Document g2VyEeVzZBeBKQgY4E33jV48Q

a DA id Ith. to i 10 for j* ni. | K ! i r I Y * {> if t V Tuesday June 8, 1982 Part VII Environmental Protection Agency Polychlorinated Biphenyls {PCBs); Manufacture, Processing, Distribution, and Use in Closed and Controlled Waste Manufacturing Processes; Proposed Rule 0756051 TOWOLDMON0060204 24978 Federal Register / Vol 47, No. 110 / Tuesday, June 8,1982 f Proposed Rule* ENVIRONMENTAL PROTECTION AGENCY [40 CFR Part 761] [OPTS U017A; TSH FRL 2103-7) Polychlorinated Blphenyfe (PCBs); Manufacture, Processing, Distribution, and Use In Closed and Controlled Waste Manufacturing Processes agency: Environmental Protection Agency (EPA). action: Proposed rule. . Summary: On April 13,1881. the U.S. Court of Appeals for the District of Columbia Circuit issued an order requiring the Environmental Protection Agency (EPA) to undertake a rulemaking for certain chemical manufacturing processes that generate PCBs in low concentrations. In response to the court's order, EPA is proposing to exclude the production of PCBs in closed and controlled waste manufacturing processes from the provisions of section 6(e) of the Toxic Substances Control Act fTSCA), 18 U.S.C. 2805(e). Section 6(e) prohibits the manufacture, processing, distribution in commerce, and use of polychlorinated biphenyls (PCBs). . dates: An informal hearing. If requested, will be held on August 6, 1882, in Washington. L).U lhe exact time and location of the hearing will be available through the industry . Assistance Office; which can be* reached by railing toll free 800-124-9065 or, in Washington, D.C, by calling 554-1404. Comments on this proposed rule and requests to participate in the informal hearing must be submitted by July 23. t9a__HI : adoresses Comments should be submitted to: Document Control Officer (TS-793), Office of Pesticide* and Tcodc Substances. Environmental Protection Agency. Rm. E-409,401M SL, SW, Washington, D.C 20400. j pom further information contact: Douglas G. Bannerman, Acting Director. Industry Assistance Office (TS-799), Office of Toxic Substances. Environmental Protection Agency, Rm . E-509,401M St, SW,, Washington. D.C 2046a Toll Free: (800-424-8056); In Washington. D.C: (554-1401); Outside the USA: (Operator 202-554-1104). SUmCMENTAJIY INFORMATION ' L Reaxfificatioo of 40 CFR Part 7U Notice of the recodification of 40 CFR Part 761 appears in the Federal Ragjsts* of May 6.1882 (47 PR 18627). Thia proposed rule contains the new designations - 1 1 fornwr dmqpmicm the likelihood of exposure is so low. Therefore, the Joint motion proposed r. -- mi im a that EPA would publish an Advance Notice of Proposed Rulemaking (ANPR) r.NNRR mi m Ml TO requesting comments on the possible exclusion of the production of PCBs in SmcNob 791.41. these processes from the provisions of section 6(e). ' D. Background . EPA attempted to identify and define specifically these processes where there Section 6(e) of the Toxic Substancee are negligible public health and Control Act (TSCA) prohibits the environmental benefits to be derived manufacture, processing, distribution In from regulation because the processes commerce, and use of polychlorinated present such low risks. Two process biphenyls (PCBs). However, the statnte enables EPA to promulgate regulations categories were identified. These are -closed manufacturing nrocee" and to reduce the Impact of the ban. EPA promulgated regulations, published in ''controlled waste manufacturing processes." ' ~ the Federal Register of May 31.1979 (44 "Closed manufacturing processes" FR 31514), to implement section 6(e) of were defined as those in which PCBs are TSCA. The regulations, among other generated but from which no PCBs are things, generally excluded from the ben * released. These processes generate materials containing PCBs in PCBs within closed reaction equipment concentrations less than 50 parts per and the chemical reactions within the million. " processes continuously destroy the The Environmental Defense Fund PCBa as they are produced. (EDP) obtained judidal review of the - "Controlled waste manufacturing regulations in the U.S. Court of Appeals processes'* were deflned~as processes in for the District of Columbia Circuit EDP which PCBs are generated but from challenged the provisions described whidTPCBs are released only as above; among others. On October 30, constituents of wastes that are either 1980, the court invalidated the regulatory exclusion for concentatians below 50 ppm Environmental Defense * incuentea disposed of in EPA* approved landfills, or stored ior later tndaerationor landfilling. Fund v. EPA. 636 F. 2d 1287. The court remanded the rule to EPA for further actioo consistent with the opinion. The court's decision placed industries that had relied upon the PCB Ban Regulations in a difficult position. Issuance of the court's mandate would have activated section 6(e)'s brand prohibitions on the manufacture, processing, distribution in commerce, end use of PCBs. The result would be that many activities in industries throughout the United States would be banned.' . Accordingly, the parties to the lawsidt In addition to dealing with closed and controlled waste processes, the February 20 Joint motion also proposed to publish an ANPR requesting information on all other manufacture, processing, distribution in commerce, and nee of PCBs in low concentrations. PCBs generated in and released from ' other than doted or controlled waste processes are referred to as "uncontrolled PCBs." On April 13,1981, the court entered an order in EDP r EPA. in response to the February 28 Joint motion. The text of the filed a Joint motion (on February 20, court's order is set forth in the Federal 1961) to seek a stay of the court's . mandate. The Joint motion proposed that during the period encompassed by the - Register of May 2a 1981 (46 FR 27615). The April 13 order stayed issuance of the court's mandate with respect to stay: (1) EPA would conduct new activities relating to PCBa in rulemaking with respect to PCB*: and (2) concentrations below 50 ppm. Thus, the industry groups would initiate studies to 50 ppm regulatory cutoff remains in provide information foT the new effect fin the duration of the stay, and rulemaking. - persons who manufactnra, process, During discussions which led up to this )oint motion, representatives at distribute in commerce, and use PCBs in concentrations less than 50 ppm may some affected Industries stated that * continue these activities during the stay. some of the processes which prodocs The order also adopted a plan for PCBs are designed and operated so that' farther actions by EPA and Industry no releases of PCBs oocur or that the poops leading toward new EPA PCBs formed in the processes are rulemaking cm the regulation of PCBa in disposed of appropriately. - concentrations below 50 ppm. The April Consequently, virtually no risk to* 19 order required EPA: (1) To publish ' tinmans or the environment is two ANTE* on developing rules to cover ...nriiwl with such processes became PCBs in concentrations below 60 ppm: 0756052 TOWOLDMON0060205 Federal Eagbter / VoL 47, No. MO / Tuesday, lone & 1982 f Promoted Rales 24977 (2) to promulgate a final rale, within eighteen montha from the date of the order (Le., October 13,1982). with reaped to exduaion of the generation of PCB* in dosed and controlled waste manufacturing processes from the prohibitions of section 6(e)(3). or to - explain the reasons for not proceeding with such a rule; and (3) to advise the court, within eleven months after the date of the order (Le,, March 13,1982), of EPA'* plans and schedule for further action on PCBi in concentrations below SO ppm generated as uncontrolled PCBs. On May 20.1981, EPA published two ANPRs on the 50 ppm regulatory cutoff (46 FR 27617 and 46 FR 27619). The ANPRs established bifurcated rulemaking proceedings with rasped to PCBs in concentrations below 50 ppm. The first ANPR announced activities that EPA.believed may lead to rulemaking on PCBs generated in dosed and controlled waste manufacturing processes. The second ANPR announced the framework for the Agency's exploration of the scope of the emblem presented by PCBs in concentrations below 50 ppm in other than dosed or controlled waste processes. In the . ANPRs, EPA stated that.it needed to develop a substantia] factual basis to support rulemaking on these PCBs. The comment period for both ANPRs expired on November 181961. . Approximately SO public comments ^*Were submitted. The most significant submission was filed by the Chemical Manufacturers Assoaation ("CMA"), a trade assoaation whose membership indudes many of the nation's prindpal manufacturers of primary chemicals. As explained further below, EPA has relied on CMA's submission to a significant extent because CMA has collected the . most comprehensive set of data on the generation of PCBs in concentrations below 50 ppm. * On March 11,1982, EPA submitted, in accordance with the April 13,1981 coart order, a report to the court that . contained its plans for further regulatory action on uncontrolled PCBs. In its report to the court. EPA stated that it . could not adequately define its plans for regulatory action for uncontrolled PCBe until it had a reasonable estimate of the number of processes that would be subject to the rulemaking. That number cannot be determined until EPA has defined doaed end controlled waste processes and determined the number of processes excluded from the provisions of section 6(e) by the doted and controlled waste process rulemaking. Therefore, EPA requested that the court allow EPA to report on its further plans for regulatory action on uncontrolled PCBs following the completion of the rulemaking an dosed and controlled waste processes EPA also requested that the court extend Ha stay of mandats until December 2.1962, to allow EPA time to develop suffidently detailed plans for regulatory action on uncontrolled PCBs after issues hi this rulemaking on doted systems and controlled waste processes are resolved. On April 9,1982, the court granted EPA's request IIL Summery of die Available Date on Manufacture at PCBs in Low A. Information Provided by CMA EPA received about 50 submissions and comments in response to the ANPR. The Chemical Manufacturers Association (CMA) submitted the most comprehensive information to ETA regarding dosed and controlled waste manufacturing processes. CMA is a trade association whose membership consists of nearly 200 companies, induding some of the nation's largest chemical manufacturers. CMA distributed detailed questionnaires to its membership which were designed to elidt information on the nature and extent of PCBs produced in ehntrjt . . manufacturing processes in concentrations under 60 ppm. After analyzing the data supplied by its members, CMA submitted its final report. "A Report of a Survey on the Inddental Manufacturing. Processing, Distribution, and Use of Polychlorinated Biphenyls at Concentrations Below 50 PPM" to EPA. This survey represents a major portion of the data base for this rulemaking; therefore, EPA requests comments concerning thn dntn contained in the survey. ' Copies of the CMA survey are . available far review in the public rulemaking record from 8c00 us. to 440 Km, Monday through Friday, eduding lidays, in Room B-10SL ETA. 401M SL 8.W. Washington. D.C. Copies of the CMA survey, are also available for a fee, by contacting the Industry Assistance Office at (600-424-0065), in Washington. D.C (544-1404). CMA found that PCBs are formed hi a wide variety of industrial chemical processes. The CMA survey suggests that PCBs can be generated from virtually any starting hydrocarbon structure. Indeed. PCB formation appears to be possible whenever chlorine end carbon are present in a reaction vessel at elevated - temperatures. These PCBs are formed as Impurities and byproducts far manufacturing processes and constitute only a very small percentage of process Of 85 respondents to the CMA survey. 