> United States Prevention, Pesticides EPA738-R-05-001

Environmental Protection and Toxic Substances January 2005

Agency (7508C)![](media/image1.wmf){width="1.4194444444444445in"
height="0.4986111111111111in"}

> Reregistration

Eligibility Decision

for Para-Tertiary-

> Amylphenol, Potassium Sodium Salt (Case 3016)

**UNITED STATES ENVIRONMENTAL PROTECTION AGENCY**

WASHINGTON, D.C. 20460

> OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

**[CERTIFIED MAIL]{.underline}**

Dear Registrant:

This is to inform you that the Environmental Protection Agency
(hereafter referred to as EPA or the Agency) has completed its review of
the available data and public comments received related to the
preliminary risk assessments for the antimicrobial, Para-Tertiary-
amylphenol (4-t-amylphenol). The enclosed Reregistration Eligibility
Decision (RED) document was approved on September 30, 2005. Public
comments and additional data received were considered in this decision.

Based on its review, EPA is now publishing its Reregistration
Eligibility Decision (RED) and risk management decision for
4-t-amylphenol and its associated human health and environmental risks.
A Notice of Availability will be published in the *Federal Register*
announcing the publication of the RED.

The RED and supporting risk assessments for 4-t-amylphenol are available
to the public in EPA's Pesticide Docket **OPP-2005-0181** at:
<http://www.epa.gov/edockets>.

The 4-t-amylphenol RED was developed through EPA's public participation
process, published in the Federal Register on July 20, 2005, which
provides opportunities for public involvement in the Agency's pesticide
tolerance reassessment and reregistration programs. Developed in
partnership with USDA and with input from EPA's advisory committees and
others, the public participation process encourages robust public
involvement starting early and continuing throughout the pesticide risk
assessment and risk mitigation decision making process. The public
participation process encompasses full, modified, and streamlined
versions that enable the Agency to tailor the level of review to the
level of refinement of the risk assessments, as well as to the amount of
use, risk, public concern, and complexity associated with each
pesticide. Using the public participation process, EPA is attaining its
strong commitment to both involve the public and meet statutory
deadlines.

Please note that the 4-t-amylphenol risk assessment and the attached RED
document concern only this particular pesticide. This RED presents the
Agency's conclusions on the dietary, drinking water, occupational and
ecological risks posed by exposure to 4-t-amylphenol alone. This
document also contains both generic and product-specific data that the
Agency intends to require in Data Call-Ins (DCIs). Note that DCIs, with
all pertinent instructions, will be sent to registrants at a later date.
Additionally, for product-specific DCIs, the first set of required
responses will be due 90 days from the receipt of the DCI letter. The
second set of required responses will be due eight months from the
receipt of the DCI letter.

As part of the RED, the Agency has determined that 4-t-amylphenol will
be eligible for reregistration provided that all the conditions
identified in this document are satisfied, including implementation of
the risk mitigation measures outlined in Section IV of the document.
Sections IV and V of this RED document describe labeling amendments for
end-use products and data requirements necessary to implement these
mitigation measures. Instructions for registrants on submitting the
revised labeling can be found in the set of instructions for
product-specific data that accompanies this document.

Should a registrant fail to implement any of the risk mitigation
measures outlined in this document, the Agency will continue to have
concerns about the risks posed by 4-t-amylphenol. Where the Agency has
identified any unreasonable adverse effect to human health and the
environment, the Agency may at any time initiate appropriate regulatory
action to address this concern. At that time, any affected person(s) may
challenge the Agency's action.

If you have questions on this document or the label changes necessary
for reregistration, please contact the Chemical Review Manager, Killian
Swift, at (703) 308-6346. For questions about product reregistration
and/or the Product DCI that accompanies this document, please contact
Adam Heyward at (703) 308-6422.

Sincerely,

Frank Sanders, Director

Antimicrobials Division (7510C)

> **REREGISTRATION ELIGIBILITY**
>
> **DECISION**
>
> **for**
>
> **Para-tertiary-amylphenol**
>
> List C
>
> CASE 3016

Approved By:

Frank Sanders

Director, Antimicrobials Division

Date: September 30, 2005

> Attachment

**Table of Contents**

+------------------------------------------------------------------+---+
| **Glossary of Terms and                                          | * |
| Abbr                                                             | * |
| eviations.....................................................** | x |
|                                                                  | v |
|                                                                  | i |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **4-t-amylphenol Reregistration                                  | * |
| Team.......................................................**    | * |
|                                                                  | x |
|                                                                  | i |
|                                                                  | v |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **Executive                                                      | * |
| Summary...............                                           | * |
| .........................................................\....** | x |
|                                                                  | v |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
|                                                                  |   |
+------------------------------------------------------------------+---+
| **I.                                                             | * |
| Introduction.....................                                | * |
| ..............................................................** | 1 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **II. Chemical                                                   | * |
| Overview......                                                   | * |
| ................................................................ | 3 |
| ..**                                                             | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **A. Regulatory                                                  | * |
| History                                                          | * |
| ..............................................................** | 3 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **B. Chemical Identification                                     | * |
| ........................................................**       | * |
|                                                                  | 3 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **C. Use                                                         | * |
| Profile..............                                            | * |
| ..........................................................\...** | 4 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **III. Summary of 4-t-amylphenol Risk                            | * |
| Assessments.....................................**               | * |
|                                                                  | 6 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **A. Human Health Risk                                           | * |
| Assessment.............................................**        | * |
|                                                                  | 6 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **1. Toxicity of                                                 | * |
| 4-t-amylphenol...........................................**      | * |
|                                                                  | 6 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **2. FQPA Safety                                                 | * |
| .                                                                | * |
| ..............................................................** | 8 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **3. Population Adjusted Dose                                    | * |
| (PAD)....................................\...**                  | * |
|                                                                  | 9 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **a. Acute                                                       | * |
| PAD.........................................................**   | * |
|                                                                  | 9 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **b. Chronic                                                     | * |
| PAD...................................................**         | * |
|                                                                  | 9 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **4. Exposure                                                    | * |
| Assumptions...................................................** | * |
|                                                                  | 1 |
|                                                                  | 0 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **5. Dietary (Food) Risk                                         | * |
| Assessment........................................**             | * |
|                                                                  | 1 |
|                                                                  | 0 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **a. Acute Dietary                                               | * |
| Risk...............................................**            | * |
|                                                                  | 1 |
|                                                                  | 0 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **b. Chronic (Non-Cancer) Dietary                                | * |
| Risk..........................**                                 | * |
|                                                                  | 1 |
|                                                                  | 0 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **c. Dietary Risks from Drinking                                 | * |
| Water..........................**                                | * |
|                                                                  | 1 |
|                                                                  | 1 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **6. Residential                                                 | * |
| E                                                                | * |
| xposure\......................................................** | 1 |
|                                                                  | 1 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **a.                                                             | * |
| Toxicit                                                          | * |
| y.............................................................** | 1 |
|                                                                  | 2 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **b. Residential                                                 | * |
| Handler...\............................................**        | * |
|                                                                  | 1 |
|                                                                  | 3 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| > **i. Exposure Scenarios, Data and Assumptions........**        | * |
|                                                                  | * |
|                                                                  | 1 |
|                                                                  | 3 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| > **ii. Residential Handler Risk Estimates.................**    | * |
|                                                                  | * |
|                                                                  | 1 |
|                                                                  | 4 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **c. Residential Post-application                                | * |
| ...................................**                            | * |
|                                                                  | 1 |
|                                                                  | 4 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| > **i. Exposure Scenarios, Data and Assumptions........**        | * |
|                                                                  | * |
|                                                                  | 1 |
|                                                                  | 4 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| > **ii. Residential Post-Application Risk Estimates....**        | * |
|                                                                  | * |
|                                                                  | 1 |
|                                                                  | 5 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **7. Aggregate                                                   | * |
| Ri                                                               | * |
| sk............................................................** | 1 |
|                                                                  | 6 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **a. Short and Intermediate Term Aggregate Risk \............**  | * |
|                                                                  | * |
|                                                                  | 1 |
|                                                                  | 7 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **b. Long Term Aggregate                                         | * |
| Risk...................................**                        | * |
|                                                                  | 1 |
|                                                                  | 8 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **8. Occupational                                                | * |
| Risk......................................................\...** | * |
|                                                                  | 1 |
|                                                                  | 8 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **a. Occupational                                                | * |
| Toxicity...........................................**            | * |
|                                                                  | 1 |
|                                                                  | 9 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **b. Occupational Handler                                        | * |
| Exposure..............................**                         | * |
|                                                                  | 1 |
|                                                                  | 9 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **c. Occupational Handler Risk                                   | * |
| Summary.....................\...**                               | * |
|                                                                  | 1 |
|                                                                  | 9 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **d. Occupational Post-Application Risk Summary............**    | * |
|                                                                  | * |
|                                                                  | 2 |
|                                                                  | 1 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **e. Human Incident                                              | * |
| Data............................................**               | * |
|                                                                  | 2 |
|                                                                  | 1 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **B. Environmental Risk                                          | * |
| Assessment...............................................**      | * |
|                                                                  | 2 |
|                                                                  | 1 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **1. Environmental Fate and                                      | * |
| Transport.................................\...**                 | * |
|                                                                  | 2 |
|                                                                  | 1 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **2. Ecological                                                  | * |
| Ri                                                               | * |
| sk............................................................** | 2 |
|                                                                  | 2 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **3. Endocrine Effects in                                        | * |
| Fish................................................**           | * |
|                                                                  | 2 |
|                                                                  | 3 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **4. Listed Species Consideration                                | * |
| ...........................................**                    | * |
|                                                                  | 2 |
|                                                                  | 4 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **a. The Endangered Species                                      | * |
| Act...................................**                         | * |
|                                                                  | 2 |
|                                                                  | 4 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **b. General Risk                                                | * |
| Mitigation......................................**               | * |
|                                                                  | 2 |
|                                                                  | 5 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **IV. Risk Management, Reregistration, and Tolerance             | * |
| Reassessment Decision...**                                       | * |
|                                                                  | 2 |
|                                                                  | 6 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **A. Determination of Reregistration                             | * |
| Eligibility.................................**                   | * |
|                                                                  | 2 |
|                                                                  | 6 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **B. Public Comments and                                         | * |
| Responses..............................................**        | * |
|                                                                  | 2 |
|                                                                  | 6 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **C. Regulatory                                                  | * |
| Position.                                                        | * |
| ..............................................................** | 2 |
|                                                                  | 7 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **1. Food Quality Protection Act                                 | * |
| Considerations.....................\...**                        | * |
|                                                                  | 2 |
|                                                                  | 7 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **a. \"Risk Cup\"                                                | * |
| Determination.....................................**             | * |
|                                                                  | 2 |
|                                                                  | 7 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **b. Determination of Safety to U.S.                             | * |
| Population................**                                     | * |
|                                                                  | 2 |
|                                                                  | 7 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **c. Determination of Safety to Infants and Children.........**  | * |
|                                                                  | * |
|                                                                  | 2 |
|                                                                  | 8 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **d. Endocrine Disruptor                                         | * |
| Effects...................................**                     | * |
|                                                                  | 2 |
|                                                                  | 8 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **e. Cumulative                                                  | * |
| Risks.................................................**         | * |
|                                                                  | 2 |
|                                                                  | 9 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **2. Tolerance                                                   | * |
| Summary...................................................**     | * |
|                                                                  | 2 |
|                                                                  | 9 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **a. Tolerances Currently Listed and Tolerance                   | * |
| Reassessment................................................**   | * |
|                                                                  | 2 |
|                                                                  | 9 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **b. Codex                                                       | * |
| Harmonization..........................................**        | * |
|                                                                  | 3 |
|                                                                  | 0 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **D. Regulatory                                                  | * |
| Rationale                                                        | * |
| ..............................................................** | 3 |
|                                                                  | 0 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **1. Human Health Risk                                           | * |
| Management.....................................**                | * |
|                                                                  | 3 |
|                                                                  | 0 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **a. Dietary (Food) Risk                                         | * |
| Mitigation...............................**                      | * |
|                                                                  | 3 |
|                                                                  | 0 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **b. Drinking Water Risk                                         | * |
| Mitigation.............................**                        | * |
|                                                                  | 3 |
|                                                                  | 0 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **c. Residential Risk                                            | * |
| Mitigation....................................**                 | * |
|                                                                  | 3 |
|                                                                  | 0 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **d. Occupational Risk                                           | * |
| Mitigation.................................**                    | * |
|                                                                  | 3 |
|                                                                  | 1 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **i. Handler Exposure........................................**  | * |
|                                                                  | * |
|                                                                  | 3 |
|                                                                  | 1 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **ii. Post-Application Risk Mitigation...................**      | * |
|                                                                  | * |
|                                                                  | 3 |
|                                                                  | 1 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **2. Environmental Risk                                          | * |
| Management................................**                     | * |
|                                                                  | 3 |
|                                                                  | 1 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **3. Other Labeling                                              | * |
| Requirements..........................................**         | * |
|                                                                  | 3 |
|                                                                  | 1 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **4. Threatened and Endangered Species                           | * |
| Considerations..............**                                   | * |
|                                                                  | 3 |
|                                                                  | 2 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **a. The Endangered Species                                      | * |
| Program............................**                            | * |
|                                                                  | 3 |
|                                                                  | 2 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **b. General Risk                                                | * |
| Mitigation......................................**               | * |
|                                                                  | 3 |
|                                                                  | 2 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **V. What Registrants Need to                                    | * |
| Do...........................................................**  | * |
|                                                                  | 3 |
|                                                                  | 4 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **A. Manufacturing                                               | * |
| U                                                                | * |
| se-Products...................................................** | 3 |
|                                                                  | 6 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **1. Additional Generic Data                                     | * |
| Requirements.............................**                      | * |
|                                                                  | 3 |
|                                                                  | 6 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **2. Labeling for Technical and Manufacturing-Use                | * |
| Products........**                                               | * |
|                                                                  | 3 |
|                                                                  | 8 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **B. End-Use                                                     | * |
| Products                                                         | * |
| ..............................................................** | 3 |
|                                                                  | 8 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **1. Additional Product Specific Data                            | * |
| Requirements............\...\...\....**                          | * |
|                                                                  | 3 |
|                                                                  | 8 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **2. Labeling for End-Use                                        | * |
| Products.........................................**              | * |
|                                                                  | 3 |
|                                                                  | 8 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **a. Label Changes Summary                                       | * |
| Table...............................**                           | * |
|                                                                  | 3 |
|                                                                  | 9 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **VI.                                                            | * |
| Appendices....................                                   | * |
| ..............................................................** | 4 |
|                                                                  | 1 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **A. Table of Use Patterns for                                   | * |
| 4-t-amylphenol....................................**             | * |
|                                                                  | 4 |
|                                                                  | 3 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **B. Table of Generic Data Requirements and Studies Use to Make  | * |
| the Reregistration                                               | * |
| Decision....................................................**   | 6 |
|                                                                  | 8 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **C. Technical Support                                           | * |
| Documents................................................**      | * |
|                                                                  | 7 |
|                                                                  | 3 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **D. Bibliography                                                | * |
| Citat                                                            | * |
| ions..........................................................** | 7 |
|                                                                  | 4 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **E. Generic Data                                                | * |
| Call-I                                                           | * |
| n.............................................................** | 7 |
|                                                                  | 9 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **F. Product Specific Data                                       | * |
| Call-In...................................................**     | * |
|                                                                  | 8 |
|                                                                  | 0 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **G. Batching of End-Use                                         | * |
| Products.................................................**      | * |
|                                                                  | 8 |
|                                                                  | 1 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **H. List of All Registrants Sent the Data                       | * |
| Call-In................................**                        | * |
|                                                                  | 8 |
|                                                                  | 3 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
| **I. List of Available                                           | * |
| Fo                                                               | * |
| rms...........................................................** | 8 |
|                                                                  | 4 |
|                                                                  | * |
|                                                                  | * |
+------------------------------------------------------------------+---+
|                                                                  |   |
+------------------------------------------------------------------+---+
|                                                                  |   |
+------------------------------------------------------------------+---+

# Glossary of Terms and Abbreviations

a.i. Active Ingredient

aPAD Acute Population Adjusted Dose

APHIS Animal and Plant Health Inspection Service

ARTF Agricultural Re-entry Task Force

BCF Bioconcentration Factor

CDC Centers for Disease Control

CDPR California Department of Pesticide Regulation

CFR Code of Federal Regulations

ChEI Cholinesterase Inhibition

CMBS Carbamate Market Basket Survey

cPAD Chronic Population Adjusted Dose

CSFII USDA Continuing Surveys for Food Intake by Individuals

CWS Community Water System

DCI Data Call-In

DEEM Dietary Exposure Evaluation Model

DL Double layer clothing {i.e., coveralls over SL}

DWLOC Drinking Water Level of Comparison

EC Emulsifiable Concentrate Formulation

EDSP Endocrine Disruptor Screening Program

EDSTAC Endocrine Disruptor Screening and Testing Advisory Committee

EEC Estimated Environmental Concentration. The estimated pesticide
concentration in an environment, such as a terrestrial ecosystem.

EP End-Use Product

EPA U.S. Environmental Protection Agency

EXAMS Tier II Surface Water Computer Model

FDA Food and Drug Administration

FFDCA Federal Food, Drug, and Cosmetic Act

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FOB Functional Observation Battery

FQPA Food Quality Protection Act

FR Federal Register

GL With gloves

GPS Global Positioning System

HIARC Hazard Identification Assessment Review Committee

IDFS Incident Data System

IGR Insect Growth Regulator

IPM Integrated Pest Management

RED Reregistration Eligibility Decision

LADD Lifetime Average Daily Dose

LC~50~ Median Lethal Concentration. Statistically derived concentration
of a substance expected to cause death in 50% of test animals, usually
expressed as the weight of substance per weight or volume of water, air
or feed, e.g., mg/l, mg/kg or ppm.

LCO Lawn Care Operator

LD~50~ Median Lethal Dose. Statistically derived single dose causing
death in 50% of the test animals when administered by the route
indicated (oral, dermal, inhalation), expressed as a weight of substance
per unit weight of animal, e.g., mg/kg.

LOAEC Lowest Observed Adverse Effect Concentration

LOAEL Lowest Observed Adverse Effect Level

LOC Level of Concern

LOEC Lowest Observed Effect Concentration

mg/kg/day Milligram Per Kilogram Per Day

MOE Margin of Exposure

MP Manufacturing-Use Product

MRID Master Record Identification (number). EPA's system of recording
and tracking studies submitted.

MRL Maximum Residue Level

N/A Not Applicable

NASS National Agricultural Statistical Service

NAWQA USGS National Water Quality Assessment

NG No Gloves

NMFS National Marine Fisheries Service

NOAEC No Observed Adverse Effect Concentration

NOAEL No Observed Adverse Effect Level

NPIC National Pesticide Information Center

NR No respirator

OP Organophosphorus

OPP EPA Office of Pesticide Programs

ORETF Outdoor Residential Exposure Task Force

PAD Population Adjusted Dose

PCA Percent Crop Area

PDCI Product Specific Data Call-In

PDP USDA Pesticide Data Program

PF10 Protections factor 10 respirator

PF5 Protection factor 5 respirator

PHED Pesticide Handler's Exposure Data

PHI Pre-harvest Interval

Ppb Parts per Billion

PCCs Poison Control Centers

PPE Personal Protective Equipment

PRZM Pesticide Root Zone Model

RBC Red Blood Cell

RED Reregistration Eligibility Decision

REI Restricted Entry Interval

RfD Reference Dose

RPA Reasonable and Prudent Alternatives

RPM Reasonable and Prudent Measures

RQ Risk Quotient

RTU (Ready-to-use)

RUP Restricted Use Pesticide

SCI-GROW Tier I Ground Water Computer Model

SF Safety Factor

SL Single layer clothing

SLN Special Local Need (Registrations Under Section 24C of FIFRA)

STORET Storage and Retrieval

TEP Typical End-Use Product

TGAI Technical Grade Active Ingredient

TRAC Tolerance Reassessment Advisory Committee

TTRS Transferable Turf Residues

UF Uncertainty Factor

USDA United States Department of Agriculture

USFWS United States Fish and Wildlife Service

USGS United States Geological Survey

WPS Worker Protection Standard

#  4Para-Tertiary-Amylphenol Reregistration Team

**[Office of Pesticide Programs]{.underline}**

**[Environmental Fate and Effects Risk Assessment]{.underline}**

**Srinivas Gowda**

**David Bays**

**[Health Effects Risk Assessment]{.underline}**

**Jonathan Chen**

**Timothy Leighton**

**Tim McMahon**

**Siroos Mostaghimi**

**Myron Ottley**

**Bob Quick**

**Najm Shamim**

**Deborah Smegal**

**Cassi Walls**

**[Registration Support]{.underline}**

**Adam Heyward**

**[Risk Management]{.underline}**

**Ben Chambliss**

**Killian Swift**

**ShaRon Carlisle**

# Executive Summary 

The Environmental Protection Agency (hereafter referred to as EPA or the
Agency) has completed its review of public comments on the human health
and environmental risk assessments for para-tertiary-amylphenol
(4-t-amylphenol) and its potassium and sodium salt and is issuing its
risk management decision. The Agency has determined 4-t-amylphenol and
its potassium and sodium salts are eligible for reregistration provided
all measures outlined in this document are implemented. 4-t-Amylphenol
is a member of the phenolic class of antimicrobials. 4-t-Amylphenol is
an active ingredient in disinfectant, food-contact sanitizer and
deodorizer products used in agricultural, food handling, commercial,
institutional, industrial, residential, public access, and medical
settings, primarily on hard, non-porous surfaces. The majority of the
products are virucidal, fungicidal, tuberculocidal or bactericidal.
Examples of registered uses for 4-t-amylphenol include application to
hard surfaces (e.g., walls, floors, tables, fixtures), textiles (e.g.,
clothing, diapers, mattresses, bedding), carpets, medical instruments,
and agricultural equipment. Additionally, there are registered uses for
fogging in occupational settings and air deodorization in both
occupational and residential settings.

**Overall Risk Summary**

The Agency's human heath risk assessment indicates no risks of concern
for dietary or drinking water exposures. An acute dietary risk estimate
was completed for females 13-49 years old, the only population subgroup
with an acute toxicity endpoint, and is below the Agency's level of
concern. Chronic dietary risk estimates were provided for the general
U.S. population and all population subgroups. All chronic dietary risk
estimates are below the Agency's level of concern.

4-t-Amylphenol and its salts are not likely to contaminate surface and
ground waters based on its use patterns and fate characteristics. Thus,
a drinking water assessment was not conducted. Therefore, no risk
mitigation measures are required to address 4-t-amylphenol exposure from
drinking water.

Residential risks from handler and post-application exposure were
calculated for short- and intermediate-term dermal, inhalation and
incidental oral exposures. All exposure and risk estimates for
residential handler scenarios are below the Agency's level of concern.
Risks of concern have been identified for several post-application
exposure scenarios including children's dermal exposure to treated
clothing and treated diapers and children's incidental oral exposure to
treated clothing. The Agency believes that adding clear instructions for
washing and rinsing textile items will result in the adequate removal of
residues from the treated items and address the Agency's concerns for
this scenario. The MOE for dermal exposure to children to treated
surfaces in daycare centers slightly exceeds the Agency's level of
concern (MOE = 940 with a target MOE of 1,000). However, the Agency
believes actual exposure from this pathway to not exceed its level of
concern when taking into account the conservative nature of the risk
estimate which is likely to overestimate potential exposures.

Aggregate short and intermediate term risk assessments were conducted
for this chemical that includes incidental oral and inhalation risks
only. Dermal risks are not included in the aggregate risk estimates
because they have a different toxicity endpoint. The aggregate oral and
inhalation risks are not of concern for adults, as the total aggregate
MOE is greater than the target of 3,000. For children, the aggregate
risk estimates are also above the target MOE of 3,000 and thus are not
of concern. However, incidental oral exposures to treated textiles are
not included in the aggregate assessment because the oral MOE is already
of concern.

For the occupational handler dermal and inhalation risk assessment, the
short- and intermediate- term risks calculated at baseline exposure (no
gloves and no respirators) were above target MOEs for all scenarios. For
most of the occupational scenarios, postapplication dermal exposure is
not expected to occur or is expected to be negligible based on the
application rates and chemical properties of the chemical.
Postapplication/bystander inhalation exposures, however, were assessed
for entry into a building after a fogging application. The
representative building selected was a poultry barn. The calculated
inhalation MOEs were above the target MOE of 300 for all fogging
postapplication scenarios with the exception of the scenario for 8-hr
exposure to the product with a 2-hr reentry interval (MOE = 86).

There is a concern about the possibility of endocrine disruption in
fish, since 4-t-amylphenol is considered an ecoestrogen. However, since
this chemical is restricted to indoor uses only, the possibility for
exposure to fish to 4-t-amylphenol would be limited. The limited
exposure resulting from indoor uses of 4-t-amylphenol and its salts is
not anticipated to cause adverse effects to terrestrial or aquatic
organisms.

[Dietary Exposure Risk]{.underline}

An acute dietary risk assessment was conducted for 4-t-amylphenol
indirect food uses. Dietary risk estimates are provided for females
13-49 years old, the only population subgroup for which an endpoint was
selected. The result of this assessment showed the risk estimate to be
2.7% of the aPAD and therefore is not of concern

A chronic dietary risk assessment was conducted for 4-t-amylphenol food
uses. The risk analysis assumes daily exposure from the hard surface
disinfection of counter tops. The result of this assessment showed the
risk estimates to be \<42% of the cPAD and therefore are not of concern.

[Drinking Water Risk]{.underline}

4-t-Amylphenol and its salts are not likely to contaminate surface and
ground waters based on its use patterns and fate characteristics. There
are no currently registered outdoor uses of 4-t-amylphenol and its
salts. Further, the estimated value for biodegradation indicates it may
biodegrade linearly within days in the aquatic environment, although
ultimate biodegradation (mineralization) may take months. It also is
volatile based on its vapor pressure of 0.00116 mmHg, and has a moderate
to slight mobility in soils based on its estimated Koc value of 3799.
The sodium and potassium salts of 4-t-amylphenol also are slightly to
moderately mobile in soils, and are estimated to biodegrade within days
to weeks. Because of the possibility of biodegradation in water and
soils and the lack of outdoor uses, 4-t-amylphenol and its salts are not
likely to contaminate surface and ground waters. Thus, a drinking water
assessment was not conducted.

[Residential Handler Risk]{.underline}

For residential handlers that handle products containing 4-t-amylphenol
and its salts, short-term, and intermediate-term MOEs were above the
target MOEs (i.e., \>1,000 for dermal and \>3,000 for inhalation) for
all scenarios evaluated and thus, do not exceed the Agency's level of
concern.

[Residential Post-Application Risk]{.underline}

Risks of concern have been identified for several post-application
exposure scenarios including children's dermal exposure to treated
clothing and treated diapers and children's incidental oral exposure to
treated clothing. The Agency believes that adding clear instructions for
washing and rinsing textile items will result in the adequate removal of
residues from the treated items and address the Agency's concerns for
this scenario. The MOE for dermal exposure to children to treated
surfaces in daycare centers slightly exceeds the Agency's level of
concern (MOE = 940 with a target MOE of 1,000). However, the Agency
believes actual exposure from this pathway to not exceed its level of
concern when taking into account the conservative nature of the risk
estimate which is likely to overestimate potential exposures.

[Aggregate Risk]{.underline}

Short- and intermediate-term aggregate risks are considered together
because the exposure and toxicity endpoints are identical for incidental
oral and inhalation residential exposures for both durations. For
children, the short- and intermediate-term aggregate assessment includes
average dietary exposure (food) and estimated incidental oral exposures
to children from residential uses such as hard surface disinfection. In
addition, inhalation exposure from post-application of an air deodorizer
use was aggregated with the oral exposures since the toxicity endpoint
is the same. For adults, the aggregate assessment includes dietary
(oral) and residential inhalation exposures from wiping a hard surface
disinfectant, in addition to post application inhalation exposure from
the air deodorizer.

Aggregate oral and inhalation risks are not of concern for adults, as
the total aggregate MOE is greater than the target of 3,000. For
children, the aggregate risk estimates are also above the target MOE of
3,000 and thus are not of concern. As noted previously, incidental oral
exposures to treated textiles are not included in the aggregate
assessment because the oral MOE is already of concern.

A dermal aggregate assessment was not conducted because the toxicity
effects for the dermal exposure route are not the same as the
oral/inhalation exposure route. However, short- and intermediate dermal
risks are already of concern for residents for the treated textile and
diaper use.

[Occupational Risk]{.underline}

To assess the handler risks, the Agency used surrogate unit exposure
data from both the proprietary Chemical Manufacturers (CMA)
antimicrobial exposure study and the Pesticide Handlers Exposure
Database (PHED). For the occupational handler dermal and inhalation risk
assessment, the short- and intermediate-term risks calculated at
baseline exposure (no gloves and no respirators) were above target MOEs
for all scenarios (i.e., dermal MOEs \> 100 and inhalation MOEs were
\>300). Note, however, that high pressure spray application method in
the agricultural use site category was assessed using gloved data.

For most of the occupational scenarios, post-application dermal exposure
is not expected to occur and it is expected to be negligible based on
the application rates and chemical properties of the chemical. However,
post-application/bystander inhalation exposures were assessed for entry
into a building after fogging application. The representative building
selected was a poultry barn. The Agency used MCCEM (Multi-Chamber
Concentration and Exposure Model) to estimate post-application/bystander
exposures. The calculated inhalation MOEs were above the target MOE of
300 for all fogging post-application scenarios with the exception of the
scenario for 8-hour exposure to the product with a 2-hour re-entry
interval (MOE = 86).

