

[Federal Register: March 29, 2006 (Volume 71, Number 60)]
[Rules and Regulations]               
[Page 15612-15617]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29mr06-15]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2004-0328; FRL-7769-6]

 
Fenhexamid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
fenhexamid in or on ginseng and pear. The Interregional Research 
Project 4 (IR-4), Center for Minor Crop Pest Management requested this 
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective March 29, 2006. Objections and 
requests for hearings must be received on or before May 30, 2006.

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 EPA-HQ-OPP-2004-0328. All documents in the

[[Page 15613]]

docket are listed on the http://www.regulations.gov web site. (EDOCKET, EPA's 

electronic public docket and comment system was replaced on November 
25, 2005, by an enhanced Federal-wide electronic docket management and 
comment system located at http://www.regulations.gov/. Follow the on-

line instructions.) 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: Maria I. Rodriguez, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6710; e-mail 
address:rodriguez.maria@epa.gov.


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 underFOR 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 August 27, 2004 (69 FR 52684) (FRL-7675-
2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
3E6799) by The Interregional Research Project 4 (IR-4), Center for 
Minor Crop Pest Management, 681 U.S. Highway 1 South, North 
Brunswick, NJ 08902-3390. The petition requested that 40 CFR 180.553 be 
amended by establishing a tolerance for residues of the fungicide 
fenhexamid, in or on apple, wet pomace at 25 parts per million (ppm) 
and fruit, pome, group 11 at 10 ppm. That notice included a summary of 
the petition prepared by IR-4, the registrant. Comments were received 
from one individual in New Jersey opposing and objecting the 
establishment of tolerances for residues of fenhexamid. The individual 
criticized IR-4's involvement in the pesticide registration as well as 
EPA's way of conducting pesticide registration. EPA's response to the 
public comments received is in Unit IV. of this document. It should be 
noted that the petition for apple, wet pomace will be addressed at a 
later time in another ruling.
    In the Federal Register of November 30, 2005 (70 FR 71838)(FRL-
7735-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
4E6859 and PP 4E6860) by The Interregional Research Project 4 (IR-4), 
Center for Minor Crop Pest Management, 681 U.S. Highway 1 
South, North Brunswick, NJ 08902-3390. The petition requested that 40 
CFR 180.553 be amended by establishing a tolerance for residues of the 
fungicide fenhexamid, in or on cilantro (as part of crop subgroup 4A) 
at 30 ppm, ginseng at 0.3 ppm, non-bell pepper at 0.02 ppm, and 
pomegranate at 3.0 ppm. That notice included a summary of the petition 
prepared by IR-4, the registrant. It should be noted that the petition 
for cilantro, non-bell pepper, and pomegranate will be addressed at a 
later time in another ruling.
    Currently, there is an expired time-limited tolerance for 
fenhexamid in or on pears that is still listed in the CFR. As part of 
this final rule, EPA is taking the ministerial action of removing that 
expired tolerance.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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 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 FFDCA requires 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. . . 
.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.


III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of 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 FFDCA, for a tolerance for residues of fenhexamid in/on 
ginseng at 0.3 ppm and pear at 10 ppm. EPA's assessment of exposures 
and risks associated with establishing the tolerance follows.

[[Page 15614]]

