Document ID: EPA-HQ-OPP-2009-0125-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-12-15T05:00Z

BIOPESTICIDE REGISTRATION ACTION DOCUMENT 

Draft for Public ParticipationProcess

 

2-Methyl-1-butanol 

PC Code: 431602

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

Last updated- November 19, 2009



TABLE OF CONTENTS

 TOC \f I.     EXECUTIVE SUMMARY						           

II.    ACTIVE INGREDIENT OVERVIEW

III.   REGULATORY BACKGROUND

IV.  RISK ASSESSMENT

A. PRODUCT ANALYSIS ASSESSMENT

1.  Product Chemistry and Composition

2.  Analysis and Certification of Limits

3.  Physical and Chemical Characteristics

B.  HUMAN HEALTH ASSESSMENT

			1.  Toxicological Hazard Assessment

			2.  Dose Response  

3.  Dietary Exposure and Risk Characterization

			4.  Drinking Water Exposure and Risk Characterization

			5.	  Acute and Chronic Dietary Exposure and Risks for Sensitive

				  Subpopulations, Particularly Infants and Children

			6.  Occupational, Residential, School, and Daycare Exposure and Risk
Characterization

			7.  Aggregate Exposure from Multiple Routes Including Dermal, Oral,
and Inhalation	

			8.  Cumulative Effects

			9.  Risk Characterization

		C.  ENVIRONMENTAL ASSESSMENT

			1.  Summary of Non-Target Organism Testing and Waiver Rationales

			2.  Environmental Effects Conclusions

  			3.  Threatened and Endangered Species Assessment

V.     ENVIRONMENTAL JUSTICE

VI.    RISK MANAGEMENT AND REGISTRATION DECISIONS

A. DETERMINATION OF ELIGIBILITY

B. REGULATORY DECISION

C. LABELING

VII.   ACTIONS REQUIRED BY THE REGISTRANT

A. REPORTING OF ADVERSE EFFECTS AND HYPERSENSITIVITY INCIDENTS

VIII.  GLOSSARY OF ACRONYMS AND ABBREVIATIONS

IX.    BIBLIOGRAPHY STUDIES SUBMITTED IN SUPPORT OF THIS REGISTRATION

		A. STUDIES SUBMITTED IN SUPPORT OF THIS REGISTRATION

		B. EPA RISK ASSESSMENT MEMORANDA

APPENDIX-BIOCHEMICAL PESTICIDE DATA REQUIREMENTS

 

BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

Biochemical Pesticides Branch (BPB)

					Chris Pfeifer							Regulatory Action Leader

					Linda Hollis							Branch Chief

					Russell Jones, Ph.D					Senior Biologist

					Jacob Moore							Product Analysis, Human Health

Clara Fuentes, Ph.D.					Product Performance

I.    EXECUTIVE SUMMARY tc "I.    EXECUTIVE SUMMARY/FACT SHEET" 

The biochemical active ingredient, 2-Methyl-1-butanol, is a colorless
alcohol, which occurs naturally in fruit, wine and beer, and has an odor
reminiscent of whiskey.  It is commonly used as a flavor agent intended
for human consumption.  As a biopesticide, it is intended for use in
traps to attract wasps, hornets and yellowjackets.  EPA has determined
that 2-Methyl-1-butanol presents no issues of toxicological, ecological,
or environmental concern.  Accordingly, EPA is considering approval for
a registration for 2-Methyl-1-butanol under Section 3(c)(5) of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).    

	 

Adequate mammalian toxicology data and other information were submitted
to support the registration of 2-Methyl-1-butanol.  Acute toxicity data
from the Hazardous Substances Data Bank provided sufficient information
to satisfy acute oral toxicity, acute dermal toxicity, primary eye
irritation and primary dermal data requirements.  The Agency received
acceptable rationales to support data waivers for acute inhalation
toxicity and dermal sensitization.

Nontarget organism and environmental fate data requirements were waived
based on rationales and information on file with the Agency.  Notably,
2-Methyl-1-butanol is known to occur naturally in the terrestrial
environment without known detrimental effects; and all information
available to the Agency validates a non-toxic mode of action.  I
addition, the public literature confirms a lack of risk in the case of
secondary aquatic exposures.    

The toxicological data demonstrate that 2-Methyl-1-butanol is not toxic
or pathogenic to mammals. No acute, sub-chronic, chronic, immune,
endocrine, or non-dietary exposure issues indicate that the use of the
active ingredient could be expected to cause no harm to infants,
children, and the general U.S. population.  Because of the low toxicity
profile and the directed (and contained) use of the active ingredient,
the risks associated with the proposed uses of this active ingredient
are expected to be negligible.  

Dietary exposures (including exposures via drinking water) are not
expected for the active ingredient 2-Methyl-1-butanol.  The active
ingredient is intended only for non-food uses.  Even in the event of
incidental dietary exposures, the dietary risks would be negligible
given the limited potential for any significant exposure associated with
the use of this attractant.  The risks associated with any incidental
dietary exposures would be negligible considering the low acute toxicity
profile of the active ingredient and the history of human ingestion of
2-Methyl-1-butanol without any known adverse effects.   

