	DATA EVALUATION RECORD
	MYSID LIFE CYCLE TEST
	OCSPP 850.1350

1.  CHEMICAL:  	DCPA						PC Code No.: 078701

2.  TEST MATERIAL:  Dacthal Technical			Purity:    98.3%

3.  CITATION
	Authors:	Claude MB, Martin KH, Gallagher SP, and HO Krueger.
	Title:	Dacthal: A flow-through life-cycle toxicity test with the saltwater mysid (Americamysis bahia).
	Study Completion Date:	January 15, 2014
	Laboratory:	Wildlife International (Evans Analytical Group), Easton,
		Maryland, USA
	Sponsor:	Amvac Chemical Corporation, Los Angeles, California, USA
	Laboratory Report ID:	246A-116A
	MRID No.:	49307512
	DP Barcode:	420871

4.  REVIEWED BY:  Moncie V. Wright, Staff Scientist, CDM Smith/CSS-Dynamac JV
     Signature: 	Date:  10-11-2016

     APPROVED BY:  John Marton, Ph.D., Staff Scientist, CDM Smith/CSS-Dynamac JV

     Signature:	Date: 11/4/2016

5.  APPROVED BY:  Christina M. Wendel, Biologist, OPP/EFED/ERB2

     Signature:	Date: 12/01/2021

		Michael Wagman, Senior Scientist, OPP/EFED/ERB2

     Signature:	Date: 11/30/2021

This Data Evaluation Record may have been altered by the Environmental Fate and Effects Division subsequent to signing by CDM/CSS-Dynamac JV personnel.

6.  STUDY PARAMETERS

     	Scientific Name of Test Organism:	Americamysis bahia
     	Age of Test Organism:	Juveniles, <24-h post release from brood sac
     	Definitive Test Duration:	28 days (1[st] generation) and 96 hours (2[nd] generation)
     	Study Method:	Flow-through
     	Type of Concentrations:	Mean-measured

7.  CONCLUSIONS:

     Results Synopsis
     NOAEC:  <10 ug a.i./L
     LOAEC:  10 ug a.i./L

   	Endpoint(s) Affected: All reproductive and growth endpoints (e.g., F0 Male dry weight 			and length; Offspring/female; Time to first brood; F0 Female dry weight and length)
		Most sensitive endpoint:  F0 Male dry weight and length

8.  ADEQUACY OF THE STUDY

A.  Classification: This study is scientifically sound and is classified as supplemental and may 						be used for risk characterization.

     B.  Rationale: A definitive NOAEC could not be established in the study as dose-responsive effects on male weight and length were observed at all doses. Additionally, although no significant differences were observed between the solvent and negative controls, there was a potential slight negative interaction with the solvent and the test substance for the F0 male dry weight endpoint (13% ; p = 0.07) as well as a statistically significant difference between controls in the number of offspring per surviving female endpoint (-159% ; p= 0.04), resulting in uncertainties as to whether the solvent had an impact on the effects. Only a tabulation of the total live young produced was provided, a count of the total number young produced per day comparing the number of dead versus live young produced was not provided, although one could be estimated based on the information provided by the reviewer (Appendix II). Given the drastic difference in young produced and live young available for the G2 phase of the experiment this information is especially important. The study authors provided no rationale; however it can be postulated that the difference was attributed to potential cannibalism (either from G1 mysids or G2 cohorts), which is a possibility; however, given the great number difference, that may not be the only reason.

     C.  Repairability:  A NOAEC could not be determined in the study, as dose-responsive effects on male weight and length were observed at all doses. Additional data that includes lower concentrations is needed to reach a definitive NOAEC value. It is also recommended that any new test consider using a different solvent, as there may be an interaction between the test substance and the solvent.
9.  GUIDELINE DEVIATIONS:  This study was conducted according to a protocol based on procedures outlined in the U.S. Environmental Protection Agency Series 850  -  Ecological Effects Test Guidelines, OCSPP (formerly OPPTS) Number 850.1350: Mysid Chronic Toxicity Test and ASTM Standard E 1191-03a: Standard Guide for Conducting Life-Cycle Toxicity Tests with Saltwater Mysids.  The reviewer assessed the study methods and results according to the updated U.S. EPA OCSPP (form. OPPTS) Guideline 850.1350: Mysid Chronic Toxicity Test.  The following deviations and/or deficiencies from OCSPP 850.1350 were noted.
 The study authors did not report if they randomly assigned treatments to test chamber locations.
 An exploratory range-finding test was completed, and the concentrations were selected in consultation with the Sponsor and were based on exploratory range-finding toxicity data. However the results were not presented nor discussed within the study report.
 The total organic carbon (TOC) content of the well water used to dilute the sea water was not reported.  However, the lack of this information is considered to be a minor deficiency as the Kow and solubility of DCPA, (4.3 and 0.5 mg/L, respectively), in water would likely not result in an underestimation of toxicity.
 A definitive NOAEC was not established in the study. This is considered a major deficiency of the study for assessing chronic risk to estuarine/marine invertebrates.
  All live young produced were tabulated for each replicate and treatment level, and live young were kept for observation. However, the total of dead young vs. live young that were initially observed, was never quantified by the study author and so it is not clear how many were actually lost to cannibalism by the G1 parents or G2 cohorts or if they may have actually been lost due to treatment. Regardless, only a few LIVE G2 mysids were collected or available for the 96 hour test for further observations (Appendix 17 vs Appendix 20 of the study report, respectively), and no live G2 mysids were collected for the highest test concentration, although two young were produced (indicating they died before the G2 phase began) (G2 175 ug a.i./L level; the 157 ug a.i./L G1 level, respectively). However based on the information that was provided in the Appendices from the study report the total number of dead F1 young in the negative and solvent controls and treatment groups was estimated by the reviewer (Appendix II).
  There was a statistically significant difference between the number of offspring produced in the solvent control compared to the negative control (159%, p=0.04).  According to OCSPP 850.1000 guideline, solvents controls should not confound test results or affect test organisms at the concentration used.  Whether the improved performance observed in the solvent control for the number of offspring endpoint is a true difference caused by the solvent or more reflective of the high variability of this endpoint is not known, but this response would be considered unusual.

     These deficiencies did have an impact on the acceptability and scientific integrity of this study. The lack of a definitive NOAEC prevents the ability to use this study to quantitatively evaluate chronic risk to estuarine/marine invertebrates.

10.  MATERIALS AND METHODS:

     A.  Biological System
                              Guideline Criteria
                             Reported Information
Species:
An estuarine shrimp species, preferably Americamysis bahia.
Test species is the saltwater mysid (Americamysis bahia).
Duration of the Test:
A mysid test must not be terminated before 7 days past the median time of 1[st] brood release in the control treatment.
1[st] generation mysids (G1, F0): 28 days [which was at least 7 days past the median time of the first brood release for the G1 negative and solvent controls (Day 17)].
2[nd] generation mysids (G2, F1): 96 hours following the release of the mysids from the brood pouch
Source (or supplier)
In-house cultures maintained by the testing laboratory (Wildlife International).
Parental Acclimation
1) Parental stock must be maintained separately from the brood culture in dilution water and under test conditions.
2) Mysids should be in good health.
1.) Adult mysids were held in the laboratory >= 14 days before juveniles (<24 hours old) were collected for testing.  The culture was maintained in a re-circulating (flow-through) saltwater system using water from the same source as used during the test. During the 2-week period immediately preceding the test, water temperatures in the cultures were 25.5 to 26.0ºC, pH ranged from 8.2 to 8.6, salinity ranged from 20 to 21 ppt (%.), and DO concentrations were >=6.7 mg/L (>=91% of saturation).
2.) The pre-test health of the mysids was not reported.
Parental Acclimation Period
At least 14 days
At least 14 days.
Chamber Location:
Treatments should be randomly assigned to test chamber locations.
Organisms were impartially distributed to the test compartments. The delivery system and test chambers were placed in a temperature-controlled environmental chamber. Prior to pairing, mysids in each treatment and control group were held in one test compartment placed in each of four replicate test chambers. After mysids attained sexual maturity and were paired on Day 14, reproductive pairs were placed in reproductive compartments, one pair per compartment, with up to five compartments in each replicate test chamber. The G2 mysids were initiated in a separate test system using the same test apparatus as described above and with the same test chambers and compartments as used for the Gl mysids after sexual maturity.
Treatment vessel assignments with respect to location to each other were not reported.
Brood Stock:
Test started with mysids:
 1) from only one brood stock or
 2) from brood stock which has not obtained sexual maturity or had been maintained for > 14 days in a laboratory with same food, water, temperature, and salinity used in the test.
The test was started with mysids that had been maintained for >14 days with similar food, water, temperature, and salinity used in the tests.
Distribution:
No. of mysids before pairing: Minimum of 15 mysids per compartment, 2 compartments per chamber, 2 chambers per concentration for a total of 60/treatment level.
No. of mysids after pairing:
> 20 randomly selected pairs/treatment (excess males should be held in separate compartment in same treatment to replace paired males).
Before pairing: 60/level; 15 mysids per compartment, one compartment per replicate test chamber (4 replicates) for a total of 60 mysids per control and treatment group.

