Title 40: Protection of Environment
PART 63 -- NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES (CONTINUED)

Subpart MMMMM -- National Emission Standards for Hazardous Air Pollutants: Flexible Polyurethane Foam Fabrication Operations

Contents
What This Subpart Covers
§63.8780   What is the purpose of this subpart?
§63.8782   Am I subject to this subpart?
§63.8784   What parts of my plant does this subpart cover?
§63.8786   When do I have to comply with this subpart?
Emission Limitations
§63.8790   What emission limitations must I meet?
General Compliance Requirements
§63.8794   What are my general requirements for complying with this subpart?
Testing and Initial Compliance Requirements
§63.8798   By what date must I conduct performance tests or other initial compliance demonstrations?
§63.8800   What performance tests and other procedures must I use to demonstrate compliance with the emission limit for flame lamination?
§63.8802   What methods must I use to demonstrate compliance with the emission limitation for loop slitter adhesive use?
§63.8806   How do I demonstrate initial compliance with the emission limitations?
Continuous Compliance Requirements
§63.8810   How do I monitor and collect data to demonstrate continuous compliance?
§63.8812   How do I demonstrate continuous compliance with the emission limitations?
Notification, Reports, and Records
§63.8816   What notifications must I submit and when?
§63.8818   What reports must I submit and when?
§63.8820   What records must I keep?
§63.8822   In what form and how long must I keep my records?
Other Requirements and Information
§63.8826   What parts of the General Provisions apply to me?
§63.8828   Who implements and enforces this subpart?
§63.8830   What definitions apply to this subpart?
Table 1 to Subpart MMMMM of Part 63 -- Emission Limits
Table 2 to Subpart MMMMM of Part 63 -- Operating Limits for Existing, New, or Reconstructed Flame Lamination Affected Sources
Table 3 to Subpart MMMMM of Part 63 -- Performance Test Requirements for Existing, New, or Reconstructed Flame Lamination Affected Sources
Table 4 to Subpart MMMMM of Part 63 -- Initial Compliance With Emission Limits
Table 5 to Subpart MMMMM of Part 63 -- Continuous Compliance With Emission Limits and Operating Limits
Table 6 to Subpart MMMMM of Part 63 -- Requirements for Reports
Table 7 to Subpart MMMMM of Part 63 -- Applicability of General Provisions to Subpart MMMMM
Table 8 to Subpart MMMMM of Part 63 -- List of Hazardous Air Pollutants That Must Be Counted Toward Total HAP Content if Present at 0.1 Percent or More by Weight

