[Federal Register Volume 69, Number 189 (Thursday, September 30, 2004)]
[Rules and Regulations]
[Pages 58285-58290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21930]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0318; FRL-7680-8]


Dichlormid; Time-Limited Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of the inert ingredient (herbicide safener) dichlormid 
(Acetamide, 2,2-dichloro-N,N-di-2-propenyl-) in or on sweet corn 
commodities at 0.05 parts per million (ppm). Dow AgroSciences requested 
this tolerance under the Federal Food, Drug, and Cosmetic Act, (FFDCA) 
as amended by the Food Quality Protection Act of 1996 (FQPA). The 
tolerances will expire on December 31, 2005.

DATES: This regulation is effective September 30, 2004. Objections and 
requests for hearings must be received on or before November 29, 2004.

ADDRESSES:  To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. After submitting your original written objection or 
hearing request as instructed in Unit VI., you can use EDOCKET or 
regulations.gov to submit the requested copy (see also Unit VI.A.2.). 
EPA has established a docket for this action under Docket 
identification (ID) number OPP-2004-0318. 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: Kathryn Boyle, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: 703-305- 6304; 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:
     Industry (NAICS 111), e.g., Crop Production, e.g., 
agricultural workers; greenhouse, nursery, and floriculture workers; 
farmers.
     Industry (NAICS 112), e.g., Animal Production, e.g., 
cattle ranchers and farmers, dairy cattle farmers, livestock farmers.
     Industry (NAICS 311), e.g., Food Manufacturing, e.g., 
agricultural workers; farmers; greenhouse, nursery, and floriculture 
workers; ranchers; pesticide applicators.
     Industry (NAICS 32532), e.g., Pesticide Manufacturing, 
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/. 
To access the OPPTS Harmonized Guidelines referenced in this document, 
go directly to the guidelines athttp://www.epa.gpo/opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

    In the Federal Register of November 21, 2003 (68 FR 65708) (FRL-
7333-7), EPA issued a notice pursuant to section 408(d)(3) of the 
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
petition (PP 3E6676) by Dow AgroSciences LLC, 9330 Zionsville Rd., 
Indianapolis, IN 46268. This notice included a summary of the petition 
prepared by Dow AgroSciences, the petitioner.
    The petition requested that 40 CFR 180.469 be amended by 
establishing time-limited tolerances for residues of the herbicide 
safener dichlormid, (N,N-diallyl-2,2-dichloroacetamide or Acetamide, 
2,2-dichloro-N,N-di-2-propenyl-) (CAS Reg. No. 37764 -25-3), in or on 
sweet corn commodities at 0.05 parts per million (ppm). There were no 
comments received in response to the notice of filing.
    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....``
    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).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other

[[Page 58286]]

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 the FFDCA, for time-
limited tolerances for residues of dichlormid on sweet corn commodities 
at 0.05 ppm. EPA's assessment of exposures and risks associated with 
establishing the time-limited tolerances follows.