28 chemical firms believe that they produce 13.766 pounds of.PCBs per year. These PCBs appear as impurities or byproducts in 135 chemical manufacturing processes at concentrations under 50 ppm. The respondents to the CMA survey reported that 9486 pounds of these PCBs are incinerated. 1,789 pounds are disposed of hr surface waters, 1,376 pounds are disposed of in landfills, 550 pounds are disposed of by ground injection and 275 pounds are disposed of in EPA-approved landfills. The respondents alto reported that approximately 700 pounds of PCBs are contained in the products of the manufacturing processes. . CMA believes that in this country a large number of processes, perhaps aa many aa several thousand, may generate PCBs in concentrations under 50 ppm as impurities and byproducts in industrial chemical manufacturing processMf However, they believe that most of the pounds of PCBs produced in these low concentrations in all chemical manufacturing processes throughout the United States have been accounted for by respondents to the CMA survey. This Is because CMA believes that respondents to the survey represents a very high percentage of principle chemical producers. The respondents Identified four processes in which they believe PCBs are generated and continuously destroyed in dosed reaction equipment They Indicated that about 0.7 pound of PCBs are found at any one time in these four processes. The respondents also identified forty processes in which PCBs are produced and are released only as constituents of wastes which are incinerated or disposed of in an EPAapproved landfill Approximately 6,900 pounds of FBCs are reportedly generated In these forty processes. Incineration was defined in the survey questionnaires as Incineration in compliance with "applicable" . regulations. This definition indudes municipal incineration in compliance with local and regional regulations but not necessarily incineration in accordance with EPA's rules for___ disposal of materials containing PCBs at concentrations greater than 50 ppm (43 FR 7150). B. EPA Estimates ofPCB Generation in Low Concentrations Since the 85 chemical firms who responded to the survey represents 374 percent of industrial chemical sales, EPA has multiplied the amount of PCBe 0756053 \ T OWOLDMON0060206 24978 Federal Register / VoL 47, No. 110 / Tuesday, June 8, 1982 / Propoeed Rules reported In the CMA survey (13,788 pounds) by 2.8 to obtain an estimate of the total amount of PCBs produced In concentrations under 50 ppm in all processes in the United States (i.e, 35,800 pounds). This figure is considered an upper limit because, as CMA commented, not all chemical firms manufacture chemicals from reactions; many firms conduct formulation only. Assuming the CMA data are accurate and. as reported by CMA. 50 percent of PCBs produced in concentrations under 50 ppm are produced in processes which meet EPA's initial definitions of closed and controlled waste processes (as they appeared in the May 20,1061ANPR), then up to 18,000 pounds of PCBs per year could be produced in the United States in these processes. . C Additional Data While section 8(e) of TSCA generally bans the manufacture of PCBs, it also establishes a mechanism for permitting continued manufacture of PCBs in certain situations. This mechanism is the exemption process, whereby persons may petition the Agency for relief from the PCB ban. Approximately forty petitions for exemption from the section 0(e) ban on the manufacture of PCBs were received by EPA following the publication of the May 31,1878 rule. Data provided in these petitions indicate that about 75,000 pounds of PCBs per year currently are generated in processes in which PCB concentrations at the point of manufacture exceed 50 ppm. In the same way that CMA classified the processes from , respondents to its survey, some of these processes can be classified as processes which do not release PCBs or as processes which release PCBs only as constituents of wastes which are either incinerated or disposed of in EPAapproved landfills. By extrapolating from the CMA data covering processes with PCBs below 50 ppm to these cases (i.e. above 50 ppm), EPA estimates that as much as an additional 38,000 pounds of PCBs per year could be generated in processes where the process in considered a closed process.or a . controlled waste process. H*A does not believe that the percentage of closed and controlled waste processes producing over 50 ppm PCBs will be significantly different from the percentage producing below 50 ppm. IV. Discussion of the Proposed Rule ' A. Overview of the Rule Federal courts have recognized the Mde minimis" exception to legislative mandates. Although the court in EDPr EPA overturned portions of the Agency's PCB regulations, it nevertheless noted that administrative agencies have the power "inherent in most statutory schemes, to overlook that In .y fairly be considered de minimis." 838 F-2d - 1283. Courts and agencies should be reluctant to apply a statute literally in pointless expenditure of effort where regulation would yield a gain of trivial or no value. In this rule, EPA Is proposing to exclude from the requirements of section 6(e) the manufacture, processing, distribution in commerce, and nee of PCB* created in closed manufacturing processes and controlled waste manufacturing processes, as they are defined by EPA in this proposed rule. The basis of this proposed action is that EPA has determined that these processes present de minimis risk to humans and the environment The proposed rule also requires that the persons who qualify for this exclusion and wish to take advantage of it certify that they qualify and maintain records of the basis for their determination. This proposal does not mean that the Agency believe* that dosed and . controlled waste processes are necessarily the only situations which present de minimis risks. In future' rulemakings, EPA will consider other types of processes which may also present de minimis risks. As discussed in "Background", EPA is developing a plan for rulemaking activities on other than dosed andcontrolled waste processes. EPA intends to consider these other procets situations and make a determination on the most appropriate regulatory approach. Regulatory options for other than dosed or controlled waste processes will tndude exduding other de minimi* risk situations identified at that time. EPA intends to submit the plan for dealing with other than dosed and controlled waste processes to the court on November 1.1982, During the course of discussions among ERA EDF, and industry immediately after the court's decision, doted manufacturing processes and controlled waste manufacturing processes were identified as probably presenting negligible risks. From the definitions of these process types, it logically follows that if no PCBs are released from a procets or If PCBs are released only to wastes that are destroyed or otherwise properly . disposed oL then the exposure and risk to humane and the environment from these processes must be extremely small and untSeasurapie. There would be no benefit from regulating the processes under section 8(e) since there could be no means of determining whether any regulatory actions could actually reduce human or environmental exposure. . The practical application of this concept requires an understanding of the way chemical processes work. Chemical manufacturing processes are generally made up of a series of unit operations. Each unit operation causes chemical and/or physical changes In the material passing through the process. These changes are brought about by the chemical reactions or various types of physical manipulations that are never one hundred percent effective or complete. In some processes which manufacture PCBs in low concentrations, virtually all the PCBs are destroyed in the process or are drawn off In a waste stream. However, there inevitably will be at least a few molecules of PCBs in every product or effluent that exits the process. Therefore. PCBs will be present in very low concentrations in products of these manufacturing processes. Since PCBs will be present in products (at very low concentrations), EPA must also address the processing, distribution in commerce, and use of these PCBs in this rulemaking. To establish a workable definition of processes subject to this exclusion, it is necessary for EPA to deflna. in a practical sense, the absence of PCBs in reteasgsto the envfrfinment from these processes. Specifically, EPA has to establish how the absence of PCBs will be defined in air emissions, water effluents, products, and wastes from closed processes; and how the absence of PCBs will be defined in air emissions, water effluents, and products from controlled waste processes. Further, it is necessary for EPA to determine appropriate methods for disposal of process wastes from controlled waste processes to insure that PCBs will not be released to the environment from disposal operations.- Therefore, after evaluating ways for determining the absence of PCB* in various releasee, EPA proposes to apply thin exclusion to: (1) PCBs generated in processes which have- no qrantifishU releases of PCBs (IT EPA's specified analytical technique were used) to products, air emissions, water effluents, or process wastes (closed processes); and. (2) PCBs generated in processes which hy nn qnsnHfiahlf reltaitt of PCBs (if EPAs specified analytical technique were used) to products, sir emissions, or water effluents, and all . other PCBs are disposed of in an EPA-r approved incinerator, or in an EPA* \ approved landfill or stored for such J disposal in accordance with certain J 0756054 TOWOLDMON0060207 Federal Busier / YeL V, No. 150 f Ttiesdwy, June 8, J3S2 / Proposed Rules 34979 specified criteria (contrailed waete ' processes). Bated on tSeOdA data. DA estimates that ^ to 5MM Poamda of puts per ytms cm^d be axuraptod from the provisions and prohibitions of section 6(e) By this exclusion. ead that on the order of several tbonaand . individual processee could be permitted to operate unregulated by sectioc 6(e). These estimates are derived from the available dale on proceeet which meet the definitions of closed and eontioUed waste processes as they appeared in the May 20,1061ANPR. The estimates ere expected to be upper limits, because this proposed rule defines closed manufacturing processes and controlled waste manufacturing processes in a more precise manner than they were defined in the May 20,1061 ANPR (these definitions are discussed under IVJJ. of this preamble). EPA is proposing to revise its definitions from those used la the ANPR because comments indicate that the previous definitions of closed and controlled waste processes were too vague and open to differing : interpretations. Thus, some processes categorized by CMA as dosed and controlled waste processes may not meet the definition of a dosed or controlled waste process as proposed in this rule. . This exclusion woohl permit the ' future generation of larger quantities of PCBs as impurities and byproducts in closed and controlled waste processes than are currently produced. However, EPA does not believe that the promulgation of this ride wffl result in a dramatic increase in the production of' PCBs in dosed and controlled waste processes because there is no known incentive for such an increase, as PCBs are formed as impurities and byproducts in very low concentrations and are not produced as commercial products. EPA is developing as enforcement strategy and compliance monitoring program to help to insure that only processes which qualify for this exclusion ednaDy operate unregulated under section 6(e). In addition, EPA intends to conduct periodic audita to . monitor the effectiveness of this ride. The purpose of conducting a regulatory evaluation (or *ndit)ts to determine if the rule is accomplishing its objectives. EPA invites comments oa the seed far such a program. Operators of PCB-genentiag V processes who have determined that their processes are closed or controlled waste