[Federal Register Volume 68, Number 131 (Wednesday, July 9, 2003)]
[Rules and Regulations]
[Pages 40803-40808]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17106]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0134; FRL-7303-6]


Diallyl Sulfides; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of diallyl sulfides (DADs) in/on garlic, 
leeks, onions, and shallots. Platte Chemical Company submitted a 
petition to EPA under section 408(d)(1)(B) of the Federal Food, Drug, 
and Cosmetic Act (FFDCA), requesting an exemption from the requirement 
of a tolerance. This regulation eliminates the need to establish a 
maximum permissible level for residues of DADs in/on garlic, leeks, 
onions, and shallots.

DATES: This regulation is effective July 9, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0134, 
must be received on or before September 8, 2003.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, electronically, or in person. Please follow the detailed 
instructions for each method as provided in Unit IX. of the 
SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: By mail: Driss Benmhend, c/o Product 
Manager (PM) 90, Biopesticides and Pollution Prevention Division 
(7511C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-9525; e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (NAICS 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
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-2003-0134. 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 
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 http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180 --00.html, a 
beta site currently under development. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://

[[Page 40804]]

www.epa.gov/opptsfrs/home/guidelin.htm.
    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

    In the Federal Register of November 21, 2001 (66 FR 58481) (FRL-
6802-2), 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 
tolerance petition (PP 1F6316) by Platte Chemical Company, 419 18th 
Street, Greeley, CO 80632. As required by section 408(d)(2)(A)(i)(I), 
this notice included a summary of the petition prepared by the 
petitioner Platte Chemical Company. There were no comments received in 
response to the notice of filing.
    The petition requested that 40 CFR part 180 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of diallyl sulfides.

III. Risk Assessment

    New section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) 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) 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. . . .'' Additionally, section 408(b)(2)(D) requires that the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

IV. Toxicological Profile

    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 and considered its validity, completeness, and reliability 
and the relationship of this information 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.
    DADs are a composition of diallyl sulfides that includes diallyl 
monosulfide, diallyl disulfide, diallyl trisulfide, and diallyl 
pentasulfide. They are naturally occurring compounds found in Allium 
crops, including onion and garlic and are partially responsible for the 
distinctive odor of garlic. The end-use product, Alli-Up is proposed 
for use as a soil fumigant solution for the control of white rot 
(Sclerotium cepivorum) in garlic, leeks, onions, and shallots. It 
contains 90% of DADs in a liquid formulation (8.3 lbs of active 
ingredient per gallon). Application is recommended for any field that 
shows evidence or has a history of white rot infestations. When applied 
to infected soils in conjunction with a rotational crop, DADs will 
mimic the presence of an Allium crop, which will in turn stimulate the 
germination of white rot spores (sclerotia). The germinated spores will 
subsequently perish since no host crop is present. The product is 
applied through conventional soil fumigation equipment such as an 
enclosed shanking system.
    Toxicity studies submitted in support of the tolerance exemption 
petition, and the Agency reviews are compiled in the public docket 
established for this action under the docket ID number OPP-2003-0134.
    1. Acute oral toxicity (OPPTS Harmonized Guideline 870.1100; 152-
10; Master Record Identification Number (MRID) 45422907). Five male and 
5 female rats were dosed with 200, 600, and 1,000 milligram/kilogram 
(mg/kg) and 10 of each were dosed with 5,000 mg/kg. The acute oral LD 
50 was determined at 346 mg/kg. Treated rats displayed a 
number of abnormalities including breathing abnormalities, wobbly gait, 
decreased defecation, decreased activity, and pilo-erection. The 
abnormalities are attributed to hemolytic anemia as it is experienced 
by rodents when feeding on materials rich on sulfur and derived from 
onion and garlic.
    2. Acute dermal toxicity (OPPTS Harmonized Guideline 870.1200; 152-
11; MRID 45422908). Five male and 5 female rats were dosed with 1,500, 
1,750, and 2,000 mg/kg, observed daily and weighed weekly. The acute 
dermal LD50 of DADs in male rats was determined to be 1,826 
mg/kg, in female 2,009 mg/kg, and in sexes combined 1,967 mg/kg, or a 
Toxicity Category II.
    3. Primary eye irritation (OPPTS Harmonized Guideline 870.2400; 
152-13; MRID 45422909). Six rabbits were administered DADs in the right 
eye with the left eye serving as an untreated control. Exposure of the 
test article produced corneal opacity in 3/6 test eyes at the 1 or 24-
hour scoring interval. Conjunctivitis was noted in 6/6 test eyes at the 
1-hour testing interval. The conjunctival irritation resolved 
completely in all animals by study day 14. Under the conditions of the 
test, DADs are considered a moderate eye irritant, and Toxicity 
Category III for eye irritation.
    4. Primary dermal irritation (OPPTS Harmonized Guideline 870.2500; 
152-14; MRID 45422910). These compound are Toxicity Category II for 
dermal irritation. Severe skin reactions of the rabbits exposed, with 
evident erythema grade 2 and 1 at 1 hour post-exposure were observed.
    5. Dermal sensitization (OPPTS Harmonized Guideline 870.2600; 152-
15; MRID 45422911). A dermal sensitization potential test for DADs was 
evaluated using guinea pigs. DADs were found to be contact dermal 
sensitizers in guinea pigs, in accordance with the Buehler test.
    6. Mutagenicity (OPPTS Harmonized Guideline 870.5195; MRID 
45422912). A Salmonella/mammalian-microsome reverse mutation assay 
(Ames Test) was done using DADs. The assay evaluated the test article 
for its ability to induce reverse mutations at the histidine locus in 
the genome of specific Salmonella typhimurium tester strains in both 
the presence and absence of an exogenous metabolic activation system of 
mammalian microsomal enzymes derived from ArocolrTM induced 
rat liver. The results of the assay indicate that under the conditions 
of the study, DADs did not cause a positive increase in the number of 
histidine revertants per

