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pdfU.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF INSPECTOR GENERAL
Chemical Safety
Additional Measures Can
Be Taken to Prevent Deaths
and Serious Injuries From
Residential Fumigations
Report No. 17-P-0053
December 12, 2016
Report Contributors:
Jeffrey Harris
Jee W. Kim
Calvin Lin
Denton Stafford
Steven Weber
Abbreviations
EPA
FIFRA
FY
OCSPP
OECA
OIG
OPP
ppm
PRDA
Cover photo:
U.S. Environmental Protection Agency
Federal Insecticide, Fungicide, and Rodenticide Act
Fiscal Year
Office of Chemical Safety and Pollution Prevention
Office of Enforcement and Compliance Assurance
Office of Inspector General
Office of Pesticide Programs
parts-per-million
Puerto Rico Department of Agriculture
A residence in Florida is fumigated with sulfuryl fluoride to combat drywood
termites. (EPA OIG photo)
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U.S. Environmental Protection Agency
Office of Inspector General
17-P-0053
December 12, 2016
At a Glance
Why We Did This Review
The U.S. Environmental
Protection Agency’s (EPA’s)
Office of Inspector General
(OIG) conducted this review to
determine the extent and
nature of adverse impacts
caused by structural
fumigation. We also sought to
determine whether regulatory,
program execution (e.g.,
training, funding, inspections,
enforcement, etc.), or other
factors are associated with
adverse impacts.
The focus of our review was
sulfuryl fluoride, the primary
pesticide used in residential
fumigation, and one that is
highly toxic to humans.
Residential fumigation involves
filling a home with sulfuryl
fluoride and placing a tarp or
tent over the home to trap gas
inside. This review focused on
EPA Regions 2, 4 and 9, as
they oversee states that
conduct the most residential
fumigations.
This report addresses the
following EPA goals or
cross-agency strategies:
Ensuring the safety of
chemicals and preventing
pollution.
Protecting human health
and the environment by
enforcing laws and
assuring compliance.
Send all inquiries to our public
affairs office at (202) 566-2391
or visit www.epa.gov/oig.
Listing of OIG reports.
Additional Measures Can Be Taken to Prevent Deaths
and Serious Injuries From Residential Fumigations
What We Found
Since 2002, at least 11 deaths and two serious
injuries occurred during residential fumigations in
the two U.S. states with the most fumigation
treatments—California and Florida. Compliance
with current pesticide use requirements does not
always prevent adverse impacts.
The EPA can better prevent
deaths and serious injuries
caused during residential
fumigations by amending
sulfuryl fluoride labels and
monitoring compliance.
We identified multiple factors that contributed to these adverse impacts,
including: (1) no requirement to secure tenting around structures undergoing
fumigation, (2) ineffective devices used to detect pesticide levels inside of
structures, and (3) failure to attend mandatory training for residential pesticide
applicators who conduct fumigations.
In addition, we identified other program control risks that, if addressed, could
reduce the risk of future deaths and serious injuries:
The EPA could designate residential fumigation as a priority area for
enforcement, with special emphasis placed on locations such as Puerto
Rico, which has a high demand for residential fumigations but lacks
information to effectively oversee such fumigations. Data on sales and use
of sulfuryl fluoride in Puerto Rico are not reported and are unknown.
The EPA could require site-specific residential fumigation management
plans. Such plans can prevent accidents, identify appropriate emergency
procedures, and demonstrate compliance with requirements.
The EPA could complete work to develop a comprehensive national
pesticide incident database to monitor residential fumigation risks. The EPA
has an ongoing pesticide incident database initiative to collect data, but
there is no scheduled completion date.
Recommendations and Planned Agency Corrective Actions
We recommend that the EPA implement a process to evaluate label changes for
all three brands of sulfuryl fluoride to require secured tenting and fumigation
management plans, clearly define the criteria for meeting the applicator
stewardship training requirement, conduct an assessment of clearance devices
to validate their effectiveness, and establish milestone dates for the pesticide
incident database initiative. We also recommend that EPA Region 2 incorporate
into the cooperative agreement with the Puerto Rico Department of Agriculture,
an investigation and evaluation of sulfuryl fluoride usage to determine whether
misuse has occurred, and then the EPA should provide assistance to Puerto Rico
as needed. The agency provided acceptable corrective actions and milestone
dates for six of the seven recommendations. Six recommendations are resolved.
One recommendation is unresolved with resolution efforts in progress.
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
THE INSPECTOR GENERAL
December 12, 2016
MEMORANDUM
SUBJECT:
Additional Measures Can Be Taken to Prevent Deaths and Serious Injuries
From Residential Fumigations
Report No. 17-P-0053
FROM:
Arthur A. Elkins Jr.
TO:
Cynthia Giles, Assistant Administrator
Office of Enforcement and Compliance Assurance
Jim Jones, Assistant Administrator
Office of Chemical Safety and Pollution Prevention
Judith Enck, Regional Administrator
EPA Region 2
This is our report on the subject evaluation conducted by the Office of Inspector General (OIG) of the
U.S. Environmental Protection Agency (EPA). The project number for this evaluation was
OPE-FY16-0004. This report contains findings that describe the problems the OIG has identified and
corrective actions the OIG recommends. This report represents the opinion of the OIG and does not
necessarily represent the final EPA position. Final determinations on matters in this report will be made
by EPA managers in accordance with established audit resolution procedures.
The offices responsible for issues evaluated in this report are the Office of Pesticide Programs, within
the Office of Chemical Safety and Pollution Prevention; the Office of Compliance, within the Office of
Enforcement and Compliance Assurance; and EPA Region 2, which has primary responsibility for
issues pertaining to the Commonwealth of Puerto Rico.
Action Required
One OIG recommendation in this final report is unresolved. In accordance with EPA Manual 2750, we
are requesting a meeting of action officials from EPA Region 2 and the OIG’s Office of Program
Evaluation to start the resolution process. If resolution is not reached within 30 days of the date of the
report, agency action officials are required to complete and submit a dispute-resolution request to the
EPA’s Chief Financial Officer.
We will post this report to our website at www.epa.gov/oig.
Additional Measures Can Be Taken to Prevent Deaths
and Serious Injuries From Residential Fumigations
17-P-0053
Table of Contents
Chapters
1
2
Introduction ......................................................................................................
1
Purpose .....................................................................................................
Background................................................................................................
Responsible Offices ...................................................................................
Scope and Methodology ............................................................................
1
1
4
5
Factors Contributing to Human Deaths Associated With
Residential Fumigation Need to Be Addressed ..............................................
7
Extent of Adverse Impacts in California and Florida ...................................
Labels Lack Requirement to Secure Tenting and Deaths Result................
EPA Needs to Ensure the Efficacy of Clearance Devices ..........................
States and Territories Do Not Ensure That the Label Requirement
for Stewardship Training Is Met ............................................................
Residential Fumigation Is Not an Enforcement Priority Area ......................
EPA Does Not Require Residential Fumigation Management Plans ..........
Puerto Rico Lacks Information and Processes for Proper Oversight ..........
EPA Does Not Have a Comprehensive Database Available to
Track Potential Pesticide Poisoning ......................................................
Conclusion .................................................................................................
Recommendations .....................................................................................
Agency Response and OIG Evaluation ......................................................
7
9
9
14
15
15
16
Status of Recommendations and Potential Monetary Benefits .............................
17
10
11
12
13
Appendices
A
Agency Response to Draft Report and OIG Comments ................................
