  SEQ CHAPTER \h \r 1 United States 			Prevention, Pesticides		December
2007

  Environmental Protection             and Toxic Substances

  Agency                                     (7510P)

Alkyl Amine Hydrochloride Summary Document: Registration Review

Alkyl Amine Hydrochloride Summary Document:

Registration Review

Registration Review: Initial Docket

December 2007

							Approved By:

							____________________

							Frank T. Sanders

							Director, Antimicrobials Division

Date:

____________________

TABLE OF CONTENTS

Alkyl Amine Hydrochloride Registration Review Team
Members………………	  4

I. Preliminary Work
Plan….……………………………………………………….
.	  5

II. Fact
Sheet…………………………………………………………
………………	 12

III. Glossary of Terms and Abbreviations	 15

IV. Appendix
A……………………………………………………………
…………	17

Alkyl Amine Hydrochloride Registration Review Team

Human   SEQ CHAPTER \h \r 1 Health & Environmental Effects

Srinivas Gowda

Nathan Mottl

Risk Management

Heather Garvie

Diane Isbell

Office of General Counsel

Phil Ross

I. PRELIMINARY WORK PLAN - ALKYL AMINE HYDROCHLORIDE

Introduction

The Food Quality Protection Act (FQPA) of 1996 amended the Federal
Fungicide Insecticide and Rodenticide Act (FIFRA) to mandate a new
program: registration review.  All pesticides distributed or sold in the
United States generally must be registered by EPA, based on scientific
data showing that they will not cause unreasonable risks to human
health, workers, or the environment when used as directed on product
labeling.  The new registration review program is intended to make sure
that, as the ability to assess and reduce risk evolves and as policies
and practices change, all registered pesticides continue to meet the
statutory standard of no unreasonable adverse effects.  Changes in
science, public policy, and pesticide use practices will occur over
time.  Through the new registration review program, the Agency
periodically reevaluates pesticides to make sure that as change occurs,
products in the marketplace can continue to be used safely.  Information
on this program is provided at:
http://www.epa.gov/oppsrrd1/registration_review/.

		The Agency has begun to implement the new registration review program
pursuant to FIFRA Section 3(g) and will review each registered pesticide
every 15 years to determine whether it continues to meet the FIFRA
standard for registration. The public phase of registration review
begins when the initial docket is opened for each case.  The docket is
the Agency’s opportunity to state what it knows about the pesticide
and what additional risk analyses and data or information it believes
are needed to make a registration review decision. Alkyl amine
hydrochloride is an antimicrobial pesticide used for material
preservative use sites such as: resins, paints, adhesives, printing inks
and dispersed colors, caulks, spackling, joint cements, sealants,
grouts, and wallboard compounds.

Risk Assessment Status & Anticipated Risk Assessment and Data Needs

Human Health Risk Assessment Status

	A Reregistration Eligibility Decision (RED) document for alkyl amine
hydrochloride was issued in 1992.  Occupational uses of this chemical
were qualitatively assessed and residential uses were not assessed.
Because of the limited nature of this risk assessment, a new human
health risk assessment will need to be conducted.  Based on the
registered uses of alkyl amine hydrochloride as a materials preservative
there is potential for residential and occupational exposure and risk.
Therefore, the Agency anticipates conducting a complete occupational and
residential human health exposure risk assessment for all alkyl amine
hydrochloride uses. For a detailed discussion of the anticipated human
health exposure and risk assessment needs please refer to the Summary of
Human Health Effects Data for Alkyl Amine Hydrochloride (Coco Alkyl
Amine Registration Review Case) Decision Document, dated October 25,
2007.

	In addition, no human health toxicity endpoints for the active
ingredient alkyl amine hydrochloride have been selected.  Consequently,
toxicity endpoints need to be established.

Dietary Exposure

A dietary risk assessment is not needed for alkyl amine hydrochloride
because it has no registered uses where it will come in direct contact
with food.  In addition, alkyl amine hydrochloride has no tolerances or
exemptions from tolerance in raw agricultural commodities or processed
food and feed products. Because there is an adhesive use for alkyl amine
hydrochloride and there are no use limitations stated on either of the
labels, there may be potential for indirect food contact.  During the
public comment period, the Agency may receive additional information
clarifying use patterns for alkyl amine hydrochloride.  Therefore, the
Agency may conduct a dietary risk assessment in the future.

