UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM SUBJECT: Review of Worker Exposure Study for Pentachlorophenol From: Siroos Mostaghimi, Ph. D., Environmental Engineer Team One Risk Assessment and Science Support Branch ( RASSB) Antimicrobials Division ( 7510C)

To: Adam Heyward PM# 34 Regulatory management Branch II Antimicrobials Division ( 7510C)

Thru: Winston Dang, Team Leader Team One Risk Assessment and Science Support Branch ( RASSB) Antimicrobials Division ( 7510C)

Norm Cook, Chief Risk Assessment and Science Support Branch ( RASSB) Antimicrobials Division ( 7510C)

DP Barcode: D256806 Pesticide Chemical No.: 063001 EPA MRID No.:

Review Time: 20 Days PHED: N/ A 1 of 25 2 of 23 Action Request The risk and Science Support Branch ( RASSB)) has been requested to review the PCP biomonitoring study. The following information has been provided:

Title: Inhalation Dosimetry and Biomonitoring Assessment of Worker Exposure to Pentachlorophenol During Pressure Treatment of Lumber, 321 pages Sponsor: Pentachlorophenol Task Force E. John Wilkinson Vulcan Chemicals 1101 30th Street, NW, Suite 500 Washington, DC 20007 Testing Facility: American Agricultural Services, Inc. 404 E. Chatham Street, Cary, NC 27511 Analytical Laboratory Frances Brookey Morse Laboratories, Inc. 1525 Fulton Avenue Sacramento, CA 95825 Author: Mark G. Bookbinder, Ph. D.

Report Dates: April 23, 1999 Identifying Codes: AASI Study No. AA980307; Morse Labs. Proj. No. ML98 0734 PTF CONCLUSIONS The basic premise of this study was that PCP exposure may be estimated from biological and personal air monitoring data alone. The study sponsor relied on an assumption that PCP residues excreted in human urine would have attained steady state before collection of the first sample. This assumption was, in turn, rooted in a requirement of the Study Protocol which specified that " Each monitored worker will have worked a full shift ( approximately 8 hours) on each work day of the two weeks prior to his first day of 3 of 23 monitoring" ( see page 98). However, the study report does not present an exposure history for subjects prior to biomonitoring which verifies that this aspect of the protocol was in fact enforced.

The study reported very little information about the study subjects beyond their body weight. Furthermore, the data indicate that in eight of twenty one subjects monitored, PCP levels rose significantly over the three days of urine sample collection.

Even if the protocol requirement that subjects work a minimum of 10 full shift days prior to participation was attained, this may not have been a long enough exposure period. The author states that reported half lives for urinary elimination of PCP in humans range from 33 hours to 20 days, citing ATSDR's Toxicology Profile for Pentachlorophenol. Only one of the two studies cited in the ATSDR review were referenced ( and that incorrectly) in this report. The first, Braun et al. ( 1979), actually references a study in which volunteers ingested 0.1 mg PCP/ kg. This study found a urinary excretion half life of 33 hours for PCP. The second study ( not cited by the authors) refers to a study by Begley et al. ( 1977) related to inhalation exposure experienced by wood treatment workers prior to, during, and after vacation. The urinary excretion half life for PCP reported was 19 20 days. It should be noted that the ATSDR review also references other studies that suggest that elimination of PCP is biphasic, and that the kinetics are different depending on whether occupationally exposed humans encounter a single high level exposure ( when shorter half lives can be expected) or whether chronic low level exposure occurs, in which case half lives are longer. This tends to support the supposition that the longer half life values apply to these study subjects.

It should also be pointed out that almost all ( 61/ 66) personal air sampling results returned values below the method LOD, and only one data point exceeded the LOQ, possibly due to inadequate sensitivity of the method used. Without supporting inhalation and dermal exposure monitoring data ( the latter was not collected at all), it is difficult to further assess the biological monitoring data. 4 of 23 EXECUTIVE SUMMARY This report reviews a 1999 worker exposure study sponsored by the Pentachlorophenol ( PCP) Task Force and Vulcan Chemicals, intended to quantify total worker exposure to PCP during pressure treatment of wood poles at five commercial facilities in the U. S. and Canada. PCP is a wood preservative pesticide registered for control and prevention of insect infestations and to prevent fungal decay in wood. Two PCP pressure treatment product formulations, a solid block and a liquid formulation, were used.

The field portion of the study was conducted by American Agricultural Services, Inc. between August 25 and October 21, 1998. The analytical phase was conducted by Morse Laboratories. Twenty four hour urine ( N= 63) and personal air samples ( N= 66) were collected over three consecutive days from 21 and 22 workers, respectively. These workers, distributed between the five test sites, were categorizable into five job categories. A total of 18 Treatment Operator work shifts, 6 Treatment Assistant work shifts, 15 Test Borer work shifts, 15 Load Operator work shifts, and 9 General Helper work shifts were monitored. The wood treatment process involved a total of 26 individual tasks; each job category performed some subset of these tasks.

The study was generally well written and fairly well organized. Key findings included:

( 1) Virtually all the inhalation exposure monitoring data were below the limit of detection ( LOD). Only two positive values ( N= 66) were reported, and only one data point achieved the level of quantitation ( LOQ).

( 2) Urinary PCP levels measured in this study ranged between 0.056 µ moles/ L ( the lowest detectable level) to 3.378 µ moles/ L ( N= 63). For purposes of comparison, Versar notes the following:

 Published Unexposed Levels: Analyses of urine samples from unexposed individuals ( i. e. 26 males and 43 females, ranging in age from 6 to 87 years) found PCP concentrations ranging from 0.05 to 3.6 µ g/ L ( Treble & Thompson, 1996). This is 0.187 nanomoles/ L to 0.0135 micromoles/ L in urine;

 Published Exposed Worker Levels: Maximal urinary concentrations found in seven sawmill workers where PCP was used to treat wood during a 7 month treatment season ranged from 0.2 to 0.9 µ moles/ L ( Pekari et al., 1991).

( 3) The biomonitoring data indicate that PCP levels were highest in the Treatment Assistant job category, followed by Treatment Operators; Load Operators; Test Borers; and General Helpers. This sequence was consistent with the PCP exposure potential of the tasks each group of workers performed and the number of the tasks the worker performed in the wood treatment areas. 5 of 23 ( 4) For eight of the twenty one workers monitored, PCP levels increased significantly with time over the three consecutive monitored days, suggesting that steady state levels had not been reached in these workers. Exposure estimates based on an average 24 hour urine concentration value might underestimate the total PCP exposure for these workers.

( 5) Twenty three urinary creatinine values were below, and five urinary creatinine values exceeded the normal range reported in the literature ( i. e. 15 to 25 mg/ day, Merck Manual). Individual sample coefficients of variation ( i. e. three samples per worker) ranged between 4.09 percent and 32.12 percent.

( 6) QA/ QC: Field fortified sample recoveries ranged between 73.6 percent to 94.3 percent for urine samples and between 85.2 percent to 93.3 percent for air samples. These values were used to correct field sample data for sample handling and storage losses. Laboratory fortified urine sample recoveries ranged between 101 percent to 107 percent, with a CV of 5.5 percent to 6.7 percent. The limit of detection for PCP in urine samples was 10 µ g/ L and the limit of quantitation was set at 30 µ g/ L because of the ubiquitous presence of PCP in human urine. The laboratory fortified air sampling tube sample recoveries ranged between 105 percent and 110 percent, with a CV of 1 percent to 5.9 percent. The limit of detection and limit of quantitation were 2.0 µ g/ section and 6.0 µ g/ section, respectively.

This exposure study met most, but not all, of the requirements specified in OPPTS guidelines 875.1000, 875.1300, and 875.1500. Key non compliance and other issues identified included:

( 1) It is not clear whether the air sampling methodology used was sensitive enough to successfully detect the very low levels to be expected in ( largely) outdoor exposure situations. The protocol ( see page 118) specified that the method validation target LOQ would be 1 ng/ L or 300 ng for a 5 hour sampling cycle. ( Note: The LOQ actually achieved was 6 µ g/ 372 L air, or 16 ng/ L air). Very little discussion regarding the validation of the method was provided ( see page 216). A working range ( i. e. range of air volumes required at specific air concentrations of PCP) for the method used was not given in the text. On page 146, a table of desorption efficiencies is given for the method at 0.5, 1.0 or 2.0 mg/ m3 PCP in air, however, these air concentrations are much higher than those measured in this study.

For comparison, the NIOSH Method # 5512 recommends use of a mixed cellulose ester filter and a 25 mL bubbler containing ethylene glycol, and has a working range of 130 µ g to 1,130 µ g/ m3 in 180 L air samples. [ The NIOSH method is intended for use at higher air levels of PCP, such as those in the general range of the OSHA PEL ( i. e. 500 µ g/ m3), and these methods are best applied in high exposure indoor venues.] 6 of 23 ( 2) No dermal exposure monitoring was performed. Guideline 875.1500 specifically requires that both dermal and inhalation exposure studies be conducted along with biological monitoring. Without supporting inhalation and dermal exposure monitoring data, it is difficult to assess the biological monitoring data.

( 3) The basic premise of the study was that " total exposure" could be determined by measuring a three day average, steady state PCP concentration in human urine. It could not be confirmed that all study subjects steady state had been reached prior to biomonitoring. According to the protocol, study subjects were qualified for participation only if they had worked " full shift ( approximately 8 hours) on each work day of the two weeks prior to..." study initiation. No work exposure history was provided, so that this key issue could not be verified.

( 4) Pharmacokinetic data for PCP were not presented or reviewed in any detail, and published data were not well described when cited. The author cites urinary elimination half lives for PCP ranging between 33 hours and 20 days ( ATSDR, 1997) Further examination of these values finds that the former value relates to oral administration of PCP to a small number of fasting subjects, and the latter value relates to inhalation exposure. It is likely that the longer half life value is more relevant to the exposures described in this study.

( 5) Little information beyond body weight was available about the study subjects ( e. g., exposure history, sex, etc.). Very little information was available on personal protective equipment ( PPE) worn by workers; footnotes in data tables contain the only description of PPE worn by workers, and only at two of the test sites.

( 6) According to a 1984 study conducted by U. S. EPA OPTS ( cited in the study report), a typical 87 kg wood treatment worker would be expected to adsorb between 112 and 293 µ g PCP/ kg body weight/ day by all routes. This range of PCP exposure was much higher than the highest total absorption of 15.3 µ g PCP/ kg body weight/ day reported in this study. The discrepancy was not explained in the study report.

