[Federal Register Volume 59, Number 77 (Thursday, April 21, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9297]
[[Page Unknown]]
[Federal Register: April 21, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 81
[Air Docket No. A-90-42; FRL-4876-2]
Designations of Areas for Air Quality Planning Purposes;
Amendments and Corrections
AGENCY: Environmental Protection Agency.
ACTION: Final rule.
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SUMMARY: The Environmental Protection Agency (EPA) is reaffirming its
January 15, 1992 decision to exclude Northern Orange County from the
New York-New Jersey-Long Island Consolidated Metropolitan Statistical
Area (NYCMSA) ozone nonattainment area in the State of New York.
However, EPA has determined that Northern Orange County should be
linked with Poughkeepsie ozone nonattainment area. This action is based
on information that was brought to EPA's attention by comments on EPA's
rulemaking actions which established the current designations and
classifications of these areas. EPA is also reaffirming its decision to
exclude Putnam County from the NYCMSA ozone nonattainment area and
include Putnam County in the Poughkeepsie ozone nonattainment area in
the State of New York. This rule completes a process begun on December
28, 1990 to determine the appropriate boundaries of the NYCMSA ozone
nonattainment area.
EFFECTIVE DATE: This final rule is effective on April 21, 1994.
ADDRESSES: Materials relevant to this rulemaking are included in Air
Docket A-90-42, located in Rm. M-1500, First Floor, Waterside Mall, 401
M Street SW., Washington, DC, and may be inspected at this location
during the hours from 8:30 a.m. to 12 noon and from 1:30 p.m. to 3:30
p.m., Monday through Friday, except for legal holidays. A duplicate
copy of the docket is located in the EPA Regional Office listed below.
FOR FURTHER INFORMATION CONTACT: William S. Baker, Chief, Air Programs
Branch, Environmental Protection Agency, Region II, 26 Federal Plaza,
room 1034A, New York, New York 10278, (212) 264-2517.
SUPPLEMENTARY INFORMATION: In the Federal Register (FR) of November 6,
1991 (56 FR 56694), EPA issued a final rule promulgating or announcing
the designations, boundaries, and classifications of virtually all
ozone and carbon monoxide nonattainment areas (including the NYCMSA and
the Poughkeepsie ozone nonattainment areas), all particulate matter
(PM10) nonattainment areas, and some lead nonattainment areas.
Under the authority of sections 107 (d)(2)(B) and (d)(5), 172(a)(1)(B),
and 181(a)(3), 186(a)(2), and 188(a) of the amended Clean Air Act (the
Act), EPA was not required to solicit public comment prior to these
promulgations and, in view of the tight time frames imposed under the
Act for designations, classifications, and State Implementation Plan
(SIP) submittals, EPA determined that a formal public comment period
prior to the promulgations would not be appropriate. Therefore, in its
November 6, 1991 notice, EPA stated it would entertain only those
public comments addressing the technical correctness of its
determinations and significant new policy issues.
In the November 6, 1991 notice, EPA determined that the entire
NYCMSA should be designated as nonattainment for ozone, with a
classification of severe-17, except in regards to the designation of
Orange and Putnam Counties. EPA deferred making a determination at that
time for Orange and Putnam Counties, pending a request from the State
of New York to conduct a study of the boundaries of the nonattainment
area. EPA also determined in its November 6, 1991 notice that the
Poughkeepsie ozone nonattainment area, made up of Dutchess County,
should be designated marginal nonattainment for ozone.
In the Federal Register of November 30, 1992 (57 FR 56762), EPA
issued a final rule containing amendments in response to comments
received on its November 6, 1991 notice. Among other things, in the
November 30, 1992 notice, EPA determined that:
(1) The existing severe-17 classification of the NYCMSA area shall
remain unchanged and would include in Orange County, New York the towns
of Blooming Grove, Chester, Highlands, Monroe, Tuxedo, Warwick, and
Woodbury;
(2) The remaining towns in Orange County would be excluded from the
NYCMSA and designated attainment, specifically the Towns of Cornwall,
Crawford, Deerpark, Goshen, Greenville, Hamptonburgh, Middletown,
Minisink, Montgomery, Mount Hope, Newburgh, New Windsor, Port Jervis,
Wallkill, Wawayanda and the City of Newburgh; and,
(3) Putnam County, New York will be grouped together with Dutchess
County, New York and be part of the Poughkeepsie ozone nonattainment
area, and be designated as marginal.
For the reasons discussed in its November 30, 1992 notice, EPA
solicited comments on the technical correctness of its determination to
exclude the northern portion of Orange County and Putnam County from
the NYCMSA. EPA stated it would continue to coordinate its analysis of
previous comments and any new comments with the State of New York. In
addition, EPA stated that, following the comment period on its November
30, 1992 rule, it would come to closure on the boundaries issue in
consultation with the State of New York, and would provide the
appropriate notification of its decision.
