UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

DECISION MEMORANDUM 

O FFICE O F CIID IIC \1. SAFE f\ 

ANI> I'OL LIIT IO:'I' l'l{f.\'ENT IO 

SUBJECT: Registration of the New Active Ingredient Oxathiapiprolin 

TO: 

FROM: 

Jack Housenger, Director 

Office of Pesticide Programs 

Susan Lewis 

Director, Registration Division 

Office of Pesticide Programs 

This memorandum recommends that you concur on the registration of the new active 

ingredient oxathi apiprolin, a broad-spectrum fungicide for foliar or soil use on brassica, head and 

stem. crop subgroup SA; bulb onion crop subgroup 3-07 A; cucurbit vegetables, crop group 9; 

fruiting vegetables, crop group 8-10: grapes (import only): green onion, crop subgroup 3-078 ; 

leafy greens, crop subgroup 4A: peas, edible-podded; peas, succulent. shelled; ginseng root; 

tuberous and conn vegetables, subgroup I C; Tobacco; and golf course turf. It is also for use on 

ornamental plants grown in greenhouses, shade houses. lath houses. hoop houses, nurseries, and 

commercial landscapes. A summary of the human health and environmenta l fate and effects risk 

assessments and the final regulatory decision are in the attached Final Decision Document. The 

Science Divisions have reviewed all available data and the Registration Division has concluded 

that the criteria for registration under FlFRA section 3(c)(5) have been met. 

RECOMMENDATIONS: 

I recommend for the registration of oxathia its metabolites and 

degradates under FIFRA section 3(c)(5). 

onconcurr _______________________________ ___ 

Jack Housenger. Director Oftice of Pesticide Programs 

Attachment: Final Decision Document 
Registration Decision for the New Active Ingredient 

Oxathiapiprolin 

ckj:. ousenger, Director 

Office of Pesticide Programs 

Date: "B'[J.-1 i i{ -----+--+,--------------
SUMMARY 

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

evaluation of the data/information submitted to support the new fungicide oxathiapiprolin. The 

Agency has determined that it meets the regulatory and safety standards under the Federal 

Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic 

Act (FFDCA). The dataset for this application is complete. 

Oxathiapiprolin is a fungicide for control of downy mildew (caused by Pythium spp) and late 

blight (caused by Phytophthora spp.) diseases on food, ornamental crops and golf course turf. 

Five products are being unconditionall y registered under Section 3(c)(5) of FIFRA - a technical 

and two end-use products by E. I. de Pont de Nemours & Company (DuPont): "DuPont Zorvec 

Technical," "DuPont Zorvec Enicade Fungicide," and "DuPont Zorvec Epicaltrin Fungicide". 

Syngenta Crop Protection has two end-use products being registered: "Oxathiapiprolin FHG 

OD" and "Oxathiapiprolin FHG SC." 

DuPont applied for the following food crops: Brassica, Head and Stem, Crop Subgroup SA; Bulb 

Onion Crop Subgroup 3-07 A; Cucurbit Vegetables, Crop Group 9; Fruiting Vegetables, Crop 

Group 8-1 0; Grapes (import only); Green Onion, Crop Subgroup 3-07B; Leafy Greens, Crop 

Subgroup 4A; Dried Fruiting Vegetables; Peas, edible-podded; Peas, succulent, shelled; Ginseng 

Root; Tuberous and Corm Vegetables, Subgroup 1C and non-food use for Tobacco. The 

approved labeling contains maximum application rates of oxathiapiprolin on crops ranging 

between 0.1245 lb. a.i./ A/year for most foliar applications and 0.5006 lb. a.i./ A/year for soil 

applications with 2 to 5 retreatments (12 drench treatments for ornamental use) at a range of 

minimum intervals between 3 to 14 days. The pre-harvest interval ranges from 0 to 14 days. 

Syngenta applied for the following non-food uses: ornamental plants grown in greenhouses, 

shade houses, lath houses, hoop houses, nurseries, commercial landscapes and golf course turf. 

For DuPont and Syngenta, the approved oxathiapiprolin label directions allow this pesticide to be 

applied to either plant foliage or to the soil but not both. Product application methods are by 

ground and air sprays, aerial, chemigation, soil drench/spray, drip irrigation, and hand sprayer 

(greenhouse use only). 

