[Federal Register: October 19, 1998 (Volume 63, Number 201)] [Proposed Rules] [Page 55812-55831] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr19oc98-16] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 63 [FRL-6176-5] National Emission Standards for Hazardous Air Pollutants for Manufacturing of Nutritional Yeast AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rules; notice of public hearing. ----------------------------------------------------------------------- SUMMARY: The Environmental Protection Agency (EPA) is proposing standards to limit emissions from facilities that manufacture nutritional yeast and are major sources of hazardous air pollutant (HAP) emissions, particularly acetaldehyde. The proposed standards would carry out section 112 of the Clean Air Act, as amended November 15, 1990 (the Act), to protect the public health by [[Page 55813]] reducing these emissions from new and existing facilities. The Act requires these sources to achieve an emissions level consistent with installing and operating maximum achievable control technology (MACT). The proposed standards would eliminate approximately 43 percent of nationwide HAP emissions from these sources. DATES: Comments. Comments must be received on or before December 18, 1998. Public Hearing. Contact us by November 2, 1998 to request to speak at a public hearing. If we receive one or more requests, we will hold the hearing at 10:00 a.m. on November 16, 1998. If you wish to speak or to ask if a hearing will be held, contact the person named under FOR FURTHER INFORMATION CONTACT. ADDRESSES: Public Hearing. If a public hearing is requested it will be held at our Office of Administration's Auditorium in Research Triangle Park, North Carolina. Comments. Send comments (in duplicate if possible) to: Air and Radiation Docket and Information Center (6102), Attention Docket Number A-97-13, Room M-1500, U. S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460. You may also send comments and data by electronic mail (e-mail) to: a-and-r-docket@epamail.epa.gov. (See SUPPLEMENTARY INFORMATION, below, for more on file formats and so on.) Be sure to include the docket number, A-97-13, on your comment. Docket. Docket No. A-97-13 contains information relevant to the proposed rule. You can read and copy it between 8:00 a.m. and 5:30 p.m., Monday through Friday (except for Federal holidays), at our Air and Radiation Docket and Information Center (6102), 401 M Street, S.W., Washington, DC 20460; telephone (202) 260-7548. Go to Room M-1500, Waterside Mall (ground floor). The docket office may charge a reasonable fee for copying. FOR FURTHER INFORMATION CONTACT: Ms. Michele Aston, Policy Planning and Standards Group, Emission Standards Division, (MD-13), U. S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number (919) 541-2363; facsimile number (919) 541- 0942; electronic mail address ``aston.michele@epamail.epa.gov.'' SUPPLEMENTARY INFORMATION: Regulated Entities If your facility manufactures nutritional yeast, which we consider to be varieties of Saccharomyces cerevisiae, it may be a ``regulated entity.'' In addition, the proposed rule would apply to your facility only if the yeast is made for the purpose of becoming an ingredient in dough for bread or any other yeast-raised baked product, or for becoming a nutritional food additive. Regulated categories and entities include sources listed in the main Standard Industrial Classification code for them (2099, Food Preparations Not Elsewhere Classified.) This description is just a guide to entities likely to be regulated by final action on this proposal. It lists the types of entities we think may be regulated, but you should examine the applicability criteria in section II of this preamble and in Sec. 63.2131 of the proposed rule to determine whether your facility is likely to be regulated by final action on this proposal. If you have any questions about whether your facility may need to meet the standards, call the person named under FOR FURTHER INFORMATION CONTACT. Electronic Access and Filing Addresses You can get this notice, the proposed regulatory texts, and other background information in Docket No. A-97-13 by contacting our Air and Radiation Docket and Information Center (see ADDRESSES). Or go to our web site at ``http://www.epa.gov/ttn/oarpg/ramain.html'' for electronic versions of the proposal preamble and regulation, as well as other information. For assistance in downloading files, call the TTN HELP line at (919) 541-5384. If you send comments by electronic mail (e-mail) to ``a-and-r- docket@epamail.epa.gov,'' be sure they're in an ASCII file and don't use special characters or encryption. We will also accept comments and data on diskette in WordPerfect 5.1 or 6.1 or ASCII file format. You may file comments on the proposed rule online at many Federal Depository Libraries. Identify all comments and data in electronic form by the docket number (A-97-13). Don't send any confidential business information through electronic mail. Outline The information presented in this preamble is organized as follows: I. What is the subject and purpose of this rule? II. Does this rule apply to me? III. What procedures did we follow to develop the proposed rule? IV. What are the proposed emission standards? V. How do I show initial compliance with the standard? VI. What monitoring must I do to show ongoing compliance? VII. What if I use an add-on control technology to comply with the standard? VIII. What notification, recordkeeping, and reporting requirements must I follow? IX. What is the basis for selecting the level of the proposed standards? X. What is the basis for selecting the format of the proposed standards? XI. Why did we select the proposed monitoring requirements? XII. Why did we select the proposed test methods? XIII. Why did we select the proposed notification, reporting, and recordkeeping requirements? XIV. How can I comment on this proposed rule? XV. What are the administrative requirements for this proposed rule? XVI. What is the statutory authority for this proposed rule? I. What Is the Subject and Purpose of This Rule? The Act requires EPA to establish standards to control HAP emissions from source categories selected under section 112(c) of the Act. An initial source category list was published in the Federal Register on July 16, 1992 (57 FR 31576). The ``baker's yeast manufacturing'' source category is under the ``Food and Agriculture'' industry group. To clarify the scope of the rule and distinguish it from regulation of bakeries, we changed the name of the source category to ``manufacturing of nutritional yeast.'' Whenever we use ``you'' or ``your'' in this preamble or proposed rule, we mean the owner or operator of a facility that manufactures nutritional yeast. We have identified 10 existing facilities in the source category. The purpose of the proposed rule is to reduce emissions of HAP from major sources that manufacture nutritional yeast. Under the Act, a major source is one with the potential to emit at least 9.1 megagrams per year (Mg/yr) (10 tons per year [tpy]) of any one HAP or 22.7 Mg/yr (25 tpy) of combined HAPs. We estimate at least 9 of these facilities may be major sources and that annual baseline emissions of acetaldehyde from this source category are 254 tpy. The proposed rule would eliminate approximately 43 percent of these emissions. The HAP emitted from the nutritional yeast manufacturing process is acetaldehyde. The primary acute (short-term) effect of inhalation exposure to acetaldehyde is irritation of the eyes, skin, and respiratory tract and, at extremely high concentrations, respiratory paralysis and death. Data from animal studies suggest that acetaldehyde may be a potential developmental toxin, and an increased incidence of nasal tumors in rats and [[Page 55814]] laryngeal tumors in hamsters has been observed following inhalation exposure to acetaldehyde. Human health effects data do not currently exist, but we have classified acetaldehyde as a probable human carcinogen of low carcinogenic hazard. On September 14, 1998, EPA published in the Federal Register a notice of draft integrated urban air toxics strategy to comply with section 112(k), 112(c)(3) and section 202(l) of the Clean Air Act. In that Federal Register document, acetaldehyde is included among the draft list of HAP that we believe pose the greatest threat to public health in urban areas, and manufacturing of nutritional yeast is included on the draft list of source categories for regulation under section 112(k). See 63 FR 49239, September 14, 1998. We recognize that the degree of adverse effects to human health from exposure to acetaldehyde can range from mild to severe. The extent and degree to which the human health effects may be experienced is dependent upon (1) the ambient concentration observed in the area (as influenced by emission rates, meteorological conditions, and terrain), (2) the frequency of and duration of exposures, (3) characteristics of exposed individuals (genetics, age, pre-existing health conditions, and lifestyle), which vary significantly with the population, and (4) pollutant-specific characteristics (toxicity, half-life in the environment, bioaccumulation, and persistence.) Acetaldehyde comprises approximately 18 percent of the total volatile organic compounds (VOC) emitted from nutritional yeast manufacturing. We estimate the current nationwide emissions from nutritional yeast manufacturing facilities to be 1,400 tons per year of VOC. The proposed emission controls for HAP will reduce non-HAP VOC emissions as well. The proposed rule would reduce nationwide VOC emissions by approximately 43 percent, to estimated nationwide emissions of 800 tons per year VOC. Emissions of VOC have been associated with a variety of health and welfare impacts. Volatile organic compound emissions, together with nitrogen oxides, are precursors to the formation of tropospheric ozone, or smog. Exposure to ambient ozone is responsible for a series of public health impacts, such as alterations in lung capacity; eye, nose, and throat irritation; nausea; and aggravation of existing respiratory disease. Ozone exposure can also damage forests and crops. We do not expect any significant other environmental or energy impacts resulting from the proposed rule. Actual compliance costs will depend on each source's existing equipment and the modifications they make to comply with the standard. According to one estimate, up to half of existing facilities may face average capital costs of $385,000 and annual operating costs of $74,000. However, a source's capital costs could exceed $1.5 million if it has to replace a fermentation vessel to comply with the proposed standard. The remaining facilities would not require significant capital expenses, but they would face similar annual operating costs. II. Does This Rule Apply to Me? The proposed rule applies to you if you own or operate any nutritional yeast manufacturing facility that is located at a facility that is a major source of HAP emissions. You would also have to follow the proposed rule if your facility is a non-major (area) source but later increases its potential to emit HAP to major source levels. If your facility is a major source under this regulation, each fermentation production line dedicated to production of Saccharomyces cerevisiae (nutritional yeast, also known as baker's yeast) would be required to meet the proposed emission limits. A ``fermentation production line'' means all fermenters exceeding 7,000 gallons capacity and used in sequence to produce a discrete amount of yeast. We chose 7,000 gallons as the defining capacity cutoff based on industry information indicating that the larger vessels are used exclusively for the fermentation stages we propose to regulate. This regulation limits the definition of ``fermentation production line'' to the collection of fermenters used in the last three fermentation stages, including the final batch. Other terms for fermentations include ``stock, first generation, and trade'' and ``CB4, CB5, and CB6.'' A fermentation production line does not include flask, pure-culture, or yeasting-tank fermentation. A fermentation production line excludes all operations after the last dewatering operation, such as filtration. The proposed regulation applies to you only if the yeast produced at your facility is made for the purpose of becoming an ingredient in dough for bread or any other yeast-raised baked product, or for becoming a nutritional food additive. The proposed rule does not apply to the production of: (1) Specialty yeasts, such as those for wine, champagne, whiskey, and beer. (2) Torula yeast (Candida utilis) using aerobic fermentation. Section IV.B of this preamble discusses why we propose exempting specialty yeasts and Torula yeast. III. What Procedures Did We Follow To Develop the Proposed Rule? A. Source of Authority for Standards Development Section 112(c) of the Act directs us to develop a list of all categories of major sources, plus appropriate area sources, that emit one or more of the 188 HAP listed under section 112(b). Nutritional yeast manufacturing (formerly baker's yeast manufacturing) is a listed source category because of its acetaldehyde emissions. Section 112 further directs us to impose technology-based standards on sources emitting HAP and allows us to revise these technology-based standards later to address risk remaining even with these emission limits. B. Criteria for Developing Standards We develop national emission standards for hazardous air pollutants (NESHAP) to control HAP emissions from new and existing sources according to section 112 of the Act. Section 112(d) of the Act requires the standards to reduce as much HAP emissions as achievable, considering the cost of achieving these reductions, effects on health or environment (other than air), and energy requirements. A NESHAP may be based on measures, which: (1) reduce the volume or eliminate emissions of such pollutants by changing processes, substituting materials, or other modifications, (2) enclose systems or processes to eliminate emissions, (3) collect, capture, or treat such pollutants when released from a process, stack, storage, or fugitive emissions point, (4) are design, equipment, work practice, or operational standards (including requirements for training or certifying operators) as provided in section 112(h), or (5) combine these approaches (section 112(d)(2) of the Act). To develop a NESHAP, we collect information about the industry, including characteristics of emission sources, control technologies, data from HAP emissions tests at well-controlled facilities, and emissions control costs and effects on energy use and the environment. Our information is provided by the sources, their State or local agencies, or it may be collected by us directly. We use this information to analyze possible regulatory approaches. Although NESHAP typically contain numerical limits on emissions, we may need to use other approaches. For