UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, DC  20460

OFFICE OF PREVENTION,

PESTICIDES AND TOXIC SUBSTANCES

MEMORANDUM

Date:		20 May 2008

Subject:	Pendimethalin.  Human Health Risk Assessment for the Proposed Food/Feed Use of the Herbicide (Associated with Section 18 Registration) on Bermuda Grass Pastures and Hay Fields in Texas.

	PC Code:  108501					DP Barcode:  349723

	MRID Number:  (None)				Decision Number:  390012

	Petition Number:  08TX07				Registration Number:  241-418

	Assessment Type:  Single Chemical/Aggregate	Regulatory Action:  Section 18

	TXR Number:  (None)					Reregistration Case Number:  (None)

	Regulatory Citation:  40CFR §180.361		CAS Number:  40487-42-1

	Chemical Class:  Dinitroaniline Herbicide		Trade Name:  Prowl® H20

From:		William T. Drew, Chemist and Risk Assessor

		Shih-Chi Wang, Biologist and ORE Assessor

		Registration Action Branch 2 (RAB2)

		Health Effects Division (HED), 7509P

Through:	Dennis McNeilly, Chemist

		Michael A. Doherty, PhD, Senior Scientist

		RAB2/HED, 7509P

To:		Stacey Groce and Daniel Rosenblatt, RM Team 5

		Risk Integration Minor Use & Emergency Response Branch (RIMUERB)

		Registration Division (RD), 7505P

1.0	Conclusions

	As summarized below, this Crisis Exemption/Section 18 use on Bermuda grass in Texas will not affect the dietary burden or tolerances for existing registered crop uses.  Since the aggregate exposures resulting from currently registered pendimethalin uses are not of concern to HED, the crisis exemption and proposed Section 18 use on Bermuda grass are also not of concern to HED.  Occupational risks, in terms of margins of exposure (MOEs), from the proposed use on Bermuda grass are all estimated to be greater than 30 with baseline clothing, and are therefore not of concern to HED.

	The most recent Section 3 human health risk assessment for pendimethalin is Pendimethalin.  Human Health Risk Assessment for the Proposed Tolerance in/on Crayfish. (D350493; Christine L. Olinger; 31 March 2008).  Because details may be found in the above document, only summary information regarding pendimethalin hazard characterization and toxicity endpoints are included below in support of this Section 18 request.  Generally, information and/or conclusions which remain unchanged from the previous risk assessment are not reiterated; instead, a reference to the previous document is provided.

	Inter-regional Research Project #4 (IR-4) has conducted 8 field trials with pendamethalin on Bermuda grass (2 each in NC, TN, GA and TX), and submitted summarized preliminary results in support of TDA’s petition for a Section 18 registration.  HED has no objection to the establishment (associated with Section 18 registration) of tolerances for pendimethalin residues of 25 ppm in Bermuda grass forage, and 60 ppm in Bermuda grass hay.

	Environmental Justice Considerations

	Potential areas of environmental justice concerns, to the extent possible, were considered for this human health risk assessment, in accordance with US Executive Order 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (  HYPERLINK "http://www.epa.gov/compliance/resources/policies/ej/exec_order_12898.pd f"  http://www.epa.gov/compliance/resources/policies/ej/exec_order_12898.pdf ).

	As a part of every pesticide risk assessment, OPP considers a large variety of consumer subgroups according to well-established procedures.  In line with OPP policy, HED estimates risks to population subgroups from pesticide exposures that are based on patterns of that subgroup’s food and water consumption, and activities in and around the home that involve pesticide use in a residential setting.  Extensive data on food consumption patterns are compiled by USDA under the Continuing Survey of Food Intake by Individuals (CSFII), and are used in pesticide risk assessments for all registered food uses of a pesticide.  These data are analyzed and categorized by subgroups based on age, season of the year, ethnic group, and region of the country.  Additionally, OPP is able to assess dietary exposure to smaller, specialized subgroups and exposure assessments are performed when conditions or circumstances warrant.  Whenever appropriate, non-dietary exposures based on home use of pesticide products, and the associated risks for adult applicators, and for toddlers, youths, and adults entering or playing on treated areas post-application are evaluated.  Further considerations are currently in development as OPP has committed resources and expertise to the development of specialized software and models that consider exposure to bystanders and farm workers, as well as lifestyle and traditional dietary patterns among specific subgroups.

	Review of Human Research

	This risk assessment relies in part on data from studies in which adult human subjects were intentionally exposed to a pesticide or other chemical.  These studies (listed in Appendix B) have been determined to require a review of their ethical conduct, have received that review, and have been determined to be ethical.

2.0	ACTION REQUESTED

	The State of Texas Department of Agriculture (TDA) is employing a crisis exemption for the immediate use of the herbicide pendimethalin (as Prowl H20) on Bermuda grass pastures and hay fields as a treatment to control pre-emergent sandbur species in the State of Texas.  Prowl H20 is an aqueous capsule suspension (CS) formulation.  TDA is requesting a Section 18 registration for this use.  The request entails application of an estimated 7.9 million gallons of product (30 million lbs ai) to 10 million acres in Texas beginning 5 February 2008.  Human exposures and risks are addressed in this document for chronic dietary risk; exposure to and risk from pendimethalin residues in water; residential exposure and risk; aggregate exposure and risk; and exposure and risk to workers.

3.0	BACKGROUND

	Overview

	TDA has issued a crisis exemption that authorizes the use of pendimethalin, with CAS name N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine, to control common sandbur and other sandbur species (Cenchrus echinatus, et al) in Bermuda grass pastures and hay fields in Texas.  The crisis program entails application of the end-use product (EP), Prowl H20 (EPA Registration Number 241-418), on a maximum of 10 million acres in the State of Texas.  The counties of Texas affected by this crisis exemption include all counties throughout the state.  Prowl H20 may be applied once per crop season, by ground equipment only, at the rate of 2.0 to 3.0 pounds of active ingredient per acre (lb ai/A), which is equivalent to 2.1 to 3.2 quarts of product per acre.  Application via aerial or chemigation equipment is prohibited.  The maximum application rate is 3.0 lb ai/A (3.2 quarts) per season, and the minimum pre-harvest interval (PHI) is 40 days.  The use period for the crisis exemption commenced 5 February 2008.  This HED human health risk assessment is intended to cover the crisis exemption, as well as a request for the same use under Section 18 for the remainder of the season.

	There are currently established tolerances for residues of pendimethalin in many agricultural commodities, ranging from 0.10 ppm (in multiple crops) to 4.0 ppm (in alfalfa hay), as cited in 40CFR §180.361.  In addition to the establishment of tolerances for pendimethalin residues in Bermuda grass forage and hay pursuant to this Section 18 petition, there was the possibility that tolerances would be necessary in cattle meat and milk.  However, the results of a 29-day cattle feeding study (MRID #46591234) showed that pendimethalin residues were not detected in either milk or tissues from cows which received the 100-ppm dose level.  The highest pendimethalin residues from IR-4's Texas field trials on Bermuda grass were about 13 ppm at PHIs of 30 ± 2 days (in both forage and hay).  Since the previously calculated theoretical dietary burden (TDB) to beef and dairy cattle was roughly 5 ppm, summing this with the maximum residues from the Texas Bermuda grass field trials results in a TDB of approximately 18 ppm.  This estimated TDB (in light of the fact that residues at the proposed PHI of 40 days should be substantially lower than those seen at 30 days) indicates that there should be no likelihood of quantifiable pendimethalin residues appearing in either milk or beef tissues arising from grazing and/or feeding of treated bermuda grass and/or hay to livestock.  Therefore, there is no need to establish tolerances for pendamethalin in livestock commodities.

	There are currently no Codex maximum residue limits (MRLs) for pendimethalin.  Mexico has established MRLs (expressed as pendimethalin per se) for several crops, but not on Bermuda grass.  No Canadian MRLs have been established for pendimethalin.

	Occupational handler risks (MOEs) from the proposed use are all above 30, and do not cause concern to HED.  Because dermal exposure to post-application workers is not expected for pendimethalin, occupational post-application risks were not assessed.

	Residential exposures are possible from pendimethalin products used on lawns.  Residential post-application exposures were estimated for adults and children, and all result in risks that are not of concern to HED.

	Risk estimates associated with chronic dietary (food plus drinking water) exposure to pendimethalin are significantly below HED’s level of concern (LOC).  When dietary exposures are aggregated with residential exposures, the resulting estimates of risk are not of concern, either.

	Hazard Characterization and Assessment

	The database adequately characterizes pendimethalin as having low acute oral, dermal and inhalation toxicity.  It is Toxicity Category IV for acute dermal toxicity, acute inhalation toxicity, and primary dermal irritation; Toxicity Category III for acute oral and primary eye irritation; and it is not a dermal sensitizer.

	The thyroid is a target organ for pendimethalin.  Thyroid toxicity in chronic and subchronic rat and mouse studies was manifested as alterations in thyroid hormones (decreased Total T4 and T3, increased percent of free T4 and T3), increased thyroid weight, and microscopic thyroid lesions (including increased thyroid follicular cell height, follicular cell hyperplasia, and follicular cell adenomas).