The approved end-use product label directions are for use by professional applicators (not 

intended for homeowner application). Oxathiapiprolin is approved for use on brassica, head and 

stem, crop subgroup SA; bulb onion crop subgroup 3-07 A; cucurbit vegetables, crop Group 9; 

fruiting vegetables, crop group 8- 1 0; grapes (import only); green onion, crop subgroup 3-07B; 

leafy greens, crop subgroup 4A; peas, edible-podded; peas, succulent, shelled; ginseng root; 

tuberous and conn vegetables, subgroup 1 C; Tobacco; and turf. In additional, oxathiapiprolin is 

approved for uses in greenhouses on ornamental plants, tomatoes, cucumbers, summer squash, 

bell peppers, and non-bell peppers. All other food uses on the labels will have a restriction 

statement against applications in a greenhouse because they were not requested and thus not 

assessed. 

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EPA determined that oxathiapiprolin met the criteria for reduced risk status for all food and nonfood uses. The toxicology database is considered complete. For human health, EPA conducted a 

qualitative risk assessment, in which toxicological endpoints and points of departure (POD) were 

not evident for oxathiapiprolin. Currently, there are no maximum residue levels (MRLs) 

established in other countries for oxathiapiprolin. Numerical tolerances were not needed but 

established only to support future international harmonization purposes. Therefore, when MRLs 

are established by other regulatory agencies, it is expected that those MRLs will be harmonized 

with the U.S. tolerance. 

Oxathiapiprolin is a broad-spectrum fungicide with preventative, residual, systemic, eradicative, 

and antisporulant properties for foliar and soil-borne fungal diseases. It provides a different mode 

of action than other fungicides and thus could minimize disease resistance. As approved, it is 

applied in a scheduled protective program and used in an application rotation program with 

products with a different mode of action. 

BACKGROUND 

EPA received DuPont's three product applications on 12/3/2013 and received Syngenta's two 

product applications on 113/2014. DuPont's applications were also submitted for simultaneous 

review to the Pest Management Regulatory Agency (PMRA) of Canada. Syngenta's non-food 

ornamental plant applications were only submitted to EPA because registration for these uses is 

not being requested for use in Canada. 

EPA and PMRA conducted a global joint review of oxathiapiprolin food uses with participation 

from Australia, Mexico and Japan. Regulatory observers from South Korea, China, and the 

Philippines also participated. Each country conducted primary or secondary review for the 411 

studies submitted. Human health and ecological risk assessments were developed by EPA and 

PMRA individually. 

DuPont petitioned EPA under the FFDCA to establish tolerances for the food crops listed above. 

At this time, there are no established maximum residue limits (MRLs) for oxathiapiprolin by 

Codex or PMRA. 

EVALUATION OF RISK TO HUMAN HEALTH AND THE 

ENVIRONMENT 

In evaluating a pesticide registration application, the EPA assesses a wide variety of pesticide 

specific information including where and how the pesticide is used, environmental fate (i.e., 

what happens to the pesticide once it's applied), and toxicity studies (i.e. , hazards) to determine 

the likelihood of adverse effects (i. e., risk) from exposures associated with the proposed use of 

the product. The environmental fate properties of the pesticide are characterized by EPA. Also, 

risk assessments are developed to evaluate the compound as to how it might affect a wide range 

of non-target organisms including humans and terrestrial and aquatic wildlife (plants and 

animals). On the basis of these assessments, EPA evaluates and develops language for each 

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pesticide label to ensure the directions for use and safety measures are appropriate to mitigate 

any risks of concern. In this way, the pesticide label communicates to the user the essential 

limitations and mitigation measures to ensure no unreasonable adverse effects on human health 

or the environment. Additionally, it is a FIFRA violation to use a pesticide in a way that is 

inconsistent with the label. 

Assessment of Risk to Human Health 

The toxicology database for oxathiapiprolin is complete. In the oral and dermal guideline 

toxicity studies, including subchronic, chronic, neurotoxicity, and immunotoxicity studies, no 

treatment related effects were seen at doses up to the limit dose. No treatment related effects 

were observed in maternal or fetal animals in rat or rabbit developmental toxicity studies. 