The Agency does not believe that any mitigation is necessary to address
the post-application scenario with a 2-hr reentry interval at this time.
The risk estimate was calculated using the Agency's standard assumptions
for air exchange rates. The Agency believes that in the case of animal
barns and facilities this assumption in very conservative given the
relatively high air exchange rates for such facilities.

[Ecological Risk]{.underline}

There is a concern about the possibility of endocrine disruption in
fish, since 4-t-amylphenol is considered an ecoestrogen. This was
documented in several studies on carp (*Cyprimus carpio)*. However,
since this chemical is restricted to indoor uses only, the possibility
for exposure to fish to 4-t-amylphenol would be limited. The limited
exposure resulting from indoor uses of 4-t-amylphenol and its salts is
not anticipated to cause adverse effects to terrestrial or aquatic
organisms.

[Regulatory Decision]{.underline}

The Agency has completed its review and has determined that the data are
sufficient to support reregistration of all supported products
containing 4-t-amylphenol. The Agency is issuing this RED for
4-t-amylphenol, as announced in a Notice of Availability published in
the *Federal Register*. This RED document includes guidance and time
frames for making any necessary label changes for products containing
4-t-amylphenol.

[Summary of Mitigation Measures]{.underline}

The Agency has determined that 4-t-amylphenol and its salts (potassium
and sodium) are eligible for reregistration provided the mitigation
measures described in this document and the label changes included in
Table 13 in Section V of the RED are implemented.

*Residential Risk Mitigation*

To reduce residential exposure, the Agency has determined that the
following mitigation and label changes for specific scenarios are
appropriate and required for reregistration eligibility:

-   Delete all diaper uses

-   Delete all use on non-laundered textiles\\items including
    mattresses, helmets, headgear, headphones, facegear, and
    mouthpieces.

-   All labels with laundered textile uses must have directions that
    indicate that items must be treated prior to washing and rinsing.

    **I. Introduction**

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended in 1988 to accelerate the reregistration of products with active
ingredients registered prior to November 1, 1984 and amended again by
the Pesticide Registration Improvement Act of 2003 to set time frames
for the issuance of Reregistration Eligibility Decisions. The amended
Act calls for the development and submission of data to support the
reregistration of an active ingredient, as well as a review of all
submitted data by the U.S. Environmental Protection Agency (EPA or the
Agency). Reregistration involves a thorough review of the scientific
database underlying a pesticide's registration. The purpose of the
Agency's review is to reassess the potential hazards arising from the
currently registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to determine
whether or not the pesticide meets the "no unreasonable adverse effects"
criteria of FIFRA.

On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was
signed into law. This Act amends FIFRA to require tolerance
reassessment. The Agency has decided that, for those chemicals that have
tolerances and are undergoing reregistration, the tolerance reassessment
will be initiated through this reregistration process. The Act also
requires that by 2006, EPA must review all tolerances in effect on the
day before the date of the enactment of the FQPA. FQPA also amends the
Federal Food, Drug, and Cosmetic Act (FFDCA) to require a safety finding
in tolerance reassessment based on factors including consideration of
cumulative effects of chemicals with a common mechanism of toxicity.
This document presents the Agency's revised human health and ecological
risk assessments; and the Reregistration Eligibility Decision (RED) for
4-tertiary-amylphenol (4-t-amylphenol), and salts (potassium and
sodium).

4-t-Amylphenol and salts are active ingredients in disinfectant and
food-contact sanitizer products used in agricultural, food handling,
commercial/institutional/industrial, residential, public access, and
medical settings -- primarily on hard, non-porous surfaces. The majority
of the products are virucidal, fungicidal, bactericidal,
pseudomonacidal, or staphylocidal. Examples of registered uses for
4-t-amylphenol and salts include application to hard surfaces (e.g.,
walls, floors, tables, and fixtures), textiles (e.g., clothing, diapers,
mattresses, and bedding), carpets, medical instruments, and agricultural
equipment. Additionally, there are registered uses for fogging in
occupational settings and air deodorization in both occupational and
residential settings. Concentrations of 4-t-amylphenol and salts in
products range from 0.0027% to 10%. The products are formulated as
soluble concentrates, ready-to-use liquid solutions, pressurized sprays,
and impregnated wipes.

The Agency has concluded that the hazard based FQPA safety factor should
be retained at 10X**.** The toxicology data base is not complete with
respect to assessing the increased susceptibility to infants and
children as required by FQPA for 4-t-amylphenol. The rat prenatal
developmental study showed no quantitative evidence of increased
susceptibility (i.e., developmental NOAELs /LOAELs were higher than
those for maternal effects). However, there was qualitative evidence of
increased susceptibility as the fetal effects (i.e., skeletal
abnormalities, decreased body weight gain) were considered to be more
severe than maternal toxicity (reversible clinical signs). In addition,
there is an absence of developmental toxicity data in the rabbit, and an
absence of reproductive toxicity data. Furthermore, studies in the open
literature suggest that 4-t-amylphenol may be an endocrine disruptor. It
increased non-pregnant uterine weight in rats and was associated with
elevated blood levels of billirubin in children exposed to
4-t-amylphenol and other phenols in disinfectants. These studies, while
not indicative, are suggestive of a basis for increased concern for
reproductive and/or developmental effects due to exposure to
4-t-amylphenol.

Risks summarized in this document are those that result only from the
use of the active ingredients 4-t-amyphenol and its salts (potassium and
sodium). The Food Quality Protection Act (FQPA) requires that the Agency
consider available information concerning the cumulative effects of a
particular pesticide's residues and other substances that have a common
mechanism of toxicity. The reason for consideration of other substances
is due to the possibility that low-level exposures to multiple chemical
substances that cause a common toxic effect by a common toxic mechanism
could lead to the same adverse health effect that would occur at a
higher level of exposure to any of the substances individually. Unlike
other pesticides for which EPA has followed a cumulative risk approach
based on a common mechanism of toxicity, EPA has not made a common
mechanism of toxicity finding for 4-t-amyphenol and its salts (potassium
and sodium) and any other substances. 4-t-Amyphenol and it salts
(potassium and sodium) do not appear to produce a toxic metabolite
produced by other substances. For the purposes of this action,
therefore, EPA has not assumed that 4-t-amyphenol and it salts
(potassium and sodium) has a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the policy statements released
by EPA's Office of Pesticide Programs concerning common mechanism
determinations and procedures for cumulating effects from substances
found to have a common mechanism on EPA's website at
<http://www.epa.gov/pesticides/cumulative> .

This document presents the Agency's decision regarding the
reregistration eligibility of the registered uses of 4-t-amyphenol and
its salts (potassium and sodium). In an effort to simplify the RED, the
information presented herein is summarized from more detailed
information which can be found in the technical supporting documents for
4-t-amylphenol and salts referenced in this RED. The revised risk
assessments and related addenda are not included in this document, but
are available in the Public Docket at <http://www.epa.gov/edocket>
(OPP-2005-0181)

This document consists of six sections. Section I is the introduction.
Section II provides a chemical overview, a profile of the use and usage
of 4-t-amylphenol and its salt (potassium and sodium), and its
regulatory history. Section III, Summary of 4-t-amylphenol and salts
Risk Assessment, gives an overview of the human health and environmental
assessments, based on the data available to the Agency. Section IV, Risk
Management, Reregistration, and Tolerance Reassessment Decision,
presents the reregistration eligibility and risk management decisions.
Section V, What Registrants Need to Do, summarizes the necessary label
changes based on the risk mitigation measures outlined in Section IV.
Finally, the Appendices list all use patterns eligible for
reregistration, bibliographic information, related documents and how to
access them, and Data Call-In (DCI) information.

**II. Chemical Overview**

## A. Regulatory History

4-t-Amyphenol and its salts (potassium and sodium) have been registered
for use since 1962. Currently, there are 35 products containing
4-t-amyphenol (one technical product and 34 end-use-products) registered
under Section 3 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA).

## Chemical Identification 

1.  **Para-Tertiary-Amylphenol & its Potassium and Sodium Salts**

![](media/image2.wmf)

![](media/image3.wmf)

**Common name:** Para-Tertiary amylphenol

> **Chemical name:** 4-tertiary-amylphenol, and salts

**Chemical Family:** Antimicrobial Disinfectant

**Empirical formula:** C5H11C6H4OH (064101) C5H11C6H4Na+ (064111)

C5H11C6H4K+ (064112)

**CAS Registry No.:** 064101: 80-46-6 (4-t-amylphenol)

064111: 53404-18-5 (sodium salt)

064112: 31366-95-7 (potassium salt)

**Case number:** 3016

**OPP Chemical Code:** 064101, 064111, 064112

**Molecular weight:** 164.25 (064111)

**Trade name:** Nipacide PTAP

**Basic manufacturer:** Clariant Corporation

Technical 4-t-amylphenol is a white solid. 4-t-Amylphenol has a melting
point of 95 C. The water solubility of 4-t-amylphenol is 113.4 ppm.
4-t-Amylphenol has a vapor pressure of 1.16 x 10^-3^ mm Hg at 25^o^ C.

Sodium 4-tert-amylphenate is also a solid with an estimated melting
point of 205 C, water solubility of 4,595 ppm and an estimated vapor
pressure of 7.7 x10^-10^ at 25^o^C. Potassium 4-tert-amylphenate is also
a sold with an estimated melting point of 206 C, water solubility of
3,811 ppm and an estimated vapor pressure of 7.7 x10^-10^ at 25^o^C.

## C. Use Profile 

The following is information on the currently registered uses of
4-t-amylphenol and salts products and an overview of use sites and
application methods. A detailed table of the uses of eligible for
reregistration is contained in Occupational and Residential Exposure
Assessment for this RED.

**Type of Pesticide:** Antimicrobial

**Summary of Use:**

[Food]{.underline}: 4-tert-amylphenol and its salts are applied to the
following use sites, which may result in indirect food contact:
commercial egg washing, handling, hatchery, and processing facilities;
milking equipment; and mushroom houses.

[Non-Food]{.underline}: Farm and agricultural equipment and
structures/premises; beverage processing plants; eating establishment
surfaces, equipment, and utensils; food storage and distribution
equipment and utensils; and food dispensing equipment.

[Residential]{.underline}: Air deodorizer in residential premises, hard
surface disinfection, textiles, and carpets.

**Target Pests:** Viruses, fungi, tuberculocidal microbes, bacteria,
pseudomonacidal microbes, and staphylocidal microbes.

**Formulation Types**: Soluble concentrates, ready-to-use liquid
solutions, pressurized sprays, and impregnated wipes

**Method and Rates of Application**:

[Equipment]{.underline}: Mops, wipes, trigger-pump sprayer, aerosol.

[Application Rates]{.underline}: Concentrations of 4-t-amylphenol and
salts products range from 0.0027%

to 10%.

[Timing]{.underline}: Most labeling indicates product needs to remain on
surface for at least a 10 second contact time before it is removed using
a potable water rinse.

III. **Summary of 4-Tert-Amylphenol** **Risk Assessments**

The purpose of this summary is to assist the reader by identifying the
key features and findings of these risk assessments, and to help the
reader better understand the conclusions reached in the assessments. The
human health and ecological risk assessment documents and supporting
information listed in Appendix C were used to formulate the safety
finding and regulatory decision for 4-t-amylphenol. While the risk
assessments and related addenda are not included in this document, they
are available from the OPP Public Docket and may also be accessed on the
Agency's website at <http://epa.gov/dockets.> Hard copies of these
documents may be found in the OPP public docket under docket number
OPP-2004-0220. The OPP public docket is located in Room 119, Crystal
Mall II, 1801 Bell Street, Arlington, VA, and is open Monday through
Friday, excluding Federal holidays, from 8:30 a.m. to 4:00 p.m.

**A. Human Health Risk Assessment**

**1. Toxicity of 4-tertiary-amylphenol**

A brief overview of the toxicity studies used for determining the
dietary endpoints in the risk assessments are outlined in Table 2.
Further details on the toxicity of 4-t-amylphenol can be found in the
"Toxicology Science Chapter for Reregistration Eligibility Decision
Document", September 2005; and "4-t-amylphenol Report of the
Antimicrobial Division's Toxicology Endpoint Selection Committee
(ADTC)", July 2005. These documents are available on Agency's website in
the EPA Docket at
[http://www/epa.gov/edockets.](http://www/epa.gov/dockets.)
(OPP-2005-0181)

The Agency has reviewed all toxicity studies submitted for
4-t-amylphenol and has determined that the toxicological database is
sufficient for reregistration. Major features of the toxicology profile
are presented below. The toxicology database for 4-t-amylphenol, in
terms of guideline studies, is largely incomplete. 4-t-amylphenol
appears to be a primary dermal and eye irritant (Category I), and it may
be in Category III for acute oral dermal studies, according to data from
the open literature, and two registrant submitted studies. However, four
acceptable guideline acute studies are not available, and the literature
data protocols were inadequate.

**Table 1. Acute Toxicity of 4-t-amylphenol** **Technical**

  ------------------------- ------------ ------------------------- ------------
  **Guideline No./ Study    **MRID       **Results**               **Toxicity
  Type**                    Number**                               Category**

  870.1100 Acute Oral       46616601     LD~50~ \>2000 mg/kg       III
  Toxicity                                                         

  870.1200 Acute Dermal     Not                                    
  Toxicity                  available;                             
                            required                               

  870.1300 Acute Inhalation Not                                    
  Toxicity                  available;                             
                            required                               

  870.2400 Acute Eye        Not                                    
  Irritation                available;                             
                            required                               

  870.2500 Acute Dermal     46616602     Corrosive                 I
  Irritation                                                       

  870.2600 Skin             Not                                    
  Sensitization             available;                             
                            required                               
  ------------------------- ------------ ------------------------- ------------

The doses and toxicological endpoints selected for the dietary exposure
scenarios are summarized in Table 2 below.

**Table 2. Toxicological Endpoints for 4-t-amylphenol and salts
(Dietary)**

+-----------+---------------+---------------+-------------------------+
| **E       | **Dose for    | **Special     | **Study and             |
| xposure** | Risk          | FQPA Safety   | Toxicological Effects** |
|           | Assessment    | Factor and    |                         |
| **S       | and           | Population    |                         |
| cenario** | Uncertainty   | Adjusted      |                         |
|           | Factor**      | Dose**        |                         |
+===========+===============+===============+=========================+
| Acute     | NOAEL = 200   | FQPA SF = 10x | Developmental Toxicity  |
| Dietary   |               |               | Study in Rats           |
|           | mg/kg/day     | **aPAD** =    |                         |
| (Females  |               | [acute        | LOAEL = 500 mg/kg/day   |
| 13-50     | *UF = 100*    | RfD           | based on skeletal       |
| years of  |               | ]{.underline} | effects and decreased   |
| age)      | **Acute RfD** |               | fetal body weight.      |
|           | = 0.67        | FQPA SF       |                         |
|           | mg/kg/day     |               |                         |
|           |               | = 0.6         |                         |
|           |               | mg/kg/day     |                         |
+-----------+---------------+---------------+-------------------------+
| Chronic   | NOAEL=50      | FQPA SF = 10x | Developmental toxicity  |
| Dietary   | mg/kg/day     |               | study in the rat.       |
|           |               | **cPAD** =    |                         |
| (All      | *UF = 100*    | [chronic      | LOAEL = 200 mg/kg/day   |
| pop       |               | RfD           | based on clinical signs |
| ulations) | **Chronic     | ]{.underline} | of toxicity, decreased  |
|           | RfD** =       |               | body weight and body    |
|           | **0.17**      | FQPA SF       | weight gain, and        |
|           | mg/kg/day     |               | decreased food          |
|           |               | = 0.17        | consumption.            |
|           |               | mg/kg/day     |                         |
+-----------+---------------+---------------+-------------------------+

UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL =
no observed adverse effect level, LOAEL = lowest observed adverse effect
level, PAD = population adjusted dose, (a = acute, c = chronic) RfD =
reference dose, MOE = margin of exposure, N/A = Not Applicable

In short-term studies, 4-t-amylphenol produced clinical signs along with
decreased food consumption and body weight in a developmental toxicity
study, but not systemic effects in a 13-week dermal study. The
structural abnormalities and developmental delays that occurred in the
developmental study occurred at higher dose levels than the maternal
effects, suggesting that increased quantitative susceptibility concerns
are not warranted. However, the minimal maternal effects (reversible
clinical signs) seen in the presence of developmental effects increases
concern for qualitative susceptibility.

Available data suggest that 4-t-amylphenol has endocrine disrupter
capabilities (uterotrophic and estrogenic effects) and increased
billirubin production in babies. When taken with the lack of available
developmental and reproductive toxicity data, concerns for FQPA issues
are heightened.

[General Toxicity Observations]{.underline}

[Dietary]{.underline}

The acute RfD is 0.67 mg/kg/day for females (13-50 years), based on
adverse developmental effects (skeletal effects and decreased fetal body
weight) at 500 mg/kg/day in a rat developmental study. The chronic RfD
is 0.17 mg/kg/day based on clinical signs of toxicity and decreased body
weight and food consumption at 200 mg/kg/day in a rat developmental
study. An uncertainty factor of 300 (10X for interspecies extrapolation,
10X for intraspecies variability, and 3X for database uncertainties) was
applied to the NOAEL to obtain the acute and chronic RfDs. A database
uncertainty factor of 3x is applied to non-occupational risk assessments
for 4-t-amylphenol, due to the number and significance of the data gaps
including lack of repeated oral toxicity studies. An additional Food
Quality Protection Factor (FQPA) safety factor is applied, which is
discussed below.

[Incidental Oral]{.underline}

The short- and intermediate-term incidental oral NOAEL is 50 mg/kg/day
from a rat oral developmental toxicity study that noted clinical signs,
decreases in body weight and body weight gain, coupled with decreased
food consumption at 200 mg/kg/day. The target margin of exposure (MOE)
is 3,000 (includes 10X FQPA factor).

[Short- and Intermediate-term Dermal]{.underline}

The short- and intermediate-term dermal NOAEL is 25 mg/kg/day, which is
based on the lack of systemic effects identified up to and including a
dose of 25 mg/kg/day in a rat subchronic dermal toxicity study.
Uncertainty factors or "target" margins of exposure (MOE) for
4-t-amylphenol dermal exposures are 100 for occupational scenarios and
1,000 for residential scenario (includes 10X FQPA factor).

[Short-, Intermediate- and Long-term Inhalation]{.underline}

The short-, intermediate- and long-term inhalation NOAEL is 50 mg/kg/day
from a rat oral developmental toxicity study that noted clinical signs,
decreases in body weight and body weight gain, coupled with decreased
food consumption at 200 mg/kg/day. In the absence of data, it was
conservatively assumed that inhalation absorption is equivalent to oral
absorption (i.e., 100%). For inhalation exposures, the uncertainty
factors are 300 for occupational scenarios and 3,000 for residential
scenarios (includes 10X FQPA factor). An additional 3X database
uncertainty factor was applied due to the absence of inhalation toxicity
data, and studies that address the sensitivity of infants and children.
The 3,000 MOE represents the maximum uncertainty that can be applied
under Agency guidelines and applies to residential exposures.

[Carcinogenicity Classification]{.underline}

There are no lifetime carcinogenicity studies available for
4-t-amylphenol.

###### Mutagenicity Potential

The data base for mutagenicity is considered adequate based on EPA's
1991 mutagenic guidelines and indicates that 4-t-amylphenol is not
mutagenic or genotoxic.

[Endocrine Disruption Potential]{.underline}

EPA is required under the Federal Food Drug and Cosmetic Act (FFDCA), as
amended by FQPA, to develop a screening program to determine whether
certain substances (including all pesticide active and other
ingredients) "may have an effect in humans that is similar to an effect
produced by a naturally occurring estrogen, or other such endocrine
effects as the Administrator may designate." 4-t-Amylphenol has
properties that could indicate Endocrine Disrupting Chemical (EDC)
properties given that available data suggest that 4-t-Amylphenol has
endocrine disruptor capabilities (uterotrophic and estrogenic effects)
and increased billirubin production in babies.

2.  **FQPA Safety Factor**

The FQPA Safety Factor (as required by the Food Quality Protection Act
of 1996) is intended to provide an additional 10-fold safety factor
(10X), to protect for special sensitivity in infants and children to
specific pesticide residues in food, drinking water, or residential
exposures, or to compensate for an incomplete database. The FQPA Safety
Factor has been retained (i.e., remains 10X) for 4-t-amylphenol based on
the limited database, qualitative evidence of sensitivity in the
developmental toxicity study, and the suggestive evidence in the open
literature of possible endocrine effects.

The toxicology data base is not complete with respect to assessing that
increased susceptibility to infants and children as required by FQPA for
4-t-Amylphenol. The rat prenatal developmental study showed no
quantitative evidence of increased susceptibility (i.e., developmental
NOAELs/LOAELs were higher than those for maternal effects). However,
there was qualitative evidence of increased susceptibility \[i.e., fetal
effects (skeletal abnormalities, decreased body weight gain) were
considered to be more severe than the maternal toxicity (reversible
clinical signs) observed at the same dose level\]. In addition, there is
an absence of developmental toxicity data in the rabbit and an absence
of reproductive toxicity data.

3.  **Population Adjusted Dose** **(PAD)**

Dietary risk is characterized in terms of the Population Adjusted Dose
(PAD), which reflects the reference dose (RfD), either acute or chronic,
that has been adjusted to account for the FQPA Safety Factor (SF). This
calculation is performed for each population subgroup. A risk estimate
that is less than 100% of the acute or chronic PAD is not of concern.

**a. Acute PAD**

Acute dietary risk for 4-t-amylphenol is assessed by comparing acute
dietary exposure estimates (in mg/kg/day) to the acute Population
Adjusted Dose (aPAD). Acute dietary risk is expressed as a percent of
the aPAD. The aPAD is the acute reference dose (0.67 mg/kg/day) modified
by the FQPA safety factor. The acute reference dose was derived from a
developmental toxicity study in rats in which both the NOAEL (200
mg/kg/day) and the LOAEL (500 mg/kg/day) were determined. Acute dietary
exposure was estimated only for females ages 13-49 because available
studies did not show a toxicity endpoint attributable to a single
exposure for the general population. The 4-t-amylphenol aPAD is 0.067
mg/kg/day based on a reference dose of 0.6 mg/kg/day, and incorporating
the FQPA safety factor of 10X.

**b. Chronic PAD**

Chronic dietary risk for 4-t-Amylphenol is assessed by comparing chronic
dietary exposure estimates (in mg/kg/day) to the chronic Population
Adjusted Dose (cPAD). Chronic dietary risk is expressed as a percent of
the cPAD. The cPAD is the chronic reference dose (0.17 mg/kg/day)
modified by the FQPA safety factor. The cPAD was derived from a
developmental toxicity study in rats in which both the NOAEL (50
mg/kg/day) and the LOAEL (200 mg/kg/day) were determined. The
4-t-amylphenol cPAD is 0.017 mg/kg/day based on a reference dose of 0.17
mg/kg/day, which includes the incorporation of the FQPA safety factor
(10X) for the overall U.S. population or any population subgroups**.**

4.  **Exposure Assumptions**

The use of antimicrobial chemicals on food or feed contact surfaces,
agricultural commodities, in animal premises and poultry premises
including hatcheries and application to food-grade eggs may result in
pesticide residues in human food. The Agency must determine the risk to
human health that may occur from exposure to these chemicals.

Refrigerators, counter tops, sinks and stoves are use sites on
registered labels. These surfaces that have been treated with the
4-t-amylphenol products may bear small residues of the 4-t-amylphenol
products after rinsing with potable water; i.e., rinsing with potable
water may not remove all residues deposited on the treated surfaces from
the proposed uses. Residues from treated surfaces can migrate to food
coming into contact with the treated and rinsed surfaces and can be
ingested by humans.

In the absence of residue data for 4-t-amylphenol on treated food
contact surfaces, the Agency estimated residue levels that may occur in
food using the highest application rate for food contact surfaces. To
estimate the Estimated Daily Intake (EDI), the Agency has used an FDA
model. The maximum ingredient percentage for 4-t-amylphenol in food
handling establishments from the various labeled ready-to-use products
is 0.054 % a.i (540 ppm). The Agency assumed that food can contact 2000
cm^2^ of treated surfaces, and that 10% of the pesticide migrates to
food based on the Agency Residential SOPs. The use of the 10% transfer
rate instead of the use of a 100% transfer rate that is used in the FDA
Sanitizer Solution Guidelines requires the submission of confirmatory
data to establish the reliability of the use of the10% transfer rate.
These daily estimates were conservatively used to assess both acute and
chronic dietary.

5.  **Dietary (Food) Risk Assessment**

Generally, a dietary risk estimate that is less than 100% of the acute
or chronic PAD does not exceed the Agency's risk concerns. A summary of
acute and chronic risk estimates are shown in Table 3.

**a. Acute Dietary Risk**

An acute dietary risk assessment was conducted for 4-t-amylphenol food
uses. Dietary risk estimates are provided for females 13-49 years old,
the only population subgroup for which an endpoint was selected. The
result of this assessment showed the risk estimate to be 2.7% of the
aPAD and therefore is not of concern

**b. Chronic (Non-cancer) Dietary Risk**

A chronic dietary risk assessment was conducted for 4-t-amylphenol food
uses. The risk analysis assumes daily exposure from the hard surface
disinfection of counter tops. The result of this assessment showed the
risk estimates to be \<42% of the cPAD and therefore are not of

concern. However, since the Agency assumed 10% of the residues are
transferred to foods it is requiring confirmatory data for this transfer
rate because 100% residue transfer indicates risks of concern.

**Table 3: Acute and Chronic Dietary Exposure and Risk**

+---------------+---------------+--------+---------------+-----------+
| **Population  | **Acute       |        | **Chronic     |           |
| Subgroup**    | Dietary**     |        | Dietary**     |           |
+===============+===============+========+===============+===========+
|               | **Dietary     | **^%   | **^Dietary    | **^%\ c   |
|               | Exposure      | \ aPAD | \ Exposure^** | PAD\ b^** |
|               | (mg/kg/day)   | \ b^** |               |           |
|               | ^a^**         |        | **^(mg/       |           |
|               |               |        | kg/day)\ a^** |           |
+---------------+---------------+--------+---------------+-----------+
| adult male    | 0.0015        | NA     | 0.0015        | 9         |
+---------------+---------------+--------+---------------+-----------+
| females       | 0.0018        | 2.7    | 0.0018        | 10.6      |
| (13-50 years) |               |        |               |           |
+---------------+---------------+--------+---------------+-----------+
| inf           | 0.0072        | NA     | 0.0072        | 42        |
| ants/children |               |        |               |           |
+---------------+---------------+--------+---------------+-----------+

NA=not applicable

b.  **Dietary Risk from Drinking Water**

4-t-Amylphenol and its salts are not likely to contaminate surface and
ground waters based on its use patterns and fate characteristics. There
are no currently registered outdoor uses of 4-t-amylphenol and its
salts. Further, the estimated value for biodegradation indicates it may
biodegrade linearly within days in the aquatic environment, although
ultimate biodegradation (mineralization) may take months. It also is
volatile based on its vapor pressure of 0.00116 mmHg, and has a moderate
to slight mobility in soils based on its estimated Koc value of 3799.
The sodium and potassium salts of 4-t-amylphenol also are slightly to
moderately mobile in soils, and are estimated to biodegrade within days
to weeks. Because of the possibility of biodegradation in water and
soils and the lack of outdoor uses, 4-t-amylphenol and its salts are not
likely to contaminate surface and ground waters. Thus, a drinking water
assessment was not conducted.

6.  **Residential Exposure**

Residential exposure assessment considers all potential pesticide
exposure, other than exposure due to residues in food or in drinking
water. Exposure may occur during and after application as a hard surface
disinfectant (e.g., walls, floors, tables, fixtures), to textiles (e.g.,
clothing, diapers, mattresses, bedding) and to carpets. Each route of
exposure (oral, dermal, inhalation) is assessed, where appropriate, and
risk is expressed as a Margin of Exposure (MOE), which is the ratio of
estimated exposure to an appropriate NOAEL. Based on its use patterns,
4-t-amylphenol has been assessed for the residential
mixing/loading/applicator (or "handler") exposure for applications by
homeowners mopping, wiping and spraying hard surfaces. For
post-application exposure, 4-t-amylphenol has been assessed for adults
and children contacting treated hard surfaces/floors, wearing treated
clothing, wearing treated diapers (children), mouthing treated textiles
(children) and bystander inhalation exposure.

a.  **Toxicity**

The toxicological endpoints and associated uncertainty factors used for
assessing the non-dietary risks for 4-t-amylphenol are listed in Table
4.

A MOE greater than or equal to 3,000 is considered adequately protective
for the residential exposure assessment for the incidental oral and
inhalation routes of exposure. The MOE of 3,000 includes 10x for
interspecies extrapolation, 10x for intraspecies variation, 3x for
database uncertainty and the 10x FQPA factor. For the dermal route of
exposure, a MOE greater than or equal to 1,000 is considered adequately
protective for the residential exposure assessment. The MOE of 1,000
includes 10x for interspecies extrapolation, 10x for intraspecies
variation and the 10x FQPA factor.

