[Federal Register: June 1, 2005 (Volume 70, Number 104)]
[Notices]
[Page 31455-31459]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01jn05-70]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2005-0114; FRL-7711-8]
Hexythiazox; Notice of Filing a Pesticide Petition to Establish a
Tolerance for a Certain Pesticide Chemical in or on Food
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the initial filing of a pesticide
petition (PP) proposing the establishment of regulations for residues
of a certain pesticide chemical in or on various food commodities.
DATES: Comments, identified by docket identification (ID) number OPP-
2005-0114, must be received on or before July 1, 2005.
ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Bonaventure Akinlosotu, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 605-0653; e-mail address:
akinlosotu.bonaventure@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 111)
Animal production (NAICS 112)
Food manufacturing (NAICS 311)
Pesticide manufacturing (NAICS 32532)
[[Page 31456]]
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 ID number OPP-2005-0114. 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, 1801S. 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.
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/.
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.
Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
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. EPA intends to work towards
providing electronic access to all of the publicly available docket
materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
C. How and To Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA Dockets or e-mail to submit CBI or information
protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/
, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPP-2005-0114. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov,
Attention: Docket ID Number OPP-2005-0114. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address
[[Page 31457]]
identified in Unit I.C.2. These electronic submissions will be accepted
in WordPerfect or ASCII file format. Avoid the use of special
characters and any form of encryption.
2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2005-0114.
3. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID
Number OPP-2005-0114. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.
D. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes
any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed under FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in this
notice.
7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.
II. What Action is the Agency Taking?
EPA has received a pesticide petition as follows proposing the
establishment and/or amendment of regulations for residues of a certain
pesticide chemical in or on various food commodities under section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that this petition contains data or information
regarding the elements set forth in FFDCA section 408(d)(2); however,
EPA has not fully evaluated the sufficiency of the submitted data at
this time or whether the data support granting of the petition.
Additional data may be needed before EPA rules on the petition.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and record keeping
requirements.
Dated: May 23, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner summary of the pesticide petition is printed below
as required by FFDCA section 408(d)(3). The summary of the petition was
prepared by the petitioner and represents the view of the petitioner.
The petition summary announces the availability of a description of the
analytical methods available to EPA for the detection and measurement
of the pesticide chemical residues or an explanation of why no such
method is needed.
Gowan Company
PP 3F6569
EPA has received a pesticide petition (PP) 3F6569 from Gowan
Company, 370 S. Main Street, Yuma, AZ 85365 proposing, pursuant to
section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part
180 by establishing a tolerance for residues of hexythiazox: (trans-5-
(4-chlorophenyl)-N-cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide)
and its metabolites containing the (4-chlorophenyl)-4-methyl-2-
oxothiazolidine moiety expressed as parts per million (ppm) of the
parent compound in or on grapes at 1.0 ppm, raisins at 4.0 ppm, citrus
at 0.5 ppm, and citrus oil at 2.0 ppm.
EPA has determined that the petition contains data or information
regarding the elements set forth in section 408(d)(2) of the FFDCA;
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data supports granting of the
petition. Additional data may be needed before EPA rules on the
petition.
A. Residue Chemistry
1. Plant metabolism. The metabolism of hexythiazox as well as the
nature of the residues in plants is adequately understood for purposes
of this tolerance. Metabolism studies were conducted in four crops,
viz.; pears, grapes, oranges and apples. The major residue component is
unmetabolized parent. The metabolites are hydroxylcyclohexyl and
ketocyclohexyl analogs of hexythiazox and the amide formed by loss of
the cyclohexyl ring. Parent hexythiazox and its metabolites are
converted to a common moiety for residue analysis.
2. Analytical method. A practical analytical method, high pressure
liquid chromatography with an Ultraviolet (UV) detector, which detects
and measures residues of hexythiazox and its metabolites as a common
moiety, is available for enforcement purposes with a limit of detection
that allows monitoring of food with residues at or above the levels set
in this tolerance.