After pairing:  when possible, 20 pairs per level; one pair was placed in each compartment, with up to 5 compartments in each replicate chamber, resulting in 20 randomly selected pairs per control and treatment group (an additional compartment was maintained, if necessary, to house any remaining males).
Pairing:
1) Should be conducted when most of the mysids are sexually mature (usu. 10-14 days after test initiation).
2) Should be paired on the same day
After mysids (parental; G1 generation) attained sexual maturity they were paired on Day 14. At pairing, the sex and maturity of each G1 mysid was determined by microscopic examination, when possible five male/female pairs were assigned to reproductive compartments in each replicate test chamber, with one pair per compartment. Any immature G1 mysids or extra G1 females were discarded; sexually immature G1 males were maintained until G1 test termination.
Feeding:
1) Mysids should be fed live brine shrimp nauplii at least once daily.
2) 150 live brine shrimp nauplii per mysid per day or 75 twice a day is recommended.
Mysids in cultures were fed live brine shrimp nauplii (Artemia sp.) daily supplied by INVE Aquaculture, Salt Lake City, Utah. The brine shrimp periodically were enriched with a nutrient enrichment (A1 DHA Selco, INVE Thailand, Ltd., Thailand). During the test mysids were fed live brine shrimp nauplii (Artemia sp.) up to four times daily, with one feeding per day consisting of brine shrimp enriched with a nutrient formula. Food was periodically supplemented with the saltwater algae Skeletonema costatum (in-house Wildlife International cultures). Excess food and waste were siphoned out daily during observations.
Counts:
Live adult mysids should be counted
1) at initiation,
2) at pairing,
3) and daily after pairing.
4) Live young must be counted and removed daily.
5) Missing or impinged animals should be recorded.
G1 mysids (1[st] generation, F0) were counted daily throughout the test.
Live young (G2 mysids) produced by G1 mysids were counted, recorded, and removed daily after pairing. They were pooled and placed in a test compartment with up to 10 mysids per compartment. This G2 test chamber contained the same nominal test substance as the G1 chamber from where they originated. There was no minimum amount of G2 mysids to be initiated in the G2 phase each day. When available observations on mortality, abnormal development, and behavior were recorded for G2 mysids for approximately 96 hours.
Controls:
Negative control and carrier control (when applicable) are required.
Negative (dilution water only) and solvent (HPLC DMF, 0.1 mL/L) control.

Comments: The criteria for death included lack of movement, absence of respiratory movements, and lack of reaction to gentle prodding. At paring on Day 14, microscopic examination was used, and any immature G1 mysids or extra G1 females were discarded. Following pairing, excess mature male organisms were maintained in a separate compartment within the replicate. If a G1 male died in a reproductive compartment, it was replaced with another male, if available, from the pool of males maintained in the same replicate. All live young produced were tabulated for each replicate and treatment level, and live young were kept for observation. However, the total of dead young vs. live young that were initially observed, was not quantified by the study author and so it is not clear how many were lost to cannibalism by the G1 parents or G2 cohorts or if they may have actually been lost due to treatment. Regardless, only a few Live G2 mysids were collected or available for the 96 hour test for further observations (Appendix 17 vs Appendix 20 in the study report, respectively), no live G2 mysids were collected for the highest test concentration, although two young were produced (indicating they died before the G2 phase began) (G2 175 ug a.i./L level; the 157 ug a.i./L G1 level, respectively). However based on the information that was provided in the Appendices from the study report the total number of dead F1 young in the negative and solvent controls and treatment groups was estimated by the reviewer (Appendix II).

The in-life phase of the definitive test was conducted from August 28, 2013 to September 29, 2013.

	B.  Physical System:
                              Guideline Criteria
                             Reported Information
Test Water:
1) May be natural (sterilized and filtered) or a commercial mixture;
2) Water must be free of pollutants.
3) During the test, difference between highest and lowest measured salinities must be less than 10%. (parts per thousand). Should be measured daily.
4) Salinity should be between 15 and 30 .
5) pH should be measured at the beginning, end of test and weekly.
6) DO must be measured @ each conc. @ least once a wk.
7) See details in ASTM E-1191.
1.) Natural seawater collected at Indian River Inlet, Delaware. The water was ozonated, filtered to remove particles >25-micron, diluted to a salinity of 20 ppt (%.) with onsite well water, then aerated with spray nozzles. Prior to use, the water was filtered to 0.45-micron to remove fine particles and subsequently passed through a UV sterilizer.
The total organic carbon (TOC) content of the well water used to dilute the sea water was not reported.
2.) Pesticides, organics, and metals were not detected in the dilution water, except for barium, calcium, chloride, magnesium, potassium, sodium, and sulfate (Appendix 4 in study report; pg. 66-67).
3.) The difference between the highest and lowest values was <10 ppt (%.).
4.) Salinity ranged from 19 to 21 ppt in the G1 28-day exposure and from 20 to 21 ppt (%.) in the G2 96-hour exposure.
G1 (1[st] generation, F0) exposure: Salinity was measured daily in one replicate of the negative control, with measurements rotating among replicates at each measurement interval.
G2 (2[nd] generation, F1) exposure: Salinity was measured in each negative control replicate as it was initiated with mysids. Thereafter, it was measured daily in one replicate test chamber of the negative control during the test period and at test termination.
5.) G1 (1[st] generation, F0) exposure: The pH was measured in one replicate test chamber of each control and treatment group at test initiation and termination, and weekly during the test with measurements rotating among replicates at each measurement interval.
G2 (2[nd] generation, F1) exposure: The pH was measured in each control and treatment group as it was initiated with mysids. Thereafter, it was measured in one replicate test chamber of each control and treatment group weekly and at test termination, with measurements rotating among replicates.
6.) G1 (1[st] generation, F0) exposure: Prior to pairing, the DO was measured in one replicate test chamber from each control and treatment group at test initiation and weekly during the test period, with measurements typically rotating among the replicates in each group at each measurement interval. After pairing, DO was measured daily until test termination one replicate test chamber of each control and treatment group, with measurements rotating among the replicates in each group.
G2 (2[nd] generation, F1) exposure: DO was measured in each control and treatment group replicate as it was initiated with mysids. Thereafter, it was measured daily in one replicate chamber of each control and treatment group and at test termination, with measurements rotating among replicates.
The DO in the G1 test ranged from 5.5 to 7.4 mg/L, and in the G2 test ranged from 5.7 to 7.4 mg/L. A DO concentration of 4.4 mg/L represents 60% saturation at 25ºC in saltwater with a salinity of 20%..
Test Temperature:
1) Measured daily in one chamber and at least 3 times in all chambers.
2) Mean measured temperature for each chamber at test termination should be within 1C of selected test temperature.
3) Each individual measured temperature must be within 3°C of the mean of the time-weighted averages.
4) For mysid shrimp, 27°C is recommended.
5) Whenever temp. is measured concurrently in more than one test chamber the highest & lowest temp. must not differ by more than 2°C.
1.) G1 (1[st] generation, F0) exposure: The temperature was measured in each test chamber at test initiation and termination, and weekly during the test.
G2 (2[nd] generation, F1) exposure: The temperature was measured in a test chamber at test initiation and termination.
Temperature was monitored continuously in one negative control test chamber in both the G1 and G2 exposures.
2.) The mean-measured temperatures for each chamber at test termination were within 1ºC of the selected temperature of 25ºC.
4.) The test temperatures in the G1 test ranged from 24.7 to 26.2ºC, and in the G2 test ranged from 24.1 to 25.8ºC.
Photoperiod: Recommend 16L/8D.  14L/10D also acceptable.
Ambient laboratory light consisted of fluorescent light bulbs that emit wavelengths similar to natural sunlight and provided a photoperiod of 14L:10D, with a 120-minute transition period of low light intensity provided when lights went on and off. Light intensity was measured over the surface of one representative test chamber at test initiation in both G1 and G2 exposures, and measured 257 and 115 lux, respectively.
Dosing Apparatus:
1) Intermittent flow proportional diluters or continuous flow serial diluters should be used.
2) A minimum of 5 toxicant concentrations
3) A dilution factor not greater than 0.5 and controls should be used.
Continuous-flow diluter equipped with syringe pumps (Harvard Apparatus, South Natick, Massachusetts) that delivered stock solutions or solvent to mixing chambers where the stock or solvent were mixed with dilution water prior to delivery to the test chambers.
Toxicant Mixing:
1) Mixing chamber is recommended but not required;
2) Aeration should not be used for mixing;
3) It must be demonstrated that the test solution is completely mixed before intro. into the test system;
4) Flow splitting accuracy must be within 10%.
Mixing chambers were used. Rotameters controlled the flow of dilution water into each mixing chamber. After mixing, the flow from each mixing chamber was split to deliver the test water to the four replicate chambers.
Flow splitting accuracy varied by no more than +-10% of the mean flow rate for the four replicates.
Test Vessels:
1) Material: all glass, No. 316 stainless steel, or perflorocarbon plastic
  Test Chambers:
1) Most common: 300x450x150 mm deep with solution depth of 100 mm.
2) Should be covered.
  Test Compartments (within chambers):
1) Size: 250 ml beaker with side cutouts covered with nylon mesh or stainless steel screen.
or
2) 90 or 140 mm inside dia. glass Petri dish bottoms with collars made of 200 - 250 um mesh screen.
Prior to pairing:
Test compartments: 2-L glass containers measuring 12-cm in diameter and 19-cm in height, with two nylon mesh covered holes on opposite sides of the container (6.7-cm).
Test vessels/chambers: 9-L glass aquaria, containing ~2.5-L of test solution (depth 6.9-cm).
After pairing on Day 14:
Test vessels/chambers: 19-L glass aquaria, containing ~14.5-L of test solution (G1 exposure: depth 17.7-cm; G2 exposure: depth 18.5-cm).
Reproductive compartments: 10-cm diameter glass petri dishes with sides constructed of nylon mesh screen (G1 exposure: depth 17.4-cm; G2 exposure: depth 17.5-cm).
Flow Rate:
1) Flow rates should provide 5 to 10 volume additions per 24 hr.
2) Flow rate must maintain DO at or above 60% of saturation and maintain the toxicant level.
3) Meter systems calibrated before study and checked twice daily during test period.
1.) Prior to pairing, the appropriate amount of the five test substance stock solutions were injected into the diluter mixing chambers assigned to treatment groups at a rate of 12.5 uL/min where they were mixed with dilution water delivered at a rate of 125 mL/min to achieve the desired test concentrations. Following pairing, the stock solutions were injected into the diluter mixing chambers assigned to treatment groups at a rate of 25.0 uL/min where they were mixed where they were mixed with dilution water delivered at a rate of 250 mL/min to achieve the desired test concentrations. The flow of dilution water into each mixing chamber was controlled using rotameters and adjusted to provide each adult and juvenile test chamber with at least 6 and 18 volume additions of test water per day, respectively.
2.) DO was maintained at >=75% of saturation (5.5 mg/L) in both the G1 and G2 exposures.
3.) The rotameters used to control the flow of the dilution water to the mixing chambers were calibrated prior to the test and verified or recalibrated weekly during the test. Delivery of test solutions to the test chambers was initiated 6-days prior to the introduction of the mysids to the water. The operation of the exposure system was checked visually at least once on the first and last days of the test, and at least twice per day during the test.
Aeration:
1) Dilution water should be aerated to insure DO concentration at or near 100% saturation.
2) Test tanks may be aerated.
1.) The dilution water was aerated prior to use in the test.
2.) The test tanks were not aerated.

