Document ID: EPA-HQ-OPP-2008-0477-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-01-08T05:00Z

SEQ CHAPTER \h \r 1 United States 			Prevention, Pesticides	December
2008

                Environmental Protection                       and Toxic
Substances

                Agency                                                  
(7510P)

Caprylic (Octanoic) Acid

Final Work Plan and 

Proposed Registration Review Final Decision

Registration Review Case 5028



Docket Number EPA-HQ-OPP-2008-0477

Caprylic (Octanoic) Acid

Final Work Plan and 

Proposed Registration Review Final Decision

Registration Review Case 5028

				

			

		

			Approved by: _____________________                      

								Joan Harrigan-Farrelly, Director

								Antimicrobials Division

								Date: ______________________

Table of Contents

Final Work Plan and Proposed Registration Review Final Decision for

Caprylic (Octanoic) Acid, Case 5028

Caprylic (Octanoic) Acid Registration Review Team
Members…………………	4

I.
Introduction…………...….…………………………………
……………………..	  5

II. Scientific Assessment
……………………………………………………………	6

A.  Chemical
Identification………………………………………………….
6

B.  Product
Chemistry………………………………………………………
.	7

C.  Human Health Risk Assessment
Status………………………………...	9

D.  Environmental Fate and Ecological Effects Exposure and Risk
Assessment
Status……………………………………………………..…
13

E. 
Incidents………………………………………………………
…………..	14

F. Public
Comments………………………………………………………
…	14

G.  Environmental
Justice…...……………………………………………...	14

H.  Water
Quality………………………………………………………
……	15

I.  Trade
Irritants………………………………………………………
……	15

III. Registration Review Proposed Final
Decision…………………………………	 15

IV. Next Steps and
Timeline……………..………………….……………...……
…	15

V. Glossary of Terms and Abbreviations
………………………………………….	17

Caprylic (Octanoic) Acid Registration Review Team

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

William Hazel

Srinivas Gowda

Risk Management

ShaRon Carlisle

Diane Isbell

I.  INTRODUCTION

 

	This document is EPA’s Final Work Plan and Proposed Registration
Review Final Decision for Caprylic (Octanoic) Acid and is being issued
pursuant to 40 CFR Sections 155.57 and 155.58.  A registration review
decision is the Agency’s determination that a pesticide meets, or
continues to meet the standard for registration in FIFRA.  For
additional information on Caprylic (Octanoic) Acid, additional documents
can be found in EPA’s public docket (EPA-HQ-OPP-2008-0477) at  
HYPERLINK "http://www.regulations.gov"  www.regulations.gov .  

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

	In 2006, the Agency implemented the Registration Review program
pursuant to FIFRA Section 3(g) and will review each registered pesticide
every 15 years to determine whether it continues to meet the FIFRA
standard for registration.   		

	Pursuant to 40 CFR Sec. 155.50, the Agency formally initiated
registration review for Caprylic (Octanoic) Acid with the following
timeline:

July 2008 – publication of a Preliminary Work Plan (PWP) in the
initial docket for Caprylic (Octanoic) Acid (EPA-HQ-OPP-2008-0477). 
During the 90 day public comment period that closed on October 7, 2008,
the Agency received no comments.  

December 2008 – Issuance of a Final Work Plan and Proposed
Registration Review Final Decision stating that the most recent exposure
and risk assessments still supported the registration of pesticide
products containing Caprylic (Octanoic) Acid and meet the requirements
of registration review under 40 CFR Sec. 155.50.  This document will be
issued for a 60-day public comment period.	

	This document is a combined Final Work Plan and Proposed Registration
Review Final Decision.  No comments were received on the Preliminary
Work Plan (PWP), issued in July 2008.  Given the lack of comments and
the low toxicity of Caprylic (Octanoic) Acid, the Agency is combining
the Final Work Plan and Proposed Registration Review Final Decision
Document for this case.  In addition, the data and information evaluated
to support Caprylic (Octanoic) Acid, case 5038, as published in the PWP
dated June 24, 2008, continue to support this pesticide registration as
summarized herein.  The status of these and other registration review
cases is available on   HYPERLINK
"http/www.epa.gov/oppsrrd1/registration%20review/%20review" 
http//www.epa.gov/oppsrrd1/registration review/ review . 

