2 Table of Contents

Overview

................................ ................................ ................................ ................................ ......... 1

1. Background

................................ ................................ ................................ ............................. 3

a. Status of International Review and Ot her Regulatory Action

................................ ............. 4

b. Use/Usage Information

................................ ................................ ................................ ........ 4

c. Toxicity

................................ ................................ ................................ ................................ 5

d. Incidents

................................ ................................ ................................ ............................... 6
OPP’s Incident Data System (IDS)

................................ ................................ ......................... 6

SENSOR

- PESTICIDES

................................ ................................ ................................ .......... 7

Other Incident Databases

................................ ................................ ................................ ........ 9

e. Incident Rate Analysis

................................ ................................ ................................ ......... 9

Data Sources

................................ ................................ ................................ ......................... 10

Statistical Method

................................ ................................ ................................ ................. 10

Results of Analysis

................................ ................................ ................................ ............... 11

f. Agricultural Health Study

................................ ................................ ................................ .. 13

2. Summary of Risks

................................ ................................ ................................ ................. 14

3. Proposed Interim Mitigation Decision

................................ ................................ .................. 14

a. Label Amendments and Supplemental Warning Materials

................................ ............... 14

b. Training Materials

................................ ................................ ................................ .............. 15

c. Prohibition of Applications with Hand

- held Equipment

................................ ................... 15

d. Closed System Requirement

................................ ................................ .............................. 17

e. Restrict Use to Certified Applicators

................................ ................................ ................. 18

4. Proposed Implementation Timeline

................................ ................................ ...................... 20

5. References

................................ ................................ ................................ ............................. 22

6. Appendices

................................ ................................ ................................ ............................ 23

Appendix A. Paraquat Dichloride Ingestion Risk Message for Pesticide Applicators.

............ 23
Appendix B. C ase Descriptions of 31 Moderate Severity Occupational Incidents Occurring
Between 1998 and 2012.

................................ ................................ ................................ ........... 26

Appendix C. Paraquat/Diquat/Glyphosate/Glufosinate Incident Query Methodology

............ 32
Appendix D. Supplemental Incident Rate Tables

................................ ................................ ..... 33

Appendix E. Proposed Label Amendments

................................ ................................ .............. 34

Appendix F. Summary of Proposed Supplemental Warning Materials

................................ .... 353 

### 1. BACKGROUND

Paraquat dichloride (also referred to as paraquat) is an herbicide and desiccant classified as a restricted use pesticide (RUP) due to high toxicity and, thus, associated concerns for human safety

. Animal testing indicates that paraquat is acutely toxic through all routes of exposure. A large number of human incidents inv olving the ingestion of paraquat

, both accidental and intentional, have been reported to EPA through local poison control centers, mandatory Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports from registrants,
other federal and state health and environmental agencies, and individual consumers. Toxicity
information indicates that o ne sip can be lethal and there is no known antidote. Paraquat is a known suicide agent ; moreover, there is a disproportionately high number of death s resulting
from the accidental ingestion of paraquat 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 of worker inc idents involving leakage or accidental spray in occupational settings.

In the late 1980’s, several “safening” agents such as blue dye, a stenching agent, and an emetic were added to all paraquat formulations in an effort to decrease the number of inciden ts of
accidental and intentional ingestion. The 1997 Re re gistration Eligibility Decision 1 ( RED ) noted a decline in the number of incidents, which was presumed to be associated with the “safening”
agents. Several mitigation actions required by the RED were specifically intended to lessen the occupational and ecological risks posed by paraquat, including: a reduction in maximum application rates; additional p ersonal protective equipment (PPE) for mixers and loaders; reduction of paraquat concentration in backpack sprayers; and spray drift control measures. All
paraquat p roduct labels clearly and prominently prohibit pouring paraquat into food or beverage containers via the statement “NEVER PUT INTO FOOD, DRINK OR OTHER CONTAINERS”
and “DO NOT REMOVE CO NTENTS E XCEPT FOR IMMEDIATE USE ” in an effort to eliminate the illegal transfer of paraquat.

T he 2011 EPA Office of Pesticide Programs (OPP) Registration Review Human Health Risk Scoping Document 2 focused on inhalation exposure scenarios for registered uses, including occupational handler scenarios and residential bystander inhalation risk from off

- target drift. Human incidents were reviewed and a moderately high frequency of incidents was found. I n 2013

, 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 of paraquat incidents.

At this time, EPA engaged the technical registrants in discussions of potential mitigation measures to address paraquat incidents. While these discussions were ongoing, EPA produced a paraquat safety message which describes the findings of eight incident reports citing deat hs due
to the accidental i ngestion of paraquat dichloride to illustrate why pesticide applicators should not store pesticides, especially paraquat

, in beverage or food containers. This safety message was
distributed with corresponding slides to a listserv of pesticide safety educators in December 2014

as an interim warning while m itigation discussions between EPA and the registrants were ongoing. This safety message can be found in Appendix A of this document and in the paraquat dichloride public docket.

1 Available at http://www3.epa.gov/pesticides/chem_search/reg_actions/reregistration/red_PC

- 061601_1

- Aug

- 97.pdf

2 Available in the public docket with the docket ID: EPA

- HQ

- OPP

- 2011

- 0855

- 00044 a. S TATUS OF I NTERNATIONAL R EVIEW AND O THER R EGULATORY A CTION

Paraquat dichloride is a chemical of interest to pesticide regulatory authorities around the world

. Paraquat is banned in 32 countries

, including the European Union

, based largely on human
health c oncerns.

On December 23 2015, Canada’s Pest Management Regulatory Agency (PMRA) published a Special Review Decision 3 on paraquat highlighting human health risk and incident reports on both ingestion and occupational exposure. The decision addressed public comments on the September 2015 proposed Special Review Decision 4 and listed the mitigation measures required to address paraquat human health concerns including: 1) designation of paraquat as a “restricted class” pesticide, 2) label amendments requi ring additional PPE requirements and additional hazard warnings, 3) prohibition of tank mixing 4) a reduction in concentration of the active ingredient paraquat, 5) modified packaging, and 6) the development of a stewardship/outreach program for applicator s and vendors. EPA ’s proposed mitigation measures, discussed in this document, are largely consistent with PMRA’s mitigation a pproach, although EPA does not intend on requiring a reduced concentration of the active ingredient.

In January 2014

, the Califo rnia Department of Pesticide Regulations (CDPR) ranked paraquat as second on their Priority List for risk assessment due to occupational exposure concerns 5

.

The Center for Disease Control’s National Institute for Occupational Safety and Health (NIOSH)

r ecently authored an article about human health incidents involving paraqua t and diquat. The paper analyzes information from three incident databases, concluding that all of the incidents resulting in serious i njury or death were preventable. The article al so p resent s mitigation suggestions. The article became available online 6 on January 11, 2016 and it will be available in print in April 2016.

b. U SE /U SAGE I NFORMATION

Paraquat is a rapidly acting non

- selective contact herbicide and desiccant registered to c ontrol
broad

- leaf weeds and grasses on over 100 different crops

. A gricultural uses include row crops, orchard crops, fruits, and vegetables. Non

- agricultural uses include rights of way, pastures/fallow land, and commercial buildings/storage yards. It is us ed as a desiccant/harvest aid on cotton, potatoes, tomatoes, dry beans, soybeans, sunflower, canola, sugarcane, and pine trees. Although
EPA has limited usage da ta for many of these use sites, EPA has paraquat usag e data on approximately 50 crops

. A n average of 4 million pounds of paraquat were applied annually to
over 7 million acres between 2011 and 2013. There are no products registered for homeowner use and no products registered for application to residential areas.

The fast action of paraquat allows more than one crop to be planted in a single growing season. Paraquat is also an effective desiccant . According to the Weed Science Society of America (WSSA) herbicidal mechanism of action classification, paraquat belongs to G roup 22. The

m e chanism of action of this class of herbicide is the inhibition of the photosynthesis process. The

3 http://www.hc

- sc.gc.ca/cps

- spc/pubs/pest/_decisions/rev2015

- 14/index

- eng.php#a1

4 http://www.hc

- sc.gc.ca/cps

- spc/pest/part/consultations/_rev2015

- 10/index

- eng.php

5 http://www.cdpr.ca.gov/docs/dept/prec/2014/011714_risk_assess_prioritization_update.pdf

6 http://www.sciencedirect.com/science/article/pii/S00139351163000325 activity of paraquat depends on sunlight with affected plants quick ly wilting and desiccating

. Five weed species have developed resistance to paraquat in the United States , including horse

weed ( Conyza bonariensis and Conyza canadensis ), goosegrass ( Eleusine indica ), dotted duckweed ( Landoltia punctata ), and American black nightshade ( Solanum americanum )

. C ombinations of other herbicides can be us ed as alternatives for paraquat. T he closest alterative
herbicides to paraquat are glufosinate and glyphosate.

c. T OXICITY

The phases of paraquat toxicity as well as potential medical treatments are described in the Recognition and Management of Pe sticide Poisonings b ook (Reigart and Roberts, Chapter 12, 6 th

edition

, 2013). The EPA’s OPP has sponsored the series since 1973. The manual provides healthcare professionals with current consensus recommendations for treating patients with pesticide

- relate d illnesses or injuries.

