### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

MEMORANDUM DATE: March 27,20 13 

### OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

SUBJECT: Folpet: HED 's Response to Comments on the Folpet Preliminary Work Plan (PWP) 

### PC Code: 08160 I 

### Decision No.: 475795 

### Petition No.: N/A Risk Assessment Type: N/ A 

### TXRNo .: N/A MRID No.: N/ A 

### DP Barcode: 409609 

### Registration No.: N /A Regulatory Action: Registration Review 

### Case No.: 0630 

### CAS No.: 133-07-3 

### 40 CFR: N/A Jessica Kidwell , Risk Assessor

# ~**~** RAB I V , Health Effects Di vision

### (7**~9P )**  

### FROM:
THROUGH: Elis sa Reaves, Ph.D. , Branch Chief

# ~**__......-'** RAB I V, Health Effects Division (7509P) 

### TO: Christina Scheltema, RM53 Tracy Perry , Team Leader Patricia Parrott, Branch Chief RMIB3 , PRD (7508P)
Please find attached the Health Effects Di vision's ( HED's) response to public comments received on the preliminary work plan for registration review of folpet (Docket EPA-HQ -OPP

20 12-0859). The HED has responded to those issues speci fically relev ant to the purview of HED on a point-by -po int basis.

Page 1 of7A
. Comments from Makhteshim Agan of North America (MANA ) , Robert Everich ( Case Number 0630): 1) Anticipated Data Needs:

870.3465 90

- day Inhalation TGAI MANA will address the data gap 

## if this is requested in the Data Call-In 870
. 7800 lmmunotoxicity TGAI MANA will address the data gap 

## if this is requested in the Data Call-In 875.1200 Dermal Exposure, Indoor TEP MANA will address the data gap 

## if this is requested in the Data Call

-In 875.1400 Inhalation Exposure, Indoorl EP MANA will add ress the data gap 

## if this is requested in the Data Call-In HED Response: EPA thanks MANA for addressing the data gaps listed above s ince HED has identified t hese stud ies as requ ired in the seeping document and should be requested in the Data Ca ll -In. T he Agency also notes that 870
. 2300 Indoor Surface Residues was also listed in HED 's Seeping D ocument as a data gap and should also be requested in the Data Call -In. 2) Use and Usage Information MANA Comment: EPA believes label amendments are needed to clarify the directions for use for one product, FOLPAN 80 WDG (EPA Reg i stration Number 66222

-48): (1) revise the maximum rate of ap plication on hops to be 2 lb 

### ail A/application; (2) revise the PHI for avocados to 7 days; (3) at the application rate currently on the FOLPAN 80 WDG label, add a 48 hour reentry interval (REI) to reach an acceptab le MOE for training hops vines . T he Agency will work with the reg i strant to amend this label prior to the reg i stration review assessment for folpet. MANA will cooperate w ith EPA on these label amendments. HED Response : HED appreciates MANA's cooperation with these label amendments. To be clear, w ith regards to FOLPAN 80WDG (EPA Regis tration Number 66222-48) labe l amendments for use on hops, HED is recommending a reduction of the cur rently reg i stered maximum use rate on hops from 2.4 lb ai/ A/app li cat ion (3 lb product/ A/app li cation) to 2 lb ail A/application (2.5 lb product/A/appli cat ion ) to be consistent with the maximum use rate demonstrated in the availab le hops U
. S. field trial data for folpet which are the basis for the currently established U.S
.**~olerance** for folpe t inion hop, dried cones (120 ppm). If the maximum use rate i s reduced as recommended, then a 24 hour REI will be accep tab le. Page 2 o f 7

### 3) Trade irritants: Lack of MRL MANA 

### Comment: The tab le detailing international Residue Limits on page 31 of EPA's human health risk seeping document (EPA-HQ-OPP-2012

- 0859-002) is accurate except for the following Codex limits which are missing: Bulb Vegetables
. . . 1 ppm Current
. . . . . . . . . . . . . 40 ppm Potatoes ------------0
. 1 ppm MANA is also aware of differences between EU and US MRL's. However we are not aware of any potential trade irritancy issues that cou ld arise because of that discrepancy. Folpet is registered and used in Mex ico and several other Central American and South American countries who export their commodities to the US. It is therefore important to maintain the existing import MRL's and avoid potential trade irritants. 

