Document ID: EPA-HQ-OPP-2011-0374-0013
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2022-04-28T04:00Z

OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C.  20460
OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C.  20460

VIA EMAIL 									

Mr. Jon C. Wood
AMVAC Chemical Corporation
4695 MacArthur Court, Suite 1200
Newport Beach, CA 92660

Subject: Notification of Outstanding Data Requirements, and Anticipated Registration Review Schedule for DCPA 

Dear Mr. Wood: 

EPA is contacting AMVAC to confirm that the Agency intends to complete all Registration Review Interim Decisions by October 1, 2022 for all pesticides registered as of October 1, 2007, fifteen years after the initiation of Registration Review. In order to meet this deadline for DCPA, EPA expects to complete the draft risk assessments in June 2021. A substantial portion of the data required in the Data Call-In (DCI) (see below) has not yet been submitted and is outstanding. The Agency will rely upon data available at the time when the risk assessments are being developed. Where the Agency is lacking data, conservative assumptions may be used in their place to complete the risk assessments.  

In 2013, the Agency issued a Generic DCI for DCPA which has not been completely satisfied:
 Generic Data Call-In GDCI-078701-1140, dated January 31, 2013 
   
Please arrange for the generation and submission of any data which is not waived. The status of data required is listed in the table attached to this letter. 

You are requested to respond within seven days to acknowledge receipt of this letter and to provide a response in 30 days indicating how you intend to satisfy the remaining data requirements, including a timeline for the generation and submission of outstanding data. EPA would like to remind AMVAC that completion and submission of required studies will not necessarily lead to changes in the risk estimates or safety factors used in the Draft Risk Assessment. These data are required by the DCI and, if submitted in a timely manner, EPA expects to use them in Registration Review to assess the risks of the chemical. If you have any questions, please feel free to contact James Douglass in writing at douglass.james@epa.gov.
						

                              Sincerely,

						

						Elissa Reaves, PhD
						Acting Division Director,
						Pesticide Re-evaluation Division
						Office of Pesticide Programs

Attachment-- Status of DCPA GDCI-078701-1140 with Current Due Dates (as of October 16, 2020)

cc Ed Messina
    Alexandra Dapolito Dunn, Esq.
Attachment--Status of DCPA GDCI-078701-1140 with Current Due Dates (as of October 16, 2020)

Guideline No. 

Study Title
Study Status
Due Date
835.1230
Adsorption/desorption (TPA)
Supplemental, ; additional data not required.
01/31/2014
835.1240
Leaching (TPA)
In review
01/31/2014
835.2120
Hydrolysis (TPA)
Waived[2]

835.4100
Aerobic soil metabolism (TPA)
Supplemental2, ; additional data not required.
01/31/2015
835.4200
Anaerobic soil metabolism (TPA)
Waiver request denied: outstanding[2]
01/31/2015
835.4300
Aerobic aquatic metabolism (DCPA)
Supplemental2, ; additional data not required.
01/31/2015
835.4300
Aerobic aquatic metabolism (TPA)
Waiver request denied; outstanding[5]
01/31/2015
835.4400
Anaerobic aquatic metabolism (TPA)
Waiver request denied; outstanding
01/31/2015
835.6100
Terrestrial field dissipation (DCPA)
Waiver request denied; outstanding[5]
01/31/2015
835.6100
Terrestrial field dissipation (TPA)
Waiver request denied; outstanding[5]
01/31/2015
850.1010
Acute toxicity, freshwater invertebrates (daphnid) (DCPA)
In review
01/31/2014
850.1010
Acute toxicity, freshwater invertebrates (daphnid) (TPA)
In review
01/31/2014
850.1025
Acute toxicity, oyster (shell deposition) (DCPA)
In review
01/31/2014
850.1025
Acute toxicity, oyster (shell deposition) (TPA)
Waiver request denied; outstanding[5]
01/31/2014
850.1035
Acute toxicity, mysid (estuarine/marine invertebrate) (DCPA)
In review
01/31/2014
850.1035
Acute toxicity mysid, (estuarine/marine invertebrate) (TPA)
Waiver request denied; outstanding[5]
01/31/2014
850.1075
Acute toxicity, freshwater fish (rainbow trout) (DCPA)
In review
01/31/2014
850.1075
Acute toxicity, freshwater fish (bluegill sunfish) (DCPA) 
In review
01/31/2014
850.1075
Acute toxicity, estuarine/marine fish (sheepshead minnow) (DCPA)
In review
01/31/2014
850.1075
Acute toxicity, freshwater fish (rainbow trout) (TPA)
Waiver request denied; outstanding[5]
01/31/2014
850.1075
Acute toxicity, freshwater fish (bluegill sunfish) (TPA)
Waiver request denied; outstanding[5]
01/31/2014
850.1075
Acute toxicity, estuarine/marine fish (sheepshead minnow) (TPA)
Waiver request denied; outstanding[5]
01/31/2014
850.1300
Aquatic invertebrate life-cycle, freshwater (DCPA)
In review
01/31/2014
850.1300
Aquatic invertebrate life-cycle, freshwater (TPA)
In review
01/31/2014
850.1350
Aquatic invertebrate life-cycle, estuarine/marine (DCPA)
In review
01/31/2014
850.1350
Aquatic invertebrate life-cycle, estuarine/marine (TPA)
Waiver request denied; outstanding[5]
01/31/2014
850.1400
Fish early life-stage (rainbow trout) (DCPA)
Supplemental[,] ; additional data not required.
01/31/2014
850.1400
Fish early life-stage (bluegill sunfish) (DCPA)
Outstanding
01/31/2014
850.1400
Fish early life-stage (sheepshead minnow) (DCPA)
Outstanding
01/31/2014
850.1400
Fish early life-stage (rainbow trout) (TPA)
Waiver request denied; outstanding[5]
01/31/2014
850.1400
Fish early life-stage (bluegill sunfish) (TPA)
Waiver request denied; outstanding[5]
01/31/2014
850.1400
Fish early life-stage (sheepshead minnow) (TPA)
Waiver request denied; outstanding[5]
01/31/2014
850.1730
Fish bio-concentration (TPA)
Waived[5]