This Federal Register provides such notification that EPA has come
to closure on the boundaries issue for the NYCMSA. By this rule, EPA is
reaffirming its decision to exclude Putnam and Northern Orange Counties
from the NYCMSA ozone nonattainment area, but rather than designating
Northern Orange County as attainment, EPA is joining it with the
Poughkeepsie ozone nonattainment area.
Before and after publication of its November 30, 1992 notice, EPA
received comments from four separate commenters. Further, on January
29, 1993, one of the commenters, Scenic Hudson, Inc., along with the
Environmental Defense Fund, Inc., filed in the United States Court of
the Appeals for the Second Circuit a petition to review the decision to
exclude Northern Orange and Putnam Counties from the NYCMSA. On
February 18, 1994, and April 8, 1994, EPA agreed to reconsider this
decision. This Federal Register notice is intended to meet this
commitment. The comments considered by EPA and the reasons for its
decisions are explained in the remainder of this notice. Additional
information can be found in the technical support document developed
for this action and available at the addresses mentioned in the
beginning of this notice.
Framework of the Clean Air Act
Clauses (i) and (ii) of section 107(d)(4)(A) set out the general
process by which ozone areas were to be designated immediately after
enactment of the Clean Air Act Amendments of 1990. Within specified
time periods, the Governor of each State was to submit a list of areas
within the State, designating each area as attainment, nonattainment,
or unclassifiable. EPA was to promulgate this list, making any
appropriate modifications. In accordance with the definition of a
``nonattainment'' under section 107(d)(1)(A)(i), an area was to be
designated nonattainment if it ``does not meet (or * * * contributes to
ambient air quality in a nearby area that does not meet) [the ozone
ambient air quality standards]''.
Clauses (iv) and (v) of section 107(d)(4)(A) incorporated into this
general process for designating areas a special process for determining
the boundaries of ozone nonattainment areas classified as serious or
higher. Under this process, the boundaries of a nonattainment area
classified as serious or higher that lay within a Metropolitan
Statistical Area (``MSA'') or Consolidated MSA (``CMSA'') were, by
operation of law, expanded to include the entire CMSA, except that the
Governor was authorized to recommend excluding portions of the CMSA
from the nonattainment area if the Governor concluded, and EPA
concurred, that sources in that portion ``do not contribute
significantly to violation of the national ambient air quality
standard''. The Governor and EPA were required, under this provision,
to ``consider factors such as population density, traffic congestion,
commercial development, industrial development, meteorological
conditions, and pollution transport.''
If the State and EPA agreed that a portion of the CMSA should be
excluded from the serious or higher nonattainment area, the State and/
or EPA remained free to designate the portion as appropriate under the
general process specified in clauses (i) and (ii) of section
107(d)(4)(A).
Comments on the Designation of Northern Orange County
All of the commenters objected to the exclusion of Northern Orange
County from the NYCMSA. Three of the four commenters submitted comments
of a general nature and did not provide any technical information for
EPA to use in reconsidering its decision. However, one commenter
provided information on population, industrial and commercial growth,
commuting patterns and population density. This information
supplemented and, in some cases, contradicted information submitted by
the State of New York as part of its January 15, 1992 study of the
NYCMSA boundaries.
In a March 16, 1993 letter EPA recommended that the State consider
this information and supplement its January 15, 1992 study. In response
to the EPA's request, the State of New York undertook an evaluation of
air quality in the Orange and Putnam Counties area using a
photochemical grid model, the Urban Airshed Model. This analysis was
completed and submitted to EPA on June 16, 1993 and supplemented on
April 4, 1994 in response to a request from EPA for clarification.
On February 7, 1994, EPA received additional information and
comments from the New York State Department of Transportation (NYSDOT).
The report sent by the NYSDOT included information on population,
population density, commercial and industrial development, employment,
commuting patterns, congestion, and emissions transport. Overall, the
information did not affect the findings of the Urban Airshed Modeling
analysis, but supported the State's claim that Northern Orange and
Putnam Counties did not contribute significantly to a nonattainment
problem in the NYCMSA, and were more like Dutchess County in the
Poughkeepsie MSA than the NYCMSA.
Based on EPA's evaluation of the information provided by the
commenters and the State, EPA has determined that the State has
demonstrated, for the purposes of section 107(d)(4)(A)(iv)-(v) of the
Act, that sources in Orange County do not contribute significantly to a
violation of the national ambient air quality standard for ozone in the
NYCMSA. Air quality modeling performed by New York State predicts that
emissions from Northern Orange County have the potential to (i) expand
by relatively small amounts the predicted nonattainment area and (ii)
increase by relatively small amounts the ozone concentrations in
several areas downwind, including Putnam County, Fairfield County (part
of the NYCMSA), Dutchess County, and the Hartford, CT nonattainment
area.
However, the model employed by New York State--although very
useful--has several limitations. Most importantly, its input for the
emissions inventory has become outdated, and it models only one ozone
nonattainment episode. Modeling more episodes may yield somewhat
different results that would generate more confidence in the model's
accuracy.
