[Federal Register Volume 70, Number 80 (Wednesday, April 27, 2005)]
[Rules and Regulations]
[Pages 21641-21644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-8384]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0142; FRL-7710-9]


Trifluralin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
trifluralin in spearmint and peppermint oil under the Federal Food, 
Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality 
Protection Act of 1996 (FQPA). The FQPA substantially rewrote section 
408 of FFDCA. As a result, the revisions made it necessary, once again, 
to establish tolerances for mint oils that had previously been deemed 
unnecessary.

DATES: This regulation is effective April 27, 2005. Objections and 
requests for hearings must be received on or before June 27, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2004-0142. 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., 
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.

FOR FURTHER INFORMATION CONTACT: John W. Pates, Jr., Special Review and 
Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: 703-308-8195; 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), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    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

    In the Federal Register of November 24, 2004 (69 FR 68287) (FRL-
7686-4), EPA on its own initiative, under section 408(e) of FFDCA, 21 
U.S.C. 346a(e), announced a proposal to establish a permanent tolerance 
for residues of the herbicide trifluralin in spearmint and peppermint 
oil at 2.0 parts per million (ppm). The proposal included a summary of 
the exposure assessment prepared by the Agency. The Agency received 
three submissions for comment; two from private citizens and one from 
Dow AgroSciences, the registrant.

III. Response to Comments

    Comments received from the registrant address the following areas: 
evidence of errors and inconsistencies/miscalculations, belief that 
potential risks are significantly overstated, belief that unrealistic 
assumptions have been made, and the position that relevant information 
has been omitted and not incorporated into the Agency's decision(s). 
Additionally, the registrant has asked for clarification on labeling 
requirements. However, in general, the registrant does agree with the 
assessments that have been conducted for the human health and residue 
chemistry risk studies available for trifluralin. Furthermore, the 
registrant does not state any objections to the establishment of a 
permanent tolerance for residues of the herbicide trifluralin in 
peppermint and spearmint oil at 2.0 ppm.
    One of the private citizen's comments raised objections to any 
establishment of a tolerance for trifluralin. The citizen's comments 
and EPA's response to those comments follow:
    1. Comment. Both 28-day dermal and developmental toxicity tests on 
rabbits as well as a 1-year oral capsule study on dogs have no validity 
and are abusive to the test animals.
    EPA response. This commenter's objections to animal testing have 
been addressed in prior rulemaking documents. See 69 FR 63083, 63096 
(October 29, 2004).
    2. Comment. 1994 surveys of food intake are out of date.
    EPA response. Consumption survey data is used in part to determine 
acute and chronic exposure. In assessing exposure to trifluralin, EPA 
relied on food consumption data as reported by respondents in the 
United States Department of Agriculture (USDA) 1994-1996 and 1998 
Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). 
These surveys are generally updated every 10 years or so.

[[Page 21642]]