Caprylic (Octanoic) Acid, also referred to as octanoic acid, is an
antimicrobial pesticide that is used as a food contact surface sanitizer
in commercial food handling establishments.  It is also used as a
disinfectant in health care facilities and as an algaecide in
greenhouses and interiorscapes on ornamentals.  In addition, Caprylic
(Octanoic) Acid is characterized by low toxicity, is biodegradable, and
is found extensively in nature.

Currently, there are seven registered products containing Caprylic
(Octanoic) Acid as an active ingredient.  This Registration Review of
Caprylic (Octanoic) Acid addresses the Caprylic (Octanoic) Acid
component of the registered products.  The other active ingredients will
be addressed during their subsequent Registration Review.  Due to the
products’ registered uses on dairy and food-processing equipment such
as tanks, vats, pails, pipelines and closed systems, there is potential
for residues in food; thus, Caprylic (Octanoic) Acid is considered to be
a food-use chemical under the Federal Food, Drug, and Cosmetic Act
(FFDCA).  However, an exemption from the requirement of a tolerance for
residues of Caprylic (Octanoic) Acid in foods has been established (40
CFR 180.940 (a)(b)(c)).  

II. SCIENTIFIC ASSESSMENT

A.  Chemical Identification

	Table 1 provides information on the chemical identity of Caprylic
(Octanoic) Acid.

Table 1.  Chemical Identity

Common Name	Caprylic acid

Chemical Name	n-octanoic acid

PC Code	128919

CAS Registry Number	124-07-2

Registration Review Case No.	5028

Empirical Formula	C8H16O2

Molecular Weight	144.24

Chemical Structure:

 

B.  Product Chemistry

	

Table 2 provides information on the physical and chemical properties of
Caprylic (Octanoic) Acid.  All product chemistry data requirements have
been fulfilled for the active ingredient Caprylic (Octanoic) Acid; no
additional data are needed at this time.

Table 2.  Product Chemistry Data Summary for Caprylic (Octanoic) Acid 

Guideline No.	Physical and Chemical Properties	Status1	Value

830.1550	Product identity and composition	A	Refer to Table 1

830.1600	Description of materials used to produce the product	A	CBI

830.1620	Description of production process	A	CBI

830.1650	Description of formulation process	A	CBI

830.1670	Discussion of formation of impurities	A	CBI

830.1700	Preliminary analysis	A	CBI

830.1750	Certified limits	A	CBI

830.1800	Enforcement analytical method	A	Gas-Liquid Chromatography 

830.1900	Submittal of samples

N/A 

830.6302	Color	A	Clear, colorless to light yellow.

830.6303	Physical State	A	Liquid. (Oily liquid)

830.6304	Odor	A	Rancid

830.6313	Stability to sunlight, normal and elevated temperature,
metals/metal ions	A	Stable under ordinary conditions of use and storage.
 

Stable under normal temperatures and pressures.

830.6314	Oxidation/Reduction: Chemical Incompatibility	A	Avoid strong
oxidizing agents

830.6315	Flammability	A	May be combustible at high temperature.  Keep
away from heat.  Keep away from sources of ignition.

Flash Points: Closed Cup: 110°C (230°F).

                       Open Cup:    132°C (269.6°F).

Flash Point: 270°F.(TOXNET)

Autoignition Temperature: 440°C

830.6316	Explodability	A	Not explodable

830.6317	Storage Stability	A	Fatty acid stability is related to the
total unsaturation of the acid mixture.  Instability is a result of free
radical reactions resulting in polymerization and chain cleavage.

