PROTECTION FROM INEFFECTIVE PESTICIDES
Prepared by the Program Evaluation Division
Office of Planning and Evaluation
Office of Planning and Management
September 8, 1975
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TABLE OF CONTENTS
EXECUTIVE SUMMARY
I. INTRODUCTION 1
II. SCOPE OF THE PROBLEM 3
How Ineffective Products Could
Reach the Marketplace 4
The Potential Hazards of Using
Ineffective Pesticide Products 1
The Ability of the Market to Limit Damage 9
III. EPA'S REGULATION OF PESTICIDES 14
Registration *4
Surveillance at the Producing Establishment 18
Market Surveillance 23
Postregistration Efficacy Testing 25
IV. OPTIONS 32
Preregistration Efficacy Testing 32
Data Review 33
Producer Establishment Surveillance 35
Market Surveillance 36
Postregistration Efficacy Testing 38
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EXECUTIVE SUMMARY
A study team from the Program Evaluation Division of the Office of
Planning and Evaluation has conducted a detailed reviewof EPA’s role in
providing protection from ineffective pesticides. The review examined
the policies, procedures and performance of the Agency in keeping
ineffective products from being formulated, marketed or used.
Because of their toxic characteristics, most pesticides pose some
threat to man or to the environment. The goal of EPA regulation of
pesticides is to ensure that the benefits provided by use outweigh the
negative effects. For this reason the Agency is concerned with efficacy,
the degree to which a pesticide product is capable of providing beneficial
results.
Five major activities comprise the existing efficacy assurance
program:
• Preregistration testing , the biological evaluation of the pesticidal
properties of a product submitted for registration.
• Data review , an analysis of the materials submitted in support
of a product registration.
• Producer surveillance , the inspection of the producing establish-
ment,-during which product samples may be taken.
• Market surveillance , the inspection of retail establishments,
during which product samples may be taken.
• Postregistration testing , the biological evaluation of the
pesticidal propertfes of a registered product.
This report includes a series of recommendations designed to refine
the regulatory process. The major thrust of the recommendations is that
a lower level of testing would provide adequate protection for most product
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groups, but that disinfectants and rodentic ides should be reviewed more
carefully prior to registration and sampled more frequently thereafter.
Developthent of standard test methods should be emphasized.
A summary of the report’s major findings and recommendations follows:
How Ineffective Products Could Reach the Marketplace
• Five of the hypothetical channels to the marketplace account
for very few of the ineffective products discovered. These
include nonregistration. registration in error, registration
under less rigorous requirements, shelf deterioration and
developed resistance.
• Minor product changes and poor production procedures
account for the largest share of enforcement actions taken
against ineffective products.
The Potential Hazards of Using Ineffective Pesticide Products
• The health and environmental effects caused directly by
ineffective products are extremely small.
• Severe health problems could result from reliance.on
ineffective products where the user cannot readily
determine the degree of control. The most significant
examples of such pesticide groups are rodenticides and
disinfectants.
The Ability of the Market to Limit Damage
• Producers of large volumes of pesticides have an incentive
to market effective products in order to maintain their sales
volumes and avoid any liability for damage.
• Agricutural products, which account for nearly sixty per cent
of national pesticide use, are almost always effective as a result
of the careful evaluation they receive by both producers and users.
• Consumer garden products are generally reformulations of
agricultural products which are well tested.
• Industrial users are capable of protecting themselves with
performance contracts and product testing.
• For the majority of pesticides, the user can determine that a
product is ineffective in time toswitch to an effective substitute.
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E PA ’s Regulation of Pesticides
• No formal study has been conducted by the management of
the pesticide program to determine which pesticides or pesticide
uses are most likely.to be violative. Consequently, there is no
assurance that the limited resources available for registration
data review, sampling, efficacy evaluation or enforcement have
been concentrated on the major problem areas.
• No formal guidelines have been drafted to indicate when an
efficacy consideration should initiate a cost/benefit review,
the first step in the registration cancellation process.
• OPP has not developed a policy for selecting the specific
products to be tested. Consequently, there is no assurance
that FED will sample the products likely to be defective.
• No formal follow-up system has been established to assure
that the results of effica ’y tests conducted by the biological
evaluation laboratories are used or even considered by the
Registration Division or the Pesticides Enforcement
Division.
• A review of the products identified as being defective in
three or more samples indicates that even when products
are clearly suspect, EPA action frequently has not been
sufficient to prevent their continued use.
Program Management Recommendatior s
• All preregistration biological evaluation activity should be
curtailed.
• Efforts to develop standard testing methods should be
increased.
• Data review prior to registration should be maintained for all
products. Applicants seeking to register products which have
suspect active ingredients or which could present serious
health problems. if ineffective should be required to present
corroborative data from an independent testing laboratory.
• The sampling program should include greater emphasis on
products with histories of violations.
• The laboratories should communicate to the Regional Offices
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the specific products to be sampled. The sampling program
should provide the biological evaluation laboratories with
samples of requested products.
• Follow-up testing on the product should be conducted
immediately if a sample is found to be defective.
• Producers should be notified of all defects suspected in
their products.
• Enforcement and registration actions should be taken against
all producers marketing products which the laboratories
demonstrate to be violative.
• All routine postregistration biological evaluation activity
should be curtailed. Only testing for specific registration
or enforcement purposes should be continued.
• Program management should conduct a formal study to
determine which pesticides or pesticide uses are most
likely to be violative. Resources should then be concentrated
in these areas.
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PROTECTION FROM INEFFECTIVE PESTICIDES
I. INTRODUCTION
In March 1975 the Program Evaluation Division began the second phas,e
of a comprehensive evaluation of EPA’s pesticide programs. One element
of the evaluation is the preparation of short, operationally relevant papers
on issues suggested by the program office. This report is based on a
request to examine the Agency’s policy for assuring the efficacy of marketed
pesticide products.
Because of their toxic characteristics, most pesticides pose some threat
to man and to the environment. This inherent risk is normally justified by
the benefits that proper use can provide. OccasIonally, however, a pesticide
does not achieve its intended results. In many cases timing or technique
of application is to blame, and the applicator is. responsible for the ensuing
damage. In other cases the product itself is inherently incapable of
effective action.
The goal of EPA regulation of pesticides is to ensure that the benefits
of use outweigh the neg 1tive effects. Evidence of efficacy, the degree to
which a pesticide product is capable of providing beneficial results, is thus
inseparable from an evaluation of the usefulness of the product. The Agency
requires this information to ensure that the inherent risk is not “unreasonable”
as defined in the Federal Insecticide, Fungicide and Rodenticide Act as
amended (FIFRA).
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In order to assess whether EPA regulatiohs permit ineffective
pcstic (1es to advcr ;e1y affect man or the environment, this paper will
answer the following questions:
• I-low do ineffective products reach the marketplace?
• What are the potential hazards associated with the use of
ineffective pesticides?
• Is the normal market mechanism able to limit the damage
caused by ineffective products?
• What does EPA do to assure protection from ineffective products?
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II. SCOPE OF ‘F i lE PROBLEM
Unfortunately, it is exiremely difficult to be completely successful
in keeping ineffective pesticides from being produêed, marketed or used.
In spite of EPA’s regulatory system, several products with potential efficacy
problems are identified each year. In the past eighteen months EPA has
issued Notices of Intent to Cancel t ’ the registrations of over twenty-five
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pesticide products for reasons of ineificacy
While there is no doubt that some ineffective products exist, the
magnitude of the problems they cause is ill-defined. One of the major
reasons contributing to lack of problem definition is that efficacy itself
is difficult to determine. The acceptable degree of effectiveness exhibited
by a particular product is relative to the control provided by the substitutes.