B
Distribution .......................................................................................................
18
26
Chapter 1
Introduction
Purpose
The U.S. Environmental Protection Agency’s (EPA’s) Office of Inspector
General (OIG) conducted this evaluation to determine the extent and nature of
adverse impacts caused by structural fumigants.1 We also sought to determine
whether regulatory, program execution (e.g., training, funding, inspections,
enforcement, etc.), or other factors are associated with adverse impacts.
Background
In 2015, there were two high profile incidents of serious and permanent injury to
two families in the United States due to improper residential fumigation practices:
In March 2015, a family vacationing on St. John in the U.S. Virgin Islands
fell ill after a suspected pesticide exposure. Methyl bromide was used to
fumigate the adjacent condominium where the family was staying, even
though the EPA had banned methyl bromide for residential structure use
in 1984.2
In August 2015, members of a family of five fell ill after the family home
in Palm City, Florida, was fumigated using sulfuryl fluoride.3 The family
returned to the home after it had been cleared for reentry after 2 days. The
Commissioner of Agriculture found that the pesticide applicators
committed violations including the company’s certified operator not
participating in a training program required for the chemical used in the
fumigation, and using defective clearance devices to confirm the air inside
the home was safe.4
In 2015, the EPA’s Office of the Administrator established an agencywide
workgroup to recommend actions that the EPA could take to help prevent a
In the course of the evaluation, the agency recommended that the term “structural fumigation” be replaced by
“residential fumigation.” For the purposes of this report, the term “residential fumigation” covers fumigations of
both residences and commercial buildings.
2
On March 29, 2016, Terminix International Company LP, and its U.S. Virgin Islands operation, Terminix
International USVI LLC, pleaded guilty to criminal charges for illegally applying fumigants containing methyl
bromide in multiple residential locations in the U.S. Virgin Islands, in violation of the Federal Insecticide,
Fungicide, and Rodenticide Act.
3
The Florida Department of Health concluded that sulfuryl fluoride exposure was the most likely cause of illness for
the three family members who received medical care.
4
In March 2016, the owner and an employee of the subcontracted company that fumigated the Palm City home
pleaded guilty to a charge of using the pesticide improperly.
1
17-P-0053
1
reoccurrence of methyl bromide misuse. Our report is not focused on methyl
bromide misuse.
Residential Fumigation
Residential fumigation is a pest control method that involves filling the airspace
within a residence with a toxic gas. A tarp, or tent, is used over the structure to trap
gas inside. The gas penetrates the cracks, crevices and pores in wood to eliminate
pests such as drywood termites and bed bugs. Sulfuryl fluoride is the primary
pesticide ingredient used as a residential fumigant, and is classified by the EPA as a
“Restricted Use Pesticide” due to its high toxicity to humans. The large majority of
residential fumigations in the United States are performed in southern Florida,
southern California, Hawaii, Puerto Rico and the U.S. Virgin Islands. There are
close to 200,000 residential fumigations performed annually in California and
Florida.
Residential Fumigation Process
The residential fumigation process includes three phases: pre-fumigation,
fumigation and post-fumigation (Table 1). The pre-fumigation phase occurs on
the day of the residential fumigation, and involves prepping the home for
fumigation. The pest control crew covers the
structure with a series of tarps, with seams rolled
together and held in place with clamps to provide
a seal sufficient to retain fumigant inside the
“tent.”
Before the pesticide may be released into a home,
the certified operator performs a final walkFumigation of a home in California.
through to ensure that all preparations for
(EPA OIG photo)
residential fumigation requirements are met as
directed by the label. Requirements directed by the label include, but are not
limited to, ensuring that no human or animal life is within the fumigation zone;
doors, windows and all entrances are properly secured; air conditioning and heating
units are off; secondary locks are in place; and proper warning signs are posted.
Table 1: Residential fumigation process
Fumigation phase
Pre-Fumigation
Fumigation
Post-Fumigation
Description
A fumigation tent is set up and secured, and a walk-through of the
interior and exterior of the home is performed to ensure
compliance with label requirements.
The fumigant is administered, and the home is secured and
remains secured for the duration of the fumigation.
The tent is dismantled, the home is aerated and, eventually,
cleared for occupancy.
Source: The Florida Department of Agriculture and Consumer Services, OIG.
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2
Once the pre-fumigation requirements are met, a warning agent
(chloropicrin) is released within the home, because the pesticide
used for fumigation, sulfuryl fluoride, is an odorless gas.
Chloropicrin causes eye, nose, throat and upper respiratory
irritation, prompting an individual to leave the home. After the
release of the warning agent, the pesticide is released into the
residence. Certified operators are the only individuals authorized
to administer the pesticide.
Chloropicrin in a pan.
(EPA OIG photo)
The home remains secured for approximately 18 to 24 hours.
After the residential fumigation period has elapsed, the pest control
business will remove the tent and begin the aeration of the home. The pest control
crews remove the tarps, leaving in place the secondary locks on exterior doors,
placing warning signs on doors and allowing the structure to aerate for the required
time.
The final step of the aeration process is to test the
air and ensure that the house is safe for reentry by
taking multiple readings and measurements
throughout the house. A residence is considered
“cleared” after the certified operator has verified
the pesticide has adequately dissipated. The
certified operator will post clearance notices at all
entry points and notify the resident that the home is
clear to reenter.
Clearance device. (EPA OIG photo)
Regulatory Inspections
Section 26 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
sets forth the conditions for state enforcement authority for pesticide use
violations.5 Currently, all states have primacy with the exception of Wyoming.
The EPA provides oversight to ensure the adequacy of the overall state program
and an equal level of protection of human health across the country.6 Anyone
applying pesticides (such as residential fumigants) must comply with federal and
state laws. In general, states have primary authority for compliance monitoring
and enforcing proper pesticide use. State inspections determine whether:
Residential fumigation crews used proper preparation techniques and
proper safety equipment, signs were posted at all entrances and on all
sides of the tent’s exterior, and secondary locks were used.
FIFRA defines “state” to include the District of Columbia and U.S. territories.
EPA issued two Federal Register notices governing how the agency oversees the states with respect to primacy and
rescission of primacy through the “FIFRA State Primacy Enforcement Responsibilities: Final Interpretive Rule,”
and “Procedures Governing the Rescission of State Primary Enforcement Responsibility for Pesticide Use
Violations.” Within the parameters of Sections 26 and 27 of FIFRA, the interpretive rule on primacy, and the rule on
the procedures governing rescission, the EPA may conduct compliance monitoring inspections and initiate
enforcement actions for pesticide use violations.
5
6
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3
The level of safety to the public while the residential fumigation was
occurring was adequate. For example, inspectors check to see that there
are no visible tears in the tenting.
The certified applicator aerated the residence properly and followed
proper clearance procedures, which include the use of properly
functioning and calibrated clearance devices.
The EPA’s Office of Chemical Safety and
Pollution Prevention (OCSPP), Office of
Pesticide Programs (OPP), requires extensive
scientific data on the potential health and
environmental effects of a pesticide before
granting a registration, which is a license to
market that product in the United States. The
EPA evaluates the data and ensures that the
label translates the results of those evaluations
Example of a sulfuryl fluoride product
into a set of conditions, directions and
label. (EPA OIG photo)
precautions that define who may use a
pesticide, as well as where, how, how much, and how often it may be used. The
overall intent of the label is to provide clear directions for effective product
performance while minimizing risks to human health and the environment.
