PESTICIDE EXPORT and IMPORT ENFORCEMENT PROGRAMS
in the United States of America
Connie Musgrove1 and Angela F. Hofmann2
1 Chief Executive
Officer, Office of Compliance Monitoring, office of Pesticides and Toxic
Substances, U.S. Environmental Protection Agency, 401 M Street, S.W. (EN-342),
Washington, D.C. 20460 (USA)
2 Environmental
Protection Specialist, Policy and Grants Division, office of Compliance
Monitoring, Office of Pesticides and Toxic Substances, U.S. Environmental
Protection Agency, 401 M Street, S.W. (EN-342), Washington, D.C. 20460 (USA)
SUMMARY
This paper discusses the enforcement programs in the United
States regarding the export and import of pesticide products. This discussion includes an overview of the
legal requirements, their corresponding policies, and enforcement programs, as
well as a discussion of recent trends and proposed changes. The views expressed in this article are
solely those of the authors and do not necessarily reflect the views or
policies of the United States or the
U.S.
Environmental Protection Agency.
1. THE U.S.
ROLE IN THE INTERNATIONAL TRADE OF PESTICIDES
The United States Environmental Protection Agency (EPA)
estimates that approximately 4.2 to 4.5 billion pounds of conventional
pesticides (measured as active ingredients) are produced and used in the world
each year, approximately 3.4 billion pounds for agricultural purposes and
approximately 1.1 billion pounds for non-agricultural purposes.(l) In 1988, the
United States exported approximately 450 million pounds of pesticide active
ingredients for agricultural purposes (i.e., not including wood preservatives
and disinfectants), valued by the United States Department of Commerce at
almost 1.7 billion US dollars, and representing approximately 10 percent of
total world consumption.(2) The United States, along with other countries which
also export a large amount of pesticide active ingredients (e.g., the Federal
Republic of Germany, Japan, France, and the United Kingdom), acknowledges the
responsibility it has to provide information about the risks of such
pesticides.
There has been increasing awareness and concern regarding
the use of pesticides and their effect on human health and the
environment. As a result, the world has
turned its attention to the international trade of pesticides and the roles and
responsibilities of exporting and importing countries, as well as the industry
and public sector groups, to communicate information about the potential risks
involved with pesticide use. In
addition, since the United States imports approximately 15 percent of the
agricultural products it consumes, attention has also increased significantly
within the United States, resulting in increased pressure on EPA to ensure
compliance with the pesticide export and import laws, as well as on the United
States Food and Drug Administration (FDA), the United States Food Safety and
Inspection Service (FSIS), and EPA to ensure compliance with the food safety
laws of the United States.
2. PESTICIDE
EXPORT POLICIES AND ENFORCEMENT PROGRAM
As a major exporter of pesticides, as well as a major
importer of foods which may be treated by pesticides, the United States
believes that it has a responsibility to help reduce potential adverse affects
from pesticides, to actively monitor pesticide use, and to promote food safety
world-wide. In the United States,
pesticides are subject to the requirements of the Federal Insecticide,
Fungicide and Rodenticide Act (FIFRA) and the regulations issued under its
authority.(3) FIFRA section 17, 7 U.S.C. § 136ol gives EPA the authority to
regulate American exportation and importation of pesticides, devices, or active
ingredients used in producing a pesticide.
FIFRA section 17 also delineates EPA's international responsibilities
regarding the exchange of information and assistance to other countries in
developing pesticide regulations.
In addition to FIFRA, other laws in the United States may
effect pesticide use by regulating residue levels on food products imported
into the United States. For instance,
the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. § 301 et seq.,
requires EPA to establish maximum permissible residue levels (tolerances) for
pesticides in or on food and feed crops.
Imported and domestic food and feed products are monitored by the United
States for residue levels which exceed established tolerances.
2.1. Summary
of Export Requirements and Policies
All pesticide exporters, pursuant to FIFRA section 17(a),
must comply with certain minimal requirements regarding product labeling,
establishment registration, and recordkeeping.
