------- Chapter Nine Exhibit 9-3 Section VIII—Recommendation. The report should conclude with a specific recommendation for the appropriate future course of the case. Normally, one of two recommendations will be made: • Further Investigation. Where the use of an Investigative grand jury is contemplated (for example when witnesses are not talking and compulsory process is required), the referral will recommend further investigation. In this situation, an additional recommendation for prosecution may or may not be appropriate. If the evidence In hand provides an adequate basis on which to base such a judgment, a recommendation for prosecution under specific statutory provisions should be included. If the available evidence is not sufficient, a prosecutorial recommendation should be withheld pending completion of the grand jury work and consideration of the results. • Prosecution. If the field investigation Is complete, the conduct has been documented, and grand jury work is required—if at all—only to present the evidence and secure an indictment, the referral should Include a recommendation for prosecution under specific statutory provisions. Following the specific recommendation, the report should include the best available projection of resources necessary to bring the case to resolution. This projection should discuss investigative, technical, and legal resources and should indicate the Regional Office's ability to provide these resources. Appendix A—List of Witnesses. This section is particularly useful to prosecutors supervising the case and will frequently be used in issuing subpoenas, planning a grand jury presentation, and estimating the scope of the prosecution. For each witness, the writer should provide all available background data (e.g., name, residence, work address, telephone numbers, etc.) and a brief summary (one paragraph) of the matters on which testimony is anticipated. This section should include not only the key substantive witnesses, but also those who will establish the appropriate foundation for documentary or physical evidence (e.g., photographers, chain of custody witnesses, record custodians, etc.). Confidential Informants should not be Identified In this list. Appendices B and C—List of Exhibits and Exhibits. Copies of every substantial piece of documentary evidence in the case should be Included as an exhibit to the report* and should be Indexed to allow * Exceptions will be made if the exhibit is too bulky or otherwise inappropriate for inclusion in the report. Pollution samples, for example, will remain with the regional offices; however, copies of reports reflecting their analysis should be included where possible. FTFEA CoBpllance/Enforceaent 9-21 Guidance Ifennal 1983 ------- Chapter Nine _Exhibit 9-3 for easy reference in the main body of the report. Original exhibits or documents should not be included in the referral package"if this can be avoided. They will normally be used as evidence in trial, and should be retained in the Regional Office until other arrangements are made with the Justice Department prosecutor supervising the case. ice/Kiiforceaeat 9-22 i>i^Bncg iton^i 1933 ------- Chapter Ten Post-Settlement Enforcement Chapter Contents Page Monitoring Settlement Agreements 10-1 Enforcement of Settlement Agreements 10-1 FIFKA Compliance/Enxoroent 10-1 ------- Chapter Ten Contents FIFBA Govpllance/Enforcaent 10-ii Qildaiice Manual 1983 ------- Chapter Ten Post-Settlement Enforcement Monitoring Settlement Agreements The Agency often settles an administrative civil penalty action with a violator prior to the actual hearing* thus obviating the need for costly litigation. Such settlements under FIFRA take the form of consent agreements and consent orders. Consent agreement negotiations focus primarily on the appropriate size of the penalty to be imposed on the violator. Adjustments to the penalty are made by considering such factors as the size of the business of the person charged, the effect on the person's ability to continue in business, and the gravity of the violation. However, remedial performance as a means of remitting a civil penalty assessment is generally not used in FIFRA consent agreements and consent orders. In order to ensure continued compliance with FIFKA as well as with the terms of the consent agreement and order, the Agency performs post-settlement monitoring, which includes: • Follow-up inspections by EPA or State personnel (depending upon whether the State has primacy or a cooperative agreement, or both) as a part of routine assignments under a neutral inspection scheme; and • Ensuring that the violator has paid the stipulated civil penalty. Enforcement of Settlement Agreements Collecting fines that have been imposed under the terms of a consent agreement and consent order should be followed up on a timely basis by government personnel. The procedures and policies for collection action referrals to the United States Attorneys Office are set forth in Appendix 4. FIFKA comp-Liance/BOXorcBeat 10-1 Guidance aanuax 1903 ------- Chapter Ten Post-Settl ,t Bnf or Follow-up inspections that reveal continuing violations of a settlement agreement could subject the violator to additional civil penalty actions or, in fact, subject the person(s) to possible criminal sanctions under Section 14(b) of FIFRA. (Consult Chapter Five for the level of action guidance appropriate in these situations.) •*'• FIFKA umpi i «nre/aaro. Guidance ------- Chapter Eleven Special Considerations Chapter Contents Page FIFRA Section 7 Confidential Information 11-1 Disclosure of Confidential Information 11-3 compliance/mrorce»enc 11-1 Guidance IMMMIMI 1983 ------- Chapter Eleven Contents FIFMA Compliance/Bitorceaent 11-11 Guidance •••••••••• 1983 ------- Chapter Eleven Special Considerations FIFRA Section 7 Confidential Information* Under TIFSA Section 7 jand Its implementing ^regulations , .persons who produce pesticides or active ingredients used in producing pesticides must register their establishment with and submit annual data to EPA. Failure to do so is a violation of Section 12(a)(2)(L). Because some of the data submitted in connection with Section 7 is confidential and may be used as part of an active enforcement case, the following section on confidentiality and disclosure of information is included in this manual. Authority .Section 7£d) of -FiFfiA states: ."Any Information submitted to the of the pesticides or active ingredients used in producing pesticides produced, sold, or distributed at an establishment shall be considered confidential and shall be subject to the provisions of section 10." Section 10(b) of FIFRA states: M...[T]he Administrator shall not make public Information which in his judgment contains or relates to trade secrets or commercial or financial information obtained from a person and Section 12(a)(2)(D) of FIFRA makes it unlawful for any person "to use for his own advantage or to reveal, other than to the Administrator, or officials or employees of the Environmental Protection Agency or other Confidential Information wobmitted pxirsTxant :4t» -Section 3 of 71FBA Is rarely used in case development work. If the need to use Section 3 data arises, EPA's FIFRA Confidential Business Information Security Manual should be consulted. FIFRA Compliance/Enforceaent 11—1 Guidance tfnrril 1983 ------- Chapter Eleven Confidential Tnforaatlon Federal executive agencies, or to the courts, or to physicians, pharma- cists, and other qualified persons, needing such information for the per- formance of their duties, in accordance with such directions as the Administrator may prescribe, any information acquired by authority of this Act which is confidential under this Act." Penalties FIFRA Section 10(f) states that any officer or employee of the United States or former officer or employee of the United States who willfully discloses information subject to Section 10(b) is subject to a $10,000 penalty, or Imprisonment for not more than one year, or both. Contractors who are furnished confidential information as authorized by Section 10(e) are considered employees and are subject to these penalties. Document Control Chapter 12 of the EPA Securities Manual is applicable to FIFRA privileged information and should be referenced in matters pertaining to document control. The chapter describes the policies, procedures, and responsi- bilities regarding physical control of priviledged Information received by an officer or employee of EPA under a pledge of confidence from a person, firm, partnership, corporation, or association. Section 7 Information Procedures for Determining Confidentiality. Under EPA's Freedom of Information Act (FOIA) regulations in 40 C.F.R. Part 2 Subpart B, a procedure has been set up for determining whether Information is confidential or nonconfidential. Under this procedure, if information submitted to EPA has been claimed as confidential, the Information may not be disclosed to the public until a determination has been made that the Information is not confidential, the affected business has been given 30 days' notice of the determination, and the affected business has been given an opportunity to challenge the determination. Final FIFRA determinations are made by the Office of General Counsel.. However, program offices may make initial determinations (see 40 C.F.R. §2.204). If the program office makes the determination that the Information may be entitled to confidential treatment, the office must: • Deny any FOIA request for the Information; • Write to the affected business asking It to substantiate Its claim; and » Refer the matter to the EPA legal office for a final confidentiality determination. PIFitA tiOBpllance/anforceaent Ttt OnrlHiaiM*«» Mssraal 1983 ------- Chapter Eleven Confidential Information If the program office determines that the Information In question is clearly not entitled to confidential treatment, the program office must give notice of the decision to the affected business and, after the notice period ends, disclose the information to the requestor. Confidential Versus Nonconfldential Information* Agency determinations as to the confidential nature of Section 7 data are as follows: • Confidential Information. Information submitted to the Agency by a producer operating an establishment and deemed confidential under Section 7 Includes .the amounts of a pesticide, or if applicable, active .ingredients used-in producing pesticides that: - Are currently being produced, - Were produced during the past year, and - Were sold or distributed during the past year. • Nonconfidential Information. Information submitted to the Agency by a producer operating an establishment and deemed nonconfidential Bunder "Section 7 Jnr3u*1d00 or-active ingredients «sed In producing pesticides «old or distributed at an establishment. In addition, the following Section 7 Information is available on pesticide labels (which are available to the public) and, at the discretion of PTSCMS, is not considered confidential: - The establishment name, number, and address, and - For each pesticide or active ingredient used in producing pesticides, the product number ------- Chapter Eleven Confidential Information (Wliaace/Eaforceaeat IF* Goidanee Manual 1983 ------- Appendices Chapter Contents Page 1 Neutral Administrative Inspection Scheme .A-l Producer Establishments A-l Marketplace Inspections A-3 Restricted Use Pesticides A-3 Experimental Use Permit A-4 Books and Records Inspections A-4 2 Notices of Judgment A-5 Authority A-5 Agency Policy - A-5 . A-6 Procedures A-6 Distribution A-7 Exhibit A-l: Notice of Judgment After Seizure A-8 Exhibit A-2: Notice of Judgment of Criminal Proceeding A-9 Exhibit A-3: Notice of Judgment of Civil Penalty Proceeding A- 10 3 Sample Record Status and Permanent Abeyance Procedures A-ll Sample Record Status A-ll Permanent Abeyance (PA) Procedures A-12 Records Retirement and Retrieval A-12 F1FKA Pomp I 1 ance/BQ±orcp»Pnt A-l O»1|ilimpf Mm^i 1983 ------- Appendix Contents 4 Collection of Civil Penalty Assessments A-13 Authority A-13 Policy A-13 Collection Procedures A-13 Types and Methods of Payment A-15 Suspension or Termination of Collection Activity A-16 Referrals Procedures A-17 Exhibit A-4: Chapter 5-FCCS A-18 Exhibit A-5: Model Demand for Payment Letter A-30 Exhibit A-6: Model Final Demand for Payment Letter A-31 Exhibit A-7: Claims Collection Litigation Report A-32 5 Expert Witnesses A-69 Selection of Witnesses A-69 Procedures for Requesting Witnesses A-70 Appearing as a Witness A-70 6 Penalty Policies A-75 Guidelines for Assessing Civil Penalties Under Section 14(a) and Citation Charges for Violations of FIFRA A-77 Guidelines for Enforcing the Child-Resistant Packaging Regulation A-89 Memorandum (22 Apr 1975)—Interim Deviation from Civil Penalty Assessment Schedule A-107 Memorandum (11 Jun 1981)—FIFRA Enforcement Policy; Interim Penalty Guidelines A-109 7 Additional Sources of Compliance/Enforcement Information A-121 ------- Appendix 1 Neutral Administrative Inspection Scheme The following appendix outlines example criteria that may be applied by EPA Headquarters and Regional Offices (In cooperation with those States that have EPA Enforcement Grants) In selecting an activity for a programmed inspection. Other acceptable criteria may be used in lieu of those examples listed below. "For cause" or unprogrammed inspections, however, are :not subject ;to neutral Inspection scheme requirements. (See Glossary for definitions of programmed and unprogrammed inspections.) All programmed Inspections are conducted within the guidelines and priorities set forth in the Pesticides and Toxic Substances Enforcement Division's FIFRA Inspection Manual. Producer Establishments frffdw**r-^»*"^M•fa*****m-:<»'*<* Inspected at least /once every two years. DuBever, nbere violations of the •°ftet-jhave been observed during a programmed inspection, a follow-up Inspection is to take place within six months after the programmed inspection. These follow-up inspections continue at six-month intervals until the violations have ceased. Each Regional Office should have the following lists for each State under its jurisdiction: ;3jfc»t -of t3iose ^producer •stafaJdsfamegts :£ha£ Jiave jbeen Inspected during the past two years; • Category II—a list of those producer establishments that have not been Inspected during the past two years; and • Category III—a list of those producer establishments that have .Hhere **?-0?-a:tliOlllg FIFRA Compllance/Kiforcement A-l Goidanre Manual 1983 ------- Appendix Heutral Administrative Inspection Each list contains both the name and EPA establishment number of the producer. Producer establishments in Categories I and II are arranged according to the numerical sequence of their establishment numbers. Selection of an establishment for inspection is based upon the sequence contained in the Category II list. When a Category II establishment is inspected and found in compliance, it is placed on the Category I list in numerical sequence according to its establishment number. However, a Category II establishment may be scheduled for a follow-up inspection and placed on the Category III list if a programmed inspection uncovers a violation of the Act. Such a follow-up inspection is to take place within six months after the programmed inspection. Follow-up Inspections may continue at six-month intervals until no further violations are found. Once found in compliance with the Act, the Category III establishment is placed on the appropriate Category I list. Placement of an establishment on the Category I list, however, does not preclude the Agency from conducting a subsequent unprogrammed inspection of that establishment under the provisions of the warrants section, FIFRA$9(b), when a violation of the Act is later suspected. Ordinarily, the scheduling of Inspections Is carried out in accordance with the numerical scheme of the Category II list. Nonetheless, in recognition of the need to efficiently utilize Regional Office resources, the following adjustment factors may be employed to modify the selection: • Location of the establishment. For example, two establishments located in the same geographic area may be inspected at the same time despite their numerical position in the Category II list so long as one of the establishments has been scheduled according to the numerical scheme; • Seasonal nature of operations at the establishment; • Size of the establishment, number of employees, and probable length of time required for Inspection. For example, if only two days are available to conduct a programmed inspection, then an inspection requiring more than two days should not be scheduled at that time; and • Specific^special circumstances. For example, inspection of a plant that Is not operating normally because of a strike, should not be scheduled at that time. Any Category II establishment that is not scheduled for inspection because of the application of an adjustment factor retains the same priority on the list that it would have had but for the adjustment. The above adjustment factors are designed to promote the most efficient use of compliance personnel and resources and may affect the scheduling of an establishment inspection at any step in the selection process. FIFBA Co«pliance/Baforce»ent 1^2\ grfdgrn*i» Mmmal ------- Appendix Beutral Ad^*"-*Ptratlve Inspection Marketplace Inspections ' It is the Agency's Intention to conduct a regular inspection at each marketplace establishment at least once every four years. However, where violations of the Act have been found during a programmed inspection, a follow-up inspection is to take place within six months of the programmed inspection. Follow-up Inspections continue at six-month intervals until the violations have ceased. Each Regional Office should have the following lists for each State under its jurisdiction: • Category I—a list of those marketplace establishments that have been Inspected during the past four years; and • Category II—a list of those marketplace establishments that have boon Inspected .during ^ the past-four years and where violations of the Act ------- Appendix Heutral M*r* "*««•*•*«• *™» Inspection Experimental Use Permit The Regional Office is responsible, on a selected basis, for supervision of the experimental uses conducted within its Region. Supervision is for the purposes of observing and reporting whether the terms and conditions of the permit are being met and to determine whether the terms and conditions are adequate to avoid unreasonable adverse effects on the environment. Each Regional Office should establish its own supervision schedule based on the following list of priorities: • Permits for pesticides that are completely new classes of compounds (e.g., j uvenlle hormones); • Permits for chemicals with special potential hazard to man or the environment, such as: - Highly toxic products, - Products with a propensity to drift, - Products with high terrestrial or aquatic mobility, and - Products of a particularly persistent nature; • Permits for chemicals with previously registered uses that were subject to adverse action on the Agency's part; • Permits for those companies that have a history of noncompliance, inadequate supervision, or other indications of an uncooperative attitude; • Permits for those chemicals that may ultimately have a widespread major use (e.g., chemicals that will replace a major pesticide that has been cancelled by the Agency); and • Any other permits for which the Registration Division requests special information. Books and Records Inspections As a practical matter, the books and records inspection program should be an integral part of the establishment Inspection program. Books and records should be examined whenever a producer establishment Inspection is made; but, such an examination should not be limited to only those Inspections. For instance, books and records inspections may be made upon a specific request for certain information, or as a follow-up to an Agency stop sale, use, or removal order. UDspxiasce/aoxorceaent A—4 1^114*1*1*1* tvnnrf* 1983 ------- Appendix 2 Notices of Judgment Authority Under .Section 16.C4) of F/IEHA, xtie Adainlstrator of EPA ±a jrequired to give notice by -publication of all judgments entered to actions Instituted under the Act. The purpose of this publication is to make available to the public the results of court decisions and civil penalty proceedings involving pesticide! products and devices. A notice of Judgment contains the following information: • Responsible party; • Specific violations; • Dates and nature of the legal action; and f* "T* r Agency Policy The Agency publishes a notice of judgment for each seizure, criminal » •* sbe;>publlsbed ±n -,-vthe ^following Instances : • Seizures . When no product is available for seizure; • Criminal Cases. When cases are declined for prosecution by the U.S. Attorney; and -m. : CLvll Qj«T)1alTrr«. ««n dvll £9^tlalut« «re Kttbdranm i>y the Agency teTore the respondent files an answer. In civil penalty cases Involving a hearing before an Administrative Law Judge, the entire initial decision will be published In the notice of Judgment. FIFBA ampliance/Biforcement A-5 Qn44m~f Manual 1983 ------- Appendix notices of Judgment Responsibility The Assistant Administrator for Pesticides and Toxic Substances has been delegated, by the Administrator, the authority to give notice by publication of all judgments entered in actions instituted. Within the Office of Pesticides and Toxic Substances, PTSCMS is responsible for preparing the notices of judgment. Procedures Regional Office Each EPA Region will maintain a record of all seizure and criminal referral actions and all civil penalty complaints Issued. Each case will be reviewed after its conclusion to determine whether all necessary information is present in the file. Once an action has been completed, the Region will prepare a draft notice of judgment and forward it to the Headquarters Case Development Officer (HQCDO). To ensure completeness and uniformity of reporting, information for notices of judgment should be submitted in the format shown in Exhibits A-l, A-2, and A-3, as appropriate. The draft notices must be complete, accurate, and legible to avoid any misinterpretation of spelling, citations, etc. The proper and complete name of the firm and product Involved must be used. Because of the wide distribution of notices of Judgment, including some to the respondents and defendants, it is Important that the information reported for Inclusion in the publications be factual. The statutory references and charges to be Included for publication in a notice of judgment include all the charges made in the indictment or civil complaint. If any of those charges are dismissed, withdrawn, or dropped, the information should be included in the concluding paragraph of the notice that summarizes the final results of the action. The Regions will promptly inform the appropriate HQCDO of the termination of each seizure, criminal action, and civil proceeding. It is important that information be furnished on each case to which an I.F.&R. Docket Number has been assigned. If the case is withdrawn before the answer is filed, a negative report should be submitted to account for all I.F.&R. Docket Numbers. PTSCMS The HQCDO will review the draft notices of judgment submitted by the Regions for completeness and accuracy. Notices of judgment will be printed at reasonable Intervals, in groups of 50 or more. FUfMA Uoapliance/Eoforceaent A-6 ° Goldi ------- Appendix Botlces of Jud Distribution Distribution of notices of judgment will be made by PTSCMS, who regularly compile a mailing list of recipients of the notices. Such recipients include libraries, universities, civic groups, pesticide producers, and private citizens. Other distribution may be made by special request. uoapJOance/Enxorceaent A-/ Guidance ------- Appendix Exhibit A-l Notice of Judgment After Seizure United States of America v. 40 one-gallon jugs (Amount) more or less, of a product labeled in part HELENA BEAM) PRO-LIN WEED U.S. District Court, District of New Mexico. November 29, 1972 (Judicial District) (Date of Final Decree ) (I.F.&R. No. VI-17 _ I.D. No(s). 90829 _ .) This was a seizure action charging the product with being in violation of the Federal Insecticide, Fungicide, and Bodenticide Act, 7 U.S.C. i!36k(b) _ _ _ _ (Statutory References) The action pertained to (complete a. or b.) a. A shipment (s) made on May 2, 1972 _ , by _ Helena Chemical Company _ , from Lubbock, Texas , to Dexter, New Mexico _ , b. A product (s) held for distribution or sale on , (Date of Inspection) at _ ; _ , -«- (Name of Producer Establishment) (City and State) Charges included nonregistration. (Type of Final Decree and Disposition of Product) The Judgment Decree of Condemnation ordered destruction of the product. FIFRA Coapliance/Biforceaent A-8 Guidance Manual 1983 ------- Appendix Exhibit A-2 Notice of Judgment of Criminal Proceeding United States v. Sterling Drug, Inc. , (Name of Defendant) U.S. District Court, Northern District of Ohio , (Judicial District) Criminal No. CR 73-135 , July 26, 1974 . (Date of Final Decision) (I.F.&R. No. 1363 , I.D. No(s). 72760. 73184, 73706, & 78835.) This was a criminal action prepared by EPA Region V charging the defendant in a(n) five count information (indictment) with violating the Federal Insecticide, Fungicide, and Bodenticide Act, 7 U.S.C. 8§136j(a)(l)(B); 136j(a)(l)(E); 136(q)(l)(A); and 136(q)(l)(G) (Statutory References) The action pertained to (complete a. or b.) a. A shlpment(s) made on October 2 and 25, 1968; December 16, 1968; and July 21, 1969, from Toledo, Ohio _ • _ , to Buffalo, New York; Pocatello, Idaho; Omaha, Nebraska; and , b. A product (s) held for distribution or sale on (Date of Inspection) at ___ (Name of Producer Establishment; (City and State) The pestlcide(s) involved was (were) ROCALL BRAND SANITIZING AGENT and BARRAGE CONCENTRATED BOWL CLEANSER; charges Include: claims differed from those made in connection with registration, and mlsbranding— .MBS- JQO£ f ^ffrtlTf "fapn ncnd ac ^dJxecfiAdf^and • li«* k of aiifiiiur-r The defendant entered plea of nolo contendere to counts 1 and 2. (Give plea and list all counts.) The remaining counts were dismissed. A fine of $500.00 was levied. Ar*9 (^f ^"TICI* M>n"*l 1983 ------- Appendix Exhibit A-3 Botlce of Judgment of dvll Penalty Proceeding In Be: Steelcote Manufacturing Company EPA Region VII (Name of Respondent) September 3. 1974 (I.F.&R. No. VII-A6C (Date of Final Order) , I.D. No(s). 91563 This was a civil action charging the respondent with violating the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. ; and 136(q)(2)(C)(iv) (Statutory References) The action pertained to (complete a. or b.) a. A shipment(s) made on from to b. A product(s) held for distribution or sale on September 7, 1973 (Date of Inspection) at Steelcote Manufacturing Compan; (Name or Producer Establishment) St. Louis, Missouri » (City and State) The pesticlde(s) involved was(were) DAMP-TEX A & A SEALER; charges include: lack of adequate warning or caution statement on labels, lack of adequate directions for use on labels, lack of assigned registration number on labels, and labels bore false or misleading safety claims. (Complete summary of final results Including hearing, default, acceler- ated decision, consent agreement, final order, and amount of assessment. If withdrawn after answer, explain.) The respondent signed a consent agreement. The final order assessed a civil penalty of$1,200. FIFRA Oaapll ance/Enforeement A-10 1983 ------- Appendix 3 Sample Record Status and Permanent Abeyance Procedures The purpose of this section is to set forth guidelines for placing sample records in different categories of activity. It also gives guidance on retiring inactive records. Sample Record Status For record management purposes, sample record cases are placed in the following categories: • Active . A sample record file is considered active throughout the testing and review period until it is officially determined in writing that no enforcement action is Indicated or until all enforcement actions and correspondence have been concluded. After It feaa teen 'ggtcTaiacd that «no enforcement -action is indicated or after all enforcement actions and correspondence have been concluded, but the file needs to be retained for reference, the sample record is considered to be in abeyance status. Permanent Abeyance (PA). When correspondence is no longer being carried on with the firm, no further action is expected or ,iHT>f'ffl>> ;fnfl -tlir "o** :i*ff 'Clof^id j ''^*i* "nitf "** TlTT^d "*"** TTBrrmanrnT abeyance . "In the instance of notice of warning letters , if no reply from the firm is received within 90 days, the sample record should be removed from active status and permanent abeyance procedures Initiated. FIFKA Coapliance/Eoforceaent A-11 Guidance M^»mvf1 1983 ------- Appendix Sample Record Status and Permanent Abeyance Procedures Permanent Abeyance (PA) Procedures Types of PA PA Without Action. Refers to placing a sample record in permanent abeyance because the sample is chemically and biologically satisfactory and meets all the labeling requirements of the Act. PA With Action. Refers to placing a sample record in permanent abeyance after the enforcement action has been concluded. PA Procedure PA Without Action. If examination of the sample record reveals that no enforcement action is warranted: • Mark "PA" and the date on the face of the sample record jacket; and • On a monthly basis, the Regional Offices will notify the appropriate laboratories of the sample(s) that vas(were) placed into permanent abeyance. THIS IS IMPORTANT—It notifies the respective laboratories that the file has been closed and that the sample can be disposed of in accordance with the appropriate disposal method. PA With Action. When it is determined that no further action is necessary after an enforcement action and subsequent follow-up, then follow the above steps under "PA Without Action." Records Retirement and Retrieval The EPA records disposition program is designed to provide for the regular removal from valuable office space of all records and nonrecord materials no longer essential for current operations, and for the systematic release of filing equipment for reuse. At regular Intervals PA sample records should be transferred to the appropriate Federal records center. u>mp.u.ance/Enforcement A-12 Guidance ***"**>• 1983 ------- Appendix 4 Collection of Civil Penalty Assessments Authority Upon nonpayment of a civil penalty within the prescribed time periods, Section 14(a) (5) of the Act «pecifies that the aatter be referred to the Attorney General for collection: "In case of inability to collect such civil penalty or failure of any person to pay all, or such portion of such civil penalty as the Administrator may determine, the Administrator shall refer the matter to the Attorney General, who shall recover such amount by action in the appropriate United States district court." However, before any referral to the Attorney General, the Agency must satisfy the directives and standards for collection set forth in the Federal Claims Collection Act (31 U.S.C. $5951-953) and the Federal Claims Collection Standards (FCCS, 4 C.F.R. IS101-105 Exhibit A-4). 'general, the procedures jln the FCCS are Mndatory, but the failure of Agency to -comply -with -any provision of 'the standards -will not be available as a defense to any party in a subsequent action for collection. Policy 1CCS, • +***'. .*||p»»-y --*«-»ai«il a -•*•« collection action, on a timely basis, and with effective follow-up of all civil penalty assessments. Collection Procedures Written Demands for Payment The FCCS requires that the Agency make three written demands, at 30-day intervals, on the respondent in terms that Inform the debtor of the consequences of failing to cooperate. compliance/Bnxorceaent A-13 Guidance •«•*««•' 1983 ------- Appendix Collection of Civil Penalty Assessments The Agency's policy is to initiate the written demands concurrent with the issuance of a final order so that the third and final demand will be made on the same day the payment period elapses (i.e., 60 days after Issuance of a final order). Upon the Issuance of the Final Order. At the time that a final order is issued and served on the respondent, he or she should receive a written demand for any payment of such penalty and the length of time in which he or she has to pay it. Such notice should also inform the respondent of the consequences of falling to cooperate. Thirty Days After Issuance of the Final Order. After 30 days have elapsed, even though the payment period has not expired, the Agency will again serve on the respondent a demand for the payment and again warn the respondent of the consequences of failing to pay (Exhibit A-5). Given the possibility that the payment may be in the mail when this second warning is sent, the Agency should also make a brief apologetic statement informing respondent to disregard the warning if the payment has been sent. Sixty Days After the Issuance of the Final Order. The respondent must pay the civil penalty 60 days after the service of a final order unless a motion to reconsider has been made or judicial review of the final order has been sought. Subject to those two exceptions, if payment of the penalty has not been tendered at the end of the 60-day period, the Agency will send a final demand to the respondent for payment of the delinquent civil penalty assessment. This letter should be written to inform the respondent that unless payment is tendered within 15 days, the penalty will be referred to the United States Department of Justice or the United States Attorneys Office for collection in a district court. The letter should state that such action is routinely accomplished through a motion for summary judgment in favor of the United States and that the respondent will be barred from raising any issues as to fact or law that should have been raised in the administrative proceeding (Exhibit A-6). Follow-up to Final Demand for Payment Section 102.6 of the FCCS dictates that the Agency undertake personal interviews with the debtors when it is feasible, having regard for the amounts Involved and the proximity of Agency representatives to such debtors. It is PTSGHS policy to arrange personal interviews if it is feasible and convenient for the regional officials involved in the case. In the absence of a personal interview, the Regional Office should at least establish telephone contact with the respondent to urge prompt payment of the claim and to personally warn the respondent of the consequences of falling to pay the penalty. Good faith inability to arrange a personal interview or to establish telephone contact with the respondent should not deter the Regional Office from referring claims to the United States Attorneys Office for collection. UMp.uance/mxorcement A—14 Guidance nr****** 1983 ------- Appendix Collection of Civil Penalty Assessments Documentation of Collection Efforts The Agency should record and maintain a file of all collection efforts and activities prior to referral. Types and Methods of Payment Full Payment The most preferable method of collection is a check for the full amount owed, payable to the United States of America. Such payment should be delivered to the Regional Hearing Clerk for the Region In which the final order was issued. jTtat'al Itnonf-o Section 102.10 of the FCCS provides for Installment payments. This type of payment should be used when the respondent has demonstrated and documented an inability to pay the penalty in a lump sum. In that Section 14(a)(4) of FIPRA requires a consideration of ability to continue in business in assessing the penalty* this installment provision should rarely be needed as the issue will have been previously resolved. In the event that installment payments are Justified and allowed, such payments shall: • Be an a Tegular basis; • Bear a reasonable relation to the size of the debt and the debtor's ability to pay; • Be sufficient in size and frequency to liquidate the claim in not more than three years; and •• >-Bfi-jio ,jpnn -than S10 except under--tine••ost .jmusual f*1 TV*iMa^fTfi*??, In allowing a respondent to pay by installment, the regional attorney should attempt to obtain an executed confess-judgment note, comparable to the Department of Justice Form USA-70a. The Agency may accept installment payments notwithstanding the refusal of the respondent to execute a confess-Judgment note. Compromise of the Penalty The FCCS provide for compromising claims when it can be assured that the respondent's financial ability will not permit payment of the claim In full FIFBA Coapllance/anrorcement A-15 Qn-idimce Manual 1983 ------- Appendix Collection of Civil Penalty Assessments or when the litigatlve risks or the costs of litigation dictate such action. It is the express policy of PTSCMS that penalty assessments in final orders shall not be subject to compromise except under the most unusual circumstances. For the most part, FIFRA requires that ability to pay be considered before a civil penalty is imposed; therefore, the inability to pay the penalty should not be an issue in the post-final order stage of the civil penalty proceeding. However, inability to pay should be considered where: • The civil penalty was assessed by default, so that the respondent's ability to pay was never confirmed by the respondent in determining the amount of the penalty; or • The respondent's financial condition has deteriorated dramatically since the time the penalty was assessed. The Agency should be alert to the possibility that assets have been fraudulently concealed or Improperly transferred. The burden falls upon the respondent to affirmatively demonstrate and document any such inability. Section 103.5 of the FCCS provides that, where an enforcement policy is concerned, a penalty should only be compromised if the sum to be agreed upon will adequately serve the Agency's enforcement policy in terms of deterrence and securing compliance. For this reason, and for the reason that a respondent usually has already had an opportunity for settlement, the compromise provision should be rarely exercised. In the event such a compromise is effected, it must be authorized by the Regional Administrator for it has the effect of altering the final order. Suspension or Termination of Collection Activity Suspension _,^ The Agency may temporarily suspend collection action for payment of a penalty when the respondent cannot be located after a diligent search and/or when future collection prospects seem more promising than present actions. Section 104.2 of the FCCS provides a partial listing of sources that may be helpful in locating missing respondents. Efforts should be made to avoid any applicable statute of limitations. FIFSA Compliance/Enforcement A-16 Gaidar*"* MMMI 1933 ------- Appendix Collection of Civil Penalty Assessments Collection action may be terminated and the Agency's file on the penalty closed under the following conditions: • Inability to collect any substantial amount; • Inability to locate debtor; • Cost will exceed recovery; • Claim legally is without merit; or . • Claim cannot be substantiated by evidence. Section 104.3 of the FCCS provides further information on termination of claims. Referrals Procedures ~ General Claims on which aggressive collection action has been taken and that cannot be compromised will be referred to the Department of Justice or the United States Attorneys Office. Such referrals should be made as early as possible consistent with the aggressive Agency collection action and the standards for collection set forth in the FCCS. "Parties and minimum Amounts Department of Justice. All penalty assessments in the amount of$10,000 or greater should be referred to the Department of Justice. United States Attorneys Office. All penalty claims in amounts less than $10,000 should be referred to the appropriate United States Attorneys Office. ^ When referring a claim of less than$600 for collection , the Regional Office must emphasize to the U.S. Attorney that the referral is Important to a significant enforcement policy. Procedures for a Proper Referral wcUMtamy > should prepare the -dains t3oll«ction litigation Report (CCLR) for the U.S. Attorney consistent with the form and instructions in Exhibit A-7. A-17 tinijtm^ff Manual 1983 ------- Appendix fcrMblt A-4 CHAPTER II—FEDERAL CLAIMS COLLECTION STANDARDS (GENERAL ACCOUNTING OFFICE—DEPARTMENT OF JUSTICE) Part Foot 101 Scope of standards .——~...~. 90 102 Standards for the administrative collection of Claims, ,........,,„..,.,...,.....,...„,,.„„,„,., ........................1^. 91 103 Standards for the compromise of claims,.... .... . 95 104 Standards for suspending or terminating collec- tion action ...~......~...~...~......~..~....~~..~.................... 97 105 Referrals to GAO or for litigation Mk.MM.M.MM..MM 98 FXFRA On^pHaiM'O/Hnf"^*«*aent A-18 ^Unn**** Manual 1983 ------- Appendix Exhibit A-4 9107.1 PART 101—SCOPE OP STANDARDS Sec. 10L1 Prescription of standards 10U Omissions not * defense. tax 'dabns ex- 101.4 Compromise, waiver, or disposition under otner statutes not precluded. 10LA Conversion claims. 1014 Subdivision of claims not authorised. 101.7 Required administrative proceedings. 101J Referral for litigation. Atmioamr: See. a. 80 Stat. 309; 31 U.S.C. 982. Sorace 31 TO 13381. Oct. IS. 1966. unless Otherwise noted, f 10U Awcriptia« «f Ataariavda, The regulations in this chapter. issued jointly by the Comptroller Gen- oral of the United States and the At- torney General of the United States under section 3 of the Federal Claims Collection Act of 1986. 80 Stat 309. prescribe standards for the adminis- trative collection, compromise, termi- nation of agency collection, and the referral to the General Accounting ' Office, and to the Department of Jus- tice for litigation, of civil claims by the Federal Government for money or property. Additional guidance is con- tainmt hi Xttte «* «f the <3enerml Ae- .. f.».|fffluy ywfi^» .affr.*^! yfrf-frUidtTtrr of Federal Agencies. Regulations pre- scribed by the head of an agency pur- suant to section 3 of the Federal Claims Collection Act of 1966 will be reviewed by the General Accounting Office as a part of its audit of the agency's activities. C44 PR 22701. Apr. 17.1979] • 10L1 hA««v^ V ter shall apply to the administrative hunting of dvQ *Ja.<»«« of the Federal Government for money or property but the failure of an agency to comply with any provision of this chapter shall not be available as a defense to any debtor. 1 191.3 Fraud. >p*«*»"f« ,and lax. .daiau The standards set forth hi this chap- ter do not apply to the handling of any claim as to which there is an indi- TM* cation of fraud, the presentation of a false claim, or misrepresentation on the part of the debtor or any other party having an interest in the claim. or to any claim based in whole or in .part on conduct in violation of the antitrust laws. Only the Department of Justice has authority to compro- mise-or terminate collection action on such claims. However, matters submit- ted to the Department of Justice for consideration without compliance with the regulations in £*»------- Appendix Exhibit A-4 Chapter doinrs Coltoctfon Standards • 101.5 Conversion daiiM. The instructions contained in this chapter are directed primarily to the recovery of money on behalf of the Government and the circumstances in which Government *>»<»»« may be dis- posed of for less than the full amount claimed. Nothing contained in this chapter is intended, however, to deter an agency from ^•""•r* **fpg the return of specific property or from demand- tag. in the alternative, either the return of property or the payment of its value. 1101.6 Sabdhrbion of claims act author. isad. A debtor's liability arising from a particular transaction or contract shall be considered as a single claim in determining whether the claim is one of less than (20.000. exclusive of Inter- est, for the purpose of compromise or termination of collection action. Such a claim may not be subdivided to avoid the monetary ceiling established by the Federal Claims Collection Act of 1966. 80 Stat. 308. administrative proceed- • 101.7 Required tags- . Nothing contained in this chapter is intended to require an agency to omit or foreclose administrative proceed- ings required by contract or by law. 1101.8 Referral for litigation. As used in this chapter referral for litigation means referral to the De- partment of Justice for appropriate legal proceedings, unless the agency concerned has statutory authority for 3 own litigation, FAIT 102— STANDARDS FOR THE ADMINISTRATIVE COLLECTION OF CLAIMS See. 102.1 Aorwiive agency collection action. 10X2 Demand for payment. 1014 Collection by offset 102.4 Reporting delinquent debts to com- mercial credit bureaus. 102J Contracting for collection services. 102.6 Personal Interview with debtor. 102.7 Contact with debtor's employing acency. 1023 Suspension or revocation of license or eligibility. 1024 T|itpiffitn«m of collateral. 102.10 Collection in 1nTt*"Ti*"f" 102.11 Exploration of compromise. 102,12 Interest. 102.13 Analysis of coats. 102.14 Documentation of administrative coIleeUon action. 102.1ft ft**t"nflTf'fn 102.16 Prevention of overpayments, deltav- «]^pffyf ft*"* ittflllltt 10247 Additional admtniatraUv* coUecUon TT: Sec. 3. 80 Stat. SO*: 31 VAC. collection The head of an agency or his desig- nee shall take aggressive action, on a timely basis with effective followup, to collect all claims of the United States for money or property arising out of the activities of. or referred to. his agency in accordance with the stand- ards set forth in this chapter. Howev- er, nothing contained hi this chapter is intended to require the General Ac- counting Office or the Department of Justice to duplicate collection actions previously undertaken by any other agency. [31 PR 13381. Oct. 18.1066] • 1025 Demand for payment. Appropriate written demands shall be made upon a debtor of the United States in terms which inform the debtor of the consequences of his fail- ure to cooperate. In the initial notifi- cation, the debtor should be informed of the bagia for the ------- Appendix Exhibit A-4 §10X3 i* necessary to protect the Govern- ment's interests (e.g.. the statute of limitations (28 UJS.C.-2415)). Agencies should respond promptly to communi- cations from the debtor. Agencies should advise debtors who.diapute the debt to furnish available evidence to support thftlr con t^n M^TT" 144 FB 33702. Apr. IT. OTM B102J Collection by ofbct (a) Collections by offset will be un- dertaken administratively in accord- ance with these standards and imple- menting regulations established by the every instance in which this Is feasi- ble Collections by offset from persons receiving pay or compensation from the Federal Government shall be ef- fected over a period not greater than the period during which such pay or compensation h) to be received. See 5 U.S.C 5514. (b) When the head of an agency, or his designee. pursuant to 5 U.S.C. 5514. 5522. 5705. 5724(f). or other stat- utory authority, seeks to collect a debt by offset against accrued pay. compen- sation, accrued benefits derived from federal sendee or tmmtnt ot "Government employee, a member of the armed forces, a Reserve of the armed forces, or a present or former employee of the U-S. Postal Service. the agency to which the debt allegedly is owed will accord such debtor an op- portunity for a pre-offset oral hearing when: (1) The debtor requests waiver of the Indebtedness and the waiver deter- ^MmSttf^e-nt" when "the tedlvld- ual requests reconsideration of the debt and the head of the agency or his designee determines that the question of the indebtedness cannot be resolved by review of the documentary evi- dence, for example, when the validity of the debt turns on an Issue of credi- bility or veracity: Provided that, where paragraph of this sec- tion terminates, and the creditor agency determines that: (1). Amounts, accruing to the debtor upon such termination are available for offset in satisfaction of the alleged indebtedness, (ii) such amounts would not be available for offset subsequent .to termination and (ill) the time prior to termination does not permit a ore- offset hearing, the agency may with- hold from amounts nffcr"lT*g to the in- dividual upon termination, a sum not greater than that of the alleged in- debtedness and, subsequent to termi- nation, promptly provide an opportu- nity for an oral hearing to resolve the issue of indebtedness or waiver. Amounts withheld but later deter- • shall be^promptly refunded. (c) Except for debt collection sys- tems in which determinations of in- debtedness or waiver rarely involve Issues of credibility or veracity, or when employment or military status is about to terminate as described in the proviso of paragraph (b) of this sec- tion, prior to collecting any indebted- ness by offset the head of the agency to which the debt allegedly is owed or his designee shall provide the debtor a written demand containing the notices prescribed hi 1102.2 of this part and include therein: •"T Appropriate use should be made of the cooperative efforts of other agencies la effecting collections by offset. Including utilisation of the Army Holdup Ust. and all agencies are enjoined to cooperate in this endeavor. [46VRW113.July31.1981] Agencies shall develop and imple- ment procedures for reporting delin- quent debts to commercial credit bu- 92 FIFBA Oompl±i >/Enfor A-21 Guidance 1983 ------- Appendix Exhibit A-4 Chapter II—Federal Gaiim Collation Standards §102.8 reaus. In the absence of a different rule prescribed by statute, contract, or regulation, a debt is considered delin- quent if not paid by the date due spec- ified hi the provide the credit bureaus with corrections and nota- tions of disagreement by the debtor; and (d) make reasonable efforts to assure that the information to be re- ported is accurate, complete, timely. and relevant. Prior to exercising the option of reporting delinquent debts to commercial credit bureaus, agencies should send a demand letter advising the debtor that such reporting will take place within a specified period of time unless the debtor makes satisfac- tory payment arrangements or demon- strates some basis on which the debt is legitimately disputed. (44 FR 32702. Apr. 17.1979] " • 10tS Contracting for collection atrvleca. Agencies should consider contracting for collection services. Contracts may be entered into for this purpose when they meet the following conditions: (a) The service must supplement. but not replace, the basic collection program of the agency: (b) the author- ity to resolve disputes, compromise claims, terminate collection action. and initiate legal action must be re- tained by the agency and; (c) the con- tractor shall be subject to the Privacy Act of 1974. as amended. 5 U AC 552*. and. when applicable, to Federal and State laws and regulations pertaining to debt collection practices such as the Fair Debt Collection Practices Act. 15 UJ3.C. 1692. (46 FR 22393. Apr. 20.10811 B 102.6 Personal interview with debtor. Agencies will undertake personal in- terviews with their debtors when this is feasible, having regard for the amounts involved and the proximity of agency representatives to such debt- ors. ffti FR 13MI. Oct. IS. 19«6. Redeattmted at 44 FR 22702. Apr. IT. 1979 and 46 FR 22353. Apr. 20.1M1J • 192.7 CMrtact wttfc debtor's employing When a debtor to employed by the Federal Government or is a member of the military establishment or the Coast Guard, and collection by offset cannot be accomplished hi accordance with 5 UJS.C. 5614. the employing agency will be contacted for the pur- pose of arranging with the debtor for payment of the indebtedness by allot- ment or otherwise hi accordance with section 206 of Executive Order 11222 of May 8. 1965. 3 CFR. 1965 Supp.. p. 130 (SO FR 6469). t31 FR 13381. Oct. 18.1966. Redesignated at 44 FR 22702. Apr. 17.1979 and 46 FR 22393. Apr. 20.19811 flt££ Suspension or revocation of ! or eUgibiUtT. II. Agencies seeking the collection of statutory penalties, forfeitures, or debts provided for as an enforcement aid or for compelling compliance will give serious consideration to the sus- pension or revocation of licenses or other privileges for any inexcusable. prolonged or repeated failure of a debtor to pay such a claim and the debtor will be so advised. Any agency making, guaranteeing, insuring, ac- quiring, or participating hi loans will give serious consideration to suspend- ing or dtffqyflinfylpg my tendg*! con- tractor, broker, borrower or other debtor from doing further business with it or *"g»g<"g In programs spon- sored by It If such a debtor fails to pay its debts to the Government within a ible time and the debtor wfll be so advised. The failure of any surety to honor its obligations! in amf"**""*** with 6 U.&C. 11 is to be reported to the Treasury Department at once. No- tification that a surety's certificate of authority to do business with the Fed- eral Government has been revoked or forfeited by the Treasury Department will be forwarded by that Department to all interested agencies. 93 11 artff ------- Appendix Exhibit A-A 5 102.9 131 PR 13381. Oct. 15.1966. Redtsignated at 44 PR 2270Z Apr. 17. 1979 and 46 PR 22353. Apr. 20.19813 910t9 Liquidation of collateral , i*a»ti»to« holding security or coUat- ' -era! which'may be liquidated and the proceeds applied on debts due it through the exercise of a power of sale in the security instrument. or a non-judicial foreclosure should do so * by such procedures if the debtor fails to pay his debt within a reasonable time after demand, unless the cost of disposing of the collateral will be dis- proportionate to its value or special . eluding liquidation of security or col- lateral, is not a prerequisite to requir- ing payment by a surety or insurance concern unless such action is expressly required by statute or contract. [31 PR 13381. Oct. IS. 1966. Redesignated at 44 PR 22702. Apr. 17. 1979 and 46 PR 22383. Apr. 20. 1981] • 102.10 Collection in installments. Claims, with interest in accordance with S 102.10 should be collected in full in one lump sum whenever this is possible. However, if the debtor is fi- unable • to ;jff r_ Jn ;0ne 'Jump -?aumy jastynw be accepted in regular Installments. The size and frequency of such install- ment payments should bear -a reason- able relation to the size of the debt and the debtor's ability to pay. If pos- sible the installment payments should be sufficient in size and frequency to liquidate the Government's claim in more than 3 years. payments of less than $10 per month holding an unsecured claim for admin- istrative fffllfrtion should attempt to obtain an executed confess-judgment note, comparable to the Department of Justice form TJSA-TOa. from a debtor when the total amount of the deferred installments will exceed$750. Such notes may be sought when an " ferred payments, other than a confess- judgment note, may be accepted in ap- propriate cases. An agency may accept installment payments notwithstanding-, the refusal of a debtor to execute a.: eonf ess-judgment note or to give other • security, at the agency's option. Bl PR 1338U Oct. 18. 1966. Redesifnated u 44 PR 22702. Apr. 17. 1979 and 46 PR 22353 Apr. 28. 19811 -.Xii • 162J1 Exploration of compromise. / Agencies wQl attempt to effect com- promises (preferably during the course of personal Interviews), of claims of $20.000 or less exclusive of interest, in accordance with the standards set forth tn Part 103 of this chapter in all -in .which. i£ can be ascertained not permit payment of the claim in full, or in which the lltigative risks or the costs of litigation dictate such action; C31 PR 13381. Oct. 15. 1966. Redesignated at 44 PR 23702. Apr. 17. 1979 and 46 PR 22353. Apr. 20. 19811 • 102J2 Interest In the absence of a different rule prescribed by statute, contract, or reg- ulation. interest should be charged on delinquent debts and debts being paid in installments in conformity with the Xreasnry v-Vtacal 'Requirements VManuaL W«mtm-debtisT«id in mstan- ments. the Installment payments will first be applied to the payment of ac- crued interest and then to principal, in accordance with the so-called "U.S. Rule." unless a different rule is pre- scribed by statute, contract, or regula- tion. Prejudgment interest should not be demanded or collected on civfl pen- alty and forfeiture claims unless the *1* ••'toH ,fch» rtmlm 'f rjff« h inter- est. Bee Rodgers v. United States. 332 U.S.37L ignated at 144 PR 29702. Apr. 17. 1979. R 46 PR 82353. Apr. 20. 1881] • 102:13 Analysis of coats. Agency collection procedures should provide for periodic comparison of covery rates for debts of different types and in various dollar ranges should be used to compare the cost ef- 94 FIFRA Co«pliance/Enforces*ent A-23 Guidance Manual 1983 ------- Appendix Exhibit A-4 Chapter It—Federal doiim Collection Standards fectlveness of alternative collection techniques, establish guidelines with respect to the points at which costs of further collection efforts are likely to exceed recoveries, assist in evaluating offers in compromise, and establish pjirHrmim debt amounts below which collection efforts need not be taken. Cost and recovery data should also be useful in Justifying adequate resources for an effective collection program. (44 PR 22702. Apr. IT. 1979. Redeslavated at 46 FR 32353. Apr. 20.1981] B 112.14 Documentation of atfmfaUitrati*e eoUectio* action. All administrative collection action should be documented and the bases for compromise, or for termination or suspension of collection action, should be set out in detail Such documenta- tion should be retained in the appro- priate claims file. (31 FR 13381. Oct. IS. 1966. Redesicnated at 44 FR 22702. Apr. 17.1979 and 46 FR 22353. Apr. 20.19811 9102.15 Automation. Agencies should automate their debt collection operations to the extent it is cost effective and feasible.. (44 FR 22702, Apr. 17.1979. Redesii 46 FR 22353. Apr. 20.1981] »ted at 6102.16 Prevention of overpayments, de- linquencies, and default*. Agencies should establish procedures to Identify the causes of overpay- ments, delinquencies, and defaults and the corrective actions needed. One action that should be considered is the reporting of debts or loans, when first established, to commercial credit bu- reaus. C44 FR 22700. Apr. 17.1879. Redeslgnated at 46 FR 22353, Apr. 20.1981] 1102.17 Additional adminiatrative eoUee- tton action. Nothing contained in this chapter is intended to preclude the utilization of any other administrative remedy which may be available. (31 FR 13381. Oct. 15.1966. Redeslgnated at 44 FR 22702. Apr. 17.1979 and 46 FR 22353, Apr. 20.1981] PART 103—STANDARDS FOR THE COMPROMISf OF CLAIMS Sac. 103.1 Scope and application. 10X2 Inability to pay. 103J Utiaatlve probabilities. 103.4 Cost of collecUnc claim. 103 J Enforcement policy. Itt.6 Joint and aeveral liability. iaj.7 Settlement for a eomblnaUon of 103.8 Further review of compromiae offers. 10L9 Restrictions 3. 80 Mat. 309: 31 UAC. 952, 31 FR 13382. Oct. IS. 1966. unlen otherwife noted. flt3.1 Sceteaadappl The standards set forth in this part apply to the compromise of claims. pursuant to section 3(b) of the Federal Claims Collection Act of 1966. 80 Stat 309. which do not exceed$20.000 ex- clusive of interest, The head of an agency or his deslgnee may exercise such compromise authority with re- spect to claims for money or property arising out of the activities of his agency prior to the referral of such claims to the General Accounting Office or to the Department of Justice for litigation. The Comptroller Gener- al or his designee may exercise such compromise authority with respect to claims referred to the General Ac- counting Office prior to their further referral for litigation. Only the Comp- troller General or his deslgnee may effect the compromise of a claim that arises out of an exception made by the General Accounting Office in the ac- count of an accountable officer, in- cluding a claim against the payee. prior to its referral by that Office for litigation. I1BL2 Inability to pay. A claim may be compromised pursu- ant to this part If the Government cannot collect the fuD amount because of (a) the debtor's inability to pay the full amount within a reasonable time. or (b) the refusal of the debtor to pay the claim in full and the 'Govern- ment's inability to enforce collection in full within a reasonable time by en- forced collection proceedings. In deter- 95 -f arx-p/Rn-fr>rr<*»*MH' A-24 Guidance Manual 1983 ------- Appendix Exhibit A-4 .,\ §10X3 mining the debtor's inability to pay the following factors, among others, may be considered: Age and health of the .debtor; pres- ent and potential income; inheritance prospects; the possibility that assets have been concealed or improperly transferred by the debtor the avail- ability of assets or income which may be realised upon by enforced collection piwanrflpgn The agency wfll give con- sideration to the applicable exemp- tions available to the debtor under State and Federal law in determining the Government's ability to enforce Uncertainty:** to the price vhteh ooDaCeral Brother property v bring at forced sale may properly be considered in determining the Govern- ment's ability to enforce collection. A compromise effected under this sec- tion should be for an amount which bears a reasonable relation to the amount which can be recovered by en- forced collection procedures, having regard for the exemptions available to the debtor and the time which collec- tion will take. Compromises payable in installments are to be discouraged. However, if payment of a compromise by installments is necessary, an agree- thereon and acceleration* of the bal- ance due upon default in the payment of any installment should be obtained, together with security in the manner set forth in i 102.8 of this chapter, in every case in which this is possible. If the agency's files do not contain rea- sonably up-to-date credit information as a basis for assessing a compromise proposal such Information may be ob- penalty of perjury showing the debt- or's assets and liabilities, income and expense. Forms such as Department of Justice form DJ-35 may be used for this purpose, similar data may be ob- tained from corporate debtors by resort to balance sheets and such addi- tional data as seems required. A claim may be compromised pursu- ant to this part if there is a real doubt concerning the Government's ability to prove Its case in court for the full THto 4-Accoyntr .*"••* amount claimed either because of the legal issues involved or a bona fide -pute as to the facts. The amount ac- . cepted in compromise in such- cases- should fairly reflect the probability of prevailing on the legal question in- volved. the probabilities with respect to full or partial recovery of a judg- ment having due regard to the avail- ability of witnesses and other eviden- tiary support for the Government claim, and related pragmatic consider- ations. Proportionate weight should be given to the probable amount of court costs which may be assessed against the Government If* is unsuccessful in litigation, baring regard for the litlga- tive risks involved. Cf. 28 U.S.C. 2412. as amended by Pub. L. 89-507, 80 Stat 308. »1«&4 Cost of collecting claim. A claim may be compromised pursu- ant to this part if the cost of collecting the claim does not justify the enforced collection of the full amount The amount accepted in compromise in such eases may reflect an appropriate discount for the administrative and 11- tigative costs of collection having regard for the time which it will take - to :etteet caUectlnn. Caat of eoileetmg -way tee^^snnstantha factor to-ttoe set- tlement of small claims. The cost of collecting claims normally wfll not carry great weight in the settlement of large • 10X5 Enforcement policy. Statutory penalties, forfeitures, or debts established as an aid to enforce- ment and to compel compliance may .in terms of deterrence and securing com- pliance. both present and future, wfll be adequately served by acceptance of the sum to be agreed upon. Mere acci- dental or technical violations may be dealt with less severely than willful and substantial violations. e lotat- ly and severally liable collection action wfll not be withheld against one such debtor until the other or others pay their proportionate share. The agency 96 FHFRA. Compliance /Enforcement- ------- Appendix Exhibit A-4 Choptw II—Federal Claims CoOactfafi Standard* f 100 'should not attempt to allocate the burden of paying such claims u be- tween the debtors but should proceed to liquidate the indebtedness as quick- ly as possible. Can should be taken that compromise with one such debtor docs not release the agency's daim against the remaining debtors. The amount of a compromise with one such debtor shall not be considered a precedent or as morally binding in de- termining the amount which win be required from other debtors jointly and severally liable on the claim. 9103.7 SctUeowfit for a ibbutio* of A claim may be compromised for one or for more than one of the reasons authorized in this part. 9103.8 Further review of cosBS-ranisc often. If an agency holds a debtor's firm written offer of compromise which is substantial in amount and the agency is uncertain as to whether the offer should be accepted, it may refer the offer, the supporting data, and par- ticulars concerning the- claim to the General Accounting Office or to the Department of Justice. The General Accounting Office or the Department of Justice may act upon such an offer or return it to the agency with instruc- tions or advice. I10&9 Restrictions. Neither a percentage of a debtor's profits nor stock in a debtor corpora- tion will be accepted in compromise of a claim. In negotiating a compromise with a business concern consideration should be^given to requiring a waiver of the tax-loss-carry-forward and tax- loss-carry-back rights of the debtor. PART 104—STANDARDS FOR SUS- PENDING OR TERMINATING COL- LECTION ACTION See. 104.1 Scope and application. 104.2 Suspension of collection activity. 104 J Termination of collection activity. 104.4 Transfer of claims. AuTHomrrr See. 3. 80 Stat. 309: 31 ttS.C. 992. Sooacr 31 FR 13383. Oct. IS. 1988. unless otherwise noted. §184.1 appHeathm. The standards set forth in this part apply to the suspension or termination of collection action pursuant to sec- tion Kb) of the Federal Claims Collec- tion Act of i960. 80 Stat. 309. on claims which do not exceed $20.000 ex- clusive of interest. The head of an agency or his designee may suspend or terminate foOt^far action under part with respect to claims for money rty arising out of activities of his agency prior to the referral of such fi^i^n* to th* General Accounting Office or to the Department of Justice for litigation. The Comptroller Gener- al or his designee may exercise such authority with respect to claims re- ferred to the General Accounting Office prior to their further referral for litigation. 9184.2 *8wft niton of ceflcctk etivtty. Collection action may be suspended temporarily on a claim when the debtor cannot be located after diligent effort and there is reason to believe that future collection action may be sufficiently productive to Justify peri- odic review and action on the claim having consideration' for its sbse and the amount which may be realized thereon. The following sources may be of assistance in I'Mftlfig m fterfng debt- ors: Telephone directories: city direc- tories; postmasters; drivers' license rec- ords; automobile title, and license rec- ords; state and local governmental agencies; district directors of TntmuU Revenue; other Federal agencies; em- ployers, relatives, friends; credit agency skip locatf reports y** credit bureaus. Suspension as to a particular debtor should not defer the early liq- uidation of security for the debt. Every reasonable effort should be made to locate missing debtors suffi- ciently in advance of the bar of the ap- plicable statute of limitations, such as Pub, I*. 89-805. 80 Stat. 904. to permit the timely filing of suit if such action is warranted. If the mining debtor has signed a confess-judgment note and is in default, referral of the note for the entry of judgment should not be de- layed because of his missing status. 97 FIFRA Co»pliance/Enforcea*ent A-26 ance 1983 ------- Appendix Exhibit A-4 51043 Collection action may be suspended temporarily on a claim when the debtor owns no ffv^fftflntlnl equity in realty and is unable to make payments on the Government's claim or effect a compromise i thereof > at the time but his future prospects Justify retentions of the claim for periodic review and '.*ss (a) The applicable statute of limita- tions has been tolled or started run- ning anew or (b) future collection can be effected by offset notwithstanding the statute of limitations. (31 PR 13381. Oct. 15. 196«. aa amended at The head of an agency or his desig- nee may terminate collection activity and consider the agency's file on the claim closed under the following standards: (a) Inability to collect any tudttan- tial amount Collection action may be terminated on a claim when it be- comes clear that the Government cannot collect or enforce collection of any significant sum from the debtor having due regard for the Judicial rem- edies available to the Government, the debtor's future financial- prospects. i the . • When an agency has doubt as to -.whether collection .action should be • ..^MJia«»«iaH jpr. t»t itttrtm+m* qp a. CJSiPj it may refer the claim to the General Ac- counting Office for advice. When a sig- nificant enforcement policy Is involved in reducing a statutory penalty or for- feiture to Judgment, or recovery of a Judgment is a prerequisite to the im- position of administrative sanctions. such as the suspension or revocation of a license or the privilege of partici- pating in a Government sponsored program, an agency may refer such a claim for litigation even though termi- nation of collection activity might oth- erwise be given consideration under .1.104.3 UO JOT icX^CTitmvan wnich an ment -or otherwise wHl be referred to the Department of Justice for further action if renewal of the Judgment lien or enforced collection proceedings are Justified under the criteria discussed in this part, unless the agency con- cerned has statutory authority for >i^nrfnny its own litigation. PART 105—REFBUAIS TO GAO OR 109.1 Prompt referral. 108.2 Current address of debtor. 10S.3 Credit data. 105.4 Report of prior collection action*. 105.8 Preservation of evidence. 109.6 Minimum amount of referrals to the Department of Justice. aao. li«» Btat *«* <*! TTB.C. 952. BOOTTCE 31 PR 13384. Oct. IS. 1966. unless otherwise noted. 98 FIFRA /Bnf orcr m1 ut A-27 Guidance 1983 ------- Appendix Exhibit A-4 Chapter II—Federtri Claim* Coltetfaa Standards$105.6 9 1*8.1 Prompt referral on which collection Action been taken in accordance with Part 102 of this chapter and which cannot be compromised, or on which collection action cannot be suspended or terminated, in accordance with Parts 103 and 104 of this chapter, wfll be referred to the General Accounting Office in •accordance with R& 236. as amended. 31 U-S.C, 71. or to the De- partment of Justice, if the agency con- cerned has been granted aa exception from referrals to the General Account- ing Office. Such referrals should be made as early as possible consistent with aggressive agency collection action and the observance of the regu- lations contained in **<<« chapter and in any event well within the time lim- ited for bringing a timely suit against the debtor. §10&2 Current address of debtor. Referrals to the General Accounting Office, and to the Department of Jus- tice for litigation, will be accompanied by the current address of the debtor or the name and address of the agent for a corporation upon whom service may be made. Reasonable and appro- priate steps wfll be taken to locate missing parties in all cases. Referrals to the General Accounting Office, and referrals to the Department of Justice for the institution of foreclosure or other proceedings, in which the cur- rent address of any party is unknown will be accompanied by a listing of the prior known addresses of such a party and a statement of the steps taken to locate him. HtftJ Credit data. •JCn. (a) Claims referred to the General Accounting Office, and to the Depart- ment of Justice for litigation, will be n^T*ompf p1*i* by reasonably current credit data indicating that there is a reasonable prospect of effecting en- forced collections from the debtor. having due regard for the exemptions available to the debtor under State and Federal law and the Judicial reme- dies available to the Government. (b) Such credit data may take the form of: (1) A commercial credit report. (2) an agency investigative report showing the debtor's assets and liabilities and his income and ex- penses. (3) the individual debtor's own ftfif fi**1fil tt***i"fflt executed under penalty of perjury reflecting his assets and liabilities and his income and ex- penses, or (4) an audited balance sheet of a corporate debtor. Such credit data may be omitted ifc (1) A surety bond to available in an amount sufficient to satisfy the dalm in fun. (2) the forced sale value of the security available for application to flitvmn \vn»nj'f rtmtm Jg fUffJCJPnt to satisfy its dalm in fun. (3) the re- ferring agency wishes to liquidate lorn collateral through Judicial foreclosure but does not desire a deficiency Judg- ment. (4) the debtor to in bankruptcy or receivership, or (8) the debtor's lia- bility to the Government to fully cov- ered by insurance, in which case the agency wfll furnish such information a* it can develop concerning the Iden- tity and address of the insurer and the type and amount of insurance cover- age. § 108.4 Resort of prior collection actions. A checklist or brief summary of the actions previously taken to collect or compromise a claim wfll be forwarded with the claim upon its referral to the General Accounting Office or to the Department of Justice. If any of the administrative collection actions enu- merated in Part 102 of this chapter have been omitted, the reason for then- omission wfll be given with the referral. The General Accounting Office and the Department of Justice may return or retain claims at their option when there to insufficient Justi- fication for **** omission of vnf or more of the ^<*TT**T1<*trattvf collection actions enumerated in Fart 102 of this chapter. llt&S Care wfll be taken to preserve aU files, records and exhibits on claims re- ferred or to be referred to the General Accounting Office, or to the Depart- ment of Justice for litigation. fl 105.* Minimum amount of referrals to the Department of Justice. Agencies will not refer claims of less than $600. exclusive of interest for liti- 99 FIFBA Govpllance/Enforcenent A-28 Guidance Manual 1983 ------- Appendix Exhibit A-4 5105.7 1W» Cation unless: (a) Referral is impor- 1106.7 Referral* to GAO. tant to a significant enforcement • p,r..- _i, „» .1-1—. »-, policy or the debtor harnot only the clear ability to pay thedaim but the •Government -can elfecnv«iy ea- under State or Federal Law and the judicial remedies available to the Gov. eminent £43 FR 38891. Aus. 1.19773 100 FIFKA Gbapliance/EnforceiKnt A-29 Guidance Manual 1983 ------- Appendix Exhibit A-5 Model Demand for Payment Letter Name: Date: Address: I.F.&R. No.: Demand for Payment of Civil Penalty - Warning For Failure to Pay Dear Sir/Madam: In connection with the enforcement of the Federal Insecticide, Fungicide, and Bodenticide Act, as amended (7 U.S.C. J136 et seq.), you are hereby given notice that your penalty payment of$ ______^^_ is due within thirty (30) days and that we expect payment in full before the expiration of the sixty (60) day payment period that started on and ends on If payment is not received by the expiration of the payment period, this matter shall be referred to the (United States Attorneys Office/Department of Justice) which shall recover such amount by civil action in the nature of a debt owed to the United States government. In the event that you have already submitted your payment or that it is currently in transit, please disregard this notice and accept our apologies for any inconvenience it may cause you. Title EPA Region Date At FIFRA Compliance/Enforcement A-30 f^ridi'w* Manual 1983 ------- Appendix adhibit A-6 Model Final Demand for Payment Letter Name: Address: I.F.&R. No.: Date: Final Demand ^or -Payment of Civil Penalty - Notice of Referral to the U.S. Attorney Dear Sir/Madam: This letter is to Inform you that your penalty payment of $_______ is past due and to demand immediate payment of the above-mentioned sum. The penalty was Imposed by a (Final Order, Consent Decree, or Default Order) signed by ±ne Regional Administrator of "Region on (date) . You were notified of your obligation to pay upon receipt of the Regional Administrator's order on and you were again informed of your obligation to pay on (date second demand was sent) « Tou are hereby notified that unless the payment of the penalty is received in the Regional Office within fifteen (15) days of the date of this notice, this matter will be referred to a U.S. Attorney who shall recover such amount in a civil action in the appropriate United States district court. Such action is routinely accomplished through a motion for summary judgment in favor of £be United £ta£es. In, this proceeding, yon^vill be barred from y -Ln&tm of fact or i«f Ixa sthst «b»uld fc*ve 4>een raised in the administrative proceeding. Title IPA Jtegion . •** ** Date At FIFBA OoapH ance/Knforcement A-31 Guidance 1983 ------- Appendix Exhibit A-7 CLalns Collection Litigation Report An Overview The Federal Claims Collection Standards (4 C.F.R.$$101-105) prescribe regulations for the administrative collection, compro- mise and termination of agency claims, and for the referral of administratively uncollectible claims to the General Accounting Office or to the Department of Justice for litigation. The Standards -require that certain information" be provided to the Department of Justice when an agency refers a claim for litigation and enforced collection (4 C.F.R.$105.1 et seq.). In cooperation with the General Accounting Office, tKe" attached Claims Collection Litigation Report (CCLR) has been developed by the Debt Collection Section of the Executive Office for Onited States Attorneys, Department of Justice, as the standard report to provide this information when claims are referred to Justice for litigation and enforced collection. All claims referred to Justice should be accompanied by a completed report. The CCLR is provided in three different formats: letter (Exhibit 1), memorandum (Exhibit 2), and standard form (Exhibit 3). Each agency may choose the format it prefers to use. Dupli- cate copies of each format which include bracketed explanatory text are also provided (Exhibits 4, 5 and 6).* In addition, an Item Explanation (Exhibit 7) is provided to assist and direct agencies on the specific information required in each item on the report. Uniform use of -the CCLR by all agencies will serve a number of purposes. First, it will provide Justice with all the information it must have to effectively litigate the claim and enforce collection. The CCLR will provide this essential information "on top -and up front" so that no time will be lost searching the client agency's file for the necessary informa- tion. This will increase the speed at which claims received from agencies are taken to judgment, or otherwise converted to paying status, and, as a result, should increase the amount of money collected by Justice and returned to the agencies. Second, the CCLR should improve the quality of claim referrals to Justice by prompting agencies to take more aggres- sive administrative- action to collect claims. Such aggressive collection action is required by the Federal Standards (4 C.F.R. iioart^et seg.) but has often been overlooked or ignored. Zn this respect, the CCLR will also serve as a checklist and as a reminder to all persons who deal with these matters of the importance of the Federal requirements. Furthermore, both aggressive action by the agency to collect and prompt referral to Justice of claims which are accompanied by current, accurate •and complete information, directly affect Justice's success in the enforced collection of claims. Therefore, we hope that each agency will establish the goal that all of its referrable claims be referred to Justice not later than six months after * The Pesticides and Toxic Substances Offices have adopted the memorandum format. Therefore, Exhibit 5 (&e memorandum format that includes bracketed explanatory text) is included in this appendix. Exhibits 1, 2, and 3 (blank forms) and Exhibits 4 and six, which pertain to other formats, are not included. FIFRA CoBpllance/Enfor A-32 Guidance .Uteniui 1 10ft? ------- Appendix Exhibit A-7 the agency's final determination of the amount of the claim. It, am stated in the Item Explanation, preparation of the CCLR is1 «ade an integral and contemporaneous function of aggressive collection efforts by all agencies, the CCLR will be completed as and when the agency completes administrative collection action, thus, allowing agencies to promptly, refer claims to Justice. Finally, the CCLR will provide the information needed by Justice from all agencies in the same order and sequence. This will enable Justice personnel to design procedures around the report which will permit better utilisation of the modern word and data processing equipment which many law offices now have. Once .the information is received in the same sequence, then prerecorded programs will enable such equipment to "read" each •debtor file" to "automatically* produce the documents essential to litigation, for example, the demand letter, complaint, summons and judgment, which relate to a claim. Such automated collec- tion* ^yatmms «ill improve.the mtficleney and speed with which ciaimsmre handled aad«',------- Appendix Exhibit A-7 itemization of the dates and amounts of any payments made by the debtor to the agency or any credits made by the agency to the debtor, and an itemization of the amount due and owing) and which may be offered by the United States Attorney into evidence to prove the claim; 2) A Department of Justice Demand Letter (Exhibit 8) which will be used by the Onited States Attorney to notify the debtor that the Department of Justice has received the claim for litigation and suit will be brought unless full payment is made within 10 days (please note that this letter need only be prepared and included in the CCUt package for those Onited States Attorneys' offices listed on the Attachment to Exhibit 8); 3) A Department of Justice Acknowledgment ('Comeback Letter") (Exhibit 9) which will be used by the Onited States Attorney to officially notify the agency that the claim which was referred has been received and will give the referring agency the Onited States Attorney's claim number) and 4) A Department of Justice Deficiency-or Declination Letter ("Sendback Letter*) (Exhibit 10) which will be used by the Onited States Attorney to send deficient claims, or claims which the Onited States Attorney declines to litigate, back to the agency. The letters should be prepared in the same format reflected in the exhibits. The Department, of Justice solicited comments on the use, con- tent and format of the report from divers Federal agencies. These comments expressed 'almost universal support for the concept of the report. To the extent possible, all agency suggestions for changes to the report, or that additional items be included in the report, were incorporated. Several agencies were concerned that some of the items of information requested on the report may be superfluous to their particular claims or impossible to obtain. Inability to obtain all information required by the report should not be viewed as a bar to referral of claims to Justice. However, information requested in the litigation report should be provided to the extent feasible. Questions of feasibility should be answered on the basis of and with a clear understanding of the fact that claims referred to Jtfrtice are for litigation following aggressive administrative collection action oy the referring agency, and that on the basis of the information contained in the CCLR, Including ThYTgency's determination ot the deDtor¥s~"abTTT'ty to pay* and the accompanying supporting documentation or agency debtor file. Justice should be able to successfully prosecute the claims referred to it to judgment and enforce collection of £ substantial sum. Any omissions should be explained in the appropriate item on the face of the report. -3- FIF1A Compliance/Enforcement A-34 ------- Appendix _____ Exhibit A-7 We realize that M agencies gain experience using the CCLR, problems may arise which could not be foreseen while the report was being developed. Although completion of the report is required, its content and format may be modified in the future baaed upon any commits or suggestions from agencies using the report. Comments should be brought to the attention of Mr. Edward B. Puna ton, .Assistant-. Director, Debt Collection Section,; Executive Office, for 0. S. Attorneys, Suite 803, 5205 Leesburg Pike, rails Church, Virginia 22041. In the near future, the General Accounting Office will incorporate the CCLR and accompanying materials in Title 4 of the General Accounting Office Policy and Procedures Manual for the Guidance of Federal Agencies. -4- FIFRA Goapliance/Eoforceaent A-35 Guidance *a«"^l 1983 ------- Appendix Exhibit A-7 >*< CLAIMS COLLECTION LITIOATION (OB MBDTMM of rvfwrlng «go»cy) XDrMI Tot XWItW» STvtSS XJudicial District) of ISt*t. u tlw lotil limrwt *•. !• tto torvl Mlalrfrotlva I Is tfta total poMlty Xtatcl !• ttw tvtvl mem li *» •MM*) lirt«r«t l« t*« JOt «•*». TkU elala I* r«fvr« 1e yo« fer suit «M Mdi otMr •etloi a yai ««• ^pro»rl«t» to wfarei CDllaetlan. HM prior action IMM by ml* agowy Md tta lnforwtlo* «ro»l«od yon o pil« fully «ritt> r«MT»l Cl«l« ColloetloH StanMr4« (4 Cflt tarts 101-109). n» tttmmftmttm til 4 CM ftrts l«-4fB !• sttMsari *M th» Inforwrioii you ••«• isausatx fol low. I. Os*» of UPHII 2. Social Saearlty 3. Als* ILIst o> iat«/«p»lleatlait of oseter. If t*aa» actual slaes of raaldsaea. not varlflad 7. »H wrlflad ky/Mioai Tl t. Ostrtar lusoM UMstrwls«]) I8>o» l»f------- Appendix Exhibit A-7 >t< / % 11. Stifuta of llaltatleaa (SOI) rum on: (Data?] (12. ccat'd.) 13. tlrtt oaaaa* tar aaMant aaa» ant lOatatl 15. Mrrtio* of f lr«t danaf*: IC.Q.. toftar. ••! lor «TI 17. U»t Maaad aada byt J*iO|Jjakagant. official, off teat) • J», ™0a*«or;.» raaacaaaj . • .- .. • Sjjgg^jg^jgLilMJSlSlLSBSSlLm— • - (20. eant'dt> to tt» clala. If know. 1 21. Haapanaa, If aay, to dabtor's dlspvta* 1 /tenner rdabonaa to daMer*! dl>out«.l j22Leent'«.) »««l(*bU to «Mter. HOB «• • Itti r«a«rd tlMrcto. If «iv.l 23. CoBproBlw of f«r«* w «l leltM: HOaotattl <24. conr'a.) Tt» tfabtor or effarad tt» « macro* !«• offer 9l««n: If w. vtat MS 23. RaaaonsB by loancy or 4atof)ofs aaauirr r«eo»»r«dT 61 «• orfwr r»(«v«nt of (Orr» of datmiliwtloii.l 30. Tbtil (MMMr/aMMit of pafBMts • • -- -..mj&m KI CM 32. AaDunf appllod to elMroai anasMd* pMBltlo* «M latarwti S •MMltlot «d aceruM Intararri S n* rrnt'd.l iiatttir ara IB ta MODI ltd. 1 ' ' 36. OaotorU last payaant; SlAaount and dataTI C >T< tt< 12, BMU for SOL datat (£,2lj oafault drfa. lait pa»aanf datal 14. plr»t «aaaad aada byi (Mho, t,«v aaiairr. official^ offleaT) f«W &4W^ ^••xid for pfltyMWf »ba) OHI lOataTI It. Mttiod of laat aaaandt |E.a.. lattar. otana. ooraonal eantarTTI ,20. >aaa»- aittur 4J a»ta «l«<«i 22. Bdwwtlon of ad*lal«lratl«* roaadla*: {Daaerlba adalnlstratlva raaadloi 6tw Ma advlaad of UMB. and oabtor** aerlon 24. taala for eoavoBlMi {•at • eeaoraalia offor alleltad fro* •totor by tHa claimant aoonevT Wat • basis for Tfia beslstl 2ft. Othvs logally rasaoislbla for dabt: I£^Q, . banaf Iclarl-n CdHlir'i itors. 1 I'M 'Ttwmty Whir «r -MMrarT (kcMon, • fm | ffltfty not 7 1 f vaM *mt scT Ion And wtut tillm.l i fOHOION 29. Original principal oMd by dabtor: SIAaaunfTI 31. AaaaiT apfllad to arlncipali • * 33. Balanca dua oa principal: t 33. faplaln application of aaMantu (b^laln ho* aivawits roealMd froa tt» 37. lotvast accrual tfatai fTl»a data from •ftlctt Intaroit Is dua.i -2- Haao) . 4 A-37 Guin «I 1983 ------- Appendix Exhibit A-7 tl ry« City. St»t« am ZIP Coa«M UlY [faiilriyar't OOP* m«O«rtl n«Ttl 41. Mary *vifi«> T| llaoloor'i anoo« «Mirrr 10 mr lEnlaln. I __^ 49. Tto teMocl a»«crlb» «nd loi »IH M*I*T y«« In looting lootleo of In Mlett Tta U»ltM St*«M In •ftloi v«lu> a» ar 47. It or Mid In uammut, tta fair avMrr Enelaln M«l« «ar f»lr •»•»»» or ««MT V«IM o» nil* el*la wault Mi loa alvxi. If any.; _ Mtk *• raojr* rM»an«ll« lltmtil •• aBlllty « pay. M •tfliw* by !• coMroilM offer by TM >»tj MU!« k»i 6«Dl«ln In raHflomBlo IMnntlm offlcirt •M»». tlTU. «o»«ey. ••Ulna £3. m>tliia/«l«BW»l«s off lor /••Mr: 91. 'S^afM flaproprlof loii -J- FIFRA Gcmpliance/Eoforceaent A-38 uiane 1983 ------- Appendix Exhibit A-7 It I con bo of o»y fyrThor oulftoneo in ml* •error, »100*0 do not hooltrro to coll oo •t to* ivokor glvo* okcv*. > tor «*M*lt*g .too.CUtat >rritui >irn Th» ij»nli. Tt» brockets, tn* •*•«. or ft* tvrt >ltkla *ltMr of tt» l«nw .III not miMT a* «• flMl tf»M or prlm*d report, but tmn kMn l»clu*M koro to •xpldn or clarify «• ojMtloac/lf«&. Tho mryln «M tM •ttlnes cro HMIcato* ea fho flrct MM. »e» wr. tt»y MM not k» eMngM «• a*l«t» t*» wrlr* roporr. Dili mart •It* «rrt»ni l*«»r*) t»«t om irut. Tko QMroji en too flror p»go U txo •Inilo* ottrou* Mr toj o oMroM.*! Ibo JuOlelw tlitrlcr aoy bo «-irro« or -Olttrlcr of Konooo,* oo opprorl«r». HM Sroto OM bo too lartor oBbrovloripn. ^^^_ Olopo or •ouTtld* Olttrler of ta •ceooroo: 1*0 c*»lt«i FIFRA Oovpllance/Baforceaent A-39 1983 ------- Appendix Exhibit A-7 OCTAILB. If mn tfuet it fclxl ma» 5. FXFRA Goapllance/Eoforceaent A-40 Guidance Manual 1983. ------- Appendix Exhibit A-7 GADS Itaa ani ion CUiaa ttOKetion TJf Igatlm (OCLB) provtda t&a CUiw CeAlactilbn stana«na«JT"C.y.iU iSlOl-TQg) ia^™1^1K-x^™ W claia . iadiatiag ttue Ability to Ifcy* OB a oultipl* oC £Msibillty en tat boil of «d witt a elMT iBteBStaoding of tot fact tnat cLii«« xaftoad to ion contain*! in tna tlon of a aueitaBtial ataouldb> abla to £ ^a^hfl *** l^a^B 1 potot a«g«ly ppogida a ggning liat of only tba aBMBMl ^•bAf»;4^Ht •Amltft M^aVt P^tt t^B^a4 P*tf M^k aw^aVMW AM 4*^ ttaa aiaiiai'i in ttaa nmin? liat. ttan a xopniaf liit ia previdad in FIFRA Goopliance/EoforceMnt A-41 ------- Appendix Exhibit A-7 lieu of inserting tfce answer* onto the actual report form, however, great car* should be taken by tht agency to assure that tht Item numbers and answers pro- vidad in the running list imtesujuJ to the Item numbers on the report. This method of providing information should both sinplify and expedite the agency's preparation of the OCLR. In addition, it should allow for better utilization of available word and data processing equipment to prepare the report. M both the OCLR and the following explanations state, all documentation which supports the claim or, where appropriate, the agency's debtor file should be attached to the report. In addition, the following materials should be red and included in the OCLR 1) A Certificate of Indebtedness which will provide the United States Attorney with a complete statement of how the claim aroee (including the statutory, regulatory, or other authority from which the claim arose, a summary statement or resume of the factual basis for the claim, an itemization of the dates and amounts of any payments nude by the debtor to the agency or any credits made by the agency to the debtor, and an itemization of the amount due and owing) and which may be offered by the United States Attorney into evidence to prove the claimj 2) A Oepattaenl of Justice Demand better (Exhibit 8) which will be used by the United States Attorney to notify the debtor that the Department of Justice has received the claim for litigation and suit will be brought unless full payment is aade within 10 days (please note that this letter need only be prepared and included in the OCLR package for those United States Attorneys' offices listed on the Attachment to Exhibit 8); 3) A Depenaenl of Justice Acknowledgment (•Comeback Letter") (Exhibit 9) which win be used by the United States Attorney to officially notify the agency that the claim which was referred has been received and give the referring agency the United states Attorney's claim number} and 4) A Dnau.lme»L of Justice Deficiency or Declination Letter (Exhibit 10) which will be used by the United States Attorney to send defi- cient claims, or claims which the United states Attorney declines to litigate, back to the agency. letters should be prepared in the same format reflected in the exhibits. TOP FOHTXCN ,*H Date: Show the date that the OCLR is signed. Inside Address Slnply show "United States Attorney," the or To" Block: Federal judicial district, and the city, state and zip code. The judicial district may be written, "Southern District of Iowa," or "District of Kansas," a* appropriate. The state can be the accepted two -2- FXFBA flnggpi < anff*/Hnf<>T^^aent A-42 t±rtjpnff Manual 1983 ------- Appendix Exhibit A-7 letter abbreviation. A complete nailing address far the united States Attorney should be provided on the nailing envelope. (Exhibit 11 provides cm-rent nailing oar united States Attorneys.) "near Block: Debtor's Pull Nan: Debtor's Nailing Address: Debtor's File or Reference Nunber: Total Principal Due: (When using the "NenorandutT or "Poem* for- ,nat] Show .the nane, title, complete nailing address and PIS telephone nunber of the agency official who will sign the report. Show the last, first and full niddle name or niddle initial of the debtor. Itoere appropriate, indicate whether ttelitu is a "ST.," -Jr.," "II," etc. Show the complete nailing address for the debtor which has been verified by the agency «ithin-the past six nonths. Show the agency's debtor file or reference ntBfeer. Show the anount of principal due on the fflatp*! itfisre fees and COBUI advanced are to be recovered fr^tn tne debtor, include then in the principal. The Certification of Indebtedness which you attach should include an explanation and itenizaticn when the total principal due is a cumulative total and combines separate items (e.g., recover- able sees and o >stB advanced, promissory notes of different dates or amounts). Ttotal Interest Due: total Administrative rOharges Show the total ancmnt of .interest due of: Indebtedness. '• Bte OKI Lif icat ion of Indebtedness which you attach should include an itenization and explanation of interest charges and when, for example, the total interest due includes separate items such as interest due en more than one promissory note or a aeries of discrete claims, each interest charge should be itemized and explained. Show the total anount, through the date of tne Certification of Indebtedness, of any by the agency to cow the costs of processing and handling the claim pursuant to the Debt Collection Act of 1982, P.L. 97-365, $11(e)(2). Ihe Certification of Indebtedness which you attach should include an itaniza- tion and explanation of such charges. -3- FIFRA Ckmpliance/Bof or A-43 Gui 1983 ------- Appendix Exhibit A-7 Tbtal Penalty Charges Due: Total Mount Duet Annual XntctMt Ratet SOL (Statute of Uaitations) Dstet ITEM it Show th* total amount, through the date of the Certification of Indebtedness, of any penalty charges which nay nave been assessed by the agency Ear debtor's failure to pay any portion of a debt more than ninety (90) days peat due pursuant to the Debt Collection M* of 1962, P.L. 97-365$11(e)(2). The Certification of Indebtedness which you attach should include an itamization and explanation of such penalty charges. it due the Snow the total (Grand total) en the data through the date of Certification of Indebtedness. ITEM 2: ITEM 3t Show the rate of annual interest charged by the agency on the debt. Show the saee statute of limitations date which is to be entered at Item 11 of the COR. THE LEtfJUK Show the debtor's date of birth. In the case of a non-beneficiary debtor (e.g., a representative payee) and the date~otoirth of the debtor is unknown, show "unknown." In the event that the debtor is a corpora- tion or partnership, show "Not applicable [corporate/partnership] debtor." Show the debtor's social security nunber. In the case of a non-beneficiary and the debtor's social security nusber is unknown, show •unknown.' In the event that the debtor is a corpora- tion or a partnership, show the tax identi- fication nunber of the corporation. If the tax identification nmber of the corporate or partnership debtor is unknown, show •unknown.* Show any other neae(s) (alias(es)) used by the debtor. If the debtor is a sole proprietor, show the new under which the sole proprietor conducts business (e.g., d/b/a (doing business as) Smith's Sundries). If no aliases, corporate, partnership, or sole [itVHIL ietfckt jtiip nones are used by the debtor, or known, show "Not applicable" or •Unknown." *_/./. ------- Appendix Exhibit A-7 ZXBl 4: Show the nsne(s) the debtor used on the initial instrument (e.g., application for benefits or loan application) which gave rise to the indebtedness. RBI 5: Show the debtor's complete present residence ~ ; -." 