UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D

.C

. 20460



### MAR
- 2 2016 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

MEMORANDUM

SUBJECT: FROM:

THRU:

TO: Paraquat: Potential Impacts ofProposed Mitigation Measurjr 

# d
Jonathan Becker, Ph.D. , Senior Science Advisor 

# ./!/**~** Bill Chism, Ph.D. , Senior Biologist**b......,,l~~:.·~~r --**  Sunil Ratnayake, Ph.D. , Biologist**~ ~**  Biological Analysis Branch 

# l
Derek Berwald, Ph.D., Economist (I

__

# ~**l,(J\ ~**  Economic Analysis Branch**~** Biological and Economic Analysis Division 7503P) Colwell Cook, Ph.D. , Acting Chief

# d4fvBiological Analysis Branch Timothy Kiely, Chief

# ~ , ,, I\

# \~ Economic Analysis Branch 

### VV \, Biological and Economic Analys Division (7503 ) Marianne Mannix, Chemical Review Manager Tracy Perry, Team Leader Kelly Sherman, Chief Risk Management and Implementation Branch 3 Pesticide Re-evaluation Division (7508P)

Product Review Panel date: February 24, 2016

Page 1 of9

### SUMMARY The EPA is proposing mitigation measures to minimize human health incidents associated with paraquat. Based on available data, BEAD estimates that the implementation ofthe proposed mitigation for paraquat will have the following impacts: Label amendments

- no grower impact; closed systems

- costs ranging from $500 to $700 per user that needs to upgrade their system, for a total of$12.5 million to $17

.5 million in one-time costs across all paraquat users ; prohibition of hand-held application equipment

- not estimated due to lack ofdata; restriction ofuse to certified applicators only

- additional cost would be about $1.3 million annually across all paraquat users ; development ofparaquat-specific applicator training material

- costs from $3, 100 to $4,700 per registrant. Important uncertainties associated with these estimates are described in the text. 

### BACKGROUND Paraquat dichloride, a restricted use pesticide, is used as an agricultural herbicide and desiccant. This chemical is highly toxic to mammals through all routes ofexposure and there is no known antidote for exposure to this chemical. Paraquat has been used as a suicide agent and there have been a large number ofdeaths resulting from the accidental ingestion ofparaquat when compared to similar pesticides. The accidental ingestion incidents often result from paraquat being stored in beverage containers, contrary to clear label language prohibiting transfer into other containers

. Paraquat is also corrosive to skin and is associated with a number ofworker incidents involving exposure from equipment leakage or accidental contact with sprays in occupational settings. There have been multiple regulatory measures since the late 1980s to reduce the occurrence of accidental and intentional ingestion, including labeling and the incorporation ofdyes, stenching agents, emetics, and gelling agents in the formulation. The 1997 Reregistration Eligibility Decision (RED) also required changes to lessen the occupational and ecological risks. In 2011 , EPA initiated the Registration Review process for paraquat, which noted a moderately high frequency ofhuman health incidents. In 2013 , the EPA received letters from the public noting that fatalities due to accidental ingestion were still occurring and calling on EPA to take action

. The EPA responded to these letters and initiated an analysis ofparaquat incidents. Based on the results ofthis analysis, the EPA is proposing additional mitigation measures to minimize human health incidents associated with paraquat. These measures are: (1) label changes emphasizing the toxicity ofparaquat, (2) use ofa closed-system (similar to the lock-andload system) for transferring paraquat out ofall product containers, (3) prohibition of applications using hand-held equipment, (4) restricting the use ofparaquat to certified applicators only (i.e., prohibiting application by individuals working under the supervision ofa certified applicator), and (5) requiring the development ofparaquat-specific applicator training material. This document considers the potential impact ofthe proposed mitigation measures based on currently available information. Page 2 of9POTENTIAL IMPACTS OF PROPOSED MITIGATION

