BIOPESTICIDES REGISTRATION ACTION DOCUMENT
L-Lactic Acid
U.S. Environmental Protection Agency
Office of Pesticide Programs
Biopesticides and Pollution Prevention Division
June 2009
This document is for informational purposes only and is representative of the Agency's justification in registering
products containing this active ingredient. This is not a legal document.
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TABLE OF CONTENTS
I. EXECUTIVE SUMMARY: 5
II. ACTIVE INGREDIENT OVERVIEW 7
III. REGULATORY BACKGROUND 7
A. Classification 8
B. Food Clearances and Tolerances 8
IV. RISK ASSESSMENT 8
A. Active Ingredient Characterization 8
B. Human Health Assessment 9
1. Toxicology 9
2. Dose Response Assessment 11
3. Drinking Water Exposure and Risk
Characterization 7
4.. Occupational, Residential, School and Day Care Exposure and Risk
Characterization 11
5. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation
11
6. Cumulative Effects 11
7. Risk Characterization 12
C. ENVIRONMENTAL ASSESSMENT 12
1. Ecological Hazards 12
2. Environmental Fate and Ground Water Data 12
3. Ecological Exposure and Risk Characterization 12
4. Endangered Species Assessment 10
D. EFFICACY DATA 12
V. RISK MANAGEMENT DECISION 13
A. Determination of Eligibility for Registration Error! Bookmark not defined.
B. Regulatory Decision 14
VI. ACTIONS REQUIRED BY REGISTRANTS 14
A. Determination of Eligibility for Registration Error! Bookmark not defined.
B. Reporting of Hypersensitivity Incidents 15
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VII. APPENDIX A. Data Requirements (40 CFR Part 158) 16
VIII. APPENDIX B. Product Specific Information 14
IX. APPENDIX C. References 20
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BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM
Office of Pesticide Programs:
Biopesticides and Pollution Prevention Division
Biochemical Pesticides Branch (BPB)
Staff Name Title, Position
Andrew Bryceland Regulatory Action Leader
Russell Jones Senior Scientist
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I. EXECUTIVE SUMMARY:
Lactic acid has two optical isomers. One is known as L-(+)-Lactic acid and the other, its mirror
image, is D-(-)-Lactic acid. L-(+)-Lactic acid is the biologically important isomer. L-Lactic
acid, known by the IUPAC systematic name 2-hydroxypropanoic acid, is an organic acid
belonging to the family of carboxylic acids. L-Lactic acid is a colorless liquid and very highly
soluble in water. L-Lactic acid, also known as milk acid occurs naturally in several foods and is
primarily found in fermented milk products, such as: sour milk, cheese, buttermilk and yogurt.
Lactic acid also occurs naturally in meats, fruits, tomato juice, beer, wine, molasses, blood and
muscles of animals, and in the soil. L-Lactic acid was first isolated in 1780 by a Swedish
chemist, Carl Wilhelm Scheele, and is produced commercially by fermentation of carbohydrates
such as glucose, sucrose, or lactose. L-Lactic Acid is registered as a biochemical pesticide used
as a mosquito attractant (in traps).
L-Lactic acid is a product of the anaerobic (without oxygen) phase of glucose metabolism
(glycolysis) plant and animal cells use for energy. When insufficient oxygen is available for
cells to derive maximum energy from glucose (e.g., bursts of spontaneous activity in muscle
cells requiring more oxygen than is available) excess L-Lactic Acid is produced and diffuses out
of the cells. L-Lactic acid is normally found in the blood and interstitial fluid of humans at a
level of 10 mg/dl.(Ref 4) It has also been noted in a previous Agency review that (Ref. 4):
Many plants have the ability to accumulate large amounts of lactic acid; barley plants can have a
typical concentration of pyruvic and lactic acid at 15 mg /100 grams fresh weight. Lactic acid is
found in man and other animals; the normal lactic acid concentration in arterial blood ranges from
5to20mg/dl(100ml).
Normal human urine generally contains 50 to 200 mg of lactic acid per 24 hours (Ref. 4).
