UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

  SEQ CHAPTER \h \r 1 WASHINGTON, D.C.  20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

DATE: 	October 12, 2010

  SEQ CHAPTER \h \r 1 MEMORANDUM

SUBJECT:	  SEQ CHAPTER \h \r 1 Fomesafen Sodium: Chronic Dietary Exposure Assessment to Support Proposed New Use on Potatoes and Peppers.

PC Code:  123802	DP Barcode:  D382064

Decision No.:  425353	Registration No.:  100-993

Petition Nos:  9F7563 (potato), 9F7667 (pepper)	Regulatory Action:  Section 3 and Registration

Risk Assessment Type:  NA	Case No.:  NA

TXR No.:  NA	CAS No.:  72178-02-0

MRID No.:  NA	40 CFR:  §180.433

FROM:	Alexandra LaMay, Biologist

		Risk Assessment Branch VII

		Health Effects Division (7509P)

THROUGH:	Breann Hanson  SEQ CHAPTER \h \r 1 , Chemist

Thurston Morton, Chemist

Dietary Exposure Science Advisory Council (DESAC)

		Health Effects Division (7509P)

			and

		Michael S. Metzger, Branch Chief

		Risk Assessment Branch VII

		Health Effects Division (7509P)

TO:		  SEQ CHAPTER \h \r 1 Michael Walsh, PM Team 23

	Herbicide Branch

	Registration Division (7505P)

This document is a revision of the Chronic Dietary Exposure Assessments dated January 21, 2010 (C. Olinger).  The dietary assessments have been updated t湩汣摵桴牰灯獯摥渠睥甠敳⁳景映浯獥晡湥椠 ⽮湯瀠瑯瑡敯⁳湡数灰牥⹳†഍–䕓⁑䡃偁䕔⁒桜尠 ⁲ᔱ硅捥瑵癩畓浭牡൹

Chronic dietary risk assessments were conducted using the Dietary Exposure Evaluation Model (DEEM-FCID™), Version 2.03, which used food consumption data from the United States Department of Agriculture’s (USDA’s) Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The analyses were performed to support a proposed new use of fomesafen sodium (commonly called fomesafen) on potatoes and peppers.

No acute dietary toxicity endpoint could be identified based on the toxicology data currently available for fomesafen sodium.  The Cancer Assessment Review Committee (CARC) classified fomesafen as “Not likely to be carcinogenic to humans;” therefore, a cancer assessment was not performed.

  SEQ CHAPTER \h \r 1 Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization

Chronic dietary exposure assessments were performed for fomesafen sodium.  The assumptions of these unrefined assessments were tolerance level residues, 100% crop treated, and default DEEM processing factors.  Estimated drinking water concentrations (EDWCs) from the Environmental Fate and Effects Division (EFED) were also included.  The dietary exposure analyses in this assessment result in dietary risk estimates for food and water that are below the Agency’s level of concern for chronic dietary exposure for all population subgroups.  The exposure for food plus drinking water to the general U.S. population is 12% of the chronic population adjusted dose (cPAD).  The subgroup with the highest exposure and risk estimates is infants.  For infants, the exposure for food plus drinking water was 0.000813 mg/kg/day, which represents 32% of the cPAD.

  SEQ CHAPTER \h \r 1 I.  Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the population adjusted dose (PAD).  The PAD is equivalent to point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  HED is generally concerned when estimated cancer risk exceeds one in one million. References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site:  “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 21-JUN-2000, web link:      HYPERLINK "http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf"  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf ; or see SOP 99.6 (20-AUG-1999).

The most recent dietary risk assessment for fomesafen was conducted by Christine Olinger (1/21/2010, DP No. 372850).

  SEQ CHAPTER \h \r 1 II.  Residue Information

  SEQ CHAPTER \h \r 1 Fomesafen sodium is a contact herbicide in the diphenylether chemical class and acts via inhibition of protoporphyrinogen oxidase (PPO).  It is used to control broadleaf and grass weeds, as well as postemergence weeds in soybeans and other legumes.

  SEQ CHAPTER \h \r 1 Tolerances for fomesafen residues are listed in 40 CFR §180.433.  Currently tolerances are established for fomesafen acid in soybeans, dry beans, and snap (succulent) beans at 0.05 ppm and cotton gin by-products and cottonseed at 0.025 ppm.  Since then, HED has recommended that tolerances on dry beans and snap (succulent) beans be reduced to 0.025 ppm and the tolerance on soybeans be reduced to 0.02 ppm (D. Davis, DP No. D325801, 4/25/06).  The registrant has also since proposed new tolerances and uses on tomatoes and potatoes; however, insufficient residue data were available for potatoes.  Therefore, only a tolerance of 0.025 ppm in/on tomatoes was recommended (C. Olinger, DP No. 365199, 1/21/2010).  Since then, a confined rotational crop metabolism study has been submitted that satisfies the data gap for potatoes, therefore it has been recommended for a tolerance of 0.025 ppm in/on potatoes.  In this petition, the registrant has proposed a new tolerance and use on peppers.  Based on the residue data available, HED is recommending for a tolerance of 0.025 ppm in/on peppers (A. LaMay, DP No. 373544 and 382067, 10/12/2010).

-α,α,α-trifluoro-p-tolyloxy) anthranilic acid and 5-(2-chloro-α,α,α-trifluoro-p-tolyloxy)-N-methylsulfonylanthranilamid e.  However, based on the submitted livestock metabolism studies HED concluded that the proposed/registered uses of fomesafen result in a 40 CFR §180.6(a)(3) situation for livestock commodities; i.e., there is no reasonable expectation of finite residues in livestock commodities.

Tolerance level residues and 100% crop treated were used for all commodities included in these assessments.  The tomato processing study previously submitted was inadequate due to the lack of detectable residues in/on the raw commodity.  Therefore, default tomato paste, dried tomato, tomato juice, and tomato puree concentration factors were used for these processed commodities.  The potato processing study previously submitted was also inadequate due to lack of detectable residues in/on the raw commodity.  Therefore, default dried potato concentration factors were used for these processed commodities.

  Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by the Environmental Fate and Effects Division (EFED) in the following memoranda:

Hetrick, James.  DP Barcode: D322213. October 3, 2005. Revised Tier II Drinking Water Assessment for Fomesafen use on cotton, soybeans, dry beans, and snap beans

Lin, James.  DP Barcode: D365204.  December 10, 2009.  Drinking Water Assessment for Fomesafen use on cotton, soybeans, dry beans, snap beans, potato and tomato.

Lin, James.  DP Barcode: D373599 and 373601.  March 2, 2010.  Drinking Water Assessment for Fomesafen use on Pepper.

The estimated drinking water concentrations (EDWCs) were incorporated directly into DEEM-FCID under the food categories “water, direct, all sources” and “water, indirect, all sources.”

The scenario leading to the highest EDWC in surface water for chronic exposure (1-in-10 year annual mean concentration) using Pesticide Root Zone Model- Exposure Analysis Modeling System (PRZM-EXAMS) was MS cotton, aerial application, with a concentration of 10.535 ppb, adjusted for a Percent Crop Area (PCA) of 0.87.  This value was used directly in the dietary exposure assessment.

Syngenta submitted a prospective ground water monitoring study for fomesafen use on soybeans.  EFED recommended using the ground water monitoring concentration of 1 ppb, since it represents actual use conditions of fomesafen on soybeans on a vulnerable soil.  Since this value was lower than the surface water EDWC, only the surface water value was incorporated into the assessment.

The model and its description are available at the EPA internet site:   HYPERLINK "http://www.epa.gov/oppefed1/models/water/"  http://www.epa.gov/oppefed1/models/water/ .

  SEQ CHAPTER \h \r 1 IV.  Program and Consumption Information

Fomesafen sodium chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID™, Version 2.03), which incorporates consumption data from USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII), 1994-1996 and 1998.  The 1994-96, 98 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods “as consumed” (e.g., apple pie) are linked to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events.  Based on analysis of the 1994-96, 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate.  The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure.  Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population subgroup.

  SEQ CHAPTER \h \r 1 V.  Toxicological Information

Fomesafen has low acute toxicity by the oral route of exposure. It is severely irritating to the eye and is a moderate skin irritant. In the subchronic and chronic feeding studies, the consistent finding is the effect in the liver characterized by increases in liver weight and in associated enzymes including alkaline phosphatase, alanine transaminase, and aspartate transaminase. Hyalinization of the liver is also observed.  Currently, the toxicity database is adequate in establishing the toxicity endpoints for risk assessment.  No toxicity studies have been received since the last human health risk assessment (A. LaMay, D373963 2/19/2010).  In accordance with the EPA Final Guidelines for Carcinogen Risk Assessment (March 29, 2005), the CARC classified fomesafen as “Not Likely to be Carcinogenic to Humans.”  This decision was based on the weight-of-evidence which supports activation of peroxisome proliferator activated receptor alpha (PPARα) as the mode of action for fomesafen-induced hepatocarcinogenesis in mice.  The quantification of cancer risk is not required.  A summary of the endpoints selected for dietary risk assessment may be found in Table 1 below.

Table 1.  Summary of Toxicological Doses and Endpoints for Fomesafen for Use in Dietary Exposure Risk Assessments

Exposure/

Scenario	Point of Departure	Uncertainty/FQPA Safety Factors	RfD, PAD, Level of Concern 	Study and Toxicological Effects

Acute Dietary 	No toxic affects attributable to a single dose of fomesafen were found in any study.

Chronic Dietary (All Populations)	NOAEL= 0.25 mg/kg/day	UFA= 10x

UFH= 10x

FQPA SF= 1x

	Chronic RfD = 0.0025 mg/kg/day

cPAD = 0.0025 mg/kg/day	Chronic toxicity - rat

LOAEL = 5 mg/kg/day based on hyalinization of the liver in males

Cancer (oral, dermal, inhalation)   	Classification: “Not likely to be Carcinogenic to Humans”

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 (intraspecies).  UFH = potential variation in sensitivity among members of the human population (interspecies).  FQPA SF = FQPA Safety Factor.  PAD = population adjusted dose (a = acute, c = chronic).  RfD = reference dose.

  SEQ CHAPTER \h \r 1 VI.  Results/Discussion

xceeds 100% of the PAD.  The DEEM-FCID™ analysis estimates the dietary exposure of the U.S. population and various population subgroups.  The results summarized in Table 2 are for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years.

  SEQ CHAPTER \h \r 1 Results of Chronic Dietary Exposure Analysis

The chronic assessments estimate the dietary exposure of the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.  All risk estimates are below the level of concern for all population subgroups assessed for food and drinking water exposures.  The exposure for food plus drinking water to the general U.S. population is 12% of the cPAD.  When considering food alone, the highest exposure is for children ages 1-2, at 0.000207 mg/kg/day, which represents 8.3% of the cPAD.  However, the population subgroup with the highest exposure when considering both food and drinking water and risk estimates is all infants.  The exposure for food plus drinking water was 0.000813 mg/kg/day, which utilized 32% of the cPAD.  The results of the chronic dietary analyses are reported in Table 2 below.

Table 2.  Summary of Chronic Dietary (Food and Drinking Water) Exposure and Risk for Fomesafen

Population Subgroup	Food Alone	Food and Drinking Water2

	Dietary Exposure (mg/kg/day)	% cPAD1	Dietary Exposure

(mg/kg/day)	% cPAD1

General U.S. Population	0.000086	3.4	0.000308	12

All Infants (< 1 year old)	0.000085	3.4	0.000813	32

Children 1-2 years old	0.000207	8.3	0.000536	22

Children 3-5 years old	0.000184	7.3	0.000492	20

Children 6-12 years old	0.000124	4.9	0.000336	14

Youth 13-19 years old	0.000086	3.4	0.000247	9.9

Adults 20-49 years old	0.000073	2.9	0.000280	11

Adults 50+ years old	0.000063	2.5	0.000281	11

Females 13-49 years old	0.000068	2.7	0.000275	11

  SEQ CHAPTER \h \r 1 1 The values for the population with the highest exposure for each type of risk assessment are bolded.

2 The estimated drinking water concentration used in this analysis is from the PRZM-EXAMS modeling of surface water of the MS cotton scenario.

