UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

DATE: March 27,2013 

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 

FROM: Jessica 

RAB IV

Kidwell

, Health 

, 

Effects 

Risk Assessor 

Division (7

~ ~9P) ~ 

THROUGH: Elissa Reaves, Ph.D., Branch Chief ~ __......-' RAB IV, 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 Division's (HED's) response to public comments 

received on the preliminary work plan for registration review of folpet (Docket EPA-HQ-OPP20 12-0859). The HED has responded to those issues specifically relevant to the purview of HED 

on a point-by-point basis. 

Page 1 of7 
A. 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 address the data gap if this is requested in the Data Call-In 

HED Response: EPA thanks MANA for addressing the data gaps listed above since HED has 

identified these studies as required in the seeping document and should be requested in the Data 

Call-In. The Agency also notes that 870.2300 Indoor Surface Residues was also listed in 

HED's Seeping Document 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 Registration Number 66222-48): (1) revise the 

maximum rate of application 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 acceptable MOE for training hops vines. The Agency will 

work with the registrant to amend this label prior to the registration review assessment for folpet. 

MANA will cooperate with EPA on these label amendments. 

HED Response: HED appreciates MANA's cooperation with these label amendments. To be 

clear, with regards to FOLP AN 80WDG (EPA Registration Number 66222-48) label 

amendments for use on hops, HED is recommending a reduction of the currently registered 

maximum use rate on hops from 2.4 lb ai/ A/application (3 lb product/ A/application) to 2 lb 

ail A/application (2.5 lb product/A/application) to be consistent with the maximum use rate 

demonstrated in the available hops U.S. field trial data for folpet which are the basis for the 

currently established U.S. ~olerance 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 2 of 7 
3) Trade irritants: Lack of MRL 

MANA Comment: The table 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 could arise because of that discrepancy. 

Folpet is registered and used in Mexico 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 established Codex MRL for the entire bulb vegetable 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 Screening 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/edsp orders status.pdf 

dated January 3, 

20 13 is accurate. 

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

Page 3 of7 
6) 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) 

This submission includes supplemental comments to those submitted to this docket previously. 

The Agency is proposing a reduction in the application rate on hops to 2lbs/ai/ A/application. 

This will reduce the application rate of product from the current 3lbs of 80WDG to 2.5 lbs per 

application. 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 is 

recommending a reduction of the currently registered maximum use rate on hops from 2.4 lb 

ai/ A/application (3 lb product/ A/application) to 2 lb ail A/application (2.5 lb 

product/ A/application) to be consistent with the maximum use rate demonstrated in the available 

hops U.S. field trial data for folpet which are the basis for 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 of7 
C. Comment Submitted by Ann E. George, U.S. Hop Industry Plant Protection 

Committee (EPA-HQ-OPP-2012-0859-0008) 

The US hop industry 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 of chemistry for resistance management. 

In addition, it is 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; In g. 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 for 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 tolerance. 

Within the protective fungicides, folpet is one the few remaining alternatives for 

handling various important diseases in our region. Revoking import tolerances 

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 States 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 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 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 cucumber and export some of this produce to the United States. The 

maintenance of import tolerances is in the interest 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 carcinogen). 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, use 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 Register 

Notice stating that the Agency had established the subject registration review docket for folpet 

Page 6 of7 
and is providing a 60 day comment period on the preliminary work plan (EPA-HQ-OPP-2012-

0859-0006). 

ISP, through Ashland Inc's business unit 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, coatings 

and energy. Using natural, synthetic and semi-synthetic polymers derived from plant and seed 

extract, cellulose ethers and vinyl pyrrolidones, Ashland Specialty Ingredients offers 

comprehensive and innovative solutions for today's demanding consumer and industrial 

applications. Ashland's folpet based material preservatives offer industrial users broad 

spectrum, UV stable antimicrobial preservatives for non-aqueous paints, coatings, stains, caulks 

and plastics. 

Anticipated Data Needsj 

Ashland concurs with the comments submitted by Makhteshim Agan ofNorth America (MANA) 

regarding anticipated technical data needs for the folpet registration review. 

HED Response: Thank you for your comment regarding anticipated data needs. 

Page 7 of7