, United States ^Environmental Protection Agency OPA 129/9 August 1979 Inspecting Records Penalties EPA's inspections of company records will be conducted in a manner which will cause the least possible inconvenience to the company. Inspections will be sought only at "reasonable times," or when the pro- ducer is ordinarily open for business. EPA is well aware that some of the records it requires to be kept are, for a variety of reasons, particularly sensitive. EPA inspec- tors will examine these records only with the prior approval of the appropriate EPA Regional Administrator or his designated representative. This provision covers: (1) the formula of an unregistered product, a product for which no registration applica- tion has been filed, or one not being pro- duced under an experimental use permit; (2) the specifications or directions of a foreign purchaser of pesticides or devices produced solely for export; (3) records of tests conducted on humans; and (4) research data on registered pesticides. The failure to keep the required records or refusal to grant records access to a duly authorized inspector is punishable by civil or criminal penalties. Generally, any regis- trant, commercial applicator, wholesaler, dealer, retailer, or other distributor who violates the pesticides law may be assessed a civil penalty up to $5,000 for each offense. Registrants, commercial applicators, wholesalers, dealers, retailers, or other distributors who knowingly violate the law may be fined up to $25,000, or imprisoned for up to one year, or both. Distributors, Although distributors, dealers and carriers rtanlnrtt nnrl are not required to keep any records under ueaierv, ana Section 8 of tne Act tney must allow Carriers access to and copying- of any records that they do keep which pertain to the quantity, date of shipment and receipt of any pesti- cides or devices, names and addresses of consignors and consignees, and any guar- antees received. If a distributor or dealer cannot furnish the requested records, he must supply any other papers which con- tain the same information. Dealers and dis- tributors are not required to keep or permit access to any records relating to financial data, sales data other than shipping data, personnel data, and research data other than that relating to registered pesticides. The record keeping requirements of the pesticide law are comparatively simple. But they are essential to EPA's efforts to retain the benefits of pesticides while protecting man and his environment from harm. EPA is charged by Congress to protect the Nation's land, air and water systems. Under a mandate of national environmental laws focused on air and watei quality, solid waste management and the control of toxic substances, pesticides, noise and radiation, the Agency strives to formulate and implement actions which lead to a compatible balance between human activities and the ability of natural systems to support and nurture life. Office of Enforcement If you have suggestions, questions or requests for further information, they may be directed to your nearest EPA Regional public information office. EPA Region 1 JFK Federal Bldg. Boston MA 02203 Connec- ticut, Maine. Massachu- setts, New Hampshire, Rhode Island, Vermont 617-223-7223 EPA Region 2 26 Federal Plaza New York NY 10007* New Jersey. New York, Puer- to Rico, Virgin Islands 212-264-2515 EPA Region 3 6th and Walnut Streets Philadelphia PA 19106 Delaware, Maryland, Pennsylvania, Virginia, West Virginia, District of Columbia 215-597-4081 EPA Region 4 345 Courtland Street NE Atlanta GA 30308 Alabama, Georgia, Florida, Mississippi, North Carolina, South Carolina, Tennessee, Kentucky 404-881-3004 EPA Region 5* 230 S. Dearborn Chicago IL 606O4 Illinois, Indiana, Ohio, Michigan, Wiscon- sin, Minnesota 312-353-2072 EPA Region 6* 1201 Elm Street Dallas TX 75270 Arkansas. Loui- siana, Oklahoma, Texas, New Mexico 214-767-2630 EPA Region 7 324 East 11th Street* Kansas City MO 64106 Iowa. Kansas. Missouri. Nebraska 816-374-6201 EPA Region 8* 1860 Lincoln Street Denver CO 80295 Col- orado. Utah, Wyoming, Montana, North Dakota, South Dakota 303-837-3878 EPA Region 9. 215 Fremont Street San Francisco CA 94105 Arizona, California, Hawaii. Nevada. Pacific Islands .415-556-1840 EPA Region 10* 1200 Sixth Avenue Seattle WA98101 'Alaska. Idaho. Oregon, Washing- ton 206-442-1203 Keeping the Pesticides Records Straight 00 >mc £-SS£ g »§ ^3 QI 2 5 5 2 ^ CD O) n ------- Pesticide Records Chemicals have been used for a long time to control the multitude of pests that plague mankind. Over the years several hundred basic chemicals have been devel- oped and marketed in thousands of dif- ferent formulations to try to get rid of, or at least control, unwanted insects, plants, fungus growths, soil nematodes, small mammals and other pests. Without question, pesticides have pro- duced substantial benefits all over the world. They have helped increase food pro- duction and control fatal diseases such as malaria and encephalitis. But, beneficial as they are, many pesticides are toxic to the human species as well as other forms of life. Recognizing that the benefits of pesti- cides were not being gained without risk. Congress amended the Federal Insecticide, Fungicide and Rodenticide Act in 1972, in 1975 and again in 1978 to give the U.S. Environmental Protection Agency broad new authority to regulate pesticide produc- tion and use. Today all pesticides intended for sale in the United States must be registered with EPA. The old law covered only pesticides sold in interstate commerce. Records The new law gives EPA the authority to require producers of pesticides, producers of active ingredients used in producing a pesticide subject to the act and producers of pesticide devices, to maintain certain records. In September 1974 EPA promul- gated regulations which specify the scope and type of records which have to be kept, the length of time they have to be retained, and the procedures EPA will use to inspect certain sensitive records. The Agency has imposed only such record keeping require- ments as are