FDA Statement on "Scientific Criteria to Ensure Safe Food,"
a Report by the National Academy of Sciences
The National Academy of Sciences' report, "Scientific
Criteria to Ensure Safe Food," commissioned by FDA and the U.S.
Department of Agriculture, reinforces the progress FDA has already
made in reducing and preventing food borne illness. The report (
FDA Talk
Paper) specifically attributes some of this progress to the adoption
of the Hazard Analysis and Critical Control Point (HACCP) approach
to food safety - which FDA has already applied to seafood, fresh juice,
and is voluntarily applied in the dairy industry.
The report also calls for clearer links,
in the overall U.S. food safety system, between food safety standards
and public health outcomes. FDA supports this general goal as a
sound public health approach, and has already made progress in reducing
the incidence of food borne illness in collaboration with Healthy People
2010 and CDC's FoodNet and Pulsnet. Programs such as these are instrumental
in reduction of food borne illness and in promoting of preventive
controls such as HACCP.
FDA has set a goal of reducing food
borne illness associated with
Salmonella enteriditis in shell
eggs by establishing regulations including labeling, refrigeration
and other preventive controls.
FDA's strong system for regulating
food safety and security is based on sound and up-to-date science,
including the science of risk assessment. Its collaboration with
the U.S. Centers for Disease Control and Prevention and the USDA
on such innovative food borne illness tracking systems as FoodNet
and PulseNet have greatly strengthened the Federal government's ability
to manage outbreaks of food borne illness.
FDA is committed to continuing its
close collaboration with its public health partners at all levels
of government to make the current food safety system as effective
as possible. The agency remains open to new solutions and approaches
to ensuring food safety and security.
To the extent that the NAS report
calls for new legislative authority and additional resources, FDA
will work closely with the Administration and the Congress to evaluate
any innovations designed to make the U.S. food supply even safer.
REF: FDA Talk Paper, April 25, 2003.
Use of Agricultural Pesticides and Prostate Cancer Risk
in the Agricultural Health Study Cohort
The authors examined the relation between 45
common agricultural pesticides and prostate cancer incidence in
a prospective cohort study of 55,332 male pesticide applicators from
Iowa and North Carolina with no prior history of prostate cancer.
Data were collected by means of self-administered questionnaires
completed at enrollment (1993-1997). Cancer incidence was determined
through population-based cancer registries from enrollment through
December 31, 1999. A prostate cancer standardized incidence ratio was
computed for the cohort. Odds ratios were computed for individual pesticides
and for pesticide use patterns identified by means of factor analysis.
A prostate cancer standardized incidence ratio of 1.14 (95% confidence
interval: 1.05, 1.24) was observed for the Agricultural Health Study
cohort. Use of chlorinated pesticides among applicators over 50 years
of age and methyl bromide use were significantly associated with prostate
cancer risk. Several other pesticides showed a significantly increased
risk of prostate cancer among study subjects with a family history of
prostate cancer but not among those with no family history. Important family
history-pesticide interactions were observed.
Odds ratios for prostate cancer increased sharply
with age, and cases were more likely to have a family history of
prostate cancer. Nineteen percent of prostate cancer cases reported
a family history of prostate cancer among first-degree relatives, compared
with 8.6 percent of noncases. A nearly significant positive association
was observed for cigarette smoking.
In conclusion, farmers and commercial
pesticide applicators have a small but significantly higher rate
of prostate cancer than the general population of Iowa and North Carolina.
Occupational use of a widely used halogenated fumigant, methyl bromide,
was shown to be significantly associated with a risk of prostate
cancer in the Agricultural Health Study cohort among those with the
highest exposure. A pattern of chlorinated pesticide use may also be
related to prostate cancer risk. A family history of prostate cancer appeared
to significantly modify the prostate cancer risks among those using several
widely used insecticides, including chlorpyrifos, coumaphos, fonofos,
phorate, and permethrin for animal use, and a herbicide, butylate. The
methyl bromide and family history findings are novel and unexpected and
need to be confirmed in later follow-up periods in this cohort and in other
studies of prostate cancer in farmers.
REF: Am J Epidemiol
2003; 157:800-814.
DPR Announces
Restrictions to Protect Compost
The California Department of Pesticide
Regulation (DPR) has announced new pesticide restrictions to protect
commercial compost from potential contamination. DPR will restrict sales
of the herbicide clopyralid ("clo-PEER-ah-lid") to lawn and turf professionals,
instruct those licensees to assure that green waste stays onsite when
the herbicide is used, and require dealers to provide written notice
of the restrictions when they sell some clopyralid products. DPR will
immediately begin drafting regulations to enforce those restrictions,
based on concern that clopyralid residue in grass clippings could make
compost toxic to non-target vegetation.
DPR expects its restrictions to affect about
15 clopyralid products used in parks, playing fields, and cemeteries.
Golf courses were exempted after DPR determined that grass cycling onsite
is a standard industry practice, and clopyralid product labels prohibit
use on tees and greens. Clopyralid products labeled for farm, rangeland,
and forest use are not affected. DPR took initial action against residential
uses in March 2002.
Used to control broadleaf weeds, clopyralid is
a low-toxicity chemical that poses little hazard to people, animals,
and most vegetation. However, even low levels of clopyralid in compost
may damage some plants. Some commercial compost facilities in California
have detected clopyralid residues, but no cases of non-target vegetative
damage have been documented in the state.
"This action underscores our commitment
to California's environment in general and to the compost industry
in particular," said DPR Director Paul Helliker. "Clopyralid is a useful
pesticide, but some applications could cause a problem if residues accumulate
in the green waste stream. We've worked closely with the Integrated
Waste Management Board to protect the green waste stream while preserving
beneficial uses of this herbicide," said Helliker.
"Using organic material to make compost is an
essential part of our efforts to prevent valuable resources from ending
up in landfills, a major reason why California's statewide diversion
rate has grown to 48 percent," said Linda Moulton-Patterson, Chair of the
Integrated Waste Management Board (IWMB). "We are very pleased with the
Department's determination to further limit the use of clopyralid. It
is a crucial step in protecting the viability of compost markets and
the continued success of our waste diversion efforts."