example, technological and economic limits may make measuring emissions [[Page 55815]] from a source impossible, or at least impracticable. Section 112(h) of the Act authorizes the Administrator to promulgate a design, equipment, work practice, or operational standard--or a combination of these-- whenever we can't prescribe or enforce an emissions standard. C. Determining the MACT Floor After we identify the specific categories of major sources to regulate under section 112, we must set MACT standards for each of them. Section 112 requires us to use a minimum statutory baseline ( ``floor'') for standards. For new sources, the MACT standards for a source category or subcategory must be at least as stringent as the emission control achieved in practice by the best controlled similar source, as determined by the EPA Administrator (see section 112(d)(3) of the Act). The standards for existing sources can be less stringent than standards for new sources. But, for categories with fewer than 30 sources, the MACT standards must be at least as stringent as the average emission limit achieved by the best performing 5 sources (section 112(d)(3) of the Act). D. Selecting MACT Section 112(d)(2) says we must establish standards that require the maximum degree of reduction in emissions of HAP ``that the Administrator, taking into consideration the cost of achieving such emission reduction, and any non-air quality health and environmental impacts and energy requirements, determines is achievable.'' These standards must be no less stringent than the new and existing source MACT floors. We may distinguish among classes, types, and sizes of sources within a category or subcategory (section 112(d)(1)). For example, we could establish two classes of sources within a category or subcategory based on size, and set a different emissions standard for each class, provided both standards are at least as stringent as the MACT floor for that class of sources. Using the MACT floor as a starting point, we analyze information about the industry to develop model plant populations and project national effects, including HAP emissions reduction levels and compliance costs, as well as secondary energy effects. Then we evaluate various alternatives to select the most appropriate MACT level. The selected alternative may be more stringent than the MACT floor, but if so, it must be technically and economically achievable. We try to reduce emissions as much as possible without unreasonable economic, environmental, or energy impacts (section 112(d)(2)). Regulatory alternatives and decisions may differ for new and existing sources because of different MACT floors and the range of beyond-the-floor control options. Having selected a regulatory alternative, we translate it into a proposed regulation, which typically includes sections on applicability, standards, testing, showing compliance, monitoring, reporting, and recordkeeping. The preamble to the proposed regulation explains our proposed decision. We invite the public to comment on the proposed regulation during the public comment period, evaluate public comments and other information received after proposal, reach a final decision, and then publish the final standard. E. History of the NESHAP for Nutritional Yeast Manufacturing We developed the proposed rule in cooperation with Wisconsin's Department of Natural Resources and Maryland's Department of Environment. When we started gathering information, these two States had recently developed federally enforceable rules for controlling VOC emissions from this source category. The VOC rules were based on reasonably available control technology (RACT), and we believe they represent the most stringent control of VOC (and HAP) in the U.S. for this industry. Our working relationship, called MACT Partnerships, involves States, industry, and environmental organizations and depends on the mutual interests of all major stakeholders in the air toxics program. We asked for public comments on these partnerships by notice in the Federal Register on March 29, 1995 (60 FR 16088). Through MACT partnerships, each MACT standard involves two phases. In the first phase, we develop a ``presumptive MACT,'' which isn't an emission standard. Instead, it states what is known about potential MACT and provides information on how to develop the emission standard. During the second phase, we develop a formal MACT standard for the source category, propose it, and promulgate it. To develop the ``presumptive MACT,'' we first met with State and local agencies, (the presumptive MACT meeting), and then consulted with industry. In the presumptive MACT meeting, we reviewed available information with the States to estimate presumptive MACT. This meeting took place on July 20, 1994 at Research Triangle Park, NC (RTP), and we extended it by conference call with other affected agencies on August 23, 1994. We based the presumptive MACT largely on three sources: (1) information Wisconsin and Maryland State environmental agencies collected as they developed VOC RACT standards, (2) our Control Technology Center's guidance document, ``Assessment of VOC Emissions and their Control from Baker's Yeast Manufacturing Facilities,'' and (3) information we collected from State and local agencies and manufacturers. The summary of the July 20, 1994 meeting, which is available in the project docket, explains how we developed the presumptive MACT. This draft presumptive MACT and summary were then presented at a meeting in RTP on September 22, 1994. The meeting's purpose was to get stakeholders' comments on the selected presumptive MACT. The summary of the September 22, 1994 meeting, which is available in the project docket, outlines the reactions and concerns stakeholders expressed at the meeting. Our presumptive MACT partner, Wisconsin, prepared a technical support document (also available in the project docket) for presumptive MACT. The presumptive MACT presented in 1994 contained the following major elements: (1) suggested MACT floor for existing sources set as an acetaldehyde emission limit of 0.7 pounds per ton of liquid yeast produced (lb/ton LY); (2) suggested MACT floor for new sources set as an acetaldehyde emission limit of 0.2 lb/ton LY; (3) anticipated control of area and major sources; and (4) anticipated control of wastewater emissions resulting from the addition of add-on control technologies at some sources. Following is a summary of the major comments made at the stakeholder meeting: (1) Some companies wanted to monitor their acetaldehyde emissions to verify the assumptions about their ability to comply with the standard and to verify that emissions from dry yeasts are comparable to cream yeast emissions; (2) Stakeholders asked for clarification that the new source standard would apply to complete new production lines, and that the existing source standard would apply to new units added to existing lines; (3) Stakeholders wanted to be kept informed about further development on how MACT would apply to wastewater emissions; (4) Stakeholders wanted exemptions for small area sources based on site-specific risk evaluations; (5) Stakeholders wanted an exemption for small quantity production of specialty yeasts; and (6) Stakeholders wanted flexibility in monitoring requirements [[Page 55816]] and greater certainty over what is required to establish site specific operating parameters. After we developed the presumptive MACT, we consulted with the stakeholders, several of whom provided more data and analysis to help evaluate the standard's effects and ensure our requirements for monitoring, reporting, and recordkeeping are practical. We also did tests at two facilities to validate test methods considered for the MACT standard and to get more emissions data. Beginning in June of 1998, we held additional stakeholder meetings in RTP, NC and by teleconference, to which we invited representatives from the industry, States, and other stakeholders. During these meetings, we reviewed the findings from the presumptive MACT process, summarized our more recent testing results, described our intentions for proposing the MACT standard, and solicited input from the stakeholders. During the course of these meetings and teleconferences, representatives from the States and industry were given the opportunity to provide a great deal of input, and to submit supporting technical information, to assist us in the development of this proposed rulemaking. The rulemaking docket includes minutes from the stakeholder meetings and copies of written information that was provided by the States and industry representatives. Based on our review of the information used to develop the presumptive MACT and the additional information we collected since then, we've determined the MACT floor and selected MACT as described in this preamble. As discussed in the following section, we are co- proposing two MACT standards. IV. What Are the Proposed Emission Standards? With this notice, we are co-proposing two sets of emission limits and associated requirements. One set, which we will refer to within this preamble as the ``RACT standard,'' relies on the concentration- based model used in Wisconsin's and Maryland's RACT rules; this is designated as ``Option 1'' in the proposed regulatory text. The second set, which we will refer to in this preamble as the ``PMACT standard,'' relies on a production-based format, which is the same format considered in the 1994 presumptive MACT described in section III.E of this preamble; this is designated as ``Option 2'' in the proposed regulatory text. Both of the co-proposed regulatory options are printed as proposed standard following this preamble, and both are designated as subpart CCCC, Secs. 63.2130 through 63.2229. In submitting comments, please specify whether the comment pertains to one or both options for the co-proposed standards. We will further evaluate these co-proposed standards based on our review of public comments and other information we may receive. The final rule will reflect either one of the co- proposed standards, a combination of the co-proposed standards, or a different approach altogether. We are accepting public comments on the co-proposed alternatives as well as on any other alternatives. In addition to the standards that are specific to subpart CCCC, the 40 CFR part 63 General Provisions also would apply to you as outlined in Table 3 of the proposed rule. The General Provisions codify procedures and criteria we use to implement all NESHAP promulgated under the amended Act. The General Provisions contain administrative procedures, preconstruction review procedures, and procedures for conducting compliance-related activities such as notifications, recordkeeping and reporting, performance testing, and monitoring. The subpart CCCC proposed rule refers to individual sections of the General Provisions to highlight key sections that we believe will be of particular interest to you. However, unless specifically overridden in Table 3 of the rule, which establishes the applicability of the General Provisions to the subpart, you should assume that all of the applicable General Provisions requirements would apply to you. A. What Are the Emission Limits? RACT Standard. The proposed RACT standard would limit the allowable VOC concentration per fermentation stage during a single fermentation batch from exceeding the following levels: (1) the last fermentation stage (trade) must have emissions of VOC less than or equal to 150 parts per million (ppm), (2) the second-to-last stage (first generation) must have emissions of VOC less than or equal to 225 ppm, and (3) the third-to-last stage (stock) must have emissions of VOC less than or equal to 450 ppm. These limits would apply to new and existing sources and are equal to the existing RACT limits, where VOC is expressed as ethanol. (The State-implemented RACT standards are expressed as propane.) Our proposed RACT standard includes alternate emission limits for each fermentation stage based on an equivalent concentration of acetaldehyde. You can comply with either the emission limit for VOC or the emission limit for acetaldehyde. Prior to your initial compliance demonstration, you would choose one of these two emission limit options. In your initial compliance certification, you would notify the Administrator of your choice, and thereafter you would monitor and report compliance results accordingly. The acetaldehyde monitoring limits are 18 percent of the VOC limits. We chose 18 percent because it is the average percentage of acetaldehyde in total VOC emissions at existing facilities in our MACT floor data base. For the last fermentation stage, the maximum allowable acetaldehyde concentration is 27 ppm. For the second-to-last fermentation stage, the maximum allowable acetaldehyde concentration is 41 ppm. For the third-to-last fermentation stage, the maximum allowable acetaldehyde concentration is 81 ppm. The format of the State-implemented RACT rules is that the emission limits are never to be exceeded. Sources subject to rules of this format must design their control systems to achieve the emissions standard at all times, considering there are fluctuations in manufacturing processes. If the system is always in compliance, over time, the control system results in emission reductions greater than the standard requires. We are taking comment on whether the proposed emission limits should be more stringent, so that they more closely reflect the actual performance of facilities complying with State- implemented RACT standards. Besides establishing concentration-based limits on emissions, the proposed RACT standard would require you to cap the flow rate for every fermenter subject to the standard. This air flow limit is based on the fermenter exhaust's average flow rate for the last 12 months. For fermenters built after October 19, 1998, you must cap the flow rate at the maximum flow rate per fermenter volume that our written guidance specifies. We plan to develop this guidance before publishing the final standard based on our survey of fermenter-to-air flow volumes. See section X.B for discussion on the need for a flow rate cap. PMACT Standard. The proposed PMACT standard would limit VOC emissions from each existing fermentation production line to 9.4 lb/ton LY each calendar month. The proposed PMACT standard would limit VOC emissions from each new fermentation production line to 7.2 lb/ton LY each calendar month. Existing lines are those operating on the date this preamble is published. New fermentation production lines are those [[Page 55817]] you begin constructing or reconstructing after this date. As with the RACT standard, you may choose to monitor acetaldehyde directly and show compliance with an equivalent limit. The acetaldehyde emission limits are 18 percent of the VOC limits. For existing sources, the equivalent acetaldehyde limit is 1.7 lb/ton LY. For new and reconstructed sources, the equivalent limit is 1.3 lb/ton LY. Use of Add-on Control Technology. To