[Federal Register Volume 67, Number 44 (Wednesday, March 6, 2002)]
[Notices]
[Pages 10203-10205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-5316]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1073; FRL-6825-9]


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 control number PF-1073, must be 
received on or before April 5, 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 
control number PF-1073 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Treva Alston, Registration 
Division (7505W), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: 703.308-8373; 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 control number PF-1073. 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 control number PF-1073 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 (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 control number PF-1073. Electronic comments may 
also be filed online at many Federal Depository Libraries.

[[Page 10204]]

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 
control 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.

    Dated: February 21, 2002.
Peter Caulkins,
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.

ARCTECH, Inc.,

6E4705

    EPA has received a pesticide petition 6E4705 from 14100 Park Meadow 
Drive, Chantilly, VA 20151 proposing, pursuant to section 408(d) of the 
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to 
establish an exemption from the requirement of a tolerance for residues 
of humic acid, potassium salt when used as an inert ingredient in 
pesticide formulations applied to growing crops, raw agricultural 
commodities (RAC) after harvest, or to animals. 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. Product Identity

    1. Product chemistry. Humic substances are the naturally occurring 
brown or black organic multifunctional polymers with major agricultural 
and environmental roles. They are one of Earth's richest carbon 
reservoirs. They are considered a complex aromatic macromolecule with 
various linkages between the aromatic groups. The different compounds 
involved in linkages include amino acids, amino sugars, peptides, 
aliphatic acids and other aliphatic compounds. The various functional 
groups in humic substances include carboxylic groups (COOH), phenolic, 
aliphatic and enolic - OH and carbonyl (C=O) structures of various 
types.
    Humic acid (CAS No. 68131-04-4) is a hydrophilic, reversible 
colloid whose molecular weight ranges from 2,000 daltons for the more 
soluble form to 500,000 daltons for the less soluble form. The average 
molecular weight for humic acids is in the 20,000-50,000 daltons range.
    Chemically, humic acids are complex, polymeric polyhydroxy acids 
formed by the process of degradation of organic matter under the action 
of soil microorganisms and ground worms.
    Most humic acids of commercial use are produced by extraction of 
naturally occurring low rank coals with alkali. The potassium salt of 
humic acid is produced by extraction of Leonardite with potassium 
hydroxide.
    2. Proposed use practice. Humic acid, potassium salt is proposed 
for use as an inert ingredient in pesticide formulations that would 
typically be applied to growing crops. Humic acid, potassium salt has 
been used safely in commercial agriculture for many years, and is 
generally applied via tank mixing with fertilizers, and/or pesticides, 
or as granules. Humates such as humic acid, potassium salt are 
beneficial to growing plants, and are reported to affect germination 
speed, nutrient uptake, promote root and plant growth, and increase 
pesticide effectiveness. Use levels of humic acid, potassium salt are 
anticipated to be in the range of 5 to 50% by weight of the product 
formulation, with the typical use level expected to be in the 5 to 10% 
use range. It is anticipated that humic acid, potassium salt would be 
added directly to the pesticide active ingredient at the time of 
manufacture/formulation, or it would be tank-mixed with the pesticide 
at the time of application.
    3. Magnitude of residues. It is not expected that, when used as 
proposed, humic acid, potassium salt would result in residues that 
would remain in human food items.

B. Toxicological Profile

    1. Acute toxicity. Humic acid, potassium salt is ubiquitous in the 
environment, and is derived from soil or soil deposits. Potassium or 
sodium salts of humic acid are generally recognized as having low 
mammalian, aquatic and avian toxicity. Humic acid is less toxic 
compared to the conventional chelating