Pesticide product labels provide critical information about how to safely and
legally handle and use pesticide products. The EPA’s Office of Enforcement and
Compliance Assurance (OECA) provides funds to states to support compliance
and enforcement activities, such as compliance assistance, compliance
monitoring, case development and enforcement.7
Responsible Offices
The EPA offices with primary responsibility for the issues discussed in this report
include:
OPP, within OCSPP.
The Office of Compliance, within OECA.
EPA Region 2, which has primary responsibility for issues pertaining to
the Commonwealth of Puerto Rico.
Unlike most other types of product labels, pesticide labels are legally enforceable, and all carry the statement: “It is
a violation of Federal law to use this product in a manner inconsistent with its labeling.” In other words, the label is
the law.
7
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4
Scope and Methodology
We conducted this performance audit in accordance with generally accepted
government auditing standards. Those standards require that we plan and perform
the audit to obtain sufficient, appropriate evidence to provide a reasonable basis
for our findings and conclusions based on our audit objectives. We believe that
the evidence obtained provides a reasonable basis for our findings and
conclusions based upon our audit objectives. We conducted this audit from
October 2015 to July 2016.
We reviewed relevant materials, including laws, regulations, procedures and
guidance, such as the Joint OPP/OECA fiscal year (FY) 2015–2017 FIFRA
Cooperative Agreement Guidance, the 2013 FIFRA Inspection Manual, and
FY 2016–2017 OCSPP and OECA National Program Manager Guidance
documents.
We selected three regional offices (EPA Regions 2, 4 and 9) as the focus of our
evaluation. These EPA regions were selected based on the high number of
residential fumigations conducted in their states. We judgmentally chose to
review states within those regions—specifically, the states of Florida and Georgia
in Region 4, California and Hawaii in Region 9, and the territory of Puerto Rico
in Region 2. We reviewed individual investigative residential fumigation incident
case files involving deaths and serious injuries in California from 2003 through
2014, and in Florida from 2002 through 2007 and 2014 through 2015. These two
states conduct the most residential fumigation treatments in the United States.
We interviewed OPP and OECA staff and managers at EPA headquarters, EPA
regional pesticide and enforcement managers, and regional project officers. We
interviewed state pesticide program managers and staff from state departments of
agriculture on the residential fumigation inspection and enforcement programs
within their respective states. We also observed residential fumigation inspections
that took place in Florida and California. We interviewed the Inspector General of
the Florida Department of Agriculture and Consumer Services about their
evaluation of the structural fumigation process in Florida.
An OIG project staff member attended the University of Florida’s School of
Structural Fumigation in November 2015 to gain technical knowledge—through
classroom instruction and field demonstrations—of the residential fumigation
process. Additionally, to gain the perspectives of industry and nongovernmental
organizations, we interviewed officials from Beyond Pesticides, the National Pest
Management Association, Douglas Products (manufacturer of Vikane) and
Spectros Instruments.
17-P-0053
5
We reviewed residential fumigation incident data from OPP’s Incident Data
System,8 the National Pesticide Information Center, the National Institute for
Occupational Safety and Health/Sentinel Event Notification System for
Occupational Risks, the California Pesticide Illness Query, the Florida Department
of Health, and the American Association of Poison Control Centers. We also spoke
to EPA representatives about the agency’s Pesticide Incidents Workgroup.
8
Per FIFRA Section 6(a)(2), pesticide registrants are required to report to the EPA information concerning
unreasonable adverse effects on the environment caused by their products.
17-P-0053
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Chapter 2
Factors Contributing to Human Deaths Associated
With Residential Fumigation Need to Be Addressed
Since 2002, at least 11 deaths and two serious injuries9 occurred during residential
fumigations in California and Florida. We identified multiple factors that
contributed to the adverse impacts, including:
No requirement to secure or prevent access to tenting around homes
undergoing fumigation.
Ineffective devices used to detect pesticide levels inside of structures.
Failure to attend mandatory training for applicators conducting residential
fumigations.
We also found that there is no comprehensive national pesticide incident database
that the EPA could use to monitor residential fumigation-related risks. The EPA
has an ongoing pesticide incident database initiative to collect these data, but has
no scheduled completion date. Further, Puerto Rico, a high-volume fumigation
territory, lacks information to effectively oversee residential fumigations.
Extent of Adverse Impacts in California and Florida
To gain an understanding about the extent of adverse impacts caused by
residential fumigation, we reviewed pesticide incident follow-up reports involving
death and serious injuries from the two states with the most residential fumigation
treatments in the United States. We found that in California, between 2005 and
2014, there were at least seven deaths and one serious injury. In Florida, in
2002,10 there were two deaths, and between 2012 and 2015 there were two deaths
and one serious injury.
Our review of incident reports for the 11 fatalities revealed that one death was
reported as an alleged burglary that occurred after the introduction of sulfuryl
fluoride but prior to clearance. One death was reportedly caused by a pesticide
applicator’s negligence, because the applicator did not fully clear all persons out
of an apartment prior to fumigation. Two deaths were ruled as suicides. For the
remaining seven deaths, the incident reports did not contain a definitive reason as
to why the people entered homes after the introduction of sulfuryl fluoride but
prior to clearance.
We define “serious injury” as patients exhibiting signs or symptoms as a result of exposures that were life
threatening or resulted in significant residual disability or disfigurement.
10
A separate review of the Florida Department of Agriculture Bureau Chief’s personal fumigation incident datasheet
showed two fatalities due to residential fumigation exposure in 2002.
9
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Review of the two instances of serious injury revealed that one instance involved
injuries to an alleged burglar, with the injuries occurring after the introduction of
sulfuryl fluoride to a home but prior to clearance. The other instance of injury
occurred due to improper clearance by applicators, who used defective clearance
devices; the applicators also lacked required training.
Table 2: Analysis of incident reports from California and Florida (exposure to sulfuryl fluoride)
State
CA
Date
3/7/2005
Incident
Death
CA
6/2/2007
Serious
Injury
CA
12/19/2008
Death
CA
6/11/2010
Death
CA
1/17/2011
Death
CA
11/24/2011
Death
CA
4/22/2014
Death
CA
12/29/2014
Death
FL
1/9/2002
Death
FL
10/10/2002
Death
FL
12/17/2014
Death
FL
1/16/2015
Death
FL
8/16/2015
Serious
Injury
Summary
Pest control operators heard someone calling for help and
attempting to exit the tarped structure. The crew pulled a woman
out from under the tarps and contacted 911. The woman was
transported to the hospital, where she died. The fumigation
company was found to not have cleared all persons before
fumigating.
When the pest control operator returned to aerate a house
fumigated 3 days earlier, the operator found a man asleep on the
couch; he had broken into and ransacked the house.
Pest control operator found a tarp seam and back door open and a
woman inside a fumigated home. Police took custody of the
woman, but she collapsed and was pronounced dead soon after
arriving at a hospital.
A man was found dead on a carport sofa one day after fumigation.
The deceased (who had Alzheimer's disease) was last seen near
a treatment site, which was also his residence.
A man was found dead in the fumigated home. The police report
indicated the man was a tenant at a nearby sober living center
who attempted earlier to enter the center drunk and after curfew.
A man collapsed and died after a suspected burglary of a
fumigated home (several large tears on the tarp and a broken
window indicated an illegal entry to the home).
When a pest control operator arrived to begin aeration on a
fumigated home, he found a deceased man on the patio under the
fumigation tarp. The man was not a resident of the home.