	The toxicology database for pendimethalin is complete with regard to pre-natal developmental toxicity in rats and rabbits.  The data provided no indication of increased susceptibility following pre- or post-natal exposure in the two-generation reproduction study in rats.

	For detailed information, please refer to D350493; Christine L. Olinger; 31 March 2008.

	A summary of the LOCs for risk assessment is listed in Table 1 (below), while the toxicological doses and hazard endpoints selected are summarized in Table 2 (below).  The acute toxicity profile and the subchronic/chronic toxicity profile for pendimethalin are provided in the appendices.

Table 1	Summary of Levels of Concern (LOCs) for Risk Assessment.

Route of Exposure	Duration of Exposure

	Short-Term

(1-30 Days)	Intermediate-Term

(1-6 Months)	Long-Term

(>6 Months)

Residential Exposure

Dermal	300	300	300

Inhalation	300	300	300

Incidental Oral	300	300	NA*

Occupational Exposure

Dermal	30	30	30

Inhalation	30	30	30

Incidental Oral	30	30	NA

* NA = Not Applicable.

	FQPA Safety Factor

	Hormonal changes (alterations in thyroid weights, and histopathologic lesions) were observed in several studies following oral administration of pendimethalin, and it is likely that these changes may cause disruption in the endocrine system.  There is concern that perturbation of thyroid homeostasis may lead to hypothyroidism, and possibly result in adverse effects on the developing nervous system.  Consequently, HED has recommended that a developmental thyroid assay be conducted to evaluate the impact of pendimethalin on thyroid hormones, structure, and/or thyroid hormone homeostasis during development.  Furthermore, HED has recommended that a 10X database uncertainty factor (UFDB) be retained pending receipt of the study for non-occupational exposure scenarios.

	The standard 10X intraspecies uncertainty factor, and 3X interspecies factor are applicable to pendimethalin risk assessments.  The interspecies uncertainty factor of 10X was reduced to 3X due to the greater sensitivity of adult rats to thyroid effects compared to adult humans.  Because of toxicodynamic differences in adult thyroid function that result in greater sensitivity of the adult rat to hypothyroidism compared to adult humans, the 3X (3.16) toxicodynamic part of the 10X can be removed leaving the 3X (3.16) portion for toxicokinetic interspecies differences (Interim Guidance on Thyroid Disrupting Pesticides, 1 November 2005).  Thus, the usual 100X uncertainty factor for intra- and interspecies differences is reduced to 30X.  The 10X database uncertainty factor (UFDB) was retained pending submission of the developmental thyroid toxicity study.  Therefore, the level of concern (target MOE) for occupational exposure is 30 and the level of concern for residential exposure is 300.

	The 10X FQPA Safety Factor has been reduced to 1X, because thyroid effects serve as the basis for endpoint selection for pendimethalin risk assessment, since there were no developmental effects observed in the rat and rabbit developmental toxicity studies, and since the 10X UFDB has been retained for the lack of data on the developing thyroid.

  SEQ CHAPTER \h \r 1 TABLE 2	Toxicological Doses and Endpoints for Pendimethalin Human Health Risk Assessments.

Exposure

Scenario	Point of Departure 	Dose Used in Risk Assessment, UF	FQPA SF and Level of Concern for Risk Assessment	Study and Toxicological Effects

Dietary Exposure

Acute Dietary

(females 13-49)

(general US population)	NA	No appropriate acute endpoint identified for these groups.  There were no toxic effects attributable to a single dose.

Chronic Dietary

(all populations)	NOAEL = 10 mg/kg/day

Chronic RfD = 0.03 mg/kg/day	UFH = 10X

UFA = 3X

UFDB = 10X

Total UF = 300X	FQPA SF = 1X

cPAD = Chronic RfD

              FQPA SF

cPAD = 0.03 mg/kg/day	92-day thyroid function study in rats; 56-day thyroid study in rats; 14-day intra thyroid metabolism study in rats.

LOAEL= 31 mg/kg/day based on hormonal and histopathological changes in the thyroid.

Incidental Oral Exposure

Incidental Oral Short-Term

(1-30 days)

Intermediate-Term

(1-6 months)	NOAEL = 10 mg/kg/day	UFH = 10X

UFA = 3X

UFDB  = 10X

Total UF = 300X

	FQPA SF = 1X

Residential LOC = 300

Occupational LOC = 30	(Same as for chronic dietary.)

Dermal Exposure

Dermal

Short-Term

(1-30 days)

Intermediate-Term

(1-6 months)

Long-Term

(>6 months)	NOAEL = 10 mg/kg/day	UFH = 10X

UFA = 3X

UFDB  = 10X

Dermal Absorption = 3%	FQPA SF = 10X

Residential LOC = 300

Occupational LOC = 30	(Same as for chronic dietary.)

Inhalation Exposure

Inhalation

Short-Term

(1-30 days)

Intermediate-Term

(1 - 6 months)

Long-Term

(>6 months)	NOAEL = 10 mg/kg/day	UFH = 10X

UFA = 3X

UFDB  = 10X

Inhalation Absorption = 100% (equivalent to oral toxicity)	FQPA SF = 10X

Residential LOC = 300

Occupational LOC = 30	(Same as for chronic dietary.)

Cancer

Cancer (oral, dermal, inhalation)	Pendimethalin is considered to be a possible human carcinogen; the chronic dietary assessment using the cPAD is considered to be protective of cancer effects.  	2-year chronic/carcinogenicity study in rats.

Point of Departure (POD) = a data point or estimated point derived from observed dose-response data, which is used 	to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant 	human exposures.

  SEQ CHAPTER \h \r 1 UF = Uncertainty Factor.

UFA = extrapolation from animal to human (interspecies).

UFH = potential variation in sensitivity among members of the human population (intraspecies).

UFDB = to account for the absence of key data (such as the lack of a critical study).

FQPA SF = FQPA Safety Factor.

NOAEL = No Observed Adverse Effect Level.

LOAEL = Lowest Observed Adverse Effect Level.

PAD = Population Adjusted Dose (a = acute, c = chronic).

RfD = Reference Dose.

MOE = Margin Of Exposure.

LOC = Level Of Concern.

NA = Not Applicable.

	Dietary Exposure and Risk from Food and Drinking Water

	For detailed information, please refer to the dietary exposure assessment memorandum Pendimethalin:  Chronic Dietary (Food and Drinking Water) Analysis and Risk Assessment to Support a Tolerance in/on Crayfish (D350492; Christine L. Olinger; 31 March 2008).

	No acute endpoint was identified for pendimethalin, so a quantitative assessment of acute dietary risk was not conducted.

	A chronic dietary risk assessment was conducted using the Dietary Exposure Evaluation Model (DEEM-FCID™, Version 2.03) which uses food consumption data from the US Department of Agriculture’s Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994 to 1996, and 1998.  The analysis was performed to support the proposed tolerance in/on crayfish.  The chronic dietary exposure analysis was based on the following assumptions:

(1) tolerance-level residues of pendimethalin in/on all current 				raw agricultural commodities (RACs) in CFR40 §180.361, 				updated 16 November 2007) and proposed RACs;

(2) empirical processing factors obtained from processing studies;

(3) a maximum theoretical concentration factor of 8.0 for wheat 				bran and wheat germ, and 1.4 for wheat flour;

(4) DEEM 7.81 default processing factors were used for the 				remaining processed commodities;

(5) 100% crop treated (CT); and

(6) 0.006 ppm pendimethalin estimated drinking water 					concentration (EDWC).

The EDWC of 0.006 ppm (the 1 in 10 year annual mean concentration in surface water, as calculated by PRZM-EXAMS modeling) was directly entered into the exposure model to assess the contributions from drinking water.  This EDWC (resulting from a single application of pendimethalin to grapes in NY, at the rate of 6.0 lb ai/A) was the highest modeling result calculated for either surface or groundwater sources of drinking water, and is therefore conservative.

	These assumptions result in conservative estimates of dietary exposure and risk.  In calculating dietary risk estimates, HED has compared the cPAD to the estimated dietary exposure.  Typically, HED has concerns regarding dietary risk when the exposure estimates exceed 100% of the cPAD.  Even with the conservative assumptions noted above, risk estimates associated with chronic dietary exposure to pendimethalin are significantly below HED’s LOC.

	From the chronic dietary assessment, the most highly exposed population subgroup is children 1-2 years old.  The chronic exposure estimate, 0.004582 mg/kg/day, corresponds to approximately 15% of the cPAD.  The risk estimate for the general US population is below HED’s LOC, as the exposure (0.001526 mg/kg/day) utilizes 5% of the cPAD.  A summary of the chronic dietary (food and water) exposure and risk estimates may be found in Table 3, below.

	The HED Cancer Peer Review Committee classified pendimethalin as a possible human carcinogen, based on thyroid follicular cell adenomas in rats.  The chronic dietary risk assessment is considered to be protective of any cancer effects; therefore, a separate quantitative cancer dietary risk assessment is not required.