processes, as defined by EPA in this proposed rule, and who want to take advantage of this exclusion an also required rjrnfv~that thv meet the exclusion, keep a record of the basis far the da toi faction, and make records and data available for review fay EPA upon rt qarst gA is act proposing in this rale to ^mcifcaHy Qit monitoring of PQ3 levels in releases from these processes or ft* sahesittsl to EPA of date sn PCB lands ia nlnim as conditions far qualifying isr tho excl--ion (see ****'-"**'--* wmder IVjG. of this prerarilel. Manuisg*TM-- Wve A option of theoretical * PCB levels fa rejc processes qualify tr to qualify, manufactures i demonstrate that PCBs would not ba quantifiable ta releases to other than controlled wastes if ths analytical technique specified in 176L62 were used. This technique Is capillary ges chromatography coupled to aa electron impact mass spectrometer (CGC/EIMS). EPA is developing guidelines to assist mnauiachiren in nwlrinf their determinations of whether processes are closed or controlled waste processes. The guidelines developed by EPA will address how to conduct a theoretical analysis and the needed sampling' frequency and the seed for representative sampling rf process streams if actual monitoring at PCB levels is undertaken. In addition, these guidelines will identify the type at quality assurance and quality central procedures which should bo developed aa an integral part of any program which involves actual monitoring at PCB levels. EPA will follow the pifaUttn-- when enforcing this rale. EPA expects that these guidelines will be cverieble during the public comment period for this rale, and their availability will be announced in al separate Federal Register notice.. ' In judytog whtW Aa pmpnssri definitions of closed menufartiaiag processes and controlled waste maaafactiirttm processes qualified ae da witfflmts situations. g^~rnfwkVrnri three factors: (1) The quantity of PCBs that is Mlroly in rriea*nd~ta> the environment from Hip-- pen----; (2) the potential maadtude of exposure and tbrfrequency of exposure to fOtha these process**; anti (3) the tieftafito fronrregulating [betejprocesse*. La. tbs likely reoecnons u exposers to PCBs thatmlghnetedl if these-Processes were reguterjtfuaoer sa&iTM rpa *Jjo considered whether the exch^*"" "f the | ~~ rasonable i TbeeValuetion of the issues sad factors described above, the basis tar EPA't findings, discussions of other options considered by EPA. and EPA's formal conclusion that these processes, as defined by EPA, pose de minimis risks to public health and the environment follow. B. Closed and Controlkd Waste Processes--Definitional hsues L Defining the absence ofPCBs in products, wastes, emissions and effluents. There are two general approaches the Agency could take to specify how the absence of PCB* ia to be determined In air emissions, water effluents, products, and wastes. First EPA could select a regulatory cutoff for air emissions, water effluents, products, and wastes at a level where it believe* PCBs cannot be practically detected at any lower concentrations. Under this approach, industry wankl be responsible far selecting analytical methods capable of detecting PCBs at the Agency's selected cutoffs. EPA might give some guidance to industry regarding analytical procedures. Second. EPA could specify the analytical methods and procedures to be used to determine the absence of PCBs. IfPCBs were absent from adl releases to ' air, water, and products (and wastes for closed processes), using EPA's methods and procedures, the process wonid be eligible for exclusion. Under this approach, EPA could give some general guidance concerning the PCB concentrations it expects its procedures to be capable of detecting. EPA is proposing the second approach, that of establishing an analytical technique. S'A chose this approach for several reasons. The -w Agency believes that the choice of analytical methods is one of the major sources of variability when attempting to detect PCBs. During the fall of 1981. CMA conducted a round robin experiment in which five different samples of material from processes . which manufacture PCBs as a byproduct were analyzed by eight different laboratories using a total of ten different analytical methods. The round robin experiment shows considerable variability in the results obtained by the ten different methods. EPA believes that specifying the analytical technique will eliminate one of the sources of this variability. EPA also believes that specifying a method is preferable to specifying a cutoff because the difficulty of analyzing products andwastes will vary . considerably among processee. If EPA specified a numerical cutoff tame companies would be able to easily detect PCBs ia their process streams below the cujpff sod other companies might have extreme difficulty detecting PCBs at the cutoff. In this regard, a numerical 5utoff could be considered 0756055 TOWOLDMON0060208 24980 Federal Register / Vol. 47, No. 110 / Tuesday, June 8, 1982 / Proposed Rules arbitrary. Specifying an analytical procedure mitigates this problem. The analytical system most often used to monitor PCBs includes a gas chromatograph with a suitable detector. The detector response is converted to an electrical signal which is recorded on a strip chart and the quantity of material present can be determined by measuring the area under the curve on the strip chart When only the carrier gas is passing the detector, the detector generates a small, slightly variable, electrical signal referred to as "background" or "noise." Detecting and confirming the presence of PCBe depends on the analyst's ability to measure an increase in the recorded electrical signal above this noise. The lowest concentration of a substance that aa analytical process can detect is referred to aa the limit of detection (LOD). A commonly used standard is that an LOD should be based on a ratio of at least three between the average magnitude of the electrical signal from the sample and the standard deviation of the electrical _ signal from the background. This is called the signal-to-noise ratio. The lowest concentration of a substance that an analytical process can reprodudbly quantify with* a calculated level of precision is referred to as the limit of quantification (LOQ). A commonly used standard is that an LOQ should be based on a signal-to-noise ratio of at least ten. At concentrations near the LOD, It is possible to detect that some chemical compoimd that might be a PCB is present, but it may be impossible to confirm its identity. False negatives and false positives are common. A PCB concentration at or near the LOQ may be needed to confirm the Identity of the chlorinated biphenyL For this reason, EPA proposes that the absence of PCBe be defined as a concentration of PCBs less than the LOQ for the proposed analytical methods. This establishes aa easily enforceable condition for Judging eligibility as a closed or controlled waste process. * ' EPA is faced with the problem at deciding the level of sophistication that should be used an analytical techniques; As more sophistication is required for . measuring PCBs in very low concentrations, the cost of analysis Increases and the availability of facilities and equipment to conduct analyses decreases. Because determining the absence of PCBs In products, air releases, and water releases is critical under this exclusion, the analytical methods selected and referenced by EPA for quantifying PCBs in these media need to be readily available, have a cost that is reasonable micrograms per liter for one liter of relative to the environmental risks of waste water, and 10-100 micrograms per PCB exposures, result in sufficiently 100 grama (0.1-1 ppm) in a 100 gram reproducible data, and have adequate organic process or product stream. sensitivity. EPA considered a number of The total amount of unquantified PCBs which could be released from a techniques for extraction, cleanup, and - process will vary, depending on the determination of PCBa in samples. The number of specific isomers present in a analysis is extensive and is therefore particular sample. For example, if a not reproduced here. It is contained in product contains ten different isomers, the support document, "Methods of present at concentrations slightly below Analysis for Incidentally Generated PCBs-Literature Review and Preliminary Recommendations," which is available 1 ppm. up to 10 ppm PCBs could be released in this product and yet be unquantifiable by EPA's specified for review and comment ' The proposed method, outlined in I 761.82 and described in "Methods of Analysis for Incidentally Generated PCBs-Literature Review and Preliminary Recommendations," does not ose specific extraction protocols or cleanup techniques, but rather, allows the individual laboratory to develop the necessary procedures. This Is because these procedures are media dependent EPA is, however, specifying the method of analysts it will use in enforcing this exclusion. The method specified by EPA la capillary gas chromatography ooupled to an electron impact mass spectrometer (CGC/EIMS). CGC/EIMS systems are readily available. CGC/EIMS is cost- effective for multimedia analysis since separation and cleanup procedures for each media will ultimately provide an extract compatible with CGC/EIMS systems. While the reproducibility of the specified method remains to be documented for PCBs, available data from the analysis of other compounds suggests that this method does provide reproduable data. Further, CGC/EIMS does provide confirmatory evidence for PCBs, if present, at a moderate cost and at an acceptable level of sensitivity (see below). EPA expects the method to supply reliable data of known qqality if users implement an appropriate and documented quality assurance program. The sensitivity of the EPA specified method has been estimated by EPA and is discussed below. The class of PCBa is method. Similarly, if a product contains 70 isomers at concentrations slightly below 1 ppm, up to 70 ppm PCBs could be released in this product EPA does not anticipate that samples will frequently contain greater than 70 isomers. Rather. EPA expects that in most cases samples will contain considerably leas than 70 isomers. EPA has considered other detection systems such as electron capture detectors (ECD) and negative ion chemical ionization mass spectrometry (N1QMS). ECD was found to be very sensitive, readily available and of moderate cost It is, however, inappropriate because it does not . provide confirmatory evidence that the residues detected are PCBs, and not other halogenated organics that are likely to be present in many samples. N1QMS was found to provide confirmatory evidence, but it is inappropriate due to high cost and limited availability. EPA believes that its approach to analyzing for PCBs satisfies all the- requirements of an acceptable method. EPA requefts comments on this proposed approach, especially in the areas of confirmability, sensitivity, cost and availability. 