In addition, an exporter of an unregistered pesticide is required to
obtain a signed statement from the foreign purchaser acknowledging that the
pesticide is not registered and cannot be sold for use in the United
States. The acknowledgement statement
must be obtained prior to export and submitted to EPA within seven days of
receipt by the exports, or by the date of export, whichever occurs first. EPA then transmits a copy of the
acknowledgement statement to an appropriate government official in the
importing country.
A 1980 policy statement for FIFRA section 17(a) informed the
public of the scope of the labeling provisions, including a bilingual
requirement for certain information, and the procedures that an exporter of an
unregistered pesticide must follow in obtaining the purchaser acknowledgement
statement.(4) The policy also specified what information would minimally be
expected to be included on the statements; clarified that the statements need
only be submitted prior to the first shipment each year to a specific purchaser
in a particular country; and stated that a product would not be considered
unregistered for the purposes of the acknowledgement requirement, if the
exported pesticide is substantially similar in composition and use to a
pesticide registered by EPA.
The purpose for requiring exported pesticides to be
minimally labeled under FIFRA, is to provide important and useful information
to anyone who handles or comes in contact with the product and to provide basic
information to end users. In addition,
the purpose of the purchaser acknowledgement statement requirement is both to
inform the purchaser of the product's registration status in the United States
and to notify the government of the importing country that a pesticide judged
hazardous to human health or the environment, or for which no such hazard
assessment has been made, will be exported to that country.
Whenever a pesticide registration, or a cancellation or
suspension becomes effective, or ceases to be effective, FIFRA section 17(b)
requires EPA to provide notification to other governments. In a 1975 policy statement, EPA interpreted
this requirement as applying to "information having international
significance," and published criteria for the interpretation.(5) Whenever
a significant regulatory action is taken, EPA transmits a section 17(b) notice
of control action, explaining the health or environmental concerns that
prompted the action, through the United States Department of State (State
Department) to the appropriate officials in other governments.
The monitoring of exports in the United States is achieved
through the inspection of the exporter's books and records. Pesticide exporters may be identified
through the monitoring of production reports under FIFRA section 7, 7 U.S.C. §
136e, while others may be identified through the Port Import/Export Reporting
Service (PIERS) database of the Journal of Commerce. Once identified, EPA then randomly selects a statistically significant
number of chemicals or Production establishments for target compliance
monitoring.
2.2. The 1989
Comprehensive Review
As a result of increased concern regarding the potential
adverse effects of the international use of pesticides, and in light of EPA's
goal to have a more effective enforcement program for pesticide exports which
is in harmony with international efforts, EPA conducted a comprehensive review
of its pesticide export program.
Included in this review was an evaluation of EPA's current export
enforcement program; the policy on the FIFRA section 17(a) labeling provisions
and requirement to obtain a purchaser acknowledgement statement; the policy on
FIFRA section 17(b) regarding notification to other governments whenever a
pesticide registration, cancellation, or suspension becomes effective, or
ceases to be effective; the confidential nature of information collected on
pesticide exports; and EPA's international efforts regarding pesticide
activities and technical assistance.
A primary achievement of the comprehensive review was the
publication on February 12, 1990, of two proposed policy statements regarding
EPA's pesticide export policy. The
public comment period for both policies ends on May 14, 1990. A proposed policy statement entitled
"Pesticide Export Policy Review" presents the results of the
comprehensive review, a description of the proposed options for expanding the
FIFRA section 17(b) notification system, a new evaluation of the confidential
nature of information collected by the export programs, and a discussion of
other international pesticide activities and their relationship to EPA's goals
in this area.(6) Another proposed policy entitled "Statement of Policy on
the Labeling Requirements for Pesticides, Devices, and Pesticide Active
Ingredients Intended for Export and Procedures for Exporting Unregistered
Pesticides" presents the proposed amendments to the FIFRA section 17(a)
policy.(7)
The major changes proposed to the FIFRA section 17(a) policy
included: a) the elimination of or amendment to the exemption from the
purchaser acknowledgement statement requirement for unregistered pesticides
considered to be "similar in composition and use" to EPA registered
pesticides, or requiring substantiation of such claims; b) requiring
acknowledgement statements to be multilingual; and c) allowing products shipped
purely for research and development purposes to be exempt from the purchaser
acknowledgement statement requirement, but requiring records and/or reports to
substantiate such claims. The proposed
policy also solicits comments on whether the timing of the submission of the
purchaser acknowledgement statements should be changed, whether the current
bilingual labeling statements should be required to be multilingual, and proposes
that the purchaser acknowledgement statements be transmitted directly to
appropriate importing government officials, rather than through diplomatic
channels. The proposed policy also
clarifies that the labeling provisions apply to all exported pesticides,
including those unregistered pesticides that may be exempt from the purchaser
acknowledgement statement requirement.