EPA has concluded that the model is directionally sound in that it
implicates Northern Orange County's emissions as contributing to
nonattainment in several areas downwind. However, the limitations of
the model, coupled with the fact that it predicts less-than-
overwhelming impacts of Northern Orange County emissions on areas
within the NYCMSA, means that EPA cannot conclude that the model
implicates Northern Orange County's emissions as significantly
contributing to nonattainment air quality within the NYCMSA, within the
meaning of clause (v) of section 107(d)(4)(A).
Moreover, other information points strongly to the conclusion that
sources in Northern Orange County do not significantly contribute to
the nonattainment problems of the NYCMSA. It should be noted that a
sophisticated air quality model of the type employed by New York State
generally yields the clearest view of one area's contribution to the
air quality of a second area. This is because the stationary, area, and
mobile source emissions within the first area are directly accounted
for and modeled to yield an estimate of their impact on the second
area. However, in this case, the results of the model, and its
limitations, mean that additional information must be closely
considered.
An important additional means for sources in one area to contribute
to the nonattainment problem of a second area is through vehicle
commuting. As discussed more fully in the accompanying technical
support document, the amount of commuting from Orange County into the
NYCMSA is relatively small. This factor indicates that Northern Orange
County does not significantly contribute to the NYCMSA.
Other factors considered include population, populations density,
commercial and industrial development, growth rates, and traffic
congestion. As discussed more fully in the technical support document,
these factors point towards the conclusion that Northern Orange County
is more similar to Dutchess County than to nearby counties in the
NYCMSA. The growth rate in Northern Orange County is high, but this
factor indicates more that Northern Orange County should be designated
nonattainment than it does that this portion of the County must be
linked with the NYCSMA.
For these reasons, EPA reiterates its concurrence in New York's
finding that Northern Orange County should be excluded from the NYCMSA.
However, by this action, EPA is correcting its previous
determination that Northern Orange County should be designated
attainment. Instead, EPA is taking action to designate Northern Orange
County nonattainment, and include it within the boundaries of the
Poughkeepsie nonattainment area. As noted above, the model shows that
Northern Orange contributes to nonattainment in Poughkeepsie as well as
other areas, and thus meets one prong of the definition of a
nonattainment area in section 107(d)(1)(A)(i), which is that the area
``contribute[] to ambient air quality in a nearby area that does not
meet'' ambient air quality standards. As discussed in more detail in
the TSD, Northern Orange County resembles in important respects--
including population and population density--Dutchess County in the
Poughkeepsie area.
Comments on the Designation of Putnam County
Four commenters generally disagreed with EPA's decision in its
November 30, 1992 rule to exclude Putnam County. Because of the general
nature of the comments, no new information of a technical nature was
provided that convinces EPA to reconsider its decision. As described in
more detail in the technical support document, the reasons for
excluding Putnam from the NYCMSA mirror those for excluding Northern
Orange County, except that for Putnam, all the factors involved--
including modelled impact on the NYCMSA, amount of emissions,
commuting, population density, total population, industrial and
commercial development, and growth--make for an even more compelling
case that Putnam does not contribute significantly to the NYCMSA.
In addition, EPA is reaffirming its decision to include Putnam in
the Poughkeepsie nonattainment area. The reasons for this action again
mirror the reasons described above for including Northern Orange County
with the Poughkeepsie area. As described in more detail in the
accompanying technical support document, air quality modeling performed
by the State of New York indicated that Putnam's emissions contributed
to nonattainment problems in several areas, including the NYCMSA.
Because of the limits of the model, coupled with the less-than-
overwhelming impact shown on the NYCMSA, EPA cannot conclude that the
model in-and-of-itself implicates Putnam County's emissions as a
significant contributor to nonattainment in the NYCSMA. However, the
model does implicate Putnam as a contributor--with the highest level of
contribution to Dutchess County--sufficient to designate Putnam as
nonattainment.
One commenter disagreed with EPA's interpretation of the Act.
Scenic Hudson, Inc., claimed that the Act does not allow EPA to move
Putnam County into the Poughkeepsie nonattainment area. However, the
Act in section 107 (d)(4)(A)(v) does not limit EPA's authority under
section 107(d)(4)(A) (i)-(ii) to designate areas that have been
excluded.
Future Bump-Up
In addition, EPA intends to promulgate in the near future a notice
in accord with section 181(b)(2) of the Act, which requires EPA to
``bump up'' the classification to moderate of any marginal
nonattainment areas that did not attain the standard by November 15,
1993. Air monitoring in Dutchess County has recorded four exceedances
of the ozone standard over the past three years (two in each of 1991
and 1993). Thus it appears that the Poughkeepsie area did not attain
the ozone standard by November 15, 1993. EPA's action would include
Dutchess, Putnam and Northern Orange Counties of the Poughkeepsie
nonattainment area.