essential to current enforce- ment responsibilities. Therefore, .as long as the records provide EPA with all informa- tion necessary to track defective or unsafe products when necessary, the records may be kept in whatever manner best suits the company. Computerized or centralized record-keeping systems are fully accept- able. These records should also help pro- ducers prepare the reports which must be filed annually with the EPA. Production Most of the required records pertain to production, batch identification, quantity, inventory, and shipments. The following records of pesticides, pesticide active ingredi- ents, and pesticide devices must be set up and retained for two years: For each pesticide or active ingredient produced: product name; EPA registration number; experimental permit number (if any); batch identification; and the amount (weight or volume) per batch. . For each device manufactured: brand name and quantity. For each shipment: brand name of prod- uct; quantity; name and address of con- signee; name of the originating carrier; and the date shipped or delivered for shipment. For each shipment received: brand name; quantity; date received; name and address of shipper; and name of the deliv- ering carrier. Shipping records must be kept even if the shipment is between plants owned or controlled by the same person. It is not, however, necessary for producers to keep records of products used in internal maintenance, extermination or sanitation programs. For EPA purposes, it is only necessary to retain the latest inventory records. Disposal, Testing and Research EPA also requires records to be maintained on the disposal of all pesticides,'pesticide active ingredients, and' pesticide containers, testing on humans, adverse environmental effects, as well as research data. This infor- mation will help EPA identify pesticides which may harm man or the natural environment. Because of the possibility of long-term impacts, records of disposal and human testing must be kept for 20 years. EPA recognizes that such a long retention period could cause storage problems. Although companies are required to keep physical custody of these records for at least three years, if desired, the firm may then transfer the records to the appropriate EPA Regional Office. Pesticides disposal records must include the types and amounts of pesticides dis- posed of, the methods of disposal, the location of disposal sites and the dates of disposal. It is not necessary to keep detailed records on the disposal of pesticide con- tainers. If a company follows a standard container disposal procedure, EPA will accept a statement from a responsible com- pany official indicating how and where disposal takes place. From then on, it is only necessary to record any deviations from the standard procedure. Disposal of pesticides and pesticide con- tainers poses not only a potential short term danger to the environment, but also potential long term hazards including the contamination of drinking water. Mainte- nance of disposal records can help prevent these hazards. For example, if there is evidence of pesticide contamination of a stream or drinking water supply, a review of disposal records might indicate the source, and corrective measures could be taken. Maintenance of disposal records should also make it possible to avoid inadvertent disturbance of disposal sites by future construction. It is, of course, illegal to test the effects of pesticides on humans unless the individ- uals have volunteered and have been fully informed of the nature and purpose of the test and of any reasonably foreseeable physical or mental health consequences. Records of pesticide testing conducted on humans by a pesticide producer, or on his behalf, must include: type and date(s) of test; name and address of subjects; the written consent of each subject; a copy of all information and instructions given to the subjects regarding the nature and purpose of the test; any physical or mental health consequences which were reasonably fore- seen therefrom; and any adverse effects on the subjects, including any which may come to the producer's attention after the test has been completed. Adverse Effects Producers of pesticides and pesticide active ingredients must keep a record of any unrea- sonable adverse effects their products have on humans, animals, plants, air, water, land or other elements of the environment. EPA needs these records to help monitor potential pesticide hazards. These records will also help determine whether a registered pesticide should be suspended, cancelled or its classifi cation changed. In the event a producer obtains information of unreasonable adverse effects after the pesticide has been registered with EPA, that information must be reported promptly to EPA. Producers must keep a record of these effects for as long as the registration is valid and the producer remains in business, or for two years after submitting the information to EPA. Research Records must be kept on the research con- ducted on registered pesticides for as long as the registration is valid and the producer is in business. Advertising EPA will monitor advertising for pesticide products to ensure that the product's use and effectiveness is being properly described. Producers are required to keep for two years copies of all domestic adver- tisingincluding radio and television scriptsof restricted-use pesticides. Guarantees A copy of each product guarantee must be retained for one year after the expiration of the guarantee. Exports EPA is proposing to require producers to keep copies of labeling used on exported pesticides and devices, as well as copies of the acknowledgement statements required from foreign purchasers of unregistered pesticides per FIFRA Section 17(a). Also, these record keeping requirements are ex- tended to producers of active ingredients used in producing pesticides. The require- ment that the producer must keep on file a copy of the foreign purchaser's specifica- tions or directions for two years after the expiration of the contract remains in effect. ------- |