Table 3	Summary of Chronic Dietary Exposure and Risk Estimates for Pendimethalin.

Population Subgroup*

[Years of Age]	DEEM Chronic Dietary Analysis – Food and Drinking Water

	cPAD (mg/kg/day)	Exposure Estimate (mg/kg/day)	% cPAD

General US Population	0.03	0.001526	5

All Infants [<1]	0.03	0.003037	10

Children [1-2]	0.03	0.004582	15

Children [3-5]	0.03	0.003724	12

Children [6-12]	0.03	0.002271	8

Youths [13-19]	0.03	0.001404	5

Adults [20-49]	0.03	0.001157	4

Adults [50+]	0.03	0.001053	4

Females [13-49]	0.03	0.001155	4

* Values for the population with the highest risk are in bold type.

	Residential Exposure and Risk

	This residential exposure and risk assessment for pendimethalin is based on the previous assessment (D325175; Margarita Collantes, Zaida Figueroa; 2 April 2007).  In the previous assessment, dermal and oral post-application exposures to residential turf were evaluated.  Inhalation post-application was not assessed because there are no indoor residential uses associated with pendimethalin products, and inhalation exposure resulting from outdoor uses is expected to be negligible.  A residential handler exposure assessment for applying pendimethalin to residential turf was not performed because all turf labels appear to be for commercial use only.  The dermal assessment performed in the previous work included two scenarios:

(1) children’s short-term dermal exposure to residential turf; and

(2) adult’s short-term dermal exposure to residential turf.

The oral assessment included three scenarios:

(1) children's oral exposure from hand-to-mouth ingestion;

(2) children's oral exposure from object-to-mouth; and

(3) children's oral exposure from soil ingestion.

Results of the previous assessment are summarized below.

Dermal post-application exposure and risk:  The LOC for non-occupational dermal exposure is an MOE of less than 300.  Using the turf transferable residues (TTR) data for the Pendulum WDG formulation, children’s short-term dermal MOEs (calculated with the use rate on Bermuda grass of 3.0 lb ai/A) ranged from 440 to 910 (see Table 4, below).  For adults, short-term dermal MOEs ranged from 740 to 1500 (see Table 5, below).  All dermal short-term MOEs are greater than 300, and therefore do not exceed HED’s LOC.

Table 4	Children’s Short-Term Dermal Post-Application Exposure to Pendimethalin.

State	TTR 1 (µg/cm2)	(mg/µg)	TC 2 (cm2/hr)	ET 3 (hrs)	Dermal Absorption 	BW 4 (kg)	Daily Dose 5 (mg/kg/day)	NOAEL (mg/kg/day)	MOE 6

CA	1.1	0.001	5200	2	0.03	15	0.0228	10	440

PA	0.756

0.0157

640

FL	0.538

0.011

910

1. TTR = Turf Transferable Residues, based on Pendulum WDG TTR study (MRID #44969901).

2. TC = Transfer Coefficient, based on HED Residential SOPs.

3. ET = Exposure Time, based on HED Residential SOPs.

4. BW = Body Weight.

5. Dose = [TTR (ug/cm2) x 0.001 (mg/ug) x TC (cm2/hr) x ET (hrs/day) x dermal absorption] ÷ BW.

6. Dermal MOE = [Short-term NOAEL (10 mg/kg/day)] ÷ Daily Dose.

Table 5	Adult’s Short-Term Dermal Post-Application Exposure to Pendimethalin.

State	TTR 1 (µg/cm2)

(mg/µg)	TC 2 (cm2/hr)	ET 3 (hrs)	Dermal Absorption	BW 4 (kg)	Dose 5 (mg/kg/day)	NOAEL (mg/kg/day)	MOE 6

CA	1.1	0.001	14500	2	0.03	70	0.0136	10	740

PA	0.756

0.009

1100

FL	0.538

0.00668

1500

1. TTR = Turf Transferable Residues, based on Pendulum WDG TTR study (MRID #44969901).

2. TC = Transfer Coefficient, based on HED Residential SOPs.

3. ET = Exposure Time, based on HED Residential SOPs.

4. BW = Body Weight.

5. Dose = [TTR (ug/cm2) x 0.001 (mg/ug) x TC (cm2/hr) x ET (hrs/day) x dermal absorption] ÷ BW.

6. Dermal MOE = [Short-term NOAEL (10 mg/kg/day)] ÷ Daily Dose.

	Oral post-application exposure and risk:  The LOC for non-occupational oral exposure is an MOE of less than 300.  All oral MOEs (hand-to-mouth, object-to-mouth, and soil ingestion) were greater than 300, and therefore are not of concern to HED.  The MOEs calculated for hand-to-mouth exposures using the rate of 2.0 lb ai/A resulted in an MOE of 7,700.  The MOEs for object-to-mouth and soil ingestion exposure were 130,000 and 100,000 respectively.  MOEs calculated for hand-to-mouth exposures using the rate of 3.0 lb ai/A resulted in an MOE of 5,300.  The MOEs for object-to-mouth and soil ingestion exposure were 85,000 and 67,000 respectively.  Calculations and MOEs are summarized in Table 6, below.

	Ingestion of pendimethalin granules is also a potential source of exposure because children can eat them if they are found in treated lawns or gardens.  This scenario is considered an episodic scenario by the Agency (acute oral endpoints would be used to estimate the risk).  A risk assessment for this exposure scenario for children was not conducted since an acute oral toxicological endpoint of concern was not identified for this pesticide.

	Aggregate residential exposure:  An aggregate exposure estimate for adults (consisting of dermal exposure only) resulted in a total MOE of 740 (see Table 7, below), which is greater than the LOC of 300, and therefore not of concern to HED.  The adult total MOE of 740 was based on using the TTR from the California test site, and a 3% dermal absorption factor.  Since the California test site resulted in the lowest dermal MOE, it was determined to represent the worst case scenario.  In assessing the aggregate residential exposure for children, HED also used the California TTR data, hand press data, and a 3% dermal absorption factor for determining dermal exposure to children.  This resulted in a total MOE (dermal + oral) of 410 for an application rate of 2 lb ai/acre, or 400 for an application rate of 3 lb ai/acre (see Table 7), which is greater than 300, and therefore not of concern.

Table 6	Oral Post-Application Exposure to Pendimethalin.

Rate

(lb ai/A)	SR 1	TTR 2 (µg/cm2)	Grt 2 (µg/cm2)	Srt 2 (µg/g)	(mg/µg) or (g/ug)	SA (cm2/event)	IgR (cm2/day) or (mg/day)	FQ (events/

hr)	SEF	ET (hrs)	BW (kg)	Dose b (mg/kg/day) 	MOE

Hand-to-Mouth 3

2.0	22.4	0.049 a	NA*	NA	1E-3	20	NA	20	0.5	2	15	0.0013	7,700

3.0	33.6	0.74 a

0.0019	5,300

Object-to-Mouth 4

2.0	NA	NA	0.0471 a	NA	1E-3	NA	25	NA	NA	NA	15	0.0000785	130,000

3.0

	0.07 a

	0.0001178	85,000

Soil Ingestion 5

2.0	NA	NA	NA	15 a	1E-6	NA	100	NA	NA	NA	15	0.0001	100,000

3.0

22.5 a

0.00015	67,000

Total Oral Dose 6 and MOE 7

2.0

0.001479	6,800

3.0

0.00217	4,600

1. SR = Surface Residue = 2 (3) lb ai/A x 11.2 = 22.4 (33.6).

2. TTR, Grt and Srt values are cited from ORE memo for pendimethalin (D270528; Steven Weiss; 16 August 2001).

3a. TTR = application rate (2 lb ai/A) x conversion factor (11.22 µg/cm2) x %transferability (0.0022) for gauze wipe.

3b. Hand-to-mouth dose = [TTR t (ug/cm2) x SA (cm2/event) x SEF x FQ (events/hr) x 1.0E-3 mg/ug x ET (hrs/day)] ÷ Body Weight (kg).

4a. GRt = application rate (2 lb ai/A) x (11.22 µg/cm2) x %transferability (0.0021) aerosol OT solution sample.

4b. Object-to-mouth dose = [GR t (ug/cm2) x IgR (cm2/day) x 1.0E-3 mg/ug] ÷ Body Weight (kg).

5a. Srt = application rate (2 lb ai/A) x (11.22 µg/cm2) x %transferability (1.0) x 0.67 cm2/g soil.

5b. Soil ingestion dose t = [SR t (ug/g) x IgR (100 mg/day) x CF1 (10-3 g/mg) x (10-3 mg/ug)] ÷ Body Weight (kg).

6. Total dose = hand-to-mouth dose + object-to-mouth dose + soil ingestion dose.

7. Total oral MOE = 1/[(1/hand-to-mouth MOE) + (1/object-to-mouth MOE) + (1/soil ingestion MOE)] =

	[NOAEL (10 mg/kg/day)] ÷ [hand-to-mouth dose + object-to mouth dose + soil ingestion dose].

* NA = Not Applicable.

Table 7	Aggregate Risk Resulting from Residential Exposure to Pendimethalin.