Error Correction
Based on the information described above, with this rule EPA is
making corrections to the designations, boundaries, and classifications
that were promulgated or announced in the November 6, 1991 rule and the
November 30, 1992 amended rule for the NYCMSA and Poughkeepsie
nonattainment areas. Specifically, EPA is revising the designation of
the Towns of Cornwall, Crawford, Deerpark, Goshen, Greenville,
Hamptonburgh, Middletown, Minisink, Montgomery, Mount Hope, Newburgh,
New Windsor, Port Jervis, Wallkill, Wawayanda and the City of Newburgh
in Northern Orange County from attainment to nonattainment as part of
the Poughkeepsie ozone nonattainment area. These corrections are made
under section 110(k)(6) of the Act which provides as follows:
Whenever the Administrator determines that the Administrator's
action approving, disapproving, or promulgating any plan or plan
revision (or part thereof), area designation, redesignation,
classification, or reclassification was in error, the Administrator
may in the same manner as the approval, disapproval, or promulgation
revise such action as appropriate without requiring any further
submission from the State. Such determination and the basis thereof
shall be provided to the State and public.
The EPA interprets this provision to authorize the Agency to make
corrections to a promulgated regulation when it is shown to EPA's
satisfaction that (1) EPA clearly erred in failing to consider or
inappropriately considered information made available to EPA at the
time of the promulgation, or the information made available at the time
of promulgation is subsequently demonstrated to have been clearly
inadequate; and (2) other information persuasively supports a change in
the regulation. 57 FR 56763 (col. 1) (November 30, 1992).
In this case, EPA has found that the information provided by the
State of New York can justify the exclusion of Northern Orange and
Putnam Counties from the NYCMSA and include them as part of the
Poughkeepsie nonattainment area.
Summary
With this rule, the EPA is (1) reaffirming its January 15, 1992
decision to exclude Northern Orange and Putnam Counties from the NYCMSA
(2) reaffirming its decision to make Putnam County part of the
Poughkeepsie ozone nonattainment area; and (3) correcting its decision
to designate Northern Orange County as attainment and, instead
including it in the Poughkeepsie ozone nonattainment area. This rule
completes a process begun on December 28, 1990 to revise the boundaries
of the NYCMSA.
The effective designation and classification dates for the towns of
Blooming Grove, Chester, Highlands, Monroe, Tuxedo, Warwick, and
Woodbury in Southern Orange County, NY, and for Putnam County, NY,
remains as January 15, 1992.
The effective designation and classification dates for Northern
Orange County, generally in accordance with the effective date
provisions found in the November 30, 1992 corrections rule, 57 FR 56766
(col. 2), are as follows: November 15, 1990 for purposes of determining
the scope of a ``covered area'' under section 211 (k)(10)(D) and opt-in
under section 211 (k)(6); as well as determining the baseline for the
reductions needed to meet the requirement to reduce volatile organic
compounds by 15 percent, under section 182 (b)(1); and April 21, 1994,
for all other purposes, including the applicability of new source
review provisions and other substantive State or Federal pollution
control requirements.
It should be noted that the entire State of New York is part of the
Northeast Ozone Transport Region, and all areas of the State are
subject to certain control requirements regardless of their attainment
status.
List of Subjects in 40 CFR Part 81
Environmental protection, Air pollution control, National parks,
Wilderness areas.
Dated: April 13, 1994.
Carol Browner,
Administrator, Environmental Protection Agency.
PART 81--[AMENDED]
40 CFR Part 81 is amended as follows:
1. The authority citation for part 81 continues to read as follows:
Authority: 42 U.S.C. 7401-7671q.
2. Section 81.300 is amended by revising paragraph (d) (2)(iii) to
read as follows:
Sec. 81.300 Scope.
* * * * *
(d) * * *
(2) * * *
(iii) Determining the scope of a ``covered area'' under section 211
(k)(10)(D) and opt-in under section 211 (k)(6) for the reformulated
gasoline requirement and for purposes of determining the baseline of
the reductions needed to meet the requirement to reduce volatile
organic compounds by 15 percent under section 181 (b)(1). For all other
purposes the effective designation date is January 6, 1992 (except for
the Towns of Blooming Grove, Chester, Highlands, Monroe, Tuxedo,
Warwick, and Woodbury in Orange County, NY, and for Putnam County, NY,
for which the effective date is January 15, 1992, and for the remainder
of Orange County, NY, for which the effective date is April 21, 1994.
* * * * *
Sec. 81.333 [Amended]
3. In Sec. 81.333 the table for ``New York-Ozone'' is amended under
the heading ``New York-Northern New Jersey-Long Island Area'' by
revising the entry for ``Orange County (part)'', the entry for
``Poughkeepsie Area'' and the entry for ``Putnam County''; by revising
the entire entry for the ``AQCR 161 Hudson Valley Intrastate (Remainder
of)''; and by revising footnote number two and by removing footnote
number three to the table to read as follows:
Sec. 81.333 New York.
