Dow A3r0St.:ic nces LLC 

9330 Zions' ille Road 

ndianapoli~. I 46268- 1 05~ 

308/2E 

July I , 2009 

Document Processing Desk 

Office of Pesticide Programs (7504P) 

U.S. Environmental Protection Agency 

One Potomac Yard 

2777 S. Crystal Drive 

Arlington, VA 22202 

cc: Tom Myers (7505P) 

AI: Chlorpyrifos 

CHEM1CAL CODE: 59101 

G MDow AgroSciences 

ADDITIONAL INFORMATION TO SUPPORT HSRB REVIEW OF CHLORPYRIFOS STUDIES 

Enclosed please find additional information regarding conduct of the Kisicki, 1999 human volunteer 

study (MRID 448 11002) as requested by John Carley via his June 24, 2009 email. The forms I am 

forwarding were received from the original test facility, MDS Harris Labs (now MDS Pharma 

Services), and were described in a cover letter from MDS as comprising the log wherein prospective 

volunteers indicated they had listened to an audio tape of the Informed Consent Form during the 

screening process. Since the original sheets I received contained personal information such as names, 

addresses, and SSN' s, a sanitized copy is being provided to the EPA which excludes this information 

and obscures the full details of the signatures. Hopefully this information will be useful in 

documenting the type of informed consent process which occurred with the volunteer candidates 

during the screening process. Please let me know if there is any further information or clarification 

the Agency may require. 

Contents of Submission 

Volume 

Volume l 

Contents 

• Transmittal document (this letter) 

• Complimentary copy of documents from MDS Pharma Services 

If you require additional information, please contact me or Joyce Carroll, Registration 

Assistant for this product, at 3 17-337-463 1. 

Kenneth D. Racke, Ph.D. 

Regulatory Leader - Regulatory Affairs 

317-337-4654 

317-337-4649 (FAX) 
. . - HARRIS LABORATORIES, INC . Lincoln, Ne Usa 

Screening List - Full 

Screen Date : 21-SEP- 1998 06:00 

St udy Number: 21438 

Group ID: 1 

HID 

3 

4 

8 

15 

17 

22 

25 

32 

34 

36 

45 

Printed: 21-SEP-1998 05:36 

Signature 

~ -·L------------

t_--···· 

========= == == ============= ================= == == ========================= ~~ ======= 

VOLUNTEERS ARE TO SIGN BESIDE THEIR NAME AFTER LISTENING TO THE INFORMED CONSENT FORM, 

IF THEY UNDERSTAND IT AND HAVE NO FURTHER QUESTIONS 
HARRIS LABORATORIES, INC. 

Lincoln, Ne Usa 

Screening List - Full 

Screen Date: 21-SEP-1998 06: 00 

Study Number: 21438 

Group ID: 1 

HID 

51 

54 

65 

66 

72 

74 

78 

81 

82 

83 

84 

Printed: 21-SEP-1998 05:36 

Signature 

-----

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

-- -- ---------------- ---------- -------- --- --------- --------- VOLUNTEERS ARE TO SIGN BESIDE THEIR NAME AFTER LISTENING TO THE INFORMED CONSENT FORM, 

IF THEY UNDERSTAND IT AND HAVE NO FURTHER QUESTIONS 
HARRIS LABORATORIES, INC. 

Lincoln, Ne Usa 

Screening List - Full 

Screen Date: 21-SEP-1998 06:00 

Study Number: 21438 

Group ID: 1 

HID 

86 

89 

93 

101 

104 

111 

112 

115 

116 

121 

125 

7136$_--

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Printed: 21-SEP-1998 05 : 36 

Signature 

===================================================================================~=~==~===== 

VOLUNTEERS ARE TO SIGN BESIDE THEIR NAME AFTER LISTENING TO THE INFORMED CONSENT FORM, IF THEY UNDERSTAND IT AND HAVE NO FURTHER QUESTIONS 
HARRIS LABORATORIES, INC. 

Lincol n, Ne Usa 

Screening List - Full 

Screen Date: 21- SEP- 1998 06:00 

Study Number: 21438 

Group ID: 1 

HID 

126 

173 

206 

207 

225 

234 

236 

237 

240 

242 

246 

Pri nted: 21-SEP-1998 05:36 

Signature 

·-------------

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·-------------

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

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

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----··--------

================================================================== =================~==~====== 

VOLUNTEERS ARE TO SIGN BESIDE THEIR NAME AFTER LISTENING TO THE INFORMED CONSENT FORM, 

IF THEY UNDERSTAND IT AND HAVE NO FURTHER QUESTIONS 
HARRIS LABORATORIES, INC. 

