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I'm Young Lee from the Office of Food Safety,
FDA's Center for Food Safety and Applied Nutrition.
Our center oversees all the issues
related to the FDA's pesticide program in food.
In this presentation, we are going to discuss
FDA's Pesticide Residue Monitoring Program in food
in regards to FDA's authority and responsibilities.
The responsibility for the regulation of pesticides
is shared by three federal government agencies --
EPA, FDA, and USDA.
Under the FIFRA,
Federal Insecticide, Fungicide, and Rodenticide Act,
all pesticides must be registered with the EPA
before they may be sold or distributed in U.S. commerce.
FIFRA sets an overall risk/benefit standard
for pesticide registration
requiring that pesticides that perform their intended function
when used according to labeling directions
without posing unreasonable risks of adverse effects
on human health or the environment.
EPA is also responsible under the Federal Food, Drug, and Cosmetic Act
for establishing the tolerance
if use of a pesticide may result in residues in or on food.
The responsibility of FDA in the regulation of pesticides
is to enforce tolerances established by EPA in foods and feeds,
except for meat, poultry, and certain egg products,
for which the USDA is responsible to enforce EPA tolerances.
FDA's Center for Food Safety and Applied Nutrition
is charged with enforcing U.S. tolerances in foods,
and the Center for Veterinary Medicine
directs monitoring fees for pesticide residues.
I would also like to note
that USDA's agricultural marketing service
has carried out the Pesticide Data Program for EPA
that is primarily used
to assess dietary exposures to pesticide residues.
FDA's Pesticide Residue Monitoring Program
consists of three approaches --
Regulatory Monitoring,
Incidence/Level Monitoring,
and the Total Diet Study.
Regulatory Monitoring is used to enforce the tolerances
in both imported and domestically produced foods.
The goal of the Regulatory Monitoring Program
is to carry out selective monitoring
to achieve an adequate level of consumer protection.
The second approach is the Incidence/Level Monitoring,
which is a complementary approach
to our Regulatory Monitoring Program.
This approach is to increase FDA's knowledge
about particular pesticide commodity combinations.
The third approach is the Total Diet Study.
It is another major element
of FDA's Pesticide Residue Monitoring Program.
It is also known as the Market Basket Study.
First, we'll discuss the Regulatory Monitoring approach,
which is to enforce the tolerances.
Under this approach, domestic samples are collected
as close as possible to the point of production
in the distribution system.
They are collected at the farm, packers, or distributors.
Import samples are collected at the point of entry into U.S. commerce.
The emphasis of the program is on raw agricultural commodities,
which are analyzed as unwashed, whole, unpeeled, raw commodities.
However, some processed foods are also included.
The program also focuses on foods consumed by infants and children.
FDA currently analyzes about 5,000 to 7,000 food samples per year
for pesticide residues
under this Regulatory Monitoring approach.
To analyze the larger number of samples
whose pesticide treatment history is usually unknown,
FDA uses multi-residue methods
capable of simultaneously determining
a number of pesticide residues.
These multi-residue methods can determine
about half of the approximately 400 pesticides with EPA tolerances
and many others that have no tolerances.
The most commonly used multi-residue methods
can also detect many metabolites, impurities,
and alteration products of pesticides.
FDA also uses selective multi-residue methods
and single-residue methods to determine some pesticide residues
which cannot be determined by the multi-residue methods.
More than 450 pesticides are detectable
by the methods currently used in our Regulatory Monitoring Program.
Shipments containing illegal residues are considered as violative.
Illegal residues are defined
as "a residue which exceeds an EPA tolerance
for that particular food
or a residue for which no EPA tolerances has been established
for that particular food-pesticide combination."
In the case of domestic food found adulterated with a pesticide residue,
FDA can invoke various sanctions
such as seizure or injunction from commercial channels of trade.
However, in practice,
it is seldom necessary for FDA to initiate such a formal action.
In many cases, violative shipments are destroyed voluntarily
by a responsible party
or voluntary recalled if they have already been distributed.
States also will embargo an adulterated food commodity
if it still remains in the field.
