oversight

Pesticides on Tobacco: Federal Activities to Assess Risks and Monitor Residues

Published by the Government Accountability Office on 2003-03-26.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

             United States General Accounting Office

GAO          Report to the Ranking Minority
             Member, Committee on Government
             Reform, House of Representatives


March 2003
             PESTICIDES ON
             TOBACCO
             Federal Activities to
             Assess Risks and
             Monitor Residues




GAO-03-485
                                               March 2003


                                               PESTICIDES ON TOBACCO

                                               Federal Activities to Assess Risks and
Highlights of GAO-03-485, a report to the
Ranking Minority Member, Committee on          Monitor Residues
Government Reform, House of
Representatives




Pesticides play a significant role in          In the 1990s, domestic growers commonly used 37 pesticides approved
increasing production of tobacco,              for use on tobacco by EPA. Most of these pesticides were also used on
food, and other crops by reducing              food crops. When used in ways that deviate from conditions set by EPA,
the number of crop-destroying
pests. However, if used
                                               many of these pesticides can cause moderate to severe respiratory and
improperly, pesticides can have                neurological damage—and may result in death. Moreover, animal studies
significant adverse health effects.            suggest that some of these pesticides may cause birth defects or cancer.
GAO was asked to (1) identify the
pesticides commonly used on                    Under its pesticide registration program, EPA evaluates toxicity and
tobacco crops and the potential                other data to assess health risks to workers and the public from exposure
health risks associated with them,             to pesticides—and risks to smokers from exposure to residues in smoke.
(2) determine how the
                                               These assessments have identified a range of risks that required such
Environmental Protection Agency
(EPA) assesses and mitigates                   mitigation as limiting where and how the pesticide may be used,
health risks associated with                   prohibiting use in certain states, and requiring workers to wear
pesticides used on tobacco, and                respirators and chemical-resistant clothing. On the other hand, EPA has
(3) assess the extent to which                 concluded that low levels of residues in tobacco smoke do not pose
federal agencies regulate and test             short-term health concerns requiring mitigation. EPA does not assess
for pesticide residues on tobacco.             intermediate or long-term risks to smokers because of the severity of
                                               health effects linked to use of tobacco products themselves.

GAO recommends that the                        While EPA regulates the specific pesticides that may be used on tobacco
Secretary of the Department of                 and other crops and specifies how the pesticides may be used, it does not
Agriculture direct the                         otherwise regulate residues of pesticides approved for use on tobacco.
Administrators of the Agricultural             USDA, however, is required by the Dairy and Tobacco Adjustment Act to
Marketing Service and the Farm
Service Agency to periodically
                                               test imported and domestic tobacco for residues of pesticides not
review and update the pesticides               approved by EPA for use on tobacco that federal officials believe are
on tobacco for which they set                  used in other countries. By helping ensure that other countries do not
residue limits and test imported               use highly toxic pesticides that U.S. tobacco growers may not use,
and domestic tobacco.                          federal regulation of pesticide residues on tobacco addresses trade
                                               equity as well as health and environmental issues. However, USDA has
Commenting on a draft of this                  not reevaluated the list of pesticides for which it tests since 1989, even
report, EPA officials said GAO
                                               though EPA has cancelled tobacco use for over 30 pesticides since then.
accurately characterized the
agency’s risk assessment process
for pesticides used on tobacco, and            USDA Inspectors Take a Tobacco Sample for Laboratory Testing
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.
Contents


Letter                                                                                    1
               Results in Brief                                                           2
               Background                                                                 4
               Pesticides Commonly Used on Tobacco Have Potential Short- and
                 Long-Term Adverse Health Effects                                         7
               EPA Concludes that Health Risks of Pesticide Residues on
                 Tobacco Are Minimal but Requires Mitigation for Risks from
                 Other Exposures                                                        14
               Federal Regulation of Pesticide Residues on Tobacco Is Limited           26
               Conclusions                                                              32
               Recommendation for Executive Action                                      33
               Agency Comments                                                          33

