Document ID: EPA-HQ-OPP-2006-0111-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-08-01T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

	WASHINGTON, D.C.  20460

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

	

April 10, 2007

MEMORANDUM

SUBJECT:	Review of Fenoxycarb Incident Reports

		DP Barcode D337388, Chemical #125301

FROM:	Monica Hawkins, M.P.H., Environmental Health Scientist

		Chemistry and Exposure Branch

		Health Effects Division (7509P)

		Hans Allender, Ph.D., Statistician

		Chemistry and Exposure Branch

		Health Effects Division (7509P)

THRU:	David J. Miller, Chief

		Chemistry and Exposure Branch 

		Health Effects Division (7509P)

TO:		Katherine Hall, Chemical Review Manager

		Special Review and Reregistration Division (7508P)

BACKGROUND

			

To generate this review, the Office of Pesticides (OPP) consulted the
following databases for the poisoning incidents on the active ingredient
Fenoxycarb. The purpose of the database searches is to identify
potential patterns of the extent and severity of the health effects
attributed to Fenoxycarb exposure. 

1)  Poison Control Centers – OPP purchases American Association of
Poison Control Center (AAPCC) data covering the years 1993 through 2005
for all reported pesticides incidents. The last acquisition of data
covering 2004 and 2005 took place in late 2006. Most of the national
Poison Control Centers (PCCs) participate in a national data collection
system, previously called The Toxic Exposure Surveillance System (TESS).
PCC reports includes 61 centers at hospital and universities that cover
100% of the United States population. Datasets incorporate an extensive
quality assurance process including a standardized computer-based data
collection. Some PCCs cover multiple States; others cover a metropolitan
area, or an entire State. PCCs provide telephone consultation for
individual consumers and health care providers on suspected poisonings,
involving drugs, household products, pesticides, etc.; data collection
to aid pesticide regulatory programs is secondary to this service. An
elaborate, computer assisted protocol is followed by specially trained
medical staff, and reports assess confirmed, possible, probable, or
definite pesticide exposures. Approximately 50% of base reports include
medical follow-up and clinical outcome are determined, e.g., cases
resolved by phone consultation with PCC specialist, patients seen in
health care facility, patients hospitalized, and patients admitted to
Intensive Care Unit (ICU) and in some cases death. PCCs receive calls 24
hours a day throughout the entire year, and they handle non-occupational
as well as occupational calls. Discussions are underway to improve
collection of OPP-specific occupational data. Because mainly consumers
initiate PCC calls, this database is not currently a complete source of
occupational poisoning incidents.

2)  OPP Incident Data System (IDS) This database includes reports of
incidents from various sources, including 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.  The IDS has been in existence since 1992. 
Reports submitted to the Incident Data System represent anecdotal
reports or allegations only, unless otherwise stated in this report. 
Typically, OPP does not draw conclusions implicating the pesticide as a
cause of any of the reported health effects.  Nevertheless, sometimes
with enough cases and/or documentation, patterns and risk mitigation
measures may be suggested.

3) National Institute of Occupational Safety and Health Sentinel Event
Notification System for Occupational Risks (NIOSH/SENSOR) performs
standardized surveillance in twelve states from 1998 through 2006. 
States included in this reporting system are Arizona, California,
Florida, Iowa, Louisiana, Michigan, North Carolina, New York, New
Mexico, Oregon, Texas, and Washington. A number of other States can and
do report, periodically and on request for special circumstances,
because they participate in the NIOSH/ SENSOR network as part of the
Council of State and Territorial Epidemiologists (CSTE).  Reporting is
variable from state-to-state because of the dissimilar cooperation from
different sources of reporting (e.g., workers compensation, Poison
Control Centers, emergency departments and hospitals, enforcement
investigations, private physicians, etc.).  Therefore, OPP does not
characterize these reports as estimating the total magnitude of
poisoning for a State.  The focus of OSHA/SENSOR database is on
occupationally related cases. However, the information collected on each
case is standardized and categorized according to the certainty of the
information collected and the severity of the case. Detailed exposure
circumstances may be available if the State provided follow-up case
reports, as in serious cases ending in death.