For imports, shipments may be stopped at the port of entry
when illegal residues are found.
If there is reason to believe
that the same situation will exist in future lots
during the same shipping season
for a specific shipper, grower, geographic area, or country,
detention without physical examination may be invoked
based on the finding of even one violative shipment.
The information
about the current detentions without physical examination
is available at FDA's Import Alert website.
You can view them by geographic area or country, by industry,
or by import-alert numbers.
This is a list of import-alert numbers
for the shipments detained without physical examination
due to illegal pesticide residues.
FDA establishes monitoring priorities
through development of an annual national sampling plan,
which is a compilation of regional sampling plans
prepared by FDA personnel throughout the United States.
Factors considered by FDA in planning the types
and numbers of samples to collect
include review of recently generated state and FDA residue data,
regional intelligence on pesticide usage information,
dietary importance of food,
foods consumed by infants and children,
information on the amount of food entering in commerce,
as well as chemical characteristics and toxicity of pesticides.
This slide shows the number of samples FDA has collected
for pesticide residues
under the Regulatory Monitoring Program
for the past 20 years.
Currently, we collect about 5,000 to 7,000 regulatory samples per year
for pesticide residues.
This slide shows the violation rates due to illegal pesticide residues
for domestic and imported samples over the past 20 years.
It ranges from 1% to 2% for domestic samples.
For import samples, it varies from 2% to 5% each year.
This is a summary of the results
from the fiscal year 2008 Regulatory Monitoring Program.
In fiscal year 2008,
FDA collected and analyzed about 5,000 samples --
1,400 domestic and 3,600 imported samples.
About 470 pesticides were detectable by the methods used in the program.
More than 64% of domestic
and over 72% of imported samples that were analyzed
contained no residues.
The violation rate was less than 1% for domestic,
and for imports, less than 5% of the samples we analyzed.
This slide shows the results of FDA's analysis
of 2008 domestic samples by Commodity Group.
As in earlier years,
fruits and vegetables accounted for the largest proportion
of the domestic commodities,
comprising approximately 75% of the domestic samples analyzed
for the pesticide residues.
This slide shows the results of 2008 import samples by commodity group.
As for the domestic samples
that we collected and analyzed for the pesticide residues,
fruits and vegetables also accounted
for the largest proportion of the import samples,
accounting for more than 71% of the import samples analyzed.
Our annual report and detailed information
on our regulatory residue monitoring data
are available at the fda.gov website.
Now we'll discuss the Incidence/Level Monitoring Program.
It is a complementary approach to our Regulatory Monitoring Program
to increase our knowledge
about particular pesticide-commodity combinations
by analyzing certain food items
to determine the presence and level of selected pesticides.
This is a list of the surveys FDA has conducted for the past 20 years
under this Incidence and Level Monitoring approach.
We have often been asked
whether our Regulatory Monitoring Program is statistically based.
Therefore, we will discuss briefly
the statistically based monitoring surveys
that FDA has conducted in the '90s
under the Incidence/Level Monitoring approach.
Most of the FDA's sampling of the food supply for pesticide residues
is random,
but bias is incurred by emphasizing sampling
based on known problem areas,
as well as suspected problem areas.
The data generated from our Regulatory Monitoring Program
are therefore not necessarily statistically representative
of the general residue situation.
As part of the agency's continuing effort
to expand the scope of its Pesticide Residue Monitoring Program,
in 1992, FDA initiated statistically based monitoring surveys
under the Incidence/Level Monitoring approach.
The objective was how violation rates, frequency of occurrence,
and residue levels obtained from a statistically based sampling
differ from those obtained
through our traditional Regulatory Monitoring Program.
These studies targeted high-consumption foods,
especially those that comprise
a major part of the diet of infants and children.
For these surveys, four commodities were selected --
tomatoes, pears, apples, and rice --
because they are widely consumed, available year-round,
and consumed raw, except rice.
In view of resource constraints
and in order to achieve an acceptable level of precision,
a target of 800 was chosen as a practical number of samples
for each set of domestic and imports.