  SEQ CHAPTER \h \r 1 VII.	Conclusions

An unrefined chronic dietary exposure assessment was performed for fomesafen sodium.  The assumptions of these dietary exposure assessments were tolerance level residues and 100% crop treated.  The dietary-exposure analyses in this assessment for fomesafen result in dietary risk for food and water estimates that are below the Agency’s level of concern for chronic dietary exposure.  When considering exposure to fomesafen in food and drinking water the highest exposure and risk estimates were for infants, whose exposure is at 32% of the cPAD.

  SEQ CHAPTER \h \r 1 VIII.	List of Attachments

Attachment 1:  DEEM-FCID™ Chronic Food plus Surface Water Residue Input file.

Attachment 2:  DEEM-FCID™ Chronic Food Alone Results file.

Attachment 3:  DEEM-FCID™ Chronic Food plus Surface Water Results file.

.Attachment 1:  DEEM-FCID™ Chronic Food plus Surface Water Residue Input

	file.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for FOMESAFEN                          1994-98 data

Residue file: C:\Documents and Settings\ALEMAY\My Documents\Fomesafen- peanuts peppers\Dietary Assessment\Old dietary\Fomesafen_Chronic_Pepper_foodandwater.R98

                                                           Adjust. #2 NOT used

Analysis Date 05-18-2010             Residue file dated: 05-18-2010/09:52:53/8

Reference dose (RfD) = 0.0025 mg/kg bw/day

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

Food Crop                                       Residue       Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)

                                                             #1         #2

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

06030300 6C   Bean, black, seed                  0.025000   1.000      1.000

06030320 6C   Bean, broad, seed                  0.025000   1.000      1.000

06030340 6C   Bean, cowpea, seed                 0.025000   1.000      1.000

06030350 6C   Bean,  great northern, seed        0.025000   1.000      1.000

06030360 6C   Bean, kidney, seed                 0.025000   1.000      1.000

06030380 6C   Bean, lima, seed                   0.025000   1.000      1.000

06030390 6C   Bean, mung, seed                   0.025000   1.000      1.000

06030400 6C   Bean, navy, seed                   0.025000   1.000      1.000

06030410 6C   Bean, pink, seed                   0.025000   1.000      1.000

06030420 6C   Bean, pinto, seed                  0.025000   1.000      1.000

06010430 6A   Bean, snap, succulent              0.025000   1.000      1.000

06010431 6A   Bean, snap, succulent-babyfood     0.025000   1.000      1.000

06030980 6C   Chickpea, seed                     0.025000   1.000      1.000

06030981 6C   Chickpea, seed-babyfood            0.025000   1.000      1.000

06030990 6C   Chickpea, flour                    0.025000   1.000      1.000

95001280 O    Cottonseed, oil                    0.025000   1.000      1.000

95001281 O    Cottonseed, oil-babyfood           0.025000   1.000      1.000

06031820 6C   Guar, seed                         0.025000   1.000      1.000

06031821 6C   Guar, seed-babyfood                0.025000   1.000      1.000

06032030 6C   Lentil, seed                       0.025000   1.000      1.000

06032560 6C   Pea, dry                           0.025000   1.000      1.000

06032561 6C   Pea, dry-babyfood                  0.025000   1.000      1.000

06032580 6C   Pea, pigeon, seed                  0.025000   1.000      1.000

08002700 8    Pepper, bell                       0.025000   1.000      1.000

08002701 8    Pepper, bell-babyfood              0.025000   1.000      1.000

08002710 8    Pepper, bell, dried                0.025000   1.000      1.000

08002711 8    Pepper, bell, dried-babyfood       0.025000   1.000      1.000

08002720 8    Pepper, nonbell                    0.025000   1.000      1.000

08002721 8    Pepper, nonbell-babyfood           0.025000   1.000      1.000

08002730 8    Pepper, nonbell, dried             0.025000   1.000      1.000

01032960 1C   Potato, chips                      0.025000   1.000      1.000

01032970 1C   Potato, dry (granules/ flakes)     0.025000   6.500      1.000

01032971 1C   Potato, dry (granules/ flakes)-b   0.025000   6.500      1.000

01032980 1C   Potato, flour                      0.025000   6.500      1.000

01032981 1C   Potato, flour-babyfood             0.025000   6.500      1.000

01032990 1C   Potato, tuber, w/peel              0.025000   1.000      1.000

01032991 1C   Potato, tuber, w/peel-babyfood     0.025000   1.000      1.000

01033000 1C   Potato, tuber, w/o peel            0.025000   1.000      1.000

01033001 1C   Potato, tuber, w/o peel-babyfood   0.025000   1.000      1.000

06003470 6    Soybean, seed                      0.020000   1.000      1.000

06003480 6    Soybean, flour                     0.020000   1.000      1.000

06003481 6    Soybean, flour-babyfood            0.020000   1.000      1.000

06003490 6    Soybean, soy milk                  0.020000   1.000      1.000

06003491 6    Soybean, soy milk-babyfood or in   0.020000   1.000      1.000

06003500 6    Soybean, oil                       0.020000   1.000      1.000

06003501 6    Soybean, oil-babyfood              0.020000   1.000      1.000

08003750 8    Tomato                             0.025000   1.000      1.000

08003751 8    Tomato-babyfood                    0.025000   1.000      1.000

08003760 8    Tomato, paste                      0.025000   5.400      1.000

08003761 8    Tomato, paste-babyfood             0.025000   5.400      1.000

08003770 8    Tomato, puree                      0.025000   3.300      1.000

08003771 8    Tomato, puree-babyfood             0.025000   3.300      1.000

08003780 8    Tomato, dried                      0.025000  14.300      1.000

08003781 8    Tomato, dried-babyfood             0.025000  14.300      1.000

08003790 8    Tomato, juice                      0.025000   1.500      1.000

86010000 O    Water, direct, all sources         0.010535   1.000      1.000

86020000 O    Water, indirect, all sources       0.010535   1.000      1.000

Attachment 2:  DEEM-FCID™ Chronic Food Alone Results file.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for FOMESAFEN                        (1994-98 data)

Residue file name: C:\Documents and Settings\ALEMAY\My Documents\Fomesafen- peanuts peppers\Dietary Assessment\Old dietary\Fomesafen_Chronic_Pepper_foodonly.R98

                                                 Adjustment factor #2 NOT used.