Aggregate and Cumulative Exposure

Alkyl amine hydrochloride has no direct food or feed uses; therefore,
aggregate exposures are not being evaluated.  Because the Agency has not
yet determined whether alkyl amine hydrochloride has a common mechanism
with other compounds, a cumulative assessment will not be performed at
this time.

Occupational and Residential Exposure

 	Because the alkyl amine hydrochloride RED was completed prior to the
advent of FQPA in 1996, a residential assessment was not conducted.
However, a qualitative occupational assessment for alkyl amine
hydrochloride was conducted and the Agency concluded that when the
chemical was used with Personal Protective Equipment (PPE) as directed
by the label that the occupational risks to alkyl amine hydrochloride
would be minimal.  Since that time the Agency has identified new
exposure databases that can more adequately characterize specific
antimicrobial exposures.  For certain antimicrobial chemicals, exposures
to products such as paint may lead to risk concerns for both
occupational and residential handlers even when PPE label restrictions
are imposed.  It is for this reason that the Agency will now
quantitatively assess risk for alkyl amine hydrochloride.

At this time the Agency anticipates that short- and intermediate-term
dermal occupational assessments as well as an inhalation assessment will
be needed to assess exposure for open situations in manufacturing
settings for all material preservative uses.    In addition, short-term
dermal and inhalation residential assessments will be needed for the
paint use. Because occupational and residential post-application dermal
and inhalation exposures are expected to be minimal, the Agency does not
anticipate performing that type of assessment.

Anticipated Human Health Data Needs

	The Agency anticipates that the following data are needed to conduct a
complete human health exposure and risk assessment for all alkyl amine
hydrochloride uses.  Please refer to Appendix A of the Summary of Human
Health Effects Data for Alkyl Amine Hydrochloride (Coco Alkyl Amine
Registration Review Case) Decision Document for a detailed description
of the anticipated toxicity database needs and Appendix B of the same
document for a detailed description of the anticipated occupational and
residential applicator data needs.

Human Health Toxicity Data Needs for the AI:

 (GLN 870.3465) 90-Day Inhalation Toxicity-rat

Residential Applicator Exposure Data Needs

(GLN 875.1100) Dermal Outdoor Exposure

(GLN 875.1200) Dermal Indoor Exposure

(GLN 875.1300) Inhalation Outdoor Exposure

(GLN 875.1400) Inhalation Indoor Exposure

(GLN 875.1600) Data Reporting and Calculations

(GLN 875.1700) Product Use Information

Occupational Applicator Exposure Data Needs

(GLN 875.1100) Dermal Outdoor Exposure

(GLN 875.1200) Dermal Indoor Exposure

(GLN 875.1300) Inhalation Outdoor Exposure

(GLN 875.1400) Inhalation Indoor Exposure

(GLN 875.1600) Data Reporting and Calculations

(GLN 875.1700) Product Use Information

Anticipated Physical/ Chemical Property Data Needs

All product chemistry data requirements have been fulfilled for alkyl
amine hydrochloride.

Anticipated Environmental Fate Data Needs

	All uses of alkyl amine hydrochloride are considered indoor uses and
are not expected to result in environmental exposure.  Therefore, no
environmental fate data is needed.

Ecological Assessment Status and Anticipated Data Needs

Ecological risk assessments have not been conducted for alkyl amine
hydrochloride since there is no exterior exposure from its indoor use.
However, the Agency has reviewed four basic ecotoxicology studies for
alkyl amine hydrochloride and, although some of the studies were
deficient in their conduct, they were adequate to provide the Agency
with sufficient information to determine appropriate label precautions.
Based on its review, the Agency believes that no additional data or
assessment of the ecological risks is needed for alkyl amine
hydrochloride.

Based on indoor use patterns, low exposure levels, and low toxicity
potential of alkyl amine hydrochloride, the Agency expects that the
registered uses of alkyl amine hydrochloride will have “no effect”
(NE) on endangered or threatened terrestrial or aquatic species, or
their designated critical habitats as listed by the U.S. Fish and
Wildlife Service (USFWS) and the National Oceanic and Atmospheric
Administration (NOAA). However, EPA will review any comments made by the
public on this document and will conduct another environmental risk
assessment, if new information warrants such action.

