BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Salicylic Acid

PC Code: 076602

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

January 10, 2012

TABLE OF CONTENTS

  TOC \o "1-3" \h \z \u    HYPERLINK \l "_Toc313956258"  I.
EXECUTIVE SUMMARY	  PAGEREF _Toc313956258 \h  4

  HYPERLINK \l "_Toc313956259"  II.   	ACTIVE INGREDIENT OVERVIEW
PAGEREF _Toc313956259 \h  5

  HYPERLINK \l "_Toc313956260"  III.  	REGULATORY BACKGROUND	  PAGEREF
_Toc313956260 \h  5

	  HYPERLINK \l "_Toc313956261"  A.  	Classification	  PAGEREF
_Toc313956261 \h  5

	  HYPERLINK \l "_Toc313956262"  B.	Food Clearances/Tolerances	  PAGEREF
_Toc313956262 \h  6

  HYPERLINK \l "_Toc313956263"  IV.  	RISK ASSESSMENT	  PAGEREF
_Toc313956263 \h  6

	  HYPERLINK \l "_Toc313956264"  A.  	Product Analysis Assessment
PAGEREF _Toc313956264 \h  7

	  HYPERLINK \l "_Toc313956265"  B.   Human Health Assessment	  PAGEREF
_Toc313956265 \h  8

	  HYPERLINK \l "_Toc313956266"  C.  	Environmental Assessment	  PAGEREF
_Toc313956266 \h  15

  HYPERLINK \l "_Toc313956267"  V.   ENVIRONMENTAL JUSTICE	  PAGEREF
_Toc313956267 \h  18

  HYPERLINK \l "_Toc313956268"  VI.   RISK MANAGEMENT AND REGISTRATION
DECISIONS	  PAGEREF _Toc313956268 \h  18

	  HYPERLINK \l "_Toc313956269"  A.  	Determination of Eligibility
PAGEREF _Toc313956269 \h  19

	  HYPERLINK \l "_Toc313956270"  B.  	Regulatory Decision	  PAGEREF
_Toc313956270 \h  19

	  HYPERLINK \l "_Toc313956271"  C.  	Labeling	  PAGEREF _Toc313956271
\h  19

  HYPERLINK \l "_Toc313956272"  VII.   ACTIONS REQUIRED OF THE
REGISTRANT	  PAGEREF _Toc313956272 \h  19

	  HYPERLINK \l "_Toc313956273"  A.  	Reporting of Adverse Effects and
Hypersensitivity Incidents	  PAGEREF _Toc313956273 \h  20

  HYPERLINK \l "_Toc313956274"  VIII. GLOSSARY OF ACRONYMS AND
ABBREVIATIONS	  PAGEREF _Toc313956274 \h  20

  HYPERLINK \l "_Toc313956275"  IX. 	BIBLIOGRAPHY STUDIES SUBMITTED IN
SUPPORT OF THESE

 	REGISTRATIONS	  PAGEREF _Toc313956275 \h  21

	  HYPERLINK \l "_Toc313956276"  A.  	Studies Submitted in Support of
Salicylic Acid.	  PAGEREF _Toc313956276 \h  21

	  HYPERLINK \l "_Toc313956277"  B. 	EPA Risk Assessment Memoranda
PAGEREF _Toc313956277 \h  28

	  HYPERLINK \l "_Toc313956278"  C.  	References	  PAGEREF _Toc313956278
\h  28

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

					Angela Gonzales						Lead Science Reviewer

Russell Jones, Ph.D.					Senior Biologist

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

Salicylic Acid is a naturally occurring plant regulator present in most
plants. Data indicate that it triggers immune responses in plants and
acts as a mild antibiotic. Humans consume Salicylic Acid regularly as it
is naturally present in most fruits and vegetables. In its concentrated
state, it is a white crystalline powder with a sweetish acrid taste. It
is known for its many useful ester derivatives and can be found in a
range of commercial products such as antiseptics, preservatives, and
medicines. Salicylic Acid is perhaps best known as the principal
metabolite and component of aspirin. Humans have a long history of
natural exposure to Salicylic Acid without incident.

As an active ingredient, it is intended for use as a treatment for seeds
that are not meant for human or animal consumption. Its mode of action
is as a Systemic Acquired Resistance (SAR) inducer for seedlings –
i.e. a trigger for invoking a seedling’s natural defenses against
pathogens, allowing for greater plant vigor and survivability. Because
there are no residues taken up systemically, and treated seeds are not
allowed for food or feed uses, this seed treatment is not considered to
be a food use.

Negligible dietary exposures to the pesticidal active ingredient
notwithstanding, there are few apparent risks related to regular
exposure to this natural acid. Data from a Dutch Food Consumption Survey
show the average daily intake (ADI) for this chemical has been estimated
to be 0-5 milligrams per day from the consumption of fruits and
vegetables.  Also, consumption of Salicylic Acid in aspirin exposes a
person to greater doses than would any potential residues associated
with seed treatment.  (HSDB, 2008) Furthermore, Salicylic Acid is
approved for use by the U.S. Food and Drug Administration (FDA) as an
indirect food additive under 21 CFR 175.105; and the U.S. Environmental
Protection Agency (EPA or Agency) has approved the use of the chemical
as an ‘other ingredient’ in pesticide products. In sum, no hazards
have been identified yet with regard to any of these regular exposures.

Moreover, data demonstrate that Salicylic Acid poses minimal hazards for
humans and the environment. Acute human health toxicity data indicate
negligible human toxicity for all routes of exposure. Acute nontarget
organism toxicology data indicate marginal toxicity for aquatic
organisms, birds, mammals, insects and plants. Subchronic and chronic
toxicity data suggest no hazard relative to longer term exposures,
although no long-term exposures to Salicylic Acid formulated as a
pesticidal active ingredient are anticipated given that Salicylic Acid
biodegrades rapidly. No human health or environmental risks are
anticipated for Salicylic Acid due to its low toxicity and minimal
opportunity for significant exposure.

On October 1, 2009, the EPA announced a new policy to provide a more
meaningful opportunity for the public to participate in major
registration decisions before they occur. According to this 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 uses; first outdoor
uses; first residential uses; or any other registration actions for
which EPA believes there may be significant public interest.

Consistent with the policy of making registration actions more
transparent, the proposed pesticide products containing Salicylic Acid,
a new active ingredient, are subject to a 30-day comment period. In
addition to containing a new active ingredient, the registration of
these products would result in the first outdoor use for Salicylic Acid.
The docket identification number associated with these registration
actions, EPA-HQ-OPP-2011-0009, can be accessed through  HYPERLINK
"http://www.regulations.gov/" http://www.regulations.gov/ . The
following documents are available for comment in the docket: (1)
Salicylic Acid Biopesticides Registration Action Document; (2) a draft
label for the Manufacturing-use Product, EPA File Symbol 34704-RNLT; and
(3) draft labels for the End-use Products, EPA File Symbols 34704-RNLL
and 34704-RNLA. While a final decision on registration is contingent
upon review and consideration of public comments, EPA presently believes
that, based upon the risk assessment and information submitted in
support of Salicylic Acid, it is in the best interest of the public and
the environment to issue these registrations. The basis for this
preliminary decision can be found in the risk assessment for Salicylic
Acid, which is presented in this document.

II.  ACTIVE INGREDIENT OVERVIEW

Common Name: 			Salicylic Acid

Chemical Names: 		2-Hydroxybenzoic acid, Carboxylic Acid

Trade & Other Names:	Salicylic Acid, SA

CAS Registry Number: 	69-72-7

OPP Chemical Code: 	076602

Type of Pesticide: 		Plant Regulator

 III.  REGULATORY BACKGROUND

On February 2, 2011, EPA published in the Federal Register (76 FR 5805)
a notice announcing that Loveland Products, Inc., c/o Pyxis Consulting,
Inc., 4110 136th St., NW., Gig Harbor, WA 98332, submitted an
application to register a Manufacturing-use Product (MP), EPA File
Symbol 34704-RNLT, and two End-use Products (EPs), EPA File Symbols
34704-RNLL and 34704-RNLA, containing a new active ingredient (Salicylic
Acid) not included in any currently registered products. No comments
were received following publication of the notice.