A. 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. Specific information on the studies received and the nature 
of the toxic effects caused by fenhexamid as well as the no observed 
adverse effect level (NOAEL) and the lowest observed adverse effect 
level (LOAEL) from the toxicity studies can be found in the Federal 
Register of April 13, 2000 (65 FR 19842) (FRL-6553-7).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which no adverse effects are observed 
(the NOAEL) from the toxicology study identified as appropriate for use 
in risk assessment is used to estimate the toxicological level of 
concern (LOC). However, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) is sometimes used for risk 
assessment if no NOAEL was achieved in the toxicology study selected. 
An uncertainty factor (UF) is applied to reflect uncertainties inherent 
in the extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases.
    A summary of the toxicological endpoints for fenhexamid used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in theFederal Register of September 26, 2003 (68 FR 55513) 
(FRL-7326-7).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.553) for the residues of fenhexamid, in or on a 
variety of raw agricultural commodities. There are existing permanent 
tolerances (40 CFR 180.553(a)) for fenhexamid in/on almond, hull (2.0 
ppm), almond (0.02 ppm), bushberry subgroup 13B (5.0 ppm), caneberry 
subgroup 13A (20.0 ppm), cucumber (2.0 ppm), fruit, stone, group 12, 
except plum, prune, fresh, postharvest (10.0 ppm), grape (4.0 ppm), 
grape, raisin (6.0 ppm), juneberry (5.0 ppm), kiwifruit, postharvest 
(15.0 ppm), leafy greens, subgroups 4A, except spinach (30.0), 
lingonberry (5.0 ppm), pistachio (0.02 ppm), plum, prune, dried (2.5 
ppm), plum, prune, fresh (1.5 ppm), salal (5.0 ppm), strawberry (3.0 
ppm), vegetable, fruiting, group 8, except nonbell pepper (2.0 ppm). 
Risk assessments were conducted by EPA to assess dietary exposures from 
fenhexamid in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a one-day or single exposure.
    No such effects were identified in the toxicological studies for 
fenhexamid; therefore, a quantitative acute dietary exposure assessment 
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates 
food consumption data as reported by respondents in the USDA 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII), and accumulated exposure to the chemical for each commodity. 
The following assumptions were made for the chronic exposure 
assessments: Tolerance level residues, 100% crop treated (CT) and 
incorporating estimated exposure concentrations (EECs). Default 
processing factors were used for all commodities. This represents an 
unrefined conservative approach for quantifying risk. For chronic 
dietary risk, HED's level of concern is >100% chronic population 
adjusted dose (cPAD).
    iii. Cancer. EPA has classified fenhexamid as a ``not likely'' 
human carcinogen based on the lack of evidence of carcinogenicity in 
male and female rats as well as in male and female mice and on the lack 
of genotoxicity in an acceptable battery of mutagenicity studies. 
Therefore, a quantitative cancer dietary exposure assessment was not 
performed.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for fenhexamid in drinking water. 
Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of fenhexamid.
    Based on the FQPA Index Reservoir Screening Tool (FIRST), or the 
Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), and Screening Concentrations in Groundwater (SCI-GROW) models, 
the EECs of fenhexamid for acute exposures are estimated to be 29 parts 
per billion (ppb) for surface water and 0.0007 ppb for ground water. 
The EECs for chronic exposures are estimated to be 1.14 ppb for surface 
water and 0.0007 ppb for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Fenhexamid is not registered for use on any sites that would result 
in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, 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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to fenhexamid and any other 
substances and fenhexamid does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has not assumed that fenhexamid has a common 
mechanism of toxicity with other substances. For information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
the policy statements released by EPA's Office of Pesticide Programs 
concerning common mechanism determinations and procedures for 
cumulating effects from substances found to have a common mechanism on 
EPA's website athttp://www.epa.gov/pesticides/cumulative/.


D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an

[[Page 15615]]

additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. Fenhexamid is not acutely 
toxic, neurotoxic, carcinogenic or mutagenic and is not a developmental 
or reproductive toxicant. There is low concern for prenatal and/or 
postnatal toxicity resulting from exposure to fenhexamid. (See Federal 
Register of September 26, 2003 (68 FR 55513) (FRL-7326-7). In addition, 
there are no concerns for developmental neurotoxicity resulting from 
exposure to fenhexamid.
    3. Conclusion. Because there is a complete toxicity data base for 
fenhexamid, and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures, and there is low 
concern for prenatal or postnatal toxicity, the additional 10X safety 
factor has been removed. (See September 26, 2003).

E. Aggregate Risks and Determination of Safety

    1. Acute risk. An acute risk assessment was not performed. No 
toxicological endpoint attributable to a single (acute) dietary 
exposure was identified. Therefore, acute risk from exposure to 
fenhexamid is not expected.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
fenhexamid from food will utilize 10% of the cPAD for the U.S. 
population, 0.55% of the cPAD for all infants <  1 year old, and 68% of 
the cPAD for children 1-2 years old. There are no residential uses for 
fenhexamid that result in chronic residential exposure to fenhexamid. 
There is potential for chronic dietary exposure to fenhexamid in 
drinking water. After calculating DWLOCs and comparing them to the EECs 
for surface and ground water, EPA does not expect the aggregate 
exposure to exceed 100% of the cPAD, as shown in the following Table.

                    Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to fenhexamid
----------------------------------------------------------------------------------------------------------------
                                                                             Surface      Ground/
              Population/Subgroup                cPAD/mg/kg/    %/cPAD/     Water EEC/   Water EEC/    Chronic/
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                         0.17           10         1.14       0.0007        5,328
----------------------------------------------------------------------------------------------------------------
All Infants (< 1 year old)                               0.17           55         1.14       0.0007          839
----------------------------------------------------------------------------------------------------------------
Children (1-2 years)                                    0.17           68         1.14       0.0007          547
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Fenhexamid is not registered for use on any sites that would result 
in residential exposure. Therefore, the aggregate risk is the sum of 
the risk from food and water, which do not exceed the Agency's level of 
concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Fenhexamid is not registered for use on any sites that would result 
in residential exposure. Therefore, the aggregate risk is the sum of 
the risk from food and water, which do not exceed the Agency's level of 
concern.
    5. Aggregate cancer risk for U.S. population. The Agency has 
classified fenhexamid as a ``not likely'' human carcinogen based on 
lack of evidence of carcinogenicity in male and female rats as well as 
in male and female mice, and on the lack of genotoxicity in an 
acceptable battery of mutagenicity studies. Therefore, fenhexamid is 
not expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to fenhexamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (LC with MS detection or HPLC/ECD) 
is available to enforce the tolerance expression. The method may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.

