BIOPESTICIDE REGISTRATION ACTION DOCUMENT 

Draft for Public ParticipationProcess

Laminarin 

PC Code: 123200

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

Last updated- November 30, 2009
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TABLE OF CONTENTS

I. EXECUTIVE SUMMARY 

II. ACTIVE INGREDIENT OVERVIEW

III. REGULATORY BACKGROUND

IV. RISK ASSESSMENT

A. PRODUCT ANALYSIS ASSESSMENT

1. Product Chemistry and Composition

2. Analysis and Certification of Limits

3. Physical and Chemical Characteristics

B. HUMAN HEALTH ASSESSMENT

1. Toxicological Hazard Assessment

2. Dose Response 

3. Dietary Exposure and Risk Characterization

4. Drinking Water Exposure and Risk Characterization

5. Acute and Chronic Dietary Exposure and Risks for Sensitive

 Subpopulations, Particularly Infants and Children

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

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

8. Cumulative Effects

9. Risk Characterization

C. ENVIRONMENTAL ASSESSMENT

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

2. Environmental Effects Conclusions

 3. Threatened and Endangered Species Assessment

V. ENVIRONMENTAL JUSTICE

VI. RISK MANAGEMENT AND REGISTRATION DECISIONS

A. DETERMINATION OF ELIGIBILITY

B. REGULATORY DECISION

C. LABELING

VII. ACTIONS REQUIRED BY THE REGISTRANT

A. REPORTING OF ADVERSE EFFECTS AND HYPERSENSITIVITY INCIDENTS

VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS

IX. BIBLIOGRAPHY STUDIES SUBMITTED IN SUPPORT OF THIS REGISTRATION

A. STUDIES SUBMITTED IN SUPPORT OF THIS REGISTRATION

B. EPA RISK ASSESSMENT MEMORANDA

APPENDIX-BIOCHEMICAL PESTICIDE DATA REQUIREMENTS
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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

Miachel Rexrode, Ph.D Senior Biologist

Russell Jones, Ph.D Senior Biologist
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I. EXECUTIVE SUMMARY

Laminarin is a naturally occurring polysaccharide carbohydrate (oliggosaccharide) found in all 

edible plants. It is a major constituent in cereal grains, and is consumed as an intentionally

added ingredient in many dietary supplements and texturing agents. Accordingly, it is a regular 

part of the human diet. Laminarin is typically extracted from brown algae, where it is present in 

great quantity as a storage glucan – a carbohydrate food reserve which can be converted to 

glucose when necessary. The extraction results in a low-odor white powder, which is extremely

nutrient rich. Besides being the source for this biochemical pesticide, this algal extract is also a 

regular ingredient in the Japanese diet. As a biochemical active ingredient, Laminarin stimulates 

the natural defense reactions of agricultural crops such as fruiting vegetables, tomato, eggplant, 

pepper, zucchini, cucurbits, watermelon, melons, grape, apple, pear, and strawberries against 

such disease organisms as gray mold, powdery mildew, downy mildew, fire blight, and bacterial 

spot. As a naturally occurring oligosaccharide, residues of the active ingredient are 

undistinguishable from other naturally occurring plant oligosaccharides. In addition to our long 

history of consumption of Laminarin without known toxicological effect, all the information 

submitted to the Agency in conjunction with this exemption from a requirement of tolerance 

confirms that Laminarin is virtually non-toxic and poses no dietary risks to humans. 

Because Laminarin is considered to be “toxicologically innocuous,” no residue studies are 

required to support an exemption from the requirement of a tolerance. Laminarin’s low toxicity

profile notwithstanding, another justification for this exemption from the requirement of a 

tolerance is the unlikelihood of residues for this biochemical pesticide. Laminarin is intended for 

application as a Systemic Acquired Resistance (SAR) inducer – a preventative mode of action. 

As such, it is applied early in a crop’s life cycle – in its growing stages - to help build immunity

to disease organisms such as mold and bacterial infection. And as a biochemical, it biodegrades

rapidly. Data indicate that the active ingredient is more than 65% biodegraded after two weeks 

(MRID 47264954). Calculations indicate that it would be largely biodegraded long before any

final application would be practicable. Accordingly, no significant exposures are expected at the 

time of harvest.

Acute, subchronic and developmental studies submitted in the application for registration 

provided sufficient information to satisfy all mammalian toxicology data requirements. No 

toxicological endpoints were established, and no adverse effects were observed with regard to 

mammalian health. 

No dietary risks are expected with regard to the use of the active ingredient Laminarin. 

Significant dietary exposures (including exposures via drinking water) are not expected for the 

active ingredient Laminarin. In the event of dietary exposure, the toxicological data demonstrate 

that Laminarin is not toxic or pathogenic to mammals. It is a regular constituent of the human 

diet; and there have been no health effects associated with its consumption by people. 

Furthermore, all data demonstrate that no acute, sub-chronic, chronic, immune, or endocrinedisrupting effects are associated with the use of the active ingredient. Accordingly, no harm to 
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infants, children, and the general U.S. population is anticipated with regard to dietary exposure. 

Because of the nontoxic profile and the lack of expected residue of the active ingredient, the 

risks associated with the proposed food uses of this active ingredient are expected to be 

negligible. 

The potential for aggregate, non-occupational exposure is expected to be insignificant as the 

active ingredient is largely biodegraded within two weeks, and applications of Laminarin occur 

early in the growing season. Moreover, given a lack of acute toxicological endpoints and 

because Laminarin is not known to share any structural similarity to any chemicals with common 

mechanisms of toxicity, the likelihood of risks resulting from such de minimus exposures is 

negligible.

Non-target organism and environmental fate data requirements were satisfied through a 

submission of studies. Laminarin occurs naturally in the terrestrial environment, and is not 

associated with any known detrimental effect. All information available to the Agency validates 

a non-toxic mode of action, and a lack of adverse effect relative to non-target organisms. 

In accordance with T-REX Model, the Individual Effects Chance Model Version 1.1 and the 

non-target data submitted, the Agency has made a “No Effect” (NE) determination for direct and 

indirect effects to any listed threatened and endangered species and their habitat as a result of the 

proposed uses of Laminarin.

On October 1, 2009, EPA announced a new policy to provide a more meaningful opportunity for 

the public to participate on major registration decisions before they occur. According to this new 

policy, EPA intends to provide a public comment period prior to making a registration decision 

for, at minimum, the following types of applications: new active ingredients, first food use, first 

outdoor use, and first residential use. 

Consistent with the new policy of making registration actions more transparent, Laminarin is 

subject to a 30 day comment period as a “new active ingredient” whose registration would result 

in a “first outdoor use” and a “first food use.” While a final decision on registration is contingent 

upon review and consideration of public comments, EPA presently believes that based on the 

risk assessment and information submitted in support of the registration of Laminarin that it is in 

the best interests of the public and the environment to issue the registration for Laminarin. The 

basis for this preliminary decision can be found in the risk assessment for Laminarin, which is 

characterized in this BRAD. As discussed above, acute toxicity data for Laminarin indicate a 

nontoxic profile. Laminarin does not demonstrate subchronic or developmental toxicity, and it is 

not mutagenic or genotoxic. EPA has no concerns for any non-target organisms exposed to 

Laminarin in accordance with approved label directions. EPA has not identified any toxic 

endpoints for non-target mammals, birds, plants, aquatic, or soil organisms. Nor are there 

concerns for any threatened and endangered species. Thus, given that Laminarin has very low 

toxicity, and presents little if any risk to non-target organisms, and data confirm its effectiveness 
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as a Systemic Acquired Response (SAR) Inducer, EPA concludes that it is in the best interests of 

the public and the environment to issue the registration for Laminarin. 

EPA reviewed data requirements for granting registration under Section 3(c)(5) of the Federal 

Insecticide, Fungicide and Rodenticide Act (FIFRA). It was preliminarily determined that the 

data/information submitted fulfilled current data requirements (refer to 40 CFR Subpart U § 

158.2000). If the Agency receives comments during the 30 day public comment period that 

inform EPA’s initial decision, EPA will address such new information and take appropriate 

action. 

II. ACTIVE INGREDIENT OVERVIEW

Common Name: Laminarin

Chemical Names: Oligosaccharide, Polysaccharide Carbohydrate, Glucan

Trade & Other Names: Laminarin

CAS Registry Number: 9008-22-4

OPP Chemical Code: 123200

Type of Pesticide: SAR Inducer 

III. REGULATORY BACKGROUND

On July 31, 2008, EPA published in the Federal Register (Volume 74, Number 49) a notice 

announcing that Laboratoires Goemar SA, Z.AC La Madeline, Avenue General Patton, 35400 

Saint-Malo, France c/o SciReg, Inc. 12733 Director's Loop, Woodbridge, VA 22192, submitted 

an application to register a pesticide product (EPA File Symbol 83941-E) containing a new 

active ingredient (Laminarin) not included in any currently registered products. On March 16, 

2009, EPA published in the Federal Register (Volume 74, Number 49) a notice announcing that 

Laboratoires Goemar SA, Z.AC La Madeline, Avenue General Patton, 35400 Saint-Malo, France 

c/o SciReg, Inc. 12733 Director's Loop, Woodbridge, VA 22192, submitted an application 

proposing to establish an exemption from the requirement of a tolerance for residues of the 

biochemical pesticide, Laminarin, in or on all food commodities (PP# 7E7276). No comments 

were received following the publications of either notice.