In March 2002, DPR announced it would seek cancellation
of 15 clopyralid products registered for residential lawn use, citing
a potential hazard to compost. Dow AgroSciences, which registered the
herbicide in California, subsequently asked the U.S. Environmental Protection
Agency for product label changes to address DPR's concerns. Since U.S.
EPA allowed Dow time to clear existing stocks from dealer shelves, products
with the new labels are expected to appear in the market later this year.
DPR's action fulfills a charge by Assembly Bill
2356 (Keeley), passed in 2002. It directed DPR to assess the possibility
that clopyralid residues could persist in compost and either impose
restrictions or cancel registration of those uses.
Clopyralid was initially registered for use in
California in 1997 to combat yellowstar thistle, a noxious weed that
can kill livestock.
DPR and IWMB began investigating clopyralid residues
in compost about 18 months ago. The two Cal/EPA agencies co-sponsored
a workgroup that included compost industry representatives, Dow, and
other interested parties. The group held four meetings in the past year
to explore how clopyralid residues enter the green waste stream, what
residue levels may pose a risk to non-target vegetation, and other
relevant information. Among the findings:
- - Compost monitoring data varied. While the frequency
of residue detections declined, low levels of clopyralid continued
to show up in some samples.
- - Sales data from DPR's pesticide assessment database and Dow
AgroSciences suggested sales of turf products declined in the past
12 to 18 months.
- - Dow AgroSciences has made significant efforts to educate
its product dealers and users about compost issues, and Dow advised
users to discontinue residential lawn uses of clopyralid after DPR
initiated cancellation action for that use.
- - Professional lawn and turf associations and the
University of California Cooperative Extension Service raised awareness
of the issue in meeting presentations, magazine articles, newsletters
and Web postings.
- - No phytotoxicity resulting from clopyralid in
compost has been reported to DPR during the last 18 months. A recently
submitted study examined the phytotoxicity of clopyralid to sensitive
plants under defined conditions of soil/compost and compost/peat combinations
with varying levels of clopyralid. The Dow-funded study suggested a low
probability of phytotoxicity on sensitive plants, given detected levels
in California compost. Members of the compost industry reviewed a summary
of the study and discussed it with DPR.
However, AB 2356's definition for persistent
residues in compost covered a broad range of characteristics with
potential toxicity: "residues of an herbicide in compost at levels and
in a form with the potential to be toxic or injurious to plants." Based
on the law and the joint investigation with IWMB staff, DPR acknowledged
the potential diverse uses of compost in commercial agriculture, the
nursery industry, and home gardens. Under the law's criteria, DPR determined
it was possible that persistent residues in compost could occur from turf
uses of clopyralid.
REF: California Department of Pesticide Regulation
News, April 2, 2003 (03-08).
Multistate
Outbreak of Salmonella Serotype Typhimurium Infections
Associated with Drinking Unpasteurized Milk
Illinois, Indiana, Ohio, and Tennessee, 2002-2003
On December 10, 2002, the Clark County Combined
Health District and the Ohio Department of Health (ODH) were notified
of two hospitalized children infected with
Salmonella Enterica serotype
Typhimurium. Initial investigation implicated consumption of raw, unpasteurized
milk purchased at a local combination dairy-restaurant (dairy) during November
27-December 13, 2002, as the cause. This report summarizes the subsequent
investigation. Because 27 states still allow the sale of raw milk, and organizations
continue their efforts to allow marketing and sale of raw milk to the public
directly from the farm consumer education about the hazards of raw milk
and a careful review of existing policies are needed.
The dairy comprised a working dairy farm, restaurant,
snack bar, and petting zoo with goats, cows, calves, lambs, and pigs.
At the time of the epidemiologic investigation in December 2002, the workforce
comprised 211 workers, including 16 members of the owner family. In
2002, the dairy was the only place in Ohio that sold raw milk in jugs
and served raw milk and milk shakes made with raw milk legally to customers.
In 2001, approximately 1,350,000 customers visited the dairy.
During November 30, 2002-February 18, 2003, ODH
laboratory received 94
S. Typhimurium
clinical isolates
for pulsed-field gel electrophoresis (PFGE) testing. Of these, 60 had
an indistinguishable pattern. In addition, patterns from Illinois, Indiana,
and Tennessee matched the Ohio pattern.
A total of 62 persons had illness consistent
with the case definition, including 40 customers, six household contacts,
and 16 (7.6%) of 211 dairy workers; patients were from four states (Illinois,
Indiana, Ohio, and Tennessee); the median age was 18 years (range: 1-70
years), and 34 (54.8%) were females. Of the 62 patients, 54 (87.1%) reported
signs and symptoms of illness, including diarrhea (52 [96.3%]), cramps
(41 [75.9%]), fever (37 [68.5%]), chills (29 [53.7%]), body aches (29
[53.7%]), bloody diarrhea (27 [50.0%]), nausea (25 [46.3%]), vomiting (24
[44.4%]), and headache (21 [38.9%]). A total of 50 (80.6%) exhibited more
than one symptom. Disease onset occurred during November 30, 2002-January
14, 2003.
A case-control study was conducted to verify
the initial findings implicating raw milk and to identify other potential
sources of infection. A total of 40 case-patients and 56 controls were
eligible for the case-control study. In the univariate analysis of
potential risk factors, only consumption of raw milk was associated significantly
with illness. Among 39 case-patients and 55 controls for whom date of milk
purchase was known, 37 (94.9%) and 16 (29.1%), respectively, consumed raw
milk. Consumption of other food items, visiting the petting zoo, and petting
animals were not associated with illness.
Of the 32 food samples tested, five were positive
for
S. Typhimurium, including three raw skim milk samples, one
sample of butter made from raw milk purchased by a customer, and one sample
of cream. Skim milk samples were taken from milk either bought or bottled
on November 29. The 31 animal stool samples collected from cows
providing milk and the 23 environmental samples taken from dairy equipment
and storage sites were negative for
S. Typhimurium.
The review of the dairy operation and results
of worker screening tests revealed that four barn workers had asymptomatic
S. Typhimurium infection. Barn workers milked the cows, bottled
the milk, and made ice cream.
On December 13, 2002, following an order from
local health authorities, the dairy discontinued the sale of all raw milk
products. On January 13, 2003, the Ohio Department of Agriculture (ODA)
recommended that the sale of all dairy products made with raw milk, including
bottled raw whole milk, skim milk, and cream, be discontinued permanently.
