USCA Case #21-1079 Document #1888440 Filed: 03/03/2021 Page 1 of 56
`
`IN THE UNITED STATES COURT OF APPEALS
`FOR THE DISTRICT OF COLUMBIA CIRCUIT
`
`FARMWORKER ASSOCIATION OF
`FLORIDA, ENVIRONMENTAL
`WORKING GROUP, and CENTER FOR
`BIOLOGICAL DIVERSITY,
` Petitioners,
`
` v.
`
`UNITED STATES ENVIRONMENTAL
`PROTECTION AGENCY,
` Respondent.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`No.
`
`21-1079
`
`PETITION FOR REVIEW
`
`Pursuant to Section 16(b) of the Federal Insecticide, Fungicide, and
`
`Rodenticide Act (FIFRA), 7 U.S.C. § 136n(b), Rule 15 of the Federal Rules of
`
`Appellate Procedure, and Circuit Rule 15, Farmworker Association of Florida,
`
`Environmental Working Group, and Center for Biological Diversity hereby
`
`petition the Court for review of Respondent United States Environmental
`
`Protection Agency’s Order registering the use of the pesticide aldicarb on oranges
`
`and grapefruit in Florida, as set forth in its “Registration Decision for the Uses on
`
`Oranges and Grapefruit in Florida, Aldicarb” (Jan. 12, 2021) (Attachment 1),
`
`amendments to the aldicarb product labels for MEYMIK TECHNICAL (EPA Reg.
`
`No. 87895-2) (Attachment 2) and AGLOGIC 15GG (EPA Reg. No. 87895-4)
`
`1
`
`

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`USCA Case #21-1079 Document #1888440 Filed: 03/03/2021 Page 2 of 56
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`(Attachment 3), and registration of a new product, AgLogic 15GG-OG (EPA Reg.
`
`No. 87895-7) (Attachment 4).
`
`Respectfully submitted this third day of March, 2021,
`
`JONATHAN EVANS (DC Cir Bar #53186)
`Center for Biological Diversity
`1212 Broadway, Suite 800
`Oakland, CA 94612
`Tel: (510) 844-7100 x318
`Fax: (510) 844-7150
`jevans@biologicaldiversity.org
`
`s/ Stephanie M. Parent
`STEPHANIE M. PARENT (DC Bar #56357)
`Center for Biological Diversity
`P.O. Box 11374
`Portland, OR 97211
`Tel: (971) 717-6404
`Fax: (503) 283-5528
`sparent@biologicaldiversity.org
`
`Attorneys for Petitioners Farmworker
`Association of Florida, Environmental
`Working Group, and Center for Biological
`Diversity
`
`2
`
`

`

`USCA Case #21-1079 Document #1888440 Filed: 03/03/2021 Page 3 of 56
`
`IN THE UNITED STATES COURT OF APPEALS
`FOR THE DISTRICT OF COLUMBIA CIRCUIT
`
`FARMWORKER ASSOCIATION OF
`FLORIDA, ENVIRONMENTAL
`WORKING GROUP, and CENTER FOR
`BIOLOGICAL DIVERSITY,
` Petitioners,
`
` v.
`
`UNITED STATES ENVIRONMENTAL
`PROTECTION AGENCY,
` Respondent.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`21-1079
`No.
`
`RULE 26.1 DISCLOSURE STATEMENT
`
`Pursuant to Fed. R. App. P. 26.1 and Circuit Rule 26.1, Petitioners make the
`
`following disclosures:
`
`Farmworker Association of Florida has no parent companies, and no
`
`publicly held company has a ten percent or greater ownership interest in
`
`Environmental Working Group.
`
`Environmental Working Group has no parent companies, and no publicly
`
`held company has a ten percent or greater ownership interest in Environmental
`
`Working Group.
`
`Center for Biological Diversity has no parent companies, and no publicly
`
`held company has a ten percent or greater ownership interest in Center for
`
`Biological Diversity.
`
`1
`
`

