Pesticides on Tobacco
Federal Activities to Assess Risks and Monitor Residues Gao ID: GAO-03-485 March 26, 2003Pesticides play a significant role in increasing production of tobacco, food, and other crops by reducing the number of crop-destroying pests. However, if used improperly, pesticides can have significant adverse health effects. GAO was asked to (1) identify the pesticides commonly used on tobacco crops and the potential health risks associated with them, (2) determine how the Environmental Protection Agency (EPA) assesses and mitigates health risks associated with pesticides used on tobacco, and (3) assess the extent to which federal agencies regulate and test for pesticide residues on tobacco.
In the 1990s, domestic growers commonly used 37 pesticides approved for use on tobacco by EPA. Most of these pesticides were also used on food crops. When used in ways that deviate from conditions set by EPA, many of these pesticides can cause moderate to severe respiratory and neurological damage--and may result in death. Moreover, animal studies suggest that some of these pesticides may cause birth defects or cancer. Under its pesticide registration program, EPA evaluates toxicity and other data to assess health risks to workers and the public from exposure to pesticides--and risks to smokers from exposure to residues in smoke. These assessments have identified a range of risks that required such mitigation as limiting where and how the pesticide may be used, prohibiting use in certain states, and requiring workers to wear respirators and chemical-resistant clothing. On the other hand, EPA has concluded that low levels of residues in tobacco smoke do not pose short-term health concerns requiring mitigation. EPA does not assess intermediate or long-term risks to smokers because of the severity of health effects linked to use of tobacco products themselves. While EPA regulates the specific pesticides that may be used on tobacco and other crops and specifies how the pesticides may be used, it does not otherwise regulate residues of pesticides approved for use on tobacco. The U.S. Department of Agriculture (USDA), however, is required by the Dairy and Tobacco Adjustment Act to test imported and domestic tobacco for residues of pesticides not approved by EPA for use on tobacco that federal officials believe are used in other countries. By helping ensure that other countries do not use highly toxic pesticides that U.S. tobacco growers may not use, federal regulation of pesticide residues on tobacco addresses trade equity as well as health and environmental issues. However, USDA has not reevaluated the list of pesticides for which it tests since 1989, even though EPA has cancelled tobacco use for over 30 pesticides since then.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Team: Phone:GAO-03-485, Pesticides on Tobacco: Federal Activities to Assess Risks and Monitor Residues
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Report to the Ranking Minority Member, Committee on Government Reform,
House of Representatives:
United States General Accounting Office:
GAO:
March 2003:
Pesticides on Tobacco:
Federal Activities to Assess Risks and Monitor Residues:
GAO-03-485:
GAO Highlights:
Highlights of GAO-03-485, a report to the Ranking Minority Member,
Committee on Government Reform, House of Representatives
Why GAO Did This Study:
Pesticides play a significant role in increasing production of tobacco,
food, and other crops by reducing the number of crop-destroying pests.
However, if used improperly, pesticides can have significant adverse
health effects. GAO was asked to (1) identify the pesticides commonly
used on tobacco crops and the potential health risks associated with
them, (2) determine how the Environmental Protection Agency (EPA)
assesses and mitigates health risks associated with pesticides used on
tobacco, and (3) assess the extent to which federal agencies regulate
and test for pesticide residues on tobacco.
What GAO Found:
In the 1990s, domestic growers commonly used 37 pesticides approved for
use on tobacco by EPA. Most of these pesticides were also used on food
crops. When used in ways that deviate from conditions set by EPA, many
of these pesticides can cause moderate to severe respiratory and
neurological damage”and may result in death. Moreover, animal studies
suggest that some of these pesticides may cause birth defects or cancer.
Under its pesticide registration program, EPA evaluates toxicity and
other data to assess health risks to workers and the public from
exposure to pesticides”and risks to smokers from exposure to residues
in smoke. These assessments have identified a range of risks that
required such mitigation as limiting where and how the pesticide may be
used, prohibiting use in certain states, and requiring workers to wear
respirators and chemical-resistant clothing. On the other hand, EPA
has concluded that low levels of residues in tobacco smoke do not pose
short-term health concerns requiring mitigation. EPA does not assess
intermediate or long-term risks to smokers because of the severity of
health effects linked to use of tobacco products themselves.
While EPA regulates the specific pesticides that may be used on tobacco
and other crops and specifies how the pesticides may be used, it does
not otherwise regulate residues of pesticides approved for use on
tobacco. USDA, however, is required by the Dairy and Tobacco
Adjustment Act to test imported and domestic tobacco for residues of
pesticides not approved by EPA for use on tobacco that federal
officials believe are used in other countries. By helping ensure that
other countries do not use highly toxic pesticides that U.S. tobacco
growers may not use, federal regulation of pesticide residues on
tobacco addresses trade equity as well as health and environmental
issues. However, USDA has not reevaluated the list of pesticides for
which it tests since 1989, even though EPA has cancelled tobacco use
for over 30 pesticides since then.
What GAO Recommends:
GAO recommends that the Secretary of the Department of Agriculture
direct the Administrators of the Agricultural Marketing Service and
the Farm Service Agency to periodically review and update the
pesticides on tobacco for which they set residue limits and test
imported and domestic tobacco.
Commenting on a draft of this report, EPA officials said GAO accurately
characterized the agency‘s risk assessment process for pesticides used
on tobacco, and Department of Agriculture officials agreed with GAO‘s
recommendation to periodically review and update the pesticides for
which the department sets residue limits and tests tobacco.
www.gao.gov/cgi-bin/getrpt?GAO-03-485.
To view the full report, including the scope
and methodology, click on the link above.
For more information, contact John B. Stephenson at (202) 512-3841 or
stephensonj@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
Pesticides Commonly Used on Tobacco Have Potential Short-and Long-Term
Adverse Health Effects:
EPA Concludes that Health Risks of Pesticide Residues on Tobacco Are
Minimal but Requires Mitigation for Risks from Other Exposures:
Federal Regulation of Pesticide Residues on Tobacco Is Limited:
Conclusions:
Recommendation for Executive Action:
Agency Comments:
Appendix I: Objectives, Scope, and Methodology:
Appendix II: Pesticide Use on Tobacco and Other Crops:
Appendix III: Germany, Italy, and Spain Have Adopted Regulatory Limits
for Pesticide Residues on Tobacco:
Appendix IV: USDA Tests Domestic Tobacco in the Loan Stock Program:
Appendix V: GAO Contacts and Staff Acknowledgments:
Tables:
Table 1: Pesticides Commonly Used on Domestic Tobacco, 1990-98:
Table 2: Pesticide Use on Tobacco, 1990-98:
Table 3: Organochlorine, Organophosphate, and Carbamate Pesticides
Commonly Used on Tobacco in the 1990s:
Table 4: Margins of Exposure for Five Pesticides Approved for Use on
Tobacco 29:
Table 5: USDA's Residue Limits for Pesticides on Tobacco:
Table 6: Pesticide Use on Tobacco and All Crops, 1990-98:
Table 7: Residue Limits Adopted by Germany, Italy, and Spain for
Pesticides Commonly Used on Tobacco in the United States during the
1990s:
Figure:
Figure 1: EPA's Tiered Approach to Assessing Health Risks of Exposure
to Residues on Tobacco:
Abbreviations:
1,3-D: 1,3-dichloropropene:
2,4-D: 2,4-dichlorophenoxyacetic acid:
2,4,5-T: 2,4,5-trichlorophenoxyacetic acid:
AMS: Agricultural Marketing Service:
CORESTA: Cooperation Centre for Scientific Research Relative to Tobacco:
DBCP: Dibromocloropropane:
DDE: Dichlorodiphenyldichloroethylene:
DDT: Dichlorodiphenyltrichloroethane:
EDB: Ethylene dibromide:
EPA: Environmental Protection Agency:
FDA: Food and Drug Administration:
FFDCA: Federal Food, Drug, and Cosmetic Act:
FIFRA: Federal Insecticide, Fungicide, and Rodenticide Act:
FQPA: Food Quality Protection Act:
FSA: Farm Service Agency:
HCB: Hexachlorobenzene:
NCFAP: National Center for Food and Agricultural Policy:
NCSU: North Carolina State University:
ppm: parts per million:
TDE: Tetrachlorodiphenylethane:
TTR: total toxic residue:
USDA: U.S. Department of Agriculture:
:
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protection in the United States. It may be reproduced and distributed
in its entirety without further permission from GAO. It may contain
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copyrighted materials separately from GAO's product.
[End of section]
United States General Accounting Office:
Washington, DC 20548:
March 26, 2003:
The Honorable Henry A. Waxman
Ranking Minority Member
Committee on Government Reform
House of Representatives:
Dear Mr. Waxman:
As you know, pesticides are used regularly on food and nonfood crops,
such as tobacco, to control a range of unwanted animal, plant, and
microbial pests.[Footnote 1] Trace amounts of pesticides, called
residues, remain on tobacco and other crops after treatment. Typically,
the residue levels on tobacco decline as the leaves are harvested,
dried, and further processed into consumer products, and still further
when the tobacco is burned. However, varying residue levels may remain.
As a result, human exposure to pesticide residues on tobacco may occur
when residues remaining in cigarette smoke are inhaled. While much is
known about the significant health risks of using tobacco products,
limited information exists on the extent to which the use of pesticides
on tobacco may increase the considerable health risks associated with
tobacco use itself.
By controlling pests that reduce crop yields, pesticides can provide
more abundant supplies of fruits, vegetables, and other crops.
Nonetheless, pesticides are generally designed to be toxic to living
organisms and thus can have significant adverse health effects if used
improperly. The Environmental Protection Agency (EPA) determines
whether and under what conditions pesticides can be used in the United
States without posing an unreasonable risk to human health or the
environment. Pesticides that meet EPA's requirements are granted
licenses or "registrations," which permit their distribution, sale, and
use according to specific directions and requirements identified on the
labels. In addition, the U.S. Department of Agriculture (USDA) and the
Food and Drug Administration (FDA) monitor crops for certain pesticide
residues.
In response to your request for information on how the federal
government addresses the public health implications of pesticides on
tobacco, this report describes (1) the pesticides commonly used on
tobacco and the potential health risks associated with them; (2) how
EPA assesses and mitigates health risks associated with pesticides used
on tobacco; and (3) how, and the extent to which, federal agencies
regulate and monitor pesticide residues on tobacco. Several pesticide
use surveys conducted or sponsored by the federal government provide
information on the types and amounts of pesticides commonly used on
tobacco and other crops in the 1990s. These data, available through
1998, estimate average annual agricultural use of pesticides, excluding
such uses as pest control in greenhouses. To determine how EPA assesses
and mitigates health risks associated with pesticides used on tobacco,
we reviewed, among other things, studies and documentation related to
13 pesticides commonly used on tobacco that EPA evaluated under its
reregistration program between 1994 and 2002. For more details on our
scope and methodology, see appendix I.
Results in Brief:
Surveys conducted during the 1990s indicate that tobacco producers in
the United States commonly used 37 pesticides approved for such use by
EPA, most of which were also approved for use on food crops. When used
in ways that deviate from the conditions set by EPA, many of these
pesticides can cause moderate to severe respiratory and neurological
damage--and may result in death. Further, animal studies suggest that
some of these pesticides may cause birth defects and cancer. About half
of the pesticides used on tobacco work primarily by preventing the
normal flow of nerve impulses to muscles and are among those most often
implicated in poisonings, injuries, and illnesses. In humans, symptoms
appear within minutes to hours after exposure and range from tightness
in the chest, headache, nausea, and dizziness to death from respiratory
failure.
EPA bases its assessments of the health risks to both workers and the
general population from exposure to the pesticides that are used on
tobacco and other crops on its evaluation of a wide range of toxicity,
residue, and other data. Workers are exposed through mixing and
applying pesticides, and the general population is exposed through
pesticide products used in the home and in public places and through
pesticide residues in food and water. EPA also assesses the health
risks to smokers from exposure to pesticide residues that remain in
cigarette smoke by analyzing data on the toxicity of specific
pesticides and the residue levels that remain on tobacco and in tobacco
smoke. EPA's assessments of risks to workers and the public from
exposure to pesticides that are used on tobacco and other crops have
identified a range of potential adverse health effects. To mitigate
such effects, EPA has set special limitations on where and how some
pesticides may be used, such as requiring workers who use them to wear
respirators and chemical-resistant clothing, prohibiting their use in
certain states to avoid high pesticide levels in groundwater used for
drinking, and not permitting certain uses at all. On the other hand,
EPA has generally concluded that the low levels of residues measured in
tobacco smoke do not pose short-term health concerns. EPA does not
assess the additional risk of either intermediate-or long-term exposure
to pesticide residues in smoke because of the severity and quantity of
health effects associated with the use of tobacco products themselves.
In addition, the agency does not include short-, intermediate-, or
long-term exposure to residues on tobacco in its assessments of total
exposures to the pesticides. Officials and experts with whom we spoke
generally agreed that pesticide residues on tobacco could incrementally
increase health risks, though some also said the known harm from using
tobacco products dwarfs any potential effect from exposure to pesticide
residues in the smoke.
While EPA regulates the specific pesticides that may be used on tobacco
and other crops and specifies how the pesticides it approves may be
used, EPA does not otherwise regulate the residues of pesticides
approved for use on tobacco and other nonfood crops. USDA, however, is
required by the Dairy and Tobacco Adjustment Act, as amended, to test
domestic and imported tobacco for pesticides not approved for use on
tobacco by EPA. As a result, federal regulation of pesticide residues
on tobacco is limited to selected pesticides that are not approved by
EPA for such use in the United States. USDA tests most imported
tobacco, as well as the portion of domestic tobacco the federal
government acquires under the tobacco price support program, for
residues of 20 pesticides not approved for use on tobacco that federal
officials believe are used in some other countries. Most of these
pesticides, such as DDT, are highly toxic, persist in the environment,
and accumulate in the bodies of humans and animals.[Footnote 2] By
helping to ensure that other countries do not use pesticides that U.S.
tobacco growers are not allowed to use, the federal regulation of
pesticide residues on tobacco addresses trade equity as well as health
and environmental issues. USDA has not reevaluated since 1989 the
pesticides the department monitors in its tobacco pesticide residue
testing program, although EPA has subsequently cancelled tobacco uses
for at least 30 pesticides not currently monitored by USDA.
Consequently, USDA's testing program excludes some highly toxic
pesticides that may still be used in other countries. To better protect
the public from residues not approved for use on tobacco, we are
recommending that USDA periodically reevaluate the pesticides it
includes in its testing program.