Paraquat is known to have life

- threatening effects on the gastrointestinal tract, kidney, lungs and other organs. The oral LD 50 estimate in humans varies from as little as 3

- 5 mg/kg to 40 mg/kg,
which in either case is a 10

- 15 m l sip of a 20% paraquat solution. Clinical signs, shock, and death may occur within hours to a few days. However, another source indicates patients that ingest less than 20 mg/kg usually recover fully ( Poisoning and Overdose , 6 th edition, Chapter 122).

T he lung is the primary target organ through all routes of exposure . The primary mechanism of toxicity is through the generation of free radicals which results in lipid peroxidation and cell damage to lung tissue. Acute lung edema and early lung damage may occur within the first few hours. However, hemorrhage and edema f luid in the lung results in a progressive decline in oxygen capacity with eventual death from asphyxia and tissue anoxia.

Ingestion of paraquat also causes damage to kidney proximal renal tubules which impairs the ability of the kidney to clear paraquat from the blood. Necrosis of muscle tissue including myocardium of the heart and skeletal muscle are also main features of paraquat poisoning. Cerebral edema and brain damage has also been reported in paraquat deaths.

In rodents, technical grade paraqua t is severely toxic following acute exposure via the dermal and inhalation routes (Category I) and toxic by the oral route of exposure (Category II). It is a
dermal and ocular irritant but is not a skin sensitizer. Formulat ed paraquat products range from Category I to Category IV, depending on the percent cation and route of administration in the toxicity studies . However, it is noted that the repeat dermal rabbit study with Ortho paraquat concentrate (34.4%) resulted in scabs at the treatment site as well as epidermal necrosis, ulceration, acanthosis (thickening of the epidermis), and surface exudation (oozing of fluids) of
the rabbit skin.

In agricultural workers, is it reported that dermal exposure to concentrated paraquat results in localized injury a t point of contact. Paraquat causes hands to become dry and fissured with horizontal ridging of fingernails. Chronic dermal exposure may even result in the loss of fingernails. Prolonged contact with skin typically creates ulceration and abrasion sufficien t to allow systemic absorption, resulting in other pathologic processes. Fatal poisonings have been reported from protracted dermal contamination of abraded or eroded skin.

Inhalation exposure through prolonged spray droplets may cause nosebleeds due to localized6 damage in the nose. However, systemic toxicity generally does not result due to the low vapor pressure and lower percent formulations in the field.

Table 1

. Acute Toxicity Profile

– Paraquat Dichloride 7 8

Guideline
No. Study Type [species] MRID(s) Results a Toxicity Category

870.1100 Acute oral [rat] 00054573
43685001 LD 50 = 189 (M) or 125 (F) mg/kg II

870.1200 Acute dermal [rabbit] 00054574 LD 50 = 174 mg/kg (M) I

870.1300 Acute inhalation [rat] 9 00046105 LC 50 = 1 μ g/L (M/F) I

870.2400 Acute eye irritation [rabbit] 00054575 Severe irritation I

870.2500 Acute dermal irritation [rabbit] 00054576 Slight to severe irritation; PIS = 2.1 III

870.2600 Skin sensitization [guinea pig] 00155289 Negative

--

d. I NCIDENTS

For the purposes of this analysis, the EPA queried OPP’s Incident Data System (IDS), Sentinel Event Notification System for Occupational Risk (SENSOR)

- Pesticides, National Pesticide Information Center (NPIC), and CDPR’s Pesticide Illness Surveillance Progr am (PISP)
databases. Only those cases occurring in the United States were considered in this analysis.

OPP’s Incident Data System (IDS)

OPP’s IDS includes reports of human health incidents from various sources, including mandatory Federal Insecticide, Fu ngicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports
f rom registrants, other federal and state health and environmental agencies, and individual consumers. Since 1992, OPP has compiled these reports in IDS. IDS contains reports from
across the United States, and most incidents have all relevant product information recorded. Reports submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in the report.

IDS records incidents in one of two modules: Main IDS and Aggregate IDS:

• Main IDS contains incidents resulting in higher severity outcomes and provides more detail with regard to case specifics. This system stores incident data for death, major and moderate incidents, and it includes information about the location, date and nature of the incident. Main IDS incidents involving only one active ingredient (as opposed to

7 Table taken from D415809

8 The acute dermal ( MRID 43685002), eye ( MRID 43685003) and dermal ( MRID 43685004) irritation and sensitization ( MRID 43685005) studies are not displayed above since these studies resulted in lower toxicity and
thus reduced toxicity category, likely due to a smaller percent of active ingredient used in the studies ( D217134).

9 The test material used in the acute inhalation study was crystalline paraquat dichloride. Purity was not specified, but the purity of crystalline paraquat dichloride used in other studies was 99.9%. The test material used in t he other studies was paraquat dichloride in the form of ORTHO Paraquat Concentrate 3 (end use product containing 34.4% paraquat cation). Results are expressed in terms of paraquat dichloride rather than paraquat cation.7 pesticide products with multiple active ingredients) are considered to provide more certain information about the potential effects of expos ure from the pesticide.

• Aggregate IDS contains incidents resulting in less severe human incidents (minor, unknown, or no effects outcomes). These are reported by registrants only as counts in what are aggregate summaries.

A query of Main and Aggregate ID S for all available years (1990

- 2014) identifies a total of 276 and 342 incidents involving paraquat, respectively. The Main IDS query include d 27 deaths involving paraquat dichloride between 1990

- 2014 . Twenty

- two of these deaths involved the ingestion of paraquat; 11 deaths resulted from intentional ingestion, 8 deaths resulted from accidental ingestion . For the remaining 3 deaths , it was not clear whether the ingestion was
accidental or intentional . Two of the paraquat deaths in Main IDS were related to a n incident in which paraquat was mistaken for 2,4

- D and a drift event ensued . Th e th ree remaining paraquat fatalities had unclear or unknown exposure circumstances. Since the time of the incident report, IDS has received reports of two additional accidenta l ingestion deaths in the United States.

The Main IDS query included 22 high severity incidents involving paraquat dichloride. Nine cases were occupational in nature and generally involved dermal exposure. Four major severity
cases were due to accidental ingestion, one case was a suicidal ingestion, one case was related to bystander drift, and seven cases were unclear or lacked case descriptions.

181 moderate severity paraquat cases were identified in the Main IDS query. M oderate paraquat exposure incid ents are typical handler/product user related exposures involving splashes, spills or equipment malfunction during the handling of the product, including mixing, loading or applying the product or cleaning application equipment. Most cases appear to have t aken place on a farm, which often was the residence of the farmer/applicator; however location and occupational information was often sparse in the case reports. Symptoms of the moderate severity paraquat incidents were typically dermal irritation includin g blisters, rashes, and redness, followed by ocular exposures. Symptoms generally resolved within several days

. H owever, there are a few reports of skin irritation persisting over a long period of time following a paraquat exposure and a few reports of inj uries from occupational exposures necessitating skin grafts. Since the time of this analysis, EPA has received three additional reports of incidents resulting in paraquat related
deaths in IDS.

SENSOR

- PESTICIDES

The Center for Disease Control’s National Institute for Occupational Health (CDC/NIOSH) manages a pesticide surveillance program and database known as SENSOR

- Pesticides. This database includes pesticide illness case reports in 12 states from 1998

- 2012. The participating states for a given year v ary depending on state and federal funding for pesticide surveillance. Cases of pesticide

- related illnesses are ascertained from a variety of sources, including: reports from local Poison Control Centers, state Department of Labor workers’ compensation cla ims when reported by physicians, reports from State Departments of Agriculture, and physician reports to state Departments of Health. Although both occupational and non

- occupational incidents are included in the database, the SENSOR coordinators primarily focus their follow

- up case investigation efforts on the occupational pesticide incidents. The state SENSOR coordinator at the Department of Health will follow

- up with cases and obtains medical records to verify symptoms, circumstances surrounding the expo sure, severity, and outcome. Using standardized protocol and case definitions, SENSOR coordinators at State Departments of Health8 enter the incident interview description provided by the case, medical report, physician and patient into the SENSOR data sys tem. All SENSOR

- Pesticide cases must report a minimum of two health effects in order to be included in the aggregate database that EPA uses for incident analyses.

A query of SENSOR

- Pesticides 1998

- 201 2 identifies a total of 155 cases involving paraquat (pc codes 061601 and 061603); 114 of these cases involve a single active ingredient and 41 involved multiple active ingredients. After removing intentional cases (n=4) there are 151 SENSOR

Pesticide cases for review. There was one fatalit y, three high se verity cases, 38 moderate severity cases, and 110 low severity cases. In terms of care sought by cases, 64 cases were seen at an emergency room or hospital (42%), 68 went to a doctor’s office (45%), nine called poison control, five sought no care, and fiv e were other or unknown.

The most frequent routes of exposure 10 are dermal (n=74), ocular (n=58), and inhalation (n=41).
Twelve SENSOR

- Pesticides cases resulted from ingestion, including the fatality. This fatal case
was an 8

- year old child who accidenta lly drank paraquat that had been transferred into a soda
bottle and stored in his family’s garage. T hree ingestion cases involved siphoning of paraquat by
mouth.

The most commonly affected body systems for paraquat cases are ocular, nervous system, and dermal symptoms. Eye pain/irritation/redness is the most frequently reported symptom, followed by headache and skin redness/first degree burn.

