BIOPESTICIDE REGISTRATION ACTION DOCUMENT

2-Methyl-1-butanol

PC Code: 431602

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

Last updated- January 19, 2010

TABLE OF CONTENTS

 TOC \f I.     EXECUTIVE
SUMMARY………………………………………………………
………..	p.4

II.    ACTIVE INGREDIENT
OVERVIEW……………………………………………………p.5

III.   REGULATORY
BACKGROUND……………………………………………………
…..p.6

IV. RISK
ASSESSMENT……………………………………………………
…………………p.6

A. PRODUCT ANALYSIS
ASSESSMENT……………………………………………p.7

1.  Product Chemistry and
Composition…………………………………………….p.7

2.  Analysis and Certification of
Limits……………………………………………..p.7

3.  Physical and Chemical
Characteristics…………………………………………..p.8

B.  HUMAN HEALTH
ASSESSMENT………………………………………………..p.8

			1.  Toxicological Hazard
Assessment……………………………………………….p.8

			2.  Dose
Response………………………………………………………
………….p.10

3.  Dietary Exposure and Risk
Characterization………………………………..….p.10

			4.  Drinking Water Exposure and Risk
Characterization…………………….…….p.11

			5.	Acute and Chronic Dietary Exposure and Risks for Sensitive

                       Subpopulations, Particularly Infants and
Children………………………….…p.11

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

Characterization………………………………………………
……………..…p.11

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

and
Inhalation……………………………………………………
……………..p.12

			8.  Cumulative
Effects………………………………………………………
……...p.12

			9.  Risk
Characterization………………………………………………
…………...p.12

		C.  ENVIRONMENTAL
ASSESSMENT……………………………………………..p.12

			1.  Summary of Non-Target Organism Testing and Waiver
Rationales……….…..p.12

                  2.  Environmental Fate and
Groundwater……………………………………….....p.13

                 	3.  Ecological Exposure and Risk
Characterization………………………….…….p.13

                  4.  Threatened and Endangered Species
Assessment………………………....……p.13

V.     ENVIRONMENTAL
JUSTICE………………………………………………………
…p.14

VI.    RISK MANAGEMENT AND REGISTRATION
DECISIONS………………………..p.14

A. DETERMINATION OF
ELIGIBILITY……………………………………………p.14

B. REGULATORY
DECISION……………………………………………………….
p.14

C.
LABELING………………………………………………………
…………………p.15

VII.   ACTIONS REQUIRED BY THE
REGISTRANT……………………………………...p.15

A. REPORTING OF ADVERSE EFFECTS AND HYPERSENSITIVITY

INCIDENTS………………………………………………………
………….…….p.15

VIII.  GLOSSARY OF ACRONYMS AND
ABBREVIATIONS………………………….…p.16

IX.    BIBLIOGRAPHY STUDIES SUBMITTED IN SUPPORT OF THIS

REGISTRATION……….…………………………………………
……………….……p.16

		A. STUDIES SUBMITTED IN SUPPORT OF THIS
REGISTRATION…………….p.17

		B. EPA RISK ASSESSMENT
MEMORANDA…...………………………………….p.18

APPENDIX-BIOCHEMICAL PESTICIDE DATA
REQUIREMENTS……………………p.20

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 hornets and wasps, particularly 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.  In
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. Neither acute, sub-chronic, chronic, immune,
or endocrine data, nor any 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 should 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 other wasps are active.  Moreover,
given a lack of acute toxicological endpoints and the fact 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.  Based on the
information submitted, EPA has made “No Effect” (NE) determinations
for direct and indirect effects to listed threatened and endangered
species and their habitat with regard to 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.”  During this
process, no comments were received.  Accordingly, the preliminary
decision to register 2-Methyl-1-butanol is affirmed.  The basis for the
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 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).

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 for hornets and certain wasps,
particularly yellowjackets.  (Yellowjackets are a subset of predatory
wasps, and are often referred to distinctly in the literature.)

 		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.  In addition, on December 15, 2009, EPA provided the
opportunity for a 30-day comment period on the Agency’s draft risk
assessment and intention to register this pesticide product.  EPA has
not received any comment on this proposed action.

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 fragrances and flavors in processed foods.  The
attractant quality of the active ingredient 2-Methyl-1-butanol is
attributed to its redolence.

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 were 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 III 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 III 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.  The information submitted
supports the conclusion that 2-Methyl-1-butanol is not mutagenic.

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 is in the process of issuing test orders for endocrine effects.  The
schedule for issuance of test orders, and details regarding status is
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 in the subject
pesticide product 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 processed foods.  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 extent
that there may be 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 a new active
ingredient 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
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 was subject
to a 30-day comment period as a new active ingredient with both outdoor
uses and residential uses.  No comments were received during that
comment period.