( 7) Guideline 875.1500 specifically requires that 15 replicates be evaluated for each exposure scenario. Six Treatment Assistant replicates and nine General Helper replicates were used to evaluate PCP exposures in the study.

( 8) Guideline 875.1300 for inhalation exposure outdoor requires that inhalation absorption be normalized from the pump rate of 1.0 L/ min to an inhalation rate of 1,740 L per minute for light work. In this study, the inhalation absorption was normalized to 1,000 L per minute. 7 of 23 STUDY REVIEW Background Pentachlorophenol ( PCP) is a wood preservative pesticide registered for the pressure treatment of certain wood products to control and prevent insect infestation and prevent fungal decay in wood. The stated purpose of this study was to quantify the total worker exposure to PCP during pressure treatment and butt treatment of wood poles at five commercial facilities. Results are to be used in support of reregistration of pentachlorophenol.

This study was sponsored by the Pentachlorophenol Task Force and Vulcan Chemicals. The field portion of the study was conducted by American Agricultural Services, Inc. between August 25 and October 21, 1998. The analytical phase was conducted by Morse Laboratories. Field trial notebooks and raw data are to be archived at the Crystal City, VA facility of SRA International, Inc.

Study Setting This exposure study was conducted at five facilities: three pressure treatment facilities in the U. S. ( i. e. Bay Minette, Alabama; New Brighton, Minnesota; Arlington, Washington) and two facilities in Canada ( i. e. New Westminster and Prince George, British Columbia), designated as Facilities A, B, C, D, and E, respectively. These facilities were selected to represent the spectrum of treatment processes currently practiced in North America.

Urine ( N= 63) and personal air samples ( N= 66) were collected over three consecutive days from 21 and 22 workers, respectively. Urine PCP levels and inhalation exposure was calculated for each job category of workers, statistically analyzed and ranked to profile PCP exposure scenarios at the wood treatment facilities.

Wood Treatment Process Table I of the study report profiles PCP formulations and equipment used, and treatment practices at each pressure treatment facility. Two formulations were used in this study. The first was a 1 ton solid product containing 86% active ingredient ( a. i.) PCP ( Vulcan Block Penta ® ) and the second was a liquid formulation containing 34.4 percent a. i. PCP ( Pentacon 40 Liquid). The former was diluted in either P 9 oil or Number 2 Oil, while the latter was diluted in Number 2 Oil only. The final PCP content of the treatment solutions " varied with the facility and the species of wood treated, and ranged between 5.00 percent and 7.48 percent."

At each site, pressure treatment of poles was performed by the same basic process. Workers stacked untreated poles onto wheeled metal trams on railroad tracks leading into the treatment cylinders . The 8 of 23 trams were then pulled into the cylinders and the cylinder doors closed. Treating solution was pumped from storage tanks into the cylinder at high pressure ( 85 175 PSI), and allowed to permeate the wood of the poles for 4 24 hours at elevated temperatures ( 180 220 0F) or at ambient temperature. After treatment, excess treating solution was removed from the cylinders and poles by maintaining vacuum in the cylinder for several hours. The treated poles on trams were then pulled onto a concrete drip pad, where excess treating solution was allowed to drip from the poles and trams. After the treated poles cooled, the treated poles were transported to the storage area. To determine the content and depth of penetration of PCP, workers collected wood core samples from selected poles using electrically powered drills. If the treatment did not meet specifications, the wood poles were retreated. The treatment parameters for each charge of wood poles in five facilities are provided in Table II of the study report.

The number of charges of wood poles treated at each site and the quantity of PCP retained by wood poles in each site during the monitoring period are summarized in Table 1, below.

Table 1. Number of Charges Treated and Quantity of PCP Retained by Wood Poles in Each Facility During the Monitoring Period Test Site Charges fully or Partially Monitored Total lb treatment solution retained Total lb PCP retained Mean lb PCP retained/ charge A 8 5697 303 37.9 B 4 38610 1931 483 C 5 64592 4775 955 D 3 20047 1243 414 E 14 27728 1525 109 Study Demographics The pressure treatment process consisted of 26 specific tasks, each having different worker exposure. Twenty two workers were sorted into five job categories ( see Table 2, below) at five commercial facilities. Job categories were: Treatment Operator; Treatment Assistant; Loader Operator; Test Borer; and General Helper. [ The suite of work tasks performed by each worker at all five facilities were recorded by study personnel; see Tables III to Tables VII of the study report]. The main tasks performed by each job category of workers and the number of worker cycles monitored are summarized in Table 3, below. Based on the nature and number of work tasks performed, Treatment Operators and Treatment Assistants were most likely to experience the highest exposures to PCP. 9 of 23 PCP exposure was monitored during a total of 20 Treatment Operator work shifts, 6 Treatment Assistant work shifts, 15 Test Borer work shifts, 15 Load Operator work shifts, and 9 General Helper work shifts. Details on all work shifts monitored are summarized in Table XIV of the study report.

Table 2. Workers Monitored in Each Wood Treatment Facility Workers Monitored on Each Site Facilit y ID Treatment Operator Treatment Assistant Tester Borers Loader Operator General Helpers Total Number of Workers A 1 1 1 1 1 5 B 1  1 1 2 5 C 1  1 1 1 4 D 1  1 1  3 E 2 1 1 1  5 Engineering Controls and Personal Protective Equipment The author stated ( see pg. 12): "... each subject wore the work clothing and protective clothing and equipment that he/ she would normally wear while working..." Footnotes on Tables III to VII state that: 1) At Site A: Treatment Operators and Treatment Assistants wore uniforms, rubber gloves and goggles when close to PCP, and Test Borers wore rubber gloves to take cores; 2) At Site E: Treatment Operators, Treatment Assistants and Test Borers wore short sleeved shirts, Treatment Assistants wore leather gloves to handle cylinder doors and leads, and Test Borers did not wear gloves to take sample cores. No further information was provided concerning protective clothing worn or equipment used by the workers.

It should be noted that all of the Facilities were either entirely open or roofed, except for Facility C, where the treatment process was housed in a totally enclosed building.

Meteorology The study authors provided three such data sets. The first was on site ambient weather data, including: minimum/ maximum/ mean insolation, windspeed ( range = 3.1 to 12.8 mph) and direction; air temperature ( range = 39 to 78.6 F.); and relative humidity ( range = 53.8 percent to 97 percent). The second data set 10 of 23 reflected data from test site vicinity airports, including: miles to weather station, air temperature, percent relative humidity, windspeed and direction. Finally, minimum and maximum air temperature and relative humidity were measured at three locations inside the Facility C enclosed building. 11 of 23 Table 3 Job Categories Monitored during the Study Period Job Category Tasks Performed Potential for Exposure Replicates Analyzed Work Cycles Monitored Treatment Operator Open/ close cylinder doors High urine = 18 air = 19 20  all sites Clean PCP residues from cylinders High Open valves to transfer PCP treating solution between tanks and cylinders Low Perform tram maintenance/ positioning High Move lumber between treatment cylinders and drip pads High Treatment Assistant Perform many work tasks also performed by Treatment Operators High 6 6  sites A & E Mix treating solutions High Filter cleaning and drip pad cleaning high Load Operator Operate self propelled vehicles to move poles onto and off the trams Low 15 15  all sites Move charges into and out of the treatment cylinders using self propelled loaders. Low Perform certain out of cab tasks such as handling chains and tram placements High Test Borer Take pole cores to test for PCP penetration High 15 15  all sites 12 of 23 Routinely test PCP samples in labs Low Perform other laboratory & QC duties Low General Helpers Occasional  perform various labor and cleanup duties in treatment areas High 9 9  sites A & B Routinely  Perform labor and cleanup duties in areas other than the treatment areas Low TOTAL: work shifts monitored; samples urine = 63 air = 64 65 Exposure Monitoring Procedures 1. Biological Monitoring On each monitoring day, individual workers were provided with a Urisafe ® urine collection container and a storage cooler stocked with blue ice. All the urine voided within 24 hours was collected and stored in the coolers. The study personnel collected all urine samples from workers the following day and measured the volume of urine samples. Urine samples were acidified by adding 3 drops of 37% aqueous HCl per 100 mL of urine and then frozen.

2. Air Monitoring While performing his/ her tasks, each worker was equipped with an air sampling device consisting of a silica gel air sampling tube ( SKC# 226 22) and an air pump. The inlet of the air sampling device was attached to the worker's collar and positioned downward, and the pump was attached to the worker's belt. Air sampling was conducted at a flow rate of 1.0 L per minute. Study personnel calibrated and started air pumps at the beginning of a day and recorded the air sampling time at the end of the day.

QA/ QC Sample Handling & Storage Urine samples were stored on blue ice in coolers. Field study staff received the samples in coolers from workers. Urine samples were then refrigerated, acidified, labeled, caps sealed, and placed inside locking polyethylene bags. Aliquots were stored in Qorpak # 7892T fluorinated high density polyethylene bottles, also on ice. Air samples and urine samples were then frozen in a cooler containing dry ice and shipped on 13 of 23 dry ice to Morse Laboratories, Inc. for extraction and analysis. Samples were stored at  15 C. to  25 C. and extracted within 27 days of collection. Creatinine levels in worker urine samples were determined as a QC procedure to gauge whether all urine voided within 24 hours were collected.

Sample History Table VIII of the study report chronicles sample collection dates, shipment dates, dates received at the laboratory, extraction and analysis dates. Most samples were analyzed within two to three weeks.

Test Product Analysis The protocol required that samples of the test substance and finished application mixture ( 50 100 mls) be collected at each test site from each lot of test substance used. Analytical results were not available for review.

Trapping Efficiency  Air Sampling Tubes Trapping efficiency was determined by connecting two silica gel tubes in series. The front tube was spiked with either 60 or 6000 µ g/ section levels of PCP and then connected in series to the rear tube. The tubes were then attached to an air sampling pump, which was operated for five hours at a flow rate of 1 L per minute. The percent of PCP migrating into the rear air sampling tubes was determined. The results ( see Table XI of the study report) suggest that 100 percent of airborne PCP residues were trapped by the front air sampling tube.

Analytical Methodology The method used to analyze the urine samples was proprietary ( i. e. Morse Method Meth 113, Rev. 2, dated July, 1998, see page 137), as was the air sample analysis method ( i. e. Morse Method Meth 114, dated July, 1998, see page 262). The latter method was based on an older method ( Vulcan Materials Co., Determination of Pentachlorophenol in Ambient Air, Method: PENTA 90, File # 903.18, March 1, 1982).

