, D R? q PROP ” TSCA SECTIONS 5 & 8 PRAGTIC’E MANUAL OFFICE OF ENFORCEMENT. ANP cOMPLIANCE MONITORING TOXICS LITIGATION DIVISION ------- A ------- N OVERVIEW OF TEE J!OXIC :SUBSII!ANCES CONTROL CT PUBLIC -LAW 94—469 ENACTED OCTOBER 11, i976 A series o events occurred in the late 1960’s and early 1970’s which rais’ d a new level of concern in the United States and particular:..y in the Congress of the United States. As stated in the opeiing paragraphs of the Toxic Substances Control Act (TSCA), “Congress finds...human beings and the environment are each being exposed each year to a larger number of chemical substances and mixtures.” In creating the law, many attributes of the Federal Pesticide Act as amended in 1972, previously known as the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) were used. Before new pesticide products, or new uses for existing pesticides are allowed to enter the market place, the products must undergo a very thorough review to assure that no unreasonable risk or harm shall come to human health or the environment. This was what was envisioned when TSCA was created. The short title given the act by Congress was The Toxic Substances Control Act (TSCA). Of the 68,500 plus chemicals and mixtures regulated by the act, only a relatively small percentage are truly hazardous or toxic to humans and/or the environment. Less than 500 chemicals are listed in the Chemical Hazard Emergency Profile, although slightly over 700 are listed under CERCLA. This is only slightly over 1.0% of all chemical substances and mixtures listed on the TSCA inventory. A more proper name for the law would have been the’ 1 Commercial Chemicals in Comnterc Act.” The Toxics Program, as it became known, was implemented during the late 1970’s. It was placed in the Office of the Assistant Administrator for Pesticides, which then became the Office of the Assistant Administrator for Pesticides and Toxics Substances. The Assistant Administrator for Pesticides and Toxic Substances consists of four offices and 17 divisions under his/her control for the administration of FIFRA and TSCA; eight divisions make up the Office of Toxic Substances. Rather than attempt to explain the activities of each division and branch in the Office of Toxic Substances, TSCA will be described according to the activities mandated by each section of the act. Regional responsibilities will be described where appropriate, but most activities occur primarily in EPA headquarter’s offices. SECTIONS 1 & 2. TABLE OF CONTENTS, FINDINGS, POLICY, AND INTENT. ------- Section 1. of the Act consists ;of -the title and table of contents. Section 2 explains the findings, policy and intent of the Act. It is in the closing paragraph of section 2 where the dministrator is directed to consider the environmental, e:onomic and soc4al impact of any action the Administrator might take under the Act. - In other words, TSCA is a ri k-benef it statute similar to the FIFRA. As was briefly mertioned earlier, chemicals subject to review under TSCA, and reçulations which are promulgated for the control of a chemical suL stance must be weighed between the health and environmental berief its to be realized, as against the cost to society for those benefits. If the social and economic cost is greater than the beneficial costs, the regulation will not come to pass. The Administrator must exercise his authority to con- troll and regulate chemical substances and mixtures which are inminent hazards in such a manner as not to impede unduly or create unnecessary economic barriers to technological innovation. It is readily apparent any chemical control regulation must be very carefully developed. And as will be expanded upon under section 9 of the Act, other factors must also be considered. SECTION 3. DEFINITIONS. Section 3 contains the definitions of various terms and words used throughout the Act. The definitions section of most laws is often not thought of as being one of the significant sections of the Act, but that is not necessarily true. Many actions often hinge on the literal translation, or policies developed, for the use of a word or term. The term chemical substance under TSCA is defined as “.. .any organic or inorganic substance or a particular molecular identity, including -- 0 any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature and 0 any element or uncombined radical. The definition has been defined further to include biological or genetically engineered organisms (microbes) which are considered to be chemical substances. This definition extends to all microbial biotechnology products which are not covered under other regulatory authorities, e.g. foods, drugs, cosmetics, and pesticides. Substances such as alcohol, tobacco and explosives, and nuclear materials are also excluded from TSCA. “Distribute in commerce” and “distribution in commerce” has a similar meaning as that found in FIFRA. The term(s) means the introduction into commerce (sale), holding for distribution, or distribution of a chemical, substance or article. ------- 3 “Manufacture TM includes the importation of a chemical substance into the territory of the US. - Additional d3finitions found in section 3 include process, fixture, new chemical substance, etc. SECTION 4. “ESTING OF CHEMICAL SUBSTANCES AND MIXTURES Section 4 of TSCA provides the Administrator with the authority to require such testing as is deemed necessary to assure a chemical will not constitute an unreasonable risk to health or the environ 1 uent. Testing may be required to assure any phase of the manufacture, distribution, useage, storage or disposal of a chemical substance does not present a hazard to human health or the environment. Reasons for such testing may include an insufficient data base to assess human exposure and potential harmful effects; substantial quantities will be produced; or the production of a significant, but unknown quantity may impact the environment. The Administrator can require health and environmental effects standards to be established for the development of test data for carcinogenesis, mutagenesis, teratogenesis, behavioral disorders, cumulative or synergistic effec ts, etc. Further, the methodologies for these tests may include epidemiologic studies, serial or hierarchical tests, in-vitro tests, and/or whole animal tests. The Administrator must consult with the Director of the National Institute of Occupational Safety and Health (NIOSH) before conducting epidemiologic studies of employees. At least once each year the standards for development of test data must be reviewed for adequacy. Proceedings can be initiated for revision of the standards if warranted. For those chemicals and mixtures for which testing standards have been established, any person wishing to manufacture or process the substance must conduct testing as prescribed. The administrator will allow two or more persons to designate a qualified third party to conduct the testing (contract laboratory in most cases). Any person availing themselves of the data derived from such testing shall share in the cost of the testing for the period of the reimbursement period. The reimbursement period may be of variable length as determined by the Administrator. An exemption process exists for those persons who can demçnstrate the chemical or mixture in question is equivalent to a chemical or substance for which data already exists, or is being prepared pursuant to a rule; or the data would be duplicative of data in existance. Participation in sharing the costs of research by the exempted party is required if the exemption is granted during the reimbursement period. ------- 4 The reimbursement period is normally five years in length, unless the period of time to develop the data exceeded five years, then the longer period applies. The Administrator may promulgate rules for the determination of fair and equitable reimbursement by others to the person(s) who developed the required data. Test data received by the Administrator pursuant to a rule must be acknowledged by the administrator in the form of a notice in the Federal Register within 15 days of receipt. Subject to the trade secret requirements of section 14, the notice must identify the chemical substance or mixture for which the data was received, a list of the uses of the chemical or substance, and the type of data which was prepared. To assure the agency keeps abreast of the uses and hazards of the chemicals used, a special eight member committee was established under section 4(e). The committee is made up of a representative of each of the following agencies: the Environmental Protection Agency (EPA), the Department of Labor representing the Occupational Safety and Health Act (OSHA), the Council on Environmental Quality (CEQ), the National Institute for Occupational Safety and Health (NIOSH), the National Institute of Environmental Health Sciences (NIEHS), the National Cancer Institute (Nd), the National Science Foundation (NSF), and the Department of Commerce (DOC). Up to fifty chemicals may be placed on the list to which the administrator should give priority consideration for the development of test data. The administrator must respond qithin 12 months from the date cf the list by either initiating a proceding under section 4(a), or publish within the Federal Register the reason(s) for not initiating a proceding. The list will be reviewed every six months by the committee to determine if revisions are needed, or chemicals should be added. Priority factors used to determine placement of a chemical on the list include the ability to cause cancer, or contribute to the development of cancer, gene mutations or birth defects. Other factors such as the quantity produced, extent or potential for human exposure, chemical relationship to similar chemicals which are known to cause adverse effects upon human health or the environment, the ability to conduct such testing, and that the results from such testing would be useable may be considered. If data becomes available as a result of testing under the act, or from any other source, which indicates a chemical substance or mixture presents or will present an unreasonable risk to human health or the environment, the administrator has 180 days to initiate action under either TSCA sections 5, 6, or 7 to reduce such risk, or publish in the Federal Register a finding that such a risk is not unreasonable. ------- -—5— SECTION 5. XANUFAC URING ND PROCESSING NOTICES ip to this point we tiave not discussed how new chemicals, or new uses for existing chemicals, are screened before coming into the market p1ac . Initially, in 1979, aTSCA invento:7 of all chemicals in use was established. This inventory included any chemical substance previously made which was in use or had the potential to be used, and any chemical or substance imported into the U’iited States for use. After the cutoff date, all new chemicals manufactured or imported into the United States, or any significant new use of an existing chemical as determined by the Administrator, must be submitted to the administrator for review. In addition to the person’s intent to manufacture, import or process, data such as would be produced under section 4 of the act must be submitted if the chemical is subject to such rule, or such data as the applicant believes will show the chemical substance will not present an unreasonable risk to health or the environment. The administrator (Chemical Control Division) has 90 days to review the data and make a determination of unreasonable risk concerning the chemical substance. - If the applicant has not been advised further information is required, or the review period has been e;tended, the applicant then may begin commercial production. Wilhin 30 days of the first commercial batch, a Notice of Intent to Manufacture must be submitted to the agency. The new chemical will then be added to the chemical inventory. The agency also has the option of allowing the material to be made under special circumstances. These could be limited volumes, special warning statements must accompany the product, special packaging or handling instructions, or allow production while simultaneously requiring health and/or environmental effects testing under section 4 to be conducted. If the agency determines the risk of the chemical is too great, the chemical may be denied production, or in some manner restricted in its use, distribution, labeling etc. Chemicals which are produced under what is known as a Test Marketing Exemption (THE) may be marketed in amounts up to 1000 pounds. Research and development chemicals must be accompanied by labeling which indicates the status of the product. The product may only be used by research personnel, and any unused portion must be disposed of as a waste. SECTION 6. REGULATION OF HAZARDOUS CHEMICAl 1 SUBSTANCES AND MIXTURES This is the section of the act most people are familiar with as a result of the regulations for the ban and phaseout for PCBS. Other chemicals which have come under section 6 regulations over the past years are dioxins (now handled by RCRA), asbestos, hexavalent chromium and to a small degree, ------- 6 chlorofluorocar1 óns.(CFCs); Section 6 allows the Administrator restrict or proh itthe manufacture, processing, distribution in commerce, -use or disposal .of a chemical substance or mixture if any activity or combination of activities might present (will present) an unreasonable risk of injury to health or the environment. Such action may only apply to a limited geographic area if the circumstances were such to justify that approach. The Administrator may even go one step farther and require an individual manufacturer or processor to detail his manufacturing procedures, quality control and assurances that a product will not constitute an unreasonable risk to health of the environment The agency may require the manufacturer or processor to provide notice to purchasers or the general public of such risk. He may also be required to buy back or replace the chemical substance in question according to the order given by the Administrator. The section also includes the provisions for promulgating regulations, hearings, an opportunity for comment, and compensation under the rule. So far as is known, TSCA is the only law where a specific chemical (PCBS) was identified by Congress directing the Administrator to develop regulations within six months of enactment of the law. SECTION 7. LNHINENT HAZARDS An ‘Imminently Hazardous Chemical substance or mixture” means a chemical substance or mixture which presents an imminent and unreasonable risk of serious or wf.despread injury to health of the erwironment. Section 7 authorizes the Administ tor tc commence a civil action in any district court in tha United States for seizure of an imminently dangerous chemical substance, mixture or article containing such a substance or mixture; or to seek relief against any person who manufactures, distributes in commerce, processes, uses or disposes of any imminently hazardous chemical substance or mixture, or article containing the same. If the situation dictates, the Administrator may commence simultaneous actions for seizure and relief. Relief may constitute recall, notice to purcha ers, notice to the public, replacement or repurchase of the chemical substance or article containing same, or any combination of the above. If no rule exists under section 6 for the chemical substance or article which is considered to constitute an imminent hazard, a rule will be developed. The action(s) under section 7 provides the period of time required to protect health and the environment until the rule becomes final. SECTION 8. REPORTING AND RETENTION OF INFORMATION ------- —7— The Administrator is given the authority to require records and reports as he deems necessary for the reasonable administration f the act. The small manufacturer, processor, and research rind development chemi3t are not exempt from this .requireirent if it is determined such records are necessary for the effective enforcement of the ac:. Small manufacturers and processors as identified by joint agreement between the Administrator end the Administrator of the Small Business Administration may be exempted from some rule requirements. One of the first data gathering aspects of the act was t.he compilation of the TSCA chemical inventory which was published for the first time in 1979. The inventory listed all chemical substances manufactured (imported) or processed in the United States. The list did not include any chemical which had not actually been manufactured or processed within three (3) years of the effective date of the act. Small quantity chemicals for research and development were also excluded from the inv ’nto y listing. The initial inventory published in 1979 contained around 60,000 chemicals. The inventory has been updated twice since then to include new PNN chemicals and significant new use rule (SNUR) chemicals. Section 8(c) requires manufacturers, proce sers and distributors to maintain records of any significant adverse reactions to health or the environment which might be attributed or alleged to have been caused by a chemical substance. Such records are required. to be retained for 30 years from the date of the first report. These records of tonsuiner allegations of personal injury or harm to health, reports of occupational disease or injury, or reports and complaints of harm or injury to the environment must be made available to any duly designated representative of the Administrator, and submit copies if so requested. Section 8(d) requires the manufacturer, processer or distributor, or anyone who proposes to do so, or anyone who has a copy of a health and safety study to submit a copy of the study to the Administrator. The Administrator may exempt certain types or categories of studies if he finds they are not needed for the enforcement of the act. Going one step further, Section 8(e) requires any manufacturer, processer, or distributor in commerce of a chemical substance or mixture who obtains information which reasonably supports the conclusion that such substance or mixture presents a subst-antial risk or injury to health or the environment shall immediately inform the Administrator, unless he has personal knowledge the Administrator is already aware of the information. SECTION 9. RELATIONSHIP TO OTHER LAWS ------- —8— As was mentionecr earlier, drugs, pesticides, alcohol, exploiives and -radiological materials are not regulated by TSCA. Also,.under the law, if a chemical is identified which may pose a risk to man or theenvironment, but may be more advantageously regulated under another law, that law or regulation will be given the opportunity to reduce the potential for harm to an acceptable level. Coimnon examples of such referrals have involved chemicals in the work place where OSHA worker protection standards have been put in place to protect employees from excessive exposure to a hazardous substance. A more recent instance where a chemical was found to cause a very high degree of risk, but the more appropriate law of choice for regulation was not suitable, involved hexavalent chromium use in open comfort cooling towers. The lung cancer risk from this chemical downwind from the open water cooling towers was estimated at 1:10,000. To regulate this chemical, emission and use regulations under the Clean Air Act were not reasonable. Instead, the regulation was prepared by the air program, published by the Office of Toxic Substances, and enforced by the regional toxics programs. Hexavalent chromium was banned from use in open systems and manufacturers and distributors were required to maintain records of sale and other record. requirements. SECTION 10. RESEARCH, DEVELOPMENT, COLLECTION, DISSEMINATION AND UTILIZATION OP DATA The Administrator has considerable flexibility to enter into research programs or contract for programs which will generate data retrieval systems or animal health data. The administrator may consult with the Secretary of Health, Education and Welfare, and heads o cther appropriate departments and agencies as neccss rv. E. amples of this type of research is the joint funding a! the National Institute for Cancer Research which is cofunded be:ween the Agency and the FDA. Joint activities with the Agen -a for Toxic Substances and Disease Registry, a part of the Centers fcr Disease Control, but funded by EPA, generate data bases and toxiCs profiles for a great many substances. Coordination and exchange of information is promoted at all levels of government, including state agencies. Training of federal laboratory and technical personnel is the final aspect of the agency’s efforts to create more complete and accurate information. SECTION 11. INSPECTIONS AND SUBPOENAS The regional programs have their greatest level of activity in compliance monitoring and enforcement efforts. Any duly designated representative of the Administrator may inspect any establishment, facility, or other premises in which chemical substances or mixtures are manufactured, processed, stored, or held before or after distribution in commerce, and any :onveyance being used to transport chemical substances, ------- 9 mixtures or such article:3 in connection with distribution in cómmerce. Credentials a:id a proper written notice of inspection must be presented to the owner, operator or agent in charge -of the premises or conveyance being inspected. The inspection need only meet the standards of reasonableness as to time, place and length. An inspection may extend t.o all things, physical and documentary, bearing on the requirements of the act. The inspection may not extend to financial data, sales data (other than shipment data), pricing data, personnel data, or research data (unless by rule or required by the Act) unless the nature and extent of such data are described with reasonable specificity in the written notice of inspection. Examples of inspections which are conducted by the regional toxics inspectors include PCB inspections, Hexavalent Chromium use inspections, CFC use inspections, sections 5 and 8 inspections and in some regions, audits of laboratories are conducted to assure the proper generation of data as required under a section 4 rule and conducted in accordance with the TSCA Good Laboratory Practices regulations. Witnesses may be called by subpoena if the attendance and testimony of that person is required to carry out the mandates of the act. Documents, records, reports and answers to questions may also be required to be submitted. Failure to comply with the requirements of the subpoena will result in contempt of court charge being filed against the person. One or two unique things about this section. Even though th inspections can (and occasionally are) be conducted by a stat inspector, there is no provision in the act for state enforcement. Only EPA can take an enforcement action. Some states have duplicated the federal statute at the state level in an attempt to regulate their own investigations, but the number is quite small. SECTION 12. EXPORTS; SECTION 13. IMPORTS. Sections 12 and 13 deal with the export and import of chemicals into and Out of the United States and the conditions under which such movement in commerce is allowed. TSCA will generally not apply to an exported chemical so long as there is not some order for testing or other evidence the chemical may cause harm to health or the environment. If such evidence exists for a chemical which is to be exported, the exporter must notify the agency so that the country of import may be made aware of the chemical’s hazards. Any chemical substance or mixture seeking entry into the United States must be in compliance with all TSCA regulations. A certification statement is required stating the chemical is in ------- 10 compliance, or a statement which states the chemical substance or article is not subject to TSCA, which would imply it is subject to another act (e.g. FIFRA, FDCA etc.). A Memorandum of Agreement is in effect with the U.S. Customs Service for primary enforcement of chemical movement into and out of the United States. Outgoing chemicals are checked for clearance to the foreign port, and incoming chemicals are checked for the appropriate certification statement required by TSCA. This statement is limited to one of two wordings. The first is for use on a chemical subject to the act which is properly entered on the TSCA Inventory. The importer must sign the following statement. “I certify that all chemical substances in this shipment comply with all applicable rules or orders under TSCA and that I am not offering a chemical substance for entry in violation of TSCA or any applicable rule or order under TSCA.” This certification is also required for any microorganism which is imported into the territory of the United States. If the chemical substance is regulated by FDA, FIFRA, Alcohol, obacco and Firearms (ATE) or the Nuclear Regulatory Commission tNRC), the following statement may be used: “I certify that all chemicals in this shipment are not subject to TSCA.” SECTION 14. DISCLOSURE OF DATA. Except for specific actions in the performance of official duties, law enforcement actions, for the protection of health or as a part of a (judicial) proceeding, it is unlawful for any employee of the United States or contractor to disclose any information obtained as a result of activities or requests under TSCA. Information obtained from a health and safety study may be released. However, other information, for example that which deals with processing of the chemical may not be disclosed. The manufacturer, processor or distributor in commerce may designate which information is believed to be confidential. Specific actions on the part of the agency are required before such data may be released. A maximum $5,000.00 fine and one year imprisonment constitutes the maximum penalty for divulging such information. SECTIONS 15 & 16. PROHIBITED ACTS AND PENALTIES There are only four prohibited acts under TSCA, but they are ------- —11-. pretty all inclusive. It is illegal for any person to 1) fail or refuse ta comply wit t any rule, order or requirement under sections 4,5, and 6; 2 use a chemical in violation of the act either knowingly or if knowledge should have been known; 3) fail or refuse to maintc in records, reports notices, etc. and to refuse access to tho,;e records; and 4) fail to permit entry for inspection. TSCA has been given the same presence under federal law as FIFRA. A warrant is not required for entry. The uniqueness of the law, the chemicals being regulated, and the ability to rapidly hide or cover up violations are viewed by the court as suffic Lent reason to allow immediate entry for routine inspections. If the entry is denied, an administrative warrant for cause may be obtained. The maximum civil penalty under the act is $25,000 per day per day of violation. Penalty policies are used to modify the penalty based on gravity and extent. A knowing and willful violation constitutes a criminal misdemeanor and may subject the violator up to one year’s imprisonment as well as the dollar penalty. SECTION 17. SPECIFIC ENFORCEMENT AND SEIZURE. Through the federal district court system the agency can obtain restraining orders to bar the actions of a person prohibited by sections 5 or 6. The agency can also compel the manufacturer or distributor to do certain activities required under the act or s iè cific actions by order. Procedures are given for the conduct of civil actions or seizure. Very seldom is seizure used, however, as it is generally more difficult for the agency to divest itself of an item after it has seized it than for the person who is/was originally responsible for the chemical substance or article. SECTION 18. PREE} TION. This section is often misunderstood. In effect the section says a state can do what ever it wants as long as it is the same as TSCA, does not countermand any TSCA rule, and does not interfere with the interstate commerce of the chemical substance. There has not been a great deal of activity at the state level to enact sweeping commercial chemical legislation. SECTION l9 JUDICIAL REVIEW. A provision exists within TSCA which allows any person to file a petition seeking judicial review of a new rule within 60 days of promulgation. The petition must be filed with the United States Courts of Appeals for the District of Columbia, or the district in which the person lives. The Courts of Appeal have exclusive jurisdiction of any action, with the exception of an ------- 12 enforcement action. Transcripts, records and modifications may be suggested’ and/or made to the rule. Following submission and review of all additional data, a determination is made to affirm, or set aside the regulation. It is possible for either party in a suite to appeal the decission all the way to the Supreme Court. Reasonable costs of the suit and attorney fees may be awarded to the party if deemed appropriate. SECTION 20. CITIZENS’ CIVIL ACTIONS. Any person may commence a civil action against any person, the United States, or other governmental agency who is alleged to be in violation of the act, or any rule promulgated under section 4, 5, or 6, or any order issued under section 5. A person may also take action against the Administrator to compel the Administrator to perform any act or duty under the law which is not discretionary. Suit cannot not be initiated to restrain a violation of the act, or rule or order under the Act until 60 days notice is given. No action may be commenced if the administrator (read agency) is diligently prosecuting a proceeding for the issuance of an order under section 16(a)(2) (an enforcement action). SECTION 21. CITIZENS’ PETITIONS. There have been at least two occasions here in Region IV where a citizens’ group has filed a section 20 petition which did not have slanding. There are only a certain number of situations where petitions are allowed. A petition may be used to repeal a rule under section 4, 6, or 8 or an order under section 5(e) or 6(b)(2). The petition must be filed with the administrator who has the option of holding public hearings or other investig- ation as necessary to determine if the petition has merit and should be granted. A response to the petition must be made in the Federal Register within 90 days unless an extension of time is requested. Under certain conditions the petitioner may commence a civil action to initiate a rule making in an appropriate United States District Court. SECTION 22. NATIONAL DEFENSE WAIVER. The Administrator may waive compliance with any provision of the Act upon the request and determination by the President that the waiver is in the interest of national defense. Such a waiver may not be released to the public if it would be contrary to the interest of national defense. SECTIONS 23. EMPLOYEE PROTECTION A whistle blower provision is in the act to protect employees against adverse actions which might be brought against an employee because the employee was in some manner involved in an investigation or action under the act. The Secretary of Labor ------- 13 is empowered to conduct the investigation and determine the appropriate remedy. Back pay, benefits, compensatory damages and exemplary damages m y be ordered by the Secretary. A provision also exists fcir a person to obtain a review of an order where the employe::, or employee, has been adversely affected by a rule or order. The petition must be filed within 60 days of the order. SECTION 24. EMPLOYMENT BENEFITS. TSCA is known as a risk—benefit law. A rule or order must be able to demonstrate a greater good to be achieved than economic cost to society. The Administrator is obliged to continually evaluate the potential effects upon employment of any action which might be taken under the act. When an employee alleges an adverse effect or potential for adverse action because of a rule, order, or requirement under sections 4, 5, or 6 to the Administrator, he shall conduct an investigation to determine the merits of the complaint. The Administrator will make a report on the results of the investigation, but there is no provision for repeal or amendment of the rule or order. SECTIONS 25 THROUGH 31. The last six sections of the act deal primarily with administrative issue concerned with conduct of studies, appropriations and state grants. The grant program is worthy of some’Uiscussion. The introductory sentence to the section states any state program is for “the purpose of complementing (but not reducing) the authority of, or actions taken by, the - Administrator under this Act, the Administrator may make grants to States for the establishment and operation of programs to prevent or eliminate unreasonable risks within the States to health or the environment which are associated with a chemical substance or mixture...” Although enforcement is not directly mentioned, most grants involving PCBs have been for the purpose of enforcement inspections. Asbestos grants have been under Title II of TSCA as separate federal acts, or also involved a degree of enforcement activity. There has been at least one suit by a private company attempting to nullify the use of state inspectors for PCB violations. Within Region IV a PCB cooperative enforcement project grant exists with Kentucky. Asbestos grants of various types are in effect in all eight states. SUMMARY In recent years, several people including the Administrator and Assistant Administrator for the Agency have made the statement that the Toxics Substances Control Act is the strongest environmental law on the Agency’s long list of statutes. When one considers the potential of this law to regulate every facet of the chemical industry through the regulation of individual ------- 14 chemicals, the law does have awesome potential. It can litterally dictate every aspect of a chemical’s existance, even to a greater degree than how pesticides are currently regulated under FIFRA. Under FIFRA there are no specific regulations concerning the manufacturing of the product. Until it is “packaged, labeled and released for shipment...” FIFRA and the pesticide inspector have little control of the chemical. TSCA, on the other hand can address manufacturing controls as well through rule or order. The impact of TSCA will become much more noticeable in years to come. ------- B ------- UNITED STATES ENVIRONMENTAL PROTECTICN AGENCY _____ WASHINGTON. -D.C. :0460 -- i FR 22 :eei E CCE3 . NC L STANCES SO—l2 ! 0P ANDt5M SZJBJECT: Coin uter-Generated ?C3 Records Jan Bearden, Chief Toxics Enforcement Policy Branch (EN-342) Tony Baney, Chief 1 Chemical Regulation Branch (TS -798) TC: Juliane Matthews Region 10 Assistant Regional Counsel Your memorandum of February 11 asked whether there are Agency enforcement policy considerations when a facility keeps its annual documents on a computer file, and only generates a hard copy upon request by the EPA inspector. Our review of the rule indicates that the’ Agency did not intend to specify exactly how the annual documents are supposed to be kept. The premise of your question is that these facilities are able to produce the printed documents at the. time of inspection. It would appear in that case that merely keeping the documents in the form of an electronic file does not constitute a violation of the rule. The key to complying with the rule is to have all annual documents required in 40 CFR Part 761.180 available for inspection upon request by the Agency inspector. If a facility chooses to maintain its documents on a computer file, it could be subject to an enforcement action if the computer is “down” on the day of inspection, or the operator is not available to retrieve the file. The rule states that the, documents “shall be available for inspection” and that “each owner or operator of the facility subject to these requirements shall know the location of these records.” Failure to produce a required document at the time of inspection is a violation of the ‘rule. It would not be sufficient for a facility owner or operator to simply state that they have their documents on file, but that for some reason or another the file cannot be retrieved. Otherwise, anyone could simply say they maintain their documents, feign computer trouble P ted on Recyc c ccr ------- at the time cf insteczi n, and r duce a ew dccument f:r z e 1nsPect r at some later z .rne. SimilarlY, the rule does not specify the form cf raccr s f:r “isual leak ins eczicns under Section 751.30. If a facili:-, chooses to ccmtuter.ze those records, the same concerns extresse above will a c1y. In sulnmar7, keetinc annual dccu ents and insDec :icn rec:r s cr. a commuter file is nct a v claticn of the CE rules. : cweve:, failure to have such documents and records available at the zitie of inspecticn is a violation. We recommend that “hard” cc ies f all documents and records be kept to ensure that they are available at the time cf inspection. We hope that we have answered your question. If you would like to pursue this question further, there may be a good opportunity to do so during the April PCB Seminar. Mr. Cary Secrest (FTS 475—8660) is the contact on this issue and is open for suggestions if you would like to raise this for discussicn there. cc: Regional Branch Chiefs Regional Counsel Mike Walker, CE Jim Nelson, OGC ------- C ------- • UNITED TATLS NVI c•N .1ENr L O L .l . T.:... . jj2fl909 M EMORANDUJM SUBJECT: TSCK § 5 and 8 Concurrence Prec.ess FROM: Michael F. Wood, Director Y” - - ’ Compliance Divisioi / Of f ice of CompliancbMonitorin I’, / ts” Michael 3. Walker • ( I L.( b 1 -” - Assistant Enforcei i t Counsel Toxics Litigation .Division TO: Addressees The Toxic Substances and Control Act (TSCA) section 5 and 8 program has been returned to Regions I, IV, VI , VII, VIII, IX, and X. During the past four fiscal years, this program was implemented by the National Enforcement and Investigations Center. Although the program has been returned to the these Regions, Headquarters will retain its usual oversight role until these Regions have gained a measurable degree of experience with the statute, reguLations, and enforcement response policies. In 1986 and 1988, EPA Headquarters substantially revised the TSCA § 8, 12, & 13 and TSCA § 5 Enforcement Response ‘olicies (ERP), respectfully. Both of these ERPs require tha Regions to obtain Headquarters’ concurrence prior to initiating and completing TSCA § 5 and 8 enforcement actions. Attached for your reference are the procedures for requesting Headquarters’ concurrence and for relaxing the ERP concurrence requirements. These procedures establish a process to rapidly respond to your requests. Our ultimate goal is to relax the cortcurrence requirements as soon as each Region gains sufficient experienc, in the issuance and settlement of cases in accordance with the appropriate ERP. We are committed to working closely with your staff - both technical and legal - tc maintain the momentum of this important enforcement program and remajn ready to assist you. Please ensure that these procedures are made available to all staff members who are enforci.ng this important reporting provision. Attachments 000001 ------- —2— AddreSSeeS: - Director, Air Management Division; Region 1 Director, Environmental Services Division; Regions 2, & 5 Director, Hazardous Waste Management Division; Region 3 Director, Air, Pesticides and Toxic Management Division; Region 4 - Director, Air, Pesticides and Toxics Division; Region 6 Director, Air and Tox .c Substance Division; Regions 7, 8, & 10 Director, Air Management Division; Region 9 Director, National Enforcement and Investigations Center Regional Counsel; Branch Chiefs and Acting Branch Chiefs: Susan Studlien Region I Wilkie Sawyer Region II Elizabeth Spencer Region III Bill Anderson Region IV Michael Smith Region V Jim Turner Region VI Bob Patrick Region VII Christine Phillips Region VIII Nina Spiegelman Region IX Deborah Hilsman Region X ------- TSCA § § 5 & 8 CONCURRENCE PROCEDURES PurOOSe The purpose of this document is to outline: 1. The procedure for obtaining Headquarters concurrence on Regional Toxic Substances Control Act (TSCA) section 5 and 8 ComplaintS and Consent Agreements. 2. Eeadquarters’s and Regional responsibilities. 3. The procedure for obtaining relaxation of these concurrence requirements. Adherence to these procedures will ensure timely concurrence on Regional complaints and settlement agreements, arid relaxation of tnese requirements. Contacts : he Headquarters concurrence process requires an independent review by two Offices, the Office of Compliance Monitoring (0CM) and the Toxics Litigation Division (TLD) of the Office of Enforcement and Compliance Monitoring (OECM). Both of thes. offices have assigned an individual to act as your regional coordinator. Page 4 of this memo is a current list of CM’s case support officers and TLD attorneys and their regional responsibilities. Your regional coordinator in the Case Support Branch of 0CM has been designated as the Headquarters contact point for obtaining case concurrences and relaxation of these requirements. All, requests for concurrence and relaxation of concurrence must be sent to: U.S. E.P.A. Headquarters Regional Coordinator (e.g., John Foley, region IV) Case Support Branch (EN-342) 401 H. Street, S.W. - - Washington, D.C. 20460 Your regional coordinator is responsible for receiving, tracking, and processing your concurrence requests. Each request for concurrence will be tracked in a database. Following the OCX case support officer’s review, the concurrence request will be forwarded to the appropriate TLD regional coordinator. In the event you have questions concerning these procedures or the status of a request, you are encouraged to call, your 0CM or TLD regional coordinator, as appropriate. During settlement negotiations, Regional personnel should also consult with their ippropriate regional coordinators concerning settlement 000003 ------- TSCA 5 & 8 CONCURRENCE JCEDURES ose : - The purpose of this document is to outline: i. The procedure for obtaining Headquarters concurrence on Regional Toxic Substances Control Act (TSCA) section 5 and 8 Complaints and Consent Agreements. 2. Headquarters’s and Regional responsibilities. 3. The procedure for ‘btaining relaxation of these concurrence requirements. Adherence to these procedures will ensure timely concurrence on Regional complaints and settlement agreements, and relaxation of these requirements. Contacts : The Headquarters concurrence process requires an independent review by two Offices, the Office of Compliance Monitoring (OCX) and the Toxics Litigation Division (TLD) of the Office of Enforcement and Compliance Monitoring (OECM). Both of these offices have assigned an individual to act as your regional coordinator. Page 4 of this memo is a current list of OCM’s case support officers and TLD attorneys and their regional responsibilities. Your regional coordinator in the Case Support Branch of 0CM has been designated as the Headquarters contact point for obtaining case concurrences and relaxation of these requirements. All requests for concurrence and relaxation of concurrence must be sent to: U.S. E.P.A. Headquarters Regional Coordinator (e.g., John Foley, region IV) Case Support Branch (EN-342) 401 H. Street, S.W. - - Washington, D.C. 20460 Your regional coordinator is responsible for receiving, tracking, and processing your concurrence requests. Each request for concurrence will be tracked in a database. Following the ocx case support officer’s review, the concurrence request will be forwarded to the appropriate TLD regional coordinator. In the event you have questions concerning these procedures or the status of a request, you are encouraged to call your 0CM or TLD regional coordinator, as appropriate. During settlement negotiations, Regional personnel should also consult with their appropriate regional coordinators concerning settlement ------- —2— proposals which are not explicitly addressed in the TSCA § 5, 8, 12, & 13EflforCement Response Policies (ERP). Another important contact for the Regions is Teresa Little in the Compliance Branch of 0CM. Teresa is responsible for servicing the Region’s requests for copies of submitted TSCA 5 & 8 documents and obtaining certified statements. Her mail code is (EN—342), and her telephone number is (8-382-7835). Concurrence Procedures and Responsibilities : 1. All enforcement actions and terms of consent agreements must be submitted to EPA Headquarters, in writing, for review and concurrence prior to filing these documents with the Regional Hearing Clerks. 2. The concurrence request (CR) package must include a. the appropriate concurrence request form, b. the inspection report. c. completed IMD certified statements concerning the Respondent’s TSCA § 5 or 8 reporting status, and (if applicable) the Inventory Status of suspected “new” chemical substances. d. the draft complaint. 3. Failure to supply the iterns noted above, constitutes an incomplete package and HQ will request resubmission of the CR package. If a package is complete, HQ may contact the Region to discuss additional documentation issues. 4. o Attachment A is a copy of a concurrence request form for the initiation of an enforcement actIon. o Attachment B is a copy of -a concurrence request form for concluding an action. o Attachment C is a request for a certified statement. Requests for certified statements must be sent to Teresa Little for processing. She will track your request and send the completed certified statement to the requestor. In order to have a completed certified statement in hand at the time a CR package is being compiled, HQ suggests that a certified statement request should be submitted soon after each inspection which uncovers a potential violation. Depending on the results of the certified statement, the Regions may need to obtain an updated certified statement at the time the case settles or proceeds to Hearing. 000005 ------- —3— 5. The Regional Program Office must have the CR package reviewed and agreed to by Regional counsel prior to its submission to Headquarters. Further the Regional Program Office and Regional Counsel are jointly responsible for ensuring that the alleged violation(s) have been adequately documented 6. Headquarters will review the Complaints and terms of the Settlement Agreements for their adherence to the TSCA § 5 & 8 Enforcement Response Policy, and the filing requirements of 40 C.F.R. Part 22.14. Headquarters will respond to each request within 28 calendar days from the date of receipt. The 28 day clock does not begin until a complete CR package has been submitted. Rasubmission may be required if the CR package is incomplete or incorrect . 7. A Region may not file a Complaint or Consent Agreement with the Regional Hearing Clerk until Headquarters has concurred on the filing of the document. Concurrence Relaxation Process : Each Region may request relaxation of the concurrence requirements on an activity-by-activity basis. Once a Region has successfully issued five TSCA § 5 and five TSCA § 8 civil administrative complaints, the Region may request the relaxation of the case issuance concurrence requirement regardless of the settlement status of the cases. A separate request for relaxation of the concurrence requirement for case settlement may be submitted at a later date once any five cases have been successfully settled. An action has been successfully issued or completed when a Region has submitted and filed an action which conformed to the TSCA § 5, and/or 8, 12, & 1.3 ERP. Requests to relax concurrence for case issuance or settlement should be submitted to the Director of the Compliance Division, 0CM. A sample form memo to request relaxation for either complaint issuance or settlement of T$CA § 5 & 8 cases is provided as attachment D. HQ will process requests for relaxation within 28 calendar days from our receipt. ------- —4— QEGION REGIONAL COORDINATOR TELEPHONE # I MAIL CODES 1 Mary McDonnell (OCM/CSB) 382—4818 / EN—342 Marged Harris (TLD) 475—8696 / LE134P 2 Mary McDonnell (OCM/CSB) 382-4818 / EN342 Jon Silberinan (TLD) 475-8694 / LE-134P 3 Sanda Spencer (OCM/CSB) 382—4844 / EN—342 Jon Jacobs (TLD) 475-8689 / LE—134P 4 John Foley (OCM/CSB) 382—4119 / EN—342 David Batson (TLD) 475—9501 / LE—134P 5 Tony Ellis (OCM/CSB) 382—3705 / EN—342 Jon Jacobs (TLD) 475-8689 / LE—134P 6 Rose Burgess (OCM/CSB) 382—4328 / EN-342 Marged Harris (TLD) 475-8696 / LE-134P 7 Rose Burgess (OCM/CSB) 382—4328 / EN—342 Vincent Giordano (TLD) 475-8693 / LE—134P 8 John Foley (OCM/CSB) 382—4119 / EN—342 Vincent Giordano (TLD) 475-8693 / LE-].34P 9 John Foley (OCM/CSB) 382—4119 / EN—342 Jon Si1ber an (TLD) 475-8694 / LE-134P 10 John Foley (OC!4/CSB) 382—4119 / EN—342 David Batson (TLD) 475-9501 / LE-134P 000007 ------- TSCA § 5/8 CASE ISSUANCE: Submit t form along ith the Draft Complaint Inspection Report, and Completed Certified Statements Reauest for COnctirrence - Case Issua RespOfldeflt (Name & Address) Reaioflal Contacts Region: 1, 2, 3, 4, 5, name and tel. #L 6, 7, 8, 9, 10 Program Office: Telephone #: 8 — Counsel: Telephone #: 8 — Description of Respondent : Respcndent is a: (chemical mantifacturer) Date of Inspection? SIC code: Nature of Violation : (Failure to submit a PMN report for 2 chemical substances, substance not subject to TSCA §5(e) or (f) and was distributed to customers; and report for the Inventory Update Rule for 10 chemical substances): Gravity Based Penalty Calculations : ount 1: Hazard Assessment, Major, Level 3, 5 days, $75,000 count 2: Hazard Assessment, Significant, Level 3, 25 days, $250,000 Count 3: Significant, Level 1, 10 chemicals, one day only $170,000 Total ProDosed Penalty : $495,000 Issues of National or Precedential Significance: Recommended Action : Concur ____ Nonconcur _____ Concur ____ Nonconcur _____ Date: _______ Date: _______ Reason for nonconcurrence: Reason for nonconcurrence: Michael F. Wood, Director Frederick F. Stiehl Compliance Division Associate Enforcement Counsel Office of Compliance Monitoring f or Pesticides and Toxic Substances ATTACHMENT A ------- TSCA § 9/8 CONSENT AGREENENTS: i espondent: ReQuest for Concurreflce (Name and Address) •4e Settleme Docket No.: Filed: / Regional Contacts nam and tel. #) Program Office: Counsel: Gravity-Based Penalty Assessment: Region: 1, 2, 3, 4, 5, 6, 7, 8, 9, to Telephone 1: 8 - Telephone #: 8 - $ Rationale % Total Assessed Penalty: Documentation Other Settlement Terms : (include actions taken by the Respondent to come into compliance) Recommended Action : Concur ____ Nonconcur _____ Date: _______ Concur ____ Nonconcur _____ Date: _______ Reason for nonconcurrence: Reason for nonconcurrence: Michael F. Wood, Director - Compliance Division Office of Compliance Monitoring Frederick F. Stiehi Associate Enforcement Counsel for Pesticides and Toxic Substances 000009 Pro osed Penalty Reductions: Amount Percentage —S % —S % —S % ATTACHMENT P ------- - :.. j £N’ ON’ .’ 4 RC E ’,\ AG :. - — MEMORANDUM SUBJECT: Request for TSCA § 8 Certified Statement FROM: Sherry Sterling, chief Compliance Branch Office of Compliance Monitoring (EN—342) TO: Frank Caeser, Chief Confidential Data Branch Information Management Division (TS—793) Attached is a certified statement which will be used as evidence in a Regional Toxic Substances and Control Act (TSCA) § 8 enforcement action. The Facility’s name and address, the calendar year and chemical for which they were required to report has been supplied by the Region. The remaining information is needed from IMD to fully document the violative acts. Please send the completed Certified Statement to Teresa Little, and she will forward it to the appropriate Region. Attachment ATTACHMENT C ------- C TIpIED STAT K1IT i, Linda A. Travers, am the Director of the Information Management Division. The Information Management Division of the office of Toxic Substances is responsible for the receipt of forms submitted pursuant to section 8 of the Toxic Substances and Control Act. I certify to the following facts: EPA received an EPA Form from the Facility noted below and assigned this submission the Document Control Number listed below. DOCUMENT CONTROL NUMBER: POSTMARX DATE: FACILITY NAME: FACILITY ADDRESS: CALENDAR YEAR REPORTED CHEMICAL OR CHEMICAL CATEGORY NAME: Linda A. Travers, Director • Information Management Division Date ATTACHMENT C, PAGE 2 000011 ------- ENvlRQN\1EN __ r _ , MEMORANDUM SUBJECT: Relaxation of Concurrence to Issue and/or Conclude Civil Administrative Actions for violations of Section 5 of the Toxic Substances and Control Act (TSCA) FROM: TO:. Region Director Division Michael F. Wood, Director Compliance DiviSiofl Off ice of Compliance Monitoring (EN—342) This memorandum is to request the relaxation of the requirement to obtain Headquarters concurrence prior to the issuance (or settlement) of TSCA § 5 civil administrative actions. Region has successfully issued (or settled) the following administrative actions: Complaints Successfully Issued (or Settled) 1. In re: Docket #: i led: TSCA §5 violation(s): 2. In re: Docket #: filed: TSCA §5 violation(s): 3. In re: Docket I:- filed: TSCA §5 violation(s): 4. In re: Dccket #: filed: TSCA §5 violation(s): Tii . . aa. t . Docket #: filed: TSCA §5 violation(s): Each of these cases was issued (or settled) in conformance with the TSCA section 5 Enforcement Response Policy. Copies of the filed complaints, consent agreements and final orders were forwarded to our 0CM, Case Support Branch, Regional Liaison in accordance with standard operating procedures. - If you have any further questions concerning these cases or Region’s TSCA section 5 compliance program, please contact at FTS- . I look forward to receiving your favorable response. ATTACHMENT D ------- —3— Example 2 — EPA requested a company to submit any al- legations of effects attributable to chemical V. The company reported that no allegations of effects of any kind were made to them. An Inspector visited the com- pany 2 years later and found a file for chemical V which included 3 allegations of bird kills attributed to the chemical. - Failure to report, level 1, significant, 3 C CU fl t 5. $17,000 + 364 X $17,000 x 3 $154,134 180 Failure to report — (1 yr. cap) — $154,134 Example 3 — EPA requested a company to submit any al- legations of effects attrlbutable to chemical V. The company reported that no allegations of effects of any kind were made to them. A year later they contacted the Agency and informed us that they Just found 4 old al- legations of human effects attributable to chemical V and submitted the allegations within 10 days. Late submission, level 4, significant, 4 counts. $6,000 + 360 X $6,000 x 4 $72,000 180 Late reporting — 361 days x 4 - $72,000 Example 4 — An inspector visited a company and asked to see the company’s ISCA §8(c) fIles. The company informed the inspector that any allegations by workers were kept in the Individual workers personnel files. Failure to keep files In a manner prescribed by the rule, level 3, significant, one day assessment, no per day penalty. $10,000 Example 5 — An Inspector visits a company and when inspecting their TSCA §8(c) file discovers that the files are organ— Ized by the health effect rather than by the cause of the health effect. The files are otherwise In compliance with the rule. Failure to keep files In a manner prescribed In the rule, level 3, significant, one day penalty. $10,000 0031 1 ------- -4- TSCA §8(d ) Example 1 — A company submits a list of ongoing studies they are sponsoring but fails to list a study involving humans. EPA discovers the violation. Failure to report, level 1, major. - Discovered after 365 days — $75,556 $25,000 + 364 X $25,000 = $75,556 180 Discovered after 1,095 days - $176,944 Discovered after 2,000 days — $278,333 (5 yr. cap) Example 2 - A company submits late an animal study in the company’s possession during the Initial reporting period. Late reporting, level 4, significant. Reported to EPA after 365 days — $18,133 $6,000 + 364 X $6,000 = $18,133 ‘pp Reported to EPA after i,095 days — $42,467 Reported to EPA after 1,825 days — $42,467 (3 yr. cap) Example 3 — A company submits an animal study, EPA finds ad.. ditional reportable Information that the company Intentionally omitted from the submitted study report. False reporting, level 1, sIgnificant. Discovered after 365 days - $51,378 $17,000 + 364 X $17,000 = $51,378 ‘op Discovered after 1,095 days - $120,322 Discovered after 1,825 days $120,322 (3 yr. cap) Example 4 — A company submits a list of 9 ongoIng animal studies and later submits 10 studies. Late reporting of one study, level 4, signIficant. Submitted to EPA 365 days after list submitted — $18,133 $6,000 + 364 X $6,000 $18,133 180 Submitted to EPA 1,095 days after list submitted — $42467 Submitted to EPA 1,825 days after list submitted — $42,467 (3 yr. cap) ------- V. — ;• I UNITED STATES ENVIRONMENTAL PROTECTION AGENCY •c. WASHINGTON. 0 C 20460 . I 2 F Ic 0 P IflCIOCS ANO YO*IC SUSSTANCE5 ME MO P AN DUM SUBJECT: 015/0CM Joint Inspection Program Fiscal Year 1988, Second Quarter FROM: . E. Conroy IC, Director Office of Compliance Monitoring (EN—342 TO: Charles L. Elkins, Director Office of Toxic. Substances (TS—792) During the past several weeks, staff members from the Office of Compliance Monitoring (0CM) and the Office of Toxic Substances (OTS) have discussed the posslblillty of establishing a joint inspection program. The goal of this program is to provide a routine, practical, and “in—context” avenue for 015 personnel and 0CM Inspectors to exchange information. The means to accomplish this goal is to get OTS personnel out of the office and Into the field with the 0CM Inspectors. My understanding of this program is as follows: o 0CM will target the inspection, determine what particular OTS expertise would be most beneficial for the inspection, lead the inspection, and make the necessary arrangenents for a smooth and efficient inspectional trip. o 0CM will then forward the attached memorandum to the appropriate OTS Division Director for their approval. Once approved, the memo will be forwarded to OTS Office of Program Ianagement and Evaluation. o OTS will provide the funds needed for the OTS employee to accompany the Inspector. OTS will fund one Inspection trip per quarter per Fiscal Year. Therefore, funding for this program Is not required from Divisional or Branch travel accounts. 000013 ------- -2 I am enthusiastic about this program and wish to Initiate it this month. If you approve of the program as outlined above p1eas sign below, return a photocopy of this memo to me, and forward the attached memorandum to Linda Travers. Otherwise, if you have any reservations about this proposed program, please call me to discuss your concerns. approve of the joint inspection program outlined above. /7 4 (_ 1 / c 4 e / Charles 1. ElkIns, Director Office of loxic Substances Attachment cc: Janet P. Thompson, Director Office of Program Management & Evaluation Jan L. Lane, Chief Management Staff ------- $P 4 , UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON. D.C. 20460 L iiiiolt • - oFrici 0, P(1TiClO($ ANO Y0*IC IUISTANCES M EMO RAND U M SUBJECT: OTS/OCM Joint Inspection Program Fiscal Year 1988, Second Quarter FROM: Ken Shiroishi, Director Compliance Division 1” Office of Compliance Monitoring (EN—342) TO: Linda Travers, Director Information Management Division Office of Toxic Substances (TS—793) The Office of Toxic Substances COTS) and the Office of Compliance Monitoring (0CM) have recently agreed to sponsor a joint inspection program. Under this program 0CM will invite, on a quarterly basis, one OTS employee to accompany an 0CM inspector on an inspection trip. OTS has agreed to pay the travel expenses for the OTS employee. The purpose of these special inspections is to provide a routine, practical, and “in—context” avenue for OTS personnel and 0CM inspectors to exchange information. Under this program, the National Enforcement Investigations Center has requested that Mark Scoville accompany Inspector William Palmer to Rhode Island to conduct TSCA inspections of three facilities. The inspection trip will last 5 working days and will begin in either the last week of January or the first week of Feburary. The exact dates will be worked out between Mark Scoville and Bill Palmer. 000015 ------- —2— If you approve of this request, please sign below and forward this memo to Jan Lane (OPME). Jan will then coordinate with Mark Scoville to prepare his travel authorization. I approve of the above requested travel for Mark Scoville. Linda Travers, Director Information Management Division cc: Susan Vogt, Deputy Director Office of Toxic Substances Janet P• Thompson, Director Office of Program Management & Evaluation Dean Full, Chief Pesticides & Toxic Substances Branch National Enforcement Investigations Center -4 & - / ‘ ,_/_ // / / ------- Sri, TI UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 4 oO1 13W 8t 89 orrscc or Pt$TICID I ANO YOXSC SUUSTANCES MEMORANDUM SUBJECT: Amendment to the TSCA S5 Enforcement Response Policy FROM: John J. Neylan III, Director ‘ Policy and Grants Division Office of Compliance. Monitoring TO: Addressees This memorandum amends the TSCA S5 .Lni a.cejn.ent Response Po 11 cy by of apply t t1Te iii stances where a compa-nyif s submitted a Notice of Commencement in anticipation of production or importation, the event does not occur, and the company never does produce or import he substance.. This change has been made in response to numerous comments that the policy issued on August 5, 1988, created a large in- equity in penalty when a company submits a Notice of Commence- ment but does not produce a substance, as compared to a company that produces a substance without submitting a Notice of Com- mencement. In the first situation, the current ERP requires that the violation be charged as a false NOC and would subject the violator to per day penalties from the day the false NOC was submitted to the day of discovery of the violation with the potential of very large penalties. The provision to allow for per day penalties for each calendar day a falsification occurs, was created for those situations where t e falsification pre- vents the Agency from making a reasoned evaluation of the chem- ical substance. This is not the case for a false NOC. The chemical has been reviewed and mistakenly placed on the Inven- tory. A reasoned evaluation of the chemical substance has been made. Attached are the two pages affected by the change with the necessary revisions incorporated. These pages may be inserted into the TSCA S5 ERP in the appropriate places. If you have any questions concerning the revisions please contact David Stangel of my staff at 382—3477. Attachments ------- GRAVITY BASED PENALTY MATRIX Circumstances Extent A B C Major Significant Minor - Levels 1 125,000 $17,000 $5,000 High Range 2 $20,000 . $13,000 $3,000 3 $15,000 $10,000 $1,500 Mid Range 4 $10,000 $ 6,000 $1,000 5 $ 5,000 $ 3,000 $500 Low Range 6 $ 2,000 $ 1,300 $200 ------- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 AUG 5 o..ucc 0, PESTICIDES AND TOXIC SUSITANCES MEMORANDUM SUBJECT: TSCA $5 Enforcement Response Policy FROM: Phyllis E. Acting Director Policy and Grants Division Office of Compliance Monitoring TO: Addressees Attached Is the final TSCA 55 Enforcement Response Policy (ERP) which incorporates the comments received on the February 22, 1988 draft. A summary of the comments and the response to those comments are also attached. We appreciate the time and effort spent In reviewing the draft and providing the detailed c om men ts. The final ERP has been revised In the following areas: The policy now addresses all exemption categories found under 40 CFR Part 723. One major change is that failure to notify violations are treated differently. depending on what action the Agency may have taken on the chemical 1 i.e., chemicals which otherwise qualify for an exemption, versus those which go through PMN review without any con— cerns,and those chemicals which are possible candidates for a TSCA 55(e) or 5(f) actIon. The c lrcuustance levels for failure to notify violations and commercial use violations have been changed and com- mercial use violations associated with manufacturing are no longer treated as a separate violation when the manu- facturer Is the person who is commercially using the chemical. Exceptions are made when the number of days of manufacture and the number of days of processing or com- mercial use are disproportionate and In Imminent hazard situations. Genetically altered, naturally occurring and low risk genetically engineered microorganisms are now addressed in the ERP. oooo 7 ------- JUN 8 1989 AMENDED TSCA SECTION 5 ENFORCEMENT RESPONSE POLICY OFFICE OF COMPLIANCE MONITOR.ING OFFICE OF PESTICIDES AND TOXIC SUBSTANCES THE U. S. ENVIRONMENTAL PROTECTION AGENCY ------- —2— The UP takes Into account whether a substance remains at the site of manufacture or leaves the site of nanu— facture when determining the circumstances of the yb— 1 ation. A quick reference chart has been included as an attach— rnent so that a case preparation officer may 1 once he/she becomes familiar with the ERP, more quickly determine the penalty associated with a violation. Please be advised that extent determinations are not always based on pounds of chemical substance involved in a violation, and the quick reference does not Include the full dis- cussion on extent. The ERP has been reformatted by placing the Gravity Based Penalty Matrix after the extent section, so that a person using the ERP would determine the nature, circum- stances and extent of a violation and then turn to the matrix to determine the penalty amount. The section on Injunctive Actions has been expanded to clarify when injunctive actions should be considered. If you have any questions concerning the UP, please address them to David Stangel of my staff at 382—7825. Attachments 000019 ------- Charles ElJdns (T5—792) Susan ‘Jbgt (TS—792) Fralerick F. St1 il (LE-134A) ? rk Greei ood (LE- 132A) A. E. C iroy II (EN—342) C iie Misgrove Ke iiroishi Pftyuis Flaharty John 3. Neylan 111 Jerry Stuths t’ ure L i i Carison Jake P k izie tern Regicxial caipliarre Director I 14XL1S F. Gitto, Director ? xvin se stein, thief Air ) eiuit Division Pesticides & dc Substarres Br II Barbara ! tzger, Director &nest Regna • thief wi ital Services Div Pestici & !1 idc 3ibstarres Br III Ste t R. Wasser ig, Director Larry Miller, thief }b2 r J5 Waste )tbn it DiV ¶Ibxic & Pestici && II IV Wthston A. 9nith, Director Richard DiBose, thief Air, Pest. & ‘1 cics ngt . Div Pestici & 1 dc 3.tstaires Br V William H. Sarders III, Dir Phyllis Reed, thief jLUIII it31 Services Div Pesticides & cic &ibstarres Br VI Wiuian B. Hathaiiay, Dir Rebert Marrfly, thief Air, Pesticides & cic Div Pesticides & cic 9.ibstarres Br VII - William A. ratl1n, Director Leo A] rii n, thief Air aid dcs Division Pesticides & 1 dc &ibstares Br VIII Irwin L. Dieketein, Director Alvin Yorjce, Chief Air aid Division !I cic Substarres Brarh DC Jeffrey ZellcJwon, Director E vis Bernstein. thief ‘Ibxics aid br ste P nagai ’it Div Pesticides & ¶Ibxics Brarrh X Gary O’Neal, DiL -tor K eth Feigner, thief Mr aid cics Division Pesticides & lbxic Sibstarres Br cc: Michael Walker (LE—l34P) ! ‘ rgaret stker ( ‘15—788) ------- Response to Comments Comment One commenter requested that the definition of Notice of Com- mencement on page 2 of the ERP be amended to read: “Under 40 CFR 720.102, CPA requires that any person who commences the manufacture or importation of a new chemical substance for which that person had previously submitted a PMN, must submit a notice of commencement of manufacture or Import on or no later than 30 days after the first day of manufacture or import.’ Response The definition has been amended as requested. Comment One commenter requested that the first factor for calculation of the gravity based penalty on page 5 be amended to read: “Impact on the Agency’s mandate to evaluate the potential for human health or environmental effects of a new chemical sub- stance prior to Its production or import.” Response The first factor is amended as requested. Comment One commenter requested that on page 7, under Chemical Control Violations, “Commercial use of an illegally, produced substance. be amended to read: “Commercial use of a substance produced without a PMN or valid exemption.” Re ’sponse The ERP has been amended throughout to reflect this change. Comment A number of persons commented on the fact that not all exemption categories in 40 CFR 723 were addressed in the.ERP. Response The ERP has been amended to address violations of all the exemp- tion categories under 40 CFR 723. 000021 ------- —2— Comment One person commented that processing of an illegally produced chemical substance by the company tnat manufactured the sub- stance Is almost an inevitable part of the manufacturing pro- cess and that the previous policy of charging two counts when this occurs is unfair 1 Even If the substance never left the manufacturer’s control, the penalty essentially doubles because the manufacturer processes the substance. The commenter sug- gested that the ERP should charge only one count when a man- ufacturer produces and processes an Illegally produced sub- stance, namely failure to submit a PMN, but raise the cir- cumstance level when this occurs. Response The policy has been amendedto charge only one count when a manufacturer both produces and processes an illegal chemical substance, but raises the circumstance level one level when this occurs. However, there are certain exceptions described in the policy. Comment One person commented that while the policy did address genetic— ally engineered microorganisms, it did not address genetically altered, naturally occurring or low risk categories of organ— I sms. Response The discussion under extent has been amended to address genet- ically altered, naturally occurring or low risk categories of organi sms. Comment A number of cominenters asked for examples of how the policy is applied to various fact patterns. Response Appendix 1 has been added to provide the user of the policy with examples of how the policy is to be applied. Comment One person commented that the ERP allows environmental benefi- cial expenses to be deducted from a penalty where the action was requested but not required by EPA, but gives no similar allowance to a company that may undertake the same actions independent of any request by EPA. ------- —3— Response The ERP has been revised to allow credit pursuant to the TSCA Penalty Policy to companies that undertake environmentally beneficial actions. Comment A nt4mber of persons commented on the fact that the length of the ERP made it cumbersome to work with when trying to deter- mine a penalty. Response Two revisions have been made to address thl.s comment. First, the ERP has been reformatted. by placing the Gravity Based Penalty (GBP) Matrix after the Extent section, so that a per- son using the ERP would determine the nature, circumstances, and extent of the violation and then turn to the GBP matrix to determine the penalty amount. Second, a quick reference chart has been made so that a case preparation officer could use the quick chart to calculate the penalty, after they be- come familar with the revised ERP. Comment A number of persons had questions concerning the definition of certain terms used In the ERP and requested that the UP contain a definition of these terms. Response A definitions section has been added. Comment One commenter remarked that the terms “distribution to others,” “further processed for commercial use by the company,” “further processed by another firm,” “distributed to consumers,” and “released uncontrolled into the environment” are used as the basis for heavier penalties while the rationale for appli- cation of these terms was unclear. Response All the terms used as a basis for assessing heavier penalties show an increase in potential exposure to the chemical sub- stance by either workers, the public, or the environment. 000023 ------- 41; 5 TSCA SECTION 5 ENFORCEMENT RESPONSE POLICY OFFICE OF COMPLIANCE MONITORING OFFICE OF PESTICIDES AND TOXIC SUBSTANCES THE U. S. ENVIRONMENTAL PROTECTION AGENCY ------- TABLE OF CONTENTS INTRODUCTION - Summary of Rules/Requirements..... .. . . . . .. .. . .. . . 1 DETERMINING THE LEVEL OF ACTION Admi ni strative Civil Penalty... .. . . . . .. . . . . . . . .... ..... 2 Injunctive Actlon........... ... ..... .... . 3 Criminal Sanctions... ,....... •1e•• •1S • • •,, •,,• . . •. .. ... 4 ASSESSING A CIVIL ADMINISTRATIVE PENALTY SummaryofthePenaltyPolicy..........................5 Background... ..... . ..... . S.. S •• •• • •••.•. .... .... 5 •• 5 Applicabillty....................................... 6 Calculation of the Gravity Based Penalty........... 6 Mature.............................................. 7 Circumstances. ...... .. .. ... . . .. . . ....... .... •.... ... 8 E xtent.............................................. 13 G ravity............................................. 15 Per—Day Assessments.................. 15 One—Day Violations...... . .. . • . . . . ... ... .... . • • ... ..• 15 Imminent Hazard..................................... 16 Gravity Based Penalty...... . ...••..••. • . . . .. . . .. . .. . 16 Adjustlngthe Gravity Based Penalty................. 17 Voluntary Dlsclosure................................ 17 History of Prior Violation. .... .. .. .......... .... ... 19 Culpablllty......................................... 19 ExplanatIon ofthePenaltyPol lcy...................... 20 Nature. •.............. .......... •... • •..... .... ... 20 Clrcumstances...................................... • 21 Extent. .............. .... . 5• ••IS••SSSS ........ 22 Gravity of the Violation.. .... .... ....... ........... 25 Adjustment Factors.............,.................... 27 000025 ------- 1NT UDUCIION Section 5(a)(1) of the Toxic Substances Control Act (TSCA) requires chemical manufacturers and importers to notify EPA 90 days prior to manufacturing or importing a new chemical substance in the United States. EPA will evaluate the new chemical subsfance within 90 days based on the information supplied by the submitter. If the Agency finds that the infor- mation supplied Is insufficient to permit a reasoned evaluation of the health or environmental effects of the chemical substance and that in the absence of such Information the manufacture, distribution, use or disposal of the chemical substance may pose an unreasonable risk of injury to (tealth or the environ- ment, or that the chemical substance may be. produced in sub- stantial amounts which may result in significant human or environmental exposure, the Agency may issue an order under TSCA §5(e) to prohibit or limit the manufacture, distribution, use or disposal of the chemical substance. ISCA S5(a)(2) allows the Agency to identify uses of a chemical substance which EPA has determined are significant new uses and to require notification of those significant new uses. Certain exemptions from the full reporting and notification r .qu1rements are allowed under TSCA §5(h). These exemptions may be found at 40 CFR 720.30 through 720.38 and at 40 CFR Part 723. The major exemptions from notification are research and development, test marketing, small quantities (less than 1,000 kg per year), certain polymers and substances used in Instant photographic and peel—apart film articles. Failure to comply with the provisions of TSCA §5 Is a violation of TSCA §15 and subject to the remedies found in TSCA §16. Summary of TSCA 5 Requirements Premanufacturing Notification (PMN ) — Under TSCA §5(a)(1) and 40 CFR 720, manufacturers and importers of new chemical substances are required to submIt, 90 days prior to manufac- turing or Importing, a notice of their Intention to conduct such activittes as well as any test data in their posesslon or control 1 accordance with 40 CFR Part 720.50. ------- —2— Significant New Use Rules (SNUR ) — Under TSCA §5(a)(2) and 40 CFR 721, EPA specifies by rule the use(s) of chemical substances which it considers to be significant new uses. EPA must be notified prior to commencement of any significant new use. Notice of Commencement(PIOC ) — Under 40 CF 720.102, EPA re- quires that any person who commences the manufacture or Im— portatlón of a new chemical substance for which that person had previously submitted a PMN, must submit a notice of commencement of manufacture or import on or no later than 30 d,a’ys after the first day of manufacture or import. ISCA §5(e) Order — Under ISCA §5(e), If EPA determines that the information available in support of a PMN is insufficient to make a reasoned evaluation of the health or environmental effects of a chemical substance, EPA will issue an order imposing controls, restrictions or prohibitions on the manu- facture of the substance In order to address the concerns of EPA. TSCA §5(f) Order — Under TSCA §5(f), if EPK finds that the man- ufacture, Import, processing, distribution, use or disposal of a chemical substance presents or will present an unreasonaDle risk of injury to health or the environment before a rule promulgated under TSCA $6 can protect against such risk, the Administrator may Issue an immediately effective proposed rule to impose controls or restrictions to protect against such risk or may Issue an Order to prohibit manufacture, processing, or distribution in commerce. TSCA §5(h) Exemptions — TSCA §5(h) and 40 CFR 720.30 through 720.38 and 40 CFR 723 exempt certain substances and classes of substances from the full notification and reporting require- ments of TSCA §5. DETERMINING THE LEVEL OF ACTION Enforcement alternatives Include civil penalties, injunctive relief, criminal action or some combination of these actions. Notices of noncompliance are not appropriate for TSCA 55 violations. Administrative Civil Penalty An administrative civil penalty will be the appropriate response for most violations of these regulations. 000021 ------- —3— Concurrence Civil penalties are to be assessed according to this policy. Regional enforcement personnel must obtain written concurrence from the Office of Compliance Monitoring (0CM) of the Office of Pesticides and. Toxic Substances prior to initiating a civil admi ni strative penalty for TSCA 55 violations. Reductions for settlement purposes require the concurrence of 0CM as well and must be in accordance with the TSCA Penalty Policy and this Enforcement Response Policy. Each reduction must be based on the TSCA Penalty Policy or this policy and justified in the Consent Agreement and Final Order with specific dollar amounts attributed to each reduction. Headquarters may relax concurrence requirements on a Region by Region basisafter the Regions have gained experience with actions under these rules and this policy. Injunctive Action In most circumstances, a ISCA §16 admfnlstrative action will provide a complete and timely remedy for ISCA $5 viola- tions. However, certain cases may present the need for the types of injunctive relief available under TSCA §17 in addi- tion to TSCA §16 adminIstrative actions. Section 17 provides the U.S. District Courts with the juris- diction to: — Restrain persons from taking actions prohibited by TSCA §5 5, 6, and 15. — Compel persons to take actions required by TSCA. — Direct manufacturers, importers, or processors in violation of ISCA to: provide notice of the violation or risk of in- jury to, or repurchase the product from, the consumers of the violative product. — Seize any chemical substance manufactured, imported, pro- cessed, or distributed in commerce In violation of TSCA. ------- -4- It Is important to note that ISCA §17 does not require an Imminent hazard or recalcitrant respondent as a condition to its use. However, the Agency believes that the use of TSCA §17 should be limited to those Instances where a civil penalty action will not mitigate a hazardous situation, Is not likely to result in timely compliance, or where penalties alone do not provide a complete remedy. Injunctive action is appropriate in the following examples: • illegal production/use which presents a hazard to human health or the environment; • violations of TSCA §5(e) or 5(f) orders, Low Volume Ex- emptions, or Test Marketing Exemptions which involve the failure to use personal protective, equipment or chemical control measures; • contumacy, undue delay., or refusal of a violator to comply with TSCA requirements and regulations; or • repeat offenders for whom the penalty adjustments for past history of violations is unlikely to deter future violat1on . Criminal Sanctions Criminal sanctions pursuant to TSCA §16(b) are the most serious sanctions available for violations of TSCA §5. Accordingly, criminal sanctions may be sought in situations that, when measured by the nature of the conduct, the compli- ance history of the subject(s) and the gravity of the conse- quences to human health or the environment, reflect the most serious cases of misconduct. 000029 ------- —5— - ASSESSING A CIVIL ADMINISTRATIVE PENALTY Summary of the Penalty Policy Background - The ISCA Civil Penalty Policy 1 published in the Federal Register on September 10, 1980, establishes a system for deter— mfr.tng penalties In administrative actions brought pursuant to TSCA $16. Under that system, penalties are determined In two : ;; u To d penalty, the following factors affecting a violation’s gravity are considered: • The of the violation. • The E cunft&11’t s” of the violation. • The e flWt” or potential for harmthat could result from a given violation. These factors are incorporated into a matrix which allows determination of the appropriate gravity based penalty. Once the gravity based penalty has been determined, upward or downward adjustments to the penalty amount are made in con- sideration of these other factors: • 1 t$iy - • a11*ty-topay , • amity to COitTflue frbiiIfness, and s u ch...olhe r— i tatteY Ts -jUstTcrlway- req u I r e. ------- —6— The ISCA Civil Penalty Policy system provides a framework for the development of Individual penalty guidances for each rule promulgated under TSCA. This document sets forth Agency policy for the use of the Gravity Based Penalty Matrix to assess penalties for specific violations of TSCA $5 and regula- tions promulgated pursuant to this section. pplicability - This policy is Immediately applicable and should be used to calculate penalties for all administrative actions concerning TSCA §5 Instituted after the date of this policy. regardless of the date of violation. Pending cases should be reviewed to determine whether the penalty calculated under this policy is lower than the penalty in the civil complaint. If this policy yields a lower penalty, an amendment to the complaint should be made to substitute the lower penalty. This policy should not be used to raise penalties in existing actions. No case should be settled for an amount higher than the penalty which this policy would yield. Calculation of the Gravity Based Penalty Penalties for TSCA §5 violations vary depending on the nature, extent, circumstances and whether penalties are to be calculated as one—day assessments or per—day assessments. In establishing each of these, the Agency considered the following factors in a comparative manner: Potential for and/or the relative degree of harm to human health or the environment caused by failure to comply. This directly relates to the Impact on the Agency’s mandate to evaluate and control the poten- tial for human health environmental effects of a new chemical substance prior to its production or Import. • Potential exposure of the public or the environment to an unregulated new chemical substance. • Impact on the validity of the Inventory, which the statute mandates the Administrator to keep current. • Deterrent effect the penalty would have or the like- lihood that the penalty will deter future violations. 000031 ------- —7— Nature fl L f the TSCA violation depends on whether the violation re es to chemical control, control—associated data— gathering, or hazard assessment. It is important to make this determination first. Determining the nature of the violation is necessary prior to using the extent matrix. The following list places the violation types in their respective categories. 1) ChemIcal Control Violations • Noncompliance with TSCA §5(e) or 5(f) orders, rules, or injunctions and significant new use rules (those aspects dealing with the actual control of the substance, i.e., production, commercial use, disposal, production restrictions, etc.). • Noncompliance with research and development exemption restrictions (noncompliance with the adequate warning and supervision of a technically qualified Individual requirement). • Noncompliance with test marketing exemption restrictions (those aspects deal ng with the actual control of the substance). • Noncompliance with exemption restrictions under 40 CFR 723 (those aspects dealing with the actual control of the substance). 2) Control—Associated Data—Gathering Violations • Noncompliance with the recordkeeplng provisions of TSCA §5 orders, rules, or injunctions. • Noncompliance with the recordkeeplng provisions of exemption restrictions under 40 CFR 723. • Noncompliance with the recordkeeping provisions of the research and development and test marketing exemption restrictions. 3) Hazard Assessment Violations • All failures to notify EPA when such notification 7 is required by law. / /1 ) I. 5ft’ 1 :/P 5 • Withholding material information from or submitting false or misleading Information in a ISCA §5 notice or exemption request. • Commercial use of a substance produced without a PMN or valid exemption. ------- -8— • Noncompliance with the reporting provisions of TSCA 55(e) or 5(f) orders, rules, or Injunctions. • Any violation not listed previously. Circumstances Once the nature of the violation has been determined, the second step irrcalculating the penalty Is determining the c4.— cumstaflç , of the violation. The circumstances determination is based upon the probability that harm could have taken place — an a priori potential for harm to the environment or the Agency’s decisionmaking or ability to regulate, I.e., potential exposure to an unregulated chemical substance or harm to the Integrity of the Inventory.’ Any after the fact determination that harm did or did not take, place is irrele- vant to the initial circumstance level determination. The gravity based penalty matrix provides for six circumstance levels. Levels one and two represent the Agency’s determina- tion of circumstances where there exists a high probability of harm. Levels five and six represent circumstances of low probability of harm and levels three and four fall between these high and low probabilities. The circumstance level of a violationis designated in the following manner.. Please note that many of the levels refer to a PMN being subject to a TSCA 55(e) or 5(f) action. Please refer to page 22 for a further explanation of when a substance Is subject to a TSCA §5(e) or 5(f) action. Failure to Notif ! Failure to submit a PMN not subject to a TSCA §5(e) or 5(f) order or exemption when the substance was not distributed to others or further processed for commercial use by the company is a level 4 violation, per—day. Failure to submit a PMN not subject to a TSCA 55(e) or 5(f) or’der or exemption when the substance was distributed to others or further processed for commercial use by the com- pany Is a level 3 violatIon, per—day. Failure to submit a PMN when the substance is or would have been the subject of a TSCA §5(e) or 5(f) action but was not either distributed to others or further processed for commercial use by the companyTs a level 2 vIolation, per-day. Failure to submit a PMN when the substance is or would have been the subject of a TSCA §5(e) or 5(f) action and the substance was either distributed to others or fuF Fer processed by the company is a level 1 violatIon, per—day. I •7 OOOO ------- -9- Anended Failure tO submit a PMN for a chemical substance which would reet all requirements for a polyner exemption under 40 CFR 723.250, except that the company did not file for an exemption, will be assessed as a level i violation, per—day. Failure to submit a PMN for a themical substance which would meet all requirements for a polymer exemption under 40 CFR 723.250, except that the company did. not file for an exemption and the substance was furtner processed for commercial use, distributed to consumers, or released uncontrolled into the environment will e assessed as a level 4 violation, per—day. ‘ailure to submit a Notice of Commencement Is a level 3 ‘ iolation, one—day. Failure to submit a timely Notice of Commencement (early or late submission, up to 30 days prior to manufacture or 30 to 60 days after manufacture) is a level 6 violatIon, one—day. Failure to submit a timely Notice of Commencement (early or late submission, more than 30 days prior to manufacture or ‘ more than 60 days after manufacture) Is a level 4 vIolation, one—day. Withholding information or submitting false or misleading information with regard to a PMN, Significant New Use Notice, or exemption request Is a level 1 vIolation, per—day. Submission of a false Notice of Commencement Is a level 1 violation, one—day. Noncompliance with TSCA §5(e) or 5(f) Orders, Rules or injunctions ana 1gniTiCant New Use (uIes Violation of on—site restrictions is a level 2 vIolation, per—day. Violation of off—site restrictions where the substance was either processed by another firm or distributed to consumers or released uncontrolled into the environment is a level 1 Violation, per—day. Failure to submit a Significant New Use Notice when the sub- stance was ap distributed is a level 2 vIolation, per—day. Failure to submit a Significant New Use Notice when the sub- stance was distributed to consumers Is a level 1 violatIon, per—day. Violation of production ban or restriction is a level 1. violation, per—day. Failure to generate reports as required Is a level 2 violation, p e r — day. ------- -10— Failure to generate reports as required, where the substance was either processed by another firm or distributed to consumers or released uncontrolled into the environment Is a level 1 VIolation, per—day. Late submission of required reports where the substance was not distributed or processed is a level 4 violation, per—day. Late submission of required reports where the substance was either processed by another firm or distributed to consumers or released uncontrolled into the nvironment Is a level 3 VTolation, per—day. Withholding Information or submitting false or misleading information is a level 1 vIolation, per—da)t. Violation of the recordkeeping provisions where the firm produces the missing records within 5 days of a written EPA request is a level 4 violatIon, one—day. Violation of the recordkeeping provisions where the firm cannot produce the missing records withIn 5 days of an EPA request is a level 3 violation, one-day except as specified on page 26 of the policy. Commercial Use of a Substance Produced Without a PMN or Valid Exemption Commercial use violations will be charged In two circumstances: 1. Where a company processes or uses a chemical substance which it did not manufacture and it has reason to know Is not on the Inventory. 2. Where a chemical substance was manufactured or Imported ille- gally on just a few occasions and processed over a long per- iod of time, the substance would have been subject to a TSCA §5(e) or 5(f) order, and the activity could have caused substantial endangerment to health or the environment. Commercial us. violations will be assessed as follows: Violation where the substance was not processed by or dis- tributed to others after rece1pt bTthe user Is a level 4 violation, per—day. Violation where the substance was further processed by or distributed to others is a level 3 vIolation, per—day. Violation where the substance is or would have been the subject of a TSCA §5(e) or 5(f) actIon but was not processed by or distributed to others is a level 2 T lTiTon, per—day. 000035 ------- —11— Violation where the substance Is or would have been the subject of a ISCA 55(e) or 5(f) action and was either processed by others or released uncontrolled lntrThe environment is a level 1 violation, per—day. In cases involving Imminent hazard the Agency reserves the right to charge a manufacturer with both- failure to submit a PMN and illegal commercial use of the substance. Noncompliance with Test Marketing Exemption Restricttons Overproduction by 10% or less is a level 3 violation, per—day. Overproduction of more- than 10% would be charged as a failure to submit a PMN. Violation of exposure related, on—site restrictions is a level 2 violation, per—day. Violation of recordkeeplng provisions Is a level 4 violatIon, one—day except as specified on page 26 of the policy. Violations of the off—site control provlsio’ns of a TIlE where the substance was either distributed to consumers or was released uncontrolled into the environment Is a level 1 violation, per—day. Noncompliance with Research and Development Exemption Restrictions Violations regarding the labeling of the R&D substance where the substance was further processed by another firm is a level 2 vIolation, per—day. Violations regarding the labeling of the R&D substance where the substance was either distributed to consumers or was released uncontrolled into the environment Is a level 1 violation, per—day. Please note that any violation of an R&D exemption other than failure to adequately label the R&D substance, would cause the charge to be a failure to submit a PMN. Noncompliance with Low Volume Exemption Restrictions Violations regarding the notification of customers of the re- strictions on use of the substance Is a level 2 vIolation, per—day. Violations regarding the failure to notify EPA of any changes In site or use of the exempted chemical Is a level 2 viola- tion, per—day. ------- —12— Violations of the recordkeeping provisions of the low volume exemption Is a level 3 violation, one—day except as specified on page 26 of the policy. Vlo}ations of the 1,000 kg. production limit would be viewed as a failure to submit a PMN. Violations regarding the failure to maintain required exposure controls Is a level 2.vlolatlon, per—day. Noncompliance with the Instant Photographic and Peel—Apart Film Article Exemption Restrictions Failure to limit manufacturing and processing to site(s) listed In the exemption application is a level 5 violation, per—day. Distribution in commerce oruse of a peel—apart film article containing a new chemical substance prior to Its being cleared through the PMN process would be considered a failure to submit a PMN and subject to the penalties thereunder. Failure to follow the conditions of manufacture for instant photographic or peel—apart film articles where the substance would not have been subject to a TSCA §5(e) or 5(f) order is a level 2 violatIon, per—day. Failure to follow the conditions of manufacture for Instant photographic or peel—apart film articles where the substance would have been subject to a ISCA §5(e) or 5(f) order is a level 1 violation, per—day. Violation of the recordkeep lng provisions of this exemption Is a level 3 vIolation, one—day except as specified on page 26 of the policy. Noncompliance with Polymer Exemption Restrictions Violations regarding the submission of test data with the exemption application is a level 1 vIolation, per—day. Violations of the recordkeeplng provisions of the polymer exemption Is a level 4 violation, one—day. All other violations of the polymer exemption would be charged as a failure to submit a PMN. Product Ion Production of a chemical substance not subject to a TSCA §5(e) or 5(f) order or exemption after submission of a PMN but prior to the expiration of the PMN review period is a level 3 violation, per—day. 000037 ------- —13— Production of a chemical substance after submission of a PMN but prior to the expiration of the PMN review period when the substance becomes or would have been the subject of a TSCA 55(e) or 5(f) actIon or the substance was distributed to consumers is a level 2 violTtlon, per—day. Production of a chemical substance prior to the expiration of the PMN review period when the substance becomes or would have been the subject of a TSCA 55(e) or 5(f) action and the substance was distributed to consumers Is a level 1 violation, per—day. Other Violations Any other violation not listed above isa level 4 vIolation, per-day. Extent The third step in selecting the base penalty for a spe- cific violation from the matrix Is to determine the violation’s position on the extent axis. Extent is based on the amount of substance Involved in the violation and the nature of the violation. The following table Is to be used to determine the extent of a violation. EXTENT MATRIX Nature Extent Level A B C Major Significant Minor Chemical >2,500 lbs >250 lbs to 2,500 lbs >0 to 250 lbs Control ‘1,134 kg ‘113.4 kg to 1,134 kg >0 to 113.4 kg Control— >10,000 lbs >1,000 lbs to 10,000 lbs ‘0 to 1,000 lbs Associated >4,536 kg >453.6 kg to 4,536 kg >0 to 453.6 kg Data— Gathering . Hazard >7,500 lbs >750 lbs to 7,500 lbs >0 to 750 lbs Assessment >3,402 kg >340.2 kg to 3,402 kg >0 to 340.2 kg * Note exceptions listed on page 14 and 15 under Notes for determining extent. ------- -14— Notes for determining _ extent 1) ProductIon records will generally serve as the extent basis in the following violation categories: • All fail ures to notify EPA when such noti ficatlon Is required by law. • Noncompliance with TSCA §5(e) or 5(f) orders, rules, or injunctions. • Noncompliance with exemptions under 40 CFR Parts 720 and 723. I cbealses S d t he. ma us-ted. 1 f t ha 1 r mJ ovi d a-wh1 N can e t’o dete m1 ne j thé e xtent. If the underlying viäiatlve conduct iés nót relate to production, another more appropriate basis should be employed to determine extent. If, for example, the violator disposes of 5,000 pounds of the substance in violation of the terms of a TSCA §5(e) order, then the amount of the substance disposed, as evidenced in disposal records,ls the basis of the penalty. 2) The b’as ir’ä/ exter in a commercial , (se vioia?iion wi4 be the amouht of t4legally produced.lsubstance’ process ed or/used by the v1ó Iator on a given day. 3) If the records specified above are unavailable, the penalty is to be assessed from those records that are available If possible or at the major extent level. 4) ViolatIons for withholding information, submitting false or misleading Information, or failure to submit reports required by a TSCA §5(e) or 5(f) order, rule or Injunc- tion do not lend themselves to extent determinations based on production amounts. For the purposes of de- termining per—day penalties under this ERP, if the the study which Is the subject of the violation in- volved human monitoring data, the extent Is major. If tha study which is the subject of the violation involved animal laboratory data, the extent Is significant. If the study involved physical or chemical properties or environmental fate data, the extent is minor. This Is consistent with the TSCA §S8, 12, and 13 Enforcement Response Policy. 5) ViolatIons involving genetically engineered microor- ganisms do not lend themselves to extent determinations based on the matrix, due to the extremely small amounts involved. These microorganisms may have the ability to reproduce, creating a larger environmental hazard. 000039 ------- —15— Therefore, any violation Involving a genetically engineered microorganism will be considered major in extent. Likewise, violations Involving any genetic- ally altered or naturally occurring organisms subject to a SNUR or TSCA 55(e) order will be considered major tn extent. In the event the Agency identifies low—risk categories of organisms, violations involving low—risk organisms will be considered significant. 6) All Notice of Commencement violations will be considered major in extent. Gravity Gravity, as used in th1 s UP, is dependent upon the nature, extent and circumstances of the violation. Per—Day Assessments Where per—day assessments are provided for In the Circum- stances Level section, the base penalty is calculated for the first occurrence of a violative activity and assessed for each ddy of subsequent occurrence. For example, a manufacturer or importer is responsible for notifying EPA prior to iroduct1on or import- ation of a new chemical substance. Each day of production or importation of a new chemical substance In violation of the notification requirements of TSCA $5 constitutes a new viola- tion. A day of violation is counted for each day a chemical substance is produced regardless of the number of batches pro- duced on a given day. The total amount produced on a given day would be used when determining extent. If production of a chemi- cal substance takes place over a number of days before the manufacturing process Is complete, production occurs only when the manufacturing process has been completed. Likewise, a manu- facturer or importer subject to an order, rule or injunction under TSCA $5 which directs him to dispose of the substance or wastes in a particular manner, is in violation for each day dis— posal occurred contrary to the requirements of the order, rule or injunction. Illegal commercial use violations are assessed under the same principles. Commercial use violations, however, are based on the amount of Illegally produced chemical substance used. Per—day penalties assessed on a daily basis (I.e., calendar days vs. days of actual production) are generally reserved for violations of the data—gathering provisions of,TSCA 55 where the Agency needs the data to assess the risks presented by a chemical substance, or situations involving Imminent hazard. One—Day Violations Violations of the recordkeeping provisions of TSCA 55 are assessed on a one—time basis only except where compliance cannot be determined or noncompliance was intentional. See pages 22 and 26 for a further discussion of these issues. ------- —16— Imminent Hazard Upon review of the facts surrounding a violation, the Agency may make a finding that continued production, sale and distribution of a substance may present an imminent haz&rd to health and the environment. In the event of such a finding, the Agency may take steps to halt further production, sale and distribution of the product as well as assess the maximum pen- alty of $25,000 per day for each calendar day the exposure from manufacturing and/or commercial use occurred. Thus, if the Agency determined that exposure to a substance found to be an imminent hazard occurred for 90 days, the penalty would be 90 X $25,000 or $2,250,000. Gravity Based Penalty The Gravity Based Penalty (GBP), a function of the nature, circumstances and extent ot each violation, is to be determined by using the following matrix: GRAVITY BASED PENALTY MATRIX Circumstances Extent A B C Major Significant Minor Level S 1 High Range 2 $25,000 $20,000 $17,000 $13,000 $5,000 $3,000 3 Mid Range 4 $15,000 $10,000 $10,000 $ 6.000 $1,500 $1,000 5 Low Range 6 $ 5,000 $ 2,000 $ 3,000 $ 1,300 $500 $200 Whether a penalty is to be assessed as a one—day assessment pr as a continuing violation on a per—day basis is addressed in the Circumstances section and on page 15. 000041’ ------- -17 • Adjusting the Gravity Based Penalty Follow the adjustment factor application instructions as presented in the general TSCA penalty policy document, “TSCA Civil Penalty System of September 10, 1980 at pages 9—16. Adjustment factors specific to this policy are discussed below. Other Factors As Justice May Require Voluntary Disclosure Penalty amounts for violations of TSCA 55 will be reduced when the violations are voluntarily disclosed by the company. For TSCA 55 violatIons the penalty reductions for voluntary disclosure are as follows. Voluntary disclosure . .. ......... ......... .25% Immediate disclosure within 30 days of discovery.. .. ...... ... ....... .25% Takes all steps reasonably expected . ....... ..... . .......... .u to 15% Total......up 0 or. vol e .The Civil p.&niflj_an .the. reason for he reduction. — The Agency wants to encourage voluntary disclosures for TSCA §5 vIolations. In order to do this, an automatic penalty reduction may be made. To be eligible, a firm must make the disclosure prior to being notified of a pending inspection and the disclosure cannot be one that Is required by TSCA 58(e) or that Is made after EPA has received information relating to the alleged violation. Voluntary disclosure of a violation will result In a 25% reduction of the penalty. In some cases, companies have delayed 9—12 months In re- porting a violation. An additional 25% penalty reduction may be given to those companies which report the potential violation to EPA within 30 days of having reason to believe that they may be In violation. This reduction is also applicable to firms which have changed ownership. If a company realizes it cannot find a chemical which It is manufacturing on the non—CBI Inventory, and for which ft did not submit a PMN, it has reason to believe that ft may be In violation. The time limit begins the moment the company has reason to believe that the chemical may not be on the Inventory, not after EPA has confirmed the Inventory status of the chemical. ------- —18— *Vfrimental1ybeieficiaT expendjtut’es above and beyoi d those ip Cif1celiy required under TSCA are allowabl4 T penalty reductions at the Agency’s discretion. Generally, environ- mentally beneficial expenditures may be deducted from the penalty at the Agency’s discretion fn accordance with the TSCA Clvii Penalty Policy for recall costs and special dis- posal costs. If such action Is requested by EPA or ündet’taken by the company independently, but not required by ISCA, a regulation, order, or TSCA 557 or 17 and such action is conducted in a manner satisfactory to EPA. As an alternative to the deduction of costs for environ- mentally beneficial expenditures, a penalty reduction of upto 15% may be eade foi v0 iuntari1ydisc1oséd 1o1at1ons at the Agency-’s dfscretlOn if the company takes aU steps reasóirably’ expectEdfrequestdby EPA to mitigate-the v1of.t1on -This- ‘ includes timely sUbrnf ssion of information necéssavy for EPA to assess a violation. Timely submission means within 30 days or a time period agreed upon by EPA and the company. This reduction is not in addition to reductions for environmental expenditures above and beyond that required by the law, but Is an alternative. Thfs reduction of ii to-15%tr *Vy p UI- cable to companies Wh1cb haveYoliantarlTy disclosed the violation and may b.tak n In addition to the Attitude f’the Violator adjustment found In the TSCA Civil Penalty Poltcy; If the steps expected/requested by EPA have not been taken at the time of sett1emen this section does not apply. Future activities maybi addressed in accordance with the Settlement with Conditions Policy. In some cases, mitigation may not be possible. For example, if the product was distr-ibuted-in commerce and has already been used, there may bE nothing the company can do to rectify the situation. In these cases, no reduction will be given under this heading. In other cases, if no steps are expected because cessation of the violative action Is sufficient, i.e., the chemical clears the PMN process and OTS makes a finding that no corrective actions are necessary, EPA may still give the added 15% reduction for companies that have voluntarily disclosed the violation, provided the penalty exceeds any economic benefit gained by the company. An example of a situation in which EPA may give the addi- tional 152 reduction is one in which a company manufactures a chemical not on the Inventory and does not file a PMN. The company notifies EPA of the possible violation, immediately ceases all manufacture, processing, and distribution until It files a PMN and the chemical clears the reviàw period without being a candidate for a TSCA 55(e) or 5(f) actIon. 000043 ------- —19— Economic Benefit In no cases shall reductions be given if the reduced penalty does not exceed the economic benefit gained from non- compliance. EPA should require the company to present infor- mation concerning economic benefit.s gained from the violative action prior to the reduction of the penalty except for the 25%/50% off far voluntary disclosure. In all cases, EPA wishes to encourage voluntary disclosure. Attitude The existing adjustment provision for the Attitude of the Violator in the TSCA Civil Penalty Policy (Septemeber 10, 1980) may also be applied to adjust the penalty by up to 15$. Please note that this d.justtv nt may decrease or increase the P! L b zJ5%. t hä-t oi I y aM-ôTrs--1n d--t A company would generally qualify for a downward adjustment If it Immediately halts the violative activity, takes steps to rectify the situation and there Is no finding of culpa- bility. However, such a reduction is at the discretion of EPA. History of Prior Violation The Agency will disregard the firm’s prior history of violations In calculating the penalty for a self—disclosed violation. However, for violations discovered by the Agency, the Agency will address history of prior violations as Indi- cated in the TSCA Civil Penalty Policy, even If the prior history results from a violation which was voluntarily disclosed. Culpability n9 wherL.a vJ tr daes, have c o impo tft c hem1cal subitance fro. a foreign manufacturer where the foreign manu- facturer falsely certifies that the substance is on the TSCA Inventory and the company importing the substance only knows the trade name of the substance. The importing company must be able to provide a copy of the written false certification and show that they were unable to ascertain the Identity of Agency can reduce the In the event of fii ther violations of this type, history of prior violation would not be considered when determining the penalty. ------- —20— Explanation of the Penalty Policy Nature The nature of a TSCA §5 violation depends on whether the violation deals with chemical control, control—associated data—gathering, or hazard assessment. 1. Chemical control regulations are aimed at minimizing the risk presented by a chemical substance by placing constraints on how the substance Is handled. Section 5(a)(2) authorizes the Administrator to make a determination that use of a hemica1 is a signifi- cant new use and require the manufacturer or importer to notify EPA prior to Initiating such a use. Sections 5(e) and 5(f) authorize a wide variety of chemical control requirements from labeling restric- tions to manufacturing bans. Section 5(h)(1) author- izes the Administrator to Impose restrictions upon the manufacture or processing of a test marketed substance. Violations of those restrictions that place constraints on how a substance Is handled fall into this category. Section 5(h)(3) obligates a firm producing a substance under a research and de- velopment exemption to give adequate warning to emp’oyees If that substance Is dangerous. This is also a constraint on a substance’s handling and is included in this category. 2. Control—assocIated data—gathering requirements are the recordkeeping and/or reporting requirements associated with a chemical control regulation. These requirements enable the Agency to evaluate the effectiveness of the regulation and to monitor compliance. Some requirements in ISCA §5(e) and 5(f) orders, rules, or injunctions would fall Into this category (i.e., a section 5(e) order that requires the manufacturer to keep records of all purchases of the regulated substance). Some test marketing exemption restrictions would also fall into this category as section 5(h)(1)(B) authorizes the Administrator to impose, among other things, recordkeeping and/or reporting requirements. 3. Hazard assessment requirements are used to develop and gather information necessary to weigh the risks and benefits presented by particular chemical sub- stances and to impose chemical control requirements when appropriate. This category includes violations for failure to notify, withholding information from EPA or submission of false or misleading information. 000045 ------- —21— Circumstances Circumstances are used in the penalty policy to determine the probability of potential harm. In other words, a variety of facts surrounding the violation as it occurred are examined to determine whether the circumstances of the violation are such that there is a high, medium, or low potential for harm. To calculate the penalty first use the nature determination list to select the appropriate nature category and then select the appropriate circumstance. Application of the Circumstances Factor to Section 5 1) Chemical control . Chemical control violations in- clude noncompliance with ISCA 55(s) or 5(f) actIons, failure to submit a significant new use notice, noncompliance with, a research and development exemp- tion restriction on adequate warning, noncompliance with test marketing exemption restrictions on the actual control of the substance, improper commercial use of a substance produced in violation of a ISCA §5(e) or 5(f) order, or noncompliance with any ex- emption restriction on the use of _a substance found under 40 CFR Part 723. For these violations, the initial circumstance level is based on the severity of the violation. Circumstance evaluations are adjusted by the degree of potential environmental exposure and potential risk posed by the chemical. 2) Control—associ ated data—gathering . Control—associ— ited data—gathering violations include noncompliance with the recordkeeping provisions of TSCA §5(e) or 5(f) actIons and exemption restrictions under 40 CFR Parts 720 and 723. For these violations the circum- stances are dependent on the extent to which the Agency’s ability to monitor and/or evaluate the risks posed by the substance or the company’s com- pliance with the substantive legal requirements is Impaired. 3) Hazard assessment . Hazard assessment violations Include failure to submit a premanufacturing noti- fication and associated commercial use, failure to submit a notice of commencement, withholding Infor- mation, submitting false or misleading Information, and noncompliance with the reporting provisions of ISCA §5(e) or 5(f) actions. ------- -22— When determining whether a PMN Is subject to a TSCA §5(e) or 5-(f) action, there are instances where rather than Imposing controls under a ISCA §5(e) order with testing triggered at a particular production volume or time, EPA requires testing upfront before manufacture may commence. If the company refused to either do he testing or withdraw the PMN, EPA would then unilaterally issue an “adversarial’ TSCA §5(e) order prohibiting any manufacture. This type of case would be treated as a TSCA §5(e) or 5(f) action and subject to higher penalties. When determining the circumstance level for recordkeeping violations when EPA has requested the missing records, EPA must be able to determine compliance from the records which are provided or the charge would be considered failure to produce the missing records Where records are necessary to determine compliance with a requirement of a TSCA §5 action, rule, or injunction and the records cannot be produced, EPA reserves the right to charge per day penalties. PMN violations involving chemical substances which meet all requirements for a polymer exemption under 40 CFR 723.250, except the company did not file for an exeuwptlon, will be assessed at a level 5 cIrcumstance. EPA has determined that chemicals which qualify for these exemptions are of less concern as a hazard. Extent Extent is used to take Into consideration the degree, range, or scope of the violation. The.ixte,tt. Matrix (pg. 13) provides for thre.e.J_evels of extent: M j9r :Stgn1-fi-cEnt- and- M i nor. i t it. aii” Irege of u t n II d thè v 1 o lit fve conduct . Production records will generally serve as the penalty ba.sls In the following violation categories: • Noncompliance with TSCA 55(e) or 5(f) orders, rules, or Injunctions and significant new use rules (except for reporting violations). • Noncompliance with test marketing or research and development exemption restrictions. Noncompliance with exemption restrictions under 40 CFR Parts 720 and 723. 