UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

	OFFICE OF PREVENTION, PESTICIDE

                                                                                AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date:  19/JUN/2008

SUBJECT:	2,6-Dichlorobenzamide (BAM ); 2,6-Dichlorobenzamide (BAM ) as a Metabolite/Degradate of Fluopicolide and Dichlobenil.  Human Health Risk Assessment for Proposed Uses of Rhubarb, Dichlobenil on Caneberries (Subgroup 13-07A), and Bushberries (Subgroup 13-07B).

PC Code:  027401, 027402, 027412	DP Barcode:  354111

Decision No.: 380110	Registration No.: 400-168

Petition No.: 7E7230	Regulatory Action: Section 3 Registration

Risk Assessment Type:  	Case No.:  NA

TXR No.:  NA	CAS No.: 70852-53-8

MRID No.:  NA	40 CFR:  NA

FROM:	Debra Rate, Ph.D., Biologist

		Alternative Risk Integration and Assessment (ARIA) Team

		Risk Integration, Minor Use and Emergency Response Branch (RIMUERB)

		Registration Division (RD) (7505P)

			AND

Mark Dow, Ph.D., Biologist

		ARIA

RIMUERB/RD (7505P)

THROUGH:	Dana Vogel, Branch Chief

Registration Action Branch I (RAB1)

Health Effects Division (HED)(7509P)

TO:		Susan Stanton, Environmental Specialist

		Minor Use Team

RIMUERB/RD (7505P)

In connection with a request for new uses of the active ingredient, dichlobenil, HED/RD of EPA's Office of Pesticide Programs has evaluated the toxicity and exposure databases for 2,6-dichlorobenzamide (BAM) which is a common metabolite/degradate of dichlobenil and fluopicolide.  This assessment summarizes the human health risks from exposure to BAM resulting from the existing and proposed uses of dichlobenil and existing uses of fluopicolide on agricultural commodities, turf, and ornamentals.  A separate human health risk assessment has been completed for fluopicolide residues of concern (DP Num: 325091, F. Fort, 05/MAR/2008) and is concurrently being completed for dichlobenil (DP Num: 341453, D. Rate, 11/JUN/2008).

HED recently completed a Section 3 Human Health risk assessment for BAM as a result of new uses of fluopicolide on tuberous and corm vegetables (except potato), leafy vegetables (except Brassica), fruiting vegetables, cucurbit vegetables, grapes, turf, and ornamentals.  Details of that assessment are contained in the document entitled 2,6-Dichlorobenzamide (BAM ) as a Metabolite/Degradate of Fluopicolide and Dichlobenil.  Human Health Risk Assessment for Proposed Uses of Fluopicolide on Root Vegetables (Subgroup 1A), Leaves of Root and Tuber Vegetables (Group 2), Bulb Vegetables (Group 3), and Head and Stem Brassica (Subgroup 5A) (DP Num: 349864, F. Fort, 19/MAR/2008).  This document is an update to the previous memorandum sited above and changes only those aspects of the BAM risk assessment which are affected by the addition of the new uses of dichlobenil on rhubarb, caneberries (Subgroup 13-07A) and bushberries (Subgroup 13-07B).

Table of Contents

  TOC \o "1-3" \h \z \u    HYPERLINK \l "_Toc198947714"  1.0  Summary of Registered/Proposed Uses	  PAGEREF _Toc198947714 \h  4

  HYPERLINK \l "_Toc198947715"  2.0  Hazard Characterization	  PAGEREF _Toc198947715 \h  4

  HYPERLINK \l "_Toc198947716"  2.1	Hazard Characterization and Endpoint Selection	  PAGEREF _Toc198947716 \h  4

  HYPERLINK \l "_Toc198947717"  2.2	DEREK Analyses for BAM, Fluopicolide, and Dichlobenil	  PAGEREF _Toc198947717 \h  6

  HYPERLINK \l "_Toc198947718"  3.0  Dietary Exposure Assessment	  PAGEREF _Toc198947718 \h  7

  HYPERLINK \l "_Toc198947719"  3.1  Food Residue	  PAGEREF _Toc198947719 \h  7

  HYPERLINK \l "_Toc198947720"  3.2  Drinking Water Estimates	  PAGEREF _Toc198947720 \h  8

  HYPERLINK \l "_Toc198947721"  3.3  Dietary Exposure (Food and Drinking Water)	  PAGEREF _Toc198947721 \h  8

  HYPERLINK \l "_Toc198947722"  4.0  Residential Exposure	  PAGEREF _Toc198947722 \h  9

  HYPERLINK \l "_Toc198947723"  5.0  Aggregate Exposure	  PAGEREF _Toc198947723 \h  11

  HYPERLINK \l "_Toc198947724"  5.1  Acute Aggregate Risk	  PAGEREF _Toc198947724 \h  11

  HYPERLINK \l "_Toc198947725"  5.2  Short- and Intermediate-Term Aggregate Risk	  PAGEREF _Toc198947725 \h  11

  HYPERLINK \l "_Toc198947726"  5.3  Long-Term Aggregate Risk	  PAGEREF _Toc198947726 \h  12

  HYPERLINK \l "_Toc198947727"  6.0  Cumulative Risk Assessments and Risk Characterization	  PAGEREF _Toc198947727 \h  12

  HYPERLINK \l "_Toc198947728"  7.0  Occupational Exposure	  PAGEREF _Toc198947728 \h  13

  HYPERLINK \l "_Toc198947729"  7.1 Handler Exposure and Risk	  PAGEREF _Toc198947729 \h  13

  HYPERLINK \l "_Toc198947730"  7.2  Postapplication Exposure and Risk	  PAGEREF _Toc198947730 \h  15

  HYPERLINK \l "_Toc198947731"  8.0  Data Needs and Label Recommendations	  PAGEREF _Toc198947731 \h  15

  HYPERLINK \l "_Toc198947732"  8.1	Toxicology	  PAGEREF _Toc198947732 \h  15

  HYPERLINK \l "_Toc198947733"  8.2	Residue Chemistry	  PAGEREF _Toc198947733 \h  15

  HYPERLINK \l "_Toc198947734"  8.3	Occupational and Residential Exposure	  PAGEREF _Toc198947734 \h  15

  HYPERLINK \l "_Toc198947735"  9.0  References	  PAGEREF _Toc198947735 \h  15

   HYPERLINK \l "_Toc198947735"  Appendix A:  Toxicity Profile Table	  PAGEREF _Toc198947735 \h  15

1.0  Summary of Registered/Proposed Uses  XE "1.0  Summary of Registered/Proposed Uses"

In connection with Petition No. 7E7230, dichlobenil is being proposed for use on rhubarb, caneberries and bushberries.  Dichlobenil, formulated as the 4% granular product Casoron® 4G (EPA Reg. No. 400-168), is to be applied at a maximum seasonal rate of 2 lb ai/A to rhubarb, 4 lb ai/A to caneberries, and up to 6 lb ai/A to bushberries.  The product is applied directly to soil while the target crop is dormant.

ARIA is presently recommending for the following tolerances for dichlobenil (parent):

Caneberries (Subgroup 13-07A)	0.10 ppm

Bushberries (Subgroup 13-07B)	0.15 ppm

Rhubarb	0.06 ppm

BAM is a common metabolite/degradate of both fluopicolide and dichlobenil.  There are no registered uses for BAM itself.

2.0  Hazard Characterization  XE "2.0  Hazard Characterization "

The hazard assessment for BAM has not changed since the previous assessment; therefore only a brief summary is included in this document.

	2.1	Hazard Characterization and Endpoint Selection  XE "2.1	Hazard Characterization and Endpoint Selection"

The submitted acute and chronic studies on BAM were sufficient to evaluate human hazard potential.  BAM demonstrated moderate acute toxicity (Category III) via the oral route of exposure.  In subchronic and chronic toxicity studies, the primary oral effects seen in the rat and dog were body weight changes.  Adverse liver effects were also observed but at doses of BAM that were higher than those of dichlobenil.  There is no evidence that BAM is either mutagenic or clastogenic nor is there evidence of endocrine mediated toxicity.  BAM is considered to be neurotoxic.  In the absence of carcinogenicity study data for a second species, HED has assumed that BAM’s carcinogenic potential is similar to that of dichlobenil, the parent compound having the greatest carcinogenicity potential.  Dichlobenil is classified as “Group C, possible human carcinogen.  Quantification of cancer risk is based on the reference dose (RfD) approach which requires comparison of the chronic exposure to the RfD.  Using this methodology will adequately account for all chronic toxic effects, including carcinogenicity, likely to result from exposure to dichlobenil and therefore to BAM.  An FQPA SF of 10X for database uncertainty has been retained for the acute and chronic dietary and incidental oral exposure scenarios for incompleteness of the database with regard to the systemic neurotoxic potential of BAM, including olfactory toxicity and also, in the case of acute dietary exposure, use of a LOAEL to extrapolate to a NOAEL.  For the dermal and inhalation routes of exposure, the FQPA SF for BAM toxicity has been reduced to 1X because the effect of concern, olfactory toxicity, was chosen for these exposure scenarios.