**Table 4: Toxicity Endpoints Selected for Assessing Occupational and
Residential Risk for 4-t-Amylphenol**

+---------------+--------------+---------------+----------------------+
| **Exposure    | **Dose Used  | **Level of    | **Study and          |
| Scenario**    | in Risk      | Concern for   | Toxicological        |
|               | Assessment** | Risk          | Effects**            |
|               |              | Assessment**  |                      |
+===============+==============+===============+======================+
| Incidental    | Maternal     | **Residential | Developmental        |
| Oral,         | Oral         | LOC for MOE** | toxicity study in    |
|               |              | = 3000        | the rat              |
| Short- and    | NOAEL = 50   |               |                      |
| Inte          | mg/kg/day    | **O           | LOAEL = 200          |
| rmediate-Term |              | ccupational** | mg/kg/day based on   |
|               |              | = NA          | clinical signs of    |
|               |              |               | toxicity, decreased  |
|               |              |               | body weight and body |
|               |              |               | weight gain, and     |
|               |              |               | decreased food       |
|               |              |               | consumption          |
+---------------+--------------+---------------+----------------------+
| Short-, and   | Dermal NOAEL | **Residential | Subchronic dermal    |
| Intermediate  | = 25         | LOC for MOE** | toxicity study in    |
| -Term         |              | = 1000        | Rats                 |
|               | mg/kg/day    |               |                      |
| Dermal        | for systemic | **O           | Systemic LOAEL = not |
|               | effects      | ccupational** | identified. No       |
|               |              | = 100         | systemic effects     |
|               |              |               | identified up to and |
|               |              |               | including 25         |
|               |              |               | mg/kg/day (HDT).     |
|               |              |               |                      |
|               |              |               | Dermal LOAEL= 10     |
|               |              |               | mg/kg/day for dermal |
|               |              |               | effects and          |
|               |              |               | irritation. Dermal   |
|               |              |               | NOAEL=2.5 mg/kg/day  |
+---------------+--------------+---------------+----------------------+
| Short-,       | Oral         | **Residential | Developmental        |
| I             |              | LOC for MOE** | toxicity study in    |
| ntermediate-, | NOAEL = 50   | = 3000        | the rat              |
| and Long-Term | mg/kg/day    |               |                      |
|               |              | **O           | LOAEL = 200          |
| Inhalation    |              | ccupational** | mg/kg/day based on   |
|               |              | = 300         | clinical signs of    |
|               |              |               | toxicity, decreased  |
|               |              |               | body weight and body |
|               |              |               | weight gain, and     |
|               |              |               | decreased food       |
|               |              |               | consumption.         |
+---------------+--------------+---------------+----------------------+
| Cancer        | No cancer    |               |                      |
|               | data         |               |                      |
|               | available    |               |                      |
|               | for          |               |                      |
|               | 4-           |               |                      |
|               | t-amylphenol |               |                      |
+---------------+--------------+---------------+----------------------+

HDT= Highest dose tested

b.  **Residential Handler**

    i.  **Exposure Scenarios, Data and Assumptions**

Residential exposure may occur during application of 4-t-amylphenol as a
hard surface disinfectant (e.g., walls, floors, tables, fixtures), to
textiles (e.g., clothing, diapers, mattresses, bedding) and to carpets.
A number of assumptions, or estimates, such as adult body weight and
area treated per application, are made by the Agency for residential
risk assessment. Also, note that residential handlers are sometimes
addressed somewhat differently than occupational handlers in that
homeowners are assumed to complete all elements of an application
(mix/load/apply) without the use of personal protective equipment.

The quantitative exposure/risk assessment developed for residential
handlers is based on these scenarios:

\(1\) mopping hard surfaces,

\(2\) wiping hard surfaces,

\(3\) using trigger pump equipment to treat hard surfaces and/or
textiles, and

\(4\) application to air using an aerosol spray can

4-t-Amylphenol products are widely used disinfectants and have a large
number of use patterns that are difficult to completely capture in this
assessment. As such, the Agency has selected representative scenarios
for each use site that are believed to be representative of the vast
majority of 4-t-amylphenol uses, based on end-use product application
methods and use amounts.

Surrogate data are available for mopping, wiping, trigger pump spray and
aerosol can application methods. Dermal and inhalation exposures were
assessed for mopping and wiping using proprietary Chemical Manufacturers
Association (CMA) data (CMA 1992, USEPA 1999). These data are based on
individuals mopping floors and receiving exposure via contact with the
mop or with the bucket, or using a finger pump sprayer to apply the
product and then wipe the surfaces with a paper towel. Dermal and
inhalation exposures were assessed for trigger pump spray and aerosol
application methods using *PHED Version 1.1* values found in the
*Residential Exposure SOPs* (U.S. EPA, 1997a, 2001). The surrogate
exposure data in PHED are based on test subjects applying an aerosol
insecticide to baseboards in kitchens. The dermal and inhalation
exposures from these techniques have been normalized by the amount of
active ingredient handled and reported as unit exposures (UE) expressed
as mg/lb ai handled.

In addition, product label maximum application rates, related use
information, and Agency standard values were used to assess residential
handler exposures. For example, it was assumed that one gallon of
diluted solution is used for mopping floors, while 0.5 liters (0.13
gallons) are used in the wiping and trigger pump spray scenario. For
aerosol can spray, it was assumed that one 16 oz can of product is used
in a day. The residential handler scenarios are assumed to be of short-
and intermediate-term duration (1-30 days and 1-6 months)

ii. **Residential Handler Risk Estimates**

Based on toxicological criteria and potential for exposure, the Agency
has conducted dermal and inhalation exposure assessments. As noted
previously, MOEs greater than or equal to 3,000 for the inhalation route
of exposure and 1,000 for dermal exposure are considered adequately
protective for the residential exposure assessment.

A summary of the residential handler exposures and risk are presented on
Table 5. For residential handlers that handle products containing
4-t-amylphenol and its salts, short-term, and intermediate-term MOEs
were above the target MOEs (i.e., \>1000 for dermal and \>3000 for
inhalation) for all scenarios evaluated and thus, do not exceed the
Agency's level of concern.

**Table 5: Estimates of Exposures and Risks to Residential Handlers of
4-t-Amylphenol (Short- and Intermediate-Duration)**

+-----------------+---------+-----------+-------------+-------------+
| **Scenario**    | *       | **I       | **Dermal    | *           |
|                 | *Dermal | nhalation | MOE**       | *Inhalation |
|                 | Dose**  | Dose**    |             | MOE**       |
|                 |         |           | **(Target   |             |
|                 | *       | **(mg/    | M           | **(Target   |
|                 | *(mg/kg | kg/day)** | OE\>1000)** | M           |
|                 | /day)** |           |             | OE\>3000)** |
+-----------------+---------+-----------+-------------+-------------+
| \(1\) Mopping   | 0.00128 | 4.        | 20,000      | 1,200,000   |
|                 |         | 25x10^-5^ |             |             |
+-----------------+---------+-----------+-------------+-------------+
| \(2\) Wiping    | 0.00666 | 1.        | 3,800       | 320,000     |
|                 |         | 56x10^-4^ |             |             |
+-----------------+---------+-----------+-------------+-------------+
| \(3\) Trigger   | 0.00198 | 2.        | 13,000      | 2,300,000   |
| Pump Spray      |         | 16x10^-5^ |             |             |
+-----------------+---------+-----------+-------------+-------------+
| \(4\) Aerosol   | 0.00233 | 2.        | 11,000      | 2,000,000   |
| Spray           |         | 54x10^-5^ |             |             |
+-----------------+---------+-----------+-------------+-------------+

c.  **Residential Post-Application**

    i.  **Exposure Scenarios, Data and Assumptions**

> Residential postapplication exposures result when bystanders (adults
> and children) come in contact with 4-t-amylphenol in areas where
> pesticide end-use products have recently been applied (e.g., treated
> hard surfaces/floors), or when children incidentally ingest the
> pesticide residues through mouthing the treated end products/treated
> articles (i.e., hand-to-mouth or object-to-mouth contact).
>
> For the purposes of this screening level assessment, postapplication
> scenarios have been developed that encompass multiple products, but
> still represent a high end exposure scenario for all products
> represented. Representative postapplication scenarios assessed
> include:
>
> • contacting treated hard surfaces/floors (dermal and incidental oral
> exposure to children),
>
> • wearing treated clothing (dermal exposure to adults and children),
>
> • wearing diapers treated with a trigger-pump spray (dermal exposure
> to children),
>
> • mouthing treated textiles such as clothing and blankets (incidental
> oral exposure to children), and

• postapplication/bystander inhalation exposures from use of
disinfecting/deodorizing products (vapor exposure to adults and
children).

> Typically, most products used in a residential setting result in
> exposures occurring over a short-term time duration (1 -- 30 days). If
> the products are used on a routine basis (i.e., once a week) and the
> active ingredient has a long indoor half-life, exposures may occur
> over an intermediate-term time duration (30 days -- 6 months). At this
> time, the Agency does not have residue dissipation data or reliable
> use pattern data, including the frequency and duration of use of
> antimicrobial products in the residential setting. Even though the
> Agency does not believe that the use patterns of many residential
> products result in intermediate-term exposure, they are assessed to
> provide an upper bound estimate of exposure. The Agency does believe,
> however, that intermediate-term exposure to children may occur in day
> care centers where disinfecting products are used more frequently.
>
> A number of conservative assumptions were used in assessing
> postapplication risks including maximum application rate from the
> label. In addition quantities handled/treated were estimated based on
> information from various sources, including the Draft Standard
> Operating Procedures (SOPs) for Residential Exposure Assessments
> (USEPA 2000, 2001) and the AD Draft Residential SOP use table. In
> certain cases, no standard values were available for some scenarios.
> Assumptions for these scenarios were based on AD estimates and could
> be further refined from input from affected sectors. In the absence of
> data, for both the textile and diaper scenarios, it was assumed that
> either 100% or 5% of 4-t-amylphenol could transfer and be available
> for dermal contact. The Agency will require data to confirm the actual
> transfer factor of 4-t-amylphenol.

No postapplication air concentration data have been submitted for
4-t-amylphenol to determine potential vapor inhalation risk. Therefore,
the Multi-Chamber Concentration and Exposure Model (MCCEM v1.2) was used
to present a screening-level estimate of the potential inhalation risk
to adults and children for the air deodorizer use. MCCEM estimates
average and peak indoor air concentrations of chemicals released from
products or materials in houses, apartments, townhouses, or other
residences. The data libraries in MCCEM contain information about
residential settings. MCCEM estimates inhalation exposures to chemicals,
calculated as single day doses, chronic average daily doses, or lifetime
average daily doses. All dose estimates are potential doses; they do not
account for actual absorption into the body.

ii. **Residential Post-Application Risk Estimates**

Based on toxicological criteria and potential for exposure, the Agency
has conducted dermal, incidental oral and inhalation exposure
assessments. As noted previously, MOEs greater than or equal to 3,000
for incidental oral and inhalation exposure and 1,000 for dermal
exposure are considered adequately protective for the residential
exposure assessment. A summary of the residential post-application
exposures and risk are presented on Table 6.

The child short- and intermediate-term dermal MOEs for contact following
hard surface disinfection is above the target MOE of 1,000 for
residential settings and slightly below the MOE for daycare centers. The
short- and intermediate-term MOEs for dermal contact with treated
clothing is of concern for young children (MOEs are \<1 assuming a 100%
transfer factor; MOE=17 assuming a 5% transfer factor). For adults, the
dermal MOE is below the target MOE of 1,000 using a 100% transfer factor
(MOE = 140) and above the MOE using the 5% transfer factor. The dermal
MOE for children wearing treated diapers is only of concern (MOE=59)
using a transfer factor of 100%, but it not of concern when using a
transfer factor of 5%. In addition, it should be noted that
4-t-amylphenol caused dermal irritant effects following repeated dermal
exposure, and may also be a potential dermal sensitizer.

> The short- and intermediate-term incidental oral MOEs following hard
> surface disinfection are above the target MOE of 3,000 for residential
> settings and daycare centers, and thus are not of concern. However,
> the oral MOE for children mouthing treated textiles exceeds the
> Agency's level of concern (MOE=650 compared to target MOE\>3,000).
>
> For both adults and children, the calculated inhalation MOEs are
> greater than the target MOE of 3,000 for inhalation exposures
> following use of an air deodorizer, and thus are not of concern.

**Table 6: Summary of Short- and Intermediate-Term Residential
Post-Application Exposures and Risks**

+----------------+-------------+--------------+-----------------------+
| **Scenario**   |             | **Dose**     | **MOE**               |
|                |             |              |                       |
|                |             | **(          | **(Target MOE\>1000   |
|                |             | mg/kg/day)** | dermal;**             |
|                |             |              |                       |
|                |             |              | **\>3000 oral and     |
|                |             |              | inhalation)**         |
+----------------+-------------+--------------+-----------------------+
| **Dermal       |             |              |                       |
| Exposure**     |             |              |                       |
+----------------+-------------+--------------+-----------------------+
| Hard surface   | Residential | 0.0067       | 3,700                 |
| Disinfection   | Setting     |              |                       |
+----------------+-------------+--------------+-----------------------+
|                | Daycare     | 0.0267       | 940                   |
|                | center      |              |                       |
+----------------+-------------+--------------+-----------------------+
| Treated        | Adults      | 0.0092 (5%   | 2,700                 |
| clothing       |             | transfer)    |                       |
|                |             |              | **140**               |
|                |             | 0.185 (100%  |                       |
|                |             | transfer)    |                       |
+----------------+-------------+--------------+-----------------------+
|                | Children    | 1.45 (5%     | **17**                |
|                |             | transfer)    |                       |
|                |             |              | **\<1**               |
|                |             | 28.9 (100%   |                       |
|                |             | transfer)    |                       |
+----------------+-------------+--------------+-----------------------+
| Treated        | Children    | 0.0212 (5%   | 1,200                 |
| Diapers        |             | transfer)    |                       |
|                |             |              | **59**                |
|                |             | 0.424 (100%  |                       |
|                |             | transfer)    |                       |
+----------------+-------------+--------------+-----------------------+
| **Incidental   |             |              |                       |
| Oral           |             |              |                       |
| Exposure**     |             |              |                       |
+----------------+-------------+--------------+-----------------------+
| Hard surface   | Residential | 0.000817     | 61,000                |
| Disinfection   | Setting     |              |                       |
+----------------+-------------+--------------+-----------------------+
|                | Daycare     | 0.00155      | 32,000                |
|                | center      |              |                       |
+----------------+-------------+--------------+-----------------------+
| Treated        | Children    |              | **650**               |
| clothing       |             |              |                       |
+----------------+-------------+--------------+-----------------------+
| **Inhalation   |             |              |                       |
| Exposure**     |             |              |                       |
+----------------+-------------+--------------+-----------------------+
| Air Deodorizer | Adults      | 0.00186      | 27,000                |
+----------------+-------------+--------------+-----------------------+
|                | Children    | 0.00666      | 7,500                 |
+----------------+-------------+--------------+-----------------------+

**7. Aggregate Risk**

The Food Quality Protection Act amendments to the Federal Food, Drug,
and Cosmetic Act (FFDCA, Section 408(b)(2)(A)(ii)) require "that there
is a reasonable certainty that no harm will result from aggregate
exposure to pesticide chemical residue, including all anticipated
dietary exposures and other exposures for which there are reliable
information." Aggregate exposure will typically include exposures from
food, drinking water, residential uses of a pesticide, and other
non-occupational sources of exposure. Since no drinking water estimates
were developed for 4-t-amylphenol, aggregate assessments include
exposure to food and as a result of residential uses only.

Typically, aggregate risk assessments are conducted for acute (1 day),
short-term (1-30 days), intermediate-term (1-6 months) and chronic (6
months to lifetime) exposures. However, acute and chronic aggregate
assessments were not conducted because there are no significant impacts
to drinking water sources, nor are there long-term residential uses.
Thus, only short- and intermediate-term aggregate assessments were
conducted. Oral and inhalation exposure and risk estimates were combined
for the aggregate risk assessment because these endpoints are based on
the same toxicity study (oral developmental study) and effects of
concern (clinical signs and changes in body weight and food
consumption). Dermal exposures were not aggregated with the oral or
inhalation exposures due to different toxicological endpoints for oral
(clinical signs and body weight changes), and dermal (no systemic
effects at the highest dose tested).

**a. Short- and Intermediate-Term Aggregate Risk**

Aggregate short- and intermediate-term risk assessments are designed to
provide estimates of risk likely to result from exposures to the
pesticide or pesticide residues in food, water, and from residential (or
other non-occupation) pesticide uses. Short- and intermediate-term
aggregate risks are considered together because the exposure and
toxicity endpoints are identical for incidental oral and inhalation
residential exposures for both durations. For children, the short- and
intermediate-term aggregate assessment includes average dietary exposure
(food) and estimated incidental oral exposures to children from
residential uses such as hard surface disinfection. In addition,
inhalation exposure from postapplication of an air deodorizer use was
aggregated with the oral exposures since the toxicity endpoint is the
same. For adults, the aggregate assessment includes dietary (oral) and
residential inhalation exposures from wiping a hard surface
disinfectant, in addition to post application inhalation exposure from
the air deodorizer.

The results of the aggregate short- and intermediate-term risk
assessments are presented in Table 7. The aggregate oral and inhalation
risks are not of concern for adults, as the total aggregate MOE is
greater than the target of 3,000. For children, the aggregate risk
estimates are also above the target MOE of 3,000 and thus are not of
concern. As noted previously, incidental oral exposures to treated
textiles are not included in the aggregate assessment because the oral
MOE is already of concern.

A dermal aggregate assessment was not conducted because the toxicity
effects for the dermal exposure route are not the same as the
oral/inhalation exposure route. However, as shown previously on Table 6,
short- and intermediate dermal risks are already of concern for
residents for the treated textile and diaper use.

**Table 7. Summary of Short- and Intermediate-Term Aggregate Risk
Estimates**

+-------------+-------------+-------------+-------------+-------------+
| **Exposure  | **Dose**    |             | **Total MOE |             |
| Scenario**  |             |             | (b)**       |             |
|             | **(m        |             |             |             |
|             | g/kg/day)** |             | **(Target   |             |
|             |             |             | MOE\>3000** |             |
+-------------+-------------+-------------+-------------+-------------+
| Oral        | [Child]{    | [Adult]{    | [Child]{    | [Adult]{    |
| Exposure    | .underline} | .underline} | .underline} | .underline} |
|             |             |             |             |             |
| Dietary     | 0.0072      | 0.0018(a)   | 6940 (c)    | 28,000 (c)  |
| Exposure    |             |             |             |             |
|             | 0.00155     | NA          | 32,000      | NA          |
| Hard        |             |             |             |             |
| Surface     |             |             |             |             |
| D           |             |             |             |             |
| isinfection |             |             |             |             |
| -- Daycare  |             |             |             |             |
| Center      |             |             |             |             |
+-------------+-------------+-------------+-------------+-------------+
| Inhalation  | NA          | 0.000156    | NA          | 320,000     |
| Exposure    |             |             |             |             |
|             |             |             |             |             |
| Handler of  |             |             |             |             |
| hard        |             |             |             |             |
|             |             |             |             |             |
| surface     |             |             |             |             |
|             |             |             |             |             |
| D           |             |             |             |             |
| isinfectant |             |             |             |             |
| -- wiping   |             |             |             |             |
+-------------+-------------+-------------+-------------+-------------+
| Air         | 0.00666     | 0.00186     | 7,500       | 27,000      |
| Deodorizer  |             |             |             |             |
+-------------+-------------+-------------+-------------+-------------+
| Total       | 0.0154      | 0.00316     | 3,240       | 13,000      |
| Aggregate   |             |             |             |             |
| Dose & MOE  |             |             |             |             |
+-------------+-------------+-------------+-------------+-------------+

NA: Not Applicable.

(a): Chronic Dietary Exposure for Females (13-50 years).

(b): MOE = NOAEL (mg/kg/day) / potential dose rate (mg/kg/day) \[Where
short- &

intermediate-term oral NOAEL = 50.

(c): Risk estimates are equivalent to percent of the PAD of 42% for
child and 10.6% for adults.

**b. Long-Term Aggregate Risk**

A long-term (or chronic) aggregate assessment was not undertaken because
the only long-term residential use (diaper use) results in dermal
exposure, which has a different toxicological effect than the chronic
dietary oral exposure.

**8. Occupational Exposure and Risk**

Workers can be exposed to a pesticide through mixing, loading, and/or
applying a pesticide, or re-entering treated sites. Occupational
handlers of 4-t-amylphenol include workers in a variety of occupational
settings. Additionally, postapplication exposures are likely to occur in
these settings. The representative scenarios selected for assessment
were evaluated using maximum application rates as recommended on the
product labels for 4-t-amylphenol.

Occupational risk is assessed for exposure at the time of application
(termed "handler" exposure) and is assessed for exposure following
application, or post-application exposure. Application parameters are
generally defined by the physical nature of the formulation (e.g.,
formula and packaging), by the equipment required to deliver the
chemical to the use site, and by the application rate required to
achieve an efficacious dose.

Occupational risk for all of these potentially exposed populations is
measured by a Margin of Exposure (MOE) which determines how close the
occupational exposure comes to a No Observed Adverse Effect Level
(NOAEL) from toxicological studies. In the case of 4-t-amylphenol, MOEs
greater than 100 for dermal exposures and 300 for inhalation exposures
are not of concern to the Agency. For workers entering a treated site,
MOEs are calculated for each day after application to determine the
minimum length of time required before workers can safely re-enter.

For more information on the assumptions and calculations of
4-t-amylphenol 's potential risk to workers, see the Occupational
Exposure Assessment (Section 8.0) in the "AD Risk Assessment for the
Reregistration Eligibility Decision (RED) Document"(Revised)," dated
September, 2005. 3

**a. Occupational Toxicity**

Table 4 provides a listing of the toxicological endpoints used in the
occupational risk assessment for 4-t-amylphenol.

b.  **Occupational Handler Exposure**

Potential occupational handler exposure can occur at various use sites,
including agricultural premises, food handling,
commercial/institutional/industrial premises, and medical premises. MOEs
are: \>100 for dermal exposure and; \>300 for inhalation exposure. Only
the high pressure spray in the agricultural use scenario was evaluated
using gloved data.

The Agency has determined that there is potential for dermal and
inhalation worker exposure to 4-t-amylphenol at various use sites
including agricultural premises, food handling,
commercial/institutional/industrial premises, and medical premises. To
assess handler risks, the Agency used surrogate unit exposure data from
both proprietary Chemical Manufacturers (CMA) antimicrobial exposure
study and the Pesticide Handlers Exposure Database (PHED).

c.  **Occupational Handler Risk Summary**

For the occupational handler dermal and inhalation risk assessment, the
short- and intermediate- term risks calculated at baseline exposure (no
gloves and no respirators) were above target MOEs for all scenarios
(i.e., dermal MOEs were \>100 and inhalation MOEs were \>300). Note,
however, that the high pressure spray application method in the
agricultural use site category was assessed using gloved data. A summary
of the results of the occupational handler assessment is provided in
Table 8.

**Table 8: Short-, Intermediate-Term Risks for Occupational Handlers**

+--------+---+---------+--------+----------+---------+---------+---------+
| **Ex   | * |         | *      | **       | **MOE** |         |         |
| posure | * |         | *Appli | Quantity |         |         |         |
| Scen   | M |         | cation | Ha       |         |         |         |
| ario** | e |         | Rate   | ndled/** |         |         |         |
|        | t |         | (lb    |          |         |         |         |
|        | h |         | ai/    | *        |         |         |         |
|        | o |         | gal    | *Treated |         |         |         |
|        | d |         | lon)** | per day  |         |         |         |
|        | o |         |        | (ga      |         |         |         |
|        | f |         |        | llons)** |         |         |         |
|        | A |         |        |          |         |         |         |
|        | p |         |        |          |         |         |         |
|        | p |         |        |          |         |         |         |
|        | l |         |        |          |         |         |         |
|        | i |         |        |          |         |         |         |
|        | c |         |        |          |         |         |         |
|        | a |         |        |          |         |         |         |
|        | t |         |        |          |         |         |         |
|        | i |         |        |          |         |         |         |
|        | o |         |        |          |         |         |         |
|        | n |         |        |          |         |         |         |
|        | * |         |        |          |         |         |         |
|        | * |         |        |          |         |         |         |
+--------+---+---------+--------+----------+---------+---------+---------+
|        |   |         |        |          | **B     | **PPE   | **B     |
|        |   |         |        |          | aseline | Gloves  | aseline |
|        |   |         |        |          | Dermal  | Dermal  | Inhal   |
|        |   |         |        |          | (a)**   | (b)**   | ation** |
|        |   |         |        |          |         |         |         |
|        |   |         |        |          | **      | **      | **      |
|        |   |         |        |          | (Target | (Target | (Target |
|        |   |         |        |          | MOE\    | MOE\    | MOE\    |
|        |   |         |        |          | >100)** | >100)** | >300)** |
+--------+---+---------+--------+----------+---------+---------+---------+
| **     |   |         |        |          |         |         |         |
| Agricu |   |         |        |          |         |         |         |
| ltural |   |         |        |          |         |         |         |
| Pr     |   |         |        |          |         |         |         |
| emises |   |         |        |          |         |         |         |
| and    |   |         |        |          |         |         |         |
| Equip  |   |         |        |          |         |         |         |
| ment** |   |         |        |          |         |         |         |
+--------+---+---------+--------+----------+---------+---------+---------+
| Appli  | L |         | 0.0034 | 10       | 270     | No Data | 150,000 |
| cation | o |         |        |          |         |         |         |
| to     | w |         |        |          |         |         |         |
| hard   | P |         |        |          |         |         |         |
| su     | r |         |        |          |         |         |         |
| rfaces | e |         |        |          |         |         |         |
|        | s |         |        |          |         |         |         |
|        | s |         |        |          |         |         |         |
|        | u |         |        |          |         |         |         |
|        | r |         |        |          |         |         |         |
|        | e |         |        |          |         |         |         |
|        | H |         |        |          |         |         |         |
|        | a |         |        |          |         |         |         |
|        | n |         |        |          |         |         |         |
|        | d |         |        |          |         |         |         |
|        | w |         |        |          |         |         |         |
|        | a |         |        |          |         |         |         |
|        | n |         |        |          |         |         |         |
|        | d |         |        |          |         |         |         |
+--------+---+---------+--------+----------+---------+---------+---------+
|        | H |         |        | 40       | No Data | 5,100   | 210,000 |
|        | i |         |        |          |         |         |         |
|        | g |         |        |          |         |         |         |
|        | h |         |        |          |         |         |         |
|        | P |         |        |          |         |         |         |
|        | r |         |        |          |         |         |         |
|        | e |         |        |          |         |         |         |
|        | s |         |        |          |         |         |         |
|        | s |         |        |          |         |         |         |
|        | u |         |        |          |         |         |         |
|        | r |         |        |          |         |         |         |
|        | e |         |        |          |         |         |         |
|        | H |         |        |          |         |         |         |
|        | a |         |        |          |         |         |         |
|        | n |         |        |          |         |         |         |
|        | d |         |        |          |         |         |         |
|        | w |         |        |          |         |         |         |
|        | a |         |        |          |         |         |         |
|        | n |         |        |          |         |         |         |
|        | d |         |        |          |         |         |         |
+--------+---+---------+--------+----------+---------+---------+---------+
|        | M |         |        | 2        | 3,600   | No Data | 220,000 |
|        | o |         |        |          |         |         |         |
|        | p |         |        |          |         |         |         |
|        | p |         |        |          |         |         |         |
|        | i |         |        |          |         |         |         |
|        | n |         |        |          |         |         |         |
|        | g |         |        |          |         |         |         |
+--------+---+---------+--------+----------+---------+---------+---------+
|        | W |         |        | 0.26     | 690     | No Data | 59,000  |
|        | i |         |        |          |         |         |         |
|        | p |         |        |          |         |         |         |
|        | i |         |        |          |         |         |         |
|        | n |         |        |          |         |         |         |
|        | g |         |        |          |         |         |         |
+--------+---+---------+--------+----------+---------+---------+---------+
|        | T |         |        | 0.26     | 10,000  | 24,000  | 3,      |
|        | r |         |        |          |         |         | 000,000 |
|        | i |         |        |          |         |         |         |
|        | g |         |        |          |         |         |         |
|        | g |         |        |          |         |         |         |
|        | e |         |        |          |         |         |         |
|        | r |         |        |          |         |         |         |
|        | P |         |        |          |         |         |         |
|        | u |         |        |          |         |         |         |
|        | m |         |        |          |         |         |         |
|        | p |         |        |          |         |         |         |
|        | S |         |        |          |         |         |         |
|        | p |         |        |          |         |         |         |
|        | r |         |        |          |         |         |         |
|        | a |         |        |          |         |         |         |
|        | y |         |        |          |         |         |         |
+--------+---+---------+--------+----------+---------+---------+---------+
| Fogger | L |         | 0.163  | 15,000   | 120     | No Data | 4,500   |
|        | i |         | lb     | ft2      |         |         |         |
|        | q |         | a      |          |         |         |         |
|        | u |         | i/gal/ |          |         |         |         |
|        | i |         |        |          |         |         |         |
|        | d |         | 6,000  |          |         |         |         |
|        | P |         | ft2    |          |         |         |         |
|        | o |         |        |          |         |         |         |
|        | u |         |        |          |         |         |         |
|        | r |         |        |          |         |         |         |
|        | o |         |        |          |         |         |         |
|        | f |         |        |          |         |         |         |
|        | s |         |        |          |         |         |         |
|        | o |         |        |          |         |         |         |
|        | l |         |        |          |         |         |         |
|        | u |         |        |          |         |         |         |
|        | b |         |        |          |         |         |         |
|        | l |         |        |          |         |         |         |
|        | e |         |        |          |         |         |         |
|        | c |         |        |          |         |         |         |
|        | o |         |        |          |         |         |         |
|        | n |         |        |          |         |         |         |
|        | c |         |        |          |         |         |         |
|        | e |         |        |          |         |         |         |
|        | n |         |        |          |         |         |         |
|        | t |         |        |          |         |         |         |
|        | r |         |        |          |         |         |         |
|        | a |         |        |          |         |         |         |
|        | t |         |        |          |         |         |         |
|        | e |         |        |          |         |         |         |
+--------+---+---------+--------+----------+---------+---------+---------+
| **Food |   |         |        |          |         |         |         |
| Hand   |   |         |        |          |         |         |         |
| ling** |   |         |        |          |         |         |         |
+--------+---+---------+--------+----------+---------+---------+---------+
| Appli  | L |         | 0.0025 | 2        | 1,800   | No Data | 1,      |
| cation | o |         |        |          |         |         | 000,000 |
| to     | w |         |        |          |         |         |         |
| indoor | P |         |        |          |         |         |         |
| hard   | r |         |        |          |         |         |         |
| su     | e |         |        |          |         |         |         |
| rfaces | s |         |        |          |         |         |         |
|        | s |         |        |          |         |         |         |
|        | u |         |        |          |         |         |         |
|        | r |         |        |          |         |         |         |
|        | e |         |        |          |         |         |         |
|        | H |         |        |          |         |         |         |
|        | a |         |        |          |         |         |         |
|        | n |         |        |          |         |         |         |
|        | d |         |        |          |         |         |         |
|        | w |         |        |          |         |         |         |
|        | a |         |        |          |         |         |         |
|        | n |         |        |          |         |         |         |
|        | d |         |        |          |         |         |         |
+--------+---+---------+--------+----------+---------+---------+---------+
|        | M |         |        | 2        | 4,900   | No Data | 290,000 |
|        | o |         |        |          |         |         |         |
|        | p |         |        |          |         |         |         |
|        | p |         |        |          |         |         |         |
|        | i |         |        |          |         |         |         |
|        | n |         |        |          |         |         |         |
|        | g |         |        |          |         |         |         |
+--------+---+---------+--------+----------+---------+---------+---------+
|        | W |         |        | 0.26     | 940     | No Data | 80,000  |
|        | i |         |        |          |         |         |         |
|        | p |         |        |          |         |         |         |
|        | i |         |        |          |         |         |         |
|        | n |         |        |          |         |         |         |
|        | g |         |        |          |         |         |         |
+--------+---+---------+--------+----------+---------+---------+---------+
|        | T |         |        | 0.26     | 7,300   | 17,000  | 2,      |
|        | r |         |        |          |         |         | 100,000 |
|        | i |         |        |          |         |         |         |
|        | g |         |        |          |         |         |         |
|        | g |         |        |          |         |         |         |
|        | e |         |        |          |         |         |         |
|        | r |         |        |          |         |         |         |
|        | P |         |        |          |         |         |         |
|        | u |         |        |          |         |         |         |
|        | m |         |        |          |         |         |         |
|        | p |         |        |          |         |         |         |
|        | S |         |        |          |         |         |         |
|        | p |         |        |          |         |         |         |
|        | r |         |        |          |         |         |         |
|        | a |         |        |          |         |         |         |
|        | y |         |        |          |         |         |         |
+--------+---+---------+--------+----------+---------+---------+---------+
| **     |   |         |        |          |         |         |         |
| Commer |   |         |        |          |         |         |         |
| cial/I |   |         |        |          |         |         |         |
| nstitu |   |         |        |          |         |         |         |
| tional |   |         |        |          |         |         |         |
| Prem   |   |         |        |          |         |         |         |
| ises** |   |         |        |          |         |         |         |
+--------+---+---------+--------+----------+---------+---------+---------+
| Appli  | L |         | 0.005  | 2        | 920     | No Data | 510,000 |
| cation | o |         |        |          |         |         |         |
| to     | w |         |        |          |         |         |         |
| indoor | P |         |        |          |         |         |         |
| hard   | r |         |        |          |         |         |         |
| su     | e |         |        |          |         |         |         |
| rfaces | s |         |        |          |         |         |         |
|        | s |         |        |          |         |         |         |
|        | u |         |        |          |         |         |         |
|        | r |         |        |          |         |         |         |
|        | e |         |        |          |         |         |         |
|        | H |         |        |          |         |         |         |
|        | a |         |        |          |         |         |         |
|        | n |         |        |          |         |         |         |
|        | d |         |        |          |         |         |         |
|        | w |         |        |          |         |         |         |
|        | a |         |        |          |         |         |         |
|        | n |         |        |          |         |         |         |
|        | d |         |        |          |         |         |         |
+--------+---+---------+--------+----------+---------+---------+---------+
|        | M |         |        | 2        | 2,400   | No Data | 150,000 |
|        | o |         |        |          |         |         |         |
|        | p |         |        |          |         |         |         |
|        | p |         |        |          |         |         |         |
|        | i |         |        |          |         |         |         |
|        | n |         |        |          |         |         |         |
|        | g |         |        |          |         |         |         |
+--------+---+---------+--------+----------+---------+---------+---------+
|        | W |         |        | 0.26     | 470     | No Data | 40,000  |
|        | i |         |        |          |         |         |         |
|        | p |         |        |          |         |         |         |
|        | i |         |        |          |         |         |         |
|        | n |         |        |          |         |         |         |
|        | g |         |        |          |         |         |         |
+--------+---+---------+--------+----------+---------+---------+---------+
|        | T |         |        | 0.26     | 7,100   | 17,000  | 2,      |
|        | r |         |        |          |         |         | 100,000 |
|        | i |         |        |          |         |         |         |
|        | g |         |        |          |         |         |         |
|        | g |         |        |          |         |         |         |
|        | e |         |        |          |         |         |         |
|        | r |         |        |          |         |         |         |
|        | P |         |        |          |         |         |         |
|        | u |         |        |          |         |         |         |
|        | m |         |        |          |         |         |         |
|        | p |         |        |          |         |         |         |
|        | S |         |        |          |         |         |         |
|        | p |         |        |          |         |         |         |
|        | r |         |        |          |         |         |         |
|        | a |         |        |          |         |         |         |
|        | y |         |        |          |         |         |         |
+--------+---+---------+--------+----------+---------+---------+---------+
| Air    |   | Aerosol | 0.074% | 3 16 oz  | 4,100   | 9,700   | 1.      |
| D      |   | Spray   | ai by  | cans     |         |         | 200,000 |
| eodori |   |         | weight |          |         |         |         |
| zation |   |         |        |          |         |         |         |
+--------+---+---------+--------+----------+---------+---------+---------+
| **M    |   |         |        |          |         |         |         |
| edical |   |         |        |          |         |         |         |
| Pr     |   |         |        |          |         |         |         |
| emises |   |         |        |          |         |         |         |
| and    |   |         |        |          |         |         |         |
| Equip  |   |         |        |          |         |         |         |
| ment** |   |         |        |          |         |         |         |
+--------+---+---------+--------+----------+---------+---------+---------+
| Appli  |   | Low     | 0.005  | 2        | 920     | No Data | 510,000 |
| cation |   | P       |        |          |         |         |         |
| to     |   | ressure |        |          |         |         |         |
| indoor |   | H       |        |          |         |         |         |
| hard   |   | andwand |        |          |         |         |         |
| su     |   |         |        |          |         |         |         |
| rfaces |   |         |        |          |         |         |         |
+--------+---+---------+--------+----------+---------+---------+---------+
|        |   | Mopping |        | 45       | 110     | No Data | 6,500   |
+--------+---+---------+--------+----------+---------+---------+---------+
|        |   | Wiping  |        | 0.26     | 470     | No Data | 40,000  |
+--------+---+---------+--------+----------+---------+---------+---------+
|        |   | Trigger |        | 0.26     | 7,100   | 17,000  | 2,      |
|        |   | Pump    |        |          |         |         | 100,000 |
|        |   | Spray   |        |          |         |         |         |
+--------+---+---------+--------+----------+---------+---------+---------+
| Air    |   | Aerosol | 0.074% | 3 16 oz  | 4,100   | 9,700   | 1,      |
| D      |   | Spray   | ai by  | cans     |         |         | 200,000 |
| eodori |   |         | weight |          |         |         |         |
| zation |   |         |        |          |         |         |         |
+--------+---+---------+--------+----------+---------+---------+---------+