000047 ------- —23— If a chemical substance is manufactured for commercial purposes as part of a chemical mixture, the amount of the chemical substance from which the mixture is made Is used to calculate the penalty. If a chemical mixture made from a chemical substance is Incorporated Into an article, the penalty Is calculated from the amount of the chemical sub- stance used to manufacture the chemical mixture. If the amount of chemical substance used to manufacture the chemical mixture is unknown, the amount of chemical mixture will be used to determine extent. If a portion of a batch containing an illegally manufactured chemical substance is sold/distri- buted for commercial purposes, the entire batch is considered to be manufactured for commercial purpo es and the amount of the chemical substance used to manufacture the entire batch Is used to calculate the penalty. Likewise, if one batch of an illegally manufactured chemical substance is sold/distributed for commercial purposes, all other batches of the chemical substance are considered to be manufactured for commercial purposes. If a firm disposes of a substance In violation of a test marketing restriction or a section 5(e) InjunctIon, then the amount ii legally disposed Is the basis of the penalty. Violations involving genetically altered, naturally oc- curring or genetically engineered microorganisms will all be placed In the major extent category due to the Agency’s general level of concern over the potential for harm from unregulated environmental release. In the event the Agency identifies low risk categories of organisms, violations in- volving low risk organisms will be placed In the significant extent level. It should be noted that if those records specified above are unavailable, the penalty should be assessed on those records that are available or where there are no records, assume the violation Is major In extent. Determining extent for violations involving withholding information, submitting false or misleading Information, or failure to generate reports as required by a ISCA 55(e) or 5(f) action requires different criteria. These violations are assessed for each day the violation occurred beginning from the day the information was submitted or should have been submitted. While the amount of a substance produced has an effect on the potential exposure of the public or environ- ment to that substance, the harm is caused by the failure to submit the data or submit true and complete data. Consistent with the TSCA 558, 12 and 13 Enforcement Response Policy, extent Is determined by the type of data involved in the violation. If the subject study involves laboratory animal data, the extent is determined to be significant. If the subject study involves physical/chemical properties or environmental fate data, the extent level is minor. ------- -24- The three levels of extent (major, significant and minor) are based on the potential for harm to health or the environ- ment. As stated previously, chemical control violations are considered the most serious due to the fact that risks have largely been identified and steps have been taken to mitigate those risks. Thus, the amount of production/disposal necessary to place a violation into the major and significant categories Is substantially less than the amounts which place a violation into those same categories for hazard assessment violations or control—associated data—gathering violations. Hazard assessment violations impair the Agency’s ability to determine the risks presented by a particular new chemical substance and impose control requirements. Because the Agency has no way of knowing whether the substance presents a risk to health or the envi- ronment, hazard assessment violations ire placed between chem- ical control violations and control—associated data—gathering violations in terms of the .amount of substance necessary to place a violation in the various extent levels. Control-asso- ciated data—gathering violations impair the Agency’s mission to mltgate threats to health and and the environment the least. These violations involve the recordkeeping provisions of a ISCA §5 action. Nonetheless, they are Important for the Agency to assure compliance. Application of the Extent Factor to Section 5 1) ChemIcal control violations . The Agency will have either knowledge or concerns that the substance may be harmful. Thus the potential for harm is greatest in this category. An amount of a substance that is considered minor or significant in the two other categories may be considered major here. A minor designation covers amounts from 0 to 250 lbs. (0 to 113.4 kg.); a significant designation covers amounts greater than 250 lbs. to 2,500 lbs. (113.4 kg. to 1,134 kg.); the major designation is assigned to amounts greater than 2,500 lbs. (1,134 kg.). 2) Control—assocIated data—gathering . Since production, distribution, etc. is always allowed, the penalties escalate more slowly than for the chemical control category violations: minor is 0 to 1,000 lbs. (0 to 453.6 kg.); significant is greater than 1,000 lbs. to 10,000 lbs. (453.6 kg. to 4,536 kg.); major is greater than 10,000 lbs. (4,536 kg.). 3) Hazard assessment . iii this category, the Agency can neither assume that the substance is harmless nor harmful. The violations, however, are more serious than those in the control—associated data—gathering category: minor is 0 to 750 lbs. (0 to 340.2 kg.); significant Is greater than 750 lbs. to 7,500 lbs. (340.2 kg. to 3,402 kg.); and major is greater than 7,500 lbs. (3,402 kg.). ------- —25— Gravity of the Violation Gravity refers to the overall seriousness of the violation. As used in this penalty system, gravity is a dependent variable (I.e., the evaluation of nature, extent, and circumstances will yield a dollar figure in the matrix that is the gravity based penalty). Imminent Hazard Imminent hazard violations require the Agency to make a finding that a particular violative substance presents an im- minent hazard to health or the environment. Penalties for violations Involving imminent hazards are assessed for each day the violation continues at the maxlmumpenalty allowable when a company manufactures and uses the hazardous chemical. In these cases separate charges, one for manufacturing and one for commercial use may •be assessed. Per—Day Penalties or One—Day Assessments TSCA 516(a)(1) provides not only that civil penalties may be assessed up to $25,000 but that each day a violation con- tinues is a separate violation for which penalties may be assessed. For the purposes of this ERP, per—day penalties will be assessed for each day a violation of ISCA 55 occurs. If, for example, a firm is charged with the illegal manufacture of a chemical substance, each separate day of manufacture constitutes a violation regardless of the number of batches produced during that day. The total amount produced In a day would be used as the basis for the extent of the violation if a company has more than one facility illegally producing a substance on a given day. Likewise, if a firm illegally disposed of a substance, the penalty is based on the number of days the disposal occurred regardless of the number of shipments for disposal on a given day. The total amount of a substance produced or disposed of on a given day Is used when determining extent. Where the manufacture or processing of a substance takes several days to complete, the penalty Is based only on the day the manufac- turing or processing was completed. For example, If it takes 3 days to manufacture a substance In violation of TSCA 55, the penalty would be assessed for the day the manufacture of the substance was completed (day 3). ------- —26— Violations which warrant daily penalties are those which Impair the Agency’s ability to assess the risks to public health or the environment. These penalties are assessed from the date of occurrence to the date of discovery. Per—day penalties will be assessed for the following viola- tions: - • Withholding information or submitting false or mislead- ing Information • Failure to generate reports as required by a TSCA §5(e) or 5(f) action • Noncompliance with TSCA §5(e) and •5(f) orders, rules, and injunctions (chemical control aspects) • Noncompliance with, research and development exemption restrictions (violation of adequate warning and ex- pert supervi sion requirements) • Commercial use of an illegally produced substance • Noncompliance with exemption restr9ctlons under 40 CFR Parts 720 and 723 (chemIcal control aspects) • Failure to notify Peni1 t4e 5’ fo’r •d16épngvi ol atl 0 ns wtU be as ses ’sed on 7 ‘a .on e -t I ITfe.. ally ‘pose asLg eattc a ri-sk ’to public health, or the- enY1 ronm’ë nt. Th”e .v4o-la-t;io . ns: a’ri se fro,w a:s1ngle violative act . One—day penalties will be assessed for the following violations: • Noncompliance with section 5(e) and 5(f) orders, rules, and injunctions recordkeeplng provisions only. The Agency reserves the right to assess per day pen- alties for recordkeeplng violations when compliance wltb a requirement of a TSCA §5 actIon, rule or Injunction cannot be verified. • Noncompliance with exemption restrictions under 40 CFR Parts 720 and 723 involving recordkeeping provi slons. • Not. lce o ECommencement-.v1olations.. The Agency re- serves the right to charge a pir day violation in those cases where the notice was intentionally withheld by the company. 00005! ------- -27— Multiple VlolationslCheinlcaIs Multiple violations of a ISCA §5 action, rule, or injunc- tion will be assessed separately for each distinct violation. Where more than one chemical substance Is in violation, penal- ties will be assessed for each violative chemical. Adjustment Factors Voluntary Disclosure This Is an activity which the Office of Compliance Mont— toring (0CM) wants to encourage. If EPA receives a voluntary disclosure, the Agency can proceed with action to rectify a situation even if the manufacturer is reluctant. Actions by EPA to convince a violator to do the right thing may Include penalties Issued on a per—day basis, ISCA Ui or 17 actIons, or other additional rule—making. Although 0CM considered Including the condition that the manufacturer acted in good faith prior to the violation and that t he ceased the violative act as soon as he had reason to know of the violation, 0CM decided not to Include this as a condition for the 25$ reduction for the following reasons: 1) If the violation continues, EPA may assess penalties against the manufacturer for each day of violation. 2) In calculating the penalties for yb— lations after the violator knew of the violation, a culpability factor for those days may be added. 3) If the violator intended to violate TSCA prior to disclosing the violation, the penalties for the entire period of violation may be increased based on a culpability findIng. 4) If the violator does not act to rectify the situation, his penalties may be Increased based on attitude if no finding of culpability Is made. 5) IrrespectIve of the circumstances of the violation, the Agency wants the manufacturer to report it. Immediate Voluntary Disclosure 0CM wants to further encourage prompt reporting. There- fore, an added incentive is provided so that the Agency is notified soon after the manufacturer has reason to know of a potential violation. History of Noncompliance As a further incentive for the voluntary disclosure of violations, the Agency has decided to forego the Imposition of penalty Increases for a history of noncompliance in assessing penalties for voluntarily disclosed violations. However, a voluntarily disclosed violation does constitute a violation and is to be used to increase penalties for future violations which the Agency discovers. ------- Definitions Consumer — Any person who uses a chemical substance for any purpose. Off—site Restrictions— Off—site restrictions are those re- strictions placed on a substance after It leaves the original site of manufacture or processing. On—site Restrictions — On—site restrictions are those restric- tions imposed upon a Company by EPA through a TSCA $5 action, rule, or Injunction at the site of manufacture or processing. IP kiepni dZe efrVtv - r;equi r e’s tfrC ñi á táWñ tf9fs fsé s a t O uWne St. Reports — Reports are those data the Agency Is requiring the Company to submit to EPA under TSCA §5. 000053 ------- APPENDIX 1 EXAMPLES Failure to Notify Exa’ne 1 - A company has produced a chemical substance, which is not on ttue Inventory for 5 years, with production occurring on 50 days each year, and 1,000 pounds of the substance produced on each day of production. The chemical substance Is consumed in another chemical reaction. The company stops production Immediately up ; discovery of the violatlon•, voluntarily discloses the violation within 30 days, submits a PMN within 30 days and takes all the steps EPA requests of them. The PMN goes through review without any health or environmental concerns being raised. The company Is charged with a failure to submit a PMN, level 4, significant, per-day. $6,000 X 5 X 50 ‘ $1,500,000 80$ reduction in penalty warranted — $1,200,000 Final Pen ’ty — $300,000 Example 2 A company has produced a chemical substance, which is not on the Inventory, for 4 years with production occurring 50 days per year, and 8,000 pounds of the substance produced on each day of production. The chemical substance is further processed by the company on 100 days per year, 4,000 pounds processed on each day and sold In an end—use product. The company discovers the violation, immediately stops production, volun- tarily discloses the violation within 30 days, submits a PMM within 30 days and takes all steps EPA asks of them. The PMN review identifies a substantial environmental concern and the company subsequently enters into a TSCA 55(e) consent order to address this concern. The company Is charged with a failure to submit a PMN, level 1, major, per—day. 4 X 50 X $25,000 • $5,000,000 80% reduction In penalty warranted — $4,000,000 Final Penalty — $1,000,000 ------- Example 3 pany has produced a chemical substance, which is not on nventory, for 8 years, with production taking place 25 , a year, and- 3,000 pounds of the substance produced on ch day of production. The chemical substance is incorpor- ated into a product which is sold to its customers for use in a consumer p’-’rtuct. The company discovers the violation and reports it -. EPA 75 days later, after it has developed a legal substitute for the illegal chemical substance and has been notified of a pending inspection. A PIN is not filed as the company has no intention of making the illegally pro- duced substance again. The company produces production records for the substance only after missing two deadlines for submitting the records. The company is charged with a failure to submit a PMN, level 3, signifIcant, per—day. $10,000 X 8 X 25 = $2,000,000 15% penalty adjustment upward for-attitude - $300,000 Final Penalty — $2,300,000 Example 4 A company failed to submit a Notice of Commencement to EPA. The first day of production yielded 3,000 pounds of the bstance. EPA discovered the violation. The company is arged with a failure to submit a Notice of Commencement, Jevel 3, -‘g”ifitai , one—day. The sif,ooo. Example 5 A company produced a chemical substance regulated by a SNUR, for a significant new use as defined by the SNUR, without submitting a Significant New Use Notice to EPA. The sub- stance was incorporated into a consumer use product. The company produced the chemical 9 times, with 3,000 pounds produced on each occasion. EPA discovered the violation. The company Is charged with a failure to submit a Significant New Use Notice, level 1, major, per—day. 9 x $25,000 = $225,000 000055 ------- —2— Example 3 A company has produced a chemical substance, which is not on the Inventory, for 8 years, with production taking place 25 days a year, and 3,000 pounds of the substance produced on each day of production. The chemical substance Is Incorpor- ated into a product which is sold to Its customers for use In a consumer product. The company discovers the violation and reports it to EPA 75 days later, after It has developed a legal substitute for the illegal chemical substance and has been notified of a pending Inspection. A PMN Is not filed as the company has no intention of making the Illegally pro- duced substance again. The company produces production records for the substance only after missing two deadlines for submitting the records. The company is charged with a failure to submit a PMN, level 3, sIgnificant, per—day. $10,000 X 8 X 25 $2,000,000 15% penalty adjustment upward for attitude — $300,000 Final Penalty — $2,300,000 Example 4 A company failed to submit a Notice of Commencement to EPA. The first day of production yielded 3,000 pounds of the substance. EPA discovered the violation. The company Is charged with a failure to submit a Notice of Commencement, level 3, significant, one—day. The company would be charged $10,000. Example 5 A company produced a chemical substance regulated by a SNUR, for a significant new use as defined by the SNUR, without submitting a Significant New Use Notice to EPA. The sub- stance was Incorporated into a consumer use product. The company prodiced the chemical 9 times, with 3,000 pounds produced o i each occasion. EPA discovered the violation. The company (s charged with a failure to submit a Significant New Use Notice, level 1, major, per—day. 9 x $25,000 $225,000 ------- —3— Example 6 An cnspector discovers a study that should have been submitted In conjunction with a PMN application. The study Involved ani- mal testing data. The chemical substance was produced for 1 year before the violation was detected. The company is charged with witholding Information, level I, significant, per—day. $17,000 X 365 $6,205,000 Example 7 A company produces a chemical substance’under a TSCA S5(e) order. The order requires the company to train workers and requires the employees to wear respirators while engaged in the manufacture of the substance. The inspector discovers that the company has not conducted training as required and that the workers do not wear respirators, or have them available, while engaged in the manufacture of the substance. Production has taken place on 30 days with 5,000 pounds of the substance pro- duced each day. The company Is charged with two counts, fail- ure to provide training and failure to require their employees to wear respirators, level 2, major, per—diy. $20,000 X 2 X 30 • $1,200,000 Example 8 A company produces a chemical substance under a TSCA S5(e) order. The order requires the company to Incinerate all wastes derived from the production of the chemical substance. An Inspector discovers that the company has. not Incinerated the wastes as required, but has been releasing the wastes to water after primary treatment. Disposal took place on 50 days with 2,000 pounds disposed of each day. The company Is charged with failure to follow the restrictions of the TSCA §5(e) order regarding disposal, level 1, significant, per— day. $20,000 X 50 • $1,000,000 030057 ------- —4— Example 9 A company produces a chemical substance under a TSCA §5(e) order. The order requires the company to either stop pro- duction or submit a study to EPA after producing 400,000 pounds of the substance. The company submits the study to the Agency and the_ study is approved. A subsequent Inspection re- veals that the company had produced 450,000 pounds of the sub- stance prior to submitting the study, producing 5,000 pounds of the substance on 10 different days. The company Is charged with violation of a production ban, major, level 1, per—day. $25,000 X 10 $250,000 Example 10 A company has manufactured and processed a chemical substance, which Is not on the Inventory, for 8 years with manufacturing occurring 100 days each year, 5,000 pounds manufactured each day and processing occurring 200 days each year, with 2.500 pounds processed each day. The processed chemical substance is Incorporated into an end use product. An Inspector dis- covers the violation. A review of the chemical by EPA Iden- tifies a substantial environmental concern which would have placed the the substance as TSCA §5(e) order candidate. The company is charged with a failure to submit a PMN, level 1,, significant, per—day. $20,000 X 8 X 100 $16,000,000 Example 11 A company applied for and recleved a low volume exemption for a chemical substance. An inspector discovers that the company produced 1500 kg of the substance In 3 different years with production occurring on 3 days each year, 500 kg produced each day. The chemical substance would have had a TSCA §5(e) order Issued If it had not been granted a low volume exemption. The chemical substance was distributed to customers. The com- pany would be charged with a failure to file a PMN, level 1, significant, per—day. $20,000 X 3 X 3 — $180,000 ------- —5— Example 1? A company produced a chemical substance which is not “n the Inventory, for 5 years, with production occurring on 50 days, 5,000 pounds produced each day. The chemical substance was further processed for. 100 days each year with 2,500 pounds of the substance processed each day. The finished product con- taining the chemical substance was distributed to consumers. The chemical substance was a polymer that otherwise would have qualified for a polymer exemption. The company is charged with failure to file a PMN, level 5, sIgnificant, per—day. $3,000 X 5 X 50 $750,000 Example 13 Company A solicited several manufacturers to produce a chemical substance for them. They were advised by one company that the substance did not appear on the Inventory and that a PMN would have to be filed prior to manufacturing. Another company agreed to produce the chemical for Company A. Company A commercially used the chemical substance for 5 years, 100 days per year, processing 3,000 pounds of the substance on each occasion. EPA discovered the violation at the manufacturing company and charged the manufacturing company with a failure to file a PMN. The PMN was filed and no problems were found with the chemical substance auring the PMM review. A subsequent Inspection of Company A discovered the letter from the manufacturer who had advised Company A of the status of the chemical. Company A was charged with commercial use of an illegally manufactured sub- stance, level 3, maJor, per—day. 5 X 100 X $15,000 — $7,500,000 000059 ------- Failure to Notify VIOLATION Failure to submit a PMN order or exemption when to consumers or further company. not subject to a TSCA 55(e) or 5(f) the substance was not distributed processed for commercial use by the Failure to submit a PMN not subject to a TSCA 55(e) or 5(f) order or exemption when the substance was distributed to consumers or further processed for commercial use by the com- pany. Failure to submit a PMN when the substance is or would have been the subject of a TSCA §5(e) or 5(f) action but was either distributed to consumers or further processed for commercial use by the company. Failure to submit a PNN when the been the subject of a TSCA §5(e) substance was either distributed processed by the company. substance is or would have or 5(f) action and the to consumers or further Failure to submit a PMN for a chemical substance which would meet all requirements for a polymer exemption under 40 CFR 723.250, except that the company did not file for an exemption. Failure to submit a PMN for a chemical substance which would meet all requirements for a polymer exemption under 40 CFR 723.250, except that the company did not file for an exemption and the substance was further processed for commercial use, distri- buted to consumers, or released uncontrolled into the envi- ronment. Illure to submit a Notice of Commencement. LEVEL 4 3 2 1 5 4 3 PER—DAY/ NATURE ONE-DAY Per—day Per—day Per—day Per—day Per—day Per—day One-day HA HA HA HA HA HA HA HA — Hakard Assessment CC - Chemical Control CADG - Control-Associated Data—Gathering ------- Amended 2 vloLnrIu;1 lure to submit timely tiotice of Commencement (early or ate submission, up to 30 days prior to manufacture or 30 to oU days after manufacture). Failure to subunit a timely Notice of Commencement (early or late submission, more than 30 days prior to manufacture or more than 6(1 days after manufacture). WithholJing information or submitting false or misleading Information with rejard to a PMI1, Significant New Use Notice, or ex rnption request. Submission of a f3ls Hotice of commencement. Noncompliance with TSCA §5(e) or 5(f) Orders, Rules or Injunctions and Significant New Use Rules Violation of on—site restrictions. Violation of off-site restrictions where the substance was either processed by another firm or distributed to consumers or released uncontrolled into the environment. Failure to submit a Significant New Use Notice when the sub- stance was not distributed. Failure to submit 3 Significant New Use Notice when the sub- stance was distributed to consumers. Violation of production ban or restriction. LEVEL .6 4 1 1 2 1 2 1 1 PE R—L)AY/ ONE-)AY One—day One-day Per—day One—day Per-day Per—day P /day Per-day Per-day Per—dew HA HA HA HA cc cc cc cc cc — C) C) C) C) Failure to generate reports as required. 2 HA ------- VIOLATION LEVEL PER—DAY/ NATURE ONE-DAY Failure to generate reports as required, where tI ILthstance was either processed by another firm or distributed to 1 Per-day HA Consumers or released uncontrolled inE1 the environment. Late submission of required reports where the substance was not distributed or processed. 4 Per-day HA Late submi ssion of required reports where the substance was either processed by another finn or distributed to consumers 3 Per—day HA released uncontrolled Into theTnvlronment. Withholding Information or submitting false or mIsleading 1 Per—day - HA i nfonna tion. Violation of the recordkeeping provi sions where the finn produces the missing records within 5 days of an EPA request. 4 One—day CADG Violation of the recordkeeping provisions where the firm cannot produce the ml ssing records wi thin 5 days of an EPA 3 One-day CAI)G request except as specified on page 26 of the policy. Coamiercial Use of an Illegally Produced Substance Commercial use violations will be charged In three circumstances: 1. When a company processes or uses a chemical substance which It did not manufacture and it has reason to know Is not on the Inventory. 2. When a chemical substance was manufactured or Imported ille— gaily on just a few occasions and processed over a long per- iod of time, th substance would have been subject to a TSCA S5(e) or 5(1) order, and the activity could have caused substantial endangerment to health or the environment. ------- VIOLATION LEVEL PER—DAY/ NATURE ONE-DAY Commercial use violations will be assessed as fbi-lOws: Violation where the substance was not processed by or dls— 4 Per—day CC tributed to others after recef rbTthe user. Violation where the substance was further processed by or 3 Per—day CC distributed to others. Violation where the substance Is or would have been the subject of a TSCA §5(e) or 5(f) actIon but was not processed by or 2 Per—day CC distributed to others. Violation where the substance Is or would have been the subject of a TSCA §5(e) or 5(f) action ançl was either processed by 1 Per—day CC others or released uncontrolled Into the environment. Noncompliance with Test Marketing Exemption Restrictions Overproduction by 102 or less. 3 Per—day CC Overproduction of more than 10% would be charged as a failure to submit a PuN. Violation of exposure related, on-site restrIctions. 2 Per—day CC Violation of recordkeeping provisions except as specified on 4 One—day CADG page 26 of the policy. Violations of the off-site control provisions of a ThE where the substance was either distributed to consumers or was 1 Per—day CC released uncontrolled into the environment. Noncompliance with Research and Development Exemption Restrictions Violations regarding the labeling of the R&D substance where the substance was further processed by another fIrm. 2 Per-day CC ------- VIOLATION LEVEL PER—DAY/ NATURE ONE-DAY Violations regarding the labeling of the R&D sub taftce where the substance was either di stributed to consumers or was I Per—day CC released uncontrolled Into the environment. Please note that any violation of an R&D exemption other than failure to adequately label the R&D substance, would cause the charge to be a failure to submit a P1 11 1. Noncompliance with Low Volume Exemption Restrictions Violations regarding the notification of customers of the re- strictions on use of the substance. 2 Per-day CC Violations regarding the failure to notify EPA of any changes In site or use of the exempted, chemIcal. 2 Per—day CC Violations of the recordkeeping provisions of the low volume 3 One—day CADG exemption except as specified on page 26 of the policy. Violations of the 1,000 kg. production limit would be viewed as a failure to submit a PMN. Violations regarding the failure to maintain required exposure 2 Per—day CC controls. Noncompliance with the Instant Photographic and Peel-Apart Film Article Exemption Restrictions Failure to limit manufacturing and processing to site(s) listed In the exemption application. 5 Per—day CC Distribution in commerce or use of a peel-apart film article containing a new chemical substance prior to Its being cleared ttrough the PMN process would be considered a failure to submit a P1111 and subject to the penalties thereunder. ------- 6 VIOLATION LEVEL PER—DAY/ NATURE ONE-DAY Failure to follow the conditions of manufacturefor Instant photographic or peel—apart film articles where the substance 2 Per-day CC would not have been subject to a TSCA §5(e) or 5(f) order. Failure to follow the conditions of manufacture for instant photographic or peel—apart film articles where the substance 1 Per—day CC would have been subject to a TSCA §5(e) or 5(f) order. Violation of the recordkeeping provisions of this exemption 3 One—day CADG except as specified on page 26 of the policy. Noncompliance with Polymer Exemption Restrictions Violations regarding the submission of test data with the 1 Per-day HA exemption application. Violations of the recordkeeping provisions of the polymer exemption except as specified on page 26 of the polIcy. 4 One—day CADG All other violations of the polymer exemption would be charged as a failure to submit a P111 1. 2z,oducti on Production of a chemical substance after submission of a PMN but prior to the expiration of the PMN review period. 3 Per-day HA ------- VIOLATION LEVEL PER— DAY/ NATURE ONE—DAY Production of a chemical substance after submtssion of a PMN but prior to the expiration of the PMN review period when the substance becomes or would have been the subject of a 2 Per-day HA TSCA §5(e) or 5(f) action or the substance was distributed to cons wne rs. Production of a chemical substance prior to the expiration of the PMN review period when the substance becomes or would have 1 Per—day HA been the subjec’ of a TSCA 55(e) or 5(f) actIon and the substance was distributed to consumers. Other Violations Any other violation not listed above. 4 Per—day HA EXTENT MATRIX Nature A Major Extent Level C Minor B Significant ChemIcal Control ‘2,500 lbs >1,134 kg ‘250 lbs to 2.500 lbs >113.4 kg to 1,134 kg >0 >0 to 250 lbs to 113.4 kg Control— Associated Data- Gathering >10,000 lbs >4,536 kg >1,000 lbs to 10.000 lbs >453.6 kg to 4,536 kg ‘0 >0 to 1,000 lbs to 453.6 kg Hazard >7,500 lbs >750 lbs to 7,500 lbs >0 to 750 lbs Assessment >3.402 kg >340.2 kg to 3,402 kg >0 to 340.2 kg ------- ADDRESSEES Mike Shapiro CTS—788) Charles. Elkins (TS—792) Frederick P. Stiehi (LE—134) Mark Greenwood (LE-].32A) A.E. Conroy XI (EN—342) Diane Bea] John J. NeyXan XIX Mike Wood - David Dull Jerry Stubbs Phyllis Plaherty Bob Zisa Sherry Sterling Maureen Lydon Ken Kanagalingam Jan Bearden Jake Mackenzie Western Regional Compliance Director Dean Hill, NEIC I Louis F. Gitto, Director Marvin Rosenstein, Chief Air Management Pesticide & Toxic Subs. rI II Barbara Metzger, Director Ernest Regna, Chief Environmental Services Div. Pesticides & Toxic Subs. Br III Thomas C. Voltaggio Larry Miller, Chief Acting Director Toxic & Pesticides Branch Hazardous Waste Management Division IV Winston A. Smith, Director Richard DuBose, Chief Air, Pest. & Toxic Mangt. Pesticides & Toxic Subs. Br Division V William H. Sanders III, Dir Phyllis Reed, Chief Environmental Services Div Pesticides & Toxic Subs. Br VI William B. Hathaway, Dir Robert Murphy, Chief Air, Pesticides & Toxic Subs. Pesticides & Toxic Subs. Br Division VII William A. Sprat]in, Dir Carl Walters, Acting Chief Air and Toxics Division Pesticides & Toxic Subs. Br VIII Irwin 1.. Dickatein, Director Alvin Yorke, Chief Air and Toxics Division Toxic Substances Br 000069 ------- —2— IX David P. Howekamp, Director Davis Bernstein, Chief Air Management DiviSiOn Pesticides Toxic Subs. Br X Gary O’Neal, Director Kenneth Feigner, Chief Air and Toxics Division Pesticides & Toxic Subs. Br cc: Michael Walker (LE—134P) Jim Willis (TS—788) Alicia Tenuta (A—107) ------- , iIO SP 4 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 MAY 15 1981 OPPICC o P STICIDU AND TOXIC $USSTANCLS MEMORANDUM SUBJECT: Final Enforcement Response Policy fo and 13 FROM: John J. Neylan II I, Director Policy and Grants Division Office of Compliance Monitorl TO: Addressees Attached is the final revised Enforcement Response Polcy (ERP) for TSCA § 8, 12 and 13. The final ERP remains very similar to the proposed ERP issued on March 27, 1987 with changes made in three areas. Failure to maintain TSCA §8(c) records in a manner that meets the standard required in the rule has been made a sig- nificant, level 3, one—day violation ($10,000). The second change made is the addition of a violation for failure under the ISCA §8(a) Inventory Update Rule to keep records showing that the manu- facturer Is not subject to reporting. under the rule (major, level 6, $2,000). The third change to the ERP is a modification in the per day assessment for violations of TSCA §8(a) Chemical Specific rules. The per day assessment is now the the base penalty divided by 360. The maximum penalty for failure to report is now $34,189, while the maximum penalty for late reporting Is $12,067. This ERP supercedes the previous ISCA § 8, 12 and 13 ERP and Its two succeeding amendments. I would once again like to thank the Regions for their comments and cooperation In formu- lating this ERP, especially the Regional participants in the workgroup. If you have any questions concerning this final ERP, please contact David Stangel of my staff at (FTS) 382—7825. A discussion of the comments is attached. Attachments 000071 ------- Addressees Charles Elklns Frederick F. StIehi Stanley Abramson Ken Shirolshi Phyllis Flaherty John Martin John J. Neylan-Ill Ralph Turpin Mike Wood Gerald Stubbs Dexter Goldman Michael Walker Margaret Rostker Michael Stahl Jake Mackenzie Western Regional Compliance (11 rector A. Charles Lincoln Eastern Regional Compliance Director Louis F. Gitto, Director Air Management Division, Region I Barbara Metzger, Director Environmental Services Division, Region II Stephen R. Wassersug, Director Hazardous Waste Management Division, Region III Winston A. Smith, Director Air, Pesticides and Toxics Management Division, Region IV William H. Sanders III, Director Environmental Services Division, Region V William B. Hathaway, Director Air, Pesticides, and Toxics Division, Region VI William A. Spratlin, Director Air and Toxics Division, Region VII Irwin L. Dlckstein, Director Air and Toxics Division, Region VIII Jeffrey Zelikson, Acting Director Toxics and Waste Management Division, Region IX Gary O’Neal, Director Air and Toxics Division, Region X (TS—792) (LE-134A (LE-132A (EN—342) II U I, U U I, (LE—134P) (TS—788) (TS—788) (Asbestos documents) Regional Pesticides and Toxic Substances Branch Chiefs ------- RESPONSE TO COMMENTS Comment: The penalties for TSCA §8(a) Chemical Specific reporting are too high and should be assessed as a one—day penalty in the same way that Inventory violations are handled. Re s ponse: The Office of Compliance Monitoring and the Office of Toxic Substances feel very strongly that penalties for TSCA §8(a) CAIR and PAIR violations be higher than those for TSCA §8 Inventory violations. In most cases, the Agency is asking for the informa- tion under very strict statutory or court Imposed deadlines and the information is used to .determlne how the Agency will regulate a chemical substance. The failure to report data in a timely man- ner could seripusly impairthe decision to regulate a chemical substance. We are, however, sensitive to the Region’s concerns regarding the amount of the penalties. The ERP, therefore, has been amended to reduce the amount of the per day penalty by di- viding the base penalty by 360 instead of 180. ThIs would re— suit in a maximum penalty for failure to report violations of I $34,189, with $12,067 being the maximum assessed for late report- ing. Both OTS and 0CM feel that while the penalties are higher than those in the previous ERP, they are appropriate and shall remain per day violations. Comment: The TSCA §8(a) Inventory Update penalties are too high con- sidering that many of the violators will probably have multiple violations, due to ignorance of the regulations. Response: While we agree that there may be instances where a manufac- turer is ignorant of the regulations, these instances should not dictate the penalty structure. The Inventory Update Rule Is con- structed In such a way that most small manufacturers (the group most likely to be ignorant of the rule) are exempt from reporting. In the event that a manufacturer fails to report on a large num- ber of substances, the size of the business may mitigate the pen- alty or the company could undertake other activities to mitigate the penalty. If a large manufacturer fails to report on a large number of substances, a substantial harm may have occurred to the Agency’s efforts to characterize exposure and the penalties would be appropriate. 000073 ------- -2- Comment: The penalty policy is inconsistent in that a failure to re- cord ISCA §8(c) allegations at all is categorized as a significant level 1 violation ($17,000) while a company that does keep aflega- tions but fails to keep them in the manner prescribed Is assessed a major, level 2 violatIon ($20,000). Response: We agree that this situation is Inequitable. The ERP has been amended so that a failure to maintain TSCA §8(c) records In a manner that meets the standard required In the rule woula be a significant, level 3, one—day violation ($10,000). There may be Instances of a failure to maintain records or reports In a manner that meets the standard required In other rules so the violation will be reflected- as both a level 2 and a level 3 vio- lation. The ERP distinguishes between TSCA §8(c) records and other records. Comment: The ERP should incorporate some method of employing gross market share/volume categories when determining penalties. Response: The workgroup has discussed a number of methods of factoring market share or volume into the penalty calculations and has not been able to develop a workable system to Incorporate these para- meters into hazard assessment. Basically, the workgroup does not believe that harm can be related to market share. Other problems with such an approach are accurately determining market share, dealing with those chemicals where the Agency is concerned with very small amounts of a substance, and the potential for divulging confidential business Information. Comment: The current system of referring TSCA §13 cases to the Region where the importer Is located rather than allowing the Region where the entry, and subsequent violation, occurred to take the case is Inequitable. Response: 0CM agrees that Regions where the majority of importation occurs bear a much greater resource burden without receiving pro- per recognition for the resources expended. We are reluctant to once again amend the SPMS reporting system to include Information on referrals to other Regions. We propose to Include this infor- mation on the PC Tracking System and have these referrals be re- flected In workload modeling. ------- —3— Comment: Regions should charge brokers with violations of TSCA §13 as a means of acheiving compliance with the import regulations. Response: This office is deeply concerned with the practice of bringing actions against a broker as a means of reducing the number of ISCA §13 violatIons. The regulations at 40 CFR 707.20 require the Im- porter to certify compliance with TSCA for all chemical substances imported. The Importer is clearly the responsible party regard- less of the type of contractual arrangement the importer may have with the broker. It is the responsibility of the importer to do business with responsible brokers. While we agree that brokers are responsible for many of the violations that occur and a tech- nical assistance program would be of great benefit to educate the brokers, the importers areultimately responsible for compliance with TSCA notwithstanding the actions of their agents. An importer may wish to recover damages from a broker after the Agency has concluded its civil action, but that Is a matter for which the Agency has no concern. National policy requires that civil ac— 1 tions be directed to the Importer of record. Questions have been raised as to the legality of directing any type of enforcement actions towards the broker which 0CM and OECM are attempting to address. Regions may wish to consider an educational campaign for those brokers who commit violations of TSCA §13, along with an informal warning letter to the broker stating the violation. Comment: Headquarters should reconsider the policy of concurrence for all cases settled under the new ERP, especially those taken under TSCA §13. Response: This ERP was revised In part to answer the concerns of the Regions that the penalties under the old ERP were unrealistically high and based mainly on when EPA conducted an Inspection rather than the potential harm that could have occurred. We feel that these concerns have largely been answered by this document. While the penalties assessed under this ERP will generally be less than those In the past, we are concerned that penalties may be reduced as they were In the past. We feel that the differ- ences between the penalty assessed and the penalty collected should be much smaller under this ERP than in the past. We are more concerned with penalties under TSCA §8, but feel It would be beneficial to monitor the penalties assessed for all ,.‘ 7 lj,J J )I ) ------- -4- violations under this ERPI We anticipate re axat1on of con- currence for TSCA §13 violatIons to be forthcoming after re- viewing the actions taken under this ERP. However, given the wide disparity in how the Regions administer actions under TSCA § 8, 12 and 13 at this time, we feel that requiring con- currence as a means of administering the new ERP Is prudent. Comment: 0CM should distribute drafts of ERPs to the Office’s of Re- gional Counsel as well as the Regional program offices. Response: At the insistence of the Office of Enforcement and Compliance Monitoring (OECM), drafts of ERP’s are directed to that office with OECM being responsible for transmitting these documents to the ORC. ------- MAY 15 1981 RECORDKEE [ NG AND REPORTING RULES TSCA SECTIONS 8, 12 AND 13 ENFORCEMENT RESPONSE POLICY OFFICE OF COMPLIANCE MONITORING OFFICE OF PESTICIDES AND TOXIC SUBSTANCES THE U.S. ENVIRONMENTAL PROTECTION AGENCY oooo;’7 ------- INTRODUCTION Section 8 of the Toxic Substances Control Act (TSCA) author- izes EPA to require chemical manufacturers, importers and pro- cessors to keep records and to report certain information. TSCA §12 requires the submission to EPA of Information about chemical exports. The TSCA §13 rule requires the submission of certifica- tion statements concerning import shipments of chemical substances. These reporting and recordkeeplng provisions have similar types of requirements, and therefore, similar types of violations. For this reason, this Enforcement Response Policy addresses all these provisions as TSCA reporting and recordkeeping requirements. Failure to comply with the recordkeeplng and or reporting provisions of TSCA Is a violation of TSCA § 15(3)(A) and 15(3)(B) and subject to the remedies In TSCA §16. Summary of Requirements/Rules Covered TSCA §8(a) Inventory - Required reporting during 1977 by person who manufactured and/or Imported reportable chemicals. (At this date, these violations are most likely failures to report or falsified reports.) (40 CFR 710) TSCA §8(a) Inventory Update - Requires reporting by persons who manufacture or import chemical substances which are on the TSCA Chemical Inventory in quantities greater than 10,000 lbs. at a specific site. Small businesses and certain classes of chemicals are excluded. (51 FR 21438, June 12, 1986, 40 CFR 710) TSCA §8(a) Preliminary Assessment Information Reporting Rule ( PAIR) - kequires reporting by persons who manufacture or im- port listed chemicals in quantities greater •than 1,100 lbs. per site. Small businesses are excluded. (47 FR 26992, June 22, 1982, 40 CFR 712) TSCA §8(a) Asbestos Reporting — Required reporting by persons who mined, manufactured, imported , or processed asbestos by November 1, 1982. ExemptIons included small businesses, dis- tributors, and builders. (47 FR 33198, July 30, 1982, 40 CFR 763) TSCA §8(a) Chemical Specific Rules TSCA §8(a) P-TBBA, P-TBT, P-TBB - 40 CFR 704.33 TSCA §8(a) Chlorinated naphthalenes — 40 CFR 704.83 TSCA §8(a) Chlorinated terphenyl — 40 CFR 104.85 TSCA §8(a) Hexachioronorbornadiene — 40 CFR 704.142 TSCA §8(a) 4,4’—methylenebis(2—chloroanhline)(MBOCA) — 40 CFR 704.175 030079 ------- -2— ISCA §8(a) Polybrominated biphenyls (PBBs) — 40 CFR 704.195* TSCA §8(a) Tris (2,3—dibromopropyl) phosphate — 40 CFR 704.20 * These rules have been “sunsetted” and replaced by SNUR’s. TSCA §8(c) Alleged Significant Adverse Reactions - Requires persons who manufacture, import, process, or distribute chem- ical substances or mixtures in commerce to keep files of alle- gations of significant adverse reactions and provide this in- formation to EPA upon request. Exemptions include persons whose activities consist of mining or other solely extractive functions; processors who are not also manufacturers if none of the processors’ sites are engaged In activities described in SIC 28 or SIC 2911; and persons who are solely distributors or retailers. (48 FR 3817a, August 22, 1983, 40 CFR 717; amended 50 FR 46766, November 13, 1985, 40 CFR 717) ISCA §8(d) Health and Safety Studies SubmissIon.. — Requires persons who manufacture, import, process, or propose to manu- facture, Import, or process listed chemicals to submit lists or copies of unpublished studies to EPA. (47 FR 38780, September 2, 1982, 40 CFR 716 amended September 15, 1986, 51 FR 32720) TSCA §8(e) SubstantIal Risk Reporting — Requires persons who manufacture, import, process, or distribute in commerce a chem- ical substance or mixture and who obtain anew” information which reasonably supports the conclusion that such substance or mix- ture presents a substantial risk of injury to health or the en- vironment to report such Information to EPA within 15 days. (Policy Statement, 43 FR 11110, March 16, 1978) ISCA §12 Exports — Requl res persons who export chemicals subject to final and certain proposed rules and orders under sections 4, 5, 6 and 7 of TSCA to notify EPA of the country of destina- tion the first time a chemical Is shipped to that country during a calender year. (45 FR 82844, December 16, 1980, 40 CFR 707.60) TSCA §13 Imports — Requires persons who import chemical sub- stances to certify that each shipment Is in compliance with TSCA or is not subject to TSCA. (48 FR 34734, August 1, 1983, 19 CFR 12.118 through 12.127 and 127.28 amended, and 40 CFR 707.20) Future TSCA §8 Rules — This policy also covers all future rules promulgated under TSCA §8 or amendments to the above rul es. ------- -3— DETERMINING THE LEVEL OF ACTION Enforcement alternatives Include a notice of noncompliance, a civil penalty, injunctive relief, criminal action, or some combination of these actions. Notice of Noncompliance A notice of noncompliance (NON) Is appropriate where: (1) the violation is a first-time violation of ISCA § 12 or 13 where there are no other TSCA violations for the shipment or (2) minor violations of TSCA 8 as specified below where the violator has not received a previous NON for a violation of that particular subsection. Violations of ISCA §8 which warrant NON’s are: o Minor technical omissions, I.e., failure to supply required noncritical Information (such as, the phone number of a technical contact). o FaIlure to use certified mall In making a notification (as required by a rule); o Report sent to incorrect address but correctly identified as a TSCA §8(_) submission; o Report sent to correct address but not identified as a TSCA §8(_) submission; Administrative Civil Penalty An administrative civil penalty will be the appropriate response for most violations of these regulations. Concu rrence Civil penalties are to be assessed according to this policy. Regional enforcement personnel must obtain written concurrence from the Office of Compliance Monitoring of the Office of Pesti- cides and Toxic Substances prior to Initiating a civil adminis- trative penalty for TSCA § 8, 12 and 13. Reductions for settle- ment purposes require the concurrence of 0CM as well and must be in accordance with the TSCA Penalty Policy and this ERP. OOOO :i I ------- -4- Each reduction must be justified in the consent agreement and final order and specific dollar amounts attributed to each re- duction. Headquarters may relax concurrence requirements on a Region by Region basis after the Regions have gained experi- ence with actions under these rules and the ERP. Injunctive Action Injunctive action under ISCA may be appropriate in certain circumstances. Although §17 of TSCA can be a very effective tool in obtaining compliance, It is also more resource inten- sive than a civil penalty action. In addition, it has been the Agency’s experience that a civil penalty action is usually sufficient to obtain compliance. For these reasons, the Agency believes that the use of TSCA §17 remedies generally should be limited to those instances where a civil penalty action will not result in sufficiently swift compliance to protect human health or the environment. For example, injunctive action may be used to require a company to maintain records where the atti- tude of the violator indicates that this would not be done otherwise or where there Is a repeated history of failure to keep records. Criminal Sanctions Criminal sanctions pursuant to TSCA §16(b) are the most serious sanctions available for violations of the recordkeeplng/ reporting rules. Accordingly, criminal sanctions may be sought in situations that —— when measured by the nature of the conduct, the compliance history of the subject(s) or the gravity of the health or environmental consequences —— reflect the most serious cases of misconduct. Several factors distinguish criminal cases from administrative or civil actions. First, criminal sanctions will ordinarily be limited to cases in which the prohibited conduct is accompanied by evidence of ugulity knowledge or intent on the part of the prospective defendant(s). TSCA Imposes criminal penalties only for violations of the Act which are committed “knowingly or willful lye. A second factor to consider is the nature and seriousness of the offense. As a matter of resource allocation, EPA will Inves- tigate and refer only the most serious forms of misconduct. Of primary importance to this assessment Is the extent of environmental contamination or human health hazard that resulted from, or was threatened by, the prohibited conduct. Also of significance is the impact, real or potential, on EPA’s regulatory functions. ------- —5— Third, the compliance history of the individual(s) or per- son(s) for a potential criminal case is important. Criminal sanctions become more appropriate as incidents of noncompliance increase. While not a prerequisite, a history of noncompliance will often indicate the need for criminal sanctions to achieve effective individual deterrence. Multiple Remedies There may be unusual instances where a particular situation will present facts that suggest that more than one final action should be taken. 0CM does not encourage the use of multiple re- medies for the reasons discussed below. The purpose of this Section is to outline when multiple remedies are appropriate. Criminal Sanctions Simultaneous civil and criminal enforcement proceedings are legally permissible, United States v. Kordel , 397 u.s. 1, 11 (1970), and on occasion are clearly warranted. These cases should be the exception rather than the rule. When parallel proceedings are contemplated, please refer to the Office of En- forcement and Compliance 1onitor1ng guidance on parallel procedd- ings (January 23, 1984). Notice of Noncompliance In general, a notice of noncompliance should not be used in conjunction with any other final remedy. Where a particular situation presents several violations, some of which would merit a notice of noncompliance, while others would merit civil penalties, no notice of noncompliance should be sent. Instead, an adminis- trative penalty action should be initiated, pleading all viola- tions, with no penalties for minor infractions which would other- wise warrant an NON. Civil Administrative Penalties and Specific Enforcement The criteria outlined in this section antIcipate that civil penalties and specific enforcement (injunctive action) will be used sequentially. There may, however, be instances where the concurrent use of these remedies Is appropriate. If the Region deems this to be appropriate in any case, it should consult with 0CM and OECM before bringing either action. ‘1 ‘\ 1 ‘ ‘- 1¼.J J J..JJ ------- -6- ASSESSING A CIVIL ADMINISTRATIVE PENALTY Summary Back g ro of the Penalty Policy u nd The TSCA Civil Penalty Policy, published In the Federal Register on September 10, 1980, establishes a system tor det er- mining penalties in administrative actions brought pursuant to TSCA §16. Under that system, penalties are determined in two stages: (1) determination of a “gravity based penalty” (GBP), and (2) adjustments to the gravity based penalty. To determine the gravity based penalty, the following factors affecting a violation’s gravity are considered: o The nature of the violation. o The “extent” of environmental harm that could result from a given violation. o The “circumstances” of the violation. These factors are incorporated in a matrix which allows de- termination of the appproprlate gr vity based penalty. Once the gravity based penalty has been determined, upward or downward adjustments to the penalty amount are made In con- sideration of these other factors: o CulpabIlity, o History of such violations, o AbilIty to pay, o AbilIty to continue in business, and o Such other matters as justice may require. The TSCA Civil Penalty Policy system provides a framework for the development of individual penalty guidances for each rule promulgated under TSCA. This document sets forth Agency policy for the use of the GBP Matrix to assess penalties for specific violations of TSCA § 8, 12 and 13 and regulations promulgated pursuant to these sections. ------- —7— App 1 Ic a b lilt y This policy is immediately applicable and should be used to calculate penalties for all administrative actions concern- ing ISCA § 8, 12 and 13 instituted after the date of this policy, regardless of the date of violation. Pending cases should be reviewed to determine whether the penalty calculated under this policy is lower than the penalty In the civil complaint. If this policy yields a lower penalty, an amendment to the com- plaint should be made to substitute the lower penalty. This policy should not be used to raise penalties In existing actions. No case should be settled for an amount higher than the penalty which this policy wouldyield. Calculation of the Gravity Based Penalty Penalties for TSCA § 8, 12 and 13 vIolations vary depending on tne extent, circumstances, whether penalties are to be calcu- lated as one day assessments versus per day assessments, and by capping the number of days for which a violation may be assessed as appropriate. In establishing each of these, the Agency con- sidered the following factors In a comparative manner: o Impact on the Agency’s decision making process. o RelatIve degree of harm caused by failure to comply. o Timeframes In which the Agency decision making process generally occurs. o Time to generate information not reported. ° Relative costs of studies. o Likelihood that sufficient Information is available from other sources. ° Type of Information Involved, I.e., human exposure versus animal toxicity studies and allegations versus actual data. The Gravity Based Penalty (GBP), a function of the nature, circumstances and extent of each violation, Is to be determined by using the following matrix: 000085 ------- -8— EXTENT CIRCUMSTANCES A 1 MAJOR B SIGNIFICANT C MINOR - Levels 1 High Range 2 I $25,000 $17,000 $20,000 $13,000 $5,000 $3,000 3 Mid Range 4 .$ 15,0 00 $10,000 $10,000 $6,000 $1,500 $1,000 5 Low Range 6 $5,000 $2,000 $3,000 $1,300 $500 $200 ‘ After determining the initial or Nbase penaltyu from the ma- trix for the first day of violation, add the penalty for each addi tional day of violation based on the Instructions In the UPenalty for Each Day of Violationu heading. Whether a penalty Is to be assessed as a one day assessment or as a continuing violation on a per day basis Is included In the Circumstances sections. Days of violation are based on calender days, not workdays. Nature A violation may be either chemical control, control—asso- ciated data gathering, or hazard assessment In nature. For pur- poses of assessing a penalty, the nature of a recordkeeplng/ reporting violation Is uhazard assessment. Circumstances The first step in selecting the base penalty is to deter- mine which level on the circumstances axis applies to the violation. The circumstances axis of the GBP matrix reflects the probability that harm will result from a particular violation. For recordkeeplng and reporting rules, violations rank as fol- lows on the circumstances axis: ------- -9- CIRCUMSTANCE LEVEL lEVEL 1 Nonreportlng for TSCA §8(e) Per day Nonreportlng for TSCA §8(e) Emergency One day Incident of Environmental Contamination Nonreporting for TSCA §8(d) Per day Non reportlng for TSCA §8(c) Per day Nonreporting for TSCA §8(a) ChemIcal Per day Specific Rules Nonreporting for Inventory Update One day Nonreporting for Inventory One day Failure to keep records (not TSCA §8(c)] Per day t Failure to record ISCA §8(c) allegatIon One day False/Incorrect/mIsleading reporting Per dayt LEVEL 2 FaIlure to maintain records/report in a One day manner that meets the standard required in the rule. ISCA §8(c) vIolations are level 3. Failure to report under TSCA §8(d) involvIng One day omission of study In list of studies which a manufacturer or processor knows of but which is not in his possession. LEVEL 3 Failure to report completely after EPA has Per day requested missing information or a correc- tion of erroneus information. Failure to maintain TSCA §8(c) records/ One day report In a manner that meets the standard required in the rule. Assess one violation where all allegations are filed but not In the manner presri bed. TSCA §13 VIolation (first or otherwise) One day where a positive/negative/no certification was submitted but the chemical does not com- ply with other TSCA provisions. LEVEL 4 Late reporting — For definition of late Per day t reporting parameters, see the Compliance Monitoring Strategy for each rule. Does not apply to the original Inventory Rule, TSCA §12 and TSCA §13. TSCA §12 violations after company has One day received a previous notice of noncompliance for a violation of TSCA §12. ------- -10- ISCA 13 violations where a negative/no cer- One day - tiflcation is submitted hut the chemical is subject and chemical is In compliance with all other TSCA provisions as specified in the ISCA §13 regulation and the company has received a previous notice of noncompliance for a violation of TSCA §13. LEVEL 5 No violations are level 5. LEVEL 6 MInor technical omission — Example: omitted One day name of technical contact but included title and phone number so the Agency was able to reach the correct person. (See Notice of Noncompliance.) TSCA §8 report sent to incorrect office and One day was not ldentifi•ed as a TSCA §8( ) submis- sion as required. TSCA §8 report sent to incorrect office and One day was identified as a TSCA §8 report after company has received a previous notice of noncompliance for a violation of the same subsection. TSCA §8 report sent to correct office but One day not identified as a TSCA §8 report after company has received a previous notice of noncompliance for a violation of the same subsection. Failure to keep records showing that the One day manufacturer is not subject to reporting under the TSCA §8(a) Inventory Update Rule. Extent The second step In selecting the base penalty for a specific violation from the matrix is to determine its position on the extent axis. This axis of the GBP matrix reflects the extent of potential harm caused by a violation. In the case of recordkeeplng/reportlng rules, harm is defined as the inability of the Agency to carry out its risk assessment responsibilities under TSCA. * One day for Inventory Update, Inventory, TSCA §12, TSCA §13, TSCA §8(e) EIEC’s, and TSCA §8(d) Involving lists of studies which a manufacturer or processor knows of but which are not In his possession. ------- —11— EXTENT LEVEL MAJOR Violations of TSCA § 8(c), 8(d), or 8(e) which involve information which directly Interferes with the Agency’s ability to address situations Involving potential imminent hazard, unreasonable risks, or substantial endangerment to health or the environment .,* Violations of TSCA § 8(d) and 8(e) involvIng human data. Violations of TSCA §8(e) Involving Information on emergency Incidents of environmental contain- in.ation (EIEC). All Circumstance Level 2 vIolations. All Circumstance Level 6 vIolations. SIGNIFICANT Violations of TSCA § 8(d) and 8(e) involvIng animal/aquatic studies, environmental monitor- ing, workplace monitoring (not Invasive human monitoring), and any other study not addressed In the major or minor extent level. Violations of CAIR, PAIR, TSCA §8(a) chemical specific rules, TSCA §8(c), Inventory, and Inventory Update Rule exc.ept Level 2 or Level 6 violatIons. Violations of ISCA §12. Violations of TSCA §13. MINOR Violations of TSCA chemical properties §8(d) InvolvIng physlcal/ or envi ronmental fate data. * This determination must have written concurrence from OPTS. 000089 ------- -12— Per Day Assessments Where per day assessments are provided for in the Circum- stances Level section, the base penalty is calculated for the first day of violation and per day pena1ties are assessed for each subsequent day of violation based on the following fo rmul a: Violations Involvin 9 Potential Imminent Hazard/Substantial Endangerment Si tuat ons/Unreasonable RI SkS Base X Each day of violation = Penalty Penalty TSCA §8(e ) Base + ( No. of days of violation — 1) x base penalty Penalty Penalty 30 ISCA §8(a) Chemical Specific 4 Base + ( No. of days of violation - 1) x base penalty = pena1t * Penalty 360 All others Base + ( No. of days of violation — 1) x base penalty penalty* Penalty 180 * The number of days of violation cannot exceed caps as designated In the following section. Caps on Number of Days for Penalty to be Assessed Per Violation TSCA §8(e) No cap TSCA §8(d) 5 year cap Major Extent Violations 3 year cap Significant Extent Violations 1 year cap Minor Extent Violations TSCA §8(c) 1 year cap ISCA §8(a) 1 year cap Chemical Specific PAIR 1 year cap CAIR 1 year cap ------- -13— Determinfng Number of Violations — Multiple penalties are to be used if there is more than one violation of the same rule or violations of different rules. Violations will be determined as follows: TSCA §8(a) Per Chemical ISCA §8(a) Per Chemical Per Site TSCA §8(a) Per Chemical Per Site TSCA §8(a) Per Chemical Per Site TSCA §8(a) Per Chemical (Per Chemi- Rules cal Per Site If Site—Spe- cific Reporting Is Re- quired) Per Allegation Submitted to Company and Not Filed Per Requirement Not Met Per Firm 1 I nv e n to ry Inventory Update PAIR CAIR Chemical Specific TSCA §8(c) Failure to Keep Records TSCA §8(c) FaIlure to Keep Records as Requl red TSCA §8(c) Report TSCA §8(d) TSCA §8(e) Per Allegation Not Reported Per Study Per Chemical Per Type of Reportable Effect or Event Per Chemi ca TSCA §12 Per Chemical Per Coun- try Per Year TSCA §13 Per Shipment Per Port 000091 ------- -14- Determining the Gravity Based Penalty The circumstances level and the extent category for each violation will define a base penalty in the matrix. For those violations designated as per day In the circumstances matrix, calculate the penalty as Indicated under per day assessments, taking into account the caps on the number of days the penalty is to be assessed. This total penalty should be entered on line 1 of the TSCA Civil Penalty Assessment worksheet and adjusted by the appropriate factors discussed In the ISCA Civil Penalty System and this policy. Adjustment Factors The ISCA Civil Penalty System discusses appropriate adjust- ment factors. In addition, adjustment factors specific to this policy are discussed below.. Voluntary Disclosure (Other Factors as Justice May Require ) The ERP establishes fixed percentage reductions In penal- ties for voluntary disclosure of violations for the following sections only: TSCA 8(a) Inventory Rule, TSCA §12, and TSCA §13. For all other sections, the voluntary disclosure of a violation is to be treated as a late report, and therefore, the violator re e1ves a substantial reduction since the circumstance level moves from Level 1 to Level 4. For TSCA § 8(a) Inventory Rule, 12 and 13, the adjustment factors for voluntary disclosure Is as follows: Disclosure ............................. 25% Immediate disclosure within 30 days of discovery ................... 25% TOTAL 50% The Agency will not consider disclosure voluntary If the company has been notified of a scheduled inspection or the inspection has begun. Information received after these events will be considered as failure to report/file. However, if, for example, an inspector is conducting a TSCA §8 inspectIon at an establishment, and the company voluntarily discloses a TSCA §13 violatIon and the inspector would not have any expectation of discovering such a violation, the TSCA §13 violation would be considered to be voluntarily disclosed. This example would also apply to TSCA §12 vIolations. For TSCA §12 and §13 violations, If a company discloses addi- tional violations during or prior to settlement negotiations, those violations are eligible for voluntary disclosure reduc- tions. The Region may deal with this situation through: ------- —15— 1) an amendment to the original complaint; 2) an additional complaint; or 3) addressIng additional charges in the Consent Agreement and Final Order. Economic Benefit In no case should the final penalty imposed be less than tite economic benefit. In those cases where the initial penalty is less than the economic benefit derived from noncompliance, EPA reserves the right to Impose per day penalties up to $25,000 per day to assure that the penalty is not less than the economic benefit. Exposure Reduction (Other Factors as Justice May Require ) In cases warranting per day assessments of the base penalty, i.e., those involving potential imminent hazard, etc., if the - Respondent has credible evidence by affidavit which shows, for example, exposure has ceased by all routes of exposure, environ- mental and/or commercial; that evidence may be considered to mitigate the penalty. In those cases, the penalty will be as- sessed at the maximum base penalty per day during the duration of the exposure presenting Imminent hazard/substantial endanger- ment/unreasonable risk and assessed as a violation not presenting the potential hazard/risk/endangerment during the time that the hazard/risk/endangerment had ceased to exist. Attitude For ISCA §13 violations, If the company had a system In place to track Import certifications and comply with TSCA §13 requirements, and a chemical “slips through”, a 15% good attitude reduction may be given as provided for in the TSCA Penalty Policy. Larger reductions are inappropriate In that companies are required to comply with certification require- ments and credit should not be given for attempting to comply with the law. If a company experiences numerous occasions where chemicals slip throughu their system, a good attitude reduction Is no longer appropriate. History of Previous Violation The Agency will disregard the firm’s prior history of violations In calculating the penalty for a self—disclosed violation. However, for violations discovered by the Agency, the Agency will address history of prior violations as indi- cated In the TSCA Penalty Policy, even if the prior history results from a violation which was voluntarily disclosed. Q00G93 ------- -16- Explanation of the Penalty Policy Nature TSCA § 8 and 12 require that information concerning chemicals be reported to EPA or kept at the company and made available to the Agency. TSCA §13 requires Importers to certi- fy that chemicals imported are either not subject to TSCA or are in compliance with TSCA. SectIon 8 Information is used by the Agency to evaluate the potential risks associated with the manufacture and use of a chemical. This data gathering often occurs at the early stages of regulatory decision making. Therefore, complete and accurate information Is essential, incomplete and Inaccurate information will have far-reaching effects on the Agency’s risk assessment, regulatory priority setting, and regulation development processes. Some information such as TSCA §8(e) information may affect the Agency’s ability to inittate Immediate action necessary to pro- tect health and the environment, e.g., seeking injunctive relief. In addition, reports under the original Inventory Reporting Rulif establish the basis for what is an “existing” chemical versus a “new” chemical, the latter being those for which a premanu— facture notice must be flied and the chemical reviewed by the Agency. Section 12 collects information about the export of chemicals subject to certain proposed or final testing or regulatory require- ments under TSCA § 4, 5, 6, or 7. The Agency provides this Infor- mation to the government of an Importing country to allow that country to Initiate Its own risk assessment process. The section 13 rule describes procedures for certifying that imported chemical substances subject to TSCA are In compliance with ISCA. This information permits the Agency to determine if importers of chemicals are complying with applicable TSCA regula- tions. Circumstances The circumstances axis of the GBP matrix reflects the probability for harm resulting from a particular violaton. For the reporting rules, the potential harm caused Is the harm to the Agency’s regulatory program for controlling health and environmental risk. For violations of the original Inventory Reporting Rule, the potential harm is that a new chemical may be produced with no prior review contrary to the Intent of TSCA because an Inventory Rule violation resulted in a chemical being placed on the Inventory which was not an “existing” chem- ical under TSCA. For chemicals which other persons also reported, the harm deals with the Information on the estimated produc- tion volume and sites of manufacture which the Agency uses in its risk assessments, including those for TSCA §4 test rule decisions. For section 12 reportiny, the potential harm Is ------- —17— to the Agency’s ability to carry out its responsibility to notify other countries. Thus, violations have the potential to also harm another country’s regulatory program. 1igh Range Violations — Level 1 Nonreporting/failure to report or to keep records Is an extremely seflous violation of these rules. The Agency will have to proceed with che ’iica1 assessment and priority setting, and perhaps, even regulation development, especially for TSCA §4 test rules, without critical information or without the knowledge that such informaton even exists. This is true even If a company reports some information but does not report each study or under- reports the extent of health effects or number of allegations for a particular effect. Thus, each report omitted or incompletely reported will be treated as a separate nonreporting violation. False/Incorrect/mIsleadIng reporting of information Is equally harmful because the Agency Is misled In Its analysis of the potential risks posed by the chemical or In the amounts or types of Information available. TSCA §8(c) violations In level 1 Include failure to keep records and failure to report If the Agency has requested that the Information be submitted. Thus, If a company has received TSCA §8(c) allegatIons, but does not maintain TSCA §8(c) records, and the Agency requests that TSCA §8(c) allegations be submitted and the company falls to make a submission, there are two viola- tions - one for the failure to keep records and another for the failure to report. Even if a company submits most allegations but not all, each failure to submit an allegation shall be separately charged and assessed as a failure to report. ISCA §8(d) level 1 vIolations Include the following: - Failure to submit unpublished studies in the manufacturer’s, Importer’s or processor’s possession. — Failure to notify EPA of unpublished studies the manufacturer, importer or processor knows of but is not In possession of. - Failure to notify EPA of ongoing studies which the manufacturer, importer or processor Initiated or sponsored. Includes future studies required to be reported once they are Initiated. - Failure to send EPA the final report of a study which was listed as an ongoing study. Includes future studies required to be submitted. 000095 ------- -18- Failure to submit underlying data to EPA on EPA’s request. Failure to comply with the TSCA §8(e) reporting requirements is potentially the most serious violation of TSCA §R. TSCA §8(e) reports alert the Agency to new information which may have a hearing on the Aqency’s regulatory efforts. This ERP reflects thp seriousness the Agency attaches to violations of TSCA §8(e) by placing no caps on the penalties assessed for these violations. High Range Violations — Level 2 Failure to maintain records or report in a manner that meets the standard required by the rule has effects similar to falsi— fled Information. Both mislead the Agency nd are difficult to detect. Failure to report In a manner that meets the standard refers to those cases where reporting Is essentially complete and the missing/incorrect information does not impact the report In such a manner as to mislead the Agency. An example is the failure to report one ongoing ISCA §8(d) study when another similar study is reported by the company. Another example Is a small error in reporting production volume, I.e., less than an order of magnitude (a factor of 10). Level 2 also includes a TSCA §8(d) violatIon involving the failure to report a study which a manufacturer knows of but which Is not In his possession. The Agency considers this violation to have less potential harm than other failure to report violations since the Agency Is likely to learn of this study from other persons reporting. Mid Range Violations - Level 3 Failure to report completely after EPA has requested missing information is a significant violation. Such a violation denies the Agency access to Information necessary to Its analysis of chemical risks. This type of violaton is not as serious as the high range violations because it is usually relatively easy to detect and therefore easy to remedy. A form, for instance, will have blank spaces where answers are expected. Even though the Agency does not have the Information, it knows that an Information gap exists, and therefore, is less likely to be misled into making invalid chemical risk assessments. However, the withholding of Information is a serious Impediment to risk assessment, and If It becomes a widespread practice, it could significantly affect the Agency’s chemical risk assessment processes. Thus, thIs vio- lation, while not as serious as a total failure to report or false or misleading reporting, is still of sufficient severity to be treated in the higher level of the midrange. ------- -19- For ISCA §8(c) files, the failure to maintain reports as required In the rule, e.g., files which are present but which are not cross—indexed or which are not kept in one location, in- volves a level 3 vIolation. in those cases where the company files this InformatiOn’, and the Agency requests the Information to be submitted, and information Is not submitted because the company’s files result in the information not being discovered during the company’s fil-e search, the failure to submit is a level 1 vIola- tion. The company may also be charged with the level 3 vIolation. Please note that failure to file an allegation under TSCA §8(c) although other allegations are filed constitutes a level 1 failure to keep records violation. Another level 3 violation Involves ISCA §13 violations where there is a positive/negative/no certification and the chemical is in violation of other ISCA provisions. TSCA §13 is designed to assure that an importer takes affirmative responsi- bility in assuring that his shipments comply with TSCA. Where other TSCA violations are found, a level 3 vIolation will be assessed plus appropriate penalties for the other TSCA violations. Mid Range Violations - Level 4 Reports which are late can significantly slow or disrupt the Agency’s decision making process. The exact timing may vary on a rule by rule basl which will be discussed In the Compliance Monitoring Strategies. Lateness is classified In the lower level of the midrange circumstances category. In addition, the Agency has decided to treat reports which are submitted late as late reporting regardless of the date of submission, with the exception of reports for the original Inventory Rule and TSCA § 12 and 13. ThIs decision has been made to encourage the voluntary disclosure of violations by assessing penalties as level 4 instead of level 1. For the original Inventory Rule and TSCA § 12 and 13, a reduction Is provided for the voluntary disclosure of violations. Reports submitted or violations disclosed after EPA has notified a company of a scheduled inspection will be treated as level 1 failure to report violations, except as otherwise indicated in the Summary of the Penalty Policy. TSCA §12 violations other than the first violation are categorized as level 4. The Agency considers TSCA §12 report- Ing to be Important to its ability to notify other countries to which chemicals subject to TSCA rulemaking are being exported. The potential harm is not to the Agency’s decision making process but to its statutory obligation to notify other countries. 000097 ------- -20- The Agency considers TSCA §13 vIolations, other than the first TSCA. §13 violation for which there are no other TSCA viola- tions, to be mid range level 4 violations. Even if no actual harm occurs, the violation reflects the importer’s failure to assure full compliance with ISCA. Failure to certify or filing a false certification on each shipment circumvents the purpose of TSCA §13 and could lead to the importation of chemicals which violate -other provisions of TSCA. low Range Violations — Level 6 There are no violations which fall within level 5. level 6 violations Include minor technical omissions which do not affect the Agency’s ability to follow up the Information either by contacting someone In the company or consulting outside references. They are among the least ser’ious because the violation Is readily detected, does not affect Initial risk assessment and may only slightly hinder the Agency’s decision making process. In cases where there Is no effect on the Agency, a notice of non- compliance rather than a penalty may he appropriate. However, If a company repeats this type of violation, the Agency will assess a penalty. Another level 6 violation Is the failure on the part of a manufacturer to keep records showing that he Is not subject to reporting under the TSCA §8(a) Inventory Updat Rule, which requires persons who produce less than 10,000 lbs. of a sub- stance to maintain records documenting that fact. Other low range violations Include a submission of ISCA §8 informatIon which Is not identified as TSCA §8( ) information and which is not sent to the correct oTfice. Also, submitting the Information to the Incorrect office or not correctly identifying the Information after a previous Notice of Noncompliance has been issued for a violation of that section warrants a level 6 assessment. Although the Agency receives the information, It may take some time to reach the correct office or to be placed Into the review process, and therefore, the Agency’s decision making Is delayed or Impeded. Extent This factor reflects the extent of potential harm to EPA’s hazard/risk assessment process. The Agency relies on information gathered under sections 8(a), 8(c), 8(d), and 8(e) to perform risk assessments. The Agency uses TSCA § 12 and 13 in a different way. TSCA §12 information is used In order to notify foreign governments. TSCA §13 is used to assure that Importers verify and certify compliance with TSCA. ------- —21— For risk assessment, information may be related to toxi- city or exposure, both important in determining risk. In examining the extent of potential harm, the type of Information is Important, i.e., human effects data, human exposure data, animal data, environmental effects, actual environmental con- tamination information. Also, scientific studies versus allegations differ In their importance. Major Extent Violations which directly Interfere with the Agency’s ability to address potential imminent hazard, unreasonable risk, or 5UbStafltial endangerment to health/environment are placed In the major extent category. This criteria Is appli- cable to TSCA 8(c), 8(d); and 8(e). Examples of these types of violations include: 1) information on Injury to humans where continued manufacture or use poses a potential Imminent hazard; or 2) InformatIon on a spill/dumping which Is covered by TSCA §8(e) and which posed(s) an Imminent hazard or results in widespread environmental contamination to which persons. exhibit serious health effects. In the second case, two violations would be charged, one for the failure to report the spill and another for the failure to report the health effects. Other major extent categories include TSCA § 8(d) and 8(e) violations involving information on human effects. Such infor- mation can weigh heavily in the Agency’s decision making process. Also, violations Involving emergency incidents of environ- mental contamination reportable under. TSCA §8(e) are considered to be of major extent since the Agency needs such information Immediately. Otherwise, the opportunity to. provide adequate protection may be lost. All level 2 and level 6 vIolations are placed in the major extent category. Significant The Agency places slightly less Importance on animal studies as opposed to data reporting effects In humans. Nonetheless, such information Is critical to the Agency’s decision making process. Such tests may be expensive, may take a long time to 000099 ------- -22- conduct, and require rulemaking by the Agency to obtain them. For example, If a company fails to report a study it has, the Agency may decide that such data are needed and proceed to do unnecessary rulemaking under ISCA §4. Given the time for Such rulemaking and the time needed to conduct tests and submit re- sults to the Agency, the violation results in a major delay in the Agency’s risk assessment of the chemical and an unnecessary expenditure in resources, both EPA’s and industry’s. Please note that failure to report a study which is required to be re- ported but which indicates no adverse effects of the chemical still results in this harm. The Agency has also decided to place violations Involving exposure related data in the significant category when the EPA has made a decision that it needs Such information for a specific chemical. Thus, ISCA § 8(d) and 8(e) violatIons involving exposure related.lnformation as well as violations of the CAIR, PAIR, and TSCA §8(a) chemical specific rules,-. all of which involve exposure related Information, are consid- ered to be significant category violations. Although exposure Information Is critical to any risk assessment, the impact on the Ageny’s decision making if one company fails to report and all other companies comply is less than if one company falls to submit a toxicity study since it is less likely that another company will submit the same study. This distinction Is reflected in the establishment of caps for different types of violations. TSCA §8(c) Involves allegations and not actual test data. However, such information is important to the Agency’s decision making process in that it involves patterns of effects and generally involves human effects. Therefore, these violations are categorized as significant. TSCA §8(a) Inventory and Inventory Update Rules are also designated as significant. Although information under these rules Is not required as a result of the Agency identifying a specific need for information on specific chemicals, this Information provides exposure related Information which is important to the overall decision making of the Agency in ternis of setting its priorities and deciding what rulemaking to pursue. TSCA §12 violations are also considered significant since such information is necessary for EPA to carry out its responsi- bility to notify other countries of chemicals for which EPA has taken certain actions, I.e., a TSCA §5 order or a final or proposed TSCA § 4, 5 or 6 rule. TSCA §13 is significant in that violations hinder EPA/Customs’ ability to monitor ship- ments for compliance with ISCA. ------- —23— 141 nor Two types of violations fall Into the rilnor extent level, i. ., violations of TSCA §8(d) involvinq physical/chemical propertiøs r environmental fate data; and violations of TSCA §8(a), failure to keep records showing that a manufacturer is not subject to reporting under the Inventory Update Rule. The TSCA §8(d) violations are categorized as minor based on the relatively low costs of such studies and the time it takes for the study to be conducted. The TSCA §8(a) violations are easy to detect upon inspection and information the company should already have. Per Day Penalties or One Day Assessments The Agency has elected to use one day assessments for violations of rules which require reporting for all chemicals meeting certain criteria (such as exceeding a given production volume per site) as opposed.to Information which is not being requested on a chemical specific basis. In other words, one day assessments are appropriate In cases where the Agency uses the information to set priorities and may use It as the need arises on a specific chemical evaluation but has not affirma- tively identified a particular chemical for which specific information is needed. In those cases where EPA has Issued a rule which lists a specific chemical(s), per day assessments are appropriate because the Agency has identified a need for the Information for risk identification, risk assessment, or risk management purposes. Per day assessments also apply to any TSCA §8(e) InformatIon (except EIEC’s which do not meet the potential imminent hazard/ endangerment criteria). Although the Information Is not being requested for a specific chemical, it Is likely to be used Immediately for risk assessment purposes. Per day assessments are made for those violations where the continuing violation continues to Impede the Agency’s decision making process. One day assessment Is appropriate for a failure to list a TSCA §8(d) study which a company knows of but which is not In its possession. Level 2 and level 6 violations are to be as- sessed as one day. Also, TSCA § 12 and 13 are considered to be one day violations. As with TSCA §8(e) vIolations dealing with an EIEC, violations of these rules do not impede the Agency’s regulatory decision making process in that such infor- mation would not normally result In rulemaking. However, such information Is necessary for more Immediate actions such as injunctive relief or seizing chemicals which are otherwise in violatior. of TSCA, e.g., a TSCA §13 chemIcal imported in viola- tion of TSCA §5. Violations involving TSCA §8(c) files, I.e., failure to record information, are treated as one day violations because the effect on the Agency’s decision making is not critical 000101 ------- -24- until the Agency requests the submission of TSCA §8(c) informa- tion. Once the information is requested, the Agency has a specific need for the information to make Its decisions. There- fore, “failure to report” violations under TSCA §8(c) are as- sessed on a per day basis due to their adverse impact on the Agency’s decision making. Per Day Assessment Calculation For violations Involving TSCA §8(e) InformatIon which dIrectl, interferes with the Agency’s ability to address situations in- volving potential Imminent hazard, unreasonable risk, or substan- tial endangerment to health/environment, the base penalty is to be assessed for each day of violation. These are the most serious violations, and therefore, warrant the highest penalties provided for by the statute. For other TSCA §8(e) violatIons, the base penalty Is to be used for the first day of violation. For each day thereafter, the per day penalty Is the base penalty divided by 30. ThIs ad- justment was selected for the following reasons: 1) these viola- tions involve significant adverse effects; 2) the Agency has an Immediate need for the information in order to protect the pub— I lic and env.ironment, as reflected In the statute’s language to “Immediately notify”; and 3) the timing of the Agency’s decision making process once such data Is received. For TSCA § 8(c) and (d) violations for which per day assess- ments are to be made, the base penalty Is to be used for the first day of violation and for each day thereafter, the per day penalty is the base penalty divided by 180. For TSCA §8(a) ChemIcal Spe- cific violations the per day penalty Is the base penalty divided by 360. This method was selected In order to provide further distinction between types of violations and their impact on the Agency’s decison making process and Its mission to protect the public and the environment. Caps In establishing caps for some violations, the Agency took Into account factors such as the ‘ength of time that a v1o at1on continues, the timing of the Agency’s decision making process, the relative costs of studies and the length of time needed If unnecessary studies are conducted. Please note that the cap does not refer to a limitation on the time elapsed since the violation occurred — only a limit on the number of days for which a penalty Is assessed even though a violation continues for a longer period. There is no cap on TSCA §8(e) violatIons. The harm continues as long as the violation continues. For TSCA §8(d) studIes, which often relate directly to ISCA §4 rulemaking, the caps depend on the type of study, the length of time to conduct the study, the relative costs of the studies, and the timing of the Agency’s decision making. ------- -25— For other TS.CA §8 vIolations for which per day assessments are to be made, a one year cap is set based on the estimated time of the Agency’s decision making process. This decision also reflects the fact that TSCA §8(a) requirements are more exposure oriented than toxicity oriented, and therefore, the quality of the information is sensitive to time. As indicated in the discussion on extent categories, exposure Information is important but one company’s failure to report may not have as much of an impact as nonreporting of toxicity information because the exposure information is used in the context of total exposure. Therefore, these violations are capped at one year. A chart Is provided in Appendix I which indicates the caps per violation and their maximum assessments. Caps refer to maximum penalties for each separate violation; they are not cumulative caps for multiple violations. Determining Plumber of Violations The number of vlolatibns depends on the requirements which are in each rule. Multiple violations are to be assessed when- ever more than one rule Is violated and for each violation within a rule. TSCA §8(a) Inventory violations are assessed for each chemical for which there Is a violation-. The Inventory Update I rule requires reporting for each chemical and for each site. Therefore, TSCA §8(a) Inventory Update violations are assessed per chemical per site. Violations of CAIR and PAIR are assessed per chemical per site. TSCA §8(a) Chemical Specific Rules violations depend on the information required by the rule. If the rule requires site specific information, then violations are assessed per chemical per site. If the rule requires aggregate information for each company, then violations are assessed for each chemical not reported/otherwise in violation. ISCA §8(c) violations are determined depending on the viola- tion. TSCA 8(c) ufailure to keep records violations and “failure to report” violations are assessed per allegation not maintained/ reported. This is because the omission of any allegation may Impact the Agency’s decision making process, especially If there Is significant underreporting of allegations. However, a “failure to keep records as required under TSCA §8(c) is assessed per plant site because these violations Involve files not maintained as prescribed but for which the information Is available. An alle- gation consists of each report (I.e., one or more pieces of paper) whereby an lndividual/ group submits an allegation to a company. If one person alleges that six chemicals produced ten effects In the same report, and the company fails to file the allegation, this is assessed as one violation. If two persons file separate reports regarding the same health effect, and the company does not file the allegations, this constitutes two violations. If 000 03 ------- -26- a union files a report for 100 persons regarding an allegation, and the company does not file the allegation, this is assessed as one violation. • TSCA §8(d) violatIons are assessed for each required study. The omission of a single study even If others are submitted may have a serious impact on the Agency’s decisions regarding a specific chemical. TSCA §8(e) violations are assessed per type of effect per chemical not reported. Omission of one significant adverse effect even If other effects are reported impedes the Agency’s risk assessment. TSCA §12 violatIons are assessed per chemical per country per year not reported. This decision was based on the determina- tion that the export notiftcatlon requirement Is a one-time requirement per year for each chemical and for each country of export. That is, the first time a chemical Is exported to a country, t-he exporter must notify the country. Subsequent exports of the same chemical during the same calendar year to the same country do not require notification. TSCA §13 violatIons are assessed per shipment per port because the U.S. Customs regulation requires a certification for each shipment, not for each chemical within a shipment. If the same chemical is imported on the same day to a port In three separate shipments, there are three violations. Adjustment Factors Voluntary Disclosure The Agency considers It important to foster voluntary disclosures of violations for ISCA § 8, 12, and 13. Most dis- closures of TSCA §8 violatIons will be treated as late reporting and subject to level 4 instead of level 1 penalty assessments, which provides a voluntary disclosure Incentive. For TSCA §8(a) Inventory violations and TSCA § 12 and 13 violatIons, explicit reductions for voluntary disclosure are also provided. It is Important to foster voluntary disclosure of TSCA §8(a) Inventory violations in order to remove chemicals from the Inventory which were placed there Illegally. Once the Agency knows of this, It it can act to correct the violation. Similarly, if violations of TSCA § 12 and 13 are brought to the Agency’s attention, It can act to remedy the situation, e.g., foreign countries can be notified or imports In violation of other sections of TSCA can be Identified and appropriate action taken. Also, EPA wants to encourage companies to conduct self- audits and report violations. ------- —27— History of Noncompliance As a further Incentive for the voluntary disclosure of violations, the Agency has decided to forego the imposition of penalty increases for a previous history of noncompliance in assessing penalties for voluntarily disclosed violations. However 1 a voluntarily disclosed violation does constitute a history of violation and is to be used to increase penalties for future violations which the Agency discovers. ISCA Section 13 - Who Issues Notice of Noncompliance/Penalty and to Whom TSCA §13 may involve imports in one Region by an Importer of record, who Is located in another Region and who uses a broker. The Notice of Noncompliance/Penalty Is to be issued to the importer of record, not the broker, and by the Region In which the importer of record is located. This Is consistent with the Inspection Guidelines. This decision was made for several reasons. If a TSCA §5 inspection Is conducted at the importer of record’s business, and there Is a chemical which has been imported Into three ports In three other Regions and which is not on the inventory, It is more efficient to issue a Civil Complaint for the one ISCA §5 violation and three TSCA 13 violations than to Issue four sep- arate Civil Complaints In four Regions. A second reason pertains to the location of the hearing. If one Region Issues the complaint to an importer of record in another Region, there is a problem of travel , both in terms of time and money, since the hearing will likely be held In the Region where the Importer of record is located. A third reason deals with the tracking of Notices of Non- compliance between Regions in order to know If a company has received its first TSCA §13 NotIce of Noncompliance and Is therefore subject to penalties for subsequent violations. 000105 ------- APPENDIX 1 CAPS FOR PER DAY VIOLATIONS ------- APPENDIX 2 EXAMPLES ------- CAPS FOR PER DAY VIOLATIONS ALL CAPS ARE PER VIOLATION TSCA §8(e ) --No Caps ISCA §8(d ) Nonreporting/False Reporting Major, level 1 — $278,333 — 5 yr. cap Significant, level .1 — $120,322 — 3 yr. cap Minor, level 1 — $15,111 — 1 yr. cap Late Reporting Major, level 4 - $111,333 — 5 yr. cap Significant, level 4 - $42,467 — 3 yr. cap Minor. level 4 — $3,022 — 1 yr. cap TSCA 8(c ) Nonreporting/False Reporting — 1 yr. cap Significant, level 1 — $51,378 Late Reporting — 1 yr. cap Significant, level 4 — $18,133 TSCA §8(a) Chemical Specific rules Nonreporting/False Reporting — 1 yr. cap Significant, level 1 — $34,189 Late Reportlng•— 1 yr. cap Significant, level 4 — $12,067 000107 ------- —2— TSCA §8(a) Inventory and Inventory Update Example 1 — A company fails to report a chemical on the TSCA Inventory. EPA discovers the violation. Failure to report, level 1, significant, one—time penalty. Failure to report — $17,000 Example 2 — A company fails to report a chemical on the TSCA Inventory. The company Is bought by another company who, upon checking records, discovers the failure to report and immediately notifies the Agency. Failure to report, level 1, sIgnificant, one—time penalty. Failure to report — $17,000 Voluntary Disclosure Policy — 50% reduction of penalty. Amended Penalty - $8,500 Example 3 - A company fails to report 1 chemIcal at 4 dIf- ferent sites for the Inventory Update. The company Is bought by another company who, upon checking records, discovers the’ failure to report and Immediately notifies the Agency. Late reporting, level 4, signIficant, 4 counts, one—time penalty. Late reporting, 4 counts — $24,000 TSCA §8(c ) Example 1 - A union contacts EPA complaining that they submitted 1 report to the company regarding health effects to 10 workers due to their exposure to chemical X. The report was presented to the company In accordance with the rule, and the union provided acknowledgments of receipt by the company. EPA requested the company to provide all allegations of health effects due to exposure to chemical X. The company failed to respond. EPA Inspected the com- pany’s TSCA §8(c) fIles six months later and found none. Failure to keep files, level 1, signifIcant; and failure to report, level 1, signIficant. $17,000 + $17,000 + 180 X $17,000 = $51,000 180 Failure to maintain a file $17,000 Failure to report (per day penalty) $34,000 181 days ________ Total 51,O00 ------- —5.. Example 5 — A company submits a list of studies known to them but not in their possession. The Agency discovers that the company failed to list a study they had knowledge of. Failure to report a study the manufacturer knows of but is not in his possession, level 2, major, one day assessment, ‘no per day penalty. $20,000 TSCA §8(e ) Example 1 — time period violation. assessment — A company failed to report a spill within the prescribed in the policy. EPA discovers the Failure to report, level 1, major, one—time $25,000 Example 2 - kcompany failed to report a spill within the time period prescribed in the policy. The company reports their failure to EPA a year after the spill occurs. Late reporting, level 4, major, one—time assessment — $10,000 Example 3 — A company fails to report a study showing human health effects. EPA discovers the violation. Failure to report, level 1, major. Discovered after 361 days — $25,000 + 360 X $25,000 = $325,000 30 Discovered after 1,081 days — Discovered after 3,601 days — $325 ,000 $925,000 $3,025,000 Example 4 — A company fails to report a study showing animal effects not previously reported. The company later submits it to the Agency. Late reporting, level 4, signifIcant. Reported after 361 days — $6,000 + 360 X $6,000 = $78,000 30 $78,000 Reported after 1,081 days — Reported after 3,601 days - $222,000 $726 ,000 000113 ------- —6— Example 5 — A company submits a study to EPA showing new animal effects. An inspector conducting an inspec- tion of the company later discovers reportable information which was omitted from the study. False reporting, level 1, signIficant. Di scovered after 1,825 days — $1,050,600 $17,000 + 1,824 X $17,000 $1,050,600 30 Discovered after 365 days — $223,267 Discovered after 3,650 days — $2,084,767 Example 6 — A company fails to submit human health effects information which is later characterized by the Agency as showing a potential Imminent hazard. EPA discovers the violation 90 days after the report was due. Failure to report, level 1, major. Potential Imminent hazard finding, $25,000 per day penalty. $25,000 X 90 $2,250,000 EPA discovered the same violation after one year. $25,000 x 365 $9,125,000 EPA discovered the violation after one year and the company presents credible evidence that exposure ceased after 90 days of the due date of the report. The penalty Is calculated as an imminent hazard for 90 days and as a reduced per day for the TSCA §8(e) failure to report for the period thereafter. $25,000 X 90 $2,250,000 275 X $25,000 = $229,167 $2,250,000 + $229,167 • $2,479,167 TSCA §12 Example 1 — An exporter which has received no previous TSCA §12 Notice of Noncompliance exports 30 chemIcals to 30 coun- tries with no notifications. Failure to notify. Notice of Noncompliance. ------- —7— Example 2 - An exporter who has previously received a Notice of Noncompliance for a TSCA §12 violation exports one chemical to one country 30 times during one calendar year with no notifications. Failure to notify, level 4, signIficant. — 6 ,000. Example 3 — An exporter who has previously received a Notice of Noncompliance for a TSCA §12 violation exports one chemical to one country 30 tImes during one calendar year, notifying EPA that 5 shIpments had already occurred. Failure to notify, level 4, significant, voluntary disclosure, more than 30 days since discovery, 25% reduction. — $4,500 Example 4 - An exporter who has previously received a Notice of Noncompliance for a TSCA §12 violatIon exports the same chemical tO 30 countrIes with no notifications within the same year. Failure to notIfy, 30 counts, level 4, signIfi- cant. $180,000 Example 5 - An exporter who has previously received a Notice of Noncompliance for a TSCA §12 vIolation exports the same 30 chemicals to 30 countrIes with no notifications within the same year. Failure to notify, 900 counts, level 4, signIfi- cant. - $5,400,000 TSCA Section 13 Example 1 - Company Imports a chemical with no certification and which is otherwise in compliance with TSCA. Failure to certify, level 4, signifIcant. First time violation: NON Second time violation: $6,000 Example 2 - Second time violator Imports a chemical which is otherwise In compliance with TSCA at 3 ports on the same day but has no certification or an Incorrect certification. Failure to notify, level 4, signifIcant, 3 counts — $18,000 Example 3: Second time violator Imports 3 shIpments of a chemical which Is otherwise In compliance with TSCA on the same day to the ‘ame port. Failure to notify, level 4, significant, 3 counts — $18,000 Example 4 — Second time violator imports 30 shIpments which are otherwise in compliance with TSCA but lack a certification. Import may be to same port or different ports. Failure to certify, level 4, signifIcant, 30 counts. $180,000 000! 15 ------- D ------- Information Gathering I1C Recwnmendaiions §Se Submissions §21 l u iisions Literature Se.ir bes 4 Published Data PAlR (ITC), §8a Reports IIUR §8d (ITC) Problem Characterization Drop or §4 Test Data Negotiated Test Data NTP Test Data §Sa Repor’sr CAIIL. IIJR. Chcm-Spc iIii Drop or CALR. IUR. §8a Reports Chem.Spccific 8&1 Reports §Se Submissions §5 SNUIL, §tkl Reports §8c Call Ins §Se Submissions w Risk Analysis/Risk Management Process 7 Entry Review I I Risk Assessment 7 Drop or Risk Management r ItLII-r lLkr Re(er ------- E ------- ,4 eg ,/i h TOXIC SUBSTANCES CONTROL ACT (TSCA) PL94-’-469 CANDIDATE LIST OF CHEMICAL SUBSTANCES VOLUME I SUBSTANCE NAME SECTION (PART 1) T’”’ ” “i” APRIL 1977 TSCA INVENTORY (On Microfiche) U.S. ENVIRONMENTAL PROTECTION AGENCY OFFICE OF TOXIC SUBSTANCES WASHINGTON D.C. 20460 ------- PREFACE The Toxic Substances Control Act (TSCA), Public Law 94-469, re- quires the U.S. tnvironmental Protection Agency (EPA) to comnile, keen current, and publish a list of each chemical substance which is manu- factured, imported, or processed in the United States. Chemical sub- stances not appearing on the inventory will be considered new chemical substances and will be subject to review by EPA, under the nremanufac- turing notification provisions of TSCA, prior to their manufacture or processing for comercial purposes. Using the authority of Section 8 of TSCA, EPA intends to comDile the inventory from reports prepared and submitted to EPA by manufac- turers and processors of chemical substances. On March 9, 1977, EPA published in the FEDERAL REGISTER (42 FR 13130) proposed rules and draft reporting forms for compilation of the inventory. These rules are scheduled for promulgation In final form by June 30, 1977. Each chemical substance or category of substances which appears on the inventory will be listed with a Chemical Abstracts Service (CAS) Registry Numbers In the near term, these numbers for specific chemical substances should simplify both the reporting and compiling of such substances for the Inventory. Eventually, these numbers may serve to index additional information concerning each substance in a comouter- based data retrieval system. The following TSCA Candidate List of Chemical Substances prepared by the Chemical Abstracts Service contains over 30,000 chemical sub- stances with their CAS Registry Numbers. The puroose of the Candidate List is to assist manufacturers and processors in identifying chemicals which they must report. Although the list does not Include every chem- ical substance manufactured or orocessed for conii ercla1 purooses, It is quite comprehensive and contains all the information needed to identify those substances contained therein for the Inventory. For chemical substances not identified on the TSCA Candidate List, a manufacturer must provide a detailed description of each substance so that an apnro- priate CAS Registry Number may be assigned. Manufacturers and proces- sors are therefore encouraged to consult carefully the Candidate List to simplify compliance with the EPA inventory reoorting requirements. Published in three volumes, the TSCA Candidate List has been arranged Into four sections, each of which provides a different means of locating chemical substances. Volumes I and II contain the Substance Name Section, an alphabetical listing of systematic chemical names and synonyms for substances on the Candidate List. Volume III has three parts. The Formula Section orders substances with known chemical con- stitution by molecular formula. The CAS Number Section lIsts substances by CAS Registry Number. Finally, the Chemical Substances of Unknown or Variable Composition, Complex Reaction Products, and Biological 1ateria1s (UVCB) Section presents chemical substances that do not have specific molecular formula representations. This Section is organized In subsets ------- — 11 — of closely related substances. The hierarchical listing of subset headings printed as a preface to the UVCB list should help manufacturers locate chemical substances included under one or more of the subset headings of the list. Only those substances listed with CAS Registry numbers and not the subset headings are Candidate List chemical sub- stances. EPA recognizes that some of the chemical substances listed in the Candidate List could be more precisely described. Specifically, some of the entries in the UVCB Section such as asbestos, tar, or humic acids, could be refined. As stated in the proposed inventory reporting regula- tions, EPA intends to revise any category on the inventory as appropri- ate based on information obtained through Section 8 of TSCA or other sources. Also, the categorization of chemicals for compilation of the inventory in no way prejudges how chemicals might be categorized for implementing other sections of TSCA. A draft Guide to the Use of the TSCA Candidate List has been published in the FEDERAL REGISTER. The guide explains the meaning of the various informational entries contained In this list, further de- scribes the organization and content of each section of the list, and elaborates on instructions for reporting chemical substances for the inventory. EPA has solicited coninent concerning the clarity o.f the guide and plans to make any necessary revisions and publish it along with final inventory reporting regulations in June 1977. Finally, some minerals which appear in the TSCA Candidate List of Substances a’so are included in Appendix A of the Candidate List. EPA published in the FEDERAL REGISTER a list of “Minerals Currently Under Consideration for Inclusion in Appendix A of the Candidate List.’ Based on coments received on this list, EPA will publish Appendix A with the final inventory regulations In the FEDERAL REGISTER. Consistent with the proposed regulations, minerals specifically designated in Appendix A of the Candidate List need not be reported as they will be automatically included on the inventory. ------- CA, 0011V - nc uc CIM U II * u S ________ - -——i ssl4 Da s &Jaaiss I . N UI WI*M POS& ’IOH. M R0JIM uiA — -S I $W I IM IOW ’ N 10 *0 1 DS CIC SS CAflDN 11 O liI M $UISV*N 0 *n UDI.WI . • a. • • — — . ; —. ___________• • • .—. •. .. V —. •— - “U’ 4 N - - ::——-- — --- —4 — 037 , - i ,, .. _____ *13)41 *7 .• MS)4 S3 • . . . c 1 i 1 .. 2 — — - — . —• .• .—• . . * _ .- .. . “ -—.• - 1 , -•-——---• i • . -•.•, .. .1-.• - • — — ‘— -- — _._-___ _--o• : - ‘ I - —. • -— ——‘ -•—. --- - •. ‘- . .. j ‘—.. - • ..,• • .- a !#-r%#—I?.—’ I •I. . •. _]_ ..—. :‘ ‘I • •.’ .:,. •,..• •; “q, s.;’ I . ii 3 I I I I I 2’ I , I I’ 1’ I, I I , I • 0 .‘ co.esimias M a IMV I,.,,, r 2 • osa as IuWN C • mav S 1 I 4I 1l Il - = — - - ___ - • • • - ‘ S.. • — — • .L • • • • • -.:.j .. • ..• • .•‘ ::•: _- . _ . - :‘ — • • •:, • S . • •. .• .• •. .. • — • -v —-r - • ••.. . -.• I —— - • . .• . .• -V - • - ,. • • 4 •. V• — . —•. S - ._.• t . — . • • . • •; • •• • • • . • •..• . . . — . . • —. • • • : .I -w -—e - • 5i. • I C p ‘ S S 1 I —i Ii ;j. -S . -,- a U I I 1 C I S ‘ S S 1 I I q 32180499 I I . 5 S I 1 :2 ------- TOXIC SUBSTANCE CONTROL AC! CI’SCM CHEMICAL SUBSTANCE INVENTORY VOLUME I TSCA INVENTORY: 1985 EDiTION Jinuary 1108 U.S v ,vmminta1 PrcCmc c Agi cy om . i & b sacus Wh ngt , D.C. 10490 ------- TOXIC SJBSTANC CONTROL AC’F (‘iSCA) CHEMICAL SUBSTANCE INVENTORY TABLE OF CONTEN’IS VOLUME I TSCA INVENTORY: 1985 EDITION INTRODUC1’ION ELIGIBILITY CRITERIA FOR INCLUSION OF CHEMICAL SUBSTANC ON THE INVENTORY REGULATORY ACTIViTY SINCE PUBLICATION OF THE INiTIAL INVENTORY • Testing of Chei , ir 1 Substances and Mixtures Under Section 4 • Premanufacture Notification Rule • Section 6(3) Orders/Section 5(0/6(a) Rules • Significant New Use Rules • Ru!. for Partial Updating of the TSCA Inventory Dets B . .. Production and Sit. R.porta • Limited Exemption from Premanufacture Review for Certain Polymer, • Limited Exemption from Premanufacture Review for Certain Low Volume USE OF THE INVENTORY • Element, of Identification • Description of the Inventory and • Using the Indices to T ixs’ea Chmiiua I Substanc. on the Invuntry INVENTORY SEARCH ASSISTANCE CHANGBS TO INVENTORY LISTING& CORREC’flONS DEIZI’IONS, AND CAB REGISTRY NUMBER UPDATE CHEMICAL SUBSTANCE IDENTITIES APPENDIX k Chamfr 1 Substance Definition. • SDA Substance Identification Procedure APPENDIX B: Confidential Chemical Substance Identities • Guidelines for Creating Prupca A Generic Names for Confidential u miui 1 Substance Identities for the ISCA Inventory ------- VOLUME II SUBSTANCE NAME INDEX USER GUIDE TO THE SUBSTANCE NAME INDEX SUBSTANCE NAME INDEX VOLUME III SUBSTANCE NAME INDEX USER GUIDE TO THE SUBSTANCE NAME INDEX SUBSTANCE NAME INDEX VOLUME 1V MOLECULAR FORMULA INDEX USER GUIDE TO THE MOLECULAR FORMULA INDEX MOLECULAR FORMULA INDEX VOLUME V UVCS INDEX, SECTION 4 RULE INDEX, SECTION 6(e) Ordur/SECTION 5 ( 1) 1 6 ( a) RULE INDEX AND SIONIP CANT NEW USE RULE INDEX USER GUIDE TO THE UVCB INDEX UVCB INDEX USER GUIDE TO THE SECTION 4 RULE INDEX SEC’lION 4 RULE INDEX USER GUIDE TO THE SECTION 5(e) ORDER/SECTION 5 (0/ 6 (a) RULE INDEX SECTION 5(e) ORDER/SECTION 6(0/6(a) RULE INDEX USER GUIDE TO THE SIGNIFICANT NEW RULE INDEX SIGNIFICANT NEW USE RULE INDEX ------- TSCA CHEMICAL SUBSTANCE INVENTORY: 1985 Edition The Toxic Substances Control Act (TSCA) Inventory lists over 63,000 chemical substances (as defined by TSCA) whose manufacture, importation, or processing for commercial purposes in the United States has taken place since January 1, 1975. The printed inventory is a 5—volume set containing TSCA Inventory substances listed by Chemical Abstract Service (CAS) Registry Numbers or Accession Numbers (Volume I). Indexes are provided for Substance Names (Volumes II & III), Molecular Formulae (Volume IV) and Substances of Unknown or Variable Composition, Complex Reaction Products and Biologicals, and Substances Subject to Regulatory Action (Volume V). Those who wish to purchase 5—volume sets should fill out the attached order form and mail it to: Superintendent of Documents, Washington, DC 20402. 9 P iltc t iEbq 1rgb3i, D C (372) 7 38 [ j Yes, please send ne _____ sets of the 5-volune TSC Inventory: 1985 Edition at $161.00 per set for the U.S. and Canada; and $201.25 for anycne outside of the U.S. or Canada. (S/N 055—000-00254—1) The total c t of iw order is $ _________ (P1 çe x st.) _______________________ PIA d k u tJt d of ( ) o & rktorthrt of Iboj uts. I] 1 r1.41t t. J I I I I I I 1—0 o v - -- - mIImujliIiiijIn __________ (Sig tr (aI r’, a d Zip ) ( eiLt Catd tate) ------- a SEARCH OF COMPLETE TSCA INVENTORY EPA .RegIon 0CM Received ER No. ____________ Priority Date ______________ _________________________________ Inspector Phone Number Certified Statement DYES ENO CAS No. - SPECIAL NOTE FOR DYES: At a minimum, you must provide a valid chemical name (not trade name) andfor chemical structure. Substance is not a Cotour index name D Substance is not a hydrate ___________________________________________________ . ChEMICAL NAME S I MOLECULAR FORMULA T _ STRUCTURE USE COMPANY NAME INVENTORY REFERENCE (Inventory Form No.) - ‘ . • — .. —— - IMD RESPONSE SECTION . ... - .