[[Page 40805]]

plate of any of the tester strains either in the presence or absence of 
the microsomal enzymes prepared from the ArocolrTM induced 
rat liver (S9). As a result, Diallyl disulfide, the main component of 
DADs, are not considered mutagenics.
Data Waivers were requested for the following studies:
     Acute inhalation toxicity (OPPTS Harmonized Guideline 870.1300; 
152-12).
     Mammalian mutagenicity tests (OPPTS Harmonized Guideline 870.5195) 
except for an Ames test.
     90-Day feeding (1 species) (OPPTS Harmonized Guideline 870.3100).
     90-Day dermal (1 species) (OPPTS Harmonized Guideline 870.3250).
     90-Day inhalation (1 species) (OPPTS Harmonized Guideline 
870.3465).
     Teratogenicity (1 species) (OPPTS Harmonized Guideline 870.3700).
     Chronic exposure (OPPTS Harmonized Guideline 870.4100) (Tier III)
     Oncogenicity (OPPTS Harmonized Guideline 870.4200) (Tier III)
    DADs are naturally present in garlic and other Allium crops and in 
fields planted with these crops. In spite of the long history of garlic 
consumption and exposure to DADs by humans, no immunotoxic effects, 
such as induced dysfunction or inappropriate suppressive or stimulatory 
responses in components of the immune system of humans or test animals 
have been reported and are not expected from the exposure to DADs. As a 
result, the waiver requests listed above were approved.

V. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures, including 
drinking water from ground water or surface water and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).

A. Dietary Exposure

    The product Alli-Up containing DADs is intended for agricultural 
use as a soil fumigant for the purpose of suppression of onion white 
rot (Sclerotia cepivorum). The presence of DADs in the soil will 
stimulate the pathogen to become active and seek out its host, an 
Allium sp., which is not present. The pathogen will then perish. DADs 
in the soil are then subject to microbial breakdown and adsorption to 
soil particles. By the time the soil is prepared and ready for a new 
crop, most DADs have already dissipated. As a result, when new crops 
are planted, the likelihood of DADs residue present in the mature crop 
is considered low.
    1. Food. From food and feed uses. As explained above, the presence 
of DADs residue in food is unlikely. Moreover, the primary source for 
human exposure to DADs would occur through the consumption of garlic, 
other Allium crops or garlic derived products. There have been no 
reports of adverse reactions to humans resulting from the consumption 
of Allium crops and derived products. The over-all toxicology profile 
of DADs suggests that the risk associated with acute exposures by the 
oral route would be low.
    2. Drinking water exposure. Since Alli-Up will only be used as a 
soil fumigant, there is little if any, potential for drinking water 
exposure from pesticide drift in the surface water. Moreover, DADs in 
the soil are then subject to microbial breakdown and adsorption to soil 
particles and dissipation in the air. Therefore, the level of residues 
that might get into the ground water or surface water would most likely 
be negligible.

B. Other Non-Occupational Exposure

    The potential for non-dietary exposure to DADs for the general 
population is unlikely because potential use sites are commercial 
agricultural. Since the material is shanked into the treated soil 
during commercial applications, any odor present would be similar to 
that of a commercial garlic field or to that arising from freshly cut 
or pressed garlic as found in a typical household kitchen. EPA is 
unaware of any reports of adverse reactions to humans resulting from 
Allium crops and derived products odor or consumption.

VI. 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.''
    EPA does not have, at this time, available data to determine 
whether DADs have 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, DADs do not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has not assumed that 
DADs have 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).