'address* i.e.,.:address of dwelling in which the dabtoFTTves so that he or she may be found for personal service of legal process (mrplaip* *** «M"na»«). Do not provide a lost Office Box aJJiujs asThe residence address. fine U.S. Postal Service will con- vert a Post Office BOB addran to a residence street address upon written request.] It is necessary for the united States Attorney to have current residence infonation in order to aaJoe proapt and effective service of proc- • -. • ^ttBi-Bjsae.'of the ,oBuntylo^llBB^'*^MBa^Vl''^fBaP ^^4*A "' that verified the debtor's present telephone nuober (e.9., the document which verifies or the acLhod used 60 aeJce the verification) and the aost recent date within the last six Berths that the debtor's present telephone muter was verified. RBI 9t Show any information which will assist the united States Attorney in relocating the he •cc-she.JBBM «fnji. *».-•. and telephone nunbers of relatives who say wading address which the debtor left with neighbors or an eaployer, or the debtor's drivers license nusfaar. If the the debt to or. IE the agency a ma««i'Bial credit VTRRA firnm-nll »nt>o flirtfn-rr*f ------- Appendix Exhibit A-7 bureau, include the date the debt was reported and the name, address and telephone number of the oonrnercial credit bureau to which [Stamping "Address Correction Requested' under the return address block on envelopes mailed to the debtor will alert the U.S. Metal Service to infonn the creditor agency of changes in the debtor's address. Registered Bail with forwarding and return-receipt requested is also an effective way to locate debtors. In addition, the O.S. Postal Service retains change of address notices for one year after they have been filed by a patron.] to the case of a corporate debtor, include the current residence address of the prin- cipal officers of the corporation. Where there is a legal successor in interest to the corporate debtor, the sane information requested in Item 5, above, and this item, should be provided for the successor party or corporation. •am CIAJM ITEM lOt Briefly describe or characterize the claim or cause of action (e.g. , •Social Security Administration benefitoverpaynent under U.S.C. S "). t Describe in particu- ira ran 12: _ larity the nature and type of benefit ever- payment, loan default, or other action by the debtor which gave rise to the claim. As •now in the parenthetical example above, be sure to identify the statutory, regulatory, or other authority from which the claim arose. In the event the debtor has filed a bankruptcy petition, include bankruptcy related information in the description of the claim or cause of action. Attach a copy of the initial notice to the debtor of the benefit uam.y*yueHt loan default, etc. Show the last date (month, day, year) on which suit can be brought to recover the claim or debt, i.e., toe statute of limi- tations (SOL) data. Show the basis for SOL (statute of limita- tions) date, e.g., the default date, date ent. As of last payment a general rule, unl FXFSA Gbapllance/Eoforceaent A-46 If mil a 1 ------- Appendix Exhibit A-7 13s ZZB4 14: 1994 15: IHM 16: 17s the debtor made a partial payment on the debt, the statute of limitations date would be based upon the date the agency first bacaea aware of the debt. In the event a partial payment was mate by the debtor, the statute of limitations date would be based upon the date of the debtor's last peyment. (See 28 OA.C. $2415 which pro- vides, in part, that ". . . every action for money damages brought by the united State* . . . shan be barred unless the complaint is filed within six years after the n£ht of action accrues • * < in the event of later partial payment or written acknowledgment of debt, the V^flt^h f^f ^af*^4fVl anHjiH r^a> fbaaaaaWl ^n 'again at the time of each such payment or . . .') ;vBxv ^BM^aBc*<(month, dey> '^aar) vn which the first agency demand for payment was made on tsie debtor. Show the name of the agency official, agent, or office that made the first demand for payment on the debtor. Show bow the first agency demand for payment was conaunicated to the debtor (e.g., by letter, mailgram). Show tha date (month, day, year) on which the last agency demand foe payment was made on the debtor. or office that made the last demand am 18: nat 19: Show how the last agency demand for payment was communicated to the debtor (e.g., by letter, telephone, personal contact with the debtor)• Briefly explain the debtor's response, if any, to the agency's rtaanmli for payment, faer)-«< any • in 4Mhich isuch unicated to the agency (e»g., by letter, telephone, personal contact). If the debtor did not respond to the agency's demands for payment, stew -7- FIFKA A-47 1983 ------- Appendix Exhibit A-7 TOM 30: If the debtor denied the claim, in «*»le or in pert, give the date (month, day, year) of such denial and explain how the debtor's denial of the claim was mad* known to the agency (e.g., letter, telephone call, person- al interview). Briefly explain the debtor's position with respect to the claim, if kno*n. Explain any defenses that the debtor raised or can be expected to raise with tespGLt bo the claim and the Merits of such defenses. ITEM 21: ITEM 22: Attach copies of any agency records docu- menting the debtor's denial. If the debtor did not dispute the claim, in W»le or in part, show "Claim not disputed by debtor." Briefly explain any agency response to the debtor's denial of the claim. Attach copies of any agency response to the debtor's denial, in whole or in part, of the claim. Otherwise, show 'Ha agency response." If the claim we* not disputed by the debtor, show "Mat applicable." Briefly describe any administrative remedies and/or rights available to the debtor (e.g., application for waiver, request for recon- sideration, appeal, etc.). Explain how the debtor was apprised of the availability of those remedies and/or rights, and what action was taken by the debtor with regard thereto. 9ew the date (month, day, year) of any such application for waiver, request for recon- sideration, or appeal. Attach copies of any docunents evidencing such debtor's application for waiver, request Cor reconsideration, or appeal. Explain what agency action was taken in response to the debtor's exercise of or attempts to exercise rights to administrative remedies. Sou the date (month, day, year) of any such "agency action" and attach copies of docunents evidencing the same. Explain any •technical defenses" (procedural deficiencies) that the debtor has raised or can be expected to raise with respect to the claim and the merits of such defenses. (Defenses to the merits of the claim, as distinguished from •technical defenses,' are to be discussed under Items 20 and 21.) Describe and discuss the merits of any counterclaim by the debtor against the united States, as well as any claim for offset whish the debtor may assert. -8- FIFEA Gmpliance/Enforcesjent A-48 Guidance _ffaniu» 1 ------- Appendix Exhibit A-7 XXEM 23: Show the amount and date (month, day, year) of any oomprcmise offer made by the agency or elicited from the debtor. HEM 24< , Briefly explain whether the compromise offer ; .was elicited from the debtor or offered to the debtor by the agency. Explain the basis of or reason for the amount of the compro- mise offer, if known. 25s Show the agency or debtor's response (speci- fy which} to the aaiptuniiee offer and the reason for the acceptance or rejection of the offer in compromise (e.g., "the debtor asserted that he had no funds with which to pay the compromise offered by the agency* ' discretionary expenditures are 10 times the RBI 26* Show the named) and present residence address(es) of any other peraon(s) liable for repayment of the debt (e.g., benefici- corporate officers)• Jhe present residence aJJieat provided should be that of the dwelling in which the person lives so that he or she may be personally served with legal process (camplaint"anS swoons). If .no other person is legally responsible for the debt, show "tone.* 27s other pertiee. •ftcDl«ini------- Appendix Exhibit A-7 how the claia arose (including the statutory, regulatory, or other authority from which the claia arose, a sunaary statement or resume of tbe factual basis for the claim, an itsni- sation of the dates and amounts of any pay- ments aade by the debtor to tbe agency or any credits aade by tbe agency to the debtor, and an itemization of the anoint due and owing) and should be fix the fr" amount of the debt show) on the first page of the report. Attach tbe Certificate of Indebtedness to the report. Zn the event that the debtor bee filed a bankruptcy petition and if tbe nature of the security agreement and the property In which tbe Ohited States has a security interest is each that tbe debtor can reaffirm the debt, then list the number, dates and amounts of t to which the debtor is in 29s Iw. fel. ay cn Although there nay be aany exceptions, this anoint will usually be the principal anoint of tbe indebtedness before the accrual of interest and be Cure the debtor has aade any payments. net 30: 9>ow the *•**•! Hir*TT and anoint of any payeents made by the debtor to the agency or tbe agency's assignor, or any credits made by the agency to the debtor, foe example, if 5 payments of$25.00 each, enow •5 psy*ants/$125*; if 2 credits of$30.00 each, show -2 credits/560.' indicate the nature of such paynenta or credits, i.e., whether they were, for exanple, by dHset, lunp sun or installaent. If no pavaents or credits ware aade, show "None.' 31t 32: 33: Zf peyacnts or credits were Bade, sikjw the anoint which was applied to the principal of the debt. Otherwise, show "Mot applicable." Show the total anoint which MS applied to any administrative charges asamsed by the agency, any penalty chargee • ' by the agency, and the interest due on the principal anoint of tbe debt, if applicable. Zf not, show "Not applicable." Show tbe remaining balance due on the prin- cipal anouiL of the debt. Zn the event that the debtor has filed a bankruptcy petition, show the balance due on tbe principal as of tbe date tbe petition tea filed. -10- FIFRA Ompliance/Enforceaent A-50 Guidance Manual 1983. ------- Appendix Exhibit A-7 TTEK 34: Show the balance due on any administrative charges assessed by the agency, any penalty charges aanesiwil by the agency, and the accrued interest en the principal anoint of the debt, if applicable. If not, snow "Mat applicable.* m the event that the debtor has :\ filed a bankruptcy petition, show the interest doe Co the date the petition was filed and daily »"•'•"»* of interest Uif'••^*M'- ZXEN 35s Bcplain how piysants received from the are to be applied. Rnally, tfcen a debt is paid in partial or instaUnent peywnts, aaouits received by the agency should be applied first to any outstanding administra- tive onsBges which have been assessed by the agency pursuant to the Debt Collection Act of - 1962,-P.U 97-365, lll(eH2Jr second, to any by the agency tor debtor's failure to pay any portion of a debt sere than ninety (90) days past **» pursuant to the Debt Collection Act of 1982, P.L. 97-365, 511(e)(2)> third, to principal. • RBI 36: Show the laanrit and date (spnth, day, year) of the last psjsMnt which the debtor svde to the agency or the agency's assignor. RBI 37* Show the interest computation or interest accrual date (i.e., the date from which interest is dueT7~if applicable. If not, stow "Not applicable." RBI 38: Snow the naee, cpopieta address and telephone nuBtaer of the debtor's present eaployer. If the debtor's actual place of work is different fraa the espiLoyer's address and is know, provide the eddieee and telephone nueber of the debtor's vork place. This infatuation «U1 assist tfae Dnited States Attorney in asking i»in%< service of p * i •»• .upon the or'her XXBl 39: Show the date (Berth, day, year) the debtor's enployBant was verified by the agency within the past sin sonths, and the *WIPP* of that verification (e^., the debtor, debtor's -11- FIFRA Govpllance/OiforcesKnt A-51 Guidance Manual 1983 ------- Appendix Exhibit A-7 ZIBt 40: Show the debtor's weekly or monthly salary and indicate whether the amount shown is gross or net salary. For example, ahow •$350/weekly/gross.• REN 41 j Show tne date (month, day, year) the salary was verified by the agency within the past six months, and the source of that verifi- cation (e.0^, the debtor, debtor's employer, current documentation). HEN 42: If applicable and known, show the name, address and telephone rof1"'1^' of the spouse's employer. If none of the information is available, ahow "Nat available.' REN 43: If applicable, ahow the date (month, day, year) the spouse's employment was verified by the agency within the past six months, and the source of that verification (e.g., spouse's employer, current documentation). If none of the information is available, show "Mot available." DEBIOt'S ABttRY 10 VKt 44: Explain the evidence that discloses and the basis for the agency's deteonination that, given the debtor's present or likely future avaiiaEITity at assets or income, a sub- stantial sum may be obtained by enforced collection proceedings against the debtor. in* agency's determination should take into account any exemptions to which the debtor is entitled under state and Federal law, the debtor's age and health, the debtor's education, present and potential income, number of dependents, inheritance prospects, and the possibility that assets have been concealed or improperly transferred. Also, provide information concerning any legal proceedings, such as proceedings in bank- ruptcy, that may affect the government's ability to collect the debt. Attach to the report all supporting documentation including, for example, a current credit tepuit or financial statement. In the event of a eaporatje debtor, an audited balance sheet of the corporate be attached. -12- FIFRA Grapllance/EoforceBent A-52 Guidance Manual 1983 ------- Appendix Exhibit A-7 (tote: A realistic determination of a debtor's financial ability to pay is essen- tial to enforced collection, particularly with regard to small, unsecured claims. ine financial evidence which is provided to the united States Attorney oust be current tfJQ iflssVsVJBufftaB *tPQi sVUVt QiSdO8B tftsSt tn1^ debtor has sufficient incomt to pay the debt, or unencuBbered non^exenpt assets, real or personal, which can be used to liquidate the debt. Generally, if there is insufficient incase or unencumbered to meet the debtor s •necessaries" (i.e., indispensable things, or things proper and useful, oar day-to-day living, sucb as food, clothing, medical attention, and a suitable place of resi- »), the^date should not be Deferred to or litigation and enforced collection. A good rule of tbuab tor determining whether there is a rsesnnshle |s.>jspeut for c.forced collection of a substantial SUB on a •••ail, unsecurea" cZJum is tnet sucna claim should not be referred unless the evidence provided diwcloees that tfae^debter has sufficient to pay for 'necessaries* and at$1800 over a 3-year period7"or that HEM 45: or property which is at least 10 times greater in value than the amount of the obligation. Provide any Information which will assist ^m»l [|[j £SSl in *ieh the 'Ghited States has or may have a security 'nterest. Describe and give the last Jmown location of such property. Describe *nd attach security agreements or real estate or chattel sortganes which give the United States a security interest (e.q., papers in the agency's file which describe or show what ptm«ety was pledged). Show the asset cr fair market value of any such real or JJSITsuual jjBaisu. ty 4or •------- Appendix Exhibit A-7 ITEM 46: XTBt 47: Provide any information tnich will assist the Qhited States Attorney in locating other assets of the debtor (i.e., assets other than pledged pixipetLy snowh in Item 45). Particular care should be given to identifying Hjn-eaemjt assets of the debtor (e.g., real estate which is not the hone- of the debtor, a second vehicle, •tional vessels, etc.). In the of a corporate debtor, provide any information which will assist the united States Attorney in locating other assets of the corporation. If this information is unknown, show "Unknown." VAIJ3E Of CLAIM Show and explain the fair csrket or asset value of the claim, i.e., the amount of cash which may be realized as a result of litigation of the claiau Bcplain the • basis tor the value given. The agency's determination of the value of the claim should be based in part upon the ratio which the amount of the claim or debt bears to the aeount of the debtor's assets and income which can be realized by enforced collection and upon the unencusbered value (after prior liens have been satisfied) of any property of the debtor in tciicb the United States has a seemed interest. The information provided should reflect the true value of the claim and, thus, enable~a»e United States Attorney to sore accurately determine the amount which the government is likely to recover by enforced collection. See the rule of thunb in the Note at Item 44, above, for determining whether there is a reasonable prospect for 48t enforced collection of a. substantial sum. With due regard to the debtor's ability to pay as definedby Item 44, above, show the which the claim can reasonably be settled the aeount shown. This aeount should bear a direct relationship to the debtor's by garnishment, levy, or attachment. The agency's iei.i'mmii»1srln» will provide the United states Attorney with the -14- FIFKA Gnaplii i/Eofor A-54 Guidance Manual 1983 ------- Appendix Exhibit A-7 intonation and guidance for an informed consideration of any compromise offer or settlement the debtor may mate. Further- more, having such information beforehand will eliminate the delay and expense which wuld otherwise be necessary for the united States.Attorney to obtain the agency's assessment of a debtor's "ry'^** offer made after the claim has been referred to the united States Attorney. TRANSFER OR lliHHrr CEFQSIT Of FCND6 IBM 49t Show the name, title, complete mailing address and PIS telephone HIST^T of the agency official at the accounting code   Federal Insecticide, Fungicide, and Rodenticide Act COMPLIANCE/ENFORCEMENT GUIDANCE MANUAL U.S. ENVIRONMENTAL PROTECTION AGENCY Washington DC 20460 Prepared by Pesticides and Toxic Substances Compliance Monitoring Staff and Office of Legal and Enforcement Policy ------- Table of Contents Chapter One; Overview Purpose of the Manual Overview of the Act The Federal Insecticide, Fungicide and Rodenticide Act (As Amended) FIFRA Regulatory Elements Registration of Pesticides Establishment Registration Pesticide Disposal Experimental Use Permits Emergency Exemptions for Federal and State Agencies State Registration of Pesticides Glossary Chapter Two; General Operating Procedures Primary Office Responsibilities Concurrence Procedures State and Federal Interagency Cooperation Organizational Charts Chapter Three; Compliance Monitoring Procedures Introduction Inspections Records and Establishment Inspections Use/Misuse Investigations Warrants Subpoenas Chapter Four; Documentation of Evidence Introduction Inspection File Review Review of Adequacy of Evidence FIFBA ^^"•pl * MTtf^/itnfnfffmfmt- Guidance **"«">« 1983 ------- Chapter Five; Determination of Appropriate Enforcement Response Introduction 3 a ••,&#'• Level of Action Policy • '-•-:. ?rr: jS i.'-. Chapter Six; Administrative Enforcement Actions; Notices of Violation and Administrative Orders Introduction Administrative Enforcement Procedures Chapter Seven; Administration Enforcement Actions; Civil Penalty Proceedings Introduction Elements of a Violation: Administrative Complaint Preparation and Filing Pre-Hearing Stage Hearing Stage Post-Hearing .Stage Chapter Eight; Judicial Enforcement; Civil Actions Introduction Elements of a Violation: Civil Procedures for Filing Actions Injunctive Actions In Bern (Seizure) Actions Settlement Agreements Chapter NlTte^ Judicial Enforcement; Criminal Actions Statutory Authority Basic Enforcement Policy Criteria for Identification of a Potential Criminal Action Procedures for the Investigation and Referral of a Criminal Case Chapter Ten; Post-Settlement Enforcement Monitoring Settlement Agreements Enforcement of Settlement Agreements Chapter Eleven; Special Considerations TXZ1A .Section 7 Confidential Information Disclosure of Confidential Information FIFKA Compliance/Enforcement Guidance Manual 1983 ------- Appendices Neutral Administrative Inspection Scheme Notices of Judgment Sample Record Status and Permanent Abeyance Procedures Collection of Civil Penalty Assessments Expert Witnesses Penalty Policies Additional Sources of Compliance/Enforcement Information FTFRA Covpllaiice/Enforceaent Guidance n*™*! 1983 ------- Chapter One Overview Chapter Contents Page 1 Purpose of the Manual 1-1 Reservation 1-1 The Update System 1-1 Common Acronyms and Abbreviations Used in this Manual 1-2 2 Overview of the Act 1-3 Purpose and Scope 1-3 Authorities and Responsibilities 1-4 Synopsis of the Act 1-4 3 The Federal Insecticide, Fungicide, and Rodentlcide Act 1-13 (As Amended) 4 FIFRA Regulatory Elements 1-47 4a Registration of Pesticides 1-49 Applicability of Registration Requirements 1-49 Registration Procedures 1-51 Labeling Requirements 1-54 4b Establishment Registration 1-55 Authority 1-55 Objectives 1-56 Applicability of Registration Requirements 1-56 Registration Procedures 1-57 Establishment Registration Numbers 1-58 Establishment Production Reports 1-59 l-i g^±4fnf» u^mmi 1983 ------- Ac Pesticide Disposal 1-63 Authority 1-63 Enforcement Actions and Disposal Practices 1-63 4d Experimental Use Permits 1-65 Authority 1-65 Scope 1-65 Permit Application Procedures 1-65 Labeling Requirements 1-66 4e Emergency Exemptions for Federal and State Agencies 1-67 Types of Exemptions 1-67 Procedures To Be Followed 1-68 Withdrawal of Exemptions 1-70 4f State Registration of Pesticides 1-71 Conditions for Section 24(c) Registration 1-71 Types of Section 24(c) Registrations 1-71 Registration Disapproval/Suspension 1-72 5 Glossary 1-73 FIFRA CbppllOTCf/Enforcement1-11 ------- Chapter One 1 Purpose of the Manual The purpose of this manual is to provide guidance to pesticide regulatory personnel on the substantive and procedural requirements necessary for ensuring compliance and preparing enforcement cases under the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (FIFRA). The manual describes the processes of case development and Judicial pro- ceedings including the analyzing of evidence collected during a compliance inspection to determine its sufficiency to document a suspected violation; issuing of an enforcement action; presenting evidence in an adjudicatory hearing; and monitoring compliance with consent decrees. Reservation The policies and procedures set forth herein and the internal office proce- dures adopted pursuant hereto are intended solely for the guidance of U.S. Environmental Protection Agency personnel. These policies and procedures are not intended to be relied upon to create a right or benefit (substan- tive or procedural) enforceable at law by a party to litigation with the United States Environmental Protection Agency. The Agency reserves the right to take any action alleged to be at variance with these policies and procedures or that is not in compliance with internal office procedures. The Update System As revised or additional material is developed for the manual, it will be distributed to all manual holders. A transmittal form will accompany and explain these changes. The revised or additional pages will be Identical to the original page, but with added identification at the bottom of the page. Pag* CkiMoe* Haimil (T*ir) FIFMA compliance/mxorcement 1-1 Guidance narnuii ------- Chapter One When revisions entail the addition of pages into the manual (i.e., when three pages in the manual are replaced by five pages), the additional pages will be numbered as follows: Original numbering: 3-3, 3-4, 3-5, 3-6, etc. Addition of pages: 3-3, 3-4, 3-5a, 3-5b, 3-5c, 3-6, etc. This system will allow updates to be made quickly and easily and will avoid disruption of the chapters. New material will be numbered sequentially by chapter. Common Acronyms and Abbreviations Used in this Manual C.F.R. — Code of Federal Regulations CROP — Consolidated Rules of Practice EPA — United States Environmental Protection Agency FDA — Food and Drug Administration FIFRA — Federal Insecticide, Fungicide, and Rodentlcide Act, as amended HQCDO — Headquarters Case Development Officer OLEC — Office of Legal and Enforcement Counsel PTSCMS — Pesticides and Toxic Substances Compliance Monitoring Staff RCDO — Regional Case Development Officer RD — Registration Division RHP — Restricted Use Pesticide SSDRO — Stop Sale, Use, or Removal Order U.S.C. — United States Code 1-2 Gold ------- Chapter One 2 Overview of the Act The Federal Insecticide, Fungicide, and Rodenticide Act, Public Lav 92-516 (1972), as amended by Public Lav 94-140 (1975), Public Lav 95-396 (1978), and Public Lav 96-539 (1980) vas passed by Congress as the primary statute for pesticide control and regulation. The Act, referred to as "FIFBA," is codified in Title 7 of the United States Code. Regulations promulgated pursuant to the Act are found at 40 C.F.R. Parts 162 through 180. Purpose and Scope FIFRA and its amendments are designed to provide for pre-market clearance of pesticides and post-market surveillance of pesticides and pesticidal devices to ensure prevention of unreasonable adverse effects upon human health or the environment. Under FIFRA, the term "pesticides" Includes: • Substances (other'than "nev animal drugs" or animal feeds) intended for preventing, destroying, mitigating, or repelling any "pest" defined to include organisms ranging from viruses and bacteria to rodents; and • Substances intended for use as plant regulators, defoliants, or dessicants. The Act prohibits (subject to certain exceptions) any Individual from • , distributing, selling, offering or holding for sale, •hipping, delivering for shipment, or receiving and (having so received) delivering or offering to deliver any pesticide product not registered with the Administrator of EPA. Registration may be refused, restricted, suspended, or cancelled $>y the Administrator where appropriate to ensure protection of the environ-r ment. Under the Act, all producers of pesticides and pesticidal device* ere required to register their establishments with the Administrator«1 FIFRA Case Proceedings Manual 1-3 ^^M Manual 1983 ------- Chapter One Overview of the Act Products Not Subject to the Act Certain products are not classified as pesticides and, therefore, are not subject to the Act. They include: -« Deodorizers, bleaching agents, and cleaning agents for which no pesticidal claims are made; • Paints and other formulated coatings that are treated with fungi- cides to protect the coating Itself and that bear no claims for protecting other: surfaces or objects; • Building material products (such as lumber, fiber boards, adhe- sives, and caulking material) that have been treated to protect the material Itself against pests and for which no pesticidal claims are made as to protecting other surfaces or objects; • Fabric products that have been treated to protect the fabric itself from insects, fungi, or other pests and .for which no pesticidal claims are made as to protection of other surf aces or objects; • Fertilizers and other plant nutrients; and • Intermediate substances intended for the production of a pesticide product by chemical reaction with other substances. Authorities and Responsibilities _____ The Administrator of EPA Is authorized to administer the Act In a reason- able and prudent manner, often considering the economic, social, and environmental costs and benefits of actions taken under FIFRA. Within EPA, several offices are responsible for providing national guidance for FIFRA compliance enforcement activities. These offices and their responsibili- ties are discussed in Chapter Two. of the Act _ FIFRA authorises the registration of pesticides as veil as pesticide- producing facilities. Specific authorities are provided for the inspection of establishments, books, and records. The Act also provides for classifi- cation of pesticides for general use or restricted use; certification of jBfipJLieatoxs £ or jesrrigted «sc pesticides; Issuance of experimental use ts; mud promulgation of pBsticide application standards . Protection is afforded trade secrets and certain other business information deemed confidential by the registration applicant. Provisions are made under the Act for imposition of civil or criminal penalties. msqinsnrr/imrnrrrmciiL A—«» Guidance HSU*"' 19V3 ------- Chapter One Overview of the Act Procedures for issuing a stop sale, use, or removal order (SSURO) or seizing violative pesticides or devices are detailed. The statute also provides authority to enter into cooperative agreements with the States. These sections of FIFRA are briefly reviewed below. Registration of Pesticides (Section 3) Applications for registration must include information relating to the labeling of the pesticide as well as the labeling Itself, a statement of all claims made by the manufacturer, and directions for using the pesti- cide. The Administrator is required to publish guidelines for the submission of Information in support of the application. In general, an application will be approved when the information submitted supports the assertion that the pesticide will perform its claimed function(s) and indi- cates that the pesticide will not present an unreasonable risk to the environment when used properly. The Administrator is required to classify all pesticides for either general or restricted use or both; may condition- ally register pesticide products that are Identical or substantially similar to those currently registered; and may approve new and added uses of currently registered pesticides. The Administrator is required to accomplish the re-registration of all pesticides in the most expeditious manner practicable. Use of Restricted Use Pesticides; Certified Applicators (Section 4) EPA must establish standards for the certification of pesticide appli- cators. For those States that do not have a State certification plan approved by the Administrator, the Agency is to conduct its own certifica- tion program for pesticide, applicators. Approval of a State's certi- fication program may be withdrawn if the Administrator determines that the State program Is not being administered in accordance with the terms of the approval. Experimental Use Permits (Section 5) Any person may apply to the Administrator for an experimental use permit for a pesticide. Approval of the experimental use permit is conditional upon the Agency's review of the application and all required supporting data, as well as the applicant's need for Information to support the regis- tration. The permit may specify terms and conditions deemed appropriate by the Administrator. Should these terms or conditions be violated, or inade- quate to avoid an unreasonable adverse effect on the environment, the permit may be revoked. A^p<"istrative Review; Suspension (Section 6) The Administrator shall cancel the registration five years from the date of registration unless the registrant or other interested person requests the continuance of the registration in accord with re-registration regulations fIFRA Compliance/Enforcement 1-5 ------- Chapter One Overview of the Act prescribed by the Administrator. The Administrator may cancel or change the classification of a registered pesticide if it is determined that its labeling or other material required to be submitted is not in compliuace with the Act or if the pesticide causes unreasonable adverse effects to tne environment. The Act requires that notice of the order be sent to the registrant and be made public. A hearing to dispute the order must be provided to any person adversely affected by the notice. The Administrator can also cancel a registration that was Issued conditionally if the regis- trant fails to meet any condition imposed or falls to Initiate and pursue appropriate action toward fulfilling any condition Imposed. Section 6 further provides that If a pesticide is determined to be an imminent hazard during the period required for cancellation or change of registration proceeding, its use may be Immediately suspended by the Administrator upon proper notice and availability of an expedited hearing. Registration of Establishments (Section 7) Any establishment producing pesticides, active ingredients used in produc- ing pesticides, or pestlcldal devices must be registered with the Administrator. Information submitted in this registration process, other than the names of the pesticides or active ingredients used in producing pesticides, will be subject to the confidentiality provisions of Section 10. Books and Records (Section 8) The Administrator may prescribe regulations requiring producers to maintain records pertaining to their operation as veil as pesticide and device records considered necessary for the enforcement of the Act. Financial data, sales data other than shipment data,, pricing data, personnel data, and research data other than data relating to a registered pesticide or pending registration are exempt from this rule. Inspection and copying of shipping records or, in the absence thereof, records relating to shipment are permitted upon presentation of proper credentials by a duly authorized employee of EPA or any State. i Inspection of Establishments (Section 9) T&XA authorize*, upon presentation of proper rcredentiale and -notice, the Inspection (at reasonable times) of establishments or other places where pesticides and devices are held for distribution or sale. A written notice, detailing the reason for the inspection and noting whether a viola- tion of the law is suspected, must be presented prior to entry. Inspectors •ay obtain camples of any pesticides or devices that are packaged, labeled, and released for shipment and samples of any such containers and labeling. If necessary, tarranf* may fee obtained from a district court to gain entry« Jjvpeet* and reproduce certain -records relating to pesticides or devices, or to seize any pesticide or device. For minor violations, a written notice of warning may be issued. FI7MA compliance/mx or ceeent l-o Guidance Manaaj. 190J ------- Chapter One Overview of the Act Protection of Trade Secrets and Other Information (Section 10) This section of FIFRA provides for the protection of trade secrets and certain business information obtained under FIFRA. Applicants may claim Information as confidential or dispute the release by the Administrator of any information the manufacturer feels is confidential. United States employees who willfully disclose trade secrets are subject to criminal penalties. Standards Applicable to Pesticide Applicators (Section 11) Separate standards for licensing and certification are established for commercial and private applicators. Private applicators are not required to maintain any records or to file any reports. Unlawful Acts (Section 12) * Section 12 establishes the acts that are unlawful under FIFRA. These include, inter alia, registration, labeling, and use violations. See Chapter Seven for a complete listing. Stop Sale, Use, or Removal and Seizure (Section 13) The Administrator may issue a stop sale, use, or removal order under the following circumstances: • When, based on inspection or tests, there is reason to believe that a pesticide or device is in violation of the Act or will be sold or distributed in violation of the Act; or • When the registration of a pesticide has been cancelled or suspended. Additionally (if certain unlawful acts are being carried out), pesticides or devices may be seized for condemnation upon action In a district court. Penalties (Section 14) Any registrant, commercial applicator, wholesaler, dealer, retailer, or other distributor who violates any provision of the Act Bay be assessed a civil penalty of up to$5,000 per offense. Should any of the above- mentioned parties knowingly or willfully violate the Act, a criminal penalty of up to $25,000 and/or Imprisonment for up to one year may be imposed. A private applicator or other person not Included above who violates the Act after receiving a warning letter or citation for a prior violation may receive a$1,000 civil penalty for each subsequent offense. "For hire" applicators may be fined $500 for the first offense and$1,000 FIFgA Ooapli«nce/Enf orceaent 1-7 "Guidance" ------- Chapter One Overview of the Act for each subsequent offense. Criminal penalties for private applicators and "for hire" applicators may be a fine of up to $1,000, 30 days' Impri- sonment, or both. Indemnities (Section 15) Under certain conditions EPA may make indemnity payments to persons suffering losses due to the cancellation or suspension of a pesticide registration. Administrative Procedure; Judicial Reviev (Section 16) District courts are given authority to review those Agency final actions that are not given to agency discretion by lav. These courts are also vested with jurisdiction to enforce, prevent, and restrain violations of the Act. United States courts of appeals have exclusive jurisdiction to affirm or set aside an order issued by the Administrator. All judgments entered In actions instituted under -the Act are to be published. Imports and Exports (Section 17) Pesticides and pesticidal devices may not be imported for use In the United States If they violate any provision of the Act. Pesticides or pesticidal devices Intended solely for export nay be produced and packaged according to purchaser specifications but will be subject to certain provisions of Sections 2, 7, and 8 of the Act. Exemption of Federal Agencies (Section 18) The Administrator may exempt Federal and State agencies from any provision of the Act under emergency conditions. Disposal and Transportation (Section 19) Procedures and regulations for disposal and storage of pesticides must be established. The Adminlntrator will advise «nd c*8ist the Department of "Traaaiportatlon In matters relating to ^he transportation of hazardous materials. If a pesticide Is cancelled under Section 6(c), the Administrator, at the request of the pesticide owner, Is to provide a safe disposal site. Specific provisions for the disposal of unused quantities of a cancelled pesticide must appear In the notice of cancellation. HF1A ampliance/Bof orcement 1-8 Guidance Manual 1983 ------- Chapter One Overview of the Act Research and Monitoring (Section 20) Research necessary to carry out the Act is authorized. The Administrator will formulate and carry out a national plan to monitor pesticide exposure and pollution. Solicitation of Comments; Notice of Public Hearings (Section 21) The Administrator must solicit the views of the Secretary of Agriculture prior to publishing regulations and may solicit, from other interested persons, views relating to any action authorized under the Act. Timely notice of all public hearings must be published in the Federal Register. Delegation and Cooperation (Section 22) The Administrator may delegate to EPA employees any or all vested authority contained in the Act. The Administrator must cooperate with other agencies in carrying out the Act. State Cooperation, Aid, and Training (Section 23) The Administrator may enter into cooperative agreements with States and Native American Indian tribes for the purposes of delegating authority to carry out the Act and to train personnel. The Administrator also may assist them with contracts to encourage training certified applicators. Authority of States (Section 24) A State may regulate the sale or use of any federally registered pesticide or pesticidal device to meet its special needs, as long as it is in accor- dance with the Act. The State may register new uses for registered pesti- cides for use only in the State. The new use may not be a food or feed use unless it is consistent with the Federal Food, Drug, and Cosmetic Act. With just reason, the Administrator may suspend the State's authority to register pesticides under this section. Authority of the Administrator (Section 25) The Administrator nay prescribe regulations to carry out the Act* Proposed and ..final regulations must be given to the Secretary of Agriculture for comment. All comments will be published In the Federal Register on a pres- cribed time schedule. The House and Senate Agriculture committees must also be notified. A scientific advisory panel will comment on the regula- tions, using the same time schedule as the Secretary of Agriculture, and the comments will also be published in the Federal Register. Itrnpliance/Etafor ------- Chapter One Overview of the Act The Administrator has the authority to determine what is a pest, to specify which devices are subject to the Act, to establish packaging standards for pesticides and devices, to prescribe regulations requiring pesticides to be colored, to establish suitable names for use in active ingredient state- ments, and to determine whether pesticides are toxic to human health. State Primary Enforcement Responsibility (Section 26) A State has the primary enforcement responsibility for pesticide use viola- tions (primacy) if the State laws and regulations are deemed adequate by the Administrator, if sufficient enforcement procedures are adopted and used, and if the State keeps records and makes reports of such compliance as required by the Administrator. A State may also obtain primacy by entering into cooperative agreement for the enforcement of use violations under Section 23 or by demonstrating that their Section 4 certification plan meets the criteria described above. The Administrator has primary enforcement responsibility for States that do not have primacy. Failure by the State To Assure Enforcement of State Pesticide Use Regulations (Section 277 The Administrator must notify the State of any significant allegations of a pesticide use violation of the Act. If within 30 days of the referral the State has not commenced appropriate enforcement action, EPA may bring its own action. The Administrator is empowered to rescind primacy if it is found that the State is not carrying out its pesticide use enforcement responsibility. If an emergency exists and the State is unable or unwilling ;to'^respond, ^the Administrator is authorized to action. Identification of Pests; Cooperation with Department of Agriculture's Program (Section 28) The Administrator, In coordination with the Secretary of Agriculture, Is to identify those pests that must be controlled.. -In. addition, the *•*•*«»*«*»•»»•*«• 4 « »« coordinate *lth the Secretary of .Agriculture *s research and Implementation programs in order to determine the safest and most effective pesticides or control methods available. Annual Beport (Section 29) An f«»T«M»i xeport must be submitted to: Congress igr the Adaliilstrstor before 16 *>f - each year » llstlTig all the applications for conditional FXTKA. Uumplimnri*/Enff>-rf*mt>*tt- 1—10 ^'*lff"'** MOT***1 1983 ------- registration and approvals of such applications. The findings, imposi- tions, modifications, and quantities of each conditionally registered pesticide that is produced must be included. fUFHA. Compliance/Enfor 1-11 Guidance 1933 ------- Chapter One Overview of the Aft- ruts* ump.Liance/EQ±orce»ent ------- Chapter One 3 Federal Insecticide, Fungicide, and Rodenticide Act CAs Amended] La* 92-Stt, Kmt Cityim, HJt. 10739, Omkm U, 1972 Law M.51. tt* Caavwa. HJL 43T7, My 2. 1973; Lav M.IM. Mak Ciaraa. S. 2375. Qtntir 10, 1975; Law M.I4*. M* CaaanH, HJL SS41, .Ntnartrr 2S. 19*5: Law 95-231, 93* CoapM. HJL 6975, Mart* 27. 1978: Uw 99.394. 95ta Caaaru*. S. K7S. ScateMtar M. 1978: o«tm§. Dict«>y 17. 19W) fln flct Ktdcral l-nvironmcnlil Pmicidt Control Ao ol 197:. 61 Slic. 163: 71 Sill. 190. 86 STAT. 973-999 To amend the Federal Insecticide, Fungicide, and Rodenticide Act, and For other purposes. Be it enacted by the Senate and House Representatives of the United Slates of America in Congress assembled. That this Act may be cited as the "Federal Environmental Pesticide Control Act of 1972." Amendments to Federal Insecticide, Fungicide, and Rodenticide Act Sec. 2. The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) is amended to read as follows: "SECTION 1. SHORT TITLE AND TABLE OF CONTENTS. (a) Short Title — This Act may be cited as the 'Federal Insecticide, Fungicide, and Rodenticide Act'. (b) Table of Contents — "Section I. Shori title and table of comems. "(a) Short tide. "(b) Table of contents. "Sec. 2. Definitions. "(a) Active ingredient. "(b) Administrator. "(c) Adulterated. "(d) Animal. "(e) Certified applicator, etc. "(I) Certified applicator. _ "(2) Private applicator. "(3) Commercial applicator. • "(4) Under the direct supervision of a certified applicator. "(0 Defoliant. "(I) Desiccant. ' "(h) Device. "(i) District court. "(j) Environment. "(k) Fungus. "(I) Imminent hazard. "(m) Inert ingredient. "(n) Ingredient statement. "(o) Insect. "(p) Label and labeling. "(I) Label. "(2) Labeling. P.I.. 42 Sill. »J» "(q) Misbranded. "(r) Nematode. "(s) Person. "(t) Pest. "(u) Pesticide. "(v) Plant regulator. "(w) Producer and produce. "(x) Protect health and the environ- ment. "(y) Registrant. "(2) Registration. "(aa) Stale. "(bb) Unreasonable adverse effects on the environment. "(cc) Weed. "(dd) Establishment. "(ee) To use any registered pesticide in a manner inconsistent with its labeling. "Sec. 3. Registration of pesticides. "(a) Requirement. "(b) Exemptions. "(c) Procedure for registration. "(I) Statement required. "(2) Data in support .of registra- tion. umpJJLance/jgnxorceaent 1-iJ Mirnnin 1983 ------- Chapter One FIFRA "(3) Time for acling with respect to application. "(4) Notice of application. "(5) Approval of registration. "(6) Denial of registration. "(7) Registration under special cir- cumstances. "_(%) Interim administrative review • "(d) Classification of pesticides. "(I) Classification for general use, restricted use. or both. "(2) Change in classification. "(3) Change in classification from restricted use to general use. "(e) Products with same formulation and claims. "(0 Miscellaneous. "(I) Effect of change of labeling or f01 mutation. "(2) Registration not a defense. "(3) Authority 10 consult other Federal agencies. "(g) Registration of pesticides. , "Sec. 4. Use of restricted use pesticides; certified applicators. "(a) Certification procedure. "(I) Federal certification. "(2) Slate certification. "(b) State plans. ."(c) Instruction in integrated pest ' . management'techniques. "Sec. S. .Experimental use permits. "(a) Issuance. "(b) Temporary tolerance level. "(c) Use under permit. "(d) Studies. "(e) Revocation. "(0 State issuance of permits. "(g) Exemption for agricultural research agencies. "Sec. 6. Administrative review;suspension... "(a) Cancellation after five years. "(I) Procedure. "(2) Information. "(b) Cancellation and change in classifi- cation. "(c) Suspension. "(I) Order. "(2) Expedite hearing. "(3) -Emergency order. "(4) Judicial review. Public heai ings and -scientific re- "Sec. Sec. • "Sec. "Sec. "(b) "Sec. view. "(e) Conditional registration. "(0 Judicial review.. 7. Registration of establishments. "(a) Requirements. "(b) Registration. "(c) Information required. "(d) Confidential records and informa- tion. , 8. Books and records. "(a) Requirement. **|b) Inspection. "(a) In general. _"(b)_ Warrants. ' ' "yita TiaM HBMII nTnin ------- Chapter One FIFRA "SEC. 2. DEFINITIONS. "For purposes of this Act— "(a) Active Ingredient.—The term 'active ingredient' means— "(1) in the case of a pesticide other than a plant regulator, defoliant, or desiccant, an ingredient which will prevent, destroy, repel, or mitigate any pest; "(2) in the case of a plant regulator, an ingredient which, through physiological action, will accelerate or retard the rate of growth or rate of maturation or otherwise alter the behavior of ornamental or crop plants or the product thereof; "(3) in the case of a defoliant, an ingredient which will cause the leaves or foliage to drop from a plant; and "(4) in the case of a desiccant, an ingredient which will artificially ac- celerate the drying of plant tissue. "(b) Administrator.—The term 'Administrator* means the Administrator of the Environmental Protection Agency. "(c) Adulterated.—The term 'adulterated* applies to any pesticide if: "(I) its strength or purity falls below the professed standard of quali- ty as expressed on its labeling under which it is sold; "(2) any substance has been substituted wholly or in part for the pesticide; or "(3) any valuable constituent of the pesticide has been wholly or in part abstracted. "(d) Animal.—The term 'animal* means all vertebrate and invertebrate species, including but not limited to man and other mammals, birds, fish, and the shellfish. "(e) Certified Applicator, Etc.— "(I) Certified applicator.—The term 'certified applicator' means any individual who is certified under section 4 as authorized to use or super- vise the use of any pesticide which is classified for restricted use. Any applicator who holds or applies registered pesticides, or use dilutions of registered pesticides consistent with section 2------- Chapter One PIFRA "(k) Fungus. — The term 'fungus' means any non-chlorophyll-bearing thallophyte (thai is, any non-chlorophyll-bearing plant of a lower order than mosses and liverworts), as for example, rust, smut, mildew, mold, yeasi, and bacteria, except those on or in living man or other animals and those on or in processed food, beverages, or Pharmaceuticals. "I) Imminent Hazard.—The term 'imminent hazard* means a situation which exists when the continued use of a pesticide during the time required for cancellation proceeding would be likely to result in unreasonable adverse ef- fects on the environment or will involve unreasonable hazard to the survival of a species declared endangered by the Secretary of the Interior under Public Law 91-133. «.iMa..:7.v "(m) Inen Ingredient.—The term "inert ingredient' means an ingredient IMIM MUUV.I. which is not active. "(n) Ingredient Statement.—The term 'ingredient statement' means a state- ment which, contains— *'(!) the name and percentage of each active ingredient, and the total percentage of all inert ingredients, in the pesticide; and "(2) if the pesticide contains arsenic in any form, a statement of the percentages of total and water soluble arsenic, calculated as elementary arsenic. "(o) Insect.— The term 'insect* means any of the numerous small in-. vertebrate animals generally having the body more or less obviously segmented, for the most part belonging to the class insecta, comprising six- legged, usually winged forms, as for example, beetles, bugs, bees, flies, and to other allied classes of arthropods whose members are wingless and usually have more than six legs, as for example, spiders, mites, ticks, centipedes, and wood lice. "(p) Label and Labeling.— "(I) Label.—The term 'label* means the written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers. "(2) Labeling.— The term "labeling' means all labels and all other written, printed, or graphic matter— "(A) accompanying the pesticide or device at any time; or "(B) to which reference is made on the label or in literature ac- companying the pesticide or device, except to current official publications of the Environmental Protection Agency, the United Slates Departments of Agriculture and Interior, the Department of Health, Education, and Welfare, State experiment stations, State agricultural colleges, and other similiar Federal or State institutions or agencies authorized by law to conduct research in the field of pesticides. "(q) Misbranded.— "on the label «r labeling is not . : pronuueudy placed thereon wit*i:suco compkuousness (as compared with other words, statements, designs, or graphic matter in the label- ing) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use; "(F) the labeling accompanying it does not contain directions for use which are necessary for effecting the purpose for which the product is intended and if complied with, together with any re- i us* i3«i. quirements imposed under section 3(d) of (his Act, are adequate to protect health and the .environment; * ••(Qtte'lRM.doesiBM caatraavnraagorc^ which ttgy-be necessary and if compiled1 with, together with any re- T use iite. quirements imposed under section 3(d) of this Act, is adequate to protect health and the environment; or PL ts-jw: nsut it* "(if) in the case of a pesticide not registered in accordance with 7 use IN*. section 3 of this Act and intended for export, the label does not con- tain, in words prominently placed thereon with such conspicuousness FXftA ------- Chapter One FIFBA (as compared with other words, statements, designs, or graphic mat- ter in the labeling) as to render it likely to be noted by the ordinary individual under customary conditions of purchase and use, the following: 'Not Registered for Use in the United States of America'. "(2) A pesticide is misbranded if— "(A) the label does not bear an ingredient statement on that pan of the immediate container (and on the outside container or wrapper of the retail package, if there be one, through which the ingredient statement on the immediate container cannot be clearly read) which is presented or displayed under customary conditions of purchase, except that a pesticide is not misbranded under this subparagrapn if: "(i) the size of form of the immediate container, or the outside container or wrapper of the retail package, makes it impracticable to place the ingredient statement on the part which is presented or displayed under customary conditions of purchase: and "(ii) the ingredient statement appears prominently on another part of the immediate container, or outside container or wrapper, permitted by the Administrator; "(B) the labeling does not contain a statement of the use classification under which the product is registered; "(Q there is not affixed to its container, and to the outside con- tainer or wrapper of the retail package, if there be one, through which the required information on the immediate container cannot be clearly read, a label bearing— "(i) the name and address of the producer, registrant, or per- son for whom produced; "(ii) the name, brand, or trademark under which the pesticide is sold; "(iii) the net weight or measure of the content; Provided. That the Administrator may permit reasonable variations; and "(iv) when required by regulation of the Administrator to ef- fectuate the purposes of this Act, the registration number as- signed to the pesticide under this Act, and the use classification; and "(D) the pesticide contains any substance or substances in quan- tities highly toxic to man, unless the label shall bear, in addition to any other matter required by this Act— "(i) the skull and crossboncs; "(ii) the word 'poison* prominently in red on a background of distinctly contrasting color; and "(iii) a statement of a practical treatment (first aid or otherwise) j in case of poisoning by the pesticide. ! "(r) Nematode.—The term 'nematode' means invertebrate animals of the , phylum nemathelminthes and class nernatoda, that is, unsegmented round worms with elongated, fusiform, or saclike bodies covered with cuticle, and inhabiting soil, water, plants, or plant parts; may also be called nemas or , eelworms. "(s) Person.—The term 'person' means any individual, partnership, association, corporation, or any organized group of persons whether incor- porated or not. "(t) Pest.—The term 'pest* means (1) any insect, rodent, nematode, fungus, weed, or (2) any other form of terrestrial or aquatic plant or animal life or virus, bacteria, or other micro-organism (except viruses, bacteria, or other micro-organisms on or in living man or other living animals) which the Administrator declares to be a pest under section 2S(cXO. ruse i»>. "(u) Pesticide.—The term'pesticide'means (I) any substance or mixture of IM..W-MO: substances intended for preventing, destroying, repelling, or mitigating any ** *"• 7J4 pest, and (2) any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant: Provided, That the term •pesticide' shall not include any article (IXa) that is a 'new animal drug* within the meaning of sec- tion 20l(w) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 32l(w)). •or (b)-that has been determined by the Secretary of Health, Education, and Welfare not to be a new animal drug by a regulation estabHshhig condhioos of use for the article, or (2) that is an animal feed within the meaning of section 20l(x) of such Act (21 U.S.C.321(x)) bearing or containing an article covered by clause (1) of this proviso." 'X v) Plant Regulator.—The term 'plant regulator' means any substance or mixture of substances intended, through physiological action, for accelerating or retarding the rate of growth or rate of maturation, or for otherwise altering the behavior of plants or the produce thereof, but shall not include substances . to the extent that they are intended as plant nutrients, trace demerits, nutri- tional chemicals, plant inoculants. and soil amendments. Abo, the term 'plant Compliance/Enforcement PIT ' Guidance Manual 1963 ------- Chapter One FIFRA P.L. M-3%: P.L. M-3W: TUSCIMc. IMo. IM. 7 USC IM>-4 MMC. regulator' shall not be required to include any of such of those nutrient mix- lures or soil amendments as are commonly known as vitamin-hormone hor- ticultural products, intended for improvement, maintenance, survival, health, and propagation of plants, and as are not for pest destruction and are non- toxic, nonpoisonous in the undiluted packaged concentration. "(w) Producer and Produce.—Tin term 'producer* means the person who manufactures, prepares, compounds, propagates, or processes any pesticide or device or active ingredient used in producing a pesticide. The term 'produce' means to manufacture, prepare, compound, propagate, or process any pesticide or device, or active ingredient used in producing a pesticide. The dilution by individuals of formulated pesticides for their own use and accor- ding to the directions on registered labels shall not of itself result in such in- dividuals being included in the definition of 'producer' for the purposes of this Act." "(a) Protect Health and the Environment.—The terms 'protect health and the environment' and 'protection of health and the environment' mean protec- tion against any unreasonable adverse effects on the environment. "(y) Registrant.—The term 'registrant' means a person who has registered any pesticide pursuant to the provisions of this Act. "(z) Registration.—The term 'registration' includes reregistration. "(aa) Slate.—The term 'Slate* means a State, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Trust Territory of the Pacific Islands, and American Samoa. "(bb) Unreasonable Adverse Effects on the Environment.—The term 'unreasonable adverse effects on the environment* means any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide. "(cc) ***«/.—The term 'weed' means any plant whkhjrows where not "(dd) Establishment.—The term 'establishment' means any place where a pesticide or device or active ingredient used in producing a pesticide is produced, or held, for distribution or sale. "(ee) To Use Any Registered Pesticide in a Manner Inconsistent With Its Libeling.—The term 'to uscany registered pestiseide in a manner inconsistent with its labeling'- means to use any registered pesticide in a manner not permit- ted by the labeling: Provided, That the term shall not include (I) applying a pesticide at any dosage, concentration, or frequency less than that specified on the labeling, (2) applying a pesticide against any target pest not specified on the labeling if the application b to the crop, animal, or site specified on the labeling, unless the Administrator has required that the labeling specifically state that the pesticide may be used only for the pests specified on the labeling after the Administrator has determined that the use of the pesticide against other pests would cause an unreasonable adverse effect on the environment, (3) employing any method of appUcatica not prohifaited by the Jabetmg. or (4) a.pfttiHnV or pfjtiodes with a ffTtjhrrf-when.SBciiJBO>ture is not pro- bibbed by the labeling: Piovided further. That the term also shall not include any use of a pesticide inconfonnance with section 3.18, or 24 of this Act, or any use of a pesticide in a manner that the Administrator determines to be consis- tent with the purposes of this Act: And provided further. That after March 31, 1979. the tern shall not include the use of a pesticide for agricultural or forestry purposes at a dilution less than label dosage unless before or after that date the Administrator issues a regulation or advisory opinion consistent with the study provided for in section 27(b) of the Federal Pesticide Act of 1978, which regulation or advisory opinion specifically requires the use of definite amounts of dilution. "(a) Requirement.— Except as otherwise provided by this Act, no person in any State may distribute, sell, offer for sale, bold for sale, ship, ddrm for shipment, or receive and (having so received) delivery or offer to deliver, to any person any pesticide which is not registered with the Administrator. "(b) Exemptions.— A pesticide which b not registered with the Ad- ministrator may be transferred if— "(1) the transfer is from one registered establishment to another registered establishment °Pe™J*^_^r *** «ame .producer so/dy for i jaisiiirti "(2) the transfer is pursuant to and in accordance with the re- quirements of an experimental use permit. "(c) Procedure for Registration.— (I) Statement required.— Etch applicant for registration of a pesticide shall file with the Administrator a statement which includes— snt i-lo Golda&ce Manual 1983 ------- MFEA "(A) the name and address of the applicant and of any other per- son whose name will appear on the labeling; "(B) the name of (he pesticide; "(C) a complete copy of the labeling of the pesticide, a statement of all claims to be made for it, and any directions for its use; "(D) except as otherwise provided in subsection (c)(2XD) of this section, if requested by the Administrator, a full description of the tests made and the results thereof upon which the claims are based, or alternatively a citation to data that appears in the public literature or that previously hadjwen submitted to the Administrator and that the Administrator may consider in accordance with the following provisions: "(i) with respect to pesticides containing active ingredients that are initially registered under this Act after September 30, 1978, data submitted to support the application for the original registra- tion of the pesticide, or an application for an amendment adding any new use to the registration and that pertains solely to such new use, shall not, without the written permission of the original data submitter, be considered by the Administrator to support an application by another person during a period of ten years follow- ing the date the Administrator first registers the pesticides: Pro- vided, That such permission shall not be required in the case of defensive data; "(ii) except as otherwise provided in subparagraph (DX>) of this paragraph, with respect to data submitted after December 31, 1969, by an applicant or registrant to support an application for registration, experimental use permit, or amendment adding a new use to an existing registration, to support or maintain in ef- fect an existing registration, or for reregistration, the Adminis- trator may, without the permission of the original data submitter, consider any such item of data in support of an application by any other person (hereinafter in this subparagraph referred to as the 'applicant') within the fifteen-year period following the date the data were originally submitted only if the applicant has nude an offer to compensate the original data submitter and submitted such offer to the Administrator accompanied by evidence of delivery to the original data submitter of the offer. The terms and amount of compensation may be fixed by agreement between the original data submitter and the applicant, or, failing such agree- ment, binding arbitration under this subparagraph. If, at the end of ninety days after the date of delivery to the original data sub- mitter of the offer to compensate, the original data submitter and the applicant have neither agreed on the amount and terms of compensation..nor on a procedure for reaching an agreement on the amount and terms of compensation, either person may initiate j binding arbitration proceedings by requesting the Federal Media- i lion and Conciliation Service to appoint an arbitrator from the j roster of arbitrators maintained by such Service. The procedure | and rules of the Service shall be applicable to the selection of such ; arbitrator and to such arbitration proceedings, and the findings and determination of the arbitrator shall be final and conclusive, and no official or court of the United States shall have power or jurisdiction to review any such findings and determination, except . for fraud, misrepresentation, or other misconduct by one of the . panics to the arbitration or the arbitrator where there is a verified [ complaint with supporting affidavits attesting to specific in- * stances of such fraud, misrepresentation, or other misconduct. The parties to the arbitration shall share equally in the payment of the fee and expenses of the arbitrator. If the Administrator deter- mines that an original data submitter has failed to participate in a procedure for reaching an agreement or in an arbitration pro- ceeding as required by this subparagraph, or failed to comply with the terms of an agreement or arbitration decision concerning compensation under this subparagraph, the original data submit- ter shall forfeit the right to compensation for the use of the data in support of the application. Notwithstanding any other provi- sion of this Act, if the Administrator determines that an applicant P.L. 9J.J96: 92Sl«l. 120. (Set note ------- Chapter One FIJKA has failed to participate in a procedure for reaching an agreement or in an arbitration proceeding as required by this subparagraph, or failed to comply with the terms of an agreement or arbitration decision concerning compensation under this subparagraph, the Administrator shall deny the application or cancel the registration of the pesticide in support of which the data were used without further hearing. Before the Administrator takes action under either of the preceding two sentences, the Administrator shall fur- nish to the affected person, by certified mail, notice of intent to take actions and allow fifteen days from the date of deliver)' of the notice for the affected person to respond. If a registration is denied or canceled under this subparagraph, the Administrator may make such order as the Administrator deems appropriate concerning the continued sale and use of existing stocks of such pesticide. Registration action by the Administrator shall not be . delayed pending the fixing of compensation; "(iii) after expiration of any period of exclusive use and any period for which comprmation is required for the use of an item of data under subparagraphs (DXO and (DXn) of this paragraph, the Administrator may consider such hero of data in support of ' an application by any other applicant without the permission of the original data submitter and without an offer having been received to compensate the original data submitter for the use of such item of data; "(E) the complete formula of the pesticide; and "(F) a request that the pesticide be classified for general use, for . .restricted use, or for both. "(2) (A) Data in support pftrgaiiatioa.—The Administrator shall publish guidelines specifying the kinds of information which will be required to support the registration of a pesticide and shall revise such guidelines from time to time. If thereafter he requires any addi- tional kind of information under subparagraph (B) of this paragraph, he shall permit sufficient time for applicants to obtain IISIIH'KU sucn tddkional information. The Administrator, in establishing standards for data requirements for the registration of pesticides with respect to minor uses, shall make such standards commensurate with the anticipated extent of use, pattern of use. and the level and degree of potential exposure of man and the environment to the pesticide. In the development of these standards, the Administrator shall consider the economic factors of potential national volume of use, extent of distribution, and the impact of the cost of meeting the requirements on the incentives for any potential registrant to under- take the development of the required data. Except as provided by 7usci3«o section JO, within JO-days after the Attainiitrator registers a spenkide under this Act he,sball jnakeavailable to tnepufaik the data called for in the registration statement together with such other scientific information as he deems relevant to his decision. "(B) Additional data to support existing registrations.— nSM?n? "® lf lhe Administrator determines that additional data are required to maintain in effect an existing registration of a . pesticide, the Administrator shall notify all existing registrants of the pesticide to which the determination relates and provide a list of such registrants to any interested wrson. "GO Each registrant of such pesticide shall provide evidence pest* within ninety days after receipt of notification that it»taking ap- arc:required ttrnVrrinft jointly, or to ihtrr mtfce tost or developing, such data if they agree and advise the Administrator of their intent within ninety days after notification. Any registrant who agrees to share in the cost of producing the data shall be entitled to examine and rely upon such data in sup- port of maintenance of sod) registration. "(uT) If, at the end of sixty days after advising the Ad- ministrator of their agreement to develop jointly, or share in the cost of developing, data, the registrants have not further agreed on the terms of the data devdopmenl anaogeroent or on a pro- - fledorefw reaching sacbaaveemenl, any of sacoK(istrants faay initiate fciadMKarbiuaUuii |»w«cuHigs %Tequesting the Federal Mediation and Conciliation Service to appoint an arbitrator from the roster of arbitrators maintained by such Service. The pro- cedure and rules of the Service shall be applicable to the selection of such arbitrator and to such arbitration proceedings, and the findings and determination of the arbitrator shall be final and tirarpllance/EnlorceMnt P25 " - Guidance Manual 1583 ------- loapter One FIFRA conclusive, and no official or court of the United States shall have power or jurisdiction to review any such findings and determina- tion, except for fraud, misrepresentation, or other misconduct by one of the parties to the arbitration or the arbitrator where there is a verified complaint with supporting affidavits attesting to specific instances of such fraud, misrepresentation, or other misconduct. All parties to the arbitration shall share equally in the payment of the fee and expenses of the arbitrator. "(iv) Notwithstanding any other provision of this Act, if the Administrator determines that a registrant, within the time re- quired by the Administrator, has failed to take appropriate steps to secure the data required under this subparagraph, to par- ticipate in a procedure for reaching agreement concerning a joint data development arrangement under this subparagraph or in an arbitration proceeding as required by this subparagraph, or to comply with the terms of an agreement or arbitration decision concerning a joint data development arrangement under this sub- paragraph, the Administrator may issue a notice of intent to sus- pend such registrant's registration of the pesticide for which addi- tional data is required. The Administrator may include in the notice of intent to suspend such provisions as the Administrator deems appropriate concerning the continued sale and use of ex» isting stocks of such pesticide. Any suspension proposed under this subparagraph shall become final and effective at the end of thirty days from receipt by the registrant of the notice of intent to suspend, unless during that time a request for hearing is made by a person adversely affected by the notice or the registrant has satisfied the Administrator that the registrant has complied fully with the requirements that served as a basis for the notice of in- tent to suspend. If a hearing is requested, a hearing shall be con- ducted under section 6(d) of this Act: Provided, That the only matters for resolution at that hearing shall be whether the registrant has failed to take the action that served as the basis for the notice of intent to suspend the registration of the pesticide for which additional data is required, and whether the Ad- ministrator's determination with respect to the disposition of ex- isting stocks is consistent with this Act. If a hearing is held, a deci- sion after completion of such hearing shall be final. Notwith- standing any other provision of this Act, a hearing shall be held and a determination made within seventy-five days after receipt of a request for such hearing. Any registration suspended under this subparagraph shall be reinstated by the Administrator if the Ad- ministrator determines that the registrant has compiled fully with the requirements that served as a basis for the suspension of the registration. "(v) Any data submitted under this subparagraph shall be subject to the provisions of subsection (cXIXD) of this section. Whenever such data are sub- mitted jointly by two or more registrants, an agent shall be agreed on at the time of the joint submission to handle any subsequent data compensation mat- ters for the joint submitters of such data.". "(Q Simplified procedures.—Within nine months after date of enactment of (his subparagraph, the Administrator shall by regula- tion, prescribe simplified procedures for the registration of pesticides, whkh shall include the provisions of subparagraph (D) of this paragraph. "(D) Exemption.—No applicant for registration of a pesticide who proposes to purchase a registered pesticide from another pro- ducer in order to formulate such purchased pesticide into an end-use product shall be required to— "(i) submit or cite data pertaining to the safety of such pur- chased product; or "("') offer to pay reasonable compensation otherwise required by paragraph (1KD) of this subsection for the use of any such data.". "(3) Tune for acting with respect to application.—-The Ad- ministrator shall review the data after receipt of the application and shall, as expeditiousiy as possible, either register the pesticide in accor- dance with paragraph (5), or notify the applicant of his determination that it does not comply with the provisions of the Act in accordance with paragraph (6). "(4) Notice of application.—The Administrator shall publish in the Federal Register, promptly after receipt of the statement and other data required pursuant to paragraphs (1) and (2), a notice of each application for registration of any pesticide if it contains any new active ingredient Payment of arbitrator. Hearing. T USC IJ6d P.L. »J.J*6; n Stal. U4. P.L. t»-J»6: n St*. W« Federal *<*««. FIFRA Goapllance/Eaforceaent" 1-21 Guidance Manual 1983 ------- Chapter One P.L. W-M6: n SMI. 115 7 USC I3*». PuMieaimn in Federal fttgbK I'.I •»«•>•*: «: Mm «:.«. or if it would entail a changed use pattern. The notice shall provide for a period of 30 days in which any Federal agency or any other interested person, may comment. "(5) Approval of registration. — The Administrator shall register a pesticide if he determines that, when considered with any restrictions imposed under subsection (d) — "(A) its composition is such as to warrant the proposed claims for it; "(B) its labeling and other material required to be submitted com- ply with the requirements of this Act; "(C) it will perform its intended function without unreasonable adverse effects on the environment; and "(D) when used in accordance with widespread and commonly recognized practice it will not generally cause unreasonable adverse effects on the environment. The Administrator shall not make any lack of essentiality a criterion for denying registration of any pesticide. Where two pesticides meet the re- quirements of this paragraph, one should not be registered in preference to the other. In considering an application for the registration of a pesticide, the Administrator may waive data requirements pertaining to efficacy, in which event the Administrator may register the pesticide without determining that the pesticide's composition is such as to war- rant proposed claims of efficacy. If a pesticide is found to be efficacious by any State under section 24(c) of this Act, a presumption is established that the Administrator shall waive data requirements pertaining to ef- ficacy for use of the pesticide in such State. "46) *Deniat of registration.— 11 .the Administrator determines that .the requirements of .paragraph .(5) for registration are not satisfied, he shall notify the applicant for registration of his determination and of his reasons (including the factual basis) therefor, and that, unless the appli- cant corrects the conditions and notifies the Administrator thereof dur- ing the 30-day period beginning with the day after the date on which the applicant receives the notice, the Administrator may refuse to register the pesticide. Whenever the Administrator refuses to register a pesticide, he shall notify the applicant of his decision and of his reasons (including the factual basis) therefor. The Administrator shall promptly publish in the Federal Register notice of such denial of registration and the reasons therefor. Upon such notification, the applicant for registra- tion or other interested person with the concurrence of the applicant shall have the same remedies as provided for in section 6. "(1) Registration under special circumstances. — Notwithstanding the provisions of subsection (cMS) of this section — "{A) The Administrator may conditionally register or amend the regismiioo of a.pestkide if .the Administrator determines thai (i) the pcsiiridr and .proposed use are identical or substantially similar to any currently registered pesticide and use thereof, or differ only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment, and (ii) approving the registra- tion or amendment in the manner proposed by the applicant would not significantly increase the risk of any unreasonable adverse effect on the environment. An applicant seeking conditional registration or amended registration under this subparagraph shall submit such data as would be required to obtain registration of a similar pesticide under subsection (cX5) of this section: Provided. That, if the appli- cant is unable to submit an item of data because it has not yet been - ?vff nrraied. the Administrator may *«jJneT..o*«mend the jegistjatioc of 4he pesticide mufcraiKhcond^^ of such data not later than the time such data are required to be sub- mitted with respect to similar pesticides already registered under this Act. "(B) The Administrator may conditionally amend the registration of a pesticide to permit additional uses of such pesticide notwith- standing that data concerning the pesticide may be insufficient to support an unconditional amendment, if the Administrator deter- mines that (i) the applicant has submitted satisfactory data pertaining to the proposed additional use. and (U) amending the registration in r piDpBad'i»y*lK.------- Chapter One FIFRA dietary exposure enumerated in regulations isued under this Act, and during the pendency of any risk-benefit evaluation initiated by such notice, if (i) the additional use of such pesticide involves a major food or feed crop, or (ii) the additional use of such pesticide involves a minor food or feed crop and the Administrator determines, with the concurrence of the Secretary of Agriculture, there is available an effective alternative pesticide that does not meet or exceed such risk criteria. An applicant seeking amended registration under this sub- paragraph shall submit such data as would be tequired to obtain registration of a similar pesticide under subsection (c)(5) of this sec- tion: Provided, That, if the applicant is unable to submit an item of data (other than data pertaining to the proposed additional use) because it has not yet been generated, the Administrator may amend the registration under such conditions as will require the submission of such data not later than the time such data are required to be sub- mitted with respect to similar pesticides already registered under this Act. "(C) The Administrator may conditionally register a pesticide containing an active ingredient not contained in any currently registered pesticide for a period reasonably sufficient for the genera- tion and submission of required data (which are lacking because a period reasonably sufficient for generation of the data has not elapsed since the Administrator first imposed the data requirement) on the condition that by the end of such period the Administrator receives such data and the data do not meet or exceed risk criteria enumerated in regulations issued under this Act, and on such other conditions as the Administrator may prescribe: Provided, That a conditional registration under this subparagraph shall be granted only if the Administrator determines that use of the pesticide during such period will not cause any unreasonable adverse effect on the en- vironment, and that use of the pesticide is, in the public interest. "(8) Interim administrative review. —Notwithstanding any other pro- vision of this Act, the Administrator may not initiate a public interim administrative review process to develop a risk-benefit evaluation of the ingredients of a pesticide or any of its uses prior to initiating a formal action to cancel, suspend, or deny registration of such pesticide, re- quired under this Act, unless such interim administrative process is based on a validated test or other significant evidence raising prudent concerns of unreasonable adverse risk to man or to the environment. Notice of the definition of the terms 'validated test' and 'other signifi- cant evidence' as used herein shall be published by the Administrator in the Federal Register." "(d) Classification of Pesticides.— "(1) Classification-for general use, restricted use. or both.— "(A) As a part of the registration of a pesticide the Administrator shall classify it as being for general use or for restricted use. provided that if the Administrator determines that some of the uses for which the pesticide is registered should be for general use and that other uses for which it is registered should be for restricted use, he shall classify it for both general use and restricted use. Pesticide uses may be classified by regulation on the initial classification, and registered pesticides may be classified prior to reregistration. If some of the uses of the pesticide are classified for general use and other uses are classified for restricted use, the directions relating to its general uses shall be clearly separated and distinguished from those directions relating to its restricted uses: Provided, however. That the Ad- ministrator may require that its packaging and labeling for restricted uses shall be clearly distinguishable from its packaging and labeling for general uses. "(B) If the Administrator determines that the pesticide, when ap- plied in accordance with its directions for use, warnings and cautions and for the uses for which it is registered, or for one or more of such uses, or in accordance with a widespread and commonly frrogniied practice, will not generally cause unreasonable advene effects on the environment, he will classify the pesticide, or the particular use or uses of the pesticide to which the determination applies, for general use. "(C) If the Administrator determines that the pesticide, when ap- plied in accordance with its directions for use, warnings and cautions and for the uses for which it is registered, or for one or more of such uses, or in accordance with a widespread and commonly recognized practice, may generally cause, without additional regulatory restric- tions, unreasonable adverse effects on the environment, including P.L. «-»6. 92 Sill. 126. Notice of Definitions. Public*! ion in Feorrtl Rrjuirr P.L. 9i-i9t. « Sl»l. 126. FIFRA Compliance/EnforceBenT Guidance" 1553 ------- Chapter One FIFE* injury to.the applicator, he shall classify the pesticide, or the par- ticular use or uses to which the determination applies, Tor restricted use: "(i) If the Administrator classifies a pesticide, or one or more uses of such pesticide, for restricted use because of a determina- tion that the acute dermal or inhalation toxicily of the pesticide presents a hazard to the applicator or other persons, the pesticide shall be applied for any use to which the restricted classification applies only by or under the direct supervision of a certified ap- plicator. "(ii) If the Administrator classifies a pesticide, or one or more uses of such pesticide, for restricted use because of a determina- tion that its use without additional regulatory restriction may cause unreasonable adverse effects on the environment, the pesticide shall be applied for any use to which the determination applies only by or under the direct supervision of a certified ap- plicator, or subject to such other restrictions as the Administrator may provide by regulation. Any such regulation shall be revtewabie in the appropriate court of appeals upon petition of a person adversely affected filed within 60 days of the publication of the regulation in final form. ..„ ,r "(2) Change in classification.—If the Administrator determines that i?.Mir a change in the classification of any use of a pesticide from general use to restricted use is necessary to prevent unreasonable adverse effects on the environment, he shall notify the registrant of such pesticide of such determination at least forty-five days before making the change and shall publish the proposed change in the Federal Register. The registrant, or other interested person with the concurrence of the .v_; registrant,may seek relief from such determination under section 6(b). PI «?-.««.: "(3) Change in ftaaificarioH from restricted me to general use. —The *J*"" *" registrant of any pesticide with one or more uses classified for restricted use may petition the Administrator to change any such classification from restricted to general use. Such petition shall set out the basis for the registrant's position that restricted use classification is unnecessary because classification of the pesticide for general use would not cause unreasonable adverse effects on the environment. The Administrator, within sixty days after receiving such petition, shall notify the registrant whether the petition has been granted or denied. Any denial shall con- tain an explanation therefor and any such denial shall be subject to 7 UM i.ww, judicial review under section 16 of this Act. "(e) Products With Same Formulation and Claims.—Products which have the same formulation, are manufactured by the same person, the labeling of which contains the same claims, and the labels of which bear a designation identifying the product as the same pesticide may be registered as a single pesticide; and additional names and labels shall be added to the registration by '".supplemental statements. "------- Chapter One FIFRA "SEC. 4. USE OF RESTRICTED USE PESTICIDES; CERTIFIED AP- PLICATORS. "(a) Certification Procedure.— "(1) Federal certification.—In any Stale for which a State plan for applicator certification has not been approved by the Administrator, the Administrator, in consultation with the Governor of such State, shall conduct a program for the certification of applicators of pesticides: Pro- vided. That such program shall conform to the requirements imposed upon the States under the provisions of subsection (aM2) of this section and shall not require private applicators to take any examination to establish competency in the use of pesticides. Prior to the implementa- tion of the program, the Administrator shall publish in the Federal Register for review and comment a summary of the Federal plan for ap- plicator certification and shall make generally available within the State copies of the plan. The Administrator shall hold public hearings at one or more locations within the State if so requested by the Governor of such State during the thirty days following publication of the Federal Register notice inviting comment on the Federal plan. The hearings shall be held within thirty days following receipt of the request from the Governor. In any Slate in which the Administrator conducts a certifica- tion program, the Administrator may require any person engaging in the commercial application, sale, offering for sale, holding for sale, or distribution of any pesticide one or more uses of which have been classified for restricted use to maintain such records and submit such reports concerning the commercial application, sale, or distribution of such pesticide as the Administrator may by regulation prescribe. Subject to paragraph (2), the Administrator shall prescribe standards for the certification of applicators of pesticides. Such standards shall provide that to be certified, an individual must be determined to be competent with respect to the use and handling of pesticides, or to the use and handling of the pesticide or class of pesticides covered by such in- dividual's certification: Provided, however. That the certification stan- dard for a private applicator shall, under a State plan submitted for ap- proval, be deemed. fulfilled by his completing a certification form. The Administrator shall further assure that such form contains ade- quate information and affirmations to carry out the intent of this Act, and may include in the form an affirmation that the private applicator has completed a training program approved by the Administrator so long as the program does not require the private applicator to take, pur- suant to requirement prescribed by the Administrator, any examination to establish competency in the use of the pestiscide. The Administrator may require any pesticide dealer participating in a certification program to be licensed under a State licensing program approved by him. "(2) Stale certification.—If any State, at any time, desires to certify applicators of pesticides, the Governor of such State shall submit a State plan for such purpose. The Administrator shall approve the plan sub- mitted by any State, or any modification thereof, if such plan in his judgment— 4'(A) designates a State agency as the agency responsible for ad- ministering the plan throughout the State; "(B) contains satisfactory assurances that such agency has or will have the legal authority and qualified personnel necessary to carry out the plan; "(Q gives satisfactory assurances that the State will devote ade- quate funds to the administration of the plan; "(D) provides that the State agency will make such reports to the Administrator in such form and containing such information as the Administrator may from time to time require; and "(E) contains satisfactory assurances that State standards for the certification of applicators of pesticides conform with those stan- dards prescribed by the Administrator under paragraph (I). Any State certification program under this section shall be maintained in accordance with the State plan approved under this section. "(b) State Plans.—If the Administrator rejects a plan submitted under this paragraph, he shall afford the State submitting the plan due notice and oppor- tunity for hearing before so doing. If the Administrator approves a plan sub- mitted under this paragraph, then such State shall certify applicators of pesticides with respect to such State. Whenever the Administrator determines that a State is not administering the certification program in accordance with the plan approved under this section, he shall so notify the State and provide for a hearing at the request of the State, and, if appropriate corrective action is i rsr i.v* Public Standards P.L. »4.HO: If Siai. 733. PIPE! fluidance Manual 1983 ------- wnapter One FIFRA P.I. V4.I4D. 14 Sill '?- 7 USC IJAu noi taken within a reasonable lime, not to exceed ninety days, the Ad- ministrator shall withdraw approval of such plan. "(c) Instruction in Integrated Pest Management Techniques.—Standards prescribed by the Administrator for the certification of applicators of pesticides under subsection (a), and the State plans submitted to the Ad- ministrator under subsection (a) and (b). shall include provisions for making instructional materials concerning integrated pest management techniques available to individuals at their request in accordance with the provisions of section 23(c) of this Act, but such plans may not require that any individual receive instruction concerning such techniques or be shown to be competent with respect to the use of such techniques. The Administrator and States im- plementing such plans shall provide that all interested individuals are notified of the availability of such instructional materials." P.L. W-3»6: « s»i. at. 7 USC IM>. 7 USC 13*. 7 USC 1Mb. P.L. ««-l«h WSul. 754. "SEC. 5. EXPERIMENTAL USE PERMITS. . "(a) Jssuance.-~Aj)y person may .apply to the Administrator for an ex- perimental use permit for a pesticide. The Administrator shall review the ap- plication. After completion of the review, but not later than one hundred and twenty days after receipt of the application and all required supporting data, the Administrator shall either issue the permit or notify the applicant of the Administrator's determination not to issue the permit and the reasons therefor. The applicant may correct the application or request a waiver of the conditions for such permit within thirty days of receipt by the applicant of such notification. The Administrator may issue an experimental use permit only if the Administrator determines that the applicant needs such permit in order to accumulate information necessary to register a pesticide under section 3 of this Act. An application/or .an experimeaiaJ,use permit may.be filed at any time. "(b) Temporary Tolerance Level.—If the Administrator determines that the use of a pesticide may reasonably be expected to result in any residue on or in food or feed, he may establish a temporary tolerance level for the residue of the pesticide before issuing the experimental use permit. "(c) Use Under Permit.—Use of a pesticide under an experimental use per- mit shall be under the supervision of the Adminstrator, and shall be subject to such terms and conditions and be for such period of time as the Administrator may prescribe in the permit. "(d) Studies.—When any experimental use permit is issued for a pesticide containing any chemical or combination of chemicals which has not been in- cluded in any previously registered pesticide, the Administrator may specify that studies be conducted to detect whether the use of the pesticide under the permit may cause unreasonable adverse effects on the environment. All results of such studies shall be reported to the Administrator before such pesticide may be registered under section 3. "(e) /(evocation.—The Administrator may revoke any experimental use permit, at any time, if he finds that its terms or conditions are hang violated, or that its terms and conditions are inadequate to avoid unreasonable adverse effects on the environment. "(f) State Issuance of Permits.— Notwithstanding the foregoing provisions of this section, the Adminsitrator shall.under such terms and conditions as he may by regulations prescribe, authorize any State to issue an experimental use permit for a pesticide. All provisions of section 4 relating to State plans shall apply with equal force to a State plan for the issuance of experimental use permits under this section. "(g) Exemption for Agricultural Research Agencies.—Notwithstanding the foregoing provisions of this section, the Administrator nay issue an ex- perimental use permit for a pesticide to joy public or/private agrioibural *gse»*caaiency «f>«if»ffan of «ny«Bticide at the end oft h« five-year period which begins on the date of its registration (or at the end of any rive-year period thereafter) unless the registrant, or other interested person with the concurrence of the registrant, before the end of such period, requests in accordance with 1-Zo Guidance Manual 1983 ------- Chapter One FIFRA regulations prescribed by ihe Administrator that the registration be con- tinued in effect: Provided, That the Administrator may permit the con- tinued sale and use of existing stocks of a pesticide whose registration is canceled under this subsection or subsection (b) to such extent, under such conditions, and for such uses as he may specify if he determines that such sale or use is not inconsistent with the purposes of this Act and will not have unreasonable adverse effects on the environment. The Ad- ministrator shall publish in the Federal Register, at least 30 days prior to the expiration of such five-year period, notice that the registration will be canceled if the registrant or other interested person with the concur- rence of the registrant does not request that the registration be con- tinued in effect. "(2) Information.