                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C. 20460

                                                      OFFICE OF CHEMICAL SAFETY
                                                       AND POLLUTION PREVENTION

MEMORANDUM

DATE:	March 27, 2012

SUBJECT:	Tolclofos-methyl.  Occupational and Residential Exposure Assessment for Proposed Seed Treatment Uses on Various Crop Groups

PC Code:  128905
DP Barcode:  D395997
Decision No.:  443921
Registration No.:
Petition No.:  NA
Regulatory Action:  Section 3
Case No.:  NA
Risk Assessment Type:  Single Chemical
TXR No.:  NA
CAS No.:  57018-04-9
MRID No.:  NA
40 CFR:

FROM:	Shalu Shelat, Industrial Hygienist
	Risk Assessment Branch 6
	Health Effects Division (7509P)

THROUGH:	Charles Smith, Risk Assessor
	Risk Assessment Branch 6
	Health Effects Division (7509P)

TO:	Lisa Jones/Mary Waller, Risk Management Team 21
	Herbicide Branch
	Registration Division (7505P)
	Risk Management Division

The Registration Division (RD) requested that the Health Effects Divison (HED) conduct an exposure and risk assessment for a new proposed seed treatment use of tolclofos-methyl on various crop groups including: Root and Tuber Vegetables (Crop Group 1, except potato, sweet potato, and yam bean); Bulb Vegetables (Crop Group 3-01); Leafy Vegetables (except brassica vegetables) (Crop Group 4); Brassica (Cole) Leafy Vegetables (Crop Group 5); Legume Vegetables (Succulent or Dried) (Crop Group 6); Fruiting Vegetables (Crop Group 8-10); Cucurbit Vegetables (Crop Group 9); Cereal Grains (Crop Group 15, except rice and wildrice); Grass Forage, Fodder, and Hay (Crop Group 17); Non-grass Animal Feeds (Forage, Fodder, Straw, and Hay) (Crop Group 18); Herbs and Spices (Crop Group 19); Oilseeds (Crop Group 20, except Cotton); Cotton; Ornamental Flowers; and Conifers. Note: This memorandum was reviewed by the Exposure Science Advisory Council (ExpoSAC) on 11/10/2011.
1.0	EXECUTIVE SUMMARY

Tolclofos-methyl (O-(2,6-dichloro-4-methylphenyl) O-O-dimethyl phosphorothioate) is a new active ingredient which works as a contact fungicide formulated for seed treatment use to provide protection against seed-borne fungal pathogens causing seed decay and seedling damping-off.  Rizolex(TM) Flowable Fungicide contains 42% tolclofos-methyl (4.17 lbs ai per gallon) and is proposed to be used on various seed types.

This document assesses the occupational exposure and risk estimates for the newly proposed seed treatment uses of tolclofos-methyl.  Based on application rate and label information, exposure is expected to occur for short- and intermediate-term durations.  Chronic exposure is not expected for the proposed use patterns.

Proposed Use Profile
The proposed tolclofos-methyl application rates range from 0.00009773 to 0.000489 lb ai/lb seed for seed treatment.  Tolclofos-methyl seed treatment uses are to be applied utilizing mechanical, slurry, or mist-type seed treating equipment.  The product is proposed for both commercial seed treatment facilities and on-farm application, but is not allowed to be applied in  a hopper-box or planter-box at planting time.   The proposed label also states that the product is only to be applied to "true seeds" and is not to be applied on other propagation parts.

Residential Exposure
Residential exposures and risk estimates are not assessed in this document because the proposed uses of tolclofos-methyl do not involve applications by homeowners or commercial applicators in residential settings at this time and there are no existing or proposed residential uses.

Occupational Handlers
Occupational handler exposure is expected for individuals involved in commercial seed treatment (primary handlers) and planting treated seeds (secondary handlers).  Dermal risk estimates were not assessed for this use because systemic toxicity and dermal irritation was not observed at concentrations up to the limit dose (1,000 mg/kg/day) after 3 weeks of exposure (5 days/week for 3 weeks).  The inhalation risk estimates do not exceed HED's LOC (MOE >= 100) and therefore are not of concern to HED.  MOEs for all primary handler seed treatment activities ranged from 14,000 to 51,000,000 and MOEs for secondary handler activities planting treated seed ranged from 147,000 to 870,000,000.

 Occupational Post-Application
The potential for short- and intermediate-term occupational exposure to tolclofos-methyl during post-application activities is unlikely because sustained levels of contact with treated seed is not expected after the seed has been placed in the soil or other planting media.  Therefore, no quantitative post-application assessment is required for exposure to treated seeds that have already been planted.

Label Recommendations
The labeling should state:  Seed that has been treated with this product that is then packaged or bagged for future use must contain the following labeling on the outside of the seed package or bag.
      "Treated Seed - Do Not Use for Food, Feed, or Oil Purposes. Store away from feeds and other foodstuffs.
      When opening this bag or loading/pouring the treated seed, wear a long-sleeved shirt, long pants, shoes, socks, and chemical resistant gloves.  After the seeds have been planted, do not enter or allow worker entry into treated areas during the restricted-entry interval (REI) of 12 hours. Exception: Once the seeds are planted in soil or other planting media, the Worker Protection Standard allows workers to enter the treated area without restriction if there will be no worker contact with the treated seeds in the soil or planting media."

Review of Human Research
This risk assessment relies in part on data from studies in which adult human subjects were intentionally exposed to a pesticide or other chemical.  These data, which include ExpoSAC Policy 14 (SOPs for Seed Treatment), are subject to ethics review pursuant to 40 CFR 26, have received that review, and are compliant with applicable ethics requirements.  For certain studies that review may have included review by the Human Studies Review Board.  Descriptions of data sources as well as guidance on their use can be found at http://www.epa.gov/pesticides/science/handler-exposure-data.html and http://www.epa.gov/pesticides/science/post-app-exposure-data.html.

2.0	HAZARD CHARACTERIZATION

Tolclofos-methyl is an organophosphate with several older toxicity studies (dating back to 1970s) submitted for consideration in risk assessment.  Upon re-evaluation of these old toxicity studies (1970s to 1980s), several studies are now considered unacceptable: 90-day oral rat (MRID No. 00156135) (1982); developmental rat (MRID No. 00156142) (1979); developmental rabbit (MRID No. 00156143) (1982); 3-generation reproduction (MRID No. 00156145) (1985); carcinogenicity mouse (MRID No.00156139) (1983), and chronic/carcinogenicity rat (MRID No. 00156140) (1982).

Based on the re-evaluation of these old toxicity studies, the toxicity database for tolclofos-methyl is not complete but adequate for the proposed non-food seed treatment use. Data from the following studies were used to evaluate the hazard potential of tolclofos-methyl:
- Acute lethality studies (oral, dermal, inhalation, primary eye and dermal irritation, dermal sensitization)
- Subchronic dietary (rat, dog)
- 9-month dietary (mouse)
- 104-week special Cholinesterase (rat)
- Developmental (rat, 41422904)
- Neurotoxicity (acute and subchronic) (rat)
- Metabolism (rat, mouse)
- Immunotoxicity (rat)
- Mutagenicty battery

Tolclofos-methyl is a new active ingredient although it has been registered in other countries (European Union countries) for several years.  A search in PubMed (August 2011) with tolclofos-methyl as a search term resulted in no applicable toxicity studies for risk assessment and no toxicity studies with humans were submitted.  Any future uses (other than seed treatment) requested by the registrant will require several new toxicity studies to fulfill the Revised Part 158 guidelines for either a non-food or a food use.

Tolclofos-methyl has low acute toxicity by oral, dermal, and inhalation routes.  It is not a dermal sensitizer, or a skin or eye irritant.  The acute toxicity profiles of tolclofos-methyl are summarized in Table 1.