\(a\) Baseline Dermal: Long-sleeve shirt, long pants, no gloves.

\(b\) PPE Dermal with gloves: baseline dermal plus chemical-resistant
gloves.

d.  **Occupational Post-application Risk Summary**

For most of the occupational scenarios, postapplication dermal exposure
is not expected to occur or is expected to be negligible based on the
application rates and chemical properties of the chemical.
Postapplication/bystander inhalation exposures, however, were assessed
for entry into a building after a fogging application. The
representative building selected was a poultry barn. The Agency used the
MCCEM (Multi- Chamber Concentration and Exposure Model) to estimate
postapplication/bystander exposures. The calculated inhalation MOEs were
above the target MOE of 300 for all fogging postapplication scenarios
with the exception of the scenario for 8-hr exposure to the product with
a 2-hr reentry interval (MOE = 86).

The Agency does not believe that any mitigation is necessary to address
the post-application scenario with a 2-hr reentry interval at this time.
The risk estimate was calculated using the Agency's standard assumptions
for air exchange rates. The Agency believes that in the case of animal
barns and facilities this assumption in very conservative given the
relatively high air exchange rates for such facilities.

**e. Human Incident Data**

There are some reported incidents associated with exposure to end-use
products containing 4-t-amylphenol. Dermal, ocular and inhalation are
the primary routes of exposure. Most of the incidents are related to
irritation reaction. The most common symptoms reported for cases of
inhalation exposure were respiratory irritation/burning, irritation to
mouth/throat/nose, coughing/choking, shortness of breath, dizziness,
flu-like symptoms, and headache. Eye pains, burning of eyes,
conjunctivivitis, blurring vision, and acute inflammation have been
reported in ocular incidents. Neurological effects, such as dizziness,
headache and blurred vision also have been reported.

**B. Environmental Risk Assessment**

A summary of the Agency's environmental risk assessment is presented
below. The following risk characterization is intended to describe the
magnitude of the estimated environmental risks for 4-t-amylphenol use
sites and any associated uncertainties. A detailed ecological hazard and
environmental risk assessment for 4-t-amylphenol and its salts is
presented in "Ecological Hazard and Environmental Risk Assessment for
4-tert-amylphenol and salts to be included in the RED", September 2005.
A brief summary is presented below.

1.  **Environmental Fate and Transport**

The environmental fate assessment for 4-t-amylphenol and its potassium
and sodium salts is based on US EPA=s Estimation Programs Interface
(EPI) Suite. EPI Suite provides estimations of physical/chemical
properties and environmental fate properties.

4-t-Amylphenol may be bioaccumlative (log K~OW~ 3.91) and is likely to
pose a concern for aquatic organisms. It is expected to have moderate to
slight mobility in soils based upon the estimated Koc value of 3799.
Estimated value for biodegradation probability indicates that it may
biodegrade linearly within days in aquatic medium. However, ultimate
biodegradation (mineralization) may take months. It is volatile and may
vaporize into the atmosphere. The estimated half life in the air for
4-t-amylphenol is about three hours which indicates that it is not
persistent in air. Because of the possibility of biodegradation in water
and soils, it is not likely to contaminate surface and ground waters.

4-t-Amylphenol, potassium salt, is not likely to be bioaccumlative ( log
K~OW~ 1.23) and may not pose a concern for bioconcentration in aquatic
organisms. It may be expected to have moderate to slight mobility in
soils as its estimated Koc value is 3799. Estimated probability of
biodegradation of 4-t-amylphenol, potassium salt, in soils and water
indicates that it is likely to biodegrade within days to weeks.
Therefore, it may be unlikely that soil and water contamination would
take place. It has low volatility and its estimated half life in air is
about 4.68 hours and is not likely to be persistent in air.

4-t-Amylphenol, sodium salt, is not likely to be bioaccumlative (log
K~OW~ is 1.23) and may not pose a concern for bioconcentration in
aquatic organisms. It may be expected to have moderate to slight
mobility in soils as its estimated Koc value is the same as the parent
molecule, 4-t-amylphenol. Probability for sodium 4-t-amylphenate
biodegradation is the same as the parent molecule, 4-t-amylphenol.
Hence, it is not likely to persist in soils and water, and surface and
ground water contamination is not likely to occur. It has low volatility
and its estimated half life in air is about 4.68 hours and is not likely
to be persistent in air.

2.  **Ecological Risk**

    Guideline ecological effects data has not submitted for
    4-t-amylphenol. The only data that was available was found in the
    peer-reviewed literature. None of these studies met current
    guideline requirements and therefore, could not be used in a risk
    assessment. There is a concern about the possibility of endocrine
    disruption in fish, since 4-t-amylphenol is considered an
    ecoestrogen. This was documented in several studies on carp
    (*Cyprimus carpio)*. However, since this chemical is restricted to
    indoor uses only, the possibility for exposure to fish to
    4-t-amylphenol would be limited. The limited exposure resulting from
    indoor uses of 4-t-amylphenol and its salts is not anticipated to
    cause adverse effects to terrestrial or aquatic organisms.

The acute toxicity data for 4-t-amylphenol are summarized on Table 9. As
shown in Table 9, acute toxicity for freshwater fish ranged from 2.50
mg/L to 16 mg/L in the fathead minnow. The first study was conducted
using criteria similar to OPP/OPPTS guidelines and would have more
weight than the second study which did not provide any information on
how the study was conducted. Therefore, the data indicates that
4-t-amylphenol is moderately toxic to coldwater species, such as the
fathead minnow. The fathead minnow is considered to be less sensitive
than the bluegill. Also shown in Table 9, acute toxicity to shrimp was
LC50 = 1.7 mg/L. This indicated that 4-t-amylphenol was moderately toxic
to shrimp. The study does not meet current guideline requirements.

**Table 9. Acute Toxicity of 4-t-amylphenol** **and salts**

+--------------+------------+--------+------------------+-------------+
| **Organism** | *          | **To   | **Comments**     | **          |
|              | *Results - | xicity |                  | Reference** |
|              | LC50       | Cate   |                  |             |
|              | (mg/L)     | gory** |                  |             |
|              | (95%       |        |                  |             |
|              | Confidence |        |                  |             |
|              | Limit)**   |        |                  |             |
+==============+============+========+==================+=============+
| **Freshwater |            |        |                  |             |
| Fish**       |            |        |                  |             |
+--------------+------------+--------+------------------+-------------+
| Fathead      | 2.50       | mode   | \- 96h test      | Holcombe, G |
| minnow       | (1.87 -    | rately | duration;        | W et al.    |
| (*Pimephales | 3.34)      | toxic  |                  | 1984        |
| promelas*)   |            |        | \- flow-through  | Environ     |
|              |            |        | bioassay         | Pollut ser  |
|              |            |        |                  | A Ecol Biol |
|              |            |        | -caused necrosis | 35:367-81   |
|              |            |        | in fish          |             |
+--------------+------------+--------+------------------+-------------+
| Fathead      | 16         | Sl     | \- No            | Russon, C L |
| minnow       |            | ightly | information      | et al. 1997 |
| *(Pimephales |            | toxic  | available on the | Environ.    |
| promela*s)   |            |        | test parameters  | Toxicol.    |
|              |            |        |                  | Chem 16:948 |
+--------------+------------+--------+------------------+-------------+
| **Mari       |            |        |                  |             |
| ne/Estuarine |            |        |                  |             |
| Inv          |            |        |                  |             |
| ertebrates** |            |        |                  |             |
+--------------+------------+--------+------------------+-------------+
| Shrimp       | 96h LC50 = | Mode   | \- 96h test      | McLeese, D  |
| (*Crangon    | 1.7 mg/L   | rately | duration;        | W 1981      |
| sep          |            | toxic  |                  | Chemosphere |
| temspinosa*) |            |        | \- aerated       | 10(7):723   |
|              |            |        | gently and       |             |
|              |            |        | changed at 49    |             |
|              |            |        | hours            |             |
+--------------+------------+--------+------------------+-------------+

3.  **Endocrine Effects in Fish**

    As mentioned above, potential endocrine effects for 4-t-amylphenol
    have been identified. Examples of the impacts of 4-t-amylphenol
    affecting the reproductive processes of carp have been reported in
    the peer-reported literature. Since the use pattern for this
    chemical is restricted to indoor uses, exposure to fish, such as
    carp, should be limited. Therefore, no additional testing for
    endocrine disruption effects on fish is necessary.

    **Table 10: Examples of 4-t-amylphenol Affecting the Endocrine
    System in Fish**

+------------+--------------+----------+----------------+-------------+
| Organism   | Results      | Toxicity | Comments       | Reference   |
|            |              | Category |                |             |
+============+==============+==========+================+=============+
| Male       | caused       | id       | \- test        | Gimeno et   |
| common     | formation of | entified | concentration  | al. 1997    |
| carp       | oviducts in  | as an    | 0.14 mg/L      |             |
| (*Cyprinus | male fish    | eco      |                | Environ Sci |
| carpio*)   | and reduced  | estrogen | \- exposed     | Technol     |
|            | the number   |          | embryos and    | 31(10):     |
|            | of           |          | fingerlings at | 2884-2890.  |
|            | primordial   |          | various ages   |             |
|            | germ cells   |          |                |             |
|            | in gonads    |          |                |             |
+------------+--------------+----------+----------------+-------------+
| Male       | 30-day EC50  | id       | \- 120 male    | Gimeno, S.  |
| common     | for oviduct  | entified | carp tested    | et al.      |
| carp       | formation =  | as       |                | 1998a       |
| (*Cyprinus | 63 ug/L      | causing  | \- nominal     |             |
| carpio*)   |              | e        | concentrations | Aquatic     |
|            | NOEC for     | ndocrine | of 100, 320, & | Toxicology  |
|            | oviduct      | di       | 1000 ug/L were | (Amsterdam) |
|            | formation =  | sruption | tested         | 43:77-92.   |
|            | \<36 ug/L    | effects  |                |             |
|            | primordial   |          | \- 160 day     |             |
|            | germ cells   |          | test duration  |             |
|            | lower in     |          |                |             |
|            | treated fish |          | \-             |             |
|            | NOEC for     |          | intermittent   |             |
|            | vitellogenin |          | flow through   |             |
|            | induction    |          | system         |             |
|            | =90-256 ug/L |          |                |             |
+------------+--------------+----------+----------------+-------------+
| Cultured   | vitellogenin | id       | -six month old | Smeets, J.  |
| h          | induction in | entified | hepatocytes    | M. et al.   |
| epatocytes | carp         | as       | with fully     | 1999.       |
| from       | hepatocytes  | causing  | mature testes  | Toxicol.    |
| geneticall | with LOEC    | e        | containing     | Sci. 50(2): |
| y-uniform, | ranging from | ndocrine | mature sperm   | 206-213.    |
| all male,  | 5-50 uM,     | di       |                |             |
| F1-hybrid  | cytotoxic at | sruption |                |             |
| progenies  | 100uM        | effects  |                |             |
| of common  |              |          |                |             |
| carp       |              |          |                |             |
| (*Cyprinus |              |          |                |             |
| capio*)    |              |          |                |             |
+------------+--------------+----------+----------------+-------------+
| Male       | elevated     | id       | \- 3 month     | Gimeno et   |
| common     | levels of    | entified | test duration  | al. 1998b   |
| carp       | v            | as       |                | Aquatic     |
| (*Cyprinus | itellogenin, | causing  | \- nominal     | Toxicology  |
| carpio*)   | inhibition   | e        | concentrations | (Amsterdam) |
|            | of           | ndocrine | of 32, 100,    | 43:93-109.  |
|            | sper         | di       | 320 and 1000   |             |
|            | matogenesis, | sruption | ug/L were      |             |
|            | d            | effects  | tested         |             |
|            | isappearance | and      |                |             |
|            | of           |          |                |             |
|            | spermatozoa  | no       |                |             |
|            | and          | m        |                |             |
|            | s            | ortality |                |             |
|            | permatogenic | or       |                |             |
|            | cysts,       | growth   |                |             |
|            | reduced      | effects  |                |             |
|            | diameter of  |          |                |             |
|            | seminiferous |          |                |             |
|            | lobules,     |          |                |             |
|            | reduced      |          |                |             |
|            | spermatocrit |          |                |             |
|            | values and   |          |                |             |
|            | early        |          |                |             |
|            | appearance   |          |                |             |
|            | of           |          |                |             |
|            | ovo-testes   |          |                |             |
|            |              |          |                |             |
|            | LOAEL= 0.032 |          |                |             |
|            | mg/L         |          |                |             |
+------------+--------------+----------+----------------+-------------+

4.  **Listed Species Consideration**

    **a. The Endangered Species Act**

    []{.mark}

Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2),
requires all federal agencies to consult with the National Marine
Fisheries Service (NMFS) for marine and anadromous listed species, or
the United States Fish and Wildlife Services (FWS) for listed wildlife
and freshwater organisms, if they are proposing an \"action\" that may
affect listed species or their designated habitat. Each federal agency
is required under the Act to insure that any action they authorize,
fund, or carry out is not likely to jeopardize the continued existence
of a listed species or result in the destruction or adverse modification
of designated critical habitat. To jeopardize the continued existence of
a listed species means \"to engage in an action that reasonably would be
expected, directly or indirectly, to reduce appreciably the likelihood
of both the survival and recovery of a listed species in the wild by
reducing the reproduction, numbers, or distribution of the species.\" 50
C.F.R. § 402.02.

To facilitate compliance with the requirements of the Endangered Species
Act subsection (a)(2) the Environmental Protection Agency, Office of
Pesticide Programs has established procedures to evaluate whether a
proposed registration action may directly or indirectly reduce
appreciably the likelihood of both the survival and recovery of a listed
species in the wild by reducing the reproduction, numbers, or
distribution of any listed species (U.S. EPA 2004). After the Agency's
screening-level risk assessment is performed, if any of the Agency's
Listed Species LOC Criteria are exceeded for either direct or indirect
effects, a determination is made to identify if any listed or
[candidate]{.mark} species may co-occur in the area of the proposed
pesticide use. If determined that listed or candidate species may be
present in the proposed use areas, further biological assessment is
undertaken. The extent to which listed species may be at risk then
determines the need for the development of a more comprehensive
consultation package as required by the Endangered Species Act.

For certain use categories, the Agency assumes there will be minimal
environmental exposure, and only a minimal toxicity data set is required
(Overview of the Ecological Risk Assessment Process in the Office of
Pesticide Programs U.S. Environmental Protection Agency - Endangered and
Threatened Species Effects Determinations, 1/23/04, Appendix A, Section
IIB, pg.81). Chemicals in these categories therefore do not undergo a
full screening-level risk assessment, and are considered to fall under a
"no effect" determination. Due to the low likelihood of exposure form
the indoor uses of 4-t-amylphenol , the Agency expects no effects to
listed species or critical habitat and therefore makes a \"No Effect\"
determination for this chemical.

**b. General Risk Mitigation**

4-t-Amylphenol end-use products (EPs) may also contain other registered
pesticides. Although the Agency is not proposing any mitigation measures
for products containing 4-t-amylphenol specific to federally listed
species, the Agency needs to address potential risks from other end-use
products. Therefore, the Agency requires that users adopt all listed
species risk mitigation measures for all active ingredients in the
product. If a product contains multiple active ingredients with
conflicting listed species risk mitigation measures, the more stringent
measure(s) should be adopted.

**IV. Risk Management, Reregistration, and Tolerance Reassessment
Decision**

**A. Determination of Reregistration Eligibility**

Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after
submission of relevant data concerning an active ingredient, whether or
not products containing the active ingredient are eligible for
reregistration. The Agency has previously identified and required the
submission of the generic (i.e., active ingredient-specific) data
required to support reregistration of products containing 4-t-amylphenol
and its salts (potassium and sodium) as active ingredients. The Agency
has completed its review of these generic data, and has determined that
the data are sufficient to support reregistration of all supported
products containing 4-t-amylphenol and salts,

The Agency has completed its assessment of the dietary, occupational,
drinking water and ecological risks associated with the use of pesticide
products containing the active ingredients 4-t-amylphenol. Based on a
review of these data and on public comments on the Agency's assessments
for the active ingredients 4-t-amylphenol and its salts (potassium and
sodium), the Agency has sufficient information on the human health and
ecological effects of to make decisions as part of the tolerance
reassessment process under FFDCA and reregistration process under FIFRA,
as amended by FQPA. The Agency has determined that products containing
4-t-amylphenol and its salts are eligible for reregistration provided
that: (i) current data gaps and confirmatory data needs are addressed;
(ii) the risk mitigation measures outlined in this document are adopted;
and (iii) label amendments are made to reflect these measures. Label
changes are described in Section V. Appendix A summarizes the uses of
4-t-amylphenol and salts that are eligible for reregistration. Appendix
B identifies the generic data requirements that the Agency reviewed as
part of its determination of reregistration eligibility of
4-t-amylphenol and salts, and lists the submitted studies that the
Agency found acceptable. Data gaps are identified as generic data
requirements that have not been satisfied with acceptable data.

Based on its evaluation of 4-t-amylphenol and salts, the Agency has
determined that 4-t-amylphenol and salts products, unless labeled and
used as specified in this document, would present risks inconsistent
with FIFRA. Accordingly, should a registrant fail to implement any of
the risk mitigation measures identified in this document, the Agency may
take regulatory action to address the risk concerns from the use of
4-t-amylphenol and salts. If all changes outlined in this document are
incorporated into the product labels, then all current risks for
4-t-amylphenol and salts (potassium and sodium) will be substantially
mitigated for the purposes of this determination.

**B. Public Comments and Responses**

Through the Agency's public participation process, EPA worked with
stakeholders and the public to reach the regulatory decisions for
4-t-amylphenol. During the public comment period on the risk
assessments, which closed on September 19, 2005, the Agency received
comments from the Clariant Corporation regarding risk assessment
assumptions and endocrine disruption potential and from a private
citizen concerned about the diaper use of this chemical. These comments
in their entirety are available in the public docket,
<http://docket.epa.gov/edkpub/index.jsp>[,](http://www.epa.gov/.edocket,)
(OPP-2005-0181).

**C. Regulatory Position**

**1. Food Quality Protection Act (FQPA) Considerations**

**a. "Risk Cup" Determination**

As part of the FQPA tolerance reassessment process, EPA assessed the
risks associated with 4-t-amylphenol. The Agency has concluded that the
tolerance exemption for 4-t-amylphenol meets the FQPA safety standards
and that the risk from dietary (food sources only) exposure is within
the "risk cup." An aggregate assessment was conducted for exposures
through food, drinking water and residential exposure. The Agency has
determined that the human health risks from these combined exposures are
within acceptable levels provided that the mitigation contained in this
document is implemented. In reaching this determination, EPA has
considered the available information on the special sensitivity of
infants and children, as well as aggregate exposure from food, water and
residential exposures.

**b****. Determination of Safety to U.S. Population**

As part of the FQPA tolerance reassessment process, EPA assessed the
risks associated with 4-t-amylphenol and its salts (potassium and
salts). The Agency has determined that the established tolerance
exemption for 4-t-amylphenol and its salts with amendments and changes
as specified in this document, meet the safety standards under the FQPA
amendments to section 408(b) (2) (D) of the FFDCA, and that there is a
reasonable certainty no harm will result to the general population or
any subgroup from the reregistered, labeled uses of 4-t-amylphenol and
salts. In reaching this conclusion, the Agency has considered all
available information on the toxicity, use practices and exposure
scenarios, and the environmental behavior of 4-t-amylphenol and its
salts. Both the acute dietary (food alone) and chronic dietary risks
from 4-t-amylphenol are not of concern. 4-t-Amylphenol and its salts are
not likely to contaminate surface and ground waters based on its use
patterns and fate characteristics. Thus, a drinking water assessment was
not conducted.

Short- and intermediate-term aggregate risk assessments were conducted
for 4-t-amylphenol. The aggregate oral and inhalation risks are not of
concern for adults, as the total aggregate MOE is greater than the
target of 3,000. For children, the aggregate risk estimates are also
above the target MOE of 3,000 and thus are not of concern. As noted
previously, incidental oral exposures to treated textiles are not
included in the aggregate assessment because the oral MOE is already of
concern.

A dermal aggregate assessment was not conducted because the toxicity
effects for the dermal exposure route are not the same as the
oral/inhalation exposure route. However, as shown previously on Table 6,
short- and intermediate dermal risks are already of concern for the
treated textile and diaper uses.

**c. Determination of Safety to Infants and Children**

EPA has determined that the established tolerance exemption for
4-t-amylphenol, with amendments and changes as specified in this
document, meets the safety standards under the FQPA amendments to
section 408(b)(2)(C) of the FFDCA, that there is a reasonable certainty
of no harm for infants and children. The safety determination for
infants and children considers factors of the toxicity, use practices,
and environmental behavior noted above for the general population, but
also takes into account the possibility of increased dietary exposure
due to the specific consumption patterns of infants and children, as
well as the possibility of increased susceptibility to the toxic effects
of 4-t-amylphenol residues in this population subgroup.

A Special FQPA Safety Factor is necessary to protect the safety of
infants and children. In determining whether or not infants and children
are particularly susceptible to toxic effects from 4-t-amylphenol
residues, the Agency considered the completeness of the database for
developmental and reproductive effects, the nature of the effects
observed, and other information. The FQPA Safety Factor has been
retained (i.e., remains 10X) for 4-t-amylphenol based on a lack of
guideline studies, qualitative evidence of sensitivity in the
developmental toxicity study, and the suggestive evidence in the open
literature of possible endocrine effects.

The toxicology data base is not complete with respect to assessing that
increased susceptibility to infants and children as required by FQPA for
4-t-amylphenol. The rat prenatal developmental study showed no
quantitative evidence of increased susceptibility (i.e., developmental
NOAELs/LOAELs were higher than those for maternal effects). However,
there was qualitative evidence of increased susceptibility (i.e., fetal
effects (skeletal abnormalities, decreased body weight gain) were
considered to be more severe than the maternal toxicity (reversible
clinical signs) observed at the same dose level). In addition, there is
an absence of developmental toxicity data in the rabbit and an absence
of reproductive toxicity data.

