PROTECTION FROM INEFFECTIVE PESTICIDES Prepared by the Program Evaluation Division Office of Planning and Evaluation Office of Planning and Management September 8, 1975 ------- 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 ------- 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 1 ------- 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. 11 ------- 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 111 ------- 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. iv ------- 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). ------- 2 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? ------- 3 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 11 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. ------- 4 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 ------- 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 2/ 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. ------- 6 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 ------- 7 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 ------- S 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 ------- 9 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 ------- lii 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. ------- 11 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 ------- 12 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. ------- 13 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. ------- 14 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 ------- 15 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. ------- 16 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 ------- 17 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 ------- 18 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 ------- 19 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. ------- 20 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 ------- 21 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 ------- 22 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. ------- 23 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. ------- 24 ‘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 ------- 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. ------- 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. ------- 27 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 ------- 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 ------- 30 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 ------- I A 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. ------- 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 ------- 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, ------- 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. ------- 35 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 ------- 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. ------- 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. ------- 38 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 ------- •.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 ------- 40 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. ------- 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. ------- -2- • 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. ------- —3— 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. ------- |