Several sanitation improvements, primarily for the barn workers, also
were recommended, including more frequent hand washing, replacement
of the some of the equipment and utensils (e.g., mixing bowls), and enhanced
general cleaning in the entire property.
Editorial Note: Each year in the United States, foodborne
disease causes an estimated 76 million illnesses. Of these, an estimated
1.4 million are caused by
Salmonella, resulting in approximately
16,000 hospitalizations and 580 deaths. Raw bulk tank milk can contain
one or more species of pathogenic bacteria, including
Salmonella spp.
During 1972-2000, a total of 58 raw milk-associated outbreaks were reported
to CDC, of which 17 (29%) were caused by
Salmonella spp.
This report describes a large multistate outbreak of
S. Typhimurium
transmitted through consumption of raw milk and milk products. Although
animal and environmental samples were negative for
S. Typhimurium,
four barn workers were infected with
S. Typhimurium. The source
for contamination was not determined; however,
the findings suggest
that contamination of milk might have occurred during the milking, bottling,
or capping process.
In 2002, intrastate sale of raw milk for human consumption was
legal in 28 states, including Ohio. As of October 1997, Ohio law did not
allow the sale of raw milk except for dairies that were engaged continuously
in the business of selling or offering for sale raw milk directly to consumers
before October 31, 1965. The dairy in this outbreak had been in operation
since 1958 and was the only place in Ohio selling raw milk legally. After
ODA issued its recommendations, the dairy voluntarily relinquished its
license for selling raw milk. As a result, no businesses now sell raw milk
to the public legally in Ohio.
Despite the known association of raw milk with disease-causing
organisms, some consumers believe that raw milk is of better quality than
pasteurized milk. In several states, producers circumvent regulations
and provide raw milk to consumers by establishing cow-leasing programs
in which farmers keep and milk cows owned by individuals. Consumer education
about the hazards of raw milk consumption is needed. Retail milk regulations
should be reviewed and strengthened, if needed, to minimize exposure
of the public to the hazards of raw milk consumption.
Editorial Note: This case is of interest because
it was not the cows who were responsible for the contamination, but
asymptomatic workers who were carriers and who were not taking proper
steps to prevent contamination of the milk.
REF: Centers for Disease Control and Prevention, Morbidity
and Mortality Weekly Report, July 4, 2003, 52(26);613-615.
Suspected
Moonflower Intoxication - Ohio, 2002
During October 11-November 20, 2002, the Cincinnati
Drug and Poison Information Center (DPIC) received notification of and
offered treatment advice for 14 adolescents in the Akron/Cleveland, Ohio,
area who became ill after intentional exposure to toxic seeds that DPIC
identified as
Datura inoxia (see Figure). All became ill shortly
after eating the seeds or drinking tea brewed using the seeds. All patients
recovered fully after treatment. This report summarizes these cases, discusses
the characteristics of the various plants known commonly as "moonflowers,"
and underscores the need for awareness of the potential toxicity from recreational
use of a plant.
Of the 14 patients, 12 (86%) were male; median age was 17 years (range:
12-19 years). All 14 patients reported to the emergency department (ED)
with anticholinergic signs and symptoms, including dilated pupils, tachycardia,
hallucinations, and urinary retention. Signs and symptoms typically lasted
24-48 hours, and the illness resolved with supportive care and benzodiazepine
administration. No long-term effects were documented.
On November 5, a local newspaper described some of the cases of "toxic
seed" exposure. Use of the common name moonflower had led to some confusion
about which of the several moonflower plants were involved in these exposures.
Parents of several adolescents who ingested these seeds as a group reported
that the seeds were from a moonflower plant, specifically
D. inoxia,
and noted that this plant was cultivated widely and available in local
garden stores. On the basis of clinical presentations and a photograph
taken of a plant submitted to the ED by one of the parents, a toxicologist
at DPIC agreed that
D. inoxia was the source of these illnesses.
Editorial Note: Moonflower is not on the U.S. Drug Enforcement
Agency's list of controlled substances, but local law enforcement measures
in the Akron/Cleveland area prohibit selling seedpods for illicit use.
The cluster of moonflower exposures reported to DPIC might represent a
new form of substance abuse in the Akron/Cleveland area. The illicit use
of this plant might be related to the increasing knowledge of moonflower's
hallucinogenic properties combined with the local availability of this
plant.
Plants with large fragrant flowers that bloom at dusk are referred
to as moonflowers. Poisindex® lists two species as moonflower:
Ipomoea
muricata (purple moonflower) and
I. alba (white moonflower).
Ingestion of
I. muricata might cause hallucinations and cholinergic
effects such as diaphoresis, salivation, lacrimation, and diarrhea. Neither
hallucinations nor other anticholinergic effects occur with
I. alba
poisoning.
The clinical features of cases reported to DPIC are most consistent
with the anticholinergic properties of
Datura species
.
Scopolamine and hyoscyamine, both of which are major constituents of
Datura species, are most concentrated in the seeds and can cause
anticholinergic poisoning in exposed persons.
Symptoms of
Datura toxicity occur typically within 60 minutes
after ingestion and continue for 24-48 hours. Ingestion of
Datura
manifests as a classic anticholinergic syndrome comprising central
and peripheral signs and symptoms. Central toxic effects include confusion,
agitation, anxiety, hallucinations, seizures, and coma. Peripheral toxic
effects include dry mucous membranes, thirst, flushed face, blurred vision,
hyperthermia, urinary retention, and decreased gut motility.
D. inoxia is a plant with large white flowers that blooms
at dusk; it has a bushy growth habit with up to 200 seeds borne in pods
with closely spaced thorns.
D. inoxia is related to another commonly
abused plant,
D. stramonium (jimson weed).
D. stramonium has
clinical features of toxicity similar to
D. inoxia. The plant features
described by the parents of the exposed adolescents are consistent with
D.
inoxia but not
D. stramonium or the other moonflower plants.
This report highlights four important points. First, the clinical
effects of recreational use of a plant might vary drastically from the
desired effects. Adolescents and parents should be aware of the potential
toxicity from recreational use of a plant and the need for medical attention
if an exposure occurs. Second, gardening practices in a community might provide
novel opportunities for experimenting with intoxicating substances. Because
D. inoxia is used as an ornamental plant in the Akron/Cleveland area,
local garden suppliers should discuss the potential toxicity of the plant
at the time of purchase. Third, because toxicity differs for various plants
of this type, use of the common name moonflower can be misleading clinically
and might complicate identification of some species. Finally, poison control
centers can detect new trends in drug abuse or poisonings and provide information
that local and state health departments can use to inform the public.