In some cases a product which is able to kill 70 per cent of the target
pests is considered effective, since no alternative product offers signifi-
cantly better control. In other cases 70 percent control is unacceptably low,
so the product is considered ineffective even though it kills many pests.
The n ed for regulation to eliminate ineffective products depends on
the potential problems they cçuld cause. These problems must be defined
so that decision-makers can determine where resources are best expended.
This section describes the scope of the problem, beginning with a general
discussion of the various ways that an ineffective product could reach the
marketplace and the consumer. A discussion of economic, human health
and environmental effects follows. The section concludes with a discussion
of the ability of the market to limit the damage which continued use could
cause.
1/ For example, the Federal Register, Vol. 39, No. 8 (1/11/74), Page 1665,
Tists the Notices of Intent to cancel 17 different product registrations for
efficacy resons.
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ITOW U” 1 FFECTIV 1! PRODUCTS REACh THE MARKETPLACE
Commercial distribution of a pesticide product is not a guarantee
of effectiveness, since there are at least seven different ways that an
ineffective product may reach the market: as a nonregistered product
as a product registered in error; as a product registered under less
rigorous requirements; as a product whose useful life has expired; as a
product to which the target pest has developed resistance; as a poorly produced
product; or as a product affected by minor changes. This section assesses
each of these routes in order to determine the magnitude of the problem and
the best control methods.
A. Nonregistered products . Some pestièides are marketed in the United
States without first being registered with EPA. These products may be ineffec-
tive for a number of reasons, including an inherently ineffective active ingredient,
an insufficient amount of active ingredient, incompatible inert ingredients,
instability of formulation, dosage rates in labeling directions too low, other
inadequate directions for use, etc. Since no objective review of test data has
been conducted, there is no assurance that the product is capable of achieving
its intended result.
Two factors combine to make nonregistered products a declining problem.
First, products previously registered by states for intrastate use only must be
federally registered by October 21, 1976. This change was authorized by the
Federal Environmental Pesticide Control Act (FEPCA) of 1972, which amended
the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). It
extends federal data requirei ents to an estimated 15, 000 products. Second, in
the past most nonregistered products were not submitted to EPA because the
producer was unaware of the registration requirement. This is especially true
of products such as dog repellants, which are defined as pesticides under the
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Act but which may not normally be considered in that category. In an effort
to encourage compliance, EPA emphasized increased surveillance and made
prosecution of violative companies marketing nonregistered products a high
priority. From 1971 to 1973 over 78 percent (135 to 173) of enforcement
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actions were based on nonregistration. This effort was apparently successful,
since, in response to the reduced number of violations discovered, the
emphasis of EPA enforcement efforts has been shifted.
B. Registration in error . To register a product with EPA an applicant
must show that a pesticide is safe and effective when used as directed. EPA
conducts very few preregistration tests. Instead, reviewers in the Registration
Division of the Office of Pesticide Programs evaluate the data submitted in
support of the application. Approval is given if all the required information
is present and if the test results submitted indicate that the product will control
the pest. Because of this reliance on summary data provided by the applicant,
the possibility exists that an ineffective product could be approved for registration.
The recently promulgated regulations for registration should further reduce
this already limited possibility.
C. Registration under less rigorous requirements . Efficacy data has
been a required part of the registration application only in recent years, partly
in response to the increasing awareness of environmental problems. Products
initially re istered prior to the 1972 amendments were subject to a less compre-
hensive eff ctiveness review. Although some ineffective products may have been
registered and are still being sold, this problem can be eliminated during the
effort to reregister all pesticides by October 1976, if the new, more rigorous
requirements are applied during this period of heavy workload.
2T U. S. Environmental Protection Agency, The First Two Years ,
February 1973, pages 260-280.
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1), Deterioration on the shelf . Some registered products contain one or
more ingredients whieh may lose their effectiveness over time. If sufficient
deterioration occurs between production and use, the pesticide might be
ineffective even when used according to the label directions.
The label dating requirements of the Section 3 regulations should eliminate
this problem.
E. Developed resistance . Because of varying susi cptibility to toxins,
many pest species, especially insect pests, are capable of developing a
resistance to the active ingredients in pesticides. Those organisms genetically
endowed with the ability to resist the chemical survi’cfe to reproduce the entire
population, which will be similarly resistant. The consequences of developed
resistance are limited by the fact that agricultural associations and pesticide
producers often discover and publish information on resistance in time for
users to apply alternatives. When EPA is notified that pests have developed
resistance to a particular pesticide, registration action is taken to delete that
pest from the labeling claims and directions of products containing that active
ingredient.
A similar problem impacts the effectiveness of rodenticides. In the case
of commensal rat and mouse baits, the pests often learn” to avoid the
pesticide. Thus, even though the active ingredient is inherently effective,
the pesticide as formulated may not be..
F. Poor production process . During formulation or manufacture of a
product, quality control problems can alter the proportion of ingredients or
the physical composition with equally deleterious results on its efficacy. An
unpublished study of EPA’s enforcement activities indicates that such deficien-
cies account for the largest proportion of the inefficacious products on the
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market. The EPA review at the time of registration attempts to insure con-
sisteiicy of marketed products by examining the manufacturing process and
quality control procedures.
CL Minor product changes . Producers occasionally make “minor ’ 1
changes in product formulation or manufacturing procedures which limit the
product’s effectiveness. For instance, packaging changes which allow
crushing or decomposition, formulating changes which alter particle size,
changes in the source of supply of intermediate products which reduce the
purity of the finished product, minor changes in the inert ingredient, or
implementation of economies in production stages, such as a reduced clean up
procedures, may result in reduced effectiveness or increased hazard to man,
non-target animals or beneficial plants. Typically, producers correct these
problems when they find out about them, so the magnitude of environmental
contamination is limited.
THE POTENTIAL HAZARDS OF USING INEFFECTIVE PRODUCTS
Aggregate statistics on the problems caused by pesticides have tended
tà be unreliabl ’ , primarily because of the difficulties associated with
measurement technique and attribution of damage. That portion of such
impacts due specifically to ineffective products is even more difficult to
quantify in any meaningful way. This section therefore describes in
general terms the problems which could develop, without attempting to
provide quantification of the extent to which they actually occur.
A. Economic considerations . Concern over the economic and
consumer protection aspects of pesticide use has had a relatively long
history. The Insecticides Act of 1910 was a consumer protection measure
designed to assure that a purchased chemical insecticide would effectively
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mitigate pest problems. Three of the major issues which motivated passage
of the Act are still ( orIcerns:
1. Consumer protection. The average consumer is not always able to
determine if a pesticide product has adequately controlled the target pest.
Furthermore, the purchaser usually assumes that the product, particularly
if it displays an EPA registration number, will be effective. Regulation of
the industry is necessary to ensure that the consumer is not being defrauded
by mislabeled, ineffective, or adulterated products.
2. Crop losses. Some agricultural users might suffer crop losses
because of unexpected variations in the strength of purchased chemicals.
A user may apply an ineffective pesticide and discover only after it is too
late to salvage the crop that the product does not control the target pest.
For this reason the use of ineffective pesticides could have severe economic
effect on the individual farmer, whileat the same time reducing the nation s
available food and fiber.
3. Natural control loss. Since pesticides are toxic chemicals, the use
of a pesticide which does not have the desired impact on a target pest could
upset the ecosystem in the application area. One possible result would be
the elimination of natural predators or other biological controls, so that
after application the pest was more of a menace than before.
B. Human health considerations . Use of an ineffective pesticide
adversely affects human health in two ways:
1. Loss of protection from target pest. The loss of protection could
be most serious in cases of ineffective sanitizers, sterilizers or germicides,
where the consumer may be unable to determine the effectiveness of control.