CLASSIFICATION

Salicylic Acid was classified as a Biochemical Pesticide by the
Classification Committee on November 20, 1997. The Classification
Committee confirmed its nontoxic mode of action, its natural occurrence
in the environment, and its history of exposure to humans and the
environment without known toxicity.

Salicylic Acid is a naturally occurring plant hormone present in all
terrestrial plants. Historically, it has been commercially distilled
from willow bark, where it is found in high concentration. With regard
to its active properties, Salicylic Acid is a plant regulator that has
mediating roles on plant growth, photosynthesis, transpiration, and ion
uptake. When applied to seeds as an active ingredient, Salicylic Acid
acts as a SAR inducer – i.e. it triggers a plants immuno-defense
system to defend against pathogens, allowing for greater survivability
of seedlings.

FOOD CLEARANCES/TOLERANCES

Salicylic Acid is intended for use as a seed treatment for nonfood and
nonfeed uses (i.e. treated seeds are not for animal or human
consumption). Because no residues are systemically expressed through the
planted seed to the fruit and vegetables, the use of Salicylic Acid is
not considered to be a food use.

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,” EPA 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 statements
and are based on the hazard(s) identified from studies and/or other
information submitted to EPA in support of a pesticide registration. The
active ingredient or a 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

Salicylic Acid (2-hydroxybenzoic acid) is an aromatic carboxylic acid
that is commercially derived from the bark of the willow tree. It is a
naturally occurring plant regulator with various roles regulating
photosynthesis and transpiration and mediating plant defenses against
pathogens (U.S. EPA. 2011b.). In purest form, it is a white crystalline
powder with a sweetish acrid flavor. It is used in a variety of topical
cosmetics and pharmaceutical products as a mild antibiotic (HDSB, 2011).
Salicylic Acid is naturally found in significant concentrations in a
wide variety of foods such as apples, plums, grapes, oranges, tomatoes,
cinnamon, oregano, thyme, beer, honey and raisins (HDSB, 2011).

All product chemistry data requirements for Salicylic Acid have been
satisfied. As a manufactured active ingredient, Salicylic Acid extract
is indistinguishable from the plant hormone that is produced naturally
in plants (MRID 47206713). The extract has a high degree of purity and
contains no impurities of toxicological significance (MRID 47206713,
47760931 and 47206714). All data requirements for physical and chemical
characteristics have been adequately addressed (U.S. EPA. 2011b.).

2.  	Analysis and Certification of Limits

The submitted data satisfied the requirements for Analysis and
Certification of Limits. Five-batch analyses and the analytical method
used to determine the purity of Salicylic Acid were examined and
determined to be acceptable by the Agency. The information submitted on
the analyses and certified limits are summarized in Table 1.

TABLE 1. Product Chemistry Data Requirements for Salicylic Acid
Technical (40 CFR § 158.2030)

OSCPP Guideline No. 	Study	Results 	MRID No.

880.1100

880.1200

880.1400	Product identity;

Manufacturing process;

Discussion of formation of impurities	Submitted data satisfy the
requirements for product identity, manufacturing process, and discussion
of formation of impurities.  	47206713

47760931

830.1700	Analysis of samples	Submitted data satisfy the requirements for
analysis of samples. 	47206714

830.1750	Certification of limits	Limits listed in the confidential
statement of formula are acceptable 	47206714

830.1800	Analytical method	Acceptable.	47206714

3.  	Physical and Chemical Characteristics

The Agency has determined that the submitted data adequately describe
the physical and chemical characteristics of Salicylic Acid. See Table 2
below for details.

TABLE 2. Physical and Chemical Properties of Salicylic Acid Technical
(40 CFR § 158.2030)

OCSPP Guideline No. 	Property	Description of Result	MRID No.

830.6302	Color	White	48225202

830.6303	Physical State	Solid crystalline powder	48225202

830.6304	Odor	Odorless	48225202

830.6313	Stability to Normal and Elevated Temperatures, Metals and Metal
Ions	Stable for 14 days at room temperature, degrades slightly (below
certified limits) after 4 days at 54ºC. Data on metals were not
submitted; SA is not stored in or expected to come into contact with
metal or metal ions during storage or use.	48225201

48225202

830.6315	Flammability	Flash point: 315ºF (157ºC)	HSDB, 2008

830.6317	Storage Stability	In progress	48225202

830.6319	Miscibility	N/A: not an emulsifiable liquid that will be
diluted with petroleum solvents.

48225202

830.6320	Corrosion Characteristics	In progress	48225202

830.7000	pH	2.56	48225201

Neutral: 231 nm (ε1 = 6794), 296 nm (ε = 3567)

Basic: 219.5 nm (ε = 7046), 296.5 nm (ε = 3535)

Acidic: 236.5 nm (ε = 8538), 302 nm (ε = 3632)	48225201

48225202

830.7100	Viscosity	N/A: product is a solid	48225202

830.7200	Melting Point/Range	159.3-161.5 ºC	48225202

830.7220	Boiling Point/Range	N/A: SA is a solid	48225202

830.7300	Density	1.429 g/mL	48225202

830.7520	Particle Size, Fiber Length and  Diameter Distribution	N/A: SA
is not water insoluble nor is it a fibrous substance with a diameter ≥
0.1µm.	48225202

830.7550

830.7560

830.7570	Partition Coefficient (n-

Octanol/Water)

Log Pow = 2.1	48225201

48225202

830.7840	Water Solubility	1.71 mg/mL in water

0.05 g/100 mL in hexane

32.12 g/100 mL in methanol

16.02 g/100 mL in n-octanol	48225201

48225202

830.7950	Vapor Pressure	114 Pa at 130ºC

8.2X10-5 mm Hg at 25ºC	48225202

	B.  	HUMAN HEALTH ASSESSMENT

	1.  	Toxicological Hazard Assessment

Adequate mammalian toxicology studies were provided in support of the
registration of Salicylic Acid for each data requirement. Acute
toxicology data indicates that the active ingredient is virtually
nontoxic to mammals, and that there are no toxicological endpoints
relative to its use as a SAR-inducer in plants. Accordingly, the data
submitted demonstrate that the proposed uses of Salicylic Acid pose no
significant risks to human health and support a finding of reasonable
certainty that no harm to the general U.S. population, including infants
and children, will result from exposure to this active ingredient (U.S.
EPA. 2011b; MRIDs 48225203-48225208).

Table 3. Mammalian Toxicology Data for Salicylic Acid Technical (40 CFR
§ 158.2050)

Study/OCSPP Guideline No.	Results	Toxicity Description	MRID No.

Acute oral toxicity (rat)

(870.1100)	LD50 = 890 mg/kg	III	47206707

Acute dermal toxicity (rabbit)

(870.1200)	LD50 > 5,050 mg/kg 	IV	47206711

Acute inhalation toxicity	 (rat)

(870.1300)	LC50 > 2.21 mg/L	IV	47206710

Primary eye irritation (rabbit)

(870.2400)	Moderately irritating	III	47206706

Primary dermal irritation (rabbit)

(870.2500)	Non-irritating	IV	47206709

Dermal sensitization (guinea pig)

(870.2600)	Not a sensitizer	N/A	47206708

Hypersensitivity incidents

(None)	Must be reported	N/A

	90-Day oral toxicity

(870.3100)	Proposed products are nonfood use. Subchronic and chronic
oral toxicity studies were submitted for methyl salicylate and
acetylsalicylic acid, which are rapidly converted to SA and/or an SA
ester in the body. Data indicate negligible toxicity. Risk to humans is
not anticipated based on the lack of repeat oral exposure to SA due to
the use pattern.