Lincoln, Ne Usa 

Screening List - Full 

Screen Date: 21-SEP-1998 06:00 

Study Number: 21438 

Group ID: 1 

HID 

248 

249 

250 

251 

252 

253 

255 

257 

258 

259 

260 

Printed: 21-SEP-1998 05:36 

Signature 

----

~ 

---------

====================================================================================~~~~====== 

VOLUNTEERS ARE TO SIGN BESIDE THEIR NAME AFTER LISTENING TO THE INFORMED CONSENT FORM, IF THEY UNDERSTAND IT AND HAVE NO FURTHER QUESTIONS 
HARRIS LABORATORIES, INC. 

Lincoln, Ne Usa 

Screening List - Full 

Screen Date: 21-SEP-1998 06:00 

Study Number: 21438 

Group ID: 1 

HID 

261 

262 

264 

267 

268 

270 

272 

273 

274 

275 

276 

Printed: 21- SEP-1998 05 :36 

Signature 

===================================== =================================== ==========~~~======== 

VOLUNTEERS ARE TO SIGN BESIDE THEIR NAME AFTER LISTENING TO THE INFORMED CONSENT FORM, I F THEY UNDERSTAND IT AND HAVE NO FURTHER QUESTIONS 
HARRIS LABORATORIES, INC. 

Screen Date: 21-SEP-1998 06:00 

Study Number: 21438 

Group ID: 1 

HID 

277 

278 

279 

282 

284 

285 

286 

287 

290 

291 

292 

Lincoln, Ne Usa 

Screening List - Full 

~--. I ·-

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-~

Printed: 21-SEP-1998 05:36 

Signature 

===============================~=~===:==~ ==== =~==~=~~~=== ==============~====== ~======~== === 

VOLUNTEERS ARE TO SIGN BESIDE THEIR NAME AFTER LISTENING TO THE INFORMED CONS~~· FORM, IF THEY UNDERSTAND IT AND HAVE NO FURTHER QUESTIONS 
HARRIS LABORATORIES, INC. 

Lincoln, Ne Usa 

Screening List - Full 

Screen Date: 21-SEP-1998 06:00 

Study Number: 21438 

Group ID: 1 

------------------------- ·-----··· 

HID 

293 

294 

295 

296 

300 

301 

302 

303 

~ ' I 

304 

305 ~---

306 

Printed: 21-SEP-1998 05:36 

Signature 

===~==========~~========~=========== ============= ========= ==== ~~~=~=============~==~~==~==== 

VOLUNTEERS ARE TO SIGN BESIDE THEIR NAME AFTER LISTENING TO THE INFORMED CONSE1"1' fORM, 

IF THEY UNDERSTAND IT AND HAVE NO FURTHER QUESTIONS 
HARRIS LABORATORIES, INC. Lincoln, Ne Usa 

Screening List - Full 

Screen Date: 21-SEP-1998 06:00 

Study Number: 21438 

Group ID: 1 

HID 

307 

308 

309 

312 

313 

314 

315 

316 

317 

318 

319 

Printed: 21-SEP-1998 05:36 

Signature 

======================= ================= === ==== =========================== == =========~====== 

VOLUNTEERS ARE TO SIGN BESIDE THEIR NAME AFTER LISTENING TO THE INFORMED CONSEN·l' .FORM, 

IF THEY UNDERSTAND IT AND HAVE NO FURTHER QUESTIONS 
HARRIS LABORATORIES, INC. 

Lincoln, Ne Usa 

Screening List - Full 

Screen Date: 21-SEP-1998 06:00 

Study Number: 21438 

Group ID: 1 

HID 

320 

322 

323 

324 

326 

329 

330 

Printed: 21-SEP-1998 05:36 

Signatu,re 

===================================================================== == ============~===~====== VOLUNTEERS ARE TO SIGN BESIDE THEIR NAME AFTER LISTENING TO THE INFORMED CONSENT FORM, IF THEY UNDERSTAND IT AND HAVE NO FURTHER QUESTIONS 
HARRIS LABORATORIES, INC. 

Lincoln, Ne Usa 

Screening List - Full 

Screen Date: 06-0CT-1998 06:00 

Study Number: 21438 

Group ID: 2 

HID 

133 

219 

222 

235 

281 

339 

350 

359 

363 

370 

406 

Printed: 06-0CT-1998_04:53 

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Signature 

========================== ================================ ======== ==== ===========~ =~==~====== 

VOLUNTEERS ARE TO SIGN BESIDE THEIR NAME AFTER LISTENING TO THE INFORMED CONSENT FORM, 

IF THEY UNDERSTAND IT AND HAVE NO FURTHER QUESTIONS 
HARRIS LABORATORIES, INC. 

Lincoln, Ne Usa 

Screening List - Full 

Screen Date: 06-0CT-1998 06:00 

Study Number: 21438 

Group ID: 2 

HID 

448 

449 

468 

469 

476 

477 

478 

479 

480 

481 

484 

Printed: 06-0CT-1998 04:53 

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================================ ================== ============= == ========== =========~~~~====== 

VOLUNTEERS ARE TO SIGN BESIDE THEIR NAME AFTER LISTENING TO THE INFORMED CONSENT FORM, 

IF THEY UNDERSTAND IT AND HAVE NO FURTHER QUESTIONS 
HARRIS LABORATORIES, INC. 