Comments: Results of periodic analysis of the dilution water for pesticides, organics, and metals were provided from water collected on December 26, 2012 (non-GLP), ca. 6 months prior to the definitive experiment. These results indicated that none of these compounds were detected at concentrations that are considered toxic in any of the water samples analyzed. A dissolved oxygen concentration of 4.4 mg/L represents 60% saturation at 25ºC in saltwater with a salinity of 20%.. The DO concentrations remained >=75% saturation (5.5mg/L) at 25ºC in saltwater with a salinity of 20%. for both G1 and G2 exposures.

Delivery of the test solutions into the test chambers was initiated 6 days prior to test initiation in order to achieve equilibrium of the test substance.  Delivery system and test chambers were placed in a temperature-controlled environmental chamber to maintain the target temperature throughout the test period.

     C.  Chemical System:
                              Guideline Criteria
                             Reported Information
Concentrations:
1) Minimum of 5 concentrations and a control, all replicated, plus solvent control if appropriate.
2) Toxicant conc. must be measured in one tank at each treatment level every week.
3) One concentration must adversely affect a life stage and one concentration must not affect any life stage.
4) The measured conc. of the test material of any treatment should be at least 50% of the time-weighted average measured conc. for >10% of the duration of the test.
5) The measured conc. for any treatment level should not be more than 30% higher than the time-weighted average measured conc. for more than 5% of the duration of the test.
1.) There were 5 nominal test concentrations (13, 25, 50, 100, 200 ug a.i./L), and a negative and solvent control.
2.) G1 (1[st] generation, F0) exposure: Analytical verification was performed on samples collected on days -1, 0, 7, 14, 15, 16, 21, and 28. Samples were collected mid-depth and processed immediately for analysis.
Mean-measured G1: <7.5 (<LOD, negative and solvent controls), 10, 21, 39, 76, and 157 ug a.i./L)
G2 (2[nd] generation, F1) exposure: Analytical verification was performed on samples collected on days -1, 0, 6, 13, and 15.
Mean-measured G2: <7.5 (<LOD, negative and solvent controls), 12, 24, 45, 84, and 175 ug a.i./L). Samples were collected mid-depth and processed immediately for analysis. Refer to copy of Excel worksheet in Appendix III.

Measured concentrations of Dacthal (DCPA) in G1 the samples ranged from approximately 61.2 to 101% of nominal. Measured concentrations of Dacthal (DCPA) in G2 the samples ranged from approximately 80.2 to 97.5% of nominal.
Solvents:
1) Should not exceed 0.1 ml/L in a flow-through system.
2) Following solvents are acceptable: triethylene glycol, methanol, acetone, ethanol.
HPLC-grade dimethylformamide (DMF) was used at a concentration of 0.1 mL/L (0.01%).
Comments:  Nominal concentrations were selected in consultation with the Sponsor.  No preliminary range-finding data were reported.

The test solutions in the mixing chambers and test chambers appeared clear and colorless during the test, with no evidence of precipitation observed in any control or treatment solution.

The analysis of Dacthal (DCPA) in saltwater was based on methodology developed by Wildlife International. The analytical method consisted of diluting the samples with saltwater, as necessary, and analyzed using HPLC with ultraviolet (UV) absorbance detection at 220 nm. The limit of quantitation (LOQ) for the analysis of Dacthal in saltwater was 7.50 ug a.i./L.

11.  REPORTED RESULTS:

                              Guideline Criteria
                             Reported Information
Quality assurance and GLP compliance statements were included in the report?
Yes. This study was conducted in compliance with the Good Laboratory Practice Standards as published by the U.S. EPA (40 CFR Parts 160 and 792), as well as the Japan and OECD Principles of GLP.
Controls:
1) Survival of the first-generation controls (between pairing and test termination) must not be less than 70%.
2) At least 75% of the paired 1[st] generation females in the controls produced young or
3) The average number of young produced by the 1[st] generation females in the control(s) was at least 3.
1.) Survival after pairing:
Negative control: 81%; Solvent control: 86%

2.) 90 and 94% of surviving females in the negative and solvent control, respectively, produced young.

3) The average number of young produced by the 1[st] generation females was 5.2 in the negative control and 13.5 in the solvent control.
Data Endpoints must include:
1) Survival of first-generation mysids
   Female
   Male
2) Number of live young produced per female
3) Dry weight of each first-generation mysid alive at the end of the test
   Female
   Male
4) Length of each first-generation mysid alive at the end of the study
   Female
   Male
5) Incidence of pathological or histological effects;
6) Observations of other effects or clinical signs.
1.) Survival of 1[st] generation (G1, F0) mysids.
2.) Number of live young produced per female.
3.) Dry weight of each 1[st] generation (G1, F0) mysid alive at the end of the test (male and female).
4.) Length of each 1[st] generation (G1, F0) mysid alive at the end of the test (male and female).
5.) Abnormal development was recorded (G1, F0 and G2, F1).
6.) Aberrant behavior was recorded if it occurred (G1, F0 and G2, F1).
7.) Survival of 2[nd] generation (G2, F1) mysids

Raw data included? (Y/N)
At a minimum, individual data should be included for:
1) Surviving 1st generation  and  mysids.
2) Number of live young produced per female.
3) Individual length measurements of  and  mysids.
4) Individual dry weight measurements for  and  mysids at the end of the test.
Raw data including individual data for each replicate and test compartment was provided, with one exception.  The data for the number of live young produced per living female, was not provided, though the supporting data needed to calculate the endpoint were provided.

Comments: For each female the number of reproductive days was defined as the number of days that the female was alive from the day of first brood release of any female in the test to the end of the test. Therefore, if a female dies the number of reproductive days ends on the last day that she was alive. The percent surviving females producing young and number of your per surviving female were calculated based on the total number of surviving females present at test termination. Females that died during the test prior to test termination and the young that they produced were excluded from the calculation of percent females producing the mean number of young per female. The day of first brood release (by any female) was reported as Day 17. This parameter was not assessed as a toxicological endpoint by the study author; however, the reviewer analyzed this parameter as part of the verification of statistical analysis. All live young produced were included for the reproductive endpoints.

Effects Data:

1[st] generation (G1, F0)
                                Toxicant Conc.
                                  (ug ai/L)
                           Percent Survival (Mean)*
Nominal
Mean-measured
                            Pre-Pairing (Days 0-14)
                         Post-Pairing (Days 14-28)[1]
Negative control
                                 <LOQ[(a)]
                                      100
                                    81 (85)
Solvent control
                                 <LOQ[(a)]
                                      95
                                    86 (85)
13
                                      10
                                      95
                                    87 (87)
25
                                      21
                                      98
                                    88 (95)
50
                                      39
                                      100
                                    84 (80)
100
                                      76
                                      95
                                    86 (86)
200
                                      157
                                      97
                                    86 (88)
[a] LOQ = 7.50 ug a.i./L
* Study author found that there were no statistically significant decreases in survival in comparison to the pooled, negative or solvent control using Fisher's Exact test (p > 0.05).
[1] Reviewer-calculated numbers differed slightly in some cases and are presented in parentheses.

There were no treatment-related effects on survival, either before pairing or afterward. Before pairing, survival was 100 and 95%, respectively, in the negative and solvent control.  Survival ranged from 95 to 100% in the treatment groups. After pairing, survival was 81 and 86%, respectively, in the negative and solvent control. Survival ranged from 84 to 88% in the treatment groups.  The reported NOAEC for survival both pre- and post-pairing was 157 ug a.i./L.

                                Toxicant Conc.
                                  (ug ai/L)
                       Reproduction (mean or mean +- SD)
Nominal
Mean-measured
                  Number of Young Per Reproductive Day +- SD
                     Percent of Females Producing Young[1]
                   Number of Offspring per Surviving Female
                                   +- SD[1]
Negative control[2]
                                 <LOQ[(a)]
                                0.429 +- 0.204
                                      90
                                  5.2 +- 2.5
Solvent control[2]
                                 <LOQ[(a)]
                                 1.08 +- 0.461
                                      94
                                  13.5 +- 6.3
13
                                      10
                                0.590 +- 0.084
                                      100
                                  7.1 +- 1.0
25
                                      21
                                0.325 +- 0.136
                                      65
                                  3.9 +- 1.6
50
                                      39
                                0.351 +- 0.028
                                      75
                                  3.5 +- 1.5
100
                                      76
                                0.219 +- 0.072*
                                      79
                                  3.7 +- 2.1
200
                                      157
                                0.008 +- 0.017*
                                      7**
                                  0.1 +- 0.2*
[a] LOQ = 7.50 ug ai/L
* Study author determined there was a statistically significant decrease in reproduction and mean number of young per surviving female in comparison to the negative control using Dunnett's test (p < 0.05).
** Study author determined there was a statistically significant decrease in percent of surviving females producing young in comparison to the pooled control using Fisher's Exact test (p < 0.05).
[1] Calculated by the study author based on the total number of surviving females present at test termination. Females that died prior to test termination and the young that they produced were excluded from the calculation of the mean percent of females producing young and the mean number of young per female.
2 The study author determined that there was a statistically significant difference between the negative and solvent control groups (p < 0.05). The mean reproduction values in the solvent control group for this study were higher than normal when compared to historical control data. Therefore, comparisons were made to the negative control for the reproductive endpoint.