Exposure Scenario	Population	TTR (ug/cm2) 1	Dermal Dose 2 (mg/kg/day) Dermal MOE 3

	Inhalation MOE	Total Oral Dose4 (mg/kg/day)	Oral

MOE 5	Total Dose	Total MOE 6

Turf Grass	Adults	1.1 	0.0136 a	740 	NA 7	NA	NA	0.0136	740

	Children

0.0228 b	440	NA	0.0015	6800	0.0243	410

0.0022	4600	0.025	400

1. TTR values are based on Pendulum WDG TTR study (MRID #44969901).

2a. See Table 5.

2b. See Table 4.

3. Dermal MOE = average of dermal MOEs for adults and children calculated from TTR data from CA, PA and FL (see Tables 4 and 5).

4. Total oral dose = hand-to-mouth dose + object-to-mouth dose + soil ingestion dose (see Table 6).

5. Oral MOE = [NOAEL (10 mg/kg/day)] ÷ [hand-to-mouth dose + object-to mouth dose + soil ingestion dose].

6. Total MOE = 1/[(1/dermal MOE) + (1/oral MOE)] = [NOAEL (10 mg/kg/day)] ÷ [Dermal Dose + Total Oral Dose].

7. NA = Not Applicable.

	Occupational Exposure and Risk

	The proposed Section 18 emergency exemption requests the use of Prowl H20 herbicide, which is a CS formulation (3.8 lb ai/gal), to control sandbur species in Bermuda grass pastures and hay fields in Texas.  The product will be applied (at a rate of 2.0 to 3.0 lb ai/A) by ground equipment during winter dormancy, or in the spring prior to green-up.  According to TDA, only one application per season will be made, and the application shall not exceed 3.0 lb ai/A per crop season.

	Handlers:  HED has determined that exposure to pesticide handlers is likely during the occupational use of pendimethalin.  There are 2 handler scenarios that are expected to result in the highest exposure for the proposed use:

(1) Mixing/Loading Liquids for Ground Application; and

(2) Applying Sprays Using Ground-Boom.

The HED occupational LOC is an MOE of less than 30.  No MOEs for handlers exceed the LOC at the single layer level (MOE for mixer/loader = 33, and MOE for applicator = 2,600).  Single layer consists of long-sleeve shirt and long pants (or coveralls), and no respirator.  Because the MOE for mixers/loaders is so close to the LOC, an assessment of risk for mixers/loaders with single layer plus gloves was conducted.  For this scenario, the mixer/loader MOE was 1500.  A summary of the exposures and risks for handlers is presented in Table 8, below.

	The handler exposure estimates in this assessment are based on a central tendency estimate of unit exposure, and an upper-percentile assumption for the application rate, and are assumed to be representative of high-end exposures.  The uncertainties associated with this assessment stem from the use of surrogate exposure data (differences in use scenario, and data confidence), and assumptions regarding the amount of chemical handled.  The estimated exposures are believed to be reasonable high-end estimates, based on observations from field studies, and professional judgement.

	Post-application:  The post-application exposure and risk assessment is not required because the application is made direct to the soil (the product must be applied using a low boom), and the application is made during winter dormancy, or in the spring prior to green-up.  Dermal exposure to post-application workers is not expected under these conditions.

	The technical material has a Toxicity Category IV for skin irritation and acute dermal toxicity, and a Category III for eye irritation.  Per the Worker Protection Standard (WPS), a 12-hour restricted entry interval (REI) is required.  The 24-hour REI appearing on the label is adequate.

Table 8	Non-Cancer Occupational Risks for Pendimethalin Handlers.

Exposure Scenario	Mitigation Level 1	Dermal Unit Exposure 2 (mg/lb ai) Inhalation Unit Exposure 3   (ug/lb ai)	Use Rate

(lb ai/A)	Acres Treated 4

(A/day)	Daily

Dermal

Dose 5 (mg/kg/day)	Daily

Inhalation

Dose 6 (mg/kg/day)	Combined Daily Dose 7 (mg/kg/day)	Total

MOE 8

Mixer/Loader

Mixing/Loading       Liquids for Ground Application	Single Layer

(No Gloves)	2.9	1.2	3	80	0.2983	0.0041	0.3024	33

	Single Layer

Plus Gloves	0.023	1.2	3	80	0.0024	0.0041	0.0065	1,500

Applicator

Applying Sprays Using

Ground-Boom	Single Layer

(No Gloves)	0.014	0.74	3	80	0.0014	0.0025	0.0039	2,600

1. Single layer = long-sleeve shirt + long pants or coveralls, and no respirator.

2. Dermal unit exposure represents long pants and long-sleeved shirt, with either no gloves or plus gloves.

3. Inhalation unit exposure represents no respiratory protection, open mixing, loading, applying.

4. Daily acres treated values are EPA estimates of area that could be treated per day for each exposure scenario of concern (ExpoSAC Policy 9, 5 July 2000).

5. Daily dermal dose (mg/kg/day) = [unit dermal exposure (mg/lb ai) x application rate (lb ai/A) x DA (0.03) x daily acres treated] ÷ body weight (70kg).

6. Daily inhalation dose (mg/kg/day) = [unit exposure (µg/lb ai) x (1mg/1000 µg) conversion x use rate (lb ai/A) x daily acres treated] ÷ body weight (70kg).

7. Combined daily dose = daily dermal dose (mg/kg/day) + daily inhalation dose (mg/kg/day).

8. Total MOE = NOAEL (10 mg/kg/d) ÷ combined daily dose.

	Residue Chemistry and Tolerance Assessment

	There are currently no Codex maximum residue limits (MRLs) for pendimethalin.  Mexico has established MRLs (expressed as pendimethalin per se) for several crops, but not on Bermuda grass.  No Canadian MRLs have been established for pendimethalin.

	Residue analytical methods:  Adequate methods are available for tolerance enforcement.    SEQ CHAPTER \h \r 1 Methods I through IV in the Pesticide Analytical Manual (PAM) Volume II are gas chromatography with electron capture detection (GC/ECD) methods with LOQs of 0.05 ppm each for the parent and its 3,5-dinitrobenzyl alcohol metabolite (both of which are included in the tolerance expression).  Currently, all pendimethalin tolerances for RACs are established at the combined LOQ of 0.1 ppm.  A confirmatory GC with mass spectrometry detection (GC/MS) method has been submitted (with a petition on carrots), and has been found adequate to determine residues of pendimethalin and its 3,5-dinitrobenzyl alcohol metabolite.

	Crop field trials:  IR-4 has conducted field trials with pendamethalin on Bermuda grass, and submitted summarized preliminary results in support of TDA’s petition for a Section 18 registration.  Residues in forage and hay were determined at 5 PHIs (30, 35, 40, 45, and 50 days).  Because the proposed PHI is 40 days, only residue data from samples harvested at this PHI were entered into the tolerance spreadsheet to determine the recommended tolerances.  The spreadsheet results recommend tolerances for pendimethalin residues of 25 ppm in Bermuda grass forage, and 60 ppm in Bermuda grass hay.

FIGURE 1	Bermuda Grass Forage

		y = 1.4151x - 0.2426				R2 = 0.9196

FIGURE 2	Bermuda Grass Forage

FIGURE 3	Bermuda Grass Hay

		y = 1.5465x + 0.4923				R2 = 0.9532

FIGURE 4	Bermuda Grass Hay

4.0	REFERENCES

Risk Assessment Memorandum

	Pendimethalin.  Human Health Risk Assessment for the Proposed Tolerance in/on Crayfish.; D350493; Christine L. Olinger; 31 March 2008.

Dietary Exposure Memorandum

	Pendimethalin:  Chronic Dietary (Food and Drinking Water) Analysis and Risk Assessment to Support a Tolerance in/on Crayfish; D350492; Christine L. Olinger; 31 March 2008.

Occupational and Residential Exposure Memorandum

	Pendimethalin: REVISED Occupational and Residential Exposure Assessment for Proposed Section 3 Registration for Use on Mint, Citrus Fruits, Tree Nuts, and Carrots.; D325175; Margarita Collantes, Zaida Figueroa; 2 April 2007.

AppendiX A:  Toxicology Assessment

Toxicity Profiles TC \l2 "A.2  Toxicity Profiles

Table A.1	Acute Toxicity Profile for Pendimethalin.

Guideline Number	Study Type	MRID Number	Results	Toxicity Category

870.1100	Acute oral [Rat]	00026657	LD50=1250 mg/kg (m)

        =1050 mg/kg (f)	III

870.1200	Acute dermal [Rabbit]	00026657	LD50 = >5000 mg/kg	IV

870.1300	Acute inhalation [Rat]	00073342	LC50 = 32 mg/L	IV

870.2400	Acute eye irritation [Rabbit]	00026657	Slight conjunctival irritation.	III

870.2500	Acute dermal irritation [Rabbit]	00026657	No dermal irritation. IV

870.2600	Skin sensitization [Guinea pig ]	00153767	Non-sensitizer.	NA*

* NA = Not Applicable.