830.6319	Miscibility	N/A	Not meant for dilution with petroleum solvents

830.6320	Corrosion Characteristic

	A	Non-corrosive

830.6321	Dielectric breakdown voltage	N/A	Not intended for use in or
around electrical equipment.

830.7000	pH (100%)

	A	3.8

830.7050	UV/Visible absorption	N/A

	830.7100	Viscosity	A	5.74 mPa sec (TOXNET)

Viscosity mPa·s (°C): 5.74 (20), 1.85 (75)

830.7200	Melting Point

	A	16.7°C (62.1°F)

830.7220	Boiling point	A	297.9°C

239.7°C (463.5°F) (760 mmHg)

140°C (23 mm Hg)

830.7300	Density	A	0.9105 at 20°C

0.929 ± 0.06 g/cm3

830.7300	Specific Gravity

	A	0.9088 (Water = 1)

830.7370	Dissociation Constants in water	A	pKa = 4.895 at 25°C (TOXNET)

830.7550	Octanol/water partition coefficient	A	Log Kow = 3.05 (TOXNET)

830.7840	Solubility in water (g/100ml)	A	Slightly soluble in water

0.068 g/100 g water at 20°C (68°F) (TOXNET)

0.68 g/L (20°C)

830-xxxx	Solubility in organic solvents	A	Freely soluble in alcohol,
chloroform, ether, carbon disulfide, petroleum ether, glacial acetic
acid (TOXNET)

830.7950	Vapor pressure

1 mmHg at 78.0°F (TOXNET)

<1 mm Hg at 72°F

0.02 mm of Hg at 20°C

3.440E-03 mmHg at 25°C (Measured)

0.05 hPa @ 20°C

	Hazardous Decomposition Products

Does not decompose up to 400°F

Carbon dioxide and carbon monoxide may form when heated to
decomposition.

	 Polymerization

Hazardous Polymerization will not occur.

Other Physical/Chemical Properties

Classification of a.i.

Aliphatic hydrocarbon

Carboxylic acid

	Henry's Law Constant  at 25°C 

2.34E-006 atm-m3/mole (EPI Suite)

	Log Kow   

3.03 (EPI Suite)

	Koc

Estimated Koc:  25.62 (EPI Suite) 

Log Koc: 1.4086 (EPI Suite)

	Estimated Log BCF

0.500  (BCF = 3.162) – (EPI Suite)

	Ready Biodegradability Prediction

Yes (EPI Suite).

Microbiological degradation.

	Log BCF

Log BCF = 0.500 (EPI suite)

BCF=3.162  (EPI suite)

	Photodegradation 

Half-life 15.4 Hours (AOPWIN)

	Hydrolysis

No hydrolysis

	Refractive index 

1.4268-1.4288 (20°C)

	Assay

98.00 - 100.00 %

	Calc. Log P (KowWin) 

3.03 (Source: EPI Suite)

	Theoretical Chemical Composition

Carbon      66.63%

Hydrogen  11.18%

Oxygen      22.19%

C.  Human Health Risk Assessment Status 

1.	Toxicology

	Caprylic, heptanoic, and nonanoic acids are a group of short-chained
linear fatty acids of seven, eight, and nine carbon atoms in length,
respectively.  Based on their structural similarities, toxicity data can
be used almost interchangeably as surrogate data for these three
substances.  Based on the evidence presented, the Agency used the
surrogate data from heptanoic and nonanoic acid to supplement the
available information on caprylic acid.  However, the primary source of
information for this assessment was a risk assessment by R. Quick,
(D330286), dated December 4, 2006, for a proposed use on ornamentals. 
In addition, the documentation supporting the establishment of an
exemption from the requirement of a tolerance for decanoic acid (68 FR
7935, 2/19/03) was also used, as well as, the capric acid (decanoic
acid) registration review human health scoping document. 

	

		a.	Acute Toxicity

	Data from open technical literature satisfy the requirement for acute
toxicity studies.  Acute oral toxicity LD50 values for caprylic acid
range from 1283 mg/kg to 10,080 mg/kg of body weight in rats, and a
dermal LD50 value greater than 5000 mg/kg was reported in rabbits.  No
acute inhalation data are available for caprylic acid; however, studies
have been conducted on heptanoic acid (98.5%) and nonanoic acid (97%). 
The LC50 values were greater than 4.6 mg/l for heptanoic acid and 0.46
mg/l - 3.8 mg/l for nonanoic acid.  The test substance caused a moderate
dermal reaction when 0.5 ml was applied to the skin.  Additional
information can be found at:   HYPERLINK
"http://www.epa.gov/chemrtk/pubs/summaries/alipalde/c13033tc.htm" 
http://www.epa.gov/chemrtk/pubs/summaries/alipalde/c13033tc.htm )

	Studies conducted using nonanoic acid resulted in classification into
the following Toxicity Categories:  primary, dermal and eye irritation
(Toxicity Category II), acute oral toxicity (Toxicity Category IV),
acute dermal and inhalation toxicity (Toxicity Category III). 
Sensitization test results showed that nonanoic acid is not considered a
dermal sensitizer.  Based on the information on nonanoic acid, caprylic
acid is not likely to be a dermal sensitizer.

		b. 	Subchronic and Chronic Toxicity

	No data on caprylic acid are available for subchronic and chronic
toxicity.