The percent of surviving females that produced young averaged 90 and 94% in the negative and solvent controls, respectively, as compared to 100, 65, 75, 79, and 7% in the mean-measured 10, 21, 39, 76, and 157 ug a.i./L treatment groups, respectively. The treatment groups were compared to the negative control. The number of young produced per surviving female averaged 5.2 and 13.5 in the negative and solvent controls, respectively, as compared to 7.1, 3.9, 3.5, 3.7, and 0.1 in the mean-measured 10, 21, 39, 76, and 157 ug a.i./L treatment groups, respectively.  The NOAEC for both endpoints was reported to be 76 ug a.i./L.

The number of young produced per reproductive day averaged 0.429 and 1.08 in the negative and solvent controls, respectively, as compared to 0.590, 0.325, 0.351, 0.219, and 0.008 in the mean-measured 10, 21, 39, 76, and 157 ug a.i./L treatment groups, respectively. The treatment groups were compared to the negative control. The NOAEC for this endpoint was reported to be 39 ug a.i./L.

Toxicant Conc.
(ug a.i./L)
                              Growth (mean +- SD)
Nominal
                                 Mean-measured
                            Total Body Length (mm)
                             Dry Body Weight (mg)

                                     Male
                                    Female
                                     Male
                                    Female
Negative control
                                 <LOQ[(a)]
                                 7.23 +- 0.170
                                 7.47 +- 0.141
                                 1.10 +- 0.131
                                 1.33 +- 0.048
Solvent control
                                 <LOQ[(a)]
                                 7.19 +- 0.195
                                 7.39 +- 0.187
                                 0.96 +- 0.093
                                 1.20 +- 0.177
13
                                      10
                                 6.87 +- 0.262
                                 7.27 +- 0.141
                                 0.90 +- 0.096
                                 1.17 +- 0.066
25
                                      21
                                 6.95 +- 0.038
                                 7.37 +- 0.130
                                 0.91 +- 0.015
                                 1.28 +- 0.012
50
                                      39
                                 6.83 +- 0.059
                                 7.15 +- 0.176
                                 0.87 +- 0.066
                                 1.17 +- 0.106
100
                                      76
                                 6.70 +- 0.202
                                 7.14 +- 0.215
                                 0.77 +- 0.102
                                 1.08 +- 0.178
200
                                      157
                                 6.20 +- 0.079
                                 6.42 +-0.207
                                 0.58 +- 0.059
                                 0.77 +- 0.045
a LOQ = 7.50 ug a.i./L

Total male body length averaged 7.23 and 7.19 mm in the negative and solvent controls, respectively.  In the treatment groups, total male body length averaged 6.87, 6.95, 6.83, 6.70, and 6.20 mm in the mean-measured 10, 21, 39, 76, and 157 ug a.i./L treatment groups, respectively. The treatment groups were compared to the pooled controls.  The NOAEC for male length was reported to be 21 ug a.i./L.

Male dry weight averaged 1.10 and 0.96 mg in the negative and solvent controls, respectively.  In the treatment groups, male dry weight averaged 0.90, 0.91, 0.87, 0.77, and 0.58 mg in the mean-measured 10, 21, 39, 76, and 157 ug a.i./L treatment groups, respectively. The treatment groups were compared to the pooled controls. The NOAEC for male weight was reported to be 21 ug a.i./L.

Total female body length averaged 7.47 and 7.39 mm in the negative and solvent controls, respectively. In the treatment groups, total female body length averaged 7.27, 7.37, 7.15, 7.14, and 6.42 mm in the mean-measured 10, 21, 39, 76, and 157 ug a.i./L treatment groups, respectively. The treatment groups were compared to the pooled controls. The NOAEC for female length was reported to be 21 ug a.i./L.

Female dry weight averaged 1.33 and 1.20 mg in the negative and solvent controls, respectively. In the treatment groups, female dry weight averaged 1.17, 1.28, 1.17, 1.08, and 0.77 mg in the mean-measured 10, 21, 39, 76, and 157 ug a.i./L treatment groups, respectively. The treatment groups were compared to the pooled controls. The NOAEC for female weight was reported to be 39 ug a.i./L.

2[nd] generation (G2, 2[nd] generation, F1)
Toxicant Conc.
(ug a.i./L)
                            Percent Survival (Mean)
Nominal
                                 Mean-measured
                                After 96 hours
Negative control
                                 <LOQ[(a)]
                                      61
Solvent control
                                 <LOQ[(a)]
                                      92
13
                                      12
                                      83
25
                                      23
                                      25
50
                                      45
                                      68
100
                                      84
                                      100
200
                                      175
                                    --[(b)]
a LOQ = 7.50 ug a.i./L
b The required number of live young were not produced.

Survival averaged 61 and 92% in the negative and solvent control, respectively. In the treatment groups, survival ranged from 25 to 100%. The controls were pooled for analysis and used for comparison. Although a statistically significant reduction was determined for the 23 ug a.i./L treatment group, this was based on a sample size of 4 mysids, and the two higher treatment groups lacked statistically significant decreases. The reported NOAEC for G2 survival was 84 ug a.i./L.

Toxicity Observations:

1[st] generation (G1, F0):

Surviving mysids in the controls and 10, 21, 39, and 76 ug a.i./L treatment groups mostly appeared normal from test initiation to pairing on Day 14. Some organisms appeared smaller than the controls, but these observations were infrequent. Mysids in the 157 ug a.i./L treatment group exhibited signs of a smaller size as compared to the controls.

Surviving mysids in the treatment groups mostly appeared normal from Day 14 to Day 28. Some organisms exhibited lethargy or got stuck above the waterline, but these observations were infrequent.

2[nd] generation (G2, F1):

Generally, the young produced by the first generation (G1) were dead, lethargic, or appeared normal, and did so consistently throughout the controls and treatment groups. After collection, surviving mysids in the controls and treatment groups appeared normal with a few cases of lethargy and erratic swimming during the 96-hour evaluation period.

All live young produced were included for the reproductive endpoints; however, only live G2 mysids that were produced were used to initiate the G2 phase of the study. Only a few live G2 mysids were collected or available for the 96 hour test for further observations (Appendix 17 vs Appendix 20 of the study report, respectively), and no live G2 mysids were collected for the highest test concentration, although two young were produced (indicating they died before the G2 phase began; G2 175 ug a.i./L level; the 157 ug a.i./L G1 level, respectively).  However, based on the information that was provided in the Appendices from the study report the total number of dead F1 young in the negative and solvent controls and treatment groups was estimated by the reviewer (Appendix II).

Statistical Results:

The study authors analyzed G1 (F0) and G2 (F1) survival, G1 (F0) reproduction endpoints, and G1 (F0) growth endpoints (total body length and dry weight).  First, the negative and solvent control were compared using an appropriate statistical test.  No differences were detected for survival or growth, so the control data were pooled for comparison among the treatment groups. There were significant differences between the controls for the reproductive endpoints. The mean reproductive values in the solvent control group for this study were higher than normal when compared to historical control data (Appendix 6 of the study report). Therefore, the study authors compared the treatment group data to the negative control.

Survival and percent of surviving females producing young were considered to be discrete variable data and were analyzed using the Chi-square and Fisher's Exact tests. The number of young produced per reproductive day, the number of young produced per surviving female, and growth data were classified as continuous variable data.  All continuous data were evaluated for normality and homogeneity of variance using Shapiro-Wilk's and Levene's test, respectively (p = 0.01).  All data were normal with homogeneity of variance.  The growth endpoints were analyzed using Jonckheere-Terpstra's trend test, and the reproduction data were analyzed using Dunnett's test (p <= 0.05).

The mean-measured test concentrations were used for the analysis.  All statistical tests were conducted using SAS software.

Endpoint
Method
                                     NOEC
                                     LOEC
                                     MATC
G1 (F0) Survival
Chi-square and Fisher's Exact tests
                                      157
                                    >157
                                      --
G1 (F0) percent of surviving females producing young
Chi-square and Fisher's Exact test
                                      76
                                      157
                                      --
G1 (F0) Number of young produced per reproductive day
Dunnett's test
                                      39
                                      76
                                      --
G1 (F0) Number of young produced per surviving female
Dunnett's test
                                      76
                                      157
                                      --
G1 (F0) Dry weight, female
Jonckheere-Terpstra's trend test
                                      39
                                      76
                                      --
G1 (F0) Dry weight, male
Jonckheere-Terpstra's trend test
                                      39
                                      76
                                      --
G1 (F0) Total length, female
Jonckheere-Terpstra's trend test
                                      76
                                      157
                                      --
G1 (F0) Total length, male
Jonckheere-Terpstra's trend test
                                      21
                                      39
                                      29
G2 (F1) Survival
Chi-square and Fisher's Exact tests
                                      84
                                    >84
                                      --

Endpoint(s) Affected:   All reproductive and growth endpoints
Most Sensitive Endpoint(s):  G1 male total length

12.	REVIEWER'S STATISTICAL RESULTS:

     The reviewer analyzed F0 survival (pre- and post-pairing), F0 time to first brood, F0 reproduction (offspring per female), F0 growth (sex-specific dry weight and length), and F1 survival (96 hours) using CETIS statistical software version <IP_ADDRESS> with database backend settings implemented by EFED on 10/20/2015.

     F1 96-hr survival was analyzed via the Fisher Exact/Bonferroni-Holm test and was not subjected to analyses of normality and homogeneity of variance. Other endpoints were tested for normality using the Shapiro-Wilk's test (α = 0.01) and for homogeneity of variance using either Bartlett's or Levene's tests (α = 0.01). Female dry weight data did not meet both assumptions but was monotonic and was analyzed using the non-parametric Jonckheere-Terpstra step-down test.