Treatment related effects were observed in offspring animals in rat reproduction studies. 

However, these effects were only observed at doses above the limit dose. Such high doses are not 

relevant for human health risk because human exposure at this level is not anticipated in 

conjunction with the use directions on the approved product labels. 

There was no evidence of carcinogenicity in cancer studies with rats or mice. Oxathiapiprolin is 

classified as "not likely to be carcinogenic to humans." There is no mutagenic concern for 

oxathiapiprolin including its metabolites. An inhalation toxicity study was not submitted. 

However, in consideration of all other available data and through a weight of evidence (WOE) 

approach, EPA concluded that the inhalation study is not required for oxathiapiprolin. Based on 

the lack of toxicity for oxathiapiprolin across the database, the inhalation toxicity study has 

therefore been waived. 

Due to the lack of toxicity observed in the oxathiapiprolin database, toxicological endpoints and 

POD were not evident in the data for oxathiapiprolin. Therefore, a quantitative risk assessment 

approach which uses endpoints was not needed and, instead a qualitative human health risk 

assessment was conducted to support the uses. This includes assessment of dietary, residential, 

and occupational (handler and post-application) risk estimates. 

In acute toxicity studies, exposure to oxathiapiprolin resulted in low toxicity via the oral, dem1al, 

and inhalation routes of exposure (Toxicity Category IV). Oxathiapiprolin was not a dermal or 

eye irritant, or a skin sensitizer. Based on the acute toxicity of the technical active ingredient the 

Re-Entry Interval (REI) would be12-hours based on the Worker Protection Standard. The 

company proposed a 4-hour REI which is the lowest REI allowed on any label. The Agency 

agreed that a 4-hour REI is appropriate here because this active ingredient meets the criteria of 1) 

an active ingredient with low toxicity for acute dermal, inhalation toxicity, primary skin 

irritation, and primary eye irritation; 2) the active ingredient is not a dennal sensitizer; 3) the 

active ingredient is not a cholinesterase inhibitor; 4) there are no known reproductive, 

developmental, carcinogenic, or neurotoxic effects known; and 5) there is no adverse incident 

information (illness or injury reports) related to post-appli cation exposures. The Personal 

Protective Equipment (PPE) statements on the approved labels require handlers to wear baseline 

clothing (i.e., long sleeved shirt, long pants, shoes plus socks). 

The residue chemistry database is complete, including adequate analytical methods; metabolism 

in target crops, rotational crops, and livestock; storage stability; residues from field trials; and 

Page 4 of12 
residues in processed commodities. All residue study results are supported by adequate storage 

stability data. The field trial studies were conducted using the proposed analytical enforcement 

method. 

Assessment of Risks to the Environment 

Environmental Fate 

Oxathiapiprolin is characterized by a relatively low water solubility with low potential for 

volatili zation from dry/wet and water surfaces. The octanol/water partition coefficient suggests 

that the chemical has the potential to bio-concentrate in aquatic organisms such as fish. 

Oxathiapiprolin is not expected to be affected by hydrolysis, aqueous photolysis, and photolysis 

in soil and anaerobic soil metabolism. The chemical is expected to be relatively persistent in the 

soil and water sediment systems. In these soil and water sediment systems, bio-transformation/biodegradation are the major processes that are expected to affect the fate of oxathiapiprolin. 

Ecological Effects 

Because of its low solubility, oxathiapiproli n did not demonstrate acute or chronic effects of 

concern to freshwater and estuarine/marine fish. Chronic Risk Quotients (RQ) to freshwater 

sediment-dwelling invertebrates were estimated to be 2. 72 which exceeded the Level of Concern 

(LOC) of 1.0 when calculated from sediment based toxicity endpoints. However, the chronic LOC 

was not exceeded for any of the approved uses when the RQs were estimated using pore water or 

water column based toxicity endpoints. To further characterize these findings, it is noted that 

separate spiked-water and spiked-sediment system sediment toxicity studies yielded sediment and 

pore water-based toxicity endpoints. The endpoints from the spiked sediment system are 

approximately an order of magnitude less than those determined from the spiked water system. 

Consequently, there were chronic risk estimates above the level of concern to sediment-dwelling 

invertebrates when using endpoints derived from the spiked sediment system. 