Appendix I     Objectives, Scope, and Methodology                                       35



Appendix II    Pesticide Use on Tobacco and Other Crops                                 37



Appendix III   Germany, Italy, and Spain Have Adopted Regulatory
               Limits for Pesticide Residues on Tobacco                                 39



Appendix IV    USDA Tests Domestic Tobacco in the Loan Stock
               Program                                                                  42



Appendix V     GAO Contacts and Staff Acknowledgments                                   44



Tables
               Table 1: Pesticides Commonly Used on Domestic Tobacco, 1990-98             8
               Table 2: Pesticide Use on Tobacco, 1990-98                                 9
               Table 3: Organochlorine, Organophosphate, and Carbamate
                        Pesticides Commonly Used on Tobacco in the 1990s                11
               Table 4: Margins of Exposure for Five Pesticides Approved for Use
                        on Tobacco                                                      26
               Table 5: USDA’s Residue Limits for Pesticides on Tobacco                 29


               Page i                                      GAO-03-485 Pesticides on Tobacco
         Table 6: Pesticide Use on Tobacco and All Crops, 1990-98                 37
         Table 7: Residue Limits Adopted by Germany, Italy, and Spain for
                  Pesticides Commonly Used on Tobacco in the United
                  States during the 1990s                                         39


Figure
         Figure 1: EPA’s Tiered Approach to Assessing Health Risks of
                  Exposure to Residues on Tobacco                                 17




         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


         Page ii                                     GAO-03-485 Pesticides on Tobacco
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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Page iii                                               GAO-03-485 Pesticides on Tobacco
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.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.




                                   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.



                                   Page 1                                                  GAO-03-485 Pesticides on Tobacco
                   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.


                   Surveys conducted during the 1990s indicate that tobacco producers in the
Results in Brief   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


                   Page 2                                        GAO-03-485 Pesticides on Tobacco
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.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


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.




Page 3                                                  GAO-03-485 Pesticides on Tobacco
             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.


             Tobacco is a high-value, pesticide-intensive crop. That is, tobacco is the
Background   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.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.4




             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.




             Page 4                                                  GAO-03-485 Pesticides on Tobacco
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


Page 5                                        GAO-03-485 Pesticides on Tobacco
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.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



5
 Typically, applicants for pesticide registrations are the manufacturers; EPA calls the
applicants “registrants.”




Page 6                                                   GAO-03-485 Pesticides on Tobacco
                        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.


                        According to federally sponsored surveys, during the 1990s tobacco
Pesticides Commonly     producers in the United States commonly used 37 of the pesticides
Used on Tobacco         approved by EPA for such use.6 As shown in table 1, most of the pesticides
                        used on tobacco were insecticides and herbicides, which control insect
Have Potential Short-   and plant pests; others were fungicides, which combat fungal diseases, or
and Long-Term           plant growth regulators; and a few had more than one use.7
Adverse Health
Effects




                        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).




                        Page 7                                                    GAO-03-485 Pesticides on Tobacco
Table 1: Pesticides Commonly Used on Domestic Tobacco, 1990-98

    Primary use(s)                                    Pesticide
    Insecticide                                       Acephate, aldicarb, Bacillus thuringiensis, carbaryl,
                                                      carbofuran, chlorpyrifos, diazinon, disulfoton,
                                                      endosulfan, ethoprop, fenamiphos, fonofos,
                                                      imidacloprid, malathion, methidathion, methomyl,
                                                      spinosad, trichlorfon
    Herbicide                                         Benefin, clomazone, diphenamid, isopropalin,
                                                      napropamide, pebulate, pendimethalin, sethoxydim,
                                                      sulfentrazone
    Fungicide                                         Dimethomorph, mancozeb, mefenoxam, metalaxyl
    Plant growth regulator                            Ethephon, flumetralin
    Plant growth regulator, herbicide                 Maleic hydrazide
    Fumigant, insecticide                             Chloropicrin
    Fumigant, insecticide, herbicide                  Methyl bromide
    Fungicide, insecticide, herbicide                 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.