**d. Endocrine Disruptor Effects**

EPA is required under the FFDCA, as amended by FQPA, to develop a
screening program to determine whether certain substances (including all
pesticide active and other ingredients) "may have an effect in humans
that is similar to an effect produced by a naturally occurring estrogen,
or other endocrine effects as the Administrator may designate."
Following recommendations of its Endocrine Disruptor Screening and
Testing Advisory Committee (EDSTAC), EPA determined that there was a
scientific basis for including, as part of the program, the androgen and
thyroid hormone systems, in addition to the estrogen hormone system. EPA
also adopted EDSTAC's recommendation that EPA include evaluations of
potential effects in wildlife. For pesticides, EPA will use FIFRA and,
to the extent that effects in wildlife may help determine whether a
substance may have an effect in humans, FFDCA authority to require the
wildlife evaluations. As the science develops and resources allow,
screening of additional hormone systems may be added to the Endocrine
Disruptor Screening Program (EDSP).

When the appropriate screening and/or testing protocols being considered
under the EDSP have been developed, 4-t-amylphenol may be subject to
additional screening and/or testing to better characterize effects
related to endocrine disruption.

**e. Cumulative Risks**

Risks summarized in this document are those that result only from the
use of 4-t-amylphenol and salts. The Food Quality Protection Act (FQPA)
requires that the Agency consider "available information" concerning the
cumulative effects of a particular pesticide's residues and "other
substances that have a common mechanism of toxicity." The reason for
consideration of other substances is due to the possibility that
low-level exposures to multiple chemical substances that cause a common
toxic effect by a common toxic mechanism could lead to the same adverse
health effect as would a higher level of exposure to any of the
substances individually. Unlike other pesticides for which EPA has
followed a cumulative risk approach based on a common mechanism of
toxicity, EPA has not made a common mechanism of toxicity finding for
4-t-amylphenol. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the policy statements released
by EPA's Office of Pesticide Programs concerning common mechanism
determinations and procedures for cumulating effects from substances
found to have a common mechanism on EPA's website at
<http://www.epa.gov/pesticides/cumulative/>.

**2. Tolerance Summary**

4-t-amylphenol (also known as phenol, 4-1,1-dimethylpropyl) (CAS No.
80-46-6) has a tolerance exception in 40CFR 180.940 (c) as a
food-contact sanitizer for use in food-processing equipment and utensils
with a not to exceed limit of 80 ppm.

**a. Tolerances Currently Listed Under 40 CFR §180.940(c) and Tolerance
Reassessment**

**Table 11. Tolerance Reassessment Summary for 4-t-amylphenol**

  ------------- ----------- -------------- --------------------------------------
  **Tolerance                              
  Exemption                                
  Listed Under                             
  40 CFR §                                 
  180.940 (c)**                            

  **Use Site**  **Current   **Tolerance    **Correct Definition/Comment**
                Limit       Reassessment   
                (ppm)**     (ppm)**        

  Food          80          540            When ready for use, the end-use
  processing                               concentration is not to exceed 540
  equipment and                            ppm.
  utensils                                 
  ------------- ----------- -------------- --------------------------------------

**b. Codex Harmonization**

Currently there are no Codex MRLs established for 4-t-amylphenol.

**D. Regulatory Rationale**

The Agency has determined that 4-t-amylphenol is eligible for
reregistration provided that additional required data confirm this
decision and that the risk mitigation measures outlined in this document
are adopted, and label amendments are made to reflect these measures.

The following is a summary of the rationale for managing risks
associated with the use of 4-t-amylphenol. Where labeling revisions are
warranted, specific language is set forth in the summary tables of
Section V of this document.

**1. Human Health Risk Management**

**a. Dietary (Food) Risk Mitigation**

For all supported uses, the acute and chronic dietary exposure estimates
are below the Agency's level of concern. Therefore, no risk mitigation
measures are required to address exposure to 4-t-amylphenol residues in
food. Residue data are required to confirm the 10% transfer assumption
used in the risk assessment.

**b. Drinking Water Risk Mitigation**

4-t-Amylphenol and its salts are not likely to contaminate surface and
ground waters based on its use patterns and fate characteristics. Thus,
a drinking water assessment was not conducted. Therefore, no risk
mitigation measures are required to address 4-t-amylphenol exposure from
drinking water.

**c. Residential Risk Mitigation**

Residential risks from handler and post-application exposure were
calculated for short- and intermediate-term dermal, inhalation and
incidental oral exposures. All exposure and risk estimates for
residential handler scenarios are below the Agency's level of concern.
Therefore, no risk mitigation measures are required for these handler
scenarios.

Risks of concern have been identified for several post-application
exposure scenarios including children's dermal exposure to treated
clothing and treated diapers and children's incidental oral exposure to
treated clothing. The Agency believes that adding clear instructions for
washing and rinsing textile items will result in the adequate removal of
residues from the treated items and address the Agency's concerns for
this scenario. The MOE for dermal exposure to children to treated
surfaces in daycare centers slightly exceeds the Agency's level of
concern (MOE = 940 with a target MOE of 1,000). However, the Agency
believes actual exposure from this pathway to not exceed its level of
concern when taking into account the conservative nature of the risk
estimate which is likely to overestimate potential exposures.

In summary, to reduce residential exposure, the Agency has determined
that the following mitigation and label changes for specific scenarios
are appropriate and required for reregistration eligibility:

-   Delete all diaper uses

-   Delete all use on non-laundered textiles\\items including
    mattresses, helmets, headgear, headphones, face gear, and
    mouthpieces.

-   All labels with laundered textile uses must have directions that
    indicate that items must be treated prior to washing and rinsing.

    **d. Occupational Risk Mitigation**

    **i. Handler Exposure**

    Occupational risks from handler and applicator exposures were
    calculated for short-term and intermediate-term dermal and
    inhalation exposures. All exposure and risk estimates for
    occupational handler scenarios are below the Agency's level of
    concern. Therefore, no risk mitigation measures are required for
    these handler scenarios.

    **ii. Post-Application Risk Mitigation**

    Post-application exposure to re-entry workers is possible because
    4-t-amylphenol can be applied as a fogging application to animal
    buildings. The Agency used the MCCEM (Multi- Chamber Concentration
    and Exposure Model) to estimate postapplication/bystander exposures.
    The calculated inhalation MOEs were above the target MOE of 300 for
    all fogging postapplication scenarios with the exception of the
    scenario for 8-hr exposure to the product with a 2-hr reentry
    interval (MOE = 86).

The Agency does not believe that any mitigation is necessary to address
the post-application scenario with a 2-hr reentry interval at this time.
The risk estimate was calculated using the Agency's standard assumptions
for air exchange rates. The Agency believes that in the case of animal
barns and facilities this assumption is very conservative given the
relatively high air exchange rates for such facilities.

**2. Environmental Risk Management**

As the uses of 4-t-amylphenol considered in this RED make it unlikely
that any appreciable exposure to terrestrial or aquatic organisms would
occur, no risk mitigation measures are required to address environmental
exposure to 4-t-amylphenol.

**3. Other Labeling Requirements**

In order to be eligible for reregistration, various use and safety
information will be included in the labeling of all end-use products
containing 4-t-amylphenol. For the specific labeling statements and a
list of outstanding data, refer to Section V of this RED document.

**4.** **Listed Species Considerations**

**a. The Endangered Species Act**

[]{.mark}

Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2),
requires all federal agencies to consult with the National Marine
Fisheries Service (NMFS) for marine and anadromous listed species, or
the United States Fish and Wildlife Services (FWS) for listed wildlife
and freshwater organisms, if they are proposing an \"action\" that may
affect listed species or their designated habitat. Each federal agency
is required under the Act to insure that any action they authorize,
fund, or carry out is not likely to jeopardize the continued existence
of a listed species or result in the destruction or adverse modification
of designated critical habitat. To jeopardize the continued existence of
a listed species means \"to engage in an action that reasonably would be
expected, directly or indirectly, to reduce appreciably the likelihood
of both the survival and recovery of a listed species in the wild by
reducing the reproduction, numbers, or distribution of the species.\" 50
C.F.R. § 402.02.

To facilitate compliance with the requirements of the Endangered Species
Act subsection (a)(2) the Environmental Protection Agency, Office of
Pesticide Programs has established procedures to evaluate whether a
proposed registration action may directly or indirectly reduce
appreciably the likelihood of both the survival and recovery of a listed
species in the wild by reducing the reproduction, numbers, or
distribution of any listed species (U.S. EPA 2004). After the Agency's
screening-level risk assessment is performed, if any of the Agency's
Listed Species LOC Criteria are exceeded for either direct or indirect
effects, a determination is made to identify if any listed or
[candidate]{.mark} species may co-occur in the area of the proposed
pesticide use. If determined that listed or candidate species may be
present in the proposed use areas, further biological assessment is
undertaken. The extent to which listed species may be at risk then
determines the need for the development of a more comprehensive
consultation package as required by the Endangered Species Act.

For certain use categories, the Agency assumes there will be minimal
environmental exposure, and only a minimal toxicity data set is required
(Overview of the Ecological Risk Assessment Process in the Office of
Pesticide Programs U.S. Environmental Protection Agency - Endangered and
Threatened Species Effects Determinations, 1/23/04, Appendix A, Section
IIB, pg.81). Chemicals in these categories therefore do not undergo a
full screening-level risk assessment, and are considered to fall under a
"no effect" determination. Due to the low likelihood of exposure of
4-t-amylphenol, the Agency expects no effects to listed species or
critical habitat and therefore makes a \"No Effect\" determination for
this chemical.

**b. General Risk Mitigation**

4-t-Amylphenol end use products (EPs) may also contain other registered
pesticides. Although the Agency is not proposing any mitigation measures
for products containing 4-t-amylphenol specific to federally listed
threatened and endangered species, the Agency needs to address potential
risks from other end-use products. Therefore, the Agency requires that
users adopt all threatened and endangered species risk mitigation
measures for all active ingredients in the product. If a product
contains multiple active ingredients with conflicting threatened and
endangered species risk mitigation measures, the more stringent
measure(s) should be adopted.

**V. What Registrants Need to Do**

The Agency has determined that 4-t-amylphenol is eligible for
reregistration provided that: (i) additional data that the Agency
intends to require confirm this decision; and (ii) the risk mitigation
measures outlined in this document are adopted, and (iii) label
amendments are made to reflect these measures. To implement the risk
mitigation measures, the registrants must amend their product labeling
to incorporate the label statements set forth in the Label Changes
Summary Table in Section B below (Table 13). The additional data
requirements that the Agency intends to obtain will include, among other
things, submission of the following:

[For 4-t-amylphenol technical grade active ingredient
products]{.underline}, the registrant needs to submit the following
items:

**Within 90 days from receipt of the generic data call in (DCI):**

1\. completed response forms to the generic DCI (i.e., DCI response form
and requirements status and registrant's response form); and

2\. submit any time extension and/or waiver requests with a full written
justification.

**Within the time limit specified in the generic DCI:**

1\. cite any existing generic data which address data requirements or
submit new generic data responding to the DCI.

Please contact Killian Swift at (703) 308-6346 with questions regarding
generic reregistration.

By US mail: By express or courier service:

Document Processing Desk (DCI/SRRD) Document Processing Desk (DCI/SRRD)

Killian Swift Killian Swift

US EPA (7510C) Office of Pesticide Programs (7510C)

1200 Pennsylvania Ave., NW Room 266A, Crystal Mall 2

Washington, DC 20460 1801 S. Bell Street

Arlington, VA 22202

[For end use products containing the active ingredient
4-t-amylphenol]{.underline}, the registrant needs to submit the
following items for each product.

**Within 90 days from the receipt of the product-specific data call-in
(PDCI)**:

1\. completed response forms to the PDCI (i.e., PDCI response form and
requirements status and registrant's response form); and

2\. submit any time extension or waiver requests with a full written
justification.

**Within eight months from the receipt of the PDCI:**

1\. two copies of the confidential statement of formula (EPA Form
8570-4);

2\. a completed original application for reregistration (EPA Form
8570-1). Indicate on the form that it is an "application for
reregistration";

3\. five copies of the draft label incorporating all label amendments
outlined in Table 13 of this document;

4\. a completed form certifying compliance with data compensation
requirements (EPA Form 8570-34); and

5\. if applicable, a completed form certifying compliance with cost
share offer requirements (EPA Form 8570-32); and

6\. the product-specific data responding to the PDCI.

Please contact Adam Heyward at (703) 308-6422 with questions regarding
product reregistration and/or the PDCI. All materials submitted in
response to the PDCI should be addressed as follows:

By US mail: By express or courier service:

Document Processing Desk (PDCI/PRB) Document Processing Desk (PDCI/PRB)

Adam Heyward Adam Heyward

US EPA (7510C) Office of Pesticide Programs (7510C)

1200 Pennsylvania Ave., NW Room 266A, Crystal Mall 2

Washington, DC 20460 1801 South Bell Street

Arlington, VA 22202

**A. Manufacturing Use Products**

**1. Additional Generic Data Requirements**

The generic database supporting the reregistration of 4-t-amylphenol has
been reviewed and determined to be substantially complete. However, the
following additional data requirements have been identified by the
Agency as confirmatory and included in the generic DCI for this RED.

The Agency has established an interim two-tiered system for toxicology
testing requirements. Tier I toxicology data requirements would apply to
all indirect food additives that result in residue concentrations
ranging from 0-200ppb which applies to 4-t amylphenol. The requirements
would consist of an acute toxicity testing battery, subchronic toxicity
studies in the rodent, a developmental toxicity study in the rat, and a
mutagenicity testing battery. The developmental toxicity study in the
rat, mutagenicity testing battery, the acute oral toxicity and the acute
dermal irritation data requirements has been fulfilled for 4-t
amylphenol. The Agency also conducts a literature search and can also
conduct a Structural Activity Relationship analysis (SAR) if
appropriate. The Agency also will hold in reserve a two-generation
reproduction toxicity study in the rat and a subchronic toxicity studies
in a non-rodent which would become data requirements if warranted by the
Agency's evaluation of the Tier 1 data. A 2-generation reproduction
study and a subchronic toxicity study in a non-rodent are being held in
reserve for 4-t amylphenol.

Tier II studies would be triggered by the presence of significant (i.e.
\>200ppb) residues in food or evidence of significant toxicity from the
Tier I data set, which may include developmental / reproductive, or
other systemic toxicity such as presence of neoplastic growth or
significant target organ toxicity. In such cases, chronic toxicity and
carcinogenicity testing would be required.

As mentioned earlier, the Agency assumed that food can contact 2000
cm^2^ of treated surfaces, and that 10% of the pesticide migrates to
food based on the Agency Residential SOPs in its dietary risk
assessment. The use of the 10% transfer rate instead of the use of a
100% transfer rate that is used in the FDA Sanitizer Solution Guidelines
requires the submission of confirmatory data to establish the
reliability of the use of the10% transfer rate.

The Agency is also holding in reserve a developmental toxicity study in
rabbits based on the potential endocrine disruption effects of this
chemical. The need for this study will be determined following the
Agency's review of the 90-day oral study in rodents.

The risk assessment noted deficiencies in the surrogate dermal and
inhalation exposure data available from the Chemical Manufacturers
Association (CMA) data base. Therefore, the Agency is requiring
confirmatory data to support the uses assessed with the CMA exposure
data within this risk assessment. The risk assessment also noted that
many of the use parameters (e.g., amount handled and duration of use)
were based on professional judgments. Therefore, descriptions of human
activities associated with the uses assessed are required as
confirmatory.

A 28-day rat inhalation study for hazard considerations because
4-t-amylphenol is an air deodorizer was considered, however, the Agency
does not believe this study is necessary because the MOEs are
sufficiently high for this use, and thus not of concern. In addition,
the Agency believes the repeat dermal toxicity study with end use
formulation product, and confirmatory residue migration data are not
necessary because the diaper and textile use are no longer eligible for
registration.

**Table 12. Confirmatory Data Requirements for Reregistration**

  ----------------------------------------------------------------------------
  **Guideline Study Name**             **New OPPTS     **Old Guideline No.**
                                       Guideline No.** 
  ------------------------------------ --------------- -----------------------
  90-day Oral Subchronic in Rats       870-3100        82-1
  (including neurotoxicity and                         
  endocrine endpoints)                                 

  Acute Dermal Toxicity                870.1200        81-2

  Acute Inhalation Toxicity            870.1300        81-3

  Acute Eye Irritation                 870.2400        81-4

  Skin Sensitization                   870.2600        81-6

  Dermal Indoor Exposure               875.1200,       233 and 236
                                       875.1600        

  Inhalation Indoor Exposure           875.1400,       234 and 236
                                       875.1600        

  Descriptions of Human Activity       875.2800        133-1

  Avian acute oral toxicity            850.2100        71-1

  Freshwater fish acute toxicity       850.1075        72-1

  Freshwater invertebrate acute        850.1010        72-2
  toxicity                                             

  Dietary-Residues in Food from        Non-Guideline   Non-Guideline
  Treating Countertops with 4-t                        
  amylphenol (FDA Wipe Study                           
  Methodology) (FDA, 2003a and 2003b)                  

  **Studies Held in Reserve**                          

  2-Generation Reproduction            870.3800        83-4

  90-day Oral Subchronic in            870-3150        82-1
  Non-Rodents                                          

  Developmental Toxicity in Rabbits    870.3700b       83-3b
  ----------------------------------------------------------------------------

**2. Labeling for Technical and Manufacturing Use Products**

To ensure compliance with FIFRA, technical and manufacturing use product
(MP) labeling should be revised to comply with all current EPA
regulations, PR Notices and applicable policies. The Technical and MP
labeling should bear the labeling contained in Table 13 , Label Changes
Summary Table.

**B. End-Use Products**

**1. Additional Product-Specific Data Requirements**

Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of
eligibility has been made. The Registrant must review previous data
submissions to ensure that they meet current EPA acceptance criteria and
if not, commit to conduct new studies. If a registrant believes that
previously submitted data meet current testing standards, then the study
MRID numbers should be cited according to the instructions in the
Requirement Status and Registrants Response Form provided for each
product.

A product-specific data call-in, outlining specific data requirements,
will follow this RED.

**2. Labeling for End-Use Products**

Labeling changes are necessary to implement measures outlined in Section
IV above. Specific language to incorporate these changes is specified in
Table 13.

Registrants may generally distribute and sell products bearing old
labels/labeling for 26 months from the date of the issuance of this
Reregistration Eligibility Decision document. Persons other than the
registrant may generally distribute or sell such products for 52 months
from the approval of labels reflecting the mitigation described in this
RED. However, existing stocks time frames will be established
case-by-case, depending on the number of products involved, the number
of label changes, and other factors. Refer to "Existing Stocks of
Pesticide Products; Statement of Policy," *Federal Register*, Volume 56,
No. 123, June 26, 1991.

**a. Label Changes Summary Table**

In order to be eligible for reregistration, amend all product labels to
incorporate the risk mitigation measures outlined in Section IV. The
following table describes how language on the labels should be amended.

**Table 13. Labeling Changes Summary Table**

  ----------------- ------------------------------------------- ------------
  Summary of                                                    
  Labeling Changes                                              
  for                                                           
  4-t-Amylphenol                                                
  and its Salts                                                 

  Description       Amended Labeling Language                   Placement on
                                                                Label

  Delete use on                                                 Use
  diapers                                                       Directions

  Delete all use on                                             Use
  non-laundered                                                 Directions
  textiles\\items                                               
  including                                                     
  mattresses,                                                   
  helmets,                                                      
  headgear,                                                     
  headphones,                                                   
  facegear, and                                                 
  mouthpieces.                                                  

  Laundry Use       Clarify language to ensure use requires     Use
                    washing and rinsing prior to wearing        Directions
                    clothing                                    
  ----------------- ------------------------------------------- ------------