REF: Centers for Disease Control and Prevention,
Morbidity and Mortality Weekly Report, August 22, 2003 /
52(33);788-791
Application of Pesticides
to U.S. Waters
Interim Statement and Guidance on Application of Pesticides to
Waters of the United States in Compliance with FIFRA
SUMMARY: In a July 11, 2003, memorandum, the
Environmental Protection Agency (EPA) issued, as an Interim Statement
and Guidance, an interpretation of the Clean Water Act (CWA) to resolve
jurisdictional issues pertaining to pesticides regulated under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) that are applied to
waters of the United States.
The interpretation addresses two sets of
circumstances for which EPA believes that the application of a pesticide
to waters of the United States consistent with all relevant requirements
of FIFRA does not constitute the discharge of a pollutant that requires
a National Pollutant Discharge Elimination System (NPDES) permit under
the Clean Water Act: the application of pesticides directly to waters of
the United States in order to control pests (for example mosquito larvae
or aquatic weeds that are present in the water) and the application of pesticides
to control pests that are present over waters of the United States that
results in a portion of the pesticide being deposited to waters of the United
States (for example when insecticides are aerially applied to a forest canopy
where waters of the United States may be present below the canopy or when
insecticides are applied for control of adult mosquitoes). EPA issued
this statement pursuant to its authority under Section 301 of the Clean Water
Act. EPA is soliciting and will consider comment on this interim statement
and guidance before determining a final Agency position.
EPA will continue to review the variety of circumstances
in which questions have been raised about whether applications of pesticides
to waters of the U.S. are regulated under the CWA. As EPA determines the
appropriate response to these circumstances, we will develop additional
guidance. This memorandum addresses two sets of circumstances for which
EPA believes that the application of a pesticide to waters of the United
States consistent with all relevant requirements of FIFRA does not constitute
the discharge of a pollutant that requires an NPDES permit under the Clean
Water Act:
(1) The application of pesticides directly to waters of
the United States in order to control pests. Examples of such applications
include applications to control mosquito larvae or aquatic weeds that
are present in the waters of the United States.
(2) The application of pesticides to control pests that
are present over waters of the United States that results in a portion
of the pesticides being deposited to waters of the United States; for example,
when insecticides are aerially applied to a forest canopy where waters
of the United States may be present below the canopy or when insecticides
are applied over water for control of adult mosquitos.
It is the Agency's position that these
types of applications do not require NPDES permits under the Clean Water
Act if the pesticides are applied consistent with all relevant requirements
of FIFRA. Applications of pesticides in violation of the relevant
requirements of FIFRA would be subject to enforcement under any and
all appropriate statutes including, but not limited to FIFRA and the
Clean Water Act. This interpretation also does not preclude or nullify
any existing authority vested with States or Tribes to impose additional
requirements on the use of pesticides to address water quality issues
to the extent authorized by federal, state or tribal law.
For the full text of the Memorandum go to:
Federal Register
(and scroll down to Environmental Protection Agency)
REF: Federal Register: August 13, 2003 (Volume
68, Number 156)
Surveillance for Acute Insecticide-Related
Illness Associated
with Mosquito-Control Efforts - Nine States, 1999-2002
Ground and aerial applications of insecticides are
used to control populations of adult mosquitoes, which spread such diseases
as West Nile virus-related illness, eastern equine encephalitis, and dengue
fever. This report summarizes investigations of illnesses associated with
exposures to insecticides used during 1999-2002 to control mosquito populations
in nine states (Arizona, California, Florida, Louisiana, Michigan, New
York, Oregon, Texas, and Washington) (estimated 2000 population: 118 million).
The findings indicate that application of certain insecticides posed
a low risk for acute, temporary health effects among persons in areas that
were sprayed and among workers handling and applying insecticides.
To reduce the risk for negative health effects, public health authorities
should 1) provide public notice of application times and locations and
appropriate advice about preventing exposures, 2) ensure that insecticide
handlers and applicators meet state-mandated training and experience requirements
to prevent insecticide exposure to themselves and the public, and 3) implement
integrated pest management control strategies that emphasize mosquito larval
control, reduction of mosquito breeding sites, and judicious use of insecticides
to control adult mosquito populations.
Cases of insecticide-related illness or injury were
classified as either definite, probable, or possible, depending on the certainty
of exposure and whether health effects were signs observed by a health-care
provider or symptoms reported by a patient. Of the 133 cases of acute insecticide-related
illness associated with mosquito control that were identified, two (1.5%)
were classified as definite, 25 (18.8%) as probable, and 106 (79.7%) as
possible. Of the 132 cases for which work-relatedness could be assessed,
36 (27.3%) were work-related and 96 (72.7%) were not work-related; 31 (86.1%)
of the 36 work-related cases occurred among males, and 66 (68.8%) of the
96 cases that were not work-related occurred among females.
Of the 49 cases identified in 2001, a total of 29
(59.2%) were related to a single event at a softball game in which workers
operating a mosquito-control truck inadvertently sprayed 29 persons (16
spectators, 12 players, and one coach) with Fyfanon ULV®, which contains
malathion. All 29 persons were treated in emergency departments (EDs).
Of the 133 persons with acute insecticide-related
illness associated with mosquito control, 35 (26.3%) were identified from
monitoring media reports (including 34 reported subsequently by health-care
providers), 32 (24.1%) were reported by poison-control centers, 27 (20.3%)
were self-reported, and seven (5.3%) were reported by state health departments.
Physicians and EDs were responsible for initial reporting of five and three
cases, respectively. The remaining cases were reported initially by friends
or relatives (n = seven), government agencies (n = five), employers (n =
four), laboratories (n = two), and other sources (n = six).
Of the 85 persons with reported illness who were known
to have sought medical care, 45 (52.9%) were treated in EDs, 35 (41.2%)
were treated in physicians' offices, four (4.7%) were treated in employee
health centers, and one (1.2%) was hospitalized. An additional 16 persons
received advice from a poison-control center, and 15 did not seek medical
care; information about medical treatment was not available for 17 persons.