•. • . . : _. Search completed on _________ ... Q-Noton Mory-- -- . Date placid Oi l Inventory invalid CAS number - - PMN I (if applicable) Valid CAS number Is not equIvsIe! ‘ Notice of commencement to submitted chemical ------- CERTIFIED STATEMENT I, Linda A. Travers, am Director of the Information Management Division in the Office of Toxic Substances. The Information Management Division is responsible for maintaining and updating the list of chemical substances compiled under Section 8(b) of the Toxic Substances Control Act (TSCA) known as the TSCA Chemical Substance Inventory (TSCA Inventory). I certify that the substance identified below has/has not completed the Agency’s Premanufacture Notice (PMN) review process and is/ but is not included in the TSCA Inventory as of the date specified. PMN Case Number: PMN Submitter: CAS Registry Number: ecific Chemical Name: Date PMN Received for Agency Review: Date PMN Review Period Expired: Date Substance Included on Inventory: Date Notice of Commencement Submitted to Agency: Date Notice of Commencement Received by Agency: as Linda A. Trav.rs, Director Information Management Division ass a4 Date ------- F ------- ,tD 3?4 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON. D.C. 20460 4 L J1j4 51989 orrlct or - PCS1ICIDCS AND TOXIC SUSSTANCCS MEMORANDUM SUBJECT: Enforcement Request (ER) Number 89-100 FROM: ,Joseph J. Merenda, Director 44 ” Existing Chemical Assessment TO: Michael Wood, Director Compliance Division (EN-342) This memorandum is in response to a request from Sherry Sterling of your staff. Ms. Sterling has requested a certification identifying chemicals involved in an enforcement action against Alcolac Inc. which may have been inadvertently included in the final Preliminary Assessment Information Rule (PAIR) published June 22, 1982 (47 FR 26992). Of the nine chemicals involved in the case, seven are in the category described above. The CAS numbers for those seven chemicals are: 96—05—9 105—16—8 818—61—1 868—77—9 2426—54—2 2867—47—2 3775—90—4 Please note that my staff believes one of the CAS numbers listed in the request was invalid. Our assumption is that CAS No. 868- 77—8 should be listed as 868—77—9. Following an in-depth review of OTS files and interviews with numerous current and past OTS staff, it has been determined that 53 chemicals were listed inadvertently on the June 1982 PAIR. I have attached a list of the chemicals highlighting (in green) those 53 chemicals inadvertently listed. I am requesting that 0CM not inspect nor take any enforcement action for violations of the final PAIR j such an inspection or action is limited to one or more of the inadvertently listed chemicals. In addition, I request that previous violations of the 1982 PAIR involving the 53 chemicals not be used in computing penalties for future TSCA violations. Please notify Bill Lee (382—3465) of my staff if you have any questions concerning this matter. Attachment cc: Sherry Sterling (EN—342) Rose Burgess (EN-342) Vincent Giordano (LE-134P) ------- iiunrivvricw AVAILJUM.E CN Rix:;i:iiw tO.’s vrs o • 7 —05--0 I r C I I JIi I t yl1e 11 . 3 aá 2—(c-—thyt—?- pfrT3yl) 122 _93_fl.l10” ihy) ciybLe etJ sJ. cLybte — - - n 4uty1 .icvylsste •I4l—32 fr c’ril in’s Iiych .. iP . 502—21—G’’ • et. Is.• ,I — 4— i i y tate b r’ p’ —y ti 2 ..iyht .1 ____________ - kcyl aciylate I __ I- J s ctiI ’i P.iyI ary1c te 2- i II.IrruII& l l suLFcniui 1 (2—hyILo- xyeLhyL) di.w thyl—, iwtIiyl ut(jLp• acrylate 2—(n t.hyLthio) ethyl acryIati ch.,L mc , c-liloride , iuutL(Iazo1e—4— crylate, rcnohydrothloricle (i(4- .,, L J9-5 4836—08—2 4836-09—3.’ 6032-P 2—2 ‘ S ivi’: or iiiro i ricii (IIr’LflI F’.frIc’rs, ____________ a n, cr rr ,pi ’.r l /&HL l #7E2 57$*kf3 jj E 1 .15 TEb 45 ‘ir. s, mm SI 4 .4 ?1I,Jc€.3 ” f: JM PAIR g14L( ZMY ..Ir *Je lI bf3,6.J4rEt (ekcevr oL 1 111.111 ‘\II • uji r )I ri)4 f — #W . — t r ( L I ------- I. llIIIl( Al. 1NU \ 2-ethyl l ity1 crylat. cliol irv?, l)icrate, ainLin.1l’—4—.ICLy late clolin.’, t -hydroxy — 5, 7—dinat .ro—2— n llitIiafrne sut(onate (salt), Imidazole — 4 — acryl ate choline, picrolonate (cdt), im1cIa old — 4 — acry late cliolLne, salt with 2,4, 6—tn nitroresorelnol (1:1), linldazole—4— acryl ate dioline, chloride, imidazole — 4 (or 5) — aciy late p ita y)a d .4. choline dj niijr e- tctrakli (&sothio-. cyanato) chronatc (I —), imidazole — 4 acrylate (ester) nenohydrate AS UnlcTny M).’s .39S)-10 1 4 6032-83—3 6032—84—4 ” 6032-85-S 6033-04-1 6209—43-4 10580-01— nLz iyt’r: c (IIFALTh EFFWIS, IXF JRE) Il7 C PCI i/pi j ii : •L1P l1—V -— — acrylate choline, iniclazole - 4 — acry late 70204-40—6 ------- (ii;’ I(’ I. n#vir rcnt.1i’th’,IiIasi(oxany1 - - - tert tutyl ‘ethacrylate ? ethyl iL - g1 CAS RIr.vrny tO’s 107-62—Q”” •$ J W4 — • 4$S—M—6 0 2351-42—0 •ZI5 —3$—S 2761—09-3 •a 67-47—3 2998—10—7 qJ7I-9 ,4 .5 7779—31— t .,••. p 3 —hyhcwb cJ )y1 r thacry1ate L L*L r ’ s 2C—tIuty1 ni ’thacrv1ate 3 S ,5-tr Iiw!thycyc diexyl t etJwrryIate - - ACRYUUIIn AU(YL r c I ethylene oxide propylene oxide I ____ .79—06—1 IYrE CF INFOIvWrIcw (IIFALm EP P•u ’ 1 , t CFCSJRE) W rrACr PEI oypHc ’ tI1%T Ial .d flLE 1 F ) triel.. ri thacrytate OT - -. t el • 75—21—8 .75—56-9 ------- (I.’ i .i r I,l.. I Ies i. —. 1i:i1 — I121TA— I •?. —Lz Ic.II I rh nz, iie I .2.4, - : i .1i’cjrtIx ,izene L.2.4- ri:’iloroL’-nzepe I— .IICrJL I. i fl I.?. LI—t tr. r Ii1o&cI,enzene 1.2. 3.S-t ”tiacIUo obenzena CAS P IS7HY •R7-GI—G .95-94—3 .100-70—3 20-B 2—i .608-93-5 .634-66-2 •63C -90-2 ‘(ttV T1( ti 7ULANJ: YFSf U ) TYPE OF I VtTfCV (I AL11I D’FLri , CanICT PELZ ., rr ’:Z CIIAYU:. ‘Iu flflW’ U24ES 1-c, :otcr. L .thatone U ir 1orc:i i’IitIil1e,’es i• ‘Ic rr— hthaIene I’_ i C r •i”iti ’.: lcnes ti ti :‘ ICt .)i “1ItII 1Cfle5 O (. h1o’ ’rLq tiIi ’ 1e’ies d ’..IilorOn tiUialcnes - t’; TI PAMFFINS r:. t’•res of C or 1c ger 1 .-7U ! rce, t b1orthe by aikanes with i.eight. I .90—13—1 •1321—65—9 •1321—64—B : : : 1 , .Iee’ t £ (j. :., .2234—13—i I .Cv •:‘: ‘ S 20699—88—9 J .74—07—3 . — $!U - ‘C C’L ’ •)LS o 1 r—c ero L CL ( “OI Th’Cd cctcrs’ • 108—94—i L,IcI1 Q ZIII .’ flC .75—09—2 1 .2-OJC)fl OR)P PNiE .78-87—5 ‘95—48—7 ‘108—39—4 ‘106—44—5 .1319—77—3 _,4, .4•( ------- 1NRJ{lf TiU1 DIPE or 1NIOI V TIaI AVMI4 DI E (IWJ LTh 1 T1 zS , :ic .i u CAS RIThSTRY P ).’a cYI m) ) ________________ O fl7CT lllflE • 106-50-3 Itj’X& UJ)PJN ?I]) Tr.rP1u24YI.s 12642-23—0 rv II)Iu •110—B6—1 4 1 4 1 ) 1 -i T 10 urr. .109—09—3 1 • 1 • 1-IR IOILOfOEThIINIE •11—55—6 o-K: lcne 9S-47- ni-xy lene • 100383 —.‘cyleno •106423 gTIi3cod ‘133 0207 ------- Existing Chemical Assessment Division Comprehensive Assessment Information Rule (CAIR) Using the authority provided in section 8(a) of the Toxic Substances Control Act (TSCA), the Existing Chemical Assessment Division gathers chemical-specific information from manufacturers, importers, and processors of chemical substances. ECAD has developed CAIR to make this effort more efficient and the collected information more useable. Anticipating the questions of potential users, the Division has prepared the following answers. What is CAIR? CAIR is a standardized, yet flexible, approach to gathering information on chemicals as they are defined under TSCA. It consolidates a comprehensive set of reporting provisions and questions into a model rule. Moreover, it provides a list of questions from which reporting requirements can be selected for various chemicals. Responses can be tailored to only those items of interest to data users. Who can use CAIR? The universe of potential users is broad. It indudes EPA and other Government offices needing information from industry to support risk identification, risk assessment, and regulation of chemical substances. It also includes other organizations that are involved in efforts related to health and/or the environment and that require information already available on a CAIR centralized data base. What are the advantages of a model rule? CAIR is designed to simplify and improve data-gathering procedures: As a model rule, it reduces duplication within the Government and saves the resources required to develop and implement chemical-specific rules. It also lowers industry’s reporting costs by decreasing the time needed to become familiar with separate rules for each chemical. In addition, CAIR is comprehensive in the kinds of information it can make available, as indicated below. What types of information can be gathered through CAIR? CAIR provides a mechanism to collect chemical-specific information on a wide range of subjects, including the following: • Identification and characterization of manufacturers, importers, and processors • Production volumes, trade names, and categories of uses • Chemical composition and physical/chemical properties • Environmental release and environmental fate • Market values, production costs, and availability of substitutes U.S. Environmental Protection Agency Office of Toxic Substances ------- Page 1 of 6 TSCA ABSTRACTS INVENTORY UPDATE RULE (IUR) (40 CFR Part 710] Effective Date: - August 25, 1986 Closing Date: December 23, 1986 Authority: Section 8(a) of TSCA Failure to comply is a violation of Section 15 of TSCA and will subject violatorS to penalties of TSCA Sections 16 and 17. Initial reporting period: most recent complete corporate fiscal year preceeding August 25, 1986. Recurring reporting: Eveiy 4 years for as long as the rule is in effect. Summary of Rule: Manufacturers and importers must report current data on production volume, plant site, and site-limited status (not distributed for commercial purposes as a substance or part of a mixture or article outside the plant site) for certain chemical substances included on the TSCA Chemical Substances Inventory. WHO MUST REPORT (Section 710.28]: A person is subject to this rule if he has manufactured or imported a reportable substance in the United States at any time during the most recent complete corporate fiscal year prior to August 25, 1986. (See EXEMPTIONS . page 4.) REPORT FORM [ SectIon 710.39 (d)j: Partial Updating of TSCA Inventory Database Production and Site Reporr Form U (EPA Form 7740-8). REPORTING VOLUME LIMITS : A chemical is subject to reporting if production (manufactured or imported) is more than 10,000 lbs (4,540 kg) at one site. Low- volume substances with an annual site-specific priduction volume (or total amount imported) of less than 10,000 lbs are excluded from this rule. ------- Page 2 of 6 REPORTABLE SUBSTANCES (Section 710.25]: Those that were initially reported for the TSCA Chemical Substances Inventory, as well as substances added to the Inventory following TSCA Section 5(a) PMN review and the Agency’s receipt of an NOC of manufacture or import. (See EXCLUSIONS , page 3.) INFORMATION TO BE REPORTED (Section 710.32]: Chemical identity, pIa t site, annual production volume, and site-limited status. Also required is name, address, and telephone number of technical contact. Chemical IdentIty: Chemical name (not trade name) and CAS Number. For confidential substances with no CAS Number, an EPA- designated Accession Number should be provided instead. If submitter cannot identity a particular substance by CAS Number or Assession Number, then PMN number, original Inventory Reporting Form Number, Bona Fide DCN, or TMEA number may be used. Plant site: Specific plant site name and address. Corporate HO, business, or POB addresses are not acceptable. Submitter must also provide a D&B Number for each reporting site. Production Volume: Quantities must be reported in pounds. Quantities must be accurate to the extent that the information is known or reasonably ascertainable by the submitter, or two significant figures ( 10%). Importers may report volume by plant site or as the total quantity imported by the company. Sits-limited Status: Whether substance is distributed for commercial purposes outside the site. Imports are not site-limited. RECORDKEEPING (Section 710.37]: Reporters are required to maintain records that support the information in the submission. Records must be kept for 4 years beginning with the effective date of each reporting period. ------- Page 3 of 6 Records required include those that show the production volume, plant site, and site-limited status of each of the substances reported. If a substance is not reported because its site-specific annual production is less than 101000 lbs., volume records must be maintained as evidence to support a decision not to submit a report. Persons who are exempt as small manufacturers are not required to keep records. DUPLICATIVE REPORTING (Section 710.35]: Any person who has submitted a report under a Section 8(a) rule within 1 year of the start of the reporting period (i.e. August 25, 1985 - August 25, 1986), is not required to report again on the manufacture of that substance at that site. When two or more persons are involved in a particular import transaction, only one of them needs to submit a report. If no report is submitted, each is liable for failure to report. EXCLUSIONS (Section 710.261: Excluded from the reporting and record- keeping requirements of this rule are the following: POLYMERS. INORGANICS. MICROORGANISMS . and NATURALLY OCCURRING CHEMICAL SUB- STANCES . Many substances excluded from the rule are labeled with a special NXUN flag in the 1985 edition of the Inventory. However, substances other than those labeled with the XU flag may also be excluded from the rule. Polymers may be identified by the presence of polym, alkyd,’ or oxylated in the CAS Index or Preferred Nomenclature. Polymers may also include siloxanes and silicones, silsesquioxanes, proteins, enzymes, polysaccarides, rubber, or lignin. Inorganics do not contain a carbon atom, or contain carbon only in the form of carbonato (.C0 3 J, cyano (-CNJ, isocyano (-NC], cyanato (-OCNJ, or isocyanato (-NCO] groups, or the chalcogen analogues of these groups. Microorqanisms are bacteria, fungi, yeasts, and eimeria. Calcogen - see page 610, definitIon. ------- Page 4 of 6 Naturally occurring chemical substances are chemical substances which are naturally occurring and which are unprocessed or processed only by manual, mechanical, or gravitational means, or by dissolution, flotation, or heating solely to remove water [ 40 CFR Section 710.4]. EXEMPTIONS 1. Small Manufacturers (Section 710.29 and TSCA Section 8(a) Small Manufacturer Exemption Rule (40 CFR 704.5(d)]. Small manufacturers must meet one of two standards: (1) Total annual sales, when combined with those of its parent company, are less than $40 million. However, if annual production volume of the chemical substance subject to reporting is more than 100,000 lbs (45,400 kg) at a site, the manufacturer must report production for that site. (2) Total annual sales, when combined with those of its parent company, are less than $4 million, regardless of the quantity of chemicals produced by that manufacturer. 2. Limited manufacture (Section 710.301. Persons who manufacture or import substances in small quantities for R & D or persons who import substances as part of articles, are exempt from reporting. Persons who manufacture substances as impurities, byproducts, etc., as described under 40 CFR Section 720.30(g) and (h) of PMN Rule, are also exempt. EXCEPTIONS TO EXCLUSIONS AND EXEMPTIONS If a polymer, inorganic substance, or microorganism is the subject of a TSCA Section 5(e) or 5(1) order, or is the subject of a proposed or promulgated TSCA Section 4 test rule or TSCA Section 5(a)(2), 5(b)(4), or 6 rule, or is the subject of relief granted under a civil action under TSCA Section 5 or 7, that substance Is not excluded from the rule. ------- Page 5 of 6 Section 5(a)(2) refers to the Significant New Use Rule (SNUR). Section 5(b)(4) refers to the Administrators list of chemical substances which present or may present an unreasonable risk of injury to health or environment if manufactured, processed, distributed in commerce, used, or disposed of. Section 6 refers to rules prohibiting or limiting manufacture, processing, dis- tribution in commerce, use, or disposal of chemical substances which present an unreasonable risk of injury to health or the environment. OCM’s onontv order for IUR violations : 1. Failure to report Level I Violation 2. False reporting Level 1 Violation 3. Circumvention of Section 5 PMN Violation/False Report reporting 4. Late reporting Level 4 Violation 5. Error letters (No response, Level 6 Violations late response) DOCUMENTATION 1. Document total annual sales and/or production volumes >10,000 pounds/plant site for total annual sales >40 million dollars, or >1 00,000 pounds/plant site for sales of $4-40 million 2. Document the corporate fiscal year 3. Document that commercial manufacture/importation occurred 4. Document claims for exemptions or exclusions. Check chemical records against CORR list, to ensure that there are no reporting rules for a chemical for which an exemption or exclusion is claimed. Note that IMO will determiner whether the substance falls within the Part 710.26 exclusions. ------- Page 6 of 6 If an exclusion violation is documented during an inspection, complete a “Search of Complete TSCA Inventory” form Immediately upon return to NEIC and have it submitted to MD with a request for a Certified Statement, Partial Updating of the Inventory DataBase Rule Search and Status. NOTE: The Inventory Update Rule [ 40 CFR Part 710] uses the term “calcogen analog” in the section excluding inorganic chemicals from IUR reporting (Section 710.26J. According to Hack’s Chemical Dictionary, “calcogen’ is used in the same context as “halogen,” and refers to the elements oxygen, sulfur. selenium, tellurium, and polonium. From the standpoint of excluded chemicals, take this to mean that “inorganic chemicals do not contain a carbon atom, or contain carbon only in the form of carbonato [ =C0 3 ], cyano (CN], isocyano (-Nd, cyanato [ -)CN], or isocyanato (-NCOI groups, or analogs in which the oxygen is replaced by sulfur or possibly selenium.N The most likely analogs would be thiocyanato [ -SCN) and isothiocyanato [ -SNC]. ------- G ------- Existing Chemical Assessment Division TSCA Section 8(c) Allegations of Significant Adverse Reactions What is Section 8(c)? Section 8(c) of the Toxic Substances Control Act (TSCA) requires manufacturers and processors of chemical substances and mixtures to maintain records of allegations of adverse effects to human health or the environment believed to have been caused by the chemical substances or mixtures. Any person may make such art allegation. including an employee, a private citizen, a plant neighbor, or another company representative on behalf of its employees. While the allegation need not be supported by scientific or medical evidence, for the purposes of 8(c). it must establish a link between a chemical substance or mixture, a particular company’s product. process, or effluent, and any “significant adverse reaction” experienced by the public or environment. Manufacturers and processors are required to collect, record, file, and retain these allegations. What purpose does 8(c) serve? Section 8(c) of TSCA requires that a worker or consumer allegation be recognized and retained by industry. EPA expects that individual companies will use the 8(c) records to identify problems associated with the chemi als that they manufacture, and will subsequently take steps toward resolving identified problems. This section also serves to create a historical record of significant adverse reactions alleged to have been caused by a chemical substance, mixture, process, or effluent. It thus provides a means to identify previously unknown chemical hazards and to reveal patterns of adverse effects that might otherwise either go unnoticed or go undetected for long periods of time. What are the 8(c) major provisions? The final rule implementing Section 8(c) of the Toxic Substances Control Act was promulgated on August 22, 1983 and became effective on November 21, 1983. (See 40 CFR Part 717.) Industries must keep allegations of adverse health effects filed by employees for 30 years. and keep all other allegations for 5 years. Both written and oral allegations must be retained. EPA may inspect these records and require submi sion of copies. Who can use 8(c)? ECAD can requite industry to submit 8(c) records on specific chemical substances at the request of EPA program offices and other government agencies. In addition, other organizations may request already available 8(c) information from a central file. For further information regarding TSCA Section 8(c), please contact: TSCA Assistance Office, TS-799 U.S. Environmental Protection Agency 401 M Street, SW Washington, DC 20460 Telephone: (202) 554-1404 A videotape ia also available on TSCA Section 8(c) and can be obtained by calling the above number. U.S. Environmental Protection Agency Office of Toxic Substances 9/88 ------- FACT SHEET Final TSCA Section (c) Pule Records and Reports of Allegations That Chemical Substances Cause Significant Adverse Reactions tO Health or the Environment. Background o Section 8(c) of the To*ic Substances Control Act (TSCA) requires that any person who manufactures, processes, or distributes in commerce any chemical substance or mixture’ must keep ‘records of significant adverse reactions to health or the environment, as determined by the Administrator by rule, alleged to have been caused by the substance or mixture. o Section 8(c) requires that allegations of adverse reactions t Q the health of employees be kept for 3O ears , arid all othe? alTegati orts be kept for five years . o EPA may inspect these records and require submission of copies of such records. Purpose - o The rule defines ‘significant adverse reacttons to chemical substances and mixtures and estaolishes a system of recordkeeping and reporting. o The rule creates an historical record of significant adverse reactions alleged to have been caused by a substance or ‘nixture. EPA can examine such records whenever a chemical is discovered to present possible risks to human health or the envi ronisent. o Also, th. rule provides a means to identify previously unknown cheiBical hazards and to reveal patterns of adverse effects that might otherwise either not be noticed or go undetected for long periods of time. ? fistory o EPA proposed a rule to implement section 8(c) of TSCA. which was published in the Federal Register of July 11, 1980 (45 FR 47008). o Approximately leo written c3mrnents were received on the proposal and public meetings were held in Washington, D.C., Newark, N.J., and Houston, Texas. ------- o Allegations subject to the rule — 30th written, signed allegations and oral allegations are sub3ect to the rule. (A company is not required to record anonymous allegations.) Oral. allegations must be dealt with i one of two ways. The company can either transcribe the oral allegation itself or it can request that the alleger submit the allegation in written form and sign it. — Allegations nay be made by any person, such as an employee, a consumer, a plant neighbor, another firm on behalf of its employees or an organization on behalf of its members. — An alLegation can cite one of several causes of a reaction including a specific chemical, a mixture, an article containing a substance, a company process or operation, or an effluent or other plant site emission. o Recordkeeping Requirements — Records must be kept for 30 years In the case of allegations involving the health of employees: (even if it is not the company’s own employee). All other allegations (i.e. consumer, plant neighbor, etc.) must - be kept for five years. — Records must be kept at the company’s headquarters or at a site central to their chemical operations. Records must be retrievable by the cause of the reaction. — The record must include the original allegation as received, an abstract of specific information in the allegation (see S717.15(b)(2) for specifics), the results of any self—initiated investigation, and copies of any further required records or reports (i.e. to 0 HA or CPSC) relating to the allegation. o rnspection Reporting/Conf identiality EPA can inspect these records and require reporting. When reporting is required, firn s will be notified y letter or by notice in the Federal Register and will have no less than 45 days to respond. Fir ts nay claim all or part of such submissions confidential in accordance with 40 CFR Part 2. exemptions o Persons not sub]ect to the rule — Firms or sites solely engaged in mining or other solely extractive functions are exempt from this rule. ------- Fact Sheet - TSCA Section 8(c) Rule Amendments Background • The rule implementing section 8(c) of the ToxiC Substances Control Act (TSCA) was promuL jated on August 22, 1983 and became effective Uovember 21, 1983. The rule requires manufacturers and certain processors of chemical substances to keep records of significant adverse reactions to human health or the environment alleged to have been caused by chemical substances and mixtures. 0 After promuljation of the rule, the Agency received numerous questions, many of which involved uncertainties about who is subject to the rule. Pu r poses • The basic purpose of these proposed amendments is to clarify who is subject to the rule. Major Provisions ° One amendment adds an exemption for ucoincidental inanufacturers . This provisLon states that coincidental manufacture of chemical substances is not an act that, by itself, makes a person subject to the rule. This amendment parallels exemptions in the TSCA Irtve tory regulations as well as the final Premanufacture Notification (PMN) Rule. • Another amendment clarifies what processors are subject to the rule. The original rule language used Standard Industrial Classification (SIC) codes 28 and 2911. as descriptors of those processors sub]ect. The amendment simply states that processors who are not also manufacturers are subject If they produce mixtures or repackage chemical subs tances. o The preamble of the rule also answer other questions about the 3(c) rule that were raised by commenters. Additional Information Copies of the amendments to the TSCA Section 8(c) rule are available from the TSCA Assistance Office (TS—799), Room E—543, East Tower, 40 ]. 4 Street, S.W., Washington, D.C. 20460, or by caLling (202) 554—1404 (in Washinyton, D.C.) or toll—free 800— 424—9065 (outside Washington, D.C.). Persons with questions also may call the above numbers. ------- c:tiUn 1 r ‘ 11 w Section (c) of P i T)ziC Substances Control Act (TSC ) requires all persons who manufacture, process or distribute any chemical substances or ‘fixtures in commerce to keep Such records as the Administrator iay require by rule concern1n allegar.lons of signif ican: adverse reactions to health or :!le environment associated witri SuCh substances or mi*tures. E published the ISCA section d(c) rule in the Federal Register on Auyust 22, 1983 (48 FR 3d 7d). The rule beca’ e effective on ovember fl, 19d3. The purpose of TSCA section 8(c) is to establish a record of allegations of significant adverse reactions to human healtn or the environment. Such records nay reveal patterns of adverse effects which may be the first indication of the existence of a serious problem meriting further Agency attention. The rule i nplement ing TSCA section 8(c) describes the types of allegations t be kept. Trlis.document contains the strategy for monitoring compliance •.‘th the section 8(c) rec r ee?ing and reporting requirements. It discusses the regulation requirements, violations, compliance r’onitorln; activities and the allocation of responsibilities between I1ead uarters and trie Regions. Pe .nrements of tne egula:io’i Persons Subject to the ule AH ianufacturers of chemical substances are subject to this rule. If manufacture occurs at any site owned or controlled by a firm, then that firm Is subject to tne rule. Addi:ionally, perso.is whO process chemical substances are subject to the rjle if their processor activities are described in Standard Industrial Classi• ficatlon (SIC) Major Group 29, Chemicals aiid Allied Products, or SIC Code 2911, Petroleum Refining. The Agency estimates that 10,000 persons are subject to the rule. Persons Iot Subject to NQ Rule Persons whose manufacturing activities consist of mining or other solely extractive functions are exempt from the rule. This exemption may include but is not limited to firms engaged in activities described in SIC Division 9. Mining, and SIC code 2813, Industrial Gases. A processor whO is not also a manufac- ------- — - r 15 PJt 5 ahJeCt i : rile if ,f jrO c. jr ‘ ,: 1, e1gacJ (I ifl dCt1vii . S U.:scrii)e’J in SIC 2 • r s : ; Aiierson who is s leli n1Stri utor f.i c ie’ ic l s’ t3t::e 13 exempt from the ii5 exemption r ay incl e ersu s activities ar describe’j in the wnolesale trace SIC codes l6l Chemicals and Allied ?roduct$, 5171 - Petroleum 3uHc Stations and Terminals, an l72 - ?etroleum and Petroleum Products wholesalers, Except Bul Stations ar Terminals. T.iis ooes flop., however, include distriOu: rs who also repackage chemicals or mixtures. Such persons are processors. Finally, a person whO’s a retailer 0? a chemical substance is exempt from tnis rule unless SuCh person is also a manufacturer or processor whO 15 s .jec: to the rule. Allegations Subject to this Rule Persons subject to this rule must record all allegations of health and environmental effects, as described in trie rule, that are received on or after NovemDer 21, 1983. Allegations may e s i itted in writing or iiade orally. If they are made orally, the company may either transcribe the alle- gation or inform the alleger that the allegation may be subject to this rule and suggest tnat the alleger submit tne allegation in writing and sign it. (.f the alleger does not put an oral 1l gation, such as a telephone call, in writing after a company reque1 to do so, then tne co.ii any does not have to record the allegation. An allegation whici is su je:t to he rule is or whici implicates a chemical in an adverse reaction in one of the following ways: o NamIng the specific substance. o Naming a mixture which contains a specific substance. o NamIng an article that contains a specific substance. o NamIng a company process or operation in which a specific substance is involved. o NamIng an effluent, emission or other discharge from activities subject to the rule. Allegations may be made to a firm by any person, such as an employee of the firm, a consumer, a plant neighbor, another firm on behalf of its employees or an organization on behalf of its members. EPA encourages firms to provide allegers with intormatiofl regardini tne ultimate disposition of their allegations. The types of allegations which the manufacturer or processor must record include tnose involving the following human healti ef ------- —3— .Oti9—IdStin j “ , rSi)IL’ U ’.ia,.’ , s.: ’ s ..itI:cr birth defect. o Partial or co.’ 1 :: i,i airnIenc of o ui1 1 f.inctin , SUCh as reproø. ::iv ilSOrders, neurolo icaI d1s r r , or blood disoroars. o An impairment f ur ial activities e*perienced y all r most of the persons e*posed at one ti.i . o An inpair nent jf nor,,al activities wri1C’ is exper1e each time an individual is exposed. nown hu:nan h lt effects as defined in 7l7.3(c) need not be recorded. Ecological effects wP,lch must be recorded include: o Gradual or sudden changes in the composition of animal 1if or pla’ t life, including fungal or iicrobtal organisms, in an area. o A or ial nu . er of deatns of organisms (e.g.. fish kills). o Reduction of t e reproductive success or the vigor of a specs es. o Reduction ii a;ricjlt ral productivity, whether crops or livestock. o Alterations in the behavior or distribution of a species. o Long lasting or irreversible contamination of components of the physical environment, especially in the case of ground water, arid surface water and soil resources that have limited self—cleansing capability. Ecological effects which are restricted to the vicinity of the plant site must be recorded, but effects which are the results of spills or other discharges reported to the federal government need not be recorded. How and Where to Keep Records Persons subject to this rule must establish and maintain records at the firm’s headquarters or at any other appropriate location central to the firm’s chemical operations. The record of an allegation snall consist of tne following information: o The original allegation as received (see “Allegations Subject tO the Rjle’ on page 2). o An abstract of trie allegation and other pertinent information as follows: ------- • 7i ,. flu.IC dfl — ; r th ! i: si : —, the d l le Jati — The date the : W3S r c ive j ut tn t - The i iiplicatej s stance, mixture, article, company process or Oper3tIOn, or site discharge. - A description he lle er e.g., coriipan employee,” °individual cD su -’er , ” plant nei Pibor’). f tr e allegation involves a healtn effect, the sex and year of birth of the affected individual Should be recorded, if ascertainable. — A description of the alleged health effect(s). The description riust relate how the effect(s) became known and the f3ute Of exposure, if explained in the a) 1 egation - A description f the natire of the alleged elvironmentel effect(s), identifying the affected plant and/or animal species, or contaiinated portion of the physical environment. o The results of a y self-initiated investigation with respect to an allegation. does not req, ire persons SuDJC: : t this rule to investigate allegations received.) o Copils of any fjrt. ’ er required records or reports relating to the alle;atioi. F r exa iple, if an e”iployee a1le a:i:i results In a requirement for the firm to record t e case on Occupational Safety and ealth Form 101 or appropriate substitute (see 29 CFR Part 1904 for requirements under the Occupational Safety and Health Act of 1910), a copy of that OSIIA record must be included in the allegation record. Records must be retrievable by the alleged cause of tne adverse reaction including the following: o A specific chemical identity. o A mixture. o•An article. o A company process or operation. o A site emission, effluent or other discharge. Allegations related t: y e Pieal : i of employee’ ------- .ir made hy •‘i ‘us: fur th1r i ,r. —— ii IcmJ.3tIOflS ‘lust b ¼ or five years . If a i Si”C S, itS SUCceSSJr lust rec n,e dflJ ‘maintain the rc jr:S r.h.2re is no successor cse records “lust traiisulitterI ) Companies must ‘nail the records to: Document Contr3l Officer Office of ?estlcines and roxic Substances (TS-793? Environmental Dr,,tection Agency Washington, D. C. 2’J360 Inspection and Qeporti g I Records subject to this rule must be made available for inspection by any duly desiynated representative of the Ad T%i fl I stra tor. The Administrator may require that any person subject t tnis rule Submit copies of records. Notif cation of the require- ment to report may be made by letter or Federal Register Notice. The notification w ifl specify a reporting period wn lch wifl be at least 45 days Persons required to report under the rule will submit copies of the required records to: Document Control Officer Office of ?est lc ldes and Toxic Substances (15—793) EnvIronmental ?rotectlon Agency Washington, D.C. 20460 Persons submitting records may claim that the records are confidential business information by following the rocedjres described in §717.18. ------- H ------- TSCA C8(d) ILrH . NU AP TY DATA RI PORTt C I i;LE t. TSCA Section 4W) AuehorLty. AdI LnLracor aiiaL requi.re any por r)n WflQ anuf tures, rc’ci sscs, or dt trLnutc , a suestance or rnLxture in commerece (or who rcpo os eo do so) and whc ha possession of a study, to 9unOLt copy of. thAt tudy to thu A c’ncy. ‘ersons chal.l sur v’tt ti t.s c)f itudie Conriuceed or irutiated y or for ch persons. tI. ackground. A. TSCA ‘ (d) ueaLtn and Saf ity rule was designed to provide unpu ’tished health and safety studies for invesci attor s of rhe risk posed by chemcial*, and, n particular, en support its decisions whether to require Lndustry to test chemical, under section 4 of rsCA. 8. Cenertc rule in CFk. 1. w .ii amend rule with eacr addition of chemicaLs. (to o t cases the char&cats that are addec 4 to v.e 8(i) rule are al added to the Level A rule.) 2. The sai c (d) reporting requtrements apply tor each cner’ical added r.o t e rule. !U. Status. A. 1978 finaL rule publishel; EPA sued y DOW over certain authorities invoked in rule. Court upholds EPA. C. PA re—prcposed rule in L 79; final rule puriliihed ‘,n Septeiber 2. 19a2. I). ive subsuquent jnondi’ents . Pucri acirteti c.t cmLcaLs to the rule. (The tatest-—Decemher 14, 1983.) IV., Persons Required to Report. A. anufacturero anil )rnceseors whO ruanufacturi d or processel a suoject cher’ical, or propusod to d ao. durtnj tn tcn— ,r ,erLnI prior to tue effective date of thi rule. B. OistrLOue3r ar o*empt. C. Persons (otr.er than a manufacturer or procsSsor who are listed as posieistnij i tudy’wiL1, ne asked to submit tr o study vrilunt3rtly. ------- ------- Existing Chemical Assessment Division Section 8(e) of the Toxic Substances Control Act An Overview Section 8(e) of the Toxic Substances Control Act (TSCA) states that “any person who manufactures, [ im- portsl, processes. or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment shall immediately inform the [ EPAI Administrator of such information unless such person has actual knowledge that the Administrator has been adequately informed of such information.’ Section 8(e) became effective on January 1, 1977, the effective date of TSCA. A Section 8(e) policy statement (“Statement of Interpretation and Enforcement Policy; Notification of Substantial Risk”), which clarified the types of information to be submitted and the procedures for doing so. was published in the Federal Reg:ste’r on March 16, 1978 (43 FR 11110). Since January 1. 1977, a large number of Section 8(e) notices covering a wide range of chemical toxicity/ex- posure information have been received and given priority evaluation and appropriate followup attention by the Office of Toxic Substances (OTS). Upon receipt of a Section 8(e) submission. OTS prepares a status report which contains a description and preliminary assessment of the submitted information, a statement regarding production and use(s) of the sub- ject chemical(s), and recommendations for appropriate OTS followup actions/activities. EPAs implementation of Section 8(e) has brought about heightened corporate awareness of potential chemical risks, leading to voluntary company actions designed to protect human health and the environment. Many companies have reported that in direct response to submitted chemical toxicity/exposure information. the following types of health and environmental protection measures were initiated: • Notification of workers, customers, and others • Labeling and Material Safety Data Sheet (MSDS) changes • Manufacturing, processing, and/or handling changes • Chemical production or use halted temporarily or discontinued altogether • Additional toxicity/exposure studies performed. The chemical industry’s increased awareness of potential risks posed by chemicals to health and the environ- ment is evidenced further by many voluntary industry submissions received by OTS on a “For Your Informa- tion” (FYI) basis. High-level scientific and administrative contacts have been established by O’I’S in each of EPA’s Program Offices and in other Federal agencies (e.g., NIOSH, OSHA, CPSC, FDA, NTP) in order to provide a mechanism for timely and prioritized dissemination of information concerning newly discovered hazards/risks associated with exposure to chemical substances or mixtures. The information is also made available to all interested per- sons via the OTS public files. For further information regarding TSCA Section 8(e), please call: David R. Williams (TS-778) TSCA Section 8(e) Coordinator Office of Toxic Substances U.S. Environmental Protection Agency 401 M Street. SW Washington, DC 20460 Telephone: (202) 382-3468 U.S. Environmental Protection Agency Office of Toxic Substances 9/88 ------- E(N) Existing Chemical Assessment Division “For Your Information” (FYI) Submissions An Overview The For Your Information” (FYI) submission classification system was established by EPA’s Office of Toxic Substances (OTS) to distinguish such submissions from “substantial risk” notices submitted formally to EPA under Section 8(e), a mandatory reporting provision of the Toxic Substances Control Act (TSCA). Since 1977, 01’S has received FYI submissions covering a wide variety of chemical substances and mixtures from chemical companies, trade associations, unions, public interest groups, civic associations, private citizens. academic institutions, State and other Federal agencies, as well as similar organizations/agencies in foreign countries. These notices contain information on human exposure, epidemiology toxicity test results, monitoring studies, environmental fate, and other information that may be pertinent to risk assessment. All FYI submissions that enter the 01’S FYI document process are reviewed and evaluated in a timely manner as part of the chemical “screening” process within the OTS Existing Chemicals Program (ECP). In recent years, the FYI reporting mechanism has been used by 015 to solicit voluntary submissions of unpublished chemical toxicity and exposure data for preparation of “Chemical Hazard Information Profiles” (CHIPs). Many FYI submissions contain negative or equivocal findings that the submitting organizations wish to share with EPA. 01’S also receives FYI notices containing positive data of the type required for submission to EPA under Section 8(e) of TSCA. The submission of positive data to EPA on an FYI basis usually occurs because the submitting organization does not have a TSCA reporting obligation or does not believe that the data are reportable under Section 8(e) of TSCA. In such cases, the CT’S review of the data may result in an EPA determination that the submitted information should have been reported formally to EPA under TSCA Section 8(e). Such a determination on the part of EPA results in a referral to EPA’s Office of Compliance Monitoring’ (0CM) for action(s) in accordance with the Agency’s TSCA Sections 8, 12, and 13 Enforcement Response Policy (ERP). The evaluation of and appropriate followup attention given to FYI submissions by 01’S helps in bringing about heightened awareness of the potential hazards/risks posed by chemicals, often leading to voluntary actions designed to protect human health and the environment. Many of the organizations providing information to EPA on an FYI basis have reported that they have initiated the following types of health and environmental protection measures: • Notification of workers, customers, and others • Product labeling and/or Material Safety Data Sheet changes • Manufacturing, processing, and/or chemical handling changes • Manufacture or use halted temporarily or discontinued • Additional toxicity or exposure studies conducted. High-level scientific and administrative contacts in each of EPA’S Program Offices and in other Federal agencies (e.g., NIOSH, OSHA, CPSC, FDA, NTP) are maintained by 01’S in order to provide a mechanism for timely dissemination of information regarding newly discovered hazards/risks associated with chemical substances or mixtures. The information is also available to interested persons via the OTS public files. For further information regarding FYI submissions, please contact: Jacqueline Favilla (TS-778) FYI Coordinator Office of Toxic Substances, U.S. Environmental Protection Agency 401 M Street, SW Washington, DC 20460 Telephone: (202) 475-8823 U.S. Environmental Protection Agency Office of Toxic Substances 9/88 ------- FYI Procøssina IND: Information Management DivusioniOTS CRIS: Chemical Risk Identification Sectuon/CSB HERD: Heaith & Environmental Review DivusuoneOTS EED: Exposure Evaluation Division DCO Document Control Off uce/IMD Jacqueline Favulla FYI CoordinatoriCRlS/CSB Telephone: (202) 475-8823 FTS: 475-8823 James F. Davr Section HeadFCRIS/CSB Telephone: (202) 382-3470 FTS: 382-3470 Frank D. Kover Branch Chief/CSB Telephone: (202) 382-3436 FTS: 382-3436 IMD I I I I U I I U U U I U U U U U U U . I • U • I • I Acronyms: ------- çTXOa I Ce) 0? TU TOXIC SUU?MICU U ?1OL ACT TSCA) All OVUVUW • Section 5(e) at the Toxic Substances Control Act (TSC*) states that ‘any person whi •anutactures. processes. or dtitibqt,s in .rve a chs.ica.L substance or aixture and who obtains infoceation which reasOnably supports the conclusion that such substance or Stature l 5iOti a 5Ub stantia.L risk of injury to health or the •n.tgo nt shall tsdiately 1nfo A. Lnistrater of such Infot itiOl1 muss such person has actual knovl.dge that the Adoint strator has been d.quat.ly totoceed of such infognatton.’ • S.ction SC.) bec •ff.etiws on January 1, 1577, the effective date of TSCA. • A Section I(s) policy statsoent (‘$tat.ftt of !nterprst$— ties and tnforvsnt Policy, Notification at Substant aL Risk’) vhich clarified the types of infoceation to be subsitted and the procedures for doing 50 vii published in the ?sdsral Register on March lI. 1575 (43 Pa 11110). • Since January 1. 19 ”. over 550 Section SC.) notices covering a wide rang, of cheatcal texicity/suposur. infomatieft isv. been received and given Priority evaluation and appropriate fallow—up attention by the Office of Toxic Substances (OTS). • A status r.port is prepared which contains a description of the suhsittsd infoonatien. the OTI preliainasy assess- oust, a statseent regarding production and iRe(s) of th• subject chsstcsl( 5) • and rec .ndat tone for appropriate OTS follow—up actions/activities. • taplesentation of Section ICe) has brought about heightened top—level corporate awareness of potential chssica3. hazards/risks Leading to v..Lwisaiy conpany actions designed to protect hian health and the enviroseent. • Many conpantes have reported that in direct respons. to smibaittsd chsoical toxicity/exposure inforeation. the following types of health and envirsse.ntal protection .eaaures wore initiatedi • Notification of workers. cuitseers, and others • £.ah.lling and Material Salsey Data Sheet (550$) changes • nanufacturing, processing, and/er handling enanges • Che.ical application/use discontinued • Additional toxicity/exposure studies perfessed C ics1 production haltsd/discontinuid • The chtcal. industry’ s Increased awareness of potential hasaFds/etsks posed Dy chicals to health and/or the enwizoseese is further evidenced y over 400 voluntary industry suonissions received by OT$ on a ‘Par tour Info ation (PT!)’ basis. • Nigh level scientific and tnistrative contacts have been established by OTS In each of DA’s Progras Offices and in other ?sdersl agencies (e.g.. MZO1I. 035*. CPSC. FDA. MC !. etc.) in order to provid, a uschanlm for tinely and prioritized dissination of Infosustion concerning newly dis ersd haxards/risks associated with exposur, to cflseicsL s tances or •iztufls. ------- 1. Ovcr ’:ic.i Section C(e), a self-i .p1crn2n?inr provision of the Toxic Sub;ta ’ccs Control t (i C ) went i.itu effect on Januery I, l 77. On arch 18, 1 8, the nviron ,:enta Protection Agency (EPA) pubhshed a “Statement, of triterpre- t tion and Enfor:erieit c1ic ’ .,ti lch reflects the Agency’s current posh ori rcgardin the reluirements for cori lia,ice with §8(e). The major o ject1ve of §3(e) aid the “Policy Statement’ i to ensure that in ’jrration which reasonab’y supports a onCiu;ioi that s st ia risk is sscciaLed :ith a chcini:al suhs a”ce or s ro’ ght to ErA’s attc’i:1 n i;!%r:tcdiately upo’i discovery rather than upon request by th A ;cncy. t.lthough recei t of ‘s bs n ia1 risk ” infor ticn by thc Agency does not necessarily tr gger iinmedi te regui- tory control, it nay indicate the need for further evaluation which may serve as the basis f r future control. The ohjective of the “Policy Staterne t’ is to facilitate compliance with §8(e) by (a) clarifying what constitites subctantial rts infor- mation, (b) specifjing infor a: ion exempt frori the repor’.ir ; requirei.ie1 , and by (c) outlining reporting procedurcS. ------- -2— This document contains the strategy of tfle Office of Enforcement (OE) for enforcing ç3(e). It discusses the stat- tory requirements as interpreted by the “Policy Statement,’ violations, priority compliance monitoring activities for FY 81, and aflocation of responsibilities between Ieadquarter arid the Regions. II. Recuirements of the Rule TSCA §8(e) requires that “any person who martu- factures, processes, or distributes in commerce a chemical substance or mixture and who obtains information wniCh reasonably supports the conclu- sion that such substance or mixture presents a substantial ris of ln3ury to health or the envi- ronment shall imriediately inform the Administrator of such inforriation, unless [ tne) person has actual knowledge that the Ad n1n1strator has been adequately Informed of t e information.” No formal rflemaking was required for implementation of the provisions of §8(e), which went into effect on January 1, 1977. On September 9, 1977, however, EPA’s Office of T x1 Substances (OTS) published proposed guidance (42 F 45362) to explain Agency policy regarding §8(e) reporting requirements arid procedures. After considering public comments on the proposed guidance, EPA published a “State- ment of Interpretation and Enforcement PoHcy ” on March 6, 1978 (43 FR liflO) (hereinafter referred to as the ‘Policy Statement”) which reflects the Agency’s current position regarding the requirements of §8(e). The Agency is currently codifying the Policy Statement. ------- Any huS1nC S entity an. any of its employees wh are capable of appreciatin; :. e significance of iriformatic.’ , concerning a Substant i 1 risk associated with a cheriical substance or m-ixture ranufactured, processed, or diStributOd by the entity must report :nis information to EPA. In the case of business entites, the president, chief executive officer, and any other officers responsible and having authority for the orgaiiz3tlon’s execution of its §8(e) obligations nuSt ensure that the organization reports sub. stantial risk inforrna:i n to EPA. All employees with the exception of those responsible for execution of a firm’s §8(e) responsibIlities iay be relieved from liability for failure to report direct’ 1 to EPA if they use the firm’s Internal system for re23rtlng §3(e) Information. This internal system is explai”ei in the Policy Statement. Information which reasonably supports the conclusion that a chemical substance or i xture presents a substantial risk of injury to health or the environment must be reported to EPA. The substantiality of the risk is based on the serious- ness of the effect and the probability of its occurrence. (This oetermlnatfon does not include consideration of economic or social benefits of t’ie use of the chemical.) In the case of a chemical causing a serious effect In a human or a group of humans, the mere fact t”at a chemical is in commerce constitutes sufficient ev’ nce of exposure to warrant report. irig. Serious effects o se’ved in an nal studies or during ------- -4. the course of environ ental st dies must be reported if there is a Potential for significant levels of exposure. Tw types of substantial risk information must be reported under §8(e): 1) information concerning effects of and/or exposure to a specific chemical in a non-emergency context, and 2) information concerning emergency incidents of environ- mental contamination, irrespective of common knowledge about the effects associated with the chemical(s) involved. 1) Non-emerg _ ency Chemical soecific effects whiCh must be reported include: a) Human health effects including any instance in a human or pattern in a group of humans of cancer, birth defects, mutagenicity, death, or serious or prolonged incapacitation; any pattern of effects or evidence in animal studies which reasonably supports the conclusion that the chemical can produce any of the preceding ef- fects. b) Environmental effects Including widespread, previously unsuspected distribution, pronounced bloaccumulation coupled wft potential for widespread exposure and any non-trivial adverse effect; any non-trival adverse effect associated with a chemical known to have bioa-ccumulated to a pronounced degree or to be widespread in environmental media; ecologically significant ------- -5- chanjes in species interrelationships; facile transfor,ati n or degradation to a chemical having an unacceptable risk. 2) Emergency incidents which must be reported include any environmental c3ntamination by a chemical substan- ce or mixture which because of the pattern, extent, and amount of conta -linatlon a) seriously threa:ans humans with cancer, birth defects, mutation, death or serious or prolonged incapacitation orb) serious- ly threatens non-hu ian organisns with large scale or ecologically significant population destruction. The definition of “emergency incident” includes all Incidents which would be considered ‘environmental eniergen- des”, with the excep.ion of emergencies f3r which reporting Is already required under the notification of spills provision of §3fl(b)(5) of FWPCA. “Substantial risk’ information need n3t be report- ed if It: 1) has been published by EPA; 2) has been submitted in writing to EOA pursuant to another authority administered by EPA as long as It is ideritif1e 1 as a §8(e) notice; contains information required by the “Policy Statement”; and is submitted within time limits required .for §8(e) notices. 3) has been p .blished in the scientific litera- ture and referenced by certain abstract services; ------- -6- 4) Corroborates well established adverse effects already documented in the scientific literattire and referenced in one of the specified abstract services; 5) is contained in a notification of spills under §311(b) (5) of the Federal Water Pollution Control Act. 6) is information about effects that the respon- dent knows have been brought to the A m -n•istra- tot’s attention. A notice of substantial risk shall be sent to the Document Control Officer, Management Support Division, Office of Pesti- cides and Toxic Substances (OPTS) (WH -557), Environmental Protection Agency, Rm. E -447, 401 M Street, S.W., Washington, D.C. 20460. A notice should: 1) be sent by a method permitting verification of its receipt by the Agency; 2) state ft Is being submitted in accordance with §8(e) 3) contaIn the name, address, job title, phone number and signature of the person reporting and the name and address of the manufacturing, process- ing or distributing establishment with which he Is associated; 4) identify the chemical substance or mixture includ- ing, if known, the CAS Registry Number; ------- .7- 5) stIr;iarlzc adverse cffc:’.s dc cribing the nature and exteii f thc risk; 6) COntain the specific source of information and a Summary and source of any supporting technical data. 7) contain co ip1ete copies of all supporting in- forriation. i.e., protocols, reports, surveys, data, etc. f. Reporting Timetable Tyoe of substantial risk information Reportina Deadline Any substantial risk infori,ation which a person possesses before January 1, 1977 and of which he is aware_after_that_daze May 16, 1978 . Chem1ca specific infor iation on non .er erçer.cy healtn or environ- mental effects In writing 15 days after obtained Erergency incidents of envi ronmental contamination lri iediately by telephone 15 days later in writing 1) [ n’or ’iat1on received orior to effective date of ISCA Any substantial risk information possessed by a person prior to January 1, 1977, and of which he was aware after that date had to be reported by May 16, 1978. A person is considered to be “aware’ of: a) any Information reviewed, or referred to in dis- cussions and conferences prior to or after January 1, 1971; ------- -8- b) any information to which the person haS eeri alerted after January 1, 1977 including any information concerning a chemical for wnich t e person is presently assessing health and environ- mental effects; c) any pre-1977 information which becomes Subst n- tial risk information in light of new circum- stances d) any other information of which the person has actual knowledge. 2) Non-eer;ency s bstartia risk information A person rrust report non-emergency substantial risk infarr atioi thereinafter referred to as substantial risk inforr .a:ion) to E’A within 15 working days of having obtained it. A person is corsidered to have obtained information at the time he first comes into possession of, Knows of, or could reasonably be expec- ted to possess or know of the information. Supplementary information generated after a §8(e) notification should also be immediately reported. 3) Emergency incident information A person must report an emergency incident to EPA Immediately by telephone giving as much of the informa- tion requ1re t §701.93 as possiDle. A complete ------- -9- written rc por •‘ is bP su5ti tt ‘‘1 t •L! ’ ’ ii• working days or th incidc ts 0ccurrnnc . IT!. R ’gulated. 1 dus ry The S(’ ) repor 1iig requlrc’flerit affectss all ri n fjc_ turers (including nlporters), processors and diStributors of chemical subst3nces and mixtures. The following ty’es of chemical substancc s an mixtur. s are affected by :his reg.i1 t ion as defined in sections 3(2) and 3(e) of 15C’. 1) those for distri ut icn in commerce, includinq tes _ market prodjcts, 2) catalysts, and in er iec1iates, 3) those fo e cl 3i,e us by :hc jnufacturer or processor 4) products for r?sc rch and evcloprient. ------- J ------- PfIN MASTER RECORD * * z * NON—CEl * REPORT DATE: 07/13/89 NON—CB 1 * * * PITh NUMBER: P—89—0729 PROGRAM MANAGER: DYNAMAC DAY RECEIVED: 5/18/89 TECH. INTEGRATOR: END OF NOTICE PERIOD! 8/15/89 FR 5CD)2:VOL! PG: DATE: INTERIM STATUS: AS OF! DISPOSITION: FOCUS DROP AS OF: 6/8/89 STATUS UPDATE REPORT PAGE: 1301 CHEMICAL NAME: 4_(L+,5—djhydrO_4_((5_hydzoxy_3_methyl_1_(4_sulfoph enyi)—(1H)—pyrazol—4y1)methyiene)—3—methyi—5—oxy—1 H—pyrazoi—1—yi)ben enesu1fonic acid dipotassium sa it GENERIC NAME: NO SUBMITTER NAME: Eastman Kodak Company SUBMITTER CITY: ROCHESTER STATE! NY DOMESTIC OR IMPORTED: DOMESTIC DATE 5(C) EXT. SIGNED: TANDARD REVIEW DATE! DATE OF ENFORCEMENT! SUSPEND DAY IN REVIEW PROCESS! 0 REVIEW DAY: 21 DATE OF NOC: NUMBER OF DAYS PAST REVIEW PERIOD PIANUF. COhN: 0 SUSPENSION: RESTART: DAYS IN SUSPENSION: 0 DATE VOLUNTARY CONTROLS AGREED TO: VOLUNTARY TEST TYPE: DATE VOLUNTARY CONTROLS AGREED TO: 1) 1) 2) 2) 3) 3) 4) ‘4) 5) 5) VOL. ACTION COMMENTS E5 TEST TYPE! 1) SE TEST DATE! 1) 2) 2) 3) 3) 4) 4) 5) 5) ------- Review Process Review DAY 1 PMN RECEIPT ‘p DAY8.12 [ 5 I DAY 9.13 ‘I, New Chemic Standard Drop for some polymers meeting select criteria(25%) DAY 15-19 PP&4s-DROP or 0ROP OLLOW .UP (50%) EXPOSURE-BASED 5(s) CATEGORIES (15%) STANDAIV REVIEW ((or additional concerns) (10%) FOCUS MEETING 1 TEST MARKET EXEMPTIONS GRAJIT OR DENY r;:: POLYPER EXEIWFIK)NS GRANT OR DENY LOW VOLUME EXEt V1IONS GRANT OR DENY DAY 44-48 DAY 57-65 DAY 23-27 _________ WORKPLAN I el MIO cOURSEL J MEE11NG J 4 , v _I ME_JT 1 P] (1st DRAFT I (2nd DRAFT DAY 38.43) 4 DAY 56-58) REQUEST ADDITIONAL RESOURCES TO ADDRESS CONC (*1S DAY 72-75 HERDiEID BRIEFING (Final DRAFT / DAY 66-71) 4p( PNMB OPTIONS - MEETING DAY 74-78 DISPOSITION MEETING DISPOSITION MEETING DROP or DROP! FOLLOW-UP DROP or DROP! FOLLOW-UP DAY 79-82 DIVISION DIRECTORS BRIEFING 4 ! POST-DDs (if Regulatory Action) AAIOPTS SIGNS 5(e) ORDERSiSNURS ------- • THE PREMANTJFACTURE NOTIFICATION (PMN) PROGRAM FOR NEW CHEMICAL SUBSTANCES I. Overview of the New Chemicals Program; a. TSCA was enacted in 1976. Section 5 of the statute was designed to enable the Agency to review activities associated with manufacture, processing, use and disposal of any new chemical substance before it enters the market p1 ce. If necessary, EPA is empowered to take action to prevent unreasonable risks before they occur (pollution prevention at its basic level). This is accomplished by requiring premanufacture reporting. b. Section 5 does not require chemical companies to test their new chemical substances for potential toxic effects. Therefore, EPA’S review (and 5(e) regulatory actions) are often conducted in the absence of data. The Agency relies on Structure Activity Relationships (SAR) to make predictions. c. The program has been in place over 11 years and has reviewed 15,000 notices. Regulatory actions have been taken in 9% of the cases (nearly 1000 actions), no successful legal challenges have been made to new chemicals regulatory efforts. d. The program continues to improve. As experienced is gained, and data gathered, our review process has become trimmer and swifter. e. The volume of work is high. The number of cases reviewed per year has generally increased steadily. The percentage of cases regulated has increased under new policies. II. Background on Section 5 Authorities/W.v Ch.mical Requirements; a. Section 5 of TSCA mandates EPA to review the potential health and environmental effects of “new chemical substances” prior to manufacture or import. ------- —2— b. TSCA defines “New Chemical Substances” as chemical substances not listed on the TSCA Chemical Substances Inventory and not otherwise excluded by the regulations. The Inventory includes chemicals in commercial production between 1975 and 1979, and subsequent chemicals reviewed in the PMN program which have been commercially produced. The Inventory currently contains over 65.000 chemical substances, of which, 5,000 additional substances have been added to the Inventory through the submission of notifications of commencement to manufacture (NOCs) after those substances had completed the P)fl review process and were manufactured for commercial purposes. c. Under TSCA section 5(a), a person who intends to manufacture or import a new chemical substance must submit a premanufacture notice (PI’DI) to EPA at least 90 days before commencing this activity. The term “MANUFACTURE” includes “IMPORT”. d. Chemicals Not Subject to P)W. Six product categories are exempt from TSCA’s regulatory authorities: mixtures; pesticides; tobacco; nuclear material; firearms and ammunition; food, food additives, drugs, cosmetics, and devices. Other new chemicals “excluded” from the requirement to submit a PMN include: - Substances imported as components of articles, - Chemicals manufactured and processed (the manufacturer must know that processing is occurring for export only) solely for export in accordance with section 12 of TSCA. However, if a new chemical substance will be used in the U.S. this exclusion does not apply, - Chemicals manufactured as byproducts with limited commercial purposes, - impurities, - Non—isolated intermediates. e. Exemptions from PPW Review: o New chemical substances may be “Exempted” from PMN requirements if they are: - Manufactured in small quantities solely for research and development (R&D) in accordance with all pertinent regulatory requirements, ------- —3— — Manufactured or imported subject to test marketing, low volume (< 1,000 kg/yr), or polymer exemptions granted by EPA. o Substances manufactured in small quantities solely for R&D: - R&D includes synthesis of new chemical substance or analysis, experimentation, or research on new or existing chemical substances, including product development activities. R&D may include tests of the physical, chemical, production, and performance characteristics of a substance. - The term “small quantities” is defined in the PMN rule as “quantities not greater than reasonably necessary for R&D”. What are “small quantities” in any given case would therefore depend upon the nature of the R&D activities. - Persons who engage in R&D for, or obtain an R&D chemical from, a manufacturer must be notified of any risk to health which may be associated with the chemical. However, R&D conducted entirely in laboratories under prudent practices are exempted from the requirement for risk evaluation. The notification requirements appear in the PMN rule. - Use of any R&D substance must be supervised by a “Technically Qualified Individual.” - The following records must be retained: information reviewed and evaluated to determine the need to make any notification of risk, documentation of the nature and method of risk notification, documentation of prudent lab practices used instead of risk notification and evaluation and, if an R&D substance is manufactured at greater than 100 kgs/year, records regarding the chemical identity of the substance to the extent known, the production volume, and the disposition of the R&D chemical must also be retained. - Manufacturers and importers who distribute an R&D substance to other persons must provide those persons with written notification of known hazards and of the requirement that the substance be used solely for R&D. - The R&D exemption is self-implementing; companies are not required to notify EPA on exempted R&D activities. ------- —4— o Test—Marketing Exemptions: - Test—marketing involves distributing in commerce - a limited volume of a chemical to specified number of customers for a limited period of time to determine market acceptance. - The manufacturer must submit a test-marketing exemption (TME) notice to EPA at least 45 days prior to manufacturing the substance. - EPA will grant the TME if it determines that activities involving the substance will not present any unreasonable risk of injury to health or the environment. o Low Volume Exemptions: - This exemption is available for substances manufactured in quantities of 1,000 kg or less per year. Only one exemption is available per substance regardless of the number of potential manufacturers. Low volume substances are not added to the TSCA Inventory; however, a separate inventory of LVEs granted is maintained. - The manufacturer must submit a low volume exemption (LVE) notice to EPA at least 21 days prior to manufacturing the substance. The notice must include the site of manufacture, which is legally binding upon the company. - The manufacturer may also provide information on exposure controls. If provided, it is also binding. - EPA will grant the LVE if it determines that the • substances will not present an unreasonable risk of injury. o Polymer Exemptions: - This exemption is available for certain classes of polymers which are not chemically active or bioavailable. - The manufacturer must submit a polymer exemption notice to EPA for a 21-day review. EPA will grant ------- —5— the exemption if it determines that the substance will not present an unreasonable risk of injury. - Unlike the other exemptions, substances subject to polymer exemptions are added to the Inventory when - commercial production commences. f. The PMN form is attached for reference. P O submitters must include information on the substance identity, uses, estimated production volume, description of byproducts, description of human exposure, description of disposal practices, and health and environmental test data which are available to the submitter at the time of submission. Although toxicological data need not be developed solely for the P101, it must be submitted to the extent the data are “Known to or reasonably ascertainable by” the submitter, and within its “possession and control”. III. Regulating New Chemical Substances Under TBCA. Section 5(e) and 5(f) of TSCA authorize EPA to prohibit or limit the manufacture, processing, distribution in commerce, use, and disposal of a new chemical substance if EPA makes the following determinations: a. Section 5(e) Findings: o Available information on the substance is insufficient to permit a reasoned evaluation of its health or environmental effects; and o (A) The manufacture, processing, distribution in commerce, use, or disposal of the substance may present an unreasonable risk of injury to health or the environment (referred to as a “may present” determination); or (b) the substance will be produced in substantial quantities and (1) may reasonably be anticipated to enter the environment in substantial quantities, or (2) there may be significant or substantial human exposure (Referred to as an “Exposure-based” finding). b. Section 5(f) Findings: o There is a reasonable basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal of the substance will present an ------- —6— unreasonable risk of injury to human health or the environment before a TSCA §6 rule can be issued to prevent the risk (referred to as a “will present” determination): o A section 5(f) rule , which limits activities involving a new substance, is a section 6(b) proposed rule which is immediately effective upon proposal. A section 5(f) order prohibits all activities involving the substance. o To date, EPA has issued 3 section 5(f) rules and no section 5(f) orders, although some P)O s have been withdrawn from review after EPA notified the submitters that we intended to ban the substances. c. Practices Under Section 5(e): o To date, there have been five outcomes, depending upon the facts of the case, when EPA makes a determination under section 5(e): - The company may withdraw the P Oi. - The company may develop toxicity information sufficient to permit a reasoned evaluation of the health or environmental effects of the substance prior to the conclusion of the review period (“upfront” or “voluntary” testing). Where exposures or releases cannot be controlled pending testing to address EPA’S concerns, or the requested testing is relatively cheap and not very time- consuming, this may be the only option available to the P1W submitter short of withdrawing the PMN. - The company may develop and provide to EPA other information on the potential effects of the substance or its analogues, the potential exposures, or both, which if accepted by the Agency, would negate the potential unreasonable risk determination. - The company may, together with EPA, suspend the notice review period, and negotiate and enter into a section 5(e) Consent Order. The Consent Order would permit limited manufacture, processing, distribution in commerce, use, and disposal of the substance pending the development of information. A Consent Order may contain a requirement that toxicity data be submitted to EPA when a specified ------- —7— volume of the chemical has been produced. This production volume level is set where EPA estimates that profits from the chemical will support the - cost of testing. - The company may refuse to withdraw the PI I, negotiate a Consent Order with EPA, and/or conduct up-front testing or develop other information. EPA would then unilaterally develop a Proposed Order, under the procedures in section 5(e), to ban manufacture or import. o Consent Orders have included one or more of the following requirements: - Protective equipment, including impervious gloves, safety goggles, protective clothing, or respiratory equipment, - Worker Training Programs, — Distribution Restrictions, - Use Restrictions, - Labels, material safety data sheets (MSDS), and notification letters, — Disposal limitations, — Recordkeeping Requirements, - A Production Volume “Testing Trigger”, — A separate “Consent Order for Contract Manufacture”, used in situations where the PMN submitter has contracted out the actual manufacture of the substance to another company. d. Who Decides. Decisions to regulate under 5(e) are primarily made now at the Division Director’s level (at the DD’s meetir g). However, a number of non—controversial decisions on clear cut risk-based cases (and exposure based cases) are also delegated to the Focus meeting. This has permitted the PMN review program to handle a large volume of cases on the basis of its combined experiences. Ultimately, the AA for OPTS is responsible for 5(e) decisions as he/she must sign all section 5 orders. ------- —8— Iv. statistics (see attachment) Data on Submissions: PMN Submissions (since 1979) 12,128 ThEA Exemptions (since 1979) 487 Low Volume Exemptions (Since 1985) 960 Polymer Exemptions (Since 1985) 1,042 Total New Chemical Submissions 14,617 Data on Regulatory Actions Section 5(e) Orders Issued 292 Section 5(f) Actions Issued 16 Withdrawn in Face of Action 565 Upfront (Voluntary) Testing Actions 205 Total Cases Regulated 1,078 (Expressed as a % of PMNs = 9%) Notices of Commencement of Manufacturer NOC’s Received 4,991 As % of Cases (PMNs) Reviewed 41 % Data on Exposure—Baled Policy Total Cases Targeted (since 2/88) 138 Cases reviewed (since 2/88) 2,421 Percentage of Cases Targeted 6 % Prenotic. Consultations Average Per Year 1,000 ------- Total Section 5 Submissions bj ,FiccdYcr 3- 26 24- 22- 2- 000 - i.e ‘.4 , £ I. b 12. ct6’ 1.1 1 1i.1 Q4. ____ 0 1979 i r 1981 19 1983 1984 I9 19M 19W 19 ------- Section 5(e) Orders LyFi.edYcr 70 U n f l 1979 19W 1981 19 1983 1984 I9 1985 1987 1985 ------- Receipt of Voluntary Test Data Fused Ycr 1979 I9 1981 19 1983 198* 19S 1986 1987 1986 ------- -9— V. The P W Review Process. EPA developed the PMN review process to meet the statutory mandate of TSCA §5. Any person who intends to manufacture or import a new chemical substance is required to provide to EPA available data on the chemical structure, production, use, release, exposure, and health and environmental effects. EPA utilizes an integrated approach that draws on knowledge and experience across disciplinary and organizational lines to identify and evaluate concerns regarding health and environmental effects, exposure and release, and economic impacts. The P) 1 review process is outlined schematically on an attachment. Each P W proceeds through a screening process to determine whether more detailed review is required and to identify candidates for regulatory action. EPA focuses on the relatively few new chemicals of greatest concern—-those which are structurally related to known toxic chemicals, and those about which little is known. a. Notice Intake/ Administrative Screen. At this stage, notices are reviewed for administrative and legal completeness. Incomplete notices, and those for which the required fee has not been submitted, are not reviewed. b. Initial Screen. P)O notices go through a multidisciplined initial review designed to ascertain whether regulatory action on a more detailed analysis is warranted. Preliminary Chemistry, Structure Activity Relationship (SAR) Analysis, Exposure, and Environmental Fate analysis are conducted. c. Use of SAR in Hazard Assessment. Given the qualitative and quantitative limitations of the test data provided with PP (S, EPA has had to develop innovative approaches to characterize the potential hazards associated with new chemical substances . The generic term applied to these approaches is structure activity relationship (or SAR) ana].ys.is. The major components of EPA’S SAR-based approach to hazard analysis are the following: — Critical review of submitted test data, if any, on the PIaI c’ e-’ ical; — identification and selection of potential analogues and/or prediction of key P) 4 metabolites, followed by critical review of test data available on these chemicals; — use of QSAR (Quantitative Structural Activity Relationships) methods when available and applicable; and ------- —10— - the experience and judgement of scientific assessors in interpreting, weighing, and integrating the often limited information yielded by the above hazard analysis components. The knowledge and experience in OTS in assessing the fate and effects of chemicals having limited data are unparalleled in the Agency and, to a large extent, throughout the world. More and more EPA program offices and others are beginning to recognize the fact that most of the chemicals confronting the environmental assessors have at best limited data available. This is encountered in hazardous waste sites or environmental monitoring surveys, etc. Over the years, OTS has come to be widely recognized for its abilities in assessing the potential hazards of chemicals having limited data. OTS has handled requests for SAR evaluations from many Agency offices (e.g. ORD, OERR, OSW, OAR, ODWI OWRS, OPP, and regional offices), other federal agencies (State, DOD) and a number of state environmental protection programs (e.g. N.J., Co.), and the OECD’s high volume project. The TSCA PMN reporting requirements can be contrasted with the European Economic Communities (EEC) “premarketing” notification requirements established under European Communities Directive 79/831/EEC. However, as the terms indicate, premanufacture notification under TSCA is required at an earlier point in the development of a chemical than is the case for the EC’s premarket notification procedure. Many of the information reporting requirements under the EC directive are similar to those in TSCA with the major difference that the EC directive requires, as a mandatory part of the notification, a specified “base set” of health, environmental, and physical chemical test data. Therefore, a minimum set of test data is thus available on premarket notification EC chemicals, whereas the hazard assessment of TSCA P) I chemicals often starts out with fewer or no data. d. Cases completing their initial review are brought to the first regulatory decision meeting called Focus. At this meeting the CCD decision maker receives reports from the initial rev,iews prepared by each discipline and determines whether to drop a case from review, hold it over for more investigation (standard review) or move directly toward a regulatory 5(e) outcome for certain standard classes of chemicals. ------- —11— e. For chemicals which are not screened out early, the standard review includes: — Conducting a chemistry analysis, - Identifying structurally analogous substances - Searching the literature for toxicity data, - Analyzing available test data on a substance or analogous substances, — Analyzing potential releases to the environment, - Calculating exposures to workers and the general population, - Calculating potential concentrations in surface waters, - Investigating additional uses which could significantly alter exposure. f. Cases completing standard review are taken to the Division Directors’ meeting for a final decision. The DD’s meetings are chaired by CCD with senior representatives from each division (and discipline) present. The DD’s meeting can result in a decision to drop a case from further review, to regulate (and require controls) under section 5(e) or 5(f), or to “ban” the substance pending the receipt and evaluation of “upfront testing”. g. If a regulatory decision to impose certain controls is reached, CCD staff communicate and negotiate with the submitter. Similarly, if “upfront” is required, this decision is communicated by CCD. h. As section 5(e) orders are always “pending’ the developaent of data, EPA rust respond when data are submitted. This is a more frequent occurrence due to our “triggered testing” program under which data must be submitted prior to reaching a specific production volume. Often, negotiated orders must be modified to reflect the evaluation of new data. i. Notice of Commencement (NOC) to Manufacture or Import. An NOC is submitted once commercial production of a chemical substance is initiated. The substance is then added to the TSCA Inventory. ------- —12— j. Key New Chemicals Program Contacts. The following persons are key participants in the PPOJ review process and may be contacted for more specific information on TSCA section 5 and the P!’flJ review process: - Chemical Control Divisions John Melone, Director; Lawrence Culleen, Chief, Premanufacture Notice Management Branch (PNMB); Paul Matthai and Rose Allison, Section Chiefs, PNMB, - Health and Environmental Review Divisions Charlie Auer, Acting Director; Ray Kent, Section Chief, Chemical Review and Evaluation Branch; Vincent Nabholtz and Pauline Wagner, Environmental Effects Branch, — Economics and Technology Division: Mike Shapiro, Director; William Burch, Chief, Chemical Engineering Branch (CEB); Paul Quillen, CEB; Neil Patel, Regulatory Impacts Branch and Paul Bickart, Industrial Chemistry Branch, — Exposure Evaluation Division: Elizabeth Bryan, Chief, Exposure Assessment Branch (EAB), Greg Schweer, EAB; Lynn Delpire, EAB, — Information Management Divisions Frank Caesar, Chief, Confidential Data Branch; Henry Lau, Section Chief, Inventory. Additional P1W Contacts: - Mary Cushmac, Prenotice Coordinator (202) 382-3745 (“Pre- noticew questions, including when a P101 is required and the type of information that should be included in a notice), ------- —13— vi. significant New Use Rules (SNURS) a. Because information reported in a P O1 is not binding on the submitter, and because section 5(e) orders are binding only upon the PMN submitter, EPA must issue “follow-up” regulations to effectively control deviations from its own risk analysis or unregulated practices commenced by secondary manufacturers. These are SNtJRS which may define certain (disapproved) activities as “new uses” subject to reporting 90 days before they are commenced. VII. Issues a. New (versus existing) Chemicals Bias. To the extent the Agency has reviewed and regulated new chemicals without concomitantly regulating existing chemicals of like (or greater) toxicity, it has been accused of a “New Chemicals Bias”. c. Confidential Business Information. Section 14 of TSCA permits submitters of P s to claim specific portions of their submissions to be confidential business information (CBI). Special CBI handling procedures within OTS are required. The implications for resources and staff are staggering, as nearly all new chemical submissions contain some claims of CBI. VIII. “Hot” Topics a. CPC 8ubstitutes. New chemical substances intended to replace existing chemical CFS being phased out under the Montreal Protocol will be reviewed under the New Chemical Program. EPA will be forced to balance such considerations as ozone depletion potential and toxicity to workers/ consumers who may be exposed to potentially more-toxic substitutes. b. Acrylats Agreement. As part of a long-sought voluntary agreement, EPA and the Chemicals Manufacturers Association recently entered into a toxicity testing program under which cx will perform long-term chronic toxicity testing on chemicals within a class which have proved difficult within the new chemicals program. In exchange, EPA will loosen its labeling restrictions while continuing to require strict worker protection and hazard communications (MSDS) restrictions. ------- —14— c. Pollution Prevention/Relative Risk. Evaluating chemical related risks and making regulatory decisions before a substance enters the market place is the best pollution prevention strategy we at EPA have. Intervention prior to permitting risks to occur is the basis of the New Chemicals Program. Further, in reaching a decision whether to permit a new chemical to enter the market place, EPA tries to encourage safer chemicals to succeed in commerce and replace their riskier counter parts which are already available. Therefore, a “relative risk” policy has always beer a component of the New Chemicals Program. The “relative risk” policy allows EPA to minimize regulatory burdens on new chemical substances that will substitute for more toxic chemicals that are already in wide-spread use. This policy is designed to reward and encourage industrial innovation if it results in the development of safer new chemicals. More recently, EPA has been considering taking a variety of additional actions to better promote pollution prevention including working directly with individual companies to encourage them to improve their waste minimization practices. IX. Trends/New Directions a. Expedited P0110w-up Rule. The EPA has nearly completed rulemaking which will establish an expedited process for issuing section 5 (a) Significant New Use Rules (SNURS). The new process will enable EPA to more quickly extend by rule the restrictions imposed upon original P submitters through section 5(e) consent orders to all subsequent manufacturers, importers and processors of the subject new chemical substances. The rule will also enable the Agency to expedite promulgation of SNURS for those new chemical substances for which no section 5(e) consent orders have been issued, but which may present hazards to human health or the environment if exposures or releases are significantly different for those described in the P1w. b. Ussr lees. In October of 1988, EPA began collecting user fees for P101 reporting. A $2,500 fee became required for most new chemical submissions which may result in the collection - f n-’arly $3 million for the U.S. Treasury in FY 1989. These funds would require an appropriation by Congress to become available to EPA use. c. Initiatives. OTS senior managers have recently completed a series of analyses which examined both long and shorter term methods for further streamlining the New Chemicals program. These reports were submitted to the Office Director for review and discussions at that level are expected to follow. Long term initiatives recommended ------- —15— include regulatory revisions designed to reduce the number of new chemical submissions and abbreviate time devoted to preparation of consent orders. d. Nov and Existing Chemicals Program Integration. OTS is currently emphasizing ways to more fully integrate the new and existing chemical programs to eliminate any new chemical bias. e. Exposure Based Policy. Recently, EPA implemented a policy designed to further enhance our ability to get test data on new chemical substances. Under this program EPA has begun to require basic toxicity testing for all high-volume new chemicals if the Agency believes there will likely be substantial or significant human exposures or substantial environmental releases of the chemical. The objective of the policy is to obtain more test data on those new chemicals that demonstrate the greatest potential for human exposure or release to the environment. This program on high—volume chemicals has been in place for over a year now and we are beginning to see the results of the test data now. ------- AL-RBEc0: 5(e) Action Letter - Risk-Based Ecotoxicity Re: P!’ThJ-8 Dear ___________________ This letter concerns the above-referenced premanufacture notice (“PMN”) which you submitted pursuant to section 5(a) of the Toxic Substances Control Act (“TSCA”) and 40 CFR Part 720. The PMN described the chemical substance as _______________ (insert trade name from item 5 on page 5 of P!0T, or specific name if trade name unavailable]. The Environmental Protection Agency (“EPA”) has determined, under section 5(e) of TSCA, that the available information is insufficient to permit a reasoned evaluation of the environmental effects of the PMN substance, and that the manufacturing, processing, distribution in commerce, use, or disposal of the substance may present an unreasonable risk of injury to the environment. This letter provides you with the basis of EPA’s determination of potential unreasonable risk and describes your options in light of this determination. This determination is based on Quantitative Structural Activity Relationship (QSAR) derived from test data on structurally similar ________. Based on this OSAR, EPA expects toxicity to aquatic organisms to occur at a concentration of _______ P ’2I substance in surface waters. EPA expects releases of this Pt fl4 substance to water to result in surface water concentrations significantly exceeding that concern level. Given EPA’s determination under section 5(e), EPA will regulate this substance pending the development of sufficient information. Your company has several options available. The first option is for EPA and your company to enter into an expedited section 5(e) Consent Order. The Consent Order would permit limited manufacture, processing, distribution in commerce, use, and disposal of the substance, pending the development and review of information addressing the potent ial risks. Signing the Order would not constitute an admission by your company as to the facts or conclusions underlying the Agency’s determination in this proceeding. ------- 2 Enclosed is a copy of a generic section 5(e) Order. The generic Order provides an example of the standard language EP uses in section 5(e) Orders of this type. Please note, however, that the generic Order was developed for various possible cases and therefore many of its provisions may not apply to this P J substance. For this PMN substance, the Consent Order would require your company to: submit to EPA the following toxicity testing sixteen weeks before manufacturing or importing kilograms of the P substance: 1. A 96-Hour Bioassay in Alagae (40 CFR 797.1050), 2. A 48-Hour LC 50 test in Daphnia (40 CFR 797.1300), and 3. A 96—Hour LC 50 test in Fish (40 CFR 797.1400); ) comply with the Hazard Communication Program labeling, Material Data Safety Sheet (MSDS), and worker training provisions; ) not manufacture the PP substance ____________________________ ) not process the PMN substance ________________________________ ) not use the PMN substance ____________________________________ distribute the P!* substance only to a person who agrees ’ to follow comparable restrictions or __________ ; distribute the PMN substance only dispose of the PMN substance only by ( ) not release the PMN substance into the waters of the United States ______ and ( ) maintain relevant records. This PMN is a candidate for an expedited concurrence procedure which the Agency is employing to reduce development tune for 5(e) Consent Orders. Under this procedure, an Order with the previously—described provisions will be drafted in final form directly from the standard Order language, signed by the Assistant Administrator for the Office of Pesticides and Toxic Substances, and sent to you for signature. This would allow you to commence manufacture immediately after EPA’S receipt of the Order with your signature, instead of waiting for further internal Agency review and concurrence. To take advantage of the expedited concurrence procedure, you must agree to accept the signed Order without modification . To begin work developing the Consent Order, EPA will require from you a written suspension of the PPTh review period for at least 60 days to permit development of the Order. This is the minimum period of time required to develop and obtain final ------- 3 signatures for a section 5(e) Order. Additional suspensions to provide more time may be required if, during the development process, your company presents new facts which necessitate modifications to the Order language. If, however, any suspension time remains in effect when the Order is signed, EPA will revoke the remainder of the suspension period to make the Order effective immediately. Suspensions of the PMN review period are authorized by 40 CFR 720.75(b). After your company commences manufacture of the r* substance and submits a notice of commencement (“NOC”) of manufacture within 30 days as required by 40 CFR 720.102, EPA will add the substance to the TSCA Chemical Substances Inventory maintained pursuant to section 8(b) of TSCA. The substance will. no longer be a “new chemical substance” as defined by section 3(a) of TSCA. Consequently, any other company may manufacture the substance without being required to submit a r i or comply with any other restrictions under section 5 of TSCA, unless EPA promulgates a “significant new use rule” (“SNUR”) pursuant to section 5(a)(2) of TSCA. Therefore, if a Consent Order is developed for this PMN substance, EPA intends to develop a SNUR concurrently with the Consent Order. The SNUR will contain essentially the same provisions as the Consent Order and will extend those provisions to all other companies which manufacture, import or process the P! .Th1 substance after the effective date of the rule. According to section 5(a)(1)(B) of TSCA, any company wishing to deviate from the provisions of a SNTJR must submit a significant new use notice to EPA at least 90 days before doing so. Rulemaking procedures to develop a SNUR requires more time than development of a Consent Order. However, the Agency expects to promulgate the SNUR for this PMN substance using the expedited procedures for SNUR development which are expected to be promulgated at 40 CFR 721.160. This means that EPA could promulgate a SNUR for this substance within as few as 180 days from receiving your company’s NOC. As a second option, you may elect to discuss modifications to the standard language of the Order. However, any modification to standard Order language will significantly lengthen the amount of time required to develop both your Order and the corresponding SNUR. Any deviation from the standard language will necessitate more extensive Agency review, making the expedited procedures impossible. If you wish to pursue this option, you should submit to EPA a written suspension of at least 90 days. Additional suspensions may be required depending upon the complexity of the changes being sought and the amount of time your company spends reviewing the document. The third option is, before commencing any manufacture or import of the PMN substance, to develop and submit information sufficient to permit a reasoned evaluation of its environmental effects. To pursue this option, you must agree to suspend the ------- 4 PMN review period for a time period sufficient to permit development and review of the test data identified above. Other information On the potential effects or exposures of the PMN substance might also negate EPA’S finding of potential unreasonable risk. EPA strongly encourages you, before performing any testing, to consult with the Agency concerning selecting a protocol or developing the information. Published test guidelines (e.g., 40 CFR 797 and 798) provide general guidance for development of test protocols, but are not themselves acceptable protocols. Test data should also be developed according to TSCA Good Laboratory Practice Standards (GLPS) at 40 CFR Part 792 (48 FR 53922; November 29, 1983) and through the use of methodologies generally accepted at the time the study is initiated. Failure to obtain protocol approval or follow GLPS could result in data insufficient to permit a reasoned evaluation of the effects of the substance. Any test data submitted should include protocols, raw data, and results. After the testing is completed, it will be reviewed and analyzed by the Agency. If the testing indicates the potential for chronic effects, EPA may require you to conduct further testing. If the test results indicate that the P1*1 substance poses a risk of acute and/or chronic toxicity to aquatic organisms, the Agency may regulate to control release to surface waters. The fourth option is to withdraw your P1*1. Such a withdrawal will not prejudice any right to resubmit in the future a P 1*1 or exemption notice for the sante substance to EPA under section 5(a) or 5(h) of TSCA. A written notice of withdrawal must be sent to EPA in accordance with 40 CFR 720.75(e). Within 30 days of your receipt of this letter, please complete and return to EPA’S Program Manager the enclosed “Selection of Regulatory Options” form, which will notify EPA of your company’s decision as to which option it wishes to pursue. If you decide to pursue upfront testing or a section 5(e) Consent Order, you should also include on the enclosed form a written suspension of the P1*1 review period. If you do not complete and return, within 30 days, the enclosed form indicating your decision and providing an adequate suspension of the review period to pursue one of the above options, EPA will assume that you do not wish to pursue a negotiated approach to the resolution of this P1*1 review. Under this scenario, EPA may unilaterally issue a proposed Order under section 5(e) of TSCA that may completely prohibit the manufacture, processing, distribution in commerce, use, or disposal of the P1*1 substance pending the development of information sufficient to permit a reasoned evaluation of the ------- 5 effects of the substance. Consequently, my staff would issue a notice under section 5(c) of TSCA extending the Pr review period to 180 days to permit development of the Order under section .5(e). In addition, you would be contacted by a representative of the Information Management Division (IMD), Office of Toxic Substances (OTS), and required to substantiate all Confidential Business Information (CBI) claims in your P! as a condition of maintaining the information as CBI. Under the procedures in section 5(e), EPA would issue the proposed Order no later than day-135 of the P! review period and, on or before the day the Order is issued, notify you in writing of the substance of the determinations underlying the Order. The Order would become effective upon the expiration of the review period, unless you file with EPA, within 30 days of receiving the notification, formal objections to the Order specifying with particularity the provisions of the Order deemed objectionable and stating the grounds therefore. EPA would review the objections and decide whether to apply to a United States District Court for an injunction to enforce the terms of the Order. This process is described fully in section 5(e) of TSCA. If YOU have any questions or comments, please contact the Program Manager for this P!Th1, _______________, at (202) ------- DL-HH: Drop/Concern Letter - Human Health Re: P—88—__________ Dear __________________ t4 6:C,/tJ ” 1 This letter responds to- bur Premanufacture Notice (PMN), - - , received by the Environmental Protection Agency (EPA) on __________• 1988. The notice review period for this P?’ J expired on _________ 1988. Therefore, you are now free to manufacture or import this substance. However, EPA is concerned that exposure of unprotected workers to the PMN substance during manufacturing, processing, or use may present an unreasonable risk of injury to health. Specifically, EPA is concerned, based on test data on other ___________• that the P!4I substance may cause ______________ toxicity. At this time, EPA does not expect significant release to the environment of, or exposure of people to, the PP substance. Consequently, EPA has not determined that the manufacturing, processing, and use of the substance may present such an unreasonable risk to health or thj.en ronInent to warrant regulation by EPA. However, EPA% T7-reeei emde that, to mitigate inhalation exposure to workers, any workers who may be exposed,,to the substance during manufacturing, processing, and use wear a N gSH-approved respirator and, to mitigate dermal exposure, d1 t d wear adequate protective clothing which covers any exposed parts of the body, impervious gloves, and chemical safety goggles or equivalent eye protection. ------- Please note that 40 CFR 720.102 requires you, within the first 30 days Of commencement of manufacture or import of..t. .eq P T substance, to send a notification letter to the Document Control Officer (TS—790), Office of Toxic Substances, U.S. Envirorunental Protection Agency, Room E-201, 401 M Street, SW., Washington, D.C. 20460. This notification letter must contain the following information for the PMN substance: specific chemical identity, prexnanufacture notice number, and the date when the manufacture or import commences. This information will be used to add the new substance to the - Chemical Substance, 2Z,,i r ’17. If you wish the chein al identity to be listed on the Confidential Inventory, ’tkO’ c1aim of confidentiality must be reasserted and substantiated in accordance with 40 CFR 720.85(b). If there are any problems with the generic name to be used. EPA’s Information Management Division will contact you to negotiate a generic name that is acceptable to you and EPA. If you have any questions or comments, please contact Robert Wright, the Program Manager assigned to this PMN, at (202) 382—7800. Sincerely, Section Chief Premanufacture Notice Management Branch ------- DL-Eco: Drop/Concern Letter - Eco/Hea lth Re: P-88-_________ Dear _________________- This letter responds to your Premanufacture Notice (P!i.ThJ) P-88— , received by the Environmental Protection Agency (EPA) on _______________ , 1988. The notice review period for this P! expired on ________ 1988. Therefore, you are now free to manufacture or import this substance. However, EPA is concerned that exposure of unprotected workers to the PMN substance during manufacturing, processing, or use may present an unreasonable risk of injury to health and to the environment. Specifically, EPA is concerned, based on test data submitted with the P!*T, that the substance may cause __________ toxicity. Based on test data on other ____ _________________________• EPA is concerned that the substance may be toxic to aquatic organisms. At this time, EPA does not expect significant re1ea e to the environment of, or exposure of people to., the P!flJ substance. Consequently, EPA has not determined that the manufacturing, processing, and use of the substance may present such an unreasonable risk of health to th ç nv4 ronment to warrant regulation by EPA. However, EPA ‘iTh igIy reeominen& that, to mitigate inhalation exposure to workers, any workers who may be expose ,)o the substance during manufacturing, processing, and use £ u4d - wear a NZ9flH-approved respirator and, to mitigate dermal exposure, s 6U4-4 wear adequate protective clothing which covers any exposed parts of the body, impervious gloves, and chemical safety goggles or equivalent eye protection. EPA .also &.-i.z Z stren ly recommends that your Company’ take all measures necessary to prevent release of the PfQ substance into the environment. ------- Please note that 40 CFR 720.102 requireS you, within the first 30 days Of commencement of manufacture or import of-me ‘4 PMN substance, to send a notification letter to the Document Control Officer (TS—790, Office of Toxic Substances, U.S. Environmental Protection Agency, Room E —201, 401 M Street, SW., Washington, D.C. 20460. This notification letter must contain the following information for the P!’2J substance: specific chemical identity, premanufacture notice number, and the date when the manufacture or import commences. This information will be. used to add the new substance to the iaery—of—E dst4f -----—- Chemical Substance ç If you wish the chemical ‘identity to be listed on the Confidential Inventor claim of confidentiality must be reasserted and substantiated in accordance with 40 CFR 720.85(b). If there are any problems with the generic name to be used, EPA’s Information Management Division will contact you to negotiate a generic name that is acceptable to you and EPA. If you have any questions or comments, please contact Robert Wright, the Program Manager assigned to this PMN, at (202) 382—7800. Sincerely, Section Chief Preinanufacture Notice Management Branch ------- May 9, 1989 INDEX OF PNMB BOILERPL TES Sustension Letters File Name Premanufacture Notice SL-P Test Market Exemption SL-TME Low Volume Exemption SL-LVE Polymer Exemption SL-PE Rescind Suspension SL—RCND DroD/Concern Letters Human Health DL-MH Eco/Mea lth DL-ECO Briefina Paoers Risk—Based HP-RB Exposure—Based BP-XB Hybrid Risk/Exposure BP-HY Bring-Back BP-BB 5(e Action Letters Risk—Based Human Health Triggered Testing (Old) ALRBHHP1’.OLD Risk—Based Human Health Triggered Testing (New) ALRBHHTTINEW Risk-Based Human Health Pending Testing (Old) ALRBHHPT.OLD Rish-Based Human Health Pending Testing (New) ALRBHHPT.NEW Risk—Based Ecotoxicity (Old) AL-RBECO.OLD Risk-Based Exotoxicity (New) AL-RBECO.NEW Risk-Based Hybrid AL-RBHY El Gordo AL-EG Exposure-Based Human Health (Old) AL-XBHH.OLD Exposure-Based Human Health (New) AL-XBHH.NEW Exposure-Based Ecotoxicity (Old) AL -XBECO.OLD Exposure-Based Ecotoxicity (New) AL-XBECO.NEW Exposure-Based Hybrid (Old) ALXBHY.OLD Exposure-Based Hybrid (New) ALXBHY.NEW Risk-Based Upfront Ecotox Testing (Old) ALRBUFEC.OLD Risk-Based Upfront Exotox Testing (New) ALRBUFEC.NEW Exposure—Based Upfront Ecotox Testing (Old) AL-XBUFEC..OLD Exposure-Based Upfront Ecotox Testing (Old) AL-XBUFEC.NEW References for Health or Eco Risks AL-REF ------- 2 5(e Consent Orders Risk-Based Human Health (Old) CO-RBHH.OLD Risk-Based Human Health (New) CO-RBHH.NEW Risk—Based Ecotoxicity (Old) CO-RBECO.OLD Risk-Based Ecotoxicity (New) CO-RBECO.NEW Exposure—Based Human Health (Old) CO-XBHH.OLD Exposure-Based Human Health (New) CO-XBHH.NEW Exposure-Based Ecotoxicity (Old) CO-XBECO.OLD Exposure-Based Ecotoxicity (New) CO-XBECO.NEW Exposure-Based Hybrid CO-XBHY Worksheet COWRICSHT 5(e Consent Order Transmitta].s Order Workgroup Memo WRKGRP Transmittal Memo OTS to OPTS OPTS Transmittal Memo OPTS to OGC + OPPE OGC Transmit Draft Order to Company for Comment DRAFT Transmit Order to Company for Signature COMPSIGN Transmit El Gordo Order to Company for Signature ELGDSIGN Transmit EPA—signed Order -. to Company for Signature EPASIGN Transmit All Signed Order to Company for Records ALLSIGN 5(c Extensions 5(c) Extension Federal Register Notice 5CFR Withdraw 5(c) Federal Register Notice 5CWD Incomolete & Ineliaible Letters Incomplete Letter — PlU( INCPI 2 Incomplete Letter — PE INCPE Incomplete Letter — LVE INCLVE Ineligible Latter — LyE INEILVE Ineligible Letter — PE INELPE THE FR Notices Grant TMEGRANT Grant With Restrictions TMEGWR Denial TMEDENY Modification TMEMOD Grant with Comment Period TMECOM ------- 3 P)O Not Reauired Letters P1*1 on Inventory PMNONINV Polymer on Inventory PLYONINV Mixture on Inventory MIXONINV Non-Isolated Intermediate NNISIINT Free Radical Initator FRERADIN Surface Modified Not Subject to PMN SURFMOD Cosmetic Use COSMTCUS Ti s and ComDlaints Referral of Potential Enforcement Action TIPCOVER Referral of Potential Enforcement Action TIPFORM Miscellaneous Protocol Review Letter PRTCLREV LVE Grant/Concern Letter LVEGRANT Rule Workgroup Memo RULEWG ------- UNITED STA ES ENVIRONMENTAL PROTECTION AGENCY w sHINGroN.Dc 20460 — r,rrICCQ DESTICIDE AND TOXIC SUBSTANCES MEMORANDUM SUBJECT: Mock PMN FROM: Michael Hackett 1/ Case Officer Compliance Division Office of Compliance Monitoring (EN-342) TO: Juanita Geer Document Control Officer Office of Toxic Substances (TS—793) I am sending you under separate CBI cover (DCN 208380253)a Mock PMN which is to be designated with an “I” and processed as a PMN submission. (x) An Inventory search for this substance is required. ) An Inventory search for this substance has been conducted. Please provide me with the name of the project manager for this Mock PMN. If you have any questions regarding this matter, feel free to contact me at 475-9309. Attachment cc: Ken Moss (TS-794) Pnntod on Recydod Pa_ne’ ------- K ------- UNiTED STATES ENVIRONMENTAL PROTECTION AGENCY WASKINGTON D.C. 20460 ‘2 SUBJECT: IMD Validation of Notice df Commencement Date ‘I (TS—793) ) I 1989 PC$TICIOL ANO TONIC SUUST* c15 MEMORANDUM FROM: Linda A. Travers, Director Information Management Division TO: Charles L. Elkins, Director Office of Toxic Substances (TS-792) Pursuant to your memorandum of January 23, attached are IMD procedures for validating notices of commencement by the reported commencement date. Attachment cc: 5 .EWConroy, II F. Stiehi \ ------- VERIFICATION OF VALID COMMENCEMENT DATE. A. The DCO will examine the reported commencement date to determine whether it meets the following requirements under the P I rule: 1. A specific month, day and year must be cited. 2. The commencement date must be subsequent to the termination of the PMN or exemption review period. (The DCO staff will verify the review period for the PMN/exemption.) 3. The NOC must be received by EPA between one and 30 days after the commencement date. 4. The commencement date reported must be prior to the date the NOC is received by EPA. That is, assertions such as manufacture “is beginning,” “will begin,” or “will have begun” are not sufficient. B. Failure to meet any of requirements (1) through (3) are considered non-fatal to the NOC: any otherwise valid notice which does not meet one of these requirements will nonetheless be processed (i.e., CIS shall add the substance to the Inventory). However, one or more of the following actions shall be taken: 1. If requirement (1) is not met, DCO shall notify the submitter by letter or telephone that a specific date of manufacture or import must be provided to EPA within 30 days of manufacture. If no response is received within 30 days of notifying the submitter or if the submitter responds with a date more than 30 days prior to the date EPA originally received the NOC, the case shall be referred to 0CM. 2. If either requirement (2) or (3) is not met, the case shall be referred to 0CM. C. Failure to meet requirement (4) is considered fatal to the NOC: the substance shall not be added to the Inventory. DCO shall send a letter to the submitter notifying him or her that the document received does not constitute a valid NOC, and that an NOC must be received by EPA between one and thirty days after manufacture. If no valid NOC is received within 30 days of sending the letter to the submitter, the case shall be referred to 0CM. ------- Notice of Commencement Chronology and Citations to the Reporting Requirement 1. Section 8(b)(l) of TSCA provides that “(i]n the case of a chemical substance for which a notice is submitted in accordance with section 5, such chemical substance shall be included in such list as of the earliest date (as determined by the Administrator) on which such substance was manufactured or processed in the United States.” Further, [ t]he Administrator shall not include in such list any chemical substance which is manufactured or processed only in small quantities ... solely for the purposes of” research and development. 2. January 10, 1979: EPA publishes proposed PMN/NOC rule. Proposed section 720.52(b) (44 FR 2278; exhibit 1) provides the NOC must be submitted “no later than the day the person first manufactures or imports the substance for a non— exempt commercial purpose.” 3. May 15, 1979, EPA publishes interim policy which includes an HOC reporting requirement. This document refers to the §8(b)(1) language as mandating a statutory reporting requirement (44 FR 28567; exhibit 2). Hence the 5/15/79 requirement is applicable and in force until the revised determination (40 CFR Part 720.120) was made explicitly effective. The 5/15/79 requirement speaks only to subsequent manufacture or import following submission of a PMN. “Any person who submits a (nbc] under this interim policy, and who begins to manufacture or import the new substance for commercial purposes, must submit a notice of this fact to EPA on or about the date when manufacture or import commences so that the Agency can add the substance to the Inventory.” 4. May 13, 1983: EPA publishes final PMN/NOC rule. Section 720.102(b)(l) (48 FR 21753; exhibit 3) provides that if manufacture begins on or after the effective date of this rule, then the HOC must be submitted “on the first day of such manufacture.” 5. September 13, 1983: EPA publishes revised HOC rule with effective date of October 26. 1983 . Section 720.l02(b)(1) (48 FR 41140; exhibit 4) provides that if manufacture begins on or after the effective date of this rule, then the NOC must be submitted “on or no later then 30 calendar days after the first day of such manufacture....” ------- —2— 6. April 22, 1986: EPA publishes non-substantive amendment to the HOC rule to make clear the timing for submission of the HOC. Section 720.102(a) (51 FR 15096; exhibit 5) provides that manufacturers or importers commencing (after PMN review is complete) non-exempt commercial activities of a new chemical substance must submit an NOC on or no later than 30 days after the non-exempt manufacture or import occurs. Quantities of the new substance which have been produced or imported for R&D and will be distributed for non-exempt purposes is not a permissible basis for submission of an NOC. 7. September 14, 1989: Judge Frazier reviews the NOC reporting requirement as it relates to R&D production and distribution prior to the April 22, 1986 federal register notice. See, In the Matter of B. F. Goodrich Company , Docket No. TSCA-89-H-07. ------- WEDNESDAY, JANUARY 10, 1979 PART II E NVI RO NMENW: • PROTECTIOP* TOXIC SUBSTANCES CONTROL Premanufadvre ments andRethw Proced ,à . EXHIBIT I ------- PROPOSED RULES 2278 ure under the Act, including impact on the national economy, small business. technological Innovation, the environ- menL and public health. (e) Procedures for reporting. EPA will notify in writing any person sub- ject to a reporting requirement under this section. The. notification will be sent by certified mail, with return re- ceipt requested. The written notifica- tion will include: — (1) A copy of this § 720.50: (2) A detailed description of the In- formation which is required to be sub- mitted; (3) The name, address. and tele- phone number of the person to whom the information must be submitted; and, (4) The date by which the informs- tion must be submItted, which shall be no sooner than 15 days after the person receives the notification. § 720.51 Requirements for submittal of health and safety studies under § 8(d) of the Act. (a) Appiicabtlity. EPA may use the procedures estabilahed in paragraph (b/ of this section to require any person who has possession of a health and safety study to submit the study, If the Agency believes that the study would assist in the evaluation of the health or environmental effects of the manufacture, processing, distribution In commerm, use, or d j.en ] of a new chemical substance for which the Agency received a px anufacture notice. (b) Prooedwes. EPA wlfl notify In writing any person subject to a re- quirement under this section. The no- tification will be sent by certified mall, with return receipt r uested. The written nod&atton will “de : (1)AcyofthIs 72Iil (2) A description of the requested study; (3) The name, addee, and tele- phone number of the person to whom the study must be submitted; and, (4) The date by which the study must be submitted, which date shall - be no sooner than 11 days after-thE person receives the notifirelton . * 720.52 Nodes .1 ft ’ c i ma.- ufacter. or bapest (a) AppttcabWf p. Any person who commences to manufacture or import for a non-exempt commercial purpose a new chemical substance for which the person previously submitted a pie. manufacture notice under this Part shall submit the notice proscribed by this section. (b) When to repo,t The person must subetit the notice to EPA no later than the day the person first manu- factures or lmporta the substance for a non-exempt commercial purpose. (C) Inforinatzon to be reported, (1) To report a chemical substance, a person shall complete, sign, and submit to EPA a “Notice of Com- mencement of Manufacture or Import.” ThiS form has 0MB No. The notice must include a refer- ence to the relevant premanufacture notice as required by the form instruc- tions. In addition, if the person has as- serted a confidentiality claim under *720.41(b) he must certify that any substantiation previously submitted to the Agency Is materially accurate as of the date of commencement of manu- facture or Import indicated by the notice. 40 CFR Part 720 Pameaxuracrum No’rwzc&nox rca New CH CAL Suuanncm APPenSIX I Sections 5(dX IXB) and (C) of TSCA re- quire persons to submit in their premanu- facture notices all test data in their pease.. slon or control, plus descriptions of any other data which are known to or remen- ably ascertainable by them. Section 720.33 of the Piemanufacture Notification Rules implement these provisions of the Act. to particular, I 720.33(cXl) provides that per. sons need not submit data that .ppcar ix periodicals which are listed In this Appendix 1. provided they submit st.,i vd Uteatu_re citatioss for the data. The pertodi sls listed are those to which EPA’s Office of Toxic ubV”• . ( ) Immediate sosem on a retula, on-call basis. From time to time EPA Ul emw this liii, primarily to add new lictth us OlSa access to p&”dicais Improves. Areamix 1—Pensoaxcas. Tm sen 1. Accounts of Ch. . ,fri Research, 1815-. present 2. AIr Pollution Control A4.tI.t Jour. nal, 1974-present 3. AmerIcan C”— ” ’ Soolety Journal. 1958-present _ 4. American Indestrial Hyglence Msoclstiqn Journal July 19 19-gemsut 5. AmerIcan 1953-present I. Anslytical Chemistry Journal, 1957-pies- eat 7. Annual Review of Ecology and Siutomat. ice. 1970 VoL l-enI 8. ArchIve. of Environmental C’ ”- don and TO ’ IY . 1972-pramnl 9. Archiv fur Toxicology, 1908-present 10. Archive of l vtronmentaL Resith, 1960- present 11. AP-.c.pherte Environment, an Industrial Journal, 1967-9- ... ..t 13. Bioc’-Pbarmaco logy. i95$- ue.- ent - 12. BrItish Journal of Indu.Utel “ ‘ ‘ 1973-present _ 14. Bulletin of Environmestal don and Toxicology, l- ...I 15. Cancer Research. 1953-piosent II. Chomospbeie W72-pnment 17. CRC Critimi Reviews ix Tox lsolcs*, 18. Ecolcsy,IPTO-prment- 19. Environment Health Peras Uv - 117$- present 20. Environment a -t .s , and Te”etp , 19 17— 5.uL.4 21. Food and Cosmetics Toxicology. 1963- present 22. Health Physics, 1958-present 23. I.A.R.C. Monographs, all volumes 24. InorganIc Chemistry. 1962-present 25. Journal of Agricultural and Food Ch istry. 1953-present 26. Journal of the Fisheries Research Board of Canada. 