48225204

48225206

90-Day dermal toxicity

(870.3250)	Purposeful application and prolonged exposure to the human
skin is not anticipated based on the use pattern (seed treatment).
Significant dermal exposure to handlers/applicators is unlikely as
End-use Product (EP) labels require appropriate personal protective
equipment (PPE) to mitigate dermal exposure. Risk is expected to be
negligible based on the lack of anticipated exposure and dermal
toxicology data.

48225204

48225206

90-Day inhalation toxicity

(870.3465)	Significant repeat inhalation exposure to SA as a gas, vapor
or aerosol is unlikely based on use pattern as a seed treatment and
physical properties of the active ingredient in that it degrades rapidly
in the environment.

48225204

48225206

Mutagenicity-bacterial reverse mutation test (modified Ames)

(870.5100)	Significant human exposure is unlikely based on use pattern
as a seed treatment and rapid biodegradation in the environment. The
risk of mutagenicity is expected to be negligible based on the lack of
anticipated exposure and mutagenicity data.

HSDB, 2011

Mutagenicity-in vitro mammalian cell assay (870.5300 and 870.5375)
Significant human exposure is unlikely based on use pattern as a seed
treatment and rapid biodegradation in the environment. The risk of
mutagenicity is expected to be negligible based on the lack of
anticipated exposure and mutagenicity data.

48225207

Developmental toxicity

 (870.3700)	Significant exposure to female humans is unlikely based on
use pattern as a seed treatment. Significant exposure to
handlers/applicators is unlikely as EP labels require appropriate PPE to
mitigate exposure. Risk is expected to be negligible based on the lack
of anticipated exposure and the available developmental toxicology data.

48225205

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

Acute Oral Toxicity – Rat (OCSPP Guideline 870.1100; MRID No.
47206707):  An acute oral toxicity study shows that the active
ingredient, Salicylic Acid, has an acute oral median lethal dose (LD50)
of greater than 890 milligrams per kilogram (mg/kg) in rats. The study
was found “ACCEPTABLE,” and Salicylic Acid was classified as
TOXICITY CATEGORY III for this route of exposure when used as a seed
treatment.

Acute Dermal Toxicity – Rabbit (OCSPP Guideline 870.1200; MRID No.
47206711):  An acute dermal toxicity study shows that the active
ingredient, Salicylic Acid, has an LD50 of greater than 5,050 mg/kg in
rabbits, which is considered to be virtually nontoxic. Data substantiate
the active ingredient’s relative dermal nontoxicity to both
occupational users and the general public. The study was found
“ACCEPTABLE,” and Salicylic Acid was classified as TOXICITY CATEGORY
IV for this route of exposure when used as a seed treatment.

Acute Inhalation Toxicity – Rat (OCSPP Guideline 870.1300; MRID No.
47206710):  An acute oral inhalation study shows that the active
ingredient, Salicylic Acid, has a median lethal concentration (LC50) of
greater than 2.21 milligrams per liter (mg/L) in rats, which shows no
significant inhalation toxicity. This was the maximum dose rate, and no
toxicological effects were observed on the test subjects. The study was
found “ACCEPTABLE,” and Salicylic Acid was classified as TOXICITY
CATEGORY IV for this route of exposure when used as a seed treatment.

Primary Eye Irritation – Rabbit (OCSPP Guideline 870.2400; MRID No.
47206706):  A primary eye irritation study on rabbits demonstrated
Salicylic Acid to be moderately irritating to the eye; however, all
iritis and conjunctivitis cleared after 24 hours. The study was found
“ACCEPTABLE,” and Salicylic Acid was classified as TOXICITY CATEGORY
III for this route of exposure when used as a seed treatment.

Primary Dermal Irritation – Rabbit (OCSPP Guideline 870.2500; MRID No.
47206709):  A skin irritation study on rabbits demonstrated that
Salicylic Acid was not irritating to the skin. The findings are
consistent with the other dermal studies and confirm that Salicylic Acid
is not toxic through this route of exposure. The study was found
“ACCEPTABLE,” and Salicylic Acid was classified as TOXICITY CATEGORY
IV for this route of exposure when used as a seed treatment.

Skin Sensitization – Guinea Pig (OCSPP Guideline 870.2600; MRID No.
47206708):  Data indicate Salicylic Acid is not a dermal sensitizer. Any
reported incidents, however, may cause this position to be reconsidered.

Subchronic Testing (OCSPP Guidelines 870.3100, 870.3250, and 870.3465;
MRID Nos. 48225204 and 48225206):  In accordance with footnotes six,
seven and eight in the Biochemical Pesticides Human Health Assessment
Data Requirements table in 40 CFR § 158.2050, subchronic oral,
subchronic dermal and subchronic inhalation testing were not required in
this case because of a lack of exposure. Nonetheless, two subchronic
oral tests, two subchronic dermal tests and one subchronic inhalation
study were submitted. These studies are considered “SUPPLEMENTAL.”
One subchronic oral test used methyl salicylate as its test substance;
and the other study used acetylsalicylic acid as its test substance.
Both test substances readily metabolize into Salicylic Acid and are
considered applicable to this risk assessment. The subchronic oral
toxicity studies confirm that Salicylic Acid is not subchronically toxic
through the oral route of exposure. With regard to subchronic dermal
tests on Salicylic Acid, two studies on a Salicylic Acid test substance
showed no systemic toxicity and indicated no subchronic toxicity through
a dermal route of exposure. With regard to subchronic inhalation
toxicity, a subchronic inhalation test on methyl salicylate was
submitted in lieu of a study on Salicylic Acid. The supplemental
information suggests that there is no subchronic toxicity for Salicylic
Acid through an inhalation route of exposure. All this supplemental
information is secondary to the determination that there is virtually no
exposure to this active ingredient when it is used as a seed treatment.

Developmental Toxicity (OCSPP Guideline 870.3700; MRID No. 48225205):
Developmental toxicity data are conditionally required if significant
exposure to female humans is expected from the proposed product’s use
under widespread and commonly recognized practice. Significant exposure
to females is unlikely: Salicylic Acid is to be applied in a closed
system that precludes significant exposure. Exposure to
handlers/applicators is negligible as applications are seasonal, and EP
labels require appropriate PPE. Additionally, exposure during planting
is unlikely because planting is done mechanically, users are required to
wear PPE and Salicylic Acid biodegrades rapidly in the environment,
further mitigating exposure (HSDB, 2011). Although risk to humans is
anticipated to be negligible because significant human exposure is not
anticipated, “SUPPLEMENTAL” developmental toxicity studies were
submitted from the open scientific literature with MRID No. 48225205.
Each study suggested that the risk for developmental toxicity was
negligible. The maternal no observed effect level (NOEL) in the study
was 75 mg/kg Salicylic Acid, and the lowest observed effect level (LOEL)
was 150 mg/kg. These findings suggest negligible developmental toxicity
relative to any potential exposures to Salicylic Acid when used as a
seed treatment

Mutagenicity Testing (OCSPP Guidelines 870.5100, 870.5300, and 870.5375;
MRID No. 48225207):  Mutagenicity data are conditionally required to
support nonfood uses if the use is likely to result in significant human
exposure or if the active ingredient or its metabolites are structurally
related to a known mutagen or belong to any chemical class of compounds
containing a known mutagen. Significant exposure to humans is unlikely
based on Salicylic Acid’s use pattern as a seed treatment. Significant
exposure to handlers/applicators is unlikely as EP labels require PPE to
further mitigate exposure. Finally, Salicylic Acid biodegrades rapidly
in the environment, further mitigating exposure (HSDB, 2008). Although
risk to humans has been determined to be negligible because significant
human exposure is not anticipated, “SUPPLEMENTAL” mutagenicity data
were submitted. Results were negative in a modified Ames mutagenicity
assay with and without metabolic activation at 1, 10, and 100 μg
SA/plate using Salmonella typhimurium strains TA1535, TA1537, TA1538,
and TA1536 (HSDB, 2011). Furthermore, a study from the open scientific
literature was provided in which Salicylic Acid and other Salicylic Acid
derivatives were tested for their capacity to induce sister chromatid
exchange (SCE) and chromosomal aberrations (CA) in the bone marrow of
Swiss albino male mice. There was no increased incidence of SCE in the
assay, indicating that Salicylic Acid is not anticipated to be
mutagenic. The information submitted was determined to be adequate to
support this seed treatment use.