Of the 151 cases, 123 cases (81%) are work

- related and 28 cases (19%) are not work

- related. Of
the 12 3 work

- rel ated cases, 31 moderate in severity cases and these cases are described in Appendix B. It is important to characterize these occupational cases because paraquat is an RUP intended for occupational use only by certified applicators (or those under direct s upervision of a certified applicator).

Of cases with a known application site (n=131); 10 7 cases occurred on farm s or nurseries

. Fourteen cases were made exposed and made ill at private residences . Of the cases with a known activity at the time of ex posure (n=135); 71% of cases were handling the pesticide, handling includes: application (n=96), mixing/loading, transporting, or repairing pesticide application equipment. The other 29% of cases were conducting routine work or living activities
at the ti me of exposure.

126 of the 151 cases had at least one prevention code (factor contributing to case’s illness that could have been prevented) assigned 11

. It is noteworthy that 41 cases had the contributing factor “required eye protection was not worn or the required ey e protection was inadequate ” ( e ye pain as the lead symptom supports this issue). In 20 cases , application equipment failure caused or
contributed to the incident.

10 Cases may report multiple routes of exposure.

11 In 2009, SENSOR

- Pesticides began requiring prevention coding for cases that had an identifiable contributing factors, such as: early re

- entry, PPE not worn, spill/splash, equipment failure, improper storage, drift, etc. Cases may have multi ple prevention codes.9 Other Incident Databases

The National Pesticide Information Center ( NPIC ) prepared a special report of paraquat incidents
from 1/1/07

– 5/31/13 . T here a total of four cases; no fatalities were reported

. H owever, one case involved paraquat ingestion from a suicide attempt. CDPR confirmed that from 1992

- 2010, there
were a total of four paraquat ingestion cases reported (out of 101 total paraquat

- related cases reported) to the Pesticide Illness Surveillance Program, three of which resulted in death. In their 10/7/13 letter to EPA, the American Association of Poison Control Centers noted a total of 50 paraquat deaths reported to the National Poison Data System (NPDS) from 1983 to 2011. Of the
50 deaths

, 33 were intentional exposures ( suicides ) , 15 were due to unintentional exposure, and

two were of unknown cause

.

For more informati on on human ingestion incidents, refer to Paraquat Dichloride: Review of Human Ingestion Incidents , dated May 21, 2014 in the Registration Review docket for paraquat dichloride (Docket ID: EPA

- HQ

- OPP

- 2011

- 0855).

e. I NCIDENT R ATE A NALYSIS

In 2015, the EPA conducted an incident rate analysis which compared p araquat incidents to incidents associated with comparable chemicals. Three herbicides

, gly phosate, glufosinate, and diquat, were selected for this comparison because they are potential paraquat al ternatives for the
herbicidal use

. Th e detailed incident rate analysis is available in the docket (EPA

- HQ

- OPP

2011

- 0855)

.

Glufosinate is a non

- selective systemic herbicide that can be used as a burn

- down treatment before planting or emergence of any conve ntional crops. In addition, glufosinate can be applied
as a post

- emergence treatment to manage weeds in fields planted with herbicide resistant crop varieties such as corn, canola, cotton, soybean, and sugar beet. According to the WSSA
mechanism of action classification, glufosinate belongs to Group 10. Herbicides of this family inhibit the enzyme glutamine synthetase in plants, leading to a complete breakdown of ammonia metabolism and consequent inhibition of photosynthesis. Only one weed species, Italian ryegrass ( Lolium multiflorum ) has developed resistance to glufosinate in the United States.

Glyphosate (N

- (phosphonomethyl) glycine) is also a non

- selective contact

- type herbicide used to manage annual and perennial weeds in many crops. As a burn

- down tre atment, glyphosate is applied before cultivation of crop lands to control the existing weeds in the field. It is absorbed through foliage and translocated to growing points. According to the WSSA herbicide mechanism of action classification, this herbicide belongs to Group 9. The mechanism of action of this herbicide is inhibition of the (EPSP) 5

- enolpyruvylshikimate

- 3

- phosphate enzyme involved in biosynthesis of aromatic amino acids (phenylalanine, tyrosine, and tryptophan).
These amino acids are essential for the protein synthesis in plant species. There are 15 confirmed weed species in the United States that have developed resistance to glyphosate and over 100 resistant weed species worldwide.

Diquat dibromide is a non

- selective fast

- acting postemergence herbicide registered on numerous agricultural crops and for homeowner use. Its primary agricultural use is as a desiccant. Other important uses are for the control of aquatic weed and for spot weed control in reside ntial settings. According to the WSSA mechanism of action classification, diquat dibromide belongs to Group 22. Herbicides of this family are Photosystem I electron diverters that ultimately destroys the integrity of cell membranes, leading to rapid leaf wilting and desiccation.10 D ata Sources

Single active ingredient incident case reports in the SENSOR database for the four herbicides
between 1998 and 2011 were included in this analysis. Any intentional exposure or multiple active ingredient cases were excluded. Only SENSOR inciden t case reports with farm or agricultural use sites recorded were included in the analysis because t he survey usage data used to normalize the incident counts was agricultural in nature. Table 1 below summarizes the cases included in the incident rate analy sis.

The use/usage data was obtained from an agricultural marketing firm which produces survey estimates regarding use/usage data. Three normalization parameters were chosen, including the
amount of active ingredient (a.i.) used in pounds , t he area treated with the a.i. in acres , and the (estimated) number of people using the a.i. ( projected number of survey respondents) for each of the four herbicides during 1998

- 2011 period (all values represent the totals over these years and are rounded)

. These data reflect the same time period over which the incidents were accumulated and was restricted to the specific states participating in the SENSOR program 12 . The three normalization factors can be considered as rough measures of the geographical exten t of the use (acres treated), the intensity of use (pounds applied) and the number of users (projected sample) and can be seen on the right hand side of Table 2

.

Table 2

. SENSOR

- Pesticides Case Counts / Agricultural Use Data

a.i. Number of Incidents
Of Given Severity
(numerator) Usage Metric
(denominator)

High Moderate Low Total Pounds used Acres applied Respondents

Diquat 0 0 3 3 70 0

, 000 2, 200

, 000 9, 500

Glufosinate 0 1 4 5 13, 6 00

, 000 30, 300

, 000 140, 000

Glyphosate 0 24 124 148 732, 00 0

, 000 87 0

, 000

, 000 2, 400

, 00 0

Paraquat 1 19 52 72 2 7

, 000

, 000 58, 000

, 000 2 00

, 000

Statistical Method

A Poisson regression model was used to estimate and compare the incident rates between the herbicides. The number of incidents were normalized by setting the total amount of a.i. used (expressed per unit of 100,000 pounds), the total areas treated (in uni ts of 100,000 acres), and the number of respondents (in thousands) as offset values in the models (i.e. using as denominators to calculate incident rates).

Two different incident rates were estimated through two separate analyses: (i) incident rates of cases including only high and moderate severity outcomes; and (ii) incident rates of all cases including high, moderate and low severity outcomes. The differences in incident rates among the herbicides were estimated and presented in terms of incident rate s ratios (IRRs).

12 SENSOR states included: Arizona, California, Florida, Iowa, Louisiana, Nebraska, New Mexico, New York, North Carolina, Michigan, Oregon, Texas, and Washington.11 In addition, a second analysis of the data was performed which explores the tendency of one pesticide to have a systematically more severe outcome given a case than another pesticide. This potential for a systematic “shift” towards more severe cases was ev aluated by using a proportional odds (aka ordinal logistic regression) model. The tendency toward a case resulting in a more severe outcome with one herbicide compared to another is expressed in terms of an estimated odds ratio. For example, if an odds r atio > 1 is produced when herbicide “X” is compared to herbicide “Y”, this indicates that incidents associated with exposure to herbicide “X” are more likely to be more severe than incidents associated with exposure to herbicide “Y”.

Results of Analysis

The estimated incident rate of cases for high 13 and moderate severity 14 outcomes of the herbicides are presented in Table 3

.

Table 3

. Incident Rate for High & Moderate Severity
SENSOR

- Pesticides Case s

a.i. Incident rate per 100,000 pounds applied Incident rate per 100,000 acres treated Incident rate per 1,000 respondents

Diquat 0.000 (NA, NA) 0.000 (NA, NA) 0.000 (NA, NA)

Glufosinate 0.007 (0.001, 0.052) 0.003 (0.000, 0.023) 0.007 (0.001, 0.050)

Glyphosate 0.003 (0.002, 0.005) 0.003 (0.002, 0.004) 0.010 (0.007, 0.015)

Paraquat 0.075 (0.048, 0.116) 0.034 (0.022, 0.053) 0.092 (0.059, 0.143)

T he results in Table 3 indicate that the incident rate for incidents classified as having high and moderate severity outcomes for paraquat are 0.075 incidents per 100,000 lbs used. Alternatively, these rates can also be expressed in terms of acres treated and rate per 1000 resp ondents and

– when expressed in this way

– are 0.034 incidents per 100K acres treated or 0.092 incidents per 1000 respondents. These rates are substantially higher than those for glyphosate, glufosinate, and diquat.

These comparisons can also be useful ly expressed as incident rate ratios (IRRs) along with the 95% confidence intervals which is standard practice in the descriptive epidemiology literature. For high and moderate severity outcomes, these IRRs are presented in Table 4

. Note that diquat
is not included in Table 4 because there are no reported incident with high or moderate severity
outcomes in SENSOR.

13 SENSOR defines “high” severity cases as “The illness or injury is sev ere enough to be considered life threatening and typically requires treatment. This level of effect commonly involves hospitalization to prevent death.”