When a pest control operator was checking the pesticide levels to
certify the house for reentry, a man’s body was found in a
bathroom. The victim may have formerly lived at the residence;
however, the property owner told police the home was vacant at
the time of fumigation.
A tenant was found dead in the fumigated apartment complex. The
authorities concluded the man committed suicide.
A tenant purposefully evaded detection during the final fumigation
inspection walk-through. The tenant left a suicide note.
A woman was found ill in an alley after entering a fumigated home.
She was taken to a hospital, where she died.
A fumigator found the body of a deceased woman who used a
chair to enter the fumigated house through a window.
A family of five was exposed to sulfuryl fluoride after entering their
recently fumigated home that was cleared for re-occupancy. The
pest control operator did not have working clearance devices, and
had not attended mandatory stewardship training.
Sources: California Department of Pesticide Regulation, and Florida Department of Agriculture and Consumer
Services.
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Labels Lack Requirement to Secure Tenting and Deaths Result
Over 70 percent (eight of 11) of the deaths detailed in Table 2 occurred when
people entered unsecured tenting during the fumigation process. Only one of the
deaths occurred as a result of a label or state law violation on the part of the
pesticide applicators. Currently, sulfuryl fluoride labels do not require applicators
to secure fumigation tents. There are label requirements for securing homes with
secondary locks, posting warning signs, and using a warning agent. However,
these requirements have not prevented deaths at fumigated homes and businesses.
In terms of securing tents, the labels only require that the
seams be sealed (most often by using clamps), and that
sand and soil weights be used for the lower seams.
Example of warning sign and secondary
lock with a door handle removed to
prevent entry. (EPA OIG photo)
Fumigation tenting held together with
clips. (EPA OIG photo)
A Florida bureau chief said that secondary locks have
generally eliminated issues with tenants reentering
fumigated structures for one reason or another
(e.g., forgotten items, etc.). An industry representative
stated that the larger problem with early reentry is with
criminal behavior, including attempted burglary.
Opening the tenting (either by unclipping seams, moving
sand and soil weights, or tearing) and entering a fumigated
structure have resulted in eight deaths since 2002, and only
one of the deaths was due to an attempted burglary.
Regardless of the motives for entry into fumigated homes,
human deaths occur from entering unsecured tents.
According to the University of Florida Fumigation
Manual,11 an average of two deaths per year occur in the
United States as a result of illegal entry or incomplete
evacuation.
EPA Needs to Ensure the Efficacy of Clearance Devices
Before a resident can safely return home, the home must be cleared of the
fumigant. Sulfuryl fluoride labels require that calibrated clearance devices be used
for readings throughout the structure to ensure that any residual fumigant is within
acceptable levels for occupancy. The ability to detect residual sulfuryl fluoride
accurately is a critical phase of the fumigation process.
Currently, the concentration of sulfuryl fluoride must be under the level of 1 partper-million (ppm) to be considered safe for persons to reenter.12 Sulfuryl fluoride
labels require that an “approved” clearance device be used. OPP staff stated that
they are not responsible for reviewing or approving clearance devices, and did not
11
Rudolf H. Scheffrahn, Brian J. Cabrera and William H. Kern, Jr., University of Florida, Fort Lauderdale Research
and Education Center. 2005 Florida Fumigation Manual.
12
Since the 1980s, the EPA has modified the threshold clearance twice, from 10 ppm to 5 ppm, and then to 1 ppm.
17-P-0053
9
know who was. The EPA lacks assurance that devices currently marketed and in
use as residential fumigation clearance devices are effective for determining
whether fumigant concentrations are at the mandated safe level for reentry.
In the 2015 Palm City, Florida, fumigation exposure incident, the investigation
discovered that the applicators’ clearance devices were not retrofitted to the
current reading requirement of 1 ppm. The clearance devices were also defective
and had not been calibrated. As a result, family members were allowed to enter
their home prematurely, which resulted in serious harm to a family member.
OPP staff stated that they do not conduct independent testing of devices, and they
do not currently collect or review efficacy data from manufacturers. OPP staff
stated that their office relies on self-regulation by the device industry. The
selection of clearance devices is left up to registrants. Registrants propose
language for the label, and the EPA reviews and approves.
In October 1997, while the concentration level for safe reentry for sulfuryl
fluoride was still at the 5 ppm clearance level, OPP conducted a review of an
industry study of two designated clearance devices that had been specified on the
fumigant label. That review resulted in OPP requiring calibration within a month
prior to use of a device that had been used since the 1980s.13 The calibration
requirement was added to the label in 2003, and it is still a current requirement.
OPP is not aware of any similar review of these devices since the clearance
threshold for safe reentry was reduced to 1 ppm in 2004.
States and Territories Do Not Ensure That the Label Requirement for
Stewardship Training Is Met
The use of sulfuryl fluoride for residential fumigation can result in deadly or
significant health consequences if the chemical is not used in accordance with
safety requirements on label instructions, and operators are not properly trained.
Sulfuryl fluoride labels include requirements, such as, “application personnel
must participate in [manufacturer] Sulfuryl Fluoride Training and Stewardship
Plan/Program.”
Even though the labels require stewardship training before an operator can
purchase and use sulfuryl fluoride, we found that untrained operators could and
did purchase sulfuryl fluoride. The state pesticide agencies we contacted in
California, Florida, Georgia and Hawaii did not have controls in place to inspect
for and ensure that required training was completed.
In the 2015 Palm City, Florida, incident, the applicators had not taken the required
stewardship training. EPA inspections for methyl bromide misuse in the
13
The testing revealed that after approximately 28 days, the device differed from calibration gases by as much as 80
percent.
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Caribbean following the U.S. Virgin Islands incident showed that a fumigator
illegally used methyl bromide for residential purposes 41 times in Puerto Rico.
This particular fumigator had not been trained in the use of the fumigant as
required.
We found that the training requirement for sulfuryl fluoride is not being tracked
or verified in the states included in our review. Representatives from the pesticide
agencies we spoke to in California and Georgia stated that they were not
responsible for ensuring that the certified applicator attended stewardship training.
The representatives believed that it was the responsibility of the dealer to verify
that the operator had all the credentials to purchase and use sulfuryl fluoride. We
verified with OECA’s Office of Civil Enforcement that
stewardship training compliance is mandatory. According to
OECA, any condition on the label is required for legal use of that
product. As a result, failure to comply with that provision would
be considered a violation of FIFRA Section 12(a)(2)(G), which
states that it is “unlawful for any person to use any registered
pesticide in a manner inconsistent with its labeling.”
Cover of Florida Department of
Agriculture and Consumer
Services’ OIG’s January 2016
report.
The Florida Department of Agriculture and Consumer Services’
OIG stated in its January 2016 report14 that controls need to be
developed regarding stewardship training. The report
recommended specifying the frequency of stewardship training,
and requiring proof of training completion prior to licensing
fumigators. The 2016 report found that the state division
responsible for overseeing fumigations does not require
completion of a stewardship program for pesticide applicators to
obtain a license.
Residential Fumigation Is Not an Enforcement Priority Area
Residential fumigation is not an enforcement priority area for the EPA. The Joint
OPP/OECA Cooperative Agreement Guidance for FYs 2011 through 2013
instructed states to place emphasis on structural pest control misuse
investigations. Our discussions with EPA staff in Regions 2, 4 and 9 revealed that
regional staff recalled that soil fumigations were the priority rather than
residential fumigations. According to regional staff, residential fumigation is not
currently a priority area of focus in the cooperative agreement between EPA
regions and relevant states and territories.