A. CLASSIFICATION 
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Laminarin is well recognized as a naturally occurring polysaccharide carbohydrate present in 

most plants. With regard to its active properties, it is considered to be a SAR inducer, bolstering 

plant defense mechanisms, protecting plants against attacks from mold, bacteria and fungi. It 

does not work directly against pests, and is not associated with any toxic mode of action. 

Accordingly, Laminarin is considered to be a biochemical pesticide due to its nontoxic mode of 

action to the target pest, natural occurrence in the environment, and its history of exposure to 

humans and the environment without known toxicity. 

B. FOOD CLEARANCES/TOLERANCES 

This active ingredient is being preliminarily supported for food use. The Agency’s risk 

assessment finds no evidence of dietary risk and supports Pesticide Petition# 7E7276, which 

proposes to establish an exemption from the requirement of a tolerance for residues of the 

biochemical pesticide, Laminarin, in or on all food commodities 

IV. RISK 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 (72 FR 61002). The rule became effective 

on December 26, 2007. The data and information evaluated for this Biopesticides Registration 

Action Document (BRAD) were considered in light of these requirements.

The classifications that are found for each data submission are assigned by EPA science 

reviewers and are an indication of the usefulness of the information contained in the documents 

for risk assessment. A rating of “ACCEPTABLE” indicates the study is scientifically sound and 

is useful for risk assessment. A “SUPPLEMENTAL” rating indicates the data provide some 

information that can be useful for risk assessment. The studies may have certain aspects 

determined not to be scientifically acceptable (“SUPPLEMENTAL: UPGRADABLE”). If a 

study is rated as “SUPPLEMENTAL: UPGRADABLE,” the Environmental Protection Agency

always provides an indication of what is lacking or what can be provided to change the rating to 

“ACCEPTABLE.” If there is simply a “SUPPLEMENTAL” rating, the reviewer will often state 

that the study is not required by the current 40 CFR Part 158. Both “ACCEPTABLE” and 

“SUPPLEMENTAL” studies may be used in the risk assessment process as appropriate. An 

“UNACCEPTABLE” rating indicates that new data need to be submitted.

For the acute toxicity data requirements, toxicity categories are assigned for providing the 

appropriate precautionary labeling statement, based on the hazard(s) identified from studies 

and/or other information submitted to the Agency in support of a pesticide registration. The 

active ingredient or particular product is classified into Toxicity Category I, II, III, or IV, where 

Toxicity Category I indicates the highest toxicity and Toxicity Category IV indicates the lowest 

toxicity. 
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A. PRODUCT ANALYSIS ASESSMENT

1. Product Chemistry and Composition

Laminarin is a naturally occurring oligosaccharide that can be found in most plants. It serves 

plants as a storage glucan – a carbohydrate food reserve, which breaks down into glucose and 

provides plants energy in times of stress. Laminarin extract is derived from brown algae 

(Laminara digitata), and is a low-odor white powder. Because of its nutrient richness and 

starchy character, Laminarin extract is commonly used as a dietary supplement, a food texturing 

agent and an ingredient in some ethnic cuisines. 

All product chemistry data requirements for Laminarin have been satisfied. As an active 

ingredient, Laminarin extract is indistinguishable from the oligosaccharide that is produced 

naturally in pants. The extract has a high degree of purity and contains no impurities of 

toxicological significance. All data requirements for physical and chemical characteristics have 

been adequately addressed. 

2. Analysis and Certification of Limits

The submitted data satisfied the requirement for Analysis and Certification of Limits. Five batch 

analyses and the analytical method used to determine the purity of Laminarin were examined and 

determined to be acceptable by the Agency. The certified limits for the active and inert 

ingredients fall within the ranges specified by OPPTS Guideline 830-1750. 

3. Physical and Chemical Characteristics

The Agency has determined that the submitted data adequately describe the physical and 

chemical characteristics of Laminarin. Refer to Table 1 in Appendix A for The Series 830 

physical and chemical properties. 

B. HUMAN HEALTH ASSESSMENT

1. Toxicological Hazard Assessment 

Adequate mammalian toxicology studies were provided in support of the registration of 

Laminarin for each data requirement. Acute toxicology data for Laminarin indicates that the 

active ingredient is virtually non-toxic to mammals, and that there are no toxicological endpoints 

relative to the use of Lamanarin as a SAR inducer. Accordingly, the data submitted demonstrate 

that the proposed uses of Laminarin 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. 
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Refer to Table 2 in Appendix A for a summary of the Toxicity Data Requirements for this food 

use active ingredient.

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

Acute Oral Toxicity – Rat [OPPTS Guideline 870.1100; Master Record Identification (MRID) 

Numbers (Nos.) 47264930 and 47264943]: An acute oral toxicity study shows that the active 

ingredient Laminarin has an LD50 of greater than 2000 mg/Kg in rats. This was the maximum 

dose rate. There were no observed toxicological effects on the test subjects at the maximum 

dose. The study supports the finding that this active ingredient poses no significant human 

health risk with regard to food uses. The study was found “ACCEPTABLE” and Laminarin was 

classified as TOXICITY CATEGORY III for this route of exposure when used as a SAR 

inducer. 

Acute Dermal Toxicity– Rabbits (OPPTS Guideline 870.1200; MRID Nos. 47264931 and 

47264974): An acute oral toxicity study shows that the active ingredient Laminarin has an LD50

of greater than 5000 mg/Kg in rats, which is considered to be virtually non-toxic. Data 

substantiate the active ingredient’s relative dermal non-toxicity to both occupational users and 

the general public. The study was found “ACCEPTABLE” and Laminarin was classified as 

TOXICITY CATEGORY IV for this route of exposure when used as a SAR inducer.

Acute Inhalation Toxicity (OPPTS Guideline 870.1300; MRID Number (No.). 47264932): An 

acute oral inhalation study shows that the active ingredient Laminarin has an LC50 of greater than 

1.02 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 Laminarin was classified as TOXICITY CATEGORY III for this route of 

exposure when used as a SAR inducer. 

Primary Eye Irritation (OPPTS Guideline 870.2400; MRID Nos. 47264933 and 47264976): A 

primary eye irritation study on rabbits demonstrated Laminarin to be non-irritating. There were 

no observed effects for this route of exposure relative to the use of Laminarin. The study was 

found “ACCEPTABLE” and Laminarin was classified as TOXICITY CATEGORY IV for this 

route of exposure when used as a SAR inducer. 

Primary Dermal Irritation (OPPTS Guideline 870.2500; MRID No. 47264934): A skin irritation 

study on rabbits demonstrated that Laminarin was not irritating to the skin. The findings are 

consistent with the other dermal studies and confirm that Laminarin is not toxic through this 

route of exposure. The study was found “ACCEPTABLE” and Laminarin was classified as 

TOXICITY CATEGORY IV for this route of exposure when used as a SAR inducer.

Skin Sensitization (OPPTS Guideline 870.2600; MRID Nos. 47264935 and 47264978): Data 

indicate Laminarin is not a dermal sensitizer. However, any reported incidents may cause this 

position to be reconsidered. 
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Subchronic Testing (OPPTS Guideline 870.3100, 870.3250, 870.3465; MRID Nos. 47264937, 

47264938 and 47264939): In accordance with footnote seven and eight in the Biochemical 

Pesticides Human Health Assessment Data Requirements table in 40 CFR § 158.2050, 

subchronic dermal and subchronic inhalation testing were not required for a lack of exposure. 

Three subchronic oral tests were submitted in support of Laminarin’s food use. These studies 

satisfy the data requirement for subchronic oral testing and indicate that Laminarin has no 

subchronic toxicological effect through the oral route of exposure. A 28-day oral toxicity study

found no toxicological effects regarding mortality, clinical observations, neurotoxicity

assessment, body weight, food consumption, hematology, clinical chemistry, organ weights, and 

macroscopic or microscopic observations. The NOEL was determined to be 1,000 mg/kg/day. A 

90-day oral toxicity study found no statistical difference in hematology, clinical chemistry, or 

urinalysis between test subjects and the control. The NOEL was determined to be 1,000 

mg/kg/day. Another 90-day oral toxicity study also found no statistical difference in 

hematology, clinical chemistry, or urinalysis between test subjects and the control. And the 

NOEL was again determined to be 1,000 mg/kg/day. All subchronic oral toxicity studies 

indicate that Laminarin is not subchronically toxic through the oral route of exposure.

