[Federal Register Volume 68, Number 114 (Friday, June 13, 2003)]
[Proposed Rules]
[Pages 35349-35354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14881]


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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.

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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: 
[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:
    [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.

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 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.

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 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 [email protected], 
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.

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 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.

II. 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.

III. 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.

IV. 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.

A. 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.

B. 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.

V. 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.

A. 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.

B. 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.

VI. 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.

VII. 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.

IX. Other Considerations

A. 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

[[Page 35353]]

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.

B. 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.

C. 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.

D. 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.

X. 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.

XI. 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.

[[Page 35354]]

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
                              * * * * * * *
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[FR Doc. 03-14881 Filed 6-12-03; 8:45 am]
BILLING CODE 6560-50-S