The previous Agency review (Ref. 4) also cited the FDA classification of lactic acid as Generally
Recognized as Safe (GRAS; 21 CFR ,180.1061) for use in food as long as good manufacturing
practices are maintained. An exemption from the requirement of a tolerance was granted for
lactic acid when used as a plant growth regulator on May 4, 1988 (40 CFR 180.1090). L-lactic
Acid is registered as an active ingredient in four end-use products and one manufacturing-use
product. The manufacturing use product contains 80% L-Lactic Acid, and the end-use products
contain between 6.5% and 35.4% L-Lactic Acid. All of the biochemical pesticide end-use
products that are currently registered are in traps used for mosquitoes. L-Lactic Acid functions
as a mosquito attractant. There is currently no L-Lactic Acid end use products for use on food or
feed. The racemic mixture of lactic acid (the D and L isomers) is also approved for use as an
inert ingredient. L-Lactic Acid is also classified by the Food and Drug Administration (FDA) as
generally recognized as safe (GRAS) for use in food (21 CFR 180.1061).
L-Lactic Acid has a very low pH (<1) and is a severe irritant. The acute toxicity studies for the
technical grade active ingredient are limited because the test substance (80% L-Lactic Acid) has
a very low pH and it is a severe irritant. Acute toxicity studies for oral, dermal, inhalation,
dermal irritation and skin sensitization demonstrate the low toxicity potential of L-Lactic Acid
(Table 3).
All subchronic, and chronic toxicity and mutagenicity data requirements were waived in 1988 on
the basis of the natural occurrence of L-Lactic Acid in plants and animals as well as its role in
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glucose metabolism for cellular energy production. This reasoning is also appropriate for waiver
of the developmental toxicity study typically required for the biochemical pesticide product uses
such as the mosquito lures.
Toxicity studies were submitted to the Agency in 1984, 1987, 1988 and 1992. EPA has
determined that there would be no human health concerns with the use of L-Lactic Acid in
pesticide products (Refs. 1, 4, & 6). Concentrated lactic acid is a severe skin irritant (Toxicity
Category I), but it is a ubiquitous metabolite in glycolysis and has no other toxic effects
associated with its registered uses. Occupational and residential risks are expected to be minimal
or non-existent. Exposure and risk are further reduced since all of the biochemical pesticide L-
Lactic Acid end use products are used in traps for mosquito control, and by requiring protective
clothing and eyewear labeling for the manufacturing use product label.
L-Lactic Acid is practically non-toxic to birds, fish, aquatic invertebrates, and honey bees (Table
4). Based on use patterns in traps for biopesticide end-use products, low exposure levels,
chemical's natural occurrence in the environment and living organisms and low toxicity potential
of L-Lactic Acid, the Agency expects that the registered uses of L-Lactic 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) (Ref 2). There are no concerns for non-
target insects in regard to outdoor uses of L-Lactic acid in traps because this active ingredient is
only attractive to blood-seeking insects, such as mosquitoes (Ref. 2).
The Biopesticides and Pollution Prevention Division (BPPD) reviewed data requirements for
granting registration under Section 3(c)(5) of the Federal Insecticide, Fungicide and Rodenticide
Act (FIFRA). It was determined that the data/information submitted adequately satisfy current
guideline requirements (refer to 40 CFR Subpart U § 158.2000). Based on information in the
Agency's database (public literature cited under MRID 458837-01) L-Lactic Acid is attractive to
mosquitoes, L-Lactic acid emanations from human skin are a major factor in determining the
relative attractiveness of different human hosts to mosquitoes, and the attractivity of L-Lactic
Acid is concentration dependent.
For definitions of scientific terms, please refer to Appendix C Glossary of Terms and
Abbreviations.
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II. ACTIVE INGREDIENT OVERVIEW
Common Name: L-Lactic Acid
Chemical Names: 2-Hydroxypropanoic acid
(S)-2-Hydroxypropionic acid
L-(+)-alpha-Hydroxypropionicacid
Propanoic acid, 2-hydroxy-, (S)-
(S)-(+)-Lactic acid
Sarcolactic acid
L(+)-Lactic Acid
Trade & Other Names: (2S)-2-hydroxypropanoic acid
L (+)Lactic acid
Propel, SY-83
CAS Registry Number: 79-33-4
OPP Chemical Code: 128929
Type of Pesticide: Biochemical pesticide, currently L-Lactic Acid is used as a biting insect
and mosquito attractant in traps.
Application rates and methods vary depending on the product. For specific information
regarding the productfsj refer to Appendix B.
III. REGULATORY BACKGROUND
L-Lactic Acid was first registered as a pesticide in 1988 as a plant-growth regulator. There are
currently no L-Lactic Acid end use pesticide products for use as a plant growth regulator.
An exemption from the requirement of a tolerance for residues of Lactic Acid when used as a
plant growth regulator in or on all raw agricultural commodities has been established (40 CFR
180.1090; 53 FR 15286; May 4, 1988).