— If at any time after the registration of a pesticide the registrant has additional factual information regarding unreasonable adverse effects on the environment of the pesticide, he shaJl submit such information to the Administrator. "(b) Cancellation and Chance in Classification.—If it appears to the Ad- ministrator that a pesticide or its labeling or other material required to be sub- mitted does not comply with the provisions of this Act or when used in accor- dance with widespread and commonly recognized practice, generally causes unreasonable adverse effects on the environment, the Administrator may issue a notice of his intent either— "(I) to cancel its registration or to change its classification together with the reasons (including the factual basis) for his action, or "(2) to hold a hearing to determine whether or not its registration should be canceled or its classification changed. Such notice shall be sent to the registrant and made public. In determining whether to issue any such notice, the Administrator shall include among those factors to be taken into account the impact of the action proposed in such notice on production and prices of agricultural commodities, retail food prices, and otherwise on the agricultural economy. At least 60 days prior to sending such notice to the registrant or making public such notice, whichever occurs first, the Administrator shall provide the Secretary of Agriculture with a copy of such notice and an analysis of such impact on the agricultural economy. If the Secretary comments in writing to the Administrator regarding the notice and analysis within 30 days after receiving them, the Administrator shall publish in the Federal Register (with the notice) the comments of the Secretary and the response of the Administrator with regard to the Secretary's comments. If the Secretary does not comment in writing to the Ad- ministrator regarding the notice and analysts within 30 days after receiving them, the Administrator may notify the registrant and make public the notice at any time after such 30-day period notwithstanding the foregoing 60-day time requirement. The time requirements imposed by the preceding 3 sentences may be waived or modified to the extent agreed upon by the Ad- ministrator and the Secretary. Notwithstanding any other provision of this subsection (b) and section 25(d), in the event that the Administrator deter- mines that suspension of a pesticide registration is necessary to prevent an im- minent hazard to human health, then upon such a finding the Administrator may waive the requirement of notice to and consultation with the Secretary of Agriculture pursuant to subsection (b) and of submission to the Scientific Ad- visory Panel pursuant to section 25(d) and proceed in accordance with subsec- tion (c). The proposed action shall become final and effective at the end of 30 days from receipt by the registrant, or publication, of a notice issued under paragraph (1), whichever occurs later, unless within (hat time either (i) the registrant makes the necessary corrections, if possible, or (u) a request for a hearing is made by a person adversely affected by the notice. In the event a hearing is held pursuant to such a request or to the Administrator's determina- tion under paragraph (2), a decision pertaining to registration or classification issued after completion of such hearing shall be final. In taking any final action under this subsection, ihe Administrator shall consider restricting a pesticide's use or uses as an alternative to cancellation and shall fully explain the reasons for these restrictions, and shall include among those factors to be taken into account the impact of such final action on production and prices of agricultural commodities, retail food prices, and otherwise on (he agricultural economy, and he shall publish in die Federal Register an analysis of such impact. "(c) Suspension.— "(1) Order.—If the Administrator determines that action is necessary to prevent an imminent hazard during the time required for cancellation or change in classification proceedings he may, by order, suspend the registration of the pesticide immediately. No order of suspension may be issued unless the Administrator has issued or at the same time issues notice of his intention to cancel the registration or change the classifica- tion of the pesticide. Publication in Federal Refiner. Hearing P.L. 94-140; WSlai 751. Publication in . Federal RettMn. C- IJn. P.L. «5-I*6: RSut.ta. P.L. M.I40-. •> SMI. 751. FlFJtA Cbapllance/lin±orce»enF Guidance Manual 1983 ------- Chapter One FIFRA (OSui. )«l: II SKI. M. 5 USC 5)1. 7 USC IMn. Subponu. IlUSCapp. Except as provided in paragraph (3), the Administration shall notify the registrant prior to issuing any suspension order. Such notice shall in- clude findings pertaining to the question of 'imminent hazard'. The registrant shall then have an opportunity, in accordance with the provi- sions of paragraph (2), for an expedited hearing before the Agency on the question of whether an imminent hazard exists. "(2) Expedite hearing. — If no request for a hearing is submitted to the Agency within five days of the registrant's receipt of the notification provided for by paragraph (1). the suspension order may be issued and shall take effect and shall not be reviewable by a court. If a hearing is re- quested, it shall commence within five days of the receipt of the request for such hearing unless the registrant and the Agency agree that it shall commence at a later time.- The hearing shall be held in accordance with the provisions of subchapter II of title 5, of the United States Code, ex- cept that the presiding officer need not be a certified hearing examiner. The presiding officer shall have ten days from the conclusion of the presentation of evidence to submit recommended findings and conclu- sions to the Administrator, who shall then have seven days to render a final order on the issue of suspension. "(3) Emergency order. — Whenever the Administrator determines that an emergency exists that does not permit him to hold a hearing before suspending, he may issue a suspension order in advance of notification to the registrant. In that case, paragraph (2) shall apply ex- cept that (i) the order of suspension shall be in effect pending the ex- peditious-completion of the remedies provided by that paragraph and the issuance of a, final order/on suspension, and (ii) no party other than the registrant and the Agency shall participate except that any person adversely affected may file briefs within the time allotted by the Agen- cy's rules. Any person so filing briefs shall be considered a party to such proceeding for the purpose of section 16(b). "(4) Judicial review. — A final order on the question of suspension following a hearing shall be reviewable in accordance with Section 16 of this Act, notwithstanding the fact that any related cancellation pro- ceedings have not been completed. Petitions to review orders on the issue of suspension shall be advanced on the docket of the courts of ap- peals. Any order of suspension entered prior to a hearing before the Ad- ministrator shall be subject to immediate review in an action by the registrant or other interested person with the concurrence of the registrant in an appropriate district court, solely to determine whether the order of suspension was arbitrary, capricious or an abuse of discre- tion, or whether the order was issued in accordance with the procedures veslaWished by iaw. Tire effect of any order of theowirt will be only to stay the effectiveness of the suspension order, pending the Ad- ministrator's final decision with respect to cancellation or change in classification. This action may be maintained simultaneously with any administrative review proceeding under this section. The commence- ment of proceedings under this paragraph shall not operate as a stay of order, unless ordered by the court. "(d) Public Hearings and Scientific Review. — In the event a hearing is re- quested pursuant to subsection (b) or determined upon by the Administrator pursuant to subsection (b), such hearing shall be held after due notice for the purpose of receiving evidence relevant and material to the issues raised by the objections filed by the applicant or other interested parties, or to the issues . stated by jlne ^Adnumstcatar, *f «he tenures jodted % -the Adnrinistrator other .than fey 'the filing 'of objections. Upon a showing >of retevmnce -and reasonable scope of evidence sought by any party to a public hearing, the Hearing Examiner shall issue a subpoena to compel testimony or production of documents from any person. The Hearing Examiner shall be guided by the principles of the Federal Rules of Civfl Procedure in making any order for the protection of the witness or the content of documents produced and shall _ order the payment of reasonable fees and expenses as a condition to requiring • testimony of the witness. On contest, the subpoena may be enforced by an ap- propriate United States district court in accordance with the principles stated herein. Upon the request of any. party to a public hearing aod when in the 'y •or^dciiiable, ;GK Heuim Ex- c^ « tfosed refer to* Commit- Report. < tee of the National Academy of Sciences the relevant questions of scientific fact involved in the public hearing. No member of any committee of the Na- tional Academy of Sciences established to carry out the functions of this sec- tion shall have a financial or other conflict of interest with respect to any mat- ter considered by such committee. The Committee of the National Academy of Sciences shall report in writing to the Hearing Examiner within 60 days after such referral on these questions of scientific fact. The report shall be made FIFRA Compliance/EnforceaenT Guldance Manual ------- Chapter One FIFRA public and shall be considered as part of the hearing record. The Ad- ministrator shall enter into appropriate arrangements with the National Academy of Sciences to assure an objective and competent scientific review of the questions presented to Committees of the Academy and to provide such other scientific advisory services as may be required by the Administrator for carrying out the purposes of this Act. As soon as practicable after completion of the hearing (including the report of the Academy) but not later than 90 days thereafter, the Administrator shall evaluate the data and reports before him and issue an order either revoking his notice of intention issued pursuant to this section, or shall issue an order either canceling the registration, changing the classification, denying the registration, or requiring modification of the labeling or packaging of the article. Such order shall be based only on substan- tial evidence of record of such hearing and shall set forth detailed findings of fact upon which the order is based. "(e) Conditional Registration.— "(1) The Administrator shall issue a notice of intent to cancel a registration issued under section 3(c)(7) of this Act if (A) the Ad- ministrator, at any time during the period provided for satisfaction of any condition imposed, determines that the registrant has failed to in- itiate and pursue appropriate action toward fulfilling any condition im- posed, or (B) at the end of the period provided for satisfaction of any condition imposed, that condition has not been met: Provided, That the Administrator may permit the continued sale and use of existing stocks of a pesticide whose conditional registration has been canceled under this subsection to such extent, under such conditions, and for such uses as the Administrator may specify if the Administrator determines that _ such sale or use is not inconsistent with the purposes of this Act and will not have unreasonable adverse effects on the environment. "(2) A cancellation proposed under this subsection shall become final and effective at the end of thirty days from receipt by the registrant of the notice of intent to cancel unless during that time a request for hearing is made by a person adversely affected by the notice. If a hear- ing is requested, a hearing shall be conducted under subsection (d) of this section: Provided, That the only matters for resolution at that hear- ing shall be whether the registrant has initiated and pursued appropriate action to comply with the condition or conditions within the time pro- vided or whether the condition or conditions have been satisfied within the time provided, and whether the Administrator's determination with respect to the disposition of existing stocks is consistent with this Act. A decision after completion of such hearing shall be final. Notwithstand- ing any other provision of this section, a hearing shall be held and a determination made within seventy-five days after receipt of a request for such hearing. "(0 Judicial Review.—Final orders of the Administrator under this section shall be subject to judicial review pursuant to section 16. P.L. 95-3%; 9: Slat. 828. Notice. ^ USC I36a 7 USC IJ6n. "SEC. 7. REGISTRATION OF ESTABLISHMENTS. "(a) Requirement.—No person shall produce any pesticide subject to this Act or active ingredient used in producing a pesticide subject to this Act in any State unless the establishment in which it is produced is registered with the Ad- ministrator. The application for registration of any establishment shall include the name and address of the establishment and of the producer who operates such establishment. "(b) Registration.—Whenever the Administrator receives an application under subsection (a), he shall register the establishment and assign it an establishment number. "(c) Information Required.— "(1) Any producer operating an establishment registered under this section shall inform the Administrator within 30 days After it is registered of the types and amounts of pesticides and. if applicable, ac- tive ingredients used in producing pesticides— "(A) which he is currently producing; "(B) which he has produced during the past year; and "(C) which he has sold or distributed during the past year. The information required by this paragraph shall be kept current and submitted to the Administrator annually as required under such regula- tions as the Administrator may prescribe. "(2) Any such producer shall, upon the request of the Administrator for the purpose of issuing a stop sale order pursuant to section 13, in- form him of the name and address of any recipient of any pesticide pro- duced in any registered establishment which he operates. 7 USC 134. P.L. 95-3%: 92 SIM. 829. 92 Sut. 129. FIFRA Compliance/Enforcement" Guidance Manual 1983 1-29 ------- Chapter One FIFRA "(d) Confidential Records and Information.—Any information submitted 92 sut. i» to the Administrator pursuant to subsection (c) other than the names of the pesticides or active ingredients used in producing pesticides produced, sold, or distributed at an establishment shall be considered confidential and shall be • use iJ*»> subject to the provisions of section 10. 7 USC IJW Rejulaitom. P.L. 95-396: 92 Sill. 129. "SEC. 8. BOOKS AND RECORDS. "(a) Requirements.—The Administrator may prescribe regulations requir- ing producers to maintain such records with respect to their operations and the pesticides and devices produced as he determines are necessary for the effec- tive enforcement of this Act. No records required under this subsection shall extend to financial data, sales data other than shipment data, pricing data, personnel data, .and research data (other than data relating to registered pesti- cides or to.a pesticide for which an application for registration has been filed). "(b) Inspection.—For the purposes of enforcing the provisions of this Act, any producer, distributor, carrier, dealer, or any other person who sells or of- fers for sale, delivers or offers for delivery any pesticide or device subject to this Act, shall, upon request of any officer or employee of the Environmental Protection Agency or of any State or political subdivision, duly designated by the Administrator, furnish or permit such person at all reasonable times to have access to, and to copy: (I) all records showing the delivery, movement, or holding of such pesticide or device, including the quantity, the date of ship- ment and receipt, and the name of the consignor and consignee; or (2) in the event of the inability of any person to produce records containing such infor- mation, ail other records and information relating to such delivery, move- ment, or holding of ihe pesticide or.device. Any inspection with respect to any records and information referred to in this subsection shall not extend to financial data, sales data other than shipment data, pricing data, personnel data, and research data (other than data relating to registered pesticides or to a pesticide for which an application for registration has been filed). Before undertaking an inspection under this subsection, the officer or employee must present to the owner, operator, or agent in charge of the establishment or other place where pesticides or devices are held for distribu- tion or sale, appropriate credentials and a written statement as to the reason for ihe inspection, including a statement as to whether a violation of the law is suspected. If no violation is suspected, an alternate and sufficient reason shall be given in writing. Each such inspection shall be commenced and completed with reasonable promptness. 1 USC I3*f "SEC. -9. INSPECTION OF ESTABLISHMENTS. ETC. "(a) In General.—for purposes of enforcing the provisions of this Act, of- ficers or employees duly designated by the Administrator are authorized to enter at reasonable times, any establishment or other place where pesticides or devices are held for distribution or sale for the purpose of inspecting and ob- taining samples of any pesticides or devices, packaged, labeled , and released for shipment, and samples of any containers or labeling for such pesticides or devices. Before undertaking such inspection, the officers or employees must present to the owner, operator, or agent in charge of the establishment or other place where pesticides or devices are held for distribution or sale, ap- propriate xrcdenmis and a wnttensiateraem as to *he,reason for the inspec- Jion, irtrlndmg aaarcmgm as lowt>ethgr,» violation of theiaw is suspected. If no violation is suspected, an alternate and sufficient reason shall be given in writing. Each such inspection shall be commenced and completed with reasonable promptness. If the officer or employee obtains any samples, prior to leaving the premises, he shall give to the owner, operator, or agent in charge a receipt describing the samples obtained and, if requested, a portion of each such sample equal in volume or weight to the portion retained. If an analysis is made of such samples, a copy of the results of such analysis shall be furnished promptly to the owner, operator, or agent in charge. "(b) Warrants.—For purposes of enforcing the provisions of Ibis Act and apofxasnowingtoan officer or court of.competent jurisdiction that there is •• Tqcott *o Witvr tharthe •provhiom of ttm Act ^iBve^becn violated, 'officers or employees duly designated by the Administrator are empowered to obtain and to execute warrants authorizing— "(1) entry for Ihe purpose of this section; "(2) inspection and reproduction of all records showing the quantity, date of shipment, and the name of consignor and consignee of any FLrKA Goapllance/Knxorcenent 1-30 Guidance Manual 1983 ------- Chapter One FLFRA pesticide or device found in the establishment which is adulterated, misbranded, not registered (in the case of a pesticide) or otherwise in violation of this Act and in the event of the inability of any person to produce records containing such information, all other records and in- formation relating to such delivery, movement, or holding of the pesticide or device; and "(3) the seizure of any pesticide or device which is in violation of this Act. "(c) Enforcement.— "(I) Certification of facts to attorney general.—The examination of pesticides or devices shall be made in the Environmental Protection Agency or elsewhere as the Administrator may designate for the purpose of determining from such examinations whether they comply with the requirements of this Act. If il shall appear from any such examination that they fail to comply with the requirements of this Act, the Ad- ministrator shall cause notice to be given to the person against whom criminal or civil proceedings are contemplated. Any person so notified shall be given an opportunity to present his views, either orally or in writing, with regard to such contemplated proceedings, and if in the opi- nion of the Administrator it appears that the provisions of (his Act have been violated by such person, then the Administrator shall certify (he facts to the Attorney General, with a copy of the results of the analysis or the examination of such pesticide for the institution of a criminal pro- ceeding pursuant to section I4(b) or a civil proceeding under section I4(a), when (he Administrator determines that such action will be suffi- cient (o effectuate the purposes of this Act. "(2) Notice not required.—The notice of contemplated proceedings and opportunity to present views set forth in this subsection are not prerequisites to the institution of any proceeding by the Attorney General. "(3) Warning notices.— Nothing in this Act shall be construed as re- quiring the Administrator to institute proceedings for prosecution of minor violations of this Act whenever he believes that (he public interest will be adequately served by a suitable written notice of warning. 7 USC IJ6I. "SEC. 10. PROTECTION OF TRADE SECRETS AND OTHER INFOR- MATION. "(a) In General.— In submitting data required by this Act, the applicant may (I) clearly mark any portions thereof which in his opinion are trade secrets or commercial or financial information and (2) submit such marked materials separately from other material required to be submitted under this Act. "(b) Disclosure.—Notwithstanding any other provision of this Act, and subject to (he limitations in subsections (d) and (e) of this section the Ad- ministrator shall not make public information which in his judgment contains or relates to trade secrets or commercial or financial information obtained from a person and privileged or confidential, except that, when necessary to carry out the provisions of this Act, information relating to formulas of pro- ducts acquired by authorization of this Act may be revealed to any Federal agency consulted and may be revealed at a public hearing or in findings of fact issued by the Administrator. "(c) Disputes.—If the Administrator proposes to release for inspection in- formation which (he applicant or registrant believes to be protected from disclosure under subsection (b), he shall notify the applicant or registrant, in writing, by certified mail. The Administrator shall not thereafter make available for inspection such data until thirty days after receipt of the notice by the applicant or registrant. During this period, the applicant or registrant may institute an action in an appropriate district court for a declaratory judgment as to whether such information is subject (o protection under subsection (b). "(d) Limitations.— "(1) All information concerning the objectives, methodology, results, or significance of any test or experiment performed on or with a registered or previously registered pesticide or its separate ingredients, impurities, or degradation products, and any information concerning the cffecis of such pesticide on any organism or (he behavior of such pesticide in (he environment, including, bui not limited to, data on safe- ly to fish and wildlife, humans and other mammals, plants, animals, and soil, and studies on persistence, Iranslocation and fate in the en- vironment, and metabolism, shall be available for disclosure (o the public: Provided, That the use of such data for any registration purpose shall be governed by section 3 of this Act: Provided further, That this paragraph does not authorize the disclosure of any information that— 7 use 13** P.L. 95-396; 92 Sut. 130. Informilton. availability 10 public. 7 USC I36a. FIFRA Compliance/Enforcement 1-31 Guidance Manual 1983 ------- Chapter One FIFBA "(A) discloses maufaciuring or quality conirol pfocesses, "(B) discloses the details of any methods for testing, detecting, or measuring the quantity of any delibraiely added inert ingredient of a pesticide, or "(C) discloses the identity or percentage quantity of any deliberately added inert ingredient of a pesticide, unless the Adminis- trator has first determined that disclosure is necessary to protect against an unreasonable risk of injury to health or the environment. "(2) Information concerning production, distribution, sale, or inven- tories of a pesticide that is otherwise entitled to confidential treatment under subsection (b) of this section may be publicly disclosed in connec- tion with a public proceeding to determine whether a pesticide, or any ingredient of a pesticide, causes unreasonable adverse effects on health or the environment, if the Administrator determines that such disclosure is necessary in the public interest. "(3) If the Administrator proposes to disclose information described in clause (A), (B), or (C) of paragraph (I) or in paragraph (2) of this subsection, the Administrator shall notify by certified mail the submit- ter of such information of the intent to release such information. The Administrator may not release such information, without the submit- ter's consent, until thirty days after the submitter has been furnished such notice: Provided, That where the Administrator finds that disclosure of information described in clause (A), (B), (C) of paragraph (1) of this subsection is necessary to avoid or lessen an imminent and substantial risk of injury to the public health, the Administrator may set such shorter period of notice (but not less than ten days) and such -method of notice as the Administrator finds appropriate. During such • period the data submitter .may institute an action hi .an appropriate district court to enjoin or limit the proposed disclosure. The court shall give expedited consideration to any such action. The court may enjoin disclosure, or limit the disclosure or the parties to whom disclosure shall be made, to the extent that— "(A) in the case of information described in clause (A), (B), or (C) of paragraph (I) of this subsection, the proposed disclosure is not re- quired to protect against an unreasonable risk of injury to health or the environment; or "(B) in the case of information described in paragraph (2) of this subsection, the public interest in availability of the information in the public proceeding does not outweigh the interests in preserving the confidentiality of the information. P.L. 95-3%; "(e) Disclosure to Contractors.—Information otherwise protected from 93 sin. «3i. disclosure to the public subsection (b) of this section may be disclosed to con- tractors with the United States and employees of such contractors if, in the opi- nion o/.the Adminisirat or, such .disclosure is flecessary for thesatisfactory per- formance by the contractor of a contract with the United States for the perfor- mance *of work hi connection with this Act and under such conditions as the Administrator may specify. The Administrator shall require as a condition to the disclosure of information under this subsection that the person receiving it take such security precautions respecting the information as the Administrator shall by regulation prescribe. P.L. 95-3%: "(f) Penalty for disclosure^ by Federal Employees.— 97 Sl" "' """(I) Any officer br~employee of the United States or former officer or employee of the United States who, by virtue of such employment or official position, has obtained possession of, or has access to, material the disclosure of which is prohibited by subsection (b) of this section, .and .who, -knowing lhaidisclosure of such-material is-prohibiied 'fay such subsection, willfully discloses toe material in any manner to any person not entitled to Teceive it, shall be fined not more than SI0,000 or im- prisoned for not more than one year, or both. Section 1905 of title 18 of the United States Code shall not apply with respect to the publishing, divulging, disclosure, or making known of, or making available, infor- mation reported or otherwise obtained under this Act. Nothing in this Act shall preempt any civil remedy under State or Federal law for wrongful disclosure of trade secrets. "(2) For the purposes of this section, any contractor with the United States who is furnished information as authorized by subsection (e) of tiiis section, or any employee ofany such contractor^ shall be considered to toe an tmployeerof the United States. P.L. »$-3%: "(g) Disclosure to Foreign and Multinational Pesticide Producers.— 925)11 •*"• "(1) The Administrator shall not knowingly disclose information submitted by an applicant or registrant under this Act to any employee or agent of any business or other entity engaged in the production, sale, or distribution of pesticides in countries other than the United States or FIFRA Compliance/Enforcement1-32Guidance Manual 1983 ------- Chapter One FIPRA in addition to the United States or to any other person who intends to deliver such data to such foreign or multinational business or entity unless the applicant or registrant has consented to such disclosure. The Administrator shall require an affirmation from any person who intends to inspect data that such person does not seek access to the data for pur- poses of delivering it or offering it for sale to any such business or entity or its agents or employees and will not purposefully deliver or negligent- ly cause the data to be delivered to such business or entity or its agents or employees. Notwithstanding any other provision of this subsection, the Administrator may disclose information to any person in connection with a public proceeding under law or regulation, subject to restrictions on the availability of information contained elsewhere in this Act, which information is relevant to the determination by the Administrator with respect to whether a pesticide, or any ingredient of a pesticide, causes unreasonable adverse effects on health or the environment. "(2) The Administrator shall maintain records of the names of per- sons to whom data are disclosed under this subsection and the persons or organizations they represent and shall inform the applicant or registrant of the names and affiliation of such persons. "(3) Section 1001 of title 18 of the United States Code shall apply to any affirmation made under paragraph (I) of this subsection. "SEC. 11. STANDARDS APPLICABLE TO PESTICIDE APPLICATORS. ' i'« "(a) In General.—No regulations prescribed by (he Administrator for car- rying out (he provisions of this Act shall require any private applicator to maintain any records or file any reports or other documents. "(b) Separate Standards.—When establishing or approving standards for licensing or certification, the Administrator shall establish separate standards for commercial and private applicators. •SEC. 12. UNLAWFUL ACTS. "(a) In General.— "(I) Except as provided by subsection (b), it shall be unlawful for any person in any State lo distribute, sell, offer for sale, hold for sale, ship, deliver for shipment, or receive and (having so received) deliver or offer to deliver, to any person — "(A) any pesticide which is no( registered under section 3, except as provided by section 6(a)( I); "(B) any registered pesticide if any claims made for it as a part of its distribution or sale substantially differ from any claims made for it as a part of the statement required in connection with its registra- tion under section 3; "(C) any registered pesticide the composition of which differs at the time of its distribution or sale from its composition as described in the statement required in connection with its registration under section 3; "(D) any pesticide which has not been colored or discolored pur- suant to the provisions of section 25(c)(5); "(E) any pesticide which is adulterated or misbranded; or "(F) any device which is misbranded. "(2) It shall be unlawful for any person — "(A) to detach, alter, deface, or destroy, in whole or in part, any labeling required under this Act; "(B) to refuse to keep any records required pursuant to section 8, or to refuse to allow the inspection of any records or establishment pursuant lo section 8 or 9, or to refuse to allow an officer or employee of the Environmental Protection Agency to take a sample ' of any pesticide pursuant to section 9; "(Q to give a guaranty or undertaking provided for in subsection (b) which is false in any particular, except that a person who receives and relies upon a guaranty authorized under subsection (b) may give a guaranty to the same effect, which guaranty shall contain, in addi- tion to his own name and address, the name and address of the per- son residing in the United States from whom he received the guaran- ty or undertaking; "(D) to use for his own advantage or to reveal, other than to the Administrator, or officials or employees of the Environmental Pro- tection Agency or other Federal executive agencies, or to the courts, '*•< 7 us< ' use u<>. 7 use \M. FIFRA Compliance/Enforcement 1-33 Guidance Manual 1983 ------- Chapter One FIFRA ^ USf 7 USC IJAa. P.I. 95096; 92 Slat. 132. 7 USC IJ6k: 7 USC I3W. 7 USC I36c. "7 USC" I.We. IW. or to physicians, pharmacists, and other qualified persons, needing such information for the performance of their duties, in accordance with such directions as the Administrator may prescribe, any infor- mation acquired by authority of this Act which is confidential under this Act; "(E) who is a registrant, wholesaler, dealer, retailer, or other distributor to advertise a produce registered under (his Act for restricted use without giving (he classification of the product as- signed to it under section 3; "(F) to make available for use, or to use, any registered pesticide classified for restricted use for some or all purposes other than in ac- cordance with section 3(d) and any regulations thereunder; Provided, That it shall not be unlawful to sell, under regulations issued by the Administrator, a restricted use pesticide to a person who is not a certified applicator for application by a certified ap- plicator; "(C) to use any registered pesticide in a manner inconsistent with its labeling; "(H) to use any pesticide which is under an experimental use per- mit contrary to the provisions of such permit; "(I) to violate any order issued under section 13; "(J) to violate any suspension order issued under section 6; "(K) to violate any cancellation of registration of a pesticide under section 6, except as,provided by section 6(a)(l); "(L) who is a producer to violate any of the provisions of section 7; . "(M) to knowingly falsify all or part of any application for registration, application for experimental use permit, any informa- tion submitted to (he Administrator pursuant to section 7, any records required to be maintained pursuant to section 8, any report filed under this Act, or any information marked as confidential and submitted (o the Administrator under any provision of this act; "(N) who is a registrant, wholesaler, dealer, retailer, or other distributor to fail to file reports required by this Act; "(O) to add any substance to, or take any substance from, any pesticide in a manner that may defeat the purpose of this Act; or "(P) to use any pesticide in tests on human beings unless such human beings (i) are fully informed of the nature and purposes of the test and of any physical and mental health consequences which are reasonably foreseeable therefrom, and (ii) freely volunteer to par- ticipate in the test. "(b) Exemptions.—The penalties provided for a violation of paragraph (1) of subsection ------- Chapter One FIFRA visions of this Act, or that such pesticide or device has been or is intended to be distributed or sold in violation of any such provisions, or when the registra- tion of the pesticide has been canceled by a final order or has been suspended, the Administrator may issue a written or printed 'stop sale, use, or removal' order to any person who owns, controls, or has custody of such pesticide or device, and after receipt of such order no person shall sell, use, or remove the pesticide or device described in the order except in accordance with the provi- sions of the order. "(b) Seizure.—Any pesticide or device that is being transported or, having been transported, remains unsold or in original unbroken packages, or that is sold or offered for sale in any State, or that is imported from a foreign coun- try, shall be liable to be proceeded against in any district court in the district where it is found and seized for confiscation by a process in rem for condem- nation if— "(I) in the case of a pesticide— "(A) it is adulterated or misbranded; "(B) it is not registered pursuant to the provisions of section 3; "(C) its labeling fails to bear the information required by this Act; "(D) it is not colored or discolored and such coloring or discolor- ing is required under this Act; or "(E) any of the claims made for it or any of the directions for its use differ in substance from the representations made in connection 'with its registration; "(2) in the case of a device, it is misbranded; or "(3) in the case of a pesticide or device, when used in accordance with the requirements imposed under this Act and as directed by the labeling, it nevertheless causes unreasonable adverse effects on the en- vironment. In the case of a plant regulator, defoliant, or desiccant, used in accordance with the label claims and recommendations, physical or physiological effects on plants or parts thereof shall not be deemed to be injury when such effects are the purpose for which the plant regulator, defoliant, or desiccant was applied. "(c) Disposition After Condemnation.—If the pesticide or device is con- demned it shall, after entry of the decree, be disposed of by destruction or sale as the court may direct and the proceeds, if sold, less the court costs, shall be paid into the Treasury of the United States, but the pesticide or device shall not be sold contrary to the provisions of tnis Act or the laws of the jurisdiction in which it is sold; Provided, That upon payment of the costs of the condem- nation proceedings and the execution and delivery of a good and sufficient bond conditioned that the pesticide or device shall not be sold or otherwise disposed of contrary to the provisions of the Act or the laws of any jurisdic- tion in which sold, the court may direct that such pesticide or device be delivered to the owner thereof. The proceedings of such condemnation cases shall conform, as near as may be to the proceedings in admiralty, except that either party may demand trial by jury of any issue of fact joined in any case, and ail such proceedings shall be at the suit of and in the name of the United States. "(d) Court Costs, Etc.—When a decree of condemnation is entered against the pesticide or device, court costs and fees, storage, and other proper ex- penses shall be awarded against the person, if any, intervening as claimant of the pesticide or device. 'SEC. 14. PENALTIES. "(a) Civil Penalties.— "(1) In General.—Any registrant, commercial applicator, whole- saler, dealer, retailer, or other distributor who violates any provision of this Act may be assessed a civil penalty by the Administrator of not more than $5,000 for each offense. "(2) Private Applicator.—Any private applicator or other person not included in paragraph (I) who violates any provision of this Act subse- quent to receiving a written warning from the Administrator or follow- ing a citation for a prior violation, may be assessed a civil penalty by the Administrator of not more than SI,000 for each offense: Provided, That any applicator not included under paragraph (1) of this subsection who holds or applies registered pesticides, or use dilutions of registered pesticides, only to provide a service of controlling pests without deliver- ing any unapplied pesticide to any person so served, and who violates ' any provision of this Act may be assessed a civil penalty by the Ad- ministrator of not more than$500 for the first offense nor more than 51,000 for each subsequent offense. 1 USC I3M P.I.. V5-J96: n Slal. >32. FIFRA Compliance/Enforcement 1-35 Guidance Manual 1983 ------- Chapter One FUBA "(3) Hearing. — No civil penalty shall be assessed unless ihe person charged shall have been given notice and opportunity for a hearing on such charge in the county, parish, or incorporated city of the residence of the person charged. P.I . "»5-.m: "(4) Determination of Penalty.—In determining the amount of 92S'ai *V1 the penalty, the Administrator shall consider the appropriateness of such penalty to the size of the business of the person charged, the effect on the person's ability to continue in business, and the gravity of the viola- tion. Whenever the Administrator finds that the violation occurred despite the exercise of due care or did not cause significant harm to health or the environment, the Administrator may issue a warning in lieu of assessing a penalty.". "(5) References to Attorney General.—In case of inability to collect such civil penalty or failure of any person to pay all, or such portion of such civil penalty as the Administrator may .determine, the Ad- . ministrator shall refer the. matter to the Attorney General, who shall recover such amount by action in the appropriate United States district court. "(b) Criminal Penalties.— "(I) In General.— Any registrant, commercial applicator, wholesaler, dealer, retailer, or other distributor who knowingly violates any provision of this Act shall be guilty of a misdemeanor and shall on conviction be fined not more than $25,000, or imprisoned for not more than one year, or both. "(2) Private applicator.— Any private applicator or other person not included in paragraph (1) who knowingly violates any provision of this Act shall be guilty of a misdemeanor and shall on conviction be fined not .more.than il.OOO, or imprisoned for not more than 30 days, or both. "(3) Disclosure of information.—Any person, who, with intent to defraud, uses or reveals information relative to formulas of products ac- T use i3oi quired under the authority of section 3, shall be fined not more than$10,000, or imprisoned for not more than three years, or both. "(4) Acts of officers, agents, etc.—When construing and enforcing the provisions of this Act, the act, omission, or failure of any officer, agent, or other person acting for or employed by any person shall in every case be also deemed to be the act, omission, or failure of such per- son as well as that of the person employed. 7 use »6» "SEC. 15. INDEMNITIES. **(a) -Requirement.—If— "(1) the Administrator notifies a registrant that: he has suspended the registration of a pesticide because such action is necessary to prevent an imminent hazard; "(2) the registration of the pesticide is canceled as a result of a final determination that the use of such pesticide will create an imminent hazard; and "(3) any person who owned any quantity of such pesticide im- mediately before the notice to the registrant under paragraph (I) suf- fered losses by reason of suspension or cancellation of the registration. The Administrator shall make an indemnity payment to such person, unless the Administrator finds that such person (i) had knowledge of facts which, in themselves, would have shown .that such -pesticide did 7 use 136. . not meet 'the requirements of section 3(c)(5) .for registration, and (ii) continued thereafter to produce such pesticide without giving timely notice of such facts to the Administrator. "(b) Amount of Payment.— "(I) In General.—The amount of the indemnity payment under subsection (a) to any person shall be determined on the basis of the cost of the pesticide owned by such person immediately before the notice to the registrant referred to in subsection (a)(l); except that in no event shall an indemnity payment to any person exceed the fair market value of the pesticide owned by such person immediately before Ihe notice referred to in subsection (aM 1). "(2) Special ro/e—Notwithstanding any other provision of his Act, the Administrator may provide a reasonable time for use or other disposal of such pesticide. In determining the quantity of any pesticide for which indemnity shall be paid under this subsection, proper adjust- ment shall be made for any pesticide used or otherwise disposed of by such owner. FIFRA Compliance/Eoforceaent 1-36 '. Guidance Manual 1Q«1 ------- Chapter One FIFRA "SEC. 16. ADMINISTRATIVE PROCEDURE; JUDICIAL REVIEW. 7 use ut. "(a) District Court Review.— Except as is otherwise provided in this Act, Agency refusals to cancel or suspend registrations or change classifications not following a hearing and other final Agency actions not committed to Agency discretion by law are judicially reviewable in the district courts. "(b) Review by Court of Appeals.—In the case of actual controversy as to the validity of any order issued by the Administrator following a public hear- ing, any person who will be adversely affected by such order and who had been a party to the proceedings may obtain judicial review by filing in the United States court of appeals for the circuit wherein such person resides or has a place of business, within 60 days after the entry of such order, a petition pray- ing that the order be set aside in whole or in part. A copy of the petition shall be forthwith transmitted by the clerk of the court to the Administrator or any officer designated by him for that purpose, and thereupon the Administrator shall file in the court the record of the proceedings on which he based his order, as provided in section 2112 of title 28, United States Code. Upon the fit- ?:siai. MM ing of such petition the court shall have exclusive jurisdiction to affirm or set nosiai. 1323 aside the order complained of in whole or in part. The court shall consider all evidence of record. The order pt the Administrator shall be sustained if it is supported by substantial evidence when considered on the record as a whole. The judgment of the court affirming or setting aside, in whole or in part, any order under this section shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as pro- vided in section 1254 of title 28 of the United States Code. The commencement *: sui ------- Chapter One FIFRA right to introduce testimony. If it appears from the examination of a sample that it is adulterated, or misbranded or otherwise violates the provisions set forth in this Act, or is otherwise injurious to health or the environment, the pesticide or device may be refused admission, and the Secretary of the Treasury shall refuse delivery to the consignee and shall cause the destruction of any pesticide or device refused delivery which shall not be exported by the consignee within 90 days from the date of notice of such refusal under such regulations as the Secretary of Treasury may prescribe: Provided, That the Secretary of the Treasury may deliver to the consignee such pesticide or device pending examination and decision in the matter on execution of bond for the amount of the full invoice value of such pesticide or device, together with the duty thereon, and on refusal to return such pesticide or device for any cause to the custody of the Secretary of the Treasury, when demanded, for the purpose of excluding them.from the country, or for any other purpose, said consignee shall forfeit the full amount of said bond: And provided further, That all charges for storage, cartage, and tabor on pesticides or devices which are refused admission or delivery shall be paid by the owner or consignee, and in default of such payment shall constitute a lien against any future importation made by such owner or consignee. "(d) Cooperation in International Efforts.—The Administrator shall in cooperation with the Department of State and any other appropriate Federal agency, participate and cooperate in any international efforts to develop im- proved pesticide research and regulations. "(e) Regulations.—The Secretary of the Treasury, in consultation with the Administrator, shall prescribe regulations for the enforcement of subsection (c) of this section. 1USC 13** I'.l . 44-1411: K") Siai. 7\4. "SEC. 18. EXEMPTION OF FEDERAL AGENCIES. "The Administrator may, at his discretion, exempt any Federal or State "agency from any provision of (his Act if he deiermines that emergency condi- tions exist which require such exemption. "The Administrator, in determining whether or not such emergency condi- tions exist, shall consult with the Secretary of Agriculture and the Governor of any Stale concerned if they request such determination." 7 USf Ij6q 7 use u*d KJSial. »44; 74 Sin. 80S; 79Siai. 286: 72Sill. 775: 15 Sill 4«!. Conlravi Authority. "SEC. 19. DISPOSAL AND TRANSPORTATION. "(a) Procedures.—The Administrator shall, after consultation with other ..interested Federal agencies, establish procedures and -regulations for the disposal OT storage of packages and containers of pesticides and for disposal or storage of excess amounts of such pesticides, and accept at convenient loca- tions for safe disposal a pesticide the registration of which is canceled under section 6(c) if requested by the owner of the pesticide. "(b) Advice to Secretary of Transportation.—The Administrator shall pro- vide advice and assistancr to the Secretary of Transportation with respect to his functions relating to the transportation of hazardous materials under the Department of Transportation Act (49 U.S.C. 1657), the Transportation of Explosives Act (18 U.S.C. 831-835), the Federal Aviation Act of 1958 (49 U.S.C. 1421-1430, 1472 11), and the Hazardous Cargo Act (46 U.S.C. 170. 375. 416). *'(c) ^Vo*roonj/or»vm«s«/OTwnm«.—^Notification of cancellation of any .•pesticide shaDinciudespedficprovisions for the disposal of the unused quan- tities of such pesticide. 7 use iJ*» •M.. »»•»: KSui «34. "SEC. 20. RESEARCH AND MONITORING. "(a) Research.—The Administrator shall undertake research, including research by grant or contract with other Federal agencies, universities, or others AS may Jje necessaryto cawy-out Ihe purposes of 4his Act.-and toe shall conduct research into .integrated pest iramagrmnil -in -coordination with the Secretary of Agricu1ture:The Administrator shall also take care to insure that such research does not duplicate research being undertaken by any other Federal agency. "(b) National Monitoring Plan.—The Administrator shall formulate and periodically revise, in cooperation with other Federal, State, or local agencies, a national plan for monitoring pesticides. FIFSA Compliance/EnforcemenF 1-38 Guidance Manual 1983 ------- Chapter One FIFRA "(c) Monitoring.—The Administrator shall undertake such monitoring ac- tivities, including, but not limited to, monitoring in air, soil, water, man, plants, and animals, as may be necessary for the implementation of this Act and of the national pesticide monitoring plan. The Administrator shall establish procedures for the monitoring of man and animals and their environ- ment for incidental pesticide exposure, including, but not limited to, the quan- tification of incidental human and environmental pesticide pollution and the secular trends thereof, and identification of the sources of contamination and their relationship to human and environmental effects. Such activities shall be carried out in cooperation with other Federal, State, and local agencies. P.L. 95-396; 92 Slai. 8.14. "SEC. 21. SOLICITATION OF COMMENTS; NOTICE OF PUBLIC HEARINGS. "(a) The Administrator, before publishing regulations under this Act, shall solicit the views of the Secretary of Agriculture in accordance with the pro- cedure described in section 25(a). "(b) In addition to any other authority relating to public hearings and solicitation of views, in connection with the suspension or cancellation of a pesticide registration or any other actions authorized under this Act, the Ad- ministrator may, at his discretion, solicit the views of all interested persons, either orally or in writing, and seek such advice from scientists, farmers, farm organizations, and other qualified persons as he deems proper. "(c) In connection with all public hearings under this Act the Ad- ministrator shall publish timely notice of such hearings in the Federal Register. P.L. 94-140; 89Slai. 7?2; 7 USl I Publication' in Federal Rcxi«cr. "SEC. 22. DELEGATION AND COOPERATION. "(a) Delegation.—All authority vested in the Administrator by virtue of the provisions of this Act may with like force and effect be executed by such employees of the Environmental Protection Agency as the Administrator may designate for the purpose. "(b) Cooperation.—The Administrator shall cooperate with the Depart- ment of Agriculture, any other Federal agency, and any appropriate agency of any State or any political subdivision thereof, in carrying out the provisions of this Act, and in securing uniformity of regulations. 7 USf "SEC. 23. STATE COOPERATION, AID, AND TRAINING. "(a) Cooperative Agreements.—The Administrator may enter into cooperative agreements with States and Indian tribes— "(I) to delegate to any State or Indian tribe the authority to cooperate in the enforcement of this Act through the use of its personnel or facilities, to train personnel of the State or Indian tribe to cooperate in the enforcement of this Act, and to assist States and Indian tribes in implementing cooperative enforcement programs through grants-in-aid; and "(2) to assist States in developing and administering State programs. and Indian tribes that enter into cooperative agreements, to train and certify applicators consistent with the standards the Administrator prescribes. Effective with the fiscal year beginning October 1, 1978, there are author- ized to be appropriated annually such funds as may be necessary for the Ad- ministrator to provide through cooperative agreements an amount equal to SO percent of the anticipated cost to each State or Indian tribe, as agreed to under such cooperative agreements, of conducting training and certification pro- grams during such fiscal year. If funds sufficient to pay SO percent of the costs Tor any year are not appropriated, the share of each State and Indian tribe shall be reduced in a like proportion in allocating available funds. "(b) Contracts for Training.—In addition, the Administrator may enter in- to contracts with Federal, State, or Indian tribal agencies for the purpose of encouraging the training of certified applicators. "(c) Information and Education.—The Administrator shall, in coopera- tion with the Secretary of Agriculture, use the services of the cooperative State extension services to inform and educate pesticide users about accepted uses and other regulations made under this Act. 7 use lit* P.L. »<-J94; 92 Slai. 8X FIFRA Compliance/Enforcement 1-39 Guidance Manual 1983 ------- Chapter One FIFRA 7 use .36- "SEC. 24. AUTHORITY OF STATES. PI. »s-3»»: "(a) A State may regulate the sale or use of any federally registered 92 sm. 83<. pesticide or device in the Slate, but only if and to the extent the regulation does not permit any sale or use prohibited by this_Act. "(b) Such Stale shall not impose or continue in effect any requirements for labeling or packaging in addition 10 or different from those required under (his Act. "(c)(l) A Stale may provide registration for additional uses of federally registered pesticides formulated for distribution and use within that State lo meet special local needs in accord with the purposes of this Act and if registration for such use has not previously been denied, disap- proved, or cancelled by the Administrator. Such registration shall be 7 use 13*.. deemed registration under section 3 for all purposes of this Act, but shall authorize distribution and use only within such State. "(2) A registration issued by a State under this subsection shall not be.effective for more than ninety days if disapproved by the Ad- ministrator within that period. Prior to disapproval, the Administrator shall, except 35 provided in paragraph (3) of this subsection, advise the State of the Administrator's intention to disapprove and the reasons therefor, and provide the State time to respond. The Administrator shall not prohibit or disapprove a registration issued by a State under this subsection (A) on the basis of lack of essentiality of a pest icide or (B) ex- cept as provided in paragraph (3) of this subsection, if its composition and use patterns are similar to those of a federally registered pesticide. "(3) In no instance may a State issue a registration for a food or feed 21 use MI. use unless there exists a tolerance or exemption under the Federal Food, Drug, and Cosmetic Aci that permits the residues of the pesticide on the food or feed. If the Administrator determines that a registration issued by a State is inconsistent with the Federal Food, Drug, and Cosmetic Act, or the use of a pesticide under a registration issued by a State con- stitutes an imminent hazard, the Administrator may immediately disap- prove the registration. "(4) If the Administrator finds, in accordance with standards set 7 use 136-. forth in regulations issued under section 25 of this Act, that a State is not capable of exercising adequate controls to assure that State registra- tion under this station will be in accord with the purposes of this act or has failed to exercise adequate controls, the Administrator may suspend the authority of the State to register pesticides until such Urge as the Ad- ministrator is satisfied that the State can and will exercise adequate con- trols. Prior to any such suspension, the Administrator shall advise the State of the Administrator's intention to suspend and the reasons therefor and provide the State time to respond.". 7 use i»- -SEC. 25. AUTHORITY OF ADMINISTRATOR. r. L. *M40: "(a)(l) Regulations. — The Administrator is authorized in accordance with *9'1"' 5I the procedure described in paragraph (2), to prescribe regulations to carry out the provisions of this Act. Such regulations shall take into ac- count the difference in concept and usage between various classes of pesticides and differences in environmental risk and the appropriate data for evaluating such risk between agricultural and nonagricultural pesticides. •"(A) PraposedmguiaiiamSi~At:ieasti60 days prior to signing any .proposed regulation for publication in the Federal Register, the Ad- ilRlnVin ministrator shall provide the Secretary of Agriculture with a copy of cjwn. suc^ regulation. If the Secretary comments in writing to the Ad- ministrator regarding any such regulation within 30 days after receiv- ing it, the Administrator shall publish in the Federal Register (with ,- the proposed regulation) the comments of the Secretary and the 1! «j*' response of the Administrator with regard to the Secretary's com- ments.._lf_thc Secretary does not comment in writing to the Ad- ministrator regarding the regulation within 30 days after receiving it, the Administrator may sign such regulation for publication in the federal Register anytime after such JCMlay period notwithstanding -the •foregoingr^O^day >iinie requirement . "(B) Final regulations. — At least 30 days prior (o signing any regulation in final form for publication in the Federal Register, the Pubiiiiiion in Administrator shall provide the Secretary of Agriculture with a copy F«i«ai Rrtiue> qfjuch regulation. If the Secretary comments in writing to the Ad- ministrator regarding any such final regulation within 15 days after receiving it, the Administrator shall publish in the Federal Register FIFRA Compliance/Enforcement 1-40 Guidance Manual 1983 ------- Chapter One FIFRA (with the final regulation) the comments of the Secretary, if re- quested by the Secretary, and the response of the Administrator con- cerning the Secretary's comments. If the Secretary does not comment in writing to the Administrator regarding the regulation within 15 days after receiving it, the Administrator may sign such regulation for publication in the Federal Register at any time after such 15-day period notwithstanding the foregoing 30-day time requirement. In taking any final action under this subsection, the Administrator shall include among those factors to be taken into account the effect of the regulation on production and prices of agricultural com- modities, retail food prices, and otherwise on the agricultural economy, and the Administrator shall publish in the Federal Register an analysis of such effect. "(C) Time requirements. — The time requirements imposed by subparagraphs (A) and (B) may be waived or modified to the extent agreed upon by the Administrator and the Secretary. "(D) Publication in the federal register.— The Administrator shall, simultaneously with any notification to the Secretary of Agriculture under this paragraph prior to the issuance of any pro- posed or final regulation, publish such notification in the Federal Register.". "(3) Congressional Committees.— At such time as the Administrator is required under paragraph (2) of this subsection to provide the Secretary of Agriculture with a copy of proposed regulations and a copy of the final form of regulations, he shall also furnish a copy of such regulations to the Committee on Agriculture of the House of Represen- tatives and the Committee on Agriculture and Forestry of the Senate." "(4) RULE AND REGULATION REVIEW. — "(A) CONGRESSIONAL REVIEW. — Notwithstanding any other provision of this Act, simultaneously with promulgation of any rule or regulation under this Act, • the- Administrator shall transmit a copy thereof to the Secretary of the Senate and the Clerk of the House of Representatives. Except as provided in subparagraph (B), the rule or regulation shall not become effective, if within 90 calendar days of continuous session of Congress after the dare of promulgation, both Houses of Congress adopt a concurrent resolution, the matter after the resolving clause of which is at follows: "That Congress disapproves the rule or regulation pro- mulgated by the Administrator of the Environmental Protection Agency dealing with the flatter of , which rule or regulation was transmitted to Congress on , the blank spaces therein being appropriately filled. [Added by PL 96-539, Dec. 18, 1980] "(B) EffECTrvE DATE. — If at the end of 60 calendar days of continuous ses- sion of Congres* after the date of promulgation of a rule or regulation, no com- mittee of either House of Congress has reported or been discharged from further consideration of a concurrent resolution disapproving the rule or regulation, and neither House has adopted such a resolution, the rule or regulation may go into ef- fect immediately. If, within such 60 calendar days, such a. committee- has reported or bear discharged from further consideration of such a resolution, or either House has adopted such a resolution, the rule or regulation may go into effect not sooner than 90 calendar days of continuous session of Congress after its pro- mulgation unless disapproved as provided in subparagraph (A). [Added by PL 96-539, Dec. 17, 1980) "(Q For the purposes of subparagraphs (A) and (B) of this paragraph— [Added by PL 96-539, Dec. 17, 1980] "(i) continuity of session is broken only by an adjournment of Congress sine die;, and [Added by PL 96-539, Dec.-17, 1980] "00_- the days on, which either House is not in- session because of an ad- . jounnnent of more than 3 days R> a day certain are excluderf in the computa- tion ofc 60 and 90 calendar days, of continuous session of Congress. [Added by PL 96-539, Dec. 17, 1980) "(D) EFFECT OF CONGRESSIONAL INACTION. — Congressional inaction on or re- jection of * resolution of disapproval shall not be deemed an expression of ap- proval of such rule. [Added by PL 96-539, Dec. 17, T980] "(E) JUDICIAL REVIEW.— "(D Any interested party, including any person who participated in the . rulemaking. involved, may institute such actions in the appropriate district court of the United States, including actions for declaratory judgment, as ., may be appropriate to construe the constitutionality of any provision of this •• paragraph. The district court immediately shall certify all questions of the constitutionality of this paragraph to the United States court of appeals for the. circuit involved, which shall hear the. matter sitting en bane. [Added by PL 96-539, Dec. 17, 1980] P.L. 95-396; 92 Slal. 836. Publication in Federal Refisier. P.L. 9*-l40; 89Siai. 733. FIFRA Compliance/Enforcement 1-41 Guidance Manual 1983 ------- Chapter One FIFRA MSiai. 1670. 15 USC' 1471 nolc. P.L. M-144 »» Stot. 75* T USC IMd. r usc u«w. 1»BkUn*to» la PabUemdoKln m "(h> Notwithstanding any other provision of law, any decision on a matter certified under clause (i) of this subparagraph shall be reviewable by appeal directly to the Supreme Court of the United Stales. Such appeal shall be brought not later than 20 days- after the decision of the court of appeals. (Added.by PL 96-539. Dec. IT, 1980] " "(iii) It shall be theduty of the court of appeals and of the Supreme Coun of the United States to advance on the docket and to expedite to the greatest possible extent the disposition of any matter certified under clause (i) of this subpangraph. (Added, by PL 96-539, Dec. 17. 1980] "(b) Exemption of Pesticides.—The Administrator may exempt from the requirements of this Act by regulation any pesticide which he determines either (I) to be adequately regulated by another Federal agency, or (2) to be of a character which is unnecessary to be subject to this Act in order to carry out the purposes of this Act. "(c) Other Authority.— The Administrator, after notice and opportunity for hearing, is authorized— '•(I) to declare a pest any form of plant or animal life (other than man and other than bacteria, virus, and other micro-organisms on or in living man or other living animals) which is injurious to health or the en- vironment: "(2) to determine any pesticide which contains any substance or substances in quantities highly toxic to man; "(3) to establish standards (which shall be consistent with those established under the authority of the Poison Prevention Packaging Act (Public Law 91-601)) with respect to the package, container, or wrap- ping in which a pesticide or device is enclosed for use or consumption, in order to protect children and adults from serious injury or illness resulting from accidental ingestion or contact with pesticides or devices regulated by this Act as well as to accomplish the other purposes of this Act; "(4) to specify those classes of devices which shall be subject to any •provision of paragraph 2(q)(l) or section 7 of this Act upon his_deter- mination that application of such provision is necessary lo effectuate the purposes of this Act; "(5) lo prescribe regulations requiring any pesticide lo be colored or discolored if he determines that such requirement is feasible and is necessary for the protection of health and the environment; and "(6) to determine and establish suitable names lo be used in the in- gredient statement. "(d) SCIENTIKU: ADVISORY PANEL.—The Administrator shall submit to an advisory panel for comment 3N to the impact on health and the environment of the action proposed til notices of intent issued under section 6(b) and of the proposed and finul form of regulations issued under section- 25(a) within the same time periods as provided for the comments of the Secretary of Agriculture under such sections. The time- requirements for notices of intent and proposed and fin:il forms of regulation may not be modified or waived unless in jddition lo mccimg the requirements of section 6(6) or ,25(a>. as-applicable, the advisory panel has .failed to comment on the ;proppNcd- action within the prescribed time period or has agreed to the modification, or waiver. The Administrator shall also solicit from the advisory panel comments, evaluations, and recommendations for operating guidelines to improve the effectiveness and quality of scientific analyses made by personnel of the Environmental Protection Agency that lead to decisions by the Administrator in carrying our the provisions of this Act. The comments, evaluations, and. recom- mendations of the advisory panel and the response of the Administrator shall be published in the Federal Register in the same mariner as provided for publication of of the comments of the Secretary of Agriculture under such sections. The chairman of the advisory panel, after consultation- with the Administrator, may create tem- porary subpanels on-specific projects to assist-the full-advisory .panel in expediting mayoe;compo«gd of »aiiBiy other than- members of the advisory 'panel, as deemed necessary for the purpose of evaluating scientific studies relied upon by the Administrator with respect to proposed action_Such additional scientists shall be selected by the advisory panel. The panel referred to in this subsection shall consist of seven- members appointed by the Administrator from a list of 12- nommees, six nominated by the National Institutes of Health, and six by the Na- tional-Science Foundation-. The Administrator may require such information from the nominees- to the advisory panel as he deems necessary, and he shall publish in the Federal Register the name, address, and professional affiliations of each nominee. Each member of the panel shall receive per diem compeatauonai-a-raie n«,in excess of that fixed for GS-18 of the GeneralScntdUJe as may be determined toy-the AdmmisTTator^cttgpr that .any ••such- member *«mo holds another office or position under the Federal Government the compensation for which exceeds such rate may elect to receive compensation at the rate provided for such other office or position in lieu of the compensation provided by this subsection. In order to assure the objectivity of the advisory panel, the Administrator shall promulgate regula- tions regarding conflicts of interest with respect to the members of the panel. The TXFRA Compliance/Enforcement 1-42 Guidance Manual 1983 ------- Chapter One FLFEA advisory panel established under this subsection shall terminate September 30, 1981. In performing the functions assigned by this Act; the panel shall consult and coordinate its activities with the Science Advisory Board established under the En- vironmental Research, Development, and Demonstration- Authorization Act of 1978. Whenever the Administrator exercises authority under section 6(c) of this- Act to immediately suspend the- registration' of any pesticide to prevent an im- minent hazard, the Administrator shall promptly submit to the advisory panel for comment, as to the impact on health and trie-environment, the action taken to sus- pend the-registration- of such pesticide. [Amended by PL 96-539; Dec. 17, 1980f "(e) PEER REVIEW. —The Administrator shall, by written procedures, provide for peer review with" respect to the-design, protocols, and conduct of major, scien- tific studies conducted under this Acr by the Environmental Protection Agency or by any other Federal agency, *ny State or political subdivision thereof, or any in- stitution or individual under grant, contract, or cooperative agreement from or with the Environmental Protection Agency. In such procedures, the Ad- ministrator shall also provide for peer review, using the advisory panel established under subsection (d) of this section or appropriate experts appointed by the Ad- ministrator from a current list of nominees maintained by such panel, with respect to the results of any such scientific uudies relied upon by the Administrator with respect to actions the Administrator may take relating to the change in classifica- tion, suspension, or cancellation of a pesticide: Provided, That whenever the Ad- ministrator determines that circumstances do not permit the peer review of the results of any such scientific study prior to the Administrator's exercising authority under section 6(c) of this Act to immediately suspend the registration of any pesticide to prevent an imminent hazard, the Administrator shall promptly thereafter provide for the conduct of peer review as provided in this sentence. The evaluations and relevant documentation constituting the peer review that relate to the proposed scientific studies and the results of the completed scientific studies shall be included in the submission for comment forwarded by the Administrator to the advisory panel as provided in subsection (d). As used in this subsection, the term 'peer review' shall mean an independent evaluation by scientific experts, either within or outside the Environmental Protection Agency, in the appropriate disciplines." [Added by PL 96-539, Dec. 17, 1980] {Editor's note: Section 2(b) of PL 96-539 provides: "(b) The provisions of this jection shall become effective upon publication in the Federal Register of final procedures for peer review as-provided in this section, but in no event shall such provision* become effective later than one year after the date of enactment of thi» ACL") Advtaory p*ncl. (ernuuiton. 42 USC 4365. 1 USC 136d. 7 USC 13M. Comments. "P«r revkw." r*Mk»0Mii Fedenl 7 USC 13*- WM«. "SEC. 26. STATE PRIMARY ENFORCEMENT RESPONSIBILITY. "(a) For the purposes of this Act, a State shall have primary enforcement responsibility for pesticide use violations during any period for which the Ad- ministrator determines that such State— "(1) has adopted adequate pesticide use laws and regulations; Pro- vided, That the Administrator may not require a Stale to have pesticide use laws that are more stringent than this Act; . "(2) has adopted and is implementing adequate procedures for the enforcement of such State laws and regulations: and "(3) will keep such records and make such reports showing com- pliance with paragraphs (1) and (2) of this subsection as the Ad- ministrator may require by regulation. "(b) Notwithstanding the provisions of subsection (a) of this section, any State that enters into a cooperative agreement with the Administrator under section 23 of this Act for the enforcement of pesticide use restrictions shall have the primary enforcement responsibility for pesticide use violations. Any State that has a plan approved by the Administrator in accordance with the re- quirements of section 4 of this Act that the Administrator determines meets the criteria set out in subsection (a) of this section shall have the primary en- forcement responsibility for pesticide use violations. The Administrator shall make such determinations with respect to Slate plans under Section 4 of (his Act in effect on September 30, 1978 not later than March31. 1979. "(c) the Administrator shall have primary enforcement responsibility for those States that do not have primary enforcement responsibility under this Act. Notwithstanding the provisions of section 2(e) (I) of this Act, during any period when the Administrator has such enforcement responsibility, section 8(b)of this Act shall apply to the books and records of commercial applicators and to any applicator who holds or applies pesticides, or use dilutions of pesticides, only to provide a service of controlling pests without delivering any unapplied pesticide to any person so served, and section 9(a) of this Act shall apply to the establishment or other place where pesticides or devices are held for application by such persons with respect to pesticides or devices held for such application. 7 USC I34--I P.L. 95-396; 92Sui 836. 7 USC IM.u 7 USC' IJAb 7 USC 136 7 USC I3«f 7 USC IJ6f FIFBA Compliance/Enforcement 1-43 Guidance Manual 1983 ------- Chapter One FIFRA 7 USC IJ6--J P.L. 95-3%: 9: Slai. 637. 7 USC 136».| 7 USC IJ6..J P.I.. 9JO%: 92 Siai.-XM. 7 use ij6»-< P.I. V«-J%- 92 Slat. 838 7 USC IJ6a 7 use I PL 94-109 89 Stot 5-Tt- t» Sta*. TU 7 USC 1M*. PL 96-539- 94 Stat. 3194. "SEC. 27. FAILURE BY THE STATE TO ASSURE ENFORCEMENT OF STATE PESTICIDE USE REGULATIONS. "(a) Upon receipt of any complaint or other information alleging or in- dicating a significant violation of the pesticide use provisions of this Act, the Administrator shall refer the matter to the appropriate State officials for their investigation of the matter consistent with the requirements of this Act. If, within thirty days, the State has not commenced appropriate enforcement ac- tion, the Administrator may act upon the complaint or information to the ex- lent authorized under this Act. "(b) Whenever the Administrator determines that a State having primary enforcement responsibility for pesticide use violations is not carrying out (or cannot carry out due to the lack of adequate legal authority) such responsibili- ty, the Administrator shall notify the State. Such notice shall specify those aspects of the administration of the State program that are determined to be inadequate. The State shall have ninety days after receipt of the notice to cor- rect any deficiencies. If after that time the Administrator determines that the State program remains inadequate, the Administrator may rescind, in whole or in pan, the State's primary enforcement responsibility for pesticide use violations. "(c) Neither section 26 of this Act nor this section shall limit the authority of the Administrator to enforce this Act, where the Administrator determines that emergency conditions exist that require immediate action on the part of the Administrator and the State authority is unwilling or unable adequately to respond to the emergency. "SEC. 28. IDENTIFICATION OF PESTS; COOPERATION WITH DEPARTMENT OF AGRICULTURE'S PROGRAM. "The Administrator, in coordination with the Secretary of Agriculture, .shall .identify those pests that must be brought under control. The Ad- ministrator shall also coordinate and cooperate with the Secretary of Agriculture's research and implementation programs to develop and improve the safe use and effect ix-cucvs of chemical, biological, and alternative methods to combat and control pests that reduce the quality and economical produc- tion and distribution of agricultural products to domestic and foreign con- sumers. "SEC. 29. ANNUAL RKPORT. "The Administrator shall submit an annual report to Congress before February 16 of each year and the first report shall be due February 15, 1979. The report shall include the total number of applications for conditional registration under section 3(c)(7)(B) and 3(c)(7)(C) of this Act that were filed during the immediately preceding fiscal year, and, with respect to those ap- plications approved, the Administrator shall report the Administrator's find- ings in each case, the conditions imposed and any modification of such condi- tions in each case, and the quantities produced of such pesticides. "SEC. 30. SEVERABILITY. "If any provision of this Act or the application thereof to any person or cir- cumstance .h:held invalid', the-invalidity shall 'not affect other provisions or ap- plications of this Act which can be given effect without regard to the invalid provision or application, and to this end the provisions of this Act are severable. -SEC. 3n AUTHORIZATION FOR" APPROPRIATIONS. ••There- is. authorized, to- be appropriated- such- sums as may be necessary to carry out the provisions of" this Act for each of. the fiscal years ending June .10: 197.1, June 30, 1974., and June 30. 1975: The amounts, authorized to be appropriated for any fiscal-year ending after June 30. 1975. shall be the sums, hereafter provided by law." Tierc i» hereby auxhorizcd to-be approprmted to carry out Use-provisions of Ais. Act -for the period beginning July J-H975. and 'ending September 30, 1975, the sum of SI 1,967,000. There is hereby authorized to be appropriated to carry out the provisions of this Act for the period beginning October 1,. 1975, and ending- November 15. 1975; thesum-of $5,983400. There are hereby authorized to be appropriated fo~"carry oufthe proviT stora of this Act for the period beginning- October 1. 1975. and ending September 30. 1976-. the sum ofS47.868.OfX), and for the period beginning October 1, 1976-. and ending-September 30. 1977, the sum of$46,636.000. .and for the period -October 1. 1977, and rending September 30. 1978. the sum of $54^00. OX»..antt for The period beginning October i; V978. and ending Septem- ber 30, 1979, such- sums as may be necessary, but not in excess of$70.000.000. There are hereby authorized to be appropriated tocarry out theprovisions of this Act for the period beginning October I, 1979, and ending September 30, 1980, such sums as may be necessary, but not in excess of 572,160,000, and for the period beginning October 1, 1980, and ending September 30, 1981, such sums as may be necessary, but not in excess of 777,500,000.". < FIFRA Compliance/Enforcement 1-44 Guidance Manual 1983 ------- Chapter One FIFRA Amendments to Other Acts Sec. 3. of P.L. 92-516 (1972) stales. The following Acts are amended by siriking out the terms "economic poisons" and "an economic poison" wherever they appear and inserting in lieu thereof "pesticides" and "a pesticide" respectively: (1) The Federal Hazardous Substances Act, as amended (15 U.S.C. 1261 et seq.); (2) The Poison Prevention Packaging Act, as amended (15 U.S.C. 1471 et seq.); and (3) The Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301 et seq.). Effective Dales of Provisions of Act Sec. 4. of P.L. 92-516 (1972), as amended, states, (a) Except as otherwise provided in the Federal Insecticide, Fungicide, and Rodenticide Act, as amended by this Act, and as otherwise provided by this section, the amend- ments made by this Act shall take effect at the close of the date of the enact- ment of this Act, provided if regulations are necessary for the implementation of any provision that becomes effective on the date of enactment, such regu- lations shall be promulgated and shall become effective within 90 days from the date of enactment of this Act. (b) The provisions of the Federal Insecticide, Fungicide, and Rodenticide Act and the regulations thereunder as such existed prior to the enactment of this Act shall remain in effect until superseded by the amendments made by this Act and regulations thereunder. (c)(l) Two years after the enactment of this Act the Administrator shall have promulgated regulations providing for the registration and classification of pesticides under the provisions of this Act and thereafter shall register all new applications under such provisions. (2) Any requirements that a pesticide be registered for use only by a certified applicator shall not be effective until five years from the date of enactment of this Act. (3) A period of five years from date of enactment shall be provided for certification of applicators. (A) One year after the enactment of this Act the Administrator shall have prescribed the standards for the certification of ap- plicators. (B) Each State desiring to certify applicators shall submit a State plan to the Adminstrator for the purpose provided by section 4------- Chapter One FLFRA CONGRESSIONAL RECORD: Vol. 117 (1971): Nov. 8. 9. considered and passed House. Vol. 118 (1972): Scpl. 26, considered and passed Senaie, amended. Oci. 5, Senaie agreed 10 conference report. Oci. 12. House agreed 10 conference report. WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS: Vol. 8, No. 44 (1972): Oct. 21. Presidential siaiement. P>Mto Ij- *4-l40 Mlk Co*«m3. H. R. U4I Notrmbrr Zl. I'15 HOUSE REPORTS: No. 94-497 (Comm. on Agriculture) and NO. 94-668 (Comm. of Conference). SENATE REPORT No. 94-452 (Comm. on Agriculture and Forestry). CONGRESSIONAL RECORD: Vol. 121 (1975). Sept. 26. Oct. 3, 9, considered and passed House. Nov. 12; considered and passed Senate, amended. Nov. 18, House agreed to conference report. Nov. 19, Senate agreed to conference report. PvMIc U» fllk C».t'm. S. 1*71 S»»H»tti 31. If 71 HOUSE REPORTS: No. 95-343 and No. 95-343, Pt. 2, (Comm. on Agriculture) both accompanying H.R. 7073 and No. 95-1560 (Comm. of Con- ference). SENATE-REPORTS: .No. 95-334 (Comm. on Agriculture. Nutrition and-Forestry) and 95-11*8 (Comm. of Conference). CONGRESSIONAL RECORD: Vol. 123 (1977): July 29, considered and passed Senaie. Sept. 22, Oct. 31, considered and passed House, amended, in lieu of H.R. 7073. Vol. 124 (1978): Sept. 18, Senaie agreed to conference report. Sept. 19, House agreed lo conference report. WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS: Vol. 14, No. 40: Oct. 2, 1978, Presidential statement. The following is Section 27(a) of P.L. 95-396, the "Federal Pesticide Act of 1978", but is not an amendment to FIFRA. 7 USt I36«.J Rcporl lo congressional commincc. Rcpon lo conprc\Mim; conimiiux. Studies Sec..21. ------- Chapter One 4 FIFRA Regulatory Elements FIFRA was enacted by Congress to provide for the pre-market clearance of pesticides and the post-market surveillance of pesticides and pesticidal devices. The following sections of this chapter discuss the primary regulatory means by which the Act is implemented. The primary regulatory elements of FIFRA include: • Registration of Pesticides; • Establishment Registration; # Pesticide Disposal; • Experimental Use Permits; « Emergency Exemptions for Federal and State Agencies; and • State Registration of Pesticides To Meet Local Needs. FIPRA Compliance/Enforcement1-47'Guidance Eternal 1983 ------- Chapter One FIFRA Regulatory Elements MJfKA tompl±ance/JSQ±orcement P58 Guidance Manual 1983 ------- Chapter One 4a Registration of Pesticides The basic element of EPA's pesticide regulation program is the registration of pesticides destined for use in the United States. Section 3 of FIFRA and 40 C.F.R. Part 162 provide the basic authority for the registration program. The objectives of the pesticide registration program are to: e Bring the product into compliance with Section 3 of the Act; • Provide users with pesticides that will not cause unreasonable adverse effects to the environment when used as directed; • Provide users with pesticides that will be effective for the pur- poses listed on the label; • Provide users with pesticides that are essentially safe when used as directed; • Identify the registrant and/or producer responsible for the pesti- cide ; and • Identify registered pesticides in the event that enforcement action is required. Applicability of Registration Requirements The Act requires that all producers (see Glossary) of pesticides have their products registered with EPA. With few exceptions, it is unlawful for any person in any State to sell, offer for sale, hold for sale, ship, deliver for shipment, or receive and (having so received) deliver or offer to deliver to another person any pesticide that is not registered. FIFRA Compliance/Enforcement 1-49 Guidance Manual 1983 ------- Chapter One Registration of Pesticides A pesticide may be registered by the Administrator if it is determined that: • The composition of the product warrants the proposed claims made for it; • Its labeling and other required material comply with the require- ments of the Act; • The product will perform its intended functions without unreason- able adverse effects to the environment; and • The product will not generally cause unreasonable adverse effects to the environment when used in accordance with widespread and commonly recognized practices. Registered pesticides will be classified as either "general" or "restric- ted," according to use. 'Pesticides Exempt 'From Registration Requirements The following pesticides are exempt from registration requirements under FIFRA [40 C.F.R. §162.5(b)j: • Pesticide products that are offered solely for human use and are also either a new drug within the meaning of the Federal Food, Drug, and Cosmetic Act or an article determined not to be a new drug by the FDA through a regulation establishing conditions for the article's use; • Pesticides being .transferred .from one registered establishment to .another registered -establishment operated ,by .the same producer solely for packaging at the second establishment or for use as a constituent part of another pesticide produced at the second estab- lishment; • Pesticides being transferred for use in accordance with the requirements of an experimental use permit; • *+ ,*efitieities-whose registrationis cancelled .under Section 6(c) of : tae .Act and .are shipped solely for disposal-; • Pesticide products Intended for export to any foreign country when prepared or packaged according to the specifications or directions of the foreign purchaser; and • Pesticides being transferred for use by a Federal or State agency under tbe provisions of :a. Section 18 .emergency exemption. FIFRA Compliance/Enforcement 1-50 Guidance Manual 1983 ------- Chapter One Registration of Pesticides Registration Procedures Types of Registration The following is a brief description and summary of the types of registra- tion and the general requirements for each type. Nev Registrations. The following must be filed with the Registration Division: * Application for Pesticide (EPA Form 8570-1); • Confidential Statement of Formula (EPA Form 8570-4); « Five copies of the proposed labeling; • Supporting data concerning product efficacy, general and environ- mental chemistry, and hazard, as required by 40 C.F.R. §162.8; • Offer-To-Pay Statement; • Certification Statement; • Statement proposing a classification of general or restricted use for the product; • Supportive data; and • Any other information required. NOTE: Filing an application does not constitute registration. Once a company files an initial application, it is assigned a permanent registrant number. This number, followed by a hyphen and letters is the file symbol. When and if the product is accepted for registra- tion, the file symbol is converted to the product registration number. Ex. Before Acceptance After Acceptance File Symbol EPA Registration Number 339-R 339-1 Amended Registrations. An application for amended registration must be submitted when changes are proposed in the labeling (such as the addition of new uses, change in product name, or request for additional brand names) or when minor changes are proposed in the formulation of the pesticide. The following must be submitted: • Application for Amended Pesticide Product Registration (EPA Form 8570-11); FIFEA Compliance/Enforcement 1-51 Guidance Manual 1983 ------- Chapter One Registration of Pesticides • Two draft copies of the proposed changes to the previously approved labeling with supporting data; and • Five copies of the final printed label in accordance with 40 C.F.R. §162.10, Labeling Requirements. Final printed labeling need not be submitted until after draft copies are approved by EPA. When a minor change in the product's chemistry is desired, the Confidential Statement of Formula (EPA Form 8570-4) should also be submitted. If the addition of a new use requires data, then two copies of this data should also be submitted. Distribution Under Amended Labeling After the effective date of a change in labeling or formula (the acceptance date), the product may still be marketed using the previously accepted label during the five-year registration period, unless the Registration .Division indicates- otherwise. Supplemental Registrations (Private Labels). A basic registrant's product can be supplementally registered for a distributor, thus allowing the distributor to market the product under his or her own brand name without a separate registration. Certain conditions are applicable for supplemental registration: • The distributor's product must have the same composition as the basic registrant's product; • The distributor's product must .be manufactured and packaged by the same person who manufactures and packages the registered basic product; • The product labeling for the distributor must bear the same claims as the basic product provided; however, specific claims may be deleted if by so doing no other changes are necessary; • The product must remain in the manufacturer's unbroken container; '=•• Ihe .iabel must iear..±he 2PA TegistTatiOTi-number of the tasic regis- tered product followed by a hyphen and the distributor's company number; and • The distributor's product must bear the name and address of the distributor, qualified by such terms as "Packed for...," "Distri- buted by...," or "Sold by...." FIFRA CoBpliance/Enforceaent1-52 Guidance Manual 1983 ------- Chapter One Registration of Pesticides The following should be submitted by the registrant: • Application for Supplemental Registration of Distributor (EPA Form 8570-5), which includes proof of concurrence by the distributor; and • Distributor's company number for each proposed distributor. Renewal Registrations.* Registration is effective for a period of five years from the date of registration. At the end of the registration period, a notice of intent to cancel will be sent to the registrant at the latest address known to the Registration Division. If a registrant wishes to continue the registration in effect after the expiration of the five- year registration period, a request for renewal registration must be made within 30 days of receipt of a notice of intent to cancel. If a continu- ance is not requested, cancellation of registration will become effective at the end of the 30-day period following receipt of the notice. Applications for renewal are subject to certain labeling and data require- ments. If the product or its labeling fails to comply with current requirements, the registrant will be afforded an opportunity to make the necessary corrections. Following receipt of a notice of intent to continue registration, the Registration Division may request specific data from the registrant. Re-registration. FIFRA Section 3(g) , as amended in 1978, directs EPA to re-register all currently registered products as expeditiously as possible. Central to the re-registration program is a document called a Registration Standard. Each standard summarizes all the data available to the Agency on a particular active ingredient and its current uses, and sets forth the Agency's position and requirements for a company to retain full registration. Once a standard is published, the Agency will solicit the appropriate registrants to re-register their products. Those registrants who wish to continue to sell or distribute their product in commerce must then meet the conditions and requirements of the standard. Although these requirements may vary from one active ingredient to another, in general they include: • Submission of needed scientific data that the Agency does not have; • Compliance with standards of toxicity, composition, labeling, and packaging; and • Satisfaction of the data compensation provisions. * The five-year renewal program is currently inoperative. FIFSA Compliance/Enforcement 1-53 Guidance Mgp"al 1983 ------- Chapter One Registration of Pesticides Conditional Registration. FIFRA Section 3(c)(7) authorizes the Administrator to conditionally register a pesticide product even though certain required data may not have been submitted or evaluated by EPA. A conditional registration is a registration for which the submission (or Agency review) has been deferred to a future date. Labeling Requirements ^^^ The registration program is designed to ensure that pesticide products will be safe and effective when used in accordance with statements listed on the label. FIFRA requires every pesticide product to bear a label containing the following: • Name, brand, or trademark under which the product is sold; • Name and address of producer, registrant, or person for whom produced; • Net contents statement; • Product registration number (EPA Reg. No.); • Producing establishment number (EPA Est. No.) (This number may be placed on the immediate container instead of the label.); • Ingredient statement; • Warning or precautionary statement; . *» Directions for use; and • Use classification. FIFRA Compliance/Enforcement 1-54 Guidance Manual 1983 ------- Chapter One 4b Establishment Registration Establishment registration is accomplished through application by a respon- sible company official to the Pesticides Group in the appropriate Regional Office of EPA. Registration is a formal procedure, and the firm should make written application to the EPA Regional Office having jurisdiction for the State in which the establishment is located. Foreign companies who wish to register their establishment with EPA should submit an application form to the Headquarters PTSOiS in Washington, B.C. The Regional Office or Headquarters will assign an establishment number. Each establishment will be assigned only one EPA establishment number. (In rare instances, an exception may be made when two separate corporate entities use the same facilities.) All pesticide products and active ingredients released for shipment in interstate commerce or released for export from or import into the United States must bear the establishment number. The establishment number must appear on the label or immediate container of all pesticide products. Authority Section 7 of FIFRA and 40 C.F.R. Part 167 require that establishments be registered with EPA before producing any pesticide product or active ingre- dient.