Document ID: EPA-HQ-OPP-2005-0061-0211
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-02-27T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

							                                         OFFICE OF

				PREVENTION, PESTICIDES

	AND TOXIC SUBSTANCES

	

To:  	AZM Docket

	EPA-HQ-OPP-2005-0061

From:	Katie Hall

	OPP/SRRD

Date:	January 29, 2007

Re:	Note to Docket documenting AZM registrant request for HASPOC review

At a meeting on January 23, 2007 with the Office of Pesticide Programs
Health Effects Division (HED), Ephi Gur of Makhteshim Agan of North
America (MANA) and Larry Hodges of Bayer CropScience requested a HASPOC
review for the AZM toxicology database.  Please see attached agenda. 
EPA agreed that this request constitituted the request for HASPOC review
contemplated by paragraph 5 of Bayer’s and MANA’s 11/06 requests to
amend the terms and conditions of their AZM registrations.  EPA has set
a tentative date of March 8 for the HASPOC review.   Based on that date,
the registrants have noted that they intend to provide a detailed HASPOC
review package to HED by February 22, 2007.  

Agenda

Azinphos methyl

(AZM)

January 23, 2007

0900 – 1000

One Potomac Yard, 2777 South Crystal Drive, Arlington, VA 22202

Tenth Floor

Purpose: Discussion to set the Agenda for the AZM HAZPOC review. 

Participants (currently planned):

US EPA

Cathy Eiden, Tina Levine, Vicki Dellarco, Margaret Rice, Tom Myers,
Katie Hall 

Makhteshim Agan of North America, Inc

		Ephi Gur, Elliot Gordon

Bayer CropScience

		Larry Hodges

	

Topics:

1. AZM regulatory and scientific background.

	a. Agency WOE evaluation of March 17, 2006.

b. HSRB review of AZM 28-day repeat dose human study of April 5, 2006 

(Minutes: May 15, 2006; Final Report: June 26, 2006).

	c. Agency revised Occupational Risk Assessment of June 6, 2006.

2. Interspecies Uncertainty Factor.

	a. Basis for 1x interspecies UF (EPA position of March 17, 2006).

	b. EPA’s rationale for 10x UF (EPA position of June 6, 2006).

		i). Exclusion of human data.

		ii). Concern for “steep dose-response”

3. Proposed Charge to the HAZPOC.

a. Conduct an independent evaluation of the Inveresk 1999 repeat-dose
human study to ascertain whether is it sufficiently robust to be
considered in the WOE risk characterization for AZM (McFarlane, 1999).

i). Two other human studies* and the animal data as a whole should be
considered in this evaluation. *An acute toxicity study (single dose) in
humans (McFarlane, 1998) and a human dermal absorption study (Selim,
1999)).

ii). The individual data should be reviewed to ascertain the statistical
power present in the study.

b. Review data that speak to the issue of dose-response for AZM. 

i). Analysis of the dose differential between measurable levels of AChE
depression and levels of AChE depression that cause adverse effects.

ii). The relevance of the dose-response curve for occupational risk
assessment.

4. Discussion of proposed charge.

5. Conclusion 

	a. Agreement as to the Charge to the HAZPOC.

	b. Schedule of the HAZPOC meeting.

c. Registrant actions in preparation for and participation in the HAZPOC
review.