The purpose of this review is to summarize available pesticide poisoning
incident data for the active ingredient Fenoxycarb. This report contains
3 sections: 

1- Cases reported in the Poison Control Center Database from 1993 to
2005

2- Cases reported in the Incident Data System from 1999 to the present,
and

3- Cases reported in the NIOSH system from 1998 to 2003.

1.	  SEQ CHAPTER \h \r 1 Poison Control Center Data – 1993-2005

This section discusses results from the Poison Control Center’s Toxic
Exposure Surveillance System (TESS) from the years 1993 through 2005 and
reflects data stratified by population: occupational, non-occupational,
and children. The children class is five years of age or less; this
definition includes children about to become six years old, or up to 72
months old. Cases involving exposures to multiple products and cases
with unrelated medical outcome are excluded.  Also excluded are
intentional exposures, i.e., suicide attempts. The tables incorporated
in this section contain summaries of acute pesticide poisoning incidents
resulting from exposure to Fenoxycarb.

The following tables evaluate the frequency of poisoning incidents for
Fenoxycarb compared to the composite of all pesticides for which the PCC
received a non-excluded incident report.  The tables report the
frequency of events by health severity category (i.e.; all symptoms,
moderate, and major) and by level of health care received.  A
comparative ratio provides a simple measure of the relative frequency of
reported health effects by severity category.  Knowledge of the ratios
of symptoms for a single chemical (or a group of chemicals) provides a
relative measure of the public health impact of the acute pesticide
events.  In addition, a Likelihood Ratio test shows whether the compound
under study is significantly different from the average of all other
pesticides.  An (s) next to the ratio indicates the proportions are
significantly different.   

For a detailed explanation of the tables, see Attachment 2.

Table 1. Relative Frequency of Acute Pesticide Poisoning Incidents by
Symptom Severity: Occupational Cases 

	Severity of outcome

(outcome determined)	Total

exposed	Health care 

provided

Denominator numbers	14	16	10

Measures	SYM1	MOD2	MAJ3	HCF4	HOSP5	ICU6

Numerator numbers	14	2	0	10	0	0

Fenoxycarb percents	100.00%	14.29%	0.00%	62.50%	0.00%	0.00%

Average of all Pesticides 	86.25%	20.89%	0.81%	42.94%	7.00%	2.83%

Ratio of  Fenoxycarb

to average of all pesticides	1.16

P =0.13	0.68

P = 0.54	0.00

P = 0.73	1.46 

P = 0.11	0.00 

P = 0.38	0.00 

P =0.59

1) Percent of cases with ANY symptom in relation to the total of cases
followed; 2) Percent with moderate symptoms in relation to the total of
cases followed; 3) Percent with major or fatal outcome in relation to
the total of cases followed; 4) Percent of case seen in a Health Care
Facility (HCF) in relation to total exposures; 5) Percent of cases seen
in a Hospital in relation to cases seen in a HCF; 6) percent of cases
taken to an Intensive Care Unit (ICU) in relation to cases seen in a
HCF.

Table 2. Relative Frequency of Acute Pesticide Poisoning Incidents by
Symptom Severity: Non-Occupational Cases 

	Severity of outcome

(outcome determined)	Total

exposed	Health care 

provided

Denominator numbers	10	26	3

Measures	SYM1	MOD2	MAJ3	HCF4	HOSP5	ICU6

Numerator numbers	5	1	0	3	1	1

Fenoxycarb percents	50.00%	10.00%	0.00%	11.54%	33.33%	33.33%

All Pesticides percents	64.72%	10.61%	0.45%	15.45%	7.94%	3.02%

Ratio of  Fenoxycarb

to average of all pesticides	0.77 

P =0.33	0.94

P = 0.95	0.00

P = 0.83	0.75

P = 0.57	4.20 

P = 0.10	11.04 (S)

P =0.00 (*)

1) Percent of cases with ANY symptom in relation to the total of cases
followed; 2) Percent with moderate symptoms in relation to the total of
cases followed; 3) Percent with major or fatal outcome in relation to
the total of cases followed; 4) Percent of case seen in a Health Care
Facility (HCF) in relation to total exposures; 5) Percent of cases seen
in a Hospital in relation to cases seen in a HCF; 6) percent of cases
taken to an Intensive Care Unit (ICU) in relation to cases seen in a
HCF.