A summary of the toxicological endpoints and doses chosen for the relevant exposure scenarios for human risk assessment is found in Table 2.0.

Table 2.0.  Summary of Toxicological Doses and Endpoints for 2,6-Dichlorobenzamide (BAM) for Use in Dietary, Residential, and Occupational Human Health Risk Assessments

Exposure Scenario	Point of Departure	Uncertainty/

FQPA Safety Factors	RfD, PAD, Level of Concern for Risk Assessment	Study and Toxicological Effects

Acute Dietary (General population, including infants and children)	LOAEL = 100 mg/kg/day

	UFA = 10X

UFH = 10X

FQPA SF4,5 = 10X (includes UFL and UFDB)	aRfD = aPAD = 0.1 mg/kg/day Dose-range finding assay for in vivo mouse erythrocyte micronucleus assay LOAEL = 100 mg/kg/day based on lethargy after a single oral dose.

Acute Dietary (Females 13-49 years of age)	NOAEL = 30 mg/kg/day	UFA = 10X

UFH = 10X

FQPA SF4 = 10X

(includes UFDB)	aRfD = aPAD = 0.03 mg/kg/day	Developmental toxicity (rabbit) Offspring LOAEL = 90 mg/kg/day based on increased incidences of  late abortion and skeletal (bipartite interparietal bone) and visceral (postcaval lung lobe agenesis) anomalies.

Chronic Dietary (All populations)	NOAEL = 4.5

mg/kg/day	UFA = 10X

UFH = 10X

FQPA SF4 = 10X

(includes UFDB)	cRfD = cPAD = 0.0045 mg/kg/day	Chronic toxicity (dog) LOAEL = 12.5 mg/kg/day based on decreased body weight and body weight gain.

Incidental Oral

Short- and Intermediate-Term (1-30 days and 1-6 months)	NOAEL = 14

mg/kg/day	UFA = 10X

UFH = 10X

FQPA SF4 = 10X

(includes UFDB)	Residential LOC for MOE = 1000	90-day oral (rat) LOAEL = 49 mg/kg/day based on decreased body weight gain (M) and reduced skeletal muscle tone (day 4 only in males; days 91 and 92 only in females).

Dermal

Short-, Intermediate-, and Long-Term (1-30 days, 1-6 months, and >6 months)	NOAEL = 25

mg/kg/day	UFA = 10X

UFH = 10X

FQPA SF = 1X (residential uses only)	Residential and Occupational LOC for MOE = 100	5-day dermal using dichlobenil6 (mouse; literature study 1) LOAEL = 50 mg/kg/day based on olfactory epithelial damage.

Inhalation

Short-, Intermediate-, and Long-Term (1-30 days, 1-6 months, and >6 months)	NOAEL = 3.1

mg/kg/day 2	UFA = 10X

UFH = 10X

FQPA SF = 1X (residential uses only)	Residential and Occupational LOC for MOE = 100	28-day inhalation using dichlobenil6 (rat) LOAEL = 5.5 mg/kg/day3 based on nasal degeneration.

Cancer	Classification: Formally unclassified; parent herbicide dichlobenil classified as “Group C, possible human carcinogen” with RfD approach utilized for quantification of human risk

Abbreviations: UF = uncertainty factor, UFA = extrapolation from animal to human (interspecies), UFH = potential variation in sensitivity among members of the human population (intraspecies), FQPA SF = FQPA Safety Factor, UFL = use of a LOAEL to extrapolate a NOAEL, UFDB = to account for the absence of key data, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, RfD = reference dose (a = acute, c = chronic), PAD = population adjusted dose, MOE = margin of exposure, LOC = level of concern, N/A = Not Applicable

1   HYPERLINK "http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itoo l=pubmed_Abstract&term=%22Deamer+NJ%22%5BAuthor%5D"  Deamer NJ ,   HYPERLINK "http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itoo l=pubmed_Abstract&term=%22O%27Callaghan+JP%22%5BAuthor%5D"  O'Callaghan JP ,   HYPERLINK "http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itoo l=pubmed_Abstract&term=%22Genter+MB%22%5BAuthor%5D"  Genter MB . (1994). Olfactory toxicity resulting from dermal application of 2,6-dichlorobenzonitrile (dichlobenil) in the C57Bl mouse. Neurotoxicology 15(2):287-93

2 Calculated as follows: [(NOAEL) x (m3 / 1000 L) x (10.26 L / hr) x 6 hr/day x (1 / 0.236 kg)], where NOAEL= 12 mg/m3 from 28-day inhalation toxicity study (Sprague Dawley rat)

3 Calculated as follows: [(LOAEL) x (m3 / 1000 L) x (10.26 L / hr) x 6 hr/day x (1 / 0.236 kg)], where LOAEL= 21 mg/m3 from 28-day inhalation toxicity study (Sprague Dawley rat)

4 The FQPA SF has been retained in the form of a UFDB for the lack of neurotoxicity data, including olfactory toxicity data.

5 The FQPA SF has been retained in the form of a UFL and UFDB for the use of a LOAEL to extrapolate a NOAEL and for the lack of olfactory toxicity data.

6 In the absence of route-specific data, endpoints for all dermal and inhalation exposure scenarios were identical to those for dichlobenil (parent), since olfactory toxicity has been observed following i.p. administration of BAM in mice [  HYPERLINK "http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itoo l=pubmed_Abstract&term=%22Brittebo+EB%22%5BAuthor%5D"  Brittebo EB ,   HYPERLINK "http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itoo l=pubmed_Abstract&term=%22Eriksson+C%22%5BAuthor%5D"  Eriksson C ,   HYPERLINK "http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itoo l=pubmed_Abstract&term=%22Feil+V%22%5BAuthor%5D"  Feil V ,   HYPERLINK "http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itoo l=pubmed_Abstract&term=%22Bakke+J%22%5BAuthor%5D"  Bakke J ,   HYPERLINK "http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&itoo l=pubmed_Abstract&term=%22Brandt+I%22%5BAuthor%5D"  Brandt I . (1991). Toxicity of 2,6-dichlorothiobenzamide (chlorthiamid) and 2,6-dichlorobenzamide in the olfactory nasal mucosa of mice.   HYPERLINK "javascript:AL_get(this,%20'jour',%20'Fundam%20Appl%20Toxicol.');"  Fundam Appl Toxicol  17(1):92-102].

DEREK Analyses for BAM, Fluopicolide, and Dichlobenil  XE "DEREK Analyses for BAM, Fluopicolide, and Dichlobenil"

Comparative Toxicity using Derek analysis for Dichlobenil, Fluopicolide and BAM, DP Num: 352656, M. Manibusan, 12/MAY/2008.

Brittebo EB, Erkisson C, Feil V, Bakke J, Brandt I. 1991. Toxicidty of 2,6-dichlorothiobenzamide and 2,6-dichlorobenzamide in the olfactory nasal mucosa of mice. Fundam Appl Toxicol. 17(1):92-102.

Carlsson C., Harju M, Bahrami F, Cantillana T, Tysklind M, Brandt I. 2004. Olfactory mucosal toxicity screening and multivariate QSAR modeling for chlorinated benzene derivatives. Arch Toxicol. 78(12):706-15.

Dichlobenil and fluopicolide are pesticides that share a common metabolite and/or environmental degradate, BAM.  Based on rat metabolism studies, BAM is not formed in vivo (<0.09% of the total administered dose in rats) therefore, it has been assumed that neither toxicological profiles for dichlobenil or fluopicolide would be reflective of the toxicity specific for BAM.  Derek analysis focuses on structural similarities of BAM and parent chemicals (dichlobenil and fluopicolide) to determine whether relative toxicity predictions would be different based on structural alerts.

Comparative Toxicity

Overall, Derek is confirmatory of the animal data for fluopicolide and dichlobenil, which forms the bases for the toxicity prediction for BAM.  Based on the available animal data and Derek analyses, BAM does not appear to cause different organ specific toxicities compared to fluopicolide and dichlobenil.  The kidney and liver toxicities are common to all three compounds.  With respect to relative toxicity, conclusions from the evaluation of the animal studies appear to confirm that both fluopicolide and dichlobenil appear to be more or equally toxic compared to BAM.  Based on the Derek evaluation, Derek did not appear to distinguish fluopicolide toxicity compared to BAM based on alerts issued only for the benzamide (BAM) portion of the structure, indicating that the remaining pyridine structure would not contribute significant biological activity.  Derek also confirms the liver toxicity profile and slight to minimal kidney effects evident in the empirical data for all three compounds.