`

`USCA Case #21-1079 Document #1888440 Filed: 03/03/2021 Page 4 of 56
`
`Respectfully submitted this third day of March, 2021,
`
`JONATHAN EVANS (DC Cir Bar #53186)
`Center for Biological Diversity
`1212 Broadway, Suite 800
`Oakland, CA 94612
`Tel: (510) 844-7100 x318
`Fax: (510) 844-7150
`jevans@biologicaldiversity.org
`
`s/ Stephanie M. Parent
`STEPHANIE M. PARENT (DC Bar #56357)
`Center for Biological Diversity
`P.O. Box 11374
`Portland, OR 97211
`Tel: (971) 717-6404
`Fax: (503) 283-5528
`sparent@biologicaldiversity.org
`
`Attorneys for Petitioners Farmworker
`Association of Florida, Environmental
`Working Group, and Center for Biological
`Diversity
`
`2
`
`

`

`USCA Case #21-1079 Document #1888440 Filed: 03/03/2021 Page 5 of 56
`
`Attachment 1
`
`

`

`USCA Case #21-1079 Document #1888440 Filed: 03/03/2021 Page 6 of 56
`
`Registration Decision for the Uses on Oranges and
`Grapefruit in Florida, Aldicarb
`
`('"' # jlfJ A
`c:.-o\ !1u!'~Date:2021.01.1 2
`
`Digitally signed by
`EDWARD MESSINA
`
`Approved by:
`14:58:21 -05'00'
`Ed Messina, Esq., Acting Director
`Office of Pesticide Programs
`US Environmental Protection Agency
`
`Date: January 12,2021
`
`

`

`USCA Case #21-1079 Document #1888440 Filed: 03/03/2021 Page 7 of 56
`
`Table of Contents
`
`SUMMARY ............................................................................................................................ 3
`I.
`II. REQUESTED ACTION .......................................................................................................... 4
`III. USE PROFILE ........................................................................................................................ 4
`IV. EVALUATION ....................................................................................................................... 5
`A.
`Assessment of Risks to Human Health ............................................................................ 5
`1. Toxicology Profile ................................................................................................................... 5
`2. Percent Crop Treated Analysis ................................................................................................ 6
`3. Dietary (Food + Water) Risks ............................................................................... : ................. 6
`4. Occupational Handlers Risks .................................................................................................. 7
`5. Residential Risks ..................................................................................................................... 8
`6. Aggregate Risk ............... .-........................................................................................................ 8
`7. Cumulative Risk ...................................................................................................................... 8
`B.
`Assessment of Environmental and Ecological Risks ....................................................... 9
`1. Environmental Effects ........................................................................................................... 10
`C.
`Alternatives and Benefits Assessment ........................................................................... 11
`V. PUBLIC COMMENTS ......................................................................................................... 12
`VI. REGULATORY DECISION ................................................................................................ 12
`A.
`Rationale and Risk Mitigation ........................................................................................ 13
`B.
`Terms and Conditions of Registration ........................................................................... 14
`Registration Expiration ............................................................................................................. 14
`C.
`Label Requirements ......................................................................................................... 16
`VII. SUPPORTING DOCUMENTS ............................................................................................ 18
`
`2
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`