The potential for aggregate, non-occupational exposure is expected to be
insignificant as 2-Methyl-1-butanol is not expected to be present in
quantities greater than 2.466 x 109 g/liter air/week, and limited only
to those times when yellowjackets and wasps are active.  Moreover, given
a lack of acute toxicological endpoints and that 2-Methyl-1-butanol is
not known to share any structural similarity to any chemicals with a
common mechanism of toxicity, the likelihood of risks resulting from
such de minimus exposures is negligible.

Data waiver rationales were submitted in response to data requirements
for avian, freshwater fish and invertebrate, insect, and honeybee
non-target organism testing requirements. The information provided is
sufficient to satisfy the Tier I non-target organism data requirements
for the proposed end-use products containing 2-Methyl-1-butanol as an
active ingredient, and further testing of non-target organisms at higher
tier levels is not required.  Based on the rationales submitted, adverse
effects to terrestrial animals and plants or freshwater and
marine/estuarine fish, invertebrates, and plants are not expected as a
result of exposure to the attractant 2-Methyl-1-butanol.  Furthermore,
BPPD made “No Effect” (NE) determinations for direct and indirect
effects to listed threatened and endangered species and their habitat as
a result of the proposed uses of 2-Methyl-1-butanol.

On October 1, 2009, EPA announced a new policy to provide a more
meaningful opportunity for the public to participate on major
registration decisions before they occur.  According to this new policy,
EPA intends to provide a public comment period prior to making a
registration decision for, at minimum, the following types of
applications: new active ingredients, first food use, first outdoor use,
and first residential use.  

Consistent with the new policy of making registration actions more
transparent, 2-Methyl-1-butanol is subject to a 30 day comment period as
a “new active ingredient” whose registration would result in a
“first outdoor use” and a “first residential use.”  While a
final decision on registration is contingent upon review and
consideration of public comments, EPA presently believes, based on the
risk assessment and information submitted in support of the registration
of  2-Methyl-1-butanol, that it is in the best interests of the public
and the environment to issue the registration for 2-Methyl-1-butanol. 
The basis for this preliminary decision can be found in the risk
assessment for 2-Methyl-1-butanol, which is characterized in this BRAD. 
As discussed above, acute toxicity data for 2-Methyl-1-butanol
demonstrate that it is toxicity category IV.  2-Methyl-1-butanol does
not demonstrate subchronic or developmental toxicity, and it is not
mutagenic or genotoxic.  EPA has no concerns for any non-target
organisms exposed to 2-Methyl-1-butanol in accordance with approved
label directions.  EPA has not identified any toxic endpoints for
non-target mammals, birds, plants, aquatic, or soil organisms. Nor or
there concerns for any threatened and endangered species.  Thus, given
that 2-Methyl-1-butanol has very low toxicity and presents little if any
risk to non-target organisms, and efficacy data confirm its
effectiveness against target pests, EPA preliminarily concludes that it
is in the best interests of the public and the environment to issue the
registration for 2-Methyl-1-butanol.  

EPA reviewed data requirements for granting registration under Section
3(c)(5) of the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA).  It was determined that the data/information submitted
fulfilled current guideline requirements (refer to 40 CFR Subpart U §
158.2000).  If the Agency receives comments during the 30 day public
comment period that inform EPA’s initial decision, EPA will address
such new information and take appropriate action.    

II.		ACTIVE INGREDIENT OVERVIEW

Common Name: 			2-Methyl-1-butanol

Chemical Names: 		2-Methyl-1-butanol

Trade & Other Names:	Active Amyl Alcohol

CAS Registry Number: 	137-32-6

OPP Chemical Code: 	431602

Type of Pesticide: 		Attractant 

 		III.  REGULATORY BACKGROUND

EPA published in the Federal Register (FR) on March 16, 2009 (Volume 74,
Number 49) a notice announcing that Bull Run Scientific, VBT, Beaufont
Springs Drive, Suite 300, Richmond, VA 23225, submitted an application
to register a pesticide product (EPA File Symbol 84565-T) containing a
new active ingredient (2-Methyl-1-butanol) not included in any currently
registered products. No comments were received following the publication
of this notice. 

CLASSIFICATION 

2-Methyl-1-butanol is well recognized as a naturally occurring alcohol. 
With regard to its active properties, it is considered to be an
attractant, and is not associated with direct toxicity to its target
pests.  Notably, pests are not harmed by the attractant; rather they are
killed by physical means in the trap.  Accordingly, 2-Methyl-1-butanol
is considered to be a biochemical pesticide due to its nontoxic mode of
action to target pest, natural occurrence in the environment, and its
history of exposure to humans and the environment demonstrating minimal
toxicity. 

FOOD CLEARANCES/TOLERANCES 

Currently, this active ingredient is not registered for use on food or
feed commodities, and the applicant has not filed a petition for a
tolerance (nor a tolerance exemption) for 2-Methyl-1-butanol. As a
result, a tolerance or exemption from the requirement of a tolerance is
not relevant. 

IV.  RISK ASSESSMENT

 tc "III.  SCIENCE ASSESSMENT"  

On October 26, 2007, the Agency issued a Final Rule in the Federal
Register on the data requirements to support registration of biochemical
and microbial pesticides, and updated the definitions for biochemical
and microbial pesticides (  HYPERLINK
"http://www.epa.gov/fedrgstr/EPA-TOX/2007/October/Day-26/t20828.htm"  72
FR 61002 ). The rule became effective on December 26, 2007. The data and
information evaluated for this Biopesticides Registration Action
Document (BRAD) were considered in light of these requirements.