* * * * *
New York-Ozone
----------------------------------------------------------------------------------------------------------------
Designation Classification
Designated Area ----------------------------------------------------------------------------------------
Date\1\ Type Date\2\ Type
----------------------------------------------------------------------------------------------------------------
* * * * * * *
New York-Northern New
Jersey-Long Island Area
* * * * * * *
Orange County (part) 1/15/92................ Nonattainment......... 1/15/92............... Severe-17.
Blooming Grove,
Chester, Highlands,
Monroe, Tuxedo,
Warwick, and Woodbury.
* * * * * * *
Poughkeepsie area:
Dutchess County.... 1/6/92................. Nonattainment......... 1/6/92................ Marginal.
Orange County [Insert date of this Nonattainment......... [Insert date of this Marginal.
(remainder). rule\2\]. rule\2\].
Putnam County...... 1/15/92................ Nonattainment......... 1/15/92............... Marginal.
* * * * * * *
AQCR 161 Hudson Valley ....................... Unclassifiable/Attainm
Intrastate (Remainder ent..
of). Columbia County
Fulton County
Schoharie County
Ulster County.
* * * * * * *
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\1\This date is November 15, 1990, unless otherwise noted.
\2\However, the effective date is November 15, 1990 for purposes of determining the scope of a ``covered area''
under section 211 (k)(10)(D), opt-in under section 211 (k)(6), and the baseline determination of the 15 %
reduction in volatile organic compounds under section 182 (b)(1).
* * * * *
[FR Doc. 94-9662 Filed 4-20-94; 8:45 am]
BILLING CODE 6560-50-P
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 8F3674/R2054; FRL-4773-5]
Pesticide Tolerances for 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-
dioxolan-2-yl]methyl]-1H-1,2,4-triazole and its metabolites
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes interim tolerances (with an expiration
date of December 31, 1998) for the fungicide 1-[[2- (2,4-
dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole
and its metabolites, determined as 2,4-dichlorobenzoic acid and
expressed as parent compound, in or on the raw agricultural commodities
corn forage at 12.0 parts per million (ppm), corn fodder at 12.0 ppm,
corn grain at 0.1 ppm, sweet corn (kernels plus cobs with husks
removed) at 0.1 ppm, pineapples at 0.1 ppm, pineapple fodder at 0.1
ppm. This rule to establish the maximum permissible levels for residues
of propiconazole in or on the commodities listed above was requested in
petitions submitted by the Ciba-Geigy Corp.
EFFECTIVE DATE: This regulation becomes effective April 11, 1994.
ADDRESSES: Written objections, identified by the document control
number, [PP 8F3674/R2054], may be submitted to: Hearing Clerk (A-110),
Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington,
DC 20460.
FOR FURTHER INFORMATION CONTACT: By mail: Sidney C. Jackson, Acting
Product Manager (PM) 21, Registration Division (7505C), Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Rm. 227, CM #2, 1921 Jefferson Davis
Highway, Arlington, VA 22202, (703) 305- 6900.
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of October 12, 1988 (53 FR 39783), which announced
that the Ciba-Geigy Corp., P.O. Box 18300, Greensboro, NC 27419, had
submitted a pesticide petition (PP 8F3674) to EPA requesting that the
Administrator, pursuant to section 408(d) of the Federal Food, Drug,
and Cosmetic Act, 21 U.S.C. 346a(d), propose to amend 40 CFR 180.434 by
establishing tolerances for the fungicide 1-[[2-(2,4-dichlorophenyl)-4-
propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole and its metabolites,
determined as 2,4-dichlorobenzoic acid and expressed as parent
compound, in or on the commodities celery at 5.0 ppm, corn forage at
10.0 ppm, corn fodder at 10.0 ppm, corn grain at 0.1 ppm, sweet corn
(kernels plus cobs with husks removed) at 0.1 ppm, pineapples at 0.1
ppm, pineapple fodder at 0.1 ppm, legume vegetables (succulent or
dried) at 0.5 ppm and legume vegetables foliage at 5.0 ppm. There were
no adverse comments received by the Agency in response to the notice of
filing. Subsequently, Ciba-Geigy Corporation petitioned the Agency to
amend the proposed tolerances by increasing the tolerances from 10.0 to
12.0 ppm for propiconazole residues in or on each of the two
commodities, corn forage and corn fodder. Also, at the request of Ciba-
Geigy, celery was separated out and regulated under its own petition,
and legumes were withdrawn altogether. The tolerance increases and the
commodity deletions were announced in the Federal Register of July 7,
1993 (58 FR 36409). That notice also repeated Ciba-Geigy Corporation's
request that tolerances be established on corn grain, sweet corn,
pineapples, and pineapple fodder. There were no adverse comments
received by the Agency in response to the amended notice of filing.