 (*) Sample size not big enough for a reliable test.

Table 3. Relative Frequency of Acute Pesticide Poisoning Incidents by
Symptom Severity: Children Cases 

	Severity of outcome

(outcome determined)	Total

exposed	Health care 

provided

Denominator numbers	21	35	5

Measures	SYM1	MOD2	MAJ3	HCF4	HOSP5	ICU6

Numerator numbers	3	0	0	5	0	0

Fenoxycarb percents	14.29%	0.00%	0.00%	14.29%	0.00%	0.00%

All Pesticides percents	23.16%	1.48%	0.13%	14.80%	4.48%	1.41%

Ratio of  Fenoxycarb

to average of all pesticides	0.62

P =0.34	0.00

P = 0.57	0.00

P = 0.86	0.97 

P = 0.93	0.00 

P = 0.62	0.00

P =0.78

1) Percent of cases with ANY symptom in relation to the total of cases
followed; 2) Percent with moderate symptoms in relation to the total of
cases followed; 3) Percent with major or fatal outcome in relation to
the total of cases followed; 4) Percent of case seen in a Health Care
Facility (HCF) in relation to total exposures; 5) Percent of cases seen
in a Hospital in relation to cases seen in a HCF; 6) percent of cases
taken to an Intensive Care Unit (ICU) in relation to cases seen in a
HCF.

Table 4. Relative Frequency of Acute Pesticide Poisoning Incidents by
Symptom Severity: Combination of All Cases Regardless Class 

	Severity of outcome

(outcome determined)	Total

exposed	Health care 

provided

Denominator numbers	45	77	18

Measures	SYM1	MOD2	MAJ3	HCF4	HOSP5	ICU6

Numerator numbers	22	3	0	18	1	1

Fenoxycarb percents	48.89%	6.67%	0.00%	23.38%	5.56%	5.56%

All Pesticides percents	42.69%	6.02%	0.29%	16.01%	6.05%	2.16%

Ratio of  Fenoxycarb

to average of all pesticides	1.15

P =0.40	1.11

P = 0.85	0.00

P = 0.71	1.46

P = 0.09	0.92

P = 0.93	2.57 

P =0.32

1) Percent of cases with ANY symptom in relation to the total of cases
followed; 2) Percent with moderate symptoms in relation to the total of
cases followed; 3) Percent with major or fatal outcome in relation to
the total of cases followed; 4) Percent of case seen in a Health Care
Facility (HCF) in relation to total exposures; 5) Percent of cases seen
in a Hospital in relation to cases seen in a HCF; 6) percent of cases
taken to an Intensive Care Unit (ICU) in relation to cases seen in a
HCF.

Table 5 provides a summary by year, and Figure 1 shows a graphical
summary for annual exposure, symptomatic cases, and cases seen in a
health care facility.  

