Page 1 of 25 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES April 6, 2006 Memorandum SUBJECT: TCMTB [ 2( Thiocyanomethylthio) benzothiazole]: First Revision of the Occupational and Residential Exposure Assessment for the Reregistration Eligibility Decision Document.

PC Code: 035603 ( TCMTB)

DP Barcode: D324014 FROM: Charles Smith Reregistration Branch 2 Health Effects Division ( 7509C)

THROUGH: Alan Nielsen, Senior Scientist Reregistration Branch 2 Health Effects Division ( 7509C)

TO: Kathryn Avivah Jakob, Chemical Review Manager Regulatory Management Branch 2 Antimicrobials Division ( 7510C)

and Deborah Smegal, Risk Assessor Reregistration Branch 1 Health Effects Division ( 7509C)

The attached assessment is the occupational and non occupational ( residential) exposure and risk estimates for TCMTB to support the Antimicrobial Division's reregistration eligibility Page 2 of 25 decision ( RED) document. The assessment was reviewed by HED's Science Council for Exposure ( ExpoSAC) to ensure compliance with current HED policy as well as ExpoSAC standard operating procedures ( SOPs) for conducting occupational and residential exposure ( ORE) assessments. Page 3 of 25 Table of Contents Executive Summary.................................................................................................................... 4 1.0 Occupational and Residential Exposure/ Risk Assessment................................................ 6 1.1 Purpose ....................................................................................................................... 6 1.2 Criteria for Conducting Exposure Assessments............................................................ 6 1.3 Summary of Hazard Concerns for TCMTB.................................................................. 6 1.4 Incident Reports .......................................................................................................... 9 1.5 Summary of Physical and Chemical Properties of TCMTB.......................................... 9 1.6.1 End Use Products .............................................................................................. 10 1.6.2 Registered Use Categories and Sites .................................................................. 10 1.6.3 Application Methods.......................................................................................... 10 2.0 Occupational Exposures and Risks ................................................................................ 11 2.1 Occupational Handler Exposures and Risks ............................................................... 11 2.1.1 Data and Assumptions for Handler Exposure Scenarios ..................................... 13 <IP_ADDRESS> Assumptions for Handler Exposure Scenarios ................................................ 13 <IP_ADDRESS> Exposure Data for Handler Exposure Scenarios ............................................. 14 2.1.2 Noncancer TCMTB Handler Exposure and Assessment ..................................... 17 <IP_ADDRESS> Noncancer TCMTB Handler Exposure and Risk Calculations........................ 17 <IP_ADDRESS> TCMTB Noncancer Risk Summary................................................................ 18 2.1.3 Cancer TCMTB Handler Exposure and Risk Assessment................................... 24 2.1.4 Summary of Risk Concerns/ Data Gaps for Occupational Handlers..................... 24 <IP_ADDRESS> Summary of Risk Concerns............................................................................ 24 <IP_ADDRESS> Summary of Data Gaps .................................................................................. 24 2.1.5 Recommendations For Refining Handler Risk Assessment ............................... 24 Page 4 of 25 Executive Summary TCMTB is a broad spectrum biocide used in commercial and on farm seed treatment settings. It is formulated as a liquid concentrate.

Hazard Concerns: The toxicological endpoints used to complete the occupational and residential risk assessment were based on the best professional judgment of AD toxicologists. Adverse effects were identified at durations of exposure ranging from short term ( up to 30 days) to intermediate term durations (> 30 days up to 6 months) and long term durations (> 6 months). No cancer endpoint was identified, therefore, cancer risks are not assessed.

The short and intermediate term ( noncancer) dermal risk assessment for TCMTB is based on an NOAEL of 25 mg/ kg/ day from a dermal study. The NOAEL was based on decreased body weight gain and food consumption in males, in addition to significant hematalogical ( increased neutrophils, decreased hemoglobin, hematocrit and erythrocytes) and clinical chemistry changes ( increased urea nitrogen, glucose and globulins). Long term exposures to TCMTB ( i. e., greater than 6 months) are not expected for current registered uses. HED's level of concern ( LOC) for occupational TCMTB dermal exposures is 100. The shortand intermediate term ( noncancer) inhalation risk assessment for TCMTB is based on an NOAEL of 16 mg/ kg/ day, which is based on an oral rabbit development study. The NOAEL was based on reduced body weight gain and food consumption. Long term exposure to TCMTB ( i. e., greater than 6 months) is not expected for current registered uses. HED's level of concern ( LOC) for short and intermediate term occupational ( and residential) TCMTB inhalation exposures is 100. The dermal and inhalation margins of exposure were combined for the TCMTB risk assessment because the toxicity endpoints for the dermal and inhalation routes of exposure are based on the same toxicological effects.

The Health Effects Division Carcinogenicity Peer Review Committee ( CPRC) met on June 28, 1995 to discuss and evaluate the weight of the evidence on 2( Thiocyanomethylthio) benzothiazole ( TCMTB) with particular reference to its carcinogenic potential. The CPRC concluded that TCMTB should be classified as Group C  possible human carcinogen  and recommended that for the purpose of risk characterization, the Reference Dose ( RfD) approach should be used for quantitation of human risk. This was based on statistically significant increases in tumors in both sexes of the Sprague Dawley rat: testicular interstitial cell adenomas in males and thyroid c cell adenomas in females.

Use Patterns: TCMTB is a fungicide used for treating seeds in the United States. It is used in commercial and on farm settings.

Occupational Handler Risks: For commercial seed treatment, all dermal MOEs met or exceeded the required uncertainty factor of 100 at some level of mitigation. However, a few of the inhalation MOEs did not meet or exceed the required uncertainty factor of 100. Risks remain a concern for 3 scenarios even with maximum inhalation risk mitigation: Page 5 of 25 $ Multiple activities for barley, cotton, oat, rice, safflower, and wheat seeds.

For all of the on nursery seed treatment scenarios, dermal and inhalation MOEs met or exceeded the required uncertainty factor of 100 at some level of risk mitigation.

For commercial seed treatment, all combined dermal and inhalation risks, except for a few scenarios, did not meet or exceed the required uncertainty factor of 100 even with maximum risk mitigation. Risks remain a concern for 4 scenarios even with maximum risk mitigation:

  Loader/ Applicator activities for safflower seeds.   Multiple activities for barley, cotton, oat, rice, safflower, and wheat seeds. Page 6 of 25 1.0 Occupational and Residential Exposure/ Risk Assessment 1.1 Purpose This document is the occupational and residential non dietary exposure and risk assessment for TCMTB from its use as a fungicide. In this document, which is for use in EPA's development of the Antimicrobials Division ( AD) chapter of the TCMTB RED Document, EPA presents the results of its review of the potential human health effects of occupational and residential/ non occupational exposure to TCMTB.

1.2 Criteria for Conducting Exposure Assessments An occupational and/ or residential exposure assessment is required for an active ingredient if ( 1) certain toxicological criteria are triggered and ( 2) there is a potential for exposure to handlers ( mixers, loaders, applicators) during use or to persons entering treated sites or exposed to vapors after application is complete. Toxicological endpoints were selected for short and intermediate term dermal and inhalation exposures to TCMTB. There is a significant potential for exposure in a variety of occupational agricultural and commercial seed treatment settings. There are no residential uses currently registered for TCMTB. Therefore, risk assessments are required for occupational handlers that can occur as a result of TCMTB use.

1.3 Summary of Hazard Concerns for TCMTB 2( Thiocyanomethylthio) benzothiazole ( TCMTB)  Report of the Antimicrobials Division Toxicity Endpoint Selection Committee ( ADTC). M. McMahon and M. Centra dated January 12, 2006.

The toxicological endpoints used to complete the occupational and residential risk assessment were based on the best professional judgment of AD toxicologists. Adverse effects were identified at durations of exposure ranging from short term ( up to 30 days) to intermediateterm durations (> 30 days up to 6 months) and long term durations (> 6 months). No cancer endpoint was identified, therefore, cancer risks are not assessed.

