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 Environmental Protection Agency 40 CFR Part 63
[FRL-6978-5]
RIN 2060-AF30
 AGENCY: Environmental Protection Agency (EPA).
 ACTION: Final rule.
 SUMMARY: This action finalizes national emission standards for hazardous air pollutants (NESHAP) for the nutritional yeast manufacturing source category. The EPA has identified the nutritional yeast manufacturing source category as a major source of hazardous air pollutants (HAP) emissions of acetaldehyde. These standards implement section 112(d) of the Clean Air Act (CAA) by requiring all major sources to meet HAP emission standards reflecting the application of the maximum achievable control technology (MACT). These final standards will eliminate approximately 13 percent of nationwide acetaldehyde emissions from these sources. Acute (short term) and chronic (long term) inhalation exposure to acetaldehyde is associated with adverse health effects including irritation of the eyes, skin, and respiratory tract. Acetaldehyde is a potential developmental toxin and a probable human carcinogen.
 EFFECTIVE DATE: May 21, 2001.
 ADDRESSES: Docket No. A-97-13 contains supporting information used in developing the standards for the nutritional yeast manufacturing source category. The docket is located at the U.S. Environmental Protection Agency, 401 M Street, SW., Washington, DC 20460 in Room M-1500, Waterside Mall (ground floor), and may be inspected from 8:30 a.m. to 5:30 p.m., Monday through Friday, excluding legal holidays.
 FOR FURTHER INFORMATION CONTACT: Mr. David W. Markwordt, Policy, Planning, and Standards Group, Emission Standards Division (MD-13), U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711, telephone number (919) 541-0837, facsimile (919) 541-0942, electronic mail address: 
                        *markwordt.david@epa.gov.*


SUPPLEMENTARY INFORMATION: *Docket.*
                     The docket is an organized and complete file of all the information considered by EPA in the development of this rulemaking. The docket is a dynamic file because material is added throughout the rulemaking process. The docketing system is intended to allow members of the public and industries involved to readily identify and locate documents so that they can effectively participate in the rulemaking process. Along with the proposed and promulgated standards and their preambles, the contents of the docket will serve as the record in the case of judicial review. (See section 307(d)(7)(A) of the CAA.) The regulatory text and other materials related to this rulemaking are available for review in the docket or copies may be mailed on request from the Air Docket by calling (202) 260-7548. A reasonable fee may be charged for copying docket materials. *World Wide Web (WWW).*
                     In addition to being available in the docket, an electronic copy of today's final rule will also be available on the WWW through the EPA's Technology Transfer Network (TTN). Following signature, a copy of the rule will be posted on the TTN's policy and guidance page for newly proposed or promulgated rules, 
                    *http://www.epa.gov/​ttn/​oarpg.*
                     The TTN provides information and technology exchange in various areas of air pollution control. If more information regarding the TTN is needed, call the TTN HELP line at (919) 541-5384. *Regulated entities.*
                     Categories and entities potentially affected by this action include: Category
SICa
NAICSb
Regulated entitiesIndustry
2099
311999
Manufacturers of varieties of 
                            *Saccharomyces cerevisiae*
                             nutritional yeast made for the purpose of becoming an ingredient in dough for bread or other yeast-raised baked product, and for becoming a nutritional food additive.a
                         Standard Industrial Classificationb
                         North American Industry Classification System
 This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. To determine whether your facility is regulated by this action, you should examine the applicability criteria in § 63.2131 of the final rule. *Judicial Review.*
                     Under section 307(b) of the CAA, judicial review of this final rule is available only by filing a petition for review in the United States Court of Appeals for the District of Columbia Circuit by July 20, 2001. Under section 307(d)(7)(B) of the CAA, only an objection to this rule which was raised with reasonable specificity during the period for public comment can be raised during judicial review. Moreover, under section 307(b)(2) of the CAA, the requirements established by today's final action may not be challenged separately in any civil or criminal proceeding we bring to enforce these requirements. *Outline.*
                     The information presented in this preamble is organized as follows: I. Background A. What is the source of authority for development of NESHAP? B. What criteria do we use in the development of NESHAP? II. What are the HAP emissions and health effects associated with the HAP emitted? III. What are the final standards? A. What is the source category? B. What is the affected source? C. What are the emission limits? D. What are the testing and initial and continuous compliance requirements? E. What are the notification, recordkeeping, and reporting requirements? IV. What major changes have we made to the rule since proposal? A. Regulation Format B. Emission Limit Standard C. No Wastewater Requirements D. Brew Ethanol Monitoring E. MACT Requirements F. Compliance Requirements V. What are the environmental, energy, cost, and economic impacts? A. What are the air quality impacts? B. What are the non-air health, environmental, and energy impacts? C. What are the cost and economic impacts? VI. Administrative Requirements A. Executive Order 12866, Regulator Planning and Review B. Executive Order 13132, Federalism C. Executive Order 13175, Consultation and Coordination with Indian Tribal Governments D. Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks E. Unfunded Mandates Reform Act of 1995 F. Regulatory Flexibility Act (RFA), as Amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 
                        *et seq.* G. Paperwork Reduction Act H. National Technology Transfer and Advancement Act I. Congressional Review Act I. Background A. What Is the Source of Authority for Development of NESHAP? Section 112 of the CAA requires us to list categories and subcategories of major sources and area sources of HAP and to establish NESHAP for the listed source categories and subcategories. Major sources of HAP are those that have the potential to emit greater than 
                    ( print page 27878)
                    9 Megagrams per year (Mg/yr) (10 tons per year (tpy)) of any one HAP or 23 Mg/yr (25 tpy) of any combination of HAP. The “baker's yeast manufacturing” source category was listed as a major source of HAP on the initial source category list published in the 
                    **Federal Register**
                     on July 16, 1992 (57 FR 31576). We changed the name of the source category to “manufacturing of nutritional yeast” in order to clarify the scope of the rule and distinguish it as not including the regulation of bakeries. B. What Criteria Do We Use in the Development of NESHAP? Section 112 of the CAA requires that we establish NESHAP for the control of HAP from both new and existing major sources. The CAA requires the NESHAP to reflect the maximum degree of reduction in emissions of HAP that is achievable. This level of control is commonly referred to as the MACT. The MACT floor is the minimum control level allowed for NESHAP and is defined under section 112(d)(3) of the CAA. In essence, the MACT floor ensures that the standard is set at a level that assures that all major sources achieve the level of control at least as stringent as that already achieved by the better-controlled and lower-emitting sources in each source category or subcategory. For new sources, the MACT floor cannot be less stringent than the emission control that is achieved in practice by the best-controlled similar source. In developing MACT, we also consider control options that are more stringent than the floor. We may establish standards more stringent than the floor based on the consideration of cost of achieving the emissions reductions, any non-air quality health and environmental impacts, and energy impacts. II. What Are the HAP Emissions and Health Effects Associated With the HAP Emitted? The HAP emitted from the nutritional yeast manufacturing process is acetaldehyde. We have estimated the annual acetaldehyde emissions from the manufacture of nutritional yeast to be approximately 220 Mg/yr (240 tpy). Acetaldehyde acute (short term) exposure is associated with irritation of the eyes, skin, and respiratory tract. Acute inhalation of high concentrations of acetaldehyde can cause respiratory paralysis and death. Animal acetaldehyde exposure studies indicate that acetaldehyde may also be a developmental toxin. Rats and hamsters with chronic (long-term) exposure to acetaldehyde have an increased incidence of nasal and laryngeal tumors. Based on animal studies, we have classified acetaldehyde as a probable human carcinogen of low carcinogenic hazard. III. What Are the Final Standards? A. What Is the Source Category? We have defined the nutritional yeast manufacturing source category to include facilities that manufacture varieties of 
                    *Saccharomyces cerevisiae*
                     (also referred to as nutritional yeast, or baker's yeast) that are made for the purpose of becoming an ingredient in dough for bread or other yeast-raised baked products, or for becoming a nutritional food additive intended for consumption by humans. The nutritional yeast manufacturing source category does not include the production of yeast intended for consumption by animals (for example, as an additive for livestock feed). B. What Is the Affected Source? We have defined the nutritional yeast manufacturing affected source as including the collection of equipment used in the manufacture of nutritional yeast species 
                    *Saccharomyces cerevisiae.*
                     This collection of equipment includes, but is not limited to, fermentation vessels (fermenters). We have not included the collection of equipment used in the manufacture of nutritional yeast species 
                    *Candida utilis*
                     (torula yeast) as part of the affected source. C. What Are the Emission Limits? For existing and new sources, we are requiring that you meet volatile organic compound (VOC) emission limits as a surrogate for acetaldehyde, which makes up a portion of the total VOC emitted. The emission limitations include both VOC concentration limits and a percent-of-batches requirement. The concentration limits apply to each batch; they are expressed as the VOC concentration averaged over the duration of a batch. The fermentation stage of each batch determines which one of three VOC concentration limits is applicable to that batch. To meet the percent-of-batches requirement, you must ensure that at least 98 percent of batches on a rolling 12-month average are within-concentration batches. (We define a “within-concentration batch” as a batch for which the average VOC concentration is not higher than the maximum concentration that is allowed as the 98 percent emission limitation.) D. What Are the Testing and Initial and Continuous Compliance Requirements? To demonstrate compliance with the VOC emission limits specified in the rule, we require that you monitor either the VOC concentration in the fermenter exhaust or the brew ethanol concentration in the fermenter. (We define “brew ethanol” as the ethanol in the fermenter liquid.) If you monitor brew ethanol, you must conduct performance tests simultaneously with brew ethanol monitoring to establish a brew-to-exhaust correlation. (The “brew-to-exhaust correlation” is the correlation between the concentration of ethanol in the brew and the concentration of VOC in the fermenter exhaust.) If you monitor fermenter exhaust, you must ensure that at least 98 percent of batches over the initial compliance period are within-concentration batches to demonstrate initial compliance with the emission limitations. If you monitor brew ethanol, you must ensure that the VOC fermenter exhaust concentration over the period of your performance test does not exceed the applicable maximum concentration. You must also have a record of the brew-to-exhaust correlation during the performance test while the VOC fermenter exhaust concentration is at or below the applicable maximum concentration. To demonstrate continuous compliance with the emission limitations, you must report the percentage of batches that are within-concentration batches, based on a 12-month rolling time period. Your continuous emission monitoring system (CEMS) must be operated at all times during a fermentation batch monitoring period. If you monitor brew ethanol, you must correlate the brew ethanol concentration measured by the CEMS, by testing, to the VOC concentration in the fermenter exhaust. The brew-to-exhaust correlation will determine the brew ethanol concentration CEMS compliance monitoring limit. You are required to determine this correlation at least once a year. E. What Are the Notification, Recordkeeping, and Reporting Requirements? We require owners or operators of nutritional yeast manufacturing affected sources to which the final rule applies to submit the following: (1) Application for Approval of Construction or Reconstruction, (2) Notification of Compliance Status, (3) Compliance Reports, and (4) Immediate Malfunction Reports. Additionally, if an owner or 