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`USCA Case #21-1079 Document #1888440 Filed: 03/03/2021 Page 8 of 56
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`I.
`
`SUMMARY
`
`'rhe U.S. Environmental Protection Agency (referred to hereafter as "the EPA" or "the Agency")
`is conditionally registering, under section 3(c)(7)(B) of the Federal Insecticide, Fungicide and
`Rodenticide Act (FlFRA), uses for two existing pesticide registrations containing the active
`ingredient aldicarb. The uses registered with this decision include the follO\ving crop/use sites,
`restricted to the state of Florida: oranges and grapefmit. These uses amend both the
`manufacturing use product, MEYMIK TECHNICAL (I";PA Reg. No. 87895-2; 96% aldicarb),
`and the granular end-usc product, AGLOGIC 15GG (EPA Reg. No. 87895-4; 15% aldicarb).
`During the evaluation of the these products, the Agency requested the submission of a separate
`new product (EPA Reg. No. 87895-7; 15% aldicarb) vvhich is labeled for use only on orangcs
`and grapefruit in Florida, which will allow EPA to better monitor the compliance with the terms
`of these registrations. The Agency is amending the existing products to add these uses under
`FffRA 3( c)(7)(B) as time-limited registrations with a sales and distribution cap, and an
`expiration date as noted in the terms of registration. The additional Florida-only product for usc
`on oranges and grapeiruit will-then be registered under FIFRA 3(c)(7)(A). In order to meet
`agency safety standards, the EPA is requiring a sales and distribution cap of 2.5 million pounds
`of product on these registrations limiting the number of acres that can be treated (i.e., 100,000
`acres). Furthennore, the product must be soil incorporated (3 inches or greater) to reduce runoff
`potential and potential for wildlife exposure, and well set-backs of 500 ft. to 1000 ft. (based on
`soil types as identified by the United States Department of Agriculture (USDA) Natural
`Resources Conservation Service) to ensure that the product does not contaminate drinking water
`sources. Additional conditions of these registrations arc thc submission of confiIDlatory
`pollinator data identified in the recent interim registration review decision, a robust registrant
`stewardship plan including applicator training and monitoring, and enhanced reporting of where
`and how much product is applied.
`
`Aldicarb is a systemic carbamate used to control certain insects, mites, and nematodes and is
`currently registered for use on cotton, dry beans, peanuts, soybeans, sugar beets, and sweet
`potatoes. Aldicarb is fOIDmlated as a granular pesticide and is usually applied early in the
`growing season (pre-plant, at-plant, or early post-emergent) using ground application equipment.
`Aldiearb may only be applied as a soil treatment by any of the follm:ving methods: sidedress,
`bandiT-band, and in-furrow treatment. Aldicarb is a Restricted Usc Pesticide (RUP) and may
`only be purchased and applied by certified applicators or persons under their direct supervision.
`Aldicarb use on citrus crops and potatoes was voluntarily phased out in 2010 by Bayer, thc initial
`registrant. However, the tolerances on citrus commodities remain to allow for the legal
`importation of crops treated with aldicarb. Since the proposed use on oranges and grapcfmit is
`similar to the previously registered use, the cumulative exposure to the class ofNMC pesticides
`through food would not be significantly impacted by the proposed orange and grapefruit uses for
`aldicarb.
`
`The Insecticide Resistance Action Committee (IRAC) includes aldicarb in Group lA. These new
`uses (oranges and grapefruit) have been added to the currently registered technical product (EPA
`Reg. No. 87895-2) as time-limited uses subject to the continued uses supported on an cnd-use
`product; as a time-limited supplemental label to the currently registered end-use product (EPA
`Reg. No. 87895-4), for use this application season (which ends on April 30, 2021); and a timc-
`
`3
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`