TCMTB is a fungicide where the use patterns can vary widely ranging from short term through intermediate term exposure durations. As such, when the Antimicrobials Division Toxicity Endpoint Selection Committee ( ADTC) evaluated the TCMTB hazard database, endpoints were selected to address the various durations of exposure. TCMTB exposures are expected to occur only to occupational users. Page 7 of 25 Dermal Route ( noncancer)

The short and intermediate term ( noncancer) dermal risk assessment for TCMTB is based on an NOAEL of 25 mg/ kg/ day from a dermal study. The NOAEL was based on decreased body weight gain and food consumption in males, in addition to significant hematalogical ( increased neutrophils, decreased hemoglobin, hematocrit and erythrocytes) and clinical chemistry changes ( increased urea nitrogen, glucose and globulins). Long term exposures to TCMTB ( i. e., greater than 6 months) are not expected for current registered uses.

Inhalation Route ( noncancer)

The short and intermediate term ( noncancer) inhalation risk assessment for TCMTB is based on an NOAEL of 16 mg/ kg/ day, which is based on an oral rabbit development study. The LOAEL was based on reduced body weight gain and food consumption. Long term exposure to TCMTB ( i. e., greater than 6 months) is not expected for current registered uses.

Incidental Oral Route ( noncancer)

The short and intermediate term ( noncancer) incidental oral risk assessment for TCMTB is based on an NOAEL of 16 mg/ kg/ day, which is based on an oral rabbit development study. The LOAEL was based on reduced body weight gain and food consumption.

Noncancer Level of Concern ( LOC)

HED's level of concern ( LOC) for occupational TCMTB dermal and inhalation exposures is 100 ( i. e., a margin of exposure ( MOE) less than 100 exceeds HED's level of concern). The level of concern is based on a 10x for interspecies extrapolation and a 10x for intraspecies extrapolation.

Aggregation The dermal and inhalation margins of exposure were combined for the TCMTB risk assessment because the toxicity endpoints for the dermal and inhalation routes of exposure are based on the same toxicological effects.

Cancer The Health Effects Division Carcinogenicity Peer Review Committee ( CPRC) met on June 28, 1995 to discuss and evaluate the weight of the evidence on 2( Thiocyanomethylthio) benzothiazole ( TCMTB) with particular reference to its carcinogenic potential. The CPRC concluded that TCMTB should be classified as Group C  possible human carcinogen  and recommended that for the purpose of risk characterization, the Reference Dose ( RfD) approach should be used for quantitation of human risk. This was based on statistically significant increases in tumors in both sexes of the Sprague Dawley rat: testicular interstitial cell adenomas in males and thyroid C cell adenomas in females. Page 8 of 25 Acute Toxicity TCMTB is classified as category II for acute oral toxicity, category III for acute dermal toxicity, and category I for inhalation toxicity. It is classified as category I for primary eye irritation potential and category II for primary skin irritation potential. Results were positive for dermal sensitization. The acute toxicity profile for TCMTB is presented in Table 1.

Body Weight The adverse effects for the dermal and inhalation endpoint are observed in the general population. Therefore, the body weight of an average adult ( i. e., 70 kg) was used to estimate dermal dose.

Table 1. Acute Toxicity Profile  TCMTB Guideline No. Study Type MRID( s) Results Toxicity Category 81 1 Acute Oral 41583801 LD50 = 750 mg/ kg II 81 2 Acute Dermal 41515401 LD50 > 2000 mg/ kg III 81 3 Acute Inhalation 41640601 LC50 = 0.07 mg/ L I 81 4 Primary Eye Irritation Acc no. 111991 I 81 5 Primary Skin Irritation 41583701 Severe erythema at 72 hrs. II 81 6 Dermal Sensitization 42349201 Sensitizer Table 2. Summary of Toxicological Doses and Endpoints for TCMTB Exposure Scenario Dose Used in Risk Assessment, UF Special FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietary ( general population) NOAEL = 25.1 mg/ kg/ day UF = 100 Acute RfD = 0.25 mg/ kg/ day FQPA SF = 1X aPAD = acute RfD FQPA SF aPAD = 0.25 mg/ kg/ day Rat Developmental Study LOAEL = 76.5 mg/ kg/ day based on clinical signs of ventral toxicity ( alopecia, rough coat, dyspnea/ wheezing, oral discharge, diarrhea/ loose stool, urine staining, piloerection and hunched gait).

Chronic Dietary ( all populations) LOAEL = 3.8 mg/ kg/ day UF = 300 Chronic RfD = 0.013 mg/ kg/ day FQPA SF = 1X PAD = chronic RfD FQPA SF cPAD = 0.013 mg/ kg/ day One year Dog Study LOAEL = 3.8 mg/ kg/ day based on decreased body weight gain, white cells, monocytes and plasma ALT in males and decreased plasma ALT and uterine weight in females. Page 9 of 25 Table 2. Summary of Toxicological Doses and Endpoints for TCMTB Exposure Scenario Dose Used in Risk Assessment, UF Special FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Incidental Oral Shortand Intermediate Term ( 1  30 days) NOAEL = 16 mg/ kg/ day UF = 100 MOE = 100 Rabbit Developmental Study LOAEL = 32 mg/ kg/ day based on reduced body weight gain and food consumption.

Dermal Short, Intermediate, and Long Term ( 1  30 days) Dermal NOAEL = 25 mg/ kg/ day MOE = 100 21 Day Dermal toxicity study in Rats LOAEL = 100 mg/ kg/ day for systemic toxicity based on decreased body weight gain and food consumption in males, in addition to significant hematalogical ( increased neutrophils, decreased hemoglobin, hematocrit and erythrocytes) and clinical chemistry changes ( increased urea nitrogen, glucose and globulins).

Inhalation Short and Intermediate Term ( 1  30 days) NOAEL = 16 mg/ kg/ day ( Inhalation absorption rate = 100%) MOE = 100 Rabbit Developmental Study LOAEL = 32 mg/ kg/ day based on reduced body weight gain and food consumption.

Inhalation Long Term (> 6 months) LOAEL = 3.8 mg/ kg/ day ( Inhalation absorption rate = 100%) MOE = 1000 One year Dog Study LOAEL = 3.8 mg/ kg/ day based on decreased body weight gain, white cells, monocytes and plasma ALT in males and decreased plasma ALT and uterine weight in females.

1.4 Incident Reports An analysis of incidence reports will be included in a separate memo.

1.5 Summary of Physical and Chemical Properties of TCMTB TCMTB ( CAS registry number 21564 17 0) is a dark orange liquid with a molecular formula of C9H6N2S3 and a molecular weight of 238.3 g/ mole. It is has a faint, mild odor. TCMTB is miscible with most organic solvents and can be formulated with a range of surface active agents which can form stable emulsions when diluted further with water. Page 10 of 25 1.6 Summary of Use Patterns and Formulations 1.6.1 End Use Products TCMTB is a fungicide used for treating seeds in the United States. It is used in agricultural and commercial settings. TCMTB is formulated as a liquid.

1.6.2 Registered Use Categories and Sites An analysis of the current labeling and available use information was completed by HED. TCMTB is registered for use in agricultural and commercial seed treating ( see Table 3).

Table 3: Summary of Maximum Application Rates for Registered TCMTB Commercial and Agricultural Uses Crop Target Formulationa Maximum Application Rate Application Equipment ( Area Treated or Amount Handled Daily)

Barley Seed, Oat Seed, Rice Seed, Wheat Seed Seed L 0.026 lbs ai/ 100 lbs of seed commercial treater 0.13 lbs ai/ 100 lbs of seed commercial treater Cotton Seed Seed L 0.051 lbs ai/ 100 lbs of seed on farm treater Safflower Seed, Sugar beet Seed Seed L 0.041 lbs ai/ 100 lbs of seed commercial treater a L = Liquid concentrate 1.6.3 Application Methods TCMTB is applied to seeds during both on farm and commercial seed treatment. The following descriptions of seed treatment and planting methods and equipment are based primarily on information provided in HED's seed treatment SOP ( SOP 14), which was developed in consultation with industry specialists.

Commercial Seed Treatment: Commercial seed treaters are designed to apply accurately measured quantities of pesticides to a given weight of seed. There are two primary methods for treating seeds: the batch system and the continuous flow system. The batch system is less automated and generates lower production volume than the continuous flow system. Seed treatment in commercial facilities occurs primarily via the highly automated continuous flow system. Treated seed is bagged by a machine which picks up a bag, opens it, and lets it fill to a predetermined weight. The bagger then folds the top of the bag, and attaches the seed grade certificates and treatment tags. The sewer then sews the bag shut using an automated sewing machine. The bag is then moved by a conveyer belt to a pallet area where it is stacked for Page 11 of 25 shipping. Seed treatment workers may rotate duties to other areas. In the smaller, less automated facilities in particular, one worker will often have multiple duties within the plant.