Timeline

EPA has created the following estimated timeline for the completion of
the alkyl amine hydrochloride registration review.

Activities	Estimated Month/Year

Phase 1: Opening the docket

Open Public Comment Period for alkyl amine hydrochloride Docket
December 2007

Close Public Comment Period 	March 2008

Phase 2:  Case Development

Develop Final Work Plan (FWP)	May  2008 – June 2008

Issue DCI 	February 2009 –

March 2009

Data Submission	February 20111-

April 2011

Open Public Comment Period for Preliminary Risk Assessments 	August 2012
– October 2012

Close Public Comment Period	November  2012 – January 2013

Phase 3: Registration Review Decision

Open Public Comment Period for Proposed Reg. Review Decision 	February
2013 –

April 2013

Close Public Comment Period 	May  2013 – July 2013

Final Decision and Begin Post-Decision Follow-up	 2013

Total (years)	6

 Time-frames may change depending on the studies needed and the
development and approval of the Human Studies Review Board protocols for
the following studies:  residential and occupational applicator dermal
outdoor exposure (GLN 875.1100), dermal indoor exposure (GLN 875.1200),
inhalation outdoor exposure (GLN 875.1300) and inhalation indoor
exposure (GLN 875.1400).

Guidance for Commenters

The public is invited to comment on EPA’s preliminary registration
review work- plan and rationale.  The Agency will consider all comments
as well as any additional information or data provided in a timely
manner prior to issuing a final work plan for the alkyl amine
hydrochloride case.

Stakeholders are also specifically asked to provide available
information and data in the following areas:

Confirmation on the following label information:

Sites of application

Formulations

Application methods and equipment

Maximum application rates

Frequency of application, application intervals and maximum number of
applications

Geographic limitations on use

Use or potential use distribution

Use history

Usage/use information for non-agricultural uses (e.g., materials
preservation)

Typical application interval

State or local use restrictions

Ecological incidents (non-target plant damage and avian, fish,
reptilian, amphibian and mammalian mortalities) not already reported to
the Agency

Monitoring data

	Alkyl amine hydrochloride is not identified as a cause of impairment
for any water-bodies listed as impaired under section 303(d) of the
Clean Water Act, based on information provided at:   HYPERLINK
"http://oaspub.epa.gov/tmdl/waters_list.impairments?p_impid=3"
http://oaspub.epa.gov/tmdl/waters_list.impairments?p_impid=3 . The
Agency invites submission of water quality data for these chemicals.  To
the extent possible, data should conform to the quality standards in
Appendix A of the “OPP Standard Operating Procedure: Inclusion of
Impaired Water Body and Other Water Quality Data in OPP’s Registration
Review Risk Assessment and Management Process,” (  HYPERLINK
"http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm"
http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm ),
in order to ensure they can be used quantitatively or qualitatively in
pesticide risk assessments.

Through the registration review process, the Agency intends to solicit
information on trade irritants and, to the extent feasible, take steps
toward facilitating irritant resolution.  Growers and other stakeholders
are asked to comment on any trade irritant issues resulting from lack of
Maximum Residue Limits (MRLs) or disparities between U.S. tolerances and
MRLs in key export markets, providing as much specificity as possible
regarding the nature of the concern.

Environmental Justice

	EPA seeks to achieve environmental justice, the fair treatment and
meaningful involvement of all people, regardless of race, color,
national origin, or income, in the development, implementation, and
enforcement of environmental laws, regulations, and policies. To help
address potential environmental justice issues, the Agency seeks
information on any groups or segments of the population who, as a result
of their location, cultural practices, or other factors, may have
atypical, unusually high exposure to alkyl amine hydrochloride, compared
to the general population.  Please comment if you are aware of any
sub-populations that may have atypical, unusually high exposure compared
to the general population.

Structure Activity Relationships

EPA must rely upon information of appropriate quality and reliability
for each decision made by the Agency.  In the Office of Pesticide
Programs (OPP), the evaluation process for a pesticide chemical
traditionally begins with the applicant’s submission of a set of
studies conducted with the specific pesticide chemical of interest.  The
use of the results of such testing (measured data) is a logical,
scientifically rigorous process that identifies the physical, chemical,
and environmental fate properties of the pesticide, as well as the dose
and endpoints at which an adverse effect can occur in various animal
species.