* Section 25(c)(4) of FIFRA gives the Administrator authority "to specify those classes of devices which shall be subject to any provision of para- graph 2(q)(l) [misbranding] or section 7 [establishment registration]...." Proposed rules are under development for incorporating the term "active ingredient" under FIFRA §7 requirements. FIFRA Conpliance/Enforceiaent 1-55 Guidance Manual 1983 ------- Chapter One Establishment Registration Objectives The objectives of the establishment registration are to: • Identify the production site at which a pesticide, device, or active ingredient was produced; • Provide for more efficient production monitoring; • Identify the producer in the event that enforcement action is required; • Identify the production site in the event it is necessary to recall or stop sale of pesticides or pesticidal devices due to adverse effects to humans or the environment through accident, willful misuse, mishandling, or other adverse actions; and • Determine total quantities and types of pesticidal chemicals or devices introduced into the environment. Applicability of Registration Requirements All establishments where pesticides, devices, or active ingredients are produced must be registered except for those pesticides or devices not sub- ject to provisions of the Act or those active ingredients that are used to produce pesticides not subject to provisions of the Act. The term "produce" has been defined in the regulations as meaning "to manufacture, prepare, propagate, compound, or process any pesticide...including any pesticide produced for use pursuant to Sections 3, 5, 17, 18, or 24, or any active ingredient used in producing a pesticide or device." The term also means to repackage or otherwise change the container of any pesticide, active ingredient, or device. The following establishments are in this category and must be registered: • Producers who use active ingredients in making a pesticide; • Producers of technical material; • Formulators; • Repackagers; • Custom blenders; • Producers of pesticide products for export; FLFRA Conpliance/Enforceaent1-56Guidance Manual 1983 ------- Chapter One Establishment Registration e Foreign producers who export products to the United States; and e Producers of pesticides under experimental use permits. In addition, establishments that produce pesticides for other companies under a contract must also be registered. The establishment number of the actual producer must appear on all products. Registration Procedures Initial Registration EPA Form 3540-8, Application for Registration of Pesticide-Producing Establishments, must be completed and submitted to the appropriate Regional Office or to Headquarters. The Pesticides Group in each Regional Office or the Headquarters PTSCMS will review the applications. Applicants will be contacted by these offices when errors or omissions are apparent. Pesticide inspectors will be called upon, as necessary, to verify application information. Changes to Existing Registration Changes in company headquarters, ownership, or address (as identified in Item 2 of EPA Form 3540-8) must be reported within 30 days to the EPA Regional Office having jurisdiction over the State in which the company headquarters is located. Cancellation "or Revocation of Registration If a registered establishment no longer produces pesticides, the Regional Office should be notified to request cancellation of the registration, unless the firm intends to re-enter production at a later date. The registration of an establishment may be revoked for one of the following reasons: • Company request; • Failure of company to submit required reports; or e Registration due to administrative or other error. An establishment registration may not be revoked or terminated for viola- tions of other requirements under FIFRA. Civil or criminal penalties are applied for other violations and the establishment registration remains in effect. FIF2A Cojapliance/Enforceiaent 1-57 Guidance M?nna1 1983 ------- Chapter One Establishment Registration Establishment Registration Numbers The EPA Regional Office or PTSCMS will assign an establishment number to applicants. The numbering system is based on the company registrant number, the abbreviation for the State in which the establishment is located, and a sequential number for each establishment registered by that company within the State. Placement on Label or Container The establishment number preceded by "EPA Est." must appear on all pack- aging and containers as follows: Example: EPA Est. 777-KY-3 That number is to be the one assigned to the last establishment at which the product was produced or repackaged. No combinations of product regis- tration and establishment numbers will be permitted. The establishment number may appear anywhere on the pesticide container or on the label. It must also appear on the outside container or wrapper of the package if it cannot be clearly read on the immediate container. The establishment number is to be used in addition to and not in lieu of the product registration number. Both the establishment number and the product registration number must appear on the product released for ship- ment. The establishment number may be on either the label or the immediate container, while the product registration number must appear on the label. Producers may seek approval of various techniques or formats for displaying the establishment number. If the company obtains approval to include more than one establishment number on a label, the producing establishment for the labeled product must be marked, notched, or otherwise clearly noted thereon for identification purposes. Following are examples of approved formats that may be adopted for use by pesticide producers. • Example 1. The company (registrant) number is 123, and there are three registered establishments—two in Indiana (IN) and one in Massachusetts (MA). The three establishment numbers are printed in full. Those products produced at the second site in Indiana may be identified by a saw-cut, notch, arrow (as shown), or similar indicator. EPA Est. 123-IN-l 123-IS-2 < 123-MA-l FIFRA Cottpliance/Eaforceraent 1-58 Guidance Manual 1983 ------- Chapter One Establishment Registration e Example 2. The company (registrant) number is followed by the State abbreviation and the digit(s) of the establishment(s) located in that State. When another State is introduced, the company number need not be repeated. To indicate the actual production site, the establishment digit may be identified by a saw-cut, notch, arrow (as shown), or similar indicator. This example shows a product produced at the second site in Indiana. EPA Est. 123-IS-l-2<: MA-1. • Example 3. The producer is adding its own code number to identify the actual production site. Each of the three establishment numbers on the label will be followed by a. code; a statement following the numbers will explain that the inspector must look on the bottom of the container to determine the actual producing establishment.. EPA Ect. 123-1::-1, 2: K&.-1 See last letter on bottom of can for actual establishment. Other variations must be approved by Headquarters PTSCMS. (In no case may the establishment number be combined with the product registration number.) Establishment Production Reports Each producer must submit an annual report of pesticide production to include activities relating to: o Manufacture; - - - - - e Formulation; « Repackaging; • Export and import; • Experimental use; • Special local needs of States; and • Federal and State emergency exemptions. Producers who manufacture their own products and serve as distributors of other products must report only their own production. Distributors and sellers need not report if they are not producers. Also, any person who is a producer solely because he or she produces a custom-blended pesticide need not report. FIFEA Compliance/EujJorceEisnt 1-59 Guidance Manual 1983 ------- Chapter One Establishment Registration Each establishment must have its own report and may not be combined in the case of one company having several establishment locations. However, the company headquarters may complete the forms. When To Report Reports from all registered establishments must be submitted annually, by February 1, to the Regional Office having jurisdiction over the State in which the establishment is located. The original and one copy of the form are to be submitted. When a new establishment is registered, a pesticides report must be sub- mitted to the Regional Office or to Headquarters within 30 days after notification of registration. A pesticides report form (EPA Form 3540-16) will be furnished to the producer with the assignment of the establishment. number. What To Report Only those products actually produced at the reporting establishment should be included. Information on products sold or distributed by, but not pro- duced at, the reporting establishment is not to be included in this report. Products produced under several distributor numbers are to be reported as one product under the basic product number and using the registered product name. The Annual Production Report Form is used to prepare the annual report. Information required for the report includes: • Establishment name and address; • Establishment number; • Listing of each pesticide product or device produced; • Pesticide registration number; • Product name; and • Chemical formulation, if the product or device: - Is not registered with EPA or the State, - Does not have registration applied for, - Is produced under an experimental use permit, or - Is an unregistered technical material shipped under a Section 3b exemption. FIFRA Conpliance/Enforcement 1-60 Guidance Manual 1983 ------- Chapter One Establishment Registration Confident ialit" Section 7(d) of FIF2A provides that any information submitted by industry to EPA pursuant to an establishment registration application will be con- sidered confidential and subject to the provisions of Section 10 (Protection of Trade Secrets and Other Infomatior.) of the Act. Section 12(a)(2)(D) of FIFRA provides that it is unlawful for any person "to use for his own advantage or to reveal, other than to the Administra- tor, or officials or employees of the Environmental Protection Agency or other Federal executive agencies, or to the courts, or to physicians, pharmacists, and other qualified persons, needing such information for the performance of their duties, in accordance with such directions as the Administrator may prescribe, any information acquired by authority of this Act which is confidential under this Act." In addition, Section 10(f) provides that any past or present officer or employee of the United States who willfully discloses confidential information subject to Section 10(b) to any person not entitled to receive such information shall be fined not more than $10,000, or imprisoned for not more than one year, or both. (See Chapter Eleven for specific information concerning confidentiality procedures.) FIFRA CoEipliance/Eiiforcecient 1-61 Guidance Manual 1983 ------- Chapter One ^ Establishment Eeglstration FIfRA Compliance/Enforcement1-62Guidance Manual 1983 ------- Chapter One p I •ticido Uiso^. Authority Under Section 19 of FIFRA, the Agency has the authority to issue procedures and regulations for the disposal and storage of excess pesticides, pesti- cide containers, and pesticide-related wastes. Because of certain informa- tion gaps and a nationwide shortage of safe disposal facilities, the Agency has issued guidelines and recommended procedures for the disposal and storage of pesticides as the first step in fulfilling its mandate to regu- late the disposal of pesticides (39 Fed. Reg. 15236, 40 C.F.R. Part 165). As a second step, the Agency intends to promulgate a set of regulations that prohibit the "worst acts" of pesticide disposal and storage and, even- tually, to proiuulgate comprehensive regulations for the disposal and storage of pesticides. Enforcement Actions and Disposal Practices Section 19 Regulations and Recommended Procedures The procedures for disposal and storage of excess pesticides, pesticide containers, and pesticide-related wastes, promulgated pursuant to Section 19 (40 C.F.R. §165.7 et seq.), are merely recommended procedures and do not carry the force of law. While all persons or parties should be encouraged to follow the Section 19 guidelines, no enforcement action will be taken against those who do not adhere to the guidelines. Nonetheless, it is unlawful to dispose of pesticides in a manner inconsis- tent with the label directions for disposal [Section 12(a)(2)(G)] unless the person is following these Section 19 procedures. However, pursuant to Executive Order 11752 (38 Fed. Reg. 34793), compliance with the Section 19 recommended procedures for the disposal and storage of pesticides is mandatory for all Federal agencies. FIFEA Cottpliance/Eiiforcer^Et 1-63 Guidance Manual 1983 ------- Chapter One Pesticide Disposal Transportation of Unregistered Pesticides for the Purpose of Disposal Although the shipment of an unregistered pesticide is an unlawful act pur- suant to Section 12(a)(l)(A), the Agency has interpreted Section 19 as authorizing the Eovement: of such pesticides for the specific purposes of disposal or storage (38 Fed. Reg. 15237). Thus civil or criminal penalties will not be imposed upon persons shipping unregistered pesticides to dis- posal sites. In the event that there is some question as to whether unregistered pesticides are actually being shipped for disposal, regional enforcement officers should make inquiries to confirm that such shipments are for the purpose of disposal. If satisfactory evidence is not available to show that the unregistered pesticides were actually being shipped for disposal or if routine investigation does not corroborate the owner's claim of ship- ment for disposal, a civil complaint or a civil penalty warning citation may be issued as appropriate. The person cited may then offer evidence in a settlement conference or plead as an affirmative defense in a civil penalty hearing that the unregistered pesticides were actually being shipped for disposal. The regional enforcement personnel should encourage those persons interested in shipping unregistered pesticides to disposal sites to notify the Regional Office in advance of such shipments. FIFRA CojapHance/Enforceaent 1-64 Guidance Manual 1983 ------- C}_ _ ^ i ^ ,.. i I C. K' L C-: i Fv n^'innpntpi! 1 !^^ pprrnit I /\ i.J >_': i i I i O i i L C". i W «^,' v^/ i t? I I I i i L O Authority Section 5 of FIFRA and 40 C.F.R. Part 172 provide the Administrator with the authority to issue an experimental use permit in order for an applicant to accumulate information necessary to register a pesticide under Section 3 or to secure information for a new use of a registered pesticide. The Administrator may revoke any experimental use permit: (1) if it is found that the terms or conditions are being violated; (2) if its terms or conditions are inadequate to avoid unreasonable adverse effects to the environment; (3) if new evidence is obtained which demonstrates that the tolerance will be inadequate to protect the public health; or (4) for failure to meet"any provisions of 40 C.F.R. Part 172. Scope The regulatory provisions of FIFRA for experimental use permits do not apply to tests to determine the purpose, toxicity, or properties of a pesticide, where the tester does not expect to receive any benefits from the use of the pesticide. Permit Application Procedures An application (EPA Form 8570-17) for an experimental use permit must be submitted in triplicate to the Registration Division of the Office of Pesticide Programs. The contents must include: e Names and addresses of applicants, participants, and cooperators; « Registration number of product, if registered; • Proposed method of storage and disposal; FIFEA Compliance/Enforcement1-65Guidance Manual 1983 ------- Chapter One Experimental Use Peraits e Proposed objective and purpose of testing; e Factors relating to testing program; and • Tolerance data. For an unregistered pesticide product, the application must also include: • Confidential statement of composition; • Chemical and physical properties of active ingredients; • Data of the rate of decline of residues on treated crop or environ- mental site or other data regarding entry into treated areas; and • Results of toxicity tests. The permit will be issued upon the determination by the Administrator that the statutory and regulatory provisions of Section 5 have been met. The permit .will specify the conditions, duration, and recordkeeping require- ments . Labeling Requirements All pesticides shipped or used under an experimental use permit must be labeled with the following (40 C.F.R. §172.6): • The statement "For Experimental Use Only"; • Permit number; • The statement "Not for sale to any person other than a partici- pant or cooperator of the EPA-approved experimental use program"; • Name, brand, or trademark; • .Name and address of the permittee, producer, or registrant; • Net contents; • Ingredient statement; • Warning or caution statement; <• Limitations .on entry into treated areas; • Establishment registration number, if appropriate; and • Directions for use. FURA Compliance/Rnforceiaent 1-66 Guidance Manual 1983 ------- Chapter 4e Emergency Exemptions for Federal anc! State Agencies Under Section 18 of FIFRA the Administrator has the authority to exempt Federal and Sta.te agencies from the requirements of the Act under the following emergency conditions: e A pest outbreak has or is about to occur and no pesticide regis- tered for the particular use, or alternative method of control, is available; c Significant economic or health problems would occur without the use of the pesticide; or e There is insufficient time to register a pesticide before the dis- covery or prediction of a pest outbreak. Types of Exemptions Specific "Exemption A specific exemption may ba granted to control the outbreak of a pest in the United States and is valid only for the specific situation involved. Exemption conditions may include: « Limitation on quantity of pesticide used; • Conditions under which it may be applied; • Persons who may apply the pesticide; • Monitoring activities; and e Duration of exemption (never longer than one year). FIFSA CoT-Tjliance/Enforce-szit 1-67 Guidance Manual 1983 ------- Chapter One Emergency Eseaptioas for Federal and State Agencies Quarantine/Public Health Exemption A quarantine or public health exemption may be granted to prevent the introduction or spread of a foreign pest .into or throughout the United States. Exemption conditions include: • Duration of exemption (never longer than one year, although the Administrator may renew the exemption); and • No pesticide may be used that has been suspended by the Administrator. Crisis Exemption Crisis exemptions are granted to any Federal or State agency in situations involving the unpredictable outbreak of pests in the United States where the responsible official in authority determines: • There is no readily available pesticide registered for the parti- cular use; and • The time element is too critical to request a specific exemption. Procedures To Be Followed Specific Exemption Upon approval of a specific exemption, the Federal or.State agency must: • Immediately inform the Administrator in writing of the time and place of pesticide application; • Inform the Administrator of the location, quantity, and extent of use of the pesticide within 10 days of final application or use; • Initiate monitoring activities specified by the exemption and report .any...adverse effects .to -the ..Agency; and • Provide the Administrator with a summary report on the emergency action taken and the outcome of such action within one year of the ~~ granting of the exemption. FUEA ConpHance/Enforceraent Manual 1-68 Guidance Manual 1983 ------- Chapter tee Esvsrccenc;? Sxe-yptloii;-: for ^ecerzJL and State Agencie."-; Quarantine/Public health Exemption The Federal or Stats agency using or applying pesticides under this exemp- tion mus t: c Maintain records of all treatments including: - Application site, - Pesticide used, - Rate of application, and - Quantity used; and « Submit to the Administrator and the Hearing Clerk of the Agency, one month after the expiration of the exemption, a report listing: - Number of treatments, - Pesticides used for each type of treatment, and Steps taken to comply with registration requirements of the Act. Crisis Exemption When a Federal or State agency determines that it will avail itself of a crisis exemption, the head of the Federal agency or the Governor of the State or their designees must notify the Administrator by telegram within 36 hours of this determination. Within 10 days of the application for use of the pesticide, they must file with the Administrator the following certified information: o The nature and scope of the emergency, including the pest involved; c That no pesticide registered for the particular use was readily available, and the basis for such determination; o That the time element was too critical to request a specific or quarantine/public health exemption; o The location, quantity, method of application, duration of applica- tion, and qualifications of personnel involved in the application; • The steps being taken to reduce adverse effects; and • Any other information requested by the Administrator. FIFSA Compliance/Enforcement iianusl 1-69 Guidance Manual 1983 ------- Chapter One Eaergency gserrpticus for Federal, and State Agencies Withdrawal of uceraDtion The Administrator will withdraw an exemption upon determination that: • An agency is not complying with the requirements of the exemption; or • Such action is necessary to protect humans or the environment. FIFSA Coinpliance/Enforcement 1-70 Guidance Mgji"*1 1983 ------- 1--. /— •»—. * /"• -"• i'*~"\ -•-. -v I I d p I o- i L/' i i c: - O f '"'> "!" /"N D <~\ r~*' i o -•• " s~^ ^ : /*^ ^ /~\ -f D /^\ o 4- 1 /~* i /H /~> i olaic-' ndCiiSii airo: i ui r6SIiG!Q6. Under Section 24(c) of FIFIL's, a State is authorized to register a new end use product for any use, or additional use of a federally registered pesti- cide ., Conditions for Section 2Iiaxica/:i-afcrcaua-at 1-71 Guidance Kanual 1983 ------- Chapter One State Se-^rlstratioa of Pesticides e Any use of a federally registered product for which registration of other uses of the product was denied, disapproved, cancelled, or suspended; and • Any use of a federally registered product for which registration of some or all uses has been voluntarily cancelled by the registrant. State-issued registrations for new products are based on the following pro- duct criteria: • A product identical in composition to a federally registered pro- duct but different in packaging or identity of the formulation; • A product that contains the same active and inert ingredients as a federally registered product, but in different percentages; and e A product containing a new combination of active or active and inert ingredients if each active or inert ingredient is contained in a federally registered pesticide. Registration Disapproval/Suspension General Disapproval State registrations that do not have a composition .and use pattern which is similar to federally registered pesticide products may be disapproved by the Administrator if there are reasonable grounds. Special Disapproval The Administrator may disapprove any State registration, including a regis- tration for a similar product if it is determined that the use of the pro- duct: • Would constitute an imminent hazard; or • May result in a residue on food or feed exceeding or not covered by a tolerance, exemption, or other clearance under the Federal Food, Drug, and Cosmetic Act. Suspension The Administrator may suspend all or any part of a State's authority to register pesticides under Section 24(c) if the State: • Is not capable of exercising adequate pesticide controls; or e Has failed to exercise adequate pesticide controls. FIFEA Compliance/Eafcrceiiani1-72 Guidance Manual 1983 ------- Chaoier One O Q ;••" \ / o ci; y ACT — When used in this manual, "the Act" means the Federal Insecticide, Fungicide, and Rodenricide Act, as amended (FIFRA)- ADMINISTRATIVE LAW JUDGE — An Administrative Law Judge appointed pursuant to 5 U.S.C. §3105 (see also 5 C.F.R. Part 930, as amended by 37 Fed. Reg. 1678S). ADMINISTRATOR — The Administrator of the Environmental Protection Agency. ADULTERATED — A pesticide is adulterated if: — Its strength or purity falls below the professed standard of quality as expressed on its labeling under which it is sold; — Any substance has been substituted wholly or in part for the pesti- cide; or — Any valuable constituent of the pesticide has been wholly or in part abstracted. AFFIDAVIT — A written statement made on oath before a notary public or other person authorized to administer oaths. AGEKCY — The United States Environmental Protection Agency (SPA). BATCH — A quantity of a pesticide product made in one operation or lot or if made in a continuous or semi-continuous process or cycle, the quan- tity produced during an interval of time to be determined by the producer. BIN LABELS — Stock supply of labels that have not been affixed to the product containers. BOOKS AND RECORDS — All records required pursuant to Sections 8 and 9 of the Act and 40 C.F.R. §169.2 and all records in lieu thereof. CERTIFIED APPLICATOR — Any individual who is certified under Section I* as authorized to use or supervise the use of any pesticide that is clas- sified for restricted use. FIFRA Compliance/Enforcement 1-73 Guidance Manual 1983 ------- Chapter One Glossary CIVIL ADMINISTRATIVE COMPLAINT — A written communication alleging one or more violations of specific provisions of the Act or regulations promulgated thereunder (40 C.F.R. §22.03). Each complaint shall include: (1) reference to the provisions of the Act alleged to have been violated; (2) a concise factual statement of the violation; (3) the amount of the proposed penalty; (4) a statement of the appropriateness of the penalty; (5) notice of the respondent's rights to an adjudicator}' hearing; and (6) a statement reciting the section(s) of the Act authorizing the issuance of the complaint (40 C.F.R. §22.14). COMMERCIAL APPLICATOR — A certified applicator (whether or not he or she is a private applicator with respect to some uses) who uses or super- vises the use of any pesticide that is classified for restricted use for any purpose or on any property other than as provided by the definition of "private applicator." COMPLAINANT — Any person authorized to issue a complaint on behalf of the Agency to persons alleged to be in violation of the Act (40 C.F.R. §22.03). CONSENT AGREEMENT — Any written document containing stipulations of fact; conclusions regarding material issues of law, Fact, or discretion; and a specified proposed penalty acceptable to both complainant and respondent that results from any settlement conference (40 C.F.R. §22.18). COOPERATOR — Any person who grants permission to a permittee or a permit- tee's designated participant for the use of an experimental use pesti- cide at an application site owned or controlled by the cooperator. CUSTOM BLENDED PESTICIDE — A pesticide that meets the following conditions: — The blend contains only registered pesticides, fertilizers, and inert ingredients; — Each pesticide used in the blend bears end-use labeling directions providing for use of the product in such a blend, or the blend is recommended in writing by an appropriate State or Federal agency official; — The blend is produced to the order of the user; — The blend is not held in the inventory; and — The blend is delivered to the user with a copy of the end-use labeling of the pesticide(s) used in the blend and a statement specifying the composition of the mixture. FIFBA Compliance/Enforcement 1-74 Guidance Manual 1983 ------- DEFAULT C?,DIIl — An order issued pursuant to 40 C.F.R. §22.17 disposing cf a natter cf cor "re •-•arsy b-;f.'--e~n respondent and the Agency upon (1) the failure of respondent to file a timely answer to the complaint; (2) the fs.ilu.re of one cf the. parries to comply vith a prehearir.g or hearing order of the Presiding Officer, or (5) the. failure of one cf the parties to appear at a conference or hearing without good cause being shown. DEGRADATION PRODUCT — A substance resulting from the transformation of a pesticide by physical', chemical, or electromagnetic means. DEVICE — Any instrument or contrivance (other than a firearm) that is intended for trapping, destroying, repelling, or mitigating any pest or other form cf plant or animal life (other than humans and other than bacteria, viruses, or other microorganisms on or in living humans or other living animals); but not including equipment used for the application of pscticicas when sold separately therefrom. DISTRICT COURT — A United States district court, the District Court of Guam, the District Court cf the Virgin Islands, and the highest court of American Samoa. DRIFT — Movement of a pesticide through the air (during or immediately after application or use) to a site other than the intended site of application or use. EFFICACY — The capacity of a pesticide product v;hen used according to label directions to control, kill, or induce the desired action in the target pest. ENVIRONMENT — Includes water, air, land, and all plants, humans and other animals living therein, and the interrelationships that exist among these. ESTABLISHMENT — Any place where a pesticide or device is produced cr held for distribution or sale. FINAL ORDER — An order issued by the Administrator after an appeal of.an initial decision, accelerated decision, decision to dismiss, or default order disposing of a matter in controversy between the parties or an initial decision under 40 C.F.R. §22.27(c). GENERAL USE PESTICIDE — A pesticide, when applied in accordance with its directions for use, warnings and cautions and for the uses for which it is registered, or for one or more of such uses, or in accordance with a widespread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environment. HEARING — A hearing open to the public provided in Section 14(a)(3) of the Act and conducted pursuant to the provisions of Chapter 5, Subchapter II of Title 5 of the United States Code, and the rules of practice found at 40 C.F.R. Part 22. FIFSA Coiaplifaj.ceyli2fo"c-c-:,ir-t " 1-75 Guidance Kanual 1983 ------- Chaster One Glossar- HEARING CLERIC — The Hearing Clerk, United States Environmental Protection Agency, Washirgton, D.C. 20460 . IMMINENT HAZARD — A situation that exists when the continued use of a pesticide during the tise required for cancellation proceeding would be likely to result in unreasonable adverse effects on the environment or will involve unreasonable hazard to the survival of a species declared endangered by the Secretary of the Interior pursuant to the Endangered Species Act of 1973. INERT INGREDIENT -- An ingredient that is not active [FIFRA §2(m)]; or, all ingredients that are not active ingredients as defined in 40 C.F.R. §162.3(c), and includes, but is not limited to, the following types of ingredients (except when they have pesticidal efficacy of their own): solvents such as water; baits such as sugar, starches, and meat scraps; dust carriers such as talc and clay; fillers; wetting and spreading agents; propellents in aerosol dispensers; and emulsif iers . INITIAL DECISION — -The decision issued by the. Administrative Law Judge based -upon the 'record of the hearing out of which the decision arises or upon the rendering of an accelerated decision. The decision is suppor- by findings of fact and conclusions regarding all material issues of law, fact, or discretion. This decision will become the final decision and order of the Administrator without further proceedings unless the decision is appealed or the Administrator orders a review of the case. INSPECTOR. — Any officer or employee of the Environmental Protection Agency or of any State duly authorized by the Administrator to conduct inspections, make investigations, collect samples, and otherwise carry out the provisions of the Act. Such person may also be known by such designations as Consumer Safety Officer, Pesticide Inspector, Accident Investigation Officer, Compliance. Officer, etc. JUDICIAL OFFICER — An officer or employee of the Agency designated as a judicial officer who shall meet the qualifications and perform functions provided for in 40 C.F.R. §22.04. LABEL — The written, printed, or graphic matter on or attached to the pesticide or device or any of its containers or wrappers. XABELING — All labels and .all other written, printed, or graphic matter accompanying the pesticide or device at any time or to which reference is made on the label or in literature accompanying the pesticide or device [See Section 2(p)(2)(B) of the Act for exceptions]. MARKET PLACE — All places other than production sites where pesticides or devices are held for distribution or sale. mSBRANDED — A pesticide is nis"branded if: — Its labeling bears any statement, design, or graphic representation, relative thereto or to its ingredients, that is false or misleading. FIFRA Compliance/E^^orcenent 1-76 Guidance Manual 1983 ------- Chapter Or.:- Glc sr <-•_-•. ::cir. _r container or wrapping that coe; .s G-rfared r.r sa_e under the narae cr , — Its lab.4:1 dees not beer -he establishment registration number. — Any required information on the label or labeling is not prominently and conspicuously placed. — The accompanyi^ labeling does not contain directions for use that are necessary for effecting the purpose for which the product is intended, — The label dees no:: contain a required Darning or caution statement , —. The label d :e:: r.ct bear an ingredient statement on that part of the immediate container that is displayed under customary conditions of purchase. The ingredient statement mu?t also appear on any outside container cr wrapper that conceals ths statement on the immediate container. (The product is net r.isbranded if its size and form c;?.l:e such placement impracticable ar.d if EPA peraits placement elsevhera on the ix™ediata container cr outside container or wrapper.) — The labeli-;^; doe? net contain a statement of the use classification under which the product is re^lrtered» — There is ••.o label on the ir;:::ediate cor.tr.iner or concealing wrapper bearing: fi The licuie and ^dcre.:c c'? the producer, registrant, or person fci whorj produced ; s The nane, brand, or trf-demark under which the pesticide is a The net ve.vrht er aeacure of the content ; and e The required registration number and use classification. — The pesticide is highly toxic to humans ana the label does not bear: e The skull and crossbones ; « The word "poison" prominently in red on a background of dis- tinctly contrasting color; and o A statement of practical treatment (first aid or otherwise) in case of poisoning by the pesticide. MISUSE — Use of registered pesticide ir; a manner not permitted by its labeling [see Section 2(ee) of the Act for exceptions], A ""Csupiianca/Z-iforcev-siit l-7~7 Guidance Manual 1983 ------- Cnauter C-e Glossa— NOTICr, OF JUDGMENT — A written notice of all judgments entered in actions instituted under the authority of the Act and includes civil, criminal, and seizure actions. PACKAGED, LASHED, A27B RELEASED FOR SnlP^ENT — The term, "packaged, labeled, and released for shipment" defines that point in the producing- Earketing process of a pesticide when (1) the product has been produced and (2} it is the intent of the producer that such product be introduced into commerce. At the producer establishment level, such intent to introduce the pro- duct into tne channels cf trade (release for shipment) may be evinced by any of the following factors: — The producer's assertions that what is being sampled is representa- tive of what is actually sold; — The storage of the product in areas, such as loading docks, ware- houses, or other areas where finished products are held for shipment in the ordinary course cf business; — The custom of the pesticide chemical industry indicates that similarly situated products- are intended for release; or — The custom of the particular producer indicates that similarly situ- ated products have in the past been intended for release. Although there is a strong presumption in the situation in which a product is "intended for release" that the product has been "released for shipment," it is within the inspector's discretion to entertain a producer's assertion that under the particular circumstances such product was not intended for introduction in.to .commerce. At the distribution and retail establishment levels, products have been "released for shipment" at an earlier time by the producer establishment and, therefore, are subject to inspection and sampling as finished products. PARTICIPANT — Any person acting as a representative of the permittee, and responsible for making available for use, or supervising the use or evaluation of, an .experimental -use pesticide to :.be applied at a specific application site. PARTY — Any person, group, organization, agency, or department that parti- cipates in a hearing as complainant, respondent, or intervenor. PERMITTEE — Any applicant to whom an experimental use permit has been granted. TERSO'N — Any individual, partnership, association, corporation, or any organized group of persons whether incorporated or not. FIFKA Compliance/anforcement 1-78 Guidance Manual 1983 ------- as bsin;; inj jri cj.- t: he-£.'_:?: cr v.':-.-'ix-cnc:£:.i. PESTICIDE — Any substance or r:i::tur£. of substances intended fcr preven- ting, destroying, repelling, or -litigating any pest, or any substance or mixture of substances intended, for use as £ plant regulator, defoliant; _, or dessicant. PESTICIDE FORMULATION: — The substance or mixture cf substances comprised of all active ar.d inert (if any) ingredients of a pesticide product. PESTICIDE P-lOZxCT -- A pesticide offered as a commercial product, conplete viith c-ctiv- ?.-.:! i;..::::. (:'.:: arij'-) it gradients, in a container having a label , a:;d any labeling. PETITIONER — Any p-rs;cx: f..rver~ •;.!;•. affc.cu^d by a notice of the PRESIDING C7riCZ;.l — Th= Ad^iriistrativs L?T; Judge designated by the Chief Adainistr?tive La1,? Judge to serve as the Presiding Officer of an admin- istrative hsaring arising cj.r cf the Act, PRIVATE APPLICATOR — A certified applicator v.-ho uses or supervises the usn of any pesticide classified for restricted use for purposes of producing any agricultural coiracdity en property cvmad•or rented by the applicator or tb.e applicator's employer or (if applied without compensation ocher than trading of personal services betveen producers or agricultural coiunoditie;} on the property cf mother person. FR.ODUCE — To Eanuf actura, prepare, propagate, compound, or process any pesticide, including any pesticide produced fcr use pursuant to Sections 3, 5, 17, 18, or 24, or any active ingredient used in producing a pesti- cide or device. The terra also neans to repackage or otherwise change the container cf any pesticide, active, ingredient, or device. "Produce" does not mean to d.ilute, nix, or blend a registered end-use pesticide for personal use according to label directions, or as allowed by Section 2(ee) of the Act. PRODUCER — Any person who produces any pesticide, device, or active ingredient. PROGRAMMED INSPECTION — An inspection requiring the selection of a speci- fic program activity that is subject to routine compliance monitoring and results from an enforcement strategy based upon objective selection cri teria. REGIONAL ADrill'ISTHATCa —• The Administrator (or delegate) of a Regional Office of the Agency. Cor,:pli<.u.ce/£o.force: irit 1-79 Guidance lianual 1933 ------- Charter Cr:e Glossar REGIONAL tZARING CLERK — An individual duly authorized by the Regional Administrator tc serve as hearing clerk for a given Region. Correspon- dence i^ay be addressed to the Regional Hearing Clerk, United States Environmental Protection Ager.cy (address of Regional Office). REGIONAL JUDICIAL. OFFICE?. — Ac officer or employee of the Agency duly authorized by the Regional Acninistrator to serve as the Judicial Officer for the Region as provided in the Consolidated Rules of Practice (CROP). REGISTRANT — A person who has registered any pesticide pursuant to the provisions of FIFRA. RESIDUE — The active ingredient(s), metabolite(s) , or degradation pro- duct (s) that can be detected in the crops, soil, water, or other component of the envircau:ynt (including husans), following the use of the pesticide. RESPONDENT — Any person proceeded against in a complaint. RESTRICTED USE PESTICIDE — A pesticide that when applied in accordance with its directions for use, warnings and cautions and for the uses for •which it Is registered, or for one or more of such uses, or in accordance with a widespread and commonly recognized practice, nay generally cause without additional regulatory restrictions, unreasonable adverse effects en the er_vironn;.er;.t:. SPECIAL LQ.CAL .TEED — A pes_ vroblca (existing or imminent within a State) that cannot be effectively controlled because an appropriate EPA- registered pesticide product; is not available. UNDER .THE .DIRECT SUPERVISION 0? A CERTIFIED APPLICATOR — Unless otherwise prescribed by its Labeling, a pesticide shall be considered to be applied under the direct supervision of a certified applicator if it is applied by a competent person acting under the instructions and control of a certified applicator who is responsible for the actions of that person and who is available if and when needed, even though such certi- fied applicator is not physically present at the time and place the pesticide is applied. ONPROGRAMMED .INSPECTION ("Fox Cause" Inspection) — An. inspection .in which •prooable violations of the Act are observed or brought to the attention of the Agency through, for example, an employee's complaint or a compe- titor's tip. USE — Any act of handling or release of a pesticide, or exposure of humans or the environment to a pesticide through acts, including but not limited to: — Application of a pesticide, including mixing and loading and any required supervisory action in or near the area; FIFEA CoiapliaGce/Enforce^erit1-80 Guidance Manual 1983 ------- —— i_>cc~cir.i rcti.'^T'i.?. I*"..' ~ •-s t.-, c~c 5 £ C.T-C ocsc2.cr.c2 containersr and — Di£pos;:.l act:! or.£ for pesticides a-od pesticide containers. Use £: dsf J-Zi :! l.^rc. ir.corpcrs.tes applicetic.n. However, the ccrtificc- tior. r?.c:ui:'i--.^r.t for certain restricted use pesticides only applies vfi respect to £7-pIica.tior.« of such pesticides. Many aspects cf use do r.c include application (e.g., storage cr transportation), and hence are outside the requirersnt for certification. FIFIIA (kiiiplicence/Znforci:..ii:t 1-&1. Guidance Manual 1983 ------- Glcsscr- FIFSA Compliance/liif or octant 1-8; Guidance Manual 1983 ------- Chapter Two General Operating Procedures Chapter Contents Page Primary Office Responsibilities 2-1 Concurrence Procedures 2-5 State and Federal Interagency Cooperation 2-5 Organizational Charts 2-9 FIFEA Goopliance/Enforceaent 2-i Guidance Mamml 1983 ------- Chapter Two Contents Manual 1983 ------- Chapter Two General Operating Procedures Primary Office Responsibilities The basic framework setting forth the responsibilities of each EPA office participating in enforcement activities was established by the Adminis- trator's memorandum of July 6, 1982, entitled "General Operating Procedures for the Civil Enforcement Program" (GOP). (See EPA's General Enforcement Policy Compendium*) This chapter describes the respective roles and rela- tionships of the various EPA offices that are involved with FIFRA enforce- ment. EPA's enforcement program includes both compliance-oriented and legal- oriented activities. The compliance-oriented activities are primarily the responsibility of EPA's program offices, and the legal-oriented activities are principally charged to the Office of Legal and Enforcement Counsel (OLEC), Including the Regional Counsel. Because many enforcement activi- ties involve several aspects, these activities cannot be defined as strictly "compliance" or "legal." Where both elements are present, the EPA attorney must be especially diligent in coordinating the legal aspects with the functions of the other participating offices. The basic relationship between the attorney and the program office is that of attorney-client. The basic enforcement functions are divided among the participating offices as follows: Regional Administrator Program Office • Identifies Instances of noncompllance; • Establishes priorities for handling instances of noncompliance; • Evaluates the technical sufficiency of actions designed to remedy violations; fJfSA Compliance/Enforcement 2-1 g^^fn^m Manual 1983 ------- Chapter Two General Operating Procedures • Identifies for formal action those cases that cannot be resolved less formally; • Provides technical support necessary for developing cases and con- ducting litigation; • Issues written notices of warning; • Issues stop sale, use, or removal orders; • Cooperates with district courts in -the disposition of condemned pesticides or devices;* • Issues routine civil administrative complaints; • Evaluates the appropriateness of civil penalties;* and • Negotiates and prepares consent agreements memorializing settle- ments' between the Agency and respondents prior to the alleged vio- lator's filing of an answer or falling to file an answer to a com- plaint.* Regional Counsel • Acts as attorney for "client" program offices; • Assists program office in drafting or reviewing notices of warning, administrative orders, or administrative complaints; • Ensures consistency of action with OLEC guidance; •.--•«• Attends -negotiations wneuevw outside parties are represented by counsel In negotiations; • Serves as lead attorney for the Agency in administrative proceed- ings originating In the Region; and • Refers requests for emergency temporary restraining orders to the Department of Justice and the appropriate united States Attorney.* Headquarters Program Of f Ice—PTSCMS • Manages national program matters; * Consultation with other offices is required. FIFRA Gompllance/&iforcement 2-2 ^.-t^^^ Manual 1983 ------- Chapter Two General Operating Procedures • Establishes national enforcement compliance priorities; • Provides overall direction to and accountability measures for the enforcement compliance program; • Provides technical support (including support for litigation activities); • Takes lead role in preparing guidance and policy decisions on enforcement compliance Issues; • Consults with the Regions, on enforcement actions at the earliest possible stage in the case development process for the following actions: - "Non-routine" cases of first Impression or those of national significance, - Misuse actions, - Proposed civil penalty settlements involving a monetary reduc- tion of greater than 40 percent, - Injunctions, - Seizures, - Recall requests, and - Requests to override State enforcement actions; and • Works with OLEC in preparing joint guidance for areas in which com- pliance and legal Issues overlap. Registration Division • Determines status of product as a pesticide or device under FIFRA; • Determines registration status of a pesticide; • Assesses significance of scientific test results; • Provides expert witnesses, as appropriate, at legal proceedings; and • Assists In legal services by: - Providing copies of accepted product labels for Regional Office use, - Providing Registration Division support for substantive label defect review, and - Interpreting label defects. FlfRA OaapllaBce/Boforcfflment 2-3 ------- Chapter Two General Operating Procedures OLEC • Provides legal advice regarding enforcement matters to the Assis- tant Administrator of Pesticides and Toxic Substances; • Develops legal and enforcement policies and guidance; • Confers with the Department of Justice on the potential impact of enforcement policy on litigation matters; • Cooperates with the Assistant-Administrator of Pesticides and Toxic Substances in the development of enforcement policies involving both enforcement compliance and enforcement legal activities; and • Assists and supports the Regional Counsel lead attorneys and Department of Justice attorneys by coordinating legal activity and contributing case information to the development process. Office of General Counsel • Provides legal Interpretation of applicable statutes and regula- tions to support the FIFRA enforcement programs; e Has lead responsibility, in consultation with OLEC, for defensive litigation arising out of enforcement actions (e.g., Federal court challenges to EPA'a civil penalty proceedings); and « Represents the Agency in national suspension and cancellation pro- ceedings. -Jtafogcammnt JawMtigalrinii flenter (HEIC) HEIC is located in Denver, Colorado, and functions as a national technical resource and investigative unit. HEIC'a expertise in investigation and evidence discovery can assist case development and provide litigation sup- port. The OLEC establishes HEIC's priorities and its availability. Regional Administrators and the Assistant Administrator for- Pesticides and Toxic Substances are requested to involve HEIC in cases that have preceden- icmnce, <•»..«•»•i»irfi:».<••'•Hf «*i»ai,in. nature. UDmpxiance/flftxorcemenc 2—4 Guidance ------- Chapter Two General Operating Procedures Concurrence Procedures Generally, Headquarters has waived concurrences in routine civil cases. (Criminal cases oust be referred to the Criminal Enforcement Division; see Chapter Nine.) However, consultation is required in the following instances: • Requests to override State enforcement actions; • Requests for all misuse actions; • Requests for reduction of civil penalties greater than 40 percent; and • Requests for recalls, seizures, and Injunctions. The consultation procedures relating to each of the above actions are dis- cussed in the section of the manual pertaining to the individual subject matter. State and Federal Interagency Cooperation FTFRA charges EPA with the responsibility of protecting public health and the environment from the risks associated with exposure to pesticides. In order to fulfill this responsibility, EPA seeks cooperation with appro- priate State and Federal agencies. State Cooperation Cooperative Enforcement Agreements. FIFRA Section 23, authorizes EPA to enter into cooperative enforcement agreements with the States (including Indian tribes). Under these agreements, each State conducts compliance monitoring and enforcement activities under State and Federal pesticide control laws. These activities Include pesticide producer establishment Inspections; marketplace surveillance; pesticide use observations; pesti- cide misuse investigations; experimental use permit Inspections; and certi- fied applicator and restricted use pesticide dealer record inspections. • Compliance Monitoring Activities. Older the cooperative .enforce- ment agreements, State personnel are responsible for conducting in- spections under both FIFRA and the State's pesticide lavs. Daring all Inspections and sample collections performed under FIFRA, the State Inspectors use the standard Federal forms and procedures out- lined in the EPA Pesticides Inspection Manual. However, during all Inspections and sample collections performed under authority of State law, State personnel must use State forms and follow State procedures, including those related to chain of custody. FJLTJIA 6Mpliance/&iforcementIFF" ^^^^ MMM! iiftjf ------- Chapter Two General Operating Procedures • Enforcement Activities. Under the cooperative enforcement agree- ments, the State reviews the quality and sufficiency of evidence gathered in the course of all investigative activities. If evi- dence reveals a violation of only the State's pesticide laws, the State would pursue the appropriate remedy provided by State law. Where evidence reveals a possible violation of only Federal law, the State would forward the information to the EPA Regional Office and prepare testimony and witnesses as necessary. If evidence reveals a violation of both State and Federal law, the State may bring appropriate enforcement action under State law or refer the case to EPA for action under FIFRA. In the event that a case is referred to EPA for action, the Agency case preparation officer should review the case file to ensure that the State inspection procedures adhere to basic constitutional guarantees. If the State evidence gathered by State inspectors is obtained legally and is within the scope of admissible evidence, EPA should proceed with the case. Primacy. FIFRA Section 26 provides that a State shall have primary enforcement rmsponsibility for -pesticide use violations (primacy) if EPA determines that the State has adopted adequate pesticide use laws and has adequate procedures for implementing these laws. In addition, Section 26 allows a State to obtain primacy if the State has entered into a coopera- tive enforcement agreement with EPA or has an approved Section 4 certifica- tion plan that meets the requirements for adequate laws and procedures. Under the Final Interpretive Rule governing FIFRA Sections 26 and 27 (40 C.F.R. Part 173), EPA and each State will annually define significant cases to be tracked by EPA after referral to the State. e Compliance Monitoring Activities. After EPA formally refers a -'case to a State, the Agency mill contact the State to 1-earn the results of the inspection and the State *s proposed enforcement response to the violation. The Region should determine whether the State has conducted an adequate investigation. An investigation should be considered adequate If the State has (1) followed proper sampling and other evidence gathering techniques; (2) responded expedltiouely to the referral; and (3) documented all inculpatory or exculpatory events or Information. If the Region cannot negotiate an adequate Inspection *l£h±he State, tite Region Its «sa JjjumsMgaf 1iw mfter :«otlce rto *fae State, that notice should summarize the facts relating to the State Investiga- tion, discuss the reasons for EPA's determination that the action is inadequate, and state that the EPA mill Initiate its own inves- tigation. • Enforcement Activities. Under primacy, * State has 30 days . w . The teglon-may extend this period if required by the procedural characteristics of the State's regulatory structure. Compliance/Enforcement 2-6 Cnldf"^ manual 1983 ------- Chapter Two _ General Operating Procedures If, after consultation with the State, the Region determines that the State's Intended enforcement response to the violation is inappropriate, EPA may bring Its own action after notice to the State (see 40 C.F.R. Part 173, Section 5 B for criteria). That notice should summarize the facts relating to the State's enforce- ment response, discuss the reasons for EPA's determination that the enforcement action is inadequate, and state that EPA will initiate its own enforcement action. However, regional attorneys should not initiate an enforcement action sooner than 30 days after the matter was referred to the State. If a State determines that the most appropriate enforcement action is not available under State lav, it may refer the case In writing to EPA for enforcement under FIFRA. Federal Interagency Cooperation United States Department of Justice (DOJ). EPA's working relationship with the Department of Justice and the United States Attorneys Office continues to be governed by the June 1977 Memorandum of Understanding between the DOJ and EPA. All criminal cases, collection and seizure actions, and warrants for Inspections under FIFRA must be filed by the DOJ and United States Attorneys Office. EPA Headquarters and regional components are expected to use their best efforts to Insure that a constructive working relationship is maintained with DOJ and to provide assistance to DOJ In the preparation of those actions. (For the procedures for referring actions Involving criminal cases, collection, seizure, or warrants, see the Individual topics in the manual.) Food and Drug Administration (FDA). FDA grants tolerances or exemptions on pesticide products that are proposed to be used in a manner that is likely to result In residues in or. on food or feed. FDA surveillance programs include the collection and examination of samples and data audits. Upon encountering foodstuffs containing pesticide residues .that may have resul- ted from pesticide misuse, the FDA will notify the appropriate EPA Regional Office. EPA will then proceed with its own Investigation. Compliance/finzorcement /-/ Guidance flsimsl 1983 ------- Chapter Two General Operating Procedun 2-8 o«< <<«-*<>T funrnii1 1983 ------- Chapter Two Organ"1 ynt"l o*v1 C?t">T"t8 OOP v inrr _L orria or •MM Mill UK (Mil orria or MX • MMMMTAfln •iMBU •K.mtM «Fr« OF IMI&ATIOI orrtot OF OKI ION airiTics CMfl WIICT MIlfTWI rai orria or orria or IOOMO. «H OTIOI orria or «aMmtra»Ti<>i eMCUWTI orria or •wmtnuiioi IIWU MM. H.C. •SI1IWI «• wrui •»HI or HIO tWODCNT MD WIT1 orriet or •tBIMBBM •two «ma or mimim MICT IMIITWT »iq» rai n.io mm MB orria or •LIOMfTI owta or i «IltT«M H fOI AM. VIK MB ' • MBMTMM arria or *« OM.ITT orrta or IUTWI NBM rai itriciOEi «IB i inricnn MB n»tc maim «urr arna or n»te •OTTMCK orria or m in wmn MUCDIIW orria or CMr«a>- -bewi* mazncs wo FIFBA GoHpllance/Eafore 2-9 1983 ------- Chapter Two Organisational Charts AHKUTE OMMflMTI* f» IMN. M vrtet 9 sum rat fUTICIKS MB TOXIC I MVIIIW ASSOCIATE 8DCML i AM, MMSC A» KAOIATION ' MVISIOT wm. atw win rat 4MMM*HMTI«M OIVIIIOH CUTE «»IL LITtttTIW. AM OIIIIIMN. eraMoerr MVUION HLICT torr IMIESTIMTION CENTER KNVEH ;MTE CIVIL . Ksriciocs/raucs UTE CIVIL MTC CIVIL LITMATIOH, MSR •RMIM MCBIOMU. • TONK MT 90HOB. Ill PNIUOCLMIA M •BICWV. ATUMTA « . VI n VII VIII CO u CA WBIOML coM«a x KAT7LE m FPBA 2-10 1983 ------- Chapter Two Organizational Charts OFF ICC OF PCSTICIKS AND TOXIC SUBSTANCES OFFICE OF THE ASSISTANT AMINISTUATOft OFFICE or PESTICIDES ADO TOXIC SUBSTANCES ASSISTANT ADMINISTRATOR SCIENCE AMD POLICY ANALYSIS STAFF EXECUTIVE 01HECTOR SPECIAL ASSISTANT NEAULATORT REFORM STAFF COMPLIANCE MOM I TOM IMS STAFF -L ADMINISTRATION BU06ET AND FEDERAL REGISTER STAFF CHEMICAL COORDINATION STAFF DIRECTOR'S OFFICE POLICY AND 0RANTS UNIT FIFRA Co«pllance/Enf ore 2-11 ial 1983. ------- Chapter Two Organizational Charts OFFICE OF PESTICIDE PROGRAMS OFFICE OF THE DIRECTOR Office Director Deputy Office Director PROGRAM MANAGEMENT ft SUPPORT DIVISION ADMINISTRATION WANCH RESOURCE NGMT. ft EVALUATION BRANCH INFORMATION SERVICES BRANCH ; "SYSTEMS -BRANCH BENEFITS ft USE DIVISION IBM ft PROGRAM COORDINATION STAFF NATIONAL LAB. AUDIT PROGRAM STAFF CHEMICAL OPERATIONS BRANCH SCIENCE SUPPORT BRANCH ECONOMIC ANALYSIS BRANCH POLICY ft SPECIAL PROJECTS STAFF HAZARD EVALUATION DIVISION TOXICOLOGY BRANCH EJPOSURE ASSESSMENT BRANCH ECOLOGICAL EFFECTS BRANCH RESIDUE CHEMISTRY L BRANCH SCIENCE INTEGRATION STAFF MANAGEMENT SUPPORT STAFF ADMINISTRATIVE STAFF REGISTRATION DIVISION Director Deputy Director PROGRAM COORDINATION STAFF TEAM 1 1C1DL- D£ BRANCH IAMAGEMENT *12 lANAGEMENT *15 lANAGEMENT 1 #16 lANAGEMENT 1 «17 mm mm mm '•' Iff Hi 1 :M£itBJCIDE FUNGICIDE BRANCH . PRODUCT MANAGEMENT TEAM 121 PRODUCT MANAGEMENT TEAM §23 PRODUCT MANAGEMENT TEAM #25 TECHNICAL SUPPORT SECTION y-i ... •• mm mm mU 1 DISINFECTANT ' : •'•«RMC« PRODUCT MAMAGFMFUT TEAM 131 PRODUCT MANAGEMENT ..TEAMJJ2 TECHNICAL SUPPORT SECTION ------- Chapter Two Organizational Charts REGION I REPORTS TO HQ OFFICE OF LEGAL AND ENFORCEMENT COUNSEL REGIONAL ADMINISTRATOR DEPUTY REGIONAL ADMINISTRATOR OFFICE OF INTERGOVERNMENTAL LIAISON •«advisory to) OFFICE OF PUBLIC AFFAIRS ADMINISTRATIVE SERVICES DIVISION AIR MANAGEMENT DIVISION HASTE MANAGEMENT DIVISION HATER MANAGEMENT DIVISION DEPUTY DIRECTOR ENVIRONMENTAL SERVICES DIVISION EEO OFFICER PERSONNEL BRANCH PLANNING AND EVALUATION BRANCH OFFICE OF PESTICIDES AND TOXIC SUBSTANCES STATE AIR PROGRAMS BRANCH STATE HASTE PROGRAMS BRANCH HASTE RESPONSE AND COMPLIANCE BRANCH TECHNICAL SUPPORT BRANCH - GRANTS ADM. AND FINANCE BRANCH OFFICE OF 4 PROGRAM SUPPORT MUNICIPAL FACILITIES BRANCH TECHNICAL SUPPORT BRANCH SURVEILLANCE BRANCH HATER SUPPLY BRANCH HATER QUALITY BRANCH JFJLFKA coapxiance/enxorc 2-1J ------- Chapter Two Organisational Charts REGION II REPORTS TO HQ OFFICE OF LEGAL Mffi ENFORCEMENT COUMSB. REGIONAL ADMINISTRATOR DEPUTY REGIONAL ADMINISTRATOR ASSISTANT REGIONAL ADMINISTRATOR FOR POLICY AND DEPUTY DIRECTOR EEO OFFICER PERSONNEL « ORGANIZATION •RANCH {•FORMATION SYSTEMS ENVIRONMENTAL IMPACTS •RANCH POLICY < PROGRAM INTEGRATION BRANCH FINANCIAL MANAGEMENT BRANCH FACILITIES « ADMINISTRATIVE MANAGEMENT BRANCH MMTNISTRATION , ttANCH PERMITS ADMINISTRATION . BRANCH PLANNING « EVALUATION AIR AND WASTE MANAGEMENT DIVISION Mffltn OUtECTOR AIR PROGRAMS BRANCH to) r— — REGIONAL COUNSEL CONGRESSIONAL AND INTERGOVERNMENTAL LIAISON MATER MANAGEMENT DIVISION • \------- Chapter Two Organ! imt*1 o*Mfi REGION III REGIONAL ADMINISTRATOR DEPUTY REGIONAL ADMINISTRATOR ASSISTANT REGIONAL ADMINISTRATOR FOR POLICY AND MANAGEMENT EEO OFFICER MANAGEMENT ADMINISTRATION BRANCH COMPTROLLER PERSONNEL MANAGEMENT BRANCH STATE PROGRAMS BRANCH ENVIRONMENTAL IMPACT BRANCH REPORTS TO HQ OFFICE OF LEGAL AND ENFORCEMENT COUNSEL -«(advisory to) OFFICE OF CONGRESSIONAL AND INTERGOVERNMENTAL LIAISON OFFICE OF PUBLIC AFFAIRS AIR AND WASTE MANAGEMENT DIVISION DEPUTY DIRECTOR AIR PROGRAMS AND ENERGY BRANCH AIR AND HASTE COMPLIANCE HASTE MANAGEMENT BRANCH HATER PROGRAM DIVISION DEPUTY DIRECTOR ENVIRONMENTAL SERVICES DIVISION DEPUTY DIRECTOR HATER PROGRAM MANAGEMENT A SUPPORT BRANCH MD/DE/VA/DC BRANCH PA/HY BRANCH HATER SUPPLY MATER PERMITS BRANCH WESTERN REGIONAL LABORATORY AND ENVIRONMENTAL CENTER WHEELING, HV CENTRAL REGIONAL LABORATORY ANNAPOLIS, ND ENVIRONMENTAL EMERGENCY BRANCH AIR QUALITY MONITORING BRANCH HATER QUALITY MONITORING STAFF TlfEA. Coapliance/Baxor 2-15 1983 ------- Chapter Two Organizational Charts REGION IV REPORTS TO HQ OFFICE OF LEGAL AND ENFORCEMENT COUNSEL REGIONAL ADMINISTRATOR DtPUTT RESIDUAL ADMINISTRATOR ASSISTANT REGIONAL ADMINISTRATOR FOR POLICY AND MANAGEMENT EEO OFFICER OTIRQNNENTAL ASSESSMENT BRANCH MANAGEMENT BRANCH PERSONNEL AND , ORGANIZATION BRANCH POLICY AND PROGRAM EVALUATION BRANCH BUDGET OFFICE HATER MANAGEMENT DIVISION . DEPUTY DIRECTOR FACILITIES PERFORMANCE BRANCH MATER SUPPLY BRANCH ^advisory to) REGIONAL COUNSEL OFFICE OF CONGRESSIONAL AND EXTERNAL AFFAIRS AIR AND WASTE MANAGEMENT DIVISION . DEPUTY DIRECTOR EMERGENCY AND REMEDIAL RESPONSE BRANCH RESIDUALS MAMA6EMEKT BRANCH PESTICIDES AND TOXICS BRANCH ENVIRONMENTAL SERVICES DIVISION DEPUTY DIRECTOR ANALYTICAL SUPPORT •RANCH •ECOLOGICAL SUPPORT ENGINEERING SUPPORT BRANCH ^Uft MANAGEMENT iCRMCH FHBA 2-16 Orldi 1963 ------- Chapter Two Organizational Charts REGION V REPORTS TO HQ OFFICE OF LEGAL AND ENFORCEMENT COUNSEL REGIONAL ADMINISTRATOR DEPUTY REGIONAL ADMINISTRATOR OFFICE OF PUBLIC AFFAIRS GREAT LAKES NATIONAL PROGRAM •^(advisory to) REGIONAL COUNSEL OFFICE OF CONGRESSIONAL AND INTERGOVERNMENTAL LIAISON PLANNING AND MANAGEMENT DIVISION ENVIRONMENTAL REVIEW BRANCH EQUAL EMPLOYMENT OFFICER — FINANCIAL MANAGEMENT BRANCH PERSONNEL BRANCH MANAGEMENT SERVICES BRANCH PLANNING AND ANALYSIS BRANCH AIR MANAGEMENT DIVISION OFFICE OF RADIATION PROGRAMS AIR COMPLIANCE BRANCH AIR PROGRAMS BRANCH HASTE MANAGEMENT DIVISION DEPUTY DIRECTOR WASTE MANAGEMENT BRANCH REMEDIAL RESPONSE BRANCH TOXIC SUBSTANCES BRANCH r HATER MANAGEMENT DIVISION IEPUTY DIRECTOR WATER QUALITY BRANCH MUNICIPAL FACILITIES BRANCH DRINKING HATER /GROUNDUATER PROTECTION BRANCH [ ENVIRONMENTAL SERVICES DIVISION IEPUTY DIRECTOR QUALITY ASSURANCE OFFICE ENVIRONMENTAL MONITORING . BRANCH CENTRAL REGIONAL LABORATORY CENTRAL DISTRICT OFFICE EASTERN DISTRICT OFFICE. OHIO MICHIGAN FIELD INVESTIGATIONS SECTION OFFICE OF INSPECTOR GENERAL NORTHERN DIVISION DEPUTY DIRECTOR •751 lii ore 2-17 1983 ------- Chapter Two Organizational Charts REGION VI REPORTS TO HO OFFICE OF LEGAL AND ENFORCEMENT COUNSEL REGIONAL ADMINISTRATOR DEPUTY REGIONAL ADMINISTRATOR ASSISTANT REGIONAL ADMINISTRATOR FOR MANAGEMENT DEPUTY 'DIRECTOR EEO OFFICER PERSONNEL SERVICES BRANCH • SAFETY OFFICER REGIONAL 4J COMPTROLLER RESOURCES MANAGEMENT BRANCH GRANTS ADMINISTRATION BRANCH MANAGEMENT SERVICES BRANCH AIR AND HASTE MANAGEMENT DIVISION DEPUTY DIRECTOR AIR BRANCH HAZARDOUS 4 MATERIALS BRANCH ((advisory to) OFFICE OF CONGRESSIONAL AND INTERGOVERNMENTAL LIAISON OFFICE OF PUBLIC AFFAIRS HATER MANAGEMENT DIVISION DEPUTY DIRECTOR ^PESTICIDES TOXICS BRANCH CONSTRUCTION GRANTS BRANCH ENFORCEMENT BRANCH •MMCH MATER QUALITY MANAGEMENT BRANCH JDPPLT BRANCH /-. • •) ENVIRONMENTAL SERVICES DIVISION DEPUTY DIRECTOR EMERGENCY RESPONSE BRANCH FEDERAL ACTIVITIES BRANCH 3NRVEUJJUCE •WNCH HOUSTON •RANCH :.«M - "ABMW ~---'MMIGN OFFICE OF QUALITY ASSURANCE Oomp 1aanrr/Bnro 2-18 ftrldmce Manual 1983 ------- Chapter Two Organizational Charts REGION VII REPORTS TO HQ OFFICE OF LEGAL AND ENFORCEMENT COUNSEL REGIONAL ADMINISTRATOR DEPUTY REGIONAL ADMINISTRATOR ASSISTANT REGIONAL ADMINISTRATOR FOR POLICY AND MANAGEMENT REGIONAL COMPTROLLER BRANCH ADMINISTRATIVE SERVICES BRANCH PERSONNEL AND ORGANIZATION BRANCH ENVIRONMENTAL REVIEW BRANCH JL AIR AND WASTE MANAGEMENT DIVISION DEPUTY DIRECTOR •<( advisory to) CONGRESSIONAL AND INTERGOVERNMENTAL RELATIONS OFFICE OF PUBLIC AFFAIRS WATER MANAGEMENT DIVISION DEPUTY DIRECTOR AIR AND WASTE COMPLIANCE BRANCH HASTE MANAGEMENT BRANCH AIR BRANCH ENVIRONMENTAL SERVICES DIVISION CONSTRUCTION GRANTS BRANCH DRINKING WATER BRANCH HATER COMPLIANCE BRANCH RAD 4 COORDINATION QA OFFICER LABORATORY BRANCH FIELD INVESTIGATION BRANCH EMERGENCY PLANNING 4 RESPONSE BRANCH 2-19 Cold* 1983 ------- Chapter Two Organisational Charts REGION nil REPORTS TO HQ OFFICE OF LEGAL AND ENFORCEMENT COUNSEL REGIONAL ADMINISTRATOR DEPUTY REGIONAL ADMINISTRATOR •<(advisory to) REGIONAL COUNSEL ASSISTANT REGIONAL ADMINISTRATOR FOR POLICY AND MANAGEMENT _L EEO OFFICER ADMINISTRATIVE SERVICES BRANCH GRANTS ft FINANCIAL MANAGEMENT BRANCH MANAGEMENT SYSTEMS AND ANALYSIS PERSONNEL AND ORGANIZATION BRANCH COMPUTER SYSTEMS HUNCH ENVIRONMENTAL ASSESSMENT BRANCH RESOURCE PLANNING AND MANAGEMENT AIR AND WASTE MANAGEMENT DIVISION AIR PROGRAMS BRANCH TOXIC SUBSTANCES BRANCH . I«ST£ - M*BAGEMOT BRANCH OFFICE OF RADIATION . PROGRAMS CONGRESSIONAL AND INTERGOVERNMENTAL RELATIONS MONTANA OPERATIONS OFFICE OFFICE OF PUBLIC AFFAIRS :• MATER MANAGEMENT DIVISION COMPLIANCE BRANCH MUNICIPAL FACILITIES BRANCH 'PROGRAMS BRANCH DRINKING HATER BRANCH -v ENVIRONMENTAL SERVICES DIVISION FIELD OPERATIONS BRANCH ANALYTICAL SUPPORT BRANCH (LABORATORY) RESPONSE BRANCH DATA ANALYSIS •RANCH 2-20 Cnldi Manual 19B3 ------- Chapter Two Organizational Charts REGION IX REPORTS TO HQ OFFICE OF LEGAL AND ENFORCEMENT COUNSEL RESIONAL ADMINISTRATOR DEPUTY REfilONAL ADMINISTRATOR OFFICE OF POLICY AND RESOURCES MANAGEMENT COMPTROLLER MANAGEMENT SYSTEMS 4 EVALUATION BRANCH •<(idv1sory to) REGIONAL COUNSEL OFFICE OF CONGRESSIONAL AND INTERGOVERNMENTAL LIAISON OFFICE OF PUBLIC AFFAIRS ADMINISTRATIVE SERVICES DIVISION i. EEO OFFICER HEALTH AND SAFETY OFFICER FOI COORDINATOR PERSONNEL AND ORGANIZATION BRANCH GRANTS AND PERMITS , ADMINISTRATION BRANCH SUPPORT SERVICES BRANCH AIR MANAGEMENT DIVISION DEPUTY DIRECTOR AIR OPERATIONS BRANCH AIR PROGRAMS BRANCH TOXICS AND HASTE MANAGEMENT DIVISION DEPUTY DIRECTOR PROGRAMS BRANCH COMPLIANCE AND . RESPONSE BRANCH HATER MANAGEMENT DIVISION DEPUTY DIRECTOR OFFICE OF TERRITORIAL PROGRAMS PROGRAM SUPPORT BRANCH CALIFORNIA BRANCH ARIZONA, NEVADA AND HAWAII BRANCH TECHNICAL SUPPORT •RANCH 2-21 1983 ------- Chapter Two Organizational Charts REGION X REPORTS TO HQ OFFICE OF LEGAL AND ENFORCEMENT COUNSEL REGIONAL ADMINISTRATOR DEPUTY REGIONAL ADMINISTRATOR ALASKA OFFICE OREGON OFFICE IDAHO .OFFICE WASHINGTON OFFICE <« advisory to) REGIONAL COUNSEL CONGRESSIONAL AND INTERGOVERNMENTAL RELATIONS OFFICE OF WBLIC AFFAIRS MANAGEMENT DIVISION EEO OFFICER 'TWWCE OFFICER PERSONNEL ., j aBMJNISTRATm -' - , .- . ^SERVICES . . BRANCH •-GRANTS AND ADMINISTRATION BRANCH AIR AND HASTE MANAGEMENT ; -DIVISION AIR BRANCH SUPERFUND BRANCH RCRA BRANCH E • 'I 1 OUHATIOI WMNCM MATER DIVISION COMPLIANCE BRANCH ENVIRONMENTAL SERVICES DIVISION CONSTRUCTION GRANTS BRANCH MATER QUALITY BRANCH WTEt BRANCH TECHNICAL SUPPORT BRANCH FIELD OPERATIONS BRANCH (LABORATORY) EMERGENCY RESPONSE PTVPA 2-22 19SS ------- Chapter Three Compliance Monitoring Procedures Chapter Contents Page 1 Introduction 3-1 « 2 Inspections 3-3 Custodial Situations 3-3 Noncustodial Situations 3-4 2a Records and Establishment Inspections 3-5 Authority 3-5 Scope 3-5 Purpose 3-6 Elements of an Inspection 3-6 2b Use/Misuse Investigations 3-9 General 3-9 Authority 3-9 2c Warrants 3-13 Authority 3-13 Policy 3-13 Securing and Serving a Warrant 3-15 Exhibit 3-1: Model Affidavit in Support of Application for a Warrant 3-18 Exhibit 3-2: Model Warrant 3-21 3 Subpoenas 3-23 FTFBA tfarr\1*tn**/*afarefmt>nr 3^1 C^Ufnf* "fTTIHl |««* ------- Chapter Three Contents Ompllmce/Enf ------- Chapter Three 1 Introduction Compliance monitoring is a term used to describe the wans by which EPA verifies conformance with statutory and regulatory requirements. In the context of FIFRA, this includes the following types of activities: • Books and Records Inspections; • Establishment Inspections; and • Use/Misuse Investigations. In the event that an owner or operator of a regulated facility denies an inspector entry to perform any of the above inspections, FIFRA authorizes officers or employees of EPA who have been duly designated by the Adminis- trator to obtain and execute entry and inspection warrants. This chapter briefly outlines the procedures associated with these FIFRA compliance monitoring activities. FIFRA flfrMfl 1 w°*f ™f«*^r**»fiit' 3—1 Oi^y1*** Msnrnl 1983 ------- Chapter Three Introduction 1583 ------- Chapter Three 2 Inspections Compliance inspections are the primary enforcement mechanisms used to detect and verify violations. Facilities are selected for inspection either under a neutral administrative inspection scheme or "for cause." (See definition of an unprogrammed inspection in the Glossary.) Selection may be made, depending on the circumstances, by Headquarters or Regional Offices in cooperation with States with EPA enforcement grants. Evidence obtained during an inspection may result in the Agency taking any of the following enforcement actions: • Issuance of a notice of warning; • Request for voluntary recall; • Issuance of a stop sale, use, or removal order (SSURO); • Assessment of an administrative civil penalty; • Institution of a civil court action; and • Institution of a criminal court action. Custodial Situations Compliance inspections conducted by EPA personnel under the authority of FIFEA generally will not involve the need to warn Individuals of their rights under the fifth amendment of the United States Constitution. The fifth amendment provides that "Ho person...shall be compelled in any criminal case to be a witness against himself." Issues concerning this right arise whenever a person is taken into custody or otherwise has his or her freedom restricted by law enforcement officers. Since inspections under FIFRA are generally not conducted by law enforcement officers and do not involve custodial situations, fifth amendment rights are not implicated. FIFRA Compliance/Enforcement 3-3 A^^m^-m Manual 1983 ------- Chapter Three Inspections All individuals who conduct such Inspections should be aware of what constitutes a custodial situation. When an individual is under arrest, he or she is clearly in custody. However, a custodial situation may also be created when, as a result of the demeanor and authority of the questioner and the physical situation, a reasonable person would not feel free to leave. These types of situations should be avoided during an administrative inspection. Noncustodial Situations Stateaents made to an inspector during a noncustodial administrative inspection should be given voluntarily. The term voluntary, as used in the judicial sense, relates to the circumstances surrounding the investigation and the taking of statements. Such diverse factors as the following are considered: • Coercion or threats by the interviewer; • Overbearing will of the interviewer; • Promises of benefit by persons in authority; • Deceit by the interviewer during the interrogation; • The accused's age, experience, and level of education; and • The accused's knowledge of his or her constitutional rights. FIFBA ™^|««*jMM»»/|fnf"nrr(mnt 3-4 gnf^y««-» n^*™-"! 1983 ------- Chapter Three 2a Records and Establishment Inspections Authority Sections 8(b) and 9(a) of FIFRA authorize any officer or employee of EPA or any State or political subdivision duly designated by the Administrator to enter facilities under the scope of the Act in order to Inspect and to copy records, as veil as to inspect and to sample pesticides or pesticidal devices that are packaged, labeled, and released for shipment. Inspections must be conducted in a prescribed manner Including the: • Presentation of credentials to owner, operator, or agent in charge; • Presentation of a notice of inspection detailing the suspected violation or cause for the inspection; • Entry at a reasonable time and prompt completion; and • Issuance of a receipt for samples in the case of an establishment or marketplace inspection. Section 12(a)(2)(B) of FIFRA makes it unlawful for any person to refuse to allow an EPA officer or employee to take a sample of any pesticide or to inspect records or establishments covered by Sections 8 or 9. Scope Inspections conducted under Section 9 of FIFRA extend to the inspection of facilities where pesticides or pesticidal devices are held for distribution or sale. Samples may be taken of pesticides and pesticidal devices released for shipment. Samples may also be taken of any container or label for such pesticides or pesticidal devices. FIFBA Qsaplisace/B&xorceaent 3-5 tp,iAm~~» Manual 1983 ------- Chapter Three Records and Establishment Inspections The scope of establishment Inspection does not extend Into manufacturing, formulating, repackaging, or technical material storage areas because FIFRA does not provide explicit authority to enter these areas. The inspector does have access to areas (1) where pesticides or devices are packaged, labeled, and released for shipment; (2) where containers and labeling of pesticides or devices are stored; and (3) where books and records, referred to In Sections 8 and 9 of the Act, are kept. Records Inspections conducted under Section 8(b) of FIFRA extend to the Inspection and copying of .records showing the delivery, movement, or holding of pesticides or pesticldal devices. FIFRA limits the extent of records inspections by providing that no regula- tion or Inspection may extend to records of: • Financial data; • Sales data (other than shipment data); • Pricing data; • Personnel data; and • Research data (other than data relating to registered pesticides or to information on a pesticide for which an application for registration has been made). Purpose .. The purpose of an inspection is to ensure compliance with FIFRA and with the rules promulgated under FIFRA. In summary, the Inspector's role is: • To inform the regulated industry of the requirements of the law; • To document suspected violations. Elements of an Inspection The elements of FIFRA facility inspections can be grouped into the fol- report preparation. These elements are common to all inspections, but the emphasis given to the separate elements will vary with the needs of the Individual Inspection. F.TFKA &nl±*ace/Enxorcement 3—o "r*ii.fnc* tts**"*1 1983 ------- Chapter Three Records and KstabJJ °**wnt Inspections Pre-Inapectlon Preparation To ensure effective use of the inspector's time, the following procedures are undertaken before beginning the inspection of a selected facility: • Establishing inspection objectives; • Establishing the scope of the inspection; • Conducting a review of Agency records; • Preparing necessary documents; and • Preparing sampling equipment and safety equipment. Entry Entry procedures are followed to obtain actual physical entry into the facility. Entry involves the following steps: • Introduction; • Presenting official credentials; • Presenting the notice of inspection; and • Managing denial of entry when necessary (see Section 2c of this chapter). Opening Conference After entry, the inspector conducts an opening conference with the facility management. During the opening conference, the inspector is responsible for the following activities: • Discussing the objectives and scope of the Inspection; • Advising of the availability of duplicate samples; • Providing information on FIFRA and its rules; and • Planning meetings with personnel. 3-7 ------- Chapter Three Records and Eat*bH"*»^»nt Sampling and Documentation Reviewing facility records, taking official samples, and preparing documen- tation are the basic inspection activities. It is these activities that provide the evidentiary support the Agency uses in enforcement actions. The inspector's responsibilities include: • Targeting facility and locating records; • Inspecting facility records; • Preparing documentation of fli/» inspection activities; • Inspecting conditions and taking photographs, if necessary; • Taking necessary samples, sealing samples, and establishing "chain of custody"; and • Operating in a .safe and .efficient manner. Closing Conference The closing conference with facility officials enables the Inspector to prepare receipts, answer questions, and provide information about FIFBA. At the closing conference, the inspector "wraps up" the inspection by: • Writing necessary receipts; • Advising that results of analysis of an official sample will be furnished if and when analysis is made; and • Discussing Inspection findings. Report Preparation All evidence must be organized and coordinated in a comprehensive, rele- vant, and accurate report including; • Narrative report; and • Other documentary support. Suspected violations are to be documented in the above reports. Compliance «f *me-«vide«c*. ------- Chapter Three 2b Use/Misuse Investigations General Investigations to determine whether pesticides are being properly used can be divided into two categories: • Use Inspections. This includes routine investigations or observa- tions made on a cross section of pesticide uses during or Immedi- ately following application. The purpose of use inspections is to develop data on the common practices of applying pesticides, to encourage the proper use of pesticides, and to determine whether pesticides are being used in accordance with their directions. It is Agency policy to obtain the consent of the owner, operator, or person In charge of the premises for this type of investigation. • Misuse Investigations. This Includes investigations of reported or suspected cases of pesticide misuse. These investigations are con- ducted to develop evidence in support of enforcement actions arising from the use of a registered pesticide in a manner Incon- sistent with its labeling. Entry should be on the basis of consent freely given or with a valid search warrant since information gathered to support a subsequent enforcement action must be protec- ted for admission into court as evidence. Use/Misuse investigations will generally proceed through the same stages as the records and establishment inspections described in this chapter. However, for details on the procedures for entering and conducting a use/ misuse Investigation, please refer to the FIFRA Inspection Manual, Chapter 6, "Use/Misuse Investigations*" authority Although Section 12(a)(2)(G) of FIFRA makes It clear that the Agency is to enforce against the misuse of pesticides, FIFRA does not provide expressed Compll ------- Chapter Three Use/Misuse Investigation authority to conduct use/misuse investigations. Nonetheless, the following statutory and common law doctrines are available to the Agency for conduc- ting these investigations. Statutory Basis Where there is "probable cause" that a violation of one of the "use" provisions of the Act has occurred, a warrant [FIFBA S9(b)*] authorizing entry f or the purpose of /inspecting and sampling may be obtained. (See Section 2c of this chapter.) Section 9(a) of FIFRA authorizes entry Into those places where pesticides are held for distribution and sale for the purpose of inspecting and sam- pling pesticides that are (or have been) packaged, labeled, and released for shipment. In the context of pesticide use inspections, Section 9(a) permits entry into establishments of those persons who offer "for hire" applicator services. These types of establishments would include the or applicator service vehicle or any other service equipment used to hold the pesticide for distribution or sale. Common Law Basis If the above statutory authorities do not apply, entry and sampling for purposes of a use/misuse Investigation may occur only when one of the fol- lowing common law doctrines applies: • Consent . Consent must be given freely and voluntarily (not as a :«f dnr«ss,/ml»jepi»sentatlon, cr ^coercion) ty the owner, ills i;ker ^«gent , *or the -person -In •charge -of •the property or "premises . For repeated Inspections at the same site, it Is necessary to obtain consent for each entry and sampling unless prior consent is given to cover all such inspections. Section 9(b) of FIFBA authorizes employees duly designated by the Administrator to obtain Inspection warrants in order to enter a facility for purposes of JLaspectlng jmd.saapllng JJ there Is "probable -cause" to evidence necessary to establish probable cause for an administrative warrant under Section 9(b) of FIFRA is less than that necessary to obtain a criminal search warrant, sufficient evidence must be available to demonstrate that it is reasonable 'to conclude that specific provisions of FIFBA have been violated. FIFBA Gampllmfff*nfvttt!*Bttt 3-10 ------- Chapter Three Use/Misuae Investigation • Exigent Circumstances. If a serious situation exists, such as the endangeroent of human health or public safety occurring on private property, an inspector may enter the property to assist in preven- ting the harm when: - There is Insufficient time to procure a warrant, and - Consent cannot be readily obtained. This doctrine should be used only in rare instances since it places a heavy burden on the Agency to justify its entry without author- ity. • Plain View. This doctrine applies in those Instances where an inspector has lawfully gained entry onto private property or pr« ises (such as to conduct monitoring or to follow up an accident report) and subsequently encounters a violation in his or her "plain view." The inspector may observe and document the violation so long as he or she stays within the scope of the authorization to enter the property or premises. • Open Fields. An Inspector may observe and document a violation occurring in an open area within his or her view so long as the Inspector does not enter the property on which the violation is occurring. For example, an inspector on a country road can observe and prepare evidence on a visible misuse that is occurring in a field adjacent to that road. FUfMA Compliance/Enforcement 3-11 Quid* ------- Chapter Three Pae/Mlsnse Investigation ------- Chapter Three 2c Warrants A warrant can be used to gain entry Into a facility vhen facility officials have denied entry to an inspector or have withdrawn their consent to in- spect during an Inspection. In certain circumstances it may be necessary to obtain a warrant prior to an Inspection. A warrant is a judicial authorization for an appropriate official (EPA inspector, State inspector, U.S. Marshal, or other authorized officer) to enter a specifically des- cribed location and perform clearly defined inspection functions. Authority Section 9(b) of FIFRA authorizes officers or employees duly designated by the Administrator to obtain and execute warrants authorizing: "(1) entry for the purpose of this section; "(2) inspection and reproduction of all records showing the quantity, date of shipment, and the name of consignor and consignee of any pesticide or device found in the establishment which is adulter- ated, mlsbranded, not registered (in the case of a pesticide) or otherwise in violation of this Act and in the event of the inability of any person to produce records containing such infor- mation, all other records and information relating to such delivery, movement, or holding of the pesticide or device; and "(3) the seizure of any pesticide or device which is in violation of this Act." Policy _____ It is the policy of EPA to obtain a warrant when all other efforts to gain lawful entry have been exhausted. This policy, of course, does not apply to pre-inspection warrants. 3-13 ------- Chapter Three ___^^_ Warrants Marshall v. Barlow's Inc. In Marshall v. Barlow's, Inc., 436 U.S. 307 (1978), the Supreme Court addressed the need for an administrative warrant when an Occupational Health and Safety Administration (OSHA) inspector sought entry into a workplace where consent for the inspection was not voluntarily given by the owner. The Court concluded that an administrative warrant was required to conduct such regulatory inspections unless the industry is one with a history of extensive regulation, such as liquor or firearms. EPA guidance ^recognizes that, inspections conducted pursuant to authority under flrnA may constitute an exception to the Barlow's decision, due to the long histroy of Federal regulation of pesticide Manufacture. Although the issue has not been tested, as a Batter of policy, the Agency will apply the requirements of Barlow's to all FIFRA inspections, Including inspections conducted by State personnel. According to Barlow's, a warrant may be obtained where there is a specific reason to think that a violation has been committed (i.e., where there is probable cause auch as an employee's complaint or a competitor's tip). A warrant may also be issued if the Agency can show that the establishment to be Inspected has been selected pursuant to a neutral Inspection scheme. To meet Barlow's requirements and to carry out its duties under the Act, the Agency has developed criteria to be used in selecting an activity for a programmed (neutral) Inspection. (See Appendix 1, Neutral Administrative Inspection Scheme, for details of the criteria.) Seeking a Warrant Before Inspection A warrant may be obtained before the inspector sets forth to conduct the Inspection. - ;m pre-dnspeetion wmrrant maty fre obtained :at the discretion of tbe Kcgltmal Office If: • A violation is suspected and could be covered up within the time needed to secure a warrant; • Prior correspondence or other contact with the facility to be Inspected provides reason to believe that entry will be denied when the Inspector arrives; or • The facility Is unusually remote from a magistrate or a district court, and thus obtaining a warrant would require excessive travel Civil Versus Criminal warrants *of ,£ne ^Ixsipetctlon Is^fiO'^dlxcovex and '^correc procedures, noncompliance with regulatory requirements, a civil warrant should be secured if entry is refused. FTFBA Campllanee/aworoement 3-14 Guidance r*""**1 1983 ------- Chapter Three Warrants If the primary purpose of the inspection is to gather evidence for a criminal prosecution and there is sufficient evidence available to establish probable cause for a criminal warrant, then a civil warrant should not be used to gain entry. Rather, a criminal search warrant must be obtained pursuant to Rule 41 of the Federal Rules of Criminal Procedure (Fed. R. Grim. P.). (See Agency "Guidelines for the Use of Administrative Discovery Devices in the Development of Potential Criminal Cases.") Evidence obtained during a valid civil inspection is generally admissible in criminal proceedings. Securing and Serving an Administrative Warrant The following procedures for obtaining and serving a warrant have been developed in accordance with the Barlow's decision. Important Procedural Considerations • The application for a warrant should be made as soon as possible after the denial of entry or withdrawal of consent. • In order to satisfy the requirements of the Barlow's decision, the affidavit in support of the warrant must Include a description of the reasons why the establishment has been chosen for inspection. The only acceptable reasons are specific probable cause (e.g., an employee's complaint or competitor's tip) or selection of the establishment for 'inspection pursuant to a neutral administrative inspection scheme. • A warrant must be served without undue delay and within the number of days stated (standard is 10 days). The warrant will usually direct that It be served during daylight hours. • Since the inspection is limited by the terms of the warrant, It is very Important to specify to the greatest extent possible the areas Intended for Inspection, records to be Inspected, samples to be taken, etc. A vague, overly broad warrant, probably will not be signed by the magistrate. • If the owner refuses entry to an inspector holding a warrant but not accompanied by a U.S. Marshal, the Inspector should leave the establishment and inform the U.S. Attorney* Procedures for Obtaining a Warrant 1. Contact the Regional Counsel's Office. The inspector should discuss with the Regional Counsel's Office the facts regarding the denial or withdrawal of consent or the circumstances that gave rlrXA. Oampllance/Birorcemcnt 3-15 Atijfmpr* jjpmml ±983 ------- Chapter Three Warrants rise to the need for a pre-inspection warrant. 'A joint determination will then be aade whether or not to seek a warrant. 2. Contact Headquarters Pesticides and Toxic Substances Program Office. The Regional Office should notify Headquarters PTSCMS prior to obtaining a warrant. 3. Contact the United States Attorneys Office. After a decision has been Bade to obtain a warrant, the designated regional official should contact the U.S. Attorney for the district in which the property is located. The Agency should assist the United States Attorneys Office in the preparation of the warrant and necessary affidavits. 4. Apply for the Warrant. The application for a warrant should iden- tify the statutes and regulations under which the Agency is seeking the warrant. The name and location of the site or estab- lishment to be inspected should be clearly identified, and, if possible, the owner and/or operator should be named. The applica- tion can ibe a one- or two-page document if all factual require- ments for seeking the warrant are stated in the affidavit, and the application so states. The application is to be signed by the U.S. Attorney. 5. Prepare the Affidavits. The affidavits in support of the warrant application are crucial documents. Bach affidavit should consist of consecutively numbered paragraphs that describe all of the facts in support of warrant issuance. Each affidavit should be signed by a person with first-hand knowledge of all the facts stated, most likely the Inspector. An affidavit is a sworn state- ment that must be notarized or sworn to before the magistrate. (See Exhibit 3-1.) 6. Prepare the Warrant for Signature. The draft should be ready for the magistrate's signature. Once signed, the warrant is an enforceable document. The warrant should contain a "return of service" or "certificate of service" that will indicate upon whom the warrant was served. This part of the warrant is to be dated and signed by the Inspector after the warrant is served. (See Exhibit 3-2.) 7. Serve the Warrant. The warrant is served on the facility owner or the agent in charge and the inspection will normally commence or continue. Where there is probability Chat entry will still be refused* or where there are threats of violence, the inspector should be accompanied by a U.S. Marshal. In this case, the U.S. Marshal Is principally charged with executing the warrant, and the Inspector should .-abide .by the g«S.v Marsha] 's decisions. 8. Inspecting With the Warrant. The inspection should be conducted strictly in accordance with the warrant. If sampling is authorised, all procedures must be followed carefully, including presentation of receipts for all samples taken. If records or 3-16 flwMmr* •«—••••' 1983 ------- Chapter Three ga other property are authorized to be taken, the Inspector must issue a receipt for the property and maintain an inventory of anything removed from the premises. This inventory will be examined by the magistrate to ensure that the warrant's authority has not been exceeded. 9. Return the Warrant. After the inspection has been completed, the warrant must be returned to the magistrate. Whoever executes the warrant (i.e., the U.S. Marshal or whoever performs the inspec- tion) must sign the return of service form indicating to whom the warrant was served and the date of service. The executed warrant is then returned to the U.S. Attorney who will formally return it to the issuing magistrate or judge. If anything has been physi- cally taken from the premises, such as records or samples, an inventory of such items must be submitted to the court, and the inspector must be present to certify that the inventory is accu- rate and complete. 3-17 Goldance Iff*"1 1983 ------- Chapter Three *»*r»bit 3-1 Model Affidavit In Support of Application for a Barrant UNITED STATES DISTRICT COURT DISTRICT OF Docket No._ Case No. la the natter of: Affidavit in Support of Application for a Warrant State of County of [Name of Affiant) , being duly sworn upon his (her) oath, according to lav, deposes and says: 1. I am a duly authorized (title) of the (division) , United States Environmental Protection Agency, Region _ . I hereby apply for a warrant pursuant to Section 9 of the Federal Insecticide, airl tmtirnl"ir1ri^ all records showing She quantity, date of shipment, and the name of consignor and consignee of any pesticide or device found in the establishment which is adulterated, misbranded, not registered (in the case of a pesticide) or otherwise in violation of this Act and in the event of the inability A Marat* 1- ------- Chapter Three Exhibit 3-1 of any person to produce records containing such infor- mation, all other records and information relating to such delivery, movement, or holding of the pesticide or device; and "(3) the seizure of any pesticide or device which is in vio- lation of this Act." 3. (Name of establishment, person, or place) is a (describe its business) which the undersigned compliance officer of the United States Environmental Protection Agency has reason to believe is in violation of the Federal Insecticide, Fungicide, and Sodenticlde Act, as amended. This belief is based upon the following facts and Information: (Summarize the reasons why a violation is suspected and the specific facts that give use to the probable cause, or the neutral administrative inspection scheme used to select the facility for inspection.) 4. The (inspection, reproduction of records, sampling, or Issuance of the stop sale, use, or removal order) will be carried out with reasonable promptness, and a copy of the results of analyses performed on any samples or material collected will be furnished to the owner or operator of the subject establishmment or property. 5. The compliance officer may be accompanied by one or more other compliance officers of the United States Environmental Protection Agency. 6. The undersigned compliance officer requests Immediate entry to (name of establishment or place) to perform the inspec- tion, reproduction of records, sampling, or [optional, if needed] the issuance of a stop sale, use, or removal order. 7. A return will be made to the court at the completion of the inspection, reproduction of records, sampling, or the issu- ance of a stop sale, use, or removal order. 8. The authority for the issuance of the inspection warrant is Section 9 of the Federal Insecticide, Fungicide, sad Roden- ticide Act, as amended, and Marshall v. Barlow's Inc., 436 U.S. 307 (1978). 3—19 Guidance Msnoal J.J93 ------- Chapter Three Exhibit 3-1 (Signature of Affiant) (Title) (Division) legion ( ) United States Environmental Protection Agency Before ne, a notary public of the State of . County of , on this _______ day of , 19 , personally appeared , and upon oath stated that the facts set forth in this application are true to his (her) knowledge and .belief. (Signature of Notary) A Notary Public of My Commission Expires FIFBA CoBpliance/Bnforcewent 3-20 f^^tinc^ Mr*-**1 1983 ------- Chapter Three Exhibit 3-2 Model Barrant UNITED STATES DISTRICT COURT DISTRICT OF In the matter of: Docket Mo. Case No. To (name) Warrant for Inspection, Reproduction of Records, Stapling, and Issuing Stop Sale, Use, or Renoval Order of Pesticides or Devices Pursuant to the Federal Insecticide, Fungicide, and Rodentlclde Act, as amended, (7 U.S.C.