[Federal Register Volume 69, Number 62 (Wednesday, March 31, 2004)]
[Rules and Regulations]
[Pages 16800-16806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-6932]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0052; FRL-7349-3]


Zoxamide; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of zoxamide in or on ginseng. This action is in response to 
EPA's granting of an emergency exemption under section 18 of the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing 
use of the pesticide on ginseng. This regulation establishes a maximum 
permissible level for residues of zoxamide in this food commodity. The 
tolerance will expire and is revoked on December 31, 2006.

DATES: This regulation is effective March 31, 2004. Objections and 
requests for hearings, identified by docket ID number OPP-2004-0052, 
must be received on or before June 1, 2004.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT:  Barbara Madden, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6463; 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 Get Copies of This Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2004-0052. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document

[[Page 16801]]

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://ecfr.gpoaccess.gov/ecfr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing a tolerance for residues of the fungicide 
zoxamide (3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-
methylbenzamide), in or on ginseng at 0.06 parts per million (ppm). 
This tolerance will expire and is revoked on December 31, 2006. EPA 
will publish a document in the Federal Register to remove the revoked 
tolerance from the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18-related tolerances to set binding precedents for the 
application of section 408 of the FFDCA and the new safety standard to 
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA 
to establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    Section 408(b)(2)(A)(i) of the 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 the FFDCA defines ``safe'' to mean that ``there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing 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. . . 
.''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or 
State agency from any provision of FIFRA, if EPA determines that 
``emergency conditions exist which require such exemption.'' This 
provision was not amended by the Food Quality Protection Act of 1996 
(FQPA). EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.

III. Emergency Exemption for Zoxamide on Ginseng and FFDCA Tolerances

    Leaf and stem blight are diseases caused by pathogens for 
Alternaria and Phytophthora. If left unchecked, their damage to growing 
ginseng is seen in root rot, premature defoliation, and loss in root 
yields (ginseng is a root crop). Total yield loss is likely. The 
ginseng industry maintains that the alternative pesticide and cultural 
control means are insufficient. Although there are, in fact, pesticides 
that are labeled for these problems on ginseng, the alternatives are 
not effective or have a resistance issue in regards to the pathogens. 
Azoxystrobin was also labeled under section 3 for ginseng in 2000, 
however, its use is limited to six treatments per season, in order to 
preserve its efficacy. EPA has authorized under FIFRA section 18 the 
use of zoxamide on ginseng for control of Alternaria and Phytophthora 
in Michigan and Wisconsin. After having reviewed the submission, EPA 
concurs that emergency conditions exist for these States.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of zoxamide in or on ginseng. 
In doing so, EPA considered the safety standard in section 408(b)(2) of 
the FFDCA, and EPA decided that the necessary tolerance under section 
408(l)(6) of the FFDCA would be consistent with the safety standard and 
with FIFRA section 18. Consistent with the need to move quickly on the 
emergency exemption in order to address an urgent non-routine situation 
and to ensure that the resulting food is safe and lawful, EPA is 
issuing this tolerance without notice and opportunity for public 
comment as provided in section 408(l)(6) of the FFDCA. Although this 
tolerance will expire and is revoked on December 31, 2006, under 
section 408(l)(5) of the FFDCA, residues of the pesticide not in excess 
of the amounts specified in the tolerance remaining in or on ginseng 
after that date will not be unlawful, provided the pesticide is applied 
in a manner that was lawful under FIFRA, and the residues do not exceed 
a level that was authorized by this tolerance at the time of that 
application. EPA will take action to revoke this tolerance earlier if 
any experience with, scientific data on, or other relevant information 
on this pesticide indicate that the residues are not safe.
    Because this tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether zoxamide meets 
EPA's registration requirements for use on ginseng or whether a 
permanent tolerance for this use would be appropriate. Under these 
circumstances, EPA does not believe that this tolerance serves as a 
basis for registration of zoxamide by a State for special local needs 
under FIFRA section 24(c). Nor does this tolerance serve as the basis 
for any State other than Michigan and Wisconsin to use this pesticide 
on this crop under section 18 of FIFRA without following all provisions 
of EPA's regulations implementing FIFRA section 18 as identified in 40 
CFR part 166. For additional information regarding the emergency 
exemption for zoxamide, contact the Agency's Registration Division at 
the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    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 the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action. EPA has sufficient data to assess the hazards of 
zoxamide and to make a determination on aggregate exposure,

[[Page 16802]]

consistent with section 408(b)(2) of the FFDCA, for a time-limited 
tolerance for residues of zoxamide in or on ginseng at 0.06 ppm. EPA's 
assessment of the dietary exposures and risks associated with 
establishing the tolerance follows.