On Nursery Seed Treatment & Planting of Treated Seed: There are various pieces of equipment used for on nursery seed treatment, such as drum mixers, homemade devices using augers, cement mixers, hand cranked revolving drums, and gravity feed systems. The more sophisticated on nursery treaters are essentially miniature versions of the commercial treaters. Simpler units consist of reusable chemical containers, a power source ( vehicle battery), valve and pump or compressed air, and tubing spray nozzles. These units are mounted directly on a truck box or wagon to dispense seed treatment directly into an auger conveyance system. Seed may be treated as it is augered from the grower's truck to the storage bin or seeder or from the storage bin to the farmer's truck or seeder. This type of enclosed on nursery treatment system is available only for liquid formulations.

The treated seed can be planted with a wide range of equipment. Common equipment types include: specialized drills with a box for small seeds and disk openers with depth bands to place the seeds at the appropriate depth followed by packer wheels to firm soil over and around seeds; double corrugated roller seeders, which drop the seed between the rollers followed by a second roller, which covers the seed and firms the soil; and booms, delivery tubes, and air pressure that blow seed onto the soil at properly spaced intervals followed by light packing, dragging a chain or harrowing to cover the planted seed. Seeding rate is determined by factors such as machine wear, seed size and shape, and crop variety.

2.0 Occupational Exposures and Risks There is a potential for exposure to TCMTB in occupational scenarios from handling TCMTB products during the seed treating process ( both commercial and on farm) and a potential for postapplication worker exposure from handling seed previously treated with TCMTB. As a result, risk assessments have been completed for occupational handler scenarios as well as occupational postapplication scenarios.

2.1 Occupational Handler Exposures and Risks HED uses the term " handlers" to describe those individuals who are involved in the pesticide application process. HED believes that there are distinct job functions or tasks related to applications and that exposures can vary depending on the specifics of each task. Job requirements ( e. g., amount of chemical to be used in an application), the kinds of equipment used, the target being treated, and the level of protection used by a handler can cause exposure levels to differ in a manner specific to each application event.

HED uses exposure scenarios to describe the various types of handler exposures that may occur for a specific active ingredient. The use of scenarios as a basis for exposure assessment is Page 12 of 25 very common as described in the U. S. EPA Guidelines for Exposure Assessment ( U. S. EPA; Federal Register Volume 57, Number 104; May 29, 1992). Information from the current labels, use and usage information, toxicology data, and exposure data were all key components in the development of the exposure scenarios. HED has developed a series of general descriptions for tasks that are associated with pesticide applications. Tasks associated with occupational pesticide handlers are categorized using one of the following terms:

On Farm Loader/ Applicator: The possible points of operator exposure for an on nursery treatment are; transport of pesticide in mobile containers, moving pesticide from storage in to seed treatment equipment, introduction of pesticide into seed treatment equipment, and equipment cleaning and maintenance. On nursery seed treatment with liquid formulations is generally done with more automated equipment, essentially miniature versions of commercial treaters. Seed may be treated as it is augured from the grower's truck to the storage bin ( at the farmstead), or from the truck to the seeder ( field) or from the grower's storage bin into either a truck or seeder.

$ On Farm Planting of Treated Seed: Planting exposures occur during both the loading of hoppers and driving the equipment.

$ Commercial Mixer/ Loader/ Applicator for Seed Treatments: This scenario involves loading/ applying of all formulations in a commercial operation.

$ Commercial Bagger for Seed Treatments: Seed is bagged by a machine which picks up a bag, opens it, slips it over a spout and lets it fill to a predetermined weight. The bagger then folds the top of the bag, attaches the seed grade certificates and treatment tags.

$ Commercial Sewer for Seed Treatments: After bagging the treated seed the sewer shuts the bag using an automatic sewing machine. The bag is then moved by a conveyer belt to a pallet area where it is stacked for shipping.

$ Multiple Commercial Activities for Seed Treatments: The SOP contains a scenario labeled " Multiple Activities" to address the potential for multiple types of exposure in small commercial operations.

A chemical can produce different effects based on how long a person is exposed, how frequently exposures occur, and the level of exposure. HED classifies exposures up to 30 days as short term and exposures greater than 30 days up to several months as intermediate term. HED completes both short and intermediate term assessments for occupational scenarios in essentially all cases, because these kinds of exposures are likely and acceptable use/ usage data are not available to justify deleting intermediate term scenarios. Based on use data and label instructions, HED believes that occupational TCMTB exposures may occur over a single day or up to weeks at a time for many use patterns and that intermittent exposure over several weeks also may occur. Some applicators may apply TCMTB over a period of weeks, because they are commercial seed treaters. Long term handler exposures are not expected to occur for TCMTB. Page 13 of 25 Other parameters are also defined from use and usage data such as application rates and application frequency. HED always completes noncancer risk assessments using maximum application rates for each in order to ensure there are no concerns for each specific use.

Occupational handler exposure assessments are completed by HED using different levels of risk mitigation. Typically, HED uses a tiered approach. The lowest tier is designated as the baseline exposure scenario ( i. e., long sleeve shirt, long pants, shoes, socks, and no respirator). If risks are of concern at baseline attire, then increasing levels of personal protective equipment or PPE ( e. g., gloves, double layer body protection, and respirators) are evaluated. If risks remain a concern with maximum PPE, then engineering controls ( e. g., closed mixing/ loading systems) are evaluated. This approach is used to ensure that the lowest level of risk mitigation that provides adequate protection is selected, since the addition of PPE and engineering controls involves an additional expense to the user and   in the case of PPE   also involves an additional burden to the user due to decreased comfort and dexterity and increased heat stress and respiratory stress.

2.1.1 Data and Assumptions for Handler Exposure Scenarios <IP_ADDRESS> Assumptions for Handler Exposure Scenarios A series of assumptions and exposure factors served as the basis for completing the occupational handler risk assessments. Each assumption and factor is detailed below on an individual basis. The assumptions and factors used in the risk calculations include:

$ Occupational handler exposure estimates were based on surrogate data from: the Health Effects Division Science Advisory Committee on Exposure ( HED ExpoSAC) SOP # 15: Amount of Seed Treated or Planted per Day, which was completed on March 2, 2004.

$ The toxicological endpoint of concern for dermal risks is from a dermal study; with the effects seen in males and females, therefore, the average body weight of an adult handler ( i. e., 70 kg) is used to complete the dermal noncancer risk assessment. The toxicological endpoint of concern for inhalation risks is from an oral study; with the effects seen in males and females, therefore, the average body weight of an adult handler ( i. e., 70 kg) is used to complete the inhalation noncancer risk assessment.

$ Generic protection factors ( PFs) were used to calculate exposures when data were not available. For example, an 80 percent protection factor was assumed for the use of a respirator equipped with a quarter face dust/ mist filter.

$ On farm treaters and planters are expected to have short term exposure duration ( less than 30 days) for all seed crops. Page 14 of 25 $ Personal protective equipment for on nursery and commercial mixer/ loader/ applicators and planter includes a single layer and gloves. Personal protective equipment for commercial baggers and sewers includes baseline attire only  no gloves. Personal protective equipment for performing multiple activities in a commercial operation includes a single layer of clothing and gloves $ Exposure factors used to calculate daily exposures to handlers are based on applicable data, if available. For lack of appropriate data, values from a scenario deemed similar enough by the assessor might be used.

$ For noncancer assessments, HED assumes the maximum application rates allowed by labels in its risk assessments ( see Table 3).

$ The average occupational workday is assumed to be 8 hours.

$ The daily pounds of seed treated per day were defined for each handler scenario by determining the amount that can be reasonably treated in a single day. These assumptions are taken from the HED's ExpoSAC SOP # 15. The standard values in this SOP are based on the information obtained from the registrants, seed treatment equipment manufacturers, and Agency experts. The values listed are considered to be typical tohigh end values. The default values may be modified by pesticide specific knowledge that affects the amount of seed that can be treated or planted in a day ( e. g., high amount of seed required per acre) but in the case of TCMTB, no such data is available. The values are as follows:  for commercial seed treatment facilities it is assumed that for barley, rice, safflower, and wheat seed   718,000 lb seed is treated per day; for cotton seed   160,000 lb seed is treated per day; and for sugar beet seed   88,000 lb seed is treated per day.  for on farm treatments it is assumed that 200 acres is planted per day for cotton ( 18 lbs of seed per acre), oats ( 128 lbs of seed per acre), rice ( 150 lbs of seed per acre), and wheat ( 150 lbs of seed per acre) seeds; 80 acres is planted per day for safflower ( 100 lbs of seed per acre) and sugar beet ( 8 lbs of seed per acre) seeds; and 35 acres is planted per day for barley ( 100 lbs of seed per acre) seeds.