$§135, 136) , (title) (division), Environmental Protection Agency, Region __ other duly authorized enforcement officer of said division: and any Application having been made and probable cause shown, by (name of officer) , for Inspection and sampling of packaged, labeled, released pesticides or devices, as veil as labeling and containers found In the establishment described below; and for Inspection and reproduction of records showing quantity, date of shipment, and the name of consignor and consignee of any pesticide or device found in said establishment which is adulterated, misbranded, not registered in the case of a pesticide or otherwise in violation of the Federal Insecticide, Fungicide, and Rodentlclde Act, as amended, or should such records not be available for Inspection, **! other available records and information relating to such delivery, movement, or holding of any pesticide or device that is in violation of the said Act; for the Issuance or surveillance of any stop sale, use, or removal order of any pesticide or device that Is in violation of the said Act; all within the establishment or place described as: (Name of establishment or place) (Address) or Application having been made and probable cause shown, by of officer), for inspection or sampling of pesticides used in vloJ tlon of the said Act, at the place described as: (Name of person or property owner) (Address) FXP1A Oompl /Bnfon 3-21 1983 ------- Chapter Three Exhibit 3-2 Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act, as aaended, by the Federal Environmental Pesticide Control Act of 1972, (hereinafter Federal Insecticide, Fungicide, and Rodenticide Act, as amended), the Federal regulations promulgated thereunder and the deci- sion of the Supreme Court in Marshall v. Barlow's, Inc., 436 U.S. 307 (1978), you are authorized to enter (immediately) the above described premises upon presentation of this warrant and therein to carry out the inspections, sampling, reproduction of records, and/or issuance or surveillance of any stop,sale, use,,or removal order described above. (Signature of Magistrate) (Date) RETURN OF SERVICE I hereby certify that a copy of the within warrant was served by presenting a copy of same to (facility owner or agent) on (date) at (location of establishment or place) (Signature of person making service) (Official title) RETURN Jncmectian «f >tb<-sarslil1«hsMiir'4r«CTl%ed invtirij -warrant-was -completed (date) » ttre of person conflnctiag the inspection) TCFRA. Compliance/Enforcement 3—22 ^Vldw*^ n*™**! 1983 ------- Chapter Three 3 Subpoenas FIFEA does not provide for subpoena authority.* Except under PIFHA Section 6(d) where the Administrative Law Judge has subpoena authority to compel testimony or the production of documenta- tion from any person during a cancellation or change of classification proceeding held under FIFKA Section 6(b). FIFEA Compliance/Bozorcement 3-23 ggf^y"* IJ««MI 1983 ------- Chapter Three V1FEA Compliance/Enforcement3-24 '(^14^* M-T,~«I ------- Chapter Four Documentation of Evidence Chapter Contents Page 1 Introduction 4-1 2 Inspection File Review 4-3 Substantiation of Each Violation 4-3 Controlled Identification of Each Sample 4-3 3 Review of Adequacy of Evidence 4-7 Initial Review of the ID' Jacket 4-7 u> Jacket— rEnf or Case Beviev 4-11 Additional Sources of Documentation ' 4-12 CDapxiance/aaxorcaaent 4-1 Guidance nairrf' 1983 ------- ------- Chapter Four 1 Introduction Upon completion of a Section 9 inspection, pesticide enforcement inspectors are required to organize the documentary evidence gathered during this inspection into a file commonly called the 10 (or Sample) Jacket. The ID Jacket file includes all the forms, reports, and documentary evidence secured by the inspector relating to an official pesticide or pesticidal device ample. Once compiled, the f He Is *ent to a Regional Case Develop- ment Officer (RCDO) who reviews the inspection results for possible enforcement action. uompiiance/laatorceaent 4-1 Guidance •*«""«' 1983 ------- ChaPter Four _ Introducti, PIFEA Gkmpllance/EnforceMnt ^T Guidance Manual 1983 ------- Chapter Four 2 Inspection File Review To ensure the validity and quality of documentary evidence for an adminis- trative or judicial enforcement proceeding, the RCDO must review the evi- dence for objectivity, adequacy, and proper identification. In some Instances the RCDO will need an enforcement case review, which could . include the verification of the sample's pesticide registration and labeling status,•• as yell as an interpretation of laboratory -test results. In all cases, the RCDO must verify that all procedural safeguards were implemented so as not to prejudice a possible enforcement action. Substantiation of Each Violation In most cases, a violation will be substantiated through a combination of evidential sources. The RCDO's review must seek to substantiate each possible violation from the evidence supplied by the Inspector. Whenever aecessxry, the, RCDO should obtain from the inspector additional evidence or clmrlf icatitm of existing "evidence. Controlled Identification of Each Sample _ An Important aspect of any review by the RCDO is the determination that all y Whenever a sample is taken, the inspector prepares a Collection Report (EPA Form 3540-7), which describes the sample collection process. Information required for the report Includes: • Type of sample; «• ^Snple amaber, ,«ub«mple mmber; • Date of collection; • Collection method; FIFSA Compliance/Baxorceaent 4-3 Guidance Manual 1983 ------- Chapter Four ________^_ Inspection File Review • Description of sample (including quantity collected, color, tex- ture, viscosity, etc.); • Duplicate samples (if provided); and • Description of procedures for sealing sample. Each ID Jacket will also be identified by a sample number. The RCDO should check the number to see if it corresponds to the ID number on the Collec- tion Report Form. All samples that are to be used as evidence should be sealed with the offi- cial EPA seal (EPA Form 7500-2). The seal is placed on the sample con- tainer by the inspector to help preserve the integrity of the sample. A written receipt (EPA Form 3540-3) describing the sample obtained by the inspector is Issued to the appropriate facility representative whenever a sample is taken. The receipt may also be used to verify that a dupllcatlve sample was given the facility. The ID Jacket may not always include a copy of the receipt. If an enforcement action is considered, a copy may be obtained from the Inspection Report that was filed with the Regional Office. The two types of samples commonly collected are official and investiga- tlonal. Official Samples. These include samples or documents of pesticides or devices that, If violative, serve as a basis for legal action. In general, an RCDO should ensure that an official sample: • Was collected only from material that had been "packaged, labeled, and released for shipment" (see Glossary); • Was representative of the lot from which it was obtained; and • Was Identified and officially sealed so as to maintain Its continu- ity and integrity as court evidence. Official samples include: • Producer/Marketplace Samples. Actual samples of a pesticide or pesticidal device collected by an inspector at the producer, whole- sale, or retail level. • Documentary Samples. Copies of the label and/or labeling and copies of any records showing shipment of the product and the re- sponsible parties. • Post-Seizure Samples. Actual samples collected from a lot of mer- chandise that Is in the custody of a U.S. court. A court order must be entered before sampling, and these actions must be carried out in accordance with such orders. FIFRA Compliance/Enforcement 4-4 Guidance Manual ------- Chapter Four Inspection File Review • Induced Samples. Actual samples of pesticides or pestlcidal devices that are not obtained by EPA official procedures (e.g., notice of inspection, collection report, etc.). These samples are usually requested by mail. An Induced sample is the least desir- able method of obtaining a sample and should be used only when the other methods have been exhausted. • Import Samples. Actual samples of pesticides or pestlcidal devices that are offered for Importation into the United States from a for- eign port. Proper documentation for Import shipments should . Include Customs entry papers, foreign invoices, and records shoving movement from the port of entry. • Use Samples* Actual samples of the pesticide that are collected during a use inspection. This type of sample may be field col- lected from a formulated pesticide, diluted pesticide, or as a res- idue from plant material, animal tissue, soil, water, etc. Investlgatlonal Samples. These include samples of pesticides or devices collected for special Invest! .These samples need not "be collected from lots or stocks that have been packaged, labeled, and released for shipment. No legal action can be taken on investigational samples. FIFKA CoBpllance/Enforceaent 4-5 Guidance yg**"*1 1983 ------- Chapter Four Inspection File Review FIFSA CoBpllance/Eoforceaent 4-6 Guidance Manual 1983 ------- Chapter Four 3 Review of Adequacy of Evidence Initial Review of the ID Jacket Once the RCDO has received the ID Jacket, its contents must be reviewed in context of £he 'following • Adequacy of the documentation (see below); • Significance of violation (see Chapter Five for Level of Action Policy); and • Vlolatlve history of the firm (see Chapter Five for Level of Action Policy). Violative history may be obtained from the FIFRA and TSCA Enforcement System (FATES). of ~ £he DOC^HUPD t B The initial phase of the review will focus on two aspects of the documenta- tion: • That all necessary documentation and samples have been provided; and • That the documentation is adequate to prove the substance of the . fif The purpose of the review is to develop a recommendation for action on the violation; either to proceed with an enforcement action or to dismiss the violation as not worthy of prosecution. In some instances, review will indicate possible violations not documented by the inspection. In these cases, the RCDO should .seek to secure the er consultation with the inspector or forwarding the file to Headquarters for an enforcement case review. When a violation is dis- covered that Is unrelated to the initial suspected violation, that new vio lation should be pursued as a new action. FIFRA Covpllance/Baforceaent 4-7 Guidance Manual 1983 ------- Chapter Four Review of Adequacy of Evidence Contents of the ID Jacket The ID Jacket should normally contain the following items: Label of a Pesticide or Device. The label should either be an actual copy (or photocopy) or a typewritten copy. The label should be Identified by sample number, date of collection, inspector initials, and, if appropriate, subsample numbers. Notice of Inspection (EPA Form 3540-2) or Warrant. If an enforcement action is being considered, a copy of the notice of inspection or warrant may be obtained from the Establishment Inspection Report. The notice and/ or warrant should be reviewed to ensure the inspection adhered to the terms specified in the documents. Receipt for Sample. The written receipt should describe the sample and verify that a duplicate sample, if requested, was given to the facility official. The RCDO should verify sample identification numbers. Collection Report. This is the official report of the sample collection. The following should be verified from the report: • The ID number appearing on the Collection Report should agree with the number on the ID Jacket. For documentary samples, the notation "DOC" will appear after the ID number; for investigational samples, "INV" will appear after the ID number; for post-seizure samples, "P.S." will appear after the ID number; and Import samples will be identified by "Import"; • Date of shipment (from transportation records) of the sample; • Amount of the product before sampling (the amount on hand must be less than or equal to the amount shipped); • Descriptions indicating number of samples and method of collection; • Shipper of sample (from transportation records); and • Reason for collection—either to document a suspected violation, or as part of a "Market Basket Survey" of products without accompany- ing documentation. History of Official Sample (EPA Form 3540-17). This document is placed In the ID Jacket by laboratory personnel once the physical cample has been received by the laboratory for analysis. It shows whether the integrity of the sample has been maintained during its stay at the laboratory. Each time the sample seal is broken and resealed, it mist be noted on the form. It is important for the RCDO to demonstrate that none of the samples Involved in the case preparation have been tampered with or contaminated during collection, transit, storage, or analysis. An accurate accounting FIFBA Co*pliance/Enforce»ent 4-8 Guidance Manual 1983 ------- Chapter Four Review of Adequacy of Evidence must be maintained to trace the possession of each sample from the moment of collection to its introduction as evidence* Accountability can be checked by reviewing the following documents: • Receipt for sample; • Collection report; and • History of official sample. Laboratory Test Methods.. Test .methods employed in the analysis of pesti- cide or pesticidal device samples fall into two categories, official and unofficial. • Official Test Method. Refers to a test method accepted by a recog- nized standard-setting organization, such as the Association of Official Analytical Chemists (AOAC) or the American Society for Testing and Materials (ASTM). • Unofficial Test Method. ^Refers to a method that has not as yet been accepted as a standard method but is employed by EPA in the analysis of a sample because other reliable test methods are not available. Extreme care and Judgment should be exercised In preparing enforcement cases when unofficial test methods are used as the basis for evidence of a violation of the FIFRA. Consultations with Headquarters Case Development Officers (HQCDOs) are strongly recommended before proceeding with enforce- ment actions in these cases. Laboratory Test Results. Test results are placed in the ID Jacket upon o£ the <*naly.siB « " ' Tests .' Include : • Sample Report of Analysis (EPA Form 3540-5), which shows the chemi- cal composition of the sample collected versus composition guaran- teed by the registrant. Usually a cross-contamination will be conducted by the laboratory and the percentage of contaminants, If any, noted; and/or • Efficacy test, which shows the effectiveness jrf the product. ^Evidential 'Documentation. Suspected violations may also be documen- ted by the Inspector using the following support methods: • Affidavit . Sworn statements taken by the Inspector relating to personal first-hand knowledge of a potential violation. The affi- davit may be used to substantiate the violation or to set the cir- the .gff.jfff fCT>T Carttfol TWlCV VDOOU be «f the .affidavit .for 'evidence ±n support of an enforcement action. The person making the affidavit must sign It and be able to personally verify the facts contained in the statement. FIFRA Co*pliance/Enforceaent 4-9 Guidance Manual 1983 ------- Chapter Four Review of Adequacy of Evidence The object of an affidavit Is to obtain a clear and concise written record of factual Information relating to a suspected violation. The oath taken by the person making the affidavit serves to sub- stantiate the truth of the statement. Affidavits may be used to verify the dates obtained from a facility's records (e.g., the date of shipment). Review should emphasize the admissibility of the affidavit in court. This includes determining that the affidavit was properly executed and that it contributes valid evidence to any contemplated proceeding. The affidavit itself should contain the following: - Identity of the affiant; - The reason why the affidavit was taken; - The pertinent facts in a simple narrative style, arranged In chronological order; and - A concluding paragraph indicating that the affiant read and understood the statement. In addition, any corrections made to the final copy must be ini- tialed by the affiant. • Statements. Similar in most respects to an affidavit except that statements are not taken under oath. Although not having the same weight in court, statements are taken for the same reasons and under the same procedures as an affidavit. Statements can be used to verify data collected during an inspection. For example, a statement may be obtained from a facility representative as to a date of shipment. Review should verify the person's identity and the truth of the statement through a signature or some other writ- ten or verbal acknowledgment. • Printed Matter. This includes any brochures, literature, labeling, or any other printed matter providing information concerning a pes- ticide or pesticidal device including claims, directions for use, contents data, or promotional information. For pesticides, review of the printed matter directly relates to terms and conditions specified in the registration. Printed natter must be identified by Inspector's Initials, date of collection, and related sample number. • Photographs. The documentary value of photographs ranks high as admissible evidence. Clear photographs of a relevant subject, taken in proper light and at proper lens setting provides an objec- tive record of conditions at the time of Inspection. Review must ensure that the photographs are clear, objective, and properly identified. The photographs should be identified by location, pur- pose, date, time, Inspector's initials, and related sample number. This information should be recorded on the photographs, or in the Inspector's field notebook, or both. FIFBA Coapliaace/Eaforcewsnt 4-10 Guidance Manual 1983 ------- Chapter Four Review of Adequacy of Evidence Drawings and Maps. Schematic drawings, maps, charts, and other graphic records can be useful in supporting violation documenta- tion. They can provide graphic clarification of site location rel- ative to height and size of objects, and other information that, in combination with samples, photographs, and other documentation, can produce an accurate, complete evidence package. Review should ensure that drawings and maps are simple and free of extraneous details. Basic measurements and compass points should he -included .to provide. .a, scale-, for interpretation. Recording. Records produced by an electronic or mechanical apparatus can be entered as evidence. Review of charts, graphs, and other "hard copy" should ensure relevance and Identity. The data collected should be identified by date of collection, inspector's initials, and related sample number. Further Processing ------- Chapter Four Review of Adequacy of Evidence Scientific Review. If product defects are noted as a result of laboratory tests, the ID Jacket should be sent by the RCDO to Headquarters. A review will be conducted by Registration Division personnel to determine the sig- nificance of the discrepancy as it relates to the sample's chemical compo- sition, efficacy, or toxiclty. The Registration Division will enter the registration status and pesticide determination on the Enforcement Case Review Form (EPA Form 8500-7). This form will also include the product's accepted name and the name and address of the registrant. Written comments as to labeling discrepancies and sig- nificance of test results are placed on EPA Form 8500-7A.. Copies of the above forms are placed by the Registration Division into the appropriate ID Jacket and, along with testimony from the responsible Registration Division official, may serve as evidence in court. For any violations noted during an enforcement case review, the RCDO should consult the Level of Action Policy section of this manual (Chapter Five) for guidance as to the appropriate enforcement response. Additional Sources of Documentation Frequently, additional information will be needed in order to complete the review of the ID Jacket. In some cases this information will be provided by subsequent reports. If not, the RCDO should seek to obtain the addi- tional information or elaboration from the most knowledgeable source. Additional sources of documentation include: • Establishment Inspection Report; • Inspector's Narrative Report; and • Inspector's Field Notebook. Shipping Documentation Section 8(b) of FIFRA provides authority to Inspect and copy all records showing the delivery, movements, or holding of a pesticide or pestlcidal device. This documentation, which Is often done as a part of a Section 9 Inspection, identifies the responsible party within the stream of commerce who is suspected of a FIFRA violation. Information that night be obtained from shipping records includes: • Identity of pesticide or device; • Quantity sold, received, shipped, or stored; • Dates sold, received, or shipped; FIFRA Coapllance/Eoforceaent 4-12 Guidance Manual 1983 ------- Chapter Four Review of Adequacy of Evidence • Sources of the pesticide or device; and • Transporter of the pesticide or device. Records providing this information include: • Bill of Lading; • Freight Bill; • Parcel Post Cancellation Stamp; • Invoice; • Packing Slip; • Purchase Order; and • Receiving Report. 1 I FIFRA Co«gHanc*/Knf orcenent 4-13 Guidance Manual 1983 ------- Chapter Four Review of Adequacy of Evidence FIFEA CompUance/Enforceaent 4-14 Guidance Manual 1983 **•• ------- Contents 1983 ------- Chapter Four 1 Introduction Upon completion of a Section 9 inspection, pesticide enforcement inspectors are required to organize the documentary evidence gathered during this inspection into a file commonly called the ID (or Sample) Jacket. The ID Jacket file includes all the forms, reports, and documentary evidence secured by .the .inspector relating, to an official pesticide or pesticldal device sample. ;Qnce compiled, the file Is sent .to a -Regional Case Develop- ment Officer (RCDO) who reviews the Inspection results for possible enforcement action. rlFKA co»p u mire/ mtorccaent 4-1 Guidance Manual 1983 ------- Four Introduction FURA CDMpliance/Enforce^nt 4^2 ' Guidance Manual 1983 ------- Chapter Four 2 Inspection File Review To ensure the validity and quality of documentary evidence for an adminis- trative or judicial enforcement proceeding, the RCDO must review the evi- dence for objectivity, adequacy, and proper identification. In some Instances the RCDO will need an enforcement case review, which could . include the verification of the sample's pesticide registration and labeling status, ms -well AS an interpretation of laboratory test results. In all rases, the RCDO must verify that all procedural safeguards were implemented so as not to prejudice a possible enforcement action. Substantiation of Each Violation In most cases, a violation will be substantiated through a combination of evidential sources. The RCDO's review must seek to substantiate each possible violation from the' evidence supplied by the Inspector. Whenever neces-sarj., the JLCDO should obtain from the Inspector additional evidence or Controlled Identification of Each Sample An Important aspect of any review by the RCDO is the determination that all 'i1 1 if i^i 1 T *^**>^ l^^'TyiJ /and yrc^T-ffTff IT ' ' Whenever a sample is taken, the Inspector prepares a Collection Report (EPA Form 3540-7), which describes the sample collection process. Information required for the report Includes: • Type of sample; • Date of collection; • Collection method; PIFRA Ompllance/Baforceaent 4-3 Guidance Manual 1983 ------- Chapter Four Inspection File Review • Description of sample (Including quantity collected, color, tex- ture, viscosity, etc.); • Duplicate samples (If provided); and • Description of procedures for sealing sample. Each ID Jacket will also be identified by a sample number. The RCDO should check the number to see if it corresponds to the ID number on the Collec- tion Report Form. All samples that are to be used as evidence should be sealed with the offi- cial EPA seal (EPA Form 7500-2). The seal is placed on the sample con- tainer by the inspector to help preserve the integrity of the sample. A written receipt (EPA Form 3540-3) describing the sample obtained by the inspector is issued to the appropriate facility representative whenever a sample is taken. The receipt may also be used to verify that a dupllcative sample was given the facility. The ID Jacket may not always include a copy of the receipt. If an enforcement action is considered, a copy may be obtained from the Inspection Report that was filed with the Regional Office. The two types of samples commonly collected are official and Investlga- tlonal. Official Samples. These include samples or documents of pesticides or devices that, if violative, serve as a basis for legal action. In general, an RCDO should ensure that an official sample: • Was collected only from material that had been "packaged, labeled, and released for shipment" (see Glossary); • Was representative of the lot from which it was obtained; and • Was Identified and officially sealed so as to maintain its continu- ity and integrity as court evidence. Official samples include: • Producer/Marketplace Samples. Actual samples of a pesticide or pestlcidal device collected by an Inspector at the producer, whole- sale, or retail level. • Documentary Samples. Copies of the label and/or labeling and copies of any records showing shipment of the product and the re- sponsible parties. • Post-Seizure Samples. Actual samples collected from a lot of mer- chandise that is in the custody of a U.S. court. A court order must be entered before sampling, and these actions must be carried out in accordance with such orders. FIFRA Coapliance/Eiiforceaent 4-4 Guidance Manual ------- Chapter Four Inspection File Review • Induced Samples. Actual samples of pesticides or pesticidal devices that are not obtained by EPA official procedures (e.g., notice of inspection, collection report, etc.). These samples are usually requested by mall. An induced sample is the least desir- able method of obtaining a sample and should be used only when the other methods have been exhausted* • Import Samples. Actual samples of pesticides or pesticidal devices that are offered for importation into the United States from a for- eign port. Proper documentation for import shipments should Include Customsentry.papers,,foreign invoices, and records shoving Movement from the port of entry. • Use Samples. Actual samples of the pesticide that are collected during a use inspection. This type of sample may be field col- lected from a formulated pesticide, diluted pesticide, or as a res- idue from plant material, animal tissue, soil, water, etc. Invest!Rational Samples. These include samples of pesticides or devices collected for special Investigation or -information purposes. These samples need not be collected from lots or stocks that have been packaged, labeled, and released for shipment. No legal action can be taken on investigatlonal samples. FIFRA Compliance/Enforcement 4-5 Guidance Mf""*1 1983 ------- Inspection File Review FCTA CoBpllance/Enf orceaent 4-6 Guidance 1983 ------- Chapter Four 3 Review of Adequacy of Evidence Initial Review of the ID Jacket Once the RCDO has received the ID Jacket, its contents must be reviewed in the ^context of the following considerations: • Adequacy of the documentation (see below); • Significance of violation (see Chapter Five for Level of Action Policy); and • Violative history of the firm (see Chapter Five for Level of Action Policy). Violative history may be obtained from the FIFRA and TSCA Enforcement System (FATES) . Ajgquacy .of .the Jojctn"frit'------- Chapter Four Review of Adequacy of Evidence Contents of the ID Jacket The ID Jacket should normally contain the following items: Label of a Pesticide or Device. The label should either be an actual copy (or photocopy) or a typewritten copy. The label should be identified by sample number, date of collection, inspector initials, and, if appropriate, subsample numbers. Notice of Inspection (EPA Form 3540-2) or Warrant. If an enforcement action is being considered, a copy of the notice of inspection or warrant may be obtained from the Establishment Inspection Report. The notice and/ or warrant should be reviewed to ensure the Inspection adhered to the terms specified in the documents. Receipt for Sample. The written receipt should describe the sample and verify that a duplicate sample, if requested, was given to the facility official. The RCDO should verify sample identification numbers. Collection Report. This is the official report of the sample collection. The following should be verified from the report: • The ID number appearing on the Collection Report should agree with the number on the ID Jacket. For documentary samples, the notation "DOC" will appear after the ID number; for investigational samples, "INV" will appear after the ID number; for post-seizure samples, "P.S." will appear after the ID number; and import samples will be identified by "Import"; • Date of shipment (from transportation records) of the sample; • Amount of the product before sampling (the amount on hand must be less than or equal to the amount snipped); • Descriptions indicating number of samples and method of collection; • Shipper of sample (from transportation records); and • Reason for collection—either to document a suspected violation, or as part of a "Market Basket Survey" of products without accompany- ing documentation. History of Official Sample (EPA Form 3540-17). This document is placed in the ID Jacket by laboratory personnel once the physical cample has been received by the laboratory for analysis. It shows whether the Integrity of the sample has been maintained during its stay at the laboratory. Each time the sample seal is broken and resealed, It mist be noted on the form. It is important for the RCDO to demonstrate that none of the samples Involved in the case preparation have been tampered with or contaminated during collection, transit, storage, or analysis. An accurate accounting FIFKA Compliance/Enforcement 4-8 Guidance Manual 1983 ------- Chapter Four Review of Adequacy of Evidence must be maintained to trace the possession of each sample from the moment of collection to its introduction as evidence. Accountability can be checked by reviewing the following documents: • Receipt for sample; • Collection report; and • History of official sample. Laboratory Test Methods. Test .methods employed in the analysis of pesti- cide or -pesticidal device samples fall into two categories, official and unofficial. • Official Test Method. Refers to a test method accepted by a recog- nized standard-setting organization, such as the Association of Official Analytical Chemists (AOAC) or the American Society for Testing and Materials (ASTM). -» Unofficial Test Method, Refers to a method that has not as yet been accepted as a standard method but is employed by EPA in the analysis of a sample because other reliable test methods are not available. Extreme care and judgment should be exercised In preparing enforcement cases when unofficial test methods are used as the basis for evidence of a violation of the FIFRA. Consultations with Headquarters Case Development Officers (HQCDOs) are strongly recommended before proceeding with enforce- ment actions in these cases. Laboratory Test Results. Test results are placed in the ID Jacket upon • Sample Report of Analysis (EPA Form 3540-5), which shows the chemi- cal composition of the sample collected versus composition guaran- teed by the registrant. Usually a cross-contamination will be conducted by the laboratory and the percentage of contaminants, If any, noted; and/or • Efficacy test, which shows the effectiveness .of the product. ^Evtdcut.lsl Documentation. "Suspected violations may also be documen- ted by the inspector using the following support methods: • Affidavit. Sworn statements taken by the inspector relating to personal first-hand knowledge of a potential violation. The affi- davit may be used to substantiate the violation or to set the cir- cumstances surrounding -the violation. £kr*ffll review saonld be *Bde«f>£be; affidavit far evidence Ja :*oppart of «n -enforcement action. The person making the affidavit must sign it and be able to personally verify the facts contained in the statement. FIFBA CoBpllance/Enforceaent 4-9 Guidance Manual 1983 ------- Chapter Four Review of Adequacy of Evidence The object of an affidavit is to obtain a clear and concise written record of factual information relating to a suspected violation. The oath taken by the person making the affidavit serves to sub- stantiate the truth of the statement. Affidavits may be used to verify the dates obtained from a facility's records (e.g., the date of shipment). Review should emphasize the admlssibllity of the affidavit in court. This includes determining that the affidavit was properly executed and that it contributes valid evidence to any contemplated proceeding. The affidavit itself should contain the following: - Identity of the affiant; - The reason why the affidavit was taken; - The pertinent facts in a simple narrative style, arranged in chronological order; and - A concluding paragraph indicating that the affiant read and understood the statement. In addition, any corrections made to the final copy must be ini- tialed by the affiant. • Statements. Similar in most respects to an affidavit except that statements are not taken under oath. Although not having the same weight in court, statements are taken for the same reasons and under the same procedures as an affidavit. Statements can be used to verify data collected during an inspection. For example, a statement may be obtained from a facility representative as to a date of shipment. Review should verify the person's identity and the truth of the statement through a signature or some other writ- ten or verbal acknowledgment. • Printed Matter. This includes any brochures, literature, labeling, or any other printed matter providing information concerning a pes- ticide or pesticidal device including claims, directions for use, contents data, or promotional Information. For pesticides, review of the printed matter directly relates to terms and conditions specified in the registration. Printed matter must be Identified by inspector's initials, date of collection, and related sample number. • Photographs. The documentary value of photographs ranks high as admissible evidence. Clear photographs of a relevant subject, taken in proper light and at proper lens setting provides an objec- tive record of conditions at the time of Inspection. Review must ensure that the photographs are clear, objective, and properly Identified. The photographs should be identified by location, pur- pose, date, time, Inspector's initials, and related sample number. This information should be recorded on the photographs, or in the inspector's field notebook, or both. FXFBa. Compliance/Enforcement 4-10 Guidance Manual 1983 ------- Chapter Four Review of Adequacy of Evidence Drawings and Maps. Schematic drawings, maps, charts, and other graphic records can be useful in supporting violation documenta- tion. They can provide graphic clarification of site location rel- ative to height and size of objects, and other information that, in combination with samples, photographs, and other documentation, can produce an accurate, complete evidence package. Review should ensure that drawings and maps are simple and free of extraneous details. Basic measurements and compass points should be included to provide a scale for interpretation. Mechanical Recording. Records produced by an electronic or mechanical apparatus can be entered as evidence. Review of charts, graphs, and other "hard copy" should ensure relevance and identity. The data collected should be identified by date of collection, inspector's initials, and related sample number. Further Processing of the ID Jacket—Enforcement Case Review _ Once the ID Jacket has been initially reviewed by the RCDO, further devel- opment of the case may be required at Headquarters. If so, the ID Jacket should be sent to the appropriate HQCDO who serves as coordinator for the enforcement case review process. Aspects of the case that may require fur- ther processing include: Product Registration Status. The status of a pesticide (registered or not registered) is determined by the Registration Division after a search of their files. In some instances the Region may also wish to know whether a -pesticide registration d» suspended or •••"•••T'W Pesticide or Device Determination. When a suspected pesticide is not registered or is not under a Section 5 experimental use permit, then a determination is made by the appropriate Registration Division official of whether the product is a pesticide. Devices are reviewed to determine if they are pesticidal In nature and if so whether or not they are exempt from EPA regulation. trf "'•11 ;|MHTti I'dr T**«^ljf t*fJ3*»***4 -OT;prTt .of inspection should be compared with the latest EPA-accepted label for that pesticide and any major discrepancies noted. If the latest accepted label is not present at the Regional Office, it should either be requested from Headquarters or the corresponding ID Jacket should be sent to Headquarters for review. In addition, questionable interpretations of label statements should be classified by the Registration Division before the Regional FLFRA Cowpllance/Enforceaent 4-11 Guidance Mam">1 1983 ------- Chapter Four Review of Adequacy of Evidence Scientific Review. If product defects are noted as a result of laboratory tests, the ID Jacket should be sent by the RCDO to Headquarters. A review will be conducted by Registration Division personnel to determine the sig- nificance of the discrepancy as It relates to the sample's chemical compo- sition, efficacy, or tozlclty. The Registration Division will enter the registration status and pesticide determination on the Enforcement Case Review Form (EPA Form 8500-7). This form will also include the product's accepted name and the name and address of the registrant. Written comments as to labeling discrepancies and sig- nificance of test results are placed on EPA Form 8500-7A. Copies of the above forms are placed by the Registration Division into the appropriate ID Jacket and, along with testimony from the responsible Registration Division official, may serve as evidence in court. For any violations noted during an enforcement case review, the RCDO should consult the Level of Action Policy section of this manual (Chapter Five) for guidance as to the appropriate enforcement response. Additional Sources of Documentation Frequently, additional information will be needed in order to complete the review of the ID Jacket. In some cases this information will be provided by subsequent reports. If not, the RCDO should seek to obtain the addi- tional information or elaboration from the most knowledgeable source. Additional sources of documentation Include: • Establishment Inspection Report; • Inspector's Narrative Report; and • Inspector's Field Notebook. Shipping Documentation Section 8(b) of FIFRA provides authority to Inspect and copy all records showing the delivery, movements, or holding of a pesticide or pestlcldal device. This documentation, which is often done as a part of a Section 9 inspection, identifies the responsible party within the stream of commerce who is suspected of a FIFRA violation. Information that night be obtained from shipping records Includes: • Identity of pesticide or device; • Quantity sold, received, shipped, or stored; • Dates sold, received, or shipped; FIFRA CoBpllance/Enforceaent 4-12 Guidance Manual 1983 ------- Chapter Four Review of Adequacy of Evidence • Sources of the pesticide or devicej and • Transporter of the pesticide or device. Records providing this information include: • Bill of Lading; • Freight Bill; • Parcel Post Cancellation Stamp; • Invoice; • Packing Slip; • Purchase Order; and • Receiving Report. FIFEA Compliance/Enforcement4^DGuidance Manual 1983 ------- Chapter Four Review of Adequacy of Evidence FZFRA Coapllance/Enforceaent4-14Guidance Manual 1983 ------- Chapter Five Determination of Appropriate Enforcement Response Chapter Contents _ Page 1 Introduction 5-1 2 Level of Action Policy 5-3 Advertising Letters 5-3 Notices of Detention 5-4 Notices of Warning 5-4 Terminations of Establishment Registrations 5-5 Denials, Suspensions, Modifications, or Revocations of Applicator Certifications 5-6 Recall Requests 5-8 Stop Sale, Use, or Removal Orders 5-10 Civil Administrative Penalties 5-13 Injunctions 5-14 • • 5—15 5-16 Exhibit 5-1 : Efficacy Standards and Level of Action Guidance for Disinfectants and Rodenticides 5-18 Exhibit 5-2: Criteria for Determining the Gravity of a Use Violation for Purposes of a Certification Action 5-21 FlFMA Compliance/Boxorceaent 5-1 Guidance Manual 1983 ------- Chapter Five Contents FIFRA Co«pl±aiice/Enforce«ent ------- Chapter Five 1 Introduction Once the documentation of a violation is complete and EPA personnel have determined that an enforcement action is warranted, EPA must decide upon the appropriate level of action called for by the severity of the viola- tion. There are two categories of action—administrative and judicial. Generally, the Agency uses administrative actions for violations of a lesser nature, for first-time violators, or to obtain relief on short notice,, &a in the ;ca«e of stop sale, use, and removal orders. The Agency reserves judicial actions for use in violations of an especially egregious nature that result in serious harm to human health or the environment, and for willful or repeated violations. Administrative levels of action Include the following: • Advertising letters; • Notices of detention under Section 17(c); • Notices of warning under Sections 9(c)(3) and 14(a)(2); • ••;"• flGeinlaationsvof «stabXlsh«eat7egl«CT«tlons Bonder 40 C.T.K. $167.3; • Denials, suspensions, modifications, or revocations of applicator certifications under 40 C.F.R. 1171.11; • Recall requests; • Stop sale, use, or removal orders under Section 13(a); and -:-;,-.« :d*U «dadal«tx*£ive ^enaltlea under Section 14(a). The criteria for the use of each of the above levels of action are dis- cussed later in this chapter. Specific procedures for preparing and issuing these actions are found in Chapter Six, "Administrative Enforcement Actions: Notices of Violation and Administrative Orders," and Chapter Seven, "Administrative Enforcement Actions: Civil Penalty Proceedings*" 5-1 QafdOTC? Mr""*1 1983 ------- Chapter Five Introduction Judicial actions may involve either civil or criminal proceedings. Civil proceedings include: • Injunctions under Section 16(c); and • Seizures under Section 13(b). Criminal proceedings are authorized under Section 14(b). The criteria for the use of Judicial actions are also found later in this chapter. Chapter Eight, "Judicial Enforcement: Civil Actions," and Chapter Nine, "Judicial Enforcement: Criminal Actions," discuss procedures for civil and criminal judicial proceedings. In addition, Exhibit 5-1 contains level of action guidance applicable to efficacy standards for hospital or medical use disinfectants and rodenticides. FUBA Compliance/EnforcementP2 Guidance Manual 1983 ------- Chapter Five 2 Level of Action Policy Advertising Letters An advertising letter is /.a letter Issued by EEA as notice to a company that collateral literature concerning a product (I.e., literature or advertising that does not accompany the product) bears unaccepted pesticide statements or pesticide or device claims. An advertising letter may be issued by the Agency upon receipt of or knowledge of such literature and without EPA having in its possession an official sample of the pesticide or device accompanied by the literature. An advertising letter should identify: • The literature; and • The unaccepted statements (If related to a registered product), the pesticide claims (if related to an unregistered pesticide), or the -device claims ------- Chapter Five Level of Action Policy Notices of Detention Section 17 of FIFRA authorizes EPA to refuse admission of a pesticide or device being imported Into the United States if EPA determines that such pesticide or device violates any provisions of the Act* This refusal is known as a Notice of Detention and Hearing. Upon receiving a copy of the notice, the Department of the Treasury, through the Customs Service, will refuse delivery to the consignee and will oversee destruction of any pesti- cide or device refused delivery that is not exported by the consignee within 90 days from the date of the notice. However, under the Customs regulations for the enforcement of Section I7(c) of FIFRA, the District Director of Customs may release a shipment to the Importer or the Impor- ter's agent before an EPA inspection of the shipment. Such a release occurs only upon execution of a bond in the amount of the value of the pesticide or device, plus duty. Should the shipment subsequently be refused entry and the importer or agent fails to return the pesticide or device, the bond is forfeited. A shipment released to the Importer cannot be used or otherwise disposed of until EPA makes a determination of the admlssibility of that shipment. Notices of Warning Section 14(a)(2) Notices of Warning Section 14(a)(2) of FIFRA requires EPA to use a notice of warning In re- sponse to the first civil offense committed by a private applicator or other person not covered under Section 14(a)(l). Section 14(a)(l) covers registrants, commercial applicators, "for hire" applicators, wholesalers, dealers, retailers, and other distributors. "For hire" applicators are applicators who apply general use pesticides as a service In controlling pests but who do not deliver any unapplied pesticides. Section 9(c)(3) Notices of Warning Since the Agency Is attempting to concentrate its pesticides enforcement resources on serious violations and repeat offenders, EPA may also issue notices of warning under Section 9(c)(3) of FIFRA In response to first-time violations committed by those persons covered by Section 14(a)(l), with the following exceptions: • The Agency should pursue a remedy more severe than a warning in response to first offenses that result in (1) a real risk to humans or the environment or (2) any actual harm stemming from the viola- tor's failure to exercise due care (i.e., the degree of care a rea- sonably prudent person would exercise in slmlllar circumstances); and FIFRA Govp.Ll.ance/Enforcement 5-4 Guidance M**"*' 1983 ------- Chapter Five __^__^_______ Level of Action Policy • The Agency should apply a remedy other than a notice of warning in the case of a violation by a person who has already been placed on notice of the existence of FIFRA or its requirements. (EPA will consider a person to have been placed on notice if that person has been subject to a formal inspection by EPA personnel or has Interacted with the Agency by obtaining a product registration, an establishment registration, or any other similar license, permit, or certification.) The Agency, In Its discretion, may decide to issue a Section 9(c)(3) warning notice against persons .included in the latter exception or against a repeat violator whose second violation is an extremely minor one, if EPA enforcement officials believe that Justice will be served by employing such a remedy. Termination of Establishment Registration The regulations related to the registration of pesticide-producing estab- lishments (40 C.F.R. S167.3) state that an establishment registration will remain in effect so long as the establishment continues to submit annual pesticides reports. If the establishment fails to submit a report in any year, the Agency may issue either a notice of warning or a civil penalty, based on the provisions of FIFRA Sections 7(c)(l) and 12(a)(2)(L).* A notice of warning would be the typical action for a newly registered estab- lishment that failed to submit its initial pesticides report. The Agency should initiate a civil penalty in response to the failure to file a pesticides report on the part of an establishment that previously filed at least one annual report and is thus on notice as to its continuing iblHty *'" ^***^TH^ ^ jt**i**t1^ - tio^ff not an annual pesticides Teptart -within 20 days after the date of receipt of the notice of warning or civil penalty, EPA will initiate procedures to terminate the establishment registration, independent of the other action. Non-Enforcement Termination Termination of establishment registration may also occur upon request of tos"gone or vlll go out of "business, no longer produces pesticides, or otherwise no longer falls under the purview of FIFRA Section 7. In such eases the procedures for terminating establishment registration are 30 4ay> of notification of establishment registration; subsequent reports are due by February 1 of each year. The Agency may, however, grant discretionary extentlons of up to 30 days for filing a report before the report is considered delinquent. ump 11 ance/ Bnzorccaent 5-5 Guidance Mar*"*1 1983 ------- Chapter Five Level of Action Policy strictly technical and are based on the operating procedures of the FIFRA and TSCA Enforcement System (FATES). Termination of establishment regis- tration in such situations should not be confused with termination for cause. Denials, Suspensions, Modifications, or Revocations of Applicator Certifications The regulations relating to the certification of pesticide applicators (40 C.F.R. Fart 171) authorize EPA to deny, suspend, modify, or revoke feder- ally issued applicator certifications If the certificate holder violates FIFRA or its regulations. The Agency views an enforcement action affecting certification status as a very strong measure, to be taken only when the "public health, interest or welfare warrants immediate action" [40 C.F.R. S171.11 (f)(5)(l)J. Therefore, EPA will deny, suspend, modify, or revoke a certification only in response to serious violations or against persons with a history of noncompllance. The Agency may take any of these actions if it determines that an applicant for or holder of a certification has: • Been convicted under Section 14(b) of FIFRA; • Been subject to a final order Imposing a civil penalty under Section 14(a); • Misused a pesticide; • Made available for use, or used, a registered pesticide classified for restricted use.other than in accordance with Section 3(d); • Refused to keep and maintain records required by 40 C.F.R. Part 171; • Made false or fraudulent records, invoices, or reports; • Failed to comply with any limitations or restrictions on or in a previously issued certificate; or • Violated any other provision of FIFRA or its regulations. Denial/Revocations The denial or revocation of a certification not only deprives an applicator of the authority to apply restricted use pesticides but also, as compared to suspension of a certification, forces the applicator to take additional steps to acquire or re-acquire certification. In addition, the Agency will not consider an application to acquire or re-acquire certification for a period of not less than six months following denial or revocation. Thus EPA will deny or revoke a certification only where a violation has resulted ------- Chapter Five Level of Action Policy In a fatality or created an Imminent danger of a fatality, where the viola- tor's certification has been suspended as a result of a previous violation, or where a person has made fraudulent records or reports. Suspensions When considering Invoking the less severe alternative of suspending a cer- tification, EPA personnel must determine whether it Is appropriate to pur- sue a suspension and for how long such suspension should be in effect. These determinations will depend upon the gravity of the violation in question. Suspension (Misuse Violation). In suspending a certification due to an incident of misuse, EPA will refer to criteria for assessing the gravity of a use violation (see Exhibit 5-2). The gravity of a use violation is a function of: • The risk of harm posed to human health and the environment by the ***j t*? -8 1 Ion ? • The degree of misconduct exhibited by the violator. The Agency will assign weightings, based on the gravity criteria, for each use violation relative to the pesticide involved, the harm to human health and/or to the environment, the history of noncompliance , and the culpabil- ity of the violator. (For purposes of this section of the manual, EPA will not distinguish between commercial and private applicators. Consideration of applicator status is Inherent in the policy in that suspensions have a more substantial Impact on commercial applicators, affecting their primary business activity.) The Agency will use the gravity value thus obtained to decide whether and for how long to suapend a certification, in accordance the following table: Total Gravity Value Enforcement Remedy A or below No action or Notice of Warning 5 to 8 Suspension of up to 2 months 9 to 12 .Suspension of .nbetmeen --2 -and 4 south 13v«r aiwve Suspension of Aataam 4 moA-•^"•p To determine whether the term of a suspension should be at the higher or lower end of the given ranges, EPA will consider any gravity-related fac- tors not accounted for in the gravity criteria. In addition, EPA will con- sider Xbe the v«TO3ic«tor* -;= Applicators ^dho 'wooM -1>e minimally affected by a suspension, such as those who apply restricted use pesticides infrequently, should receive longer suspensions than applicators whose day-to-day rLFHA. GoapJJ.ance/Enxorceaent 5-7 ^ii^rcf* Ma*1'"*1 1983 ------- Chapter Five ____^_ Level of Action Policy business activities would be severely disrupted by the loss of their certifications. Suspensions should generally be pursued against individual applicators in lieu of a Section 14(a) civil administrative penalty. This, however, does not preclude EPA from issuing both a suspension as well as issuing a warning letter or from assessing a civil penalty against the employer of the applicator in addition to suspending the certification of the applica- tor. Suspension (Recordkeeping Violation). EPA may also suspend certifications of commercial applicators who violate restricted use pesticides record- keeping requirements [see 40 C.F.R. Sl71.11(c)(7); 40 C.F.R. Sl71.11(f)(1) (ill)]. These violations do not lend themselves to analysis utilizing gravity of harm criteria. Consequently, EPA will suspend the certifica- tions of persons who fail to maintain restricted use pesticides records based solely on gravity of misconduct considerations. The Agency will . assess suspensions of up to two months for the second independent violation resulting from the failure to maintain restricted use pesticides records. For each additional violation, two months may be added to the term of the suspension up to a limit of six months. In cases where the violation Involved keeping fraudulent records (i.e., where the violator intentionally concealed or misrepresented the true circumstances and the extent of the use of restricted use pesticides), EPA may revoke the violator's certifica- tion in response to the initial infraction. If EPA decides to suspend certification, it must notify the applicator of the time period during which the suspension will be in effect. In order for the suspension to function as a deterrent, the suspension should take effect during the time when the applicator is most likely to be applying restricted use pesticides. - Recall Requests No explicit authority exists in FIFRA for the recall of products. The effectiveness of a recall action, therefore, Is contingent on the cooperation of the involved company. Recalls should be initiated by EPA In all cases where available Information Indicates that the product is either potentially hazardous when used as directed or ineffective for the purposes claimed. The Agency should consider a recall of a product when, among other things, its use as directed is likely to result in: • Injury to the user or handler of the product; • Injury to domestic animals, fish, wildlife, or plant life; snt 3-8 Guidance Manual 1983 ------- Chapter Five Level of Action Policy • Physical or economic injury because of ineffectiveness or due to the presence of actionable residues; or • Identifiable adverse effect on the environment. EPA personnel must view a request for recall as a serious and extraordinary matter and must make a request for recall of a product only in those cases where the evidence clearly supports such action* The initial decision that a product should be withdrawn from the market will be based on Information In the sample file Including laboratory analyses, staff evaluations and opinions, and such other information, as.may be available.and relevant. All Information supporting & recall decision auat be Included in the official file. Formal and Informal Recalls There are two types of recalls—formal and Informal. Formal recalls are used for more serious problems when it is essential that EPA regional per- sonnel follow up the recall -with a visit £o the company, formal recall Involves EPA monitoring, detailed reporting by the company involved, and notification to State officials. This type of recall is normally accom- panied by another enforcement action, generally a civil penalty. The Agency uses informal recalls in cases where a recall is necessary but the level of potential hazard is not great or when it is unlikely that sig- nificant amounts of the defective product remain in the marketplace. An informal recall is conducted entirely by the company involved with no moni- toring by EPA or State officials. Level of Recall Determination The l«vel -of recall is the point in the distribution chain from which the product is to be recalled. The determination of that point is based on the potential hazard, use pattern, and distribution pattern of the product. The following recall levels should be considered: • Wholesale or First Point of Distribution. This will normally Include all informal recalls and those formal recalls In which the product distribution is limited ftp^ cppf^'fTTtly -t^'-fM^gi?*"*^ dft"— ger Is.lov. • Retail Level. This will be the normal level for most formal re- calls. • User Level. This level will be requested only In cases in which there is a known serious hazard to human health or the environment. Compliance/Enforcement pg Guidance Manual 1983 ------- Chapter Five Level of Action Policy Scope of the Recall EPA must also consider the scope of the recall (i.e., the amount of the product that the recall will cover). In the case of labeling violations, the recall should include all of the product bearing the unacceptable labeling. For chemical violations, the recall should Include all of the product bearing the same batch code(s) as the sample(s) found in viola- tion. If the product is uncoded, EPA will determine the scope of the recall after contacting the responsible company. After reviewing the firm's manufacturing and shipping records, EPA personnel should be able to determine a range of manufacturing dates to include in the recall. The recall of a defective product by the manufacturer or distributor is the most effective and efficient means of removing such a product from the mar- ket. However, since it is strictly voluntary, the success of the recall program depends on the Industry's knowledge that: • EPA will make a recall request only In those cases where there Is a likelihood of physical or economic injury from the use of a product according to label directions; • The Agency will use all legal means available to It to support or supplement any recall request, including stop sale, use, or removal orders, seizures, and civil penalties; and • State officials will cooperate with the Agency in the removal of such products. Stop Sale, Use, or Removal'Orders A stop sale, use, or removal order (SSURO) should be Issued by EPA if the violation is of an ongoing nature and threatens to cause serious or widespread harm. This remedy Is not designed to prevent future violations, but rather is intended to limit the amount of harm that might result from a violation. In order to preserve the bearing rights of the recipient of an SSURO, EPA should supplement the order with a civil penalty assessment. An SSURO Is among the most expedient and effective remedies available to EPA In its efforts to prevent Illegal sale, distribution, and use of pesti- cides* Its advantages over other actions (such as seizures) are that: • It may be issued without prior adjudication of the violative char- acter of the product (i.e., EPA may issue an SSURO simply when it has reason to believe that the product is in violation of the Act); • It is easier to prepare and issue than a seizure; r Enforcement5-10Guidance Manual 1983 ------- Chapter Five Level of Action Policy • It can be written so as to include future amounts of the product that may come into the custody of the person on whom the SSURO is served; and • It can be easily adapted to particular circumstances. Criteria for Use The language of Section 13(a) confers broad authority upon EPA to issue SSUROs. The Agency may issue an,SSURO when any one of three situations exists: • If, upon inspection or testing, EPA believes a product is in viola- tion of the Act; • If EPA believes that a product has been or is intended to be dis- tributed or sold in violation of the Act; or .• If EPA has /*a»vM»ii^ or suspended the registration of a product. An SSURO is ordinarily issued by EPA without prior notice to the person served. Because an order is issued without notice, the actual or potential danger to human health or the environment posed by the vlolative product or situation must be both serious and imminent* In addition, the danger must require such urgent relief that there is no time to seek other remedies or that other administrative remedies would be inappropriate. Accordingly, EPA officials must observe stringent guidelines in determining whether issuance of an SSURO is appropriate, as outlined below. Mandatory Issuance of an SSURO. The Agency must issue an SSURO against persons who own, control, or have custody of pesticides in the .following categories: • Pesticides whose registrations have been cancelled or suspended by EPA, except cases In which the Agency has permitted the use of existing stocks, or where continued marketing presents no human health or environmental hazard; • Pesticides for which there is reason to believe present a potential hazard tO. W**'n Or They are not registered, or are so grossly overf emulated or adulterated, as to present a serious health hazard, or They are packaged in Improper or damaged containers, or are so Inadequately labeled, as to make safe or effective use unlikely or impossible; fVnipllniirr/TTnfnrcrarnt ' 5-11 <><^ffrr*> fi^Tumi ]Qip ------- Chapter Five Level of Action Policy • Pesticides or devices with labeling that is materially misleading or fraudulent and, if observed by a user, is likely to cause a life-endangering health hazard or serious adverse environmental condition. (A pesticide lacking a restricted use label is an especially serious labeling violation.) This provision includes labeling for products that: - Are Ineffective for the purposes claimed, - Are so chemically deficient as to affect deleteriously the pro- duct's efficacy, as determined by laboratory test results, or - Bear false or misleading safety claims; • Pesticides or hazardous devices* that are in violation of the Act and are the subject of a voluntary recall, but which the respon- sible party refuses to remove, is recalcitrant in removing, or is unable to remove from channels of trade; and • Pesticides or hazardous devices that are in violation of the Act and for which a civil penalty has been issued but which have not been brought into compliance. Discretionary Issuance of an SSURO. EPA may exercise its discretion In issuing an SSURO in cases where a product either is In violation of the Act or is intended to be distributed or sold in violation of the Act, and the gravity of the violation is less than that required for issuance of a mandatory SSURO. In addition to an analysis of the relative severity of the violation (or lack thereof), the following factors should be considered: • Whether the violation is another in a series of violations by the producer or distributor. In cases of recidivism, of uncorrected violations previously brought to the individual's attention, or of repeated negligent conduct, an SSURO may be appropriate where other enforcement remedies have failed to bring about corrective action or where it is deemed necessary to prevent continued marketing of the violatlve product; • Whether the violation is easily corrected* If it appears that the individual is cooperative and can easily remedy the violation, an SSURO may be unnecessary; and * A hazardous device is one presenting a direct threat to human health or the environment by its use (e.g., a water treatment device whose labeling makes false, misleading, or fraudulent claims to purify raw well water or other untreated water supplies). For nonhazardous devices (e.g., an electromagnetic rodent repelling device) that are misbranded, Agency policy is to complete civil penalty proceedings before issuing an SSURO. See December 19, 1979 Memorandum: "Enforcement Actions Concerning Nonhazardous Pesticide Devices." FJFSA Compliance/Enforcement 5-12 ------- Chapter Five Level of Action Policy • Who has custody of the product. An SSURO may be more appropriate, and a violation more immediately cured, if the vlolative product is found at the producer level rather than at the retail level. In all other cases, EFA should consider an alternative enforcement remedy available under FLFRA. Use of SSURO for Minor Violations While EPA will usually reserve, the use of an SSURO to relatively serious violations, the need to Issue an SSURO may arise in certain cases involving minor violations. For example, in the face of continued and repeated minor violations, or when several minor violations appear together on a label, EPA may decide to issue an SSURO to ensure that the product will be distributed only in compliance with the Act. Alternative Approaches JIven In cases «here the existence of a serious violation would justify the issuance of an SSURO, the Agency may consider the use of alternative approaches to achieve compliance. For example, certain pesticide labeling violations can be rectified through a voluntary recall by the manufacturer, and this may be the most expeditious way to prevent any harm to human health or the environment. Thus, in certain cases that could legitimately call for the Issuance of an SSURO, particularly those concerned with labeling violations, EPA might first consider contacting the appropriate responsible party and negotiating a voluntary recall. Civil Administrative Penalties A civil penalty, as authorized by Section I4(a) of FIFRA, Is the remedy of choice for most violations. A civil penalty should be proposed where the violation presents (a real but not an extreme and unreasonable) risk to humans or the environment; is likely to be an isolated occurrence; was apparently committed as a result of ordinary negligence, Inadvertence, or P VP Involves a first offense under the Act by any registrant, commer- cial applicator, "for hire" applicator, wholesaler, dealer, re- taller, or other distributor (no prior warning Is required by FIFRA for violators In this category); or Involves a private applicator or other person, other than any j>arty . specified In Cfae :flz«t category, wholiBS zcced-red a .?riar warning or -cltatltjn -for * ^rlt>l«tlon of TTFRA. ------- Chapter Five Level of Action Policy Injunctions Section 16(c) of FIFRA gives EPA the authority to Initiate injunctive actions before district courts.* Because an Injunction Is an extraordinary form of relief, the Agency's arguments must be clear and compelling. In Initiating a permanent injunction action, EPA must Indicate to the court that: • The Agency's administrative or other judicial enforcement remedies would be Inadequate either at restraining the violation or at pre- venting unreasonable risk to human health or the environment; • The Agency has, in fact, already diligently exercised all appro- priate administrative remedies (such as SSUROs and civil penal- ties), yet the violation continues unabated; and • Irreparable injury, loss, or damage will result if relief is not granted. In the case of a preliminary injunction or temporary restraining order, the Agency must additionally demonstrate that: • Immediate and Irreparable Injury, loss, or damage will result if relief is not granted; and • There is a likelihood of success at trial, based on facts before the court. Under FIFRA, there are a number of specific circumstances that may justify Injunctlve relief. These include but are not limited to: • The violation of a Section 6 suspension order; • The violation of an SSURO where a civil penalty or criminal prose- cution would not provide a timely or effective remedy to deter fur- ther violations; • There Is continued production, shipment, sale, or use of an unreg- istered pesticide after the Agency has taken civil or criminal action; and These actions may consist of permanent Injunctions, preliminary injunc- tions, or temporary restraining orders. These types of injunctions are discussed in more detail in Section 4 of Chapter Eight. FIFBA CbBpllance/Enforceaent 5-14 Guidance Manual 1983 ------- Chapter Five Level of Action Policy The Agency has exercised an enforcement remedy and a person con- tinues to make available for use a restricted use pesticide other than in accordance with FIFRA Section 3(d), or continues to use a pesticide In a manner inconsistent with its labeling or In a manner contrary to an experimental use permit. Seizures Section 13(b) of FIFRA gives EPA the authority to Initiate in rem condemna- tion proceedings In district court. Once a court grants the Agency's request for authority to conduct a seizure, FIFRA Section 9(b) authorizes duly designated Agency employees to obtain and execute warrants for the purpose of seizing any pesticide or device that is in violation of the Act. Since seizures are Judicial actions directed against vlolatlve products rather than against individuals, EPA may Initiate actions in court against: • A pesticide that is adulterated, misbranded , unregistered, not colored or discolored as required, or bears claims or directions for use that differ from those made in connection with its regis- tration; • A device that is misbranded; or • A pesticide or device that causes unreasonable adverse effects upon the environment, even when used in accordance with requirements imposed by the Act. The Above ^ezaapl«s «re eiaHar ; to tnose that vould lead 'the Agency to ±n±- £l*£e an 5SURO. Because an SSDRO gan be effected In less time and with less preparation than that required for a seizure, it Is the preferred remedy In terms of expediency. Nevertheless, the Agency should consider initiating a seizure In the following circumstances: • The Agency has issued an SSDRO, but the recipient of the order has not complied with it; ,-*• ••jJB»..«af«acy::?has ••reason '.to %ell«ve tisa£ ^person, If lasued an SSDR0, not comply 'With It; • There exists a pesticide so hazardous that it should be removed from the marketplace or place of use; • The seizure will be used to support a recall; or •• at Is necessary to 'dispose «f jmdac&s ccing held under van SSTJRO for 'which the responsible party has taken no corrective action and has expressed an Intent not to take corrective action. FIFRA Compliance/Enforcement 5-15 Guidance Manual 1983 ------- Chapter Five Level of Action Policy Criminal Proceedings Section 14(b) of FIFRA provides EPA with the authority to proceed with criminal sanctions against violators of the Act, subject to the following distinctions: • A registrant, commercial applicator, wholesaler, dealer, retailer, or other distributor who knowingly violates the Act is subject, upon conviction, to a fine of not more than$25,000, or imprison- ment for not more than one year, or both. • A private applicator or other person not Included above who know- ingly violates the Act is subject, upon conviction, to a fine of not more than $1,000, or Imprisonment for not more than 30 days, or both. The Agency may Initiate criminal proceedings in every case in which EPA can meet the stringent requirements of evidence and proof leading to a convic- tion. However, Agency policy, as well as pragmatic resource considera- tions, argues against the use of criminal sanctions In any but the most serious Instances of environmental misconduct, as determined by the nature of the violation, the history of compliance on the part of the responsible person, or the seriousness of the environmental consequences. Considerations There are a number of specific factors that the Agency must carefully con- sider before proceeding with a criminal prosecution. (Chapter Nine, "Judicial Enforcement: Criminal Actions," addresses these considerations in much greater detail.) Knowledge. The Agency must determine that the violator In question know- ingly violated the statute. That is, there must be evidence of intent in the commission of the violative act, rather than it merely being the result of accident or mistake. Seriousness. Criminal actions should be considered for the most serious types of environmental misconduct. This consideration will be judged by reviewing the extent of environmental harm or human health hazard that resulted from, or was threatened by, the prohibited conduct. Factors such as the duration of the conduct and the toxic!ty of the pollutants are considered. Also of significance in assessing the seriousness of the conduct Is the impact—real or potential—upon EPA's regulatory function. Deterrence. The Agency must consider the Importance of and need for deter- rence of criminal conduct, either on the part of a specific person, or on the part of the larger community. In the case of a serious and willful violation, the Interests of deterrence may well best be served by the Imposition of criminal sanctions. 5-16 ------- Chapter Five Level of Action Policy Compliance History* The compliance history of the person who is the sub- ject of possible criminal proceedings will enter into the Agency's deliber- ations. While a history of noncompliance is not requisite for pursuing criminal sanctions, certainly criminal prosecution becomes more appropriate when a history of noncompliance exists. Simultaneous Actions. The Agency may consider whether there is a need for criminal enforcement proceedings contemporaneous with a civil or adminis- trative enforcement action, or whether one type of action alone will serve the situation in question. While simultaneous proceedings are permissible, and there may be very compelling reasons for pursuing both, the legal and practical difficulties Inherent In so doing argue against such an approach except in the most extraordinary circumstances. Use of Criminal Proceedings The Agency has identified a number of specific situations that may be considered of such a serious nature that criminal prosecution Is particularly appropriate. To.list these situations, however, should not be viewed , :«s pr<*cl ud ing crl ai na 1 .prosecution in circumstances not Included below: t • Failure to report Information on the unreasonable adverse effects of a registered pesticide; • Falsification of records; • Violation of an order suspending or cancelling a product registration; • Violation of an SSURO; -:<• Unlawful use«T)f pesticides; and • Illegal distribution of unregistered pesticides. illance/Enforcement 5-17 ~" Guidance ------- Chapter Five Exhibit 5-1 Efficacy Standards and Level of Action Guidance for Disinfectants and Bodentlcldes Efficacy standards have been developed and are being utilized by the Agency for hospital or medical use disinfectant products and rodentl- cldes. The efficacy standards and level of action guidance for these two types of pecticides are summarized below. However, for the com- plete disinfectants laboratory testing procedures and level of action guidance, refer to December 17, 1980 Memorandum: "Regulation of Public Health Belated Disinfectant Products." Additionally, for both disin- fectants and rodentlcides, consult the civil penalty matrix In Appendix 6 for the appropriate civil penalty calculations. Disinfectants Only hospital or medical use products that make claims for Salmonella choleraesius, Staphylococcus aureus, or Pseudomonus aeruglnosa* are tested. Level I Testing In Level I testing, 60 carriers must be tested against each of the above organisms with each of three samples, representing three different batches. This amounts to 180 carriers per sample; a total of 540 carriers. • Disinfectant Sample(s) Performance Standard; A sample is determined to fail efficacy testing if organisms on 2 or more of the 60 carriers are not destroyed. Level of Action; For each sample that fails the above standard, an SSURO is issued on the batch from which the sample was collected and a civil penalty Is issued for failure of the batch to meet the efficacy requirements. Failure of a product to destroy Pseudomonus aeruginosa is considered equal to failure of a product to destroy Staphylococcus aureus or Salmonella choleraesius. FIFKA Compliance/Enforcement 5-18 Guidance *a"«*i 1953 ------- Chapter Five Exhibit 5-1 • Disinfectant Product(s) Performance Standard: A product provisionally fails efficacy testing if two or more of the three samples fail to destroy any test organism. Level of Action; Level II testing is initiated for each product that fails the above standard. Level II Testing If a product fails Level I testing, five additional samples represen- ting five different batches are collected for testing at Level II. Sixty carriers are tested for each organism that the product fails to destroy in Level I. • Disinfectant Sample(s) Perfuimaure Standard: A sample is determined to fail efficacy requirements if organisms on 2 or more of the 60 carriers are not destroyed. Level of Action; For each sample that fails the above standards, an SSUE.O is issued on the batch from which the sample was col- lected, and a civil penalty is issued for failure of the batch to meet the efficacy requirements. • Disinfectant Product(s) Performance .Standard: A -product is determined to fail efficacy tfRtlng If three or aore of the five •anples fail to destroy any organism.* Level of Action; Initiation of cancellation proceedings. Bodenticides Both single dose (acute) and multiple dose rodentlcides that make claims for commensal rodents are tested for efficacy. 11 piotluet 'failures are based on the upper bounds of the 95 percent confidence level. Consequently, a sample must fail 5 out of 60 carriers (not 2 out of 60 as in Level I tests) to count as a failure. FIFSA Ompllance/Enforceaent 5-19 Guidance Manual 1983 ------- Chapter Five Exhibit 5-1 • Acute or Single Dose Performance Standard; The minimum standard is 90 percent rodent mortality after eight days of testing for the product to be effective in commensal rodent control* Level of Action; A civil penalty is issued for failure of the batch to meet the above efficacy requirements. • Multiple Dose — Cereal or water baits Performance Standard; The minimum standard is 33 1/3 percent bait acceptance and 90 percent mortality in order for the product to be considered effective in a commensal rodent population. Level of Action; A civil penalty is Issued for failure of the batch to meet the above efficacy requirements. — Paraffin blocks Performance Standard; The minimum standard is 25 percent bait acceptance and 80 percent mortality In order for the product to be considered effective in a commensal rodent population. Level of Action; A civil penalty is Issued for failure of the batch to meet the above efficacy requirements. FIFSA Compliance Eoforceaent 5-20 Guidance Manual 1983 ------- Chapter Five Exhibit 5-2 Criteria for Determining the Gravity of a Use Violation for Purposes of a Certification Action Violation Weighting Activity GRAVITY OF HAKM Pesticide Harm to Human Health Environmental Harm Toxicity—Category I pesticides, restricted use pesticides, or pesticides that are associated vith chronic health effects (mutagenlclty, oncogenicity, teratogenlclty, etc.) Toxicity—Categories II through IV, no known chronic effects Serious or widespread actual harm to human health Serious or widespread potential harm to human health Minor potential or actual harm to human health, neither serious nor widespread Substantial or widespread actual harm to the environment (e.g., crops, water, livestock, wildlife, wilderness, or other sensitive natural areas) Substantial or widespread potential harm to the environment Hiirar potential or actual harm to the environment, neither wide- spread nor substantial FIFEA Compliance/Enfor 5-21 ui 1983 ------- Chapter Five Exhibit 5-2 Violation Weighting Activity (XAVITY OF MISCONDUCT Noncompliance History Culpability 2 0 2 0 More than one prior violation of FIFRA by the applicator One prior violation No prior violations Knowing or willful violation Violation resulting from negligence Violation was neither knowing nor willful and did not result from negligence; good faith efforts made to comply with the law FIFRA CoMpllance/Enf orceaent 5-22 Guidance 1933 ------- Chapter Five Determination of Appropriate Enforcement Response Chapter Contents Page 1 Introduction 5-1 2 Level of Action Policy 5-3 Advertising Letters 5-3 Notices of Detention 5-4 Notices of Warning 5-4 Terminations of Establishment Registrations 5-5 Denials, Suspensions, Modifications, or Revocations of Applicator Certifications 5-6 Recall Requests 5-8 Stop Sale, Use, or Removal Orders 5-10 Civil Administrative Penalties 5-13 Injunctions 5-14 Seizures . .5-15 'Criminal "Proceedings 5-16 Exhibit 5-1: Efficacy Standards and Level of Action Guidance for Disinfectants and Rodenticides 5-18 Exhibit 5-2: Criteria for Determining the Gravity of a Use Violation for Purposes of a Certification Action 5-21 FIFKA Compliance/enxorceaent >-i ------- Chapter Five Contents PIFRA Compliance/Enforcement5-liGuidance Manual 1983 ------- Chapter Five 1 Introduction Once the documentation of a violation Is complete and EPA personnel have determined that an enforcement action Is warranted, EPA must decide upon the appropriate level of action called for by the severity of the viola- tion. There are two categories of action — administrative and judicial. Generally, the Agency uses administrative actions for violations of a lesser nature, for first-time violators,, or to obtain relief on short notice, as in The case of stop sale, use, and .removal orders, The Agency Yeserves judicial actions for use in violations of an especially egregious nature that result In serious harm to human health or the environment, and for willful or repeated violations. Administrative levels of action include the following: • Advertising letters; • Notices of detention under Section 17(c); • Notices of warning under Sections 9(c)(3) and 14(a)(2); » 3ez3BlAa£lonsAf««tafall«fameisr 'registrations under 40 C.F.R.$167.3; • Denials, suspensions, modifications, or revocations of applicator certifications under 40 C.F.R. S171.11; • Recall requests; • Stop sale, use, or removal orders under Section 13(a>; .and -airier "Section 14(a). The criteria for the use of each of the above levels of action are dis- cussed later in this chapter. Specific procedures for preparing and issuing these actions are found in Chapter Six, "Administrative Enforcement Actions: Notices of Violation and Administrative Orders," and Chapter Seven, "Administrative Enforcement ArMnnn * filviJ rcnaltjr JFrocardtTigt • * Eorceaent 5-1 Gn±4w?e ¥~*n*i 1933 ------- Chapter Five Introduction Judicial actions may involve either civil or criminal proceedings. Civil proceedings include: • Injunctions under Section 16(c); and • Seizures under Section 13(b). Criminal proceedings are authorized under Section 14(b). The criteria for the use of judicial actions are also found later in this chapter. Chapter Eight, "Judicial Enforcement: Civil Actions," and Chapter Nine, "Judicial Enforcement: Criminal Actions," discuss procedures for civil and criminal judicial proceedings. In addition, Exhibit 5-1 contains level of action guidance applicable to efficacy standards for hospital or medical use disinfectants and rodenticldes. FURA Compliance/Enforcement 5-2 Guidance Manual 1983 ------- Chapter Five 2 Level of Action Policy Advertising Letters .An advertising letter la a letter Issued by EPA «e notice to a company that collateral literature concerning a product (I.e., literature or advertising that does not accompany the product) bears unaccepted pesticide statements or pesticide or device claims. An advertising letter may be issued by the Agency upon receipt of or knowledge of such literature and without EPA having in its possession an official sample of the pesticide or device accompanied by the literature. An advertising letter should Identify: • The literature; and • The unaccepted statements (if related to a registered product), the pesticide claims (if related to an unregistered pesticide), or the -v device clalas ,------- Chapter Five Level of Action Policy Notices of Detention Section 17 of FIFRA authorizes EPA to refuse admission of a pesticide or device being imported into the United States if EPA determines that such pesticide or device violates any provisions of the Act. This refusal is known as a Notice of Detention and Hearing. Upon receiving a copy of the notice, the Department of the Treasury, through the Customs Service, will refuse delivery to the consignee and will oversee destruction of any pesti- cide or device refused delivery that is not exported by the consignee within 90 days from the date of the notice. However, under the Customs regulations for the enforcement of Section 17(c) of FIFEA, the District Director of Customs may release a shipment to the Importer or the Impor- ter's agent before an EPA inspection of the shipment. Such a release occurs only upon execution of a bond in the amount of the value of the pesticide or device, plus duty. Should the shipment subsequently be refused entry and the importer or agent falls to return the pesticide or device, the bond Is forfeited. A shipment released to the Importer cannot be used or otherwise disposed of until EPA makes a determination of the admlsslbillty of that shipment. Notices of Warning Section 14(a)(2) Notices of Warning Section 14(a)(2) of FIFEA requires EPA to use a notice of warning In re- sponse to the first civil offense committed by a private applicator or other person not covered under Section 14(a)(l). Section 14(a)(l) covers registrants, commercial applicators, "for hire" applicators, wholesalers, dealers, retailers, and other distributors. "For hire" applicators are applicators who apply general use pesticides as a service In controlling pests but who do not deliver any unapplied pesticides. Section 9(c)(3) Notices of Warning Since the Agency Is attempting to concentrate Its pesticides enforcement resources on serious violations and repeat offenders, EPA may also Issue notices of warning under Section 9(c)(3) of FIFRA In response to first-time violations conmltted by those persons covered by Section 14(a)(l), with the following exceptions: • The Agency should pursue a remedy more severe Chan a warning in response to first offenses that result In (1) a real risk to humans or the environment or (2) any actual harm stemming from the viola- tor's failure to exercise due care (i.e., the degree of care a rea- sonably prudent person would exercise in simillar circumstances); and Mpllaneg/BiforeMent; 5^4 " Qifdg"**? Manual ------- Chapter Five Level of Action Policy • The Agency should apply a remedy other than a notice of warning In the case of a violation by a person who has already been placed on notice of the existence of FIFRA or Its requirements. (EPA will consider a person to have been placed on notice If that person has been subject to a formal Inspection by EPA personnel or has Interacted with the Agency by obtaining a product registration, an establishment registration, or any other similar license, permit, or certification.) The Agency, in its discretion, may decide to issue a Section 9(c)(3) warning notice against persons .Included In the latter exception or against a repeat violator whose second violation is an extremely minor one, if EPA enforcement officials believe that justice will be served by employing such a remedy. Termination of Establishment Registration The regulations related to the registration of pesticide-producing estab- lishments (40 C.F.R. S167.3) state that an establishment registration will remain din effect so long as the establishment continues to submit annual pesticides reports. If the establishment falls to submit a report in any year, the Agency may issue either a notice of warning or a civil penalty, based on the provisions of FIFRA Sections 7------- Chapter Five Level of Action Policy strictly technical and are based on the operating procedures of the FIFRA and TSCA Enforcement System (FATES). Termination of establishment regis- tration in such situations should not be confused with termination for cause. Denials, Suspensions, Modifications, or Revocations of Applicator Certifications The regulations relating to the certification of pesticide applicators (40 C.F.R. Part 171) authorize EPA to deny, suspend, modify, or revoke feder- ally issued applicator certifications if the certificate holder violates FIFRA or its regulations. The Agency views an enforcement action affecting certification status as a very strong measure, to be taken only when the "public health, interest or welfare warrants immediate action" [40 C.F.R. S171.11 (f)(5)(i)j* Therefore, EPA will deny, suspend, modify, or revoke a certification only in response to serious violations or against persons with a history of noncompliance. The Agency may take any of these actions if it determines that an applicant for or holder of a certification has: • Been convicted under Section 14(b) of FIFRA; • Been subject to a final order imposing a civil penalty under Section 14(a); • Misused a pesticide; • Made available for use, or used, a registered pesticide classified for restricted use. other than in accordance with Section 3(d); • Refused to keep and maintain records required by 40 C.F.R. Part 171; • Made false or fraudulent records, invoices, or reports; • Failed to comply with any limitations or restrictions on or in a previously issued certificate; or • Violated any other provision of FIFRA or Its regulations. Denial/ Revocations The denial or revocation of a certification not only deprives an applicator of the authority to apply restricted use pesticides but also, as compared to suspension of a certification, forces the applicator to take additional steps to acquire or re-acquire certification. In addition, the Agency will not consider an application to acquire or re-acquire certification for a period of not less than six months following denial or revocation. Thus EPA will deny or revoke a certification only where a violation has resulted ------- Chapter Five Level of Action Policy in a fatality or created an imminent danger of a fatality, where the viola- tor's certification has been suspended as a result of a previous violation, or where a person has made fraudulent records or reports. Suspensions When considering invoking the less severe alternative of suspending a cer- tification, EPA personnel must determine whether it is appropriate to pur- sue a suspension and for how long such suspension should be in effect. These determinations will depend upon the gravity of the violation in question. Suspension (Misuse Violation). In suspending a certification due to an Incident of misuse, EPA will refer to criteria for assessing the gravity of a use violation (see Exhibit 5-2). The gravity of a use violation is a function of: • The risk of harm posed to human health and the environment by the violation; and • The degree of misconduct exhibited by the violator. The Agency will assign weightings, based on the gravity criteria, for each use violation relative to the pesticide involved, the harm to human health and/or to the environment, the history of noncompliance, and the culpabil- ity of the violator. (For purposes of this section of the manual, EPA will not distinguish between commercial and private applicators. Consideration of applicator status is Inherent in the policy in that suspensions have a more substantial Impact on commercial applicators, affecting their primary business activity.) The Agency will use the gravity value thus obtained to decide whether and for how long to suspend a certification, in .accordance -with the following table: Total Gravity Value Enforcement Remedy 4 or below Mo action or Notice of Warning 5 to 8 Suspension of up to 2 months 9 to 12 Suspension of .between 2 And 4 months • 13 ;or rmtoove : ,-.-• Suspension t»f JNtaain 4 *nd 6 wmtbe To determine whether the term of a suspension should be at the higher or lower end of the given ranges, EPA will consider any gravity-related fac- tors not accounted for in the gravity criteria. In addition, EPA will con- sider the degree to uM^h frh* anajvanflfon jrfU )t*m» >.-,mn - cm tfae «ppllca£or* •:<*$&*%?+**?*+ -i*™******* •-^••-••Inl'Mitly- -gf f rettti IT a suspension, such as those who apply restricted use pesticides Infrequently, should receive longer suspensions than applicators whose day-to-day FIFRA Compliance/Baxoreeaent 5-7 Guidance Mp**"a1 1983 ------- Chapter Five Level of Action Policy business activities would be severely disrupted by the loss of their certifications. Suspensions should generally be pursued against individual applicators in lieu of a Section 14(a) civil administrative penalty. This, however, does not preclude EPA from issuing both a suspension as well as issuing a warning letter or from assessing a civil penalty against the employer of the applicator In addition to suspending the certification of the applica- tor. Suspension (Recordkeeping Violation). EPA may also suspend certifications of commercial applicators who violate restricted use pesticides record- keeping requirements [see 40 C.F.R. f171.11(c)(7); 40 C.F.R.