`

`USCA Case #21-1079 Document #1888440 Filed: 03/03/2021 Page 9 of 56
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`limited registration for the ne"v product registration (EPA Reg. No. 87895-7) for use on oranges
`and grapefruit in Florida, described above, for the following two application seasons. These end(cid:173)
`use products are RUPs based on acute oral, dermal and inhalation toxicity and due to ground
`water contamination and may only be applied by certified commercial applicators or persons
`under the direct supervision of a celtified applicator. The supplemental label for the currently
`registered end-use product may only be used on oranges and grapefmit in Florida and will expire
`at the end of the current application season, April 30, 2021. The new product registration (EPA
`Reg. No. 87895-7), which will not be sold or distributed until after the supplemental label
`expires, will have similar restrictions and limitations; however, in order to facilitate the
`implementation and tracking of the sales and distribution cap, the new product will only be
`registered for the use on oranges and grapefruit in Florida and will expire April 30, 2023. The
`maximum application rate for these end-use products on oranges and grapefruit is 33 lbs. product
`(4.95lbs a.i.)/acre. The label also restricts the lowest application rate to 251bs. product/acre to
`prevent FIFRA 2( ee) use of the product on a greater number of acres. Only one application is
`allowed within the application season of November l5-April 30.
`
`II. REQUESTED ACTION
`
`In April 20 19 the EPA received application from AgLogic, Inc. seeking to register the new uses
`of aldicarb to the end-use prodUCT containing aldicarb (CAS Number 116-06-3) on oranges and
`grapefruit in Florida and Texas. The Agency published the notice of receipt of the application for
`public comment (30 days) on December 7, 2020. During the application review, the registrant
`amended the request and the use was limited by amount of product that can be sold and
`distributed (i.e., 2,500,000 Ibs product) for use during an application season (November 15
`April 30), limited to oranges and grapefruit in Florida, only, and will expire after the third
`application season (April 30, 2023).
`
`HI. USE PROFILE
`
`The proposed use patterns evaluated by the EPA in the assessment of human health risks, the
`assessment of environmental and ccologicaJ risks and biological and economic benefits
`assessment are included in the approved labeling and limited by the tenl1S of registration. These
`products are RUPs and applications may only be made by certified applicators or persons under
`the direct supervision of a certified applicator. The maximum labeled application rate for these
`end-use products on oranges and grapefruit is 33 Ibs. product (4.95Ibs a.i.)/acrc. Only one
`application is allowed within the application season of November 15-April 30. In addition, there
`are several restrictions and prohibitions for these uses on the label that must be adhered to
`including a specified type of application equipment, specific soil incorporation depths (minimum
`of 3 inches) and well set-back distances (minimum 500 feet). To minimize leaching into the
`water systems, the application timing begins November 15 and ends April 30 prior to the Florida
`rainy season. Further details on label restrictions, use patterns and terms of registration ean be
`found on the approved labels (EPA Reg. No. 87895-2, EPA Reg. No. 87895-4 and EPA Reg. No.
`87895-7) posted in the docket (Docket ID: EPA-HQ-OPP-2020-0600) and also in Pesticide
`Product and Label System (PPLS).
`
`4
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`