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LabelAmendment s Mitigation measure : Paraquat labels will be amended to highlight ingestion risk, clarify toxicity, and add supplemental warning materials. Potential impacts: Because these label amendments highlight ingestion risk, toxicity, and add warning materials, BEAD does not anticipate impacts to the grower from these label amendments. Closed S ystems Mitigation measure: The EPA is proposing to require all containers to be engineered so that paraquat must only be removed from the container using closed system technology meeting the following criteria: 1) The closed system must connect to the container in a way that the closed system is the only feasible way to remove paraquat from the container without destroying the container, 2) screw caps that can be removed allowing paraquat to be poured from the container are prohibited, and 3) the closed system must remove the paraquat from its original container and transfer the paraquat to the application equipment through connecting hoses, pipes and couplings that are sufficiently tight to prevent exposure ofthe mixer or loader to the paraquat, except for the negligible escape associated with normal operation ofthe system
. The anticipated impacts of this mitigation measure on paraquat human health risk include the elimination ofthe opportunity for paraquat to be decanted into beverage (or any other inappropriate) containers and a reduction in spills and dermal exposure thus minimizing incidents resulting from improper use ofPPE and the unsafe handling ofparaquat. Potential impacts : Requiring closed systems would require users ofparaquat who do not have closed systems to purchase them, and users with closed systems may need to pay for upgrades to bring the system into compliance with paraquat standards. For information on the cost of adopting a closed system for farmers , EPA contacted an industry representative who manufactures and sells closed systems and closed system components
. The reported cost ofa system that corresponded to the mitigation requirements was $500 to $700 per unit (Industry Communication, 2015). There is also a small additional cost for closures on the pesticide container that cannot be removed and mate with the closed system
. As a baseline, EPA assumes that all growers and certified applicators will need to purchase a new system that meets the standards for the paraquat mitigation

. Many growers and commercial applicators, particularly large ones, may already have closed systems to minimize exposure to pesticides from mixing and loading activities. However, we cannot assume that these existing systems will be compatible with what is required for paraquat. Based on available usage data, about 25,000 farms apply paraquat annually

. Some ofthese farms may already have systems for handling pesticides that reduce the exposure to workers , handlers and applicators, but those systems may not be designed for and compatible with Page 3 of9closures for paraquat containers. Ifall ofthose growers need to pay for and install new equipment with a cost of$500 to $700, then the total, one-time cost to growers will be from $12.5 million to $17.5 million. There is a great deal ofuncertainty around this estimate. Some growers, particularly large ones may have systems that are compatible with a new closure system for paraquat, or would face lower costs for adapting an existing system. It is also possible that other paraquat users, faced with expensive, one-time upgrade costs will either switch to alternative chemicals, or hire commercial pesticide applicators for paraquat treatment. It is also possible that paraquat manufacturers may subsidize the cost ofnew closed systems. These estimates are limited by uncertainties in these actual costs ofclosed systems, the number ofapplicators who would need to buy such systems, knowing whether existing systems would be compatible with new standard closures, and any training costs associated with closed systems.

Prohibition of HandApplications Mitigation measure: The EPA is proposing to prohibit the use ofall hand-held application equipment, including backpack sprayers and hand gun sprayers, for paraquat. Potential impacts: Prohibition ofhand-held equipment may cause growers to change to alternative chemical, or mixtures ofchemicals to achieve similar weed control Paraquat is a rapidly acting, broad-spectrum, chemical used as an herbicide and as a desiccant, with relatively rapid-bum down efficacy. Survey and extension data suggest that hand-held applications ofparaquat are made for weed control and not as a crop desiccant. Paraquat's combination ofcharacteristics are not found in any other single alternative herbicide. The two herbicides with the most similar characteristics and use patterns to paraquat are glufosinate and glyphosate. Table l compares the characteristics ofthese three herbicides.