Prior to the above notice, in the Federal Register of June 24, 1987 (52
FR 23654), EPA established tolerances for residues of the subject
fungicide on various commodities that included residue levels in the
kidney and liver of cattle, goats, hogs, and horses at 0.2 ppm.
Subsequently, on July 8, 1987, a final rule correction was published in
the Federal Register (52 FR 25602) to add tolerances of 0.2 ppm for
residues in the kidney and liver of poultry and sheep that were
inadvertently dropped from the codified text of the document when the
Agency transmitted it for publication.
In a Federal Register dated June 21, 1989 (54 FR 26044), EPA
announced that tolerances for residues of propiconazole were
established for certain raw agricultural commodities including the
kidney and liver of cattle, goats, hogs, horses, and sheep at 2.0 ppm,
an increase from the previous residue levels of 0.2 ppm. This was an
interim (2 year) tolerance for these commodities with an expiration
date of June 21, 1991. On July 1, 1991, EPA announced in the Federal
Register (56 FR 29900) the extension of the 2.0 ppm tolerance for
propiconazole in the kidney and liver of cattle, goats, hogs, horses
and sheep until June 21, 1993. Another extension, to January 31, 1994,
was announced in the Federal Register of August 11, 1993 (58 FR 42672).
Permanent tolerances for these commodities were announced in the
Federal Register on February 18, 1994 (59 FR 8135).
Available data are insufficient to adequately assess the storage
stability of propiconazole in corn processed products, and information
concerning storage conditions in the poultry metabolism study is
lacking. The interim tolerances were established based upon the
condition that data be submitted to the Agency to fully support
permanent tolerances for these commodities.
Once review of all required residue data is completed, the Agency
will reach a regulatory position on the appropriateness of permanent
tolerances for this chemical in or on these commodities. If EPA decides
permanent tolerances are appropriate, EPA will issue permanent
tolerances in response to the petition. These tolerances will be in the
form of a final rule and subject to the objections and hearing
procedures under the Federal Food, Drug, and Cosmetic Act (FFDCA).
The data submitted in the petition and other relevant materials
have been evaluated. The data considered include the following:
1. Plant and animal metabolism studies.
2. Residue data for crop and livestock commodities.
3. Two enforcement methodologies and multi-residue method testing
data.
4. A rat oral lethal dose (LD50) of 1,517 milligrams/kilogram (mg/
kg) of body weight.
5. A 90-day rat feeding study with a no-observable-effect level
(NOEL) of 12 mg/kg/day.
6. A 90-day dog feeding study with a NOEL of 1.25 mg/kg/day.
7. A rabbit developmental toxicity study with a maternal NOEL of
100 mg/kg/day and a developmental toxicity NOEL of greater than 400 mg/
kg/day (highest dose tested (HDT)).
8. A rat teratology study with a maternal toxicity NOEL of 30 mg/
kg/day and a developmental toxicity NOEL of 30 mg/kg/day.
9. A two-generation rat reproduction study with a reproductive NOEL
of 125 mg/kg/day (HDT) and a developmental toxicity NOEL of 25 mg/kg/
day.
10. A 1-year dog feeding study with a NOEL of 1.25 mg/kg/day.
11. A 2-year rat chronic feeding/carcinogenicity study with a NOEL
of 5 mg/kg/day with no carcinogenic potential under the conditions of
the study up to and including approximately 125 mg/kg, the highest dose
tested.
12. A 2-year mouse chronic feeding/carcinogenicity study with a
NOEL of 15 mg/kg/day and with a statistically significant increase in
combined adenomas and carcinomas of the liver in male mice at
approximately 375 mg/kg/day, the highest dose tested.
13. Ames test with and without activation, negative.
14. A mouse dominant-lethal assay, negative.
15. Chinese hamster nucleus anomaly, negative.
16. Cell transformation assay, negative.
Ciba-Geigy submitted information which resolved the previously
outstanding concerns about the nature of the residue in ruminants, an
explanation of recovery calculations, and an explanation of the crop
field trial protocol. Data gaps exist concerning dosing in the mouse
carcinogenicity study. These data requirements were required under
reregistration, pursuant to the Federal Insecticide, Fungicide, and
Rodenticide Act, 7 U.S.C. 136 et seq.
As part of EPA's evaluation of potential human health risks
propiconazole has been the subject of five Peer Reviews and one
Scientific Advisory Panel (SAP) meeting.
Propiconazole was originally evaluated by the Peer Review Committee
on January 15, 1987 and classified as a Group C (possible human)
carcinogen with a recommendation made for the quantification of
estimated potential human risk using a linearized low-dose
extrapolation. The method resulted in the establishment of a Q* of 7.9
x 10-2 (mg/kg/day)-1.
The Peer Review Committee's decision was presented to the FIFRA
Scientific Advisory Panel on March 2, 1988. The Panel did not concur
with the committee's overall assessment of the weight-of-evidence on
the carcinogenicity of propiconazole. The Panel recommended placing the
chemical in Group D, indicating that the Group C classification was
based on minimal evidence. The Panel's determination that EPA's Group C
classification was based on minimal evidence was due to the fact that
the incidence of liver tumors in male mice only occurred when the mice
were given an excessive chemical dose.