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 information for
2-Methyl-1-butanol demonstrate that it is effectively Toxicity Category
IV for all routes of exposure, except for Primary Eye Irritation, which
is effectively Toxicity Category III.  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 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 2-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.

Notwithstanding 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

2-Methyl-1-butanol		           					Page   PAGE  3

Biopesticide Registration Action Document

 PAGE


[Federal Register Volume 85, Number 119 (Friday, June 19, 2020)]
[Proposed Rules]
[Pages 37057-37059]
[FR Doc No: 2020-13222]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR 83

[EPA-HQ-OAR-2020-00044; FRL 10011-13-OAR]
RIN 2060-AU51

Increasing Consistency and Transparency in Considering Benefits
and Costs in the Clean Air Act Rulemaking Process; Extension of Comment
Period and Public Hearing

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed rulemaking; extension of comment period and
notification of public hearing.

-----------------------------------------------------------------------

SUMMARY: On June 11, 2020, the Environmental Protection Agency (EPA)
published the proposed rulemaking ``Increasing Consistency and
Transparency in Considering Benefits and Costs in the Clean Air Act
Rulemaking Process.'' The EPA is extending the comment period on the
proposed rulemaking. The EPA is also announcing that a virtual public
hearing

will be held for the proposed rulemaking.

DATES:
    Comments: The comment period for the proposed rulemaking published
June 11, 2020 (85 FR 35612), is extended. The EPA must receive comments
on the proposed action on or before August 3, 2020.
    Public hearing: The EPA will hold a virtual public hearing on July
1, 2020. Please refer to the SUPPLEMENTARY INFORMATION section for
additional information on the public hearing.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OAR-2020-00044, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov/
(our preferred method). Follow the online instructions for submitting
comments.
    Instructions: All submissions received must include the Docket ID
No. EPA-HQ-OAR-2020-00044 for this rulemaking. Comments received may be
posted without change to https://www.regulations.gov/, including any
personal information provided. For detailed instructions on sending
comments and additional information on the rulemaking process, see the
``Public Participation'' heading of the SUPPLEMENTARY INFORMATION
section of this document. Out of an abundance of caution for members of
the public and our staff, the EPA Docket Center and Reading Room was
closed to public visitors on March 31, 2020, to reduce the risk of
transmitting COVID-19. Our Docket Center staff will continue to provide
remote customer service via email, phone, and webform. We encourage the
public to submit comments via https://www.regulations.gov or email, as
there is a temporary suspension of mail delivery to EPA, and no hand
deliveries are currently accepted. For further information on EPA
Docket Center services and the current status, please visit us online
at https://www.epa.gov/dockets.
    Virtual Public Hearing. The virtual public hearing will be held via
teleconference July 1, 2020. Refer to the SUPPLEMENTARY INFORMATION
section below for additional information.

FOR FURTHER INFORMATION CONTACT: Leif Hockstad, Office of Air Policy
and Program Support, Office of Air and Radiation, Environmental
Protection Agency, Mail Code 6103A, 1200 Pennsylvania Avenue NW,
Washington, DC 20460;<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This document extends the public comment
period for the proposed rulemaking to ensure that the public has
sufficient time to review and comment on the proposal. The comment
period on the proposed rulemaking will close on August 3, 2020.
    The EPA is proposing processes that it would be required to
undertake in promulgating regulations under the CAA to ensure that
information regarding the benefits and costs of regulatory decisions is
provided and considered in a consistent and transparent manner. The
public hearing will provide interested parties the opportunity to
present data, views, or arguments concerning EPA's proposed
requirements for benefits and costs analyses for CAA rulemakings.
Written statements and supporting information submitted during the
comment period will be considered with the same weight as any oral
comments and supporting information presented at the public hearings.
    Written Comments. Submit your comments, identified by Docket ID No.
EPA-HQ-OAR-2020-00044, at https://www.regulations.gov (our preferred
method), or the other methods identified in the ADDRESSES section. Once
submitted, comments cannot be edited or removed from the docket. The
EPA may publish any comment received to its public docket. Do not
submit electronically any information you consider to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Multimedia submissions (audio, video, etc.) must
be accompanied by a written comment. The written comment is considered
the official comment and should include discussion of all points you
wish to make. The EPA will generally not consider comments or comment
contents located outside of the primary submission (i.e., on the web,
cloud, or other file sharing system). For additional submission
methods, the full EPA public comment policy, information about CBI or
multimedia submissions, and general guidance on making effective
comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
    The EPA is temporarily suspending its Docket Center and Reading
Room for public visitors to reduce the risk of transmitting COVID-19.
Written comments submitted by mail are temporarily suspended and no
hand deliveries will be accepted. Our Docket Center staff will continue
to provide remote customer service via email, phone, and webform. We
encourage the public to submit comments via https://www.regulations.gov. For further information and updates on EPA Docket
Center services, please visit us online at https://www.epa.gov/dockets.
    The EPA continues to carefully and continuously monitor information
from the Centers for Disease Control and Prevention (CDC), local area
health departments, and our Federal partners so that we can respond
rapidly as conditions change regarding COVID-19.
    Participation in Virtual Public Hearing. Please note that EPA is
deviating from its typical approach because the President has declared
a national emergency. Because of current CDC recommendations, as well
as state and local orders for social distancing to limit the spread of
COVID-19, EPA cannot hold in-person public meetings at this time. The
EPA will begin pre-registering speakers and attendees for the hearing
upon publication of this document in the Federal Register. The EPA will
accept registrations on an individual basis. To register to speak at
the virtual hearing, individuals may use the online registration form
available via EPA's Increasing Consistency and Transparency in
Considering Costs and Benefits in the Rulemaking Process web page for
this hearing (https://www.epa.gov/environmental-economics/increasing-consistency-and-transparency-considering-costs-and-benefits) or contact
Leif Hockstad at<PHONE_NUMBER> or<EMAIL_ADDRESS>The last day
to pre-register to speak at the hearing will be June 26, 2020. On June
30, 2020, the EPA will post a general agenda for the hearing that will
list pre-registered speakers in approximate order at: https://www.epa.gov/environmental-economics/increasing-consistency-and-transparency-considering-costs-and-benefits.
    The EPA will make every effort to follow the schedule as closely as
possible on the day of the hearing; however, please plan for the
hearing to run either ahead of schedule or behind schedule.
Additionally, requests to speak will be taken the day of the hearing at
the end of each session as timing allows. The EPA will make every
effort to accommodate all speakers.
    Each commenter will have 5 minutes to provide oral testimony. The
EPA recommends submitting the text of your oral comments as written
comments to the rulemaking docket. The EPA may ask clarifying questions
during the oral presentations but will not respond to the presentations
at that time. Written statements and supporting information submitted
during the comment period will be considered with the same weight as
oral comments and supporting information presented at the public
hearing.