comply with the proposed rules, you may decide to limit VOC emissions by using add-on control technologies such as incineration or biofiltration. More likely, you may decide to limit emissions by monitoring process conditions to reduce the formation of VOC while producing yeast. Process-control steps include timing when you add raw materials and optimizing the oxygen supply in the fermenter at critical stages. Interaction with Other Regulations. Whatever the final format, you may have to follow both the NESHAP and other existing rules, such as RACT limits on VOC emissions. If an existing rule and the proposed rule don't conflict, you must comply with both rules. Conflicts would be resolved through your Title V permit, and the most stringent requirements would govern. B. Does the Proposed Rule Have Exemptions? The proposed rule has exemptions for specialty yeasts and Torula yeast produced using aerobic fermentation. Specialty yeasts. This industry mainly produces varieties of nutritional yeast from different strains of Saccharomyces cerevisiae. However, this industry also can produce types of yeast commonly known as ``specialty yeasts.'' Specialty yeasts include those for wine, champagne, whiskey, and beer. Most of these yeasts are varieties of Saccharomyces cerevisiae, but they're genetically diverse, so certain strains do certain things better than others. For example, a whiskey strain may be able to metabolize carbohydrates in an ethanol-rich environment, whereas others can't. But, their uniqueness also means they have narrow uses, so their production is limited compared to that of nutritional yeast. Of all the specialty yeasts, wine yeast is most plentiful, and champagne and whiskey yeasts also make up a large part of the total. Only small amounts of beer yeast are produced. Overall, specialty yeasts usually account for less than 1 percent of a facility's total yeast production. We propose exempting specialty yeast production from the RACT and PMACT standards because it is a small fraction of the total production. It can also be difficult to estimate emissions from this process. Specialty yeasts aren't often produced, so we have no process-control parameters and relevant data to correlate emissions and production. Thus, calculating emissions would be difficult and expensive. Torula yeast. For the following reasons, we've decided not to propose regulating Torula yeast produced using aerobic fermentation. Torula yeast (Candida utilis) is a nutritional yeast, typically produced as an additional product at paper mills. The high sugar concentration of the spent sulfite liquor from the pulping process is an ideal carbon source for Torula yeast. The only possible source of acetaldehyde is the fermentation tank in which the Torula yeast grows. The rest of the processes are either washing, drying, or yeast- conditioning stages. Usually, the paper mill needs only one fermentation tank to produce Torula yeast. The tank typically holds 80,000 gallons, and it is aerated, well agitated, and open to the atmosphere. Because of these well aerated conditions, producing acetaldehyde anaerobically is unlikely. Also, Candida utilis can consume acetaldehyde and ethanol. We conclude that Torula yeast production, as described above, should not be in the national emission standards for nutritional yeast manufacturers because the anaerobic conditions for acetaldehyde production never occur in the fermentation tank. There may be Torula yeast production at nutritional yeast manufacturing facilities. However, we don't have sufficient information on the potential for emitting acetaldehyde or other HAPs to justify exempting all production of Torula yeast. Therefore, we intend our exemption to apply to paper mill-type operations, which use aerobic fermentation. We request comment on whether this exclusion should apply to other sources that produce Torula yeast, if any such operations exist. C. What Pollutants Are Proposed To Be Limited? In both the RACT and the PMACT standards, we propose to limit VOC emissions from fermentation production lines. As discussed in section X.C of this preamble, we believe it is reasonable to use VOC as a surrogate for acetaldehyde, which is the HAP of concern in this source category. However, since some facilities may currently monitor acetaldehyde emissions from their fermenters, the proposed rules also allow you to meet equivalent acetaldehyde emission limits. See sections VI and XI of this preamble for more discussion of monitoring requirements and issues. V. How Do I Show Initial Compliance With the Standard? Under the proposed RACT and PMACT standards, existing sources would have to comply with the final standards within 3 years of publication in the Federal Register. New or reconstructed sources would have to comply upon startup of the affected fermentation production line. RACT Standard. You would show compliance with the RACT emission limit if the average VOC (or equivalent acetaldehyde) concentration for the batch is no more than the concentration in the proposed emission limit for each fermenter and each stage. You must continuously monitor emissions and demonstrate that your monitoring system is operating properly. You must also show that the average flow rate from each fermenter used in a batch is no more than the cap on flow rate established for it. You would monitor flow rate with a calibrated annubar or other approved alternative to determine the air flow in the fermenter's exhaust stack. PMACT Standard. You would show compliance with the PMACT emission limit for each fermentation production line if, for a given calendar month, the average of total batch emissions per ton of liquid yeast produced divided by the number of batch operations is no more than the VOC or equivalent acetaldehyde standard. You must continuously monitor emissions and demonstrate that your monitoring system is operating properly. You must also continuously monitor the exhaust air flow from each fermenter to be able to calculate mass emissions. Finally, you must record the production data needed to determine the tons of liquid yeast produced per batch. Production, or batch yield, means the discrete amount of yeast produced from the last fermentation stage of a batch operation. It is expressed as tons of liquid yeast, based on 30 percent solids. Add-on Control Technology. If you choose to limit emissions by using an add-on control technology, such as incineration or biofiltration, you must also meet the requirements described in section VII of this preamble. VI. What Monitoring Must I Do To Show Ongoing Compliance? You must meet the relevant requirements in 40 CFR 63.8 of the General Provisions, such as those [[Page 55818]] governing how to do monitoring, especially continuous emission monitoring, and how to request alternative monitoring methods. You also must continuously monitor the emissions concentration in every affected fermenter's exhaust stack. If you choose to monitor VOC, you would use Performance Specification 8 (PS 8), in appendix A of 40 CFR part 60, to show your system for continuous monitoring of emissions is operating properly. You would also use EPA Method 25A to do the relative accuracy test PS 8 requires. Or, if you choose to monitor acetaldehyde, you would use PS 9 or an approved alternative to show your monitoring system is operating properly. You'd record all data as 15-minute block values. Both proposed rule formats would require you to continuously monitor the rate of air flow or a parameter of the blower that is correlated with the rate of air flow from each fermenter's exhaust stack. In the case of the RACT rule, this information itself directly measures compliance with the standard's required cap on flow rate. For the PMACT rule, you would combine data on flow rate with concentration data to calculate mass emissions from the stack. You would monitor flow rate with a calibrated annubar or other approved alternative to determine the air flow in the fermenter's exhaust stack. You'd record all data as 15-minute block values. If you choose to limit emissions by using an add-on control technology, such as incineration or biofiltration, you must meet the added monitoring requirements described in section VII of this preamble. VII. What if I Use an Add-On Control Technology To Comply With the Standards? While we do not know of any facilities that intend to use add-on control technologies to meet the proposed emission limits, their use is technologically feasible. Therefore, we are proposing requirements for any facilities which choose this compliance option. Sections 63.2150 through 63.2151 of the proposed rule cover your use of incineration. Sections 63.2155 through 63.2156 of the proposed rule cover biofiltration. In both cases, you would have to test initial performance and show compliance with the limits on VOC emissions. These performance tests would establish monitoring values for the control device's ongoing performance, and you would need to meet this performance parameter. For an incinerator, the temperature in each combustion chamber must stay at or above the minimum temperature established during the performance test, based on 15-minute block values. For a biofiltration system, you must keep the pressure drop across the system within 5 percent and 1 inch of the water column of the complying pressure drop, or within the range of the complying values for pressure drop established during your initial test of performance. VIII. What Notification, Recordkeeping, and Reporting Requirements Must I Follow? Initial Notice. If the standards apply to you, you would need to send a notice to the Administrator within 120 days after the effective date of these standards for existing sources and within 120 days after the date of initial startup for new and reconstructed sources. As outlined in the General Provisions under 40 CFR 63.9, this report notifies the Administrator (or delegated agency under section 112(l) of the Act) that an existing facility must meet the proposed standards or that you've constructed a new facility. Thus it allows you and the Administrator to plan for compliance activities. Notice of Performance Tests and Periods for Evaluating Continuous Emission Monitors. The General Provisions, 40 CFR 63.7 and 40 CFR 63.9(g), require you to notify the Administrator (or delegated agency under section 112(l) of the Act) before testing the performance of control devices and evaluating continuous emissions monitors. Notice of Compliance Status. The General Provisions, 40 CFR 63.9(h), require you to send a notice of compliance status within 60 days after the final compliance date. This report must include your compliance certification, the results of performance tests and monitoring, and a description of how you'll determine continuing compliance as outlined under 40 CFR 63.9. Your notice must include the range of each monitored parameter for each affected source, information verifying this range shows compliance with the emission standard, and information indicating that each source has operated within its designated operating parameters. To comply with the proposed VOC or acetaldehyde emission limits, your compliance report must contain at least three months worth of complying data. Periodic Reports. The following periodic reports are required under this proposal. You would have to send us reports every six months if any of the following were true: Your operation doesn't comply with the emission limits. A monitored value is exceeds its benchmark. A change occurs at your facility or within your process that might affect its compliance status. A change occurs at your facility or within your process that you must normally report in the initial notice. See Sec. 63.2165 of the proposed rules for more information. Other Reports. The General Provisions, particularly sections 40 CFR 63.9 and 63.10, require certain other reports, including those you must do for periods of startup, shutdown, and malfunction. For example, you must develop a startup, shutdown, and malfunction plan. You would have to make the plan available for inspection if the Administrator requests to see it. It would stay in your records for the life of the affected source or until the source no longer must meet the standards in the proposed rule. If your procedures are consistent with your plan, you must say so in writing and deliver or postmark your report to us by July 30 and January 30. If your procedures are inconsistent with your plan, you must report what you're doing within two working days after starting these inconsistent actions, then send us a letter within seven working days after the event ends. IX. What Is the Basis for Selecting the Level of the Proposed Standards? A. What Is the Affected Source? We define an affected source as a stationary source, group of stationary sources, or part of a stationary source regulated by the NESHAP. Within a source category, we select the emission sources (emission points or groupings of emission points) that will make up the affected source. To select these emission sources, we mainly consider the constituent HAP and quantity emitted from individual, or groups, of emission points. In selecting the affected source for the NESHAP on nutritional yeast manufacturing, we identified the HAP-emitting operations at existing facilities. Manufacturers produce yeast in the following steps. Grow the yeast from the pure yeast culture in a series of fermentation vessels. Molasses, nutrients and vitamins are added along with oxygen to ensure optimal feed rates and aerobic conditions for maximizing yield of the final product. Recover the yeast from the final fermenter using centrifugal action to concentrate the yeast solids. Filter the yeast solids using a filter press or a rotary vacuum filter to concentrate the yeast further. [[Page 55819]] Blend the yeast filter cake in mixers with small amounts of water, emulsifiers, and cutting oils. Extrude the mixed press cake and cut it. Wrap the cakes for shipment or dry them to form dry yeast. Acetaldehyde, along with ethanol and other non-HAP VOC, form when conditions in the fermentation tank become anaerobic. The rate of VOC formation is higher in the earlier stages, but results in far less mass than in later stages because the earlier stages occur in smaller fermenters and the overall production rate is lower. One company recently showed that more than 99 percent of emissions from nutritional yeast manufacturing occur during the last three fermentation stages. Therefore, we decided to limit the NESHAP to these last three stages. We also considered whether to treat the affected source as each piece of equipment (fermenter) or as a collection of equipment. Individual facilities differ in the structure of their fermentation lines. Also, even at the same facility, production processes can vary between products and batches. Because of the variability in the number, type, and use of individual fermenters, we're proposing to treat the affected source as the fermentation production