Olfactory Toxicity

Based on dermal and inhalation exposures to dichlobenil and i.p. administration of BAM, olfactory toxicity was determined to be a target organ effect.  The BAM-mediated olfactory toxicity was observed only in one study collected from open literature (Brittebo et al., 1991) at a dose (100 mg/kg) eight times higher than that which caused the same effect using dichlobenil (12 mg/kg i.p.).  No olfactory effects were reported for Fluopicolide.

All three compounds are structurally similar based on sharing the 2,6-chlorinated benzene structure; the 2,6-positioning of chlorines in combination with an electron-withdrawing group in the primary position of the benzene ring is an arrangement that appears to facilitate olfactory mucosa toxicity (Carlsson et. Al. 2005).  Based on this rule based reasoning, the nitrile group on the dichlobenil is a better electron withdrawing group than the amide group on BAM, which is equal or less than the pyridine group on fluopicolide.  This ranking is reflective of the potency of olfactory toxicity exhibited in the animal studies (dichlobenil>BAM>Fluopicolide).

While the olfactory effects are relevant for i.p., inhalation and dermal, these effects may not be directly relevant for the oral route.  No oral studies, to date, have reported olfactory toxicity for these compounds.  For example, a chronic dietary dog study on dichlobenil that assayed for olfactory histopathology did not observe effects on the nasal epithelium from long term exposure.  Therefore, based on the different routes of exposure and the negative long term oral study in the dog, these data indicate that olfactory effects may only occur when by-passing the liver metabolism.

Neurotoxicity

Evidence of potential neurotoxicity in reduced muscle tone were reported in the 90 day rat study at day 4 in males and days 91 and 92 in females at a dose of 49 mg BAM /kg/day and this was used to establish the incidental oral  short and intermediate term endpoint.  Lethargy and ataxia were observed in a dose-range finding pilot study in mice, but effects were resolved after 24 hours.  In addition, a two week dietary study reported clinical signs of neurotoxicity in mice at 375 mg/kg/day, a dose much higher than that established in the 90 day rat study.  Furthermore, fluopicolide was tested in both acute and subchronic neurotoxicity studies and no neurotoxicity findings were reported.

Based on the totality of the data supporting the potential olfactory and potential neurotoxic effects for BAM,  the composite uncertainty factor appears to be more than adequate.

3.0  Dietary Exposure Assessment  XE "3.0  Dietary Exposure Assessment"

Dichlobenil.  Use on Caneberry (Subgroup 13-07A), Bushberry (Subgroup 13-07B).  Summary of Analytical Chemistry and Residue Data.  PP#7E7230, DP Num: 349398, D. Rate, 12/MAR/2008.

	3.1  Food Residue  XE "3.1  Food Residue"

Maximum residues of BAM from dichlobenil field trials on rhubarb, caneberry and bushberry commodities were included in the dietary assessments.  BAM residues found in the previously submitted and reviewed field trial studies are shown in Table 2.1 and 2.2.

Magnitude of BAM Residues in Plants from Use of Dichlobenil

Residues of BAM in crops from dichlobenil field trials are reported in the table below.

Table 3.1  Proposed Uses: BAM Residues in/on Rhubarb, Blueberries, and Blackberries from Field Trials with Dichlobenil.

Commodity	Total Applic. Rate

 (lb ai/A)	PHI (days)	Residue Levels  (ppm)

	n	Min.	Max.	HAFT1	Median	Mean	Std. Dev.

Rhubarb	0.355-0.366	64-83	3	<0.01	<0.01	<0.01	NA	NA	NA

Blueberries3

(42304201)	0.355-0.361	94	3	0.04	0.06	0.014	0.011	0.012	0.002

Blackberries4

(42452803)	0.353-0.364	94	3	<0.01	<0.01	<0.01	NA	NA	NA

Raspberries

No BAM data were submitted on raspberries.  Blackberry data used to set tolerances.

3 DP #179079, C. Olinger, 09/FEB/1993.

4 DP #182600, C. Olinger, 05/MAR/1993.

For the caneberry and bushberry crop groups, residue data on the representative crops (blackberries and blueberries) was translated to the respective individual crops in each crop group without additional data (HED SOP 200.1:  Guidance for Translation of Field Trial Data from Representative Commodities in the Crop Group Regulation to Other Commodities in Each Crop Group/Subgroup, HED Standard Operating Procedure (12/SEP/2000)).

	3.2  Drinking Water Estimates  XE "3.2  Drinking Water Estimates"

Drinking Water Assessment for the BAM (2,6-Dichlorobenzamide) Degradate of Dichlobenil, DP Num:340773, J. Angier, Ph.D., 29/AUG/2007.

Since all of the proposed new uses are either equal to or less than all the application rates used in the previous drinking water assessments for dichlobenil and BAM, a new drinking water assessment was not conducted and remains unchanged from the previous assessment.  The estimated environmental concentrations used in the dietary exposure was 56.2 ppb from SciGrow modeling of BAM residues from dichlobenil use on nutsedge at 10 lb ai/A.  This BAM residue level is higher than estimated residues in surface water.

	3.3  Dietary Exposure (Food and Drinking Water)

2,6-Dichlorobenzamide (BAM) as a Metabolite of Fluopicolide and Dichlobenil.  Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 3 Registration Actions for Fluopicolide on Root Vegetables (Subgroup 1A), Leaves of Root and Tuber Vegetables (Group 2), Bulb Vegetables (Group 3), and Head and Stem Brassica (Subgroup 5A) and Section 3 Registration Actions for Dichlobenil on Rhubarb, Caneberries (Subgroup 13A), Bushberries (Subgroup 13B) and Associated Berry Commodities, DP Number 439722, S. Piper and D. Rate, 10/MAR/2008.

All of the proposed new uses on dichlobenil were incorporated into the most recent dietary assessment listed above.  The results of the analyses are briefly described below:

Conservative acute and chronic (food and drinking water) exposure assessments were conducted.  Maximum residues of BAM from fluopicolide and dichlobenil field trials on food commodities with established/pending tolerances were included in the assessment.  The assessments used 100% crop treated except for apples, blueberries, cherries, cranberries, peaches, pears, and raspberries.  No livestock tolerances are established or proposed for either fluopicolide or dichlobenil.  The acute dietary (food and drinking water) exposure to BAM from fluopicolide and dichlobenil on established and proposed uses is below the Agency’s level of concern for the general U.S. population and all population subgroups.  The acute dietary exposure estimates at the 99.9th percentile of the exposure distribution are 11% of the acute Population Adjusted Dose (aPAD) for the general U.S. population and 28% aPAD for all infants (<1 year old), the most highly exposed group.

The chronic dietary (food and drinking water) exposure to BAM from fluopicolide and dichlobenil on established and proposed uses is below the Agency’s level of concern for the general U.S. population and all population subgroups.  The chronic dietary exposure estimates are 29% chronic Population Adjusted Dose (cPAD) for the general U.S. population and 93% cPAD for all infants (<1 year old), the most highly exposed group which is of concern to HED.  See Table 3.3.

Table 3.3.  Summary of Dietary (Food and Drinking Water) Exposure and Risk for BAM

Population Subgroup	Acute Dietary

(99.9th Percentile)	Chronic Dietary	Cancer

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

(mg/kg/day)	% cPAD	Dietary Exposure

(mg/kg/day)	Risk

General U.S. Population	0.011650	11	0.001317	29	*	*

All Infants (< 1 year old)	0.028470	28	0.004170	93	N/A	N/A

Children 1-2 years old	0.017320	17	0.002284	51

Children 3-5 years old	0.014934	12	0.001985	44

Children 6-12 years old	0.008285	7	0.001297	29

Youth 13-19 years old	0.007207	7	0.000930	21

Adults 20-49 years old	0.008394	8	0.001196	27

Adults 50+ years old	0.006591	7	0.001288	29

Females 13-49 years old	0.008495	28	0.001196	27

4.0  Residential Exposure  XE "4.0  Residential Exposure"

BAM – Occupational Exposure/Risk Assessment of the Metabolite BAM as Results from Proposed Uses of Dichlobenil on Rhubarb, Caneberries (Crop SubGroup 13A) and Bushberries (Crop SubGroup 13B), DP Num: 350517, M. Dow, 27/MAR/2008.

Occupational and Residential Risk Assessment of Metabolite BAM (to Support Request for Registration of Fluopicolide on Brassica, Bulb Vegetables, and Root and Tuber Vegetables),DP Num:347230, K. O’Rourke, 13/DEC/2007.