In addition, EPA has reviewed the effectiveness of the
existing notification scheme for FIFRA section 17(b) and is proposing to improve
the notification system by greatly expanding the number of pesticide regulatory
actions requiring the transmission of an international notice. The control actions which will trigger a
section 17(b) notice, go beyond those adopted by FAO and UNEP under the PIC
system which is described below. Rather
than issuing notices on a case-by-case basis, EPA would notify other
governments of all actions taken on the basis of health and environmental
concerns. As a result', notices would
be issued immediately after an action was taken for all final and proposed
Cancellation and suspension actions taken for health or environmental reasons,
and for all denials of a tolerance following a formal finding that risks
outweigh benefits. Notices for other
regulatory actions would be compiled into a single notice to be transmitted
annually. To reduce delays, EPA is
proposing to transmit notices directly to other countries rather than sending
them through the State Department.
Copies would be forwarded to the State Department, as well as to the
Food and Agricultural organization of the United Nations (FAO). In addition, EPA is proposing to clarify the
confidential nature of certain information submitted as a result of the export
programs.
EPA believes that these proposed changes are necessary to
improve the ability of EPA to enforce the export requirements of FIFRA, as well
as to provide other governments with necessary information about
pesticides. The information provided is
intended to help other governments develop or administer their own
scientifically-based, comprehensive pesticide regulatory programs. These programs are needed to help ensure
that pesticides are used safely and that pesticide use does not result in
harmful residue levels in food or the environment.
2.3. Inspection/Enforcement
Program.
As a part of the comprehensive review, EPA also undertook an
inspection program during the summer of 1989 to evaluate compliance with the
FIFRA section 17(a) requirements.
Because unregistered pesticides are intended solely for export and are
subject to the purchaser acknowledgement statement requirement of section
17(a)(2), EPA compiled a list of unregistered pesticide products utilizing the
1987 production reporting forms, which are required to be submitted to EPA under
FIFRA section 71, in order to identify potential violators and targets for the
inspections. The list resulted in the
identification of 312 unregistered pesticide products and the establishments
responsible for their production. From
this group, a total of twenty-six producing establishments were then randomly
selected and targeted for inspection using a neutral administrative inspection
scheme. The establishments inspected
produced 215, or 69% of the 312 products from the list.
Based on a preliminary review of the inspections conducted,
it appears that several exporters are not in full compliance with the
requirements of FIFRA section 17(a). In
fact,, during the first quarter of 1990, EPA filed administrative complaints
against eight companies, charging them with unlawfully exporting pesticides and
seeking penalties totaling 2,835,200 US dollars.(8) The charges against the
companies include: the export of pesticides labeled only in English to
countries in which English is not the official language; failure to obtain the
purchaser acknowledgement statement for pesticides not registered in the
'United States; and failure to label unregistered pesticides with the
statement, "Not Registered for Use in the United States of
America."(9)
This initiative, aimed specifically at unregistered exported
pesticide products, was EPA's first experience with conducting an export
specific enforcement program. In the
past, compliance with the export requirements was just one of the many
components of routine, chemical specific, and/or for cause inspections. In order to continue with an active export
compliance monitoring program, EPA counterparts at the State level, which
conduct the majority of EPA's FIFRA compliance inspections under the State
Cooperative Enforcement Agreement Guidance, will be requested to continue to
actively monitor compliance with the export policy. We are still in the process of evaluating our experiences and the
information obtained from the inspections, in order to identify improvements to
our export enforcement program.(10)
2.4. International
Obligations
EPA's principal goal in international pesticide activities
is to improve the protection of public health and the environment from
unreasonable adverse effects of pesticides throughout the world. EPA is committed to its responsibilities
under FIFRA section 17(d) of assisting other countries in the assessments of
specific pesticides under the conditions of use in their country, and in the
development of the capabilities to make such decisions on their own. In furtherance of this goal, and in
cooperation with international organizations such as FAO and the United Nations
Environment Programme (UNEP), EPA is actively engaged in training programs for
developing countries and other organizations to assist them in building or
strengthening their pesticide regulatory infrastructures. The Agency has also participated in the
development of an environmentally sensitive control strategy for the locust
plague in Africa and will soon be training Peace Corp volunteers and their host-country
counterparts to teach farmers and dealers in developing countries how to handle
and use pesticides safely.