Page 4 of9T bl 1 Ch a e f l fi

. d l h aractenstlcs o paraquat, g u osmate, an g yp osate Characteristics Paraquat Glufosinate Glyphosate Weeds Selectivity Non selective Non selective Non selective Pre-plant Pre-plant Pre-plant Post directed Application No paraquat tolerant Post-emergence on Post-emergence on Liberty Link crops. Roundup Ready crops crops. Hand-held Permitted Permitted Permitted equipment Herbicide activity Contact Contact Systemic Coverage Complete coverage of Complete coverage of Complete coverage of foliage is needed foliage is needed foliage is not needed Activity Very rapid action Rapid action Slow action Rain-fastness 15 to 30 minutes 4 hours Varies by product (30 min to several hours) Crop rotational 0 days Crop dependent Crop dependent interval (0 to 180 days) (0 to 30 days) Approximate cost per acre $7.00 $11.00 $5.00 Based on extension publications, product label s, and Market Research Data ( 1998-2008)

. Depending on the particular combination ofcharacteristics the grower requires, either glufosinate or glyphosate may be selected with a concomitant change in per-acre costs. Other growers will select a combination ofactive ingredients to provide the desired combination ofcharacteristics. Currently it is not possible to quantify the impacts of switching to alternatives because oflimited information on the use sites where hand-held application equipment is commonly used. The large number ofherbicides that could be tank mixed to achieve similar characteristics also complicates the quantification. The use of small volumes ofparaquat may indicate that growers use hand-held equipment. Paraquat is sold in several sizes ofcontainers ranging size from one gallon to 2,000 gallons

. The one gallon containers are only sold in Puerto Rico. Discussions with weed scientists in Puerto Rico suggest that paraquat is commonly applied by hand

. Iftrue, then the prohibition ofhandheld equipment in this area may have a larger regional impact.

Restrict Use to CertifiedApplicators Mitigation measure: Paraquat dichloride is currently classified as a restricted use pesticide (RUP). As a RUP, paraquat can be used by certified applicators or those under their supervision. The EPA is proposing to restrict the use ofparaquat to only allow certified applicators who have met the applicatory competency standards established by states, tribal, and federal agencies to use or handle paraquat. Potential impacts: This mitigation measure would increase costs to growers to the extent that certified applicators have a higher opportunity cost oftime or charge more for application Page5of9services than those who currently apply paraquat under their supervision

. The additional cost of this requirement can be estimated by the difference in wages between certified applicators and those they supervise. As part ofthe proposed revisions to the standards for certified applicators, OPP has estimated wage rates and the number ofapplicators by state for certified applicators and those who apply RUPs under their direct supervision (EPA 2015a)

. Certified pesticide applicators can either be commercial, when they apply pesticides for hire, or private ifthey apply pesticides on their own farm or without pay. The estimated cost for an hour oftime is $52 for private certified applicators and $21 for commercial certified applicators. The difference in cost for these two is based on the cost oftime being higher for private applicators, who are farmers and business owners . For uncertified applicators under the supervision ofa certified applicator, the estimated wage rates are $18 for those supervised by commercial applicators, and $21 for those supervised by private applicators, (EPA 2015a, based on data from the Bureau ofLabor Statistics). Available pesticide use data indicate that an annual average of7.5 million acres were treated with paraquat as an herbicide from 2009

- 2014, and about 5 million ofthose acres were farmer applied; the remainder were applied by custom applicators or the applicator was not identified (Market Data Research, 2010-2014). In addition, paraquat is widely used as a desiccant on some crops, such as cotton and potato. The data available to EPA does not cover other desiccant uses, but for cotton and potato alone, about 1.9 million acres are treated with paraquat annually; about 1.4 million acres (74%) ofthose acres are treated by the farmer, with the rest (about 500,000 acres) treated by custom applicators (Market Data Research, 2010-2014). EPA does not have information on the acreage ofother crops treated with paraquat as a desiccant. Taken together, this information reflects about 6.4 million acres treated by farmers, and about 3 million acres treated by custom applicators, which we assume to be commercial applicators