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.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.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



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.




Page 8                                                                           GAO-03-485 Pesticides on Tobacco
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,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.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

                                  Pounds used on tobacco          Pounds used on tobacco
 Pesticide                          1992 survey (1990-93)           1997 survey (1994-98)
 1,3-dichloropropene (1,3-D)                   11,537,540                      13,279,285
 Chloropicrin                                     577,082                       6,761,644
 Maleic hydrazide                               1,789,208                       1,790,089
 Acephate                                       1,570,457                         871,899
 Methyl bromide                                 5,356,748                         685,026
 Pendimethalin                                    321,931                         473,718
 Chlorpyrifos                                     685,554                         406,822
 Fenamiphos                                       257,142                         379,841
                                                              a
 Mancozeb                                                                         356,811
                                                              a
 Flumetralin                                                                      352,742
 Metalaxyl                                            371,645                     271,368
                                                              a
 Clomazone                                                                        217,617
 Ethoprop                                             438,274                     182,321
                                                              a
 Endosulfan                                                                       172,766
                                                              a
 Mefenoxam                                                                        139,199
 Pebulate                                            412,000                      131,665
 Ethephon                                            113,238                      102,130



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.




Page 9                                                   GAO-03-485 Pesticides on Tobacco
                                                 Pounds used on tobacco    Pounds used on tobacco
    Pesticide                                      1992 survey (1990-93)     1997 survey (1994-98)
    Napropamide                                                  191,840                    92,622
                                                                       a
    Sulfentrazone                                                                           69,073
                                                                       a
    Imidacloprid                                                                            67,896
    Aldicarb                                                    159,044                     59,719
                                                                       a
    Dimethomorph                                                                            36,818
    Methomyl                                                     57,137                     29,773
    Malathion                                                     7,549                     15,437
    Disulfoton                                                   52,578                     13,495
                                                                       a
    Sethoxydim                                                                               9,579
                                                                       a
    Spinosad                                                                                 2,815
    Carbaryl                                                     16,487                      2,057
    Fonofos                                                      12,798                         16
                                                                                                   a
    Benefin                                                      56,963
                                                                       b                           b
    Bacillus thuringiensis
                                                                                                   a
    Carbofuran                                                   149,965
                                                                                                   a
    Diazinon                                                      53,670
                                                                                                   a
    Diphenamid                                                    81,624
                                                                                                   a
    Isopropalin                                                  129,287
                                                                                                   a
    Methidathion                                                      68
                                                                                                   a
    Trichlorfon                                                      722
    Total used on tobacco                                     24,400,552                 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.


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).




Page 10                                                             GAO-03-485 Pesticides on Tobacco
Table 3: Organochlorine, Organophosphate, and Carbamate Pesticides Commonly
Used on Tobacco in the 1990s

 Chemical class                Pesticide name
 Organochlorine                Endosulfan
 Organophosphate               Acephate, chlorpyrifos, diazinon, disulfoton, ethoprop, fenamiphos,
                               fonofos, malathion, methidathion, trichlorfon
 Carbamate                     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.


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.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



12
 EPA will assess the health effects of carbofuran in fiscal year 2003 during its
reregistration review.




Page 11                                                                    GAO-03-485 Pesticides on Tobacco
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.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



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.




Page 12                                                 GAO-03-485 Pesticides on Tobacco
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.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.




14
 One herbicide, clomazone, has not been classified chemically.




Page 13                                               GAO-03-485 Pesticides on Tobacco
                            To determine whether the use of individual pesticides can reasonably be
EPA Concludes that          expected not to harm human health, EPA conducts health risk
Health Risks of             assessments under its pesticide registration program. These risk
                            assessments are based on EPA’s evaluations of the results of numerous
Pesticide Residues on       scientific studies and tests that the agency requires pesticide
Tobacco Are Minimal         manufacturers to carry out. EPA also assesses the health risks to smokers
                            from exposure to pesticides used on tobacco by analyzing data on their
but Requires                toxicity and the residue levels that remain on tobacco and in tobacco
Mitigation for Risks        smoke. Because pesticides are used extensively on crops, including
from Other Exposures        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   Under its pesticide registration program, EPA routinely assesses the health
of Varied Exposures to      risks of exposure to pesticides from residues in drinking water and food
Pesticides                  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




                            Page 14                                        GAO-03-485 Pesticides on Tobacco
with the body’s endocrine system.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-products16 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,



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.)