line. We've defined the ``fermentation production line'' as the collection of fermenters used in the last three fermentation stages. This collection of fermenters would be required to meet the proposed rules for existing and new sources (i.e., under the proposed RACT approach, each of the fermenters in the last three stages would be required to comply with the applicable VOC/acetaldehyde emission limit, and under the proposed production-based approach, the total mass of VOC/acetaldehyde emissions from the fermenters in the last three stages of each batch must be below the applicable limit per ton LY produced in the batch). Wastewater is another potential source of VOC/acetaldehyde emissions in the nutritional yeast manufacturing process. Wastewater comes from washing and drying the final yeast product. It may also come from using of an add-on control technology that reduces emissions from fermentation. For example, one facility, which is no longer operating, used biofiltration to remove VOC from the stack gas. It also installed a wet scrubber upstream of the biofilter to remove potassium and ammonia from the exhaust gas because these chemicals slow the growth of microorganisms used to remove the VOC. Although scrubbers can remove VOC/acetaldehyde from gas streams, they also produce wastewater that contains VOC and acetaldehyde. Our PMACT partner, Wisconsin, studied the wastewater emissions at two facilities, and determined that acetaldehyde concentration in wastewater was very low (less than 10 ppm). Though the concentration may be low, acetaldehyde emissions from wastewater could total more than 1 ton per year at a large facility. Therefore, we considered acetaldehyde emissions from wastewater as potentially being part of the affected source at facilities manufacturing nutritional yeast. In addition to the operations whose primary purpose is the commercial production of nutritional yeast, large nutritional yeast facilities usually have research and laboratory areas for research and development. These areas may or may not be at the production site. They test new manufacturing protocols or develop new and improved yeast strains. These areas normally have pilot plant sized fermenters to do lab- scale fermentations. The size of the fermenters can be as small as 5 gallons. Although the installations are used regularly, each fermentation batch may have different products and processes because it is experimental research. These types of facilities have no methodical or systematic production process, and the activity varies from day to day. Based on this description of research and development facilities, we believe they should be excluded from the definition of the nutritional yeast manufacturing source category. If we later decide to regulate research and development facilities under a separately defined source category under section 112(c)(7) of the Act, the scope of these later rules might include research and development operations at nutritional yeast manufacturing facilities. B. How Was PMACT Determined? We developed the presumptive MACT (PMACT) for nutritional yeast manufacturing in 1994 with input from Federal, State, and local environmental agencies and industry representatives. The PMACT Technical Support Document, published in September 1994, summarizes emission data and analyzes the MACT floor. In 1994, our findings suggested that PMACT was 0.7 lb of acetaldehyde/ton LY for existing fermentation production lines and 0.21 lb of acetaldehyde/ton LY for new lines. C. What Is the MACT Floor That Is the Basis for the Proposed Standard? After developing the PMACT, we reviewed it, considering deficiencies identified later in certain tests and data analyses as well as test data gathered since that time. As a result, we determined that it may be appropriate to consider the MACT floor from two perspectives. One perspective is that available test data represent the floor--a refined PMACT approach. In considering this approach to setting the floor, we reviewed all available yeast production and emissions data for nutritional yeast manufacturers in the U.S. Because this source category has fewer than 30 sources, we tried to identify the five best-performing sources to establish the MACT floor. We discarded some data because of questionable test methods, particularly in applying Method TO-5. We discarded some data because key variables, such as the fraction of acetaldehyde in the VOC, were not documented. We haven't included one recent test yet because we disagree with the facility on how to measure or estimate flow rates of the emission streams. Finally, we discarded one test because it represented only partial emissions from a facility equipped with an add-on control technology, and it is no longer operating. (See docket number A-97-13 for more information on emission test data and our analysis of the MACT floor.) After deciding which data represented the five best-performing facilities, we revised the draft MACT floor determination for existing fermentation production lines to 1.7 lb acetaldehyde/ton LY. The best performing source can achieve an emissions rate of 1.3 lb acetaldehyde/ ton LY, which represents the MACT floor for new fermentation production lines. This MACT floor is the basis for the emission limits proposed in the PMACT rule. As discussed in section IV.A of this preamble, we've proposed this level of performance both in terms of VOC and as an equivalent acetaldehyde limit. We also considered basing the MACT floor on existing emissions standards, particularly RACT or limits derived from RACT. Of the 10 facilities we confirmed as operating, 5 are subject to RACT or RACT- derived limits. This approach has several advantages compared to the PMACT approach, in both the format of the final standards and the body of data available to support a MACT determination. Therefore, we are proposing that the MACT floor equals RACT. [[Page 55820]] As described in section II of this preamble, we are proposing that a ``fermentation production line'' means all fermenters exceeding 7,000 gallons capacity and used in sequence to produce a discrete amount of yeast. We chose the capacity cutoff of 7,000 gallons to define the fermentation production line, based on industry information that fermentation vessels larger than 7,000 gallons are used exclusively in the last three stages of yeast manufacturing. Essentially, we are using the capacity cutoff of 7,000 gallons to clearly define what we mean by the last three fermentation stages of yeast manufacturing. We are requesting comment on whether there are fermenters smaller than 7,000 gallons capacity that are used in the last three stages of yeast manufacturing. If your comments indicate that smaller fermentation vessels are used in the last three stages of yeast manufacturing, we may promulgate a capacity cutoff value that is smaller than 7,000 so that the capacity cutoff accurately defines the fermentation operations we intend to regulate under this MACT. Wastewater at a nutritional yeast manufacturing facility is a potential source of VOC/HAP emissions. We tried to develop a MACT floor for wastewater emissions. Unconfirmed information gathered during development of the 1994 PMACT document suggests that all facilities send their wastewater to publicly owned treatment works and that there may be one facility that pretreats its wastewater. Because of the extremely limited nature of this information, we haven't been able to set a MACT floor for wastewater at this time. We're requesting comments on MACT floor for wastewater. We will further consider setting a MACT floor for wastewater, based on your comments and data, and any other information that becomes available to us. Upon further consideration, we may set a MACT floor for wastewater based on pretreatment, air emission controls on wastewater units, treatment of wastewater off-site at a POTW, other technologies, or some combination of these options. D. What Is Proposed MACT? As described in our January 1992 document, ``Assessment of VOC Emissions and Their Control from Baker's Yeast Manufacturing'' (EPA- 450/3-91-027), process control on the fermentation production line should be able to reduce 75 to 95 percent of emissions. Vessel design may also reduce emissions, but we can't determine at this point which designs may be most effective for the entire industry. Although using add-on control devices theoretically could reduce emissions 95 to 98 percent, the industry doesn't use them now. One facility that formerly used add-on control technology had enough problems to dissuade us from requiring it, even at new facilities, in the proposed standards. We believe no workable control options exist for the fermentation production line beyond the floor, which is represented by process control at facilities subject to RACT or RACT-like limits. Therefore, we are proposing that MACT equals the MACT floor for the fermentation production line. As discussed in the PMACT approach to the MACT floor, we have identified the top five performing sources in the industry using available data. For this PMACT approach, we selected the average emissions level of these sources as the proposed emission limit for existing sources. We selected the performance of the best-performing source as the proposed emission limit for new sources. The RACT approach is based on at least five existing sources already having to meet RACT or RACT-like limits. We believe these facilities are producing fewer emissions than RACT requires, based on rough analysis of production data and information from these facilities. Thus, although we are proposing the RACT limits as the MACT limits, we will consider comments and data that support a potentially lower MACT emission limit. This information should also allow us to determine if new sources can achieve an even more stringent MACT, based on the best-performing source. For the same reasons we were unable to identify a MACT floor for wastewater emissions, we are not proposing a MACT standard for wastewater emissions at this time. We're requesting comments on regulating wastewater at manufacturers of nutritional yeast, and on appropriate MACT standards for wastewater. We will further consider setting a MACT requirements for wastewater, based on your comments and data, and any other information that becomes available to us. Upon further consideration, we may promulgate MACT requirements for nutritional yeast manufacturing wastewater that include pretreatment, air emission controls on wastewater units, treatment of wastewater off- site at a POTW, other technologies, or some combination of these options. X. What Is the Basis for Selecting the Format of the Proposed Standards? As discussed above, we are co-proposing two standards with different formats. The proposed PMACT standard would be expressed as a limit on the amount of VOC emitted in fermenter offgas for a given amount of yeast produced, in units of weight of VOC per weight of yeast produced. (We standardize yeast production as 30 percent solids.) The proposed RACT standard would be based on the concentration of VOC in fermenter offgas coupled with a limit on air flow from each fermenter. In this section, we will discuss the advantages and disadvantages of each format and request comment on the best format for the promulgated standards. Section 112 of the Act requires us to prescribe emission standards for HAP control unless, in the Administrator's judgment, it is not feasible to prescribe or enforce them according to section 112(h) of the Act: (1) if the HAP can't be emitted through a conveyance designed and built to emit or capture the HAP, or (2) if measurement methodology isn't practicable because of technological or economic limitations. If we can't prescribe or enforce emission standards, we may establish an equipment, work practice, design, or operational standard, or a combination of these approaches. In this case, we know an emission standard is workable for the fermentation production line because several of you are already complying with emission standards on the line, and test methods and monitoring methods are available to measure emissions. We then considered whether the limit should be based on production or on outlet concentration. Both formats have advantages and disadvantages, which we have summarized below. A. Advantages and Disadvantages of a Production-Based Format A production-based format, such as the proposed PMACT regulation, ensures that all regulated sources, even those with variable processes, must meet uniform standards. We do not know of any way that a source could meet a production-based standard by diluting emission streams with increased air flow; however, such dilution is a potential problem under a concentration-based format, such as the proposed RACT-like regulation. A potential problem for the production-based format is that measuring production out of the fermenter is difficult and inexact. Several days' or even weeks' worth of [[Page 55821]] data may be needed to measure production accurately. Also, yields vary significantly, which would make it difficult to correlate the fermenter's yield with the final product delivered. Measuring inputs, such as the amount of sweetener added, is even more complex. A significant concern commenters raised in stakeholder meetings was that a production-based format would require you to submit production information to show compliance, which could damage your competitiveness if the information became available to the public. A related concern is that you would be unable to review the data we used to develop the standard because it must remain confidential. Also, you have raised concerns about the cost and burden of monitoring and recordkeeping, which depend on the sum of emissions from each batch based on the ratio of fermentation stages, plus determining the yield from each batch of trade yeast. One company estimated initial investments of $500,000 to $1,000,000 per facility, and annual expenses of $50,000 to $100,000 per facility. B. Advantages and Disadvantages of a Concentration-Based Format A concentration-based limit, similar to the existing RACT format for VOC, avoids several problems of a production-based limit, such as the need for you to openly report production. This format could allow you and others to more thoroughly review data we use to set the MACT floor. Testing and monitoring costs are likely to be lower, especially if the standard allows you to comply with a VOC standard. Finally, this format allows a shorter averaging time, such as a batch cycle, to measure emissions. One potential disadvantage of a concentration-based format is that sources could meet the standard by increasing air flow, and thus diluting the emission stream, rather than reducing acetaldehyde emissions. Some of you have suggested that this disadvantage should not be a regulatory concern, because the relative expense of air flow handling systems precludes you from installing systems that have excess air flow capacity. Essentially, you