Although no study is available to characterize the toxicity to estuarine/marine organisms, the 

current suite of data for water column invertebrates indicate that estuarine/marine organisms are 

not disproportionately more sensitive than freshwater organisms. Additionally, as indicated above, 

the two chronic freshwater sediment toxicity studies indicate a level of risk below the level of 

concern for most of the uses. For the uses that do exceed the chronic level of concern, the 

exceedances are marginal. Longer term 21 -day freshwater invertebrate sediment toxicity studies, 

as opposed to the shorter guideline subchronic l 0-day toxicity studies, were submitted and 

classified as supplemental. The Agency assumes a similar level of risk to estuarine/marine 

sediment-dwelling organisms. Therefore, no further studies characterizing the toxicity to 

freshwater or estuarine/marine sediment-dwelling invertebrates are needed as they are determined 

to have li ttle overall added value to the cunent risk picture. 

There were no LOC exceedances of listed and non-listed species of aquatic plants for the uses of 

oxathiapiprolin. No acute and chronic avian and mammal LOCs are exceeded, thus, risk to birds 

(and their surrogates) and mammals are not expected. Despite the environmental fate data 

indicating that oxathiapiprolin has the potential to bio-concentrate in aquatic organisms such as 

fish, there was no acute or chronic risk above the LOC indicated for birds and mammals consuming 

Page 5 of 12 
oxathiapiprolin-containing aquatic taxa. This is due primarily to oxathiapiprolin's low acute and 

chronic toxicity to birds and mammals. 

No risk above the LOC to terrestrial plants are expected. The highest application rates tested on 

plants, which was more than twice the highest approved label application rate for all uses of 

oxathiapiprolin, did not elicit a toxicity endpoint at or above the 25% trigger level. The no-adverse 

effect concentration (NOAEC) also exceeded the maximum application rate, reinforcing the 

conclusion of no risk expected for both listed and non-listed species of terrestrial plants. 

The results of the Tier I risk assessment to adult honeybees via direct contact and oral exposure 

resulting from foliar and soil applications, respectively, indicate all RQs fall below the terrestrial 

invertebrate acute LOC of 0.4. A Tier II semi-field bee study was conducted which examines 

effects from the larvae stage through pupation, to adults in an outdoor flight cage where bees are 

exposed to oxathiapiprolin-treated blooming plants. This study indicates that while there were 

reductions in survival at Days 12 and 13 after application, as well as reductions in flight intensity 

on the day of application, the bees recovered from these effects during the course of the 25 day 

study. This is indicated when the entire study interval was considered, all response variables 

related to colony health, survival, and foraging behavior were similar to controls. Based on the 

results of the Tier I honey bee assessment which indicated no LOC exceedances (i.e. acute contact 

and oral risk to adult honey bees), and Tier II semi-field study which indicated honey bee colonies 

showed recovery in multiple response variables, the proposed uses of oxathiapiprolin are not 

expected to significantly impact honey bees at the colony level. Therefore, at this time, no 

additional bee studies are needed. 

The ecological risk assessment determined that for brassica vegetables, bulb vegetables, leafy 

vegetables, peas, tobacco and turf, there were no acute or chronic LOC exceedances of any taxa 

assessed. Thus, a "no effect finding" can be made for listed species. For all other uses that 

include cucurbit vegetables, fruiting vegetables, ginseng, tuberous vegetables, and ornamentals, 

there was at least one scenario assessed for which there was an exceedance of LOC (RQs range 

from 1.0 I to 2. 72) and the taxa of concern were freshwater sediment dwelling invertebrates 

exposed to oxathiapiprolin on a chronic basis. It is noted that for the tuberous vegetable use 

scenarios that were assessed, the highest RQ estimated was l.O 1, negligibly above the chronic 

LOC of 1. For the fruiting vegetables use scenarios, the highest RQ estimated was 2.72, 

marginally above the chronic LOC of I. 

Alternatives 

According to information provided by the registrants, use of oxathiapiprolin could be expected to 

be an alternative, based on the pest spectrum, to existing pesticides which contain Chlorothalonil, 

Mancozeb, Zoxamide, Mandipropamid, Difenoconazole, Dimethomorph, Cyazofamid, 

Fluazinam, Fluopicolide, and Cymoxanil. 