Table A.2	Subchronic, Chronic and Other Toxicity Profile for Pendimethalin.

Guideline Number	Study Type	MRID Number & Classification	Dose Levels Results

870.3100	Subchronic oral [Rat] (30-day)	000106754 Supplementary	ppm = 0, 800, 1600, 3200

mg/kg/day =

0, 80, 160, 320	NOAEL = 160 mg/kg/day.

LOAEL = 320 mg/kg/day, based on increased liver weight.

870.3100	Subchronic oral [Rat] (13-week)	00156081	ppm = 0, 100, 500, 5000

mg/kg/day =

 0, 10, 50, 500	NOAEL = 50 mg/kg/day.

LOAEL = 500 mg/kg/day, based on decreased body weight gain and food consumption, decreased hematocrit and hemoglobin with increases in platelets in males, increased liver weight, red thyroids, and hypertrophy of the liver.

870.3100	Subchronic oral [Rat] (13-week)	00059468

Supplementary	ppm = 0, 25, 50, 100, 500, 2500

mg/kg/day =

0, 2.5, 5, 10, 50,  250	NOAEL = 250 mg/kg/day.

LOAEL was not determined.

870.3100	Subchronic oral [Rat] (13 week)	00059469

Supplementary	ppm = 0, 2500

mg/kg/day = 0, 250	NOAEL = 250 mg/kg/day.

LOAEL was not determined.

870.3100	Subchronic oral [Rat] (92-day)	42054601	ppm = 0, 100, 5000

mg/kg/day =

0, 4.98, 245.4	NOAEL = 4.98 mg/kg/day.

LOAEL = 245.4 mg/kg/day, based on thyroid effects.

870.3100	Subchronic oral [Rat] (56-day)	43135001	ppm = 0, 500, 5000

mg/kg/day =

0, 31, 292	NOAEL was not determined.

LOAEL = 31 mg/kg/day, based on thyroid effects.

870.3100	Subchronic oral [Rat] (14-day)	43135003	ppm = 0, 100, 500

mg/kg/day =

0, 10, 500	NOAEL = 10 mg/kg/day.

LOAEL = 500 mg/kg/day, based on thyroid effects.

870.3100	Subchronic oral [Dog] (90-day)	00026672

Supplementary	mg/kg/day =

0, 62.5, 250, 1000	NOAEL = 62.5 mg/kg/day.

LOAEL = 250 mg/kg/day, based on body weight loss.

870.3150	Subchronic oral [Mouse] (30-day)	000106754

Supplementary	ppm = 0, 500, 1000, 2000

mg/kg/day =

0, 75, 150, 300	NOAEL = 300 mg/kg/day.

LOAEL was not determined.

870.3200	21-Day dermal toxicity [Rat]	00026663	mg/kg/day =

0, 250, 500, 1000	NOAEL = 1000 mg/kg/day.

LOAEL was not determined.

870.3700a	Prenatal developmental toxicity [Rat]	00025752

Supplementary, but satisfactory when considered with the rabbit developmental.	mg/kg/day =

0, 125, 250, 500	Maternal NOAEL = 500 mg/kg/day (highest dose tested).

Developmental NOAEL = 500 mg/kg/day  (highest dose tested).

870.3700b

	Prenatal developmental toxicity [Rabbit)]	00117444

Supplementary, upgradeable.	mg/kg/day =

 0, 15, 30,  60	Maternal NOAEL = 60 mg/kg/day (highest dose tested).

Developmental NOAEL = 60 mg/kg/day (highest dose tested).

Note: a range finding study indicated doses ≥125 mg/kg/day associated with increased mortality.

870.3800	Reproduction and fertility effects [Rat]

(2-generation reproduction)	41725203

	ppm = 0, 500, 2500, 5000

mg/kg/day (M/F) =

0, 34/43, 172/216, 346/436

HED RED

mg/kg/day =

0, 25, 125, 250

HIARC Document

Note: Doses were obtained from an HED pendimethalin RED, and a HIARC document (4/18/2000) which resulted in different dose calculations for mg/kg/day.  Consequently, doses

are given as a range, based on calculations from actual chemical intake, and a generic ratio (1:20) of dietary intake.	Parental/Systemic NOAEL = 25-34/43 (M/F) mg/kg/day (500 ppm).

Parental /Systemic LOAEL = 125-172/216 (M/F) mg/kg/day (2500 ppm), based on decreased body weight gain and food consumption.

Reproductive/Offspring NOAEL = 25-34/43 (M/F) mg/kg/day (500 ppm).

Reproductive/Offspring LOAEL = 125-172/216 (M/F) mg/kg/day (2500 ppm), based on decreases in the number of pups born, and pup weights.

870.3800	Reproduction and fertility effects [Rat]

(3-generation reproduction)	00026671, 0040304, 00059470	ppm = 0, 500, 5000

mg/kg/day =

0, 25, 250	Parental/Systemic NOAEL = 25 mg/kg/day.

Parental/Systemic LOAEL = 250 mg/kg/day, based on decreased body weight.

Reproductive/Offspring NOAEL = 25 mg/kg/day.

Reproductive/Offspring LOAEL = 250 mg/kg/day, based on decreased pup body weight gain, and possible decreased pups born alive and pup survival.

870.4100a	Chronic toxicity

[Mouse]	40909901	ppm = 0, 100, 500, 5000

mg/kg/day (M/F) =

0, 12.3/15.6, 62.3/78.3, 622.1/806.9	NOAEL = 62.3/78.3 mg/kg/day.

LOAEL = 622.1/806.99 mg/kg/day, based on mortality, body weight decrease, organ weight changes, and amyloidosis.

870.4100b	Chronic toxicity [Dog] (2-year oral)	00058657	mg/kg/day =

0, 12.5, 50, 200	NOAEL = 200 mg/kg/day.

LOAEL was not established.

870.4200	Chronic toxicity/carcino-genicity [Rat]

(2-year oral)	40174401	ppm = 0, 100, 500, 5000

mg/kg/day =

0, 5, 25, 250	NOAEL = 25 mg/kg/day.

LOAEL = 250 mg/kg/day, based on decreased survival and body weight gain, decreased food consumption, increased gamma glutamyl transferase, cholesterol and liver weights, and thyroid effects.

870.4200	Chronic toxicity  [Rat] (2-year oral)	42027802	ppm = 0, 1250, 2500, 3750, 5000

mg/kg/day =

0, 51, 103, 154, 213	NOAEL was not determined.

LOAEL = 51 mg/kg/day, based on non-neoplastic thyroid follicular cell changes.

870.4300

	Carcinogenicity [Mouse] (18-month oral)	40909901	ppm = 0, 100, 500, 5000

mg/kg/day (M/F) =

0, 12.3/15.6, 62.3/78.3, 622.1/806.9	NOAEL = 62.3/78.3 mg/kg/day.

LOAEL = 622./806.9 mg/kg/day, based on mortality, body weight decrease, organ weight changes, and amyloidosis.

870.5100	Reverse gene mutation assay [Bacterial strains of S. typhimurium]	00153768	µg/plate = 50, 158, 500, 1581, 5000	Positive

Evidence of a 2-fold increase in the number of induced mutant colonies over background (at all doses from 50 to 5000 µg/plate).

870.5100	Reverse gene mutation assay [Escherichia coli WP2]	43177801 µg/plate = 25, 50, 100, 250, 500, 750	Negative

870.5100	Reverse gene mutation assay [Escherichia coli WP2]	43135005	50, 158, 500, 1581, 5000 µg/plate or 1000 µg/paper disk/plate 	Negative

870.5100	Reverse gene mutation assay [Escherichia coli WP2]	43135006 µg/plate = 50, 100, 250, 500, 750	Negative

870.5300	Mammalian cell gene mutation [Chinese hamster ovary]	43177802 µg/plate = 1, 5, 7.5, 10, 20, 30, 40, 50 (-S9)

µg/plate = 10, 25, 50, 75, 100, 125, 150, 175 (+S9)	Negative

870.5375	Chromosomal aberration [Chinese hamster ovary]	00153770	Doses ranging from 5-50 µg/ml	Negative

870.5395	Micronucleus study [Mouse]	42027801	mg/kg = 313, 625, 1250 Negative

870.5550	Alkaline elution assay [Rat]	43135007	mg/kg/bw = 1250, 2500, 5000	Negative

870.7485	Metabolism and pharmacokinetics [Rat]	00046275	NA* Pendimethalin is eliminated from the body within 24 hours, with 70% being excreted in feces (primarily the parent compound), and 20% in urine.

* NA = Not Applicable.

Note:  Some of the LOAELs/NOAELS were previously denoted as LOELs/NOELS in Data Evaluation Records 	(DERs).  The language was updated to comply with current standards without re-examining effects.  As 	new uses for pendimethalin are submitted, DERs will be re-reviewed and updated.