Continued reliance on such products may result in outbreaks of infection or
disease. Similarly, ineffective rodenticides or insecticides could increase
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the danger of e>posure to diseases transmitted by rodents, ticks or insects.
2. Applicator exposures. While the use of any pesticide exposes
applicators to some risks of contact or inhalation, the use of an ineffective
pest.ic ide involves risks without sufficient countervailing pest control benefits.
rf j5 is especially true with some of the more highly toxic pesticides. More-
over, because one application of an ineffective product does not provide
control, repeated appli cations with the same product or an alternative are
needed. Each additional application increases the exposure of the applicator
to the inherent toxicity of the product.
C. Environmental considerations . As indicated above, the use of an
ineffective pesticide upsets the ecosystem in the application area without
pr vi ding expected benefits. Individual non -target organisms susceptible to
the active ingredient will be affected to some degree. Extensive use of such
chemicals could cause damage to entire populations or species.
THE ABILITY OF THE MARKET TO LIMIT DAMAGE
The preceding discussion indicates that channels do exist through which
ineffective products could reach the marketplace. Even so, government
regulation would not be necessary if natural market forces are capable of
controlling any problems. This section examines some of the influences
which limit production and distribution of ineffective products.
•The relative ability of the market to influence producers is enhanced
by three factors. First, although th re are exceptions, the management
and research personnel of nearly all pesticide manufacturers developing data
to support registration are responsible individuals with personal reputations to
uphold. Second, many of the large pesticide producers are divisions of huge
multinational firms and represent comparatively small portions of the
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gross as ;cIs of the i arent firmr. Consequently these producers do not wish
lo generate adverse publicity which might damage the entire firm. Third,
the financial consequences 0 marketing ineffective products are also hnpor-
tant. Recalls, adverse publicity, future buyer resistance and other associated
penalties could be very costly to a producer.
Because of basic differences in various sectors of the pesticide market,
the remainder of this discussion has been divided into three sections cor-
resjionding to the major categories of pesticide uses: agricultural, industrial
and governmental, and home and garden.
A. Agricultural, uses . Agriculture is the largest consumer of pesticides,
3/
accounting for nearly 60% of national pesticide use in l97l Historically,
few problems have developed in this user area, apparently because of three
factors which act in combination to assure an overwhelming proportion of effective
products. First, the competitive nature of agriculture forces farmers to be
good businessmen. They cannot afford to spend large sums annually on products
which will not perform, and they must therefore learn about new developments
in the agricultural chemicals market. Farmers obtain information about
pesticides from a number of sources in addition to manufacturers and suppliers.
During the winter, farm organizations such as the American Farm Bureau
Federation, the Grange and various farm cooperatives hold public sessions at
which many aspects of farming and pesticide use are discussed. They also
publish newsletters and educational pamphlets. Similarly, the Agricultural
Extension Service through its local or county agents provides information
to farmers about product efficacy, application timing and alternative pest
controls. Agricultural schools and land grant colleges assist in providing
3/ USDA Economic Research Service, Farmerts Use of Pesticides in 1971 ,
uly 1974, p. 5.
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the services described above as well as opurating programs of their own.
Approval or recommendation by these or similar groups is often an informal
precondition for large sales volume in agriculinral communities. Producers
often sponsor numerous field tests throughout the country to demonstrate
the value of their products and convince such groups to offer endorsements.
This field testing further assures effectiveness.
Second, the effectiveness of an agricultural product is often readily
apparent to the trained eye of the farmer. Without evidence of appropriate
levels of pest control, farmers are quick to switch to other products to protect•
their crops.
Finally, because pesticides are economically important to the farmer,
legal action against ineffective products can occur as the farmer seeks to recoup
his purchase price plus the value of lost production. There are relatively few
documented litigation s dealing with ineffective agricultural pesticides, since
many producers will settle out of court on claim of inefficacy in order to
avoid adverse publicity. Whether the court case is won or lost, the producer
who forces litigation will lose customers. Therefore, a major guarantee of
efficacy of agricultural chemicals is offered by the industry itself, which
conducth extensive research to back that assurance.
B. Industrial and governmental use . Industrial and governmental users
are often protected from economi.c loss by signed contracts. The possibility of
legal redress can encourage manufacturers to supply a product meeting tighter
specific: tions. Also, most of these users could perform their own quality
control cheeks to guard against improper formulation and conduct some of their
own biologi cal tests to make sure that the purchased pesticide is effective
against the particular strain of pest. Finally, employees in many industry
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and government opcr tions are well enough trained to determine if a product
has been e11’ctive.
C. IJome and garden use . The application of home and garden pesticide
products involves less risk of serious problems than use of pesticides in other
sectors of the economy. Potential effect on humans are limited because
of Ihe reduced strength formulations prepared for use in the home. Potential
environmental effects are limited by both the formulations sold and the
relstivclv small volumes released into the environment at any time.
Consumer protection is the major rationale for regulating home and
garden icstieides. Since the home and garden market tends to be highly
competitive, any price advantage will enable a producer to capture the market.
Therefore Producers are encouraged to develop products with marginal amounts
to active ingredients.
Small consumers often have difficulty determining if the product pur-
chased is controlling the pest. As the least informed group of pesticide users,
they know less about the problems they are attempting to control and are
probably involved in more misuse than o ther groups. Even when lack of control
is apparent, most consumers will rarely seek legal redress because of the small
volume and minor individual cost involved. When complaints are filed, proving
that products are inherently ineffective when used as directed is diffici lt. For
these reasons some producers of home and garden products could be tempted
to formulate less effective products. Advertising might also be used to convince
the consumer to purchase a less effective product instead of the more effective
hut less publicized alternative. Private and public consumer protection services
have not yet been active in evaluating pesticide products.
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rihe magnitude of the problem is limited by the fact that many garden
products are essentially agricultural chemicals in smaller packages. Although
very few tests have been conducted specifically on these products, some degree
of effectiveness is assured by the intensive testing of the active ingredients. rphe
major problem is with fungicides and disinfectants used i.n the home, since these
sensitive compounds can be rendered ineffective with very minor changes any-
where in the production process.
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fli. EPA REGTJLA TORY_PR(X;RAM
l3aseil on F FJtA, EPA attbmpts to ensure that a pesticide product,
when used as thrected, will satisfy the legitimate expuetations of the applicator
without causing unreasonable risk to man or to the environment. The first
step in the efficacy control process is registration, which includes a review
of the efficacy data submitted by the applicant to validate the claims made for
1.he product. The second step of the control process is surveillance at the
producing establishment, where product samples are taken. Similar sur-
veillance at the marketplace comprises the third control step. During these
inspections, samples of products may be collected and sent to EPA laboratories
to be tested chemically in order to determine their composition. Some samples
are then sent to other EPA laboratories for biological testing to evaluate
pesticidal properties. This section examines EPA s implementation of these
control mechanisms designed to keep ineffective pesticides off the market.
REGISTRATION
A. The legal requirement for registration . Section 3(a) of l 1FRA, as
amended, requires registration with EPA of all pesticides used in the United
States. Section 3(c)(5) contains the conditions which must be met before
registroticn is granted, including those that establish EPA ’s responsibility to
insure that pesticide products are effective when registered:
“The Administrator shall register a pesticide if he
determines that ... (A) its coh position is such as to warrant
the proposed claims for it; ... and (C) it will perform its
intended function without unreasonable adverse effects on
the environment
Further, under Section 3(f)(2), registration is prima fade evidence of
compliance with the registration provisions of the Act. Therefore, regardless
of how EPA attempts to ensure efficacy, registration itself is an indication to
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eoci;urncrs that the product will perform its intended function.