The Agency reassessed the active and inert tolerance exemptions for L-Lactic Acid in July, 2002
as an active and inert ingredient. The tolerances that were reassessed included both inert [40
CFR 180.930, 40 CFR 180.940(c), and 40 CFR 180.950] and plant growth regulator active
ingredient (40 CFR 180.1090). In July 2002, the Agency concluded that "based on the
Agency's review and evaluation of the available information, the Agency concluded that there
was a reasonable certainty that no harm will result to the general population, and to infants and
children from aggregate exposure to L-Lactic Acid residues (U.S EPA 2002)."
In 2008 the Agency began the registration review process for L-Lactic Acid. On July 2, 2008,
the Agency announced in the Federal Register (Volume 73; Number 128; FRL-8730-1),
Registration Review of L-Lactic Acid and published for public comment USEPA L-Lactic Acid
Summary Document Registration Review: Initial Docket June 2008 (Docket ID Number: EPA-
HQ-OPP-2008-0383). This document contained the Preliminary Work Plan. No public
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comments were received. On December 24, 2008, the Agency announce in the Federal Register
(Volume 73; Number 248; FRL-8391-4) that the Final Work Plan and Proposed Registration
Review Decision combined document was open for public comment, and no public comments
were received. At the time of this writing, the Biopesticides and Pollution Prevention Division
maintains the registrations for one manufacturing use product registration and four end-use
product registrations. The end-use product registrations are all in traps for use against
mosquitoes.
A. Classification
On May 14, 1997 the Biochemical Classification Committee classified L-Lactic Acid a
biochemical pesticide due to its non-toxic mode of action, natural occurrence in the environment,
and history of exposure to humans and the environment demonstrating minimal toxicity.
In addition to being registered as a biochemical pesticide, L-Lactic acid is also registered as an
antimicrobial pesticide. The antimicrobial pesticide registrations are administered by the
Antimicrobials Division. L-Lactic Acid is used, as an antimicrobial pesticide, as a disinfectant,
indirect food contact surface sanitizer, fungicide and virucide on hard, non-porous surfaces (EPA
Federal Register Volume 67, Number 170, Pub. 9/3/2002). There are six antimicrobial pesticide
registrations; all six are for end-use products used to sanitize surfaces in residences, public
restrooms, hospitals, daycare centers, malls, schools, and nursing homes (Ref. 1).
B. Food Clearances/Tolerances
There are no registered uses for L-Lactic Acid on food or feed commodities and therefore a
tolerance or exemption from the requirement of a tolerance is not relevant. However, it is
important to note that a tolerance exemption for L-Lactic Acid has been established when used
as a plant growth regulator in or on all raw agricultural commodities under 40 CFR 180.1090.
IV. RISK ASSESSMENT
A. Active Ingredient Characterization
L-Lactic acid, known by the IUPAC systematic name 2-hydroxypropanoic acid, is an organic
acid belonging to the family of carboxylic acids. L-Lactic Acid, also known as milk acid occurs
naturally in several foods and is primarily found in fermented milk products, such as: sour milk,
cheese, buttermilk and yogurt. L-Lactic Acid also occurs naturally in meats, fruits, tomato juice,
beer, wine, molasses, blood and muscles of animals, and in the soil. L-Lactic Acid was first
isolated in 1780 by a Swedish chemist, Carl Wilhelm Scheele, and is produced commercially by
fermentation of carbohydrates such as glucose, sucrose, or lactose. Lactic acid has two optical
isomers. One is known as L-(+)-Lactic acid and the other, its mirror image, is D-(-)-Lactic acid.
L-(+)-Lactic acid is the biologically important isomer. L-Lactic Acid is registered as a
biochemical pesticide used as a mosquito attractant (in traps).
L-Lactic Acid is a product of the anaerobic (without oxygen) phase of glucose metabolism
(glycolysis) plant and animal cells use for energy. When insufficient oxygen is available for
cells to derive maximum energy from glucose (e.g., bursts of spontaneous activity in muscle
cells requiring more oxygen than is available) excess L-Lactic Acid is produced and diffuses out
of the cells.
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The mode of action of L-Lactic Acid is to function as an attractant for biting insects and
mosquitoes in traps.
All product chemistry data requirements for registration of L-Lactic Acid have been satisfied.
Refer to Table 1 in Appendix A for the summary of product chemistry data requirements.
L-Lactic acid is a colorless liquid and very highly soluble in water. L-Lactic Acid has a very
low pH (<1) and is a severe irritant. Refer to Table 2 in Appendix A for the summary of physical
and chemical characteristics for L-Lactic Acid.