     Female length, number of offspring per surviving female, and male dry weight and length data met both assumptions and were monotonic (or roughly monotonic as was the case for time to first brood); therefore, the data were analyzed using William's multiple comparison test.

     F0 survival pre-pairing data did not meet both assumptions and was non-monotonic; therefore, the data were analyzed using the Mann-Whitney U two-sample test. F0 post-pairing survival met both assumptions but were not monotonic; therefore, the data were analyzed using Dunnett's multiple comparison test.

     All analyses were conducted using the mean-measured concentrations (refer to copy of Excel worksheet in Appendix III), and all tests were conducted at α = 0.05 unless specified otherwise.

     Most sensitive endpoint: F0 Male dry weight and length

Endpoint
Method
                                     NOAEC
                                 (ug a.i./L)
                                     LOAEC
                                 (ug a.i./L)
F0 Pre-pairing survival
Mann-Whitney U two-sample t-test
                                      157
                                    >157
F0 Post-pairing survival
Dunnett's
                                      157
                                    >157
Offspring/female*
Jonckheere-Terpstra Step-Down*
                                      10
                                      21
Time to first brood
William's
                                      39
                                      76
F0 male total length
William's
                                    <10
                                      10
F0 female total length
William's
                                      21
                                      39
F0 male dry weight
William's
                                    <10
                                      10
F0 female dry weight
Jonckheere-Terpstra Step-Down
                                      39
                                      76
F1 96-hr survival
Fisher Exact/Bonferroni-Holm
                                      84
                                    >84
    * The solvent control was statistically significantly different from the negative control (p=0.04), with 159% more offspring/female produced in the solvent control.  A clear dose-response relationship was also observed when comparing the treatment groups to the solvent control as opposed to the negative control.  Therefore, the reviewer determined that comparisons for this endpoint should be made against the solvent control.

General Comments:

 The reviewer's results for female dry weight, and F0 and F1 survival were in agreement. However, for the remaining growth endpoints and number of offspring per surviving female, the reviewer's results differed from the study authors. The reviewer's NOAEC and LOAEC values were an entire test level lower than the study authors. For these growth endpoints, this was most likely due to the study authors using a non-parametric test for monotonic data (Jonckheere-Terpstra) whereas the reviewer used parametric tests for monotonic data (William's) as the assumptions of equal variance and normality were met. For the number of offspring per surviving female, the study authors interpreted the data as non-monotonic, whereas the reviewer interpreted the data as monotonic. Additionally, the study authors did not analyze time to first brood, which was an affected endpoint. Additionally, for time to first brood, despite not being statistically significantly different, the NOAEC and LOAEC was determined observationally using the William's test to be 39 and 76 ug a.i./L, respectively. The reviewer's results are reported in the Conclusions section of this DER.

 The study authors only reported the mean number of offspring per surviving female, they did not report the number of offspring per surviving female for each replicate. The reviewer independently calculated the endpoint and entered those values into CETIS (Appendix I). As a result, the reviewer's replicate means differed slightly from the study authors'. But it had not impact on the results for this endpoint. Additionally, the reviewer determined that there were statistically significantly more offspring produced per female in the solvent control than the negative control (p=0.04, Equal Variance t Two-Sample Test using a two-tailed test).  Additionally, the reviewer observed a clear dose-response relationship compared to the solvent control that could not be observed compared to the negative control. Therefore, the reviewer determined endpoints for this effect by comparing treatment groups to the solvent control.  Due to the statistically significant differences, the study author evaluated results against the negative control (rather than the pooled controls) and determined statistically significant effects only at the highest dose, while the reviewer, comparing against the solvent control determined statistically significant dose-responsive effects at all doses above the lowest dose. The study author did not present results from the study range-finder to see if this trend in solvent and treatment groups for offspring production was observable prior to the definitive test.  The reviewer's results are reported in the Conclusions section of this DER.

The in-life portion of the definitive toxicity test was conducted from August 28, 2013 to September 29, 2013.

Only the total live young produced was provided, a count of the total number young produced per day comparing the number of dead versus live young produced was not provided. A total of dead vs. live young that were initially observed, was never quantified by the study authors and so it is not clear how many were actually lost to cannibalism by the G1 parents or G2 cohorts or if they may have actually been lost due to treatment. However based on the information that was provided in the Appendices from the study report the total number of dead F1 young in the negative and solvent controls, 85, 87, respectively, as compared to 74, 51, 35, and 2 in the mean-measured 10, 21, 39, 76, and 157 ug a.i./L treatment groups, respectively (Appendix II). Given the difference in young produced and live young available for the G2 phase of the experiment this information is especially important (Appendix 17 vs. Appendix 20 in the study report, respectively). Again, the study authors provided no rationale; however it can be postulated that the difference was attributed to potential cannibalism (either from G1 mysids or G2 cohorts), which is a possibility; however, given the great difference, this seems may not be the only reason. Although not explicitly stated, with the information presented for G2 live young for the highest test concentration, young were indeed produced (only 2 young, in one replicate); however, no live G2 mysids were collected for the highest test concentration, indicating that the two young that were produced died before the G2 phase began. Based on the information that was provided in the Appendices from the study report the total number of dead F1 young in the negative and solvent controls and treatment groups was estimated by the reviewer (Appendix II).

13. CONCLUSIONS:

   This study is scientifically sound and is classified as supplemental and may be used for risk characterization. After 28 days reproductive and growth effects were observed in all of the treatment groups. However, there were no effects on survival for the F0 (G1 mysids) or F1 (G2 mysids) exposure groups. Based on the observed effects, the NOAEC/LOAEC value <10/10 ug a.i./L using the mean-measured concentrations, and the most sensitive endpoints, F0 Male dry weight and length.

   Although no significant differences were observed between the solvent and negative controls, there was a potential slight interaction with the solvent and the test substance for the F0 male dry weight endpoint (13% decrease in solvent control compared to negative control; p = 0.07) and a statistically significant difference between the number of offspring per surviving female produced in the solvent control compared to the negative control (159% increase in solvent control compared to negative control; p= 0.04), resulting in uncertainty that the solvent may have had an impact on these endpoints.

   Since a definitive NOAEC could not be established in the study as dose-responsive effects on male weight and length were observed at all doses, additional data may be necessary including test concentrations less than the lowest test concentration used in this study, in order to establish a definitive NOAEC. It is also recommended that any new test consider whether a different solvent may be more appropriate, as there may be an interaction between the test substance and the solvent.

   NOAEC: <10 ug a.i./L
   LOAEC: 10 ug a.i./L

   Endpoint(s) Affected: All reproductive and growth endpoints (e.g., F0 Male dry weight and 	length; Offspring/female; Time to first brood; F0 Female dry weight and length)
   Most sensitive endpoint(s): F0 Male dry weight and length

14.	REFERENCES:

U.S. Environmental Protection Agency. 1996.  Series 850-Ecological Effects Test Guidelines (draft), 	OPPTS Number 850.1350: Mysid Chronic Toxicity Test.

American Society for Testing and Materials. 2008.  ASTM Standard E1191-03a: Standard Guide for 	Conducting Life-Cycle Toxicity Tests with Saltwater Mysids.

The SAS System for Windows. 1999-2001. Version 8.2. The SAS Institute, Inc., Gary, North Carolina.
APPENDIX I.  COPY OF EXCEL SPREADSHEET CALCULATION OF OFFSPRING PER FEMALE:

APPENDIX II.  COPY OF EXCEL SPREADSHEET CALCULATION OF TOTAL DEAD F1 YOUNG

APPENDIX III.  COPY OF EXCEL SPREADSHEET WITH MEASURED CONCENTRATIONS


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

CHEMICAL SAFETY AND

POLLUTION PREVENTION

MEMORANDUM

November 10, 2010

SUBJECT:	Prodiamine: Human Health Risk Scoping Document in Support of
Registration Review

PC Code:  110201	DP Barcode:  380297

Decision No.:  437638	Registration No.: NA

Petition No.:  None	Regulatory Action: Registration Review

Assessment Type: Scoping Document	Reregistration Case No.: NA

TXR No.:  None	CAS No.: 29091-21-2

MRID No.:  None	40 CFR: NA

FROM:		Becky Daiss, Biologist

	Risk Assessment Branch 4

	Health Effects Division (7509P)

		Office of Pesticide Programs

THROUGH:	Susan Hummel, Senior Scientist

		Risk Assessment Branch 4

		Health Effects Division (7509P)

		Office of Pesticide Programs

TO:		Barbara Brisco, Chemical Review Manager

Pesticide Re-evaluation Division

		Risk Management and Implementation Branch IV

Executive Summary

Attached is Health Effects Division’s (HED) human health risk
assessment status update for prodiamine as part of the Registration
Review process.  Prodiamine is a selective, preemergent herbicide used
for control of many grasses and broadleaf weeds.  It is available in
multiple formulations and applied using a variety of application
methods.  An analysis of available toxicity studies and an assessment of
occupational and residential exposure were conducted for prodiamine in
December, 1991 in support of a registration decision document issued in
February, 1992.

 	The 1991 HED occupational and residential exposure assessment risk
assessment was conducted in support of a new chemical registration
decision for prodiamine.  That assessment concluded that residential and
worker risks were not of concern for the proposed new uses.  A dietary
exposure risk assessment was not conducted at that time because
prodiamine was not registered for use on food commodities.

HED’s problem formulation conclusions are as follows.  1) Existing
State and Local Needs (SLN) uses on irrigation drainage ditches need to
be reviewed to determine if the uses constitute a food use.  If so,
tolerances may be needed on fish, shellfish, irrigated crops and exposed
livestock, and a dietary and drinking water exposure assessment needs to
be conducted.  2) An updated drinking water exposure assessment is
required. 3) Existing Section 3 labels for registered products provide
for use of prodiamine on residential lawns.  Therefore a quantitative
residential exposure assessment is needed.  3) An updated occupational
exposure assessment is needed.  4) An aggregate risk assessment may be
required pending reevaluation of potential dietary and residential
exposures.  5) Data evaluation records (DERs) for available toxicity
studies need to be reevaluated and updated based on current policies and
procedures.  5) A comprehensive, integrated review of submitted
toxicological studies is required for the purpose of selecting
appropriate endpoints for risk assessment.  6) A subchronic inhalation
toxicity study is required based on the registered uses and application
methods.  7) An immunotoxicity study is required under 40 CFR Part 158
as a part of the new data requirements for registration of a pesticide
(food and non-food uses).