13. Ti -ic registration process , The Registration Division is responsible
for product registration. Registration applications are first sent to the Product
Control llranch where a two part file symbol is assigned. The first part of
tl ie symbol identifies the registrant, while the second part designates the specific
product. The symbol does not provide any indication as to the type of product
(insecticide, fungicide, etc.) or its expected use (agricultural, indoor home
use, etc.).
After receiving a file symbol and a “product jacket” (piotective folder),
the basic data submitted by the applicant’is sent to the Reviewability Evaluation
Team, which determines if the application is complete. If the application is
in order, the basic data is sent to the Chemistry Branch. Scientists review
the formula and physical properties of the product to ensure that they are
consistent with the known characteristics of the chemicals used. In cases
where use of the product could result in residues on food crops, tolerance
levels, which specify maximum allowable residues on the food product, are
established in conjunction with th? Toxicological Branch.
The application and data in support are sent from the Chemistry Branch
toone of the fifteen “product manager teams” knowledgeable about a specific
chemical group. This group compares the applicant’s data with similar
products already registered. If no major differences or unusual char cteristics
are discovered and there is sufficient indication that the product will be safe
and effective, it is approved for registrationì and receives a registration number
to replace the file symbol. In cases concerning a new active ingredient or
new use, a more exhaustive review is conducted by the Efficacy and Ecological
Effects Branch and the Toxicological Branch.
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When the review confirms that all essential information has been
reported and that tIle product meets established standards, the product
call he granted regb tration. This rarcly happcre on the first application.
Data is often in .on ;plete or inconclusive, and occasionally is questionable. In
these instances the manufacturer is asked to clarify the existing information.
or to submit additional data.
The average product i_s submitted and goes through the review process
two or three times before the application can be considered acceptable. In
most instances a elativcly minor label or formulation change is sufficient
to correct the problems preventing registration. Few products are ever
completely denied registration, although many are not granted registration
for all initially requested uses.
C. Success in keeping ineffective products from being registered .
There is no good method of identifying the number of ineffective
prodilcis that are currently registered. Cancellation actions are not
a reasonable measure because even when a problem product is identified
the usual procedure is to appropriately modify the label rather than
completely take away the registration. Unfortunately a system for
recording the number of product and label changes ielated to efficacy
does not exist. An unpublished study of EPA enforcement actions indicates
that over ninety percent of registered products are effective.
P. Process recommendations . Several minor changes in the registration
process appear warranted:
1. Preregistration testing. In a 1974 report to Congress, Pesticides:
Aclioris Needed to Protect the Consumer from Defective Products , the General
Accounting Office recommended establishment of procedures for preregistration
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t’; ’din of ‘ls ;e of p ;1 Lcicles with high incidence of problems with effective—
Al thou l t’ espo ;c from EPA was u ’tclU(lCd in the report to indicate that.
the Agency was prepori.ng a comprehensive pOlicy on efficacy testing, the effort
was not con)pleted. Consequently, no definitive criteria have been developed
for lccting which pesticides, pesticide chemical groups, or pesticide uses
should be emphasized ‘in testing.
Although the Registration Division currently requests the EPA biological
laboratories to conduct. preregistration tests on some products, the scientists
interviewed f r this paper were not in unanimous agreement on which products
are or should be examined. Developing a specific policy for preregistration
testing of selected pestiricle groups would help to provide timely review of
troublesome products.
2. Criteria for review of registered products. Registered products
are occas onaiiy examined to, check that the product still conforms to the
requiromenis for registration. The major portion of this effort is a cost!
benefit review, performed by the Criteria and Evaluation Division to
determine if the benefits provided by the use of a registered pesticide
are sufficient tb outweigl the risks such use entails. ‘Social, economic
and environmental factors are considered in these reviews. The reviews
arc triggered by evidence of hazard, residue problems, need for
standards or protocols and other problems.
Some priority ranking of the products to be reviewed is obviously
necessary, since the resources to examine all registrations are not
available. The Suspect Chemicals Rcyiew Committee has established
criteria for hazard evaluation, but thus far there are no specific guide-
tines for when an efficacy consideration should initiate a cost/benefit
review. A formal policy would better guarantee that marginal products
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are reviewed and app cipriate action taken.
:t. illo v-ui system Ofl laboratory tcstin 1 . The EPA biological.
labnratorws evaluate f)estieide products to determine efficacy; safety, to
man, plants arid animals; and adverse effects upon the environment.
Products are selected for evaluation by the Regions, the Registration Division,
Pesticides Enforcement Division (FED) and OPP biological laboratories.
The product manager teams in the Registration Division apparently are not
autoniaiically provided with test results, although the P oduct Control Branch
of the Division receives all laboratory reports. Consequently, in some
cases where the results of efficacy testing have indicated that detailed
review or even cancellation is in order, the personnel responsible for
initiating such actions have not known about the problem. The situation
could be improved by notifying the appropriate product managers of relevant
studies, and requiring the product managers in turn to report on actions
taken. A follow-up system on laboratory testing would assure that each
biological test conducted resulted in appropriate action.
4. Efficacy action information system. In order to obtain a more
complete pitture of the kinds and frequency of efficacy related registration
actions taken, a record keeping system should be established. All product
changes, label modifications, or cancellation proceedings resulting from
the ineffectiveness, of a product would be entered into the system. This
would provide OFF officials with a better basis for directing program
activities.
SURVEILLANCE AT THE PRODUCING ESTABLISHMENT
A. The legal requirement for surve iliance . Section 7(a) of FIFRA,
as amended, requires registration with EPA. of all establishments producing
pesticides for use in the United States. Section 7(c) requires registered
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producers to inform the Agency annually of the types and amounts 0
pcsi.i.cides produced, sold and distributed. Section 9 authorizes EPA
employees to enter producing establishments to inspect and obtain samples
of pes ieides released for shipment and to examine the collected samples
to determine whether they comply with the provisions of the Act. The
Pesticides Enforcement Division of the Office of Enforcement, in conjunction
with the Regional Offices, is responsible for carrying out th ese sections
of the law.
Inspection of producing establishments is necessary to meet the respon-
sibilities described above. It is also critical to the effort to remove ineffective
products from the marketplace since samples ollected during these inspections
can be evaluated for effectiveness at EPA biological laboratories. A major
advantage of surveillance at the producer establishment is that product batches
which have not yet been widely distributed can be analyzed for deficiencies.
13. The surveillance process . The Regional Offices have conducted
inspections ofproducing establishments since July 1973. Each Region main-
tains a staff of approximately five inspectors who periodically visit selected
manufacturers nd formulators. Although the Pesticides Enforcement Division
has suggested that target establishments should be selected on the basis of
information about products, the Regions have indicated that criteria
4’
relating to the producer is more often usedT Generally, target establish-
ments are selected using some combination of the following criteria:
• Producers known to have marketed violative products.
• Newly registered establishments.
• Establishments which have never been inspected.
• Establishments not inspected in the past two to three years.
41 All five Regf&ñs contacted in a telephone survey so indicated.
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o ESt31)1 1)Ji) cuts prOducing newly registered products.
o Randomly sd ecled rcgintcred c stahl isliments.
For e ti 1,1i ;hment which prOduce more than one product, similar
criteria are uEed to select which product to sample. While there is no
standard procedure followed by the Regions to determine which
product or products to select, most inspection teams use some
combination of the following;
• Products which are obviously violative (as when a label does
not match that which was registered).
o Products which have never been sampled.
• Products not sampled in the past two or three years.
• Newly registered products.
• Products with a high degree of potential hazard.
• Products produced in large volumes.
• Products with histories of extensive violation (in some Regions all
disinfectants are sampled. for e mple).
• Products sampled according to a random process.
The PestIcides Enforcement Division has in the last two years compiled
a guidance package to assist the Regions to establish parameters for the
surveillance process. To develop a factual basis for further guidance, FED
requested the Regions to sample products chosen on a random basis (in
addition to the regular sampling). The results of this study, known as “the
Keller Report,” will provide better indications of the problems of violative
pesticides and the methods of enforcement most likely to minimize these
problems.