Benefits 

Oxathiapiprolin met the criteria for reduced risk status for all the approved food and non-food 

uses. It is a broad-spectrum fungicide with preventative, residual, systemic, eradicative, and 

Page 6 of 12 
antisporulant properties for foliar and soil-borne fungal diseases. Oxathiapiprolin exhibits a 

unique mode of action. lts unique mode of action suggests that it may play a role in resistance 

management. It can be used as part of an integrated disease control program with fungicides of 

other modes of action that can be part of a resistance management strategy for the approved 

crops. Resistance management directions on the agricultural labels include the limitation of no 

more than two sequential applications and use of effective chemical alternatives in rotation 

programs. Utilization of integrated pest management programs is also encouraged on the 

approved labeling. It is registered for use as a fungicide for protection of crops against difficult 

to control diseases caused by Oomycetes group of fungi (i.e. downy mildew and late blight). The 

maximum yearly application rate is 0.5 lbs./A, which could result in a reduction of the pesticide 

loading in the environment compared to certain registered alternatives. Benefits might also be 

recognized for oxathiapiprolin treatments on registered crops with minor pesticide uses (such as 

ginseng and yams). The use of oxathiapiproli n could offer benefits as a tool in integrated 

fungicide program to faci litate the season-long control of specific fungal pest and extending the 

lifespan of many currently registered fungicides. From a worker safety standpoint, and based on 

the toxicity of the pesticide, agricultural products will have a 4 hour REI, which is the shortest 

period for any agricultural pesticides. ln consideration of the toxicological information on 

oxathiapiprolin compared to several registered alternatives, oxathiapiprolin presents a favorable 

human health and ecological hazard profi le. 

Public Comments 

The Notice of Receipt for this new chemical was published in the Federal Register on April 18, 

2014 with a non-substantive correction published June I L 2014 for registration of 

oxathiapiprolin products and a public comment period of 30 days was announced. No comments 

were received specifically pertaining to oxathiapiprolin. 

On May 23, 2014, the EPA published a Notice of filing in the Federal Register announcing the 

receipt of the initial fi ling ofthe oxathiapiprolin petition DuPont submitted under the FFDCA 

requesting the establishment of regulations for tolerances of oxathiapiprolin on various 

commodities. On July 17, 2015, a correction to this Notice of Filing was published by adding the 

missing requested entry for dried fruiting vegetable. Both publications also announced a public 

comment period of 30 days and no comments were received. 

The EPA announced the proposed decision of the unconditional registration of oxathiapiprolin 

on June 10, 2015, and held a public comment period for 30 days, closing on August 9, 2015. The 

Agency received two comments to the docket (EPA-HQ-OPP-2014-0114). These comments and 

the Agency's response are summarized later in this document. 

Regulatory Decision 

EPA reviewed 411 studies as well as other infonnation submitted to support the approved uses 

for oxathiapiprolin. Because no toxicological endpoints were evident after reviewing the 

complete database, a qualitative (no endpoints generated) human health risk assessment was 

conducted. The assessment concluded that the requested uses pose no human health risks. For 

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future MRL global hannonization purposes. the Agency is setting tolerances for the approved 

uses. 

Oxathiapiprolin received a reduced risk classification and meets the low toxicity criteria 

published in the Federal Register on May 3. 1995. stated in Pesticide Registration Notice 95-3, 

and provided in EPA Label Review Manual (revised April2015). Therefore it is qualified for a 

4-hour REI. which is the lowest REI allowed on any label. 

A quantitative ecological risk assessment was conducted and found that no acute and chronic 

LOC were exceeded for all taxa assessed with the exception of chronic risk to freshwater 

sediment-dwe lling invertebrates for some registered uses. 

In addition to the reduced risk classification received for this class of chemistry, EPA believes 

that the benefit of adding a novel mode of action to the existing class of fungicides is important 

as part of a resistance management progran1 for foliar and soil-borne fungal diseases; refer to the 

Benefits section for additional information. 

Therefore, the Agency has approved the registration of the five products which met the FIFRA 

safety standard and the minimal risk found (ie. sediment dwelling invertebrates) associated with 

certain uses is outweighed by the benefits of the use of these products. No additional data are 

being required for registration. Therefore, EPA unconditionally registered five oxathiapiprolin 

products under Section 3(c)(5) of FIFRA. 