have indicated that most fermenter blowers are already operating at their full capacity, and this is not a practical concern for existing sources. However, we continue to consider the potential for dilution of emission streams to be a regulatory concern, particularly for new and modified sources, and are proposing to include a cap on air flow rate. Depending on how we cap the flow rate, some of you expressed concern that you would lose the flexibility to vary the overall balance of flow rate and concentration. Setting a cap also could be difficult given that air flow varies by fermentation stage, product, and other variables. You would also need to show that the cap itself doesn't allow excessive air flow. Some of you also were concerned that reporting flow-rate data would harm confidentiality and competitiveness. C. Why Does the Standard Allow Using VOC as a Surrogate for Acetaldehyde? We propose to regulate VOC emissions as a surrogate for acetaldehyde. Acetaldehyde and ethanol are both undesirable by-products from the fermentation process, and controlling one controls the other. Using a VOC standard will reduce compliance costs, because monitoring VOC is less complex and expensive than monitoring acetaldehyde. We haven't received any evidence that sources can selectively control VOC at the expense of increased acetaldehyde, nor do we know of any incentive for sources to do so. Therefore, we're asking for comment on whether we should promulgate a final standard that allows the use of VOC as a surrogate for acetaldehyde. XI. Why Did We Select the Proposed Monitoring Requirements? The proposed monitoring requirements are consistent with our policy of developing them ``top-down,'' with the most stringent tier representing continuous monitoring that directly measures compliance with the emission limits. We have published appropriate EPA monitoring methods, and several sources already do similar monitoring to show compliance with permit requirements. XII. Why Did We Select the Proposed Test Methods? The proposed rules would require emissions tests for cases in which a source decides to meet the emission limit by using an add-on control device. The test methods we propose to require are existing EPA methods that are familiar to the industry and readily available. Late in proposal development we identified two test methods developed by a voluntary consensus body that may be alternatives for EPA Method 2 and EPA Method 18. The first, ASTM D 3464-96, Standard Test Method for Average Velocity in a Duct Using a Thermal Anemometer, may be an equivalent alternative to EPA Method 2. The second, ASTM D 6060-96, Standard Practice for Sampling of Process Vents with a Portable Gas Chromatograph, is a possible alternative to EPA Method 18, but may lack sufficient quality assurance procedures to fully substitute for Method 18 in this rulemaking. We will further compare these two ASTM methods to EPA Methods 2 and 18, and evaluate the appropriateness of their use for the final subpart CCCC rule. We also request comments on the feasibility of using these or other methods to perform the necessary testing procedures to show compliance with the proposed standards. Because of the long history behind use of the EPA methods, we would need compelling evidence to convince us that other methods are better alternatives. We have identified some concerns related to the use of EPA Method 2 for measuring volumetric flow rate due to unpredictably fluctuating pressures in the exhaust stacks of the fermenters. Under these conditions, it may not be possible to obtain reliable air flow data by using a pitot tube and manometer. We are considering whether we need to modify Method 2 or replace it with another method when we promulgate the final rules. We ask the public to comment and provide relevant information on this issue. XIII. Why Did We Select the Proposed Notification, Reporting, and Recordkeeping Requirements? The proposed rules require you to comply with the notification, recordkeeping, and reporting requirements in the General Provisions. They also establish reporting and recordkeeping requirements we must have to ensure you comply with requirements in subpart CCCC. XIV. How Can I Comment on This Proposed Rule? A. Written Comments We want your participation before arriving at our final decisions and strongly encourage all comments, including complete supporting data and detailed analyses if possible so we can best use these comments. Send all comments to the Air and Radiation Docket and Information Center, Docket No. A-97-13 (see ADDRESSES) by December 18, 1998. If you want to send proprietary information for consideration, clearly distinguish it from other comments and label it ``Confidential Business Information.'' Send submissions containing such proprietary information directly to the following address to make sure the proprietary material doesn't go into the docket: Attention: [[Page 55822]] Michele Aston, c/o Ms. Melva Toomer, U.S. EPA Confidential Business Information Manager, OAQPS (MD-13); Research Triangle Park, North Carolina, 27711. Don't send it to the public docket or through electronic mail. We will disclose information you claim to be confidential only as allowed by 40 CFR part 2. If you don't claim confidentiality, we may make your information available to the public without further notice to you . B. Public Hearing If you want to provide verbal comments about the proposed standards, contact us (see ADDRESSES), and we will hold a public hearing. Anyone may file a written statement by December 18, 1998. Send written statements to the Air and Radiation Docket and Information Center (see ADDRESSES), and refer to Docket No. A-97-13. If a public hearing is held, we will place a verbatim transcript of the hearing and written statements in the docket, which you can read and copy at the Air and Radiation Docket and Information Center (see ADDRESSES). XV. What Are the Administrative Requirements for This Proposed Rule? A. Docket The docket for this regulatory action is A-97-13. The docket is an organized and complete file of all the information we considered in developing this proposed rule. It's a dynamic file because we keep adding material throughout the rule's development. The docketing system allows you to readily identify and locate documents so you can participate in rulemaking. Along with the proposed and promulgated standards and their preambles, contents of the docket will serve as the record in case of judicial review (see section 307(d)(7)(A) of the Act). B. Executive Order 12866 Under Executive Order 12866 (58 FR 51735, October 4, 1993), we must determine whether the regulatory action is ``significant'' and therefore subject to review by the Office of Management and Budget (OMB). The Executive Order defines ``significant regulatory action'' as one that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency. (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof. (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. Because the proposed rules will affect only 10 existing facilities, and because we expect no new facilities, we project the economic effects to be far less than $100 million nationwide. Nor do we anticipate any significant adverse effects to the facilities. Under Executive Order 12866, this action is not a significant regulatory action and is therefore not subject to OMB review. C. Enhancing the Intergovernmental Partnership Under Executive Order 12875 Under Executive Order 12875, EPA may not issue a regulation that is not required by statute and that creates a mandate upon a State, local or tribal government, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by those governments, or EPA consults with those governments. If EPA complies by consulting, Executive Order 12875 requires EPA to provide to the Office of Management and Budget a description of the extent of EPA's prior consultation with representatives of affected State, local and tribal governments, the nature of their concerns, copies of any written communications from the governments, and a statement supporting the need to issue the regulation. In addition, Executive Order 12875 requires EPA to develop an effective process permitting elected officials and other representatives of State, local and tribal governments ``to provide meaningful and timely input in the development of regulatory proposals containing significant unfunded mandates.'' Today's rule does not create a mandate on State, local or tribal governments. The rule does not impose any enforceable duties on State, local or tribal governments, because they do not own or operate any sources subject to this rule and therefore are not required to purchase control systems to meet the requirements of this rule. Accordingly, the requirements of section 1(a) of Executive Order 12875 do not apply to this rule. Nevertheless, in developing this rule, EPA consulted with States, as described in section III.E of this preamble, to enable them to provide meaningful and timely input in the development of this rule. D. Consultation and Coordination With Indian Tribal Governments Under Executive Order 13084 Under Executive Order 13084, we may not issue a regulation that is not required by statute, that significantly or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments. If the mandate is unfunded, we must provide OMB, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires us to develop an effective process permitting elected and other representatives of Indian tribal governments ``to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.'' Today's rule does not significantly or uniquely affect the communities of Indian tribal governments because no known nutritional yeast manufacturing facilities are located within these governments' jurisdiction. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule. E. Paperwork Reduction Act We've submitted to OMB requirements for collecting information associated with the proposed standards (those included in 40 CFR part 63, subpart A and subpart CCCC) for approval under the Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq. We have prepared an Information Collection Request (ICR) document (ICR No. 1886-01), and you may get a copy from Sandy Farmer, OP, Regulatory Information Division, U. S. Environmental Protection Agency (2137), 401 M Street, S.W., Washington, DC 20460, or by calling (202) 260-2740. A copy may also be downloaded off the interent at http://www.epa.gov/icr. The total 3-year burden of monitoring, recordkeeping, and reporting for this collection is estimated at 19,135 labor hours, and the annual average burden is 6,379 labor hours for the affected facilities. Annual capital costs for VOC monitoring systems is estimated to be [[Page 55823]] $622,300 ($373,400 per facility for five facilities and annualized over three years). This estimate includes annual performance tests for some sources; ongoing monitoring for all sources; semiannual reports when someone doesn't follow a plan for startups, shutdowns, and malfunctions; quarterly and semiannual reports on excess emissions; maintenance inspections; notices; and recordkeeping. Burden means the total time, effort, or financial resources people spend to generate, maintain, keep, or disclose to or for a Federal Agency. This includes the time needed to review instructions; develop, acquire, install, and use technology and systems to collect, validate, and verify information; process, maintain, disclose, and provide information; adjust ways to comply with any previously applicable instructions and requirements; train people to respond to a collection of information; search data sources; collect and review information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person need not respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are in 40 CFR part 9 and 48 CFR Chapter 15. Send comments on the Agency's need for this information, the accuracy of our burden estimates, and any suggested methods for lessening a respondent's burden (including automation) to the Director, OP Regulatory Information Division, U. S. Environmental Protection Agency (2137), 401 M Street SW, Washington, DC 20460, and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503. Mark your comments ``Attention: Desk Office for EPA.'' Include EPA's ICR number in any correspondence. The final rule will respond to all comments from OMB or the public on this proposal's information-collection requirements. F. Regulatory Flexibility Act The Regulatory Flexibility Act ( RFA) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small governmental jurisdictions. This proposed rule would not have a significant impact on a substantial number of small entities because few or none of the 10 facilities expected to be subject to the proposed rule are small entities, and because the regulatory impacts are anticipated to be insignificant. Therefore, I certify that this proposed action will not have a significant economic impact on a substantial number of small entities. G. Unfunded Mandates Reform Act Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub. L. 