14 SENSOR defines “moderate” severity cases as cases of less severe illness or injury often involving s ystemic manifestations. Generally treatment was provided.12 Table 4 . Comparisons of Incident Rate Ratio for High & Moderate Severity Outcomes
SENSOR

- Pesticides Cases

per 100,000 pounds per 100,000 acres applied per 1,000 respondents

Comparison Incident Rate Ratio (95% CI) P

value Incident Rate Ratio (95% CI) P

value Incidence Rate Ratio (95% CI) P

value

Glufosinate vs. Glyphosate 2.24 (0.30, 16.54) 0.4301 1.20 (0.16, 8.88) 0.8576 0.71 (0.10, 5.24) 0.7359

Paraquat vs. Glufosinate 10.21 (1.37, 76.11) 0.0233 10.37 (1.39, 77.30) 0.0224 12.98 (1.74, 96.70) 0.0124

Paraquat vs. Glyphosate 22.85 (12.62, 41.36) <.0001 12.46 (6.88, 22.55) <.0001 9.20 (5.08, 16.65) <.0001

The results in Table 4 show that the incident rate of high and moderate severity outcome cases for paraquat was significantly higher than that of g lufosinate or g lyphosate using any of the three methods for normalizing exposure. For example, the incident rate for high and mod erate severity outcomes normalizing by amount a.i. used for paraquat is about 10.21 times greater than the corresponding rate for glufosinate and 22.85 times that of g lyphosate.

The estimated incident rate for all cases including high, moderate, and low severity outcomes are presented in Table B1, while the comparisons of incident rates of all cases including high, moderate, and low severity outcomes among the herbicides are presented in Table B2 in Appendix D

.

Finally, the analysis of the tendency for exposure of one pesticide to result in a systematically more severe outcome compared to another pesticide using the numbers of SENSOR

- Pesticides incidents are presented in Table 5

.

Table 5 . Comparison of tendency of more severe outcomes

Comparison Odds Ratio (95% CI) P

- value

Glufosinate vs. Glyphosate 1.290 (0.267, 6.222) 0.7512

Paraquat vs. Glufosinate 1.562 (0.320, 7.626) 0.5812

Paraquat vs. Glyphosate 2.015 (1.251, 3.245) 0.0039

The results in Table 5 show that reported cases associated with paraquat exposures tended to be more severe than cases associated with g lyphosate ( 2.02 (1.25, 3.25)) . More specifically, the odds of a random case associated with paraquat to be more severe than one associated wi th glyphosate was a statistically significant 2.015, or approximately twice as likely . Comparing paraquat with glufosinate, on the other hand, produced a non

- significant Odds Ratio of 1.56 (95% CI: 0.320, 7.626).13 f. A GRICULTURAL H EALTH S TUDY

The Agricult ural Health Study ( AHS ) is a high quality, prospective epidemiology study evaluating the link between pesticide use and various health outcomes including cancer ( m ore information is available at http://www.niehs.nih.gov/research/atniehs/labs/epi/studies/ah s/) . The AHS includes private and commercial pesticide applicators and their spouses. If there are AHS findings relevant to a particular pesticide going through registration review, the Agency ensure s those findings are considered in the problem formulatio n/scoping phase of the process and, if appropriate, fully reviewed in the risk assessment phase of the process. The AHS includes information on use of 50 different pesticide active ingredients commonly used in agriculture.

The following AHS review information is taken from the 2011 paraquat dichlor ide incident and epidemiology scoping memo (D392273) . Since that time

, more epidemiolo gical findings have published. There is a large body of epidemiology data on paraquat dichloride use and
Parkinson’s di sease. For the purposes of this current incident review, only acute exposure to paraquat dichloride has been considered. However, as part of the comprehensive human health
risk assessment scheduled for 2017, chronic effects will be reviewed.

In the AH S, the authors have reported notable associations between paraquat and the following endpoints : thyroid disease; Parkinson’s disease ; two respiratory outcomes (wheeze and chronic bronchitis) among non

- smoking women; and an evaluation of all cancers in rela tion to paraquat use over the lifetime. With the exception of the research study on Parkinson’s disease , all investigations were preliminary, and not based upon prior knowledge of a role for paraquat ( i.e.,

no a priori ) hypotheses. Animal studies and other epidemiologic evaluations have suggested that paraquat (and also the pesticide rotenone) may be causative agents (or contributors) in the etiology of Parkinson’s disease . Strengths of the AHS epidemiology study include its large sample size, and prospecti ve nature of the data collection, as well as high response rate; limitations include the narrow generalizability of the results (primarily performed among white, male, pesticide applicators), and lack of knowledge of exposure periodicity and time of cessat ion of exposure. Results are briefly summarized below.

In two AHS studies, modest associations were observed between paraquat, as well as other pesticides, and both wheeze (OR 1.27 (95% CI 1.04, 1.56), and chronic bronchitis (among non

smoking women) (OR 1.91 (95% CI 1.02, 3.55)). Overall, these studies are not strongly supportive of a link between paraquat and respiratory health outcomes measured, ; exposure measurement error may explain these results

. EPA will continue to monitor this literature through the registration review process. In addition, while there is limited a priori evidence as to a role for paraquat in thyroid disease, authors reported a statistically

- significant elevated odds of hypothyroidism (under

- active thyroid gland) among women who r eported exposure to paraquat (OR 1.8 95% CI 1.1, 2.8). Alternative explanations may also exist at this time, and have not been completely investigated. Concerning Parkinson’s disease , authors reported elevated odds of
Parkinson’s disease among those who used paraquat in comparison to those who did not (OR 2.5 (95% CI 1.4, 4.7)). This result is supportive of the toxicological findings. In addition, AHS authors compared cancer incidence between users and non

- users of paraquat, and did not observe strong evi dence of an association between paraquat and any cancer outcome evaluated (including all cancers combined, prostate, lung, and colon). Elevated risks were observed with respect to

non

- Hodgkin lymphoma (NHL) however, these results could be otherwise explain ed. As stated by the authors

, “There was some suggestion of a possible link between paraquat exposure and NHL risk in humans, but the inconsistency in exposure level trend suggests that this could be a chance finding ”

. In summary, based upon preliminary in vestigations within the AHS, authors14 observed some evidence of a possible role for paraquat in relation to wheeze as well as chronic bronchitis among non

- smoking women, and thyroid disease. However, at this time other explanations cannot be excluded, and a dditional replication is needed. Authors did not observe strong evidence of an association with cancer. Concerning Parkinson’s disease , recent evaluations support observations in experimental toxicology.



### 2. SUMMARY OF RISKS

The number and severity of human he alth incidents associated with paraquat dichloride is of great concern to the EPA. Based on toxicity data and incident reporting, it clear that paraquat is a highly toxic substance through all routes of exposure

-- ingestion, inhalation, and contact with

t he skin and eyes. Furthermore, paraquat is routinely misused and misuse can cause injury or fatality. Paraquat is frequently transferred to drink and other inappropriate containers, contrary to clear label directions prohibiting and warning against such tr ansfers. There are numerous incidents, many involving children, of paraquat being accidentally ingested from a beverage container. The results of such ingestion are typically catastrophic, resulting in life

- threating injury or death. Occupational incidents resulting in dermal injury severe enough to require skin grafts as a result of paraquat leaks, spills, and spraying are common with paraquat dichloride. Some fatalities have also resulted from paraquat dermal exposure.

In addition, t he AHS suggest s that chronic exposure to lower levels of paraquat plays a role in wheezing and chronic bronchitis among non

- smoking women and thyroid disease and alludes to a potential link between paraquat dichloride and Parkinson’s disease

.



### 3. P ROPOSED INTERIM MITIGATION DECIS ION

The EPA has concluded that the following mitigation measures are necessary to minimize human health incidents associated with paraquat : (1) label changes emphasizing paraquat toxicity and supplemental warning materials , (2) targeted stewardship/trainin g materials for paraquat users, (3) prohibition of application from hand

- held equipment , (4) a closed

- system requirement (similar to the lock

- and

- load system) for transferring paraquat out of all containers, and (5) restricting the use of paraquat to certi fied applicators only (i.e., prohibiting application by individuals working under the supervision of a certified applicator)

. The Agency believes that
these measures are necessary to adequately address the human health risk concerns highlighted through the paraquat incident analysis. EPA has had discussions with the paraquat technical registrants that suggest that the mitigation measures could be adopted voluntarily.

For details on the potential impacts of the following mitigation measures to include cost estimates and their sources, see the Paraquat: Potential Impacts of Proposed Mitigation

Measures document in the paraquat dichloride docket (EPA

- HQ

- OPP

- 20 11

- 0 85 5 ).

a. L ABEL A MENDMENTS AND S UPPLEMENTAL W ARNING M ATERIALS

EPA is proposing to require all p araquat dichloride product labels to be updated to highlight ingestion risk and clarify toxicity . In addition, EPA will require supplemental warning materials to be included on or with all paraquat product packages. The supplemental warning materials
will consist of (1) a warning sticker affixed to the cap of all paraquat containers with the text

“ DANGER

- ONE SIP CAN KILL” in English and Spanish accompanied by the image of a skull and crossbones symbol; (2) a “product package safety requirements sticker (PSS R) reiterating important warning statements (in Spanish, English, and pictogram form) to be affixed to the15 opposite side of the label on each paraquat container; (3) a product warning handout called a “counter card” reiterating the same important warning i nformation (in Spanish, English, and pictogram format) to be distributed with every paraquat container with the intention of the
dissemination this important information to any person who might handle paraquat. A summary of the proposed label amendments an d mock

- ups of the supplemental warning materials can be found in Appendices D and E.

b. T RAINING M ATERIALS

Given the highly toxic nature of paraquat and its history of misuse, EPA proposes requiring the technical registrants to develop comprehensive, paraqu at

- specific training materials for applicators. These training materials should consist of information highlighting paraquat toxicity and the risks associated with the use and misuse of paraquat in addition to appropriate handling, storage, disposal, and P PE requirements and instructions. All applicators handling paraquat dichloride should take the training

, which will be available online

, and retain documentation of successful completion. EPA’s intention is for the training website to be listed on all para quat dichloride product labels and successful completion to be a condition of use.