             Table 1. Acute Toxicity Profile for Tolclofos-methyl*
                                 Guideline No.
                                  Study Type
                                     MRID
                                    Results
                               Toxicity Category

                                   870.1100
                                Acute oral- rat
                               Acute oral-mouse

                                Acute oral-dog
                                00156124 (1985)
                                00156128 (1978)

                                00156125 (1978)
                      Combined LD50 > 5 g/kg, rats[#]
                         3500 mg/kg (2760-4800), mice

                              >1000 mg/kg/day
                                      IV
                                      III

                                      III
                                   870.1200
                             Acute dermal- rabbit
                                00156126 (1985)
                                 Water vehicle
                               1/5 died by day 5
             No clinical signs after dosing of surviving rabbits.
                               LD50 > 2 g/kg
                                      III
                                   870.1300
                           Acute inhalation  -  rat
                                     -rat
                              41410501 (1986)[@]
                      Powder,non-acceptable/non-guideline

                               41445702 (1983) @
                   25% flowable, unacceptable/non-guideline
                               LC50>= 3.32 mg/L
                             Particles 0.3-5.5um
                          %MMAD 1um or less not met

                              LC50>= 0.146 mg/L
                              MMAD not determined

                                      III

                                      NA

                                   870.2400
                        Primary eye irritation- rabbit
                                00156129 (1985)
 Transient slight conjunctival reaction (24 hrs or less). Not an eye irritant
                                      IV

                                   870.2500
                       Primary Dermal irritation- rabbit
                                00156131 (1985)
                            PIS=0, not an irritant
                                      IV

                                   870.2600
                        Skin sensitization- guinea pig
                                00156131 (1985)
                           Not a contact sensitizer
                                      N/A
*Acute summaries found in TXR006933
[#]Clinical signs (piloerection, hunched posture) in all animals were observed shortly after dosing with complete recovery by 5 days post-dosing.
[@]Studies found in TXR008856

In risk assessments for non-food uses that do not result in residential exposures, PODs are selected for the dermal and inhalation routes of exposure only.  In this case, there is no dermal toxicity and therefore a dermal POD has not been selected and a quantitative dermal assessment not performed.  A quantitative assessment was only performed for the inhalation route. PODs for the acute and chronic dietary and incidental oral exposures are not required to assess risk for non-food uses that do not result in residential exposures, and therefore have not been selected.

Acute and Chronic Dietary
The current proposed use is a non-food seed treatment.  Acute and chronic PODs have not been established for this risk assessment.

Short/Intermediate Dermal
The 21-day dermal rabbit study (non-guideline) was re-evaluated to ensure consistency with current HED policy and practices.  Based upon this re-evaluation, systemic toxicity and dermal irritation was not observed at concentrations up to the limit dose (1,000 mg/kg/day) after 3 weeks of exposure (5 days/week for 3 weeks).  Therefore a quantitative short- and intermediate-term dermal assessment has not been conducted for tolclofos-methyl.

Short/Intermediate Inhalation
The short- and intermediate-term inhalation POD was based on oral toxicity studies since route specific inhalation data are currently unavailable.  The 90-day rat and 6- month dog studies provide the most appropriate PODs to consider for risk assessment.  The 90-day rat and 6-month dog studies were selected as co-critical since they yield similar NOAELs and LOAELs for use in risk assessment.  The NOAEL of 23 mg/kg/day from the 6-month dog study, which is similar to the RBC BMDL10 of 34 mg/kg/day from the 90-day rat study, is the most appropriate POD and protective of the short-term and intermediate-term durations of exposure.  An uncertainty factor of 100x (10x to account for interspecies extrapolation and 10x for intraspecies variation) was applied to the POD.  This POD is considered health protective since the recently submitted ACN and SCN studies resulted in no ChE inhibition or toxicity near the limit dose of 1,000 mg/kg/day.

Carcinogenicity and Cancer Classification
There are no currently registered or proposed food uses for tolclofos-methyl.  Carcinogenicity studies are not required for non-food use chemicals.  Carcinogenicity studies in mice and rats are available for tolclofos-methyl and both of these studies were deemed unacceptable for use in the risk assessment.  These cancer studies would be required under the Revised Part 158 Guidelines should a food use for tolclofos-methyl be requested in the future.

Uncertainty Factors
Food Quality Protection Act (FQPA) considerations do not apply to tolclofos-methyl as the proposed seed treatment uses have been deemed non-food uses.  However, there are three outstanding studies according to revised 40 CFR Part 158 Toxicology Data Requirements.  These studies include a development toxicity study in rabbits, a reproduction study in rats, and an adequate in vivo mammalian cell assay.  The Agency is not requesting any of these studies at this time and does not believe a UFDB is required for the lack of these studies.  Based on the proposed uses, quantification of risk is limited to short- and intermediate-term inhalation exposure for workers.  The PoD used for assessing repeated inhalation exposure is based on the most sensitive endpoint in the most sensitive species (dogs) and supported by the observation of similar effects at a comparable dose in the rat.  Consequently, the risk assessment does not underestimate potential risks to occupational workers and a total uncertainty factor of 100 is adequate.

Table 2.0.  Summary of Toxicological Doses and Endpoints for Tolclofos-Methyl for Non-Food Use Occupational Risk Assessments
                                   Exposure/
                                   Scenario
                           Point of Departure (POD)
                              Uncertainty Factors
                               Level of Concern
                        Study and Toxicological Effects
Acute Dietary (General Population, including Infants and Children)
                 The proposed seed treatment use is non-food.
Chronic Dietary (All Populations)
                 The proposed seed treatment use is non-food.
Dermal (Short/Intermediate)
  Systemic toxicity was not observed up to the limit dose of 1,000 mg/kg/day.
Inhalation
(Short/Intermediate)
                                NOAEL= 23 mg/kg
UFA = 10X
UFH = 10X
                                   MOE = 100
Co-Critical:
1.  6-month dog  (00156138);
LOAEL = 70 mg/kg/day, based on decreased bodyweight and gain, hematocrit, hemoglobin, and erythrocyte count in both sexes.  In addition, ↓relative thyroid weight, ↑ALK and ↑absolute and relative liver wt at high dose.
A consistent dose-response for ChE was not observed.
2. 90-day rat (41422901)
 RBC BMDL10=34 MKD
RBC BMD10=72 MKD
Cancer (oral, dermal, inhalation)
                   Not required for non-food use pesticides.
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and  used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.  NOAEL = no observed adverse effect level.  LOAEL = lowest observed adverse effect level.  UF = uncertainty factor.  UFA = extrapolation from animal to human (interspecies).  UFH = potential variation in sensitivity among members of the human population (intraspecies).

Food Quality Protection Act (FQPA) considerations do not apply to tolclofos-methyl as the proposed seed treatment uses have been deemed non-food uses.  However, there are three outstanding studies according to revised 40 CFR Part 158 Toxicology Data Requirements.  These studies include a development toxicity study in rabbits, a reproduction study in rats, and an adequate in vivo mammalian cell assay.  The Agency is not requesting any of these studies at this time and does not believe a UFDB is required for the lack of these studies.  Based on the proposed uses, quantification of risk is limited to short- and intermediate-term inhalation exposure for workers.  The PoD used for assessing repeated inhalation exposure is based on the most sensitive endpoint in the most sensitive species (dogs) and supported by the observation of similar effects at a comparable dose in the rat.  Consequently, the risk assessment does not underestimate potential risks to occupational workers and a total uncertainty factor of 100 is adequate.

  3.0	PROPOSED USE PATTERNS

Tolclofos-methyl is a new active ingredient being proposed for seed treatment use on various crops, turf grass, ornamental flower, and conifers.  The proposed formulated product is a liquid containing 42.0% tolclofos-methyl active ingredient (4.17 lbs tolclofos-methyl per gallon).  The proposed label is for both commercial and on-farm seed treatment.  The proposed label restricts the use of tolclofos-methyl in hopper-box or planter-box seed treatment systems at planting time.  The proposed label also states that the product is only to be applied to "true seeds" and is not to be applied on other propagation parts.  The application rates range from 0.000489 to 0.00000977 lb ai/lb seed.

Table 3.0:  Use Profile for Proposed Tolclofos-methyl Uses
                 Rizolex Flowable Fungicide (Reg. No. XXX-XXX)
                suspension concentrate (SC), 4.17 lb ai/gallon
                                     Crops
                             Application Equipment
                                    Maximum
                               Application Rate
                                     Notes
- Root and Tuber Vegetables (Crop Group 1A)
  Commercial Seed Treatment Facility and On-Farm Standard Slurry or Mist-Type
                            0.000489 lb ai/lb seed
except Burdock, Chervil, Turnip-Rooted; Ginseng; Horseradish; Salsify; Skirret;
- Cotton

- Bulb Vegetables (Crop Group 3-7)
  Commercial Seed Treatment Facility and On-Farm Standard Slurry or Mist-Type
                           0.00000977 lb ai/lb seed
except Daylily, Bulb; Elegans Hosta; Fritillaria, Bulb; Fritillaria, Leaves; Garlic, Bulb; Garlic, Great-Headed, Bulb; Garlic, Serpent, Bulb; Lily, Bulb; Onion, Chinese, Bulb; Onion, Macrostem; Onion, Tree, Tops; Onion, Welsh, Tops; Shallot, Bulb ; Shallot, Fresh Leaves
- Leafy Vegetables (Crop Group 4)

except Brassica Vegetables
- Brassica (Cole) Leafy Vegetables (Crop Group 5)

- Legume Vegetables (Succulent or Dried) (Crop Group 6)

- Fruiting Vegetables (Crop Group 8-10)

- Cucurbit Vegetables (Crop Group 9)

- Cereal Grains (Crop Group 15)

except Rice and Wildrice
- Grass Forage, Fodder, and Hay (Crop Group 17)

- Non-grass Animal Feeds (Forage, Fodder, Straw, and Hay) (Crop Group 18)

- Herbs and Spices (Crop Group 19)

- Oilseeds (Crop Group 20)

except cotton
- Ornamental Flowers

- Conifers

4.0	RESIDENTIAL (NON-OCCUPATIONAL) EXPOSURE

Residential exposure and risk estimates are not assessed in this document because the proposed uses of tolclofos-methyl do not involve applications by homeowners or commercial applicators in residential settings at this time and there are no existing or proposed residential uses.