Table 5. Summary of Cases by Year

Summary of Cases by Year

Year	Symptomatic

Cases	Moderate

Cases	Major

Cases	Cases 

Followed	Total Exposed	HCF

Cases	Hospital

Cases	ICU

Cases

1993	4	2	0	6	13	3	1	1

1994	2	0	0	4	7	2	0	0

1995	8	0	0	15	21	5	0	0

1996	4	0	0	8	11	4	0	0

1997	1	0	0	4	8	2	0	0

1998	1	0	0	2	3	0	0	0

1999	2	1	0	5	8	2	0	0

2000	0	0	0	0	2	0	0	0

2001	0	0	0	0	1	0	0	0

2002	0	0	0	0	1	0	0	0

2003	0	0	0	0	0	0	0	0

2004	0	0	0	1	2	0	0	0

2005	0	0	0	0	0	0	0	0

Total	22	3	0	45	77	18	1	1

Figure 1 Total exposure, symptomatic cases, and cases sent to HCF by
year

Analysis of Results

For the occupational class, no percentage of Fenoxycarb is statistically
different from the percentages for the composite of all pesticides. The
table shows a small number of exposures cases; only 16 cases in the
period 93-05. Similar results are observed in the non-occupational
class. With 26 exposures reported in 13 years, the non-occupational
class shows low ratios; only one case produced moderate symptoms that
triggered health care activity. The results for Fenoxycarb on children
produced non-significant lower ratios in all columns.  For the entire
population, results are not significantly different from the composite
average of all pesticides.

A diminishing trend in total exposure, symptomatic cases, and cases seen
in a HCF is apparent for the 13 year-span of data collected on
Fenoxycarb with very few cases occurring since 2000. Calculations show
an average of about 5.9 exposures per year, 1.7 symptomatic cases per
year, and 1.4 cases per year seen in a heath care facility.

Based on PCC reports, exposure to Fenoxycarb produced health symptoms
concentrated in two main areas, and within each area, the symptoms were:

Gastro Intestinal: nausea, abdominal pain, and

Neurological: headache, and dizziness/vertigo

2. Cases reported in the Incident Data System from 1999 to the present

Seventeen cases were reported in the IDS. For a detailed description,
see Attachment 1.

3. NIOSH SENSOR

Out of 5,899 reported cases from 1998 to 2003, there is only one case
reported in the SENSOR database involving Fenoxycarb. A 31-year-old
woman reported symptoms in Texas. The symptoms were nausea, lacrimation
and dyspnea/shortness of breath with no medical treatment sought. 

Study Summary

The summary findings for the period 1999 to 2003 for Fenoxycarb are:

Fenoxycarb does not produce any significant results in any of the
classes when compared to the composite of all pesticides.

Fenoxycarb data shows low averages results with about 5.9
exposures/year, 1.7 symptomatic cases/year, and 1.4 cases/year seen in a
heath care facility. 

No apparent annual trend is noticed in the 13 year-span, however the
data shows very low incidents in the last six years.

Conclusions/ Recommendations

Based on the incident data reviewed from the above sources, OPP suggests
no mitigation actions for Fenoxycarb at this time. 

Attachment 1.

Cases from the Incident Data System (IDS) for Fenoxycarb

Summary: There are 17 incident reports highlighted below. The last case
that was reported to the IDS was in 1998. The cases below provide a
sense of symptoms and circumstances where exposures were reported to
IDS. While IDS did not confirm life-threatening symptoms in these
reports from indoor and outdoor incidents, there were prevention
opportunities, as mention of an allergic reaction suggests a possible
situation that could progress to a life-threatening situation in persons
with pre-existing disease or a history of allergic reactions.

Incident#994-1

	A pesticide incident occurred in 1994, when the product was applied on
carpet in a bank.  Eighteen workers reported breathing problems, nausea,
headache, and sore throat.  The workers were treated by a physician.  No
further information on the disposition of the case was reported.

Incident#3640-1

	A pesticide incident occurred in 1996, when a pest control operator was
sprayed in the face with the product when a hose burst.  The operator
immediately turned off the pressure and little was released.  He rinsed
himself off, including his eyes, and used an absorbent material to clean
up the spill.  Specific symptoms were not mentioned.  No further
information on the disposition of the case was reported.

Incident#4697-15

	Lawsuit.

Incident#4697-70

	Lawsuit.

Incident#5895-42

	A pesticide incident occurred in 1995, when an individual was exposed
to the product while spreading a machine and the wind deposited some of
it into his ear.  The man reported ear pain and a swollen ear.  No
further information on the disposition of the case was reported.