There are no residential use sites among the proposed new uses of dichlobenil.  While it is necessary to evaluate residential exposure from all sources of BAM, the use pattern for dichlobenil is not expected to result in scenarios with significant residential exposure.  Dichlobenil products are not intended for use by residential handlers.  They may be applied by professional pest control operators (PCOs) to soil/mulch around roses and other woody ornamentals in established residential plantings, but not to residential lawns or turf.  Dermal and incidental oral exposures are expected to be negligible from these sources.  Therefore, BAM exposure estimates are based on fluopicolide use only.

Exposure to BAM from fluopicolide uses on residential turfgrass and recreational sites, such as golf courses, has been evaluated in an earlier assessment (DP Num: 345920, K. O’Rourke, 09/OCT/2007); a summary of the findings are presented in this document.

Residential handler exposure was not evaluated because the metabolite BAM is believed to form slowly in plants and soil after the product containing the parent (fluopicolide) has been applied.

Residential postapplication exposure via the inhalation route is expected to be negligible; however, dermal exposure is likely for adults and children entering treated lawns.  Toddlers may also experience exposure via incidental non-dietary ingestion (i.e., hand-to-mouth, object-to-mouth (turfgrass), and soil ingestion) during postapplication activities on treated turf.  The postapplication risk assessment is based on generic assumptions as specified by the Recommended Revisions to the Residential SOPs and recommended approaches by HED’s Science Advisory Council for Exposure (ExpoSAC).  Because turf transferable residue (TTR) data were not available, turf residues were estimated using standard assumptions (in addition to BAM surface residue data from the metabolism studies).

Exposure and risk estimates for residential exposure scenarios are typically assessed for the day of application (“Day 0”) because it is assumed that adults and toddlers could contact the lawn immediately after application.  However, BAM is a metabolite/degradate which forms slowly; therefore, these scenarios were assessed assuming that BAM is present at levels which reflect high-end measurements observed in the metabolism studies (in which sampling occurred up to 41 and 369 days after application, for plants and soil, respectively) for “Day 0” in order to provide a protective assessment.

As shown in Table 4.0, the short-/intermediate-term dermal MOEs for adults and children are 10,000 and 6,000, respectively, and the combined incidental oral MOE for toddlers is 62,000.  These MOEs are greater than the LOC of 100 for dermal exposure and 1,000 for incidental oral exposure, on the day of application, and therefore, are not of concern.

Table 4.0.  Aggregate Exposure and Risk Estimates from Residential Lawns

Scenario

and

Pathway

TTR/GR/SR0 (µg/cm2 or g) 1

PDR0-norm

(mg/kg/day) 2

Short-/ Int-Term

 MOE 3

Total MOE 4

Short-/

Int-Term

Adult’s Scenarios

(1) Dermal Postapplication	0.0060	0.0025	10,000	N/A

Children’s Scenarios – All Postapplication

(1) Dermal 	0.0060	0.0042	6,000	N/A

(2) Hand-to-Mouth	0.0060	0.00016	87,000	62,000

(3) Mouthing Grass/Object	0.035	0.000058	240,000

(4) Soil Ingestion	0.81	0.0000054	2,600,000

	1 TTR=turf transferable residue on day “0"; GR=grass/object residue on day “0"; SR0=soil residue on day “0".

2 PDR0norm=potential dose rate on day “0”.

3 MOE = NOAEL/PDR;

	where Short-/Intermediate-term Dermal NOAEL = 25 mg/kg/day, and Incidental Oral NOAEL = 14 mg/kg/day.

4 Total Incidental Oral MOE = 1/ [(1/MOEHand-to-Mouth) + (1/MOEGrass) + (1/MOESoil)]

N/A = not applicable.

5.0  Aggregate Exposure  XE "5.0  Aggregate Exposure"

	5.1  Acute Aggregate Risk  XE "5.1  Acute Aggregate Risk"

In examining acute aggregate risk, ARIA/HED has assumed that the only pathway of exposure relevant to the acute time frame is dietary exposure (i.e., any non-dietary exposures are short- and/or intermediate-term in duration).  Therefore, the acute aggregate risk is composed of exposures to BAM residues in food and drinking water and is equivalent to the acute dietary risk shown in Table 3.3.   As noted in that section, the acute risk estimates are well below the Agency’s level of concern for the general U.S. population and all population subgroups.

	5.2  Short- and Intermediate-Term Aggregate Risk  XE "5.2  Short- and Intermediate-Term Aggregate Risk"

No new short- or intermediate-term exposures are expected from the proposed uses for dichlobenil.  Aggregate risk from previously assessed exposures is briefly discussed below.

Short-term exposures (1 to 30 days of continuous exposure) may occur as a result of activities on treated turf.  Incidental oral exposures related to turf activities have been combined with chronic dietary exposure estimates to assess short-term aggregate exposure.  Since aggregate MOEs in Table 5.2 are greater than 1000, they represent risk estimates that are below Agency’s level of concern.

Table 5.2.  Short-Term and Intermediate-Term Aggregate Risk Calculations

(1/MOE Approach – All LOCs Identical)

Population	Short- or Intermediate-Term Scenario

	NOAEL

mg/kg/day	LOC1

	Max Allowable

Exposure2

mg/kg/day	Average

Food & Water

Exposure

mg/kg/day	Residential Exposure3

mg/kg/day	Aggregate MOE

(food and

residential)4

General U.S. Population	14	1000	0.014	0.001317	NA	NA

All Infants (<1 year old)	14	1000	0.014	0.004168	0.0002234	3200

Children 1-2 years old	14	1000	0.014	0.002284	0.0002234	5400

Females 13-49 years old	14	1000	0.014	0.001196	NA	NA

1 UFA  = 10x (extrapolation from animal to human (interspecies); UFH = 10x potential variation in sensitivity among members of the human population (intraspecies); FQPA SFDB = 10x.  10 x 10 x 10 = 1000.

2 Maximum Allowable Exposure (mg/kg/day) = NOAEL/LOC = 14 mg/kg/day ÷ 1000 = 0.014 mg/kg/day.

3 Aggregate MOE = [NOAEL/ (Avg Food & Water Exposure + Residential Exposure)]

	5.3  Long-Term Aggregate Risk  XE "5.3  Long-Term Aggregate Risk"

In examining long-term aggregate risk, ARIA/HED has assumed that the only pathway of exposure relevant to that time frame is dietary exposure (i.e., any non-dietary exposures are short- and/or intermediate-term in duration).  Therefore, the long-term aggregate risk is composed of exposures to BAM residues in food and drinking water and is equivalent to the chronic dietary risk shown in Table 3.3.  As shown in Table 3.3, the chronic risk estimates are below the Agency’s level of concern for the general U.S. population and all population subgroups.

As noted above, EPA has assumed that BAM’s potential for carcinogenicity is similar to that of dichlobenil, which is classified as “Group C, possible human carcinogen”.  ARIA/HED are regulating at a level that would also be protective of potential carcinogenic effects, therefore additional quantification of cancer risk is not needed.

6.0  Cumulative Risk Assessments and Risk Characterization  XE "6.0  Cumulative Risk Assessments and Risk Characterization"

Unlike pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to BAM and any other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that BAM has a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA’s Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA’s website at   HYPERLINK http://www.epa.gov/pesticides/cumulative/. http://www.epa.gov/pesticides/cumulative/.

7.0  Occupational Exposure  XE "7.0  Occupational Exposure"

BAM – Occupational Exposure/Risk Assessment of the Metabolite BAM as Results from Proposed Uses of Dichlobenil on Rhubarb, Caneberries (Crop SubGroup 13A) and Bushberries (Crop SubGroup 13B), DP Num: 350517, M. Dow, 27/MAR/2008.

	7.1 Handler Exposure and Risk  XE "7.1 Handler Exposure and Risk"

Due to the uncertainties regarding the rates and degrees of metabolism from parent dichlobenil to BAM, this assessment conservatively assumes all of parent dichlobenil is converted to BAM.  Therefore, the label rate of application of dichlobenil is assumed to be the equivalent amount of BAM.

Based upon the proposed use patterns, i.e., the rates of formulation per acre, ARIA believes the only method of application will be as a granular broadcast application to the soil using ground equipment.  As such, the most highly exposed occupational pesticide handlers are expected to be loaders performing open-pour loading of granules and applicators using open-cab tractors pulling broadcast granular spreaders.