B. International Residue Limits

    There is a Canadian maximum residue level (MRL) of 0.3 ppm for 
fenhexamid in/on ginseng. There are no Mexican, or Codex MRL's. As 
such, there are no issues regarding international harmonizaton.

C. Response to Public Comments Received Regarding Notice of Filing

    Comments were received from one individual in New Jersey opposing 
and objecting the establishment of tolerances for residues of 
fenhexamid. The individual criticized IR-4's involvement in the 
pesticide registration as well as EPA's way of conducting pesticide 
registration. The comments were in response to the notice of filing 
published in the Federal Register of August 27, 2004.
    One comment indicated that IR-4 and Rutgers University are 
profiteering by registering pesticides. The Interregional Research 
Project Number 4 (IR-4) Program was created by Congress in 1963 in 
order to assist minor crop growers in the process of obtaining 
pesticide registrations. IR-4 National Coordinating Headquarters is 
located at Rutgers University in NJ and receives the majority (90%) of 
its funding from the U.S. Department of Agriculture (USDA). It is the 
only publicly funded program that conducts research and

[[Page 15616]]

submits petitions for tolerances. IR-4 operates in collaboration with 
USDA, the Land Grant University System, the agrochemical industry, 
commodity associations, and the EPA. IR-4 identifies needs, prioritizes 
accordingly, and conducts research. The majority (over 80%) of IR-4's 
research is conducted on reduced-risk chemicals. Under the Pesticide 
Registration Improvement Act (PRIA), IR-4 works in cooperation with the 
registrant to request a waiver for the registration services. The 
waiver may be granted if the application is solely associated by 
simultaneous submission with a tolerance petition in connection with 
IR-4 and if it is in the public interest. This fee waiver serves as an 
incentive to pursue registration of minor uses supported by the IR-4 
Program. In addition to the work done in pesticide registration, IR-4 
develops risk mitigation measures for existing registered products. 
Therefore, IR-4 and Rutgers University are not profiteering from 
registering pesticides.
    An additional comment indicated that during animal testing, rabbits 
are abused, tortured, and fed toxic chemicals. The EPA Test Guidelines 
recommend rabbits as test animals in acute eye irritation studies as 
well as in longer term studies such as developmental toxicity and 
reproduction studies. Results obtained from studies conducted with 
animals (in general) are relevant to humans because cells and molecules 
of humans can be very similar to those of animals. Therefore, if a 
pesticide causes toxicity in animals, it is likely to do so in humans 
as well. The EPA supports the use of the least possible number of 
animals in the pertinent studies. In addition, it should be noted that 
currently there are no in vitro studies that can address the concerns 
these studies satisfy. The EPA is working with the Interagency 
Coordinating Committee on the Validation of Alternative Methods 
(ICCVAM) to investigate in vitro methods to determine the toxicological 
concerns associated with the use of pesticides.

V. Conclusion

    Therefore, the tolerances are established for residues of 
fenhexamid in or on ginseng at 0.3 ppm and pear at 10 ppm.

VI. 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 EPA-HQ-OPP-2004-0328 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 March 30, 
2006.
    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 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. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.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 EPA-HQ-OPP-2004-0328, to: Public 
Information and Records Integrity Branch, Information Technology and 
Resources Management 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. 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).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA 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

[[Page 15617]]

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 section 408(d) of FFDCA, such as the tolerance 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. 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.

VIII. 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 theFederal 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 
recordkeepingrequirements.

    Dated: March 20, 2006.
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 180.553(a) is amended by alphabetically adding entries for 
the commodities ``ginseng'' and ``pear'' to the table in paragraph (a); 
removing the text in paragraph (b); and reserving paragraph (b) with 
the paragraph heading to read as follows:


Sec.  180.553  Fenhexamid; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Ginseng..............................................                0.3
                                * * * * *
Pear.................................................                 10
                                * * * * *
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
* * * * *

[FR Doc. 06-2975 Filed 3-28-06; 8:45 am]

BILLING CODE 6560-50-S