Background:
Tobacco is a high-value, pesticide-intensive crop. That is, tobacco is
the nation's ninth highest valued crop, and in terms of the amount of
pesticide applied per acre, tobacco ranks sixth--behind potatoes,
tomatoes, citrus, grapes, and apples. In the United States, tobacco is
grown in 16 states, 2 of which--Kentucky and North Carolina--produce
about two-thirds of all domestic tobacco.[Footnote 3] Further, it is
grown in over 100 countries. Until recently, the United States was the
world's leading exporter of unmanufactured tobacco; however, in 2001,
it ranked third, behind Brazil and Zimbabwe. The tobacco industry in
the United States both exports tobacco to Japan and Western Europe--
principally Germany, the Netherlands, Denmark, the United Kingdom,
Belgium, Italy, and Spain--and imports tobacco in increasing amounts
from countries such as Brazil, Argentina, Malawi, and Thailand.
Furthermore, the United States is the second largest producer of
cigarettes in the world, following China. More than 90 percent of the
tobacco grown in the United States is used to manufacture cigarettes,
as is most tobacco produced in the world. The remainder is used for
chewing tobacco, snuff, cigars, and pipe tobacco. Tobacco types are
often defined by such characteristics as how the tobacco is cured
(flue-, air-, or sun-cured), as well as the color, size, and thickness
of the leaves. Different types of tobacco are used in the various
tobacco products. The tobacco component of cigarettes made in the
United States usually consists of flue-cured and burley tobacco blended
with imported oriental tobacco and small amounts of specialty tobaccos
grown in Maryland and Pennsylvania.[Footnote 4]
Although pesticides play a significant role in increasing production of
tobacco, food, and other crops by reducing the number of crop-
destroying pests, exposure to pesticides can harm humans. The potential
for harm is related to both the amount of a substance a person is
exposed to--the dose--and the toxicity of the chemical. For example,
small doses of aspirin can be beneficial to people, but at very high
doses, this common medicine can be deadly. Furthermore, in some
individuals, even at very low doses, aspirin may be lethal. The age and
health status of an individual can also affect the potential for harm.
Children may be more susceptible to harm because, for example, they eat
more food, drink more water, and breathe more air than adults per pound
of body weight, resulting in greater exposure. Generally, assessments
of dose and response involve considering the dose levels at which
adverse effects are observed in test animals and using these dose
levels to calculate an equivalent dose in humans.
In many cases, exposure to pesticides is through residues that remain
on crops following use of the pesticides. The amount of pesticide
residue that remains reflects, among other things, the amount of
pesticide applied, the time lapsed since application, and the speed
with which the pesticide dissipates in the environment. Residue levels
remaining on crops are also affected by where the pesticides are
applied, such as in the soil or on the plant, and when they are used in
the life cycle of the plant, such as when the plant is a seedling or
shortly before the plant is harvested. Typically, residues on tobacco
decline as the plant moves from field to finished consumer product.
The primary federal requirements pertaining to the registration, sale,
and use of pesticides are in the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act
(FFDCA), both as amended by the Food Quality Protection Act (FQPA).
Pesticides must generally be registered with EPA in order to be sold or
distributed. EPA will register a pesticide if it determines, among
other things, that the pesticide will not generally cause unreasonable
adverse effects on human health or the environment when used in
accordance with conditions specified on the label. Throughout this
report we will focus on EPA's analysis of potentially harmful effects
to human health, rather than the environment.
In 1988 FIFRA was amended to require that EPA review pesticides
initially registered prior to November 1984--when less toxicity data
were available--to consider their health effects and to determine
whether and how they might continue to be registered. These reviews are
designed to ensure that older pesticides meet contemporary health and
safety standards and that their risks are mitigated. Essentially,
manufacturers of the older pesticides must provide EPA with
substantially the same toxicity, chemistry, and other data as are now
required to register a new pesticide.[Footnote 5] EPA reviews of the
older pesticides are called reregistrations. Most of the pesticides
used on tobacco during the 1990s were initially approved before 1984
and therefore are subject to reregistration.
In addition, the FQPA amendments to FIFRA passed in 1996 require EPA to
reevaluate the amounts of pesticide residues allowed on or in food--
known as tolerances. EPA must ensure that there is a reasonable
certainty that no harm will result from all pesticide exposures from
food and nonfood uses for which there is reliable information. In doing
so, unless another safety factor is determined to be appropriate, EPA
is required to apply an additional 10-fold safety factor in setting
tolerances to ensure the safety of foods for children. EPA is also
required to ensure that there is reasonable certainty that no harm will
result to children specifically from "aggregate" exposure to a single
pesticide--that is, from all sources, such as lawn treatments,
household uses, drinking water, and food. EPA must also consider
available information concerning the cumulative effects on children of
pesticides that act in a similar harmful way (known as a common
mechanism of toxicity). To accomplish this requirement, EPA has
recently developed a method to evaluate the cumulative exposure of one
class of highly toxic pesticides--the organophosphates--from residues
in food and drinking water and from residential uses.
EPA uses risk assessment--the systematic, scientific description of
potential adverse effects from exposure to hazardous substances--to
evaluate the potential health impacts of a pesticide on humans and
determine what measures are needed to mitigate identified risks. The
product of a risk assessment is an identification of the various health
risks, along with quantitative and/or qualitative statements regarding
the probability that an exposed population will be harmed and to what
degree. For example, EPA qualitatively classifies pesticides and other
toxic substances according to their potential to cause cancer using
descriptors such as "likely" or "suggestive evidence but not sufficient
to assess human carcinogenic potential." In addition, for many
carcinogens, EPA develops a quantitative dose/response health risk
assessment that estimates the health risks at varying exposures. For
health effects other than cancer, EPA may calculate what it terms a
"reference dose" or, in the case of exposure by inhalation, a
"reference concentration," which represents a daily level of exposure
that is unlikely to result in harm over a lifetime. Alternatively, EPA
may calculate a "margin of exposure," which is a ratio that shows how
far the actual (or estimated) human exposure to a substance is from
levels that are harmful. In essence, evaluating and managing the risk
of exposure to a pesticide involves determining the maximum safe level
of exposure to the pesticide and assessing whether expected actual
exposure is below this maximum level. If expected actual exposure
levels exceed the maximum safe amount, EPA must determine the best ways
to reduce exposure.
Pesticides Commonly Used on Tobacco Have Potential Short-and Long-Term
Adverse Health Effects:
According to federally sponsored surveys, during the 1990s tobacco
producers in the United States commonly used 37 of the pesticides
approved by EPA for such use.[Footnote 6] As shown in table 1, most of
the pesticides used on tobacco were insecticides and herbicides, which
control insect and plant pests; others were fungicides, which combat
fungal diseases, or plant growth regulators; and a few had more than
one use.[Footnote 7]
Table 1: Pesticides Commonly Used on Domestic Tobacco, 1990-
98:
Primary use(s): Insecticide; Pesticide: Acephate, aldicarb, Bacillus
thuringiensis, carbaryl, carbofuran, chlorpyrifos, diazinon,
disulfoton, endosulfan, ethoprop, fenamiphos, fonofos, imidacloprid,
malathion, methidathion, methomyl, spinosad, trichlorfon.
Primary use(s): Herbicide; Pesticide: Benefin, clomazone, diphenamid,
isopropalin, napropamide, pebulate, pendimethalin, sethoxydim,
sulfentrazone.
Primary use(s): Fungicide; Pesticide: Dimethomorph, mancozeb,
mefenoxam, metalaxyl.
Primary use(s): Plant growth regulator; Pesticide: Ethephon,
flumetralin.
Primary use(s): Plant growth regulator, herbicide; Pesticide: Maleic
hydrazide.
Primary use(s): Fumigant, insecticide; Pesticide: Chloropicrin.
Primary use(s): Fumigant, insecticide, herbicide; Pesticide: Methyl
bromide.
Primary use(s): Fungicide, insecticide, herbicide; Pesticide: 1,3-
dichloropropene (1,3-D).
Source: EPA, International Organization for Standardization, National
Center for Food and Agricultural Policy, and USDA.
Note: GAO's analysis of EPA, International Organization for
Standardization, National Center for Food and Agricultural Policy, and
USDA data.
[End of table]
Most of these pesticides were also widely used on food crops. The
actual number and amount of pesticides used on tobacco or other crops
in any given year vary depending on factors such as the weather and the
specific pests that become problematic. For example, the incidence of
many plant diseases is closely correlated to the amount of rainfall,
resulting in greater use of fungicides in years with high rainfall. In
addition, pesticide use tends to change over time as pests develop
resistance to the pesticides and as use on tobacco is approved for new
pesticides and cancelled for older pesticides.[Footnote 8] As table 2
shows, 10 pesticides identified in the 1997 survey as commonly used on
tobacco were not identified in the earlier survey. Two of these
pesticides, dimethomorph and mancozeb, began to be used in response to
the appearance of a disease resistant to metalaxyl, which declined in
usage during the 1990s. In addition, during the years included in the
1997 survey, tobacco use for 5 of the 7 pesticides no longer reported
as being used--diazinon, diphenamid, isopropalin, methidathion, and
trichlorfon--was being cancelled.[Footnote 9] In some cases, pesticide
cancellations resulted in the increased use of other pesticides. For
example, by 1997 clomazone had replaced diphenamid and isopropalin as
the pesticide of choice for controlling unwanted weeds, and
imidacloprid was most commonly used to control insect pests, leading to
reduced use of acephate, aldicarb, chlorpyrifos, ethoprop, and
carbofuran. Manufacturers may initiate cancellation of some or all uses
of a pesticide, often for economic reasons,[Footnote 10] or EPA may
cancel uses when the agency determines that one or more uses pose
unreasonable risks to human health or the environment. For example, as
required under the Clean Air Act, EPA has been phasing out the use of
methyl bromide on tobacco and a wide range of other crops because it
depletes the earth's protective layer of ozone.[Footnote 11] Methyl
bromide use on tobacco decreased from about 5.4 million pounds in 1992
to about 0.7 million pounds in 1997 because of EPA's efforts and
changes in how tobacco producers raise seedlings. Specifically,
producers have begun to grow tobacco seedlings in greenhouses, where
methyl bromide is not generally used.
Table 2: Pesticide Use on Tobacco, 1990-98:
Pesticide: 1,3-dichloropropene (1,3-D); Pounds used on tobacco: 1992
survey (1990-93): 11,537,540; Pounds used on tobacco: 1997 survey
(1994-98): 13,279,285.
Pesticide: Chloropicrin; Pounds used on tobacco: 1992 survey (1990-93):
577,082; Pounds used on tobacco: 1997 survey (1994-98): 6,761,644.
Pesticide: Maleic hydrazide; Pounds used on tobacco: 1992 survey (1990-
93): 1,789,208; Pounds used on tobacco: 1997 survey (1994-98):
1,790,089.
Pesticide: Acephate; Pounds used on tobacco: 1992 survey (1990-93):
1,570,457; Pounds used on tobacco: 1997 survey (1994-98): 871,899.
Pesticide: Methyl bromide; Pounds used on tobacco: 1992 survey (1990-
93): 5,356,748; Pounds used on tobacco: 1997 survey (1994-98): 685,026.
Pesticide: Pendimethalin; Pounds used on tobacco: 1992 survey (1990-
93): 321,931; Pounds used on tobacco: 1997 survey (1994-98): 473,718.
Pesticide: Chlorpyrifos; Pounds used on tobacco: 1992 survey (1990-93):
685,554; Pounds used on tobacco: 1997 survey (1994-98): 406,822.
Pesticide: Fenamiphos; Pounds used on tobacco: 1992 survey (1990-93):
257,142; Pounds used on tobacco: 1997 survey (1994-98): 379,841.
Pesticide: Mancozeb; Pounds used on tobacco: 1992 survey (1990-93):
[A]; Pounds used on tobacco: 1997 survey (1994-98): 356,811.
Pesticide: Flumetralin; Pounds used on tobacco: 1992 survey (1990-93):
[A]; Pounds used on tobacco: 1997 survey (1994-98): 352,742.
Pesticide: Metalaxyl; Pounds used on tobacco: 1992 survey (1990-93):
371,645; Pounds used on tobacco: 1997 survey (1994-98): 271,368.
Pesticide: Clomazone; Pounds used on tobacco: 1992 survey (1990-93):
[A]; Pounds used on tobacco: 1997 survey (1994-98): 217,617.
Pesticide: Ethoprop; Pounds used on tobacco: 1992 survey (1990-93):
438,274; Pounds used on tobacco: 1997 survey (1994-98): 182,321.
Pesticide: Endosulfan; Pounds used on tobacco: 1992 survey (1990-93):
[A]; Pounds used on tobacco: 1997 survey (1994-98): 172,766.
Pesticide: Mefenoxam; Pounds used on tobacco: 1992 survey (1990-93):
[A]; Pounds used on tobacco: 1997 survey (1994-98): 139,199.
Pesticide: Pebulate; Pounds used on tobacco: 1992 survey (1990-93):
412,000; Pounds used on tobacco: 11,537,540: 577,082: 1,789,208:
1,570,457: 5,356,748: 321,931: 685,554: 257,142: [A]: [A]: 371,645:
[A]: 438,274: [A]: [A]: 131,665.
Pesticide: Ethephon; Pounds used on tobacco: 1992 survey (1990-93):
113,238; Pounds used on tobacco: 11,537,540: 577,082: 1,789,208:
1,570,457: 5,356,748: 321,931: 685,554: 257,142: [A]: [A]: 371,645:
[A]: 438,274: [A]: [A]: 102,130.
Pesticide: Napropamide; Pounds used on tobacco: 1992 survey (1990-93):
191,840; Pounds used on tobacco: 11,537,540: 577,082: 1,789,208:
1,570,457: 5,356,748: 321,931: 685,554: 257,142: [A]: [A]: 371,645:
[A]: 438,274: [A]: [A]: 92,622.
Pesticide: Sulfentrazone; Pounds used on tobacco: 1992 survey (1990-
93): [A]; Pounds used on tobacco: 11,537,540: 577,082: 1,789,208:
1,570,457: 5,356,748: 321,931: 685,554: 257,142: [A]: [A]: 371,645:
[A]: 438,274: [A]: [A]: 69,073.
Pesticide: Imidacloprid; Pounds used on tobacco: 1992 survey (1990-93):
[A]; Pounds used on tobacco: 11,537,540: 577,082: 1,789,208: 1,570,457:
5,356,748: 321,931: 685,554: 257,142: [A]: [A]: 371,645: [A]: 438,274:
[A]: [A]: 67,896.
Pesticide: Aldicarb; Pounds used on tobacco: 1992 survey (1990-93):
159,044; Pounds used on tobacco: 11,537,540: 577,082: 1,789,208:
1,570,457: 5,356,748: 321,931: 685,554: 257,142: [A]: [A]: 371,645:
[A]: 438,274: [A]: [A]: 59,719.
Pesticide: Dimethomorph; Pounds used on tobacco: 1992 survey (1990-93):
[A]; Pounds used on tobacco: 11,537,540: 577,082: 1,789,208: 1,570,457:
5,356,748: 321,931: 685,554: 257,142: [A]: [A]: 371,645: [A]: 438,274:
[A]: [A]: 36,818.