Incident#5895-43

	A pesticide incident occurred in 1996, when a pregnant woman was
exposed to the product when a room was treated with it.  The woman
reported pulmonary irritation.  No further information on the
disposition of the case was reported.

Incident#5895-289

	A pesticide incident occurred in 1993, when an individual, who wore
gloves, was exposed while the product was applied around the house.  The
individual reported an allergic reaction including itching, blistering. 
No further information on the disposition of the case reported. 

Incident#5895-292

	A pesticide incident occurred in 1996, when a man’s daughter was
exposed to the product after the lawn was treated with it.  She reported
a rash on her entire body area, swollen eyes, forehead and feet and a
fever.  No further information on the disposition of the case was
reported.

Incident#5895-297

	A pesticide incident occurred in 1994, when an individual was exposed
to the product while spreading it.  The individual reported vomiting,
burning eyes, tremors, and diaphoresis.  No further information on the
disposition of the case was reported.

Incident#5895-527

	A pesticide incident occurred in 1993, when an individual was exposed
to the product after it was applied in their home.  The individual
reported a rash on their body.  No further information on the
disposition of the case was reported.

Incident#5895-529

	A pesticide incident occurred in 1995, when an individual was exposed
to the product after it was used in a home.  The individual reported
malaise.  No further information on the disposition of the case was
reported.

Incident#5895-531

	A pesticide incident occurred in 1996, when an individual was exposed
to the product when an occupied building was treated with it.  The
individual reported respiratory difficulty and a skin rash.  No further
information on the disposition of the case was reported.

Incident#5895-532

	A pesticide incident occurred in 1994, when an individual was exposed
to the product after it was used in the hospital.  The individual
reported headaches, sore throats, facial numbness, and nausea.  No
further information on the disposition of the case was reported.

Incident#5895-533

	A pesticide incident occurred in 1995, when an individual was exposed
to the product after their house was treated with it.  The individual
reported respiratory arrest (wheezing/heaving), and chest tightness.  No
further information on the disposition of the case was reported.

Incident#5895-534

	A pesticide incident occurred in 1992, when the product was applied at
a bank.  The individual reported emotional distress and chest tightness.
 No further information on the disposition of the case was reported.

Incident#5895-574

	A pesticide incident occurred in 1995, when a woman and her husband
were exposed after spraying the product in a house.  They reported
nausea, vomiting, severe headache, and tingling sensations in their
hands and feet.  No further information on the disposition of the case
was reported.

Incident#7235-1

	A pesticide incident occurred in 1998, when an individual applied the
product to 28 acres of an airstrip.  The individual reported difficulty
breathing, runny nose, and coughing.  No further information on the
disposition of the case was reported.



Attachment 2.

Table Description

The following is a general description of the table components that
compares the pesticide of interest with the composite average of all
pesticides. The table produces ratios in several health and exposure
measurements.

Table 1 General Explanation of Comparison of the Pesticide of Interest
with the Composite Average of all Pesticides.

	Severity of Outcome

(Outcome determined)	Total

Exposed	Health Care 

Provided

Denominator numbers	25,549	68,005	18,084

Measures	SYM	MOD	MAJ	HCF	HOSP	ICU

Numerator numbers	578	83	9	18,084	302	219

Pesticide “X” percents	2.26%	0.32%	0.03%	26.59%	1.67%	1.21%

All Pesticides percents	21.72%	1.42%	0.12%	15.68%	4.34%	1.75%

Ratio of  “X”

to average of all pesticides	0.10(S)

P =0.00	0.23 (S)

P = 0.00	0.25 (S)

P = 0.01	1.69 (S)

P = 0.00	0.38 (S)

P = 0.00	0.69 

P =0.51

A) The firs row, or title row, divides the table in three sub-tables
“Severity of Outcome”, “Total Exposed”, and “Health Care
Provided”

B) The second row “Denominator numbers” presents the numbers
extracted from the PCC database for the pesticide of interest “X”
that will serve as denominators in the calculation of the percents, and
they are:

In the center column, total amount of individuals exposed to pesticide
“X” (n = 68,005) or “Total Exposed”. These are cases collected
by the Poison Control Center for the period of interest regardless of
outcome. 