850.2100
Acute avian oral, passerine species (DCPA)
In review
01/31/2014
850.2300
Avian reproduction (DCPA)
Waived[5]
   
850.4100
Tier I Plant toxicity - Seedling Emergence (DCPA)
In review
01/31/2014
850.4100
Tier I Plant toxicity - Seedling Emergence (TPA)
Waiver request denied; outstanding[5]
01/31/2014
850.4150
Tier I Plant toxicity - Vegetative Vigor (DCPA)
In review
01/31/2014
850.4150
Tier I Plant toxicity - Vegetative Vigor (TPA)
Waived
01/31/2014
850.4400
Aquatic vascular plant growth
Tier I/II Plant toxicity (Lemna spp.) (DCPA)
In review
01/31/2014
850.4400
Aquatic vascular plant growth
Tier I/II Plant toxicity (Lemna spp.) (TPA)
Waiver request denied; outstanding[5]
01/31/2014
850.4500
Algal toxicity test, Tier I/II (DCPA)
In review
01/31/2014
850.4500
Algal toxicity test, Tier I/II (TPA)
Outstanding
01/31/2014
860.1300
Nature of the residue: poultry
In review; label amendments submitted to satisfy guideline
01/31/2015
860.1340
Residue analytical method: livestock commodities
In review; label amendments submitted to satisfy guideline
01/31/2015
860.1380
Storage stability
Satisfied
   
860.1480
Meat/milk/ poultry/eggs
In review; label amendments submitted to satisfy guideline
01/31/2015
860.1900
Field accumulation in rotational crops
In review; label amendments submitted to satisfy guideline
01/31/2016
870.3465
Subchronic inhalation toxicity study - 90 day
Satisfied
   
870.6200
Neurotoxicity battery 
Satisfied
   
870.7800
Immunotoxicity
Waived
   
SS-1066
Chronic Sediment - Hyalella azteca (DCPA)
In review
01/31/2015
SS-1069
Chronic Sediment - Chironomus dilutus (DCPA)
In review
01/31/2015
SS-1072
Chronic Sediment - Leptocheirus plumulosus (DCPA)
Waiver request denied; outstanding; Guideline 850.1740 (spiked whole sediment 10‐day toxicity test, saltwater invertebrates) may proceed in the interim and results may allow EPA to reconsider waiver request for SS-1072
01/31/2015
SS-1075
Avian inhalation toxicity (DCPA)
Waived on condition of limiting applications to ground applications only; waiver request denied if aerial applications remain on label.[2]
10/31/2013
SS-thyroid toxicity
Comparative thyroid study (DCPA)
Outstanding
01/31/2015