B. Human Health Assessment
1. Toxicology
For acute toxicity data requirements, toxicity categories are assigned based on the hazard(s)
identified from studies and/or information on file with the Agency. The active ingredient 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.
http ://www. epa. gov/oppfead l/labeling/lrm/chap-07.htm#IIB
Adequate mammalian toxicology data/information are available to support registration review of
L-Lactic Acid. Refer to Appendix A, Table 3. All toxicology data requirements for L-Lactic
Acid have been satisfied.
a. Acute Toxicity
Acute toxicity testing is required to 1) determine systemic toxicity from acute exposure via the
dermal, inhalation and oral routes, 2) determine irritant effects from exposure to the eyes and 3)
determine the potential for skin sensitization (allergic contact dermatitis).
The acute toxicity studies are limited because the test substance (80% lactic acid) has a very low
pH (<1). At high concentrations (e.g. 80%), L-lactic acid is a severe dermal irritant in rabbits
(Tox Category I) but not a skin sensitizer; L-Lactic Acid has medium toxicity (Tox Category III)
for dermal (rabbit) and oral (rat) and low toxicity via the inhalation route (Tox Category IV) of
exposure. The eye irritation study was waived because of L-Lactic Acid's irritant properties in
skin.
For more information regarding the acute toxicity data requirements, refer to Table 3 in
Appendix A.
b. Subchronic Toxicity
All subchronic data requirements have been waived on the basis of the natural occurrence of L-
Lactic Acid in plants and animals as well as its role in glucose metabolism for cellular energy
production.
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c. Developmental Toxicity and Mutagenicity
All mutagenicity data requirements have been waived on the basis of the natural occurrence of
L-Lactic Acid in plants and animals as well as its role in glucose metabolism for cellular energy
production. This reasoning is also appropriate for waiver of the developmental toxicity study
typically required for residential uses such as the mosquito lures described in Table 5, Appendix
B.
d. Chronic Toxicity (Tier II/Tier III information)
All chronic data requirements have been waived on the basis of the natural occurrence of L-
Lactic Acid in plants and animals as well as its role in glucose metabolism for cellular energy
production.
e. Effects on the Endocrine System
EPA is required under the Federal Food, Drug, and Cosmetics Act (FFDCA), as amended by the
Food Quality Protection Act (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 Disrupter Screening and Testing Advisory Committee (EDSTAC), EPA determined
that there was scientific basis for including, as part of the program, the androgen and thyroid
hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's
recommendation that the program include evaluations of potential effects in wildlife. For
pesticide chemicals, the Agency will use FIFRA and, to the extent that effects in wildlife may
help determine whether a substance may have an effect in humans, FFDCA authority to require
the wildlife evaluations. As the science develops and resources allow, screening of additional
hormone systems may be added to the Endocrine Disrupter Screening Program (EDSP).
The Agency is not requiring information on the endocrine effects of L-Lactic Acid at this time.
The Agency has considered, among other relevant factors, available information concerning
whether the active ingredient may have an effect on humans similar to an effect produced by
naturally-occurring estrogen or other endocrine effects. There is no known metabolite that acts as
an endocrine disrupter produced by this active ingredient. Based on the low potential exposure
level associated with the proposed use (i.e., traps), the natural occurrence of L-Lactic Acid in
plants and animals, and as well as its role in glucose metabolism for cellular energy production
the Agency expects no incremental adverse effects to the endocrine or immune systems.
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2. Dose Response Assessment
Although the toxicity database for L-Lactic Acid is limited, the toxicity profile indicates no
significant systemic toxicity even at high dose levels. Therefore, a quantitative assessment is not
being conducted and no human health toxicity endpoints for the active ingredient L-Lactic Acid
have been selected.
3. Drinking Water Exposure and Risk Characterization
Currently the only biochemical pesticide end-use products that L-Lactic Acid is used in traps for
mosquito control. Because of the low toxicity associated with L-Lactic Acid, its ubiquity in the
environment, and its existing tolerance exemption, any risk of dietary exposure from drinking
water is not of concern (i.e use in traps). Therefore, drinking water exposure and risk will not be
assessed for L-Lactic Acid.