1. Urine Samples: A 300 uL aliquot of each urine sample was mixed with sodium bisulfite, acidified and digested under heat with concentrated HCL ( to hydrolyze PCP conjugates), extracted with benzene, and an aliquot of the organic layer was transferred to a solid phase extraction column. The column was eluted with benzene/ ethyl acetate, and evaporated to dryness, 300 uL of MTBSTFA was added to the solution to convert PCP to its t butyldimethylsilyl derivative. The derivative was quantified via gas chromatography and mass selective detection.

2. Air Samples: PCP residues ( vapor and particulate) were extracted from silica gel sorbent by sonicating in 25 mL of acetonitrile for 20 minutes. An aliquot of the extract was then analyzed by a high performance liquid chromatography ( HPLC) with using a 3 cm X 4.6 mm Brownlee Spheri 5 Amino column and UV detection at 254 nm. 14 of 23 Limits of Detection ( LOD) and Quantitation ( LOQ)

1. Urine Samples: The LOD for PCP in urine samples was 10 µ g/ L. Because PCP is ubiquitous in the environment, and background levels of PCP were present in all urine samples during method development, the LOQ was set at 30 µ g/ L.

2. Air Samples: The LOD was 2.0 µ g/ section. The LOQ was 6.0 µ g/ section.

Laboratory Recovery 1. Urine Samples: The analytical method for PCP in urine samples was validated by fortifying sets of seven unexposed urine samples at levels of 0, 30, 60, and 600 µ g/ L ( see Table IX of the study report). Laboratory fortification recoveries are summarized in Table 4, below.

2. Air Samples: The analytical method for PCP in air sampling tubes was validated by spiking sets of seven silica gel filled air sampling tubes at levels of 0, 6, 60, 600 µ g/ section. The laboratory fortification air sample recoveries can be found in Table X of the study report and are also summarized in Table 4, below.

Table 4. Laboratory Fortification Sample Recoveries  Urine and Air Samples Amount Added ( µ g/ L) Percent Recovery of PCP from Urine Samples Amount Added ( µ g/ L) Percent Recovery of PCP from Air Sampling Tubes Mean Std. Deviation % CV Mean Std. Deviation % CV 0 < LOQ n/ a n/ a 0 < LOQ n/ a n/ a 30 106 6.96 6.6 6 107 1.11 1 60 107 5.88 5.5 60 105 1.72 1.6 600 101 6.74 6.7 600 110 6.74 5.9 Field Fortification Recovery Recovery values obtained for both field fortified urine samples and air sampling tubes from four of the five facilities were reported in Table XVIII and Table XIX of the study report. The data are summarized in Table 5, below. Note: There were no fortified field recovery samples collected from Facility D because urine samples and spiking solutions were delivered too late to the site ( due to a shipping problem). 15 of 23 In these tables, " Field Controls" were fortified in the field, held on blue ice for 24 hours, then frozen. " Traveling Controls" were fortified and immediately frozen.

Recovery values for both fortified urine and air sampling tubes were all within the allowable tolerance ( i. e. 75 percent to 125 percent) specified by OPPTS guidelines. The mean recoveries for each site were used to correct urine samples or air inhalation samples for losses of PCP during sample handling.

1. Urine Samples: Field fortified samples ( i. e. 0, 30, 60, and 600 µ g/ L) were prepared in 100 mL of control urine from unexposed subjects.

2. Air Samples: Field fortified samples were spiked with 0, 60, or 3,000 µ g PCP per tube. The fortified air sampling tubes were connected to an air sampling pump and purged with air for 5 hours at a flow rate of 1 Liter per minute before shipment to the laboratory along with field samples.

Storage Stability Recovery The stability of PCP in urine samples and air sampling tubes within the sample storage period of 30 days was tested. The results shown in Table XIII of the study report suggested that PCP was stable within 30 days.

Table 5 Field Fortification Sample Recoveries  Urine and Air Samples Test Site Percent Recovery of PCP from Urine Samples Percent Recovery of PCP from Air Sampling Tubes Mean Standard Deviation Mean Standard Deviation A 84.8 7.2 93.3 7.8 B 73.6 5.5 85.2 3.74 C 87.3 7.7 85.7 24.8 E 94.3 11.2 87.2 15.9 Calculations " Total PCP exposure" was estimated from steady state PCP residues measured in urine samples ( see Table XXII in the study report). Raw PCP urinary levels were divided by the daily urinary output ( Liters/ day). The PCP concentration values were corrected for field fortification recovery. Dividing by the individual subject's body weight ( kg) yielded a " total exposure" value. The urine concentration values were adjusted with an 86 percent factor to account for the fraction of the dose excreted. [ The origin of the latter value was not fully discussed in the study report and an incorrect citation was given 16 of 23 ( Braun, et al. ( 1978) should be Braun, et al. ( 1979)).] In the Braun et al. ( 1979) study, fasting volunteers ingested 0.1 mg/ kg sodium pentachlorophenate. Residues appeared in the urine ( 74 percent as pentachlorophenol, 12 percent as a PCP glucuronide conjugate) and 4 percent in feces. Note: This value may not be appropriate where residues are primarily dermally absorbed as in this study.]

" Daily inhalation exposure" data may be found in Table XXV in the study report. The author states that "... values less than the LOD ( i. e. 2 µ g/ section) are expressed as 1 µ g for calculation purposes. Values less than the LOQ ( i. e. 6 µ g/ section) are expressed as 3 µ g/ section for calculation purposes. If all tubes in a monitoring period contained residues less than the LOD, the entire period was assigned a value of 1 µ g for calculation." Air concentrations of PCP were normalized over an 8 hour workday, and worker exposure values were calculated by dividing by the individual worker's body weight, and by scaling up the pump rate of 1 liter/ minute ( 60 liters/ hour) to an inhalation rate of 1,000 L per hour for light work. It should be noted that OPPTS guideline 875.1300 requires that normalization calculations employ a standard breathing rate of 1,740 L per hour for light work.

RESULTS Biological Monitoring PCP residues in three consecutive 24 hour urine samples from 21 workers ( i. e. 63 samples) were quantified, and a PCP exposure value was calculated for each worker ( see Table XXII of the study report). The author identified this value as " Total PCP Exposure." Values for each job category of workers are summarized in Table 6, below.

° Urinary PCP levels measured in this study ranged between 0.056 umoles/ L ( the lowest detectable level) to 3.378 umoles/ L ( N= 63). For purposes of comparison, Versar notes the following:

 Published Unexposed Levels: Urine samples from unexposed individuals ( i. e. 26 males and 43 females, ranging in age from 6 to 87 years) found PCP concentrations ranging from 0.05 to 3.6 µ g/ L ( Treble & Thompson, 1996). This is 0.187 nmoles/ L to 0.0135 umoles/ L in urine;

 Published Exposed Worker Levels: Maximal urinary concentrations found in seven sawmill workers where PCP was used to treat wood during a 7 month treatment season ranged from 0.2 to 0.9 µ moles/ L ( Pekari et al., 1991).

° PCP levels in urine were highest in Treatment Assistants, followed by Treatment Operators; Load Operators; Test Borers; and General Helpers. This sequence was consistent with the PCP exposure potential of the tasks each group of workers performed and the number of the tasks the worker performed in the wood treatment areas.

° Table XXII of the study report indicates that for eight of twenty one workers monitored, PCP levels increased significantly with time over the three consecutive monitored days, suggesting that steady state levels had not been reached in these workers. Exposure estimates based on an average 24 hour 17 of 23 urine concentration value might underestimate the total PCP exposure for these workers.

° Creatinine levels in each urine sample are provided in Table XXIII of the study report. The author did not interpret these data. However, according to the Merck Manual, the normal range for urinary creatinine values is 15 to 25 mg/ day. Five values were found below the lower limit of this range. Twenty three values were found below the upper limit of this range. Individual sample coefficients of variation ( i. e. three samples per worker) ranged between 4.09 percent and 32.12 percent.

Table 6. " Total" PCP Exposure as Estimated from Biomonitoring Results In Five Job Categories at Wood Treatment Facilities Parameters " Total" PCP Exposure1 ( µ g/ kg/ day)

Treatment Assistant Treatment Operator Load Operator Test Borers General Helpers # Replicates 6 18 15 15 9 Minimum 3.78 1.45 0.2 0.42 0.58 Maximum 24.5 12 8.4 5.27 2.16 Arith. Mean 15.3 4.81 2.69 2.39 1.39 Std Deviation 6.83 3.68 2.8 1.65 0.531 1. Corrected for field spike recovery and 86% absorption rate value Personal Air Monitoring Tables XXIV and XXV of the study report summarize personal air sampling data collected. PCP inhalation exposure data are summarized below in Table 7.

PCP residues in air sampling tubes were below LOD ( 2 µ g/ section) for all workers except for two Treatment Operators ( one at Facility A and the other at Facility C), for whom the residue levels in air sampling tubes were above the LOD but at or below the LOQ. This is consistent with the fact that Treatment Operators and Treatment Assistants were the workers closest to the PCP sources while performing their tasks. 18 of 23 Table 7. Inhalation Exposures to PCP among Five Wood Treatment Job Categories Parameter s Inhalation Exposure ( µ g/ kg body weight/ day)

Treatment Operator Treatment Assistant Test Borers Load Operator General Helpers # Replicates 19 6 15 15 9 Arith. Mean 0.3 0.215 0.173 0.162 0.185 Std Deviation 0.336 0.047 0.041 0.036 0.03 It should be noted that the maximum inhalation exposure was 1.62 µ g/ kg day, measured in a single day's sample from a Treatment Operator at Facility A. This was also the only value ( 1/ 66) that reached the limit of quantitation for PCP in an air sample.

COMPLIANCE Compliance with OPPTS Series 875, Occupational and Residential Exposure Test Guidelines, Group A: Applicator Exposure Monitoring Test Guidelines ( i. e. Subdivision U); Guidelines, 875.1000, 875.1300, and 875.1500, is critical for determining whether a study is acceptable to the Agency. The itemized checklist below describes compliance with the major technical aspects of these guidelines 875.1000 " Background for Application Exposure Monitoring Test Guidelines ° Informed consent is required. This criterion was met. Twenty two workers who participated in this study were provided with a consent form which detailed the nature of the study. A copy of a ( nonexecuted example form was available for review.