b.	Acute Toxicity – Tier II and Tier III (40 CFR § 158.2050)

No Tier II and Tier III studies were required, based on a lack of acute
toxicity in the Tier I studies and a lack of exposure relative to
Salicylic Acid’s pre-planting use pattern as a seed treatment.

			c.   Effects on the Endocrine System

As required under Federal Food, Drug, and Cosmetic Act (FFDCA) section
408(p), EPA has developed the Endocrine Disruptor Screening Program
(EDSP) to determine whether certain substances (including pesticide
active and other ingredients) may have an effect in humans or wildlife
similar to an effect produced by a “naturally occurring estrogen, or
other such endocrine effects as the Administrator may designate.” The
EDSP employs a two-tiered approach to making the statutorily required
determinations. Tier 1 consists of a battery of 11 screening assays to
identify the potential of a chemical substance to interact with the
estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals
that go through Tier 1 screening and are found to have the potential to
interact with E, A, or T hormonal systems will proceed to the next stage
of the EDSP where EPA will determine which, if any, of the Tier 2 tests
are necessary based on the available data. Tier 2 testing is designed to
identify any adverse endocrine-related effects caused by the substance,
and establish a quantitative relationship between the dose and the E, A,
or T effect.

Between October 2009 and February 2010, EPA issued test orders/data
call-ins for the first group of 67 chemicals, which contains 58
pesticide active ingredients and 9 inert ingredients. This list of
chemicals was selected based on the potential for human exposure through
pathways such as food and water, residential activity, and certain
post-application agricultural scenarios. This list should not be
construed as a list of known or likely endocrine disruptors.

Salicylic Acid is not among the group of 58 pesticide active ingredients
on the initial list to be screened under the EDSP. Under FFDCA section
408(p), EPA must screen all pesticide chemicals. Accordingly, EPA
anticipates issuing future EDSP orders/data call-ins for all pesticide
active ingredients. For further information on the status of the EDSP,
the policies and procedures, the list of 67 chemicals, the test
guidelines and the Tier 1 screening battery, please visit our website:
HYPERLINK "http://www.epa.gov/endo/"  http://www.epa.gov/endo/ .

		2.   Dose Response Assessment

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

		3.   Dietary Exposure and Risk Characterization

Salicylic Acid is intended for use as a pre-planting seed treatment, and
is considered to be a nonfood use. Exposure to residues of Salicylic
Acid is not expected. Data indicate that Salicylic Acid is not taken up
into the plant systemically, and that endogenous applications biodegrade
rapidly, long before a plant might fruit. Even in the incidental event
of exposure to residues, no dietary risks are anticipated. Acute,
subchronic, and teratogenicity studies support Salicylic Acid’s
nontoxic profile. It is already present in the human diet – in all
fruits and vegetables – without any known detrimental effect.
Furthermore, there is no information in the public literature suggesting
any health issues to either animals or plants relative to this compound.
In sum, no dietary exposure is expected; and any potential dietary
exposures would not be expected to pose any quantifiable risk, due to
Salicylic Acid’s nontoxic profile.

	4.   Drinking Water Exposure Risk Characterization

No residues are expected in drinking water as a result of the use of
Salicylic Acid as a seed treatment. Applications of Salicylic Acid are
to be made directly to seeds in a closed system. Seeds are then planted
directly into the soil. Because these seeds are contained in the soil,
run-off due to watering seems unlikely. Even in the incidental event of
exposure to residues, no dietary risks are anticipated. Acute,
subchronic, and teratogenicity studies support Salicylic Acid’s
nontoxic profile.  It is already present in the human diet – in all
fruits and vegetables – without any known detrimental effect.
Furthermore, there is no information in the public literature suggesting
any health issues to either animals or plants relative to this compound.
Negligible residues might migrate through the soil after a rain event or
watering but would not be expected to reach surface water or percolate
through the soil to ground water given the rapid biodegradation of
Salicylic Acid and the rapid metabolization of Salicylic Acid by soil
microbes. Therefore, the Agency concludes that the use of Salicylic Acid
as a pre-planting seed treatment is not expected to result in any
significant drinking water exposure. Altogether, drinking water exposure
is not expected to pose any quantifiable risk, due to both a lack of
residues and the nontoxicity of Salicylic Acid.

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

Dietary exposure to humans, including infants and children, is not
anticipated with regard to the pesticidal use of Salicylic Acid as a
seed treatment. The application is considered a nonfood use because the
residue is not expressed systemically into the plant; and the active
ingredient is expected to biodegrade soon after planting. In the event
that there are any residues, acute toxicity studies indicate that
Salicylic Acid has negligible toxicity. It is ubiquitous in nature and
present in all edible plants, and there is no history of toxicological
incident involving its consumption. While no dietary exposures are
expected, the Agency has determined there is a reasonable certainty of
no harm to the general U.S. population, including infants and children,
from exposure to this active ingredient.

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

Occupational exposure to Salicylic Acid is anticipated to be minimal
when Salicylic Acid is used as a seed treatment. It is expected to be de
minimis for residential, school, or day care areas. In the event of
incidental exposure, health risks to humans, including infants and
children, are considered negligible, given Salicylic Acid’s nontoxic
profile.

			a. 	Occupational Exposure and Risk Characterization

An occupational exposure assessment was not conducted for Salicylic
Acid. Based on the proposed use pattern and toxicity data available to
the Agency, there are no exposure scenarios likely to result in
unreasonable risk to humans. With regard to risks to incidental
exposure, no relevant toxicological endpoints were identified.

The rationale follows: Seeds are treated in a closed system; and then
seeds are incorporated directly into the soil. Pre-planting seed
treatments are infrequent and seasonal. Workers treating seeds and
workers planting treated seed will have PPE. Finally, given the rapid
rate of biodegradation, incidental exposures related to reentry into a
newly planted area are anticipated to be negligible (U.S. EPA. 2011b.).
But even in the event of occupational exposure, any health risks
associated with regular exposure seem unlikely. People regularly consume
Salicylic Acid in their fruits and vegetables, and apply it topically in
many over-the-counter antiseptics, antibiotics and cleaners. With regard
to these regular exposures, there is no history of detrimental effects.
Moreover, all acute, subchronic, and developmental toxicity data
submitted to support the registration applications for Salicylic Acid
confirm its lack of toxicity through all routes of exposure.

			b. 	Residential, School, and Day Care Exposure and Risk
Characterization

A residential, school and day care exposure assessment was not conducted
for Salicylic Acid. Products containing Salicylic Acid will be used in
an agricultural setting. Based on the use pattern, residential, school
and day care exposures are unlikely. In the remote event of incidental
exposure to residues, the active ingredient has a nontoxic profile for
all routes of exposure and a long history of consumption without
incident. 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. No
exposures are anticipated in non-occupational environments. Seeds
treated with Salicylic Acid are incorporated into the soil directly. It
has been established that Salicylic Acid biodegrades rapidly in soil;
and the residues are not taken up into the plant systemically (HDSB,
2008). (Indeed, no residues are expected to be present in the
seedlings.) Given a lack of any significant non-occupational exposure, a
lack of concern regarding its naturally occurring background levels, and
a lack of any acute toxicological endpoints for Salicylic Acid, the
aggregate exposure scenario presents no significant concerns for risk.

