Document 91oo5034JdJRqrxQ2oY65MpJD

TO: Distribution FROM: DATE: Interoffice SUBJ: Communication T. G. Grumbles July 16, 1987 TSCA 8(D): LONZA CASE VISTA Regarding the proposed penalty against Lonza for not submitting an EO area monitoring report under Section 8(d), the agency has decided ... "never mind". The agency is dropping the complaint. This decision (attached) is based on the agency receiving agency interpretation information ffom early in the 8(d) program, during the pre-trial hearing. The agency states they are investigating why they didn't find their own interpretations in the files, but feels this resulted from transfer of personnel. EPA plans to publish further clarification and a proposed rulemaking regarding the status of monitoring studies under the 8(d) rule. ' CT1'---------- T. G. Grumbles aj o .202 Attachment cc WLM Dist: Safety Directors Environmental Coordinators VVV 000015203 . .j__ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY /. In the Matter of LONZA INCORPORATED Respondent ) ) ) ) ) ) Docket No, TSCA-87-H-03 MOTION TO WITHDRAW COMPLAINT Complainant U.S, Environmental Protection Agency (EPA) respectfully moves to withdraw the Complaint in the above-captioned matter, pursuant to 40 C.F.R. 522.14(e) of the Consolidated Rules of Practice, In support of this Motion, Complainant files the attached Memorandum In Support of Motion To Withdraw Complaint, and proposed Order, incorporated herein by reference. Complainant is authorized to state that Respondent consents to the Motion to Withdraw Com plaint, but has not reviewed and does not necessarily endorse the arguments in the Memorandum In Support of Motion to Withdraw Com plaint . Respectfully submitted. Date Office of Enforcement and Compliance Monitoring vvv 00001520* UNITED STATES ENVIRONMENTAL PROTECTION AGENCY c/> * -------------------------------------------------------------- > /^ In the Matter ofs LONZA INCORPORATED Respondent, ) ) ) ) ) ) Docket No, TSCA-87-H-03 MEMORANDUM IN SUPPORT OF MOTION TO WITHDRAW COMPLAINT I, INTRODUCTION Complainant U.S. Environmental Protection Agency ("EPA or the Agency") respectfully moves to withdraw the Complaint in the abovecaptioned action, pursuant to 40 CFR 22.14(e) of the Consolidated Rules of Practice. It is appropriate to withdraw the Complaint in light of newly available information regarding the TSCA 1/ Section 8(d) rule 2/ at issue in this action. This information documents a pattern of interpretation of the rule by the original Agency staff responsible for developing and implementing the program supporting the conclusion that the rule does not require studies such as Respondent Lonza Incorporated*1s ethylene oxide monitoring study to be submitted to EPA. Complainant is moving to withdraw the Complaint at this point in the proceedings because it now concludes, upon reviewing cumula tively all of the evidence before this Court, including previously unavailable evidence in Respondent's June 16, 1987 Prehearing State ment, that the intent of the rule was to exclude Respondent's study. ----------------------------------------------------------------------------------------------------- VVV OOI5205 1/ Toxic Substances Control Act, 15 U.S.C. 552601 et seq. 7/ 40 CFR 716.3(c), (e), and (j), 716.6, and 716.17"(ITU). 2- - As discussed below, this conclusion should not be interpreted as supporting the withdrawal of a Complaint in a case where EPA staff may have given informal guidance inconsistent with the official Agency interpretation of the rule. Complainant regrets the necessity to have to terminate this action at this stage of the proceedings. However, as the duly authorized representative of the people of the United States, Complainant acknowledges its duty to review diligently, in good faith, and at any point in time, all information provided to it in an enforcement proceeding. Where the appropriate conclusion is that further action is not warranted. Complainant will act according ly, even if this should necessitate withdrawing a filed Complaint. II. HISTORY This action is a civil administrative enforcement action, filed pursuant to TSCA section 16, naming Lonza Incorporated as the respondent. The Complaint sought civil penalties from the Respondent for violating TSCA section 8(d) and regulations thereunder. The violation arose from the Respondent's failure to submit to Complain ant a copy of a specific monitoring study on a TSCA section 8(d)listed chemical. On September 26, 1985, an authorized EPA employee lawfully inspected Respondent's facility pursuant to TSCA Section 11. During this inspection. Respondent provided to EPA a copy of a study conducted for Respondent by John Kelse, Industrial Hygienist, The Hartford Insurance Group, entitled, "A Workplace Environmental VVV 000015206 -3- Study for Air Contaminants (Process Exposures and Fugitive Emissions)", on the chemical substance ethylene oxide (the "EtO study")* The study was completed on April 9, 1981, and provided to Respondent on June 24, 1981. Pursuant to TSCA 58(d), and 40 CFR 716.3(c), (e), and (j), 716.6, and 716.17(a)(1), Respondent was required to submit to EPA a copy of any "health and safety study", in its possession, on ethylene oxide between October 4, 1982 and December 3, 1982. Respondent did not provide a copy of the EtO study to EPA within this time period. EPA filed a civil administrative Complaint against Respondent on October 23, 1986 seeking penalties for failing to submit the study. The factual and legal bases for the Complaint are described fully in the Complaint, incorporated herein by reference. Respondent filed an Answer and Request for Hearing on April 6, 1987 (incorporated herein by reference). In Part II of the Answer, Respondent sets forth a number of "Affirmative Defenses". In Part II 1., Respondent argues that, for several reasons, the study does not constitute a "health and safety study" as per the section 8(d) rules. In Part II 2.