The classifications that are found for each data submission are assigned
by EPA science reviewers and are an indication of the usefulness of the
information contained in the documents for risk assessment. A rating of
“ACCEPTABLE” indicates the study is scientifically sound and is
useful for risk assessment. A “SUPPLEMENTAL” rating indicates the
data provide some information that can be useful for risk assessment.
The studies may have certain aspects determined not to be scientifically
acceptable (“SUPPLEMENTAL: UPGRADABLE”). If a study is rated as
“SUPPLEMENTAL: UPGRADABLE,” the Environmental Protection Agency
always provides an indication of what is lacking or what can be provided
to change the rating to “ACCEPTABLE.” If there is simply a
“SUPPLEMENTAL” rating, the reviewer will often state that the study
is not required by the current 40 CFR Part 158. Both “ACCEPTABLE”
and “SUPPLEMENTAL” studies may be used in the risk assessment
process as appropriate. An “UNACCEPTABLE” rating indicates that new
data need to be submitted.

For the acute toxicity data requirements, toxicity categories are
assigned for providing the appropriate precautionary labeling statement,
based on the hazard(s) identified from studies and/or other information
submitted to the Agency in support of a pesticide registration.  The
active ingredient or particular product is classified into Toxicity
Category I, II, III, or IV, where Toxicity Category I indicates the
highest toxicity and Toxicity Category IV indicates the lowest toxicity.
 

	A.  PRODUCT ANALYSIS ASESSMENT  tc "A.   Physical and Chemical
Properties Assessment " \l 2 

	

1.  Product Chemistry and Composition 

2-Methyl-1-butanol is a naturally occurring alcohol that can be found in
fruits, beer and wine.  It has an odor that is described variously as
whiskey-like, wine-like or onion-like. 2-Methyl-1-butanol is commonly
used to formulate both artificial fragrances and flavors.  It is the
inherent redolence of the active ingredient that produces its
effectiveness as a pesticidal attractant.  

All product chemistry data requirements for 2-Methyl-1-butanol have been
satisfied. As an active ingredient, 2-Methyl-1-butanol is produced
industrially with synthetic starting materials, but purified through
later manufacturing processes.  The nominal purity of the active
ingredient is very high, and there are no impurities of toxicological
significance.  All data requirements for physical and chemical
characteristics have been adequately addressed.     

2.  Analysis and Certification of Limits

The submitted data satisfied the requirement for Analysis and
Certification of Limits.  Five batch analyses and the analytical method
used to determine the purity of 2-Methyl-1-butanol were examined and
determined to be acceptable by the Agency.  The certified limits for the
active and inert ingredients fall within the ranges specified by OPPTS
Guideline 830-1750.   

3.  Physical and Chemical Characteristics

The Agency has determined that the submitted data adequately describe
the physical and chemical characteristics of 2-Methyl-1-butanol.  Refer
to Table 1 in Appendix A for The Series 830 physical and chemical
properties.   

	B.   HUMAN HEALTH ASSESSMENT 

	1.  Toxicological Hazard Assessment 

Adequate mammalian toxicology data/information was provided in support
of the registration of 2-Methyl-1-butanol. Acute toxicology information
for 2-Methyl-1-butanol, submitted in lieu of guideline studies,
indicates that the active ingredient is virtually non-toxic to mammals,
and that there are no toxicological endpoints relative to the use of
2-Methyl-1-butanol as an attractant.  Public literature from Chemical
Carcinogenesis Research Information System (CCRIS) indicates that
2-Methyl-1-butanol is non-mutagenic.  Altogether, the information
submitted demonstrates that the proposed uses of 2-Methyl-1-butanol pose
no significant risks to human health.    

Refer to Table 2 in Appendix A for a summary of the Toxicity Data
Requirements for this non-food use active ingredient.

			a. Acute Toxicity – Tier I (40 CFR § 158.2050) 

Acute Oral Toxicity – Rat [OPPTS Guideline 870.1100; Master Record
Identification (MRID) Number (No.) 472465-07]:  Information from the
Hazardous Substances Data Bank (HSDB), submitted in lieu of a guideline
study, shows that the active ingredient 2-Methyl-1-butanol has an LD50
of 4.92 mL/kg in rats, which is considered to be virtually non-toxic. 
However, additional information was submitted demonstrating that there
are no significant oral exposures to the active ingredient when it is
used as an attractant, obviating any oral toxicity risks.   This
information was found “ACCEPTABLE” and 2-Methyl-1-butanol was
classified as TOXICITY CATEGORY IV for this route of exposure when used
as an attractant.

Acute Dermal Toxicity– Rabbits (OPPTS Guideline 870.1200; MRID No.
472465-07): Information from the HSDB, submitted in lieu of a guideline
study, shows that the active ingredient 2-Methyl-1-butanol has an LD50
of 2.58 g/kg in rabbits.  Additional information was submitted
demonstrating that there are no significant dermal exposures to the
active ingredient when it is used as an attractant, obviating any acute
dermal toxicity risks.   This information was found “ACCEPTABLE” and
2-Methyl-1-butanol was classified as TOXICITY CATEGORY IV for this route
of exposure when used as an attractant.