Pesticide: Methomyl; Pounds used on tobacco: 1992 survey (1990-93):
57,137; Pounds used on tobacco: 11,537,540: 577,082: 1,789,208:
1,570,457: 5,356,748: 321,931: 685,554: 257,142: [A]: [A]: 371,645:
[A]: 438,274: [A]: [A]: 29,773.
Pesticide: Malathion; Pounds used on tobacco: 1992 survey (1990-93):
7,549; Pounds used on tobacco: 11,537,540: 577,082: 1,789,208:
1,570,457: 5,356,748: 321,931: 685,554: 257,142: [A]: [A]: 371,645:
[A]: 438,274: [A]: [A]: 15,437.
Pesticide: Disulfoton; Pounds used on tobacco: 1992 survey (1990-93):
52,578; Pounds used on tobacco: 11,537,540: 577,082: 1,789,208:
1,570,457: 5,356,748: 321,931: 685,554: 257,142: [A]: [A]: 371,645:
[A]: 438,274: [A]: [A]: 13,495.
Pesticide: Sethoxydim; Pounds used on tobacco: 1992 survey (1990-93):
[A]; Pounds used on tobacco: 11,537,540: 577,082: 1,789,208: 1,570,457:
5,356,748: 321,931: 685,554: 257,142: [A]: [A]: 371,645: [A]: 438,274:
[A]: [A]: 9,579.
Pesticide: Spinosad; Pounds used on tobacco: 1992 survey (1990-93):
[A]; Pounds used on tobacco: 11,537,540: 577,082: 1,789,208: 1,570,457:
5,356,748: 321,931: 685,554: 257,142: [A]: [A]: 371,645: [A]: 438,274:
[A]: [A]: 2,815.
Pesticide: Carbaryl; Pounds used on tobacco: 1992 survey (1990-93):
16,487; Pounds used on tobacco: 11,537,540: 577,082: 1,789,208:
1,570,457: 5,356,748: 321,931: 685,554: 257,142: [A]: [A]: 371,645:
[A]: 438,274: [A]: [A]: 2,057.
Pesticide: Fonofos; Pounds used on tobacco: 1992 survey (1990-93):
12,798; Pounds used on tobacco: 11,537,540: 577,082: 1,789,208:
1,570,457: 5,356,748: 321,931: 685,554: 257,142: [A]: [A]: 371,645:
[A]: 438,274: [A]: [A]: 16.
Pesticide: Benefin; Pounds used on tobacco: 1992 survey (1990-93):
56,963; Pounds used on tobacco: 11,537,540: 577,082: 1,789,208:
1,570,457: 5,356,748: 321,931: 685,554: 257,142: [A]: [A]: 371,645:
[A]: 438,274: [A]: [A]: [A].
Pesticide: Bacillus thuringiensis; Pounds used on tobacco: 1992 survey
(1990-93): [B]; Pounds used on tobacco: 11,537,540: 577,082: 1,789,208:
1,570,457: 5,356,748: 321,931: 685,554: 257,142: [A]: [A]: 371,645:
[A]: 438,274: [A]: [A]: [B].
Pesticide: Carbofuran; Pounds used on tobacco: 1992 survey (1990-93):
149,965; Pounds used on tobacco: 11,537,540: 577,082: 1,789,208:
1,570,457: 5,356,748: 321,931: 685,554: 257,142: [A]: [A]: 371,645:
[A]: 438,274: [A]: [A]: [A].
Pesticide: Diazinon; Pounds used on tobacco: 1992 survey (1990-93):
53,670; Pounds used on tobacco: 11,537,540: 577,082: 1,789,208:
1,570,457: 5,356,748: 321,931: 685,554: 257,142: [A]: [A]: 371,645:
[A]: 438,274: [A]: [A]: [A].
Pesticide: Diphenamid; Pounds used on tobacco: 1992 survey (1990-93):
81,624; Pounds used on tobacco: 11,537,540: 577,082: 1,789,208:
1,570,457: 5,356,748: 321,931: 685,554: 257,142: [A]: [A]: 371,645:
[A]: 438,274: [A]: [A]: [A].
Pesticide: Isopropalin; Pounds used on tobacco: 1992 survey (1990-93):
129,287; Pounds used on tobacco: 11,537,540: 577,082: 1,789,208:
1,570,457: 5,356,748: 321,931: 685,554: 257,142: [A]: [A]: 371,645:
[A]: 438,274: [A]: [A]: [A].
Pesticide: Methidathion; Pounds used on tobacco: 1992 survey (1990-93):
68; Pounds used on tobacco: 11,537,540: 577,082: 1,789,208: 1,570,457:
5,356,748: 321,931: 685,554: 257,142: [A]: [A]: 371,645: [A]: 438,274:
[A]: [A]: [A].
Pesticide: Trichlorfon; Pounds used on tobacco: 1992 survey (1990-93):
722; Pounds used on tobacco: 11,537,540: 577,082: 1,789,208: 1,570,457:
5,356,748: 321,931: 685,554: 257,142: [A]: [A]: 371,645: [A]: 438,274:
[A]: [A]: [A].
Pesticide: Total used on tobacco; Pounds used on tobacco: 1992 survey
(1990-93): 24,400,552; Pounds used on tobacco: 11,537,540: 577,082:
1,789,208: 1,570,457: 5,356,748: 321,931: 685,554: 257,142: [A]: [A]:
371,645: [A]: 438,274: [A]: [A]: 26,974,241.
Source: National Center for Food and Agricultural Policy.
[A] Not identified as being used in the survey.
[B] Neither survey estimated the use of Bacillus thuringiensis in
pounds.
[End of table]
EPA determines the amounts and conditions under which a pesticide may
be used so that it will not pose unreasonable risks to workers or the
general population. Failure to comply with the conditions set by EPA
could result in a range of harmful effects. For example, 17 of the 37
pesticides commonly used on tobacco in the 1990s belong to three
chemical classes that, at high doses, are known to cause adverse human
health effects up to and including death (see table 3).
Table 3: Organochlorine, Organophosphate, and Carbamate
Pesticides Commonly Used on Tobacco in the 1990s:
Chemical class: Organochlorine; Pesticide name: Endosulfan.
Chemical class: Organophosphate; Pesticide name: Acephate,
chlorpyrifos, diazinon, disulfoton, ethoprop, fenamiphos, fonofos,
malathion, methidathion, trichlorfon.
Chemical class: Carbamate; Pesticide name: Aldicarb, carbaryl,
carbofuran, mancozeb, methomyl, pebulate.
Source: EPA, National Center for Food and Agricultural Policy, and
USDA.
Note: GAO's analysis of EPA, National Center for Food and Agricultural
Policy, and USDA data.
[End of table]
Although they do not all produce their toxic effects in the same way,
pesticides in these three classes--organochlorines, organophosphates,
and carbamates--act on the nervous system to prevent the normal flow of
nerve impulses to muscles that control both voluntary movement, such as
walking, and involuntary movement, such as breathing and heart beat.
Pesticides in all three classes are absorbed to varying degrees through
inhalation, ingestion, and skin contact. Exposure to amounts of these
pesticides that exceed levels set by EPA could result in immediate and
life-threatening effects, such as respiratory failure, or conditions
that do not appear immediately, such as cancer. While EPA has concluded
that most of these 17 pesticides do not cause birth defects, the agency
has also concluded that 5 of them and a by-product of another may cause
cancer.[Footnote 12]
Since the 1970s, EPA has severely restricted its approvals of
organochlorine pesticides, which include DDT, aldrin, and chlordane,
because of their potential to harm humans and the environment.
Organochlorine pesticides persist in the environment--some have
remained in soil for over 50 years--and accumulate in body tissue,
particularly fat. Organochlorine pesticides are associated with a range
of adverse health effects, including cancer and damage to the
neurological and reproductive systems. The one organochlorine pesticide
still approved for use on tobacco, endosulfan, is highly toxic when
ingested or inhaled and slightly toxic through contact with the skin.
While EPA has determined that it is unlikely to cause cancer as other
members of this class do, endosulfan, like all organochlorine
pesticides, primarily affects the nervous system. EPA has requested
additional data from the manufacturer to address its concerns that
exposure to endosulfan could harm the nervous system of developing
fetuses. Organophosphate and carbamate pesticides have largely replaced
the organochlorine pesticides in the United States.
While they break down quickly in the environment and do not accumulate
in body tissues, organophosphate pesticides are much more acutely toxic
to humans and animals than the persistent organochlorine pesticides
they have largely replaced. The primary cause of death from
organophosphate poisoning is respiratory failure, although
cardiovascular symptoms, such as decreased heart rate that progresses
to cardiac arrest, usually occur as well. In humans, additional
symptoms from exposure to organophosphate pesticides, which can develop
during use or within minutes to hours after exposure, include headache,
nausea, dizziness, sweating, muscle twitching, anxiety, and depression.
Exposure by inhalation causes the most rapid appearance of toxic
symptoms. As a result, to minimize the potential for harmful exposure
of workers, EPA requires those who mix, use, or apply the pesticides to
have special training, use respirators, and wear chemical-resistant
clothing. Regarding the potential to cause cancer, EPA has determined
that 4 of the 10 organophosphate pesticides used on tobacco--acephate,
ethoprop, methidathion, and trichlorfon--may cause cancer. In addition,
EPA has concluded that 7 of the 8 organophosphate pesticides it
evaluated for their potential to cause birth defects would not cause
them but that the eighth--chlorpyrifos--may do so at very high levels
that may also harm the pregnant female.[Footnote 13]
Carbamates, which also affect the central nervous system, produce
symptoms similar to those of organophosphate pesticides, although the
effects of carbamate poisoning tend to be of shorter duration and
somewhat easier to treat. The primary cause of death from carbamate
poisoning is respiratory failure. Of the six carbamate pesticides used
on tobacco, EPA has determined that one and a by-product always
associated with another may cause cancer; two are unlikely to cause
cancer; data are insufficient to determine the cancer-causing potential
of one; and one will be evaluated in fiscal year 2003. EPA has
evaluated four of the carbamates for their potential to cause birth
defects: three do not and only minimal evidence exists for the
potential of the fourth to cause birth defects. EPA has requested, but
not yet received, data from the manufacturer on the potential of one of
the two remaining carbamate pesticides to produce birth defects, and
the agency will evaluate the health effects of the other in fiscal year
2003.
The potential acute adverse health effects from the remaining 20
pesticides used on tobacco--representing 12 different chemical classes-
-range from mild to severe.[Footnote 14] For example, EPA found no
known health effects on mammals from exposure to Bacillus thuringiensis
as it is currently manufactured. Similarly, EPA has found that both
maleic hydrazide, a plant growth regulator and herbicide, and
metalaxyl, a fungicide, have low acute toxicity, and neither is thought
to cause cancer or birth defects. However, EPA has found that serious
adverse health effects could occur with high exposures to insecticides,
such as chloropicrin, 1,3-dichloropropene (1,3-D), and methyl bromide,
which are applied as fumigants and can be severely irritating to the
eyes, skin, and lungs. EPA has also found that poisoning from exposure
to methyl bromide may result in persistent neurological impairment.
In general, because most of the pesticides used on tobacco are widely
used on food and other crops, as well as in residential and other
settings, the exposure resulting from residues on tobacco represents a
small portion of total exposure to these pesticides. Specifically, 1997
survey data estimate that about 27 million pounds of the 37 pesticides
were used on tobacco, while the estimated use of these pesticides
nationally on all crops was 175 million pounds. Therefore, most of the
exposure to these pesticides stems from their use on other crops and in
other products, such as household insecticides. However, for some
pesticides--dimethomorph, fenamiphos, flumetralin, maleic hydrazide,
mefenoxam, and sulfentrazone--more than 50 percent of their use in 1994
through 1998 was on tobacco. Further, more than 80 percent of maleic
hydrazide used and 100 percent of flumetralin and sulfentrazone used
were applied to tobacco. Appendix II provides information on the
amounts of the 37 pesticides used on (1) tobacco and (2) domestic
crops, as estimated in the 1992 and 1997 surveys.
EPA Concludes that Health Risks of Pesticide Residues on Tobacco Are
Minimal but Requires Mitigation for Risks from Other Exposures:
To determine whether the use of individual pesticides can reasonably be
expected not to harm human health, EPA conducts health risk assessments
under its pesticide registration program. These risk assessments are
based on EPA's evaluations of the results of numerous scientific
studies and tests that the agency requires pesticide manufacturers to
carry out. EPA also assesses the health risks to smokers from exposure
to pesticides used on tobacco by analyzing data on their toxicity and
the residue levels that remain on tobacco and in tobacco smoke. Because
pesticides are used extensively on crops, including tobacco, and in
home pesticide products, the risk assessments focus on exposures of (1)
workers who handle the pesticides and (2) the general public, which is
exposed to pesticides via residues on food or in drinking water or from
pesticide products used in and around the home and in public places.
EPA's health risk assessments often identify risks to workers that must
be mitigated before EPA will approve the pesticide. The assessments
also identify risks to the general population that may also require
special limitations on how or where the pesticides may be used. EPA has
generally concluded that the low levels of residues measured in tobacco
smoke do not pose health concerns that require mitigation. While EPA
officials were generally able to provide us with copies of the studies
and evaluations we requested during our review, documentation of the
agency's evaluation of the validity and reliability of the residue
studies was inconsistently available.
EPA Assesses Health Risks of Varied Exposures to Pesticides:
Under its pesticide registration program, EPA routinely assesses the
health risks of exposure to pesticides from residues in drinking water
and food and from pesticide use in the home, in public places, and at
work. The Health Effects Division of the Office of Pesticide Programs
in EPA develops its health risk assessments on the basis of a
substantial body of data, including toxicity, residue chemistry, and
other data provided by pesticide manufacturers, as well as other
relevant information, such as human and animal studies from the general
scientific literature and poisoning incident databases. The risk
assessments focus on the potential cancer and noncancer health risks
associated with short-term (acute), intermediate-, and long-term
(chronic) exposures to pesticides from the primary exposure routes--
oral, inhalation, and contact with skin (dermal). Noncancer health
risks that EPA assesses include risk of birth defects, reproductive
impairments, damage to genetic material, and interference with the
body's endocrine system.[Footnote 15] EPA's health risk assessments are
subject to numerous reviews by a variety of committees, including the
agency's Hazard Identification Science Assessment Review Committee,
Cancer Science Assessment Review Committee, and Reproductive and
Developmental Toxicity Science Assessment Review Committee. The health
risk assessments provide critical information to the pesticide
registration divisions on the human health component of risk management
decisions--such as whether to approve pesticides for use; what amounts
may be used; and what special restrictions, if any, may be needed.