(v), Respondent argues that "EPA never gave notice to Lonza or the chemical industry generally of the interpreta tion of Section 8(d) on which it relies this case, and that inter pretation is not set forth in the text or preambles of EPA's proposed and final Section 8(d) regulations." Answer at 5. Between April 6 and June 16, 1987, sundry motions and responses were filed by both parties to this action. On June 16, 1987, the Prehearing Exchange took place as directed by this Court. Respond ent's Prehearing Statement includes, inter alia, 11 exhibits (num- VVV 000015207 -4- bered "2" through "12") documenting industry contacts with EPA staff regarding the interpretation and implementation of the section 8(d) rule- The exhibits include a letter on EPA stationary inter preting the rule as excluding 2 studies very similar in content to the Respondent's study* Respondent's Prehearing Statement, Exhibits 10 and 11* EPA had not located any records of these contacts prior to receiving Respondent's documentation. III. ARGUMENT Upon reviewing all available information, including the docu mentation appended to Respondent's Prehearing Statement, and analyz ing further the utility of data in studies such as the Lonza study to EPA regulatory programs, the Agency has concluded that no penalty is warranted and accordingly moves to withdraw the Complaint in this action. The most important factor justifying the withdrawal is the conclusion that the rule was intended to exclude the EtO study. 3/ This information, consisting of documentation of a pattern of interpretation of the section 8(d) rule by EPA staff early in the history of the program, was not available to EPA until supplied by Respondent in the June 16p 1987 Prehearing Exchange, and thus was not considered in the decisionmaking process culminating in the 3/ The EtO study consists of one-time area sampling to determine compliance with an OSHA or industry workplace standard on a given day. It states that contaminant levels are below the standard and that no specific recommendations appear waranted. 00Q015Z08 VVV -5- filing of the Complaint in this action. 4/ In moving to withdraw the Complaint, Complainant stresses the narrow ground upon which the withdrawal is predicated, viz, the the fact that a review of the available evidence demonstrates that the proper interpretation of the section 8(d) rule is that Respond ent's study is not reportable. Complainant notes that Respondent has not, at any point in this proceeding, claimed by way of defense to have relied detrimentally on any of the staff interpretations of the section 8(d) rule which it has documented. Indeed, even such persons would not be entitled to judgement against the United States where the unofficial advice was inconsistent with the regula tions as interpreted officially by the Agency entrusted with their administration. E.q., Schweiker v. Hanson, 450 U.S. 785 (1981). Thus, the significance of the documentation of the Agency's original interpretation of the section 8(d) rule is to indicate the correct scope of that rule, and not to imply any right of estoppel against the United States as a result of inconsistent or erroneous staff 4/ EPA is presently investigating why this occured. At present, the problem appears to have had its genesis in the Office of Toxic Substances' October 30, 1983 reorganization. One result of the reorganization, and certain contemporaneous reassignment of staff, was a transfer of section 8(d) responsibility from the staff origi nally responsible for its interpretation and implementation to new staff. While such reorganizations and reassignments are not uncommon and typically cause no significant regulatory problems, it appears that in this case certain section 8(d) records were not transferred to the new staff, and the new staff were not made aware of the prior pattern of interpretation of the rule by the original staff. As discussed above, EPA is taking immediate action to determine how and why this occured and correct any problems uncovered. VVV 000015209 guidance. 