AppendiX B:  Human Research REFERENCE

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Page   PAGE  1  of   NUMPAGES  22


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    The Exchange also believes that the proposed Lock-in and Lock-out
Time is consistent with the protection of investors and the public
interest, because in the final minutes leading into the auction match,
the Exchange is attempting to achieve equilibrium and stability by
avoiding the increase of imbalances or large price swings resulting
from aggressively priced orders in the Auction Book, while still
allowing for price discovery to occur within the applicable auction
collars leading up to the auction match. The Exchange notes that that
Bats implements an identical Opening Auction Lock-out time (9:28 a.m.),
at which time LOO and MOO orders, as well as RHO orders will be
rejected. In the context of the IEX Opening Auction, such orders are
the equivalent of the order types on the Opening Auction Book.
Furthermore, Bats restricts Users from canceling or modifying Eligible
Auction Orders between the Lock-out Time and the auction match, except
for RHO limit orders, which may be modified (but not canceled) until
the auction match.\126\
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    \126\ See Bats Rule 11.23(b)(1)(A)-(B).
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    The Exchange is proposing to afford Users the ability to enter
auction specific interest (within the applicable auction collar) beyond
the typical cutoff times employed by other exchanges, while locking-in
such interest and beginning the dissemination of IEX Auction
Information using a time-line that will be familiar to Users.
Specifically, the proposed approach is

similar to Bats and Nasdaq,\127\ in applying a 9:28 a.m. Lock-out [sic]
\128\ Time for the Opening Auction, where LOO and MOO interest is no
longer accepted [sic] \129\ and may no longer be modified; however,
after informal discussion with various Members that have expressed
demand for a later cut off time, the Exchange is proposing that LOO
orders and limit orders with a time-in-force of DAY or GTX will
continue to be accepted until the Opening Auction Lock-out Time (i.e.,
9:29:50 a.m., ten (10) seconds prior to the Opening Auction match) so
long as they are not Hyper-aggressive Auction Orders, which will allows
Users to continue to express interest, and offset imbalances via orders
designated for the Auction Book in the minutes leading up to the
auction match. Similarly, for the Closing Auction, the Exchange is
proposing to apply a 3:50 p.m. Lock-out [sic] \130\ Time, where MOC
interest is no longer accepted and Auction Eligible Orders on the
Auction Book may no longer be modified or canceled, unless a user
requests cancelation of an order to correct a legitimate error in the
order prior to 3:55 p.m. Moreover, the Exchange is proposing that LOC
orders will continue to be accepted until the Closing Auction Lock-out
Time (i.e., 3:59:50 p.m., ten (10) seconds prior to the Closing Auction
match) so long as they are not Hyper-aggressive Auction Orders, which
will allows Users to continue to express interest, and offset
imbalances via orders designated for the Auction Book in the minutes
leading up to the auction match.\131\
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    \127\ See Nasdaq Rule 4702(b)(8)-(9) and (11)-(12).
    \128\ The Commission notes that, for opening auctions, IEX is
proposing a Lock-in (not Lock-out) time of 9:28 a.m. See proposed
Rule 11.350(a)(22) (defining ``Lock-in Time'').
    \129\ The Commission notes that, for opening auctions, IEX is
proposing to: (1) Accept LOO orders until the Lock-out time as long
as they are not Hyper-aggressive Auction Orders, and (2) not accept
MOO orders after the Lock-in Time.
    \130\ The Commission notes that, for closing auctions, IEX is
proposing a Lock-in (not Lock-out) time of 3:50 p.m. See proposed
Rule 11.350(a)(22) (defining ``Lock-in Time'').
    \131\ The Exchange notes that as explained by a recent study on
NYSE auctions conducted by Greenwich Associates, NYSE d-Quotes
(which can be entered by broker that have relationships with NYSE
floor brokers, or trading algorithms that are able to enter orders
directly via FIX) contribute a meaningful portion of closing auction
volume, as evidenced by the significant increase and fluctuations of
indicative volume taken as a percentage of realized volume in the
closing auction. Specifically, NYSE's auction data feed shows a
material spike in indicative volume at 3:55 p.m., when d-Quotes are
first included in the NYSE auction data feed, followed by
fluctuations in indicative volume as a percent of realized volume.
The Exchange further notes that the proposed handling of LOO, LOC,
and limit orders submitted after the Lock-in Time that are not
priced beyond the Opening/Closing Auction Collars is distinguishable
from NYSE d-Quotes in that d-Quotes can be entered at any price, and
can be canceled. As proposed, LOO, LOC, and limit orders submitted
after the Lock-in Time that are not priced beyond the Opening/
Closing Auction Collars cannot be canceled. The proposed order
handling and IEX Auction information dissemination is designed to
reflect ``locked-in'' interest on the Auction Book, which is
intended to stimulate price discovery, and reduce fluctuations
indicative volume taken as a percentage of realized volume that are
caused by Users canceling orders on the Auction Book. See Trading
the Auctions, Greenwich Associates, 2017, Doc ID 16-2068 (https://www.greenwich.com/equities/trading-auctions).
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    Furthermore, for both the Opening and Closing Auctions, Hyper-
aggressive Auction Orders will be rejected after the Lock-in Time,
which is designed to minimize the increase of imbalances or large price
swings resulting from aggressively priced orders in the Auction Book
during the last minutes leading into the auction. Instead, the Exchange
is proposing to allow for price discovery to occur on the Auction Book
within the applicable auction collars and on the Continuous Book
leading up to the auction match, allowing for a convergence of the
Auction Book with the Continuous Book to establish equilibrium. The
Exchange believes that allowing Users to offset imbalances on the
Auction Book after the Lock-in Time is designed to promote price
discovery and stability, and establish equilibrium leading into the
auction match because such orders are not able to be canceled or
modified after entry (i.e., they are locked-in), which is in direct
contrast with offsetting orders on the Continuous Book that may be
fleeting, because they are eligible for cancellation, modification, or
execution until the auction match.
    Furthermore, as described above, the Exchange believes that
allowing Auction Eligible Orders on the Continuous Book to continue to
be submitted, modified, and canceled until immediately prior to
execution is consistent with the protection of investors and the public
interest because such orders allow Users to offset imbalances in the
auction until the auction match occurs, which will further the
Exchange's intended goal of achieving equilibrium and stability prior
to the auction match. In addition, the Exchange does not propose to
interrupt continuous trading, and therefore believes it is necessary to
allow Continuous Book orders to remain unrestricted in the interest of
maintain fair and orderly markets, and the protection of investors and
the public interest. The Exchange also notes that Bats offers identical
functionality for all orders eligible for execution in the Bats Pre-
Opening Session.\132\ Similarly, NYSE Arca allows orders to enter the
Continuous Book after the Opening and Closing Auction Imbalance
Freeze.\133\ The Exchange does not believe that allowing orders to
enter the Continuous Book and be eligible for execution in the auction
match until immediately before the auction match presents any unique
concerns regarding manipulation of the auction match. To the contrary,
because the Exchange generally utilizes the Protected NBBO as the
Reference Price Range for the auction match (rather than the midpoint
of the IEX BBO), the auction process may be less susceptible to
attempted manipulation, because in order to influence the auction, one
or more Users would need to sweep the entire market and impact the
Protected NBBO, rather than simply entering aggressive interest on the
Exchange.
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    \132\ See Bats Rule 11.23(b)(1)(C).
    \133\ See Arca Rule (c)(3)(D) and (d)(2)(C) [sic].
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    The Exchange believes that providing transparent Opening Auction
Contingency Procedures is consistent with the protection of investors
and the public interest in that Users will have more clarity regarding
the status of open orders, therefore allowing for such Users to
resubmit such interest in the Regular Market Session, or re-route such
interest to an alternate trading center after IEX has opened the
security for trading. In addition, the Opening Auction Contingency
Procedures are designed to ensure the orderly and timely opening of
IEX-listed securities, which will help to ensure a fair and orderly
market for securities listed on the Exchange. Similarly, the Exchange
believes that the proposed Closing Auction Contingency Procedures are
designed to ensure the orderly and timely closing of IEX-listed
securities, which will help to ensure a fair and orderly market for
securities listed on the Exchange. Furthermore, the proposed Closing
Auction Contingency Procedures are identical to those recently proposed
by Nasdaq in conjunction with NYSE and NYSE Arca, and the SIPs as part
of a larger industry initiative to ensure the orderly execution and
dissemination of official closing prices. Accordingly, the Exchange
believes that the proposed auction contingency procedures are
consistent with the protection of investors and the public interest.
    The Exchange believes that the data elements proposed to be
included in IEX Auction Information will provide market participants
with a comprehensive range of data relevant to auction pricing that
will enable market participants to make informed decisions on whether
and at what prices to enter