  

Acute Inhalation Toxicity (OPPTS Guideline 870.1300; MRID No.
472465-07):  A waiver was granted based on the rationale that there is
effectively no inhalation exposure.  Calculations were provided
demonstrating that the maximum amount of active ingredient present in
the air is less than 2.466 x 109 g/liter air/week – an infinitesimal
amount, especially when compared to the amounts of 2-Methyl-1-butanol
inhaled as a result of our regular exposures to fruits and fragrances. 
A waiver was granted and 2-Methyl-1-butanol was classified as TOXICITY
CATEGORY IV for this route of exposure when used as an attractant.     

Primary Eye Irritation (OPPTS Guideline 870.2400; MRID No. 472465-07): 
A waiver was granted based on the rationale that there is effectively no
ocular exposure.  The active ingredient is contained in a trap, and as
referenced above when it is volatilized the amount of active ingredient
present is so negligible that it may be considered comparable to
naturally occurring exposure, which are not known to pose risks. This
waiver was granted and 2-Methyl-1-butanol was classified as TOXICITY
CATEGORY IV based on a lack of exposure when used as an attractant.

Primary Dermal Irritation (OPPTS Guideline 870.2500; MRID No.
472465-07): Information from the HSDB submitted in lieu of a guideline
study, shows that the active ingredient 2-Methyl-1-butanol is only
minimally irritating to skin.  Coupled with the established lack of
significant dermal exposure, this information was found “ACCEPTABLE”
and 2-Methyl-1-butanol was classified as TOXICITY CATEGORY IV for this
route of exposure when used as an attractant.

Skin Sensitization (OPPTS Guideline 870.2600; MRID No. 472465-07):  A
waiver was granted based on the lack of dermal exposure and the low
dermal toxicity profile established in the HSDB literature.  While the
waiver was granted, any reported incidents may cause this position to be
reconsidered. 

Subchronic Testing (OPPTS Guidelines 870.3100, 870.3250, 870.3465; MRID
No. 472465-07):  Subchronic testing data requirements do not apply in
this case.  Footnotes six, seven and eight for the respective subchronic
testing requirements found in the Biochemical Pesticides Human Health
Assessment Data Requirements table in 40 CFR § 158.2050 are relevant. 
90-day oral testing is not required because there are no repeat oral
exposures.  90-day dermal testing is not required because there would be
neither a purposeful application to the skin nor prolonged dermal
exposure to the active ingredient.  The 90-day inhalation testing is,
likewise, not required for there is no repeated exposure by inhalation.

Developmental Toxicity (OPPTS Guideline 870.3700; MRID No. 472465-07): 
In accordance with footnote nine in the Biochemical Pesticides Human
Health Assessment Data Requirements table in 40 CFR § 158.2050, the
developmental toxicity data requirement are not required because there
is no significant exposure to female humans.

Mutagenicity Testing (OPPTS Guidelines 870.5100, 870.5300, 870.5375;
MRID No. 472465-07):  In accordance with footnote ten in the Biochemical
Pesticides Human Health Assessment Data Requirements table in 40 CFR §
158.2050, the data are not required due to lack of exposure and the
absence of any structural similarity to a known mutagen.  The
registrant, however, submitted information from the public literature
(CCRIS) for an In vitro Mammalian Cell Assay.  Therein, a 4.6 mM dose
substantiated 2-Methyl-1-butanol as negative for mutagenicity.

b.	Acute Toxicology and Subchronic Toxicity/Pathogenicity – Tier II;
Reproductive Fertility Effects, Carcinogenicity, Immunotoxicity, and
Infectivity/Pathogenicity Analysis – Tier III (40 CFR § 158.2050)

Tier II and Tier III studies were not required for 2-Methyl-1-butanol
based on the lack of exposure and the lack of acute toxicity indicated
in the Tier I information. 

			c.   Effects on the Endocrine System

EPA will issue test orders between today and February 2010.  The
schedule for issuance of test orders, and details regarding status will
be available at http://www.epa.gov/endo/.  EPA has also established a
docket for the test orders in www.regulations.gov under docket number
EPA-HQ-OPP-2009-0634. 

Data required under the test orders will provide information to help EPA
identify whether chemicals have the potential to interact with the
estrogen, androgen, and/or thyroid hormone systems, which regulate
growth, metabolism, development, and reproduction.  The data generated
from the screens will provide robust and systematic scientific
information that will help EPA identify whether additional testing is
necessary.

2-Methyl-1-butanol is a naturally occurring alcohol in fruits, beer and
wine.  To date, there is no evidence to suggest that our natural
exposure to 2-Methyl-1-butanol affects the immune system, functions in a
manner similar to any known hormone, or that it acts as an endocrine
disruptor.  Moreover, the use of 2-Methyl-1-butanol is not expected to
result in any significant exposures, effectively obviating any
opportunity for negative effects on humans or the environment. 
Therefore, it is unlikely that 2-Methyl-1-butanol will have estrogenic
or endocrine effects.

		2.   Dose Response Assessment 

No toxicological endpoints were identified; therefore, a dose response
assessment was not required.  

		3.   Dietary Exposure and Risk Characterization

The active ingredient 2-Methyl-1-butanol is intended for non-food uses. 
Accordingly, it is not expected to pose any direct dietary risk to
humans.  With regard to any incidental exposure, all routes of exposure
associated with the active ingredient’s use as an attractant are
negligible.  Additionally, the active ingredient occurs naturally in
fruit and is a well-recognized flavor agent in food additives.  Its
regular consumption in a human diet is not associated with any hazards. 
Finally, the acute toxicity information on file indicates that the risks
associated with even incidental exposures would be negligible. 