    The EPA is also asking hearing attendees to pre-register for the
hearing, even those who don't intend to provide testimony. This will
help the EPA ensure that sufficient phone lines will be available.
    Please note that any updates made to any aspect of the hearing
logistics, including potential additional sessions, will be posted
online at the EPA's Increasing Consistency and Transparency in
Considering Costs and Benefits in the Rulemaking Process website
(https://www.epa.gov/environmental-economics/increasing-consistency-and-transparency-considering-costs-and-benefits). While the EPA expects
the hearing to go forward as set forth above, please monitor our
website or contact the person listed in the FOR FURTHER INFORMATION
CONTACT section to determine if there are any updates.
    If you require the services of a translator or special
accommodations such as audio description, please pre-register for the
hearing and describe your needs by June 26, 2020. EPA may not be able
to arrange accommodations without advanced notice.

How can I get copies of the proposed action and other related
information?

    The EPA has also established the official public docket for the
proposed action under Docket ID No. EPA-HQ-OAR-2020-00044. A copy of
the proposed action is available at https://www.epa.gov/environmental-economics/increasing-consistency-and-transparency-considering-costs-and-benefits, and any detailed information related to the proposed
action will be available in the public docket prior to the public
hearings. Verbatim transcripts of the hearings and written statements
will be included in the rulemaking docket.

John Shoaff,
Director, Office of Air Policy and Program Support.
[FR Doc. 2020-13222 Filed 6-18-20; 8:45 am]
BILLING CODE 6560-50-P


Public Comments on Proposed Significant New Use Rule (20-4.B)
and EPA Responses  -  Public Docket EPA-HQ-OPPT-2020-0138

EPA received public comments from two identifying entities on the proposed rule. The Agency's responses are described below. In addition, EPA received one anonymous comment. It was general in nature and did not pertain to the proposed rule; therefore, no response is required.
Comment Specific to the SNUR for PMN P-18-381
Comment: One commenter noted that the SNUR for the chemical substance which was the subject of P-18-381 identifies as a significant new use "manufacture or processing in a manner that results in inhalation exposure." However, based on information in the premanufacture notice (PMN) submission and discussions with EPA during the PMN review period, inhalation exposure was expected and assessed under the intended conditions of use. The commenter recommended that EPA restate this significant new use to avoid confusion.
Response:  EPA agrees with the commenter that this significant new use was included erroneously. This term has been removed from the final SNUR. Instead, EPA is designating manufacture or processing without respiratory protection as a significant new use.
Clarification on Chemicals Subject to the Proposed Rule
Comment: One commenter noted that in Unit IV of the proposed rule, the first sentence states "EPA is proposing significant new use and recordkeeping requirements for chemical substances in 40 CFR part 721, subpart E", which contains a detailed list of many chemicals. However, just a few paragraphs following this statement, the proposed rule states that only three substances (P-18-59, P-18-60, and P-18-381) are subject to the proposed rules. It is later stated in Unit X, paragraph A that "This proposed rule would establish SNURs for 3 new chemical substances that were the subject of PMNs". The commenter suggested that the language in Unit IV of the proposed rule should be revised to clarify that the proposed rule is meant to add these three chemicals to the list in 40 CFR part 721.
Response: EPA appreciates the commenter's feedback. The first sentence of Unit IV was revised for clarity in subsequent proposed SNUR notices. Since this comment pertains only to language in the proposed rule and not to language in the final rule or the regulatory text of these SNURs, no changes to the final rule are needed based on the comment.