		8.   Cumulative Effects

Pursuant to FFDCA section 408(b)(2)(D)(v), EPA has considered available
information concerning the cumulative effects of Salicylic Acid
residues and other substances that have a common mechanism of toxicity.
These considerations include the potential for cumulative effects on
infants and children of Salicylic Acid residues and other substances
with a common mechanism of toxicity. Because Salicylic Acid has a long
history of dietary consumption without incident, and because no
toxicological endpoints have been established, the Agency concludes that
Salicylic Acid does not share a common mechanism of toxicity, and that
there are no potential cumulative effects arising from incidental
exposures to Salicylic Acid residues in or on food commodities.

		9.  	Risk Characterization

The Agency considered human exposure to Salicylic Acid in light of the
standard for registration in the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) and the relevant safety factors in FFDCA. 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 Salicylic Acid 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)

Adequate nontarget toxicology data/information are available to support
registration of Salicylic Acid. All nontarget toxicology data
requirements for Salicylic Acid have been satisfied. There are no
concerns for any nontarget organisms when Salicylic Acid is applied as a
seed treatment. No toxic endpoints have been identified for nontarget
mammals, nontarget birds, nontarget aquatic organisms and nontarget
insects.

TABLE 4.  Nontarget Organism Toxicity Requirements for Salicylic Acid
Technical (40 CFR § 158.2060)

Study/OCSPP Guideline No.

	Results	Toxicity Category/Description	MRID No.

Avian acute oral toxicity

Colinus virginianus

(850.2100)

LD50 = 494 mg/kg

(95% confidence interval = 396-614 mg/kg)

Moderately toxic

47206704

Avian dietary toxicity

Colinus virginianus and Anas platyrhynchos

(850.2200)

LC50 > 5,000 ppm

NOAEL = 2,500 ppm

(for both species)	Practically nontoxic	47206702

47229501

Aquatic invertebrate acute toxicity

(Daphnia magna)

(850.1010)	48-hour EC50 = 184.88 mg/L

(95% confidence interval = 182.1-187.7 mg/L)	Practically nontoxic
47206703

Freshwater fish LC50

(Oncorhynchus mykiss)

(850.1075)	96-hour LC50 = 134.8 mg/L

(95% confidence interval = 125-145 mg/L)	Practically nontoxic	47206705

Nontarget plant studies-seedling emergence

(850.4100)	 Based on the proposed use pattern (SA is directly applied to
target seeds only prior to planting) and that SA biodegrades rapidly in
the environment, seedling emergence in nontarget plants is not
anticipated to be adversely impacted.

48225210

Nontarget plant studies-vegetative vigor

(850.4150)	The proposed use of SA a seed treatment is not expected to
result in adverse effects to vegetative vigor, as the active ingredient
will not be used on seedlings or mature plants. SA is directly applied
to target seeds only prior to planting. Additionally, the active
ingredient biodegrades quickly in the environment, which further
precludes exposure to nontarget plants.

48225211

Nontarget insect testing (Apis mellifera)

(880.4350)	96-hour acute contact LD50 > 100 µg/bee	Practically nontoxic
48225212

Avian Testing (OCSPP Guidelines 850.2100 and 850.2200; MRID Nos.
47206704 and 47206702):

No avian toxicity is expected with regard to the pesticidal use of
Salicylic Acid. Two acute oral toxicity studies were found
“ACCEPTABLE.” The studies established the following thresholds: LD50
= 494 mg/kg, an LC50 > 5,000 ppm, and an NOAEL = 2,500 ppm. Each
threshold is far in excess of any anticipated exposure; and no
toxicological endpoints were established. The data indicate that
Salicylic Acid is practically nontoxic to birds.

Aquatic Organism Testing (OCSPP Guidelines 850.1010 and 850.1075; MRID
Nos. 47206703 and 47206705):  No risks are expected with regard to the
exposure of aquatic organisms to Salicylic Acid. Aquatic exposure is
unlikely because seed treatments are conducted in closed systems,
treated seeds are incorporated directly into soil, and Salicylic Acid is
known to rapidly biodegrade in soil. In the event of any aquatic
exposures, the data indicate that Salicylic Acid is practically nontoxic
to aquatic organisms. A nontarget aquatic invertebrate study and a
freshwater fish study were found “ACCEPTABLE.” The studies
established the following thresholds: LC50 = 134.8 mg/L and an EC50 >
184.88 mg/L. Each threshold is far in excess of any anticipated
exposure; and no toxicological endpoints were established. The data
indicate that Salicylic Acid is practically nontoxic to aquatic
nontarget organisms.

Nontarget Plant Testing (OCSPP Guidelines 850.4100 and 850.4150; MRID
Nos. 4825210 and 4825211 ):  Two nontarget plant studies were conducted.
In one study, a solution containing 0.039% Salicylic Acid (the maximum
dose for the proposed EP) was tested for effects on seedling emergence
in ten species of plants for 21 days, during which time seedling
emergence and plant height were observed. Based on the findings, there
were no attributable effects to seedling emergence on nontarget plants.
In the second study, a solution containing 0.039% Salicylic Acid (the
maximum dose for the proposed EP) was tested for effects on vegetative
vigor in ten species of plants for 21 days, during which time plant
survival, growth and condition were observed. There were no reported
adverse effects (25% or greater) in nine of the ten species tested when
compared to controls. A statistically significant (p<0.05) reduction of
25% was reported for the mean dry weight of ryegrass. Phytotoxic effects
such as chlorosis, insect damage, leaf curl, necrosis and wilt were
noted on some plants but were infrequent, generally not severe and
present in both treatment and control groups. Although some phytotoxic
effects were noted in this study, the proposed use of Salicylic Acid as
a seed treatment is not expected to result in adverse effects to
vegetative vigor, as the active ingredient will not be used on seedlings
or mature plants. Moreover, the active ingredient biodegrades quickly in
the environment, which further precludes exposure to nontarget plants.
No toxic effects are anticipated to nontarget plants when Salicylic Acid
is applied as a seed treatment.

Nontarget Insect Testing (OCSPP Guidelines 880.4350; MRID No. 48225212):
 An acute contact toxicity test was conducted to evaluate the toxicity
to the honey bee from exposure to Salycylic Acid. Groups of young adult
honey bees (Apis mellifera) were dosed topically with the active
ingredient at 100, 50, 25, 12.5 and 6.25 µg/bee. Bees were observed for
mortality and other toxic effects twice within the four hours
post-treatment and at 24, 48, 72 and 96 hours. Based on the observed
effects, the NOEC was determined to be 25 µg/bee and the 96-hour acute
contact LD50 > 100 µg/bee. No such exposures are anticipated for
nontarget insects. Nevertheless, the findings indicate that Salicylic
Acid is practically nontoxic to nontarget insects.

2.  	Environmental Fate and Ground Water Data

Environmental fate and groundwater data are not required at this time
because the results of the nontarget organism toxicity assessment (Tier
I data requirements) did not trigger these Tier II data requirements.

3.  	Ecological Exposure and Risk Characterization

No significant exposure to nontarget organisms is anticipated when
Salicylic Acid is applied as a seed treatment. Treatment occurs in a
closed environment; and treated seeds are incorporated directly into the
soil. Additionally, the active ingredient biodegrades rapidly in the
environment, further precluding exposure. Regardless, the risk to
nontargets is minimal. Salicylic Acid is practically nontoxic to fish,
birds, mammals, aquatic invertebrates and insects. While some
phytotoxicity was observed in one species of plant (of the ten tested),
the effects were minimal and not attributable to Salicylic Acid.

The Agency was able to quantify the risk to terrestrial nontarget
organisms through modeling. Using the Agency’s Terrestrial Residue
Exposure model (T-REX) version 1.4.1, risk quotients (RQs) were
calculated to assess potential risk to birds. The risk quotients that
were conservatively calculated using the hazard data and estimated
dietary exposure (calculated using T-REX) were determined to be
significantly less than the Agency’s level of concern (LOC) of 0.1 for
threatened and endangered avian species. This information is summarized
in Table 5 below. Anticipated exposures are unlikely to result in
unreasonable risk to avian species when Salicylic Acid is used as a seed
treatment.