	4.   Drinking Water Exposure Risk Characterization 

Incidental dietary exposure via drinking water is expected to be
unlikely.  The product volatilizes into the air and its exposure
potential is localized.  Additionally, the active ingredient volatilizes
in measured doses and its proposed concentrations are so small that any
potential exposures are expected to resemble those that occur naturally.
  Accordingly, 2-Methyl-1-butanol is not expected to pose any dietary
risk when used as an attractant.  Further, even if humans were exposed
to 2-Methyl-1-butanol in drinking water, the information regarding acute
oral toxicity suggests no adverse effect via drinking water. 

5.   Acute and Chronic Dietary Exposure and Risks for Sensitive
Subpopulations, Particularly Infants and Children 

Based on the non-food use pattern, the limited potential for even
incidental exposure, and the dietary toxicity information discussed
above, EPA concludes that there is a reasonable certainty that no harm
will result to the United States population, including infants and
children, from aggregate exposure to any incidental residues of
2-Methyl-1-butanol.    

6.   Occupational, Residential, School and Day Care Exposure and Risk
Characterization

Given the miniscule exposure potential associated with
2-Methyl-1-butanol and the low toxicity profile indicated in the acute
toxicology information, no risks are expected for any of these exposure
scenarios.   

	

			a. Occupational Exposure and Risk Characterization

This pesticide is intended for residential use patterns.  Nonetheless,
there would be no risks associated with professional handlers. 
Potential occupational exposures to 2-Methyl-1-butanol are not a concern
based on the seasonal nature of pest pressure, the negligible potential
for exposure, the low toxicity profile of the active ingredient, and the
active ingredient’s nontoxic mode of action.  

			b. Residential, School, and Daycare Exposure and Risk
Characterization

The Agency does not expect any risks to children (or adults) in any of
these environments.  Due to the low rate of volatilization of the
attractant, the potential for significant exposure is negligible.  The
active ingredient has a low toxicity profile and a history of
consumption without incident.   The exposure is limited by the
seasonality of the use of traps.  And because 2-Methyl-1-butanol is
contained in traps, it is not readily accessible in any direct exposure
scenario.  Due to limited exposure scenarios and negligible toxicity
hazards, no risks are expected relative to these exposure scenarios.   

7.   Aggregate Exposure from Multiple Routes Including Dermal, Oral, and
Inhalation 

The potential for aggregate exposure is expected to be insignificant. 
2-Methyl-1-butanol is not expected to be present in quantities greater
than 2.466 x 109 g/liter air/week, and limited only to those times when
yellowjackets, hornets and wasps are active.  Given a lack of acute
toxicological endpoints for 2-Methyl-1-butanol, the aggregate exposure
scenario presents no significant concerns for risk.

		8.   Cumulative Effects 

2-Methyl-1-butanol is intended for non-food uses as an attractant in a
trap.  No dietary exposures are expected.  To the degree that there
might be any incidental dietary exposure, 2-Methyl-1-butanol does not
share any known common mechanism of toxicity with other substances.  

		9.  Risk Characterization

The Agency considered human exposure to 2-Methyl-1-butanol in light of
the relevant safety factors in FQPA and FIFRA.  A determination has been
made that no unreasonable adverse effects to the U.S. population in
general, and to infants and children in particular, will result from the
use of 2-Methyl-1-butanol when label instructions are followed. 

	C.  ENVIRONMENTAL ASSESSMENT

1.   Ecological Hazards (Relative to the Biochemical Pesticides
Nontarget Organisms and Environmental Fate Data Requirements - 40 CFR §
158.2060)

Nontarget organism and environmental fate data requirements were waived
due to a lack of exposure and the active ingredient’s non-toxic mode
of action.  2-Methyl-1-butanol occurs naturally in fruit.  No known
adverse effects have been associated with its exposure to insects,
birds, aquatic life or vegetation.  Moreover, the active ingredient is
contained in traps and has no direct or significant contact with birds,
mammals, fish, or surrounding vegetation.  With regard to
2-Methyl-1-butanol’s attractive qualities for yellowjackets, wasps and
hornets, the efficacy trials demonstrate that its attraction is
specifically targeted at these pests.  Honeybees or other beneficial
insects were shown to not be attracted to the traps. And to the tiny
degree that there is any exposure to nontarget organisms, the active
ingredient has no demonstrable toxicity.  In sum, all nontarget
toxicology data requirements for 2-Methyl-1-butanol have been satisfied.

Avian Testing (OPPTS Guidelines 850.2100, 850.2200; MRID Nos. 47457006
and 47457007): 

A waiver was granted based on a lack of exposure.  The active ingredient
is contained in traps and is inaccessible to birds.  Any atmospheric
exposure to birds would be miniscule.  In any event, there are no
incidences of toxicity to birds with regard to avian exposure relative
to 2-Methyl-1-butanol’s natural presence in fruits.

Aquatic Organism Testing (OPPTS Guidelines  850.1075, 850.1010; MRID
Nos. 47457006 and 47457007):   A waiver was granted based on a lack of
exposure.  The active ingredient is contained in traps and is
inaccessible to aquatic organisms.  Any incidental residues that might
drift into water would be negligible.  And even in the event of any
accidental and direct exposure, data were submitted that confirm the
lack of toxicity to fish.  Information presented in MRID 47457001 shows
the 2-methyl-1-butanol LC50 for fish is >100 mg/L, and the 96-hr acute
static LC50 for fathead minnows is 580 mg/L.   