° The product must be handled and applied using recommended equipment, application rates, and typical work practices, as specified on the label. This criterion was met. One of two formulations, either the solid block PCP formulation ( Vulcan Block Penta ® ) or the liquid formulation ( Pentacon 40 ® ) , was mixed with light oil and applied onto wood poles according to the instructions on the labels. The labels for both PCP formulations were provided in the study report.

° Study conditions must be consistent with typical use of the product. This criterion was met. The study was conducted with liquid and solid block PCP formulations at commercial facilities under the normal conditions specified in the labels. 19 of 23 ° The monitoring period must be appropriate for the substance tested  sufficient to collect measurable residues but not excessive so that residue loss occurs. This criterion was met. Biological monitoring was conducted over three consecutive 24 hour days. Inhalation exposure monitoring periods ranged between 323 and 553 liters of air ( target air flow rate was 60 liters/ hour).

° Exposure should be measured for each different activity, whenever possible. This criterion was partially met. The pressure treatment of wood poles with PCP involves a combination of 26 types of tasks with differing potential for PCP exposure. These tasks were performed by five job categories of worker performing various combinations of some subset of these 26 tasks.

° For outdoor exposure monitoring, at least five replicates from each of at least three sites for each job function .... should be monitored...... Each exposure situation must be evaluated using at least 15 replicates. This criterion was partially met. Five workers were monitored at three of five sites; at two others only three or four subjects were monitored.

875.1300 " Inhalation Exposure  Outdoor"

° The analytical procedure must be capable of measuring exposure to 1 µ g/ hr. This criterion was met. The limit of quantitation for air sampling tubes was 6 µ g/ section. The tubes were used for a 8 hour period. Thus, the analytical method used in this study was capable of measuring exposure of 0.75 µ g per hour.

° Trapping efficiency for monitoring media must be documented. This criterion was met. The trapping efficiency study was documented in section 2.3.2 ( Method Validation) of this study report.

° Air sampler should be tested for breakthrough. This criterion was met. The breakthrough study for PCP in silica gel air sampling tubes was conducted. The results indicate that 100 percent of PCP collected on the front section of the air sampler did not escape to the rear section of the air sampler.

° Extraction efficiency is considered acceptable if the lower limit of the 95% confidence interval is greater than 75 percent, based on a minimum of seven replications per fortification level, used to calculate the mean and standard deviation for recovery. This criterion was met. The lower limit of the 95 percent confidence interval developed from seven replicates per fortification level was greater than 75 percent for all three fortification levels of 6, 60, 600 µ g/ section.

° If trapping media are to be stored after exposure, a stability test for PCP must be documented. Media must be stored under the same conditions as field samples. Replicate samples should be extracted and analyzed immediately before and at appropriate periods during storage. This criterion was probably met. A stability test for PCP residues in urine samples and air sampling tubes was conducted under the same conditions as field samples and documented in the study report. However, the data were not available for review. 20 of 23 ° If extracts from field samples are to be stored prior to analysis, a stability test must be conducted. Extracts of fortified samples are stored under the same conditions as the extracts from field samples. Each sample should be analyzed immediately before and at appropriate times during storage. This criterion was probably satisfied. Extracts were stored for anywhere between 1 day and 11 days ( see page 58 of the study).

° Appropriate air sampling media should be selected. This criterion was partially met. A proprietary sampling and analytical method was used which specified use of silica gel sorbent tubes. This medium has been used to collect PCP. NIOSH Method 5512 notes, without comment, that such media " was used by a NIOSH contractor for analyzing samples containing pentachlorophenol." However, it is questionable whether the method was adequately sensitive under the conditions of the study.

° Personal monitors should be arranged with the intake tube positioned downward, near the nose level of the subject. This criterion was met.

° Field calibration of personal monitors should be performed at the beginning and the end of the exposure period. This criterion was met. Air sampling pumps were pre and post calibrated.

° Field fortification samples and blanks are analyzed for correction of residue losses occurring during the exposure period. Fortified samples and blanks should be fortified at the expected residue level of the actual field samples. Fortified blanks should be exposed to the same weather conditions, but in a clean environment. This criterion was partially met. Field fortified urine and air sampling tube samples were prepared and exposed to the simulated field conditions. The field fortification recoveries were used to correct for residue losses during the exposure period. However, most of the data were non detect and fortification levels were much higher than in the few positive samples.

° Field data should be documented, including chemical information, area description, weather conditions, application data, equipment information, information on work monitored, sample numbers, exposure time, and any other observations. These criteria were met.

° A sample history sheet must be prepared by the laboratory upon receipt of samples. This criterion was met.

° The analytical method should be documented and appropriate. This criterion was partially met. The analytical method was documented, and reportedly, validated before the initiation of the study. However, when it was validated, and what the results were, was not clear. The validation data were not available for review.

° For outdoor exposure monitoring, at least five replicates at each of at least three sites for each job function should be monitored. This criterion was partially met. Five subjects were monitored over three days at three of the five sites. Three and four subjects were monitored at the other two sites. 21 of 23 875.1500 " Biological Monitoring"

° Study feasibility should be based on information on chemical profiles such as metabolism and excretion. This criterion was partially met. The author did not thoroughly review PCP metabolism and excretion, and some information cited was not accurately represented. No data relating to dermal absorption were presented.

° Pharmacokinetics testing is necessary before field studies are initiated. This criterion was not met.

° Biomonitoring data must be supported by dermal and inhalation exposure data. This criterion was not met.

° The potential for adsorption of the test substance or urinary metabolites to the collection bottles, stability, and recovery from the sampling medium, and possible breakdown during storage should be considered. This criterion was met. Field fortified urine samples were prepared and the recoveries were used to correct for any possible losses during handling, shipping, and storage of urine samples.

° Urine collection should continue for a full 24 hour period. At least one baseline pre exposure 24 hour urine sample should be collected. Sample completeness can be determined by measuring creatinine levels in urine samples. This criterion was partially met. No baseline pre exposure 24 hour urine samples were collected from the workers in this study. Creatinine levels in urine samples were determined, but not interpreted.

° For outdoor exposure monitoring, at least five replicates at each of at least three sites for each job function ... should be monitored. Each exposure situation must be evaluated using at least 15 replicates. This criterion was partially met. Five subjects were monitored over three days at three of the five sites. Three subjects each were monitored at the other two sites.

DATA GAPS AND OTHER ISSUES Additional issues and concerns not mentioned above are summarized below:

° The basic premise of the study was that " total exposure" could be determined by measuring a threeday average, steady state PCP concentration in human urine. According to the protocol, study subjects were qualified for participation only if they had worked " full shift ( approximately 8 hours) on each work day of the two weeks prior to..." study initiation. It is probable that for at least eight of twenty two subjects, steady state had not been reached prior to biomonitoring. No work exposure history was provided, so that this key issue could not be verified. Since the reported half lives for urinary elimination of PCP in human range from 33 hours to 20 days ( ATSDR, 1997), if steady state had not been achieved, PCP exposure may have been underestimated.

° References cited in this report were few and those cited were not extremely helpful in interpreting the 22 of 23 data. This is surprising given the wealth of information on biological monitoring for pentachlorophenol.

° Background information about the urinary elimination rate of PCP ( 86 percent) used to correct the raw data was not fully described in the study report. It appears that this value relates to an oral administration of PCP to fasting subjects. Dermal exposure may have been a more important route of exposure for study subjects.

° Guideline 875.1500 specifically requires that 15 replicates be evaluated for each exposure scenario. Six Treatment Assistant replicates and nine General Helper replicates were used to evaluate PCP exposures.

° It is not clear whether the air sampling methodology used was sensitive enough to successfully detect the very low levels to be expected in a ( largely) outdoor exposure situation. The protocol ( see page 118) specified that the method validation target LOQ would be 1 ng/ L or 300 ng for a 5 hour sampling cycle. ( Note: The LOQ actually achieved was 6 µ g/ 372 L air, or 16 ng/ L air). Very little discussion regarding the validation of the method was provided ( see page 216). A working range ( i. e. range of air volumes required at specific air concentrations of PCP) for the method used was not given in the text. On page 146, a table of desorption efficiencies is given for the method at 0.5, 1.0 or 2.0 mg/ m3 PCP in air, however, these air concentrations are much higher than those measured in this study.

For comparison, the NIOSH Method # 5512, which recommends use of a mixed cellulose ester filter and a 25 mL bubbler containing ethylene glycol, has a working range of 130 µ g to 1,130 µ g/ m3 in 180 L air samples. The NIOSH method is intended for use at higher air levels of PCP, such as those in the general range of the OSHA PEL, which is 500 µ g/ m3. The NIOSH methods are best applied in high exposure, indoor, venues.

In this study, only one of 64 samples was quantifiable at the LOQ (~ 16 µ g/ m3).

° Guideline 875.1300 for inhalation exposure outdoor requires that inhalation absorption be normalized from the pump rate of 1 L/ min to an inhalation rate of 1,740 L per minute for light work. In this study, the inhalation absorption was normalized to 1,000 L per minute.

REFERENCES ATSDR. ( 1994). Toxicological Profile: Pentachlorophenol ( update). Department of Health & Human Services, Atlanta, GA.

Begley J, Reichert AW, Siesmen AW, et al. 1977. Association between renal function tests and pentachlorophenol exposure. Clin Toxicol 11: 97 106.

The Merck Manual of Diagnosis and Therapy. ( 1977). Eds: Berkow R. and Talbott JH. Rahway, NJ: 23 of 23 Merck, Sharp and Dohme Research Laboratories.

Pekari K; Luotamo M; Jarvisalo J, Lindroos L, Aitio A. ( 1991). Urinary excretion of chlorinated phenols in saw mill workers. Int. Arch. Occup. Environ. Health 63( 1): 57 62.

Treble RG, Thompson TS. ( 1996). Normal values for pentachlorophenol in urine samples collected from a general population. J. Anal. Toxicol. 20( 5): 313 317.

File: C:\\ myfiles\ 2000 reports\ Review of PCP Biomonitoring Study. wpd CC: Siroos Mostaghimi\ RAASB\ AD Chemical Files


[Federal Register Volume 83, Number 142 (Tuesday, July 24, 2018)]
[Proposed Rules]
[Pages 34968-34974]
[FR Doc No: 2018-15722]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0006; FRL-9980-31]

Receipt of Several Pesticide Petitions Filed for Residues of
Pesticide Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of filing of petitions and request for comment.

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

SUMMARY: This document announces the Agency's receipt of several
initial filings of pesticide petitions requesting the establishment or
modification of regulations for residues of pesticide chemicals in or
on various commodities.