3. Magnitude of residues. Residue and processing studies on grapes
and citrus were conducted to support the proposed use. The number of
trials conducted is sufficient to satisfy requirements for national
registration for grapes and regional registration (CA, AZ, TX) for
citrus.
B. Toxicological Profile
1. Acute toxicity. A battery of acute toxicity studies places
technical grade hexythiazox in Toxicity Category IV for acute oral
lethal dose 50 ((LD50) > 5,000 milligram/
kilograms (mg/kg)), Category III for dermal LD50 > 5,000 mg/
kg), Category III for inhalation lethal concentration (LC50)
(LC50 > 2.0 mg/Liter(L)), Category III for primary eye
[[Page 31458]]
irritation (mild irritation, reddened conjunctiva), Category IV for
dermal irritation (non irritant). Hexythiazox is a non-sensitizer.
2. Genotoxicty. The following genotoxicity studies were all
negative: Ames gene mutation, CHO gene mutation, CHO chromosome
aberration, mouse micronucleus and rat hepatocyte unscheduled DNA
synthesis.
3. Reproductive and developmental toxicity. In a developmental
toxicity study in rats, the maternal No-Observed-Adverse-Effect-Level
(NOAEL) was 240 mg/kg/day and the maternal Lowest-Observed-Adverse-
Effect-Level (LOAEL) was 720 mg/kg/day based on increased ovarian
weights and decreased bone ossification.
In a developmental toxicity study in rabbits, the maternal NOAEL
was 1,080 mg/kg/day highest dose tested (HDT); the maternal LOAEL was
not determined. The developmental NOAEL was 1,080 mg/kg/day (HDT); the
developmental LOAEL was not determined. In a 2-generation reproduction
study in rats, the parental NOAEL was 35 mg/kg/day and the parental
LOAEL was 200 mg/kg/day based on decreased body weight gain, decreased
food consumption and efficiency, and increased liver, kidney and
ovarian weights. The reproductive NOAEL was 35 mg/kg/day and the
reproductive LOAEL was 200 mg/kg/day based on decreased pup body weight
(bwt) during lactation, delayed hair growth and eye opening.
4. Subchronic toxicity. In a 1-month feeding study in dogs, the
NOAEL was 1.75 mg/kg/day and the LOAEL was 12.5 mg/kg/day, based on
increased liver and adrenal weights.
5. Chronic toxicity. In a 1-year feeding study in dogs, the NOAEL
was 2.5 mg/kg/day and the LOAEL was 12.5 mg/kg/day, based on increased
alkaline phosphatase, increased adrenal and liver weights, and liver
and adrenal lesions. In a carcinogenicity study in mice, the NOAEL was
36 mg/kg/day and the LOAEL was 215 mg/kg/day. Effects were decreased
bwt in males and increased hepatocellular carcinomas and combined
adenoma/carcinomas.
In a chronic feeding/carcinogenicity study in rats, the NOAEL
(systemic) was 26 mg/kg/day and the LOAEL (systemic) was 180 mg/kg/day
based on decreased bwt gain and increased liver weights in both sexes.
The chronic reference dose (RfD) for hexythiazox is based on the 1-
year dog feeding study with a NOAEL of 2.5 mg/kg/day and an uncertainty
factor of 100. The Agency has classified hexythiazox as a category C
(possible human) carcinogen based on an increased incidence of
hepatocellular carcinomas (p = 0.028) and combined adenomas/carcinomas
(p = 0.024) in female mice at the highest dose tested (1,500 ppm) when
compared to the controls as well as a significantly increased (p
< 0.001) incidence of pre-neoplastic hepatic nodules in both males and
females at the HDT. The decision supporting a category C classification
was based primarily on the fact that only one species was affected and
mutagenicity studies were negative. In classifying hexythiazox as a
category C carcinogen, the Agency concluded that a quantitative
estimate of the carcinogenic potential for humans should be calculated
because of the increased incidence of liver tumors in the female mouse.
A Q1* of 0.022 mg/kg/day-\1\ in human equivalents was
published in the Federal Register of October 16, 1998 (63 FR 55540)
(FRL-6035-2).