### HED Response: HED appreciates MANAs comment. The International Residue Limits table of the document entitled , " Folpet: Human Health Risk Seeping Document in Support of Registration Review" (EPA-HQ

- OPP-2012-0859

-002) does include Codex MRLs for currants at 40 mg/kg (see Codex listing under dried grapes (currants, raisins, and sultanas)) and potato at 0.1 mg/kg. HED finds no currently establis hed Codex MRL for the entire bu lb vegetab le crop group; however, the currently established Codex MRL for bulb onion at 1 mg/kg is listed in the subject table/document. 

### 4) Environmental Justice

MANA 

### Comment: MANA is not aware of any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical , unusually high exposure to folpet compared to the general population. 

### HED Response: HED appreciates the comment. 

### 5) Endocrine Disrupter Screen ing Program

MANA Comment: Folpet EDSP studies: All but one have been submitted and are in review at the Agency. The EPA ' s latest update http: //www.epa.gov/endo/ pubs/ed s p orders status .pdf dated January 3, 20 13 is accurate. 

### HED Response: HED appreciates the comment. This status update is correct.

Page 3 of76) Human studies MANA Comment: MANA is not aware of any folpet studies for which the conduct was either fundamentally unethical or significantly deficient relative to the ethical standards prevailing at the time the research was conducted. HED Response : HED appreciates the comment.
B. Comment Submitted by Ann E. George, U.S. Hop Industry Plant Protection Committee (EPA-HQ-OPP-2012-0859-0009) Thi s submission includes supplemental comments to those submitted to this docket previously. The Agency i s proposing a reduction in the application rate on hops to 2 lbs/ai/ A/application
. Thi s will reduce the application rate of product from the current 3lbs of 80WDG to 2
.5 lbs per app lication. Also, the Agency is asking for a 48hr REI for training hop vines. These changes are acceptable to the US hop industry. Thank you for the opportunity to submit these additional comments.
HED Response: HED appreciates the comment. To be clear, with regards to FOLPAN 80WDG (EPA Registration Number 66222

-48) label amendments for use on hops, HED i s recommending a reduction of the currently registered maximum use rate on hop s from 2.4 lb ai/ A/application (3 lb product/ A/application) to 2 lb ail A/application (2.5 lb product/ A/app li cation) to be consistent with the maximum use rate demonstrated in the available hops U.S
. field trial data for folpet which are the basis fo r currently established U.S. tolerance for folpet inion hop, dried cones (120 ppm)
. If the maximum use rate is reduced as recommended, then a 24 hour REI will be acceptable.

Page 4 of7C. Comment Submitted by Ann E
. George, U
. S. Hop Industry Plant Protection Committee (EPA-HQ-OPP-2012-0859-0008)

The US hop indu stry strongly supports the continued registration offolpet for hops, and maintenance of the MRL for this active ingredient. This product is important for domestic usage, as an alternative class ofchemistry for resistance management. In add ition , it i s critically important to maintain the US MRL for folpet on hops (120 ppm), as it is harmonized with both the European Union (150 ppm) and Japan (120 ppm), two major US hop trading partners. The loss of this MRL would prove detrimental to European hop growers who ship their crop to the US. Loss of the US MRL would create a trade irritant with European hop producing countries. We need to maintain the use offolpet for U.S. growers and the tolerance for U.S
. imports of treated hops from Europe. HED Response: HED takes note of and appreciates the comment. D. Three Similar Comments dated February 6, 2013 from Entomology Managers (lng. Jesus Vidal, Del Campo Y Asociados sa de CV
. ; Ing
. Vicente Rodriguez Zamudio, International Greenhouse Produce sa de CV; Ing. Angel Blanco Carrillo, Valores Horticolas del Pacifico sa de CV.) In the Folpet Preliminary Work Plan, it is noted that folpet has import tolerances that were established fo r apple, cranberry, cucumber, grape, raisin, lettuce, melon, onion (dry bulb), strawberry (KeigwinJr. and McLain 2012) and tomato. These were established since there were no US registrations for the use of folpet on these commodities but folpet was used on produce that was imported to the United States. We wish to comment on the continued need to maintain these import to lerance
. Within the protective fungicides, folpet is one the few remaining alternatives for handling various important dis eases in our region. Revoking import tolerance s would result in our inability to produce high quality farm products for export purposes . [At our farm, located at Culiacan, Sinaloa, we grow Vegetables: 238 hectares of tomato and cucumber and export some of this produce to the United States. The maintenance of import tolerances is in the interest of both the United S tates and farmers that export produce to the United States.] from comment from Ing. Jesus Vidal, Del Campo Y Asociados sa de CV (At our farm, located at Culiacan, Sinaloa, we gro w Vegetables: 238 hectares of tomato and cucumber and export some of this produce to the United States. The maintenance of import tolerance s is in the interest of both the United States and farmers that export produce to the United States.]from comment from Ing. 