DATES: Comments must be received on or before August 23, 2018.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the pesticide petition number (PP) of interest as shown
in the body of this document, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and
Pollution Prevention Division (BPPD) (7511P), main telephone number:
(703) 305-7090; email address: [email protected]., Michael Goodis,
Registration Division (RD) (7505P), main telephone number: (703) 305-
7090; email address [email protected]. The mailing address for each
contact person is: Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT for the division listed at the end of the
pesticide petition summary of interest.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. What action is the Agency taking?

    EPA is announcing its receipt of several pesticide petitions filed
under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a, requesting the establishment or modification of
regulations in 40 CFR part 180 for residues of pesticide chemicals in
or on various food commodities. The Agency is taking public comment on
the requests before responding to the petitioners. EPA is not proposing
any particular action at this time. EPA has determined that the
pesticide petitions described in this document contain the data or
information prescribed in FFDCA section 408(d)(2), 21 U.S.C.
346a(d)(2); however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data support granting of the
pesticide petitions. After considering the public comments, EPA intends
to evaluate whether and what action may be warranted. Additional data
may be needed before EPA can make a final determination on these
pesticide petitions.
    Pursuant to 40 CFR 180.7(f), a summary of each of the petitions
that are the subject of this document, prepared by the petitioner, is
included in a docket EPA has created for each rulemaking. The docket
for each of the petitions is available at http://www.regulations.gov.
    As specified in FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA
is publishing notice of the petitions so that the public has an
opportunity to comment on these requests for the establishment or
modification of regulations for residues of pesticides in or on food
commodities. Further information on the petitions may be obtained
through the petition summaries referenced in this unit.

Amended Tolerances

    1. PP 7E8616. (EPA-HQ-OPP-2017-0674). Interregional Research
Project No. 4 (IR-4), Rutgers, The State University of New Jersey, 500
College Road East, Suite 201W, Princeton, NJ 08540, proposes upon
establishment of tolerances referenced in this document under ``New
Tolerances'' for PP 7E8616, to remove existing tolerances in 40 CFR
180.658 for residues of the fungicide, penthiopyrad, (N-[2-(1,3-
dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-1H-pyrazole-4-
carboxamide) in or on the following raw agricultural commodities:
Brassica, head and stem, subgroup 5A at 5.0 ppm; Brassica, leafy
greens, subgroup 5B at 50 ppm; Canola at 1.5 ppm; Cotton, seed at 1.5
ppm; Fruit, stone, group 12 at 4.0 ppm; Nut, tree, group 14 at 0.06
ppm; Pistachio at 0.06 ppm; Sunflower, seed at 1.5 ppm and Vegetable,
leafy, except brassica, group 4 at 30 ppm. Contact: RD.
    2. PP 7E8629. (EPA-HQ-OPP-2017-0671). Interregional Research
Project No. 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State
University of NJ, 500 College Road East, Suite 201W, Princeton, NJ
08540, requests to amend 40 CFR 180.637 by removing the tolerances for
residues of mandipropamid: 4-chloro-N-[2-(3-methoxy-4-(2-
propynyloxy)phenyl]ethyl]-alpha-(2-propynyloxy)-benzeneacetamide in or
on the raw agricultural commodities Bean, snap at 0.90 ppm; Brassica,
head and stem, subgroup 5A at 3 ppm; Brassica, leafy greens, subgroup
5B at 25 ppm; Vegetable, leafy except Brassica, group 4 at 20 ppm.
Analytical method RAM 415-01 was developed for determination of
mandipropamid residues in crops. Contact: RD.
    3. PP 7E8644. (EPA-HQ-OPP-2018-0088). Interregional Research
Project No. 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State
University of NJ, 500 College Road East, Suite 201W, Princeton, NJ
08540, requests to amend 40 CFR 180.505 by removing the tolerances for
residues of emamectin benzoate, including its metabolites and
degradates, determined by measuring only the sum of emamectin (a
mixture of a minimum of 90% 4'-epi-methylamino-4'-deoxyavermectin B1a
and maximum of 10% 4'-epi-methylamino-4'-deoxyavermectin B1b) and its
metabolites 8,9-isomer of the B1a and B1b component of the parent (8,9-
ZMA), or 4'-deoxy-4'-epi-amino-avermectin B1a and 4'-deoxy-4'-epi-
amino-avermectin B1b; 4'-deoxy-4'-epi-amino avermectin B1a (AB1a); 4'-
deoxy-4'-epi-(N-formyl-N-methyl)amino-avermectin (MFB1a); and 4'-deoxy-
4'-epi-(N-formyl)amino-avermectin B1a (FAB1a), calculated as the
stoichiometric equivalent of emamectin in or on the raw agricultural
commodities Fruit, pome, group 11 at 0.025 parts per million, ppm, Nut,
tree, group 14 at 0.02 ppm, Pistachio at 0.02 ppm, Turnip, greens at
0.050 ppm, Vegetable, leafy, except brassica, group 4 at 0.100 ppm,
Vegetable, brassica, leafy, group 5 at 0.050 ppm, and Vegetable
fruiting, group 8 at 0.020 ppm. Adequate analytical methods (HPLC-
fluorescence methods) are

available for enforcement purposes. Contact: RD.
    4. PP 7E8648. (EPA-HQ-OPP-2018-0094). Interregional Research
Project No.4 (IR-4), Rutgers, The State University of New Jersey, 500
College Road East, Suite 201W, Princeton, NJ 08540, requests to amend
the tolerances in 40 CFR part 180.474 upon establishment of tolerances
referenced in this document under ``New Tolerances'' for PP 7E8648, by
removing established tolerances for residues of the fungicide
tebuconazole [[alpha]-[2-(4-chlorophenyl) ethyl]-[alpha]-(1,1-
dimethylethyl)-1H-1,2,4-triazole-1-ethanol], in or on the raw
agricultural commodities: Brassica, leafy greens, subgroup 5B at 2.5
parts per million, ppm; Cotton, undelinted seed at 2.0 ppm; Fruit,
pome, group 11 at 0.05 ppm; Fruit, stone, group 12, except cherry at
1.0 ppm; Grape at 5.0 ppm; Lychee at 1.6 ppm; Nut, tree, group 14 at
0.05 ppm; Peach at 1.0 ppm; Pistachio at 0.05 ppm; Plum, pre- and post-
harvest at 1.0 ppm; Sunflower, seed at 0.05 ppm. Contact: RD.
    5. PP 7E8652. (EPA-HQ-OPP-2018-0128). The Interregional Research
Project Number 4 (IR-4), Rutgers, The State University of New Jersey,
500 College Road East, Suite 201W, Princeton, NJ 08540, proposes upon
establishment of tolerances referenced in this document under ``New
Tolerances'' for PP 8E8652, to remove existing tolerances in 40 CFR
180.317 for residues of the herbicide pronamide (propyzamide), 3,5-
dichloro-N-(1,1-dimethyl-2-propynyl)benzamide in or on apple at 0.1
parts per million (ppm); blackberry at 0.05 ppm; blueberry at 0.05 ppm;
boysenberry at 0.05 ppm; fruit, stone, group 12 at 0.1 ppm; grape at
0.1 ppm; pear at 0.1 ppm; and raspberry at 0.05 ppm. Contact: RD.
    6. PP 7E8654. (EPA-HQ-OPP-2018-0161). Interregional Research
Project No. 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State
University of NJ, 500 College Road East, Suite 201W, Princeton, NJ
08540, requests to amend 40 CFR 180.511 by removing the established
tolerances for residues of buprofezin, 2-(1,1-
dimethylethyl)iminotetrahydro-3(1-methylethyl)-5-phenyl-4H-1,3,5-
thiadiazin-4-one in or on the raw agricultural commodities: Acerola at
0.30 parts per million (ppm); Brassica, head and stem, subgroup 5A at
12.0 ppm, Brassica, leafy greens, subgroup 5B at 60 ppm, Cotton,
undelinted seed at 0.35 ppm; Fruit, citrus, group 10 at 2.5 ppm; Fruit,
stone, group 12, except apricot and peach at 1.9 ppm; Grape at 2.5 ppm;
Longan at 0.30 ppm; Lychee at 0.30 ppm; Nut, tree group 14 at 0.05 ppm;
Olive at 3.5 ppm; Olive, oil at 4.8 ppm; Pistachio at 0.05 ppm; Spanish
lime at 0.30 ppm; Turnip, greens at 60 ppm; Vegetable, leafy, except
Brassica, group 4, except head lettuce and radicchio at 35 ppm; and Wax
jambu at 0.30 ppm. The enforcement analytical methods are available in
PAM I and PAM II for the enforcement of buprofezin tolerances, which
include gas chromatography methods with nitrogen phosphorus detection
(GC/NPD), and a gas chromatography/mass spectrometry (GC/MS) method for
confirmation of buprofezin residues in plant commodities. Contact: RD.
    7. PP 8E8658. (EPA-HQ-OPP-2018-0127). Interregional Research
Project No. 4 (IR-4), Rutgers, The State University of New Jersey, 500
College Road East, Suite 201W, Princeton, NJ 08540, proposes, upon
establishment of tolerances referenced in this document under ``New
Tolerances'' for PP 8E8758, the following: (i). To remove existing
tolerances in 40 CFR 180.613(a) for the residues of propiconazole,
including its metabolites and degradates, in or on the raw agricultural
commodities: Beet, garden, roots at 0.30 parts per million (ppm);
Brassica leafy greens, subgroup 5B at 20 ppm; Carrot, roots at 0.25
ppm; Leaf petioles subgroup 4B at 5.0 ppm; Pistachio at 0.1 ppm;
Radish, roots at 0.04 ppm; and Tomato at 3.0 ppm, and (ii). To amend 40
CFR 180.434(b) Section 18 emergency exemption: By removing the
established time-limited tolerance for residues of propiconazole and
its metabolites for Avocado at 10 ppm. Contact: RD.
    8. PP 8E8664. (EPA-HQ-OPP-2018-0143). Interregional Research
Project No. 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State
University of NJ, 500 College Road East, Suite 201W, Princeton, NJ
08540, requests to amend 40 CFR 180.449 by removing the established
tolerances for residues of abamectin, including its metabolites and
degradates, in or on the following commodities: Lychee at 0.01 parts
per million (ppm) and Vegetable, leafy, except brassica, group 4 at
0.10 ppm. The analytical methods involve homogenization, filtration,
partition, and cleanup with analysis by high performance liquid
chromatography (HPLC)-fluorescence detection. The methods are
sufficiently sensitive to detect residues at or above the tolerances
proposed. All methods have undergone independent laboratory validation.
Contact: RD.
    9. PP 8E86669. (EPA-HQ-OPP-2018-0179). Interregional Research
Project No. 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State
University of NJ, 500 College Road East, Suite 201W, Princeton, NJ
08540, requests to amend 40 CFR 180.668 by removing the established
tolerances for residues of Sulfoxaflor ((N-methyloxido1-6-
(trifluoromethyl)-3-pyridinyl]ethyl]-[gamma]4-sulfanylidene]cyanamide)
in or on the raw agricultural commodities: Fruit, stone, group 12 at
3.0 ppm, Leafy greens, subgroup 4A at 6.0 ppm, Leafy petiole, subgroup
4B at 2.0 ppm, Nuts, tree, group 14 at 0.015 ppm, Pistachio at 0.015
ppm and Vegetable, brassica, leafy, group 5, except cauliflower at 2.0
ppm. Analytical method 091116, ``Enforcement Method for the
Determination of Sulfoxaflor (XDE-208) and its Main Metabolites in
Agricultural Commodities using Offline Solid-Phase Extraction and
Liquid Chromatography with Tandem Mass Spectrometry Detection'' was
validated on a variety of plant matrices. Contact: RD.
    10. PP 8E8673. (EPA-HQ-OPP-2018-0286). Interregional Research
Project Number 4 (IR-4), Rutgers, The State University of New Jersey,
500 College Road East, Suite 201W, Princeton, NJ 08540, proposes upon
establishment of tolerances referenced in this document under ``New
Tolerances'' for PP 8E8673, to remove existing tolerances in 40 CFR
180.414 for residues of the insecticide cyromazine, (N-cyclopropyl-
1,3,5-triazine-2,4,6-triamine) in or on cabbage, abbyssinian at 10.0
parts per million (ppm); cabbage, seakale at 10.0 ppm, garlic at 0.2
ppm; garlic, great-headed, bulb at 0.2 ppm; hanover salad, leaves at
10.0 ppm; leek at 3.0 ppm; onion, bulb at 0.2 ppm; onion, green at 3.0
ppm; onion, potato at 3.0 ppm; onion, tree at 3.0 ppm; onion, welsh at
3.0 ppm; pepper at 1.0 ppm; potato at 0.8 ppm; rakkyo, bulb at 0.2 ppm;
shallot, bulb at 0.2 ppm; shallot, fresh leaves at 3.0 ppm; tomato at
0.5 ppm; turnip, greens at 10.0 ppm; vegetable, brassica, leafy, group
5, except broccoli at 10.0; vegetable, leafy, except brassica, group 4
at 7.0 ppm. The analytical methods AG-408 and AG-417 are used to
measure and evaluate the chemical cyromazine. Contact: RD