 

Non-Target Plant Testing (OPPTS Guidelines 850.4100, 850.4150; MRID No.
472465-10; MRID Nos. 47457006 and 47457007):  A waiver was granted based
on a lack of exposure.  The active ingredient is contained in traps and
would have no direct contact with plants.  Any incidental residues that
might drift onto plants would be negligible, and virtually indiscernible
from the naturally occurring volatilized 2-Methyl-1-butanol from fruits.

Non-Target Insect Testing (OPPTS Guideline 880.4350); MRID Nos. 47457006
and 47457007, 47457301):  A waiver was granted based on the fact that
nontarget exposure to the active ingredient is negligible and that
information indicates that the volatilized active ingredient is targeted
at yellowjackets, wasps, and hornets, with no demonstrable effects on
nontarget insects.

2.  Environmental Fate and Ground Water Data

The need for environmental fate and groundwater data was not triggered
because results of the acute toxicity assessment did not trigger any
additional Tier I studies.

Ecological Exposure and Risk Characterization

The active ingredient is intended for formulation of end use products
which would be placed in insect traps for residential or agricultural
use. When used according to the proposed label directions, no direct
exposures are expected for nontarget organisms. Moreover, the active
ingredient is used at a low concentration as an attractant, and is not
expected to accumulate in the environment. Given these characteristics
of 2-Methyl-1-butanol, nontarget exposure and ecological effects studies
were waived.

		

4.   Threatened and Endangered Species Assessment

Based on the available data, a No Effects (NE) determination was made
for 2-methyl-1-butanol on threatened and endangered species when the
product is used according to label use directions.  Specifically, in
MRID 47457301, efficacy testing showed no honeybees or other non-target
insect species were attracted or caught by the 2-methyl-1-butanol
product.  Since the active ingredient in contained in a trap, there is
no exposure to birds, fish, aquatic invertebrates, or other non-target
organisms.

V.   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 2-Methyl-1-butanol, 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.

VI.   RISK MANAGEMENT AND REGISTRATION DECISIONS tc "V.   RISK
MANAGEMENT AND REGISTRATION DECISION" 

	A.  Determination of Eligibility 

 tc "A.  Determination of Eligibility " \l 2 

Section 3(c)(5) of FIFRA provides for the registration of new active
ingredients if it is determined that (A) its composition is such as to
warrant the proposed claims for it; (B) its labeling and other materials
required to be submitted comply with the requirements of FIFRA; (C) it
will perform its intended function without unreasonable adverse effects
on the environment; and (D) when used in accordance with widespread and
commonly recognized practice it will not generally cause unreasonable
adverse effects on the environment. 

The four criteria of the Eligibility Determination for Pesticidal Active
Ingredients are satisfied by the science assessments supporting products
containing 2-Methyl-1-butanol.  Such products are not expected to cause
unreasonable adverse effects, and are likely to provide protection as
claimed when used according to label instructions. Therefore, EPA
preliminarily concludes that 2-Methyl-1-butanol is eligible for
registration for the labeled uses.

B.  Regulatory Decision

On October 1, 2009, EPA announced a new policy to provide a more
meaningful opportunity for the public to participate on major
registration decisions before they occur.  According to this new policy,
EPA intends to provide a public comment period prior to making a
registration decision for, at minimum, the following types of
applications:  new active ingredients; first food use; first outdoor
use; and first residential use.  Accordingly, this pesticide is subject
to a 30-day comment period as a new active ingredient with both outdoor
uses and residential uses.  Any regulatory decision will be informed by
the comments EPA receives.

At this time, EPA believes, the data submitted fulfill the requirements
of registration for products containing 2-Methyl-1-butanol for use to
attract yellowjackets, wasps and hornets. Acute toxicity data for
2-Methyl-1-butanol demonstrate that it is toxicity category IV for all
routes of exposure.  2-Methyl-1-butanol does not demonstrate subchronic
or developmental toxicity, and it is not mutagenic or genotoxic.  EPA
has no concerns for any non-target organisms exposed to
2-Methyl-1-butanol in accordance with approved label directions.  EPA
has not identified any toxic endpoints for non-target mammals, birds,
plants, aquatic, or soil organisms. Nor are there concerns for any
threatened and endangered species.  Given, the non-toxic character of
2-Methyl-1-butanol, EPA supports its registration under Section 3(c)(5)
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 
Refer to Appendix B for product-specific information.

		1.  Conditional/Unconditional Registration

All data requirements are fulfilled and EPA has preliminarily determined
that an unconditional registration for Methyl-1-butanol is warranted
under Section 3(c)(5) of FIFRA. 

		C.  Labeling

Before releasing pesticide products containing Methyl-1-butanol for
shipment, the applicant is required to provide appropriate labels.

VII.   ACTIONS REQUIRED BY THE REGISTRANT

The Agency evaluated the data submitted in connection with the initial
registration of  Methyl-1-butanol and determined that these data fulfill
current registration guideline requirements.  No additional data are
required to be submitted to the Agency at this time.  Additional data
may be required for new uses and/or changes to existing uses.  

Not withstanding the information stated in the previous paragraph, it
should be clearly understood that certain, specific, data are required
to be reported to the Agency as a requirement for maintaining the
Federal registration for a pesticide product. A brief summary of these
types of data are listed below.   