                    ( print page 27879)
                    operator intends to conduct a performance evaluation or performance test, we require notification of such intent. Records of reported information and other information necessary to document compliance (
                    *e.g.,*
                     records related to malfunction, records that show continuous compliance with emission limits) must be maintained for 5 years. As soon as practicable before construction begins, you must submit an application for approval of construction of a new major affected source, reconstruction of a major affected source, or reconstruction of a major source such that the source becomes a major affected source subject to the rule. You must submit a separate application for each construction or reconstruction. You must submit at least your name and address, the details regarding your intent to construct or reconstruct, the address of the proposed construction or reconstruction, identification of the standard(s) that are the basis for the application, the expected commencement and completion of the construction or reconstruction, the anticipated date of startup of the source, and the type and quantity of HAP that are anticipated by the source. You must provide us with a one-time notification of compliance with the final rule. It must describe how you are compliant with the rule, including results of initial compliance determination, identification of the method to be used to determine continuing compliance, and description of the air pollution control method employed. You must report on your continued compliance status semiannually. This report must include your calculated percentage of within-concentration batches for 12-month calculation periods ending on each calendar month that falls within the reporting period. If you had a malfunction during the reporting period and you took actions as specified in your malfunction plan, you must include that information in the Compliance Report (CR). If you have a malfunction during the reporting period that is not specified in your malfunction plan, you must submit an Immediate Malfunction Report. This report consists of a telephone call (or facsimile (FAX) transmission) to the Administrator within 2 working days after starting actions that are not included with your plan and shall describe the actions taken during the malfunction event, followed by a letter within 7 working days after the end of the event. If you intend to conduct a performance evaluation or performance test, you are required to submit a notification of such intent at least 60 days prior to the evaluation or test. IV. What Major Changes Have We Made to the Rule Since Proposal? In response to comments received on the proposed standards, we made several changes to the final rule. While some of the changes we made were clarifications designed to make our intentions clearer, some of the changes are changes to the proposed standard requirements. The substantive comments and/or changes and responses made since the proposal are summarized in the following sections. Our complete responses to public comments are contained in a memorandum that can be obtained from the docket (see 
                    **ADDRESSES**
                     section). A. Regulation Format We have changed the regulatory format of the rule from what was proposed on October 19, 1998 (63 FR 55812) to improve implementation, permitting, and enforcement of the rule. The new format also improves the interface with the 40 CFR part 63 General Provisions which are cross-referenced in the proposed and final rule. Although the overall format of the final rule differs from the format of the proposal, unless noted in another paragraph of this section, the requirements are the same. We believe that the new format increases the clarity of the requirements and eases the implementation burden of the rule for both the regulated entity and enforcing agency. B. Emission Limit Standard We proposed two sets of emission limits and associated requirements for the nutritional yeast manufacturing source category. Both sets of emission limits potentially represented MACT. One set, which we referred to in the proposal preamble as the “Reasonably Available Control Technology (RACT) standard,” relies on the concentration-based limits used in Wisconsin's and Maryland's RACT rules. The second set, which we referred to in the proposal preamble as the “Presumptive MACT (PMACT) standard,” relies on a production-based format, which is the same format we considered in the 1994 PMACT. Two commenters supported the use of the PMACT standard option, and two commenters supported the retention of both options in the final rule. Two of the commenters supported the PMACT standard option because they objected to the proposed RACT option's air flow measurement requirement and air flow cap. One of the commenters added that they would only support the PMACT option if the production-linked emission factor compliance requirement was to be kept confidential. One of the commenters that recommended retaining both options in the final rule stated that they would prefer the RACT option over the PMACT option if the concentration limits were expressed in terms of propane and the air flow limitation was removed. Based on comments received and further evaluation of these two options, we decided to adopt the RACT standard option, without the air flow cap, in the final rule because it offers a direct measure of compliance, does not require calculations based on confidential production data, and is simpler as well as easier to use and enforce than the PMACT standard option. Additionally, as noted at proposal, we have more data to support the RACT option. We have selected the RACT standard option because we also believe it better reflects existing control technology performance, operation, and batch emissions variability. C. No Wastewater Requirements At proposal, we solicited comment on regulating wastewater and what would constitute MACT for nutritional yeast manufacturing facilities. We received three comment letters that argued against the regulation of wastewater emissions of acetaldehyde at nutritional yeast manufacturing facilities. Reasons given for not regulating wastewater emissions include that the cost of monitoring and control of emissions of acetaldehyde would be high, that emissions from wastewater of acetaldehyde are insignificant, and that treatment might increase emissions of other air pollutants. Based on comments received and further analysis of wastewater acetaldehyde emissions from nutritional yeast manufacturing facilities, we concluded that the MACT floor for wastewater emissions is no control. We then considered going beyond the floor and determined that non-air quality health and environmental impacts, energy impacts, and costs to go beyond the floor are unreasonably high (Docket No. A-97-13). The amount of acetaldehyde in the wastewater is a function of the acetaldehyde generated during the yeast fermentation process. Acetaldehyde is a by-product of the fermentation process. Emission limits on the fermentation process result in lower air emissions from the fermentation tanks. To achieve the emission limits, facilities must regulate the yeast growth by process 
                    ( print page 27880)
                    control of sugar and oxygen to the yeast. This process control also results in lower concentrations of acetaldehyde in the wastewater and subsequently lower air emissions from wastewater. Thus, levels of acetaldehyde in wastewater are already reduced by process changes upstream of wastewater management operations (which process controls constitute MACT for those operations). Put another way, achieving the upstream standards also controls acetaldehyde in wastewater. The standard of “no control” in the final rule for wastewater operations thus means no additional control beyond that already afforded through the upstream standards. Further control of wastewater emissions is achievable through use of add-on emission control technologies. No such controls are currently utilized, so that any such control would be a beyond-the-floor standard. Given the small concentrations of acetaldehyde remaining in wastewater, EPA believes any such controls would not be cost effective. In addition, there are no non-air quality impact or energy considerations that would suggest adopting such beyond-the-floor controls (which would require additional energy to operate and generate a waste stream for disposal). Therefore, we do not require control of emissions of acetaldehyde from wastewater in the final rule. D. Brew Ethanol Monitoring One commenter requested that the measurement of ethanol in fermenter liquid be allowed as an alternative to measurement of VOC in fermenter offgas. The commenter supplied information to us that indicated a strong correlation between the brew ethanol concentration in the fermenter liquid and the VOC concentration in the fermenter exhaust. Upon evaluation of the commenter's documentation and our own analysis, we agreed that the correlation between brew ethanol and VOC concentration from the fermenter exhaust is sufficiently strong to allow monitoring of brew ethanol as an alternative to monitoring VOC concentration. Therefore, the final rule explicitly allows for the measurement of brew ethanol as an alternative monitoring method. E. MACT Requirements Some commenters expressed that surrogate VOC concentration limits should be established based on what is achievable in practice. Nutritional yeast manufacturing facilities currently subject to RACT standards or RACT-like standards represent the best-controlled sources for the nutritional yeast manufacturing source category (Docket No. A-97-13). Some States with RACT or RACT-like standards apply discretion as to whether a concentration limit that is exceeded results in a violation of the standard (a VOC concentration limit is exceeded if the batch-average concentration exceeds the specified limit). For example, Maryland's continuous emissions monitoring policy allows for one VOC concentration limit exceedance, or occurrence, per facility per quarter. We did not receive any comments that supported lowering MACT concentration limits from RACT concentration limits. One commenter stated that although most batches display batch-average VOC concentrations below the RACT limits due to the natural variability of the biological process of yeast-growing, batch-average VOC concentrations display a bell-curve distribution. The commenter added that because of the bell-curve distribution of VOC concentrations, a source needs to target VOC concentrations well below the RACT limit in order for the distribution of actual concentrations to remain below the RACT limit. We analyzed available information for five yeast manufacturing facilities that are subject to Wisconsin or Maryland RACT standards or California Bay Area Air Quality Management District (BAAQMD) RACT-like concentration limits. Based on our analysis, we found that these facilities had concentration limits that were exceeded for 0 to 2.5 percent of their runs, with an average of 1.3 percent of the concentration limits being exceeded for the total number of runs in 1998. Only one facility had no concentration limits that were exceeded (Docket No. A-97-13). There is no evidence that failure to meet the limit for every batch is a result of poor operation. We do not have sufficient data to indicate that the RACT limits can be achieved on every batch, so we have concluded that the MACT floor for the nutritional yeast manufacturing source category, for existing and new sources, is less stringent than meeting the RACT limits for every batch (Docket No. A-97-13). Therefore, we have concluded that MACT is the control of 98 percent of the batches to either at or below the VOC concentration limits specified in the rule. F. Compliance Requirements Many comments were received regarding compliance requirements. Some commenters