1972-present 27. Journal of Organic ChemIstry, 1982- present 28. Journal of Pharmacology and Experi- mental Therapeuties. 1969-present 29. Journal of Physical ChemIstry, 1963- present 30. Journal of Physical Chemical Reference Data, 1978-present 31. Mutation Research. 1914-present 32. National Academy of Sciences Proceed- logs, July 1978-present 33. NatIonal Cancer Institute Journal, 1978- present 34. Nature. 1960-present 35. New England Journal of MedicIne, 1969- present 30. PesticIdes Monitoring Journal, 1967- present 37. Residue Review. l9 0 (VoL 3)-present, 38. ScIence. 1950-present 39. Teratology. 1978-present 40. To’$ sy and Applied Pharmacology. DeceseSer 1814-present 41. Water Pollution C oI Federation Journal, 19 10-presset 42. Weed 8”— ”e . iNa-gemant 48. Zeneblotlcu, 1978-present Momma Ov’ ’- von Peo. em O c lta id w. cmexc*i lidasramp ft. Pumeaavp*crun Novsercuioa ‘,. I. M ROUID LID ena ,css u. seals amo&ca -. In aaas i svisTaiic IT. 55 $ CAI. 5VIflLI V. JT5T TfliO TID 051 OP LSDRTZOPAL This as .lrvffiefl$ contains gu*” for ore-’ sting psupo..4 ewusic n. for chemical su t .s’ whom identities are “—d eon- fidential for purposes of EPA’s Presnadulso.’ ture NoU r l’Prcoram The.. guidelInes an amended veeslcn of r’ ”ws Which EPA first made’ available In AprIl, 1817, to saint who claimed edf I c chemimi Identity confidential for pwp. of tb Ch.seIseI Sebatome Inventory. The Agency has caedifled them to conform to the pro-. manufacture notIfication rules. These pro- posed rules would require persons who claim confidentIality 11th rmpect to apesihfe identity t foU .lo these 5 n4.i.iiv., . In ersating a - , g-—’4 generic name. EPA solicits ec” ’ta concerning the app11ca . . ity of these g” ’ ix Implementing the confidendel “ W y requirements of the premanufacture notification rule.. z, -‘ sen Proposed *720:41’ would require any’ person who cI do. Identity of his new as nm e idssticl to provide a datuUe4, written suppcut the da . to —‘ ‘‘.$be mice wouldre- qufreamh p ani to sebmit a pi’ asd’g neris forth, which “Is only as gs siic r to protect the eonfl dendol ‘ —“Iy of the chemiasi cob.t.noa. M USI$1 VOl. 44, NO 7—W AY, MI IY 14, 1979 ------- Tuesday May 15, 1979 PartV Environmental Protection Agency Toxic Substances Controi initial and Revised inventorles Premanufacturing Notification Requirements and Review Procedures EXHIBIT 2 ------- Federal Register I Vol. 44. No 95 ITuesday May iS. 1979 / Notices 28567 (3) PrtnC:pOI Place of BusinesS Street — city— State (4) Techmco! Contact %ame and Title — cr..i Stats - Telephone Number (5) Parent Company (My company that owns or controls 50% or more of lie submitter’s voting stock). Name Street City State Notice in the “Federal Register 0 Section 5(d)(2) requires EPA to publish In the Federal Register a notice of receipt of each preinanufacture notice within five days of receipt of the premanufacture notice. Subject to I 14. this notice must include an IdentifIcatIon ,f the new substance. a list of uses or intended uses. and a description of :ertetn test data. As a matter of policy. EPA will publish the notice In the manner described in 720.32 of the proposed regulations. In addition, the agency will publish the name of the rubmitting company. unless this information Is claimed confidentiaL Persons should review the Interim confidentiality procedures. below, with regard to EPA’s policy on publication of information which a person considers to b confidential. Notice of Commencement of Manufacture or Import Any person who submits a notice wider this Interim policy, and who begin. to manufacture or import the new substance for commercial purposes. must submit a notice of this fact to EPA on or about the dale when manufacture or Import commences so that the Agency can add the substance to the Inventory. At a minimum this notice must Include the identity of the ,ubstance the premanuuecture document which the Agency previously assigned to the substance in he I 5(dflz) V.dsesl Register notice; and the date upon which manulacture or import commences. There is no’reqwrement that the notice be submitted in any particular form. ft should be addressed to the Document Control Officer. Office of Toxic Substances. at the address indicated above. . - This reporting requirement is imposed under I 8(b) of TSCA. That provision states “In the case of a chemical substance for which a notice is submitted wider Section 5. such chemical substance shall be induded in such list (the Inventory) as of the earliest date (as determined by the Administrator) on which stich substances was manufactured or processed in the Untied States.” EPA believes that a submittal of a notice of commencement is a reasonable method to implement this statutory provision. Cotifidentiality Pending the promulgation of 5 regulations, the assertion and review of confidentiality claims, and the substantive determination of whether information should be disclosed, will be governed by EPA’s general rules for confidentiality of business information submitted under TSCA. 40 CFR 2.301 Section 2.308 incorporales by reference the bulk of the general provisions of 40 CFR Part 2. the Agency. rules for the handling of confidential business information. EPA amended 40 CFR Part 2 on September 8. 1978 (43 FR 39997) and on March 23. 1979 (44 FR 17073). The remainder of this section addresses what EPA believes those provisions require. and how the Agency will implement them. Except as stated to the contrary. EPA will follow the confidentiality procedures of 40 CFR Part 2. The Agency will resolve individual issues not covered by this discussion on a case .by ’case basis. In accordance with 40 CFR I 2.308 and relevant pro isions of TSCA. Until the 5 rules are final and effective, the policy discussed below will apply to all information submitted to EPA wider the premanufacture notification program. After the rules i ii, effective, all such information in the possession of the Agency will be subject to those rules. To the extent that EPA imposes new or different requirements in the rules. EPA will give submitters ample opportunity to update or modify confidentiality claims prior to becoming subject to any new requirements. Cenerol Procedures for Assertirs Confidentiality A person may assert a business confidestiuldy claim for any Information required to be submitted to EPA under TSCA. including any information submitted in the premanufacture notice or the notice of commencement of manufacture or import. In accordance with 40 CFR § 2.203, if a person wishes to assert a business confidentiality claim (or all or part of the information submitted to EPA, he must assert this claim when he submits the information. He must assert this claim in the manner described in 2.203(b) (See below.) The Agency will disclose information covered by such a claim only to the extent, and following the proceduri’c ji t forth in 40 CFR Part 2. Subpart B. If the person does not assert a claim of confidentiality at ‘he time he submits the information. EPA will make the information available to the public without further npttce to the submitter. Section 1.203(b) of EPA’s business confidentiality regulations prescribes the methods for asserting confidentiality claims. Among other things. confidential portions of otherwise non.confidential documents should be clearly identified. EPA strongiy urges the submitter to be as specific as possible in identifying confidential information. Each page of a document should be marked appropriately. In some cases. if non• confidentIal and confidential material are mixed on a single page. item.by.item markings would be appropriate. Section 2.203(b) also states that where a portion of an otherwise non• tonfidentlal document is asserted to be confidentiaL the person may submit separate confidential and non- confidential documents to facilitate identification and handling by EPA. The Agency strongly encourages persons to submit two copies of preinanufacture notices If some o the information is claimed confidential Failure to submit two copies will not affect EPA’s determination of whether confidential treatment is appropriate. Section 5(d)(lli -of TSCA requires the Agency to make non-confidential information in premanufacture notices available to the public. Therefore if a submitter does not file a non.confldential copy. EPA will prepare an excised copy for inclusion in the public file, based upon the submitter’s confidentiality claims. Submitter preparation of the public copy will ease the administrative burden on EPA. and will reduce the remote possibility that EPA will inadvertently disclose information which a submitter claims as confidentiaL Substantiation of Claims for Certain Types of Information U a person asserts a confidentiality claim with respect to the specific chemical identity if a new substance. or for health arid safety data submitted with the notice, EPA will review the confidentiality claim and may immediately make an initial determination of whether the information is entitled to confidenhal treatment. EPA will take this action under I 2.204 even prior to the receipt of a request for release of the information. because the Agency has determined that EPA probably will be requested to disclose the information under the Freedom of Information Act (FOIA). Initiation of the procedures of I 2.204 ------- Filday May 13, 1983 Part Ii Environmental. Protection Agency Premanufacture Notlficatlon Preminufacture NOtice Requirementa and Review Proc.duree Final Rule and Notics Form EXHIBtT 3 ------- I’ p 5 j. j Register I Vol. 4& No. 94 I Fri day. May 13. 1983 I Rules and Regulations 2173 (iii) If the generic name proposed by E PA is acceptable to the submitter. EPA will place that generic name on the public Inventory. (i v) U the generic name proposed by EPA is not acceptable-to the submitter. the submitter must explain in detail why disclosure of that generic name would reveal confidential buainee. information and propose another generic name which a only as generto u necessary to protect the confidential Identity. If EPA does not receive a iveponse from the submitter withIn 30 days after the submitter receives the proposed EPA will place EPA ’. chosen generic name on the public Inventory. If the submitter does provide the information requested. EPA will review the response. If the submitter’s proposed generic name Is 2cceptable. EPA will publish that generic name on the public Inventory. If the submitter’s proposed generic name Is not acceptable. EPA will notify the submitter of EPA. choice of a generic name. Thirty days after this notification. EPA will place the chosen generic name on the public Inventory. 720. C sgsrisserpr::: I. - (a) A person who submits information a EPA undirthis Part on the categories or proposed categories of mu of a new ithemIcal substance may assert a claim of confidentiality for this information. (hi A submitter that asserts such a claim must (1) Report the categories or proposed categorie. of use of the rn..l s ub s ii . (2) Provide. in nonconfidentlal form. a desatptlon of the uses that is only as generic u ne’e,siry to pretest the confl”.”tIaI bn.ni.n Information. The generic use deseription will be liIath .ded in the F.dmuI Rs ss notice desatbed in I 7 L7O. (c) The mi must inhiltif the information required by pstigraph (b) of this section In the specified In the notice form. f 720.50 es fries tI..Jth aid . ...M . I .Th (a) Lrzjb,madon other than so chemical identity. Except as provided in paragraph (b) of this section. EPA will deny any claim of coi fial.ntialIty with respect to Information in hi d In.. health and safety study. ‘ zl.,s the Information would diidoee confidential business Information concernimp (1) Processes used In the manufacture ‘r processing of a ch,”csl substance or ixture. (2) In the case of a mixture, the portion of the mixture comprised by any of the chemical substances in the mixture. (3) lnformaton which is not in any way reLated to ne effects of a substance on human health or the environment. such as the name of the submitting company, cost or other financial data. product development or marketing plane. and advertising plan e. for which the person submits a claim of confidentiality in accorr 4 n’. with I 720.80. (b) Specific chemical identity. (1) Claims applicable to period pilot to commencement of manufacnue. A claim of confidentiality for the period prior to co—’ ’ant of.manufacture or import for the ch.InicaI Identity of a ch aI substance for which a health and safety study was submitted must be asserted In conjunction with a claim . asserted under I 720.85(a). (2) Claims applicable to period after commencement of manufacture or impoa?jbr commercial pwposes. To “ “u1n the confidential status of the th,ffijl!2 1 identity of a ith.m4n.J substance for which a health and safety study was submitted after of manufacture or import . the claim must be reauurted and substantiated in conjunction with a claim under 5720.85(b). In addition to the questions set forth in I 720.85(b)(S )(lv) of this Pert, the submitter must answer the following quesdonai (I) Would disclosure of the ‘ 4 .””caL Identity disclose processes used In the manufacture or processing of a eh. nacel substance or mixture? Desonbe how this would ocme. In responding to the question In I 7m85(bKs)Uv)(A), explain what harmful competitive effects would oc from disclosure of this piu sss Information. - (II) Would disclosure of the thL ni Identity fHaI!bou , the portion of a mixture comprised by any of the substances In the i b’t ,v ? Desatbe how this would x. In respondIng to the quesdon In I 720.85(b)(3)(lv)(A). explain what harmful competitive effects would occur from disclosur, of this information. (U I) Do you assert that disclosur, of the &eh. ,l Identity is not necessary to interpret any of the health and safety studies you have submitted? If so. explain how a less specific Identity would be sn -t to interpret he studies. (c) Denial of confidentiality claim. EPA will deny a claim of c Rd.n 4e1fty for th,mlcal identity under paragraph (b) of this section. nil . . . . (1) The Information would dlsclosó processes used in the manufamurs or proresfiffig of a heiui4 aj substance or (2) In the case of a mixture, the information would disclose the portion of the mixture comprised by any of the substances in the mixture. (3) The specific chemical identity is not necessary to interpret a health and safety study. (d) (Ise of generic names. When EPA discloses a health and safety study containing a specific chemical identity. which the submitter has claimed con ’4m’dal. and If the Agency has not denied the claim under paragraph (C) of this section. EPA will Identify the rka,n4i ’nI substance by the generic name selected under I 720.85, (0MB Control Ne. 207G.4J012) 5720.55 Io Me. All Information submitted with a notice. indiidhig any health and safety study and other supporting documentation, will become part of the public file for that notice, unless such materials are claimed c ”nfldaitiaL In addition, EPA may add material, to th. public file. subIecttoSubpsrtEofth: Pert. Any of the nuncn fi.I.iitial material desatbed above will be aveilahli for public inspection In the Office of Tonic Subs’ ’ e Public Reading Room. Rm. E-1 . 401 M St.. SW.. Washington. DC 20480, durIng normal business hours. of • imioa _ . of ea.......a.....,t of omaifactore or lupat ( a) Applicability . Any person who to manufacture or Import a new ‘ 4 ’ ’cal substance for a commercial purpose for which that person previously submitted a section 5 notice under this Pert must submit. notice dG -’ mqnt of manufacture or Import. (b) When So report (1)Umanufactur, or — for commeiclal purposes begluron or after the effective date of this rule, the mibmittar must submit the ce to EPA on the fir s t day of such msnufactwe or Import. (2)11 manufacture or Import for commercial purposes begin or will begin before the 1TuCttvv date of this rule. the submitter must submit the notice by the effacllv , date of this rule. (ci Information to be repaired The notice must contain the following Informatiom specific th !il. l Identity, premanufacture notice “ umber , and the dare when manufactur, or Import commences. If the person deimed riiniuii..l . eiifity confidential In the ‘ -‘ —it notice, and wants the Ld.nt4ty to be listed on the confldental ------- Federal Register / “°• 48. No. 178 I TtieSddy . September 13, 1983 I Rules and Regulations 41132 CNVJRONUENTAL PROTECTION 1ENCY CFR Pert 720 r 0 p1’S—50002J; TSt4.FRL 241241 premanufacture Notuficat$on Revision of Regulation and Partial Stay of Effectlv Oats AOCNCY’ Environmental ProtectLon Agency (EPA). acilosr Final rule: reVisiOn of regulation and partial stay of effective date . SUMNARr EPA is staying the effective date of fl 720.3(y). 720.36. 720.50(c). and 720.78(b) and issuing nonsubstantive amendments to 720.102 of the final preinanufacture notice (PMN) rule issued under section 5 of the Toxic Substances Control Act (TSCA). Under section 5 of TSCA. any person who intends to manufacture or import a new chemical substance for commercial purposes must notify EPA at least 90 days before manufacture or import begins. EPA Is also clarifying other sections of the rule. o*i’m The effective date of the premanufacture notification rule, with the exception of the stayed sections. *1720.3(y), 720.31720.50(c), and 78 (b), iaOctoberz6, 1983. MThIR 5 5NAUONCO AC1 P. McCarthy. Director. TSCA -rrssiatance Office (TS499J, Office of Toxic Substances. Environmental Protection Agency, Ret. E-543, 401 M St SW.. Washington. DC. 2048t toIl-fies (800-424-goes), in Washington. D.C.: (554-1404). outside the USA: (Operator 202—554—1406), SUPPILMIMTARYflWORN*tlOIC I. Background Under section 5 of TECA. any person who Intends to manufacture or import a new chemical substance for commercial purposes must notify EPA at least 90 days before manufacture or import begins. This requirement has been In effect sInce July 1, 1979. SInce then, EPA has received end reviewed more than 2.500 notices on new substances. EPA has operated the new chemical review program under Interim policies published In the Federal Register of May 15.1979(44 FR 28584). November 7. 1980 [ 45 FR 74378]. and July 2. 1982 (47 FR 28980). EPA proposed a rule to interpret sectionS requirements and to establish notification procedures in the Federal Register of January 10.1979(44 FR 2242). ‘ ns of this rule were reproposed on ‘r 18. 1979 (44 FR 59764). In .n. EPA proposed processor repc ting requirements in the Federal Register of Augi si 15. 1980 [ 45 FR 54842 1 and a clarification of rnporter equiremcnts on September 23. 1980 (45 FR 63806). After reviewing public comments and evaluating its experience in conducting the PMN program. EPA issued a final premanufacture notice rule in the Federal Register of May 13.1982. This rule was scheduled to become effective on July 12. 1983. The rule covers the scope and applicability of section 5 reqwrements; the general procedures for submitting notices; information requirements, including a mandatory notice form: and EPA’s procedures for processing information contained in the notices, including confidential business information. On June 17. 1983. the Chemical Manufacturers Association (CMA) petitioned EPA to stay the effective date of the PMN rule for 90 days to provide EPA time ‘to clarify and modify the rule in several respects. CMA stated that. without clarification and possible modification of certain rule provision., the rule would Impose an undue burden on its member companies. CMA particularly expressed concern about: (1) Tb. research end development (R&D) exemption, (2) the PMN notice f , (3) information requirements on polymer identity. (4) the submission of test data. (5) the submission of data on related rh i d aJs (6) the submission of dedcrlptions of risk assessments. (7) the procedures for declaring PMNs “incomplete,” aid (8) the definition of “possession or control.” In a memorandum accompanying its petition, CMA also raised questions about Information requirements on use and manufacturing operations, the possible release of cosfldai tisl chemical Identity included In health and safety studies,. the tIming of substantiations of confidential chemical Identity, the submission of generic use descrlpllosm. and the timing for submitting notices of commencement of manufacture. In addition, on june 27, 1983, the Society of the Plastics Industry (SPI) submitted a petition to EPA to stay the effective date of the PMN rule. SPI raised two Issues concerning polymer information requirements—the requirements that the average molecular weight and percentage of low molecular weight species be estimated and that monomers and other reactants used at less than 2 percent by weight be identified, In response to these petitions. EPA postponed the effective date of the rule for 80 days. so that it could review the rule language and, where necessary. clarify ambiguous points or revise specific provisions. This postponement was announced in the Federal Register of July 11. 1983 (48 FR 31641). During the postponement period. EPA has received further comments on the issues raised in the CMA and SPI petitions from SPI. CMA. the American Chemical Society. and the National Paint and Coatings Association. The CMA and SPI petition.. as well as these subsequent comments, are included in the public record on the PMN rule. IL Summary of Action hi this notice, EPA announces that the major provisions of the TSCA section 5 Pt .Q4 rule will go into effect on October 28. 1993, In addition. the notice awiounces the followtng’actlons with re ect to the rule: (1) The stay. pending further consideration and rulemaking. of 54729.38 and 729.78 (requirements ceecerning new nh. .nI el substances manufactured under the section 5(b)(3) R&D exemption), I 720.3(y) (the delnitlon of “possession or control”). and * 72010(c) (dat. requirements on related cbmsianl.). and (2)a nensubstantive amendment of I 720.193(bfli) ( tM Ing of submission of the notice of c” csment of menufacture). EPA Ii also clarifying suera) other previsions of the rule (primarily those concerning polymer Information requirements. test data requirements, and Information requirements on risk assessments and uses), and explains why the Agency believes that other provisions Identified as a concern by CMA—such as the mandatory form and incompleteness provisions—do not require revision. accept for the sections that have been stayed, the final rule will go Into effect on October20, i9eS. All PMNs received on or after that date must be submitted - on the PMN form. and notice submitters m comply with the provisions of this nile that are In effect These provisions Incisde all the major notification and premdural requirements of the PMN rule, such as the mandatory form, test data and Information requirements. procedure, by which EPA can declare a notice Incomplete, and confidentiality procedures. With this notice, therefore, the basic provisions of the PPiQI nile will go into effect. These requirements will promote standardized PP.Q4 reporting and iecsrdkeeplng procedures they will allow EPA morti effectively to address the increasing number of PMN. It i . now receiving and they will ensure consistent enforcement of section 5 provisions. The temporary postponement of provisions concernin R&D, “possessIon or control,” and dat. EXHIRIT 4 ------- 41i40 Federal Register I VoL 48. No. 178 I Tuesday. September 13. 1983 1 Rules and Regulations the potential eflects of impurities in the substance. byproducts of manufactire or use. environmental transformation products. iind similar related chemicals. as well as data specifically on the new chemical substance. Al the same time. however. EPA awees that monitoring and exposure data on “related chemicals” need not be submitted. unless these data are directly related to the proposed maniffactine. processing. distribution, uses, or disposal of the substance (e.g.. they wele developed during R&D or test-marketing activities). In revising * flO.50(c) of the rule. EM will solitgt public comments on these issues mid eddies. mom ámctly the exact infotesatla. re ements on related ds cah. In at least one me t , CMA’s concerns oees datarequimaienta for related d ie”isals sines from a miuwidaistendiug of the nile. CMA apparently beliored that the test data themselves, rather than d isalptoas , were reqiiked if Lbs data were unpLIh1 ..1l .k and timi standard literati wore raqtauad for published data. However. I 720.50(c) requires only d.i .w pHa i . of unpublished data n related h nIp 2i (i.e., adssaiptlonof the typeofdata and a sn ’y ofiendts), and It would not have required either published data or literature reference, to published data. These points wm be mad . mars explicitly In any rs.lILiuI of this section. VI. Noauubstaatlve m.&IiauI 5 Section 720.i02(b)(1) of the May rule would have xequized manufacturers or importer, to submit a n8tlce of commencement of manufacture or import “on the first day of such manufacture of lmport. In the memorandum that accompanied its petition. CMA stated that compliance with this pvvv6ion may be very difficult because of “coordination difficulties or the pines of other business.” At the same time. EPA recognizes that, altho s It isimpcrtaaflhst sew chemical substances be entered c i the TSCA s fiM coa . 1 . al mai ’ ’ e (es that subsequent mmafa er. mm keow they are not subject to .V1 requirementa and tc 1 . . t inmecessary EM review oU.pIi tlve PMNs) it makes relatively little differemm whether notification of commercial . nanuIn ?iu the first day of manufacture or shortly thereafter. Therefore. A halieims that cmnpanis..h nIdbe allmii.daome latitude In when they submit notices of comme - t of iwuifactme. and that notices s.hDtad a shari time after manufacture begins should be accepted. At the same time, however. EPA believes that companies should not be allowed to submit notices before m.anufacture begins; only chemical substances actually in commercial production should be added to the TSCA Inventory. For the above reasons. EPA is amending I 720.102(b)(1) to read.: •if maruilacture or import for commercial purposes begins on or alter the effective date of this rule, the subnu er must subout the notice to EPA on. or no later than 30 calendar days after. the first day of such manufacture or import.” This amendment is a.I*tant with several comments received dii ng the public comment period on the proposed P rules. This !1I ltgP is a technical amendment one miner procedaral aspect of this interpretive ride and dies not require further notice and comment. The amendment does not work tithe disadvantage of any PMN submitters, and it does not in any way Impair EPA ’s ability to protect th. public and the environment from chemicol hazards, Further com ant Is unnecessary. As indicated in EPA’s ‘ Inetriactions Manual for Preaamdactair. Notification of New Cboi 1 Smabstancee,” nodes. of commencement of manufacture should be submitted toi Document Control Office., Office of’toxlc Substances (TS498), U.S. Environmental Frotadice Agency. 401 P4 SL SW. Wa Ington. D.C. 20980.’To ensure that notices of are sent to the p .op *dthues ,’EPA is adding this ad4r to the tole as I 720.102(d). V Pubklecord EPA has estabI’. 1 a public record for the PP.Q( rula. . .alrhig (dockt n mher OFFS-s0002L whids Is availa hi. for - inspection in Rin. E-1 , 401 M St. SW. Washington. DC. 30460 from 8 0 a.rs. to 4:00p.m., Monday through Friday. except legal holidays. Persons who do not have access to the public reading room should contact Jach P. McCarthy, Director. TSCA Assistance Office (TS.- 799). at the address given earlier hi this notice. Th. following Information related to thin revision and darølcstlon has been addediothereurrit’ (22) USEPA-O1 “Premanufacture Notificatloit Prsmannfscture Notice Requirements sad evlew Procedures, 48 FR 21722, dated May 13 1183. (21) ChemIcal Maud clu Association ( 4A), ‘‘PetItion for a Stay of the Final Ruleand Notice Form Implementing the Preusamdscturs Noti&aUse iRsqulrsmeiits of the Toxic Substances Control mt , ” dated Fete 17, 1983. (24) SocIety of the Plastics Industry. Inc. ISP !). PetiUen of the Society of the Plastics Industry. Inc. for aStay of the Final Rule and Notice Form Implementing the Premanufacture Notification Requirements of the Toxic Subs tdnces Control Act and a Request That Rule Making Be Reopened.” dated June 27. 1983. (25J USEPA-OTS. Transcript of public seminar on premanufactuze notice requirements, dated June 23, 1983. (26) SPL Letter to M. E. Williams. Acting Director. Office of Toxic Substances, dated July V.1983. (27) National Paint and Coatings Association. Letter tot. DeSantls, Office of Toxic Substance., dated July 28. 1983. (28) American Chemical Society (ACS). Letter to D. It. Clay. Acting Assistant Admirastralor. Office of Pesticides and Toxic SubeLc . , . . , dated July 28, 1963. (29) CMA. Letter to D. R. Clay. Acting Assistance Administrator, Office of Pesticides and Toxic Substances, dated July 29,1983. (30) alA, Letter toO. It. aay. Acting Assistance Administrator. Office of Pesticide. and Toxic Substhn , ,., dated August17. 1983 (15 USC. 2905) IMI of Subjects I i 40 RPaI9 28 micsis, L.i. — tul disst . Piemanthetess nod1k Henardesm matedaL sad requlsemeata. Datedi SepL,.b.8 . 1185. WIllbmftV . t” — Admmnistmtcj ’. PART 728 .—(AMEIIDEDI Therefore. 40 CFR Put 729 Is amended as followsi H 72O. 7*36w 720.50, aid 730.7$ ( ewJs4I i.Th. effective date of * 17 2 9.3(y). 720.36,720.50(c), and 720.78(b) is hereby stayed until further notice. L1n 1720.102 ph(bllhJls revised and (d) Is added to read as followm I 720.103 N &s ot cmma.,.....wti of • • I I • (bJ I4lten SozeporL (1) If manufacture or import for commercial purposes begins on or alter the effective date of this rule. the submitter must submit the notice to EPA on. or no later thea 30 calendar day., after the first day of such manufactuss or Import. (d] lilsele to ;ubmit, Notices of c’ ” ncement of manufacture or Import should be submitted tm Document Control Officer. Office of Toxic Substances (TS-793). U.S. Environmental Protection Agency, 4 M St.. SW., Washington. DC 20460. ire o. o-wsi Fihd e.ia.o . s .mj cam ------- iMQO Federil Resist I Vol. 51. No. 77 / Tuesday. April 22. 1988 I Rules and Re Iauon , documa8 thaw own activitia. They are oct ,,qoged by this rile to mamtain records d uBn1 what — mu of an R&D maba’ aIW tbw asu activities iri COPISI aid they so lon et have cannel .1 the abstance. The pinvimon that miMfectw, retain specific record. whes an R&D substanc. is distributed to other pereons does nos apply if the substance is i tcorpcnted into an crude or exists in a (inai product as an impurity. If an R&D substance produced at more than 100 kg per year is incorporated into articles in the course oF R&D or is included na product as an unpw,ty. manufactwsn must record the duposition of the substance in the article or the final product aauming the substance is produced at more than 100 kg per year). but they ate not specifically required to document the disposition of the aiticlee or products themselves. or the names and adthsss.. of the pureess to whom they as. distributed. In addition. the specific quantities involved an sot subject to the notification r.qwrements. of 720.311c1(2 ). Beyond the specific records required by the rule. manulacninrs aid importers who conclude hey are exempt from P? IC4 requirements fore chemical substance seed for purposes of R&D should be prepared to justify the nature and scope of he iracttvtdes WA notes here that. althmiaji the ftnal rule does - not requ Ire manidacturer, and Importers - of R&D substance, to maintain record. demonstrating that their activities constitute legitimate R&D. the burden of proving eligibility for the R&D exemption. as for any specific exemption from an otherwise applicable general statutory requirement rests with the person claiming the exemption. WA advises manufacturers and Importer, of R&D substances to be prepared to meet this responsibility should a qa.rstien arise concerning their compliance with the general requirements for PIC4 or the exemption for R&D. 8. Data on Rufated C 5omicai. EPA has reexa d the pnpiiud requirement In I ? .*s) pub 1 K 1 to he Fedeisi 1e situ : .1 27.1988(88 FR & that emeom submitting a 4 suu e the A with unpublished date en the ‘echh and environmental effects of thio.k. such as byproducts and faede’ rk& which are relatid In the cases of pes il 1 to the new ‘ micaI substance which ta the focus of the QI. While 1n $(d$1) (B) and(C) of1 CAgents EPA broad authoulty to require ash data, WA finds that It Is neceemey to exercise this au*cVdy to the ems of every new chemical aubst For most review, of new substances, published data on the health and environmental effects of related substances and data submitted under section e) will su ce to enable EPA to evaluate risks. Should the Agency determine that data on elated chemicals are es.ential to its review of a particular w chemical substance, it will request the additional data from the submitter, a procedure recommended by the Chemical Manufacturers Association (CMA). (a a comment on the proposed rule. CMA wrote that in the event EPA required unpublished data on related chemicals. EPA could ask the P 4 submitter to search for he data the Agency needed to complete its review. If such data are available, the P%C4 submitter could provide them to WA on request.’ This approach will provide a flexible method of secwlng information n.e ary to conduct premanulacture reviews. Accordingly. the requirements off Tso.50(cI have bees deleted. WA points out. however, that It Is In the interest of submitters to provide the Agsncy .wuth a full descrtpftcn of .11 available data relevant to a itch assessment of the chemical substance that is the focus of the P! C4. Failure to provide this Information, white It Is Important to assessing Isk. may unnecessarily delay review of the PI .Q& potentially leadIng to extension of the review petted and possible action. EPA also reminds sisnufeciwir, and importers that existing provisions of the C4 tile still require them to submit certain information about related chemicals. Under I 7 .4I of the 4 rule. pasa aph (b) requires reporting of the identity and volume of Impwtaeu , and parugreph (d) requires deamiptions of bypsoducts roe.lttng from the . u. ufacture . pioceesuig. and i.e of the new chemical substance. In addition. section e) of TSCA requires ____ manefahiu ere and Imports ,, to provide EPA with any tnloruiatios which they obtain which . mp ite the conchislos that a substance or mixture pies..nts a substantial risk to health or the environment. C Pouiu ion or Control —‘ — 34b)(1)(BJ of TSCA and I 7a50 of the P144 nile require_____ manefaai. .... and Impmlors to .U health aid environmental . .ffacts test data on the now Ia .udal substance in ir ‘pasesslen or . . .ts.L ” In addition. I 7 JS(bK1$l) rs ms manulaeasuie or apart., of R&D subs’ua” to evabmte metM Informati o n is their pe u or to meet requli sts for the exp heMD.EPAbasmed.a slight change in the langeege of I 720.3(y) from lie proposed rule clarify that data in a manufacturers or Importer’s poeeession or control include data In thefilee of its agents who are engaged us R&D. test marketing or commercial marketing of the substance to the extent that th. files are kept in that persas’s capacity as an agent. EPA considers thea selected rnips of individuals. who work under contract or special anangemern for a manufacturer or importer on a specific project, to be under that company s control for the scope of the prouect. Companies must request that the Ales of ths qencs engaged in such work be searched for daip en health and enviroiunernal sffscts relevant to the activities hey are under contract to pursue. EPA also includes within the scope of data tn “possession or control” the files of persons engaged in research. development, test marketing or commercial marketing of a new pk. Ii I substance, and who are employed by companies associated with the submitter of the P? 1 but which are located outside the United Slates. inlets the laws of the foruige nation forbid such a search. fl *O,ly Cit anicoI• Simian U(s) of TSCA exempts from P?.Q 4 sew chemical substances which are manufactured or processed for export only and will not be uied in the U.S. The proposed revision off 720 3 (31 would have limited processing to activities occurring under the control of the maeuhcnirsr or importer In this final nile. WA modifies the defuut:ori of the term “manufacture solely for export’ to Include processing which is not under the direct control of a manufacturer or Impertu.aslonguitocctin solely for expest. (The nib avss.efsrences the definition of ‘process solely for export in 40 R 721.3.) However. the “ “ ctu,or must know. by means uf a contract or same other evidence, that the processing is occurring for export only. For substances to qualdy as expoet.only chemicals. their processir.g must ales be limited to activities wnLcn do not involve use. For example. formulating a mixture constitutes a legi te form of processing for export. oily ‘ 4’ i” but their use as Intermediates in chemical production dose sot. i 1 .oIIoe of Commencement of Marwfe ir, As diuuud earlier in this notice. EPA allows a manufacturer or importer to use R&D wmial far twn ’R&D cosslal purposse only alter .o.plsdas of the PIiDI review period. Exhibit 5 ------- F.d&sl / Vol. SI. No. 77 / Tuesday. Apr 11 22. 1016 / Rules and Reg 1ati 3 except as ds.atbed in $72100 (d) and (I). EPA hu received querIes about the timing of iotiSc*tic of commeucement of manufacture in cuss whir, P%*I review has been . .uw,latsL but the ‘namdactig,r intends to begin non• exempt commercial activiltes with quantitIes of he new disiwcal substance previously produced for purposes of R&D. EPA requires persons to submit a notification of commencement of manufactur, within thiny days of the stan of non.exempt commercial manufacture of a new substance. If amounts of the new chemical produced for R&D already emit. a manufsuiwer or importar may use them for non.exumpt commercial purposes as soon as the PMN review is complete, but that person may not submit a aotiftcation of commeuc nt of manufacture until actual non ..xempt manufacture begins. Section 721102(a) hu been revised to reflect this. In addition. even after the PMN review period ends the new substance may be muufactured solely for R&D or solely for expmt. In that the manufacturer or Importer. • submit a. notice of - ..i • . .. non . mpt manufacture occers. IlL Ru — -’g lacoed EPA has established a recuti for this rulemaking ( dnek.t number OPTS- 5W71j . which Is available for inspection in Rio. S-107. 401 M St.. SW. Washington. DC 20460 . hems sm. to 4 p.m. Monday through Friday, except legal holidays. Persons wh . do not have access to the record In the public reading room should contact Edward A. Klein. Director. TSCA Assistance O s ( ‘TS-799J. a: the above address for assistenno. The record includes Information PA considered in developing this .u1s The record Includes: 1. This notice and P 4 doc’tr iiti cited In this notice, 2. Public comm*. 3, 9uiui ,i. 4s, of meetings with tsad. associations, public lateNt sqs, and other coups. 4. di ac 5. Survey of research and development activities cgs ’i.c’ ed by chemical Rims s All communications b.t a PA and persons outside the Agency per•”” igtothsdevelepmensdths rule. 7. A document responding to public comments. IV. Regulatory A:t A. £recutive Ordu i i Und Executive Order 12201. EPA must determine whether a title is “mapoV’ and therefore requires a Regulatory bnpacz Analysis. EPA ha. determined that this tithe Is not major because it would not have an effect of $100 million or more on the economy. The u ale will not have a sigzu8cant effect on compstttion. costs. or prices. EPA submitted this nile to the Officeof Management and Budget (Ohs) for review as required by Piticutive Order 12291. 9. Ragulotoay Raxfb,Ifty Ad As reqtWed by the Regulatory flexibility Act (S U.S .C. 506(b)), EPA has assessed the impact of this rule on small businesses. EPA has determined hat once the rule .L1i g involve, relatively minor revisions to the Bual PIiQJ rule, it will not oreate additional Impacts on small bosinsiss over those already idenNted I nthsflm lMlguIs.4IFR 21722. C Pqparwork RMiction Mt The information provisions In this title are a best of the InA ismatios collection reqiate..’ut . of lbs C4 rule, which has already bees cleared by OhS un the Papsiwork Redaction Ace 01 1110.44 U.S.C. 3001.5 seq. OhS oss ol number is ZWO .gOl& r Ical& Eavli tal protection. Premanufacture notification, Hwidons materials, R.cordkespsng and reporting requirements. Dated: AptI 7. tIN. IasM.P—--i. PART 720—4A151DJ Thsefo . 40 ai Part 720 15 amendsd’u follows: I. The authority citation far Part 7201$ revised to read an follows: A Ily 1$ USC. 2505 0I . and MS. 2. In $7213. paisç.phs (5) and (y) are revised to read u fellows: iim 0 t 1JU • • • I I S (s) Manufactu, solely for upcst means to manufactwu or Impart for commercial p rpoeee a substance solely for ,art from the United States under the foU .wlag restrictions on activities In the Ulaltsd States: (1) DIstrIbutIon In commerce Is limited to puiposes of export or pro’ ‘i solelyforIxrtasde , in * 72fl of this chapter. (2) The iufacturer or tmporta - any person to whom the substa 1 distributed for pwpoee. of expc’ processing solely for export (as a nrt in I 721.3 of this chapter). may not use the substance except In small quantities solely for research and development ui accordance with * 720.35. • I I I I (y) ‘Possession or control” means in possession or control of the submiuer. or of any subsidiary. paruiership in which the submitter is a general partner parent company, or any compaay or paruiership which the parent compeny owns or counols. if the subsidiary. parent company. or other conipmy or paruiership is associated with the submitter at the research, deveiopmen,. t marketing, or commercial marketing of the rhemical substance in question. (A parent company owns or controls another company if the pm-ens ewns or couar 1 la 00 psr eot more of the other company’s voting stock. A parent ‘ wpaiy owns c i coonolo any parmuislep m which it Is a general partoer). information Is included witha this definition d It Is: (I) In lies maIntained by mibnutier’s employees who arm (I) Associated with research. dsvslepioeat. test marketing. or commercial marketing of the che substance In question. ( ii) Rasonably likely to have su i— data. (2) MaintaIned in the files of ocher agents of the submitter who are associated with research. deveIopmeri . test marketing. or commercial marketing of the h.micaI substance in quest:on in the course of their employment as sucri agents. • S S I 3. Ia I 72130. paraçaph (a) ii revised and pat sph (I) is added to reed as follows: * hISS CB.,,&..,. let suh$ ect te nituL-Di mqi$smaate • . I S I (e) Any new chemical substance manufactured solely for export ,f. whe i the substance is disutbuted in (I) The substance Is labeled in accordance with section 12(a )(1J(BJ of the Act. (2) The manufacturer knows that the person to whom the substance is being distributed Intds to export it or pru oss it solely for export as defined ri * 725.3 of this chapter. • I S S I ------- Fud.nl Raçst.r / VoL. 51. No. / Tii ay. Aprü 22. 1911 I Rules and Requlatior., l5 f 3 (iv) The names and adési sot any persons othir than the anfactwer or importe, to wbo the substance is distitbuted. the idsn ty of thu substance to the extant koow the amount distitbuted, and copies of the not*Acatjo s required under I 7 20.3 1(c)(2). These records are not required when substance. are distributed as impurities or incorporated into an article. in accordance with parapapk (d) of this section. (2) A person who manufactures or imports a chemical substanc, under I 720.31 and who manufactures or imports the substance in quantities pester than 100 küopsms per year must retain records of the idendty of the substanc, to the extent known. the production volume of the substinc ,. and he persons disposition of the substance. The person is not required to meintarn records of the disposition of products containin$ the substance as an unpustty or of articles incorporating lie substances. (3).Records under this parspeph must bst fIined for $ years after they are developed. • • S S 7. La 720.102. parapaph (a) ii revised to read as followL f 7*111 . of csrenanssm.n of FseWs er U’upafl . (a) Applicability. Any person who commences he manufacture or import of a new chemical substance for a nonexsmpt commercial purpose for which that person previously submitted a section 3(a) nottce under this Part must submit a notice of commencement of manufacture or import. • S • • • (FR Dec. 554525 Fd.d 4—Z14 5 543 sin) cow ------- I ------- Existing Chemical Assessment Division TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals What Are Significant New Use Rules? Section 5(a)(2) of the Toxic Substances Control Act (TSCA) allows EPA to designate, through a rulemaking process. some or all uses of a chemical substance as “significant new uses.” Such rules are known as Significant New Use Rules (SNURs). Subsequently, persons who intend to manufacture, import, or process such substances for a significant new use must notify EPA at least 90 days before commencing that activity. The Office of Toxic Substances (01’S) evaluates such notices and can, if necessary, take immediate action to prevent or modify the intended activity. How Can SNURS Be Used to Control Health and Environmental Risks? In cases where EPA believes a substance may be hazardous to human health or the environment, and the uses identified may result in significant exposure, Section 5(a)(2) directs EPA to evaluate the intended use(s), and monitor the potential exposure and risk. If necessary, EPA can prohibit or limit that activity until adequate data have been developed and evaluated to determine health and environmental risks. Where unreasonable risks are found, EPA may take immediately effective control action to prevent such risks. For further information regarding TSCA Section 5(a)(2), please contact: Frank Kover Chief, Chemical Screening Branch TS-778 U.S. Environmental Protection Agency 401 M S;reet, SW Washington, DC 20460 Telephone: (202) 382-3436 U.S. Environmental Protection Agency Office of Toxic Substances 9/88 ------- M ------- Agency Wasn,ngtori D.C. 20460 Toxic Substances EPA The Toxic Substances Control Act Public Law 94-469 Reporting for t Cheniic I Substance Inventory Instructions For Reporting for the Revised Inventory ------- Reporting for d ii Partial Updat g of tis Date B s TSCA ‘p- ------- Answers to Your Questions About the TSCA Section 8(c) Rule 0 Of lice of Toxic Subst6nces Environmental Protection Aqency ------- Teuc 3 ”c.s D.C. o mmbef t9$$ 1’o ,c SubiCis NEW CHEMICAL INFORMATION BULLETIN Exemptions for Research and Development and Test Marketing ------- Mc ------- TSCA CBI CLEARANCE SUPPORT FOR TSCA ADMINISTRATIVE ACTIONS SEP 7 I9 39 CBI CM CLEARED REGION CLEARED REGIONAL HEARING CLERK DOCUMENT CONTROL OFFICER(S) COURT REPORTER NO Mariana Browning Dickinson James P. Owens, ii:i No EPA Region I J.F. Kennedy Federal Bldg. Boston, MA 02203 FTS 835-3451 II NO Karen Maples Garcia Abrines .No EPA Region II 26 Federal Plaza New York, N.Y. 10278 FTS 264-9881 III YES Suzanne Canning Douglas White, Atty No EPA Region III Ed Cohen 841 Chestnut Building Philadelphia, PA 19107 FTS 597-8913 IV YES Marsha Dryden Bob Stryker No EPA Region IV 345 Courtland Street, N.E. Atlanta, GA 30365 FTS 257-2681 or 257-8913 V YES Beverly Shorty Beverly Shorty No EPA Region V 230 South Dearborn Street Chicago, ILL 66064 FTS 353-1669 ------- TSCA CLEARANCE crp SUPPORT FOR TS DMINISTRATIVE ACTIONS CBI CBI CLEARED REGION CLEARED NAME DOCUMENT CONTROL OFFICER(S) COURT REPORTER VI YES Carmen A. Lopez John A. West No EPA Region VI 1445 Ross Avenue Dallas, TX 75202-2733 FTS 255—2115 VII YES Linda McKenzie Gary Bertram No EPA Region VII 726 Minnesota Ave Kansas City, KS 66101 FTS 757-2853 VIII YES Joanne McKinstry Kathy Diclementi No EPA Region VIII 999 18th Street Denver, CO 80202-2413 FTS 564—7592 IX NO David Carison Robert Peterson No EPA Region IX 215 Fremont Street San Francisco, CA 94105 FTS 454-8600 YES Marian Atkinson Jonathan Heller No EPA Region X 1200 Sixth Avenue Seattle, WA 98101 FTS 399-1078 ------- sPip UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINJGTON. DC 20460 4P4 , nfl w-r rr rcnrIpr AUfl 1 6 1 (139 MEMORANDUM SUBJECT: Availability of Miller Reporting Company, Access to TSCA CBI /,/• /..“ FROM: Linda A. Travers, Director q, ’?/4 /“ Information Management Division 17 Office of Toxic Substances (TS—793) TO: Frederick Stiehl Assistant Enforcement Counsel Toxics Litigation Division (LE-134P) This memo is to inform you that the TSCA access available to Miller Reporting Company has been revised to allow Miller to work under all sections of TSCA, and any in program area. Previously, Miller had been cleared for all sections of TSCA, but only for cases involving biotechnology. Miller Reporting is constrained to performing transcription work in a secured area at EPA headquarters. Offices using their services must provide appropriate space as required in the TSCA CBI Security Manual. All applicable TSCA security requirements must be adhered to when using Miller Reporting Company services. A copy of the Federal Register notice is attached for your information. Attachment ------- Federal Register I Vol. 54, No.128 / Thursday. July 8. 1989 1 Notices 284? Lu pay are set forth under Appendix A of the filing. Texas Eastern also submits for filing us a part of its FERC Gas Tariff. Fifth Revised Volume No.1. six copies of the following tanff sheets: Substitute Sixth Revised Sheet No 72. Substitute Sixth Revised Sheet No. 74. These sheets are being filed to correct a typographical error in a fihng made by Texas Eastern on Apnl 21. 1989 in Docket Na. RP8O—150-000. The tariff sheets filed Apnl 21 inadvertently set forth incorrect .illocation factors for Carnegie Natural Cds Company and Midwest Natural Cas Company. The woikpapcrs under Attachment A of the April 21 Iilrng set forth the correct allocation factors, which the above listed sheets reflect. The monthly principal amounts do not change. Texas Eastern requests that the Commission permit the tariff sheets to become effective May 1. 1989. Copies of the filing were served on Texas Eastern’s junsdictional customers and iuiterested state commissions. (upies of the filing were served on Texas Eastern’s jurisdictional customers and interested t te commissions. Any person desiring to protest said filing huuld file a protest with the F derel Energy Regulatory commission. U 5 Ninth Capitol Street. NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Coniiiiissiun’g Rules of Practice and Procedure. All such protests should be filed on or before July 7, 1989. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Parsons that are already parties to this pioct’ading need not File a motion to intervene Copies of this tiling are on file with the Coniinission and are available br publu inspection Luis El Casnrll. .SeLn ’tnry ll’k Dub. li —I5U05 Filed 7— 9, 8.45 cm l biLLiNG CQDE.67I7.Oi.. ENVIRONMENTAL PROTECTION AGENCY IOPTS- 140116; FRL-3611—5 1 Access to Confidential Business Information by Miller Reporting Company AGENCY: Environmental Pro!eLiiun Agi. ’iicy (EPA). ACTION: Notice. Washington. DC. access to information which has been subiniu ’d to F.P.\ wider all sections ol the l’cjxtc Su i ...iices Control Act (TSCA). Some of tie information may be claimed or determined to be confidential business information (C I I I ). FOR FURTHER INFORMATION CONTACT’. Michael M. Stahl, Director. TSCA Assistance Office (TS—799). Office of Toxic Substances. Environmental Protection Agency, Rm. EB—44, 401 M St.. SW., Washington. DC 20460. (202) 554— 1404, TOO: (202) 554—0551. SUPPLEMENTARY INFORMATION Under a procurement. MRC. 507 C St.. NE.. Washington, DC will assist the Office of Toxic Substances, the Office of the Administrative Law Judges. and the Office of Enforcement and Compliance Monitoring in providing reporting services for administrative hearings that will require the review of information that may be claimed or determined to be C I II. EPA is issuing this notice to inform all submitters of information under all sections of TSCA that EPA may provide MRC access to these C DI materials on a need.to-know basis. Authorization for access by MRC to TSCA CIII, under this procurement was previously announced in the Federal Register on August 25, 1988 (53 FR 32442). All access to TSCA C DI under this procurement will take place at EPA Headquarters facilities. Clearance For access to TSCA C LII under this procurement is scheduled to expire on July 14, 1990. MRC personnel will be uequired to sign non.disclosure agreements and will be biiefed on appropriate security procedures before they are permitted access to TSCA Clii. Dated June 23. 1989. Linda A. Travers, I),rrt.u,:. IszJ.ar::uit,ins .‘ lu,li. .. ’,’i., ’iii ! Ji I I1Ii? i.’ vi lu’,,. .SO1I.t( isi IFK Doc aii—isatja Fikd 7-5—aq a 4S a,ii ai uaG CODE essa-so-is I OPTS—S 1734; FRL—36 11—71 Toxic and Hazardous Substances; Certain Chemicals Premanufacture Notices AGENCY: Environmental Protem twn /ageiic.y (EPA). ACTION: Notice. SUMMARY: Secton 5(afll) of the Toxic Substances Control Act (TSCA) requires any pei on who intends to manuf.ictuie or import a new chenucal substance to — submit a prcmanufacturc notic.e (PMN) to EPA to lc,tst 110 days tniorc tii.uciuf.iu:tui i’ or import cunirnrnri’s St.ttutory ru uirt’r:t i’ t’ f.ir .tction I ‘ i . , Li.. Fudcral k gistec of M a) U. LIJoJ 21722). This notice announces receipt ut 105 such PMNs and provides a sumin.iry of each. Dams: Close of Review P rzuds P 89—681—August 2. 1989 P 89—692—July 30. 1989. P 89-693. 89-694. 89-695. 89—t io. 1 19— 697, 89-698, 89—609. 89—700.89—701— August 5. 1989. P 89—702—August 6. 19th ). P 89—703—July 21, 1989. P 89—704. 89—705—-August 6, I ’J89. P 89-707—August 7, 1989. P89-708.89-709.89—710. 89-711, 119- 712. 89—713. 89—714,89—715. 89—716—- August 9. 1989. P89—717.89—718,89—719. 89-720, 119- 721. 89—722. 89—723. 89—724. 89-725— August 13. 1989. P89-726. 89—727. 89—728——August 14. 1989. P 89—729, 89—730—August 15. 1989. P 89-731, 89-732, 89—733. 89—734. 89’- 735—August 16. 1989. P 89—736—August 9, 111119. P89—737. 89—738. 89—739. 89—740. 89— 741, 89-742—August 19. 1989. P 89—743. 89—744. 89—745. 89—740 41i 747. 89—749——August 20. 1989. P89-750-August 21. 1989. P 69—751, 89—752, 89—753-—A ugu’ 1989. P 89—754. 89—755. 89-756. 89—757. 89— 758, 89-759. 89—760. 89—761—Augusi 23. 1989. P89—702. 89-763, 89—764—Aiigusi 27. 1989. P 89-765. 89—766. 89—767. 89—768—— August 28. 1989. P 69-769. 89—770—Auj. usI 29. 1989 P 119—771. 89-772, 89—773—August ‘JO. 11.1811. P 09—774 89-775. 89—770—St’ 1 iii ’,iuliii 2. 1989. P 89-777, 89—778.119—779, 89—7110. 89— 781, 89—782. 89—783. 89—7114—S’pli’tiilii’r 3 11.8.19. P 89—785. 89-786. 89-787. 89—71 18-— Septcitubei 4. 1981) P 89—709—Sepleriiber 3. 1989 P89—790——August 23. 11.11*) P 119—7111—Septenibvr 4. 1Wi11 P 89—7112. 119—793. I19—7114—Si’plrnilui r 5. 1989. P Li11—79t Septeniber 6. 111)19 P 89-797—September 9. 11189. P O9-7’Jli—SrptemLicr 11) 19)19 bJ” P1i9—691—July3. 1989 P89—692—June 30. 1989 p 89—693. 89—4194, 1J9—(j ’15 )i1I—( ’ ) 11” (.17. 8’)—698 ift)-.4,9’t fl9 7()() iI!i—’(iL 6, 1’)Il’I SUMMARy: EPA has auiharizu.d Muller l(i:iniri uig Company (MRC). ------- UNITED STATES ENVIRONMENTAL PROTECTION AGEN V WASHINGTON. D.C. 20460 August 22, 1989 OFFICE OF ________________ THE ADMINISTRATOR TO: Mr. Michael Woods, Director Compliance Division FROM; Mrs. Bessie L. Hammiel Document Control Officer Office of Administrative Law Judges SUBJECT: Handling of Confidential Business Information Pursuant to TSCA Section 16 (a) and the Administrative Procedure Act (5 U.S.C. 552, et respondents involved in these cases have a right to file an answer and request a hearing, to contest any material fact contained in their complaint. The regulations also state that the answers are to be filed with the Regional Hearing Clerks. The complaints issued reiterates this and give the mailing addresses for the Regional Hearing Clerks. This doesn’t present any problem unless the answers contain Confidential Business Information (CBI) which some do. The problem is that all the Regional Hearing Clerks donrt have CS! Clearances. There have been occasions where these documents were handled improperly. The Regional Hearing Clerk’s case files are from time to time inspected or viewed by the general public upon request. I think there may be a simple solution to this problem. Maybe when the complaints are written, someplace in the portion that deals with “Opportunity To Request A Hearing” along with the address of the Regional Rearing Clerks give the respondent the address of the Document Control Officer also, and inform them if any part of their answer contains CBI material to forward it to the Document Control Officer and send the Regional Rearing Clerks a sanitized version. Thank you very much for any help you may give us in informing your staff of this procedure or maybe they may come up with a better one. ------- A 1 OL C 1099 Pond ‘Lnt ic jm. M D 21090/(301) 859 49OO TELEX 87625 / FAx (301) 859-4929 September 5, 1989 ‘Vincent Giordano, Evq Toxic. Litigation Division (LE 134P) U.S. Environmental Protection Agency 401 N. Street, S.W. Washington, D.C. 20460 Re: TSCA Co o1aint Dear Mr. Giordano: This letter advises you that David 7. Hayes of Hogan & Harteon will represent Alcolac in connection with the TSCA Complaint that EPA recently filed against the company. Ws would appreciate it if you would provide Mr. Hayss with a copy of the Complaint, aM plea.. do not hesitat. to share confid.ntial busines, information with him insofar as he will be acting a. our counsel on thu matter. ,—Stn sly, Davi 7. Phillips Presid.nt t n t ------- O UNITED STATES ENVIRONMENTAL PROTECTION AGENCY _____ WASHINGTON. D.C. 20460 PMOItW CERTIFIED MAIL RETURN RECEIPT REQUESTED OEC 221988 P STICIOES AND TOXIC $U ITANCU Blake L. Buss, Esq. Jones, Day, Reavis & Pogue 1450 G Street, N.W. Washington, D.C. 20005 RE: 3M Company CDI Claims: Docket No. TSCA-88-H-06 Dear Mr. Bibs: EPA is requesting substantiation of all confidentiality claims that your client, 3M Company, has asserted in the following documents. While EPA is not required by law to present cause for requesting these substantiations, EPA is initiating this process, in connection with the TSCA administrative enforcement action captioned as Docket No. TSCA-H-06, as part of its continuing responsibility to ensure that the Agency is expending its resources protecting as confidential business information (CBI) only that information which actually is CBI. EPA is seeking to reduce the administrative burdens associated with the present enforcement action which result from handling of documents as TSCA CDI, by establishing exactly which information is entitled to CBI protection. The documents covered by this request are: 1. 3M Company; Answer ; Docket No. TSCA 88—H-06; Document Control No. 20—8380163. 2. 3M Company; First Amended Answer ; Docket No. TSCA 88-H-06; Document Control No. 20-8380163. 3. 3M Company; Second Amended Answer ; Docket No. TSCA 88-H-06; Document Control No. 20—8380163. 4. 3M Company, Letter to John J. Nevlari, III, and Attachments (documents and facts concerning import of Y-86-209), dated November 18, 1986; Document Control No. MEN-162-87. 5. 3M Company; Letter to John J. Neylan. III. and Attachments (documents and facts concerning import of Y—86-250), dated November 7, 1986; Document Control No. MEN-293-86. 6. 3M Company; Letter to John 3. Nev].an. III. and Attachments (requesting permission to use Y-86—250), dated September 17, 1986; Document Control No. HEN-293-86. ------- 7. 3M Company; Two Internal Correspondence Memoranda , dated July 30, 1986, and August 1, 1986; Document Control No. HEN—258-88. 8. 3M Company; Letter to Tony Ellis and Attachments (use information on ‘1—86-209 and 1-86-250), dated September 4, 1987; Document Control No. MEN—159-87. 9. 3M Company; Polymer Exemption Notice Y-86—209 ; Document Control No. 55—8600209. 10. 3M Company; Polymer ExemDtion Notice 1-86—250 ; Document Control No. 55—8600250. 11. 3M Company; Bonafide Intent to Manufacture , dated September 11, 1986; Document Control No. 52—8600518. 12. 3M Company; Bonafide Intent to Manufacture , dated July 28, 1986; Document Control No. 52—8600467. 13. 3M Company; Bonafide Intent to Manufacture — Followtrn Letter , dated July 31, 1986; Document Control No. 59—8600627... Pursuant to 40 C.F.R. Part 2, Subpart B, Section 2.204, EPA requests that your client substantiate its claims of confidentiality by submitting detailed written answers in response to the attached questions, incorporated herein by reference. If a question is not applicable to your client’s CBI claims, please so state, and include an explanation. This is 3M Company’s only opportunity to substantiate its claims. Please send 3M Company’s responses to: OTS Document Control Officer (TS-790) U.S. Environmental Protection Agency Office of Toxic Substances 401 M St. S.W. Washington D.C. 20460 ATTN: Donald A. Sadowsky 3M may claim its explanations confidential by marking the response “Confidential”. The answers must be received within (15) business days of your receipt of this letter. Failure to submit the answers within this period will constitute a waiver of the confidentiality claim. EPA may thereafter disclose the information without further notice to you. You may request a time extension by sending the request to the address above within the fifteen day period. If, based upon 3M Company’s response, EPA concludes that the confidentiality is not warranted, the Agency will notify you of its decision thirty (30) days prior to any disclosure. ------- Please use the reference “3M Company CBI Claims - Docket No. TSCA-88-M—06” to identify your correspondence regarding this matter. Remember that any CBI contained in future correspondence must be specifically marked as confidential or you risk its disclosure. If you have any questions, please contact me at (202) 382—3536. Sincerely, Q L 9a44 Donald A. Sadowsky Attorney - Advisor Information Management Division Attachment cc: Ron. Henry B. Frazier, III Administrative Law Judge (A-llO) Jon D. Silberman, Attorney Toxics Litigation Division (LE—134P) ------- N ------- UNITED STATES NVI Q AENTAL OILL.T W A S I it 2fl989 MEMORANDUM SUBJECT: TSCA § 5 and 8 Concurrence Prec,ess FROM: Michael F. Wood, Director Compliance Divisior / Off ice of CompliancbMonitorin 1’ / Michael J. Walker / 1, .& Assistant Enforcei iit Counsels Toxics Litigation Division TO: Addressees The Toxic Substances and Control Act (TSCA) section 5 and 8 program has been returned to Regions I, IV, VI, VII, VIII, IX, and X. During the past four fiscal years, this program was implemented by the National Enforcement and Investigations Center. Although the program has been returned to the these Regions, Headquarters will retain its usual oversight role until these Regions have gained a measurable degree of experience with the statute, regulations, and enforcement response policies. In 1986 and 1988, EPA Headquarters substantially revised the TSCA § . 8,. 12, & 13 and TSCA § 5 Enforcement Response Policies (ER?), respectfully. Both of these ERP5 require the Regions to obtain Headquarters’ concurrence prior to initiating and completing TSCA § 5 and 8 enforcement actions. Attached for your reference are the procedures for requesting Headquarters’ concurrence and for relaxing the ER? concurrence requirements. These procedures establish a process to rapidly respond to your requests. Our ultimate goal is to relax the coflcurrence requirements as soon as each Region gains sufficient experience in the issuance and settlement of cases in accordance with the appropriate ERP. We are committed to working closely with your staff - both technical and legal - to maintain the momentum of this important enforcement program and remain ready to assist you. Please ensure that these procedures are made available to all staff members who are enforcing this important reporting provision. Attachments ------- —2— Addressees: Director, Air Management Division; Region i Director, Environmental Services Division; Regions 2, & 5 DirectOr, Hazardous Waste Management Division; Region 3 Director, Air, Pesticides and Toxic Management Division; RegiOn 4 Director, Air, Pesticides and Toxics Division; Region 6 Director, Air and Toxic Substance Division; Regions 7, 8, & 10 Director, Air Management Division; Region 9 Director, National Enforcement and Investigations Center Regional Counsel; Branch Chiefs and Acting Branch Chiefs: Susan Studlien Region I Wilkie Sawyer Region II Elizabeth Spencer Region III Bill Anderson Region IV Michael Smith Region V Jim Turner Region VI Bob Patrick Region VII Christine Phillips Region VIII Nina Spiegelman Region IX Deborah Hilsman Region X ------- TSCA § 5 & 8 CONCURRENCE PROCEDURES PurDOSe : The purpose of this document is to outline: ].. The procedure for obtaining Headquarters concurrence on Regional Toxic Substances Control Act (TSCA) section 5 and 8 Complaints and Consent Agreements. 2. Headquarters’s and Regional responsibilities. 3. The procedure for obtaining relaxation of these concurrence requirements. Adherence to these procedures will ensure timely concurrence or. Regional complaints and settlement agreements, and relaxation of tnese requirements. Contacts : The Headquarters concurrence process requires an independent review by two Offices, the Office of Compliance Monitoring (0CM) and the Toxics Litigation Division (TLD) of the Office of Enforcement and Compliance Monitoring (OECM). Both of thes3 offices have assigned an individual to act as your regional coordinator. Page 4 of this memo is a current list of )CM’s case support officers and TLD attorneys and their regional responsibilities. Your regional coordinator in the Case Support Branch of 0CM has been designated as the Headquarters contact point for obtaining case concurrences and relaxation of these requirements. All requests for concurrence and relaxation of concurrence must be sent to: U.S. E.P.A. Headquarters Regional Coordinator (e.g., John Foley, region IV) Case Support Branch (EM—342) 401 M. Street, S.W. - - Washington, D.C. 20460 Your regional coordinator is responsible for receiving, tracking, and processing your concurrence requests. Each request for concurrence will be tracked in a database. Following the 0CM case support officer’s review, the concurrence request will be forwarded to the appropriate TLD regional coordinator. In the event you have questions concerning these procedures or the status of a request, you are encouraged to call your 0CM or TLD regional coordinator, as appropriate. During settlement negotiations, Regional personnel should also consult with their appropriate regional coordinators concerning settlement ------- TSCA § 5 & 8 CONCURRENCE JCEDURES ose : The purpose of this document is to outline: j. The procedure for obtaining Headquarters concurrence on Regional Toxic Substances Control Act (TSCA) section 5 and a Complaints and Consent Agreements. 2. Headquarters’s and Regional responsibilities. 3. The procedure for btaining relaxation of these concurrence requirements. Adherence to these procedures will ensure timely concurrence on Regional complaints and settlement agreements, and relaxation of these requirements. Contacts : The Headquarters concurrence process requires an independent review by two Offices, the Office of Compliance Monitoring (0CM) and the Toxics Litigation Division (TLD) of the Office of Enforcement and Compliance Monitoring (OECM). Both of these offices have assigned an individual to act as your regional coordinator. Page 4 of this memo is a current list of OCH’s case support officers and TLD attorneys and their regional responsibilities. Your regional coordinator in the Case Support Branch of 0CM has been designated as the Headquarters contact point for obtaining case concurrences and relaxation of these requirements. All requests for concurrence and relaxation of concurrence must be sent to: U.S. E.P.A. Headquarters Regional Coordinator (e.g., John Foley, region IV) Case Support Branch (EN-342) 401 M. Street, S.W. - - Washington, D.C. 20460 Your regional coordinator is responsible for receiving, tracking, and processing your concurrence requests. Each request for concurrence will be tracked in a database. Following the 0CM case support officer’s review, the concurrence request will be forwarded to the appropriate TLD regional coordinator. In the event you have questions concerning these procedures or the status of a request, you are encouraged to call your 0CM or TLD regional coordinator, as appropriate. During settlement negotiations, Regional personnel should also consult with their appropriate regional coordinators concerning settlement ------- —2— proposals which are not explicitly addressed in the TSCA § 5, 8, 12, & 13 Enforcement Response Policies (ERP). Another important contact for the Regions is Teresa Little in the Compliance Branch of 0CM. Teresa is responsible for servicing the Region’s requests for copies of submitted TSCA 5 & 8 documents and obtaining certified statements. Her mail code is (EN-342), and her telephone number is (8—382-7835). Concurrence Procedures and Responsibilities : 1. All enforcement actions and terms of consent agreements must be submitted to EPA Headquarters, in writing, for review and concurrence prior to filing these documents with the Regional Hearing Clerks. 2. The concurrence request (CR) package must include a. the appropriate concurrence request form, b. the inspection report. c. completed IMD certified statements concerning the Respondent’s TSCA § 5 or 8 reporting status, and (if applicable) the Inventory Status of suspected “new” chemical substances. d. the draft complaint. 3. Failure to supply the items noted above, constitutes an incomplete package and HQ will request resubmission of the CR package. If a package is complete, HQ may contact the Region to discuss additional documentation issues. 4. o Attachment A is a copy of a concurrence request form for the initiation of an enforcement action. o Attachment B is a copy of -a concurrence request form for- concluding an action. o Attachment C is a request for a certified statement. Requests for certified statements must be sent to Teresa Little for processing. She will track your request and send the completed certified statement to the requestor. In order to have a completed certified statement in hand at the time a CR package is being compiled, HQ suggests that a certified statement request should be submitted soon after each inspection which uncovers a potential violation. Depending on the results of the certified.statement, the Regions may need to obtain an updated certified statement at the time the case settles or proceeds to Hearing. ------- —3— 5. The Regional Program Office must have the CR package reviewed and agreed to by Regional counsel prior to its submission to Headquarters. Further the Regional Program Office and Regional Counsel are jointly responsible for ensuring that the alleged violation(s) have been adequately documented. 6. Headquarters will review the Complaints and terms of the Settlement Agreements for their adherence to the TSCA § 5 & 8 Enforcement Response Policy, and the filing requirements of 40 C.F.R. Part 22.14. Headquarters will respond to each request within 28 calendar days from the date of receipt. The 28 day clock does not begin until a complete CR package has been submitted. Resubmission may be required if the CR packaae is incomplete or incorrect . 7. A Region may not file a Complaint or Consent Agreement with the Regional Hearing Clerk until Headquarters has concurred on the filing of the document. Concurrence Relaxation Process : Each Region may request relaxation of the concurrence requirements on an activity-by-activity basis. Once a Region has successfully issued five TSCA § 5 and five TSCA § 8 civil administrative complaints, the Region may request the relaxation of the case issuance concurrence requirement regardless of the settlement status of the cases. A separate request for relaxation of the concurrence requirement for case settlement may be submitted at a later date once any five cases have been successfully settled. An action has been successfully issued or completed when a Region has submitted and filed an action which conformed to the TSCA § 5, and/or 8, 12, & 13 ERP. Requests to relax concurrence for case issuance or settlement should be submitted to the Director of the Compliance Division, 0CM. A sample form memo to request relaxation for either complaint issuance or settlement of TSCA § 5 & 8 cases is provided as attachment D. HQ will process requests for relaxation within 28 calendar days from our receipt. ------- —4— R EG ION. ( TñM1T DflTM ’P( D TELEPHONE # / MAIL CODES Mary McDonnell (OCM/CSB) Marged Harris (TLD) Mary McDonnell (OCM/CSB) Jon Silberinan (TLD) Sanda Spencer (OCM/CSB) Jon Jacobs (TLD) John Foley (OCM/CSB) David Batson (TLD) Tony Ellis (OCM/CSB) Jon Jacobs (TLD) Rose Burgess (OCM/CSB) Marged Harris (TLD) Rose Burgess (OCM/CSB) Vincent Giordano (TLD) John Foley (OCM/CSB) Vincent Giordano (TLD) John Foley (OCM/CSB) Jon Silberinan (TLD) John Foley (OCM/CSB) David Batson (TLD) 382—4818 / EN—342 475—8696 / LE—134P 382—4818 / EN—342 475—8694 / LE—134P 382—4844 / EN—342 475—8689 / LE—134P 382—4119 / EN—342 475—9501. / LE—134P 382—3705 / EN—342 475—8689 / LE—134P 382—4328 / EN—342 475—8696 / LE—134P 1 2 3 4 5 6 7 8 9 10 382—4328 / 475—8693 / 382—4119 / 475—8693 / 382—4119 / 475—8694 / 382—4119 / 475—9501 / EN—342 LE—134P EN— 342 LE—134P EN—342 LE—l34P EN—342 LE—134P ------- TSCA § 5/8 CASE ISSUANCE: SUbmit t form along With the Draft Complaint inspection Report, and Completed Certified Statements Request f or Concurrence -CaseIssuan Respondent: (Name & Address) Regional Contacts Region: 1, 2, 3, 4, s, name and tel. #) 6, 7, 8, 9, 10 Program Office: Telephone #: 8 - Counsel: Telephone #: 8 - Description of Respondent : Respcndent is a: (chemical manufacturer) Date of Inspection: SIC code: Nature of Violation : (Failure to submit a PMN report for 2 chemical substances, substance not subject to TSCA §5(e) or (f) and was distributed to customers; and report for the Inventory Update Rule for 10 chemical substances): Gravity Based Penalty Calculations : ount 1: Hazard Assessment, Major, Level 3, 5 days, $75,000 .ount 2: Hazard Assessment, Significant, Level 3, 25 days, $250,000 Count 3: Significant, Level 1, 10 chemicals, one day only $170,000 Total Prooosed Penalty : $495,000 Issues of National or Precedential Significance: Recommended Action : Concur ____ Nonconcur _____ Concur ____ Nonconcur _____ Date: _______ Date: _______ Reason for nonconcurrence: Reason for nonconcurrence: Michael F. Wood, Director Frederick F. Stiehi Compliance Division Associate Enforcement Counsel Office of Compliance Monitoring for Pesticides and Toxic Substances ATT ACHMENT A ------- TSCA § 5/8 CONSENT AGREEMENTS: Request f or ConcurreJlc se Settlenej despondent: (Name and Address) Docket No.: Filed: / / Regional Contacts Region: 1, 2, 3, 4, 5, (name and tel. #) 6, 7, 8, 9, 10 Program Office: Telephone #: 8 - Counsel: Telephone #: 8 - Gravity—Based Penalty Assessment: Proposed Penalty Reductions : Amount Percentage Rationale Documentation —S —S —S $ % Total Assessed Penalty: Other Settlement Terms : (include actions taken by the Respondent to come into compliance) Recommended Action : Concur ____ Nonconcur _____ Concur ____ Nonconcur _____ Date: - Date: _______ Reason for nonconcurrence: Reason for nonconcurrence: Michael F. Wood, Director Frederick F. Stiehi Compliance Division Associate Enforcement Counsel Office of Compliance Monitoring for Pesticides and Toxic Substances ATTACHMENT B ------- -S., !RON E - — RO c”:,\ A(E. _____ r1 ‘•‘ ‘ 1ORANDUM SUBJECT: Request for TSCA § 8 Certified Statement FROM: Sherry Sterling, Chief Compliance Branch Off ice of Compliance Monitoring (EN-342) TO: Frank Caeser, Chief Confidential Data Branch Information Management Division (TS-793) Attached is a certified statement which will be used as evidence in a Regional Toxic Substances and Control Act (TSCA) § 8 enforcement action. The Facility’s name and address, the calendar year and chemical for which they were required to report has been supplied by the Region. The remaining information is needed from IMD to fully document the violative acts. Please send the completed Certified Statement to Teresa Little, and she will forward it to the appropriate Region. Attachment ATTACHMENT C ------- CERTIFI ED STATEME!f1 i, Linda A. Travers, am the Director of the Information Management Division. The Information Management Division of the office of Toxic Substances is responsible for the receipt of forms submitted pursuant to Section 8 of the Toxic Substances and Control Act. I certify to the following facts: EPA received an EPA Form from the Facility noted below and assigned this submission the Document Control Number listed below. DOCUMENT CONTROL NUMBER: POSTMARI( DATE: FACILITY NAME: FACILITY ADDRESS: CALENDAR YEAR REPORTED: CHEMICAL OR CHEMICAL CATEGORY NAME: Linda A. Travers, Director - Information Management Division Date ATTACHMENT C, PAGE 2 ------- MEMORANDUM SUBJECT: N:D T rEsENVIRoN 1EN _ = Relaxation of Concurrence to Issue and/or Conclude Civil Administrative Actions for violations of Section 5 of the Toxic Substances and Control Act (TSCA) FROM: TO: Region Director Division Michael F. Wood, Director Compliance Division Office of Compliance Monitoring (EN-342) This memorandum is to request the relaxation of the requirement to obtain Headquarters concurrence prior to the issuance (or settlement) of TSCA § 5 civil administrative actions. Region has successfully issued (or settled) the following administrative actions: Complaints Successfully Issued (or Settled) 1. In re: Docket #: i led: TSCA §5 violation(s): 2. In re: Docket #: filed: TSCA §5 violation(s): 3. In re: Docket #:- filed: TSCA §5 violation(s): 4. In re: Docket #: filed: TSCA §5 violation(s): 5. In re: Docket #: filed: TSCA §5 violation(s): Each of these cases was issued (or settled) in conformance with the TSCA section 5 Enforcement Response Policy. Copies of the filed complaints, consent agreements and final orders were forwarded to our 0CM, Case Support Branch, Regional Liaison in accordance with standard operating procedures. If you have any further questions concerning these cases or Region’s TSCA section 5 compliance program, please contact at FTS- . I look forward to receiving your favorable response. ATTACHMENT D ------- V. fo4 A .&.t I ; ., UNITED STATES ENVIRONMENTAL PROTECTION AGENCY _i.. WASHtNGTON. D C 20460 OP’ICE OF PESTICIDES ANO TOXIC SUBSTANCES MEMOPANDUM SUBJECT: OTS/OCM Joint Inspect ion Program Fiscal Year 1988, Second Quarter FROM: A. E. Conroy II, Director Office of Compliance Monitoring (EN-342 TO: Charles L. Elkins, Director Office of Toxic Substances (TS—792) During the past several weeks, staff members from the Office of Compliance Monitoring (0CM) and the Office of Toxic Substances (OTS) have discussed the possiblility of establishing a joint inspection program. The goal of this program is to provide a routine, practical, and “in—context” avenue for 015 personnel and 0CM inspectors to exchange infortnation. The means to accomplish this goal is to get OTS personnel out of the office and into the field with the 0CM inspectors. My understanding of this program is as follows: 0 0CM will target the inspection, determine what particular OTS expertise would be most beneficial for the inspection, lead the inspection, and make the necessary arrangenents for a smooth and efficient inspectional trip. o 0CM will then forward the attached memorandum to the appropriate OTS Division Director for their approval. Once approved, the memo will be forwarded to OTS Office of Program I1anagement and Evaluation. o OTS will provide the funds needed for the OTS employee to accompany the inspector. OTS will fund one inspection trip per quarter per Fiscal Year. Therefore, funding for this program is not required from Divisional or Branch travel accounts. ------- —2- I am enthusiastic about this program and wish to initiate it this nonth. If you approve of the program as outlined above please sign below, return a photocopy of this memo to me, and forward the attached memorandum to Linda Travers. Otherwise, if you have any reservations about this proposed program, please call me to discuss your concerns. I approve of t e joint inspection program outlined above. Charles L. Elkins, Director Offic of Toxic Substances Attachment cc: Janet P. Thompson, Director Office of Program Management & Evaluation Jan L. Lane, Chief Management Staff ------- I 1 o SP4PF UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON. D.C. 20460 OFFICE OF PESTICIDES AND TOXIC SUOSTANCES MEMORANDUM SUBJECT: OTS/OCM Joint Inspection Program Fiscal Year 1988, Second Quarter FROM: Ken Shiroishi, Director Compliance Division / Office of Compliance Monitoring (EN—342) TO: Linda Travers, Director Information Management Division Office of Toxic Substances (TS—793) The Office of Toxic Substances COTS) and the Office of Compliance Monitoring (0CM) have recently agreed to sponsor a joint inspection program. Under this program 0CM will invite, on a quarterly basis, one OTS employee to accompany an 0CM inspector on an inspection trip. OTS has agreed to pay the travel expenses for the OTS employee. The purpose of these special inspections is to provide a routine, practical, and “in—context” avenue for OTS personnel and 0CM inspectors to exchange information. Under this program, the National Enforcement Investigations Center has requested that Mark Scoville accompany Inspector William Palmer to Rhode Island to conduct TSCA inspections of three facilities. The inspection trip will last 5 working days and will begin in either the last week of January or the first week of Feburary. The exact dates will be worked out between Mark Scoville and Bill Palmer. ------- —2— If you approve of this request, please sign below and forward this memo to Jan Lane (OPME). Jan will then coordinate with Mark Scoville to prepare his travel authorization. I approve of the above requested travel for Mark Scoville. Linda Travers, Director Information Management Division cc: Susan Vogt, Deputy Director Office of Toxic Substances Janet P• Thompson, Director Office of Program Management & Evaluation Dean Hill, Chief Pesticides & Toxic Substances Branch National Enforcement Investigations Center - ! ,; i; ’ ,41. // / / ------- i O S7 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 ) 4 PROS’ AUG 5 88 orricE or PESTICIDES AND TOXIC SUSSYANCES MEMORANDUM SUBJECT: TSCA §5 Enforcement Response Policy FROM: Phyllis E. Acting Director - Policy and Grants Division Office of Compliance Monitoring TO: Addressees Attached is the final TSCA §5 Enforcement Response Policy (ERP) which incorporates the comments received on the February 22, 1988 draft. A summary of the comments and the response to those comments are also attached. We appreciate the time and effort spent in reviewing the draft and providing the detailed comments. The final ERP has been revised in the following areas: The policy now addresses all exemption categories found under 40 CFR Part 723. One major change is that failure to notify violations are treated differently . depending on what action the Agency may have taken on the chemical, i.e., chemicals which otherwise qualify for an exemption, versus those which go through PMN review without any con— cerns,and those chemicals which are possible candidates for a TSCA §5(e) or 5(f) action. The circumstance levels for failure to notify violations and commercial use violations have been changed and com- mercial use violations associated with manufacturing are no longer treated as a separate violation when the manu- facturer Is the person who is commercially using the chemical. Exceptions are made when the number of days of manufacture and the number of days of processing or com- mercial use are disproportionate and in lmi inent hazard Si tuations. Genetically altered, naturally occurring and low risk genetically engineered microorganisms are now addressed in the ERP. ------- JUN 8 1989 AMENDED ISCA SECTION 5 ENFORCEMENT RESPONSE POLICY OFFICE OF COMPLIANCE MONITOiUNG OFFICE OF PESTICIDES AND TOXIC SUBSTANCES THE II. S. ENVIRONMENTAL PROTECTION AGENCY ------- —2— The ERP takes into account whether a substance remains at the site of manufacture or leaves the site of manu- facture when determining the circumstances of the yb— 1 ation. A quick reference chart has been included as an attach- ment so that a case preparation officer may, once he/she becomes familiar with the ERP, more quickly determine the penalty associated with a violation. Please be advised that extent determinations are not always based on pounds of chemical substance involved In a violation, and the quick reference does not Include the full dis- cussion on extent. The ERP has been reformatted by placing the Gravity Based Penalty Matrix after the extent section, so that a person using the ERP would determine the nature, circum- stances and extent of a violation and then turn to the matrix to determine the penalty amount. The section on Injunctive Actions has been expanded to clarify when injunctive actions should be considered. If you have any questions concerning the ERP, please address them to David Stangel of my staff at 382—7825. Attachments ------- charles Elkins (TS—792) 5 san Vogt (1S—792) Frederick F. Stiehi (LE-134A) Mark Green od (LE- 132A) A. E. Conroy II (EN—342) Connie Pbsgrove Ken Shiroishi Phyllis Flaherty John J. Neylan III Jerry Stuths Maureen Lyden Ron Carlson Jake Mackenzie Western Regional Ca ipliarice Director I Louis F. Gitto, Director Marvin Rosenstein, Chief Air Ma gei t Division Pesticides & ‘lbxic &ibstarxes Br II Barbara Matzger, Director Ernest Regna, thief aivirorm ital Services Div Pesticides & xic Substaix:es Br III Ste iai R. Wassersug, Director Larry Miller, thief Hazar us Waste Manage t Div lbxic & Pesticides Braixth IV Winston A. &nith, Director Richard DiBose, thief Air, Pest. & ¶D xics Mangt. Div Pesticides & ¶flicic Substaixes Br V William H. Sanders III, Dir Phyllis Reed, thief E ivrorm tal Services Div Pesticides & ¶Lbxic Substaixes Br VI William B. Hathaway, Dir Robert Mir 2iy, Chief Air, Pesticides & lbxic Div Pesticides & xic Substaices Br VII - William A. Sprdtlin, Director Leo Alderman, Chief Air and 1 xics Division Pesticides & Ibxic SubstarEes Br VIII Irwin L. Dickstein, Director Alvin Yorke, Chief Air and ‘Ibxics Division ‘fl xic 9.ibstaixes Braix:h D( Jeffrey Zelickson, Director Davis Bernstein, thief ¶lbxics and Waste Managei z1 Div Pesticides & xics Brazr.h X Gary O’Neal, Director Kenneth Feigner, thief Air and 1 xics Division Pesticides & ‘I xic Substazxes Br cc: Michael Walker (LE—134P) Margaret Rostker (‘15—788) ------- Response to Comments Comment One commenter requested that the definition of Notice of Com- mencement on page 2 of the ERP be amended to read: “Under 40 CFR 720.102, EPA requires that any person who commences the manufacture or importation of a new chemical substance for which that person had previously submitted a PMN, must submit a notice of commencement of manufacture or import on or no later than 30 days after the first day of manufacture or import.” Response The definition has been amended as requested. Comment One commenter requested that the first factor for cal cul ation of the gravity based penalty on page 5 be amended to read: Impact on the Agency’s mandate to evaluate the potential for human health or environmental effects of a new chemical sub- stance prior to its production or Import.” Response The first factor is amended as requested. Comment One commenter requested that on page 7, under Chemical Control Violations, “Commercial use of an illegally produced substance.”, be amended to read: “Commercial use of a substance produced without a PMN or valid exemption.” R is po n s e The ERP has been amended throughout to reflect this change. Comment A number of persons commented on the fact that, not all exemption categories In 40 CFR 723 were addressed in the,ERP. Response The ERP has been amended to address violations of all the exemp- tion categories under 40 CER 723. ------- —2— Comment 0-ne person commented that processing of an illegally produced chemical substance by the company tnat manufactured the sub- stance is almost an Inevitable part of the manufacturing pro- cess and that the previous policy of charging two counts when this occurs Is unfairb Even if the substance never left the manufacturer’s control, the penalty essentially doubles because the manufacturer processes the substance. The commenter sug- gested that the ERP should charge only one count when a man- ufacturer produces and processes an illegally produced sub- stance, namely failure to submit a PMN, but raise the cir- cumstance level when this occurs. Response The policy has been amended to charge only one count when a manufacturer both produces and processes an illegal chemical substance, but raises the circumstance level one level when this occurs. However, there are certain exceptions described in the policy. Comment One person commented that while the policy did address genetic- ally engineered microorganisms, it did not address genetically altered, naturally occurring or low risk categories of organ— I sms. Response The discussion under extent has been amended to address genet- ically altered, naturally occurring or low risk categories of organisms. Comment A -number of commenters asked for examples of how the policy is applied to various fact patterns. Response Appendix 1 has been added to provide the user of the policy with examples of how the policy is to be applied. Comment One person commented that the ERP allows environmental benefi- cial expenses to be deducted from a penalty where the action was requested but not required by EPA, but gives no similar allowance to a company that may undertake the same actions independent of any request by EPA. ------- —3— Response The ERP has been revised to allow credit pursuant to the TSCA Penalty Policy to companies that undertake environmentally beneficial actions. Comment A nMmber of persons commented on the fact that the length of the ERP made it cumbersome to work with when trying to deter- mine a penalty. Response Two revisions have been made to address this comment. First, the ERP has been reformatted by placing the Gravity Based Penalty (GBP) Matrix after the Extent section, so that a per- son using the ERP would determine the nature, circumstances, and extent of the violation and then turn to the GBP matrix to determine the penalty amount. Second, a quick reference chart has been made so that a case preparation officer could use the quick chart to calculate the penalty, after they be- come familar with the revised ERP. Comment A number of persons had questions concerning the definition of certain terms used in the ERP and requested that the ERP contain a definition of these terms. Response A definitions section has been added. Comment One com’menter remarked that the terms “distribution to others,” “further processed for commercial use by the company, “further processed by another firm,” “distributed to consumers,” and “released uncontrolled into the environment” are used as the basis for heavier penalties while the rationale for appli- cation of these terms was unclear. Response All the terms used as a basis for assessing heavier penalties show an increase in potential exposure to the chemical sub- stance by either workers, the public, or the environment. ------- Nh 5 TSCA SECTION 5 ENFORCEMENT RESPONSE POLICY OFFICE OF COMPLIANCE MONITORING OFFICE OF PESTICIDES AND TOXIC SUBSTANCES THE U. S. ENVIRONMENTAL PROTECTION AGENCY ------- TABLE OF CONTENTS INTRODUCTION Summary of Rules/Requirements . . . . . 1 !IETERMINING THE LEVEL OF ACTION Admi ni stratlve Clvii Penal ty. . . .. . . . . . . . . . . . . . . . . . . .... 2 Injunctive Action 3 Criminal Sanctions...... . .... ...... .... .... .... 4 ASSESSING A CIVIL ADMINISTRATIVE PENALTY SummaryofthePenaityPo l lcy 5 B ackground.......................................... 5 6 CalculationoftheGravityBasedPenalty............ 6 N ature.................... 1 •• I •..... ....... • 7 Circumstances. ......,.,......,.....•,•.....•..•••,.• 8 E xtent................,............................. 13 G ravlty............................................. 15 Per—Day Assessments 15 One—Day Vlolat lons.................................. 15 Imminent Hazard.................... . . 16 Gravity Based Penalty............................... 16 Adjustlngthe Gravity Based Penalty................. 17 Voluntary Dlsciosure................................ 17 .HlstoryofPrlorVlolat lon..........................19 Culpabillty.......... 19 ExplanatlonofthePena ltyPol lcy ... ......20 N ature...,...,...................................... 20 Circumstances....... ........... . 21 Extent.............................................. 22 GravltyoftheV lolatlon.. ...................2 Adjustment Factors.................................. 27 ------- INTRODUCTION Section 5(a)(1) of the Toxic Substances Control Act (ISCA) requires chemical manufacturers and importers to notify EPA 90 days prior to manufacturing or importing a new chemical substance In the United States. EPA will evaluate the new chemical substance within 90 days based on the information supplied by the submitter. If the Agency finds that the infor- mation supplied is insufficient to permit a reasoned evaluation of the health or environmental effects of the chemical substance and that in the absence of such information the manufacture, distribution, use or disposal of the chemical substance may pose an unreasonable risk of injury to health or the environ- ment, or that the chemical substance may be. produced In sub- stantial amounts which may result in significant human or environmental exposure, the Agency may Issue an order under TSCA §5(e) to prohibit or limit the manufacture, distribution, use or disposal of the chemical substance. TSCA §5(a)(2) allows the Agency to identify uses of a chemical substance which EPA has determined are significant new uses and to require notification of those significant new uses. Certain exemptions from the full reporting and notification requirements are allowed under TSCA §5(h). These exemptions may be found at 40 CFR 720.30k through 720.38 and at 40 CFR Part 723. The major exemptions from notification are research and development, test marketing, small quantities (less than 1,000 kg per year), certain polymers and substances used in instant photographic and peel—apart film articles. Failure to comply with the provisions of TSCA §5 is a violation of TSCA §15 and subject to the remedies found in TSCA §16. Summary of TSCA S5 Requirements Premanufacturing Notification (PMN ) — Under TSCA S5(a)(1) and 40 CFR 720, manufacturers and importers of new chemical substances are required to submit, 90 days prior to manufac- turing or importing, a notice of their intention to conduct such activities as well as any test data in their posession or control in accordance with 40 CFR Part 720.50. ------- —2— Significant New Use Rules (SNUR ) — Under TSCA §5(a)(2) and 40 CFR 721, EPA specifies by rule the use(s) of chemical substances which It considers to be significant new uses. EPA must be notified prior to commencement of any significant new use. Notice of Commencement(NOC ) — Under 40 CF 720.102, EPA re- quires that any person who commences the manufacture or im- portation of a new chemical substance for which that person had previously submitted a PMN, must submit a notice of commencement of manufacture or import on or no later than 30 days after the first day of manufacture or import. TSCA §5(e) Order — Under TSCA §5(e), If EPA determines that the information available in support of a PMN is insufficient to make a reasoned evaluation of the health or environmental effects of a chemical substance, EPA will issue an order imposing controls, restrictions or prohibitions on the manu- facture of the substance in order to address the concerns of EPA. TSCA §5(f) Order — Under TSCA §5(f), If EPR finds that the man- ufacture, Import, processing, distribution, use or disposal of a chemical substance presents or will present an unreasonaDle risk of injury to health or the environment before a rule promulgated under TSCA §6 can protect against such risk, the Administrator may issue an immediately effective proposed rule to impose controls or restrictions to protect against such risk or may Issue an Order to prohibit manufacture, processing, or distribution in commerce. TSCA §5(h) ExemptIons — TSCA §5(h) and 40 CFR 720.30 through 720.38 and 40 CFR 723 exempt certain substances and classes of substances from the full notification and reporting require- ments of TSCA §5. DETERMINING THE LEVEL OF ACTION Enforcement alternatives include civil penalties, injunctive relief, criminal action or some combination of these actions. Notices of noncompliance are not appropriate for TSCA §5 violations. Administrative Civil Penalty An administrative civil penalty will be the appropriate response for most violations of these regulations. ------- —3— Concurrence Civil penalties are to be assessed according to this policy. Regional enforcement personnel must obtain written concurrence from the Office of Compliance Monitoring (0CM) of the Office of Pesticides and Toxic Substances prior to initiating a civil admi ni strative penalty for TSCA §5 violations. Reductions for settlement purposes require the concurrence of 0CM as well and must be in accordance with the TSCA Penalty Policy and this Enforcement Response Policy. Each reduction must be based on the TSCA Penalty Policy or this policy and justified in the Consent Agreement and Final Order with specific dollar amounts attrlbuted to each reduction. Headquarters may relax concurrence requirements on a Region by Region basis after the Regions have gained experience with actions under these rules and this policy. Injunctive Action In most circumstances, a TSCA §16 admt-nlstratlve action will provide a complete and timely remedy for TSCA §5 viola- tions. However, certain cases may present the need for the types of injunctive relief available under TSCA §17 in addi- tion to TSCA §16 administrative actions. Section 17 provides the U.S. District Courts with the juris- diction to: — Restrain persons from taking actions prohibited by TSCA §S 5, 6, and 15. — Compel persons to take actions required by TSCA. — Direct manufacturers, importers, or processors in violation of ISCA to: provide notice of the violation or risk of in— jury to, or repurchase the product from, the consumers of the violative product. — Seize any chemical substance manufactured, imported, pro- cessed, or distributed in commerce tn violation of TSCA. ------- -4— It is Important to note that ISCA §17 does not require an imminent hazard or recalcitrant respondent as a condition to its use. However, the Agency believes that the use of TSCA §17 should be limited to those instances where a civil penalty action will not mitigate a hazardous situation, is not likely to result in timely compliance, or where penalties alone do not provide a complete remedy. Injunctive action is appropriate in the following examples: • illegal production/use which presents a hazard to human health or the environment; o violatIons of TSCA §5(e) or 5(f) orders, Low Volume Ex- emptions, or Test Marketing Exemptions which Involve the failure to use personal protective, equipment or chemical control measures; • contumacy, undue delay, or refusal of a violator to comply with TSCA requirements and regulations; or o repeat offenders for whom the penalty adjustments for past history of violations is unlikely to deter future violations. Criminal Sanctions Criminal sanctions pursuant to TSCA §16(b) are the most serious sanctions available for violations of ISCA §5. Accordingly, criminal sanctions may be sought in situations that, when measured by the nature of the conduct, the compli- ance history of the subject(s) and the gravity of the conse- quences to human health or the environment, reflect the most serious cases of misconduct. ------- —5— ASSESSING A CIVIL ADMINISTRATIVE PENALTY Summary of the Penalty Policy Background The TSCA Civil Penalty Policy, published in the Federal Register on September 10, 1980, establIshes a system for deter- mining penalties in administrative actions brought pursuant to TSCA §16. Under that system, penalties are determined in two stages: (1) determination of a “gravitybased penalty’ (GBP), and (2) adjustments to the gravity based penalty. To determine the gravity based penalty, the following factors affecting a violation’s gravity are considered: • The ‘nature” of the violation. • The ‘circumstances” of the violation. • The “extent’ or potential for harm that could result from a given violation. These factors are incorporated Into a matrix which allows determination of the appropriate gravity based penalty. Once the gravity based penalty has been determined, upward or downward adjustments to the penalty amount are made in con- sideration of these other factors: • culpability, • history of such violations, • ability to pay, • abflity to continue in business, and • such other matters as justice may require. ------- —6— The TSCA Civil Penalty Policy system provides a framework for the development of individual penalty guidances for each rule promulgated under TSCA. This document sets forth Agency policy for the use of the Gravity Based Penalty Matrix to assess penalties for specific violations of TSCA §5 and regula- tions promulgated pursuant to this section. ppl icability This policy is immediately applicable and should be used to calculate penalties for all administrative actions concerning TSCA §5 Instituted after the date of this policy, regardless of the date of violation. Pending cases should be reviewed to determine whether the penalty calculated under this policy is lower than the penalty in the civil complaint. If this policy yields a lower penalty, an amendment to the complaint should be made to substitute the lower penalty. This policy should not be used to raise penalties in existing actions. No case should be settled for an amount higher than the penalty which this policy would yield. Calculation of the Gravity Based Penalty Penalties for TSCA §5 violatIons vary depending on the nature, extent, circumstances and whether penalties are to be calculated as one—day assessments or per—day assessments. In establishing each of these, the Agency considered the following factors in a comparative manner: • Potential for and/or the relative degree of harm to human health or the environment caused by failure to comply. This directly relates to the impact on the Agency’s mandate to evaluate and control the poten- tial for human health r environmental effects of a new chemical substanceA prior to its production or import. o Potential exposure of the public or the environment to an unregulated new chemical substance. o Impact on the validity of the Inventory, which the statute mandates the Administrator to keep current. o Deterrent effect the penalty would have or the like- lihood that the penalty will deter future violations. ------- —7— Nature The nature of the TSCA violation depends on whether the violation relates to chemical control, control—associated data— gathering, or hazard assessment. It Is important to make this determination first. Determining the nature of the violation is necessary prior to using the extent matrix. The following list places the violation types in their respective categories. 1) Chemical Control Violations o Noncompliance with TSCA §5(e) or 5(f) orders, rules, or injunctions and significant new use rules (those aspects dealing with the actual control of the substance, i.e., production, commercial use, disposal, production restr1ctiot s, etc.). o Noncompliance with research and development exemption restrictions (noncompliance with the adequate warning and supervision of a technically qualified Individual requirement). • Noncompliance with test marketing exemption restrictions (those aspects dealing with the actual control of the substance). • Noncompliance with exemption restrictions under 40 CFR 723 (those aspects dealing with the actual control of the substance). 2) Control—Associated Data-Gathering Violations • Noncompliance with the recordkeeplng provisions of TSCA §5 orders, rules, or Injunctions. • Noncompliance with the recordkeeping provisions of exemption restrictions under 40 CFR 723. o Noncompliance with the recordkeeplng provisions of the research and development and test marketing exemption restrictions. 3) Hazard Assessment Violations f,im • All failures to notify EPA when such notification J ,, Is required by law. / / “ ‘), (_ 5 4 / 1 1M 5 • Withholding material information from or submitting false or misleading information in aTSCA §5 notice or exemption request. • Commercial use of a substance produce i without a PNN or valid exemption. ------- —8— o Noncompliance with the reporting provisions of ISCA §5(e) or 5(f) orders, rules, or injunctions. o Any violation not listed previously. Circumstances Once the nature of the violation has been determined, the second step in calculating the penalty is determining the cir- cumstances of the violation. The circumstances determination Is based upon the probability that harm could have taken place — an a priori potential for harm to the environment or the Agency’s decisioninaking or ability to regulate, i.e., potential exposure to an unregulated chemical substance or harm to the integrity of the Inventory. Any after the fact determi nation that harm did or did not take place Is irrele- vant to the initial circumstance level determlnatlon. The gravity based penalty matrix provides for six circumstance levels. Levels one and two represent the Agency’s determina- tion of circumstances where there exists a high probability of harm. Levels five and six represent circumstances of low probability of harm and levels three and four fall between these high and low probabilities. The circumstance level of a violation9s designated in the following manner.. Please note that many of the levels refer to a PMN being subject to a TSCA §5(e) or 5(f) action. Please refer to page 22 for a further explanation of when a substance is subject to a TSCA §5(e) or 5(f) action. Failure to Notify Failure to submit a PMN not subject to a TSCA §5(e) or 5(f) order or exemption when the substance was not distributed to others or further processed for commercial use by the company lsT level 4 vIolation, per—day. Failure, to submit a PMN not subject to a TSCA §5(e) or 5(f) or’der or exemption when the substance was distributed to others or further processed for commercial use by the com- pany Is a level 3 vIolation, per—day. Failure to submit a PMN when the substance is or would have been the subject of a TSCA §5(e) or 5(f) action but was not either distributed to others or further processed for commercial use by the companyTs a level 2 vIolation, per—day. Failure to submit a PMN when the substance Is or would have been the subject of a TSCA §5(e) or 5(f) action and the substance was either distributed to others or fui9 ’Rer processed by the company is a level 1 violation, per—day. ------- —9- Aaien 1ed Failure to submit a P;4N for a chemical substance which would neet all requirements for a polyner exemption under 40 CFR 723.250, except that the company did not file for an exemption, will be assessed as a level violation, per— ay. Failure to submit a PMN for a chemical substance which would meet all requirements for a polymer exemption under 40 CF 723.250, except that the company did not file for an exemption and the substance was further processed for commercial use, distributed to consumers, or released uncontrolled into the environment will e assessed as a level 4 violation, per—day. Failure to submit a Notice of Commencement is a level 3 violation, one—day. Failure to submit a timely Notice of Commencement (early or late submission, up to 30 days prior to manufacture or 30 to 60 days after manufacture) is a level 6 violation, one—day. Failure to submit a timely Notice of Commencement (early or late submission, more than 30 days prior to manufacture or more than 60 days after manufacture) is a level 4 vIolation, one—day. Withholding information or submitting false or misleading information with regard to ilS1’ nificant New Use Notice,’ ” or exemption request is a level 1 violation, per—day. __J Submission of a false Notice of Com’ encement is a level 1 violation, one—day. Noncompliance with TSCA 5(e) or 5(f) Orders, Rules or injunctions ana signiticant New use Rules Violation of on—site restrictions is a level 2 violation, per—day. Violation of off—site restrictions where the substance was either processed by another firm or distributed to consumers or released uncontrolled into the environment is a level 1 Violation, per—day. Failure to submit a Significant New Use Notice when the sub- stance was distributed is a level 2 violation, per—day. Failure to submit a Significant New Use Notice when the sub- stance was distributed to consumers is a level 1 violation, per—day. Violation of production ban or restriction is a level .1 violation, per—day. Failure to generate reports as required is a level 2 violation, per—day. ------- —10— Failure to generate reports as required, where the substance was either processed by another firm or distributed to consumers or released uncontrolled into the environment is a level 1 Tolation, per—day. Late submission of required reports where the substance was not distributed or processed is a level 4 violatIon, per—day. Late submission of required reports where the substance was either processed by another firm or distributed to consumers or released uncontrolled into the environment is a level 3 Vfolation, per-day. Withholding information or submitting false or misleading Information is a level 1 vIolation, per—day. Violation of the recordkeeplng provisions where the firm produces the missing records within 5 days of a written EPA request is a level 4 vIolation, one—day. Violation of the recordkeeping provisions where the firm cannot produce the missing records within 5 days of an EPA request is a level 3 violation, one—day except as specified on page 26 of the policy. Commercial Use of a Substance Produced Without a PMN or Valid Exemption Commercial use violations will be charged in two circumstances: 1. Where a company processes or uses a chemical substance which It did not manufacture and it has reason to know is not on the Inventory. 2. Where a chemical substance was manufactured or imported the- gally on just a few occasions and processed over a long per— - iod of time, the substance would have been subject to a TSCA §5(e) or 5(f) order, and the activity could have caused substantial endangerment to health or the environment. Commercial use violations will be assessed as follows: Violation where the substance was not processed by or dis- tributed to others after recei tbithe user is a level 4 violation, per—day. Violation where the substance was further processed by or distributed to others is a level 3 violation, per—day. Violation where the substance is or would have been the subject of a ISCA §5(e) or 5(f) action but was not processed by or distributed to others is a level 2 violation, per—day. ------- —11— Violation where the substance is or would have been the subject of a TSCA §5(e) or 5(f) action and was either processed by othe rs or released uncontrolled into the environment is a level 1 violatIon, per—day. In cases involving imminent hazard the Agency reserves the right to charge a manufacturer with both failure to submit a PMN and illegal commercial use of the substance. Noncompliance with Test Marketing Exemption Restrictions Overproduction by 10% or less is a level 3 violation, per—day. Overproduction of more than 10% would be charged as a failure to submit a PMN. Violation of exposure related) on—site restrictions is a level 2 vIolation, per—day. Violation of recordkeeplng provisions Is a level 4 violation) one—day except as specified on page 26 of the policy. Violations of the off—site control provisions of a IME where the substance was either distributed to consumers or was released uncontrolled Into the environment is a level 1 violation, per—day. Noncompliance with Research and Development Exemption Restrictions Violations regarding the labeling of the R&D substance where the substance was further processed by another firm is a level 2 violation, per—day. Violations regarding the labeling of the R&D substance where the substance was either distributed to consumers or was / ç\ ,c released uncontrolled into the environment Is a level 1 “ violation, per—day. V Please note that any violation of an R&D exemptionother than failure to adequately label the R&D substance, would cause the charge to be a failure to submit a PMN. Noncompliance with Low Volume Exemption Restrictions Violations regarding the notification of custom rs of the re- strictions on use of the substance is a level 2 violation, per—day. Violations regarding the failure to notify EPA of any changes in site or use of the exempted chemical is a level 2 viola- tion, per—day. ------- —12— Violations of the recordkeeping provisions of the low volume exemption is a level 3 violation, one—day except as specified on page 26 of the policy. Viol-ations of the 1,000 kg. production limit would be viewed as a failure to submit a PMN. Violations regarding the failure to maintain required exposure controls is a level 2.violation, per—day. Noncompliance with the Instant Photographic and Peel—Apart Film Article Exemption Restrictions Failure to limit manufacturing and processing to site(s) listed in the exemption application is a level 5 violation, per—day. Distribution in commerce or use of a peel—apart film article containing a new chemical substance prior to its being cleared through the PMN process would be considered a failure to submit a PMN and subject to the penalties thereunder. Failure to follow the conditions of manufacture for instant photographic or peel—apart film articles where the substance would not have been subject to a TSCA S5(e) or 5(f) order is a level 2 violation, per—day. Failure to follow the conditions of manufacture for instant photographic or peel—apart film articles where the substance would have been subject to a TSCA §5(e) or 5(f) order is a level 1 violation, per—day. Violation of the recordkeeping provisions of this exemption Is a level 3 violation, one—day except as specified on page 26 of the policy. Noncompliance with Polymer Exemption Restrictions Violations regarding the submission of test data with the exemption application is a level 1 violation, per—day. Violations of the recordkeeping provisions of the polymer exemption Is a level 4 violation, one—day. All other violations of the polymer exemption would be charged as a failure to submit a PFIN. Production Production of a chemical substance not subject to a TSCA §5(e) or 5(f) or ter or exemption after submission of a PMN but prior to the expiration of the PMN review period is a level 3 violation, per—day. ------- —13— Production of a chemical substance after submission of a PMN but prior to the expiration of the PMN review period when the substance becomes or would have been the subject of a TSCA §5(e) or 5(f) actIon or the substance was distributed to consumers is a level 2 vio’lition, per—day. Production of a chemical substance prior to the expiration of the PMN review period when the substance becomes or would have been the subject of a TSCA §5(e) or 5(f) actIon and the substance was distributed to consumers is a level 1 vlolatföi, per—day. Other Violations Any other violation not listed above isa level 4 violation, per—day. - Extent The third step in selecting the base penalty for a spe- cific violation from the matrix is to determine the violation’s position on the extent axis. Extent is based on the amount of substance involved In the violation and the nature of the violation. The following table is to be used to determine the extent of a violation. EXTENT MATRIX* Nature Extent Level A B C Major Significant Minor Chemical >2,500 lbs ‘250 lbs to 2,500 lbs >0 to 250 lbs Control >1,134 kg >113.4 kg to 1,134 kg >0 to 113.4 kg Control- >10,000 lbs >1,000 lbs to 10,000 lbs >0 to 1,000 lbs Associated >4,536 kg >453.6 kg to 4,536 kg >0 to 453.6 kg Data— Gathering Hazard >7,500 lbs >750 lbs to 7,500 lbs >0 to 750 lbs Assessment ‘3,402 kg >340.2 kg to 3,402kg O to 340.2 kg * Note exceptions listed on page 14 and 15 under Notes for determining extent. ------- —14— Notes for determining extent 1) Production records will generally serve as the extent basis in the following violation categories: o All fail ures to notify EPA when such noti fication is required by law. Noncompliance with TSCA §5(e) or 5(f) orders, rules, or injunctions. • N9ncompliance with exemptions under 40 CFR Parts 720 and 723. Where there are no production records, the penalty will be assessed at the major extent and may be adjusted If the firm provides data which can be used to determine the extent. If the underlying violative conduct does not relate to production, another more appropriate basis should be employed to determine extent. If, for example, the violator disposes of 5,000 pounds of the substance in violation of the terms of a TSCA §5(e) order, then the amount of the substance disposed, as evidenced in disposal records, .,is the basis of the penalty. 