For such ground applications, private (i.e., grower) applicators may perform all functions, that is, mix, load and apply the material.  The HED ExpoSAC SOP Number 12 (29 March 2000) directs that although the same individual may perform all those tasks, they shall be assessed separately.  The available exposure data for combined mixer/loader/applicator scenarios are limited in comparison to the monitoring of these two activities separately.  These exposure scenarios are outlined in the Pesticide Handler Exposure Database (PHED) Surrogate Exposure Guide (August 1998).   HED has adopted a methodology to present the exposure and risk estimates separately for the job functions in some scenarios and to present them as combined in other cases.  Most exposure scenarios for hand-held equipment (such as hand wands, backpack sprayers, and push-type granular spreaders) are assessed as a combined job function.  With these types of hand held operations, all handling activities are assumed to be conducted by the same individual.  The available monitoring data support this and HED presents them in this way.  Conversely, for equipment types such as fixed-wing aircraft, groundboom tractors, or air-blast sprayers, the applicator exposures are assessed and presented separately from those of the mixers and loaders.  By separating the job functions, HED determines the most appropriate levels of personal protective equipment (PPE) for each aspect of the job without requiring an applicator to wear unnecessary PPE that might be required for a mixer/loader (e.g., chemical resistant gloves may only be necessary during the pouring of a liquid formulation).

No chemical specific data were available with which to assess potential exposure to pesticide handlers.  The estimates of exposure to pesticide handlers are based upon surrogate study data available in the PHED (v. 1.1, 1998).   For pesticide handlers, it is HED standard practice to present estimates of dermal exposure for “baseline” that is, for workers wearing a single layer of work clothing consisting of a long sleeved shirt, long pants, shoes plus socks and no protective gloves as well as for baseline and the use of protective gloves or other PPE as might be necessary.

The toxicological factors used to estimate risk from exposures to BAM are taken from:  Occupational and Residential Risk Assessment of Metabolite BAM (to Support Request for Registration of Fluopicolidee on Brassica, Bulb Vegetables, and Root and Tuber Vegetables, DP Num: 347230, K. O’Rourke, 13/DEC/2007.

The Agency identified dermal toxicological endpoints for short-term duration (1-30 days), intermediate-term duration (1-6 months) and long-term duration (> 6 months) exposures.  The No Observable Adverse Effect Level (NOAEL) is 25.0 mg ai/kg bw/day.  The toxic effect seen was olfactory epithelial damage and was identified from a 5-day dermal toxicity study in the mouse.   Since the dermal endpoints were identified from a dermal study, there is no correction for dermal absorption in the estimates of exposure.  A body weight of 70 kg is used to calculate exposure.

The Agency also identified inhalation toxicological endpoints.  The NOAEL is 3.1 mg ai/kg bw/day which caused nasal degeneration.  The effects were identified from a 28-day inhalation study in the rat.  HED and RD assume 100 % absorption via the inhalation route of exposure.   A 70 kg body weight is used to calculate exposure.

BAM is formally unclassified relative to carcinogenic potential.   However, the parent compound, dichlobenil, is classified as a “Group C”, possible human carcinogen with the RfD approach recommended for quantification of human risk.   Since long-term exposure is not expected, a cancer risk assessment is not necessary.

See Table 7.1 for a summary of exposures and risks to occupational pesticide handlers.

Table 7.1  Summary of Exposure & Risk for Occupational Handlers Exposed to BAM as a Result of Applying Dichlobenil

Unit Exposure1

mg ai/lb handled	Applic. Rate2

lb ai/unit	Units Treated3	Avg. Daily Exposure4

mg ai/kg bw/day	MOE5	Combined

MOE6

Loader Using Open-pour Loading of Granules

Dermal:

SLNoGlove      0.0084 LC

SLWithGlove   0.0069 MC

Inhal.                0.0017 HC	6.0 lb ai/A	40 A/day	Dermal:

SLNoGlove    0.0288

SLWithGlove 0.024

Inhal.              0.00583

870

1,040

531

330

352

Applicator Using Open-cab Broadcast Application of Granules

Dermal:

SLNoGlove       0.0099 LC

SLWithGlove    0.0072 LC

Inhal.                 0.0012 LC	6.0 lb ai/A	40 A/day	Dermal:

SLNoGlove     0.034

SLWithGlove  0.025

Inhal.               0.00411

735

1,000

754

371

430

1.  Unit Exposures are taken from “PHED SURROGATE EXPOSURE GUIDE”, Estimates of Worker Exposure from The Pesticide Handler Exposure Database Version 1.1, August 1998.   Inhal. = Inhalation.  Units = mg a.i./pound of active ingredient handled.  Data Confidence: LC = Low Confidence, MC = Medium Confidence, HC = High Confidence.

2.  Applic. Rate. = Taken from the  IR4 Submission, Section B

3.  Units Treated are taken from “Standard Values for Daily Acres Treated in Agriculture”; SOP  No. 9.1.   Science Advisory Council for Exposure;  Revised 5 July 2000;

4.  Average Daily Dose (ADD) = Unit Exposure * Applic. Rate * Units Treated ( Body Weight (70 kg)

5.  MOE = Margin of Exposure = No Observable  Adverse Effect Level (NOAEL)  ( ADD.    NOAEL = No Observable Adverse Effect Level (25 mg a.i./kg bw/day for  dermal and 3.1 mg ai/kg bw/day for inhalation)

6.  Combined MOE = 1/(1/MOEDermal ) + (1/MOEInhalation)

A MOE of 100 is adequate to protect occupational pesticide handlers from exposures to BAM.  Since the combined MOEs are all > 100, the proposed uses do not exceed the Agency’s level of concern.

	7.2  Postapplication Exposure and Risk  XE "7.2  Postapplication Exposure and Risk"

For the proposed uses, application of dichlobenil to control perennial weeds is recommended as a late fall soil treatment, from 15 November to 15 February.  For control of annual weeds, applications are recommended in early spring, before 1 May.  Applications are either followed by shallow mechanical incorporation or via "watering-in".

Due to the recommended timing of application and to the method of application, ARIA expects any occupational, post-application exposure to be negligible.  Since it is a granular formulation applied essentially during "dormant" times, foliar dislodgeable residue exposure is not expected.  Therefore, a post-application exposure assessment was not conducted herein.

8.0  Data Needs and Label Recommendations  XE "8.0  Data Needs and Label Recommendations"

	8.1	Toxicology  XE "8.1	Toxicology"    XE "8.1	Toxicology"

None.

	8.2	Residue Chemistry  XE "8.2	Residue Chemistry"

None

	8.3	Occupational and Residential Exposure  XE "8.3	Occupational and Residential Exposure"

None.

9.0  References  XE "9.0  References"

Amended: Dichlobenil.  Use on Caneberry (Subgroup 13-07A), Bushberry (Subgroup 13-07B).  Summary of Analytical Chemistry and Residue Data.  PP#7E7230. DP Num: 349398, D. Rate, 11/JUN/2008.

2,6-Dichlorobenzamide (BAM) as a Metabolite of Fluopicolide and Dichlobenil.  Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 3 Registration Actions for Fluopicolide on Root Vegetables (Subgroup 1A), Leaves of Root and Tuber Vegetables (Group 2), Bulb Vegetables (Group 3), and Head and Stem Brassica (Subgroup 5A) and Section 3 Registration Actions for Dichlobenil on Rhubarb, Caneberries (Subgroup 13A), Bushberries (Subgroup 13B) and Associated Berry Commodities, DP Num:  439722, S. Piper and D. Rate, 19/MAR/2008.

Drinking Water Assessment for the BAM (2,6-Dichlorobenzamide) Degradate of Dichlobenil, DP Num: 340773, J. Angier, Ph.D., 29/AUG/2007.

Occupational and Residential Risk Assessment of Metabolite BAM (to Support Request for Registration of Fluopicolide on Brassica, Bulb Vegetables, and Root and Tuber Vegetables), , DP Num: 347230, K. O’Rourke, 13/DEC/2007.

BAM – Occupational Exposure/Risk Assessment of the Metabolite BAM as Results from Proposed Uses of Dichlobenil on Rhubarb, Caneberries (Crop SubGroup 13A) and Bushberries (Crop SubGroup 13B), DP Num: 350517, M. Dow, 27/MAR/2008.

Comparative Toxicity using Derek analysis for Dichlobenil, Fluopicolide and BAM, DP Num: 352656, M. Manibusan, 12/MAY/2008.

Appendix A:  Toxicity Profile Table and Executive Summaries/Published Abstracts   TC \l1 " Appendix A:  Toxicity Profile Table and Executive Summaries/Published Abstracts

Table A.1.  Acute toxicity profile for soil metabolite 2,6-dichlorobenzamide (BAM)a

Guideline No./Study Type

MRID No.