Of the 133 reported cases of pesticide-related illness,
95 (71.4%) cases were associated with organophosphates, primarily malathion.
Malathion alone was associated with 64 (67.4%) of the 95 cases; 37 (27.8%)
cases were associated with pyrethoids, primarily sumithrin (24 cases)
and resmethrin (10 cases).
Illness severity was categorized for all cases.
One exposure was associated with illness of high severity.
When her neighborhood was sprayed, a woman aged 54 years was exposed
to sumithrin, which passed through operating window fans and a window
air conditioner. She had exacerbation of her asthma and chronic obstructive
pulmonary disease. The majority of the remaining cases were of low
(65.4%) or moderate (33.8%) severity.
The majority of cases were associated either with
respiratory (66.2%) or neurologic (60.9%) dysfunction. Other systems affected
were gastrointestinal (45.1%), ocular (36.1%), dermal (27.1%), cardiovascular
(12.0%), renal-genitourinary (3.0%), and miscellaneous (28.6%).
Of 36 persons who were exposed at their workplaces,
14 (38.9%) were insecticide applicators, and 22 (61.1%) were performing
tasks that did not involve pesticide application. Seven (50.0%) of 14
applicators were exposed to sumithrin; of the other 22 workers, 11 (50%)
were exposed to malathion, and five (22.7%) were exposed to resmethrin.
Illness of moderate severity was more frequent among applicators (42.9%)
than nonapplicators (27.3%).
Editorial Note: The findings in this report indicate that serious
adverse outcomes potentially related to public health insecticide application
were uncommon.
When administered properly in a mosquito-control program,
insecticides pose a low risk for acute, temporary health effects among
persons in areas that are being sprayed and among workers handling and
applying insecticides. In this analysis, adverse health effects were
identified in a small percentage of the population in the nine states.
Malathion, naled, sumithrin, and resmethrin were associated with the
majority of reported cases of acute insecticide-related illness. Malathion
is an organophosphate insecticide that is classified as an acute toxicity
category III compound*. Although it is less acutely toxic than many other
organophosphates, adverse health effects have been reported by exposed
persons. Naled is an acute toxicity level I organophosphate. When combined
with piperonyl butoxide, resmethrin and sumithrin are highly effective
insecticides that are of low-order toxicity to mammals, including humans;
these pyrethroid products are classified as acute toxicity category III
compounds and have been associated with adverse health effects in humans.
(* The U.S. Environmental Protection Agency classifies
pesticide products into one of four acute toxicity categories on the basis
of certain criteria, with category I comprising pesticides with the greatest
toxicity and category IV those with the least toxicity. )
These insecticide formulations are registered by the U.S. Environmental
Protection Agency for use in urban areas for mosquito control and benefit
the public by controlling populations of mosquitoes that transmit diseases
that affect humans. Reported symptoms associated with these insecticides
were temporary and included dermal, ocular, and upper and lower respiratory
tract irritation and exacerbation of conditions such as asthma. These health
effects might represent irritant or allergic responses, to either the insecticide
or its carrier. Anxiety about insecticide use for mosquito control also
might have been responsible for symptoms in some persons.
To reduce potential risks from insecticide exposure, CDC recommends the
use of integrated pest management strategies for mosquito-control programs
that emphasize mosquito larval control, reduction of breeding sites (e.g.,
human-made collections of stagnant water such as unchlorinated swimming pools,
discarded tires or other containers, and bird baths), and judicious use
of insecticides to control adult mosquito populations when quantitative measures
suggest an elevated risk for human infection or in community settings when
extensive immature mosquito larval habitats cannot be controlled. When insecticides
are used, public health agencies should inform the public when and where
spraying will occur and communicate how to reduce the likelihood of exposure.
To avoid direct exposure from passing spray trucks, public health agencies
should ensure that visible and audible warnings are made before spraying.
Persons with exposure-related health concerns should consult their health-care
providers. To prevent exposures from improper application methods, insecticide
handlers and applicators should be trained in proper insecticide handling
and application methods and in the use of appropriate personal protective
equipment.
REF: CDC, Morbidity and Mortality Weekly Report,
July 11, 2003 / 52(27);629-634.
TOXICOLOGY TIDBITS
The Memorial Sloan-Kettering Cancer Center has posted
a
free database with
more than 300 entries about herbs, dietary supplements, and "alternative"
cancer treatments. The entries contain a clinical summary for each agent
and provides details about constituents, adverse effects, interactions,
and potential benefits or problems. Both "professional" and consumer
versions are provided, but most of the professional information is readily
understandable by laypersons.
REF: www.mskcc.org
Website Offers
Information, Insight on Foodborne Illnesses
If you find yourself suffering from what you think
is a foodborne illness, there's a Website that can not only offer you
some help, but also help health officials determine if there is a public
health problem to consider. Whether it's potato salad left out in the
sun, hamburger that has seen better days, or a steak that wasn't cooked
enough, a long holiday weekend can create some gastrointestinal problems
if you're not careful.
Developed by the Michigan State University National
Food Safety and Toxicology Center (NFSTC), the Web site is at
http://www.RUSick2.msu.edu. People
who are experiencing sudden vomiting and diarrhea -- strong symptoms of
food poisoning -- can go to the Website to see if others have reported
eating the same foods or are experiencing the same symptoms.
Believed to be the first of its kind in the nation,
the Website allows users to fill out an online survey to determine how
many other forum users with the same symptoms ate the same foods from
the same source at the same time. The survey has been adapted to
take as long as the visitor wishes -- he or she can enter just symptoms,
or continue and enter a food history, and maybe even food sources, if time
permits.
Originally launched in November 2002, the Website was
designed to detect clusters of suspected food poisoning cases in Michigan's
Ingham, Eaton and Clinton counties. Since then, the site has expanded its
scope.
Symptoms of foodborne illness can include nausea, diarrhea
and abdominal cramps. Stomach and abdominal pain, cramps and spasms are
the No. 1 reason people go to a hospital emergency room or urgent care
clinic.
There are an estimated 76 million foodborne illnesses
and as many as 5,000 deaths every year in the United States, according
to the Centers for Disease Control and Prevention.
