- 1

- OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460

D ate: September 3, 2015

PC Code: 0 59201

DP Barcode: D 428161

MEMORANDUM

SUBJECT: Response to Correspondence on Preliminary Review Findings for the Fish Short Term Reproduction Assay (OCSPP Guideline 890.1350) with Phosmet

TO: Joel Wolf

, Chemical Review Manager Tom Myers

, Team Leader

Kevi n Costello, Branch Chief Risk Management and Implementation Branch II

P esticide Re

- evaluation Division (750 5 P) Office of Pesticide Programs

FROM: Catherine Aubee

, Senior Scientist

Environmental Risk Branch IV

Environmental Fate and Effects Divisio n (7507P) Office of Pesticide Programs

THROUGH: Jean Holmes

, D.V.M., M.P.H., Branch Chief Thomas Steeger, Ph.D., Senior Science Advisor

Environmental Risk Branch IV Environmental Fate and Effects Division (7507P) Office of Pesticide Programs

Phosmet was among 67 chemicals for which Tier 1 Endocrine Disruptor Screening Program (EDSP) test orders were issued in 2009 and 2010 . A preliminary review of the submitted Tier 1 data for phosmet identified deficiencies in three of the eleven studies whi ch had potential to warrant repetition of the studies. Therefore, t he Agency provided a courtesy notification of the preliminary findings to the test order recipient, Gowan Company, on October 30, 2014 1

.

1 US EPA. 2014. EDSP

- 069201

- 54, Phosmet, Fish Short Term Reproduction, Male and Female Pubertals

– Response and Action Required. Email from R.P. Keigwin (c/o Tanja Crk, EPA) to E. Codrea (Gowan Company). October 30, 2014.- 2

- On June 2, 2015, the Agency received a response fr om Gowan Company to the preliminary review findings for the Fish Short Term Reproduction Assay (OCSPP Guideline 890.1350) (MRID 48673002) 2 . The test order recipient’s response was assigned a unique MRID (49643801) 3 and DP Barcode (D428161). The response provided concurrence for a number of the Agency’s preliminary review findings , including generalized signs of overt toxicity in two treatment levels and the absence of certain effects at specific treatment levels. However, the test order recipient disagr eed with the Agency’s preliminary findings regarding overt toxicity and decreased yolk synthesis in the low treatment level. The test order recipient also disagreed with the Agency’s preliminary findings regarding the impact of oocyte atresia in control f emales on the interpretation of study results. Finally, the test order recipient reported that i ts statistical analysis yielded conclusions that were different from the Agency’s preliminary conclusions for effects on survival and nuptial tubercle scores

. Overall, Gowan Company contended that the study was conducted consistent with the available test guideline and that repetition of the study was not warranted.

The Agency has since completed its review of the Fish Short Term Reproduction Assay, which is documented in a Data Evaluation Record (DER)

, indexed by MRID (48673002). The review concludes,

Although the mortality in the high treatment level, clinical signs of toxicity in the intermediate treatment level, and noteworthy rate of oocyte atresia in control females make the results difficult to interpret, when considered in context of other available Tier 1 EDSP data for phosmet, this study satisfies the EDSP Tier 1 Test Order requirement for a Fish

Short

- Term Reproduction Assay (OCSPP Guideline 890.1 350).

The results of this final review are also captured in the publicly available, EDSP Tier 1 weight of evidence analysis for phosmet (US EPA 2015 4 ).

2 York, D.O. 2012. Phosmet

– Short

- term Reproduction Assay with the Fathead Minnow ( Pimephales promelas ) Following OPPTS 890.1350 and OECD 229 Guidelines. Unpublished study performed by Smithers Viscient. Wareham, MA. Lab Study No. 12791.6143. Gowan Company. Yuma, AZ. MRID 48673 002.

3 E. Codrea. 2015. Response to Draft DER (DP Barcode D400673) on the Fish Short

- Term Reproduction Assay with Phosmet (MRID 48673002). Report No. MEC

- 2015

- 5. Gowan Company. Yuma, AZ. MRID 49643801.

4 US EPA. 2015. EDSP: Weight of Evidence Analys is of Potential Interaction with the Estrogen, Androgen, or Thyroid Pathaways [sic]. Chemical: Phosmet. TXR No. 0057145. Office of Pesticide Programs and Office of Science Coordination and Policy. Washington, DC. Available online at http://www2.epa.gov/sites/production/files/2015

- 06/documents/phosmet

- 059201_2015

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- 29_txr0057145.pdf

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