Analysis Date 05-18-2010/09:55:11     Residue file dated: 05-18-2010/09:51:41/8

Reference dose (RfD, Chronic) = .0025 mg/kg bw/day

======================================================================== =======

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.000086                 3.4%

U.S. Population (spring season)             0.000085                 3.4%

U.S. Population (summer season)             0.000085                 3.4%

U.S. Population (autumn season)             0.000087                 3.5%

U.S. Population (winter season)             0.000088                 3.5%

Northeast region                            0.000083                 3.3%

Midwest region                              0.000091                 3.6%

Southern region                             0.000085                 3.4%

Western region                              0.000086                 3.5%

Hispanics                                   0.000100                 4.0%

Non-hispanic whites                         0.000084                 3.4%

Non-hispanic blacks                         0.000084                 3.4%

Non-hisp/non-white/non-black                0.000088                 3.5%

All infants (< 1 year)                      0.000085                 3.4%

Nursing infants                             0.000034                 1.4%

Non-nursing infants                         0.000104                 4.1%

Children 1-6  yrs                           0.000187                 7.5%

Children 7-12 yrs                           0.000117                 4.7%

Females 13-19 (not preg or nursing)         0.000081                 3.2%

Females 20+ (not preg or nursing)           0.000063                 2.5%

Females 13-50 yrs                           0.000074                 3.0%

Females 13+ (preg/not nursing)              0.000073                 2.9%

Females 13+ (nursing)                       0.000071                 2.8%

Males 13-19 yrs                             0.000092                 3.7%

Males 20+ yrs                               0.000075                 3.0%

Seniors 55+                                 0.000062                 2.5%

Children 1-2 yrs                            0.000207                 8.3%

Children 3-5 yrs                            0.000184                 7.3%

Children 6-12 yrs                           0.000124                 4.9%

Youth 13-19 yrs                             0.000086                 3.4%

Adults 20-49 yrs                            0.000073                 2.9%

Adults 50+ yrs                              0.000063                 2.5%

Females 13-49 yrs     †††††††††††⸰〰〰㠶††††††††㈠ 㜮ഥⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭ ⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭഭ

Attachment 3:  DEEM-FCID™ Chronic Food plus Surface Water Results file.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for FOMESAFEN                        (1994-98 data)

Residue file name: C:\Documents and Settings\ALEMAY\My Documents\Fomesafen- peanuts peppers\Dietary Assessment\Old dietary\Fomesafen_Chronic_Pepper_foodandwater.R98

                                                 Adjustment factor #2 NOT used.

Analysis Date 05-18-2010/09:57:09     Residue file dated: 05-18-2010/09:52:53/8

Reference dose (RfD, Chronic) = .0025 mg/kg bw/day

======================================================================== =======

                    Total exposure by population subgroup

,

5

‡

ˆ

™

«

´

¹

¼

Ö

ö

÷

ÿ

J

L

M

a

b

s

6

h

Š

Œ

”

—

º

×

ù

ú

@

K

L

t

u

@

@

  hÂ

  hÂ

 hÂ

@

  hÂ

  hÂ

&

&

&

&

&

&

&

&

&

摧ನ Ê欀ⵤ

&

&

摧ನ Ê欀⽤

&

&

&

&

&

@

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.000308                12.3%

U.S. Population (spring season)             0.000305                12.2%

U.S. Population (summer season)             0.000324                13.0%

U.S. Population (autumn season)             0.000302                12.1%

U.S. Population (winter season)             0.000303                12.1%

Northeast region                            0.000285                11.4%

Midwest region                              0.000315                12.6%

Southern region                             0.000296                11.8%

Western region                              0.000341                13.6%

Hispanics                                   0.000352                14.1%

Non-hispanic whites                         0.000301                12.0%

Non-hispanic blacks                         0.000295                11.8%

Non-hisp/non-white/non-black                0.000360                14.4%

All infants (< 1 year)                      0.000813                32.5%

Nursing infants                             0.000304                12.2%

Non-nursing infants                         0.001005                40.2%

Children 1-6  yrs                           0.000498                19.9%

Children 7-12 yrs                           0.000319                12.7%

Females 13-19 (not preg or nursing)         0.000237                 9.5%

Females 20+ (not preg or nursing)           0.000285                11.4%

Females 13-50 yrs                           0.000289                11.6%

Females 13+ (preg/not nursing)              0.000289                11.5%

Females 13+ (nursing)                       0.000378                15.1%

Males 13-19 yrs                             0.000255                10.2%

Males 20+ yrs                               0.000274                10.9%

Seniors 55+                                 0.000280                11.2%

Children 1-2 yrs                            0.000536                21.5%

Children 3-5 yrs                            0.000492                19.7%

Children 6-12 yrs                           0.000336                13.5%

Youth 13-19 yrs                             0.000247                 9.9%

Adults 20-49 yrs                            0.000280                11.2%

Adults 50+ yrs                              0.000281                11.2%

Females 13-49 yrs                           0.000275                11.0%

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

 PAGE

Fomesafen Sodium	Dietary Exposure Assessment	DP Number: D382064

PC Code: 123802	                                                                               Page   PAGE  1  of   NUMPAGES  11

 PAGE   8

Fomesafen Sodium	Dietary Exposure Assessment	DP Barcode: D??????

PC Code: 123802	                                                          Page      of  11


[Federal Register Volume 88, Number 227 (Tuesday, November 28, 2023)]
[Rules and Regulations]
[Pages 83036-83039]
[FR Doc No: 2023-26022]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R02-OAR-2023-0252; FRL-11034-02-R2]

Approval of Air Quality Implementation Plans; New Jersey;
Exemptions To Improve Resiliency, Air Toxics Thresholds, PM2.5 and
Ammonia Emission Statement Reporting, and PM2.5 in Air Permitting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving
adoptions, repeals, and amendments to the New Jersey State
Implementation Plan (SIP) concerning exemptions to improve resiliency
during emergency situations, updates to hazardous air pollutant (HAP)
reporting thresholds, updates to the certification and submission of
emission statements, and the addition of Federal New Source Review
(NSR) requirements for fine particles (PM2.5). The intended
effect of New Jersey's revisions are to enable government and business
entities to be more resilient during and following disruptions from
natural and human-caused disasters; update HAP unit risk factors and
reference concentrations to reflect current research, scientific, and
technological advancements; update provisions to require the reporting
of PM2.5 and ammonia (NH3) emissions at the source level and
update the electronic reporting of emission statements to adapt with
advancements and Federal requirements; and conform the State's rules on
air permits to the EPA's NSR requirements for PM2.5 to
ensure a source does not adversely impact the EPA-established National
Ambient Air Quality Standards (NAAQS). Other revisions New Jersey made,
which the EPA is approving with this notice of final rulemaking, will
conform administrative penalties to the approved rules and correct
errors and inconsistencies throughout the State's SIP. This action is
being taken in accordance with the requirements of the Clean Air Act.
The EPA proposed to approve this rule on September 28, 2023, and
received no comments.