New Tolerance Exemptions for Inerts (Except PIPS)

    PP IN-11080. (EPA-HQ-OPP-2018-0202). OMC Ag Consulting, Inc., 828
Tanglewood Ln., East Lansing, MI 48823, on behalf of Nutri Ag Inc.,
4740 N Interstate 35 E., Waxahachie, TX 75165, requests to establish an
exemption from the requirement of a tolerance for residues of protein
hydrolyzates, animal (CAS Reg. No. 100085-61-8) when used as an inert
ingredient (carrier) in pesticide formulations applied to growing crops
and raw agricultural commodities under

40 CFR 180.910. The petitioner believes no analytical method is needed
because it is not required for an exemption from the requirement of a
tolerance. Contact: RD.

New Tolerance Exemptions for Non-Inerts (Except PIPS)

    PP 8F8670. (EPA-HQ-OPP-2018-0244). Monsanto Company, 800 N
Lindbergh Blvd., St. Louis, MO 63167, requests to establish an
exemption from the requirement of a tolerance in 40 CFR part 180 for
residues of the plant regulator LCO MOR116 (chemical name: D-glucose,
O-6-deoxy-2-O-methyl-[alpha]-L-galactopyranosyl-(1[rarr]6)-O-[O-2-
deoxy-2-[[(11Z)-1-oxo-11-octadecen-1-yl]amino]-[beta]-D-glucopyranosyl-
(1[rarr]4)-O-2-(acetylamino)-2-deoxy-[beta]-D-glucopyranosyl-
(1[rarr]4)-O-2-(acetylamino)-2-deoxy-[beta]-D-glucopyranosyl-
(1[rarr]4)-2-(acetylamino)-2-deoxy-[beta]-D-glucopyranosyl-(1[rarr]4)]-
2-(acetylamino)-2-deoxy-; and D-glucose, O-2-deoxy-2-[[(11Z)-1-oxo-11-
octadecen-1-yl]amino]-[beta]-D-glucopyranosyl-(1[rarr]4)-O-2-
(acetylamino)-2-deoxy-[beta]-D-glucopyranosyl-(1[rarr]4)-O-2-
(acetylamino)-2-deoxy-[beta]-D-glucopyranosyl-(1[rarr]4)-O-2-
(acetylamino)-2-deoxy-[beta]-D-glucopyranosyl-(1[rarr]4)-O-[6-deoxy-
[alpha]-L-galactopyranosyl-(1[rarr]6)]-2-(acetylamino)-2-deoxy-) in or
on all food commodities. The petitioner believes no analytical method
is needed because, even in the unlikely event that dietary exposure
does occur associated with the requested uses, the demonstrated
favorable toxicological profile for LCO MOR116 does not present a
potential for hazard to humans or the environment. Contact: BPPD

New Tolerances for Non-Inerts

    1. PP 7E8616. (EPA-HQ-OPP-2017-0674). Interregional Research
Project No. 4 (IR-4), Rutgers, The State University of New Jersey, 500
College Road East, Suite 201W, Princeton, NJ 08540, is proposing,
pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a
tolerance for residues of the fungicide penthiopyrad, (N-[2-(1,3-
dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-1H-pyrazole-4-
carboxamide) in or on the raw agricultural commodities: Brassica, leafy
greens, subgroup 4-16B at 50 parts per million (ppm); Bushberry
subgroup 13-07B at 6 ppm; Fruit, stone, group 12-12 at 4.0 ppm;
Caneberry subgroup 13-07A at 10 ppm; Celtuce at 30 ppm; Fennel,
Florence at 30 ppm; Kohlrabi at 5.0 ppm; Leaf petiole vegetable
subgroup 22B at 30 ppm; Leafy greens subgroup 4-16A at 30 ppm; Nut,
tree, group 14-12 at 0.06 ppm; Oilseed group 20 at 1.5 ppm; and
Vegetable, brassica, head and stem, group 5-16 at 5.0 ppm. An
analytical enforcement method, liquid chromatograph (LC) equipped with
a reverse phase column and a triple quadruple mass spectrometer (MS/MS)
detection is available for determining penthiopyrad residues in plants.
The limit of quantification (LOQ) is 0.01 ppm for most matrices except
for very dry matrices, e.g., pea hay, for which the LOQ is 0.05 ppm.
Contact: RD.
    2. PP 7E8629. (EPA-HQ-OPP-2017-0671). Interregional Research
Project No. 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State
University of NJ, 500 College Road East, Suite 201W, Princeton, NJ
08540, requests to establish a tolerance in 40 CFR part 180 for
residues of mandipropamid: 4-chloro-N-[2-(3-methoxy-4-(2-
propynyloxy)phenyl]ethyl]-alpha-(2-propynyloxy)-benzeneacetamide] in or
on the raw agricultural commodities Asparagus bean, edible podded at
0.90 ppm; Bean (Phaseolus spp.), edible podded at 0.90 ppm; Bean (Vigna
spp.), edible podded at 0.90 ppm; Brassica, leafy greens, subgroup 4-
16B at 25 ppm; Catjang bean, edible podded at 0.90 ppm; Celtuce at 20
ppm; Chinese longbean, edible podded at 0.90 ppm; Citrus, dried pulp at
0.14 ppm; Citrus, oil at 2.2 ppm; Cowpea, edible podded at 0.90 ppm;
Florence fennel at 20 ppm; French bean, edible podded 0.90 ppm; Fruit,
citrus, group 10-10 at 0.5 ppm; Garden bean, edible podded at 0.90 ppm;
Goa bean, edible podded at 0.90 ppm; Green bean, edible podded at 0.90
ppm; Guar bean, edible podded at 0.90 ppm; Jackbean, edible podded at
0.90 ppm; Kidney bean, edible podded at 0.90 ppm; Kohlrabi at 3 ppm;
Lablab bean, edible podded at 0.90 ppm; Leaf petiole vegetable subgroup
22B at 20 ppm; Leafy greens subgroup 4-16A at 25 ppm; Moth bean, edible
podded at 0.90 ppm; Mung bean, edible podded at 0.90 ppm; Navy bean,
edible podded at 0.90 ppm; Rice bean, edible podded at 0.90 ppm;
Scarlet runner bean, edible podded at 0.90 ppm; Snap bean, edible
podded at 0.90 ppm; Sword bean, edible podded at 0.90 ppm; Urd bean,
edible podded at 0.90 ppm; Vegetable soybean, edible podded at 0.90
ppm; Vegetable, brassica, head and stem, group 5-16 at 3 ppm; Velvet
bean, edible podded at 0.90 ppm; Wax bean, edible podded at 0.90 ppm;
Winged pea, edible podded at 0.90 ppm; Yardlong bean, edible podded at
0.90 ppm. Analytical method RAM 415-01 was developed for determination
of mandipropamid residues in crops. Contact: RD.
    3. PP 7F8642. EPA-HQ-OPP-2018-0143. Syngenta Crop Protection, LLC,
P.O. Box 18300, Greensboro, NC 27419-8300, requests to establish a
tolerance in 40 CFR part 180 for residues of the insecticide,
abamectin, in or on edible-podded legume vegetables subgroup 6a at 0.03
parts per million (ppm), succulent shelled pea and bean subgroup 6B at
0.005 ppm, and dried shelled pea and bean (except soybean) subgroup 6C
at 0.005 ppm. The high performance liquid chromatography (HPLC)
analytical method is used to measure and evaluate the chemical
abamectin. Contact: RD.
    4. PP 7E8644. (EPA-HQ-OPP-2018-0088). Interregional Research
Project No. 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State
University of NJ, 500 College Road East, Suite 201W, Princeton, NJ
08540, requests to establish a tolerance in 40 CFR part 180 for
residues of emamectin, including its metabolites and degradates,
determined by measuring only the sum of emamectin (a mixture of a
minimum of 90% 4'-epi-methylamino-4'-deoxyavermectin B1a and maximum of
10% 4'-epi-methylamino-4'-deoxyavermectin B1b) and its metabolites 8,9-
isomer of the B1a and B1b component of the parent (8,9-ZMA), or 4'-
deoxy-4'-epi-amino-avermectin B1a and 4'-deoxy-4'-epi-amino-avermectin
B1b; 4'-deoxy-4'-epi-amino avermectin B1a (AB1a); 4'-deoxy-4'-epi-(N-
formyl-N-methyl)amino-avermectin (MFB1a); and 4'-deoxy-4'-epi-(N-
formyl)amino-avermectin B1a (FAB1a), calculated as the stoichiometric
equivalent of emamectin in or on the raw agricultural commodities
Artichoke, globe at 0.06 parts per million (ppm), Brassica, leafy
greens, subgroup 4-16B at 0.050 ppm, Celtuce at 0.100 ppm, Cherry
subgroup 12-12A at 0.10 ppm, Fennel, Florence at 0.100 ppm, Fruit,
pome, group 11-10 at 0.025 ppm, Herb subgroup 19A at 0.50 ppm, Kohlrabi
at 0.050 ppm, Leafy greens subgroup 4-16A at 0.100 ppm, Leaf petiole
vegetable subgroup 22B at 0.100 ppm, Nut, tree, group 14-12 at 0.02
ppm, Vegetable, brassica, head and stem, group 5-16 at 0.050 ppm, and
Vegetable, fruiting, group 8-10 at 0.020 ppm. Adequate analytical
methods (HPLC-fluorescence methods) are available for enforcement
purposes. Contact: RD.
    5. PP 7E8645. (EPA-HQ-OPP-2018-0095). Interregional Research
Project No. 4 (IR-4), Rutgers, The State University of New Jersey, 500
College Road East, Suite 201W, Princeton, NJ 08540, requests to
establish a tolerance

