Reader’s Guide to Glutaraldehyde E-Docket #EPA-HQ-OPP-2007-0364

EPA has created this document to provide an organizational structure to
the Glutaraldehyde E-Docket.  The docket index groups related documents.
The first group contains the Federal Register and Docket Organizational
Documents.  The second group contains the Glutaraldehyde Human Health
and Ecological and Environmental Risk Assessment Document, the
supporting disciplinary science assessments, and correspondence from the
Phase 1 error-only comment period.  The Agency is providing the
“Reader’s Guide” to allow the reader to more easily access and
navigate the various items contained in the Glutaraldehyde electronic
docket.  The Agency is especially interested in receiving feedback
regarding the scientific and ethical considerations related to the use
of sensory endpoints for conducting inhalation risk assessments (Docket
Items 6, 7, 8, 9, and 10).

Group 1 - Federal Register and Docket Organizational Documents:

Docket Item 1. 	Federal Register Notice: Glutaraldehyde Risk Assessment;
Notice of Availability and Risk Reduction Options 

This document formally and publicly announces the glutaraldehyde risk
assessment is available for review on the internet or at the EPA’s
Office of Pesticides Programs’ Public Docket and solicits comments and
suggestions on the risk assessment and how to mitigate or address
potential risks of concern.

Docket Item 2. 	Reader’s Guide to the Glutaraldehyde E-Docket #
EPA-HQ-OPP-2007-0364.

This document is designed to annotate all the documents in the
Glutaraldehyde E-Docket

Group 2 - Human Health and Ecological and Environmental Effects Risk
Assessment Document and Correspondence for Phase 3 Public Comments:

Docket Item 3. 	GLUTARALDEHYDE: Antimicrobials Division’s Risk
Assessment for Issuance of the Reregistration Eligibility Decision (RED)
Document. Case No.  PC Code: 043901. 06/28/07 McMahon

This document describes all the human health and ecological risks from
the antimicrobial uses of glutaraldehyde.  These documents include
revisions based on the registrants (The Dow Chemical Company and BASF
Corporation) Phase 1 error correction comments.

Docket Item 4. 	GLUTARALDEHYDE: Toxicology Disciplinary Chapter for the
Issuance of the Reregistration Eligibility Decision (RED) Document. Case
No. 2315, PC Code: 043901.  06/28/07.  McMahon

This document characterizes the toxicological hazard associated with
potential exposures to glutaraldehyde based on labeled pesticide uses. 
This document includes revisions based on the registrants (The Dow
Chemical Company and BASF Corporation) Phase 1 error correction
comments.

Docket Item 5. 	Glutaraldehyde – Revised Report of the Antimicrobials
Division Toxicity Endpoint Selection Committee (ADTC). 06/28/07. McMahon

This document identifies all of the toxicological data available for
glutaraldehyde and provides a rationale for endpoint selection as well
as the factors and uncertainties used to determine the toxicological
hazards for this chemical. It also includes revisions based on the
registrants (The Dow Chemical Company and BASF Corporation) Phase 1
error correction comments.

Docket Item 6. 	Human Odor and Chemesthesis Data Evaluation Record Case
No. 2315, PC Code: 043901. 06/27/07.  Reaves

This document evaluates the data contained within a human study
submitted by the registrants (The Dow Chemical Company and BASF
Corporation)in December, 2006 as part of Phase 1 comments to the
Antimicrobials Division’s risk assessment document for glutaraldehyde.

Docket Item 7. 	Preliminary Ethics Review of a Human Study of
Glutaraldehyde Chemesthesis.  06/12/07  Carley

This document provides the Office of Pesticide Program’s preliminary
ethics review of the human study (Docket Item 6) for glutaraldehyde.  An
ethics review is required by the Agency’s Human Studies Review Board
for any human study being considered by the Agency for risk assessment
purposes.  

Docket Item 8. 	Letter to Dow; Cain study titled: “Odor and
Chemesthesis from Exposures to Glutaraldehyde Vapor.”  06/14/07. 
Hartman

This correspondence was sent to the registrant (The Dow Chemical
Company) informing them of preliminary study deficiencies (Docket Item
6; Human Odor and Chemesthesis Data Evaluation Record Case No. 2315, PC
Code: 043901. 06/27/07.  Reaves   

Docket Item 9. 	Letter to BASF; Cain study titled: “Odor and
Chemesthesis from Exposures to Glutaraldehyde Vapor.”  06/14/07. 
Hartman

This correspondence was sent to the registrant (BASF Corporation)
informing them of preliminary study deficiencies (Docket Item 6; Human
Odor and Chemesthesis Data Evaluation Record Case No. 2315, PC Code:
043901. 06/27/07.  Reaves

Docket Item 10. 	DOW/BASF; Response to EPA Letter and Attachment
Concerning the Cain Study, “Odor and Chemesthesis from Exposures to
Glutaraldehyde Vapor.”  06/25/07.  Maureen Mikstal (The Dow Chemical
Company) and Bernie Franc (BASF Corporation).

