Proposed Registration Decision for the New Active 

Ingredient Male Sea Lamprey Mating Pheromone 

. Housenger, Director 

Office of Pesticide Programs 

Date: 9 ~ o v ~ M ~ CZ...l'°L 2 o '-5 
Summary 

This document announces that the Environmental Protection Agency (EPA) has completed its 

initial evaluation of the proposed new biochemical pheromone Male Sea Lamprey Mating 

Pheromone and has concluded that it meets the regulatory and safety standards under the Federal 

Insecticide, Fungicide and Rodenticide Act (FIFRA). 

Two products arc proposed to be registered under Section 3(c)(5) of FIFRA: a Manufacturinguse Product (MP), Male Sea Lamprey Mating Pheromone Technical; and an End-use Product 

(EP). Male Sea Lamprey Mating Pheromone. The registrant for these products is the United 

States f-ish and Wildlife Service (USFWS). the agency charged with controlling the spread of the 

pest. Sea Lamprey. The new active ingredi ent will be used as an attractant to trap Sea Lampreys 

(Petromyzon marinm) during their spawning season. The EP is only intended for use on the 

upstream po11ions of the tributaries of the Great Lakes, Lake Champlain, and the Finger Lakes 

areas (i.e. the Great Lakes Basin), where Sea Lamprey are an invasive species. wreaking havoc 

on the nati ve fisheries. Due to the international nature of the Sea Lamprey incursion, the two 

Male Sea Lamprey Mating Pheromone products are being jointly registered with Canada; and the 

EP will be applied in a coordinated effort by the two governmental agencies charged with 

controlling this pest - USfWS and Fisheries and Oceans Canada. The registration of this active 

ingredient is considered by USFWS to be in the public interest, and is expected to be an 

important tool in protecting our Great Lakes ecosystem and fisheries. 

The chemical nomenclature for Male Sea Lamprey Mating Pheromone is 3-ketopetromyzonol 

sulfate, ammonium salt (3kPMZS). The compound occurs naturally as a pheromone excreted by 

Sea Lamprey; however, the scale of commercial pesticidal application necessitates synthetic 

production. In its concentrated form, the compound is a crystalline solid, and is stable in longterm storage. but dissociates readily in solvents. allowing for effective dispersal in aquatic 

environments. 

As a biopesticicle, Male Sea Lamprey Mating Pheromone is classified as a pheromone and serves 

primarily as an attractant for breeding female Sea Lamprey during spawning season. The EP is 

time-released out of traps in tributaries where Sea Lampreys spawn. Like other federally 

registered pheromones, Male Sea Lamprey Mating Pheromone is efficacious in trace amounts. 

The EP contains 1.06% w/w 3-ketopetromyzonol sulfate, ammonium salt as its active ingredient, 

and has an applied concentration between 4.72 to 0.0472 parts per trillion (ppt). Pesticidal 

applications notwithstanding, the total concentration of 3kPMZS is not anticipated to exceed 

background levels in places where Sea Lamprey are naturally found (concentrations of natural 

3kPMZS during the middle of spawning season range from 33.4 ppt to 120.9 ppt). The EP is to 

be applied only during spawning season. which occurs from April through June. The pheromone 

has a half-life of 26 hours, and is not detectable within a month of the end of spawning season. 

No adverse effects from 3kMPZS have ever been observed or reported in any aquatic 

environments (to either humans or nontarget organisms) where Sea Lamprey are native; and 

USFWS has not observed toxic effects from exposure to these compounds in the Great Lakes 

area since they first began monitoring the compound there in 2004. 

The control or Sea Lamprey is of critical importance to USFWS and Fisheries and Oceans 

Canada. the t\\O go,·crnmental agencies responsible for protecting the aquatic environment in the 

Great Lakes region. The Sea Lamprey is a predatory fish that attaches to host fish and feeds on 

Page 2 of 9 
the blood and body fluids. A single Sea Lamprey kills 40 or more pounds of fish in its life as a 

parasite. Sea Lamprey invaded the Great Lakes region in earnest in the late 19111 century when a 

canal wen t around Niagara Falls and connec ted Sea Lamprey habitat in the lower Niagara to the 

Sea Lamprey-free waters of the Great Lakes. By the 1950s. ca Lamprey predation in the Great 

Lakes region had caused population crashes of the folio' ing native fish: Lake Trout. Salmon. 

