absorbed when applied to plants.
    2. Non-dietary exposure. KDP is commonly found in many foods and 
consumer products and is a ubiquitous element in nature and, as a 
result, there are numerous routes of non-dietary exposure. In view of 
the small amount of KDP used in the pesticide formulation, its rapid 
absorption by plants and the rapid biodegradability of KDP, it is 
unlikely to influence non-dietary exposure to infants, children, or 
other consumer groups.

E. Cumulative Exposure

    The small amount of KDP used in the proposed pesticide formulation, 
its rapid absorption by plants and the rapid biodegradability of KDP, 
make it unlikely that KDP will influence the cumulative exposure to 
infants, children, or other consumer groups at the proposed use rates.

F. Safety Determination

    1.U.S. population. Given KDP's low-risk profile and the history of 
its safe use in pesticides and fertilizers, there is every reason to 
believe that no additional risk to the U.S. population will result from 
aggregate exposure to KDP.
    2. Infants and children. EPA, in granting an exemption from the 
requirement of a tolerance for KDP when used as a fungicide, has 
determined that in view of the lack of mammalian toxicity and the 
history of safe use there is no additional exposure or safety concerns 
for infants and children from the use of KDP as a pesticide.

G. Effects on the Immune and Endocrine Systems

    There are no reports of any adverse effects to immune or endocrine 
systems in animal studies or to human populations. There is reasonable 
certainty that no adverse effects will result from the use of KDP as an 
insecticide.

H. Existing Tolerances

    KDP is a food grade material as established by the FDA under 21 CFR 
182.1073. KDP is exempt from the requirement of a tolerance under 40 
CFR 180.1001(c) and (e) when used as an inert ingredient in pesticide 
formulations and under 40 CFR 180.1193 when used as a fungicide.

I. International Tolerances

    There are no Codex tolerances established for KDP.
[FR Doc. 04-3718 Filed 2-19-04; 8:45 am]
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