. The difference in hourly cost is $31 for every hour ofapplication being made by a certified private applicator instead ofan applicator under their supervision, and $3 per hour for commercial applicators instead ofan applicator under their supervision. To estimate the amount ofapplication time that would need to be substituted, we begin with available pesticide usage data, which shows about 7.5 million acres treated with paraquat annually (Market Data Research, 2010-2014). There are a range ofestimates ofthe number ofacres that can be treated by a sprayer in an hour' s time. We use an estimate of 10 acres per hour (Iowa State University, 2002), which corresponds to a 20 foot sprayer, the lowest reported in that study. This is a low estimate ofthe number ofacres per hour that can be treated, which may correspond to a small sprayer in an orchard

. Larger sprayers on field crops can apply faster; for example, 28 acres per hour on field crops in Illinois (University ofIllinois, undated), 44 to 46 acres per hour in Minnesota (Lazarus, 2013), or 55 acres per hour in Iowa (Iowa State University, 2002). Using a low estimate ofacres treated per hour will inflate the estimated costs ofrequiring all applications to be made by a certified applicator. Ifa sprayer can treat 10 acres per hour (Iowa State University, 2002), then nationally that requires 640,00 hours ofapplicator time by private applicators, and 300,000 hours by commercial applicators. Ifan applicator can treat 10 acres per hour, then substituting a certified applicator for an uncertified applicator under their supervision costs $3 .10 per acre for private applicators and $0.30 for commercial applicators

. Page 6 of9To estimate the total cost ofrequiring application by certified applicators only, we need to estimate the number ofacres treated with paraquat by certified applicators compared to those under their supervision. The Economic Analysis for the proposed changes to the certification standards estimated that there were about 82,000 private certified applicators nationwide, and about 2,800 noncertified applicators under their supervision (EPA 2015a)

. There were about 414,000 certified commercial applicators, and 947 ,000 uncertified applicators under the supervision ofa certified applicators (EPA 2015a). Ifthe ratio ofnoncertified to certified applicators reflects the proportion ofparaquat acreage treated by noncertified applicators, then about 3

.3% ofthe 6.4 million acres treated annually by private applicators and about 70% ofthe 3 million acres treated by commercial applicators are treated by uncertified applicators under the supervision ofcertified applicators. That implies that about 211 ,000 additional acres would need to be treated by private applicators at an additional cost of$3 .10 per acre, and an additional 2.1 million acres would need to be treated by commercial applicators at an additional cost of$0.30 per acre. The total additional cost from requiring only certified applicators to apply paraquat is $1.3 million annually, almost -equally divided between private (about $650,000) and commercial (about $630,000) , as shown in Table 2.

Table 2. Estimated Cost of Restricting Application of Paraquat to Certified Applicators Only

. Wage Cost Additional per Acre, at Estimated Cost for Wage 10 Acres per Acres Treatment by Rates Hour Treated Applicator* Private Certified Applicator $52 $5

.20 6,190,000 $651,000 Private Uncertified Applicator $21 $2.10 210,000
Commercial Certified Applicator $21 $2.10 910,000 $627,000 Commercial Uncertified Applicator $18 $1.80 2,090,000 Total $1,278,000 *The additional cost is the difference in cost per acre for substituting certified applicators times the numbers of acres treated by uncertified applicators

. For private applicators, the difference in cost is $3

.10 per acre, and for commercial applicators $0.30 per acre
. Labor rates are from 2013

. Source : EPA Calculations, based on Market Research Data and EPA 2015a

. There are important uncertainties with this estimate. The actual acreage treated with paraquat may differ, since EPA has little data on desiccant uses other than cotton and potato
. The wage rates, especially for commercial applicators, may not reflect those ofapplicators applying paraquat in an agricultural section, as they were taken from a document that attempts to estimate the wages of all commercial applicators. Wages may differ for commercial applicators in lawn care, for example, and agricultural custom applicators. There are a range ofestimates for how much acreage an applicator can treat in an hour, and we chose a relatively low one; higher treatment rates would lower the cost estimate

. Also, we implicitly assume here that acreage treated by people supervised by private applicators will instead be treated by private certified Page 7 of 9applicators

. It may be that, instead, commercial certified applicators will be hired at lower cost than private certified applicators. Paraquat-specific Applicator Training Material Mitigation measure: Given the highly toxic nature ofparaquat and a history ofmisuse, EPA is requiring the technical registrants to develop comprehensive, paraquat-specific training materials for applicators