To evaluate the levels of pesticides to which cigarette smokers might
be exposed from residues on tobacco, EPA reviews plant metabolism and
residue studies provided by manufacturers that identify the residues of
pesticides, and any harmful by-products[Footnote 16] they may produce,
that remain on the crop after it has been treated. The plant metabolism
studies reveal how plants process a pesticide once it is applied and
the relative amounts of the pesticide and its by-products that remain
after treatment--the total toxic residue (TTR). The residue studies,
called field trials, quantify the levels of pesticide and by-product
residues that remain on plants grown under actual agricultural
conditions that approximate the expected "real life" environment. Such
field trial data, which are required for all pesticides that will be
used on food, may not always be required for pesticides used on tobacco
because EPA uses a "tiered" approach to evaluate residues on tobacco.
That is, for tobacco, the agency requires additional residue data after
the metabolism study only if it has shown that the combined residue
levels of the pesticide itself and any harmful
by-products exceed 0.1 parts per million (ppm)--the agency's "threshold
of concern" for residues on tobacco. Thus, as figure 1 shows, EPA
generally requires plant metabolism studies for green tobacco and may
require data from field trials for both green and cured (aged) tobacco,
depending upon the amount of residues that are identified.[Footnote 17]
In addition, EPA may require pyrolysis studies that measure the
residues in smoke when tobacco treated with a pesticide is burned.
Finally, EPA may require additional residue studies to estimate
potential exposure, even if the residues are below 0.1 ppm, if it has
concerns about the toxicity of a pesticide.
Figure 1: Figure 1: EPA's Tiered Approach to Assessing Health Risks of
Exposure to Residues on Tobacco:
[See PDF for image]
[A] Residues are measured as TTR--the sum of the residue from the
parent pesticide and its
by-products (degradation products, metabolites, and impurities that are
of toxicological concern).
[B] Pyrolysis refers to chemical change brought about by the action of
heat (burning).
[End of figure]
The tiered approach to analyzing residues on tobacco reflects the fact
that, typically, pesticide residues on tobacco decline over time, as
the tobacco is stored, cured, manufactured into cigarettes, and burned
during smoking.[Footnote 18] EPA uses the tiered approach for tobacco,
in part, because the agency has concluded that the potential for harm
to human health from pesticide residues on tobacco at or below the 0.1-
ppm level is extremely low and unlikely to result in a risk of concern
to smokers.[Footnote 19]
According to EPA officials in the Health Effects Division, since August
1999, EPA's policy for assessing the health risks from using pesticides
on tobacco has been to evaluate the risks of short-term exposure to
residues on tobacco and to quantify the estimated health risks using a
consistent method and set of assumptions.[Footnote 20] This policy is
applied to all newly registered pesticides, as well as to currently
registered pesticides as they are periodically reviewed to ensure they
meet current human health and environmental safety standards in
accordance with the requirements of the 1988 amendments to FIFRA. EPA
officials attribute the more structured approach to advances in the
science of risk assessment and the 1996 enactment of FQPA, which has
spurred the agency to more systematically quantify the exposure to
pesticide residues in food and drinking water and from residential
uses.
EPA selected the margin of exposure method to quantify the health risks
associated with exposure to pesticide residues in smoke. As discussed
earlier, a margin of exposure shows how far the actual (or estimated)
human exposure to a substance is from levels that have been shown to
cause no harm in animal studies. To estimate exposure, EPA typically
uses (1) the residue levels identified in tobacco field trials or
pyrolysis studies and (2) standard assumptions for key variables that
affect exposure. Specifically, EPA assumes that people smoke 15
cigarettes a day[Footnote 21] and that they weigh about 150 pounds, if
male, and 130 pounds, if female. Moreover, EPA assumes 100 percent of
the pesticide residue on the tobacco is inhaled and absorbed. In
practice, some residues will be trapped in cigarette butts, and the
amount of smoke inhaled varies widely among people. EPA officials said
the assumptions are conservative--that is, they are protective of
public health--because they tend to overstate, rather than understate,
the extent to which smokers are exposed to the potentially toxic
effects of the pesticides.
Also according to EPA officials, the agency does not include exposure
to the residues in tobacco smoke in its aggregate health risk
assessments of individual pesticides, which are required by FQPA,
because the added exposure from residues in smoke is minimal. In
addition, EPA has chosen not to assess the risk of either intermediate-
or long-term exposure to pesticide residues in smoke because of the
severity and quantity of health effects associated with the use of
tobacco products themselves. Specifically, exposure to tobacco
products--particularly cigarettes--is the single major preventable
cause of cancer and heart and lung disease in the United States.
Finally, although experts and public health officials are concerned
about the potential for harm, particularly to children, from exposure
to pesticides, little is known directly about the chronic effects of
pesticide use in general in the United States--for example, in
agriculture and in schools.[Footnote 22] Moreover, studies linking
adverse human health effects to exposure to pesticide residues on
tobacco are rare, according to public health officials and experts we
spoke to. And while a number of federally sponsored studies of the
effects of exposure to pesticides are underway, it will be years, if
not decades, before conclusive results are known. Officials and experts
we spoke with about possible harm from pesticide residues on tobacco
generally agreed that such residues could incrementally add to the
risk, and some also believed the known harm from using tobacco products
dwarfs any potential effect from exposure to pesticide residues in the
smoke.
EPA Concludes That Risks Associated with Pesticide Use Can Be
Significant, but Those Associated with Pesticide Residues on Tobacco
Appear to Be Minimal:
EPA's health risk assessments have identified a number of potential
adverse health effects associated with the pesticides used on tobacco
and other crops that, in some cases, have led the agency to impose
special limitations on the uses of these pesticides. The risks that
required mitigation stemmed from (1) potential exposure of workers who
apply pesticides or harvest crops and (2) potential exposure of the
general population to pesticide residues in food or drinking water or
from pesticides used in the home or in public. None of the risks
requiring mitigation were associated with exposure to residues on
tobacco or in tobacco smoke.
Some of EPA's Risk Assessments Result in Special Mitigation Measures:
Our review of studies and other documentation related to EPA's
completed reregistration reviews of 13 of the 37 pesticides commonly
used on tobacco identified the health risks associated with them and
the related mitigation measures the agency required.[Footnote 23] The
following cases illustrate some of the health risks that have required
mitigation.
EPA has classified 1,3-D, a widely used fumigant that controls soil-
borne pests and diseases, as a probable carcinogen--that is, evidence
from human and animal studies suggests that 1,3-D, once ingested or
inhaled, is likely to cause cancer. In its risk assessment, EPA
determined that 1,3-D could make its way to groundwater and pose a risk
of cancer for residents who obtained their drinking water from wells
near treated fields. To mitigate the potential cancer risks and as a
condition for reregistration, EPA required that wells used for drinking
water be located 100 or more feet from treated fields and prohibited
the use of 1,3-D altogether in 11 states with porous soil.[Footnote 24]
In addition, vapors from 1,3-D--which is injected as a liquid into
soil, where it quickly evaporates--can move into the air. Consequently,
EPA also required (1) a 300-foot buffer between occupied buildings and
fields treated with the pesticide and (2) workers who apply the
pesticide to wear respirators and protective clothing, among other
things. Further, because of 1,3-D's volatility and potential to harm
humans, EPA classified it as a "restricted use" pesticide, which means
it can only be applied by, or under the supervision of, individuals
trained to handle particularly toxic or harmful pesticides. Currently,
1,3-D is registered for use on soils in which all food and feed crops
may be planted. Moreover, according to the 1997 survey, an estimated 13
million pounds of 1,3-D were applied to tobacco annually during the
survey period--almost twice the amount of chloropicrin, the second most
commonly used pesticide on tobacco.[Footnote 25] Despite the health
risks posed by injecting 1,3-D into soil, EPA identified no risks
associated with residues on tobacco leaves or in tobacco smoke because
1,3-D metabolizes to nontoxic by-products and is subsequently absorbed
by the plant.[Footnote 26]
Similarly, EPA determined that residues on tobacco of chlorpyrifos--
another pesticide frequently used on tobacco and food crops and one of
the most widely used organophosphate insecticides in the United States-
-were below the agency's threshold of concern. But the agency
determined that chlorpyrifos presented potential health risks unrelated
to its use on tobacco that required strict mitigation measures.
Specifically, the agency identified health risks to children from
exposure to chlorpyrifos. Before 2000, chlorpyrifos was one of the
insecticides used most often in residential and commercial settings--
for example, on carpets and in schools, daycare centers, hotels, and
restaurants--and on food crops. EPA identified significant risks to
children from these many uses and required stringent measures to
address them. Between 1997 and 2000, EPA cancelled nearly all indoor
and outdoor residential uses and prohibited the use of chlorpyrifos in
schools and public parks. In addition, manufacturers agreed to
eliminate the use of chlorpyrifos on tomatoes and restrict its use on
apples.[Footnote 27] EPA also identified concerns for some workers who
mix, load, and apply chlorpyrifos in agricultural and other
nonresidential settings. As a result, EPA required that workers wear a
respirator and a double layer of clothing, including chemical-resistant
gloves, shoes, and headgear. Workers must also use water-soluble
packages to mix powdered forms of chlorpyrifos and remain in an
enclosed cockpit when aerially spraying a field. EPA also set a time
interval between applications of the pesticide and when workers can
reenter treated areas, ranging from 24 hours for most crops to 5 days
for others. EPA did not, however, identify risks associated with
chlorpyrifos used on tobacco because residue levels on green tobacco
were below 0.1 ppm.
EPA also identified a range of potential harmful effects from other
exposures to the other pesticides we reviewed. For 11 pesticides,
including 1,3-D and chlorpyrifos, EPA identified a range of concerns,
largely for exposures of workers--particularly those engaged in
spraying the pesticides--that required at least some mitigation. Most
often the mitigation measures included the use of enclosed mixing
systems and tractor cabs, additional protective respirators and
clothing, reductions in the rate and frequency of application, and
increases in the time between application and reentry to the treated
areas. In some cases, such as for acephate, disulfoton, and ethoprop--
all of which are organophosphate pesticides--certain uses were
cancelled, including use on golf courses and lawns and indoor and
outdoor residential uses. Three of these 11 pesticides--disulfoton,
endosulfan, and ethoprop--also raised concerns about dietary or
drinking water exposure for which EPA required such mitigation as
canceling use on some foods, reducing the rate and frequency of
application on others, and requiring buffer zones between treated
fields and water bodies. EPA placed a number of additional restrictions
on the use of endosulfan, a highly toxic and persistent organochlorine
pesticide, including restricting use on cotton and tobacco to certain
states; eliminating or reducing aerial spray applications on crops such
as strawberries, nuts, and tobacco; and requiring buffer zones between
treated areas and bodies of water.[Footnote 28] In addition, EPA
required that all products containing endosulfan be labeled as
restricted use pesticides, which can only be used by, or under the
supervision of, specially trained applicators.[Footnote 29] EPA also
noted that it may require further restrictions on acephate once the
agency completes its assessment of the cumulative exposure to
organophosphate pesticides because this organophosphate pesticide
degrades in plants to another organophosphate pesticide.[Footnote 30]
EPA found that 2 of the 13 pesticides we reviewed presented no concerns
that needed changes in existing conditions on how to use and apply the
pesticides.[Footnote 31]
The pesticides we reviewed, including ones no longer approved for use
in the United States, are used in many other tobacco-producing
countries, according to experts. Researchers and advocacy groups have
raised concerns about adverse health effects on tobacco workers in
other countries from exposure to pesticides, citing such factors as the
absence of cautionary labels on some pesticides and the limited use of
protective clothing by agricultural workers. For example, researchers
found elevated rates of depression and suicide rates that were twice
the national average among tobacco producers in Brazil, a leading
tobacco exporter. And although many factors, such as poverty and
stress, may play a role in suicide, one group of researchers noted
tobacco producers in Brazil routinely used organophosphate pesticides,
which have been shown to cause depression. Moreover, these researchers
reported that suicides are more likely to occur during planting and
harvesting seasons, when organophosphate pesticides are used
intensively. To some extent, such harmful exposure may occur because
pesticide regulations in other countries may be less stringent than
those in the United States or because other countries' enforcement of
regulations may be more limited, according to advocacy groups.
Regarding pesticide residues on domestic tobacco, overall, EPA
officials did not find associated health risks that required
mitigation. Further, the data we reviewed on 13 pesticides were
consistent with statements from EPA officials that the residues on
tobacco were below the agency's identified level of concern in 11
cases. EPA did not evaluate the remaining 2 pesticides--diazinon and
pendimethalin--for use on tobacco. In the case of diazinon, evaluating
residue data was not relevant because the pesticide was no longer
approved for use on tobacco at the time EPA conducted its evaluation.
In the case of pendimethalin, at the time we conducted this work, EPA
had not yet reviewed the relevant data received from the manufacturer.
EPA approved the reregistration for this pesticide, but its use on
tobacco is subject to the agency's evaluation of this data.
Of the 11 pesticides that EPA evaluated for use on tobacco, 3 left
residues on green or cured tobacco that were less than 0.1 ppm--and one
left no residues at all. Specifically, the maximum residues of ethoprop
on green tobacco were 0.01 ppm, the residues of chlorpyrifos were 0.09
ppm, the residues of pebulate on both green and cured tobacco were less
than
0.02 ppm, and the plant metabolism study for 1,3-D showed no residues
remaining on the plant. Manufacturers provided pyrolysis studies in two
of the four cases in which the residue levels on green tobacco were 0.1
ppm or less. The pyrolysis study for ethoprop identified residues in
the smoke that were below the agency's level of concern. The pyrolysis
study for a by-product of chlorpyrifos that was initially of concern to
the agency identified the by-product in the smoke. However, EPA
subsequently concluded that the by-product, which accounted for more
than 10 percent of the residue in the smoke, was not of toxicological
concern because, unlike its parent compound, it does not act toxically
on the nervous system.
Of the seven pesticides that progressed through EPA's tiered risk
assessment approach because residues on cured tobacco were greater than
0.1 ppm, pyrolysis studies were conducted on five. No residues were
found in the smoke of four of these five pesticides; the residues of
the fifth were not of sufficient magnitude to require further study or
evaluation. One of the remaining two pesticides with residue levels
greater than
0.1 ppm was evaluated using a study of the health effects on rats
exposed to residues in smoke,[Footnote 32] and one was approved subject
to EPA's review of requested additional residue data, including a
pyrolysis study, to confirm EPA's assessment that residues on tobacco
do not pose a risk to human health.
The reregistration decisions for 7 of the 13 pesticides we reviewed
were issued after EPA implemented guidance in 1999 requiring
quantification of the risks of short-term exposure to pesticide
residues in tobacco smoke.[Footnote 33] However, none of the human
health risk assessments or other documentation we reviewed contained
this information--that is, the margin of exposure estimate--because the
health risk assessments supporting these decisions were completed
before the policy was implemented. For pesticides with many uses and
much data, several years may elapse between the initial scientific
assessment of the tobacco use and the issuance of the reregistration
decision.