**VI. APPENDICES**

**Appendix A: Use Patterns Eligible for Reregistration**

**4-T-Amylphenol**

+-------------+-------+--------+--------------+-----------------------+
| **Use       | **For | **     | *            | **Use Limitations**   |
| Site**      | mulat | Method | *Application |                       |
|             | ion** | of     | Rate/ No. of |                       |
|             |       | A      | ap           |                       |
|             |       | pplica | plications** |                       |
|             |       | tion** |              |                       |
+=============+=======+========+==============+=======================+
| \(1\)       |       |        |              |                       |
| **A         |       |        |              |                       |
| gricultural |       |        |              |                       |
| premises    |       |        |              |                       |
| and         |       |        |              |                       |
| equipment** |       |        |              |                       |
+-------------+-------+--------+--------------+-----------------------+
| Mushroom    | So    | Mop,   | 1 oz per     | **Use as a premises   |
| h           | luble | cloth, | gallon of    | spray, do not apply   |
| ouses-empty | co    | sponge | water        | to the crop, compost, |
| premise     | ncent | or     |              | or casing.**          |
| s/equipment | rate: | hand   | 1:128        |                       |
|             |       | t      | dilution     | Following application |
|             | Reg.2 | rigger |              | as a spray, do not    |
|             | 11-36 | s      | Thoroughly   | enter or allow others |
|             |       | prayer | wet for 10   | to enter the treated  |
|             |       |        | minutes      | area until sprays     |
|             |       |        | allow to air | have dries. Do not    |
|             |       |        | dry          | apply in a way that   |
|             |       |        |              | will contact workers  |
|             |       |        |              | or any other persons, |
|             |       |        |              | either directly or    |
|             |       |        |              | through drift. Only   |
|             |       |        |              | protected handlers    |
|             |       |        |              | may be in the area    |
|             |       |        |              | during the            |
|             |       |        |              | application. Do not   |
|             |       |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Mop,   | 1/2 oz per   | Following application |
|             | luble | cloth, | gallon of    | as a spray, do not    |
|             | co    | sponge | water        | enter or allow others |
|             | ncent | or     |              | to enter the treated  |
|             | rate: | hand   | 1:256        | area until sprays     |
|             |       | t      | dilution     | have dries. Do not    |
|             | Reg.  | rigger |              | apply in a way that   |
|             | 10    | s      | Thoroughly   | will contact workers  |
|             | 43-26 | prayer | wet for 10   | or any other persons, |
|             | Reg.2 |        | minutes      | either directly or    |
|             | 11-25 |        | allow to air | through drift. Only   |
|             |       |        | dry          | protected handlers    |
|             | R     |        |              | may be in the area    |
|             | eg.65 |        |              | during the            |
|             | 020-7 |        |              | application. Do not   |
|             |       |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
| Hard, non   | So    | Mop,   | 1 oz per     | Following application |
| porous, non | luble | cloth, | gallon of    | as a spray, do not    |
| food        | co    | sponge | water        | enter or allow others |
| contact     | ncent | or     |              | to enter the treated  |
| surfaces    | rate: | hand   | 1:128        | area until sprays     |
|             |       | t      | dilution     | have dries. Do not    |
|             | Reg.2 | rigger |              | apply in a way that   |
|             | 11-36 | s      | Thoroughly   | will contact workers  |
|             |       | prayer | wet for 10   | or any other persons, |
|             | R     |        | minutes      | either directly or    |
|             | eg.49 |        | allow to air | through drift. Only   |
|             | 403-6 |        | dry          | protected handlers    |
|             | Reg.  |        |              | may be in the area    |
|             | 104   |        |              | during the            |
|             | 3-118 |        |              | application. Do not   |
|             | R     |        |              | contaminate other     |
|             | eg.11 |        |              | materials (including  |
|             | 725-9 |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
| Agricu      | So    | Mop,   | 1 oz per     | **Do not use in       |
| ltural/farm | luble | cloth, | gallon of    | milking stalls.       |
| equ         | co    | sponge | water        | Milking parlors, or   |
| ipment/shoe | ncent | or     |              | milk houses. Do not   |
| baths       | rate: | hand   | 1:128        | apply to crop, soil   |
|             |       | t      | dilution     | or growing media in   |
| Agricu      | Reg.2 | rigger |              | which a crop grows or |
| ltural/farm | 11-36 | s      | Thoroughly   | will be** **growing** |
| equ         | R     | prayer | wet for 10   |                       |
| ipment/shoe | eg.49 |        | minutes      | Following application |
| baths       | 403-6 |        | allow to air | as a spray, do not    |
| *(          | Reg.  |        | dry          | enter or allow others |
| continued)* | 104   |        |              | to enter the treated  |
|             | 3-118 |        | \*\*Shoe     | area until sprays     |
|             |       |        | bath         | have dries. Do not    |
|             | Reg.  |        | sanitizer    | apply in a way that   |
|             | 66    |        | containing   | will contact workers  |
|             | 171-1 |        | one inch of  | or any other persons, |
|             | R     |        | freshly made | either directly or    |
|             | eg.11 |        | disinfectant | through drift. Only   |
|             | 725-9 |        | should be    | protected handlers    |
|             |       |        | placed at    | may be in the area    |
|             |       |        | all          | during the            |
|             |       |        | entrances    | application. Do not   |
|             |       |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Fogger | ½ oz per     | **Treated food        |
|             | luble | (wet   | gallon of    | contact surfaces must |
|             |       | mi     | water        | be thoroughly rinsed  |
|             | co    | sting) |              | with potable water    |
|             | ncent |        | 1:256        | prior to use.** Do    |
|             | rate: |        | dilution     | not apply in a way    |
|             |       |        |              | that will contact     |
|             | Reg.  |        | Set the      | workers or any other  |
|             | 11    |        | automatic    | persons, either       |
|             | 725-8 |        | timer on the | directly or through   |
|             | R     |        | fogger for 6 | drift. Only protected |
|             | eg.10 |        | minutes for  | handlers may be in    |
|             | 43-91 |        |              | the area during the   |
|             | R     |        | 1000cu.ft    | application. Do not   |
|             | eg.11 |        | and leave    | contaminate other     |
|             | 725-7 |        | the room.    | materials (including  |
|             | R     |        | Allow at     | foods/drinks/feeds/   |
|             | eg.10 |        | least 2      | water)                |
|             | 43-26 |        | hours before |                       |
|             | Reg.2 |        | entering a   |                       |
|             | 11-25 |        | room that    |                       |
|             |       |        | has been     |                       |
|             |       |        | fogged       |                       |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Mop,   | 1/2 oz per   | Following application |
|             | luble | cloth, | gallon of    | as a spray, do not    |
|             | co    | sponge | water        | enter or allow others |
|             | ncent | or     |              | to enter the treated  |
|             | rate: | hand   | 1:256        | area until sprays     |
|             |       | t      | dilution     | have dries. Do not    |
|             | R     | rigger |              | apply in a way that   |
|             | eg.66 | s      | Thoroughly   | will contact workers  |
|             | 171-1 | prayer | wet for 10   | or any other persons, |
|             |       |        | minutes      | either directly or    |
|             | Reg.  |        | allow to air | through drift. Only   |
|             | 11    |        | dry          | protected handlers    |
|             | 725-7 |        |              | may be in the area    |
|             | R     |        | \*\*Shoe     | during the            |
|             | eg.10 |        | bath         | application. Do not   |
|             | 43-26 |        | sanitizer    | contaminate other     |
|             | Reg.2 |        | containing   | materials (including  |
|             | 11-25 |        | one inch of  | foods/drinks/feeds/   |
|             |       |        | freshly made | water)                |
|             | R     |        | disinfectant |                       |
|             | eg.65 |        | should be    |                       |
|             | 020-7 |        | placed at    |                       |
|             |       |        | all          |                       |
|             | Re    |        | entrances    |                       |
|             | g.386 |        |              |                       |
|             | 2-180 |        |              |                       |
+-------------+-------+--------+--------------+-----------------------+
| \(2\)       |       |        |              |                       |
| **Food      |       |        |              |                       |
| handl       |       |        |              |                       |
| ing/storage |       |        |              |                       |
| est         |       |        |              |                       |
| ablishments |       |        |              |                       |
| premises    |       |        |              |                       |
| and         |       |        |              |                       |
| equipment** |       |        |              |                       |
+-------------+-------+--------+--------------+-----------------------+
| Hard, non   | Ready | Spray  | To           | Following application |
| porous, non | to    |        | disinfect:   | as a spray, do not    |
| food        | use   |        | Thoroughly   | enter or allow others |
| contact     | solu  |        | wet          | to enter the treated  |
| surfaces    | tion: |        | (saturate)   | area until sprays     |
|             |       |        | all surfaces | have dries. Do not    |
| Hard, non   | Re    |        | for 10       | apply in a way that   |
| porous, non | g.127 |        | minutes.     | will contact workers  |
| food        | 0-237 |        |              | or any other persons, |
| contact     | Reg.  |        |              | either directly or    |
| surfaces    | 100   |        |              | through drift. Only   |
| *(          | 8-105 |        |              | protected handlers    |
| continued*) |       |        |              | may be in the area    |
|             |       |        |              | during the            |
|             |       |        |              | application. Do not   |
|             |       |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Mop,   | 1/2 oz per   | Following application |
|             | luble | cloth, | gallon of    | as a spray, do not    |
|             | co    | sponge | water        | enter or allow others |
|             | ncent | or     |              | to enter the treated  |
|             | rate: | hand   | 1:256        | area until sprays     |
|             |       | t      | dilution     | have dries. Do not    |
|             | R     | rigger |              | apply in a way that   |
|             | eg.10 | s      | Thoroughly   | will contact workers  |
|             | 43-92 | prayer | wet for 10   | or any other persons, |
|             | R     |        | minutes      | either directly or    |
|             | eg.10 |        | allow to air | through drift. Only   |
|             | 43-91 |        | dry          | protected handlers    |
|             | R     |        |              | may be in the area    |
|             | eg.11 |        |              | during the            |
|             | 725-7 |        |              | application. Do not   |
|             |       |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
| Meat        | Ready | Spray  | To           | Following application |
| processing  | to    |        | disinfect:   | as a spray, do not    |
| plant       | use   |        | Thoroughly   | enter or allow others |
| premises    | solu  |        | wet          | to enter the treated  |
| (nonfood)   | tion: |        | (saturate)   | area until sprays     |
|             |       |        | all surfaces | have dries. Do not    |
|             | Reg   |        | for 10       | apply in a way that   |
|             | .1008 |        | minutes.     | will contact workers  |
|             | 8-105 |        |              | or any other persons, |
|             | Re    |        |              | either directly or    |
|             | g.127 |        |              | through drift. Only   |
|             | 0-237 |        |              | protected handlers    |
|             |       |        |              | may be in the area    |
|             |       |        |              | during the            |
|             |       |        |              | application. Do not   |
|             |       |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Mop,   | 1/2 oz per   | Following application |
|             | luble | cloth, | gallon of    | as a spray, do not    |
|             | co    | sponge | water        | enter or allow others |
|             | ncent | or     |              | to enter the treated  |
|             | rate: | hand   | 1:256        | area until sprays     |
|             |       | t      | dilution     | have dries. Do not    |
|             | R     | rigger |              | apply in a way that   |
|             | eg.11 | s      | Thoroughly   | will contact workers  |
|             | 725-7 | prayer | wet for 10   | or any other persons, |
|             |       |        | minutes      | either directly or    |
|             |       |        | allow to air | through drift. Only   |
|             |       |        | dry          | protected handlers    |
|             |       |        |              | may be in the area    |
|             |       |        |              | during the            |
|             |       |        |              | application. Do not   |
|             |       |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
| Poultry     | Ready | Spray  | To           | Following application |
| processing  | to    |        | disinfect:   | as a spray, do not    |
| plant       | use   |        | Thoroughly   | enter or allow others |
| premises    | solu  |        | wet          | to enter the treated  |
| (nonfood)   | tion: |        | (saturate)   | area until sprays     |
|             |       |        | all surfaces | have dries. Do not    |
| Poultry     | Reg   |        | for 10       | apply in a way that   |
| processing  | .1008 |        | minutes.     | will contact workers  |
| plant       | 8-105 |        |              | or any other persons, |
| premises    | Reg.  |        |              | either directly or    |
| (nonfood)   | 127   |        |              | through drift. Only   |
| *(          | 0-237 |        |              | protected handlers    |
| continued)* |       |        |              | may be in the area    |
|             |       |        |              | during the            |
|             |       |        |              | application. Do not   |
|             |       |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Mop,   | 1/2 oz per   | Following application |
|             | luble | cloth, | gallon of    | as a spray, do not    |
|             | co    | sponge | water        | enter or allow others |
|             | ncent | or     |              | to enter the treated  |
|             | rate: | hand   | 1:256        | area until sprays     |
|             |       | t      | dilution     | have dries. Do not    |
|             | Re    | rigger |              | apply in a way that   |
|             | g.494 | s      | Thoroughly   | will contact workers  |
|             | 03-23 | prayer | wet for 10   | or any other persons, |
|             | Reg.2 |        | minutes      | either directly or    |
|             | 11-25 |        | allow to air | through drift. Only   |
|             |       |        | dry          | protected handlers    |
|             |       |        |              | may be in the area    |
|             |       |        |              | during the            |
|             |       |        |              | application. Do not   |
|             |       |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
| Processi    | Ready | Spray  | To           | Following application |
| ng/handling | to    |        | disinfect:   | as a spray, do not    |
| equipment   | use   |        | Thoroughly   | enter or allow others |
| (nonfood)   | solu  |        | wet          | to enter the treated  |
|             | tion: |        | (saturate)   | area until sprays     |
|             |       |        | all surfaces | have dries. Do not    |
|             | Reg   |        | for 10       | apply in a way that   |
|             | .1008 |        | minutes.     | will contact workers  |
|             | 8-105 |        |              | or any other persons, |
|             | Reg.  |        |              | either directly or    |
|             | 127   |        |              | through drift. Only   |
|             | 0-237 |        |              | protected handlers    |
|             |       |        |              | may be in the area    |
|             |       |        |              | during the            |
|             |       |        |              | application. Do not   |
|             |       |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Mop,   | 1/2 oz per   | Following application |
|             | luble | cloth, | gallon of    | as a spray, do not    |
|             | co    | sponge | water        | enter or allow others |
|             | ncent | or     |              | to enter the treated  |
|             | rate: | hand   | 1:256        | area until sprays     |
|             |       | t      | dilution     | have dries. Do not    |
|             | R     | rigger |              | apply in a way that   |
|             | eg.11 | s      | Thoroughly   | will contact workers  |
|             | 725-7 | prayer | wet for 10   | or any other persons, |
|             |       |        | minutes      | either directly or    |
|             |       |        | allow to air | through drift. Only   |
|             |       |        | dry          | protected handlers    |
|             |       |        |              | may be in the area    |
|             |       |        |              | during the            |
|             |       |        |              | application. Do not   |
|             |       |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
| \(3\)       |       |        |              |                       |
| **          |       |        |              |                       |
| Commercial, |       |        |              |                       |
| in          |       |        |              |                       |
| stitutional |       |        |              |                       |
| and         |       |        |              |                       |
| industrial  |       |        |              |                       |
| premises    |       |        |              |                       |
| and         |       |        |              |                       |
| equipment** |       |        |              |                       |
+-------------+-------+--------+--------------+-----------------------+
| In          | Re    | Spray  | To           | Following application |
| stitutional | ady-t |        | disinfect:   | as a spray, do not    |
| premises    | o-use |        | Thoroughly   | enter or allow others |
|             | -solu |        | wet          | to enter the treated  |
| In          | tion: |        | (saturate)   | area until sprays     |
| stitutional |       |        | all surfaces | have dries. Do not    |
| premises    | R     |        | for 10       | apply in a way that   |
| *(          | eg.10 |        | minutes.     | will contact workers  |
| continued)* | 4319, |        |              | or any other persons, |
|             | Re    |        |              | either directly or    |
|             | g.444 |        |              | through drift. Only   |
|             | 46-67 |        |              | protected handlers    |
|             |       |        |              | may be in the area    |
|             | Reg   |        |              | during the            |
|             | .1008 |        |              | application. Do not   |
|             | 8-105 |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             | Reg.  |        |              | foods/drinks/feeds/   |
|             | 127   |        |              | water)                |
|             | 0-237 |        |              |                       |
|             |       |        |              |                       |
|             | R     |        |              |                       |
|             | eg.74 |        |              |                       |
|             | 05-51 |        |              |                       |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Fogger | ½ oz per     | **Treated food        |
|             | luble | (wet   | gallon of    | contact surfaces must |
|             | co    | mi     | water        | be thoroughly rinsed  |
|             | ncent | sting) |              | with potable water    |
|             | rate: |        | 1:256        | prior to use.** Do    |
|             |       |        | dilution     | not apply in a way    |
|             | Reg.  |        |              | that will contact     |
|             | 11    |        | Set the      | workers or any other  |
|             | 725-8 |        | automatic    | persons, either       |
|             | R     |        | timer on the | directly or through   |
|             | eg.10 |        | fogger for 6 | drift. Only protected |
|             | 43-91 |        | minutes for  | handlers may be in    |
|             |       |        |              | the area during the   |
|             |       |        | 1000cu.ft    | application. Do not   |
|             |       |        | and leave    | contaminate other     |
|             |       |        | the room.    | materials (including  |
|             |       |        | Allow at     | foods/drinks/feeds/   |
|             |       |        | least 2      | water)                |
|             |       |        | hours before |                       |
|             |       |        | entering a   |                       |
|             |       |        | room that    |                       |
|             |       |        | has been     |                       |
|             |       |        | fogged       |                       |
+-------------+-------+--------+--------------+-----------------------+
| Hard, non   | So    | Mop,   | 1/2 oz per   | Following application |
| porous, non | luble | cloth, | gallon of    | as a spray, do not    |
| food        | co    | sponge | water        | enter or allow others |
| contact     | ncent | or     |              | to enter the treated  |
| surfaces    | rate: | hand   | 1:256        | area until sprays     |
|             |       | t      | dilution     | have dries. Do not    |
| Hard, non   | R     | rigger |              | apply in a way that   |
| porous, non | eg.66 | s      | Thoroughly   | will contact workers  |
| food        | 171-1 | prayer | wet for 10   | or any other persons, |
| contact     | Reg.1 |        | minutes      | either directly or    |
| surfaces    | 17258 |        | allow to air | through drift. Only   |
| *(          |       |        | dry          | protected handlers    |
| continued)* | R     |        |              | may be in the area    |
|             | eg.10 |        |              | during the            |
|             | 43-91 |        |              | application. Do not   |
|             |       |        |              | contaminate other     |
|             | R     |        |              | materials (including  |
|             | eg,10 |        |              | foods/drinks/feeds/   |
|             | 43-92 |        |              | water)                |
|             | R     |        |              |                       |
|             | eg.66 |        |              |                       |
|             | 171-2 |        |              |                       |
|             | Reg.  |        |              |                       |
|             | 2     |        |              |                       |
|             | 11-25 |        |              |                       |
|             |       |        |              |                       |
|             | Re    |        |              |                       |
|             | g.386 |        |              |                       |
|             | 2-180 |        |              |                       |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Mop,   | 1 oz per     | Following application |
|             | luble | cloth, | gallon of    | as a spray, do not    |
|             | co    | sponge | water        | enter or allow others |
|             | ncent | or     |              | to enter the treated  |
|             | rate: | hand   | 1:128        | area until sprays     |
|             |       | t      | dilution     | have dries. Do not    |
|             | R     | rigger |              | apply in a way that   |
|             | eg.21 | s      | Thoroughly   | will contact workers  |
|             | 1-36, | prayer | wet for 10   | or any other persons, |
|             |       |        | minutes      | either directly or    |
|             | Re    |        | allow to air | through drift. Only   |
|             | g.104 |        | dry          | protected handlers    |
|             | 3-115 |        |              | may be in the area    |
|             | R     |        |              | during the            |
|             | eg.10 |        |              | application. Do not   |
|             | 43-87 |        |              | contaminate other     |
|             | Reg.2 |        |              | materials (including  |
|             | 212-5 |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
|             | R     |        |              |                       |
|             | eg.49 |        |              |                       |
|             | 403-6 |        |              |                       |
|             | Reg.  |        |              |                       |
|             | 104   |        |              |                       |
|             | 3-118 |        |              |                       |
|             | R     |        |              |                       |
|             | eg.11 |        |              |                       |
|             | 725-9 |        |              |                       |
+-------------+-------+--------+--------------+-----------------------+
|             | R     | Spray  | To           | Following application |
|             | eady- |        | disinfect:   | as a spray, do not    |
|             | to-us |        | Thoroughly   | enter or allow others |
|             | e-sol |        | wet          | to enter the treated  |
|             | ution |        | (saturate)   | area until sprays     |
|             |       |        | all surfaces | have dries. Do not    |
|             | Reg.  |        | for 10       | apply in a way that   |
|             | 10    |        | minutes.     | will contact workers  |
|             | 43-19 |        |              | or any other persons, |
|             |       |        |              | either directly or    |
|             | Re    |        |              | through drift. Only   |
|             | g.444 |        |              | protected handlers    |
|             | 46-67 |        |              | may be in the area    |
|             |       |        |              | during the            |
|             | Reg   |        |              | application. Do not   |
|             | .1008 |        |              | contaminate other     |
|             | 8-105 |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             | Re    |        |              | water)                |
|             | g.127 |        |              |                       |
|             | 0-237 |        |              |                       |
|             |       |        |              |                       |
|             | R     |        |              |                       |
|             | eg.74 |        |              |                       |
|             | 05-51 |        |              |                       |
|             |       |        |              |                       |
|             | R     |        |              |                       |
|             | eg.55 |        |              |                       |
|             | 195-3 |        |              |                       |
|             |       |        |              |                       |
|             | Re    |        |              |                       |
|             | g.386 |        |              |                       |
|             | 2-104 |        |              |                       |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Fogger | ½ oz per     | **Treated food        |
|             | luble | (wet   | gallon of    | contact surfaces must |
|             | co    | mi     | water        | be thoroughly rinsed  |
|             | ncent | sting) |              | with potable water    |
|             | rate: |        | 1:256        | prior to use.** Do    |
|             |       |        | dilution     | not apply in a way    |
|             | Reg.  |        |              | that will contact     |
|             | 11    |        | Set the      | workers or any other  |
|             | 725-8 |        | automatic    | persons, either       |
|             | R     |        | timer on the | directly or through   |
|             | eg.10 |        | fogger for 6 | drift. Only protected |
|             | 43-91 |        | minutes for  | handlers may be in    |
|             |       |        |              | the area during the   |
|             |       |        | 1000cu.ft    | application. Do not   |
|             |       |        | and leave    | contaminate other     |
|             |       |        | the room.    | materials (including  |
|             |       |        | Allow at     | foods/drinks/feeds/   |
|             |       |        | least 2      | water)                |
|             |       |        | hours before |                       |
|             |       |        | entering a   |                       |
|             |       |        | room that    |                       |
|             |       |        | has been     |                       |
|             |       |        | fogged       |                       |
+-------------+-------+--------+--------------+-----------------------+
| Bedside and | So    | Mop,   | 1/2 oz per   | Following application |
| office      | luble | cloth, | gallon of    | as a spray, do not    |
| furniture   | co    | sponge | water        | enter or allow others |
|             | ncent | or     |              | to enter the treated  |
| Bedside and | rate: | hand   | 1:256        | area until sprays     |
| office      |       | t      | dilution     | have dries. Do not    |
| furniture   | Re    | rigger |              | apply in a way that   |
| *(          | g.661 | s      | Thoroughly   | will contact workers  |
| continued)* | 71-1, | prayer | wet for 10   | or any other persons, |
|             |       |        | minutes      | either directly or    |
|             | Re    |        | allow to air | through drift. Only   |
|             | g.117 |        | dry          | protected handlers    |
|             | 25-8, |        |              | may be in the area    |
|             | Reg.  |        |              | during the            |
|             | 10    |        |              | application. Do not   |
|             | 43-92 |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             | Re    |        |              | foods/drinks/feeds/   |
|             | g.104 |        |              | water)                |
|             | 3-91, |        |              |                       |
|             | Re    |        |              |                       |
|             | g.661 |        |              |                       |
|             | 71-2, |        |              |                       |
|             | Reg.2 |        |              |                       |
|             | 11-25 |        |              |                       |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Mop,   | 1 oz per     | Following application |
|             | luble | cloth, | gallon of    | as a spray, do not    |
|             | co    | sponge | water        | enter or allow others |
|             | ncent | or     |              | to enter the treated  |
|             | rate: | hand   | 1:128        | area until sprays     |
|             |       | t      | dilution     | have dries. Do not    |
|             | Reg.2 | rigger |              | apply in a way that   |
|             | 11-36 | s      | Thoroughly   | will contact workers  |
|             |       | prayer | wet for 10   | or any other persons, |
|             | Re    |        | minutes      | either directly or    |
|             | g.104 |        | allow to air | through drift. Only   |
|             | 3-115 |        | dry          | protected handlers    |
|             | R     |        |              | may be in the area    |
|             | eg.10 |        |              | during the            |
|             | 43-87 |        |              | application. Do not   |
|             |       |        |              | contaminate other     |
|             | Reg.2 |        |              | materials (including  |
|             | 212-5 |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
|             | R     |        |              |                       |
|             | eg.49 |        |              |                       |
|             | 403-6 |        |              |                       |
|             | Reg.  |        |              |                       |
|             | 104   |        |              |                       |
|             | 3-118 |        |              |                       |
+-------------+-------+--------+--------------+-----------------------+
|             | I     | Wipe   | Thoroughly   | Do not reuse wipes    |
|             | mpreg |        | wet          |                       |
|             | nated |        | pre-cleaned  |                       |
|             | mater |        | surface with |                       |
|             | ial.: |        | a wipe and   |                       |
|             |       |        | allow to air |                       |
|             | R     |        | dry          |                       |
|             | eg.55 |        |              |                       |
|             | 195-4 |        |              |                       |
+-------------+-------+--------+--------------+-----------------------+
|             | Re    | Spray  | To           | Following application |
|             | ady-t |        | disinfect:   | as a spray, do not    |
|             | o-use |        | Thoroughly   | enter or allow others |
|             | -solu |        | wet          | to enter the treated  |
|             | tion: |        | (saturate)   | area until sprays     |
|             |       |        | all surfaces | have dries. Do not    |
|             | Reg.  |        | for 10       | apply in a way that   |
|             | 10    |        | minutes.     | will contact workers  |
|             | 43-19 |        |              | or any other persons, |
|             | Reg   |        |              | either directly or    |
|             | .4444 |        |              | through drift. Only   |
|             | 6-67, |        |              | protected handlers    |
|             |       |        |              | may be in the area    |
|             | Reg   |        |              | during the            |
|             | .1008 |        |              | application. Do not   |
|             | 8-105 |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
| Trash carts | Re    | Spray  | To           | Following application |
|             | ady-t |        | disinfect:   | as a spray, do not    |
|             | o-use |        | Thoroughly   | enter or allow others |
|             | -solu |        | wet          | to enter the treated  |
|             | tion: |        | (saturate)   | area until sprays     |
|             |       |        | all surfaces | have dries. Do not    |
|             | Reg.  |        | for 10       | apply in a way that   |
|             | 10    |        | minutes.     | will contact workers  |
|             | 43-19 |        |              | or any other persons, |
|             | Re    |        |              | either directly or    |
|             | g.444 |        |              | through drift. Only   |
|             | 46-67 |        |              | protected handlers    |
|             |       |        |              | may be in the area    |
|             | Reg   |        |              | during the            |
|             | .1008 |        |              | application. Do not   |
|             | 8-105 |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
| Telephones  | Re    | Spray  | To           | Following application |
|             | ady-t |        | disinfect:   | as a spray, do not    |
|             | o-use |        | Thoroughly   | enter or allow others |
|             | -solu |        | wet          | to enter the treated  |
|             | tion: |        | (saturate)   | area until sprays     |
|             |       |        | all surfaces | have dries. Do not    |
|             | Reg.  |        | for 10       | apply in a way that   |
|             | 10    |        | minutes.     | will contact workers  |
|             | 43-19 |        |              | or any other persons, |
|             | Re    |        |              | either directly or    |
|             | g.444 |        |              | through drift. Only   |
|             | 46-67 |        |              | protected handlers    |
|             |       |        |              | may be in the area    |
|             | Reg   |        |              | during the            |
|             | .1008 |        |              | application. Do not   |
|             | 8-105 |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
| Waste cans  | Re    | Spray  | To           | Following application |
| and laundry | ady-t |        | disinfect:   | as a spray, do not    |
| hampers     | o-use |        | Thoroughly   | enter or allow others |
|             | -solu |        | wet          | to enter the treated  |
|             | tion: |        | (saturate)   | area until sprays     |
|             |       |        | all surfaces | have dries. Do not    |
|             | Reg.  |        | for 10       | apply in a way that   |
|             | 10    |        | minutes.     | will contact workers  |
|             | 43-19 |        |              | or any other persons, |
|             | Re    |        |              | either directly or    |
|             | g.444 |        |              | through drift. Only   |
|             | 46-67 |        |              | protected handlers    |
|             |       |        |              | may be in the area    |
|             | Reg   |        |              | during the            |
|             | .1008 |        |              | application. Do not   |
|             | 8-105 |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
| Sinks       | Re    | Spray  | To           | Following application |
|             | ady-t |        | disinfect:   | as a spray, do not    |
|             | o-use |        | Thoroughly   | enter or allow others |
|             | -solu |        | wet          | to enter the treated  |
|             | tion: |        | (saturate)   | area until sprays     |
|             |       |        | all surfaces | have dries. Do not    |
|             | Reg.  |        | for 10       | apply in a way that   |
|             | 10    |        | minutes.     | will contact workers  |
|             | 43-19 |        |              | or any other persons, |
|             | Re    |        |              | either directly or    |
|             | g.444 |        |              | through drift. Only   |
|             | 46-67 |        |              | protected handlers    |
|             |       |        |              | may be in the area    |
|             | Reg   |        |              | during the            |
|             | .1008 |        |              | application. Do not   |
|             | 8-105 |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
| Carpet      | So    | Hot    | 1 oz per     | Test fibers for       |
| cleaning    | luble | water  | gallon of    | colorfastness before  |
|             | co    | extr   | water        | use. Apply diluted    |
|             | ncent | action |              | cleaner to            |
|             | rate: |        | Inject and   | inconspicuous area,   |
|             |       |        | extract as   | and rub with a white  |
|             | R     |        | you would    | cloth. If color       |
|             | eg.70 |        | with other   | transfers to cloth or |
|             | 263-7 |        | extraction   | changes, a water      |
|             |       |        | cleaners     | based cleaning system |
|             |       |        |              | should not be used.   |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Spin   | 4 oz per     | Test fibers for       |
|             | luble | bonnet | gallon of    | colorfastness before  |
|             | co    | cl     | water        | use. Apply diluted    |
|             | ncent | eaning |              | cleaner to            |
|             | rate: | (      | Spray on at  | inconspicuous area,   |
|             |       | spray) | a rate of    | and rub with a white  |
|             | R     |        | 200-300      | cloth. If color       |
|             | eg.70 |        | square feet  | transfers to cloth or |
|             | 263-7 |        | per gallon,  | changes, a water      |
|             |       |        | scrub with   | based cleaning system |
|             |       |        | rotary floor | should not be used.   |
|             |       |        | machine      |                       |
|             |       |        | equipped     |                       |
|             |       |        | with bonnet  |                       |
|             |       |        | or pad       |                       |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Imm    | Mix 2 oz per | Test fibers for       |
|             | luble | ersion | gallon of    | colorfastness before  |
|             | co    |        | water in a   | use. Apply diluted    |
|             | ncent |        | cleaning     | cleaner to            |
|             | rate: |        | tank.        | inconspicuous area,   |
|             |       |        | Immerse rug  | and rub with a white  |
|             | R     |        | in cleaning  | cloth. If color       |
|             | eg.70 |        | solution.    | transfers to cloth or |
|             | 263-7 |        |              | changes, a water      |
|             |       |        |              | based cleaning system |
|             |       |        |              | should not be used.   |
+-------------+-------+--------+--------------+-----------------------+
| **(4)       |       |        |              |                       |
| Residential |       |        |              |                       |
| and public  |       |        |              |                       |
| access      |       |        |              |                       |
| premises**  |       |        |              |                       |
+-------------+-------+--------+--------------+-----------------------+
| Househo     | Re    | Spray  | To           | Following application |
| ld/domestic | ady-t |        | disinfect:   | as a spray, do not    |
| dwelling    | o-use |        | Thoroughly   | enter or allow others |
|             | -solu |        | wet          | to enter the treated  |
|             | tion: |        | (saturate)   | area until sprays     |
|             |       |        | all surfaces | have dries. Do not    |
|             | Reg.  |        | for 10       | apply in a way that   |
|             | 10    |        | minutes.     | will contact workers  |
|             | 43-19 |        |              | or any other persons, |
|             | R     |        |              | either directly or    |
|             | eg.44 |        |              | through drift. Only   |
|             | 44667 |        |              | protected handlers    |
|             |       |        |              | may be in the area    |
|             | Reg   |        |              | during the            |
|             | .1008 |        |              | application. Do not   |
|             | 8-105 |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             | Re    |        |              | foods/drinks/feeds/   |
|             | g.100 |        |              | water)                |
|             | 8-104 |        |              |                       |
|             |       |        |              |                       |
|             | Re    |        |              |                       |
|             | g.127 |        |              |                       |
|             | 0-237 |        |              |                       |
+-------------+-------+--------+--------------+-----------------------+
| Carpet      | So    | Hot    | 1 oz per     | Test fibers for       |
| cleaning    | luble | water  | gallon of    | colorfastness before  |
|             | co    | extr   | water        | use. Apply diluted    |
| Carpet      | ncent | action |              | cleaner to            |
| cleaning    | rate: |        | Inject and   | inconspicuous area,   |
| *(          |       |        | extract as   | and rub with a white  |
| continued)* | R     |        | you would    | cloth. If color       |
|             | eg.70 |        | with other   | transfers to cloth or |
|             | 263-7 |        | extraction   | changes, a water      |
|             |       |        | cleaners     | based cleaning system |
|             |       |        |              | should not be used.   |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Spin   | 4 oz per     | Test fibers for       |
|             | luble | bonnet | gallon of    | colorfastness before  |
|             | co    | cl     | water        | use. Apply diluted    |
|             | ncent | eaning |              | cleaner to            |
|             | rate: | (      | Spray on at  | inconspicuous area,   |
|             |       | spray) | a rate of    | and rub with a white  |
|             | R     |        | 200-300      | cloth. If color       |
|             | eg.70 |        | square feet  | transfers to cloth or |
|             | 263-7 |        | per gallon,  | changes, a water      |
|             |       |        | scrub with   | based cleaning system |
|             |       |        | rotary floor | should not be used.   |
|             |       |        | machine      |                       |
|             |       |        | equipped     |                       |
|             |       |        | with bonnet  |                       |
|             |       |        | or pad       |                       |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Imm    | Mix 2 oz per | Test fibers for       |
|             | luble | ersion | gallon of    | colorfastness before  |
|             | co    |        | water in a   | use. Apply diluted    |
|             | ncent |        | cleaning     | cleaner to            |
|             | rate: |        | tank.        | inconspicuous area,   |
|             |       |        | Immerse rug  | and rub with a white  |
|             | R     |        | in cleaning  | cloth. If color       |
|             | eg.70 |        | solution.    | transfers to cloth or |
|             | 263-7 |        |              | changes, a water      |
|             |       |        |              | based cleaning system |
|             |       |        |              | should not be used.   |
+-------------+-------+--------+--------------+-----------------------+
| Hard, non   | Re    | Spray  | To           | Following application |
| porous, non | ady-t |        | disinfect:   | as a spray, do not    |
| food        | o-use |        | Thoroughly   | enter or allow others |
| contact     | -solu |        | wet          | to enter the treated  |
| surfaces    | tion: |        | (saturate)   | area until sprays     |
|             |       |        | all surfaces | have dries. Do not    |
|             | Reg.  |        | for 10       | apply in a way that   |
|             | 104   |        | minutes.     | will contact workers  |
|             | 3-19, |        |              | or any other persons, |
|             |       |        |              | either directly or    |
|             | Re    |        |              | through drift. Only   |
|             | g.444 |        |              | protected handlers    |
|             | 46-67 |        |              | may be in the area    |
|             |       |        |              | during the            |
|             | Reg   |        |              | application. Do not   |
|             | .1008 |        |              | contaminate other     |
|             | 8-105 |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             | Re    |        |              | water)                |
|             | g.100 |        |              |                       |
|             | 8-104 |        |              |                       |
|             |       |        |              |                       |
|             | Re    |        |              |                       |
|             | g.127 |        |              |                       |
|             | 0-237 |        |              |                       |
|             |       |        |              |                       |
|             | Re    |        |              |                       |
|             | g.386 |        |              |                       |
|             | 2-104 |        |              |                       |
+-------------+-------+--------+--------------+-----------------------+
| Animals     | So    | Mop,   | 1/2 oz per   | Following application |
| kenne       | luble | cloth, | gallon of    | as a spray, do not    |
| ls/sleeping | co    | sponge | water        | enter or allow others |
| quarters    | ncent | or     |              | to enter the treated  |
| (           | rate: | hand   | 1:256        | area until sprays     |
| commercial) |       | t      | dilution     | have dries. Do not    |
|             | R     | rigger |              | apply in a way that   |
|             | eg.30 | s      | Thoroughly   | will contact workers  |
|             | 3-225 | prayer | wet for 10   | or any other persons, |
|             |       |        | minutes      | either directly or    |
|             |       |        | allow to air | through drift. Only   |
|             |       |        | dry          | protected handlers    |
|             |       |        |              | may be in the area    |
|             |       |        |              | during the            |
|             |       |        |              | application. Do not   |
|             |       |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Mop,   | 1 oz per     | Following application |
|             | luble | cloth, | gallon of    | as a spray, do not    |
|             | co    | sponge | water        | enter or allow others |
|             | ncent | or     |              | to enter the treated  |
|             | rate: | hand   | 1:128        | area until sprays     |
|             |       | t      | dilution     | have dries. Do not    |
|             | Reg.  | rigger |              | apply in a way that   |
|             | 66    | s      | Thoroughly   | will contact workers  |
|             | 171-2 | prayer | wet for 10   | or any other persons, |
|             |       |        | minutes      | either directly or    |
|             |       |        | allow to air | through drift. Only   |
|             |       |        | dry          | protected handlers    |
|             |       |        |              | may be in the area    |
|             |       |        |              | during the            |
|             |       |        |              | application. Do not   |
|             |       |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
| **(5)       |       |        |              |                       |
| Medical     |       |        |              |                       |
| premises    |       |        |              |                       |
| and         |       |        |              |                       |
| equipment** |       |        |              |                       |
+-------------+-------+--------+--------------+-----------------------+
| Hospital    | Re    | Spray  | To           | Following application |
| non         | ady-t |        | disinfect:   | as a spray, do not    |
| critical    | o-use |        | Thoroughly   | enter or allow others |
| i           | -solu |        | wet          | to enter the treated  |
| tems(bedpan | tion: |        | (saturate)   | area until sprays     |
| s/furniture |       |        | all surfaces | have dries. Do not    |
|             | Reg.  |        | for 10       | apply in a way that   |
| Hospital    | 10    |        | minutes.     | will contact workers  |
| non         | 43-19 |        |              | or any other persons, |
| critical    | Re    |        |              | either directly or    |
| i           | g.444 |        |              | through drift. Only   |
| tems(bedpan | 46-67 |        |              | protected handlers    |
| s/furniture |       |        |              | may be in the area    |
| *(          | Reg   |        |              | during the            |
| continued)* | .1008 |        |              | application. Do not   |
|             | 8-105 |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             | R     |        |              | foods/drinks/feeds/   |
|             | eg.12 |        |              | water)                |
|             | 70237 |        |              |                       |
|             |       |        |              |                       |
|             | Reg   |        |              |                       |
|             | .1080 |        |              |                       |
|             | 7-177 |        |              |                       |
|             | Reg   |        |              |                       |
|             | .1080 |        |              |                       |
|             | 7-178 |        |              |                       |
|             | Re    |        |              |                       |
|             | g.386 |        |              |                       |
|             | 2-104 |        |              |                       |
|             |       |        |              |                       |
|             | Reg.7 |        |              |                       |
|             | 06-69 |        |              |                       |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Mop,   | 1/2 oz per   | Following application |
|             | luble | cloth, | gallon of    | as a spray, do not    |
|             | co    | sponge | water        | enter or allow others |
|             | ncent | or     |              | to enter the treated  |
|             | rate: | hand   | 1:256        | area until sprays     |
|             |       | t      | dilution     | have dries. Do not    |
|             | Reg.2 | rigger |              | apply in a way that   |
|             | 11-25 | s      | Thoroughly   | will contact workers  |
|             |       | prayer | wet for 10   | or any other persons, |
|             |       |        | minutes      | either directly or    |
|             |       |        | allow to air | through drift. Only   |
|             |       |        | dry          | protected handlers    |
|             |       |        |              | may be in the area    |
|             |       |        |              | during the            |
|             |       |        |              | application. Do not   |
|             |       |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Mop,   | 40cc per 2   | Following application |
|             | luble | cloth, | gallons of   | as a spray, do not    |
|             | co    | sponge | water        | enter or allow others |
|             | ncent | or     |              | to enter the treated  |
|             | rate: | hand   | 1:200        | area until sprays     |
|             |       | t      | dilution     | have dries. Do not    |
|             | Reg.6 | rigger |              | apply in a way that   |
|             | 75-21 | s      | Thoroughly   | will contact workers  |
|             |       | prayer | wet for 10   | or any other persons, |
|             |       |        | minutes      | either directly or    |
|             |       |        | allow to air | through drift. Only   |
|             |       |        | dry          | protected handlers    |
|             |       |        |              | may be in the area    |
|             |       |        |              | during the            |
|             |       |        |              | application. Do not   |
|             |       |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Mop,   | 1 oz per     | Following application |
|             | luble | cloth, | gallon of    | as a spray, do not    |
|             | co    | sponge | water        | enter or allow others |
|             | ncent | or     |              | to enter the treated  |
|             | rate: | hand   | 1:128        | area until sprays     |
|             |       | t      | dilution     | have dries. Do not    |
|             | Reg.2 | rigger |              | apply in a way that   |
|             | 11-36 | s      | Thoroughly   | will contact workers  |
|             |       | prayer | wet for 10   | or any other persons, |
|             | R     |        | minutes      | either directly or    |
|             | eg.49 |        | allow to air | through drift. Only   |
|             | 403-6 |        | dry          | protected handlers    |
|             |       |        |              | may be in the area    |
|             |       |        |              | during the            |
|             |       |        |              | application. Do not   |
|             |       |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
| Hospital    | So    | Mop,   | 1 oz per     | Following application |
| semi        | luble | cloth, | gallon of    | as a spray, do not    |
| critical    | co    | sponge | water        | enter or allow others |
| items       | ncent | or     |              | to enter the treated  |
|             | rate: | hand   | 1:128        | area until sprays     |
|             |       | t      | dilution     | have dries. Do not    |
|             | Reg.2 | rigger |              | apply in a way that   |
|             | 11-36 | s      | Thoroughly   | will contact workers  |
|             |       | prayer | wet for 10   | or any other persons, |
|             | R     |        | minutes      | either directly or    |
|             | eg.49 |        | allow to air | through drift. Only   |
|             | 403-6 |        | dry          | protected handlers    |
|             |       |        |              | may be in the area    |
|             |       |        | \*\*Prior to | during the            |
|             |       |        | s            | application. Do not   |
|             |       |        | terilization | contaminate other     |
|             |       |        | or high      | materials (including  |
|             |       |        | level        | foods/drinks/feeds/   |
|             |       |        | dec          | water)                |
|             |       |        | ontamination |                       |
+-------------+-------+--------+--------------+-----------------------+
| Hospital    | So    | Imm    | 2 oz per     | Do not apply in a way |
| critical    | luble | ersion | gallon of    | that will contact     |
| items       | co    |        | water        | workers or any other  |
| (surgical   | ncent |        |              | persons, either       |
| i           | rate: |        | 1:64         | directly or through   |
| nstruments/ |       |        | dilution     | drift. Only protected |
| pacemakers) | Re    |        |              | handlers may be in    |
|             | g.104 |        | Soak for a   | the area during the   |
| Hospital    | 3-114 |        | minimum of   | application. Do not   |
| critical    |       |        | 20 minutes   | contaminate other     |
| items       |       |        | to achieve   | materials (including  |
| (surgical   |       |        | interim      | foods/drinks/feeds/   |
| i           |       |        | instrument   | water)                |
| nstruments/ |       |        | dec          |                       |
| pacemakers) |       |        | ontamination |                       |
| *(          |       |        |              |                       |
| continued)* |       |        | \*\*Prior to |                       |
|             |       |        | s            |                       |
|             |       |        | terilization |                       |
|             |       |        | or high      |                       |
|             |       |        | level        |                       |
|             |       |        | dec          |                       |
|             |       |        | ontamination |                       |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Imm    | 5oz per 2    | Do not apply in a way |
|             | luble | ersion | gallons of   | that will contact     |
|             | co    |        | water        | workers or any other  |
|             | ncent |        |              | persons, either       |
|             | rate: |        | 2:100        | directly or through   |
|             |       |        | dilution     | drift. Only protected |
|             | Reg.6 |        |              | handlers may be in    |
|             | 75-21 |        | Soak for 15  | the area during the   |
|             |       |        | minutes to   | application. Do not   |
|             |       |        | achieve      | contaminate other     |
|             |       |        | interim      | materials (including  |
|             |       |        | instrument   | foods/drinks/feeds/   |
|             |       |        | deco         | water)                |
|             |       |        | ntamination, |                       |
|             |       |        | then immerse |                       |
|             |       |        | in 70%       |                       |
|             |       |        | alcohol for  |                       |
|             |       |        | one minute   |                       |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Ultra  | 1 oz per     | Do not apply in a way |
|             | luble | sonic  | gallon of    | that will contact     |
|             | co    | cl     | water        | workers or any other  |
|             | ncent | eaning |              | persons, either       |
|             | rate: | system | 1:128        | directly or through   |
|             |       |        | dilution     | drift. Do not         |
|             | Reg.  |        |              | contaminate other     |
|             | 221   |        | Fill the     | materials (including  |
|             | 2-170 |        | basket with  | foods/drinks/feeds/   |
|             |       |        | pre cleaned  | water)                |
|             |       |        | instruments, |                       |
|             |       |        | place cover  |                       |
|             |       |        | on machine   |                       |
|             |       |        | and run      |                       |
|             |       |        | cycle for 10 |                       |
|             |       |        | minutes      |                       |
|             |       |        |              |                       |
|             |       |        | \*\*Prior to |                       |
|             |       |        | s            |                       |
|             |       |        | terilization |                       |
|             |       |        | or high      |                       |
|             |       |        | level        |                       |
|             |       |        | dec          |                       |
|             |       |        | ontamination |                       |
+-------------+-------+--------+--------------+-----------------------+
| Hospi       | Ready | Spray  | To           | Following application |
| tal/medical | to    |        | disinfect:   | as a spray, do not    |
| i           | use   |        | Thoroughly   | enter or allow others |
| nstitutions | solu  |        | wet          | to enter the treated  |
| premises    | tion: |        | (saturate)   | area until sprays     |
|             |       |        | all surfaces | have dries. Do not    |
| (human/     | Re    |        | for 10       | apply in a way that   |
| veterinary) | g.740 |        | minutes.     | will contact workers  |
|             | 5-51, |        |              | or any other persons, |
| Hospi       | Re    |        |              | either directly or    |
| tal/medical | g.386 |        |              | through drift. Only   |
| i           | 2-104 |        |              | protected handlers    |
| nstitutions |       |        |              | may be in the area    |
| premises    | Reg.7 |        |              | during the            |
|             | 06-69 |        |              | application. Do not   |
| (human/     |       |        |              | contaminate other     |
| veterinary) |       |        |              | materials (including  |
| *(          |       |        |              | foods/drinks/feeds/   |
| continued*) |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Fogger | ½ oz per     | **Treated food        |
|             | luble | (wet   | gallon of    | contact surfaces must |
|             | co    | mi     | water        | be thoroughly rinsed  |
|             | ncent | sting) |              | with potable water    |
|             | rate: |        | 1:256        | prior to use.** Do    |
|             |       |        | dilution     | not apply in a way    |
|             | Reg.  |        |              | that will contact     |
|             | 11    |        | Set the      | workers or any other  |
|             | 725-8 |        | automatic    | persons, either       |
|             |       |        | timer on the | directly or through   |
|             |       |        | fogger for 6 | drift. Only protected |
|             |       |        | minutes for  | handlers may be in    |
|             |       |        |              | the area during the   |
|             |       |        | 1000cu.ft    | application. Do not   |
|             |       |        | and leave    | contaminate other     |
|             |       |        | the room.    | materials (including  |
|             |       |        | Allow at     | foods/drinks/feeds/   |
|             |       |        | least 2      | water)                |
|             |       |        | hours before |                       |
|             |       |        | entering a   |                       |
|             |       |        | room that    |                       |
|             |       |        | has been     |                       |
|             |       |        | fogged       |                       |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Mop,   | 1/2 oz per   | Following application |
|             | luble | cloth, | gallon of    | as a spray, do not    |
|             | co    | sponge | water        | enter or allow others |
|             | ncent | or     |              | to enter the treated  |
|             | rate: | hand   | 1:256        | area until sprays     |
|             |       | t      | dilution     | have dries. Do not    |
|             | R     | rigger |              | apply in a way that   |
|             | eg.66 | s      | Thoroughly   | will contact workers  |
|             | 171-1 | prayer | wet for 10   | or any other persons, |
|             | R     |        | minutes      | either directly or    |
|             | eg.10 |        | allow to air | through drift. Only   |
|             | 43-92 |        | dry          | protected handlers    |
|             | R     |        |              | may be in the area    |
|             | eg.11 |        |              | during the            |
|             | 725-8 |        |              | application. Do not   |
|             | R     |        |              | contaminate other     |
|             | eg.66 |        |              | materials (including  |
|             | 171-2 |        |              | foods/drinks/feeds/   |
|             | Reg.  |        |              | water)                |
|             | 494   |        |              |                       |
|             | 03-23 |        |              |                       |
|             | Reg.2 |        |              |                       |
|             | 11-25 |        |              |                       |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Mop,   | 1 oz per     | Following application |
|             | luble | cloth, | gallon of    | as a spray, do not    |
|             | co    | sponge | water        | enter or allow others |
|             | ncent | or     |              | to enter the treated  |
|             | rate: | hand   | 1:128        | area until sprays     |
|             |       | t      | dilution     | have dries. Do not    |
|             | Reg.2 | rigger |              | apply in a way that   |
|             | 11-36 | s      | Thoroughly   | will contact workers  |
|             |       | prayer | wet for 10   | or any other persons, |
|             | R     |        | minutes      | either directly or    |
|             | eg.10 |        | allow to air | through drift. Only   |
|             | 43-87 |        | dry          | protected handlers    |
|             | Re    |        |              | may be in the area    |
|             | g.104 |        |              | during the            |
|             | 3-115 |        |              | application. Do not   |
|             |       |        |              | contaminate other     |
|             | R     |        |              | materials (including  |
|             | eg.49 |        |              | foods/drinks/feeds/   |
|             | 403-6 |        |              | water)                |
|             | Reg.  |        |              |                       |
|             | 104   |        |              |                       |
|             | 3-118 |        |              |                       |
|             | R     |        |              |                       |
|             | eg.11 |        |              |                       |
|             | 725-9 |        |              |                       |
+-------------+-------+--------+--------------+-----------------------+
|             | I     | Wipe   | Thoroughly   | Do not reuse wipes    |
|             | mpreg |        | wet          |                       |
|             | nated |        | pre-cleaned  |                       |
|             | mater |        | surface with |                       |
|             | ial:. |        | a wipe and   |                       |
|             |       |        | allow to air |                       |
|             | R     |        | dry          |                       |
|             | eg.55 |        |              |                       |
|             | 195-4 |        |              |                       |
+-------------+-------+--------+--------------+-----------------------+
| Hard, non   | Re    | Spray  | To           | Following application |
| porous, non | ady-t |        | disinfect:   | as a spray, do not    |
| food        | o-use |        | Thoroughly   | enter or allow others |
| contact     | -solu |        | wet          | to enter the treated  |
| surfaces    | tion: |        | (saturate)   | area until sprays     |
|             |       |        | all surfaces | have dries. Do not    |
|             | Reg.  |        | for 10       | apply in a way that   |
|             | 10    |        | minutes.     | will contact workers  |
|             | 43-19 |        |              | or any other persons, |
|             | Re    |        |              | either directly or    |
|             | g.444 |        |              | through drift. Only   |
|             | 46-67 |        |              | protected handlers    |
|             |       |        |              | may be in the area    |
|             | Re    |        |              | during the            |
|             | g.100 |        |              | application. Do not   |
|             | 8-105 |        |              | contaminate other     |
|             | Re    |        |              | materials (including  |
|             | g.127 |        |              | foods/drinks/feeds/   |
|             | 02-37 |        |              | water)                |
|             |       |        |              |                       |
|             | Reg   |        |              |                       |
|             | .1080 |        |              |                       |
|             | 7-177 |        |              |                       |
|             |       |        |              |                       |
|             | Reg   |        |              |                       |
|             | .1080 |        |              |                       |
|             | 7-178 |        |              |                       |
|             |       |        |              |                       |
|             | R     |        |              |                       |
|             | eg.74 |        |              |                       |
|             | 05-51 |        |              |                       |
|             |       |        |              |                       |
|             | R     |        |              |                       |
|             | eg.55 |        |              |                       |
|             | 195-3 |        |              |                       |
|             |       |        |              |                       |
|             | Re    |        |              |                       |
|             | g.386 |        |              |                       |
|             | 2-104 |        |              |                       |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Mop,   | 1/2 oz per   | Following application |
|             | luble | cloth, | gallon of    | as a spray, do not    |
|             | co    | sponge | water        | enter or allow others |
|             | ncent | or     |              | to enter the treated  |
|             | rate: | hand   | 1:256        | area until sprays     |
|             |       | t      | dilution     | have dries. Do not    |
|             | R     | rigger |              | apply in a way that   |
|             | eg.11 | s      | Thoroughly   | will contact workers  |
|             | 725-8 | prayer | wet for 10   | or any other persons, |
|             | R     |        | minutes      | either directly or    |
|             | eg.66 |        | allow to air | through drift. Only   |
|             | 171-2 |        | dry          | protected handlers    |
|             | Reg.  |        |              | may be in the area    |
|             | 2     |        |              | during the            |
|             | 11-25 |        |              | application. Do not   |
|             |       |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Fogger | ½ oz per     | **Treated food        |
|             | luble | (wet   | gallon of    | contact surfaces must |
|             | co    | mi     | water        | be thoroughly rinsed  |
|             | ncent | sting) |              | with potable water    |
|             | rate: |        | 1:256        | prior to use.** Do    |
|             |       |        | dilution     | not apply in a way    |
|             | Reg.  |        |              | that will contact     |
|             | 11    |        | Set the      | workers or any other  |
|             | 725-8 |        | automatic    | persons, either       |
|             |       |        | timer on the | directly or through   |
|             |       |        | fogger for 6 | drift. Only protected |
|             |       |        | minutes for  | handlers may be in    |
|             |       |        |              | the area during the   |
|             |       |        | 1000cu.ft    | application. Do not   |
|             |       |        | and leave    | contaminate other     |
|             |       |        | the room.    | materials (including  |
|             |       |        | Allow at     | foods/drinks/feeds/   |
|             |       |        | least 2      | water)                |
|             |       |        | hours before |                       |
|             |       |        | entering a   |                       |
|             |       |        | room that    |                       |
|             |       |        | has been     |                       |
|             |       |        | fogged       |                       |
+-------------+-------+--------+--------------+-----------------------+
|             | I     | Wipe   | Thoroughly   | Do not reuse wipes    |
|             | mpreg |        | wet          |                       |
|             | nated |        | pre-cleaned  |                       |
|             | mate  |        | surface with |                       |
|             | rial: |        | a wipe and   |                       |
|             |       |        | allow to air |                       |
|             | R     |        | dry          |                       |
|             | eg.55 |        |              |                       |
|             | 195-4 |        |              |                       |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Mop,   | 1 oz per     | Following application |
|             | luble | cloth, | gallon of    | as a spray, do not    |
|             | co    | sponge | water        | enter or allow others |
|             | ncent | or     |              | to enter the treated  |
|             | rate: | hand   | 1:128        | area until sprays     |
|             |       | t      | dilution     | have dries. Do not    |
|             | Reg.2 | rigger |              | apply in a way that   |
|             | 11-36 | s      | Thoroughly   | will contact workers  |
|             |       | prayer | wet for 10   | or any other persons, |
|             | R     |        | minutes      | either directly or    |
|             | eg.10 |        | allow to air | through drift. Only   |
|             | 43-87 |        | dry          | protected handlers    |
|             | Re    |        |              | may be in the area    |
|             | g.104 |        |              | during the            |
|             | 3-115 |        |              | application. Do not   |
|             |       |        |              | contaminate other     |
|             | R     |        |              | materials (including  |
|             | eg.49 |        |              | foods/drinks/feeds/   |
|             | 403-6 |        |              | water)                |
|             | Reg.  |        |              |                       |
|             | 104   |        |              |                       |
|             | 3-118 |        |              |                       |
|             |       |        |              |                       |
|             | R     |        |              |                       |
|             | eg.11 |        |              |                       |
|             | 725-9 |        |              |                       |
+-------------+-------+--------+--------------+-----------------------+
| Household   | Re    | Spray  | To           | Following application |
| sickrooms   | ady-t |        | disinfect:   | as a spray, do not    |
| prem        | o-use |        | Thoroughly   | enter or allow others |
| ises/conten | -solu |        | wet          | to enter the treated  |
| ts/utensils | tion: |        | (saturate)   | area until sprays     |
|             |       |        | all surfaces | have dries. Do not    |
|             | Reg.  |        | for 10       | apply in a way that   |
|             | 10    |        | minutes.     | will contact workers  |
|             | 43-19 |        |              | or any other persons, |
|             | Re    |        |              | either directly or    |
|             | g.444 |        |              | through drift. Only   |
|             | 46-67 |        |              | protected handlers    |
|             |       |        |              | may be in the area    |
|             | Reg   |        |              | during the            |
|             | .1008 |        |              | application. Do not   |
|             | 8-105 |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             | Re    |        |              | foods/drinks/feeds/   |
|             | g.386 |        |              | water)                |
|             | 2-104 |        |              |                       |
+-------------+-------+--------+--------------+-----------------------+
| Mor         | Ready | Spray  | To           | Following application |
| gues/mortua | to    |        | disinfect:   | as a spray, do not    |
| ries/autops | use   |        | Thoroughly   | enter or allow others |
| y/embalming | solu  |        | wet          | to enter the treated  |
| equipment   | tion: |        | (saturate)   | area until sprays     |
|             |       |        | all surfaces | have dries. Do not    |
|             | Reg   |        | for 10       | apply in a way that   |
|             | .1008 |        | minutes.     | will contact workers  |
|             | 8-105 |        |              | or any other persons, |
|             |       |        |              | either directly or    |
|             |       |        |              | through drift. Only   |
|             |       |        |              | protected handlers    |
|             |       |        |              | may be in the area    |
|             |       |        |              | during the            |
|             |       |        |              | application. Do not   |
|             |       |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
| Mor         | Ready | Spray  | To           | Following application |
| gues/mortua | to    |        | disinfect:   | as a spray, do not    |
| ries/autops | use   |        | Thoroughly   | enter or allow others |
| y/embalming | sol   |        | wet          | to enter the treated  |
| room        | ution |        | (saturate)   | area until sprays     |
| premises    | :     |        | all surfaces | have dries. Do not    |
|             |       |        | for 10       | apply in a way that   |
|             | Reg   |        | minutes.     | will contact workers  |
|             | .1008 |        |              | or any other persons, |
|             | 8-105 |        |              | either directly or    |
|             |       |        |              | through drift. Only   |
|             |       |        |              | protected handlers    |
|             |       |        |              | may be in the area    |
|             |       |        |              | during the            |
|             |       |        |              | application. Do not   |
|             |       |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
| Ba          | Ready | Spray  | To           | Following application |
| rber/beauty | to    |        | disinfect:   | as a spray, do not    |
| shop        | use   |        | Thoroughly   | enter or allow others |
| instruments | solu  |        | wet          | to enter the treated  |
| and         | tion: |        | (saturate)   | area until sprays     |
| equipment   |       |        | all surfaces | have dries. Do not    |
|             | Reg   |        | for 10       | apply in a way that   |
|             | .1008 |        | minutes.     | will contact workers  |
|             | 8-105 |        |              | or any other persons, |
|             |       |        |              | either directly or    |
|             |       |        |              | through drift. Only   |
|             |       |        |              | protected handlers    |
|             |       |        |              | may be in the area    |
|             |       |        |              | during the            |
|             |       |        |              | application. Do not   |
|             |       |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Imm    | 1/2 oz per   | Following application |
|             | luble | ersion | gallon of    | as a spray, do not    |
|             | co    |        | water        | enter or allow others |
|             | ncent |        |              | to enter the treated  |
|             | rate: |        | 1:256        | area until sprays     |
|             |       |        | dilution     | have dries. Do not    |
|             | R     |        |              | apply in a way that   |
|             | eg.66 |        | Thoroughly   | will contact workers  |
|             | 171-1 |        | wet for 10   | or any other persons, |
|             |       |        | minutes      | either directly or    |
|             |       |        | allow to air | through drift. Only   |
|             |       |        | dry          | protected handlers    |
|             |       |        |              | may be in the area    |
|             |       |        |              | during the            |
|             |       |        |              | application. Do not   |
|             |       |        |              | contaminate other     |
|             |       |        |              | materials (including  |
|             |       |        |              | foods/drinks/feeds/   |
|             |       |        |              | water)                |
+-------------+-------+--------+--------------+-----------------------+
| Carpet      | So    | Hot    | 1 oz per     | Test fibers for       |
| cleaning    | luble | water  | gallon of    | colorfastness before  |
|             | co    | extr   | water        | use. Apply diluted    |
| Carpet      | ncent | action |              | cleaner to            |
| cleaning    | rate: |        | Inject and   | inconspicuous area,   |
| *(          |       |        | extract as   | and rub with a white  |
| continued)* | R     |        | you would    | cloth. If color       |
|             | eg.70 |        | with other   | transfers to cloth or |
|             | 263-7 |        | extraction   | changes, a water      |
|             |       |        | cleaners     | based cleaning system |
|             |       |        |              | should not be used.   |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Spin   | 4 oz per     | Test fibers for       |
|             | luble | bonnet | gallon of    | colorfastness before  |
|             | co    | cl     | water        | use. Apply diluted    |
|             | ncent | eaning |              | cleaner to            |
|             | rate: | (      | Spray on at  | inconspicuous area,   |
|             |       | spray) | a rate of    | and rub with a white  |
|             | R     |        | 200-300      | cloth. If color       |
|             | eg.70 |        | square feet  | transfers to cloth or |
|             | 263-7 |        | per gallon,  | changes, a water      |
|             |       |        | scrub with   | based cleaning system |
|             |       |        | rotary floor | should not be used.   |
|             |       |        | machine      |                       |
|             |       |        | equipped     |                       |
|             |       |        | with bonnet  |                       |
|             |       |        | or pad       |                       |
+-------------+-------+--------+--------------+-----------------------+
|             | So    | Imm    | Mix 2 oz per | Test fibers for       |
|             | luble | ersion | gallon of    | colorfastness before  |
|             | co    |        | water in a   | use. Apply diluted    |
|             | ncent |        | cleaning     | cleaner to            |
|             | rate: |        | tank.        | inconspicuous area,   |
|             |       |        | Immerse rug  | and rub with a white  |
|             | R     |        | in cleaning  | cloth. If color       |
|             | eg.70 |        | solution.    | transfers to cloth or |
|             | 263-7 |        |              | changes, a water      |
|             |       |        |              | based cleaning system |
|             |       |        |              | should not be used.   |
+-------------+-------+--------+--------------+-----------------------+

