DocketNumber EPA-HQ-OPP

-201 4-0181 www.regulations.gov



# MCPB Final Work Plan Registration Review

Case Number 2365
September 2014

Approved by:**~** 

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## "!;> Richard P. Keigwin, Jr. Director Pesticide Re-evaluation Division

Date:INTRODUCTION This i s the Env ir o nmental Protection Agency's (EPA or the Age n cy) Final Work P lan ( FWP ) for the registration r eview of MC PB. This work plan addresses public co mment s recei ve d concerning th e Pr e liminary Work Plan (PWP), whic h was posted in the MCPB regi strat ion review docket (E P A -HQ-OPP-2014-0181). MCPB is a postemergence phenoxy herbicide r eg i stered for u se to control annual and perennial broadl eaf weeds in p eas, s pearmint , and p e ppermint. MCPB is not registered for any non-a g ricultur a l u ses . T h e r egis tration review case for MCPB includes M C PB ac id (PC code 019201) and MCPB sod ium sa lt (PC code 019202). The Agency is imp l ementi ng the registration r ev i ew pro g ram pur s uant to Section 3(g) of the Federal In se cticide, Fungicide, and R odenticide Act (FIFRA) , and will review each registered pesticide every 15 yea rs to determine whether i t continue s to meet the FIFRA standard for registration. Changes in scie nce , public policy , and pesticide us e practices occur over time. The re g i st ration revi ew program is intended to make sure that, as the ability to assess risk evolves and a s polici es and practices change , all register ed pesticide s continue to meet the statutory standard. The public pha se of registration review begin s when the initi al docket i s opened for each case. Informati o n o n this program is provi de d on the Agency's webs it e. 1 The FWP begins with any updates since the PWP was i ssued. Next i s a s umm ary of substantive comme nt s r ece i ved during the public comm ent period for the PWP conce rnin g anticipated data n eeds, expec t ed ri sk assess ments , or the est im ated tim e lin e id ent ifi e d in the P WP, and a sum mar y of the Agency 's responses to those comments. Thi s sec ti on is foll owed by re gis trati on review planned data needs, risk assessments expected to be conducted, an d the projected registration r ev i ew t imeline for MCPB. Lastl y, there is a discussion of n ext steps. UPDATES SINCE THE PWP WAS ISSUED The PWP listed the pollinator acute oral toxici ty and pollinator larval acute toxicity studies as anticipated da ta needs. Due to the Agency ' s new gu id ance for assess ing r isks to bees (see

guidance document dated June 19,2014 at http ://www2.e pa.g ov/s it cs/p roducti o n / fi les /2 014- 06 /docume nt s/pollinato r r i sk assessment guidanc e 0 6 19 14 .pd0, the Agency is modifying its pollina to r data requirements for MCPB to include two additional s tudi es: • C hronic oral toxicity to larval h o neyb ees • C hr on ic oral toxicity t o adult honeybees Various phenoxy herb ici des are known to contain dioxin/furan impurities as a result of manufacturing processes. Pre vio usly submitted dioxin/furan data for MCPB did not indicate levels of concern. H oweve r , modern analytical methods are able to d etect previously und etected levels of dioxin/furan i mpuriti es. This has prompted the Age ncy to m odi . fy its li st of data requirements to i nclude guide line 830.1700--p re limin ary ana l ysis in order to confirm the presence / l eve l of dioxin/furan impurities in MCPB product s u si n g the mo s t up-to-date analytical m ethods. The Age nc y notes that a study alr e ady e x i sts which may se r ve to fulfill this requir e m e nt (Sc hois s wohl , 201 1). 1 http ://w ww .e pa .go v / oppsrrd 1 / registration _rev iew / 2The Agency is also removing the requirement for guideline 860.1500 crop field trials on pea because a previously submitted study, MRID 44754101, fulfills this requirement.
SUMMARY OF COMMENTS AND AGENCY RESPONSES During the 60-day public comment period on the MCPB Preliminary Work Plan, which opened on March 28,2014 and closed on May 27,20 14, the Agency received 3 submissions from the public. Comments were submitted by The MCPB Task Force, the FIFRA Endangered Species Task Force (FESTF), and the Center for Biological Diversity. The MCPB Task Force provided technical corrections for information cited in the Agency's registration review documents and addressed the Agency's information request for additional data on dioxins and furans