Today, there is significant interest in alternative techniques, i.e.,
techniques other than data generation that could significantly inform
the Agency’s decision-making process.  Recently, OPP has made
increasing use of structure activity relationship (SAR) as part of its
regulatory decision-making process.  In the SAR process, a chemical's
molecular structure is compared to that of other chemicals for which
data are available.  These structural similarities are then used to make
predictive judgments about a chemical’s physical, chemical, and
biological properties.  Thus, the chemical’s physical, chemical, and
biological properties are a function of (or directly related to) the
chemical’s molecular structure.  Quantitative SAR is referred to as
QSAR.  To develop a QSAR, a selected set of measured data on a single
physical, chemical, or biological property is used to derive a model (an
equation) to predict the value of that property.

	Since SAR assessments and QSAR modeling are another set of tools that
are available to Agency scientists, OPP has begun a process shift that
envisions shifting from the current study-by-study approach to an
approach in which the use of predicted data, generated using validated
models, is considered along with information from open literature and
studies specifically generated under Part 158 requirements.  All
relevant information would be considered as part of a
weight-of-the-evidence evaluation.

At this time, EPA believes that for certain endpoints, especially
physical/chemical and fate properties, that SAR and QSAR might be
effectively utilized to fulfill these data requirements for many
antimicrobial pesticide chemicals.  When considering biological
properties, at this time, EPA believes that SAR and QSAR can be most
effectively utilized in the evaluation of chemicals that exhibit lower
toxicity for human health and/or ecotoxicity parameters.  This is
appropriate because the risk assessment for lower toxicity chemicals can
be stream-lined, i.e., a screening-level assessment procedure rather
than multiple tiers of assessments with progressively more data
requirements.

If stakeholders believe that submission of predicted data can fulfill
one of the data needs for alkyl amine hydrochloride, then the Agency
invites submission of this information.  The submitter would be expected
to supply a rationale describing the utility of the information and
provide documentation on the scientific validity of the information.
The determination that the predicted data fulfills the data requirement
would be at the sole discretion of the Agency.  Pre-submission
consultation with the Agency is encouraged.

Next Steps

After the 90-day comment period closes in March 2008, the Agency will
prepare a Final Work Plan for this pesticide.

II. FACT SHEET

Background Information

Alkyl amine hydrochloride registration review case number: 3051

Alkyl amine hydrochloride PC Code: 069152

Alkyl amine hydrochloride CAS#: 91745-52-7

Technical registrant: International Specialty Products

First approved for use in a registered product: September, 1971

Reregistration Eligibility Decision (RED) document issued in 1992.

Antimicrobials Division Chemical Review Manager (CRM): Heather Garvie,
<EMAIL_ADDRESS>
Antimicrobials Division Product Manager (PM): Marshall Swindell,
HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>for registration #1529-30; and Velma Noble,   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>for registration #
1529-29

Chemical Structure of Alkyl Amine Hydrochloride

Use & Usage Information

Alkyl amine hydrochloride(derived from fatty acids of coconut oil) is an
antimicrobial pesticide used for material preservative use sites such as
resins, paints, adhesives, printing inks and dispersed colors, caulks,
spackling, joint cements, sealants, grouts, and ready mix wallboard
compounds.  The pesticide acts as a bacteriostat and fungicide.

Alkyl amine hydrochloride is registered as a formulation intermediate on
labels and is a non-food use chemical.

There are two registered products containing alkyl amine hydrochloride
as an active ingredient, formulated as liquid or soluble concentrate.

Pests controlled include deterioration/spoilage bacteria and fungi.

Per the labels, the application rate for registration #15219-29 ranges
from 0.15% to 0.3% by weight in the final formulations but should not
exceed 0.5% of the final product for any application.

The application rate for registration #15219-30 ranges from 0.35% to
0.75% based on total net weight of the product to be treated.

Recent Regulatory Actions

Reregistration Eligibility Decision (RED) document completed in 1992.