**APPENDIX B: Para-Tertiary Amylphenol Case 3016**

Appendix B lists the **generic** (not product specific) data
requirements which support the re-registration of Para-tertiary
Amylphenol. These requirements apply to Para-Tertiary Amylphenol in all
products, including data requirements for which a technical grade active
ingredient is the test substance. The data table is organized in the
following formats:

1\. **[Data Requirement]{.underline}** (Columns 1 and 2). The data
requirements are listed by Guideline Number. The first column lists the
new Part 158 Guideline numbers, and the second column lists the old Part
158 Guideline numbers. Each Guideline Number has an associated test
protocol set forth in the Pesticide Assessment Guidance, which are
available on the EPA website.

2.  **[Guideline Description]{.underline}** (Column 3). Identifies the
    guideline type.

    3\. **[Use Pattern]{.underline}** (Column 4). This column indicates
    the standard Antimicrobial Division use patterns categories for
    which the generic (not product specific) data requirements apply.
    The number designations are used in Appendix B.

    **(1) Agricultural premises and equipment**

    **(2) Food handling/ storage establishments premises and equipment**

    **(3) Commercial, institutional and industrial premises and
    equipment**

    **(4) Residential and public access premises**

    **(5) Medical premises and equipment**

    **(6) Human water systems**

    **(7) Materials preservatives**

    **(8) Industrial processes and water systems**

    **(9) Antifouling coatings**

    **(10) Wood preservatives**

    **(11) Swimming pools**

    **(12) Aquatic areas**

    3\. **[Bibliographic Citation]{.underline}** (Column 5). If the
    Agency has data in its files to support a specific generic Guideline
    requirement, this column will identity each study by a "Master
    Record Identification (MRID) number. The listed studies are
    considered "valid" and acceptable for satisfying the Guideline
    requirement. Refer to the Bibliography appendix for a complete
    citation of each study.