[Federal Register: March 22, 2006 (Volume 71, Number 55)]
[Rules and Regulations]
[Page 14386-14388]
[DOCID:fr22mr06-12]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2005-NV-0002, FRL-8040-8]

Revisions to the Nevada State Implementation Plan, Washoe County
District Board of Health

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

-----------------------------------------------------------------------

SUMMARY: EPA is approving revisions to the Washoe County District Board
of Health (WCDBH) portion of the Nevada State Implementation Plan
(SIP). The WCDBH revisions concern particulate matter (PM-10) emissions
from street sanding operations and from street sweeping operations. We
are approving local rules under the Clean Air Act as amended in 1990
(CAA or the Act).

DATES: This rule is effective on May 22, 2006 without further notice,
unless EPA receives adverse comments by April 21, 2006. If we receive
such comment, we will publish a timely withdrawal in the Federal
Register to notify the public that this rule will not take effect.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2005-NV-0002, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions.
     E-mail<EMAIL_ADDRESS>     Mail or deliver: Andrew Steckel (Air-4), U.S.
Environmental Protection Agency Region IX, 75 Hawthorne Street, San
Francisco, CA 94105.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://www.regulations.gov,

including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through http://www.regulations.gov or e-mail.

http://www.regulations.gov is an ``anonymous access'' system, and EPA will not

know your identity or contact information unless you provide it in the
body of your comment. If you send e-mail directly to EPA, your e-mail
address will be automatically captured and included as part of the
public comment. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment.
    Docket: The index to the docket for this action is available
electronically at http://www.regulations.gov and in hard copy at EPA Region

IX, 75 Hawthorne Street, San Francisco, California. While all documents
in the docket are listed in the index, some information may be publicly
available only at the hard copy location (e.g., copyrighted material),
and some may not be publicly available in either location (e.g., CBI).
To inspect the hard copy materials, please schedule an appointment
during normal business hours with the contact listed in the FOR FURTHER
INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Al Petersen, Rulemaking Office (AIR-
4), U.S. Environmental Protection Agency, Region IX,<PHONE_NUMBER>,
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. The State's Submittal
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What is the purpose of the submitted rules?
II. EPA's Evaluation and Action
    A. How is EPA evaluating the rules?
    B. Do the rules meet the evaluation criteria?
    C. Public Comment and Final Action
III. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rules did the State submit?

    Table 1 lists the rules we are approving with the dates that they
were adopted by the local air agency and submitted by the Nevada
Division of Environmental Protection.

                               Table 1.--Submitted Rules for Direct Final Approval
----------------------------------------------------------------------------------------------------------------
              Local agency                 Rule No.           Rule title              Adopted        Submitted
----------------------------------------------------------------------------------------------------------------
WCDBH..................................      040.031   Street Sanding Operations        02/27/02        08/05/02
WCDBH..................................      040.032   Street Sweeping                  02/27/02        08/05/02
                                                       Operations.
----------------------------------------------------------------------------------------------------------------

    On February 6, 2003, the submittals of August 5, 2002 were found by
operation of law to meet the completeness criteria.

B. Are there other versions of these rules?

    There are no versions of Rules 040.031 and 040.032 in the SIP.

C. What is the purpose of the submitted rules?

    Section 110(a) of the CAA requires states to submit regulations
that control volatile organic compounds, oxides of nitrogen,
particulate matter (PM-10), and other air pollutants which harm human
health and the environment. These rules were developed as part of the
local agency's program to control emissions of PM-10.
    The purposes of the new rules are as follows:
     Rule 040.031 establishes the following specifications for
de-icing sand: (a) Durability index greater than 75; (b) hardness index
less than 33%; (c) fines smaller than 100 mesh less than 4.0%; and (d)
fines smaller than 200 mesh less than 2.5%.
     Rule 040.032 establishes the following standards for
street sweeping: (a) Certified street sweepers are equipment purchased
or leased after February 1, 2002; (b) equipment must be maintained in
accordance with manufacturer's specifications; (c) sanding events must
be followed by street sweeping within four days or as soon as weather
and road conditions permit; and (d) routine street sweeping not related
to sanding events must be done at least once per month.
    The TSD has more information about these rules.