REF: FSnet June 30/03.
ATSDR Toxprofiles 2003TM
Cd-Rom
The Agency for Toxic Substances and Disease Registry
(ATSDR) announces its release of the ATSDR ToxProfiles 2003
TM
CD-ROM, featuring updated toxicologic information and new navigational
tools that allow the user to quickly hyperlink to important topics within
the CD-ROM.
The information in the ATSDR ToxProfiles 2003
TM
CD-ROM focuses on health effects from exposure to specific hazardous
substances, as well as other toxicologic and epidemiologic information.
Each profile is peer-reviewed and includes an easy-to-read section on
public health information in non-technical language.
The CD-ROM contains 161 toxicological profiles and
nine interaction profiles, that cover more than 250 total substances
and makes toxicological information more accessible and convenient for
health care workers, toxicologists, occupational health physicians, public
health personnel, communities, and ATSDR's environmental health partners.
The ATSDR ToxProfiles 2003
TM
CD-ROM includes:
- Five draft profiles, including three updated profiles, ammonia, copper,
PBBs/PBDEs (polybrominated biphenyls/polybrominated diphenyl ethers)
and two new profiles, chlorine dioxide and synthetic vitreous fibers.
- Seven finalized profiles that were previously "draft for
public comment" profiles, aldrin/dieldrin, beryllium, creosote, DDT,
DEHP (di (2-ethylhexyl) phthalate), hexachlorobenzene and methoxychlor.
The profiles also are accessible on the ATSDR
Web site at
www.atsdr.cdc.gov
REF: ATSDR announcement, June 3, 2003.
EPA Finalizes Voluntary Cancellation
of Virtually All Residential Uses of CCA-Treated Wood
On March 17, EPA granted the voluntary cancellation
and use termination requests affecting virtually all residential uses
of chromated copper arsenate (CCA) treated wood. Under this action,
affected CCA products cannot be used after Dec. 30, 2003 to treat lumber
intended for use in most residential settings. This transition affects
virtually all residential uses of wood treated with CCA, including play
structures, decks, picnic tables, landscaping timbers, residential fencing,
patios and walkways/boardwalks. This action was proposed in February 2002
by the registrants of CCA-pesticide products used to treat wood.
Phase-out of the residential uses will reduce
the potential exposure risks to arsenic, a known human carcinogen,
thereby protecting human health, especially children's health and
the environment. The current action follows up on the February 2002
publication of a notice of receipt of voluntary cancellation/use termination
requests, which also provided an opportunity for public comments to be
submitted to EPA. A notice of the cancellation order will be published in
the
Federal Register, and that document will include the Agency's
response to comments. Consumers may continue to buy and use the treated
CCA wood for as long as it is available. The transition to using the new
generation treatment products is well underway.
The Agency is deferring
any action on two uses involved in the termination requests, therefore wood
used in permanent wood foundations and fence posts for agricultural uses
may continue to be treated with CCA at this time. EPA is working with
the registrant community and other stakeholders to ensure that safer, comparable
alternatives will be available. EPA is continuing its work on an ongoing
comprehensive reevaluation of CCA-treated wood that has been underway
as part of the Agency's effort to reevaluate older pesticides to ensure
that they meet current health and safety standards. More information on
CCA treated wood is available at:
http://www.epa.gov/pesticides/factsheets/chemicals/1file.htm
REF:
EPA OPP
Press Release.
Snakes Beware 
The EPA has granted a registration to the Animal and
Plant Health Inspection Service (APHIS) for the new active ingredient
acetaminophen, to be used to control the invasive brown tree snake in
Guam and the Commonwealth of the Northern Marianas Islands. The brown
tree snake, a species that originated in New Guinea, is a significant
and invasive exotic pest that was introduced on Guam during World War
II, presumably by military transport. Native wildlife on Guam and the
Marianas Islands have been under severe predation pressure by this pest
for years. If the brown tree snake were to reach Hawaii or enter the
continental United States, the potential for damage by this invasive species
is high. Since the early 1990s, the Department of Defense has spent over
$1 million yearly to combat the brown tree snake and prevent its movement
to other locations. The brown tree snake is also responsible for numerous
power outages in Guam, deaths of pets, and bites (venomous) of humans,
especially infants. Research and use of acetaminophen under quarantine
exemptions has shown excellent results in reducing brown tree snake populations,
with consumption of only one baited mouse needed to kill a brown tree
snake.
REF: (EPA
OPP Pesticide Program Update).
Safe Swimming
Swimming, one of the most popular activities
in the country, is a fun, active, and healthy way to spend leisure
time. Every year, millions of people visit “recreational water” sites,
such as swimming pools, water parks, hot tubs, lakes, rivers, or the
ocean.
Over the past century, the use of modern disinfection
systems in pools and environmental improvements in our lakes, rivers,
and oceans has improved the quality of recreational water. Despite this,
there has been an increase over the past decade in the number of outbreaks
of illness associated with swimming.
This Website
Healthy Swimming provides
information for swimmers, pool operators, and public health professionals
to improve the swimming experience by raising awareness about the spread
of recreational water illnesses (RWIs). Practicing "Healthy Swimming"
behaviors should reduce the risk of getting ill.
REF: Centers for Disease Control website.
FDA'S Response to Food, Dietary Supplement, and Cosmetic Adverse
Events
A child's throat swells up after she eats a piece
of fruit. A man gets short of breath after he takes a dietary supplement.
A woman gets an eye infection after she uses mascara. Are these allergic
reactions? Effects of chemical properties or contaminants? Or just coincidences?
Determining the cause of incidents like these and helping to prevent
their recurrence is the focus of a new system within the Food and Drug
Administration's Center for Food Safety and Applied Nutrition (CFSAN).
The center is launching its CFSAN Adverse Event Reporting
System (CAERS) to help track and monitor adverse events related to foods,
dietary supplements, cosmetics, food additives, and color additives --
the five types of products regulated by CFSAN.
An adverse event is any illness or injury that may
be associated with a product or ingredient. Adverse event reporting systems
typically detect only a small proportion of the events that actually
occur, according to an April 2001 report from the Health and Human Services
Office of Inspector General. For example, according to one estimate,
the FDA receives reports of less than 1 percent of all adverse events associated
with dietary supplements.