Developmental Toxicity (OPPTS Guideline 870.3700; MRID Nos. 47264940 and 47264941): 

Data submitted to the Agency satisfy the data requirement and support the Agency’s conclusion 

that there is no risk of developmental toxicity associated with the new food uses. A prenatal 

developmental toxicity study on rats found no significant reproductive effects or fetal 

abnormalities, and established a NOAEL of 1,000 mg/kg/day. The findings suggest negligible 

risk with regard to developmental toxicity.

Mutagenicity Testing (OPPTS Guidelines 870.5100, 870.5300, 870.5375; MRID Nos. 47264942, 

4726493 and 47264944): Three genotoxicity studies (a Bacterial Reverse Mutation Test, and an 

In Vitro Mammalian Cells in Culture Assay) were performed on the active ingredient Laminarin 

and satisfy the data requirement. The Reverse Mutation Assay showed that the Laminarin did 

not induce mutant colonies over expected background levels. The In Vitro Mammalian Cells in 

Culture Assay demonstrated that Laminarin did not damage to chromosomes or the mitotic 

apparatus of bone marrow cells. These mutagenicity studies are sufficient to confirm that there 

are no expected dietary, occupational, or non-occupational risks of mutagenicity with regard to 

Laminarin.

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

The Tier II studies listed below were the only higher Tier studies required for Laminarin. No 

other studies were required based on a lack of acute toxicity in the Tier I studies and a lack of 

exposure relative to its use pattern as a SAR inducer

Developmental Toxicity (OPPTS Guideline 870.3700; MRID No. 47264941): Tier II data are 

required on the active ingredient for developmental toxicity if there might be regular exposure to 
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women. In that case, a second prenatal study using a different test subject is required. A second 

prenatal developmental toxicity study on rabbits also found no significant treatment-related 

reproductive effects or fetal abnormalities, and confirmed a NOAEL of 1,000 mg/kg/day. Data 

submitted to the Agency confirm that Laminarin poses negligible risk with regard to 

developmental toxicity.

Mutagenicity Testing (OPPTS Guidelines 870.5385; MRID No. 47264944): Tier II data are 

required on the active ingredient for mutagenicity testing for the active ingredient. A bone 

Marrow Micronucleus Assay indicated that no toxicity was noted in either sex at any dose up to 

the limit dose of 2000 mg/kg. This mutagenicity study, in conjunction with the Tier I 

mutagenicity studies, satisfies the data requirement for mutagenicity testing and is sufficient to 

confirm that there are no expected dietary, occupational, or non-occupational risks of 

mutagenicity with regard to Laminarin.

Immunotoxicity Testing (OPPTS Guidelines 880.3550; MRID No. 47264945): A waiver request 

was accepted for immunotoxicity for the following reasons: 1) The potential for any 

immunotoxic effect is precluded by the Laminarin’s biodegradability. 2) Laminarin is not 

structurally related to any known immunotoxic chemical. 3) There is a long history of the 

consumption of Laminarin without known immunotoxicological incident. 4) The toxicological 

profile in acute toxicological studies, subchronic studies and developmental studies does not 

suggest any immunotoxicity. All information points to the lack of dietary risk posed by the 

immunotoxicity of Laminarin residues, and supports the exemption from the requirement of a 

tolerance.

c. Effects on the Endocrine System

EPA will issue test orders between today and February 2010. The schedule for issuance of test 

orders, and details regarding status will be available at http://www.epa.gov/endo/. EPA has also 

established a docket for the test orders in www.regulations.gov under docket number EPA-HQOPP-2009-0634. 

Data required under the test orders will provide information to help EPA identify whether 

chemicals have the potential to interact with the estrogen, androgen, and/or thyroid hormone 

systems, which regulate growth, metabolism, development, and reproduction. The data 

generated from the screens will provide robust and systematic scientific information that will 

help EPA identify whether additional testing is necessary.

Laminarin is a naturally occurring carbohydrate present in our fruits and vegetables. To date, 

there is no evidence to suggest that our natural exposure to Laminarin affects the immune 

system, functions in a manner similar to any known hormone, or that it acts as an endocrine 

disruptor. Moreover, the use of Laminarin is not expected to result in any significant exposures, 

effectively obviating any opportunity for negative effects on humans or the environment. 

Therefore, it is unlikely that Laminarin will have estrogenic or endocrine effects.
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Because there is no available evidence demonstrating that Laminarin is an endocrine disruptor, 

the Agency is not requiring information on the endocrine effects of Laminarin at this time.

However, the Endocrine Disruption Screening Program (EDSP) has established a protocol, 

which guides the Agency in selecting suspect ingredients for review; and the Agency reserves 

the right to require new information, should the program require it. Presently, based on the lack 

of exposure and the negligible toxicity profile of the extract, no adverse effects to the endocrine 

or immune systems are known or expected. 

2. Dose Response Assessment 

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

required. 

3. Dietary Exposure and Risk Characterization

Exposure to residues of Laminarin on foods is expected to be negligible; and even in the event of 

dietary exposure, no dietary risks are anticipated. Data submitted to the Agency show that 

Laminarin is 65% to 71% biodegraded within two weeks, and that it hydrolyzes very rapidly into 

glucose. Because applications tend to occur earlier in the growing season (due to its mode of 

action as a SAR inducer), and given its short-lived presence on crops, no significant pesticidal 

residues are anticipated for harvested foods. Even in the event of exposure to residues, however,

no dietary risks are anticipated. Acute, subchronic, and teratogenicity studies support its nontoxic profile. It is already present in the human diet – especially in cereal grains - without any

known detrimental effect. Furthermore, it is approved by US FDA as a food additive, a dietary

supplement and a texturing agent in processed foods in quantities greater than any expected 

pesticidal residues. 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 

its nontoxic profile.

4. Drinking Water Exposure Risk Characterization

Residues of Laminarin are not expected to be present in drinking water. Applications of 

Laminarin are made directly to terrestrial crops. These residues biodegrade rapidly, and are not 

expected to percolate through soil. Even in the event of an errant spray drift or an extraordinary

rainfall event, Laminarin does not persist in water due to its rapid hydrolyzation into glucose. 

Moreover, risks from a miniscule aquatic exposure would be negligible, given Laminarin’s 

nontoxic profile. Altogether, drinking water exposure is not expected to pose any quantifiable 

risk due to a lack of residues, and the nontoxicity of Laminarin.

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

Particularly Infants and Children
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Dietary exposure to humans, including infants and children, are considered negligible with 

regard to the pesticidal use of Laminarin. Because Laminarin is mostly biodegraded within two 

weeks and applications of Laminarin tend to occur earlier in the growing season with a minimum 

of ten day intervals between applications, no significant residues of Laminarin are expected on 

foods. Additionally, Laminarin is known to hydrolyze in water relatively rapidly, and so what 

few residues might exist at harvest would be degraded into glucose during processing. In the 

event that there are any residues, acute toxicity studies indicate that Laminarin 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. Its use is approved by FDA as a food additive, 

a dietary supplement and as a texturing agent for processed foods. While no dietary exposures 

are expected, the Agency has determined there is a reasonable certainty of no harm to the general 

US population, including infants and children, from exposure to this active ingredient.

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

Characterization

As an agricultural pesticide, some occupational exposure to Laminarin can reasonably be 

expected. Such occupational exposures are expected to be insignificant because - by virtue of 

Laminarin’s mode of action as A SAR inducer - applications are directed and infrequent. The 

insignificance of any exposure is even more pronounced for residential, school, or daycare areas. 

Even in the event of incidental exposure, health risks to humans, including infants and children, 

are considered negligible, given Laminarin’s nontoxic profile. 

a. Occupational Exposure and Risk Characterization

Occupational exposures are expected to be minimal. As a biochemical with a preventative mode 

of action, applications of Laminarin will tend to be limited to earlier in the growing season when 

it can best bolster plant defenses; and applications are expected to occur at more infrequent 

intervals than most other pesticides, as SAR induction requires time to be actualized in the 

plants. Also, applications are expected to be foliarly directed in order to be most effective, 

further diminishing the chance of spray drift associated with area-wide sprays. Regardless, 

requirements for the use of appropriate personal protective equipment and precautionary

statements are required on product labels to mitigate any potential risks to pesticide handlers due 

to prolonged exposure. But even in the event of occupational exposure, any health risks 

associated with regular exposure seem unlikely. People have regularly consumed Laminarin in 

their fruits and vegetables with no history of detrimental effects. Moreover, Laminarin has been 

approved by FDA as a food additive and for use in ointments, suggesting a lack of risks for both 

the oral and the dermal routes of exposure. And with regard to pesticidal applications, all acute, 

subchronic, and developmental toxicity data submitted in support of this application for 

Laminarin confirm its lack of toxicity through all routes of exposure. Because of a lack of likely 

exposure to residues and a well established nontoxic profile for Laminarin, no occupational risks 

are expected with regard to the use of this active ingredient.
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b. Residential, School, and Daycare Exposure and Risk Characterization

The Agency does not expect any risks to children (or adults) in any of these environments. Due 

to the agricultural use pattern of Laminarin, the potential for significant exposure is negligible. 