Source: 68 FR 18070, Apr. 14, 2003, unless otherwise noted.
What This Subpart Covers
§63.8780   What is the purpose of this subpart?
This subpart establishes national emission standards for hazardous air pollutants (NESHAP) emitted from flexible polyurethane foam fabrication operations. This subpart also establishes requirements to demonstrate initial and continuous compliance with the emission standards.
§63.8782   Am I subject to this subpart?
(a) You are subject to this subpart if you own or operate a flexible polyurethane foam fabrication plant site that operates a flame lamination affected source, as defined at §63.8784(b)(2), and that is located at, or is part of a major emission source of hazardous air pollutants (HAP) or that operates a loop slitter affected source, as defined at §63.8784(b)(1), that meets the criteria in paragraphs (a)(1) and (2) of this section.
(1) The loop slitter affected source uses one or more HAP-based adhesives at any time on or after April 14, 2003.
(2) The loop slitter affected source is located at or is part of a major source of HAP.
(b) A flexible polyurethane foam fabrication plant site is a plant site where pieces of flexible polyurethane foam are bonded together or to other substrates using HAP-based adhesives or flame lamination.
(c) A major source of HAP is a plant site that emits or has the potential to emit any single HAP at a rate of 10 tons or more per year or any combination of HAP at a rate of 25 tons or more per year.
(d) This subpart does not apply to the following processes in paragraphs (d)(1) and (2) of this section:
(1) Processes that produce flexible polyurethane or rebond foam as defined in subpart III of this part.
(2) A research and development facility, as defined in section 112(c)(7) of the Clean Air Act (CAA).
§63.8784   What parts of my plant does this subpart cover?
(a) This subpart applies to each existing, new, or reconstructed affected source at facilities engaged in flexible polyurethane foam fabrication.
(b) The affected sources are defined in this section in paragraphs (b)(1) and (2) of this section.
(1) The loop slitter adhesive use affected source is the collection of all loop slitters and associated adhesive application equipment used to apply HAP-based adhesives to bond foam to foam at a flexible polyurethane foam fabrication plant site.
(2) The flame lamination affected source is the collection of all flame lamination lines associated with the flame lamination of foam to any substrate at a flexible polyurethane foam fabrication plant site.
(c)(1) A new affected source is one that commences construction after August 8, 2001 and meets the applicability criteria of §63.8782 at the time construction commences.
(2) If you add one or more flame lamination lines at a plant site where flame lamination lines already exist, the added line(s) shall be a new affected source and meet new source requirements if the added line(s) are at a flexible polyurethane foam fabrication plant site that has the potential to emit 10 tons per year or more of any HAP or 25 tons or more per year of any combination of HAP.
(d) A reconstructed affected source is one that commences reconstruction after August 8, 2001 and meets the criteria for reconstruction as defined in §63.2.
(e) An affected source
 is existing if it commenced construction or reconstruction on or before August 8, 2001.
[68 FR 18070, Apr. 14, 2003, as amended at 71 FR 20470, Apr. 20, 2006]
§63.8786   When do I have to comply with this subpart?
(a) If you have a new or reconstructed affected source, you must comply with this subpart according to paragraphs (a)(1) and (2) of this section.
(1) If you start up your new or reconstructed affected source before April 14, 2003, then you must comply with the emission standards for new or reconstructed sources in this subpart no later than April 14, 2003.
(2) If you start up your new or reconstructed affected source on or after April 14, 2003, then you must comply with the emission standards for new or reconstructed sources in this subpart upon startup of your affected source.
(b) If you have an existing affected source, you must comply with this subpart according to paragraphs (b)(1) and (b)(2) of this section, as applicable.
(1) If you have an existing loop slitter affected source, you must comply with the emission standards for existing sources no later than April 14, 2004.
(2) If you have an existing flame lamination affected source, you must comply with the emission standards for existing sources no later than [INSERT DATE 180 DAYS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER].
(c) If you have an area source that increases its emissions or its potential to emit such that it becomes a major source of HAP and an affected source subject to this subpart, the provisions in paragraphs (c)(1) and (2) of this section apply.
(1) A new affected source as specified at §63.8784(c) or a reconstructed affected source as specified at §63.8784(d) must be in compliance with this subpart upon startup.
(2) An existing affected source as specified at §63.8784(e) must be in compliance with this subpart no later than 1 year after the date on which the area source became a major source.
(d) You must meet the notification requirements in §63.8816 according to the schedule in §63.8816 and in subpart A of this part. Some of the notifications must be submitted before you are required to comply with the emission standards in this subpart.
(e) If you have a loop slitter affected source, you must have data on hand beginning on the compliance date specified in paragraph (b) of this section as necessary to demonstrate that your adhesives are not HAP-based. The types of data necessary are described in §§63.8802 and 63.8810.
(f) You must comply with the electronic reporting requirements according to paragraphs (f)(1) and (f)(2) of this section.
(1) You must comply with the performance test and CMS performance evaluation requirements of §63.8818(j) on or before [INSERT DATE 180 DAYS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER].
(2) You must comply with the compliance report requirements of §63.8818(k) on or before [INSERT DATE 180 DAYS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER] or once the report template for this subpart has been available on the CEDRI website for 1 year, whichever date is later.
Emission Limitations
§63.8790   What emission limitations must I meet?
(a) You must meet each emission limit in Table 1 to this subpart that applies to you.
(b) You must meet each operating limit in Table 2 to this subpart that applies to you.
General Compliance Requirements
§63.8794   What are my general requirements for complying with this subpart?
(a) For each loop slitter adhesive use affected source, you must be in compliance with the requirements in this subpart at all times.
(b) For each flame lamination affected source, you must be in compliance with the requirements in this subpart at all times.
(c) At all times, you must operate and maintain any affected source, including associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. The general duty to minimize emissions does not require you to make any further efforts to reduce emissions if levels required by the
applicable standard have been achieved. Determination of whether a source is operating in compliance with operation and maintenance requirements will be based on information available to the Administrator which may include, but is not limited to, monitoring results, review of operation and maintenance procedures, review of operation and maintenance records, and inspection of the source.
(d) For flame lamination affected sources in §63.8786 using a control device to comply with the emission limitations in Table 1 to this subpart, you must maintain a log detailing the operation and maintenance of the process and emissions control equipment during the period between the compliance date specified for your flame lamination affected source in §63.8786 and the date upon which continuous compliance monitoring systems required by §63.8810(c) have been installed and verified and any applicable operating limits have been set.