requested that the final rule clarify the compliance period over which the concentration limits are to be met. Other commenters stated that the proposed concentration limit for VOC (as ethanol) under the RACT standard option was based on an incorrect conversion of VOC to an ethanol basis from the propane basis that is used in the RACT rules. We agree that the final rule should clarify the compliance period for which the concentration limits must be met. As explained above, the MACT level of control is that 98 percent of the nutritional yeast manufacturing batches be lower than or equal to concentration limits established in the rule. This level of control was determined to be achievable on a rolling 12-month average basis. Therefore, the final rule clarifies that the concentration limits are to be met on the basis of an average of concentrations measured over the duration of a batch, and not on an instantaneous basis. Ninety-eight percent of the nutritional yeast manufacturing batches are to be within concentration limits on a rolling 12-month average basis. We proposed limits in terms of VOC as ethanol. From information and comments received after proposal, we learned that the use of propane-calibrated analyzers is widespread in the nutritional yeast manufacturing industry, and that their use is consistent with the RACT requirements which represent MACT. Therefore, the final rule expresses concentration limits based on VOC as propane rather than as ethanol. V. What Are the Environmental, Energy, Cost, and Economic Impacts? A. What Are the Air Quality Impacts? We estimate that the 1998 nationwide emissions from nutritional yeast manufacturing facilities were approximately 820 Mg/yr (900 tpy) of VOC and 220 Mg/yr (240 tpy) of acetaldehyde. The final rule will reduce VOC emissions by an estimated 85 Mg/yr (93 tpy) and acetaldehyde emissions by an estimated 28 Mg/yr (31 tpy) from nutritional yeast manufacturing facilities. B. What Are the Non-Air Health, Environmental, and Energy Impacts? We do not expect that there will be any significant adverse non-air health, environmental or energy impacts associated with the final standards for the nutritional yeast manufacturing source category. We determine impacts relative to the baseline that is set at the level of control in absence of the rule. The predominant control measure that will be adopted by nutritional yeast 
                    ( print page 27881)
                    manufacturing facilities as a result of the final rule is process control, which will not result in any water pollution or solid waste impacts. C. What Are the Cost and Economic Impacts? The total estimated capital cost of the final rule for the nutritional yeast manufacturing source category is approximately $270,000. The total estimated annual cost of the final rule is approximately $700,000 (Docket No. A-97-13). We do not expect any adverse economic impacts to result from the final rule. VI. Administrative Requirements A. Executive Order 12866, Regulatory Planning and Review 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) and the requirements of the Executive Order. 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; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order. Pursuant to the terms of Executive Order 12866, it has been determined that this rule is not a “significant regulatory action” under the terms of Executive Order 12866. Consequently, this action was not submitted to OMB for review under Executive Order 12866. B. Executive Order 13132, Federalism Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” Policies that have federalism implications is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under Executive Order 13132, the EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or the EPA consults with State and local officials early in the process of developing the regulation. The EPA also may not issue a regulation that has federalism implications and that preempts State law unless the Agency consults with State and local officials early in the process of developing the regulation. If the EPA complies by consulting, Executive Order 13132 requires the EPA to provide to OMB, in a separately identified section of the preamble to the rule, a federalism summary impact statement (FSIS). The FSIS must include a description of the extent of the EPA's prior consultation with State and local officials, a summary of the nature of their concerns and the Agency's position supporting the need to issue the regulation, and a statement of the extent to which the concerns of State and local officials have been met. Also, when the EPA transmits a draft final rule with federalism implications to OMB for review pursuant to Executive Order 12866, the EPA must include a certification from the Agency's Federalism Official stating that the EPA has met the requirements of Executive Order 13132 in a meaningful and timely manner. This final rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. This final rule is mandated by statute and does not impose requirements on States; however, States will be required to implement the rule by incorporating the rule into permits and enforcing the rule upon delegation. States will collect permit fees that will be used to offset the resource burden of implementing the rule. Thus, the requirements of section 6 of the Executive Order do not apply to this rule. Although section 6 of Executive Order 13132 does not apply to this rule, the EPA did consult with State and local officials in developing this rule. C. Executive Order 13175, Consultation and Coordination With Indian Tribal Governments On November 6, 2000, the President issued Executive Order 13175 (65 FR 67249) entitled, “Consultation and Coordination with Indian Tribal Governments.” Executive Order 13175 took effect on January 6, 2001, and revokes Executive Order 13084 (Tribal Consultation) as of that date. The EPA developed this final rule, however, during the period when Executive Order 13084 was in effect; thus, EPA addressed tribal considerations under Executive Order 13084. Under Executive Order 13084, the EPA 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, or we consult with those governments. If the EPA complies by consulting, Executive Order 13084 requires the EPA to provide to OMB, in a separately identified section of the preamble to the rule, a description of the extent of the 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 the EPA to develop an effective process permitting elected officials 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.” These final standards do not significantly or uniquely affect the communities of Indian tribal governments. No tribal governments own or operate nutritional yeast manufacturing facilities. Accordingly, the requirements of Executive Order 13084 do not apply to this action. D. Executive Order 13045, Protection of Children From Environmental Health Risks and Safety Risks Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any rule that (1) is determined to be “economically significant,” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that 
                    ( print page 27882)
                    EPA has reason to believe may have 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 rule is preferable to other potentially effective and reasonable alternatives considered by the Agency. The EPA interprets Executive Order 13045 as applying only to those regulatory actions that are based on health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation. These final standards are not subject to Executive Order 13045 because they are based on technology performance and not on health or safety risks. No children's risk analysis was performed because no alternative technologies exist that would provide greater stringency at a reasonable cost. Furthermore, this rule has been determined not to be “economically significant” as defined under Executive Order 12866. E. Unfunded Mandates Reform Act of 1995 Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 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, the EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures by State, local, and tribal governments, in aggregate, or by the private sector, of $100 million or more in any 1 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 the EPA 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 as to why that alternative was not adopted. Before the EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it 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 officials of affected small governments to have meaningful and 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. Today's final rule contains no 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 1 year. The maximum total annual cost of this rule for any year has been estimated to be less than $700,000. Thus, today's final rule is not subject to the requirements of sections 202 and 205 of the UMRA. In addition, the EPA has determined that this final rule contains no regulatory requirements that might significantly or uniquely affect small governments because it contains no regulatory requirements that apply to such governments or impose obligations upon them. Therefore, today's final rule is not subject to the requirements of section 203 of the UMRA. Because this final rule does not include a Federal mandate and is estimated to result in expenditures less than $100 million in any 1 year by State, local, and tribal governments, the EPA has not prepared a budgetary impact statement or specifically addressed the selection of the least costly, most cost-effective, or least burdensome alternative. In addition, because small governments will not be significantly or uniquely affected by this rule, the EPA is not required to develop a plan with regard to small governments. Therefore, the requirements of the UMRA do not apply to this action. F. Regulatory Flexibility Act (RFA), as Amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et seq. The EPA has determined that it is not necessary to prepare a regulatory flexibility analysis in connection with this final rule. The EPA has also determined that this rule will not have a significant economic impact on a substantial number of small entities. For purposes of assessing the impacts of today's rule on small entities, a small entity is defined as: (1) A small business that has fewer than 500 employees; (2) a small governmental jurisdiction that is a government of a city, county, town, school district, or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. The small business size standards are based on industries as they are defined in NAICS and were published in a final rule by the Small Business Administration on September 5, 2000 (65 FR 53533). After considering the economic impacts of today's final rule on small entities, EPA has concluded that this action will not have a significant impact on a substantial number of small entities. Although there appears to be one small business in the nutritional yeast manufacturing industry, the complex ownership issues involved with this firm makes the absolute determination uncertain. The EPA thus concludes that there is at the most one small business which may be affected by these standards. Individual company cost-to-sales ratio data is considered confidential business information (CBI) and may not be disclosed. The industry average cost-to-sales ratio for all affected companies is less than 0.3 percent. No individual company is anticipated to incur a cost-to-sales ratio exceeding 3 percent. Based on the foregoing, the EPA concludes that this rule will not have a significant impact on a substantial number of small businesses. Although this final rule will not have a significant impact on a substantial number of small entities, EPA nonetheless has tried to reduce the impact of this rule on small entities by providing alternatives to compliance and monitoring requirements. G. Paperwork Reduction Act The information collection requirements for these final standards will be submitted for approval to the Office of Management and Budget under the requirements of the Paperwork Reduction Act, 44 U.S.C. 3501 
                    *et seq.*
                     An Information Collection Request (ICR) document has been prepared by EPA (ICR No. 1886.02) for the nutritional yeast manufacturing source category and copies may be obtained from Ms. Sandy Farmer by mail at the U.S. Environmental Protection Agency, Office of Environmental Information, Collection Strategies Division (2822), 1200 Pennsylvania Avenue, NW., Washington, DC 20460, by e-mail at farmer.sandy@epa.gov, or by calling (202) 260-2740. A copy may also be downloaded off the internet at 
                    *http://www.epa.gov/​icr*. The information requirements are not effective until OMB approves them. The information requirements are based on notification, recordkeeping, and reporting requirements in the NESHAP General Provisions (40 CFR part 63, subpart A), which are 