In October 2003, registration # 4313-47 was cancelled, eliminating a
household and medical/hospital floor use.

Human Health Risk Assessment Status

The Agency anticipates that additional toxicity and exposure data will
be needed for registration review.  In addition, the EPA anticipates
that an occupational and residential handler assessment will need to be
conducted for the dermal and inhalation exposure routes of exposure,
since no specific quantitative occupational or residential risk
assessments are currently available for alkyl amine hydrochloride.  The
Agency feels that it needs to conduct risk assessments to ensure that
the alkyl amine hydrochloride registration review case meets the
registration and safety standards established by FIFRA, as amended by
FQPA and the Federal Food, Drug and Cosmetic Act (FFDCA). For a detailed
discussion of the anticipated risk assessment and data needs for human
health please refer to Section 6 of the Summary of Human Health Effects
Data for Alkyl Amine Hydrochloride (Coco Alkyl Amine Registration Review
Case) Decision Document, dated October 25, 2007.

Ecological Risk Assessment Status

Ecological risk assessments have not been conducted for alkyl amine
hydrochloride since there is no exterior exposure from its indoor use.
However, the Agency has reviewed four basic ecotoxicology studies for
alkyl amine hydrochloride and, although some of the studies were
deficient in their conduct, they were adequate to provide the Agency
with sufficient information to determine appropriate label precautions.
Based on its review, the Agency believes that no additional data or
assessment of the ecological risks is needed for alkyl amine
hydrochloride.

Based on indoor use patterns, low exposure levels, and low toxicity
potential of alkyl amine hydrochloride, the Agency expects that the
registered uses of alkyl amine hydrochloride will have “no effect”
(NE) on endangered or threatened terrestrial or aquatic species, or
their designated critical habitats as listed by the U.S. Fish and
Wildlife Service (USFWS) and the National Oceanic and Atmospheric
Administration (NOAA). However, EPA will review any comments made by the
public on this document and will conduct another environmental risk
assessment, if new information warrants such action.

Tolerances

There are no tolerances or exemptions from tolerance listed under 40 CFR
180.448 for alkyl amine hydrochloride.

There are no proposed direct food or feed uses of alkyl amine
hydrochloride, therefore, EPA has not established tolerances or
exemptions from tolerances in raw agricultural commodities or processed
food and feed products under FFDCA.

Because there is an adhesive use for alkyl amine hydrochloride and there
are no use limitations stated on either of the labels, there may be
potential for indirect food contact.  During the public comment period
the Agency may receive additional information clarifying use patterns
for alkyl amine hydrochloride.  Therefore, the Agency may conduct a
dietary risk assessment in the future.

Data Call-In Status

A GDCI (generic data call-in) was issued for alkyl amine hydrochloride
in January 1989 and November 1991.

A PDCI (product-specific data call-in) was issued for alkyl amine
hydrochloride in August 1992.

Labels

There are two registered products for the active ingredient alkyl amine
hydrochloride. Due to the small number of products associated with this
active ingredient, the two product labels have been included in the
alkyl amine hydrochloride docket. For future reference, during
registration review, a list of product registration numbers will be
included in the docket. Product registration labels may be obtained from
the Pesticide Product Label System (PPLS) website at:   HYPERLINK
"http://oaspub.epa.gov/pestlabl/ppls.home"
http://oaspub.epa.gov/pestlabl/ppls.home .

Registration

Number	Product

Name	Company

Name

1529-29	Nuosept 635-W Preservative	International Specialty Products

1529-30	Fungitrol 158 Fungicide	International Specialty Products

Incidents

No incidents related to alkyl amine hydrochloride use were found during
a search of the following databases:  the OPP Incident Data System
(IDS); Poison Control Center data; California Department of Pesticide
Regulation data; and National Pesticide Information Center data.