Even in the remote event of incidental residue, 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. Directed Laminarin spray is 

not expected to result in significant amounts of respirable mist, and is not anticipated to be in 

non-occupational environments at all. Likewise directed foliar applications, are not likely to 

result in dermal exposures, especially in non-occupational environments. The chance of 

significant incidental residues, which could be consumed are also slight. 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 Laminarin, 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 Laminarin residues and other substances that have a 

common mechanism of toxicity. These considerations include the potential for cumulative 

effects on infants and children of Laminarin residues and other substances with a common 

mechanism of toxicity. Because Laminarin has a long history of dietary consumption without 

incident, and because no toxicological endpoints have been established, the Agency concludes 

that Laminarin does not share a common mechanism of toxicity, and that there are no cumulative 

effects arising from Laminarin residues in or on food commodities.

9. Risk Characterization

The Agency considered human exposure to Laminarin in light of the relevant safety factors in 

FQPA and FIFRA. A preliminary 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 Laminarin when label instructions are followed. 

C. ENVIRONMENTAL ASSESSMENT
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Biopesticide Registration Action Document

1. Ecological Hazards (Relative to the Biochemical Pesticides Nontarget Organisms 

and Environmental Fate Data Requirements - 40 CFR § 158.2060)

Non-target organism and environmental fate data requirements were satisfied through a 

submission of studies. Laminarin is known to occur naturally in the terrestrial and aquatic 

environment, and is not associated with any known detrimental effect. All information available 

to the Agency validates a non-toxic mode of action, a lack of persistence in the environment, and 

a lack of adverse effect relative to non-target organisms. 

In accordance with T-REX Model and the non-target data submitted, the Agency has made a “No 

Effect” (NE) determination for direct and indirect effects to any listed threatened and endangered 

species and their habitat as a result of the proposed uses of Laminarin.

Avian Testing (OPPTS Guidelines 850.2100, 850.2200; MRID Nos. 47264950 and 47264951): 

No avian toxicity is expected with regard to the pesticidal use of Laminarin. In an acute oral 

toxicity study, groups of bobwhites were administered single oral doses ranging up to 2000 

mg/kg body weight Laminarin. They were observed for 14 days. There were no mortalities and 

no signs of adverse effects - all birds appeared healthy during the test, and macroscopic 

examination revealed no abnormalities in any birds. The acute oral LD50 was >2000 mg/kg, the 

highest dose tested. In a dietary toxicity study on bobwhites, groups of chicks were provided a 

Laminarin-dosed diet for 5 days, at concentrations ranging up to 5000 ppm per feeding. The diet 

was maintained for 5 days. There were no treatment-related effects on mortality, body weight, or 

feed consumption, and no clinical signs of toxicity. The dietary LD50 was determined to be

>5000 ppm. The exposure calculation suggests that even if a bird consumed an entire acre of the 

active ingredient, a toxic threshold would not occur. A lack of toxicological endpoints indicates

that Laminarin is nontoxic to birds.

Aquatic Organism Testing (OPPTS Guidelines 850.1010, 850.1075, 850.5400; MRID Nos.

47264947, 47264948, 47264949, and 47264953): No risks are expected with regard to the 

exposure of aquatic organisms to Laminarin. Aquatic exposure is unlikely due to the rapid 

biodegradation and hydrolysis of Laminarin. But in the event of aquatic exposures, no hazards 

are expected for aquatic organisms. In an acute toxicity test, groups of Daphnia magna were 

exposed to concentrations of Laminarin up to 100 mg/L Laminarin. No daphnid mortality or 

immobility was seen in any of the test groups after 24 or 48 hours. In this study, the 48-hr NOEC 

and EC0 were each ≥100 mg/L, and the LOEC and EC50 were >100 mg/L. In an acute toxicity

test, groups of zebrafish were exposed to a nominal concentration of 0 or 100 mg/L Laminarin 

for 96 hours. No mortality or adverse clinical signs were seen at any intervals or in any of the test 

groups. The 96-hr LC50 for Laminarin in Zebra Fish was >100 mg/L. In a second toxicity test, 

groups of Rainbow Trout fry were exposed to a nominal concentration of 0 or 100 mg/L 

Laminarin for 96 hours. No mortality or adverse clinical signs were seen in any of the test 

groups. The 96-hr LC50 for Laminarin in Rainbow Trout was >100 mg/L. A 72-hour laboratory

study was conducted to determine the effects of Laminarin (100 mg/L, nominal) on the growth of 
Laminarin Page 16 

Biopesticide Registration Action Document

the unicellular freshwater green algae. An untreated control was also included in the test. At test 

end, cell growth and density were similar in the test material and control group. The 72-hour 

EbC50 and ErC50 for H11 were >100 mg/L, and the NOECb and NOECr were >100 mg/L. The 4 

studies altogether confirm a lack of toxicological endpoints, and indicate that Laminarin is 

nontoxic to aquatic organisms 

Non-Target Plant Testing (OPPTS Guidelines 850.4100, 850.4150): The data requirement was 

satisfied by information demonstrating a lack of hazard to non-target plants relative to the active 

ingredient’s mode of action. The active ingredient is to be directed at agricultural crops; 

incidental residues would be negligible. To the degree that there is incidental exposure, 

Laminarin has been shown to have a non-toxic mode of action relative to plants. As a SAR 

inducer, Laminarin bolsters plant health. Accordingly, Laminarin would actually be expected to 

have a strengthening effect on non-target plants. 

Non-Target Insect Testing (OPPTS Guideline 880.4350, 850.3020); MRID Nos. 47264979 and 

47264952): Data indicate that the residues of Laminarin pose no risks of toxicity to non-target 

insects. In a laboratory study, groups of male and female adult parasitic wasps were exposed for 

48 hours to 37 g/L Laminarin sprayed on glass plates at varying rates up to10.0 L/ha. Some 

issues of loss of fecundity were observed at the highest dose; but none were observed at the 

doses that were in line with the expected applications of the active ingredient. (The dose at 

which there was a loss of fecundity was 10x greater than expected residues of Laminarin at the 

time of pesticidal application.) There was no statistically significant difference in mortality 

between the treated wasps and the untreated control groups. Limit tests were conducted to 

determine the acute oral and acute contact toxicity of Laminarin to the Honey Bee. Both tests 

used a nominal dose of 100.00 μg Laminarin/bee. In the oral toxicity test, groups of caged bees 

were provided the test material in a 50% w/v sucrose solution for six hours, and then monitored 

for mortality at intervals up to 48 hours. After 48 hours, there was no difference in mortality of 

the untreated control and test material groups. In the contact toxicity test, bees were anesthetized 

with carbon dioxide and received an individual application of Laminarin to the ventral thorax. In 

this test, the 48-hr oral toxicity LD50 for Laminarin was >118.64 μg/bee, and the 48-hr contact 

toxicity LD50 was >100.00 μg/bee. Data indicate that exposures to Laminarin are not expected to 

result in any adverse effects to non-target insects. 

2. Environmental Fate and Ground Water Data

The need for environmental fate and groundwater data was not triggered because results of the 

acute toxicity assessment did not trigger any additional Tier I studies.

3. Ecological Exposure and Risk Characterization

The use of Laminarin is not expected to result in significant ecological exposures; and to the 

degree that there are any incidental exposures, all data on file with the Agency demonstrate that 

Laminarin is nontoxic to non-target organisms. Laminarin is intended to be applied directly to 
Laminarin Page 17 

Biopesticide Registration Action Document

crops early in the growing season at bi-monthly intervals. Biodegradability data show that it 

does not persist, and that it hydrolyzes rapidly. (Laminarin is 65-71% biodegraded within two 

weeks.) When used according to the proposed label directions, no direct exposures are expected 

for non-target organisms. Laminarin is a naturally occurring carbohydrate. Its presence in the 

environment has no known toxicological effect on animals or plants. Data submitted to satisfy

the non-target organism data requirements confirm Laminarin’s lack of ecotoxicity. No adverse 

effects were observed on plants, insects, mammals, avian species and aquatic organisms; and no 

toxicological endpoints were identified for any of these organisms. No risks are expected to the 

environment with regard to the pesticidal use of Laminarin.