Steel head. Whitefish. Chubs. Burbot and Walleye. A coordinated program of mechanical 

trapping and lampricide use. begun in the 1950s, has restored those fisheries to health. and has 

reduced Sea Lamprey populations by mo re than 90%. USFWS is anticipating signilieant gains in 

trapping (20%) with the broader use of the new acti ve ingredient Male Sea Lamprey Mating 

Pheromone. 

While Male Sea Lamprey Mating Pheromone is considered a new active ingredient under 

Section 3 o f FIFRA, it had been previously approved in several Experimental Use Permits 

(75437-EUP-1 through -4), the first pennit being issued on February 5, 2004. The Agency has 

more than a decade-long history with the active ingredient and is in receipt of a substantial 

database. which supports both the human health risk assessment and the ecological risk 

assessment. The risk assessment c learly demonstrates that exposure to this pheromone will be de 

minimus. and that, exposure notwithstanding, the pheromone is nontoxic to humans and 

nontarget organisms thrnugh any route of exposure. 

Background 

Male Sea Lamprey Mating Pheromone was classified as a biochemical pesticide by the 

Biochemical Classification Committee o n March 22, 2000, due to its natural occurrence, history 

of exposure to humans and the environment without toxicity and its nontoxic mode of action as a 

pheromone. With regard to toxicological history, there have been no observed adverse effects 

from Male Sea Lamprey Mating Pheromone in any aquatic environment where Sea Lamprey are 

indigenous. 

On January 29, 2003, the U .. Environmental Protection Agency (""EPA'.) received an 

application from Great Lakes Fishery Commission for an Ex perimental Use Permit (EUP) 

containing the new active ingredient Male Sea Lamprey Mating Pheromone. On April 9. 2003. 

EPA announced receipt of an application for an EUP containing that new acti ve ingredient 

(Volume 68. Number 68. FR page numbers 17374 - 17375). Six supporting documents. 

including a human health risk assessment, an ecological risk assessment and a product chemistry 

assessment were posted in Docket OPP-2003-0080. No comments were received relative to the 

application or those assessments. The EUP using this acti ve ingredient was issued on February 9. 

2004. 

On October 30. 20 13. EPA announced receipt of a Section 3 application to register two new 

products conta ining the new active ingredient - Male Sea Lamprey Mating Pheromone Technical 

and Male Sea Lamprey Mating Pheromone (Volume 78, Number 2 10, FR page numbers 64937 -

64938). The applicant was USFWS. A copy of that notice is available in Docket ro Number 

EPA-HQ-OPP-2013-0538 via htto:llw1nr.reg11/utions.gor. No comments were submitted in 

response to the announcement. 

Page 3 of 9 
Evaluation 

In c,·aluating a pesticide registration application. the EPA assesses a "viclc variety of pesticiclespeci !ic information inc luding where and how the pesticide is used. environmental la te (i.e .. 

\\hat happens to the pcsti ciue o nce it's applied), and toxicity studi es (i.e .. e ffec ts on humans and 

other nontarget organisms) to determine the likelihood of adverse effects (i.e .. risk) from 

exposures assoc iated " ·ith the proposed use of the product. Risk assessments are developed to 

e\ aluate the em·ironmcntal fate or the compound as well as how it might affect a wide range of 

nontargct organisms including humans and terrestrial and aquatic wildlife (plants and animals). 

On the basis or these assessments. EP J\ evaluates and approves language for each pesticide label 

to ensure the directions for use and safety measures are appropriate to mitigate potential risk. In 

this \\'ay. the pesticide's labd he lps to communicate essential limitations and mitigations that arc 

necessary for public safety. It is a FIFRA violatio n to use a pesticide in a way that is inconsistent 

with the label. 

The human health and environmental risk assessments (including an endangered species 

assessment) supporting this decision as well as the draft labeling can be found in the regulatory 

docket (Document ID: EPA-HQ-OPP-2013- 0538). 

The application for registration of Male Sea Lamprey Mating Pheromone was reviewed jointly 

with Canada"s pesticidal regulatory agency, PMRA. All data requirements for each agency were 

respectively addressed; and the agencies were able to share reviews with each other, resulting in 

a more robust risk assessment. The joint review and proposed registration is particularly notable 

as the registration o f Ma le Sea Lamprey Mating Pheromone is being sponsored by governmental 

agencies in each country; and the EP is being unique ly employed as a tool of environmental 

protection intended to redress the environmental damage of a particularly harmful invasive 

species. which is plaguing both countries. 