                    ( print page 27883)
                    mandatory for all operators subject to national emission standards. These recordkeeping and reporting requirements are specifically authorized by section 114 of the CAA (42 U.S.C. 7414). The final standards require owners or operators of affected sources to retain records for a period of 5 years. The 5-year retention period is consistent with the General Provisions of 40 CFR part 63 and with the 5-year record retention requirement in the operating permit program under title V of the CAA. Total estimated annualized capital monitoring, inspection, reporting and recordkeeping (MIRR) costs for new and existing sources is $886,307 for the first years after promulgation of the NESHAP for this source category. Of the total estimated MIRR cost, $440,917 is labor dollars and $445,390 is capital and operation and maintenance. The annual public reporting and recordkeeping burden for this collection of information (averaged over the first 3 years after the effective date of the promulgated rule) is estimated to total 3,459 labor hours per year at a total annual cost of $146,972. This estimate includes notifications, performance evaluations and tests, compliance reports, and records of CEMS measurements. The total estimated annualized capital monitoring, inspection, reporting and recordkeeping (MIRR) costs for existing and new major sources to comply with the promulgated standards when an affected source opts to comply by using process add-on control equipment are determined based on the estimated capital costs of VOC monitoring equipment required for MIRR activities. For the yeast manufacturing industry, the total estimated installed capital costs of this equipment is $2,453,174 for existing major sources, and $0 for new major sources because we do not anticipate construction of any new major sources in the near future. Annualized capital MIRR costs for existing and new major sources to comply with the promulgated standard using process control were estimated to be $89,782 and $0, respectively, when averaged over the first 3 years after the effective date of the promulgated rule. The total annual estimated operating and maintenance costs (O&M) were calculated based on (1) the estimated postage costs for the estimated total annual responses associated with the provisions of the yeast manufacturing NESHAP and (2) the estimated annual cost of contracting for performance testing required for compliance with this standard. Annual O&M costs for existing and new major sources were estimated to be $58,682 and $0, respectively, when averaged over the first 3 years after the effective date of the promulgated rule. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to (1) review instructions; (2) develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; (3) adjust the existing ways to comply with any previously applicable instructions and requirements; (4) train personnel to be able to respond to a collection of information; (5) search data sources; (6) complete and review the collection of information; and (7) transmit or otherwise disclose the information. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for our regulations are listed in 40 CFR part 9 and 48 CFR chapter 15. The OMB control number(s) for the information collection requirements in this rule will be listed in an amendment to 40 CFR part 9 or 48 CFR Chapter 15 in a subsequent 
                    **Federal Register**
                     document after OMB approves the ICR. H. National Technology Transfer and Advancement Act Section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) of 1995 (Public Law 104-113; 15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in their regulatory and procurement 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, business practices) developed or adopted by one or more voluntary consensus bodies. The NTTAA directs EPA to provide Congress, through annual reports to OMB, with explanations when an agency does not use available and applicable voluntary consensus standards. This rulemaking involves the following technical standards: EPA Methods 25A, PS 8, PS 9, and a method for determining ethanol in liquids. Consistent with the NTTAA, the EPA conducted searches to identify voluntary consensus standards in addition to these EPA methods. The search for emissions monitoring procedures identified two voluntary consensus standards, both for EPA Method 25A. The EPA determined that one of these two standards, (EN 12619:1999), identified for measuring emissions of HAP or surrogates subject to emission standards in this rule, would not be practical due to lack of equivalency, detail, and/or quality assurance and/or quality control requirements. Therefore, we did not use this voluntary consensus standard in this rulemaking. The other consensus standard (ISO/FDIS 14965) identified for EPA Method 25A is under development. Therefore, we did not use this voluntary consensus standard in this rulemaking. No voluntary consensus standards were identified for PS 8, PS 9, or a procedure to determine ethanol in liquids. The search and review results have been documented and are placed in the Docket No. A-97-13 (see 
                    **ADDRESSES**
                     section) for this rule. Sections 63.2161 and 63.2163 of the standards list the EPA test methods and performance standards included in this rulemaking. Most of the standards have been used by States and industry for more than 10 years. I. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801, 
                    *et seq.*, as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the 
                    **Federal Register**
                    . A major rule cannot take effect until 60 days after it is published in the 
                    **Federal Register**
                    . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective May 21, 2001. List of Subjects in 40 CFR Part 63 Environmental protection
Administrative practice and procedures
Air emissions control
Hazardous air pollutants
Intergovernmental relations
Recordkeeping and reporting requirements
 Dated: May 8, 2001. Christine Todd Whitman, Administrator.
 For the reasons set out in the preamble, title 40, chapter I, part 63, of the Code of Federal Regulations is amended as follows: PART 63—[AMENDED]
 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 to read as follows: Subpart CCCC—National Emission Standards for Hazardous Air Pollutants: Manufacturing of Nutritional Yeast
 What This Subpart Covers63.2130
                        What is the purpose of this subpart?
                        63.2131
                        Am I subject to this subpart?
                        63.2132
                        What parts of my plant does this subpart cover?
                        63.2133
                        When do I have to comply with this subpart?
                        Emission Limitations63.2140
                        What emission limitations must I meet?
                        General Compliance Requirements63.2150
                        What are my general requirements for complying with this subpart?
                        Testing and Initial Compliance Requirements63.2160
                        By what date must I conduct an initial compliance demonstration?
                        63.2161
                        What performance tests and other procedures must I use if I monitor brew ethanol?
                        63.2162
                        When must I conduct subsequent performance tests?
                        63.2163
                        If I monitor fermenter exhaust, what are my monitoring installation, operation, and maintenance requirements?
                        63.2164
                        If I monitor brew ethanol, what are my monitoring installation, operation, and maintenance requirements?
                        63.2165
                        How do I demonstrate initial compliance with the emission limitations if I monitor fermenter exhaust?
                        63.2166
                        How do I demonstrate initial compliance with the emission limitations if I monitor brew ethanol?
                        Continuous Compliance Requirements63.2170
                        How do I monitor and collect data to demonstrate continuous compliance?
                        63.2171
                        How do I demonstrate continuous compliance with the emission limitations?
                        Notifications, Reports, And Records63.2180
                        What notifications must I submit and when?
                        63.2181
                        What reports must I submit and when?
                        63.2182
                        What records must I keep?
                        63.2183
                        In what form and how long must I keep my records?
                        Other Requirements And Information63.2190
                        What parts of the General Provisions apply to me?
                        63.2191
                        Who implements and enforces this subpart?
                        63.2192
                        What definitions apply to this subpart?
                        TablesTable 1 to Subpart CCCC—Emission Limitations
                        Table 2 to Subpart CCCC—Requirements for Performance Tests (Brew Ethanol Monitoring Only)
                        Table 3 to Subpart CCCC—Initial Compliance With Emission Limitations
                        Table 4 to Subpart CCCC—Continuous Compliance with Emission Limitations
                        Table 5 to Subpart CCCC—Requirements for Reports
                        Table 6 to Subpart CCCC—Applicability of General Provisions to Subpart CCCC
 What This Subpart Covers § 63.2130
  This subpart establishes national emission limitations for hazardous air pollutants emitted from manufacturers of nutritional yeast. This subpart also establishes requirements to demonstrate initial and continuous compliance with the emission limitations.
 § 63.2131
  (a) You are subject to this subpart if you own or operate a nutritional yeast manufacturing facility that is, is located at, or is part of a major source of hazardous air pollutants (HAP) emissions. (1) A manufacturer of nutritional yeast is a facility that makes yeast 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 intended for consumption by humans. A manufacturer of nutritional yeast does not include production of yeast intended for consumption by animals, such as an additive for livestock feed. (2) A major source of HAP emissions is 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, any single HAP at a rate of 9.07 megagrams (10 tons) or more per year or any combination of HAP at a rate of 22.68 megagrams (25 tons) or more per year. (b) [Reserved]
 § 63.2132
  (a) This subpart applies to each new, reconstructed, or existing “affected source” that produces 
                            *Saccharomyces cerevisiae*
                             at a nutritional yeast manufacturing facility. (b) The affected source is the collection of equipment used in the manufacture of the nutritional yeast species 
                            *Saccharomyces cerevisiae.*
                             This collection of equipment includes, but is not limited to, fermentation vessels (fermenters). The collection of equipment used in the manufacture of the nutritional yeast species 
                            *Candida utilis*
                             (torula yeast) is not part of the affected source. (c) The emission limitations in this subpart apply to fermenters in the affected source that meet all of the criteria listed in paragraphs (c)(1) through (2) of this section. (1) The fermenters are “fed-batch” as defined in § 63.2192. (2) The fermenters are used to support one of the last three fermentation stages in a production run, which may be referred to as “stock, first generation, and trade,” “seed, semi-seed, and commercial,” or “CB4, CB5, and CB6” stages. (d) The emission limitations in this subpart do not apply to flask, pure-culture, yeasting-tank, or any other set-batch fermentation, and they do not apply to any operations after the last dewatering operation, such as filtration. (e) The emission limitations in this subpart do not apply to the affected source during the production of specialty yeast (defined in § 63.2192). (f) An affected source is a “new affected source” if you commenced construction of the affected source after October 19, 1998, and you met the applicability criteria in § 63.2131 at the time you commenced construction. (g) An affected source is “reconstructed” if you meet the criteria as defined in § 63.2. (h) An affected source is “existing” if it is not new or reconstructed.