(e) [Reserved]
(f) For each monitoring system required by §63.8810(c) for flame lamination sources, you must develop and submit for approval a site-specific monitoring plan that addresses the requirements in paragraphs (f)(1) through (3) of this section.
(1) Installation of the continuous monitoring system (CMS) sampling probe or other interface at a measurement location relative to each affected process unit such that the measurement is representative of control of the exhaust emissions (e.g., on or downstream of the last control device);
(2) Performance and equipment specifications for the sample interface, the pollutant concentration or parametric signal analyzer, and the data collection and reduction system; and
(3) Performance evaluation procedures and acceptance criteria (e.g., calibrations).
(g) In your site-specific monitoring plan, you must also address the ongoing procedures specified in paragraphs (g)(1) through (3) of this section.
(1) Ongoing operation and maintenance procedures in accordance with the general requirements of §§63.8(c)(1), (3), (4)(ii), (7), and (8), and 63.8804;
(2) Ongoing data quality assurance procedures in accordance with the general requirements of §63.8(d); and
(3) Ongoing recordkeeping and reporting procedures in accordance with the general requirements of §63.10(c), (e)(1), and (e)(2)(i).
[68 FR 18070, Apr. 14, 2003, as amended at 71 FR 20470, Apr. 20, 2006]
Testing and Initial Compliance Requirements
§63.8798   By what date must I conduct performance tests or other initial compliance demonstrations?
(a) For each loop slitter affected source, you must conduct the initial compliance demonstration by the compliance date that is specified for your source in §63.8786.
(b) For each flame lamination affected source, you must conduct performance tests by the compliance date that is specified for your source in §63.8786 and according to the provisions in §63.7(a)(2).
(c) You must conduct subsequent performance tests to demonstrate compliance with the flame lamination emissions limitations in Table 1 to this subpart no less frequently than every 5 years from the date of the last performance test.
§63.8800   What performance tests and other procedures must I use to demonstrate compliance with the emission limit for flame lamination?
(a) You must conduct each performance test in Table 3 to this subpart that applies to you.
(b) Each performance test must be conducted according to the requirements in paragraph (c) of this section and under the specific conditions in Table 3 to this subpart.
(c) You must conduct each performance test under conditions representative of normal operations. You may not conduct performance tests during periods of SSM. The owner or operator must record the process information that is necessary to document operating conditions during the test and include in such record an explanation to support that such conditions represent normal operation. Upon request, the owner or operator shall make available to the Administrator such records as may be necessary to determine the conditions of performance tests.
(d) You must conduct at least three separate test runs for each performance test required in this section, as specified in §63.7(e)(3). Each test run must last at least 1 hour.
(e) For new and reconstructed affected sources, you must determine the percent reduction of HAP emissions during the performance test according to paragraphs (e)(1) through (3) of this section.
(1) If you use chlorinated fire retardant foams, determine the percent reduction of HCl to represent HAP emissions from the source. If you do not use chlorinated fire retardant foams, determine the percent reduction of HCN to represent HAP emissions from the source.
(2) Calculate the concentration of HAP at the control device inlet and at the control device outlet using the procedures in the specified test method.
(3) Compare the calculated HAP concentration at the control device inlet to the calculated HAP concentration at the control device outlet to determine the percent reduction over the period of the performance test, using Equation 1 of this section:

View or download PDF
Where:
R = Efficiency of control device, percent.
Einlet,i = HAP concentration of control device inlet stream for test run i, mg/dscm.
Eoutlet,i = HAP concentration of control device outlet stream for test run i, mg/dscm.
n = Number of runs conducted for the performance test.
.
(f) For existing affected sources, you must determine the HCl emissions rate according to paragraphs (f)(1) through (3) of this section.
(1) Calculate the concentration of HCl in the vent outlet to the atmosphere or at the control device outlet, if a control device is used, using the procedures in the specified test method.
(2) Determine the vent outlet gas stream volumetric flow rate or if a control device is used, the control device outlet gas stream volumetric flow rate, using the procedures in the specified test method.
(3) Calculate the HCl emission rate for the period of the performance test using Equation 2 of this section:
EHCl= C x AOF	Eq.2
Where:
EHCl = Emission rate of HCl, lbs/hr.
C= average HCl concentration of vent or control device outlet stream for all test runs, lb/dscft.
AOF = average outlet volumetric flow rate of gas stream, dry basis, dscft/hr.
(g) You must also meet the requirements in paragraphs (g)(1) and (2) of this section.
(1) Conduct the performance tests using foams that are representative of foams typically used at your flame lamination affected source. If you use foams containing chlorinated fire retardants, you must conduct the performance tests using these foams.
(2) Establish all applicable operating limits that correspond to the control system efficiency as described in Table 3 to this subpart.
§63.8802   What methods must I use to demonstrate compliance with the emission limitation for loop slitter adhesive use?
(a) Determine the HAP content for each material used. To determine the HAP content for each material used in your foam fabrication operations, you must use one of the options in paragraphs (a)(1) through (3) of this section. If you use the option in paragraph (a)(3) of this section, you are subject to the provisions of paragraph (a)(4) of this section.
(1) Method 311 (appendix A to 40 CFR part 63). You may use Method 311 for determining the mass fraction of HAP. Use the procedures specified in paragraphs (a)(1)(i) and (ii) of this section when determining HAP content by Method 311.
(i) Include in the HAP total each HAP in Table 8 of this subpart that is measured at 0.1 percent by weight or more and any other HAP that is measured at 1.0 percent by weight or more. Express the weight fraction of each HAP you measure as a value truncated to four places after the decimal point (for example, 0.1234).
(ii) Calculate the total HAP content in the test material by adding up the individual HAP contents and truncating the result to three places after the decimal point (for example, 0.123).
(2) Alternative method. You may use an alternative test method for determining mass fraction of HAP if you obtain prior approval by the Administrator. You must follow the procedure in §63.7(f) to submit an alternative test method for approval.
(3) Information from the supplier or manufacturer of the material. You may rely on information other than that generated by the test methods specified in paragraphs (a)(1) and (2) of this section to determine the mass fraction of HAP according to paragraphs (a)(3)(i) and (ii) of this section. This information may include, but is not limited to, a material safety data sheet (MSDS), a certified product data sheet (CPDS), or a manufacturer's hazardous air pollutant data sheet.
(i) Include in the HAP total each HAP in Table 8 of this subpart that is present at 0.1 percent by weight or more and any other HAP that is present at 1.0 percent by weight or more.
(ii) If the HAP content is provided by the material supplier or manufacturer as a range, then you must use the upper limit of the range for determining compliance.
(4) Verification of supplier or manufacturer information. Although you are not required to perform testing to verify the information obtained according to paragraph (a)(3) of this section, the Administrator may require a separate measurement of the total HAP content using the methods specified in paragraph (a)(1) or (2) of this section. If this measurement exceeds the total HAP content provided by the material supplier or manufacturer, then you must use the measured HAP content to determine compliance.
(b) [Reserved]
§63.8806   How do I demonstrate initial compliance with the emission limitations?
(a) You must demonstrate initial compliance with each emission limit that applies to you according to Table 4 to this subpart.
(b) You must establish each site-specific operating limit in Table 2 to this subpart that applies to you according to the requirements in §63.8800 and Table 3 to this subpart.
(c) You must submit the Notification of Compliance Status containing the results of the initial compliance demonstration according to the requirements in §63.8816(e) through (h).
Continuous Compliance Requirements
§63.8810   How do I monitor and collect data to demonstrate continuous compliance?
(a) If you own or operate a loop slitter adhesive use affected source, you must meet the requirements in paragraphs (a)(1) and (2) of this section.
(1) Maintain a list of each adhesive and the manufacturer or supplier of each.
(2) Maintain a record of EPA Method 311 (appendix A to 40 CFR part 63), approved alternative method, or other reasonable means of HAP content determinations indicating the mass percent of each HAP for each adhesive.
(b) If you own or operate a flame lamination affected source, you must meet the requirements in paragraphs (b)(1) through (3) of this section if you use a scrubber, or paragraph (b)(4) of this section if you use any other control device.
(1) Keep records of the daily average scrubber inlet liquid flow rate.
(2) Keep records of the daily average scrubber effluent pH.
(3) If you use a venturi scrubber, keep records of daily average pressure drop across the venturi.
(4) Keep records of operating parameter values for each operating parameter that applies to you.
(c) If you own or operate a control device to meet the emissions limitations for a flame lamination affected source, you must meet the requirements in paragraphs (c)(1) through (4) of this section.
(1) Except for periods of monitoring-associated repairs and required quality assurance or control activities (including, as applicable, calibration checks and required zero and span adjustments), you must monitor continuously (or collect data at all required intervals) at all times that the affected source is operating.
(2) In data average calculations and calculations used to report emission or operating levels, you may not use data recorded during monitoring malfunctions, associated repairs, or recorded during required quality assurance or control activities. Nor may such data be used in fulfilling any applicable minimum data availability requirement. You must use all the data collected during all other periods in assessing the operation of the control device and associated control system.
(3) You must conduct a performance evaluation of each CMS in accordance with your site-specific monitoring plan.
(4) You must operate and maintain the CMS in continuous operation according to the site-specific monitoring plan.
§63.8812   How do I demonstrate continuous compliance with the emission limitations?
(a) You must demonstrate continuous compliance with each emission limit and operating limit in Tables 1 and 2 to this subpart that applies to you according to the methods specified in Table 5 to this subpart.
(b) You must report each instance in which you did not meet each emission limit and each operating limit in Tables 1 and 2 to this subpart that applies to you. These instances are deviations from the operating limits in this subpart. These deviations must be reported according to the requirements in §63.8818.
(c) [Reserved]