$171.ll(f)(1) (111)]. These violations do not lend themselves to analysis utilizing gravity of harm criteria. Consequently, EPA will suspend the certifica- tions of persons who fall to maintain restricted use pesticides records based solely on gravity of misconduct considerations. The Agency will • assess suspensions of up to two months for the second Independent violation resulting from the failure to maintain restricted use pesticides records. For each additional violation, two months may be added to the term of the suspension up to a limit of six months. In cases where the violation Involved keeping fraudulent records (i.e., where the violator Intentionally concealed or misrepresented the true circumstances and the extent of the use of restricted use pesticides), EPA may revoke the violator's certifica- tion in response to the initial infraction. If EPA decides to suspend certification, It must notify the applicator of the time period during which the suspension will be In effect. In order for the suspension to function as a deterrent, the suspension should take effect during the time when the applicator is most likely to be applying restricted use pesticides. • Recall Requests No explicit authority exists in FIFRA for the recall of products. The effectiveness of a recall action, therefore, is contingent on the cooperation of the Involved company. Recalls should be Initiated by EPA in all cases where available Information Indicates that the product is either potentially hazardous when used as directed or Ineffective for the purposes claimed. The Agency should consider a recall of a product when, among other things, its use as directed is likely to result in: • Injury to the user or handler of the product; • Injury to domestic animals, fish, wildlife, or plant life; FIFRA Compliance/Enforcement: 5^8 Guidance Manual 1983 ------- Chapter Five Level of Action Policy • Physical or economic injury because of ineffectiveness or due to the presence of actionable residues; or • Identifiable adverse effect on the environment. EPA personnel must view a request for recall as a serious and extraordinary matter and must make a request for recall of a product only In those cases where the evidence clearly supports such action. The initial decision that a product should be withdrawn from the market will be based on Information In the sample file including laboratory analyses, staff evaluations and opinions, and such other information as may be available and relevant. All Information supporting a recall decision.must be included in the official file. Formal and Informal Recalls There are two types of recalls—formal and informal. Formal recalls are used for more serious problems when it is essential that EPA regional per- sonnel follow up the recall with a visit to the company. Formal recall Involves "EPA monitoring, ^detailed reporting by the company Involved, and notification to State officials. This type of recall is normally accom- panied by another enforcement action, generally a civil penalty. The Agency uses informal recalls in cases where a recall is necessary but the level of potential hazard is not great or when it is unlikely that sig- nificant amounts of the defective product remain in the marketplace. An Informal recall is conducted entirely by the company Involved with no moni- toring by EPA or State officials. Level of Recall Determination level of recall Is the point In the distribution chain from which the product Is to be recalled. The determination of that point is based on the potential hazard, use pattern, and distribution pattern of the product. The following recall levels should be considered: • Wholesale or First Point of Distribution. This will normally include all Informal recalls and those formal recalls In which the product distribution is limited and consequently the .potential .low. • Retail Level. This will be the normal level for most formal re- calls. • User Level. This level will be requested only In cases in which there Is a known serious hazard to human health or the environment. F1AA liovpliance/Enforceaent 5=9 ' Guidance Manual 1983 ------- Chapter Five Level of Action Policy Scope of the Recall EPA must also consider the scope of the recall (i.e., the amount of the product that the recall will cover). In the case of labeling violations, the recall should include all of the product bearing the unacceptable labeling. For chemical violations, the recall should include all of the product bearing the same batch code(s) as the sample(s) found In viola- tion. If the product is uncoded, EPA will determine the scope of the recall after contacting the responsible company. After reviewing the firm's manufacturing and shipping records, EPA personnel should be able to determine a range of manufacturing dates to Include In the recall. The recall of a defective product by the manufacturer or distributor is the most effective and efficient means of removing such a product from the mar- ket. However, since it Is strictly voluntary, the success of the recall program depends on the industry's knowledge that: • EPA will make a recall request only in those cases where there is a likelihood of physical or economic Injury from the use of a product according to label directions; • The Agency will use all legal means available to it to support or supplement any recall request, including stop sale, use, or removal orders, seizures, and civil penalties; and • State officials will cooperate with the Agency in the removal of such products. Stop Sale, Use, or Removal Orders A stop sale, use, or removal order (SSURO) should be Issued by EPA if the violation is of an ongoing nature and threatens to cause serious or widespread harm. This remedy Is not designed to prevent future violations, but rather is intended to limit the amount of harm that might result from a violation. In order to preserve the hearing rights of the recipient of an SSURO, EPA should supplement the order with a civil penalty assessment. An SSURO Is among the most expedient and effective remedies available to EPA In its efforts to prevent Illegal sale, distribution, and use of pesti- cides. Its advantages over other actions (such as seizures) are that: • It may be Issued without prior adjudication of the violatlve char- acter of the product (i.e., EPA may issue an SSURO simply when it has reason to believe that the product is in violation of the Act); • It is easier to prepare and issue than a seizure; FIFRA CoKTl"1 *•"'•*/1tnfnr''*~"nt' *-ln Guidance ------- Chapter Five Level of Action Policy • It can be written so as to include future amounts of the product that may come into the custody of the person on whom the SSURO is served; and • It can be easily adapted to particular circumstances. Criteria for Use The language of Section 13(a) confers broad authority upon EPA to issue SSDROs. The Agency may issue an SSURO when any one of three situations exists: • If, upon inspection or testing, EPA believes a product is In viola- tion of the Act; • If EPA believes that a product has been or is Intended to be dis- tributed or sold in violation of the Act; or • If EPA has cancelled or suspended the registration of a product. An SSURO is ordinarily Issued by EPA without prior notice to the person served. Because an order is Issued without notice, the actual or potential danger to human health or the environment posed by the vlolatlve product or situation must be both serious and imminent* In addition, the danger must require such urgent relief that there is no time to seek other remedies or that other administrative remedies would be inappropriate. Accordingly, EPA officials must observe stringent guidelines In determining whether issuance of an SSURO is appropriate, as outlined below. Mandatory Issuance of an SSURO. The Agency must issue an SSURO against persons who own, control, or have custody of pesticides In the following categories: • Pesticides whose registrations have been cancelled or suspended by EPA, except cases In which the Agency has permitted the use of existing stocks, or where continued marketing presents no human health or environmental hazard; • Pesticides for which there is reason to believe present a potential hazard to man or the environment because: -They are not registered, or are so grossly overf emulated or adulterated, as to present a serious health hazard, or - They are packaged in improper or damaged containers, or are so Inadequately labeled, as to Bake safe or effective use unlikely or impossible; FIFIA Gmpllance/Enlorceaent 5-11 guidance Manual 1983 ------- Chapter Five Level of Action Policy • Pesticides or devices with labeling that is materially misleading or fraudulent and, if observed by a user, is likely to cause a life-endangering health hazard or serious adverse environmental condition. (A pesticide lacking a restricted use label is an especially serious labeling violation.) This provision includes labeling for products that: - Are ineffective for the purposes claimed, - Are so chemically deficient as to affect deleteriously the pro- duct's efficacy, as determined by laboratory test results, or - Bear false or misleading safety claims; • Pesticides or hazardous devices* that are in violation of the Act and are the subject of a voluntary recall, but which the respon- sible party refuses to remove, is recalcitrant in removing, or is unable to remove from channels of trade; and • Pesticides or hazardous devices that are in violation of the Act and for which a civil penalty has been Issued but which have not been brought into compliance. Discretionary Issuance of an SSURO. EPA may exercise its discretion in Issuing an SSURO in cases where a product either is in violation of the Act or is Intended to be distributed or sold in violation of the Act, and the gravity of the violation is less than that required for issuance of a mandatory SSURO. In addition to an analysis of the relative severity of the violation (or lack thereof), the following factors should be considered: • Whether the violation is another in a series of violations by the producer or distributor. In cases of recidivism, of uncorrected violations previously brought to the individual's attention, or of repeated negligent conduct, an SSURO may be appropriate where other enforcement remedies have failed to bring about corrective action or where it is deemed necessary to prevent continued marketing of the violative product; • Whether the violation is easily corrected* If it appears that the individual is cooperative and can easily remedy the violation, an SSURO may be unnecessary; and * A hazardous device is one presenting a direct threat to human health or the environment by its use (e.g., a water treatment device whose labeling makes false, misleading, or fraudulent claims to purify raw well water or other untreated water supplies). For nonhazardous devices (e.g., an electromagnetic rodent repelling device) that are misbranded, Agency policy is to complete civil penalty proceedings before issuing an SSURO. See December 19, 1979 Memorandum: "Enforcement Actions Concerning Nonhazardous Pesticide Devices." FIFRA Compliance/Enforcement 5-12 Guidance Manual 1983 ------- Chapter Five Level of Action Policy • Who has custody of the product. An SSURO may be more appropriate, and a violation more Immediately cured, If the vlolatlve product IB found at the producer level rather than at the retail level. In all other cases, EPA should consider an alternative enforcement remedy available under FLFRA. Use of SSURO for Minor Violations While £PA will usually reserve the use of an SSDRO to relatively serious violations, the need to Issue an SSURO may arise in certain cases Involving minor violations. For example, in the face of continued and repeated minor violations, or when several minor violations appear together on a label, EPA may decide to issue an SSURO to ensure that the product will be distributed only in compliance with the Act. Alternative Approaches Even in cases"where the existence of a serious violation would justify the issuance of an SSURO, the Agency may consider the use of alternative approaches to achieve compliance. For example, certain pesticide labeling violations can be rectified through a voluntary recall by the manufacturer, and this may be the most expeditious way to prevent any harm to human health or the environment. Thus, in certain cases that could legitimately call for the Issuance of an SSURO, particularly those concerned with labeling violations, EPA might first consider contacting the appropriate responsible party and negotiating a voluntary recall. Civil A civil penalty, as authorized by Section I4(a) of FIFEA, is the remedy of choice for most violations. A civil penalty should be proposed where the violation presents (a real but not an extreme and unreasonable) risk to humans or the environment; is likely to be an isolated occurrence; was apparently committed as a result of ordinary negligence, Inadvertence, or Involves a first offense under the Act by any registrant, commer- cial applicator, "for hire" applicator, wholesaler, dealer, re- taller, or other distributor (no prior warning is required by FIFEA for violators in this category); or Involves a private applicator or other person, other £han any party ^specified Ja'titf JClxst•;,*a*!^fgM*rj••••*•* ***Xi****Tfnd -a jrlor TOnr^rg or ^clt«tlt«"------- Chapter Five Level of Action Policy Injunctions Section 16(c) of FIFRA gives EPA the authority to initiate injunctive actions before district courts.* Because an injunction is an extraordinary form of relief, the Agency's arguments must be clear and compelling. In initiating a permanent injunction action, EPA must indicate to the court that: • The Agency's administrative or other judicial enforcement remedies would be inadequate either at restraining the violation or at pre- venting unreasonable risk to human health or the environment; • The Agency has, in fact, already diligently exercised all appro- priate administrative remedies (such as SSUROs and civil penal- ties), yet the violation continues unabated; and • Irreparable injury, loss, or damage will result if relief is not granted. In the case of a preliminary Injunction or temporary restraining order, the Agency must additionally demonstrate that: • immediate and irreparable injury, loss, or damage will result if relief is not granted; and • There is a likelihood of success at trial, based on facts before the court. Under FIFRA, there are a number of specific circumstances that may justify injunctive relief. These include but are not limited to: • The violation of a Section 6 suspension order; • The violation of an SSURO where a civil penalty or criminal prose- cution would not provide a timely or effective remedy to deter fur- ther violations; • There is continued production, shipment, sale, or use of an unreg- istered pesticide after the Agency has taken civil or criminal action; and These actions may consist of permanent injunctions, preliminary injunc- tions, or temporary restraining orders. These types of injunctions are discussed in more detail in Section 4 of Chapter Eight. FIFEA Compliance/Enforcement 3-14 Guidance Manual 1983 ------- Chapter Five Level of Action Policy The Agency has exercised an enforcement remedy and a person con- tinues to make available for use a restricted use pesticide other than in accordance with FIFRA Section 3(d), or continues to use a pesticide in a manner inconsistent with its labeling or In a manner contrary to an experimental use permit. Seizures Section 13(b) of FIFRA gives EPA the authority to initiate in rem condemna- tion proceedings in district court. Once a court grants the Agency's request for authority to conduct a seizure, FIFRA Section 9(b) authorizes duly designated Agency employees to obtain and execute warrants for the purpose of seizing any pesticide or device that is in violation of the Act. Since seizures are judicial actions directed against violatlve products rather than ..against • Relieve ±hat a person, if issued ------- Chapter Five Level of Action Policy Criminal Proceedings Section 14(b) of FIFRA provides EPA with the authority to proceed with criminal sanctions against violators of the Act, subject to the following distinctions: • A registrant, commercial applicator, wholesaler, dealer, retailer, or other distributor who knowingly violates the Act is subject, upon conviction, to a fine of not more than $25,000, or Imprison- ment for not more than one year, or both. • A private applicator or other person not Included above who know- ingly violates the Act Is subject, upon conviction, to a fine of not more than$1,000, or Imprisonment for not more than 30 days, or both. The Agency may initiate criminal proceedings In every case In which EPA can meet the stringent requirements of evidence and proof leading to a convic- tion. However, Agency policy, as well as pragmatic resource considera- tions, argues against the use of criminal sanctions In any but the most serious Instances of environmental misconduct, as determined by the nature of the violation, the history of compliance on the part of the responsible person, or the seriousness of the environmental consequences. Considerations There are a number of specific factors that the Agency must carefully con- sider before proceeding with a criminal prosecution. (Chapter Nine, "Judicial Enforcement: Criminal Actions," addresses these considerations in much greater detail.) Knowledge. The Agency must determine that the violator In question know- ingly violated the statute. That Is, there must be evidence of intent in the commission of the vlolative act, rather than it merely being the result of accident or mistake. Seriousness. Criminal actions should be considered for the most serious types of environmental misconduct. This consideration will be judged by reviewing the extent of environmental harm or human health hazard that resulted from, or was threatened by, the prohibited conduct. Factors ouch as the duration of the -conduct and the toxic!ty of the pollutants are considered. Also of significance In assessing the seriousness of the conduct Is the Impact—real or potential—upon EPA's regulatory function. Deterrence. The Agency must consider the Importance of and need for deter- rence of criminal conduct, either on the part of a specific person, or on the part of the larger community. In the case of a serious and willful violation, the Interests of deterrence may well best be served by the Imposition of criminal sanctions. Compliance/Enforcement 5-16 Guidance Manual 1983 ------- Chapter Five _ Level of Action Policy Compliance History. The compliance history of the person who Is the sub- ject of possible criminal proceedings will enter Into the Agency's deliber- ations. While a history of noncompllance is not requisite for pursuing criminal sanctions, certainly criminal prosecution becomes more appropriate when a history of noncompllance exists. Simultaneous Actions. The Agency may consider whether there is a need for criminal enforcement proceedings contemporaneous with a civil or adminis- trative enforcement action, or whether one type of action alone will serve the situation in question. While simultaneous proceedings are permissible, and there may be very compelling reasons for pursuing both, the legal and practical difficulties inherent in so doing, argue-against such an approach except in the most extraordinary circumstances. Use of Criminal Proceedings The Agency has identified a number of specific situations that may be considered of such a serious nature that criminal prosecution is particularly appropriate. To J.ist these situations, however, should not be •viewed .as precluding criminal prosecution in circumstances not Included below: * • Failure to report information on the unreasonable adverse effects of a registered pesticide; • Falsification of records; • Violation of an order suspending or cancelling a product registration; • Violation of an SSURO; <• Unlawful uses of pesticides; and • Illegal distribution of unregistered pesticides. FIFSA Ompllance/Baforceaent 5-17 Guidance Manual 1983 ------- Chapter Five Efficacy Standards and Level of Action Guidance for Disinfectants and Rodentlcldes Efficacy standards have been developed and are being utilized by the Agency for hospital or medical use disinfectant products and rodenti- cldes. The efficacy standards and level of action guidance for these two types of pectlcldes are summarized below. However, for the com- plete disinfectants laboratory testing procedures and level of action guidance, refer to December 17, 1980 Memorandum: "Regulation of Public Health Belated Disinfectant Products." Additionally, for both disin- fectants and rodentlcides, consult the civil penalty matrix in Appendix 6 for the appropriate civil penalty calculations. Disinfectants Only hospital or medical use products that make claims for Salmonella choleraesius, Staphylococcus aureus, or Pseudomonus aeruglnosa* are tested. Level I Testing In Level I testing, 60 carriers must be tested against each of the above organisms with each of three samples, representing three different batches. This amounts to 180 carriers per sample; a total of 540 carriers. • Disinfectant Sample(s) Performance Standard; A sample is determined to fail efficacy testing if organisms on 2 or more of the 60 carriers are not destroyed. Level of Action; For each sample that fails the above standard, an SSURO is issued on the batch from which the sample was collected and a civil penalty is Issued for failure of the batch to meet the efficacy requirements. Failure of a product to destroy Pseudomonus aeruglnosa is considered equal to failure of a product to destroy Staphylococcus aureus or Salmonella choleraesius. FURA Ompllance/Enforceaent 5-18 Guidance Manual 1983 ------- Chapter Five ^ Exhibit 5-1 • Disinfectant Product(s) Performance Standard; A product provisionally fails efficacy testing if two or more of the three samples fall to destroy any test organism. Level of Action; Level II testing is Initiated for each product that fails the above standard. Level II Testing If a product fails Level I testing, five additional samples represen- ting five different batches are collected for testing at Level II. Sixty carriers are tested for each organism that the product falls to destroy in Level I. • Disinfectant Sample(s) yerfDTmance 'Standard: A sample is determined to fall efficacy requirements If organisms on 2 or more of the 60 carriers are not destroyed* Level of Action; For each sample that fails the above standards, an SSURO is issued on the batch from which the sample was col- lected, and a civil penalty is issued for failure of the batch to meet the efficacy requirements. • Disinfectant Product(s) Performance .Standards A product la determined to fall efficacy . .testing .If .three .or acre of the five «ampl«s fall to destroy any organism.* Level of Action; Initiation of cancellation proceedings. Bodentlcldeg Both single dose (acute) and multiple dose rodentlcldes that sake claims for commensal rodents are tested for efficacy. ljev«l TI product failures are "based on the upper bounds of the 95 percent confidence level. Consequently, a sample must fail 5 out of 60 carriers (not 2 out of 60 as In Level I tests) to count as a failure. FIFRA Coapllance/Enforceaent 5-19 Guidance MMMI 1983 ------- Chapter Five __ Exhibit 5-1 • Acute or Single Dose Performance Standard: The minimum standard is 90 percent rodent mortality after eight days of testing for the product to be effective in commensal rodent control. Level of Action; A civil penalty is issued for failure of the batch to meet the above efficacy requirements. • Multiple Dose — Cereal or water baits Performance Standard; The minimum standard is 33 1/3 percent bait acceptance and 90 percent mortality in order for the product to be considered effective In a commensal rodent population. Level of Action; A civil penalty is issued for failure of the batch to meet the above efficacy requirements. — Paraffin blocks Performance Standard; The minimum standard is 25 percent bait acceptance and 80 percent mortality in order for the product to be considered effective in a commensal rodent population. Level of Action; A civil penalty is Issued for failure of the batch to meet the above efficacy requirements. FIFRA Compliance Enforcement 5-20 Guidance Manual 1983 ------- Chapter Five Exhibit 5-2 Criteria for Determining the Gravity of a Use Violation for Purposes of a Certification Action Violation Weighting Activity GRAVITY OF HARM Pesticide Harm to Human Health Environmental Harm • :J -Toxicity—Category I pesticides, restricted use pesticides, or pesticides that are associated with chronic health effects (mutagenlcity, oncogen!city, teratogenlclty, etc.) Toxicity—Categories II through IV, no Jmown chronic effects Serious or widespread actual harm to human health Serious or widespread potential harm to human health Minor potential or actual harm to Yrrrman K»a1 »h widespread Substantial or widespread actual harm to the environment (e.g., crops, water, livestock, wildlife, or -other sensitive ) Substantial or widespread potential harm to the environment to uvli uument , neither wide- spread nor substantial v\ffA Compliance/Bnfor 5-21 Guidance 1983 ------- Chapter Five Exhibit 5-2 Violation Weighting Activity GRAVITY OF MISCONDUCT Noncompliance History Culpability 2 0 2 0 More than one prior violation of FIFEA by the applicator One prior violation No prior violations Knowing or willful violation Violation resulting from negligence Violation was neither knowing nor willful and did not result from negligence; good faith efforts made to comply with the law FIFRA Compliance/Enforcement 5-22 Guidance 1983 ------- Chapter Six Administrative Enforcement Actions: Notices of Violation and Administrative Orders Chapter Contents Page 1 Introduction 6-1 2 Administrative Enforcement Procedures 6-3 Advertising Letters 6-3 Notices of Detention 6-4 Notices of Warning 6-4 Terminations of Establishment Registrations 6-5 Denials, Suspensions, Modifications, or Revocations of Applicator Certifications 6-6 Recall Requests 6-8 Stop Sale, Use, or Removal Orders 6-10 Exhibit 6-1: Model Advertising Letter 6-14 Exhibit 6-2: Model Notice of Detention and Hearing 6-15 Exhibit 6-3: Model Release Notice 6-16 Exhibit 6-4: Model Notice of Refusal of Admission 6-17 Exhibit 6-5: Model Notice of Warning 6-18 Exhibit 6-6: Model Notice of Intent To Terminate Establishment Registration 6-19 Exhibit 6-7: Model Notice of Termination of Establishment Registration 6-20 Exhibit 6-8: Proposal for Recall Form 6-21 Exhibit 6-9: Model Formal Recall Request In Connection with Suspension or Cancellation 6-22 Exhibit 6-10: Model Formal Recall Request in Connection with Sample Collections 6-23 Exhibit 6-11: Model Informal Recall Request 6-24 Exhibit 6-12: Model Stop Sale, Use, or Removal Order 6-25 Exhibit 6-13: Model Termination of Stop Sale, Use or Removal Order 6-26 'IFRA Compliance/Enforcement 6-1 gaf.da"** Manual ------- Chapter Six Contents FIFBA umpllance/Enforcement 6-ii Guidance M"""»T 1983 ------- Chapter Six 1 Introduction This chapter outlines the specific procedures that EPA should follow In Initiating and processing administrative enforcement actions, once the Agency has determined that an administrative enforcement response Is appro- priate for a detected violation. These actions Include the following: • Advertising letters; • Notices of detention under Section 17(c); • Notices of warning under Sections 9(c)(3) and 14(a)(2); • Terminations of establishment registrations under 40 C.F.R. 5167.3; • Denials, suspensions, modifications, or revocations of applicator certifications under 40 C.F.R. Sl7l.ll; • Recall requests; and • Stop sale, use, or removal orders under Section 13(a). One or more examples of each type of action, In Its proper format, appear as exhibits at the end of this chapter. Civil administrative penalties are not covered In this chapter. However, civil administrative penalty procedures are outlined in detail in Chapter Seven, "Administrative Enforcement Actions: Civil Penalty Proceedings." Appendix 6, "Penalty Policies," also contains useful procedural information for civil penalty actions. In addition, Chapter Five, "Determination of Appropriate Enforcement Response," discusses the criteria the Agency uses in deciding when and what type of enforcement actions to issue. FIFBA Compliance/Enforcement 6-1 Guidance Manual 1983 ------- Chapter Six .Introduction 6-2 Guidance Manual 1983 ------- Chapter Six 2 Administrative Enforcement Procedures Advertising Letters An advertising letter Is a letter Issued by EPA as notice to a company that collateral literature concerning a pesticide or device bears unaccepted pesticide statements or pesticide or device claims. Since FIFRA does not contain a specific provision for advertising letters, it is not an enforcement action In an official sense. Bather, it indicates Agency concern regarding the statements or claims found in the advertising or literature related to a product and encourages voluntary correction on the part of the responsible party. It does not imply any further enforcement action, although the Agency may take further action if EPA subsequently collects an official sample and finds that the company has not taken corrective steps. Content Requirements An advertising letter consists of three parts (see Exhibit 6-1): • An identification of the collateral literature; • An identification of the unaccepted statements (if related to a registered pesticide), the pesticide claims (if related to an unregistered pesticide), or the device claims (if related to a device); and • A request to the recipient to respond to EPA with an indication of how the company will make changes or corrections in the literature, typically by deleting, qualifying, or justifying the statements or claims. Service The Agency should issue an advertising letter by certified mall, return receipt requested. FIFBA Cwpliance/Enforcement S—J Guidance bSsamal 1985 ------- Chapter Six Administrative Enforcement Procedures Notices of Detention Section 17 of FIFRA authorizes EPA to refuse admission of a pesticide or device being Imported into the United States if EPA determines that such product violates any provisions of the Act. This refusal is known as a Notice of Detention and Hearing (see Exhibit 6-2)* Procedures When, on the basis of available Information or actual inspection, the Agency determines that an Imported shipment should be detained, EPA should prepare and issue to the importer a Notice of Detention and Hearing. The Agency should also send a copy of the notice to the District Director of Customs at the port of entry. For this reason, the EPA Regional Offices should have on file the names and addresses of the District Directors, plus the customs compliance officers or commodity specialists who deal with EPA for each port of entry within the .Region's Jurisdiction* Release Notice. If, through examination of the product or other means, EPA can determine that the product has been brought into compliance with FIFRA, EPA should issue a Release Notice (see Exhibit 6-3) to the importer with a copy to the District Director of Customs of the port of entry. Refusal of Admission. If the product has not been brought into compliance with the Act, EPA should issue a Notice of Refusal of Admission (see Exhibit 6-4) to the Importer with a copy to the District Director of Customs at the port of entry. The District Director will refuse entry of the product and will cause .destruction of the product if the Importer does not export it within 90 days from the date of such Ifotlce of ..Refusal of Release of Product Under Bond. If the District Director of Customs has already released the product to the importer under bond, the District Director will take action to enforce the terms of the bond. If the District Director finds it necessary to request forfeiture of an importer's bond because the importer did not hold the shipment Intact as required, the District Director may ask EPA to determine the amount to be levied against the Importer's bond. The tfitmry f^f™lit A*f»r^in* f*nm*+4+m y^tvy-.M-np fn ±he aMMsrlty of the yinlatAom and the ^aaMSPM «fay the product was not -available for redelivery . Notices of Warning Section 14(a>C2) of JglEA J«pilre» gPA .to t»c m wtit» of •warning in response to the first civil offense committed by private applicators or other persons not covered under Section 14(a)(l). The Agency may also issue notices of warning under Section 9(c)(3) of FIFRA in response to P1FRA Coapliance/EiLforceaent 6^4 Guidance Manual 1983 ------- Chapter Six Administrative Enforcement Procedures first-time violations committed by any registrant, commercial applicator, wholesaler, dealer, retailer, or other distributor, "for-hire" applicator— that is, those persons covered by Section 14(a)(l)—if, in EPA's judgment, justice will be served by employing that remedy rather than a civil penalty or other action. Content Requirements A notice of warning is a letter to the responsible party and consists of three parts (see Exhibit 6-5): • Identification of the violative product or action; • Identification, citation, and explanation of the violation; and • A closing paragraph indicating the expected response from the recipient, If any. If the Agency does not receive the requested response from the recipient, indicating what action that party has taken to correct the violation, the Agency will not initiate any further enforcement action. However, EPA may wish to schedule a follow-up Inspection to determine whether the violation has been corrected. If EPA finds, upon reinspection, that the responsible party has not corrected the violation, the Agency should proceed with a civil penalty. Service The Agency should issue a notice of warning by certified mail, return receipt requested. Terminations of Establishment Registrations The regulations related to the registration of pesticide-producing establishments, at 40 C.F.R. 5167.3, state that the registration of an establishment will remain In effect so long as the establishment continues to submit annual pesticides reports. If the establishment falls to submit a report In any year, EPA may issue either a notice of warning or a civil penalty, based on the provisions of FIFRA Sections 7(c)(l) and 12(a)(2)(L). A notice of warning Is the appropriate action for a newly registered establishment that falls to submit its initial pesticides report. The Agency should initiate a civil penalty In response to the failure to file a pesticides report on the part of an establishment that previously filed at least one annual report and is thus on notice as to its continuing responsibility to submit annual reports. corceaent 6-5 ------- Chapter Six Af*»-tn-f«trative Enforcement Procedures Procedures If the establishment does not submit a report within 20 days after the date of receipt of a notice of warning or civil penalty, EPA should issue a Notice of Intent to Terminate Establishment Registration (see Exhibit 6-6). This notice informs the establishment of the violation of failure to report and warns the establishment of Impending termination of registration if EPA does not receive the delinquent report In an additional 20 days. The notice also reminds the establishment of the potential violation of producing pesticides, active Ingredients, or devices in an unregistered establishment. Termination of Registration. If the Agency does not receive the delinquent report in the 20-day period following its issuance of a Notice of Intent to Terminate Establishment Registration, EPA should then issue a Notice of Termination of Establishment Registration (see Exhibit 6-7). This notice revokes the registration, effective as of the date of Issuance, and contains a warning against producing pesticides, active ingredients, or devices in an unregistered establishment,, as veil as Instructions for ^frtMnyfrng T+*v*t***m**** of *••%****»**««. The Agency should send the notice "by certified mail, return receipt requested. The Agency may proceed with both the Notice of Intent To Terminate Establishment Registration and the Notice of Termination of Establishment Registration Independently of any other action, such as a civil penalty. Reinstatement of Registration. It is Agency policy to reinstate terminated establishment registration, provided that the company submits all reports due and submits a completed Application for Registration of Pesticide- Producing Establishment (EPA Form 3540-8). The Agency will issue the same establishment registration number to the re-registered establishment. The submission of delinquent reports and of an fj*r1'*'"'f"t'>" fnr..p*i-*M4*tim»nf registration, ;3awBv«r, does not preclude the Agency -from proceeding with * penalty action for failure to submit reports. Denials, Suspensions, Modifications, or Revocations of Applicator Certifications aha.^gagn1«rt«Mv-«»-1^H^v-tox«^^ (40 C.T.TU Part 171) authorize EPA to deny, suspend, modify, or revoke federally Issued applicator certifications If the certificate holder violates FIFRA or Its regulations. The regulations also specify the procedures that EPA must follow in denying, suspending, modifying, or revoking a certification. The Agency jiay suspend any fiarf :or:vll of.'M. - y*» * * t^t^y+^op jLavedifttel £or «>Aevxiag /upon det«rn±nlTig that such action is warranted by "the public health, interest, or welfare" [40 C.F.R. fl71.11(f)(5)(l)]. The Agency may deny issuance of a certificate, or modify or revoke an existing certificate, after providing opportunity for a hearing . FIFRA Compliance/Enforcement" §=5 ' 6uidanc« ------- Chapter Six A^«*"*strative Enforcement Procedures Content Requirements Suspension. If EPA decides to suspend a certification, the Agency must notify the certificate holder of: • The grounds for suspension; • The time period during which the suspension will be effective; and • The Agency's intent to revoke or modify the certificate, as appropriate. A notice to revoke or modify may be issued before or at the same time as the notice to suspend. Denial. If the Agency decides to deny the issuance of a certificate to an applicant, or to modify or revoke a previously issued certificate, It must notify the applicant or certificate holder of: • The grounds for such action; • The time period for which such action will be effective and whether the action will be permanent or temporary; • The conditions, if any, under which the person may become certified or recertified; and • Any additional conditions that EPA may Impose. Hearings At the same time, the Agency must also provide the affected person with the opportunity to request a hearing prior to final Agency action on its proposed denial, revocation, or modification. If the person requests such a hearing, EPA must: • Notify the person of the assertions and facts upon which EPA has based Its decision; • Provide the person opportunity to offer written statements, explanations, comments, and arguments relevant to the proposed action; • Provide the person such other procedural opportunities as may be appropriate to ensure a fair and impartial hearing; and • Appoint an EPA attorney, who has no prior connection with the case at hand, as Presiding Officer to conduct the hearing. The Presiding Officer must promptly conduct a hearing. He or she must consider all evidence, explanations, comments, and arguments submitted by both EPA and the affected person and render a decision and order as soon as possible. Such an order is a final Agency decision, subject to judicial review under FIFRA Section 16. PURA Compliance/Baf or cement 2F7 Guidance Manual 1SJB3 ------- Chapter Six Administrative Enforcement Procedures Considerations As noted above, a suspension, because of the extraordinary circumstances implicit in such an action, becomes effective Immediately, and there is no opportunity for review or appeal. However, since a notice to suspend must include or be preceded by a notice to deny, modify, or revoke a certificate, and since a denial, modification, or revocation must include opportunity to request a hearing prior to final Agency action, the affected person retains the right to a hearing. Recall Requests A recall is a request from the Agency to the party responsible for a .violative product to voluntarily withdraw that product from the marketplace. Because FIFRA contains no explicit authority for recalls, the effectiveness of such an action is dependent on the cooperation of the Involved company. The Headquarters PTSCMS and the Registration Division of the Office of Pesticide Programs jointly will make the determination for a formal recall involving a product whose registration EPA has suspended or cancelled. In all other cases, the Region in which a violative product was produced will make the decision to Initiate a recall and whether the recall should be formal or informal. A Region initiating a recall must consult with the Headquarters PTSCMS. Consultation with the Registration Division is also required for all formal recalls. .Procedures When consulting with PTSCMS, the initiating Region should forward a Proposal for Recall Form (see Exhibit 6-8) to PTSCMS by telecopier, along with adequate documentation by which to judge the recall decision. If PTSCMS agrees with a recall (along with the Registration Division, if necessary), the Region would receive Initial notification of the decision by telephone. PTSCMS would then return the Proposal for Recall Form by mall, signed by a PTSCMS official (and a Registration Division official, if object .to to recall , *the form would be returned with the reasons for the objection noted in writing. The Agency should request a recall in the form of a letter to the responsible company. It is Important that recall letters be as complete and Informative as possible. Whenever possible, the letter should clearly express the expected level and scope .of -the xecall. Compliance/Enxorceaent 6-8 <_riHan«»» HI?""*" ------- Chapter Six Administrative Enforcement Procedures Content Requirements A formal recall request in connection with a suspension or cancellation should contain the following (see Exhibit 6-9): • The reason for recall; • The identity of the product to be recalled; • The procedures to be followed; and • The EPA personnel who will supervise the action and who may be contacted by the company in regard to the recall. A formal recall request for any other reason should include (see Exhibit 6-10): .• The reason for the recall, citing the violation; • The shipment or producer establishment involved; • The identity of the product to be recalled, including batch codes if the recall involves an ineffective or misformulated product; '• The procedures to be followed; and • The EPA personnel who will supervise the recall and whom the company may contact in regard to the recall. An Informal recall usually accompanies another enforcement action, such as a civil penalty or a stop sale, use, or removal order (SSURO). The informal recall request should contain (see Exhibit 6-11): • The reason for recall, citing the violation; and • The identity of the product to be recalled, including batch codes if the recall involves an ineffective or misformulated product. The Headquarters PTSCMS should prepare all formal recall letters Involving product registration suspension or cancellation. The Regional Offices should prepare all other types of recall letters. In either case, the Initiating office should mall the recall letter by certified mail, return receipt requested. The initiating office should also distribute copies of the recall letter to the other Regional Offices and to the Headquarters PTSCMS for their use in monitoring the recall. FIFRA CbapUanee/Enforceaent 6-9 Guidance Manual 1983 ------- Chapter Six Administrative Enforceaent Procedures An SSURO may apply prospectively to amounts of the named product that may come Into the person's ownership, control, or custody* Procedures | Service. The Agency should serve a written or printed SSURO to the person . who owns, controls, or has custody of the vlolatlve product. An authorized I Agency employee should serve the original copy (i.e., deliver by hand) and acknowledge the service by signing the order in the space provided and 1 entering his or her title and the time and date of service. Where it Is highly Impractical to deliver an SSURO by hand, EPA may instead serve it by certified mall, return receipt requested. The person served should acknowledge receipt of the order by signing the order in the space provided, entering his or her title, and returning a copy to the person serving the order (if it is served in person) or to the issuing EPA office (if served by certified mall). A failure or refusal on the part of the person served to acknowledge receipt does not Invalidate either the order ; or its service, but the EPA official or .office .serving -the order should ±n the file «uch a failure or refusal. Marking. Wherever practical, a sticker should be -placed on the material covered by the order to indicate to all persons coming in contact with the product that it is under such an order. The sticker must be placed so as not to obscure or destroy the product labeling when removed. If the order is served in person, the EPA official making the service should post the sticker. If the order Is served by mall, the order should instruct the person served to clearly identify to his or her employees the product that is under order. The issuing EPA office may also wish to include with the order a sticker for the receiving person to post with the product or an illustrative example of how the product covered by the order should be ^identified. Monitoring the SSURO As long as an SSURO remains in effect, the issuing EPA office should monitor periodically the order to determine that its terms are being observed. Similarly, EPA should check for compliance with the order before terminating it. Documentation of such monitoring should be noted in the 'official file. Disposing of the Product Since any product under an SSURO cannot be disposed of In any manner contrary to the terms of the order, the Agency must determine the proper disposition for I>11«hrrt fin wntf\ ame -tarsm. ;m«Mwr1*m of the following: • Obtaining product registration; FIFRA Ompllance/Enforceaent 6-11 Guidance Manual 1983 ------- Chapter Six Administrative Enforcement Procedures • Reconditioning by relabeling, reformulation, and/or repackaging so as to bring into compliance with FIFRA; • Relabeling so as to remove from the purview of FIFRA; • Designating for institutional uses that do not constitute use violations; • Detoxifying; • Distributing for sale and use for lawfully registered uses; • Relabeling or repackaging for export In confonuance with Sections 3, 17, and 19 of FIFRA; • Obtaining for distribution and use a valid experimental use permit; or • Destroying. Terminating the SSURO When EPA determines that the responsible party has taken appropriate steps to accomplish proper disposition, EPA should record the method of disposition and the amount of the pesticide or device involved and issue a letter terminating the SSURO (see Exhibit 6-13). In cases of disposition requiring movement of the product under the SSURO, EPA must first amend the order In writing to allow such movement. Therefore, EPA should terminate an order only after completion of the disposition. If EPA terminates an SSURO on the basis of the responsible person's attestations that the product has been brought Into compliance with FIFRA but without benefit of an actual Inspection by the Agency, EPA should draft the letter terminating the order so that such termination is conditional upon the product being In compliance with the Act. The Agency might otherwise find Itself in a situation In which the SSURO Is terminated although, through mistake or fraud, the product Is still not In compliance with FIFRA. Violations of the SSURO Any violation of an SSURO Is a violation of FIFRA Section 12(a)(2)(I) and Is considered a very serious violation warranting either a civil or criminal penalty. The Agency may proceed directly to a civil or criminal penalty, as appropriate, if the violator is a "registrant, commercial applicator, wholesaler, dealer, retailer, or other distributor." In those instances in which a private applicator or other person not Included under Section 14(a)(l) violates an SSURO, Sections 14(a)(2) or 14(b)(2) govern the violation. Since Section 14(a)(2) requires a written warning for first-time offenders, EPA should consider exercising either a Section I4(b)(2) criminal prosecution for private applicators or other persons FIFRA GoBpliance/Enforceaent 6-12 Guidance Manual 1983 ------- Chapter Slat Administrative Enforcement Procedures covered by Section 14(a)(2) who violate an SSURO, or Issue a notice of warning and, should the violation of the SSURO continue, proceed with a civil penalty. In addition to taking a civil penalty or criminal action In response to the violation of an SSURO, EPA should also institute Section 13(b) seizure proceedings to prevent any continued violations of the order* Should both a seizure and a Section 14 penalty be ineffective in preventing violation of an SSURO, the Agency may seek injunctive relief under Section 16(c). umpii«nce/isa±orce»ent o-lj Qufdff"r» M?tllMl 1983 ------- Chapter Six Exhibit 6-1 Model Advertising Letter (Company name) (Address) Subject: Gentlemen: In connection with the enforcement of the Federal Insecticide, Fungicide, and Rodenticide Act, as-amended, 7 U.S.C. 5136, the Environmental Protection Agency has obtained copies of (title or description of collateral literature). This literature makes statements regarding* the product, (name of product), such as (quote improper or unacceptable statements or claims). These statements identify the product as a pesticide within the meaning of the Act. Refer to Section 3 of the Act, a copy of which is enclosed. The use of these statements in connection with the distribution and sale of the product would constitute a violation of the Act. Therefore, you should delete these statements or submit an application for the registration of the product. Please inform us of the action you will take in this matter. Sincerely yours, (Signature, name, and title) Enclosure Note: This is a general example only and does not represent the only appropriate format. Additional or different paragraphs may be Included as necessary to fully explain or describe the unaccepted statements or claims and the response that the Agency expects from the responsible party. FIFEA GDBpllance/Bnforceaent 6*14 Guidance Manual 1983 ------- Chapter Six Exhibit 6-2 Model lotice of Detention and (Company name) (Address) Subjec t: (Sample number) Gentlemen: In connection with the enforcement of the Federal Insecticide, Fungicide, and Rodentlcide Act, as amended, 7 U.S.C. §136, the Environmental Protection Agency has examined samples or other evidence concerning the shipment described below, and has determined that said shipment is in violation of the Act. Tou should continue to hold the merchandise pending A final, decision as to whether it shall be admit- ted or refused admission. Pursuant to Section 17(c) of the Act, the Agency hereby affords you an opportunity to offer such explanation as you wish for the Agency's consideration. Tou should file your answer, signed by you or your attorney, with this office within twenty (20) days after your receipt of this notice. Should you desire to present your views orally, in addition to filing a written reply, you should so advise us in your answer in order that we may set a date for such presentation, which would be held in this office. Sample No(s). Date of Importation Consignee Shipper/Manufacturer Entry No. -Product Uame(s) Date Port of Entry produc£(*) ^failed to comply "with the provisions of the Act in that (describe violation). A copy of the Act is enclosed for your reference. Sincerely yours, ure, name, and title) Enclosure FIFBA Ompllance/Enforceaent 6-15 Guidance Mm*"n1 1983 ------- Chapter Six Exhibit 6-3 Model Release Bo tice (Company name) (Address! """"""" Subject: (Sample number) Gentlemen: In connection with the enforcement of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended, 7 U.S.C. $136, the Environmental Protection Agency has completed its consideration of the following shipment. Based on examination of samples or other evidence, the Agency concludes that, pursuant to Section 17(c) of the Act, you need not further detain the merchandise. Sample No(s). Product Name(s) Date of Importation Consignee Shipper/Manufacturer Entry No. Date Port of Entry This notice does not constitute assurance that the merchandise involved complies with all provisions of the Act and in no way precludes fur- ther action should the Agency determine that the merchandise is viola- tive. Sincerely yours, .(Signature, name, and title) FXFBA Compliance/Enforcement 6-16 Guidance Manual 1983 ------- Chapter Six Exhibit 6-4 Model Botlce of Refusal of Admission (Company name) (Address) Subject: (Sample number) Gentlemen: In connection with the enforcement of the Federal Insecticide, Fungicide, and Rodenticlde Act, as amended, 7 U.S.C.$136, the Environmental Protection Agency has examined samples or other evidence with respect to the following shipment and has granted to you an opportunity for a hearing. Sample No (s). Product Name(s) Date of Importation Consignee Shipper/Manufacturer Entry No. Date Port of Entry It appears that the product(s) is(are) not in compliance with the Act and is(are) subject to refusal of admission due to the following (Described violations) The Agency hereby notifies you that it refused admission of the merchandise. Tou must export this merchandise, under supervision of the Customs Service, within ninety (90) days from the date of this notice or within such additional time as the District Director of Customs specifies. Failure to do so may result in either the jdestruc- ;tion of ^nev?aercaandi»e «• authorized by ±he iAct, or, if the shipment iia« *eeu Teleased "to you under bond, in any action necessary to enforce the terms of said bond. Sincerely yours, :titlc) F37RA CbBpliance/Boforcevent 6-17 Guidance Manual 1983 ------- Chapter Six Exhibit 6-5 Model Notice of Warning (Company name) (Address) SubJect: (Sample number) Gentlemen: In connection with the enforcement of the Federal Insecticide, Fungicide, and Rodentlcide Act, as amended, 7 U.S.C. $136, the Environmental Protection Agency has under consideration a sample of (name of product), which the Agency obtained on (date of inspection). This product had been released for shipment by your producing establishment in (city and state)* The product did not comply with the provisions of the Act in that (describe violations). You should make all necessary corrections to assure yourself that any further marketing of this product is in full compliance with the provisions of the Act. The Agency will Include in the file regarding this matter any additional Information that you wish to submit. Sincerely yours, (Signature, name, and title) Note: This is a general example only and does not represent the only appropriate format. Additional or different paragraphs may be include as necessary to fully explain or describe violations and the response that the Agency expects from the responsible party. FIFXA. Compliance Enforcement 6-18 Guidance Manual 1983 ------- Chapter Six Exhibit 6-6 Model Hotlce of Intent to Terminate Establishment Begistratlon (Company name) (Address) .Subject: (Establishment registration: number) Gentlemen: The Environmental Protection Agency hereby informs you of the Agency's intention to terminate the registration of your establishment, located in (city and state), pursuant to Section 7 of the Federal Insecticide, Fungicide, and Rodentlcide Act, as aaended, 7 D.S.C.$136, and 40 £.£.&. 1167.3. Die Agency Intends to take this action based on your fmllore to submit reports required by Section 7 (c) of the Act and by 40 C.F.R. S 167.5. Tour failure to file the required reports by (due date) has already subjected you to civil or criminal penalties under the Act. Your failure to submit the required reports within twenty (20) days of your receipt of this notice will result in the termination of your establishment registration, effective upon the date of the Agency's issuance of a Notice of Termination of Establishment Registration. Tour submission of the required reports within the twenty (20) day time period shall not affect your liability under the civil and Tou should take all necessary measures to preclude any production at your establishment not in compliance with the Act. Production of pesticides, active ingredients, or devices in an unregistered establishment or in an establishment whose registration has been terminated is an unlawful action subject to the civil and criminal penalty provisions of the Act. . 'Sincerely x-onrs (Signature, name, and title) FIFSA Cbvpllance/Enforceaent 6-19 Guidance Manual 1983 ------- Chapter Six Exhibit 6-7 Model Notice of Termination'of Establishment Registration (Company name) (Address) Subj ect: (Establishment registration number) Gentlemen: The Environmental Protection Agency hereby Informs you that the Agency has terminated the registration of your establishment, located in (city and state), pursuant to Section 7 of the Federal Insecticide, Fungicide, and Rodentlcide Act, as amended, 7 U.S.C. S136 and 40 C.F.R. Si67.3. The Agency has taken this action based on your failure to submit reports required by Section 7(c) of the Act and by 40 C.F.R. S167.5. You may apply for reinstatement of your establishment registration at any time subsequent to the termination of your establishment registration. However, the reinstatement of your establishment registration will be expressly conditional upon the Agency's receipt of your delinquent pesticide report(s) together with an application for establishment registration (EPA Form 3540-8). Tou should take all necessary measures to preclude any production at .your establishment not in compliance with the Act. Production of pesticides, active ingredients, or devices in an unregistered establishment or in an establishment whose registration has been terminated is an unlawful action subject to the civil and criminal penalty provisions of the Act. Sincerely yours, (Signature, name, and title) FZFBA CoBpliance/Enforcesent 6-20 Guidance Manual 1983 ------- Chapter Six Exhibit 6-8 Proposal for Recall Fora [ ] Formal Recall [ ] Informal Recall Region has decided to recall the product (name of product) for the following reasons: (reasons for recall) Xeglon _____ requests that the Compliance Monitoring Staff (and the Registration Division, in the case of formal recalls) review this proposed action, based upon the following evidence, copies of which are attached: [ ] Collection Report [ ] Scientific Review [ j Analytical Reports [ j Other - Specify „[ J Labels Regional Office (Sign and Date) Agreement with this recall action should be indicated with signature and date below. If there is objection to this action, the reason should be specified. Compliance "Monitoring Staff (Sign and Date) Registration Division (Sign and Date) FIFRA Cbapllance/Bnforceaent 6-21 Guidance Manual 1983 ------- Chapter Six Exhibit 6-9 Model Formal Recall Request In Connection with Suspension or Cancellation (Company name) (Address) Sub j ect: (Name of product and registration number) Gentlemen: On (date) the Environmental Protection Agency sent a letter to you notifying you that registration under the Federal Insecticide, Fungicide, and Rodenticide Act, as amended, 7 D.S.C. §136, for (name of product) is (suspended/cancelled)« As set forth in the letter of (suspension/cancellation), the Agency has determined that (general reason for suspension or cancellation). Therefore, the Agency requests that your company take immediate action to withdraw this product from the market. Specifically, the Agency requests: 1. That your company initiate procedures to determine the locations of all quantities of this product and the amount of such product at each location; 2. That the product be returned to your company from all such locations; and 3. That you inform us of (a) all steps your company has taken in connection with the recall of this product, and (b) the completeness of the recall action. The Agency will supervise this action through the office of (name, title, address, and telephone number of supervising EPA official). Mr./Ma. (name) , or a representative of his/her office will contact you on this matter. Thank you for your cooperation. Sincerely yours, (Signature, name, and title) FIFRA Compliance Knforce-ent 6-22 Guidance Manual 1983 ------- Chapter Six Exhibit 6-10 Model Formal Becall Bequest In Connection with Sample Collections (Company name) (Address) Subject: (Sample number) Gentlemen: In connection with the enforcement of the Federal Insecticide, Fungicide, and Rodentlcide Act, as amended, 7 U.S.C. §136, the Environmental Protection Agency has obtained and tested a sample of the product (name of the product). The Agency obtained this sample on (date of inspection) from your producing establishment located In (city and.state). Tests of the product coded (indicate code) showed the product to be (results of tests and their implications for use of the product). In view of the Intended uses of this product, the Agency requests that your company take Immediate action to withdraw this product from the market. Specifically, the Agency requests: 1. That your company initiate procedures to identify the consignees of the product; 2. That your company request that the consignees return -this product \to ------- Chapter Sis Exhibit 6-11 Model Informal Recall Request The Agency requests that you take steps to determine whether any additional amounts of this product remain in channels of trade. If so, the Agency further requests that you remove all such lots of the product, coded (indicate code), from the market. Hote: For an informal recall request, the above paragraph is Inserted into the documents that are prepared in connection with other enforce- ment actions (e.g., civil penalty, stop sale, use, or removal order, etc.). PIFRA Cb»lianee/EnfnrreBW»T?f- (.-•>&. ------- Chapter Six Exhibit 6-12 Model Stop Sale, Use, or Removal Order UNITED STATES ENVIRONMENTAL PROTECTION AGENCY STOP SAT.?., USE, OR REMOVAL ORDER (Date) (Name of persons ordered) Sample No(s) (Name of company) (Address) By the authority vested in me pursuant to Section 13(a) of the Federal Insecticide, Fungicide, and Rodenticide Act, .as amended, 7 D.S.C. f 136k, I hereby order yra^^ the pesticide or device (name of product, batch codes, and other identification). Based upon inspection or tests, the Environmental Protection Agency has reason to believe that the pesticide or device is in violation of the provisions of Section _ of the Act in that the pesticide or device (specify violations), This order shall pertain to all quantities of the above-named pesti- cide or device within the ownership, control, or custody of the above-named person, wherever located. Said pesticide shall not be sold, used, or removed other than in accordance with the provisions «f tils «rder or «>f*nch farther orders as vsy be issued in connection ^pesticide tnr "device. Any person violating the terms or provisions of this order shall be subject to the penalties described in Section 14 of the Act, 7 D.S.C. §1361. (Signature, name, and title) Order served by: (Signature and title of EPA employee, time and data) For Information concerning this Stop Sale, Use, or Removal Order, contact: (Name and title, address and phone number of Regional Office) FIFBA Caap1.<*"»rr/ffinfnri:cariit 6-25 Guidance Manual 1983 ------- Chapter Six Tfrhlblt 6-13 Model Termination of Stop Sale, Use, or Reaoval Order UNITED STATES ENVIRONMENTAL PROTECTION AGENCY TERMINATION OF STOP SALE, USE, OR REMOVAL ORDER (Date) (Name of person ordered) Sample No(s)._ (Name of company) (Address) The Environmental Protection Agency has determined that (state amount) of the pesticide or device named in the Stop Sale, Use, or Removal Order dated (date of order) has been (method of approved disposal; e.g., registered, relabeled, destroyed, etc.) as of (date of disposi- tion). Therefore, the Stop Sale, Use, or Removal Order is terminated concerning the amount of the pesticide or device stated above. Any other amounts of the pesticide or device affected by the order shall remain under the effect of the order until disposed of in the manner described above. (Signature, name, and title) FIRA Co«p11 r*f*/**fy*'ewf*+ 6-26 Qoidance Mammi 1983 ------- Chapter Seven Administrative Enforcement Actions: Civil Penalty Proceedings Chapter Contents Page 1 Introduction 7-1 Mongol Ida ted JLules of Practice (CROP) 7-1 2 Elements of a Violation; Administrative 7-3 3 Complaint Preparation and Filing 7-45 Civil Penalty Complaint Criteria 7-45 Delegated Authority 7-46 FIFRA Penalty Assessment 'Considerations 7-48 Complaint Preparation 7-51 of t"hf CpgipJjfn*' 7—32 Service of the Complaint 7-55 Filing the Complaint 7-56 Exhibit 7-1: Sample Complaint 7-57 Exhibit 7-2: Sample Cover Letter 7-60 Exhibit 7-3: Model Affidavit of Service 7-61 4 Prehearing Stage 7-63 .Intggggnor* «id ^nicog ;Cgri»e 7-63 Agency Files * 7-64 Prohibition of Ex Parte Discussion 7-66 Answer to the Complaint 7-67 Prehearing Motions 7-69 Default Orders 7-71 Settlement 7-73 fig Oooxf erence . 7-74 fotlon -f or 'Accelerated Decisions and Dismissals 7-77 7-1 Guidance Mf"1"*1 1983 ------- Chapter Seven Contents 5 Hearing Stage 7-81 Notice of Hearing and Venue 7-81 Presentation of Evidence 7-81 Preponderance of Evidence 7-82 Default Orders and Accelerated Decisions 7-82 Hearing Rules of Evidence 7-83 Objections and Rulings 7-86 Offers of Proof 7-87 Transcript of Hearing 7-87 Proposed Findings, Conclusions, and Orders 7-88 Motion To Reopen Hearing 7-89 Appeals of Interlocutory Orders or Rulings 7-90 Exhibit 7-4: Sample Default Order 7-92 Exhibit 7-5: Sample Consent Agreement and Final Order 7-95 6 Post-Hearing Stage 7-97 Appeal of Initial Decision 7-97 Final Order 7-99 Notice of Judgment 7-100 Payment of Penalty 7-100 FIFBA Coapliance/E&forceaeat 7-ii Guidance Manual 1983 ------- Chapter Seven 1 Introduction In nost instances, the Regional Office determines those violations that warrant the imposition of an administrative civil penalty. Many violations fall into this category. However, if the violation is sufficiently minor, a notice of warning may be appropriate (see Chapter Six, "Administrative Enforcement Actions: Notices of Warning and Administrative Orders"). Conversely, If «ay be more appropriate (see Chapter Nine , ~ Judicial Enforcement : Criminal Actions"). Chapter Five contains a general discussion of appropriate enforcement responses. This chapter focuses on FIFRA civil penalty actions and the procedures for litigating administratively assessed penalties. Consolidated Rules of Practice She Consolidated Rules ------- Chapter Seven Introduction In order to apply to national actions, the CROP require the following substitutions of Agency officials: Regional National Regional Hearing Clerk Hearing Clerk Regional Administrator Administrator Regional Judicial Judicial Officer Officer Substitutions between regional and national officials may also occur If an official is disqualified pursuant to the CROP. 22.04(4) Certain filing and service requirements specified by the CROP are also altered if the actions are conducted at the national level. For example, the Regional Hearing Clerk must forward a record of the proceeding to the Hearing Clerk when an Initial decision is Issued In a regional proceeding. Such a transfer is unnecessary if the proceeding was conducted at the national level. 22. FIFKA Qwpliance/Enforceaent 7-2 Goldaaee MMM! 1983 ------- Chapter Seven 2 Elements of a Violation: Administrative Under Section 14 of FIFRA, the Agency may issue administrative civil complaints to persons who violate Section 12 of the Act. In order to establish-a prima facie administrative case against a respondent, the Agency must establish, by proper evidence, each element of the violation charged. The following charts list each violation that may occur under FIFRA, the related elements of proof Chat are necessary to bring the Eolation to court, and the means by which the element of proof is established. ?IFRA Coapl 1, mtee/Ettforce»ent 7-3 QHdg^^ tfr""*1 1983 ------- Chapter Seven Elements of a Violation: Administrative Section 12 (a)(l)(A) Any pesticide not registered under Section 3. ELEMENTS OP THE VIOLATION ESTABLISHING THE VIOLATION 1. 2. Respondent (person) distributed, sold, offered for sale, held for sale, shipped, delivered for shipment, or received and (having so received) delivered or offered to deliver a pesticide. Determination that the product Is a pesticide. 3. Determination that the pesticide is not registered. 4. Determination that the continued sale and use of existing stocks is not permitted under S6(a)(l) if the product has been cancelled. Identification of the respon- sible party for suspected violation in commerce. See "Additional Sources of Documen- tation" (Chapter 4). Appropriate regional or Registration Division (RD) personnel review product labeling claims to determine whether the product is a pesticide. See "Further Processing of the ID Jacket-- Enforcement Case Review" (Chapter 4). Appropriate regional or RD personnel determine regis- tration status after a search of their files. See "Further Processing of the ID Jacket—Enforcement Case Review" (Chapter 4). Same as No. 3, above. FIFRA Co»pliance/Enforce*ent 7-4 1983 ------- Chapter Seven Elements of a Violation: Administrative Section 12 (a)(l)(B) Any registered pesticide for which any claims made for it as part of its distribution or sale differed substantially from the claims made in connection with its registration. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION 1. Respondent (person) distributed, sold, offered for sale, held for sale, shipped, delivered for shipment, or received and (having so received) delivered or offered to deliver a pesticide. Pet era-illation that the product is -a registered pesticide. 3. Claims made for a registered pesticide as part of its distribution or sale differ substantially from the claims ^aade -in connection vitii its -registration. Identification of the respon- sible party for suspected violation in commerce. See "Additional Sources of Documen- tation" (Chapter 4). ^Appropriate regional or ED personnel determine registra- tion status after a search of their files. See "Further Processing of the ID Jacket—Enforcement Case Review" (Chapter 4). Compare copy of pesticide label, collected as part of the inspection, with registered label. For significance of claimed label discrepancies, see ~1evel of Action Policy" (Chapter 5) and for the penalty amount, see Appendix 6. FIFRA Compllance/Enforc 7-5 uiance 1983 ------- Chapter Seven ELeaents of a Violation: Administrative Section 12 (a)(l)(C) Any registered pesticide whose composition differed at the time of Its distribution or sale from the composition described In connection with Its registration. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION 1. Respondent (person) distributed, sold, offered for sale, held for sale, shipped, delivered for shipment, or received and (having so received) delivered or offered to deliver a pesticide. Determination that the product Is a registered pesticide. Determination that the composi- tion of a pesticide sold or distributed in commerce differs from the composition under which it is registered. 1. Identification of the respon- sible party for suspected violation in commerce. See "Additional Sources of Documen- tation" (Chapter 4). 2. Appropriate regional or ED personnel determine registra- tion status after a search of their files. See "Further Processing of the ID Jacket—Enforcement Case Review" (Chapter 4). 3. Chemistry tests determine the composition of a pesticide sample picked up in commerce. These tests are compared with registrant's claimed composi- tion for discrepancies. See "Laboratory Test Results" under "Initial Review of the ID Jacket" (Chapter 4). Appropri- ate RD personnel determine the significance of any discrep- ancy* See "Further Processing of the ID Jacket—Enforcement Case Review" (Chapter 4). FIFRA CoBpllance/Enforceaent 7-6 Guidance Jlacual 1983 ------- Chapter Seven EL ts of a Violation: Administrative Section 12 (a)(l)(D) Any pesticide that has not been colored or discolored pursuant to the provisions of Section 25(c)(5). ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION 1. Respondent (person) distributed, sold, offered for sale, held for sale, shipped, delivered for shipment, or received and (having so received) delivered or offered to deliver a pesticide. 2. Determination that the product is ji pesticide. 3. Determination that the pesticide has not been colored or discolored pursuant to the provisions of Section 25 (c)(5). 3. Identification of the respon- sible party for suspected violation in commerce. See "Additional Sources of Documen- tation" (Chapter 4). Appropriate regional or ED personnel review product labeling claims to determine whether the product is a pesticide. See "Further Processing of the ID Jacket—Enforcement Case Beviev" (Chapter 4). Consult 40 C.F.R. $162.13 for requirements Imposed on regis- trants to color or discolor pesticides. FIFKA Ckmpliance/Kiforceaent 7-7 1983 ------- Chapter Seven Elements of a. Violation: Administrative Section 12 (a)(l)(K); 2(q)(l)(A) Any pesticide or device that was misbranded in that the labeling bore a statement, design, or graphic representation that was false or misleading. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION Respondent (person) distri- buted, sold, offered for sale, held for sale, shipped, received and (having so received) delivered or offered to deliver a pesticide or device. Determination that the product Is a pesticide or device. Determination that the pesticide or device was misbranded in that its labeling bore a statement or graphic representation that was false or misleading, I.e.: • A false or misleading statement concerning the composition of the product; • A false or misleading statement concerning the effectiveness of the product as a pesticide or device; • A false or misleading statement concerning the value of the product for purposes other than as a pesticide or a device; • A false or misleading comparison with other pesticides or devices; Identification of the responsible party for suspected violation in commerce. See "Additional Sources of Documentation" (Chapter 4). Appropriate regional or RD personnel review product labeling claims to determine whether the product is a pesticide or device. See "Further Processing of the ID Jacket—Enforcement Case Review" (Chapter 4). Consult 40 C.F.R J162.10(a)(5) for requirements Imposed on products to prevent misbranding. Compare copy of pesticide label collected as a part of Inspection with registered label. If available, RD will review efficacy data for the product. For the signifi- cance of mlsbrandlng, see "Level of Action Policy" (Chapter 5) and for the penalty amount, see Appendix 6. FIFRA Gcmpliance/Enforceaent 7-8 Guidance Manual 1983 ------- Chapter Seven Elements of a Violation ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION • Any statement directly or indirectly implying that the pesticide or device is recommended or endorsed by any agency of the Federal government ; • The name of a pesticide .containing two or acre principal active Ingredients If the name suggests one or more but not all such principal active ingredients, even though the names of the other ingredients are stated elsewhere in the labeling. • A true statement used in such a way as to give a false or misleading impression to the purchaser; • Label disclaimers that negate or detract from labeling statements required under the Act and Implementing regulations; H* -Claiafi *s to the safety of the pesticide or its ingredients, Including statements such as "safe," "nonpoi s onous , " "non- injurious," "harmless," or "nontoxic to humans and pets" with or without such a qualifying phrase as "when £*d"; mad Non-numerical and/or comparative statements on the safety of the product, including but not limited to: ingredients," - "Among the least toxic chemicals known," or - "Pollution approved." F1KKA Compliance/Enforceaent 7-9 Guldi Manual .1983 ------- Chapter Seven Elements of a. Violation: Administrative Sections 12(a)(l)(E); 2(q)(l)(B) Any pesticide or device that was misbranded in that it was contained in package or other container or wrapping which did not conform to the standards established by Section 25(c)(3). ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION Respondent (person) distri- buted, sold, offered for sale, held for sale, shipped, received and (having so received) delivered or offered to deliver a pesticide or device. Determination that the product is a pesticide or device. Determination that the pesti- cide or device has not been properly packaged. Identification of the responsible party for suspected violation In commerce. See "Additional Sources of Documentation" (Chapter 4). Appropriate regional or RD personnel review product labeling claims to determine whether the product is a pesticide or device. See "Further Processing of the ID Jacket—Enforcement Case Review"(Chapter 4). Consult 40 C.F.R. S162.16 for the requirements Imposed on regis- trants to package pesticide products or devices In a manner that prevents injury or Illness. Also see Child-Resistant Pack- aging Guidelines issued by PTSCMS. If determination cannot be made, refer to RD personnel. For the significance of deficiencies, see "Level of Action Policy" (Chapter 5) and for the penalty amount, see Appendix 6. PZFRA QoBpliance/Enf orceaeat 7-10 Guidance Manual 1983 ------- Chapter Seven Elements of a Violation: Administrative Sections 12(a)(l)(E); 2(q)(l)(C) Any pesticide or device that was mlsbranded In that It was an imitation of, or was offered for sale tinder the name of, another pesticide or device. ELEMENTS OP THE VIOLATION ESTABLISHING THE VIOLATION Respondent (person) distri- buted, sold, offered for sale, held for sale, shipped, received and (having so received) delivered or offered to deliver a pesticide or device. Determination that the product Is a pesticide or device. Determination that the pesti- cide or device was mlsbranded that it »as offered for sale cide or device, i.e.: • A manufacturer duplicated the composition of another pesticide and offered it for sale under the name of that pesticide. Identification of the responsible party for suspected violation in commerce. See "Additional Sources of Documentation" (Chapter 4). Appropriate regional or RD personnel review product labeling claims to determine whether the product is a pesticide or device. See "Further Processing of the ID Jacket—Enforcement Case Review" (Chapter 4). Appropriate regional or RD personnel determine that manufacturer of product-is aot "the -producer registered to manufacture that product. See "Scientific Review" under "Further Processing of the ID Jacket—Enforcement Case Review" (Chapter 4). FIFRA Co»pl1ance/Bnforceaeat 7-11 Guidance ***"«"• 1 1983 ------- Chapter Seven Elements of a Violation; Adolnistratlve Sections 12(a)(l)(K); 2(q)(l)(D) Any pesticide or device that was misbranded in that its label did not bear the assigned registration number of the establishment in which it was produced. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION 2. Respondent (person) distri- buted, sold, offered for sale, held for sale, shipped, delivered for shipment, or received and (having so received) delivered or offered to deliver a pesticide or device. Determination that the product Is a pesticide or device. Identification of the responsible party for suspected violation in commerce. See "Additional Sources of Documentation" (Chapter 4). 3. Determination that the label of the pesticide or device, did not bear the assigned registration number of the establishment in which it was produced. Appropriate regional or ED personnel review product labeling claims to determine whether the product is a pesticide or device. See "Further Processing of the ID Jacket—Enforcement Case Review" (Chapter 4). Appropriate regional or PTSCMS personnel review product label- Ing to determine whether the appropriate establishment registration number appears on the label collected during the inspection. Consult 40 C.F.R. f!62.10(e) for requirements. For the significance of the omission, •ee "Level of Action Policy" (Chapter 5) and for the penalty amount, see Appendix 6. FIFKA Gmpliance/Enfor 7-12 1983 ------- Chapter Seven Elements of a Violation: Administrative Sections 12(a)(l)(B); 2(q)(l)(B) Any pesticide or device that was misbranded In that words, statements, or other Information that Is required to appear on the label or labeling was not .prominently placed thereon with such consplcuousness and In such terms as to render It likely to be read and understood by the ordinary Individual under customary conditions of purchase and use. ELEMENTS OF TEE VIOLATION ESTABLISHING THE VIOLATION Respondent (person) distri- buted, sold, offered for sale, held for sale, shipped, delivered for shipment, or received and (having so received) delivered .or offered to.deliver a pesticide or device. Determination that the product is a pesticide or device. 1. Identification of the responsible party for suspected violation in commerce. See "Additional Sources of Documentation'* (Chapter 4). 2. Determination that the label or :iyfr»i^nj "tff "the .pesticide or device does not conform to the format required by the product's regis tration. Appropriate regional or RD per- sonnel review product labeling f>ia-tmti to determine whether the product is a pesticide or device. See "Further Processing of the ID Jacket—Enforcement Case Review" (Chapter 4). Appropriate- regional or JU> per- -'AOQDel review.,product .labeling 'to determine conformance with the label accepted in conjunction with the registration. Consult 40 C.F.R.$162.10(a)(2) for "Prominence and Legibility" requirements. For the signifi- cance of the discrepancies, see "Level *>f ^action »Pollcy~ (Chapter 5)^*nd &>r ^ite •penalty' utotxnt, *ee Appendix 6. FIFRA Coapliance/Bafon 7-13 Guidance 1983 ------- Chapter Seven Eleaents of a Violation: Administrative Sections 12(a)(l)(K); 2(q)(l)(F) Any pesticide or device that was misbranded in that the labeling accom- panying it did not contain the directions for use that are necessary for effecting the purpose for which the product is intended, and if complied with together with any requirements imposed under Section 3(d) of the Act, are adequate to protect human health and the environment. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION Respondent (person) distri- buted, sold, offered for sale, held for sale, shipped, delivered for shipment, or received and (having so received) delivered or offered to deliver a pesticide or device. Determination that the product Is a pesticide or device. Identification of the responsible party for suspected violation in commerce. See "Additional Sources of Documentation" (Chapter 4). 3. Determination that the direc- tions for use did not meet the requirements Imposed for the protection of health and the environment by the Act and Implementing regulations. Appropriate regional or RD per- sonnel review product labeling claims to determine whether the product is a pesticide or device. See "Further Processing of the ID Jacket—Enforcement Case Review" (Chapter 4). Appropriate regional or RD personnel review product labeling to determine whether the label obtained during Inspection con- forms to the label accepted in conjunction with the product's application for registration. Consult 40 C.F.R. S162.10(1) for requirements. For the signifi- cance of the discrepancies, see "Level of Action Policy" (Chapter 5) and for the penalty amount, see Appendix 6. FIFSA Gcmpliance/Bnforeesent 7=14 Guidance 1983 ------- Chapter Seven EL ts of a Violation: Administrative Sections 12(a)(l)(K); 2(q)(l)(6) Any pesticide or device that was misbranded in that the label did not contain a warning or caution statement which is necessary, and if complied with, together with any requirements Imposed under Section 3(d) of the Act, is adequate to protect human health and the environment. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION 1. 2. Respondent (person) distri- buted, sold, offered for sale, held for sale, shipped, received and (having so received) delivered or offered to deliver a pesticide or device. Determination that the product is a pesticide or device. 3. Determination that the. 'warning of the Act and/or Implementing regula- tions. 1. 2. 3. Identification of the responsible party for suspected violation in commerce. See "Additional Sources of Documentation" (Chapter 4). Appropriate regional or RD personnel review product labeling claims to determine whether the product is a pesticide or device. See "Further Processing of the ID Jacket— Enforcement Case Review" (Chapter 4). Appropriate regional or RD j>er- review product ?«tM»]i« to determine whether the label obtained during the Inspection conforms to the label accepted in conjunction with the product's application for registration. Consult 40 C.F.R. f!62.10(b) for requirements. For the signifi- cance of the discrepancies* «ee -Level of Action Policy" (Chapter 5) and for the penalty amount, •ee Appendix 6. 7-15 Guidance Manual 1983 ------- Chapter Seven Elements of a Violation: Administrative Sections 12(a)(l)(B); 2(q)(l)(H) Any nonregistered pesticide intended for export that was misbranded in that the statement, "Not registered for use in the United States," was not prominently placed on the label. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION Respondent (person) distri- buted, sold, offered for sale, held for sale, shipped, delivered for shipment, or received and (having so received) delivered or offered to deliver a pesticide. Determination that the product is a pesticide. Determination that the product is not registered. Determination that the required statement was not prominently placed on the label. Identification of the responsible party for suspected violation in commerce. See "Additional Sources of Documentation" (Chapter 4). Appropriate regional or RD personnel review product labeling claims to determine whether the product is a pesticide. See "Further Processing of the ID Jacket—Enforcement Case Review" (Chapter 4). Appropriate regional or RD personnel determine registration status after a search of their files. See "Further Processing of ID Jacket—Enforcement Case Review" (Chapter 4). Appropriate regional or RD personnel review pesticide label to determine whether the required statement was prominently placed. For the significance of its omission, see "Level of Action Policy" (Chapter 5) and for the penalty amount, see Appendix 6. FZFEA Compliance/Soforceaent 7-16 Guidance Manual 1983 ------- Chapter Seven ELeaents of a Violation: Administrative Sections 12(a)(l)(E); 2(q)(2)(A) Aay pesticide that was misbranded in that the label did not bear an ingredient statement on that part of the immediate container that is presented or displayed under customary conditions of purchase, or on another part of the immediate container, or on the outside container or wrapper, as permitted by the Administrator. ELEMENTS OF THE VIOLATION . ESTABLISHING THE VIOLATION 1. 2. Respondent (person) distri- buted, sold, offered for sale, held for sale, shipped, delivered for shipment, or received and (having so received) delivered or offered to deliver a pesticide. Determination that the product is a pesticide. 3. Determination that the product label bears the ingredient mt In ;the .appropriate except: where i The size or fora of the product container makes it Impracticable to place the statement on the part of the label displayed to purchasers; and "The'Statement 'appears promi- nently in another position as permitted. 1. Identification of the responsible party for suspected violation in commerce. See "Additional Sources of Documentation" (Chapter 4). 2. Appropriate regional or RD per- sonnel review product labeling claims to determine whether the product is a pesticide. See "Further Processing of the ID Jacket—Enforcement Case Review" (Chapter 4). 3. Appropriate regional or RD personnel review the product lahfllug to determine whether ±he label obtained during Inspection conforms to the label accepted in conjunction with the product's application for registration. Consult 40 C.F.R. §162.10(g)(2) for the requirements. For the significance of the discrep- ancies, see "Level of Action Policy' (Chapter 5) and Jor she penalty amount, see Appendix 6. TTF1A Taompllance/EnlorcPacnt 7-17 u 1983 ------- Chapter Seven Elements of a Violation: Administrative Sections 12(a)(l)(E); 2(q)(2)(B) Any pesticide that was mlsbranded in that the labeling did not contain a statement of the use classification under which the product was registered. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION 1. 2. Respondent (person) distributed, sold, offered for sale, held for sale, shipped, delivered for shipment, or received and (having so received) delivered or offered to deliver a pesticide. Determination that the product is a pesticide. 3. Determination that the product label does not bear the re- quired statement of use classification, or does not bear the appropriate state- ment In the proper position or size. 3. Identification of the responsible party for suspected violation in commerce. See "Additional Sources of Documentation" (Chapter 4). Appropriate regional or RD personnel review product labeling claims to determine whether the product is a pesticide. See "Further Processing of the ID Jacket—Enforcement Case Review" (Chapter 4). Appropriate regional or RD personnel review product label to determine whether the label obtained at the inspection conforms to the label accepted in conjunction with the product's registration application. Consult 40 C.F.R. $162.10(j) for the requirements. For the significance of the discrep- ancies, see "Level of Action Policy" (Chapter 5) and for the penalty amount, see Appendix 6. FXFRA Coapliance/Enforceaent 7-18 Guidance Manual 1983 ------- Chapter Seven Elements of a Violation: Administrative Sections 12(a)(l)(E); 2(q)(2)(C) Any pesticide that was misbranded in that there was not affixed to its container, and to the outside container or wrapper of the retail package, if there be one, through which the required information on the immediate container cannot be clearly read, a label bearing the required Information. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION Respondent (person) distri- buted, sold, offered for sale, held for sale, shipped, delivered for shipment, or received and {having so received) delivered or .offered to deliver a pesticide. Determination that the product is a pesticide. 1. 2. 3. Determination that the product label jdoes not bear the following required Information: • The name and address of the producer, registrant, or person for whom the pesticide was produced; • The name, brand,, or pesticide Is sold; • The net weight or measure of the contents, unless an exemption Is granted by the Administrator; and assigned to the pesticide and the use classification. 3. Identification of the responsi- ble party for suspected violation in commerce. See "Additional Sources of Documentation" (Chapter 4). Appropriate regional or RD personnel review product labeling claims to determine whether the product is a pesticide. See "Further Processing of the ID Jacket—Enforcement Case Review" (Chapter A). Appropriate regional or JU> personnel review product ly to determine if the label obtained In the Inspection conforms to the label accepted in conjunction with the product's application for registration. For the significance of the omissions, see "Level of Action Policy" .(Chapter 5} and £or the aee Appendix 6. PIFEA Ckmpliance/Bnforceaent 7-19 Guiance 1983 ------- Chapter Seven Elements of a Violation: Administrative Sections 12(a)(l)(E); 2(q)(2)(D) Any pesticide that was misbranded in that it contained a substance or substances highly toxic to humans and its label failed to bear: • The skull and crossbones; • The word "Poison" in red on a distinctly contrasting background; and • A statement of practical treatment (first aid or otherwise) in case of poisoning. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION Respondent (person) distri- buted, sold, offered for sale, held for sale, shipped, delivered for shipment, or received and (having so received) delivered or offered to deliver a pesticide. Determination that the product is a pesticide. 3. Determination that the product label does not bear the required statements or designs. Identification of the responsi- ble party for suspected violation in commerce. See "Additional Sources of Documentation" (Chapter 4). Appropriate regional or RD per- sonnel review product labeling claims to determine whether the product is a pesticide. See "Further Processing of the ID Jacket—Enforcement Case Review" (Chapter 4). Appropriate regional or RD personnel review the product labeling to determine whether the label obtained during Inspection conforms to the label accepted In conjunction with the product's registration application. Consult 40 C.F.R. Sl62.10(h) for the requirements. For the significance of the omission, see "Level of Action Policy" (Chapter 5) and for the penalty amount, see Appendix 6. FIFRA Compliance/Enfor 7-20 Guidance 1983 ------- Chapter Seven Elements of a Violation: Adainlstratli Sections 12(a)(l)(E); 2(c) Any pesticide that was adulterated in that: • Its strength or purity fell below the professed standard of quality under which It was sold; • Another substance had been substituted wholly or in part for the pesticide; or • A valuable constituent of the pesticide had been wholly or in part abstracted. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION Respondent (person) distri- buted, sold, offered for/sale, held for sale, shipped, delivered for shipment, or received and (having so received) delivered or offered to deliver a pesticide. Determination that the product is a pesticide. 1. »Identification of the responsible .-.»• party for suspected violation in commerce. See "Additional Sources of Documentation" (Chapter 4). 2. 3. Determination that the product was adulterated in a manner described by the Act. 3* Appropriate regional or RD per- sonnel review product labeling claims to determine whether the product Is a pesticide. See "Further Processing o£ the ID ", Jacket— •Enforcement Case J&eviev" (Chapter 4). Appropriate regional or RD per- sonnel review chemistry labora- tory tests to determine whether the product composition conforms to the composition accepted In . conj unrflon v±ch the application >for vXftglatratloii. See "Scientific Review" under "Further Processing of the ID Jacket— Enforcement Case Review" {Chapter 4). For the significance of the adultera- tion, see "Level of Action pt«r 5) «nd for tbe ?enalty eooont, see Appendix 6. FIPBA Ocmpliance/Enfor 7-21 Guidance ------- Chapter Seven Elements of a. Violation: Administrative Section 12(a)(2)(A) A person detached, altered, defaced, or destroyed, in whole or in part, labeling required under the Act. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION 1. Determination that the sampled label had been detached, altered, defaced, or destroyed, in whole or in part. 1. Review documentation of the violation to determine the extent of the violation. See "Other Evidential Documentation*' under "Initial Review of the ID Jacket" and "Labeling Review" under "Further Processing of the ID Jacket—Enforcement Case Review" (Chapter 4). For the significance of the alleged violation, see "Level of Action Policy" (Chapter 5) and for the penalty amount, see Appendix 6. Csapliaace/Soforceaent 7-22 Guidance 1983 ------- Chapter Seven Elements of a Violation: Administrative Section 12(a)(2)(B) A person refused to keep records required by Section 8 or by 40 C.F.R. Part 169. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION 1. Determination, that pesticide or device producer did not maintain the following records: • Records showing: - Product name - EPA registration number number (If applicable) - Batch amounts - Batch identification - Production control records - Complete formula if required Brand names and quantities of pesticides or devices produced . Records of - producer receipts of pesti cides, devices, Active Ingredients used in pro- ducing pesticides. — Brand name/ common or chemical riamo - Name and address of shipper • -"•, ->_JIaae -of 1. Regional personnel review copies of records obtained during Inspection to determine whether the records are maintained. See "Other Evidential Documentation" under "Initial Review of the ID Jacket" (Chapter 4). Consult 40 C.F.R. Part 169 for the require- ments. For the significance of the alleged violation, see "Level of Action Policy" (Chapter 5) and for the penalty amount, see Appendix 6. received - Quantities received Records regarding shipment of pesticides, devices, and active ingredients. chemical name - Name and address of consignee FIFKA CoMpllance/Enf or< 7-23 Guia 1983 ------- Chapter Seven Elements of a Violation; Administrative ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION - Name of originating carrier - Date shipped or delivered for shipment - Quantities shipped or delivered for shipment - Distribution information required for pesticides produced pursuant to an experimental use permit, a special exemption, or a special local need • Inventory records of items produced. - Types - Amounts of pesticides or active ingredients - Quantities of devices • Copies of all domestic advertising of restricted uses. • Copies of all guarantees. • For items Intended solely for export - Copies of foreign pur- chaser's specifications or directions for pro- duction - Copies of labels or labeling - Copies of statement signed by foreign purchaser acknowledging that the Item Is not registered for use and cannot be sold for use In the U.S. (Must be obtained for the first shipment of a particular product to a particular purchaser each year.) FZFRA Gmpliance/Eofori 7-24 Manual 1983 ------- Chapter Seven Elements of a Violation: Administrative ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION • Records on disposal - Method - Dates - Sites - Types of pesticides — Amounts • Secords of tests on humans. The following records of tests on human beings must be maintained for 20 years or sent to EPA after 3 years - Name and address of subject - Test dates — .Test types - Written consent of subject - All information and instructions given to subj ect - Any adverse effects of tests on subjects • Research data records - Test reports sent to EPA . in support of: • Registration • Tolerance petition • All underlying raw data with their inter- pretations and evalua- tions FIFBA QmpH ance/Eofo 7-25 Guidance 1983 ------- Chapter Seven Elements of a Violation: Administrative Section 12(a)(2)(B) A person refused to allow the Inspection of any records or of an estab- lishment pursuant to Section 8 or 9.* ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION 1. Determination that the agent in charge of a FIFRA-regulated establishment did not allow the inspector entry for purposes of conducting an Inspection or examination of records. 1. Review inspector's documentation that he or she was denied entry into the establishment for pur- poses of conducting an Inspection or examination of records. Docu- mentation should include the name and position of the company official who refused entrance or records examination, a summary of the conversation or events, and the date and time of the denial. * In N. Jonas and Company Inc., I.F.&R. Docket No. III-121C (July 27, 1978), an Administrative Law Judge held that, even after the Supreme Court's decision in Marshall v. Barlow's Inc.. 436 U.S. 307 (1978) [see Three Warrants in Chapter Three], the refusal to allow a warrantless inspection of a FIFRA-regulated establishment properly subjected the owner to an administratively assessed civil penalty. FIFKA 7-26 1983 ------- Chapter Seven Eleaents of a Violation: Administrative Section 12(a)(2)(B) A person refused to allow an officer or employee of the Environmental Protection Agency to take a sample of any pesticide pursuant to Section 9. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION 1. Determination that the agent in charge of the establishment did not allow the inspector to take a sample of a pesticide. Review inspector's documentation that he or she was denied the right to take a pesticide sample. Documentation should include the name and position of the company official who disallowed the inspector to take a sample of the pesticide, a summary of .the conversation or events, and the date and time of the denial. FIFRA Ooapliance/Enforceaent 7-27 ui 1983 ------- Chapter Seven Eleaentg of a Violation; Administrative Section 12(a)(2)(C) A person gave a guaranty or undertaking provided for din Section 12(b) that was false In any particular. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION 1. Determination that guaranty of registration and compliance with the Act meet the require- ments of the Act and Imple- menting regulation. 