III. GLOSSARY of TERMS & ABBREVIATIONS

ai		Active Ingredient

AR		Anticipated Residue

ASTM		American Society for Testing and Materials

AWPA		American Wood Preserver’s Association

CFR		Code of Federal Regulations

cPAD		Chronic Population Adjusted Dose

CSF		Confidential Statement of Formula

CSFII		USDA Continuing Surveys for Food Intake by Individuals

DCI		Data Call-In

DEEM		Dietary Exposure Evaluation Model

DFR		Dislodgeable Foliar Residue

DNT		Developmental Neurotoxicity

DWLOC		Drinking Water Level of Comparison

EC		Emulsifiable Concentrate Formulation

EDWC		Estimated Drinking Water Concentration

EEC		Estimated Environmental Concentration

EPA			Environmental Protection Agency

EUP		End-Use Product

FDA		Food and Drug Administration

FIFRA		Federal Insecticide, Fungicide, and Rodenticide Act

FFDCA		Federal Food, Drug, and Cosmetic Act

FQPA		Food Quality Protection Act

FOB		Functional Observation Battery

GENEEC		Tier I Surface Water Computer Model

IR		Index Reservoir

LC50	Median Lethal Concentration.  A statistically derived concentration
of a substance that can be expected to cause death in 50% of test
animals.  It is usually expressed as the weight of substance per weight
or volume of water, air or feed, e.g., mg/l, mg/kg or ppm.

LD50	Median Lethal Dose.  A statistically derived single dose that can
be expected to cause death in 50% of the test animals when administered
by the route indicated (oral, dermal, inhalation).  It is expressed as a
weight of substance per unit weight of animal, e.g., mg/kg.

LOC		Level of Concern

LOAEL		Lowest Observed Adverse Effect Level

µg/g		Micrograms Per Gram

µg/L		Micrograms Per Liter

mg/kg/day		Milligram Per Kilogram Per Day

mg/L		Milligrams Per Liter

MOE		Margin of Exposure

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

MUP		Manufacturing-Use Product

NA		Not Applicable

NAWQA		USGS National Ambient Water Quality Assessment

NPDES		National Pollutant Discharge Elimination System

NR		Not Required

NOAEL		No Observed Adverse Effect Level

OPP		EPA Office of Pesticide Programs

OPPTS		EPA Office of Prevention, Pesticides and Toxic Substances

PAD		Population Adjusted Dose

PAIRA		Pure Active Ingredient Radiolabelled

PCA		Percent Crop Area

PDP		USDA Pesticide Data Program

PHED		Pesticide Handler's Exposure Data

PHI		Preharvest Interval

ppb		Parts Per Billion

PPE		Personal Protective Equipment

ppm		Parts Per Million

PRZM/EXAMS		Tier II Surface Water Computer Model

Q1*	The Carcinogenic Potential of a Compound, Quantified by the EPA's
Cancer Risk Model

RAC		Raw Agriculture Commodity

RED		Reregistration Eligibility Decision

REI		Restricted Entry Interval

RfD		Reference Dose

RQ		Risk Quotient

SCI-GROW		Tier I Ground Water Computer Model

SAP		Science Advisory Panel

SF		Safety Factor

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

TGAI		Technical Grade Active Ingredient

TEP		Typical End-Use Product

USDA		United States Department of Agriculture

UF		Uncertainty Factor

WPS		Worker Protection StandardIV.   SEQ CHAPTER \h \r 1 APPENDIX A

Use Site	Formulation	Method of Application	Application Rate/ Number of
Applications	Use Limitations

Materials preservatives

Resins

	Ready-to-use

1529-29	In-can preservative	0.15 – 0.3% by weight of product; should
not exceed 0.5% of final product	None stated

Paints	Ready-to-use

1529-29	In-can preservative	0.15 – 0.3% by weight of product; should
not exceed 0.5% of final product	None stated

Adhesives	Ready-to-use

1529-29

	In-can preservative	0.15 – 0.3% by weight of product; should not
exceed 0.5% of final product	None stated

	Ready-to-use

1529-30	In-can preservative	0.35 - 0.75% by weight of product	None
stated

Printing inks and dispersed colors	Ready-to-use

1529-29	In-can preservative	0.15 – 0.3% by weight of product; should
not exceed 0.5% of final product	None stated

Caulks, spackling, ready mix joint cements, sealants, grouts,
ready-mixed wallboard compounds	Ready-to-use

1529-30	In-can preservative	0.35 – 0.75% by weight of product	None
stated

Docket Number:  EPA-HQ-OPP-2007-1039

www.regulations.gov

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Docket Number:  EPA-HQ-OPP-2007-1039

www.regulations.gov

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