5.0	OCCUPATIONAL EXPOSURE/RISK PATHWAY

Occupational handler exposure to tolclofos-methyl is expected for handlers involved in commercial seed treatment and on-farm seed treatment (not for direct use in a hopper-box or planter-box).  However, with respect to treated seed, exposure from post-application activities is unlikely.

5.1	Seed Treatment Occupational Handler

Occupational seed treatment handlers may experience short- and intermediate-term exposure to tolclofos-methyl while performing seed treatment activities in commercial settings.  In addition, occupational secondary handlers may experience short- and intermediate-term exposure while planting tolclofos-methyl -treated seeds.  No chemical-specific handler exposure data were submitted in support of this use pattern.  For assessing commercial seed treatment and seed planting activities, unit exposure data were taken from HED ExpoSAC Policy 14: SOPs for Seed Treatment.  The amount of active ingredient handled depends on the application rate (lb ai/lb seed), the pounds of seed treated in a day, and the pounds of seed that can be planted in a day, all of which vary depending upon the seed type.  Values for the amount of seed treated and planted per day were obtained from HED ExpoSAC Policy 14 and 15 as well as information obtained from the Biological and Economic Analysis Division (BEAD) memo entitled, "Acres Planted per Day and Seeding Rates of Crops Grown in the United States" (J. Becker and S. Ratnayake; 3/24/11).

Treating Seed (Primary Handler)

Potential occupational exposure scenarios from the use of tolclofos-methyl as a commercial seed treatment include:
   * Mixing, loading, applying liquid formulations;
   * Bagging treated seed;
   * Sewing bags; and
   * Multiple activities.

Typically, for large-scale commercial seed treatments, workers perform only those specific individual tasks listed above; however, it is assumed that workers also may perform multiple activities throughout the day.  As a result a "multiple activities" scenario (i.e. where one worker performs all seed treatment tasks such as loading/applying, sewing, bagging, cleaning, calibration, repair, forklift driver, etc.) was addressed.

Planting Treated Seed (Secondary Handler)

Potential occupational exposure scenarios from the use of tolclofos-methyl as a commercial seed treatment include planting treated seed (secondary handler).

Planting treated seed consists of the farmer purchasing bags of treated seed, placing the seed in the hopper and applying seed to fields (considered a secondary handler exposure scenario).
5.3.1	Exposure Data, Factors, and Assumptions

The following are exposure factors and assumptions used to calculate exposure and risk estimates in the occupational assessment for commercial seed treatment scenarios.

Unit Exposures

Chemical-specific data for assessing exposure during commercial seed treatment and seed planting were not submitted to the Agency in support of this Section 3 application. Unit exposures are from ExpoSAC Policy 14: SOPs for Seed Treatment (May 1, 2003).  Unit exposure values from ExpoSAC Policy 14 are based on data for open mixing/loading/application systems.

Amount of Seed Treated Per Day (Primary Handler)

HED is currently in the process of revising ExpoSAC Policy 15: Amount of Seed Treated or Planted per Day (March 2, 2004) in efforts to update the daily amount of seed treated in commercial seed treatment facilities.  With the increasing demand for hybridized treated seeds, there have been modifications not only in the seed treatment equipment, but in the market shares of new and currently registered pesticide products.  HED understands that due to the high cost of producing hybrid seeds, direct seeding is done in a precision manner which requires lower volumes of seed per acre.  However, this does not provide a direct correlation to the amount of seed which is treated in the commercial seed treatment facilities.

The amount of seed treated per day at a commercial facility is summarized below for each crop.
   * Root and Tuber Vegetables (Crop Group 1, except potato, sweet potato, and yam bean)- 5,500 lbs
   * Bulb Vegetables (Crop Group 3-01)- 5,500 lbs
   * Leafy Vegetables (except brassica vegetables) (Crop Group 4) - 5,500 lbs
   * Brassica (Cole) Leafy Vegetables (Crop Group 5) - 5,500 lbs
   * Legume Vegetables (Succulent or Dried) (Crop Group 6) - 5,500 lbs
   * Fruiting Vegetables (Crop Group 8-10) - 5,500 lbs
   * Cucurbit Vegetables (Crop Group 9) - 5,500 lbs
   * Cereal Grains (Crop Group 15, except rice and wildrice) - 718,000 lbs
   * Grass Forage, Fodder, and Hay (Crop Group 17) - 718,000 lbs
   * Non-grass Animal Feeds (Forage, Fodder, Straw, and Hay) (Crop Group 18) - 718,000 lbs
   * Herbs and Spices (Crop Group 19) - 5,500 lbs
   * Oilseeds (Crop Group 20, except Cotton) - 718,000 lbs
   * Cotton  -  160,000 lbs
   * Ornamental Flowers -  5,500 lbs
   * Conifers  -  2,000 lbs

Amount of Seed Planted Per Day (Secondary Handler)

Based on ExpoSAC Policy 15: Amount of Seed Treated or Planted per Day, the amount of seed planted per day is summarized below for each crop.  The amount of seed planted per day incorporates the information available from the BEAD memo entitled, "Acres Planted per Day and Seeding Rates of Crops Grown in the United States" (J. Becker and S. Ratnayake; 3/24/11).  The amount of seed planted per day for ornamental seeds was obtained by researching various ornamental and grower websites to obtain a seeding rate for the flower types identified by the registrant (i.e., zinnias, marigolds, lupine, dianthus, cyclamen, and verbenias).  Typical seeding rates for these types of flowers appear to range from less than 1 lb of seed per acre to 11 lbs of seed per acre.  To be protective of the various seed types, HED assumes that up to 11 lbs of ornamental flower seed can be planted per acre (or 440 lbs of seed planted per day).

   * Root and Tuber Vegetables (Crop Group 1, except potato, sweet potato, and yam bean)- 2,614 lbs
   * Bulb Vegetables (Crop Group 3-01)- 1,004 lbs
   * Leafy Vegetables (except brassica vegetables) (Crop Group 4) - 697 lbs
   * Brassica (Cole) Leafy Vegetables (Crop Group 5) - 211 lbs
   * Legume Vegetables (Succulent or Dried) (Crop Group 6)  -  32,920 lbs
   * Fruiting Vegetables (Crop Group 8-10) - 209 lbs
   * Cucurbit Vegetables (Crop Group 9)  -  726 lbs
   * Cereal Grains (Crop Group 15, except rice and wildrice) - 37,500 lbs
   * Grass Forage, Fodder, and Hay (Crop Group 17)  -  2,800 lbs
   * Non-grass Animal Feeds (Forage, Fodder, Straw, and Hay) (Crop Group 18)  -  12,800 lbs
   * Herbs and Spices (Crop Group 19) - 836 lbs
   * Oilseeds (Crop Group 20, except Cotton) - 2,800 lbs
   * Cotton  -  2,667 lbs
   * Ornamental Flowers -  440 lbs
   * Conifers  -  2,000 lbs

Application Rates

The proposed treatment range is 0.00000977 to 0.000489 lb ai/lb seed for seed treatment.  The maximum application rates are shown above in Table 3.

 Body Weight

The average adult weight of 80 kg was used for estimating inhalation exposure.  No dermal point of departure was selected, therefore a short- and intermediate-term dermal assessment is not being conducted for tolclofos-methyl.

Exposure Duration

It is anticipated that occupational tolclofos-methyl exposures will generally occur in short- (1-30 days) and intermediate- (1-6 months) term durations.

Absorption Factor

Since no inhalation absorption data are available, toxicity by the inhalation route is considered to be equivalent to the estimated toxicity by the oral route of exposure (100% absorption factor).

Equations and Calculations

Daily Exposure
Daily handler exposures are estimated for each applicable handler task with the application rate, the amount of seed treated or seed planted in a day, and the applicable unit exposure using the following formula:

      Daily Exposure (mg ai/day)	=	Unit Exposure (mg ai/lb ai handled) * Application Rate (lbs ai/lb seed) * Daily Amount Handled (lbs seed/day)
      Where:

          Daily Exposure	=	Amount (mg ai/day) deposited on the surface of the skin that is available for dermal absorption or amount inhaled that is available for inhalation absorption,
          Unit Exposure	=	Unit exposure value (mg ai/day),
         Application Rate	=	Normalized application rate based on a logical unit treatment, such as pounds seed or acres; maximum values are used (lb ai/lb seed), and
         Daily Amount Handled	=	Amount seed treated per day (lb seed/day) or amount seed planted per day (lb seed/day).