An increase in oversight occurs when an issue area is designated as “required”
(i.e., an area of particular importance at a national level) or “pick list” (i.e.,
programs that support OPP and OECA goals) in the Cooperative Agreement
Guidance between EPA regions and states and territories.
Florida Department of Agriculture and Consumer Services’ OIG, Review of the Division of Agricultural
Environmental Services: Structural Fumigation Regulations and Processes. January 2016.
14
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EPA Does Not Require Residential Fumigation Management Plans
Soil and commodity fumigant15 labels require users to prepare a site-specific
fumigation management plan before the application begins. This includes the
documentation and retention of key information regarding each fumigation.
However, there is no current EPA requirement to have a residential fumigation
management plan. The agency justifies management plans for soil fumigants
based in part on the best practice of related industries’ use of health and safety
plans. In its re-registration document for a soil fumigant, the agency stated:
Information from various sources shows that health and safety
plans, fumigation management plans in this context, typically
reduce workplace injuries and accidents by prescribing a series of
operational requirements and criteria. In fact plans like these are
widely implemented in a variety of industries and are
recommended as standard approaches for occupational health and
safety management by groups such as American Industrial
Hygiene Association (i.e., through “Administrative” and
“Workplace” controls).
Management plans ensure thorough planning, prevent accidents, identify
appropriate emergency procedures, and demonstrate compliance with label
requirements. Soil and commodity fumigators must prepare a written, site-specific
plan before fumigation begins, and a certified applicator supervising the
application must verify that the plan is accurate.
In the absence of an EPA requirement for a residential fumigation management
plan, the state of California has taken action. California uses a standard
fumigation log to annotate property description, key dates during the fumigation
process, trade name and amount of fumigant used, amount of warning agent used,
and the trade name of the clearance device used, among other matters.
The EPA is currently re-evaluating16 structural fumigants. The intent of the EPA’s
re-evaluation is to add the fumigation management plan requirement to all
fumigants (including residential fumigants) going through the re-evaluation
process. The National Pest Management Association is working to develop an
industrywide standard for the EPA’s consideration. OPP expects to publish for
comment the re-evaluation results during 2018.
15
Soil fumigants are pesticides that, when applied to soil, form a gas to control pests that live in the soil and can
disrupt plant growth and crop production. Commodity fumigation uses chemical, gas or other treatment to eliminate
pests within the commodities and/or structures and containers normally used to contain them. The term “commodity”
refers to an economic product (i.e., of agricultural or mining) that is shipped from one place to another.
16
The EPA periodically reviews existing registered pesticides to ensure that they can be used safely and without
unreasonable risks to human health and the environment. The registration review program is intended to make sure
that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to
meet the statutory standard of no unreasonable adverse effects.
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Puerto Rico Lacks Information and Processes for Proper Oversight
The Puerto Rico Department of Agriculture (PRDA) needs better information and
processes to conduct oversight of residential fumigation activity within the
Commonwealth of Puerto Rico. The EPA’s investigation of the 2015 U.S. Virgin
Islands incident showed widespread misuse of methyl bromide in Puerto Rico, as
well as the U.S. Virgin Islands.
Methyl bromide is a restricted use pesticide that can be used only in very limited
situations, mainly for fumigation of soil and commodities. Methyl bromide is not
authorized for use in residential dwellings under any circumstances, and has been
banned for occupied structural use since 1984. The EPA’s investigation found that
fumigators in Puerto Rico used methyl bromide as a residential fumigant, and
identified hundreds of cases of illegal structural use. These instances included
fumigation of multiple residences, a school and a nursing home.
In light of the misuse of methyl bromide in Puerto Rico, we requested information
from PRDA regarding residential fumigation and the use of sulfuryl fluoride on
the island. PRDA was not able to provide adequate responses to OIG requests for
information. PRDA could not provide annual residential fumigation totals, the
annual amount of sulfuryl fluoride sold, or the annual number of PRDA
residential fumigation inspections performed. PRDA stated that they do not have
a fumigation notification requirement; therefore, they do not know when
residential fumigations take place.
While FIFRA and its implementing regulations do not require State Lead
Agencies to track the size of the industry, volume of fumigants sold, the number
of fumigation inspections conducted, or have a fumigation notification
requirement, the lack of information prevents PRDA from having the opportunity
to inspect fumigations as they are in process, and detect and enforce violations
where they occur. We believe this impedes deterrence from illegal or unsafe
residential fumigation activity on Puerto Rico.
California, Florida and Georgia advised that notification in advance of planned
residential fumigations (while not required by FIFRA and its implementing
regulations) was a key component in their oversight. The advance notification
provided these states the opportunity to observe all aspects of the residential
fumigation process as it occurs. According to these states, the likelihood of an
inspection or surveillance activity provides a significant deterrent from failure to
follow proper procedures.17
EPA Region 2 currently conducts numerous activities in Puerto Rico to ensure
that methyl bromide is used properly. Region 2 informed us that after its work
with methyl bromide is completed, it will work with PRDA to identify the
17
These states have chosen to implement regulations that are more stringent or broader in scope than the federal
requirements by requiring a fumigation notification requirement.
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fumigants (including sulfuryl fluoride) that were in common use for residential
and commercial establishments, evaluate whether misuse occurred, and develop
recommendations for regulatory changes that PRDA might implement to enhance
oversight and improve compliance.
EPA Does Not Have a Comprehensive Database Available to Track
Potential Pesticide Poisoning
There is no comprehensive database that maintains national pesticide incident data.
OPP receives pesticide incident data from a wide variety of sources, including:
Required reporting (from registrants under FIFRA Section 6(a)(2)).
Voluntary reports, from sources that include:
o National Pesticide Information Center.
o American Association of Poison Control Centers.
o National Institute for Occupational Safety and Health/Sentinel Event
Notification System for Occupational Risk.
o Canada’s Pest Management Regulatory Agency.
o State and local governments.
o Other federal agencies (e.g., the U.S. Fish and Wildlife Service, and
the National Oceanic and Atmospheric Administration).
o Other EPA offices (e.g., OECA) and EPA regions.
o The public (e.g., beekeepers).
While the above-listed sources provide stand-alone databases, they do not
interface with one another. Different sources collect different sorts of data and
information in different database formats. The EPA lacks a consolidated incident
database that allows the OPP to conduct oversight of incidents, analyze incident
trends, and make necessary recommendations to address identified issues.
The OPP Incidents Workgroup was established in 2014. The OPP workgroup
developed the framework and asked that a Pesticide Program Dialogue
Committee Workgroup be established to provide advice throughout the
development process. The Pesticide Program Dialogue Committee18 Incidents
Workgroup was formed in 2015 to help the EPA meet its long-term goal of
creating a publicly available framework for pesticide incident reporting. The
framework would improve the reporting, quality and efficient use of pesticide
incident data to ensure high-quality, science-based pesticide decisions. The
workgroup told the OIG that it plans to develop a central, publicly available
database for national pesticide incident data. However, at this time, the workgroup
has no timeline for accomplishing this task.
18
The Pesticide Program Dialogue Committee provides feedback to OPP on various pesticide regulatory, policy and
program implementation issues. The committee includes environmental and public interest groups, pesticide
manufacturers and trade associations, user and commodity groups, public health and academic institutions, and
federal and state agencies.