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

Registration Notices and final labeling can be found in the regulatory docket (Document TO: 

EPA-HQ-OPP-2014-0114). 

Comments to the Agency's Proposed Regulator·y Decision 

Summary of Comments Supporting the Agency's Proposed Decision 

Two comments were received from members of the public regarding the registration of 

oxathiapiprolin. These two comments can be found in the docket. 

Summarv of Comments submitted bv Center for Biological Diversity (CBD); comment # 

EPA-HQ-OPP-2014-0114-0017. The following a re excerpts of the comments submitted by 

CBD. The full submission can be found in the docket. 

"The registration of Oxathiapiprolin prior to consultations with the U.S. Fish and Wildlife 

Service and National Marine Fisheries Service represents a clear violation of the ESA. 

According to EPA. '·taxa of concern were freshwater sediment dwelling invertebrates exposed to 

oxathiapiprolin on a chronic basis." A decision to register Oxathiapiprolin prior to the 

completion of consultations would be arbitrary and capricious. a violation of the Federal 

Insecticide, Fungicide, and Rodenticide Act, and a violation of the Endangered Species Act. 

Accordingly. the Center opposes the registration of Oxathiapiprolin at this time. 

Page 8 of 12 
"EPA has an independent duty Under the Endangered Species Act to Consult with the U.S. Fish 

and Wildlife Service and National Marine Fisheries Service on the Registration of any New 

Active Ingredient or approval of any end-usc product that May Affect Protected Species." 

''Section 7(a)(2) of the Endangered Species Act ("ESA") requires that '"each federal agency 

shall, in consultation with and with the assistance of the Secretary, insure that any action 

autho rized, funded , or carried out by such agency is not likely to jeopardize the continued 

existence of any endangered species or threatened species or result in the destruction or adverse 

modification of habitat of such species which is determined by the Secretary ... to be critical.·· 

Under Section 7(a)(2), the EPA must consult with the U.S. Fish and Wildlife Service and 

National Marine Fisheries Service (collectively the ·'Services") to determine whether its actions 

will jeopardize listed species' survival or adversely modify designated critical habitat, and if so, 

to identify ways to modify the action to avoid that result. Under the Services' joint regulations 

implementing the ESA, an action agency such as the EPA must initiate consultation under 

Section 7 whenever its action ·'may affect'' a listed species or critical habitat. Only where the 

action agency determines that its action will have .. no effect" on listed species or designated 

critical habitat is the consultation obligation lifted. The consultation requirement applies to any 

discretionary agency action that may affect listed species. The EPA may decline to register a 

pesticide active ingredient or end-use product if'"when used in accordance with widespread and 

commonly recogni zed practice'· the pesticide would result in "unreasonable adverse effects on 

the environment.'. Accordingly, the EPA's registration of any pesticide represents a 

discretionary action that clearly falls within the ESA's consultation requirement." 

··Given the results of its ecological risk assessment for Oxathiapiprolin. the EPA must begin the 

informal co nsultatio n process with the Services and work towards the preparation of a 

nationwide biological assessment of Oxathiapiprolin. Section 7(d) of the ESA provides that once 

a le deral agency initiates consultation on an action under the ESA. the agency .. shall not make 

any irreversible or irretrievable commitment or resources with respect to the agency action whi ch 

has the etTect of forec losing the f01mulation or implementation of any reasonable and prudent 

alternative measures whi ch would not violate subsection (a)(2) of this section.'· The purpose or 

Sectio n 7(d) is to maintain the environmental status quo pending the completion of consultation. 