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, we generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with ``Federal mandates'' that may result in expenditures to State, local and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows us to adopt an alternative other than the least costly, most cost-effective or least burdensome alternative if the Administrator publishes with the final rule an explanation why the alternative was not adopted. Before we establish any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, we must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements. We have determined that this proposed rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any one year. The proposed rule does not impose any enforceable duties on State, local, or tribal governments, i.e., they own or operate no sources subject to this proposed rule and therefore are not required to purchase control systems to meet the requirements of this proposed rule. Regarding the private sector, the proposed rule will affect only 10 existing facilities nationwide. We project that annual economic effects will be far less than $100 million. Thus, today's proposed rule is not subject to the requirements of sections 202 and 205 of the UMRA. Nevertheless, in developing this proposed rule, EPA consulted with States, as described in section III.E of this preamble, to enable them to provide meaningful and timely input in the development of this proposed rule. We also have determined that this proposed rule contains no regulatory requirements that might significantly or uniquely affect small governments. The proposed rule does not impose any enforceable duties on small governments, i.e., they own or operate no sources subject to this rule and therefore are not required to purchase control systems to meet the requirements of this proposed rule. H. Protection of Children From Environmental Health Risks and Safety Risks Under Executive Order 13045 Executive Order 13045 applies to any rule that EPA determines: (1) ``economically significant'' as defined under Executive Order 12866, and (2) the environmental health or safety risk addressed by the rule has a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children and explain why the planned regulation is preferable to other potentially effective and reasonable alternatives considered by the Agency. The proposed rule is not subject to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because it is not an economically significant regulatory action as defined by Executive Order 12866. I. National Technology Transfer and Advancement Act Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (``NTTAA''), Pub. L. No. 104-113, section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus [[Page 55824]] standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This proposed rulemaking involves technical standards. We propose to use longstanding EPA Reference test methods and procedures that show compliance with emission standards. Specifically, we require EPA test methods 1 through 4 and 25A, and Performance Specifications 8 and 9, as codified at 40 CFR part 60, appendix A. We identified two candidate voluntary consensus standards as being potentially applicable, and we are soliciting comment on them in this proposed rulemaking. These methods are discussed in more detail in section XII of this preamble. XVI. What is the Statutory Authority for This Proposed Rule? The statutory authority for this proposal is provided in sections 101, 112, 114, 116, and 301 of the Clean Air Act as amended (42 U.S.C. 7401, 7412, 7414, 7416, and 7601). This rulemaking is also subject to section 307(d) of the Act (42 U.S.C. 7407(d)). List of Subjects in 40 CFR Part 63 Environmental protection, Air pollution control, Hazardous substances, Nutritional yeast manufacturing, Reporting and recordkeeping requirements. Dated: October 7, 1998. Carol M. Browner, Administrator. For the reasons set out in the preamble, the U.S. Environmental Protection Agency proposes to amend 40 CFR part 63 as follows: PART 63--NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES 1. The authority citation for part 63 continues to read as follows: Authority: 42 U.S.C. 7401, et seq. 2. Part 63 is amended by adding subpart CCCC (Option 1 and Option 2) to read as follows: [Option 1 for Subpart CCCC] Subpart CCCC--National Emission Standards for Hazardous Air Pollutants for Manufacturing of Nutritional Yeast What This Regulation Covers Sec. 63.2130 What is in this regulation? 63.2131 Does this regulation apply to me? Emission Standards and Compliance Dates 63.2135 What emission standards must I meet? 63.2136 When must I comply? General Requirements for Compliance With the Emission Standards and for Monitoring and Performance Tests 63.2140 What general requirements must I meet to comply with the standard? 63.2141 What monitoring must I do? 63.2142 What performance tests must I complete? Requirements for Showing Compliance Using Process Control 63.2145 If I use process control, how do I comply with the standard? Requirements for Incinerators 63.2150 If I use an incinerator, what monitoring must I do? 63.2151 If I use an incinerator, how do I comply with the standard? Requirements for Biofiltration 63.2155 If I use biofiltration, what monitoring must I do? 63.2156 If I use biofiltration, how do I comply with the standard? Requirements for Other Means of Monitoring 63.2160 How can I get approval for, and use, other means of monitoring? Reporting and Recordkeeping Requirements 63.2165 What reports must I prepare? 63.2166 What records must I maintain? 63.2167 How long do I have to maintain records? Delegation of Authorities 63.2170 What authorities may be delegated to the States? Secs. 63.2171-63.2229 [Reserved] Subpart CCCC--National Emission Standards for Hazardous Air Pollutants for Manufacturing of Nutritional Yeast What This Regulation Covers Sec. 63.2130 What is in this regulation? This regulation describes the actions you must take to reduce emissions if you own or operate a facility that manufactures nutritional yeast, also known as baker's yeast or Saccharomyces cerevisiae. The regulation establishes emission standards and states what you must do to comply. Certain requirements apply to all who must follow the regulation; others depend on the means you use to comply with an emission standard. Sec. 63.2131 Does this regulation apply to me? (a) This regulation applies to you if you own, operate, or build a facility that manufactures nutritional yeast and it falls under either of the following categories: (1) It is located at a new or existing major source of hazardous air pollutant (HAP) emissions, meaning: ``any stationary source or group of stationary sources located within a contiguous area and under common control that emits or has the potential to emit considering controls, in the aggregate, 10 tons per year or more of any hazardous air pollutant or 25 tons per year or more of any combination of hazardous air pollutants.'' (2) It is located at a new or existing area source that increases its actual or potential HAP emissions enough to become a major source. (b) Each individual fermentation production line is an affected source if it supports the industrial production of Saccharomyces cerevisiae and it fits the following descriptions. (1) Fermentation production line. A ``fermentation production line'' means all fermenters that can hold more than 7,000 gallons and are used in sequence to produce yeast. This regulation limits the line to the last three fermentation stages, which may be referred to as ``stock, first generation, and trade'' and ``CB4, CB5, and CB6.'' A batch combines these three fermentation stages to produce a single product. A fermentation production line excludes flask, pure-culture, or yeasting-tank fermentation, as well as all operations after the last dewatering operation, such as filtration. (2) Purposes of yeast production. This regulation applies to your facility only if the yeast is made for the purpose of becoming an ingredient in dough for bread or any other yeast-raised baked product, or for becoming a nutritional food additive. (c) This regulation also doesn't apply when you perform any of the following operations at your facility: (1) Produce specialty yeasts, such as those for wine, champagne, whiskey, and beer. (2) Produce torula yeast (Candida utilis) using aerobic fermentation. Emission Standards and Compliance Dates Sec. 63.2135 What emission standards must I meet? (a) Unless you comply with the standard using equipment specified in paragraphs (c) or (d) of this section, you must meet the emission limits for volatile organic compounds (VOC) or acetaldehyde in the exhaust-gas stream from a fermenter during a fermentation batch. (1) Prior to submitting your compliance certification under Sec. 63.9(h) (initial compliance), you must select [[Page 55825]] whether you will monitor VOC or acetaldehyde. This selection will determine the applicable standards for your facility. Section 63.2165 contains additional information on the notification procedures you must follow in making your selection. (2) If you monitor VOC, comply with the concentration limits of Table 1 of this section: Table 1.--Limits on VOC Concentrations ------------------------------------------------------------------------ Maximum allowable concentration Fermentation stage of VOC, measured as ethanol (ppm) ------------------------------------------------------------------------ Last stage (Trade)....................................... 150 Second-to-last stage (First generation).................. 225 Third-to-last stage (Stock).............................. 450 ------------------------------------------------------------------------ (3) If you monitor acetaldehyde, comply with the concentration limits of Table 2 of this section: Table 2.--Limits on Acetaldehyde Concentrations ------------------------------------------------------------------------ Maximum allowable concentration Fermentation stage of acetaldehyde (ppm) ------------------------------------------------------------------------ Last stage (Trade)....................................... 27 Second-to-last stage (First generation).................. 41 Third-to-last stage (Stock).............................. 81 ------------------------------------------------------------------------ (b) If you follow the procedures in paragraph (a) of this section, you must maintain the exhaust flow rate over a batch for every fermenter below the maximum flow rate set according to the following procedures. (1) For an existing fermenter, set the flow rate cap based on the average exhaust flow rate for that fermenter over the last 12 months. (2) For a fermenter constructed or reconstructed after October 19, 1998, you must cap the flow rate at the maximum flow rate per fermenter volume specified in our written guidance. (c) If you use an incinerator to comply with the standard, you must maintain the minimum operating temperature established in Sec. 63.2142(a). (d) If you use a biofilter to comply with the standard, you must maintain the pressure drop within the complying pressure drop range established in Sec. 63.2142(a). Sec. 63.2136 When must I comply? (a) If construction of your fermentation production line commenced on or before October 19, 1998, you must comply on and after [Insert date 3 years from publication of final rule in Federal Register.] (b) If construction or reconstruction of your fermentation production line commenced after October 19, 1998, you must comply on and after [Insert date of publication of final rule in Federal Register] or on and after the date when you start operations, whichever is later. (c) If your fermentation production line becomes an affected source after October 19, 1998, you must comply on and after the date 3 years following the day it became an affected source, as defined by Sec. 63.2131. (d) If you can't meet a deadline, you may ask to extend the compliance date by following the criteria and procedures in Sec. 63.6(i). (e) You must comply with the provisions in this subpart at all times except during periods of start-up, shutdown, and malfunction (as defined in Sec. 63.2.) General Requirements for Compliance With the Emission Standards and for Monitoring and Performance Tests Sec. 63.2140 What general requirements must I meet to comply with the standard? (a) Process control. You may use process control to reduce VOC and acetaldehyde emissions and comply with the emission standard. ``Process control'' means reducing emissions of VOC and acetaldehyde by manipulating the flow of raw material, supply of oxygen, or some other input, thereby controlling fermentation. (b) Add-on control technology. As an alternative to process control, you may use an add-on control technology, such as incineration or biofiltration, to reduce VOC and acetaldehyde emissions and comply with the emission standard. (c) Showing compliance. Whether you use process or add-on controls, you must show initial and ongoing compliance with the emission standards in Sec. 63.2135. See the rest of this subpart for procedures you must follow. (d) Operation and maintenance. You must comply with the operation and maintenance requirements in Sec. 63.6(e). (e) General Provisions. The General Provisions (40 CFR part 63, subpart A) apply to owners and operators of major sources of HAP emissions in all source categories, including nutritional yeast manufacturing. Table 1 of this section lists the General Provisions that apply to nutritional yeast manufacturing facilities: Table 1 of Sec. 63.2140--General Provisions That Apply to Subpart CCCC ------------------------------------------------------------------------ Applies to subpart Reference, subpart A general CCCC, 63.2130- Comment provisions 63.2229 ------------------------------------------------------------------------ 63.1-63.5...................... Yes. 63.6(a)-(g), (i)-(j)........... Yes. 63.6(h)(1)-(h)(6), (h)(8)- Yes. (h)(9). 63.7(h)(7)..................... No................. Sec. 63.6(h)(7), using continuous opacity monitoring, doesn't apply. 63.7........................... Yes. 63.8........................... Yes. 63.9........................... Yes. 63.10.......................... Yes. 63.11.......................... No................. Don't use flares to comply with the emission limits. 63.12-63.15.................... Yes. ------------------------------------------------------------------------ [[Page 55826]] Sec. 63.2141 What monitoring must I do? (a) You must meet the requirements of Sec. 63.8. (b) You must install, calibrate, operate, and maintain all monitoring equipment according to manufacturer's specifications and the plan for startup, shutdown, and malfunctions that you must develop and use according to Sec. 63.6(e). (c) If you choose to continuously monitor VOC emissions, you must use Performance Specification 8 (PS 8), in appendix A of 40 CFR part 60, to show that your continuous emission monitoring system (CEMS) is operating properly. (1) Use EPA Method 25A, in appendix A of 40 CFR part 60, to do the relative-accuracy test PS 8 requires. (2) Calibrate the reference method and the CEMS with ethanol. (3) Collect a 1-hour sample for each reference-method test. (4) Set the CEMS span at 1.5 to 2.5 times the relevant emission limit. (d) If you choose to continuously monitor acetaldehyde emissions, you must use PS 9 or an approved alternative to show that your CEMS is operating properly. (e) If you are subject to Sec. 63.2135(b), you must continuously monitor either the air-flow rate or a parameter of the blower system correlated with the air-flow rate exiting each fermenter's exhaust stack. Use a calibrated annubar or other approved alternative to determine the air flow in the fermenter's exhaust stack. A ``fermenter's exhaust stack'' means the vent or ductwork that provides an outlet for gas from a fermenter. Sec. 63.2142 What performance tests must I complete? (a) Testing frequency. If you choose to comply with the standard using an add-on control technology, you must test its initial performance to show compliance with the emission limits in Sec. 63.2135(a)(2) or (a)(3) and to establish baseline monitoring parameters that satisfy Secs. 63.2150 and 63.2155, as applicable. You must test the control device's performance while manufacturing the product that comprises the largest percentage of average annual production. Test the device's performance within 180 days from the compliance date that applies to you and test it again at least every 3 years or when process conditions change that would require a new correlation. (b) Approved test methods. You must follow the procedures in Secs. 63.7 and 63.8 and use one of the following test methods. Unless changed in this subpart, all EPA methods are in appendix A of part 60 of this chapter. (1) Use Method 1 to select the sampling port's location and the number of traverse points. (2) Use