2) The basis of extent in a commercial use violation will be the amount of Illegally produced substance processed or used by the violator on a given day. 3) If the records specified above are unavailable, the penalty is to be assessed from those records that are available if possible or at the major extent level. 4) ViolatIons for withholding information, submitting false or misleading information, or failure to submit reports required by a TSCA §5(e) or 5(f) order, rule or injunc- tion do not lend themselves to extent determinations based on production amounts. For the purposes of de- termining per—day penalties under this ERP, if the the study which is the subject of the violation in- volved human monitoring data, the extent is major. If the study which is the subject of the violation Involved animal laboratory data, the extent is significant. If the study involved physical or chemical properties or environmental fate data, the extent is minor. This is consistent with the TSCA § 8, 12, and 13 Enforcement Response Policy. 5) Violations involving genetically engineered microor- ganisms do not lend themselves to exten.t determinations based on the matrix, due to the extremely small amounts involved. These microorganisms may have the ability to reproduce, creating a larger environmental hazard. ------- —15— Therefore, any violation involving a genetically engineered microorganism will be considered major In extent. Likewise, violations involving any genetic- ally altered or naturally occurring organisms subject to a SNUR or TSCA §5(e) order will be considered major in extent. In the event the Agency Identifies low—risk categories of organisms, violations involving low—risk organisms will be considered significant. 6) All Notice of Commencement violations will be considered major in extent. Gravity Gravity, as used in this ERP, is dependent upon the nature, extent and circumstances of the violation. Per—Day Assessments Where per—day assessments are provided for in the Circum- stances Level section, the base penalty Is calculated for the first occurrence of a violative activity and assessed for each day of subsequent occurrence. For example, a manufacturer or importer Is responsible for notifying EPA prior to j roduct1on or Import- ation of a new chemical substance. Each day of production or Importation of a new chemical substance In violation of the 4’ notIfication requirements of TSCA §5 constitutes a new viola- tion. A day of violation Is counted for each day a chemical substance Is produced regardless of the number of batches pro- duced on a given day. The total amount produced on a given day would be used when determining extent. If production of a chemi- cal substance takes place over a number of days before the manufacturing process is complete, production occurs only when the manufacturing process has been completed. Likewise, a manu- facturer or Importer subject to an order, rule or injunction under TSCA 55 whIch directs him to dispose of the substance or wastes ‘In a particular manner, Is in violation for each day dis— posal occurred contrary to the requirements of the order, rule or injunction. Illegal commercial use violations are assessed under the same principles. Commercial use violations, however, are based on the amount of Illegally produced chemical substance used. ( Per—day penalties assessed on a daily basis (I.e., calendar f days vs. days of actual production) are generally reserved for j violations of the data—gathering provisions of,TSCA §5 where J the Agency needs the data to assess the risks presented by a chemical substance, or situations involving imminent hazard. One—Day Violations Violations of the recordkeeplng provisions bf TSCA §5 are assessed on a one—time basis only except where compliance cannot be determined or noncompliance was intentional. See pages 22 and 26 for a further discussion of these issues. ------- —16— Imminent Hazard Upon review of the facts surrounding a violation, the Agency may make a finding that continued production, sale and distribution of a substance may present an imminent hazard to health and the environment. In the event of such a finding, the Agency may take steps to halt further production, sale and distribution of the product as well as assess the maximum pen- alty of $25,000 per day for each calendar day the exposure from manufacturing and/or commercial use occurred. Thus, if the Agency determined that exposure to a substance found to be an imminent hazard occurred for 90 days, the penalty would be 90 X $25,000 or $2,250,000. Gravity Based Penalty - The Gravity Based Penalty (GBP), a function of the nature, circumstances and extent of each violation, is to be determined by using the following matrix: Whether a penalty is to be assessed as a on e—day assessment r as a continuing violation on a per—day basis Is addressed in the Circumstances section and on page 15. ) GRAVITY BASED PENALTY MATRIX Circumstances Extent . A B C Major Significant Minor Levels 1 High Range $25,000 $17,000 .‘.‘ $ 5 , 00 Q — 2 $20,000 $13,000 $3,000 3 $15,000 $10,000 $1,500 Mid Range 4 $10,000 $ 6,000 $1,000 .5 $ 5,000 $ 3,000 $500 Low Range 6 $ 2,000 $ 1,300 $200 ------- —17— Adjusting the Gravity Based Penalty Follow the adjustment factor application instructions as presented in the general TSCA penalty policy document, “TSCA Civil Penalty System of September 10, 1980 at pages 9—16. Adjustment factors specific to this policy are discussed bel ow. Other Factors As Justice May Require Voluntary Disclosure Penalty amounts for violations of TSCk §5 will be reduced when the violations are voluntarily disclosed by the company. For TSCA §5 violations the penalty reductions for voluntary disclosure are as follows. Voluntary disclosure . . . . . . . . . . . . ......... .25% Immediate disclosure within 30 days of discovery.... 1•I ... .. .25% Takes all steps reasonably - expected ..........................up to 15% Total......up to 65% The reduction for voluntary disclosure and immediate disclosure may be made prior to issuing the Civil Complaint. The Civil Complaint should state the original penalty and the reduced penalty and the reason for the reduction. The Agency wants to encourage voluntary disclosures for TSCA §5 violations. In order to do this, an automatic penalty reduction may be made. To be eligible, a firm must make the disclosure prior to being notified of a pending inspection and the disclosure cannot be one that Is required by TSCA §8(e) or that Is made after EPA has received Information relating to the alleged violation. Voluntary disclosure of a violation will result in a 25% reduction of the penalty. In some cases, companies have delayed 9—12 months in re- porting a violation. An additional 25% penalty reduction may be given to those companies which report the potential violation to EPA within 30 days of having reason to believe that they may be In violation. This reduction is also applicable to firms which have changed ownership. If a company realizes it cannot find a chemical which It is manufacturing on the non—CBI Inventory, and for which it did not submit a PMN, It has reason to believe that it may be in violation. The time limit begins the moment the company has reason to believe that the chemical may not be on the Inventory, not after EPA has confirmed the Inventory status. of the chemical. ------- -18- Environmentally beneficial expenditures above and beyond those specifically required under TSCA are allowable penalty reductions at the Agency’s discretion. Generally, environ- mentally beneficial expenditures may be deducted from the penalty at the Agency’s discretion In accordance with the TSCA Civil Penalty Policy for recall costs and special dis- posal costs, if such action Is requested by EPA or undertaken by the company independently, but not required by TSCA, a regulation, order, or TSCA SS7 or 17 and such action is conducted in a manner satisfactory to EPA. As an alternative to the deduction of costs for environ- mentally beneficial expenditures, a penalty reduction of up to 15% may be made for voluntarily disclosed violations at the Agency’s discretion if the company takes all steps reasonably expected/requested by EPA to mitigate the violation. This Includes timely submission of Information necessary for EPA to assess a violation. Timely submission means within 30 days or a time period agreed upon by EPA and the company. This reduction is not In addition to reductions for environmental expenditures above and beyond that required by the law, but is an alternative. This reduction of up to 15% is only appli- cable to companies which have voluntarily disclosed the violation and may be taken In addition to the Attitude of the Violator adjustment found in the TSCA Civil Penalty Policy. If the steps expected/requested by EPA have not been taken at the time of settlement, this section does not apply. Future activities may be addressed in accordance with the Settlement with Conditions Policy. In some cases, mitigation may not be possible. For example, if the product was distributed In commerce and has already been used, there may be nothing the company can do to rectify the situation. In these cases, no reduction will be given under this heading. In other cases, If no steps are expected because cessation of the violative action Is sufficient, I.e., the chemical clears the PMN process and OTS makes a finding that no corrective actions are necessary, EPA may still give the added 15% reduction for companies that have voluntarily disclosed the violation, provided the penalty exceeds any economic benefit gained by the company. An example of a situation in which EPA may give the addi- tional 15% reductIon Is one in which a company manufactures a chemical not on the Inventory and does not file a PMPI. The company notifies EPA of the possible violation,, immediately ceases all manufacture, processing, and distrib tlon until it files a PMN and the chemical clears the review period without being a candidate for a TSCA 55(e) or 5(f) actIon. ------- —19— Economic Benefit In no cases shall reductions be given if the reduced penalty does not exceed the economic benefit gained from non- compliance. EPA should require the company to present infor- mation concerni’ g economic benefits gained from the violative action prior to the reduction of the penalty except for the 25%/50% off for voluntary disclosure. In all cases, EPA wishes to encourage voluntary disclosure. Attitude The existing adjustment provision for the Attitude of the Violator In the TSCA Civil Penalty Policy (Septemeber 10, 1980) may also be applied to adjust the penalty by up to 15%. Please note that this adjustment may decrease or increase the penalty by 15%. This adjustment applies equally to companies that voluntarily disclosed violations and those that did not. A company would generally qualify for a downward adjustment if it Immediately halts the violative activity, takes steps to rectify the situation and there is no finding of culpa- bility. However, such a reduction is at the discretion of EPA. - History of Prior Violation The Agency will disregard the firm’s prior history of violations in calculating the penalty for a self—disclosed violation. However, for violations discovered by the Agency, the Agency will address history of prior violations as indi- cated in the TSCA Civil Penalty Policy, even if the prior history results from a violation which was voluntarily disclosed. Culpability - The culpability of a violator may be taken into account when a violator does not have control over the violation charged. An example would be a company importing a chemical substance from a foreign manufacturer where the foreign manu- facturer falsely certifies that the substance is on the TSCA Inventory and the company importing the substance only knows the trade name of the substance. The importing company must be able to provide a copy of the written false. certification and show that they were unable to ascertain the Identity of the substance by any other means. The Agency can reduce the penalty by up to 25% In such situations. In the event of further violations of this type, history of prior violation would not be considered when determining the penalty. ------- -20- Explanation of the Penalty Policy Nature The nature of a TSCA §5 violation depends on whether the violation deals with chemical control, control—associated data—gathering, or hazard assessment. 1. Chemical control regulations are aimed at minimizing the risk presented by a chemical substance by placing constraints on how the substance is handled. Section 5(a)(2) authorizes the Administrator to mak a determination that use of a hemlca1 Is a signifi- cant new use and require the manufacturer or importer to notify EPA prior to Initiating such a use. Sections 5(e) and 5(f) authorize a wide variety of WiiiiTcal control requirements from bel Jig _ restrjç• ¶Töii to manufacturing bans. Section 5(h)(1) author— Izes the Administrator to Impose restrictions upon the manufacture or processing of a test marketed substance. Violations of those restrictions that place constraints on how a substan_ce is handled fall into this category. Section 5(h)(3) obligates a firm producing a substance under a research and de- velopment exemption to give adequate warning to employees if that substance Is dangerous. This is also a constraint on a substance’s handling and is included in this category. 2. Control—associated data—gathering requirements are the recordkeeping and/or reporting requirements associated with a chemical control regulation. These requirements enable the Agency to evaluate the effectiveness of the regulation and to monitor compliance. Some requirements in TSCA §5(e) and 5(f) orders, rules, or injunctions would fall into this category (i.e., a section 5(e) order that requires the manufacturer to keep records of all purchases of the regulated substance). Some test marketing exemption restrictions would also fall into this category as section 5(h)(1)(B) authorizes the Administrator to Impose, among other things, recordkeeping and/or reporting requirements. 3. Hazard assessment requirements are used to develop and gather information necessary to we igh the risks and benefits presented by particular chemical sub- stances and to impose chemical control requirements when appropriate. This category includes violations for failure to notify, withholding information from EPA or submission of false or misleading information. ------- —21— Circumstances Circumstances are used in the penalty policy to determine the probability of potential harm. In other words, a variety of facts surrounding the violation as it occurred are examined to determine whether the circumstances of the violation are such that there is a high, medium, or low potential for harm. To calculate the penalty first use the nature determination list to select the appropriate nature category and then select the appropriate circumstance. Application of the Circumstances Factor to Section 5 1) Chemical control . Chemical control violations in- clude noncompliance with TSCA §5(s) or 5(f) actions, failure to submit a significant new use notice, noncompliance with a research and development exemp- tion restriction on adequate warning, noncompliance with test marketing exemption restrictions on the actual control of the substance, improper commercial use of a substance produced in violation of a TSCA §5(e) or 5(f) order, or noncompliance with any ex- emption restriction on the use of_a substance found under 40 CFR Part 723. For these violations, the initial circumstance level is based on the severity of the violation. Circumstance evaluations are adjusted by the degree of potential environmental exposure and potential risk posed by the chemical. 2) Control—assocl ated data—gatheri ng . Control—associ— ited data—gathering violations include noncompliance with the recordkeeplng provisions of TSCA §5(e) or 5(f) actIons and exemption restrictions under 40 CFR Parts 720 and 723. For these violations the circum- stances are dependent on the extent to which the Agency’s ability to monitor and/or evaluate the risks posed by the substance or the company’s com- pliance with the substantive legal requirements Is impaired. 3) Hazard assessment . Hazard assessment violations Include failure to submit a premanufacturing noti- fication and associated commercial use, failure to submit a notice of commencement, withholding infor- mation, submitting false or misleading information, and noncompliance with the reporting provisions of TSCA §5(e) or 5(f) actions. ------- —22— When determining whether a PMN is subject to a TSCA §5(e) or 5(f) action, there are Instances where rather than Imposing controls under a TSCA §5(e) order with testing triggered at a particular production volume or time, EPA requires testing upfront before manufacture may commence. If the company refused to either do the testing or withdraw the PMN , EPA would then unilaterally issue an “adversarial” ISCA §5(e) order prohibiting any manufacture. This type of case would be treated as a TSCA §5(e) or 5(f) action and subject to higher penalties. When determining the circumstance level for recordkeeping violations when EPA has requested the missing records, EPA must be able to determine compliance from the records which are provided or the charge would be considered failure to produce the missing records. Where records are necessary to determine compliance with a requirement of a TSCA §5 action, rule, or injunction and the records cannot be produced, EPA reserves the right to charge per day penalties. PMN violations involving chemical substances which meet all requirements for a polymer exemption under 40 CFR 723.250, except the company did not file for an exemption, will be assessed at a level 5 circumstance. EPA has determined that chemicals which qualify for these exemptions are of less concern as a hazard. Extent Extent is used to take into consideration the degree, range, or scope of the violation. The Extent Matrix (pg. 13) provides for three levels of extent: Major, Significant, and Minor. The three levels are generally based upon the amount of substance involved in the violative conduct. Production records will generally serve as the penalty ba-sis In the following violation categories: o All failures to notify when such notification is required by law. o Noncompliance with TSCA §5(e) or 5(f) orders, rules, or Injunctions and significant new use rules (except reporting violations). 1 ° Noncompliance with test marketing or research and development exemption restrictions. o Noncompliance with exemption restrictions under 40 CFR Parts 720 and 723. ------- —23— If a chemical substance is manufactured for commercial purp.oses as part of a chemical mixture, the amount of the chemical substance from which the mixture is made is used to calculate the penalty. If a chemical mixture made from a chemical substance Is Incorporated into an article, the penalty is calculated from the amount of the chemical sub- stance used to manufacture the chemical mixture. If the amount of chemical substance used to manufacture the chemical mixture is unknown, the amount of chemical mixture will be used to determine extent. If a portion of a batch containing an illegally manufactured chemical substance is sold/distri- buted for commercial purposes, the entire batch Is considered to be manufactured for commercial purpo es and the amount of the chemical substance used to manufacture the entire batch is used to calculate the penalty. Likewise, if one batch of an illegally manufactured chemical substance is sold/distributed for commercial purposes, all other batches of the chemical substance are considered to be manufactured for commercial purposes. If a firm disposes of a substance in violation of a test marketing restriction or a section 5(e) Injunction, then the amount ii legally disposed is the basis of the penalty. TToiations involving genetically altered, naturally oc- curring or genetically engineered microorganisms will all be placed in the major extent category due to the Agency’s general level of concern over the potential for harm from unregulated environmental release. In the event the Agency Identifies low risk categories of organisms, violations in- volving low risk organisms will be placed In the significant extent level. It should be noted that if those records specified above are unavailable, the penalty should be assessed on those records that are available or where there are no records, asiume the violation is major In extent. Determining extent for violations involving withholding I n formation, s.ubjijt.t_th gfaiieor ml s] _ e&ding.Jn.fp rmat ion, or failure to generate reports as required by a TSCAt5(e) or 5(f) action requires different criteria. Th s..e_v.to.1aLt_i.o.ns._a-r-e a .!Jsed _ for _ e.ach..A yt e violation occurred beginning fr ip the day the information was submitted or should h&v..e.....be..e1L . submitted. While the amount ri substance produced has i ron the potential exposure of the public or environ- ment to that substance, the harm is caused by the failure to submit the data or submit true and complete data. Consistent with the ISCA §S8 , 12 and 13 Enforcement Response Policy, extent is determined by the type of data involved in the violation. If the subject study involves laboratory animal data, the extent is determined to be significant. If the subject study involves physical/chemical properties or environmental fate data, the extent level is minor. ------- —24— The tree levels of extent (major, significant and minor) are based on the potential for harm to health or the environ- ment. As stated previously, chemical control violations are considered the most serious due to the fact that risks have largely been identified and steps have been taken to mitigate those risks. Thus, the amount of production/disposal necessary to place a violation into the major and significant categories is substantially less than the amounts which place a violation into those same categories for hazard assessment violations or control—associated data—gathering violations. Hazard assessment violations Impair the Agency’s ability to determine the risks presented by a particular new chemical substance and impose control requirements. Because the Agency has no way of knowing whether the substance presents a risk to health or the envi- ronment, hazard assessment violations re placed between chem- ical control violations and control—associated data—gathering violations in terms of the amount of substance necessary to place a violation in the various extent levels. Control—asso- ciated data—gathering violations impair the Agency’s mission to mitgate threats to health and and the environment the least. These violations involve the recordkeeping provisions of a TSCA §5 action. Nonetheless, they are Important for the Agency to assure compliance. Application of the Extent Factor to Section 5 1) Chemical control violations . The Agency will have either knowledge or concerns that the substance may be harmful. Thus the potential for harm is greatest in this category. An amount of a substance that is considered minor or significant in the two other categories may be considered major here. A minor designation covers amounts from 0 to 250 lbs. (0 to 113.4 kg.); a significant designation covers amounts greater than 250 lbs. to 2,500 lbs. (113.4 kg. to 1,134 kg.); the major designation is assigned to amounts greater than 2,500 lbs. (1,134 kg.). 2) Control—associated data—gathering . Since production, distribution, etc. is always allowed, the penalties escalate more slowly than for the chemical control category violations: minor is 0 to 1,00G lbs. (0 to 453.6 kg.); significant is greater than 1,000 lbs. to 10,000 lbs. (453.6 kg. to 4.536 kg.); major is greater than 10,000 lbs. (4,536 kg.). 3) Hazard assessment . in this category, the Agency can neither assume that the substance is harmless nor harmful. The violations, however, are more serious than those in the control-associated data-gathering category: minor is 0 to 750 lbs. (0 to 340.2 kg.); significant is greater than 750 lbs. to 7,500 lbs. (340.2 kg. to 3,402 kg.); and major is greater than 7,500 lbs. (3,402 kg.). ------- —25— Gravity of the Violation Gravity refers to the overall seriousness of the violation. As used in this penalty system, gravity Is a dependent variable (I.e., the evaluation of nature, extent, and circumstances will yield a dollar figure in the matrix that Is the gravity based penalty). Imminent Hazard Imminent hazard violations require the Agency to make a finding that a particular violative substance presents an im- minent hazard to health or the environment. Penalties for violations involving imminent hazards are assessed for each day the violation continues at the maximum penalty allowable when a company manufactures and uses the hazardous chemical. In these cases separate charges, one for manufacturing and one for commercial use may be assessed. Per—Day Penalties or One—Day Assessments TSCA 516(a)(1) provides not only that civil penalties may be assessed up to $25,000 but that each day a violation con- tinues Is a separate violation for which peiialtles may be assessed. For the purposes of this ERP, per—day penalties will be assessed for each day a violation of TSCA 55 occurs. If, for example, a firm Is charged with the illegal manufacture of a chemical substance, each separate day of manufacture constitutes a violation regardless of the number of batches produced during that day. The total amount produced In a day would be used as the basis for the extent of the violation if a company has more than one facility illegally producing a substance on a given day. Likewise, If a firm illegally disposed of a substance, the penalty is based on the number of days the disposal occurred regardless of the number of shipments for disposal on a given day. The total amount of a substance produced or disposed of on a given day Is used when determining extent. Where the ma-nufacture or processing of a substance takes several days to complete, the penalty Is based only on the day the manufac- turing or processing was completed. For example, If It takes 3 days to manufacture a substance In violation of TSCA §5, the penalty would be assessed for the day the manufacture of the substance was completed (day 3). ------- —26— Violations which warrant daily penalties are those which impair the Agency’s ability to assess the risks to public health or the environment. These penalties are assessed from the date of occurrence to the date of discovery. Per—day penalties will be assessed for the following viola- tions: 0 Withholding information or submitting false or mislead- ing information • Failure to generate reports as required by a TSCA §5(e) or 5(f) action 0 Noncompliance with TSCA §5(e) and .5(f) orders, rules, and Injunctions (chemical control aspects) • Noncompliance with research and development exemption restrictions (violation of adequate warning and ex- pert supervision requirements) O Commercial use of an illegally produced substance 0 Noncompliance with exemption restr9ctions under 40 CFR Parts 720 and 723 (chemIcal control aspects) 0 Failure to notify Penalties for recordkeeping violations will be assessed on a one—time basis. Violations of these types do not gener- ally pose as great a risk to public health or the environment. The violations arise from a single violative act. One—day penalties will be assessed for the following violations: • Noncompliance with section 5(e) and 5(f) orders, rules, and injunctions recordkeeping provisions only. The Agency reserves the right to assess per day pen- alties for recordkeeping violations when compliance with a requirement of a TSCA §5 action, rule or injunction cannot be verified. • NoncomplIance with exemption restrictions under 40 CFR Parts 720 and 723 involving recordkeeping provisions. 0 Notice of Commencement violations. The Agency re- serves the right to charge a per day violation in those cases where the notice was intentionally withheld by the company. ------- —27— Multiple Violations/Chemicals Multiple violations of a TSCA §5 action, rule, or injunc- tion will be assessed separately for each distinct violation. Where more than one chemical substance is In violation, penal- ties will be assessed for each violative chemical. Adjustment Factors Voluntary Disclosure This is an activity which the Office of Compliance Moni- toring (0CM) wants to encourage. If EPA receives a voluntary disclosure, the Agency can proceed with action to rectify a situation even if the manufacturer is reluctant. Actions by EPA to convince a violator to do the “right thing” may include penalties issued on a per—day basis, TSCA §S7 or 17 actions, or other additional rule—making. Although 0CM considered including the condition that the manufacturer acted in good faith prior to the violation and that he ceased the violative act as soon as he had reason to know of the violation, 0CM decided not to include this as a condition for the 25% reduction for the following reasons: 1) If the violation continues, EPA may assess penalties against the manufacturer for each day of violation. 2) In cal cul ating the penal ties for vio- lations after the violator knew of the violation, a culpability factor for those days may be added. 3) If the violator intended to violate ISCA prior to disclosing the violation, the penalties for the entire period of violation may be increased based on a culpability finding. 4) If the violator does not act to rectify the situation, his penalties may be increased based on attitude if no finding of culpability is made. 5) Irrespective of the circumstances of the violation, the Agency wants the manufacturer to report it. Immediate Voluntary Disclosure 0CM wants to further encourage prompt reporting. There- fore, an added Incentive is provided so that the Agency is notified soon after the manufacturer has reason to know of a potential violation. History of Noncompliance As a further incentive for the voluntary disclosure of violations, the Agency has decided to forego the imposition of penalty increases for a history of noncompliance in assessing penalties for voluntarily disclosed violations. However, a voluntarily disclosed violation does constitute a violation and is to be used to increase penalties for future violations which the Agency discovers. ------- Definitions Consumer — Any person who uses a chemical substance for any purpose. Off—site Restrictions — Off—site restrictions are those re- strictions placed on a substance after it leaves the original site of manufacture or processing. On—site Restrictions — On—site restrictions are those restric- tions Imposed upon a Company by EPA through a TSCA §5 actIon, rule, or Injunction at the site of manufacture or processing. Recordkeeping — Recordkeeping is that information the Agency requires the Company to retain at its premfses and provide to EPA upon request. Reports — Reports are those data the Agency is requiring the Company to submit to EPA under TSCA §5. ------- APPENDIX 1 EXAMPLES Failure to Notlf Example 1 A company has produced a chemical substance, which is not on the Inventory, for 5 years, with production occurring on 50 days each year, and 1,000 pounds of the substance produced on each day of production. The chemical substance Is consumed in another chemical reaction. The company stops production Immediately upon discovery of the violation, voluntarily discloses the violation within 30 days, submits a PMN within 30 days and takes all the steps EPA requests of them. The PMN goes through review without any health or environmental concerns being raised. The company Is charged with a failure to submit a PMN, level 4, signifIcant, per—day. $6,000 X 5 X 50 = $1,500,000 80% reduction in penalty warranted — $1,20fJ,000 Final Penalty — $300,000 Example 2 A company has produced a chemical substance, which Is not on the Inventory, for 4 years with production occurring 50 days per year, and 8,000 pounds of the substance produced on each day of production. The chemical substance is further processed by the company on 100 days per year, 4,000 pounds processed on each day and sold in an end—use product. The company discovers the violation, Immediately stops production, volun- tarily discloses the violation within 30 days, submits a PMN within 30 days and takes all steps EPA asks of them. The PMN review Identifies a substantial environmental concern and the company subsequently enters Into a TSCA §5(e) consent order to address this concern. The company Is charged with a failure to submit a PMP4, level 1, major, per—day. 4 X 50 X $25,000 = $5,000,000 80% reduction in penalty warranted — $4,000,000, Final Penalty — $1,000,000 ------- Exam p1 e 3 . S” “ 1 L1_4i4411”V #4.’ pany has produced a chemical substance, which is not on nventory, for 8 years, with production taking place 25 j3 a year, and 3,000 pounds of the substance produced on each day of production. The chemical substance is incorpor- ated into a product which is sold to its customers for use in a consumer p duct. The company discovers the violation and reports it . EPA 75 days later, after it has developed a legal substitute for the illegal chemical substance and has been notified of a pending inspection. A PuN is not filed as the company has no intention of making the illegally pro- duced substance again. The company produces production records for the substance only after missing two deadlines for submitting the records. The company is charged with a failure to submit a PMN, level 3, significant, per—day. $10,000 X 8 X 25 = $2,000,000 15% penalty adjustment upward for attitude — $300000 Final Penalty — $2,300,000 Example 4 A company failed to submit a Notice of Commencement to EPA. The first day of production yielded 3,000 pounds of the bstance. EPA discovered the violation. The company is arged with a failure to submit a Notice of Commencement, vel 3, —igifi -tnt , one—day. The company r ’be charged s1f’,ooo. Example 5 A company produced a chemical substance regulated by a SNUR, for a significant new use as defined by the SNUR, without submitting ‘a Significant New Use Notice to EPA. The sub- stance was incorporated into a consumer use product. The company produced the chemical 9 times, with 3,000 pounds produced on each occasion. EPA discovered the violation. The company is charged with a failure to submit a Significant New Use Notice, level 1, major, per-day. 9 x $25,000 = $225,000 ------- —2— Example 3 A company has produced a chemical substance, which is not on the Inventory, for 8 years, with production taking place 25 days a year, and 3,000 pounds of the substance produced on each day of production. The chemical substance is incorpor- ated into a product which is sold to its customers for use in a consumer product. The company discovers the violation and reports it to EPA 75 days later, after ft has developed a legal substitute for the illegal chemical substance and has been notified of a pending inspection. A PMN is not filed as the company has no intention of making the illegally pro- duced substance again. The company produces production records for the substance only after missing two deadlines for submitting the records. The company is charged with a failure to submit a PMN, level 3, significant, per—day. $10,000 X 8 X 25 = $2,000,000 15% penalty adjustment upward for attitude — $300,000 Final Penalty — $2,300,000 Example 4 A company failed to submit a Notice of Commencement to EPA. The first day of production yielded 3,000 pounds of the substance. EPA discovered the violation. The company is charged with a failure to submit a Notice of Commencement, level 3, significant, one—day. The company would be charged $10,000. Example 5 A company produced a chemical substance regulated by a SNUR, for a significant new use as defined by the SNUR, without submitting a Significant New Use Notice to EPA. The sub- stance was Incorporated into a consumer use product. The company produced the chemical 9 times, with 3,000 pounds produced on each occasion. EPA discovered the violation. The company is charged with a failure to submit a Significant New Use Notice, level 1, major, per—day. 9 x $25,000 = $225,000 ------- —3— Example 6 An inspector discovers a study that should have been submitted In conjunction with a PMN application. The study Involved ani- mal testing data. The chemical substance was produced for 1 year before the violation was detected. The company is charged with witholding information, level 1, significant, per—day. $17,000 X 365 = $6,205,000 Example 7 A company produces a chemical substance’under a TSCA §5(e) order. The order requires the company to train workers and requires the employees to wear respirators while engaged in the manufacture of the substance. The Inspector discovers that the company has not conducted training as required and that the workers do not wear respirators, or have them available, while engaged in the manufacture of the substance. Production has taken place on 30 days with 5,000 pounds of the substance pro- duced each day. The company is charged with two counts, fail- ure to provide training and failure to require their employees to wear respirators, level 2, major, per—diy. $20,000 X 2 X 30 $1,200,000 Example 8 A company produces a chemical substance under a TSCA §5(e) order. The order requires the company to incinerate all wastes derived from the production of the chemical substance. An inspector discovers that the company has. not incinerated the wastes as required, but has been releasing the wastes to water after primary treatment. Disposal took place on 50 days w1 th 2,000 pounds disposed of each day. The company is charged with failure to follow the restrictions of the TSCA §5(e) order regarding disposal, level 1, significant, per— day. $20,000 X 50 = $1,000,000 ------- -4— Example 9 A company produces a chemical substance under a TSCA §5(e) order. The order requires the company to either stop pro- duction or submit a study to EPA after producing 400,000 pounds of the substance. The company submits the study to the Agency and the study is approved. A subsequent Inspection re- veals that the company had produced 450,000 pounds of the sub- stance prior to submItting the study, producing 5.000 pounds of the substance on 10 different days. The company is charged with violation of a production ban, major, level 1, per—day. $25,000 X 10 = $250,000 Example 10 A company has manufactured and processed a chemical substance, which is not on the Inventory, for 8 years with manufacturing occurring 100 days each year, 5 000 pounds manufactured each day and processing occurring 200 days each year. with 2,500 pounds processed each day. The processed chemical substance is Incorporated Into an end use product. An inspector dis- covers the violation. A review of the chemical by EPA iden- tifies a substantial environmental concern which would have placed the the substance as TSCA §5(e) order candidate. The company is charged with a failure to submit a PMM, level 1, significant, per—day. $20,000 X 8 X 100 = $16,000,000 Example 11 A company applied for and recieved a low volume exemption for a chemical substance. An inspector discovers that the company pr.oduced 1500 kg of the substance in 3 different years with production occurring on 3 days each year, 500 kg produced each day. The chemical substance would have had a TSCA §5(e) order Issued If It had not been granted a low volume exemption. The chemical substance was distributed to customers. The com- pany would be charged with a failure to file a PMN, level 1, significant, per—day. $20,000 X 3 X 3 = $180,000 ------- —5.- Example 12 A company produced a chemical substance which is not on the Inventory, for 5 years, with production occurring on 50 days, 5,000 pounds produced each day. The chemical substance was further processed for. 100 days each year with 2,500 pounds of the substance processed each day. The finished product con- taining the chemical substance was distributed to consumers. The chemical substance was a polymer that otherwise would have qualified for a polymer exemption. The company is charged with failure to file a PMN, level 5, significant, per—day. $3,000 X 5 X 50 = $750,000 Example 13 Company A solicited several manufacturers to produce a chemical substance for them. They were advised by one company that the substance did not appear on the Inventory and that a PMN would have to be filed prior to manufacturing. Another company agreed to produce the chemical for Company A. Company A commercially used the chemical substance for 5 years, 1 0 days per year, processing 3,000 pounds of the substance on each occasion. EPA discovered the violation at the manufacturing company and charged the manufacturing company with a failure to file a PMN. The PMN was filed and no problems were found with the chemical substance auring the PMN review. A subsequent Inspection of Company A discovered the letter from the manufacturer who had advised Company A of the status of the chemical. Company A was charged with commercial use of an illegally manufactured sub- stance, level 3, major, per—day. 5 X 100 X $15,000 = $7,500,000 ------- 1 Failure to Notify Failure to submit a PMN order or exemption when to consumers or further company. PER—DAY/ NATURE ONE—DAY Per—day Per— day Per— day Per—day Per—day Per—day One—day VIOLATION not subject to a TSCA §5(e) or 5(f) the substance was not distributed processed for commercial use by the Filure to submit a PMN not subject to a TSCA §5(e) or 5(f) order or exemption when the substance was distributed to consumers or further processed for commercial use by the com- pany. Failure to submit a PMN when the substance is or would have been the subject of a TSCA §5(e) or 5(f) action but was not either distributed to consumevs or further processed for commercial use by the company. — Failure to submit a PMN when the been the subject of a TSCA §5(e) substance was either distributed processed by the company. substance Is or would have or 5(f) action and the to consumers or further LEVEL 4 3 2 1 5 4 3 HA HA HA HA HA HA HA Failure to submit a PMN for a chemical substance which would meet all requirements for a polymer exemption under 40 CFR 723.250. except that the company did not file for an exemption. Failure to submit a PMN for a chemical substance which would meet all requirements for a polymer exemption under 40 CFR 723.250, except that the company did not file for an exemption and the substance was further processed for commercial use, distri- buted to consumers, or released uncontrolled into the envi- ronment. Failure to submit a Notice of Commencement. HA — Hakard Assessment CC — Chemical Control CADG - Control-Associated Data—Gathering ------- V It.) LA Ti 0;i lure to submit 3 timely Notice of Commencement (early or late submission, up to 30 days prior to manufacture or 30 to 60 days after manufacture). Failure to submit a timely Notice of Commencement (early or late subr ’iission, more than 30 days prior to manufacture or more than 61J days after manufacture). WittihoiJing information or submitting false or misleading information with regard to a PMN, Significant New Use Notice, or exc:nption request. Submission of a false Ilotice of commencement. Noncompliance with TSCA §5(e) or 5(f) Orders, Rules or Injunctions and Significant New Use Ru’es Violation of on—site restrictions. Violation of off-site restrictions where the substance was either processed by another firm or distributed to consumers or released uncontrolled into the environment. Failure to submit a Significant New Use Notice when the sub- stance was not distributed. Failure to submit 3 Significant New Use Notice when the sub- stance was distributed to consumers. “iolation of production ban or restriction. Failure to generate reports as required. LEVEL 6 4 1 1 2 1 2 1 1 2 PE R—DAYI ONE—JAY One-day One-day Per—day (The—day Per—day Per—day Per-day Per-day Per—day Per-deS’ 2 5 Amended 1IATIJRE HA IA HA HA Cc Cc CC CC cc hA ------- 3 VIOLATION LEVEL PER—DAY/ NATURE ONE-DAY Failure to generite reports as required, where th€ ubstance was either processed by another firm or distributed to 1 Per—day HA consumers or released uncontrolled into the environment. Late submission of required reports where the substance was not distributed or processed. 4 Per-day HA Late submission of required reports where the substance was either processed by another firm or distributed to consumers 3 Per—day HA 21. released uncontrolled into the environment. Withholding information or submitting false or misleading 1 Per—day - HA information. Violation of the recordkeeping provisions where the firm produces the missing records within 5 days of an EPA request. 4 One—day CADG Violation of the recordkeeping provisions where the firm cannot produce the missing records within 5 days of an EPA 3 One—day CADG request except as specified on page 26 of the policy. Commercial Use of an Illegally Produced Substance Commercial use violations will be charged In three circumstances: 1. When a company processes or uses a chemical substance which it did not manufacture and it has reason to know Is not on the Inventory. 2. When a chemical substance was manufactured or imported ille- gally on just a few occasions and processed over a long per— lod of time, the substance would have been subject to a TSCA §5(e) or 5(f) order, and the activity could have caused substantial endangerment to health or the environment. ------- 4 VIOLATION LEVEL PER—DAY/ NATURE ONE-DAY Comn rcial use violations will be assessed as follows: Violation where the substance was not processed by or dis- 4 Per-day CC tributed to others after receipt by the user. Violation where the substance was further processed by or 3 Per—day CC distributed to others. Violation where the substance Is or would have been the subject of a TSCA §5(e) or 5(f) actIon but was not processed by or 2 Per—day CC distributed to others. - Violation where the substance Is or would have been the subject of a TSCA §5(e) or 5(f) action an was either processed by 1 Per—day CC others or released uncontrolled into the environment. Noncompliance with Test Marketing Exemption Restrictions Overproduction by 10% or less. 3 Per—day CC Overproduction of more than 10% would be charged as a failure to submit a PMN. Violation of exposure related, on—site restrictions. 2 Per—day CC Violation of recordkeeplng provisions except as specified on 4 One—day CADG page 26 of the policy. Violations of the off—site control provisions of a TME where the substance was either distributed to consumers or was 1 Per—day CC released uncontrolled Into the environment. — Noncompliance with Research and Development Exemption Restrictions Violations regarding the labeling of the R&D substance where the substance was further processed by another firm. 2 Per—day CC ------- VIOLATION LEVEL PER—DAY/ NATURE ONE-DAY Violations regarding the labeling of the R&D substance where the substance was either distributed to consumers or was 1 Per—day CC released uncontrolled Into the environment. Please note that any violation of an R&D exemption other than failure to adequately label the R&D substance, would cause the charge to be a failure to submit a PMN. Noncompliance with Low Volume Exemption Restrictions Violations regarding the notification of customers of the re- strictions on use of the substance. 2 Per—day CC Violations regarding the failure to notify EPA of any changes i n si te or use of the exempted. chemical. 2 Per—day CC Violations of the recordkeeplng provisions of the low volume 3 One—day CADG exemption except as specified on page 26 of the policy. Violations of the 1,000 kg. production limit would be viewed as a failure to submit a PMN. Violations regarding the failure to maintain required exposure 2 Per—day CC controls. Noncompliance with the Instant Photographic and Peel-Apart Film Article Exemption Restrictions Failure to limit manufacturing and processing to site(s) listed in the exemption application. 5 Per—day CC Distribution in commerce or use of a peel—apart film article containing a new chemical substance prior to its being cleared through the PMN process would be considered a failure to - submit a PMN and subject to the penalties thereunder. ------- 6 VIOLATION LEVEL PER—DAY/ NATURE ONE-DAY Failure to follow the conditions of manufacture or instant photographic or peel—apart film articles where the substance 2 Per—day CC would not have been subject to a TSCA §5(e) or 5(f) order. Failure to follow the conditions of manufacture for Instant photographic or peel—apart film articles where the substance 1 Per—day CC would have been subject to a TSCA §5(e) or 5(f) order. Violation of the recordkeeping provisions of this exemptIon 3 One—day CADG except as specified on page 26 of the policy. Noncompliance with Polymer Exemption Restrictions Violations regarding the submission of test data with the 1 Per—day HA exemption application. Violations of the recordkeeping provisions of the polymer exemption except as specified on page 26 of the policy. 4 One—day CADG All other violations of the polymer exemption would be charged as a failure to submit a PMN. Production Production of a chemical substance after submission of a PMN but prior to the expiration of the PMN review period. 3 Per—day HA ------- 7 VIOLATION Production of a chemical substance after submission of a PMN but prior to the expiration of the PMN review period when the substance becomes or would have been the subject of a TSCA §5(e) or 5(f) action or the substance was distributed to consumers. Production of a chemical substance prior to the expiration of the PMN review period when the substance becomes or would have been the subject of a TSCA §5(e) or 5(f) action and the substance was distributed to consumers. Other Violations Any other violation not listed above. EXTENT MATRIX LEVEL 2 1 4 PER—DAY/ ONE—DAY Per—day Per-day Per—day Nature A Extent Level C B Major Significant Minor Chemical >2,500 lbs >250 lbs to 2,500 lbs >0 to 250 lbs Control >1,134 kg >113.4 kg to 1.134 kg >0 to 113.4 kg Control- >10,000 lbs ‘1,000 lbs to 10,000 lbs >0 to 1,000 lbs Associated >4,536 kg >453.6 kg to 4,536 kg >0 to 453.6 kg Data- Gathering Hazard >7,500 lbs >750 lbs to 7,500 lbs >0 to 750 lbs Assessment >3,402 kg >340.2 kg to 3,402 kg >0 to 340.2 kg NATURE HA HA HA ------- 8 GRAVITY BASED PENALTY MATRIX Ci rcumstances Extent A B C Major Significant Minor Levels 1 $25,000 $17,000 $5,000 High Range 2 $20,000. $13,000 $3,000 3 $15,000 $10,000 $1,500 Mid Range 4 $10,000 $ 6,000 $1,000 5 $ 5,000 $ 3,000 $500 Low Range 6 $ 2,000 $ 1,300 $200 ------- Sri, ) UNITED STAT S ENVIRONMENTAL PROTECTION AGENCY - wTIg-- WASHINGTON. D.C. 20460 JUN 81989 OFFICC OP PESTICIDES AND TO IIC SUBSTANCES MEMORANDUM SUBJECT: Amendment to the TSCA §5 Enforcement Response Policy FROM: John J. Neylan III, Director \V3 Policy and Grants Division Office of Compliance Monitoring TO: Addressees This memorandum amends the ISCA §5 Enforcement Response Policy by revising the penalty for falsification of a Notice of Commencement (MOC). This change would apply to those in- stances where a company has submitted a Notice of Commencement in anticipation of production or importation, the event does not occur, and the company never does produce or import the substance.. This change has been made in response to numerous comments that the policy issued on August 5, 1988, created a large in- equity in penalty when a company submits a Notice of Commence- ment but does not produce a substance, as compared to a company that produces a substance without submitting a Notice of Com- mencement. In the first situation, the current ERP requires that the violation be charged as a false NOC and would subject the violator to per day penalties from the day the false NOC was submi tted to the day of discovery of the violation with the potential of very large penalties. The provision to allow for per day penalties for each calendar day a falsification occurs, was created for those Si tuations where the falsi ficatlon pre- vents the Agency from making a reasoned evaluation of the chem- ical substance. This is not the case for a false NOC. The chemical has been reviewed and mistakenly placed on the Inven- tory. A reasoned evaluation of the chemical substance has been made. Attached are the two pages affected by the change with the necessary revisions incorporated. These pages may be inserted into the TSCA §5 ERP in the appropriate places. If you have any questions concerning the revi sions please contact David Stangel of my staff at 382—3477. Attachments ------- ADDRESSEES Mike Shapiro (TS—788) Charles Elkins (TS—792) Frederick F. Stiehi (LE-l34) Mark Greenwood (LE-132A) A.E. Conroy II (EN-342) Diane Beal John J. Neylan III Mike Wood David Dull Jerry Stubbs Phyllis Flaherty Bob Zisa Sherry Sterling Maureen Lydon “ Ken Kanagalingam Jan Bearden Jake MacKenzie Western Regional Compliance Director Dean Hill, NEIC I Louis F. Gitto, Director Marvin Rosenstein, Chief Air Management Pesticide & Toxic Subs. Br II Barbara Metzger, Director Ernest Regna, Chief Environmental Services Div. Pesticides & Toxic Subs. Br Ill Thomas C. Voltaggio Larry Miller, Chief Acting Director Toxic 6 Pesticides Branch Hazardous Waste Management Division IV Winston A. Smith, Director Richard DuBose, Chief Air, Pest. & Toxic Mangt. Pesticides & Toxic Subs. Br Division V William H. Sanders III, Dir Phyllis Reed, Chief Environmental Services Div Pesticides & Toxic Subs. Br VI William B. Hathaway, Dir Robert Murphy, Chief Air, pesticides & Toxic Subs. Pesticides & Toxic Subs. Br Division VII William A. Spratlin, Dir Carl Walters, Acting Chief Air and Toxics Division Pesticides & Toxic Subs. Br VIII Irwin L. Dicketein, Director Alvin Yorke, Chief Air and Toxics Division Toxic Subàtances Br ------- —2-- IX David P. Howekamp, Director Davis Bernstein, Chief Air Management Division Pesticides & Toxic Subs. Br X Gary O’Neal, Director Kenneth Feigner, Chief Air and Toxics Division Pesticides & Toxic Subs. Br cc: Michael Walker (LE—134P) Jim Willis (TS—788) Alicia Tenuta (A—107) ------- tO Sr 41 , UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASH INGTON D.C. 20460 4 L PRO1 ’ MAY 15 1981 OFFICE OF PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM SUBJECT: Final Enforcement Response Policy fo CA J..L FROM: John J. Neylan I II, Director Policy and Grants Division Office of Compliance Monitori TO: Addressees Attached is the final revised Enforcement Response Polcy (ERP) for TSCA § 8, 12 and 13. The final ERP remains very similar to the proposed ERP issued on March 27, 1987 with changes made in three areas. Failure to maintain TSCA §8(c) records in a manner that meets the standard required in the rule has been made a sig- nificant, level 3, one—day violation ($10,000). The second change made is the addition of a violation for failure under the TSCA §8(a) Inventory Update Rule to keep records showing that the manu- facturer Is not subject to reporting. under the rule (major, level 6, $2,000). The third change to the ERP is a modification in the per day assessment for violations of TSCA §8(a) Chemical Specific rules. The per day assessment is now the the base penalty divided by 360. The maximum penalty for failure to report is now $34,189, while the maximum penalty for late reporting Is $12,067. This ERP supercedes the previous TSCA § 8, 12 and 13 ERP and Its two succeeding amendments. I would once again like to thank the Regions for their comments and cooperation in formu- lating this ERP, especially the Regional participants In the workgroup. If you have any questions concerning this final ERP, please contact David Stangel of my staff at (FTS) 382—7825. A discussion of the comments is attached. Attachments ------- Addressees Charles Elkins Frederick F. Stiehi Stanley Abramson Ken Shiroishi Phyllis Flaherty John Martin John J. Neylan III Ralph Turpin Mike Wood Gerald Stubbs Dexter Goldman Michael Walker Margaret Rostker Michael Stahl (TS-792) (LE-134A (LE-1 32A (EN-342) II SI II II II II (LE—134P) (TS-788) (TS—788)(Asbestos documents) Jake Mackenzie Western Regional Compliance Director A. Charles Lincoln Eastern Regional Compliance Director Louis F. Gitto, Director Air Management Division, Region I Barbara Metzger, Director Environmental Services Division, Region II Stephen R. Wassersug, Director Hazardous Waste Management Division, Region III Winston A. Smith, Director Air, Pesticides and Toxics Management Division, Region IV William H. Sanders III, Director Environmental Services Division, Region V William B. Hathaway, Director Air, Pesticides, and Toxics Division, William A. Spratlin, Director Air and Toxics Division, Region VII Irwin L. Dlcksteln, Director Air and Toxics Division, Region VIII Jeffrey Zellkson, Acting Director Toxics and Waste Management Division, Gary O’Neal, Director Air and Toxics Division, Region X Region VI Region IX Regional Pesticides and Toxic Substances Branch Chiefs ------- RESPONSE TO COMMENTS Comment: The penalties for TSCA §8(a) Chemical Specific reporting are too high and should be assessed as a one-day penalty in the same way that Inventory violations are handled. Re ponse: The Office of Compliance Monitoring and the Office of Toxic Substances feel very strongly that penalties for TSCA §8(a) CAIR and PAIR violations be higher than those for TSCA §8 Inventory violations. In most cases, the Agency is asking for the informa- tion under very strict statutory or court imposed deadlines and the information is used to determine how the Agency will regulate a chemical substance. The failure to report data in a timely man- ner could sertpusly impair the decision to regulate a chemical substance. We are, however, sensitive to the Region’s concerns regarding the amount of the penalties. The ERP, therefore, has been amended to reduce the amount of the per day penalty by di- viding the base penalty by 360 instead of 180. This would re- suit in a maximum penalty for failure to report violations of $34,189, with $12,067 being the maximum assessed for late report- Ing. Both OTS and 0CM feel that while the penalties are higher than those in the previous ERP, they are appropriate and shall remain per day violations. Comment: The TSCA §8(a) Inventory Update penalties are too high con- sidering that many of the violators will probably have multiple violations, due to Ignorance of the regulations. Response: While we agree that there may be Instances where a manufac- turer is ignorant of the regulations, these instances should not dictate the penalty structure. The Inventory Update Rule Is con- structed In such a way that most small manufacturers (the group most likely to be ignorant of the rule) are exempt from reporting. In the event that a manufacturer fails to report on a large num- ber of substances, the size of the business may mitigate the pen- alty or the company could undertake other activities to mitigate the penalty. If a large manufacturer fails to report on a large number of substances, a substantial harm may have occurred to the Agency’s efforts to characterize exposure and the penalties would be appropriate. ------- —2— Comment: The penalty policy is inconsistent in that a failure to re- cord TSCA §8(c) allegations at all is categorized as a significant, level 1 violation ($17,000) while a company that does keep allega- tions but fails to keep them in the manner prescribed is assessed a major, level 2 violation ($20,000). Response: We agree that this situation is inequitable. The ERP has been amended so that a failure to maintain TSCA §8(c) records in a manner that meets the standard required in the rule would be a significant, level 3, one—day violation ($10,000). There may be instances of a failure to maintain records or reports in a manner that meets the standard required in other rules so the violation will be reflected as both a level 2 and a level 3 vio- lation. The ERP distinguishes between TSCA §8(c) records and other records. Comment: The ERP should incorporate some method of employing gross market share/volume categories when determining penalties. Response: The workgroup has discussed a number of methods of factoring market share or volume into the penalty calculations and has not been able to develop a workable system to incorporate these para- meters into hazard assessment. Basically, the workgroup does not believe that harm can be related to market share. Other problems with such an approach are accurately determining market share, dealing with those chemicals where the Agency is concerned with very small amounts of a substance, and the potential for divulging confidential business information. - Comment: The current system of referring TSCA §13 cases to the Region where the Importer Is located rather than allowing the Region where the entry, and subsequent violation, occurred to take the case is inequitable. Response: 0CM agrees that Regions where the majority of importation occurs bear a much greater resource burden without receiving pro- per recognition for the resources expended. We are reluctant to once again amend the SPMS reporting system to include information on referrals to other Regions. We propose to include this infor- mation on the PC Tracking System and have these referrals be re- flected in workload modeling. ------- —3— Comment: Regions should charge brokers with violations of TSCA §13 as a means of acheiving compliance with the import regulations. Response: This office is deeply concerned with the practice of bringing actions against a broker as a means of reducing the number of ISCA §13 violations. The regulations at 40 CFR 707.20 require the im- porter to certify compliance with TSCA for all chemical substances Imported. The Importer is clearly the responsible party regard- less of the type of contractual arrangement the importer may have with the broker. It is the responsibility of the importer to do business with responsible brokers. While we agree that brokers are responsible for many of the violations that occur and a tech- nical assistance program would be of great benefit to educate the brokers, the importers are ultimately responsible for compliance with TSCA notwithstanding the actions of their agents. An Importer may wish to recover damages from a broker after the Agency has concluded its civil action, but that is a matter for which the Agency has no concern. National policy requires that civil ac- tions be directed to the importer of record. Questions have been raised as to the legality of directing any type of enforcement actions towards the broker which 0CM and OECM are attempting to address. Regions may wish to consider an educational campaign for those brokers who commit violations of TSCA §13, along with an informal warning letter to the broker stating the violation. Comment: Headquarters should reconsider the policy of concurrence for all cases settled under the new ERP, especially those taken under TSCA §13. Response: This ERP was revised in part to answer the concerns of the Regions that the penalties under the old ERP were unrealistically high and based mainly on when EPA conducted an Inspection rather than the potential harm that could have occurred. We feel that these concerns have largely been answered by this document. While the penalties assessed under this ERP will generally be less than those In the past, we are concerned that penalties may be reduced as they were in the past. We feel that the differ- ences between the penalty assessed and the penalty collected should be much smaller under this ERP than in the past. We are more concerned with penalties under TSCA §8, but feel It would be beneficial to monitor the penalties assessed for all ------- —4 — violations under this ERP. We anticipate relaxation of con- currence for TSCA §13 violations to be forthcoming after re- viewing the actions taken under this ERP. However, given the wide disparity in how the Regions administer actions under TSCA § 8, 12 and 13 at this time, we feel that requiring con- currence as a means of administering the new ERP is prudent. Comment: 0CM should distribute drafts of ERPs to the Offic&s of Re- gional Counsel as well as the Regional program offices. Response: At the insistence of the Office of Enforcement and Compliance Monitoring (OECM), drafts of ERP’s are directed to that office with OECM being responsible for transmitting these documents to the ORC. ------- MAY 151987 RECOROKEEPING AND REPORTING RULES TSCA SECTIONS 8, 12 AND 13 ENFORCEMENT RESPONSE POLICY OFFICE OF COMPLIANCE MONITORING OFFICE OF PESTICIDES AND TOXIC SUBSTANCES THE U.S. ENVIRONMENTAL PROTECTION AGENCY ------- Reporting and Recordkeeping Rules Enforcement Response Policy CONTENTS Ir troduction Summary of Requirements/Rules Covered. . . . . . . . . . 1 Determining the Level of Action Notice of Noncompliance . . . . . . . . . . . . . . . . 3 Administrative Civil Penalty . . . . . . . . . . . . . . 3 Injunctive Action . . . . . • • • • • • • • • • • • • 4 Criminal Sanctions . . . . . . . . . . . . . • • • • • • 4 Multiple Remedies . . . . . . . . . . . . . . . . . . . 5 Assessing an Administrative I ena1ty Summary of the Penalty Policy . . . . . . . . . . . . . 6 Explanation of the Penalty Policy . . . . . . . . . . . 16 Appendix 1: Caps for Per Day Vio at1ons Appendix : Examples ------- INTRODUCTION Section 8 of the Toxic Substances Control Act (TSCA) author- i zes EPA to require chemi cal manufacturers, importers and pro- cessors to keep records and to report certain information. TSCA §12 requires the submission to EPA of information about chemical exports. The TSCA §13 rule requires the submission of certifica- tion statements concerning import shipments of chemical substances. These reporting and recordkeeping provisions have similar types of requirements, and therefore, similar types of violations. For this reason, this Enforcement Response Policy addresses all these provisions as ISCA reporting and recordkeeping requirements. Failure to comply with the recordkeeping and or reporting provisions of TSCA is a violation of TSCA § 15(3)(A) and 15(3)(B) and subject to the remedies in TSCA §16. Summary of Requirements/Rules Covered TSCA §8(a) Inventory — Required reporting during 1977 by persons who manufactured and/or imported reportable chemicals. (At this date, these violations are most likely failures to report or falsified reports.) (40 CFR 710) TSCA §8(a) Inventory Update - Requires reporting by persons who manufacture or import chemical substances which are on the TSCA Chemical Inventory in quantities greater than 10,000 lbs. at a specific site. Small businesses and certain classes of chemicals are excluded. (51 FR 21438, June 12, 1986, 40 CFR 710) TSCA §8(a) Preliminary Assessment Information Reporting Rule ( PAIR ) — kequires reporting by persons who manufacture or im- port listed chemicals in quantities greater than 1,100 lbs. per site. Small businesses are excluded. (47 FR 26992, June 22, 1982, 40 CFR 712) TSCA 8(a) Asbestos Reporting — Required reporting by persons who mined, manufactured, imported, or processed asbestos by November 1, 1982. Exemptions included small businesses, dis- tributors, and builders. (47 FR 33198, July 30, 1982, 40 CFR 763) TSCA §8(a) Chemical Specific Rules ISCA §8(a) P-TBBA, P-TBT, P-TBB - 40 CFR 704.33 ISCA §8(a) Chlorinated naphthalenes - 40 CFR 704.83 TSCA §8(a) Chlorinated terphenyl - 40 CFR 704.85 TSCA §8(a) Hexachioronorbornadiene — 40 CFR 704.142 TSCA §8(a) 4,4’-methylenebis(2-chloroanhline)(MBOCA) — 40 CFR 704.175 ------- -2- TSCA §8(a) Polybrominated biphenyls (PBBs) — 40 CFR 704.195* TSCA §8(a) Iris (2,3—dibromopropyl) phosphate - 40 CFR 704.205 * These rules have been “sunsetted” and replaced by SNUR’s. TSCA §8(c) Alleged Significant Adverse Reactions — Requires persons who manufacture, import, process, or distribute chem- ical substances or mixtures in commerce to keep files of alle- gations of significant adverse reactions and provide this in- formation to EPA upon request. Exemptions include persons whose activities consist of mining or other solely extractive functions; processors who are not also manufacturers if none of the processors’ sites are engaged in activities described in IC 28 or S IC 2911; and persons who are solely distributors or retailers. (48 FR 38178, August 22, 1983, 40 CFR 717; amended 50 FR 46766, November 13, 1985, 40 CFR 717) TSCA §8(d) Health and Safety Studies Submission-. — Requires persons who manufacture, import, process, or propose to manu- facture, import, or process listed chemicals to submit lists or copies of unpublished studies to EPA. (47 FR 38780, September 2, 1982, 40 CFR 716 amended September 15, 1986, 51 FR 32720) TSCA §8(e) Substantial Risk Reporting — Requires persons who manufacture, import, process, or distribute in commerce a chem- ical substance or mixture and who obtain “new” information which reasonably supports the conclusion that such substance or mix- ture presents a substantial risk of injury to health or the en- vironment to report such information to EPA within 15 days. (Policy Statement, 43 FR 11110, March 16. 1978) TSCA §12 Exports — Requires persons who export chemicals subject to final and certain proposed rules and orders under sections 4, 5, 6 and 7 of TSCA to notify EPA of the country of destina- tion the first time a chemical is shipped to that country during a calender year. (45 FR 82844, December 16, 1980, 40 CFR 707.60) TSCA §13 Imports — Requires persons who import chemical sub- stances to certify that each shipment is in compliance with TSCA or is not subject to TSCAS (48 FR 34734, August 1, 1983, 19 CFR 12.118 through 12.127 and 127.28 amended, and 40 CFR 707.20) Future TSCA §8 Rules — This policy also covers all future rules promulgated under TSCA §8 or amendments to the above rul es. ------- -3— DETERMINING THE LEVEL OF ACTION Enforcement alternatives include a notice of noncompliance, a civil penalty, injunctive relief, criminal action, or some combination of these actions. Notice of Noncompliance A notice of noncompliance (NON) is appropriate where: (1) the violation is a first-time violation of ISCA § 12 or 13 where there are no other TSCA violations for the shipment or (2) minor violations of TSCA §8 as specified below where the violator has not received a previous NON for a violation of that particular subsection. Violations of TSCA §8 which warrant NON’s are: o Minor technical omissions, I.e., failure to supply required noncritical information (such as, the phone number of a technical contact). o FaIlure to use certified mail in making a notification (as required by a rule); o Report sent to Incorrect address but correctly Identified as a TSCA §8(_) submission; o Report sent to correct address but not identified as a TSCA §8(_) submission; Administrative Civil Penalty An administrative civil penalty will be the appropriate response for most violations of these regulations. Concu rrence Civil penalties are to be assessed according to this policy. Regional enforcement personnel must obtain written concurrence from the Office of Compliance Monitoring of the Office of Pesti- cides and Toxic Substances prior to Initiating a civil adminis- trative penalty for TSCA § 8, 12 and 13. Reductions for settle- ment purposes require the concurrence of 0CM as well and must be in accordance with the TSCA Penalty Policy and this ERP. ------- -4 - Each reduction must be justified in the consent agreement and final order and specific dollar amounts attributed to each re- duction. Headquarters may relax concurrence requirements on a Region by Region basis after the Regions have gained experi- ence with actions under these rules and the ERP. Injunctive Action Injunctive action under TSCA may be appropriate in certain circumstances. Although §17 of TSCA can be a very effective tool in obtaining compliance, it is also more resource inten- sive than a civil penalty action. In addition, it has been the Agency’s experience that a civil penalty action is usua1ly sufficient to obtain compliance. For these reasons, the Agency believes that the use of ISCA §17 remedies generally should be limited to those instances where a civil penalty action will not result in sufficiently swift compliance to protect human health or the environment. For example, injunctive action may be used to require a company to maintain records where the atti- tude of the violator indicates that this would not be done otherwise or where there is a repeated history of failure to keep records. Criminal Sanctions Criminal sanctions pursuant to TSCA l6(b) are the most serious sanctions available for violations of the recordkeeping/ reporting rules. Accordingly, criminal sanctions may be sought in situations that —— when measured by the nature of the conduct, the compliance history of the subject(s) or the gravity of the health or environmental consequences —— reflect the most serious cases of misconduct. Several factors distinguish criminal cases from administrative or civil actions. First, criminal sanctions will ordinarily be limited to cases in which the prohibited conduct is accompanied by evidence of “guilty knowledge” or intent on the part of the prospective defendant(s). TSCA imposes criminal penalties only for violations of the Act which are committed “knowingly or willfully”. A second factor to consider is the nature and seriousness of the offense. As a matter of resource allocation, EPA will inves- tigate and refer only the most serious forms of misconduct. Of primary importance to this assessment is the extent of environmental contamination or human health hazard that resulted from, or was threatened by, the prohibited conduct. Also of significance is the impact, real or potential, on EPA’s regulatory functions. ------- —5- Third, the compliance history of the individual(s) or per- son(s) for a potential criminal case is important. Criminal sanctions become more appropriate as incidents of noncompliance increase. While not a prerequisite, a history of noncompliance will often indicate the need for criminal sanctions to achieve effective individual deterrence. Multiple Remedies There may be unusual instances where a particular situation will present facts that suggest that more than one final action should be taken. 0CM does not encourage the use of multiple re- medies for the reasons discussed below. The purpose of this Section is to outline when multiple remedies are appropriate. Criminal Sanctions Simultaneous civil and criminal enforcement proceedings are legally permissible, United States v. Kordel , 397 U.S. 1 , 11 (1970), and on occasion are clearly warranted. These cases should be the exception rather than the rule. When parallel proceedings are contemplated, please refer to the Office of En- forcement and Compliance Monitoring guidance on parallel proceed- ings (January 23, 1984). Notice of Noncompliance In general, a notice of noncompliance should not be used in conjunction with any other final remedy. Where a particular situation presents several violations, some of which would merit a notice of noncompliance, while others would merit civil penalties, no notice of noncompliance should be sent. Instead, an adminis- trative penalty action should be initiated, pleading all viola- tions, with no penalties for minor infractions which would other- wise warrant an NON. Civil Administrative Penalties and Specific Enforcement The criteria outlined in this section antIcipate that civil penalties and specific enforcement (injunctive action) will be used sequentially. There may, however, be instances where the concurrent use of these remedies is appropriate. If the Region deems this to be appropriate in any case, It should consult with 0CM and OECM before bringing either action. ------- -6- ASSESSING A CIVIL ADMINISTRATIVE PENALTY Summary Backgro of thiPenaIty Policy und The TSCA Civil Penalty Policy, published in the Federal Register on September 10, 1980, establishes a system tor deter- mining penalties in administrative actions brought pursuant to TSCA §16. Under that system, penalties are determined in two stages: (1) determination of a “gravity based penalty” (GBP), and (2) adjustments to the gravity based penalty. To determine the gravity based penalty, the following factors affecting a violafion’s gravity are considered: o The nature of the violation. o The “extent” of environmental harm that could result from a given violation. o The “circumstances” of the violation. These factors are incorporated in a matrix which allows de- termination of the apppropriate gravity based penalty. Once the gravity based penalty has been determined, upward or downward adjustments to the penalty amount are made in con- sideration of these other factors: O Culpability, o HIstory of such violations, o Ability to pay, o Ability to continue in business, and o Such other matters as justice may require. The TSCA Civil Penalty Policy system provides a framework for the development of individual penalty guidances for each rule promulgated under TSCA. This document sets forth Agency policy for the use of the GBP Matrix to assess penalties for specific violations of TSCA § 8, 12 and 13 and regulations promulgated pursuant to these sections. ------- —7— Applicability ___________ ______ This policy is immediately applicable and should be used to calculate penalties for all administrative actions concern- ing TSCA § 8, 12 and 13 instituted after the date of this policy, regardless of the date of violation. Pending cases should be reviewed to determine whether the penalty calculated under this policy is lower than the penalty in the civil complaint. If this policy yields a lower penalty, an amendment to the com- plaint should be made to substitute the lower penalty. This policy should not be used to raise penalties in existing actions. Plo case should be settled for an amount higher than the penalty which this policy wouldyield. Calculation of the Gravity Based Penalty Penalties for TSCA § 8, 12 and 13 violations vary depending on tne extent, circumstances, whether penalties are to be calcu- lated as one day assessments versus per day assessments, and by capping the number of days for which a violation may be assessed as appropriate. In establishing each of these, the Agency con- sidered the following factors in a comparative manner: o Impact on the Agency’s decision making process. o Relative degree of harm caused by failure to comply. o Timeframes In which the Agency decision making process generally occurs. o Time to generate information not reported. O Relative costs of studies. O Likelihood that sufficient information is available from other sources. ° Type of information involved, i.e., human exposure versus animal toxicity studies and allegations versus actual data. The Gravity Based Penalty (GBP), a function of the nature, circumstances and extent of each violation, is to be determined by using the following matrix: ------- -8- EXTENT A B C CIRCUMSTANCES Levels 1 High Range 2 MAJOR SIGNIFICANT $25,000 $17,000 $20,000 $13,000 MINOR $5,000 $3,000 3 Mid Range 4 $15,000 $10,000 $10,000 $6,000 $1,500 $1,000 5 Low Range 6 $5,000 $2,000 $3,000 $1,300 $500 I $200 After determining the initial or ubase penalty” from the ma- trix for the first day of violation, add the penalty for each addi- tional day of violation based on the instructions in the “Penalty for Each Day of Violation” heading. Whether a penalty is to be assessed as a one day assessment or as a continuing violation on a per day basis Is included in the Circumstances sections. Days of violation are based on calender days, not workdays. Nature A violation may be either chemical control, control-asso- ciated data gathering, or hazard assessment in nature. For pur- poses of assessing a penalty, the nature of a recordkeeping/ reporting violation is “hazard assessment.” Cl rcumstances The first step in selecting the base penalty is to deter- mine which level on the circumstances axis applies to the violation. The circumstances axis of the GBP matrix reflects the probability that harm will result from a particular violation. For recordkeeping and reporting rules, violations rank as fol- lows on the circumstances axis: ------- -.9- CIRCUMSTANCE LEVE l. LEVEL I Nonreporting for TSCA §8(e) Per day Nonreporting for TSCA §8(e) Emergency One day Incident of Environmental Contariination Nonreporting for TSCA §8(d) Per day Nonreparting for TSCA §8(c) Per day Nonreporting for TSCA §8(a) Chemical Per day Specific Rules Nonreporting for Inventory Update One day Nonreporting for Inventory One day Failure to keep records [ not TSCA §8(c)] Per day* Failure to record ISCA §8(c) allegation One day False/incorrect/misleading reporting Per day* LEVEL 2 Failure to maintain records/report in a One day manner that meets the standard required in the rule. TSCA §8(c) violations are level 3. Failure to report under TSCA §8(d) involving One day omission of study in list of studies which a manufacturer or processor knows of but which is not in his possession. LEVEL 3 Failure to report completely after EPA has Per day* requested missing information or a correc- tion of erroneus Information. Failure to maintain TSCA §8(c) records/ One day report In a manner that meets the standard required in the rule. Assess one violation where all allegations are filed but not in the manner presribed. TSCA §13 VIolation (first or otherwise) One day where a positive/negative/no certification was submitted but the chemical does not com- ply with other TSCA provisions. LEVEL 4 Late reporting — For definition of late Per day* reporting parameters, see the Compliance Monitoring Strategy for each rule. Does not apply to the original Inventory Rule, TSCA §12 and TSCA §13. TSCA §12 violations after company has One day received a previous notice of noncompliance for a violation of TSCA §12. ------- -10- TSCA 13 violations where a negative/no cer— One day tification is suhmitted but the chemical is subject and chemical is in compliance with all other TSCA provisions as specified in the TSCA §13 regulation and the company has received a previous notice of noncompliance for a violation of TSCA §13. LEVEL 5 No violations are level 5. LEVEL 6 Minor technical omission - Example: omitted One day name of technical contact but included title and phone number so the Agency was able to reach the correct person. (See Notice of Noncompi lance.) TSCA §8 report sent to incorrect office and One day was not identified as a TSCA §8(_) submis- sion as required. TSCA §8 report sent to incorrect office and One day was identified as a ISCA §8 report after company has received a previous notice of noncompliance for a violation of the same subsection. TSCA 8 report sent to correct office but One day not identified as a TSCA §8 report after company has received a previous notice of noncompliance for a violation of the same subsecti on. Failure to keep records showing that the One day manufacturer is not subject to reporting under the TSCA §8(a) Inventory Update Rule. Extent The second step in selecting the base penalty for a specific violation from the matrix Is to determine Its position on the extent axis. This axis of the GSP matrix reflects the extent of potential harm caused by a violation. In the case of recordkeeplng/reporting rules, harm is defined as the inability of the Agency to carry out its risk assessment responsibilities under TSCA. * One day for Inventory update, Inventory, TSCA §12, TSCA §13, TSCA §8(e) ETEC’s, and TSCA §8(d) involving lists of studies which a manufacturer or processor knows of but which are not in his possession. ------- —11— EXTENT LEVEL MAJOR Violations of ISCA § 8(c), 8(d), or 8(e) which involve information which directly interferes with the Agency’s ability to address situations involving potential imminent hazard, unreasonable risks, or substantial endangerment to health or the environment.* Violations of TSCA § 8(d) and 8(e) involving human data. Violations of TSCA §8(e) involving Information on emergency incidents of environmental contam— ination (EIEC). All Circumstance Level 2 violations. All Circumstance Level 6 violations. SIGNIFICANT Violations of TSCA § 8(d) and 8(e) involving animal/aquatic studies, environmental monitor- ing, workplace monitoring (not invasive human monitoring), and any other study not addressed in the major or minor extent level. Violations of CAIR, PAIR, TSCA §8(a) chemical specific rules, TSCA §8(c), Inventory, and Inventory Update Rule except Level 2 or Level 6 violations. Violations of TSCA §12. Violations of TSCA §13. MINOR Violations of TSCA §8(d) involving physical/ chemical properties or environmental fate data. * This determination must have written concurrence from OPTS. ------- —12— Per Day Assessments Where per day assessments are provided for in the Circum- stances Level section, the base penalty is calculated for the first day of violation and per day penalties are assessed for each subsequent day of violation based on the following formula: Violations Involving Potential Imminent Hazard/Substantial Endangerment Si tuati ons/Un reasonable RI sks Base X Each day of violation = Penalty Penalty TSCA §8(e ) Base + ( No. of days of violation — 1) x base penalty = Penalty Penalty 30 TSCA §8(a) Chemical Specific _( Base + ( No. of days of violation — 1) x base penalty = Penalty* Penalty 360 All others Base + ( No. of days of violation — 1) x base penalty = Penalty* Penalty 180 * The number of days of violation cannot exceed caps as designated in the following section. Caps on Number of Days for Penalty to be Assessed Per Violation TSCA §8(e) No cap TSCA §8(d) 5 year cap Major Extent Violations 3 year cap Significant Extent Violations 1 year cap Minor Extent Violations ISCA §8(c) 1 year cap TSCA §8(a) 1 year cap Chemical Spec i fic PAIR 1 year cap CAIR 1 year cap ------- —13— Determining Number of Violations — Multiple penalties are to be used if there is more than one violation of the same rule or violations of different rules. Violations will be determined as follows: ISCA §8(a) ISCA §8(a) TSCA §8(a) TSCA §8(a) TSCA §8(a) Rules Inventory Inventory Update PAIR CAIR Chemical Specific Per Chemical Per Chemical Per Site Per Chemical Per Site Per Chemical Per Site Per Chemical (Per Chemi- cal Per Site if Site—Spe- cific Reporting Is Re— qul red) Per Allegation Submitted to Company and Not Filed Per Requirement Not Met Per Firm Per Allegation Not Reported Per Study Per Chemical Per Type of Reportable Effect or Event Per Chemica 1 TSCA §8(c) Failure to Keep Records TSCA §8(c) Failure to Keep Records as Required TSCA §8(c) Report TSCA §8(d) TSCA §8(e) TSCA §12 Per Chemical Per Coun- try Per Year TSCA §13 Per Shipment Per Port ------- -14- Determining the Gravity Based Penalty The circumstances level and the extent category for each violation will define a base penalty in the matrix. For those violations designated as per day in the circumstances matrix, calculate the penalty as indicated under per day assessnents, taking into account the caps on the number of days the penalty is to be assessed. This total penalty should be entered on line 1 of the TSCA Civil Penalty Assessment worksheet and adjusted by the appropriate factors discussed in the TSCA Civil Penalty System and this policy. Adjustment Factors The TSCA Civil Penalty System discusses appropriate adjust- ment factors. In addition, adjustment factors specific to this policy are discussed below. Voluntary Disclosure (Other Factors as Justice May Require ) The ERP establishes fixed percentage reductions in penal- ties for voluntary disclosure of violations for the following sections only: TSCA §8(a) Inventory Rule, TSCA §12, and TSCA §13. For all other sections, the voluntary disclosure of a violation is to be treated as a late report, and therefore, the violator receives a substantial reduction since the circumstance level moves from Level 1 to Level 4. For TSCA § 8(a) Inventory Rule, 12 and 13, the adjustment factors for voluntary disclosure Is as follows: Disclosure . ............................ 25% Immediate disclosure within 3Odays of discovery ...................25% TOTAL 50% The Agency will not consider disclosure voluntary if the company has been notified of a scheduled inspection or the inspection has begun. Information received after these events will be considered as failure to report/file. However, if, for example, an inspector is conducting a TSCA §8 inspection at an establishment, and the company voluntarily discloses a TSCA §13 violation and the inspector would not have any expectation of discovering such a violation, the TSCA §13 violation would be considered to be voluntarily disclosed. This example would also apply to TSCA §12 violatIons. For TSCA §12 and §13 violations, if a company discloses addi- tional violations during or prior to settlement negotiations, those violations are eligible for voluntary disclosure reduc- tions. The Region may deal with this situation through: ------- -15— 1) an amendment to the original complaint; 2) an additional complaint; or 3) addressing additional charges in the Consent Agreement and Final Order. Economic Benefit In no case should the final penalty imposed be less than th.e economic benefit. In those cases where the initial penalty is less than the economic benefit derived from noncompliance, EPA reserves the right to impose per day penalties up to $25,000 per day to assure that the penalty is not less than the economic benefit. Exposure Reduction (Other Factors as Justice May Require ) In cases warranting per day assessments of the base penalty, i.e., those involving potential imminent hazard, etc., if the — Respondent has credible evidence by affidavit which shows, for example, exposure has ceased by all routes of exposure, environ- mental and/or commercial; that evidence may be considered to mitigate the penalty. In those cases, the penalty will be as- sessed at the maximum base penalty per day during the duration of the exposure presenting Imminent hazard/substantial endanger- ment/unreasonable risk and assessed as a violation not presenting the potential hazard/risk/endangerment during the time that the hazard/risk/endangerment had ceased to exist. Attitude For TSCA §13 violations, if the company had a system in place to track import certifications and comply with TSCA §13 requirements, and a chemical “slips through”, a 15% good attitude reduction may be given as provided for in the ISCA Penalty Policy. Larger reductions are inappropriate in that companies are required to comply with certification require- ments and credit should not be given for attempting to comply with the law. If a company experiences numerous occasions where chemicals uslip through” their system, a good attitude reduction Is no longer appropriate. History of Previous Violation The Agency will disregard the . firm’s prior history of violations in calculating the penalty for a self-disclosed violation. However, for violations discovered by the Agency, the Agency will address history of prior violations as indi- cated in the TSCA Penalty Policy, even If the prior history results from a violation which was voluntarily disclosed. ------- -16- Explanation of the Penalty Policy Nature _________ _________________ TSCA § 8 and 12 require that information concerning chemicals be reported to EPA or kept at the company and made available to the Agency. TSCA 13 requires importers to certi- fy that chemicals imported are either not subject to TSCA or are in compliance with TSCA. Section 8 informatIon is used by the Agency to evaluate the potential risks associated with the manufacture and use of a chemical. This data gathering often occurs at the early stages of regulatory decision making. Therefore, complete and accurate information is essential. Incomplete and inaccurate information will have far—reaching effects on the Agency’s risk assessment, regulatory priority setting, and regulation development processes. Some information Such as TSCA §8(e) information may affect the Agency’s ability to init tate immediate action necessary to pro- tect health and the environment, e.g., seeking injunctive relief. In addition, reports under the original Inventory Reporting Rule establish the basis for what is an “existing” chemical versus a “new” chemical, the latter being those for which a premanu— facture notice must be filed and the chemical reviewed by the Age n cy. Section 12 collects information about the export of chemicals subject to certain proposed or final testing or regulatory require- ments under TSCA § 4, 5, 6, or 7. The Agency provides this infor- mation to the government of an importing country to allow that country to initiate its own risk assessment process. The section 13 rule describes procedures for certifying that Imported chemical substances subject to TSCA are In compliance with TSCA. This information permits the Agency to determine if importers of chemicals are complying with applicable TSCA regula— ti ons. Circumstances The circumstances axis of the GBP matrix reflects the probability for harm resulting from a particular violaton. For the reporting rules, the potential harm caused is the harm to the Agency’s regulatory program for controlling health and environmental risk. For violations of the original Inventory Reporting Rule, the potential harm is that a new chemical may be produced with no prior review contrary to the Intent of TSCA because an Inventory Rule violation resulted in a chemical being placed on the Inventory which was not an “existing” chem- ical under TSCA. For chemicals which other persons also reported, the harm deals with the information on the estimated produc- tion volume and sites of manufacture which the Agency uses In its risk assessments, Including those for TSCA §4 test rule decisions. For section 12 reportIng, the potential harm is ------- —17— to the Agency’s ability to carry out its responsibility to notify other countries. Thus, violations have the potential to also harm another country’s regulatory program. High Range Violations — Level 1 Nonreporting/failure to report or to keep records is an extremely serious violation of these rules. The Agency will have to proceed with chemical assessment and priority setting, and perhaps, even regulation development, especially for TSCA §4 test rules, without critical information or without the knowledge that such informaton even exists. This is true even if a company reports some information but does not report each study or under— reports the extent of health effects or number of allegations for a particular effect. Thus, each report omitted or incompletely reported will be treated as a separate nonreporting violation. False/incorrect/misleading reporting of information is equal iy harmful because the Agency is misled in its analysis of the potential risks posed by the chemical or in the amounts or types of information available. TSCA §8(c) violations in level 1 include failure to keep records and failure to report if the Agency has requested that the information be submitted. Thus, if a company has received TSCA §8(c) allegations, but does not maintain TSCA §8(c) records, and the Agency requests that TSCA §8(c) allegations be submitted and the company fails to make a submission, there are two viola-. tions - one for the failure to keep records and another for the failure to report. Even if a company submits most allegations but not all, each failure to submit an allegation shall be separately charged and assessed as a failure to report. TSCA §8(d) level 1 violations include the following: — Failure to submit unpublished studies in the manufacturer’s, importer’s or processor’s possessi on. — Failure to notify EPA of unpublished studies the manufacturer, Importer or processor knows of but is not in possession of. - Failure to notify EPA of ongoing studies which the manufacturer, Importer or processor Initiated or sponsored. Includes future studies required to be reported once they are initiated. — Failure to send EPA the final report of a study which was listed as an ongoing study. Includes future studies required to be submitted. ------- -18- — Failure to submit underlying data to EPA on EPASS request. Failure to comply with the TS(A §8(e) repnrting requirements is potentially the most serious violation of TSCA §8. TSCA §8(e) reports alert the Agency to new information which may have a hearing on the Agency’s regulatory efforts. This ERP reflects th seriousness the Agency attaches to violations of TSCA §8(e) by placing no caps on the penalties assessed for these violations. High Range Violations — Level 2 Failure to maintain records or report in a manner that meets the standard required by the rule has effects similar to falsi- fied information. Both mislead the Agency nd are difficult to detect. Failure to report in a manner that meets the standard refers to those cases where reporting is essentially complete and the missing/incorrect information does not impact the report in such a manner as to mislead the Agency. An example is the failure to report one ongoing TSCA §8(d) study when another similar study is reported by the company. Another example is a small error in reporting production volume, i.e., less than an order of magnitude (a factor of 10). Level 2 also includes a TSCA §8(d) violation involving the failure to report a study which a manufacturer knows of but which is not in his possession. The Agency considers this violation to have less potential harm than other failure to report violations since the Agency is likely to learn of this study from other persons reporting. Mid Range Violations - Level 3 Failure to report completely after EPA has requested missing information is a significant violation. Such a violation denies the Agency access to information necessary to its analysis of chemical risks. This type of violaton is not as serious as the high range violations because It is usually relatively easy to detect and therefore easy to remedy. A form, for instance, will have blank spaces where answers are expected. Even though the Agency does not have the information, it knows that an information gap exists, and therefore, is less likely to be misled into making invalid chemical risk assessments. However, the withholding of information is a serious Impediment to risk assessment, and if it becomes a widespread practice, It could significantly affect the Agency’s chemical risk assessment processes. Thus, this vio- lation, while not as serious as a total failure to report or false or misleading reporting, is still of sufficient severity to be treated in the higher level of the midrange. ------- -19- For ISCA §8(c) files, the failure to maintain reports as required in the rule, e.g., files which are present but which are not cross—indexed or which are not kept in one location, in- volves a level 3 violation. in those cases where the company files this information, and the Agency requests the information to be submitted, and information is not submitted because the company’s files result in the information not being discovered during the company’s file search, the failure to submit is a level I viola- tion. The company may also be charged with the level 3 violation. Please note that failure to file an allegation under TSCA §8(c) although other allegations are filed constitutes a level 1 failure to keep records violation. Another level 3 violation involves TSCA §13 violations where there is a positive/negative/no certification and the chemical is in violation of other TSCA provisions. TSCA §13 is designed to assure that an importer takes affirmative responsi- bility in assuring that his shipments comply with TSCA. Where other TSCA violations are found, a level 3 violation will be assessed plus appropriate penalties for the other TSCA violations. Mid Range Violations - level 4 Reports which are late can significantly slow or disrupt the Agency’s decision making process. The exact timing nay vary on a rule by rule bas1 which will be discussed In the Compliance Monitoring Strategies. lateness is classified In the lower level of the midrange circumstances category. in addition, the Agency has decided to treat reports which are submitted late as late reporting regardless of the date of submission, with the exception of reports for the original Inventory Rule and TSCA § 12 and 13. This decision has been made to encourage the voluntary disclosure of violations by assessing penalties as level 4 Instead of level 1. For the original Inventory Rule and ISCA § 12 and 13, a reduction is provided for the voluntary disclosure of violations. Reports submitted or violations disclosed after EPA has notified a company of a scheduled Inspection will be treated as level 1 failure to report violations, except as otherwise Indicated in the Summary of the Penalty Policy. TSCA §12 violations other than the first violation are categorized as level 4. The Agency considers TSCA §12 report- ing to be important to its ability to notify other countries to which chemicals subject to TSCA rulemaking are being exported. The potential harm Is not to the Agency’s decision making process but to its statutory obligation to notify other countries. ------- -20- The Agency considers TSCA §13 violations, other than the first TSCA §13 violation for which there are no other TSCA viola- tions, to be mid range level 4 violations. Even if no actual harm occurs, the violation reflects the importer’s failure to assure full compliance with TSCA. Failure to certify or filing a false certification on each shipment circumvents the purpose of TSCA §13 and could lead to the importation of chemicals which violate other provisions of TSCA. Low Range Violations - Level 6 There are no violations which fall within level 5. level 6 violations include minor technical omissions which do not affect the Agency’s ability to follow up the information either by contacting someone in the company or consulting outside references. They are among the least serious because the violation is readily detected, does not affect initial risk assessment and may only slightly hinder the Agency’s decision making process. In cases where there is no effect on the Agency, a notice of non- compliance rather than a penalty may he appropriate. However, if a company repeats this type of violation, the Agency will assess a penalty. Another level 6 violation is the failure on the part of a manufacturer to keep records showing that he Is not subject to reporting under the TSCA §8(a) Inventory Updat Rule, which requires persons who produce less than 10,000 lbs. of a sub- stance to maintain records documenting that fact. Other low range violations include a submission of TSCA §8 information which is not identified as TSCA §8(_) information and which is not sent to the correct office. Also, submitting the information to the incorrect office or not correctly identifying the information after a previous Notice of Noncompliance has been issued for a violation of that section warrants a level 6 assessment. Although the Agency receives the information, it may take some time to reach the correct office or to be placed into the review process, and therefore, the Agency’s decision making is delayed or impeded. Extent This factor reflects the extent of potential harm to EPA’s hazard/risk assessment process. The Agency relies on information gathered under sections 8(a), 8(c), 8(d), and 8(e) to perform risk assessments. The Agency uses TSCA § 12 and 13 in a different way. TSCA §12 information is used in order to notify foreign governments. ISCA §13 is used to assure that Importers verify and certify compliance with TSCA. ------- —21— For risk assessment, information may be related to toxi- city or exposure, both important in determining risk. In examining the extent of potential harm, the type of information •is important, i.e., human effects data, human exposure data, animal data, environmental effects, actual environmental con- tamination information. Also, scientific studies versus allegations differ in their importance. Major Extent Violations which directly interfere with the Agency’s ability to address potential imminent hazard, unreasonable risk, or substantial endangerment to health/environment are placed in the major extent category. This criteria is appli- cable to TSCA 8(c), 8(d), and 8(e). Examples of these types of violations include: 1) information on injury to humans where continued manufacture or use poses a potential imminent hazard; or 2) information on a spill/dumping which is covered by TSCA §8(e) and which posed(s) an imminent hazard or results in widespread environmental contamination to which persons. exhibit serious health effects. In the second case, two violations would be charged, one for the failure to report the spill and another for the failure to report the health effects. Other major extent categories include TSCA § 8(d) and 8(e) violations involving information on human effects. Such infor- mation can weigh heavily in the Agency’s decision making process. Also, violations involving emergency incidents of environ- mental contamination reportable under. TSCA §8(e) are considered to be of major extent since the Agency needs such Information immediately. Otherwise, the opportunity to. provide adequate protection may be lost. All level 2 and level 6 violations are placed in the major extent category. Significant The Agency places slightly less importance on animal studies as opposed to data reporting effects in humans. Nonetheless, such information is critical to the Agency’s decision making process. Such tests may be expensive, may take a long time to ------- —22- conduct, and require rulemaking by the Agency to obtain them. For example, if a company fails to report a study it has, the Agency may decide that such data are needed and proceed to do unnecessary rulemaking under TSCA §4. Given the time for such rulemaking and the time needed to conduct tests and submit re- sults to the Agency, the violation results in a major delay in the Agency’s risk assessment of the chemical and an unnecessary expenditure in resources, both EPA’s and industry’s. Please note that failure to report a study which is required to be re- ported but which indicates no adverse effects of the chemical still results in this harm. The Agency has also decided to place violations involving exposure related data in the significant category when the EPA has made a decision that it needs such information for a specific chemical. Thus, TSCA § 8(d) and 8(e) violations involving exposure related information as well as violations of the CAIR, PAIR, and TSCA §8(a) chemical specific rules,- all of which involve exposure related information, are consid- ered to be significant category violations. Although exposure information is critical to any risk assessment, the impact on the Ageny’s decision making if one company fails to report and all other companies comply is less than if one company fails to submit a toxicity study since It is less likely that another company will submit the same study. This distinction is reflected in the establishment of caps for different types of violations. TSCA §8(c) involves allegations and not actual test data. However, such information is important to the Agency’s decision making process in that it Involves patterns of effects and generally involves human effects. Therefore, these violations are categorized as significant. TSCA §8(a) Inventory and Inventory Update Rules are also designated as significant. Although information under these rules is not required as a result of the Agency Identifying a specific need for information on specific chemicals, this information provides exposure related information which is important to the overall decision making of the Agency in terms of setting its priorities and deciding what rulemaking to pursue. TSCA §12 violations are also considered significant since such information is necessary for EPA to carry out its responsi- bility to notify other countries of chemicals for which EPA has taken certain actions, i.e., a TSCA §5 order or a final or proposed TSCA § 4, 5 or 6 rule. TSCA §13 is significant in that violations hinder EPA/Customs’ ability to monitor ship- ments for compliance with TSCA. ------- -23- Minor Two types of violations fall into the r’iinor extent level, i. ., violations of TSCA §R(d) involvinq physical/chemical properti s r environmental fate data; and violations of TSCA §8(a), failure tn keep records showing that a manufacturer is not suhject to reporting under the Inventory Update Rule. The ISCA §8(d) violations are categorized as minor based on the relatively low costs of such studies and the time it takes for the study to be conducted. The TSCA §8(a) violations are easy to detect upon inspection and information the company should already have. Per Day Penalties or One Day Assessments The Agency has elected to use one day assessments for violations of rules which require reporting for all chemicals meeting certain criteria (such as exceeding a given production volume per site) as opposed to information which is not being requested on a chemical specific basis. In other words, one day assessments are appropriate in cases where the Agency uses the information to set priorities and may use it as the need arises on a specific chemical evaluation but has not affirma- tively identified a particular chemical for which specific information is needed. In those cases where EPA has issued a rule which lists a specific chemical(s), per day assessments are appropriate because the Agency has identified a need for the information for risk identification, risk assessment, or risk management purposes. Per day assessments also apply to any TSCA §8(e) information (except ETEC’s which do not meet the potential imminent hazard/ endangerment criteria). Although the information is not being requested for a specific chemical, it is likely to be used immediately for risk assessment purposes. Per day assessments are made for those violations where the continuing violation continues to impede the Agency’s decision making process. One day assessment is appropriate for a failure to list a TSCA §8(d) study which a company knows of but which is not in Its possession. Level 2 and level 6 vIolations are to be as- sessed as one day. Also, TSCA § 12 and 13 are considered to be one day violations. As with TSCA §8(e) violations dealing with an EIEC, violations of these rules do not impede the Agency’s regulatory decision making process in that such infor- mation would not normally result In rulemaking. However, such information is necessary for more immediate actions such as Injunctive relief or seizing chemicals which are otherwise in violation of ISCA, e.g., a TSCA §13 chemical imported in viola- tion of TSCA §5. Violations Involving TSCA §8(c) fIles, i.e., failure to record information, are treated as one day violations because the effect on the Agency’s decision making is not critical ------- -24- until the Agency requests the submission of TSCA §8(c) informa- tion. Once the information is requested, the Agency has a specific need for the information to make its decisions. There- fore, “failure to report” violations under TSCA §8(c) are as- sessed on a per day basis due to their adverse impact on the Agency’s decision making. Per Day Assessment Calculation For violations involving ISCA §8(e) information which directly interferes with the Agency’s ability to address situations in- volving potential imminent hazard, unreasonable risk, or substan- tial endangerment to health/environment, the base penalty is to be assessed for each day of violation. These are the most serious violations, and therefore, warrant the highest penalties provided for by the statute. For other TSCA §8(e) violations, the base penalty is to be used for the first day of violation. For each day thereafter, the per day penalty is the base penalty divided by 30. This ad- justment was selected for the following reasons: 1) these viola- tions involve significant adverse effects; 2) the Agency has an immediate need for the information in order to protect the pub- lic and environment, as reflected in the statute’s language to “immediately notify”; and 3) the timing of the Agency’s decision making process once such data is received. For TSCA § 8(c) and (d) violations for which per day assess- ments are to be made, the base penalty is to be used for the first day of violation and for each day thereafter, the per day penalty is the base penalty divided by 180. For TSCA §8(a) Chemical Spe- cific violations the per day penalty is the base penalty divided by 360. ThIs method was selected in order to provide further distinction between types of violations and their impact on the Agency’s decison making process and its mission to protect the public and the environment. Caps In establishing caps for some violations, the Agency took into account factors such as the length of time that a violation continues, the timing of the Agency’s decision making process, the relative costs of studies and the length of time needed if unnecessary studies .are conducted. Please note that the cap does not refer to a limitation on the time elapsed since the violation occurred — only a limit on the number of days for which a penalty Is assessed even though a violation continues for a longer period. There Is no cap on TSCA §8(e) violatIons. The harm continues as long as the violation continues. For TSCA §8(d) studIes, which often relate directly to TSCA §4 rulemaking, the caps depend on the type of study, the length of time to conduct the study, the relative costs of the studies, and the timing of the Agency’s decision making. ------- -25- For other TSCA §8 violations for which per day assessments are to be made, a one year cap is set based on the estimated time of the Agency’s decision makiny process. This decision also reflects the fact that TSCA §8(a) requirements are more exposure on ented than toxicity oriented, and therefore, the quality of the information is sensitive to time. As indicated in the discussion on extent categories, exposure information is important but one company’s failure to report may not have as much of an impact as nonreporting of toxicity information because the exposure information is used in the context of total exposure. Therefore, these violations are capped at one year. A chart is provided in Appendix I which indicates the caps per violation and their maximum assessments. Caps refer to maximum penalties for each separate violation; they are not cumulative caps for multiple violations. Determining Number of Violations The number of violations depends on the requirements which are in each rule. Multiple violations are to be assessed when- ever more than one rule is violated and for each violation within a rule. TSCA §8(a) Inventory violations are assessed for each chemical for which there is a violation. The Inventory Update rule requires reporting for each chemical and for each site. Therefore, TSCA §8(a) Inventory Update violations are assessed per chemical per site. Violations of CAIR and PAIR are assessed per chemical per site. TSCA §8(a) Chemical Specific Rules violations depend on the information required by the rule. If the rule requires site specific information, then violations are assessed per chemical per site. If the rule requires aggregate information for each company, then violations are assessed for each chemical not reported/otherwise in violation. TSCA §8(c) violations are determined depending on the viola- tion. TSCA 58(c) “failure to keep records” violations and “failure to report” violations are assessed per allegation not malntained/ reported. This is because the omission of any allegation may impact the Agency’s decision making process, especially If there is significant underreporting of allegations. However, a “failure to keep records as required” under TSCA §8(c) is assessed per plant site because these