2. Other options considered by EPA for defining the absence ofPCBs in emissions, effluents, products and ' wastes, (i) "No quantifiable" PCBs. EPA also considered defining the absence of made up of 209 individual chemical PCBs as no quantifiable PCBs in air - compounds. Individually referred to as chlorinated biphenyls. Using EPA's releases, water releases, products, or wastes using any available analytical referenced method, each separate technique. This option was not selected resolvable peak or a gas chromatograph principally because of the uncertainty it may represent a single chlorinated would cause in the regulated community biphenyl, or it may represent all of a and problems in assuring compliance. In group of chlorinated biphenyls. the absence of specified analytical CGC/EIMS is capable of quantifying procedures or specific numerical limits, PCBs at the level of ten hanograms per a requirement for "no quantifiable resolvable gas chromatographic peak PCBs" in air releases, water releases, (see support document, "Rationale for products, and wastes would result in the Estimate of Level of Quantitation for use of many different procedures with GC/MS" for discussion). Per peak, this vastly different quantification limits. level roughly corresponds to an average This is particularly true for products and of 1-10 micrograms per cubic meter for waste streams where the difficulty of ten cubic meters of stack gas, 10-100 analysis varies more than in the case for 0756056 TOWOLDMON0060209 Federal Register / Vol. 47, No. 110 / Tuesday, June 8, 1982 / Proposed RuJes 24981 til or water. In addition, state-of-the-art environment. Since EPA is proposing to as they appeared in the May 20.1981 limits of quantification for PCS* will - exclude controlled waste manufacturing ANPR. An upper estimate from CMA change over Him with technological processes from tbs provisions of section data and CMA and. EPA assumptions innovation; thus, a floating limit would 0(e) based on the de minimis risk " about the data (see unit HI) suggests that occur. All of these factors would hinder principle, EPA must be reasonably up to 56,000 pounds of PCBs per year uniform implementation and confident that the wastes from could be generated in these processes. enforcement of the rale. controlled waste processes are disposed In this rule, EPA is proposing to define (ii) Not spedficolly excluding dosed . of in a manner which will result in closed and controlled waste processes manufacturing processes. EPA negligible environmental contamination. by specifying the absence of PCBs in considered excluding closed processes Therefore, EPA is proposing to specify releases and specifying appropriate only if all process wastes were acceptable methods of disposal for incinerated, disposed of in an ESA- wastes from controlled waste processes. approved landfill, or stored for later . EPA is proposing that eligibility for incineration or landfilling. The reason exclusion as a controlled waste process EPA considered this alternative is that it requires iprtnpwitinn by a facility has been suggested that it may be ' approved under | 76170, landfilling in a* particularly difficult to identify landtiil approved unoer 178175, or universally applicable analytical storage-for Incineration or landfilling in methods for waste streams. comrrttHgce'witn the criteria specified in The CMA survey indicates that only | 761.65(b)(1). about 3 percent of the processes ' . The ui tails speufied in f 781.70 . Identified by its members were closed require that the incinerator used for processes. Consequently, EPA believes destruction of PCBs be approved by the that if this approach were taken, no EPA Regional Administrator and that it more than a few hundred individual meet certain standards related to processes would be affected nationwide. effia'ent combustion. Incineration in This option was not selected because compliance with these standards has EPA concluded that reasonable ____ been shown by extremely sensitive tests analytical procedures for detecting PCBs to result in essentially no release of in waste streams could be established PCBs to the atmosphere. . and that manufacturers utilizing closed The criteria specified in f 781.65(b)(1) processes should be able to benefit from for the storage of PCBs require that - the exclusion without having to storage facilities meet standards incinerate or landfill wastes possibly including adequate flooring with containing no PCBs. continuous curbing, no drain valves or . EPA requests comments on die floor openings, and construction of alternatives presented in this section floors and curbing with impervious and any other alternatives that may be materials. appropriate. EPA specifically invites EPA already has in effect a Disposal comments and data on the extent to and Marking Rule (43 FR 7150), which which this proposal will affect persons requires PCBs in concentrations over 50 involved in the manufacture, processing, ppm to be disposed of in accordance distribution in commerce, ana use of with the criteria prescribed under PCBs. EPA is particularly interested in ii 781.70,78175, and 78185. These are receiving comments on the approach the same disposal criteria being selected, i.e., to specify analytical proposed for controlled waste techniques for quantifying PCBs in processes. Consequently, this proposal process streams. of requiring stricter criteria for disposal 3. Determining appropriate methods of wastes than was implied in the ' for disposal. The May 20,1881 ANPR definition of controlled waste process in defines acceptable methods of handling the ANPR will effect only persons using wastes from controlled waste processes processes which release PCBs to waste as incineration, disposal in EPA- streams at concentrations between the approved chemical waste landfills, and limit of quantification and 50 ppm. storage for such incineration or EPA invite* comments and data on landfilling. An EPA-approved chemical . die extent to which this proposal or methods of disposal. Therefore. EPA anticipates that fewer processes may actually qualify for exclusion than was suggested by EPA calculations based on the CMA data and extrapolations from those data to the entire chemical industry. EPA anticipates that, based on current production, less than 56,000 pounds of PCBs per year would actually be excluded from the provisions of section 6(e) under this proposed . exclusion. It is theoretically impossible to preclude the release of some PCBs from ' manufacturing processes in which PCBs are generated. Therefore, extremely small quanitites of PCBs will be released ' from closed and controlled waste processes to the environment, as free PCBs, contained in air emissions, water effluents, wastes, and products. Actual environmental releases from products are expected to be even less, since the PCBs in many products are bound in solid matrices (i.eM paints and polymers). Although wastes from controlled waste processes will contain higher levels of PCBs, the proposed requirements for handling these wastes will prevent significant releases to the environment Workers may be exposed to PCBs that are produced in closed and controlled waste manufacturing processes through a variety of activities involving manufacture, processing, distribution in commerce, and use. Exposures may occur through: (1) Direct handling of products, wastes, or other materials containing low level PCBs, (2) handling of containers for these materials; (3) maintenance of equipment and (4) handling of laboratory samples containing PCBs. EPA evaluated occupational exposure waste landfill is a facility approved alternate requirements for incineration, to PCBs by first identifying six generic ft under 176175. However, EPA did not. landfilling, and storage will affect activities which are likely to occur specifically define ''incineration'' or persons involved in the manufacture, during routine operations in chemical "storage for Incineration or landfilling." processing, distribution in commerce manufacturing plants, and then After further consideration, EPA . and use of PCBs. calculating the anticipated exposure to f believes that additional clarification of the acceptable methods of disposal is needed under the definition of a controlled waste manufacturing process. . C The Likely Magnitude ofReleases of PCBS and Exposure To PCBs From Closed and Controlled Waste Processes PCBs from these activities. These activities are: (1) The sampling of process streams, (2) the cleaning of reactors, (3) removing spent filters, (4) . Certain methods that may meet the 1.Routine operations. As discussed repairing equipment (5) removing still general definitions of "incineration" and earlier, CMA speculates that many bottoms, and (6) handling, storage and "storage for incineration or landfilling" processes may meet the definitions of loading of products. EPA anticipates could result in releases of PCBs to the closed and controlled waste processes that the handling, storage and loading of 0756057 TOWOLDMON0060210 24982 Fedora! Register / Vol. 47. No. 110 / Tuesday, June 8, 1962 / Proposed Rules products In a continuous operation will result In the lowest levels of exposure, while cleaning reactors in a batch operation will result in the highest levels of exposure (see support document entitled "Occupational Exposure to Inadvertently Produced PCBe" for more details). Industry representatives have commented that the chemical industry employs proper protective clothing and good management practices to protect workers from exposora to process components. Safety glasses, gloves, and long-sleeved shirts were reported as being generally used when contact with a toxic or corrosive chemical may occur. In addition, comments were received that indicated that additional protection, including splash goggles, shields, gloves, and protective outer clothing is usually required during waste handling operations. EPA has concluded that exposure levels during routine operations are not expected to result in significant exposure because of measures already instituted in the industry to reduce exposures. EPA specifically requesta additional comments on exposure to PCBs, particularly the degree of absorption at PCBs that might occur during routine operations in chemical manufacturing plants. ' 2. Accidental and unplanned releasee. Accidental releases may occur when ' pipes, lines, or hoses rupture. Unintentional spills can occur during the transfer and transport of products and wastes. These unplanned events may expose unprotected workers, the general public, and fish and wildlife to higher PCS levels than routinely occur during normal plant operations. EPA has little information from industry indicating the frequency of unplanned events, and die likely releases during these events. However, industry representatives have contended that scheduled maintenance . activities and process engineering and design considerations mfntmtv me potential for accidental release*. Comments indicated that it Is in the best interest ofcompanies to work to . minimize the loss of process components from accidental releases, because large or frequent accidental releases would seriously harm production and profitability. EPA'i Independent exposure assessment confirms this, as major accidents (resulting in large releases or process componete) are expected to be rare (on the order of onco every sixty yean per facility). EPA requests comments and data ok (1)The types of accidental releases that might occur and their frequency. (2) the likelihood of releases of PCBs to the environment from such accidents, and (3) measures being taken by Industry to prevent accidents or to control releases and exposures when accidents do occur. D. Conclusion: Processes Covered by This Pule Present de Minimis Risks . TSCA section 6(e) specifically bans the manufacture, processing, . distribution in commerce, and use of PCBs in other than a totally enclosed manner. The adverse effects of PCBs were described in considerable detail ia various documents which were part of the rulemaking record for the May 31, 1979 rule. While substantial comments have been submitted to EPA rebutting the conclusions made' with respect to the toxidty of PCBs, the Agency does not agree that this information proves that PCBs do not pose any serious risks to human health or the environment. EPA believes however, that the risks posed from exposure to PCBs are reduced aa exposure to PCBs is reduced; and. that an unmeasurable level of exposure to PCBs can be considered to pose da minimi* risks to public health and tho enviroameat To be eligible for exclusion from the provisions of section 6(e). processes most meet EPA's definitions of closed or controlled waste manufacturing processes This means that releases of PCBs in products, air emissions, and water emissions an not quantifiable if EPA's specified analytical technique were used. For dosed manufacturing processes, releases of PCBs In wastes also must