VII. 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 MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. Based on the lack of 
observed developmental toxicity, EPA has concluded there is reasonable 
certainty that no harm to infants, children, or adults will result from 
aggregate exposure to DADs residues. Exemption of DADs from the 
requirements of a tolerance should pose no significant risk to humans 
or the environment.
    3. Conclusion. There is reasonable certainty that no harm will 
result from aggregate exposure to residues of diallyl sulfides to the 
U.S. population. This includes all anticipated dietary exposures and 
all other exposures for which there is reliable information. The Agency 
has arrived at this conclusion based on the low levels of toxicity, the 
long history of safe consumption of garlic and onions which naturally 
contain diallyl sulfides, and the lack of exposure. Levels of exposure 
resulting from use of diallyl sulfides would be significantly lower 
than those found in the U.S. population's consumption of onion and 
garlic foods (raw, cooked and processed). Moreover, the Agency 
concludes that diallyl sulfides is non-toxic to humans, including 
infants and children. Thus, there is no threshold effects of concern 
and, as a result the provision requiring an additional margin of safety 
does not apply. Further, the provisions of consumption patterns,

[[Page 40806]]

special susceptibility, and cumulative effects do not apply. As a 
result, EPA has not used a margin of exposure (safety) approach to 
assess the safety of diallyl sulfides.

VIII. Determination of Safety

    Based on the preceding 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 DAD 
residues.

IX. Other Considerations

A. Endocrine Disruptors

    EPA is required under section 408 of the FFDCA to develop a 
screening program to determine whether certain substances (including 
all pesticide active and other ingredients) ``may have an effect in 
humans that is similar to an effect produced by a naturally occurring 
estrogen, or other such endocrine effects as the Administrator may 
designate.'' Following the recommendations of its Endocrine Disruptor 
Screening and Testing Advisory Committee (EDSTAC), EPA determined that 
there is no scientific basis for including, as part of the program, the 
androgen and thyroid hormone systems in addition to the estrogen 
hormone system. EPA also adopted EDSTAC's recommendation that the 
program include evaluations of potential effects in wildlife. For 
pesticide chemicals, EPA will use FIFRA and, to the extent that effects 
in wildlife may help determine whether a substance may have an effect 
in humans, FFDCA authority to require wildlife evaluations. As the 
science develops and resources allow, screening of additional hormone 
systems may be added to the Endocrine Disruptor Screening Program 
(EDSP). When the appropriate screening and/or testing protocols being 
considered under the Agency's Endocrine Disruptor Screening Program 
have been developed, DADs may be subjected to additional screening and/
or testing to better characterize effects related to endocrine 
disruption.
    Based on available data, no endocrine system-related effects have 
been identified with consumption of DADs. In addition, DADs do not 
share any structural similarity to any known endocrine disruptive 
chemical.

B. Analytical Method

    EPA is establishing an exemption from the requirement of a 
tolerance for the reasons stated above. Because a tolerance exemption 
does not establish numerical limit for the amount of the pesticide 
chemical residues that may be present, and for the reasons stated above 
that led the Agency to conclude that a tolerance exemption was 
warranted, the Agency has concluded that an analytical method is not 
necessary for enforcement purposes for DADs.

C. Codex Maximum Residue Level

    No Codex maximum residue levels are established for residues of 
DADs in or on any food or feed crop. There are no established 
tolerances or exemptions from tolerance for DADs in the United States. 
The Agency has classified DADs as a biochemical pesticide.

X. Conclusions

    Based on the toxicology data submitted, there is reasonable 
certainty no harm will result from aggregate exposure of residues of 
DADs to the U.S. population, including infants and children, This 
includes all anticipated dietary exposures and all other exposures for 
which reliable data were submitted, accepted and reviewed. The Agency 
has no reports of adverse reactions of humans resulting from Allium 
crops and derived products' odor or consumption. As a result, EPA 
establishes an exemption from tolerance requirements pursuant to FFDCA 
section 408(c) and (d) for residues of DADs in or on garlic, leeks, 
onions, and shallots.

XI. 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 of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need To Do To File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2003-0134 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 September 
8, 2003.
    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.

[[Page 40807]]

    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 IX.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.2. Mail your 
copies, identified by docket ID number OPP-2003-0134, 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.2. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

XII. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance 
requirement 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 exemption in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. 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.

XIII. 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.


[[Page 40808]]


    Dated: June 13, 2003.
James Jones,
Director, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

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2. Section 180.1228 is added to subpart D to read as follows:


Sec.  180.1228  Diallyl sulfides; exemption from the requirement of a 
tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of diallyl sulfides when used in/on garlic, leeks, onions, and 
shallots.

[FR Doc. 03-17106 Filed 7-8-03; 8:45 am]
BILLING CODE 6560-50-S