Method 2 to measure volumetric flow rate. (3) Use Method 3 for gas analysis to determine the dry molecular weight of the stack gas. (4) Use Method 4 to determine moisture content of the stack gas. 40 CFR part 60. (5) Use EPA Method 25A, or any alternative validated by EPA Method 301, to measure VOC as ethanol. (c) Additional requirements for performance tests. Make sure you: (1) Design the test to sample a complete batch. You must do three sampling runs for each of the three fermentation stages in a batch, as defined in this rule. (2) Do the test at a point in the exhaust-gas stream before you inject any dilution air, meaning any air not needed to control fermentation. (3) Record the results of each run of the performance test. Requirements for Showing Compliance Using Process Control Sec. 63.2145 If I use process control, how do I comply with the standard? (a) If you monitor VOC using data obtained under Sec. 63.2141(c), you must calculate the VOC concentration (measured as ethanol) from each fermentation stage of the batch. Record data as 15-minute block values. To be valid, your monitoring must meet the following requirements: (1) Two 15-minute block values per hour. (2) Eighteen or more hours per day. (3) Eighteen or more days for each 30-day period. (b) The VOC concentration of a stage is the average of all 15- minute block values recorded during that stage. You meet the emission standard in Sec. 63.2135(a) if the VOC concentration is no more than the values in Table 1 for each fermenter. (c) If you monitor acetaldehyde using data obtained under Sec. 63.2141(d), you must calculate the acetaldehyde concentration from each fermentation stage of the batch. Record data as 15-minute block values. To be valid, your monitoring must meet the following requirements: (1) Two 15-minute block values per hour. (2) Eighteen or more hours per day. (3) Eighteen or more days for each 30-day period. (d) The acetaldehyde concentration of a stage is the average of all 15-minute block values recorded during that stage. You meet the emission standard in Sec. 63.2135(a) if the acetaldehyde concentration is no more than the values in Table 2 for each fermenter. (e) Using the data obtained under Sec. 63.2141(e), you must calculate the flow rate from each fermenter for each batch. Record data as 15-minute block values. To be valid, your monitoring must meet the following requirements: (1) Two 15-minute block values per hour. (2) Eighteen or more hours per day. (3) Eighteen or more days for each 30-day period. (f) The flow rate of a stage is the average of all 15-minute block values recorded during that stage. You meet Sec. 63.2135(b) if the flow rate recorded for each fermenter is no more than the maximum flow rate cap established under Sec. 63.2135(b). Requirements for Incinerators Sec. 63.2150 If I use an incinerator, what monitoring must I do? (a) You must monitor and record the temperature in the main chamber and afterburner at least once every 15 minutes. (b) Make sure the monitoring equipment is installed and operating, and verify the data, before or during the performance test. To verify that your equipment is operating, you must meet at least one of the following standards: (1) The manufacturer's written specifications or recommendations for installing, operating, and calibrating the system. (2) Other written procedures that ensure reasonably accurate monitoring. (c) Install, operate, and maintain the monitoring equipment so it gives you representative measurements of parameters from the regulated sources. Sec. 63.2151 If I use an incinerator, how do I comply with the standard? (a) First, you must establish the minimum operating temperature for each combustion chamber and afterburner with a performance test under procedures in Sec. 63.2142. The minimum operating temperature is the average of the three test run values recorded under Sec. 63.2142(c). (b) Second, you must ensure that the temperature in each combustion chamber stays at or above the minimum operating temperature, based on 15-minute block values taken according to Sec. 63.2150. [[Page 55827]] Requirements for Biofiltration Sec. 63.2155 If I use biofiltration, what monitoring must I do? (a) You must monitor and record the pressure drop across the biofiltration system at least once every 8 hours. (b) You must maintain the pressure drop across the biofiltration system within 5 percent and 1 inch of the water column of the complying pressure drop, or within the range of the complying values for pressure drop established during your initial performance test. ``Complying pressure drop'' means the pressure drop at which your system meets an emission standard. Sec. 63.2156 If I use biofiltration, how do I comply with the standard? (a) You must establish the complying pressure drop across the system during a performance test, following procedures in Sec. 63.2142. (b) For each biofiltration system, you may establish either of the following: (1) A range of complying pressure drops by conducting multiple compliance performance tests. (2) One complying pressure drop as the average pressure drop measured over three test runs of a single performance test. (c) The pressure drop across your system must stay within 5 percent and 1 inch of the water column of the complying pressure drop, or range established in your performance test. Requirements for Other Means of Monitoring Sec. 63.2160 How can I get approval for, and use, other means of monitoring? (a) Monitoring and recordkeeping. (1) Request and receive approval from the Administrator to use other monitoring methods, following Sec. 63.8(f). (2) Use the approved alternate monitoring procedure so you continuously meet the emission standard that applies to you. (3) Comply with monitoring and recordkeeping requirements the Administrator specifies. (b) Compliance demonstrations. (1) Do an initial performance test to show you meet the emission standard. (2) During any performance test, you must show that your monitoring method can determine whether your process controls or add-on controls meet the emission standard that applies to you. (3) Unless the Administrator specifies another schedule, test performance once per year. Reporting and Recordkeeping Requirements Sec. 63.2165 Which reports must I prepare? (a) You must follow the notification procedures in Sec. 63.9 and the reporting requirements in Sec. 63.10. If the Administrator hasn't delegated authority under subpart E of this part to your State, you must notify the EPA's appropriate regional office. If your State has delegated authority, notify your State and send copy of each notice to the appropriate EPA regional office. The regional office may waive this requirement. (b) Following the procedures in Sec. 63.9(h), within 60 days after completing the relevant compliance demonstration activity specified in Secs. 63.2145, 63.2151, or 63.2156, notify the Administrator of your initial compliance status. In the case of Sec. 63.2145, process control, you must report at least three months worth of complying data. (c) Annually, certify your compliance by reporting the following information: (1) How you determined compliance, including specific information about the parameters you monitored and the methods you used to monitor them. (2) The results of your monitoring procedures or methods. (3) How you will continue to comply including a description of monitoring and reporting requirements and test methods. (4) A statement attesting to whether your facility has complied with this regulation, signed by a responsible official who shall certify its accuracy. Sec. 63.2166 What records must I maintain? (a) In addition to meeting the recordkeeping requirements under Sec. 63.10, you must record the following information in a daily log: (1) Operation time for all control devices and monitoring equipment. (2) Details of all routine and other maintenance on all control devices and monitoring equipment, including dates and duration of any outages. (3) The fermentation stage for which you're using each fermenter. (b) You must also record the information required to support your compliance demonstrations under Secs. 63.2145, 63.2151, and 63.2156. Sec. 63.2167 How long do I have to maintain records? You must keep all records available for inspection for at least 5 years--onsite for the most recent 2 years of operation. You may keep records for the previous 3 years off site. Delegation of Authorities Sec. 63.2170 What authorities may be delegated to the States? (a) In delegating implementation and enforcement authority to a State under subpart E of this part, the Administrator will retain the authorities contained in paragraph (b) of this section. (b) [Reserved] Sec. 63.2171--63.2229 [Reserved] [Option 2 for Subpart CCCC] Subpart CCCC--National Emission Standard for Hazardous Air Pollutants for Manufacturing of Nutritional Yeast What This Regulation Covers Sec. 63.2130 What is in this regulation? 63.2131 Does this regulation apply to me? Emission Standards and Compliance Dates 63.2135 What emission standards must I meet? 63.2136 When must I comply? General Requirements for Compliance With the Emission standards and for Monitoring and Performance Tests 63.2140 What general requirements must I meet to comply with the standard? 63.2141 What monitoring must I do? 63.2142 What performance tests must I complete? Requirements for Showing Compliance Using Process Control 63.2145 If I use process control, how do I comply with the standard? Requirements for Incinerators 63.2150 If I use an incinerator, what monitoring must I do? 63.2151 If I use an incinerator, how do I comply with the standard? Requirements for Biofiltration 63.2155 If I use biofiltration, what monitoring must I do? 63.2156 If I use biofiltration, how do I comply with the standard? Requirements for Other Means of Monitoring 63.2160 How can I get approval for, and use, other means of monitoring? Reporting and Recordkeeping Requirements 63.2165 What reports must I prepare? 63.2166 What records must I maintain? 63.2167 How long do I have to maintain records? Delegation of Authorities 63.2170 What authorities may be delegated to the States? 63.2171-63.2229 [Reserved] [[Page 55828]] Subpart CCCC--National Emission Standards for Hazardous Air Pollutants for Manufacturing of Nutritional Yeast What This Regulation Covers Sec. 63.2130 What is in this regulation? This regulation describes the actions you must take to reduce emissions if you own or operate a facility that manufactures nutritional yeast, also known as baker's yeast or Saccharomyces cerevisiae. The regulation establishes emission standards and states what you must do to comply. Certain requirements apply to all who must follow the regulation; others depend on the means you use to comply with an emission standard. Sec. 63.2131 Does this regulation apply to me? (a) This regulation applies to you if you own, operate, or build a facility that manufactures nutritional yeast and it falls under either of the following categories: (1) It is located at a new or existing major source of hazardous air pollutant (HAP) emissions, meaning: ``any stationary source or group of stationary sources located within a contiguous area and under common control that emits or has the potential to emit considering controls, in the aggregate, 10 tons per year or more of any hazardous air pollutant or 25 tons per year or more of any combination of hazardous air pollutants.'' (2) It is located at a new or existing area source that increases its actual or potential HAP emissions enough to become a major source. (b) Each individual fermentation production line is an affected source if it supports the industrial production of Saccharomyces cerevisiae and it fits the following descriptions. (1) Fermentation production line. A ``fermentation production line'' means all fermenters that can hold more than 7,000 gallons and are used in sequence to produce yeast. This regulation limits the line to the last three fermentation stages, which may be referred to as ``stock, first generation, and trade'' and ``CB4, CB5, and CB6.'' A batch combines these three fermentation stages to produce a single product. A fermentation production line excludes flask, pure-culture, or yeasting-tank fermentation, as well as all operations after the last dewatering operation, such as filtration. (2) Purposes of yeast production. This regulation applies to your facility only if the yeast is made for the purpose of becoming an ingredient in dough for bread or any other yeast-raised baked product, or for becoming a nutritional food additive. (c) This regulation also doesn't apply when you perform any of the following operations at your facility: (1) Produce specialty yeasts, such as those for wine, champagne, whiskey, and beer. (2) Produce torula yeast (Candida utilis) using aerobic fermentation. Emission Standards and Compliance Dates Sec. 63.2135 What emission standards must I meet? (a) Unless you comply with the standard using equipment specified in paragraphs (b) or (c) of this section, you must meet the applicable emission limits in paragraphs (a)(2) through (a)(3) of this section for volatile organic compounds (VOC) or (a)(4) through (a)(5) of this section for acetaldehyde emitted from the fermentation production line. (1) Prior to submitting your compliance certification under Sec. 63.9(h) (initial compliance), you must select whether you will monitor VOC or acetaldehyde. This selection will determine the applicable standards for your facility. Section 63.2165 contains additional information on the notification procedures you must follow in making your selection. (2) If you monitor VOC and construction of your fermentation production line commenced on or before October 19, 1998, you must limit VOC emissions from each line to 9.4 pounds per ton of liquid yeast produced (9.4 lb/ton LY) for each calendar month. (3) If you monitor VOC and construction or reconstruction of your fermentation production line commenced after October 19, 1998, you must limit VOC emissions from each line to 7.2 lb/ton LY for each calendar month. (4) If you monitor acetaldehyde and construction of your fermentation production line commenced on or before October 19, 1998, you must limit acetaldehyde emissions from each line to 1.7 lb/ton LY for each calendar month. (5) If you monitor acetaldehyde and construction or reconstruction of your fermentation production line commenced after October 19, 1998, you must limit acetaldehyde emissions from each line to 1.3 lb/ton LY for each calendar month. (b) If you use an incinerator to comply with the standard, you must maintain the minimum operating temperature established in Sec. 63.2142(a). (c) If you use a biofilter to comply with the standard, you must maintain the pressure drop within the complying pressure drop range established in Sec. 63.2142(a). Sec. 63.2136 When must I comply? (a) If construction of your fermentation production line commenced on or before October 19, 1998, you must comply on and after [Insert date 3 years from publication of final rule in Federal Register.] (b) If construction or reconstruction of your fermentation production line commenced after October 19, 1998, you must comply on and after [Insert date of publication of final rule in Federal Register] or on and after the date when you start operations, whichever is later. (c) If your fermentation production line becomes an affected source after October 19, 1998, you must comply on and after the date 3 years following the day it became an affected source, as defined by Sec. 63.2131. (d) If you can't meet a deadline, you may ask to extend the compliance date by following the criteria and procedures in Sec. 63.6(i). (e) You must comply with the provisions in this subpart at all times except during periods of start-up, shutdown, and malfunction (as defined in Sec. 63.2.) General Requirements for Compliance With the Emission Standards and for Monitoring and Performance Tests Sec. 63.2140 What general requirements must I meet to comply with the standard? (a) Process control. You may use process control to reduce VOC and acetaldehyde emissions and comply with the emission standard. ``Process control'' means reducing emissions of VOC and acetaldehyde by manipulating the flow of raw material, supply of oxygen, or some other input, thereby controlling fermentation. (b) Add-on control technology. As an alternative to process control, you may use an add-on control technology, such as incineration or biofiltration, to reduce VOC and acetaldehyde emissions and comply with the emission standard. (c) Showing compliance. Whether you use process or add-on controls, you must show initial and ongoing compliance with the emission standards in Sec. 63.2135. See the rest of this rule for procedures you must follow. (d) Operation and maintenance. You must comply with the operation and maintenance requirements in Sec. 63.6(e). (e) General Provisions. The General Provisions (40 CFR part 63, subpart A) apply to owners and operators of major sources of HAP emissions in all source categories, including nutritional yeast manufacturing. Table 1 of this section [[Page 55829]] lists the General Provisions that apply to nutritional yeast manufacturing facilities: Table 1 of Sec. 63.2140.