not be quantifiable by EPA's specified analytical technique. EPA abo is proposing to require wastes from controlled wsste processes to bo disposed of by incineration In a facility approved under f 761-70; landfilMng in a landfill approved under 761.75; or stored for incineration or landfilling ia compliance with the standards and requirements prescribed In | 761.85(b)(1). ftedadmg releases of PCBs above the limits of quantification will Insure that only negligible releases of PCBs occv. Further, disposal of wastes hi compliance with the above standards will prevent the release of PCBs in anything but negligible quantities. EPA does not believe that any significant harm will result from releases of PCBs to the environment or exposure to humane at unmeasurable levels. Since the releases are not measurable by reasonably available methods, 11 would be Impossible to determine whether regulation hed any effect on reducing the releases. Also, EPA does not know of any reasonable way to regulate releases of PCBs below measurable levels in order to reduce the releases further. Consequently, there would be no gain In protecting the environment or public health by attempting to regulate unmeasurable levels. Finally, EPA's upper estimate of the amount of PCBe which currently would be excluded from the prohibitions and requirements of section 6(e) by this exclusion is 56,000 pounds of PCBs per year. Of the tiny fraction of these PCBs that are not destroyed in the process or handled as a controlled waste, some will be bound in products, further limiting the actual quantity of free PCBS that are likely to enter the environment Although this proposed rule would not prevent these amounts from increasing, EPA is not aware of any reason why these quantities should increase significantly. It Is possible that some companies may institute engineering modifications to their processes to qualify for the exclusion. This would, however, benefit public health by reducing overall releases of PCBs to the environment The amount of PCBs expected to be released annually from these excluded processes Is only a tiny fraction of the extimated 150.000,000 pounds of PCBs that currently exist in the environment as freePCBa. Therefore, EPA finds that if releases of PCBs from closed and controlled wastes processes (excluding controlled wastes) are unquantifiahle by EPA's specified analytical techniques, and controlled wastes are disposed of aa specified by EPA, then these processes represent de minhwi* risk situations and should not be subject to the prohibitions and other provisions of section 6(e). & Determination ofNo Unreasonable Risk EPA has concluded that there would be no measurable benefits to public health or the environment by regulating closed and controlled waste processes (as defined In this rule) under section 6(e) of TSCA. Therefore, as previously noted, these processes are eligible for tnrrlwimi ihiXpt tKes Am mwiimii principle. Nonetheless, the Agency has also considered whether closed and controlled waste processes present an unreasonable risk to human health or . the environment To determine whether a risk la unreasonable. EPA balances the probability that harm wifi occur from the activity against the advene effect on society from regulation, hi making a determination of whether aa unreasonable risk to present from theeq^, processes, EPA considered the following factors 1. The effects of PCBs on human health and the environment. 2. The magnitude of PCB exposure to humans and the environment 0756058 TOWOLDMONOQ60211 Federal Register /`VoL <7, No. 110 / Tuesday, June 8, 1982 / Proposed Rules 24983 S. The benefits from products commented that research programs to containing PCBs, the availability of study ways to reduce incidental PCB eubstitutes, and the ability to prevent formation are very costly and have met the formation of PCBs. with limited success. CMA provided an 4. The e&tfomic impact resulting from' example of a process adjusted to reduce the rule upon the national economy, formation of PCBs to below SO ppm, and mall business, technological estimated that the cost of this project innovation, the environment and public was on the order of $800,000. ' health. Although TSCA does provide a . After considering all available mechanism for obtaining relief from the information, within the context of the total baa of PCBs, industry has factors listed above. EPA finds that commented that the statutory process excluding closed and controlled waste . for obtaining an exemption is processes presents no unreasonable risk unworkable for the many operations to human health or the environment that manufacture, process, or distribute This finding is baaed on the reasons in commerce PCBs in low discussed below. ' concentrations. Since TSCA requires a 1. Health and environmental effects company to obtain an wnnl and exposure to PCBs. EPA has exemption industry representatives determined that exposure to PCBs from indicated that the uncertainty dosed and controlled waste processes is associated with knowing whether they so low aa_to be reasonably would be able to continue operations unquantifiable. Since the risks posed and the large cost of submitting petitions from exposure to PCBs decrease as each year would be a burden A quick levels of exposure decrease. EPA survey of companies which filed believes that exposure to PCBs at . exemptions with EPA in the past nonquantillable levels from dosed and showed that the annual costs of controlled waste processes gases de developing the information required by minimis risks to public health and the an exemption petition plus the cost of environment filing the petition may cost between 2. Benefits ofproducts generated in $16,000 and $128,000 per proeesf. closed and controlled waste processes, Although EPA does not lmow precisely the availability ofsubstitutes, and ' how many processes meet the definition economic impacts. If the ban on all of closed and controlled waste manufacturing, processing, distribution processes, if 500 processes were eligible, in commerce, and use of PCBs was made the avoided cost of submitting petitions effective for all dosed and controlled for exemption could range from $8 waste processes, there could be a major million to $63 million per year. These disruption of the chemical industry and estimates will vary depending upon the several other industries in the United actual number of processes eligible for States. Since there could be a large the exclusion. Administering exemption number of controlled waste processes, petitions for closed and controlled an immediate ban could cost billions of waste processes could require extensive dollars. An immediate ban could disrupt EPA resources. -the manufacture of a wide variety of This rule has no significant negative products induding paints, varnishes, economic impact since it imposes no enamels, agricultural chemicals, additional burdens but rather, avoids . adhesives and sealants, printing ink, some of the burdens imposed an . plastic materials, drugs, and soaps and industry by the prohibitions of section cosmetics. Such products have great 6(e). As discussed earlier, EPA is societal value, and a ban of this nature proposing in this rule to require would create great hardship for the public and industry due to the manufacturers who operate closed and controlled waste manufacturing unavailability of these products and processes and who desire exclusion to would have a severe economic impact certify that their processes are closed or Should such processes by subject to the controlled waste processes. EPA is section 6(e) ban, all manufacturers proposing to give manufacturers the utilizing dosed and controlled waste option of conducting a theoretical manufacturing processes which generate analysis to demonstrate that PCBs . PCBs as byproducts would be required would not be quantifiable by EPA'a to conform with the prohibitions and specified technique in releases other requirements of section 6(e). Industry than to controlled wastes, or of actually has commented that in general, monitoring releases for PCB levels. EPA substitutes are not available for estimates the cost of certification products contaminated with low level without actual monitoring of PCB levels PCBs at the same or equivalent costs as in releases to be on the order of S&4JOO PCB contaminated products, and that per process per year. EPA estimates the processes cannot be modified to prevent cost of conducting a theoretical analysis the formation of any PCBs. CMA has to be on the order of $800 per process. If actual monitoring of PCB levels is undertaken, using the EPA-spedfied method. EPA estimates the costs of monitoring to range between $ann and $2,000 per sample. Total costs per process range from $1,200 to $72,000, depending on the frequency of sampling and the actual costs of testing (see. support document entitled "Cost Analysis for the Proposal to Exclude Closed and Controlled Waste Processes from the PCB Ban" for details). This exclusion substantially reduces the cost to industry associated with the'expense and problems of annually developing, analyzing, and preparing petitions for exemption from the section 6(c) ban and the cost of EPA of processing these petitions. F. Relationship of the ProposedRule To Other PCB Rules 1. Disposal and marking rule. The Disposal and Marking Rule, published in the Federal Register of February 17,1978 (43 FR 7150). as Part 761 of Title 40 of the Code of Federal Regulations, requires that when PCBs and PCB Items are removed from service, disposal be in accordance with specific criteria. Briefly, PCBs in concentrations below 50 ppm are not required to be disposed of in any spedal manner; liquid PCBs in concentrations between 50 ppm and 500 ppm are required to be disposed of in an Incinerator which complies with certain standards, or in a chemical waste landfill or in a high efficiency boiler, non-liquid PCBs are required to be disposed of in an incinerator which complies with certain standards or in a chemical waste landfill; and liquid PCBs in concentrations at or above 500 ppm are required to be disposed of in an incinerator which complies with certain standards. This proposed rule has no effect on the existing marking and disposal regulations. It simply excludes PCBs generated in controlled waste manufacturing processes from the section 6(e) ban when ail PCBs generated are handled in ways . prescribed under the existing disposal rule. 2. Regulatory exclusion at SOppm. The PCS Manufacturing, Processing, Distribution in Commerce, and Use Prohibition rule, published in the Federal Register of May 31.1979, (44 FR 31514), as Part 761 of Title 40 of the Code of Federal Regulations basically prohibited the manufacture, processing, distribution in commerce and use of PCBs in concentrations above 50 ppm in other than a totally enclosed manner. As discussed under the Background unit in this preamble, this exclusion of PCBs in 0756059 TOWOLDMONOQ60212 24964 Federal Register / VoL 47, Me. 110 / Tuesday, Jane t, 1962 / Proposed Rnlee concentrations below SO ppm wee successfully challenged by the . Environmental Defenae Fund. The ocwrt granted a stay of mandate with respect to the SO ppm cutoff, and persona manufacturing, processing, distributing. in commerce and using PCBa in concentrations below 50 ppm ware permitted to continue these activities. The initial stay of mandate waa scheduled to expire oo October 13,1262. However. In its report to the court an uncontrolled PCBs, EPA requested an extension of this stay of mandats until December 1.1982. Prior to that time, EPA intends, to submit a plan to the court for rulemaking on uncontrolled PCBs. EPA anticipates that its plan will include a schedule for rulemaking for uncontrolled PCBs and a request for an additional extension of the stay of mandate until the nilmwking is completed. C. Determining Eligibilityfor Bxcluaiom Persons producing PCBs as impurities or byproducts in manufacturing processes need a means of determining whether