This correspondence was sent by the registrants (The Dow Chemical
Company and BASF Corporation) to the Antimicrobials Division in response
to Agency’s correspondence letters (Docket Items 8 and 9).

Docket Item 11. 	Dietary Risk Assessment for Glutaraldehyde
Reregistration Eligibility Decision (RED) Case No. 2315  PC Code:
043901.  06/27/07  Shamim

This document assesses the potential dietary risks from exposure to
glutaraldehyde based on its labeled pesticidal uses.  The document
includes revisions based on the registrants (The Dow Chemical Company
and BASF Corporation) Phase 1 error correction comments.

Docket Item 12. 	Glutaraldehyde: Revised Occupational and Residential
Exposure Assessment for the Reregistration Eligibility Decision (RED)
Case No. 2315  PC Code: 043901  DP Barcode: 327466.  06/27/07  Dole

This document assesses the potential occupational and residential risks
from exposure to glutaraldehyde and includes revisions based on the
registrants (The Dow Chemical Company and BASF Corporation) Phase 1
error correction comments.  This document includes an assessment of
glutaraldehyde use as a materials preservative in paint.  To assess
these risks, the Agency has used the Wall Paint Exposure Model (WPEM). 
However, the registrants have asked the Agency to consider an alternate
model for assessing these risks. The Agency anticipates submission of
this information in July, 2007.  

Docket Item 13. 	Revised Environmental Fate Science Chapter for the
Glutaraldehyde Risk Assessment as per the Registrants (DOW/BASF) Error
Correction Comments for the Reregistration Eligibility Decision (RED)
Process.  Case No. 2315  PC Code: 043901  DP Barcode: 324558.  06/21/07 
Gowda

This document describes the breakdown and environmental  fate of
glutaraldehyde and degadates in the environment.  This document includes
revisions based on the registrants (The Dow Chemical Company and BASF
Corporation) Phase 1 error correction comments.

Docket Item 14. 	Ecological Hazard and Environmental Risk Assessment of
glutaraldehyde for the Reregistration Eligibility Decision (RED);  PC
Code: 043901  DP Barcode D326916.  06/28/07  Petrie

This document describes the toxicity of glutaraldehyde to animals and
plants in the environment and includes revisions based on the
registrants (The Dow Chemical Company and BASF Corporation) Phase 1
error correction comments.

Docket Item 15. 	Review of Summary Document: “Probabilistic Ecological
Risk Assessment of Glutaraldehyde in Once-through Cooling Water
Systems.”  DP Barcode: none  PC Code:  043901.  06/05/07  Petrie

This document evaluates a probabilistic ecological risk assessment of
glutaraldehyde in once-through cooling water systems that was submitted
by the registrants (The Dow Chemical Company and BASF Corporation) in
May, 2007.

 

Docket Item 16. 	Glutaraldehyde – Incident Report Summary  PC Code:
043901.  06/27/07  Chen

This document summarizes human exposure incidents from exposure to
glutaraldehyde.  It also includes revisions based on the registrants
(The Dow Chemical Company and BASF Corporation) Phase1 error correction
comments.

Docket Item 17. 	Letter from Dow; Error Correction Response
Glutaraldehyde Draft Risk Assessment Reregistration Eligibility Decision
(RED), Case 2315. 06/16/06  Mikstal

This correspondence describes potential errors in the glutaraldehyde
draft risk assessment identified by the registrant (The Dow Chemical
Company) for Phase 1 error correction. 

Docket Item 18. 	Dow’s Comments on Glutaraldehyde: Antimicrobials
Division’s Risk Assessment for Issuance of the Reregistration
Eligibility Decision (RED) Document. 06/16/06  Mikstal

This document shows the registrant’s (The Dow Chemical Company) Phase
1 comments on the glutaraldehyde draft risk assessment.

Docket Item 19. 	Letter from BASF; BASF Corporation 30-Day Correcion
Response to EPA Draft Reregistration Eligibility Decision for
Glutaraldehyde.  06/16/06.  Crescenzi

This correspondence describes potential errors in the Glutaraldehyde
Draft Risk Assessment identified by the registrant (BASF Corporation)
for Phase 1 error correction. 

Docket Item 20. 	BASF’s Comments on Glutaraldehyde: Antimicrobials
Division’s Risk Assessment for Issuance of the Reregistration
Eligibility Decision (RED) Document.  06/16/06  Mikstal

This document shows the registrant’s (BASF Corporation) Phase 1
comments on the glutaraldehyde draft risk assessment.

Docket Item 21. 	Glutaraldehyde: Report of the Cancer Assessment Review
Committee.  05/18/06.  Kidwell

This document describes the decision on the carcinogenic potential of
glutaraldehyde, including the factors and uncertainties that were
considered.