II. EPA's Evaluation and Action

A. How is EPA evaluating the rules?

    Generally, SIP rules must be enforceable (see section 110(a) of the
CAA) and must not relax existing requirements (see sections 110(l) and
193). The WCDBH regulates a serious PM-10 nonattainment area;
therefore, significant sources of PM-10 must apply BACM/BACT (see
section 189(b)(1)(B)). Rules 040.031 and 040.032 regulate a significant
source of PM-10 according to the PM-10 State Implementation Plan for
the Truckee Meadows Air Basin (August 2002) (2002 Plan) and must
fulfill the requirements of BACM/BACT.
    Guidance and policy documents that we used to help evaluate
enforceability requirements consistently include the following:
     Requirements for Preparation, Adoption, and Submittal of
Implementation Plans, U.S. EPA, 40 CFR part 51.
     Guidance Document for Correcting Common VOC & Other Rule
Deficiencies, EPA Region IX (August 21, 2001). (The Little Bluebook)
     Addendum to the General Preamble for the Implementation of
Title I of the Clean Air Act Amendments of 1990, U. S. EPA, 59 FR 41998
(August 16, 1994).
     Fugitive Dust Background Document and Technical
Information Document for Best Available Control Measures, EPA-450/2-92-
004 (September 1992).
     Guidance Document for Selecting Antiskid Materials Applied
to Ice- and Snow-Covered Roadways, EPA-450/3-90-007 (July 1991).

B. Do the rules meet the evaluation criteria?

    We believe WCDBH Rules 040.031 and 040.032 are consistent with the
relevant policy and guidance regarding enforceability, SIP relaxations,
and fulfilling the requirements of BACM/BACT.
    The rules are discussed further in the TSD.

C. Public Comment and Final Action

    As authorized in section 110(k)(3) of the CAA, EPA is fully
approving the submitted rules WCDBH Rules 040.031 and 040.032 because
we believe they fulfill all relevant requirements. We do not think
anyone will object to this approval, so we are finalizing it without
proposing it in advance. However, in the Proposed Rules section of this
Federal Register, we are simultaneously proposing approval of the same
submitted rules. If we receive adverse comments by April 21, 2006, we
will publish a timely withdrawal in the Federal Register to notify the
public that the direct final approval will not take effect and we will
address the comments in a subsequent final action based on the
proposal. If we do not receive timely adverse comments, the direct
final approval will be effective without further notice on May 22,
2006. This will incorporate these rules into the federally enforceable
SIP.
    However, in the Proposed Rules section of this Federal Register, we
are simultaneously proposing approval of the same submitted rules. If
we receive adverse comments by April 21, 2006, we will publish a timely
withdrawal in the Federal Register to notify the public that the direct
final approval will not take effect and we will address the comments in
a subsequent final action based on the proposal. If we do not receive
timely adverse comments, the direct final approval will be effective
without further notice on May 22, 2006. This will incorporate these
rules into the federally enforceable SIP.
    Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment.

III. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves state law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by state law.
Accordingly, the Administrator certifies that this rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this rule approves pre-existing requirements under state law and does
not impose any additional enforceable duty beyond that required by
state law, it does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
    This rule also does not have tribal implications because it will
not have a substantial direct effect on one or more

Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000). This action also
does not have Federalism implications because it does not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This
action merely approves a state rule implementing a Federal standard,
and does not alter the relationship or the distribution of power and
responsibilities established in the Clean Air Act. This rule also is
not subject to Executive Order 13045 ``Protection of Children from
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23,
1997), because it is not economically significant.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not
impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
    The Congressional Review Act, 5 U.S.C. section 801 et seq., as
added by the Small Business Regulatory Enforcement Fairness Act of
1996, generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. EPA will submit a report containing this
rule and other required information to the U.S. Senate, the U.S. House
of Representatives, and the Comptroller General of the United States
prior to publication of the rule in the Federal Register. A major rule
cannot take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
section 804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by May 22, 2006. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action may not be challenged later in proceedings
to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter, Reporting
and recordkeeping requirements.

    Dated: February 16, 2006.
Wayne Nastri,
Regional Administrator, Region IX.

0
Part 52, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart DD--Nevada

0
2. Section 52.1470 is amended by adding paragraph (c)(55) to read as
follows:

Sec.  52.1470  Identification of plan.

* * * * *
    (c) * * *
    (55) The following plan revision and regulations were submitted on
August 5, 2002, by the Governor's designee.
    (i) Incorporation by reference.
    (A) Washoe County District Board of Health.
    (1) Rules 040.031 and 040.032, adopted on February 27, 2002.
* * * * *
[FR Doc. 06-2697 Filed 3-21-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 149 (Monday, August 3, 2020)]
[Rules and Regulations]
[Pages 46556-46559]
[FR Doc No: 2020-15772]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

48 CFR Parts 1539 and 1552

[EPA-HQ-OARM-2018-0743; FRL-10011-94-OMS]

Environmental Protection Agency Acquisition Regulation (EPAAR);
Open Source Software

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is adding a new
clause to the EPAAR addressing open source software requirements,
including EPA's ability to share open source software developed under
its procurements.