Introduction

HED has evaluated the existing human health risk assessments for
prodiamine to determine whether sufficient data are available and
whether a new human health risk assessment is needed to support
Registration Review.  HED has considered the most recent risk
assessments for prodiamine, updates to its toxicity, exposure and usage
databases, and current Agency science policies and risk assessment
methods.

Use Profile

Prodiamine is a selective 2,6-dinitroaniline herbicide used for
pre-emergence control of many grasses and broadleaf weeds in non-crop
areas such as rights-of-ways, conifer and hardwood seedling nurseries,
established perennial and wildflower plantings, established turf sites,
residential and institutional lawns, commercial sod farms, golf courses,
railways, and landscape ornamentals.  There are also State and Local
Needs (SLN) registrations in CA and AZ for use on irrigation drainage
ditches, spreading grounds, channels, canals, and levees in wastewater
treatment facilities for pre-emergent control of shallow germinating
annual grasses.  These applications can be made only when the ditch is
not in use.  The mode of action of prodiamine is to inhibit root growth
by blocking plant cell division steps needed for chromosome separation
and cell wall formation.  Registered prodiamine products are applied by
foliar spray, broadcast, band treatment by sprayer, aircraft, or low
pressure ground equipment and spot treatment by spreader.  Residential
exposures to prodiamine can occur as a result of homeowner application
or by entering previously treated areas (e.g., residential lawns, parks,
golf courses).

Chemical Identity

Common name	Prodiamine

IUPAC name	5-dipropylamino-α,α,α-trifluoro-4,6-dinitro-o-toluidine

CAS #	29091-21-2

Hazard Identification/Toxicology

The toxicity data base for prodiamine is substantially complete.  The
available toxicity studies have been reviewed, data evaluation records
(DERs) have been generated, and NOAELs and LOAELs have been identified
for individual studies.  The available studies and results are
summarized in a 1991 HED Peer Review Committee document.  However, a
hazard profile summarizing salient toxicity findings (e.g., primary
target organ effects, developmental and reproduction toxicity etc.) has
not been completed.  Neither has a comprehensive, coordinated review of
the available toxicity data for the purposes of identifying points of
departure (PODs) for use in risk assessment been conducted.  Prodiamine
exhibits low acute toxicity via inhalation, dermal (Toxicity Category
III) and oral (Category IV) routes of exposure.  Based on the most
recent cancer evaluation of prodiamine, conducted by the HED
Carcinogenicity Peer Review Committee in 1991 (6/10/91), prodiamine was
classified as a Group C carcinogen.  The Committee further recommended
use of the reference dose (RfD) approach for quantitation of human risk.
 Acute and subchronic neurotoxity studies were required as part of the
conditional registration of prodiamine in 1992.  These studies,
submitted by the registrant in 1994, have been reviewed by HED and
determined to be acceptable.

Data Requirements

A subchronic inhalation toxicity study is required based on the
registered uses and application methods (i.e., ground and aerial
broadcast and hand held spray).  An immunotoxicity study is required as
a part of new data requirements in the 40 CFR Part 158 for conventional
pesticide registration.  Because the immune system is highly complex,
studies not specifically conducted to assess immunotoxic endpoints are
inadequate to characterize a pesticide’s potential immunotoxicity.
While data from hematology, lymphoid organ weights, and histopathology
in routine chronic or subchronic toxicity studies may offer useful
information on potential immunotoxic effects, these endpoints alone are
insufficient to predict immunotoxicity.  In the absence of required
studies, EPA may use a database uncertainty factor of up to 10X.  Once
all of the newly required toxicity data have been received and reviewed,
the Prodiamine Registration Review Team recommends that the points of
departure and safety factors be reexamined and a new risk assessment
done, if necessary.

Conclusions

The toxicity data base for prodiamine is substantially complete.
However, DERs for the available toxicity studies need to be reevaluated
and updated based on current HED/OPP policies and procedures.  In
addition, a comprehensive evaluation of the available toxicity data is
needed for the purpose of selecting points of departure (PODs) based on
current endpoint selection criteria for all potential routes of exposure
for registered uses of prodiamine.  A subchronic inhalation study is
required based on uses and application methods.  An immunotoxicity study
is required under the updated 40 CFR Part 158 requirements. Required
study summaries and rationales are provided in Appendix A.

Dietary Exposures

There were no registered food uses of prodiamine in 1992 when the
assessment for the registration decision document was conducted.
Therefore, a dietary exposure assessment was not required.  However, SLN
registrations issued between 2005 and 2008 provide for use of prodiamine
on irrigation ditches.  These SLN registrations need to be evaluated to
determine whether this use may be considered a food use under current
criteria.  If so, tolerances are needed on fish, shellfish, irrigated
crops and livestock exposed to treated water and a dietary and drinking
water exposure assessment is needed.  A quantitative drinking water
assessment has not been conducted for prodiamine.  A drinking water
assessment will need to be completed as part of the human health dietary
risk assessment.  Tier I Estimated Drinking Water Concentrations (EDWCs)
for human health assessments will be estimated using EFED’s aquatic
models FIRST for surface water and SCI-GROW  for ground water.  If
needed, Tier II EDWCs in surface water will be estimated using PRZM and
EXAMS models.

Data Requirements

If existing uses in irrigation ditches are determined to constitute a
food use, the registrant would need to submit all of the studies
required by the Agency to determine the levels of pesticide residues in
water, fish, and irrigated crops when products are applied directly to
water.  The data are used in dietary risk assessment and to establish
tolerances in treated/exposed commodities for enforcement purposes.

Conclusions

Existing State and Local Needs (SLN) uses on irrigation drainage ditches
need to be reviewed to determine if the uses constitute a food use.  If
so, tolerances are needed on water, fish, shellfish, irrigated crops,
and livestock exposed to treated water and a dietary and drinking water
exposure assessment is needed.  If not, a dietary exposure assessment is
not required.   An updated quantitative drinking water assessment is
required for Reregistration Review.

Residential Exposure

A residential exposure assessment was conducted for prodiamine in
December, 1991.  That assessment concluded that since prodiamine does
not have quantifiable carcinogenic risk and does not involve repeated or
chronic exposure, exposure and risk to residents/bystanders is assumed
to be negligible.  Therefore, a quantitative residential exposure
assessment was not conducted at that time.  HED policies, standard
operating procedures, and exposure assessment methodologies have changed
significantly since the residential exposure assessment was conducted in
1991.  In addition, a number of registrations for use of prodiamine on
turf have been accepted in recent years.  Consequently, a new
quantitative assessment of residential exposure and risk from currently
registered uses of prodiamine is required.

Conclusions

A quantitative residential exposure assessment is required.

Aggregate Exposure

An aggregate risk assessment integrates the assessments conducted for
dietary/drinking water and residential exposure.  Since dietary and
residential exposures were not assessed in previous risk assessments
conducted for prodiamine, an aggregate assessment was not required.
However, an aggregate assessment may be needed in an updated risk
assessment depending on the results of EPA’s reevaluation of the need
for dietary and/or drinking water assessments.

Conclusions

An aggregate exposure assessment may be required based on a reevaluation
of dietary, drinking water, and residential exposures.

Occupational Exposure

An occupational exposure assessment addressing both cancer and
non-cancer risks was conducted for prodiamine in December, 1991.
Scenarios assessed were mixing, loading and applying a 65% a.i. wettable
granular formulation to turf and landscape areas with groundboom or
handwand equipment.  The assessment was conducted using surrogate
exposure data for cyproconazole.  PODs for both dermal and inhalation
exposure were selected by the Occupational and Residential Exposure
Branch from a chronic feeding study in rats.  Dermal and inhalation
absorption were assumed to be 100%.  Estimated MOEs were 1600 for the
mixer/loader and 13000 for applicators.

Conclusions

An new occupational risk assessment is needed for the Registration
Review of prodiamine in light of significant changes to standard
exposure protocols, assumptions and algorithms and to incorporate
updated dermal and inhalation PODs identified as part of an updated
hazard identification assessment.

Incident Report

An updated incident report was recently conducted.  Based on the low
frequency of incident cases, there does not appear to be a concern at
this time that would warrant further investigation. The Agency will
continue to monitor the incident information and if a concern is
triggered, additional analysis will be included in the risk assessment.

Endocrine Disruption

EPA is required under the FFDCA, as amended by FQPA, to develop a
screening program to determine whether certain substances (including all
pesticide active and other

ingredients) “may have an effect in humans that is similar to an
effect produced by a

naturally occurring estrogen, or other such endocrine effects as the
Administrator may

designate.”   Following recommendations of its Endocrine Disruptor and
Testing Advisory

Committee (EDSTAC), EPA determined that there was a scientific basis for
including, as

part of the program, the androgen and thyroid hormone systems, in
addition to the estrogen

hormone system.  EPA also adopted EDSTAC’s recommendation that the
Program include

evaluations of potential effects in wildlife. For pesticide chemicals,
EPA will use FIFRA

and, to the extent that effects in wildlife may help determine whether a
substance may have

an effect in humans, FFDCA authority to require the wildlife
evaluations. As the science

develops and resources allow, screening of additional hormone systems
may be added to the

Endocrine Disruptor Screening Program (EDSP).  When additional
appropriate screening and/or testing protocols being considered under
the Agency’s EDSP have been developed, prodiamine may be subjected to
further screening and/or testing to better characterize effects related
to endocrine disruption.