 § 63.2133
  (a) If you have a new or reconstructed affected source, you must comply with paragraphs (a)(1) through (2) of this section. (1) If you start up your affected source before May 21, 2001, then you must comply with the emission limitations in this subpart no later than May 21, 2001. (2) If you start up your affected source after May 21, 2001, then you must comply with the emission limitations in this subpart upon startup of your affected source.
                            ( print page 27885) (b) If you have an existing affected source, you must comply with the emission limitations for existing sources no later than May 21, 2004. (c) If you have an area source that increases its emissions, or its potential to emit, so that it becomes a major source of HAP, paragraphs (c)(1) through (2) of this section apply. (1) Any portion of the existing facility that is a new affected source or a new reconstructed source must be in compliance with this subpart upon startup. (2) All other parts of the source must be in compliance with this subpart by not later than 3 years after it becomes a major source. (d) You must meet the notification requirements in § 63.2180 according to the schedule in § 63.2180 and in subpart A of this part. Emission Limitations
 § 63.2140
  You must meet all of the emission limitations in Table 1 to this subpart. General Compliance Requirements
 § 63.2150
  (a) You must be in compliance with the emission limitations in Table 1 to this subpart at all times, except during periods of malfunction. (b) You must always operate and maintain your affected source, including monitoring equipment, according to the provisions in § 63.6(e)(1)(i). If the date upon which you must demonstrate initial compliance as specified in § 63.2160 falls after the compliance date specified for your affected source in § 63.2133, then you must maintain a log detailing the operation and maintenance of the continuous monitoring systems and the process and emissions control equipment during the period between those dates. (c) You must develop and implement a written malfunction plan. It will be as specified in § 63.6(e)(3), except that the requirements for startup, shutdown, and maintenance plans, records and reports apply only to malfunctions. Under this subpart, a period of malfunction is expressed in whole batches and not in portions of batches. Testing and Initial Compliance Requirements
 § 63.2160
  (a) For each emission limitation in Table 1 to this subpart for which compliance is demonstrated by monitoring fermenter exhaust, you must demonstrate initial compliance for the period ending on the last day of the month that is 12 calendar months (or 11 calendar months, if the compliance date for your source is the first day of the month) after the compliance date that is specified for your source in § 63.2133. (For example, if the compliance date is October 15, 2003, the first 12-month period for which you must demonstrate compliance would be October 15, 2003 through October 31, 2004.) (b) For each emission limitation in Table 1 to this subpart for which initial compliance is demonstrated by monitoring brew ethanol concentration and calculating volatile organic compound (VOC) concentration in the fermenter exhaust according to the procedures in § 63.2161, you must demonstrate initial compliance within 180 calendar days before the compliance date that is specified for your source in § 63.2133.
 § 63.2161
  (a) You must conduct each performance test in Table 2 to this subpart that applies to you. (b) Each performance test must be conducted according to the requirements in § 63.7(e)(1) and under the specific conditions that this subpart specifies in Table 2 to this subpart and in paragraphs (b)(1) through (4) of this section. (1) Conduct each performance test simultaneously with brew ethanol monitoring to establish a brew-to-exhaust correlation equation as specified in paragraph (f) of this section. (2) For each fermentation stage, conduct one run of the EPA Test Method 25A of 40 CFR part 60, appendix A, over the entire length of a batch. The three fermentation stages do not have to be from the same production run. (3) Do the test at a point in the exhaust-gas stream before you inject any dilution air, which is any air not needed to control fermentation. (4) Record the results of the test for each fermentation stage. (c) You may not conduct performance tests during periods of startup, shutdown, or malfunction, as specified in § 63.7(e)(1). (d) You must collect data to correlate the brew ethanol concentration measured by the continuous emission monitoring system (CEMS) to the VOC concentration in the fermenter exhaust according to paragraphs (d)(1) through (3) of this section. (1) You must collect a separate set of brew ethanol concentration data for each fed-batch fermentation stage while manufacturing the product that comprises the largest percentage (by mass) of average annual production. (2) Measure brew ethanol as specified in § 63.2164 simultaneously with conducting a performance test for VOC in fermenter exhaust as specified in paragraph (b) of this section. You must measure brew ethanol at least once during each successive 30-minute period over the entire period of the performance test for VOC in fermenter exhaust. (3) Keep a record of the brew ethanol concentration data for each fermentation stage over the period of EPA Test Method 25A of 40 CFR part 60, appendix A, performance test when the VOC concentration in the fermenter exhaust does not exceed the applicable emission limitation in Table 1 to this subpart. (e) For each set of data that you collected under paragraph (d) of this section, perform a linear regression of brew ethanol concentration (percent) on VOC fermenter exhaust concentration (parts per million by volume (ppmv) measured as propane). The correlation between the brew ethanol concentration as measured by the CEMS and the VOC fermenter exhaust concentration as measured by EPA Test Method 25A of 40 CFR part 60, appendix A, must be linear with a correlation coefficient of at least 0.90. (f) Calculate the VOC concentration in the fermenter exhaust using the brew ethanol concentration data collected under paragraph (d) of this section and according to Equation 1 of this section. BAVOC = BAE * CF + y  (Eq. 1) Where: BAVOC = batch-average concentration of VOC in fermenter exhaust (ppmv measured as propane), calculated for compliance demonstration BAE = batch-average concentration of brew ethanol in fermenter liquid (percent), measured by CEMS CF = constant established at performance test and representing the slope of the regression line y = constant established at performance test and representing the y-intercept of the regression line
 § 63.2162
  (a) For each emission limitation in Table 1 to this subpart for which compliance is demonstrated by monitoring brew ethanol concentration and calculating VOC concentration in the fermenter exhaust according to the procedures in § 63.2161, you must 
                            ( print page 27886)
                            conduct an EPA Test Method 25A of 40 CFR part 60, appendix A, performance test and establish a brew-to-exhaust correlation according to the procedures in Table 2 to this subpart and in § 63.2161, at least once every year. (b) The first subsequent performance test must be conducted no later than 365 calendar days after the initial performance test conducted according to § 63.2160. Each subsequent performance test must be conducted no later than 365 calendar days after the previous performance test. You must conduct a performance test for each 365 calendar day period for the lifetime of the affected source.
 § 63.2163
  (a) Each CEMS must be installed, operated, and maintained according to the applicable Performance Specification (PS) of 40 CFR part 60, appendix B. (b) You must conduct a performance evaluation of each CEMS according to the requirements in § 63.8, according to the applicable Performance Specification of 40 CFR part 60, appendix B, and according to paragraphs (b)(1) through (4) of this section. (1) If your CEMS monitor generates a single combined response value for VOC (examples of such detection principles are flame ionization, photoionization, and non-dispersive infrared absorption), but it is not a flame ionization analyzer, you must use PS 8 to show that your CEMS is operating properly. (i) Use EPA Test Method 25A of 40 CFR part 60, appendix A, to do the relative-accuracy test PS 8 requires. (ii) Calibrate the reference method with propane. (iii) Collect a 1-hour sample for each reference-method test. (2) If you continuously monitor VOC emissions using a flame ionization analyzer, then you must conduct the calibration drift test PS 8 requires, but you are not required to conduct the relative-accuracy test PS 8 requires. (3) If you continuously monitor VOC emissions using gas chromatography, you must use PS 9 of CFR part 60, appendix B, to show that your CEMS is operating properly. (4) You must complete the performance evaluation and submit the performance evaluation report before the compliance date that is specified for your source in § 63.2133. (c) Calibrate the CEMS with propane. (d) Set the CEMS span at not greater than 5 times the relevant emission limit, with 1.5 to 2.5 times the relevant emission limit being the range considered by us to be generally optimum. (e) You must monitor VOC concentration in fermenter exhaust at any point prior to dilution of the exhaust stream. (f) Each CEMS must complete a minimum of one cycle of operation (sampling, analyzing, and data recording) for each successive 30-minute period within each batch monitoring period. Except as specified in paragraph (g) of this section, you must have a minimum of two cycles of operation in a 1-hour period to have a valid hour of data. (g) The CEMS data must be reduced to arithmetic batch averages computed from two or more data points over each 1-hour period, except during periods when calibration, quality assurance, or maintenance activities pursuant to provisions of this part are being performed. During these periods, a valid hour of data shall consist of at least one data point representing a 30-minute period. (h) You must have valid CEMS data from at least 75 percent of the full hours over the entire batch monitoring period. (i) For each CEMS, record the results of each inspection, calibration, and validation check. (j) You must check the zero (low-level) and high-level calibration drifts for each CEMS in accordance with the applicable PS of 40 CFR part 60, appendix B. The zero (low-level) and high-level calibration drifts shall be adjusted, at a minimum, whenever the zero (low-level) drift exceeds 2 times the limits of the applicable PS. The calibration drift checks must be performed at least once daily except that they may be performed less frequently under the conditions of paragraphs (j)(1) through (3) of this section. (1) If a 24-hour calibration drift check for your CEMS is performed immediately prior to, or at the start of, a batch monitoring period of a duration exceeding 24 hours, you are not required to perform 24-hour-interval calibration drift checks during that batch monitoring period. (2) If the 24-hour calibration drift exceeds 2.5 percent of the span value (or more than 10 percent of the calibration gas value if your CEMS is a gas chromatograph (GC)) in fewer than 5 percent of the checks over a 1-month period, and the 24-hour calibration drift never exceeds 7.5 percent of the span value, then the frequency of calibration drift checks may be reduced to at least weekly (once every 7 days). (3) If, during two consecutive weekly checks, the weekly calibration drift exceeds 5 percent of the span value (or more than 20 percent of the calibration gas value, if your CEMS is a GC), then a frequency of at least 24-hour interval calibration checks must be resumed until the 24-hour calibration checks meet the test of paragraph (j)(2) of this section. (k) If your CEMS is out of control, you must take corrective action according to paragraphs (k)(1) through (3) of this section. (1) Your CEMS is out of control if the zero (low-level) or high-level calibration drift exceeds 2 times the limits of the applicable PS. (2) When the CEMS is out of control, take the necessary corrective action and repeat all necessary tests that indicate that the system is out of control. You must take corrective action and conduct retesting until the performance requirements are below the applicable limits. (3) During the batch monitoring periods in which the CEMS is out of control, recorded data shall not be used in data averages and calculations, or to meet any data availability requirement established under this subpart. The beginning of the out-of-control period is the beginning of the first batch monitoring period that follows the most recent calibration drift check during which the system was within allowable performance limits. The end of the out-of-control period is the end of the last batch monitoring period before you have completed corrective action and successfully demonstrated that the system is within the allowable limits. If your successful demonstration that the system is within the allowable limits occurs during a batch monitoring period, then the out-of-control period ends at the end of that batch monitoring period. If the CEMS is out of control for any part of a particular batch monitoring period, it is out of control for the whole batch monitoring period.