(d) [Reserved]
(e) You must meet the following requirements if you are complying with the adhesive use ban for loop slitter adhesive use described in §63.8790(a).
(1) If, after you submit the Notification of Compliance Status, you use an adhesive for which you have not previously verified percent HAP mass using the methods in §63.8802, you must verify that each adhesive used in the affected source meets the emission limit, using any of the methods in §63.8802.
(2) You must update the list of all the adhesives used at the affected source.
(3) With the compliance report for the reporting period during which you used the new adhesive, you must submit the updated list of all adhesives and a statement certifying that, as purchased, each adhesive used at the affected source during the reporting period met the emission limit in Table 1 to this subpart.
[68 FR 18070, Apr. 14, 2003, as amended at 71 FR 20470, Apr. 20, 2006]
Notification, Reports, and Records
§63.8816   What notifications must I submit and when?
(a) You must submit all of the notifications in §§63.7(b) and (c), 63.8(f), and 63.9(b) through (h) that apply to you.
(b) If you own or operate an existing loop slitter or flame lamination affected source, submit an initial notification no later than 120 days after April 14, 2003, or no later than 120 days after the source becomes subject to this subpart, whichever is later.
(c) If you own or operate a new or reconstructed loop slitter or flame lamination affected source, submit the application for construction or reconstruction required by §63.9(b)(1)(iii) in lieu of the initial notification.
(d) If you own or operate a flame lamination affected source, 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).
(e) If you own or operate a loop slitter affected source, submit a Notification of Compliance Status according to §63.9(h)(2)(ii) within 60 days of the compliance date specified in §63.8786.
(f) If you own or operate a flame lamination affected source, submit a Notification of Compliance Status according to §63.9(h)(2)(ii) that includes the results of the performance test conducted according to the requirements in Table 3 to this subpart. You must submit the notification before the close of business on the 60th calendar day following the completion of the performance test according to §63.10(d)(2).
(g) For each flame lamination affected source, the Notification of Compliance Status must also include the information in paragraphs (g)(1) and (2) that applies to you.
(1) The operating parameter value averaged over the full period of the performance test (for example, average pH).
(2) The operating parameter range within which HAP emissions are reduced to the level corresponding to meeting the applicable emission limits in Table 1 to this subpart.
(h) For each loop slitter adhesive use affected source, the Notification of Compliance Status must also include the information listed in paragraphs (h)(1) and (2) of this section.
(1) A list of each adhesive used at the affected source, its HAP content (percent by weight), and the manufacturer or supplier of each.
(2) A statement certifying that each adhesive that was used at the affected source during the reporting period met the emission limit in Table 1 to this subpart.
§63.8818   What reports must I submit and when?
(a) You must submit each report in Table 6 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 compliance report for flame lamination affected sources semiannually according to paragraphs (b)(1) through (4) 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 §63.8786 and ending on June 30 or December 31, whichever date is the first date following the end of the first calendar half after the compliance date that is specified for your source in §63.8786.
(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 calendar half after the compliance date that is specified for your affected source in §63.8786.
(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.
(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.
(c) For each loop slitter adhesive use affected source, you may submit annual compliance reports in place of semiannual reports.
(d) For each affected source that is subject to permitting regulations pursuant to 40 CFR part 70 or 40 CFR part 71, and if the permitting authority has established dates for submitting semiannual reports pursuant to 40 CFR 70.6(a)(3)(iii)(A) or 40 CFR 71.6(a)(3)(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.
(e) The compliance report must contain the information in paragraphs (e)(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 truth, accuracy and completeness of the content of the report.
(3) Date of report and beginning and ending dates of the reporting period.
(4) If there are no deviations from any emission limitations (emission limit or operating limit) that applies to you, a statement that there were no deviations from the emission limitations during the reporting period.
(5) For each deviation from an emission limitation that occurs, the compliance report must contain the information specified in paragraphs (e)(5)(i) through (iii) of this section.

(i) The total operating time of each affected source during the reporting period.
(ii) Information on the number, duration, and cause of deviations (including unknown cause, if applicable), as applicable, and the corrective action taken.
(iii) Information on the number, duration, and cause for continuous parameter monitoring system (CPMS) downtime incidents, if applicable, other than downtime associated with zero and span and other daily calibration checks.
(f) The compliance report for flame lamination affected sources required by §63.8810(c) to conduct continuous monitoring must also contain the following information in paragraphs (f)(1) and (2) of this section.

(1) If there were no periods during which the CPMS was out-of-control in accordance with the monitoring plan, a statement that there were no periods during which the CPMS was out-of-control during the reporting period.
(2) If there were periods during which the CPMS was out-of-control in accordance with the monitoring plan, the date, time, and duration of each out-of-control period.
(g) The compliance report for a loop slitter adhesive use affected source must also contain the following information in paragraphs (g)(1) and (2) of this section.
(1) For each annual reporting period during which you use an adhesive that was not included in the list submitted with the Notification of Compliance Status in §63.8816(h)(1), an updated list of all adhesives used at the affected source.
(2) A statement certifying that each adhesive that was used at the affected source during the reporting period met the emission limit in Table 1 to this subpart.
(h) Each affected source that has obtained a title V operating permit pursuant to 40 CFR part 70 or 40 CFR part 71 must report all deviations as defined in this subpart in the semiannual monitoring report required by 40 CFR 70.6(a)(3)(iii)(A) or 40 CFR 71.6(a)(3)(iii)(A). If an affected source submits a compliance report pursuant to Table 6 to this subpart along with, or as part of, the semiannual monitoring report required by 40 CFR 70.6(a)(3)(iii)(A) or 40 CFR 71.6(a)(3)(iii)(A), and the compliance report includes all required information concerning deviations from any emission limitation (including any operating limit) in this subpart, submission of the compliance report shall be deemed to satisfy any obligation to report the same deviations in the semiannual monitoring report. However, submission of a compliance report shall not otherwise affect any obligation the affected source may have to report deviations from permit requirements to the permit authority.