Not including the 13 pesticides mentioned above, we reviewed five
additional health risk assessments EPA prepared after it developed the
policy requiring the quantification of the risks of short-term exposure
to pesticide residues in tobacco smoke that did include estimates of
margin of exposure. EPA generally does not have concerns about adverse
health effects when a margin of exposure is greater than 100--that is,
when the pesticide causes no adverse effects at levels 100 or more
times greater than the expected actual exposure to the pesticide.
Consequently, a margin of exposure greater than 100 is considered to
reflect risk that is below EPA's level of concern. As table 4 shows,
EPA's recent health risk assessments of five pesticides approved for
use on tobacco--four of which were newly registered and one
reregistered--generally indicated that the margins of exposure were
substantially greater than 100. Although one margin of exposure was
below 100, EPA officials told us that because they used very
conservative assumptions to estimate exposure, resulting in an extreme
overstatement of actual exposure, EPA was not concerned about the
potential for adverse health effects. For these five pesticides, EPA
concluded that no mitigation related to the use on tobacco was
required. Overall, EPA officials said that potential risks from
exposure to residues on tobacco had never been high enough to require
mitigation.
Table 4: Margins of Exposure for Five Pesticides Approved for
Use on Tobacco:
Pesticide: Actigard; Margin of exposure: (male): 518,518; Margin of
exposure: (female): 444,444.
Pesticide: Carbaryl; Margin of exposure: (male): 104; Margin of
exposure: (female): 89.
Pesticide: Dimethomorph; Margin of exposure: (male): 1,400; Margin of
exposure: (female): 1,200.
Pesticide: Pymetrozine; Margin of exposure: (male): 3,333; Margin of
exposure: (female): 2,857.
Pesticide: Thiamethoxam; Margin of exposure: (male): 3,500; Margin of
exposure: (female): 3,000.
Source: GAO and EPA.
Note: GAO's analysis of EPA risk assessment documents.
[End of table]
EPA Evaluations of Studies Are Not Always Available:
EPA requires that pesticide manufacturers provide most of the studies
it considers in assessing the health risks of pesticides, and the
agency's evaluations of these studies are critical to the assessment
process. EPA officials were generally able to provide us with copies of
the studies and evaluations we requested, but documentation of the
agency's evaluation of the quality of the residue studies and other
data upon which it relied to evaluate the potential for adverse health
effects was inconsistent. Specifically, for eight of the pesticides,
EPA officials were unable to provide their evaluations of the validity
and reliability of residue data used in their assessments of potential
health risks. In addition, for chlorpyrifos, EPA officials were unable
to provide the residue studies and agency evaluations of them from the
early 1980s. As a result, we examined subsequent EPA evaluations that
referred to the results of these early studies and the agency's
conclusion that the residues were below the level of concern. According
to EPA officials, they were unable to locate the documents, in part,
because not all records from this time have yet been converted to
electronic format, and the paper copies could not be located among the
substantial backlog of paper documents. EPA officials noted that each
pesticide registration could consist of 100 or more studies from
pesticide manufacturers, each of which requires one or more agency
evaluations. The officials reported that, as resources permit, contract
and agency staff are converting documents to electronic format to make
them more readily available for review.
Federal Regulation of Pesticide Residues on Tobacco Is Limited:
While EPA is required to regulate residues of pesticides approved for
use on human food and animal feed crops, no such requirement applies to
pesticides approved for use on tobacco. However, primarily as a matter
of trade equity, USDA does (1) regulate residues of selected pesticides
that are prohibited in the United States but that may be used on
imported tobacco and (2) test certain types of imported and domestic
tobacco to ensure they do not exceed residue limits. USDA has not
reevaluated the pesticides it regulates since 1989, although changes in
the pesticides used on tobacco have occurred since then. Through its
testing programs, USDA has found that a small fraction of imported and
domestic tobacco exceeds the residue limits.
Federal Regulation Focuses on Pesticides Not Approved for Use on
Tobacco:
As discussed previously, EPA regulates pesticides in the United States
by granting registrations, which permit the distribution, sale, and use
of the pesticides according to directions identified on the label. EPA
also regulates the residues of pesticides that are approved for use on
human food and animal feed crops by setting tolerances--maximum
concentrations of residues that may remain on crops. FDA and USDA test
food and feed crops to ensure that residue levels do not exceed the
tolerances EPA has set. Because tobacco is not used as food or feed,
however, EPA does not set tolerances for residues of pesticides
approved for use on tobacco,[Footnote 34] and FDA and USDA do not test
tobacco for maximum concentrations of residues of approved pesticides.
Consequently, residues of pesticides approved for use on tobacco in the
United States are not federally regulated.
Instead, federal regulation of pesticide residues on tobacco focuses
exclusively on pesticides not approved for use on tobacco. The Dairy
and Tobacco Adjustment Act of 1983, as amended, requires USDA to
(1) establish maximum allowable concentrations for residues of selected
pesticides that are not approved for use on tobacco in the United
States but that are likely used on tobacco in some other countries and
(2) test imported and domestic flue-cured and burley tobacco to ensure
the residue levels do not exceed the maximum levels allowed.[Footnote
35] In selecting which pesticide residues to regulate, USDA is to
consider pesticides whose use on tobacco has been cancelled, suspended,
revoked, or otherwise prohibited under FIFRA. The regulation helps
ensure that domestic tobacco producers are not placed at an unfair
disadvantage in the market because they are not allowed to use certain
pesticides that may be used in other countries; it also helps protect
the public from exposure to the residues of highly toxic pesticides not
approved for use on tobacco in the United States.
While the focus of U.S. regulation of pesticide residues on tobacco is
on those pesticides not approved for use on tobacco, some other
countries have set limits on residues of pesticides that are used on
tobacco. Further, as in the United States, some countries limit the
concentration of residues as measured on tobacco leaf. However, at
least one country--Germany--limits the pesticide residues as measured
in cigarettes and other tobacco products. Appendix III provides
information on the limits established by Germany, Italy, and Spain.
USDA Has Not Reevaluated the Pesticides it Regulates Since 1989:
USDA has implemented the Dairy and Tobacco Adjustment Act, in part, by
setting 15 residue limits (maximum allowable concentrations) covering
20 pesticides currently not approved for use on tobacco in the United
States that the agency believed were used in other countries. Most of
the pesticides USDA regulates, such as DDT and toxaphene, are
organochlorine pesticides. As discussed earlier, organochlorine
pesticides persist in the environment and accumulate in the bodies of
humans and animals, and many are highly toxic--a number of them have
been banned for these reasons. Eleven of the 15 residue limits apply to
individual pesticides and 4 apply to 2 or more pesticides in
combination.[Footnote 36] For example, aldrin and dieldrin are summed
because dieldrin is the primary degradation product of aldrin. Table 5
lists the residue limits included in USDA's testing program, with the
12 organochlorine pesticides highlighted. As indicated in the table,
methoxychlor is the only organochlorine pesticide included in USDA's
testing program that is currently approved for other uses in the United
States, such as on food crops.
Table 5: USDA's Residue Limits for Pesticides on Tobacco:
Pesticide: (organochlorine pesticides in bold): 1. Chlordane; Residue
limit (parts per million): 3.0; Approved for nontobacco use(s): No.
Pesticide: (organochlorine pesticides in bold): 2.
Dibromochloropropane (DBCP); Residue limit (parts per million): 1.0;
Approved for nontobacco use(s): No.
Pesticide: (organochlorine pesticides in bold): 3. Dicamba; Residue
limit (parts per million): 5.0; Approved for nontobacco use(s): Yes.
Pesticide: (organochlorine pesticides in bold): 4. Endrin; Residue
limit (parts per million): 0.1; Approved for nontobacco use(s): No.
Pesticide: (organochlorine pesticides in bold): 5. Ethylene dibromide
(EDB); Residue limit (parts per million): 0.1; Approved for nontobacco
use(s): No.
Pesticide: (organochlorine pesticides in bold): 6. Formothion; Residue
limit (parts per million): 0.5; Approved for nontobacco use(s): No.
Pesticide: (organochlorine pesticides in bold): 7. Hexachlorobenzene
(HCB); Residue limit (parts per million): 0.1; Approved for nontobacco
use(s): No.
Pesticide: (organochlorine pesticides in bold): 8. Methoxychlor;
Residue limit (parts per million): 0.1; Approved for nontobacco use(s):
Yes.
Pesticide: (organochlorine pesticides in bold): 9. Toxaphene; Residue
limit (parts per million): 0.3; Approved for nontobacco use(s): No.
Pesticide: (organochlorine pesticides in bold): 10. 2,4-D; Residue
limit (parts per million): 5.0; Approved for nontobacco use(s): Yes.
Pesticide: (organochlorine pesticides in bold): 11. 2,4,5-T; Residue
limit (parts per million): 0.1; Approved for nontobacco use(s): Yes.
Pesticide: (organochlorine pesticides in bold): 12. Sum of aldrin and
dieldrin; Residue limit (parts per million): 0.1; Approved for
nontobacco use(s): No.
Pesticide: (organochlorine pesticides in bold): 13. Sum of cypermethrin
and permethrin; Residue limit (parts per million): 3.0; Approved for
nontobacco use(s): Yes.
Pesticide: (organochlorine pesticides in bold): 14. Sum of DDT, TDE,
and DDE; Residue limit (parts per million): 0.4; Approved for
nontobacco use(s): No.
Pesticide: (organochlorine pesticides in bold): 15. Sum of heptachlor
and heptachlor epoxide; Residue limit (parts per million): 0.1;
Approved for nontobacco use(s): No.
Source: 7 CFR 29.427, USDA, and EPA.
Note: GAO's analysis of EPA data.
[End of table]
USDA's Agricultural Marketing Service (AMS) initially established
maximum allowable concentrations of pesticides in August 1986 after
determining the countries from which the United States imports tobacco,
the pesticides that might reasonably be expected to be used on tobacco
in those countries, and the pesticides not approved for use in the
United States. In 1989, AMS revised the number of pesticides to its
current total of 20 residues.
Although in 1986 USDA stated its intent to periodically reevaluate the
pesticides it regulates, the department has not done so since 1989.
According to officials at USDA, reevaluating the regulated pesticide
residues has not been a priority of the department. However, since USDA
selected the pesticides it would test in 1989, tobacco uses have been
cancelled for more than 30 pesticides that had been approved for use on
tobacco.[Footnote 37] For example, by 2000, EPA had cancelled all
tobacco uses of lindane--a highly persistent, organochlorine pesticide
that may cause cancer and harm the environment. USDA does not currently
regulate pesticide residues of lindane because it was still approved
for tobacco when USDA last reevaluated the regulated pesticides. Other
pesticides, such as trichlorfon and diazinon, are also candidates for
regulation--that is, pesticides no longer approved for use on tobacco
in the United States but likely to be used in some other countries. As
appendix III shows, some countries that set limits for pesticides used
on tobacco have established them for trichlorfon and diazinon--one of
the leading causes of acute insecticide poisoning for humans. However,
because USDA has not revised the regulated pesticide residues it tests
for, the department's testing program may not include some pesticides
with characteristics similar to those of pesticides currently included
in the testing program and that may still be used in other countries.
Tobacco and pesticide experts with whom we spoke agreed that periodic
reevaluations of the regulated pesticides would be appropriate.
Furthermore, two of these experts--a toxicologist who has measured
residues on tobacco for many years and a former government official who
now represents tobacco producers--told us that many of the pesticides
USDA currently regulates, particularly the organochlorine pesticides,
warrant continued inclusion in the testing program because they are
persistent in the environment, accumulate in the body, and continue to
be used on crops overseas.
USDA Tests Imported and Domestic Tobacco for Regulated Pesticides:
Also as required by the Dairy and Tobacco Adjustment Act, USDA tests
certain imported and domestic tobacco to ensure that residues do not
exceed the maximum allowable concentrations the agency established.
USDA is required to test samples of two types of tobacco--flue-cured
and burley--that are commonly imported from other countries and also
produced in the United States to determine whether they conform to the
pesticide residue limits. These two types of tobacco are the major
components of cigarettes, and imports of them have continued to
increase over time. For example, USDA reported that imports of flue-
cured tobacco represented about 12 percent of the flue-cured tobacco
used in the United States in 1980 and about 36 percent in
2001.[Footnote 38] USDA is not required to test other types of imported
tobacco, such as oriental tobacco, which is added to cigarettes for
purposes of flavor and aroma but which is not grown in the United
States.
Tobacco is imported into the United States in large, sealed shipping
containers that hold approximately 40,000 pounds of tobacco in 90 to 96
boxes weighing about 440 pounds each. In 1986, AMS began testing
imported flue-cured and burley tobacco, which represented about
60 percent of the tobacco imported into the United States in 2001.
Random samples of imported flue-cured and burley tobacco are tested for
residues of the 20 regulated pesticides. AMS inspectors use a computer
program to randomly select one box of tobacco from each shipping
container. The domestic testing program began in 1989 and is
administered by the USDA Farm Service Agency (FSA)[Footnote 39] under a
cooperative agreement with AMS. Similar to the AMS program for tobacco
imports, FSA tests randomly selected samples of domestic flue-cured and
burley tobacco for the 20 regulated pesticides not approved for use in
the United States. FSA tests the portion of domestically grown flue-
cured and burley tobacco that becomes loan stock (surplus tobacco)
under USDA's tobacco price support program.[Footnote 40] The proportion
of domestic tobacco that becomes loan stock varies each year, depending
on tobacco quality and demand from manufacturers, and has declined in
recent years. Additional information about the domestic loan stock
program is provided in appendix IV.
For 1999 through 2001, USDA's testing programs found less than 1
percent of domestically produced or imported flue-cured and burley
tobacco with residue levels above the allowable levels.[Footnote 41]
According to agency officials, those results are consistent with
results obtained since testing began in 1986. More specifically, for
1999 through 2001, the FSA domestic testing program found a small
fraction of a percentage of domestically produced tobacco in excess of
the limits. FSA found 4 samples of flue-cured tobacco and 24 samples of
burley tobacco--representing more than 12,000 pounds of tobacco--that
exceeded the maximum allowable concentrations of 2 of the regulated
pesticides--methoxychlor and permethrin. AMS found residues of DDT/TDE/
DDE, cypermethrin, and ethylene dibromide in excess of the limits on
less than 1 percent of the imported tobacco entering the United States
during this time.
