Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Humates,

[Federal Register: June 13, 2003 (Volume 68, Number 114)]

[Proposed Rules]

[Page 35349-35354]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr13jn03-31]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0182; FRL-7309-7]

Humates; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

SUMMARY: The Agency is proposing, on its on initiative, to amend the existing tolerance exemption for humic acid, sodium salt to include humic acid, potassium salt and humic acid. Such humate materials would be used as inert ingredients in pesticide formulations applied to growing crops under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: Comments, identified by docket ID number OPP-2003-0182, must be received on or before July 14, 2003.

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: Kerry Leifer, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-8811; fax number: (703) 305-0599; e-mail address: leifer.kerry@epa.gov. SUPPLEMENTARY INFORMATION:

1. General Information

   1. 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:

      [sbull] Crop producttion (NAICS code 111)

      [sbull] Animal production (NAICS code 112)

      [sbull] Food manufacturing (NAICS code 311)

      [sbull] Pesticide manufacturing (NAICS code 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.

   2. 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 identification (ID) number OPP-2003-0182. 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/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html , a beta site currently under development.

      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. Once in the system, select ``search,'' then key in the appropriate docket ID number.

      Certain types of information will not be placed in the EPA 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

      [[Page 35350]]

      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. 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.

   3. 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 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-2003-0182. 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 opp-docket@epa.gov, Attention: Docket ID Number OPP-2003-0182. 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-2003-0182.

      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-2003-0182. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I.A.1.

   4. 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.

   5. 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 any technical information and/or data you used that support your views.

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      4. If you estimate potential burden or costs, explain how you arrived at your estimate.

      5. Provide specific examples to illustrate your concerns.

      6. Offer alternatives.

      7. Make sure to submit your comments by the comment period deadline identified.

      8. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your response. It would also be helpful if you provided the name, date, and Federal Register citation related to your comments.

2. Background

   In the Federal Register of April 12, 2000 (65 FR 19759) (FRL-6498- 8), EPA issued a notice pursuant to section 408 for the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act (FQPA) (Public Law 104-170) announcing the filing of a pesticide petition (PP 6E4705) by LignoTech USA, Inc., 100 Highway 51 South, Rothschild, WI 54474-1198. This notice included a summary of the petition prepared by the petitioner LignoTech USA, Inc. This petition requested that 40 CFR 180.1001(c) and (e) be amended by establishing an exemption from the requirement of a tolerance for residues of humic acid, sodium salt. Subsequently, the petitioner revised the petition to request the establishment of an exemption from the requirement of a tolerance for residues of humic acid, sodium salt under 40 CFR 180.1001(c) only. There were no comments received in response to the Notice of Filing. In the Federal Register of July 18, 2000 (65 FR 44469) (FRL-6595-9), the Agency established an exemption from the requirement of a tolerance for residues of humic acid, sodium salt when used as an inert ingredient (adjuvant, UV protectant) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest.

   In the Federal Register of March 6, 2002 (67 FR 10203) (FRL-6825- 9), the Agency published a Notice of Filing to amend the above pesticide petition 6E4705 from Arctech, Inc. located at 14100 Park Meadow Drive, Chantilly, VA 20151, to amend the existing exemption from the requirement of a tolerance to include 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. The notice included a summary of the petition prepared by the petitioner, Arctech, Inc. There were no comments received in response to this Notice of Filing.

3. What Action is the Agency Taking?

   EPA on its own initiative, under section 408(e) of the FFDCA, 21 U.S.C. 346a, is proposing to establish an unlimited exemption from the requirement of a tolerance for residues of humic acid, sodium salt (CAS Reg. No. 68131-04-04); humic acid, potassium salt (CAS Reg. No. 68514- 28-3); and humic acid (CAS Reg. No. 1415-93-6) when used as an inert ingredient in pesticide formulations that are applied to growing crops under 40 CFR 180.1001(d).

   The Agency has not issued a final rule on the petition seeking the establishment of a tolerance exemption for humic acid, potassium salt, but rather is issuing this proposed rule to amend the existing tolerance exemption for humic acid, sodium salt to also include humic acid, potassium salt; and humic acid. Based on a review and evaluation of the available data, which includes a 90-day toxicity study using humic acid, the Agency believes that the tolerance exemption should also include humic acid, not just the two salts, as requested by the petitioners. The existing tolerance exemption for humic acid, sodium salt will also be shifted from 40 CFR 180.1001(c) to 40 CFR 180.1001(d). Given that the nature of the substances considered are naturally occurring materials, and ubiquitous in the environment, but essentially, a component of soil, the Agency believes that 40 CFR 180.1001(d), i.e., application to growing crops to be more appropriate. The Agency has determined that there are no existing products containing humic acid, sodium salt having post-harvest uses. Therefore, this action will not have an effect on any currently registered pesticide product.

   Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement of a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption from the requirement of a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .''

   Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for the establishment of an exemption from the requirement of a tolerance for humate materials. EPA's assessment of exposures and risks associated with establishing the exemption from the requirement of a tolerance follows.

4. Toxicological Profile

   EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by humate materials are discussed in this unit.

   Humate materials or humic substances occur naturally in the environment. They are part of the environment in which we grow our food. The use of the term humus is said to have occurred when Rome was an empire. The term has also been found in 18th century writings. Humic substances are used as soil conditioners to increase the amount of organic matter in the soil; thus, increasing the workability of the soil. They are widely regarded as being beneficial to plants.

   The formation of humic substances is not completely understood. It is known that humic substances arise during the decay of organic materials, which is the reason that humic substances are often associated with coal, lignite, and mudstones. There are several theories as to possible formation pathways (lignin theory, polyphenol theory, and sugar-amine condensation). Generally, humic substances can be further subdivided into three categories: humic acids, fulvic acids, and humins. Humic acid is the major extractable component. With humates being natural substances, there is some variation in composition of the various materials.

   There is some confusion as to an exact definition of humic acid. According to

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   various information, humic acids are colloids, that behave somewhat like clays. Humic acids are macromolecules that are soluble in dilute alkali. They vary from dark brown to black in color. They are amorphous, polymeric substances with molecular weights ranging from 5,000 to 50,000. The cation exchange capacity (the total amount of exchangeable cations a soil can retain) ranges from 200 to 500 milliequivalents per 100 grams of soil at pH 7. When the cation exchange sites are mostly hydrogen, then the material is referred to as humic acid. When the predominant cation is sodium, then the material is referred to as humic acid, sodium salt. Similarly, material would be referred to as humic acid, potassium salt if the predominant cation were potassium.

   1. Subchronic Toxicity

      The following subchronic toxicity data (National Technical Information Service (NTIS) PB92-164946) was located through an internet search using humic as search term. An abstract is located on the National Library of Medicine Specialized Information Services (NLM/ SIS). According to the abstract:

      Male and female Sprague-Dawley rats were administered drinking water containing humic acids either non-disinfected or following ozonation (O3) ozonation/chlorination (O32) for 90 consecutive days. Test animals drank either of two concentration of humic acids, 0.25 and 1.0 g/L total organic carbon (TOC), while controls received phosphate-buffered, distilled water. No consistent significant treatment-related effects were observed in body weight gain, organ weights, food or water consumption, or hematological and clinical chemistry parameters. No target organs were identified from the histopathological examination of the tissues. The most significant observation, an increase in liver to body weight ratio for the male animals in the 1.0 g/LO3/CL2 humic acid group, was not observed in any other group, nor was it corroborated via any biochemical measurements or histopathological analysis.

   2. Mutagenicity

      An abstract discussing the mutagenicity of two coal-derived humic substances (Sulcis and South Africa, Eniricerche, Italy) was located through the NLM/SIS. Their mutagenic activity on TA98 and TA100 Salmonella typhimurium strains, both in the presence or the absence of metabolic acitivation (S9) was discussed. Both compounds showed no effect on the two strains, as observed with natural humic acid.

5. Aggregate Exposures

   In examining aggregate exposure, FFDCA section 408 directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indooor uses).

   EPA establishes exemptions from the requirement of tolerances only in those cases where it can be demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonable foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of tolerance may be established.

   1. Dietary Exposure

      1. Food. Not only are humic substances abundant in nature, but they have been used in commercial agriculture for years to condition soils. Therefore, there is likely a substantial ongoing human dietary exposure to humate materials from these sources and increased dietary exposures from the use of humate materials as an inert ingredient in pesticide formulations is expected to be minimal.

      2. Drinking water exposure. Humic substances occur in abundance in nature, including soils, fresh water, and oceans. Increased drinking water exposure from the use of humate materials in pesticide formulations would not be expected.

   2. Other Non-Occupational Exposure

      Humic substances occur in abundance in nature, including soils that are in and around the home. The potential for an increase in the existing non-dietary exposure to the general population, including infants and children, is unlikely as these pestcide formulations containing humate materials would be used in agricultural and horticultural settings.