A. Toxicological Profile and Endpoints

    In 1999, the Agency prepared a risk assessment which was used as 
the basis for establishing time-limited tolerances for residues of 
dichlormid in or on field and pop corn commodities. A final rule for 
these time-limited tolerances published in the Federal Register of 
March 27, 2000 (65 FR 16143) (FRL-6498-7). Based on that risk 
assessment, EPA concluded at that time that all of the risks were below 
the Agency's level of concern and there was a reasonable certainty that 
no harm would result to the general population, and to infants and 
children from aggregate exposure to residues of dichlormid on corn 
commodities.
    No additional toxicity data has been reviewed and evaluated by the 
Agency since that time. For a complete description of the toxicological 
profile and endpoints, the uncertainty factors, the exposure assessment 
which included dietary exposure for both food and drinking water, the 
safety factor for infants and children, and aggregate risk for 
dichlormid, see the final rule of March 27, 2000.
    In response to the new petition, to establish time-limited 
tolerances for sweet corn commodities, the Agency has prepared a new 
assessment that evaluates the acute and chronic dietary and drinking 
water risks from exposure to dichlormid in or on field, pop and sweet 
corn commodities. The drinking water exposure estimates are the same as 
those in the March 27, 2000 Final Rule. Since, no other assessments or 
evaluations are needed for assessing the risk of dichlormid, only the 
acute and chronic scenarios are discussed in Unit III. below.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Time-limited 
tolerances (expiring December 31, 2005) are established in 40 CFR 
180.469 for residues of dichlormid, in or on field and pop corn 
commodities. Risk assessments were conducted by EPA to assess dietary 
exposures from dichlormid in or on field, pop and sweet corn 
commodities 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 one day 
or single exposure.
    In conducting the acute dietary risk assessment EPA used the 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCIDTM), 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 acute exposure assessments: 
The acute dietary risk analyses incorporated tolerance level residues 
and assumed 100% of the corn commodities were treated with dichlormid.
    ii. Chronic exposure. In conducting the chronic dietary risk 
assessment EPA used the DEEM-FCIDTM, which incorporates food 
consumption data as reported by respondents in the USDA 1994-1996 and 
1998 Nationwide CSFII, and accumulated exposure to the chemical for 
each commodity. The following assumptions were made for the chronic 
exposure assessments: The chronic dietary risk analyses incorporated 
tolerance level residues and assumed 100% of the corn commodities had 
been treated with dichlormid.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for dichlormid 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 dichlormid.
    For ground water, the Agency used its SCI-GROW (Screening 
Concentration in Ground Water) screening model and environmental fate 
data to determine the Estimated Environmental Concentration (EEC) of 
dichlormid in ground water. SCI-GROW is an empirical model based upon 
actual ground water monitoring data collected for the registration of a 
number of pesticides that serve as benchmarks for the model. The 
current version of SCI-GROW appears to provide realistic estimates of 
pesticide concentrations in shallow, highly vulnerable ground water 
sites (i.e., sites with sandy soils and depth to ground water of 10 to 
20 feet). The SCI-GROW ground water screening concentration is 0.046 
ppb.
    The Agency used the Generic Estimated Environmental Concentration 
(GENEEC) to estimate pesticide concentrations in surface water. GENEEC 
simulates a 1 hectare by 2 meter deep edge-of-the-field farm pond which 
receives pesticide runoff from a treated 10 hectare field. GENEEC can 
substantially overestimate true pesticide concentrations in drinking 
water. It has certain limitations and is not the ideal tool for use in 
drinking water risk assessments. However, it can be used in screening 
calculations and does provide an upper bound on the concentration of 
true drinking water concentrations.
    Using GENEEC and available environmental fate data, EPA calculated 
the following Tier 1 EECs for dichlormid:
     Peak (Acute) EEC: 27.29 ppb
     Average (Chronic) EEC 26.93 ppb
    Interim Agency policy allows the average (chronic) GENEEC value to 
be divided by 3 to obtain a value of 8.98 ppb for use in chronic risk 
assessment calculations.
    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 EECs from these models 
to quantify drinking water exposure and risk as a percent of reference 
dose (%RfD) or percent of population adjusted dose (%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 dichlormid they are further 
discussed in Unit III.D.
    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). Dichlormid is not 
approved for use on

[[Page 58287]]

any sites that would result in residential exposure.
    4. Cumulative Effects. 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 dichlormid. Dichlormid 
does not appear to produce a toxic metabolite produced by other 
substances. For the purposes of this action, therefore, EPA has not 
assumed that dichlormid 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 at http://www.epa.gov/pesticides/cumulative/.

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 database 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 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. Conclusion. The additional FQPA safety factor of 10X is retained 
for acute risks since: (1) There is qualitative evidence of increased 
susceptibility in the rabbit developmental study; and (2) the toxicity 
database is incomplete. There are data gaps for the 2-generation 
reproduction study in rats, and acute and subchronic neurotoxicity 
studies. The additional FQPA safety factor of 30X is applied for 
chronic risks for the reasons discussed above for acute risks and for 
the data gap for the chronic toxicity study in dogs.

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. 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 + 
residential 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. 
For dichlormid, a DWLOC was calculated for the acute and chronic 
scenarios for the U.S. population and for the most highly exposed 
population subgroup.
    When EECs for surface water and groundwater are less than the 
calculated DWLOCs, the Office of Pesticide Programs (OPP) concludes 
with reasonable certainty that exposures to the pesticide in drinking 
water (when considered along with other sources of exposure for which 
OPP has reliable data) would not result in unacceptable levels of 
aggregate human health risk at this time. Because OPP 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, OPP 
will reassess the potential impacts of residues of the pesticide in 
drinking water as a part of the aggregate risk assessment process.
    1. Acute risk. Using the exposure assumptions previously discussed 
for acute exposure, the acute dietary exposure from food to dichlormid 
will occupy 3% of the aPAD for the U.S. population, and 9% of the aPAD 
for non-nursing infants <1 year old. In addition, there is potential 
for acute dietary exposure to dichlormid in drinking water. Since the 
modeled groundwater and surface water concentrations are less than the 
DWLOCs, EPA does not expect the aggregate exposure to exceed 100% of 
the aPAD, as shown in the following Table 1:

                      Table 1.--Aggregate Risk Assessment for Acute Exposure to Dichlormid
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                                                                             Surface       Ground
              Population Subgroup                 aPAD /(mg/     %aPAD/     Water EEC    Water EEC   Acute DWLOC
                                                   kg/day)       (Food)       (ppb)        (ppb)        (ppb)
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U.S. Population                                         0.01            3        27.29           <1          338
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Non-nursing infants (<1 year old)                       0.01            9        27.29           <1           91
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions previously 
described for chronic exposure, EPA has concluded that exposure to 
dichlormid from food will utilize 5% of the cPAD for the U.S. 
population, and 11% of the cPAD for children 1-6 years old. In 
addition, there is potential for chronic dietary exposure to dichlormid 
drinking water. Since the modeled groundwater and surface water 
concentrations are less than the DWLOCs, EPA does not expect