Screen Date: 06-0CT-1998 06:00 

Study Number: 21438 

Group ID: 2 

HID 

485 

487 

488 

489 

490 

491 

492 

493 

494 

495 

496 

Lincoln, Ne Usa 

Screening List - Full 

Printed: 06-0CT-1998 04:53 

Signature 

========== ============== =================== ======== =============== === ============~=~==~====== 

VOLUNTEERS ARE TO SIGN BESIDE THEIR NAME AFTER LISTENING TO THE INFORMED CONSENT FORM, 

IF THEY UNDERSTAND IT AND HAVE NO FURTHER QUESTIONS 
HARRIS LABORATORIES, INC. 

Lincoln, Ne Usa 

Screening List - Full 

Screen Date: 06-0CT-1998 06:00 

Study Number: 21438 

Group ID: 2 

HID 

497 

498 

499 

501 

502 

503 

504 

507 

509 

510 

511 

Printed: 06-0CT-1998 04:53 

Signature 

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========== ============== ============ ==== ============== ========== =================~== ====== 

VOLUNTEERS ARE TO SIGN BESIDE THEIR NAME AFTER LISTENING TO THE INFORMED CONSENT FORM, 

IF THEY UNDERSTAND IT AND HAVE NO FURTHER QUESTIONS 
HARRIS LABORATORIES, INC. 

Lincoln, Ne Usa 

Screening List - Full 

Screen Date: 06-0CT-1998 06:00 

Study Number: 21438 

Group ID: 2 

HID 

513 

514 

515 

516 

517 

518 

519 

521 

522 

523 

526 

Printed: 06-0CT-1998 04:53 

_____ Signature __ ____ .;..._ 

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=================================================================================~=~==~======= 

VOLUNTEERS ARE TO SIGN BESIDE THEIR NAME AFTER LISTENING TO THE INFORMED CONSENT FORM, 

IF THEY UNDERSTAND IT AND HAVE NO FURTHER QUESTIONS 
HARRIS LABORATORIES, INC. Lincoln, Ne Usa 

Screening List - Full 

Screen Date: 06-0CT-1998 06:00 

Study Number: 21438 

Group ID: 2 

HID 

528 

529 

530 

531 

532 

534 

535 

536 

537 

538 

539 

Printed: 06-0CT- 1998 04:53 

Signature 

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============================================================;================================= 

VOLUNTEERS ARE TO SIGN BESIDE THEIR NAME AFTER LISTENING TO THE INFORMED CONSrNT r0RM, 

IF THEY UNDERSTAND IT AND HAVE NO FURTHER QUESTIONS 
HARRIS LABORATORIES, INC. 

Lincoln, Ne Usa 

Screening List - Full 

Screen Dat e: 06-0CT- 1998 06: 00 

Study Number: 21438 

Group ID: 2 

HID 

540 

541 

542 

543 

544 

545 

546 

547 

548 

549 

550 

Printed: 06-0CT- 1998 04:53 

Signature 

=== =================== ================== === ======================================~=========== 

VOLUNTEERS ARE TO SIGN BESIDE THEIR NAME AFTER LISTENING TO THE INFORMED CONS&~ .£' £0RM, 

IF THEY UNDERSTAND IT AND HAVE NO FURTHER QUESTIONS 
HARRIS LABORATORIES, INC . Lincoln, Ne Usa 

Screening List - Full 

Screen Date: 06-0CT-1998 06:00 

Study Number: 21438 

Group ID: 2 

HID 

551 

552 

553 

554 

555 

556 

557 

558 

559 

560 

561 

Printed : 06 -0CT-1998 04:53 

Signature 

{------------

================ ===== =============================================================;:==~======= 

VOLUNTEERS ARE TO SIGN BESIDE THEIR NAME AFTER LISTENING TO THE INFORMED CONSENT FORM, 

IF THEY UNDERSTAND IT AND HAVE NO FURTHER QUESTIONS 
HARRIS LABORATORIES, INC. 

Lincoln, Ne Usa 

Scr eening List - Full 

Screen Date: 06-0CT-1998 06:00 

Study Number: 21438 

Group ID: 2 

HID 

562 

563 

565 

566 

568 

569 

571 

572 

578 

579 

Printed: 06-0CT-1998 04:53 

Si gnature 

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--------- -------------------------------- ---------------------------------- ------ ------------ ---------------- ------ ------------- ---------- --------- ---------- -------·-- ------------- -------- VOLUNTEERS ARE TO SIGN BESI DE THEIR NAME AFTER LISTENING TO THE INFORMED CONSENT FORM, 

IF THEY UNDERSTAND IT AND HAVE NO FURTHER QUESTIONS