Cumulative

EPA does not have, at this time, available data to determine whether
prodiamine has a common mechanism of toxicity with other substances.
EPA has not made a common mechanism of toxicity finding for prodiamine
and any other substances and, prodiamine does not appear to produce a
toxic metabolite produced by other substances which have tolerances in
the U. S.  Therefore, EPA has not assumed that prodiamine has a common
mechanism of toxicity with other substances.

Human Studies

The occupational exposure assessment relied in part on data from a study
in which adult human subjects were intentionally exposed to the
surrogate pesticide cyproconazole.  This study has not been reviewed as
required under EPA’s Rule for the protection of Human Subjects of
Research (40 CFR Part 26).  However, any future occupational and/or
residential assessments conduct for prodiamine will be based on data
contained in HEDs generic pesticide exposure databases such as the
Pesticide Handlers Exposure Database (PHED), the Agricultural Reentry
Task Force (ARTF) Database and the Outdoor Residential Exposure Task
Force (ORETF) Database.  EPA has reviewed all the studies supporting
these multi-pesticide generic exposure databases, and has found no clear
and convincing evidence that the conduct of any of them was either
fundamentally unethical or significantly deficient relative to the
ethical standards prevailing at the time the research was conducted.
All applicable requirements of EPA’s Rule for the Protection of Human
Subjects of Research (40 CFR Part 26) have been satisfied, and there is
no regulatory barrier to continued reliance on these studies.

Conclusions/Future Actions Needed

The actions needed in the future Registration Review for prodiamine are
listed below.

Hazard Identification and Endpoint Selection

The available prodiamine toxicity studies need to be re-evaluated for
purposes of hazard identification and endpoint selection.  PODs for all
routes of exposure need to be identified for use in risk assessment.  An
immunotoxicity study is required in accordance with the revised 40 CFR
Part 158 Toxicology Data Requirements.  A subchronic inhalation toxicity
study is required based on the registered uses and application methods
(i.e., ground and aerial broadcast and hand held spray).

Dietary Exposure and Risk

A dietary exposure assessment is needed if existing uses of prodiamine
in irrigation ditches are determined to constitute a food use.  An
updated quantitative drinking water assessment is required for
Reregistration Review.

Residential Exposure and Risk

A residential risk assessment needs to be conducted in accordance with
current policies and SOPs.

Aggregate Exposure and Risk

An aggregate exposure assessment may be needed based on updated dietary
and/or residential exposure assessments.

Occupational Exposure and Risk

The existing occupational exposure assessment needs to be reevaluated
and revised based on an updated toxicity assessment and current refined
exposure assumptions and algorithms.

Incident Report

The Agency will continue to monitor the incident information and if a
concern is triggered, additional analysis will be included in the risk
assessment.

Data Requirements

Toxicology

- 	28 Day Inhalation Toxicity Study (GLN 870.3465)

- 	Immunotoxicity study (GLN 870.7800)

Residue Chemistry

The following data will be required if existing uses of prodiamine are
determined to include products registered for use on food commodities.

- 	860.1300 - Nature of the Residue--Plants, Livestock

-	860.1380 - Storage Stability Data

-	  HYPERLINK
"http://www.regulations.gov/fdmspublic/ContentViewer?objectId=0900006480
9bc3a4&disposition=attachment&contentType=pdf"  860.1400 - Water, Fish,
Irrigated Crops

-	  HYPERLINK
"http://www.regulations.gov/fdmspublic/ContentViewer?objectId=0900006480
9bc3bc&disposition=attachment&contentType=pdf"  860.1480 -
Meat/Milk/Poultry/Eggs

-	  HYPERLINK
"http://www.regulations.gov/fdmspublic/ContentViewer?objectId=0900006480
9bc3bf&disposition=attachment&contentType=pdf"  860.1500 - Crop Field
Trials

-	  HYPERLINK
"http://www.regulations.gov/fdmspublic/ContentViewer?objectId=0900006480
9bc3c0&disposition=attachment&contentType=pdf"  860.1520 - Processed
Food/Feed (August 1996)

-	  HYPERLINK
"http://www.regulations.gov/fdmspublic/ContentViewer?objectId=0900006480
9bc3f2&disposition=attachment&contentType=pdf"  860.1850 - Confined
Accumulation in Rotational Crops

-	  HYPERLINK
"http://www.regulations.gov/fdmspublic/ContentViewer?objectId=0900006480
9bc3f3&disposition=attachment&contentType=pdf"  860.1900 - Field
Accumulation in Rotational Crops

References

Exposure Assessment for New Chemical, Prodiamine, Using Surrogate Data.
A. Mehta (12/17/91, D169921)

Peer Review of Prodiamine. J. Chen (3/28/91)

Registration of Prodiamine. A. Lindsay (2/7/92)

Prodiamine: Review of Human Incidents.  Karlyn Middleton, Shanna Recore,
and Khin Oo (D380376, 8/20/10)

Appendix A

Guideline Number:  870.3465

Study Title:   28-Day Inhalation - Rat

Rationale for Requiring the Data

This study is required under the updated data requirements at 40 CFR
158.500 because prodiamine is applied as a high volume, high pressure
spray so there is a likelihood of significant repeated exposure to
applicators.  As discussed in the footnotes at 40 CFR 158.500, a
non-guideline 21- or 28-day study is sufficient in situations such as
this where intermediate-term rather than chronic exposure is expected.
A 21- or 28-day study would be considerably less costly for the
registrant to conduct.

Practical Utility of the Data

How will the data be used?

The 28-inhalation toxicity study would allow EPA to properly
characterize the hazard and risks to occupational workers associated
with applying prodiamine as an aerosol.

How could the data impact the Agency’s future decision-making?

In the absence of inhalation toxicity data, EPA would have to estimate
inhalation risks using oral toxicity studies and relying on the
assumption that absorption and toxicity of prodiamine are the same via
the oral and inhalation routes of exposure.  Receiving the inhalation
data would allow the Agency to refine its estimates of inhalation risks,
to ensure that those risks are not overestimated or underestimated.

Guideline Number: 870.7800

Study Title:  Immunotoxicity

Rationale for Requiring the Data

This is a new data requirement under 40 CFR Part 158 as a part of the
data requirements for registration of a pesticide (food and non-food
uses).

The Immunotoxicity Test Guideline (OPPTS 870.7800) prescribes functional
immunotoxicity testing and is designed to evaluate the potential of a
repeated chemical exposure to produce adverse effects (i.e.,
suppression) on the immune system. Immunosuppression is a deficit in the
ability of the immune system to respond to a challenge of bacterial or
viral infections such as tuberculosis (TB), Severe Acquired Respiratory
Syndrome (SARS), or neoplasia.  Because the immune system is highly
complex, studies not specifically conducted to assess immunotoxic
endpoints are inadequate to characterize a pesticide’s potential
immunotoxicity.  While data from hematology, lymphoid organ weights, and
histopathology in routine chronic or subchronic toxicity studies may
offer useful information on potential immunotoxic effects, these
endpoints alone are insufficient to predict immunotoxicity.

Practical Utility of the Data

How will the data be used?

Immunotoxicity studies provide critical scientific information needed to
characterize potential hazard to the human population on the immune
system from pesticide exposure. Since epidemiologic data on the effects
of chemical exposures on immune parameters are limited and are
inadequate to characterize a pesticide’s potential immunotoxicity in
humans, animal studies are used as the most sensitive endpoint for risk
assessment.  These animal studies can be used to select endpoints and
doses for use in risk assessment of all exposure scenarios and are
considered a primary data source for reliable reference dose
calculation. For example, animal studies have demonstrated that
immunotoxicity in rodents is one of the more sensitive manifestations of
TCDD (2,3,7,8-tetrachlorodibenzo-p-dioxin) among developmental,
reproductive, and endocrinologic toxicities.  Additionally, the EPA has
established an oral reference dose (RfD) for tributyltin oxide (TBTO)
based on observed immunotoxicity in animal studies (IRIS, 1997).

How could the data impact the Agency's future decision-making?

If the immunotoxicity study shows that the test material poses either a
greater or a diminished risk than that given in the interim decision’s
conclusion, the risk assessments for the test material may need to be
revised to reflect the magnitude of potential risk derived from the new
data.

If the Agency does not have this data, a 10X database uncertainty factor
may be applied for conducting a risk assessment from the available
studies.

Page   PAGE  1  of   NUMPAGES  10


[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Proposed Rules]
[Pages 52055-52057]
[FR Doc No: 2019-20927]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 60

[EPA-HQ-OAR-2010-0960; FRL-10000-43-OAR]

Call for Information: Information Related to the Development of
Emission Estimating Methodologies for Animal Feeding Operations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Call for information.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) is soliciting
quality-assured emissions and process data, and calculation models and
methodologies that are relevant to developing emission estimating
methodologies (EEMs) for emissions of volatile organic compounds (VOC)
from animal feeding operations (AFOs). The EPA may use the data to
supplement the emissions and process data collected under the National
Air Emission Monitoring Study (NAEMS) for AFOs.