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Conclusion
Deaths and serious injuries occur during residential fumigations. Most fatal
incidents that we identified occurred because tented homes were vulnerable to
premature entry. Regardless of the motive of those seeking entry, fatalities
occurred. Other factors contributing to deaths and major illnesses from residential
fumigations we reviewed include a lack of training on the part of applicators, and
the use of outdated clearance devices. Working with industry and states, the EPA
can take steps to reduce the risk of death and severe injuries from residential
fumigations through amendments to existing sulfuryl fluoride labels, better and
more complete data on residential fumigation treatments, tracking the number of
and reasons for adverse events, and the increased attention and prioritization of
residential fumigation activity.
Recommendations
We recommend that the Assistant Administrator for Chemical Safety and
Pollution Prevention:
1. Implement a process to evaluate label changes for all three brands of
sulfuryl fluoride, including requirements to:
Create a barrier to access, use detection mechanisms, or require
similar measures designed to prevent access into fumigation tents.
Prepare a site-specific residential fumigation management plan
before application.
2. Provide label language that clearly defines the criteria for meeting the
applicator stewardship training requirement for sulfuryl fluoride, including
the frequency of training.
3. Conduct an assessment of clearance devices to validate their effectiveness
in detecting required clearance levels, as part of the Office of Pesticide
Programs’ ongoing re-evaluation of structural fumigants.
4. Establish milestone completion date(s) for the pesticide incident database
initiative.
We recommend that the Assistant Administrator for Enforcement and Compliance
Assurance:
5. Assess whether structural fumigation and fumigant product compliance
and associated applicator certification and training should be included
as focus areas in the FIFRA Cooperative Agreement Guidance, and
include them in the guidance as appropriate.
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We recommend that the Regional Administrator, Region 2:
6. Include in the FIFRA cooperative agreement with the Puerto Rico
Department of Agriculture, an investigation and evaluation of sulfuryl
fluoride usage to determine whether misuse has occurred.
7. Based on the Puerto Rico Department of Agriculture’s investigation and
evaluation, provide assistance to Puerto Rico to develop recommendations
for any appropriate changes to Puerto Rico regulations, such as requiring
the reporting of sales and use of sulfuryl fluoride, and require advance
notification of planned residential fumigations.
Agency Response and OIG Evaluation
The EPA generally agreed with six of the seven OIG recommendations. The
agency provided acceptable corrective actions and milestone dates for six of the
recommendations that are resolved. One recommendation is unresolved with
resolution efforts in progress. The agency’s complete response and OIG
comments are found in Appendix A.
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16
Status of Recommendations and
Potential Monetary Benefits
RECOMMENDATIONS
Rec.
No.
Page
No.
1
15
Subject
Implement a process to evaluate label changes for all three
brands of sulfuryl fluoride, including requirements to:
Planned
Completion
Date
Status1
Action Official
O
Assistant Administrator for
Chemical Safety and
Pollution Prevention
11/30/17
Create a barrier to access, use detection mechanisms, or
require similar measures designed to prevent access into
fumigation tents.
Potential
Monetary
Benefits
(in $000s)
Prepare a site-specific residential fumigation management
plan before application.
1
2
15
Provide label language that clearly defines the criteria for
meeting the applicator stewardship training requirement for
sulfuryl fluoride, including the frequency of training.
O
Assistant Administrator for
Chemical Safety and
Pollution Prevention
11/30/17
3
15
Conduct an assessment of clearance devices to validate their
effectiveness in detecting required clearance levels, as part of
the Office of Pesticide Programs’ ongoing re-evaluation of
structural fumigants.
O
Assistant Administrator for
Chemical Safety and
Pollution Prevention
11/30/17
4
15
Establish milestone completion date(s) for the pesticide incident
database initiative.
O
Assistant Administrator for
Chemical Safety and
Pollution Prevention
11/30/17
5
15
Assess whether structural fumigation and fumigant product
compliance and associated applicator certification and training
should be included as focus areas in the FIFRA Cooperative
Agreement Guidance, and include them in the guidance as
appropriate.
O
Assistant Administrator for
Enforcement and
Compliance Assurance
4/30/17
6
16
Include in the FIFRA cooperative agreement with the Puerto
Rico Department of Agriculture, an investigation and evaluation
of sulfuryl fluoride usage to determine whether misuse has
occurred.
U
Regional Administrator,
Region 2
7
16
Based on the Puerto Rico Department of Agriculture’s
investigation and evaluation, provide assistance to Puerto Rico
to develop recommendations for any appropriate changes to
Puerto Rico regulations, such as requiring the reporting of sales
and use of sulfuryl fluoride, and require advance notification of
planned residential fumigations.
O
Regional Administrator,
Region 2
9/30/17
O = Recommendation is open with agreed-to corrective actions pending.
C = Recommendation is closed with all agreed-to actions completed.
U = Recommendation is unresolved with resolution efforts in progress.
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Appendix A
Agency Response to Draft Report
and OIG Comments
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
[August 29, 2016]
OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
MEMORANDUM
SUBJECT:
Comments on the OIG Draft Report: “EPA Can Take Actions to Prevent Deaths
and Serious Injuries from Residential Fumigations.”
Project No. OPE-FY16-0004
FROM:
James J. Jones, Assistant Administrator
Office of Chemical Safety and Pollution Prevention
Cynthia Giles, Assistant Administrator
Office of Enforcement and Compliance Assurance
Judith Enck, Regional Administrator
Region 2
TO:
Arthur A. Elkins, Jr.
Inspector General
This memorandum is in response to the Office of Inspector General (OIG) Draft Report
entitled, “EPA Can Take Actions to Prevent Deaths and Serious Injuries from Residential
Fumigations.” The Office of Chemical Safety and Pollution Prevention (OCSPP), the Office of
Enforcement and Compliance Assurance (OECA), and Region 2 appreciate the OIG’s effort in
evaluating sulfuryl fluoride products. The EPA strongly agrees that protecting the public and the
environment from improper application of residential fumigants is critical, and will take action as
detailed below to address the OIG concerns and recommendations.
While the EPA agrees with the OIG on the importance of this issue, and will be taking
action in this area, the basic conclusion of the Draft Report as embodied in the title “EPA Can
Take Actions to Prevent Deaths and Serious Injuries from Residential Fumigations” is not
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supported by the documentation presented. The factors the Draft Report identifies as
contributing to the human deaths and serious injuries associated with residential fumigation are
misleading, and the related recommendations overstate the ability of the EPA to actually reduce
most of the deaths and serious injuries identified by the OIG. In particular, the data presented in
Chapter 2, Table 2, which presents deaths and serious injuries in California and Florida
associated with exposure to sulfuryl fluoride, demonstrate that factors such as home break-ins,
illegal trespass, and suicides play a significant role in the majority of deaths and serious injuries
identified by the OIG. It is unclear how label changes (even those potentially requiring enhanced
access barriers), revised applicator training requirements, or designating this issue as an EPA and
state pesticides program priority, could prevent or deter future efforts by individuals determined
to trespass or commit suicide. Mischaracterizing the adverse impacts associated with residential
fumigation, and the ability of the Agency to address those adverse impacts, could send an
alarming message to the public, as there are over 900,000 certified applicators nationwide that
make hundreds of thousands of applications annually. We therefore request that the OIG
reassess the underlying data for this report, and revise the narrative and titles accordingly. We
are available to discuss our response and the attached Technical Corrections with the OIG.