DATES: This final rule is effective on August 3, 2020.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-HQ-OARM-2018-0743. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g., CBI or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
internet and will be publicly available only in hard copy form.
Publicly available docket materials are available electronically
through http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Thomas Valentino, Policy, Training,
and Oversight Division, Office of Acquisition Solutions (3802R),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The EPA is writing a new EPAAR clause to address open source
software requirements at EPA, so that the EPA can share custom-
developed code as open source code developed under its procurements, in
accordance with Office of Management and Budget's (OMB) Memorandum M-
16-21, Federal Source Code Policy: Achieving Efficiency, Transparency,
and Innovation through Reusable and Open Source Software. In meeting
the requirements of Memorandum M-16-21 the EPA will be providing an
enterprise code inventory indicating if the new code (source code or
code) was custom-developed for, or by, the agency; or if the code is
available for Federal reuse; or if the code is available publicly as
open source code; or if the code cannot be made available due to
specific exceptions. On October 18, 2019 (84 FR 55894) EPA sought
comments on the proposed rule and received four comments. One commenter
stated that a single location to access open-source code would be
easier to access and manage. The EPA agrees, and participates in the
https://code.gov/ platform provided by the General Services
Administration (GSA) to host open-source code. Another commenter stated
that protecting our nation's computer systems should be a high

priority, and the EPA agrees. The EPA also agrees with the commenter
who stated that this rule strikes a balance between government benefit
and risk. The EPA addressed the broad final comment by providing
procedures at https://www.usa.gov/complaint-against-government that
outlines how to file complaints.

II. Final Rule

    The final rule creates EPA Acquisition Regulation (EPAAR) Part
1539, Acquisition of Information Technology, and adds Subpart 1539.2,
Open Source Software; and Sec.  1539.2071, Contract clause. EPAAR
Subpart 1552.2, Texts of Provisions and Clauses, is amended by adding
EPAAR Sec.  1552.239-71, Open Source Software.
    1. EPAAR Subpart 1539.2 adds the new subpart.
    2. EPAAR Sec.  1539.2071 adds the prescription for use of Sec.
1552.239-71 in all procurements where open-source software development/
custom development of software will be required.
    3. EPAAR Sec.  1552.239-71, Open Source Software, provides the
terms and conditions for open source software code development and use.

III. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order (E.O.) 12866 (58 FR 51735, October 4, 1993)
and therefore, not subject to review under the E.O.

B. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
No information is collected under this action.

C. Regulatory Flexibility Act (RFA), as Amended by the Small Business
Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et
seq.

    The Regulatory Flexibility Act generally requires an agency to
prepare a regulatory flexibility analysis of any rule subject to notice
and comment rulemaking requirements under the Administrative Procedure
Act or any other statute; unless the agency certifies that the rule
will not have a significant economic impact on a substantial number of
small entities. Small entities include small businesses, small
organizations, and small governmental jurisdictions.
    For purposes of assessing the impact of today's final rule on small
entities, ``small entity'' is defined as: (1) A small business that
meets the definition of a small business found in the Small Business
Act and codified at 13 CFR 121.201; (2) a small governmental
jurisdiction that is a government of a city, county, town, school
district or special district with a population of less than 50,000; and
(3) a small organization that is any not-for-profit enterprise which is
independently owned and operated and is not dominant in its field.
    After considering the economic impacts of this rule on small
entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. This action
creates a new EPAAR clause and does not impose requirements involving
capital investment, implementing procedures, or record keeping. This
rule will not have a significant economic impact on small entities.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, Local, and Tribal
governments and the private sector.
    This rule contains no Federal mandates (under the regulatory
provisions of the Title II of the UMRA) for State, Local, and Tribal
governments or the private sector. The rule imposes no enforceable duty
on any State, Local or Tribal governments or the private sector. Thus,
the rule is not subject to the requirements of Sections 202 and 205 of
the UMRA.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and Local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
    This rule does not have federalism implications. It will not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government as
specified in Executive Order 13132.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' This rule does not have
tribal implications as specified in Executive Order 13175.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    Executive Order 13045, entitled ``Protection of Children from
Environmental Health and Safety Risks'' (62 FR 19885, April 23, 1997),
applies to any rule that: (1) Is determined to be economically
significant as defined under Executive Order 12886, and (2) concerns an
environmental health or safety risk that may have a proportionate
effect on children. This rule is not subject to Executive Order 13045
because it is not an economically significant rule as defined by
Executive Order 12866, and because it does not involve decisions on
environmental health or safety risks.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This final rule is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution of Use'' (66 FR 28335 (May 22, 2001), because it is not a
significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act of 1995 (NTTAA)