A. Toxicological Endpoints

    Tolerances have been established for residues of zoxamide in or on 
grapes, potatoes, tomatoes and the cucurbit vegetable group 9 (40 CFR 
180.567). 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. A summary of the toxicological dose and endpoints for 
zoxamide for use in human risk assessment is discussed in Unit III.A. 
of the Federal Register of April 11, 2001 (66 FR 18725) (FRL-6774-8).
    Briefly, an endpoint for acute dietary exposures was not identified 
since no effects were observed in oral toxicity studies that could be 
attributable to a single dose. For chronic dietary exposures, the 
chronic reference dose (cRfD) is 0.48 milligrams/kilogram/day (mg/kg/
day). The FQPA safety factor was removed (i.e., reduced to 1x) for 
zoxamide, because there is no indication of quantitative or qualitative 
increased susceptibility of rats or rabbits to in utero and/or 
postnatal exposure; a developmental neurotoxicity study conducted with 
zoxamide is not required. Therefore, the chronic population adjusted 
dose (cPAD) is 0.48 mg/kg/day. Short-term and intermediate-term 
aggregate exposure takes into account residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Zoxamide is not registered for use on any sites that would 
result in residential exposure. Therefore, short-term and intermediate-
term aggregate risks were not assessed. Zoxamide has been classified as 
not likely to be carcinogenic to humans. Therefore, the only exposure 
scenario the Agency assessed is for chronic (non-cancer) exposures to 
zoxamide.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.567) for the combined residues of zoxamide and 
its metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid (RH-1455 and 
RH-141455) and 3,5-dichloro-4-hydroxymethylbenzoic acid (RH-1452 and 
RH-141452) in or on potatoes, tomatoes and the cucurbit vegetable group 
9 and for only residues of zoxamide on grapes. Risk assessments were 
conducted by EPA to assess dietary exposures from zoxamide in food as 
follows:
    i. Acute exposure. Acute dietary 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 1-day or 
single exposure. No acute dietary endpoint was identified since no 
effects were observed in oral toxicity studies that could be 
attributable to a single dose. Therefore, acute dietary risk 
assessments were not performed.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment, the Dietary Exposure Evaluation Model software with the 
Food Commodity Intake Database (DEEM-FCIDT, Version 1.3) analysis 
evaluated the individual food consumption 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: Published and proposed tolerances level residues 
were used. Default processing factors and 100% crop treated were 
assumed for all commodities.
    iii. Cancer. Zoxamide has been classified as not likely to be 
carcinogenic to humans. Therefore, risk assessments to estimate risk 
from cancer were 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 zoxamide 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 zoxamide.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
screening concentration in ground water (SCI-GROW), which predicts 
pesticide concentrations in ground water. In general, EPA will use 
GENEEC (a Tier I model) before using PRZM/EXAMS (a Tier II model) for a 
screening-level assessment for surface water. The GENEEC model is a 
subset of the PRZM/EXAMS model that uses a specific high-end runoff 
scenario for pesticides. GENEEC incorporates a farm pond scenario, 
while PRZM/EXAMS incorporate an index reservoir environment in place of 
the previous pond scenario. The PRZM/EXAMS model includes a percent 
crop area factor as an adjustment to account for the maximum percent 
crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead drinking 
water levels of comparison (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. Since 
DWLOCs address total aggregate exposure to zoxamide, they are further 
discussed in the aggregate risk sections below.
    Based on the PRZM/EXAMS and SCI-GROW models, the EECs of zoxamide 
for chronic exposures are estimated to be 21.8 parts per billion (ppb) 
for surface water and 2.1 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). Zoxamide is not 
registered for use on any sites that would result in residential 
exposure.
    4. Cumulative exposure to 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.''