The iiispcction teams make a concerted effort to visit the establish-
rnents at the times when the products are being formulated. This is
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often difficult becau e pesticide products are manufactured seasonally.
Forcxamp!e, an inrpectjon during January through March might result
in the s unpiing of o i].y the agricultural products produced during those
months, while products produced at other times would be sampled only on
return si.ts. Unfortunately, such revisits are sometimes not made.
CoBected samples are sealed and idei iified with a sample number
and shipped to the Product Analysis Laboratory which services the Region.
There are four of iii ese laboratories for the ten Regions. Chemical analyses
a e th ii p.n formcd to determine if the product conforms to the statement
of ingredients on the label. Products found to be adulterated or misbranded
arc referred back to the Regional office. The Region can initiate enforcement
actions to remove the violative product from the market and can also initiate
civflpr criminal proceedings against the producer or distributor.
Saniple& found to he properly formulated on the basi.s of the Product
Analysis, Laboratory tests can be sent to the chemical and Biological
Investigation Branch (CBIB) of the Technical Services Division, which has
laboratories in Corvallis, Oregon and Beltsvile, Maryland. Selection of
samples to be analyzed for efficacy in these laboratories is the responsibility
of the Registration Division, the Regional Office and the TSD laboratory
supervisors.
C. Success in inspecting producing establishments .
Discussions with several EPA QfficialS have led to the conclusion that
the number of violative products discovered is low relative to the number
of establishments inspected. Unfortunately, data necessary to evaluate
the success of producer surveillance is not readily available. Neither
the Office of Pesticide Programs, the Pesticide Enforcement Division of
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the Office 1 t ngorc(’( )e1It nor the Rer iona1 Offices regularly compile such
itforrnaiion. PET) 1 ; conducted a .study of randomly selected products
and is aw iling ’ the fi.n l report of ti- ic contractor.
1). Pi’OC ’OSS l c’cc)Fnmefldations.
- 1. Criteria for selection. PED should continue to develop and effectively
con ’Inumcaie to the Regions guidance for a consistent nation—wide producer
SUrVeiJl3nCc program. Such guidance is critical to the efficacy assurance
program because the producer surve .liance program gathers most of the
sarnp)e tested in the biological laboratories. OPP laboratories should convey
their needs concerning the sampling of specific products to FED for inclusion
in the guidance, since without such criteria, there is no assurance that the
products most likely to be defective will be examined. Some Regional ariation
in the surveillance program is acceptable because of the seasonal production
of pesdicides, 1 ut this variation should be based on defined criteria. As presently
conducted, there is little assurance that all producers will be inspected or
that all products will be sampled, even though these are goals of FED. The
wide range of criteria used by the Regions suggests either a lack of adequate
guIdance from or a communication problem with Headquarters.
2. Management system information. OPP and PED should cooperate
on reaching a formal determination of the desired objectives of the FED
surveillance program, since sample collection is critical to the biological
testing program operated by OFF. At the same time,’ data should be
collectcd on the results of the surveillance, including the number of violative
producers and products discovered and the numher of corrective actions taken
as a percentage of the number of inspections made. This data can be used
to determine the major categories of violative products and thereby assist
both PFfl) and OPP in developing guidance and establishing priorities.
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3. Reinspecti.on. No formal follow-up system exists for inspection
vi 1t . When a nla]lltfacluring esthblishment is inspected, those products
not av fl able obviously cannot ‘be sampled. The inspection teams usually
do not make speciil trips back to the establishments to take samples
because of limited transportion funds. Criteria should be developed for
follow-up sampling of such establishments.
4. Availahilityof labels. Regional inspection teams require copies
of approved labels for products to be inspected, in order to compare with
package labels anc assure compliance. Access to label copies is apparently
difficult because of Headquarters filing problems. app should revise its
filing and storage procedures to correct this.
MARKET SURVEILLANCE
A. Th legal anthorization for surveillance . Sections 8 b) and 9(a)
of FIFR.A, as amended, authorize EPA to inspect establishments where
pesticides arc held for sale and to sample the pr ducts found. Market
surveillance can discover a number 0 violations, including unregistered
products, improperly labeled products and products which have deteriorated
beyond the point where they can be effective. Additional testing performed
on samples collected by market surveillance can discover adulterated and
biologically ineffective products as well.
B. The market surveillance process . As presently conducted,
market surveillance is a minor part pf the total surveillance program.
While there is Regional variation as to the relative iumber of market
and producer surveillance inspections, the Pesticides Enforcement
Division estimates that only about 10% of the annual inspection visits were
at retail establishments.
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‘rim loc;nisti’y and biology laboratories,: are dependent on the surveillance
- ss for product ampIes. For this reason, it is critical to the efficacy
c program that survcilloncre provide adequate product samples
well as meet ihc’ oil’er responsibilities of PED. Like producer surveillance,
r cillance is conducted by the Regional Offices. Explicit criteria
) \c i oI } een deve1op ’cl to assist In the identification of the distributing
stcbl-:l ;c i tt- to ic - r:ct, the types of products to sample, the number of
: ucpics tr or the follow--up actions to take when violations are discovered,
C. Process recommendations .
1. Notification of producers. Producers should be notified of all
iciects fc. n .i in samples of their products so that they can take corrective
ichoiis w m possible. Although the Regional Office which collected the
ic clod sample regu)arly receives copies ofthe test results, many Regions
rio not: automatically send these to the producer. Such violations should be
the basis for enforcement actions. However, even if there is insufficient
c ’ idonce for use in court, notification should encourage the producer to
correct the problem.
2. Management system information. OFF and FED should reach a
formal agreement on the objectives of the surveillance program. Data
should be collected on the results of the program, so that EPA program
11 ian agers can determine which products are most likely to be violative.
ilils information is not now aggregated in useful form and in some cases
is not available at all. The sampling and testing criteria are therefore
not established on the basis of specific information.
3. Criteria for selection. OPP should assist PED in the develop—
mont of guidance for a consistent nation-wide market surveillance
program. Such assistance should include but not be limited to the
pFOV;.: -;i,on Of a list of suspect products to sample. Regional variation
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25
shou id h based on acceptable, defined criteria. As presently conducted,
survc 1hwcc appears haphazard, with little assurance that troublesome
prodiict are sampled. Also, the lack of selection criteria encourages abuse.
Sorut’ est bhshmcnts might bc bothered by continuous inspections while others
might iiever be sampled.
POSTIIEilSTRATION EFFICACY TESTING
A. The testing pross . Almost all of the biological testing conducted
to evaluate pestic dal properties of selected products (“efficacy testing”)
is performed on previously registered and marketed products. Testing
of I)rOduct samples collected during manufacturer or market surveillance
occurs in laboratories at Beltsvile and Corvallis under the supervision
of scientist from the chemical and Biological Investigations Branch (CBU3)
of the Technical Services Divi ion.
Postregistration biological testing has two purposes, an evaluation
of the effectiveness of a particular product and a check of label claims.
Sample selections are usually made by Regional enforcement personnel
or CBJB laboratory supervisors, but this does not preclude the Registration
Division, the Pesticides Enforcement Division or States from requesting
evahuition of product samples.
Although no established criteria have been prepared to assist in
selecting the pesticides to he analyzed, the selection has been based on
• Whether or not there has been a history of.trouble with that
product or similar products.
• Whether or not the product has been tested previously.
• Whether or not new claims are being made for the product.
• Available laboratory capabilities.
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The laboratories also test all samples of vertebrate pesticides collected
by the Hegiotis.