For the proposed changes to the standards for certification of pesticide applicators, EPA estimated the cost of developing training materials for certified applicators rang ing from $3,100 to $4,700, depending on the length of training required. The estimates were based on the amount of staff time it would take to revise the materials, with a staff wage of $39 per hour. The task of developing or adapting training materials fo r a 12 hour training session was estimated to take 100 hours of staff time, for a total cost of about $3,900 dollars every two years. We use that estimate for the cost of developing paraquat

- specific training materials, as well. The estimate for
the certif ication rule was based on materials were for training applicators on all the topics within a certification category, rather than just safe use of one parti cular 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 of staff time seems like an appropriate estimate . We do not include additional cost estimates for tracking or monitoring the status of certified applicators, however. The cost of $3,900 per developed training
is a one

- time cost, but it may need to be duplicated if more than one closed system is used for paraquat containers.

Guidance for Commente rs: Additional areas of information related to the training
materials requested for this proposed interim mitigation decision, and of particular interest to EPA, are described below.

• Identification of additional information that would be helpful to include in the training materials

.

• Comments related to the feasibility of this training

.

• Additional information that would be helpful in reducing exposure to paraquat

.

• Information related to the illegal trans fer and /or distribution of paraquat.

c. P ROHIBITION OF A PPLICATIONS WITH H AND

- HELD E QUIPMENT

The EPA is proposing to prohibit the use of all hand held application equipment, including backpack sprayers and hand gun sprayers, for paraquat dichloride. A large nu mber of the paraquat incidents involve backpack leaks and accidentally spraying oneself while applying16 paraquat via handgun or backpack sprayers. Incident reports note that leakage and spraying of paraquat dichloride onto skin results in severe burns which can necessitate skin grafts, and sometimes death. The anticipated impact of this mitigation measure on human health risk associated with the use of paraquat is a decrease in dermal exposure and subsequently a decrease in occupational incidents.

Prohibiti on of hand

- held equipment may cause growers to change to an alternative chemical, or mixtures of chemicals, to achieve similar weed control

.

Paraquat is a rapidly acting, broad

- spectrum, chemical used as an herbicide and as a d esiccant, with relatively ra pid burn down efficacy. Survey and extension data suggest that hand

- held applications of paraquat are made for weed control and not as a crop desiccant. Paraquat’s combination of characteristics are not found in any other single alternative herbicide. The two herbicides that are most similar to paraquat are glufosinate and glyphosate. Table 1 compares
the characteristics of these three herbicides.

Table 6. Characteristics of paraquat, glufosinate, and glyphosate

Characteristics Paraquat Glufosinate Glyphosate Weed Selectivity Non selective Non selective Non selective

Application Pre

- plant
Post directed No paraquat tolerant crops. Pre

- plant

Post

- emergence on Liberty Link crops. Pre

- plant

Post

- emergence on Roundup Ready crops

Hand

- held equipment Permitted Permitted Permitted Herbicide activity Contact Contact Systemic

Coverage Complete coverage of foliage is needed Complete coverage of foliage is needed Complete coverage of 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
interval 0 days Crop dependent (0 to 180 days) Crop dependent (0 to 30 days) Approximate cost per

acre $7.25 $11.27 $4.83

Depending on the particular combination of characteristics the grower requires, either glufosinate or glyphosate may be selected with a concomitant change in per

- acre costs. Other growers will select a combination of active ingredients to provide the desired combination of characteristics. Currently it is not possible to quantify the impacts of switching to alternatives because of limited
information on the use sites where hand

- held application equipment is commonly used. The large
number of herbicides that could be tank mi xed to achieve similar characteristics also complicates the quantification.

The use of small volumes of paraquat may indicate that growers use hand

- held equipment. Paraquat is sold in several sizes of containers ranging size from one gallon to 2,000 gal lons. 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. If true, then the prohibition of hand

held equipment in this area may have a larger regional impact.

Guidance for Commente rs: Additional areas of information related to the proposed prohibition of hand

- held applications requested for this proposed interim mitigation decision, and of particular interest to EPA, are described below.17 • Use sites whe re hand

- held application equipment is commonly used.

• Information on the hand

- held application of paraquat as a desiccant.

• Identification of the most likely herbicide mixtures that would have the similar characteristics to paraquat.

• Information related to h andheld paraquat usage in Puerto Rico.

d. C LOSED S YSTEM R EQUIREMENT

EPA is proposing that all paraquat containers be engineered so that paraquat may 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) s crew caps that can be removed allowing paraquat to be poured or siphoned from t he container are prohibited , and 3) t he 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 of the mixer or loader to the paraquat ( except for the negligible escape associated with normal operation of the system )

. The anticipated impacts of this mitigation measure on paraquat human health risk include the elimination of the opportunity for paraqu at to be illegally decanted into beverage (or any other secondary ) containers and a reduction in spills and dermal exposure thus minimizing incidents resulting from improper use of PPE and the unsafe handling of paraquat.

EPA is aware that it is common p ractice for mixers/loaders/applicators to conduct “jar tests” in
order to determine the compatibility of pesticide, fertilizer, and other chemicals applied to fields via tank mix. However, the practice of jar testing with paraquat presents an exposure conc ern as it increases the likelihood of accidental spills/splashes and the improper storage of paraquat. Jar testing will not be possible with the closed system packaging that EPA is proposing to require. In addition, j ar testing directly conflicts with the label direction, “NEVER PUT INTO FOOD,
DRINK OR OTHER CONTAINERS” . In lieu of jar testing, EPA recommends that the paraquat

t echnical registrants develop a reference material listing compatible tank mixes or new technology that would allow for safe compati bility test ing (for example, application systems which would keep the two co

- applied chemicals separate until immediately before application, or

one

- time

- use closed containers designed and labeled specifically for compatibility testing).

Requiring closed systems would require users of paraquat 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 close d system for farmers, EPA contacted an industry representative who manufactures and sells closed
systems and closed system components. The reported cost of a system that corresponded to the mitigation requirements was $500 to $700 per unit. There is also a small additional cost for closures on the pesticide container that cannot be removed an d 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 standar ds 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 com patible with what is required for paraquat.

Based on available usage data, about 25,000 f arms apply paraquat annually. Some of these farms may already have systems for handling pesticides that reduce the exposure to workers, handlers18 and applicators, but those systems may not be designed for and compatible with clo sures for paraquat containers. If all of those 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 t o $17.5
million. There is a great deal of unc ertainty 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 i s also possible that other paraquat users, faced with expensive, one

- time upgrade costs

, will either switch to alternative chemicals or hire commercial pesticide applic ators for paraquat treatments. It is also possible that paraquat manufacturers may subsidi ze the cost of new closed systems.

These estimates are l imited by uncertainties in the actual costs of closed systems, the number of applicators who would need to buy such systems, whether existing systems would be compatible with new standard closures, and any training costs associated with closed systems.

Guidance for Commente rs: Additional areas of information related to the proposed closed system requirement requested for this proposed interim mitigation decision, and of particular interest to EPA, are described below.

• Additional information on the cost of closed systems, including the number of affected parties and any training costs associated with closed systems.

• Information related to the importance of tank mixing paraquat dichloride.

• Common tan k mix combinations including paraquat dichloride.

• Information related to known compatible and incompatible tank mix combinations for paraquat dichloride.

e. R ESTRICT U SE TO C ERTIFIED A PPLICATORS

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. There are d ifferent interpretations of “supervision” on a state

- by

- state basis

. In some cases, “supervision” can mean that the certified applicator is available through a phone call. The breadth of information the EPA has on human incidents suggests that misuse , including decanting of paraquat into other
containers

, is occurring despite the current RUP classification . As a result, to be protective of human health, the EPA is proposing to restrict the use of paraquat even further, by only allowing certified applicators who have met the applicatory competency standards established by states, tribal, and federal agencies to use or handle paraquat . The anticipated impacts of this mitigation measure include decreased occupational and ingestion risk, the reduction of paraquat availability and exposure to persons not knowledgeable about the proper use and handling of paraquat , and a general decrease in misuse.

This mitigation measure would increase costs to growers to the extent that certified applicators have a higher opportunity cost of time or charge more for application services than those who currently apply pa raquat un der 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 of the proposed revisions to the standards for certified applicators, OPP has estima ted wage rates and the number of applicators by state for certified applicators and those who apply RUPs under their direct supervision. Certified pesticide applicators can either be commercial, when they apply pesticides for hire, or private if they apply pesticides on their own farm or without pay. The estimated cost for an hour of time is $52 for private certified applicators and $21 for19 com mercial certified applicators. The difference in cost for these two is based on the cost of time being higher for p rivate applicators, who are farmers and business owners. For uncertified applicators under the supervision of a certified applicator, the estimated wage rates are $18 for those supervised by commercial applicators, and $21 for those supervised by private a pplicators.