6. Animal metabolism. The metabolism of hexythiazox has been
studied in goats, hens and rats. Metabolic pathways in the animal are
similar to those in plants.
7. Metabolite toxicology. There are no metabolites of toxicological
concern based on a differential metabolism between plants and animals.
8. Endocrine disruption. No specific tests have been conducted with
hexythiazox to determine whether the chemical may have an effect in
humans that is similar to an effect produced by a naturally occurring
estrogen or other endocrine effects. However, there were no significant
findings in other relevant toxicity tests, i.e., teratology and multi-
generation reproduction studies, which would suggest that hexythiazox
produces effects characteristic of the disruption of the estrogenic
hormone.
C. Aggregate Exposure
1. Dietary exposure from food. Tolerances have been established (40
CFR 180.479) for residues of hexythiazox (trans-5- (4-chlorophenyl)-N-
cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide) and its
metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-
thiazolidine moiety in or on apples at 0.50 ppm; wet apple pomace at
0.80 ppm; pears at 0.30 ppm; stone fruits (except plums) at 1.0 ppm;
plum, prune, fresh at 0.1 ppm; plum, prune, dried at 0.4 ppm;
strawberries at 3.0 ppm; nut tree group at 0.30 ppm; pistachio at 0.30
ppm; almond hulls at 10 ppm; caneberry crop group at 2.0 ppm; dates at
1.0 ppm; hops at 2.0 ppm; milk at 0.02 ppm; fat of cattle, goats,
horses, swine and sheep at 0.02 ppm; meat byproducts of cattle, goats,
horses, swine and sheep at 0.02 ppm; cotton, undelinted seed (CA only),
at 0.20 ppm; and cotton gin byproducts (CA only) at 3.0 ppm, and a
tolerance of 0.1 ppm for greenhouse tomatoes is pending. Additional
tolerances are being requested in this petition for grapes at 1.0 ppm,
raisins at 4 ppm, citrus (CA, AZ, TX) at 0.5 ppm, and citrus oil at 2.0
ppm.
EPA has estimated the following dietary exposures from hexythiazox
in food (Federal Register of September 29, 2000 (65 FR 58437) (FRL-
6746-5).
i. Acute exposure. For acute dietary exposure of the general
population including infants and children, a dose and endpoint
attributable to a single exposure were not identified by the Agency
from the available oral toxicity studies, including maternal toxicity
in the developmental toxicity studies. An acute RfD of 2.4 mg/kg/day
for females 13-50 years of age was identified from the rat
developmental toxicology study based on delayed ossification. A
conservative analysis was performed by the Agency using existing and
recommended tolerance level residues and 100% crop treated (CT)
information for all commodities. The acute dietary exposure estimate
for the females 13-50 years old subgroup was 0.002617 mg/kg/day at the
95th percentile. The registrant has concluded that hexythiazox use on
grapes and citrus will not significantly contribute to this dietary
exposure.
ii. Chronic exposure. A partially refined deterministic analysis
was performed by the Agency using anticipated residues (AR) levels for
most crops and %CT or anticipated market share information for all
crops. Dietary exposure estimates for the U.S. population and other
representative subgroups were < 0.00003 mg/kg/day. The registrant has
concluded that hexythiazox use on grapes and citrus will not
significantly contribute to this dietary exposure.
iii. Cancer. A partially refined deterministic carcinogenic risk
estimate analysis was performed by the Agency using AR levels and %CT
or anticipated market share information for all crops. The chronic
dietary exposure estimate for the U.S. population was 0.000011 mg/kg/
day. The registrant has concluded that hexythiazox use on grapes and
citrus will not significantly contribute to this dietary exposure.
2. Dietary exposure from drinking water. Using the Generic expected
environmental concentration (GENEEC) and Screening concentration in
ground water (SCI-GROW) models, the Agency has calculated the estimated
environmental concentrations (EECs) of hexythiazox to be 910.32
nanogram
[[Page 31459]]
(ng)/L for surface water and 1.47 ng/L for ground water. These
estimates are based on a maximum application rate of 0.1875 lbs. active
ingredient per acre.