If imported tobacco exceeds any of the limits, the importer is notified
of the violation and may choose to appeal the result or reexport the
tobacco to another country. When an importer appeals, AMS inspectors
randomly select three additional samples for testing, and the residue
levels for the four samples are averaged. If the average result is
below the limits, the tobacco is cleared for entry into the United
States. However, if the average exceeds the limits, the container of
tobacco is denied entry and is typically reexported. Under the Dairy
and Tobacco Adjustment Act, domestically produced flue-cured or burley
tobacco not meeting the residue requirements must be destroyed.
According to USDA officials, because of restrictions on the disposition
of products contaminated by pesticides, boxes of domestic tobacco are
typically disposed of in an approved landfill with a permit from EPA.
Conclusions:
To ensure that pesticides can be used without posing an unreasonable
risk to human health, EPA conducts risk assessments of exposures to the
pesticides it evaluates for use in the United States, including
exposure to pesticide residues on tobacco. EPA's decision to limit its
quantitative assessment of the risks associated with pesticides on
tobacco to the effects of short-term exposure, and not include the
long-term exposure of smokers, recognizes that the pesticides are used
on a crop that itself poses very significant health risks to humans
through use in various consumer products--primarily cigarettes.
Overall, EPA's health risk assessments show that the pesticides used on
tobacco and other crops are probably a greater hazard for those who
handle them than for those who inhale tobacco smoke. Nonetheless, while
the risks of some exposures, such as acute poisoning, are clear, less
is known with certainty about the effects of long-term exposure to
small amounts of pesticides, such as residues in food and water, on
tobacco, or in the environment.
While historically EPA has required pesticide manufacturers to provide
data on the residues remaining on tobacco, its assessments of the
health effects associated with exposure to the residues were not
identified in risk assessment documents and generally were not
quantified. Mirroring the improvements in risk assessment methods in
recent years, EPA has adopted a more formal and consistent approach to
evaluating the health risks associated with pesticides used on tobacco
and has started to document, in its risk assessment documents, its
conclusions on the potential for short-term risks from pesticide
residues that may remain in tobacco smoke. As a result, interested
parties are better informed about the potential risks, and EPA is
appropriately more accountable for its assessments.
When used as intended--most commonly in cigarettes--tobacco is
generally inhaled into the body. However, because it is not a food,
tobacco is regulated as a nonfood crop with regard to pesticide
residues. That is, no residue limits are established or monitored for
pesticides approved for use on tobacco, as is done for foods. While the
regulation of pesticide residues on tobacco is limited because it does
not include pesticides approved for use on this crop, USDA tests
tobacco for residues of 20 pesticides not approved for domestic use on
tobacco, primarily for purposes of trade equity. Because many of the
tested pesticides are known to harm humans and the environment, the
USDA testing program helps minimize the public's exposure to some
highly toxic pesticides. The universe of pesticides not approved for
use on tobacco has grown since USDA selected the pesticides it tests,
but USDA has not reevaluated the program's coverage in 14 years. The
USDA testing program would be improved by assessing the current
universe of pesticides not approved for use on tobacco and determining
whether an update to its program is warranted.
Recommendation for Executive Action:
To better protect the public from exposures to residues of pesticides
not approved for use on tobacco in the United States and ensure that
domestic tobacco producers are not placed at an unfair disadvantage
relative to producers in other countries, we recommend that the
Secretary of the Department of Agriculture direct the Administrators of
the Agricultural Marketing Service and the Farm Service Agency to
periodically review and update the pesticides for which they set
residue limits and test imported and domestic tobacco.
Agency Comments:
We provided copies of our draft report to EPA and USDA for review and
comment. In commenting on the draft, EPA officials said we accurately
characterized the agency's risk assessment process for pesticides used
on tobacco, and USDA officials agreed with our recommendation to
periodically review and update the pesticides for which the department
sets residue limits and tests tobacco. USDA officials said they plan to
annually review and update the testing program for tobacco.
We conducted our review from May 2002 through March 2003 in accordance
with generally accepted government auditing standards. Our scope and
methodology are discussed in appendix I.
As agreed with your office, unless you publicly announce the contents
of this report earlier, we plan no further distribution until 30 days
from the report date. At that time we will send copies of this report
to the Administrator, EPA; the Secretary of Agriculture; and other
interested parties. We will make copies available to others upon
request. In addition, the report will be available at no charge on
GAO's Web site at http://www.gao.gov.
If you or your staff have any questions, please call me at (202) 512-
3841. Key contributors to this report are listed in appendix V.
Sincerely yours,
John B. Stephenson
Director, Natural Resources and Environment:
Signed by John B. Stephenson
[End of section]
Appendix I: Objectives, Scope, and Methodology:
This report provides information on (1) the pesticides commonly used on
tobacco and the potential health risks associated with them; (2) how
the Environmental Protection Agency (EPA) assesses and mitigates health
risks associated with pesticides used on tobacco; and (3) how, and the
extent to which, EPA, U.S. Department of Agriculture (USDA), and other
federal agencies regulate and monitor pesticide residues on tobacco. In
addition, this report provides information on the regulatory residue
limits adopted by three countries that are significant importers of
tobacco grown in the United States.
To identify the chemicals commonly used on tobacco, we reviewed
pesticide-use databases developed by the National Center for Food and
Agricultural Policy (NCFAP), a nonprofit research organization, under a
cooperative agreement with USDA. These databases summarized national
use of 235 pesticides on 87 food and nonfood crops for the period 1990
though 1998. These databases, compiled from more than 130 federal and
state surveys and reports, include pesticide use on cropland in the
coterminous 48 states and do not include new pesticides approved by EPA
since 1997. We also reviewed data from national surveys conducted in
the 1990s by the U.S. Geological Survey and USDA and from several
tobacco-producing states--Kentucky, North Carolina, Tennessee, and
Virginia. In total, 53 pesticides were identified as being used on
tobacco in one or more of the surveys. Of these, 37 were identified in
one or more of the surveys that included national data, and we refer to
this latter group as the pesticides that were commonly used on tobacco
in the United States during the 1990s. To identify the adverse health
effects associated with these 37 pesticides, we collected and reviewed
relevant human health risk assessments prepared by EPA's Office of
Pesticide Programs. Where such assessments were not available, we
reviewed documents from academic experts who maintain a database on
pesticides and other toxic chemicals for USDA, and other programs
within EPA. In addition we interviewed, and reviewed reports prepared
or recommended by, experts on the human health effects of exposure to
pesticides and other toxins at the National Cancer Institute, the
National Institute of Environmental Health Sciences, the National
Center for Environmental Health, Johns Hopkins Bloomberg School of
Public Health, and the Institute for Cancer Prevention (formerly the
American Health Foundation).
To determine how EPA assesses and mitigates potential health risks from
pesticide residues on tobacco, we reviewed agency policies and
procedures on identifying the levels of pesticide residues on tobacco
and the related health risks, and we interviewed EPA officials in the
Office of Pesticide Programs who perform these tasks. In addition, we
examined in detail how EPA implemented its policies and procedures for
13 of the 37 pesticides commonly used on tobacco. That is, we reviewed
pesticide residue studies submitted to EPA and EPA's evaluations of
pesticide residues and their potential health effects conducted as part
of the pesticide registration process under the Federal Insecticide,
Fungicide, and Rodenticide Act for 1,3-D, acephate, chlorpyrifos,
diazinon, disulfoton, endosulfan, ethoprop, ethephon, maleic
hydrazide, metalaxyl, methidathion, pebulate, and pendimethalin. We
focused primarily on those pesticides for which EPA had completed
registrations between 1994 and 2002. We did not independently evaluate
the validity or scientific merit of the studies that EPA relied upon to
reach its conclusions.
To determine the extent to which EPA, USDA, and other federal agencies
regulate and monitor pesticide residues on tobacco, we met with
cognizant officials and reviewed authorizing legislation, regulations,
and documentation on how programs related to pesticide residues on
tobacco are implemented. In addition, we analyzed USDA data on tobacco
production, imports, and residue-testing results. We also interviewed
academic and tobacco industry experts and reviewed residue data
collected by North Carolina State University.
To provide information on other countries that have adopted regulatory
limits on pesticide residues, we reviewed articles by academic experts
on the international regulation of pesticides on tobacco. We provide
information on three major importers of U.S. tobacco--Germany, Italy,
and Spain--as examples of regulatory approaches in other countries,
focusing on the residue limits they set. We did not examine how, or the
extent to which, these countries monitor or enforce their pesticide
residue limits. We updated and clarified the information on the three
countries' residue limits provided in the articles with information
from the Cooperation Centre for Scientific Research Relative to Tobacco
(CORESTA), an international tobacco research organization, and
officials responsible for oversight of pesticides and tobacco in
Germany and Spain. To identify countries that import U.S. tobacco, we
extracted data from the United States International Trade Commission's
interactive tariff and trade database on the countries that received
U.S. flue-cured and burley tobacco from 1996 through 2001.
We conducted our review from May 2002 through March 2003 in accordance
with generally accepted government auditing standards.
[End of section]
Appendix II: Pesticide Use on Tobacco and Other Crops:
Most of the pesticides used on tobacco are widely used on food and
other crops. As shown in table 6, tobacco use of most pesticides
represents a small portion of the total use. However, for some
pesticides--dimethomorph, fenamiphos, flumetralin, maleic hydrazide,
mefenoxam, and sulfentrazone--most of the use in 1994 through 1998 was
on tobacco.
Table 6: Pesticide Use on Tobacco and All Crops, 1990-98:
Pesticide: 1,3-dichloropropene (1,3-D); Use in pounds--1992 survey
(1990-93): Tobacco: 11,537,540; Use in pounds--1992 survey (1990-93):
All crops: 40,083,611; [Empty]; Use in pounds--1997 survey (1994-98):
Tobacco: 13,279,285; Use in pounds--1997 survey (1994-98): All crops:
34,717,237.
Pesticide: Chloropicrin; Use in pounds--1992 survey (1990-93): Tobacco:
577,082; Use in pounds--1992 survey (1990-93): All crops: 11,086,567;
[Empty]; Use in pounds--1997 survey (1994-98): Tobacco: 6,761,644; Use
in pounds--1997 survey (1994-98): All crops: 13,882,188.
Pesticide: Maleic hydrazide; Use in pounds--1992 survey (1990-93):
Tobacco: 1,789,208; Use in pounds--1992 survey (1990-93): All crops:
2,073,238; [Empty]; Use in pounds--1997 survey (1994-98): Tobacco:
1,790,089; Use in pounds--1997 survey (1994-98): All crops: 2,143,154.
Pesticide: Acephate; Use in pounds--1992 survey (1990-93): Tobacco:
1,570,457; Use in pounds--1992 survey (1990-93): All crops: 3,389,865;
[Empty]; Use in pounds--1997 survey (1994-98): Tobacco: 871,899; Use in
pounds--1997 survey (1994-98): All crops: 2,462,354.
Pesticide: Methyl bromide; Use in pounds--1992 survey (1990-93):
Tobacco: 5,356,748; Use in pounds--1992 survey (1990-93): All crops:
44,196,554; [Empty]; Use in pounds--1997 survey (1994-98): Tobacco:
685,026; Use in pounds--1997 survey (1994-98): All crops: 32,803,943.
Pesticide: Pendimethalin; Use in pounds--1992 survey (1990-93):
Tobacco: 321,931; Use in pounds--1992 survey (1990-93): All crops:
20,281,766; [Empty]; Use in pounds--1997 survey (1994-98): Tobacco:
473,718; Use in pounds--1997 survey (1994-98): All crops: 27,284,718.
Pesticide: Chlorpyrifos; Use in pounds--1992 survey (1990-93): Tobacco:
685,554; Use in pounds--1992 survey (1990-93): All crops: 14,764,535;
[Empty]; Use in pounds--1997 survey (1994-98): Tobacco: 406,822; Use in
pounds--1997 survey (1994-98): All crops: 13,463,879.
Pesticide: Fenamiphos; Use in pounds--1992 survey (1990-93): Tobacco:
257,142; Use in pounds--1992 survey (1990-93): All crops: 614,937;
[Empty]; Use in pounds--1997 survey (1994-98): Tobacco: 379,841; Use in
pounds--1997 survey (1994-98): All crops: 726,675.
Pesticide: Mancozeb; Use in pounds--1992 survey (1990-93): Tobacco: a;
Use in pounds--1992 survey (1990-93): All crops: 8,062,374; [Empty];
Use in pounds--1997 survey (1994-98): Tobacco: 356,811; Use in pounds-
-1997 survey (1994-98): All crops: 9,585,777.
Pesticide: Flumetralin; Use in pounds--1992 survey (1990-93): Tobacco:
a; Use in pounds--1992 survey (1990-93): All crops: a; [Empty]; Use in
pounds--1997 survey (1994-98): Tobacco: 352,742; Use in pounds--1997
survey (1994-98): All crops: 352,742.
Pesticide: Metalaxyl; Use in pounds--1992 survey (1990-93): Tobacco:
371,645; Use in pounds--1992 survey (1990-93): All crops: 855,400;
[Empty]; Use in pounds--1997 survey (1994-98): Tobacco: 271,368; Use in
pounds--1997 survey (1994-98): All crops: 659,997.
Pesticide: Clomazone; Use in pounds--1992 survey (1990-93): Tobacco:
[A]; Use in pounds--1992 survey (1990-93): All crops: 1,801,776;
[Empty]; Use in pounds--1997 survey (1994-98): Tobacco: 217,617; Use in
pounds--1997 survey (1994-98): All crops: 2,531,160.
Pesticide: Ethoprop; Use in pounds--1992 survey (1990-93): Tobacco:
438,274; Use in pounds--1992 survey (1990-93): All crops: 1,449,743;
[Empty]; Use in pounds--1997 survey (1994-98): Tobacco: 182,321; Use in
pounds--1997 survey (1994-98): All crops: 1,010,807.
Pesticide: Endosulfan; Use in pounds--1992 survey (1990-93): Tobacco:
a; Use in pounds--1992 survey (1990-93): All crops: 1,796,726; [Empty];
Use in pounds--1997 survey (1994-98): Tobacco: 172,766; Use in pounds-
-1997 survey (1994-98): All crops: 1,601,195.
Pesticide: Mefenoxam; Use in pounds--1992 survey (1990-93): Tobacco: a;
Use in pounds--1992 survey (1990-93): All crops: a; [Empty]; Use in
pounds--1997 survey (1994-98): Tobacco: 139,199; Use in pounds--1997
survey (1994-98): All crops: 210,101.
Pesticide: Pebulate; Use in pounds--1992 survey (1990-93): Tobacco:
412,000; Use in pounds--1992 survey (1990-93): All crops: 673,046;
[Empty]; Use in pounds--1997 survey (1994-98): Tobacco: 131,665; Use in
pounds--1997 survey (1994-98): All crops: 343,322.
Pesticide: Ethephon; Use in pounds--1992 survey (1990-93): Tobacco:
113,238; Use in pounds--1992 survey (1990-93): All crops: 2,701,284;
[Empty]; Use in pounds--1997 survey (1994-98): Tobacco: 102,130; Use in
pounds--1997 survey (1994-98): All crops: 5,407,986.
