Designations of Areas for Air Quality Planning Purposes; Amendments and Corrections

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 -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