6. Cumulative Effects

   Section 408(b)(2)(v) of FFDCA requires that, when considering whether to establish, modify or revoke a tolerance or tolerance exemption, the Agency consider ``available information'' concerning the cumulative effects of particular chemical's residues and ``other substances that have a common mechanism of toxicity.'' The Agency has not made any conclusions as to whether or not humic acid, potassium salt shares a common mechanism of toxicity with other chemicals. However, humic acid, potasssium salt is expected to be practically non- toxic to mammals. Due to the expected lack of toxicity, a cumulative risk assessment is not necessary.

7. Determination of Safety for U.S. Population, Infants, and Children

   Humic substances are present in abundance in the soil and the environment. Humic substances have been used in commercial agriculture for years to condition soils. Based on available information on these chemically related substances, the Agency believes that humic acid; humic acid, postassium salt; and humic acid, sodium salt are practically non toxic to mammals. Due to the ubiquitous nature of these naturally occurring materials, and the high molecular weights of the humic materials, no chronic or acute effects are expected to occur. There is no available information to indicate that these naturally occurring substances are carcinogenic, mutagenic, or expected to have any effect on the immune or endocrine systems. Because of its abundance in nature and lack of toxicity, the Agency did not use the safety factor analysis in evaluating the risk posed by humate substances and did not apply an additional tenfold safety factor to protect infants and children.

   Based on the information in the preamble, EPA concludes that there is a reasonable certainty of no harm from aggregate exposure to residues of humic acid; humic acid, potassium salt; and humic acid, sodium salt. Accordingly, EPA finds that exempting these humate materials from the requirement of a tolerance will be safe.

9. Other Considerations

   1. Endocrine Disruptors

      FQPA requires EPA to develop a screening program to determine whether certain substances, including all pesticide chemicals (both inert and active ingredients), ``may have an effect in humans that is similar to an effect

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      produced by a naturally occuring estrogen, or such other endocrine effect....'' EPA has been working with interested stakeholders to develop a screening and testing program as well as a priority setting scheme. As the Agency proceeds with implementation of this program, further testing of products containing humic acid, potassium salt for endocrine effects may be required.

   2. Analytical Method(s)

      An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

   3. Existing Exemptions

      An exemption from the requirement of a tolerance does exist for humic acid, sodium salt (40 CFR 180.1001(c)) for use as an adjuvant, UV protectant.

   4. International Tolerances

      The Agency is not aware of any country requiring a tolerance for humic substances nor have any CODEX Maximum Residue Levels (MRLs) been established for any food crops at this time.

10. Conclusions

    Based on the information in this preamble, EPA concludes that there is a reasonable certainty of no harm from aggregate exposure to residues of humic acid; humic acid, potassium salt; and humic acid, sodium salt. Accordingly, EPA finds that exempting humate materials from the requirement of a tolerance will be safe.

11. Statutory and Executive Order Reviews

    This proposed rule establishes a consolidated and expanded exemption from the requirement for a tolerance under section 408(d) of the FFDCA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this proposed rule has been exempted from review under Executive Order 12866 due to its lack of significance, this proposed rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This proposed rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental organizations. After considering the economic impacts of today's proposed rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. Establishing an exemption from the requirement of a pesticide tolerance (or, expanding and consolidating a tolerance exemption, as is proposed today), is in effect, the removal of a regulatory restriction on pesticide residues in food and thus such an action will not have any negative economic impact on any entities, including small entities. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure ``meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' ``Policies that have federalism implications'' is defined in the Executive order to include regulations that have ``substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This proposed rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this proposed rule does not have any ``tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure ``meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' ``Policies that have tribal implications'' is defined in the Executive Order to include regulations that have ``substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This proposed rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this proposed rule.

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    List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

    Dated: June 4, 2003. Peter Caulkins, Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR chapter I be amended as follows:

    PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as follows:

       Authority: 21 U.S.C. 321(q), 346(a) and 371.

    2. Section 180.1001 is amended as follows:

       i. The table to paragraph (c) is amended by removing the entry for ``humic acid, sodium salt.''

       ii. The table in paragraph (d) is amended by adding alphabetically three inert ingredients to read as follows:

       Sec. 180.1001 Exemptions from the requirement of a tolerance.

       * * * * *

       (d) * * *

       Inert ingredients

       Limits

       Uses

       * * * * * * * Humic Acid, CAS Reg. No. 1415-93 .................. Adjuvant, UV Protectant Humic Acid, Potassium salt CAS .................. Adjuvant, UV Reg. No. 68514-28-3.

       Protectant Humic Acid, Sodium Salt CAS Reg. .................. Adjuvant, UV No. 68131-04-4.

       Protectant * * * * * * *

       [FR Doc. 03-14881 Filed 6-12-03; 8:45 am]

       BILLING CODE 6560-50-S