[[Page 10205]]

agents used in agriculture such as ethylenediaminetetraacetic acid 
(EDTA). The acute oral LD50 for humic acid is 5.5 gms/kg, 
for EDTA it is 2 gms/kg, thus humic acid is three times less toxic than 
EDTA. This poses no significant human health risks. Published 
literature reports that humic acid is nongenotoxic, nonteratogenic and 
nonmutagenic to test animals. There are no reports in the literature of 
humic acid, potassium salt causing disease or injury to man or other 
animals. No incidents of hypersensitivity have been reported in the 
published literature by researchers, manufacturers or users.
    2. Mutagenicity. Studies performed on A-MAX, a humic acid, 
potassium salt based material, indicate that humic acid is not 
mutagenic in S. typhimurim tester strains or in E.coli strain in either 
the presence or the absence of metabolic activation. The test results 
were also negative upon utilization of both the plate incorporation and 
pre-incubation methods.
    3. Genotoxicity. A study published on the in vivo cytogenic effects 
of natural humic acid determined that ``humic acid has not been 
demonstrated to be genotoxic either in vitro or in vivo.''
    4. Endocrine disruption. To date there is no evidence to suggest 
that humic acid, potassium salt functions in a manner similar to any 
known hormone, or that it acts as an endocrine disrupter.

C. Aggregate Exposure

    1. Dietary exposure. Dietary exposure from use of humic acid, 
potassium salt in pesticide formulations is minimal. Even if exposure 
occurred, the lack of reports of disease in man or animals indicates 
there is no risk for these exposures.
    i. Food. Dietary exposure from use of humic acid, potassium salt in 
pesticide formulations is minimal. Residues of humic acid, potassium 
salt are not expected on agricultural commodities. Humic substances are 
ubiquitous in nature and have been used for many years in commercial 
agriculture without adverse effect.
    ii. Drinking water. Humic substances are ubiquitous in nature, 
including soils, fresh water and oceans. Increased drinking water 
exposure from use of humic acid, potassium salt in pesticide 
formulations would not be expected. Humic acid, potassium salt has been 
widely used in commercial agriculture for many years without adverse 
effect.
    2. Non-dietary exposure. The potential for non-dietary exposure to 
the general population, including infants and children, is unlikely as 
the proposed use sites of pesticide formulations that would contain 
humic acid, potassium salt are commercial, agricultural and 
horticultural settings. However, non-dietary exposures would not be 
expected to pose any quantifiable risk due to a lack of residues of 
toxicological concern. In addition, the personal protective equipment 
required for use of most pesticide formulations mitigates the potential 
for exposure to applicators and handlers of the proposed products, when 
used in commercial, agricultural and horticultural settings.

D. Cumulative Effects

    Humate residues such as humic acid, potassium and sodium salts, 
when used as proposed, will not remain in human food items. As 
indicated previously in the acute toxicity section, the humic acid, 
potassium or sodium salts have shown a lack of toxicity to humans or 
other animal species, and there is no information in the literature 
indicating a cumulative effect with any other compound. A cumulative 
risk assessment is therefore, not necessary.

E. Safety Determination

    1. U.S. population. Humic substances are ubiquitous in the 
environment. Based on known acute toxicity studies, humic acid, 
potassium salt is not toxic to humans. There have been no reports of 
toxins or secondary metabolites associated with humic acid, potassium 
salt, and the acute toxicity studies conducted have shown that it is 
nontoxic and nonirritating to test animals. Published literature 
reports that humic acid is nongenotoxic, nonteratogenic and 
nonmutagenic to test animals. Residues of humic acid, potassium salt 
are not expected on agricultural commodities, and therefore, exposure 
to the general U.S. population, from the proposed uses, is not 
anticipated.
    2. Infants and children. Residues of humic acid, potassium salt, 
when used in pesticide formulations, are not expected on agricultural 
commodities. There is a reasonable certainty of no harm for infants and 
children from exposure to humic acid, potassium salt from the proposed 
use.

F. International Tolerances

    There are no international tolerances or tolerance exemptions for 
humic acid, potassium salt. No CODEX maximum residue levels have been 
established for humic acid, potassium salt.
[FR Doc. 02-5316 Filed 3-5-02; 8:45 am]
BILLING CODE 6560-50-S