Pesticide: Napropamide; Use in pounds--1992 survey (1990-93): Tobacco:
191,840; Use in pounds--1992 survey (1990-93): All crops: 500,695;
[Empty]; Use in pounds--1997 survey (1994-98): Tobacco: 92,622; Use in
pounds--1997 survey (1994-98): All crops: 448,400.
Pesticide: Sulfentrazone; Use in pounds--1992 survey (1990-93):
Tobacco: a; Use in pounds--1992 survey (1990-93): All crops: a;
[Empty]; Use in pounds--1997 survey (1994-98): Tobacco: 69,073; Use in
pounds--1997 survey (1994-98): All crops: 69,073.
Pesticide: Imidacloprid; Use in pounds--1992 survey (1990-93): Tobacco:
a; Use in pounds--1992 survey (1990-93): All crops: a; [Empty]; Use in
pounds--1997 survey (1994-98): Tobacco: 67,896; Use in pounds--1997
survey (1994-98): All crops: 272,207.
Pesticide: Aldicarb; Use in pounds--1992 survey (1990-93): Tobacco:
159,044; Use in pounds--1992 survey (1990-93): All crops: 4,022,468;
[Empty]; Use in pounds--1997 survey (1994-98): Tobacco: 59,719; Use in
pounds--1997 survey (1994-98): All crops: 4,277,552.
Pesticide: Dimethomorph; Use in pounds--1992 survey (1990-93): Tobacco:
a; Use in pounds--1992 survey (1990-93): All crops: a; [Empty]; Use in
pounds--1997 survey (1994-98): Tobacco: 36,818; Use in pounds--1997
survey (1994-98): All crops: 51,536.
Pesticide: Methomyl; Use in pounds--1992 survey (1990-93): Tobacco:
57,137; Use in pounds--1992 survey (1990-93): All crops: 2,754,907;
[Empty]; Use in pounds--1997 survey (1994-98): Tobacco: 29,773; Use in
pounds--1997 survey (1994-98): All crops: 1,997,489.
Pesticide: Malathion; Use in pounds--1992 survey (1990-93): Tobacco:
7,549; Use in pounds--1992 survey (1990-93): All crops: 3,377,678;
[Empty]; Use in pounds--1997 survey (1994-98): Tobacco: 15,437; Use in
pounds--1997 survey (1994-98): All crops: 5,809,943.
Pesticide: Disulfoton; Use in pounds--1992 survey (1990-93): Tobacco:
52,578; Use in pounds--1992 survey (1990-93): All crops: 1,806,527;
[Empty]; Use in pounds--1997 survey (1994-98): Tobacco: 13,495; Use in
pounds--1997 survey (1994-98): All crops: 1,196,066.
Pesticide: Sethoxydim; Use in pounds--1992 survey (1990-93): Tobacco:
a; Use in pounds--1992 survey (1990-93): All crops: 1,350,566; [Empty];
Use in pounds--1997 survey (1994-98): Tobacco: 9,579; Use in pounds--
1997 survey (1994-98): All crops: 1,717,271.
Pesticide: Spinosad; Use in pounds--1992 survey (1990-93): Tobacco: a;
Use in pounds--1992 survey (1990-93): All crops: a; [Empty]; Use in
pounds--1997 survey (1994-98): Tobacco: 2,815; Use in pounds--1997
survey (1994-98): All crops: 117,315.
Pesticide: Carbaryl; Use in pounds--1992 survey (1990-93): Tobacco:
16,487; Use in pounds--1992 survey (1990-93): All crops: 4,570,414;
[Empty]; Use in pounds--1997 survey (1994-98): Tobacco: 2,057; Use in
pounds--1997 survey (1994-98): All crops: 4,857,542.
Pesticide: Fonofos; Use in pounds--1992 survey (1990-93): Tobacco:
12,798; Use in pounds--1992 survey (1990-93): All crops: 3,233,797;
[Empty]; Use in pounds--1997 survey (1994-98): Tobacco: 16; Use in
pounds--1997 survey (1994-98): All crops: 417,372.
Pesticide: Benefin; Use in pounds--1992 survey (1990-93): Tobacco:
56,963; Use in pounds--1992 survey (1990-93): All crops: 478,205;
[Empty]; Use in pounds--1997 survey (1994-98): Tobacco: a; Use in
pounds--1997 survey (1994-98): All crops: 161,983.
Pesticide: Bacillus thuringiensis; Use in pounds--1992 survey (1990-
93): Tobacco: b; Use in pounds--1992 survey (1990-93): All crops: b;
[Empty]; Use in pounds--1997 survey (1994-98): Tobacco: b; Use in
pounds--1997 survey (1994-98): All crops: b.
Pesticide: Carbofuran; Use in pounds--1992 survey (1990-93): Tobacco:
149,965; Use in pounds--1992 survey (1990-93): All crops: 5,101,406;
[Empty]; Use in pounds--1997 survey (1994-98): Tobacco: a; Use in
pounds--1997 survey (1994-98): All crops: 3,398,067.
Pesticide: Diazinon; Use in pounds--1992 survey (1990-93): Tobacco:
53,670; Use in pounds--1992 survey (1990-93): All crops: 1,265,739;
[Empty]; Use in pounds--1997 survey (1994-98): Tobacco: a; Use in
pounds--1997 survey (1994-98): All crops: 918,087.
Pesticide: Diphenamid; Use in pounds--1992 survey (1990-93): Tobacco:
81,624; Use in pounds--1992 survey (1990-93): All crops: 105,009;
[Empty]; Use in pounds--1997 survey (1994-98): Tobacco: a; Use in
pounds--1997 survey (1994-98): All crops: a.
Pesticide: Isopropalin; Use in pounds--1992 survey (1990-93): Tobacco:
129,287; Use in pounds--1992 survey (1990-93): All crops: 129,287;
[Empty]; Use in pounds--1997 survey (1994-98): Tobacco: a; Use in
pounds--1997 survey (1994-98): All crops: a.
Pesticide: Methidathion; Use in pounds--1992 survey (1990-93): Tobacco:
68; Use in pounds--1992 survey (1990-93): All crops: 372,953; [Empty];
Use in pounds--1997 survey (1994-98): Tobacco: a; Use in pounds--1997
survey (1994-98): All crops: 314,091.
Pesticide: Trichlorfon; Use in pounds--1992 survey (1990-93): Tobacco:
722; Use in pounds--1992 survey (1990-93): All crops: 13,974; [Empty];
Use in pounds--1997 survey (1994-98): Tobacco: a; Use in pounds--1997
survey (1994-98): All crops: a.
Pesticide: Grand total; Use in pounds--1992 survey (1990-93): Tobacco:
24,400,552; Use in pounds--1992 survey (1990-93): All crops:
182,915,047; [Empty]; Use in pounds--1997 survey (1994-98): Tobacco:
26,974,241; Use in pounds--1997 survey (1994-98): All crops:
175,211,229.
Source: National Center for Food and Agricultural Policy.
[A] Not identified as being used in survey.
[B] Neither survey estimated the use of Bacillus thuringiensis in
pounds.
[End of table]
[End of section]
Appendix III: Germany, Italy, and Spain Have Adopted Regulatory Limits
for Pesticide Residues on Tobacco:
Several countries that are major importers of U.S. tobacco have adopted
regulations for specific pesticide residues on various forms of
tobacco. For example, Germany's residue limits (maximum residue levels)
apply to finished products, such as cigarettes, whereas limits in Italy
and Spain generally apply to tobacco leaf. Although they have somewhat
different regulatory approaches to pesticides on tobacco, Germany,
Italy, and Spain differ from the United States in that they regulate
residues of pesticides approved for use on tobacco in addition to
regulating some residues of pesticides not approved for use on tobacco.
According to 2003 data from CORESTA--the Cooperation Centre for
Scientific Research Relative to Tobacco--Germany, Italy, and Spain have
residue limits on tobacco for 79, 100, and 58 pesticides,
respectively.[Footnote 42] Of the 37 pesticides commonly used on
tobacco in the United States during the 1990s, Germany has limits for
20, Italy for 24, and Spain for 21 (see table 7). None of these
countries have adopted limits for 7 of the pesticides commonly used on
U.S. tobacco during the 1990s.[Footnote 43]
Table 7: Residue Limits Adopted by Germany, Italy, and Spain
for Pesticides Commonly Used on Tobacco in the United States during the
1990s:
Pesticide: Acephate; Residue limits in ppm (country): Germany[A]: [D];
Residue limits in ppm (country): Italy[B]: 1.5; Residue limits in ppm
(country): Spain[C]: [D].
Pesticide: Aldicarb; Residue limits in ppm (country): Germany[A]: 10.0;
Residue limits in ppm (country): Italy[B]: 0.6 (green)
3.0 (cured); Residue limits in ppm (country): Spain[C]: 5.0.
Pesticide: Benefin; Residue limits in ppm (country): Germany[A]: [D];
Residue limits in ppm (country): Italy[B]: 0.01; Residue limits in ppm
(country): Spain[C]: 0.02.
Pesticide: Carbaryl; Residue limits in ppm (country): Germany[A]: 3.0;
Residue limits in ppm (country): Italy[B]: 3.0; Residue limits in ppm
(country): Spain[C]: 0.1.
Pesticide: Carbofuran; Residue limits in ppm (country): Germany[A]:
20.0; Residue limits in ppm (country): Italy[B]: 0.1; Residue limits in
ppm (country): Spain[C]: 10.0.
Pesticide: Chlorpyrifos; Residue limits in ppm (country): Germany[A]:
[D]; Residue limits in ppm (country): Italy[B]: 0.2; Residue limits in
ppm (country): Spain[C]: 0.05.
Pesticide: Diazinon; Residue limits in ppm (country): Germany[A]: 1.0;
Residue limits in ppm (country): Italy[B]: [D]; Residue limits in ppm
(country): Spain[C]: 0.02.
Pesticide: Dichloropropene; Residue limits in ppm (country):
Germany[A]: [D]; Residue limits in ppm (country): Italy[B]: [D];
Residue limits in ppm (country): Spain[C]: 0.05.
Pesticide: Diphenamid; Residue limits in ppm (country): Germany[A]:
1.5; Residue limits in ppm (country): Italy[B]: 0.1; Residue limits in
ppm (country): Spain[C]: 5.0.
Pesticide: Disulfoton; Residue limits in ppm (country): Germany[A]:
1.0; Residue limits in ppm (country): Italy[B]: 0.4; Residue limits in
ppm (country): Spain[C]: [D].
Pesticide: Endosulfan; Residue limits in ppm (country): Germany[A]:
20.0; Residue limits in ppm (country): Italy[B]: 1.0; Residue limits in
ppm (country): Spain[C]: [D].
Pesticide: Ethephon; Residue limits in ppm (country): Germany[A]: [D];
Residue limits in ppm (country): Italy[B]: 16.0 (green)
80.0 (cured); Residue limits in ppm (country): Spain[C]: [D].
Pesticide: Ethoprop; Residue limits in ppm (country): Germany[A]: 3.0;
Residue limits in ppm (country): Italy[B]: 0.02; Residue limits in ppm
(country): Spain[C]: 0.02.
Pesticide: Fenamiphos; Residue limits in ppm (country): Germany[A]:
15.0; Residue limits in ppm (country): Italy[B]: 0.1; Residue limits in
ppm (country): Spain[C]: 0.02.
Pesticide: Flumetralin; Residue limits in ppm (country): Germany[A]:
20.0; Residue limits in ppm (country): Italy[B]: 2.0 (green)
10.0 (cured); Residue limits in ppm (country): Spain[C]: 5.0.
Pesticide: Fonophos; Residue limits in ppm (country): Germany[A]: 1.0;
Residue limits in ppm (country): Italy[B]: 0.05; Residue limits in ppm
(country): Spain[C]: [D].
Pesticide: Imidacloprid; Residue limits in ppm (country): Germany[A]:
[D]; Residue limits in ppm (country): Italy[B]: 10.0 (green)
50.0 (cured); Residue limits in ppm (country): Spain[C]: 5.0.
Pesticide: Isopropalin; Residue limits in ppm (country): Germany[A]:
0.5; Residue limits in ppm (country): Italy[B]: 0.02; Residue limits in
ppm (country): Spain[C]: [D].
Pesticide: Malathion; Residue limits in ppm (country): Germany[A]: 3.0;
Residue limits in ppm (country): Italy[B]: 0.5; Residue limits in ppm
(country): Spain[C]: 0.5.
Pesticide: Maleic hydrazide; Residue limits in ppm (country):
Germany[A]: 80.0; Residue limits in ppm (country): Italy[B]: 80.0[A];
Residue limits in ppm (country): Spain[C]: 80.0.
Pesticide: Mancozeb; Residue limits in ppm (country): Germany[A]:
50.0[E]; Residue limits in ppm (country): Italy[B]: 2.0 (green)
10.0[F] (cured); Residue limits in ppm (country): Spain[C]: 0.05[G].
Pesticide: Metalaxyl; Residue limits in ppm (country): Germany[A]: [D];
Residue limits in ppm (country): Italy[B]: 1.0; Residue limits in ppm
(country): Spain[C]: 3.0.
Pesticide: Methidathion; Residue limits in ppm (country): Germany[A]:
1.0; Residue limits in ppm (country): Italy[B]: [D]; Residue limits in
ppm (country): Spain[C]: [D].
Pesticide: Methomyl; Residue limits in ppm (country): Germany[A]: 2.0;
Residue limits in ppm (country): Italy[B]: [D]; Residue limits in ppm
(country): Spain[C]: [D].
Pesticide: Methyl bromide; Residue limits in ppm (country): Germany[A]:
[D]; Residue limits in ppm (country): Italy[B]: [D]; Residue limits in
ppm (country): Spain[C]: 20.0.
Pesticide: Napropamide; Residue limits in ppm (country): Germany[A]:
0.1; Residue limits in ppm (country): Italy[B]: 0.1; Residue limits in
ppm (country): Spain[C]: 0.05.
Pesticide: Pebulate; Residue limits in ppm (country): Germany[A]: 0.5;
Residue limits in ppm (country): Italy[B]: [D]; Residue limits in ppm
(country): Spain[C]: 0.05.
Pesticide: Pendimethalin; Residue limits in ppm (country): Germany[A]:
[D]; Residue limits in ppm (country): Italy[B]: 0.05; Residue limits in
ppm (country): Spain[C]: 0.05.
Pesticide: Sethoxydim; Residue limits in ppm (country): Germany[A]:
[D]; Residue limits in ppm (country): Italy[B]: 0.5; Residue limits in
ppm (country): Spain[C]: [D].