TABLE 5.  Determination of  Avian Risk Quotients (RQs) for Salicylic
Acid Technical

Species	LD50/NOEL	Acute RQ

([mg/kg bw-day]/LD50) 	Crops

Colinus

virginianus

LD50 = 494 mg/kg

(95% confidence

interval =

396-614 mg/kg)

0.03 (for all crops)	Barley, beans, dried beans, lima beans, snap beans,
canola, corn, cotton, oats, onion, blackeyed peas, pea, lupine, grain
lupine, field peas, peanuts, rice, rye, safflower, sorghum, soybeans,
soybeans (edible), sugar beets, triticale, wheat.

4.   Threatened and Endangered Species Assessment

The Agency has not conducted a risk assessment that supports a complete
endangered species determination. The ecological risk assessment planned
during registration review will allow the Agency to determine whether
Salicylic Acid’s use has “no effect” or “may effect” federally
listed threatened or endangered species (listed species) or their
designated critical habitats. When an assessment concludes that a
pesticide’s use “may affect” a listed species or its designated
critical habitat, the Agency will consult with the U.S. Fish and
Wildlife Service and/or National Marine Fisheries Services (the
Services) as appropriate.

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 Salicylic Acid, compared to the
general population. Please comment if you are aware of any
sub-populations that may have atypical, unusually high exposure compared
to the general population.

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

	A.  Determination of Eligibility

 tc "A.  Determination of Eligibility " \l 2

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

The four criteria of the Eligibility Determination for Pesticidal Active
Ingredients are satisfied by the science assessments supporting products
containing Salicylic Acid. 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 Salicylic Acid is eligible for registration for the
labeled uses.

	B.  Regulatory Decision

On October 1, 2009, the EPA announced a new policy to provide a more
meaningful opportunity for the public to participate in major
registration decisions before they occur. According to this 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 uses; first outdoor
uses; first residential uses; or any other registration actions for
which EPA believes there may be significant public interest.
Accordingly, this pesticide is subject to a 30-day comment period as a
new active ingredient with outdoor uses.

At this time, EPA believes, the data submitted fulfill the requirements
of registration for products containing Salicylic Acid for use as a seed
treatment and SAR inducer. Acute toxicity data for Salicylic Acid
demonstrate that it is toxicity category III and IV for all routes of
exposure. (No toxicological endpoints were established.) Data confirm
that Salicylic Acid does not demonstrate subchronic or developmental
toxicity, and it is not mutagenic or genotoxic. EPA has no concerns for
any nontarget organisms exposed to Salicylic Acid in accordance with its
approved uses. EPA has not identified any toxic endpoints for nontarget
mammals, birds, plants, aquatic, or soil organisms. Nor are there any
anticipated concerns for any threatened and endangered species.  Given
the nontoxic character of Salicylic Acid and because all applicable data
requirements have been fulfilled, EPA supports its registration under
FIFRA section 3(c)(5).

	C.  Labeling

Before releasing pesticide products containing Salicylic Acid for
shipment, the applicant is required to provide appropriate labels.

VII.  ACTIONS REQUIRED OF THE REGISTRANT

The Agency evaluated the data submitted in connection with the initial
registration of Salicylic Acid 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 § 158.2050(e).

VIII.  GLOSSARY OF ACRONYMS AND ABBREVIATIONS

ADI	average daily intake

BPB	Biochemical Pesticides Branch

BRAD	Biopesticides Registration Action Document

CA	chromosomal aberrations

CAS	Chemical Abstracts Service

CFR	Code of Federal Regulations

EDSP	Endocrine Disruptor Screening Program

EP	End-use Product

EPA	United States Environmental Protection Agency (Agency)

FDA	United States Food and Drug Administration

FFDCA	Federal Food, Drug, and Cosmetic Act

FIFRA	Federal Insecticide, Fungicide, and Rodenticide Act

FR	Federal Register

g 	gram

g/mL	gram per milliliter

Hg	mercury

HSDB	Hazardous Substances Data Bank

	LC50		median lethal concentration. A statistically derived
concentration of a

		substance that can be expected to cause death in 50% of test animals.
It is

		usually expressed as the weight of substance per weight or volume of
water,

		air, or feed (e.g., mg/L, mg/kg, or ppm).

LD50	median lethal dose. A statistically derived single dose that can be
expected

	to cause death in 50% of the test animals when administered by the
route

	indicated (oral, dermal, or inhalation). It is expressed as a weight of

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

LOC	level of concern

LOEL	lowest observed effect level

μg	microgram

μm	micrometer

MRID No.	Master Record Identification Number

mg/kg	milligram per kilogram

mg/L	milligram per liter

mg/ml	milligram per milliliter

ml	milliliter

mm	millimeter

MP	Manufacturing-use Product

nm	nanometer

NOAEL	no observed adverse effect level

NOEC	no observed effect concentration

NOEL	no observed effect level

OCSPP	Office of Chemical Safety and Pollution Prevention

OPP	Office of Pesticide Programs

Pa	pascal

PC Code	Pesticide Chemical Code

ppb	parts per billion

PPE 	personal protective equipment

ppm	parts per million

RQ	risk quotient

SA	Salicylic Acid

SAR	Systemic Acquired Resistance

SCE	sister chromatid exchange

IX.  BIBLIOGRAPHY STUDIES SUBMITTED IN SUPPORT OF THESE

  REGISTRATIONS

	A.  Studies Submitted in Support of Salicylic Acid

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	B. 	EPA Risk Assessment Memoranda

U.S. EPA. 2011a. Gonzales, Angela L. Science Review in Support of
Salicylic Acid Technical, Containing 98.7% Salicylic Acid as Its Active
Ingredient.  Memorandum dated 12/8/2011.

U.S. EPA. 2011b. Gonzales, Angela L. Science Review in Support of
Salicylic Acid Technical, Containing 98.7% Salicylic Acid as Its Active
Ingredient.  Memorandum dated 06/16/2011.

	C.  References

Hazardous Substances Data Bank (HSDB). 2008. “Salicylic Acid”. U.S.
Department of Health

	and Human Services, National Library of Medicine. March 31, 2011.

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U.S. EPA  2008. Terrestrial Residue Exposure Model (T-REX) Version
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		EFED/OPP/USEPA.

Salicylic Acid	           																		Page   PAGE  14

Biopesticides Registration Action Document

 PAGE


[Federal Register Volume 79, Number 249 (Tuesday, December 30, 2014)]
[Notices]
[Pages 78461-78463]
[FR Doc No: 2014-30532]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2014-0002; Internal Agency Docket No. FEMA-B-1460]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency Management Agency (FEMA) for
each community, is appropriate because of new scientific or technical
data. The FIRM, and where applicable, portions of the FIS report, have
been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR), in accordance with Title
44, Part 65 of the Code of Federal Regulations (44 CFR part 65). The
LOMR will be used by insurance agents and others to calculate
appropriate flood insurance premium rates for new buildings and the
contents of those buildings. For rating purposes, the currently
effective community number is shown in the table below and must be used
for all new policies and renewals.