[[Page 58288]]

the aggregate exposure to exceed 100% of the cPAD, as shown in the 
following Table 2:

               Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Dichlormid
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                                                                             Surface       Ground
              Population Subgroup                 cPAD /(mg/     %cPAD/     Water EEC    Water EEC     Chronic
                                                   kg/day)       (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                       0.0022            5         8.98           <1           73
------------------------------------------------
Children (1-6 years old)                              0.0022           11         8.98           <1           20
----------------------------------------------------------------------------------------------------------------

    3. Conclusion. 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 
residues of the herbicide safener dichlormid, (N,N-diallyl-2,2-
dichloroacetamide or Acetamide, 2,2-dichloro-N,N-di-2-propenyl-) (CAS 
Reg. No. 37764 -25-3).

IV. Other Considerations

A. Endocrine Disruptor Effects

    FQPA requires the Agency to develop a screening program to 
determine whether certain substances (including all pesticides and 
inerts or active ingredients) ``may have an effect in humans that is 
similar to an effect produced by a naturally occurring estrogen, or 
such other endocrine effect...'' The Agency has been working with 
interested stakeholders to develop a screening and testing program as 
well as a priority setting scheme. As the Agency proceeds with 
implementation of this program, further testing of products containing 
the inert ingredient dichlormid for endocrine effects may be required.

B. Analytical Enforcement Methodology

     Adequate enforcement methodology (gas chromatography with a 
nitrogen selective detector) is available to enforce the tolerance 
expression. The method may be requested from: Calvin Furlow, Public 
Information and Record Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 305-5229; e-mail address: 
[email protected].

C. International Residue Limits

    There is neither a Codex proposal, nor Canadian or Mexican limits 
for residues of dichlormid in corn commodities.

D. Conditions

    There are several data gaps which needed to be addressed before 
permanent tolerances can be established. The following studies have 
been submitted for Agency review and evaluation (1) 2-Generation 
Reproduction Study-Rat, (2) General Metabolism (3) Acute Neurotoxicity 
(4) Subchronic Neurotoxicity, (5) Crop Field Trials, and (6) Rotational 
Crop (Confined). The Agency will review and evaluate these studies, and 
then prepare a new risk assessment.
     The data gaps are not as extensive as it would seem. For the crop 
field trials, both pre-and post-emergent data using dichlormid have 
been provided. The additional field trials are to fulfill the guideline 
requirements. To account for the incomplete toxicological database, the 
Agency retained an additional 10X safety factor for infants and 
children as to acute risk and an additional 30X safety factor as to 
chronic risk.

V. Conclusion

    Therefore, time-limited tolerances expiring December 31, 2005, are 
established for residues of the herbicide safener dichlormid, (N,N-
diallyl-2,2-dichloroacetamide or Acetamide, 2,2-dichloro-N,N-di-2-
propenyl-) (CAS Reg. No. 37764-25-3) in or on sweet corn commodities at 
0.05 ppm.

VI. 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), 
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-2004-0318 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 November 
29, 2004.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 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 VI.A., you 
should also send a copy

[[Page 58289]]

of your request to the PIRIB for its inclusion in the official record 
that is described in ADDRESSES. Send us your copies, identified by 
docket ID number OPP-2004-0318, using one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov/. 
Follow the on-line instructions for submitting comments.
     Agency Website: http://www.epa.gov/edocket/. EDOCKET, 
EPA's electronic public docket and comment system, is EPA's preferred 
method for receiving electronic copies. Follow the on-line instructions 
for submitting materials to the docket.
     E-mail: [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.
     Mail: 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.
     Hand Delivery: In person or by courier, bring a copy to 
the location of the PIRIB described in ADDRESSES.
    Do not include any CBI in the copy you submit for the public 
docket.

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).

VII. Statutory and Executive Order Reviews

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

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 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: September 23, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

[[Page 58290]]

PART180-[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 180.469 is amended by revising the section heading, and the 
introductory text of paragraph (a), and by adding alphabetically new 
commodities to the table in paragraph (a) to read as follows:


Sec.  180.469  Dichlormid; tolerances for residues.

    (a) General. Tolerances are established for residues of dichormid; 
(Acetamide, 2,2-dichloro-N,N-di-2-propenyl-)(CAS Reg. No. 37764-25-3) 
when used as an inert ingredient (herbicide safener) in pesticide 
formulations in or on the following food commodities:

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    revocation
                                                  million        date
------------------------------------------------------------------------
                                * * * * *
Corn, sweet, forage                                    0.05     12/31/05
Corn, sweet, kernel plus cob with husks                0.05     12/31/05
 removed
Corn, sweet, stover                                    0.05     12/31/05
------------------------------------------------------------------------

* * * * *

[FR Doc. 04-21930 Filed 9-29-04; 8:45 am]
BILLING CODE6560-50-S