--General Provisions That Apply to Subpart CCCC ------------------------------------------------------------------------ Applies to subpart Reference, subpart A general CCCC, 63.2130- Comment provisions 63.2229 ------------------------------------------------------------------------ 63.1-63.5...................... Yes. 63.6(a)-(g), (i)-(j)........... Yes. 63.6(h)(1)-(h)(6), (h)(8)- Yes. (h)(9). 63.7(h)(7)..................... No Sec. 63.6(h)(7), using continuous opacity monitoring, doesn't apply. 63.7........................... Yes. 63.8........................... Yes. 63.9........................... Yes. 63.10.......................... Yes. 63.11.......................... No Don't use flares to comply with the emission limits. 63.12-63.15.................... Yes. ------------------------------------------------------------------------ Sec. 63.2141 What monitoring must I do? (a) You must meet the requirements of Sec. 63.8. (b) You must install, calibrate, operate, and maintain all monitoring equipment according to manufacturer's specifications and the plan for startup, shutdown, and malfunctions that you must develop and use according to Sec. 63.6(e). (c) If you choose to continuously monitor VOC emissions, you must use Performance Specification 8 (PS 8), in appendix A of 40 CFR part 60, to show that your continuous emission monitoring system (CEMS) is operating properly. (1) Use EPA Method 25A, in appendix A of 40 CFR part 60, to do the relative-accuracy test PS 8 requires. (2) Calibrate the reference method and the CEMS with ethanol. (3) Collect a 1-hour sample for each reference-method test. (4) Set the CEMS span at 1.5 to 2.5 times the relevant emission limit. (d) If you choose to continuously monitor acetaldehyde emissions, you must use PS 9 or an approved alternative to show that your CEMS is operating properly. (e) If you are subject to Sec. 63.2135(a), you must continuously monitor either the air-flow rate or a parameter of the blower system correlated with the air-flow rate exiting each fermenter's exhaust stack. Use a calibrated annubar or other approved alternative to determine the air flow in the fermenter's exhaust stack. A ``fermenter's exhaust stack'' means the vent or ductwork that provides an outlet for gas from a fermenter. Sec. 63.2142 What performance tests must I complete? (a) Testing frequency. If you choose to comply with the standard using an add-on control technology, you must test its initial performance to show compliance with the emission limits in Sec. 63.2135(a)(2) and (a)(3), as applicable, and to establish baseline monitoring parameters that satisfy Secs. 63.2150 and 63.2155, as applicable. You must test the control device's performance while manufacturing the product that comprises the largest percentage of average annual production. Test the device's performance within 180 days from the compliance date that applies to you and test it again at least every 3 years or when process conditions change that would require a new correlation. (b) Approved test methods. You must follow the procedures in Secs. 63.7 and 63.8 and use one of the following test methods. Unless changed in this subpart, all EPA methods are in appendix A of part 60 of this chapter. (1) Use Method 1 to select the sampling port's location and the number of traverse points. (2) Use Method 2 to measure volumetric flow rate. (3) Use Method 3 for gas analysis to determine the dry molecular weight of the stack gas. (4) Use Method 4 to determine moisture content of the stack gas. 40 CFR part 60. (5) Use EPA Method 25A, or any alternative validated by EPA Method 301, to measure VOC as ethanol. (c) Additional requirements for performance tests. Make sure you: (1) Design the test to sample a complete batch. You must do three sampling runs for each of the three fermentation stages in a batch, as defined in this rule. (2) Do the test at a point in the exhaust-gas stream before you inject any dilution air, meaning any air not needed to control fermentation. (3) Record the results of each run of the performance test. Requirements for Showing Compliance Using Process Control Sec. 63.2145 If I use process control, how do I comply with the standard? (a) If you monitor VOC using procedures under Sec. 63.2141(c) and air flow using procedures under Sec. 63.2141(e), you must record the VOC concentration and air-flow rate in every fermenter's exhaust stack (or a correlated parameter.) Record data as 15-minute block averages values. To be valid, your monitoring must meet the following requirements: (1) Two 15-minute block values per hour. (2) Eighteen or more hours per day. (3) Eighteen or more days for each 30-day period. (b) You meet the applicable emission standards in Sec. 63.2135(a) if the calendar month average VOC emissions per ton of liquid yeast produced is no more than the limits in Sec. 63.2135(a)(2) and (a)(3) for each batch. You must calculate emissions using the following procedures: (1) Calculate emissions from each affected fermentation stage (E) using the following formula: [GRAPHIC] [TIFF OMITTED] TP19OC98.002 where: a(t)=air flow in the fermenter's exhaust stack at a particular time; [[Page 55830]] t0 and t1=the beginning and end, respectively, of the time period for the production of a batch; and c(t)=the concentration of VOC in the fermenter's exhaust stack at a particular time. (2) Calculate emissions from each batch (B) using the following formula: [GRAPHIC] [TIFF OMITTED] TP19OC98.003 where: n=the number of fermentation stages; Es=emissions (measured in pounds) from stage s; and Y=batch yield. ``Batch yield'' means a discrete quantity of yeast produced from the last fermentation stage of a batch operation and is expressed as tons of liquid yeast based on 30 percent solids. (3) Calculate the calendar month average using the following formula: [GRAPHIC] [TIFF OMITTED] TP19OC98.004 where: Omonth=the number of batch operations in a calendar month; and Bn=emissions from batch n. (c) If you monitor acetaldehyde using procedures under Sec. 63.2141(d) and air flow using procedures under Sec. 63.2141(e), you must record the acetaldehyde concentration and air-flow rate in every fermenter's exhaust stack (or a correlated parameter.) Record data as 15-minute block values. To be valid, your monitoring must meet the following requirements: (1) Two 15-minute block values per hour. (2) Eighteen or more hours per day. (3) Eighteen or more days for each 30-day period. (d) You meet the applicable emission standards in Sec. 63.2135(a) if the calendar month average VOC emissions per ton of liquid yeast produced is no more than the limits in Sec. 63.2135(a)(4) and (a)(5) for each batch. You must calculate emissions using the equations in paragraph (b) of this section, substituting acetaldehyde data for VOC data, where appropriate. Requirements for Incinerators Sec. 63.2150 If I use an incinerator, what monitoring must I do? (a) You must monitor and record the temperature in the main chamber and afterburner at least once every 15 minutes. (b) Make sure the monitoring equipment is installed and operating, and verify the data, before or during the performance test. To verify that your equipment is operating, you must meet at least one of the following standards: (1) The manufacturer's written specifications or recommendations for installing, operating, and calibrating the system. (2) Other written procedures that ensure reasonably accurate monitoring. (c) Install, operate, and maintain the monitoring equipment so it gives you representative measurements of parameters from the regulated sources. Sec. 63.2151 If I use an incinerator, how do I comply with the standard? (a) First, you must establish the minimum operating temperature for each combustion chamber and afterburner with a performance test under procedures in Sec. 63.2142. The minimum operating temperature is the average of the three test run values recorded under Sec. 63.2142(c). (b) Second, you must ensure that the temperature in each combustion chamber stays at or above the minimum operating temperature, based on 15-minute block values taken according to Sec. 63.2150. Requirements for Biofiltration Sec. 63.2155 If I use biofiltration, what monitoring must I do? (a) You must monitor and record the pressure drop across the biofiltration system at least once every 8 hours. (b) You must maintain the pressure drop across the biofiltration system within 5 percent and 1 inch of the water column of the complying pressure drop, or within the range of the complying values for pressure drop established during your initial performance test. ``Complying pressure drop'' means the pressure drop at which your system meets an emission standard. Sec. 63.2156 If I use biofiltration, how do I comply with the standard? (a) You must establish the complying pressure drop across the system during a performance test, following procedures in Sec. 63.2142. (b) For each biofiltration system, you may establish either of the following: (1) A range of complying pressure drops by conducting multiple compliance performance tests. (2) One complying pressure drop as the average pressure drop measured over three test runs of a single performance test. (c) The pressure drop across your system must stay within 5 percent and 1 inch of the water column of the complying pressure drop, or range established in your performance test. Requirements for Other Means of Monitoring Sec. 63.2160 How can I get approval for, and use, other means of monitoring? (a) Monitoring and recordkeeping. (1) Request and receive approval from the Administrator to use other monitoring methods, following Sec. 63.8(f). (2) Use the approved alternate monitoring procedure so you continuously meet the emission standard that applies to you. (3) Comply with monitoring and recordkeeping requirements the Administrator specifies. (b) Compliance demonstrations. (1) Do an initial performance test to show you meet the emission standard. (2) During any performance test, you must show that your monitoring method can determine whether your process controls or add-on controls meet the emission standard that applies to you. (3) Unless the Administrator specifies another schedule, test performance once per year. Reporting and Recordkeeping Requirements Sec. 63.2165 Which reports must I prepare? (a) You must follow the notification procedures in Sec. 63.9 and the reporting requirements in Sec. 63.10. If the Administrator hasn't delegated authority under subpart E of this part to your State, you must notify the EPA's appropriate regional office. If your State has delegated authority, notify your State and send copy of each notice to the appropriate EPA regional office. The regional office may waive this requirement. (b) Following the procedures in Sec. 63.9(h), within 60 days after completing the relevant compliance demonstration activity specified in Secs. 63.2145, 63.2151, or 63.2156, notify the Administrator of your initial compliance status. In the case of Sec. 63.2145, process control, you must report at least three months worth of complying data. (c) Annually, certify your compliance by reporting the following information: (1) How you determined compliance, including specific information about the parameters you monitored and the methods you used to monitor them. (2) The results of your monitoring procedures or methods. (3) How you will continue to comply including a description of monitoring and reporting requirements and test methods. (4) A statement attesting to whether your facility has complied with this regulation, signed by a responsible official who shall certify its accuracy. [[Page 55831]] Sec. 63.2166 What records must I maintain? (a) In addition to meeting the recordkeeping requirements under Sec. 63.10, you must record the following information in a daily log: (1) Operation time for all control devices and monitoring equipment. (2) Details of all routine and other maintenance on all control devices and monitoring equipment, including dates and duration of any outages. (3) The fermentation stage for which you're using each fermenter. (b) You must also record the information required to support your compliance demonstrations under Secs. 63.2145, 63.2151, and 63.2156. Sec. 63.2167 How long do I have to maintain records? You must keep all records available for inspection for at least 5 years--onsite for the most recent 2 years of operation. You may keep records for the previous 3 years off site. Delegation of Authorities Sec. 63.2170 What authorities may be delegated to the States? (a) In delegating implementation and enforcement authority to a State under subpart E of this part, the Administrator will retain the authorities contained in paragraph (b) of this section. (b) [Reserved]. Sec. 63.2171-63.2229 [Reserved] [FR Doc. 98-27700 Filed 10-16-98; 8:45 am] BILLING CODE 6560-50-P