Pesticide: Trichlorfon; Residue limits in ppm (country): Germany[A]:
1.0; Residue limits in ppm (country): Italy[B]: 0.1; Residue limits in
ppm (country): Spain[C]: 0.1.
Pesticide: Number of limits for commonly used pesticides; Residue
limits in ppm (country): Germany[A]: 20; Residue limits in ppm
(country): Italy[B]: 24; Residue limits in ppm (country): Spain[C]: 21.
Source: CORESTA and European Court of Auditors.
Note: GAO's analysis of CORESTA and European Court of Auditors data.
[A] Residue limit on finished products.
[B] Residue limit on green tobacco if not otherwise specified.
[C] Residue limit on dried tobacco.
[D] Country has not adopted limits for this pesticide.
[E] Residue limit established for the entire class of dithiocarbamates
except metam.
[F] Residue limit established for the entire class of dithiocarbamates
except thiram.
[G] Residue limit established for the entire class of dithiocarbamates
except metam and thiram.
[End of table]
In addition to residue limits for approved pesticides, Germany and
Italy collectively have residue limits on tobacco that apply to 15 of
the 20 pesticides not approved for use in the United States that USDA
monitors in its tobacco testing programs. The 15 pesticides are aldrin,
dieldrin, chlordane, cypermethrin, DDT, DDE, endrin, ethylene
dibromide, formothion, heptachlor, heptachlor epoxide,
hexachlorobenzene, methoxychlor, permethrin, and TDE. Further, where no
specific pesticide limits are set for tobacco products in Germany,
residues of pesticides not approved for use on tobacco in Germany may
be present in amounts that are not likely to pose a risk to human
health. In Italy and Spain, residues of pesticides not approved for use
on tobacco in those countries must not exceed the limit of detection,
generally between 0.01 ppm and 0.05 ppm. We did not examine how, or the
extent to which, these countries monitor or enforce their pesticide
residue limits.
From 1971 to 2000, researchers at the North Carolina State University
(NCSU) collected limited data on the residues of various pesticides on
some domestically grown tobacco. NCSU data for the 1990s included six
pesticides for which Germany, Italy, or Spain have residue limits. The
domestic tobacco tested by NCSU identified residue levels that were
(1) consistently below the lowest limit for endosulfan, flumetralin,
and metalaxyl; (2) generally above the limit for maleic
hydrazide;[Footnote 44] and (3) more varied for fenamiphos and the
dithiocarbamates--a class of fungicides that includes mancozeb. For
example, in 1995 residue levels on flue-cured tobacco were below the
lowest limit for fenamiphos--0.02 ppm adopted by Spain--but exceeded
this limit in 1992 and 1994. Also, in 1991 and 1997 residue levels of
dithiocarbamates were generally lower on burley tobacco than limits in
Germany and Italy--50 ppm and 10 ppm, respectively--but exceeded
Spain's limit of 0.05 ppm.
[End of section]
Appendix IV: USDA Tests Domestic Tobacco in the Loan Stock Program:
The USDA Farm Service Agency (FSA)[Footnote 45] tests the portion of
domestically grown flue-cured and burley tobacco that becomes loan
stock (surplus tobacco) under USDA's tobacco price support program for
the 20 regulated pesticides.[Footnote 46] To receive price supports,
tobacco must be sold in USDA-approved auction warehouses and inspected
by USDA graders. At the auction warehouse, each individual lot of
tobacco is sold to the highest bidder. If the highest bid is below the
government's loan (support) price, or no bid is received, the
stabilization cooperative makes loans to growers whose tobacco does not
bring the minimum price at auction with funds borrowed from USDA's
Commodity Credit Corporation. The growers' tobacco, which is consigned
to the cooperative as loan stock, is pledged as collateral to the
credit corporation for the money borrowed. The cooperative receives,
processes, stores, and later sells the loan stock tobacco when demand
increases, with the proceeds used to repay the credit corporation loan,
plus interest. An alternative to traditional auction marketing--growers
contracting to sell their tobacco directly to manufacturers--also
reduces the amount of tobacco going to auction and thus potentially to
loan stock. For the most recently completed marketing season--growing
year 2001--20 percent of domestic tobacco was sold at auction, and 2.4
percent became loan stock.
After auction, the tobacco is processed in distinct "runs" of
approximately 100,000 pounds, when the tobacco is stemmed, redried,
finely chopped, and placed into boxes holding approximately 440 pounds.
The tobacco cooperative randomly selects one box from each run and
draws a one-pound sample of tobacco for pesticide testing at USDA's
laboratory. If the sample exceeds any of the residue limits, the box of
tobacco from which it came is destroyed. The adjacent boxes, processed
before and after the original box, are also sampled. The testing
continues with adjacent boxes of tobacco until the samples are found to
be below the residue limits. Because the samples are drawn by the
tobacco cooperatives, FSA resamples 5 percent of the tested inventory
(or 25 samples, whichever is less) for oversight purposes each year.
Historically a substantial portion of domestic tobacco was sold at
auctions in conjunction with the tobacco price support program, but in
recent years most domestic tobacco has been sold under contract
directly to cigarette manufacturers--approximately 80 percent in 2001.
Officials from USDA and tobacco associations told us the market has
changed because manufacturers asserted that auction markets were not
providing quality tobacco with the characteristics they required. The
recent, dramatic shift in the way tobacco is marketed--with a 60 to 80
percent reduction in the amount of tobacco at auction--has decreased
the amount of domestic tobacco that potentially becomes loan stock and
thus is tested. Although the amount of domestically produced tobacco
that becomes loan stock has varied greatly, an average of 13 percent
became loan stock over the past decade. In 2001, only about 2 percent
of domestically produced tobacco has become loan stock, reducing the
amount of domestic tobacco subjected to pesticide testing. The
officials with whom we spoke said that this change is not likely to be
reversed.
[End of section]
Appendix V: GAO Contacts and Staff Acknowledgments:
GAO Contacts:
John B. Stephenson, (202) 512-3841
Christine Fishkin, (202) 512-6895:
Acknowledgments:
In addition to those named above, Nancy Crothers, Laura Gatz, Terrance
Horner, Richard Johnson, Ilga Semeiks, Tina Smith, and Cheryl Williams
made key contributions to this report.
FOOTNOTES
[1] This report generally uses the term "pesticide" to refer to the
toxic compounds, also called active ingredients, that are contained in
pesticide products. Pesticide products typically include at least one
active ingredient as well as inert ingredients.
[2] Dichlorodiphenyltrichloroethane, known as DDT, was one of the most
widely used chemicals for controlling insect pests on crops after 1945.
Under the authority of EPA, all registrations of DDT have been
cancelled, prohibiting the use of the pesticide in the United States.
[3] The 14 other states are Connecticut, Florida, Georgia, Indiana,
Maryland, Massachusetts, Missouri, Ohio, Pennsylvania, South Carolina,
Tennessee, Virginia, West Virginia, and Wisconsin.
[4] In addition to tobacco, cigarettes contain other ingredients
(additives) to enhance flavor and other qualities of the product.
[5] Typically, applicants for pesticide registrations are the
manufacturers; EPA calls the applicants "registrants."
[6] The National Center for Food and Agricultural Policy, a private
nonprofit, nonadvocacy research organization, conducted two key surveys
for USDA covering the periods 1990-93 (called the 1992 survey) and
1994-98 (called the 1997 survey). See appendix I for more detail on
these surveys.
[7] In this report, the term "insecticide" includes pesticides used to
control insects, spiders, and nematodes (worms).
[8] During the 1990s, EPA cancelled tobacco use for approximately 34
pesticides.
[9] When EPA cancels the use of a pesticide, the pesticide is typically
phased out over time.
[10] One reason manufacturers may choose to request cancellation of
pesticide registrations is to avoid costs associated with reregistering
pesticides for each use, such as the cost of providing EPA with data
and studies.
[11] EPA's efforts to phase out the use of methyl bromide in the 1990s
were consistent with international efforts to curtail its use under the
Montreal Protocol, a treaty signed by over 160 countries to control the
production and trade of ozone-depleting substances globally.
[12] EPA will assess the health effects of carbofuran in fiscal year
2003 during its reregistration review.
[13] EPA has requested data to assess the potential of trichlorfon,
which is no longer approved for use on tobacco, to cause birth defects
and has terminated its assessment of fonofos because all uses of the
pesticide were cancelled.
[14] One herbicide, clomazone, has not been classified chemically.
[15] The body's endocrine system produces hormones that help guide the
development, growth, reproduction, and behavior of animals, including
humans. Some chemicals can interfere with the normal function of this
complex system in ways that mimic a natural hormone, thereby fooling
the body into overresponding to a hormone or blocking the effects of a
hormone. Others may directly stimulate or inhibit the endocrine system,
leading to overproduction or underproduction of hormones. Certain drugs
are used to intentionally cause some of these effects, such as birth
control pills.
[16] EPA requires metabolism studies to identify by-products of
pesticides that are of toxicological concern or that account for 10
percent or more of the total radioactive residues. (For metabolism
studies, the pesticides have had radioactive atoms attached to their
molecular structure to allow tracking of the pesticide through the
plant.)
[17] The results of metabolism studies on food crops may be used to
determine the identity of the residues of concern.
[18] EPA does not use the tiered approach to analyze pesticide residues
on food and feed crops. Instead, it generally requires data on how the
plants metabolize the pesticide and studies of residues that remain at
the time of harvest (field trials), and, in some cases, as the food is
processed.
[19] EPA's conclusion is based on its analysis, which compared its
threshold (0.1 ppm) with residue levels at which inhalation exposure to
other pesticide residues produces no harmful effects. Specifically, the
0.1-ppm threshold represents an estimated actual exposure to pesticide
residues equivalent to half of the lowest residue level that EPA
officials know of for inhalation exposure that does not produce adverse
effects.
[20] Prior to 1999, the determination of the methodology and
assumptions for assessing the risk to smokers of pesticide residues on
tobacco was left to the discretion of individual toxicologists, who
made independent determinations for each chemical based on what they
considered to be reasonable assumptions. Quantitative risk assessments
generally were not performed. This new policy was formalized as
guidance in August 2000 and is available electronically to EPA's risk
assessors as part of the Health Effects Division's Risk Science
Assessment Review Committee Library.
[21] Pierce, J.P., et al., 1989. Tobacco Use in 1986 - Methods and
Basic Tabulations from Adult Use of Tobacco Survey. U.S. Department of
Health and Human Services Publication Number OM90-2004. Office on
Smoking and Health, Rockville, Maryland.
[22] U.S. General Accounting Office, Pesticides: Improvements Needed to
Ensure the Safety of Farmworkers and Their Children, GAO/RCED-00-40
(Washington, D.C.: Mar. 14, 2000) and Pesticides: Use, Effects, and
Alternatives to Pesticides in Schools, GAO/RCED-00-17 (Washington,
D.C.: Nov. 29, 1999).
[23] The 13 pesticides are 1,3-D, acephate, chlorpyrifos, diazinon,
disulfoton, endosulfan, ethoprop, ethephon, maleic hydrazide,
metalaxyl, methidathion, pebulate, and pendimethalin.
[24] The 11 states where 1,3-D cannot be used are Maine, Massachusetts,
Minnesota, Montana, New Hampshire, New York, North Dakota, South
Dakota, Utah, Vermont, and Wisconsin.
[25] The 1997 survey estimated that, of the 37 pesticides used on
tobacco in the 1990s, 12 were applied to tobacco in amounts less than
100,000 pounds and 8 were shown as not used during this survey (1994-
98). See appendix II for more detail on the estimated amounts of
pesticides used on tobacco.
[26] Although 1,3-D is also widely used on soils where food crops are
planted, EPA does not require that food use tolerances be established
for this pesticide because no residues remain on plants grown in
treated soil.
[27] Chlorpyrifos is currently registered to control foliage-borne and
soil-borne pests on food and feed crops; at golf courses; and on
nonstructural wood, such as utility poles and fence posts, as well as
to kill adult mosquitoes. Structural treatments for termites are also
registered uses but are being phased out by the end of 2005.
[28] EPA determined that endosulfan can be used on tobacco in only 6 of
the 16 states where it is grown--Indiana, Kentucky, Ohio, Pennsylvania,
Tennessee, and West Virginia--which account for about 40 percent of
domestic production.
[29] Of the 13 pesticides we reviewed, all of the currently approved
products containing 1,3-D, disulfoton, and ethoprop are restricted use
products, and some of the products containing chlorpyrifos are
restricted use products.
[30] In June 2002, EPA issued a preliminary cumulative risk assessment
for organophosphates for public comment. The agency, in consultation
with scientific advisors, will revise the assessment on the basis of
comments and data that were submitted. No date has been set to issue
the final cumulative risk assessment for organophosphate pesticides.
[31] Maleic hydrazide and metalaxyl.
[32] EPA issued the reregistration decision for this pesticide,
metalaxyl, in 1994. EPA officials said they would no longer substitute
a rat inhalation study for a pyrolysis study. Researchers found no
difference between rats exposed to smoke containing metalaxyl residues
and those that were not.
[33] The other 6 registration decisions were issued prior to the 1999
guidance.
[34] In addition, EPA does not require validation by an independent
laboratory of the analytic method used to measure pesticide residues on
nonfood crops as it does for methods used to measure pesticide residues
on food and feed. The purpose of the external validation is to support
enforcement of tolerances by ensuring that competent analysts can apply
the method used.
[35] 7 U.S.C. 511r.
[36] USDA's method of measuring residues is consistent with EPA's and
FDA's.
[37] Not including the cancelled pesticides, about 100 pesticides had
approval for tobacco uses in the 1990s.
[38] USDA Economic Research Service U.S. Tobacco Import Update (TBS-
2002-02), Feb. 2003.
[39] FSA was formed in 1994 from programs in several agencies,
including tobacco programs from the former Agricultural Stabilization
and Conservation Service.
[40] The price support program is administered by stabilization
cooperatives--owned by tobacco growers--under agreement with USDA's
Commodity Credit Corporation and auction warehouses.
[41] Imported tobacco percentage calculated by weight of imported flue-
cured and burley tobacco; domestic percentage calculated by weight of
flue-cured and burley loan stock.
[42] CORESTA is an international research association whose members are
companies and research institutes having research and development
activities related to tobacco. It has 190 members from 52 countries.
[43] The seven pesticides are Bacillus thuringiensis, chloropicrin,
clomazone, dimethomorph, mefanoxam, spinosad, and sulfentrazone.
[44] According to tobacco experts with whom we spoke, tobacco with high
levels of maleic hydrazide may be blended with tobacco from other
sources to reduce overall maleic hydrazide levels.
[45] FSA was formed in 1994 from programs in several agencies,
including tobacco programs from the former Agricultural Stabilization
and Conservation Service.
[46] The price support program is administered by stabilization
cooperatives--owned by tobacco growers--under agreement with USDA's
Commodity Credit Corporation and auction warehouses.
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