 § 63.2164
  (a) Each CEMS must be installed, operated, and maintained according to manufacturer's specifications and the plan for malfunctions that you must develop and use according to § 63.6(e). (b) Each CEMS must complete a minimum of one cycle of operation (sampling, analyzing, and data recording) for each successive 30-minute period within each batch monitoring period. Except as specified in paragraph (c) of this section, you must have a minimum of two cycles of operation in a 1-hour period to have a valid hour of data. 
                            ( print page 27887) (c) The CEMS data must be reduced to arithmetic batch averages computed from two or more data points over each 1-hour period, except during periods when calibration, quality assurance, or maintenance activities pursuant to provisions of this part are being performed. During these periods, a valid hour of data shall consist of at least one data point representing a 30-minute period. (d) You must have valid CEMS data from at least 75 percent of the full hours over the entire batch monitoring period. (e) Set the CEMS span to correspond to not greater than 5 times the relevant emission limit, with 1.5 to 2.5 times the relevant emission limit being the range considered by us to be generally optimum. Use the brew-to-exhaust correlation equation established under § 63.2161(f) to determine the span value for your CEMS that corresponds to the relevant emission limit. (f) For each CEMS, record the results of each inspection, calibration, and validation check. (g) The GC that you use to calibrate your CEMS must meet the requirements of paragraphs (g)(1) through (3) of this section. (1) Calibrate the GC at least daily, by analyzing standard solutions of ethanol in water (0.05 percent, 0.15 percent, and 0.3 percent). (2) For use in calibrating the GC, prepare the standard solutions of ethanol using the procedures listed in paragraphs (g)(2)(i) through (vi) of this section. (i) Starting with 100 percent ethanol, dry the ethanol by adding a small amount of anhydrous magnesium sulfate (granular) to 15-20 milliliters (ml) of ethanol. (ii) Place approximately 50 ml of water into a 100-ml volumetric flask and place the flask on a balance. Tare the balance. Weigh 2.3670 grams of the dry (anhydrous) ethanol into the volumetric flask. (iii) Add the 100-ml volumetric flask contents to a 1000-ml volumetric flask. Rinse the 100-ml volumetric flask with water into the 1000-ml flask. Bring the volume to 1000 ml with water. (iv) Place an aliquot into a sample bottle labeled “0.3% Ethanol.” (v) Fill a 50-ml volumetric flask from the contents of the 1000-ml flask. Add the contents of the 50-ml volumetric flask to a 100-ml volumetric flask and rinse the 50-ml flask into the 100-ml flask with water. Bring the volume to 100 ml with water. Place the contents into a sample bottle labeled “0.15% Ethanol.” (vi) With a 10-ml volumetric pipette, add two 10.0-ml volumes of water to a sample bottle labeled “0.05% Ethanol.” With a 10.0-ml volumetric pipette, pipette 10.0 ml of the 0.15 percent ethanol solution into the sample bottle labeled “0.05% Ethanol.” (3) For use in calibrating the GC, dispense samples of the standard solutions of ethanol in water in aliquots to appropriately labeled and dated glass sample bottles fitted with caps having a Teflon® seal. Refrigerated samples may be kept unopened for 1 month. Prepare new calibration standards of ethanol in water at least monthly. (h) Calibrate the CEMS according to paragraphs (h)(1) through (3) of this section. (1) To calibrate the CEMS, inject a brew sample into a calibrated GC and compare the simultaneous ethanol value given by the CEMS to that given by the GC. Use either the Porapak® Q, 80-100 mesh, 6′ × 
                            1/8
                            ′′, stainless steel packed column or the DB Wax, 0.53 mm × 30 m capillary column. (2) If a CEMS ethanol value differs by 20 percent or more from the corresponding GC ethanol value, determine the brew ethanol values throughout the rest of the batch monitoring period by injecting brew samples into the GC not less frequently than every 30 minutes. From the time at which the difference of 20 percent or more is detected until the batch monitoring period ends, the GC data will serve as the CEMS data. (3) Perform a calibration of the CEMS at least four times per batch.
 § 63.2165
  (a) You must demonstrate initial compliance with each emission limitation that applies to you according to Table 3 to this subpart. (b) You must submit the Notification of Compliance Status containing the results of the initial compliance demonstration according to the requirements in § 63.2180(e).
 § 63.2166
  (a) You must demonstrate initial compliance with each emission limitation that applies to you according to Table 3 to this subpart. (b) You must establish the brew-to-exhaust correlation for each fermentation stage according to § 63.2161(e). (c) You must submit the Notification of Compliance Status containing the results of the initial compliance demonstration according to the requirements in § 63.2180(e). Continuous Compliance Requirements
 § 63.2170
  (a) You must monitor and collect data according to this section. (b) Except for monitor malfunctions, associated repairs, and required quality assurance or control activities (including, as applicable, calibration checks and required zero and span adjustments), you must monitor continuously during each batch monitoring period. (c) You may not use data recorded during monitoring malfunctions, associated repairs, and required quality assurance or quality control activities in data averages and calculations used to report emission or operating levels, or to fulfill a minimum data availability requirement. You must use all the data collected during all other periods in assessing the operation of the control system.
 § 63.2171
  (a) You must demonstrate continuous compliance with each emission limitation in Table 1 to this subpart that applies to you according to methods specified in Table 4 to this subpart. (b) You must calculate the percentage of within-concentration batches (defined in § 63.2192) for each 12-month period according to paragraphs (b)(1) through (4) of this section. (1) Determine the percentage of batches over a 12-month calculation period that were in compliance with the applicable maximum concentration. The total number of batches in the calculation period is the sum of the numbers of batches of each fermentation stage for which emission limits apply. To calculate the 12-month percentage, do not include batches in production during periods of malfunction. In counting the number of batches in the 12-month calculation period, include those batches for which the batch monitoring period ended on or after 12 a.m. on the first day of the period and exclude those batches for which the batch monitoring period did not end on or before 11:59 p.m. on the last day of the period. (2) You must determine the 12-month percentage at the end of each calendar month. (3) The first 12-month calculation period begins on the compliance date that is specified for your source in § 63.2133 and ends on the last day of the month that includes the date 365 days after your compliance date, unless the 
                            ( print page 27888)
                            compliance date for your source is the first day of the month, in which case the first 12-month calculation period ends on the last day of the month that is 11 calendar months after the compliance date. (For example, if the compliance date for your source is October 15, 2003, the first 12-month calculation period would begin on October 15, 2003, and end on October 31, 2004. If the compliance date for your source is October 1, 2003, the first 12-month calculation period would begin on October 1, 2003, and end on September 30, 2004.) (4) The second 12-month calculation period and each subsequent 12-month calculation period begin on the first day of the month following the first full month of the previous 12-month averaging period and end on the last day of the month 11 calendar months later. (For example, if the compliance date for your source is October 15, 2003, the second calculation period would begin on December 1, 2003 and end on November 30, 2004.) (c) You must report each instance (that is, each 12-month calculation period) in which you did not meet each emission requirement in Table 4 to this subpart that applies to you. (Failure of a single batch to meet a concentration limit does not in and of itself constitute a failure to meet the emission limitation.) Each instance in which you failed to meet each applicable emission limitation is reported as part of the requirements in § 63.2181. (d) During periods of malfunction, you must operate in accordance with the malfunction plan. Notification, Reports, and Records
 § 63.2180
  (a) You must submit all of the notifications in §§ 63.7(b) and (c), 63.8(e), (f)(4) and (6), and 63.9(b) through (h) that apply to you by the dates specified. (b) If you start up your affected source before May 21, 2001, you are not subject to the initial notification requirements of § 63.9(b)(2). (c) If you are required to conduct a performance test as specified in Table 2 to this subpart, you must submit a notification of intent to conduct a performance test at least 60 calendar days before the performance test is scheduled to begin as required in § 63.7(b)(1). (d) If you are required to conduct a performance evaluation as specified in § 63.2163(b), you must submit a notification of the date of the performance evaluation at least 60 days prior to the date the performance evaluation is scheduled to begin as required in § 63.8(e)(2). (e) If you are required to conduct a performance test or other initial compliance demonstration as specified in Table 2 or 3 to this subpart, you must submit a Notification of Compliance Status according to § 63.9(h)(2)(ii) and according to paragraphs (e)(1) through (2) of this section. (1) For each initial compliance demonstration required in Table 3 to this subpart that does not include a performance test, you must submit the Notification of Compliance Status no later than July 31 or January 31, whichever date follows the end of the first 12 calendar months after the compliance date that is specified for your source in § 63.2133. If your initial compliance demonstration does not include a performance test, the first compliance report, described in § 63.2181(b)(1), serves as the Notice of Compliance Status. (2) For each initial compliance demonstration required in Table 2 or 3 to this subpart that includes a performance test conducted according to the requirements in Table 2, you must submit the Notification of Compliance Status, including the performance test results, before the close of business on the 60th calendar day following the completion of the performance test according to § 63.10(d)(2).