Assessment of Risk to Human Health 

EPA requires a wide range of studies in order to assess a pesticide. For Male Sea Lamprey 

Mating Pheromone, the database of studies and information supporting the assessment of risk to 

human health is sufficient to support registration of this non-food use pheromone. There is ample 

information indicating that the use of Male Sea Lamprey Mating Pheromone will not result in 

any meaningful new exposure, and that, exposure notwithstanding, the compound is nontoxic 

and does not pose a risk through any other route of exposure. 

Due to the extremel y high cost of manufacturing the test substance as well as the large quantities 

of test substance required for limit dose testing for Tier I human health data requirements, 

USFWS proposed submitting alternative in vitro testing studies to EPA (and PMRA) in 

fulfillment of many of the human health testing data requirements for both agencies as part of the 

joint review process. After a review of the protocols and the studies. EPA and PMRA, have 

detennined that all the human health data requirements for a biochemical have been satisfied and 

that the human health risk assessment is sufficient to support registration. All the information 

submitted demonstrate that Male Sea Lamprey Mating Pheromone is nontoxic to humans. 

Page 4 of 9 
With regard to acute toxicity data requirements, nonguideline in vitro testing studies were 

submitted in support of those data requirements. In the acute oral toxicity study. the acute oral 

LDso value was determined to be >2000 mg/kg bw (Toxicity Category III); and intracellular ATP 

concentration were >3000 μM , indicating very low cytotoxicity for Male Sea Lamprey Mating 

Pheromone Technical. An in vitro study for acute dermal toxicity established an LDso >2000 

mg/kg bw (Toxicity Category 111); and there was no observed cytotoxicity. A nonguideline in 

vitro testing study in support of the acute inhalation toxicity data requirement was deemed 

supplemental ; and a determination was made that because of the lack of inhalation exposure. 

further information in support of the requirement was not necessary. The active ingredi ent is not 

a volatile substance and it is applied in an aqueous environment; as such, no inhalation exposure 

is expected. A nonguideline in vitro study submitted in support of the primary eye irTitation data 

requirement indicated that the active ingredient is a mild ocular irritant; accordingly, it was 

classified as Toxicity Category Ill. The nonguideline in vitro testing study was submitted in 

support of the primary dermal irritation requirement; and the compound was classified as 

Toxicity Category JV. The nonguideline in vitro study submitted to fulfill the dermal 

sensitization data requirement concluded that the active ingredient is a weak sensitizer. 

The in formation submitted in support of the appli cation for the acti ve ingredient Male Sea 

Lamprey Mating Pheromone indicate that it is not subchronically toxic. Repeated exposure to 

Male Sea Lamprey Mating Pheromone via oral, dermal, and inhalation pathways is highly 

unlikely. The MP is manufactured in small batches ranging from 10 to 100 g, no more than once 

or twice per year with maximum annual production not exceeding I kg. The MP is manufactured 

in an enclosed environment using prescribed personal protective equipment, and is packaged in 

hermetically sealed vials. The EP is then formulated, using 0.1 0 g of the MP in IO mL 50% 

sol vent-based mixture. The EP is then placed in traps, which are placed in the waters of the 

affected tributaries, where the active compound is slowly time released. No significant exposure 

to the MP or EP is anticipated. Subchronic oral toxicity data requirements were satisfied tlu·ough 

rationales and supported by the in vitro studies and by information from the open scientific 

literature. With specific regard to the 90-day oral toxicity requirement. the human health 

assessment further notes: ( I) repeated exposure via drinking water is highly unlikely due to a 

lack of curTent use of the target streams as sources of municipal drinking water; and if this use 

did occur, it would not be different than using water from Sea Lamprey infested streams during 

spawning: and (2), the estimated acute systemic LDso was >2000 mg/kg bw, which is far greater 

than the effective applied rate of- I0"12M. With regard to the 90-day dem1al toxicity data 

requirement, the human health assessment notes: (1) the MP and EP are not intended for direct 

application to human skin and are not manufactured in a manner that would result in prolonged 

or repeated dermal contact; (2) the estimated acute systemic LDso was >2000 mg/kg bw in in 

vitro testing for acute systemic toxicity. which is far greater than the effective applied rate of 

- 1 o- 12M; and (3) The TGAI was estimated to be non-irritating. With regard to the 90-day 

inhalation toxicity data requirement, the assessment reiterates that no inhalation exposure is 

anticipated for either the MP or the EP. The MP is a non-volatile solid that is manufactured in a 

manner that would not result in repeated inhalation exposure; and the EP is an aqueous solution 

that is time-released into streams, whose resulting concentrations fall within background levels. 