Available pesticide use data indicate that an annual average of 7.5 million acres were treated with paraquat as an herbicide from 2009

– 2014, and about 5 million of those acres were farmer applied; the remainder were applied by custom ap plicators or the applicator was not identified. In addition, paraquat is widely used as a desiccant on some cr ops, 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%) of those acres are treated by the farmer, with the rest (about 500,000 acres) treated by custom applicators

. EPA does not have information on the acreage of other crops treated with p araquat 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 fo r every hour of application being made by a certified private applicator instead of an applicator under their supervision, and $3 per hour for commercial applicators instead of an appli cator under their supervision. To estimate the amount of application ti me that would need to be substituted, we begin with available usage data, which shows about 7.5 million acres treated with paraquat annually

. There are a range of estimates of
the number of acres that can be treated b y a sprayer in an hour’s time. We use a n estimate of 10 acres per hour, which corresponds to a 20 foot sprayer, the lowest reported in that study. This is a low estimate of the number of acres 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, 44 to 46 acres per hour in Minnesota, or 55 acres per hour in Iowa. Using a low estimate of acres treated per hour will inflate the estimated costs of requiring all applications to be made by a certified applicator.

If a sprayer can treat 10 acres per hour, then nationally that requires 640,000 hours of applicator time by private applicators, and 300,000 hours by commercial applicators. If an 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.

To estimate the total cost of requiring application by ce rtified applicators only, we need to estimate the number of acres 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 w ere about 82,000 private certified applicators nationwide, and about 2,800 noncertified applicators under their supervision

. There were about 414,000 certified commercial applicators, and 947,000 uncertified applicators under the supervision of a certified applicators. If the ratio of noncertified to certified applicators reflects the proportion of paraquat acreage treated by noncertified applicators, then about 3.3% of the 6.4 million acres treated annually by private applicators and about 70% of the 3 mil lion acres treated by commercial applicators are treated by uncertified applicators under the supervision of certified 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 $1.320 million annually, almost equally divided between private (about $655,000) and commercial (about $626,000).

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 of applicators applying paraquat in an agricultural section, as they were taken from a document that attempts to estimate the wages of all commercial applicato rs. Wages may differ for commercial applicators in lawn care, for example, and agricultural custom applicators. There are a range of estimates for how much acreage an applicator can treat in an hour, and we chose a relatively low one; higher

treatment ra tes would lower the cost estimate. Also, we implicitly assume here that acreage treated by people supervised by pri vate applicators will instead b y treated by private certified applicators. It may be that, instead, commercial certified applicators will b e hired at lower cost than private certified applicators.

Guidance for Commente rs: Additional areas of information related to the proposed restriction of use to certified applicators only requested for this proposed interim mitigation decision, and of pa rticular interest to EPA, are described below.

• Information on the time needed to train and license applicators to obtain a certified pesticide applicator license.

• Information on the number of acres treated by certified applicators and the number of

acres treated by those under the supervision of a certified applicator by crop.



### 4. PROPOSED IMPLEMENTATION TIMEL INE

EPA is currently working with the technical registrants to implement the first two components of the mitigation package: (1) new labeling and supplemental warning materials; and (2) new targeted training materials. EPA anticipates that both of these risk r eduction measures will be approved and in use prior to publication of the final mitigation decision later in 2016.

The third component

– prohibition of hand

- held applications

– will occur through label amendments. To allow current paraquat users sufficie nt time to switch to alternate products for
situations where hand

- held equipment is necessary, EPA anticipates allowing registrants one year from the date of publication of the final mitigation decision for submission of revised labels prohibiting applicat ion by hand

- held equipment.

The fourth component of the mitigation

– change in packaging line to a closed system

– will require packaging design, testing, and manufacturing changes. The fifth component

– the requirement for paraquat to be applied by certi fied applicators only

– will require some current paraquat users to be trained as certified applicators or to transition to alternate products. To allow time for implementation of these two components of the mitigation, EPA is proposing to allow
paraquat r egistrants a maximum of two years from the publication of the final mitigation decision switch to new packaging and submit revised labeling to implement these two risk
reduction measures.21 Mitigation Measure Proposed Implementation Timing
Label Amendments 2016 Paraquat Specific Training Materials 2016 Prohibition of Hand Application 2017 Closed System Requirement 2018 Restricted Use to Certified Applicators 2018

Guidance for Commente rs: Additional areas of information related to the proposed implementation timeline requested for this proposed interim mitigation decision, and of particular interest to EPA, are described below.

• Information related to the feasibility of the proposed timeline and any challenges that might impact this pr oposed schedule

.22 

### 5. REFERENCES

[Amended] Paraquat & Herbicide Alternatives: Incident Rate Analysis . James Nguyen and Elizabeth Evans. January 20, 2016.

Paraquat Dichloride (Paraquat) Human Health Risk Scoping Document in Support of Registration Review . Beck y Daiss, Thurston Morton, and Ray Kent. December 6, 2011.

Paraquat Dichloride: Review of Human Ingestion Incidents. Evans, Elizabeth. May 21, 2014.

Paraquat Dichloride: Review of Human Incidents. Khin Swe Oo. December 12, 2011.

Paraquat: Potential Impacts of Proposed Mitigation . Jonathan Becker, Bill Chism, Sunil Ratnayake, and Derek Berwald. March 2, 2016.23 

### 6. APPENDICES

A PPENDIX A. P ARAQUAT D ICHLORIDE I NGESTION R ISK M ESSAGE FOR P ESTICIDE A PPLICATORS

.



### Paraquat Dichloride: One Sip Can Kill.

The Accidental Poisoning Problem The California Poison Control System and the Central California Children’s Hospital reviewed
data from 1998

- 2009 and identified more than 1,400 cases of accidental poisonings caused by storage of non

- food substanc es in soda bottles, unmarked bottles, cups or glasses. Several of the deaths involved the accidental ingestion of pesticides, including paraquat. 15

Recent Deaths from the Accidental Ingestion of Paraquat The California Poison Control System and the American Association of Poison Control Centers (AAPCC) recently sent letters of concern to EPA regarding a series of deaths from accidental ingestion of the pesticide paraquat in the San Joaquin Valley of Califo rnia. AAPCC cited 50 deaths from paraquat; at least 12 were from accidental ingestion of paraquat from a beverage
container.

This is a major concern to EPA because paraquat is a Restricted Use Pesticide that should not be accessible to the general public and, as with all pesticides, should never be placed into a beverage container. Paraquat is highly toxic to humans; one small accidental sip can be fatal and
there is no antidote.

The product labels clearly prohibit pouring paraquat into food or beverage containers with the prominently

- placed statements “NEVER PUT INTO FOOD, DRINK OR OTHER
CONTAINERS” and “DO NOT REMOVE CONTENT S EXCEPT FOR IMMEDIATE USE.”

Paraquat Use Profile Paraquat dichloride, commonly referred to as “paraquat,” is an herbicide registered in the United States since 1964 to control weeds in many agricultural and non

- agricultural use sites. It is also appl ied as a pre

- harvest desiccant on some crops including cotton.

All paraquat products registered for use in the United States are Restricted Use Pesticides (RUPs), which can only be sold to and used by certified applicators (and applicators under their

15 Epidemiology of Accidental Poisoning Caused by Storage of Non

- Food Substances in Food Containers and unmarked Bottles/Containers. Geller RJ, Kezirian R, Bangar P, Strong D, Carlson T. Children’s Hospital Central California; California Poison Control System (CPCS). Found online at: http://informahealthcare.com/doi/pdf/10.1080/1556365090307692424 d irect supervision). There are no homeowner uses and no products registered for application in
residential areas.

EPA Incident Investigation The fatalities resulting from paraquat products transferred into beverage containers in California prompted EPA to investigate all reported cases. EPA conducted an investigation of all reports of fatal and high

- severity paraquat incidents. EPA identified 27 paraquat fatality reports to date in its Incident Data System (IDS). The IDS database contains all registrant submissions of adverse health effects from pesticide products, as required by federal law (FIFRA §6(a)(2)). More than 80% of all identified paraquat fatality cases reported to IDS were due to ingestion of the product.

At least e ight of these 27 deaths were due to the accidental ingestion of paraquat. All eight of
these accidental deaths involved transfer of paraquat into a beverage container

. Several of these cases have occurred recently. A review of the SENSOR

- Pesticides data identified additional ingestion cases, including the fatal case of an 8

- year

- old child who drank the paraquat out of a
soda bottle.

True Stories

In 2013, a 70

- year

- old female ingested some contents of a re

- used iced tea bottle that contained paraquat, unknown to her. She went to the hospital awake and alert with persistent vomiting. Over the course of a 16

- day admission, she evolved the classic picture of paraquat ingestion: corrosive gastrointestinal injury plus kidney and respiratory failure leading to
death.

In 2010, a 44

- year

- old male mistakenly drank paraquat, which he thought was fruit juice. He developed difficulty breathing and vomited blood. He was admitted to the hospital intensive care unit where he died after 20 days of aggressive treatment.