Consumers can play an important public health role
by reporting to the Food and Drug Administration any adverse events or
other problems with FDA-regulated products. Timely reporting allows the
agency to take prompt action. Report what happened as soon as possible.
Have the following information ready:
- Description of the adverse event
- Name, address, and phone number of the doctor or hospital if emergency
treatment was provided
- Name of product and manufacturer
- Any codes or identifying marks on the product label or container
- Name and address of the store where you purchased the product and
the date of purchase.
To report an emergency that requires immediate action,
such as a case of foodborne illness or a drug product that has been tampered
with, call the FDA's main emergency number, staffed 24 hours a day: 301-443-1240.
To report a non-emergency adverse event, contact the
FDA district office nearest you. Look up the FDA's phone number under the
Department of Health and Human Services in the blue U.S. government section
of the telephone directory. Or check the phone numbers listed by state
at
www.fda.gov/opacom/backgrounders/complain.html.
Adverse events regarding medical products may also
be reported to the FDA's MedWatch program at 1-800-FDA-1088 (1-800-332-1088)
or
www.fda.gov/medwatch.
Also report the problem to the manufacturer or distributor
shown on the product label and to the store where you purchased the product.
REF: FDA Consumer
magazine, July-August 2003 Issue.
National Pesticide
Information Center Brochure Available
The National Pesticide Information Center (NPIC),
the toll-free pesticide information help line co-sponsored by EPA and Oregon
State University, recently released its newly designed free brochure for
distribution to the general public. The brochure contains important information
about
NPIC and its valuable, free
services. EPA has a limited number of copies available. If you would like
a copy call 1-703-305-5017; for more than 10 copies, contact NPIC at: 1-800-858-7378;
email: npic@ce.orst.edu.
REF: Pesticides Notes, June/July 2003.
Nationwide Campaign to Protect Children
In an effort to protect children from poisons, clinics,
health department and hospitals around the country will begin receiving
display posters urging consumers to store pesticides and other household
chemicals up high in a locked cabinet. Storing pesticides and other chemicals
out of children's reach, up high in a locked cabinet, can be a simple but
effective means of poison prevention. For possible poisonings, consumers
should immediately call the poison center at 1-800-222-1222. To view a copy
of the poster, go to:
http://www.epa.gov/oppfead1/cb/csb_page/publications/lockitup-poster.pdf.
REF: Pesticides Notes, June/July 2003.
EPA'S FY 2002 Annual Report
Available
Promoting Safety for America's Future, the Fiscal
Year 2002 Pesticide Program Annual Report is now available at:
http://www.epa.gov/oppfead1/annual/.
The report summarizes the Agency's testing requirements, reassessment of
older products, strong partnerships with stakeholders, and outreach and
communication efforts with the public. Highlights include the following:
- Registration of new active ingredients
- Registration of new uses
- Risk management decisions
- Increased communication with the public
- Stepping up Integrated Pest Management in schools
REF: Pesticides Notes, June/July 2003.
Household Products Database
The National Institutes of Health announced a consumer's
guide that provides easy-to-understand information on the potential health
effects of more than 2,000 ingredients contained in more than 4,000 common
household products.
Some household products contain substances that can
pose health risks if they are ingested or inhaled, or if they come in
contact with eyes and skin. The National Library of Medicine's (NLM) Household
Products Database (
http://householdproducts.nlm.nih.gov)
provides information in consumer friendly language on many of these substances
and their potential health effects. For more technical information users
can launch a search for a product or ingredient in TOXNET from the Product
Page in the database.
"The Household Products Database is a natural outgrowth of the work
that the Library has done in recent years, educating the public about environmental
risks posed by chemicals in the air, soil and water," explained NLM Director
Dr. Donald A.B. Lindberg. "Last year, we unveiled Tox Town (
http://toxtown.nlm.nih.gov), a site
that introduces consumers to the toxic chemicals and environmental risks
they might encounter in everyday life, in everyday places. Tox Town looks
at facilities like schools, office buildings and factories, and the chemicals
likely to be in them. With the Household Products site, we go inside the
user's home and provide information about common products and their potential
health effects."
The Household Products Database enables users to learn
what's in the products under the kitchen sink, in the garage, in the bathroom,
and on the laundry room shelf. It is designed to help answer questions
such as:
- What chemicals are contained in specific brands and in what percentage?
- Which products contain specified chemicals?
- Who manufactures a specific brand? How can I contact the manufacturer?
- What are the potential health effects of the chemical ingredients
in a specific brand?
- What other information is available about such chemicals in the
toxicology- related databases of the National Library of Medicine? For
example, a homeowner trying to decide which algae-killing product to use
in her swimming pool could select the "Landscape/Yard/Swimming Pool" category
in Household Products and click on "algaecide." She then could choose several
brands to examine for chemical content and possible health hazards. The
record for each product would show her the ingredients from something called
the Material Safety Data Sheet (MSDS). Designed to provide workers and
emergency personnel with the proper procedures for handling or working
with a particular substance, these sheets are produced by the manufacturer
of the product as required by Federal law.
REF: National Institutes of Health National Library
of Medicine Release, August 1, 2003.
FDA Pesticide Program: Residue Monitoring: 1993-2001
This document is the fifteenth annual report
summarizing the results of the
Food and Drug Administration's
(FDA) Pesticide Residue Monitoring Program. This report includes findings
obtained during FY 2001 (October 1, 2000 through September 30, 2001) under
regulatory and incidence/level monitoring. Selected Total Diet Study findings
for 2001 are also presented. Results in these reports continue to demonstrate
that
levels of pesticide residues in the U.S. food supply are
well below established safety standards.
REF: EdNet Update, May 2003
What Would You List as the Top Seven Concerns for Food Safety?
What would you list as the top seven concerns
for food safety? According to an Ohio State University study, the top seven
perceived safety risks (in order of concern): pesticide residues, drinking
water contamination, growth hormones in meat or milk, bacterial contamination,
bioterrorism, mad cow disease, and biotech foods. Additionally, consumers
who are regularly exposed to print, radio, or television news are more
likely to have concerns about food safety.
(CropLife
America Spotlight, 6-20-03 via Chemically Speaking, 7-03). Which
of the perceived food risks actually causes the greatest risk? Bacterial
contamination probably outweighs all of the other risks combined.