Results	Toxicity Category

870.1100/Acute oral toxicity (mouse)	42940201

1538/1144 mg/kg (M/F)	III

a According to Reregistration Eligibility Decision (1998)

Table A.2.  SUBCHRONIC, CHRONIC, AND GENO- TOXICITY PROFILE FOR METABOLITE, 2,6-DICHLOROBENZAMIDE (BAM)

Guideline No./

Study Type

MRID No. (Year)/Doses/ Classification

Results

870.3100

90-day oral (rat; dietary)

00067654 (1967)

0, 50, 180, 600, or 2300 ppm (equal to 0, 4, 14, 49, or 172 mg/kg/day)

Acceptable/Guideline

NOAEL = 14 mg/kg/day

LOAEL = 49 mg/kg/day based on decreased body weight gain (M) and reduced skeletal muscle tone (M&F).

870.3150

90-day oral (dog; dietary)

00067655 (1967)

0, 100, 300, or 2000 ppm (equal to 0, 7.5, 22.5, or 150 mg/kg/day)

Unacceptable/Guideline due to parasitic infections (ascariasis) in most animals

NOAEL = 22.5 mg/kg/day

LOAEL = 150 mg/kg/day based on clinical signs (thin appearance, dull coat, hair loss) and increased liver weight and serum alkaline phosphatase concentrations (F) and clinical signs (thin appearance, dull coat, hair loss) (M).

870.4700

Chronic toxicity oral (dogs; dietary)

42940203 (1971)

0, 60, 100, 180, or 500 ppm (equal to 0, 1.5, 2.5, 4.5, or 12.5 mg/kg/day)

Acceptable/Guideline

NOAEL = 4.5 mg/kg/day

LOAEL = 12.5 mg/kg/day based on decreased body weight and body weight gain.

870.4300

Combined Chronic Toxicity/ Carcinogenicity oral (rat; dietary)

42940202 (1971), 44043601 (1996), 44052901 (1996)

0, 60, 100, 180, or 500 ppm [equal to 0, 2.2/2.8, 3.6/4.7, 6.5/8.5, or 19/25 mg/kg/day (M/F)]

Acceptable/Guideline

NOAEL = 6.5 (M) and 4.7 mg/kg/day (F)

LOAEL = 19 mg/kg/day (M) and 8.5 mg/kg/day (F) based on decreased body weight and body weight gain (≥ week 26) and an increased incidence of hepatocellular alteration (eosinophilic foci).

Borderline statistically significant (P=0.049) increased incidence of hepatocellular adenomas at 25 mg/kg/day (F only); dosing considered adequate (M&F).

870.3700

Developmental toxicity oral (rabbit; gavage)

43003601 (1986), 43265201 (1994)

0, 10, 30, or 90 mg/kg/day

Acceptable/Guideline

Maternal NOAEL= 30 mg/kg/day

Maternal LOAEL= 90 mg/kg/day based on increased incidences of clinical signs (late abortion, thin appearance) and decreased (severe) body weight gain and food consumption during dosing.

Developmental NOAEL = 30 mg/kg/day

Developmental LOAEL = 90 mg/kg/day based on increased

incidences of late abortion and skeletal (bipartite interparietal

bone) and visceral (postcaval lung lobe agenesis) anomalies.

870.3800

3-generation reproduction oral (rat; dietary)

	42940204 (1971)

0, 60, 100, or 180 ppm (equivalent 0, 4.5, 7.5, or 13.5 mg/kg/day)

Unacceptable/Guideline due to lack of individual animal data	Parental NOAEL = 13.5 mg/kg/day

Parental LOAEL was not observed.

Reproductive NOAEL = 13.5 mg/kg/day

Reproductive LOAEL was not observed.

Offspring NOAEL = 13.5 mg/kg/day

Offspring LOAEL was not observed.

Non-guideline (literature)

Adult mouse olfactory study (single injection; i.p.)	Brittebo et al. (1991); no MRID

0, 25, 50, or 100 mg/kg/day (i.p.)

f (PAS) staining of contents of Bowman’s glands (measure of mucus production) observed at ≥25 mg/kg/day (reversible); degeneration of olfactory epithelium and necrosis of Bowman’s glands observed at 100 mg/kg/day (sustained).

870.5100

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3everse mutation (Ames test)

43003603 (1992)

At concentrations up to 5000 g/plate (-/+ activation) in S. typhimurium

Acceptable/Guideline

Negative with or without activation.

870.5395

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43003602 (1993), 43747101 (1995)

0, 250 mg/kg

Acceptable/Guideline

Negative.

Lethargy observed in dose-range finding (pilot) study at 100 mg/kg/day (=LOAEL; NOAEL not observed); clinical signs worsened with increasing dose.

870.5550

 h

	g/ml

Acceptable/Guideline

Negative.

Page   PAGE  18  of   NUMPAGES  18

Page   PAGE  1  of   NUMPAGES  18


[Federal Register: March 3, 2009 (Volume 74, Number 40)]
[Notices]
[Page 9255]
[DOCID:fr03mr09-70]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1819-DR; Docket ID FEMA-2008-0018]

Arkansas; Amendment No. 3 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Arkansas (FEMA-1819-DR), dated February 6, 2009, and
related determinations.

DATES: Effective Date: February 24, 2009.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Arkansas is hereby amended to include the following
area among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of February 6, 2009.

    Pope County for Public Assistance.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Nancy Ward,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. E9-4503 Filed 3-2-09; 8:45 am]

BILLING CODE 9111-23-P


[Federal Register Volume 87, Number 126 (Friday, July 1, 2022)]
[Rules and Regulations]
[Pages 39345-39348]
[FR Doc No: 2022-14067]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0682; FRL-9932-01-OCSPP]

Sodium Dioctyl Sulfosuccinate (CAS Reg. No. 577-11-7); Tolerance
Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of sodium dioctyl sulfosuccinate (CAS Reg.
No. 577-11-7) when used as an inert ingredient in antimicrobial
pesticide formulations applied to food-contact surfaces in public
eating places, dairy-processing equipment, and food-processing
equipment and utensils under 40 CFR 180.940(a). Spring Regulatory
Sciences, on behalf of Evonik Corporation, submitted a petition to EPA
under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of sodium dioctyl sulfosuccinate (CAS Reg. No. 577-11-7) when
used in accordance with this exemption.

DATES: This regulation is effective July 1, 2022. Objections and
requests for hearings must be received on or before August 30, 2022 and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0682, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and the OPP Docket is<PHONE_NUMBER>. Please review the
visitor instructions and additional information about the docket
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following

list of North American Industrial Classification System (NAICS) codes
is not intended to be exhaustive, but rather provides a guide to help
readers determine whether this document applies to them. Potentially
affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Office of the Federal Register's e-CFR site at
https://www.ecfr.gov/current/title40.

C. Can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2021-0682 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
August 30, 2022. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2021-0682, by one of
the following methods.
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of October 21, 2021 (86 FR 58239) (FRL-
8792-04-OCSPP), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-
11566) by Spring Regulatory Sciences (6620 Cypresswood Dr, Suite 250,
Spring, TX 77379), on behalf of Evonik Corporation, (P.O. Box 34628,
Richmond, VA 23234). The petition requested that 40 CFR 180.940(a) be
amended by establishing an exemption from the requirement of a
tolerance for residues of sodium dioctyl sulfosuccinate (CAS Reg. No.
577-11-7) for use as an inert ingredient in antimicrobial pesticide
formulations. That document referenced a summary of the petition
prepared by the petitioner, which is available in the docket, and
solicited comments on the petitioner's request at http://regulations.gov. There were no comments received in response to the
notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue.''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown that the risks from aggregate
exposure to pesticide chemical residues under reasonably foreseeable
circumstances will pose no harm to human health. In order to determine
the risks from aggregate exposure to pesticide inert ingredients, the
Agency considers the toxicity of the inert in conjunction with possible
exposure to residues of the inert ingredient through food, drinking
water, and through other exposures that occur as a result of pesticide
use in residential settings. If EPA is able to determine that a
tolerance is not necessary to ensure that there is a reasonable
certainty that no harm will result from aggregate exposure to the inert
ingredient, an exemption from the requirement of a tolerance may be
established.
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action and considered its validity, completeness and reliability and
the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. EPA has sufficient data to assess the hazards of
and to make a determination on aggregate exposure to sodium dioctyl
sulfosuccinate including exposure resulting from the exemption
established by this action. EPA's assessment of exposures and risks
associated with sodium dioctyl sulfosuccinate follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Sodium dioctyl sulfosuccinate is also known as dioctyl sodium
sulfosuccinate or DSS. Specific information on the studies received and
the nature of the adverse effects caused by sodium dioctyl
sulfosuccinate, as well as the no-observed-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity
studies, are discussed in the November 5, 2012 document titled
``Dioctyl Sodium Sulfosuccinate: Preliminary Human Health Risk
Assessment in Support of Registration Review,'' which is available at
https://www.regulations.gov in docket ID number EPA-HQ-OPP-2010-1006,
and in the June 10th, 2022 document titled ``IN-11566; Petition to an
amend Tolerance Exemption for Sodium dioctyl sulfosuccinate (CAS No.
577-11-7), adding it to the approved list of food use inert ingredients
under 40 CFR 180.940(a) in Pesticide Formulations.'' which is available
at https://www.regulations.gov in the docket for this action.
    Sodium dioctyl sulfosuccinate has low acute oral, dermal and
inhalation toxicity. It is neither a skin sensitizer nor a skin or eye
irritant. Toxicity to offspring occurred in the reproduction and
developmental studies only at the limit dose and in the presence of
parental toxicity. The subchronic toxicity, chronic toxicity, and
mutagenicity studies did not demonstrate any significant toxicity of
sodium dioctyl sulfosuccinate.
    In a 90-day oral toxicity study in Sprague-Dawley rats with sodium
dioctyl sulfosuccinate, no adverse effects were observed up to the
highest dose tested and the NOAEL is 1000 mg/kg/day.