In 2008, an 8

- year

- o ld boy drank paraquat that had been put in a Dr. Pepper bottle, which he found on a window sill in the garage. He died in the hospital 16 days later. His older brother had used the product on weeds around the house and put it in the bottle in the garage. The older brother obtained the product from a family friend who is a certified Restricted Use Pesticide applicator.

In 2003, a 49

- year

- old male took a sip from his coffee cup in which he had poured paraquat because the product’s bottle was deterioratin g. He realized his mistake and went to the Emergency Department. At that time, he was vomiting, cold and sweating profusely. Doses of activated charcoal were administered and his stomach was pumped; morphine was provided for esophageal pain; and he was intubated to support breathing function on the fourth day. Aggressive supportive care continued until he died on the tenth day.

In 2000, a 15

- month

- old boy ingested paraquat that had been transferred into a Gatorade container and stored inappropriately. The boy survived in the hospital for 13 days after the ingestion and received aggressive treatment but died after suffering acute kidney and liver
failure.

In 2000, an 18

- month

- old boy ingested an unknown amount of paraquat solution from a
bottle found i n his father’s landscaping truck. He received multiple

- dose activated charcoal treatment two hours after the ingestion. He suffered from lack of oxygen during the first 24 hours followed by progressive liver, kidney, and cardio

- pulmonary dysfunction. Th e boy died 11 days after the ingestion.25 EPA Response While EPA determines the appropriate regulatory response, we want to warn the applicator community about the high toxicity of paraquat.

It is the responsibility of pesticide applicators to ensure that RUP products are used safely and appropriately, including never transferring any pesticide product, including paraquat, into a beverage container.

The Solution is YOU

ONE SIP CAN KILL!

T o prevent the severe injury and/or death from paraquat ingestion, a paraquat product must:

• Be used only by a certified applicator or under the direct supervision of a certified applicator;

• Never be transferred to a food, drink or any other container;

• A lways be kept secured to prevent access by children and/or other unauthorized persons;

• Never be stored in or around residential dwellings; and

• Never be used around home gardens, schools, recreational parks, golf courses or playgrounds.

Paraquat Dichloride Information Resources

• EPA’s Paraquat Dichloride Registration Review Docket, EPA

- HQ

- OPP

- 2011

- 0855, for
information on EPA’s current re

- evaluation of paraquat. This docket includes a letter from Dr. Gellar (California Poison Control System), the EPA respon se, and the AAPCC letter. http://www.regulations.gov/#!docketDetail;D=EPA

- HQ

- OPP

- 2011

- 0855

• Syngenta’s Paraquat Information Center: www.paraquat.com/safety26 A PPENDIX B. C ASE D ESCRIPTIONS OF 31 M ODERATE S EVERITY O CCUPATIONAL I NCIDENTS O CCURRING B ETWEEN 1998 AND 2012.

SENSOR

- Pesticides 1998

- 2011 Occupational Paraquat Cases of High/Moderate Severity

cexpid Year State Severity Equipment Site Health
Effects Case Description Prevention
Narrative

WA00318 2011 WA 3 09 02 He stopped spraying
because
of the pain of
his back.
He complaine
d at the hospital of itching
and
irritation at night.
The MD He applied glyphosate from August 8th to August 9th. He applied the paraquat from August
10th to the
12th. His back pack had a leak
and he was getting his back
wet while spraying. He thought it was just sweat. He
did not wash until getting
home. The back pack

sprayer was in disrepair. It
had a leak
and his
back was with the spray. He
did not
wash at the
ranch. He would get
home and
tak e a shower
after work.
He did not

wear an
apron or chemical
resistant
suit as
indicted in
the label
of
Gramo xone WA00351 2011 WA 3 11 01 He had a tank
in a tractor. He was burning
weeds. He went
to put another
tank & the
nozzles clog ged. He moved it up, gave it pressure, then it exploded. Sprayed in his eyes. There
was a hose
about 30 ft away. Where
he rinsed out his eye. The hose clogged. It
was 4

- 6 months old,
he doesn't
know who
used it prior. It

was corroded. The safety glasses

were insufficient
but it was
too hot to
wear all protective27 equipment. they fog.

NC04257 2011 NC 3 99 01 Farmworker working on a farm got
paraquat dichloride on
his feet and developed
burns. Farm
worker working on a farm got
paraquat dichloride
on his feet
and developed
burns.

FL03996 2010 FL 3 99 99 gramoxone inteon was splashed on the face of 28 year
old male patient at work.
He works with the product regularly.

NC02597 2010 NC 3 99 01 Meds
received.
Could not

contact despite multiple
attempts. Offered

resources to wife
and sent
letter. Farmer spraying gramoxone in
field and believes he got
the mist in his

eyes. Man got
Gramoxone in eyes on
his farm.

CA18227 2010 CA 3 11 01 Spraying gramoxone and was exposed
when it leaked
into the cab of
the tractor

WA03025 2009 WA 3 11 01 A 30 y/o male spraying an
herbicide in a vineyard had
ocular and
dermal exposure when
he was accidentally sprayed He was wearing safety glasses, not goggles or
face shield. However,
the label did require protective

eye wear but was not specific as28 to type. According
to L&I he
did not
decontamin

ate properly and likely
rubbed his

eyes. WA02659 2007 WA 3 11 01 A 27 y/o farm
worker arrived
at the E.R. complaining of cardiovascular, neurological
and G.I.
symptoms.
LA02842 2007 LA 3 12 99 erythema, hives,
burns spilled (gramoxone)
on foot Monday while at work; went

to MD Thursday

LA02664 2007 LA 3 99 01 chest pain (non cardiac), dyspnea, tachycardi

a sugar cane farmer applied (gramoxone inteon) last week, hose broke; had symptoms for
two weeks after

exposure CA14394 2005 CA 3 09 01 He was carrying

paraq ua t in a backpack
container for 6

- 10 hours and
some of the paraquat leaked
onto his back

LA02037 2005 LA 3 11 01 CO
dermal
and ocular irritation,
and erythema;
referred to LDAF;
txd at ER 8 days >

exp Exposed to
gramaxone at work when
hose burst during spraying.29 LA01063 2004 LA 3 99 01 CO dypsnea, headache,
chest pain,
blurred vision;

sores on tongue Spraying gramoxone and
diuron on peach plants @
work and some
blew back on him; referred to
LDAF According
to "label" variable,
violations
occurred.

L abel says
that pesticide
shouldn’t
make

contact with any

person OR01222 2004 OR 3 99 02 Symptom

s star ted following last day of work, Setting irrigation pipes for

one month
around

trees. N o mask was
used. Jose bought his own gloves & rubber suit, no
rubber boots.

WA01130 2003 WA 3 09 01 A 25 y/o male developed
neurol ogical, gastrointestinal
and oc ular
symptoms while spraying. Sought medical

treatment
LA00439 2003 LA 3 13 01 confused,

near syncopal ,
unable to
talk for

some minutes ER report states p atient was working
over tank of gramoxone &
vehicle
solvents and
wind cau sed
him to inhale strong fumes

CA13372 2003 CA 3 99 01 Working as a sprayer using
paraquat. Patient feels dizzy and chest
hurts. Doctor
states "no specific event

- patient questions30 cumulative injury"

NY00510 2001 NY 3 11 01 MD
suspects pest icide poisoning

- low
WBC's. 2 signs fungicide poisoning

- weight
loss &
anemia.
Reason
for low
cholineste

rase not determine
d. Farmer reports

oc casional
exposure to pesticides when ground spraying, due
to wind shift. Sole appl icator
for farm for 2

yrs.

TX01844 2000 TX 3 15 10 Case exposed
to paraquat (gramoxone)
when hand spray tank fell
over. Hands exposed.
Thumb nail
became
infected

CA07798 2000 CA 3 99 01 Patient exposed while spraying paraquat from a
tractor and wearing a
mask. He
exited behind the tractor, took
off his mask
and talked to a supervisor and was exposed
for 30 min. Developed chest pain, cough,
shortness of breath, and pleuritic chest pai n Patient

exp osed
while spraying
paraquat from a
tractor and wearing a
mask. He
exited
behind the
tractor, took off his
mask and
talked to a supervisor
and was exposed for
30 min. Developed chest pain, cough,
shortness of breath,31 and pleuritic chest pain.

CA04770 1999 CA 3 99 99 Spilled

gramoxone on boots, did not irrigate right

away FL00647 1999 FL 3 09 02 Patient has rash, blistering
on back from
exposure to backpack sprayer leaks.

CA05752 1999 CA 3 99 01 Exposed to
chemicals with possible
inhalation to paraquat and guthion. Developed cough,
shortness of breath, and pleuritic chest pain.

CA03860 1998 CA 3 99 01 Eye exposure to paraquat while spraying.