DATES: This final rule is effective on December 28, 2023.

ADDRESSES: The EPA has established a docket for this action under
Docket ID Number EPA-R02-OAR-2023-0252. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g., Controlled
Unclassified Information (CUI) (formally referred to as Confidential
Business Information (CBI)) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available electronically through https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Nicholas Ferreira, Air Programs
Branch, Environmental Protection Agency, Region 2, 290 Broadway, 25th
Floor, New York, New York 10007-1866,<PHONE_NUMBER>, or by email at
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. What is the background for this action?
II. Environmental Justice Considerations
III. What comments were received in response to the EPA's proposed
action?
IV. What action is the EPA taking?
V. Incorporation by Reference
VI. Statutory and Executive Order Reviews

I. What is the background for this action?

    On September 28, 2023 (88 FR 66733), the EPA published a Notice of
Proposed Rulemaking that proposed to approve State Implementation Plan
(SIP) revisions submitted by the State of New Jersey on December 14,
2017, and August 23, 2018, for the purpose of approving new rules,
repeals, and amendments to subchapter 8, subchapter 16, subchapter 17,
subchapter 18, subchapter 19, and subchapter 21 of New Jersey
Administrative Code, Title 7, Chapter 27 (N.J.A.C. 7:27); as well as to
subchapter 3 of N.J.A.C., Title 7, Chapter 27A.
    New Jersey's revisions to N.J.A.C. 7:27 implement changes based on
the experience the State has gained in response to disruptions caused
by natural disasters such as Superstorm Sandy and discussions that the
State has held with representatives of the regulated community and
environmental groups. New Jersey's revisions include exemptions from
air emission control and permitting requirements that will provide
flexibility for facilities to use low-emitting temporary and portable
equipment to improve resiliency during emergency situations.
    Additionally, New Jersey's revisions update HAP reporting
thresholds using the most recent science-based methodologies; amend the
rules governing emissions statements to require each facility to report
criteria pollutants and precursors (including PM2.5 and
ammonia) at the source level; revise the rules governing certification
and electronic submittal of emissions statements; revise the New Source
Review (NSR) requirements to implement the National Ambient Air Quality
Standards (NAAQS) for fine particles (PM2.5); and modify
penalty provisions to provide consistency with the State's revisions
finalized for approval within this notice. For the reasons herein
stated, the EPA is approving the revisions made by New Jersey to
strengthen the effectiveness of the State's SIP.
    The specific details of New Jersey's SIP submittals and the
rationale for the EPA's approval action are explained in the EPA's
proposed rulemaking and are not restated in this final action. For this
detailed information, the reader is referred to the EPA's September 28,
2023, proposed rulemaking (88 FR 66733).

II. Environmental Justice Considerations

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to review State choices,
and approve those choices if they meet the minimum criteria of the Act.
    The specific details of New Jersey's Environmental Justice (EJ)
considerations are explained in the EPA's proposed rulemaking and are
not restated in this final action. For this detailed information, the
reader is referred to the EPA's September 28, 2023, proposed rulemaking
(88 FR 66733).
    Furthermore, as the EPA stated in the proposed rulemaking, although
New Jersey included EJ considerations as part of its SIP submittal, the
CAA and applicable implementing regulations neither prohibit nor
require such an evaluation. New Jersey's provisions being approved by
the EPA within this notice address statewide matters, and since EJ
issues are more accurately captured when evaluating relatively smaller
areas or on a community level basis, the EPA determined it would not
have been appropriate to evaluate EJ concerns at a statewide level.
    The EPA expects that this final action will be neutral or
contribute to reduced environmental and health impacts on all
populations in New Jersey, including people of color and low-income
populations in New Jersey. At a minimum, this final action is not
expected to worsen any air quality and it is expected this action will
ensure the State is meeting requirements to attain and/or maintain air
quality standards. The EPA therefore concludes that this final action
will not have or lead to disproportionately high or adverse human
health or environmental effects on communities with EJ concerns.

III. What comments were received in response to the EPA's proposed
action?

    The EPA provided a 30-day review and comment period for the
September 28, 2023, proposed rule. The comment period ended on October
30, 2023. The EPA received no comments on this action; therefore, the
EPA is finalizing action as proposed.

IV. What action is the EPA taking?

    The EPA is approving New Jersey's revisions to N.J.A.C. 7:27
subchapter 8, ``Permits and Certificates for Minor Facilities (and
Major Facilities without an Operating Permit),'' section 8.1,
``Definitions;'' and subchapter 21, ``Emission Statements,'' submitted
to EPA on December 14, 2017 (State effective November 6, 2017), and as
further updated in a SIP revision to EPA on August 23, 2018 (State
effective January 16, 2018).
    The EPA is also approving New Jersey's revisions to N.J.A.C. 7:27
subchapter 18, ``Control and Prohibition of Air Pollution from New or
Altered Sources Affecting Ambient Air Quality (Emission Offset
Rules),'' submitted to EPA on December 14, 2017 (State effective
November 6, 2017).
    In addition, the EPA is approving the State's revisions to N.J.A.C.
7:27 subchapter 16, ``Control and Prohibition of Air Pollution by
Volatile Organic Compounds;'' subchapter 17, ``Control and Prohibition
of Air Pollution by Toxic Substances;'' subchapter 19, ``Control and
Prohibition of Air Pollution by Oxides of Nitrogen;'' and Chapter 27A,
subchapter 3.10, ``Civil Administrative Penalties for Violations of
Rules Adopted Pursuant to the Act,'' submitted to EPA on August 23,
2018 (State effective January 16, 2018).