	A.  Reporting of Adverse Effects and Hypersensitivity Incidents

Reports of all incidents of adverse effects to the environment must be
submitted to the Agency under the provisions stated in FIFRA, Section
6(a)(2).

Additionally, all incidents of hypersensitivity (including both
suspected and confirmed incidents) must be reported to the Agency under
the provisions of 40 CFR Part 158.2140 OPPTS Guideline reference number
885.3400.

VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS

BPPD	Biopesticides and Pollution Prevention Division

BRAD	Biopesticide Registration Action Document

CFR	Code of Federal Regulations

cm3 	cubic centimeter

CSF	Confidential Statement of Formula

°C 	degrees Celsius

EDSP	Endocrine Disruptor Screening Program

EDSTAC	Endocrine Disruptor Screening and Testing Advisory Committee

EPA	Environmental Protection Agency (the “Agency”)

FFDCA	Federal Food, Drug, and Cosmetic Act

FIFRA	Federal Insecticide, Fungicide, and Rodenticide Act

FQPA 	Food Quality Protection Act

FR	Federal Register

g 	gram

kg	kilogram

L                  liter

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, or inhalation). It is expressed as a weight of

	substance per unit weight of animal (e.g., mg/kg).

MRID No.	Master Record Identification Number

mg	milligram

mL	milliliter

MP	manufacturing-use product

MPCA	microbial pest control agent

NE	“No Effect”

NIOSH 	National Institute for Occupational Safety and Health

OPP	Office of Pesticide Programs

OPPTS 	Office of Prevention, Pesticides, and Toxic Substances

PCR	polymerase chain reaction 

PPE 	personal protective equipment

TGAI 	technical grade of the active ingredient

IX. BIBLIOGRAPHY STUDIES SUBMITTED IN SUPPORT OF THIS REGISTRATION

Studies Submitted in Support of this Registration.

MRID	Citation	Receipt Date

47451400	Bull Run Scientific, VBT (2008) Submission of Product
Chemistry, Environmental Fate, and Toxicity Data in Support of the
Application for Registration of Disposable Bull Run Yellowjacket Trap E.
Transmittal of 5 Studies.	17-Jun-2008

47451401	Smith, C. (2008) (Inert Ingredient): Product Identity,
Composition and Analysis. Unpublished study prepared by Bull Run
Scientific, VBT. 19 p.	17-Jun-2008

47451402	Smith, C. (2008) (Inert Ingredient): Color, Physical State,
Odor, Stability, UV/Visible Light Absorption, Melting Point, Density,
Dissociation Constant, Partition Coefficient, Water Solubility, and
Vapor Pressure. Unpublished study prepared by Bull Run Scientific, VBT.
14 p.	17-Jun-2008

47451403	Smith, C. (2008) (Inert Ingredient): pH. Unpublished study
prepared by Bull Run, LLC. 13 p.	17-Jun-2008

47451404	Smith, C. (2008) (Inert Ingredient) (TGAI) and Disposable Bull
Run Yellowjacket Trap E: Environmental Fate and Effects on Nontarget
Organisms. Unpublished study prepared by Bull Run Scientific, VBT. 7 p.
17-Jun-2008

47451405	Smith, C. (2008) (Inert Ingredient) (TGAI): Mammalian
Toxicology. Unpublished study prepared by Bull Run Scientific, VBT. 7 p.
17-Jun-2008

47451700	Bull Run Scientific, VBT. (2008) Submission of Efficacy Data in
Support of the Applications for Registration of Wasp Hornet Yellowjacket
Attractant System, Yellowjacket Attractant, Disposable Bull Run
Yellowjacket Trap E, Disposable Bull Run Yellowjacket Trap W, and Bull
Run Yellowjacket Attractant Cartridge. Transmittal of 1 Study.
17-Jun-2008

47451701	Smith, C. (2008) Yellowjacket Attractants: Efficacy Data
Overview. Unpublished study prepared by Bull Run Scientific, VBT. 11 p.
17-Jun-2008

47452000	Bull Run Scientific, VBT (2008) Submission of Product Chemistry
and Toxicity Data in Support of the Application for Registration of
Disposable Bull Run Yellowjacket Trap E. Transmittal of 4 Studies.
17-Jun-2008

47452001	Smith, C. (2008) Disposable Bull Run Yellowjacket Trap E:
Product Identity, Composition and Analysis. Unpublished study prepared
by Bull Run Scientific, VBT. 44 p.	17-Jun-2008

47452002	Smith, C. (2008) Disposable Bull Run Yellowjacket Trap E:
Physical State, pH, and Bulk Density. Unpublished study prepared by Bull
Run Scientific, VBT. 17 p.	17-Jun-2008

47452003	Smith, C. (2008) Disposable Bull Run Yellowjacket Trap E:
Corrosion Characteristic and Field Evaluation of Storage Stability and
Impacts on Non-Target Organisms. Unpublished study prepared by Bull Run
Scientific, VBT. 10 p.	17-Jun-2008

47452004	Smith, C. (2008) Disposable Bull Run Yellowjacket Trap E:
Mammalian Toxicology. Unpublished study prepared by Bull Run Scientific,
VBT. 8 p.	17-Jun-2008

47457000	Bull Run Scientific, VBT (2008) Submission of Product Chemistry
and Toxicity Data in Support of the Application for Registration of Wasp
Hornet Yellowjacket Attractant System. Transmittal of 7 Studies.
17-Jun-2008