DATES: These flood hazard determinations will become effective on the
dates listed in the table below and revise the FIRM panels and FIS
report in effect prior to this determination for the listed
communities.
    From the date of the second publication of notification of these
changes in a newspaper of local circulation, any person has 90 days in
which to request through the community that the Deputy Associate
Administrator for Mitigation reconsider the changes. The flood hazard
determination information may be changed during the 90-day period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at www.msc.fema.gov for comparison.
    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood
hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    The FIRM and FIS report are the basis of the floodplain management
measures that the community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the National Flood Insurance Program (NFIP).
    These flood hazard determinations, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own or pursuant to policies established by
other Federal, State, or regional entities. The flood hazard
determinations are in accordance with 44 CFR 65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at www.msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: December 11, 2014.
Roy E. Wright,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         Chief executive                         Online location of
        State and county           Location and case       officer of         Community map        letter of map        Effective date of     Community
                                          No.               community          repository             revision             modification          No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alabama
    Baldwin.....................  City of Gulf Shores  The Honorable       Community           http://                Feb. 23, 2015........       015005
                                   (14-04-6192P).       Robert Craft,       Development         www.msc.fema.gov/
                                                        Mayor, City of      Department, 1905    lomc.
                                                        Gulf Shores, P.O.   West 1st Street,
                                                        Box 299, Gulf       Gulf Shores, AL
                                                        Shores, AL 36547.   36547.
    Colbert.....................  City of Muscle       The Honorable       City Hall, 2010     http://                Feb. 2, 2015.........       010047
                                   Shoals (14-04-       David Bradford,     East Avalon         www.msc.fema.gov/
                                   8204P).              Mayor, City of      Avenue, Muscle      lomc.
                                                        Muscle Shoals,      Shoals, AL 35661.
                                                        P.O. Box 2624,
                                                        Muscle Shoals, AL
                                                        35662.
    Madison.....................  Unincorporated       The Honorable Dale  Madison County      http://                Feb. 19, 2015........       010151
                                   areas of Madison     W. Strong,          Public Works        www.msc.fema.gov/
                                   County (14-04-       Chairman, Madison   Department, 266-C   lomc.
                                   7485P).              County Board of     Shields Road,
                                                        Commissioners,      Huntsville, AL
                                                        100 Northside       35811.
                                                        Square,
                                                        Huntsville, AL
                                                        35801.
Arizona:
    Maricopa....................  City of El Mirage    The Honorable Lana  City Hall, 14405    http://                Feb. 27, 2015........       040041
                                   (14-09-2966P).       Mook, Mayor, City   North Palm          www.msc.fema.gov/
                                                        of El Mirage,       Street, El          lomc.
                                                        12145 Northwest     Mirage, AZ 85335.
                                                        Grand Avenue, El
                                                        Mirage, AZ 85335.
    Maricopa....................  Unincorporated       The Honorable       Maricopa County     http://                Feb. 27, 2015........       040037
                                   areas of Maricopa    Denny Barney,       Flood Control       www.msc.fema.gov/
                                   County (14-09-       Chairman,           District, 2801      lomc.
                                   2966P).              Maricopa County     West Durango
                                                        Board of            Street, Phoenix,
                                                        Commissioners,      AZ 85009.
                                                        301 West
                                                        Jefferson, 10th
                                                        Floor, Phoenix,
                                                        AZ 85003.
    Maricopa....................  Unincorporated       The Honorable       Maricopa County     http://                Feb. 27, 2015........       040037
                                   areas of Maricopa    Denny Barney,       Flood Control       www.msc.fema.gov/
                                   County (14-09-       Chairman,           District, 2801      lomc.
                                   2190P).              Maricopa County     West Durango
                                                        Board of            Street, Phoenix,
                                                        Commissioners,      AZ 85009.
                                                        301 West
                                                        Jefferson, 10th
                                                        Floor, Phoenix,
                                                        AZ 85003.
California:
    Los Angeles.................  Unincorporated       The Honorable Don   Los Angeles County  http://                Mar. 2, 2015.........       065043
                                   areas of Los         Knabe, Chairman,    Department of       www.msc.fema.gov/
                                   Angeles County (14-  Los Angeles         Public Works, 900   lomc.
                                   09-4094P).           County Board of     South Fremont
                                                        Supervisors, 500    Avenue, Alhambra,
                                                        West Temple         CA 91803.
                                                        Street, Los
                                                        Angeles, CA 90012.
    Santa Clara.................  City of Morgan Hill  The Honorable       Public Works        http://                Mar. 2, 2015.........       060346
                                   (14-09-3877P).       Steve Tate,         Department,         www.msc.fema.gov/
                                                        Mayor, City of      Engineering         lomc.
                                                        Morgan Hill,        Division, 17575
                                                        17575 Peak          Peak Avenue,
                                                        Avenue, Morgan      Morgan Hill, CA
                                                        Hill, CA 95037.     95037.
Florida:
    Bay.........................  Unincorporated       The Honorable Guy   Bay County          http://                Mar. 9, 2015.........       120004
                                   areas of Bay         M. Tunnell,         Planning and        www.msc.fema.gov/
                                   County (14-04-       Chairman, Bay       Zoning              lomc.
                                   8612P).              County Board of     Department, 808
                                                        Commissioners,      West 11th Street,
                                                        808 West 11th       Panama City, FL
                                                        Street, Panama      32401.
                                                        City, FL 32401.
    Duval.......................  City of              The Honorable       Development         http://                Mar. 2, 2015.........       120077
                                   Jacksonville (14-    Alvin Brown,        Services            www.msc.fema.gov/
                                   04-6432P).           Mayor, City of      Department, 214     lomc.
                                                        Jacksonville, 117   Hogan Street
                                                        West Duval          North, Suite
                                                        Street, Suite       2100,
                                                        400,                Jacksonville, FL
                                                        Jacksonville, FL    32202.
                                                        32202.
    Monroe......................  City of Key West     The Honorable       Planning            http://                Feb. 26, 2015........       120168
                                   (14-04-7227P).       Craig Cates,        Department, 3140    www.msc.fema.gov/
                                                        Mayor, City of      Flagler Avenue,     lomc.
                                                        Key West, 3126      Key West, FL
                                                        Flagler Avenue,     33040.
                                                        Key West, FL
                                                        33040.
    Orange......................  City of Orlando (14- The Honorable       Permitting          http://                Mar. 6, 2015.........       120186
                                   04-5319P).           Buddy Dyer,         Services            www.msc.fema.gov/
                                                        Mayor, City of      Division, 400       lomc.
                                                        Orlando, P.O. Box   South Orange
                                                        4990, Orlando, FL   Avenue, Orlando,
                                                        32802.              FL 32801.
    Orange......................  Unincorporated       The Honorable       Orange County       http://                Mar. 6, 2015.........       120179
                                   areas of Orange      Teresa Jacobs,      Stormwater          www.msc.fema.gov/
                                   County (14-04-       Mayor, Orange       Management          lomc.
                                   5319P).              County, 201 South   Department, 4200
                                                        Rosalind Avenue,    South John Young
                                                        5th Floor,          Parkway, Orlando,
                                                        Orlando, FL 32801.  FL 32839.
    Orange......................  Unincorporated       The Honorable       Orange County       http://                Mar. 6, 2015.........       120179
                                   areas of Orange      Teresa Jacobs,      Stormwater          www.msc.fema.gov/
                                   County (14-04-       Mayor, Orange       Management          lomc.
                                   4367P).              County, 201 South   Department, 4200
                                                        Rosalind Avenue,    South John Young
                                                        5th Floor,          Parkway, Orlando,
                                                        Orlando, FL 32801.  FL 32839.