Daily Dose
Daily dose (dermal or inhalation) was calculated by normalizing the daily dermal or inhalation exposure value by body weight and accounting for dermal and inhalation absorption.

      Average Daily Dose (mg/kg/day) = Daily Exposure (mg ai/day) x {Absorption Factor (%/100)}
      						Body Weight (kg)
      Where:

         Average Daily Dose	=	Absorbed dose received from exposure to a pesticide in a given scenario (mg pesticide active ingredient/kg body weight/day),
         Daily Exposure	=	Amount (mg ai/day) deposited on the surface of the skin that is available for dermal absorption or amount inhaled that is available for inhalation absorption,
         Absorption Factor	=	A measure of the amount of chemical that crosses a biological boundary such as the lungs, and
         Body Weight	=	Body weight determined to represent the population of interest in a risk assessment.

Margin of Exposure (MOE)
The daily inhalation doses received by occupational handlers were compared to the appropriate points of departure (i.e. NOAELs) to assess the risk estimates to occupational handlers for each exposure route.  All MOEs were calculated using the following formula:

      MOE    =	          NOAEL (mg/kg/day)
      		Average Daily Dose (mg/kg/day)
      Where:

         MOE	=	Margin of exposure value used by HED to represent risk or how close a chemical exposure is to being a concern (unitless),
         ADD	=	Average daily dose (ADD) is absorbed dose received from exposure to pesticide, and
         NOAEL	=	Dose level in a toxicity study, where no observed adverse effects occurred in the study.
5.3.2	Seed Treatment Handler Exposure and Risk Estimates Summary

Primary Handler

A summary of the inhalation risk estimates for each seed treatment exposure scenario is presented in Table 5 for short-term and intermediate-term inhalation exposures.

The results of the occupational handler exposure and risk assessment indicate that inhalation risk estimates are not of concern (MOEs >= 100) at baseline attire (i.e., long-sleeved shirt, long pants, shoes and socks) and no respirator.

HED is currently in the process of revising ExpoSAC Policy 15 in efforts to update the daily amount of seed treated in commercial seed treatment facilities.  With the increasing demand for hybridized treated seeds, there have been modifications not only in the seed treatment equipment, but in the market shares of new and currently registered pesticide products.  HED understands that due to the high cost of producing hybrid seeds, direct seeding is done in a precision manner which requires lower volumes of seed per acre.  However, this does not provide a direct correlation to the amount of seed which is treated in the commercial seed treatment facilities. Over the past several years, HED has received submissions from Industry for the use of several seed treatment pesticides which provide a range of daily amounts of vegetable seeds treated (1,000 to 5,500 lbs).  The amount chosen for many of the fruit, vegetable, and ornamental crop groups (5,500 lbs) is conservative.  For Crop Groups 15, 17, 18, and 20 the standard assumption of 718,000 lbs of seed treated is appropriate, as is the 160,000 lbs assumption for cotton.

Based on an email submitted by Scott Enebak, director of the Forest Health Dynamics Laboratory at Auburn University, an average nursery produces 30,000,000 seedlings per year.  As such, 400-500 pounds of nursery tree seeds are treated per day for five days in the spring time during the treating season (enough to sow 30,000,000 seedlings).  Nursery tree seeds can range anywhere from 4,900 seeds/lb to 75,000 seeds/lb, with the majority of seeds falling in the range from 12,000 seeds/lb to 15,000 seeds/lb.  Table 4 shows the variation in the range of pine species seed sizes.  To be protective of the variations in seed size, HED assumes that up to 10,000,000 seeds can be treated per day (or 2,000 lbs, calculated from the most protective value of 4,900 seeds/lb). This value will be used to represent the treatment of conifer seeds.

Table 4.	Amount of Seed Needed to Direct Seed an Acre and the Approximate Number of Seeds/Lb.
                                 Pine Species
                        Pounds of Seed Needed Per Acre
                     Approximate Number of Seeds Per Pound
                                   Loblolly
                                      0.5
                                    18,200
                                     Slash
                                      0.6
                                    13,500
                                   Longleaf
                                      2.5
                                     4,900
                                     Sand
                                      0.6
                                    75,000
a	Data from Forest Regeneration Methods: Natural Regeneration, Direct Seeding and Planting, M. L. Duryea, University of Florida Extension, Institute of Food and Agricultural Sciences, Circular 759, March 1992.

Secondary Handler

Table 6 shows that the planter (secondary handler) short- and intermediate-term inhalation exposure risk estimates result in MOEs ranging from 160,000 to 24,000,000.  These risk estimates do not exceed HED's level of concern (MOE  >= 100) at some level of risk mitigation (i.e., gloves, no respirator) for handlers planting treated seed.

Nursery tree seedling planting is predominantly mechanized, and thus secondary handler exposure to planting treated nursery seeds is expected to be very low.  Pine seeds are planted with seed drills that are capable of drilling several million seeds per day, averaging 6,000,000 seeds per day for medium sized nurseries of average production, equating to an average of 10 acres of seed sown per day (e-mail correspondence with Scott Enebak, Director of Forest Health Dynamics Laboratory, Auburn University).  To be protective of the variations in seed size, HED assumes that up to 10,000,000 seeds can be planted per day in a larger nursery (or 2,000 lbs, calculated from the most protective value of 4,900 seeds/lb). This assumption was determined to be appropriate for conifer seeds as well.

On-Farm Seed Treatment

On-farm seed treatment utilizes similar machinery as commercial seed treatment; the only difference being the size of the equipment.  With the specific label restricting direct product use in hopper-boxes and planter-boxes, the assessed commercial seed treatment exposure and risk estimates are protective of on-farm seed treatment scenarios.

5.4	Seed Treatment Occupational Post-Application Exposures and Risk Estimates

A post-application inhalation exposure assessment is not required as exposure is expected to be negligible.  Seed treatment assessments provide quantitative inhalation exposure assessments for seed treaters and secondary handlers (i.e.planters).  It is expected that these exposure estimates would be protective of most post-application inhalation exposure scenarios.

The potential for post-application exposures following the planting of tolclofos-methyl-treated seeds is unlikely.  Sustained levels of contact with treated seed after it has been placed in the soil or other planting media would not be expected because no routine cultural practice required for the production of agricultural commodities involves such an activity as defined in the no/low contact criteria in the Worker Protection Standard (WPS).  As a result, no quantitative post-application assessment is required for exposure to treated seeds that have already been planted.

The labeling should state:  Seed that has been treated with this product that is then packaged or bagged for future use must contain the following labeling on the outside of the seed package or bag.
      "Treated Seed - Do Not Use for Food, Feed, or Oil Purposes. Store away from feeds and other foodstuffs.
      When opening this bag or loading/pouring the treated seed, wear a long-sleeved shirt, long pants, shoes, socks, and chemical resistant gloves.  After the seeds have been planted, do not enter or allow worker entry into treated areas during the restricted-entry interval (REI) of 12 hours. Exception: Once the seeds are planted in soil or other planting media, the Worker Protection Standard allows workers to enter the treated area without restriction if there will be no worker contact with the treated seeds in the soil or planting media."

