[Federal Register Volume 70, Number 153 (Wednesday, August 10, 2005)]
[Rules and Regulations]
[Pages 46428-46431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-15837]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0141; FRL-7728-1]


2-amino-4,5-dihydro-6-methyl-4-propyl-s-triazolo(1,5-
alpha)pyrimidin-5-one (PP796); Exemption from the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY:  This regulation amends the established exemption from the 
requirement of a tolerance under 40 CFR 180.1065 for 2-amino-4,5-
dihydro-6-methyl-4-propyl-s-triazolo(1,5-alpha)pyrimidin-5-one, which 
is also known as ``PP796'', by increasing the amount that can be used 
to not more than 0.3 percent in formulation of paraquat dichloride. 
Syngenta Crop Protection submitted a pesticide petition ((PP) 5E6929) 
requesting this amendment.

DATES: This regulation is effective August 10, 2005. Objections and 
requests for hearings must be received on or before October 11, 2005.

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 
identification (ID) number OPP-2005-0141. 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, 1801 S. Bell St., 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.

[[Page 46429]]


FOR FURTHER INFORMATION CONTACT: Karen Angulo, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 306-0404; 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 code 111)
     Animal production (NAICS code 112)
     Food manufacturing (NAICS code 311)
     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 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 at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In the Federal Register of June 30, 2005 (70 FR 37847) (FRL-7719-
4), EPA issued a notice pursuant to section 408(d)(3) of the Federal 
Food Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d)(3), announcing 
the filing of a pesticide tolerance petition (PP 5E6929) by Syngenta 
Crop Protection, P.O Box 18300, Greensboro, NC 27419-8300 for 2-amino-
4,5-dihydro-6-methyl-4-propyl-s-triazolo(1,5-alpha)pyrimidin-5-one, 
which is also known as ``PP796''. This notice included a summary of the 
petition prepared by the petitioner. The petition requested that the 
established exemption from the requirement of a tolerance under 40 CFR 
180.1065 be amended by increasing the amount of PP796 that can be used 
to not more than 0.3 percent in formulation of paraquat dichloride. No 
substantive comments were received in response to the notice of filing.
    Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(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. Pursuant to section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
section 408(b)(2)(C), which require EPA to give special consideration 
to exposure of infants and children to the pesticide chemical residue 
in establishing 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. . . .'' 
Additionally, section 408(b)(2)(D) of the FFDCA requires that the 
Agency consider ``available information concerning the cumulative 
effects of a particular pesticide's residues'' and ``other substances 
that have a common mechanism of toxicity.''
    The existing tolerance exemption under 40 CFR 180.1065 allows for 
the use of PP796 as an emetic at not more than 0.1 percent in 
formulation of paraquat dichloride. In the Federal Register Notice 
(November 12, 1981; 46 FR 55725) that established this exemption, EPA 
stated the following in its Basis for Approval: ``This exemption is 
justified because the severe health hazard associated with oral 
ingestion of paraquat allows for efforts to advance any opportunity to 
reduce retention of accidentally ingested paraquat formulations. Also, 
any possible adverse effect of PP796 (the inert emetic) is minimal in 
comparison to the irreversible severe consequences of paraquat 
ingestion. Based on the above information, and review of its use, it 
has been found that, when used in accordance with good agricultural 
practices, this ingredient is useful and does not pose a hazard to 
humans or to the environment.''
    According to EPA's Reregistration Eligibility Decision (RED; 1997) 
for paraquat dichloride, since 1988 the manufacturer of paraquat 
dichloride has added the emetic PP796 (a substance that induces 
vomiting), a stenching agent, and blue dye in an effort to prevent 
accidental and intentional ingestions from occurring. The RED stated 
that ``U.S. Poison Control Center data show a decline of almost 50 
percent when comparing the proportion of all pesticide exposures due to 
paraquat ingestion for the four years pre- and post 1988.''
    According to the RED, paraquat dichloride is a restricted use 
herbicide currently registered to control weeds and grasses in many 
agricultural and non-agricultural areas. The RED states there are no 
residential or other non-occupational uses of paraquat dichloride, and 
exposure to paraquat dichloride in drinking water is not expected. 
Therefore, exposure to PP796 from applications of paraquat dichloride 
are not expected from residential/non-occupational and drinking water 
sources. A substantial increase in dietary risk is not anticipated from 
this small raise of the allowable percentage of the emetic PP796 from 
0.1 to 0.3 in formulation of paraquat dichloride. Therefore, the Agency 
has determined that there is a reasonable certainty that no harm to any 
population subgroup will result from aggregate exposure when 
considering dietary exposure and all other non-occupational sources of 
pesticide exposure for which there is reliable information. Also, the 
health benefits of including an emetic in paraquat dichloride 
formulations as stated in the 1981 Federal Register Notice (46 FR 
55725) are reaffirmed here. In addition, the RED states paraquat 
dichloride does not pose a hazard to the environment. This small 
increase in the allowable amount of PP796 is also not expected to pose 
a hazard to the environment.

III. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the Food Quality 
Protection Act of 1996 (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

[[Page 46430]]

FFDCA by the FQPA of 1996, EPA will continue to use those procedures, 
with appropriate adjustments, until the necessary modifications can be 
made. The new section 408(g) 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), as 
was provided in the old FFDCA sections 408 and 409. 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 provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2005-0141 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 October 
11, 2005.
    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 issue(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 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th 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. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit III.A., 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-2005-0141, 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. 
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 issue(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 FFDCA section 408(d) in response to a petition 
submitted to the Agency. 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). Since 
tolerances and exemptions that are established on the basis of a 
petition under FFDCA section 408(d), such as the exemption in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. The Agency hereby certifies that this rule will not 
have significant negative 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, 
entitledFederalism(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 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 FFDCA section 408(n)(4). 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

[[Page 46431]]

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: August 1, 2005.

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.

0
2. Section 180.1065 is revised to read as follows:


Sec.  180.1065   2-Amino-4,5-dihydro-6-methyl-4-propyl-s-triazolo(1,5-
alpha)pyrimidin-5-one; exemption from the requirement of a tolerance.

    The inert ingredient, 2-amino-4,5-dihydro-6-methyl-4-propyl-s-
triazolo(1,5-alpha)pyrimidin-5-one is exempted from the requirement of 
a tolerance when used as an emetic at not more than 0.3 percent in 
formulations of paraquat dichloride. Further restrictions on this 
exemption are that this ingredient may not be advertised as an emetic 
and the paraquat product may not be promoted in any way because of the 
inclusion of this inert ingredient.

[FR Doc. 05-15837 Filed 8-9-05; 8:45 am]
BILLING CODE 6560-50-S