violations involve files not maintained as prescribed but for which the information is available. An alle- gation consists of each report (i.e., one or more pieces of paper) whereby an Individual! group submits an allegation to a company. If one person alleges that six chemicals produced ten effects In the same report, and the company fails to file the allegation, this is assessed as one violation. If two persons file separate reports regarding the same health effect, and the company does not file the allegations, this constitutes two violations. If ------- -26- a union files a report for 100 persons regarding an allegation, and the company does not fi1e the allegation, this is assessed as one violation. • TSCA §8(d) violations are assessed for each required study. The omission of a single study even if others are submitted may have a serious impact on the Agency’s decisions regarding a specific chemical. TSCA §8(e) violations are assessed per type of effect per chemical not reported. Omission of one significant adverse effect even if other effects are reported impedes the Agency’s risk assessment. TSCA §12 violations are assessed per chemical per country per year not reported. This decision was based on the determina- tion that the export notification requirement Is a one-time requl rement per year for each chemical and for each country of export. That is, the first time a chemical is exported to a country, the exporter must notify the country. Subsequent exports of the same chemical during the same calendar year to the same country do not require notification. TSCA §13 violatIons are assessed per shipment per port because the u .S. Customs regulation requires a certification for each shipment, not for each chemical within a shipment. If the same chemical is imported on the same day to a port in three separate shipments, there are three violations. Adjustment Factors Voluntary Disclosure The Agency considers It important to foster voluntary disclosures of violations for TSCA § 8, 12, and 13. Most dis- closures of TSCA §8 violations will be treated as late reporting and subject to level 4 instead of level 1 penalty assessments, which provides a voluntary disclosure incentive. For TSCA §8(a) Inventory violations and TSCA § 12 and 13 violations, explicit reductions for voluntary disclosure are also provided. It is important to foster voluntary disclosure of TSCA §8(a) Inventory violations in order to remove chemicals from the Inventory which were placed there illegally. Once the Agency knows of this, It it can act to correct the violation. Similarly, if violations of TSCA § 12 and 13 are brought to the Agency’s attention, it can act to remedy the situation, e.g., foreign countries can be notified or imports in violation of other sections of ISCA can be identified and appropriate action taken. Also, EPA wants to encourage companies to conduct self- audits and report violations. ------- —27— History of Noncompliance — ___ As a further incentive for the voluntary disclosure of violations, the Agency has decided to forego the imposition of penalty increases for a previous history of noncompliance in assessing penalties for voluntarily disclosed violations. However, a voluntarily disclosed violation does constitute a history of violation and is to be used to increase penalties for future violations which the Agency discovers. TSCA Section 13 — Who Issues Notice of Noncompliance/Penalty and to Whom TSCA §13 may involve imports in one Region by an importer of record, who is located in another Region and who uses a broker. The Notice of Noncompliance/Penalty is to be issued to the importer of record, not the broker, and by the Region in which the importer of record is located. This is consistent with the Inspection Guidelines. This decision was made for several reasons. If a TSCA §5 inspection is conducted at the importer of recordss business, and there Is a chemical which has been Imported into three ports In three other Regions and which Is not on the inventory, it is more efficient to Issue a Civil Conplaint for the one TSCA §5 vio’ation and three TSCA §13 violations than to issue four sep- arate Civil Complaints in four Regions. A second reason pertains to the location of the hearing. If one Region issues the complaint to an importer of record in another Region, there is a problem of travel , both in terms of time and money, since the hearing will likely be held in the Region where the importer of record is located. A third reason deals with the tracking of Notices of Non- compliance between Regions in order to know if a company has received its first TSCA §13 Notice of Noncompliance and Is therefore subject to penalties for subsequent violations. ------- APPENDIX 1 CAPS FOR PER DAY VIOLATIONS ------- CAPS FOR PER DAY VIOLATIONS ALL CAPS ARE PER VIOLATION TSCA §8(e ) - No Caps TSCA §8(d ) Nonreporting/Fal Major, level Sign I ficant, Minor, level Late Reporting Major, level Significant, Minor, 1 eve1 se Reporting 1 — level 1 — 1 — 4 level 4 4 $278,333 - 5 yr. cap $120,322 — 3 yr. cap $15,111 — 1 yr. cap $111,333 — 5 yr. cap $42,467 — 3 yr. cap $3,022 — 1 yr. cap TSCA 8(c ) Nonreporting/False Reporting Significant, level 1 — Late Reporting - 1 yr. cap Significant, level 4 — — 1 yr. cap $51 ,378 $18,133 TSCA §8(a) Chemical Specific rules Nonreporting/False Reporting Significant, level 1 — Late ReportIng— 1 yr. cap Significant, level 4 — — 1 yr. cap $34,189 $12,067 ------- APPENDIX 2 EXAMPLES ------- EXAMPLES TSCA §8(a) Chemical Specific Rules (PAIR, CAIR, Asbestos, etc. ) Example 1 — A company fails to report. EPA discovers the violation. Failure to report, level 1, significant. Discovered after 181 days - $25,500 $17,000 + 180 X $17,000 = $25,500 360 Discovered after 361 days - $34,000 Discovered after 1,095 days — $34,189 (1 yr. cap) Example 2 - A company reports late. Late report, level 4, significant. Report 181 days late — $9,000 $6,000 + 180 X $6,000 = $9,000 360 Report 271 days late - $10,500 Report 730 days late - $12,067 (1 yr. cap) Example 3 — A company reports under the rule. EPA later discovers that the Information was falsely reported. False reporting, level 1, signifIcant. Discovered after 181 days — $25,500 $17,000 + 180 X $17,000 = $25,500 360 Discovered after 361 days - $34,000 Discovered after 1,095 days - $34,189 (1 yr. cap) Example 4 - A company reports under the rule. The company later reports that some of the information was inaccurately reported and supplies EPA with the correct information • within 10 days. Late reporting, level 4, significant. Reported 181 days late — $9,000 $6,000 + 180 X $6,000 = $9,000 360 Reported 365 days late - $12,067 Reported 1,825 days late — $12,067 (1 yr. cap) ------- —2— TSCA §8(a) Inventory and Inventory Update Example 1 — A company fails to report a chemical on the TSCA Inventory. EPA discovers the violation. Failure to report, level 1, significant, one—time penalty. Failure to report — $17,000 Example 2 — A company fails to report a chemical on the TSCA Inventory. The company is bought by another company who, upon checking records, discovers the failure to report and immediately notifies the Agency. Failure to report, level 1, significant, one—time penalty. Failure to report - $17,000 Voluntary Disclosure Policy — 50% reduction of penalty. Amended Penalty - $8,500 Example 3 - A company falls to report 1 chemical at 4 dif- ferent sites for the Inventory Update. The company is bought by another company who, upon checking records, discovers the failure to report and immediately notifies the Agency. Late reporting, level 4, significant, 4 counts, one—time penalty. Late reporting, 4 counts - $24,000 TSCA §8(c ) Example 1 — A union contacts EPA complaining that they submitted 1 report to the company regarding health effects to 10 workers due to their exposure to chemical X. The report was presented to the company In accordance with the rule, and the union provided acknowledgments of receipt by the company. EPA requested the company to provide all allegations of health effects due to exposure to chemical X. The company failed to respond. EPA inspected the com- pany’s TSCA §8(c) fIles six months later and found none. Failure to keep flies, level 1, sIgnificant; and failure to report, level 1, significant. $17,000 + $17,000 + 180 X $17,000 = $51,000 180 Failure to maintain a file $17,000 Failure to report (per day penalty) $34,000 181 days ________ Total 51,000 ------- -3— Example 2 - EPA requested a company to submit any al- legations of effects attributable to chemical V. The company reported that no allegations of effects of any kind were made to them. An inspector visited the com- pany 2 years later and found a file for chemical V which included 3 allegations of bird kills attributed to the chemical. Failure to report, level 1. significant, 3 counts. $17,000 + 364 X $17,000 x 3 = $154,134 180 Failure to report - (1 yr. cap) — $154,134 Example 3 — EPA requested a company to submit any al- legations of effects attributable to chemical V. The company reported that no allegations of effects of any kind were made to them. A year later they contacted the Agency and informed us that they just found 4 old al- legations of human effects attributable to chemical V and submitted the allegations within 10 days. Late submission, level 4, significant, 4 counts. $6,000 + 360 X $6,000 x 4 = $72,000 180 Late reporting — 361 days x 4 - $72,000 Example 4 — An Inspector visited a company and asked to see the company’s TSCA §8(c) files. The company informed the inspector that any allegations by workers were kept in the Individual workers personnel files. Failure to keep files in a manner prescribed by the rule, level 3, significant, one day assessment, no per day penalty. $10,000 Example 5 — An inspector visits a company and when inspecting their TSCA §8(c) file discovers that the files are organ- ized by the health effect rather than by the cause of the health effect. The files are otherwise in compliance with the rule. Failure to keep files in a manner prescribed in the rule, level 3, signIficant, one day penalty. $10,000 ------- -4 — TSCA §8(d ) Example 1 — A company submits a list of ongoing studies they are sponsoring but fails to list a study involving humans. EPA discovers the violation. Failure to report, level 1, major. Discovered after 365 days — $75,556 $25,000 + 364 X $25,000 = $75,556 180 Discovered after 1,095 days — $176,944 Discovered after 2,000 days — $278,333 (5 yr. cap) Example 2 — A company submits late an animal study in the company’s possession during the initial reporting period. Late reporting, level 4, significant. Reported to EPA after 365 days — $18,133 $6,000 + 364 X $6,000 = $18,133 180 Reported to EPA after i,095 days - $42,467 Reported to EPA after 1,825 days — $42,467 (3 yr. cap) Example 3 - A company submits an animal study, EPA finds ad- ditional reportable information that the company intentionally omitted from the submitted study report. False reporting, level 1, significant. Discovered after 365 days - $51,378 $17,000 + 364 X $17,000 = $51,378 lop Discovered after 1,095 days — $120,322 Discovered after 1,825 days — $120,322 (3 yr. cap) Example 4 — A company submits a list of 9 ongoIng animal studies and later submits 10 studies. Late reporting of one study, level 4, signifIcant. Submitted to EPA 365 days after list submitted — $18,133 $6,000 + 364 X $6,000 = $18,133 180 Submitted to EPA 1,095 days after list submitted — $42,467 Submitted to EPA 1,825 days after list submitted — $42,467 (3 yr. cap) ------- —5— Example 5 — A company submits a list of studies known to them but not in their possession. The Agency discovers that the company failed to list a study they had knowledge of. Failure to report a study the manufacturer knows of but is not in his possession, level 2, major, one day assessment, no per day penalty. $20,000 CA §8(e ) Example 1 - A company failed to report a spill within the time period prescribed in the policy. EPA discovers the violation. Failure to report, level 1, major, one—time assessment — $25,000 Example 2 - A. company failed to report a spill within the time period prescribed in the policy. The company reports their failure to EPA a year after the spill occurs. Late reporting, level 4, major, one—time assessment — $10,000 Example 3 — A company fails to report a study showing human health effects. EPA discovers the violation. Failure to report, level 1, major. Discovered after 361 days — $325,000 $25,000 + 360 X $25,000 = $325,000 30 Discovered after 1,081 days - $925,000 Discovered after 3,601 days - $3,025,000 Example 4 — A company fails to report a study showing animal effects not previously reported. The company later submits it to the Agency. Late reporting, level 4, significant. Reported after 361 days - $78,000 $6,000 + 360 X $6,000 = $78,000 30• Reported after 1,081 days — $222,000 Reported after 3,601 days - $726,000 ------- -6— Example 5 — A company submits a study to EPA showing new animal effects. An inspector conducting an inspec- tion of the company later discovers reportable information which was omitted from the study. False reporting, level 1, significant. Discovered after 1,825 days — $1,050,600 $17,000 + 1,824 X $17,000 = $1,050,600 30 Discovered after 365 days — $223,267 Discovered after 3,650 days — $2,084,767 Example 6 — A company fails to submit human health effects information which is later characterized by the Agency as showing a potential imminent hazard. EPA discovers the violation 90 days after the report was due. Failure to report, level 1, major. Potential imminent hazard finding, $25,000 per day penalty. $25,000 X 90 = $2,250,000 EPA discovered the same violation after one year. $25,000 x 365 = $9,125,000 EPA discovered the violation after one year and the company presents credible evidence that exposure ceased after 90 days of the due date of the report. The penalty is calculated as an imminent hazard for 90 days and as a reduced per day for the TSCA §8(e) faIlure to report for the period thereafter. $25,000 X 90 = $2,250,000 275 X $25,000 = $229,167 30 $2,250,000 + $229,167 = $2,479,167 TSCA §12 Example 1 — An exporter which has received no previous TSCA §12 NotIce of Noncompliance exports 30 chemicals to 30 coun- tries with no notifications. Failure to notify. Notice of Noncompil ance. ------- —7— Example 2 — An exporter who has previously received a Notice of Noncompl lance for a TSCA §12 violation exports one chemi cal to one country 30 times during one calendar year with no notifications. Failure to notify, level 4, significant. — S6 ,000. Example 3 - An exporter who has previously received a Notice of Noncompliance for a TSCA §12 violation exports one chemical to one country 30 times during one calendar year, notifying EPA that 5 shipments had already occurred. Failure to notify, level 4, significant, voluntary disclosure, more than 30 days since discovery, 25% reduction. - $4,500 Example 4 - An exporter who has previously received a Notice of Noncompliance for a TSCA §12 violation exports the same chemical to 30 countries with no notifications within the same year. Failure to notify, 30 counts, level 4, signifi- cant. — $180,000 Example 5 — An exporter who has previously received a Notice of Noncompliance for a TSCA §12 violation exports the same — 30 chemicals to 30 countries with no notifications within the same year. Failure to notify, 900 counts, level 4, signifi- cant. — $5,400,000 TSCA Section 13 Example 1 - Company imports a chemical with no certification and which is otherwise in compliance with ISCA. Failure to certify, level 4, significant. First time violation: NON Second time violation: $6,000 Example 2 — Second time violator imports a chemical which is otherwise in compliance with ISCA at 3 ports on the same day but has no certification or an incorrect certification. Failure to notify, level 4, signifIcant, 3 counts — $18,000 Example 3: Second time violator imports 3 shipments of a chemical which Is otherwise in compliance with TSCA on the same day to the same port. Failure to notify, level 4, significant, 3 counts — $18,000 Example 4 - Second time violator imports 30 shIpments which are otherwise in compliance with TSCA but lack a certification. Import may be to same port or different ports. Failure to certify, level 4, signifIcant, 30 counts. $180,000 ------- 0 ------- 40 SP 4 p UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ‘I’, WASHINGTON, DC 20460 CERTIFIED MAIL RETURN RECEIPT REQUESTED 7 89 TO C SU8STANCES Mr. Blake A. Biles Jones, Day, Reavis & POgue 1450 G Street, N.W. Washington, D.C. 20005—2088 Dear Mr. Biles: Re: Olin Runt Specialty Products, Inc. This is in response to the meeting of March 29, and your letter of April 3, 1989, requesting the granting of prosecutoria]. discretion for the continued commercial use of a chemical sub- stance which may have been manufactured in violation of the Toxic Substances Control Act (TSCA). In the meeting, you voluntarily disclosed that Olin Hunt Specialty Products, Inc. had manufactur- ed several chemical substances which were not listed on the TSCA 8(b) inventory. In addition, one chemical substance purchased by Olin Hunt Specialty Products for research and development purposes was used by Olin Hunt Specialty Products for nonresearch and development purposes and incorporated into products used by Sheldahi, Inc. in Orange County, California. This chemical is subject to a low volume exemption request identified as L—89—82. As you are aware, EPA will initiate a proceeding for the assessment of a civil penalty against Olin Hunt Specialty Products, Inc. for violations of TSCA involving the manufacture and use of chemicals prior to their inclusion on the inventory. Uoon review of this matter and the facts stated in your letter of April 3, 1989 to Mary McDonnell, Office of Compliance Monitoring and the letter of Timothy H. Butler of Lindquist & Vennum of March 31, 1989 to Blake A. Bil .es, the facts of which we accept as accurate and upon which we are basing our decision, EPA has determined that the national interest would not be served by the temporary discontinuation of Sheldahi’s use of the chemical substance which is under review. The basis for this determina- tion is that: 1. The chemical substance used by Sheldahl has received an expedited risk assessment and was found not to present an unreasonable risk of injury to human health and the environment; and 2. The user of the chemical substance, Sheldahl, and its employees may suffer an economic hardship due to a lack of the chemical substance. ------- —2— Therefore from the date of this letter, Olin Hunt Specialty Products, Inc. and Sheldahi, Inc. will, be authorized to use the existing stocks of the chemical substance subject to the low volume exemption notice. Commencement of any additional manufac- ture may not resume until the low volume exemption review period has expired. No civil penalty will be assessed for the use of existing stocks of the chemical provided that each of the following conditions are met: 1. Olin Hunt Specialty Products, Inc. initiates immediate steps to ensure its compliance with TSCA and certifies that all of its future manufacturing of these chemical, substances is in full compliance with the provisions of the Toxic Substances Control Act; 2. Within 30 days, Olin Hunt Specialty Products, Inc. provides the Agency with all records pertaining to the manufacture, processing, use, and export of chemical substances in violation of TSCA as referenced in your letter of April 3, 1989, including batch, sales, purchase, and inventory records; 3. Within 30 days, Olin Hunt Specialty Products, Inc. provides a narrative description of the steps required to manufacture the chemical substances, the uses of the chemical substances, and the structure and properties of the chemical substances; 4. Within 30 days, Olin Specialty Products, Inc. provides a complete written description of the events which led to its dicovery of the violations and subsequent notification of the Environmental Protection Agency (EPA); 5. Olin Hunt Specialty Products, Inc. promptly provides any other documents or other information in the company’s possession which the Agency seeks pursuant to Section 11 of TSCA in order to prepare a civil administrative case for the violations of Section 15 of TSCA by Olin Hunt Specialty Products, mc; 6. Olin Hunt Specialty Products does not contest the EPA’s jurisdiction over the subject matter of the complaint which will be issued for the violations of Section 15 of TSCA as described in the first paragraph of this letter; and 7. Olin Hunt Specialty Products, Inc. certifies that the information which it shall supply to the Agency will be true, accurate, and correct. ------- —3— Please sign in the space provided below if you agree and consent to the terms of this letter. Upon receiving the letter with your signature, I will also sign this letter and the author- ization for the use of the subject chemical will begin in accor- dance with the, conditions set forth above. Sincerely yours, Michael F. Wood, Director Compliance Division s4/ “ Date SEEN AND AGREED TO: Blak’é A. Biles, Counsel Olin Runt Specialty Products, Inc. Date ------- p ------- SY4 1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 4 , 0 it - OFrICE 0 PESTICIOtS AND TOXIC SUOSTANCCS MEMORANDUM G I6 85- - SUBJECT: Sugarhouse Realty, Inc. FROM: Marcia E. Williams L J Deputy Assistant Administrator for Pesticides & Toxic Substances TO: Courtney M. Price Assi tant Administrator for Enforcement and Compliance Monitoring I have reviewed Region III’s findings concerning the trans- formers located at Jack Frost Sugar House, 1015-1021 Penn Street, Philadelphia, Pennsylvania. I concur with Region III that the presence of the PCB transformers and spilled fluid containing 13,000 ppm PCBe in an unBecured area constitute an imminent and substantial endangerment to the public health or welfare and that they present an imminent and unreasonable risk of serious. injury to health. I, ------- UNIThD STATES DISTRICT cØ FOR THI . ASL .RN DISTRICT OF L NNS’LLVANLA I I TPt . lATT R OL• ) ) UNIT D STATES OF AMERICA ) ) CIVIL AcTION NO. ) v. ) SU AItKOUSE REALTY, iNC. ) WiLLIAM h. THAYER ) JOSk .PIW4E ThAYER ) AFFIDAVIT CliRISTOPHI.R b. PILLA, Environmental Scientist 1 United States Environmental Protection Agency (EPA), Region III , bsii g duly seorn, deposes and says: 1. I am employed as an Environmsntal Scientist assigned to the TSCA/FIPRA Enforcement Section, Huardous Vests Enforcement Branch, tazardous JasLs Management Division, EPA Ragicu III. I as the polychlorinated biphenyl (PC$7” CospUance Monitoring Progras Coordinator and, u part of sy d ti.s, I as auchorisad by the Regional Mministrator of EPA, R.gion III, to conduct of tidal inve$ti$stion. and inspactiona pursuant to all Federal laws ad niat.r.d by EPA. ------- 3. AS 3 reSult ot 1nSpect ons and 1nv t1gac1on oX c c r. Jack ‘rosr Sugar House (the factLity) located at lOt5—ltJ’ L Penn Str :. Philedeiphia, Pennsylvania, the .PA baa deterin.tned that substantiat quantities ot the chemical substance known as polychlorlnated biphenyl(s) ( ‘CBa), a hazardous substance, and may in the future be spilled from equipment containing PCBa and that the PCBs are present in quantl:ie. and condition. which risk exposure to persona who may enter the facility. Despite EPA ’s efforts to obtain compliance with the statutory and regulatory requirements relating to PCBs and to obtain voluntary actions which would secure the facility to reduce or prevent human exposure., the facility remain. readily accessible to treepaseer., including cMldren. In light of these facts and clicumetances, on August 1.6, 1985, 2PA determined that conditions at the facility asy be an iaslnent and substantial endangerment to the public health and the environment pursuant to Section lOb of the Comprehensive Environmental Euponse, Compensation, and Usbility Act, 42 U.S.C. 1 9606 (“CERCLA). EPA ha. also determined that conditions at the facility present an unisasonabi risk from an imminently hasardouo chemical substance pursuant to Section 7 of the Tonic $ubst*nces Control Act, 15 U.S.C. I 260b ( TSCA ). * detailed chronology of EPA ’. actions respecting thi. facility and of the events leading to EPA’s determinations of imminent hazard are set forth in numbered patsgrspbs bs3ov. ------- 4. On April 1, l9 4, 1 r cei’n d an anony tuus i hone call COm crr the miehendling o po1ychiorinatc d biph nyi (PCB) çuipin c at th tormer Jack Frost Sugar 1Icus located at 1Ol5—lO l Penn Street, Philadelphia, Pennsylvania. . On April 9, 1984, 1 and Patricia Tan, also a duly authorized inspector with PA Legion Ill, inspected the old Jack Froet Sugar Rouse for compliance witt regulations promulgated pursuant to Section 6(e) of the Toxic Subetancee Control Act (TSCA). The facility is located along the bank of the Delaware River. 6. At the time of the April 9, 1984 inspection I observed ten out ot service PCI containing PCI transformers and three empty PCI contaminated transtormers. The PCI transformers were identified u PC by the PCI trad nsaes appearing on the nameplate to the transformers; namely, Pyrano]’, “Chlor.xtol, and NNOfl 11. b1. Liquid and the yellow PCI warning label. 1. At the ties of the April 9, 1984 PC) inspection, violations of the PCI transformer periodic visual inepactio and usocisted record— keeping requirements and the Annual Donusent Inventory requirements were dovusented. ------- 4 8. On ApriL 9, 1984, the tori er owner ot the racility reporc d the presence of 150 PCB capacitors at various locatiuns throughout the ac1ti;y 9. On November 8, 19b4, I received an anony oua phone call concerning the illegal scrapping of PCI transformers at the former Jack Frost Sugar House at 1.037 N. Delaware Avenue in PhiladeLphia. 10. On November 8, 1984, I and Roger Meyer a duly authorized Inspector with EPA Region III, of the Emergency Response Section of the Supertund kanch of EPA Region 111 inspected the facility. At the time we deter ine4 that the complaint was nor valid for the PCI transformers observed at that time. however, it was apparent that salvaging of the facility interior was occurring including non—PCI items located in the PCI transformer areas. ii, On November 14, 1984, I and Stephen Hirsch, a duly authorized inspector with the Environmental Services Division of EPA Region 111, inspected the facility to verity that all of the PCI transformers observed at the ties of the April 9, 1964 inspection had not been tampered with. None of the PCI tran.iorsers observed at the ties of the April 9, 1984 inspection bad been tampered with and no PCI had been spilled based on that inspection. It was apparent that dismantling of other metal—based non—PCI equipment was occurring. Welders torch.. were present. ------- 5 12. On November 11, j9 4, a TSCA admirtiatr c1vc co p1aint was Issued Co the owners of the tacility or violations o the PCØ regu1acion documented at the time of the April 9, 1984 PCB Inspection. 13. Durir g the period ot negotiating a acttlement with owners of the tacility, regarding the November 14, 1984 administrative complaInt it came to my attention that ownership of the facility had changed hands. 14. On January 10, 1985, 1 forwarded a lettet, certified sail, return receipt requested, to Mr. William Thayer, th. new owner of the tactilty, apprising bin of hi. reaposaibilitie. under the PCI regulations and the presenc. of PCI transformer, and PCI capacitore at th. facility. I also for’watded a copy of the PCI rsgulstions to his. Th return receipt cud was signed by an agent of Mr. Thsy.r on Jan isry 11, 1985. A copy of this letter Is attached hereto a. Ishibit A. 15. On July 2, 1983, 1 received an anonyu is phosa call that the PCb transformers at th. old Jack Prost Sugir Rouie had been veodalised and several gallon. of PCI. had been spilled. ------- 16. On JuLy 2, L 8 I acid Patr c1a tan inspe Led the racliity ac : tound that two PCB transforc era, serial. nuxbers l8 —I . 2 and l8 5—119, b artng th PCB tiuld tradenane “Chiorextol” and the yellow PCB werntc g label, had been vandalized such that the entire PCB fluid contents of both had been spilled (270 gallons each). I collected a composite auiple of the spilled fluid as witnessed by Patricia Tan, which was later analyzed ana found to contain, in excess of 13,000 parts p.r million (ppm) of PCBe. 17. On that aaz day, I observed another PC$ transformer which also appeared to have been vandalized. This tranaformsz serial number 101— 46— J, bore the yelLow PCB warning label and the PCU fluid tradename Non Flammable Liquid”. 1 witnessed a composite sample collected from a pool of liquid it the transfor5eT’I bass by Patricia Tan. I believe that a large large volume of the 670 gallons of fluid contained in this transformer iad leaked based on the sound made upon tapping the transformer. The sample of spills4 PCB was sualytid and found to contain in excess of 13,000 ppm of PCk. I received thi. analysis on August 13, 1983. 18. On July 2, 1985, I observed a winding which I believe vs. stripped from a piece of unidentified electrical equipment. Patricia Tan collected a sample of th. paper insulation from this winding which was later analyzed and found to contain £n excess of 250 ppm of PCBs. I iiitnes.sd lb. Tan’s collection of this sample. ------- 7 19. On July 2, l98 , I cc lL’ct d cor pc;1 cjirtldebr:s sa p iii an area removed irom the 1ocat on of che spi’ 1& : PCH and teak1: g PCb transEor s. Patricia Tan witnessed y coLlection of this sa p1e which was lacer analyzed and found to contain in exce of 70 ppm of Pt.. Is. 20. On July 2, 1985, 1. observed a sump located outside of the building housing the transformers, away Iron the general. vicinity of the PCI transforneru and spilled PCI.. The sump contained water and oil. I collected a sample ae witnessed by Patricia Tan which was later analyzed and found to contain in excsss of 14 ppm PCBa. 21. On July 2, 1985, 1 obierved that in general, since my initial inspection of ApriL 9, 1984, the condition of the PCI transformers •nd the facility had greatly deteriorated. Electrical equipment such as switch gear h d been vandalized, a d haphazardly strewn around the room where the VCI transformer. ar. located. 22. On July 2, 1985, 1 observed several persons on the site collecting scrap natal. Three of these persons were chi1drs . 23. On j,gy 2, 1985, 1 advised several contractors of the ner of the facility to stay away fro, the spilled PCI., and the PCI traoafoimer. for health and safety rsuons. ------- a 4. On July , 19S5, I m’ t with r. iLUe Thayer, the own the tacli4ty end his p rForr d environnental Cleanup contractor. I apprL ed Mr. mayer that the faciLity n ded to be secured, the C8 concaa.inatioii problem a isessed, and the PCIk cleaned up. Mr. Thayer agreed to these measures. It b’C.5 agreed that I would forward Mr. Thayer a letter contirining our meeting and his comm.ttment to address the spilled PCI. and dormant PCI equipment and to secure the facility, to which Mr. Thayer would respond in writing. 2 . On July 16, 1985, 1 forwarded a letter to Mr. mayer confirming our meeting ot July 8, 1985 describing EPA’. concerns, and what needed to be done to address the PCI situation. I requested a written response to that letter by JuLy 23, 1985. A copy of this letter is attached hereto u nhibit I. 26. During the period of July 25, 1985, to August 8, 1985, 1 made a number of calls to Mr. Thayer’s office requesting a response to my JuLy 16, 1933 letter, and a statue report regarding th. PC) situation at his facility. Mr. Thayer was not available for these calls except for one. Mr. Thayer acknowledged recsipt of my letter during this on. ‘conversation. I told Mr. Thayer chat I n..d.d a response in vritin$ and that I intinded to visit the site to obeerve what progress had been asda. Mr. Thaysr reported that a 24 hour guard was now on duty at th. facility, and that plan, had been finalized to have flood lights and a fence •rected. During one of the calls prior to the one with Mr. Thayer the woman I talked to, which I bell.,, is Mr. thayer’s secretary, also acknowledged receipt of my July 16, 1983 letter. ------- 9 Z7. cm Itu u t i, 19?,5, I visited the site ound tit) guard 1 re ent, aud the t.icility accessible Co Cha public since there is — eftective phys cai barrier to prevent access. I observed through the window-Ot a snail room at the northwest corner of the facility a sign for a guard. The sign—in log bore the name Kuma—K 9 Security . .c. The log indicated that a guard had signed In on August 6 and 7 at 4:30 p.m. and signed out at 12:00 p.m. For August 7, 1985, th, log stated that some one got into the building. For August 8, 1985, th. log stated that made tour around plant, one door in back. of building was open and one door in front was op.nH. I also spoke with a Phila— delpMa Police Otticer who stated that the facility had been burglarized that morning. 28. On August 13, 1985, 1 received the analytical result. for the - sample. Collected on July 2, 1985 from kPA’s Central Regional Laboratc in Annapolis, Maryland. Thus sample results are listed in previous paragraphs. 29. On August 14, 1983, I and St.phsn Jarvela, a duly authorised On Scene Coordinator in the Ergency Response Section, of lbs Haurdoua Waite Managensel Division, IPA Region III inspected the old Jack Frost Sugar h as. to determine whether the condition of ths PC$ transfot ti and the presenc. of spilled PCIe constitutes an I nent and .u tantial eodsngernt to the public hesith, welt are and the envirou nt. 30. On August 14, 1985, 1 chewed Stephen Jarvela the location of spilled PCI. and the vandaUsed PCI trs..formsrs from which the PCIS had spilled. I showed Mr. Jarvela the associated electrical •qnipmsnt which had b.e. v.ndalissd. ------- 10 31. iollow1n my and Mr. Jarve1a’ tour or the facility, Mr. Jarvela reported to oe that he would recommend chat PA deter CI; c the COndition of the PCB transfurners, and the spilled PCS Iluid, posed an lnm.tnent and substantial endangerment to the public hcalth, welfare and the eflvtronment with the threat to the public being one of direct contact exposure and possible entry of PCBs into groundwater and the Delaware River. 32. on August 15, 1985, 1 accepanied Edward T. Ellis the Assistant United States Attorney repruenting EPA, to the •ite of the facility in order to familarize him with the circumetancee of this sitter. On that visit, I observed that conditions were as I had found them on August 14. In addition I observed that PCS transformer serial number P1885-179 had developed a leak and vu now dripping on the concrete floor. At the tims of our arrival and during ths courss of our visit of approximately thrity minutes there was no guard present at the facility and there was no affective barrisr to prevent access. 33. On August 16, 1985, the Regional Msinistruor f or EPA, Raglan LI!, pursuant to duly delegated authority, determined thn the circumetsocas at the facility may be an imminent sod •ubst aitial endsugerm.nc to th, public health or wslfare or the snviromesnr and thu they present an imminent and uoreasonsbls risk of serious or widespread injury to h•alth or the euviro nt. Copiss oS the Regional Mministrator’s determinations are attached hereto u Exhibit C. GERISTOPIIU: 5. PILL& - - Enviromesut.]. Scientist Subscribed and Sworn to me this ___ day of 1983. . ------- a COVER SHEET FOR TELECOPIER 4ESSAGES DArE:________________ TO: 2 4 Ltt 0 llOY,1 f’1 1/ L DESK PHONE: jFG PROM: Y)luI&&1II fllA4L4& t . DESK PHONE: 5cpf 09?S TOTAL $ 0? PAGES(NOT including cover 3heet) — /0 TELECOPIER TELEPHONE $, EPA REGIOM III ____ _________ ------- 0 ------- U.S. ENVIRONMENTAL PROTECTION AGENCY REGION X 1200 SIXTH AVeNU! SSATTL . WASHINGTON 9! tot Office of Pegicrial Cou sel, MIS 613 S This letter advises you that the s rn interview of yourself currently being conducted by this Agency ha. not been cc.pleted, and you are required to return to this offic. for cc p1ee1cn of that interview at the fotI.owttig t1 e On thi following date: D t: DAX OF WE 1C: We iL1]. make sincere efforts to caitp].ete the interview on that date, and m regret that our duties require that inconvenience you further in thi matter. Your indulgence and patience with our efforts uld be apprecia- Sincerely, If have any questions concerning this matter, please contact ne, at 442—1275. Assistant Regional Cou se . HPIT 10 *ITN OP to ted. 000009 Page 1? ------- § 1001. Whoever, in any matter within the Jurisdiction of any department or aiency of the United SLates knowinhly and willfully falsifies. COfl• c.al or coven up by any trick, scheme. or device a material fact, or makes any false. fictitãous or fraudulent statements or repre1snta tions. or makes or uses any false writing or document knowing the same to contain any falae, fictitious or fraudulent statement or entrY. shall be fined not more than $10000 or imprisoned not more than five years. or both. June 25. 1941. c. 645. 62 Stat. 749. Page 18 ------- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ) In the MatterOf: ) ) PILOT CHEMICAL COMPANY, spondent. ) ) ) ) Docket No. TSCA—87-H—12 SUBPOENA AD TESTIFICANDUM AND SUBPOENA DUCES TECUM SUBPOENA AD TESTIFICANDUM AND SUBPOENA DUCES TECUM TO: AUBREY M. KIRBY, JR. Sun Refining and Marketing Company Ten Penn Center 1801 Market Street Philadelphia, PA 19103-1699; RESPONDENT TO THE SUBPOENA YOU ARE HEREBY COMMANDED, pursuant to the provisions contained in Title 15, United States Q,de, Section 2610(c) (Toxic Substances Control Act Section 11(c)J, and 40 Qde of Federal Regulations Section 22. 33(b), TO ATTEND AS A WITNESS at the hearing in the above—captioned administrative enforcement action to testify regarding your Affidavit of July l0 ’, 1987, hereto attached and to be offered into evidence by Complainant U.S vironmenta1 Protection Agency at the hearing, AND PRODUCE AS DOCUMENTARY EVIDENCE all documents (as defined below) which you relied upon in preparing the aforesaid ffidavit, at the fo11owin dates, times, and places: DATES AND TIMES: November 8, 1988 ____________________ November 9, 1988 PLACE: Los Angeles, California — ( Specific location to be determined - contact Bessie L. Hammiel, Hearing Clerk, Office of Administrative Law Judges, at (202) 382—4865 for further information ] YOU ARE COMMANDED FURTHER: TO BE AND APPEAR IN PERSON, with all the documents identified above, before Administrative Law Judge J. F. Greene at the above dates, times, and place; TO TESTIFY then and there upon oath and MAXE TRUTHFUL RESPONSE to all lawful inquiries and questions then and there put to you by the Parties to the proceeding; and TO REMAIN IN ATTENDANCE until expressly excused by Administrative Law Judge Greene. 2:00 p M — 500 P M. 9:00 A.M. — 5:00 P.M. ------- —2— DEFINITION For purposes of this SUBPOENA, the word “documents” means all’ written, typewritten, handwritten, printed, or graphic matter of any kind or nature, h iever, produced or reproduced (including any copies containing additional matter), any form of collected data for use c ith electronic data processing equi nent, and any mechanical or electronic visual or sound recordings including, without limitation, all tapes and discs, n or formerly in your possession, custody or control. It includes, but is not limited to, any logs of materials or containers shipped, other loas, invoices, purchase orders, checks, receipts, bills of lading, weight receipts, toll receipts, loading tickets, receiving tickets, shipping orders, manifests, inventories, letters and other correspondence, offers, contracts, agreements, bids, proposals, licenses, permits, reports to government agencies, ledgers, accounts receivable, accounts payable, account statements, financial statements, monthly reports, other reports, minutes of meetings, sales estimates, sales reports, source and use analyses, memoranda, handwritten or other notes, calendar or diary entries, agendss, bulletins, graphs, charts, maps, photographs, drawings, surveys, data, sampling results, analytical results, descriptions of materials, load schedules, price lists, sinnmaries, telegrams, teletypes, computer printouts, magnetic tapes, discs, microfilm, and microfiche. PURSUANT TO THE AUTHORITY OF SECTIONS 16 AND 17 OF THE TOXIC SUBSTANCES CONTROL ACT, FAILURE TO COMPLY WITH THIS SUBPOENA MAY RESULT IN THE INITIATION OF COURT PROCEEDINGS IN A UNITED STATES DISTRICT COURT AGAINST YOU TO COMPEL COMPLIANCE WITH THE SUBPOENA ISSUED at Washington, D.C., this ____ day of __________, 1988. Hon. J. F. Greene Administrative Law Judge United States & viron - ta1 Protection Pqency 401 M Street, S.W. (A—hO) Washington, D.C. 20460 ------- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY In the Matter of : S S SUN REPINING AND : MARKETING COMPANY, : Respondent S STATE OF PENNSYLVANIA • • _. Docket No. TSCA-87-N-07 COUNTY OF PHILADELPHIA S S AUBREY H. KIRBY, JR., being duly sworn law, deposes and says as follows: acccording to 1. From January 1, 1982 to December 1, 1986, I was the Manufacturing Coordinator, Oil Recovery Chemicals and Services, Applied Research & Development for Sun Refining and Marketing Company; 2. During the time period referred to in the previous paragraph, I coordinated the manufacture of Sun Tech IV-1035 Sulfonate, whose chemical designation is poly alkyl benrenesulfonate which is benrene sulfonic acid, methyl, mono C 10—20, alkyl derivatives, sodium salts; 3. Sun Refining and Marketing Company (Respondent) filed a Consolidated Premanufacture Notice (P)O1) with the Administrator of the Environmental Protection Agency (EPA) for poly alkyl benzenesulfonat. which is benezene sulfonic acid, methyl, mono C 10-20, a]kyl derivatives, sodium salts (chemical “B”) on December 2, 1982; 4. Th. number for the notice referr.d to in the previous paragraph was P)W 306; 5. The end of the P O1 review period was April 18, 1983; 6. A Notice of Commencement to Manufacture was sent to EPA on July 22, 1983 as reported in 48 P.R. No. 191, page 44897; ------- (2) 7. Respondent followed all the required statutory provisions with regard to the production of Chemical “B”; 8. In October, 1983, Respondent contracted with Pilot Chemical Company to produce chemical “B”; 9. During th. production of Chemical “B” at the Pilot Chemical Company plant, Respondent had no control of the, total amount of Chemical “B” produced or the basic technology for the plant process utilized to produce Chemical “B”; 10. After the production referred to in the previous paragraph, Chemical “B” was delivered to Respondent by Pilot Chemical Company. 11. Respondent has never contracted with Pilot Chemical Company to produce benezenesulfonic acid, methyl -, mono - C 10-20— alkyl derivatives (Chemical “A”); 12. Respondent has never accepted delivery of Chemical “A” from Pilot Chemicals Company. A rey M Kirby, Jr. - SWORN TO AND SUBSCRIBED BEFORE ME THIS 10th DAY OF JULY, 1987. L (.TY Ct44 Notary Public LS V. !;r’ 1 cv cLa I JhI dsI rIis. Ph: ,L:3hlz Cc• . , ty. M Mp Cw— $S’3t. .1 i :.’.I . . t ?S ------- Date of Service: ________________________________________________ Time of Service: ________________________________________________ Place of Service: ______________________________________________ 3. t effected that service of the said subpoena in the manner checked below: _____ By handing a true copy into the hands of the person named above and leaving the said copy with the said person. _____ 3y substituted service, that is, by delivering a true copy of the sat: subpoena into the hands of an individual of suitable age and discre- ho s at the residence and hane of the person named in paragraph 2 above and is believed by me to reside therein, and leaving a true co y of the said subpoena with the said individual. _____ By (registered mail] (certified mail return receipt requested] addressec to the person and address stated in paragraph 2 above, a true copy of the receipt for the said mailed subpoena being attached hereto. B ORE T} UNITW S1’AT VI N tAL P TEC ICN icy EPA R IC 10, 1200 STXfl! AVE IUE Seattle, WashIngton, (206) 442-1275 IN THE HA1’I’ OF: 4O.______________ AFFIDAVIT OF SERVICE OF SUBPO ZA UNITE SIAItS OF A €RICA) StAlE OF ) $3. C JWI? OF ) The Affiant undersigned, first being duly s rn, upon oath, deposes and says: 1 • Attached hereto is a true copy of a subpoena issued by the United States Fxivirormiental Protection Agency (EPA). 2. 1 made service of the said subpoena upon the following naned person on the date stated at the place stated: Person Served: I 2 3 4 5 6 7 B 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Dated: 25 26 27 28 Form 080 .103 13.0.78 OW AFFL (r SUBSCRIBE AND S RN before rue, the undersigned flotary Public, this of ________________, 198_. 1OtARY PUBLIC in and for tre 5c e of , residing at Page ti ------- BEFORE THE UNITED STATES ENV!ROI’1IENTAL PROTECTION AGENCY EPA REGION 10, 1200 SIXTH AVENUE Seattle, Washington, (206) 442-1275 IN THE HATTER OF: NO 1084-06-I1-]04Ew 60 to 65 Acres of Land in Kitsap County, Washington Containing OATH OF SUBPOENAED WITNESS AND Ron’s Wrecking Yard CLAIM FOR FEES AND MILEAGE ____________________________________________ BY__________________________________ UNITED STATES OF AMERICA) STATE OF Washington ) ss. COUNTY OF king ) I, the undersigned afflant, first being duly sworn, upon oath, state that I will respond truthfully and completely to all questions and inquiries lawfully put to me In these proceedings. (Si gnature) UBSCRIBED AND SWORN TO BEFORE ME this ______ day of ______________, 198. NOTARY PUBLIC in and for the State of ___________________ residing at______________ CLAIM FOR FEES AND MILEAGE: Attendance fees (@ S30.OO per day) Coiiinon Carrier Trave’ Actual Privately Owned Vehicle Actual Round—trIp Miles Travelled xSO.16S To 1 1 Cha r ge s Actual ly Pal do e_ _ a a a_a a a a a e a a aaaaa*aa a $ Subsistence (For Overnight Stay) Actually Incurred—————————--—————-S_ TOTAL: S Claim is hereby made for the total amount above pursuant to ‘5 U.S.C § 2610(c) and 28 U.S.C. § 1821. 4te:________________________________ ____________ (Si ynatur.) Mailing Address:______________________________________ WITNESS OATH AND CLAIM FOR FEES AND MILEAGE Page 16 ------- U.S. ENVIRONMENTAL PROTECTION AGENCY REGION X 1200 SIXTH AVENUI UATTLE, WASHINGTON 98101 pq it UP%! TO AtTN OPt Office of Regional Co msel, MIS 613 10 This letter advises you that the si rn interview of yourself currently being conducted by this Agency has not been canpieted, and you are required to return to this office for cauplec ton of that interview at the followiiig time on the foilo ng date: - DATE:______ DAY OF WEEK:____________________ We will make sincere efforts to complete the interview on that date, and we regret that our duties require that we inconvenience you further in thifl matter. Your indulgence and patience with our efforts uld be apprecia- ted. If you have any questions concerning this macter, please contact me, ______________________________ at 442—1275. Sincerely, Assistant Regional Co se1. Page T.7 ------- § 1001. ‘Wbov.r, in any matter within the jurisdiction of any department or agency of the United St.ate.i knowingly and willfully falsifies. con- ceala or coven up by any trick, scheme, or device a material fact, or makes any false, fictitious or fraudulent statements or representa. tions. or makes or uses any fals. writing or document knowing the same to contain any false, fictitious or fraudulent statement or entry. shall be fined not more than $10,000 or imprisoned not more than five years. or both. June 25. 1949. c. 643. 62 Stat. 749. Page 18 ------- 0F I IAL ANSW SU8PO LA DUCFS TF f BY M iIL O RES D : You havi been served with an EPA a iniscratlve subpoena duces tecun issued pursuant to the Toxic Substances Control. ACt (TSCA), 15 U.S.C. S 26 i and foLlowing sections. That subpoena requires that an individual personally attend a meeting at the time and place listed in the subpoena and then and there give testimony sider oath and also produce the records indicated in the subpoena. EPA hereby offers to you the alternative of responding to the subject subpoena by mail rather than attending in person and producing records and giving test i- mony. You uld be spared personal inconvenience by electing to respond to the subpoena by mail. Ho ver, you must follow carefully the following instruictions if you elect to respond to the subpoena by mail: 1 • You must telephone the following person pLw tly and state specificalLy that you thereby elect to respond to the subpoena by mail rather than in per- son. You must follow up on that call by sending a letter to the sene ef ect. _________________________________ Telep uie:_____________ Address: 2. You must make xerox or photocopies of each record which is in your pos- session or othetwise available to you, which you believe canes Within the des- cripcion set forth in the atcathnent to the subpoena. You must take care to include all records which the attact ent reasonably describes because you could later be subpoenaed again. 3. You must then package up those records and mail then or otherwise have then delivered ( together with an affidavit ) to the person named in paragraph 1 above at the address stated there. 4, The affidavit which must acc noany the shipped records is attached to these Instructions and must be signed and s rn to before a Notary Public. Please take care to read the affidavit carefully and he sure chat you u der- stand it b.for. you sign and s ar to it. 5. The affidavit and all the records must be in the hands of the person named thparagraph 1 above by the time specified In the subpoena. If it is absolutely necessary to request an extension of time, call the person named in paragraph 1 above to see whether an extension can be granted, and, If so, what the replacenent return date will be. 6. If you claim that sane portion of, or all. of, any record covered by the said subpoena is privileged, this obtion to respOnd by mail, is x avaiLabl.e to you, and you must appear in person at the time and place stated. OFFI OF R I NAL WJNS Page 1.t ------- DRE ThE LJNLI ST IE5 VL th 1IAL F TEC L 4 ICf EPA R I0N 10 AFFE AVIT RE P(14DI BY MAIL TO SUBP0E1 A DUCES TECUM _ .ATEOF ____________) ) as. COUNTI OF ________________) I, the n dersi ed a.ffianc, first being duly s rn, upon oath, depose and say: 1. Attached hereto are pages of photocopies of doc .inents or records. The attached pages are true and correct copies of records which I presently have in my custody and/or control as an owner and/or np1oyee of: _________________________________ the address of which is _______________ . 2. 1 i one of the custodians of the records of which the attached pages are true and correct copies. Those records have been subpoenaed by EPA arid are ethg produced along with this affidavit in response to that subpoena. 3. The records (of which the attached pages are true copies) here invol.ved te and/or are received and/or kept in the usual course of the regularly con- :ced business and activity of the entity listed in paragraph 1 above. The maid records are relied upon by me and others for the purpose of conducting every day affairs. The said records are usually prepared or re received at near the time the events to which they relate, upon the basis of knowledge f such events either by the person preparing the record, or knowledge of the ?erson cran nitting the infonnatton so that such record could be prepared. I have made a diligent search arid inquiry for all records which are reasonably described in the subpoena to which this affidavit responds. I have not foixid or Located, and I have not been cold about, and I have no knowledge of, any records caning within the descriptions set forth in the said subpoena which have riot been copied and subuitted along with this affidavit. 5. 1 acknowledge that this affidavit is su±itted to the United States in connection with a n atter within the jurisdiction of A and that any ma. cerial false statenent of fact herein may be a crime i.rider 18 U.S.C. S 1001. _________________________ SI I E D:______________________________ ‘riPED NAZ’IE:______________ OFFICE OR TITLE:_______________________ RN AND SUBSCRIBED TO before me, the t dersigned Notary Public on this _______ yof . 198 (SEAL) NOTARY PUBLIC in and for the State of ________________ residing at age 20 ------- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY In the Matter of : S S SUN REFINING AND : MARKETING COMPANY, : Respondent U : STATE OF PENNSYLVANIA S U S • . Docket No. TSCA-87-H-07 COUNTY OF PHILADELPHIA S . AUBREY H. KIRBY, JR., being duly sworn law, deposes and says as follows: acccording to 1. From January 1, 1982 to December 1, 1986, I was the Manufacturing Coordinator, Oil Recovery Chemicals and Services, Applied Research & Development for Sun Refining and Marketing Company; 2. During the time period referred to in the previous paragraph, I coordinated the manufacture of Sun Tech IV-1035 Sulfonate, whose chemical designation is poly alkyl benzenesulfonate which is benzene sulfonic acid, methyl, mono C 10—20, alkyl derivatives, sodium salts; 3. Sun Refining and Marketing Company (Respondent) filed a Consolidated Premanufacture Notice (P 1 W) with the Administrator of the Environmental Protection Agency (EPA) for poly alkyl benzenesulfonate which is benezene sulfonic acid, methyl, mono C 10—20, alkyl derivatives, sodium salts (chemical “3) on December 2, 1982; 5. The end of the P1*1 review period was April 18, 1983; 6. A Notice of Commencement to Manufacture was sent to EPA on July 22, 1983 as reported in 48 F.R. No. 191, page 44897: 4. The number for the previous paragraph was P101 notice referred to in the 306: 000003 ------- (2) 7. Respondent followed all the required statutory provisions with regard to the production of Chemical “B”; 8. In October, 1983, Respondent contracted with Pilot Chemical Company to produce Chemical “B”; 9.- During the production of Chemical “B” at the Pilot Chemical Company plant, Respondent had no control of the, total amount of Chemical “B” produced or the basic i.chnology for the plant process utilized to produce Ch.mical “B”; 10. After the production referred to in the previous paragraph, Chemical “B” was delivered to Respondent by Pilot Chemical Company. 11. Respondent has never contracted with Pilot Chemical Company to produce ben.zen.sulfonic acid, methyl -, mono - C 10—20— alkyl derivatives (Chemical “A”): 12. Respondent has never accepted delivery of Chemical “A” from Pilot Chemicals Company. . A rey I4 Kirby, r. SWORN TO AND SUBSCRIBED BEFORE ME THIS 10th DAY OF JULY, 1987. 4a i ( C. Notary Public FVJI L v. c . IJLI DJ I%ds1:rns. u I ,ii Ce.iwp. M M C ari— ssi i !‘r s .‘.i :. . tc’ ------- R ------- IN THE UNITED s’rA’rES DISTRICT COURT FOR THE NORTHERN DISTRICT OF FLORIDA IN THE HA1 ER OF, Basso Chemical Inc. WARRANT FOR INSPECTION UliDIRLI’H1 TOXIC SUBSTANCEE CON!MOL ACT Tos Donald Stack, Carlto HaLley, and Jill Perry, Enforcement Off icers, U. S. Environmental Protection Ag.ncy, Region IV; Application having b..n.mad• and probabl• cause shown, by the U. 8. Attorney for the Northern District of Florida, for a warrant to enter, inspect and sample ths establishment described ass Basso Chemical Inc. 3211 Pow.rg Avenu• Jacksonvill•, FL 32207 Pursuant to the Toxic Subutance Control Act, 13 u.s.c. 2610, and the decisions of Ut• Supreme Court in Xmrshal.1 vrl pi’i. _ Inc. . 98 S.Ct. 1816, you ar. authorized to “ mediate1j enter thi above-described premises upon presentation of this warrant at reasonabi. times during busin.ss hours to inspect all process.., controls, and facilities; to inspect and copy all records, f ties, and papers regarding manufacture, processing, distribution, sale, packaging, transportation, storag. and/or disposal of chemical substances associated with the premises; and to inspect and sample any and/or all chemical substances or mixtures within the premises or in/on any conveyance utilized in th, transport of chemical substances or mixtures at or near the premises to determine wh.th•r the r.quirem.nts of the TO*ic Substances Control Act applicable to the facility and/or th. chemical substances or mixtures hays been complied with. The duratioa of the inspection shall be of such a length as to enable the abov...naaed enforcement officers to satisfactorily coaplet the inspection. DATED. _ - JUDO! Inspection of the establishment described in this warrant was completed on __________________ ------- unless th. natur, and extent of such data are deacrli with reasonabi. specificity in the written notice required by subsection (a) for such inspection... 3; ..so Chemical Inc. is engaged in th. business of manufacturing, processing, sailing, distributing, and/or disposing of chemical substances and mixtures. 4. This warrant is required in order to obtain information necessary to ____________ 5. The inspection viii. begin as soon as practicable aftar issuance of this warrant and viii be conducted with reasonable promptness but continuously and without interruption until conpl.ted. 6. The enforcement off Lc.r may be accompanied by one or more other employees of the United States Invironmental Protection Agency. 7. The .nfordement officer requests imesdiate entry to Basso Chemical Inc. tO perform the inspectiom. 3. A return will be made to the court at the compl.tion of th. inspection. 9. The authority for ths issuanc. of th. Lnapectio warrant is Section i i of the Act, 15 U.S.C. 26lO, araI1ai.1.jrA... Barlow. Inc. , 90 I.Ct. 1816, _ — — — . C.’i. , • Donald 8tac Assistant Regional Counsel US IPA, Region XV ------- sale, handling, packaging, transportation, storage and/or disposal of polychiorinated biphenyls(PCB 5) in any form during the period of April 10, 1970 through the pres.ntj and inspection and sainp]ing of all PCI chemical substances, PCI mixtures, PCI articles, and PCI container, located at the premises or in/on Conveyances ut5 1ized La the transport of chemical substances or mixtures at or near th. premises. 2. This warrant is sought under Section 11 of the Act, 15 U.S.C. 2610, which provides in pertinent parts SIC. 11 INSPICTIOIII AND $UBPOENM. (a) In General..4or purposes of administering this Act, the Administrator, and any duly designated representative of the Administrator, may inspect any establishment, facility, or other pr.ts.s in vhjç) chemical substances or mixtures are aanufactur.d, processed, stored, or held before or after th.ir distribution in co erce. Such an inspection say only be mad• upon th. presentation of appropriate credentials and of a written notice to the own.r, operator, or agent in charge of th. premises or conveyance to be inspected. & separate notice shall be given for each such insp.ctionb ut a notice shall not b required for each entry made during the period covered by the inspection. Saab such inspection shall be co’, a.nced and completed with reasonable promptness and shall be Conducted at reasonable times, within reasonabl• limits, and in a reasonable manner. (b) Scope.-..(l) Ixcept as provided in paragraph (2), an inspection conducted under subsection (a) shall extend to all thinS, within the premises or conveyance inspected (including records, tiles, papers, processes, controls, arid facilities) bearing on whether the requirement. of this Act applicable to the chsa.tcal substances or mixtures within such premises or conveyance have been complied with. (2) We inspection under subsection (a) shall extend to-. (A) financial data, (I) sales data (other than shipment data), (C) pricing data, (D) p.rsonn.l data, or (3) research data (other than date required by this Act or under a rule promulgated ther*- under), ------- IN TIlE UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF FLORIDA IN TIlE NATTER Oi l Baiso Chemical Inc. - APP IDAVIT IN SUPPORT OP APPLICATION P0* WARRAIf STATS OP FLORIDA COUNTY OP DUVAL Donald Stack being duly sworn upon his oath, according to law, deposes and sayss 1. I am a duly authoris.d snforcs.ant officer of Region IV, United Stats. Environmental, Protection Agency. I hereby apply for a warrant pursuant to Section 11 of th. toxic Substance. Control Act (the ‘Act), IS U.S.C. 2610, fog the inspection, copying, and sampling of th. items named below in Uts possession, custody, or control of Basso Chemical Inc. on the premises or in/on conveyances utilized in th. transport of chemical substances or mixtures at or near the premises located at 3211 Powers Avenue, Jacksonville, Florid.. To inspect all proc•ss.s, control., and faeLlitL.s to inspect and copy all records, files, and papers; and to inspect and sampis any or ill chemical substinces OX mixtures within the pami see or in/on convs es utilized La the transport of chemical substances or mixtures at or near the premises bearing on whether tb. requirement., of the Toxic Substances Control Act pplicabl. to the chemical substances and mixtures hav bean complied with. The above data should incluad inspection of all processes, controls, and facilities; inspection and copying 00 all record., files, and paper, bearing on or relating to the ------- -2. This warrant is sought und.r Section 11 of the Toxic Substances Control Act, 15 U.S.C. • 2610 which provides, in pertinent parts (a) Zn General. For purposes of adminiat.rin this Act, the Administrator, and any duly designate representative of the Administrator, may inspect any establishment, facility, or oth.r premises in which chemical substances or mixtures ar manufactured, processed, stored, or held before or after their distribution in coemrce. Such an inspection may only be made upon th. presentation of appropriate credentials and of a written notici to the owner, operator, or agent Lu charg. of the premises or conveyance to be inspected. A separate notice sh 1l be given for each s ach inspection, but a notice shall not be requir.d for each entry mad. during he period covered by the inspection. Sach such inspection shall be comeenced and completed with reasonable promptness and shall be conducted at reasonable times, within reasonable limits, and in a reasonable manner, (b) Scope.-’u(l) Sxc.pt as provided in paragraph (2), an inspection Conducted under subsection (a) shall oxt.rtd to all things within the premise, or conveyance inspected (including records, files, papers, processes, controls, and facilities) bearing on whether the requirements of this Act applicabl, to the chemical substances or mixtures within such premise. or conveyanc• have been complied with. (2) Ne inspection under Subsection (a) shall extend to—.. (A) financial data (S) sales data (other than shipment data), (C) pricing data (0) personnel data, or (I) research data (other than data required by this Act or under a rule promulgated thereunder), rnlsss the nature and extent of such data are described with resonable specificity in the written notice required by subsection (a) for such inspection.... ------- —3— Basso Chemical Inc. is engaged in the business of manufacturing, proc.ssing, selling, distributing, storing and/or disposing of chemical substances and mixtures, as these terms ar, d.fined in Section 3 of the Act. This warrant is required in order to obtain information necessary io SPA to adequately discharg• its responsibilities under the Toxic Substances Control Act, Section 313, 15 u.s.c. ________ ________ and to ensure that —. Th, inspection will be conducted at a reasonable tim. by duly authoris.d enforcement officers of the U.S. Invironnental Protection Agency, legion IV, as soon as practicable after issuvtc. of this warrant and viii be of such duration as to allow the inspectors to satisfactorily complete the inspection. WHERSIORI, SPA r.qu.sts that a warrant to enter, inspect, and sample, and copying of records from the abov-refsr•nced property be Lssu.4 for the purposes stated herein. 0000 ------- —4 Zn support of this application, the Regional Administrator respectfully submits th. accompanying affidavit and propos.d warrant. Respectfully Submitted, Unitd States Attorney By, - - Assistant U.S. Attorney Northern District of Florida Of Counsels !dwin Schwarts Assistant Regional Counsel U.S. liwironmental Protection Agency 345 Couxtiand Stre.t, LW. Atlanta, Georgia 30365 ------- IN PH! UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OP FLORIDA IN THE XM’TER Oh Basso Chemical Inc., Application for Wartant 3211 Powers Avenu• ) to Enter, Inspect and Sup. Jacksonville, FL 32207 ) Pursuant to Section 11, of the Toxic Substances Contri Act, 15 U.S.C. Section 2611 ) CO1 5 NOW the ‘4 n3.strator of th. United Stats. Environemntal Protection Agency (SPA), by and through U • S. Attorney, and appli.. for a warrant pursuant to and accórdancs with Section U of the Toxic Substances Control Act, 15 U.S.C. 52610, for the purpos. of .itabling duly authorised EPA •nforcaemnt personnel to enter upon the premises of and to conduct in a (nistrative inspection of Basso Chemical Inc., of Jacksonville, Florida as follows, To inspect all proc.ss.s. op.rationl, and facilities; to Lnsp.ct and soise and/or copy all records, files and papers regarding manufacture, process Lag, distribution, sale, packaging, transportation, storage and/or disposal of chemical substances associated with the premises; and to inspect and sample .fl7 or all chasieal •ubataces or mixtures within the premises or in/on conv.yanc.s used to transport such chemical substances or mixtures at or near the premises to determins whether th• r.quiza.snts of the To*ie Substancss Control Act applicabl, to the facility and/ot the cPtical substances and mixtur.s hays been complied with. 000011 ------- a ( swear that this inventory is a true end detailed account of the roperty taken by me on this warrant. • ,• •/• — I, 4 II / ‘ - ‘ I,.—,. Jonftt1 án 0. Al n ’ EP Enforcement officer Subscribed, sworn before me, and returned to me on this date 7/27/i’j • strat. Date £0d 9B&29 9 0.1. iS3d 8 X0J. III NOI d3 WO St:ST 68GT/G /8 ------- turn of gproh tajrant Docket We. S9—14$M 1. Dat. of Warrant: une 29, 1989 2. Dates Warrant executed: Warrant was executed on July 5, 6, i; 12, 13, and 14, 1989. 3. A certified copy of the warrant was given to Mr. Francis Rattay and Mr. Spencer Nunley, both of Mobay Corporation, on July 5, 1989. 4 • An inventory of documents taken and copied was mad• in the presence of Mr. Francis Rattay and Mr. Robrt Sankston, both of Moeay Corporation. Mr. Rattay also signed TSCA Receipt for Samples and Documents forms for the documents taken and copied. 5. A total of approximately 56$ documents were either taken or copied on site. These documents measure approximately 18.5” x a.S x 11.. 6. The original documents taken from the site ar. mainly .Moba product information publications which are generally availabl, to the public. The documents taken are as follows: - Bonding Agent Additive ICA—9 12$ Product Information - L.vatit/Lewa.orb: Ion Exchange Resins and Catalysts Product Information (3-ring binder) - Nydur A, AXV, and B V Product Information - Roekydal 500* Product Inførmatioit - Vulkacit RA-9124 Product Information - craain Pigments: tionionic and Anionic Pigment. for Textile Printing - Lsvatit/L.va.orb: Ion Exchange Resins for Industry and the Homa - Kicro]u: Dyu for Plastics - Rev Materials for High Performance coatings: Product Index - The .miatry of Polyurethane Coatings: A General Reference Manual Other c” inta - Bayer USA: Annual Report 198$ - Computer printout of liquidated and nonliquidated customs entries (SALES3OIP REPORT) - Mobay Corporation Organization Plan, February 3.988 - Mobay Facts booklet 000009i e d 9982Z8 9 01 lSBd I X0i. I !! NO I DB d3 WQeU Pt : St 68GTi6 /8O ------- UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OP PENNSYLVANIA IN THE MA ZR OF! ) ) Environmental Protection Agency ) Docket No. 14s. I .4 SM Administrative Warrant ) ) WARRANT AUTHORIZING ENTRY, INSPECTION, COLLECTION, AND COPYING OP DOCUMENTS PURSUANT ‘tO the Toxic Substances Control Act (TSCA) • 42 U.S.C. fi 2601—2654; TO: Hr. K. K. Wu md Mr. Jonathan Allen, United States Environmental Protection Aqency (“EPk ), Region III, and any authorized attorney or representative of said Agency or any other agency of the Federal Government; Application for entry, inspection, collection and copying of documents having been made and applicant having deaonstrat d through application and affidavit of Mr. Jonathan Allen, EPA Region III , that the issuanc, of this warrant ii constitutional, based upon a right of entry authorized by statute, and is based upon the reasonable belief that violations of TSC& may be discovered, and other sufficient cause for th• issuance of this warrant having been demonstrated by such application and supporting affidavit and this officer therefore having been satisfied that this warrant is properly issued; WHEREFORE, you are hearby authorized to enter the premises of Mobay corporation, Corporate Headquarters, l4obay Road, Pittsburgh, Pennsylvania, at reasonable hours of the day, commencing July 5, 1989 and continuing for fourteen days or until further action by this court, for the purpose of inspection, colliction and copying of documents, pursuant to TSCA. This authority shall extend to all documents regarding various substances which wer, the .ubj sCt of certain prs-panufaoturs notices (‘P C1e )and Notice. of Commencement (NNOC5 ) • and products which may have contained thee . substances, including, but not limited to, dyes, pigment., coatings, ion- exchange resin, and coagul ants. The documents to be inspected, collected and copied include: 1. Documents relating to Mobay Corporation’s r.cordkeepinq policies. 2. Import Certifications under Section 13 of TSCA and documents relating to the preparation of such certificates; ------- 2 3’ U.S • Customs Service Consumption Entry Forms and Entry S ries, and any related forms. 4. Import Invoices and Purcahse orders; 5. Intercompany order record ., transfer records and payment record.; 6. Intracompany order records, transfer records and payment records; 7. Sa].s maoranda, orders, bills and invoice.; 8. Shipping records; 9. Customer lists and accounts; 10. Product literature and catalogs; 11. Material Data Saf.ty Sheets; 12. Formulation records; 13. Product specification records; 34. Chemical composition records; 15. Correspodemce, notes and meat,randa regard ing chemical composition of products. 16. Quality assurance and quality control records; 27. Production and batch records; 18. Inventory logs or records; 19. Year-end import, production and inventory s” ri.s; 20 • Records regarding product rames , generic names and company product code .; 21. DocuIents rslating to th process of preparing the P O(a an4 iiocs, and the decision to initiat, the PtOI process. 22. Copies of the P Q1s and NOC5; 23. Copies of EPA ’s Acknowledgement of Receipt of the PJO s; 24. Records and memoranda relating to Mobay’. submissions to EPA regarding the 3978 Initial T$C Inventory under Section 8 (b) of TSCA and the 1986 inventory update under TSCA S.ction 8(a). 000007 988l28 g 01 .LS3d X C I I!! NCIO d3 W0 9t:St 686T,6 ,8Ø ------- 3 25. ascords regardinq potential adverse health or environmental effects, maintained pursuant to Section 8 of TSCA. 26. All other documents. reasonably related to the investigation of the P W5 and NOC5 in question. The duration of the entry, inspection, collection and copying of documents shall be for a reasonable time to enable you to complete those activities. A prompt return of this warrant showing completion of the entry, inspection collection and copying of these documents contemplated hereby shall b made within 11’ — days of this date, together with an inventory of any property removed from the premises. Dated this ______ day of g.zi4.......L, 1989. L I 4& - uniter sta MagistrTts t )torbp cutup iM pecaltyoE Ps3r )ur7 1 tat t Ilttb1flia atru p ______ XAL Dats ______ 90d 988428 9 OJ. IS3d XO.L III NOL d3 WQe 4.t:St 686t/6 ’8O ------- Jonathan Allan - chc ical Enginasr and Enfoxcoa.nt Officer Suicribed and sworn b•fore me this . day of —g 1989. 7 I.s / )ah... I Unitd States Kagistrats 000005 ------- Jonathan u.n, being duly sworn, deposes and says: • am a Chemical Engineer and Enforcement Of ficer with the United States Environmental Protection Agency (NEPAN). wy duties includ• the investigation of potential violations of the federal laws relating to the manufacture of chemical substances and the preparation of enforcement cases involving those laws. 2. I an currently involved in an investigation involving possible violations of the Toxic Substances Control Act, 15 U.S.C. § 2601-2654 (TSC ) by the Mobay Corporation, whose corporate headquarters i. located in Pittsburgh, Pennsylvania. Mobay is a wholly-owned subsidiary of layer AG, a West German firm. The investigation involves certain chemical substances which Mob’ay imports into the United States. 3 • Under Section 5 of TSCA a notice must be shaittad to EPA 1 at least 90 days before any new chemical substance is manufactured in the United States. Pursuant to Section 3 of TSCA manufacture 1 includes importation. This notice, known as a “pre—aenufacture notice or “PNN,’ must include certain enumerated information. In addition, pursuant to section 5 another notice, known as a Nnotic. of commenc,v !LtU or NOC, must be filed withI i. 30 days after a new chemical substance is first manufactured or imported. 4. Through discussions with other EPA officials I have learned that betwes Juns and December, 1988, EPA received a group of approximately 40 PIWs from Kobay Corporation. EPA has subsequently received WOCs for several substances referred to in these P1 111 5. As discussed below, EPA now has reason to believe that some of the 80d 988 28 8 Oj .LS3d XO1 II! NO!O3 bd3 WOd 8t:St 686t’6 ’8O ------- 2 chemical substances which were included in these P!QI 5 and NOCs may have been imported into the United States prior to Mobay’ s submission of iws for them, in violation of TSCA. After consultation with reliable sources of information, I believe that certain substances which vera the subject of the PIWs and NO in question were in fact contained in products marketed by Mobay in the United States prior to 1988. 5. in 1978, when Mobay was required to submit to EPA information regarding .11 chemical substances produced by it, Mobay represented to EPA that a certain product lin, was essentially the sane as products made by its competitors. A reliable source now informs me that prior to 1988 Mobay told at least one potential! customer that the product line was in fact mad. in a different manner than compititors’ products, resulting in a different and purportedly superior product. In addition, according to the same source, this entir. group of products sold by Kobay prior to 1988 was unavailabl* to purchasers from early 1988 until after the submission of thO qreup of PlQls in late 1988, after which Mobay again made the product lin, available. Based upon my experience as an investigator and enforcement officer, I believe that there may a similar situation with other Mobay products. 6 • Based upon my experience as an investigator and .nfercment officer, I believe that ther. are substantial questions regarding all of the P W* submitted by Mobay between June and December, 1988, and that a thorough investigation of documents in Mobay’s 0C0003 988l28 8 01. 1S d ‘<01 III N0TLJ F 4 L ifl 4-4 t ct t’ ?’QI ------- 3 possession rsgarding these PIC s and the substances to which they referred is reasonably likely to reveal violations of TSC . 7. Through discuesion with my colleagues at EPA I have become familiar with the Mobay Corporation corporat. headquarters, located on Mobay Road in Pittsburgh, Pennsylvania. This facility contains records regarding all aspects of Mobay’. operations, and im ths facility at which import orders and other import arrangements are accomplished. I bsliev. that many of the records which are necessary to investigate the issues discussed abov. will be found at said facility. 8. Based upon prior experience of EPA inspectors at said facility, I believe that EPA is likely to encounter substantial resistance in conducting an inspection of the magnitud. necessary to investigate the issues discussed above. I believe that it is likely that EPA inspectors will be refused entry to the facility in the absenc. of an administrativ, search warrant. 9 • Based upon my .xperienc. as an investigator and enforcement officer, there is substantial reason for concern that the documents needed by EPA may be destroyed if they are not inspected, collected and copied at the earliest possible date. If EPA presents itself for inapsation vithout a warrant and is refused entry, there is reason for concern that moms of th. documents sought may be destroyed in the tins it takes to cons before the court and obtain a warrant. 01d 9B9428 8 01 iS3d X0i III N0I0 W0 6t:St 6S6t’6 ’8 ------- EflIITED STATES DISTRICT COURT FOR TEE WESTERN DISTRICT OF PENNSYLVANIA IN THE MAI’rER OF: ) Environnental Protection Agency ) Docket No. hess. ff_j if, c. Adainistrative Warrant ) ) APILX CATION FOR AUMINISTRATIVE SEAR WARRANT NOW COEES the United States of Aaarica, on behalf of the United States Environmental Protection Agency (“EPA), by and through the United States Attorney for the Western District of Pennsylvania, and applies for an administrative warrant to enter, inspect, collect end copy documents at th. Nobay Corporation Corporate Headquarters, Mobay Road, Pittsburgh, Pennsylvania. This entry is for the purpose of investigation pursuant to the Toxic Substances Control Act, 15 U.S.C. 2601—2654 (UTSCAN). The document inspection, collection and copying is authorized under TSCA Sections 8 and 11, 15 U.S.C. §1 2907, 2610. Approximately two weeks will be required to complete the process of inspection, collection and copying of documents. Sections 8 and 11 of TSCA, 15 U.S.C. 5 2607, 2610 authoriz EPA to conduct inspections which extend to records, files, paper’s, processes, controls and facilities bearing on whether the requir m.nta of TSCA have been complied with. Section 11 requires that notice be given to the owner, operator or agent in charge of the premises, but does not provide that such notice be given at any specific time interval prior to the inspectidgI. Section 11 also requires that certain information sought during the inspection be described with reraonab].e specificity in the written notice, including in relevant part financial data, sales data (other than shipment data), and research data. In support of this application the United States submits an affidavit and a proposed warrant. Respectfully submitted, Cha ies D. Sheehy Acting United States Attorney __________ by_____________________________ Date Amy Hay Assistant United States Attorney 00000 1 L d 988 Z8 9 C i .LS3d XCI III NCj 3 3 LT:St S86T,6 ,8e ------- UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF PENNSYLVANIA IN THE MATYER OF: ) Environmental Protection Agency ) Docket No. r - . -i*’fft Administrative Warrant ) ) A LZ TTON FOR ADMINISTRATIVE SEARCN WARRANT NOW COXES the United States of America, on behalf of the United States Environmental. Protection Agency (“EPA”), by and through the United States Attorney for the Western District of Pennsylvania, and applies for an administrative warrant to enter, inspect, collect and copy documents at the Mobay Corporation Corporate Headquarters, Mobay Road, Pittsburgh, Pennsylvania. This entry is for the purpos. of investigation pursuant to the Toxic Substances Control Act, 15 U.S.C. § 2601-2654 (“TSCA”). The document inspection, collection and copying is authorized under TSCA Sections 8 and 11, 15 U.S.C. § 2907, 2610. Approximately two weeks will, be required to complete the process of inspection, collection and copying of documents. Sections 8 and 11 of TSCA, 15 U.S.C. § 2607, 2610 authorize EPA to conduct inspections which extend to records, files, papers, processes, controls and facilities bearing on whether the requirements of TSCA have been complied vith. Section 11 requires that notice be given to the owner, operator or agent in charge of the premises, but does not provide that such notice be given at any specific time interval prior to the inspection. Section 11 also requires that certain information sought during the inspection be described with rc sonab1e specificity in the written notice, including in relevant part financial data, sales data (other than shipment data), and research data. In support of this application the United States submits an affidavit and a proposed warrant. Respectfully submitted, Charles D. Sheehy Acting United States Attorney __________ by______________________________ Date Amy Hay — Assistant United States Attorney L@ d 989428 9 0.1. .LS3d 2 XOJ. I I I NO I O3 d3 WO Lt St 686t,6 ,’8g ------- Jonathan Allen, being duly sworn, deposes and says: 1. I am a Chemical Engineer and Enforcement Officer with the United States Environmental Protection Agency (“EPA”). xy duties include the investigation of potential violations of the federal laws relating to the manufacture of chemical substances and the preparation of enforcement cases involving those laws. 2. I am currently involved in an investigation involving possible violations of the Toxic Substances Control Act, 15 U.S.C. § 2601-2654 (TSCA) by the Mobay Corporation, whose corporate headquarters is locat.d in Pittsburgh, Pennsylvania. !4obay is a wholly-owned subsidiary of Bayer AG, a West German firm. The investigation involves certain chemical substances which Mobay importa into the United States. 3. Under 8ection 5 of TSCA a notice must be submitted to EPA at least 90 days before any new chemical substance is manufactured in the United $tatss. Pursuant to Section 3 of TSCA “manufacture” includes importation. This notice, known as a “pre—manufacture notice” or “ io ,” must include certain enumerated information. In addition, pursuant to Section 5 another notice, known as a “notice of commencement ’ or “NOC,’ must be filed within 30 days after a new chemical substance is first manufactured or imported. 4. Through discussions with other EPA officials I have learned that between June and December, 1988, EPA received a group of approximately 40 P)OIs from Mobay Corporation. EPA has subsequently received NOCs for several substances referred to in these P1*s. As discussed below, EPA now has reason to believe that some of the 80d 988428 8 Di. lS9d 2 XCI. III N0ID3 d3 W0 d BT:ST 68St/G ,’8O ------- 2 chemical. substances which were included in these PMNs and NOCs may have been imported into the United States prior to Mobay’s submission of PO s for them, in violation of TSCA. After consultation with reliable sources of information, I believe that certain substances which were the subject of the PIWs and NOCs in question wan, in fact contained in products marketed by Mobay in the United States prior to 1988. 5. In 1978, when Mobay was required to submit to EPA information regarding all chemical substances produced by it, Mobay represented to EPA that a certain product line was essentially the same as products made by its competitors, A reliable source now informs me that prior to 1988 Mobay told at least one potential customer that the product line was in fact made in a different manner then competitors’ products, resulting in a different and purportedly superior product. In addition, according to the same source, m this entire group of products sold by Mobay prior to 1988 was unavailable to purchasers from early 1988 until after the submission of the group of PMNs in late 1988, after which Mobay again made the product Line available. Based upon my experience as an investigator and enforcement officer, I believe that there may a similar situation with other Mobay products. 6. Based upon my experience as an investigator and enforcement officer, I believe that there are substantial questions regarding all of the PlOls submitted by Mobay between June and December, 1988, and that a thorough investigation of documents in Mobay’s 60d 988 28 9 01 iS3d X01 III NOTtJ3?J I d t i0 i-i T:ct ------- 3 possession regarding these P Ws and the substances to which they referred is reasonably likely to reveal violations of TSCA. 7. Through discussions with my colleagues at EPA I have become familiar with the Mobay Corporation corporate headquarters, located on Mobay Road in Pittsburgh, Pennsylvania. This facility contains records regarding all aspects of Mobay’s operations, and is the facility at which import orders arid other import arrangements are accomplished. I believe that many of the records which are necessary to investigate the issues discussed abov. will be found at said facility. 8. Based upon prior experience of EPA inspectors at said facility, I believe that EPA is likely to encounter substantial resistance in conducting an inspection of the magnitude necessary to investigate th. issues discussed above. I belie”. that it is likely that EPA inspectors will b refused entry to the facility in the absenc. of an administrativ . search warrant. 9. Based upon my experience as an investigator and enforcement officer, there is substantial reason for concern that the documents needed by EPA may be destroyed if they are not inspected, collected and copied at the earliest possible data. If EPA presents itself for inspction without a warrant and is refused entry, there is reason for concern that some of the documents sought may b destroyed in the time it takes to con. before the court and obtain a warrant. 0Td 988 Z8E8 01 .LS3d 8 XO1 III N0I03 WO d 6t:St 686T/6 ,9@ ------- 4 Jonathan Allen Chemical Engineer and Enforcement Officer Suscrjbed and sworn before me thie ______ day of ___________, 1989. , i )a1 4 United States Magistrate ------- UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OP PENNSYLVANIA IN THE MATTER OF: ) ) Environmental Protection Agency ) Docket No. Mee. i t Administrative Warrant ) ) WARRANT AUTHORIZING ENTRY, INSPECTION, COLLECTION, AND COPYING OP DOCUMENTS PURSUANT TO the Toxic Substances Control Act (TSCA) • 42 U.S.C. H 2601—2654; TO: Mr. K. K. Wu and Mr. Jonathan Allen, United States Environmental protection Agency (“EPA”), Region III • and any authorized attorney or representative of said Agency or any other agency of the Federal Government; Application for entry, inspection, collection and copying of documents having been made and applicant having demonstrated through application and affidavit of Mr. Jonathan Allen, EPA Region III , that the issuance of this warrant is constitutional, based upon a right of entry authorized by statute, and is based upon the reasonabl. belief that violations of TSCA may be discovered, and other sufficient cause for the issuance of this warrant having been demonstrated by such application and supporting affidavit and this officer therefore having been satisfied that this warrant is properly issued; WHEREFORE, you are hearby authorized to enter the premises of Mobay Corporation, Corporate Headquarters, Mobay Road, Pittsburgh, Pennsylvania, at reasonable hours of the day, commencing July 5, 1989 and continuing for fourteen days or until further action by this court, for the purpose of inspection, collection and copying of documents, pursuant to TSCA. This authority shall extend to all documents regarding various substances which were the sub cct of certain pri—manufacture notices ( P Q1aN)and Notices of commencement (“NOCs”), and products which may have contained these substances, including, but not limited to, dyes, pigments, coatings, ion- exchange raina and coagulants. The documents to be inspected, collected and copied include: 1. Documents relating to Mobay Corporation’s zecordkeepinq policies. 2. Import Certifications under Section 13 of TSCA and documents relating to the preparation of such certificates; ------- 2 3. U.S. customs Service Consumption Entry Forms and Entry Summaries, and any related forms. 4. Import Invoices and Purcahse Orders; 5. Intercompany order records, transfer records and payment records; 6. Intracompany order records, transfer records and payment records; 7. Sales memoranda, orders, bills and invoices; 8. Shipping records; 9. customer lists and accounts; 10. Product literature and catalogs; 11. Material Data Safety Sheets; 12. Formulation records; 13 • Product specification records; 14. Chemical. composition records; 15. - Correspodence, notes and memoranda regarding chemical composition of products. 16. Quality assurance and quality control records; 17. Production and batch records; 18. Inventory logs or records; 19. Year-end import, production and inventory s ” ries; 20. Records regarding product names , generic names and company product codes; 21. Documents relating to the process of preparing the P)*ls and NOCs, and the decision to initiat, the P Q process. 22. Copies of the P O4s and NOCs: 23. copies of EPA’S Acknowledgement of Receipt of the P * s; 24. Records and memoranda relating to Mobay’ a submissions to EPA regarding the 1978 Initial TSCA Inventory under Section 8(b) of TSCA and the 1986 inventory update under TSCA Section 8(a). Sø d 988228 8 01 IS3d XC I I II N0I0 WO 91: SI 68Gt ’6 ,Be ------- 3 25. Records regarding potential adverse environmental effects, maintained pursuant of TSCA. health or to Section 8 related question. to the The duration of the entry, of documents shall be for a complete thos. activities. inspection, collection and copying reasonable time to enable you to A prompt return of this warrant showing completion of the entry, inspection collection and copying of these documents contemplated hereby shall be made within fir — days of this date, together with an inventory of any property removed from the premises. Dated this j 9 )Li ) daY of ____ 1989. I haroby cettlfy wtdi’ paMity OS D. rJury 1 that tk• vithin ia a ti’i&s and orrot ooy o tha o ’18 1 1m1 U ftli4. , sI L. Un t sta Mag strate 26. All other documents reasonably investigation of the PMNs and MOCs in 988228 9 01 .LS3d 8 XCI I II NC! D3 3 W0 : St 6G6t,6 ,eg ------- Return oLSearch Wa raa Docket No. 8914ax 1. Date of Warrant: Jun. 29, 1989 2. Dates Warrant executed: Warrant was executed on July 5, 6, 1 12, 13, and 14, 1989. 3. A certified copy of the warrant was given to Mr. Francis Rattay and Mr. Spencer Nunley, both of Mobay Corporation, on July 5, 1989. 4 An inventory of documents taken and copied was mad . in the presence of Mr. Francis Rattay and Mr. Robert Sankaton, both of Mo ay Corporation. Mr. Rattay also signed TSCA Receipt for samples and Documents forms for the documents taken and copied. 5. A total of approximately 568 documants were either taken or copied on site. These documents measure approximately l 8 . 5 n x 8.5” x 1]’. 6. The original documents taken from the site an, mainly Mobay product information publications which are generally available to the public. The documents taken are as follows: Prg uct In rmat ion - Bonding Agent Additive ICA—9128 Product Information - Lewatit/Levasorb: Ion Exchange Resins and Catalysts Product Information (3-ring binder) - Nydur A, AXV, and 5KV Product Information - Roskydal 500k Product Informatioit Vulkacit KA—9324 Product Information ? roduct References -‘ Acramin Pigments: Nonionic and Anionic Pigments for Textile Printing - L .vatit/Levasorb: Ion Exchange Resins for Industry and the Hone - Maczolax: Dyes for Plastics - Raw Materials for High Performance coatings: Product Index - The Chemistry of Polyurethane Coatings: A General Reference Manual Otb Documents - Bayer USA: Annual Report 1988 - Computer printout of liquidated and nonliquidated customs entries (SALE52OI. REPORT) - Mobay Corporation organization Plan, February 3.988 - Mobay Facts booklet ?O d 988L 8 8 OJ. iS3d I XOJ. 11! NOI J3 WO j P :ST S86 ’6 ’8O ------- 2 I swear that this inventory is a true and detailed account of the property taken by me n this warrant. , / / ,.---. ,.J / 1., / JonAthan 0. Allen EP Enforc. ent off ic.r Subscribed, sworn before me, and returned to me on this date 7/2 7/i ’3 ___ . Date U.S. Magistrate £ d 988 2B29 0.1. .LS3d 3 XOj. 111 N0I93 WQ St:ST 686L’5 ,BØ ------- IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF FLORIDA IN THE MATTER OFI ) ) Basso Chemical Inc., ) Application for Warrant 3211 Powers Avenue ) to Enter, Inspect and Samp. Jacksonville, FL 32207 ) Pursuant to Section 11, of ) the Toxic Substances Contri ) Act, 15 U.S.C. Section 261( ) CO1 ES NOW the Administrator of the United State. Environmental. Protection Agency (EPA), by and through U.S. Attorney, and applie, for a warrant pursuant to and accordance with Section 12. of the Toxic Substances Control Act, 15 U.S.C. S2610, for the purpose of enabling duly authorized EPA enforcement personnel to enter upon the premises of and to conduct an administrative inspection of Basso Chemical Inc., of Jacksonville, Florida as follows. To inspect all. processes, operations, and facilities; to inspect and s.Lzs and/or copy all records, files and papers regarding manufacture, processing, distribution, sal., packaging, transportation, storage and/or disposal of chemical substances associated with the premise.; and to inspect and sample any or all chemical substances or mixtures within the premises or in/on conveyances used to transport such chemical substances or mixtures at or near the premises to determine whether th• requirements of the Toxic Substances Control Act appitcabi. to the facility and/or th. chemical substances and mixtures hay, been complied with. ------- —2- This warrant is Sought under Section 11 of the Toxic Substances Control Act, 15 U.S.C. 5 2610 which provides, in pertinent part 2 (a) In Gen.ral. For purposes of adiuinist.rin this Act, the Administrator, end any duly designate representative of the Administrator, may inspect any establishment, facility, or other premises in which chemical substances or mixtures ar. manufactured, processed, stored, or held before or after their distribution in commerce. Such an inspection may only be made upon the presentation of appropriate credentials and of a written notice to the owner, operator, or agent in charge of th. premises or conveyance to be inspected. A separate notice shall be given for each such inspection, but a notice shall not be required for each entry made during he period covered by the inspection. each such inspection shall be commenced and completed with reasonable promptness and shall be conducted at reasonable times, within reasonable limits, and in a reasonable manner. (b) Scope.-.(1) !xcept as provided in paragraph (2), an inspection conducted under aubsectio (a) shall extend to all things within the premises or conveyance inspected (including records, files, papers, processes, controls, and facilities) bearing on whether the requirements of this Act applicable to the chemical substances or mixtures within such premises or conveyance have bs.n complied with. (2) No inspection under Subsection (a) shall extend to—.. (A) financial data (8) sales data (other than shipment data), (C) pricing data (D) personnel data, or (5) research data (other than data required by this Act or under a rule promulgated thereunder), unless the nature and extent of such data are described with resonabi. specificity in the written notic• required by subsection for such insp.ction.... ------- —3— Basso Chemical Inc. is engaged in the business of manufacturing, processing, selling, distributing, storing and/or disposing of chemical substance, and mixtures, as these term. are defined in Section 3 of the Act. This warrant is required in order to obtain information necessary for EPA to adequately discharge its responsibilities under the Toxic Substances Control Act, Section 313, 15 U.S.C. _________ _________ and to ensure that —. The inspection will be conducted at a reasonabi. time by duly authorized enforcement officers of the U.S. !nvirorunental Protection Agency, Region IV, as icon as practicabl. after issuance of thi. warrant and will be of such duration as to allow the inspectors to satisfactorily complete the inspection. WHERSYORS, EPA requests that a warrant to enter, inspect, and sample, and copying of records from the above-referenced property be issued for the purposes stated herein. ------- —4— In support of this application, the Regional Administrator respectfully submits th. accompanying affidavit and proposed warrant. Respectfully Submitted, United States Attorney By, — - — Assistant U.S. Attorney Northern District of Florida Of Counsel. Edwin Schwarts Assistant Regional Counsel U.S. Environmental Protection Agency 345 Courtland Street, LW. Atlanta, Georgia 30365 ------- IN THE UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF FLORIDA IN THE MATTER OP. Basso Chemical Inc. AFFIDAVIT IN SUPPORT OP APPLICATION FOR WARRANj STAT! OF FLORIDA COUNTY OP DUVAL Donald Stack being duly sworn upon his oath, according to law, deposes and says. 1. I am a duly authorized enforcement officer of Region IV, United States Environmental Protection Agency. I hereby apply for a warrant pursuant to Section 11 of the Toxic Substances Control Act (the Act), 15 U.S.C. 2610, for the inspectiøit, copying, and sampling of th• items namöd below in the possession, custody, or control of Basso Chemical Inc. on the premises or in/on conveyances utilized in th. transport of chemical substances or mixtures at or near the premises locatd at 3211 Powers Avenue, Jacksonville, Florida. To inspect all processes, controls, and facilities; to inspect and copy all records, files, and papers; and to inspect and eampi. any or all, chemical substances or mixtures wLthin the premises or in/on conveyances utilized in the transport of chemical substances or mixtures at or near th. premises bearing on whether the requirements of the Toxic Substances Control Act applicable to the chemical subetenc.. and mixtures hays been complied with. The above data should include inspection of all processes, controls, and facilities; inspection and copying of all records, files, and papers bearing on or relating to the ------- sale, handling, packaging, transportation, storage and/or disposal of polycttlorirtated biphenyls(PCBs) in any form during the periodof April 18, 1978 through the present; and inspection and sampling of all PCB chemical substances, PCB mixtures, PCB articles, and PCB containers located at the premises or in/on conveyances utilized in the transport of chemical substance, or mixtures at or near the premises. 2. This warrant is sought under Section 11 of the Act, 15 U.S.C. 2610, which provides in pertinent parts SEC. 11 INSPECTIONS AND SUBPOENAS. (a) In General.-—For purposes of administering this Act, the Administrator, and any duly designated representative of the Administrator, may inspect any establishment, facility, or other premises in which chemical substances or mixtures ax. manufactured, processed, stored, or held before or after their distribution in coimserce. Such an inspection may only b. made upon th. presentation of appropriate credentials and of a written notic. to the owner, operator, or agent in charge of th. premise. or conveyanc• to be inspected. A separate notice shall be given for each such inspectton,b Ut a notice shall not be required for each entry made during the period covered by the inspection. Each such inspection shall be caim encd and completed with reasonable promptness and shall be conducted at reasonable times, within reasonable limits, and in a reasonable manner. (b) Scops.--.(l) Except as provided tn paragraph (2), an inspection conducted under subsection (a) shall extend to all thing. within th. premises or conveyance inap.cted (including records, files, papers, processes, controls, and facilities) bearing on whether the requirements of this Act applicabl, to the chemical substances or mixtures within such premises or conveyance hev• been complied with. (2) No inspection under subsection (a) shall extend to-. (A) financial data, (8) sales data (other than shipment data), (C) pricing data, (D) personnel data, or (!) research data (other than data required by this Act or under a rule promulgated there- under), ------- unless the nature and extent of such data are described with reasonable specificity in the written notics required by subsection (a) for such inspection... 3. Basso Chemical Inc. is engaged in the business of manufacturing, processing, selling, distributing, and/or disposing of chemical substances and mixtures. 4, This warrant is required in order to obtain information necessary to - 5. The inspection will, begin as soon as practicable after issuance of this warrant and will be conducted with reasonable promptness but continuously and without interruption until completed. 6. The enforcement officer may be accompanied by one or more other employees of the United States Bnvironmental Protection Agency. 7. Th• enforcement of fic.r requests immediate entry to Basso Chemical Inc. to perform the inspection. 8. A return will be made to th. court at the completion of the inspection. 9. The authority for the issuanc. of th inspection warrant is Section 11 of ths Act, 15 U.S.C. 2610, Barlow’s. Inc. , 98 8.Ct. 1816, — — ‘ “- ‘ • rf ‘r’’ ’ Donald Stack Assistant Regionel Counsel US !PA, Region IV ------- IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF FLORIDA IN THE MATTER OFi aseo Chemical Inc. WARRANT FOR INSPECTION DER T} TOXIC SUBS NCE CONTROL AC To $ Donald Stack, Canton HaLley, and Jill Perry, Enforcement Officers, U. S. Environmental Protection Agency, Region IV; Application having been mad. and probable caus. shown, by the U. 5. Attorney for the Northern District of Florida, for a warrant to enter, inspect and sample the establishment described ass Saab Chemical Inc. 3211 Powers Avenue Jacksonville, FL 32207 Pursuant to the Toxic Substances Control Act, 15 U.S.C. 2610, and the decisione of the Supreme Court in Marshall V. arlow! s Inc.. , 98 S.Ct. 1816, —— —— ______________ — you are authorized to imeediately enter the above - described premises upon presentation of this warrant at reasonable times during business hours to inspect all processes, controls, and facilities; to inspect and copy all records, files, and papers regarding manufacture, processing, distribution, sal., packaging, transportation, storage and/or disposal of chemical substances associated with the premises; and to inspect and sample. any and/or all chemical substances or mixtures within the premises or in/on any conveyance utilized in the transport of chemical subitancea or mixtures at or near the premises to determin, whether th. requirement. of the Toxic Substances Control Act applicabi. to the facility and/or the chemical substances or aixturee have been complied with. rh. duration of th. inspection shall be of such a length as to enable the above-named enforcement officers to utiefactorily complete the inspection. DATEDs ___________ - — JUDGI Inspection of the establishment described in this warrant was completed on - — . ------- S ------- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY Washington, D.C. INRE: ) ) BASF CORPORATION and ) Docket No. TSCA—87—H-05 RASP INMONT DIVISION ) ) ________________) AGREEMENT IN PRINCIPLE In settlement of the above captioned matter, the parties agree to the following specific terms and conditions to be in- corporated into a Consent Agreement and Proposed Order of the Administrator within ten (10) calendar days from the date of execution of this agreement. 1. Implementation of a TSCA compliance program f or all BASF Group Exports to the United States; a specific description of the program to be in- corporated into the Consent Agreement. 2. Initiation of a TSCA audit to determine the compliance status of all chemical substances imported by RASP into the United States, such survey to be completed within 180 days of the -entry of the Final Order. Violations of TSCA discovered during the audit to be reported to EPA in writing within ten (10) calendar days of discovery. Stipulated penalties to be established for each reporting deadline. 3. Development and implementation of a comprehensive training program on TSCA compliance for all BASF North American operations, as well a. appropriate RASP Group companies worldwide. 4. Purchase of suitable advertisements in five national trade publications promoting TSCA compliance, the t•xt and selection of publications to be subject to th. advance approval by EPA. Such approval will not b unreasonably withheld. 5. Conduct of two seminars on TSCA compliance in West Germany in conjunction with the West German Manufacturing Association (VCI), with agendas, attendance lists and summary reports to be provided to EPA. ------- —2— 6. Preparation and implementation of a corporate—wide TSCA compliance manual providing detailed guidelines for indivduals routinely involved with TSCA issues. A copy of the manual to be provided to EPA. 7. Submission of a final audit report within 210 days of entry of the Final Order. For violations disclosed within the timeframe provide in paragraph 2 above, involving chemicals or chemical substances under TSCA Sections 5, 8, or 13 that do represent a substantial risk to health or the environment, BASF will pay the sum of $10,000 per chemical or chemical substances as a maximum stipulated penalty. For any chemicals or chemical substances not reported within ten days or for chemicals that represent a substantial risk to health or the environment under Sections 5, 6, 8 or 13 of TSCA, EPA reserves the right to seek a penalty in accord with its published guidelines. Stipulated penalties to be provided for each deadline. 8. EPA reserves its right to initiate administrative or judicial enforcement action under TSCA Sections 7 or 17 to abate an imminent and substantial en— dangerment to human health or the environment. 9. BASF will certify that it has achieved compliance with TSCA within 240 days of entry of the Final Order. 10. Within 20 days of the enrty of the Final Order, BASF will pay a civil penalty of $1,281,950 for the violations recited in the complaint. FOR COMPLAINANT, U.S. EPA FOR RESPONDENT BASF CORPORATION DATED: ------- T ------- - UNITFD STATES ENVIRONMENTAL PROTECTION AGENCY In the Matter of ) 3-V CHEMICAL CORPORATION ) Charlotte, NC ) Responde nt, ) Docket No. TSCA 89-H—17 Notice of Treatment of Confidential Business Information Portions of the attached Complaint require use of information which Respondent submitted to the United States Environmental Protection Agency (EPA) as Confidential Business Information (CBI). Information in the Complaint constituting or based on CBI has been deleted as indicated by the following: (CBI deleted). The original complaint containing C I is filed with the Headquarters Hearing Clerk. It will itself be treated as confidential unless Respondent waives confidentiality thereto or EPA releases the information in accordance with 40 C.F.R. Part 2. ------- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY In the Matter oft- ) 3-V CHEMICAL CORPORATION ) Charlotte, NC ) Responden t, ) Docket No. TSCA—89—H—17 COMPLAINT AND NOTICE OF OPPORTUNITY FOR HEARING UNDER SECTION 16(a) OF THE TOXIC SUBSTANCES CONTROL ACT COMPLAI NT This is a civil administrative action issued under the authority of Section 16(a) of the Toxic Substances Control Act, 15 U.S.C. 2601 et !S• (hereinafter “TSCA”). The Complainant is Michael F. Wood, Director, Compliance Division, Office of Compliance Monitoring, Office of Pesticides and Toxic Substances, United States Environmental Protection Agency (EPA), who has been duly delegated the authority to institute this action. The Respondent is the 3-V Chemical Corporation, 7422 Carmel Executive Park, Charlotte, NC 28226. This Complaint serves as notice that Complainant has reason to believe that Respondent manufactured (imported) and used for commercial purposes chemical substances in violation of Section 5 of TSCA, 1.5 U.S.C. SectIon 2604, Section 13 of TSCA, 15 U.S.CI. Section 2612, Section 4 of TSCA, 15 U.S.C. Section 2603, Section 12 of TSCA, 15 U.S.C. Section 2611, and Section 15 of TSCA, 15 U.S.C. Section 2614, as follows: ------- —2— COUNT I 1. On or about (CBI deleted), Respondent submitted a Premanufactute Notification (PMN), subsequently identified as PMN (CBI deleted) , to the EPA for the chemical substance, (CBI deleted), hereinafter designated as Chemical A. 2. On (CBI deleted), Respondent provided EPA with records revealing that Respondent had manufactured (imported) Chemical A prior to their submission of the PMN. 3. An examination of Respondent’s submitted information revealed that beginning on (C8I deleted), and continuing to (CBI deleted), Respondent imported Chemical A on (CBI deleted) different days. The total importation during this period was (CBI deleted). 4. Information provided to EPA by the Respondent revealed that the chemical substance mentioned in Paragraph 1 was manufactured (imported) for use in the production of (CBI deleted). ------- —3— 5. During the period between (CEI deleted) and (CBI deleted), Chemical A did not appear on the list of chemical substances ul’aintained by the Administrator pursuant to 15 u.s.c. 2607. On (CBI deleted) Respondent submitted to EPA a Notice of Commencement (NOC) for Chemical A. The NOC for Chemical A was received and placed on the TSCA Inventory by the EPA on (CBI deleted) 6. Respondent imported the chemical substance and is considered a manufacturer under Section 3(7) of TSCA, 15 U.S.C. 2602(7). ‘. Respondent failed to submit a notice to the Administrator of EPA of its intention to manufacture (import) Chemical A during the period stated in Paragraph 3. 8. Section 5(a)(1) of TSCA, 15 U.S.C. 2604(a) (1), provides that no person may manufacture (import) a chemical substance which does not appear on the TSCA Chemical Substance Inventory without submitting a notice to the Administrator of EPA at least 90 days before manufacturing (importing) such substance, Section 15(1) (B) of TSCA, 15 U.S.C. 2614(1) (B), provides that it is unlawful for any person to fail to comply with any requirement prescribed by Section 5. ------- —4— Section 15(3)(B) of TSCA, 15 U.S.C. 2614(3) (B), provides that it is unlawful for any person to fail to submit information required by the Act. 9. Respondent is a “person” within the meaning of 40 CFR Part 720.3(x). 40 CFR Part 720 sets forth EPA ’s regulations regarding TSCA Section 5(a)(l) Premanufacture Notification. 10. The conduct described in Paragraphs 2 through 7 above was in violation of Section 5(a)(1), Section 15(l)(B), and Section 15 (3) (B) of TSCA in that Respondent failed to submit a notice to the Administrator of EPA at least 90 days before manufacture (import) of the chemical substance as required. ------- —5— COUNT II 11. Paragraphs 1 and 2 of Count I are incorporated and realleged, as if fully set forth herein. 12. An examination of Respondent’s submitted information revealed that beginning on (CBI deleted) and continuing to (CBI deleted), Respondent imported Chemical A on (CBI deleted) different days and furnished a written statement to the U.S. Customs Service certifying that Chemical A was not being offered for entry in violation of TSCA. 13. During the period stated in Paragraph 12, Chemical A was not on the TSCA Inventory of Chemical Substancese Chemical A was not placed on the TSCA Inventory until (CBI deleted), which is the date EPA received Respondent’s NOC for PMN (CBI deleted). 14. Section 5(a)(1) of TSCA, 15 U.S.C. 2604(a) (1), provides that no person may manufacture (import) a chemical substance which doe8 not appear on the TSCA Chemical Substance Inventory without submitting a notice to the Administrator of •EPA at least 90 days before manufacturing (importing) such substance. ------- —6— 5. Section 13(b) of TSCA, 15 U.S.C. 2612(b) requires the Secretary of the Treasury to issue rules for the administrati9.n of Section 13(a) which provides for the entry of chemical substances into the customs territory of the United States. The Customs rule at 19 CFR Part 12, Sections 12.118 through 12.127, issued under Section 13(b) provides that the importer of a chemical substance shall certify to the district director at the port of entry that the chemical substance being offered for entry is not: subject to TSCA; or in violation of TSCA or any applicable rule thereunder. 16. Section 15(3)(B) of TSCA, 15 U.S.C. 2614(3) (B), provides that it is unlawful to fail to submit information as required by this Act or rule thereunder. 17. Respondent’s certification to the district director at the port of entry that Chemical A was not in violation of TSCA did not represent the true compliance status of Chemical A. 18. The conduct described in Paragraphs 11 through 13 above was in violation of Section 13(b) and Section 15(3)(B) of TSCA, in that Respondent failed to submit a certification to the district director at the port of entry adequately representing the true compliance status of Chemical A, as required. ------- —7— COUNT III 19. Section 4 of ‘1’SCA, 15 U.S.C. 2603, authorizes EPA to require manufacturers (including importers) and/or processors of identified chemical substances and mixtures to test chemicals to develop health and environmental effects data. 20. On October 10, 1904, EPA promulgated a final Phase I test rule for l,1,l—trichloroethane (CAS # 71—55—6), 40 CFR Part 799.4400. The rule became effective on November 23, 1984. 21. 40 CFR Part 799.4400(c) requires that (aill persons who manufacture (import) or process l,],l—trichloroethane...from November 23, 1984, to the end of the reimbursement period shall submit letters of intent to test, exemption applications...and shall conduct tests and submit data as specified in this section, Subpart A of this part and Part 790 of this chapter.... 22. The end of the reimbursement period is considered by the Agency to be five years after the last final report is submitted or an amount of time equal to that which was required to develop data if more than five years after the submission of the last final report required under the test rule. The last final report for l,l,l—trichloroethane was received by the EPA on June 30, 1987. ------- —8— 3. 40 CFR Part 790.45(a) provides that no later than 30 days after the effective date of a test rule described in 40 CFR Part 790.40, each person subject to that rule and required to comply with the requirements of that rule as provided in 40 CFR Part 790.42(a) must, for each test required, either notify EPA by letter of his or her intent to conduct testing or submit an application for an exemption from testing requirements for he test. 24. 40 CFR Part 790.45(d) (1) provides that any person who was not manufacturing (importing) or processing the subject chemical as of or within 30 days of the effective date of the test rule, must submit the letter of intent to test or exemption application by the date manufacture (importing) or processing begins. 25. On or about November 15, 1985, Respondent imported into the United States 37,478 lbs . of 1,1,1—trichioroethane. Respondent did not submit an application for exemption from the testing required by 40 CFR Part 799.4400 and 40 CFR Part 790.45(d) (1). 26. OnAugust 6, 1987, Respondent provided EPA with an application for exemption from testing for the chemical substance, 1,1,1—trichioroethane. ------- —9— 27. Respondent’s late submission of the application for exemption from testing, as alleged in Paragraph 25 above, constitutes a failure or refusal to comply with 40 CFR Parts 790.40, 79.0.45, and 799.4400, which is a violation of Section 4 and Sections 15(1) (A) and 15(3) (B) of TSCA. COUNT IV 28. Paragraph 19 of Count III is incorporated and realleged, as if fully set forth herein. 29. On May 23, 1985, EPA promulgated a final Phase I test rule for Diethylenetriamine (DETA) (CAS * 111—40—0) , 40 CFR Part 799.1575. The rule became effective on July 8, 1985. 30. 40 CFR Part 799.1575(b) requires that (aill persons who manufacture (import) or process diethylenetriamine...from July 8, 1985, to the end of the reimbursement period shall submit letters of intent to test, exemption applications...and shall conduct tests and submit data as specified in this section, Subpart A of this part and Part 790 of this chapter.... ------- — 10 — 31. The end of the reimbursement period is considered by the Agency to be five years after the last final report is submitted or an amount of time equal to that which was required to develop data if more than five years after the submission of the last final report required under the test rule. The last final report for diethylenetriamine has not been submitted to the EPA as of the date of this Complaint. 32. 40 CFR Part 790.45(a) provides that no later than 30 days after the effective date of a test rule described in 40 CFR Part 790.40, each person subject to that rule and required to comply with the requirements of that rule as provided in 40 CFR Part 790.42(a) must, for each test required, either notify EPA by letter of his or her intent to conduct testing or submit an application for an exemption from testing requirements for the test. 33. 