There are data gaps that have been identified for some TCMTB applications. Each is identified in the calculation tables and is also noted in the summary of risk calculations.

<IP_ADDRESS> Exposure Data for Handler Exposure Scenarios HED uses unit exposure to assess handler exposures to pesticides. Unit exposures are estimates of the amount of exposure to an active ingredient a handler receives while performing various handler tasks and are expressed in terms of micrograms or milligrams of active ingredient per pounds of active ingredient handled. HED has developed a series of unit exposures that are unique for each scenario typically considered in our assessments ( i. e., there are different unit exposures for different types of application equipment, job functions, and levels Page 15 of 25 of protection). The unit exposure concept has been established in the scientific literature and also through various exposure monitoring guidelines published by the U. S. EPA and international organizations such as Health Canada and OECD ( Organization for Economic Cooperation and Development).

Exposure data used for the TCMTB seed treatment assessment are taken primarily from HED's recently developed seed treatment standard operating procedure ( SOPs for Seed Treatment, 6/ 1/ 03) and also are based on professional judgment. The seed treatment SOP contains representative scenarios for worker exposure associated with seed treatment facilities and planting treated seed. The data contained in the SOP are mostly generated by industry sources. Exposure estimates are from actual seed treatment studies and are based on exposure factors associated with occupational handler scenarios ( i. e., commercial seed treatment, onnursery seed treatment, planting of treated seed). Eight seed treatment studies were used in developing the SOP. Given the high level of variance in the data, multiple statistical analyses were undertaken to help ensure derivation of a statistically sound exposure value for the different scenarios evaluated. For all selected seed treatment studies, replicates were combined into sets of equivalent job functions. This process resulted in four categories of commercial seed treatment activities ( loader/ applicator, sewer, bagger, and multiple activities), and two categories for on nursery activities ( treater and planter).

On Nursery Seed Treatment and Planting On Nursery Loader/ Applicator: No studies were available to address exposure to liquid formulations in an on nursery facility. On nursery seed treatment with liquid formulations is generally done with more automated equipment, essentially miniature versions of commercial treaters.

On Nursery Planting of Treated Seed: Exposure estimates for loading and planting of treated seed are based on 2 exposure studies ( MRID # 42251901, 45654503). In one study, workers loaded and drilled seed treated with Baytan at 13 different sites in the UK. The seed was loaded into the drill hoppers from 0.5 or 1 ton super sacks or 50 kg bags. The amount of seed handled ranged from 1100 to 12,100 lbs and the amount of ai handled ranged from 0.35 to 4.72 lbs. The loading time ranged from 19 to 83 minutes, while the planting time ranged from 155 to 487 minutes. The seed planting rate per acre was not given. The same worker performed both the loading and planting. Dermal exposure was measured with inner and outer whole body dosimeters which included a cap, a jacket and trousers over a long sleeve T shirt and long johns and two sets of cotton gloves. The gloves were changed at the end of loading. Inhalation exposures were measured with 37 mm glass fiber filters and the filters were changed after loading. The dermal results were adjusted by a clothing protection factor to account for the fact that 5% of the outer residues were found on the inner dosimeters.

In the second study workers loaded and drilled canola seed treated with Oftanol, which forms a hard shell coating. The 13 replicates for this study were located at one site in Manitoba using four different planting rigs. Four workers participated in the study and the replicates averaged 3.2 hours in duration. The seed was loaded into the drill hoppers from 25 kg bags. Page 16 of 25 The amount of seed handled per replicate averaged 360 pounds and the amount of ai handled averaged 4.33 lbs. The seed was planted at a rate of 6 to 8 pounds per acre. The same worker performed both the loading and planting. Dermal exposure was measured with patches located both inside and outside the worker's coverall. Hand exposures were measured by hand rinse. Inhalation exposures were measured with 37 mm quartz microfiber filters.

Commercial Seed Treatment Commercial Loader/ Applicator: Exposure estimates are based on a subset of 3 exposure studies ( MRID Nos. 43080049, 42251902, 44904526). The loader/ applicator activities in these 3 exposure studies encompass a wide range of seed treaters, amounts of seed and amounts of pesticides handled for seed treatment scenarios. The three studies monitored an open loading/ applying activity for various seed treatment facilities. There is an average of 9 replicates per study ( ranging from 1 to 20 replicates per study). Two of the three studies monitored dermal exposures with patch dosimetry, hand rinses, and face wipes. The methodology in the third study was whole body dosimetry, hand rinses and face wipes.

Commercial Bagger: Exposure estimates for bagging activities for all formulations are based on data from 3 exposure studies ( MRID Nos. 43080049, 42251902, and 44904526). The studies monitored bagging treated seed in various seed treatment facilities and encompassed a wide range of bagging equipment, and amount of seed and pesticides handled. The number of replicates ranged from 1 to 20 per study. Two of the studies monitored dermal exposures with whole body dosimeters, and face, neck and hand rinses. The third used dermal patches and hand rinses to monitor exposure.

Commercial Sewer: Exposure estimates for sewing activities for all formulations are based on data from 2 exposure studies ( MRID # 430800 49, and449045 26). The two studies monitored sewing various bags of treated seed in a number of seed treatment facilities. The number of replicates ranges from 1 to 20 per study. Both of the studies monitored dermal exposures with whole body dosimeters, and face, neck and hand rinses.

Multiple Commercial Activities: Exposure estimates for multiple activities for all formulation are based on data from 4 exposure studies ( MRID # s, 454427 01, 422519 02, 449045 26 and 447315 01). These studies encompass a variety of seed treatment activity and a wide range of amount of seed pesticides handled. The four studies in this scenario monitored multiple activities for various seed treatment facilities. The number of replicates ranges from 3 to 45 per study. Three of the five studies monitored dermal exposures with whole body dosimeter, face and neck and hand rinses. The methodology in the other studies was dermal patches and hand rinses.

TCMTB Handler Exposure Scenarios It has been determined that exposure to pesticide handlers is likely during the occupational use of TCMTB in a variety of occupational environments. The anticipated use patterns and current labeling indicate several occupational exposure scenarios based on the types Page 17 of 25 of equipment and techniques that can potentially be used for TCMTB applications. The quantitative exposure/ risk assessment developed for occupational handlers is based on the following scenarios.

Seed treatment:

( S 1) loading and applying liquid formulations with commercial seed treatment equipment, ( S 2) commercial sewer stitching bags of seed, ( S 3) bagging and otherwise handling treated seeds with commercial equipment, ( S 4) multiple commercial seed treatment activities, ( S 5) on nursery loading/ applying seed treatment, and ( S 6) on nursery loading/ planting previously treated seeds.

2.1.2 Noncancer TCMTB Handler Exposure and Assessment <IP_ADDRESS> Noncancer TCMTB Handler Exposure and Risk Calculations Daily Exposure: Daily dermal or inhalation handler exposures are estimated for each applicable handler task with the application rate, the area treated in a day, and the applicable dermal or inhalation unit exposure using the following formula:

Daily Exposure ( mg ai/ day) = Unit Exposure ( mg ai/ lb ai handled) * Application Rate ( lbs ai/ area) * Daily Area Treated ( area/ day)

Where:

Daily Exposure = Amount ( mg ai/ day) deposited on the surface of the skin that is available for dermal absorption or amount inhaled that is available for inhalation absorption; Unit Exposure = Unit exposure value ( mg ai/ lb ai handled) derived from August 1998 PHED data, from ORETF data; Application Rate = Normalized application rate based on a logical unit treatment, such as acres, square feet, or gallons. Maximum values are generally used ( lb ai/ cut weight); and Daily Area Treated = Normalized application area based on a logical unit treatment such as acres ( A/ day).