1. Consult 40 C.F.R. S162.12 for regulatory requirements and sample guaranty. Review copies of guaranty obtained during inspection. See "Other Evidential Documentation" under "Initial Review of the ID Jacket' (Chapter 4). For the signifi- cance of the alleged violation, see "Level of Action Policy" (Chapter 5) and for the penalty amount, see Appendix 6. FIF1A Compliance/Enfor 7-28 Guidanc n^i 1983 ------- Chapter Seven Elegants of a Violation: Administrative Section 12(a)(2)(D) A person used to personal advantage or revealed to persons other than those authorized by the Act any confidential information acquired under the Act. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION 1. Determination that confidential information was used for per- sonal advantage. Conduct investigation to determine whether respondent had access to confidential informa- tion and whether such information was revealed to unauthorized per- sonnel for respondent's personal advantage. Investigation should include; • Interviews (affidavits) with the party suspected of releasing the information; • The party(ies) suspected of receiving the confidential information; and • Any other Individual with knowledge of the Incident. •'for .^significance of the alleged disclosure, see "Level of Action Policy" (Chapter 5) and for the penalty amount, see Appendix 6. FIFBA CoBpliance/Biforceaent 7-29 Guidance 1983 ------- Chapter Seven Elements of a Violation: Administrative Section 12(a)(2)(K) A person advertised, in his or her capacity as a registrant, wholesaler, dealer, retailer, or other distributor, a pesticide registered for restricted use without giving the classification assigned under Section 3 of the Act. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION 1. Determination that the product is a pesticide registered for restricted use. 2. Determination that a restricted use pesticide was advertised for sale without its appropriate use classifi- cation. Appropriate regional or RD personnel determine registration status after a search of their files. See "Further Processing of the ID Jacket—Enforcement Case Review" (Chapter 4). Review product advertising to determine whether the use classi- fication is included. For list of restricted use pesticides, see 40 C.F.R. 1162.31. See "Labeling Review" under "Further Processing of the ID Jacket—Enforcement Case Review" (Chapter 4). Appro- priate regional RD personnel determine product classification status. For the significance of the omission, see "Level of Action Policy" (Chapter 5) and for the penalty amount, see Appendix 6. FIFRA Gmpliance/Bnforceaseat 7=30 Guidance Manual 1983 ------- Chapter Seven Elements of a Violation: Adainlstratlve Section 12(a)(2)(F) A person made available for use or used a restricted use pesticide for any purpose other than in accordance with Section 3(d) and any regula- tions thereunder. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION 1. Determination' that the product is a pesticide. 2. Determination that a restricted use pesticide was made available for use or used in a manner not in accordance with the uses allowed for the product's registration. Appropriate regional or RD personnel review product labeling claims to determine whether the product is a pesticide. See "Further Processing of the ID Jacket—Enforcement Case Review" (Chapter 4). Consult 40 C.F.R.$162.31 to determine whether the product contains an active Ingredient that requires a restricted use classification. Review inspec- tor's report to determine whether dealer sold restricted use pesti- cide to inappropriate, person or, if appropriate whether pesticide was Improperly used. Review product label to determine use classification. See "Labeling Bevlew" under "Further 'Processing •of the ID Jacket—Enforcement Case Review" (Chapter 4). For the significance of the alleged violation, see "Level of Action Policy" (Chapter 5) and for the penalty amount, see Appendix 6. FIFRA Co*pliance/Enfori 7-31 Guidance Mrniirf'1 1983 ------- Chapter Seven of a Violation; Administrative Section 12(a)(2)(G) A person used a registered pesticide in a manner Inconsistent with its labeling. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION 1. Determination that the product is a registered pesticide* 2. Determination that the product was used in a manner inconsis- tent with its labeling. Regional personnel ensure that product is registered through regional files or RD review. Review accepted label to deter- mine acceptable uses. See "Labeling Review" under "Further Processing of the ID Jacket- Enforcement Case Review" (Chapter 4). Review documentation to determine whether the actions of the respondent (use of the pesticide) were inconsistent with the product's label. For the significance of the alleged violation, see "Level of Action Policy" (Chapter 5) and for the penalty amount, see Appendix 6. FIFRA Cbmpliance/Knfor 7-32 Guidance Manoal 1983 ------- Chapter Seven Elements of a Violation: Administrative Section 12(a)(2)(H) A person used a pesticide that was under an experimental use permit contrary to the provisions of the permit. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION 1* Determination that pesticide Is under an experimental use permit. 2. Determination that use of the pesticide violated the terms of the permit. The permit will specify the following: • Duration of the permit; • Limitations and uses; • Additions; • Records maintenance requirements; • Labeling requirements; and • Reporting requirements. 1. Appropriate RD personnel verify that pesticide is under a permit. Consult permit issued by RD and 40 C.F.R. Part 172 for terms and conditions of permit. Compare with inspection documentation to determine nature of alleged violation. See ""Other Evidential Documentation" under "Initial Review of the ID Jacket" (Chapter 4). For the significance of the alleged violation, see "Level of Action Policy" (Chapter 5) and for the penalty amount, see Appendix 6. TIFBA Compllance/Enforceaent 7-33 u 1983 ------- Chapter Seven Elements of a Violation: Administrative Section 12(a)(2)(I) A person violated an order issued under Section 13. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION 1. Determination that the person who owns, controls, or has custody of a pesticide or device has violated the terms of a stop sale, use, or removal order (SSURO) in that any person having received the SSURO may not sell, use, or remove the pesticide or device 1. Consult the order to determine the terms and conditions of the order. Verify that the order has not been vacated but is still valid. Review Inspection docu- mentation to determine whether the pesticide or device was distributed in commerce. See "Additional Sources of Documentation" (Chapter 4). FIFRA Gcmpllance/Biforceaent 7-34 Guidance *«««"• t 1983 ------- Chapter Seven Elements of a Violation: Adolnlstratlve Section 12(a)(2)(J) A person violated a suspension order Issued under Section 6. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION Determination that:the product has had its registration suspended by order of the Admlnistrator. 2. Respondent (person) distri- buted, sold, offered for sale, held for sale, shipped, . received and .(having so received) delivered or offered to deliver a pesticide in violation of the suspension order. 3. Determination as to whether existing stocks of the product may be distributed in commerce. 1. 2. Appropriate PTSCMS and/or RD personnel advise regional staff of order. (Notice of Suspension published in Federal Register; also on file with RD.) Identification of the responsible party for suspected violation in commerce. See "Additional Sources of Documentation" (Chapter 4). 3. Consult order and PTSCMS policy guidance on case of existing stocks, remaining uses, and time frames for use. For the significance of the alleged violation, see "Level of Action Policy" (Chapter 3) Aid lor the penalty amount, see Appendix 6. FXFRA Goapllance/Eaforceaent 7-35 Guidance Manual 1983 ------- Chapter Seven Elenents of a. Violation: Adieiiilstrative Section 12(a)(2)(K) A person violated cancellation of registration issued under Section 6. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION Determination that the regis- tration of a pesticide has been cancelled. Respondent (person) distri- buted, sold, offered for sale, held for sale, shipped, received and (having so received) delivered or offered to deliver a pesticide product whose registration has been cancelled. Determination as to whether existing stocks of the product may be distributed in commerce. 1. 2. Appropriate PTSCMS and/or RD personnel advise regional staff of product registration cancella- tion. (Published in the Federal Register.) Identification of the responsible party for suspected violation in commerce. See "Additional Sources of Documentation" (Chapter 4). 3. Consult order to determine appro- priate terms and conditions. Check to see if there is any PTSCMS policy guidance on use of existing stocks and time frames for use. For the significance of the alleged violations, see "Level of Action Policy" (Chapter 5) and for the penalty amount, see Appendix 6. FIFRA Co«pliance/Knforceaent 7-36 Guidance Manual 19R3 ------- Chapter Seven Elements of a Violation: Administrative Sections 12(a)(2)(L); 7(a) A person violated Section 7 by falling to register his or her producing establishments. ELEMENTS OP THE VIOLATION ESTABLISHING THE VIOLATION Determination that a pesticide, active ingredient of a pesti- cide, or device was produced (see definition, Section 2(v) of the Act). Determination that the producer of a pesticide, active ingredi- ent, or device subject to the Act has failed to register his or her production establishment. Appropriate regional or RD personnel review product labeling claims to determine whether the product is a pesticide, active ingredient, or device. See "Further Processing of the ID Jacket—Enforcement Case Review" (Chapter 4). Appropriate regional or PTSCMS personnel determine establishment registration status. For the significance of the alleged violation, see "Level of Action Policy" (Chapter 5) and for the penalty amount, see Appendix 6. FIFBA Cbapliance/Bnfor* 7-37 Guidance 1983 ------- Chapter Seven El ts of a. Violation: Administrative Sections 12(a)(2)(L); 7(c)(l) A person violated Section 7 by falling to provide, in either an annual or Initial report, the types and amounts of pesticides or devices he or she Is currently producing, has produced during the past year, or has distri- buted during the past year. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION 1. Determination that producer has failed to submit the required information or failed to submit the Information in a timely manner. Appropriate regional or PTSCMS personnel determine if report was submitted, and if so, review initial or annual report to determine whether the required Information is included and has been filed in a timely manner. Consult 40 C.F.R. 5167.5 for requirements. For the significance of the violation, see "Level of Action Policy" (Chapter 5) and for the penalty amount, see Appendix 6. FIFBA Coapllance/Enforceaent 7-38 Guidance ------- Chapter Seven Elements of a Violation: Administrative Sections 12)(a)(2)(L); 7(c)(2) A person violated Section 7 by falling to provide the names and addresses of recipients of pesticides or devices produced at his or her registered establishment pursuant to the Administrator's request for purposes of issuing a stop sale, use, or removal order pursuant to Section 13. ELEMENTS OF THE VIOLATION 'ESTABLISHING THE VIOLATION 1. Determination that the re- quired information will not be supplied by the producer or is not maintained* 1. Review the request for the infor- mation to determine adequacy of notice. For the significance of the alleged violation, see "Level of Action Policy" (Chapter 5) and for the penalty amount, see Appendix 6. FIFRA Gcmpllance/Enfor 7-39 Guidance 1983 ------- Chapter Seven Elements of a Violation; .Administrative Sections 12(a)(2)(M); 14(a) Any person who knowingly falsified all or part of any: • Application for registration (40 C.F.R. Part 162); • Application for an experimental use permit (40 C.F.R. Part 172); • Information submitted under Section 7 (40 C.F.R. Part 167); • Information marked as confidential and submitted under any provision of the Act; • Records required to be maintained by Section 8 (40 C.F.R. Part 169); • Records, reports, or invoices required by 40 C.F.R. Sl71.11(c)(7); or • Reports required to be filed by the Act. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION 1. Determination that required information has been falsified. 1. Review the data submitted to meet regulatory requirements. Compare with records obtained during the Inspection of the facility to determine whether discrepancies exist. For the significance of the violation, see "Level of Action Policy" (Chapter 5) and for the penalty amount, see Appendix 6. FIFRA Compliance/Enforcement 7-40 Guidance Manual 1983 ------- Chapter Seven El ts of a Violation; Administrative Section 12(a)(2)(H) person who failed, in his or her capacity as a registrant, wholesaler, dealer, retailer, or other distributor, to file reports required by the Act. ELEMENTS,.OF -T™ VIOLATION ESTABLISHING THE VIOLATION 1. Determination of person's status and failure to file required report. the 1. Consult applicable regulation to determine reporting requirements. For the significance of the vio- lation, see "Level of Action Policy" (Chapter 5) and for the penalty amount, see Appendix 6. FIFRA 7-41 Guidance Manual 1983 ------- Chapter Seven EL ts of a Violation: Administrative Section 12(a)(2)(0) Any person who added a substance to, or took a substance from, a pesti- cide in a manner that may defeat the purpose of the Act. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION 1. Determination that the product is a pesticide. 2. Determination that a person altered the composition of a pesticide in order to defeat the purpose of the Act. Appropriate regional or RD per- sonnel review product labeling claims to determine whether the product is a pesticide. See "Further Processing of the ID Jacket—Enforcement Case Review" (Chapter 4). Appropriate regional or RD personnel review laboratory tests to determine whether the pesticide has been altered. See "Scientific Review" under "Initial Review of the ID Jacket" (Chapter 4) and "Laboratory Test Results" under "Further Processing of the ID Jacket— Enforcement Case Review" (Chapter 4). For the significance of the alleged violation, see "Level of Action Policy" (Chapter 5) and for the penalty amount, see Appendix 6. IXFEA Compliance/Enforcewent 7-42 Manual 1983 ------- Chapter Seven El' ts of a Violation: Administrative Section 12(a)(P) Any person who used a pesticide in tests on human beings in violation of conditions specified by the Act. ELEMENTS OF THE VIOLATION ESTABLISHING THE VIOLATION 1. Determination that the test subject was not fully Informed of: • The nature and purpose of the test; and • Any foreseeable physical and /mental ^*»ai »h -f^Tiao— quences. 2. Determination that the test subject did not freely volunteer to participate In the test. 1. Conduct Investigation, then interview test subject. Review testing agreement to determine the degree of disclosure made to the test subject concerning the risks of the test. 2. Interview test subject* Review scientific review of the test to verify nature and purpose of test. For the significance of the alleged violation, see "Level of Action Policy" (Chapter 5) and for the penalty amount, see Appendix 6. FIFHA Compliance/Enfo: 7-43 ui 1983 ------- Chapter Seven Elements of a Violation; uDapjuLonce/fioxorceaent 7—44 r^i-t^^^ ifamuii 1953 ------- Chapter Seven 3 Complaint Preparation and Filing Civil Penalty Complaint Criteria As was previously discussed in .Chapter Five, a civil penalty action is warranted when the "violation presents a real (but not an extreme and unreasonable) risk to humans or the environment; is likely to be an Isolated occurrence; is apparently the result of ordinary negligence, inadvertence, or mistake; and either: • Involves a first offense under the Act by any registrant, commercial applicator, "for-hire" applicator, wholesaler, dealer, retailer, or other distributor (no prior warning is required by the Act); or • Involves a private applicator or other person (other than any party specified above), who has received a prior warning or citation for a :'vlolatlon :of the~ Act. (The. 'prior MBI iritig ox cfl-t8t"icT Bay shave been for the same or a different FIFRA violation.) Issuance of a complaint initiates a FIFRA Section 14(a) administrative penalty action.* Involvement of Multiple Respondents in a Single Violation 2ntqaan£ly~,. the distribution of ;pe»ticldg» or devices In commerce will involve more than one party before the product is ultimately purchased for use. These multiple-party relationships are known as "distribution chains." Some examples of distribution chains Include: • A distributor who is also the registrant of a pesticide and the company that produces the pesticide for this distributor/ * The complaint also serves to satisfy the notice and opportunity to be heard requirement for those actions subject to Section 9(c)(l) of FIFRA. FIFBA Gbmpllance/Bnforcement 7-45 Guidance Manual 1983 ------- Chapter Seven Complaint Preparation and Filing • A producer who holds a registration for a pesticide and a retailer who sells the producer/registrant's pesticide. Under certain circumstances, more than one party in a distribution chain may be legally responsible for the same product violation. Pesticide enforcement officials may cite multiple respondents in administrative cases for an identical violation where it is determined that: • The distributor/registrant and/or producer has no mechanism and has made no effort to determine the reliability of its supplier or packager; • The violative product bears the name of a registered distributor even when no physical contribution was made to a processing or packaging error and there was no knowledge of the violation; or • The violative product bears the name of a distributor who is not the distributor/registrant but whose name provides a basis for consumer reliance. Nonregistered retailers (functioning as "mere conduits'* standing next to the ultimate consumer in the chain of distribution) may, at the complainant's discretion, be spared a civil penalty action in favor of a Section 9(c)(3) notice of warning or an enforcement correspondence if: • The violative product does not bear the retailer's name; or • The violative product bears the retailer's name but the name does not provide the basis for consumer reliance. A producer who is not a registrant but who functions as an agent of the registrant, and whose liability is based solely on the legal relation with the registrant may, at the complainant's discretion be similarly treated. In the case of a single violation involving multiple respondents from multiple Regions, designation of regional jurisdiction over the cases or consolidation of cases thus arising will be determined Jointly by the Involved Regions and Headquarters PTSCMS on a case-by-case basis. Delegated Authority Regional Administrator The Regional Administrator is to exercise all powers and duties as prescribed or delegated under the Act and the CROP. In addition, the 7—Afi ------- Chapter Seven Complaint Preparation and Filing Regional Administrator* has been delegated the authority to: • Issue administrative complaints; • Evaluate the appropriateness of civil penalties; and • Negotiate and sign consent agreements memorializing settlements between the Agency and respondent prior to the alleged violator's filing of an answer or failure to file an answer to a complaint. , The Regional Administrator, however, must consult with the Regional Counsel's office before exercising any of the above authorities. In addition, the Regional Administrator must consult (verbally or in writing) with Headquarters PTSQiS In the following instances: - Routine misuse cases (verbal) , - Exceptional misuse cases of first Impression or of unusual national Importance (written), and of more -than 40 percent of .the .penalty ^originally proposed (written) . In every proceeding, the Regional Administrator will rule on all motions filed or made before an answer to the complaint is filed. 22.16(c) Regional Judicial Officer A Regional Administrator may delegate all or part of his or her authority to act in a given proceeding to a Regional Judicial Officer. Any such delegation is to be performed In accordance with the CROP. A- flfgf ••MI T"^M >*'*al Qff'lTmr~ if^y ••*|TH>rc'l>y- r^ny • anthffT"? **y ri^'^Fflt'pd to him o her by the Regional Administrator, or the Regional Judicial Officer may refer any case or motion to the Regional Administrator when such referral is appropriate. 22.04(b)(3) * The Assistant Administrator for Pesticides and Toxic Substances may also exercise these authorities In multi-regional cases or cases of national significance. However, he or she must consult In advance with the Associate Administrator for OLEC or his or her designee and must notify any affected Regional Administrators or their designees when exercising Division "Director level. 1983 ------- Chapter Seven Complaint Preparation and Filing Presiding Officer The Presiding Officer is to conduct a fair and impartial proceeding, ensure that the facts are fully elicited, adjudicate all issues, and avoid delay. The Presiding Officer has the authority, under 22.04(c), to: • Conduct administrative hearings under these rules of practice; • Rule upon motions, requests, and offers of proof; dispose of procedural requests; and issue all necessary orders; • Administer oaths and affirmations and take affidavits; • Examine witnesses and receive documentary or other evidence; • For good cause, upon motion by a party or sua sponte (i.e., upon his own motion), order a party or an officer or agent thereof to produce testimony, documents, or other nonprivileged evidence and, failing the production thereof without good cause being shown, draw adverse Inferences against that party; • Admit or exclude evidence; • Hear and decide questions of facts, law, or discretion; • Require parties to attend conferences for the settlement or simplification of the Issues, or the expedition of the proceedings; and • Do all other acts and take all measures necessary for the maintenance of order and for the efficient, fair, and Impartial adjudication of Issues arising In proceedings governed by the CROP* FIFRA Penalty Assessment Considerations Factors for Determining Penalty Amount Section 14(a)(4) of FIFRA requires that the Agency consider the following factors In determining the initial penalty amount. Information impacting on this determination may be obtained from financial reports (e.g., Dun and Bradstreet), corporate reports, and reports filed with other government agencies such as the Securities and Exchange Commission. • The Size of the Business of the Person Charged. As applied to violators subject to Section I4(a)(l) of the Act and "for hire" applicators under Section 14(a)(2), size of business should be interpreted to Include total business revenues from total business operations of the business entity to which that product in violation is attributable. 7—48 Guidance pfr11***' 1983 ------- Chapter Seven Complaint Preparation and Filing Where a subsidiary company is validly separable as an entity discrete from its parent, it should be considered alone. Where pesticide production is a constituent part of a total business operation involving numerous nonpesticide products, size of business shall be based on total revenues. This determination should be based on acceptable accounting procedures. The proportion of the pesticide's component to the total diversified activities of the respondent, profit versus loss, etc., may be considered for purposes of mitigation, but should not be .entered at the outset when initial penalty assessment is determined based on consideration of the size of the business. The Effect on the Defendant's Ability To Continue in Business. Should there be evidence at the outset that the proposed penalty will affect the respondent's ability to continue in business, the Initial assessment should reflect this consideration and such mitigation as is appropriate. Should it be clear at the outset that the respondent will be unable to pay the proposed penalty (evidence of bankruptcy or busines loss available in rare circumstances when the violation is discovered), a penalty complaint should be filed nonetheless noting the absence of any assessment based on inability to pay and follow through to an appropriate final order. In such case, respondent retains the right to contest such complaint and allegation of violation. (In no other situation should "zero" penalty occur.) In the absence of information about respondent's inability to pay, the initial presumption will be that the assessment of the proposed .penalty In no case should a threat by respondent to go out of business voluntarily if a penalty is assessed be considered as evidence of inability to pay. The Gravity of the Violation. The gravity of any violation is a function of the following factors [see Amvac Chemical Corporation Ho. 1I-4C<1974) j: The potential to injure humans or the environment, The severity of the potential injury, The scale and type of product use anticipated, The identity of the persons exposed to the risk of injury, The extent to which the applicable provisions of the Act were in fact violated, -3hB 'TJirl j^fTT^f ^*^fftin y -*¥f ' fwrfy'i^*'rtvf aTM^ actual •IcBovledse -iff Act, and Any evidence of good faith. cpap 11 ance/mrorL* mt1 nt /-*»> Guidance Manual ------- Chapter Seven Complaint Fr*9*ration and Filing History of compliance and good faith may be considered to include activi- ties under FIFRA as amended in 1972, 1975, 1978, and under the 1947 FIFRA, provided that such history does not include any complaint or notice to which respondent made answer or explanation and which was not further pur- sued by the complainant [see In Re Beaulieu I.F.&R. No. IX-10C(1974)]. A prior notice without any further action may be considered by the complai- nant in determining the issue of respondent's prior knowledge of the Act. Penalty Assessment Guidelines EPA has established a penalty assessment system that initially assesses a penalty amount based on the nature and extent of the violation and then adjusts this amount in consideration of mitigating or exacerbating fac- tors. The guidelines for assessing civil penalties are provided in Appendix 6 of this manual. Independently Assessible Charges A separate civil penalty should be assessed for each violation of the Act that results from an independent act (or failure to act) by the respondent and is substantially distinguishable from any other charge in the complaint for which a civil penalty is to be assessed. A given charge is independent of, and substantially distinguishable from, any other charge when it requires an element of proof not needed by the others. (See Elements of a Violation: Administrative in Section 2 of this chapter.) Mot every charge that appears in a complaint can be separately assessed. Where a charge derives primarily from or merely restates another charge, a separate assessment is not warranted. Charges that do not support a separate assessment are to be indicated in the complaint as "lesser included charges."* Multiple Misbranding Multiple instances of pesticide and device misbranding, however, are not independently assessible when there is a shipment of a single pesticide See In the Matter of Pearson & Company, I.D. Nos. 88176, 88468, 90943, Initial Decision by ALJ Bernard D. Levinson, May 31, 1974; and In Ret Chapman Chemical Company, I.D. No. 104559, amended Final Order by R. A, Jack E. Ravan, July 29, 1975. See also Blockburger v. United States, 284 U.S. 299 (1932); and Tesciona v. Hunter, 151 F.2d 589 (10th dr. 1945). FIFRA Compliance/Enforcement 7-50 Cnida*"^ Manual 1983 ------- Chapter Seven Complaint Preparation and Filing product.* Multiple misbrandings must appear either: • As lesser included charges to accompany a count of misbranding; or • As allegations in a single count. In either case, only a single civil penalty should be assessed. The gravity of the single violation involving several label deficiencies, however, may be determined to be greater than that of a violation involving only one misbranding. Thus it may support a higher penalty than that proposed for ^single misbranding, A proposed penalty may be derived by locating on the penalty matrix a figure for one of the misbranding violations and increasing that figure up to as much as $5,000. The Increase would depend on the number and/or seriousness of the additional misbrandings, as well as whether they are cited as primary or lesser included charges. -•';.C plaint Preparation Since the complaint Initiates an administrative civil penalty action and is the focal point for all subsequent proceedings, it must be as complete as possible. Failure to file a complaint that meets the standards and proce- dures outlined in this chapter may: • Cause a delay in the proceedings; • Prevent the complainant from being granted a motion for default under Section 22.17 of the CROP; and • Make the complainant subject to adverse motions by other parties to the proceedings. Checklist of Complaint Requirements 22»14(a) ** The following elements are considered necessary to establish the legal 1. Statement reciting the section(s) of the Act authorizing the issuance of the complaint; * See In the Hatter of Hawk Industries, Inc., I.F.&R. Docket No. II-120-C, issued by ALJ Bernard 0. Levinson, December 21, 1976. goabers To the l:cft of ^ach-of 'the -following Items correspond to numbers In Exhibit 7-1, which shows a sample complaint. The numbers in the exhibit Identify examples of each kind of Information. FIFRA Compliance/Enforcement7-5 ------- Chapter Seven Complaint Preparation and Filing 2. Specific reference to each provision of the Act and to the regulations that the respondent is alleged to have violated; 3. Concise statement of the factual basis for alleging the violation; 4. Statement explaining the proposed penalty; 5. Copy of the Agency's "Guidelines for the Assessment Section 14(a); Citation Charges for Violations," 39 Fed. Beg. 27711 (1974); 6. Proposed amount of civil penalty to be assessed; 7. Notice of respondent's right to request a hearing on any material fact contained in the complaint or on the appropriateness of the amount of the proposed penalty; 8. Copy of the Consolidated Rules of Practice (CROP); 9. Notice of opportunity for an informal settlement conference; and 10. Date and signature with notation of title of a duly authorized official of the Agency. Elements of the Complaint The discussion under each element of the complaint gives the purpose of the element and in some cases the reason for its particular place in the complaint. Caption • Identification of Respondents (A)»* Respondents, or those against whom the complaint is filed, are to be accurately and Individually identified on the left side of the caption. • Docket Number and Subjects of the Complaint (B). The I.F.&R. Docket Number and matters addressed In the complaint are to be properly Identified on the right side of the caption. Docket numbers are assigned by the Regional Hearing Clerk. The docket number designates the Region involved In Roman numerals followed by the case number (e.g., I.F.&R. Docket No. IZ-10C). The docket number must be accurately reflected in the caption, because It Is the identifying number for all subsequent documents filed in the proceedings. * The letters in parentheses to the right of each element correspond to the letters in Exhibit 7-1. FIF1A QmpHance/Enforceaent 7-52 Guidance Manual 1983, ------- Chapter Seven Complaint Preparation and Filing Jurisdictional Authority (C) The complaint must contain a statement of Jurisdictional authority that informs the Presiding Officer and the respondent of the statutory authority under which the complaint is issued. This statement should be in the beginning of the complaint and should be as specific and precise as possible. 22.14(a)(l) Factual Allegations (D) In this section of the complaint, the specific facts of a particular violation are tied to the statute, rule, regulation, and/or order that allegedly has been violated. The goal of this section is to adequately Inform the Presiding Officer of the alleged violations and to inform the respondent of the charges so that an adequate response can lie prepared . Violations are identified by the particular sample (ID) number. In the event of a complaint containing multiple sample (ID) numbers, the discussion of each separate sample (ID) should contain an enumeration of the facts and circumstances of each separate violation related to that sample. The proposed penalty assessment should include an enumeration of the dollar amount proposed for each violation charged with respect to that sample or an indication that a particular charge is "lesser included" and bears no penalty assessment. The factual allegations of the complaint, including multiple samples, should be separated into paragraphs. In -making "factual allegations , the key -word is "concise ."" *" Conciseness" means that all material facts necessary to establish the factual basis for each violation are specified, while extraneous or irrelevant information is omitted. Although the purpose of this section is only to Inform the respondent and Presiding Officer of the facts that the alleged violation is based on, all relevant facts should be included rather than risk failure to meet the requirements set forth in the CROP. For instance, even though the respondent may have been present when certain facts were ascertained, those £ac£« vxat *tlll 'to iadadsd to Jafexm tte xa*poadent «nd the Presiding Officer of their legal significance. 22.14------- Chapter Seven Complaint Preparation and Filing Amount of Civil Penalty and Rationale (F, G) This section of the complaint is intended to: • Explain the reason for the proposed penalty (F) in a manner that reflects the fact that the Agency has considered the penalty assessment factors specified by Section 14(a)(4) of FIFKA. Every detail of the Agency's reasoning process need not be reflected; however, the section should state that the FIFRA criteria were considered in assessing the penalty. In order to help meet the statutory requirement without unnecessary elaboration, a copy of the Agency's policy in assessing FIFRA civil penalties should be attached to the complaint; and 22.14(a)(5) • Specifically identify the proposed penalty amount (G). 22.14------- Chapter Seven Co^pTa*™*- Preparation and Filing Service of the Complaint The respondent Is served with a copy of the complaint In either of the following manners: 22.05(b) • Personal service. The complaint and accompanying documents are left with the respondent .or an . authorized representative; or • Service by certified mail, return receipt requested. The complaint and accompanying documents are mailed to the respondent or an authorized representative. Personal Service Fox personal service on an individual at. a business address, the «'"t"r1a-iTrt is left 'with the respondent or a person who Is In charge of the office, such as an office manager, or a person who is responsible for the respondent's administrative affairs, such as a personal secretary. For personal service on a corporation, company, or association, the complaint is left with an officer, partner, managing or general agent, or any other person authorized by appointment or by Federal or State law to receive service of process. For personal service on a named Individual at a residential address, the complaint is left with any person of suitable age and discretion who resides there. Service by Mall If the complaint is addressed to an individual person, it should be mailed to the last known business address by certified mail, return receipt requested. i'------- Chapter Seven Complaint Preparation ar»d Service Upon U.S. Government Officials or Agencies Service upon an officer or agency of the United States must be made by delivering a copy of the complaint to the officer or agency, or in the manner prescribed by applicable regulations. If the agency is a corporation, service may be either personal or by certified mail directed to an officer, partner, managing or general agent, or any other person authorized by appointment or law to receive service of process. Service on State or Local Government Entities or Officials Service upon a State or local unit of government, or a State or local officer, agency, department, corporation, or other Instrumentality must either be made in the manner prescribed by State law or upon the chief executive officer of the governmental unit or the State or local officer. 22.05(b)(l)(iv) Certificates of Service Proof of service must be made either by a properly executed affidavit of service (Exhibit 7-3) for personal service, or by a properly executed return receipt, for service by mail. A certificate of service must be filed with the original complaint. 22.05(b)(l)(v) Filing the Complaint The original and one copy of the complaint (with proof of service) must be filed with the Regional Hearing Clerk. 22.05UX1) FIFRA map 11 rrnrr/rnfnrcracnt 7-56 Guidance !*«"""»' 1983 ------- Chapter Seven Exhibit 7-1 Sample Complaint UNITED STATES ENVIRONMENTAL PROTECTION AGENCY BEFORE THE ADMINISTRATOR In re: (A) Firetog Industries, Inc. 36 Sunshine Drive, Clark, MA 02856 Respondent I.F.&R. Docket No. 1-420C (B) COMPLAINT AND NOTICE OF OPPORTUNITY FOR HEARING COMPLAINT (C) This civil penalty action Is Instituted pursuant to the authority vested in the Administrator of the United States Environmental Protection Agency by Section 14 [7 U.S.C. §1361] of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (hereinafter referred to as FIFRA). The complainant in this action is John Doe, Division Director, Enforcement Division, Region I, United States Environmental Protection Agency, who has been duly authorized to institute this action. The respondent in this action is Firetog Industries, Inc. Allegations or Counts (D) This Is to notify you that there is reason to believe respondent has violated Section 12 [7 U.S.C. S136J] of FIFRA. The pesticide listed below is not in compliance with provisions of FIFRA as specified. (B) I.D. No. 152049 - MOLD STOP (EPA Registration No. 3681-3), which was being held for sale or distribution by your establishment in dark, Massachusetts, on January 29, 1983, was: 1. Misbranded In that the label stated, in part: "* * * MOLD STOP * * * ACTIVE INGREDIENTS: 25Z Propionic Acid * * *- FIFRA Compliance/&xforceaent 7-57 1983 ------- Chapter Seven Exhibit 7-1 whereas, when tested, the product did not contain 25Z Propionlc Acid. [PIFRA Sl2(a)(l)(E), 7 U.S.C. S136J(a)(l)(E); FIFRA S2(q)(l)(A), 7 U.S.C. Sl36(q)(l)(A)J 2. Adulterated in that Its strength or purity fell below the professed standard or quality under which It was being held for sale. [FIFRA §12(a)(l)(E), 7 U.S.C. §136j(a)(l)(E); FIFRA S2(c)(l), 7 U.S.C. Sl36(c)(l)] (When analyzed, the product was found to contain only 13.812 and 14.232 Propionic Acid in two separate tests.) Proposed Civil Penalty (F) In arriving at the assessment of the penalty specified below, the Environmental Protection Agency, as required by Section 14(a)(4) of FIFRA [7 U.S.C.$1361(a)(4)], has taken into consideration the following factors concerning the respondent: • The size of respondent's business; • The respondent's ability to continue in business, in light of the proposed penalty; and • The gravity of the alleged violation. Agency policy with respect to assessment is governed by the Environ- mental Protection Agency's "Guidelines for the Assessment Section 14(a); Citation Charges for Violations" [39 Fed. Beg. 27711 (1974)], a copy of which is attached to this complaint. (6) Based on the above considerations, the Environmental Protection Agency proposes to assess a civil penalty in the amount of three thousand, seven hundred and forty dollars ($3,740) against Firetog Industries, Inc. Notice of Opportunity To Request a Hearing (H) This administrative civil penalty proceeding will be conducted pursuant to the Consolidated Rules of Practice (CROP) [40 C.F.R. 122.01 et seq. 1, a copy of which accompanies this complaint. Pursuant to~"the CROP, you have the right to request a hearing to contest any factual allegation set forth in the complaint or the appropriateness of the proposed penalty. In the event that you wish to request a hearing and to avoid having the above penalty assessed without further proceedings, you must file a written answer to this complaint with the Regional Bearing Clerk, United States Environmental Protection Agency, Region 1, John F. Kennedy Federal Buldling, Boston, Massachusetts 02203. FIFRA Compliance/Enforcement 7-58 0^14^** Manual 1983 ------- Chapter Seven Exhibit 7-1 If you do not request a hearing or file a written answer within twenty (20) days of receipt of this complaint, the above penalty will be assessed without further proceedings, and you will be so notified. Settlement Conference (I) The Environmental Protection Agency encourages all parties against whom a civil penalty is proposed to pursue the possibility of settlement as a xesult of informal conferences. Therefore, whether or not you request a hearing, you may confer Informally with the Agency concerning (1) whether the alleged violation In fact occurred as set forth above, or (2) the appropriateness of the proposed penalty in relation to the size of your business, the gravity of the violation, and the effect of the proposed penalty on your ability to continue in business. The request for an Informal conference does not stay the running of the twenty (20) day time period for requesting a hearing and filing an answer. To explore the possibility of settlement In this matter, contact "Jtev-aKfttie 4Smitn, Enforcement ^Division, United States Environmental Protection Agency, Region 1, John F. Kennedy Federal Building, Boston Massachusetts 02203, telephone (312) 989-9876. 0. (J) John Doe Director, Enforcement Division Jfete: Charges for Violations Consolidated Rules of Practice (CROP) FIFRA Compllance/Enforceaent 7-59 Guidance timrnal 1983 ------- Chapter Seven Exhibit 7-2 Cover Letter UNITED STATES ENVIRONMENTAL PROTECTION AGENCY Region I John F. Kennedy Federal Building Boston, MA 02203 CERTIFIED MAIL RETURN RECEIPT REQUESTED 6.B. Stubbs, Registered Agent Firetog Industries, Inc. 36 Sunshine Drive, Clark, MA 02856 Dear Mr. Stubbs: As the enclosed complaint and notice of opportunity for hearing indicates, the United States Environmental Protection Agency has initiated an administrative civil penalty proceeding against Firetog Industries, Inc., for violations of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (7 U.S.C. S136 et seq.)« It is suggested that you carefully read and analyze the complaint and the enclosed Consolidated Rules of Practice (40 C.F.R. 522.01 et seq.) so that you are fully apprised of the alternatives offered to you in considering the alleged violation, proposed penalty, and opportunity for a hearing. You will note that you have only twenty (20) days from your receipt of this notice within which to file an answer to the enclosed complaint with the Regional Hearing Clerk, United States Environmental Protection Agency, Region 1, John F. Kennedy Federal Building, Boston, Massachusetts 02203. Failure to file a timely answer, in writing, will result in a default order being entered % against you for the full amount of the assessed penalty. The Agency encourages all parties against whom a civil penalty proceeding has been Initiated to pursue the possibility of settlement through Informal conferences with the Agency. Therefore, regardless of whether you request a hearing, you are extended the opportunity to request an Informal settlement conference. To request a conference, please write to Ms. Kate Smith, United States Environmental Protection Agency, Region 1, John F. Kennedy Federal Building, Boston, Massachusetts 02203, or telephone Ms. Smith at (312) 989-9876. Any discussion you may have with Ms. Smith will not affect the time period in which you are permitted to request a hearing or file an answer to the complaint. Sincerely, John Doe Enclosure Director, Enforcement Division FIFBA Coapllaffice/Eflforcaasnt 7—60 c*t4A*mc<* ttan^mt 1983 ------- Chapter Seven __ Kadhlblt 7-3 Model Affidavit of Service AFFIDAVIT OF SERVICE UNITED STATES OF AMERICA UNITED STATES ENVIROHMENTAL PROTECTION AGENCY I hereby certify that being a person over 18 years of age, I served a copy of the within complaint (check one) ( ) In person ( ) by registered mall, return receipt requested ( ) by leaving the copy at principal place of business, which is ( ) (write in other method, such as leaving it at dwelling, serving registered agent of corporation, etc.) on the person named in the complaint on (month, day, and year)* (Signature of person making service) Qteme t>f person making 'service) (Title, if any) FIFKA Cbmpliance/EnforceBent 7-61 Guidance M«r«aT 1933 ------- Chapter Seven Exhibits FIFRA ------- Chapter Seven 4 Prehearing Stage Intervenors and Amlcus Curiae An individual my sake a notion to become an intervenor In any proceeding conducted under the CROP* To Intervene, the Individual's motion must reflect that: • The individual has a certain interest in the proceeding that is not adequately represented by the original parties; • The Individual's presence will not unduly prolong or otherwise prejudice the adjudication of original parties' rights; and • The individual will be affected adversely by a final order. A motion to become ^n Imtervenor Is ordl-narily^ade before the first TJTeheartng conference, guwever, the ^motion may be made after that time if good cause is shown for the failure to file in a timely manner. A party objecting to the intervention may make an answer to the motion to intervene within 10 days following service of the motion. Once an individual is permitted to intervene, that individual becomes a full party to the proceeding. 22.11(a), 22.ll(b), 22.11(c>, 22.03(a) must Identify the Interest of the applicant and the desirability of the proposed amlcus brief. If the motion is granted, the Agency official granting the motion specifies the time for filing the brief. Once the notion is granted, the individual, while not considered a full party, is permitted to file amlcus briefs in all subsequent briefings during the proceeding and is served with copies of all documents relating to such 22-ll------- Chapter Seven pr»iM»aT-<« stae Agency Files The Agency must maintain at least two files — one that is initiated by the Regional Hearing Clerk and one that is initiated by the Presiding Officer upon assignment to a case. In addition, an enforcement official bringing the action must maintain a separate file with duplicates of all documents filed in the proceeding. (See Regional Pesticides Enforcement Case File in this section.) 22.05(a)(l), 22.05(a)(2) If the action is initiated at the national instead of the regional level, certain terms should be substituted for the terms set forth below. (See Regional Versus National Actions in Section 1 of this chapter.) Files of Regional Hearing Clerk and Presiding Officer All substantive documents served in the proceeding must be filed with the Regional Hearing Clerk. The Regional Hearing Clerk initiates this file after receiving the original and one copy of the complaint and the accompanying certificate of service. All original copies of filings and communications from Agency officials, including those from the Presiding Officer, are to be maintained in the Regional Hearing Clerk's file. The Presiding Officer's file contains copies of all correspondence, except for correspondence from the parties jo the Presiding Officer. Originals of such correspondence are kept by the Presiding Officer. The documents that are filed with the Regional Hearing Clerk include: 22.05(a) • Original and one copy of the complaint; • Originals and copies of certificates of service; • Original filings of any intervenors; • Original answer received from the respondent; • Original and one copy of rulings, orders, decisions, and other documents that are issued by the Regional Administrator, Regional Judicial Officer, or Presiding Officer; 22.06 • Originals of direct correspondence from the Presiding Officer jto the parties; and • Copies of direct correspondence from the parties to the Presiding Officer. gnxorrciac me /~OH Guidance ------- Chapter Seven Prp***"*-rlng Stage Copies of the above documents oust be maintained In the Presiding Officer's file, except for correspondence from the parties to the Presiding Officer. The originals of such correspondence are kept by "tEe Presiding Officer. Regional Pesticides Enforcement Case File The Agency enforcement official initiating a complaint maintains a separate file containing duplicates of all documents filed in the proceeding, as well as other enforcement documents relating to the case. Documents in this file include: • Copies of all documents filed with the Regional Hearing Clerk or Presiding Officer; • Any internal EPA documents used in generating the enforcement action (e.g., concurrence documents, checklists, etc.); • EPA investigative records such as laboratory reports and copies of business records; • Original Penalty Assessment Worksheet(s); • All correspondence between the respondent and other EPA parties; and • All correspondence between EPA and other Federal or State agencies (e.g., the Department of Justice). This file shall be retained for a minimum of five years in the Region after termination of the case, after which time it should be transferred to ?Jtecords Control Center. Filing Requirements A document is considered sufficient for filing if: • It contains, on the first page of the document, a caption that Identifies the respondent and the docket number assigned for the It bears the signature of the filing party, counsel, or other representative (except for exhibits); and 22.05(e)(3) • It tears *frg pane, g^drfp,, a"d. '•plephmff ""iit^tr -gf the by person. Any changes in this information must be sent to the Hearing Clerk, Presiding Officer, and all other parties to the F1KKA OoBpliance/Enr'orce.ent 7^55 MA^- Manual 1983 ------- Chapter Seven Pr»frear*"g Stage proceeding. If a party fails to provide or, when appropriate, amend this information, the right to notice and service is waived. 22.05(c)(4) The Agency official with Jurisdiction over the proceeding may prescribe additional requirements for the form of documents. 22.05(c)(l) If the applicable requirements are not met, the Agency official receiving the filing may refuse to accept it until it is properly amended. Permis- sion to amend is granted only upon motion to the Administrator, Regional Administrator, or Presiding Officer who refused to file the defective document. 22.05(c)(5) Also, any party filing a document after the complaint has been issued must certify that copies of the document have been sent to other parties, appropriate Agency officials, and any amlcus curiae. While the CROP do not give explicit sanctions for failure to provide an appropriate certificate of service, failure to serve copies of documents on individuals who have a right to notice may delay the proceeding and, In some cases, may even result In an otherwise entirely correct proceeding being dismissed by the Presiding Officer or being overturned on appeal. 22.05(a)(2) Public Access to Documents Filed Subject to any confidentiality requirements specified by law, the documents filed in the proceeding must be made available by the Regional Hearing Clerk for public inspection during business hours. 22.09U) Prohibition of Ex Parte Discussion After a complaint has been issued, certain Agency officials are prohibited from discussing ex parte (i.e., without notice to all parties) the merits of the proceeding with Individuals or their representatives who have an Interest In the proceeding. 22.08 Although ex parte discussion about the merits of a proceeding Is prohibited, If such communication occurs, it Is regarded as argument, and a copy of the ex parte communication is served on all other parties In the proceeding. Those other parties are then afforded an opportunity to reply. Failure to comply with these provisions of the CROP can taint an otherwise entirely correct proceeding and may result in Its dismissal by the Presiding Officer or In the action being overturned on appeal. torceaent 7-66 ------- Chapter Seven _ Prphearing Stage The Agency officials subject to ex parte prohibitions are: • Administrator; • Regional Administrator; • Judicial Officer; • Regional Judicial Officer; • Presiding Officer; and • Any other person who is likely to advise these officials (e.g., the Associate Administrator for OLEC and the Assistant Administrator for Pesticides and Toxic Substances). The Agency officials listed above are prohibited from participating in ex. parte discussions with the following Individuals: * Jn Agency -jaff Icial .who<&KC£oraa.-a .prosecutorial or investigative function In the proceeding or a factually related proceeding; • Any person outside the Agency who has an interst in the proceeding; and • Any representative of the persons identified above. Answer to the Complaint The respondent -gust respond to -the allegations in the complaint within 20 days after service of the complaint.* The response is in the form of an answer. In the answer, the respondent must admit, deny, or explain each of the factual allegations contained in the complaint. Where the respondent has no knowledge of the allegations and makes a statement to that effect, the allegations are considered denied. 22*15(b) Failure to admit, deny, or explain any material factual allegation contained In the complaint" constitutes an admission of that allegation. 22.15(4) Procedural Considerations Before the answer Is filed, all notions are made to the Administrator or Regional Administrator, or the Judicial Officer or Regional Judicial * Service of the complaint is complete when the return receipt is signed (if the complaint was mailed) or when personal service is effectuated. FXrRA. Coapllance/BDZorcement 7-67 oi^^t^ Manual 1933 ------- Chapter Seven Pr»tn.pi-f^g stage Officer, as appropriate. After the answer is filed, a Presiding Officer is designated, and all motions are made to that official. 22.16(c) Filing a timely answer precludes the complainant from seeking a motion for default based on the failure to file a timely answer. 22.17(a)(l) Filing a timely answer lessens complainant's opportunity to amend since, as a matter of right, the complainant may amend the complaint once before the answer is filed. Otherwise, a motion must be made to and approved by the Presiding Officer. 22.14(d) The complainant may withdraw the complaint, all or in part, without prejudice one time before the answer has been filed. After one withdrawal before the filing of an answer or after the filing of an answer, the complaint may be withdrawn only upon motion granted by the Presiding Officer or Regional Administrator. 22.14(e) Sufficiency of Answer The answer must meet the following requirements: • Filing the original of the answer with the Regional Hearing Clerk; and • Complying with the general filing, service, and content requirements specified by the CROP. 22.05 The contents of the answer must include: • Clear and direct admissions, denials, or explanations of each factual allegation contained in the complaint of which the respondent has any knowledge. If the respondent has no knowledge of a particular factual allegation and makes a statement to that effect, the allegations are considered denied. All allegations should be addressed in some manner; • Grounds for defense; • Facts that the respondent will put in issue; and • Any request for a hearing. 22.15(b) FXFiA CDBpli4a.ee/Enforceaeiit T--68 Guidance Manual 1983 ------- Chapter Seven Prrheiiring Stage Evaluation of Answer Upon receiving a copy of the answer, the complainant should immediately review it for any deficiencies and also check with the Regional Hearing Clerk to ensure that the requirements concerning timely filing and the general filing requirements have been met. Review of the answer might also indicate that a motion to amend the complaint is warranted (i.e., if proposed penalties should be reduced or increased). Consequences of Deficient Answer If the form requirements specified by Section 22.05(c) of the CROP are not complied with, the Regional Hearing Clerk can refuse to file the answer. 22.05(c)(5) If the requirements specified by Section 22.15(b) of the CROP are not complied with, the insufficient answer may be regarded as an admission of the matter(s) not sufficiently discussed. If the answer is not filed within the time requirement (20 days), the complainant can seek a default order. 22.17(a)(l) Prehearing Motions Motions may be made by the parties before a hearing is convened. Before £be filing of an ansver^ ootionf are filed with the Regional j.ddaltri «trator. After the filing of -an xncwer^ action* «*re £ll«d with Presiding Officer. 22.16(c) Written Motions All motions made during the proceeding, except those made orally on the dnxlag m- hearing «nst : • Be in writing; • Specifically state the grounds or basis for the motion; • Specifically identify the action(s) that the motion seeks; uoapj^ance/ioiiorceaent 7—69 aniAmn^f MMMUII 1903 ------- Chapter Seven • Be accompanied by any evidence that is being relied upon by the movant (e.g., affidavits and legal memoranda); and • Be served upon the parties. A written motion must also comply with the general filing and service provisions of Section 22.05 of the CROP (i.e., It must be properly signed, accompanied by appropriate certificates of service, and bear an appropriate docket number). Since a transcript is required only In a hearing and may be used in prehearing conferences at the discretion of the Presiding Officer, most motions made before the hearing will probably have to be in writing and conform with the requirements specified by Section 22.16(a) of the CROP. 22.19(c) Reply to Motion A party's response to any written motion must be filed with the Regional Hearing Clerk within 10 days after service of such motion, except in Che case of a motion for a default order, which specifies a 20-day period for replies. Like all documents filed in the proceeding, replies to motions must bear the docket number and comply with the filing and service requirements specified by Section 22.05 of the CROP. 22.16------- Chapter Seven Prehearing Stage • Motion for default for failure to comply with a prehearing order of the Presiding Officer; 22.17(a)(2) • Motion for default for failure to appear at a conference or hearing convened by the Presiding Officer pursuant to Section 22.19 of the CROP; 22.17(a)(3) • Motion for consolidation or severance; and 22.12(a), 22.12------- Chapter Seven prphoa^tyg Stage This time period Is 10 days longer than that generally specified for replies to motions (Section 22.16(b) of the CROP). Default Order as Initial Decision A default order at the time it is issued by the Presiding Officer (Regional Administrator or the Regional Judicial Officer, if a timely answer is not filed) constitutes an initial decision of the proceeding. As such, it must: 22.17(b) • Contain findings of fact, conclusions regarding material issues of lav or discretion, and the recommended penalty; and 22.17(c) • Be filed with the Regional Hearing Clerk. 22.17(b) The Regional Hearing Clerk must serve copies of the initial decision on all parties to the proceeding and otherwise comply with Section 22.27 of the CROP, which addresses transfer of the proceeding's record to the Hearing Clerk. The default order becomes the final order of the Administrator within 45 days after its service upon the parties unless (1) the default order is appealed or (2) the Administrator elects, sua sponte, to review the default order. Appeal A default order may first be appealed by a motion to set aside the default order made to the Agency official who issued the default order. Any further appeal of the default order must be made directly to the Administrator pursuant to Section 22.30 of the CROP. 22.17(d), 22.29(a) Consequences of Final Default Order When the Administrator Issues a final order upon default against the respondent, respondent is subject to the following consequences: • The respondent has essentially "admitted*' to all facts alleged in the complaint and the right to a hearing is waived; and • The penalty proposed In the complaint will become due and payable within 60 days after the final order is Issued. 22.17(a) The admission of factual allegations and waiver of hearing applies only to the immediate civil penalty proceeding and does not affect any other proceedings. In addition, the 60-day period for payment of the penalty begins only after the Administrator has issued a final order upon default, not after the Presiding Officer Issues the initial default order. FXFRA Compliance/Enforcement 7-72 Guidance Manual 1983 ------- Chapter Seven Prehenrlng Stage When the Administrator issues a final order upon default against the complainant, the complaint is dismissed with prejudice. If the complaint is dismissed with prejudice, the complainant cannot reinstitute a civil penalty proceeding that is based on the allegations in the dismissed complaint. Settlement EPA encourages settlement of a'civil penalty proceeding, if the settlement is consistent with the provisions and objectives of FIFRA and its applicable regulations. 22.18(a) Procedures A settlement conference can be requested at any time. The parties may confer on settlement whether or not the respondent has requested a hearing. Before an answer is filed and a Presiding Officer is appointed, settlement conferences can be convened by consent of the parties. After a Presiding Officer has been appointed, settlement conferences are subject to the Jurisdiction of the Presiding Officer who may order a prehearing conference settlement. As an alternative, the parties may be directed to correspond with the Presiding Officer concerning settlement. 22.18, 22.19 Consent Agreement and Proposed Consent Order If r.aa«ett lament Is reached by ^tne parties , -they ^must forward a written consent agreement (see Exhibit 7-5) and a proposed consent order to the Regional Administrator. In addition, they must serve copies of these documents on the Presiding Officer if one has been appointed. The consent agreement must contain the following Information before the Regional Administrator can approve it: 22.18(b) e: of all .parties or tfaair representatives in the •proceeding (e.g., complainant, respondent, and any intervenors) ; • A statement In which the respondent admits that the Agency has Jurisdlctlonal authority to bring the complaint; • A statement In which the respondent admits facts stipulated In the consent agreement or neither admits nor denies facts alleged In the A statement in which the respondent consents to the assessment of the stated civil penalty that is reflected In the consent agreement and proposed consent order. FXFKA GompJLiance/Enforcement 7—73 Guidance tlamiil 1983 ------- Chapter Seven pr»ho.^i«g stage Also, the consent agreement must Include any and all terms of the agreement among the parties. Consequently, any terms to which the parties have agreed in reaching a settlement must be reflected in the consent agreement (e.g., agreement not to pursue criminal penalties, agreement by intervenor not to pursue private damage remedies, agreement by the respondent to taVe actions that minimize the effect of the violation, etc.). Partial settlement of the proceedings is permitted and, in many cases, is likely. Settlement agreements and proposed consent orders must be very carefully drawn and completely understood before signatures are obtained so that the parties understand precisely what elements of the matter are not disposed of by the consent agreement and consent order. The consent agreement becomes final and binding on the parties only after the Regional Administrator has signed the consent order. The consent order disposes of only those elements of the proceeding that are specifically addressed by that order and the consent agreement. t The proposed consent order must be prepared for the Regional Administrator's signature. It need not restate all the terms of the consent agreement, but it must at least explicitly incorporate by reference the consent agreement as being the basis for the consent order. 22.18(c) The Regional Administrator, in deciding whether to issue a final consent order, may require parties to the settlement to appear in person to answer questions relating to the proposed consent agreement or order. Filing of Consent Agreement and Order The consent agreemeent and the final consent order constitute Important documents that affect the substantive and procedural rights of the parties. Consequently, the originals of these documents must be placed in the Regional Hearing Clerk's file, and copies must be served as required by Section 22.06 of the CROP. Prehearing Conference When a hearing is ordered, the Presiding Officer also convenes a prehearing conference, unless it appears unnecessary. Prehearing conferences are intended to facilitate and expedite a hearing proceeding. These conferences encourage informal, frank discussions among the parties on any matter that could expedite the hearing. Any anticipated problems should be discussed at this time. The prehearing conference may involve: 22.19(a) • Settling the case; FIFKA compliance/Bixorcement 7-74 0*1+?**•* Manual ------- Chapter Seven Preheating Stage • Attempting to simplify the proceeding through consolidation of issues and stipulation by the parties; • Amending the pleadings; • Exchanging information concerning evidence to be presented (e.g., identities of expert witnesses and summaries of their testimony and exchange of exhibits, documents, and prepared testimony); • Limiting the number of witnesses; • .-Setting a time .and place for the hearing ; and • Attending to any matter that may expedite the disposition of the proceeding . Exchange of Information The CROP generally require that the parties exchange witness lists., brief descriptions of witness testimony, and copies of sll documents and -physical evidence that will be Introduced into evidence. This requirement supports the accepted manner of hear ings —one that is forthright and avoids surprise . 22. 19(b) Failure To Exchange Information If the party does not exchange information before the hearing and desires to introduce a document or a witness during the hearing, that party must request the permission of the Presiding Officer. Additionally, if such permission is granted, the Presiding Officer must first allow .other parties y •*»<*it*» -t*»-.Tyri-f»». tfag ruM^iy jpr-rf^fn^^ evidence. Protection of Evidence Sources Certain unusual circumstances may justify not following the policy of early information exchange. One such example Is a reasonable belief that witnesses might be subject to physical or economic intimidation. Another circumstance -Is .a ...reasonable ,he3 iff that -the ^nature of the documentary or ^physical evidence would perait xthe respondent £o intimidate witnesses , destroy evidence, or otherwise Improperly Interfere with the enforcement efforts of the Agency. In such situations, the Presiding Officer should be fully Informed of the reasons for withholding evidence or the Identity of a particular witness. JLole «of vj&scovery The CROP state that evidence that is not subject to the mandatory exchange of witness lists and documents in the prehearing conference , shall be subject to discovery only upon determination by the Presiding Officer. FIFKA Compliance/Boxorceaent 7-75 Guidance H"""»i 1983 ------- Chapter Seven _____ Pr?hear*"g Stage This provision is primarily intended to address discovery by deposition. To obtain such discovery, a party must make a motion for discovery to the Presiding Officer, which demonstrates that the: 22.19(f) • Proceeding will not be unreasonably delayed by discovery; • Information sought cannot be obtained through alternative means; and • Information sought is of significant probative value. 22.19(f)(l) If the discovery involves oral depositions, then a party must also show that the evidence will not be preserved for presentation by a witness. 22.19(f)(2) The difference between evidence that is subject to mandatory exchange requirements and evidence that may be discovered must be carefully understood. If the evidence being sought should normally be exchanged under Section 22.19(b) and for some reason Is being withheld, then a motion to the Presiding Officer to enforce the requirements of the CROP must be made, not a motion for discovery. If an order for discovery Issued by the Presiding Officer is not obeyed, the inference may be drawn that revealing the withheld information would adversely affect the party withholding it. Also, an order for default may be issued based on a failure to comply with a prehearlng or hearing order. 22.19(f)(4), 22.17(a) An order for discovery is an Important document that affects the procedural rights of the parties. It must, therefore, be Included In the Regional Hearing Clerk's file, and copies must be served in accordance with requirements of Section 22.06 of the CROP. Record of Prehearlng Conference The record of a prehearing conference generally consists of a summary prepared by the Presiding Officer that Incorporates all rulings or orders containing directions to parties and any written stipulations or agreements of the parties. Except for those portions of a prehearlng conference that relate to settlements, a transcript of the prehearlng conference may be made. The transcript Is ordered by the Presiding Officer upon motion of a party or sua sponte. 22.19(c) Settlement conferences, however, are not recorded in order to ensure that the parties are able to negotiate freely and compromise without fear that such agreements will be subsequently revealed. FIFRA Coapllance/Boforcement7-76 ------- Chapter Seven PrehMring Stage The transcript or written summary of the prehearing conference must be filed with the Regional Hearing Clerk for inclusion in the Regional Hearing Clerk's file. 22.06 If a transcript is taken, motions made during the hearing may be oral. However, if no transcript is taken, any motions made must be in writing and must otherwise conform with the requirements of Section 22.16 of the CROP and the filing, service, and content requirements specified by Section 22.05. Motion for Accelerated Decisions and Dismissals Motion for Accelerated Decision The Presiding Officer may issue an accelerated decision either sua sponte or upon atotion ,by the respondent; ox complainant. Hie accelerated decision may Involve a particular issue or the entire case, and may be issued at any time during the proceeding if the Presiding Officer finds that: 22.20 • No genuine issue of material fact exists between respondent and complainant; and • The complainant or respondent is entitled to a judgment as a matter of law. "Entitled to a judgment as a matter of law" means that the movant has established by undisputed or undisputable (not reasonably challenged) evidence that all technical and legal . -elements 'i& -a*viaP'iL'ytJ:PTi-'ii^i"''riffpcifT":^Bri vts^^t t 'fgom^iwtif ly t tite Presiding Officer vast decide a particular issue or the entire case in the movant's favor at that time. Because there Is nothing to adjudicate, there Is no need for a hearing. A discussion of all of the relevant precedents and considerations that apply to a motion for an accelerated decision is not feasible in the space allowed. However, some general principles can be discussed. essential position of ~the other party's case. The notion asserts that, under the facts and law of the case, the adverse party's position is entirely without merit* In this sense, it is not merely a technical notion—that is, one which seeks to establish that the manner or form of the other party's pleadings Is technically insufficient to establish A defense or a claim. It would not, for example, seek to establish that the respondent's defense pleadings lack discussion of an essential element of pleadings by demonstrating that, irrespective of those pleadings, the facts and law of the case require a judgment in favor of the moving party. 7-77 ------- Chapter Seven Prehearing Stage Facts. By requiring that no genuine material Issue of fact exists between the parties, the standard for an accelerated decision does not mean that the parties must agree on all material facts. Instead, the material facts may be either undisputed, or undisputable, that is, not reasonably challenged. Affirmative Defenses. The complainant must demonstrate entitlement to a judgment as a matter of lav. The complainant is required not only to prove the elements of the violation by undisputed or undisputable evidence, but also to address any affirmative defenses raised by the respondent with undisputed or undisputable evidence (e.g., an argument that the respondent relied on Agency advice in violating applicable regulations). Evidence and Burden. The Presiding Officer will probably rely on affidavits and counteraffidavlts in reaching a decision on the motion for an accelerated decision. However, the Presiding Officer may consider any admissible evidence, including stipulations, admissions, expert witness testimony, deposition testimony, and officially noticed evidence. 22.20(a) In deciding whether to grant the motion for an accelerated decision, the Presiding Officer generally gives the party against whom the motion is made every benefit of the doubt. Motion To Dismiss In addition to a motion for an accelerated decision, the respondent can make a motion to dismiss for: • Failure of the complainant to establish a prlma facie case; and • Other grounds that show that the complainant has no right to relief. 22.20(a) To find useful precedent and argument for these standards, the following sources may be helpful: • For the first standard, Rule 41(b) of the Federal Rules of Civil Procedure (Fed. R. Civ. P.), Involuntary Dismissals, and any Federal decisions on this rule; and • For the second standard: - Agency decisions—in which FIFRA standards for an accelerated decision were applied—that relate to failure to state adequate claim or in which the result was required by Justice, and - Federal decisions [involving Fed. R. Civ. P. 12(b) which relates to motions to dismiss] that were based on lack of jurisdiction, insufficient process, or failure to state a claim upon which relief can be granted. FIFRA Caamliance/EnforceBent 7-78 Goldasee *-«""•' 1983 ------- Chapter Seven _____ Prehearlng Stage Partial Decision A decision that grants a notion for an accelerated decision or a motion to dismiss need not dispose of all issues in the proceeding. If such a partial order is issued, the Presiding Officer must also determine which Issues remain in controversy between the parties. To do so, the Presiding Officer must issue an interlocutory order that specifies the issues disposed of by the accelerated decision or dismissal order, and those issues that remain in controversy. 22.20(b)(2) Initial Decision If an accelerated decision or dismissal order is issued to dispose of all issues in the proceeding, such orders are treated as initial decisions and may be appealed to the Administrator under Section 22.30 of the CROP. 22.20(b)(l) If a partial decision is rendered, the objecting party, before appealing, must await the issuance of a final initial decision or obtain 22.20(b)<2), 22.29 An initial decision must comply with the requirements of Section 22.27(a) on content, filing, service, and transfer requirements. FIFBA rrr»pn*- 7-79 ------- 7-80 1983 ------- Chapter Seven 5 Hearing Stage The Presiding Officer convenes a hearing on request by the respondent or, if appropriate, sua sponte—if the matter has not yet been disposed of by a default order, accelerated decision, dismissal order, or consent order. The Chief Administrative Lav Judge appoints a Presiding Officer as soon as the respondent files an answer. 22.21 Notice of Hearing and Venue The Presiding Officer must issue a notice of hearing to all parties, Identifying the time, date, and place for the hearing, at least 20 days before the date set for the hearing. 22.21(b) The hearing is generally held in the county, parish, or Incorporated city where the respondent resides unless otherwise agreed to in writing by all parties. 22.3X*) Any party may make a motion for change of venue. 22.19(4), 22.21(d) In addition, a party may make a motion for postponement of the hearing but must demonstrate good cause for the request. 22.21(c) Presentation of Evidence As Is true for all Agency administrative proceedings , the complainant is the first to present evidence. The complainant must establish a prlma facie case; that is, the complainant must submit evidence that £he events ^^iJSBlBBfl' '';'«Att ~r<^iHmft :*-1^BBB of the Act, and that the proposed civil penalty is appropriate. After the complainant has established a prlma facie case , the respondent must then present any defense to the allegations that are contained in the complaint and any affirmative defenses that are raised by the answer. 22.24 FIFKA. Gompllance/biforcement 7-81 ^lijimrf Manual 1983 ------- Chapter Seven g "Burden of Presentation" and "Burden of Persuasion" are used in the CROP to describe the burden of proof that is placed on the parties in the hearing. 22.24 The definitions are as follows: • Burden of Presentation (Burden of Going Forward With the Evidence)—A party must introduce evidence on the claims or defenses raised in the complaint or answer. • Burden of Persuasion—Each party must convince the Presiding Officer of the affirmative allegations In his or her pleading. The complainant is alleging that a violation has in fact occurred and, therefore, has the burden of presentation. The complainant also has the burden of persuasion. Once the complainant has established a priaa facie case, the burden of presentation shifts to the respondent, who must then introduce sufficient evidence to rebut or outweigh the evidence presented by the complainant. The burden of persuasion never shifts, but remains with the complainant throughout the proceeding; that Is, the complainant always has the obligation of convincing the Presiding Officer, by a preponderance of the evidence, of the allegations contained in the complaint. The respondent has the burden of persuasion with respect to any affirmative defenses raised in the answer—for example, a reliance argument based on Agency advice. The Burden of Presentation initially rests with the respondent but shifts, once the respondent has Introduced sufficient evidence to support a favorable finding. Preponderance of Evidence Each matter contested in the hearing is determined by the Presiding Officer on the basis of a preponderance of the evidence. To prevail, a party must convince the Presiding Officer that, on balance, his or her allegations appear more likely or probable than the other party's allegations. This standard, is different from a criminal standard, which requires a decision based on "evidence beyond a reasonable doubt" or "evidence excluding a reasonable doubt." 22.24 Default Orders and Accelerated Decisions During the hearing, the complainant should keep in mind that a motion for default order (except one based on failure to file a timely answer) or a motion for an accelerated decision may be appropriate despite the advanced stage of the proceeding. FIFSA Qmpllance/Enforceaent7-82 Goldy"*"* **•""•* 1993 ------- Chapter Seven Hearing Stage Hearing Rules of Evidence Under the CROP, the Presiding Officer must admit evidence unless it falls in one of the following categories: • Irrelevant; • Immaterial; • Unduly repetitious; • Unreliable; and • Of little probative value. 22.2(a) When in doubt, the Presiding Officer will most likely admit, not exclude, evidence. Confidential Information The CROP state that, from the outset, confidential information can be introduced as evidence. The Presiding Officer may make such orders as may be necessary to consider such evidence in camera, including the preparation of a supplemental initial decision to address questions of law, fact, or discretion arising out of that portion of the evidence that is confidential or includes trade secrets. 22.22(a) Bnlass otherwise petaltted by the Presiding Officer, vtich « supplemental decision, if issued before the final Initial decision, is to be treated like a partial decision and is not appealable until the final initial decision is issued or certification to appeal an interlocutory decision is obtained. 22.29(a) For confidential commercial information, the complainant should be aware J JJ.S.C. :£19O1 prohibits ttie dJjsclosure of *uch laf oraatlon by a : official,. <8ee also Chapter -Eleven.) Materiality and Relevancy Two standards described In the CROP concern materiality and relevancy. Materiality and relevancy are legal terns of art, and previous cases should £• -fiounsltad to xofettex»&ne tow tbey ------- Chapter Seven jt~fTing stage • Materiality. Material evidence is evidence that is pertinent to or has a legitimate and effective bearing on the case. For example, the evidence relating to the status of an officer within a corporation may be material to proving that he or she knowingly violated FIFRA by manufacturing a certain pesticide. The officer's status within the local church, however, is not likely to be material. • Relevancy. Evidence that Is material may or may not be relevant. Relevant evidence is evidence that has a tendency to make a fact in issue more probable or less probable. The emphasis here is on the probative value of the evidence. The probative value of offered evidence must be assessed in light of the facts in issue. For example, to prove that a reporting violation has occurred, evidence demonstrating that a. particular EPA report was prepared but not sent would surely be relevant. In contrast, evidence that the firm generally failed to maintain good business records might still be considered material but is less likely to be considered relevant or probative. Although materiality and relevancy have technical distinctions, in general, both standards can be viewed in terms of probative value of evidence. If an item of evidence has probative value (i.e., tends to prove or disprove a particular proposition) to the issue for which it is Introduced, then both criteria are satisfied. Evidence Relating to Settlement Any evidence relating to settlement that would be excluded under Rule 408 of the Federal Rules of Evidence (Fed. R. Evid.) is also excluded under the CROP. Rule 408 of the Fed. R. Evid. generally excludes evidence of settlement or attempted settlement when it is offered as proof of an admission of liability. However, this evidence may be admitted for another purpose, such as proving bias of a witness or disproving a contention of undue delay. When such evidence is offered for these purposes, it may still be excluded if the Presiding Officer determines that its probative value is outweighed by confusion of Issues, undue delay, etc. Testimony of Witnesses Witnesses are generally examined orally upon oath or affirmation. The Presiding Officer, however, may allow certain exceptions to this rule (e.g., an affidavit from a dying witness). Any witness appearing at the hearing may be cross-examined if the cross-examination la not unduly repetitious. 22.22(b), 22.22(d) FIFRA GMpllance/Enforeeaemt 7-84 Qaldance Kaaaal 1933 ------- Chapter Seven Hearing Stage Verified Statements in Lieu of Direct Testimony In lieu of direct testimony, a party may desire that a witness admit Into the record previously prepared statements of fact or opinion. Such a request may be appropriate when the testimony is technical or academic and does not lend itself to a clear, cohesive presentation through direct questions. This type of evidence can be admitted only upon the approval of the Presiding Officer. A copy of the written statement must be submitted to the Presiding Officer, reporter, and opposing counsel before It is delivered. The evidence contained in the statement is subject to the same rules of testimonial evidence that apply to oral testimony (e.g., the witness must swear to or affirm the statement and is subject to oral cross-examination concerning the statement). 22.22(c) Affidavits in Lieu of Direct Testimony When a witness is "unavailable," as defined by Rule 804(a) of the Fed. R. Evid., an affidavit may be admitted into evidence in lieu of oral testimony. Older Rule 804(a), witnesses are deemed unavailable if they are exempt by a court order, refuse to testify in spite of a court order, claim lack of memory, are dying or physically impaired, or are absent despite efforts to secure their attendance. 22.22(d) Exhibits and Physical Evidence original -nd one -copy-must be filed vith the Presiding Off leer where practicable. A true copy of any exhibit may be substituted for the original if submitting the original is not possible. Copies must also be furnished to each party. 22.22(e) Official Notice Tft«* 'yrrrf fllTW ft^fiTTT''SMy Ty^y ~ :fff^* r1* y^ :t*r*Tl TT '-trf sny astfrf T j^iT'f **'**^ ^y noticed in the Federal courts, of matters permitted under Rule 201 of the Fed. R. Evld., and of other facts that are within the specialized knowledge and experience of the Agency. Official notice may be sua sponte or upon notion by one of the parties. 22.22(f) 201 ^f £he Jed. JL> ;.£vid« is \dlsd£ed Co thst s»e not sedbject to Tvesonable dispute,and €hat are? Generally known within the territorial jurisdiction of the proceeding; or msipiinnrr/rmrnrrrmf m 7—ay Guidance tlsirir*1 1983 ------- Chapter Seven Hearing Stage • Capable of accurate and ready determination. "Adjudicative facts" directly concern the Immediate parties in the proceeding—who did what, when, where, how, and with what motive or intent. These facts relate to the occurrence(s) alleged by the pleadings, which must be adjudicated to decide the case. The official notice that the Presiding Officer may employ as a result of the special expertise of the Agency is broader than that permitted by Rule 201 of the Fed. R. Evid. Consequently, official notice extends to all matters about which the Agency is presumed expert. For example, the experience and knowledge of the Agency In an environmental area might justify official notice that, statistically, a physical event always occurs under a certain set of environmental circumstances. Objections and Rulings Objections about the conduct of the hearing, such as evidentiary and procedural objections, may be stated orally or In writing. The form of the objection depends on the circumstances. In general, however, if the objection involves a relatively complicated argument and if time permits, it should be written. If it is written, it must comply with the service, filing, and content requirements specified by Section 22.05 of the CROP. 22.23(a) Rulings and Exceptions to Rulings The Presiding Officer must rule on all objections and provide reasons for the rulings, which will become part of the record. Copies of the ruling must be served on the parties by the Presiding Officer and the original entered into the Regional Hearing Clerk's file in accordance with Section 22.06 of the CROP. The CROP also state that to take specific exception to each overruled objection is not necessary. The exception to an overruled objection is automatic and is not waived by further participation in the hearing. 22.23U) Appeal of Ruling A ruling on an objection is not subject to an automatic Interlocutory appeal to the Administrator. A party wishing to appeal the ruling Immediately, must make a motion in writing within six days of notice of the ruling to the Presiding Officer to certify such a ruling to the Administrator. (See also "Appeals of Interlocutory Orders or Rulings" in this section.) FIFBA Compliance/Enforcement 7-86 Quida"*** Manual 1983 ------- Chapter Seven Hearing Stage Unlike other motions made during a hearing, a request for certification may not be made orally, but must be in writing. 22.29'> ^•mmHW,^ .'^••MA' ^PwV^MBt^V^ '- ••^•••••^•^ <^B»^E p^bA^VAB< «Tsbaltte€ to the Presldl-ng ------- Chapter Seven Hearing Stage Proposed Findings, Conclusions, and Orders At the conclusion of the hearing, parties may submit proposed findings of fact, conclusions of law, and orders to the Presiding Officer for consideration in Issuing the Initial decision. The purpose of the proposals and supporting briefs is to advocate positions of the submitting party and to persuade the Presiding Officer to adopt that party's .proposals. Procedures The proposed findings of fact, conclusions of law, and orders, together with supporting briefs, may be submitted to the Presiding Officer for consideration within 20 days of notice of the transcript's availability. The proposals and briefs must be served on the other parties. Although the Presiding Officer must permit reply briefs, the timing of such briefs can be specified. The proposals and all briefs must be in writing and must contain adequate references to the record and authorities relied on. 22.26 Preparation In preparing the proposals, the focus should be on issues that the Presiding Officer must address in the initial decision. The importance of the proposals and briefs cannot be overemphasized. Through these materials, the position of the submitting party can be detailed, and the Presiding Officer can view in depth the merits of the party's position. Initial Decision The Presiding Officer must issue an initial decision as soon as is "practicable" after the period specified for filing reply briefs to the proposed findings, conclusions of law, and orders. The initial decision should contain the Presiding Officer's: • Findings of fact and conclusions for all material Issues of law or discretion; • Seasons for those findings and conclusions; • Recommended civil penalty; and • Proposed final order. uaap a T arTic**/ aazerr "sent /—oo ------- Chapter Seven Hearing Stage In determining the dollar amount of the recommended civil penalty assessed in the initial decision, the Presiding Officer must consider, in addition to the criteria listed in Section 14(a)(3) of FIFSA, the following: • Respondent's history of compliance with the Act or its predecessor statute; and • Any evidence of good faith or lack thereof. The Presiding Officer must also consider the guidelines for the assessment of civil penalties under FIFRA [39 Fed. Reg. 27711 (1974)]. 22.35(c) Specific reasons must be set forth in the initial decision if the Presiding Officer increases or decreases the amount of penalty from that originally assessed In the complaint. The Presiding Officer, however, cannot increase the amount of penalty from that which was recommended in the complaint if the respondent has defaulted. age to Initial Decision The initial decision becomes a final order within 45 days after it is served unless: • A party files a motion to reopen the hearing, which stops the 45-day period until the motion is denied or the reopened hearing is concluded; or 22.28 • A party makes an appeal to the Administrator, or the Administrator determines sua sponte that .a rev-iew ,of the initial .decision is ~. ajipropriat e• 22.27 Motion To Reopen a Hearing _ ,If • .a , jaaxty :belleves .that -.f*i*'**'-i'M*f * evidence ^should • ifee ^iBtxp>rt7j jwy>-vake>a raotlon to reopen o£be bearing. Such a notion must be made no later than 20 days after service of the initial decision on the parties. The motion to reopen the hearing oust state the specific grounds upon which relief is sought, state the nature and purpose of the evidence to be adduced, and show that the evidence Is not merely cumulative. The party must also demonstrate why the evidence was not Introduced at the hearing. The motion must be written and must comply with >sad ^£he filing* •service, and 22.28(a) n'tB •for '' 8 uluittlng documents Compliance/Enforcement 7-89 ani^^n^a ttann»t 1983 ------- Chapter Seven Hffar*"g Stagy Replies from other parties must be made within 10 days after the motion is served. The Presiding Officer must render a decision on the motion as soon as is practicable after the filing of replies. 22.28(b) Filing a motion to reopen a hearing shall automatically stay the running of all time periods (e.g., appeals) until such time as the motion is denied or the reopened hearing is concluded. 22.28(b) Appeals of Interlocutory Orders or Rulings Immediately Appealable Orders The only orders or rulings that may be appealed to the Administrator as a matter of right are: • Accelerated decisions that decide the entire case; 22.20, 22.29 • Dismissal Orders; 22.20, 22.29 • Default orders; and 22.17, 22.29 • Initial decisions rendered after an evidentiary hearing. 22.27, 22.29 All other orders or rulings issued by an Agency official during the prehearlng and hearing proceedings are considered Interlocutory. As such, they must await the issuance of an initial decision before they can be appealed, unless the Agency official issuing such orders or rulings certifies them to the Administrator on appeal. 22.29 Procedures and Standards for Interlocutory Orders A motion for Interlocutory appeal of an order or ruling mast be filed In writing within six days of notice of such ruling or order. 22.29 Besides stating the grounds for appeal, the moving party must demonstrate, to the appropriate Agency official, that: • The order or ruling involves Important legal or policy issues concerning which there is substantial grounds for difference of opinion; and aompit ance/ Barorceaent 7-90 Qnidgn^ fttnnai 1983 ------- Chapter Seven __ Hearing Stage • Immediate appeal will materially advance the proceeding or that waiting for normal review will be ineffective or inadequate. 22.29(b) The motion must also comply with requirements for filing, service, and content requirements specified in the CROP. If the Presiding Officer does not certify the interlocutory appeal, a party may make a motion to the Administrator within six days of service to reverse that decision on the grounds that It is contrary to the public interest.. Ibis motion must also, comply with the requirements of Section 22.16 and 22.05 of the CROP, except that the appropriate Agency officials receiving the motion are the Regional Hearing Clerk and the Administrator. 22.29(c) Actions by the If the Presiding Officer certifies the Interlocutory appeal, the : Administrator may? 22.29lte '«tay. TS. the "Presiding Officer grants a request for stay of over 30 days, it must be separately approved by the Administrator. 22.29(d) fYiapllimrr/Fnfnrrrmrnt 7-91 ------- Chapter Seven Exhibit 7-4 Sample Default Order UNITED STATES ENVIRONMENTAL PROTECTION AGENCY REGION III 6TH AND WALNUT STREETS PHILADELPHIA, PENNSYLVANIA 19106 In re: W.G. Neudecker and Sons 1215 Madison Avenue, N.E. Washington, D.C. 20019 Respondent Preliminary Statement I.F.&R. Docket No. III-54C DEFAULT ORDER This civil proceeding for the assessment of a penalty was Initiated pursuant to Section 14(a) of the Federal Insecticide, Fungicide, and Rodentlclde Act, as amended, 7 U.S.C. 5136 et seq., (hereinafter referred to as FIFRA) charging that the unregistered pesticide, "Adclde for Algae Control," was shipped from Washington, D.C., to Rockvllle, Maryland, on September 11, 1982, In violation of Section 12(a)(l)(A) of FIFRA [7 U.S.C. Sl36j(a)(l)(A)]. It Is hereby determined that an appro- priate default order shall be Issued based on the findings of fact and conclusions of law as set forth below. Findings of Fact 1. Two cases, each bearing four one-gallon bottles of the product, "Adclde for Algae Control," were shipped by W.G. Neudecker and Sons (respondent) from 1215 Madison Avenue, N.E., Washington, D.C., to Water Way In., 5544 Sycamore Lane, Rockvllle, Maryland, on or about September 11, 1982 (Shipping Order No. 45643). A sample from said shipment was obtained subsequently by representatives of the Environmental Protection Agency (EPA), Region III. 2. At the time of said shipment, the product sample bore a label that It was Intended for the prevention of algae and slime. 3. At the time of the said shipment, said product was not registered as a pesticide with EPA. 4. On July 16, 1983, the Enforcement Division, EPA, Region III (the complainant), issued a complaint and notice of opportunity for hearing to respondent, pursuant to Section 14(a) of FIFRA [7 U.S.C. i!361(a)], alleging that respondent had violated Section 12(a)(l)(A) of FIFRA by shipping an unregistered pesticide in Interstate commerce [7 U.S.C. f136j(a)(l)(A)J. (A copy of the complaint is annexed hereto as Attachment A.) 7-92 Guidance Manual 1983 ------- Chapter Seven Exhibit 7-4 .'\ 5. In the complaint, a civil penalty of$2,300 was proposed against respondent. Said penalty was proposed on the basis of its appropriate- ness to the size of respondent's business, the effect on respondent's ability to stay In business, and the gravity of the violation as calcu- lated by reference to the EPA "Guidelines for the Assessment Section 14(a); Citation Charges for Violations" [39 Fed. Beg. 27711 (1974)]. For purposes of assessing said penalty, respondent's gross annual sales were determined to be between $200,000 and$1 million during the previous year. Based on prior information communicated to complainant by the president of .respondent, respondent was considered to have had knowledge t>f the registration requirement. Accordingly, the proposed penalty was assessed at $2,300. Furthermore, based on a comparison of respondent's gross annual sales with the amount of the proposed penalty, it was determined that said penalty would have no substantial effect on respondent's ability to continue in business. 