 The commenter claims the USDA surveys are out of date. The basis for 
this assertion is the commenter's observation that Americans are obese. 
This type of unsupported allegation is insufficient to call into 
question EPA's reliance on scientifically-designed studies. In any 
event, EPA's experience has been that while eating patterns change over 
time, these changes are generally marginal between surveys.
    3. Comment. The DEEM software is not suitable for evaluating 
exposure/risk
    EPA response. The commenter provides no basis for claiming that the 
DEEM is unsuitable for risk assessment. For this reason alone, the 
comment is insignificant. EPA would note, however, that the DEEM 
software has been thoroughly tested by the Agency and has been reviewed 
by an independent body of technical experts, the FIFRA Scientific 
Advisory Panel, and found to be suitable for evaluating risks of 
pesticide residues on food. The results of that review may be found at 
http://www.epa.gov/scipoly/sap/2000/february/partialfinalreport06292000.pdf.
    4. Comment. Exposure to residential handlers makes the product too 
dangerous to be sold.
    EPA response. The commenter states that if there are any exposures 
to residential handlers, then the product is far too dangerous to use 
or be sold. In response, EPA would first note that this tolerance 
rulemaking is being conducted under the FFDCA, and EPA does not 
regulate the sale or use of pesticides in residential settings under 
the FFDCA, although EPA does consider exposure from residential uses of 
pesticides in determining whether pesticide tolerances are safe. 
Decisions on whether a pesticide may be sold and distributed for 
residential uses is made pursuant to the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. Based on 
its uses, trifluralin has been assessed under the FFDCA for the 
residential applicator as well as other potential contact sources. 
Residential exposure scenarios were developed based on the use sites, 
formulations, application rates, and the various other equipment that 
could be used during applications. Residential risk estimates are also 
based on estimates (and assumptions) regarding the body weight of a 
typical homeowner/applicator, the area treated per application, and the 
seasonal duration (in days) of exposure. It is also assumed that 
residential applicators complete all elements of an application (mix/
load/apply) without use of protective equipment (assessments are based 
on an assumption that individuals will be wearing short-sleeved shirts 
and short pants). For short-term non-cancer risks to residential 
handlers, a margin of exposure (MOE) of less than 100 exceeds the 
Agency's level of concern. For residential handlers, calculations of 
short-term inhalation non-cancer risk indicate that the MOEs are 
greater than 100 for all residential handler scenarios. Likewise, 
residential handler cancer risk indicates that all scenarios are below 
the Agency's level of concern. Therefore, the Agency is confident that 
no unreasonable risk exists (excluding any misuse) based on the 
assumptions made, likely scenarios, and the conservative approach used 
in determining any potential risk problem for residential handlers.
    Another private citizen objected to allowing this genetically-
modified crop to become a legal use in the United States or anywhere 
else. The commenter argued that genetic modification of plants is an 
unknown danger to humans as well as a wide variety of other species. In 
response, EPA would note that the commenter is mistaken in concluding 
that the production of trifluralin involves genetic modification of 
plants.

IV. Conclusion

    Based on the information, analysis, and conclusions in the November 
24, 2004 (69 FR 68287) proposal, a tolerance is established for 
residues of trifluralin, alpha, alpha, alpha-trifluoro-2,6-dinitro-N,N-
dipropyl-p-toluidine, in or on spearmint and peppermint oil at 2.0 ppm.

V. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by 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 FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of 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 FFDCA, as was 
provided in the old sections 408 and 409 of 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 provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2004-0142 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 June 27, 
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 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 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 V.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-2004-0142, 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-

[[Page 21643]]

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).

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA on EPA's own initiaive. 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). Pursuant to the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), 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, 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 
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 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.

VII. 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: April 20, 2005.
Debra Edwards,
Director, Special Review and Reregistration 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 180.207 is amended by adding alphabetically entries for 
``peppermint oil,'' and ``spearmint oil'' to the table in paragraph 
(a). For the convenience of the reader the entire table to paragraph 
(a) is shown below.


Sec.  180.207  Trifluralin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Alfalfa, hay...............................................          0.2
Asparagus..................................................         0.05
Barley, hay................................................         0.05
Barley, straw..............................................         0.05
Bean, mung, sprouts........................................          2.0
Carrot, roots..............................................          1.0
Corn, field, forage........................................         0.05
Corn, field, grain.........................................         0.05
Corn, field, stover........................................         0.05

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Cotton, undelinted seed....................................         0.05
Cress, upland..............................................         0.05
Flax, seed.................................................         0.05
Fruit, citrus, group 10....................................         0.05
Fruit, stone, group 12.....................................         0.05
Grain, crop, except corn, sweet and rice grain.............         0.05
Grape......................................................         0.05
Hop........................................................         0.05
Legume, forage.............................................         0.05
Nut, tree, group 14........................................         0.05
Peanut.....................................................         0.05
Peppermint oil.............................................          2.0
Peppermint, tops...........................................         0.05
Rapeseed, seed.............................................         0.05
Safflower, seed............................................         0.05
Sorghum, forage............................................         0.05
Sorghum, grain, stover.....................................         0.05
Spearmint oil..............................................          2.0
Spearmint, tops............................................         0.05
Sugarcane, cane............................................         0.05
Sunflower, seed............................................         0.05
Vegetable, cucurbit, group 9...............................         0.05
Vegetable, fruiting, group 8...............................         0.05
Vegetables, leafy..........................................         0.05
Vegetables, root (exc. carrots)............................         0.05
Vegetables, seed and pod...................................         0.05
Wheat, grain...............................................         0.05
Wheat, straw...............................................         0.05
------------------------------------------------------------------------

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[FR Doc. 05-8384 Filed 4-26-05; 8:45 am]
BILLING CODE 6560-50-S