Ap iroxi riateJy eighty samples per month are tested for efficacy by
the C flJT3 laborntories. Pharmacological testing is conducted on an additional
forty five sampl.es each month. Reports on the testing results are sent to
the Registration Division and the Regional Office which collected the sample.
II. Test results . According to •C records, since July 1, 1972,
2085 different products have been tested for efficacy at EPA biological
laboratories (see Table I). Of these, 396 were found to be biologically
defective (inefficacious) in at least one sample. Determining that a single
sample i defective is not sufficient to prov that a product is inherently
ineffective. The sample analyzed might have been taken from an isolated
production batch which was improperly formulated, or the test conditions
might not have duplicated use conditions. Therefore, in most cases the
product managers in the Registration Division require that more than one
sarnp!e be found defective before any’action is taken.
5/
TABLE i
FINDINGS OF EFFICACY IN PRODUCTS
ANALYZED FROM JULY 1972 TO JUNE 1975
Number of Products
A B C D
Analyzed Found Defective Eetests of B Tested Only
at Least Once Once and
Defective
2085 396 110 286
5/ Table F as mpiIed by the study team from the file of records at the
i3113 headquarters at the Be]tsvifle laboratories.
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In s [ )itc of the need for aciditiorta ) evabiation of sorn products, less
than t vciif.y eight per ccnt (110 of 396) of the defeetlyc products were tested
more than once. Autoioatic fo1low up does not occur, and additional testing
i:’ (J( pCtIdC(it on rcquc ;ts from the Regions, the Registration Divigion or the
i’e hnical Services Division.
While biological testing can be a vajuable toOl for evaluating efficacy,
there are several reasons why the biological laboratories cannot always
determine product efficacy. The obvious difficulties are:
1. Standard test protocols do not exist for some kinds of roducts, such
as dog and cat repel!ants. Without commonly agreed upon methodologies,
test results may be subject to various conflicting interpretations.
2. The testing process can be costly and time consuming. This
problem is magnified because meaningful conclusions can be drawn only
after repeated tests.
3. Crops are seasonal. In some cases, tests can be conducted on]y
during a limited season of the year. If adverse weather conditions, equipment
breakdown, or other factors cause delay, an entire year may go by before
another test can be attempted.
4. Specialty crops present difficulties. Commodities such as
pineapples, sugarcane, rice, raisins, macadamia nuts, wild rice and
many, many others are grown in certain limited climatic or geographic
areas using unique cultural and harvesting practices. It would require
tremendous resources to conduct tests with such crops.
5. Pesticides are applied by many different methods, ranging from
aircraft (both fixed wing and helicopters) to mistblowers, to sub-surfacE
injection, to band treatments, to irrigation, metering, etc. To be valid,
testing must duplicate use conditions. EPA does not Initiate cancellation
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3. P ’udtct 505-la Notice of Inlent to Cancel, has been issued.
I 3CG-• l 9. Rgi .tratit was asl;cdto reformulate the
i’ 1uc1 . Tn t o’ ly t ;1 s nice rcfu nu lation, product performed slightly,
ti:1u }: IV)( un:! ( c •pthbiy, b:iow efficacy standards.
5. Product 3487-19. Producer was requested to submit additional
information. tdtl oigh no response has been received, no follow-up action
1 u-; 1)e(w tuLeli.
6. Product 3696-71. No action taken.
7. Product 5602-129. Producer was asked to submit new efficacy data
p ‘iar to cregis tration.
8. Product 6900-63. Registration has been cancelled.
9. Product 13794-2. No action taken.
in casc ; 1, 3, 7 and 8, Registration Division action has been satis-
factory. in cases 2 and 5, at least eight nibnths have passed since the
prothicer was notified. The Product. Managers have indicated that
No.c”s of Intent to Cancel should have been issued, but in both cases the
fotder had been returned to the files and forgotten. In cases 6 and 9 nc
action wus initiated by the Registration Division even though strong
C\1(lt:hCC existed to indicate that the product was defective in some
resf) :Is. Finally, although some action was taken in case 4, the product
still does nol meet standards.
In summary, the CBIB file survey indicates that the current program
of postregistration efficacy testing is not providing adequate protection. Proof
thzit a product is ineffective depends on repeated tests with different samples.
Such proof is lacking because no automatic retesting occurs. Even when a
product is found l.o be inhcrentJ.y defective, the actions taken by the Registration
Divm ion are neither timely nor complete. If these nine products did not receive
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urOnLpt, (q tC ;dtution, there is iittleassuE tnce that other product arc
pf01)eIiY h uu1Jed.
]). Jerommen’la Lions .
1. Automatic retesting. When CBJB completes a test and the sample
i ; deterin ned to be defective, the laboratory should automatically request
additional samples from different batches of the same product. The
llegional surveillance teams should be responsive to such requests.. Only
by conducting repcat tests on violative products can the laboratories provide
timely rccommendations to PED and RD.
2. Review policy. The Registration Division has no standard policy for
reviewing reports received fromCBIB laboratories. From the Interviews
conthicteci it appears that no clear guidance has been issued about who has
what review and decision-making responsibilities and when they are to be
e eeutod. The recent changeover to product manager teams may bereèpon-
sil 1e for ;ome disorganization, Now is the best time for standardizing the
process so that prompt, consistent and necessary registration actions can
he compleled. For example, every laboratory report received by the ID
coordinator should be sent to the appropriate product manager, an expert on
the particular chemical family who is responsible for the product’s registration
file. He should distribute the report for examination and see that all necessary
aclion$ arc taken.
3. Tickler file. The file study discussed above sufficiently demon-
sirates the need for better record keeping procedures. A. file listing what
steps have been taken to obtain more efficacy information or to Initiate the
cancellation proccss should be maintained to facilitate timely follow-upaction,
4. llo: c arch contracts. OPP should contract with State Agricultural
Experiment Stations or similar rescarch groups to test agricultural
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1 )estici( ( fer efficney arid phytotoxicity on local basis. Although such
iest 3 mi ui. e ne i . d i;r’requertly, the capability should be avaiiabie on
(Jern:ln(1. in such te ; .ing the product shotiJd be identified only by. a code number .
and the j) r aruiar usc, and blaini tO be tested shGuld be specified.
5. T)cvelopment of standard test methods. Increased emphasis on the
dove1.opn erii of standardized procedures for evaluating the efficacy of
pe :ticidc’ preductc, is tron 1y recommended. Uniform test protocols can
reduce NP s burden in a number of ways. First, producers and researchers
could conduct acceptable studies more easily. Second, EPA*s :r ,jewers could
bolter review submitted. test data. Third, EPA’s scientists could more easily
(luplicate t ;ts in laboratories. Fourth, EPA’s enforcement efforts would b.e
hampet--d lt’s by the problem of comparability of test results based on different
procedures.
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0!’: IONS
l c’ ! 1WP nave dC rthCd the potential problems hat Lie Ua or
iit l’e( t vr j . tjcidO ‘oiucts could cause and EPA ’s regulator pr ‘am to
limit 1h.n , Based (; kcu5SiOflS with per3onnel from each of th \
of the Office of Pesticide Programs, the Pesticides Enforcement
the l egio;. al Officc an i a number of knowledgeable groups outside th Agency.
jhi sc c1.ioi e: mines nptioris for’ each of the five major elements In th.ConlrQI
;y tern: prcregistration tcsting, data review, producer surveillance, ma. ket
SIIrVCj11 ! II CC, and postregistration testing. The study team has made
re eomrnc idations in each area,,
Pi EflEOI JTRATiON EFFICACY TESTING
Preregistration efficacy testing can provide an Independent cieck on
the accuracy of the efficacy information submitted with the request for
registration. A comprehensive program of preregistration testing would help
assure that no ineff:c ive products are registered by mistake. Of course,
ueh testing cannot impact effectiveness problems resulting from unregistered
prcducts, shelf-deterioration, developed resistance, quality control, or minor
changes. Such testing could be considered a service to producers, since
suggestions from the laboratories often result in greatly improved products.