Table 5.	Summary of Short- and Intermediate-Term Handler Exposures and Risk Estimates for Tolclofos-methyl
                                   Seed Type
                                  Inhal UE[a]
                                Max App Rate[b]
                                Amt Treated[c]
                                 Inhal Dose[d]
                                 Inhal MOE[e]

                                     mg/lb
                                 lb ai/lb seed
                                  lb seed/day
                                   mg/kg/day
                                   LOC = 100
                   LOADER/APPLICATOR (single layer, gloves)
Root and Tuber Vegetables (Crop Group 1, except potato, sweet potato, and yam bean)
                                    0.00034
                                   0.000489
                                     5,500
                                   1.14E-05
                                   2,000,000
                       Bulb Vegetables (Crop Group 3-01)
                                    0.00034
                                  0.00009773
                                     5,500
                                   2.28E-06
                                  10,000,000
         Leafy Vegetables (except brassica vegetables) (Crop Group 4)
                                    0.00034
                                  0.00009773
                                     5,500
                                   2.28E-06
                                  10,000,000
                Brassica (Cole) Leafy Vegetables (Crop Group 5)
                                    0.00034
                                  0.00009773
                                     5,500
                                   2.28E-06
                                  10,000,000
             Legume Vegetables (Succulent or Dried) (Crop Group 6)
                                    0.00034
                                  0.00009773
                                     5,500
                                   2.28E-06
                                  10,000,000
                     Fruiting Vegetables (Crop Group 8-10)
                                    0.00034
                                  0.00009773
                                     5,500
                                   2.28E-06
                                  10,000,000
                      Cucurbit Vegetables (Crop Group 9)
                                    0.00034
                                  0.00009773
                                     5,500
                                   2.28E-06
                                  10,000,000
            Cereal Grains (Crop Group 15, except rice and wildrice)
                                    0.00034
                                  0.00009773
                                    718,000
                                   2.98E-04
                                    77,000
                 Grass Forage, Fodder, and Hay (Crop Group 17)
                                    0.00034
                                  0.00009773
                                    718,000
                                   2.98E-04
                                    77,000
    Non-grass Animal Feeds (Forage, Fodder, Straw, and Hay) (Crop Group 18)
                                    0.00034
                                  0.00009773
                                    718,000
                                   2.98E-04
                                    77,000
                       Herbs and Spices (Crop Group 19)
                                    0.00034
                                  0.00009773
                                     5,500
                                   2.28E-06
                                  10,000,000
                    Oilseeds (Crop Group 20, except Cotton)
                                    0.00034
                                  0.00009773
                                    718,000
                                   2.98E-04
                                    77,000
                                    Cotton
                                    0.00034
                                   0.000489
                                    160,000
                                   3.33E-04
                                    69,000
                              Ornamental Flowers
                                    0.00034
                                  0.00009773
                                     5,500
                                   6.65E-05
                                    350,000
                                   Conifers
                                    0.00034
                                  0.00009773
                                     2,000
                                   8.31E-07
                                  28,000,000
                        SEWER (single layer, NO gloves)
Root and Tuber Vegetables (Crop Group 1, except potato, sweet potato, and yam bean)
                                    0.00023
                                   0.000489
                                     5,500
                                   7.73E-06
                                   3,000,000
                       Bulb Vegetables (Crop Group 3-01)
                                    0.00023
                                  0.00009773
                                     5,500
                                   1.55E-06
                                  15,000,000
         Leafy Vegetables (except brassica vegetables) (Crop Group 4)
                                    0.00023
                                  0.00009773
                                     5,500
                                   1.55E-06
                                  15,000,000
                Brassica (Cole) Leafy Vegetables (Crop Group 5)
                                    0.00023
                                  0.00009773
                                     5,500
                                   1.55E-06
                                  15,000,000
             Legume Vegetables (Succulent or Dried) (Crop Group 6)
                                    0.00023
                                  0.00009773
                                     5,500
                                   1.55E-06
                                  15,000,000
                     Fruiting Vegetables (Crop Group 8-10)
                                    0.00023
                                  0.00009773
                                     5,500
                                   1.55E-06
                                  15,000,000
                      Cucurbit Vegetables (Crop Group 9)
                                    0.00023
                                  0.00009773
                                     5,500
                                   1.55E-06
                                  15,000,000
            Cereal Grains (Crop Group 15, except rice and wildrice)
                                    0.00023
                                  0.00009773
                                    718,000
                                   2.02E-04
                                    110,000
                 Grass Forage, Fodder, and Hay (Crop Group 17)
                                    0.00023
                                  0.00009773
                                    718,000
                                   2.02E-04
                                    110,000
    Non-grass Animal Feeds (Forage, Fodder, Straw, and Hay) (Crop Group 18)
                                    0.00023
                                  0.00009773
                                    718,000
                                   2.02E-04
                                    110,000
                       Herbs and Spices (Crop Group 19)
                                    0.00023
                                  0.00009773
                                     5,500
                                   1.55E-06
                                  15,000,000
                    Oilseeds (Crop Group 20, except Cotton)
                                    0.00023
                                  0.00009773
                                    718,000
                                   2.02E-04
                                    110,000
                                    Cotton
                                    0.00023
                                   0.000489
                                    160,000
                                   2.25E-04
                                    100,000
                              Ornamental Flowers
                                    0.00023
                                  0.00009773
                                     5,500
                                   4.50E-05
                                    510,000
                                   Conifers
                                    0.00023
                                  0.00009773
                                     2,000
                                   5.62E-07
                                  41,000,000
                       BAGGER (single layer, NO gloves)
Root and Tuber Vegetables (Crop Group 1, except potato, sweet potato, and yam bean)
                                    0.00016
                                   0.000489
                                     5,500
                                   5.38E-06
                                   4,300,000
                       Bulb Vegetables (Crop Group 3-01)
                                    0.00016
                                  0.00009773
                                     5,500
                                   1.08E-06
                                  21,000,000
         Leafy Vegetables (except brassica vegetables) (Crop Group 4)
                                    0.00016
                                  0.00009773
                                     5,500
                                   1.08E-06
                                  21,000,000
                Brassica (Cole) Leafy Vegetables (Crop Group 5)
                                    0.00016
                                  0.00009773
                                     5,500
                                   1.08E-06
                                  21,000,000
             Legume Vegetables (Succulent or Dried) (Crop Group 6)
                                    0.00016
                                  0.00009773
                                     5,500
                                   1.08E-06
                                  21,000,000
                     Fruiting Vegetables (Crop Group 8-10)
                                    0.00016
                                  0.00009773
                                     5,500
                                   1.08E-06
                                  21,000,000
                      Cucurbit Vegetables (Crop Group 9)
                                    0.00016
                                  0.00009773
                                     5,500
                                   1.08E-06
                                  21,000,000
            Cereal Grains (Crop Group 15, except rice and wildrice)
                                    0.00016
                                  0.00009773
                                    718,000
                                   1.40E-04
                                    160,000
                 Grass Forage, Fodder, and Hay (Crop Group 17)
                                    0.00016
                                  0.00009773
                                    718,000
                                   1.40E-04
                                    160,000
    Non-grass Animal Feeds (Forage, Fodder, Straw, and Hay) (Crop Group 18)
                                    0.00016
                                  0.00009773
                                    718,000
                                   1.40E-04
                                    160,000
                       Herbs and Spices (Crop Group 19)
                                    0.00016
                                  0.00009773
                                     5,500
                                   1.08E-06
                                  21,000,000
                    Oilseeds (Crop Group 20, except Cotton)
                                    0.00016
                                  0.00009773
                                    718,000
                                   1.40E-04
                                    160,000
                                    Cotton
                                    0.00016
                                   0.000489
                                    160,000
                                   1.56E-04
                                    150,000
                              Ornamental Flowers
                                    0.00016
                                  0.00009773
                                     5,500
                                   3.13E-05
                                    740,000
                                   Conifers
                                    0.00016
                                  0.00009773
                                     2,000
                                   3.91E-07
                                  59,000,000
MULTIPLE ACTIVITIES (combination of loader/applicator with gloves + no coveralls, sewer without gloves, stacker without gloves)
Root and Tuber Vegetables (Crop Group 1, except potato, sweet potato, and yam bean)
                                    0.0016
                                   0.000489
                                     5,500
                                   5.38E-05
                                    430,000
                       Bulb Vegetables (Crop Group 3-01)
                                    0.0016
                                  0.00009773
                                     5,500
                                   1.08E-05
                                   2,100,000
         Leafy Vegetables (except brassica vegetables) (Crop Group 4)
                                    0.0016
                                  0.00009773
                                     5,500
                                   1.08E-05
                                   2,100,000
                Brassica (Cole) Leafy Vegetables (Crop Group 5)
                                    0.0016
                                  0.00009773
                                     5,500
                                   1.08E-05
                                   2,100,000
             Legume Vegetables (Succulent or Dried) (Crop Group 6)
                                    0.0016
                                  0.00009773
                                     5,500
                                   1.08E-05
                                   2,100,000
                     Fruiting Vegetables (Crop Group 8-10)
                                    0.0016
                                  0.00009773
                                     5,500
                                   1.08E-05
                                   2,100,000
                      Cucurbit Vegetables (Crop Group 9)
                                    0.0016
                                  0.00009773
                                     5,500
                                   1.08E-05
                                   2,100,000
            Cereal Grains (Crop Group 15, except rice and wildrice)
                                    0.0016
                                  0.00009773
                                    718,000
                                   1.40E-03
                                    16,000
                 Grass Forage, Fodder, and Hay (Crop Group 17)
                                    0.0016
                                  0.00009773
                                    718,000
                                   1.40E-03
                                    16,000
    Non-grass Animal Feeds (Forage, Fodder, Straw, and Hay) (Crop Group 18)
                                    0.0016
                                  0.00009773
                                    718,000
                                   1.40E-03
                                    16,000
                       Herbs and Spices (Crop Group 19)
                                    0.0016
                                  0.00009773
                                     5,500
                                   1.08E-05
                                   2,100,000
                    Oilseeds (Crop Group 20, except Cotton)
                                    0.0016
                                  0.00009773
                                    718,000
                                   1.40E-03
                                    16,000
                                    Cotton
                                    0.0016
                                   0.000489
                                    160,000
                                   1.56E-03
                                    15,000
                              Ornamental Flowers
                                    0.0016
                                  0.00009773
                                     5,500
                                   3.13E-04
                                    74,000
                                   Conifers
                                    0.0016
                                  0.00009773
                                     2,000
                                   3.91E-06
                                   5,900,000
a	Unit Exposures from HED Exposure Science Advisory Council Policy 14 (baseline inhalation = no respirator).
b	Application Rates based on proposed label uses for tolclofos-methyl.
c	HED default for lb seed treated per day from HED Exposure Science Advisory Council Policy 15.
d	Daily Inhalation Dose (mg/kg/day) = daily inhalation unit exposure (mg/ - lb ai) x application rate (lb ai/lb seed) x amount treated (lb seed/day) x absorption factor (100%) / -  body weight (80 kg adult).
e	Inhalation MOE = NOAEL (23.0 mg/kg/day for short- and intermediate-term exposure) / Inhalation Dose (mg/kg/day). Level of concern = 100.