5/ In revisiting the interpretation of the section 8(d) rule with the original staff responsible for drafting and interpreting the language and implementing the program. Complainant also reviewed the utility of data such as those contained in the EtO study to EPA's regulatory programs and the burdens which the broad interpre tation of the section 8(d) rule set forth in the Complaint would place on industry. These factors were considered by the original staff in developing the section 8(d) rule and program. Complainant has confirmed that the data contained in studies such as the EtO study would, in most cases, be of little value to EPA in its sections 4 ("Testing of chemical substances and mixtures"), 5 ("Manufacturing and processing notices"), and 6 ("Regulation of hazardous chemical substances and mixtures") programs. Though the data would be of value to the Agency in certain circumstances such as, for example, when investigating chemicals for which little or no monitoring data are available or for which the primary regulatory issue is whether systems claimed to be "closed" are functioning as described, such unusual cases do not appear to justify the burdens attendant with routinely submitting such information to EPA despite the grant of statutory authority to require such information to be submitted. 5/ It is common knowledge that employees of most, if not every government agency may occasionally provide informal guidance to regulated entities upon request. The United States, however, is a nation of law, and binding legal obligations are created solely by statute and regulation, not by informal staff opinions. For this reason, the law has always been clear that persons receiving such opinions rely on them at their own initiative and peril. See Schweiker, 450 U.S. 785. 000015210 VW -7- Complainant recognizes the need to further clarify the scope of the section 8(d) rule. The Office of Toxic Substances (OTS) will therefore issue additional guidance in the near future discuss ing the status of monitoring studies under the section 8(d) rule. In additionr OTS is planning to initiate a rulemaking action to amend the section 8(d) rule to reflect these matters. EPA will provide public notice of any such rulemaking# and interested persons will be provided with an opportunity to participate. III. CONCLUSION The proposed withdrawal of the Complaint is justified under the circumstances and will not prejudice Respondent in any way. Accord ingly# the Motion to Withdraw Complaint should be granted. Respectfully submitted# Date Office of Enforcement and Compliance Monitoring UNITED STATES ENVIRONMENTAL PROTECTION AGENCY In the Matter of: LONZA INCORPORATED Respondent. ) ) ) ) ) ) ) Docket No.TSCA-87-H-03 ORDER By Motion dated July 10, 1987, Complainant U.S. Environmental Protection Agency (EPA) moves to withdraw the Complaint in the above-captioned action. I have carefully reviewed the filings in this matter and find that it is appropriate under the circumstances for the Complaint to be withdrawn. Therefore, it is hereby ORDERED that, for cause shown, the Complaint is withdrawn per Complainant's Motion. Date Gerald Harwood Chief Administrative Law Judge 0O0O152*2 vvv CERTIFICATION I hereby certify that the original of the foregoing Motion to Withdraw Complaint, Memorandum in Support of Motion to withdraw Complaint, and Order, Docket No. TSCA-87-H-03, have been filed with the Headquarters Hearing Clerk, and that copies were sent, registered or certified mail, return receipt requested, first class mail, or hand-delivered to: Hon. Gerald Harwood Chief Administrative Law Judge Office of the Administrative Law Judges U.S. Environmental Protection Agency 401 M Street, S.W. Washington, D.C. 20460 (A-110) Robert M. Sussman, Esq. Covington & Burling 1201 Pennsylvania Ave., P.0. Box 7566 Washington, D.C. 20044 N.W. David F. Zoll, Esq. Gabrielle H. Williams, Esq. Chemical Manufacturers Association 2501 M Street, N.W. Washington, D.C. 20037 Date 'Toxics Litigation Division (LE-134P) U.S. Environmental Protection Agency 401 M Street, S.W. Washington, D.C. 20460 TO: Environmental Standards Team Meeting FR.OM: Interoffice DATE: Communication SUBJ: T. G. Grumbles July 14, 1987 JULY 23 MEETING VISTA The July 23 meeting will be held in Timberway I, Conference room 2A. At the last meeting we developed a goals statement, discussed goals and focus of our initial effort, how the guidelines would be used and interact with standards, and the benefits of the effort or "end product". At this meeting, I would like to focus on the point in a project or the budget process the guidelines would be used and what is needed at those points. For instance, is a specific direction regarding a specification reference best or a general guideline regarding degree of environmental protection useful, when when no regulation is applicable. This will be done by reviewing the process used in two past projects. Hopefully this exercise will lead us to a clear idea of what the form of our "end-product" should be, and allow us to proceed with drafting the format and substance. A draft agenda is attached. Please call if you have additions or other thoughts prior to the 23rd. T. G. Grumbles aj o Attachment Distribution: T. W. Heller / C. R. Dutra / J. 0. Gibson M. G. Hayes / J. D. Stone / R. T. Ferrell ooooV^ AGENDA JULY 23. 1987 I. Review of Last Meeting Notes and Conclusions II. Revisit/Reconfirm Goals Statement III. Review of Past Project Processes A. Baltimore Acid Sewer B. VCM Acid Pits IV. Review Above to Determine What Type of and Where Guidelines Would Have Been Helpful V. Discuss and Formulate Guideline Format VI. Schedule and Process for Completion TGG Group JOG TWH Group Group o0001.`i2'L5