`

`USCA Case #21-1079 Document #1888440 Filed: 03/03/2021 Page 10 of 56
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`IV. EVALUATION
`
`In evaluating a pesticide registration application, the EPA assesses a wide variety of exposure
`information (i.e., where and how the pesticide is used) and environmental fate (i.e., how the
`chemical will move in the environment) and toxicity studies (i.e., effects on humans and other
`non-target organisms) to determine the likelihood of adverse effects (i.e., risk) from exposures
`associated with the proposed use of the product. Risk assessments are developed to evaluate the
`environmental fate of the compound as well as how it might affect a wide range of non-target
`organisms including humans, terrestrial and aquatic wildlife (plants and animals). In addition, a
`biological and economic benefits assessment (benefits vs. risk) may be conducted. Based on
`these assessments, the EPA evaluates and approves language for each pesticide label to ensure
`the directions for use and safety measures are appropriate to mitigate any potential risk. In this
`way, the pesticide label communicates essential limitations and mitigations that are necessary for
`public safety. It is a FIFRA violation to use a pesticide in a manner inconsistent with its labeling.
`
`The EPA requires a wide range of studies in order to assess a pesticide use scenario. For the new
`uses of aldicarb on oranges and grapefruit in Florida, the database of studies required to support
`the assessment of risk to human health is complete. A summary of the findings of the human
`health risk assessment are discussed below, and further details can be found in the memorandum,
`D453397. Aldicarb: Human Health Risk Assessment in Support of New Uses on Oranges and
`Grapefi-uits in Florida. Nadrchal, et.al. 0110712021 (Docket ID: EPA-HQ-OPP-2020-0600).
`
`A. Assessment of Risks to Human Health 1
`
`1. Toxicology Profile
`
`Aldicarb is highly acutely toxic via the oral, dermal, and inhalation routes of exposure in the
`acute lethality studies (Toxicity Category I). Aldicarb is not considered to be a dennal sensitizer
`and immunotoxicity was not observed in the available toxicity data. The acute toxicity profiles of
`the technical formulation (96% a.i.) and both end-use product formulations (15% a.i.) are
`Toxicity Category I via the oral, dermal and inhalation routes of exposure. Based on these
`toxicity profiles, the signal words are "DANGERJPOISON" for these products.
`
`Aldicarb is classified as Category E, Evidence of Non-Carcinogenicity for Humans, based on the
`lack of evidence of carcinogenicity in rats and mice studies and the absence of a mutagenicity
`concern. A quantitative cancer risk assessment is not required.
`
`The aldicarb human health risk assessment is based on the most sensitive endpoints in the
`toxicity database. The endpoint for all exposure scenarios is red blood cells (RBC)
`acetylcholinesterase (AChEI), and points of departure (PODs) were selected from a human oral
`study. The POD for the acute dietary (all popUlations) exposure scenario was 0.013 mg/kg/day;
`no POD was selected for chronic dietary exposure because the magnitude of AChEI does not
`increase with continued exposure due to the reversibility of AChEI « 24 hours). There are no
`
`lD453397; Aldicarb: Human Health Risk Assessment in Support of New Uses on Oranges and Grapefruits in
`Florida. D. Nadrchal, et.al.; Ol107i2021.
`
`5
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`

`USCA Case #21-1079 Document #1888440 Filed: 03/03/2021 Page 11 of 56
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`chronic toxic effects more sensitive than AChET. The POD selected for the dermal and
`inhalation worker scenarios was also 0,013 mg/kg/day based on the same study.
`
`Since a human study was used to derive the RBC AChEl endpoint, the interspecies uncertainty
`factor is reduced from lOX to IX; the intraspecics uncertainty factor is retained at lOX. A non(cid:173)
`guideline Comparative Cholinesterase Assay (CCA) is available showing pups to be 4.8X more
`sensitive than adult animals for AChEI; thus, a data-derived FQP A safety factor is retained for
`infants and children. No increased susceptibility was observed in fetuses. Because of the rapid
`onset and recovery of the enzyme following carbamate exposure, in contrast to the irreversible
`binding and pennanent inhibition ofthe bound enzyme that occurs following OP exposure, an
`additional safety factor is not warranted for the aldicarb. Therefore, the combined safety factor
`for dietary and aggregate assessment is 48X to assure protection of infants and children. and for
`adult occupational assessment is lOX.
`
`N-methyl carbamates like aldicarb share the ability to inhibit AChE through earbamylation of the
`serine residue on the enzyme lpading to accumulation of acetylcholine and ultimately cholinergic
`neurotox.ieity.
`
`Endpoints used in these analyses can be found in the supporting memorandum.
`
`2. Percent Crop Treated Analysis2
`
`The percent crop treated (PCT), based on the proposed sales and distribution limitation proposed
`by the registrant, allows for a maximum of ~100,OOO total orange and grapefmit acres across
`Florida to be treated with aldicarb atmually while taking into account total US orange and
`grapefruit production and the potential for orange and grapefruit imports to be treated with
`aldicarb. This peT also accounts for a projected decline in Florida orange acreage to estimate
`national PCI' values for the proposed uses on orange and grapefruit in Florida through 2023,
`when the proposed registrations \vould expire. Therefore, the peT used in suppcHi of the orange
`and grapefruit uses will be protective of the actual current acreage treated.
`
`The maximum percent crop treated estimates of orange, 13%; orange juice, 63{%; grapefruit,
`and grapefruit juice, 16% were used in the acute dietary risk assessment. Other residue
`I
`refinements are described in supporting memos.
`
`3. Dietary (Food + Water) Risks3
`
`The acute dietary exposure assessment for aldiearb is highly refined and conducted for food and
`(lssessment incorporated an estimated half .. life f()f RBC AChEl oft\vo
`drinking water.
`hours which is
`on
`from rats and human
`. ,cts.
`EPA refined the 3 .. ute
`
`2 D454270; Aldicarb (PC 11098301) Use on Oranges arid Grapefi'lIit: Benefits, Estimated Percent Crap
`Treated (PCT), Response to Registrant Comments, and Soillilcorporatioll Depth. 1. Hansel, et.a!.; OU07/2021
`3 D453397; Aldicarb: Human Ilea/til Risk Assessment in Support ofNn\l UI'es on Oranges and Grapelruifs in
`Florida. D. Nadrchal, eta!.; 01/07/2021.
`
`6
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`