. The FIFRA Endangered Species Task Force commented that the technical registrants, Nufarm Limited and Nufarm Americas, Inc., are members ofFESTF and are entitled to rely on FESTF data for endangered species risk assessment. The Center for Biological Diversity's comment addressed the Agency's responsibilities under the Endangered Species Act (ESA). The comments do not address the timeline described in the PWP, but they do address the planned ecological and human health risk assessments and data requirements. In the PWP, EPA also solicited comments on the specific topics ofenvironmentaljustice, water quality concerns, and trade irritants, but no comments or information were received on those issues. This section does not capture every comment made in response to the PWP nor all ofthe Agency's responses. Rather, the Agency has summarized those public comments that resulted in changes to the anticipated registration review data needs, risk assessments, or timeline, or are of a broader regulatory nature. Public comments and EPA responses in their entirety are located in the docket, EPA-HQ-OPP-2014-0 181 accessible at www.regulations.gov. Full public comments and Agency responses related to the anticipated ecological risk assessment or data needs are in the EPA Response to Comments Relatedto the Preliminary Problem Formulation.for Ecological Riskand Environmental Fate, EndangeredSpecies, andDrinking WaterAssessments for MCPB andIts Salt, while those relevant to the anticipated human health risk assessment or data needs are in the MCPB. Response to Comments ReceivedRegarding Scoping Document in Support of Registration Review. Comments submitted by the MCPB Task Force in EPA-HQ-OPP-2014-0181-0012. I. Comment: The Agenc y requesteddata on dioxinlfuran impurities in MC PBproducts in its registration reviewproblem formulation. The Task Force notedthat the Agency should identifYthe needfor such data in the data call-in. Response: Various phenoxy herbicides are known to conta in dioxinlfuran impurities as a result ofmanufacturing processes. Previously submitted dioxin/furan data for MCPB did not indicate levels of concern. However, modem analytical methods are able to detect previously undetected levels ofdioxin/furan impurities. This has prompted the Agency to modify its list ofdata requirements to include guideline 830.1700--preliminary analysis, in order to confirm the presence /level ofdioxinlfuran impurities in MCPB products using the

3most up-to-date analytical metho ds. The Agency notes that a study already exists which may serve to fulfill this requirement (S choisswohl, 2011) and should be submitted formally to the Agency. 2. Comment: The MCPB Task Force believes that the reque s t for additional pea field trial data has been made without consideration ofMRID 44 7 54101 , which was submitted in 1999 by interregional Research Project No. 4 (J R4 ). This study provides MCPB and metabolite residue datafrom eight residue trials conducted in typical pea producing areas of the US. The Task Force believes that thes e data are sufficient to suppo rt the continued registration of MCP B on peas. Response: During reg i st ration rev i ew, th e Agency will pe r f orm a fu ll eva l uation of MRID 4 4 7 54 I 0 1 for scient ific acceptability. A preliminary scree n of the data indicates th at the study i s sc i e nt ifica ll y accep table and appea r s to meet guideline 860.1500 r ecommen dati ons.

The Agency believes that MRID 44754 101 is adequate to fill the pea field trial data gap. Therefore , the Agency is r emovi n g the req uir ement for guideline 860.1500 crop field trials on pea. Comme nt s s ubmitted b y the Center for Biolo g ical Diversity in EPA- HQ-OPP-2014-0181- 0 011 . 3. Comment: The Centerfor Biolog ical Diversity ' s (CBD) c o mm e nts focus on the EPA ' s duty to consult with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) on the registration review of MCP B in accordance with the Endange red Species Act (ESA). The CBD comments mention various aspects of the risk assessment process , including use of the best available data to develop enda n ge red species risk assessments, and evaluation of effects on endangered and threatened species and their

designated critical habitat. CBD also expresses concern regarding the rigor of the Agency's preliminary determinations regarding the effects of MCP B on endangered and threatened (listed) species and their designated critical habitat for th e MCPB registration review. R espo n se: EPA has reviewed the co mments from CBD on the registrat i on review docket opening for MCPB and plans to address many of the concerns rai sed by CBD as part of the implementation plan for assessing the risks of pesticides to listed species based on the recommendations of the April 2013 National Academy of Sciences (NAS) report. EPA will add r ess concerns spec ific to MCPB in connection with the development of its fina l regi stration review decision for this pesticide. In November 2013, the EPA, along with the Services and the US D A, released a summary of their j oint Interim Approaches for assessing risks to endangered and threatened (listed) species from pesticides. The In terim Approaches were d eveloped joint l y by the agencies in response to the NAS recommendations and reflect a common approach to risk assessment shared by the agencies as a way of addressing scientific differences between the EPA and the Services. The N AS report outlines recommendations on specific scie n tific and techn ica l is s ues related to the developme n t of pesticide risk assessments that EPA and the Serv i ces must conduct i n connect ion with t heir o bli gations under the ESA and FIFRA. 4Thejoint Interim Approaches were released prior to a stakeholder workshop held on November 15, 2013. I n addition, the EPA presented thejointInterim Approaches at the December 2013 Pesticide Program Dialogue Committee (PPDC) and St ate-FIFRA Issues Research and Evaluation Group (SFIREG) meetings. The agencies also held a stakeholder workshop in April 2014, allowing additional opportunities for stakeholders to comment on the Interim Approaches. Additional workshops are planned to enhance stakeholder involvement; the next workshop is scheduled for October 2014. As part ofa phased, iteratjve process for developing the Interim Approaches, the agencies will also consider public comments on the Interim Approaches in connection with the development ofupcoming registration review decisions. The details ofthejointInterim Approaches are contained in the white paper, interim Approaches for National-Level Pesticide EndangeredSpeciesAct Assessments Based on the Recommendations of the NationalAcademy of SciencesApril 2013 Report, dated November 1, 20 13