Although there may be specific differences
between results obtained from our Regulatory Monitoring Program
and statistically based monitoring of those four commodities,
overall, these statistically based surveys
corroborated the low levels of pesticide residues
found in FDA's Regulatory Monitoring
and demonstrated that FDA's Regulatory Monitoring
provides a reasonably reliable estimate of pesticide residues
in the U.S. food supply.
We'll now discuss the Total Diet Study,
which is another major element
of the FDA's Pesticide Residue Monitoring Program.
The Total Diet Study is also known as the Market Basket Study.
It is a yearly program initiated by FDA in 1961.
The objectives of the Total Diet Study
are to determine levels of various pesticide residues
and to provide estimates of dietary exposure
to pesticide residues
for specific age/sex groups of the U.S. population.
It also identifies trends and changes
in the levels in the U.S. food supply and in their diets.
In addition to pesticide chemicals,
the Total Diet Study also monitors toxic and nutrient elements,
radionuclides, and industrial chemicals.
The foods in the Total Diet Study
are selected on the basis of the National Food Consumption Surveys
to represent the main foods consumed by the U.S. population.
The current program was implemented in 2003
and includes about 280 food items
that represent the average diet eaten by U.S. population.
The list of the Total Diet Study foods is updated from time to time
to reflect changing eating patterns in the United States.
Foods are analyzed as they would be consumed.
The analytical methods used in the Total Diet Study
are modified to permit measurement at levels 10 to 100 times lower
than those normally used in our Regulatory Monitoring.
Residue levels as low as .1 parts per billion
are routinely reported in the Total Diet Study.
The food items included in the Total Diet Study
can estimate dietary exposure of 14 different age/sex groups,
ranging from 6- to 11-month infants
to 70-plus-year-old males and females.
For the Total Diet Study,
foods are collected four times every year,
once in each of the four geographic regions of the United States --
West, North Central,
Northeast, and South.
For each Market Basket,
foods are purchased by FDA personnel from supermarkets,
local grocery stores, and fast-food restaurants
to represent a different geographic region.
Each Market Basket is a composite of foods collected in three cities
in a particular region.
The cities selected in a geographical area vary from year to year.
Selected cities are usually in a standard metropolitan statistical area
close to FDA districts or field offices.
The foods are shipped to the FDA's Kansas City district laboratory,
where the foods are prepared table-ready
and analyzed as consumed for pesticide residues.
More than 300 pesticide chemicals can be determined
by the methods used in the Total Diet Study.
In general, about 100 different pesticides
are found in each Market Basket.
Residue information obtained through the Total Diet Study
is used to estimate dietary intakes of pesticides.
These intakes are then compared with established standards,
FAO/WHO's acceptable daily intake
and EPA's reference dose.
The estimated dietary intakes of pesticides
based on the Total Diet Study
have been well below FAO/WHO's acceptable daily intakes
and EPA's reference doses.
They have rarely exceeded 1% of the acceptable daily intakes.
FDA participates in several international cooperative agreements
in an effort to minimize incidents of violative residues
and remove trade barriers.
Under the pesticide program,
three foreign governments have currently entered
into cooperative agreements with FDA --
The Residue Assurance Compliance Programme
with the New Zealand Food Safety Authority,
Action Plan on Food Safety with the Canadian Food Inspection Agency,
and collaboration with the Spanish government.
Although the specifications of these agreements differ in each case,
the main purpose is to facilitate the entry of produces
into the United States
by providing FDA and official assurance
from the foreign governments
that the produce covered by the agreement
will comply with the U.S. entry regulations
covering pesticide residues.
In this presentation,
we have given you a brief overview of FDA's pesticide program
with emphasis on FDA's authority and responsibility.
Our website, www.fda.gov,
also includes useful information
on FDA's Residue Monitoring Program,
a summary and detailed analysis of the residue data
from our Regulatory Monitoring Program
and from the Total Diet Study,
the glossary of pesticide chemicals,
pesticide analytical behavior data,
and the pesticide analytical manuals.
We encourage you
to check the website frequently for new information.