Daily Dose: The daily dermal or inhalation dose is calculated by normalizing the daily exposure by body weight and adjusting, if necessary, with an appropriate dermal or inhalation absorption factor. For all exposure scenarios for TCMTB, an average adult body weight of 70 kilograms was used, since the toxicological endpoint of concern was gender specific. For dermal exposures, no dermal absorption factor was necessary, since the toxicological endpoint is from a dermal study. For inhalation exposures, an absorption factor of 100% was assumed. Daily dose was calculated using the following formula: Page 18 of 25 Average Daily Dose ( mg/ kg/ day) = ( Daily Exposure ( mg ai/ day) * ( Absorption Factor (%) Body Weight ( kg)

Where:

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

Margins of Exposure: Noncancer dermal and inhalation risks for each applicable handler scenario are calculated using a Margin of Exposure ( MOE), which is a ratio of the daily dose to the toxicological endpoint of concern. All MOE values were calculated separately for dermal and inhalation exposure levels using the formula below:

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

Where:

MOE = Margin of Exposure, value used by HED to represent risk or how close a chemical exposure is to being a concern ( unitless); ADD = Average Daily Dose or the absorbed dose received from exposure to a pesticide in a given scenario ( mg pesticide active ingredient/ kg body weight/ day); and NOAEL = Dose level in a toxicity study, where no observed adverse effects ( NOAEL) occurred in the study It is important to present risk estimates for each route of exposure ( i. e., dermal or inhalation) in each scenario because it makes determining appropriate risk mitigation measures easier. For example, if overall risks are driven by dermal exposures and not inhalation, it is inadvisable to require respirators even though they may marginally reduce overall risks.

A total MOE was calculated for TCMTB because common toxicity endpoints were used to calculate dermal and inhalation risks for each exposure duration. The dermal and inhalation MOEs were combined using the formula below:

MOE TOTAL = [ 1/(( Dermal MOE ) + ( 1/ Inhalation MOE))]

<IP_ADDRESS> TCMTB Noncancer Risk Summary All of the noncancer risk calculations for occupational TCMTB handlers completed in this assessment are included in the appendices. A summary of the short and intermediate term risks for each exposure scenario are presented below in Tables 4  7. Page 19 of 25 Short and Intermediate term Dermal and Inhalation Risks For commercial seed treatment, all dermal MOEs met or exceeded the required uncertainty factor of 100 at some level of mitigation. However, a few of the inhalation MOEs did not meet or exceed the required uncertainty factor of 100. Risks remain a concern for 3 scenarios even with maximum inhalation risk mitigation:

$ Multiple activities for barley, cotton, oat, rice, safflower, and wheat seeds.

For all of the on nursery seed treatment scenarios, dermal and inhalation MOEs met or exceeded the required uncertainty factor of 100 at some level of risk mitigation.

Short and Intermediate term Total Risks For commercial seed treatment, all combined dermal and inhalation risks, except for a few scenarios, did not meet or exceed the required uncertainty factor of 100 even with maximum risk mitigation. Risks remain a concern for 4 scenarios even with maximum risk mitigation:

  Loader/ Applicator activities for safflower seeds.   Multiple activities for barley, cotton, oat, rice, safflower, and wheat seeds.

For on farm seed treatment scenarios, all combined dermal and inhalation risks, met or exceeded the required uncertainty factor of 100 at some level of risk mitigation. Page 20 of 25 Table 4. Estimated Worker Exposure and Risk from Commercial Seed Treatment Short and Intermediate term MOEs c Baseline Personal Protective Equipment Engineering Controls Dermal Inhalation Crop Exposure Scenario Application Rate ( lb ai/ 100 lb) a Amount Handled per Day ( lb ai/ day) b Dermal Inhalation SL w/ gloves DL w/ gloves 80% R 90% R Dermal Inhalation Loader/ Applicator ND 18 410 520 88 180 1100 72 Sewer 1500 26 ND ND 130 260 NF NF Bagger 1000 37 ND ND 190 370 NF NF Barley, Oats Rice, Wheat Seeds Multiple Activities 0.026 187 ND 3.7 220 ND 19 37 NF NF Loader/ Applicator ND 16 370 470 79 160 980 65 Sewer 1400 23 ND ND 120 230 NF NF Bagger 920 34 ND ND 170 340 NF NF Cotton Seeds Multiple Activities 0.13 208 ND 3.4 200 ND 17 34 NF NF Loader/ Applicator ND 11 260 330 56 110 690 46 Sewer 960 17 ND ND 55 110 NF NF Bagger 650 24 ND ND 79 160 NF NF Safflower Seeds Multiple Activities 0.041 294 ND 2.4 140 ND 12 24 NF NF Loader/ Applicator ND 91 2100 2700 460 910 5600 370 Sewer 7800 130 ND ND 670 1300 NF NF Bagger 5300 190 ND ND 970 1900 NF NF Sugar Beet Seeds Multiple Activities 0.041 36 ND 19 1200 ND 97 190 NF NF ND = No Data; NF = Not Feasible a Application rates are the maximum application rates determined from EPA registered labels for TCMTB b Amount handled per day calculated from the maximum application rate and the lbs of seed treated or planted/ day and: for barley, rice, safflower, and wheat seed  718000 lb/ day; for cotton seed   160000 lb/ day; and sugar beet seed   88000 lb/ day. c Baseline Dermal: Long sleeve shirt, long pants, no gloves. Baseline Inhalation: no respirator. PPE Dermal SL with gloves: Single layer plus chemical resistant gloves. PPE Dermal DL and gloves: Coveralls worn over long sleeve shirt and long pants plus chemical resistant gloves. PPE 80% R inhalation: assumes a dust/ mist removing filtering face piece style respirator providing an 80% protection factor. PPE 90% R inhalation: assumes a dust/ mist removing half face style respirator providing a 90% protection factor. Eng Controls Dermal and Inhalation: Closed System. Page 21 of 25 Table 5. Combined Estimated Worker Dermal and Inhalation Risk from Commercial Seed Treatment Combined MOEs c Crop Exposure Scenario App Ratea ( lb ai/ lb) Amount Handled per Day b ( lb ai/ day) Baseline SL, G + NR DL, G + NR SL + 80% R SL, G + 80% R SL + 90% R SL, G+ 90% R Eng Control Loader/ Applicator ND 17 17 ND 73 ND 120 68 Sewer 26 ND ND 120 ND 220 ND NF Bagger 36 ND ND 160 ND 270 ND NF Barley, Oats, Rice, Wheat Seeds Multiple Activities 0.026 187 ND 3.6 ND ND 17 ND 32 NF Loader/ Applicator ND 15 15 ND 65 ND 110 61 Sewer 23 ND ND 110 ND 200 ND NF Bagger 33 ND ND 140 ND 250 ND NF Cotton Seeds Multiple Activities 0.13 208 ND 3.3 ND ND 16 ND 29 NF Loader/ Applicator ND 11 11 ND 46 ND 78 43 Sewer 17 ND ND 76 ND 140 ND NF Bagger 23 ND ND 100 ND 170 ND NF Safflower Seeds Multiple Activities 0.041 294 ND 2.4 ND ND 11 ND 20 NF Loader/ Applicator ND 87 88 ND 380 ND 640 350 Sewer 130 ND ND 620 ND 1200 ND NF Bagger 180 ND ND 820 ND 1400 ND NF Sugar Beet Seeds Multiple Activities 0.041 36 ND 19 ND ND 89 ND 170 NF ND = No Data; NF = Not Feasible a Application rates are the maximum application rates determined from EPA registered labels for TCMTB b Amount handled per day calculated from the maximum application rate and the lbs of seed treated or planted/ day and: for barley, rice, safflower, and wheat seed  718000 lb/ day; for cotton seed   160000 lb/ day; and sugar beet seed   88000 lb/ day.

c Baseline = No gloves and no respirator SL, G = Single layer w/ gloves is baseline attire plus chemical resistant gloves.

DL, G = Double layer w/ gloves is coveralls worn over long sleeve shirt and long pants, plus chemical resistant gloves.

80% R = 80% Respirator is dust/ mist removing filtering face piece style respirator ( that provides an 80% protection factor).

90% R = 90% Respirator is half face dust/ mist respirator ( that provides a 90% protection factor).