(i) [Reserved]
(j) Performance Test and CMS Performance Evaluation Reports. Beginning on [INSERT DATE 180 DAYS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER], within 60 days after the date of completing each performance test or CMS performance evaluation (as defined in §63.2) required by this subpart, the owner or operator must submit the results of the performance test or CMS performance evaluation following the procedures specified in paragraphs (j)(1) through (3) of this section.
(1) Data collected using test methods supported by the EPA's Electronic Reporting Tool (ERT) as listed on the EPA's ERT website (https://www.epa.gov/electronic-reporting-air-emissions/electronic-reporting-tool-ert) at the time of the test. Submit the results of the performance test or the performance evaluation of CMS measuring relative accuracy test audit (RATA) pollutants to the EPA via the Compliance and Emissions Data Reporting Interface (CEDRI), which can be accessed through the EPA's Central Data Exchange (CDX) (https://cdx.epa.gov/). The data must be submitted in a file format generated through the use of the EPA's ERT. Alternatively, you may submit an electronic file consistent with the extensible markup language (XML) schema listed on the EPA's ERT website.
(2) Data collected using test methods that are not supported by the EPA's ERT as listed on the EPA's ERT website at the time of the test. The results of the performance test or the performance evaluation of CMS measuring RATA pollutants by methods that are not supported by the ERT, must be included as an attachment in the ERT or an alternate electronic file consistent with the XML schema listed on the EPA's ERT website. Submit the ERT generated package or alternative file to the EPA via CEDRI.
(3) Confidential business information (CBI). Do not use CEDRI to submit information you claim as CBI. Anything submitted using CEDRI cannot later be claimed CBI. Although we do not expect persons to assert a claim of CBI, if you wish to assert a CBI claim for some of the information submitted under paragraph (a)(1) or (2) of this section, you must submit a complete file, including information claimed to be CBI, to the EPA. The file must be generated using the EPA's ERT or an alternate electronic file consistent with the XML schema listed on the EPA's ERT website. Submit the file on a compact disc, flash drive, or other commonly used electronic storage medium and clearly mark the medium as CBI. Mail the electronic medium to U.S. EPA/OAQPS/CORE CBI Office, Attention: Group Leader, Measurement Policy Group, MD C404-02, 4930 Old Page Rd., Durham, NC  27703. The same file with the CBI omitted must be submitted to the EPA via the EPA's CDX as described in paragraphs (a)(1) and (2) of this section. All CBI claims must be asserted at the time of submission. Furthermore, under CAA section 114(c), emissions data is not entitled to confidential treatment, and the EPA is required to make emissions data available to the public. Thus, emissions data will not be protected as CBI and will be made publicly available.
(k) Submitting reports electronically. On and after the date specified in §63.8786(f)(2), you must submit reports to the EPA via CEDRI, which can be accessed through the EPA's CDX (https://cdx.epa.gov/). The EPA will make all the information submitted through CEDRI available to the public without further notice to you. Do not use CEDRI to submit information you claim as confidential business information (CBI). Anything submitted using CEDRI cannot later be claimed CBI. You must use the appropriate electronic report template on the CEDRI website (https://www.epa.gov/electronic-reporting-air-emissions/cedri) for this subpart. The date report templates become available will be listed on the CEDRI website. Unless the Administrator or delegated state agency or other authority has approved a different schedule for submission of reports, the report must be submitted by the deadline specified in this subpart, regardless of the method in which the report is submitted. Although we do not expect persons to assert a claim of CBI, if you wish to assert a CBI claim, submit a complete report, including information claimed to be CBI, to the EPA. The report must be generated using the appropriate form on the CEDRI website. Submit the file on a compact disc, flash drive, or other commonly used electronic storage medium and clearly mark the medium as CBI. Mail the electronic medium to U.S. EPA/OAQPS/CORE CBI Office, Attention: Group Leader, Measurement Policy Group, MD C404-02, 4930 Old Page Rd., Durham, NC 27703. The same file with the CBI omitted must be submitted to the EPA via the EPA's CDX as described earlier in this paragraph (k). All CBI claims must be asserted at the time of submission. Furthermore, under CAA section 114(c), emissions data is not entitled to confidential treatment, and the EPA is required to make emissions data available to the public. Thus, emissions data will not be protected as CBI and will be made publicly available.
(l) Claims of EPA system outage. When you are required to electronically submit a report through CEDRI in the EPA's CDX, you may assert a claim of EPA system outage for failure to timely comply with the reporting requirement. To assert a claim of EPA system outage, you must meet the requirements outlined in paragraphs (l)(1) through (7) of this section.
(1) You must have been or will be precluded from accessing CEDRI and submitting a required report within the time prescribed due to an outage of either the EPA's CEDRI or CDX systems.
(2) The outage must have occurred within the period of time beginning five business days prior to the date that the submission is due.
(3) The outage may be planned or unplanned.
(4) You must submit notification to the Administrator in writing as soon as possible following the date you first knew, or through due diligence should have known, that the event may cause or has caused a delay in reporting.
(5) You must provide to the Administrator a written description identifying:
(i) The date(s) and time(s) when CDX or CEDRI was accessed and the system was unavailable;
(ii) A rationale for attributing the delay in reporting beyond the regulatory deadline to EPA system outage;
(iii) Measures taken or to be taken to minimize the delay in reporting; and
(iv) The date by which you propose to report, or if you have already met the reporting requirement at the time of the notification, the date you reported.
(6) The decision to accept the claim of EPA system outage and allow an extension to the reporting deadline is solely within the discretion of the Administrator.
(7) In any circumstance, the report must be submitted electronically as soon as possible after the outage is resolved.
(m) Claims of force majeure. When you are required to electronically submit a report through CEDRI in the EPA's CDX, you may assert a claim of force majeure for failure to timely comply with the reporting requirement. To assert a claim of force majeure, you must meet the requirements outlined in paragraphs (m)(1) through (5) of this section.
(1) You may submit a claim if a force majeure event is about to occur, occurs, or has occurred or there are lingering effects from such an event within the period of time beginning five business days prior to the date the submission is due. For the purposes of this section, a force majeure event is defined as an event that will be or has been caused by circumstances beyond the control of the affected facility, its contractors, or any entity controlled by the affected facility that prevents you from complying with the requirement to submit a report electronically within the time period prescribed. Examples of such events are acts of nature (e.g., hurricanes, earthquakes, or floods), acts of war or terrorism, or equipment failure or safety hazard beyond the control of the affected facility (e.g., large scale power outage).
(2) You must submit notification to the Administrator in writing as soon as possible following the date you first knew, or through due diligence should have known, that the event may cause or has caused a delay in reporting.
(3) You must provide to the Administrator:
(i) A written description of the force majeure event;
(ii) A rationale for attributing the delay in reporting beyond the regulatory deadline to the force majeure event;
(iii) Measures taken or to be taken to minimize the delay in reporting; and
(iv) The date by which you propose to report, or if you have already met the reporting requirement at the time of the notification, the date you reported.
(4) The decision to accept the claim of force majeure and allow an extension to the reporting deadline is solely within the discretion of the Administrator.
(5) In any circumstance, the reporting must occur as soon as possible after the force majeure event occurs.
§63.8820   What records must I keep?
(a) You must keep a copy of each notification and report that you submit to comply with this subpart, including all documentation supporting any Initial Notification or Notification of Compliance Status that you submitted, according to the requirements in §63.10(b)(2)(xiv).
(b) For each flame lamination affected source, you must also keep the following records specified in paragraphs (b)(1) through (3) of this section.