Sectio n 7(d) prohibitions remain in effect throughout the consultation peri od and until the EPA 

has satisfied its o bligatio ns under Section 7(a)(2) that the action will not result in jeopardy to the 

species or adverse modificatio n of its critical habitat. An active ingredient cannot be registered 

for use prior to the completion of the consultation process. The registration of an active 

ingredient prio r to the completion of consultations would represent an irreversible and 

irretrievable commitment of resources. and vlould violate the basic requiren1ent of the ESA that 

each agency o f the federal government insure that their actions do not jeopardize listed species or 

adversely modify critical habitat.·• 

··Furthermore, the pro posed labels for Oxathiapiprolin allow applicators to mix the 

Oxa thiapipro lin e nd-use products with othe r pestic ide products. Given the potential 

synerg istic a nd additive effects of mixing pestic ides. a nd the large range of unce rtainty 

regarding the cfTec ts of mixing Oxathiapiproli n with a n enormo us suite or other pesticide 

products a lready o n the market. such a permissive labe l clearly represents a failure of the 

Page 9 of 12 
EPA to insure its actions will not jeopardize listed species." 

EPA/Agency response: 

The Agency has been working collaboratively and actively with the United States Fish and 

Wildlife Service (USFWS) and the National Marine Fisheries Service (NMFS or "Services") to 

design a framework for efficiently completing the consultation process for pesticide actions in 

accordance with the Endangered Species Act (ESA). The Agency is focusing most of its 

resources for assessing impacts to listed species on the Agency's registration review program for 

cun·ently registered or existing pesticides. This allows the Agency to focus on chemicals with 

higher risk, i.e., the "worst first", resulting in the greatest potential benefits for listed species. 

The EPA believes that, as a general matter, currently registered and existing pesticides may 

present a greater degree of risk to listed species than most new chemistries coming to market, 

and that it is therefore environmentally preferable in most circumstances for the EPA to assess 

the impacts of existing pesticides sooner in the process than newer pesticides that are designed to 

compete with more risky alternatives. The Agency does not believe the environment or the 

public would be best served by delaying the registration of oxathiapiprolin to complete 

consultation. In fact, EPA has made a "no-effects" determination for most of the uses approved 

in this registration decision and reached the conclusion that the overall ecological risks of 

oxathiapiprolin are generally low when compared to the LOCs and other fungicides. 

Additionally, the EPA has also negotiated with our partner agencies to phase-in interim scientific 

approaches over time. In November 2013, EPA, USFWS, NMFS, and the US Department of 

Agriculture (USDA) released a white paper containing a summary of their joint interim 

approaches for assessing risks to listed species from pesticides. These interim approaches were 

developed jointly by the agencies in response to the National Academy of Sciences (NAS) 

recommendations, and reflect a conunon approach to risk assessment shared by the agencies as a 

way of addressing scientific differences between the EPA and the Services. Details of the joint 

interim approaches are contained in the November 1, 2013 white paper, Interim Approaches for 

National-Level Pesticide Endangered Species Act Assessments Based on the Recommendations 

of the National Academy of Sciences April 2013 Report. The EPA, USFWS and NMFS are 

continuing to develop and work toward implementation of the interim approaches to assess the 

potential risks of pesticides to listed species and their designated critical habitat, and will apply 

these approaches to initial consultations and, based upon the experience gained with these 

approaches as well as any new science that may develop, modify procedures as appropriate. 

With respect to the evaluation of oxathiapiprolin specifically and as explained in this document, 

current data indicate that the ecological risks presented by uses of oxathiapiprolin are generally 

low. A "no effect" determination was reached for the I is ted species for most of the assessed crop 

uses. For the uses that include cucurbit vegetable, fruiting vegetables, ginseng, tuberous 

vegetables, and ornamental, there was at least one scenario assessed (freshwater sediment 

dwelling invertebrates) for which there was a marginal risk. Therefore, there are potential risks 

of direct effects to listed freshwater sediment dwelling invertebrates and potential indirect effects 

to fish and other aquatic taxa that consume freshwater benthic invertebrates. Potential direct 

effects on freshwater sediment dwelling invertebrates from the uses of oxathiapiprolin may be 

associated with the modification of Primary Constituent Elements of designed critical habitats, 

where such designations have been made. However, it is premature to make an effects 

Page 10 of 12 
determinations for listed species of concern until further scientific analysis and refinements are 

conducted, based on recommendations received from the National Academy of Science's 