V. Incorporation by Reference

    In this document, the EPA is finalizing regulatory text that
includes incorporation by reference. In accordance with requirements of
1 CFR 51.5, the EPA is finalizing the incorporation by reference
revisions to N.J.A.C. 7:27 subchapter 8, ``Permits and Certificates for
Minor Facilities (and Major Facilities without an Operating Permit),''
section 8.1, ``Definitions;'' subchapter 16, ``Control and Prohibition
of Air Pollution by Volatile Organic Compounds;'' subchapter 17,
``Control and Prohibition of Air Pollution by Toxic Substances;''
subchapter 18, ``Control and Prohibition of Air Pollution from New or
Altered Sources Affecting Ambient Air Quality (Emission Offset
Rules);'' subchapter 19, ``Control and Prohibition of Air Pollution by
Oxides of Nitrogen;'' subchapter 21, ``Emission Statements;'' and
Chapter 27A, subchapter 3.10, ``Civil Administrative Penalties for
Violations of Rules Adopted Pursuant to the Act,'' as discussed in
Section I. of this preamble. The EPA has made, and will continue to
make, these materials generally available through www.regulations.gov
and at the EPA Region 2 Office (please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section of this preamble for more
information). Therefore, these materials have been approved by the EPA
for inclusion in the State Implementation Plan, have been incorporated
by reference by the EPA into that plan, are fully federally enforceable
under sections 110 and 113 of the CAA as of the effective date of the
final rulemaking of the EPA's approval, and will be incorporated by
reference in the next update to the SIP compilation.\1\
---------------------------------------------------------------------------

    \1\ 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

VI. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act 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 Clean Air Act.
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 Orders 12866 (58
FR 51735, October 4, 1993) and 14094 (88 FR 21879, April 11, 2023);
     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 subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because it approves a State program;
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001); and
     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 Clean Air Act.
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian Tribe
has demonstrated that a Tribe has jurisdiction. In those areas of
Indian country, the rule does not have Tribal implications and it will
not

impose substantial direct costs on Tribal governments or preempt Tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).
    Executive Order 12898 (Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations, 59 FR 7629,
February 16, 1994) directs Federal agencies to identify and address
``disproportionately high and adverse human health or environmental
effects'' of their actions on minority populations and low-income
populations to the greatest extent practicable and permitted by law.
EPA defines environmental justice (EJ) as ``the fair treatment and
meaningful involvement of all people regardless of race, color,
national origin, or income with respect to the development,
implementation, and enforcement of environmental laws, regulations, and
policies.'' EPA further defines the term fair treatment to mean that
``no group of people should bear a disproportionate burden of
environmental harms and risks, including those resulting from the
negative environmental consequences of industrial, governmental, and
commercial operations or programs and policies.''
    The NJDEP evaluated EJ as part of its SIP submittal even though the
CAA and applicable implementing regulations neither prohibit nor
require an evaluation. The EPA's evaluation of the NJDEP's EJ
considerations is described in detail under the section titled,
``Environmental Justice Considerations,'' within the September 28,
2023, Notice of Proposed Rulemaking (88 FR 66733). The analysis was
done for the purpose of providing additional context and information
about this rulemaking to the public, not as a basis of the action. The
EPA is taking action under the CAA on bases independent of New Jersey's
evaluation of EJ. Due to the nature of the action being taken here,
this action is expected to have a neutral to positive impact on the air
quality of the affected area. In addition, there is no information in
the record upon which this decision is based that is inconsistent with
the stated goal of E.O. 12898 of achieving environmental justice for
people of color, low-income populations, and Indigenous peoples.
    This action is subject to the Congressional Review Act, and the EPA
will submit a rule report to each House of the Congress and the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by January 29, 2024. 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. 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, Ammonia,
Incorporation by reference, Intergovernmental relations, Nitrogen
Oxides, Particulate matter, Reporting and recordkeeping requirements,
Sulfur dioxide, Volatile organic compounds.

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

Lisa Garcia,
Regional Administrator, Region 2.
    For the reasons set forth in the preamble, 40 CFR part 52 is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart FF--New Jersey

0
2. In Sec.  52.1570, the table in paragraph (c) is amended by:
0
a. Removing the entry for ``Title 7, Chapter 27, Section 8.1 and 8.2'';
0
b. Adding entries for ``Title 7, Chapter 27, Section 8.1'' and ``Title
7, Chapter 27, Section 8.2'' in numerical order after the entry Title
7, Chapter 27, Subchapter 8; and
0
c. Revising the entries for ``Title 7, Chapter 27, Subchapter 16'',
``Title 7, Chapter 27, Subchapter 17'', ``Title 7, Chapter 27,
Subchapter 18'', ``Title 7, Chapter 27, Subchapter 19'', ``Title 7,
Chapter 27, Subchapter 21'', and ``Title 7, Chapter 27A, Subchapter
3.10''.
    The revisions and additions read as follows:

Sec.  52.1570  Identification of plan.

* * * * *
    (c) * * *

                               EPA-Approved New Jersey State Regulations and Laws
----------------------------------------------------------------------------------------------------------------
                                                     State effective
         State citation            Title/subject           date        EPA approval date         Comments
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Title 7, Chapter 27, Section     Definitions......  January 16, 2018.  11/28/2023.......   EPA approval
 8.1.                                                                                finalized at [insert
                                                                                Federal Register
                                                                                citation].
Title 7, Chapter 27, Section     Applicability....  June 20, 1994....  August 7, 1997,    ......................
 8.2.                                                                   62 FR 42412.

                                                  * * * * * * *
Title 7, Chapter 27, Subchapter  Control and        January 16, 2018.  11/28/2023.......   EPA approval
 16.                              Prohibition of                                           finalized at [insert
                                  Air Pollution by                                         Federal Register
                                  Volatile Organic                                         citation].
                                  Compounds.
Title 7, Chapter 27, Subchapter  Control and        January 16, 2018.  11/28/2023.......   EPA approval
 17.                              Prohibition of                                           finalized at [insert
                                  Air Pollution by                                         Federal Register
                                  Toxic Substances.                                        citation].