(1) Records of performance tests, as required in §63.10(b)(2)(viii).
(2) Records of the operating parameter values required in §63.8810(b).
(3) The records specified in paragraphs (b)(3)(i) through (iii) of this section .
(i) The number of deviations. For each deviation, record the date, time, cause and duration of the deviation.

(ii) For each deviation, record and retain a list of the affected sources or equipment, an estimate of the quantity of each regulated pollutant emitted over any emission limit and a description of the method used to estimate the emissions.
(iii) Record actions taken to minimize emissions in accordance with §63.8794(c), and any corrective actions taken to return the affected unit to its normal or usual manner of operation.
(c) For each loop slitter adhesive use affected source, you must keep the following records specified in paragraphs (c)(1) and (2) of this section.
(1) A list of each adhesive and the manufacturer or supplier of each.
(2) A record of EPA Method 311 (appendix A to 40 CFR part 63), approved alternative method, or other reasonable means of determining the mass percent of total HAP for each adhesive used at the affected source.
§63.8822   In what form and how long must I keep my records?
(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
§63.8826   What parts of the General Provisions apply to me?
Table 7 to this subpart shows which sections of the General Provisions in §§63.1 through 63.15 apply to you.
§63.8828   Who implements and enforces this subpart?
(a) This subpart can be implemented and enforced by us, the U.S. Environmental Protection Agency (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, in addition to the U.S. EPA, has the authority to implement and enforce this subpart. You should contact your U.S. EPA Regional Office to find out if implementation and enforcement of 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 U.S. EPA and are not transferred to the State, local, or tribal agency.
(c) The authorities in paragraphs (c)(1) through (4) that cannot be delegated to State, local, or tribal agencies are as follows:
(1) Approval of alternatives to requirements in §§63.8780, 63.8782, 63.8784, 63.8786, and 63.8790.
(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.
§63.8830   What definitions apply to this subpart?
Terms used in this subpart are defined in the CAA, in 40 CFR 63.2, and in this section as follows:
Adhesive means any chemical substance that is applied for the purpose of bonding foam to foam, foam to fabric, or foam to any other substrate, other than by mechanical means. Products used on humans and animals, adhesive tape, contact paper, or any other product with an adhesive incorporated onto it in an inert substrate shall not be considered adhesives under this subpart.
Deviation means any instance in which an affected source subject to this subpart, or an owner or operator of such a source:
(1) Fails to meet any requirement or obligation established by this subpart, including but not limited to any emission limitation (including any operating limit); or
(2) Fails to meet any term or condition that is adopted to implement an applicable requirement in this subpart and that is included in the operating permit for any affected source required to obtain such a permit; or
(3) Fails to meet any emission limitation (including any operating limit) in this subpart, regardless of whether or not such failure is permitted by this subpart.
Emission limitation means any emission limit or operating limit.
Flame lamination means the process of bonding flexible foam to one or more layers of material by heating the foam surface with an open flame.
Flame lamination line means the flame laminator and associated rollers.
HAP-based adhesive means an adhesive containing 1.0 percent by weight or more of any individual or combination HAP listed in Table 8 to this subpart or 1.0 percent by weight or more of any other individual HAP, according to information from the supplier or manufacturer of the material, EPA Method 311 (appendix A to 40 CFR part 63) or another approved alternative.
Loop slitter means a machine used to create thin sheets of foam from the large blocks of foam or "buns" created at a slabstock flexible polyurethane foam production plant.
Research and development process means a laboratory or pilot plant operation whose primary purpose is to conduct research and development into new processes and products where the operations are under the close supervision of technically trained personnel, and which is not engaged in the manufacture of products for commercial sale, except in a de minimis manner.
Responsible official means responsible official as defined in 40 CFR 70.2.
Table 1 to Subpart MMMMM of Part 63 -- Emission Limits
As stated in §63.8790(a), you must comply with the emission limits in the following table:
                               For .  .  .
                             You must .  .  .
1. Each existing, new, or reconstructed loop slitter adhesive use affected source
Not use any HAP-based adhesives.
2. Each new or reconstructed flame lamination affected source
Reduce HAP emissions by 90 percent.
3. Each existing flame lamination affected source
Emit no more than 1.45 pounds per hour of HCl per flame lamination line.
Table 2 to Subpart MMMMM of Part 63 -- Operating Limits for Existing, New, or Reconstructed Flame Lamination Affected Sources
As stated in §63.8790(b), you must comply with the applicable operating limits in the following table:
                             For each .  .  .
                             You must .  .  .
1. Scrubber
a. Maintain the daily average scrubber inlet liquid flow rate above the minimum value established during the performance test.