However, there are subchronic and chronic toxicity data for heptanoic
acid and nonanoic acid (pelargonic acid).  In a 14-day rat oral toxicity
study, no systemic toxicity was observed in either sex dosed with
pelargonic acid (nonanoic acid) as high as 20,000 ppm (1,834 mg/kg/day),
the highest dose tested.  In addition, no adverse effects were caused on
survival, clinical signs, body weight gain, food consumption,
hematology, clinical chemistry or gross pathology.  For each dose, three
animals per sex were tested; however, the study did not report organ
weights and histopathology.  This was considered a deficiency in this
study.  Nevertheless, the Agency determined that, because no systemic
toxic effects were observed at a very high dose level approaching 2,000
mg/kg/day, a 90-day oral study was not necessary (Kuhn, 1995; MRID
43843507).

	Groups (10/sex/group) of rats (Sprague-Dawley) 45 days of age were
given heptanoic acid by gavage in corn oil (10 ml/kg at doses of 0, 875,
1750, and 3500 mg/kg bw/day) daily for 27 days.  Clinical signs included
languid behavior, dyspnea, polypnea, tremors, wheezing, ataxia and
excess salivation.  Significant decreases in body weight and food
consumption (male only) were observed compared to those of the control
group.  Hyperkeratosis of the non-glandular stomach was reported in
high-dose males and females at necropsy.  No significant findings in
low- and mid-dose groups that could be related to administration of the
test material.  Clinical chemistry and hematological examinations
revealed no significant changes compared to those for the control group.
 A NOAEL of 1750 mg/kg/day and a LOAEL of 3500 mg/kg/day were determined
based on decreased body weights and food consumption and gross lesions
of the stomach (  HYPERLINK
"http://www.epa.gov/chemrtk/pubs/summaries/alipalde/c13033tc.htm" 
http://www.epa.gov/chemrtk/pubs/summaries/alipalde/c13033tc.htm ;
Terrill, 1990b).

	A 28-day dermal toxicity study conducted on rabbits was submitted to
the Agency under TSCA section 8(e).  Five male and five female New
Zealand white rabbits were dermally treated with pelargonic acid present
in mineral oil.  In all, 10 applications were made (5 per week) at a
dose level of 500 mg/kg/day.  A 2-week recovery period was allowed for
selected rabbits.  During the first and second week of treatment, slight
body weight loss and decreased food consumption were observed.  One
female rabbit showed ocular discharge and hypoactivity during the second
week of treatment.  All rabbits dermally treated with pelargonic acid by
day 14 showed signs of severe erythema and moderate edema.  Dermal
reactions consisting of moderate desquamation, moderate fissuring,
eschar, exfoliation and necrosis were also observed at day 14.  By day
29, all dermal reactions had reversed.  It was evident that at the
treatment level of 500 mg/kg/day of pelargonic acid, significant dermal
signs of toxicity were observed but no significant systemic reaction ( 
HYPERLINK
"http://www.epa.gov/chemrtk/pubs/summaries/alipalde/c13033tc.htm" 
http://www.epa.gov/chemrtk/pubs/summaries/alipalde/c13033tc.htm ; C7-C9
Consortium. 2004; Auletta, 1981).