4. Occupational, Residential, School and Day Care Exposure and Risk Characterization
a. Occupational Exposure and Risk Characterization
Occupational exposure to workers who mix, load, and apply L-Lactic Acid is anticipated;
however, a risk assessment is not needed based on the low toxicity. The Agency will require the
appropriate signal word and precautionary statements to mitigate any risk from exposure.
b. Residential, School and Day Care Exposure and Risk Characterization
Based on the registered uses of L-Lactic Acid, in traps for mosquitoes, potential residential
exposure is anticipated. However, because of the dilution and low toxicity of L-Lactic Acid,
adverse effects from L-Lactic Acid are not expected. No school, or day care uses currently
appear on any L-Lactic Acid labels.
5. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation
There is reasonable certainty that no harm to the US population will result from aggregate
exposure to L-Lactic Acid. This includes all exposures for which there is reliable information.
The Agency arrived at this conclusion based on the toxicity profile indicates no systemic toxicity
even at high dose levels. The risks from aggregate exposure via oral, dermal and inhalation
exposure are negligible.
6. Cumulative Effects
Based on the information available to the Agency, there is no indication that toxic effects
associated with exposure to L-Lactic Acid are cumulative. Because of L-Lactic Acid's low
toxicity, cumulative effects with other substances that share a common mechanism of toxicity
are not expected.
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7. Risk Characterization
The Agency considered human exposure to L-Lactic Acid in light of the relevant safety factors
in FQPA and FIFRA. A determination has been made that no unreasonable adverse effects to
the U.S. population in general, and to infants and children in particular, will result from the use
of L-Lactic Acid when label instructions are followed.
C. ENVIRONMENTAL ASSESSMENT
1. Ecological Hazards
Adequate non-target toxicology data/information are available to support registration of L-
Lactic Acid. All non-target toxicology data requirements for L-Lactic Acid have been satisfied.
L-Lactic Acid is considered to be non-toxic to birds, fish, aquatic invertebrates, and bees. For
more information regarding the non-target toxicity data requirements, refer to Table 4 in
Appendix A.
2. Environmental Fate and Ground Water Data
The need for environmental fate and groundwater data was not triggered because results of the
acute toxicity studies did not trigger any additional Tier I studies.
3. Ecological Exposure and Risk Characterization
As stated above, L-Lactic Acid is considered to be non-toxic to birds, fish, aquatic invertebrates,
and bees. The use of L-Lactic Acid is not expected to cause adverse effects to non-target
organisms including endangered species based on available ecotoxicity data which demonstrate
that L-Lactic Acid is practically non-toxic, and because of the natural occurrence of lactic acid.
Therefore an environmental risk assessment was not performed for L-Lactic acid. Further, based
on use patterns and low exposure levels, the Agency does not anticipate the need for new data or
the need to conduct an environmental risk assessment.
4. Endangered Species Assessment
L-Lactic Acid is practically non-toxic to non-target organisms while the exposure levels from the
registered use pattern, which is in, the biopesticide product, mosquito traps is low. In addition
the chemical naturally occurs in the environment and living organisms. Based on the low
toxicity, low exposure potential from the biopesticide use, and the natural occurrence in the
environment and living organisms, the Agency expects that the registered uses of L-Lactic 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). There are no concerns for non-
target insects in regard to outdoor uses of L-Lactic acid in traps because this active ingredient is
only attractive to blood-seeking insects, such as mosquitoes.
D. PRODUCT PERFORMANCE DATA (EFFICACY)
Submission of product performance data (OPPTS 810.3000) is listed as a requirement for all
pesticide products. Customarily, the Agency requires efficacy data to be submitted for review
only in connection with the registration of products directly pertaining to the mitigation of
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disease bearing human health organisms and certain designated quarantine pests, i.e., ticks,
mosquitoes, fleas, Mediterranean fruit flies, gypsy moths, Japanese beetles, etc. For a list of
organisms considered by the Agency as "public health pests", please refer to Pesticide
Registration Notice 2002-1 (http://www.epa.gov/PRJSfotices/pr2002-l.pdf).
Based on information in the Agency's database (public literature cited under MRID 458837-01)
lactic acid is attractive to mosquitoes, L-Lactic Acid emanations from human skin are a major
factor in determining the relative attractiveness of different human hosts to mosquitoes, and the
attractivity of L-Lactic Acid is concentration dependent (Ref 8). The public literature that is
cited in MRID 458837-01, are listed below:
Acree, F., et al. 1968. L-Lactic Acid: A mosquito attractant isolated from humans. Science
161: 1948.
Shirai, Y. et al. 2000. Proboscis amputation facilitates the study of mosquito (Diptera:
Culicidae) attractants, repellents, and host preference. J. Med. Entomol. 37(4): 637-639.
Smith, C.N., et al. 1970. L-Lactic acid as a factor in the attraction of Aedes aegypti (Diptera:
Culicidae) to human hosts Ann. Entomol. Soc. Amer. 63(3): 760-770.