B. Toxicological Points of Departure/Levels of Concern

    The toxicological points of departure/levels of concern of sodium
dioctyl sulfosuccinate remain unchanged from the Toxicological Profile
in Preliminary Human Health Risk Assessment in Support of Registration
Review. D405928, November 5, 2012. No toxicological endpoints of
concern were identified for sodium dioctyl sulfosuccinate because there
was no offspring susceptibility and the only effects observed occurred
at the limit dose.

C. Exposure Assessment

    Dietary and residential (non-occupational and non-dietary)
exposures are expected from the proposed and existing uses of sodium
dioctyl sulfosuccinate. However, no quantitative dietary or residential
exposure assessments were conducted because no toxicological endpoints
of concern were identified.

D. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    EPA has not determined that sodium dioctyl sulfosuccinate share a
common mechanism of toxicity with any other substances, and sodium
dioctyl sulfosuccinate does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this action,
therefore, EPA has assumed that sodium dioctyl sulfosuccinate does not
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's website at https://www.epa.gov/pesticides/cumulative.

E. Safety Factor for Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database unless EPA concludes that
a different margin of safety will be safe for infants and children.
Based on an assessment of sodium dioctyl sulfosuccinate, EPA has
concluded that there are no toxicological endpoints of concern for the
U.S. population, including infants and children, and a qualitative
assessment is being conducted for sodium dioctyl sulfosuccinate. The
qualitative assessment does not use safety factors for assessing risk,
and no additional safety factor is needed for assessing risk to infants
and children.

F. Determination of Safety

    Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the general population, or to infants and children, from
aggregate exposure to sodium dioctyl sulfosuccinate residues. More
detailed information about the Agency's analysis can be found at
https://www.regulations.gov in the November 5, 2012 document titled
``Dioctyl Sodium Sulfosuccinate: Preliminary Human Health Risk
Assessment in Support of Registration Review'' in docket ID number EPA-
HQ-OPP-2010-1006, and in the June 10th, 2022 document titled ``IN-
11566; Petition to an amend Tolerance Exemption for Sodium dioctyl
sulfosuccinate (CAS No. 577-11-7), adding it to the approved list of
food use inert ingredients under 40 CFR 180.940(a) in Pesticide
Formulations.'' in the docket for this action.

V. Other Considerations

Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
sodium dioctyl sulfosuccinate in or on any food commodities.

VI. Conclusion

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.940(a) for sodium dioctyl sulfosuccinate
when used as an inert ingredient in antimicrobial pesticide
formulations applied to food-contact surfaces in public eating places,
dairy-processing equipment, and food-processing equipment and utensils.

VII. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section
408(d) in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997).

This action does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et
seq.), nor does it require any special considerations under Executive
Order 12898, entitled ``Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations'' (59 FR
7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemption in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule 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. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: June 22, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.940, amend Table 1 to Paragraph (a) by adding, in
alphabetical order, an entry for ``Sodium dioctyl sulfosuccinate'' to
read as follows:

Sec.  180.940  Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).

* * * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
       Pesticide chemical         CAS Reg. No.            Limits
------------------------------------------------------------------------

                              * * * * * * *
Sodium dioctyl sulfosuccinate..        577-11-7  None.

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

* * * * *
[FR Doc. 2022-14067 Filed 6-30-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: October 25, 2010 (Volume 75, Number 205)]
[Notices]
[Page 65501]
[DOCID:fr25oc10-81]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1943-DR; Docket ID FEMA-2010-0002]

New York; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of New York (FEMA-1943-DR), dated October 14,
2010, and related determinations.

DATES: Effective Date: October 14, 2010.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated October 14, 2010, the President issued a major disaster
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''), as follows:

    I have determined that the damage in certain areas of the State
of New York resulting from severe storms, tornadoes, and straight-
line winds on September 16, 2010, is of sufficient severity and
magnitude to warrant a major disaster declaration under the Robert
T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C.
5121 et seq. (the ``Stafford Act''). Therefore, I declare that such
a major disaster exists in the State of New York.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance and Hazard Mitigation will be limited to 75
percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Philip E. Parr, of FEMA is appointed
to act as the Federal Coordinating Officer for this major disaster.
    The following areas of the State of New York have been designated
as adversely affected by this major disaster:

    Kings, Queens, and Richmond Counties for Public Assistance.
    All counties within the State of New York are eligible to apply
for assistance under the Hazard Mitigation Grant Program.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-26848 Filed 10-22-10; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 75, Number 67 (Thursday, April 8, 2010)]
[Notices]
[Pages 17981-17983]
[FR Doc No: 2010-7976]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61829; File No. SR-BX-2010-023]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
Market Maker Quoting Obligations

April 1, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on March 26, 2010, NASDAQ OMX BX, Inc. (the ``Exchange'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II, and III below, which Items
have been prepared by the Exchange. The Exchange filed the proposed
rule change pursuant to Section 19(b)(3)(A) of the Act,\3\ and Rule
19b-4(f)(6) thereunder,\4\ which renders the proposal effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Chapter VI, Section 6 (Market Maker
Quotations) of the Rules of the Boston Options Exchange Group, LLC
(``BOX''). The text of the proposed rule change is available from the
principal office of the Exchange, at the Commission's Public Reference
Room, on the Exchange's Internet Web site at http://nasdaqomxbx.cchwallstreet.com/NASDAQOMXBX/Filings/, and on the
Commission's Web site at http://www.sec.gov/.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of

the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of this proposed rule change is to update certain
quoting obligations of Market Makers.
    Presently, a Market Maker must participate in the pre-opening phase
and thereafter make markets such that on a daily basis a Market Maker
posts quotes at least eighty percent (80%) of the time an appointed
options class is open for trading, for at least ninety percent (90%) of
the classes to which the Market Maker is appointed and for at least
sixty percent (60%) of the time in each of its appointed classes during
the time that the class(es) are open for trading.\5\
---------------------------------------------------------------------------

    \5\ See Chapter VI, Section 6(d) of the BOX Rules.
---------------------------------------------------------------------------

    Due to the fact that all Market Makers on BOX will still have some
minimum quoting obligations and that Market Makers are not the only
source of liquidity on BOX (e.g., OFP and Public Customer Orders also
provide liquidity), the Exchange no longer believes that it is
necessary for a Market Maker to be held to this level of quoting to
ensure adequate liquidity on BOX in a particular class. Therefore, the
Exchange is proposing to update Chapter VI, Section 6(d) of the BOX
Rules such that during continuous trading, on a daily basis, a Market
Maker must post quotes at least sixty percent (60%) of the time that
its appointed class(es) are open for trading. These obligations will
apply to all of the Market Maker's appointed classes collectively,
rather than on a class-by-class basis.
    The Exchange notes that no changes are being proposed regarding
Market Makers' other obligations, including obligations to participate
in the pre-opening phase. Furthermore, a Market Maker may continue to
be called upon by an Options Official\6\ to submit a single valid two-
sided quote in one or more of the series of an options class to which
the Market Maker is appointed whenever, in the judgment of such
official, it is necessary to do so in the interest of fair and orderly
markets.\7\ Because the Market Makers' remaining obligations, including
those mentioned above, will continue, the Exchange believes this
justifies any benefits they receive due to their appointment as Market
Maker on BOX.
---------------------------------------------------------------------------