	A similar dermal study was conducted using heptanoic acid.  A single
dose of 500 mg/kg/day of heptanoic acid in mineral oil (25% solution)
were administered to New Zealand White rabbits (5/sex/group) daily for
five days a week for two weeks with a two-week recovery period.  Most
animals exhibited a weight loss after 2 weeks of treatment, but showed
normal weight gains during the additional two-week recovery period
compared to controls.  All animals showed localized severe erythema,
slight to severe edema, necrosis, desquamation and exfoliation by the
second week of treatment.  Ocular irritation and decreased food
consumption were also observed in some animals.  All animals were free
of signs of dermal and systemic toxicity at the end of the two-week
recovery period.  Microscopic examination revealed epidermal necrosis,
epidermal hyperplasia, and hyperkeratosis at the application site. A
NOAEL of less than 500 mg/kg/day was determined   HYPERLINK
"http://www.epa.gov/chemrtk/pubs/summaries/alipalde/c13033tc.htm" 
http://www.epa.gov/chemrtk/pubs/summaries/alipalde/c13033tc.htm ; C7-C9
Consortium. 2004; Auletta, 1981).

	A supplemental study on chronic toxicity/carcinogenicity in mice was
conducted for 80 weeks.  A dose of 50 mg of pelargonic (nonanoic acid)
acid was dermally applied to each mouse twice/day for 80 weeks. 
Histopathology showed no non-neoplastic or neoplastic lesions on skins
and internal organs of mice.  The Agency concluded that although this
study was not conducted according to the guideline specifications, it
adequately assesses the chronic toxicity and the carcinogenic potential
of pelargonic (nonanoic acid) acid via the dermal route. 

		c.	Carcinogenicity

	A supplemental study on chronic toxicity/carcinogenicity in mice was
conducted for 80 weeks.  A dose of 60 mg of nananoic acid was applied
dermally to each mouse twice/day for 80 weeks.  Histopathology showed no
non-neoplastic or neoplastic lesions o skins and internal organs of
mice.  The Agency concluded that, although this study was not exactly
conducted according to guidelines, it adequately assesses the chronic
toxicity and the carcinogenic potential of nonanoic acid via the dermal
route.

		

		d.	Endocrine Effects

	EPA is required under section 408(p) of the FFDCA, as amended by FQPA,
to develop a screening program to determine whether certain substances
(including all pesticide active and other ingredients) "may have an
effect in humans that is similar to an effect produced by a
naturally-occurring estrogen, or other such endocrine effects as the
Administrator may designate."  Following the recommendations of its
Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC),
EPA determined that there was a scientific basis for including, as part
of the program, androgen and thyroid hormone systems, in addition to the
estrogen hormone system.  EPA also adopted EDSTAC’s recommendation
that it include evaluations of potential effects in wildlife.  The
Agency does not have any information with respect to potential endocrine
effects of Caprylic (Octanoic) Acid in mammalian systems.  There is no
information from the available scientific literature to suggest that
this fatty acid would have endocrine effects. 

The Agency has no direct information regarding any potential endocrine
effects of caprylic acid in mammalian systems.  There is no information
from the available scientific literature to suggest that this fatty acid
would have endocrine effects.  However, based on the weight of the
evidence of available data, no effects related to an endocrine system
have been identified or suggested for caprylic acid.  For the purposes
of this Registration Review, EPA has assumed that caprylic acid does not
disrupt endocrine systems because it elicits no adverse systemic effects
when used as an antimicrobial as registered

		2. 	Dietary, Drinking Water, Residential and Occupational Exposure

		a.	Dietary Exposure

	Caprylic acid has been classified by the Food and Drug Administration
(FDA) as a direct food additive that is Generally Recognized as Safe
(GRAS) when this naturally-occurring component of food is added as a
flavoring agent or adjuvant to various foods.  Dietary exposure is
expected to occur from the FDA direct food additive uses as well as the
EPA indirect food additive uses on dairy equipment, food processing
equipment and utensils, and in eating establishments.  However, EPA has
established exemptions from the requirement of a tolerance for residues
of caprylic acid in foods [40 CFR 180.940(a), - (b), and -(c)] because
there are no adverse systemic effects on man attributable to oral
exposure.  Therefore, a dietary exposure assessment for Caprylic
(Octanoic) Acid is not needed.