Page 15                                                GAO-03-485 Pesticides on Tobacco
depending upon the amount of residues that are identified.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.




17
  The results of metabolism studies on food crops may be used to determine the identity of
the residues of concern.




Page 16                                                GAO-03-485 Pesticides on Tobacco
Figure 1: EPA’s Tiered Approach to Assessing Health Risks of Exposure to
Residues on Tobacco




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).




Page 17                                                       GAO-03-485 Pesticides on Tobacco
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.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.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.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



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.




Page 18                                                   GAO-03-485 Pesticides on Tobacco
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 day21 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.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


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).




Page 19                                               GAO-03-485 Pesticides on Tobacco
                                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        EPA’s health risk assessments have identified a number of potential
Associated with Pesticide       adverse health effects associated with the pesticides used on tobacco and
Use Can Be Significant, but     other crops that, in some cases, have led the agency to impose special
                                limitations on the uses of these pesticides. The risks that required
Those Associated with           mitigation stemmed from (1) potential exposure of workers who apply
Pesticide Residues on           pesticides or harvest crops and (2) potential exposure of the general
Tobacco Appear to Be            population to pesticide residues in food or drinking water or from
Minimal                         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              Our review of studies and other documentation related to EPA’s
Assessments Result in Special   completed reregistration reviews of 13 of the 37 pesticides commonly used
Mitigation Measures             on tobacco identified the health risks associated with them and the related
                                mitigation measures the agency required. 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.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



                                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.




                                Page 20                                                 GAO-03-485 Pesticides on Tobacco
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.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.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.27 EPA also identified concerns for some workers who mix, load,


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.



Page 21                                                 GAO-03-485 Pesticides on Tobacco
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.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




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.




Page 22                                               GAO-03-485 Pesticides on Tobacco
applicators.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.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.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



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.




Page 23                                                GAO-03-485 Pesticides on Tobacco
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,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.


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.




Page 24                                                  GAO-03-485 Pesticides on Tobacco
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.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.




33
 The other 6 registration decisions were issued prior to the 1999 guidance.




Page 25                                                GAO-03-485 Pesticides on Tobacco
                                 Table 4: Margins of Exposure for Five Pesticides Approved for Use on Tobacco

                                                                         Margin of exposure           Margin of exposure
                                  Pesticide                                           (male)                     (female)
                                  Actigard                                          518,518                       444,444
                                  Carbaryl                                               104                           89
                                  Dimethomorph                                         1,400                        1,200
                                  Pymetrozine                                          3,333                        2,857
                                  Thiamethoxam                                         3,500                        3,000
                                 Source: GAO and EPA.

                                 Note: GAO’s analysis of EPA risk assessment documents.


EPA Evaluations of Studies Are   EPA requires that pesticide manufacturers provide most of the studies it
Not Always Available             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.


                                 While EPA is required to regulate residues of pesticides approved for use
Federal Regulation of            on human food and animal feed crops, no such requirement applies to
Pesticide Residues on            pesticides approved for use on tobacco. However, primarily as a matter of
                                 trade equity, USDA does (1) regulate residues of selected pesticides that
Tobacco Is Limited               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


                                 Page 26                                                  GAO-03-485 Pesticides on Tobacco
                            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          As discussed previously, EPA regulates pesticides in the United States by
Focuses on Pesticides Not   granting registrations, which permit the distribution, sale, and use of the
Approved for Use on         pesticides according to directions identified on the label. EPA also
                            regulates the residues of pesticides that are approved for use on human
Tobacco                     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,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.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



                            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.




