Notice of Filing a Pesticide Petition to Establish a Tolerance
for a Certain Pesticide Chemical in or on Food
[Federal Register: March 6, 2002 (Volume 67, Number 44)]
[Notices]
[Page 10203-10205]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06mr02-56]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: alston.treva@epa.gov.
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: opp-docket@epa.gov, 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