Steib, B.M., et al. 2001. The effect of lactic acid on odour-related host preference of yellow
fever mosquitoes. Chem. Senses 26: 523-528.
V. Risk Management Decision
A. Determination of Eligibility for Registration Review
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
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/oppsrrdl/registration_review/.
Pursuant to 40 CFR Sec. 155.50, the Agency formally initiated Registration Review for L-Lactic
Acid with the following timeline:
• June 2008 - publication of a Preliminary Work Plan (PWP) in the initial docket for L-
Lactic Acid (EPA-HQ-OPP-2007-1040). During the 90 day comment period that closed
on September 2, 2008, the Agency received no comments from the public.
• 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 L-Lactic Acid and meet the requirements of
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registration review. During the 60 day comment period that closed on February 27, 2009,
the Agency received no comments from the public.
• June 2009 - Issuance of a Final Registration Review Decision.
The Agency's Final Decision is that no additional data are required at this time to support the
continued registration of L-Lactic Acid. The Agency has considered L-Lactic 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 L-Lactic Acid when currently required label instructions are followed. The Final Decision
Document for L-Lactic Acid is not expected to require further data requirements for currently
registered pesticide products containing L-Lactic Acid. However, if additional information is
submitted that warrants further risk assessment, the Agency will then conduct any necessary risk
assessment(s) prior to issuing the Final Registration Review Decision.
The data and information evaluated to support L-Lactic Acid (case 6062) as published in the PWP
(June 2008) continue to support this pesticide registration as summarized herein and in the
Registration Review Final Decision which is available on http//www. epa.gov/oppsrrdl/registration
review/ review/.
B. Regulatory Decision
The data submitted fulfill the requirements of registration review for use in traps as a mosquito
attractant. Refer to Appendix B for product-specific information.
C. 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 L-Lactic Acid will cause harm or
a disproportionate impact on at-risk communities. In the Preliminary Work Plan dated June 25th,
2008, and L-Lactic Acid Final Work Plan and Proposed Registration Review Final Decision
Registration Review Case 6062 dated December 2nd, 2008, the Agency sought comment on
environmental justice issues regarding L-Lactic Acid. No comments were received.
For additional information regarding environmental justice issues, please visit EPA 's website
at: http://www. epa. sov/compliance/environmentaliustice/index. html.
VI. ACTIONS REQUIRED BY REGISTRANTS
The Agency evaluated all of the data submitted in connection with the registration review of L-
Lactic Acid and determined that these data are sufficient to satisfy current registration data
requirements. No additional data are required to be submitted to the Agency at this time. For
new uses and/or changes to existing uses, additional data may be required.
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Not withstanding the information stated in the previous paragraph, it should be clearly
understood that certain, specific, data are required to be reported to the Agency as a requirement
for maintaining the Federal registration for a pesticide product. A brief summary of these types
of data are listed below.
A. Reporting of Adverse Effects
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).
B. Reporting of Hypersensitivity Incidents
Additionally, all incidents of hypersensitivity (including both suspected and confirmed incidents)
must be reported to the Agency under the provisions of 40 CFR Part 158.2050(d).
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VII. Appendix A. Data Requirements (40 CFR Part 158-Subpart U)
*NOTE: MRID numbers listed in the following tables are representative of supporting data for
the original registration of the product containing this active ingredient. Subsequent to this
registration, there may be additional MRIDs that support registration of other products
containing this active ingredient.
TABLE 1. Product Chemistry Data Requirements for L-Lactic Acid (40 CFR § 158.2030)
OPPTS Guideline No.
830.1550
to
830.1670
830.1700
830.1750
830.1800
Study
Product identity;
Manufacturing process;
Discussion of formation of
unintentional ingredients
Analysis of samples
Certification of limits
Analytical method
Results (below are example results)
Submitted data satisfy the requirements for product
identity, manufacturing process, and discussion of
formation of impurities.
Submitted data satisfy the requirements for analysis of
samples.
Limits listed in the CSF are adequate / acceptable.
Acceptable.
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TABLE 2. Physical and Chemical Properties of L-Lactic Acid (40 CFR § 158.2030)
OPPTS Guideline No.