Table 6.	Summary of Secondary Handler (Planter) Exposures and Risk Estimates for Tolclofos-methyl (Single Layer, Gloves for Loading Only).
                                   Seed Type
                                Represented by
                            Max lbs of seed/acre[a]
                                  Inhal UE[b]
                                Max App Rate[c]
                          Amt of Seed Planted/Day[d]
                              Inhalation Dose[e]
                               Inhalation MOE[f]

                                 lb seed/acre
                                     mg/lb
                                 lb ai/lb seed
                                  lb seed/day
                                   mg/kg/day
                                   LOC = 100
Root and Tuber Vegetables (Crop Group 1, except potato, sweet potato, and yam bean)
                                    radish
                                      33
                                      3.4
                                   0.000489
                                     2,614
                                   5.43E-05
                                    420,000
                       Bulb Vegetables (Crop Group 3-01)
                                  onion seed
                                      13
                                      3.4
                                  0.00009773
                                     1,004
                                   4.17E-06
                                   5,500,000
         Leafy Vegetables (except brassica vegetables) (Crop Group 4)
                                    spinach
                                       9
                                      3.4
                                  0.00009773
                                      697
                                   2.89E-06
                                   8,000,000
                Brassica (Cole) Leafy Vegetables (Crop Group 5)
                                   broccoli
                                       3
                                      3.4
                                  0.00009773
                                      211
                                   8.76E-07
                                   26,000,00
             Legume Vegetables (Succulent or Dried) (Crop Group 6)
                                  pea, garden
                                      412
                                      3.4
                                  0.00009773
                                    32,920
                                   1.37E-04
                                    170,000
                     Fruiting Vegetables (Crop Group 8-10)
                                  bell pepper
                                       3
                                      3.4
                                  0.00009773
                                      209
                                   8.68E-07
                                  26,000,000
                      Cucurbit Vegetables (Crop Group 9)
                                  watermelon
                                       9
                                      3.4
                                  0.00009773
                                      726
                                   3.02E-06
                                   7,600,000
            Cereal Grains (Crop Group 15, except rice and wildrice)
                                wheat (table 7)
                                      188
                                      3.4
                                  0.00009773
                                    37,500
                                   1.56E-04
                                    150,000
                 Grass Forage, Fodder, and Hay (Crop Group 17)
                              bluegrass, kentucky
                                      35
                                      3.4
                                  0.00009773
                                     2,800
                                   1.16E-05
                                   2,000,000
    Non-grass Animal Feeds (Forage, Fodder, Straw, and Hay) (Crop Group 18)
                                     lupin
                                      160
                                      3.4
                                  0.00009773
                                    12,800
                                   5.32E-05
                                    430,000
                       Herbs and Spices (Crop Group 19)
                                    parsely
                                      10
                                      3.4
                                  0.00009773
                                      836
                                   3.47E-06
                                   6,600,000
                    Oilseeds (Crop Group 20, except Cotton)
                                   safflower
                                      35
                                      3.4
                                  0.00009773
                                     2,800
                                   1.16E-05
                                   2,000,000
                                    Cotton
                                    cotton
                                      13
                                      3.4
                                   0.000489
                                     2,667
                                   5.54E-05
                                    420,000
                              Ornamental Flowers
                                flowers- varied
                                      11
                                      3.4
                                  0.00009773
                                      440
                                   1.83E-06
                                  12,600,000
                                   Conifers
                                     dust
                                      10
                                      3.4
                                  0.00009773
                                     2,000
                                   8.31E-06
                                   2,770,000
a	Information from  "Acres Planted per Day and Seeding Rates of Crops Grown in the United States" (J. Becker and S. Ratnayake; 3/24/11).: Number of seeds per acre (Table 10) / Number of seeds per lb (Table B-1) = Max lbs of seed per acre
b	Unit Exposures from HED Exposure Science Advisory Council Policy 14: Standard Operating Procedures for Seed Treatment  (baseline inhalation = no respirator).
c	Application Rates based on proposed label uses for tolclofos-methyl.
d	Incorporation of acres treated per day from HED Exposure Science Advisory Council Policy 15 and "Acres Planted per Day and Seeding Rates of Crops Grown in the United States" (J. Becker and S. Ratnayake; 3/24/11): Max lbs of seed per acre x acres planted per day (Policy 15 Table 3)
e	Daily Inhalation Dose (mg/kg/day) = daily inhalation unit exposure (mg/ - lb ai) x application rate (lb ai/lb seed) x amount planted (lb seed/day) x absorption factor (100%) / -  body weight (80 kg adult).
f	Inhalation MOE = NOAEL (23 mg/kg/day for short- and intermediate-term exposure) / Inhalation Dose (mg/kg/day). Level of concern = 100.


[Federal Register Volume 76, Number 131 (Friday, July 8, 2011)]
[Rules and Regulations]
[Pages 40242-40246]
[FR Doc No: 2011-17036]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2010-1002; FRL-9430-7]

Approval and Promulgation of Air Quality Implementation Plans;
Indiana; Modifications to Indiana Prevention of Significant
Deterioration and Non-attainment New Source Review Rules

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

-----------------------------------------------------------------------

SUMMARY: EPA is approving Indiana's modifications to its Prevention of
Significant Deterioration (PSD) and Nonattainment New Source Review
(NNSR) rules. The amendments include grammatical changes, corrections
to numbering, addition of definitions consistent with Federal PSD and
NNSR regulations, and removal of references to provisions which were
vacated in the Federal rules. Indiana submitted these rule revisions to
EPA for approval on November 24, 2010. They are consistent with the
current Federal PSD and NNSR regulations.

DATES: This direct final rule will be effective September 6, 2011,
unless EPA receives adverse comments by August 8, 2011. If adverse
comments are received, EPA will publish a timely withdrawal of the
direct final rule in the Federal Register informing the public that the
rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2010-1002, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Pamela Blakley, Chief, Air Permits Section, Air Programs
Branch (AR-18J), U.S. Environmental Protection Agency, 77 West Jackson
Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: Pamela Blakley, Chief, Air Permits Section, Air
Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West
Jackson Boulevard, Chicago, Illinois 60604. Such deliveries are only
accepted during the Regional Office normal hours of operation, and
special arrangements should be made for deliveries of boxed
information. The Regional Office official hours of business are Monday
through Friday, 8:30 a.m. to 4:30 p.m., excluding Federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R05-OAR-
2010-

1002. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the U.S. Environmental
Protection Agency, Region 5, Air and Radiation Division, 77 West
Jackson Boulevard, Chicago, Illinois 60604. This facility is open from
8:30 AM to 4:30 PM, Monday through Friday, excluding Federal holidays.
We recommend that you telephone Charmagne Ackerman, Environmental
Engineer, at<PHONE_NUMBER> before visiting the Region 5 office.

FOR FURTHER INFORMATION CONTACT: Charmagne Ackerman, Environmental
Engineer, Air Permits Section, Air Programs Branch (AR-18J), U.S.
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What is being addressed in this document?
II. What are the changes that EPA is approving?
III. What action is EPA taking?
IV. Statutory and Executive Order Reviews.