                            Page 27                                                 GAO-03-485 Pesticides on Tobacco
                             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                 USDA has implemented the Dairy and Tobacco Adjustment Act, in part, by
Reevaluated the Pesticides   setting 15 residue limits (maximum allowable concentrations) covering 20
it Regulates Since 1989      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.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.




                             36
                              USDA’s method of measuring residues is consistent with EPA’s and FDA’s.




                             Page 28                                             GAO-03-485 Pesticides on Tobacco
Table 5: USDA’s Residue Limits for Pesticides on Tobacco

                                                        Residue limit      Approved for
 Pesticide                                                 (parts per       nontobacco
 (organochlorine pesticides in bold)                         million)            use(s)
 1. Chlordane                                                     3.0               No
 2. Dibromochloropropane (DBCP)                                   1.0               No
 3. Dicamba                                                       5.0              Yes
 4. Endrin                                                        0.1               No
 5. Ethylene dibromide (EDB)                                      0.1               No
 6. Formothion                                                    0.5               No
 7. Hexachlorobenzene (HCB)                                       0.1               No
 8. Methoxychlor                                                  0.1              Yes
 9. Toxaphene                                                     0.3               No
 10. 2,4-D                                                        5.0              Yes
 11. 2,4,5-T                                                      0.1              Yes
 12. Sum of aldrin and dieldrin                                   0.1               No
 13. Sum of cypermethrin and permethrin                           3.0              Yes
 14. Sum of DDT, TDE, and DDE                                     0.4               No
 15. Sum of heptachlor and heptachlor epoxide                     0.1               No
Source: 7 CFR 29.427, USDA, and EPA.

Note: GAO’s analysis of EPA data.


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.37 For example, by 2000, EPA had cancelled all tobacco uses of
lindane—a highly persistent, organochlorine pesticide that may cause



37
 Not including the cancelled pesticides, about 100 pesticides had approval for tobacco
uses in the 1990s.




Page 29                                                GAO-03-485 Pesticides on Tobacco
                          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   Also as required by the Dairy and Tobacco Adjustment Act, USDA tests
Domestic Tobacco for      certain imported and domestic tobacco to ensure that residues do not
Regulated Pesticides      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 2001.38 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.




                          38
                           USDA Economic Research Service U.S. Tobacco Import Update (TBS-2002-02), Feb. 2003.




                          Page 30                                            GAO-03-485 Pesticides on Tobacco
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)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.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.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.



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.



Page 31                                               GAO-03-485 Pesticides on Tobacco
              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.


              To ensure that pesticides can be used without posing an unreasonable risk
Conclusions   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.


              Page 32                                       GAO-03-485 Pesticides on Tobacco
                     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.


                     To better protect the public from exposures to residues of pesticides not
Recommendation for   approved for use on tobacco in the United States and ensure that domestic
Executive Action     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.


                     We provided copies of our draft report to EPA and USDA for review and
Agency Comments      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.




                     Page 33                                      GAO-03-485 Pesticides on Tobacco
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




Page 34                                        GAO-03-485 Pesticides on Tobacco
              Appendix I: Objectives, Scope, and
Appendix I: Objectives, Scope, and
              Methodology



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


              Page 35                                        GAO-03-485 Pesticides on Tobacco
Appendix I: Objectives, Scope, and
Methodology




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.




Page 36                                       GAO-03-485 Pesticides on Tobacco
                                        Appendix II: Pesticide Use on Tobacco and
Appendix II: Pesticide Use on Tobacco and
                                        Other Crops



