[Federal Register Volume 69, Number 115 (Wednesday, June 16, 2004)]
[Rules and Regulations]
[Pages 33576-33578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-12913]



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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0166; FRL-7361-6]


Humates; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes three exemptions from the 
requirement of a tolerance for residues of humic acid (CAS No. 1415-93-
6); humic acid, sodium salt (CAS No. 68131-04-4); and humic acid, 
potassium salt (CAS No. 68514-28-3) when used as inert ingredients in a 
formulated pesticide product. The Agency is acting on its own 
initiative, under section 408(e) of the Federal Food, Drug, and 
Cosmetic Act (FFDCA), 21 U.S.C. 346a establishing these tolerance 
exemptions. This regulation eliminates the need to establish a maximum 
permissible level for residues of humic acid; humic acid, sodium salt; 
and humic acid, potassium salt.

DATES: This regulation is effective June 16, 2004. Objections and 
requests for hearings must be received on or before August 16, 2004.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit III. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
ID number OPP-2004-0166. All documents in the docket are listed in the 
EDOCKET index at http://www.epa.gov/edocket. Although listed in the 
index, some information is not publicly available, i.e., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available either electronically in EDOCKET or in hard copy 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.

FOR FURTHER INFORMATION CONTACT: Bipin Gandhi, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8380; 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:
     Crop production (NAICS 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     Pesticide manufacturing (NAICS 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 Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), 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 on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In the Federal Register of June 13, 2003 (68 FR 35349) (FRL-7309-
7), EPA issued a proposed rule under section 408(e) of the FFDCA, 21 
U.S.C. 346a, as amended by the Food Quality Protection Act (FQPA) 
(Public Law 104-170). The Agency proposed to establish exemptions from 
the requirement of a tolerance for residues of humic acid (CAS No. 
1415-93-6); humic acid, sodium salt (CAS No. 68131-04-4); and humic 
acid, potassium salt (CAS No. 68514-28-3) in 40 CFR 180.1001(d).
    No comments were received via EPA's electronic public docket. 
However, a staff member of the Washington State Department of 
Agricultural sent a comment directly to the Agency's contact via email. 
The staff member asked why the exemptions for the humate materials were 
being created under 40 CFR 180.1001(d) instead of 40 CFR 180.950. The 
commenter indicated his belief that an exemption under 40 CFR 180.950 
would be a more logical choice for humate materials.
    In response to this comment, the Agency's Lower Risk Pesticide 
Chemical Focus Group evaluated humic acid, and its sodium and potassium 
salts to determine the appropriateness of a List 4A classification for 
these materials. Given that humate materials are naturally occurring 
materials, and essentially a component of dirt, classification as List 
4A is consistent with previous List classifications on other 
``weathered'' materials. Tolerance exemptions for List 4A materials 
such as humic acid (CAS No. 1415-93-6); humic acid, sodium salt (CAS 
No. 68131-04-4); and humic acid, potassium salt (CAS No. 68514-28-3) 
are established in 40 CFR 180.950.
    Based on the reasons set forth in the preamble to the proposed 
rule, and considering the comment received by the Agency in response to 
the proposed rule, EPA is establishing three new tolerance exemptions 
for humic acid (CAS No. 1415-93-6); humic acid, sodium salt (CAS No. 
68131-04-4); and humic acid, potassium salt (CAS No. 68514-28-3).

III. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of the FFDCA, as was provided in the old FFDCA sections 408 and 409 of 
the FFDCA. However, the period for filing objections is now 60 days, 
rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions

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provided in this unit and in 40 CFR part 178. To ensure proper receipt 
by EPA, you must identify docket ID number OPP-2004-0166 in the subject 
line on the first page of your submission. All requests must be in 
writing, and must be mailed or delivered to the Hearing Clerk on or 
before August 16, 2004.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential 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. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 2046-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit III., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2004-0166, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

IV. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance 
requirement 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 rule has been exempted from 
review under Executive Order 12866 due to its lack of significance, 
this 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 final 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). Because this 
action will not have an adverse impact on small business, I certify, 
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), that this 
action will not have a significant economic impact on a substantial 
number of 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 final rule directly regulates growers, food

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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 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 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 rule.

V. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

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 2, 2004
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

Sec.  180.910  [Amended]

0
2. In Sec.  180.910, the table is amended by removing the entry for 
humic acid, sodium salt.
0
3. In Sec.  180.950, the table in paragraph (e) is amended by adding 
alphabetically the following inert ingredients:


Sec.  180.950  Tolerance exemptions for minimal risk active and inert 
ingredients.

* * * * *
    (e) * * *

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                 Chemical                              CAS No.
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                                * * * * *
Humic acid................................  1413-93-6
Humic acid, potassium salt................  68514-28-3
Humic acid, sodium salt...................  68131-04-4
                                * * * * *
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[FR Doc. 04-12913 Filed 6-15-04; 8:45 am]
BILLING CODE 6560-50-S