REF: Georgia Pest Management Newsletter, August
2003/Volume 26, No. 8.
Pesticide Development Time Lines and
Dollars
CropLife America and the European Crop Protection
Association released results of a study that shows that the average discovery,
development and registration costs to bring a crop protection product to
market have increased from $152 million in 1995 to $184 million in 2000,
a cost eight times higher than 20 years ago. The consulting firm conducting
the study attributed the increase primarily to the adoption of new technology,
stricter regulatory standards instituted to ensure environmental and consumer
protection, and a rise in the amount of data required by regulatory authorities.
Also, the development period for a new product (from first synthesis to commercialization)
has increased from 8.3 years in 1995 to 9.1 years in 2000, and the average
number of molecules screened leading to the introduction of each new product
increased from 52,500 to >139,000 for these same respective years.
(CropLife America Spotlight via Chemically Speaking, June
2003, University of Florida)
REF: The Label, July 2003 Vol. 15 , No. 7.
VETERINARY NOTES
USP Closes Its Veterinary
Practitioners' Reporting Program
The United States Pharmacopeia (USP)
has decided to close its Veterinary Practitioners' Reporting Program
(VPRP) after nine years of operation. The program, which closed
on April 30, 2003, was created to identify and ultimately correct adverse
reactions with drugs, biologics, and insecticides administered to domestic
animals.
"Regretfully, we decided to discontinue the VPRP.
We believe that as an organization, USP should focus our efforts on
other initiatives, such as setting quality standards for veterinary
preparations," said Roger L. Williams, M.D., executive vice president
and chief executive officer of USP. "Our greatest contributions
to the veterinary community have been and will continue to be made through
our standards-setting activities."
USP started VPRP in collaboration
with the American Veterinary Medical Association (AVMA) in response
to the growing need by animal owners, veterinary practitioners, and
regulatory agencies for a system to collect and release data on adverse
veterinary-product experiences. Since the program's inception in
1994, USP has received more than 5,000 reports.
A key component of the VPRP was USP's
notification process for submitted reports. With the consent of
the reporter, USP would notify AVMA, the manufacturer of the product,
and the appropriate regulatory agency of each adverse report submitted.
If a cluster of reports was received for a single product, the appropriate
regulatory agency could then pursue an investigation. The government
agencies involved were: the U.S. Food and Drug Administration's (FDA)
Center for Veterinary Medicine (CVM), the U.S. Environmental Protection
Agency (EPA), and the Center for Veterinary Biologics (CVB) -- a
unit of the U.S. Department of Agriculture (USDA).
USP recommends that participants of the VPRP direct future
adverse reports to the following regulatory agencies:
- CVM -- for adverse drug experiences. You may submit
a report by telephoning CVM at 1-888-FDA-VETS. You can also
obtain an adverse reporting form on the organization's Web site at
www.fda.gov/cvm.
- CVB -- for veterinary biologics, such as vaccines and
bacterins. Visit the link: www.aphis.usda.gov
to obtain a form, or call CVB at 1-800-752-6255.
For further information on the closing of the Veterinary
Practitioners' Reporting Program, please send an e-mail to mediarelations@usp.org.
REF: USP News Release www.usp.org,
May 9, 2003.
New CDC Web Site for Animal/Human Health Risks
The following article is used with permission,
and provides information about human health risks related to animals.
Veterinarians may wish to duplicate this article and provide copies
to their interested clients. As always, material that appears in the
FDA Veterinarian is free of copyright and may be reproduced without permission.
The U.S. Centers for Disease Control and Prevention
(CDC) has created a website to provide people with information about
the health-related risks of owning and caring for animals. Links are
located throughout the website for general information about companion
and wild animals and the diseases they could carry. The website offers
important information about safe practices for handling domestic animals
and avoiding wild ones. The
Healthy
Pets, Healthy People web site is online at www.cdc.gov/healthypets.
REF: FDA Veterinarian, Vol. XVIII,
No. III, May/June 2003.
Think Twice Before Using Gentamicin
No one was thinking about drug residues when
they treated several hundred head of sick young calves that had just
traveled hundreds of miles from dairy farms in Idaho and Washington.
They were just trying to keep them alive and save their sight, because
many were scouring and suffering with severe pinkeye. Using gentamicin
under a veterinarian’s direction seemed to be the most effective treatment
when given orally to treat the scours and used as a flush in the calves’
eyes. The calves recovered and in another two months were in good enough
shape to be shipped out to feedlots.
Another year would pass before the calves had
grown and reached market weight. No one was thinking about drug residues
when the calves, now grown to steers, were shipped for slaughter, because
no one had treated them at the feedlot. Sampling by USDA at the slaughter
plant changed everyone’s thinking when a gentamicin residue was found
in the kidney of the steer sampled.
There is
no “tolerance” for gentamicin in
cattle, because a gentamicin-containing drug has not been approved
for use in cattle. Gentamicin is known to bind to the kidney tissue
of cattle irregardless of the route of administration and could be a
residue concern for 18 months or more. In fact,
no withdrawal period
has been scientifically established in cattle for those veterinarians
searching the literature for direction in an “extra-label” use scenario.
No one thought about a drug being sustained in an animal for a year or
more, but gentamicin is different and professionals treating cattle need
to know this. In this investigation, veterinarians involved in treating
the calves recommended a six-month withdrawal period and their colleagues
were their source of the withdrawal period. There was a learning experience
from this investigation for the professionals involved when they were
informed of the unusual residue problems with gentamicin, and subsequently
stopped using it in dairy and feedlot cattle.
CVM’s Dr. Mike Talley notes that “veterinarians
and producers should be aware that there are approved drugs to treat
the conditions described in calves that have much less potential for prolonged
residues available for extra-label use if the approved drugs were found
not to be effective by the prescribing veterinarian. In addition, the
American Association of Bovine Practitioners (AABP), the American Veterinary
Medical Association (AVMA), and the Academy of Veterinary Consultants
have position papers or resolutions saying that
aminoglycosides should
not be used for extra-label purposes in cattle.”
REF: FDA Veterinarian, Vol. XVIII,
No. III, May/June 2003.
Environmental Exposure Report
Nationwide Campaign to Protect Children
VETERINARY NOTES
~~~ NOTE FROM THE EDITOR ~~~