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

                           Use in pounds—1992 survey (1990-93)                      Use in pounds—1997 survey (1994-98)
Pesticide                           Tobacco              All crops                           Tobacco                All crops
1,3-dichloropropene
(1,3-D)                           11,537,540               40,083,611                     13,279,285                34,717,237
Chloropicrin                         577,082               11,086,567                      6,761,644                13,882,188
Maleic hydrazide                   1,789,208                2,073,238                      1,790,089                 2,143,154
Acephate                           1,570,457                3,389,865                        871,899                 2,462,354
Methyl bromide                     5,356,748               44,196,554                        685,026                32,803,943
Pendimethalin                        321,931               20,281,766                        473,718                27,284,718
Chlorpyrifos                         685,554               14,764,535                        406,822                13,463,879
Fenamiphos                           257,142                  614,937                        379,841                   726,675
                                           a
Mancozeb                                                    8,062,374                        356,811                 9,585,777
                                           a                         a
Flumetralin                                                                                  352,742                   352,742
Metalaxyl                           371,645                   855,400                        271,368                   659,997
                                           a
Clomazone                                                   1,801,776                        217,617                 2,531,160
Ethoprop                            438,274                 1,449,743                        182,321                 1,010,807
                                           a
Endosulfan                                                  1,796,726                        172,766                 1,601,195
                                           a                         a
Mefenoxam                                                                                    139,199                   210,101
Pebulate                            412,000                   673,046                        131,665                   343,322
Ethephon                            113,238                 2,701,284                        102,130                 5,407,986
Napropamide                         191,840                   500,695                         92,622                   448,400
                                           a                         a
Sulfentrazone                                                                                 69,073                    69,073
                                           a                         a
Imidacloprid                                                                                  67,896                   272,207
Aldicarb                            159,044                 4,022,468                         59,719                 4,277,552
                                           a                         a
Dimethomorph                                                                                  36,818                    51,536
Methomyl                              57,137                2,754,907                         29,773                 1,997,489
Malathion                              7,549                3,377,678                         15,437                 5,809,943
Disulfoton                            52,578                1,806,527                         13,495                 1,196,066
                                           a
Sethoxydim                                                  1,350,566                          9,579                 1,717,271
                                           a                         a
Spinosad                                                                                       2,815                   117,315
Carbaryl                              16,487                4,570,414                          2,057                 4,857,542
Fonofos                               12,798                3,233,797                             16                   417,372
                                                                                                   a
Benefin                               56,963                  478,205                                                  161,983
                                           b                         b                             b                          b
Bacillus thuringiensis
                                                                                                   a
Carbofuran                          149,965                 5,101,406                                                3,398,067
                                                                                                   a
Diazinon                             53,670                 1,265,739                                                  918,087
                                                                                                   a                          a
Diphenamid                           81,624                   105,009




                                        Page 37                                                GAO-03-485 Pesticides on Tobacco
                                                            Appendix II: Pesticide Use on Tobacco and
                                                            Other Crops




                                             Use in pounds—1992 survey (1990-93)                          Use in pounds—1997 survey (1994-98)
 Pesticide                                            Tobacco              All crops                               Tobacco                All crops
                                                                                                                               a                        a
 Isopropalin                                           129,287               129,287
                                                                                                                               a
 Methidathion                                               68               372,953                                                             314,091
                                                                                                                               a                        a
 Trichlorfon                                               722                13,974
 Grand total                                        24,400,552           182,915,047                               26,974,241                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.




                                                            Page 38                                                      GAO-03-485 Pesticides on Tobacco
               Appendix III: Germany, Italy, and Spain Have
Appendix III: Germany, Italy, and Spain Have
               Adopted Regulatory Limits for Pesticide
               Residues on Tobacco


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.1 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.2

               Table 7: Residue Limits Adopted by Germany, Italy, and Spain for Pesticides
               Commonly Used on Tobacco in the United States during the 1990s

                                                         Residue limits in ppm (country)
                                                             a                    b                          c
                   Pesticide                         Germany                 Italy                  Spain
                                                             d                                               d
                   Acephate                                                     1.5
                   Aldicarb                               10.0         0.6 (green)                         5.0
                                                                       3.0 (cured)
                                                             d
                   Benefin                                                    0.01                    0.02
                   Carbaryl                                3.0                  3.0                    0.1
                   Carbofuran                             20.0                  0.1                   10.0
                                                             d
                   Chlorpyrifos                                                 0.2                   0.05
                                                                                   d
                   Diazinon                                1.0                                        0.02
                                                               d                     d
                   Dichloropropene                                                                    0.05
                   Diphenamid                               1.5                   0.1                  5.0
                                                                                                             d
                   Disulfoton                               1.0                   0.4
                                                                                                             d
                   Endosulfan                              20.0                   1.0




               1
                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.
               2
               The seven pesticides are Bacillus thuringiensis, chloropicrin, clomazone, dimethomorph,
               mefanoxam, spinosad, and sulfentrazone.