In the left column under “Severity of Outcome”, is the number of
cases followed, (n = 25,546). These cases have an outcome determined
“Outcome determined” and these cases may  or may not have symptoms.

At the right of the table, cases that visited a Health Care Facility (n
= 18084) “Health Care Provided”.

C) The third row “Measures” describes the clinical outcome and level
of care required for the exposed cases: 

“SYM” are those cases that were symptomatic; 

“MOD” cases are those that were classified with moderate symptoms; 

“MAJ” cases were cases classified as major symptoms or fatal
outcome; 

“HCF” are cases that went to a Health Care Facility; 

“HOSP” are cases that went to a hospital; and 

“ICU” are cases that went to an Intensive Care Unit.

D) The fourth row “Numerator numbers” is actually the number of
cases for pesticide “X” that presented the outcome describe in the
“Measures” row. The numbers in this row are inclusive. This is, a
case classified as “Major”, is first classified as
“Symptomatic”, and also classified as “Moderate”; so a
“Major” case will count on the three measurements. The same scenario
applies to the “Health Care Provided” section; a case classified as
“ICU” also counts as a case that went to a “HCF” and to a
“Hospital”. In addition, a case classified as “Hospital” will
count also in “HCF” but not on “ICU”

E) The fifth row “Pesticide “X” percents” gives the percentages
on each measure. These percentages are calculated by dividing the
numerator number by the denominator number (from each major section of
the Table 1) and multiplying by 100. For example, to calculate SYM, MOD,
and MAJ, the numbers 578, 83 and 9 are divided by 25,549 on the first
row, producing the respective percents 2.26%, 0.32%, and 0.03%.  In a
similar fashion 18,084 is divided by 68,005 for the percentage of cases
seen in a HCF of 26.59%; and for the last section of the fifth row, 302
and 219 are divided by 18,084 to find the percentages, 1.67% and 1.21%, 
of cases that went to a “Hospital” and “ICU”. 

F) The sixth row “All Pesticides Percents” are percentages that were
previously calculated using all pesticide cases available in the PCC
database with the exception of cases involving exposures to multiple
products, cases with unrelated medical outcome, and cases where the
exposure was intentional. These exclusions make the comparison more
meaningful for US EPA regulatory program purposes. The percentages serve
as the baseline for the comparison with a single pesticide or a group.
These percentages are a unique characteristic for the “class” and
“period” of the data assembled in the table, and are completely
independent of the previously calculated values for pesticide “X”.

 

	G) The last row “Ratio of “X” to average of all pesticides” is
obtained by dividing the percentages of the “X” compound by the
“all pesticides” percentages, to obtain a dimensionless number or
ratio. This ratio provides an idea of the relative frequency of the
compound “X”. For example, a ratio of 1 (one) indicates that the
percentages are the same for the compound “X” and the composite of
all pesticides; a ratio, say of 2 (two), indicates that the chemical
under study produces twice the effect; and a ratio of 0.5 indicates that
the compound has half of the activity of the composite average. These
ratios provide a quick overview of the relative toxicity of the
chemical.

H) Also, the “p” value that results from a Likelihood ratio test is
entered in the ratio cell and when significant (p < 0.05) then an (S) is
entered next to the ratio to mark statistical significance. A cell
marked with (S) means that the percentages that produce the ratios are
“statistically” different and not due to chance. The percentage of
pesticide “X” could be higher or lower than the percentage produce
by the composite as indicated by the ratio. However, when mark by an (S)
the difference is significant. For example, a ratio = 1.6 (S) means the
effect produced by the compound is higher that the effect produced by
the composite and statistically different; a ratio = 0.7 (S) signifies
that pesticide “X” has a lower
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