Title 7, Chapter 27, Subchapter  Control and        November 6, 2017.  11/28/2023.......   EPA approval
 18.                              Prohibition of                                           finalized at [insert
                                  Air Pollution                                            Federal Register
                                  from New or                                              citation].
                                  Altered Sources
                                  Affecting
                                  Ambient Air
                                  Quality
                                  (Emission Offset
                                  Rules).
Title 7, Chapter 27, Subchapter  Control and        January 16, 2018.  11/28/2023.......   EPA approval
 19.                              Prohibition of                                           finalized at [insert
                                  Air Pollution by                                         Federal Register
                                  Oxides of                                                citation].
                                  Nitrogen.                                                Subchapter 19
                                                                                is approved into the
                                                                                SIP except for the
                                                                                following provisions:
                                                                                (1) Phased compliance
                                                                                plan through
                                                                                repowering in Section
                                                                                19.21 that allows for
                                                                                implementation beyond
                                                                                May 1, 1999; and (2)
                                                                                phased compliance
                                                                                plan through the use
                                                                                of innovative control
                                                                                technology in Section
                                                                                19.23 that allows for
                                                                                implementation beyond
                                                                                May 1, 1999.
Title 7, Chapter 27, Subchapter  Emission           January 16, 2018.  11/28/2023.......   EPA approval
 21.                              Statements.                                              finalized at [insert
                                                                                Federal Register
                                                                                citation].
                                                                                Section 7:27-
                                                                                21.3(b)(1) and 7:27-
                                                                                21.3(b)(2) of New
                                                                                Jersey's Emission
                                                                                Statement rule
                                                                                requires facilities
                                                                                to report on the
                                                                                following pollutants
                                                                                to assist the State
                                                                                in air quality
                                                                                planning needs:
                                                                                Hydrochloric acid,
                                                                                hydrazine, methylene
                                                                                chloride,
                                                                                tetrachloroethylene,
                                                                                1, 1, 1
                                                                                trichloroethane,
                                                                                carbon dioxide and
                                                                                methane. EPA will not
                                                                                take SIP-related
                                                                                enforcement action on
                                                                                these pollutants.

                                                  * * * * * * *
Title 7, Chapter 27A,            Civil              January 16, 2018.  11/28/2023.......   EPA approval
 Subchapter 3.10.                 Administrative                                           finalized at [insert
                                  Penalties for                                            Federal Register
                                  Violations of                                            citation].
                                  Rules Adopted
                                  Pursuant to the
                                  Act.

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

* * * * *
[FR Doc. 2023-26022 Filed 11-27-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: June 6, 2008 (Volume 73, Number 110)]
[Notices]
[Page 32377]
[DOCID:fr06jn08-129]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56145A; File No. SR-NASD-2007-023

Self-Regulatory Organizations; National Association of Securities
Dealers, Inc. (n/k/a Financial Industry Regulatory Authority, Inc.);
Order Approving Proposed Rule Change To Amend the By-Laws of NASD To
Implement Governance and Related Changes To Accommodate the
Consolidation of the Member Firm Regulatory Functions of NASD and NYSE
Regulation, Inc.

May 30, 2008.

Amended

    In Part V of Securities Exchange Act Release No. 56145 (``Release
No. 34-56145''), issued July 26, 2007,\1\ the Securities and Exchange
Commission (``Commission'') is adding, immediately after the following
sentence:
---------------------------------------------------------------------------

    \1\ See Securities Exchange Act Release No. 56145 (July 26,
2007), 72 FR 42169 (August 1, 2007) (FR Doc. E7-14855).

    Accordingly, after reviewing the record in this matter, the
Commission believes that NASD has provided sufficient basis on which
the Commission can find that, under the Exchange Act, NASD complied
with its Certificate of Incorporation and By-Laws with respect to
the proxy approval process and that the proposed amendments to its
---------------------------------------------------------------------------
By-Laws were properly approved by NASD members.

the following paragraph:

    This finding as to NASD compliance and members'' approval is not
a definitive adjudication under state law, such as a trial court
would make after an evidentiary hearing, regarding the claim that
the proxy statement was misleading. Except to the extent that state
law informs the Commission's finding that, as a federal matter under
the Exchange Act, NASD complied with its Certificate of
Incorporation and By-Laws with respect to the proxy approval process
and that the proposed amendments to its By-Laws were properly
approved by NASD members, the Commission is not purporting to decide
a question of state law. The Commission does not intend that its
determination regarding the NASD's uncontradicted prima facie
showing before the Commission that the proxy statement was not
misleading be binding on a court in a claim based on state law.

    In adding this clarifying language, the Commission is not vacating,
nullifying or rendering void Release No. 34-56145, which approved
NASD's proposed rule change to amend the By-Laws of NASD to implement
governance and related changes to accommodate the consolidation of the
member firm regulatory functions of NASD and NYSE Regulation, Inc.
Release No. 34-56145, as amended herein, remains in effect as of July
26, 2007, the date it was issued by the Commission.

    By the Commission.
Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-12631 Filed 6-5-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 81, Number 135 (Thursday, July 14, 2016)]
[Rules and Regulations]
[Pages 45419-45421]
[FR Doc No: 2016-16449]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2015-0839; FRL-9948-93-Region 4]

Determination of Attainment; Atlanta, Georgia; 2008 Ozone
National Ambient Air Quality Standards

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to determine that the Atlanta, Georgia, 2008 Ozone National
Ambient Air Quality Standard (NAAQS) Moderate Nonattainment Area
(``Atlanta Area'' or the ``Area'') has attained the 2008 8-hour ozone
NAAQS. This final determination is based upon complete, quality-
assured, and certified ambient air monitoring data showing that the
Area has monitored attainment of the 2008 8-hour ozone NAAQS for the
2013-2015 monitoring period. The requirement for this Area to submit an
attainment demonstration and associated reasonably available control
measures (RACM), reasonable further progress (RFP) plans, contingency
measures, and other planning state implementation plans (SIPs) related
to attainment of the 2008 8-hour ozone NAAQS is suspended until EPA
redesignates the Area to attainment, approves a redesignation
substitute, or determines that the Area has violated the 2008 8-hour
ozone NAAQS. This final attainment determination does not constitute a
redesignation to attainment. The Atlanta Area will remain in
nonattainment status for the 2008 8-hour ozone NAAQS until such time as
the State requests a redesignation to attainment and EPA determines
that the Atlanta Area meets the Clean Air Act (CAA or Act) requirements
for redesignation, including an approved maintenance plan.