DATES: Information must be received on or before December 2, 2019.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OAR-2010-0960, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov/
(our preferred method). Follow the online instructions for submitting
comments.
     Email<EMAIL_ADDRESS>Include Docket ID No. EPA-
HQ-OAR-

2010-0960 in the subject line of the message.
     Fax:<PHONE_NUMBER>. Attention Docket ID No. EPA-HQ-OAR-
2010-0960.
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center, Docket ID No. EPA-HQ-OAR-2010-0960, Mail Code 28221T, 1200
Pennsylvania Avenue NW, Washington, DC 20460.
     Hand/Courier Delivery: EPA Docket Center, WJC West
Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004.
The Docket Center's hours of operation are 8:30 a.m.-4:30 p.m., Monday-
Friday (except federal holidays).
    Instructions: All submissions received must include the Docket ID
No. for this rulemaking. Comments received may be posted without change
to https://www.regulations.gov/, including any personal information
provided. For detailed instructions on sending comments and additional
information on the rulemaking process, see the SUPPLEMENTARY
INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: For questions about this Call for
Information, contact Mr. William Schrock, Sector Policies and Programs
Division (E143-03), Office of Air Quality Planning and Standards, U.S.
Environmental Protection Agency, Research Triangle Park, North Carolina
27711; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
and email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Docket. The EPA has established a docket for this rulemaking under
Docket ID No. EPA-HQ-OAR-2010-0960. All documents in the docket are
listed in Regulations.gov. Although listed, some information is not
publicly available, e.g., Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
internet and will be publicly available only in hard copy. Publicly
available docket materials are available either electronically in
Regulations.gov or in hard copy at the EPA Docket Center, Room 3334,
WJC West Building, 1301 Constitution Avenue NW, Washington, DC. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the EPA
Docket Center is<PHONE_NUMBER>.
    Instructions. Direct your comments to Docket ID No. EPA-HQ-OAR-
2010-0960. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at https://www.regulations.gov/, including any personal
information provided, unless the comment includes information claimed
to be CBI or other information whose disclosure is restricted by
statute. Do not submit information that you consider to be CBI or
otherwise protected through https://www.regulations.gov/ or email. This
type of information should be submitted by mail as discussed below.
    The EPA may publish any comment received to its public docket.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the Web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
    The https://www.regulations.gov/ website allows you to submit your
comment anonymously, which means the EPA will not know your identity or
contact information unless you provide it in the body of your comment.
If you send an email comment directly to the EPA without going through
https://www.regulations.gov/, your email address will be automatically
captured and included as part of the comment that is placed in the
public docket and made available on the internet. If you submit an
electronic comment, the EPA recommends that you include your name and
other contact information in the body of your comment and with any
digital storage media you submit. If the EPA cannot read your comment
due to technical difficulties and cannot contact you for clarification,
the EPA may not be able to consider your comment. Electronic files
should not include special characters or any form of encryption and be
free of any defects or viruses. For additional information about the
EPA's public docket, visit the EPA Docket Center homepage at https://www.epa.gov/dockets.
    Submitting CBI. Do not submit information containing CBI to the EPA
through https://www.regulations.gov/ or email. Clearly mark the part or
all of the information that you claim to be CBI. For CBI information on
any digital storage media that you mail to the EPA, mark the outside of
the digital storage media as CBI and then identify electronically
within the digital storage media the specific information that is
claimed as CBI. In addition to one complete version of the comments
that includes information claimed as CBI, you must submit a copy of the
comments that does not contain the information claimed as CBI directly
to the public docket through the procedures outlined in Instructions
above. If you submit any digital storage media that does not contain
CBI, mark the outside of the digital storage media clearly that it does
not contain CBI. Information not marked as CBI will be included in the
public docket and the EPA's electronic public docket without prior
notice. Information marked as CBI will not be disclosed except in
accordance with procedures set forth in 40 Code of Federal Regulations
(CFR) part 2. Send or deliver information identified as CBI only to the
following address: OAQPS Document Control Officer (C404-02), OAQPS,
U.S. Environmental Protection Agency, Research Triangle Park, North
Carolina 27711, Attention Docket ID No. EPA-HQ-OAR-2010-0960.
    Call for Information acronyms and abbreviations. We use multiple
acronyms and terms in this Call for Information. While this list may
not be exhaustive, to ease the reading of this Call for Information and
for reference purposes, the EPA defines the following terms and
acronyms here:

AFOs animal feeding operations
CBI Confidential Business Information
EEMs emission estimating methodologies
NAEMS National Air Emission Monitoring Study
SAB Science Advisory Board
VOC volatile organic compounds

I. General Information

A. What is the purpose of this action?

    In 2005, the EPA offered AFOs an opportunity to participate in a
voluntary consent agreement (70 FR 4958, January 31, 2005) referred to
as the Air Compliance Agreement. Under the Air Compliance Agreement,
participating AFOs were responsible for, among other things, the
funding for NAEMS--a 2-year, nationwide industry-run emissions
monitoring study of the broiler, egg-layer, swine, and dairy
industries. Monitoring under NAEMS began in the summer of 2007 and it
occurred at 25 monitoring sites located in 10 states. The study
collected process and emissions data for ammonia, hydrogen sulfide,
particle pollution, and VOC from a representative sample of animal

housing structures and manure storage and treatment units across the
country.
    The EPA plans to use these data to develop EEMs for AFOs, which
will help AFOs determine and comply with any applicable regulatory
responsibilities under the Clean Air Act. Additional information
regarding NAEMS can be found at: https://www.epa.gov/afos-air/national-air-emissions-monitoring-study.
    In the January 2005 Federal Register document, the EPA committed to
using data generated from NAEMS and all other available, relevant data
to develop EEMs. On January 19, 2011, the EPA published a call for
information to obtain emissions and process data for animal confinement
and manure storage and treatment processes at beef, broiler, dairy,
egg-layer, swine, and turkey AFOs (76 FR 3060). Using the NAEMS data
and the data obtained through the 2011 call for information, the EPA
developed draft EEMs for broiler confinement operations and for open
lagoons and basins at swine and dairy operations. In 2013, the EPA
requested that the Science Advisory Board (SAB) conduct a review of
these draft EEMs and provide feedback regarding the development of the
methodologies. As noted by the SAB in their March 19, 2013, review
summary, and reaffirmed by recent EPA data reviews, peer-reviewed data
regarding VOC emissions from AFOs are limited.\1\ Through the Call for
Information in this document, the EPA is requesting that interested
parties submit VOC emissions and process data available since 2011 that
are relevant to the EPA's effort to develop EEMs for animal confinement
and manure storage and treatment processes at broiler, dairy, egg-
layer, and swine AFOs, particularly for open sources at dairy and swine
operations (e.g., lagoons and basins).
---------------------------------------------------------------------------

    \1\ See https://www.epa.gov/afos-air/national-air-emissions-monitoring-study#naems-sab.
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B. What specific information is the EPA seeking?

    The EPA is requesting data for VOC emissions from animal
confinement and manure storage and treatment processes at broiler, egg-
layer, swine, and dairy AFOs and related process information.
Consistent with the Air Compliance Agreement, the EPA is focusing in
the near term on developing EEMs for AFOs using statistical models.
However, we acknowledge the recommendation that the EPA develop a
process-based modeling approach that incorporates ``mass balance''
constraints to determine emissions from AFOs, made by the National
Academy of Sciences in its December 2002 final report titled Air
Emissions from Animal Feeding Operations: Current Knowledge, Future
Needs. In their 2013 review, the SAB also recommended that the EPA
develop process-based models for estimating emissions from AFOs. As
noted in the EPA's 2013 response to the SAB review, we will carefully
consider its recommendations and we will review all of the information
available to us in developing the AFO EEMs. To ensure compatibility
with the NAEMS data, the emissions and related process data provided to
the EPA should be accompanied, if possible, by documentation that
contains detailed descriptions of the following parameters, as
applicable.
    1. General information:
     Description of AFO process measured (e.g., animal
confinement structure; manure storage and treatment unit; land
application site).
     Location of AFO process measured (e.g., physical address,
latitude/longitude coordinates of facility).
     Beginning and ending dates of the monitoring period.
    2. Monitoring data:
     Quality assurance and quality control plan.
     Site monitoring plan.
     Test methods, instrumentation, and standard operating
procedures used to collect emissions and process data measurements.
     Results of audits conducted on instruments and procedures.
     Field notes and associated documentation collected during
the monitoring.
     Emissions data (unanalyzed or analyzed) and associated
process data.
     Meteorological data, including average ambient
temperature, relative humidity, pressure, wind speed, wind direction,
and insolation (solar radiation) for each day that the study was
conducted.
     Production data (e.g., number of eggs produced per day or
quantity of milk produced per day).
     Calculations and assumptions used to convert concentration
data (e.g., parts per million by volume) into mass emissions (e.g.,
pounds per hour).
    3. Animal confinement structures:
     Dimensions of structures monitored.
     Designed and permitted animal capacity.
     Type, age, number, and weight of animals contained in the
confinement structure over the duration of the monitoring period.
     Manure management system (e.g., pull-plug pit, scrape).
     Dates of production and manure management activities over
the duration of the monitoring period.
     Ventilation method (i.e., natural or mechanical).
     Calculations and assumptions used to estimate the
ventilation rate of the monitored confinement structure.
     Calibration procedures for instruments (e.g., flow meters,
fan relays) used to collect data for calculating ventilation rate of
the monitored confinement structure.
     Data on air temperature and relative humidity within the
structure for each day that the study was conducted.
     Organics content of process inputs and outputs (e.g.,
feed, water, bedding, eggs, milk).
     Organics content of manure excreted.
     Description of any control device or work practice used in
the monitored structure to reduce emissions.
    4. Manure storage and treatment processes:
     Type, age, number, and weight of animals contributing
manure to the storage and treatment process over the monitoring period.
     Dimensions of storage/treatment unit monitored (e.g.,
storage pile, tank, lagoon).
     Depth of settled solids in storage/treatment unit.
     Temperature, pH, and reduction/oxidation potential of
manure contained in the storage/treatment unit.
     Moisture, total solids, volatile solids, organic content,
total Kjeldahl nitrogen, and ammoniacal nitrogen content and pH of
manure entering storage and treatment process over the monitoring
period.
    With regard to the format of the information, we request that
emissions, process, and production data be submitted to the EPA in
Microsoft[supreg] Excel[supreg] spreadsheet or Access[supreg] database
format. In cases where the emissions, process, and production data
correspond to time increments shorter than 1 hour, please provide
sufficient information and supporting documentation with the data to
allow the EPA to develop emission estimates on a per-hour and per-day
basis. For all formats, please clearly label the units of measure of
emissions, process, and production data submitted.

    Dated: September 18, 2019.
Anne L. Idsal,
Acting Assistant Administrator.
[FR Doc. 2019-20927 Filed 9-30-19; 8:45 am]
BILLING CODE 6560-50-P