UNEP and FAO adopted programs in 1989 of prior informed
consent (PIC) for the international trade of chemicals which have been banned
or severely restricted.(11) Under the PIC system, participating countries will
be obligated to: a) inform an international organization whenever a pesticide
is severely restricted or banned in their country; b) advise the organization
of their decisions on the importation of a pesticide being added to PIC; c)
take measures to inform the export industry of the decisions of other
countries; and d) take actions within their legal authority to help ensure that
their exporting industry complies with the decisions of importing countries.
In this regard, the United States supports the efforts of
FAO and UNEP, and EPA will be reviewing its statutory authorities regarding
exports to determine the extent to which it can develop and implement an
effective enforcement program. EPA
welcomes ideas from the regulated industry and other governments on techniques
and experiences they may have with policing similar export programs.(12)
Prior to adoption of the PIC procedure, both FAO and UNEP
provided for information exchange on regulatory actions taken to ban or
severely restrict a pesticide for health or environmental reasons and on the
export of these pesticides, which are continued in the revised guidance
incorporating PIC. The program in the United
States, under FIFRA section 17, complies with the information exchange
provisions of the two international organizations and goes further by including
unregistered pesticides, more frequent export notifications, send by expanding
control actions which trigger the notification. As the United States develops programs for compliance with PIC,
EPA will continue to meet the information exchange provisions of the
international organizations, as well as those self imposed.
3. PESTICIDE
IMPORT POLICY AND ENFORCEMENT PROGRAM
The United States believes that a strong import enforcement
program is one of the best defenses against the Importation of unwanted
pesticides. In order to be able to
regulate the importation of pesticides, it is essential to know when they
initially arrive, enabling officials with sufficient legal authority to take
any immediate action that may be necessary in order to prevent adverse
exposure. Pursuant to FIFRA section
17(c), and the corresponding regulations promulgated by the United States
Customs, 19 C.F.R. §§ 12.112 - 12.117, an importer of pesticides or devices
into the United States is required to submit a Notice of Arrival, EPA Form
3540-1, prior to the arrival of the shipment in the United States. EPA reviews the Notice of Arrival '
providing specific directions to the U.S. Customs officials, and returns the
form to the importer so that it can be presented by the importer to United
States Customs at the port of entry.
By providing EPA with advance information about the import
of the pesticide, the Notice of Arrival is an important enforcement tool. The Agency may direct U.S. Customs Officials
to release the shipment, detain it for inspection by EPA officials, release it
under bond for inspection, request a sample, provide specific directions, or
refuse entry entirely.
All pesticide products imported into the United States, and
the establishments in which they are produced, must meet the same requirements
under FIFRA as domestic producers.(13) As such, the imported pesticide product
must be registered with EPA and must meet all the labeling requirements of
FIFRA. The producer must also register
those establishments in which the imported product is produced and submit
annual production reports on the types and amounts of the pesticide product
shipped to the United States. In
addition, for materials shipped to the United States, a producer must maintain
certain records, i.e., of production and shipments to the United States,
inventories, and tests conducted.
Records must be maintained for two years, or as specified, and are
subject to inspection and reproduction by authorized EPA representatives.