[[Page 16803]]

    EPA does not have, at this time, available data to determine 
whether zoxamide has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
zoxamide 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 zoxamide 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 final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

C. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an 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 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 margin of exposure 
(MOE) analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans.
    2. Conclusion. There is a complete toxicity data base for zoxamide 
and exposure data are complete or are estimated based on data that 
reasonably accounts for potential exposures. EPA determined that the 
10x safety factor to protect infants and children should be removed. 
The FQPA factor is removed because:
    i. There is no indication of quantitative or qualitative increased 
susceptibility of rats or rabbits to in utero and/or postnatal 
exposure;
    ii. A developmental neurotoxicity study conducted with zoxamide is 
not required;
    iii. The dietary (food and drinking water) exposure assessments 
will not underestimate the potential exposures for infants and 
children. Additionally, there are currently no residential uses.

D. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water (e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + chronic non-dietary, non-occupational 
exposure)). This allowable exposure through drinking water is used to 
calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to zoxamide in drinking water (when considered along with 
other sources of exposure for which EPA has reliable data) would not 
result in unacceptable levels of aggregate human health risk at this 
time. Because EPA considers the aggregate risk resulting from multiple 
exposure pathways associated with a pesticide's uses, levels of 
comparison in drinking water may vary as those uses change. If new uses 
are added in the future, EPA will reassess the potential impacts of 
zoxamide on drinking water as a part of the aggregate risk assessment 
process.
    1. Acute risk. No acute dietary endpoint was identified since no 
effects were observed in oral toxicity studies that could be 
attributable to a single dose. Therefore, acute dietary risk 
assessments were not performed.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to zoxamide 
from food will utilize 1% of the cPAD for the U.S. population, 1% of 
the cPAD for all infants (<1 year old), and 4% of the cPAD for children 
1-2 years old, the subpopulation at greatest exposure. There are no 
residential uses for zoxamide. In addition, despite the potential for 
chronic dietary exposure to zoxamide in drinking water, after 
calculating DWLOCs and comparing them to conservative model EECs of 
zoxamide in surface water and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the cPAD, as shown in Table 1 of 
this unit:

                Table 1.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Zoxamide
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                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     %cPAD      Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
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U.S. population                                         0.48           1%         21.8          2.1       16,600
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All Infants (<1 year old)                               0.48           1%         21.8          2.1        4,600
--------------------------------------------------------------
Children (1-6 years old)                                0.48           4%         21.8          2.1        4,600
----------------------------------------------------------------------------------------------------------------

    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). Zoxamide 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 were previously addressed.

[[Page 16804]]

    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account non-dietary, non-occupational exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Zoxamide 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 were previously addressed.
    5. Aggregate cancer risk for U.S. population. Zoxamide has been 
classified as not likely to be carcinogenic to humans. Therefore, risk 
assessments to estimate risk from cancer were not performed.
    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 zoxamide residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (e.g., gas chromotography) 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: [email protected].

B. International Residue Limits

    There are currently no established Codex, Canadian, or Mexican 
maximum residue limits (MRLs) for residues of zoxamide in/on ginseng. 
Therefore, no compatibility issues exist with regard to the proposed 
U.S. ginseng time-limited tolerance.

VI. Conclusion

    Therefore, the tolerance is established for residues of zoxamide 
(3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-
methylbenzamide), in or on ginseng at 0.06 ppm.

VII. 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 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 provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2004-0052 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 1, 
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 (1900C), 
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 Rm. 104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. 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 
(703) 603-0061.
    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 VII.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.1. Mail your 
copies, identified by the docket ID number OPP-2004-0052, 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 Unit I.B.1. 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

[[Page 16805]]

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).

VIII. Statutory and Executive Order Reviews

    This final rule establishes a time-limited tolerance under section 
408 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). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 exemption under section 408 of the 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 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.

IX. 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: March 19, 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.

0
2. Section 180.567 is amended by adding text to paragraph (b) to read 
as follows:


Sec.  180.567  Zoxamide.

* * * * *
    (b) Section 18 emergency exemptions. A time-limited tolerance is 
established for residues of the fungicide zoxamide (3,5-dichloro-N-(3-
chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide) in connection 
with use of the pesticide under a section 18 emergency exemption 
granted by EPA. The tolerance will expire and is revoked on the date 
specified in the following table.

------------------------------------------------------------------------
             Commodity              Parts per million   Revocation date
------------------------------------------------------------------------
Ginseng                                          0.06           12/31/06
------------------------------------------------------------------------


[[Page 16806]]

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[FR Doc. 04-6932 Filed 3-30-04; 8:45 am]
BILLING CODE 6560-50-S