	

		b. 	Drinking Water Exposure

	The current antimicrobial indoor uses of caprylic acid are not expected
to result in residues in drinking water supplied by residential wells or
municipal sources.  In addition all use sites are indoors except for the
registered ornamental use which includes the option to apply their
product on ornamental plants raised outdoors.  As a result, dietary
exposure via drinking water may occur but is likely to be very low. 
Based on the low toxicity, knowledge that caprylic acid is
naturally-occurring, is a component of the human diet, and is recognized
by the FDA as a GRAS chemical, a dietary and drinking water risk
assessment is not needed.

		c.	Residential and Occupational Exposure

	There are currently no residential uses of caprylic acid.  However,
there is the opportunity for postapplication and bystander exposure of
adults and children to caprylic acid resulting from its use in schools,
gyms, restaurants, hospitals, etc. as sanitizers/disinfectants. 
Although exposure is likely as a result of these uses, risk assessments
are not applicable as there are no adverse systemic effects on man
attributable to dermal, inhalation, or inadvertent oral exposure.

	In addition, occupational exposure to mixer/loader/applicators is
likely from the registered uses in food and beverage processing
facilities, industrial, institutional, and commercial facilities, and on
ornamentals.  A quantitative risk assessment is not needed because of
the low toxicity.  Adverse systemic effects attributable to the dermal
and inhalation routes of exposure to caprylic acid are not expected. 
Label instructions and the requirement that handlers wear certain
personal protective equipment (PPE) such as gloves and eye covering are
sufficient to protect workers from the localized, irritation effects of
exposure to Caprylic (Octanoic) Acid.

d. 	Aggregate Exposure

	Exposure to caprylic acid could result from food, drinking water, and
postapplication/bystander sources; all of these could contribute to
aggregate risk.  As caprylic acid induces no adverse systemic effects
via any route of exposure, an aggregate risk assessment is not needed.

D.  Environmental Fate and Ecological Effects Risk Assessment Status

Environmental Fate

An environmental fate assessment has not been conducted for Caprylic
(Octanoic) Acid.  Caprylic (Octanoic) Acid is classified as a saturated
fatty acid, a group of substances which is completely biodegradable and
found extensively in nature.  Specifically, Caprylic (Octanoic) Acid
occurs in a number of plants, and animal sources such as animal oils,
fats, butter, coconut oil, etc.  It is a food-grade substance,
non-volatile and relatively inert to aqueous hydrolysis.  It is a
minimal risk and low concern inert, a normal constituent in animal diet
and is readily metabolized by all forms of life.  Microorganisms rapidly
degrade fatty acids in soil.  

		2.	Ecological Effects

The Agency has conducted a review of the scientific databases and other
relevant information supporting the reregistration of Caprylic
(Octanoic) acid, and has waived all generic data requirements for this
chemical.  Caprylic (Octanoic) acid is listed as GRAS food additive by
the Food and Drug Administration (21 CFR 172.863; as food additives
permitted for direct addition to food for human consumption).  Fatty
acids normally are metabolized, forming simple compounds that serve as
energy sources and structural components used in all living cells.  An
ecological risk assessment is not needed for Caprylic (Octanoic) Acid.  

		3. 	Endangered Species

As mentioned previously, Caprylic (Octanoic) Acid has low toxicity. 
There are seven products registered for pesticidal use; these products
are registered for indoor use and have a low percentage of this active
ingredient in the end use product (≤3.5% ai).  In addition, Caprylic
(Octanoic) Acid is classified as a saturated fatty acid, a group of
substances which is completely biodegradable and found extensively in
nature.  It is naturally occurring in vegetable oils and in animal fats
and is a significant part of the normal diets of mammals, birds and
invertebrates; it is readily metabolized by all forms of life.

Caprylic (Octanoic) Acid is not expected to contaminate ground water or
soil and does not accumulate in the food chain.  Because of the rapid
degradation of Caprylic (Octanoic) Acid into components that do not pose
a risk to aquatic organisms, the Agency is not conducting a
down-the-drain assessment.  

Based on indoor use patterns, low exposure levels, and low toxicity
potential of caprylic acid, the Agency expects that the registered uses
of caprylic acid will have “no effect” (NE) on endangered or
threatened terrestrial or aquatic species, or their designated critical
habitats, as listed by the U.S. Fish and Wildlife Service (USFWS) and
the National Oceanic and Atmospheric Administration (NOAA).