In short, no subchronic exposures are expected; and any exposure would be within natural 

background levels. 

Mutagcnicity data requirements were satisfied similarly by a rationale supported by infom1ation 

from the scientific literature. Male Sea Lamprey Mating Pheromone is a non-food use 

Page 5 of 9 
pheromone that will be applied temporall y, and whose use will result in concentrations that fall 

within background levels. Accordingly, the use of the active ingredient will not result in repeated 

exposure to humans via oral, dermal, or inhalation routes of exposure. 

The developmenta l toxic ity data requirement for Male Sea Lamprey Mating Pheromone was also 

satisfied by a rationale, and was supported by information from the scientific literature. The basis 

of the rationale is that the active ingredient is not intended for food use, and the use of products 

containing the compound will not result in any significant exposures to humans above 

background levels. 

Lastly, EPA has not found Male Sea Lamprey Mating Pheromone to share a common 

mechanism of toxicity with any other substances. In addition, Male Sea Lamprey Mating 

Pheromone does not appear to produce a toxic metabolite produced by other substances. 

Given the demonstrated lack of adverse effects on humans, a qualitative assessment of Male Sea 

Lamprey Mating Pheromone is considered suf1icient. Humans are rare ly exposed to this nontoxic 

pheromone and there have been no observed or reported adverse effects on humans who are 

regularly present in and around Sea Lamprey habitat. The active ingredient will be used at low 

rates in water, and its use will result in concentrations withi n natural background levels. Also, the 

EP will only be used during spawning season, April - June. Furthermore, Male Sea Lamprey 

Mating Pheromone is expected to biodegrade rapidly. Information submitted by USFWS shows 

that the active compound has a half-life of26 hours, and that traces of the compound are not 

found in the water within a month of the end of spawning season. Due to the infrequent 

applications. low application rate, high biodegradability, the pesticidal use of Male Sea Lamprey 

Mating Pheromone is not anticipated to contribute signifi cantl y to human exposure beyond 

existing (but temporal) background levels. 

Assessment of Ecological Risk 

Environmental Fate 

Environmenta l fate and groundwater data are not required at this time because the results of the 

nontarget organism toxicity assessment (Tier I data requirements) did not trigger these Tier II 

data requirements. However, as referred to above, Male Sea Lamprey Mating Pheromone is not 

expected to persist in the environment. Male Sea Lamprey Mating Pheromone has a half-life of 

26 hours; and USFWS monitoring, done in conjunction with their Male Sea Lamprey Mating 

Pheromone EU Ps, indicate that no traces of the pheromone are detected within a month of the 

end of spawning season. 

Environmental Effects 

The nontarget organism data requirements for Male Sea Lamprey Mating Pheromone were 

satisfied through rationales, which are supported by nonguideline studies and information from 

the open scientific literature. Both EPA and PMRA have concurred on an ecological risk 

assessment: and both agencies find that there are no concerns for nontarget aquatic or terrestrial 

organisms resulting from the use of Male Sea Lamprey Mating Pheromone. 

Page 6 of9 
The rationales for all the nontarget organism data requirements demonstrate that nontarget 

organisms will only be negligibly exposed to the active ingredient and that those miniscule 

exposures are not toxic to nontarget organisms. With regard to aquatic nontarget organisms, data 

indicate that the use of the acti ve ingredient will result in concentrations of the compound that 

are within background levels where male Sea Lamprey are naturally present during spawning 

periods. (USFWS monitoring has demonstrated that there is no additional efficacy re lative to any 

concentrations above natural background levels.) Appli cation of the Male Sea Lamprey Mating 

Pheromone is expected to result in treated water with concentrations of 4. 72 to 0.04 72 ppt. well 

within the range of concentration of the pheromone in native Sea Lamprey habitat during 

spawning season, which can reach concentrations of 120.9 ppt. Applications of the active 

ingredient are also both targeted and temporal. Mal e Sea Lamprey Mating Pheromone is only to 

be used in the upstream portions of affected tributaries. and it is only applied during spawning 

season (April through June). Moreover, the active compound does not persist in the environment. 