In the second, third, and fourth Peer Reviews that followed, the
Peer Review Committee considered recommendations of the SAP as well as
rebuttals by the registrant. Its conclusion, however, that
propiconazole should be classified as a Group C carcinogen with a
quantification of potential human risk remained unchanged.
As part of a fifth Peer Review, EPA considered additional
information provided by the registrant in support of the registrant's
argument that the high dose was excessively toxic in the mouse
carcinogenicity study. It further argued that the data from the high
dose (2,500 ppm) should not be included in the evaluation of
carcinogenic potential of propiconazole. In support of these arguments,
the registrant provided two subchronic oral toxicity studies in mice.
Ciba-Geigy also provided a reread of the pathology slides from a mouse
oncogenicity study which it felt indicated sufficient concurrent liver
toxicity at 2,500 ppm to document that this dose was excessive. These
findings were not present in the original pathology report. Owing to
the inconsistency in Ciba-Geigy's report and the original report, the
Agency requested that an independent (third) evaluation of the
pathology slides be made to determine if the pathology reported could
be confirmed. The results of this (third) pathology evaluation were
used in the fifth Peer Review in place of data resulting from the
earlier evaluations provided by Ciba-Geigy.
The Peer Review Committee considered the following facts regarding
the toxicology data on propiconazole in a weight-of-evidence
determination of carcinogenic potential:
1. Increased numbers of adenomas (increased trend and pairwise
comparison) were found in the livers of male CD1 mice given 2,500 ppm
of propiconazole in the diet.
2. The treated animals had earlier fatalities than the controls.
3. The numbers of carcinomas were increased (trend only) in male
mice only at the 2,500 ppm dose level. Tumors were not significantly
increased at the 500 ppm dose level. Adenomas observed in the treated
animals were larger and more numerous than those in controls; however,
the tumor type (adenoma) was the same.
4. No excessive number of tumors was found in female mice.
5. In a rat study conducted with acceptable doses of propiconazole,
no excessive numbers of tumors were found.
The Peer Review Committee determined, based on the additional
information submitted by Ciba-Geigy from two 90-day subchronic studies
in mice that the 2,500-ppm dose used in the 2-year chronic study
exceeded the maximum tolerated dose (MTD) based on the endpoint of
hepatic necrosis, and the 500-ppm dose used in the chronic study was
inadequate to assess the carcinogenicity of propiconazole. Based on the
third pathology evaluation of the chronic study, the Peer Review
Committee disagreed with Ciba-Geigy's argument that the study showed
excessive toxicity at the 2,500 ppm-dose. However, the Peer Review
Committee concluded that the 90-day subchronic studies are a better
measure of what would be an MTD.
Based upon these findings, the Peer Review Committee agreed that
the classification for propiconazole should remain a Group C (possible
human) carcinogen and recommended against the previously used Q* (viz.
0.079) for risk assessment purposes. For the purpose of risk
characterization the Peer Review Committee recommended that the
reference dose (RfD) approach should be used for quantification of
human risk. This decision was based on the disqualification of the high
dose (2,500 ppm), making the data inappropriate for the calculation of
Q*. Because the middle dose (500 ppm) was not considered sufficiently
high enough for assessing the carcinogenetic potential of
propiconazole, EPA has requested an additional mouse study at
intermediate dose levels in male mice only. EPA does not expect that
these data will significantly change the above cancer assessment that
propiconazole poses a negligible cancer risk to humans.
The reference dose (RfD) for propiconazole is 0.013 mg/kg/day,
based on a no-observable-effect level (NOEL) of 1.25 mg/kg/day and an
uncertainty factor of 100. The NOEL is taken from a 1-year feeding
study in dogs which demonstrated as an effect irritation of the stomach
in males.
The Agency has evaluated dietary exposure to the fungicide residues
based on the proposed tolerances and the commodities which have
established tolerances using data on anticipated residues and percent
crop treated data. The livestock burden was calculated using
anticipated residues in feed items multiplied by the expected percent
contribution to the diet. This dietary burden was then compared with
available data from feeding studies to determine anticipated residues
in meat and milk. Based on current registered uses of this chemical,
only 3 percent of the RfD is being utilized for the general U.S.
population. The tolerances are expected to elicit only a minor increase
in the percent utilization of the RfD for the general U.S. population.
The most highly exposed subgroups, nursing and nonnursing infants <1
year, have Anticipated Residue Contributions (ARCs) from all published
tolerances of 1.87 x 10-3 and 3.64 x 10-3 mg/kg bwt/day.
These ARCs represent 14% and 28% of the Reference Dose for these
subgroups, respectively. The proposed tolerances will add 0.4% and 1.4%
of the RfD for nursing and nonnursing infants <1 year, respectively.