CA03776 1998 CA 3 10 01 Using paraquat while wearing gloves and gloves leaked. Developed
shortness of breath, hyperventilatio n, and a runny

nose.32 A PPENDIX C

. P ARAQUAT /D IQUAT /G LYPHOSATE /G LUFOSINATE I NCIDENT Q UERY M ETHODOLOGY

1. Query of SENSOR

- Pesticides case reports from 1998

- 2011

2. PC Codes query

a. Pc_code1 = 417300 or 103607 or 103605 or 103604 or 103608 or 103601 or

103603 or 128501 or 128850 or 032201 or 032202 or 016061 or 016063

b. Pc_code2 is null

c. This yields the total cases with a single active ingredient from above only

3. Intentional Exposures Removed: “Intnexpo does not = 1”

4. Includes only Application site (Appsite) = 01

a. Appsite 01 = Farm, all farms, orchard crop production excluding nursery,

livestock and forest

5. Results:

a. N= 228 cases total

b. (see “Single AI HerbicideCaseCompareAPPSITE1_becker.xlsx)

6. In the Excel output from Access, “Ch emical” column was added and populated with chemical name (diquat, glufosinate, glyphosate, paraquat) that corresponded to pc_code1

SENSOR

- Pesticides Query Results

Chemical Severity Total High Mod Low diquat 3 3 glufosinate 1 4 5 glyphosate 24 124 148
paraquat 1 19 52 72

Total 1 44 183 22833 A PPENDIX D

. S UPPLEMENTAL I NCIDENT R ATE T ABLES

Table B1 . Inciden t Rate for All
SENSOR

- Pesticide Cases

a.i. Incident rate per 100,000 pounds used Incident rate per 100,000 acres applied Incident rate per 1,000 respondents

Diquat 0.425 (0.137, 1.318) 0.139 (0.045, 0.430) 0.318 (0.103, 0.987)

Glufosinate 0.037 (0.015, 0.088) 0.017 (0.007, 0.040) 0.035 (0.015, 0.085)

Glyphosate 0.020 (0.017, 0.024) 0.017 (0.014, 0.020) 0.062 (0.053, 0.073)

Paraquat 0.270 (0.214, 0.340) 0.123 (0.098, 0.156) 0.332 (0.263, 0.418)

Table B2

. Comparisons of Incident Rate Ratio for All

SENSOR

- Pesticide Cases

per 100,000 pounds per 100,000 acres applied per 1,000 respondents

Comparison Incidence Rate Ratio (95% CI) P

- value Incidence Rate Ratio (95% CI) P

- value Incidence Rate Ratio (95% CI) P

- value

Paraquat vs. Diquat 0.634 (0.200, 2.013) 0.4400 0.891 (0.281, 2.828) 0.8450 1.042 (0.328, 3.306) 0.9447

Paraquat vs. Glufosinate 7.354 (2.971, 18.205) <.0001 7.469 (3.017, 18.490) <.0001 9.344 (3.775, 23.132) <.0001

Paraquat vs. Glyphosate 13.340 (10.066, 17.679) <.0001 7.273 (5.488, 9.639) <.0001 5.370 (4.052, 7.117) <.0001

Diquat vs. Glufosinate 11.592 (2.770, 48.506) 0.0008 8.381 (2.003, 35.071) 0.0036 8.970 (2.144, 37.535) 0.0027

Diquat vs. Glyphosate 21.027 (6.705, 65.945) <.0001 8.161 (2.602, 25.595) 0.0003 5.155 (1.644, 16.167) 0.0049

Glufosinate vs. Glyphosate 1.814 (0.744, 4.423) 0.1903 0.974 (0.399, 2.374) 0.9533 0.575 (0.236, 1.401) 0.2231

The results show that the incident rates of all cases including high, moderate, and low severity outcomes of paraquat and diquat were significantly higher than that of g lufosinate or g lyphosate in all three ways of normalizing by amount a.i. used (pounds), by number of treated acres, and by the number of respondents. For example, the incident rate of all cases including high, moderate, and low outcomes normalizing by amount a.i. used of paraqua t was estimating about 7.35 times of g lufosinate and 13.34 times of g lyphosate.34 A PPENDIX E

. P ROPOSED L ABEL A MENDMENTS

Proposed label amendments Location on label
DANGER/PELIGRO On First Page

POISON/ VENENO

CORROSIVE TO SKIN AND EYES / CORROSIVO A LA PIEL
Y A LOS OJOS
KEEP OUT OF REACH OF CHILDREN/MANTENER FUERA DEL ALCANCE DE LOS NIÑOS

READ ENTIRE LABEL PRIOR TO USING THIS PRODUCT / LEA TODA LA ETIQUETA ANTES DE UTILIZAR ESTE
PRODUCTO IN THE CASE OF AN ACCIDENT, SEEK IMMEDIATE
MEDICAL ATTENTION. SYMPTOMS ARE PROLO NGED, PAINFUL, AND CAN BE FATAL/ EN CASO DE ACCIDENTE, BUSQUE ATENCIÓN MÉDICA INMEDIATAMENTE.
Si usted no entiende la etiqueta, busque a alguien para que se la explique a usted en detalle”. (If you do not understand the label, find someone to explain it to you in detail). Danger

– Fatal If Swallowed Or Inhaled /LETAL SI SE INGIERE
O INHALA In Warning Box (or Area) within the first two

pages Causes Severe Eye Injury / CAUSA DAÑO SEVERO EN LOS

OJOS
Corrosive To Skin / CORROSIVO A LA PIEL

NEVER TRANSFER THIS PRODUCT INTO FOOD OR
BEVERAGE CONTAINERS OR CONTAINERS NOT
EXPLICITLY INTENDED FOR PESTICIDES /NUNCA
TRANSFEIERA ESTE PRODUCTO EN ALIMENTOS O
BEBIDAS EN RECIPIENTES O ENVASES NO
EXPRESAMENT PREVISTO PARA PESTICIDES Store Tightly Closed In Original Container, And In A Locked Place Away From Children And Animals / ALMACENE EN
CONTENDOR ORIGINAL COMPLETAMENTE CERRADO EN UN LUGAR CON LLAVE LEJOS DE NIÑOS Y/Ó

ANIMALES

Never Use this product In Residential Or Public Rec reational Settings (E.G. Homes, Home Gardens, Schools, Recreational Parks, Golf Courses, and/or Playgrounds) / NUNCA UTILICE ESTE PRODUCTO EN ÁREAS RESIDENCIALES Y/Ó LUGARES RECREACIONALES ABIERTOS AL PÚBLICO (E.G. Casas/Hogares, Jardines, Escuelas, Parques Recreacionales y/ó Infantiles y Campos de Golf) This product is toxic! An alerting agent (odor) has been added to help prevent accidental ingestion / Este producto es TÓXICO! Un agente de alerta (olor) se ha añadido para ayudar a evitar la ingestión accide ntal See Back Of Product Container For Important Safety
Information / Ver Detrás del Contendor del Producto para Información de Seguridad Importante35 A PPENDIX F

. S UMMARY OF P ROPOSED S UPPLEMENTAL W ARNING M ATERIALS

1. Mock

- up of sticker to be affixed to the cap of all paraquat dichloride product containers



## DANGER

– ONE SIP CAN KILL

PELIGRO

- UN SORBO PUEDE MATAR

2. Product Package Safety Requirements Sticker (PPSR) to be affixed to all paraquat dichoride product containers

Required Language Language Format
NEVER TRANSFER THIS PRODUCT
INTO FOOD OR BEVERAGE
CONTAINERS OR CONTAINERS NOT
EXPLICITLY INTENDED FOR
PESTICIDES English, Spanish, Pictogram

ONE SIP CAN KILL English, Spanish, Pictogram

CONTACT WITH SKIN MAY RESULT IN
POISONING English, Spanish, Pictogr am

EXPOSURE TO EYES MAY CAUSE
SUBSTANTIAL EYE INJURY English, Spanish, Pictogram

PARAQUAT SHOULD NEVER BE USED
IN RESIDENTIAL OR PUBLIC RECREATIONAL SETTINGS (E.G. HOMES, HOME GARDENS, SCHOOLS, RECREATIONAL PARKS, GOLF COURSES, AND/OR PLAYGROUNDS) Englis h, Spanish, Pictogram

PARAQUAT SHOULD ALWAYS BE
STORED TIGHTLY CLOSED IN ORIGINAL CONTAINER, AND IN A
LOCKED PLACE AWAY FROM
CHILDREN AND ANIMALS English, Spanish, Pictogram

READ ENTIRE LABEL PRIOR TO
OPENING THIS PRODUCT English, Spanish, Pictogram36 3. Paraquat Dichloride Safety Counter Card to be distributed with all paraquat dichloride products

Required Language Language Format
NEVER TRANSFER [PRODUCT NAME]
INTO FOOD OR BEVERAGE
CONTAINERS OR CONTAINERS NOT
EXPLICITLY INTENDED FOR [PRODUCT NAME] Engli sh, Spanish, Pictogram

ONE SIP CAN KILL English, Spanish, Pictogram

CONTACT WITH SKIN MAY RESULT IN
POISONING English, Spanish, Pictogram

EXPOSURE TO EYES MAY CAUSE
SUBSTANTIAL EYE INJURY English, Spanish, Pictogram

PARAQUAT SHOULD NEVER BE USED
IN RES IDENTIAL OR PUBLIC RECREATIONAL SETTINGS (E.G. HOMES, HOME GARDENS, SCHOOLS, RECREATIONAL PARKS, GOLF COURSES, AND/OR PLAYGROUNDS) English, Spanish, Pictogram

PARAQUAT SHOULD ALWAYS BE
STORED TIGHTLY CLOSED IN ORIGINAL CONTAINER, AND IN A
LOCKED PLACE AWAY FROM
CHILDREN AND ANIMALS English, Spanish, Pictogram

READ ENTIRE LABEL PRIOR TO
OPENING THIS PRODUCT English, Spanish, Pictogram

DISREGARDING LABEL DIRECTIONS IS
A VIOLATION OF FEDERAL LAW AND
IS PUNISHABLE BY SUCH English, Spanish