OIG Response: This assignment was conducted in accordance with generally accepted
government auditing standards. Those standards require that all findings, conclusions and
recommendations be supported. Regardless of motive for entry, we identified a vulnerability
in the current label language that allows for entry to occur. While it may be unclear whether
label changes will prevent future deaths, our recommendation is that this issue be seriously
considered. Otherwise, deaths will continue to occur. Understanding that the agency’s key role
with residential fumigation is tied to the ability to evaluate label language, we focused our
recommendations to reflect that role and ability. We edited the report title as follows:
“Additional Measures Can Be Taken to Prevent Deaths and Serious Injuries From Residential
Fumigations.”
I. Background and General Comments on the Report
The OIG Draft Report correctly states that Section 26 of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) sets forth the conditions for state enforcement
authority for pesticide use violations.19 Under this statutory framework, in general, states have
primary authority for compliance monitoring and enforcing proper pesticide use. The EPA
provides oversight to ensure the adequacy of the overall state program and an equal level of
protection of human health across the country. Accordingly, the application of pesticides (such
as fumigants in residential settings), requires compliance with both federal and state laws.
Currently, all states have primacy with the exception of Wyoming.
Because of this statutory framework, EPA’s enforcement authority is limited. As a result,
inspections by State Lead Agencies (SLAs) determine issues such as the following:
Whether a residential fumigation crew used proper preparation techniques and proper
safety equipment, if signs were appropriately posted at all entrances and on all sides of
the tent’s exterior, and whether secondary locks were used.
19
FIFRA defines “state” to include the District of Columbia and U.S. territories.
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Whether the level of safety to the public while a residential fumigation was occurring
was adequate. For example, inspectors check to see that there are no visible tears in the
tenting.
Whether a certified applicator aerated the residence properly and followed proper
clearance procedures, such as the use of properly functioning and calibrated clearance
devices.
To avoid misleading the public, and creating the misperception that the Agency could engage in
this type of activity in lieu of the states, the Report should note these types of limitations on
EPA’s actions due to the statutory framework under FIFRA. In addition, the recommendations
should be revised to reflect these statutory limitations on EPA activities.
OIG Response: We incorporated in the recommendations Region 2’s suggested changes
regarding their oversight authority.
The Draft Report makes several comparisons related to notification, tracking,
inspection, or reporting of sulfuryl fluoride fumigations that are implemented by some states.
The Report should more clearly explain that FIFRA does not require many of these activities,
and some states have chosen to implement regulations that are more stringent or broader in
scope than the federal requirements. If the intent of the OIG was to identify and highlight
some state best practices, and to encourage other states to implement such practices, the
Report should explicitly do so.
OIG Response: Footnote 16 details this information. We also added an additional footnote
(footnote 17).
The Agency is submitting its remaining additional comments as Technical
Corrections, in the form of a redline/strikeout mark-up of the Draft Report.
II. OCSPP’s Response to the Recommendations
The OCSPP generally agrees with the OIG’s recommendations.
Recommendation 1: Implement a process to evaluate label changes for all three brands of
sulfuryl fluoride, including requirements to:
Create a barrier to access, or use detection mechanisms, to prevent access into fumigation
tents.
Prepare site-specific residential fumigation management plans before application.
OCSPP Response and Proposed Corrective Action: Generally, the OCSPP considers a barrier
to be anything that restrains or prevents human access to the fumigation site, and creates this
condition on a temporary basis for the duration of the fumigation. The OCSPP will assess the
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viability of a number of options to revise current guidance and policy to evaluate label changes
for all three brands of sulfuryl fluoride, including but not limited to:
Evaluating the need for label changes for all three brands of sulfuryl fluoride.
Investigating the use of additional temporary fencing structures and other secondary
barriers to surround the area being fumigated for the specified period of time until
reentry is permissible.
Investigating the viability of the use of security personnel to protect the fumigation site,
to prevent members of the public from entering the site during treatment.
Re-assessing the need for additional guidance.
Incorporating public and stakeholder participation throughout the guidance revision
process.
Consider removing the provision in the Restricted Use Statement: “…or persons under
the Supervision of a Certified Applicator” thus requiring everyone that is involved in the
fumigation be Certified.
Timeframe: OCSPP will revise Agency guidance or policy with updated mitigation options
within one year of the OIG’s Final Report, by November 30, 2017. Within two years of the
Final Report, by November 30, 2018, OCSPP will begin implementing the revised guidance
(e.g., label changes and getting labels to the field).
OIG Response: We agree and consider this recommendation resolved and open with
corrective action pending.
OIG Recommendation 2: Provide label language that clearly defines the criteria for meeting
the applicator stewardship training requirement, including the frequency of training.
OCSPP Response and Proposed Corrective Action: OCSPP will reevaluate the label
language and guidance for meeting the applicator stewardship training requirement, including
the frequency of training for sulfuryl fluoride products used as residential fumigants.
Currently, EPA has a robust soil fumigant program which includes: requirements to develop
soil fumigant management plans, buffer zone safety requirements (with EPA calculators to
determine buffer zone areas), guidance on tarps and tarp usage, required soil fumigant
training, emergency preparedness and response requirements, as well as a Community
Outreach and Education on Soil Fumigants Program. OCSPP will use the experience gained
in the soil fumigant program to inform a solution for structural fumigation. EPA is also
actively finalizing the rule revisions to 40 CFR 171, Pesticide: Certification of Pesticide
Applicators. The revisions to 40 CFR 171 are a comprehensive regulatory update to the rule,
which when final, will provide a more robust regulation for non-soil fumigant applicators,
such as residential fumigant applicators.
In the interim, until the rule becomes final, and the new regulation is implemented, OSCPP
will:
Review existing policy and guidance for the soil fumigants program and applicator
certification and training program, to assess whether some existing policies and
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guidance can be modified and implemented to address label language that clearly
defines the criteria for meeting the applicator stewardship training requirement,
including the frequency of training.
Timeframe: Within one year of the final OIG report, by November 30, 2017, OCSPP will
create additional (interim) guidance language which clarifies the criteria for meeting the
applicator stewardship training requirement, including the frequency of training.
OIG Response: We agree and consider this recommendation resolved and open with
corrective action pending.
OIG Recommendation 3: Conduct an assessment of clearance devices to validate their
effectiveness in detecting required clearance levels, as part of the Office of Pesticide
Programs’ ongoing re-evaluation of structural fumigants.
OCSPP Response and Proposed Corrective Action: OCSPP will conduct an assessment of
clearance devices to validate their effectiveness in detecting required clearance levels, as part
of the Office of Pesticide Programs’ ongoing re-evaluation of structural fumigants. The
assessment may include:
Convening an agency workgroup with internal and external stakeholders to investigate
the current characteristics, including the instrumentation sensitivity, of clearance
devices.
An accounting of the clearance devices currently used.
An evaluation of the applicability and ease of use of devices currently on the market.
Reassessing the need to develop a method to ensure current clearance devices
available can detect concentrations of sulfuryl fluoride at the 1 ppm level.
Evaluating the need for additional guidance (other than the manufacturers’) for the
safe and proper use of clearance devices.
Timeframe: Within one year of the final OIG report, by November 30, 2017, OCSPP will
develop a strategy to assess the effectiveness of devices to detect required clearance levels.
Within two years of the final report, by November 30, 2018, OCSPP will validate and
implement new device clearance guidance.
OIG Response: We agree and consider this recommendation resolved and open with
corrective action pending.
OIG Recommendation 4: Establish milestone completion date(s) for the pesticide incident
database initiative.