Eng Control = Engineering control is closed mixing/ loading system, enclosed cab, or enclosed cockpit. Page 22 of 25 Table 6. Estimated Worker Exposure and Risk from On Nursery Seed Treatment Unit Exposures Short and Intermediate term MOEs Baseline Personal Protective Equipment Engineering Controls Baseline Personal Protective Equipment Dermal ( mg/ lb ai) Inhalation ( ug/ lb ai) Dermal Inhalation Crop Acres treated/

day App Rate ( lb ai/

100 lb) a Amount Handled per dayb ( lb ai/ day) Dermalc ( mg/ lb ai) Inhalationd (

g/ lb ai) SL w/ glovese 80% Rf 90% Rg Dermalh ( mg/ lb ai) Inhalationi ( ug/ lb ai) Inhalation SL w/ gloves 80% R 90% R LOADING/ APPLYING LIQUID SEED TREATMENTS Cotton 125 0.051 0.64 NDj LOADING/ PLANTING PREVIOUSLY TREATED SEEDS Barley 35 0.026 0.64 360 7700 1800 3600 Beet; Sugar 80 0.041 0.26 1300 27000 6300 13000 Cotton 200 0.13 4.68 70 1500 350 700 Oats 200 0.026 6.66 49 1100 250 490 Rice 200 0.026 7.80 42 900 210 420 Safflower 80 0.041 3.28 100 2100 500 1000 Wheat 200 0.026 7.80 ND 3.4 0.25 0.68 0.34 NF NF 42 900 210 420 ND = No Data; NF = Not Feasible a Application rates are the maximum application rates determined from EPA registered labels for TCMTB b Amount handled per day calculated from the acres treated/ day and the maximum lb of seed planted per acre.

c Baseline Dermal: Long sleeve shirt, long pants, no gloves.

d Baseline Inhalation: no respirator.

e PPE Dermal SL with gloves: Single layer plus chemical resistant gloves.

f PPE 80% R inhalation: assumes a dust/ mist removing filtering face piece style respirator respirator providing an 80% protection factor.

g PPE 90% R inhalation: assumes a dust/ mist removing half face style respirator providing a 90% protection factor.

h Eng Controls Dermal: Closed System.

i Eng Controls Inhalation: Closed System.

j On nursery seed treatment with liquid formulations is generally done with automated equipment, essentially miniature versions of commercial treaters. Page 23 of 25 Table 7. Combined Estimated Worker Dermal and Inhalation Risk from On Nursery Seed Treatment Combined MOEs c Crop Acres treated/ day App Ratea ( lb ai/ lb) Amount Handled per dayb ( lb ai/ day) Baseline SL, G +

NR SL + 80% R SL, G + 80% R SL + 90% R SL, G+ 90%

R Eng Control LOADING/ APPLYING LIQUID SEED TREATMENTS Cotton 125 0.051 0.64 NDd LOADING/ PLANTING PREVIOUSLY TREATED SEEDS Barley 35 0.026 0.64 ND 350 ND 1500 ND 2500 NF Beet; Sugar 80 0.041 0.26 ND 1200 ND 5100 ND 8800 NF Cotton 200 0.13 4.68 ND 67 ND 280 ND 480 NF Oats 200 0.026 6.66 ND 47 ND 200 ND 340 NF Rice 200 0.026 7.80 ND 40 ND 170 ND 290 NF Safflower 80 0.041 3.28 ND 96 ND 400 ND 680 NF Wheat 200 0.026 7.80 ND 40 ND 170 ND 290 NF ND = No Data; NF = Not Feasible a Application rates are the maximum application rates determined from EPA registered labels for TCMTB b Amount handled per day calculated from the acres treated/ day and the maximum lb of seed planted per acre.

c Baseline = No gloves and no respirator SL, G = Single layer w/ gloves is baseline attire plus chemical resistant gloves.

DL, G = Double layer w/ gloves is coveralls worn over long sleeve shirt and long pants, plus chemical resistant gloves.

80% R = 80% Respirator is dust/ mist removing filtering face piece style respirator ( that provides an 80% protection factor).

90% R = 90% Respirator is half face dust/ mist respirator ( that provides a 90% protection factor).

Eng Control = Engineering control is closed mixing/ loading system, enclosed cab, or enclosed cockpit.

d On nursery seed treatment with liquid formulations is generally done with automated equipment, essentially miniature versions of commercial treaters. Page 24 of 25 2.1.3 Cancer TCMTB Handler Exposure and Risk Assessment The Health Effects Division Carcinogenicity Peer Review Committee ( CPRC) met on June 28, 1995 to discuss and evaluate the weight of the evidence on 2( Thiocyanomethylthio) benzothiazole ( TCMTB) with particular reference to its carcinogenic potential. The CPRC concluded that TCMTB should be classified as Group C  possible human carcinogen  and recommended that for the purpose of risk characterization, the Reference Dose ( RfD) approach should be used for quantitation of human risk. This was based on statistically significant increases in tumors in both sexes of the Sprague Dawley rat: testicular interstitial cell adenomas in males and thyroid c cell adenomas in females.

2.1.4 Summary of Risk Concerns/ Data Gaps for Occupational Handlers There are several occupational handler scenarios for TCMTB that have risks associated with them that are above HED's level of concern for noncancer risk assessments, even at the highest level of risk mitigation. However, there are also some occupational handler scenarios for TCMTB that have data gaps.

<IP_ADDRESS> Summary of Risk Concerns The short and intermediate term dermal and inhalation handler risk assessment for TCMTB indicates risk concerns for a number of seed treatment scenarios, even with maximum risk mitigation. See Section <IP_ADDRESS> for a detailed summary.

<IP_ADDRESS> Summary of Data Gaps One data gap was identified for TCMTB. On nursery seed treatment with liquid formulations is generally done with automated equipment, essentially miniature versions of commercial treaters. Currently, HED has no exposure data to assess this particular exposure scenario.

2.1.5 Recommendations For Refining Handler Risk Assessment The values presented in the Health Effects Division Science Advisory Committee on Exposure SOP # 15: Amount of Seed Treated or Planted per Day are most relevant to commercial seed treaters and growers planting treated seed. When assessing growers who do on farm seed treatment, the values may, in some cases, be overestimates or underestimates, depending on the crop type, geographic location and toxicity endpoint. Likewise, because of limitations on farm size/ crop type specific to the pesticide being assessed, the volume given in the tables may not be appropriate. These are cases when more detailed information regarding the pesticide application Page 25 of 25 rates, geographical/ cultural characteristics of the crop and other relevant information should be considered and modifications made to the table values on a case by case basis. For TCMTB, no chemical specific data regarding applications to seeds is currently available. In order to refine this occupational risk assessment, data on actual use patterns including rates, timing, and seeds treated per day would better characterize TCMTB risks.


[Federal Register Volume 83, Number 248 (Friday, December 28, 2018)]
[Notices]
[Pages 67293-67295]
[FR Doc No: 2018-28221]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2017-E-6003, FDA-2017-E-6016, and FDA-2017-E-6017]

Determination of Regulatory Review Period for Purposes of Patent
Extension; PARSABIV

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for PARSABIV and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
February 26, 2019. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by June 26,
2019. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for
more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 26, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 26, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''

    Instructions: All submissions received must include the Docket Nos.
FDA-2017-E-6003; FDA-2017-E-6016; and FDA-2017-E-6017, for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; PARSABIV.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, PARSABIV
(etelcalcetide). PARSABIV is indicated for secondary
hyperparathyroidism in adult patients with chronic kidney disease (CKD)
on hemodialysis. (Limitations of Use: PARSABIV has not been studied in
adult patients with parathyroid carcinoma, primary hyperparathyroidism,
or with CKD who are not on hemodialysis and is not recommended for use
in these populations). Subsequent to this approval, the USPTO received
patent term restoration applications for PARSABIV (U.S. Patent Nos.
8,377,880; 8,999,932; and 9,278,995) from KAI Pharmaceuticals, Inc. and
the USPTO requested FDA's assistance in determining the patent's
eligibility for patent term restoration. In a letter dated October 16,
2017, FDA advised the USPTO that this human drug product had undergone
a regulatory review period and that the approval of PARSABIV
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
PARSABIV is 2,335 days. Of this time, 1,801 days occurred during the
testing phase of the regulatory review period, while 534 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
September 19, 2010. FDA has verified the applicant's claim that the
date the investigational new drug application became effective was on
September 19, 2010.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: August 24,
2015. FDA has verified the applicant's claim that the new drug
application (NDA) for PARSABIV (NDA 208325) was initially submitted on
August 24, 2015.
    3. The date the application was approved: February 7, 2017. FDA has
verified the applicant's claim that NDA 208325 was approved on February
7, 2017.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 193 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition

has been served upon the patent applicant. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: December 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-28221 Filed 12-27-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 226 (Friday, November 22, 2013)]
[Notices]
[Pages 70041-70042]
[FR Doc No: 2013-28149]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9012-2]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www.epa.gov/compliance/nepa/.