### Vicente Rodriguez Zamudio, International Greenhouse Produce sa de CV Page 5 of7[At our farm, located at Culiacan, Sinaloa, we grow Vegetables: 520 hectares of tomato and cucumb er and export some of this produce to the United States. The maintenance of import tolerances is in the intere st of both the United States and farmers that export produce to the United States.] 

### from comment from lng
. Angel Blanco Carrillo, Valores Horticolas del Pacifico sa de CV.) We also understand that folpet has been reevaluated for cancer risk to humans and is no longer classified as "B2" (probable human carcino gen). Since the acute toxicity of folpet is quite low and is acknowledged as not having a cancer risk due to expected residues. HED Response: Thank you for your comment on the continued need to maintain the import tolerances for folpet. E
. Comment from Alvaro Velasquez Quintero, Finca el Remanso, Vereda el Aguacate , Belen de Umbria, Risaralda, Colombia, Cultivo sembrado: Aguacate Por medic de la presente me permito comentarles que dentro mi cultivo de Aguacate variedad Papelillo ubicado en el municipio de Belen de Umbria, Risaralda, Colombia uso con periodicidad el ingrediente activo folpet para el control de algunas enfermedades limitantes como la Antracnosis. Es por esto, que solicito por favor mantener las tolerancias de importaci6n de este activo ya que es de vital importancia en mis programas de rotacion debido a que controla eficazmente la Antracnosis. Agradezco su atencion y compression. 

### Translation : "within my avocado crop variety papelillo located in the town of Belen de Umbria Columbia, us e with the active ingredient folpet frequency control limiting diseases such as anthracnose. This is why I request, please keep import tolerances of this asset as it is vital in my rotation programs as it effectively controls Anthracnose." HED Response: Thank you for your comment on the continued need to maintain the import tolerances for folpet.
F. Comment from Ashland, Inc. , JaneS
. Vergnes , Senior Manager, Product Regulatory, Case #0630, February 12, 2013. International Specialty Products (ISP), a wholly owned subsidiary of Ashland Inc. (Ashland), submits the following comments in response to the December 14, 2012 Federal Regi ster Notice stating that the Agency had established the subject registration review docket for folpet Page 6 of7and is providing a 60 day comment period on the preliminary work plan (EPA-HQ-OPP-2012- 0859 -0 006). ISP, through Ashland Inc's bus iness u nit Ashland Specialty Ingredients, offers industry-leading products, technologies and resources for solving formulation and product performance challenges in key markets including personal care, pharmaceutical, food and beverage, coat ings and energy. Using natural, synthetic and semi-synthetic polymers derived from plant and seed extract, cellulose ethers and vinyl pyrrolidones, Ashl and Specialty Ingredients offers comprehens ive and innovative solutions for today's demanding consumer and industrial applications. Ashland's folpet based material preservatives offer industrial users broad spectrum, UV s table antimicrobial preservatives for non-aqueous paints, coatings, stains, caulks and p lastics. Anticipated Data Needsj Ashland concurs with the comments submitted by Makhteshim Agan ofNorth America (MANA) regarding anticipated tec hnical data needs for the folpet registration review. HED Response: Thank you for your comment regarding anticipated data needs.

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