3. From non-dietary exposure. The term ``residential exposure'' is
used by the Agency 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). Hexythiazox is not
registered for use on any sites that would result in residential
exposure.
D. Cumulative Exposure
EPA has not determined whether hexythiazox 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, hexythiazox does not share a toxic metabolite with other
substances. For the purposes of this tolerance action, therefore, the
registrant has not assumed that hexythiazox has a common mechanism of
toxicity with other substances. For purposes of this petition the
potential risks of hexythiazox in its aggregate exposure will only be
considered.
E. Safety Determination
1. U.S. population--i. Acute risk. Aggregate exposure risk includes
exposure from food and water. For acute dietary exposure of the general
population, a dose and endpoint attributable to a single exposure were
not identified by the Agency from the available oral toxicity studies.
For the relevant population subgroup of females 13+ years, the risk
from acute ``food only'' exposure is less than 1% of the RfD, which is
less than EPA's level of concern. The acute drinking water level of
comparison (DWLOC) calculated for the relevant population subgroup of
females 13+ years is 72,000 parts per billion (ppb). The calculated
DWLOC is significantly higher than the drinking water EECs for ground
water (0.0015 ppb) and surface water (0.910 ppb). EPA has concluded
with reasonable certainty that residues of hexythiazox in drinking
water do not contribute to the acute aggregate health risk.
ii. Short- and intermediate-term risk. Hexythiazox is not
registered for use on any sites that would result in residential
exposure. Therefore, the aggregate risk is the sum of the risk from
food and water, which do not exceed the Agency's level of concern.
iii. Chronic risk. Aggregate chronic risk (non cancer) exposure
from ``food only'' exposure utilizes less than 1% of the RfD for all
population subgroups. The chronic DWLOC for hexythiazox exposure in
drinking water is 870 ppb for the U.S. population and 250 ppb for
infants and children. The calculated DWLOCs are significantly higher
than the drinking water EECs for ground water (0.0015 ppb) and surface
water (0.910 ppb). EPA has concluded with reasonable certainty that
residues of hexythiazox in drinking water do not contribute to the
chronic (non cancer) aggregate health risk.
iv. Cancer risk. The carcinogenic risk estimate (food only) for the
general U.S. population <5 x 10-\7\. Thus, the carcinogenic
dietary risk associated with the existing and proposed uses of
hexythiazox does not exceed the level of concern for excess lifetime
cancer risk (1 x 10-\6\). The surface water and ground water
EECs were used to compare against back calculated the DWLOC for
aggregate risk assessments. For the carcinogenic risk scenario, EPA
calculated a DWLOC of 1.2 ppb for the U.S. population. The EECs ground
water and surface water (0.0015 ppb and 0.910 ppb, respectively) are
less than EPA's calculated DWLOC. Therefore, EPA concluded that
residues of hexythiazox in drinking water do not contribute
significantly to the carcinogenic aggregate human health risk.
2. Infants and children. For acute dietary exposure of infants and
children, a dose and endpoint attributable to a single exposure were
not identified by the Agency from the available oral toxicity studies.
The Agency has determined that the 10X-safety factor to protect infants
and children should be removed and reduced to 1X. It is concluded that
there is a reasonable certainty of no harm to infants and children from
aggregate exposure to hexythiazox residues.
F. International Tolerances
National maximum residue levels (MRL) for hexythiazox on grapes
have been established at 0.5 ppm in Germany, France, Italy, Spain,
Austria, and Hungry, and at 0.05 ppm in Switzerland. MRLs for
hexythiazox on citrus have been established at 2.0 ppm in Japan and
Korea, at 1.0 ppm in Spain, at 0.5 ppm in Italy, at 1.0 ppm for peel
and 0.01 ppm for pulp in Brazil, 0.2 ppm in France and 0.1 ppm in New
Zealand.
[FR Doc. 05-10843 Filed 5-31-05; 8:45 am]
BILLING CODE 6560-50-S