40 CFR Part 790.45(d) (1) provides that any person who was not manufacturing (importing) or processing the subject chemical as of or within 30 days of the effective date of the test rule, must submit the letter of intent to test or exemption application by the date manufacture (Importing) or processing begins. ------- — 11 — 34. On or about September 25, 1985, Respondent imported into the United States 9,524 lbs . of (DETA). Respondent did not submit an application for exemption from the testing required by 40 CFR Part 799.1575 and 40 CFR Part 790.45 Cd) (1) 35. On August 6, 1987, Respondent provided EPA with an application for exemption from testing for the chemical substance, (DETA). 36. Respondent’s late submission of the application for exemption from testing, as alleged in Paragraph 34 above, constitutes a failure or refusal to comply with 40 CFR Parts 790.40, 790.45, and 799.1575, which is a violation of Section 4 and Sections 15(l)(A) and 15(3)(B) of TSCA. COUNT V 37. Section 12(b) of TSCA, 15 U.S.C. 2611 and 40 CFR Part 707.60, requires any person who exports or intends to export to a specific foreign country a chemical substance or mixture subject to certain actions pending under Sections 4, 5, 6, or 7 of TSCA, to submit a 12(b) export notice to the EPA as required. a ------- — 12 — 38. Under 40 CFR Part 707.65, this notice must be for the first export or intended export to a particular country in a calender year, and must be postmarked within seven days of forming the intent to export or on the date of export, hichever is earlier. 39. Under 40 CFR Part 707.67, the notice must include: the name of the chemical, the name and address of the exporter, the country of export, the date of export, and the applicable section of TSCA. 40. Paragraphs 19 and 20 of Count III are incorporated and realleged, as if fully set forth herein. 41. On or about (CBI deleted), Respondent submitted to EPA a 12(b) export notice, listing the exports from (CBI deleted) through (CBI deleted), for a product that contained a chemical substance, 1,1,1—Trichioroethane, that is regulated under Section 4 of TSCA. 42. Respondent’s failure to submit the 12(b) export notice as required under 40 CFR Parts 707.60 and 707.65 is a violation of Section 12 and Section 15(3)(B) of TSCA, 15 U.S.C. 2614 (3) (B). ------- — 13 — PROPOSED CIVIL PENALTY Section 16 of TSCA, 15 U.S.C. Section 2615, authorizes the assessment of a civil penalty of up to $25,000 per day for each violation of TSCA. Based upon the facts alleged in this Complaint, and upon the nature, circumstance, extent and gravity of the violations alleged, as well as Respondent’s history of prior violations of TSCA, the degree of culpability and such other matters as justice may require, the Complainant proposes that Respondent be assessed the following civil penalty for the violations alleged in the Complaint: COUNT I Failure to notify of intention to manufacture (import) a chemical substance not on the TSCA Inventory...............$ 50,000 15 U.S.C. 2604(a) (1) 15 U.S.C. 2614(1) (B) 15 U.S.C. 2614(3) (B) COUNT II Failure to provide a certification statement to the district director at the port of entry adequately representing the true compliance status ofachemicalsubstance...........................$ 50,000 15 U.S.C. 2604(a) (1) 15 U.S.C. 2612(b) 15 Li.S.C. 2614(3) (B) ------- — 14 — COUNT III Failure to submit letter of intent to test or a valid request for exemption from testingas required..........................$ 25,000 15 U.S.C. 2603(c) 15 U.S.C. 2614(1) (A) 15 U.S.C. 2614(3) (B) COUNT IV Failure to submit letter of intent to test or a valid request for exemption from testing as required.................. $ 25,000 15 U.S.C. 2603(c) 15 U.s.c. 2614(1) (A) 15 U.S.C. 2614(3) (B) COUNT V Failure to submit a 12(b) export notice as required..... .. .. .. . . . .... .. . . .. .. . . .... . . ........$ Notice of - Noncompliance 15 U.S.C. 2611 15 U.S.C. 2614(3) (B) TOTALS...... . . . . . . . . . . . . .$ 150,000 ------- — 15 — ADJUSTMENTS TO PROPOSED PENALTY Because Respondent voluntarily disclosed to EPA the violations alleged in the Complaint, Complainant is adjusting the proposed penalty downward twenty—five percent. ADJUSTED TOTAL PROPOSED CIVIL PENALTY ......$ 112,500 NOTICE OF OPPORTUNITY TO REQUEST A HEARING As provided in Section 16(a) (2) (A) of TSCA, and in accordance with 554 of Title 5, United States Code, you have the right to request a formal hearing to contest any material fact set forth in this Complaint or to contest the appropriateness of e proposed penalty. To avoid being found in default and having the above—cited penalty assessed without further proceedings, you must file a written Answer within twenty (20) days of your receipt of this Complaint. Your Answer should (1) clearly and directly admit, deny, or explain each of the factual allegations’ contained in this Complaint, (2) briefly state all facts and circumstances, if any, which constitute grounds for a defense, and (3) specifically request an administrative hearing (if desired). The denial of any material fact or the raising of any affirmative defense shall be construed as a request for a hearing. Failure to deny any of the factual allegations in this Complaint will constitute an admission of the undenied allegations. The Answer should be sent to: ------- — 16 — Headquarters Hearing Clerk (A—hO) United States Environmental Protection Agency 401 M Street, S.W., Room 3706 WashIngton, DC 20460 The hearing which will be held upon your request will be conducted in accordance with the Administrative Procedure Act (5 U.S.C. Section 551 et seq. ) and the “Consolidated Rules of Practice Governing the Administrative Assessment of Civil Penalties and the Revocation or Suspension of Permits” 40 CFR Part 22 (45 FR 24360). A copy of the Consolidated Rules accompanies this Complaint. INFORMAL SETTLIEMENT CONFERENCE Whether or not you request a hearing, you may confer informally with EPA to discuss the facts of this case, or amount of the proposed penalty, and the possibility of settlement. An informal settlement conference does not, however, affect your obligation to file a written Answer to the Complaint. EPA has the authority to modify the amount of the proposed penalty, where appropriate, to reflect any settlement reached with you in an informal conference. The terms of such an agreement would be embodied in a Consent Agreement and Final Order. A Consent Agreement signed by EPA and yourself would be binding as to all terms and conditions specified therein. ------- — LI — Any requests for an informal conference, copies of all 1 ocuments to be filed by Respondent, including the Answer, and any other questions that you may have regarding this Complaint should be directed-to: Mr. Vincent Giordano, Attorney Toxics Litigation Division (LE—134—P) U.S. Environmental Protection Agency 401 M Street, S.W. Washington, DC 20460 (202) —475—8693 PAYMENT OF PENALTY Instead of filing an Answer requesting a hearing or requesting an informal settlement conference, you may choose to ay the proposed penalty. Such payment should be made by sending to the Headquarters Hearing Clerk’s address listed below a cashier’s or certified check in the amount of the penalty assessed in this Complaint. Your check must be made payable to the United States of America and sent to: EPA—Washington (Hearing Clerk) P.O. Box 360277M Pittsburgh, PA 15251 . ------- — 18 — UNITED STATES ENVIRONMENTAL PROTECTION AGENCY TSCA 89—H—17 Complainant BY.: 1 A / k ” 1 Michael F. Wood, Director Compliance Division Office of Compliance Monitoring Date: _________________ ------- — 19 — CERTIFICATION I hereby certifythat the original of the foregoing Complaint and Notice of Opportunity for Hearing, Docket No. TSCA—89—H—17, has been filed with the Headquarters Hearing Clerk and that copies were sent, registered mail, return receipt requested to: Mr. Michael R. Cusano, General Manager 3-V Chemical Corporation 7422 Carmel Executive Park Charlotte, NC 28226 iL /I / cLc L Date John E. Mason (EN—342) Document Control Officer U.S. Environmental Protection Agency 401 M Street, S.W. Washington, D.C. 20460 ------- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY C.,. IN THE MATTER OF: ) TPEMCO, INC. ) INCON DIVISION ) BARROURVILLE, KENTUCKY ) Respondent. ) Docket No. TSCP 88-H-05 Notice of Treatment of Confidential Business Information Portions of the attached Second Amended Complaint require use of information which Respondent submitted to the United States Environmental Protection Agency (EPA) as Confidential Rusiness Information (CR1). Information in the Complaint constituting or based on CBI has been deleted as indicated by the following: (CR1 deleted). The original Second Amended Complaint which contains CR1 is filed with the Headquarters Hearing Clerk. It will itself he treated as confidential unless Pespondent waives confidentiality thereto or EPA releases the information in accordance with 40 C.F.R. Part 2. ------- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY IN THE MATTER OF: ) TREMCO, INC. ) INCON DIVISION ) BARBOURVILLF, KENTUCKY ) Respondent ) ) Docket No. TSCA—8 -H—Q5 COMPLAINT AND NOTICE OF OPPORTUNITY FOR HEARING UNDER SECTION 16(a) OF THE TOXIC SUBSTANCES CONTROL ACT SECOND AMENDED COMPLAINT This is a civil administrative action issued under the authority of Section 16(a) of the Toxic Substances Control Act, 1 u.s.c. 2601 et (hereinafter “TSCA”). The Complainant is Connie P. Musgrove, Chief Executive Officer, Office of Compliance Monitoring, Office of Pesticides and Toxic Substances, United States Environmental Protection Agency (hereinafter “EPA or “the Agency), who has been duly delegated the authority to institute this action. The Respondent is Tremco, Inc., Incon Division Treuhaft Boulevard, Barhourville, Kentucky (hereinafter “Respondent”). This seconded amended Complaint serves as notice that Complainant has reason to believe that Respondent manufactured chemical substances in violation of Section 5 of TSCA, 15 U.S.C. Section 2604, and Section 15 of TSCA, 15 U.S.C. Section 2614, as follows: ------- -2— COUNT 1 1. Respondent is included in the word “Person” as defined in 40 CFR 720.3(x) and as such is subject to TSCA and the regulations promulgated thereunder. 2.. On (CR1 deleted), Respondent submitted information to the Agency revealing that Respondent had manufactured the chemical substance (CR1 deleted), hereinafter known as Chemical A. Chemical A is designated by the Respondent as (CBI deleted), and has also been designated by the Agency as (CR! deleted). 3. On (CR! deleted), Respondent provided the Agency with records covering the production of Chemical A. Based upon this information, Complainant alleged in the original Complaint that Respondent had manufactured Chemical A on 22 separate daily occasions. These allegations were previously alleged in the Complaint as Counts 1 through 22. However, in preparing its response to the Complaint, Respondent determined that the information which was supplied to the Agency in (CR1 deleted) was incomplete. Additional documents reveal that between (CBI deleted) Respondent had manufactured chemical A on at least 41 separate daily occasions. ------- —3— 4. on the dates of manufacture referred to In paragraph 3, Chemical A did not appear on the TSCA Chemical Substance Inventory maintained by the Administrator pursuant to Section 8 of TSCA, 15 U.S.C. 2607. 5. Section S(a)(l) of TSCA, 15 U.S.C. 2604(a)(l), provides that no person may manufacture a chemical substance which does not appear on the TSCA Chemical Substance Inventory, unless such person submits a Preiranufacture Notice to the Administrator of EPA at least 90 days before such manufacture. Respondent’s Prerianufacture Notice for Chemical A was received by the Agency on (CR! deleted). The statutory 90 day review period for Chemical A expired (CR1 deleted). 6. Section l5(l)(B) of TSCA, 15 U.S.C. 2614(1)(B), provides that it is unlawful for any person to fail or refuse to comply with any requirement prescribed by Section 5 of TSCA. 7. The conduct described in paragraph 3 above was in violation of ectlons 5(a)(1) and 15(l)(R) of TSCA, in that Respondent failed to notify the Administrator at least 90 days before the manufacture of Chemical A. ------- —4— COtINT 2 1. Respondent is included in the word “Person” as defined in 40 CFR 720 3(x). and as such is subject to TSCA and the regulations promulgated thereunder. 2. On (CR1 deleted), Respondent submitted information to the Agency revealing that Respondent had manufactured the chemical substance (CBI deleted), hereinafter known as Chemical B. Chemical R is designated by the Respondent as (CBI deleted), and has also been designated by the gency as (CR1 deleted). 3. On (CR1 deleted), Respondent provided the Agency with records covering the production of Chemical B. Based upon this information, Complainant alleged in the original Complaint that Respondent had manufactured Chemical B on 3 separate daily occasions. These allegations were previously alleged in the Complaint as Counts 23 through 25. However, in preparing its response to the Complaint, Respondent determined that the information which was supplied to the Agency in (CR1 deleted) was incomplete. Additional documents reveal that between (CBI deleted) Respondent had manufactured Chemical B on at least 14 separate daily occasions. ------- —5-. 4. On the dates of manufacture referred to in paragraph 3, Chemical B did not appear on the TSCA Chemical Substance- Inventory maintained by the Administrator pursuant to Section 8 of TSC , 15 u.s.c. 2607. 5. Section 5(a)(1) of TSCA, 15 U.S.C. 2604(a)(1), provides that no person may manufacture a chemical substance which does not appear on the TSCA Chemical Substance Inventory unless such person submits a Premanufacture Notice to the Administrator of EPA at least 90 days before such manufacture. Respondent’s Premanufacture Notice for Chemical B was received by the Agency on (CR1 deleted). The statutory 90 day review period for Chemical R expired (CR! deleted). 6. Section ].5(l)(B) of TSCA, 15 U.S.C. 2614(l)(B), provides that it is unlawful for any person to fail or refuse to comply with any requirement prescribed by Section 5 of TSCA. 7. The conduct described in paragraph 3 above was In violation of Sections 5(a)(1) and 15(1)(B) of TSCA, in that Respondent failed to notify the Administrator at least 90 days before manufacturing Chemical B. ------- —6— COUNT 3 1. Respondent is included in the word “Person” as defined in 4fl CFR 720.3(x) and as such is subject to TSCA and the regulations promulgated thereunder. 2. On (CR1 deleted), Respondent submitted information to the Agency revealing that Respondent had manufactured the chenical substance (CR1 deleted), hereinafter known as Chemical C. Chemical C is designated by the Respondent as (CR1 deleted), and has also been designated by the Agency as (CBI deleted). 3. On (CR1 deleted), Respondent provided the Agency with records covering the production of Chemical C. Based upon this information, Complainant alleged in the original Complaint that Respondent had manufactured Chemical C on 32 separate daily occasions. These allegations were previously alleged in the Complaint as Counts 26 through 57. However, in preparing its response to the Complaint, Respondent determined that the information which was supplied to the Agency in (CR1 deleted) was incanpiete. Additional documents reveal that between (CR1 deleted) Respondent had manufactured Chemical C on at least 54 separate daily occasions. ------- —7— 4. On the dates of manufacture referred to in paragraph 3, Chemical C did not appear on the TSCA Chemical Substance Inventory maintained by the Administrator pursuant to Section 8 of TSCA, 15 U.S.C. 2607. 5. Section 5(a)(1) of TSCA, 15 U.S.C. 2604(a)(1), provides that no person may manufacture a chemical substance which does not appear on the TSCA Chemical Substance Inventory, unless such person submits a Preinanufacture Notifice to the Administrator of EPA at least 90 days before such manufacture. Respondent’s Premanufacture Notice for Chemical C was received by the Agency on (CR1 deleted). The statutory 90 day review period for Chemical C expired (CR1 deleted). 6. Section 15(l)(B) of TSCA, 15 U.S.C. 2614(1)(R), provides that it is unlawful for any person to fail or refuse to comply with any requirement prescribed by Section 5 of TSCA. 7. The conduct described in paragraph 3 above was in violation of Sections 5(a)(1) and 15(1)(B) of TSCA, in that Respondent failed to notify the Administrator at least 90 days before manufacturing Chemical C. ------- —8— COUNT 4 1. Respondent is included in the word “Person” as defined in 40 CFR 720.3(x) and as such is subject to TSCA and the regulations promulgated thereunder. 2. On or about (CBI deleted), an inspection of Respondent’s facility located in Rarbourville, Kentucky was performed by authorized employees of EPA pursuant to Section 11 of TSCA. The purpose of the inspection was to determine Respondent’s compliance with TSCA €5 requirements. 3. As a result of the inspection, on (CR1 deleted), Respondent provided EPA with additional information covering the production of Chemical A. 4. The production records that Respondent provided to the Agency reveal that on (CR1 deleted), Respondent produced (CR1 deleted) of Chemical A for commercial purposes. 5. On the date of manufacture referred to in paragraph 4, Chemical A did not appear on the TSCA Chemical Substance Inventory maintained by the Administrator pursuant to Section 8 of TSCA, 15 U.S.C. 2607. ------- —9— 6. Section 5(a)(1) of TSCA, 15 U.S.C. 2604(a)(1), provides that no person may manufacture a chemical substance which does not appear on the TSCA Chemical Substance Inventory unless such person submits a Premanufacture Notice to the Administrator of EPA at least 90 days before such manufacture. Respondent’s Preiranufacture Notice for Chemical A was received by the Agency on (CR1 deleted). The statutory 90 day review period for Chemical A expired (CBI deleted). Respondent manufactured Chemical A on (CR1 deleted). 7. Section 15(l)(B) of TSCA, 15 U.S.C. 2614(1)(B), provides that it is unlawful for any person to fail or refuse to comply with any requirement prescribed by Section 5 of TSCA. 8. The conduct described in paragraph 4 above was in violation of Sections 5(a)(1) and 15(1)(B) of TSCA, in that Respondent failed to notify the Administrator at least 90 days before manufacturing Chemical A. This allegation was previously alleged in the Complaint as Count 58. ------- — in — COUNT 5 1—2. paragraphs 1 and 2 of Count 4 are hereby incorporated by reference a if fully set forth in this Count. 3. As a result of the inspection, on (CR1 deleted), Respondent provided EPA with additional information covering the production of Chemical C. 4. The production records that Respondent provided to the Agency reveal that on (CBI deleted), Respondent produced (CBI deleted) of Chemical C for commercial purposes. 5. On the date of manufacture referred to in paragraph 4, Chemical C did not appear on the TSCA Chemical Substance Inventory maintained by the Administrator pursuant to TSCA Section 8 of TSCA, 15 U.S.C. 2607. 6. Section 5(a)(l) of TSCA, 15 U.S.C. 2604(a)(1), provides that no person may manufacture a chemical substance which does not appear on the TSCA Chemical Substance Inventory, unless such person submits a Premanufacture Notice to the Administrator of EPA at least 90 days before such manufacture. Respondent’s Premanufacture Notice for Chemical C was received by the Agency on (CR1 deleted). The statutory 90 day review-period ------- — 11 — for Chemical C expired (CBI deleted). Respondent manufactured Chemical C on (CM deleted). 7. Section 15(l)(B) of TSCA, 15 U.S.C. 2614(1)(R), provides that it is unlawful for any person to fail or refuse to comply with any requirement prescribed by Section 5 of TSCA. 8. The conduct described in paragraph 4 above was in violation of Sections 5(a)(l) and 15(1)(B) of TSC , in that Respondent failed to notify the dministrator at least 90 days before manufacturing Chemical C. This allegation was previously alleged in the Complaint as Count 59. PROPOSED CIVIL PENALTY Section 16 of TSCA, 15 U.S.C. Section 2615, authorizes the assessment of a civil penalty of up to S25,flOO per day for each violation of TSCA. Based upon the facts alleged in this Complaint, and upon the nature, circumstances, extent and gravity of the violations alleged, as well as Respondent’s history of prior violations of TSCA, the degree of culpability, and such other matters as justice may require, the Complainant proposes that Respondent be assessed the following civil penalty for the violations alleged in this Complaint: ------- — 12 — COUNT 1 Manufacture of a chemical substance on 41 separate daily occasions which did not appear on the TSCA Chemical Substance Inventory. •1• •••, •••• •1 •••••••• • •......... . . . . . . .S1 12,500 15 U.S.C. 2604(a)(l) 15 U.S.C. 2614(l)(B) COUNT 2 Manufacture of a chemical substance on 14 separate daily occasions which did not appear on the TSCA Chemical Substance Inventory .. $ 38,000 15 U.S.C. 2604(a)(l) 15 U.S.C. 2614(1)(B) COUNT 3 Manufacture of a chemical substance on 54 separate daily occasions which did not appear on the TSCA Chemical Substance Inventory. . . . . .......... . . . . ........... . . ....... .S106,500 15 U.S.C. 2604(a)(1) 15 U.S.C. 2 14(l)(R) COUNT 4 Manufacture of a chemical substance which did not appear on the TSCA Chemical Substance Inventory.........S 10,000 15 U.S.C. 2604(a)(l) 15 U.S.C. 2614(1)(B) ------- — 13 — COUNT 5 Manufacture of a chemical substance which did not appear çn the TSCA Chemical Substance Inventc ry.........S 10,000 15 U.S.C. 2604(a)(l) 15 U.S.C. 2614’l)(R) TOTAL PROPOSED PENALTY . ................ ... •1•• .S277,000 ADJUSTMENTS TO PROPflSEI) PENALTY DJUSThENTS TO COUNTS 1 THROUGH 3. Because Respondent voluntarily disclosed to EPA the violations in Counts 1 through 3, Complainant is adjusting the proposed penalty downward twenty—five percent. M)JUSTED PROPOSED PENALTY FOR COUNTS 1 THROUGH 3....... . . . . . . . . . . ........ . . . . . .5192,750 DJUST14ENTS TO COUNTS 4 AND 5. Respondent’s past compliance history includes TSCA Section 5 violations. See docket numbers: TSCA—83—H—07, and Region V case number 409. Therefore, Complainant is adjusting the penalty upwards for Counts 4 and 5 by 100%. ADJUSTED PROPOSED PENALTY FOR COUNTS 4 and S.....S 40,000 TOTAL ADJUSTED PROPOSED PENALTY...... ...... ..... .$232,750 ------- — 14 — NOTICE OF OPPORTUNITY TO RECUEST A HEARING As provided in Section 16(a)(2)(A) of TSCA, and in accordance with-Section 554 of Title 5, United States Code, you have the right to request a formal hearing to contest any material fact set forth in this Complaint or to contest the appropriateness of the proposed penalty. To avoid being found in default and having the above—cited penalty assessed without further proceedings, you must- file a written Answer within twenty (20) days of your receipt of this Complaint. Your Answer should (1) clearly and directly admit, deny, or explain each of the factual allegations contained in this Complaint, (2) briefly state all facts and circumstances, if any, which constitute grounds for a defense, and (3) specifically request an administrative hearing (if desired). The denial of any material fact or the raising of any affirmative defense shall be construed as a request for a hearing. Failure to deny any of the factual allegations in this Complaint will constitute an admission of the undenied allegations. The Answer must be sent to: Headquarters Hearing Clerk (A—llO) United States Environmental Protection Agency 401 M Street, S.W., Room 3706 Washington, DC 20460 The hearing which will he held upon your request will be conducted in accordance with the Administrative Procedure Act ------- — 15 — (5 U.S.C. Section 551 et and the “Consolidated Rules of Practice Governing the Administrative Assessment of Civil Penalties and the Revocation or Suspension of Permits” 40 CFR part 22 (45 FR 24360). A copy of the consolidated Rules accompanies this Complaint. INFORMAL SETTLFJAF.NT CONFERENCE Whether or not you request a hearing, you may confer informally with EPA to discuss the facts of this case, or amount of the proposed penalty, and the possibility of settlement. An informal settlement conference does not, however, affect your obligation to file a written Answer to the Complaint. EPA has the authority to modify the amount of the proposed penalty, where appropriate, to reflect any settlement reached with you in an informal conference. The terms of such an agreement would be embodied in a Consent Agreement and Final Order. A Consent Agreement signed by EPA and yourself would be binding as to all terms and conditions specified therein. Any requests for an informal conference, copies of all documents to be filed by Respondent, and any other questions that you may have regarding this Complaint should be directed to: Mr. Vincent C iordano U.S. Environmental Protection Agency Toxics Litigation Division (LE—134P) Room 113 Northeast Mall 401 14 Street, S .W. Washington, D.C. 20460 (202) 475—8690 ------- — 16 — PAYMENT OF PFNALTY Instead of filing an Answer requesting a hearing or request- ing an informal settlement conference, you may choose to pay the proposed penalty. Such payment should be made by sending to the Headquarters Hearing Clerk’s address listed below a cashier’s or certified check in the amount of the penalty assessed in this Complaint. Your check must he made payable to the United States of America and sent to: EPA—Washington (Hearing Clerk) P.O. Box 360277M Pittsburgh, PA 15251 UNITED STATES ENVIRONMENTAL PROTF.CTION AGENCY Complainant onn e A. Mus rove U Chief Executive Officer Office of Compliance Monitoring (EN—342) NOV - 2 i988 Date: ___________ ------- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY In the Matter of GRIFFTEX CHEMICALS ) Docket No. TSCA 88—11—03 Respondent, Notice of Treatment of Confidential Business Information Portions of the attached Complaint require use of information which Respondent submitted to the United States Environmental Protection Agency (EPA) as Confidential Business Information (CBI). Information in the Complaint constituting or based on CBI has been deleted as indicated by the following: (CBI deleted). The original complaint containing CBI is filed with the Headquarters Hearing Clerk. It will itself be treated as confidential unless Respondent waives confidentiality thereto or EPA releases the information in accordance with 40 C.F.R. Part 2. ------- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY In the Matter of ) GRIFFTEX CHEMICALS ) Respondent, ) Docket NO. TSCA-88--H-03 COMPLAINT AND NOTICE OF OPPORTUNITY FOR HEARING UNDER SECTION 16(a) OF THE TOXIC SUBSTANCES CONTROL ACT COMPLAINT This is a civil administrative action issued under the authority of Section 16(a) of the Toxic Substances Control Act, 15 U.S.C. 2601 et sea. (hereinafter ?TSCA !). The Complainant is Ken Shiroishi, Director, Compliance Division, Office of Compliance Monitoring, Office of Pesticides and Toxic Substances, United States Environmental Protection Agency (EPA), who has been duly delegated the authority to institute this action. The Respondent is Grifftex Chemicals, a facility of west Point Pepperell, Inc., 1900 cunningham Drive, Opelika, Alabama 36801. This Complaint serves as notice that Complainant has reason to believe that Respondent manufactured a chemical substance in violation of Section 5 of TSCA, 15 U.S.C. Section 2604, and Section 15 of TSCA, 15 U.S.C. Section 2614, as follows: ------- —2— COUNT I 1. On June 26, 1986, Grifftex Chemicals, a facility of West Point Pepperell, Inc., located at 1900 Cunningham Drive, ODelika, Alabama, 36801 was inspected by a duly authorized representative of EPA pursuant to Section 11 of TSCA, 15 U.S.C. 2610. 2. This inspection was conducted to determine compliance with TSCA Section 5 and Section 8 requirements. 3. The inspection revealed that Respondent manufactured a chemical substance, (CBI deleted), hereinafter known as Chemical A. 4. A premanufacture notice was submitted to EPA for review of Chemical A on (CBI deleted), and was assigned PMN case number (CBI deleted). 5. The 90—day premanufacturing review process for PMN (CBI deleted) expired on (CBI deleted), as permitted by 40 CFR Section 720.75(a). ------- —3— 6. On (CBI deleted), Respondent submitted a notice of commencement of manufacture for Chemical A as required by 40 CFR..Section 720.102. 7. The notice of commencement of manufacture for Chemical A was received by the Agency and included on the list of chemical substances maintained by the Administrator pursuant to 15 U.S.C. 2607 on (CBI deleted). 8. Inspection of Respondent’s records revealed that the first commercial batch of Chemical A began on (CBI deleted), (CBI deleted) days after the notice of commencement was submitted to the EPA. 9. 40 CFR Section 720.102(b) requires submission of a notice of commencement of manufacture on, or no later than 30 calendar days after the first date of such manufacture. 15 U.S.C. 2614(l)(C) prohibits the violation of any rule promulgated pursuant to Section 5 of TSCA. Section 15(3)(B) of TSCA, 15 U.S.C. 2614(3)(B) provides that it is unlawful for any person to fail or refuse to submit reports, notices, or other information as required by the Act. ------- —4— 10. Respondent violated 40 CFR Section 720.102(b), 15 U.S.c. 2614(1)(C), and 15 U.S.C. 2614(3)(B) by failing to submit a timely notice of commencement to the Administrator of EPA on, or no later than 30 calendar days after the date of such manufacture as required. PROPOSED CIVIL PENALTY Section 16 of TSCA, 15 U.S.C. Section 2615, authorizes the assessment of a civil penalty of up to $25,000 per day for each violation of TSCA. Based upon the facts alleged in this Complaint, and upon the nature, circumstances, extent and gravity of the violations alleged, as well as Respondent’s history of prior violations of TSCA, the degree of culpability and such other matters as Justice may require, the Complainant proposes that Respondent be assessed the following civil penalty for the violations alleged in this Complaint: COUNT I Failure to comply with notice of commencement requirements.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 10 ,000 15 U.S.C. 2604(a)(l) 15 U.S.C. 2614(1)(C) 15 U.S.C. 2614(3)(B) ------- —5— NOTICE OF OPPORTUNITY TO REQUEST A HEARING As provided in Section 16(a)(2)(A) of TSCA, and in accordance with 554 of Title 5, United States Code, you have ‘the right to request a formal hearing to contest any material fact set forth in this Complaint or to contest the appropriate- ness of the proposed penalty. To avoid being found in default and having the above-cited penalty assessed without further proceedings, you must file a written Answer within twenty (20) days of your receipt of this Complaint. Your Answer should (1) clearly and directly admit, deny, or explain each of the factual allegations contained in thisComplaint, (2) brIefly state all facts and circumstances, if any, which constitute grounds for a defense, and (3) specifIcally request an administrative hearing (If desired). The denial of any material fact or the raising of any affirmative defense shall be construed as a request for hearing. Failure to deny any of the factual allegations In this Complaint will constitute an admission of the undenied allegations. The Answer should be sent to: Headquarters Hearing Clerk (A-hO) United States Environmental Protection Agency 401 M Street, S.W. , Room 3706 Washington, DC 20460 ------- -6- The hearing which will be held upon your request will be conducted In accordance with the Administrative Procedure Act (5 U.S.C. SectIon 551 et and the “Consolidated Rules of Practice Governing the Administrative Assessment of Clvii Penalties and the Revocation or Suspension of Permits” 40 CFR Part 22 (45 FR 24360). A copy of the Consolidated Rules accompanies this Complaint. INFORMAL SETTLEMENT CONFERENCE Whether or not you request a hearing, you may confer Informally with EPA to discuss the facts of this case, or amount of the proposed penalty, and the possibility of settlement. An Informal settlement conference does not, however, affect your obligation to file a written Answer to the Complaint. EPA has the authority to modify the amount of the proposed penalty, where appropriate, to reflect any settlement reached with you in an informal conference. The terms of such an agreement would be embodied In a Consent Agreement and Final Order. A Consent Agreement signed by EPA and yourself would be binding as to all terms and conditions specified therein. ------- —7— Any requests for an informal conference, copies of all. documents to be filed by Respondent, including the Answer, and any otherquestions that you may have regarding this Complaint should be directed to: Jon D. Silberman, Attorney Toxics Litigation Division (L E— 134 ) U.S. Environmental Protection Agency 401 M Street, S.W. Washington, D.C. 20460 (202) 475—8694 PAYMENT OF PENALTY Instead of filing an Answer requesting a hearing or requesting an informal settlement conference, you may choose to pay the pro- posed penalty. Such payment should be made by sending to the Headquarters Hearing Clerk’s address listed below a cashier’s or certified check in the amount of the penalty assessed in this Complaint. Your check must be made payable to the United States of America and sent to: EPA—Washington (Hearing Clerk) P.O. Box 360277M Pittburgh, PA 15251 ------- -8- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY Complainant BY: Ken Shiroishi, Director Compliance Division (EPI—342) Date: ------- —9— CERTIFICATIO’ I hereby certify that the original of the foregoing Complaint and Notice of Opportunity for Hearing, Docket tb. TSCA-88-H—03, has been filed with the Headauarters Hearing Clerk and that copies were sent, registered mail, return receipt requested to: Mr. Lee Goodrich West Point — Peoperell, Inc. P.O. Box 7]. West Point, GA 31833 Date John Mason (EN—342) Document Control Officer U.S. Environmental Protection Agency 401 M Street, S.W. Washington, D.C. 20460 ------- UHITED STATES ENVIRONMENTAL PROTECTIOW ENCY REGION V :2” IN RE: ) ) REICNMOLD CHEMICALS, INCORPORATED ) MORRIS, ILLINOIS 60450 ) Docket No. TSCA-V-C— ) TSCAVC ‘89 COMPLAINT Ang - NOTICE OF OPPORTUNITY FOR HEARING I COMPLAINT GENERAL ALLEGATIONS 1. This is a civil administrative action instituted pursuant to Section 16(a) of the Toxic Substances Control Act, 15 U.S.C. 2601 . (hereinafter “TSCA”), 15 U.S.C. § 2615(a), and Sections 22.Ol(a)(5) and 22.13 of the Consolidated Rules of Practice Governing the Administrative Assessment of Civil Penalties and the Revocation or Suspension of Permits, 40 C.F.R. § § 22.Ol(a)(5), 22.13. 2. The Complainant is, by lawful delegation, the Director, Environmental Sciences Division, Region V, United States nvironmenta1 Protection Agency (hereinafter “U.S. EPA”). 4L ------- —2— 3. The Respondent is Reichhold Chemicals, Inc., which is and was at all times relevant to this Complaint, a corporation incorporated under the laws of the State of Delaware, with a place of business at Collins Road, Goose Lake Township, Morris, Illinois 60450. 4. The Chemical Information Rules were lawfully promulgated pursuant to Section 8 of TSCA, 15 U.S.C. § 2607, on June 22, 1982 (47 26992). The Chemical Information Rules have been subsequently amended and are codified at 40 C.F.R. Part 712. 5. Respondent is a “person” as defined in 40 C.F.R. § 712.3(1). 6. On March 10, 1987, a representative of the U.S. EPA conducted an inspection of Respondent’s facility located at Morris, Illinois to determine compliance with the Chemical Information Rules. - COUNT I 7. The General Allegations of the Complaint are incorporated by reference as though set forth here in full. 8. As specified in 40 C.F.R. § 712.30(d) a Preliminary Assessment information (PAl) Manufacturer’s Report for maleic ------- —3— arthydride was required to be submitted to the U.S. EPA by November 19, 1982. - 9. 40 C.F.R. § 712.20 provides that persons who manufactured a chemical substance listed in § 712.30 are required to submit a PAl report for each plant site at which they manufactured the chemical substance during the reporting period specified in § 712.30. 10. According to 40 C.F.R. § 712.30(a)(2) the Report was to have covered the Respondent’s latest complete corporate fiscal year as of the effective date of the Rule. 11. The reporting requirements of § 712.30(d) were effective on July 22, l982.f The Respondent’s latest complete corporate fiscal year as of this date was from January 1, 1981 to Decembe J 31, 1981. 12. The Respondent, in writing, notified U.S. EPA on July 26, 1982, that they no longer manufactured maleic anhydride. 13. During the March 10, 1987, inspection, the EPA representative determined that Respondent had manufactured maleic anhydride during the reporting period and was required by 40 C.F.R. Part 712 to submit a timely and complete PAt report for this substance for the Morris, Illinois facility. ------- —4— 14. The Respondent failed to submit a PAl Report for maleic anhydride, contrary to 40 C.F.R. Part 712, and in violation of Section 15(3) of TSCA, 15 U.S.C. § 2614(3). II PROPOSED CIVIL PENALTY Section 16 of TSCA, 15 U.S.C. Section 2615, authorizes the assessment of a civil penalty of up to $25,000 per day for each violation of TSCA. Based upon the facts alleged in Part I of this Complaint, and upon the nature, circumstances, extent and gravity of the violations alleged, as well as Respondent’s history of prior violations of TSCA, the degree of culpability, and such other matters as justice may require, the Complainant proposes that Respondent be assessed the following civil penalty for the violations alleged in this Complaint. COUNT I Failure to submit a report in the manner required by a TSCA Rule $13,000 15 U.S.C. § 2614 40 C.F.R. Part 712 TOTALPENALTY . . . . . . . . . . . . .$l3,000 Payment of this penalty may be made by certified or cashier’s check payable to “Treasurer, the United States of America,” and remitted to: ------- —5— U.S. Environmental Protection Agency, Region V P.O. Box 70753 Chicago, Illinois 60673 A cony of the check shall be sent to: Branch Secretary Pesticides & Toxic Substances Branch, (5SPT—7) U.S. Environmental Protection Agency 230 South Dearborn Street Chicago, Illinois 60604 A transmittal letter identifying this Complaint shall accompany the remittance and copy. The penalties proposed in Part II of this Complaint were derived by applying the factors enumerated above to the particular allegations that constitute the violations charged in this action. The reasoning for each assessment is explained in detail in the “Guidelines for Assessment of Civil Penalties Under Section 16 of the Toxic Substances Control Act,” which appears in the Register of September 10, 1980, at 45 ad. Egg. 59770. III OPPORTUNITY TO REOUEST A HEARING As provided in TSCA Section 16(a) arid in accordance with the Administrative Procedure Act (5 U.S.C. ç 552 gt gg.), you have the right to request a hearing regarding the Complaint, to contest any material fact contained in the Complaint, or to contest the appropriateness of the amount of the proposed penalty. If you wish to avoid being found in default, you must file a written Answer to this Complaint and a Request for Hearing with the Regional Hearing Clerk (5MFA-14), U.S. Environmental ------- —6— Protection Agency, Region V, 230 South Dearborn Street, Chicago, Illinois 60604, within twenty (20) days of service of this Complaint. The Answer must clearly and directly admit, deny or explain each of the factual allegations contained in the Complaint with respect to which Respondent has any knowledge, or clearly state that Respondent has no knowledge as to particular factual allegations in the Complaint. The Answer shall also state: 1. The circumstances or arguments which are alleged to constitute grounds of defense; 2. The facts which Respondent intends to place at issue. The denial of any material fact or the raising of any affirmative defense shall be construed as a request for a hearing. Failure to deny any of the factual allegations in this Complaint constitutes admission of the undenied allegations. A co v of this Answer and any subsequent documents filed in this action should be sent to Mr. Vincent Giordano, Attorney-Advisor, LE-134P, U.S. Environmental Protection Agency, 401 M Street, SW, Washington, D.C. 20460. Mr. Giordano may be telephoned at (202) 475—8693. Any hearing that you request will be held and conducted in accordance with the provisions of the Administrative Procedure Act (5 U.S.C. • 552 g.) and the Consolidated Rules of Practice Governing Administrative Assessment of Civil Penalties and the Revocation or Suspension of Permits, 40 C.F.R. Part 22. A copy of these rules accompanies this Complaint. If you fail to file a written Answer and Request for Hearing within twenty (20) days of service of this Complaint, a Default ------- —7— Order may thereafter be issued by the Regional Administrator. As Respondent, your default constitutes a binding admission of all allegations made- in the Complaint and a waiver of your right to a hearing under TSCA. The civil penalty proposed herein shall then become due and payable without further proceedings. Such Default Order is not subject to review in any court. In addition, the default penalty is subject to the provisions relating to imposition of interest, penalty and handling charges set forth in TSCA, 15 U.S.C. § 2615(a)(4), and the Federal Claims Collection Act of 1966, 31 U.S.C. § 3717. Interest will accrue on the default penalty at the rate established by the Secretary of the Treasury pursuant to 31 U.S.C. § 3717. A late payment handling charge of twenty ($20.00) dollars will be imposed after thirty (30) days, with an additional charge of ten ($10.00) dollars for each subsequent 30-day period over which an unpaid balance remains. In addition, a six (6%) percent per annum penalty will be applied on any principal amount not paid within ninety (90) days of the date that the Default Order is signed by the Regional Administrator. ------- —8— Iv SETTLD(ENT CONFERENCE Whether or not you request a hearing, an informal conference may be requested in order to discuss the facts of this case and to arrive at a settlement. To request a settlement conference,• please write to Ms. Abeer Hashem, Environmental Scientist, Pesticides & Toxic Substances Branch (5SPT-7), United States Environmental Protection Agency, Region V, 230 South Dearborn Street, Chicago, Illinois 60604, or telephone her at (312) 886— 1331. Please note that a request for an informal settlement conference does not extend the twenty (20)-day period during which a written Answer and Request for Hearing must be submitted. The informal conference procedure, however, may be pursued simultaneously with the adjudicatory hearing procedure. U.S. EPA encourages all parties against whom a civil penalty is proposed to pursue the possibilities of settlement as a result of an informal conference. However, no penalty reduction will be made simply because such a conference is held. Any settlement which may be reached as a result of such conference shall be embodied in a written Consent Agreement and Final Order issued by the Regional Administrator, U.S. EPA, Region V. The issuance of such Consent Agreement shall constitute a waiver of your right to request a hearing on any matter stipulated to therein. If you have neither effected a settlement by informal conference nor requested a hearing within the 20-day time period ------- —9— allowed by this Notice, the above penalties will become due and payable upon the Regional Administrator finding you in default and issuing an Order for payment of penalties not in excess of those proposed herein. Refusal to remit such penalty will result in the referral of this matter to the United States Attorney for collection. 7f Uh 9. William H. Sanders III, P.E. Director, Environmental Sciences Division U.S. Environmental Protection Agency Region V Chicago, Illinois 60604 Dated: ____________ ------- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ) Docket No. TSCA—88-H-06 In the Matter of ) COMPLAINT AND NOTICE OF ) OPPORTUNITY FOR HEARING 3M COMPANY ) UNDER SECTION 16(a) OF (Minnesota Mininq and Manufacturing) ) THE TOXIC SUBSTANCES ) CONTROL ACT Respondent, ) _________________________________________________________________________________________ ) COMPLA IN ? This is a civil administrative action issued under the authority of Section 16(a) of the Toxic Substances Control Act, 15 U.S.C. 2601 et sea . (hereinafter “TSCA”). The Complainant is Connie A. Musarove, Chief Executive Officer, Office of Compliance Monitoring, Office of Pesticides and Toxic Substances United States Environmental Protection Agency (EPA), who has been duly delegated the authority to institute this action. The Resoondent is the Minnesota Mining and Manufacturing (3M) Company, P.O. Box 33331, St 1 Paul, Minnesota 55133. This Complaint serves as notice that Complainant has reason. to believe that Respondent manufactured (imported) and used for commercial purposes chemical substances in violation of Section 5 of TSCA, 15 U.S.C. Section 2604, Section 15 of TSCA, 15 U.S.C. Section 2614, and Section 13 of TSCA, 1 .5 U.S.C. Section 2612, as follows: ------- —2— COUNT I 1. On (CBI deleted), Respondent provided EPA with records revealing that Respondent manufactured (imported) the new chemical substance, (CBI deleted), hereinafter designated as Chemical A. 2. An examination of Respondent’s submitted information revealed that beginning on (CBI deleted), and continuing to (CBI deleted), Respondent imported Chemical A on (CBI deleted) different days. The total importation during this period was (CBI deleted). 3. During the period between (CBI deleted), and (CBI deleted), the chemical substance, Chemical A, did not appear on the list of chemical substances maintained by the Administrator pursuant to 15 U.S.C. 2637. 4. Information provided to EPA by the Respondent revealed that the chemical substance mentioned in Paragraph 1 was manu- factured (imported) for use in the United States. ------- —3— 5. Pespondent failed to submit a notice to the Administrator of EPA of its intention to manufacture (import) the new chemical substance, Chemical A. 6. Section 5(a)(l) of TSCA, 15 U.S.C. 2604(a)(l), provides that no person may manufacture (Import) a chemical substance which does not appear on the TSCA chemical substance inventory with- out submitting a notice to the Administrator of EPA at least 9 ’) days before manufacturing (importing) such substance. Section 15(l)(B) of TSCA, 15 U.S.C. 2614(1)(B), provides that it is unlawful for any person to fail to comply with any re— quirer ent prescribed by Section 5. Section 15(3)(B) of TECA, 15 U.S.C. 2614(3)(B), provides that it is unlawful for any person to fail to submit information required by the Act. 7. The conduct described in paragraphs 2 through S above was in violation of Section 5(a)(1), 15(1)(B), and 15(3)(B) of TSCA in that Respondent failed to submit a notice to the Adminis— trator of EPA at least 90 days before manufacture (Import) of the chemical substance as required. a ------- —4— COUNT II 8. Paragraph 1 of Count I is incorporated and realleged, as if fully set forth herein. 9. An examination of Respondent’s submitted information revealed that beginning on (CBI deleted), and continuing to (CBI deleted), Respondent imported Chemical A on (CBI deleted) different days and furnished a written statement to the U.S. Customs Service certifying that Chemical A was not being offered for entry in violation of TSCA. 1). Respondent failed to submit a notice to the Administrator of EPA of its intention to manufacture (import) a new chemical substance as required by Section 5(a) of TSCA. 11. Respondent failed to submit a certification to the district director at the port of entry representing the true compliance status of Chemical A. ------- —5— 12. Section 5(a)(l) of TSCA, 15 U.S.C. 2604(a)(1), provides that no person may manufacture (import) a chemical substance which does not appear on the TSCA chemical substance inventory with- out submitting a notice to the Administratqr of EPA at least 90 days before manufacturing (importing) such substance. Section 13(b) of TSCA, 15 U.S.C. 2612(b) requires the Secretary of the Treasury to issue rules for the administration of Section 13(a) which provides for the entry of chemical substances into the customs territory of the United States. The Customs rule at 19 CFR Part 12, SS12.118 through 12.127, issued under S13(b) provides that the importer of a chemical substance shall certify to the district director at the port of entry that the chemical substance being offered for entry is not in violation of TSCA or any applicable rule thereunder. Section 15(3)(B) of TSCA, 15 U.S.C. 2614(3)(B), provides that it is unlawful to fail to submit information as required by this Act or rule therunder. 13. The conduct described in Paragraghs 9 through 11 above was in violation of Section 5(a)(1), Section 13(b), and Section 15(3)(B) of TSCA, in that Respondent failed to submit a certification to the district director at the port of entry adequately re— presenting the compliance status of Chemical A, as required. ------- —6— COUVT III 14. On (CBI deleted), Respondent provided EPA with records re- vealing that Respondent manufactured (imported) the new chemical substance, (CBI deleted), hereinaher designated as Chemical B. 15. An examination of Respondent’s submitted information revealed that beginning on (CBI deleted) and continuing to (CBI deleted) Respondent imported Chemical B on (CBI deleted) different days. The total importation during this period was (CBI deleted). 16. During the period between (CE! deleted) and (CBI deleted), the chemical substance, Chemical B, did not appear on the list of chemical substances maintained by the Administrator pursuant to 15 U.S.C. 2607. 17. Information provided to EPA by the Respondent revealed that the chemical substance mentioned in Paragraph 14 was manufactured (imported) for use in the United States. ------- —7— 1 . Pespondent failed to submit a notice to the Administrator of EPA of its lntention to manufacture (import) the new chemical substance, Chemical B. 19. Section 5(a)(l) of TSCA, 15 U.S.C. 2604(a)(l), provides that no person may manufacture (import) a chemical substance which does not appear on the TSCA chemical substance inventory with- out submitting a notice to the Administrator of EPA at least 90 days before manufacturing (importing) such substance. Section 15(l)(B) of TSCA, 15 U.S.C. 2614(1)(B), provide. that it is unlawful for any person to fail to comply with any re- quirement prescribed by Section 5. Section 15(3)(B) of TSCA, 15 u.S.C. 2614(3)(B), provides that it is unlawful for any person to fail to submit information required by the Act. 20. The conduct described In paragraphs 15 through 18 above was in violation of Section S(a)(l), 15(1)(B.), and 15(3)(B) of TSCA in that Respondent failed to submit a notice to the Administrator of EPA at least 90 days before manufacture (import) of the chemical substance as required. ------- —8— COUNT I V 21. Paragraph 14 of Count III is Incorporated and realleged, as if fully set forth herein. 22. An examination of Respondent’s submitted information revealed that beginning on (CBI deleted) and continuing to (CBI deleted) Respondent imported Chemical B on (CBI deleted) different days and furnished a.written statement to the U.S. Customs Service certifying that Chemical B was not being offered for entry in violation of TSCA. 23. Pespondent failed to subrnit a notice to the Administrator of EPA of its intention to manufacture (Import) a new chemical substance as required by Section 5(a of TSCA. 24. Respondent failed to submit a certification to the district director at the port of entry representing the true compliance status of Chemical B. ------- —9— 25. Section 5(a)(l) of TSCA, 15 U.S.C. 2604(a)(l), provides that no person may manufacture (import) a chemical substance which does not appear on the TSCA chemical substance inventory with- out submitting a notice to the Administrator of EPA at least 90 days before manufacturing (importing) such substance. Section 13(b) of TSCA, 15 U.S.C. 2612(b) requires the Secretary of the Treasury to issue rules for the administration of Section 13(a) which provides for the entry of chemical substances into the customs territory of the United States. The Customs rule at 19 CFR Part 12, SS12.l18 through 12.127, issued under S13(b) provides that the importer of a chemical substance shall certify to the district director at the port of entry that the chemical substance being offered for entry is not in violation of TSCA or any applicable rule thereunder. Section 15(3)(B) of TSCA, 15 U.S.C. 2614(3)(B), provides that It is unlawful to fail to submit information as required by this Act or rule therunder. 26. The conduct described in Paragraghs 22 through 24 above was in violation of Section 5(a)(l), Section 13(b), and Section 15(3)(B) of TSCA, in that Respondent failed to submit a certification to the district director at the port of entry adequately re- presenting the compliance status of Chemical B, as required. ------- — 10 — PPOPOEED CIVIL PEMALTY Section 16 of TSCA, 15 U.S.C. Section 2615, authorizes the assessment of a civil penalty of up to $25,000 per day for each violation of TSCA. Based upon the facts alleged in this Complaint, and upon the nature, circumstances, extent and gravity of the violations alleged, as well as Respondent’s history of prior violations of TSCA, the degree of culpability and such other matters as justice may require, the Complainant proposes that Respondent be assessed the following civil penalty for the violations alleged in this Complaint: COUNT I Failure to notify of intention to manufacture (import) a chemical substancenoton theTSCAinventory......................$l,609,000 15 U.S.C. 2634(a)(1) 15 U.S.C. 2614(l)(B) 15 U.S.C. 26l4(3)(B) COUNT II Failure to provide a certification statement to the district director at the port of entry adequately representing the compliance status of a chemical substance..................................$ 720,000 15 U.S.C. 2604(a)(1) 15 U.S.C. 2612(b) 15 U.S.C. 2614(3)(B) ------- — 11 — COUNT III Failure to notify of intention to manufacture (import) a chemical substance not on the TSCA inventory...................$ 260,000 15 U.S.C. 2604(a)(l) 15 U.S.C. 2614(l)(B) 15 U.S.C. 2614(3)(B) COUNT IV Failure to provide a certification statement to the district director at the port of entry adequately representing the compliance status ofa chemicalsubstance.................,.............$ 200,000 15 U.S.C. 2634(a)(1) 15 U.S.C. 2612(b) 15 U.S.C. 2614(3)(B) TOTAL................................. $ 2,789,0’30 Adjustments to Proposed Penalty Because Respondent voluntarily disclosed to EPA the violations alleged in this Complaint, Complainant is adjusting the proposed penalty downward twenty—five percent. Complainant is adjusting the proposed penalty an additional twenty—five percent because Respondent contacted EPA immediately upon discovering activities in violation of TSCA. ADJUSTED TOTAL PROPOSED CIVIL PENALTY ............... $ 1,394,500 ------- — 12 — NOTICE OF OPPORTUNITY TO REOUEST A HEARING As provided in Section 16(a)(2)(A) of TSCA, and in accordance with 554 of Title 5, United States Code, you have the right to request a formal hearing to contest any material fact set forth in this Complaint or to contest the appropriate- ness of the proposed penalty. To avoid being found in default and having the above—cited penalty assessed without further proceedings, you must file a written Answer within twenty (20) days of your receipt of this Complaint. Your Answer should (1) clearly and directly admit, deny, or explain each of the factual allegations contained in this Complaint, (2) briefly state all facts and circumstances, if any, which constitute grounds for a defense, and (3) specifically request an ajministrative hearing (if desired). The denial of any material fact or the raising of any affirmative defense shall be construed as a request for hearing. Failure to deny any of the factual allegations in this Complaint will constitute an admission of the undenied allegations. The Answer should be sent to: Headquarters Hearing Clerk (A—hO) United States Environmental Protection Agency 401 P1 Street, S.W., Room 3706 Washington, DC 20463 ------- — 13 — The hearing which will be held upon your request will be conducted in accordance with the Administrative Procedure Act (5 U.S.C. Section 551 et seq.) and the Consolldated Rules of Practice Governing the Administrative Assessment of Civil Penalties and the Revocation or Suspension of Permitsu 40 CFR Part 22 (45 FR 24360). A copy of the Consolidated Rules accompanies this Complaint. INFO 4AL SETTLEMENT CONFERENCE Whether or not you request a hearing, you may confer informally with EPA to discuss the facts of this case, or amount of the proposed penalty, and the possibility of settlement. An informal settlement conference does not, however, affect your obligation to file a written Answer to the Complaint. EPA has the authority to modify the amount of the proposed penalty, where appropriate, to reflect any settlement reached with you in an informal conference. The terms of such an agreement would be embodied in a Consent Agreement and Final Order. A Consent Agreement signed by EPA and yourself would be binding as to all terms and conditions specified therein. ------- — 14 — Any requests for an informal conference, copies of all documents to be filed by Respondent, including the Answer, and any other questions that you may have regarding this Complaint should be directed to: Mr. Bob Pittman, Attorney Toxics Litigation Division (LE—134—P) U.S. Environmental Protection Agency 431 M Street, S.W. Washington, D.C. 20460 (202) 475—8690 PAYMENT OF PENALTY Instead of filing an Answer requesting a hearing or requesting an informal settlement conference, you may choose to pay the pro- posed penalty. Such payment should be made by sending to the Headquarters Hearing Clerk’s address listed below a cashier’s or certified check in the amount of the penalty assessed in this Complaint. Your check must be made payable to the United States of America and sent to: EPA—Washington (Hearing Clerk) P.O. Box 360277M Pittburgh, PA 15251 ------- — 15 — UNITED STATES ENVIRONMENTAL PROTECTION AGENCY Complainant BY: \ Connie A. Musgrove Chief Executive Officer Office of Compliance Monitoring SEP 2I98 Date: ------- — 16 — CERTIFICATION I hereby certify that the original of the foregoing complaint and Notice of Opportunity for Hearing, Docket No TSCA-88-H-06, has been filed with the Headauarters Hearing Clerk and that copies were sent, registered mail, return receipt requested to: Mr. Uan Jacobson, Chairman Minnesota Mining and Manufacturing (3M Comoany) P .O. Box 33331 St. Paul, MN 55133 __ _______ ‘t Za )ate John Mason (EN—342) Document Control Officer U.S. Ei vironmental Protection Agency 401 M Street, S.W. Washinaton, D.C. 20460 ------- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ______________________________ Docket No. TSCA 89—H—21 ) COMPLAINT AND NOTICE OF In the Matter of ) OPPORTUNITY FOR HEARING Monsanto Company ) UNDER SECTION 16(a) OF ) THE TOXIC SUBS CES Respondent ) CONTROL ACT _________________ ) c This is a civil administrative action issued under the authority of Section 16(a) of the Toxic Substances Contro ”Act, 15 U.S.C. 2601 et (hereinafter “TSCA”). The Complainant is Michael F. Wood, Director, Compliance Division, Office of Compliance Monitoring, United States Environmental Proteàtion Agency (EPA), who has been duly delegated the authority to institute this action. The Respondent is Monsanto Company, St. Louis, Missouri, a manufacturer, processor and distributor of chemical substances and mixtures in commerce. This Complaint serves as notice that Complainant has reason to believe that Respondent failed to immediately submit information as required by Section 8 of TSCA, 15, U.s. c. Section 2607, and Section 15 of TSCA, 15 U.S.C. Section 2614, as follows: ------- —2— 1. The Respondent is a manufacturer, processor and distributor of the chemical substance, Santogard PVI (Chemical Abstract Services Registry No. 17796—82—6; also known as test substance CP 29242), a pre—vulcanization inhibitor used in the production of natural and synthetic rubber products. 2. On or about Septernoer 28, 1978, a “CP29242: Two—year Chronic Toxicity and Carcinogenicity Study in the Rat” (hereinafter referred t as the “study”) was initiated for the Respondent at Pharmecopathics Research Laboratories, Inc. (currently Tegeris Laboratories. Inc.), Laurel, Maryland. The in—life portion of this study terminated on or aoout October 21, 19a0. 3. On or aoout October 15. 1981, Respondent obtained a copy of the reported results from tne study. Page 68 of the October 15, 1981 rej ort states that Santogard PVI “...when fed to the rats under the conditions of this experiment, causes a dose—related effect in body weight and hepatic histopathology.” The report also states that “histopathologically the only tumor findings that appear pertinent (compound related) . . . are limited to the liver In the dead and moribund animals there were . 3/33 adenomata ((i.e., adenomas)Jiri the female mid—dose group. 5/34 adenomata in the female high—dose group and 1/33 hepatocellular carcinoma in the female mid-dose group; in ------- —3— the surviving animals there were . . . 1/37 adenomata in the female mid—dose group and 6/41 adenomata in the female high— dose group.” 4. In regard to item 3. above,, combining the incidence of hepatocellular adenomas in the females found dead and sacrificed moribund with those in the surviving group animals, the number of females with hepatocellular adenomas n the mid-dose group is 4 of 70 or 5.7% whereas in the high—dose group it is 11 of 75 or 14.7%. 5. The October 15, 1981 report results indicate a dose—related incidence in the number of female rats with benign liver twnors (hepatoceliular adenornas). 6. On or about March 6. 1984, Respondent obtained a copy of a report at d March 1. l9 4, concerning tne sar e study. Page 72 of this report states “Combining the incidence of adenomas in the females designed as ‘dead and sacrificed rnori und’ with tnose in the ‘surviving group’ animals, the number of animals with adenomas in the mid—dose group was now 4 of 70 or 5.7% whereas in the high—dose group it was 11 of 75 or 14.7%. These results suggest an association between test chemical [ (C?29242)J and the observation of benign hepatic adenomas in treated females.” 7. The March 1, 1984 report results indicate a dose— related incidence in the number of female rats with benign liver tumors (hepatocellular adenomas). ------- —4— 8. SectiOn 8(e) of TSCA, 15 U.S.C. Section 2607(e), provides that “Any person who manufactures, processes, or distrioutes in commerce a chemical substance or m xture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment shall immediately inform the Administrator of such information unless such person has actual knowledge that the Administrator has been adequately informed of such information.” 9. In a July 1, 1986 letter addressed to Mr. Edwin F. Tinsworth, Acting Director of the Office of Toxic Substances, Respondent informed tne EPA on a “for your informatior.” basis of tne results of the study. Respondent’s letter included a copy of the Abstract section and several tables from the March 1, 1984 report. 10. EPA received the Respondent’s July 1, 1986 “for your information” letter and enclosures on or about July 3, 1986. 11. The EPA “Statement of Interpretation and Enforcec ent Policy; Notification of Substantial Risk” under TSCA Section 8(e) published in the Federal Register (43 FR 11110, March 16, 1978), hereinafter referred to as “the Section 8(e) policy statement” sets forth EPA’S interpretation of and policy concerning the provisions of TSCA Section 8(e). 12. Respondent is a “person” as defined in Part I of the Section 8(e) policy statement (43 FR 11111), and has been a ma iufacturer of Santogard PVI since 1976. ------- —5— 13. The Section 8(e) policy statement provides that a person has “immediately informed” EPA if the information is received bj EPA within 15 working days of the person’s receipt of such information. 14. Tne Section 8(e) policy statement provides that information must be reported in accordance with Part IX (“Reporting Rep.iirernents”) of the policy statement. 15. The findings concerning the dose-related incidence of benign liver tumors obtained by the Respondent in the October 15, 1981 report arid/or the March 1, 1984 report reasonably support the conclusion that the chemical substance, Santogard PVI, presents a substantial risk of injury to health or the environr 1ent, and are not corroborative of well established adverse effects already documented in the scientific literature or about which the Administrator was adequately informed. 16. Respondent failed to immediately inform the Administrator about the dose-related incidence of benign liver tumors at’iong the female rats in the Respondent’s “CP29242: Two—year Chronic Toxicity and Carcinogenicity Study in the Rat.” 17. Section 15(3)(8) of TSCA provides that it is unlawful for anyone to fail to submit information required by TSCA. ------- —6— PROPOSED CIVIL. PENALTY Section 16 of TSCA, 15 U.S.C. Section 2615, autnorizes the assessment of a civil penalty of up to $25,000 per day for each violation of TSCA. Based upon the facts alleged in this Complaint, and upon the nature, circumstance, extent and gravity of the violations alleged, as well as Respondent’s history of prior violations of TSCA, the degree of culpability and sucn other matters as justice may require, the Complainant proposes that Respondent be assessed a civil penalty of $253,200 for the violation alleged in this Complaint. NOTICE OF OPPORTUNITY TO RE.QUEST A hE..R RING As provided in Section 16(a) (2) (A) of TSCA, and in accordance with 554 of Title 5, United States Code, you have the right to request a formal hearing to contest any material fact set forth in this Complaint or to contest the appropriateness of the proposed penalty. To avoid being found in default and having tne above-cited penalty assessed without further proceedings, you must file a written Answer within twenty (20) days of your receipt of this Complaint. Your Answer should (1) clearly and directly admit, deny, or expiain each of the factual allegations contained in this Complaint, (2) briefly state all facts and ------- —7— circumstances, if any, which constitute grounds for a defense, and (3) specifically request an administrative hearing (if d?sired). The denial of any material fact or the raising of any affirmat’ve defense shall be construed as a request for a hearing. Failure to deny any of the factual allegations in this Cor piaint will constitute an admission of the undenied allegations. The Answer should be sent to: Headquarters Hearing Clerk (A—hO) United States Environmental Protection Agency 401 M Street, S.W., Room 3706 Washington, DC 2O46 Tne hearing which will be held upon your request will be conductei in accordance with the Administrative Procedure Act (5 U.S.C. Se:tiou 551 et seq. ) and the “Consolidated Rules of Pract. ce Governing the Administrative Assessment of Civil Penalties and the Revocation or Suspensior of Permits” 40 CFR Pa:t 22 (45 FR 24.6 ). A copy of the Consolidated Rules accor panies this Complaint. INFORMAL. SETTLEMENT CONFERENCE Wnether or not you request a hearing, you may confer informa. ly with EPA to discuss the facts of this case, or am3unt of the proposed penalty, and the possibility of settlement. An informal settlement conference does not, however, affect your obligation to file a written Answer to the Complaint. ------- —8— EPA has the authority to modify the amount of the proposed penalty, where appropriate, to reflect any settlement reached with you in au informal conference. The terms of such an agreement would be embodied in a Consent Agreement and Final Order. A Cocusent Agreement signed by EPA and yourself would be oiriding as to all terms and conditions specified therein. Any requests for an informal conference, copies of all docu.1 ent.3 to be filed by Respondent, including the Answer, and any other questions that you may have regarding this Complaint si ould oe directed to: Mr. Vincent Giordano, Attorney Toxics itigation Division (LE—134—P; U.S. Environmental Protection Agency 401 M Street, S. . Washington, DC 20460 (202) —475—8693 PAYMENT OF PENAEdTY Instead of filing an Answer requesting a hearing or requesting an informal settlement conference, you may choose to pay the proposed penalty. Such payment should be made by sending to the Headquarters Hearing Clerk’s address listed below a cashier’s or certified check in the amount of the penalty assessed in this Complaint. Your check mast be made payable to the United States of America and sent to: EPA—Washington (Hearing Clerk) P.O. Box 360277M Pittsburgh, PA 15251 ------- —9— UNITED STATES ENVIRONMENTAL PROTECTION AGENCY TSCA 89—H—21. Complainant BY: Michael f. Wooa, Directo Compliance Division Office of Cor pliance Monitoring Date: ------- — 10 — CERTIFICATION I hereby certify that the original of the foregoing Complaint and Notice of Opportunity for Hearing, Docket No. TSCA—89—H—21 , has been filed with the Headquarters Hearing Clerk and that copies were sent, registered mail, return receipt requested to: Mr. James H. Senger Vice President Monsanto Company 800 N. Lindbergh Boulevard St. Louis, Missouri 63167 j ’D e AcA-p7 D te / ose Burgess (EN-342) Case Preparation Officer U.S. Environmental Protection Agency 4C1 M Street, S.W. Washington, D.C. 20460 ------- ‘ • C ,.. UNITED kTES FM1I OUMENTAL PROTECTION AGENCY ) In the Matter of ) ) 3M comoany ) Docket No. TSCA 88-H—06 (Minnesota Mining and Manufacturina) ) ) Pespondent, ). ____________________________________________________________________________________________ ) Notice of Treatment of Confidential Business Information Portions o the attached Comolaint reouire use of information which Resoondent submitted to the United States Environmental - Protection aency (EPa) as Confidential Business Information (CBI). Information in the Complaint constituting or based on C3I has been deleted as Indicated by the follouin’,: (CBI deleted). The original complaint containing CBI is filed with the Headquarters Hearina Clerk. It will itself be treated as confidential unless Pesoondent waives confidentiality thereto or EPA releases the information in accordance with 40 C.F.R. part 2. S ------- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY In the Matter of ALCOLAC INCORPORATED ) Docket No. TSCA 89—H— 22 Respondent __________________________________________________________________________________ ) Notice of Treatement of Confidential Business Information Portions of the attached Complaint require use of information which Respondent submitted to the United States Environmental Protection Agency (EPA) as Confidential Business Information (CEl). Information in the Complaint constituting or based on CBI has been deleted as indicated by the following: (CEl deleted). The original Complaint containing CBI is filed with tne headquarters Hearing Clerk. It will itself be treated as confidential unless and until Respondent waives confidentiality thereto or EPA releases the information in accordance with 40 CER Part 2. ------- —2— 1. On August 1, 1984, May 20—21, 1986, and June 12, 1987, inspections were conducted, by duly designated representatives of the EPA, at Respondent’s facilities located at 3440 Fairfield Road, Baltimore, Maryland and at Randall Road, Sedalia, Missouri, respectively. 2. These inspections were conducted to determine Respondent’s compliance with TSCA requirements. COUNT I 3. Paragraphs 1 — 2 are hereby incorporated and realleged as if fully set forth herein. 4. Respondent is a “person” as defined in 40 CFR Section 720.3(x) and as such is subject to TSCA and the regulations promulgated thereunder. 5. Respondent’s records revealed that Respondent manufactured for commercial purposes the chemical substances as described in Counts I—IV, respectively. 6. On these occasions, the chemicals identified in Counts i-i ll of this Complaint, did not appear on the TSCA Inventory of Existing Chemical Substances (“TSCA Inventory”) maintained by the Administrator pursuant to 15 U.S.C. Section 2607. ------- —4— COUNT II 12. Paragraphs 3 — 6 are hereby incorporated and realleged as if fully set forth herein. 13. Records revealed that Respondent manufactured a new chemical substance, (CBI deleted), CAS # (CBI deleted), and identified by product code name (CBI deleted), hereinafter designated as Chemical B. 14. Paragraphs 8 — 9 are hereby incorporated and realleged as if fully set forth herein. 15. Respondent’s records revealed that from March 1982 through December 1986, Respondent had manufactured (CBI deleted) pounds of Chemical B for TSCA commercial purposes. During this time period, Respondent manufactured Chemical B on at least (CBI deleted) separate occasions. 16. Respondent failed to notify EPA of its intention to manufacture the new chemical substance, Chemical B, at least ninety (90) days before manufacturing Chemical B, thereby violating TSCA Sections 5(a) (1) (A), 15(1) (B), and 15(3) (B). COUNT III 17. Paragrapfls 3 — 6 are hereby incorporated and realleged as if fully set forth herein. ------- —6— CAS * Chemical Production Amt (CBI deleted) Chemical D (CBI deleted) (CBI deleted) Chemical E (CBI deleted) 24. According to 40 CFR Section 712.20(a), a person who manufacture in bulk form one or more of the chemical substances listed in 40 CFR Section 712.30 for commercial purposes must submit a Preliminary Assessment Information Report, (hereinafter referred to as a PAIR), to the Administrator of EPA, as required under Section 8(a) of TSCA. 25. Respondent is a “person” as defined in 40 CFR Section 712.3(6). 26. Section 8(a)(1) of TSCA authorized the Administrator of EPA to issue rules that requires reporting by manufacturers, importers and processors of chemical substances. The PAIR rules were promulgated on June 2, 1982 under 40 CFR Part 712, Subpart B entitled, Manufacturers Reporting—— Preliminary Assessment Information. Section 15(3) (B) of TSCA, 15 U.S.C. 2614(3) (B) provides that it is unlawful for any person to fail or refuse to submit reports as required under TSCA. 27. According to 40 CFR Section 712.30(a), Respondent was required to submit a PAIR for Chemicals D and E covering their 1981 calendar year production on or before November 19, 1982. ------- —8— 35. Pursuant to Section 8(a) of the Act, 15 U.S.C. Section 2607(a), EPA promulgated the “Inventory Reporting Regulations”, codified at 40 CFR Part 710. 40 CFR Part 710 establishes regulations governing reporting certain sub- stances for commercial purposes under Section 8(a) of the Act. 36. Pursuant to 40 CFR Sections 710.3 and 710.4, all persons wno manufactured and/or imported a chemical substance for a commercial purpose during 1977 were required to submit specific information to EPA concerning that chemical substance for inclusion in EPA’s initial TSCA inventory of chemical substances manufactured for commercial purposes under the Act, and only persons who manufactured or imported a chemical subtance for commercial purposes from January 1, 1975 to July 1, 1979 were permitted to report to EPA concerning that chemical substance for EPA’S TSCA Inventory of Chemical Substances. 37. Supplemental information submitted by the Respondent subsequent to the inspections, revealed that chemical substances F, G, and H cited in paragraphs 33 and 34 of this Complaint had not been manufactured by Respondent for commercial purposes at any time since January 1, 1975. Respondent therefore was not permitted to report these chemical substances for EPA’S TSCA Inventory of Chemical Substances. ------- —10— COUNTS I — III Failure to notify of intention to manufacture a new chemical substance: 15 U.S.C. 2604 (a)(1) 15 U.S.C. 2614 (1)(B) 15 u.s.c. 2614 (3) (B) $ 273.000 $ 16,500 $ 145.000 COUNT . $ 434,50a COUNT IV Failure to submit PAIR reports as rec uired: 15 U.S.C. 2607 (a)(1) 15 U.S.C. 2614 (3) (B) COUNT . .. . $ 68 378 COUNT V False reporting of chemical substances as manufactured for commercial purposes. Respondent is sole submitter of each chemical to EPA TSCA Inventory: - 15 U.S.C. 2607 (a)(] .) 15 U.S.C. 2614 (3)(B) COUNT .......•.................... $ 51.000 TOTAL PROPOSED CIVIL PENALTY .......... .. .... $ 553,878 ------- —12— Ti’e Answer shall also state the circumstances and arguments, if any, which are alleged to constitute the grounds of defense, and shall specifically request an administrative hearing, if desired. If you deny any material fact or raise any affirmative defense, you will be considered to have requested a hearing. The Answer must be filed with: Headquarters Hearing Clerk (A—hO) United States Environmental Protection Agency 401 M Street, S.W., Room M3706 Washington, DC 20460 Please send a copy of the Answer an all other documents which you file in this action to Vincent Giordano, the attorney assigned to represent EPA in this matter, at: Toxics Litigation Division (LE—134P) Office of Enfoccenent and Compliance Monitoring U.S. Environmental Protection Agency 401 M Street, S.W., Rm. NE hl3A asnington, D.C. 20460 INFORMAL SETTLEMENT CONFERENCE Whether or not you request a hearing, you may confer informally with EPA through Mr. Giordano regarding the facts of this case, or amount of the proposed penalty, and the possibility of settlement. An informal settlement conference does not, nowever, affect your obligation to file a written Answer to the Complaint. ------- —14— UNITED STATES ENVIRONMENTAL PROTECTION AGENCY TSCA 8 9—H- 22 Complainant BY: c. s2 Michael F. Wood, Director Compliance Division Office of Compliance Monitoring Date: ------- UNITED STATES ENVIRONMENTAEa PROTECTION AGENCY In the Matter of ALCOLAC INCORPORATED ) Docket No. TSCA 89—H- 22 Respondent ) Notice of Treatement of Confidential Business Information Portions of the attached Complaint require use of information which Respondent submitted to the United States Environmental Protection Agency (EPA) as Confidential Business Information (CBI). Information in the Complaint constituting or based on CBI has been deleted as indicated by the following: (CBI deleted). The original Complaint containing CBI is filed with the headquarters Hearing Clerk. It will itself be treated as confidential unless and until Respondent waives confidentiality thereto or EPA releases the information in accordance with 40 CFR Part 2. ------- UNITED STATES ENVIRONMENTAL. PROTECTION AGENCY ______________________________ Docket No. TSCA 89—H—22 COMPLAINT AND NOTICE OF In the Matter of ) OPPORTUNITY FOR HEARING ALCOLAC INCORPORATED ) UNDER SECTION 16(a) OF THE TOXIC SUBSTANCES Respondent ) CONTROL ACT This is a civil administrative action issued under the authority of Section 16(a) of the Toxic Substances Control Act, 15 U.S.C. 2601 et se • (hereinafter “TSCA”). The Complainant is Michael F. Wood, Director, Compliance Division, Office of Compliance Monitoring, United States Environmental Protection Agency (EPA), who has been duly delegated the authority to institute this action. The Respondent is Alcolac Incorporated, Baltimore, Maryland. This Complaint serves as notice that Complainant has reason to believe that Respondent manufactured chemical substances in violation of Sections 5, 8 and 15 of TSCA, 15, U.S.C. Section 2614, as follows: ------- —2— 1. On August 1, 1984, May 20—21, 1986, and June 12, 1987, inspections were conducted, by duly designated representatives of the EPA, at Respondent’s facilities located at 3440 Fairfield Road, Baltimore, Maryland and at Randall Road, Sedalia, Missouri, respectively. 2. These inspections were conducted to determine Respondent’s compliance with TSCA requirements. COUNT I 3. Paragraphs 1 — 2 are hereby incorporated and realleged as if fully set forth herein. 4. Respondent is a “person” as defined in 40 CFR Section 720.3(x) and as such is subject to TSCA and the regulations promulgated thereunder. 5. Respondent’s records revealed that Respondent manufactured for commercial purposes the chemical. substances as described in Counts I—IV, respectively. 6. On these occasions, the chemicals identified in Counts I—Ill of this Complaint, did not appear on the TSCA Inventory of Existing Chemical Substances (“TSCA Inventory”) maintained by the Administrator pursuant to 15 U.S.C. Section 2607. ------- —3— 7. Records revealed that Respondent manufactured a new chemical substance, (CBI deleted), chemical abstract number (CBI deleted), and identified by product code name (CBI deleted), hereinafter designated as Chemical A. 8. Section 5(a)(l) of TSCA, 15 U.S.C. 2604(a) (1), provides that no person may manufacture a chemical substance which does not appear on the TSCA chemical substance inventory without first submitting a Premanufacture Notification to the Administrator of EPA at least 90 days before manufacturing such substance. 9. Section 15(1) (B) of TSCA, 15 U.S.C. 2614(1) (B) , provides that it is unlawful for any person to fail or refuse to comply with any requirement prescribed by Section 5. Section 15(3)(B) of TSCA, 15 U.S.C. 2614(3) (B) provides that it is unlawful for any person to fail or refuse to submit reports, notices, or other information as required by TSCA. 10. Respondent’s records revealed that between October 1979 and June 1986, Respondent manufactured (CBI deleted) pounds of Chemical A for TSCA commercial purposes. During this time period, Respondent manufactured Chemical A on at least (CBI deleted) separate occasions. 11. Respondent failed to notify EPA of its intention to manufacture the new chemical substance, Chemical A, at least ninety (90) days before manufacturing Chemical A, thereby violating TSCA Sections 5(a) (1) (A), 15(1) (B), and 15(3) (B). ------- —4— COUNT II 12. Paragraphs 3 — 6 are hereby incorporated and realleged as if fully set forth herein. 13. Records revealed that Respondent manufactured a new chemical substance, (CM deleted), CAS • (CBI deleted), and identified by product code name (CBI deleted), hereinafter designated as Chemical B. 14. Paragraphs 8 — 9 are hereby incorporated and realleged as if fully set forth herein. 15. Respondent’s records revealed that from March 1982 through December 1986, Respondent had manufactured (CBI deleted) pounds of Chemical B for TSCA commercial purposes. During this time period, Respondent manufactured Chemical B on at least (CBI deleted) separate occasions. 16. Respondent failed to notify EPA of its intention to manufacture the new chemical substance, Chemical B, at least ninety (90) days before manufacturing Chemical B, thereby violating TSCA Sections 5(a) (1) (A), 15(1) (B), and 15(3) (B). COUNT III 17. Paragraphs 3 — 6 are hereby incorporated and realleged as if fully set forth herein. ------- —5— 18. Records revealed that Respondent manufactured a new chemical substance, (CBI deleted), CAS * (CBI deleted) and identified by product code name (C8I deleted), hereinafter designated as Chemical C. 19. Paragraphs 8 — 9 are hereby incorporated and real].eged as if fully set forth herein. 20. Respondent’s records revealed that from October 1983 through December 1985 Respondent had manufactured (CBI deleted) pounds of Chemical C for TSCA commercial purposes. During this time period, Respondent had manufactured Chemical C on (CBI deleted) separate occasions. 21. Respondent failed to notify EPA of its intention to manufacture the new chemical substance, Chemical C, at least ninety (90) days before manufacturing Chemical C, thereby violating TSCA Sections 5(a)(1)(A), 15(l)(B), and 15(3)(B). COUNT IV 22. Paragraphs 1 — 2 are hereby incorporated and realleged as if fully set forth herein. 23. Information collected during the inspections and subsequent information submitted by the Respondent revealed that Respondent manufactured for TSCA commercial purposes, as defined at 40 CER Part 712.3, the following chemical • substances listed as chemical abstract service registry numbers, (CAS *s) from January 1981 through December 1981: ------- —6— CAS * Chemical Production Amt (CBI deleted) Chemical D (CBI deleted) (CHI deleted) Chemical E (CBI deleted) 24. According to 40 CFR Section 712.20(a), a person who manufacture in bulk form one or more of the chemical substances listed in 40 CFR Section 712.30 for commercial purposes must submit a Preliminary Assessment Information Report, (hereinafter referred to as a PAIR), to the Administrator of EPA, as required under Section 8(a) of TSCA. 25. Respondent is a “person” as defined in 40 CFR Section 712.3(6). 26. Section 8(a)(1) of TSCA authorized the Administrator of EPA to issue rules that requires reporting by manufacturers, importers and processors of chemical substances. The PAIR rules were promulgated on June 2, 1982 under 40 CFR Part 712, Subpart B entitled, Manufacturers Reporting—- Preliminary Assessment Information. Section 15(3) (B) of TSCA, 15 U.S.C. 2614(3) (B) provides that it is unlawful for any person to fail or refuse to submit reports as required under TSCA. 27. According to 40 CFR Section 712.30(a), Respondent was required to submit a PAIR for Chemicals D and E covering their 1981 calendar year production on or before November 19, 1982. ------- —7— 28. As of the date of EPA’s August 1, 1984 inspection, Respondent had not submitted a PAIR for Chemicals D and E on or before the November 19, 1982 reporting date as required. 29. On or about August 1, 1984, Respondent submitted PAIRS for Chemicals D and E to the Agency pursuant to 40 CFR Section 712.30(a). 30. On or about November 7, 1986, two years after the August 1984 submissions, Respondent supplied the Agency with a revised PAIR for Chemical D. 31. As described in Paragraphs 28 and 30 above, Respondent violated Section 8(a) and 15(3)(B) of TSCA in that Respondent failed to submit a PAIR for Chemicals D andE to the Administrator of EPA for the reporting date as required. COUNT V 32. Paragraphs 1 — 2 are hereby incorporated and realleged as if fully set forth herein. 33. On or about June 18, 1978, the Respondent reported to EPA that the Respondent had manufactured chemical substances listed as CAS #s (CM deleted and CM deleted), hereinafter designated as Chemicals F and G, substances for TSCA commercial purposes since January 1, 1975. 34. On or about May 29, 1979, the Respondent reported to EPA that the Respondent had manufactured the chemical substance listed as CAS (CBI deleted), hereinafter designated as Chemical H, a substance for TSCA commercial purposes since January 1, 1975. ------- —8— 35. Pursuant to Section 8(a) of the Act, 15 U.S.C. Section 2607(a), EPA promulgated the “Inventory Reporting Regulations”, codified at 40 CFR Part 710. 40 CFR Part 710 establishes regulations governing reporting certain sub- stances for commercial purposes under Section 8(a) of the Act. 36. Pursuant to 40 CFR Sections 710.3 and 710.4, all persons wno manufactured and/or imported a chemical substance for a commercial purpose during 1977 were required to submit specific information to EPA concerning that chemical substance for inclusion in EPA’S initial TSCA inventory of chemical substances manufactured for commercial purposes under the Act, and only persons who manufactured or imported a chemical subtance for commercial purposes from January 1, 1975 to July 1, 1979 were permitted to report to EPA concerning that chemical substance for EPA’S TSCA Inventory of Chemical Substances. 37. Supplemental information submitted by the Respondent subsequent to the inspections, revealed that chemical substances F, C, and H cited in paragraphs 33 and 34 of this Complaint had not been manufactured by Respondent for commercial purposes at any time since January 1, 1975. Respondent therefore was not permitted to report these chemical substances for EPA’S TSCA Inventory of Chemical Substances. ------- —9— 38. Respondent was the sole submitter of each of the chemical substances F, G, and H cited in paragraph 33 and 34 of this Complaint for EPA’s TSCA Inventory of Chemical Substances. 39. Pursuant to Section 15(3) of the Act, 15 U.S.C. Section 2614(3), it is lawful for any person to fail or refuse to establish and maintain records or to submit the reports, notices or other information as required by the Act or a rule thereunder. 40. As described in Paragraphs 33, 34, and 37 above, Respondent violated Sections 8(a) and 15(3)(B) of the Act, 15 U.S.C. Sections 2607(a) and 2614(3) (B) by reporting chemical substances F, G, and H as chemicals manufactured by Respondent for commercial purposes. PROPOSED CIVIL PENALTY Section 16 of TSCA, 15 U.S.C. Section 2615, authorizes the assessment of a civil penalty of up to $25,000 per day for each violation of TSCA. Based upon the facts alleged in this Complaint, and upon the nature, circumstances, extent and gravity of the violations alleged, as well as Respondent’s history of prior violations of TSCA, the degree of culpability and such other matters as justice may require, the Complainant proposes that Respondent be assessed the following civil penalty for the violations alleged in this Complaint: ------- —10— COUNTS I — III Failure to notify of intention to manufacture a new chemical substance: 15 U.S.C. 2604 (a) (1) 15 U.S.C. 2614 (1) (B) 15 u.s.c. 2614 (3) (8) . . $ 273.000 $ 16,500 $ 145. 000 COUNT $ 434,500 COUNT IV Failure to submit PAIR reports as required: 15 U.S.C. 2607 (a)(1) 15 U.S.C. 2614 (3) (B) COUNT . . $ 68.378 COUNT V False reporting of chemical substances as manufactured for commercial purposes. Respondent is sole submitter of each chemical to EPA TSCA Inventory: 15 U.S.C. 2607 (a)(1) 15 U.S.C. 2614 (3) (B) COUNT . . . . . ........ . . . . . . . . . $ 51. 000 TOTAL PROPOSED CIVIL PENALTY ......... $ 553,878 ------- —11— NOTICE OF OPPORTUNITY TO REQUEST A HEARING As provided in Section 16(a) (2) (A) of TSCA, you have the right to request a formal hearing to contest any material fact set forth in this Complaint or to contest the appropriateness of the proposed penalty. Any hearing requested will be conducted in accordance with the Administrative Procedures Act, 5 U.S.C. Section 551 et seq. , and the Consolidated Rules of Practice Governing the Administrative Assessment of Civil Penalties , 40 CFR Part 22 ( “Consolidated Rules of Practice”) . A copy of the Consolidated Rules of Practice accompanies this Complaint. To avoid being found in default, which constitutes an admission of all facts alleged in the Co&nplaint and a waiver of the right to a hearing, and having the above penalty assessed without further proceedings, you must file a written Answer within twenty (20) days of receiving this Complaint . Pursuant to the Consolidated Rules of Practice, your Answer must clearly and directly admit, deny, and/or explain each of the factual allegations contained in this Complaint with regard to which you have any knowledge. If you have no knowledge of a particular fact and so state, the allegation is considered denied. Failure to deny any of the allegations in this Complaint will constitute an admission of the undenied allegation. ------- —12— The Answer shall also state the circumstances and arguments, if any, which are alleged to constitute the grounds of defense, and shall specifically request an administrative hearing, if desired. If you deny any material fact or raise any affirmative defense, you will be considered to have requested a hearing. The Answer must be filed with: Headquarters Hearing Clerk (A—hO) United States Environmental Protection Agency 401 M Street, S.W., Room M3706 Washington, DC 20460 Please send a copy of the Answer an all other documents which you file in this action to Vincent Giordano, the attorney assigned to represent EPA in this matter, at: Toxics Litigation Division (LE—134P) Office of Enfoccement and Compliance Monitoring U.S. Environmental Protection Agency 401 M Street, S.W., Rm. WE 113A Wasnlngton, D.C. 20460 INFORMAL SETTLEMENT CONFERENCE Whether or not you request a hearing, you may confer informally with EPA through Mr. Giordano regarding the facts of this case, or amount of the proposed penalty, and the possibility of settlement. An informal settlement conference does not, however, affect your obligation to file a written Answer to the Complaint. ------- —13— EPA has the authority, where appropriate, to modify the amount of the proposed penalty to reflect any settlement reached with you in an informal conference. The terms of such an agreement would be embodied in a Consent Agreement and Final Order (“CAFO”). A CAFO signed by EPA and you would be binding as to all terms and conditions specified therein upon signature by the EPA Chief Judicial Officer. Please be advised that the Consolidated Rules of Practice prohibit any ex parte (unilateral) discussion of the merits of any action with the Administrator, Cnief Judicial Officer, Administrative Law Judge, or any person likely to advise these officials in the decision of the case, after the Compliant is issued. PAYMENT OF PENALTY Instead of filing an Answer requesting a hearing or requesting an informal settlement conference, you may choose to pay the proposed penalty. Such payment should be made by sending a cashier’s or certified check payable to the United States of America in the amount of the penalty assessed in this Complaint. The check should be mailed to: EPA—Washington (Hearing Clerk) P.O. Box 360277M Pittsburgh, PA 15251 ------- —14— UNITED STATES ENVIRONMENTAL PROTECTION AGENCY TSCA 89—H— 22 Compi a i nant BY: Michael F. Wood, Director Compliance Division Office of Compliance Monitoring Date: ------- —15— CERTIFICATION I hereby certify that the original of the foregoing Complaint and Notice of Opportunity for Hearing, Docket No. TSCA—89—H—22 , has been filed with the Headquarters Hearing Clerk and that copies were sent, registered mail, return receipt requested to: Mr. David .7. Phillips President A]colac Incorporated 1099 Winterson Road Linthicum Heights, MD 21090 _________ _M JoL Date John E. Mason (EN—342) Document Control Officer U.S. Environmental Protection Agency 401 M Street, S.W. Washington, D.C. 20460 ------- U ------- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY In the Matterof: 3M COMPANY (MINNESOTA MINING AND ) Docket No. TSCA-88—H-06 AND MANUFACTURING), Respondent. S COMPLAINANT U.S. ENVIRONMENTAL PROTECTION AGENCY’S PRE—HEARING EXCHANGE By Letter dated October 5, 1988, as modified by Order dated December 13, 1988, the Court directed Complainant United States Environirental Protection Agency (EPA or the Agency) and Respondent 3M Company (3M), the Parties hereto, to file certain responses and documents by January 12, 1989 (the Pre—Mearing Exchanges). As this matter has not been settled, Complainant responds as follows to the Letter and Order . I. Witnesses To Be Called And Brief Narrative Summary Of Their Expected Testimony 1. Antony R. Ellis , Case Preparation Officer, Case Support Branch, Cospliance Division, Office of Compliance Monitoring. r. Ellis’ Program Description is attached hereto as Exhibit 12. Mr. Ellis will testify concerning the case development process for In the Matter of 3M Company . Mr. Ellis will ------- —2— outline chronologically all of the developments in this matter, from Complainant’s first contact with 3M to the filing of the Amended !int. Mr. Ellis will describe how the Complaint in this matter was prepared, explain briefly the Sections of TSCA violated by 3M, and show how the evidence in EPA’S possession supports the violations alleged in the Complaint. Mr. Ellis will also describe the process whereby the requisite Agency concurrences on this action were obtained prior to the filing of the Complaint , in accordance with established Agency policy. Finally, Mr. Ellis will explain how he calculated the adjusted proposed penalty in this case, and confirm that the penalty was calculated in accordance with the TSCA Section 5 and TSCA Sections 8, 12, and and 13 Enforcement Response Policies (Exhibits 17 and 18). 2. J. Mark Scoville, Jr. , TSCA Inventory Specialist, Chemical Inventory Section, Confidential Data Branch, Information Manangement Division, Office of Toxic Substances. Mr. Scoville’s Program Description is attached hereto as Exhibit 12. Mr. Scoville is one of the Agency’s foremost experts on TSCA Inventory matters, having worked on Inventory issues since the inceptt n of the Inventory in 1979. Mr. Scoville has personally nducted numerous searches of the TSCA Inventory, including the confidential portion of the Inventory not accessible by the general public. Mr. Scoville will explain how Inventory searches are conducted. Mr. Scoville will then testify with respect to the Inventory searches conducted in ------- —3— connection with this case, described in the Certified Statements of Linda A. Travers, Director, Information Management Division (Exhibits 2 and 6). Mr. Scoville will confirm that the Inventory searches are accurate and thereby demonstrate conclusively, as of the dates of the searches, the new chemical status of the 2 chemicals subject to this enforcement action (1—86—209 and 1—86—250). The two chemicals were “new chemical substances” until September 23, 1986, and October 7, 1986, respectively. 3. James W. Long , Economist, Regulatory Impacts Branch. Economics and Technology Division, Office of Toxic Substances. r. Long’s Curriculum Vitae is attached hereto as Exhibit 19. Mr. Long is a professional economist with special expertise in the area of econanic cost—benefit analysis and regulatory impact analysis. Among his accomplishments are his contributions to the “Regulatory Impact Analysis (RIA) for Title III of Sections 322 and 323 of the Superfund Amendments and Reauthorization Act of 1986” (Exhibit 20). In connection with the RIA, Mr. Long oversaw the development of an economic profile of those businesses in the Standard Industrial Classification (SIC) Code 28—XX ckemica1 manfacturers). 3M Company is included in this S!&Cod.. Mr. Long’s testimony regarding this economic profile will illuminate the issue of the proper levels of penalties to deter regulatory violations by the community of persons subject to premanufacture reporting. In addition, Mr. Long will discuss the impact of representative penalties ------- —4— calculated in accordance with the TSCA Section 5 and Sections 8, 12, and 13 ERPs on the ability of SIC Code 28—XX firms to “pay the penalties” and “continue in business” 1 r. Long -will also testify specifically regarding the impact of the adjusted proposed penalty in this case on 3M. The context of the discussion will include not only “ability to pay” and “ability to continue in business”, but the deterrence effect the penalty may be expected to have on 3M. Mr. Long will testify that, by any reasonable analysis, the impact of this penalty on 3M can only be characterized as minimal. In support of this conclusion, Mr. Long will discuss publicly available information, obtained by EPA, on 3M’s financial status. The information is based on documents filed by 3M before the U.S. Securities and Exchange Commission (Exhibit 21). The information supports Complainant’s conclusion that the expected impact of the penalty on 3M will be minimal. To place the information in the context of “everyday life”, Mr. Long will compare the impact of the adjusted proposed penalty on 3M with the impact an equivalent penalty would have on a natural person earning $67,038 per year before taxes. Mr. Long will calculate that, in these terms, based on 3M’s evEious income before taxes ($1,565,000,000.00), the impact of the adjusted proçosed penalty on 3M is roughly equivalent to the natural person paying a penalty of approximately 55 dollars and 96 cents (ExhibIts 21, and 22). ------- — 5-. 4. Phyllis E. Flaherty , Acting Director, Policy and Grants Division, Office of Compliance Monitoring. Ms. Flaherty’s Curriculum Vitae is attached hereto as Exhibit 23. Ms. F1ah rty is a recognized expert in EPA enforcement issues, with over 12 years experience in this field. Ms. Flaherty is presently the manager of the division within the Office of Compliance Monitoring responsible for the development of the Agency’s media—specific enforcement guidance for TSCA civil administrative enforcement actions, and in particular the TSCA Section 5 and Sections 8, 12, and 13 ERPs. Ms. Flaherty will testify that the ERPs, and th September 10, 1980 Guidance document, were developed in accordance. with, and conform to, the penalty factors in TSCA Section 16. She will explain how the ERPS comport with general Agency guidance regarding the assessment of civil penalties. Among the most important points Ms. Flaherty will emphasize is how the ERPs directly address the “potential harm, and actual harm, associated with the illegal import of new chemical substances. She will also explain that it is inappropriate to place penalty amount caps on the proposed penalties for this genre of violations. Ms. F2 rty will address directly the need for firm enforcement of the TSCA Section 13 import certification requirements. Ms. Flaherty will emphasize that the Agency’s TSCA Section 13 enforcement policies parallel the Congressional intent, as manifested in TSCA Sections 13, 15, and 16, that ------- —6— violations of TSCA Section 13 be considered separate and distinct violations. Ms. Flaherty will explain that the TSCA Sections 8, 12, and 13 ERP is specifically intended to address the Agency’s oncern that importers of chemical substances are often not themselves the manufacturers of the chemicals (and may therefore be less familiar with the TSCA premanufacture notification requirements), and/or tend to rely on heresay information or unchecked assumptions regarding the Inventory status of the imported chemicals, in place of personally conducting effective Inventory searches prior to import (as did 3M). For these and other reasons, the affirmative import certification requirements imposed on importers (but not domestic manufacturers) are considered an integral part of EPA’S overall strategy to effectively enforce the TSCA Section 5 premanufacture notification requirements. 5. Wendy Cleland—Hamnett , Deputy Director, Chemical Control Division, Office of Toxic Substances. Ms. Cleland—Haxnnett’s Curriculum Vitae is attached hereto as Exhibit 27. Ms. Cleland—Hamnett, having been professionally involved in the TSCA Section 5 new chemicals program since its inception in 1979, ii ong the most krtowledgable EPA managers in this field. Ni...Clsland—Hamnett will testify as to the critical importance of the new chemicals program in the Agency’s chemical regulation strategy, in the context of Agency enforcement guidance stressing the importance of the violated regulatory ------- —7— scheme as a key factor in generating an appropriate penalty. Ms. Cleland—Hamnett will also explain the multidisciplinary process whereby EPA determines the potential for new chemical substances toexhibit toxicity, calculates probable exposure levels, identifies data gaps, synthesizes and analyzes the results, and determines whether further regulatory action is appropriate. Such action is appropriate, Ms. Cleland—Hamnett will testify, when EPA can determine that there is “insufficient information to permit a reasoned analysis of the health of environmental effects” of the substance”, and either (1) the manufacture, import, processing, distribution in commerce, use and disposal of the substance “may present an unreasonable risk of injury to human health or the environment”, or (2) the substance “will be produced in substantial quantities” and “may reasonably be anticipated to enter the environment in substantial quantities or there ... may be significant or substantial human exposure to the substance”. TSCA Section 5(e)(l)(A)(i) and (ii). Upon making these findings, EPA may issue an order prohibiting or limiting the activities involving the substance pending the development of additional data to address th. potential risk. MS. C4!ind—Hantitett will emphasize that that the raison de etre of TSCA Section 5 Is to address potential , as opposed to actual, risk. EPA accomplishes this, inter alia , by identifying data gaps before there Is exposure to, or investment in, the chemicals. Consequently, the gravity of 3M’s violations ------- —8— can properly be considered oniy in the context of the prospective prevention of upotential harm which is the focus of the new chemicals program. Ms. Cleland—Hamnet is presently on detail to the immediate staff of the Administrator. Depending on her availability on the day of the hearing, Lawrence E. Culleen, Chief, Premartufacture Notice Management Branch, Chemical Control Division, Office of Toxic Substances, may testify as to the above matters in place of Ms. Cleland—Hamnett. Mr. Culleen’s Curriculum Vitae is attached hereto as Exhibit 28. 6. Charles M. Auer , Deputy Director, Health and Environmental Review Division (HERD), Office of Toxic Substances. Mr. Auer’s Curriculum Vitae Is attached hereto as Exhibit 30. Mr. Auer, who has been associated with the new chemicals program since its inception in 1979, manages the review of new chemical substances for potential health and environmental effects, and participated in the development of the Premanufacture Notification Exemption for Polymers at 40 CFR S723.250 (the polymer exemption rule). Mr. Auer will testify concerning the process whereby HERD reviews new chemical substances for potential h.ulth and environmental effects. Mr. Auer will testify th.e, statistically speaking, polymers encompassed by the polymer exemption rule are less likely to present unreasonable risks than are lower molecular weight substances. The TSCA section 5 ERP takes this factor into account by permitting ------- —9— substantially reduced penalties for polymeric Substances, Exhibits 14 and 15 describe how the adjusted proposed penalty in this case is over half a million dollars less than an equivalent penalty for a non—polymer. Mr. Auer will also explain, however, that many polymers do exhibit sufficient toxicity to trigger EPA concerns under TSCA Section 5. For this reason, Mr. Auer will testify that EPA found it essential, in drafting and promulgating the polymer exemption rule, to review each new polymer individually. in addition, EPA reserved the right to subject any polymer to the full 90—day Premanufacture Notice (PMN) review set forth in 40 CFR Part 720, under appropriate circumstances. In this context, Mr. Auer will explain that polymers may exhibit toxicity to humans, fauna, or flora, and will provide specific examples of such toxicity with reference to, among other things, polymers actually reviewed by EPA’S new chemicals program. 7. Dwain Winters , Acting Director of Budget, Office of Program Management and Evaluation, Office of Toxic Substances. The Program Description of the Office of Program Management and Evaluatjon is attached hereto as Exhibit 32. Mr. Wiatsre has been employed with EPA since its inception in 1970. In addition to his present position as Director of OPME, Mr. winters has served as a program analyst for the Budget Office of the Assistant Administrator of Air, Noise, and Radiation (1977—1982), and as the Director of the Office ------- —10— of Toxic Substances Policy Staff (1987—present). In these positions, Mr. Winters has developed considerable expertise in budget matters. Mr. Winters’ testimony, like Ms. Cleland—Ramnett’s, will reinforce the critical importance EPA places on the TSCA Section 5 new chemicals program. Mr. Winters, however, will approach the issue from a different angle. Mr. Winters, using hard budget data generated by the Comptroller’s Office (Exhibit 33), will testify that both the Congress and EPA have stressed the importance of the program by consistently allocating sufficient resources to enable the Office of Toxic Substances to achieve all of the significant goals of the program. Mr. Winters will testify that the resources expended on the new chemicals program are substantial in absolute terms. Mr. William’s will emphasize, however, that the the best measure of ‘program significance’, in budgetary terms, is the relationship of the resources allocated compared to the resources needed to accomplish the job. In this context, the new chemicals program must be viewed as a critical one, as the budget figures demonstrate a mature, yet still growing program which, as Ms. Cleland—Hamnett will testify, has for many y’s comp1ished its goals in a timely manner. 8. Other Witnessesi Complainant does not, at this time, anticipate the need to call any additional witnesses. Complain respectfully reserves the right, however, to supplement its witness list upon adequate notice to Respondent and the Court. ------- —11— II. Documents and Exhibits to Be Introduced Into Evidence Exhibit 1: Response of Information Management Division (IMD), Confidential Data Branch (CDB), Chemical Inventory Section (CIS) to 3M Bona Fide Intent to Manufacture inquiry for 1—86—209; TSCA Confidential Business Information (CBI) Document Control No. 59—86000715. Re ponse states that Y—86—209 does not appear on the TSCA Inventory of Existing Chemical Substances Master File (Inventory), thereby establishing 1—86—209’s status as a new chemical substance subject to TSCA Section 5. Exhibit 2: Certified Statement of Linda A. Travers, Director, IMD, dated September 23, 1986; TSCA CBI Document Control No. 20860002514. Statement provides that the chemical substance Y—86—209 was not included on the Inventory as of September 23, 1986. Exhibit 3: (1) Memorandum entitled, “Request for an Expedited Safety Review of a Chemical Substance (Y—86—209 ”, from A. C. Conroy II, Director, Office of Compliance Monitoring (0CM) to Rick Tinsworth, Acting Director, Office of Toxic Substances COTS), dated August 1, 1986; and (2) Memorandum entitled, “Safety Review [ of Y—86—209], from Rick Tinsworth, OTS, to A. E. Conroy II, dated July 31, 1986. Exhibit 4: Letter from John J. Neylan III, Director, Compliance Division, 0CM, to 3M, dated August 6, 1986. Letter authorizes 3M to continue to process and distribute 1—86—209 pending expiration of the 21—day polymer exemption application (PEA) review period. Exhibit 5: Response of IMD, CDB, CIS to 3M Bona Fide Intent to Manufacture inquiry for 1—86—250; TSCA Confidential Business Information (CBI) Document Control No. 59—86000225. Response states that 1—86—209 does not appear on the Inventory, thereby establishing Y—86—209’s status as a new chemical substance subject to TSCA Section 5. Exhibit 6s ? Crtif fed Statement of Linda A. Travers, Director, IND, dated October 21, 1986; TSCA CBI Document Control No. 20—870000116. Statement provides that the chemical substance 1—86—250 was not included on the Inventory as of October 7, 1986. ------- —12— Exhibit 7: Exhibit 8: Exhibit 9: Exhibit 10: Letter from 3M to John J. Neylan, III, 0CM, dated September 17, 1986; TSCA CR! Control No. HEN—293—86. Letter requests permission to continue to process and use y—86—250 pending expiration of the 21—day PEA review period. (1) Memorandum entitled, “Request for an Expedited Safety Review of a Chemical Substance [ Y-86—2501”, from A. E. Conroy II, Director, Office of Compliance Monitoring (0CM) to Rick Tinsworth, Acting Director, Office of Toxic Substances COTS), dated September 19, 1986; and (2) Memorandum entitled, “Safety Review (of Y—86—2501 ”, from Rick Tinsworth, OTS, to A. E. Conroy II, dated September 24, 1986. Letter and enclosures, from 3M to John J. Neylan, III, 0CM, dated November 18, 1986, TSCA CBI Control No. HEN—162—87. In this letter, entitled “Documents and Facts Concerning Import of 1—86—209”, 3M confesses to, and documents, all of the violations involving Y-86—209 alleged In the Amended Complaint . Letter and enclosures, from 3M to John J. Neylan, III, 0CM, dated November 7, 1986, TSCA CBI Control No. HEN—161—87. In this letter, entitled “Documents and Facts Concerning Import of 1—86—250”, 3M confessee to, and documents, all of the violations involving 1—86—250 alleged in the Amended Complaint . Exhibit 11: Letter and enclosure, from 3M to Antony (Tony) F llis, 0CM, dated September 4, 1987; TSCA CR! Document Control No. HEN—159—87. Letter contains use information on 1—86—209 and 1—86—250. Exhibit 12: Program Description (PD) for Antony R. Ellis, Case Preparation Officer, 0CM, Compliance Division, Case Support Branch (CSB). The PD describes Mr. Ellis’ professional duties and responsibilities. Exhibit 13: Penalty Calculations Worksheet, dated August 30, 1988. Worksheet describes in detail the bases for , the adjueted proposed penalty in the original .9.!2. Li.flt ($1,394,500). Exhibit 14i Penalty Calculations Worksheet, dated October 19, 1988. Worksheet describes in detail the bases for the adjusted proposed penalty in the Amended Complaint ($1,306,500). ------- —1.3— Exhibit 15: Penalty Calculations Worksheet, dated January 9, 1989. worksheet describes in detail how the adjusted proposed penalty in this case would have been calculated had the Gravity Based Penalty (GBP) component not been significantly reduced in the Amended Complaint to reflect the status of 1—86—209 and Y—86—250 as polymers (Si ,867,250). Exhibit 16: Penalty Calculations Worksheet, dated January 9, 1989. Worksheet describes in detail how the the adjusted proposed penalty in this case would have been calculated had the Gravity Based Penalty (GBP) component not been significantly reduced in the Amended Complaint to reflect the fact that EPA’S review of 1—86—209 and 1—86—250 did not identify any unreasonable risks of injury to human health or the environment (S2,8l1,500). Exhibit 17: “TSCA Section 5 Enforcement Response Policy (EPP), dated August 5, 1988. The adjusted proposed penalty in the Amended Complaint for the TSCA Section.5 premanufacture notification violations was calculated in full accordance with the TSCA Section 5 ERP. Exhibit 18: “Recordkeeping and Reporting Rules, TSCA Sections 8, 12, and 13 Enforcement Response Policy (ERP), dated May 15, 1987. The adjusted proposed penalty in the Amended Complaint for the TSCA Section 13 import certification violations was calculated in full accordance with the TSCA Section 13 ERP. Exhibit 19: Curriculum Vitae, James W. Long, Economist, OTS, Economics and Technology Division (ETD), Regulatory Impacts Branch. - Exhibit 20: Excerpts from the NRegulatory Impact Analysis in Support of the Final Rulemaking Under Sections 322—323 of Title III of the Superfund Amendments and Reauthorization Act of 1987, as updated by Mr. Long. The excerpts establish the median sales of businesses in Standard Industrial Classification (SIC) Code 28—XX, which includes 3M and other producers of new chemical substances. The economic status of this regulated community is relevant to the issue of the level of penalties necessary to deter regulatory violations, and the typical impact of penalties calculated in accordance with the TSCA Section 5, and TSCA Sections 8, 12, and 13 ERP5 on regulated entities in general. ------- -14— Exhibit 21: Disclosure Information Retrieval Service: 3M File. This file provides information on numerous important economic indicators, based on information filed by 3M with the U.S. Securities and Exchange Commission. The information addresses the impact of the adjusted proposed penalty on 3M, including lack of significant impact on 3M’s ability to pay and ability to continue in business. Exhibit 22: Worksheet: In the Matter of 3M Company: Relative Impact of Adjusted Proposed Penalty. This Worksheet demonstrates that the impact of the adjusted proposed penalty in this case on 3M is roughly equivalent to the impact a similar adjusted proposed penalty of approximately $55.96 would have on a natural person earning $67,038 per year. The conclusion to be drawn therefrom is that the impact of the adjusted proposed penalty on 3M is minimal. The Exhibit is also relevant to the issue of the deterrent effect the penalty may be expected to have on 3M. Exhibit 23: Curriculum Vitae. Phyllis E. Flaherty, Acting. Director, 0CM, Policy and Grants Division. Exhibit 24: “Guidelines for the Assessment of Civil Penalties Under Section 16 of the Toxic Substances Control Act”, 45 Fed. Reg. Reg. (September 10, 1980). Exhibit 25: (1) Memorandum entitled, “New Civil Penalty Policy”, from Courtney Price, Assistant Administrator, to Addressees, dated February 16, 1984; and (2) “ Policy on Civil Penalties : EPA General Enforcement Policy *GM—21 ”, dated February 16, 1984. Exhibit 26: “ A Framework for Statute—Specific Approaches to Penalty Assessments : Impementing EPA’S Policy on Civil Penalties: EPA General Enforcement Policy *GM—22’, dated February 16, 1984. Exhibit 27: Curriculum Vitae, Wendy Cleland—Ramnett, Deputy Director, Chemical Control Division (CCD), OTS. Exhibit 28s Curriculum Vitae, Lawrence Culleen, Chief, Premanufacture Notice Management Branch (PNMB), CCD, OTS. Exhibit 29: “New Chemical Review Process Manual”, dated March, 1986. The Manual describes in detail the review process for new chemical substances, including polymers, in effect at the time of 3M’s TSCA Section 5 violations. To the extent current practices may differ with the Manual, they will be identified by Ms. Cleland—Hamnett or Mr. Culleen. ------- —15— Exhibit 30: Curriculum Vitae, Charles M. Auer, Deputy Director, Health and Environmental Review Division (HERD), OT S. Exhibit 31: Charles M. Auer and David H. Gould, “Carcinogenicity Assessment and the Role of Structure Activity Relationship (SAR) Analysis Under TSCA Section 5”, F.nvir. Carcino. Revs. (J. Envir. Sci. Hith.), C5(l), 29—71 (1987). Mr. Auer will refer to, and explain this article in his testimony. Exhibit 32: Program Description (PD) for Dwain Winters, Director of Budget, Office of Program Management and Evaluation (OPME), OTS. The PD describes OPME’s duties and responsibilities. Exhibit 33: Excerpts from U.S. Environmental Protection Agency Budget Analysis Resource System: FY8O—88 Actuals: Pesticides and Toxic Substances. The excerpts describe actual levels of funding over time, in terms of both Full Time Employees (FTE’s) and Intramural and Extramural Dollars, for the new chemicals program. The figures are relevant to the N(ilmportance to the regulatory scheme, (‘,M—22 at 14 (Exhibit 26), of the sections of TSCA violated by 3M. Exhibit 34: Program Description (PD) for 3. Mark Scoville, Jr., TSCA Inventory Specialist, Chemical Inventory Section, Confidential Data Branch, IMD, OTS. Complainant does not, at this time, anticipate the need to introduce any further evidence. Complainant respectfully reserves the right, however, to supplement its exhibit list upon adequate notice to Respondent and the Court. In addition, Complainant may request the Court to take official notice of appropriat stters in accordance with 40 CFR S22.22(f). III. Location of the Hearing Complainant respectfully requests that the hearing in this matter be held in Washington, D.C. ------- —16— IV. TSCA Inventory of Existing Chemical Substances The TSCA Inventory is a lengthy and detailed document which lists literally thousands of chemical substances. Many of these substances are TSCA Confidential Business Information which Complainant is prohibited by TSCA Section 14 from revealing to the Respondent, absent a bona fide intent to manufacture as defined in 40 CFR S720.25(b)(2). Therefore, Complainant has not included a copy of the Inventory in this Pre—Hearing Exchange. To comply with the Court’s directive, Complainant has filed, inter alia , Exhibits 2 and 6, which are the Certified Statements of Linda A. Travers, the Director of the OTS Information Management Division, that 1—86—209 and 1—86—250 were not listed on the Inventory at the time of 3M’s violations. In addition, Complainant’s second witness, Mr. Scoville, will testify regarding the accuracy of the Inventory searches described in Ms. Travers’ Certified Statements, and explain in detail how the Inventory searches were conducted. V. Written Statements Furnished by 3M to Customs Officials compl.