4. Threatened and Endangered Species Assessment

Based on the available data, a No Effects (NE) determination was made for Laminarin on 

threatened and endangered species when Laminarin is applied to crops as a SAR inducer. The 

Agency notes that all non-target organism data indicate no toxicity to non-target organisms. 

Laminarin has a non-toxic mode of action, which precludes toxic effects on plants. And 

Laminarin is intended to be applied as an agricultural product; accordingly exposures to 

threatened and endangered species are expected to be negligible. The Agency used its T-REX 

Model and its Individual Effects Chance Model Version 1.1, in conjunction with data submitted 

on non-target organisms to quantifiably estimate the chance of risk to endangered/threatened 

avian and aquatic species from exposure to Laminarin. These values (avian risk at 1 in 294,000 

and aquatic risk at 1 in 418,000,000) suggest that Laminarin should not cause toxic risk to 

endangered/threatened species. The calculated RQ values for endangered/threatened terrestrial 

(RQ = 0.00) and aquatic species (RQ = 0.0045) are below the Agency’s LOCs of 0.1 and 0.5, 

respectively, supporting the Agency’s finding that exposure to Laminarin will have No Effect 

(NE) on threatened and endangered species.

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 Laminarin, 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

A. Determination of Eligibility
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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 Laminarin. 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, Laminarin is eligible for registration for the 

labeled uses.

B. Regulatory Decision

On October 1, 2009, EPA announced a new policy to provide a more meaningful opportunity for 

the public to participate on major registration decisions before they occur. According to this new 

policy, EPA intends to provide a public comment period prior to making a registration decision 

for, at minimum, the following types of applications: new active ingredients; first food use; first 

outdoor use; and first residential use. Accordingly, this pesticide is subject to a 30-day comment 

period as a new active ingredient with both outdoor uses and residential uses. Any regulatory

decision will be informed by the comments EPA receives.

At this time, EPA believes, the data submitted fulfill the requirements of registration for products 

containing Laminarin for use as a SAR inducer. Acute toxicity data for Laminarin demonstrate 

that it is toxicity category III and IV for all routes of exposure. (No toxicological endpoints were 

established.) Data confirm that Laminarin does not demonstrate subchronic or developmental 

toxicity, and it is not mutagenic or genotoxic. EPA has no concerns for any non-target 

organisms exposed to Laminarin in accordance with its approved uses. EPA has not identified 

any toxic endpoints for non-target mammals, birds, plants, aquatic, or soil organisms. Nor are 

there concerns for any threatened and endangered species. Given, the non-toxic character of 

Laminarin, EPA supports its registration under Section 3(c)(5) of the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA). Refer to Appendix B for product-specific information.

1. Conditional/Unconditional Registration

All data requirements are fulfilled and EPA has preliminarily determined that an unconditional 

registration for Laminarin is warranted under Section 3(c)(5) of FIFRA. 

C. Labeling
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Biopesticide Registration Action Document

Before releasing pesticide products containing Laminarin for shipment, the applicant is required 

to provide appropriate labels.

VII. ACTIONS REQUIRED BY THE REGISTRANT

The Agency evaluated the data submitted in connection with the initial registration of Laminarin

and preliminarily determined that these data fulfill current registration guideline requirements. 

No additional data are required to be submitted to the Agency at this time. Additional data may

be required for new uses and/or changes to existing uses. 

Not withstanding the information stated in the previous paragraph, it should be clearly

understood that certain, specific, data are required to be reported to the Agency as a requirement 

for maintaining the Federal registration for a pesticide product. A brief summary of these types 

of data are listed below. 

A. Reporting of Adverse Effects and Hypersensitivity Incidents

Reports of all incidents of adverse effects to the environment must be submitted to the Agency

under the provisions stated in FIFRA, Section 6(a)(2).

Additionally, all incidents of hypersensitivity (including both suspected and confirmed incidents) 

must be reported to the Agency under the provisions of 40 CFR Part 158.2140 OPPTS Guideline 

reference number 885.3400.
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Biopesticide Registration Action Document

VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS

BPPD Biopesticides and Pollution Prevention Division

BRAD Biopesticide Registration Action Document

CFR Code of Federal Regulations

cm3cubic centimeter

CSF Confidential Statement of Formula

°C degrees Celsius

EDSP Endocrine Disruptor Screening Program

EDSTAC Endocrine Disruptor Screening and Testing Advisory Committee

EPA Environmental Protection Agency (the “Agency”)

FFDCA Federal Food, Drug, and Cosmetic Act

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FQPA Food Quality Protection Act

FR Federal Register

g gram

kg kilogram

L liter

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

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

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

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

MRID No. Master Record Identification Number

mg milligram

mL milliliter

MP manufacturing-use product

MPCA microbial pest control agent

NE “No Effect”

NIOSH National Institute for Occupational Safety and Health

OPP Office of Pesticide Programs

OPPTS Office of Prevention, Pesticides, and Toxic Substances

PCR polymerase chain reaction 

PPE personal protective equipment

TGAI technical grade of the active ingredient
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Biopesticide Registration Action Document

IX. BIBLIOGRAPHY STUDIES SUBMITTED IN SUPPORT OF THIS REGISTRATION

A. Studies Submitted in Support of this Registration.

MRID Citation Receipt 

Date

47264900

Laboratoires Goemar S.A. (2007) Submission of Efficacy, Toxicity and Product 

Chemistry Data in Support of the Application for Registration of Vacciplant. 

Transmittal of 78 Studies.

24-Oct2007

47264901

Smith, F. (2007) Product Identity and Composition, Description of Beginning 

Material, Manufacturing Process, and Discussion of Formation of Impurities: 

(Vacciplant). Unpublished study prepared by SciReg, Inc. 18 p.

24-Oct2007

47264902

Trebert, R. (2001) Laminarin - Analytical Profiles of Batches: (Final Report). 

Project Number: BPL/200007/0395. Unpublished study prepared by Crepin 

Analyses & Controles. 84 p.

24-Oct2007

47264904 Cruz, F. (1998) Determination of Pure Laminarin: Global Method. Project Number: 

FC98005. Unpublished study prepared by Laboratories GOEMAR. 8 p.

24-Oct2007

47264905

Trebert, R.; Cousin, C. (2002) Validation of the Method of the Dosage of Pure 

Laminarin: Global Method: (Final Report). Project Number: BPL/200107/1309. 

Unpublished study prepared by Crepin Analyses & Controles. 27 p.

24-Oct2007

47264906 Delolme, F. (2007) Analysis by MALDI-TOF Mass Spectrometry. Project Number: 

FC000828. Unpublished study prepared by SciReg, Inc. 7 p.

24-Oct2007

47264907

Smith, F. (2007) Summary of the OPPTS 830 Series Physical-Chemical 

Properties Test Guidelines: (Vacciplant). Unpublished study prepared by SciReg, 

Inc. 15 p.

24-Oct2007

47264908 Smith, F. (2007) Color, Odor, Physical State: (Vacciplant). Unpublished study 

prepared by SciReg, Inc. 4 p.

24-Oct2007

47264909

Trebert, R. (2002) G.L.P. Stability Study on Laminarin Code H 11 Batch N 

S012000 According to EPA 830.6313: Final Report. Project Number: 

BPL/200112/0368. Unpublished study prepared by Crepin Analyses & Controles. 

31 p.

24-Oct2007

47264910 Cuthbert, J. (2001) Laminarin: Determination of Spectra. Project Number: 

1476/001VM. Unpublished study prepared by Safepharm Laboratories, Ltd. 24 p.

24-Oct2007

47264911 Luc, L. (2000) Laminarin-Oxidizing Properties. Project Number: 00/907005/020. 

Unpublished study prepared by SEPC. 23 p.

24-Oct2007

47264912 Luc, L. (2007) Laminarin- Flammability of Solids. Project Number: 00/907005/016. 

Unpublished study prepared by SEPC. 18 p.

24-Oct2007

47264913 Luc, L. (2000) Laminarin-Self-Ignition Temperature of Solids. Project Number: 

00/907005/019. Unpublished study prepared by SEPC. 17 p.

24-Oct2007

47264914 Luc, L. (2000) Laminarin-Flammability in Contact with Water. Project Number: 24-Oct-
Laminarin Page 22 

Biopesticide Registration Action Document

00/907005/017. Unpublished study prepared by SEPC. 18 p. 2007

47264915 Luc, L. (2000) Laminarin-Explosive Properties (Solid). Project Number: 

00/907005/018. Unpublished study prepared by SEPC. 25 p.

24-Oct2007

47264916 Luc, L. (2000) Laminarin-Melting Point. Project Number: 00/907005/003. 

Unpublished study prepared by SEPC. 18 p.

24-Oct2007

47264917 Luc, L. (2000) Laminarin - Relative Density. Project Number: 00/907005/005. 

Unpublished study prepared by SEPC. 21 p.