830.6302
830.6303
830.6304
830.6313
830.6315
830.6317
830.6319
830.6320
830.7000
830.7050
830.7100
830.7200
830.7220
830.7300
830.7520
830.7550
830.7560
830.7570
830.7840
830.7950
Property
Color
Physical State
Odor
Stability to Normal and Elevated
Temperatures, Metals and Metal Ions
Flammability
Storage Stability
Miscibility
Corrosion Characteristics
PH
UV/Visible Light Absorption
Viscosity
Melting Point/Range
Boiling Point/Range
Density
Particle Size, Fiber Length and
Diameter Distribution
Partition Coefficient (n-
Octanol/Water)
Water Solubility
Vapor Pressure
Description of Result
Colorless to Light yellow
Non-volatile liquid. Liquid at room temperature
Odorless to weakly acid
Slightly acidic
Taste: Mild acidic
Stable at normal temperatures.
Heat stability: 190-220°C
Not applicable.
Does not contain any combustible liquids.
Flash Points: Closed Cup: Higher than 93.3°C
(200°F).
Product does not deteriorate or degrade under
storage conditions. Lactic acid is a normal plant
and animal constituent. Adequate information
exists in the open literature to show lactic acid is
stable.
Not applicable. Not meant for dilution with
petroleum solvents.
Packaged in plastic container. Container is
corrosion resistant unless heated above 140°F.
DOT Classification: Class 8: Corrosive material.
Corrosive liquid.
pH = 0.6
Not applicable
28.50 cP at a lactic acid concentration of 85.3%
Not applicable. Product is a liquid.
190°Cat760mmHg
1 19-122 °C at 12 mm
1. 195 (at 85.3% purity) grams/ml
1.18-1. 19(5} 20°Cg/ml
Not applicable the product is a liquid
Not applicable
Technical chemical is polar
Infinitely soluble in water at 25°C
Infinitely soluble in cold water
Ether: Infinite @ 25°C
Ethanol: Infinite® 25°C
1.3mmHgat90°C
0.0284 mm Hg at 25°C (Source : EPI Suite)
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L-Lactic Acid
Biopesticides Registration Action Document
Page 18 of 22
Table 3. Human Toxicology Data Requirements for L-Lactic Acid (40 CFR § 158.2050)
Study/OPPTS Guideline No.
Acute oral toxicity (rat)
(870.1100)
Acute dermal toxicity (rat)
(870.1200)
Acute inhalation toxicity (rat)
(870.1300)
Primary eye irritation (rabbit)
(870.2400)
Primary dermal irritation (rabbit)
(870.2500)
Dermal sensitization (guinea pig)
(870.2600)
Hypersensitivity incidents
(885.3400)
Results
LD50 = 4936 mg/kg (males)
3543 (females)
LD50 > 2000 mg/kg (no deaths)
LC50 > 5 mg/1
Waived because L-Lactic Acid is a severe
irritant due to low pH*
Severe irritant
Not a sensitizer
No incidents were reported for L-Lactic Acid's use
as a biochemical pesticide. However 2 incidents
were reported for its use as an antimicrobial
pesticide.
Toxicity
Category /Description
III
III
IV
I
I
—
* Data requirement was waived in 1988 because the test material (80% L-Lactic Acid has a pH < 1, and is a severe
irritant.
TABLE 4. Non-Target Organism Toxicity Requirements for L-Lactic Acid (40 CFR § 158.2060)
Study/OPPTS Guideline No.
Avian acute oral toxicity
Colinus virginianus
(850.2100)
Avian dietary toxicity
Colinus virginianus
(850.2200)
Avian dietary toxicity
Anas platyrhynchos
(850.2200)
Aquatic invertebrate acute toxicity
(Daphnia magna)
(850.1010)
Freshwater fish LC50
(Oncorhynchus mykiss)
(850.1075)
Non-target insect testing (Honey Bee acute
contact)
(880.4350)
Results
LD50=>2250 mg/kg
LC5o=>5620ppm
LC5o=>5620ppm
48-hr EC50= 750 mg/1
NOEC: 320 mg/L
96-hr LC50= 130 mg/1
NOEC: 56 mg/L
LD50(ug/bee) = >100.4 ug/bee
Toxicity
Category /Description
Practically non-toxic
Practically non-toxic
Practically non-toxic
Practically non-toxic
Practically non-toxic
Practically non-toxic
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L-Lactic Acid Page 19 of 22
Biopesticides Registration Action Document
VIII. Appendix B.
TABLE 5. Products Containing the Biochemical Pesticide L-Lactic Acid
EPA Reg. No. Product Name Signal Word Per Cent
AId
69132-1
72336-1
72563-2
72563-4
PURAC® SANILAC (manufacturing use
product - MUP)
NOsquito Stinger 2-in-l Power Bait
Lurex™
Lurex™-Cubed
a. Also contains 6.531% l-Octen-3-ol as a second active ingredient.