 § 63.2181
  (a) You must submit each report in Table 5 to this subpart that applies to you. (b) Unless the Administrator has approved a different schedule for submission of reports under § 63.10(a), you must submit each report by the date in Table 5 to this subpart and according to paragraphs (b)(1) through (5) of this section. (1) The first compliance report must cover the period beginning on the compliance date that is specified for your affected source in § 63.2133 and ending on either June 30 or December 31 (use whichever date is the first date following the end of the first 12 calendar months after the compliance date that is specified for your source in § 63.2133). The first compliance report must include the percentage of within-concentration batches, as described in § 63.2171(b), for the first 12-month calculation period described in § 63.2171(b)(3). It must also include a percentage for each subsequent 12-month calculation period, as described in § 63.2171(b)(4), ending on a calendar month that falls within the first compliance period. (For example, if the compliance date for your source is October 15, 2003, the first compliance report would cover the period from October 15, 2003 to December 31, 2004. It would contain percentages for the 12-month periods ending October 31, 2004; November 30, 2004; and December 31, 2004.) (2) The first compliance report must be postmarked or delivered no later than July 31 or January 31, whichever date follows the end of the first 12 calendar months after the compliance date that is specified for your affected source in § 63.2133. (3) Each subsequent compliance report must cover the semiannual reporting period from January 1 through June 30 or the semiannual reporting period from July 1 through December 31. Each subsequent compliance report must include the percentage of within-concentration batches for each 12-month calculation period ending on a calendar month that falls within the reporting period. (For example, if the compliance date for your source is October 15, 2003, the second compliance report would cover the period from January 1, 2005 through June 30, 2005. It would contain percentages for the 12-month periods ending January 31, 2005; February 28, 2005; March 31, 2005; April 30, 2005; May 31, 2005; and June 30, 2005.) (4) Each subsequent compliance report must be postmarked or delivered no later than July 31 or January 31, whichever date is the first date following the end of the semiannual reporting period. (5) For each affected source that is subject to permitting regulations pursuant to 40 CFR part 70 or part 71, and if the permitting authority has established dates for submitting semiannual reports pursuant to 40 CFR 70.6(a)(3)(a)(iii)(A) or 40 CFR 71.6(a)(3)(a)(iii)(A), you may submit the first and subsequent compliance reports according to the dates the permitting authority has established instead of according to the dates in paragraphs (b)(1) through (4) of this section. (c) The compliance report must contain the information listed in paragraphs (c)(1) through (5) of this section. (1) Company name and address. (2) Statement by a responsible official with that official's name, title, and signature, certifying the accuracy of the content of the report. (3) Date of report and beginning and ending dates of the reporting period. (4) Percentage of batches that are within-concentration batches for each 12-month period ending on a calendar 
                            ( print page 27889)
                            month that falls within the reporting period. (5) If you had a malfunction during the reporting period and you took actions consistent with your malfunction plan, the compliance report must include the information in § 63.10(d)(5)(i) for each malfunction.
 § 63.2182
  (a) You must keep the records listed in paragraphs (a)(1) through (4) of this section. These include: (1) A copy of each notification and report that you submitted to comply with this subpart, including all documentation supporting any Notification of Compliance Status and compliance report that you submitted, according to the requirements in § 63.10(b)(2)(xiv). (2) The records in § 63.6(e)(3)(iii) through (v) related to malfunction; (3) Records of performance tests and performance evaluations as required in § 63.10(b)(2)(viii); and (4) Records of results of brew-to-exhaust correlation tests specified in § 63.2161. (b) For each CEMS, you must keep the records listed in paragraphs (b)(1) through (9) of this section. These include: (1) Records described in § 63.10(b)(2)(vi); (2) All required measurements needed to demonstrate compliance with a relevant standard (including, but not limited to, 30-minute averages of CEMS data, raw performance testing measurements, and raw performance evaluation measurements, that support data that the source is required to report); (3) Records described in § 63.10(b)(2)(viii) through (xi). The CEMS system must allow the amount of excess zero (low-level) and high-level calibration drift measured at the interval checks to be quantified and recorded; (4) All required CEMS measurements (including monitoring data recorded during unavoidable CEMS breakdowns and out-of-control periods); (5) Identification of each batch during which the CEMS was inoperative, except for zero (low-level) and high-level checks; (6) Identification of each batch during which the CEMS was out of control, as defined in § 63.2163(k); (7) Previous (i.e., superseded) versions of the performance evaluation plan as required in § 63.8(d)(3); (8) Request for alternatives to relative accuracy test for CEMS as required in § 63.8(f)(6)(i); and (9) Records of each batch for which the batch-average VOC concentration exceeded the applicable maximum VOC concentration in Table 1 to this subpart and whether the batch was in production during a period of malfunction or during another period. (c) You must keep the records required in Table 4 to this subpart to show continuous compliance with each emission limitation that applies to you. (d) You must also keep the records listed in paragraphs (d)(1) through (3) of this section for each batch in your affected source. (1) Unique batch identification number. (2) Fermentation stage for which you are using the fermenter. (3) Unique CEMS equipment identification number.
 § 63.2183
  (a) Your records must be in a form suitable and readily available for expeditious review, according to § 63.10(b)(1). (b) As specified in § 63.10(b)(1), you must keep each record for 5 years following the date of each occurrence, measurement, maintenance, corrective action, report, or record. (c) You must keep each record on site for at least 2 years after the date of each occurrence, measurement, maintenance, corrective action, report, or record, according to § 63.10(b)(1). You can keep the records offsite for the remaining 3 years. Other Requirements and Information
 § 63.2190
  Table 6 to this subpart shows which parts of the General Provisions in §§ 63.1 through 63.13 apply to you.
 § 63.2191
  (a) This subpart can be implemented and enforced by us, the U.S. EPA, or a delegated authority such as your State, local, or tribal agency. If the U.S. EPA Administrator has delegated authority to your State, local, or tribal agency, then that agency has the authority to implement and enforce this subpart. You should contact your U.S. EPA Regional Office to find out if this subpart is delegated to your State, local, or tribal agency. (b) In delegating implementation and enforcement authority of this subpart to a State, local, or tribal agency under 40 CFR part 63, subpart E, the authorities contained in paragraph (c) of this section are retained by the Administrator of the U.S. EPA and are not transferred to the State, local, or tribal agency. (c) The authorities that will not be delegated to State, local, or tribal agencies are as listed in paragraphs (c)(1) through (4) of this section. (1) Approval of alternatives to the non-opacity emission limitations in § 63.2140 under § 63.6(g). (2) Approval of major alternatives to test methods under § 63.7(e)(2)(ii) and (f) and as defined in § 63.90. (3) Approval of major alternatives to monitoring under § 63.8(f) and as defined in § 63.90. (4) Approval of major alternatives to recordkeeping and reporting under § 63.10(f) and as defined in § 63.90.
 § 63.2192
  Terms used in this subpart are defined in the Clean Air Act, in 40 CFR 63.2, the General Provisions of this part, and in this section as follows: *Batch*
                             means a single fermentation cycle in a single fermentation vessel (fermenter). *Batch monitoring period*
                             means the period that begins at the later of either the start of aeration or the addition of yeast to the fermenter; the period ends at the earlier of either the end of aeration or the point at which the yeast has begun being emptied from the fermenter. *Brew*
                             means the mixture of yeast and additives in the fermenter. *Brew ethanol*
                             means the ethanol in fermenter liquid. *Brew ethanol monitor*
                             means the monitoring system that you use to measure brew ethanol to demonstrate compliance with this subpart. The monitoring system includes a resistance element used as an ethanol sensor, with the measured resistance proportional to the concentration of ethanol in the brew. *Brew-to-exhaust correlation*
                             means the correlation between the concentration of ethanol in the brew and the concentration of VOC in the fermenter exhaust. This correlation is specific to each fed-batch fermentation stage and is established while manufacturing the product that comprises the largest percentage (by mass) of average annual production. *Emission limitation*
                             means any emission limit or operating limit. *Fed-batch*
                             means the yeast is fed carbohydrates and additives during fermentation in the vessel. In contrast, carbohydrates and additives are added to “set-batch” fermenters only at the start of the batch. *1-hour period*
                             means any 60-minute period commencing on the minute at which the batch monitoring period begins. 
                            ( print page 27890) *Product*
                             means the yeast resulting from the final stage in a production run. Products are distinguished by yeast species, strain, and variety. *Responsible official*
                             means responsible official as defined in 40 CFR 70.2. *Specialty yeast*
                             includes but is not limited to yeast produced for use in wine, champagne, whiskey, and beer. *Within-concentration batch*
                             means a batch for which the average VOC concentration is not higher than the maximum concentration that is allowed as part of the applicable emission limitation. Tables As stated in § 63.2140, you must comply with the emission limitations in the following table: Table 1 to Subpart CCCC.—Emission Limitations
For each fed-batch fermenter producing yeast in the following fermentation stage . . .