. Giventhat the agencies are continuing to develop and work toward implementation ofthe Interim Approaches to assess the potential risks ofpesticides to listed species and their designated critical habitat, the ecological problem formulation supporting this Final Work Plan for MCPB does not describe the specific ESA analysis, including effects determinations for specific listed species or designated critical habitat , to be conducted during registration review. In the ecological problem formulation document for MCPB, EPA described the screening-level risk assessment to determine the potential effects ofMCPB on all taxa of non-target wildlife and plants, which will assume that listed species and their designated critical habitats may be present in the vicinity ofthe application ofMCPB. This screeninglevel assessment will allow EPA to focus its future evaluations on the types ofspecies where the potential for effects exists once the scientific methods being developed by the agencies have been fully vetted

. While the agencies continue to develop a common method for ESA a

nalysis, the planned screening-level risk assessment for the registration review ofMCPB will describe the level ofESA analysis completed for this particular registration review case. Once the agencies have fully developed and implemented the scientific methods necessary to complete risk assessments for endangered and threatened (listed) species and their designated critical habitats, .these methods will be applied to subsequent analyses for MCPB as part of completing this registration review.

5PLANNED DATA NEEDS Table 1 summarizes the planned data n eeds for MCPB based on the Re gistra tion Re view; Preliminary Probl em Fo rmulation for Environmental Fate , Ecological Risk, Endangered Species , and Human Health Drinking Water Expo sure Assessments for MCPB, MCPB and Salts . Human H eal th Assessment Scoping Document in Support of Registration Review , and MCPB. Respon se to Co mment s Received Regarding Scoping Document in Support of Registration R eview. The table has been updated since the PWP to reflect cha nges to the data needs. Tab l e 1 : P l a nne d D a ta N eeds for t h e MCP B Reg i stration Rev i ew Es tim ated T i me f rame Gu i deline S tud y Ti tl e Test (Mo n t h s from Number 2 Material rece i pt of DCI) Plan n ed Data Needs for MCPB 830.1700 Preliminary ana l ysis M P 8 835 .241 0 Photodegradatio n on soil TGAI 12 8 35.4400 Anaerobic aquatic m etabo l i sm TGAI 24 850.1 300 Aquat i c invertebrate life cycle (freshwater) T GAI 12 850.1 350 Aquatic invertebrate life cycle (sa l twater) TGAI 12 850.1400 Fish early-life stage (estuarine / m a r ine) T GA I 12 850.2100 Avian oral toxicity (passerine ) 2 T GA I 12 850.2300 Avian reproduction (mallard duck) 3 TGAI 24 850.4400 Aquatic plant growth (aquatic vascu l ar plant toxicity) TE P 1 2 850.4500 Algal toxicity TE P 12 870.3465 28-day i n ha l atio n -ra t TGAI 24 875.2100 Dislodgea bl e folia r res id ue TE P 24 No n - Po ll i n ato r ac ut e o r a l toxicity --h o n eybee adul t 3 T EP 12 g u ide lin e Non- Po ll inator acute ora l t ox i city

-- honeybee l arvae 3 • 4 TGAI 12 gu i de l ine

· Non- Po ll inator chronic oral toxicity-honeybee larvae 3 • 4 TGAI 12 guideline Non- Pollinato r chronic oral toxicity-honeybee adult 3 TGAI 12 gu idelin e 2 On June 27 , 2012 , EPA announced certain revisions in harmoni zed guide lin e series 850 - Ecological Eff ects Tests - includin g renumbering and other designations or changes for so me gu ideline studies. See " Final Test Guidelines; OCSPP 850 Series; Notice of Availability " 77 FR 38282, June 27, 20 12 . h ttp :// www .rcgu I a t io n s.gov /# ! docu mentD e t a i l; D = E P A -H Q - QPPT-2009-0 1 54-0028 3 The planned D C I will note that in lieu of data on MCPB, the Agency will accept data on MCPA for this data need. 4 A r epeat do se honeybee larval toxicity study with both acute and chronic toxicity endpoints may be subm i tted to satisfy this requirement. 6Table 1: Planned Data Needs for the MCPB Registration Review Estimated Guideline Timeframe Number Study Title Test (Months from Material receipt of DCI) Outstanding Data Requirements from