Weekly Receipt of Environmental Impact Statements
Filed 11/11/2013 through 11/15/2013.
Pursuant to 40 CFR 1506.9.

    NOTICE: Section 309(a) of the Clean Air Act requires that EPA make
public its comments on EISs issued by other Federal agencies. EPA's
comment letters on EISs are available at: http://www.epa.gov/compliance/nepa/eisdata.html.

SUPPLEMENTARY INFORMATION: EPA's weekly receipt of EISs filed during
the week of 11/04/2013 through 11/08/2013 can be found in Wednesday,
November 20th, Federal Register publication and on EPA's Web site at:
http://www.epa.gov/compliance/nepa/eisdata.html.

EIS No. 20130338, Final EIS, USFS, OR, Summit Logan Valley Grazing
Authorization Project, Review Period Ends: 12/30/2013, Contact: Randall
J. Gould<PHONE_NUMBER>.
EIS No. 20130339, Draft EIS, BLM, OR, Oregon Sub-Region Greater Sage-
Grouse Draft Resource Management Plan Amendment, Comment Period Ends:
02/20/2014, Contact: Joan Suther<PHONE_NUMBER>.
EIS No. 20130340, Draft EIS, USFS, AZ, Programmatic--Revision of the
Coronado National Forest Land and Resource Management Plan, Comment
Period Ends: 02/20/2014, Contact: Yolynda Begay<PHONE_NUMBER>.
EIS No. 20130341, Final Supplement, BLM, NV, Ruby Pipeline Project,
Review Period Ends: 12/23/2013, Contact: Mark Mackiewicz<PHONE_NUMBER>.
EIS No. 20130342, Draft EIS, USA, CA, Modernization and Repair of Piers
2 and 3 at Military Ocean Terminal Concord, Comment Period Ends: 01/06/
2014, Contact: Malcolm E. Charles<PHONE_NUMBER>.
EIS No. 20130343, Draft Supplement, NPS, FL, Biscayne National Park
Supplemental Draft General Management Plan, Comment Period Ends: 02/20/
2014, Contact: Morgan Elmer<PHONE_NUMBER>.
EIS No. 20130344, Draft Supplement, FHWA, NC, Monroe Connector/Bypass,
Comment Period Ends: 01/06/2014, Contact: Jennifer Harris (NCDOT) 919-
707-6025.
EIS No. 20130345, Final EIS, DOE, LA, Lake Charles Carbon Capture and
Sequestration Project, Review Period Ends: 12/23/2013, Contact: Pieri
Fayish<PHONE_NUMBER>.
EIS No. 20130346, Draft EIS, USFS, CA, Blacksmith Forest Health
Project, Comment Period Ends: 01/06/2014, Contact: Dana Walsh 530-333-
5558.
EIS No. 20130347, Final Supplement, USFS, CA, Southern California
National Forests Land Management

Plan Amendment, Review Period Ends: 12/23/2013, Contact: Robert Hawkins
916-849-8037.
EIS No. 20130348, Draft EIS, BLM, WAPA, UT, TransWest Express
Transmission Project, Comment Period Ends: 02/19/2014, Contact: Sharon
Knowlton<PHONE_NUMBER>.

    The U.S. Department of the Interior's Bureau of Land Management and
the U.S. Department of Energy's Western Area Power Administration are
joint lead agencies for the above project.

Amended Notices

EIS No. 20130334, Draft EIS, BIA, MA, Mashpee Wampanoag Tribe Fee-to-
Trust Acquisition and Casino Project, Comment Period Ends: 01/17/2014,
Contact: Chester McGhee<PHONE_NUMBER>. Revision to the FR Notice
Published 11/20/2013; Extending the Comment Period from 12/30/2013 to
01/17/2014.

    Dated: November 19, 2013.
Cliff Rader,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2013-28149 Filed 11-21-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Pages 35682-35696]
[FR Doc No: 2018-16110]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83696; File No. 4-678]

Program for Allocation of Regulatory Responsibilities Pursuant to
Rule 17d-2; Notice of Filing and Order Approving and Declaring
Effective an Amended Plan for the Allocation of Regulatory
Responsibilities Among the Financial Industry Regulatory Authority,
Inc., Miami International Securities Exchange, LLC, and MIAX PEARL, LLC

July 24, 2018.
    Notice is hereby given that the Securities and Exchange Commission
(``Commission'') has issued an Order, pursuant to Section 17(d) of the
Securities Exchange Act of 1934 (``Act''),\1\ approving and declaring
effective an amendment to the plan for allocating regulatory
responsibility (``Plan'') filed on June 28, 2018, pursuant to Rule 17d-
2 of the Act,\2\ by the Miami International Securities Exchange, LLC
(``MIAX''), MIAX PEARL, LLC (``MIAX PEARL''), and the Financial
Industry Regulatory Authority, Inc. (``FINRA'') (collectively,
``Participating Organizations'' or ``parties''). This agreement amends
and restates the agreement entered into between FINRA, MIAX, and MIAX
PEARL on June 27, 2018, entitled ``Agreement between Financial Industry
Regulatory Authority, Inc., Miami International Securities Exchange,
LLC and MIAX PEARL, LLC Pursuant to Rule 17d-2 under the Securities
Exchange Act of 1934,'' and any subsequent amendments thereafter.
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    \1\ 15 U.S.C. 78q(d).
    \2\ 17 CFR 240.17d-2.
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I. Introduction

    Section 19(g)(1) of the Act,\3\ among other things, requires every
self-regulatory organization (``SRO'') registered as either a national
securities exchange or national securities association to examine for,
and enforce compliance by, its members and persons associated with its
members with the Act, the rules and regulations thereunder, and the
SRO's own rules, unless the SRO is relieved of this responsibility
pursuant to Section 17(d) \4\ or Section 19(g)(2) \5\ of the Act.
Without this relief, the statutory obligation of each individual SRO
could result in a pattern of multiple examinations of broker-dealers
that maintain memberships in more than one SRO (``common members'').
Such regulatory duplication would add unnecessary expenses for common
members and their SROs.
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    \3\ 15 U.S.C. 78s(g)(1).
    \4\ 15 U.S.C. 78q(d).
    \5\ 15 U.S.C. 78s(g)(2).
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    Section 17(d)(1) of the Act \6\ was intended, in part, to eliminate
unnecessary multiple examinations and regulatory duplication.\7\ With
respect to a common member, Section 17(d)(1) authorizes the Commission,
by rule or order, to relieve an SRO of the responsibility to receive
regulatory reports, to examine for and enforce compliance with
applicable statutes, rules, and regulations, or to perform other
specified regulatory functions.
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    \6\ 15 U.S.C. 78q(d)(1).
    \7\ See Securities Act Amendments of 1975, Report of the Senate
Committee on Banking, Housing, and Urban Affairs to Accompany S.
249, S. Rep. No. 94-75, 94th Cong., 1st Session 32 (1975).
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    To implement Section 17(d)(1), the Commission adopted two rules:
Rule 17d-1 and Rule 17d-2 under the Act.\8\ Rule 17d-1 authorizes the
Commission to name a single SRO as the designated examining authority
(``DEA'') to examine common members for compliance with the financial
responsibility requirements imposed by the Act, or by Commission or SRO
rules.\9\ When an SRO has been named as a common member's DEA, all
other SROs to which the common member belongs are relieved of the
responsibility to examine the firm for compliance with the applicable
financial responsibility rules. On its face, Rule 17d-1 deals only with
an SRO's obligations to enforce member compliance with financial
responsibility requirements. Rule 17d-1 does not relieve an SRO from
its obligation to examine a common member for compliance with its own
rules and provisions of the federal securities laws governing matters
other than financial responsibility, including sales practices and
trading activities and practices.
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    \8\ 17 CFR 240.17d-1 and 17 CFR 240.17d-2, respectively.
    \9\ See Securities Exchange Act Release No. 12352 (April 20,
1976), 41 FR 18808 (May 7, 1976).
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    To address regulatory duplication in these and other areas, the
Commission adopted Rule 17d-2 under the Act.\10\ Rule 17d-2 permits
SROs to propose joint plans for the allocation of regulatory
responsibilities with respect to their common members. Under paragraph
(c) of Rule 17d-2, the Commission may declare such a plan effective if,
after providing for appropriate notice and opportunity for comment, it
determines that the plan is necessary or appropriate in the public
interest and for the protection of investors, to foster cooperation and
coordination among the SROs, to remove impediments to, and foster the
development of, a national market system and a national clearance and
settlement system, and is in conformity with the factors set forth in
Section 17(d) of the Act. Commission approval of a plan filed pursuant
to Rule 17d-2 relieves an SRO of those regulatory responsibilities
allocated by the plan to another SRO.
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    \10\ See Securities Exchange Act Release No. 12935 (October 28,
1976), 41 FR 49091 (November 8, 1976).
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II. The Plan