Persoun 1 in CBIB have indicated that they believe this is the essence of
preregist t dion evaluation.
Preregistration testing is currently conducted on limited classes of
products (e.g. sterilizers). A more comprehensive program might involve
either the testing of sonic new registrations to provide an Incentive for the
registrant to do thorough tests, the testing of all new registrations to ensure
that subniitled data is accurate, or the testing of all new active Ingredients to
develop inlnrmation against which later product registrations. an be. compared 1
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c flece i 4 endatio n The prbnary purpose of preregistra4n.teS tinb
is l- pri’vent Lhc reI) istr:1tLou of in . ffeetive pesticides. JTowov , the study
tezi, found Ihat. c toneeu iegistrationis not a major source oi efficacy.
Mor’ov :r, even with prcrcgistration testing the possibility of iin istako exists
in dealing with ‘oducts for which standard test protocols have p Ot been
dcvclopcd. Finally, no e>:tsting evidence indicates that EPA, prej ,.egistrati
tc S i keep any incffcctive products off the market.
The other stated rationale for preregistration testing, to help producerg
improve products before registration, does not appear to be a proper use
of government resources. EPA should not be providing a service, such as
prohict improvement, which is actually a basic responsibility of the
Jn [ niufacturer.
The study team therefore believes that preregistration testing is an
unnecessary aspect of the control program. When additional data is neede4,
EPA should request the producer to provide It. In the rare case where a
manufacturer is suspected of data falsification, EPA should not seek to
perform the tests but should Instead require the producer to obtain a,
second, independent validation of the effectiveness of his product.
DATA REVIEW
Data review is the evaluation by Registration Division scientists of
information supp]ied by an applicant to support a registration . request.
This ontrol element has two parameters, extent of review and number of
reviews.
1. Extent of review. Three levels of data review are possible.
First, a simple check can be made to ensure that all necessary data
required have been submitted. This relatively Inexpensive option has
as a major drawback that no evaluation of data occurs. Consequently,
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34
if an applicant submitted inadequate data in the proper format, it is
unlikely he would be caught. As a second option, the data could be
compared with data from similar products already registered. Third,
a formal and Independent evaluation of the data could be made.; This
mO8t expensive option would provide the best assurance of próduót
efficacy at the time of data review. The benefit of thiS assurance is
questionable since, as stated earlier, much of the problem of pesticidi
Inefficacy surfaces only on the production line or on the she]!. A more
extensive data review would not necessarily solve these problems.
2 • Number of applications reviewed. The data revieW can cover
aU applications, as is currently the case, or only some selected subset
(by class or random determination).
• Recomniendation . Data review is and should continue to be the
primary method of promoting product efficacy. Assuring that the registrant
has carefuUy documented effectiveness is the most Important mechanism
for keeping poor products off the market. That so few Ineffective pesticides
are marketed is attributable to this review and the producers’ Incentives
reinforced by basic market pressures. The data requirements In the
Section 3 regulations and guidelines describe the best available methods
for testing the efficacy of pesticides. Registration Division review of the
submitted data is generally sufficient to determine if a product will or will not
perform as Intended. Because the review also includes an appraisal of the
production process, quality control problems are reduced. Only products
with suspect or new active ingredients should be subjected to rigorous exami-
nation. However, the routine data review should continue for all products.
Further investigation could be done selectively, as required.
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PRODUCER ESTABLISHMENT SURVEILLANCE
Samples of products packaged for sale can be collected during visits to
producer establishments. Later analysis can determine If they conform to
registration requirements. A program of producer surveillance could be
instituted at four levels:
1. Comprehensive producer surveillance. A comprehensive producer
surveillance program would entail periodic Inspection of all establishments,
with sampling and chemical testing of all products. Such activity would help
ensure that all products were effective when packaged for sale but would
not prevent problem i caused by mistaken registration, developed resistance,
or shelf deterioration. Since available data indicates that most ineffective
products result from errors in the production process, a comprehensive
program could significantly reduce the number of ineffective pesticides. The
cost of a comprehensive program would be large, requiring additional
inspection teams and laboratory facilities.
2. Random surveillance. Random surveillance of producing establish-
ments, as c rrently conducted, provides reasonable assurance that adequate
records are kept. Sampling products at the establishments provides a IiTnited
control over production of ineffective products.
3. Limited producer surveillance. A program of limited producer
surveillance could have a relatively large impact if only products with
histories of quality control or batch problems are analyzed. OPP
scientists indicate that sporicides and sterilizers often have production
problems. Other manufacturers would be inspected only if suspected of
violations.
4. No producer surveillance. Inspections could continue until deter-
mination is made that most producers were keeping adequate records. No
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36
samples of products would be taken for analysis.
• Recommendation . Producer establishment surveillance is necessary
as a deterrent to poor quality control and illegal product changes. Since
these are major causes of ineffective products, a strong producer surveil-
lance program is needed. The Office of Pesticide Programs and the
Pesticides Enforcement Division should devise a sampling schedule which
covers all products but which emphasizes suspect ones (i. e. those with a
high probability of efficacy shortcomings and those with violative histories),
Indications are that vertebrate pesticides and disinfectants are the most
likely violative groups. These products should be emphasized in the
sampling program until specific violative groups are formally identified.
All samples should be chemically analyzed to verify the registered formulation
but should not be routinely evaluated for efficacy. Producer surveillance
and chemical testing cannot prevent unregistered pesticides, pesticides
registered by mistake, shelf deterioration, or developed resistance problems.
MARKET SURVEILLANCE
Visit&to retail establishments, including review of product labels and
sampling for chemical testing, can control ineffective pesticides that are
unregistered, have deteriorated on the shelf, or have been miaformulated
by the producer. A program of market surveillance to assure efficacy
could be instituted at four levels:
1. Comprehensive market surveillance. A comprehensive market
surveillance program would entail periodic inspections of all establishments
and sampling of all products. Such activity would reduce the number of
ineffective products sold. However 1 the cost would be very great, requiring
expansion of the inspection teams and the laboratories.
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2. Random inspection. A randomly chosen sample of retail establish-
ments could be inspected for unregistered products. Other products could
be selected and then tested in the laboratories forch emical and biological
pr operties. The market surveillance program currently conducted, based
on such inspections, provides more assurance that all products are registered
than that all products are efficacious.
3. Market surveillance of selected establishments and products. If
the major remaining cause of ineffectiveness is shelf deterioration (or improper
storage contributing to it) . then small volume distributors should be inspected.
A program refle ting this consideration would inspect hardware stores and
other retail establishments specializing in sales of small packages to individual
consumers. Similar selectivity could be applied to the products sampled.
U only a few pesticide use groups are likely to be defective, then only these
should be sampled.
4. NQ market surveillance. Inspection could continue until unregistered
products are discovered infrequently. Then the program could be reduced.
No samples of products would be collected unless violations were suspected.
This option should be selected if market surveillance reveals few defective
products.
e Recommendation . Although marketplace surveillance can provide
protection from ineffectiveness as a result of poor production procedures
and minor product changes, it is more efficient to catch these problems
at an earlier distribution point through producer establishment surveillance.
The unique targets of market surveillance are unregistered products and
pesticides which have been on the shelf too long and may have deteriorated.
Since the efforts of PED have essentially eliminated most unregistered
pesticides and since there are now requirements for label dating, market
surveillance activity should be reduced.
