[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.                                                                                                 
                                                                                                                
                                                  * * * * * * *                                                 
----------------------------------------------------------------------------------------------------------------
\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