24-Oct2007

47264918 Claude, A. (2002) Laminarin-Relative Density. Project Number: 01/907005/002. 

Unpublished study prepared by SEPC. 21 p.

24-Oct2007

47264919 Luc, L. (2002) Laminarin - Soulubility in Water. Project Number: 00/907005/008. 

Unpublished study prepared by SEPC. 43 p.

24-Oct2007

47264920 Martel, I. (2002) Determination of pH Values - (Laminarin). Project Number: 

01/907005/001. Unpublished study prepared by SEPC. 17 p.

24-Oct2007

47264921 Luc, L. (2001) Laminarin-Solubility in n-Heptane. Project Number: 00/907005/09, 

SEP/00/068. Unpublished study prepared by SEPC. 41 p.

24-Oct2007

47264922 Luc, L. (2001) Laminarin - Solubility in Xylene. Project Number: 00/907005/010, 

SEP/00/069. Unpublished study prepared by SEPC. 41 p.

24-Oct2007

47264923 Luc, L. (2001) Laminarin-Solubility in 1,2 Dichloroethane. Project Number: 

00/907005/011, SEP/00/070. Unpublished study prepared by SEPC. 41 p.

24-Oct2007

47264924 Luc, L. (2001) Laminarin-Solubility in Methanol. Project Number: 00/907005/012, 

SEP/00/071. Unpublished study prepared by SEPC. 41 p.

24-Oct2007

47264925 Luc, L. (2001) Laminarin-Solubility in Acetone. Project Number: 00/907005/013, 

SEP/00/072. Unpublished study prepared by SEPC. 41 p.

24-Oct2007

47264926 Luc, L. (2001) Laminarin-Solubility in Ethyl Acetate. Project Number: 

00/907005/014, SEP/00/073. Unpublished study prepared by SEPC. 41 p.

24-Oct2007

47264927

Tremain, S. (2001) Laminarin: Determination of Vapour Pressure. Project 

Number: 1303/005. Unpublished study prepared by Safepharm Laboratories, Ltd. 

and SEPC. 21 p.

24-Oct2007

47264928

Quintelas, G. (2001) Determination of the Partition Coefficient of Laminarin. 

Project Number: SEP/00/074, 00/907005/015. Unpublished study prepared by 

Defitraces. 25 p.

24-Oct2007

47264929 Luc, L. (2000) Laminarin-Surface Tension. Project Number: 00/907005/007. 

Unpublished study prepared by SEPC. 19 p.

24-Oct2007

47264930

Baudet, L. (2002) Phycarine 96S51: Acute Toxicity Study Safety Test in the Rat 

by the Oral Route. Project Number: 20010618/ST. Unpublished study prepared by 

Centre de Recherches Biologiques. 27 p.

24-Oct2007

47264931 Audeval Gerald, C. (2001) H11 (Batch 99S24) Acute Dermal Toxicity Study in the 24-Oct-
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Biopesticide Registration Action Document

Rat. Project Number: 20000698/ST, 20000698/ST/TAUVD/H11. Unpublished 

study prepared by Centre de Recherches Biologiques. 30 p.

2007

47264932

Muller, W. (1999) Evaluation of Acute Inhalation Toxicity with Phycarine in Rats. 

Project Number: 980001/EX, TOXLABS/1998/7019/INH. Unpublished study 

prepared by Centre de Recherches Biologiques. 19 p.

24-Oct2007

47264933

Baudet, L. (2002) Phycarine 96S51: Ocular Primary Irritation in the Rabbit. Project 

Number: 20010615/ST. Unpublished study prepared by Centre de Recherches 

Biologiques. 27 p.

24-Oct2007

47264934

Baudet, L. (2002) Phycarine 96S51: Cutaneous Primary Irritation in the Rabbit: 

Final Report. Project Number: 20010617/ST/PSI/RABBIT/PHYCARIINE. 

Unpublished study prepared by Centre de Recherches Biologiques. 25 p.

24-Oct2007

47264935

Baudet, L. (2002) Phycarine 96S51: Study of Cutaneous Sensitization Using the 

Magnusson and Kligman Maximisation Test in the Guinea Pig: Final Report. 

Project Number: 20010616/ST. Unpublished study prepared by Centre de 

Recherches Biologiques. 39 p.

24-Oct2007

47264936

Delille, M. (1998) Acute Toxicity Study: Safety Test in the Rat by the 

Subcutaneous Route: (Phycarine 96S51). Project Number: 970353/ST. 

Unpublished study prepared by Centre de Recherches Biologiques. 24 p.

24-Oct2007

47264937

Longobardi, C. (2000) 4489-1 (product H 11): 4 Week Oral Toxicity Study in Rats: 

Final Report. Project Number: 7286, 7286/T/240/99. Unpublished study prepared 

by Research Toxicology Centre, S.p.A.. 178 p.

24-Oct2007

47264938

Audeval Gerard, C. (2001) H11 (Batch 99S24): 90-Day Repeated Dose Oral 

Toxicity Study in the Rat. Project Number: 20000389/T. Unpublished study 

prepared by Centre de Recherches Biologiques. 237 p.

24-Oct2007

47264939

Audeval Gerard, C. (2001) 90-Day Repeated Dose Oral Toxicity Study in the Dog. 

Project Number: 20000390/T. Unpublished study prepared by Centre de 

Recherches Biologiques. 257 p.

24-Oct2007

47264940

Audeval Gerard, C. (2001) H11 (Batch 99S24): Study for the Effects on EmbryoFoetal Development in the Rat by the Oral Route. Project Number: 20000387/T. 

Unpublished study prepared by Centre de Recherches Biologiques. 127 p.

24-Oct2007

47264941

Gerard, C. (2001) Study for the Effects on Embryo-Foetal Development in the 

Rabbit by the Oral Route: H11 (Batch 99S24). Project Number: NO/20000388/T. 

Unpublished study prepared by CERB (Centre de Recherches Biologiques). 127 

p.

24-Oct2007

47264942

Marzin, D. (2000) Mutagenicity Test on Bacteria (Salmonella typhimurium his and 

Escherichia coli trp) Using B.N. Ames's Technique with H11. Project Number: 

IPL/R/991011/H11/GOEMAR/LABORATORY. Unpublished study prepared by 

Institut Pasteur de Lille. 38 p.

24-Oct2007

47264943

Haddouk, H. (2002) In Vitro Mammalian Cell Gene Mutation Test in L5178Y TK 

Mouse Lymphoma Cells: Laminarin. Project Number: 22626/MLY. Unpublished 

study prepared by Centre International de Toxicologie. 47 p.

24-Oct2007
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Biopesticide Registration Action Document

47264944

Haddouk, H. (2001) Bone Marrow Micronucleus Test by Oral Route in Mice: 

Laminarin. Project Number: 21149/MAS, 

21149/MAS/LAMINARIN/LABORATOIRES/GOEMAR/SA. Unpublished study 

prepared by Centre International de Toxicologie. 37 p.

24-Oct2007

47264945 Smith, F. (2007) Toxicology Waiver Request - Immunotoxicity (Laminarin). 

Unpublished study prepared by SciReg, Inc. 11 p.

24-Oct2007

47264946

Quintelas, G. (2001) Abiotic Degradation of Laminarin pH Dependent Hydrolysis 

(Test C7). Project Number: SEP/00/075, SEPC/00/907005/025, 00/907005/025. 

Unpublished study prepared by Defitraces. 30 p.

24-Oct2007

47264947

Herti, J. (2001) Acute Toxicity of Laminarin to Daphnia magna in a 48-Hour SemiStatic Immobilization Test: Final Report. Project Number: PROJECT/10041220. 

Unpublished study prepared by Institut fuer Biologische Analytik und Consulting 

IBACON. 61 p.

24-Oct2007

47264948

Luc, L. (2001) Acute Toxicity in Freshwater Fish (96h): Oncorhynchus mykiss 

(Laminarin). Project Number: 00/907005/021. Unpublished study prepared by 

SEPC. 50 p.

24-Oct2007

47264949 Luc, L. (2001) Acute Toxicity in Freshwater Fish (96h): Danio rerio: (Laminarin). 

Project Number: 00/907005/022. Unpublished study prepared by SEPC. 49 p.

24-Oct2007

47264950

Rodgers, M. (2002) Laminarin: Acute Oral Toxicity (LD50) to the Bobwhite Quail. 

Project Number: GOM/001, GOM/001/022173. Unpublished study prepared by 

Huntingdon Life Sciences, Ltd. 23 p.

24-Oct2007

47264951

Rodgers, M. (2002) Laminarin: Dietary Toxicity (LC50) to the Bobwhite Quail. 

Project Number: GOM/002, GOM/002/014410. Unpublished study prepared by 

Huntingdon Life Sciences, Ltd. 21 p.