**GDCI-019201-26570**

**~** 835.6100 Terr estrial field dissipation6 TEP In review 850.1075 Freshwater fish toxicity (sheepshead minnow) TGAI/TEP In review 850.1400 Fish early-life stage (freshwater) TGAI In review 860.1850 Confined rotational crop7 TEP In review TGAI = techmcal grade active mgred1ent; TEP = typical end-use product;


### RISK ASSESSMENTS FOR REGISTRATION REVIEW During

**r~gistration** review, the Agency will conduct a comprehensive ecologica l risk assessment, including an endangered species assessment, for all uses ofMCPB. For human health, EPA will conduct revised dietary, residential, and occupational risk assessments during registration review. Iftoxicological endpoints orpoints ofdeparture are revised based on the data that are required for registration review, they will be considered in the new assessments, as well as any changes to the standard operating procedures or default exposure assumptions. Table 2 summarizes the planned registration review risk assessments based on the EFED Problem Formulation and HED Scoping Document; the planned assessments have not changed from what was included in the PWP.

5 The studies listed in this section were previously required through a generic data call-in issued in March 2007.

These studies will not be included in the anticipated Registration Review DC! because they are already required through the earlier DCI and have been previously submined and are undergoing review for acceptability

. 6 Data on the storage stability component ofthis study is still outstanding. Independent laboratory validations are

required for the previously submined environmental chemistry methods in soil and water. 7 Data for MCPA were submined in lieu ofdata for MCPB and will be reviewed by the Agency. 7Table 2: Planned Risk Assessments for the MCPB Registration Review Typ e of Risk Assessment Conduct? Notes Ecological and Environmental Fate Comprehensive eco l ogical y (species to be assessed include terrestria l and aquatic organisms), including endangered species

Ecologica l incidents Will check for There was one reported terrestr i al p l ant incid en t for updates MCPB. For a discussion of reported ecolog i cal incidents for MCPB, see the Problem Formulation. Human Health D i eta r y Food y An updated drinking water assessment is likely , Drinkin g water y therefore, a revised dietary assessment i s planned. R e sid e n t i a l Handlers N There are no registered res i dential uses ofMCPB, Post-application N ther efore a qua n titative exposure/risk assessment for direct residential exposure is not necessary. Bystander y Residential exposures re s ulting from off-s ite transport may occur as a result of agricultural applications of MCPB. During registration rev i ew, the Agency will eva l uate the need to assess potential r esidential b y sta n der ex po s ure . O c cup a ti o n a l Handlers (mixers, loaders, y An updat e d occupational assessment is planned to app li cators) incorporate occupational exposure data be i ng required Post-a pp licat ion y ( i . e . , dislodgeable folia r r esidue data). Oth er Aggregate y Evaluates the combined risk from dietar y and residential exposures. An updat e d aggregated assessment may be warranted to reflect any updates to the dietar y and / or residential assessments. Cumulative N MCPB is a member of the alky l phenoxy herb i cide class of pes t icides. Although the phenoxy herbic i des have sim il ar structural componen ts , t he Agency has no t made a determ i nation tha t th ey have a common mode of toxic action, and therefo r e a cumulative risk assessment is not planned for MCPB. T olerances y The Agency plans to revise the to l erance expressions fo r MCPB during registration review to be comp li ant with current policie s . 8Human health incidents Will check for For a discussion ofreported human incidents for updates MCPB, see the Scoping Document and the MCPB [4- (2-meth yl-4-chloro phenoxy ) butyric acid] andSalts: Tier I Review of HumanIncidents. There were no incidents reported for MCPB.

TIMELINE EPA has created the following estimated timeline for the completion ofthe MCPB registration review in Table 3 below. The projected timeline has not changed since the PWP

. Table 3: Registration Review for MCPB- Projected Registration Review Timeline Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period March 2014-completed Close Public Comment May 2014-completed Case Development Final Work Plan September 20 14-completed Issue DCI 2014 Oct.

- Dec. Data Submission 2016 Oct.

- Dec. 60-day Public Comment Period for Draft Risk 2018 April

- June Assessments Registration Review Decision 60

-day Public Comment Period for Proposed 2019 Ja n. - March Registration Review Decision Registration Review Decision and Begin Post

-Decision 2020 Follow-up Total (years) 6

NEXT STEPS As noted previously, the Agency plans to require several environmental fate, ecological effects, a

nd human health studies for MCPB through a Data Call-In Notice, expected to be issued in late 2014.

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