6. The complaint in the Instant case set forth respondent's right to request a hearing within twenty (20) days of receipt of the complaint, the retpjlrcaent of a written answer to the complaint, and .the conse- quences of failure to answer the complaint. Furthermore, a copy of the Consolidated Rules of Practice (CROP), 40 C.F.R. §22.01 et seq., was enclosed with the complaint. 7. Said complaint was mailed to respondent on July 16, 1983, via certified mall. Receipt No. 202684 was returned to complainant, stamped July 17, 1983, and bearing the signature "Betty Wilson" as signer for the addressee. (Copy enclosed as Attachment B.) 8. As of this date, respondent has failed either to respond to the complaint, request a formal hearing, or file an answer to the complaint naranant to .the CROP. Conclusions of Law 1. At the time of above shipment, said product was a pesticide within the meaning of Section 2(u) of FIFRA by virtue of its label claim of use ijT*^ *m fmm+ »<>Wn Thr •••n1nu. of "St Llluu 'J(lJ :of TZERA* [7 i -fS 13*(n), 2* By reason of the facts as set out In the findings of fact, respondent violated Section 12(a)(l)(A) of FIFRA by shipping an unregistered pesti- cide In interstate commerce. [7 U.S.C. f 136j(a)(l)(A)] 3. By falling to ,file ,a. tiaeljr •-, an ever -to ,<£he, ccauvlaint and to request a -<*••••** :frn«Ti-ng, TMpoadant 3a« '•«%«**••* the £aets alleged In the com- plaint and has waived its right to a hearing. Accordingly, respondent is In default and the proposed civil penalty is therefore due and pay- able. [CROP, 40 C.F.R. S22.17J FIFRA Oaapliance/Bnforcement 7-93 Guidance Manual 1983 ------- Chapter Seven »»*»•*hit 7-4 4. It is further concluded that by reason of the facts as set out In paragraph five (5) of the findings of fact, the amount of the proposed penalty is appropriate pursuant to Section 14(a)(4) of FIFRA [7 U.S.C. Sl361(a)(4)] for the following reasons: a. The penalty is appropriate to the size of the business; b. The size of the penalty would have no significant effect on respondent's ability to continue in business; and c. The violation involves the extremely grave charge of Interstate shipment of an unregistered pesticide. Order Respondent shall within sixty (60) days of receipt of this default order pay by cashier's or certified check a civil penalty in the amount of two thousand three hundred dollars ($2,300) to the Treasurer, United States of America. Such remittance may be sent by messenger or certified mail to the Pesticides Hearing Clerk, U.S. Environmental Protection Agency, Region III, Curtis Building, 6th & Walnut Streets, Philadelphia, Pa. 19106. In the event of failure of respondent to make said payment within sixty (60) days of receipt of this default order, the matter shall be referred to the United States Attorney for the District of Columbia pursuant to Section lA(a)(5) of FIFRA [7 U.S.C. Sl361(a)(5)] for recovery by appropriate action in United States District Court. AND NOW, THIS DAT OF October 4, 1983 the foregoing order is hereby issued under the authority of the Federal Insecticide, Fungicide, and Bodenti- cide Act, as amended, and the Consolidated Rules of Practice adopted pursuant thereto. [7 U.S.C. Sl361(a)(l)-(4); 40 C.F.R. J22.01 et seq.] Regional Administrator FIFRA Coaplisnce/Baforceseat 7-94 Qn±4fn*** gasaal 1933 ------- Chapter Seven Exhibit 7-5 Model Consent Agreement and Final Order Environmental Protection Agency In re: W.6. Neudecker and Sons 1215 Madison Avenue, N.E., Washington, D.C. 20019 Respondent I.F.&R. Docket No. III-54C CONSENT AGREEMENT AND FINAL ORDER Preliminary Statement 1. This civil proceeding for the assessment of a penalty was initiated pursuant to Section 14(a) of the Federal Insecticide, Fungicide, and Rodffnficide Act,, as artPTidfrU [7 P.S-C. J136 et seq. (hereinafter FIFRA). ] The action was Instituted by a complaint and notice of opportunity for hearing, filed upon respondent pursuant to FIFRA, charging violations of (cite specific sections of the Act) 2. Respondent filed an answer admitting the Jurlsdictional allegations of the complaint, admits (facts admitted) , and explains (neither admits nor denies) (facts explained) . 3. Respondent hereby explicitly waives the right to request a hearing on any issue consented to herein. 4, leapo consents to the Issuance of the order hereinafter recited, with the stipulations and admission of facts and conclusions of law for the purposes of this proceeding only. Respondent consents to the payment of a civil penalty of the amount set out in the order. Findings of Fact [The "Findings of Fact" section shall state with particularity -respect t"< Conclusions of Law By reason of the facts set forth in the "Findings of Fact," it is concluded that respondent Jus «l------- Chapter Seven Exhibit 7-5 Order Respondent shall within sixty (60) days of receipt of this consent agreement and final order, pay by cashier's or certified check a civil penalty In the amount of ($)_ dollars, payable to the Treasurer United States of America. Such payment shall be remitted to the Hearing Clerk, EPA Region , (address) . Failure to remit such payment will result In the referral of this matter to the United States Attorney General for collection pursuant to Section 14(a)(5) of FIFRA, as amended. [Alternative Order] Based on a finding that the payment of any or all of the penalty herein- before addressed would materially affect respondent's ability to continue In business, respondent, having duly stipulated to the violations as charged, is excused from payment in accordance with the terms of Section 14(a)(4) of FIFRA, as amended. (Signature of respondent) (Signature of complainant) Date: At: It is so ordered. This order shall become effective Immediately. (Signature of Regional Administrator) Regional Administrator, EPA Region (Title) EPA Region Date: At: FIFRA CoHpliance/Enfott 7-96 f+ Itmimal 1983 ------- Chapter Seven 6 Post-Hearing Stage Appeal of Initial Decision Jurisdiction of The Administrator assumes full jurisdiction of the case immediately after the Presiding Officer issues an initial decision. The Administrator assumes jurisdiction regardless of whether or not a party appeals the Initial decision. If, however, a party files a motion to reopen a hearing, the Presiding Officer may rule on that motion. 22.27(c) Once the initial decision is issued, the Regional Hearing Clerk's File, which now Includes the original initial decision, is forwarded to the Hearing Clerk. Consequently, the appellant must send any notice of appeal and accompanying appellate brief to the, Bearing Clerk. A .motion to reopen ag* however, is to 22.27(a), 22.30(a) Notice of Appeal and Appellate Brief The notice of appeal and appellate brief must comply with the general filing, service, and form requirements of the CROP where appropriate. The . fM*fr-f•£* ,cQ£ ^pp»-f1 .anA tit* -.appellate -ttTtff ^****" •-**»' -f41»ti:*ri1'*t -yh» goa-iHttg 22.30(a)(D The notice of appeal must address the disputed findings of fact and conclusions of law contained in the Initial decision. Specifically, it •ust contain: Jf fact; • Alternative conclusions regarding issues of law or discretion; • A proposed order that reflects the conclusions and findings desired by the appellant; and FOKA. GMpllance/&iforceme&t 7-97 ftHd^t*^ Manual 1983 ------- Chapter Seven Poat-H«»«"-1pg Stage • Relevant references to the record and the Initial decision. 22.30(a)(l) The appellate brief is intended to present the appellant's arguments as to why the appeal should be granted. AB such, it must include: • A statement of issues presented for review; • A statement of the nature of the case; • Identification of the facts that are relevant to the issues presented for review; • Specific arguments on the issues presented; • A short conclusion that includes the precise relief being sought; and • Appropriate references to the record and the initial decision. Party's Reply Any other party or amicus curiae may file a reply brief with the Hearing Clerk within 15 days of service of a notice of appeal and appellate brief. The reply brief is specifically intended to address only the appellate brief and should be so limited. Therefore* it should respond to the argument raised by the appellant, together with references to the relevant portions of the record, initial decision, or appellate brief. The reply brief must also comply with service, filing, and content requirements specified by the CROP. 22.30(a)(2) AdnyftHstrator *s Actions Even if the initial decision is not formally appealed, the Administrator may determine sua sponte that a review of the initial decision is necessary. The Administrator, however, has only 45 days after service of the Initial decision to review the initial decision sua sponte. Otherwise, the initial decision of the Presiding Officer becomes the final order of the Administrator. 22.27(c), 22.30(b) If the Administrator determines to review the initial decision sua sponte, the Hearing Clerk shall serve notice of such Intention upon the parties. The notice will include a statement of issues to be briefed by the parties and a time schedule for the service and filing of briefs. 22.30(b) uompJJLance/Enzorcement 7-70 Guidance fiaimai 1983 ------- Chapter Seven Post-Bearing Stage Scope of Review The appeal of the Initial decision must concern only those issues raised by the parties in the previous proceeding. 22.30(c) Oral Argument on Appeal Oral argument on appeal is not automatic and may be granted only if a party makes a request to the Administrator or the Administrator orders it sua sponte. In assigning a time and place for oral argument, the Administrator must consider, the convenience of the parties. There are no standards specified in the CROP for deciding whether oral argument should be heard. 22.30(4) .Final Order Timing and Content The Administrator is required to issue a final order as soon as is practicable after the final action of the appeal process—either after filing of appellate briefs, filing of subsequent briefs if ordered by the Administrator, or oral argument, whichever occurs last. 22.31 The Administrator may, in the final order: • Adopt, modify, or .-*et aside all or maae of the .findings mad conclusions contained in the initial decision or order; and • Increase or decrease the recommended penalty unless the initial decision is a default order (in which case the Administrator may not Increase the recommended penalty). The CROP requires the final order to contain the reasons for any decision Motion To Reconsider and Stay Request A party may file a motion to reconsider a final order within 10 days after service of the final order. A motion to reconsider must set forth the matters claimed to have been erroneously decided and the nature of the Ihe mot Ian may Jilso 1-nclndr.« raqiaiT £hat the final order Tending a resolution of the motion to reconsider, unless such a request for stay is granted, however, the effective date of the final order is the date on which it was issued, unless otherwise ordered by the Administrator. 22.32 rnmpiinnrr/rrnrnrrrmcnt 7-9y fSn4Am^t*f Msmrii 1983 ------- Chapter Seven Post-Bearing Stage Appeal From Final Order A party may appeal the findings of the final order to a United States court of appeals pursuant to the provisions of Section 16(b) of FIFRA. The obligation to pay the civil penalty does not become due until the party has exhausted all appeals* Notice of Judgment Upon signature of the final order by the Regional Administrator, the case will be closed and a notice of judgment prepared and sent to Headquarters for publication in accordance with the requirements under Section 16(d) of the Act. (See Appendix 2, Notices of Judgment.) Payment of Penalty The payment of the civil penalty specified in a final order of the Administrator is due and payable in full within 60 days after the respondent receives the final order, unless otherwise agreed by the parties. 22.31(b) FXFK& coap n mice/ anxorceaeat 7-iOO Goloamce Banna 8 1983 ------- Chapter Eight Judicial Enforcement: Civil Actions Chapter Contents Page 1 Introduction 8-1 2 Elements of a Violation; Civil 8-3 Evidence in Support of Civil Actions 8-3 Use of Expert Witnesses 8-4 3 Procedures for Filing Actions 8-5 JErhibit 8-T: Itodel Civil Litigatitm leport Outline and Guide 8-8 4 Injunctive Actions 8-17 Statutory Authority 8-17 Justification for Seeking Injunctive Belief 8-17 Procedures for .Seeking .Injunctive ..Belief 8-18 Exhibit 8-2: Model Motion for Temporary Restraining Order 8-22 Exhibit 8-3: Model Motion for Preliminary Injunction 8-23 Exhibit 8-4: Model Affidavit in Support of Motion for Preliminary Injunction 8-24 "Mnrif 1 -itotion jfor • *£t£Btucstt Injunction 8-25 inmp11 •nrr/rnrnrrrm or o—i "«'<'ir^ir* namiii 1983 ------- Chapter Eight Contents 5 In Rem (Seizure) Actions 8-27 Statutory Authority 8-27 Enforcement Criteria 8-27 JLn Rem Procedures 8-28 Compliance With a Seizure 8-29 Disposition of a Seizure 8-29 Exhibit 8-6: Model Complaint In Rem 8-31 Exhibit 8-7: Model Report of Supervision of Disposition 8-34 Exhibit 8-8: Model Expenditure Report Form 8-35 6 Settlement Agreements 8-37 Goflpliance/Enforceaent8-iiGuidance Manual 1983 ------- Chapter Eight 1 Introduction Under FIFRA, regulatory remedies are Initially and primarily handled . through the .use of administrative actions. However, in tho«e Instances vbere EPA ,±« unable to obtain compliance with administrative actions, the Act authorizes EPA to seek relief through civil court injunctive and in rem (seizure) proceedings. An injunction is a writ Issued by a court forbidding or commanding a person to perform a particular act. Injunctions Involve the equity powers of Federal courts and are generally viewed as an extraordinary form of relief. Consequently, they are not readily granted and a party seeking injunctive relief has a heavy burden in demonstrating the need for such action. In rem (seizure) proceedings signify «"•«•* gffa*""* *"hingj xather than Iniilyldiails*. Therefore, a proceeding "in rcn" Is one taken against property and has for its object the disposition of the property. mapninrrjimrnrrraf nr o-i Guidance Iff1"**' 1983 ------- Chapter Eight Introduction FIFSA Gcmpliance/Eaforce*ent 8-2 g^fd*"*^ Manual 1983 ------- Chapter Eight 2 Elements of a Violation: Civil Evidence In Support of Civil Actions Civil actions require supportive evidence that goes beyond the prima facie evidence necessary to establish administrative violations of FIFRA. In some Instances, this may require the use of expert witnesses to establish certain elements of proof (e.g., immediate and irreparable injury). Below follows a list of additional evidentiary showings that should be met before undertaking an injunctive or in rem action. Injunctive Actions* h»»» *»qn*-r»d *K» -p^-n-in.™^ w plaintiff to make -the following showings before a permanent injunction would be issued: • There is an inadequate remedy at law; • The applicable administrative remedies have been exhausted; and • Irreparable injury, loss, or damage will result if the relief is Issuance of a preliminary Injunction or temporary restraining order would require the following additional showings: • Immediate and Irreparable Injury, loss, or damage will result if the relief is not granted; and * These actions may consist of permanent injunctions, preliminary injunctions, or temporary restraining orders. These types of injunctions are discussed in more detail in Section 4 of this chapter. 8-3 ------- Chapter Eight Elements of a Violation; Civil • There is a likelihood of success at trial, based on facts before the court. The above criteria are not, however, uniformly applied by the various judicial districts. While some jurisdictions emphasize different aspects of the criteria, other courts have developed alternative tests that use some, but not all, of the elements listed above. For this reason, an attorney considering this type of civil action should research recent trends in the jurisdiction in which the Injunction is being sought. In Rem (Seizure) Actions For a pesticide or pestlcidal device, the Act specifies that the following jurlsdictional conditions be met before initiating an In rem (seizure) proceeding: • The pesticide or device is found and seized within the jurisdiction of the district court that will hear the action; and • The pesticide or device is being transported or, having been transported, remains unsold or in original unbroken packages; or • The pesticide or device is sold or offered for sale in any State; or • The pesticide or device is imported from a foreign country. Use of Expert Witnesses As in the case of administrative actions, civil judicial enforcement proceedings generally require the presentation of expert testimony by EPA personnel appearing as witnesses. Such testimony is used to establish certain elements of proof that justify the relief sought (e.g., the showing of inmediate and irreparable Injury for obtaining an injunction). Witnesses should be selected for their direct knowledge of the circumstances surrounding the suspected violation, because the witnesses will be required to relate any such knowledge to the court. (See Appendix . 5, "Expert Witnesses.") FIFRA Compliance/Enxor ------- Chapter Eight 3 Procedures for Filing Actions Bequests for FIFBA civil court actions are referred to the Department of Justice or *he appropriate Bolted States (Attorneys Off ice by .the Associate Administrator f or OtEC (or the Associate Administrator's designee) .* In oos t instances, the Regional Office will initiate the request for an Injunction or an In rem action and will designate the lead Agency attorney.** The lead attorney is responsible for preparing the "referral package," which, upon completion, is sent from the Regional Office to OLEC. A copy of the package should also be forwarded to PTSCMS. A referral package contains : • Referral Memorandum* A referral memorandum identifies the primary elements of the proposed litigation. Specifically, the memorandum, ft A- Jt - Identification of the potential defendants; - Brief factual summary of the case; - Identification of the major issues (including potential problems that may exist with the case); The Regional Office has Independent authority to refer requests for emergency temporary restraining orders under FIFRA to the Department of Justice and the appropriate United States Attorneys Office. Vhen exercising this authority, however, the Regional Administrator wist notify the Associate Administrator for OLEC and the Assistant Administrator for Pesticides and Toxic Substances (or their designees.). Headquarters -program and "Enforcement Counsel staff may participate more actively in the case development process if precedential or nationally significant Issues are involved. 8-5 ------- Chapter Eight Procedures for Filing Actions - Status of past Agency enforcement efforts; and - Names of Agency and Department of Justice attorneys who are involved in the case, including the lead attorney. • Civil Litigation Report. In addition to the referral memorandum, the referral package must contain a litigation report, prepared by the designated lead EPA attorney. (For a complete outline and guide to preparing the report, see Exhibit 8-1•) The report must Include a synopsis of the facts and history of the violation, including past violations by the potential defendant. The report must cite the specific sections of FIFRA and its regulations that have been violated. The report must show that all elements of the violation have been satisfied. For each element, the report should indicate the available supporting evidence. A copy of the necessary documentary evidence and summary of the expected expert testimony should be attached to the litigation report. The lead attorney should include a statement regarding the specific relief to be sought (e.g., injunctive or in rent action). The report should also include a list of any equities that may weigh against granting the relief sought by EPA; any expected defenses by the violator (and how they will be countered); and any past, anticipated, or pending State or Federal actions (administrative or judicial) against the violator. Where an injunction is requested, the report should discuss the likelihood that the violator would comply without the Imposition of an injunction. Once the referral package is received by Headquarters, Enforcement Counsel attorneys will conduct a limited final legal review to ensure completeness and consistency in application of enforcement policy. The ease will then be transmitted to the Department of Justice or the appropriate United States Attorneys Office. OLEC will notify the Regional Administrator and the Assistant Administrator for Pesticides and Toxic Substances (or their deslgnees) upon the transmittal of the civil referral. Following the referral of a case, the lead EPA attorney will be responsible for coordinating responses to all requests for supplemental information by the Department of Justice or the United States Attorneys Office. The lead Agency attorney also will be responsible for keeping program officials and other previously Involved Agency attorneys apprised of case developments after referral. Agency employees who are Involved in the Investigation and referral to the Department of Justice of civil FIFRA actions should familiarize themselves with the Agency documents listed below. These documents are contained In EPA's General Enforcement Policy Compendium. • Memorandum of Understanding Between the Department of Justice and the Environmental Protection Agency (6/15/77); PUKKA Uottpliance/Enforceaent 8-6 Onldmc* MMMMLL ------- Chapter Eight Procedures for Filing Actions • Quantico Guidelines for Enforcement Litigation (4/8/82); • General Operating Procedures for EPA's Civil Enforcement Program (7/6/82); and • Case Referrals for Civil Litigation (9/7/82). FIFEA GMpllance/Bnforceaent 8-7 Guidance Manual 1983 ------- Chapter Eight Exhibit 8-1 Model Civil Litigation Report Outline and Guide* Title Page A. Identify the facility by name and location and indicate the parent company if different from the facility name. B. Identify who prepared the report (both legal and technical personnel) indicating addresses and telephone numbers. C. Show the date of completion/submission of the report. Table of Contents (Standardized Example) I. Information Identifying the Defendant(s) Page II. Synopsis of the Case Page III. Statutory Authority Page IV. Description of Defendant's Business and Technical Description of the Pollution Source Page A. Facility Description Page B. Source of Pollution Page C. Pollutants Involved; Environmental Harm (Where Appropriate) Page D. Available Control Technology and/or Bemedial Action Page The Model Civil Litigation Report Outline and Guide Is to be used for all Agency civil referrals to the Department of Justice* Civil litigation reports, however, are most frequently used In referring civil court actions under statutes other than FIFBA. Therefore, certain sections of the report would not need to be as detailed as those prepared for referrals involving non-FIFRA violations. For example, since FIFRA referrals Involve only requests for injunctive or in rem relief, civil penalties would not need to be discussed In Section VII of the report (Relief Requested). FIFBA O>*»|t1 •! tmfp/'Btnftprfaffxftf &~S &** tfms^ff* ftetMial 1983 ------- Chapter Eight Exhibit 8-1 V. Administrative and Enforcement History Page VI. Required Elements of Proof and Evidence Page A. Elements of Proof Page B. Evidence of Violation Page C. Evidence of Environmental Barm (Where : Appropriate ) Page D. Discovery Page E. Evidence Favorable to Violator Page F. Government Witnesses Page 6. Defense Witnesses Page H. Resource Needs Page VII. Relief Requested Page A. Preliminary Injunction Page B. Standards To Be Met Page C. Compliance Schedule Page D. Stipulated Contempt Fines Page ^E. -"'""Civil Penalties Page F. Necessary Bonds Page VIII. Anticipated Issues Page A. Possible Defenses Page C. Pending Related Administrative or Court Action Page D* Other Issues Page E. Discussion of Any Potential Practical ... Problem With Che. Case ..--•. ;fbge IX. Litigation Strategy Page A. Need for Preliminary Injunction Page FIFBA 1\mp1 1 imrr/TTnf orccacnt 8-9 ort«i^m»g MM^I 1983 ------- Chapter Eight Exhibit 8-1 B. Potential for Summary Judgment Page C. Settlement Potential Page D. Other Potential Defendants Page X. Index of Attachments Page XI. Attachments Page • Copies of correspondence • Copies of relevant regulated submissions • Copies of relevant policy memo8, regulations, interpretations Body of the Report I. Information Identifying the Defendant(s) A. Legal name of company B. Address: Corporate headquarters C. Name of facility (if different from "A") D. Address of facility (if different from "B") E. SIC code F. State of incorporation 6. Registered agent for service H. Legal counsel (name, address, telephone number) I. Judicial district in which violator is located II. Synopsis of the Case This section should be a one-or two-page articulation of the heart of the case. It should describe both the violation and the proposed relief. It should not describe statutory authority or intricate legal issues in detail. This succinct statement of the case will provide the reader a framework In which to fit the details developed and presented in the body of the litigation report. FIFRA GMTO!lance/Hnf/vivomoT^ a_in ------- Chapter Eight Exhibit 8-1 The factual basis of the case should be touched upon. Purely conclusory characterization of the case is not as useful as showing the facts of a violation and requested relief. For example, it Is better to say a violator discharged or emitted X quantity of T pollutant for Z days, than to simply say that the violator did not comply with the terms of a permit, State Imple- mentation Plan (SIP), or statute. The environmental seriousness of the violation, its ongoing nature, and a viola tor'a -recalcitrance may be touched upon in this section (but -sill also be developed later in paragraph III. Statutory Authority A. Present the substantive requirements of the lav and applicable regulations. Beference all federal statutes by U.S.C* citation as veil ^ as by the section of the pertinent Act. Summarize the enforcement authority, jurisdiction, and venue. Specific elements of proof are to be addressed in paragraph VI. B. Lengthy dissertation on the law is unnecessary. However, in the instance of State Implementation Plans under the Clean Air Act, or Water Quality Standards under the Clean Water Act, or Involvement of any other state law or regulation, a more extensive explanation of the law or regulation may be necessary. Pertinent excerpts from any applicable state laws or regulations should be identified and attached to the litigation report. C. Any prior Interpretation of pertinent state laws or regulations which are germane to the case should be referenced when identifying the law violated. If a state's interpretation of the law has been different from ours, the Issue should be discussed with the state and fully explained In this section of the litigation report. (This section may then be referenced when discussing potential defenses, etc., • • - 111 m m m I I • I Mil ' TH 11 ' -\ - ..-331 .jySil •|ftl ffa. WAt tm) D. List any other possible theories of violation under federal, state, or common law. IV. Description of the Defendant's Business and Technical Description of the Pollution A. Describe the violating corporation and the particular division or facility in question. Any interesting corporate Interrelationships or subsidiaries should be noted. FIF1A GbHpUance/Bfeforeemeat 8-11 ^•'IJOTCP Manual 1983 ------- Chapter Eight Exhibit 8-1 B. Discuss the business of the corporation and/or division, providing details about the facility in question, what is produced, and what causes the pollution. Emphasis should be on the particular process that is causing the problem. Plant and process should be thoroughly explained, including those outfalls or emission points not subject to this enforcement action. Diagrams should be referenced and attached to, or included in, the litigation report. Photographs of the source may be helpful. C. Discuss the types of pollutants being discharged, and potential health and environmental effects. Although the seriousness of the violation is not technically a requirement of proof in enforcement of certain statutes, it is sometimes relevant to the assessment of penalties and equitable relief. For this reason, it should be discussed in the report although it will not be the sole determinant of whether a case has prosecutorial merit. The Department of Justice has suggested the following considerations in assessing the seriousness of the violation: • The discharge of toxics or mutagens or carcinogens is more serious than the discharge of conventional pollutants; • The discharge of large quantities of pollutants is more important than the discharge of small quantities; • Bioaccumulative wastes posing long-term threats are more serious than biodegradable wastes; • The discharge of pollutants in an area not attaining primary ambient air quality standards is more important than discharges in an area not meeting secondary standards; • The discharge of pollutants that directly and demonstrably affect health or the environment is more than those that have no direct or obvious effect; • Ongoing present violations that the Government seeks to stop are more important than episodic violations which have ceased; and • A defendant with a history of violations Is more worthy of attention than a first offender. If a case does not present obvious "serious" health effects or environmental harm, but is compelling for some other reason (e.g., deterrence of continued, blatant violations of the law), this should be Indicated. TTFRA ffrmnl < anr* /ttnfn-ri-^mfi nf Q-T7 _on* «l------- Chapter Eight Exhibit 8-1 D. Discuss available methods of controlling the problem. Specify technology(s) that will achieve the imposed limits, and indicate the time requirements for a schedule of compliance which considers time necessary for design, contracting, construction, and startup. (This is not inconsistent with EPA policy of not prescribing specific compliance technologies. This information may be necessary in court to illustrate technical feasibility if requested by the judge.) Cost estimates should be included, to the extent known. Indicate the reliability of the estimates. (Reference paragraph VII(E) as appropriate.) V. Chronological Administrative History and/or Earlier Enforcement Actions (State and Federal) A- Show all attempts - to exact compliance or . iapose sanctions administratively or judicially that have been considered or taken. A full historical chronology should be presented. B. Indicate whether necessary notice pursuant to the statutory requirements has been given to the violator prior to initiation of court action. VI. Required Elements of Proof and Evidence A. List the necessary elements of proof to establish the B. Present a detailed, objective, factual analysis of all real, documentary, and testimonial evidence corresponding to each necessary element of proof in paragraph VI(A) above. Indicate the location of all real evidence. Reference each item of documentary evidence as an attachment, •- ••. -**GMKp£-.---*l>Bre';Jit Isvt&o >?volnBlaDas -Clsi which case indicate Its present location) . Identify all witnesses by name (indicating whether lay or expert), when Indicating the Import and substance of their testimony. Complete addresses and phone numbers of witnesses will be listed in paragraph VII(E) below. •vallable fcy dis covery, indicate: 1. The type of evidence anticipated; FIFRA Cbapllance/Knforceaent 8-13 Guidance Manual 1983 ------- Chapter Eight Exhibit 8-1 2. The person or organization currently having the evidence; and 3. The type of discovery to be used. Assess the quality of the evidence. Be objective. Any facts or circumstances that affect the strength of the Agency's proof should be explicitly set forth. The newness or oldness of evidence is relevant; the dependability of testing techniques is Important. Any assumptions, and the reasons for them, should be spelled out. D. If establishing environmental harm is important to the case, set forth the evidence of harm (as done In paragraph VI(B) for elements of substantive violation). E. List all evidence favorable to the violator, Including test results that differ from EPA's. Any relevant fact that may bear adversely on the Government's contentions should be highlighted. Defense witnesses, to the extent they can be anticipated, should be listed in paragraph VI(6). F. List all government witnesses alphabetically with business address, and telephone number and home phone number. Quali- fications of experts should be given. All witnesses listed should have been consulted and thoroughly interviewed. Paragraph VI(B) should set out in succinct fashion the actual facts and opinions to be included in the testimony. G. List all defense witnesses anticipated, identifying their employment, expertise, etc. The likely content of their testimony should be set out in paragraph VI(E). H. Indicate projected resource needs (e.g., experts, money, etc.). VII. Relief Requested This paragraph should Include a comprehensive "bottom-line" settlement position on all items of relief necessary, including those set forth below. If there are policy questions or conflicts associated with any requested relief, discuss them. This section should be carefully detailed. It will be relied upon in determining the acceptability of any settlement offers/proposed consent decrees. A. Preliminary injunction. B. Standards to be met (interim and final). FIFRA Compliance/Enforcement 8-14 Guidance 1983 ------- Chapter Eight Exhibit 8-1 C. Compliance schedule for available technology with phasing, duration, etc. (Reference paragraph IV(D), as appropriate.) D. Stipulated contempt fines in conjunction with compliance schedule . E. Civil Penalties. 1. Economic savings realized by the violator should be analyzed. .The EPA Civil Penalty Evaluation form should be completed, discussed, and attached. Calculations should be included as attachments. This section should Include discussion of all elements developed under EPA's civil penalty policy, Including ability of the company to pay and recalcitrance. 2. Comment on types of credits possible (or proposed by the violator) , as veil as credits considered and/or allowed 'for othrr w*m1 1 *T •-•y* **] ffn-m ^•t-n^ivm^-^ittr -municipal POTHs). 3. If economic savings is not a relevant measure of penalty assessment, explain what basis should be used. F. Necessary bonds. Witnesses necessary to establish the relief requested should be identified by name, address and telephone number, with a brief summary of the subject of their testimony. KX11 A. Possible defenses. (Analyze only defenses that are likely to be presented; fanciful theories can be ignored.) 1. Outline legal issues. Attach legal memoranda on threshold legal Issues (e.g., Chapter 11 Reorganization) or col- ntlgatlon. 2. Outline factual Issues. B. Equitable arguments by the violator. -t« >tttd facilities; emission standard to be revised; inability to finance; economic constraints, etc.) FIFKA Gnapliance/bforcement: 8-15 &»------- Chapter Eight Exhibit 8-1 Any past action, or inaction, (not necessarily judicial or administrative) by a state or any EPA office that the company may use as an excuse, or cite for reliance, (e.g., promises of less stringent limits; agreement not to sue, etc.). C. Pendency of any action involving the violator or EPA on related Issues in any court or administrative forum. (Reference paragraph V(A), as necessary.) D. Other possible issues that might arise at trial. E. Discuss any potential practical problems with the case. IX. Litigation Strategy A. Need for preliminary injunction. B. Potential for summary Judgment. C. Settlement potential. 1. Past contacts by EPA, the Department of Justice or the United States Attorneys Office. 2. Present negotiating posture and assessment of potential for settlement. Include comparison of posture with "bottom-line" settlement position from paragraph VII. D. Other potential defendants. E. Other pending actions against violator. X. Index of Attachments XI. Attachments FXPSA Gaapllsaee/Eoforeeaent 8-16 Guidance Manual 1983 ------- Chapter Eight 4 Injunctive Actions Statutory Authority EPA has the authority to initiate injunctive actions under Section 16(c) of FIFRA, which states that the "district courts of the United States are vested with jurisdiction specifically to enforce, and to prevent and restrain violations of this Act." Justification for Seeking Injunctive Relief 3he cour£« ^re %f^aexmlly .reluc^mt ^> iMue ^mandatory injunctions or 'to issue injunctions that will alter the status quo except in the most compelling instances. Consequently, the Agency's need for injunctive relief should be clear and unmistakable. A permanent injunction should be considered when: • The Agency's administrative or other judicial enforcement remedies would be inadequate either at restraining the violation or at - . - |.T»MIH-*IIB TmrrmTTrrmtflT Ttf*" tr Jimrnr rrr "fhr ------- Chapter Eight Injonctive Actions A preliminary injunction or temporary restraining order should be considered when the following additional elements are present: • Immediate and irreparable injury, loss, or damage will result if relief is not granted. "Immediate" is self-explanatory and is interpreted strictly; and • There is likelihood of success at trial based on facts before the court (i.e., more than a 50 percent chance of winning at a trial based on facts before the court at the time of application). Modern court trends have been to relax the requirement of irreparable injury. In particular, where a statute prohibits certain conduct, many courts will presume the conduct to be injurious thus warranting an injunction without requiring a showing of irreparable Injury. Ibis doctrine has been applied to violations of the Federal Food, Drug, and Cosmetics Act [U.S. v. Dlapulse Corp. of America, 457 F.2d 25 (2nd Cir. 1972)]. It Is reasonable to expect that the doctrine can be extended to apply to violations of FIFBA. For instance, where there is a real possibility of an "imminent hazard" to human health or the environment, irreparable injury may not need to be shown. Conditions That May Justify Injunctlve Relief Injunctlve relief may be justified when: • There is a violation of a Section 6 suspension order; • There is a violation of an SSURO, where a civil penalty or criminal prosecution would not provide a timely and effective enforcement remedy to deter further violations; • There is continued production, shipment, sale, or use of an unregistered pesticide after the Agency has taken civil or criminal action; or • The Agency has exercised an enforcement remedy and a person continues to make available for use a restricted use pesticide other than In accordance with Section 3(d), or continues to use a pesticide in a manner Inconsistent with its labeling or in a manner contrary to an experimental use permit. Procedures for Seeking Injunctive Relief 1. Determine the Necessity for Injunctlve Relief • Regional Initiation. The Regions generally make the initial determination that an injunction is necessary to restrain Compliance/mxorGement 8-18 Guidance **?**"•' 19B3 ------- Chapter Eight Injunctive Actions violations of FIFRA or to prevent harm to humans and the environ- ment. The regional determination must be based on a careful weigh- ing of the facts of the violation, of the evidence available to document the severity of the violation, and of the justifications discussed above. • Headquarters Initiation. In some instances, Headquarters may be the initiating party when noncompliance with the terms of the statute exists on a national level or the Registration Division has alerted PTSCMS to a situation that warrants an injunction. Determine Type of Injunction To Be Sought • Temporary Restraining Order (Exhibit 8-2). A temporary restraining order (TRO), sometimes known as a provisional injunction, is limited and will expire In 10 days (but can be extended an addi- tional 10 days by the court). It Is used when it can be shown by affidavit *vr'^T*'f*|»d*'re"p1 r*"* «•*«»*• -foj»»«i-t««-» and Irreparable Injury, loss, or damage will occur before the time that the adverse party can present its case. The purpose of the TRO is to preserve the status quo until a motion for a preliminary injunction can be heard. Its advantage is that it is the most expediently obtained form of injunctive relief. Rule 65(b) of the Federal Rules of Civil Procedure (Fed. R. Civ. P.) controls the procedural steps for obtaining a TRO. Generally the attorney for the adverse party, if known (or if not known, the adverse party itself), must be given oral or written notice of the request for a TRO. However, this requirement is suspended if (1) . .It jiB shown hy SIM*pi fie facts that lawedl&te .•and 1 rrf iMirshlf harm ^•111 occsir «befor« the adverse party can :be iaeard and (2) If the government attorney certifies in writing the efforts, if any, taken to provide notice to the adverse party and the reasons supporting the claim that notice should not be required. The facts demonstrating immediate and/or irreparable injury, loss, or damage, may appear either in a verified complaint or in a separate affidavit signed by an EPA employee other than the attorney for the case. Along with the motion for a TRO, a copy of the suggested TRO should ------- Chapter Eight Injunctive Actions • Preliminary Injunction (Exhibit 8-3). A preliminary injunction by its very nature is interlocutory, provisional, or temporary. It is intended to preserve the status quo pending final determination of the action after a full hearing on the merits. It is different from a TRO in that a preliminary injunction requires advance notice to the adverse party, and it can last longer than 10 days. Notice presumes a hearing and an opportunity to contest the motion for an injunction. The applicant has the burden of establishing the right to injunctive relief. To do so, it is advisable to rely on more than affidavits (Exhibit 8-4) whenever possible. Oral testimony should be available when and if necessary to substantiate the Agency's contentions. At the hearing on the application for preliminary injunction, the court may order an advancement and the consolidation of the trial on the merits. Consequently, the government attorney should be prepared to go forward with the prosecution of the case when seeking a preliminary injunction. • Permanent Injunction (Exhibit 8-5). A permanent Injunction, also called a final or perpetual injunction, is generally unlimited in duration. It is usually granted only after a full trial on the merits. Consequently, the judgment granting a permanent injunction constitutes final disposition of the suit, although the judgment may be appealed to a circuit court. Mere passage of time will not dissolve a permanent injunction, unless the judgment itself so provides. However, the prospective features of a final injunctive decree are subject to termination or modification by the court when warranted by changed conditions. 3. Determine the Appropriate District Court Having Jurisdiction The Regional Office must determine which is the appropriate district court having Jurisdiction over the violator. An injunction operates In personam (meaning "against the particular person"), so that the dTstrict court in which the motion is filed must have in personam jurisdiction over the party against whom the injunction is sought. Usually this means that the person or corporation who Is the defendant must live or have a place of business within that State. Service of process, or the delivery of written notice, In a district court is subject to the territorial limits of the State in which the court is located. However, In some instances, an injunction may have an in rem ("against the world at large") effect on property or items that are the subject of the suit or that are within the court's in rem Jurisdiction, jn rem jurisdiction may have a broader reach for serving process than does in personam—it is easier to get "the thing" than it is "the person." These possibilities should be explored informally with the appropriate U.S. Attorney before formal referral of the case file. compliance/ mtor cr me at o-zu Guidance ------- Chapter Eight ____^_ Injunctive Actions 4. Prepare the Referral Package See discussion In "Procedures for Filing Actions" (Section 3) in this chapter. Court Actions on Motions for Injunctlve Relief If -an injunction is granted, the following actions should ensue: • Preparation for the Next Stage of the Proceeding. If the court grants a motion for a preliminary injunction or TRO, the regional attorney in conjunction with the U.S. Attorney must begin prepara- tion for the next stage in the proceeding, whether that be a full trial on the merits or a more extensive and permanent type of injunction. « Monitoring the Injunction. . Although It is the court * s jresponsibil- ity to monitor any equitable decree, including an injunction, the courts have limited resources and often encounter practical diffi- culties in monitoring compliance. If the court does not ask the Agency to monitor the injunction, the Region should offer to assist the court in monitoring the injunction and to report any violations of the injunction. A violation of an injunction will subject the party to a charge of contempt of court. If an injunction is denied, the Agency may either: • Appeal the denial; or -•-:-•-<• Accept the denial ^and pursue other legal remedies. In both Instances, the Headquarters Case Development Officer (HQCDO) should be consulted by the Regional Office to determine which course of action to take. compliance/Baxorceaent 8-21 Guidance •****•**»* 1983 ------- Chapter Eight Exhibit 8-2 Model Motion for Temporary Restraining Order United States District Court District of (Title of Action) Civil Action No. Motion for Temporary Restraining Order [With or Without Notice] Plaintiff, the United States of America, herewith moves this court to grant [*(!) forthwith and without notice to defendant for his attorney] a temporary restraining order restraining defendant, his agents, and employees from (set forth acts sought to be enjoined) pending a hearing and disposition of plaintiff's motion for a preliminary injunction on the grounds that immediate and irreparable loss, damage, or injury will result to (*(2) plaintiff, the public, the environment] as set forth in the attached verified complaint and affidavits of (name of affiant) [*(3) before notice can be given] and before defendant or his attorney can be heard in opposition [*(4) as appears more fully in the attached certificate of the undersigned showing that all reasonable effort has been made to notify the (defendant and/or his attorney) of this motion]< (Signature of U.S. Attorney) United States Attorney for the District of Date * (D»(3),(4) - These statements are optional depending upon whether or not the defendant or his attorney receives advance notice of the request for a TEX). * (2) - The victim of the alleged Injury can be best determined from the actual facts of the case at hand. FIPBA flH.jjp1 -Iamfei/'Ktfnff»sffitf 8—22 ------- Chapter Eight Exhibit 8-3 Model Motion for Preliminary Injunction United States District Court District of (Title of Action) Civil Action No. Motion for Preliminary Injunction Plaintiff moves the court for a preliminary Injunction enjoining the defendant (name of defendant), his agents, servants, employees, and attorneys and all persons in active concert and participation with him, pending the final hearing and determination of this action, from (set forth act or acts sought to be enjoined) on the grounds that: XI) Unless restrained by tfa±s *eonrt defendant will perform the acts referred to; (2) Such action by the defendant will result in immediate and irreparable injury, loss, or damage to (the plaintiff, the public interest, or the environment), as appears in the verified complaint and the affidavit of (name of affiant), attached hereto; and (3) The Issuance of a preliminary injunction herein will not cause undue inconvenience or loss to defendant, but will prevent an* ^T-apflT-aKlo -trvj.ii-y fn. fjjg plaintiff. (Signature of U.S. Attorney) Doited States Attorney for the j&strict of Date FUFKA Q»FPl •!»*»«• «*/RnfQT£^•^nt 8-23 Guidance n««m^i 1983 ------- Chapter Eight Exhibit 8-4 Model Affidavit in Support of Motion for Preliminary Injunction United States District Court District of (Title of Action) Civil Action No. Affidavit in Support of Motion for Preliminary Injunction (Hame of Affiant) , being duly sworn, deposes and says: (1) It [the United States] is the plaintiff in the above-entitled action; and that it makes this affidavit in support of plaintiff's motion for a preliminary injunction herein. (2) This is an action [to enjoin defendant from engaging in any violation of the Federal Insecticide, Fungicide, and Bodenticide Act, as amended, 7 U.S.C. 8136 et seq.]. (3) [Statement of facts to support the motion]. (Signature of Affiant) (ot gna her than EPA attorney) Subscribed and sworn to and before me at (City and State) this day of , 19 . (Signature of Attesting Official) Cot & than EPA attorney) /ftnfnTi 8-24 1983 ------- Chapter Eight Exhibit 8-5 Model Motion for Permanent Injunction United States District Court District of (Title of Action) Civil Action No. Motion for Permanent Injunction Plaintiff, the United States of America, herewith moves the court to make permanent the preliminary Injunction issued herein on (date). In support, plaintiff submits (the opinion of the court of )_ which is conclusive to the effect that the (behavior or activity"of the defendant) is unlawful and no additional evidence could alter that result. I optional: (I) Counsel may also want to Include a paragraph-moving the court to enter the mandate of a higher court, if the grant of injunction has been unsuccessfully appealed.] [optional: (2) Counsel may also find it necessary to include a motion either for the dismissal of defendant's counterclaim or for the grant of summary judgment as to the counterclaim.] (Signature of .U^.. -Attorney Jtaited States Attorney ,for the District of Date FIFRA Covpllance/Bnforcevent 8-25 Cn<^««rfi Manual 1983 ------- Chapter Eight ^XFMA uoapHanee/Enforcement 8-26 Galdance Manna1 1983 ------- Chapter Eight 5 In Rem (Seizure] Actions Statutory Authority Section 13(b) of FIFRA authorizes the seizure, through an in rem condemnation proceeding in district court, of: • Any pesticide that is adulterated, misbranded, unregistered, not colored or discolored as required, or bears claims or directions for use that differ from those made in connection with its registration; • Any pesticidal device that is misbranded; and -••--+ Any nestAclde or peytlcldal device *hat causes tmreastmable adverse effects upon the environment, even when used in accordance with the requirements imposed under the Act. Section 9(b) authorizes duly designated Agency employees to obtain and execute warrants for the purpose of seizing any pesticide or pesticidal device that is in violation of the Act. Enforcement Criteria Seizure of a pesticide or device is effectuated through an in rem condemnation proceeding conducted according to Rule 9(h) of the Federal Rules of Civil Procedure (Fed. R. Civ. PO and.the Supplementary Rules for Ilitle 2BU.S.C.]. 3he procedure to initiate this judicial action requires more preparation and time than that necessary to issue an SSURO. FIFRA Compliance/Enforcement 8-27 Guidance Manual 1983 ------- Chapter Eight In Bern Actions Therefore, the SSURO is the preferred remedy in terms of expediency. A seizure, nonetheless, should be considered when: • An SSURO has been issued and is not being complied with; • There is reason to believe that an SSURO, if Issued, would not be complied with; • A pesticide is so hazardous that it should be removed from the marketplace or its place of use; • It is necessary to support a recall; or • It is necessary to dispose of products that remain under an SSURO without corrective action and for which there is an expressed intent not to take corrective action by the person holding the violative product. In Rem Procedures 1. Prepare the Referral Package Upon determining that a pesticide or device is in violation of the Act and that a seizure is the appropriate level of enforcement action, the Regional Office should prepare a civil litigation referral package (see Section 3 of this chapter). The package may include a proposed complaint in rem (Exhibit 8-6), which is prepared in accordance with Rule C of the Supplemental Rules for Certain Admiralty and Maritime Claims that accompany the Fed. R. Civ. P. The necessary elements of the complaint in rem are that: • It be verified by oath or affirmation; • It describe with reasonable particularity the property that is the subject of the action; « It state that the property to be seized is (or will be during the pendency of the action) within the jurisdiction of the district court that will hear the action; • It state the place of seizure; and • It state the allegations of the violations, as required by the statute, with sufficient particularity that the defendant/ respondent can frame responsive pleadings and investigate the facts without moving for a more definite statement. FIF1A GoBpliance/Enforceaent 8-28 Guidance Manual 1983 ------- Chapter Eight In Eat Actions 2. Execute the Warrant Once the complaint in rem is filed with the court, an "arrest" warrant (i.e., a warrant for the arrest of the property that is the subject of the action) will be issued. According to Rule C(3) of the Supplemental Rules, the warrant is delivered to a U.S. Marshal for execution. However, Section 9(b) of the Act provides that duly designated EPA employees are authorized to obtain and execute warrants for the purpose of effecting a Section 13(b) seizure. It is the Agency's view that a seizure warrant may be served by either a U.S. Marshal or an EPA employee. These possibilities should be brought to the U.S. Attorney's attention, and the .Region should make known its preference. However, the Region should abide by the wishes of the U.S. Attorney if it Is preferred that the U.S. Marshal serve the warrant. 3. Notify Other Regions The Region should notify other Regions of its actions if there is reason to believe that the violative product is also in those Regions. Compliance With a Seizure The violation of a court-ordered seizure or decree of condemnation consti- tutes contempt of court. When any such violation is found, it should be reported promptly to the U.S. Attorney who filed the seizure action. Ittyppsltlon of a Seizure While pesticides or pesticidal devices under seizure are in the control of the court, the Regional Office will usually be called upon to recommend or approve the method of disposition and may be directed to supervise the court-ordered action In decrees of condemnation. When agreeable to the U.S. Attorney, the Regional Office should prepare the proposed consent or default decree to be filed by the U.S. Attorney. Reconditioning Where disposition is achieved by reconditioning, the person supervising the reconditioning under a consent decree should report the method of reconditioning, what examinations or tests were made, and whether the pop*"jf r^f*** nr" :Jf ptffiA&1 dfVlCP is .HOW. .In *»------- Chapter Eight In Bern Actions Agency Reimbursement Because the Agency will be reimbursed by the claimant for expenses incurred in the seizure, the Region should keep a record of all expenses incurred in connection with the supervision and disposition of the seized products. The schedule of expenses should be attached to the report of supervision and presented to the U.S. Attorney for collection concurrent with the payment of court costs (Exhibit 8-8). FIFKA GbBpliance/Enforceaent 8-30 Gnldft^r* M^M">1 1983 ------- Chapter Eight Exhibit 8-6 Model Complaint In Bern IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF United States of America Complaint In Rem TO THE HONORABLE JUDGE OF SAID COURT: This is a complaint in rea filed in behalf of the United States of America by the United States Attorney for this District, who represents This is an action in rem instituted pursuant to Section 13(b) of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended, 7 U.S.C. Sl36k(b), for the seizure for confiscation by a process in rem for condemnation of (name of the product in the caption), a product or Inrorted aa ,.a -.(pestlf* ^° ,-or jdrtlce ) within the •iiininc nf Section 2 of tfae Ifedexal Insecticide. Fungicide, and Rodenticide Act, as amended, 7 U.S.C. §136. Authority to bring this action is vested in the United States Attorney by 28 U.S.C.$547(2). II vWi^r* r:iwxfffT J~iff ••'4_ti9 action 7 ^J^S.C FIFRA Govpllance/Enforceaent 8-31 Guidance ^*tmai 1933 ------- Chapter Eight &hibit 8-6 III On or about ,19 the product was (transported, imported, sold, offered for sale) by " from to and the product remains unsold or in the original unbroken packages and is now in the possession of (person in possession and exact location) or elsewhere within the jurisdiction of this Honorable Court. IV The product is labeled, marked, and branded (in part) as follows: The product is in violation of the Act as follows: (State allegation with specific reference to unlawful acts) PIFBA Qmplisaee/Enforceaent 8-32 Goidance «a»««"ai 1983 ------- Chapter Eight Exhibit 8-6 WHEREFORE, in consideration of the premises, the complainant, United States of America, prays: (a) That the pesticide/device, be proceeded against and seized for condemnation and confiscation, and that it be disposed of as the Court may direct in accordance with the provisions of Section 13(b) of the Act [7 U.S.C. Sl36k(b)] and in conformity with the practice of this Court, and that the parties specified in paragraph II of this complaint 'and any and all other persons having or pretending to have any right, title, or interest in and to the product be notified to appear herein in order that they may answer all and singular the allegations herein set forth. (b) That this Honorable Court may enter all such orders, decrees, and judgments as may be necessary in the premises to grant further relief to your complainant and for the costs of this proceeding should such costs not be satisfied out of the proceeds of the sale of the product, jj this v^onorable Court should decree; the same to be sold. (c) That your complainant may have such other and further relief as the nature of the case may require. (Signature of U.S. Attorney United States Attorney for the District of VERIFICATION T "have read the foregoing pleading and know Its contents; vhich is true and correct of my own knowledge, except as to matters therein stated upon my information and belief, and as to such matters I believe it to be true. Executed on this day of (date) (location) Halted States Attorney FIFRA Compliance/Enforcement 8-33 Guidance MMIM*! 1983 ------- Chapter Eight Exhibit 8-7 Model Report of Supervision of Disposition UNITED STATES ENVIRONMENTAL PROTECTION AGENCY REPORT OF SUPERVISION OF DISPOSITION OF PESTICIDE OR DEVICE Pesticide or Device Detained Under (Stop Sale, Etc., Order, Seizure by Marshal; (EPA Seizure (warrant); Voluntary Recall; Give Place and Date of Detention) ( Sample No., I.F.&R. No., Court No._ Name of Pesticide or Device Nature of Violation Type of Disposition Order or Agreement (Consent Decree; Voluntary Reconditioning; Court-Ordered Destruction; Etc.) Method of Disposition (Reformulate; Relabel; Destroy; Etc.) Results of Disposition Action (In Compliance - Relabeled; Etc.) (Not in Compliance - Ineffective by Test; Etc., Give Test Results,.Etc.) Further Action Required (None or, Further Reformulation; Relabeling; Etc*) Remarks (Signature and Title of EPA Employee) (Place and Date) FIFRA Qa»pi -taTwo/nnf«i-f n»QTif 8-34 Guidance Manual 1983 ------- Chapter Eight Exhibit 8-8 Model Expenditure Report Foi UNITED STATES ENVIRONMENTAL PROTECTION AGENCY CHARGES FOR SUPERVISION OF DISPOSITION OF PESTICIDE OR DEVICE (Attached to Report of Supervision) Sample No., I.F.&R. No., Court No. Name of Pesticide or Device Amount of Pesticide or Device_ Method of Disposition Types of Charges Unit Charge Total Hours Days Miles Inspector Time Analyst Time Inspector Per Diem Analyst Per Diem Inspector Automobile Use Analyst Automobile Use Other Transportation or Miscellaneous Expenses (Itemize) Sub-Totals Grand-Total Remarks: (Signature of Inspector or Analyst) FIFRA CompUance/Enforceaent 8-35 Gi 1983 ------- Chapter Eight Exhibits FIPRA Qompl 1 ance/Eoforceaent 8-36 Guidance Manual 1981 ------- Chapter Eight 6 Settlement Agreements By their very nature, FIFRA civil actions do not involve settlement agreements. Nonetheless, an injunction or :dn rem (seizure) action that is granted 'to EPA *by a district court -is also usually monitored for compliance by the Agency. The violation of either type of civil action will subject the responsible party to a charge of contempt of court. FIFRA Compliance/Enforcement 8-37 ------- Chapter Eight Settlement Agreements FIFRA Compllance/Enforcement 8-38 Guidance Manual 1983 ------- Chapter Nine Judicial Enforcement: Criminal Actions Chapter Contents Page Statutory Authority 9-1 Basic "Enforcement Policy 9-1 Criteria for Identification of a Potential Criminal Action 9-2 Procedures for the Investigation and Referral of a Criminal Case 9-6 Exhibit 9-1: Criminal Enforcement Divisions: Field Offices 9-10 Exhibit 9-2: Memorandum (9 May 1983): Referral Procedure for Criminal Cases 9-11 Exhibit 9-3: Uniform Criminal Referral Package Format 9-16 F.LFKA cmpJaance/ianxorceaent y-i Guidance Manual 1983 ------- Chapter Nine Contents VlFRA CJownllance/Bafoi ort ant 9-1] ------- Chapter Nine Judicial Enforcement: Criminal Actions Statutory Authority Section 14(b) of FIFRA provides the following criminal penalties for the *' - of ~-v*y provision of the Acts (1) In General. — Any registrant, commercial applicator, wholesaler, dealer, retailer, or other distributor who knowingly violates any provision of this Act shall be guilty of a misdemeanor and shall on conviction be fined not more than $25,000, or imprisoned for not more than one year, or both. (2) Private applicator. — Any private applicator or other person not included In paragraph (1) who knowingly violates any provision of this Act shall be guilty of a •isdeneznoT .and shall on conviction *e fined not more •than "$ 1 ,000 , vr imprisoned ^f or- -not TBOT« than 30 ^lays , or both. Section 12 of FIFRA enumerates those acts considered unlawful under the Act (see Chapter Seven for a complete listing.) Bttforceaent Policy The objective of the pesticides enforcement program is to ensure compliance with the terms and provisions of FIFRA. The Act provides the Agency with a variety of administrative, civil, and criminal enforcement options to accomplish this goal. A broad range of potential overlap exists among * . Thf oirt j <*n] 1 j at - Apyf j — £he -Agency- j A -.free to FIFRA GoBpllance/Biforcement : 9-1 Guidance Manual 1983 ------- Chapter Nine Criminal Enforcement pursue criminal sanctions in every situation presenting evidence supporting the requisite elements of proof.* As a matter of enforcement policy and resource allocation, such an unrestrained use of criminal sanctions is neither warranted nor practical. The commitment of investigative and technical resources necessary for the successful prosecution of a criminal case is high. More Importantly, a criminal referral for investigation or prosecution can entail profound consequences for the subject of the referral. Accordingly, criminal referrals should be confined to situations that reflect the most serious cases of environmental misconduct—when measured by the nature of the conduct, the compliance history of the subject, or the gravity of the environmental consequences. Criteria for Identification of a Potential Criminal Action This section discusses the considerations that should be examined in determining whether to proceed with a criminal vis-a-vis administrative/ civil action. The Scienter Requirement An Individual who engages in conduct prohibited by statute or regulation can be prosecuted civilly or administratively without regard to the mental state that accompanied the conduct. Criminal sanctions, on the other hand, will be limited orginarily to cases in which the prohibited conduct is accompanied by evidence of a "guilty knowledge" or intent on the part of the prospective defendant. Referred to as the scienter requirement, this element of proof exists under virtually every environmental statute enforced by the Agency.** * Pesticide use of FIFEA violations are an exception to this general statement. Sections 26 and 27 of FIFRA establish standards and procedures for according to the States the primary enforcement responsibility (primacy) for pesticide use violations. Where a State has primacy, the Agency will not bring an enforcement action unless the State is unwilling or unable to address the situation. If the State has referred the matter to the Agency, the Agency will proceed as with any other case under FIFRA. ** One exception to this general rule is the Refuse Act, 33 U.S.C. 1407, which has generally been interpreted as a "strict liability" statute. [See, e.g., United States v. White Fuel Corporation. 498 F.2d 619 (1st Cir. 1974).] In addition, a prosecution for illegal discharges under the Clean Water Act can be based on negligent or willful conduct, 33 U.S.C. Sl319(c)(l). "Negligence" is not, strictly speaking, a form of scienter. FIFRA Coapllance/Eoforeeaent 9-2 Guidance Manual 1983 ------- Chapter Nine Criminal Enforcement Under FIFRA, criminal penalties are imposed only for "knowing" violations of the Act. The term "knowing" has been used in a number of other criminal provisions and has been interpreted to mean that the violative act must be done intentionally and not as a result of accident or mistake. To date, only one case has addressed the meaning of the word "knowing" as it is used in FIFRA. In United States v. Corbin Farm Services, 444 F. Supp. 510 (E.D. CA. 1978), the defendants were charged with the knowing use of a registered pesticide in a manner Inconsistent with its labeling. The label on the pesticide in question stated: "For water fowl protection do not apply...on fields where water fowl are known to repeatedly feed." The defendants had applied this pesticide to a field containing evidence of bird activity, which resulted in the death of migratory birds. The court found that in order to prove knowing activity, the government must show a general intent on the part of the defendants to do the act in question (i.e., the government was required to show that the defendant knew that he was using a pesticide when he sprayed the field). Proof of intent to violate FIFRA was not necessary. The ^requirement to prove a culpable mental .atate, -as well as a prohibited act, is certainly the clearest distinction between criminal and administrative/civil enforcement actions. The Nature and Seriousness of the Offense As a matter of enforcement policy and resource allocation, EPA will investigate and refer only the most serious forms of environmental misconduct for criminal prosecution. Of primary importance to this assessment is the extent of environmental ITMIf TIT'*'***^ ^ *""" **** "^BBy* ^•»«T*fc fn^TT d tttft h&S ''rmm*?'\'*T$"fTCTl^ Or 088 threatened by, the prohibited conduct. In general, this determination will depend upon considerations such as the duration of the conduct; the toxicity of the pollutants involved; the proximity of population centers; the quality of the receiving land, air, or water; the amount of Federal, State, or local cleanup expenditures; and public sentiment supporting strong enforcement action in response to a specific situation. is of particular importance in cases of the falsification or concealment of records, reports, or other Information. For example, even if a technical falsification case can be made, criminal sanctions may not be Appropriate if the distortion of information could not reasonably have been expected to have a significant impact on EPA's regulatory or decisionmaking process; However, where the impact is material, as in the case where the falsification activity aright can»e £PA to ^register m pesticide with *4cnons Li aled cai clnogenic potential , ^^tg 'TiBBi8 ••fair • be considered. FIFBA Compliance/Enforceaent 9-3 Guidance Manual 1983 ------- Chapter Nine Criminal Enforcement The Need for Deterrence Deterrence of criminal conduct by a specific individual (individual deterrence) or by the community at large (general deterrence) has always been one of the primary goals of criminal law. Where the offense is deliberate and results in serious environmental contamination or human health hazard, the need to achieve deterrence through the application of strong punitive sanctions will almost always exist. The goal of deterrence may, on\>ccasion, justify a criminal referral for an offense that appears relatively minor. This would be true, for example, for offenses that—while of limited importance by themselves—would have a substantial cumulative impact if commonly committed. This might also be true when addressing violations by an individual with an extended history of recalcitrance and noncompliance. The Compliance History of the Subject(s) The compliance history of the subject of a potential criminal referral also should be considered in determining the appropriateness of criminal sanctions. As a general rule, criminal sanctions become more appropriate as the incidents of noncompliance increase. The occurrence of past enforcement actions against a company or the failure of administrative/ civil enforcement, is certainly not a prerequisite to a criminal referral. However, a history of environmental noncompliance will often indicate the need for criminal sanctions to achieve effective individual deterrence. The Need for Simultaneous Administrative/Civil or Enforcement Action Simultaneous administrative/civil and criminal enforcement proceedings are legally permissible, United States v. Kordel, 397 U.S. 1, 11 (1970), and on occasion are clearly warranted. However, separate litigation staffs would need to be appointed on initiation of a grand jury investigation, if not before. Furthermore, the pursuit of simultaneous proceedings would provide fertile grounds for legal challenges to one or both proceedings that, even if unsuccessful, would consume additional time and resources. Thus, parallel proceedings should be avoided except where clearly justified. In this regard, it should be noted that some of the goals of a criminal prosecution, including deterrence, can be achieved through an administrative or civil action that secures substantial civil penalties in addition to injunctive relief. Moreover, recent experience indicates that while some eases may result in periods of Incarceration, criminal sentences will often be limited to monetary fines and a probationary period. In light of this reality, the use of the additional time and resources necessary to pursue a criminal investigation is often not justified. FIFRA Cn^pi < «Mii"*/Hnf orrrmcnt 9-4 Gnida"?* Manna 1 1983 ------- Chapter Nine Original Enforcement Criminal Enforcement Priorities The Criminal Enforcement Division, in conjunction with the Agency program offices, has developed investigative priorities in each of the Agency's program areas. The purpose of this effort is to focus the limited investigative resources of the Agency on the most serious cases of environmental misconduct. These priorities are fluid and will be modified to reflect additional regulatory programs in the Agency as they develop. In addition, the creation of these priorities does not preclude the possibility of criminal. referral for conduct not falling within these Investigative priorities . The order of listing is random. It is not Intended to create a ranking within the priorities for a statute. Nor is any statute given higher priority than another. The priorities for FIFRA are listed below. Failure To Report Information on the Unreasonable Adverse Effects of a Registered Pesticide: Section 14(b) of FIFRA, 7 U.S.C. §1361(b), £$ -for the knowing violation .of any •provision of ±he Act. 'Section T2Ca)(2)(N). provides 'that it is unlawful to fall to submit information required by Section 6(a)(2). This section requires a registrant to report to EPA any information that the registrant obtains after the pesticide is registered regarding unreasonable adverse effects of the pesticide on the environment. A high investigative priority will be placed on knowing violations of this reporting requirement. Falsification of FIFRA Records. Sections 12(a)(2)(M) and 14(b) of FIFRA, 7 U.S.C. SSl36j(a)(2)(M) and 1361(b), establish misdemeanor penalties for the knowing falsification of specified records maintained or filed under FIFRA, Including registration data. A high investigative priority will be placed .«*•«• <•»< fry frhaf tma— of TOFSA, 7 U.S.C. SSl36J(a)(2)(G) and 1361(b), establish misdemeanor penalties for the knowing use of a pesticide in a manner Inconsistent with its labeling. If FJJTKA uompJJLance/ Bozorcement 9-5 Guidance Manual 1983 ------- Chapter Nine Original referred by a State with primary use enforcement responsibilities, a high investigative priority will be assigned to misuse cases that result in, or threaten, significant environmental contamination or human health hazard. Illegal Distribution of Unregistered Pesticides. Sections 12(a)(l)(A) and 14(b) of FLFRA, 7 U.S.C. SSl36j(a)(l)(A) and 1361(b), establish misdemeanor penalties for the knowing distribution, receipt, etc. of an unregistered pesticide. The pesticide registration process outlined in Section 3 of FIFRA, 7 U.S.C. Sl36a, is the cornerstone of EPA's program to monitor and regulate the safety of pesticides. A high investigative priority will be placed on illegal transactions involving unregistered pesticides that result in, or threaten, significant environmental contamination or human health hazard. Procedures for the Investigation and Referral of a Criminal Case Investigation The Criminal Enforcement Division maintains the primary role in the investigation and referral to the Justice Department of allegations of criminal misconduct. The division is staffed by experienced criminal Investigators located in each of five area offices and EPA Headquarters. (Exhibit 9-1 contains a list of the division's area offices and their scope of responsibility.) An initial "lead" or allegation of potential criminal activity may come to the Agency from any of several sources, including State agencies, routine compliance inspections, disgruntled plant employees, or citizen groups. Regardless of its source, it should be transmitted immediately to the Special-Agent-In-Charge of the responsible field office, who will open a case file* and assign a criminal investigator (known as a Special Agent) to the lead for follow-up. If the reliability of the lead is unclear, the Special Agent will conduct a preliminary inquiry solely to determine the credibility of the allegation and to make an Initial assessment of the need for more thorough investigation. This initial inquiry will be brief and will not involve extensive commitment of resources or time. Its sole purpose is to reach an initial determination on the need for a complete investigation. * The opening of a case file does not commit the Agency to proceed with a criminal referral at the culmination of the investigation; nor does it reflect an Agency decision that criminal conduct has occurred. All enforcement options remain open and should be considered until referral to the Justice Department. feUFJLA tiaapliasice/Snforceaent1F6 QaLAanrr Manual 1983 ------- Chapter Nine Criminal Enforcement Once a determination has been made by the Criminal Enforcement Division that a thorough investigation is warranted, the Special Agent will immediately contact the Regional Counsel in the Region where the investigation is to be conducted. The Regional Counsel will ensure that no civil enforcement action is pending or contemplated against the Investigative target and will assign an attorney to work with the Investigator during the case development process. The regional attorney and Special Agent will also contact the appropriate regional program office to ensure that no administrative enforcement action is pending or contemplated. In addition, where the need for technical support during the Investigation is contemplated, the regional program office will be asked to assess the availability of technical resources and, when appropriate, to designate a specific Individual to work with the Special Agent during the course of the investigation. While simultaneous administrative/civil and criminal enforcement actions are legally permissible, they will be the exception, rather than the rule. As a general rule, an administrative or civil proceeding will be held in abeyance pending the resolution of the criminal investigation. One exception to this general rule will be those situations in which emergency remedial response is mandated. In these situations, however, the criminal investigation will not be initiated without the prior approval of the appropriate Regional Counsel and Enforcement Counsel. Management of the Investigation will be the primary responsibility of the Special Agent, acting under the supervision of the Field Office Special-Agent-In-Charge. The Special Agent will be responsible for determining the basic investigation approach and will take the lead in conducting interviews; assembling and reviewing records; planning and executing surveillances; coordinating with State, Federal, and local law enforcement agencies; planning and executing searches; developing Informants; ?and performing otter Investigative matters. A technical person •wHT-workTrLtfc the Special Agent dnriiig those portions of an Investigation requiring technical expertise. Notice of Contemplated Proceedings Section 9(c)(l) of FIFRA requires the Agency to give notice and an opportunity to be heard to those persons* against whom enforcement TTwr^Bil'l IIIBT t -'mAldi 4zlse'- '.&• a.Tevolt ------- Chapter Nine Criminal Knfor Referral A referral recommendation will be developed when the independent field investigation has been exhausted, or when it can or should proceed no further without the initiation of a grand jury investigation by the Justice Department. Where a referral is made for further investigation by a grand jury, the task of creating a complete referral package is difficult since the case has not yet been completely developed. Therefore, a streamlined ferral process has been initiated for these cases to eliminate inefficiency and to provide for the more natural development of criminal cases. See Exhibit 9-2 for a copy of these procedures. At this point, the results of the investigation will be assembled in a referral package. The preparation of the overall referral package will be the responsibility of the regional attorney assigned to the investigation, working in conjunction with the Special Agent. Once the package is prepared, it will be reviewed by the S pedal-Agent - In-Charge and the Regional Counsel, who will act as joint signatories. Technical portions of the package will also be reviewed by the regional or Headquarters program office, or the NEIC—depending on the source of technical support. During this technical review, the availability of technical resources to support litigation should also be reviewed and specifically confirmed by the appropriate technical office. Following completion of the referral package and concurrence in the referral recommendation by the Special-Agent-In-Charge and the Regional Counsel, three copies of the referral package and all exhibits should be directed to the Associate Enforcement Counsel for Criminal Enforcement, Criminal Enforcement Division (LE-134E), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington D.C. 20460. No copies of the referral package will be sent to the local United States Attorneys Office or the Justice Department until Headquarters has reviewed and approved the referral. If either the Special-Agent-In-Charge or the Regional Counsel believe the referral should not be made, that official will Include a statement of the reasons underlying this position and make an alternative recommendation (i.e., close out investigation, change to civil referral, change to administrative action, etc.). The package will, nevertheless, be directed to the Criminal Enforcement Division for review; a final referral decision will be made by the Associate Administrator for OLEC (or the Associate Administrators designee). The Headquarters review will focus on the adequacy of case development; adherence to the criminal enforcement priorities of the Agency; legal issues of first impression; consistency with related program office policy; and general prosecutorial merit. In cases Involving particularly complex issues of law, the Criminal Enforcement Division will also consult with General Counsel attorneys. If, following this review process, the referral recommendation is accepted, referral packages will be directed simulta- neously to the Justice Department and the appropriate United States Attorneys Office. Appropriate cover letters will be drafted by the Criminal Enforcement Division. FXFRA £m«pllaiice/K"*oTre?m'p"«' 9-8 Guidance *«•""*1 1983 ------- Chapter Nine Cr*«rf«*i Enfor Referral Package Format Referral packages should be prepared in accordance with the Uniform Criminal Referral Package Format effective on January 1, 1982. (See Exhibit 9-3.). However, referral packages prepared for those cases referred for further investigation by a grand Jury should be prepared in accordance with the Hay 9, 1983 guidance concerning referral procedure for criminal cases (see Exhibit 9-2). References Agency employees Who are involved in the investigation and referral to the Department of Justice of allegations of criminal violations of FIFRA should familiarize themselves with the Agency documents listed below. Although a digested form of some of this material is contained in this section, most of the items are not covered in detail. The documents are contained in the General Enforcement Policy Compendium, or copies of the documents may be f*^ "P v--tbe' £ridsal Enforcement Division* RP^ .fleadouarters • • General Operating Procedures for the Criminal Enforcement Program (October 31, 1982); • Criminal Enforcement Priorities; • Agency Guidelines for Participation in Grand Jury Investigations; • Agency Guidelines for the Use of Administrative Discovery Devices in the Development of Potential Criminal Cases; • Policy and Procedures on Parallel Proceedings at the EPA. ------- Chapter Nine Exhibit 9-1 Criminal Enfor t Divisions: Field Offices Philadelphia Field Office (Regions I, II and III) Special-Agent-In-Charge Criminal Enforcement Division EPA - Region III Curtis Building 6th & Walnut Streets Philadelphia, PA 19106 PTS 597-1949 Atlanta Field Office (Regions IV and VlT~ Special-Agent-In-Charge Criminal Enforcement Division EPA - Region IV 345 Courtland Street, N.E. Atlanta, GA 30365 PTS 257-4885 Chicago Field Office (Regions V and VII)" Special-Agent-In-Charge Criminal Enforcement Division EPA - Region V 230 South Dearborn Street Chicago, IL 60604 PTS 886-9874 Seattle Field Office (Regions IX and xT Special-Agent-In-Charge Criminal Enforcement Division EPA - Region X 1200 6th Avenue Seattle, WA 98101 PTS 399-9874 Denver Field Office (Region Special-Agent-In-Charge Criminal Enforcement Division National Enforcement Investigations Center Box 25227 Denver Federal Center Denver, CO 80225 PTS 234-2158 * The Denver Field Office is located at the National Enforcement Investigations Center. In addition to Region VIII cases, its responsibilities include cases that overlap the Jurisdiction of field offices. Assignment of these cases will be the responsi- bility of EPA Headquarters. FIFRA Go*pliance/Enfor 9-10 Guidance Manual 1983 ------- Chapter Nine Exhibit 9-2 Referral Procedure for Criminal Cases UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON. MAT 9BS3 i CM>»m.i«iiMT MEMORANDUM SUBJKCTs Referral Procedure for Criminal Cases ntOMs Courtney M. price (\CuJ^ ^ .w Acting Associate Administrator 'Counsel TO* Regional Counsels, Regions I-X All SAZCs, Criminal Enforcement Division Onder the current General Operating procedures, a criminal referral to the justice Department may be made for one of two reasons) for prosecution (where the investigative effort is complete and we believe the crime is capable of being proved); and for further investigation in conjunction with the Justice Department. In the latter situation—"referrals for further investigation*—the scope of the ultimate prosecution, and even the identity of defendants, may well not be known. The •of ^iie case xattwr ^ttosn -tto -.jJicurporsta «£iaal ••Agency oacisioni on the viability or advisability of a prosecution. As such, it can and often does occur at an early stage in the case development process. In these 'situations, the task of creating a complete referral package is difficult—in light of the fact that the ease has not yet been completely developed. Zt is also time consuming, and thus can prejudice the investigation. The time spent in attempting to prepare a complete referral fcegJa«*i i, "------- Chapter Nine Exhibit 9-2 Referral Procedure for Criminal Cases -2- To eliminate this inefficiency, and provide for the more natural development of criminal cases, a shortened referral package will be used where the purpose of the referral is for further investigation in. conjunction with the Justice Department, rather than to incorporate a complete investigative package. (The format appears as Attachment A.) This package will provide a basis on which to make the best possible assessment both at the Regional level and at EPA Headquarters on the merits of the potential case. 'At the same time, it will provide a vehicle for the more rapid transmission of our investigative work product to prosecutors with the Justice Department, who will then become part of the criminal case development team. The modified referral package will normally be prepared by the Special Agent assigned to the investigation, who will be most familiar with investigative activity to date. The package must be prepared in close coordination with Regional legal and technical personnel assigned to the investigation. As under existing procedures, the referral will be approved by both- the Special-Agent-in-Charge and the Regional Counsel before transmission to EPA Headquarters for approval. Cover letters to the appropriate United States Attorney and to the Land and natural Resources Division will be drafted at EPA Headquarters, for the signature of the Associate Administrator. Questions on this procedure should be directed to Peter Beeson (382-4543). It is our hope that these modified procedures will ensure the most efficient possible development of our c- "inal cases. Attachments FIFRA Compliance/Enforcement 9-12 Guidance Manual 1983 ------- Chapter Nine ggfaibit 9-2 Referral Procedure for Criminal Cases ATTACHMENT A r KEMORANDOM FXDM: Special-Agent- in-Charge Field Office Criminal Enforcement. Division Regional Counsel , Region THRO: Associate Enforcement Counsel Criminal 'Enforcement Division Enforcement Counsel TOi - . Associate Administrator and General Counsel Attached for your consideration are aaterials assembled by this Agency in a criminal investigation against It i» tte fiplaian «f oar off! that further development of this case should proceed in close coordination with the- Justice Department. An overview • » of the nature of this investigation is provided below for your information. We recommend immediate referral to the (O.S. Attorney/Federal District) and to the Land and Natural FIFRA Qmpllance/Eoforc^nt 9-13 Guidance Mana*X_1583. ------- Chapter Nine Exhibit 9-2 Referral Procedure for Criminal Cases REFERRAL PACKAGE (Mane of Case) (Hame of District) Z. Identity of Subjeet(s) of Investigation* Individual(a)i 1. -Not* 2. Title 3. Age 4. Borne/work address 5. Currant employment 6. Criminal record, if any 7. Prior EPA enforcement action 8.- Other partinant information Corporation(s)i 1. Base and nature of business 2. Parent company 3. Susidiaries 4. Address of faeility(ies) associated with offenses S. State of incorporation 4. Size of company 7. Prior EPA enforcement action t. Other pertinent information , • II. Nature of Activity under Investigation 1. Location and duration 2. Venue 3. Significance of Activity (A brief statement of reasons underlying the need to address the misconduct with criminal sanctions.) FIFRA Compliance/Enforcement 9-14 Guidance Manual 1983 ------- Chapter Nine Exhibit 9-2 Beferral Procedure for CrlavLnal Cases -2- XZZ. Statutory Offenses l/~ Applicable Statutes; (A summary of Federal environmental «n3"~related laws potentially violated by the activity, accompanied by pertinent citations to th* United States Code and the Code of Federal Regulations) 2. evidence Gathered to Bate: (A brief summary of available evidence, accompanied-%y copies of selected investigative reports prepared within the . Criminal Enforcement Division that reflect this evidence (for example, surveillance reports or Jjterview summaries.) XV. Personnel Assigned 1. Special Agent 2. Regional Attorney 3* Technical Staff FXFRA Compliance/Enforcement 9—15 Guidance M«MMI 1983 ------- Chapter Nine Exhibit 9-3 Page VI. Legal Issues VII. Environmental Impact VIII. Becommendation Appendix A. List of Witnesses Appendix B. List of Exhibits Appendix C. Exhibits ...• A discussion of each Individual section follows. Body of the Report Section I—Introduction. The introduction will provide a synopsis of the investigation to orient the reader. It should be brief. A detailed discussion of the evidence will be provided in a subsequent section of the report. Within the introduction, the following areas should be addressed: • The identity of the corporate and Individual subject(s) of the investigation; • A brief description of the nature and duration of the criminal activity under investigation; • Venue (i.e., the Federal district(s) in which the offense occured). If venue lies in more than one district, an explanation should be Included for the Region's choice of one Federal district over another for referral; and • The regional recommendation underlying the referral. Section II—Statutory Authority. This section should include the statutory provisions that provide the basis for the referral. Pertinent portions of each statute should be quoted in full, followed by a listing of the elements of each offense that must be provided in a subsequent prosecution. Section III—Subjects of the Investigation. This section will be used to provide pertinent background data on the subjects of the referral. For each individual subject, the following Information should be included: • Name and title; • Approximate age; • Home and work addresses; • Mature of current employment; and • Criminal record, if known. Qmpliance/Enforceaent 9-17 Guidance Mamaa! 1983 ------- Chapter Nine Exhibit 9-3 For each corporate subject, Include: « Name of company and parent corporation, if appropriate; • Complete address of company; • Complete address of facility associated with offenses; • State of incorporation of corporate subjects; • Registered agent for service; and • A brief statement of the business, profits, and size of the company. Section IV—Enforcement and Regulatory History. This section should include a description of all known enforcement activity (State and Federal) relating to environmental matters taken against the subject in ate past. , In addition, any previous efforts by EPA to remedy .the present problem through Informal, administrative, or civil means should be discussed.* Finally, if the Region is recommending that the criminal referral be pursued simultaneously with a parallel civil/regulatory proceeding against the subject(s), this fact should be highlighted. The steps taken in the Region to ensure proper coordination and separation of the parallel proceedings should also be described. Section V—Description of the Evidence. This section will constitute the major portion of the report. Its function is to present the ilts /of .^the Megaton** investigative activity and to demonstrate how the criminal -conduct •uncovered1 "in that Investigation •will be 'proved at trial. Background. There is no one proper way to present the evidence. Any method that is clear and organized is acceptable. A chronological approach is recommended, however, both because it is simple to follow and because prosecutors often present their evidence before the grand .Jury and at^trial within a chronological framework. Regardless of the organization chosen, all substantial facts detailed in this section should be supported by some item of evidence—a witness Interview, a letter from EPA correspondence files, an NPDES permit, results from a compliance Inspection, technical analysis of a lakes :**M1^ ifrfT*"C Chi* xeport &o ovoid duplication. If facts relating to past regulatory or enforcement activity are discussed in subsequent sections (e.g., as evidence of a "willfull" or "knowing" violation), only a brief summary should be included In this section. FXFRA Compliance/Enforcement 9-18 Guidance tirnmsT 1983 ------- Chapter Nine Exhibit 9-3 pollutant sample, a photograph, etc. Copies of these items of evidence should be included, in turn, as exhibits to the litigation report, for easy reference by the reviewing personnel at EPA Headquarters, the Justice Department and the United States Attorneys Office.* The existence of evidentiary support for the factual allegations contained in the referral is crucial. The end goal of the referral process is a successful prosecution. The question is not, ultimately, what happened but whether it can be proved at trial. Required Information. In completing Section V, the following items should be included (although not necessarily in separate portions of the section): • A detailed review of all facts constituting the alleged criminal behavior. Speculation should be avoided. If the evidence currently available does not support one or more elements of the offense(s) under investigation, this should be highlighted, since this will assist in focusing future investigation by grand Jury or otherwise; • Any statements by the subject(s) of the investigation pertaining to the subject matter of the investigation. Written, as well as oral, statements should be included; • Evidence indicating willful or knowing behavior by the investigative targets; * The following paragraph is an example of the chronological presentation of evidence supported by exhibits: On May 1, an NPDES permit was issued to Company X that contained the following provisions...(see Exhibit 1, NPDES permit). On May 5, the plant's waste treatment system ceased operation. (See Exhibit 2, Interview Report of Informant A.) At that time, Company X faced several imminent production deadlines. (See Exhibit 3, Sales Contract Between Company X and Company Y.) Production continued, resulting in the discharge of raw sewage between May 5 and July 5. (See Exhibit 4, Analytical Reports Provided by Former Chemist of Company X.) Discharge monitoring reports submitted by Company X for this period nevertheless falsely reported compliance. (See Exhibit 5, Company X DMRs.) Moreover, In response to an EPA Inquiry, Company X reported the successful operation of its waste treatment system on July 1, almost two months after the breakdown. (See Exhibit 6, Letter, Company X to EPA.) FIFRA Qr*Bpi -t *nc*/Vnf*vrf«w«t- 9-19 Guidance Manual 1983 ------- Chapter Nine Exhibit 9-3 • Any facts that bear on the reliability of the available evidence. This might include, for example, equipment breakdowns during technical sampling, or prior inconsistent statements of a government witness. Ultimate conclusions should not be made on the reliability of a particular witness or piece of evidence in the report; rather, simply include all facts relevant in assessing the reliability; and • A complete chronology of contacts between EPA and the subject (s) concerning the environmental problem underlying the: referral. Section VI— Legal Issues. In preparing a case for trial, the Justice Department's prosecutor will want to consider both the weaknesses in the government's case and the affirmative defenses available to the defendants. In completing this portion of the referral package, consider : J)ef ""PCS.* -. Thin .night .Include , -,for example* .Arguments that .a. di scharge of pollution WAS not Into a navigable water for the United States and therefore not regulated under the Clean Water Act; or that dumping activity did not Involve a "hazardous waste" identified or listed under the Resource Conservation and Recovery Act. • Evidentiary Challenges. This might Include, for example, challenges to the methods used to obtain evidence, or to the government's ability to authenticate evidence due to a break in the chain of custody. • Equitable Defenses . This might Include, for example, EPA's '^SffcV 3 1 fT ^ **"^?r^regu3 ytyy ' it*"mfn*f