The nature of the residue in plants and animals is adequately
understood, and adequate analytical methods (gas chromatography) are
available for enforcement purposes. Because of the long lead time for
establishing these tolerances and food additive regulations to
publication of the enforcement methodology in the Pesticide Analytical
Manual, Vol. II, the analytical methodology is being made available in
the interim to anyone interested in pesticide enforcement when
requested from: Calvin Furlow, Public Information Branch, Field
Operations Division (7506C), 401 M St., SW., Washington, DC 20460.
Office location and telephone number: Rm. 1128C, CM #2, 1921 Jefferson
Davis Highway., Arlington, VA 22202 (703) 305-5232.
The pesticide is considered useful for the purpose for which the
tolerances are being sought. For the reasons described above, the
Agency is establishing interim tolerances for residues of 1-[[2-(2,4-
dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole
and its metabolites, determined as 2,4-dichlorobenzoic acid and
expressed as parent compound, in or on the following raw agricultural
commodities: corn forage, 12 ppm; corn fodder, 12 ppm; corn grain, 0.1
ppm; sweet corn (kernels plus cobs with husks removed), 0.1 ppm;
pineapple, 0.1 ppm; and pineapple fodder, 0.1 ppm. Because of
inadequate storage information for the poultry metabolism study, and
lack of storage stability data for propiconazole in corn processed
products, the Agency cannot make a decision on permanent tolerances for
these commodities at this time. However, based on available data the
Agency concludes that the established interim tolerances will not be
injurious to public health. Therefore, the tolerances are established
as set forth below.
Any person adversely affected by this regulation may, within 30
days after publication of this document in the Federal Register, file
written objections with the Hearing Clerk, at the address given above
(40 CFR 178.20). The objections submitted must specify the provisions
of the regulation deemed objectionable and the grounds for the
objections (40 CFR 178.25). Each objection must be accompanied by the
fee prescribed by 40 CFR 180.33(i). If a hearing is requested, the
objections must include a statement of the factual issue(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.127). A
request for a hearing will be granted if the Administrator determines
that the material submitted shows the following: There is a genuine and
substantial issue of fact; there is a reasonable possibility that
available evidence identified by the requestor would, if established,
resolve one or more of such issues in favor of the requestor, taking
into account uncontested claims or facts to the contrary; and
resolution of the factual issue(s) in the manner sought by the
requestor would be adequate to justify the action requested (40 CFR
178.32).
Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator
has determined that regulations establishing new tolerances or food
additive regulations or raising tolerance levels or food additive
regulations or establishing exemptions from tolerance requirements do
not have a significant economic impact on a substantial number of small
entities. A certification statement to this effect was published in the
Federal Register of May 4, 1981 (40 FR 24950).
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to review by the Office of Management and Budget
(OMB)). Under section 3(f), the order defines ``significant regulatory
action'' as action that is likely to result in a rule (1) having an
annual effect on the economy of $100 million or more, or adversely and
materially affecting a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or State,
local or tribal governments or communities (also referred to as
``economically significant''); (2) creating serious inconsistency or
otherwise interfering with an action taken or planned by another
agency; (3) materially altering the budgetary impacts of entitlement,
grants, user fees, or loan programs; or (4) raising novel legal or
policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in this Executive Order. The
Office of Management and Budget has exempted this rule from the
requirements of Executive Order 12866.
List of Subjects in 40 CFR Part 180
Administrative practice and procedures, Agricultural commodities,
Pesticides and pests, Reporting and recordkeeping requirements.
Dated: April 11, 1994.
Douglas D. Campt,
Director, Office of Pesticide Progrms.
Therefore, 40 CFR part 180 is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.434, by adding a new paragraph (c) to read as
follows:
Sec. 180.434 1-[[2-(2,4-Dichlorophenyl)-4-propyl-1,3-dioxolan-2-
yl]methyl]-1H-1,2,4-triazole; tolerances for residues.
* * * * *
(c) Tolerances limited by an expiration date are established for
residues of 1-[[2-(2,4-Dichlorophenyl)-4-propyl-1,3-dioxolan-2-
yl]methyl]-1H-1,2,4-triazole and its metabolites determined as 2,4-
dichlorobenzoic acid and expressed as parent compound, in or on the
following raw agricultural commodities:
------------------------------------------------------------------------
Parts per Expiration
Commodity million Date
------------------------------------------------------------------------
Corn, fodder............................... 12 12/31/98
Corn, forage............................... 12 12/31/98
Corn, grain................................ 0.1 12/31/98
Corn, sweet (kernels, plus cobs with husks
removed).................................. 0.1 12/31/98
Pineapple.................................. 0.1 12/31/98
Pineapple, fodder.......................... 0.1 12/31/98
------------------------------------------------------------------------
[FR Doc. 94-9297 Filed 4-20-94; 8:45 am]
BILLING CODE 6560-50-F