+--------+-------+----------------------------+------+-----------------+
| **DATA |       |                            |      | **CITATION(S)** |
| R      |       |                            |      |                 |
| EQUIRE |       |                            |      |                 |
| MENT** |       |                            |      |                 |
+========+=======+============================+======+=================+
| **New  | **Old | **Study Title**            | *    | **MRID Number** |
| Gui    | Guid  |                            | *Use |                 |
| deline | eline |                            | P    |                 |
| Nu     | Num   |                            | atte |                 |
| mber** | ber** |                            | rn** |                 |
+--------+-------+----------------------------+------+-----------------+
| **[P   |       |                            |      |                 |
| RODUCT |       |                            |      |                 |
| CHEMIS |       |                            |      |                 |
| TRY]{. |       |                            |      |                 |
| underl |       |                            |      |                 |
| ine}** |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 61-1  | Product Identity and       | All  | Data Gap        |
| 0.1550 |       | Composition                |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 61-2a | Starting Materials and     | All  | Data Gap        |
| 0.1600 |       | Manufacturing Process      |      |                 |
| 83     |       |                            |      |                 |
| 0.1620 |       |                            |      |                 |
|        |       |                            |      |                 |
| 83     |       |                            |      |                 |
| 0.1650 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 61-2b | Formation of Impurities    | All  | Data Gap        |
| 0.1670 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 62-1  | Preliminary Analysis       | All  | Data Gap        |
| 0.1700 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 62-2  | Certification of Limits    | All  | Data Gap        |
| 0.1750 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 62-3  | Analytical Method          | All  | Data Gap        |
| 0.1800 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 63-2  | Color                      | All  | Data Gap        |
| 0.6302 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 63-3  | Physical State             | All  | Data Gap        |
| 0.6303 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 63-4  | Odor                       | All  | Not Applicable  |
| 0.6304 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | None  | UV/Visible Absorption      | All  | Data Gap        |
| 0.7050 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 63-5  | Melting Point              | All  | Data Gap        |
| 0.7200 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 63-6  | Boiling Point              | All  | Not Applicable  |
| 0.7220 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 63-7  | Density                    | All  | Data Gap        |
| 0.7300 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 63-8  | Solubility                 | All  | Data Gap        |
| 0.7840 |       |                            |      |                 |
|        |       |                            |      |                 |
| 83     |       |                            |      |                 |
| 0.7860 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 63-9  | Vapor Pressure             | All  | Data Gap        |
| 0.7950 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 63-10 | Dissociation Constant in   | All  | Not Applicable  |
| 0.7370 |       | Water                      |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 63-11 | Partition Coefficient      | All  | Data Gap        |
| 0.7550 |       | (Octanol/Water)            |      |                 |
|        |       |                            |      |                 |
| 83     |       |                            |      |                 |
| 0.7560 |       |                            |      |                 |
|        |       |                            |      |                 |
| 83     |       |                            |      |                 |
| 0.7570 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 63-12 | pH                         | All  | Data Gap        |
| 0.7000 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 63-13 | Stability                  | All  | Data Gap        |
| 0.6313 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 63-14 | Oxidizing/Reducing Action  | All  | Not Applicable  |
| 0.6314 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 63-15 | Flammability               | All  | Data Gap        |
| 0.6315 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 63-16 | Explodability              | All  | Not Applicable  |
| 0.6316 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 63-17 | Storage Stability          | All  | Data Gap        |
| 0.6317 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 63-18 | Viscosity                  | All  | Not Applicable  |
| 0.7100 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 63-19 | Miscibility                | All  | Data Gap        |
| 0.6319 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 63-20 | Corrosion Characteristics  | All  | Not Applicable  |
| 0.6320 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 63-21 | Dielectric breakdown       | All  | Not Applicable  |
| 0.6321 |       | voltage                    |      |                 |
+--------+-------+----------------------------+------+-----------------+
| *      |       |                            |      |                 |
| *[ECOL |       |                            |      |                 |
| OGICAL |       |                            |      |                 |
| EFFE   |       |                            |      |                 |
| CTS]{. |       |                            |      |                 |
| underl |       |                            |      |                 |
| ine}** |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 85     | 71-1  | Avian Acute Oral Toxicity  | All  | Data Gap        |
| 0.2100 |       | Test (Quail/Duck)          |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 85     | 72-1  | Fish Acute Toxicity --     | All  | Data Gap        |
| 0.1075 |       | Freshwater (Rainbow Trout) |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 85     | 72-2  | Acute Aquatic Invertebrate | All  | Data Gap        |
| 0.1010 |       | Toxicity                   |      |                 |
+--------+-------+----------------------------+------+-----------------+
| **[T   |       |                            |      |                 |
| OXICOL |       |                            |      |                 |
| OGY]{. |       |                            |      |                 |
| underl |       |                            |      |                 |
| ine}** |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 87     | 81-1  | Acute Oral - Rat           | All  | 46616601        |
| 0.1100 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 87     | 81-2  | Acute Dermal - Rabbit      | All  | Data Gap        |
| 0.1200 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 87     | 81-3  | Acute Inhalation - Rat     | All  | Data Gap        |
| 0.1300 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 87     | 81-4  | Primary Eye Irritation -   | All  | Data Gap        |
| 0.2400 |       | Rabbit                     |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 87     | 81-5  | Primary Dermal             | All  | 46616602        |
| 0.2500 |       | Irritation - Rabbit        |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 87     | 81-6  | Dermal Sensitization       | All  | Data Gap        |
| 0.2600 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 87     | 82-1a | 90-Day Feeding-Rodent,     | All  | Data Gap        |
| 0.3100 |       | with modifications (See    |      |                 |
|        |       | RED)                       |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 87     | 82-2  | 21/28-Day Dermal           | All  | Not Applicable  |
| 0.3200 |       | Toxicity - Rat             |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 87     | 82-3  | 90-day Dermal Toxicity -   | All  | 42470301        |
| 0.3250 |       | Rodent                     |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 87     | 82-4  | 28/90-Day Inhalation - Rat | All  | waived          |
| 0.3465 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 87     | 83-3  | Developmental Toxicity     | All  | Data Gap        |
| 0.3700 |       | -Rat                       |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 870    | 83-3a | Prenatal Developmental in  | All  | 41920002,       |
| .3700a |       | Rodents                    |      | 41920001,       |
|        |       |                            |      | 42026801        |
+--------+-------+----------------------------+------+-----------------+
| 87     | 84-2  | Bacterial Reverse Mutation | All  | 41438401,       |
| 0.5265 |       | Assay                      |      | 41572701,       |
|        |       |                            |      | 41728801        |
+--------+-------+----------------------------+------+-----------------+
| 87     | 84-2  | Detection of gene          | All  | 41572701        |
| 0.5300 |       | mutations in somatic cells |      |                 |
|        |       | (CHO)                      |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 87     | 84-2  | Micronucleus Assay         | All  | 41710801        |
| 0.5385 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
|        |       | ***[Reserved               |      |                 |
|        |       | Studies]{.underline}***    |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 87     | 82-1b | 90-Day Oral Subchronic in  |      | Data Gap,       |
| 0.3150 |       | Non-Rodent                 |      | Reserved Study  |
+--------+-------+----------------------------+------+-----------------+
| 870    | 83-3b | Developmental Toxicity     |      | Data Gap,       |
| .3700b |       | -Rabbit                    |      | Reserved Study  |
+--------+-------+----------------------------+------+-----------------+
| 87     | 83-4  | Reproduction and Fertility |      | Data Gap,       |
| 0.3800 |       | Effects - 2 Generation     |      | Reserved Study  |
|        |       | Repro                      |      |                 |
+--------+-------+----------------------------+------+-----------------+
| **[    |       |                            |      |                 |
| OCCUPA |       |                            |      |                 |
| TIONAL |       |                            |      |                 |
| /RESID |       |                            |      |                 |
| ENTIAL |       |                            |      |                 |
| EXPOS  |       |                            |      |                 |
| URE]{. |       |                            |      |                 |
| underl |       |                            |      |                 |
| ine}** |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 87     | 133-1 | Descriptions of Human      | All  | Data Gap        |
| 5.2800 |       | Activity                   |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 87     | 23    | Dermal Indoor Exposure     | All  | Data Gap        |
| 5.1200 | 3/236 |                            |      |                 |
|        |       |                            |      |                 |
| 87     |       |                            |      |                 |
| 5.1600 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 87     | 23    | Inhalation Indoor Exposure | All  | Data Gap        |
| 5.1400 | 4/236 |                            |      |                 |
|        |       |                            |      |                 |
| 87     |       |                            |      |                 |
| 5.1600 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| **[E   |       |                            |      |                 |
| NVIRON |       |                            |      |                 |
| MENTAL |       |                            |      |                 |
| F      |       |                            |      |                 |
| ATE]{. |       |                            |      |                 |
| underl |       |                            |      |                 |
| ine}** |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| 83     | 161-1 | Hydrolysis                 | All  | Required        |
| 5.2120 |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| **     |       |                            |      |                 |
| [OTHER |       |                            |      |                 |
| DATA   |       |                            |      |                 |
| REQ    |       |                            |      |                 |
| UIREME |       |                            |      |                 |
| NTS]{. |       |                            |      |                 |
| underl |       |                            |      |                 |
| ine}** |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| []{    |       |                            |      |                 |
| .mark} |       |                            |      |                 |
+--------+-------+----------------------------+------+-----------------+
| FDA    | FDA   | Dietary-Residues in Food   | All  | Required        |
| Gui    | Guid  | from Treating hard         |      |                 |
| deline | eline | non-porous surfaces with   |      |                 |
| iden   |       | 4-t-Amylphenol (conducted  |      |                 |
| tified | ident | according to FDA guideline |      |                 |
| here   | ified | entitled "Recommendations  |      |                 |
|        | here  | for Chemistry Data for     |      |                 |
|        |       | Indirect Food Additive     |      |                 |
|        |       | Petitions.")               |      |                 |
+--------+-------+----------------------------+------+-----------------+

# Appendix C. Technical Support Documents

Additional documentation in support of this RED is maintained in the OPP
docket, located in room 119, Crystal Mall #2, 1801 Bell St., Arlington,
VA 22202. It is open Monday through Friday, excluding legal holidays,
from 8:30 AM to 4:00 PM.

The docket initially contained preliminary risk assessments and related
documents as of April 28, 2004. Sixty days later the first public
comment period closed. The EPA then considered comments and revised the
risk assessments.

All documents, in hard copy form, may be viewed in the OPP docket room
or downloaded or viewed via the Internet at the following site:
<http://www.epa.gov/edockets>

These documents include:

1.  4-t-Amylphenol: Report of the Antimicrobials Divisions's Toxicology
    Endpoint Selection Committee (ADTC), July 2005

2.  Toxicology Science Chapter for the Reregistration Eligibility
    Decision Document, From M. Ottley to K. Swift, July 2005 D316279

3.  Occupational and Residential Exposure Assessment for
    t-Tert-Amylphenol and Salts. S. Mostaghimi . May 2005. D316290

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4.  Product Chemistry of Para-Tertiary-Amylphenol,
    para-tertiary-amylphenol, sodium salt and para-tertiary-amylphenol,
    potassium salt. From A. N. Shamim to T. McMahon. D316275

5.  Environmental Fate Assessment of 4-tert-Amylphenol and its Potassium
    and Sodium salts for the Reregistration Eligibility Decision (RED)
    Document. From S. Gowda, Microbiologist to M. Hartman. May 2005,
    D316277

6.  Ecological Hazard and Environmental Risk Assessment for
    4-tert-amylphenol and salts to be included in the RED. D. Bays to A.
    Heyward and K. Swift. July 2005, D316278

7.  Incident Reports Associated with 4-tert-amylphenol. J. Chen. May
    2005, D3162

8.  Dietary Exposure Assessments for the Reregistration Eligibility
    Decision. R. Quick. July 2005. D316295.

    **Appendix D. Citations Considered to be Part of the Data Base
    Supporting the 4-t-amylphenol Reregistration Decision
    (Bibliography)**

    **[GUIDE TO APPENDIX D]{.underline}**

    1\. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations
    of all studies considered relevant by EPA in arriving at the
    positions and conclusions stated elsewhere in the 4-t-amylphenol
    Reregistration Eligibility Document. Primary sources for studies in
    this bibliography have been the body of data submitted to EPA and
    its predecessor agencies in support of past regulatory decisions.
    Selections from other sources including the published literature, in
    those instances where they have been considered, are included.

    2\. UNITS OF ENTRY. The unit of entry in this bibliography is called
    a "study." In the case of published materials, this corresponds
    closely to an article. In the case of unpublished materials
    submitted to the Agency, the Agency has sought to identify documents
    at a level parallel to the published article from within the
    typically larger volumes in which they were submitted. The resulting
    "studies" generally have a distinct title (or at least a single
    subject), can stand alone for purposes of review and can be
    described with a conventional bibliographic citation. The Agency has
    also attempted to unite basic documents and commentaries upon them,
    treating them as a single study.

    3\. IDENTIFICATION OF ENTRIES. The entries in this bibliography are
    sorted numerically by Master Record Identifier, or "MRID" number.
    This number is unique to the citation, and should be used whenever a
    specific reference is required. It is not related to the six-digit
    "Accession Number" which has been used to identify volumes of
    submitted studies (see paragraph 4(d)(4) below for further
    explanation). In a few cases, entries added to the bibliography late
    in the review may be preceded by a nine character temporary
    identifier. These entries are listed after all MRID entries. This
    temporary identifying number is also to be used whenever specific
    reference is needed.

    4\. FORM OF ENTRY. In addition to the Master Record Identifier
    (MRID), each entry consists of a citation containing standard
    elements followed, in the case of material submitted to EPA, by a
    description of the earliest known submission. Bibliographic
    conventions used reflect the standard of the American National
    Standards Institute (ANSI), expanded to provide for certain special
    needs.

    a\. Author. Whenever the author could confidently be identified, the
    Agency has chosen to show a personal author. When no individual was
    identified, the Agency has shown an identifiable laboratory or
    testing facility as the author. When no author or laboratory could
    be identified, the Agency has shown the first submitter as the
    author.

    b\. Document date. The date of the study is taken directly from the
    document. When the date is followed by a question mark, the
    bibliographer has deduced the date from the evidence contained in
    the document. When the date appears as (1999), the Agency was unable
    to determine or estimate the date of the document.

    c\. Title. In some cases, it has been necessary for the Agency
    bibliographers to create or enhance a document title. Any such
    editorial insertions are contained between square brackets.

    d\. Trailing parentheses. For studies submitted to the Agency in the
    past, the trailing parentheses include (in addition to any
    self-explanatory text) the following elements describing the
    earliest known submission:

    \(1\) Submission date. The date of the earliest known submission
    appears immediately following the word "received."

    \(2\) Administrative number. The next element immediately following
    the word "under" is the registration number, experimental use permit
    number, petition number, or other administrative number associated
    with the earliest known submission.

    \(3\) Submitter. The third element is the submitter. When authorship
    is defaulted to the submitter, this element is omitted.

    \(4\) Volume Identification (Accession Numbers). The final element
    in the trailing parentheses identifies the EPA accession number of
    the volume in which the original submission of the study appears.
    The six-digit accession number follows the symbol "CDL," which
    stands for "Company Data Library." This accession number is in turn
    followed by an alphabetic suffix which shows the relative position
    of the study within the volume.

BIBRA, Working Group (1990): Para-tertiary-Amylphenol. Toxicity Profile
BIBRA Toxicology International. 3pp.

MRID No. 41710801

Edwards, C. N. 1990. Assessment of Clastogenic Action on Bone Marrow
Erthrocytes in

the Micronucleus Test. Prepared by Life Science Research Ltd., Suffolk,
UK. Study No. 90/ NLL033.0533. Submitted by Nipa Laboratories, Inc.
Wilmington, DE.

MRID No. 41438401

May, K. 1990. Nipacide PTAP (para-tertiary amylphenol): Assessment of
Mutagenic Potential in Histidine Auxotrophs of *Salmonella typhimurium*.
Prepared by Life Science Research Ltd., Suffolk, UK. Study No. 90/0109.
Submitted by Nipa Laboratories, Inc. Wilmington, DE.

MRID No. 41572701

Lloyd, J. M. 1990. Investigation of Mutagenic Activity in the TK+/ -
Mouse Lymphoma Cell Mutation System. Prepared by Life Science Research
Ltd., Suffolk, UK. Study No. 90/NLL034/0395. Submitted by Nipa
Laboratories, Inc., Wilmington, DE.

MRID No. 41920002

Siglin, J. C. 1991. Nipacide PTAP, Teratology Study in Rats. Prepared by
Springborn Laboratories, Inc. Spencerville, OH. Study No. 3227.3.
Submitted by Nipa Laboratories, Inc., Wilmington, DE.

MRID No. 46616601

Tufnell, P. P. 1992. Phenol, 4-(1,1-dimethylpropyl): Acute Oral Toxicity
Test in the Rat. Prepared by Safepharm Laboratories Ltd., Derby U.K.,
Laboratory Test No. 47/2097. Submitted by Sandoz Chemicals Ltd.

MRID No. 46616602

Tufnell, P. P. 1992. Phenol, 4-(1,1-dimethylpropyl): Acute Dermal
Irritation Test in the Rabbit. Prepared by Safepharm Laboratories Ltd.,
Derby U.K., Laboratory Test No. 47/2098. Submitted by Sandoz Chemicals
Ltd.

Gimeno S., Komen, H., Venderbosch, P.W. and Bowner, T. (1997) Disruption
of sexual differentiation in genetic male carp (*Cyprinus carpio*)
exposed to an alkylphenol during different life stages. Enviro Sci.
Technol. 31(10): 2884-2890.

Gimeno S., Komen H., Venderbosch, P. W. and Bowner, T. (1998a):
Feminisation of young males of the common carp, *Cyprinus carpio*,
exposed to 4-ter-pentyphenol during sexual differentiation. Aquatic
Toxicology (Amsterdam) 43: 77-92.

Gimeno, S. Komen, H. Jobling S., Sumpter, J. and Bowner, T. (1998b):
Demasculinisation of sexually mature male carp, *Cyprinus carpio*,
exposed to 4-tert-amylphenol during Spermatogenesis. Aquatic Toxicology
(Amsterdam) 43: 93-109.

Hazard Substances Databank (HSDB). A Database of the National Library of
Medicine's TOXNET System.

Helwig, D. (2003) Personal Communication between D. Helwig (Johnson
Dirersey, Inc.) and K. Riley (Versar, Inc., November 11, 2003.

Holcombe, G. W., Phipps, G. L., Knuth, M. L. and Felhabert, T. (1984):
The acute toxicity of selected substituted phenols, benzenes and benzoic
acid ester to fathead minnows *Pimephales promelas*. Environ. Pollut.
Ser. A. Ecol. Biol. 35(4): 367-381.

McLeese, D.W. (1981). Lethality and accumulation of alkylphenols in
aquatic fauna. Chemosphere 10(7): 723.

Routledge, E. J. Sumpter, J. P. (1997) Structural features of
alkylphenolic chemicals associated with estrogenic activity. J. Biol.
Chem. 272(6): 3280-3288.

Russon, C.L., Bradbury, S.P., Broderius S. J., Hammermeister, R. A. and
Drummond, R. A. (1997) \[no title given\] environ. Toxicol. Chem.
16:948.

Smeets, J. M., Van, H. I., Giesey, J. P., Seinen, W., and van den, B. M.
(1999).\\

Soto, et. al.(1995). The E-SCREEN assay tool to identify estrogens: An
update on estrogenic environmental pollutants. Environ. Health Perspect.
103 (Suppl. 7): 113-122.

Stevenson, C.J. (1984): Environmentally induced vitililigo (leukoderma)
from depigmenting agents and chemicals. J. Toxicol. Cutaneous Ocul.
Toxicol. 3(3): 299-308.

USEPA. 1997. Exposure Factors Handbook. Volume I-II. Office of Research
and Development. Washington, D.C. EPA/600/P-995/002 Fa.

EPA, 1997. "Exposure Factors Handbook, Volume III: Activity Factors."
EPA/600/P-95/002Fe August 1997.

USEPA. 1998. PHED Surrogate Exposure Guide. Estimates of Worker Exposure
from the Pesticide Handler Exposure Database Version 1.1. Washington,
DC: U.S. Environmental Protection Agency.

USEPA. 1999. Evaluation of Chemical Manufacturers Association
Antimicrobial Exposure Assessment Study. Memorandum from Siroos
Mostaghimi, Ph.D., USEPA, to Julie Fairfax, USEPA. Dated November 4,
1999. DP Barcode D247642.

EPA, 1999. "Available Information on Assessing Exposure from Pesticides,
A User's Guide."

U.S. Environmental Protection Agency (EPA) 2001. Residential SOPs Policy
Update 12, EPA Office of Pesticide Programs -- Human Health Division.
Dated April 5, 2000.

U.S. Environmental Protection Agency (EPA). 2002. ECOTOX User Guide:
ECOTOXicology Database System. Version 3.0. Available:
<http://www.epa.gov/ecotox/>

USEPA. 2005. Product Chemistry of Para-Tertiary-Amylphenol (PC Code
064101), Para-Tertiary-Amylphenol, Sodium Salt (PC Code 064112), and
Para-Tertiary-Amylphenol, Potassium Salt (PC Code 064111). Memorandum
from A.Najm Shamim, Ph.D.,

USEPA.2005. the Estimation Programs Interface (EPI) Suite. Windows-based
suite of physical/chemical properties and environmental estimation
models developed by the US EPA's Office of Prevention, Pesticides and
Toxic Substances (OPTS) and Syracuse Research Institute (SRC)
<http://www.epa.gov/oppintr/exposure/docs/EPISuitedl.htm>

USEPA's Estimation of P/Chem Properties Program, EPS Suite.

FDA, 2003a. "Guidance For Industry: Preparation of Food Contact
Notifications and Food Additive Petitions for Food Contact Substances:
Chemistry Recommendations. Final Guidance."

FDA, 2003b. "Sanitizing Solutions: Chemistry Guidelines for Food
Additive Petitions." January, 1993.
<http://www.cfasan.fda.gov/~dms/opa-cg3a.html.> Last accessed June 9,
2003.

Whatman, 2005. Whatman Absorbent Sinks.

<http://www.whatman.com/products/?pageID=7.32.42>, Accessed March 2005.

Wysowski, D.K. et. al. (1978) Epidemic neonatal Hyperbilirubinemia and
use of phenolic disinfectant detergent. Pediatrics 61: 165-170.

Yamasaki, K. et., al. (1978). Immature rat uterotrophic assay of 18
chemicals and Hershberger assay of 30 chemicals. Toxicology 183: 93-115.

Zeiger, E., Anderson B., Haworth, S., Lawlor, T. and Mortelmans, K.
(198): Salmonella mutagenicity tests. 4. results from testing of 300
chemicals. Environ. Mol. Mutagen 11: 1-158.

**Appendix E. Generic Data Call-In**

The Agency intends to issue a Generic Data Call-In at a later date. See
Chapter V of the RED for a list of studies that the Agency plans to
require for 4-t-amylphenol.

**Appendix F. Product Specific Data Call-In**

The Agency intends to issue a Product Specific Data Call-In at a later
date.

**Appendix G. Batching of Products for Meeting Acute Toxicity Data
Requirements for Reregistration**

In an effort to reduce the time, resources and number of animals needed
to fulfill the acute toxicity data requirements for reregistration of
products containing 4-t-amylphenol as the active ingredient, the Agency
has batched products which can be considered similar for purposes of
acute toxicity. Factors considered in the sorting process include each
product\'s active and inert ingredients (identity, percent composition
and biological activity), type of formulation (e.g., emulsifiable
concentrate, aerosol, wettable powder, granular, etc.), and labeling
(e.g., signal word, use classification, precautionary labeling, etc.).
Note that the Agency is not describing batched products as
\"substantially similar\" since some products within a batch may not be
considered chemically similar or have identical use patterns.

Using available information, batching has been accomplished by the
process described in the preceding paragraph. Not with-standing the
batching process, the Agency reserves the right to require, at any time,
acute toxicity data for an individual product should the need arise.

Registrants of products within a batch may choose to cooperatively
generate, submit or cite a single battery of six acute toxicological
studies to represent all the products within that batch. It is the
registrants\' option to participate in the process with all other
registrants, only some of the other registrants, or only their own
products within a batch, or to generate all the required acute
toxicological studies for each of their own products. If a registrant
chooses to generate the data for a batch, he/she must use one of the
products within the batch as the test material. If a registrant chooses
to rely upon previously submitted acute toxicity data, he/she may do so
provided that the data base is complete and valid by today\'s standards
(see acceptance criteria attached), the formulation tested is considered
by EPA to be similar for acute toxicity, and the formulation has not
been significantly altered since submission and acceptance of the acute
toxicity data. Regardless of whether new data is generated or existing
data is referenced, registrants must clearly identify the test material
by EPA Registration Number. If more than one confidential statement of
formula (CSF) exists for a product, the registrant must indicate the
formulation actually tested by identifying the corresponding CSF.

In deciding how to meet the product specific data requirements,
registrants must follow the directions given in the Data Call-In Notice
and its attachments appended to the RED. The DCI Notice contains two
response forms which are to be completed and submitted to the Agency
within 90 days of receipt. The first form, \"Data Call-In Response,\"
asks whether the registrant will meet the data requirements for each
product. The second form, \"Requirements Status and Registrant\'s
Response,\" lists the product specific data required for each product,
including the standard six acute toxicity tests. A registrant who wishes
to participate in a batch must decide whether he/she will provide the
data or depend on someone else to do so. If a registrant supplies the
data to support a batch of products, he/she must select one of the
following options: Developing Data (Option 1), Submitting an Existing
Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an
Existing Study (Option 6). If a registrant depends on another\'s data,
he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share
(Option 3) or Citing an Existing Study (Option 6). If a registrant does
not want to participate in a batch, the choices are Options 1, 4, 5 or
6. However, a registrant should know that choosing not to participate in
a batch does not preclude other registrants in the batch from citing
his/her studies and offering to cost share (Option 3) those studies.

The batching information will be provided with the product-specific DCI

#### Appendix H. List of All Registrants To Be Sent the Generic Data Call-In

#### 

Clariant Corporation

**Appendix I. List of Available Related Documents and Electronically
Available Forms**

Pesticide Registration Forms are available at the following EPA internet
site:

<http://www.epa.gov/opprd001/forms/> .

Pesticide Registration Forms (These forms are in PDF format and require
the Acrobat reader)

#### 

#### Instructions

1\. Print out and complete the forms. (Note: Form numbers that are
bolded can be filled out on your computer then printed.)

2\. The completed form(s) should be submitted in hardcopy in accord with
the existing policy.

3\. Mail the forms, along with any additional documents necessary to
comply with EPA regulations covering your request, to the address below
for the Document Processing Desk.

DO NOT fax or e-mail any form containing 'Confidential Business
Information' or 'Sensitive Information.'

If you have any problems accessing these forms, please contact Nicole
Williams at (703) 308-5551 or by e-mail at
<williams.nicole@epamail.epa.gov>.

[The following Agency Pesticide Registration Forms are currently
available via the internet at the following locations:]{.underline}

  --------- --------------------------------- -----------------------------------------------------
  8570-1    Application for Pesticide         <http://www.epa.gov/opprd001/forms/8570-1.pdf>
            Registration/Amendment            

  8570-4    Confidential Statement of Formula <http://www.epa.gov/opprd001/forms/8570-4.pdf>

  8570-5    Notice of Supplemental            <http://www.epa.gov/opprd001/forms/8570-5.pdf>
            Registration of Distribution of a 
            Registered Pesticide Product      

  8570-17   Application for an Experimental   <http://www.epa.gov/opprd001/forms/8570-17.pdf>
            Use Permit                        

  8570-25   Application for/Notification of   <http://www.epa.gov/opprd001/forms/8570-25.pdf>
            State Registration of a Pesticide 
            To Meet a Special Local Need      

  8570-27   Formulator's Exemption Statement  <http://www.epa.gov/opprd001/forms/8570-27.pdf>

  8570-28   Certification of Compliance with  <http://www.epa.gov/opprd001/forms/8570-28.pdf>
            Data Gap Procedures               

  8570-30   Pesticide Registration            <http://www.epa.gov/opprd001/forms/8570-30.pdf>
            Maintenance Fee Filing            

  8570-32   Certification of Attempt to Enter <http://www.epa.gov/opprd001/forms/8570-32.pdf>
            into an Agreement with other      
            Registrants for Development of    
            Data                              

  8570-34   Certification with Respect to     <http://www.epa.gov/opppmsd1/PR_Notices/pr98-5.pdf>
            Citations of Data (in PR Notice   
            98-5)                             

  8570-35   Data Matrix (in PR Notice 98-5)   <http://www.epa.gov/opppmsd1/PR_Notices/pr98-5.pdf>

  8570-36   Summary of the Physical/Chemical  <http://www.epa.gov/opppmsd1/PR_Notices/pr98-1.pdf>
            Properties (in PR Notice 98-1)    

  8570-37   Self-Certification Statement for  <http://www.epa.gov/opppmsd1/PR_Notices/pr98-1.pdf>
            the Physical/Chemical Properties  
            (in PR Notice 98-1)               
  --------- --------------------------------- -----------------------------------------------------

**Pesticide Registration Kit**

[www.epa.gov/pesticides/registrationkit/](http://www.epa.gov/).

Dear Registrant:

For your convenience, we have assembled an online registration kit that
contains the following pertinent forms and information needed to
register a pesticide product with the U.S. Environmental Protection
Agency's Office of Pesticide Programs (OPP):

1\. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and
the Federal Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food
Quality Protection Act (FQPA) of 1996.

2\. Pesticide Registration (PR) Notices

a\. 83-3 Label Improvement Program---Storage and Disposal Statements

b\. 84-1 Clarification of Label Improvement Program

c\. 86-5 Standard Format for Data Submitted under FIFRA

d\. 87-1 Label Improvement Program for Pesticides Applied through
Irrigation Systems (Chemigation)

e\. 87-6 Inert Ingredients in Pesticide Products Policy Statement

f\. 90-1 Inert Ingredients in Pesticide Products; Revised Policy
Statement

g\. 95-2 Notifications, Non-notifications, and Minor Formulation
Amendments

h\. 98-1 Self Certification of Product Chemistry Data with Attachments
(This document is in PDF format and requires the Acrobat reader.)

Other PR Notices can be found at
<http://www.epa.gov/opppmsd1/PR_Notices>.

3\. Pesticide Product Registration Application Forms (These forms are in
PDF format and will require the Acrobat reader.)

a\. EPA Form No. 8570-1, Application for Pesticide
Registration/Amendment

b\. EPA Form No. 8570-4, Confidential Statement of Formula

c\. EPA Form No. 8570-27, Formulator's Exemption Statement

d\. EPA Form No. 8570-34, Certification with Respect to Citations of
Data

e\. EPA Form No. 8570-35, Data Matrix

4\. General Pesticide Information (Some of these forms are in PDF format
and will require the Acrobat reader.)

a\. Registration Division Personnel Contact List

b\. Biopesticides and Pollution Prevention Division (BPPD) Contacts

c\. Antimicrobials Division Organizational Structure/Contact List

d\. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data
Requirements (PDF format)

e\. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices
(PDF format)

f\. 40 CFR Part 158, Data Requirements for Registration (PDF format)

g\. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27,
1985)

Before submitting your application for registration, you may wish to
consult some additional sources of information. These include:

1\. The Office of Pesticide Programs' Web Site

2\. The booklet "General Information on Applying for Registration of
Pesticides in the United States", PB92-221811, available through the
National Technical Information Service (NTIS) at the following address:

National Technical Information Service (NTIS)

5285 Port Royal Road

Springfield, VA 22161

The telephone number for NTIS is (703) 605-6000. Please note that EPA is
currently in the process of updating this booklet to reflect the changes
in the registration program resulting from the passage of the FQPA and
the reorganization of the Office of Pesticide Programs. We anticipate
that this publication will become available during the Fall of 1998.

3\. The National Pesticide Information Retrieval System (NPIRS) of
Purdue University's Center for Environmental and Regulatory Information
Systems. This service does charge a fee for subscriptions and custom
searches. You can contact NPIRS by telephone at (765) 494-6614 or
through their Web site.

4\. The National Pesticide Telecommunications Network (NPTN) can provide
information on active ingredients, uses, toxicology, and chemistry of
pesticides. You can contact NPTN by telephone at (800) 858-7378 or
through their Web site: [http://npic.orst.edu](http://npic.orst.edu/) .

The Agency will return a notice of receipt of an application for
registration or amended registration, experimental use permit, or
amendment to a petition if the applicant or petitioner encloses with his
submission a stamped, self-addressed postcard. The postcard must contain
the following entries to be completed by OPP:

Date of receipt

EPA identifying number

Product Manager assignment

Other identifying information may be included by the applicant to link
the acknowledgment of receipt to the specific application submitted. EPA
will stamp the date of receipt and provide the EPA identifying File
Symbol or petition number for the new submission. The identifying number
should be used whenever you contact the Agency concerning an application
for registration, experimental use permit, or tolerance petition.

To assist us in ensuring that all data you have submitted for the
chemical are properly coded and assigned to your company, please include
a list of all synonyms, common and trade names, company experimental
codes, and other names which identify the chemical (including "blind"
codes used when a sample was submitted for testing by commercial or
academic facilities). Please provide a CAS number if one has been
assigned.