    On November 19, 2014, the Commission declared effective the Plan
entered into between FINRA and MIAX for allocating regulatory
responsibility pursuant to Rule 17d-2.\11\ The Plan is intended to
reduce regulatory duplication for firms that are common members of both
MIAX and FINRA. The plan reduces regulatory duplication for firms that
are members of MIAX and FINRA by allocating regulatory responsibility
with respect to certain applicable laws, rules, and regulations.
Included in the Plan is an exhibit that lists every MIAX rule for which
FINRA bears responsibility under the Plan for overseeing and enforcing
with respect to MIAX members that are also members of FINRA and the
associated persons therewith (``Certification''). On January 12, 2017,
the parties submitted a proposed amendment to the Plan to add MIAX
PEARL as a Participant to the Plan.\12\
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    \11\ See Securities Exchange Act Release No. 73641 (November 19,
2014), 79 FR 70230 (November 25, 2014).
    \12\ See Securities Exchange Act Release No. 79974 (February 6,
2017), 82 FR 10417 (February 10, 2017).
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III. Proposed Amendment to the Plan

    On June 28, 2018, the parties submitted a proposed amendment to the
Plan (``Amended Plan''). The primary purpose of the Amended Plan is to
allocate surveillance, investigation, and enforcement responsibilities
for Rule 14e-4 under the Act, as well as certain provisions of
Regulation SHO. The text of the proposed Amended Plan is as follows
(additions are underlined; deletions are [bracketed]):
* * * * *

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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing. 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 protected]. Please include
File Number 4-678 on the subject line.

Paper Comments

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

All submissions should refer to File Number 4-678. 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 website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed plan that are filed with the
Commission, and all written communications relating to the proposed
plan 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 website 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 the plan also will be available for inspection and
copying at the principal offices of FINRA, MIAX, and MIAX PEARL. All
comments received will be posted without change. Persons submitting
comments are cautioned that we do not redact or edit personal
identifying information from comment submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number 4-678 and should be submitted
on or before August 17, 2018.

V. Discussion

    The Commission finds that the proposed Amended Plan is consistent
with the factors set forth in Section 17(d) of the Act \14\ and Rule
17d-2(c) thereunder \15\ in that the proposed Amended Plan is necessary
or appropriate in the public interest and for the protection of
investors, fosters cooperation and coordination among SROs, and removes
impediments to and fosters the development of the national market
system. In particular, the Commission believes that the proposed
Amended Plan should reduce unnecessary regulatory duplication by
allocating to FINRA certain examination and enforcement
responsibilities for Common Members that would otherwise be performed
by FINRA and MIAX or MIAX PEARL. Accordingly, the proposed Amended Plan
promotes efficiency by reducing costs to Common Members. Furthermore,
because MIAX, MIAX PEARL, and FINRA will coordinate their regulatory
functions in accordance with the Amended Plan, the Amended Plan should
promote investor protection.
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    \14\ 15 U.S.C. 78q(d).
    \15\ 17 CFR 240.17d-2(c).
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    The Commission notes that, under the Amended Plan, MIAX, MIAX
PEARL, and FINRA have allocated regulatory responsibility for those
MIAX and MIAX PEARL rules, set forth in the Certification, that are
substantially similar to the applicable FINRA rules in that examination
for compliance with such provisions and rules would not require FINRA
to develop one or more new examination standards, modules, procedures,
or criteria in order to analyze the application of the rule, or a
Common Member's activity, conduct, or output in relation to such rule.
In addition, under the Amended Plan, FINRA would assume regulatory
responsibility for certain provisions of the federal securities laws
and the rules and regulations thereunder that are set forth in the
Certification. The Common Rules covered by the Amended Plan are
specifically listed in the Certification, as may be amended by the
parties from time to time.
    According to the Amended Plan, MIAX and MIAX PEARL will review the
Certification at least annually, or more frequently if required by
changes in either the rules of MIAX, MIAX PEARL or FINRA, and, if
necessary, submit to FINRA an updated list of Common Rules to add MIAX
or MIAX PEARL rules not included on the then-current list of Common
Rules that are substantially similar to FINRA rules; delete MIAX or
MIAX PEARL rules included in the then-current list of Common Rules that
no longer qualify as common rules; and confirm that the remaining rules
on the list of Common Rules continue to be MIAX or MIAX PEARL rules
that qualify as common rules.\16\ FINRA will then confirm in writing
whether the rules listed in any updated list are Common Rules as
defined in the Amended Plan. Under the Amended Plan, MIAX and MIAX
PEARL also will provide FINRA with a current list of Common Members and
shall update the list no less frequently than once each quarter.\17\
The Commission believes that these provisions are designed to provide
for continuing communication between the parties to ensure the
continued accuracy of the scope of the proposed allocation of
regulatory responsibility.
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    \16\ See paragraph 2 of the Amended Plan.
    \17\ See paragraph 3 of the Amended Plan.
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    The Commission is hereby declaring effective an Amended Plan that,
among other things, allocates regulatory responsibility to FINRA for
the oversight and enforcement of all MIAX and MIAX PEARL rules that are
substantially similar to the rules of FINRA for Common Members of FINRA
and MIAX, and FINRA and MIAX PEARL. Therefore, modifications to the
Certification need not be filed with the Commission as an amendment to
the Amended Plan, provided that the parties are only adding to,
deleting from, or confirming changes to MIAX or MIAX PEARL rules in the
Certification in conformance with the definition of Common Rules
provided in the Amended Plan. However, should the parties decide to add
a MIAX or MIAX PEARL rule to the Certification that is not
substantially similar to a FINRA rule; delete a MIAX or MIAX PEARL rule
from the Certification that is substantially similar to a FINRA rule;
or leave on the Certification a MIAX or MIAX PEARL rule that is no
longer substantially similar to a FINRA rule, then such a change would
constitute an amendment to the Amended Plan, which must be filed with
the Commission pursuant to Rule 17d-2 under the Act.\18\
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    \18\ The addition to or deletion from the Certification of any
federal securities laws, rules, and regulations for which FINRA
would bear responsibility under the Amended Plan for examining, and
enforcing compliance by, Common Members, also would constitute an
amendment to the Amended Plan.
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    Under paragraph (c) of Rule 17d-2, the Commission may, after
appropriate notice and comment, declare a plan, or any part of a plan,
effective. In this instance, the Commission believes that appropriate
notice and comment can take place after the proposed amendment is
effective. The primary purpose of the amendment is to allocate
surveillance, investigation, and enforcement responsibilities for Rule
14e-4 under the Act, as well as certain provisions of Regulation SHO.
By declaring it effective today, the Amended Plan can become effective
and

be implemented without undue delay. The Commission notes that the prior
version of this plan immediately prior to this proposed amendment was
published for comment and the Commission did not receive any comments
thereon.\19\ Furthermore, the Commission does not believe that the
amendment to the plan raises any new regulatory issues that the
Commission has not previously considered.
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    \19\ See supra note 12 (citing to Securities Exchange Act
Release No. 79974).
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VI. Conclusion

    This order gives effect to the Amended Plan filed with the
Commission in File No. 4-678. The parties shall notify all members
affected by the Amended Plan of their rights and obligations under the
Amended Plan.
    It is therefore ordered, pursuant to Section 17(d) of the Act, that
the Amended Plan in File No. 4-678, between the FINRA, MIAX, and MIAX
PEARL, filed pursuant to Rule 17d-2 under the Act, hereby is approved
and declared effective.
    It is further ordered that MIAX and MIAX PEARL are each relieved of
those responsibilities allocated to FINRA under the Amended Plan in
File No. 4-678.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
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    \20\ 17 CFR 200.30-3(a)(34).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-16110 Filed 7-26-18; 8:45 am]
 BILLING CODE 8011-01-P