    Section 12(d) (15 U.S.C 272 note) of NTTA, Public Law 104-113,
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures and business practices) that are developed or adopted by
voluntary consensus standards bodies. The NTTA directs EPA to provide
Congress, through OMB,

explanations when the Agency decides not to use available and
applicable voluntary consensus standards.
    This rulemaking does not involve technical standards. Therefore,
EPA is not considering the use of any voluntary consensus standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order (E.O.) 12898 (59 FR 7629 (February 16, 1994)
establishes federal executive policy on environmental justice. Its main
provision directs federal agencies, to the greatest extent practicable
and permitted by law, to make environmental justice part of their
mission by identifying and addressing, as appropriate,
disproportionately high and adverse human health or environmental
effects of their programs, policies, and activities on minority
populations and low-income populations in the United States.
    EPA has determined that this final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it does not
affect the level of protection provided to human health or the
environment. This rulemaking does not involve human health or
environmental effects.

List of Subjects in 48 CFR Parts 1539 and 1552

    Environmental protection, Government procurement, Reporting and
recordkeeping requirements.

Kimberly Patrick,
Director, Office of Acquisition Solutions.

    For the reasons set forth in the preamble, EPA adds 48 CFR part
1539 and amends 48 CFR part 1552 as follows:

0
1. Add part 1539 to read as follows:

PART 1539--ACQUISITION OF INFORMATION TECHNOLOGY

Subpart 1539.2--Open Source Software

Sec.
1539.2071 Contract clause

    Authority:  5 U.S.C. 301 and 41 U.S.C. 418b.

Subpart 1539.2--Open Source Software

Sec.  1539.2071   Contract clause.

    (a) Contracting Officers shall use clause 1552.239-71, Open Source
Software, for all procurements where open-source software development/
custom development of software will be required; including, but not
limited to, multi-agency contracts, Federal Supply Schedule orders,
Governmentwide Acquisition Contracts, interagency agreements,
cooperative agreements and student services contracts.
    (b) In addition to clause 1552.239-71, Contracting Officers must
also select the appropriate version * of Federal Acquisition Regulation
(FAR) clause 52.227-14, Rights in Data--General, to include in the
subject procurement in accordance with FAR 27.409. (* Important note:
Alternate IV of clause 52.227-14 is NOT suitable for open-source
software procurement use because it gives the contractor blanket
permission to assert copyright.)

PART 1552--SOLICITATION PROVISIONS AND CONTRACT CLAUSES

0
4. Authority: The authority citations for part 1552 continue to read as
follows:

    Authority:  5 U.S.C. 301 and 41 U.S.C. 418b.

0
5. Amend Subpart 1552.2, Texts of Provisions and Clauses, by adding
Sec.  1552.239-71 to read as follows:

Sec.  1552.239-71   Open Source Software.

    As prescribed in Sec.  1539.2071, insert the following clause:

Open Source Software (AUG 2020)

    (a) Definitions.
    ``Custom-Developed Code'' means code that is first produced in
the performance of a federal contract or is otherwise fully funded
by the federal government. It includes code, or segregable portions
of code, for which the government could obtain unlimited rights
under Federal Acquisition Regulation (FAR) Part 27 and relevant
agency FAR Supplements. Custom-developed code also includes code
developed by agency employees as part of their official duties.
Custom-developed code may include, but is not limited to, code
written for software projects, modules, plugins, scripts, middleware
and Application Programming Interfaces (API); it does not, however,
include code that is truly exploratory or disposable in nature, such
as that written by a developer experimenting with a new language or
library.
    ``Open Source Software (OSS)'' means software that can be
accessed, used, modified and shared by anyone. OSS is often
distributed under licenses that comply with the definition of ``Open
Source'' provided by the Open Source Initiative at https://opensource.org/osd or equivalent, and/or that meet the definition of
``Free Software'' provided by the Free Software Foundation at:
https://www.gnu.org/philosophy/free-sw.html or equivalent.
    ``Software'' means: (i) Computer programs that comprise a series
of instructions, rules, routines or statements, regardless of the
media in which recorded, that allow or cause a computer to perform a
specific operation or series of operations; and (ii) recorded
information comprising source code listings, design details,
algorithms, processes, flow charts, formulas and related material
that would enable the computer program to be produced, created or
compiled. Software does not include computer databases or computer
software documentation.
    ``Source Code'' means computer commands written in a computer
programming language that is meant to be read by people. Generally,
source code is a higher-level representation of computer commands
written by people, but must be assembled, interpreted or compiled
before a computer can execute the code as a program.
    (b)(1) Policy. It is the EPA policy that new custom-developed
code be made broadly available for reuse across the federal
government, subject to the exceptions provided in (b)(3). The policy
does not apply retroactively so it does not require existing custom-
developed code also be made available for Government-wide reuse or
as OSS. However, making such code available for government-wide
reuse or as OSS, to the extent practicable, is strongly encouraged.
The EPA also supports the Office of Management and Budget's (OMB)
Federal Source Code Policy provided in OMB Memorandum M-16-21,
Federal Source Code Policy: Achieving Efficiency, Transparency, and
Innovation through Reusable and Open Source Software, by:
    (i) Providing an enterprise code inventory (e.g., code.json
file) that lists new and applicable custom-developed code for, or
by, the EPA;
    (ii) Indicating whether the code is available for Federal reuse;
or
    (iii) Indicating if the code is available publicly as OSS.
    (2) Exemption: Source code developed for National Security
Systems (NSS), as defined in 40 U.S.C. 11103, is exempt from the
requirements herein.
    (3) Exceptions: Exceptions may be applied in specific instances
to exempt EPA from sharing custom-developed code with other
government agencies. Any exceptions used must be approved and
documented by the Chief Information Officer (CIO) or his or her
designee for the purposes of ensuring effective oversight and
management of IT resources. For excepted software, EPA must provide
OMB a brief narrative justification for each exception, with
redactions as appropriate. Applicable exceptions are as follows:
    (i) The sharing of the source code is restricted by law or
regulation, including--but not limited to--patent or intellectual
property law, the Export Asset Regulations, the International
Traffic in Arms Regulation and the federal laws and regulations
governing classified information.
    (ii) The sharing of the source code would create an identifiable
risk to the detriment of national security, confidentiality of
government information or individual privacy.