24-Oct2007

47264952

Kling, A. (2000) Assessment of Side Effects of Laminarin to the Honey Bee, Apis 

mellifera L. in the Laboratory: Final Report. Project Number: 20001342/01/BLEU. 

Unpublished study prepared by Arbeitsgemeinschaft GAB Biotechnologie. 33 p.

24-Oct2007

47264953

Gnemi, P. (2000) H11: Algal Growth Inhibition Study. Project Number: 990714. 

Unpublished study prepared by Istituto di Ricerche Biomediche Antoine Marxer 

RBM S.p.A. 27 p.

24-Oct2007

47264954 Luc, L. (2000) Ready Biodegradability Modified Strum Test: (Laminarin). Project 

Number: 00/907005/024. Unpublished study prepared by SEPC. 24 p.

24-Oct2007

47264955

Smith, F. (2007) Product Identity and Composition, Description of Beginning 

Materials, Description of Formulation Process, Discussion of Formation of 

Impurities, and Certified Limits (Vacciplant). Unpublished study prepared by 

SciReg, Inc. 57 p.

24-Oct2007

47264956

Smith, F. (2007) Summary of the OPPTS 830 Series Physical-Chemical 

Properties Test Guidelines (Vacciplant). Unpublished study prepared by SciReg, 

Inc. 6 p.

24-Oct2007

47264957 Luc, L. (2001) Phyliq: Determination of pH Value of the Test Item . Project 

Number: 00/907005/026. Unpublished study prepared by SEPC. 17 p.

24-Oct2007
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Biopesticide Registration Action Document

47264958 Luc, L. (2001) Phyliq: Determination of pH Value of a 1% Aqueous Dilution. 

Project Number: 00/907005/028. Unpublished study prepared by SEPC. 17 p.

24-Oct2007

47264959

Luc, L. (2001) Phyliq: Determination of pH Value of the Test Item After an 

Accelerated Storage Procedure at + 54 Degrees Celsius for 14 Days. Project 

Number: 00/907005/035. Unpublished study prepared by SEPC. 17 p.

24-Oct2007

47264960

Luc, L. (2001) Phyliq: Determination of pH Value of a 1% Aqueous Dilution After 

an Accelerated Storage Procedure at + 54 Degrees Celsius for 14 Days. Project 

Number: 00/907005/037. Unpublished study prepared by SEPC. 17 p.

24-Oct2007

47264961 Luc, L. (2001) Phyliq: Viscosity. Project Number: 00/907005/029. Unpublished 

study prepared by SEPC. 18 p.

24-Oct2007

47264962 Luc, L. (2001) Phyliq: Relative Density. Project Number: 00/907005/030. 

Unpublished study prepared by SEPC. 20 p.

24-Oct2007

47264963

Luc, L. (2001) Phyliq: Storage Stability: Accelerated Procedure by Heating (at +54 

Degrees Celsius for 14 Days). Project Number: 00/907005/034. Unpublished 

study prepared by SEPC. 39 p.

24-Oct2007

47264965 Luc, L. (2001) Phyliq: Low Temperature Stability. Project Number: 

00/907005/040. Unpublished study prepared by SEPC. 18 p.

24-Oct2007

47264966 Luc, L. (2001) Phyliq: Dilution Stability. Project Number: 00/907005/033. 

Unpublished study prepared by SEPC. 18 p.

24-Oct2007

47264967

Luc, L. (2001) Phyliq: Dilution Stability After an Accelerated Storage Procedure at 

+54 (Degrees) Celcius for 14 Days. Project Number: 00/907005/039. Unpublished 

study prepared by SEPC. 18 p.

24-Oct2007

47264968 Luc, L. (2001) Phyliq: Surface Tension. Project Number: 00/907005/031. 

Unpublished study prepared by SEPC. 20 p.

24-Oct2007

47264969 Luc, L. (2001) Phyliq: Persistent Foaming. Project Number: 00/907005/032. 

Unpublished study prepared by SEPC. 18 p.

24-Oct2007

47264970

Luc, L. (2001) Phyliq: Persistent Foaming After an Accelerated Storage 

Procedure at +54 Degrees Celcius for 14 days. Project Number 00/907005/038. 

Unpublished study prepared by SEPC. 18 p.

24-Oct2007

47264971 Luc, L. (2001) Phyliq: Free Acidity or Alkalinity. Project Number: 00/907005/027. 

Unpublished study prepared by SEPC. 18 p.

24-Oct2007

47264972

Luc, L. (2001) Free Acidity or Alkalinity After an Accelerated Storage Procedure at 

+ 54 C for 14 Days. Project Number: 00/907005/036. Unpublished study prepared 

by SEPC. 17 p.

24-Oct2007

47264973 Audeval-Gerard, C. (2000) Acute Oral Toxicity Study in the Rat. Project Number 

9912812, 990762T/Limvo/Phyliq. 27 p.

24-Oct2007

47264974 Audeval-Gerard, C. (2000) Acute Dermal Toxicity in the Rat. Project Number 

9912812, 990763T/LIMVD/PHYLIQ. 28 p.

24-Oct2007
Laminarin Page 26 

Biopesticide Registration Action Document

47264975

Smith, F. (2007) Toxicology Waiver Request - Acute Inhalation Toxicity: 

(Laminarin). Project Number: TOXLABS/1998/7020INH, 24634/61/5. Unpublished 

study prepared by SciReg, Inc. 81 p.

24-Oct2007

47264976

Audeval-Gerard, C. (2000) Acute Eye Irritation Study in the Rabbit. Project 

Number: 990760T/IPOCH/PHYLIQ, 9912812. Unpublished study prepared by 

Laboratories Goemar SA. 27 p.

24-Oct2007

47264977

Audeval-Gerard, C. (2000) Acute Skin Irritation Study in the Rabbit. Project 

Number: 9912812, 990759T/IPCCH/PHYLIQ. Unpublished study prepared by 

Laboratories GOEMAR SA. 27 p.

24-Oct2007

47264978

Audeval-Gerard, C. (2000) Skin Sensitisation Study in the Guinea Pig 

(Magnusson-Kligman Maximisation). Project Number: 990761/KINJCH/PHYLIQ, 

9912812. Unpublished study prepared by Laboratories GOEMAR SA. 37 p.

24-Oct2007

47264979

Tessier, C. (2001) The Effects of Phyliq (37 g/L Laminarin) on Aphidius 

rhopalosiphi (Hymenoptera, Braconidae) on Artificial Substrate in Laboratory: LR 

50 Estimation and Reproduction Assessment: Phyliq. Project Number: 

01APGOL25. Unpublished study prepared by Promo-Vert S.A. 18 p.

24-Oct2007

47264980

Tessier, C. (2001) The Effects of Phyliq (37g/L Laminarin) on Typhlodromus pyri 

(Acari, Phytoseiidae) on Artificial Substrate in Laboratory: LR 50 Estimation and 

Reproduction Assessment . Project Number: 01TYGOL24. Unpublished study 

prepared by Promo-Vert S.A. 22 p.

24-Oct2007

47283300

Laboratories Goemar SA (2007) Submission of Product Chemistry Data in 

Support of the Application for Registration of VacciPlant and the Petitions for 

Tolerance of Laminarin for Use on Food Crops. Transmittal of 2 Studies.

15-Nov2007

47283301

Trebert, R.; Cousin, C. (2002) Laminarin-Analytical Profile of One Batch 96S51. 

Project Number: BPL/200111/0388. Unpublished study prepared by Crepin 

Analyses & Controles. 54 p.

15-Nov2007

47283302

Comb, A. (2006) Iodus 40: Two Year Storage Stability. Project Number: 

GOM/005, GOM/005/063905. Unpublished study prepared by Huntingdon Life 

Sciences, Ltd. 32 p.

15-Nov2007

47391100

Laboratoires Goemar SA (2008) Submission of Product Chemistry and 

Toxicity Data in Support of the Application for Registration of VacciPlant 

and the Petition for Tolerance of Laminarin for Use on Food Crops.

02-Apr2008

47391101

Smith, F. (2008) Product Identity and Composition, Description of 

Beginning Materials and Description of Formulation Process: (VacciPlant). 

Unpublished study prepared by SciReg, Inc. 52 p.

02-Apr2008

47391102 Smith, F. (2008) Toxicology Waiver Request- Acute Inhalation Toxicity: 

(VacciPlant). Unpublished study prepared by SciReg, Inc. 65 p.

02-Apr2008

B. EPA Risk Assessment Memoranda
Laminarin Page 27 

Biopesticide Registration Action Document

Rexrode, M. Science Review in Support of New Product Registration Human Tolerance 

Application for VacciPlant, an End-use Product Containing the Active Ingredient Laminarin 

(3.5%) dated October 23, 2009.