. These training materials should consist ofinformation highlighting paraquat toxicity and the risks associated with the use and misuse ofparaquat in addition to appropriate handling, storage, disposal, and PPE requirements and instructions. All applicators handling paraquat dichloride should take the training which will be available online and retain documentation ofsuccessful completion

. EPA's intention is for the training website to be listed on all paraquat dichloride product labels and successful completion to be a condition ofuse.
Potential impacts: For the proposed changes to the standards for certification ofpesticide applicators, EPA estimated the cost ofdeveloping training materials (EPA 2015b) for certified applicators ranging from $3, 100 to $4,700, depending on the length oftraining required. The estimates were based on the amount ofstafftime it would take to revise the materials, with a staffwage of$39 per hour (EPA 2015b, based on information from the Bureau ofLabor Statistics). The task ofdeveloping or adapting training materials for a 12 hour training session was estimated to take 100 hours ofstafftime, for a total cost ofabout $3,900 dollars every two years. We use that estimate for the cost ofdeveloping paraquat-specific training materials, as well. The estimate for the certification rule was based on materials were for training applicators on all the topics within a certification category, rather thanjust safe use ofone particular pesticide

. However, those costs were based on adapting existing material for training programs. Although safety information for paraquat and the closed systems already exist, they would need to be adapted

. In addition, the mitigation proposal suggests that a website training be available, so 100 hours ofstafftime seems like an appropriate estimate. We do not include additional cost estimates for tracking or monitoring the status ofcertified applicators, however. The cost of $3,900 per developed training is a one-time cost, but it may need to be duplicated ifmore than one closed system is used for paraquat containers.

References EPA 2015

. U

.S

. Environmental Protection Agency. Economic Analysis ofthe Agricultural Worker Protection Standard Revisions RIN 2070-AJ22. Docket: EPA-HQ-OPP-2011- 0184. September 2015. Available here: http:/ /www.regulations.gov/contentStreamer?documentld=EPA-HQ-OPP-2011-0 l 84- 2524&disposition=attachment&contentType=pdf

Page 

### 8 of9EPA 20l 5a. Economic Analysis ofProposed Amendments to 40 CFR Part 171: Certification of Pesticide Applicators. Docket ID: EPA-HQ-OPP-2011-0183. August, 2015. Available here: http://www.regulations.gov/contentStreamer?documentld=EPA-HQ-OPP-201 lO

183-0043&attachmentNumber= 1 &disposition=attachment&contentType=pdf EPA 20 l 5b. Certification Rule Economic Analysis Appendix A: Detailed Information on Cost Estimates. August, 2015. Available here: http://www.regulations.gov/contentStreamer?documentid=EPA-HQ-OPP-2011-0l 83- 0043&attachmentNumber=2&disposition=attachment&contentType=pdf Industry Communication, 2015. Proprietary pricing data provided by a manufacturer of chemical packaging and delivery systems, July 10, 2015 Market Research Data (MRD) (1998-2008).Data collected and sold by a private market research firm. Data collected on pesticide use for about 60 crops by annual surveys ofagricultural users in the continental United States. Survey methodology provides statistically valid results, typically at the state level. Giles, K, and R Billing. 2013. Designs and Improvements in Closed Systems. Report to K Everett, Pesticide Enforcement Branch, Department ofPesticide Regulations, California

. 13pp. Iowa State University, 2002. Estimating the Field Capacity ofFarm Machines. April 2002. Available here: https://www.extension.iastate

.edu/agdm/crops/pdf /a3-24.pdf Lazarus, William F. Machinery Cost Estimates, University ofMinnesota Extension, June 2013. Available here: http:/ /sheboygan.uwex.edu/files/2010/08/Machinery-Cost-Estimates.pdf University ofIllinois, undated. Machinery Economics, FAST Tools and Resources

. Available here: http ://www.farmdoc.illinois.edu/fasttools/spreadsheets/programdescriptions/machineryec onomics.pdf

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