Environmental Protection Agency (EPA).
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.
Comments, identified by docket control number PF-1073, must be received on or before April 5, 2002.
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.Start Further Info
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: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental 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:
|Categories||NAICS codes||Examples of potentially affected entities|
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@example.com, 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.Start Printed 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.Start List of Subjects
List of Subjects
- Environmental protection
- Agricultural commodities
- Feed additives
- Food additives
- Pesticides and pests
- Reporting and recordkeeping requirements
Dated: February 21, 2002.
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.
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 Start Printed Page 10205agents 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.End Supplemental Information
[FR Doc. 02-5316 Filed 3-5-02; 8:45 am]
BILLING CODE 6560-50-S