National Research Counci l April 2013 report, available at 

http://wwvv.nap.edu/catalog.php?record id= 18344 

To the extent that the EPA receives new information indicating that oxathiapiprolin may pose a 

greater risk to listed species than indicated by the existing scientific database for this pesticide, 

the EPA will re-evaluate the tern1s of registration and detern1ine whether use restrictions to 

protect listed species are necessary. The Agency is currently working to prioritize its 

consultation activities with the Services and will evaluate the appropriate timing and scope of 

any necessary consultation on oxathiapiprolin in connection with those efforts. Additionally, if 

evidence from incidents or field observations suggest that current label language is not providing 

adequate protection to non-target organisms, county use limitations could be required. To the 

extent that county-specific label mitigation is needed, the EPA would use the web application 

.. Bulletins Live Two" (BLT)" to set fourth geographically-specific pesticide use limitations for 

the protection of threatened and endangered species and their designated critical habitat. BL T 

can be found at hnp:l/ww"' .cpa.gov/oppfead I /cndanger/bulletins.htm 

Regarding synergistic effects, the Agency does not routinely include a separate evaluation of 

mixtures of active ingredients, rather the EPA risk assessments focus on individual chemicals. 

The oxathiapiprolin end-use products do not contain multiple active ingredients. However, tank 

mixing is a common practice in agriculture. In an instance where a user is tank mixing products, 

the pesticide applicators must follow the requirements of each label. If there is any unique 

requirement more (most) restrictive oflabel limitations and precautions, the more restrictive 

label must be followed. 

Summarv of Comments submitted by private citizen; comment # EPA-HQ-OPP-2014-

0114-0005. The following are excerpts of the comments submitted by a private citizen. The 

full submission can be found on the docket. 

··1 hope you will reconsider before loosening tolerances on any food items, imported or domestic, 

or agricultural products destined for food animals. You list those concerned as being involved in 

crop or animal production, food or pesticide manufacturing, but you seem to forget the most 

important party concerned: the American citizens you are supposed to be protecting." and " ... 

These petitions address many different pesticides (a term that includes insecticides, herbicides, 

fungicides, etc.) and many different products. I am making an argument that regulations of these 

dangerous chemicals - all of them- should be significantly tightened. It is an issue of 

environmental justice that our youngest citizens - our children- are disproportionately exposed 

to health risks."' 

"The President's Cancer Panel (PCP) Report of20 10 and the American Academy ofPediatrics 

(AAP) in 2013 assign much ofthe blame for rising cancer rates in children to virtually 

unregulated pesticide exposures. The CDC Biomonitoring Project shows that every American is 

contaminated with hundreds of toxic chemicals. even before birth (CDC, 2005). 

It would be unconscionable to continue ignoring the epidemiologic data. which is superior to 

animal studies in assessing harm. The President's Cancer Panel is even more explicit. The 

President's Cancer Panel, appointed by President Bush, whose 2008-2009 Annual Report 

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reviewed 454 sources and found that many cancers. perhaps most, could be prevented by 

cleaning up the environment in just a few high-impact ways. In the letter to the President that 

precedes the report, they could scarcely have stated the alarm their findings raised more 

strongly:" 

EPA/ Agency response: 

The existing legal framework provided by section 408 of FFDCA states that tolerances may be 

set when persons seeking such tolerances or exemptions have demonstrated that the pesticide 

meets the safety standard imposed by that statue. When new or amended tolerances are 

requested for residues of a pesticide in food or feed. the Agency, as is required by Section 408 of 

FFDCA, estimates the risk of the potential exposure to these residues by performing an 

aggregate risk assessment. Such a risk assessment integrates the individual assessments that are 

conducted for food , drinking water, and residential exposures. Additionally, the Agency, as is 

fUJther required by Section 408 of the FFDCA, considers available information concerning what 

are termed cumulative toxicological effects of the residues of that pestic ide and of other 

substances having a common mechanism of toxicity. Pursuant to its authority under the FFDCA, 

the Agency conducted a comprehensive assessment of oxathiapiprolin. which considered both 

exposure and toxicological effects-including an assessment on the carcinogenic potential of 

oxathiapiprolin-in reaching a conclusion as to whether or not the reasonable certainty of no harm 

decision can be made. Based on its assessment of the available data, the Agency has found that 

there is a reasonabl e certainty of no harm to humans, with special emphases on infants and 

children sensitivity, from aggregate exposure to oxathiapiprolin based on a complete 

toxicological database and the potential exposure levels. 

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