Failure to present a Notice of Arrival will result in the
prohibition of the import. In addition,
imported pesticides which do not meet the requirements of FIFRA will be refused
entry into the United States. If the
shipper does not retrieve the merchandise within the specified period, the
shipment may be destroyed or disposed of by U.S. Customs officials.
As mentioned earlier,, the United States also monitors
imported food and feed crops for illegal pesticide residues.(14) To enforce the
tolerances established by EPA, the FDA monitors residue levels in all food and
feed crops and the United States Department of Agriculture (USDA) monitors
residue levels in poultry and meat products.
Imported shipments which contain illegal pesticide residues may be
detained at the port of entry and an automatic detention for future shipments
from the same source may be invoked.
4. INTERNATIONAL
COOPERATION AND COORDINATION OF ENFORCEMENT
The quality and safety of the American food supply is a high
priority for the United States Government, and the United States intends to
place a greater emphasis on the monitoring of pesticide exports and food
imports. In addition, EPA is actively
participating in the development of practical environmental protection programs
world-wide to promote the safe handling and use of pesticides and in order to
help reduce adverse affects to public health and the environment.
The international trade in pesticides has created both
opportunities and responsibilities for all countries involved in the trade of
pesticides, as well as in the trade of pesticide treated products. The resulting risks and consequences of
pesticide misuse can be catastrophic to all concerned. Fear of competitive disadvantages, varying
export regulations, regulatory abilities, and philosophies regarding pesticide
regulations fragment efforts to minimize potential adverse effects. It is necessary to approach this issue on an
international level, harmonizing individual country actions with those of the
international community, developing a uniform policy regarding pesticides, and
an international enforcement program.
This can best be achieved by cooperation among all the
countries, by sharing information on regulatory actions, and by enhancing
international enforcement. As George
Bush, the President of the United States said, "If our response [to global
environmental problems is to be effective, then all the nations of the world
must make common cause in defense of our environment."(15) The
international community is being pulled together by the increasing awareness of
the potentially global adverse effects of pesticide use and the importance of a
world-wide effort to minimize these adverse effects.
REFERENCES
1. U.S. EPA,
Pesticide Export Policy Review: Proposed Policy Statement, 55 Fed. Reg. 4956, 4956 (February 12, 1990).
2. id.
3. 7 U.S.C. §§
136 et sea., codified at 40 C.F.R. §§ 152 et seq.
4.
45
Fed. Reg. 50274 (1980).
5.
40
Fed. Reg. 20987 (1975).
6. 55 Fed. Reg. 4956 (1990).
7. 55
Fed. Reg. 4967 (1990).
8. Equivalent
to 5,330,176 G (Netherlands), 4,743,289.60 DM (Federal Republic of Germany),
16,071,331 Fr (France),, or equivalent to 2,320,044.10 ECUs (European Currency
Unit). (Rates are based on the New York Foreign Exchange rates on Thursday,
February 22, 1990.).
9. Since these
cases are still pending, the final resolutions were unavailable at the time of
printing. The speaker, however, will
mention any final resolutions at the Workshop.
10. Although at
the time of printing this information was unavailable, the speaker will include
some of our experiences in the oral presentation.
11. FAO,
International Code of Conduct on the Distribution and Use of Pesticides, Rome,
1989; UNEP, London Guidelines on the Exchange of Information on Chemicals in
International Trade, 1989.
12. Any comments
or suggestions may be addressed to Edwin L. Johnson, Director, International
Issues Division, Office of International Activities (A-106),
Telefax: (202)382-4470 or to Cathleen Barnes, Office of
Pesticide Programs (H7501C), Telefax: (202)557-8244, U.S.
Environmental Protection Agency, 401 M Street, S.W.,
Washington, D.C. 20460, USA.
13. See
FIFRA, 7 U.S.C. §§ 136 et seq., and its accompanying regulations at 40
C.F.R. §§ 152 et seq.
14. See the
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. § 301 et seq.
15. President
George Bush, What I believe about the Environment, 16 EPA Journal
3 (1990).