`USCA Case #21-1079 Document #1888440 Filed: 03/03/2021 Page 12 of 56
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`by
`considers
`occasion
`an
`eating occasion as a source of exposure as opposed to conducting the assessment
`based on the total amount of food consumed throughout the day. This is then used to estimate
`exposures and risks by factoring in the AChEl half-life related to multiple aldicarb dietary
`exposures throughout a day. Pesticide Data Program (PDP) monitoring data for impOlted
`potatoes only were used; residues from domestic potato samples were not included in the
`analysis since use on potatoes is no longer registered in the U.S. Moreover, the PDP monitoring
`data for the affected commodities from the new uses on orange and grapefruit have been further
`refined by the percent crop treated.(PCT) based on the limitation of use on 100,000 acres in
`Florida. Based on these refinements, the probabilistic dietary exposure asscssments for aldicarb
`show that food and water exposures do not exceed the EPA's level of concern for any population
`subgroup at the 99.9111 percentile of exposure, when aldicarb is applied at a minimum soil
`incorporation of 3 inches, minimum well set-backs of 500 ft., and following sales and
`distribution limits for orange and grapefruit. These dietary asscssments show that the general
`U
`popUlation occupies 43% of the acute population adjusted dose (aPAD), while the most
`highly exposed population subgroup, children 1-2 years old, occupies 95% aP.t\D.
`
`4. Occupational Handlers Risks
`
`The aldicarb product label allows for either open pour/open cab applications (with personal
`protective equipment (PPE)) or closed loading/closed cab applications (i.e., engineering
`controls). The granular aldicarb products arc considered low dust materials, due to their
`substrate, and result in reduced exposure levels relative to the high dust fonnulations for which
`exposure data are available for closed loading/closed cab applications. Chemieal- and
`formulation-specific handler exposure data (Iv1RlD 43852501) are available in support of open
`pour/open cab application scenarios for "low dust" aldiearb fonnulations. The EPA relied on the
`chemical-specific data for unit exposures for open pour/open cab applications. For the closed
`loading/closed cab scenarios, the EPA relied on available Occupational Pesticide Handler
`Exposure Data as surrogate data [specifically, the Pesticide Handlers Exposure Database
`(PRED)].
`
`For the open pour/open cab application scenarios, using chcmical-specific unit exposure data,
`representative of a single layer of clothing, gloves, and, for mixer/loaders only, a standard
`filtering facepiecc respirator, there are no combined dennal and inhalation risk estimates of
`concern (i.e., margins of exposure (MOEs) are> 10).
`
`For the closed loading/closed cab application scenruios, using available surrogate PRED unit
`exposure data for engineering controls, all combined dennal and inhalation risk resulted in
`estimates of concern (i.e., MOEs < 10). However, exposure and risk estimates for handlers using
`closed systems are considered overestimates as the PRED surrogate unit exposures are not
`representative of the low dust aldicarb [onnulations. The closed loading scenario data are
`representative ofliquid fonnulations and the closed cab applicator scenario data are
`representative of typical granular fonTIulations. Where exposure exceedances exist, the
`combined risk estimates arc driven by dermal exposure. It should be noted that an assumption of
`100% dermal absorption was used in the demlal exposw-e/risk calculations since an acceptable
`
`7
`
`