OCSPP Response and Proposed Corrective Action: The OPP Pesticide Incident
Workgroup is in the process of developing detailed milestones for the pesticide incident
database initiative.
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Timeframe: Within one year of the final OIG report, by November 30, 2017, OCSPP will
provide a table of milestones and anticipated completion dates for the pesticide incident
database initiative.
OIG Response: We agree and consider this recommendation resolved and open with
corrective action pending.
III. OECA’s Response to the Recommendations
OECA recommends that Recommendation 5 be deleted and Recommendation 6 be revised as
described below.
OIG Recommendation 5: Develop a strategy to monitor compliance and enforcement of the
revised (based on Office of Inspector General recommendations) sulfuryl flouride labels.
OECA Response and Proposed Corrective Action: OECA takes a holistic approach in
developing compliance monitoring and enforcement strategies. Instead of focusing on
specific labeling requirements, of which there are many, OECA takes into consideration a
range of factors and focuses on identifying major program areas of interest where we believe
EPA and the states can have the most significant impact on human health and the
environment. The most effective mechanism for communicating the major program areas of
interest is the Cooperative Agreement Guidance (CAG). Accordingly, we recommend that
Recommendation 5 be deleted as the concept can be addressed via Recommendation 6 which
focuses on the CAG.
OIG Response: We deleted Recommendation 5 based on our review of the agency’s
reasoning for deletion.
OIG Recommendation 6: Designate structural fumigation as a focus area in the FIFRA CAG
for EPA regions with the highest frequency of residential fumigation treatments.
OECA Response and Proposed Corrective Action: We agree that structural fumigation is
an important issue. However, we believe that this issue should be expanded to include the
issues of fumigant product compliance and associated applicator certification and training in
order to effectively address public health and environmental concerns. In addition, we
believe that the efforts in this area should not be limited to just those regions and states with
the highest frequency of residential fumigations since structural fumigations can occur
throughout the United States. Therefore, we propose that the recommendation be revised as
follows:
”Assess whether structural fumigation and fumigant product compliance and
associated applicator certification and training should be included as focus areas in the
FY18-20 Cooperative Agreement Guidance (CAG), and include them in the CAG as
appropriate.”
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OECA will assess whether structural fumigation and fumigant product compliance and
associated applicator certification and training should be included as focus areas in the
FY 18-20 Cooperative Agreement Guidance (CAG), and will include them as appropriate.
Timeframe: Preliminary planning has begun for this document, and these areas of interest
have been part of the early discussions. This action will be completed with the issuance of
the FY 18-20 CAG by April 30, 2017.
OIG Response: We agree and consider this recommendation resolved and open with
corrective action pending.
IV. Region 2’s Response to the Recommendations
With respect to the two recommendations directed to Region 2, the Region is in
agreement that additional attention should be given to the evaluation of fumigants, including
sulfuryl fluoride. However, under FIFRA, the State Lead Agencies (SLAs) have primary
responsibility for the implementation of the pesticides program. As a result, EPA Region 2
cannot unilaterally implement some of the changes or additional evaluations noted by the
OIG. To implement the recommendations within its existing statutory authority, Region 2
will use its oversight authority to encourage states and territories to make short term and long
term regulatory changes and to better monitor sales, distribution, and use of fumigants within
their jurisdictions. Region 2 has already had detailed discussions with the state and territorial
pesticide agencies in its jurisdiction. EPA intends to send the OIG Report and
recommendations to all states and territories, to raise their awareness of and attention to the
issues of concern and best practices the OIG has identified.
OIG Recommendation 7: Investigate and evaluate sulfuryl fluoride usage in Puerto Rico and
determine whether misuse has occurred.
Region 2 Response and Proposed Corrective Action: In light of the comments above, Region
2 suggests the following revisions to the recommendation: “EPA will encourage the Puerto Rico
Department of Agriculture’s efforts to investigate and evaluate sulfuryl fluoride usage and
determine whether misuse has occurred.”
Region 2 will encourage and support the SLA’s efforts to investigate and evaluate sulfuryl
fluoride usage and determine whether misuse has occurred.
Timeframe: 3rd Quarter FY 2017.
OIG Response: This recommendation is unresolved. We edited the recommendation as
follows: “Include in the FIFRA cooperative agreement with the Puerto Rico Department of
Agriculture, an investigation and evaluation of sulfuryl fluoride usage to determine whether
misuse has occurred.”
OIG Recommendation 8: Based on Region 2’s investigation and evaluation, develop
recommendations for any appropriate changes to Puerto Rico regulations, such as requiring
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the reporting of sales and use of sulfuryl fluoride, and require advance notification of planned
residential fumigations.
Region 2 Response and Proposed Corrective Action: In light of the comments above, Region
2 suggests that the recommendation should be revised to “Based on SLA’s investigation and
EPA’s evaluation, EPA will assist SLAs to develop recommendations for any appropriate
changes to regulations, such as requiring the reporting of sales and use of sulfuryl fluoride, and
require advance notification of planned residential fumigations.”
Region 2 will encourage SLAs to develop recommendations for changes to regulations, such as
requiring the reporting of sales and use of sulfuryl fluoride, and require advance notification of
planned residential fumigations.
Timeframe: 4th Quarter FY 2017.
OIG Response: We edited the recommendation as follows: “Based on Puerto Rico
Department of Agriculture’s investigation and evaluation, provide assistance to Puerto Rico
to develop recommendations for any appropriate changes to Puerto Rico regulations, such as
requiring the reporting of sales and use of sulfuryl fluoride, and require advance notification
of planned residential fumigations.”
V. Conclusion and Contact Information
Overall, the Agency is pleased that the Draft Report identifies additional measures to
ensure the protection of human health and compliance with appropriate labels during the
residential fumigation process using sulfuryl fluoride products.
If you have any technical questions regarding these responses, please contact Rick
Keigwin, OCSPP/OPP, Keigwin.richard@epa.gov, or Elizabeth Vizard, OECA/OC at
Vizard.elizabeth@epa.gov. If you have other questions, please contact Janet Weiner, OCSPP’s
Audit Liaison, at Weiner.janet@epa.gov.
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Appendix B
Distribution
Office of the Administrator
Assistant Administrator for Enforcement and Compliance Assurance
Assistant Administrator for Chemical Safety and Pollution Prevention
Regional Administrator, Region 2
Agency Follow-Up Official (the CFO)
Agency Follow-Up Coordinator
General Counsel
Associate Administrator for Congressional and Intergovernmental Relations
Associate Administrator for Public Affairs
Principal Deputy Assistant Administrator, Office of Enforcement and Compliance Assurance
Deputy Assistant Administrator, Office of Chemical Safety and Pollution Prevention
Deputy Regional Administrator, Region 2
Director, Office of Compliance, Office of Enforcement and Compliance Assurance
Director, Office of Pesticide Programs, Office of Chemical Safety and Pollution Prevention
Audit Follow-Up Coordinator, Office of Enforcement and Compliance Assurance
Audit Follow-Up Coordinator, Office of Chemical Safety and Pollution Prevention
Audit Follow-Up Coordinator, Region 2
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File Type | application/pdf |
File Title | Additional Measures Can Be Taken to Prevent Deaths and Serious Injuries From Residential Fumigations |
Subject | pesticide, sulfuryl fluoride, methyl bromide, California, Florida, Puerto Rico, pesticide labels |
Author | US EPA, Office of Inspector General |
File Modified | 2016-12-09 |
File Created | 2016-12-09 |