Georgia:
    Columbia....................  City of Grovetown    The Honorable       Water Department,   http://                Mar. 2, 2015.........       130265
                                   (14-04-4634P).       George W. James,    103 Old             www.msc.fema.gov/
                                                        III, Mayor, City    Wrightsboro Road,   lomc.
                                                        of Grovetown, 103   Grovetown, GA
                                                        Old Wrightsboro     30813.
                                                        Road, Grovetown,
                                                        GA 30813.
    Columbia....................  Unincorporated       The Honorable Ron   Columbia County     http://                Mar. 2, 2015.........       130059
                                   areas of Columbia    C. Cross,           Planning Services   www.msc.fema.gov/
                                   County (14-04-       Chairman,           Division, 603       lomc.
                                   4634P).              Columbia County     Ronald Reagan
                                                        Board of            Drive, Building
                                                        Commissioners,      B, 1st Floor,
                                                        P.O. Box 498,       Evans, GA 30809.
                                                        Evans, GA 30809.
Hawaii: Maui....................  Maui County (14-09-  The Honorable Alan  Maui County         http://                Mar. 2, 2015.........       150003
                                   2279P).              M. Arakawa,         Planning            www.msc.fema.gov/
                                                        Mayor, Maui         Department, 250     lomc.
                                                        County, 200 South   South High
                                                        High Street, 9th    Street, 2nd
                                                        Floor, Wailuku,     Floor, Wailuku,
                                                        HI 96793.           HI 96793.
Mississippi:
    Lafayette...................  City of Oxford (14-  The Honorable       City Hall, 107      http://                Mar. 2, 2015.........       280094
                                   04-4705P).           George Patterson,   Courthouse          www.msc.fema.gov/
                                                        Mayor, City of      Square, Oxford,     lomc.
                                                        Oxford, 107         MS 38655.
                                                        Courthouse
                                                        Square, Oxford,
                                                        MS 38655.
    Lafayette...................  Unincorporated       The Honorable Jeff  Lafayette County    http://                Mar. 2, 2015.........       280093
                                   areas of Lafayette   Busby, President,   Emergency           www.msc.fema.gov/
                                   County (14-04-       Lafayette County    Management          lomc.
                                   4705P).              Board of            Department, 300
                                                        Supervisors, 300    North Lamar
                                                        North Lamar         Boulevard,
                                                        Boulevard,          Oxford, MS 38655.
                                                        Oxford, MS 38655.
Nevada:
    Clark.......................  City of Boulder      The Honorable       Engineering         http://                Feb. 19, 2015........       320004
                                   City (14-09-1535P).  Roger Tobler,       Department, 401     www.msc.fema.gov/
                                                        Mayor, City of      California          lomc.
                                                        Boulder City, 401   Avenue, Boulder
                                                        California          City, NV 89005.
                                                        Avenue, Boulder
                                                        City, NV 89005.
    Clark.......................  Unincorporated       The Honorable       Clark County        http://                Feb. 19, 2015........       320003
                                   areas of Clark       Steve Sisolak,      Public Works        www.msc.fema.gov/
                                   County (14-09-       Chairman, Clark     Department, 500     lomc.
                                   2584P).              County Board of     Grand Central
                                                        Commissioners,      Parkway, Las
                                                        500 South Grand     Vegas, NV 89155.
                                                        Central Parkway,
                                                        Las Vegas, NV
                                                        89155.
North Carolina:
    Brunswick...................  Town of St. James    The Honorable       Town Hall, 4140 A   http://                Feb. 27, 2015........       370530
                                   (13-04-4667P).       Rebecca Dus,        Southport-Supply    www.msc.fema.gov/
                                                        Mayor, Town of      Road, St. James,    lomc.
                                                        St. James, 4140 A   NC 28461.
                                                        Southport-Supply
                                                        Road, St. James,
                                                        NC 28461.
    Brunswick...................  Unincorporated       The Honorable Phil  Brunswick County    http://                Feb. 27, 2015........       370295
                                   areas of Brunswick   Norris, Chairman,   Building            www.msc.fema.gov/
                                   County (13-04-       Brunswick County    Inspections         lomc.
                                   4667P).              Board of            Department,
                                                        Commissioners,      Building I, 75
                                                        P.O. Box 249,       Courthouse Drive,
                                                        Bolivia, NC 28422.  Northeast,
                                                                            Bolivia, NC 28422.
    Mecklenburg.................  City of Charlotte    The Honorable       Mecklenburg County  http://                Feb. 19, 2015........       370159
                                   (14-04-8637P).       Daniel              Storm Water         www.msc.fema.gov/
                                                        Clodfelter,         Services            lomc.
                                                        Mayor, City of      Division, 700
                                                        Charlotte, 600      North Tryon
                                                        East 4th Street,    Street,
                                                        Charlotte, NC       Charlotte, NC
                                                        28202.              28202.
Utah: Washington................  Town of Springdale   The Honorable Stan  Planning and        http://                Feb. 26, 2015........       490179
                                   (14-08-0976P).       Smith, Mayor,       Zoning              www.msc.fema.gov/
                                                        Town of             Department, 118     lomc.
                                                        Springdale, 118     Lion Boulevard,
                                                        Lion Boulevard,     Springdale, UT
                                                        Springdale, UT      84767.
                                                        84767.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2014-30532 Filed 12-29-14; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 86, Number 98 (Monday, May 24, 2021)]
[Notices]
[Page 27867]
[FR Doc No: 2021-10835]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2021-0177]

Collection of Information Under Review by Office of Management
and Budget; OMB Control Number 1625-0100

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding an Information Collection Request (ICR),
abstracted below, to the Office of Management and Budget (OMB), Office
of Information and Regulatory Affairs (OIRA), requesting an extension
of its approval for the following collection of information: 1625-0100,
Advanced Notice of Vessel Arrival; without change. Our ICR describes
the information we seek to collect from the public. Review and comments
by OIRA ensure we only impose paperwork burdens commensurate with our
performance of duties.

DATES: You may submit comments to the Coast Guard and OIRA on or before
June 23, 2021.

ADDRESSES: Comments to the Coast Guard should be submitted using the
Federal eRulemaking Portal at https://www.regulations.gov. Search for
docket number [USCG-2021-0177]. Written comments and recommendations to
OIRA for the proposed information collection should be sent within 30
days of publication of this notice to https://www.reginfo.gov/public/do/PRAMain.
    Find this particular information collection by selecting
``Currently under 30-day Review--Open for Public Comments'' or by using
the search function.
    A copy of the ICR is available through the docket on the internet
at https://www.regulations.gov. Additionally, copies are available
from: Commandant (CG-6P), Attn: Paperwork Reduction Act Manager, U.S.
Coast Guard, 2703 Martin Luther King Jr. Ave. SE, STOP 7710,
Washington, DC 20593-7710.

FOR FURTHER INFORMATION CONTACT: A.L. Craig, Office of Privacy
Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>, for questions
on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. These comments
will help OIRA determine whether to approve the ICR referred to in this
Notice.
    We encourage you to respond to this request by submitting comments
and related materials. Comments to Coast Guard or OIRA must contain the
OMB Control Number of the ICR. They must also contain the docket number
of this request, [USCG-2021-0177], and must be received by June 23,
2021.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at https://www.regulations.gov and
can be viewed by following that website's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments to the Coast Guard will
be posted without change to https://www.regulations.gov and will
include any personal information you have provided. For more about
privacy and submissions to the Coast Guard in response to this
document, see DHS's eRulemaking System of Records notice (85 FR 14226,
March 11, 2020). For more about privacy and submissions to OIRA in
response to this document, see the https://www.reginfo.gov, comment-
submission web page. OIRA posts its decisions on ICRs online at https://www.reginfo.gov/public/do/PRAMain after the comment period for each
ICR. An OMB Notice of Action on each ICR will become available via a
hyperlink in the OMB Control Number: 1625-0100.

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard published the 60-day notice (86 FR 13569, March 9, 2021)
required by 44 U.S.C. 3506(c)(2). That notice elicited no comments.
Accordingly, no changes have been made to the Collection.

Information Collection Request

    Title: Advanced Notice of Vessel Arrival.
    OMB Control Number: 1625-0100.
    Summary: The Ports and Waterways Safety Act authorizes the Coast
Guard to require pre-arrival messages from any vessel entering a port
or place in the United States.
    Need: This information is required under 33 CFR 146 and 33 CFR 160
subpart C to control vessel traffic, develop contingency plans, and
enforce regulations.
    Forms: None.
    Respondents: Vessel owners and operators.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden remains 104,515 hours a
year.
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. chapter
35, as amended.

    Dated: May 18, 2021.
Kathleen Claffie,
Chief, Office of Privacy Management, U.S. Coast Guard.
[FR Doc. 2021-10835 Filed 5-21-21; 8:45 am]
BILLING CODE 9110-04-P