Rexrode, M. Science Review in Support Support of a Tolerance Exemption Petition, Registration 

of an End-Use Product for VacciPlant that Contains Laminarin (3.5%) (3.5%) dated October 28, 

2008.

C. References

U.S. EPA. 1998. Guidance for Ecological Risk Assessment. Risk Assessment Forum. 

EPA/630/R-95/002F, April 1998.

U.S.EPA 2008. Terrestrial Residue Exposure Model (T-REX) Version 1.4.1. 

EFED/OPP/USEPA.

U.S.EPA 2004. Individual Effects Chance Model Version 1.1. EFED/OPP/USEPA.

U.S. EPA. 2004. Overview of the Ecological Risk Assessment Process in the Office of 

Pesticide Programs. Office of Prevention, Pesticides, and Toxic Substances. Office of Pesticide 

Programs. Washington, D.C. January 23, 2004.

APPENDIX A – BIOCHEMICAL PESTICIDE DATA REQUIREMENTS

TABLE 1. Physical/Chemical Properties for Laminarin

TABLE 1.0 Physical and Chemical Properties for pure TGAI Laminarina 

Guideline 

Reference 

No.

Property Description of Result Methods

830.6302 Color White MRID 47264908

830.6303 Physical State Powder MRID 47264908

830.6304 Odor Low odor MRID 47264908

830.6313 Stability Stable after 14 days at 54°C in the 

presence of aluminum acetate or 

aluminum

MRID 47264909

830.6314 Oxidation/Reduction: 

Chemical 

Incompatibility

No oxidizing properties MRID 47264911
Laminarin Page 28 

Biopesticide Registration Action Document

TABLE 1.0 Physical and Chemical Properties for pure TGAI Laminarina 

Guideline 

Reference 

No.

Property Description of Result Methods

830.6315 Flammability None flammable; neither development 

nor ignition of gas were observed after 

contact with water. An exothermic 

reaction was observed at 236°C±3°C 

(mean value). No self-ignition 

temperature was recorded up to 420°C.

MRID 47264912

MRID 47264913

MRID 47264914

830.6316 Explodability Not explosive MRID 47264915, 

checking heat, friction, 

and shock sensitivity 

830.6317 Storage Stability Not required for TGAI 

830.6319 Miscibility Not applicable, product is not an 

emulsifiable liquid and will not be 

diluted with petroleum solvents.

830.6320 Corrosion 

Characteristics

Not required for TGAI 

830.6321 Dielectric Breakdown 

Voltage

Not required for TGAI

830.7000 pH 6.25±0.02 at 23.2°C (1% w/v) MRID 47264920, by 

pH meter and a glass 

electrode

830.7100 Viscosity Not required for TGAI

830.7200 Melting Range No melting point could be determined. 

The test material became yellow at 204-

215C, then it turned brown at 216-

225.2C. At about 310.6-316.2C, the test 

material was completely retracted and 

blacked colored. The test material 

probably degraded during the test.

MRID 47264916, by 

using an 

Electrothermal 8103 

apparatus

830.7220 Boiling Range The test material is a powder.

830.7300 Relative Density D4

20 = 1.515±0.04 - 1.502±0.06 MRID 47264917 and 

47264918, by 

pycnometric method

830.7370 Dissociation Constant in 

Water

Can not be determined.

830.7550 Partition Coefficient Log P = -1.6 MRID 47264928, by 

shake flask method
Laminarin Page 29 

Biopesticide Registration Action Document

TABLE 1.0 Physical and Chemical Properties for pure TGAI Laminarina 

Guideline 

Reference 

No.

Property Description of Result Methods

830.7840 Water Solubility > 88.6 g/L at 20°C;

< 10 mg/L (n-heptane);

< 10 mg/L at 20°C (xylene, 1,2-

dichloroethane, and ethyl acetate);

60 mg/L (methanol);

21 mg/L at 20°C (acetone)

MRID 47264919

MRID 47264921

MRID 47264922

MRID 47264923

MRID 47264924

MRID 47264925

MRID 47264926

by flask method

830.7950 Vapor Pressure < 2.6 x 10-5Pa at 25°C MRID 47264927, using 

a vapor pressure balance 

system

TABLE 2. Toxicity Data Requirements Summary 

Table 2. 0 Toxicological Results/ Category

Guideline #

Test

Results/Toxicology 

Category

MRID Study Conclusion

870.1100

Acute Oral

LD50>2,000 mg/kg

III

47264930

47264943

Acceptable

870.1200

Acute Dermal

LD50>5,000 mg/kg

IV

47264931

47264974

Acceptable

870.1300

Acute Inhalation

> 1.02 mg/L

III

47264932 Acceptable

870.2400

Primary Eye Irritation

Non irritating

IV

47264933

47264976

Acceptable

870.2500

Primary Dermal 

Irritation-Rabbits

Non- irritating

IV

47264934 Acceptable

870.2600

Dermal Sensitization

Not a sensitizer

IV

47264935

47264978

Acceptable 

Acute Subcutaneous LD50>1,000 mg/kg 47264936 Acceptable

870.3050

28 day Oral ToxicityRat

NOEL=1,000 mg/kg/day 47264937 Acceptable

870.3100

90 day Oral ToxicityRat

NOEL=1,000 mg/kg/day 47264938 Acceptable

870.3150

Subchronic Oral 

Toxicity (gavage) - Dog

NOEL=1,000 mg/kg/day 47264939 Acceptable

870.3700a

Prenatal Developmental 

Toxicity Study - Rat

Maternal NOEL > 1,000 

mg/kg/day

Developmental NOEL > 

1,000 mg/kg/day

47264940 Acceptable 
Laminarin Page 30 

Biopesticide Registration Action Document

Table 2. 0 Toxicological Results/ Category

Guideline #

Test

Results/Toxicology 

Category

MRID Study Conclusion

870.3700b

Prenatal Developmental 

Toxicity Study - Rabbit

Maternal LOAEL = 1,000 

mg/kg/day

Developmental LOAEL = 

1,000 mg/kg/day

47264941 Acceptable 

870.5100

Bacterial Reverse 

Mutation Test

There was no evidence of 

induced mutant colonies 

over background

47264942 Acceptable

870.5300

In Vitro Mammalian 

Cells in Culture Gene 

Mutation Assay

There was no evidence of 

induced mutant colonies 

over background.

47264943 Acceptable

870.5395

Bone Marrow

Micronucleus assay in 

mouse

No toxicity was noted in 

either sex at any dose up 

to the limit dose of 2000 

mg/kg bw

47264944 Acceptable

870.7800

Immunotoxicity 

Waiver Request 47264945 Acceptable 

TABLE 3. EcoToxicity Data Requirements Summary

Table 3.0 Ecotoxicity Data

Guideline #

Test

Results/Toxicology 

Category

MRID Study 

Conclusion

850.1010

Acute Toxicity Test, Daphnids 

EC50 >100 mg/L. 47264947 Acceptable

850.1075 

Acute Toxicity Freshwater Fish

Danio rerio

96 hr LC50 >100 mg/L. 47264948 Acceptable

850.1075

Fish Acute Freshwater 

Rainbow Trout

Oncorhynchus mykiss

96-hr LC50 >100 mg/L. 47264949 Acceptable

850.2100

Avian Acute Oral Toxicity 

Bobwhite (Colinus virginianus) 

LD50 >2000 mg/kg 47264950 Acceptable

850.2200

Avian Dietary Toxicity 

Bobwhite (Colinus virginianus)

LC50 >5000 ppm 47264951 Acceptable

850.3020

Acute Contact Toxicity 

Honey bee (Apis mellifera)

LD50 >118.64 μg/bee

48-hr contact LD50 >100.00 

μg/bee.

47264952 Acceptable

850.5400

Algal Toxicity, Tiers I and II

Green alga Selenastrum capricornutum.

EbC50, ErC50, NOECb, and 

NOECr for the test material at 

24, 48, and 72 hours were 

each >100 mg/L

47264953 Acceptable
Laminarin Page 31 

Biopesticide Registration Action Document

Table 3.0 Ecotoxicity Data

Guideline #

Test

Results/Toxicology 

Category

MRID Study 

Conclusion

835.3110

Biodegradability

Biodegradation in the 

reference material and toxicity 

controls was 71% and 65%, 

respectively, after 14 days. 

Laminarin was concluded to 

be readily biodegradable 

under the test conditions.

47264954 Acceptable

880.4350

Nontarget Insect Testing 

Exposure to 10.0 L/ha of the 

test material did significantly 

lower the fecundity of A. 

rhopalosiphi females 

compared to the untreated 

control. However, the product 

label for Vacciplant 

recommends an application 

rate of 9.7 to 14.4 oz/A, which 

the reviewer calculates to be 

equivalent to 0.7 to 1.05 L/ha, 

well below the 10.0 L/ha rate 

at which fecundity was 

affected.

47264979 Acceptable