`

`USCA Case #21-1079 Document #1888440 Filed: 03/03/2021 Page 13 of 56
`
`dennal absorption study was not submitted. Given that the registered product is a granular
`fonnulatioll, it is unlikely that 100% dennal absorption would occur.
`
`A quantitative occupational post-application dermal assessment was 110t conducted for aldicarb
`since aldicarb is incorporated into the soil and there is limited potential for exposure to workers
`from soil incorporated pesticides. Based on the Agency's current practices, a quantitative n011-
`caneer occupational post-applieation inhalation exposure assessment was not perfonned tor
`aldicarb at this timc. However, if new policies or procedures are implemented, the Agency may
`revisit the need for a quantitative occupational post-application inhalation exposure assessment
`for aldicarb.
`
`5. Residential Risks
`
`There are currently no registered residential uses of aldicarb; thcrefore, a quantitative residential
`handler and post-application assessment was not conducted.
`
`6. Aggregate Risk
`
`In aceordance with the Food Quality Protection Act (FQPA), the EPA must consider and
`aggregate pesticide exposures and risks from three major sources: food, drinking water, and
`residential exposures. In an aggregate assessment, exposures from relevant sources are added
`together and compared to quantitative estimates of hazard, or the risks themselves can be
`aggregated. When aggregating exposures and risks from various sources, the EPA considers both
`the route and duration of exposure.
`
`There are no residential uses of aldicarb. Therefore, aggregate risks include only acute dietary
`contributions. The acute dietary risk estimates for food plus drinking water are not of concem
`when aldicarb is applied to oranges and grapefruit following the use pattem described in Section
`III, which includes minimum soil incorporation of 3 inches, minimum wcll set-backs of 500 ft.
`and no more than 100,000 acres treated (95% of the aPAD for children 1-2 years old, the most
`highly exposed population subgroup).
`
`7. Cumulative Risk
`
`The FQPA requires the Agency to consider the cumulative risks of chemicals sharing a common
`mechanism of toxicity. Aldicarb is a member of the NMC common mechanism group. NMCs
`like aldicarb share the ability to inhibit AChE through carbamylation of the serine residue on the
`enzyme leading to accumulation of acetylcholine and ultimately cholinergic neurotoxicity. This
`shared MOA/AOP is the basis for the NMC common mechanism grouping per OPP's Guidance
`For Identif}'ing Pesticide Chemicals and Other Substance.'.' that have a Common lHechanism of
`Toxici~y (USEP A, 1999). The 2007 Cumulative Risk Assessment (CRA) and the subsequent
`revision used brain AChET in female rats as the source of dose response data for the relative
`potency factors and PODs for each NMC, including aldicarb.
`
`8
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`