in 40 CFR part 180 for residues of the herbicide/soil microbicide
nitrapyrin (2-chloro-6-(trichloromethyl) pyridine) and its metabolite,
6-chloropicolinic acid (6-CPA), calculated as the stoichiometric
equivalent of nitrapyrin, in or on the raw agricultural commodities:
Citrus, dried pulp at 0.094 parts per million (ppm), Citrus, oil at
0.37 ppm, Fruit, citrus, group 10-10 at 0.03 ppm, Leaf petiole
vegetable subgroup 22B at 0.4 ppm, Vegetable, brassica, head and stem,
group 5-16 at 0.07 ppm, Vegetable, bulb, group 3-07 at 0.3 ppm, and
Vegetable, leafy, group 4-16 at 0.3 ppm. Adequate residue analytical
methods are available for measuring and enforcing plant tolerances
including: Method 205G881A-1 determines residues of nitrapyrin by gas
chromatography with electron-impact mass spectrometry detection, and
Method 205G881-B1 determines residues of 6-chloropicolinic acid by
liquid chromatography with tandem mass spectrometry detection. Both
methods have been validated. Contact: RD.
    6. PP 7F8646. (EPA-HQ-OPP-2018-0053). BASF Corporation, 26 Davis
Dr., P.O. Box 13528, Research Triangle Park, NC 27709, requests to
establish a tolerance in 40 CFR part 180 for residues of the
insecticide, broflanilide, including its metabolites and degradates, in
or on grain, cereal, except rice, group 15; amaranth grain; quinoa,
grain; spelt, grain; canihua, grain; chia, grain; cram-cram, grain;
huauzontle, grain; teff, grain; corn, sweet, kernel plus cob with husks
removed at 0.01 parts per million (ppm) and commodity vegetables,
tuberous and corm, subgroup 1C at 0.04 ppm. Tolerances are also
requested for cattle, meat; goat, meat; horse, meat; sheep, meat at
0.01 ppm, and commodity milk, fat; poultry, fat at 0.02 ppm, and
commodity cattle, fat; sheep, fat; goat, fat at 0.05 ppm. Additionally,
tolerances are requested for grain, cereal, forage, fodder and straw,
group 16, except rice; quinoa, hay; teff, hay; corn, sweet, stover;
corn, sweet, forage at 0.01 ppm, and commodity corn, field, milled
products at 0.015 ppm and potato, wet peel at 0.1 ppm for processed
commodities. In addition, BASF is proposing to establish a tolerance of
0.01 ppm for residues of Broflanilide in or on all food items in food
handling establishments where food and food products are held,
processed, prepared and/or served. The independently validated
analytical method is used to measure and evaluate the chemical
Broflanilide and its metabolites S(PFP-OH)-8007 and DM-8007. An
independently validated analytical method has been submitted for
analyzing residues of parent Broflanilide plus metabolites DM-8007 and
DC-DM-8007 in animal matrices by Liquid chromatography with tandem mass
spectrometry (LC-MS/MS). Food handling matrices samples were analyzed
for Broflanilide residues using a combination of the plant and animal
methods with minor modifications. Contact: RD.
    7. PP 7E8648. (EPA-HQ-OPP-2018-0094). Interregional Research
Project No.4 (IR-4), Rutgers, The State University of New Jersey, 500
College Road East, Suite 201W, Princeton, NJ 08540, requests to
establish a tolerance in 40 CFR part 180 for residues of the fungicide
tebuconazole, including its metabolites and degradates. Compliance with
the tolerance levels specified is to be determined by measuring only
tebuconazole [[alpha]-[2-(4-chlorophenyl) ethyl]-[alpha]-(1,1-
dimethylethyl)-1H-1,2,4-triazole-1-ethanol], in or on the raw
agricultural commodities: Brassica, leafy greens, subgroup 4-16B,
except watercress at 2.5 parts per million (ppm); Cottonseed subgroup
20C at 2.0 ppm; Fruit, pome, group 11-10 at 1.0 ppm; Fruit, stone,
group 12-12, except cherry at 1.0 ppm; Fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13-07F at 6.0 ppm; Nut, tree, group
14-12 at 0.05 ppm; Sunflower subgroup 20B at 0.1 ppm, Tropical and
subtropical, small fruit, inedible peel, subgroup 24A at 1.6 ppm; and
Watercress at 9.0 ppm. Practical analytical methods for enforcement
purposes in detecting and measuring levels of tebuconazole and the
triazole metabolites: 1,2,4-triazole (T), traizole alanine (TA) and the
traizole acetic acid (TAA) have been developed and validated in/on all
appropriate agricultural commodities and respective processing
fractions. Contact: RD.
    8. PP 7F8651. (EPA-HQ-OPP-2018-0194). ISK Biosciences Corporation,
7470 Auburn Rd, Suite A, Concord, OH 44077, requests to establish a
tolerance in 40 CFR part 180 for residues of the insecticide
cylaniliprole on citrus fruit (crop group 10-10) at 0.5 ppm; tuberous &
corm vegetables (crop group 1C) at 0.01 ppm; and berry & small fruit
(crop subgroup 13-07A, 13-07B, 13-07E except grape, and 13-07G) at 1.5
ppm. Liquid chromatography-MS/MS is used to measure and evaluate the
chemical cyclaniliprole residues. Contact: RD
    9. PP 7E8652. (EPA-HQ-OPP-2018-0128). The Interregional Research
Project Number 4 (IR-4), Rutgers, The State University of New Jersey,
500 College Road East, Suite 201W, Princeton, NJ 08540, requests to
establish tolerances in 40 CFR part 180. 317 for residues of the
herbicide pronamide (propyzamide), 3,5-dichloro-N-(1,1-dimethyl-2-
propynyl)benzamide in or on berry, low growing, except strawberry,
subgroup 13-07H at 1 parts per million (ppm), bushberry subgroup 13-07B
at 0.05 ppm; caneberry subgroup 13-07A at 0.05 ppm; fruit, pome, group
11-10 at 0.1 ppm; fruit, small, vine climbing, except fuzzy kiwifruit,
subgroup 13-07F at 0.1 ppm; and fruit, stone, group 12-12 at 0.1 ppm.
The GLC/ECD method listed in the Pesticide Analytical Manual (PAM)
Volume II is used to measure and evaluate the chemical. Contact: RD.
    10. PP 7E8654. (EPA-HQ-OPP-2018-0161). Interregional Research
Project No. 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State
University of NJ, 500 College Road East, Suite 201W, Princeton, NJ
08540, requests to establish tolerances for residues of buprofezin, 2-
(1,1-dimethylethyl)iminotetrahydro-3(1-methylethyl)-5-phenyl-4H-1,3,5-
thiadiazin-4-one in or on the raw agricultural commodities Fig at 0.70
parts per million (ppm), Leafy greens subgroup 4-16A, except head
lettuce and radicchio at 35 ppm; Brassica, leafy greens, subgroup 4-16B
at 60 parts per million (ppm); Vegetable, brassica, head and stem,
group 5-16 at 12.0 ppm; Leaf petiole vegetable subgroup 22B at 35 ppm;
Celtuce at 35 ppm; Fennel, Florence at 35 ppm; Kohlrabi at 12.0 ppm;
Tropical and subtropical, small fruit, edible peel, subgroup 23A at 5.0
ppm; Tropical and subtropical, small fruit, inedible peel, subgroup 24A
at 0.30 ppm; Cottonseed subgroup 20C at 0.35 ppm; Fruit, citrus, group
10-10 at 2.5 ppm; Fruit, stone, group 12-12, except apricot and peach
at 2.0 ppm; Fruit, small, vine climbing, except fuzzy kiwifruit,
subgroup 13-07F at 2.5 ppm and Nut, tree, group 14-12 at 0.05 ppm. The
enforcement analytical methods are available in PAM I and PAM II for
the enforcement of buprofezin tolerances, which include gas
chromatography methods with nitrogen phosphorus detection (GC/NPD), and
a gas chromatography/mass spectrometry (GC/MS) method for confirmation
of buprofezin residues in plant commodities. Contact: RD.
    11. PP 8E8658. (EPA-HQ-OPP-2018-0127). Interregional Research
Project No. 4, (IR-4), Rutgers, The State University of New Jersey, 500
College Road East, Suite 201W, Princeton, NJ 08540 requests, pursuant
to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a(d), to amend 40 CFR part 180.434 (a) General by
establishing a tolerance for residues of propiconazole, including