they are eligible for this exclusion. Further, EPA Is naturally concerned that only processes which meet the proposed definitions of closed or controlled waste processes are permitted to operate unregulated under section 0(e). . To accomplish these objectives H*A is proposing an amendment to Subpart J which would require that persons who produce PCBs and who consider - themselves eligible for the exclusion certify that their processes meet EPA's definition of a dosed or controlled waste process, Le- PCBa are not quantifiable in releasee from these processes (in other than controlled wastes) by the EPA-spedfied analytical technique. They would be required to develop and maintain records an thn basis for their certification. Manufacturers are given ths option of developing a theoretical assessment which demonstrates this, or of actually monitoring PCS levels to support certification. If actual monitoring is undertaken, those persons are required to maintain a record of any analytical. data that they obtain on PCB levels in the processes at in releases from their processes. If monitoring is elected, thie proposed rule does not require that ths . EPA-spedfied method be used. Any technique can be used, but the standard that must be met is still that PCBs are not quantifiable In releases (except in controlled wastes) if the Q>A-spedfied technique were used. This section . specifies the formet for such a self' certification and the recordkeeping . necessary to support this certifiesttoa. The primary purposes of this self ' stream. EPA will attempt to develop a certification program are (1) for persona sampling procedure that uses a to determine if the rule is applicable to sequential sampling schema. tK<n and (2) to aid EPA in monitoring This approach should result (n a compliance. This approach would considerable savings over standard provide reasonable assurance that only statistical sampling methods without prooessee which actually meet thn adding to the riaks of making incorrect definitions for exclusion operate decisions. Sequential sampling is a unregulated under section 6(e). By being procedure where, unlike other statistical able to self-certify, industry avoids the methods, tha sample size Is not fixed in costs of petitioning for exemptions advance. The sequential sampling under section a(e). procedure indicates, after every sample The self-certification process begins or group of samples Is analyzed, with compiling data to show that a . whether sufficient samples have been process meets EPA's definition for gathered to make a decision or whether exclusion This may indude actual additional samples are needed. On the monitoring of PCB levels in releases, or average, fewer samples are required for It may oonsist solely of preparing this procedure than with other methods. information for use in a theoretical The sequential sampling scheme used by assessment EPA considered EPA will insure that the decision that establishing rigid requirements for the the level of PCB concentration exceeds a type of data needed to support a l quantifiable level will be incorrect for manufacturer's determination that a approximately 5 percent of the streams process Is closed or controlled wests sampled (95 percent confidence level). manufactnring process. EPA considered EPA believes that a high level of requiring monitoring of releases from confidence is desirable to insure that processes to air, water, products, and incorrect decisions that a process should wastes (of dosed processes). EPA be excluded from the ban will occur evaluated tha feasibility of specifying infrequently. EPA specifically requests die frequency of sampling and places for comments on the appropriateness of e samplingJa manufacturing facilities. 9S percent confidence level for this ' EPA determined that it was not decision. feasible to develop and propoaa a Tha guidelines developed by EPA can detailed monitoring program of bro6d be used as reference tools by applicability because of the extrema manufacturer! when they evaluate their variability among processes and processes to determine if they are manufacturing facilities. Rather, EPA is eligible for exclusion. They will be used proposing to allow manufacturers to by EPA in monitoring compliance with select either theoretical assessments or this rule. EPA expects that the actual monitoring of PCB levels to " guidelines will be available during the support certification. EPA intends to public comment period to this rule. EPA develop guidelines to assist persons tai intends to announce their availability the evaluation of manufactnring through a Federal Register notice. processes for eligibility under me dosed EPA considered requiring reporting and controlled waste process exclusion. data to the Agency on a semi-annual or These guidelines will Identify processes an annual basis. EPA also considered likely to produce PC35 and specify ths requiring reporting one time with re types ana nature of data that would be certification being required upon - considered acceptable to support a significant process changes. EPA is determination that a process is dosed or proposing that no reporting be required. controlled waste process. These With no requirement to report to EPA guidelines will address how to prepare a that certain processes qualify for theoretical assessment es weQ as now exclusion, some processes may be to conduct actual monitoring of PCB mislabeled as qualifying for this levels In releases. In addition, these exclusion when in reality the guidelines will describe the type of ' manufacturer should be petitioning for qualify assurance and quality control an exemption. To help reduce the procedure* which should be developed likelihood of this occuring. EPA le es an integral part of any program which developing an enforcement strategy. involves actual monitoring of PCB EPA's enforcement strategy will include levels. identifying procesees which are likely to A determination that PCBa are absent generate PCBa aa impurities and by actual monitoring of PCB level* must byproducts. EM intends to use the take into account that statistical petitions for exemption, among other variability in analytical results which sources of information, to identify will always occur. Recognizing that generic processes which are likely to than will be variation results of a series generate PCBe, This information would at taken from e particular accompany the analytical guidance to 0756060 TOWOLDMON0060213 , Federal Register / VoL 47, No. 110 / Tuesday, June 8. 1962 f Proposed Rules 24385 be distributed for this rule. After controlled waste processes (or petition developing the enforcement strategy, for exemption). 11 would require EPA to EPA will then determine if companies expend substantial resources reviewing manufacturing similar products have die applications for exclusion. By setting petitioned for exemptions. If petitions up such an certification nave not been submitted by particular procedure, in effect industry and EPA manufacturers, EPA will examine would be subject to monitoring, company records of persons who claim reporting, and reviewing requirements their processes are closed or controlled similar to those incurred under the waste processes. Through these means, regular exemption process. One of the EPA believes it can effectively assure main reasons for this rule is to relieve that the exclusion is not being abused. manufacturers and processors of the With the proposed approach, burdens imposed by an exemption manufacturers would identify processes process when the potential exposure to which they believe generate PCBs as PCBs from their processes is very low. impurities or byproducts, determine if However, this approach would probably the processes are dosed proceases or provide the greatest assurance that only controlled waste processes, end piece companies that are truly eligible for the data and records of their determinations exclusion operate unregulated under in records at tbe facility. Should section 6(e). manufacturers periodically undertake 2. No documentation. EPA also monitoring of PCB levels in processes or considered not requiring recordkeeping in releases from the processes, these by manufacturers utilizing what they data would also be retained. EPA is consider to be dosed or controlled proposing to require that such records waste manufacturing processes. Under be maintained for seven yean, or for at this alternative, manufacturers would leaat three yean after the particular not be required to maintain any records process being used at die facility ceases of their determinations that processes operations, whichever is shorter. operating at their fadlities were closed. Farther, EPA is proposing to require that or controlled waste manufacturing processes be reevaluated and that processes. This alternative eliminates new certification be filed upon the costs and burdens associated with significant process changes that documenting determinations that invalidate the previous certification. A processes are dosed or controlled waste significant process change is one which processes. ' is likely to change the concentration of Clearly. with no requirement to .. PCBs in releases from the prooesees document determinations that certain (except in controlled wastes). processes qualify for exclusion, many In addition, EPA intends to develop processes may be automatically labeled and conduct an audit program to aa dosed or controlled waste processes monitor the effectiveness of this rule. and operate unregulated under section - The purpose of this program la to 6(e). Further, a large amount of determine if the rule has accomplished resources would have to be expended its objectives, and to identify potential by EPA to verify manufacturers claims areas where revisions or modifications that processes generating PCBs without are needed. specific exemptions are dosed or Other alternatives that EPA controlled waste processes. This is . considered but rejected are discussed because in many cases EPA would have below. . to develop a verification strategy 1. Certification by SPA. Under this tailored to individual prooesees, and . alternative, every company desiring to ' there would be no records for EPA to classify a process as a doted or review to determine how the company controlled waste process would be concluded that it was eligible far the required to submit theoretical or exclusion. It would be extremely analytical data to EPA with a request . difficult for EPA to identify anyone but for certification aa dosed or controlled tbe most flagrant violator!. It is very . waste process. After EPA reviewed the likely that companies would not spend submitted data and the request it would much effort to ensure that they actually send the company a determination of met the criteria for exdusion since the eligibility for exclusion from the likelihood of being identified as not requirements of section 6(e) under the dosed and controlled waste process complying with the rule would be very mail. ` exclusion. This approach would be very costly and burdensome to industry and EPA. It would require tbe development ft. Discussion ofAnalyticalMethodFor Detecting PCBe of data and submittal of data to EPA Section 761.82 designates capillary gas from everyone in the chemical industry chromatography coupled to an electron and other industries who generate PCBs impact mass spectrometer (CGC/E1MS) to prove that they are dosed or at the EPA specified analytical technique for quantifying PCBs in air emissions, water effiuents and product/ process streams. CGC/EIMS is the analytical technique ipedfied under the definitions of closed manufacturing process and controlled waste manufacturing process. To qualify for . the closed and controlled waste process exclusion. PCBs must not be quantifiable by this technique in releases to air, water, and products (and wastes from closed processes). Although actual monitoring of releases is not required as a condition for exclusion (theoretical analyses are acceptable), and this method is not required if monitoring is elected, if actual monitoring is undertaken, manufacturers may wish to use the method specified in f 70182 to insure that they are in compliance with the rule. EPA will use this technique in conjunction with the yet to be published guidelines to determine whether processes are dosed or controlled waste processes. 