It has a half-life of 26 hours and is not found in Sea Lamprey inhabited waters within a month 

after application. With regard to toxic effects on aquatic nontarget organisms, there have been no 

observed adverse effects from the use of the compound in waters where Sea Lamprey are 

indigenous, and there have been no observed adverse effects by USFWS staff, who have 

monitored such effects since they began experimenting with the pheromone in 2004. With 

regard to te rrestrial nontarget organisms. no exposure is anticipated. Applications of Male Sea 

Lamprey Mating Pheromone are specifically targeted to aquatic environme nts; it is to be applied 

in traps in streams in miniscule amounts. In short, there are no plausible exposures for terrestrial 

organisms. Based on de minim us exposures, and lack of observed toxicity for this naturally 

occurring compound. the ecological risk assessment concludes that there are no risks to either 

aquatic or terrestrial nontarget organisms. 

Endangered Species Assessment 

An endangered species assessment on Male Sea Lamprey Mating Pheromone fu11her quantifies 

and elucidates Male Sea Lamprey Mating Pheromone's nontoxicity to nontarget organisms and 

indicates that significant exposure to nontarget organisms is not anticipated. The active 

ingredient, 3-ketopetromyzonol sulfate (3-kPMZS), is not toxic to the target pest. It is a 

pheromone used to attract Sea Lamprey into traps. When applied as a pesticide in traps it results 

in concentrations of 4.72 to 0.0472 ppt in the treated waters. Exposure of nontarget organisms to 

the active ingredient is anticipated to fall well within natural background levels emitted by ca 

Lamprey during spawning season, which can range as high as 120. 9 ppl. The compound does 

not persist in the environment and has an average half-life of 26. 1 hours ± 1.8. Naturally 

occurring Sea Lamprey pheromones have been observed in Great Lakes tributaries for over 60 

years and no toxic effects from exposure to these compounds has ever been observed or reported. 

The Agency a lso conducted a search (10/ 14/20 15) of the Ecological Incident Information System 

version 2.1. I (EIIS) and did not find any reports of detrimental exposure of 3-KPMZS or the 

inert, methyl alcohol, to aquatic or terrestrial species. In addition, efficacy studies demonstrated 

that nontarget species were not more likely to be captured in Male Sea Lamprey Mating 

Pheromone-baited traps when compared to unbaited traps. Due to its nontoxic mode of action (as 

a pheromone/attractant/confusion agent) and its low exposure to nontarget species (natural 

background levels not exceeded) a Risk Quotient (RQ) is not typically calculated since the point 

estimates of e ither toxicity and/or exposure will usually be at or near zero: and none was needed 

here. The endangered species assessment concludes that Male Sea Lamprey Mating Pheromone 

has no known direct or indirect toxic effects to nontarget organisms: and EPA has determined 

Page 7 of 9 
that the use of the active ingredient Male Sea Lamprey Mating Pheromone will result in .. No 

Effect" to any currently listed threatened or endangered species or any designated critical habitat. 

Alternatives 

There are two conventional lampricide acti ve ingredients - TFM (3-trifluoromethyl-4-

nitrophenol) and Niclosamide (2',5-dichloro-4'-nitrosalicylanilide) - that are currentl y used in 

seven registered products for the purpose of Sea Lamprey control. Both TFM and Niclosamide 

products are used at higher rates and each has a higher toxicological risk profile than Male Sea 

Lamprey Mating Pheromone. Use data indicate an average of approximately 80.000 pounds of 

TFM active ingredient and approximately 300 pounds of Niclosamide active ingredient are 

appl ice! annually. Water concentrations of TFM are typically 12 ppm throughout treated areas: 

and liclosamicle concentrations range from 25 to 35 ppb in treated areas. There are no natural 

background levels for either conventional active ingredient. With regard to toxicity, TFM has an 

acute oral LD5o values of 141 and 160 mg/kg for males and females, respectively. It is also 

considered to be toxic to both lish and nontarget plants. iclosamide is highly toxic to both fish 

and nontarget aquatic im·ertebratcs. 