Danger
Caution
Caution
Caution
The active ingrec
80
5.331a
35b
35.40C
lients and inert
ingredients are in lures which are intended for use with Stinger Mosquito Killer and Stinger
Mosquito Vacuum devices. Each lure contains 0.98 g lactic acid.
b. Unspecified amount of active ingredient in a container which is designed for use with Mosquito
Magnet Biting Insect Equipment.
c. For use outdoors with Mosquito Magnet® Traps 18 g AI per lure. For indoor use with Lure Vac®
containing 9 g per lure or cartridge. Label claims efficacy for 21 days.
d. Active Ingredient.
For further specific information, please refer to EPA Docket Number: EPA-HQ-OPP-0383.
( http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=EPA-HO-
OPP-2008-0383 )
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L-Lactic Acid Page 20 of 22
Biopesticides Registration Action Document
IX. Appendix C.
REFERENCES
1) U.S. EPA June 25, 2008. USEPA L-Lactic Acid Summary Document Registration Review:
Initial Docket June 2008 (Docket ID Number: EPA-HQ-OPP-2008-0383). Docket Number:
EPA-HQ-OPP-2008-03 83
http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=EPA-HO-
OPP-2008-0383
2) U.S. EPA May 13, 2008. USEPA Memorandum from Srinivas Gowda to M. Hartman, D.
Isbell, and E. Blair., entitled "Summary of Product Chemistry, Environmental Fate, and
Ecotoxicity Data for the L-Lactic Acid Registration Review Decision Document." Docket
Number: EPA-HQ-OPP-2008-0383.
http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=EPA-HO-
OPP-2008-0383
3) U.S. EPA May 14, 2008. USEPA Memorandum from Nathan Mottl to D. Isbell, and E. Blair.,
entitled "Summary of Human Health Effects Data for the L-Lactic Acid Registration Review
Decision Document." Docket Number: EPA-HQ-OPP-2008-0383
http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=EPA-HO-
OPP-2008-0383
4) U.S. EPA April 25, 2008. USEPA Memorandum from Roger Gardner to A. Bryceland.,
entitled "Registration Review: Lactic Acid Preliminary Human Health Document." Docket
Number: EPA-HQ-OPP-2008-0383
http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=EPA-HQ-
OPP-2008-0383
5) U.S. EPA July 29, 2002. USEPA Memorandum from Kathryn Boyle and K. Leifer to R.
Forrest., entitled: IIFG Decision Document on Reassessing Tolerance Exemptions for Lactic
Acid." (EPA-HG-OPP-2003-0230).
6) U.S. EPA April 29, 1988. USEPA Pesticide Fact Sheet for Lactic Acid. Docket Number:
EPA-HQ-OPP-2008-03 83
http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=EPA-HO-
OPP-2008-0383
7) U.S. EPA December 2, 2008. USEPA L-Lactic Acid Final Work Plan and Proposed
Registration Review Final Decision Registration Review Case 6062. Docket Number: EPA-HQ-
OPP-2008-0383
http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=EPA-HO-
OPP-2008-0383
8) U.S. EPA Memorandum. January 24, 2004. Science Review in Support of the Registration of
Lurex (EPA File Symbol 72563-E). MRID Number 458837-01. From Dr. R.S. Jones. To Dr. T.
Peterson.
9) U.S. EPA June 2009. USEPA L-Lactic Acid Final Registration Review Decision.
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L-Lactic Acid Page 21 of 22
Biopesticides Registration Action Document
Registration Review Case 6062. Docket Number: EPA-HQ-OPP-2008-0383.
http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&d=EPA-HO-
OPP-2008-0383-0013
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
ED WC Estimated Drinking Water Concentration
EEC Estimated Environmental Concentration
EPA Environmental Protection Agency
EUP End-Use Product
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
FOB Functional Observation Battery
GENEEC Tier I Surface Water Computer Model
IR Index Reservoir
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be expected to
cause death in 50% of test animals. It is usually expressed as the weight of substance per
weight or volume of water, air or feed, e.g., mg/1, 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
ug/g Micrograms Per Gram
ug/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
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L-Lactic Acid Page 22 of 22
Biopesticides Registration Action Document
PDF 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
Qi * 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(c)) of FIFRA)
TGAI Technical Grade Active Ingredient
TEP Typical End-Use Product
USDA United States Department of Agriculture
UF Uncertainty Factor
WPS Worker Protection Standard
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