1. Chemical analytical methodology. . True confirmation of chlorinated biphenyls (PCBs) in specimens which may contain other chlorinated aromatic compounds can reliably be accomplished by capillary gas chromatography (CGC) coupled to mass spectrometry (MS). In order to obtain the selectivity to use this analytical technique, specific separation, extraction, and cleanup steps are a necessary part of the chemical analysis process. There are many analytical procedures for separation, extraction, deanup, and detection which can successfully be used to indicate the presence of PCBs. These methods are useful in identifying tbe presence of materials which may require the confirmatory analysis outlined in 176182. For enforcement purposes EPA will use the analytical approach described in 176182. 2. Quality assurance plan for measurement of incidentally generated chlorinated biphenyls (PCBe). An . integral part of CGC/EIMS analysis is the quality assurance program (QAP). QAPs insure the integrity of the data produced. A QAP includes the following: (1) History and disposition of samples, (2) sampling and sample collection procedures and (3) extraction and instrumental analysis procedures. A QAP documents how a laboratory intends to demonstrate its capability to produce data of acceptable quality. A QAP is essential for establishing the validity of the analytical data generated. For enforcement purposes EPA will use CGC/EIMS in conjunction with a QAP 0756061 TOWOLDMONOQ60214 24968 Federal Register / VoL 47. No. 110 / Tuesday, June 8, 1982 / Proposed Rules to verify the accuracy of the data generated. 3. Guidelines. The guidelines EPA is developing will include guidance on: (1) Sample collection and homogenization of the sample, (2) addition of surrogate compounds to the sample, (3) extraction and cleanup, (4) concentration or dilution of the extract (5) analysis of the final extract (B) reporting the results of the chemical analysis as specific PCB isomers or total PCBs, and (7) developing a QAP. Sample collection should be representative of the process to be characterized. Increased variation in the components of the process will increase the necessity to sample more frequently or to composite samples taken concurrently from several locations. The samples will then pass through a decision tree wherej>ertinent procedures in the analytical method will be selected, based on die nature of a specific sample. As an example, for the homogenization step, aqueous samples free of suspended or settled solids would pass on to the extraction step. Aqueous samples with suspended matter would be stirred during subsampling and extraction. Aqueous samples with settled material, which could not be stirred into a suspension, would require pulverization of the solids and then could be treated as the aqueous sample which contained suspended matter. In the guidelines, other portions of the decision tree will be described for non-aqueous samples and for the other steps in analyzing for PCBs. V. Summary of Issues EPA specifically requests comments, data, and information relevant to: 1. The data presented in the CMA survey. 2. The appropriateness of excluding closed and controlled waste processes from the section 6(e) ban including EPA's rationale that closed and controlled waste processes pose de minimis risks to public health and the environment; and that the benefits of allowing these processes to be excluded outweigh the de minimis risks posed. . 3. The need to specify criteria far determining the absence of PCBs in products, air emissions, water discharges, and wastes to define adequately processes subject to the exclusion; the desirability of one . criterion for all releases or separata criteria for air, water releases, products, and wastes of closed processes; the suitability of the proposed analytical method for purposes of judging whether a process should be eligible for the exclusion. In particular, EPA seeks Information relating to the effect that the proposed method would have on persons involved In the manufacture, processing, distribution in commerce and use of PCBs. - 4. The appropriateness of using limits of quantification versus limits of detection for defining the absence of ' PCBs in releases from processes. 5. The appropriateness of requiring controlled wastes to be sent to facilities In compliance with standards in S S 791.7a 781.75, and 761.65. In particular, EPA seeks information relating to the effect that this requirement would have on persons disposing of waste from controlled waste processes, and on the environmental/health risks of not disposing of PCBs in this manner. 6. The need for a program whereby manufacturers demonstrate that their processes do qualify for exclusion; the desirability of a self-certification program versus one where the manufacturers report to EPA and the Agency determines whether they qualify. In particular, EPA seeks information relating to the effect that ' self-certification or other programs would have on persons who inadvertently manufacture PCBs, and on the problems or risks associated with not requiring certification and * recordkeeping. 7. The suitability of allowing manufacturers to use best theoretical analyses in lieu of actual monitoring of PCB levels. In particular, EPA seeks information relating to the effect that requiring monitoring data or theoretical analyses would have on persons inadvertently manufacturing PCBs. 8. The retention time for records (7 years or 3 years after a process ceases operation, whichever is shorter). 9. The coat and economic Impact of this exclusion policy. Specifically: a. The costs of EPA's recommended analytical technique for determining the absence of PCBs, including sampling and storage costa. _ b. The costs of recordkeeping and reporting which might be required for eligibility for the exclusion. e. The availability of testing . equipment to perform testing in-house and/or the availability of outside laboratories to perform tests. d. The costs to manufacturers of performing "best theoretical analyses'* in lieu of actual monitoring of PCB levels. e. The costs of incinerating wastes in EPA-approved incinerators, landfilling . in EPA-approved landfills, and storage for incineration or landfilling under this exclusion. _ f. The costs of Riling for an exemption petition, including the costs of making and documenting a "good faith effort to develop substitutes for PCBs" and the cost of determining and documenting that "no unreasonable risk" exists. VI Authority a Section 6(e) of TSCA [15 U.S.C. 2805). The Administrator of EPA has delegated authority to amend or modify the PCB Manufacturing, Processing. Distribution in Commerce and Use Prohibition Rule (4Q CFR Part 761), published in the Federal Register (44 FR 31514. May 31, 1979), to the Assistant Administrator for Pesticides and Toxic Substances. VIL Executive Order 12291 Under Executive Order 12291. issued . February 17,1961, EPA must judge whether a rule is a "major rule" and, therefore, subject to the requirement that a Regulatory Impact Analysis be prepared. EPA has determined that this proposed rule is not a major rule as the term is defined in section 1(b) of the Executive Order. Therefore, EPA has not prepared a Regulatory Impact Analysis for this proposed rule. EPA has concluded that this proposed rule is not "major" under the criteria of section 1(b) because the annual effect of the rule on the economy will be less than 5100 million; it will not cause a ` major increase in costs or prices for any sector of the economy or for any geographic region; and it will apt result in any significant adverse effects on competition, employment investment productivity, or innovation or on the ability of United States enterprises to compete with foreign enterprises in domestic^ foreign markets. In fact this proposed rule excludes certain uses of PCBs that would otherwise be prohibited by section 6(e) of TSCA and, therefore, reduces the overall costs and economic effect of section 6(e). * The proposed rule was submitted to the Office of Management and Budget ' (OMB) prior to publication, as required by the Executive Order. Any comments from OMB to EPA and any response by EPA to those comments are available for public inspection as part of the public record of this rulemaking. Vm Regulatory Flexibility Act Under section 605(b) of the Regulatory Flexibility Act. the Administrator may certify that a rule will not if promulgated, have a significant impact on a substantial number of small entities, and therefore does not require a regulatory flexibility analysis., - The proposed amendment to the PCB rule excludes persons who manufacture PCBs in closed and controlled waste manufacturing processes from the ban 0756062 TOWOLDMONOQ60215 Federal Register / VbL 47. No. 110 / Tuesday. June B. 1982 / Proposed Roles 24987 on manufacture of PCBs. Pot fi)oe persons who qualify lor the exclusion, the effect of this rule Is to avoid the economic impact assodated with the ban. Since no negative economic effect is expected upon any business entity from the promulgation of this proposed rule, I certify that (Us rule will not if promulgated, have a significant . economic impact on small entities. IX. Paperwork Reduction Act The Paperwork Reduction Act ofI960, 44 U.S.C. 3501 et seq (the Act), authorized the Director ofthe OMB to review certain information collection requests by Federal agencies. EPA has determined that die recordkeeping and reporting requirements of this proposed rule constitute a "collection of information," as defined in 44 U.S.C. 3502(4). In accordance with the Act the recordkeeping and reporting requirements of this proposed rule (if ' adopted in the final nile) will be submitted to OMB under section 3504(b) of the Act X. Official Rulemaking Record Proposed PCB Regulations for Closed and Controlled Waste Manufacturing Processes In accordance with the requirements of section 19(a)(3)(E) of TSCA. ETA ia publishing the following list of documents constituting the record of this Sreposed rulemaking. A supplementary at or lists may be published at any time on or before the data the final rule is . issued. However, no such list will include public comments, the transcript of the rulemaking hearing, or ubmissions made at the rulemaking bearing or in connection with it These documents are exempt from Federal Register listing tinder section 19(a)(3). A foil list of these materials will be available on request from the Document Control Officer listed under . "ADMEaspa." -. A. Previous Rulemaking Records 1. Official Rulemaking Record from "Polychlorinated Blpbeayts (PCBs) Manufacturing. Processing. Distribution in Commerce and Use ftotibMons RtdeT 44 FR 91514. May *1.1979. 2. Official Rulemaking Racoed frees "Polychlorinated Biphenyls (PCBe) Disposal and Marking Final Regulation"4J FK TUQ, Fabruary 17. 1S7S. B. Federal Register Notices 1.46 FR 27817. May 2a 1981USEPA . "Polychlorinated Biphenyls (PCBs); ' Manufacture of PCBa In Concentrations Below SO Parts Per MiHiOK Possible Exclusion From Manufacturing Prohibition: Advance notice of proposed rulemaking". 2. 46 PR CTO. May 86.wei.PSgA "Polychlorinated Wpbenyls (PCBs); Court Oder Regarding PCBs in Concentreticnia . Below SO tats to Mdbou." - ' C. Support Documents 1. USEPA. OTS, "Summary ef ANF2 Comments."___ ` 2. USEPA. OTS. "Occupational Expomre to Inadvertency Piudnced PCBs." . 5. USEPA OTS, "Methods ef Analysis for Inddentally Generated PCBs Uteiaturo Review and Preliminary Recomnendabans." 4. USEPA OTS. "Coet Analysis far the Proposal to Exclude Closed and CnntroUad Waste Processes from the PCS Ban." 6. USEPA OTS, "Internal Memorandum of EPA Review of CMA Submitted Toxtdty Data." 6. USEPA OTS, "Quality Aeoumnua Gfideline*." 