Benefits 

Sea Lamprey in the Great Lakes region are currently controll ed by blocking their access to 

spawning habitat through physical barriers and by deploying chemical pesticides (lampricides) 

where they successfully reproduce. In speci fie streams, the number of young produced by adult 

Sea Lamprey can be reduced if most of the adults are trapped and removed before spawning. 

And even if that stream must be treated with a lampricide subsequentl y, a smaller initial 

population will leave fewer surviving Sea Lamprey. Therefore, improvements in trapping 

technology can advance Sea Lamprey controls exponentially. 

The addition of Male Sea Lamprey Mating Pheromone to the trapping arsenal has recently been 

shown to increase Sea Lamprey trap catch. In large streams, especially those with few adult Sea 

Lamprey, application of Male Sea Lamprey Mating Pheromone increased the removal rate by 

20-40%. Because the pheromone is a natural compound released by Sea Lamprey and very little 

is needed to induce a behavioral response, its application is viewed as a much more 

environmentally benign means of chemically controlling Sea Lamprey populations than through 

the mere use of conventional lampricides. It is further expected that the improved removal rate. 

created through the use of Male Sea Lamprey Mating Pheromone, will result in a diminished and 

more targeted use of the more toxic conventional lampricides; and it will have the further effect 

of restoring the native ecosystem and fishery by significantly reducing the numbers of this 

predatory invasive species. 

Notably. Male Sea Lamprey Mating Pheromone will be the first vertebrate pheromone ever 

registered as a biopesticide. Presently, over 40 registered pheromone active ingredients are safely 

used to control hundreds of pest insects. That targeted use of these pheromone products on 

insects has been an important tool in agricultural pest control over the last two decades, 

successfully reducing the use of more toxic conventional insecticides. It is expected that the 

addition of this new active ingredient will help set the stage for the development of other 

vertebrate pheromones. 

Page 8 of 9 
Public Comments 

On Apri l 9. 2003, EPA announced receipt of an application for an EUP (sec 5) containing a new 

active ingredient Male Sea Lamprey Mating Pheromone (Volume 68, Number 68. FR page 

numbers 17374 - 17375). Six supporting documents. including a human health risk assessment, 

an ecological risk assessment and a product chemistry assessment were posted in Docket OPP2003-0080. No comments were received in conjunction with that application or those 

assessments. 

On October 30. 20 13. EPA announced receipt of an application to register products (sec 3) 

containing a new active ingredient - Male Sea Lamprey Mating Pheromone Technical and Male 

Sea Lamprey Mating Pheromone (Volume 78, Number 2 10, FR page numbers 64937 - 64938). 

The appli cant was a federal partner, USFWS. A copy of that notice is avai lable in Docket ID 

Number EPA-HQ-OPP-2013- 0538 via hllu: 1nrn'. r er,,:u/01ions.g<ff. No comments were 

submined in response to the announcement. 

Proposed Regulatory Decision 

The Male Sea Lamprey Mating Pheromone database - which includes a battery ornonguideline 

in vitro studies, open scientific literature and data from USFWS's monitoring or EUPs 

containing Male Sea Lamprey Mating Pheromone - is adequate and supports the pesticidal nonfood use of Male Sea Lamprey Mating Pheromone. In considering the assessed risk to human 

health and the environment. the Agency concludes that Male Sea Lamprey Mating Pheromone 

meets the regulatory standard under the Federal Insecticide. Fungicide and Rodenticide Act 

(FIFRA). There are no outstanding data requirements for this biochemical. Therefore. the EPA is 

proposing to grant the unconditional registration of the Male Sea Lamprey Mating Pheromone as 

a new active ingredient (non-food use) under Section 3(c)(5) of FffRA. 

Two products are proposed to be registered: Male Sea Lamprey Mating Pheromone Technical is 

a Manufacturing-use Product (MP) and Male Sea Lamprey Mating Pheromone is an End-use 

Product (EP). Applications of the EP are made in the tributaries of the Great Lake Region during 

Sea Lamprey spawning season from April through June. Applications are made in traps through 

a regularized drip, resulting in an applied concentration between 4.72 to 0.0472 ppt during that 

time period. Resulting concentrations in those tributaries are expected to be within background 

levels in places where Sea Lamprey are naturall y found. 

The human health and ecological risk assessments supporting this decision as well as the draft 

labeling can be found in the regulatory docket (Docket ID EPA-HQ-OPP-2013- 0538). 

Page 9 of 9