#nant has not endeavored to obtain the written statements vhich 3M furnished to the U.S. Customs officials from the Customs Service because the statements, as a matter of law, must have been false in this case. As explained In 40 CFR S707.20(2)(i) and (ii), any import of a chemical substance must be certified with the Customs Service, and ------- —17— only two certifications are permitted. They are: (1) the chemical substance complies with all applicable rules or orders under TSCA, or (2) the chemical substance is not subject to TSCA. See also 19 CFR SS12.118—12.127. Since the chemical substances in this matter were subject to TSCA, and 3M illegally imported them in violation of TSCA Section 5, there is no possible scenario in this case in which 3M could have not violated the import certification requirements. Furthermore, 3M, in documents provided to EPA (Exhibits 9 and 10), and in the Second Amended Answer , has admitted that 3M caused the false certifications to be made. VI. Response to Paragraphs 1, 5, 8, 9, 10, 14, 18, 21, 22, and 23 of the Second Amended Answer Paragraphs 5, 10, 18, and 23 of the Second Amended Answer describe two polymer exemption applications for the two new chemicals, which 3M submitted to EPA pursuant to 40 CFR §723.250. These polymer exemption applications were submitted to EPA after the violations set forth In the Amended Complaint occurred, and so are Irrelevant to 3M’s liability in this mat* . EPA confirms that the review period for both substances1I ired without EPA imposing any restrictions on subsequent manufacture, Import, and use of the substances. For this reason, Complainant has proposed signI ficantly lower penalties in this matter than authorized by law. Compare Exhibits 14 and 16. ------- —18— The two submissions described in Paragraphs 1, 8, 9, 14, 21, and 22, constitute Complainant’s Exhibits 9 and 10. Complainant has already adjusted the Gravity Based Penalties •in this mattet downward by a full 50% to reflect 3M’s prompt confession to EPA of the violations documented in Exhibits 9’and 10. VII. Import of Chemical Substances As Part of Mixtures On December 13, 1988, in response to Paragraphs 7 and 13 of the Second Amended Answer , and the affirmative defense “Computation of Count I Alleged Violation”, Second Amended Answer at 16-17, Complainant moved to amend the Complaint to eliminate all pre—August 30, 1980 TSCA Section 5 violations involving chemical substances imported as part of mixtures. By Order dated December 23, 1988, the Court authorized the amendment. This matter is therefore no longer at issue. VIII. Complainant’s Response to the Section of Respondent’s Second Amended Answer Entitled, “The Proposed Civil Penalties ’ Complainant has carefully reviewed the section of 3M’s Second Am.ndsd Answer entitled, “The Proposed Civil Penalties”. Complainant’s responses to the affirmative defenses entitled, “Statutes of Limitations (Counts I & III)” (at 14—15), “Substantive Due Process and Equal Protection” (at 16), and “Excessive Fines” (at 16), are set forth in Complainant’s ------- —19— December 29, 1988 Memorandum of Points and uthorities in Support of Motion to Strike Affirmative Defense , and January 6, 1989 Memorandum of Points and Authorities in Support of Second Motion to Strike Affirmative Defenses , incorporated herein by reference. The affirmative defense entitled, “Computation of Count I Alleged Violations” is no longer at issue in this case. See Section VII, supra . Complainant considers the remaining defenses in the Second Amended Complaint to lack merit. A point—by—point response follows. The responses are intended to provide the Court and 3M with full and fair notice of Complainant’s positions on these matters. To the extent 3M’s defenses have not been stricken prior the exchange of post—hearing briefs pursuant to 40 CFR S22.26 , Complainant will elaborate at that t i me. 1. 3M believed in good faith that 1—86—209 and 1—86—250 were on the Inventory when 3M imported them. To Complainant’s best knowledge, this statement is accurate. It does not, however, provide a defense to the penalty a sp.nt in this case. EPA assumed good faith on the part of 3M In selecting a civil administrative action as the appropriate enforcement response in this case, and generating the adjusted proposed penalty per the TSCA Section 5 and Sections 8, 12, and 13 ERPe. ------- —20— A company which knowingly and willfully imports chemicals in violation of TSCA may be subject to criminal penalties pursuant to TSCA Section 16(b), as well as increased civil penalties. No such responses are contemplated in this case, because there is no evidence to support any finding of “knowing and willful” misconduct on the part of 3M. 2. 3M ceased to import the chemicals when it learned that the chemicals might not be on the Inventory. t the point where 3M learned that the chemical might not be on the Inventory, 3M had “reason to know” that the import activities were in violation of TSCA. Complainant rejects 3M’s assertion that 3M now deserves to be rewarded with a further reduction in the adjusted proposed penalty for taking what Complainant considers to be the absolute minimum prudent and legally required action of ceasing the violative activities, pending a search of the Inventory and the review of the substances by EPA. 3. The illegally imported chemicals never presented an actual risk to h.a th or thi environment. 4. EPA reviewed notices (polymer exemption applications) for Y—86—209 and Y—86—250 and cleared both chemicals with no restrictions whatsoever. ------- —21— Complainant is most relieved that 3M’s violations in this matter did not appear to present any health or environmental risks, and that EPA was able to clear the chemicals without extending the review periods and regulating the substances under TSCA Section 5(e) or Cf). Complainant repeats that the Gravity Based Penalty in this matter is based on these findings. Compare Exhibits 12, 13, and 14. in this context, Complainant wishes to express its heartfelt prayer that we are never faced with a TSCA Sections 5 and 13 enforcement action in which actual injury is a factor in the case. Complainant is certain that the Parties are in complete accord on this score. Complainant views the enforcement of this case, and the imposition of the full adjusted proposed penalty, as promoting this result by emphasizing to 3M and the regulated community the importance of complying with the TSCA premanufacture review requirements. 5. 3M has cooperated fully with EPA regarding this case. Complainant agrees that 3M promptly self—confessed its illegal activities to EPA upon learning of them, and has provided EPI with documentation of the violations upon request. in recognittOn of this cooperation, Complainant has reduced the Gravity Based Penalty in this case by a full 50%. Complainant feels that this adjustment is most significant and adequately recognizes the degree of cooperation which 3M has exhibited to date in this matter. ------- —22— 6. 3M did not derive any significant economics benefits from its illegal activities. EPA’S enforcement policies consistently provide for civil penalties to be increased to recapture any economic benefits of non—compliance. See GM *21 (Exhibit 25) at 3, GM *22 (Exhibit 26) at 4, 11—12, and the September 10, 1980 “Guidance” (Exhibit 24) at 59774—5. The policies however, do not, and should not, provide for penalties to be further reduced due to lack of “gains from non—compliance”. Complainant has therefore neither increased nor decreased the penalty in this case based on the “gains from non—compliance” factor. 7. The TSCA—specific “Guidance” and ERPS are inconsistent with GM—21 and GM—22. This statement is at best, irrelevant. Moreover, it is inaccurate. GM—21 states: “The policies and procedures set out in this document and in (GM—22] are intended soley for the guidance of government personnel. They, are not intended and cannot be relied upon to create any rights, substantive or procedural, enforceable by any party in litigation with the U4t.d States. The Agency reserves the right to act at vaetanc. with these policies and procedures and to changs them at any time without public notice.” GM—21 at 7. This language speaks for itself. ------- —23— The cover memo to the policies, signed by the Assistant Administrator of the Office of Enforcement and Compliance Monitoring, further provides: ‘No attempt is made to address issues specific to each statute the Agency administers. Instead, this will be left to guidance developed by each program.’ Id. at 1. See also GM—21 at 1—2. The ‘Guidance’ and ERPS which Complainant used to calculate the adjusted proposed penalty in this case constitute precisely such ‘program—specific guidance.’ Moreover, because the Office of Compliance Monitoring has been formally delegated the authority to develop and issue such program—specific guidance by the Administrator, and the guidance was developed and issued in strict accordance with all applicable intra—Agency concurrence procedures, to the extent the TSCA—specific policies may in fact deviate from the general Agency—wide guidance, the deviations have been reviewed and formally approved by the Agency. The TSCA—specific documents thus represent the final word on Complainant’s position regarding the appropriateness of the adjusted proposed penalty in this case. The TSCA—specific guidance is in fact consistent with the GM—series policies with respect to the most Important aspects of the GM—series policies. Complainant’s witnesses will testify in detail regarding these and other factors: 1. ‘The first goal of penalty assessment is to deter people from violating the law.’ GM—21 at 3. 2. (TJhe penalty should persuade the violator to - take precautions against falling into non—compliance again (specific deterrence).’ Id. ------- —24— 3. ‘(The penalty should also] dissuade others from violating the law (general deterrence).” Id. 4. ‘Fair and equitable treatment requires that the Agency’s penalties must display both consistency and flexibility. The consistent application of a penalty policy is important because otherwise the resulting penalties might be seen as being arbitrarily assessed.’ Id. at 4 5. “ Gravity Component . [ Tihe following factors should be considered: a. actual or possible harm b. importance to the regulatory scheme ...“ GM—22 at 3. 6. “ Size of violator: ’ Id. at 15. 7. “ The length of time a violation continues: ’ Id. This is, of course, only a partial listing of the penalty factors in the two GM—series documents. 3M may direct questions to Complainant’s witnesses regarding any other factors at the hearing. One additional word on ‘consistency’: It is said that, “one cannot have his cake and eat it too.’ The TSCA ERPs are progressive in a number of important ways. The 50% self—confessor adjustment included in the Amended Complaint in this case, for example, is not routinely available in complaints for enforcement of violations in other other environmental media, i.e., Clean Water P t c p1aints. It is not difficult to imagine what 3M’s respon would be if Complainant, in response to the ‘GM—series’ defense, eliminated the self—confessor reductions in this case. It appears that 3M is more than willing to tolerate program—specific differences when it suits 3M’s purposes to do so. ------- —25— 8. “ Inventory Reporting (Count I) ” This curious defense would have the Court reduce the adjusted proposed penalty in this case to reflect the fact that 3M not only violated the pren anufacture notification requirements, but the Inventory Reporting Rule as well. Not only does this assertion violate “the well—worn adage that ‘two wrongs do not make a right’”, Gray v. Mississippi , 481 U.S. —, 95 L. Ed. 2d 622, 636 (1987), it ignores EPA’s attempts, in the early days of the Inventory, to bend over backward to accomodate late reporters. Furthermore, 3M’s suggested approach would serve to discourage persons who manufacture or import large quantities of chemicals over long periods of time from ever taking a second look at their continuing activities in light of the magnitude and duration of the activites. 3M cannot insulate itself from liability for its premanufacture notification violations by having violated the Inventory Reporting Rule. In fact, as EPA has stated repeatedly, the opposite is true: a chemical substance not listed on th. Inventory for any reason is by operation of law a “new chia ca1 substance subject to the premanufacture notificati requirements. EPA provided early notice of these requirements in numerous Federal Register Notices, including “Inventory Reporting; Statement of Policy”, 45 Fed. .!! ‘ 26452 (April 18, 1980). In fact, EPA did not, at first, strictly enforce ------- —26— the TSCA Section 5 premanufacture notification requirements for an 11 month period from July 1, 1979 to May 19, 1980, specifically to provide all manufacturers and importers with an additional opportunity to recheck the Inventory status of their chemicals. Furthermore, as discussed supra , EPA did not apply the TSCA Section 5 requirements to new chemicals imported as parts of mixtures until August 30, 1980. 3M should therefore accept the responsibility for the fact that it chose not to avail itself of these repeated opportunities to come into compliance with the law. The April 18, 1980 Notice informed all manufacturers and importers that, effective May 19, 1980, the premanufacture notification requirements would become effective, and late Inventory reports would no longer be accepted. EPA stated: “EPA’S Office of Enforcement will strictly enforce this deadline, and will assess penalties under section 16 of TSCA against any person found to be in violation of the statutory and regulatory requirements of TSCA concerning premanufacture notification.’ Id. In a second Notice entitled. ‘Availability of TSCA Revised Inventory’, 45 Fed. . 50544 (July 29, 1980). EPA again informed all manufacturers that late Inventory reports would no longer accepted. EPA repeated this information in other published documents and on numerous occasions. ------- —27— 3M appears to hold the opinion that once a manufacturer or importer makes an Inventory determination, even where the determination is not based on a personal search of the Inventory but relies on unchecked assumptions or heresay, the person need never consider revisiting the matter regardless of the person’s continuing manufacture or import of the substance over many years. This is bad law, it is bad policy, and it is not acceptable to the Complainant. 9, PMN Reporting (Count III) : The above arguments also apply to the issue of the appropriateness of penalty 0 caps’ given 3M’s continuing Illegal import of new chemical substances over time. Complainant has explained supra the prospective focus of TSCA Section 5 with respect to potential. risk. Complainant repeats herein that Complainant is relieved that no actual risk occured, as the result of the 3M’s TSCA violations, this time . Experience dictates however, that potential exposure, and therefore potential risk, may be directly proportional to the quantity, and number of batches produced, of a toxic chemical substai e. Experience further dictates that chemicals for which thsr• may be no immediate reason to suspect the potential for health or environmental risks may later be determined to present serious risks. The legislative history of TSCA is replete with such examples. This is, In fact, the bottom line of what is really at stake in this case. ------- —28— Furthermore, “potential. risk” does not manifest “for subsequent days at decreasing levels”, Second Amended Complaint at 12—13. Neither should the penalties for 3M’s repeated illegal imports in this case. 10: “ Import Certifications (Counts II and IV) ” A summary of the reasons why it is critical that the import certification violations, which even 3M does not deny are clearly discrete TSCA violations, are separately penalized, appears supra in the discussion of Complainant’s fourth witness, Ms. Flaherty’s, intended testimony. 11. “ Administrative Procedure Act 3M’s contention that the TSCA Section 5 and Sections 8, 12, and 13 ERPS operate as “binding rules”, Second Amended Answer at 15, is legally unsupportable. Even if it is assumed that Complainant has calculated every TSCA penalty ever proposed strictly according to the ERPs, the proposed penalty in this case, in and of itself, imposes absolutely no legal. obligation on 3M. Of course, the adjusted proposed penalty in this ca was calculated by an Agency enforcement official in the performance of his professional duties, and so is entitled to the requisite deference. It is in the end analysis, however, the Administrative Law Judge (AU) or Chief Judicial Officer who will issue the Final Order in this case, not the ------- —29— Complainant. See 40 CFR §S22.27-.32. By that time, 3M will have had its day in court. IX. The Adjuited Proposed Penalty Accords With All Applicable Penalty Guidelines and Enforcement Response Policies (ERPs ) The Penalty Calculation Worksheet in this action, attached hereto as Exhibit 14, outlines how the adjusted proposed penalty in this case was calculated. The calculations therein are based on the “Guidelines for the Assessment of Civil penalties Under Section 16 of TSCA”, and TSCA Section 5 and Sections 8, 12, and 13 ERPs, attached hereto as Exhibits 17, 18, and 24, respectively. Complainant’s first witness, Mr. Ellis, personally prepared Exhibit 14 and will testify concerning the calculations, Complainant’s fourth witness, Ms. Flaherty, is the Acting Director of the 0CM Policy and Grants Division (PGD). The The PGD is responsible for generating TSCA penalty policy guidance for the Agency. Ms. Flaherty will describe how the “Guidelines’ and ERPS were developed and operate. Respectfully submitted, Date 0 0. Silberman orney TOXiCS Litigation Division Office of Enforcement and Compliance Monitoring ------- CERTIFICATION OF SERVICE I hereby certify that the originals of the foregoing Complainant U.S. Environmental Protection Agency’s Pre—Hearing Exchange , and the following Exhibits , Docket No. TSCA—88—H—06, have been filed with th Headquarters Hearing Clerk, and that copies were hand—delivered, or sent by First Class Mail, to: Hon. Henry B. Frazier, III Administrative Law Judge Office of the Administrative Law JudgeS (A—hO) U.S. Environmental Protection Agency 401 M Street, S.W. Washington, D.C. 20460 Blake L. Biles, Esq. Jones, Day, Reavis & Pogue 1450 G Street, N.W. Washington, D.C. 20005—2088 Date I/i /g1 rma n ics Litigation Division (LE—134P) U.S. Environmental Protection Agency 40]. M Street, S.W. Washington, D.C. 20460 ------- V ------- C — MOTION TO STRIKE ?iYFIR1 T!VE DEF JSES Complainant U.S. Environmental Protection Agency respectfully moves, pursuant to 40 CFR S 22.16 of the Consolidatid Rules of Practice, for an Order to strike Respondent’s Second. Third, and Fourth Affirmative Defenses from the Respondent’s Mayer. The grounds for striking the ‘Affirmative Defenses’ are as follows: the Defenses (1) are insufficient as a matter of law; (2) are immaterial, impertinent, and/or frivolous; and (3) significantly confuse the issues in the case. In support of this Motion, Complainant files the attached Memorandum of Points and Authorities In su ort of Motion to Strike Affirmative Defenses , incorporated herein by reference. Respectfully submitted, . , Dated: __________ Vincent Giordano, Esq. Toxics Litigation Division Office of Enforcement and Compliance Monitoring S.. UNITED STATES JVIRONMENTAL PROTECTION AG CY In the Matter of: ) ) TRDICO, INC. INCON DIVISION ) BARBOURVILLE, XDITUCXY ) ) Respondent ) ) Docket No. T$CA-88-H-OS ------- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY In the Matter-of ) ) TRDICO, INC. ) INCON DIVISION ) BARBOURVILLE, KENTUCKY ) ) Respondent ) ) Docket No. TSCA-88-N-05 • MEMORANI)UM OF PO!NTS )IND M1TM0RTT1 S TN SUPPORT • OF MOTION TO STRIKE AFFIRP ITIVK D!F SKS I. Introduction Complainant U.S. Environmental Protection Agency (EPA) respectfully moves pursuant to 40 CFR 522.16 of ths Consolidated Rules of Practice, for an Order to strike Respondent’s Second, Third, and Fourth Affirmative Defenses from the Respondent’s Answer. The grounds for striking the Affirmative Defenses are as follows: the Defenses” (1) are insufficient as a matter of law; (2) are iiwnaterial, impertinent, and/or frivolous; and (3) sIgnificantly confuse the issues in the case. To expedite the administration of justice and avoid prejudice to the Complainant, the ‘Defenses should be stricken from the Answer. II. Statement of ha Ca e On October 21 and 22, 1987, an authorized EPA inspector lawfully inspected Respondent’s Barbourville . Kentucky, facility pursuant to SectIon 11 of the Toxic Substances Control Act (TSCA). 15 U.S.C. 55 2601 g . One of the purposes of this inspection was to review Trepico’s TSCA compliance in regards to three particular chemical substances. These three substances were of ------- —2— particular interest because in the cover aemorandwn used by Treaco to transmit the Premanufacture Notices (P?*Js) to EPA, Tremco stated that ‘Tremco manufactures and uses [ these substances] as site- limited or as industrial (compounds] . . . ., and EPA, in its review of the P V4s, had determined that these substances were not on the TSCA Inventory and hence, were new chemical substances. During the October, 1987 inspection, EPA obtained from the Respondent information which showed that Respondent had manufactured all three substances for commercial purposes prior to submitting the P Js for these substances, in violation of TSCA 5 5. TS A 5 5 provides that no person may manufacture a new chemical substance unless they have notified EPA of their intent to manufacture, at least 90 days prior to Such manufacture. Failure to provide notice is a prohibited act under S 15 of TSCA, for which EPA may assess a penalty under 5 16 of TSCA. As a followup to the inspection, EPA’S inspector requested Information regarding the production of theses substances during the P?.VJ review period. Tremco provided this information by letter dated January 13. 1988. Tremco informed EPA that, in addition to manufacturing these substances prior to submitting the P) s, Tremco had also manufactured two of thes. three substances during their respective Pill review periods. On July 20. 1988, EPA filed a civil administrative Complaint against Tremco seeking penalties for failing to properly submit PMN5 for these three substances. Counts 1 through 57 of EPA’s complaint i]1eg that the manufacture of these substances prior to the ------- —3— submission of their respective PlflJs was in violation of TSCA and rules promulgated thereunder. Counts 58 and 59 of EPA’S complaint allege that the two occasions of manufacture during the P)’2J review period also violated TSCA and rules promulgated thereunder. The factual and legal basis for the Complaint an, fully described ifl the Complaint, and incorporated herein by refsr•nce. On AuguSt 16, 1988, EPA Utended the complaint as a matter of right. The amendment was necessitated by the promulgation of a revised TSCA S 5 Enforcement Response Policy, and resulted in a 61.6% reduction in the proposed penalty. Respondent filed a timely Answer to EPA’s complaint. In Part II of the Answer, Respondent set forth three Affirmative Defenses. Complainant respectfully submits that the following defenses must be stricken from the Answer: “Second Defense - Tremco incorporates by reference the admissions, averments and denials set forth above and avers that the claims set forth in Counts 1 through 57 are barred by the applicable statute of limitations. Third Defense Trutco incorporates by reference the admissions, avirments and denials set forth above and avers that the claims set forth in Counts 1 through 59 ar. barred by the doctrines of laches, waiver and estoppel. Fourth Defense — Trutco incorporatss by reference the admissions, averments and denials set forth above and avers that the total adjusted pToposed penalty sought in the Amended Complaint is ------- —4- inconsistent with Agency policy and unreasonable in light of the circumstances of the alleged violations.’ III. Araument A. The ADoroDriate Leaal Standard For Strikina ‘Affirmative Defenses’ From a ComDlaint Is To Strike ‘Defenses’ Which Are Leoallv Insufficient. Immaterial. ImDertinent. And/or Frivolous The Consolidated Rules of Practice, at 40 CTR S 22.16, authorize a party to make any written motion in an action. They do not set forth any specific criteria governing the matter which may appropriately be stricken from an Answer on a Motion to Strike Affirmative Defenses. Complainant submits that the legal standards for reviewing such a Motion under Federal Rule of Civil Procedure 12(f), 28 U.S.C. Rule 12(f), are appropriate standards for reviewing the instant motion. This rule authorizes the Federal Courts to strike, inter slip , any insufficient defense or any immaterial of impertinent matter from any pleading. Z.g.. Although Motions to Strike are not always favored by the Courts and should be granted only when the matters to be stricken are clearly inadmissible or unrelated to the controversy. 2k MOORE’S FEDERAL PRACTICE S 12.21 ( 2nd Sd. 1987). the recognized function of this Motion is to ‘expedite the administration of justice ’. American Machine & Metals. Inc. v De Bothezat I eller Co. mc . , 8 F.R.D. 306, 308 (S.D.LY. 1948). ‘Weeding out legally insufficient defenses at an early stage’ in the proceeding can prove to be “extremely valuable to all concerned’ - including the Court - by vold i’g “the needless •xpend2tures of time and money’ in ------- —5— litigating issues which can be foreseen to have no bearing on the outcome’. Narraaansett Tribe of 1ndian v. Southern Rhode Island Land Develo ment Core. , 418 F. Supp. 798, 801 (D.LI. 1976). This is especially true for defenses which would substantially complicate the discovery proceedings. In such an action, a hearing is unnecessary. U.S. V. 416.51 Acres of Land , 514 T.2d 627, 630 (7th Cir. 1975). Indeed, the Notion to Strike is recognized as “a useful and appropriate tool’ for weighing the legal implications to be drawn from uncontroverted facts.’ at 631, citing 5 C. Wright & A. Miller, FEDERAL PRACTICE AND PROCEDURE: CIVIL 51381 (1969). Striking clearly insupportable issues or defenses, such as those raised by the Respondent and discussed below, further supports the administration of justice by avoiding defenses which, if pleaded, would only serve ‘to confuse the issues’ and create the possibility that extraneous considerations could enter into the judicial decisionmaking process. Sun Insurance ComDanv of New York v. Diversified Engineers. Inc. , 240 F. Supp. 606, 612 (D. Mont. 1965). Such a result could skew the proceeding in an unreasonable and unjust direction, thereby causing significant prejudice to the Ilovant. Thi prejudice can be exceptionally egregious where the effect of allowing a party to prove a legally insufficient defense at hearing would, in addition to causing confusion and unduly lengthened proceedings, evoke undeserved sympathy for the party. Narraaansett Tribe at 802. A defense is insufficient as a matter of law when it would not, un ier any facts proved In support of the allegation, constitute ------- —6— a valid defense. Sun Insurance Co . at 612. Such a defense can have no possible bearing on the subject matter of the litigation, and should be stricken. When the defense, at first glance, is Clearly invalid as a matter of law, it may be characterized as ‘patently frivolous’ and promptly stricken. Anchor Hockina COrE. V. Jacksonville Electric Authority , 419 F. Supp. 992, 1000 (M.D. Fl. 1976). A ‘frivolous’ defense has also been d.fin.d as one that ‘can be seen as merely pretensive, setting up some ground that cannot be sustained by argument.’ BLACKS LAW DICTIONARY 378 (5th Ed. 1979). An “immaterial” defense is a defense which bears ‘no essential or important relationship to the claim for relief, Gilbert v. Eli Lilly & Co. Inc. , 56 F.R.D. 116. 120 n.5 (D. Puerto Rico 1972), or is simply “outside the scope of the action.’ American Sheet Metal Inc.. v. Em-Xav Enaineerinc Co. , 478 F. Supp. 809, 815 (E.D. Ca. 1979), citing Sheppard’s ? . NUAL OF FEDERAL PRACTICE, 2nd ed. 345. An “impertinent’ defense is any defense which is neither responsive nor relevant to the issues involved in the action and which could not be put in issue or be given in evidence between the parties.’ Gilbert at 120, n.6. In summary, litigating legally insufficient, immaterial, impertinent, and frivolous affirmative defenses causes needless expenditures of time and money and deflects the attention of the parties and the court from the true issuu at hand. To avoid confusing the issues and prejudicing the Movant, they should be stricken from the pleading. ------- —7— 3. Res ondent’s Second Defense Is Insufficient As A Matter of Law And Should Be Stricken Respondent’s Second Defense reads, in relevant part, as follows: ‘Tremco . . . avers that the claims sit forth in Counts 1 through 57 are barred by the applicable statute of limitations. The Court should strike this defense as insufficiant as a matter of law, as there is no applicable statute of limitations that applies to TSCA administrative enforcement actions. Further, retention of this defense until hearing will require the parties to engage in extensive discovery concerning when EPA knew of these violations, and proof of this defense by Respondent would confuse the issues and prejudice the EPA. 1. The Federal Government Is Not Sound By A Statute Of Limitations Unless Conaress Has Clearly Manifested An £xDlicit Intent That The Government Is So Bound . The general rule is that the United States is not subject to statutes of limitations in enforcing its rights unless Congress explicitly provides otherwise. United States v. City of Palm Beach 635 F. 2d 337, 339 (5th Cir. 1981). cert. denied 454 U.S. 1081 (1981). It is settled beyond doubt or controversy — upon the foundation of the great principle of public policy . . which forbids that the public interests should be prejudiced by the negligence of the officers or agents to whose care they are confided - that the United States, asserting rights vested in it as a sovereign ------- —8— government, is not bound by any statute of limitations, unless Congress has clearly manifested an intention that it should be so bound. United States y. Nashville. etc. Railway Com any , 118 U.S. 120 125 (1886). [ IJt is to be observed that statutes of limitations, in the absence of specific statutory provisions otherwise, do net run against the Federal Governmsnt. 3-82604 28 Coap. Gin. 624, 625 (1949). It is veil established the Congress may create a right of action without restricting the time within which the right must be exercised. Occidental Life Insurance Co. v. EKOC , 432 U.S. 355 (1977). In Public Interest Research Grout of New Jersey v. United States Metals Refining , 681 F. Supp. 237, 239 (D.N.J. 1987) the Court held that no statute of limitations applies to enforcement actions taken under the Clean Water Act. In enacting TSCA and a subsequent amendment thereto, Congress did not and has not restricted EPA’s ability to take administrative enforcement actions by enacting a TSCA statute of limitations. See 15 U.S.C. S 2601 — 2629 and the 1986 amendment to TSCA, the Asbestos Hazard nergency Response Act 15 U.S.C. 2641 — 2654. EPA contends that without a statute of limitations which expressly restricts EPA’s ability to take TSCA administrative enforcement actions, the general rule of law applies, and this present action is not time- barred. ------- —9— 2. The A nro riate Leosi Standard for A lvina a General Statute of Limitations )aainst the Federal Gavernment Is That The General Statute Must Be Strictly Construed In Favor Of The Government . Although not expressly stated in Respondent’s Answer, Complainant assumes that Respondent wishes to invoke a general statute of limitations to bar this administrative •nforcement action. Such a general provision is provided at 28 U.S.C. S 2462. Section 2462 states ‘ [ ejxcept as otherwise provided by Act of Congress, an action, suit or proceeding for the enforcement of any civil fine, penalty of forfeiture, pecuniary or otherwise, shall not be entertained unless commenced within five years from the date when the claim first accrued ....‘ Complainant submits that the Court must strictly construe S 2462 in favor of EPA. and such a strict construction necessitates striking this defense from Respondent’s Answer. The Supreme Court has pronounced the standard for the proper construction of statutes of limitations. “‘Statutes of Limitation sought to be applied to bar rights of the Government, must receive a strict construction in favor of the Government..’” Badaracco at al v Commissioner of Internal Revenue , 464 U.S. 386. 391 (1984) (quoting B. I. duPont de Nemours & Ce. v. Davis , 264 U.S. 456, 462 (1924)). “(L)imitations statutes barring the collection of taxes otherwise due and unpaid are strictly construed in favor of the Government.” Lucia v United LItL5. 474 F.24 565, 570 (5th dr. 1973). Strict construction of 28 U.S.C. S 2462 begins with a review of its en tment as part of the revision and codification of Title ------- —10— 28. United States Code. Judiciary and Judicial Procedure 62 Stat 869 (1948). This-1948 law pertains only to the ‘Courts of the United States’ which are defined in 28 U.S.C. S 451 as ‘the Supreme Court of the United States, courts of appeals, district courts . . ., the Court of Claims, the Court of Customs and Patent Appeals, the Customs Court and any court created by Act of Congress the judges of which are entitled to hold office during good behavior.’ Clearly, EPA’S administrative proceeding is not encompassed by this definition, and Complainant submits that Congress did not intend that S 2462 apply to an EPA administrative hearing. Congress Intended 28 U.S.C. S 2462 to apply to actions taken in the Courts of the United States as evidenced by the texts of 28 U.S.C. SS 2461(a) and 1355. In S 2461(a) Congress authorized the Federal Government to take a civil action to recover or enforce a civil fine whenever the mode of recovery had not been prescribed. In S 1355 Congress provided jurisdiction for these actions - “the district courts shall have original jurisdiction . . . for the recovery or enforcement of any fine . . . incurred under any Act of Congress.’ at 934. EPA’s position is that Congress, in turn, provided in 5 2462 a statute of limitations to apply to those actions, which it had, in this law, prescribed both a mode and a jurisdiction for recovery. Thus, while, the Respondent would prefer that the Court look only to S 2462 of the Statute, the Court must look at the statute as a whole. ------- —11— A strict, and accurate construction of 5 2462 indIcates that 5 2462 applIes to civil judicial enforcement actions which seek to enforce a penalty In the U.S. District Courts, and not to administrative enforcement actions which seek to aas•is an administrative penalty. Chief Administrative Law Judge Harwood analyzed this issue similarly in the Memorandum and Order in In the Matter of Union Carbide , Docket No. TSCA-85-M-02 (October 3, 1985). In this case Judge Harwood stated ‘(tjhe question izvnediately raised Is the validity of Union Carbide’s assumption that 28 U.S.C. 2462, applies to the institution of proceeding on an administrative complaint before an agency, as distinguished from a court proceeding to assess a penalty or to enforce an administratively imposed penalty. Since Title 28 applies to proceedings in the United States courts, it would seem that it would not. at 6. Bolstering Judge Harvood’s view are those decisions which determine the point in time that a claim first accrues under 5 2462 or the other general statutes of limitations provided in Title 28. The United States Supreme Court addressed this issue in Cro m Coat rz.wit Co. V. United States , 386 U.S. 503 (1967). In this case, the Plaintiff had brought suit against the Federal Government in U.S. District Court more than six years after completing the performance of a contract. The United States claimed that the suit was time- barred by the g•neral six year statute of limitations provision S 2401(a). The Court held that the claim was not time-barred because the underlying claim did not accrue until the completion of the adjii nistratIve proceedings. 1 . . at 511. The Court went on to ------- —12— say that ‘the ‘right of action’ of which S2401(a) speaks is not the right to administrative action but the right to file a civil action In the courts against the United States.’ J . This same line of reasoning was followed by the Seventh Circuit in U.S. DeDartment of Labor V. Old Ben Coal Com anv , 676 F.2d 259 (1982). In this case, Old Ben had violated the Federal Coal Nine Health and Safety Act in 1973 and had raised S 2462’s as a defense to the Federal Government’s enforcement proc•eding. In 1974, the Department of Interior sought to assess civil penalties against Old Ben for the sixteen 1973 violations of the Coal Act. The administrative law judge issued a decision in favor of the Government on June 23. 1975 which became final on July 23. 1975. Old Ben failed to pay the assessed penalties and the United States sued on July 18, 1980 in U.S. District Court to enforce the July 23. 1975 order. The court held that in the context of the Coal Act the district court claim accrues only after the administrative proceeding has ended, a penalty has been assessed, and the violator has failed to pay the penalty. The Coal Act states specifically that the Secrstary shall file a petition for enforcement of the order asssuing the civil penalty only if the person against whoa the penalty was assessed falls to pay it within th. time prescribed in the order. . . Obviously, an administrative agency order must exist before the Secretary can file a district court action to enforce It. Therefore, if 28 U.S.C. S 2462 applies to ------- —13— the district court proceeding the limitations period begins tO run when the administrative order becomes final. at 261. Important to note at this point, is that Congress set up the same type of enforcement mechanism in TSCA. Section 16 of TSCA provides that penalties are to be assessed by the Administrator by an order made on the record after opportunity for a hearing, and if any person fails to pay an assessed civil penalty, the Attorney General shall recover the amount assessed in an action brought In an appropriate United States District Court. The First Circuit court apparently found the rational of Crown Coat and Old Ben meritorious. In United States v. Mever 808 F 26 912. 916 (1st Cir. 1987) the Court noted that “the use of the word ‘enforcement’ in 28 U.S.C. 5 2462 is not without significance; the noun by definition . . . presupposes the existence of an actual penalty to be enforced. The Court went on to say that ‘(o]utside of the Fifth Circuit, no court has ever held that, in a case where an antecedent administrative judgment is a statutory prerequisite to the maintenance of a civil enforcement action, the limitations period on $ recovery suit runs from the date of the underlying violation as opposed to the date on which the penalty was administratively imposed. . at 916. Other Courts hays strictly construed the extent of 5 2462’s applicability, and have reached the same conclusion - 5 2462 does not apply to bar Federal Government claims to assess penalties. These Coerts, however, addressed the issue of what type of penalty ------- —14— is encompassed by 5 2462, rather than addressing the issue of applicability in terms of when a claim accrues. In United Stat. 207 F.2d 796, 798 (5th dr. 1953) the Federal Government sought to recover from the defendants $10 .000, $2,000 for •ach of f lvi separate fraudulent acts. The defendants raised S 2462 as a defense and the Court held that the action was not a criminal prosecution, nor a civil action for a penalty, it was, however, a civil sanction to recover an award of damages of a compensatory nature. 1 See also United States v. Schneider , 139 F. Supp. 826. 828 (S.D.N.Y 1956) 9tjhe availability of S 2462 as a defense turns upon whether . . . the Surplus Property Act . . . imposes a civil penalty or a civil sanction of a remedial character. This was the line of reasoning chosen by EPA Administrative Law Judge Jones, in the Matter of 3.V . Peters and eom nv , RCRA Docket Number V-W-8l—R-75 (Initial Decision 1988). In 3.V. Peters , the Federal Government sought to assess a $25,000 penalty in November of 1987 for violations uncovered in December of 1980.2 The respondent raised 5 2462 as a defense and Judge 1 jones held that S 2462 does not apply to a Resource Conservation and Recovery Act 1 Important to note is that the Court in recognized; the general rule that statutes of limitations do not ordinarily run against the United States, that S 2462 is an exception to the general rule and is in derogation of an inherent attribute of sovereign i unity. United States v. Weaver , 207 F.2d 796, 798 (5th Cir. 1953) 2 S 3008(g) of RCRA states ‘(amy person who violates any requirement of this subchapter shall be liable to the United States for a civil penalty in an amount not to exceed $25,000 for each such uio]ation. Each dRy of such violation shall, for purposes of this subsection, constitute a separate violation.’ ------- —15— (RCRA) enforcement action. He held that a RCRA enforcement action Bought ‘a civil administrative sanction, regulatory in nature and remedial in charact•r, and is not considered penal in any sense, but assessed for the Bole purpose of achieving compliance with the Act.’ I d. at 9. Complainant submits that there is no significant difference between the language of 53008(g) of RCRA and 516(a), 3 nor in Congriss’ intent in enacting these administrative sanctions. Therefore. Complainant argues that the rationale used by the Court in 3.V. Peters applies directly to this case, and as such requires the Court to strike Respondent’s statute of limitations defense. Assuming arauendo that 28 U.S.C. 5 2462 applies to TSCA administrative enforcement actions. EPA argues that the five years begins to run at. the time EPA became aware of the violations. EPA maintains that Respondent’s violations where continuing violations which were corrected by the filing of P? Is for each of these substances on July 21, 1983. On this date EPA became aware of the violative acts alleged in Counts 1 through 57, and therefore, the Complaint, filed on July 20. 1988. was filed within the five year limitations period. In United States v. Advance Nachinerv Co . • 547 F. supp. loss (D. Minn. 1982), the Court found that a failure to report information under the Occupational Safety and Health fAct was a continuing violation after finding that th. consequences of a failure to report health and safety information had potential direct 3. Section 16(a) of TSCA states ‘ [ amy person who violates a provision of section 15 shall be liable to the United States for a ‘ lvi i pQna]ty in an amount not to exceed $25,000 for each such violation. Each day such a violation continues shall, for purposes of this subsection, constitute a separate violation of section 15.’ ------- —16— and continuing public consequences. The court noted that the reporting requirements would be frustrated if a manufactur•r could successfully hide evidence of a product defect for five years. 547 F. Supp. at 1090. Advance Machinery’s holding is applicable to the continuing risk assessment program set up by in Congress in TSCA. and EPA in 40 C.F.R. Part 720. In enacting TScA, congress intended to provide protection against unreasonable risks associated with the chemicals that have been, and those that may be, introduced into co erc•. This vast volume of chemicals have, for the st part, been released into the environment with little or no knowledge of their long term health and environmental effects. As a result, chemicals currently in coivinercial and household use are now being found to cause or contribute to health or environmental hazards unknown at the time commercial use of the chemicals began. Leg Hist. at 411 (House Report at 3). gg aJag Leg. Mist. at 159 - 161 (Senate Report at 3—5). It is imperative, therefore, that the integrity of Congress’s Premanufacturs Review Strategy not be undermined by the ability of a person to hids a violation for a period of mon than five years. The Court in Uniøn Carbide , i u. followed the rationale of Advance Machinery . Although Judge )Iarvood stated that he believed S 2462 did not apply to a TSCA administrative proceeding. he vent on to find that EPA was not barred in any event, because the complaint ha. been I iJed within five years from the date that EPA knew of the ------- —17— violation. In Union Carbide , the violation occurred in 1977, it became known to EPA in September of 1983, and EPA fil•d a complaint against Union Carbide in Sptember of 1985. Although a decision that S 2462 appliss to this case, and begins to run at the time EPA knew of the violations, is not dispositive of this Motion to Strike, it would significantly narrow the statute of limitations issues, and would provide t.hs rationale for the parties to seek extensive discovery regarding when EPA had knowledge of these violations. C. ResDondent’s Third Defense Is Frivolous nd Insufficient Ac A Matter of Lew nd Should 5 Stricken Respondent’s Third Defense reads, in relevant part, as follows: ‘Tremco . . . avers that the claims set forth in Counts 1 through 59 are barred by th• doctrines of laches, waiver and estoppel . It is a well settled principle of law that the doctrine of laches is no bar to a suit brought by the government to vindicate a public right . . . Cou ionwealth of Massachusetts v. Russell Stayer Cafl iM. 541 P. Supp. 143, 144 (D. Mass. 1982). ‘Laches is not a defense to an action filed within the applicable statute of limitations nor is It available against ths United States.’ US. v. Richard RePass , 688 F.2d 154, 158 (2nd Cir. 1982). Barring a showing of affirmative misconduct by the federal government, the doctrine of estoppel cannot be invoked against it and the United States is not subject to defense of laches in ------- —18— enforcing its rights. U.S. V. Ruby Co , 588 F.2d 697. 705 n. 10, cart denied, 422 U.S. 917 (1978). Complainant is seeking to enforce a public right and to protect the public’s interest through the enforcement of the environmental laws and regulations at issue in this case. There are two criteria for dismissal for laches: unreasonable delay in bringing, the suit and prejudice to the defendant caused by such delay. Baylor University Medical Center v. Heehler , 758 T.2d 1052, 1054 (5th dr. 1985). Carlson TV v. City of Marble , 612 F.Supp. 669, 672 (D.Ninn. 1985). Elements of ladies are full knowledge of the facts, unreasonable delay in assertion of available remedy, and intervening reliance by and prejudice to another. Thaco Coro. v Hodel , 611 F.Supp. 1130, 1208 (D.Colo. 1985). EPA’s Office of Toxic Substances had reason to know that. Tremco had violated TSCA on July 21. 1983. the date they received the cover memorandum which transmitted the three subject P? s. Complainant, however, did not become aware of this cover memo until late summer 1987. after an EPA inspector had randomly selected these PuNs for review, inspection, and validation. During the October 1987 inspection, the inspector was able to verify the existence of TSCA violations dating back to 1979. EPA concluded its investigation in the spring of 1988, after it had completed its discussions with Tremco and its receipt of the January 13, 1988, followup letter from Tremco, which provided the evidence to support the last two Counts of this Complaint. Complainant filed against Tremco le? s than six months after the inspection and followup had ------- —19— been completed, and believes that EPA did not unreasonably delay taking this action. Furthermore • Respondent has not demonstrated that it has been prejudiced as a result of Complainant’s filing on July 20, 1988. 9here are two (2) types of prejudice that will support a claim of lathes: (1) loss of evidence which would support defendant’s position and (2) change of position in a way that would not have occurred but for the delay. Rick v. Class , 643 S.W.2d 872. 877 (Mo.Ct. App. 1982). In this present action the Respondent has not been prejudiced by any possible delay. Respondent a iits in its Answer that they manufactured all three chemicals during the, time period alleged in the Complaint, and was able to provide in their answer more complete information regarding the violative production. thereby increasing the number of violative acts. Clearly, the Respondent has not loss any evidence regarding their manufacture of these chemicals. Clearly, under these facts, this Third Defense cannot survive. Accordingly. Respondent’s Third Defense should be stricken as frivolous and insufficient as a matter of law. D. R.g ondent’a fourth Defense Is Frivolous And Confuses The Issues In This Case And Should Ia Stricken Respondent’s Fourth Defense reads, in relevant part, as follows: ‘Tremco . . . avers that the total adjusted proposed penalty . . . is inconsistent with Agency policy and unreasonable in light, of the clrcumstRnces . . . ------- —20- Section 16 of TSCPI authorizes the Administrator of EPA to assess civil penalties for violations of TSCA. In September of 1980. EPA developed and published guidance in th Federal Register for the assessment of civil penalties for violations of TScA. 45 Fed. Req. 59770 (1980). Further in August of 1988, EP revised its TSCA S 5 penalty policy to, among other things, more completely incorporate the risk of hazard to human health and the environment as a distinguishing factor among violations. Clearly, the Respondent benefited from a revised penalty policy, for the proposed penalty in this action was reduced by 61.6% under the August 1988 policy. The proposed civil penalties are determined in two stages: 1) through the determination of the gravity based penalty; and 2) through adjustments to the gravity based penalty. The gravity based penalty is calculated based upon the nature, extent and circumstances of the violation. Upward and downward adjustments to the gravity based penalty are made upon consideration of culpability, history of violations, ability to pay, ability to continue in business and such other matters as justice may require. Complainant asserts that the civil penalty ass.ssed in the instant matter was calculated pursuant to Agency guidance. The gravity based penalty was based on the number and sizes of batch production information provided by the Respondent, was further adjusted for Respondent’s July 21, 1983, voluntary disclosure of the violations incorporated in Counts I through 57, and finally for the ------- —21— non-disclosed violations alleged in Counts 58 and 59, was adjusted upward for past history of violations. Tar these r.asons , Respondent’s Fourth Defense must be stricken from the Mswer as it is frivolous and it significantly confuses the issues in this case. IV. CON LUSION For the aforesaid reasons, Mi iraative Defenses 2. 3, and 4 should be stricken from Respondent’s Answer. Respectfully submitted, Dated : / &f/ ’f/” 1 Toxics Litigation Division Off ice of Enforcement and Compliance Mont taring ------- UNITED STATES JVIRONMU TAL PROTECTION AG JCY ORDER By Motion dated October 24, 1988, Complainant U.S. Environmental Protection Agency (EPA) moves for an Order to strike Affirmative Defenses 2, 3, and 4 from the Respondent’s Answer as immaterial, impertinent, frivolous, and/or insufficient as a matter of law. The Court being fully advised, It is ORDERED that the following matter be and is hereby stricken from the Answer: “Second Defense - Treinco incorporates by reference the admissions, avennents and denials set forth above and avers that the claims set forth in Counts I through 57 ar• barred by the appllcabl• statute of limitations. Thir(. Defense Trenco incorporates by reference the admissions, averments and denials set forth above and avers that the claims set forth in Counts 1 through 59 are barred by the doctrines of laches, waiver and estoppel. In the Matter of: ) ) TRDICO, INC. ) INCON DIVISION ) BMBOURVILLE, X TUCXY ) ) Respondent ) ) Docket No. TSCA-88-H-O5 ------- —2— Fourth Dsfens• — Treaco incorporates by reference the admissions averments and denials set forth above and avers that the total adjusted proposed penalty sought in the Amended Complaint is inconsistent with Agency policy and unreasonable in light of the circumstancss of tfls alleged violationa. Frank W. Vanderheyden Administrative Law Judge Dated: _______________ ------- C T1T1C T fl? S V1 I hereby Certify that the original of the foregoing Motion To Strike Affiraative Defenses and Neaorandia of Points and authorities In Support of Motion To Strike Affiraative Defenses and Order, Docket No. TSCA S$-H-OS, have been filed with Headquarters Hearing Clerk, and that copies were sent, registered ash, return receipt • or hand-delivered tez Honorable TraM V. Vanderbeyden Administrative Law Judge Office of the Administrative Law Judges (A-hO) U.S. Environmental Protection Agency 401 N Street, S.W. Washington, D.C. 20460 Stephen Q. Giblin Jones, Day. Reavis & Pogue North Point 901 Lakeside Avenue Cleveland, Ohio 44114 Respectfully submitted, / . I C ’ Dated: / Vincent Giordano, Esq. Toxics Litigation Division Office of Enforcement and Compliance Monitoring ------- w ------- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 0,, CONSENT AGREEMENT The United States Environmental Protection Agency (“EPA” or “the Agency”)- as Complainant, and Grifftex Chemicals, (“Grifftex” or “the Company”) as Respondent, the Parties herein, having consented to the entry of this Consent Agreement and Final Order before the taking of any testimony and without any adjudication of any issues of law or fact herein, agree to comply with the terms of this Consent Agreement and the attached Final Order. I. PRELIMINARY STATEMENT A. EPA initiated this proceeding for the assessment of a civil penalty pursuant to Section 16(a) of the Toxic Substances Control Act ( “TSCA” or “the Act” - 15 U.S.C. §2601 et ‘) by issuing an administrative Complaint arid Notice of Opportunity for Heax ing (“Complaint), dated and served upon Grifftex on May 25, 1988. The Complaint, incorporated herein by reference, states that Complainant has reason to believe that Grifftex failed to submit a timely notice of commencement (“NOC”) to the EPA on, or ) In the Matter of: - ) ) ) GRIFFTEX CHEMICALS, . Respondent ) ) ) ) ) Docket No. TSCA 88-H—03 CONSENT AGREEMENT AND FINAL ORDER 000001 ------- —2— no later than 30 calendar days after, the first date of manufacture of a new chemical substance, in violation of TSCA Sections 5 and 15, 15 U.S.C. H2604 and 2614, respectively. B. For purposes of this proceeding, without trial or other actual litigation of the issues or any adjudication of the facts, and in order to avoid disruption of orderly business activity and the expense of protracted and costly litigation, Grifftex (1) admits that EPA has jurisdiction over the subject matter alleged in the Complaint; (2) neither admits nor denies the findings of fact contained in the Complaint and this Consent Agreement; and (3) consents to the terms of this Consent Agreement and Final Order. C. EPA agrees to mitigate the civil penalty assessment, set forth in the Complaint, as described below. 0. The terms of this Consent Agreement and Final Order con- stitute a full settlement of the civil administrative action. E. Grifftex now waives its right to request a judicial or administrative hearing on any issue of law or fact set forth in the Complaint, including but not limited to its right under Section 16(a)(2)(A) of TSCA to request a hearing. F. Grtfftex certifies that, with respect to the violations alleged in this proceeding, the facility subject to this civil administrative action is now in full, compliance with the NOC requirements in 40 CFR §720.120. 000002 ------- —3— II. EPA FINDINGS OF FACT A. Paragraphs 1—7 of the Complaint are incorporated herein by referenceas findings of fact in this matter. B. Based upon inspection of Respondent’s records, and on review 01 information provided by Respondent subsequent to the filing of the Complaint, EPA has determined that the first commercial batch of Chemical A was manufactured on September 12. 1984, 1.2 days after the MOC was submitted to EPA. III. EPA CONCLUSIONS OF LAW The conduct described in Paragraph II. above, consisting of Grifftex’s failure to comply with the NOC requirements in 40 CFR 720.102, constitutes a violation of TSCA Sections 5 and 15(1)(C) for which a penalty may be assessed pursuant to TSCA Section 16(a). IV. CIVIL PENALTY A. Pursuant to EPA’S TSCA Section 5 Civil Penalty Policy, the Agency proposed in it. Complaint in this case a $10,000 civil penalty. B. Subsequent to the filing of the Complaint, EPA amended its TSCA Section 5 Civil Penalty Policy. In accordance with the amended Policy. bscause Respondent submitted its HOC Less than 30 days prior to manufacture, the Agency has reduced its initial penalty assessment to $2,000. C. For purpose. of settlement, EPA has reduced the civil penalty in this case by an additional 40% to 51,200. The 40% 000003 ------- —4- reduction includes; (1) a 15% reduction to reflect the cooperation and good faith shown by Grifftex in abating the violations all.eg in the Complaint and negotiating this Consent Agreement and (2) a 25% reduction to reflect the agreement by Grifftex in Paragraph V.B. of this Consent Agreement to undertake specific steps to ensure that all future NOCs are submitted in a timely manner. V. TERMS OF SETTLEMENT A. Grifftex agrees to the payment of a civil penalty in the sum of $1,200. Grifftex shall pay the civil penalty by forwarding a cashier’s or certified check within 30 days of the issuance of the Final Order, payable to the Treasurer of the United States of America in the amount of 51.200, to: U.S. Environmental Protection Agency Hearing Clerk P.O. Lock Box 360277M Pittsburgh, PA 15251 In addition, Grifftex shall forward a copy of the check to EPA to ensure a record of compliance with this Paragraph V.A. B. Grifftex agrees to provide notice in writing within 30 days of the issuance of the Final Order, to all personnel responsible for preparing and submitting NOCs, of the requirements in 40 CFR 720.102 for timely submission of NOCs. Such notice shall include an instruction to submit the NOCs only after the substances subject to the NOCe have actually been produced for non-exempt commercial purposes. In addition. Grifftex shall forward a copy of the notice to EPA to ensure a record of compliance with this Parapgraph V.B. ------- C. If Grifftex fails to pay the civil penalty in a timely manner as described in Paragraph V.A., or inform its personnel of the requirements for submission of timely NOCs and notify EPA thereof a described in Paragraph V.8., Grifftex shall include a stipulated penalty of $100 per calendar day, up to a total of $2,000. with the payment described in paragraph V.A., unless EPA in writing excuses or mitigates the stipulated penalty. D. The copies of the cashier’s or certified check and the written notice required to be transmitted to EPA pusuant to Paragraphs V.A. and V.B., respectively, shall be provided to the following person: Mr. Tony Ellis Case Development Officer United States Environmental Protection Agency Office of Compliance Monitoring Case Support Branch (EN—342) 401 N Street, S.W. Washington, D.C. 20460 VI. OTHER MATTERS A. Nothing in this Consent Agreement and Final Order shall relieve Grifftex of the duty to comply with all applicable provisions of TSCA and other environmental laws. B. This Consent Agreement shall be binding on all Parties to this action, their officers, directors, employees, successors, and assigns. Th. undersigned representative of each Party to this Consent Agreement certifies that he or she is fully authorized by the Party whom he or she represents to enter into the terms and bind that Party to it. o ô GO4 ------- —6— C. This Consent Agreement shall be binding upon the Parties and in full effect upon execution of the Final Order by the Adinini strator of EPA or his designated representative. D. Grifftex’s obligations under this Consent Agreement shall end when Grifftex has performed all of the terms of the Consent Agreement in accordance with the Final Order in this matter. E. Failure to pay the civil penalty in a timely manner pursuant to Paragraph V.A. may result in the forwarding of this action to the United States Department of Justice for collection of the amount due plus interest and stipulated penalties. 000006 ------- —7-. FOR COMPLAINANT: FOR RESPONDENT: Grifftex Chemicals Opelika, Alabama JON D SILBERMAN, Attorney Tox s Litigation Division Of fice of Enforcement and Compliance Monitoring U.S. Environmsntal Protection Agency Date: Q /i /fg *connie Musgrove, Chief Executive Officer (CEO) , of the Office of Compliance Monitoring, has redelegated the authority of the CEO to sign documents requiring the Compliance Division Director’s signature. * EN SHI dISHI. Direct Compliance Division Office of Compliance Monitoring Of f ice of Pesticides and Toxic Substances U.S. Environmental Protection Agency Date: BY % A1 & Q General Manager Date: cC L z :;Y. . FREDERICK F. STIEHL ‘ Associate Enforcement Counsel for Pesticides and Toxic Substances Office of Enforcement and Compliance Monitoring U.S. Environmental Protection Agency Date: Appr6 d ip legal form By: H. L. OODRI Associate Legal. Counsel West Point Pepperell P.O. Box 71 West Point, Georgia 31833 Date: September 12, 1988 I ( 000007 ------- I ) In the M atter of: ) ) ) GRIFFTEX CHEMICALS, Respondent ) ) ) ) ) I , Docket No. TSCA 88-H-03 FINAL ORDER FINAL ORDER Pursuant to Section 16(a)(2)(C) of the Toxic Substances Control Act (“TSCA” or “the Act” - 15 U.S.C. c2601 et eq). 15 U.S.C. 2615(a)(2)(C) , upon consideration of the foregoing Consent Agreement, the factors expressed in TSCA Section 16(a)(2) (B). 15 U.S.C. §2615(a)(2)(B), and the good faith and efforts exhibited by Respondent 1 it is hereby ORDERED: 1. Respondent Grifftex Chemicals shall comply with all of the terms of the Consent Agreement, incorporated herein by reference, and with the requirements set forth in TSCA and regulations promulgated thereund.r; 2. Respondent is assessed a civil penalty in the sum of One Thousand, Two Hundred Dollars ($1,200.00); 000008 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY - P C ,. ‘0 , ------- —2— 3. Respondent shall, within thirty (30) calendar days of receipt of this signed Consent Agreement and Final Order. forward a cashier’s or certified check, payable to the Treasurer of the United States of America, in the amount of $1,200. to. U.S. Environmental Protection Agency; Hearing Clerk: P.O. Lock Box 360277M; Pittsburgh. PA 15251, as described in the Consent Agreement. 4. Respondent shall provide written notice to its personnel of the notice of conunencement requirements in accordance with the terms of the Consent Agreement. Date: _______ __________ RONALD L. Mc LUM Chief Judicial Officer U.S. Environmental Protection Agency 000009 ------- CERTIFICATE OF SERVICE I do hereby certify that the foregoing “Consent Agreement and Final Order”, Docket No. TSCA-88-H-03, was filed with the Hearing Clerk and true and exact copies of the same were sent by Certified Mall, postage prepaid to respondent and by Interoff Ice to the complainant as listed below: H.L. Goodrich, Esq. Associate Legal Counsel West Point Pepperell P.O. Box 71 West Point, GA 31833 Jon D. Silberinan, Esq. Toxics Litigation Division (LE—134P) Office of Enforcement and Compliance Monitoring U.S. Environmental Protection Agency 401 M Street, S.W. Washington, D.C. 20460 Dated: October 5, 1988 U.S. Environmental Protection Agency 401 14 Street, S.W. Washington, D.C. 20460 000010 ------- BEFORE THE ADMINISTRATOR U.S. ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. In the Matter of: ) The McCloskey Corporatic-n Respondent ) ) ) CONSENT ORDER Pursuant to the terms of the attached Consent Agreement between the United States Environmental Protection Agency, as Complainant, and The McC .osk y Corporation, Philadelphia, Pennsylvania (“McCloskey” , as Respondent, which agreement is incorporated by refere!ce into this Consent Order, IT IS NOW, THEREFORE, ORDERED THAT: 1. McCloskey shall comply with all terms of the Consent Agreement. 2. A civil penalty of $615,650.00 shall be paid by McCloskey. 3. McCloskey shall, within sixty (60) calendar days of its receipt of this Order, forward a certified or cashier’s check, payable to the order of the “Treasurer of the United States of America,” in the amount of $615,650.00, to: U.S. EPA — Washington (Hearing Clerk) P.O. Box 360277M Pittsburgh, PA 15251 Docket No. TSCA-89-H-04 000011 ------- 2 4. Failure to remit the civil penalty in accordance with this order will constitute a breach of this order and will cause McCloskey to become subject to the stipulated penalty of one hundred dollars er diem immediately plus interest as allowed by law, and without further proceedings. Dated: MAR - - Ronald L. McCallum Chief Judicial Officer U.S. E,vironmental Protection Agen y Washington, DC 20460 000012 ------- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY BEFORE THE ADMINISTRATOR IN THE MATTER OF ) DOCKET NO. TSCA 89-H-04 ) THE MCCLOSKEY CORP. PHILADELPHIA, PENNSYLVANIA ) ) RESPONDENT ) CONSENT AGREEMENT The United States Environmental Protection Agency (“EPA” or “the Agency”) as Complainant, and The McCloskey Corp., Philadelphia, Pennsylvania (“McCloskey”) as Respondent, the Parties herein, wishing to settle all matters pertaining to this case and having •;on nted to the entry of this Consent Agreement 3nd Consent Orde . NOW, THEREFORE, before the taking of any testimony, without any adjudication of any issues of law or fact herein, and without admission of violation of law or regulation by McCloskey, the Parties agree to comply with the terms of this Consent Agreement and the attached Consent Order. I. PRELIMINARY STATEMENT EPA initiated this proceeding for the assessment of a civil penalty pursuant to Section 15 of the Toxic Substances Control Act (“TSCA”, 15 U.S.C. § 2601 g.) by issuing an administrative Complaint and Notice of Opportunity for Hearing, dated and served upon Respondent on February 16, 1989. ------- —2— A. The Complaint stated that Complainant has reason to believe that McCloskey violated TSCA § 5(a)(l), 15 U.S.C. § 2604(a)(l), by manufacturing twenty-six chemical substances (because the name of the cherticals were submitted as confidential business information, the chemicals which are the subject of this proceec.ing are hereinafter designated as Chemicals 1 through 26) prior to submitting a premanufacture notification; TSCA § 15(l)(B) by manufacturing twenty-six chemical substances which di f not appear on the list of chemical substances maintained by thc Administrator pursuant to TSCA § 8, 15 U.S.C. § 2607; and T;CA § 15(3)(B) by failing to submit reports required by TS A prior to the manufacture of these substances. B. This Consent Agreement and Consent Order shall be a complete settlement of all civil and administrative claims and causes of action which arose or could have arisen under TSCA in connection with the production of Chemicals 1 through 26 by McCloskey. C. McCloskey certifies that it has filed a premanufacture notice with EPA for Chemicals 1 through 26 and that the notice review period has expired. D. For purposes of this proceeding, without trial or other litigation or admission of the issues or any adjudication or admission of the facts, McCloskey admits that EPA has jurisdiction over the subject matters alleged in the Complaint. t. 4 ------- —3— E. McCloskey now waives its right to request a judicial or administrative hearing on any issue of law or fact set forth in the Complaint, including but not limited to its right under TSCA § l6(a)(2)(A) to request a hearing. U. EPA ALLELATIQNS OF FACT On August 21, 1987, Respcndent provided information to EPA which indicated that Respondent had manufactured Chemicals 1 through 26 on multiple occasions prior to the date these chemicals appeared on the TSCA Inventory of Existing Chemical Substances maintained by the AdmLnis rator pursuant to TSCA § 8, 15 U.S.C. § 2607. As a result r.f receiving this information from McCloskey and of reviewin] Respondent’s records, EPA alleged in its Complaint that t4cClbs]cey violated the provisions of TSCA inasmuch as Respondent: 1. violated TSCA § 5(a)(1), 15 U.S.C. § 2604(a)(1), which states that no person may manufacture a new chemical substance without submitting a notice to the Administrator of EPA at least ninety (90) days before manufacturing such substance; 2. violated TSCA § 15(1)(B), 15 U.S.C. § 2614(1)(B), which states that it is unlawful for any person to fail to comply with any require ont prescribed by TSCA § 5; and 3. violated TSCA § 15(3)(B), 15 U.S.C. § 2614(3)(B), which states that it is unlawful for any person to fail to submit reports required by TSCA. 0 ‘0O;15 ------- —4— III. EPA ALLEGATIONS OF LAW EPA alleged in its complaint that the conduct described in Section II above constituted violations of TSCA § 5(a)(l), 15(l)(B), and 15(3)(B), f or which a civil penalty may be assessed against McCloskey. IV. CIVIL PENALTY Pursuant to TSCA § 16(a), the EPA TSCA § 5 civil penalty policy, and based upon the facts alleged in the Complaint, EPA proposed a gravity-based civil penalty of $2 .706,000. Because McCloskey voluntarily disclosed to EPA t; e violations alleged in the Complaint, the proposed penalty wa jt sted downward twenty-five percent for these violatio,s. Further, since McCloskey’s disclosure was conducted in a timely fashion, the proposed penalty was adjusted downward an additional twenty— five percent. The final adjusted proposed penalty provided in the complaint was $1,353,000. EPA further reduced the penalty by fifteen percent after McCloskey provided EPA with infor ation which documents that McCloskey took all steps reasonably expected to mitigate the violations, once McCloskey discovered these violations during an internal audit of company records. Finally, in consideration of the Environmentally Beneficial Expenditures which McCloskey has made and ias agreed to make, EPA is exercising its discretion under the penalty policy and has adjusted the proposed civil penalty downward an additional twelve percent. 000016 ------- —5— Therefore, EPA has adjusted the proposed civil penalty downward by seventy seven percent. These downward adjustments result in a final adjusted civil penalty of $615,650. V. TERMS OF SETTLEMENT In order to ensure future compliance with •.he Toxic Substances Control Act, the following actions have been and/or will be taken by McCloskey. A. Environmental Audit McCloskey Corporation represents and certifies that it has spent approximately $400,000 to conduct an exten3ive internal audit of the TSCA compliance status of its threc manufacturing facilities and corporate headquarters. These eozts include laboratory analyses of McCloskey’s raw chemical substances and final products, and the expenditures of corporate management resources to fully investigate TSCA compliance issues. The audit was completed in August, 1987, and identified a list of 26 chemical substances which were either not on the Public TSCA Inventory or for which McCloskey PMN documentation could not be found. It is this Audit which led to the Company’s prompt disclosure to EPA that a potential TSCA compliance problem existed. B. TSCA Com 1iance Plan McCloskey has developed a corporate TSCA Compliance Plan for the manufacture and distribution in commerce of chemical substances. McC-loskey represents and certifies that it has spent approximately $364,000 to prepare and implement this 000017 ------- —6— compliance plan. Expenditures include: developing a computer program which will allow McCloskey to integrate all batch creation and sales activities in a manner that will preclude the manufacture of a chemical substance which is not on the TSCA Inventory, and fees to outside consultants for their ad’ ice and counsel in addressing TSCA compliance concerns and formUating this compliance program. C. Publications in Trade Journals McCloskey will submit an article on TSCA compliance to three separate trade journals for the paint and coatings industry. The article will be authored or co-authored b Mr. Robert Katherine, Chairman of The McCloskey Corporatior.. McC].oskey will submit to EPA, for its review and comment, no later than 60 days after the effective date of the Consent Order, a draft of the article to be published in these trade journals, and a list of the trade journals. Upon completion of EPA’S review, McCloskey will submit the article for publication no later than 30 days after EPA has returned the article to McCloskey. Within 30 days following publication of the article, McCloskey will submit a copy of the published article to EPA. D. EP A Compliance Seminar for Customers McCloskey Corporation will conduct a compliance seminar for its customers on the statutory and regulatory responsibilities of users and processors of chemicals subject to Section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA). McCloskey will complete this compliance seminar on 000018 ------- —7— EPCRA § 313 no later than 180 days after the effective date of the Consent Order in this matter. McCloskey will submit to EPA, for its review and comment, a detailed agenda for the upcoming seminar no later than 60 days following the effective date of the Consent Order in this matter. No later than 30 days following completion of this seminar, McCloskey will certify to EPA the completion of this seminar. E. Notice All reports and submissions required to be made to EPA by McCloskey under paragraphs C & D above shall be sent to: U.S. Environmental Protection Agency John Foley (EN-342) 401 M. Street S.W. Washington, D.C. 20460 F. Civil Penalty In consideration of the aforementioned Terms of Settlement, the Parties agree to a settlement consisting of the payment of a civil penalty in the amount of $615,650. Payment is to be made by McCloskey by mailing a certified or cashier’s check within sixty (60) days of its receipt of the executed Consent Order, made payable to the “Treasurer of the United States of America” to: U.S. Environmental Protection Agency Hearing Clerk P. 0. Box 360277M Pittsburgh, PA 15251 9 ------- —8— VI. STIPULATED PENALTIES If any of the following events occur, McCloskey Corporation shall pay a stipulated penalty in the amount prescribed below for each event, unless McCloskey’s failure to perform the action in question was the result of persons or events beyond the reasonable control of McCloskey, and McCloskey provides notice of an expected delay at least 3 working days prior to the date performance is required, unless 3 working days advance notice is not practicable under the circumstances, in which case McCloskey shall provide such advance notice as is practicable under the circumstances. McCloskey’s notice shall include an explanation of the steps taken to avoid the delay and a new schedule for performing. The revised schedule must be approved by EPA in writing: 1. failure to submit to EPA, for review, the draft article within the time period specified in Paragraph V, Section C above: $200 for each calendar day that submission of the draft article is late. 2. failure to sub iit the article to the appropriate trade journals within the time period specified in Paragraph V, Section C above: $500 for each month that submission of the article is late. 3. failure to submit to EPA, for review, the agenda of the EPCRA § 313 seminar for McCloskey customers within the time period specified in Paragraph V , Section D above: $200 for each calendar day that the agenda is late. 000020 ------- —9— 4. failure to conduct the EPCRA § 313 seminar for McCloskey customers within the tine period specified in Paragraph V, Section D above: $250 for each calendar day that the seminar is late. 5. failure to certify to EPA that the EPCRA § 313 seminar for McCloskey customers was conducted within the time period specified in Paragraph V, Section D above: $200 for each calendar day that the certification is late. 6. failure to remit the civil penalty as agreed to herein: an additional stipulated penalty of $100.00 er diem in addition to interest as allowed by law. 7. Failure to remit the civil payment will result in this matter being forwarded to the U.S. Department of Justice for collection and all other remedies available at law. VII. OTHER MATTERS A. McCloskey has submitted evidence acceptable to EPA that Chemicals 1 through 26 have completed PMN review and so certifies by the signing of this Consent Agreement. B. Nothing in this Consent Agreement and Consent Order shall reliev licCioskey from complying with all applicable TSCA regulations .r other applicable environmental statutes. C. This Consent Agreement shall be binding upon the Parties and in full effect upon the signing of the Consent Order by Chief Judicial Officer or his designated representative. 000021’ ------- —10— D. McCloskey’s obligations under this Consent Agreement shall end when it has paid the civil penalty in accordance with the Consent Order, and has completed the items specified in Paragraph V, Sections C and D. E. All of the terms and conditions of this Consent Agreement together comprise one agreement, and each of the terms and conditions is in consideration for all of the other terms and conditions. In the event that this Consent Agreement (or one or more of its terms and conditions) is held invalid, or is not executed by all of the signatory parties in identical form, or is not approved in such identical form by EPA ’s Chief Judicial Officer or his designated representative, then the entire Consent Agreement shall be null and void. 000022 ------- —11— WE AGREE TO THIS: For Complainant: Michael F. Wood, Director Compliance Division Office of Compliance Monitoring 4 i—’ / (/ v2a’ ’ - ‘- ‘ ‘fl Vr cent J. Giordano, Esq. Tox.cs Litigation Division I _1 Frederick F. Stiehi Associate Enforcement Counsel for Pesticides and Toxic Substances For Respondent: The McCloskey Corporation D vid J. Ha es, Counsel to The Mc 1oskey Corp. Hogan & Hartson 555 Thirteenth St., N.W. Washington, D.C. 20004 Edward E. Reich, Acting Assistant Administrator for Enforcement and Compliance Monitoring Robert Katherine 000023 ------- CERTIFICATE OF SERVICE I hereby certify that copies of the foregoing Consent Order in the matter of The McCloskey Corporation, Docket No. TSCA-89-H- 04, were sent to the following in the manner indicated: Certified Mail, Robert A. Katherine Return Receipt Requested: Chairman The McC]oskey Corporation 7600 State Road Philadelphia, P1. 19136 First Class Mail, David J. Hayes Postage Prepaid: Hogan & Hartson 555 Thirteenth Street, NW Washington, DC 20004 ay Hand-delivery: Vincent Giordano, Attorney Toxics Litigation Division (LE— 134 P) Office of Enforcement & Compliance Monitoring U. S. EPA, Headq art :rs Bessie Hanimiel Headquarters HEaring Clerk U.S. EPA, Headquarters Dated:M,4R -7 198 Brenda H. Selden, Secretary to the Chief Judicial Officer 000024 ------- T I - I C ft McCloskEv ‘ CORPORATION Manufacturers of Alkyd Resins • Varn shes • Erni:Is ,ors • Sea’e s anc Natural Wood Fn’sries . 1 1 — - 2 _‘“E-tD A - - .t. _-. - - -:z$. - LY I. ;- 1 ’’ •_-: -:..i!i:g- r M- i— I r_ .r:xtc t.IflLT ’;_5 :c. -r_c :‘- : ‘ !I.DL’ST- - ‘. THE E .ETTE c -c T.—5 f- if r. 1 : .ZPF THE :_ONc ° - -7’ RE’2UE ’ ED -f CnJR C ::FNr tJRPEP E r’ —: 3 --- - , c 9---:7 EC-’ . - I ‘E HA E N’JT HEAflD -R3M r-a OT’ E-4 r-L: - ErIERS 1EI( EuBMI T TEZ NE (4R E ( S OF -I. :-A t E. •:‘. i- vE -i ’ PUEST ONS R I E SE r, LL ME A T ?: - : - 3’.r’. E IFcCFRELY. ‘ -/ c c4 ‘ GC 1 RY A - i LE.F it: D,ZV’D C.RflDV CSO IICGAN ‘Zt.D H PT L’i\ ROY Lr P1F3ERLI’J VALSPAP 000025 ------- 000026 The ::l : vi V r.i ’a ’ whea to :‘ca. .1 ‘ 11 :a Lt tZ S :e’ t r 1 :Je ,ir:c t’ A:ld : ;.ir L.lfl t tJL .i’r% ...L ’. t \ti1t m .irc • :...‘ streai. t(’. ()ntJ’ : Je1Re ed ‘n \l tr. \::er. : it i ‘izraph’ .L’ I .: a.it .i\” .ur ‘ t i S MILTON CAN COMPANY, INC. Don’t expect- this can to return. bc ’. e tgneJ b :.:c r not to e of superiOr tce: .zh :ee. it t’: h ’a Ie f t r x:—i Re u t rou !‘.C JI’S th.it ...a : . .r.t T : rrcre L . ’ )k :o .i tai. ‘:: :.n — .irt j ..i JJ . ..tgur.lt Cn .i a:n’: h:ing ii..r Ii Circie S on Reader AcItor Card I .)fl-LjtY-( S ------- - . — j Contents News May was good for architecturals Paint shipments were up across-the-board year-to-date flat I Construction outlook improves J Dodge predicts boost due to dechning mortgage rates McGrenera heads Chicago PCA Northern I l linois Li S attorney speaks at annual meeting Huber s CDtC society president Members are conducted on tour of Navistar truck facility t-1oward G Sholl dead Was 1958-59 Federation past president. 50-year member SOCMA announces officers New board members chosen at Tampa Annual Meeting Technical Somerville talks to Baltimore SCT fresents reporl on Technical Committee dispersion project Features Compliance with the Toxic Substances Control Act in the coatings industry By Robert A Katherine and Gary A Wetp CMA referral service answers public concerns about chemicals Departments The Markets - EB and phthaluc drop Technology On-Line Coming Events Obituaries Financial Front Editorial The power of creativity New Products Opportunities (Classifued Advertisers Index O ICRiCAN PAINT 6 COATINGS JOURNAL 1 ISSN CC565430) Is pu0i.0 5 00 *eeUy #IC6TI f. e Conneniw DaIly .Itues 7L7 1shAd A O l 5 Aurleg conne 5or 0’ 5 S 00 Tel A6 by Anrercas Palni Journal Co 291 i Wasilaglan Ave Si LAwS MO 63i03 Seconti : 1050 505iate ao or Si LOInS ‘ . 10 POSTMASTER Se ’a adAress c 3’qis is AMERICUA POiNT 6 COATINGS JOURNAL 29 1I Waohnglcn A.e Si Lou’s vO n3 103 PuOlcailon E IecuI,ve Earcrai use SubsCIIOion oRes 2Si I WaslOnqion Aue Si Lou I ‘.10 63103 F”on, i314 1 531 0301 niec ,n US il—’encao P ni Jour,ai Cu An in000Andeni Nilto ’aI Aeeki 5 Anna 1 wo. • n unaca Slabs 52530 Caaoa 6 Meoco 5A1 u 3 E.sennete 15230 Ogle copes Unied Siaiei 5I 60 EIwwIILe S2IO Ccv DolOd aides :Clrrlu iI_ .I 6 ’ S AC till TOIlI055I 5u: C,$ .510 50 1CC mA’ 7uOlv .3bI ’fl v 7InAIA 000Sni 1CC0 5 51 1I, pI, ei:C ’•A C r uia ’v n .I Ifl9 0.101 CO 11.096 .550 C :1 1.69 reun ,In .’acIueIS .500 IflAd eraIiayens 7 9 15 17 33 47 11 40 44 23 27 31 33 35 39 55 58 62 i v . - “II Ate ‘I. Membel SCHOLD MACHINE MIDWEST Dl’ ORIGINATORS OF TI! 2Ot WEST 64th PLACE CHICAGO. PU 312/458-3788 3U Sales & Technical Hoc 1. Oi’PORATE HEADQUARTERS SOL.THERN DIVISION ( 139J Osk Street N Si Pelurubuep Fl . 33716 M1J ‘70.1147 vi ;9i8o6 FA To our customers and fr Thank you very much. \ our 40th year and runni We could not have mac considerable trust and s’ Thank you one and all it possible. Sincerely, The Folks at Schold Ma Midwest & Southern Di Circle 8 on Reader OQOO Monday July 31, 1909 .1 Vol. 74, No. 3 •scl ------- I MM,INE YOURSELF attending your lirsi toiilpafly lx)Jrd ol directors ullectitig. liioscvcr snu are there to e’pI ni a si in II I ni I tue t the hi a rd after t lie I l’A I us tu’iidticted an audit of sour oiIIpaily and lound that ou arc not in conii,Itaitce with the Fouc Substances (ontrol Act TS( Al \ our dreams hasc turned into a nightmare II that sounds lrcpusterotis. this article is csscuiti.tI rcadiiig br you and the scitior unauiageiiieilt ol your cOmpanY Ask your self. “Is lily COiiiIldllY lit cOtiil)IIaIiCe with the 1 oxie Substance ( ontrol Act” II your corn paiiy niauittlact tires paint produus, you probably think ihat you arc exempt because you inaiiulaciurc only nhixtures II your cotnph.inee program stops there. yu tu arc aliiiost sit rely 0111 iii comphancc wit Ii I S( A. and it is Iiilpet.ttiVC (1181 OLi lcaiii more ahoul TS( A .tiid the regulations that the Ll’A uses to inplcuient the Act Alter doing so. you must write and implement an effective TS( A compliance program for your cornp.iiiy Ivery company in the coat iiigs niaiiulactui ing iildustry must have such .1 LtIiIii ’li.tIii..C uiigr.tiii iii ,i uiiil ‘ e%ti. is.ii.il lit’s tiI.iii(l.iIC(l hs the siaIiuic .tuRl icgiiI.iuii ii In liii iiittl.ilitig CoiilIllLtil .c I l.lii, kccp iii iiiiIiLI ili.tt sshile the Iat.t hut uir eiiiiipan ‘‘tily iii,iiiuilaettircs illixI Iii CS iil8 esenilit yini lioni liavitig to Ide prein.iiiiil .icIttit’ 01)1 ices, all ot Ret sect iouis 1)1 II Ic i cgt I kit KM iS still apply In our coiiiiuny —l In is. viii t mns l heconic aware of the otlicr iiiajor cecinuis such as section 4 test rules. section 6 reguLi lion (it custtiig CiieiiiILilS. scet ion 8 recoi ti ket’piiig .inil ieporliiig. cetiniul I 3 regukilion uI Uieiiiiuil intpoi ts. and uitlicr parts of sec- tion 5 oil new chemical regulation The following briel overview tif tIi icgiilatioiis is a s.iinpling ol the issues that your coni pliance progiani must address. ou should constilt the regulations tlicrnsclvcs for the details on how to implement the progiamc siiuiiiii.ii tied tn the overview • Aity company intending 10 manufacture or import a new chemical substance lutist filc a iircrnanufacturc notification (PMN) 90 djys pi or to niaiitifacture under ‘l’S(’A sec 111)11 5 ‘I his requirement ciialilcs Ll’A to screen a new chemical before its conuner- cial productioii or irnporlatioii lii general terms, if tile EPA Finds that the new cheiiiical may present au unreasonable risk of injury to health or the environment. or that it will he produced and rna enter the environment in substantial quantities or there may he significant or substantial human exposure to it, and if there is insuf fietciit information to permit a reasoned evaluation of the effects of the chemical substance, the EPA can restrict or prohibit its rnaiuufacture, processing, distribution in commerce. use or disposal Thesc orders may restrict your use of a new chemical sub’ stance Once a chemical undergoes PMN review, the LPA places it on the TSCA Chci iiical Substance Invenlory. The I MN rule does not apply to mixtures: this exemption applies to most paint prod- ucts Keep in mind, however, that thc com• poncnts of the mixture must all be in the TSCA (‘liemical Substance Inventory for the exemption to be valid, and the mixture must nieet the TSCA definition of a uiiixttirc ‘lien a tluetiuitji stillst,t net ii br liii’ lust nine iii .i new use •i ct it i tl h the I PA iii a siguuilttaiit nest use i tile (or “SN I. Ut there is .1 rc(l tiiicitlclit ilt.it the I l’. hi’ i’ivcn 9(1 dats not iie Rehire I hat clii i,iic,il substance L3n he used. CS Cii iii lie ili nii ,il is in the ins cntor or has tussed through the [ ‘MN process hoc .iiiotlicr use oti iiiay huasc 11181 “significant new usc hut den as a coiiip.inv tli.ut processes that chem uc i I in to .i nit siti rc I or t’ .i ,nplc, one .. hen iii .it widel v ticed iii t he coatings in dustry, iiicth iii hut yt kctoiie, is suilijeci to a “significant iicw use” rttle. with “an use” triggering the SNL t K rcquirctneuits ‘I SCA sCetiun 5 also sets dowiu rules ap- plicable to R&l) on new chemical stiR- ctances’An exemption from the PMN rc (lutrcnicntc exists for R& I) chenitcat substances ii the work su tth those suihst.inucs is supervised by a “technically qualified in dtvidual” and the rnanufacturei has cvalutatcd any lX)teiitiah risks associated with the R& I) substance, notified the persons ondiietiuig the R&D oh those risks, and maiuitained certain recoi ds as to the R& I) activity Mdiiul.tciLiicis ,IIC rctltuiie(l Iii notils ails pa it to win ,mn the K & I) sLihstj nec is ii is ii ihti ted that t he substa iii e is an K & I ) stiR staiiee onl . and 1 jinvide theni ss idi tile risk eva Iua Iii iii resti its, t lie v slunt Id .t 1st, iiil unit tic users 1)1 t hcui i cs it incihil ii cs u iidcr ‘I S(A .tiid of 1 SI A .upprosed dtspos l methods br residuals Uscus of ;tii R&D sub stance should not allow the substance to enter conumeice until the PM N pci io U is complete for the substauiuc’. and then must follow any restrictions on the use of the cub stance imposed by tile I ,PA 1 his process may take sonic time, so all parties must hate patience while it is Lt)itilllctetl •l’SC’A section 4 in getieral icrtus. author i/cs the l:PA to require test ing of chemical stib,stances and mixtures if the L PA finds that they “may present an Ltnrcasonahle risk of injury to health or the ciuvutunnieni or if they will he produied iii stibstaittial quan lilies that result in significant csposure l:t r exanitile, the El’ is currently pre ill ‘hnii ’su a’, Pu,,,! i( ( ,,ai,,ns J , ,u,,,uI in!, 3!. lv.’ v A; oooo 41 Compliance with the Toxic Substances Control Act in the coatings industry By Robert A. Katherine and Gary A. Weip Robert ‘I Fsai!ieruse ias pr’s,du’ni wul liatrinari ciii! .4 ii 0 ( 1% t Ice pretulent tec’hnit ci i / he Mc C’loskes (‘orp. Philadelphia Stare the article ii as ItrIllen. McC’loskey tsas pureha.sed h) 1 lie I ‘a!spar Corp. Min ti i’i polic ------- b.Z,4flJQL) .1 It ‘I I ii i ’ liii iii_ l ii ’ . I i ii ’ I It i i .Iullt .iili..t.ijitt i iiitiiiiiitll. •l’.i . 1 .1% .111 .11111 skiut i i i ii i ) uiuir I lit I 1 \ 111.1% tiii’uiutil itt . 1 1 111.11 I. ‘I I lit liii I lit .i il’51.Iilt 1 111111 t.Iil i(2( Iiiut IIll l I l l t4 1i 1 1i1 1t I i ( 2 .IiiI!I III tiiuuIIil ’tlIt iu I’.t.iid% It.’.luiiU ti lsis ii lilt tt’sl lIIt it stilts ‘.ii..tt 11 1. 11 .111 liIiit.isI)Ii.ii)it. tick ‘ II iliflir ’ . iii ilt.iiliI ill the cut lii lliiilt’Itl is st IlItti l It hit siii ’sI.iiice lilt I I ’’ . .I.ilIIllhIs 1 1. 1 1 1 1 1 t.iii tilhilil iS( \ st i hut I . luuIliluilll ‘ Ii 1111111 • Itilut II I it •ilitiii Ii Iuil ll 1 St 1.11)1. iiiit ‘ ii 1 1111(21 it 1 1 11114 1 1 1t h t ’ \S .1 lil.iIIIli .ltItIiLl .1 PIt itt.’ 1 ‘.1)11 iitli’l 1114)1)111 )1 tile / r(I(’li!I i ’.eI%IiP l iii lIt’. ’ . lest i iuies. (or .lilil() 1 1 114c’ Ihi tull stlil lilt itSlIiis I II the les ls .ihltl .11 1% te ‘II It 11111)5 111.11 111.1% he Ilillilist ti tIll %lHhl tutu P .11 1% ‘ INC uI . 1 I. i1tiiIlt.Ii slil)SI.lilLe i l l tulflIl’ielllCill lilt I l’ ‘ ili (i.tIj tcgtii.i 1141% .411111111 it’. tiilti I tile ( Ililel setli()lIs til I \ ‘t’tII°il S l. ties 1111 IetI’rtikeeplilg .uiuti i i . Illihlut I ! ! 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ClIt Iiluiiilittll Set liiut iltll letillIles iuiilllIl.It.l lilt I ’ l i i 11141% lIlt lusts .111(1 Ll)lIlt”. iii ilt.iitii . 1 1t h ‘.Iltlt 5 1 1 11 1 1 Cc 11 1. 11 .111.’ I)tIilulliICti 1 11 ( 1 1. 1 Set 11 1 111 il,ii ‘ .4111 111.15 he lCl(tli1t li I I) LI Ilifl hlCit .1 i1reiiIulIlI.lr .issessIiIelli 1111111 111.1 hull rule ti’ \ 11(1 t 1 llcstl(Ilill 1 llrC III .1 t(Iill C iitllSl%t’ .isSt’ sSlliCllt iIlh)lili.ltll III I (lit’ l( 1 S.i 1 (1 (11115111 itiit.Iirc it i t ilt’hllII.liS Vufti ill.IlilIi.ut. 1111(2 iillpi lrl ur I i i tue t..lse iii ‘\Iit. lilt) LI I itese rllies .11(2 ihell1 phtlillliiglteII 11)11 ‘1111111% uitereicire. ‘.4)11 1111151 t’..lhi.ii it’r 11142111 iii the / ri/era! Ret.’s’.irr .111(1 respu lilt 1 ‘.t iteit ‘.ullur toi lipallS is retitiireil I I ) 1(211(111 Stttloll I 3. iii geliei.ii teritis piuiiiiiiits tilt’ 1 11 1 1 k ff1 .1114111 til the I ) ) lcai s iint.ii it. cc lii ilest I ke iiiipulrter ce,1I115 tli.tI t ue stIihsl.liitt’ iii fltit’sl II II) is Ill L(lll)Ihil.lhltC ‘.‘. itli I S( ,\ I iii ’ . .iS(Vt I ( Ii I SC ,\ lt’%lM lIlSil)iillhes IS 4)11(21111% I’i ili(ikt (i ‘.‘. iiii 1 llIlt’ilil.iii% serlttlis rcstiils i ii Itliui’. i ll till.. liii t’t.iliih’it hil l. lilit IllIltI lt’t tiili% 11.1 111 .1 “I I iIiliiIluIl 11 ( 211.111’. lui liii I i’ t \ iu ut ‘..ii 111115 Ill)h)Ilit lti,itttI Vil)I.ltl(lilS t,i I St \ lil’.hui’.ii12 ii tlitlliit.liS lie tthlllI)lui% 111111.11 Itti 1(11 list’ Ill its uti.iiitii.ithtii iiig 1)14) Less A 111 )111(21 Ite) .iic’.i 01 regui.tl tat uittiei I S( A is t ue i ccli IL. ! Hills Oh) PO 1 YL lilt )rliia te d l)1 1)iIClit is ti’( its! It4ally dclii ui,ti COtit(ft) iieills slit ii .1 ’ . Il.lllslliiillehs .111( 1 L,til.lt 111)1 5. ‘.tlihtil .iIt ttlliiillullli) iiitiiiti ill 1 1. 11 )1 1 IIi.iiiIs. tulill ,Illl P( us \ ‘liii I l)IiIi)ii.Illt.e )it) l . 1111 l u lls! en Ver (lie PC lIt tiles. w ll lt h are among lie 1 11 ( 15 1 LIII 1)1 11411 11 )’ Vi i )iJItd I ego LI Ilt)i)5 Ii lltlt’I I S( ‘ s It wi.i v I ite it)siu. Sliih’.tilttt5 C 4)1)111)1 Act t i ll) 1.1111% spt’t lilt Li I lglI.lge I egi rti I li proii iiii led .ltl\. tiieim ,hIleluIi.liil civil .11141 crllulih)zui iitiiaii lies as ‘.‘.eii . 15 tile liii lstlIt.tl()Il oi tite distilL.! tOllil lot spetiiit eiIil)ltt’llIt’u1l Ml)IieUIi ‘. peii.uiiies l.,I1i icitli 25 (h ill) (1(2 ! (i.iy 1\lu eiit’ulive I St ,\ t llilll)li.lllle piogi.iiii is the ( 1111% ‘.V.iS Il l .l’.’olti t ue stteie iuelhlithes luau (1.11(2 11 ii ’ . t ue lt’IIui.ltI(.tll’ I it’llltiihs i i i .111 tIlt_u. Il’.t tttuiillil.lhiLe 111( 1 ‘lIlt tilt link I A 1(11111)111%’ IN tilL S tittI cie.triy states I he In.tlu;Igeh llel Its 11111 III 11)11111 (24 )ll)i)iy WI iii t he I utsut. Solist,iiites (1)1111111 ,\t I 2 Naiiitiur . 1 ttllllI)liiS ttiiiti.il .15 (l Ie t )lIt P . 11 1 5 % I St A tIliiiI)IIllite u)hilit’t su. tilt St ‘ s LI 11111)1 1.11 Il_C 11.111 (Ii ills 4ff 11(21 JIll) tlest.h 1(111(11) .uiicl leglli.ir 111111(25 I A i llultetiliies ili.lllli,il di.tt g(iltles yntir (21111)14 ‘tees thiun I!lu I. c L I lt.u I ii ivtilve I SC A It lii 11 )11 .11 n.e St It. ii is a lrt tti.ii Ill . 1 flew raW uh laler ldi. lt& 1)1)1 a hlet v product uiiattulae 1 11 w u ul . 1 11 ( 2%’. iiltXiuLI. .lllti recordkee(uhig br 1 111 ttl Itt 11 1)11 I iea ill ) elicits .i ilegzt Ihlilis. a lid 11111cr IMhrilusCs 4 All ( 211 15 ) 14) ’ . cc II 111 11 ig l nIgr.u Iii based uiii Ike h liotetkihes 111.11 ire eslZhlhiisiled S A raw I Ud IcrIal list Ilia I I liciikle% Ii IC t ilellultal i laiuue til (lie llI.Itei uul 81 1 (1 Its Chletil tal ;ihsti.tt I services ntlnlher. tw. ihi tile case oi lii IX Ill res or ( W I plle I.i ry it InuposlI 1 1)1 IS. 1 ten I Ile.l 111111 11(11)) I lie IlkIli lhidel t iret t h a I I lie lllalerl.ll lul l 115 ctuhl(suneuts In I lie case ui Ilt l stl ire l is Ilstttl Ill Ihie I St At Itellllezli ‘Stub sI.hiice iuut’einors lu ‘¼ lush i i i I I lu(htit l 1 11.11 .1 1 1 I II ’ lilt ii’. ii’.Itsi .it hit 1St ‘¼ 1 iii 1111 1.11 StilIsl.ilIt ts liu ‘.4.111111% 141 III hile t.ist uhi . 1 ill lslulut lilt tullIllItliltill . uul lIlt illIslilIt iii,ut .111 . III lilt’ IlittlilI li t I )uih’. iiiiitiiit I lull lilt III 1111% ilt iiialillh.Ittllleth u ll ‘.41111 7 SIih l’. 1l91l1 1)it 1 , 11 5 (1’. I .. 111.11 hllutlilIulls tite / ui/t i l l! !?rt,’,’.I’, ti , I St ‘¼ iel,uteti 11 1.11 1 5 5( 11_It .ls esIshilig tl lelulut.Ils 11 1. 11 ‘.‘. ill 1e stili It’L I It I teclilug I II i l’s lit Ill ( A lit 111101 111.1 114111 111.11 31)1) 11111.1 1(2111111 \ tuii 111.1’. iisut ‘.t.iiul It) u_OhlI,ILI the I 15 ’ s s I S( i ’ s liitltlsli % Assistaiiu.e ( )hln.e. h:’lIll I Sill. .tiiutuiI stihi scriiitiig to tile I PA’s ‘C luellultais Ill) Ite lkilt lug Roles ccl tile ttiiit_ii iiitieses clIelIlILlis s(hilIttl i i ) V.111(t Ils 1St i ’ s lethllIheIllelits H Sitiiscriptutui to the I PA iu.ulhiilg list itui lilt’” 1St A C Ilellilculs iui i’iuiguess i lllhietimi.’ whit hi Is I1(li lhlSltCIi i i’. lile I PA C )lhlLc tul ‘I ‘ sic Stihsi.iuuces •illti ‘.t lIlt II 1)11)’. ides use luil iil)Ii.hlt_L 1111 tue 1St A lLgtll.hhtnv ,ittItll II suitii tuuiiip.iii’. 11.15 I I I ’ boilIi.11 I St. A tAtIlipII,hliLe i)ru l l.lIli lilt) ‘.4)11 1111151 tieteltip 1 ) 1 k’ 1111%’. lilt. ‘ Itt ). li i hu,hhunt tic I I 11 111 11 1 t tli lles Ill lilt i.i’.’.’ iuitl tilt’ lt::li 1. 11 1 1 Ills ,ilhui .1 511li)iie,itIIluu lhi,it esihi.illi5 1 1 1(21 11 2 ‘.Iitti’. lilt’ lepIll.lhltllIs (11 )111 Iliet .11 ( 2 ittii’. lllltielsttKlhi (StIll lll.tt IILt’th lit’ip silt Ii .us lIllIsluit’ tI)histlil•lhlts (It •IIltuthle’.sI Na uue . 1 1S t A cllllth)Ii.lllce Illiltel 4 Wi the .uiiti •iditpu .t Ll)IIII).IIl3 I S( A (iuuiit v 5 ‘sV 1 lie a t.tIllli lll.lllte iii.lihlIdI I Ii,tt Ill Utitles Ihie u liotetltlies 111 ,11 1 1(2 iiettssai ‘. flu keell I eh dill II)’. iii Ct liii pita i lid (1 RevIew (lie Lollipihallee prograni ‘.titli Chili isei or e h lhlsil Ita hits I ha I spec wI hid III 1 St A LI lhliu)ll.lilee 7 C ( Ih ltillet Ira uttlg for S ui llr ciltployees H ( ilil(ill(_l ZIhl lhltel 11 ,11 .ltudii ttf the i.tst ‘ 1St “¼ tI)llI( lilJlice 4) II 1)11 111)11 litill ellillihi I I 1 1cC 1 5 5 1 1C c, StOp ) dii ) uileg.uI . 1 11 u’.’itv I huthitedualely and contact St I hIr tu)lIItXilit’ ZItIt)iIle% ‘Vu lIlt LI 11111)118 iuce pni l I dill nitict have d c Illelils It) liahud lc I’M Ns Ii )OU company Ill,IIl Iii,lLIIliCs 1 1It1dttLlS 11181 thti 1)01 qualIFy huw t lie mutisinie exeniptioll I or exaiiipie. If 31111 111,1 I.e poiyniei s stiehu : 15 (XII ytIrel ha lies 1111 1 lustu III It I . Ii iti 1111’ uI I II ilu_’I t 11.11 i ’l L !’ 1L511l 5 ‘. 1111 luIuI:1I(lIl ilhIlsI ti iii’. stile v. Ii ‘I I II I. llitt sS.1I% Iuu l iii. .1 1 4 NIN. It ‘.‘.lii il’. . uitsi lul e’ttlI.llli Ii , ’’.’. it ’ 10111511’. Vt 1111 tI lt. hZ.¼ I i uiht_. IIltitItihIl tlte ilI)tlhlt.hIlIIll .111 11 htttllt Let_pill’! IttillIltilleilI S tlisLlls stti hhlO’.t ‘\li tiitt lu.e tllllfl)ii.llitt IlltlVl.111i ‘.tuII liuip St Ill lu I It ( ‘It I’,Iled 1111 tIle 11, 1’. tlc.u .11 1 II I ‘Pet Il l iltill ) I lie I IA t.iIhs (II I tutu 441111 11.1 11% ‘I 1 111 ‘. 5 ill lit’ lllehh.llttl I II lii . 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Find out who’s been promoted In American Point & Coatings Journal I I I ngl’rft ass I’sissss .V ( ulahsssgs Jcnsiiiiil ui /i I I t),55) ------- xYz ------- 0 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY In the Matter of ALCOLAC INCORPORATED ) Docket No. TSCA 89—H— 22 Respondent ) ___________________________________________________________________________________ ) Notice of Treatement of Confidential Business Information Portions of the attached Complaint require use of information which Respondent submitted to the United States Environmental Protection Agency (EPA) as Confidential Business Information (CBI). Information in the Complaint constituting or based on CBI has been deleted as indicated by the following: (CBI deleted). The original Complaint containing CBI is filed with the headquarters Hearing Clerk. It will itself be treated as confidential unless and until Respondent waives confidentiality thereto or EPA releases the information in accordance with 40 CFR Part 2. 000085 ------- UNITED STATES ENVIRONMENTA L 1 PROTECTION AGENCY _____________________________ Docket No. TSCA 89—H-22 COMPLAINT AND NOTICE OF In the Matter of ) OPPORTUNITY FOR HEARING ALCOLAC INCORPORATED ) UNDER SECTION 16(a) OF THE TOXIC SUBSTANCES Respondent ) CONTROL ACT This is a civil administrative action issued under the authority of Section 16(a) of the Toxic Substances Control Act, 15 U.S.C. 2601 et !. • (hereinafter “TSCA”). The Complainant is Michael F. Wood, Director, Compliance DivisioLl, Office of Compliance Monitoring, United States Environmental Protection Agency (EPA), who has been duly delegated the authority to institute this action. The Respondent is Alcolac Incorporated, Baltimore, Maryland. This Complaint serves as notice that Complainant has reason to believe that Respondent manufactured chemical substances in violation of Sections 5, 8 and 15 of TSCA, 15, U.S.C. Section 2614, as follows: ------- I —2— 1. On August 1, 1984, May 20—21, 1986, and June 12, 1987, inspections were conducted, by duly designated representatives of the EPA, at Respondent’s facilities located at 3440 Fairfield Road, Baltimore, Maryland and at Randall Road, Sedalia, Missouri, respectively. 2. These inspections were conducted to determine Respondent’s compliance with TSCA requirements. COUNT I 3. Paragraphs 1 — 2 are hereby incorporated and realleged as if fully set forth herein. 4. Respondent is a “person” as defined in 40 CFR Section 720.3(x) and as such is subject to TSCA and the regulations promulgated thereunder. S. Respondent’s records revealed that Respondent manufactured for commercial purposes the chemical substances as described in Counts I— tV, respectively. 6. On these occasions, the chemicals identified in Counts I—Ill of this Complaint, did not appear on the TSCA Inventory of Existing Chemical Substances (“TSCA Inventory”) maintained by the Administrator pursuant to 15 U.S.C. Section 2607. 000087 ------- —3— 7. Records revealed that Respondent manufactured a new chemical substance, (CBI deleted), chemical abstract number (CBI deleted), and iaentified by product code name (CBI deleted), hereinafter designated as Chemical A. 8. Section 5(a)(l) of TSCA, 15 U.S.C. 2604(a) (1), provides that no person may manufacture a chemical substance which does not appear on the TSCA chemical substance inventory without first submitting a Premanufacture Notification to the Administrator of EPA at least 90 days before manufacturing such substance. 9. Section 15(1) (B) of TSCA, 15 U.S.C. 2614(1) (B), provides that it is unlawful for any person to fail or refuse to comply with any requirement prescribed by Section 5. Section 15(3) (B) of TSCA, 15 U.S.C. 2614(3) (B) provides that it is unlawful for any person to fail or refuse to submit reports, notices, or other information as required by TSCA. 10. Respondent’s records revealed that between October 1979 and June 1986, Respondent manufactured (CBI deleted) pounds of Chemical A for TSCA conunercial purposes. During this time period, Respondent manufactured Chemical A on at least (CBI deleted) separate occasions. 11. Respondent failed to notify EPA of its intention to manufacture the new chemical substance, Chemical A, at least ninety (90) days before manufacturing Chemical A, thereby violating TSCA Sections 5(a) (1) (A), 15(1) (B), and 15(3) (B). ------- U —4— COUNT II 12. paragraphs 3 — 6 are hereby incorporated and realleged as if fully set forth herein. 13. Records revealed that Respondent manufactured a new chemical substance, (CBI deleted), CAS tt (CM deleted), and identified by product code name (CBI deleted), hereinafter designated as Chemical B. 14. Paragraphs 8 — 9 are hereby incorporated and realleged as if fully set forth herein. 15. Respondent’s records revealed that from March 1982 through December 1986, Respondent had manufactured (CBI deleted) pounds of Chemical B for TSCA commercial purposes. During this time period, Respondent manufactured Chemical B on at least (CBI deleted) separate occasions. 16. Respondent failed to notify EPA of its intention to manufacture the new chemical substance, Chemical B, at least ninety (90) days before manufacturing Chemical B, thereby violating TSCA Sections 5(a)(l)(A), 15(l)(B), and 15(3)(B). COUNT III 17. Paragraphs 3 — 6 are hereby incorporated and realleged as if fully set forth herein. 000089 ------- —5— 18. Records revealed that Respondent manufactured a new chemical substance, (CBI deleted), CAS * (CBI deleted) and identified by product code name (CBI deleted) , hereinafter designated as Chemical C. 19. Paragraphs 8 — 9 are hereby incorporated and realleged as if fully set forth herein. 20. Respondent’s records revealed that from October 1983 through December 1985 Respondent had manufactured (CBI deleted) pounds of Chemical C for TSCA commercial purposes. During this time period, Respondent had manufactured Chemical C on (CBI deleted) separate occasions. 21. Respondent failed to notify EPA of its intention to manufacture the new chemical substance, Chemical C, at least ninety (90) days before manufacturing Chemical C, thereby violating TSCA Sections 5(a) (1) (A), 15(1) (B), and 15(3) (B). COUNT IV 22. Paragraphs 1 — 2 are hereby incorporated and realleged as if fully set forth herein. 23. Information collected during the inspections and subsequent information submitted by the Respondent revealed that Respondent manufactured for TSCA commercial purposes, as defined at 40 CFR Part 712.3, the following chemical substances listed as chemical abstract service registry numbers, (CAS *3) from January 1981 through December 1981: ------- —6— CAS $ Chemical Production Amt (CBI deleted) Chemical D (CBI deleted) (CBI deleted) Chemical E (CBI deleted) 24. According to 40 CFR Section 712.20(a), a person who manufacture in bulk form one or more of the chemical substances listed in 40 CFR Section 712.30 for commercial purposes must submit a Preliminary Assessment Information Report, (hereinafter referred to as a PAIR), to the Administrator of EPA, as required under Section 8(a) of TSCA. 25. Respondent is a “person” as defined in 40 CFR Section 712.3 (6). 26. Section 8(a)(l) of TSCA authorized the Administrator of EPA to issue rules that requires reporting by manufacturers, importers and processors of chemical substances. The PAIR rules were promulgated on June 2, 1982 under 40 CFR Part 712, Subpart B entitled, Manufacturers Reporting—— Preliminary Assessment Information. Section 15(3) (B) of TSCA, 15 U.S.C. 2614(3) (3) provides that it is unlawful for any person to fail or refuse to submit reports as required under TSCA. 27. According to 40 CFR Section 712.30(a), Respondent was required to submit a PAIR for Chemicals D and E covering their 1981 calendar year production on or before November 19, 1982. 000091 ------- —7— 28. As of the date of EPA’s August 1, 1984 inspection, Respondent had not submitted a PAIR for Chemicals D and E on or before the November 19, 1982 reporting date as required. 29. On or about August 1, 1984, Respondent submitted PAIRs for Chemicals D and E to the Agency pursuant to 40 CFR Section 712.30(a). 30. On or about November 7, 1986, two years after the August 1984 submissions, Respondent supplied the Agency with a revised PAIR for Chemical D. 31. As described in Paragraphs 28 and 30 above, Respondent violated Section 8(a) and 15(3)(B) of TSCA in that Respondent failed to submit a PAIR for Chemicals D and E to the Administrator of EPA for the reporting date as required. COUNT V 32. Paragraphs 1 — 2 are hereby incorporated and realleged as if fully set forth herein. 33. On or about June 18, 1978, the Respondent reported to EPA that the Respondent had manufactured chemical substances listed as CAS #s (CBI deleted and CBI deleted), hereinafter designated as Chemicals F and C, substances for TSCA commercial purposes since January 1, 1975. 34. On or about May 29, 1979, the Respondent reported to EPA that the Respondent had manufactured the chemical substance listed as CAS $ (CBI deleted) , hereinafter designated as Chemical H, a substance for TSCA commercial purposes since January 1, 1975. ------- —8— 35. Pursuant to Section 8(a) of the Act, 15 U.S.C. Section 2607(a), EPA promulgated the “Inventory Reporting Regulations”, codified at 40 CFR Part 710. 40 CFR Part 710 establishes regulations governing reporting certain sub- stances for commercial purposes under Section 8(a) of the Act. 36. Pursuant to 40 CFR Sections 710.3 and 710.4, all persons wno manufactured and/or imported a chemical substance for a commercial purpose during 1977 were required to submit specific information to EPA concerning that chemical substance for inclusion in EPA’S initial TSCA inventory of chemical substances manufactured for commercial purposes under the Act, and only persons who manufactured or imported a chemical subtance for commercial purposes from January 1, 1975 to July 1, 1979 were permitted to report to EPA concerning that chemical substance for EPA’S TSCA Inventory of Chemical Substances. 37. Supplemental information submitted by the Respondent subsequent to the inspections, revealed that chemical substances F, C, and H cited in paragraphs 33 and 34 of this Complaint had not been manufactured by Respondent for commercial purposes at any time since January 1, 1975. Respondent therefore was not permitted to report these chemical substances for EPA’S TSCA Inventory of Chemical Substances. 000093 ------- —9— 38. Respondent was the sole submitter of each of the chemical substances E’, G, and H cited in paragraph 33 and 34 of this Complaint for EPA ’s TSCA Inventory of Chemical Substances. 39. Pursuant to Section 15(3) of the Act, 15 U.S.C. Section 2614(3), it is lawful for any person to fail or refuse to establish and maintain records or to submit the reports, notices or other information as required by the Act or a rule thereunder. 40. As described in Paragraphs 33, 34, and 37 above, Respondent violated Sections 8(a) and l5(3)(B) of the Act, 15 U.S.C. Sections 2607(a) and 2614(3) (B) by reporting chemical substances F, G, and H as chemicals manufactured by Respondent for commercial purposes. PROPOSED civir PENALITY Section 16 of TSCA, 15 U.S.C. Section 2615, authorizes the assessment of a civil penalty of up to $25,000 per day for each violation of TSCA. Based upon the facts alleged in this Complaint, and upon the nature, circumstances, extent and gravity of the violations alleged, as well as Respondent’s history of prior violations of TSCA, the degree of culpability and such other matters as justice may require, the Complainant proposes that Respondent be assessed the following civil penalty for the violations alleged in this Complaint: ------- COUNTS I - III Failure to notify of intention to manufacture a new chemical substance: 15 U.S.C. 2604 (a)(1) 15 U.s.c. 2614 (1) (B) 15 u.s.c. 2614 (3)(B) .... $ 273.000 ...... $ 16,500 . $ 145.000 COUNT ..... $ 434,500 COUNT IV Failure to submit PAIR reports as required: 15 U.S.C. 2607 (a)(] ,) 15 U.S.C. 2614 (3) (B) COUNT ................. .. $ 68,378 COUNT V False reporting of chemical substances as manufactured for commercial purposes. Respondent is sole submitter of each cnemical to EPA TSCA Inventory: 15 U.S.C. 2607 (a)(1) 15 U.S.C. 2614 (3)(B) COUNT . . . . . . . . . . $ 51, 000 TOTAL PROPOSED CIVIL PENALTY ......... $ 553878 000095 ------- —11— NOTICE OF OPPORTUNITY TO REQUEST A HEARING As provided in Section 16(a) (2) (A) of TSCA, you have the right to request a formal hearing to contest any material fact set forth in this Complaint or to contest the appropriateness of the proposed penalty. Any hearing requested will be conducted in accordance with the Administrative Procedures Act, 5 U.s.c. Section 551 et seq. , and the Consolidated Rules of Practice Governing the Administrative Assessment of Civil Penalties , 40 CFR Part 22 ( “Consolidated Rules of Practice”) . A copy of the Consolidated Rules of Practice accompanies this Complaint. To avoid being found in default, which constitutes an admission of all facts alleged in the Co nplaint and a waiver of the right to a hearing, and having the above penalty assessed without further proceedings, you must file a written Answer within twenty (20) days of receiving this Complaint . Pursuant to the Consolidated Rules of Practice, your Answer must clearly and directly admit, deny, and/or explain each of. the factual allegations contained in this Complaint with regard to which you have any knowledge. If you have no knowledge of a particular fact and so state, the allegation is considered denied. Failure to. deny any of the allegations in this Complaint will constitute an admission of the undenied allegation. ------- —12— The Answer shall also state the circumstances and arguments, if any, which are alleged to constitute the grounds of defense, and shall specifically request an administrative hearing, if desired. If you deny any material fact or raise any affirmative defense, you will be considered to have requested a hearing. The Answer must be filed with: Headquarters Hearing Clerk (A—].l0) United States Environmental Protection Agency 401 M Street, S.W., Room M3706 Washington, DC 20460 Please send a copy of the Answer an all other documents which you file in this action to Vincent Giordano, the attorney assigned to represent EPA in this matter, at: Toxics Litigation Division (LE—134P) Office of Enforcement and Compliance Monitoring U.S. Environmental Protection Agency 401. H Street, S.W., Rm. NE 113A Icasnington, D.C. 20460 INFORMAL. SETTLIEMENT CONFERENCE Whether or not you request a hearing, you may confer informally with EPA through Mr. Giordano regarding the facts of this case, or amount of the proposed penalty, and the possibil. ty of settlement. An informal settlement conference does not, however, affect your obligation to file a written Answer to the Complaint. 000097 ------- —13— EPA has the authority, where appropriate, to modify the amount of the proposed penalty to reflect any settlement reached with you in an informal conference. The terms of such an agreement would be embodied in a Consent Agreement and Final Order (“CAFO”). A CAFO signed by EPA and you would be binding as to all terms and conditions specified therein upon signature by the EPA Chief Judicial Officer. Please be advised that the Consolidated Rules of Practice prohibit any ex parte (unilateral) discussion of the merits of any action with the Administrator, Cnief Judicial Officer, Administrative Law Judge, or any person likely to advise these officials in the decision of the case, after the Compliant is issued. PAYMENT OF PENALTY Instead of filing an Answer requesting a hearing or requesting an informal settlement conference, you may choose to pay the proposed penalty. Such payment should be made by sending a cashier’s or certified check payable to the United States of America in the amount of the penalty assessed in this Complaint. The check should be mailed to: EPA-Washington (Hearing Clerk) P.O. Box 360277M Pittsburgh, PA 15251 ------- |