its metabolites and degradates. Compliance with the tolerance levels
specified below is to be determined by measuring only those
propiconazole residues convertible to 2,4-dichlorobenzoic acid (2,4-
DCBA), expressed as the stoichiometric equivalent of propiconazole, in
or on the raw agricultural commodities: Avocado, at 0.2 parts per
million (ppm); Brassica, leafy greens, subgroup 4-16B, except
watercress at 20 ppm; Celtuce at 5.0 ppm; Florence fennel at 5.0 ppm;
Leaf petiole vegetable subgroup 22B at 5.0 ppm; Swiss chard at 5.0 ppm,
Tomato subgroup 8-10A at 3.0 ppm and Vegetable, root, except sugar
beet, subgroup 1B at 0.30 ppm. Analytical methods AG-626 and AG-454A
were developed for the determination of residues of propiconazole and
its metabolites containing the DCBA moiety. Analytical method AG-626
has been accepted and published by EPA as the tolerance enforcement
method for crops. The limit of quantitation (LOQ) for the method is
0.05 ppm. Contact: RD.
    12. PP 8E8660. (EPA-HQ-OPP-2018-0275). The Interregional Research
Project Number 4 (IR-4), Rutgers, The State University of New Jersey,
500 College Road East, Suite 201W, Princeton, NJ 08540, requests to
establish a tolerance in 40 CFR part 180. 446 for residues of the
insecticide clofentezine, 3,6-bis(2-chlorophenyl)-1,2,4,5-tetrazine in
or on guava at 1 part per million (ppm). The analytical method for
residues of clofentezine in fruit (Western Red Delicious Apples) by
high-performance liquid chromatography (HPLC) and ultra violet (UV)
Detection'' is used to measure and evaluate the chemical. Contact: RD.
    13. PP 8E8664. (EPA-HQ-OPP-2018-0143). Interregional Research
Project No. 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State
University of NJ, 500 College Road East, Suite 201 W, Princeton, NJ
08540, requests to establish tolerances for residues of abamectin,
including its metabolites and degradates, in or on the following
commodities. Compliance with the tolerance levels is to be determined
by measuring only avermectin B1 a mixture of avermectins containing
greater than or equal to 80% avermectin B1 a (5-O-demethyl avermectin
A1) and less than or equal to 20% avermectin B1b (5-O-demethyl-25-de(1-
methylpropyl)-25-(1-methylethyl) avermectin A1) and its delta-8,9-
isomer in or on the raw agricultural commodities: Arugula at 0.10 parts
per million (ppm), Carrot, roots at 0.03 ppm, Celtuce at 0.10 ppm,
Fennel, Florence at 0.10 ppm, Garden cress at 0.10 ppm, Leaf petiole
vegetable subgroup 22B at 0.10 ppm, Leafy greens subgroup 4-16A at 0.10
ppm, Tropical and subtropical, small fruit, inedible peel, subgroup 24A
at 0.01 ppm, and Upland cress at 0.10 ppm. The analytical methods
involve homogenization, filtration, partition, and cleanup with
analysis by high performance liquid chromatography (HPLC)-fluorescence
detection. The methods are sufficiently sensitive to detect residues at
or above the tolerances proposed. All methods have undergone
independent laboratory validation. Contact: RD.
    14. PP 8E8666. (EPA-HQ-OPP-2018-0179). Interregional Research
Project No. 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State
University of NJ, 500 College Road East, Suite 201 W, Princeton, NJ
08540, requests to establish tolerances for residues of sulfoxaflor
((N-methyloxido1-6-(trifluoromethyl)-3-pyridinyl]ethyl]-[gamma]4-
sulfanylidene]cyanamide) in or on the raw agricultural commodities:
Artichoke, globe at 0.70 parts per million (ppm), Asparagus at 0.015
ppm, Brassica, leafy greens, subgroup 4-16B, except watercress at 2.0
ppm, Bushberry subgroup 13-07B at 2.0 ppm, Caneberry subgroup 13-07A at
1.5 ppm, Celtuce at 2.0 ppm, Florence fennel at 2.0 ppm, Fruit, stone,
group 12-12 at 3.0 ppm, Kohlrabi at 2.0 ppm, Leafy greens subgroup 4-
16A at 6.0 ppm, Leaf petiole vegetable subgroup 22B at 2.0 ppm, Nut,
tree, group 14-12 at 0.015 ppm, Sunflower subgroup 20B at 0.30 ppm, and
Vegetable, brassica, head and stem, group 5-16, except cauliflower at
2.0 ppm. Analytical method 091116, ``Enforcement Method for the
Determination of Sulfoxaflor (XDE-208) and its Main Metabolites in
Agricultural Commodities using Offline Solid-Phase Extraction and
Liquid Chromatography with Tandem Mass Spectrometry Detection'' was
validated on a variety of plant matrices. Contact: RD.
    15. PP 8E8667. (EPA-HQ-OPP-2018-0273). Interregional Research
Project No.4 (IR-4), Rutgers, The State University of New Jersey, 500
College Road East, Suite 201W, Princeton, NJ 08540, requests to
establish a tolerance in 40 CFR part 180 for residues of the
insecticide flonicamid, including its metabolites and degradates,
determined by measuring only the sum of flonicamid, N-(cyanomethyl)-4-
(trifluoromethyl)-3-pyridinecarboxamide, and its metabolites, TFNA (4-
trifluoromethylnicotinic acid), TFNA-AM (4-
trifluoromethylnicotinamide), and TFNG, N-(4-
trifluoromethylnicotinoyl)glycine, calculated as the stoichiometric
equivalent of flonicamid, in or on raw agricultural commodities as
follows: Sunflower subgroup 20B at 0.70 parts per million (ppm).
Analytical methodology to determine above designated residues of
flonicamid for the majority of crops includes an initial extraction
with acetonitrile (ACN)/deionized (DI) water, followed by a liquid-
liquid partition with ethyl acetate. The final sample solution is
quantitated using a liquid chromatograph (LC) equipped with a reverse
phase column and a triple quadruple mass spectrometer (MS/MS). Contact:
RD.
    16. PP 8E8673. (EPA-HQ-OPP-2018-0286). Interregional Research
Project Number 4 (IR-4), Rutgers, The State University of New Jersey,
500 College Road East, Suite 201W, Princeton, NJ 08540, requests to
establish a tolerance in 40 CFR part 180. 414 for residues of the
insecticide cyromazine, (N-cyclopropyl-1,3,5-triazine-2,4,6-triamine)
in or on Brassica, leafy greens, subgroup 4-16B at 10.0 parts per
million (ppm); Celtuce at 7.0 ppm; Chickpea, edible podded at 0.4 ppm;
Chickpea, succulent shelled at 0.3 ppm; Dwarf pea, edible podded at 0.4
ppm; Edible podded pea, edible podded at 0.4 ppm; English pea,
succulent shelled at 0.3 ppm; Florence fennel at 7.0 ppm; Garden pea,
succulent shelled at 0.3 ppm; Grass-pea, edible podded at 0.4 ppm;
Green pea, edible podded at 0.4 ppm; Green pea, succulent shelled at
0.3 ppm; Kohlrabi at 10.0 ppm; Leaf petiole subgroup 22B at 7.0 ppm;
Leafy green subgroup 4-16A at 7.0 ppm; Lentil, edible podded at 0.4
ppm; Lentil, succulent shelled at 0.3 ppm; Onion, bulb, subgroup 3-07A
at 0.2 ppm; Onion, green, subgroup 3-07B at 3.0 ppm; Pepper/eggplant 8-
10B at 1.0 ppm; Pigeon pea, edible podded at 0.4 ppm; Pigeon pea,
succulent shelled at 0.3 ppm; Snap pea, edible podded at 0.4 ppm; Snow
pea, edible podded at 0.4 ppm; Sugar snap pea, edible podded at 0.4
ppm; Tomato subgroup 8-10A at 1.0 ppm; Vegetable, brassica, head and
stem, group 5-16, except broccoli at 10.0 ppm; and Vegetable, tuberous
and corm, subgroup 1C at 0.8 ppm. The analytical methods AG-408 and AG-
417 are used to measure and evaluate the chemical cyromazine. Contact:
RD.
    17. PP 8E8678. EPA-HQ-OPP-2018-0300. Dow AgroSciences, 9330
Zionsville Road, Indianapolis, IN 46268, requests to establish import
tolerance in 40 CFR part 180 for residues of the fungicide
fenbuconazole (alpha-(2-(4-chlorophenyl)ethyl]-alpha-phenyl-3-(1H-
1,2,4-triazole)-1-propanenitrile) and its metabolites cis and trans-5-
(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-

1,2,4-triazole-1-ylmethyl)-2-3H-furanone) in or on the raw agricultural
commodities tea, dried at 10 parts per million (ppm); and tea, instant
at 10 ppm. The analytical methodology column chromatography and
nitrogen -phosphorus detection (NPD) gas chromatography detection is
used to measure and evaluate the chemical fenbuconazole. Contact: RD.
    18. PP 8F8661. EPA-HQ-OPP-2018-0297. Cheminova A/S, P.O. Box 9, DK-
7620, Lemvig, Denmark and on behalf of FMC Corporation, 2929 Walnut
Street, Philadelphia, PA 19104, requests to establish tolerance in 40
CFR part 180 for residues of the fungicide flutriafol [chemical name
()[hyphen][alpha][hyphen](2[hyphen]fluorophenyl[hyphen][alpha][hyph
en](4[hyphen]fluorophenyl)[hyphen]1H[hyphen]1,2,4[hyphen]triazole[hyphen
]1[hyphen]ethanol] in or on the raw agricultural commodities alfalfa,
forage at 15 parts per million (ppm); alfalfa, hay at 50 ppm; barley,
grain at 1.5 ppm; barley, hay at 7.0 ppm; barley, straw at 8.0 ppm;
corn, sweet, forage at 9.0 ppm; corn, sweet, kernels plus cobs with
husks removed at 0.03 ppm; corn, sweet, stover at 8 ppm; rice, bran at
0.4 ppm; rice, grain at 0.5 ppm; rice, hulls at 1.5 ppm; and rice,
straw at 0.9 ppm. The analytical methodology gas chromatography (GC)
employing mass selective (MSD) detection and or HPLC/UPLC employing
tandem mass spectrometric (MS/MS) detection is used to measure and
evaluate the chemical flutriafol. Contact: RD.

    Authority:  21 U.S.C. 346a.

    Dated: July 10, 2018.
Hamaad Syed,
Acting Director, Information Technology and Resources Management
Division, Office of Pesticide Programs.
[FR Doc. 2018-15722 Filed 7-23-18; 8:45 am]
 BILLING CODE 6560-50-P