E.  Incidents

	Federal law requires registrants of pesticides to inform EPA about any
harmful effects of their products. A total of 29 incidents involving 260
individuals associated with products containing caprylic acid have been
reported in OPP Incident Data System (IDS).  The bulk of these were
reported by the registrant, Ecolab, Inc. from 1999 to 2004.  The most
common symptoms included: irritation of the lungs, throat, eyes, and
skin, nausea, dizziness, and vomiting.  The severity of the symptoms
ranged from mild to severe such as eye redness to corneal abrasions or
skin rash to blisters, edema, and erythema.  It must be noted that all
five antimicrobial products implicated also contained hydrogen peroxide
and peroxyacetic acid in addition to caprylic acid.  Although caprylic
acid is a moderate eye irritant (Toxicity Category II) and a mild dermal
and inhalation irritant (Toxicity Category III), at least one other
active ingredient in every implicated end-use product is expected to be
more severely irritating than caprylic acid, especially at the
concentrations formulated. 

 Those handling the undiluted antimicrobial product directly, i.e.,
during pouring and mixing the end-use product in/with water prior to
application, would be most at risk.  Current labels bear the following
precautionary statements:  “Causes irreversible eye damage and skin
burns. May be fatal if inhaled or absorbed through the skin.  Harmful if
swallowed. Do not get in eyes, on skin, or on clothing.  Do not breathe
vapor or spray mist.  Wear protective eyewear (goggles, face shield, or
safety glasses), protective clothing, and rubber gloves” and “When
spraying or fogging, wear a mask or pesticide respirator jointly
approved by Mine Safety and Health Administration and the National
Institute for Occupational Safety and Health.”  

F.  Public Comments  

	Pursuant to 40 CFR Sec. 155.50, the Agency formally initiated
registration review for Caprylic (Octanoic) Acid on July 7, 2008 with
the opening of a docket and the issuance of a PWP for public comment. 
The Agency received no comments concerning the Preliminary Work Plan for
Caprylic (Octanoic) Acid during the 90-day public comment period.  The
public will be invited to comment on the Proposed Registration Review
Final Decision for 60 days following the issuance of this document.

G.  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.  At this
time EPA does not believe that use of pesticide products containing
Caprylic (Octanoic) Acid will cause harm or a disproportionate impact on
at-risk communities.  In the Preliminary Work Plan dated June 24, 2008,
the Agency sought comment on environmental justice issues regarding
Caprylic (Octanoic) Acid.  As mentioned previously, no comments were
received.  

	For additional information regarding environmental justice issues,
please visit EPA’s  website at:    HYPERLINK
"http://www.epa.gov/compliance/environmentaljustice/index.html" 
http://www.epa.gov/compliance/environmentaljustice/index.html .

H.	Water Quality

Caprylic (Octanoic) Acid is not identified as a cause of impairment for
any water-bodies listed as impaired under section 303(d) of the Clean
Water Act, based on information provided at:   HYPERLINK
"http://oaspub.epa.gov/tmdl/waters_list.impairments?p_impid=3" 
http://oaspub.epa.gov/tmdl/waters_list.impairments?p_impid=3 .  The
Agency sought submission of water quality data for Caprylic (Octanoic)
Acid when the Preliminary Work Plan was issued for comment.  The Agency
did not receive any comments on water quality issues.

Trade Irritants

Through the registration review process, the Agency solicited
information on trade irritants and, to the extent feasible, took steps
toward facilitating irritant resolution.  Growers and other stakeholders
were asked to comment on any trade irritant issues resulting from lack
of Maximum Residue Levels (MRLs) or disparities in key export markets,
providing as much specificity as possible regarding the nature of the
concern.  In the case of Caprylic (Octanoic) Acid, there are indirect
food uses as Caprylic (Octanoic) Acid is registered for use as a contact
surface sanitizer in commercial food handling establishments.  In
addition, an exemption from the requirement of a tolerance for residues
has been established in 40 CFR 180.1225 and 40 CFR 180.940 (b) and (c). 
Additionally, there are no MRLs established for Caprylic (Octanoic)
Acid.  The Agency did not receive and comments regarding the existence
of any trade irritant issues associated with Caprylic (Octanoic) Acid.