You must meet the following emission limitation . . .Last stage (Trade); or Second-to-last stage (First Generation); or Third-to-last stage (Stock)
a. For at least 98 percent of all batches (sum of batches from last, second-to-last, and third-to-last stages) in each 12-month calculation period described in § 63.2171(b), the VOC concentration in the fermenter exhaust does not exceed the applicable maximum concentration (100 ppmv for last stage, 200 ppmv for second-to-last stage, or 300 ppmv for third-to-last stage), measured as propane, and averaged over the duration of a batch. 
                                     b. The emission limitation does not apply during the production of specialty yeast.
 As stated in § 63.2161, if you demonstrate compliance by monitoring brew ethanol, you must comply with the requirements for performance tests in the following table: Table 2 to Subpart CCCC.—requirements for performance tests
[Brew Ethanol Monitoring Only]
For each fed-batch fermenter for which compliance is determined by monitoring brew ethanol concentration and calculating VOC concentration in the fermenter exhaust according to the procedures in § 63.2161, you must . . .
Using . . .
According to the following requirements . . .1. Measure VOC as propane
Method 25A*, or an alternative validated by EPA Method in the 301* and approved by the Administrator
You must measure the VOC concentration in the fermenter exhaust at any point prior to dilution of the exhaust stream.2. Select the sampling port's location and the number of traverse points
Method 1*3. Measure volumetric flow rate.
Method 2*4. Perform gas analysis to determine the dry molecular weight of the stack gas
Method 3*5. Determine moisture content of the stack gas
Method 4**EPA Test Methods found in appendix A of 40 CFR part 60.
 As stated in § 63.2165 (if you monitor fermenter exhaust) and § 63.2166 (if you monitor brew ethanol), you must comply with the requirements to demonstrate initial compliance with the applicable emission limitations in the following table: Table 3 to Subpart CCCC.—Initial Compliance With Emission Limitations
For . . .
For the following emission limitation . . .
You have demonstrated initial compliance if . . .1. Each fed-batch fermenter producing yeast in a fermentation stage (last Trade), second-to-last (First Generation), or third-to-last (Stock)) for which compliance is determined by monitoring VOC concentration in the fermenter exhaust
The VOC concentration in the fermenter exhaust, averaged over the duration of the batch, does not exceed the applicable maximum concentration (100 ppmv for last stage, 200 ppmv for second-to-last stage, or 300 ppmv for third-to-last stage), measured as propane.
a. You reduce the CEMS data batch averages according to § 63.2163(g). 
                                 b. The average VOC concentration in the fermenter exhaust for at least 98 percent of the batches (sum of batches from last, second-to-last, and third-to-last stages) during the initial compliance period described in § 63.2160(a) does not exceed the applicable maximum concentration.2. Each fed-batch fermenter producing yeast in a fermentation stage (last (Trade), second-to-last (First Generation), or third-to-last (Stock)) for which compliance is determined by monitoring brew ethanol concentration and calculating VOC concentration in the fermenter exhaust according to the procedures in § 63.2161
The VOC concentration in the fermenter exhaust, averaged over the duration of the batch, does not exceed the applicable maximum concentration (100 ppmv for last stage, 2000 ppmv for second-to-last stage, or 300 ppmv for third-to-last stage), measured as propane
a. The VOC fermenter exhaust concentration over the period of the Method 25A* performance test does not exceed the applicable maximum concentration. 
                                 b. You have a record of the brew-to-exhaust correlation during the Method 25A* performance test during which the VOC fermenter exhaust concentration did not exceed the applicable maximum concentration.* EPA Test Method in appendix A of 40 CFR part 60.
 
 
 As stated in § 63.2171, you must comply with the requirements to demonstrate continuous compliance with the applicable emission limitations in the following table: Table 4 to Subpart CCCC.—Continuous Compliance With Emission Limitations
For . . .
For the following emission limitation . . .
You must demonstrate continuous compliance by . . .1. Each fed-batch fermenter producing yeast in a fermentation stage (last (Trade), second-to-last (First Generation), or third-to-last (Stock)) for which compliance is determined by monitoring VOC concentration in the fermenter exhaust
For at least 98 percent of all batches (sum of batches from last, second-to-last, and third-to-last stages) in each 12-month calculation period described in § 63.2171(b), the VOC concentration in the fermenter exhaust, averaged over the duration of the batch, does not exceed the applicable maximum concentration (100 ppmv for last stage, 200 ppmv for second-to-last stage, or 300 ppmv for third-to-last stage), measured as propane
a. Collecting the monitoring data according to § 63.2163(f). 
                                 b. Reducing the data according to § 63.2163(g).  
                                 c. For at least 98 percent of the batches (sum of batches from last, second-to-last, and third-to-last stages) for each 12-month period ending within a semiannual reporting period described in § 63.2181(b)(3), the batch average VOC concentration in the fermenter exhaust does not exceed the applicable maximum concentration.2. Each fed-batch fermenter producing yeast in a fermentation stage (last (Trade), second-to-last (First Generation), or third-to-last (Stock)) for which compliance is determined by monitoring brew ethanol concentration and calculating VOC concentration in the fermenter exhaust according to the procedures in § 63.2161
.For at least 98 percent of all batches (sum of batches from last, second-to-last, and third-to-last stages) in each 12-month calculation period described in § 63.2171(b), the VOC concentration in the fermenter exhaust, averaged over the duration of the batch, does not exceed the applicable maximum concentration (100 ppmvc for last stage, 200 ppmv for second-to-last stage, or 300 ppmv for third-to-last stage), measured as propane
a. Collecting the monitoring data according to § 63.2164(b). 
                                 b. Reducing the data according to § 63.2164(c).  
                                 c. For at least 98 percent of the batches (sum of batches from last, second-to-last, and third-to-last stages) for each 12-month period ending within a semiannual reporting period described in § 63.2181(b)(3), the batch average VOC concentration in the fermenter exhaust does not exceed the applicable maximum concentration.
 As stated in § 63.2181, you must submit a compliance report that contains the information in § 63.2181(c) as well as the information in the following table; you must also submit malfunction reports according to the requirements in the following table: Table 5 to Subpart CCCC.—Requirements for Reports
You must submit a(n)
The report must contain . . .
You must submit the report . . .1. Compliance report
a. Your calculated percentage of within-concentration batches, as described in § 63.2171(b), for 12-month calculation periods ending on each calendar month that falls within the reporting period
Semiannually according to the requirements in § 63.2181(b).b. If you had a malfunction during the reporting period and you took actions consistent with your malfunction plan, the compliance report must include the information in § 63.10(d)(5)(i)
Semiannually according to the requirements in § 63.2181(b).2. Immediate malfunction report if you had a malfunction during the reporting period that is not consistent with your malfunction plan
a. Actions taken for the event
By fax or telephone within 2 working days after starting actions inconsistent with the plan.b. The information in § 63.10(d)(5)(ii)
By letter within 7 working days after the end of the event unless you have made alternative arrangements with the permitting authority (§ 63.10(d)(5)(ii)).
 As stated in § 63.2190, you must comply with the applicable General Provisions requirements according to the following table: Table 6 to Subpart CCCC.—Applicability of General Provisions to Subpart CCCC
Citation
Subject
Applicable to subpart CCCC?§ 63.1
Applicability
Yes.§ 63.2
Definitions
Yes.§ 63.3
Units and Abbreviations
Yes.§ 63.4
Prohibited Activities and Circumvention
Yes.§ 63.5
Construction and Reconstruction
Yes.§ 63.6
Compliance With Standards and Maintenance Requirements
1. For § 63.6(e) and (f), requirements for startup, shutdown, and malfunctions apply only to malfunctions.
                                 2. § 63.6(h) does not apply. 
                                 3. Otherwise, all apply.( print page 27892)§ 63.7
Performance Testing Requirements
1. § 63.7(a)(1)-(2) and (e)(3) do not apply, instead specified in this subpart. 
                                 2. Otherwise, all apply.§ 63.8
Monitoring Requirements
1. § 63.8(a)(2) is modified by § 63.2163. 
                                 2. § 63.8(a)(4) does not apply.  
                                 3. For § 63.8(c)(1), requirements for startup, shutdown, and malfunctions apply only to malfunctions, and no report pursuant to § 63.10(d)(5)(i) is required.  
                                 4. For § 63.8(d), requirements for startup, shutdown, and malfunctions apply only to malfunctions.  
                                 5. § 63.8(c)(4)(i), (c)(5), (e)(5)(ii), and (g)(5), do not apply.  
                                 6. § 63.8(c)(4)(ii), (c)(6)-(8), (e)(4), and (g)(1)-(4) do not apply, instead specified in this subpart.  
                                 7. Otherwise, all apply.§ 63.9
Notification Requirements
1. § 63.9(b)(2) does not apply because rule omits requirements for initial notification for sources that start up prior to May 21, 2001 
                                 2. § 63.9(f) does not apply.  
                                 3. Otherwise, all apply.§ 63.10
Recordkeeping and Reporting Requirements
1. For § 63.10(b)(2)(i)-(v), (c)(9)-(15), and (d)(5), requirements for startup, shutdown, and malfunctions apply only to malfunctions. 
                                 2. § 63.10(b)(2)(vii) and (c)(1)-(6) do not apply, instead specified in this subpart.  
                                 3. § 63.10(c)(7)-(8), (d)(3), (e)(2)(ii)-(4), (e)(3)-(4) do not apply.  
                                 4. Otherwise, all apply.§ 63.11
Flares
No.§ 63.12
Delegation
Yes.§ 63.13
Addresses
Yes.§ 63.14
Incorporation by Reference
Yes.§ 63.15
Availability of Information
Yes.


[FR Doc. 01-12041 Filed 5-18-01; 8:45 am] BILLING CODE 6560-50-P