DATES: This rule will be effective August 15, 2016.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2015-0839. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday 8:30 a.m. to 4:30 p.m.,
excluding federal holidays.

FOR FURTHER INFORMATION CONTACT: Jane Spann, Air Regulatory Management
Section, Air Planning and Implementation Branch, Air, Pesticides and
Toxics Management Division, Region 4, U.S. Environmental Protection
Agency, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Ms. Spann
can be reached via phone at<PHONE_NUMBER> or via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On March 12, 2008, EPA revised both the primary and secondary NAAQS
for ozone to a level of 0.075 parts per million (ppm) (annual fourth-
highest daily maximum 8-hour average concentration, averaged over three
years) to provide increased protection of public health and the
environment. See 73 FR 16436 (March 27, 2008). The 2008 ozone NAAQS
retains the same general form and averaging time as the 0.08 ppm NAAQS
set in 1997, but is set at a more protective level.

    Effective July 20, 2012, EPA designated any area that was violating
the 2008 8-hour ozone NAAQS based on the three most recent years (2008-
2010) of air monitoring data as a nonattainment area. See 77 FR 30088
(May 21, 2012). The Atlanta Area, consisting of Bartow, Cherokee,
Clayton, Cobb, Coweta, DeKalb, Douglas, Fayette, Forsyth, Fulton,
Gwinnett, Henry, Newton, Paulding, and Rockdale counties, was
designated as a marginal ozone nonattainment area. See 40 CFR 81.311.
Areas that were designated as marginal ozone nonattainment areas were
required to attain the 2008 8-hour ozone NAAQS no later than July 20,
2015, based on 2012-2014 monitoring data. The Atlanta Area did not
attain the 2008 8-hour ozone NAAQS by July 20, 2015, and therefore on
April 11, 2016, the EPA Administrator signed a final rule reclassifying
the Atlanta Area from a marginal nonattainment area to a moderate
nonattainment area for the 2008 8-hour ozone standard. See 81 FR 26697
(May 4, 2016). Moderate areas are required to attain the 2008 8-hour
ozone NAAQS by no later than July 20, 2018, six years after the
effective date of the initial nonattainment designations. See 40 CFR
51.1103. Air quality monitoring data from the 2013-2015 monitoring
period show that the Atlanta Area is now attaining the 2008 8-hour
ozone NAAQS.
    Under the provisions of EPA's ozone implementation rule for the
2008 8-hour ozone NAAQS (40 CFR part 51, subpart AA), if EPA issues a
determination that an area is attaining the relevant standard, also
known as a Clean Data Determination, the area's obligations to submit
an attainment demonstration and associated RACM, RFP, contingency
measures, and other planning SIPs related to attainment of the 2008 8-
hour ozone NAAQS are suspended until EPA: (i) Redesignates the area to
attainment for the standard or approves a redesignation substitute, at
which time those requirements no longer apply; or (ii) EPA determines
that the area has violated the standard, at which time the area is
again required to submit such plans. See 40 CFR 51.1118. While these
requirements are suspended, EPA is not precluded from acting upon these
elements at any time if submitted to EPA for review and approval.
    An attainment determination is not equivalent to a redesignation
under section 107(d)(3) of the CAA. The designation status of the
Atlanta Area will remain nonattainment for the 2008 8-hour ozone NAAQS
until such time as EPA determines that the Area meets the CAA
requirements for redesignation to attainment, including an approved
maintenance plan, and redesignates the Area. Additionally, the
determination of attainment is separate from, and does not influence or
otherwise affect, any future designation determination or requirements
for the Atlanta Area based on any new or revised ozone NAAQS, and the
determination of attainment remains in effect regardless of whether EPA
designates this Area as a nonattainment area for purposes of any new or
revised ozone NAAQS.
    In a notice of proposed rulemaking (NPRM) published on May 3, 2016,
EPA proposed to determine that the Atlanta Area has attained the 2008
8-hour ozone NAAQS. See 81 FR 26515 (May 3, 2016). No comments were
received on the May 3, 2016, proposed rulemaking. The details of
Georgia's submittal and the rationale for EPA's actions are further
explained in the NPRM. See 81 FR 26515 (May 3, 2016).

II. Final Action

    EPA is making the determination that the Atlanta Area has attained
the 2008 8-hour ozone NAAQS. This final determination is based upon
complete, quality assured, and certified ambient air monitoring data
showing that the Atlanta Area has monitored attainment of the 2008 8-
hour ozone NAAQS for the 2013-2015 monitoring period. The requirement
for this Area to submit an attainment demonstration and associated
RACM, a RFP plan, contingency measures, and other planning SIPs related
to attainment of the 2008 8-hour ozone NAAQS are suspended until EPA
redesignates the Area to attainment, approves a redesignation
substitute, or determines that the Area has violated the standard.

III. Statutory and Executive Order Reviews

    This action makes a determination of attainment based on air
quality data 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 Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     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
     will not have disproportionate human health or
environmental effects 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) and
will not impose substantial direct costs on tribal governments or
preempt tribal law because it merely makes a determination based on air
quality data.
    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 12, 2016. 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. 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, Incorporation by
reference, Ozone, Nitrogen dioxide, Volatile organic compounds.

    Dated: June 27, 2016.
Heather McTeer Toney,
Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart L--Georgia

0
2. Section 52.582 is amended by adding paragraph (e) to read as
follows:

Sec.  52.582  Control strategy: Ozone.

* * * * *
    (e) Determination of attaining data. EPA has determined, as of July
14, 2016, that the Atlanta, Georgia nonattainment area has attaining
data for the 2008 8-hour ozone NAAQS. This determination, in accordance
with 40 CFR 51.1118, suspends the requirements for this area to submit
attainment demonstrations and associated reasonably available control
measures, reasonable further progress plans, contingency measures for
failure to attain or make reasonable progress, and other planning SIPs
related to attainment of the 2008 ozone NAAQS, or for any prior NAAQS
for which the determination has been made, until such time as: The area
is redesignated to attainment for that NAAQS or a redesignation
substitute is approved as appropriate, at which time the requirements
no longer apply; or EPA determines that the area has violated that
NAAQS, at which time the area is again required to submit such plans.

[FR Doc. 2016-16449 Filed 7-13-16; 8:45 am]
BILLING CODE 6560-50-P