47457001	Smith, C. (2008) 2-Methyl-1-Butanol: Product Identity and
Composition. Unpublished study prepared by Bull Run Scientific, VBT. 44
p.	17-Jun-2008

47457002	Smith, C. (2008) 2-Methyl-1-Butanol Technical: Preliminary
Analysis, Certified Limits, and Enforcement Analytical Method.
Unpublished study prepared by Bull Run Scientific, VBT. 38 p.
17-Jun-2008

47457003	Smith, C. (2008) 2-Methyl-1-Butanol Technical: Color, Physical
State, Odor, Stability, Flammability, UV/Visible Light Absorption,
Boiling Point, Density, Partition Coefficient, Water Solubility, and
Vapor Pressure. Unpublished study prepared by Bull Run Scientific, VBT.
28 p.	17-Jun-2008

47457004	Smith, C. (2008) 2-Methyl-1-Butanol: pH. Unpublished study
prepared by Bull Run Scientific, VBT. 13 p.	17-Jun-2008

47457005	Smith, C. (2008) 2-Methyl-1-Butanol: Dissociation Constant anf
Particle Size. Unpublished study prepared by Bull Run Scientific, VBT. 8
p.	17-Jun-2008

47457006	Smith, C. (2008) 2-Methyl-1-Butanol (TGAI and Formulations):
Effects on Nontarget Organisms. Unpublished study prepared by Bull Run
Scientific, VBT. 8 p.	17-Jun-2008

47457007	Smith, C. (2008) 2-Methyl-1-1Butanol: Acute Toxicity, Prenatal
Developmental Toxicity, and Mutagenicity. Unpublished study prepared by
Bull Run Scientific, VBT. 17 p.	17-Jun-2008

	

B. EPA Risk Assessment Memoranda

Fuentes, C. Science Review in Support of Product Performance Data for
2-Methyl-1-butanol.  Memorandum dated July 22, 2009.

Moore, J.  Science Review in Support of the Registration of
2-methyl-1-butanol. Memorandum dated April 16, 2009. 

Moore, J.  Amended:  Science Review in Support of Disposable Bull Run
Yellowjacket Trap E.  Memorandum dated August 14, 2009.

REFERENCES

1.  Hazardous Substances Data Bank (HSDB).  2002.    HYPERLINK
"http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB" 
http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB .

2.  Chemical Carcinogens Research Information System (CCRIS).  2002. 
http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?CCRIS

APPENDIX A – BIOCHEMICAL PESTICIDE DATA REQUIREMENTS

TABLE 1. Physical/Chemical Properties for 2-methyl-1-butanol

Guideline Reference No./Property	

Description of Result

830.6302	Color	Colorless

830.6303	Physical State	Liquid

830.6304	Odor	Wine, onion (at 100%)

830.6313	Stability	Thermally stable at typical use temperatures.
Exposure to elevated temperatures can cause decomposition.

830.6314	Oxidation/Reduction: 

Chemical Incompatibility	Avoid contact with strong acids and oxidizers.

830.6315	Flammability	Flash point = 50°C (open cup)

Flash point = 43° (closed cup)

830.6316	Explodability	Not required for TGAI

830.6317	Storage Stability	Not required for TGAI

830.6319	Miscibility	Not required for TGAI

830.6320	Corrosion Characteristics	Not required for TGAI

830.6321	Dielectric Breakdown Voltage	Not required for TGAI

830.7000	pH	5.8 ± 0.3 at 21°Cb

(1.0% w/v aqueous solution)

830.7100	Viscosity	Not required for TGAI

830.7200	Melting Range	Not applicable, ingredient is a liquid

830.7220	Boiling Range	128.7°C at 760 mm Hg

830.7300	Density/Relative Density/Bulk Density	0.815 g/cm3

830.7370	Dissociation Constant in Water	Based on its structure,
2-methyl-1-butanol does not contain any readily ionizable protons, and
no significant dissociation of protons in water is expected.

830.7550	Partition Coefficient	Log Kow = 1.29 

830.7840	Water Solubility	3.22 x 104 mg/L at 25°C

830.7950	Vapor Pressure	3 mm Hg at 20°C

4.54 mm Hg at 25°C

TABLE 2.  Toxicity Data Requirements Summary	         

Study Type/OPPTS Guideline	

LD50/LC50/Results	

Reference	MRID

Acute Oral Toxicity/OPPTS 870.1100	4.92 mL/kg in rats	

HSDB	47457007

Acute Dermal Toxicity/OPPTS 870.1200	

2.58 g/kg in rabbits	

HSDB	47457007

Acute Inhalation Toxicity/OPPTS 870.1300	

Waiver Requested	

	47457007

Acute Eye Irritation/OPPTS 870.2400	

Severely Irritating	HSDB	47457007

Acute Dermal Irritation/OPPTS 870.2500	Minimally Irritating	

HSDB	47457007

Skin Sensitization/OPPTS 870.2600	

Waiver Requested	

	47457007

Prenatal Developmental Toxicity/OPPTS 870.3700	

Waiver Requested	

	47457007

Bacterial Reverse Mutation Test/OPPTS 870.5100	

Waiver Requested	

	47457007

In vitro Mammalian Cell Assay	4.6 mM dose was negative in Chinese
hamster V-79 Assay	

CCRIS2

	

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