7. USEPA. OT&, nUtioule far Estimating Level of Quantification for CGC/BdIS." 6. USEPA OTS, "Estimation of Releases from Spills of Inadvertantly Produced PCBa." D. Report* . 1. Otemlcal Manufacturer Association. "A Report of Survey on the ladderstal ' Manufacture. Processing. Distribution, and Use of Polychlorinated Biphenyls at Concentrations Below SO ppm." 2. Chemical Manufacturers Association. "The Analysis et Chlorinated Btpbeoyts." 3. Ecology and Environment Incorporated. ' "Summary,of As Health Effects ofPCBa." ETA will identify the complete - rulemaking record on or before the data of promulgation of the final rule, as prescribed by section 19(3) of TSCA. EPA wifi consider for inclusion in the - record additional material submitted at any time between thepublication of this notice and the date the Agency identifies the final record. The final rule wUl also permit persons to point out any omisalons or errors in the record. XL Additional Information The comment period for this nde is limited to thirty days because EPA is under court order to promulgate a final rule by October 13,1962. EPA requests that comments be submitted in triplicate. Comments ___ should include the docket number, OPTS 62017A. Comments cm this proposed rule 'will be available for review from fcOO an. to 4:00 pm, Monday through ' Friday, excluding holidays, in Rm.E-107 Environmental Protection Agency, 401M St, SW,, Washington. D.C. ' Requests to participate in file Informal hearing should be made in writing to the Industry Assistance Offioe et the ' address given above. AO requests for participation must include, at least, detailed outline of the topics to be addressed in the opening statement the amount of time requested for the statement and the names of the participants. Statements should not repeat information already presented in written comments but should address additional information or issues. All hearings will be conducted in accordance with EPA's "Procedures for Rulemaking Under Section 6 of the Toxic Substances Control Act" (40 CFR. Pert 750). List of Subjects in 40 CFR Part 761 Hazardous materials. Labeling. Polychlorinated biphenyls. Recordkeeping and reporting requirements. Environmental protection. Dated: June 2.1982. Anne M-Gorauch, Administrator. Therefore, it ia proposed that 40 CFR Part 781 be amended to read as follows: PART 761--POLYCHLORINATED BIPHENYLS (PCBs) MANUFACTURING, PROCESSING, DISTRIBUTION IN COMMERCE, AND USE PROHIBITIONS 1. Paragraph (f) is added to { 761.1. to read as follows: ' |71.1 RppTeMBty 44 9 (f) Persons who manufacture, process, distribute in commerce, or use PCBs generated as byproducts, impurities or intermediates in closed and controlled waate manufacturing processes (as defined in f 781J (jj) and | 761.3 (kk)) are exempt from the requirements of Subpart B. To qualify for this exclusion, such processes must also folly comply with | 781.265. 2. Paragraphs (jj) and (Vk) are added to | 761.3, to read as follows: 1781J DeMMona. 44 4 44 .(jj) "Closed manufacturing process" means a chemical manufacturing process in which PCBs are generated but from which no quantifiable PCBs are released to air. water, products, or in process wastes if the analytical method specified in 1791.82 were used. (kk) "Controlled waste manufacturing process" means a chemical manufacturing process in which PCBs are generated but from which no quantifiable PCBs are released to air, water, or products if the analytical methods spedfied.in { 781.82 were used, and the remainder of PCBs generated are incinerated in an incinerator approved under the provisions of f 781.70, landfilled in a landfill approved under the provisions of 1761.75, or stored for such incineration or landfilling in accordance with the requirements of 1781.65(b)(1). 0756063 TOWOLDMONOQ60216 24388 Federal Register / Vol. 47, No. 110 /.Tuesday, June 8, 1982 / Proposed Rules 3. A new Subpart E, consisting at this time of i 781.82, is added to read as follows: SUBPART E-METHOD OF ANALYSIS S7S1A3 Analytical method and quay assurance plan for quantifying PCS* In air, water, products, and doeed procaas waste stream* . (a) Analytical approach. This section is the Agency's designated analytical approach for non-Aroclor PCB analysis This technique Is the method specified under the definitions of closed manufacturing process and controlled waste manufacturing process. Tha . approach includes a description of the analytical technique and a description . of the necessary quality assurance program (QAP). This is the analytical technique and QAP which EPA will use In determining whether a process falls ' within the closed and controlled wasta manufacturing process exclusion (see {7W.t(f)). - (b) Analytical technique. (1) A specified number of samples is taken according to a suggested procedure. Each sample, if too large to go directly to extraction, would be thoroughly homogenized and a representative subsample would be removed. (2) Each sample (or subtample from paragraph (b)(1) of this section) then has surrogate compounds, e.g,, several **C PCB isomers, incorporated into 1L These surrogates are used in quantitation and to document recovery rates. (3) Each sample is then subjected to an extraction and/or cleanup procedure. Through this procedure, the original ample would have any contaminants .and interfering compounds removed from it and ideally an extract with only PCBs would remain. The extraction procedure would vary for different media (air. water, solid) and matrix . (chlorinated, non-chlorinated. etc.). (4) Each sample extract would be concentrated or diluted to a known volume. This known volume is used in the quantitation procedure. (5) A known amount of the prepared extract is then removed and introduced into a capillary gaa chromatograph (CGC) coupled to an electron impact mass spectrometer (EM1S). (6) The instrumental response is then integrated ao that the levels are described by PCB homolog (mono-, dl-, and trichlorobiphenyls, etc.) and each PCB bomolog is quantitated based on . the known responses of the **0 . surrogates (see paragraph (b)(2) of this section). . (7) All 10 homolog concentrations are then summed to obtain a "total PCB" value. (c) Quality assurance program. A quality assurance program includes: (1) An accurate trace or history of tha life of a sample (to be chemically analyzed for PCBs) including a description of the scheme for sample collection including a written description of what happens to the sample, schedules and timetables, . disposition and handling. (2) Details of the sample collection procedure including (1) Reasons for using a particular sample selection process and reasons for not using other processes. (il) Estimates of now Well the selected samples represent the medium to be characterized. (3) A full, detailed description of the extraction and chemical analysis procedures. (4) The results of laboratory participation In round robin analytical programs, the results of performance . audits, the results of systems audits, and analytical results of performance audit specimens. 4. Section 781.185 Is added to read as follows: 1781.184 9eW carUftcation program and retention o4 special records by persons VKNWnliy QOnOTwlQ rvM vl 009VQ maoutec Itsloq processes ird controdad wests manufacturing processes. ' (a) In addition to meeting the basic requirements of 1781.1(f), PCB- genereting chemical manufacturing processes shall be considered "dosed manufacturing processes*" or "controlled waste manufacturing processes" (and thus, be exduded from the TSCA section 8(e) ban on manufacture), only if the owner/ operator of the facility: (1) Collects data on the process and performs either a theoretical analysis of PCB levels in releases or conducts actual sampling of PCB levels In releases. (2) Maintains (for a'period of 7 years or for 3 yean after a process ceases operations, whichever is shorter) the following information on the processes: (1) Theoretical analysis (A) The reaction or reactions believed to be . producing the PCBe and Ievela of PCBa generated. __(B) The basis for all estimations of PCB concentrations. ' (C) The name and qualifications of the person or persona performing the theoretical analysis. . (D) Any additional information relevant to the analysis of the process for PCBs. (il) Actualmonitoring. (A) The method of analysis. . (B) The results of the analysis, Including data from the QAP. (C) The name of the analyst or analysts. (D) The date and time.of the analysis. (E) Any additional information relevant to the analysis of the process for PCBs. . (b) The date collected, and the analysts performed under paragraph (a) of this section must support the following certification if the processes are to be exduded under the closed manufacturing process and controlled waste manufacturing process exdusion. Persons desiring exclusion of a PCB- genera ting process under tbe dosed and controlled waste process exdusion shall certify that (1) An analysis of the manufacturing process for PCB levels and releases (either theoretical or through actual monitoring for PCBs) has been completed. . .. (2) The analysis of tbe manufacturing process is on record at the facility. (3) If the analytical method specified in 1761.82 were used, PCBs could not be quantified In air releases and water releases from the manufacturing process, or in products ol the manufacturing process. (4) (i) If the analytical method specified in | 781.82 were used, PCBs would be below tbe limits of quantification in process wastes. (ii) All process wastes are either incinerated in accordance with { 781.70, landfilled in a landfill approved tinder i 781.75, or stored for such incineration or landfilling in accordance with the requirements of f 781.85(b)(1). (c) The certification must indude the name and location of the disposal facilities (if the process is a controlled waste process^ The certification must be signed by a responsible corporate officer. For the purpose of this section, a responsible corporate officer means: (i) A president, secretary, treasurer, or vice president of the corporation in charge of a principal business function, or any other person who performs siiftilar policy or decision-making functions for the corporation. (ii) The manager of one or more manufacturing, production, or operating facilities employing more than 250 persons or having gross annual sales or expenditures exceeding $25,000,000 (in second quarter 1980 dollars), if authority to sign documents has been assigned or delegated to the manager in accordance with corporate procedures. This certification process must be repeated whenever process conditions are significantly modified to make the previous certification no longer valid. This certification must be filed at each ^facility in which a dosed or controlled 0756064 TOWOLDMONOQ60217 Federal Register / Vol. 47, No. 110 / Taeeday, Jane & 3982 / Proposed Rules waste process is operating for a period of seven yean or for three yean after a process ceases operation, whichever is shorter, and must be made available to EPA upon request (d) Any person signing a document under paragraph (b) (1) through (4) of this section shall also make the . following certification: ' 1 certify under penalty of law that this document and all attachments were prepared under my direction or supervision in accordance with a system designed to assure that qualified personnel properly gather and evaluate informstion. Based on my Inquiry of the person or persons who manage the system, or those person.directly responsible for gathering information, the information is. * to the best of my knowledge and belie! true, eccurate, and complete. I am aware that there are significant penalties tor falsifying . information, including the possibility of fines v and Imprisonment for knowing violations. Dated:* -- . Signature ----------------------------- - -- |ntOae.ss-tsassnMs-r-ankasa| . 24989 0756065 TOWOLDMONOQ60218