               Page 39                                                 GAO-03-485 Pesticides on Tobacco
Appendix III: Germany, Italy, and Spain Have
Adopted Regulatory Limits for Pesticide
Residues on Tobacco




                                                      Residue limits in ppm (country)
    Pesticide                                     Germanya                Italyb                  Spainc
    Ethephon                                                       16.0 (green)
                                                          d                                            d
                                                                   80.0 (cured)
    Ethoprop                                            3.0                0.02                     0.02
    Fenamiphos                                         15.0                  0.1                    0.02
    Flumetralin                                                     2.0 (green)
                                                       20.0        10.0 (cured)                      5.0
                                                                                                       d
    Fonophos                                            1.0                0.05
    Imidacloprid                                                   10.0 (green)
                                                          d
                                                                   50.0 (cured)                      5.0
                                                                                                       d
    Isopropalin                                         0.5                0.02
    Malathion                                           3.0                  0.5                     0.5
    Maleic hydrazide                                   80.0               80.0a                     80.0
    Mancozeb                                                        2.0 (green)
                                                                        f
                                                      50.0e        10.0 (cured)                    0.05
                                                                                                       g

                                                          d
    Metalaxyl                                                                1.0                     3.0
                                                                               d                       d
    Methidathion                                        1.0
                                                                               d                       d
    Methomyl                                            2.0
                                                           d                      d
    Methyl bromide                                                                                  20.0
    Napropamide                                          0.1                   0.1                  0.05
                                                                                  d
    Pebulate                                             0.5                                        0.05
                                                           d
    Pendimethalin                                                            0.05                   0.05
                                                           d                                           d
    Sethoxydim                                                                0.5
    Trichlorfon                                          1.0                  0.1                    0.1
    Number of limits for
    commonly used
    pesticides                                           20                     24                   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.


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,


Page 40                                                           GAO-03-485 Pesticides on Tobacco
Appendix III: Germany, Italy, and Spain Have
Adopted Regulatory Limits for Pesticide
Residues on Tobacco




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;3 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.




3
 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.




Page 41                                              GAO-03-485 Pesticides on Tobacco
             Appendix IV: USDA Tests Domestic Tobacco
Appendix IV: USDA Tests Domestic Tobacco
             in the Loan Stock Program



in the Loan Stock Program

             The USDA Farm Service Agency (FSA)1 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.2 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.




             1
              FSA was formed in 1994 from programs in several agencies, including tobacco programs
             from the former Agricultural Stabilization and Conservation Service.
             2
              The price support program is administered by stabilization cooperatives—owned by
             tobacco growers—under agreement with USDA’s Commodity Credit Corporation and
             auction warehouses.




             Page 42                                              GAO-03-485 Pesticides on Tobacco
Appendix IV: USDA Tests Domestic Tobacco
in the Loan Stock Program




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.




Page 43                                      GAO-03-485 Pesticides on Tobacco
                  Appendix V: GAO Contacts and Staff
Appendix V: GAO Contacts and Staff
                  Acknowledgments



Acknowledgments

                  John B. Stephenson, (202) 512-3841
GAO Contacts      Christine Fishkin, (202) 512-6895


                  In addition to those named above, Nancy Crothers, Laura Gatz, Terrance
Acknowledgments   Horner, Richard Johnson, Ilga Semeiks, Tina Smith, and Cheryl Williams
                  made key contributions to this report.




(360204)
                  Page 44                                    GAO-03-485 Pesticides on Tobacco
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