    \6\ The term ``Options Official'' means an officer of BOX
Regulation vested by the BOX Regulation Board with certain authority
to supervise option trading on BOX. See BOX Rules Chapter I, Section
1(a)(44).
    \7\ See BOX Rules Chapter VI, Section 6(b)(iv).
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    The Exchange also seeks to set forth certain exemptions within
Chapter VI, Section 6(d). Specifically, when determining if a Market
Maker has met its 60% quoting obligation, the Exchange would not
consider the duration of any periods where a technical failure of the
BOX Trading Host prevents the Market Maker from providing continuous
quotations. Also, an Options Official of the Exchange would retain the
discretion to consider other exceptions to this continuous electronic
quoting obligation based on demonstrated legal or regulatory
requirements or other mitigating circumstances.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act,\8\ in general, and Section
6(b)(5) of the Act,\9\ in particular, in that it is designed to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism for a free and open market and a national market
system and, in general, to protect investors and the public interest.
In particular, the proposed changes will more closely align the quoting
obligations of Market Makers with the levels the Exchange deems
necessary to help ensure that there is adequate liquidity on BOX in
each of the classes to which a particular Market Maker is appointed.
Furthermore, the proposed changes will result in such quoting
obligations being closer to the quoting obligations in effect on
another options exchange.\10\
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
    \10\ See Rule 6.37B (Market Maker Quotations-OX) of the Rules of
NYSE Arca, Inc (``NYSE Arca'').
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    The Exchange has neither solicited nor received comments on the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    This proposed rule change is filed pursuant to paragraph (A) of
section 19(b)(3) of the Exchange Act \11\ and Rule 19b-4(f)(6)
thereunder.\12\
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6). In addition, as required under Rule
19b-4(f)(6)(iii), the Exchange has submitted to the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and the text of the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
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    This proposed rule change does not significantly affect the
protection of investors or the public interest, does not impose any
significant burden on competition, and, by its terms, does not become
operative for 30 days after the date of the filing, or such shorter
time as the Commission may designate if consistent with the protection
of investors and the public interest.
    The Exchange notes that the changes proposed herein will align the
quoting percentage obligations of Market Makers, as well as exceptions
thereto, with those of market makers on NYSE Arca.\13\ In addition, the
Market Makers' other remaining obligations are substantially similar to
those for market makers on NYSE Arca. The Exchange believes that this
proposed rule change, which is essential for competitive purposes and
to promote a free and open market for the benefit of investors, does
not raise any new, unique or substantive issues from those attendant
with the approved NYSE Arca rule.
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    \13\ See supra note 10.
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-BX-2010-023 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-BX-2010-023. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room on official business
days between the hours of 10 a.m. and 3 p.m. Copies of such filing also
will be available for inspection and copying at the principal office of
the Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
publicly available. All submissions should refer to File Number SR-BX-
2010-023 and should be submitted on or before April 29, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-7976 Filed 4-7-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 7 (Friday, January 10, 2014)]
[Rules and Regulations]
[Pages 1734-1735]
[FR Doc No: 2014-00219]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

17 CFR Part 200

[Release No. 34-71238]

Responsibilities of the General Counsel

AGENCY: Securities and Exchange Commission.

ACTION: Final rule.

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SUMMARY: The Securities and Exchange Commission (``Commission'') is
amending its rules to reflect that the Commission's General Counsel is
responsible for providing advice to Commission attorneys on
professional responsibility issues relating to their official duties
and investigating allegations of professional misconduct by Commission
staff and, where appropriate, making referrals to state professional
boards or societies.

DATES: Effective Date: January 10, 2014.

FOR FURTHER INFORMATION CONTACT: Richard M. Humes, Associate General
Counsel, at<PHONE_NUMBER>, Securities and Exchange Commission, 100 F
Street NE., Washington, DC 20549; Shira Pavis Minton, Ethics Counsel,
at<PHONE_NUMBER>, Securities and Exchange Commission, 100 F Street
NE., Washington, DC 20549.

SUPPLEMENTARY INFORMATION:

I. Discussion

    These amendments conform the Commission's regulations, in part 200
of Title 17 of the Code of Federal Regulations, to the current
responsibilities of the General Counsel. They do so by adding language
that describes the General Counsel's responsibility for providing
advice to Commission attorneys on professional responsibility issues
relating to their official duties, investigating allegations of
professional misconduct by Commission staff and, where appropriate,
making referrals to state professional boards or societies. In
addition, the amendments clarify that the Ethics Counsel is not
responsible for investigating and potentially referring allegations of
professional misconduct by Commission staff. Finally, the amendments
include several minor corrections to provisions that relate to the
responsibilities of the Ethics Counsel.

II. Related Matters

A. Administrative Procedure Act and Other Administrative Laws

    The Commission has determined that these amendments to its rules
relate

solely to the agency's organization, procedure, or practice.
Accordingly, the provisions of the Administrative Procedure Act
regarding notice of proposed rulemaking and opportunity for public
participation are not applicable.\1\ The Regulatory Flexibility Act,
therefore, does not apply.\2\ Because these rules relate solely to the
agency's organization, procedure, or practice and do not substantially
affect the rights or obligations of non-agency parties, they are not
subject to the Small Business Regulatory Enforcement Fairness Act.\3\
Finally, these amendments do not contain any collection of information
requirements as defined by the Paperwork Reduction Act of 1995, as
amended.\4\
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    \1\ 5 U.S.C. 553(b).
    \2\ 5 U.S.C. 601-612.
    \3\ 5 U.S.C. 804.
    \4\ 44 U.S.C. 3501-3520.
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B. Consideration of Burden on Competition

    Section 23(a)(2) of the Exchange Act requires the Commission, in
making rules pursuant to any provision of the Exchange Act, to consider
among other matters the impact any such rule would have on competition.
The Commission does not believe that the amendments that the Commission
is adopting today will have any impact on competition.

Statutory Authority

    The amendments to the Commission's rules are adopted pursuant to 15
U.S.C. 77o, 77s, 77sss, 78d, 78d-1, 78d-2, 78w, 78ll(d), 78mm, 80a-37,
80b-11, and 7202.

List of Subjects in 17 CFR Part 200

    Administrative practice and procedure, Authority delegations
(Government agencies), Organization and functions (Government
agencies).

Text of Amendments

    In accordance with the preamble, the Commission hereby amends Title
17, Chapter II of the Code of Federal Regulations as follows:

PART 200--ORGANIZATION; CONDUCT AND ETHICS; AND INFORMATION AND
REQUESTS

Subpart A--Organization and Program Management

0
1. The authority citation for part 200, Subpart A, continues to read,
in part, as follows:

    Authority: 15 U.S.C. 77o, 77s, 77sss, 78d, 78d-1, 78d-2, 78w,
78ll(d), 78mm, 80a-37, 80b-11, 7202, and 7211 et seq., unless
otherwise noted.
* * * * *

0
2. In Sec.  200.21 paragraph (a), after the fourth sentence, that
begins with ``In addition, he or she is responsible'', add two new
sentences to read as follows:

Sec.  200.21  The General counsel.

    (a) * * * The General Counsel is responsible for providing advice
to Commission attorneys on professional responsibility issues relating
to their official duties. The General Counsel is further responsible
for investigating allegations of professional misconduct by Commission
staff and, where appropriate, making referrals to state professional
boards or societies. * * *
* * * * *

Sec.  200.21a  [Amended]

0
3. In Sec.  200.21a:
0
a. In paragraph (a), remove the phrase ``Office of Administrative and
Personnel Management,'' and add in its place, ``Office of Human
Resources, the Office of Government Ethics,'';
0
b. In paragraph (b)(1), at the end of the paragraph, add the phrase
``that relate to the Commission's Ethics Program'' before the period;
0
c. In paragraph (b)(2), at the end of the paragraph, add the phrase ``,
which the Ethics Counsel shall refer to the General Counsel'' before
the period;
0
d. Remove paragraph (b)(7);
0
e. Redesignate paragraph (b)(8) as (b)(7).

Subpart M--Regulation Concerning Conduct of Members and Employees
and Former Members and Employees of the Commission

0
4. The authority citation for Part 200, Subpart M, continues to read as
follows:

    Authority: 15 U.S.C. 77s, 77sss, 78w, 80a-37, 80b-11; E.O.
11222, 3 CFR, 1964-1965 Comp., p. 36; 5 CFR 735.104 and 5 CFR 2634;
and 5 CFR 2635, unless otherwise noted.

Sec.  200.735-15  [Amended]

0
5. In Sec.  200.735-15:
0
a. Remove paragraph (b).
0
b. Redesignate paragraphs (c), (d) (e) and (f) as paragraphs (b), (c),
(d) and (e), respectively.
0
c. In the first sentence of newly redesignated paragraph (b), remove
the words ``any Deputy Counselor or''.
0
d. In newly redesignated paragraph (c), remove the words ``and Deputy
Counselors''. Also in newly redesignated paragraph (c), remove the
words ``they receive'' and add in their place ``he or she receives''
wherever they appear.

    Dated: January 6, 2014.

    By the Commission.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2014-00219 Filed 1-9-14; 8:45 am]
BILLING CODE 8011-01-P