orders for potential participation in an IEX Auction.\134\ The Exchange
also notes that the methodology for calculating the Indicative Clearing
Price is identical to the methodology used to calculate the clearing
price of the auction match, and thus the Indicative Clearing Price will
reflect the price at which the auction would occur as of the
dissemination time. Moreover, these data elements are substantially
similar to those currently provided by Nasdaq, as well as collar
information proposed by Nasdaq, Arca, and Bats.\135\ However, as
proposed, the Exchange will disseminate IEX Auction Information data
every one second between the Lock-in Time and the auction match for the
Opening and Closing Auctions, and during the Display Only Period for
IPO, Halt, and Volatility Auctions. In contrast, NYSE, Nasdaq and Bats
disseminate their auction data every five seconds. IEX believes that
disseminating auction data every second will contribute to increased
transparency regarding relevant auction information, thus leading to
more robust pricing, consistent with the protection of investors and
the public interest. Moreover, IEX Auction Information will be provided
to Members and other recipients of Exchange data on terms that are
reasonable and not unfairly discriminatory in that it will be provided
free of charge. IEX Auction Information will also be made available
free of charge on the Exchange's public Web site via the IEX Data
Platform.
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    \134\ As noted in the Purpose section, IEX intends to
disseminate substantially the same information through the
Consolidated Quotation System operated by the Consolidated Tape
Association (``CTA'') SIP, pending approval by the Operating
Committee of the CTA. Following such approval, IEX will amend Rule
11.330 to reflect this additional means of dissemination.
    \135\ See SR-NASDAQ-2016-131, SR-BatsBZX-2016-61, and NYSEArca-
2016-130.
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    The fields proposed for dissemination in IEX Auction Information
are strategically tailored to the IEX Auction model, and were developed
after informal discussion with various Members, as well as reference to
existing fields offered in auction data provided by other exchanges,
including the Nasdaq NOII, and the Bats Auction Feed. Specifically, the
Indicative Clearing Price and Auction Book Clearing Price are
substantially similar to the Nasdaq ``Near Clearing Price'' and ``Far
Clearing Price'' as well as the Bats ``Indicative Price'' and ``Auction
Only Price'', and should therefore be familiar to Members that trade in
the Nasdaq and Bats auctions.\136\ Similarly, the proposed Reference
Price field is substantially similar to the Reference Price utilized by
Bats.\137\
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    \136\ See the Bats US Equities Auction Process specification at
8, as well as the Nasdaq Net Order Imbalance Indicator User Guide at
4-5.
    \137\ See the Bats US Equities Auction Process specification at
7, and 5, which define the Reference Price as the price within the
Reference Price Range that maximizes the number of shares to be
executed, minimizes the imbalance, and minimizes the distance to the
Volume Based Tie Breaker.
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    Moreover, as proposed, the Exchange will utilize orders on the
Auction Book to calculate the Paired Shares, Imbalance Shares, and
Imbalance Side fields included in IEX Auction Information (i.e., both
displayed and non-displayed orders on the Continuous Book are not
accounted for when determining the number of shares that can be matched
or remain unexecuted at the current Reference Price). The proposed
Paired Shares, Imbalance Shares, and Imbalance Side fields are designed
to enhance the reliability of the fields disseminated in IEX Auction
Information, and mitigate potential gaming scenarios that could
negatively impact Users trading in IEX Auctions.
    Specifically, the fields as proposed are designed to avoid
disseminating Paired Shares and Imbalance Shares based on orders on the
Continuous Book that may be fleeting. Orders on the Continuous Book are
not subject to lock-in or lock-out restrictions, and may therefore be
canceled at any time before the auction match. Including potentially
fleeting orders in the Paired Shares and Imbalance Shares fields could
have negative implications for price discovery leading up to the
auction match by discouraging Users from offsetting Imbalance Shares,
leaving unmatched shares on the Auction Book at the time of the match
when Continuous Book orders that were ostensibly offsetting the
Imbalance Shares (and contributing to Paired Shares) are canceled prior
to the auction. Accordingly, the proposed fields are consistent with
the protection of investors and the public interest, in that they are
designed to increase the reliability of the fields disseminated in IEX
Auction Information, and mitigate potential gaming scenarios that could
negatively impact Users trading in IEX Auctions.
    Furthermore, as proposed, the Paired Shares field is designed to
allow Users to determine the likelihood of their Eligible Auction
Orders being executed in the auction. Specifically, because Paired
Shares only reflect orders that are locked in to the auction (and
therefore will be eligible for execution in the auction), Users can
assess their chances of receiving an execution in the auction match
based on the marketability of their order against the Indicative
Clearing Price, and the number of Paired Shares against their order
size. For example, if the final Indicative Clearing Price is $10.00,
and IEX has 100,000 shares paired, a User that has a LOC order to buy
10,000 shares with a limit price of $10.50 has a high likelihood of
receiving a 10,000 share execution in the Closing Auction. To continue
the example and highlight the positive effects of the proposed
functionality on price discovery, if the Indicative Clearing Price were
to have moved away from the participant (to $10.50, for example), such
User's chances of receiving an execution in the auction are diminished
because the auction match price has moved to the order's limit price,
and such order is ``locked-in'' (i.e., ineligible for modification or
cancelation). Accordingly, Users are incentivized to express their full
limit on Auction Eligible Orders in order to increase the likelihood of
receiving an execution in the Closing Auction at a price they believe
reflects the fundamental value of the security. This truthful
representation of full limit prices is designed to enhance price
discovery leading into the auction match, consistent with the
protection of investors and the public interest.
    The Exchange further notes that as proposed, the Paired Shares,
Imbalance Shares, and Imbalance Side fields are substantially similar
to the ``Reference Buy Shares'' and ``Reference Sell Shares'' fields
currently offered by Bats on the Bats Auction Feed, which provide the
number of shares associated with buy (sell) side Eligible Auction
Orders (which are on the Bats auction book, as defined in Bats Rule
11.23(a)(8)) that are priced equal to or greater (less) than the
Reference Price. However, rather than market participants deriving the
number of Paired Shares, Imbalance Shares, and the Imbalance Side, the
Exchange is proposing to derive and disseminate each value
independently.\138\ Moreover, Paired Shares, Imbalance Shares, and
Imbalance Side fields are substantially similar to the Paired Shares,
Imbalance Shares, and Imbalance Side fields that are currently offered
by Nasdaq in the NOII.\139\ Accordingly, IEX Auction Information,
including the proposed Paired Shares, Imbalance Shares, and

Imbalance Side fields do not present any new or novel issues not
already considered by the Commission and approved as consistent with
the protection of investors and the public interest.
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    \138\ Note, paired shares would be equal to the lesser of
Reference Buy Shares and Reference Sell Shares; Imbalance Shares
would be equal to the absolute value of Reference Sell Shares minus
Reference Buy Shares; and the side of the greater between Reference
Buy Shares and Reference Sell Shares is the imbalance side.
    \139\ See the Nasdaq Net Order Imbalance Indicator User Guide at
4-5.
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    The Exchange also believes that the proposed trading halt and LULD
trading pause rule provisions are consistent with the protection of
investors and the public interest because such provisions provide for
the imposition of a regulatory trading halt in an IEX-listed security
in order to prevent trading from occurring in such security when all
market participants do not have equal access to material news or other
information necessary to make an informed trading decision. With
respect to operational trading halts, proposed IEX Rule 11.280(g)(3)
provides appropriate optionality to Members and market makers in
determining whether to continue trading when there is an order
imbalance or influx on another market. As discussed in the Purpose
section, the proposed trading halt and LULD trading pause rules are
substantially similar to Nasdaq rules approved by the Commission
(described above) and thus do not raise any new or novel issues.
Moreover, the proposed LULD trading pause provisions are consistent
with the LULD Plan as well as Nasdaq rules.
    Lastly, the Exchange believes that the proposed operational rules
regarding IPO's conducted on the Exchange are consistent with the
protection of investors and the public interest because the process is
designed to provide underwriters with the necessary tools to ensure the
IPO Auction as well as continuous trading following the auction operate
in an orderly manner, consistent with the protections of investors and
the public interest. In addition, as noted above, the proposed
operational rules regarding IPO's are substantially similar to Nasdaq
Rule 4120(c)(8), and therefore do not present any novel issues the
Commission has not already considered.

B. Self-Regulatory Organization's Statement on Burden on Competition

    IEX does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. To the contrary, and as
discussed in the Statutory Basis section, the Exchange believes that
offering auctions is essential for operation of a listing market which
will allow the Exchange to provide companies with another listing
option, thereby promoting intermarket competition between exchanges in
furtherance of the principles of Section 11A(a)(1) \140\ of the Act in
that it is designed to promote fair competition among brokers and
dealers and among exchange markets by offering a new listing market to
compete with the existing Nasdaq and NYSE duopoly.
---------------------------------------------------------------------------

    \140\ 15 U.S.C. 78k-1(a)(1).
---------------------------------------------------------------------------

    With respect to the auction design, the Exchange does not believe
that the proposal will impose any burden on intermarket or intramarket
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. With respect to intermarket competition, as a new
listing venue, IEX expects to face intense competition from existing
exchanges. Consequently, the degree to which the IEX auction design
could impose any burden on intermarket competition is extremely
limited, and IEX does not believe that the auction design would impose
any burden on competing venues that is not necessary or appropriate in
furtherance of the purposes of the Act.
    With respect to intramarket competition, the auction design will
apply equally to all IEX Members and market participants that send
orders to IEX through IEX Members. Moreover, IEX believes that the
``open access'' auction design will result in auctions that attract
meaningful trading interest that will enable robust price discovery,
and enhance intramarket competition. All Members are permitted to enter
any type of Auction Eligible Order and there are no privileged
participants who receive enhanced priority, have access to special
order types, or receive information not available to other market
participants. Consequently, IEX does not believe that the proposal will
impose any burden on intramarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act.
    The Exchange also does not think that the content and manner by
which IEX Auction Information will be disseminated will impose any
burden on competition, since the data will be provided to all Members
and market participants free of charge and on terms that are not
unreasonably discriminatory.