I. What is being addressed in this document?

    We are approving amendments to Indiana's PSD and Emission Offset
regulations. Previously, EPA approved revisions to these regulations
into the State Implementation Plan (SIP) on June 18, 2007 (72 FR
33395). On November 24, 2010, the Indiana Department of Environmental
Management (IDEM) requested that EPA approve PSD and Emission Offset
rule amendments to the SIP. The rule amendments include grammatical
changes, corrections to numbering notation, the addition of definitions
consistent with Federal PSD and NNSR regulations, and removal of
references to provisions which were vacated in the New Source Review
(NSR) Reform Rules. These amendments are contained in Indiana's PSD
rules at 326 IAC 2-2-1, 326 IAC 2-2-2, 326 IAC 2-2-4, 326 IAC 2-2-5,
326 IAC 2-2-7, 326 IAC 2-2-8 and 326 IAC 2-2-10, and Emission Offset
rules at 326 IAC 2-3-1, 326 IAC 2-3-2, and 326 IAC 2-3-3.

II. What are the changes that EPA is approving?

    On December 31, 2002, EPA published final rule changes to the PSD
and NSR programs (67 FR 80186) (2002 NSR Reform Rules), and on November
7, 2003, EPA published a notice of final action on the reconsideration
of the December 31, 2002 final rule changes (68 FR 63021). After the
2002 NSR Reform Rules were finalized and effective (March 3, 2003),
various petitioners challenged numerous aspects, along with portions of
EPA's 1980 PSD and NNSR Rules (45 FR 5276, August 7, 1980). On June 24,
2005, the United States Circuit Court of Appeals for the DC Circuit
Court issued a decision on the challenges to the 2002 NSR Reform Rules.
See New York v. United States, 413 F.3d 3 (DC Cir. 2005). In summary,
the DC Circuit Court vacated portions of the 2002 NSR Reform Rules
pertaining to ``clean units'' and ``pollution control projects''
(PCPs), remanded a portion of the ``reasonable possibility'' provisions
(40 CFR 52.21(r)(6) and 40 CFR 51.166(r)(6)), and either upheld or did
not comment on the other provisions included as part of the 2002 NSR
Reform Rules.
    On June 13, 2007 (72 FR 32526), EPA took final action to revise the
2002 NSR Reform Rules to remove from Federal law all provisions
pertaining to clean units and the PCP exemption that were vacated by
the DC Circuit Court. In the final partial approval of the NSR Reform
rules into the Indiana SIP (72 FR 33395), EPA did not take action on
the clean unit and PCP portions of the rules at IDEM's request.
Although today's action is proposing to approve Indiana's removal of
these provisions, EPA never approved them into the SIP. Indiana has
removed the following rules due to references to clean units and PCPs:
326 IAC 2-2-1(m), (dd)(2)(H), (ii)(6)(D), and (ll); 326 IAC 2-2-2
(d)(5) and (f); 2-2-4(a)(3); 2-2-5(b); 2-3-1(j), (y)(2)(H),
(cc)(3)(B)(iii), and (cc)(3)(B)(iv)(EE),(gg); 326 IAC 2-3-2(c)(5) and
(l); and 326 IAC 2-3-3(b)(12). Additionally, IDEM has removed
references to clean units and PCPs in 326 IAC 2-2-4(a) and (b); 2-2-
7(a); 2-2-8(b); and 2-2-10; 2-3-2(m), but the remainder of those
subsections remain intact.
    In New York v. United States, the DC Circuit also remanded EPA's
``reasonable possibility'' provision, which identifies for sources and
reviewing authorities the circumstances under which a major stationary
source undergoing a modification that does not trigger major NSR must
keep records. On December 21, 2007, EPA addressed the Court's remand,
and took final action to establish that a ``reasonable possibility''
applies where source emissions equal or exceed 50 percent of the Clean
Air Act (CAA) NSR significance levels for any pollutant (72 FR 72607).
See 40 CFR 52.21(r)(b). IDEM added 326 IAC 2-2-8(b)(6) and 326 IAC 2-3-
2(l)(6) to include provisions that are consistent with EPA's reasonable
possibility language.
    The November 7, 2003, reconsideration rule added the definition for
``replacement unit'' at 40 CFR 52.21 (b)(33), which means an emissions
unit for which all the criteria listed in paragraphs (b)(33)(i) through
(iv) of this section are met. No creditable emission reductions shall
be generated from shutting down the existing emissions unit that is
replaced. The definition has been added to Indiana's regulations at 326
IAC 2-2-1(tt) and 326 IAC 2-3-1(nn).
    IDEM has also added ``oxides of nitrogen'' (unless a NOX
waiver is in effect) to the following sections of the Emission Offset
rules: 326 IAC 2-3-1(p), (y), (z), (pp); 326 IAC 2-3-2(b) and (g); and
326 IAC 2-3-3(a)(5)(B). Oxides of

nitrogen were added pursuant to section 182(f) of the CAA as it is a
known precursor to the formation of ozone.
    IDEM's revisions in 326 IAC 2-2-1 through 2-2-5, 326 IAC 2-2-7, 326
IAC 2-2-8, 326 IAC 2-2-10, and 326 IAC 2-3-1 through 2-3-3 also include
corrections to grammatical errors, use of acronyms and corrections to
numbering notations due to several subsections being added and removed.

III. What action is EPA taking?

    EPA is approving the revisions to the PSD rules at 326-IAC 2-2-1,
326 IAC 2-2-2, 326 IAC 2-2-4, 326 IAC 2-2-5, 326 IAC 2-2-7, 326 IAC 2-
2-8 and 326 IAC 2-2-10, and Emission Offset rules at 326 IAC 2-3-1, 326
IAC 2-3-2, and 326 IAC 2-3-3.
    We are publishing this action without prior proposal because we
view this as a noncontroversial amendment and anticipate no adverse
comments. However, in the proposed rules section of this Federal
Register publication, we are publishing a separate document that will
serve as the proposal to approve the state plan if relevant adverse
written comments are filed. This rule will be effective September 6,
2011 without further notice unless we receive relevant adverse written
comments by August 8, 2011. If we receive such comments, we will
withdraw this action before the effective date by publishing a
subsequent document that will withdraw the final action. All public
comments received will then be addressed in a subsequent final rule
based on the proposed action. EPA will not institute a second comment
period. Any parties interested in commenting on this action should do
so at this time. Please note that if EPA receives adverse comment on an
amendment, paragraph, or section of this rule and if that provision may
be severed from the remainder of the rule, EPA may adopt as final those
provisions of the rule that are not the subject of an adverse comment.
If we do not receive any comments, this action will be effective
September 6, 2011.

IV. Statutory and executive order reviews.

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have Tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on Tribal governments or preempt Tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by September 6, 2011. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of today's Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: June 28, 2011.
Susan Hedman,
Regional Administrator, Region 5.
    40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart P--Indiana

0
2. In Sec.  52.770 the table in paragraph (c) is amended by revising
the entry for ``Article 2. Permit Review Rules'' to read as follows:

Sec.  52.770  Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Indiana Regulations
----------------------------------------------------------------------------------------------------------------
                                                           Indiana
     Indiana citation                Subject           effective date      EPA approval date           Notes
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
                                         Article 2. Permit Review Rules
----------------------------------------------------------------------------------------------------------------
                                          Rule 1.1. General Provisions
----------------------------------------------------------------------------------------------------------------
2-1.1-6...................  Public notice............       6/26/1999  6/27/2003, 68 FR 38197...
2-1.1-7...................  Fees.....................       9/10/2004  6/18/2007, 72 FR 33395...
2-1.1-8...................  Time periods for                6/26/1999  6/27/2003, 68 FR 38197...
                             determination on permit
                             applications.
2-1.1-9.5.................  General provisions; term       12/16/2007  10/6/2009, 74 FR 51240...
                             of permit.
----------------------------------------------------------------------------------------------------------------
                       Rule 2. Prevention of Significant Deterioration (PSD) Requirements
----------------------------------------------------------------------------------------------------------------
2-2-1.....................  Definitions..............      10/31/2010  7/8/2011, [Insert page
                                                                        number where the
                                                                        document begins].
2-2-2.....................  Applicability............      10/31/2010  7/8/2011, [Insert page
                                                                        number where the
                                                                        document begins].
2-2-3.....................  Control technology              9/10/2004  6/18/2007, 72 FR 33395...
                             review; requirements.
2-2-4.....................  Air quality analysis;          10/31/2010  7/8/2011, [Insert page
                             requirements.                              number where the
                                                                        document begins].
2-2-5.....................  Air quality impact;            10/31/2010  7/8/2011, [Insert page
                             requirements.                              number where the
                                                                        document begins].
2-2-6.....................  Increment consumption;          9/10/2004  6/18/2007, 72 FR 33395...
                             requirements.
2-2-8.....................  Source obligation........      10/31/2010  7/8/2011, [Insert page
                                                                        number where the
                                                                        document begins].
2-2-10....................  Source information.......      10/31/2010  7/8/2011, [Insert page
                                                                        number where the
                                                                        document begins].
2-2-11....................  Stack height provisions..       4/22/2001  6/27/2003, 68 FR 38197...
2-2-12....................  Permit rescission........        4/8/2004  5/20/2004, 69 FR 29071...
2-2-13....................  Area designation and            4/22/2001  6/27/2003, 68 FR 38197...
                             redesignation.
2-2-15....................  Public participation.....       4/22/2001  6/27/2003, 68 FR 38197...
2-2-16....................  Ambient air ceilings.....       4/22/2001  6/27/2003, 68 FR 38197...
----------------------------------------------------------------------------------------------------------------
                    Rule 2.4. Actuals Plantwide Applicability Limitations in Attainment Areas
----------------------------------------------------------------------------------------------------------------
2-2.4-1...................  Applicability............       9/10/2004  6/18/2007, 72 FR 33395...
2-2.4-2...................  Definitions..............       9/10/2004  6/18/2007, 72 FR 33395...
2-2.4-3...................  Permit application              9/10/2004  6/18/2007, 72 FR 33395...
                             requirements.
2-2.4-4...................  General requirements for        9/10/2004  6/18/2007, 72 FR 33395...
                             establishing PALs.
2-2.4-5...................  Public participation            9/10/2004  6/18/2007, 72 FR 33395...
                             requirements for PALs.
2-2.4-6...................  Establishing a 10 year          9/10/2004  6/18/2007, 72 FR 33395...
                             actuals PAL level.
2-2.4-7...................  Contents of the PAL             9/10/2004  6/18/2007, 72 FR 33395...
                             permit.
2-2.4-8...................  PAL effective period and        9/10/2004  6/18/2007, 72 FR 33395...
                             reopening of the PAL
                             permit.
2-2.4-9...................  Expiration of a PAL......       9/10/2004  6/18/2007, 72 FR 33395...
2-2.4-10..................  Renewal of a PAL.........       9/10/2004  6/18/2007, 72 FR 33395...
2-2.4-11..................  Increasing a PAL during         9/10/2004  6/18/2007, 72 FR 33395...
                             the PAL effective period.
2-2.4-12..................  Monitoring requirements         9/10/2004  6/18/2007, 72 FR 33395...
                             for PALs.
2-2.4-13..................  Record keeping                  9/10/2004  6/18/2007, 72 FR 33395...
                             requirements.
2-2.4-14..................  Reporting and                   9/10/2004  6/18/2007, 72 FR 33395...
                             notification
                             requirements.
2-2.4-15..................  Termination and                 9/10/2004  6/18/2007, 72 FR 33395...
                             revocation of a PAL.
----------------------------------------------------------------------------------------------------------------
                                             Rule 3. Emission Offset
----------------------------------------------------------------------------------------------------------------
2-3-1.....................  Definitions..............      10/31/2010  7/8/2011, [Insert page
                                                                        number where the
                                                                        document begins].
2-3-2.....................  Applicability............      10/31/2010  7/8/2011, [Insert page
                                                                        number where the
                                                                        document begins].
2-3-3.....................  Applicable requirements..      10/31/2010  7/8/2011, [Insert page
                                                                        number where the
                                                                        document begins].
2-3-4.....................  Banking of emission            12/13/1993  10/7/1994, 59 FR 51108...
                             offsets.
2-3-5.....................  Location of offsetting         12/13/1993  10/7/1994, 59 FR 51108...
                             emissions.
----------------------------------------------------------------------------------------------------------------
                  Rule 3.4. Actuals Plantwide Applicability Limitations in Nonattainment Areas
----------------------------------------------------------------------------------------------------------------
2-3.4-1...................  Applicability............       9/10/2004  6/18/2007, 72 FR 33395...
2-3.4-2...................  Definitions..............       9/10/2004  6/18/2007, 72 FR 33395...
2-3.4-3...................  Permit application              9/10/2004  6/18/2007, 72 FR 33395...
                             requirements.
2-3.4-4...................  Establishing PALs;              9/10/2004  6/18/2007, 72 FR 33395...
                             general requirements.
2-3.4-5...................  Public participation            9/10/2004  6/18/2007, 72 FR 33395...
                             requirements for PALs.

2-3.4-6...................  Establishing a 10 year          9/10/2004  6/18/2007, 72 FR 33395...
                             actuals PAL level.
2-3.4-7...................  Contents of the PAL             9/10/2004  6/18/2007, 72 FR 33395...
                             permit.
2-3.4-8...................  PAL effective period and        9/10/2004  6/18/2007, 72 FR 33395...
                             reopening of the PAL
                             permit.
2-3.4-9...................  Expiration of a PAL......       9/10/2004  6/18/2007, 72 FR 33395...
2-3.4-10..................  Renewal of a PAL.........       9/10/2004  6/18/2007, 72 FR 33395...
2-3.4-11..................  Increasing a PAL during         9/10/2004  6/18/2007, 72 FR 33395...
                             the PAL effective period.
2-3.4-12..................  Monitoring requirements         9/10/2004  6/18/2007, 72 FR 33395...
                             for PALs.
2-3.4-13..................  Record keeping                  9/10/2004  6/18/2007, 72 FR 33395...
                             requirements.
2-3.4-14..................  Reporting and                   9/10/2004  6/18/2007, 72 FR 33395...
                             notification
                             requirements.
2-3.4-15..................  Termination and                 9/10/2004  6/18/2007, 72 FR 33395...
                             revocation of a PAL.
----------------------------------------------------------------------------------------------------------------
                                      Rule 5.1. Construction of New Sources
----------------------------------------------------------------------------------------------------------------
2-5.1-4...................  Transition procedures....       9/10/2004  6/18/2007, 72 FR 33395...
----------------------------------------------------------------------------------------------------------------
                                           Rule 6. Emission Reporting
----------------------------------------------------------------------------------------------------------------
2-6-1.....................  Applicability............       8/13/2006  3/29/2007, 72 FR 14678...
2-6-2.....................  Definitions..............       3/27/2004  10/29/2004, 69 FR 63069..
2-6-3.....................  Compliance schedule......       8/13/2006  3/29/2007, 72 FR 14678...
2-6-4.....................  Requirements.............       8/13/2006  3/29/2007, 72 FR 14678...
2-6-5.....................  Additional information          3/27/2004  10/29/2004, 69 FR 63069..
                             requests.
----------------------------------------------------------------------------------------------------------------
                          Rule 8. Federally Enforceable State Operating Permit Program
----------------------------------------------------------------------------------------------------------------
2-8-1.....................  Definitions..............       6/24/1994  8/18/1995, 60 FR 43008...
2-8-2.....................  Applicability............       6/24/1994  8/18/1995, 60 FR 43008...
2-8-3.....................  Permit application.......       6/24/1994  8/18/1995, 60 FR 43008...
2-8-4.....................  Permit content...........      12/16/2007  10/6/2009, 74 FR 51240...
2-8-5.....................  Compliance requirements         6/24/1994  8/18/1995, 60 FR 43008...
                             for FESOPs.
2-8-6.....................  Federally enforceable           6/24/1994  8/18/1995, 60 FR 43008...
                             requirements.
2-8-7.....................  Permit issuance, renewal,       6/24/1994  8/18/1995, 60 FR 43008...
                             and revisions.
2-8-8.....................  Permit reopening.........       6/24/1994  8/18/1995, 60 FR 43008...
2-8-9.....................  Permit expiration........       6/24/1994  8/18/1995, 60 FR 43008...
2-8-10....................  Administrative permit           6/24/1994  8/18/1995, 60 FR 43008...
                             amendments.
2-8-11....................  Permit modification             6/24/1994  8/18/1995, 60 FR 43008...
                             (Repealed).
2-8-11.1..................  Permit revisions.........       6/24/1994  8/18/1995, 60 FR 43008...
2-8-12....................  Emergency provision......       6/24/1994  8/18/1995, 60 FR 43008...
2-8-13....................  Public notice............       6/24/1994  8/18/1995, 60 FR 43008...
2-8-14....................  Review by U.S. EPA.......       6/24/1994  8/18/1995, 60 FR 43008...
2-8-15....................  Operational flexibility..       6/24/1994  8/18/1995, 60 FR 43008...
2-8-16....................  Fees.....................       6/24/1994  8/18/1995, 60 FR 43008...
2-8-17....................  Local agencies...........       6/24/1994  8/18/1995, 60 FR 43008...
----------------------------------------------------------------------------------------------------------------
                               Rule 9. Source Specific Operating Agreement Program
2-9-1.....................  General provisions.......       6/24/1994  4/2/1996, 61 FR 14487....
2-9-2.....................  Source specific                 6/24/1994  4/2/1996, 61 FR 14487....  Sec. 2(a),
                             restrictions and                                                      2(b), and
                             conditions (Repealed).                                                2(e)
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-17036 Filed 7-7-11; 8:45 am]
BILLING CODE 6560-50-P