III. REGISTRATION REVIEW PROPOSED FINAL DECISION

	The Agency has determined that no additional data are required at this
time to support the registration of Caprylic (Octanoic) Acid.   The
Agency has considered Caprylic (Octanoic) Acid in light of the standard
for registration and safety factors in FIFRA and FFDCA as amended by
FQPA.  EPA has found that there are not likely to be any unreasonable
adverse effects to the U.S. population in general, and to infants and
children in particular, or to non-target organisms, from the use of
products containing Caprylic (Octanoic) Acid when currently required
label instructions are followed.  The Agency has found that it is not
necessary to conduct a new risk assessment for this case and is
therefore issuing a proposed final decision pursuant to 40 CFR 155.53
(c)(2) and 40 CFR 155.58.

	As per 40 CFR Sections 155.57 and 155.58, the Agency proposes that the
standards for Registration Review have been met and that the
registrations of the aforesaid Caprylic (Octanoic) Acid products should
be maintained.  

IV. NEXT STEPS AND TIMELINE:

	Pursuant to 40 CFR Section 155.58, this Proposed Registration Review
Final Decision document is being entered into the Caprylic (Octanoic)
Acid docket (EPA-HQ-OPP-2008-0477).  The Final Work Plan is also
included in this document.  A Federal Register Notice will announce the
availability of the Proposed Registration Review Final Decision and
allow a 60 day comment period.  If there are no significant comments or
additional information submitted to the docket during that period that
lead the Agency to change its proposed decision, EPA will issue a final
decision for Caprylic (Octanoic) Acid Case 5028.   The Agency
anticipates the final decision will be issued in 2009.  

V. 	GLOSSARY of TERMS & ABBREVIATIONS

ai		Active Ingredient

AR		Anticipated Residue

ASTM		American Society for Testing and Materials

AWPA		American Wood Preserver’s Association

CFR		Code of Federal Regulations

cPAD		Chronic Population Adjusted Dose

CSF		Confidential Statement of Formula

CSFII		USDA Continuing Surveys for Food Intake by Individuals

DCI		Data Call-In

DEEM		Dietary Exposure Evaluation Model

DFR		Dislodgeable Foliar Residue

DNT		Developmental Neurotoxicity

DWLOC		Drinking Water Level of Comparison

EC		Emulsifiable Concentrate Formulation

EDWC		Estimated Drinking Water Concentration

EEC		Estimated Environmental Concentration

EPA			Environmental Protection Agency

EUP		End-Use Product

FDA		Food and Drug Administration

FIFRA		Federal Insecticide, Fungicide, and Rodenticide Act

FFDCA		Federal Food, Drug, and Cosmetic Act

FQPA		Food Quality Protection Act

FOB		Functional Observation Battery

GENEEC		Tier I Surface Water Computer Model

GRAS		Generally Recognized as Safe

IR		Index Reservoir

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

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

LOC		Level of Concern

LOAEL		Lowest Observed Adverse Effect Level

µg/g		Micrograms Per Gram

µg/L		Micrograms Per Liter

mg/kg/day		Milligram Per Kilogram Per Day

mg/L		Milligrams Per Liter

MOE		Margin of Exposure 

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

MUP		Manufacturing-Use Product

NA		Not Applicable

NAWQA		USGS National Ambient Water Quality Assessment

NPDES		National Pollutant Discharge Elimination System

NR		Not Required

NOAEL		No Observed Adverse Effect Level

OPP		EPA Office of Pesticide Programs

OPPTS		EPA Office of Prevention, Pesticides and Toxic Substances

PAD		Population Adjusted Dose

PAIRA		Pure Active Ingredient Radiolabelled

PCA		Percent Crop Area

PDP		USDA Pesticide Data Program

PHED		Pesticide Handler's Exposure Data 

PHI		Preharvest Interval

ppb		Parts Per Billion

PPE		Personal Protective Equipment

ppm		Parts Per Million

PRZM/EXAMS		Tier II Surface Water Computer Model  

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

RAC		Raw Agriculture Commodity

RED		Reregistration Eligibility Decision

REI		Restricted Entry Interval

RfD		Reference Dose

RQ		Risk Quotient

SCI-GROW		Tier I Ground Water Computer Model

SAP		Science Advisory Panel

SF		Safety Factor

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

TGAI		Technical Grade Active Ingredient

TEP		Typical End-Use Product

USDA		United States Department of Agriculture

UF		Uncertainty Factor

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