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

    IEX requested comments from Members and other market participants
regarding the proposed auction design. The ``Request for Comment
Regarding Auctions for IEX-listed Securities'' was disseminated to IEX
Members and other market participants \141\ on November 14, 2016 (see
Exhibit 2). No written or verbal comments were received. However, as
discussed in the Purpose Section, in designing the proposed auctions,
the Exchange held discussions with a variety of buy-side and sell-side
market participants, including large banks and broker dealers that
provide a variety of services with diverse customer bases and trading
strategies, electronic market makers, asset managers, issuers and
institutional investors.
---------------------------------------------------------------------------

    \141\ Market participants that are not Members, but had
previously requested to be included in IEX communications were
included.
---------------------------------------------------------------------------

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission shall: (a) By order approve
or disapprove such proposed rule change, or (b) institute proceedings
to determine whether the proposed rule change should be disapproved.

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 email to<EMAIL_ADDRESS>Please include
File Number SR-IEX-2017-10 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-IEX-2017-10. This file
number should be included on the subject line if email 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, 100 F Street NE., Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 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 available publicly. All
submissions should refer to File Number SR-IEX-2017-10, and should be
submitted on or before May 30, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\142\
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    \142\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-09310 Filed 5-8-17; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 149 (Wednesday, August 3, 2016)]
[Notices]
[Pages 51267-51268]
[FR Doc No: 2016-18306]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2016-0072; Notice 1]

Cooper Tire & Rubber Company, Receipt of Petition for Decision of
Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Receipt of petition.

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SUMMARY: Cooper Tire & Rubber Company (Cooper), has determined that
certain Mastercraft and Big O tires do not fully comply with paragraph
S5.5(f) of Federal Motor Vehicle Safety Standard (FMVSS) No. 139, New
Pneumatic Radial Tires for Light Vehicles. Cooper filed a report dated
May 24, 2016, pursuant to 49 CFR part 573, Defect and Noncompliance
Responsibility and Reports. Cooper then petitioned NHTSA under 49 CFR
part 556 for a decision that the subject noncompliance is
inconsequential as it relates to motor vehicle safety.

DATES: The closing date for comments on the petition is September 2,
2016.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited in the title of this notice and be
submitted by any of the following methods:
     Mail: Send comments by mail addressed to U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
     Hand Deliver: Deliver comments by hand to U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. The
Docket Section is open on weekdays from 10 a.m. to 5 p.m. except
Federal Holidays.
     Electronically: Submit comments electronically by logging
onto the Federal Docket Management System (FDMS) Web site at http://www.regulations.gov/. Follow the online instructions for submitting
comments.
     Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that comments you have submitted by mail were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to http://www.regulations.gov, including any personal information
provided.
    The petition, supporting materials, and all comments received
before the close of business on the closing date indicated above will
be filed in the docket and will be considered. All comments and
supporting materials received after the closing date will also be filed
and will be considered to the extent possible.
    When the petition is granted or denied, notice of the decision will
also

be published in the Federal Register pursuant to the authority
indicated at the end of this notice.
    All documents submitted to the docket may be viewed by anyone at
the address and times given above. The documents may also be viewed on
the Internet at http://www.regulations.gov by following the online
instructions for accessing the dockets. The docket ID number for this
petition is shown in the heading of this notice.
    DOT's complete Privacy Act Statement is available for review in a
Federal Register notice published on April 11, 2000, (65 FR 19477-78).

SUPPLEMENTARY INFORMATION:
    I. Overview: Pursuant to 49 U.S.C. 30118(d) and 30120(h) and their
implementing regulations at 49 CFR part 556, Cooper submitted a
petition for an exemption from the notification and remedy requirements
of 49 U.S.C. Chapter 301 on the basis that this noncompliance is
inconsequential as it relates to motor vehicle safety.
    This notice of receipt of Cooper's petition is published under 49
U.S.C. 30118 and 30120 and does not represent any agency decision or
other exercise of judgment concerning the merits of the petition.
    II. Tires Involved: Affected are 22,188 of the following tubeless
radial tires manufactured between January 10, 2016, and April 30, 2016:
     Mastercraft LSR Grand Touring size 215/60R16.
     Mastercraft LSR Grand Touring size 225/60R16.
     Big O Legacy Tour Plus size 215/60R16.
     Big O Legacy Tour Plus size 225/60R16.
    III. Noncompliance: Cooper explains that due to a mold error, the
number of tread plies indicated on the sidewall of the subject tires
does not match the actual number of plies in the tire construction. The
tires are marked ``TREAD 1 PLY NYLON + 2 PLY STEEL + 2 PLY POLYESTER''
whereas the correct marking should be: ``TREAD 1 PLY NYLON + 2PLY STEEL
+ 1 PLY POLYESTER.'' As a consequence, these tires do not meet the
requirements specified in paragraph S5.5(f) of FMVSS No. 139.
    IV. Rule Text: Paragraph S5.5(f) of FMVSS No. 139 states, in
pertinent part:

    S5.5 Tire Markings. Except as specified in paragraph (a) through
(i) of S5.5, each tire must be marked on each sidewall with the
information specified in S5.5(a) through (d) and on one sidewall
with the information specified in S5.5(e) through (i) according to
the phase-in schedule specified in S7 of this standard . . .
    (f) The actual number of plies in the sidewall, and the actual
number of plies in the tread area, if different.

    V. Summary of Cooper's Petition: Cooper described the subject
noncompliance and stated its belief that the noncompliance is
inconsequential as it relates motor vehicle safety and is unlikely to
have an adverse impact on motor vehicle safety.
    In support of its petition, Cooper submitted the following
information pertaining to the subject noncompliance:
    (a) Cooper states that the mislabeled number of plies indicated on
the sidewalls has no impact on the operational performance or
durability of the subject tires or on the safety of vehicles on which
those tires are mounted. Cooper states that while the subject tires do
not indicate the correct number of plies in the tread on the outboard
side, they meet all other performance requirements under the Federal
Motor Vehicle Safety Standards. Cooper notes that the number of plies
in the tread does not impact the performance or operation of a tire and
does not create a safety concern to either the operator of the vehicle
on which the tires are mounted, or the safety of personnel in the tire
repair, retread and recycle industry.
    (b) Cooper also states that the subject tires were built as
designed and meet or exceed all performance requirements and testing
requirements specified under FMVSS No. 139. Cooper states that the
subject tires completed all Cooper Tire internal compliance testing
criteria, including passing shipping certification testing in January
2016. In addition, the 215/60R16, Mastercraft LRS Grand Touring, serial
week 1116, passed all surveillance testing conducted in early March
2016.
    (c) Cooper's states that the stamping deviation occurred as a
result of an administrative error when incorrect information was
entered into Cooper Tire's electronic specification system at the
corporate level. That system communicates information to the mold
management system which in turn generates the construction stamping
pocket plate. The electronic specification system incorrectly listed
the specific tire sizes and brands as two-ply, when the tires were
actually designed with an HPL construction or as having a single ply in
the tread. The incorrect construction information was then engraved in
the pocket plate and then installed in the affected molds.
    (d) Cooper states that it is not aware of any crashes, injuries,
customer complaints, or field reports associated with the mislabeling.
    Cooper states that the mislabeling has been corrected at the
corporate level and the pocket plates of the molds have been replaced,
therefore, no additional tires will be manufactured or sold with the
noncompliance. Cooper also states that it has conducted training with
tire engineers at the corporate level responsible for inputting
information into the electronic specification system on the importance
of the information they are submitting.
    Cooper observed that NHTSA has previously granted inconsequential
noncompliance petitions regarding noncompliances that are similar to
the subject noncompliance.
    Cooper concluded by expressing the belief that the subject
noncompliance is inconsequential as it relates to motor vehicle safety,
and that its petition to be exempted from providing notification of the
noncompliance, as required by 49 U.S.C. 30118, and a remedy for the
noncompliance, as required by 49 U.S.C. 30120, should be granted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, any decision on
this petition only applies to the subject tires that Cooper no longer
controlled at the time it determined that the noncompliance existed.
However, any decision on this petition does not relieve equipment
distributors and dealers of the prohibitions on the sale, offer for
sale, or introduction or delivery for introduction into interstate
commerce of the noncompliant tires under their control after Cooper
notified them that the subject noncompliance existed.

    Authority: 49 U.S.C. 30118, 30120: delegations of authority at
49 CFR 1.95 and 501.8.

Jeffrey M. Giuseppe,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2016-18306 Filed 8-2-16; 8:45 am]
 BILLING CODE 4910-59-P