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POSTREGISTRATION EFFICACY TESTING
Samples collected during producer establishment and market
surveillance are first analyzed chemically to verify the presence of the
proper amounts of active ingredients. Although analytical tests for
percentage of active ingredient are not sufficient for declaring Ineffective-
ness, such tests can be the basis of stop-sale or removal orders. If the
product contains the correct ingredients it may be evaluated for efficacy at
EPA’s biological laborato ries. Postregistration testing is primarily useful
in pinpointing deficiencies that cannot be regulated by the four previously
discussed controls. Erroneous registration, less rigorous registration,
and developed resistance could be discovered through testing. In addition to
the analysis of violative products to obtain evidence for cancellation actions
and court proceedings, a program of biological testing could be conducted at
four levels:
1. Comprehensive testing program. A comprehensive biological
testing program would entail the evaluation of all registered products.
Sampling could be done at the manufacturer level or the market level or
samples could be requested. Laboratory capability would have to be
greatly expanded if all products are to be examined on a periodic basis.
Additional laboratories would be needed in several geographic locations
for the proper analysis of some products, though some testing can be done
under contract. A comprehensive program could be a powerful incentive
for manufacturers to take diligent steps to insure that their products
are effective.
2. Random testing program. A testing program which evaluated the
biological effectiveness of a relatively large proportion of pesticide products
could have the same benefits as the comprehensive program but at less
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•.1 I
cost. If as few as fiv or ten percent of registered products were periodically
examined, a high level of assurance of efficacy.wouldbe provided.
5. Selected product testing. EPA’s laboratories are too limited to
compete with the large producers of agricultural and industrial chemicals,
who utilize test facilities in numerous geographical areas. Even when EPA
scientists discover an ineffective product, Llmost certainly the producer will
challenge EPA ’s testing procedures and equipment. Therefore, it might be
better for EPA to concentrate its limited testing capability on home and
garden products which are not tested extensively by the manu acturer.
4. No postregistration biological testing. EPA laboratories indicate
that 19% of the products tested for biological effectiveness might be
defective. This figure overstates the percentage of marketed products
which are defective since some of the products sampled and tested
are those suspected of violation or with histories of inefficacy. More-
over, the value of identifying the small number of Ineffective products
is further limited because sales continue during the testing period and
sometimes during litigation even if EPA tests showed it to be defective.
Since most pesticides are produced in batches that can be sold relatively
quickly (one year or so),test results usually come too late to prevent
any damage that may occur.
• Recommendation . Having a process for verifying that a product is
effective as intended is mandatory only if 1) the front-end registration.
process is not doing an adequate screening job or 2) for some other reasons
there is a major market efficacy problem. However, we believe that post-
registration testing is generally not required for either reason. The
registration process can identify and eliminate most pesticides and product
uses that are likely to be ineffective. The Section 3 test protocols and data
requirements are sufficient to ensure that producers do not waste time and
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money on fundamentally unsound products which do not meet the requirements.
Furthermore, the efficacy and safety evaluations completed during the data
review period effectively preclude the registration of suspect products.
The study team also believes that inefficacy stemming from pesticide
production and sale is not a major threat. Ineffective pesticides may be
marketed, but there is no reliable documentation to demonstrate the
need for special concern. No data was produced on the number or types of
OPP registration actions related to efficacy. In light of this and our con-
clusion that the limited threat from ineffective pesticides is the result of poor
production processes and minor product changes, which could be controlled
through a strengthened surveillance program, the study team concludes that
routine postregistration efficacy testing is not critical to the Agency, and
can be eliminated.
While all routine postregistration biological testing should be curtailed,
we wish to emphasize that some testing will remain necessary. AU tests
conducted should be based on specific requests from PED or the Registration
Division. By making these offices responsible for initiating testing and by
requiring appropriate responses, this system will assure that effective
regulatory actions will take place while testing is kept to a minimum.
This argument for less postregistration efficacy testing does not
necessarily mean that the EPA laboratory capabilities should be reduced.
We wish to underscore the recommendation on page 31 which focuses on
the desirability of developing standard test methodologies. Currently
about 50 percent of the CBIB workload involves research on test protocols,
accident and safety studies, and special Investigation requests from other
Federal agencies and States. These responsibilities can be strengthened as
the efficacy testing load is decreased.
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UNITED STATES ENVIRONMEHTAL PROTECTION AGENCY.
SUBJECT: Report on "ProtectloVi From Ineffective
Pesticides"
FROM:
TO:
Alvin L. Aim, Assistant Administrator
for Planning and Management (PM-208)
Andrew W. Breidenbach, Acting Assistant
for Water and Hazardous Materials
Stanley Legro, Assistant Administrator
for Enforcement (EN-329)
Russell E. Train, Administrator (A-100)
BATE: OEC78 1975
The Program Evaluation Division has completed a study on
protection from ineffective pesticides. The paper has been cir-
culated twice in the Agency for comments, with extensive revisions
each time. The final product reflects our best judgment of the
direction the program should take.
The report includes a series of policy and program management
reconroendations. The major thrust of the recommendations Is that
(1) efficacy testing should be conducted on a systematic basis to meet
specific stated needs of the Registration Division, the Criteria and
Evaluation Division, the Pesticides Enforcement Division and the
Regional Offices; and (2) Increased ejnphasis should be placed on
the development of standard test methods for efficacy evaluation.
With your approval we will implement the following:
OFFICE OF PESTICIDE PROGRAMS (DAA)
. Technical Services Divison is developing a suspect products
list of pesticides or pesticides uses that are most likely
to be defective. Surveillance resources will be concentrated
in these areas.
. An efficacy action information system will be established
to track biological test results as well as subsequent
registration/enforcement actions. This will be used to
keep Regions informed of these actions and will also provide
input into selection of suspect products for future sampling.
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• Contracts or basic ordering agreements for the efficacy
testing of agricultural pesticides will be negotiated with
State Agricultural Ex r1ment Stations or s111lar research
groups, as required.
TECHNICAL SERVICES DIVISION, OPP
• Preregistration biological evaluation activity will
continue at the current very low level on. requests
critical to Registration Division’s decision-making.
• Postregistratlon (surveiflance) biological evaluation
activity will be co letely aimed at supporting regis-
tration/enforcement actions on suspect products. These
products will be identified by users In the Registration
Division, the Criteria and Evaluation Division, the
Pesticides Enforcement Division, and the Regional Offices.
• Whenever a defective saiçle is found, follow-up sa les
will automatically be picked up (according to criteria
based on conta lated final action) and tested In order
to determine if there Is an Inherent problemwith the
product necessitating reqi strati on/enforcement actions.
• Efforts to develop standard testing methods will be in-
creased.
REGISTRATION DIVISION, OPP
• Preregistratlon review of efficacy data submitted by
the applicant will continue to be the principlemethod
ofassuring the efficacy of products
• An applicant will be required, as appropriate, to present
corroborative data from an Independent testing laboratory
if his product contains suspect active ingredients or could
present serious health problems if Ineffective.
• Efforts aimed at more rapid registration actions on
defective products will continue Including specific reporting
by product managers on actions taken or not taken.
• A tickler file will be maintained to facilitate timely
follow-up action.
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Work on microf liming product labels will continue and will
facilitate access to current label lnforu t1on.
PESTICIDES ENFORCEMENT DIVISibN, GE
There will be a continuation of the effort to produce
a consistent nation-wide producer surveillance prograM.
Guidance will be developed for a consistent, nation—wide
market surveillance program.
• The sampling programs will Include greater emphasis on
products with histories of deficiencies.
• Regions will receive guidance in picking up Initial and
follow-up samples for biological evaluation.
• Enforcement action will be taken against all producers
marketing products which the laboratories demonstrate
to be defective.
REGIONAL OFFiCES
• producers will be notified of all defects found in samples
of their products.
• Based on guidance from Headquarters, the Regional Offices
should impleuent improved sampling programs.
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