`USCA Case #21-1079 Document #1888440 Filed: 03/03/2021 Page 14 of 56
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`Exposure to aldiearb based on the previously active registration on citrus was included in the
`2007 lV-Mcthyl Carbamate Cumulative Risk Asscssment (NMC CRA)4. Since the proposed use
`on oranges and grapcfmit is similar to the previously registered use, the cumulative cxposure to
`the class ofNMC pesticides through food would not be significantly impacted by the proposed
`orange and grapefmit uses for aldicarb. For the 2007 NMC CRA, food exposure to aldicarb was
`estimated based on measured pesticide residues in orange, orange juicc, and grapefmit 5. For the
`1110St sensitive sUbpopulation, childrcn 1-2 years old, the food exposure to aldicarb for these
`citrus foods was minimal for those at high-end of the exposure distribution. Furthennore,
`assuming a 3 inch soil incorporation depth and a minimum 500 ft drinking water well set-backs,
`exposure through drinking water residues resulting from the proposed use would not contribute
`significantly to the cumulative risk. Therefore, no new cumulative assessment is required at this
`time.
`
`B. Assessment of Environmental and .Ecological Risks 6
`
`Ecological risk characterization integrates the results of the exposure and eeotoxicity data to
`evaluate the likelihood of adverse ecological effects. The means of integrating the results of
`exposure and ecotoxicity data is called the quotient mcthod. For this method, risk quoticnts
`(RQs) arc calculated by dividing cxposure estimates by ecotoxicity values, both acute and
`chronic (RQ ,,= Exposures/Toxieity). RQs are then compared to the EPA's levels of concern
`(LOCs). The LOCs are criteria used by the EPA to indicatc potential risk to non-target
`organisms. The criteria indicate whether a pesticide, when used as directed, has the potential to
`cause adverse effects to non-target organisms.
`
`The battery of tests required to assess thc environmental fate and ecological effects of aldicarb is
`sufficient for conducting the risk assessments and developing regulatory dctenninations
`pertaining to the current and proposed uses, but additionally requircd data will help confirm risk
`conclusions and bettcr able the agency to further understand ecological risks from aldicarb's
`lise .. Additional intonnation on the environmental fate profile of aldicarb can bc found in the
`previous risk assessmcnt for agricultural uses (Reregistration Eligibility Decision, USEPA 2006
`and Registration Review Risk Assessment, USEPA 2015 7
`). Previous risk assessments identified
`the lack of Tier I honey bee data as an unccrtainty. In EPA's risk assessment evaluation for the
`proposed use on oranges and grapefruit, EPA conservativcly assessed potential risk to bees using
`
`4 http://itrcweb.orgfFileCabinetiGetFile?fiIeID=6883
`5 USDA's PDP colleets thousanus of foou samples annually and analyzes these samples for residues of hundreds ofpesticiues.
`Residue data from PDP was used to estimate food exposure for the NMC eRA. PDP found a number of delectable residues of
`aldicarb or its metabolites in grapefruit, orange. and orange juice. More specifically, the number of detectable residues (and years
`sampled) were 4 out of 1462 grapefruit samp'es with concentrations <= 0.063 ppm (2005-2006); 13 out of 4864 orange sample
`0.025 ppm (1994-1996, 2000-2001, & 2004-2005); and 46 out of2879 orange juice samples with
`with concentration
`concentrations
`0.035 ppm (1997-1998 & 2004-20061-
`(, D453398; .11dicarb-- Proposed Section 3 Ni'»' U\'e Registration for Oranges and GrapejtNil Crops in Florida. W. Wagman,
`etal.; 01/07/2021
`7 (JSEPA. 2006. EFED A.ldicarb Ecological Risk Assessment (RED). EnvirOlmlentai Fate and Effects Division, Oftlce of
`Pesticide Programs, Office of Prevention, Pesticides, and Toxic Substances. Washinlo'ion, D.C. September, 2006.
`USEP A. 2015. Preliminary Ecological Risk Assessment for Registration Review of Aldicarb. Environmental Fate and E1Tects
`Division, Office of Pesticide Prof,'fams, Offices ofChemieal
`and Pollution Prevention. Washington, D.C October 6,
`2015. D424563.
`
`9
`
`

`

`USCA Case #21-1079 Document #1888440 Filed: 03/03/2021 Page 15 of 56
`
`the most sensitive available toxicity data for structurally similar surrogate chemicals and
`conservative estimates of exposure based on aldicarb's fatc properties and Tier 1 screening level
`residue modeling. EPA is calling in aldicarb-specific bee toxicity and exposure infomlation in
`order to confiml risk conclusions based on the use of surrogate toxicity data and to refine the risk
`assessment for bces exposed to aldicarb from use on citrus.
`
`1. Environmental Effects
`
`The anticipated effects of