    (iii) The sharing of the source code would create an
identifiable risk to the stability, security or integrity of EPA's
systems or personnel.
    (iv) The sharing of the source code would create an identifiable
risk to EPA mission, programs or operations.
    (v) The CIO believes it is in the national interest to exempt
sharing the source code.
    (c) The Contractor shall deliver to the Contracting Officer (CO)
or Contracting Officer's Representative (COR) the underlying source
code, license file, related files, build instructions, software
user's guides, automated test suites, and other associated
documentation as applicable.
    (d) In accordance with OMB Memorandum M-16-21 the Government
asserts its unlimited rights--including rights to reproduction,
reuse, modification and distribution of the custom source code,
associated documentation, and related files--for reuse across the
federal government and as open source software for the public. These
unlimited rights described above attach to all code furnished in the
performance of the contract, unless the parties expressly agree
otherwise in the contract.
    (e) The Contractor is prohibited from reselling code developed
under this contract without express written consent of the EPA
Contracting Officer. The Contractor must provide at least 30 days
advance notice if it intends to resell code developed under this
contract.
    (f) Technical guidance for EPA's OSS Policy should conform with
the ``EPA's Open Source Code Guidance'' that will be maintained by
the Office of Mission Support (OMS) at https://developer.epa.gov/guide/open-source-code/ or equivalent.
    (g) The Contractor shall identify all deliverables and asserted
restrictions as follows:
    (1) The Contractor shall use open source license either:
    (i) Identified in the contract, or
    (ii) developed using one of the following licenses: (a) Creative
Commons Zero (CC0); (b) MIT license; (c) GNU General Public License
version 3 (GPL v3); (4) Lesser General Public License 2.1 (LGPL-
2.1); (5) Apache 2.0 license; or (6) other open source license
subject to Agency approval.
    (2) The Contractor shall provide a copy of the proposed
commercial license agreement to the Contracting Officer prior to
contracting for commercial data/software.
    (3) The Contractor shall identify any data that will be
delivered with restrictions.
    (4) The Contractor shall deliver the data package as specified
by the EPA.
    (5) The Contractor shall deliver the source code to the EPA-
specified version control repository and source code management
system.
    (h) The Contractor shall comply with software and data rights
requirements and provide all licenses for software dependencies as
follows:
    (1) The Contractor shall ensure all deliverables are
appropriately marked with the applicable restrictive legends.
    (2) The EPA is deemed to have received unlimited rights when
data or software is delivered by the Contractor with restrictive
markings omitted.
    (3) If the delivery is made with restrictive markings that are
not authorized by the contract, then the marking is characterized as
``nonconforming.'' In accordance with Federal Acquisition Regulation
(FAR) 46.407, Nonconforming supplies or services, the Contractor
will be given the chance to correct or replace the nonconforming
supplies within the required delivery schedule. If the Contractor is
unable to deliver conforming supplies, then the EPA is deemed to
have received unlimited rights to the nonconforming supplies.
    (i) The Contractor shall include this clause in all subcontracts
that include custom-developed code requirements.

(End of clause)

[FR Doc. 2020-15772 Filed 7-31-20; 8:45 am]
BILLING CODE 6560-50-P