b. Maintain the daily average scrubber effluent pH within the operating range value established during the performance test.

c. If you use a venturi scrubber, maintain the daily average pressure drop across the venturi within the operating range value established during the performance test.
2. Other type of control device to which flame lamination emissions are ducted
Maintain your operating parameter(s) within the ranges established during the performance test and according to your monitoring plan.
Table 3 to Subpart MMMMM of Part 63 -- Performance Test Requirements for Existing, New, or Reconstructed Flame Lamination Affected Sources
As stated in §63.8800, you must comply with the requirements for performance tests for flame lamination affected sources in the following table using the requirements in rows 1 through 5 of the table if you are measuring HCl and using a scrubber, row 6 for new or reconstructed sources measuring HCN and using a scrubber, and row 7 if you are using any other control device. For existing sources not using a control device, you must comply with row 8 and also rows 1 through 4 of the table.
For each existing, new, or reconstructed flame lamination affected source, you must .  .  .
                              Using .  .  .
             According to the following requirements .  .  .
1. Select sampling port's location and the number of traverse ports
Method 1 or 1A in appendix A to part 60 of this chapter
Sampling sites must be located at the inlet and outlet of the scrubber and prior to any releases to the atmosphere.
2. Determine velocity
Method 2, 2A, 2C, 2D, 2F, or 2G in appendix A to part 60 of this chapter.

3. Determine gas molecular weight
Not applicable
Assume a molecular weight of 29 (after moisture correction) for calculation purposes.
4. Measure moisture content of the stack gas
Method 4 in appendix A to part 60 of this chapter.

5. Measure HCl concentration
Method 26A in appendix A to part 60 of this chapter
i.  For new or reconstructed sources, determine the HCl reduction efficiency of the control device using Method 26A
 and the procedures specified in §63.8800(e).
ii. For existing sources, determine the HCl emission rate using Method 26A and the procedures specified in §63.8800(f).
iii. Collect scrubber liquid flow rate, scrubber effluent pH, and pressure drop (pressure drop data only required for venturi scrubbers) every 15 minutes during the entire duration of each 1-hour test run, and determine the average scrubber liquid flow rate, scrubber effluent pH, and pressure drop (pressure drop data only required for venturi scrubbers) over the period of the performance test by computing the average of all of the 15-minute readings.
6. Measure HCN concentration
A method approved by the Administrator
i. Conduct the performance test according to the site-specific test plan submitted according to §63.7(c)(2)(i). Measure total HCN emissions and determine the reduction efficiency of the control device. Any performance test which measures HCN concentrations must be submitted for the administrator's approval prior to testing. You must use EPA Method 301 (40 CFR part 63, Appendix A) to validate your method.
ii. Collect scrubber liquid flow rate, scrubber effluent pH, and pressure drop (pressure drop data only required for venturi scrubbers) every 15 minutes during the entire duration of each 1-hour test run, and determine the average scrubber liquid flow rate, scrubber effluent pH, and pressure drop (pressure drop data only required for venturi scrubbers) over the period of the performance test by computing the average of all of the 15-minute readings.
7. If you use any control device other than a scrubber, establish operating parameter limits with which you will demonstrate continuous compliance with the emission limit that applies to the source
EPA-approved methods and data from the continuous parameter monitoring system
i. Conduct the performance test according to the site-specific test plan submitted according to §63.7(c)(2)(i).
ii. For new or reconstructed sources, determine the HCl or HCN reduction efficiency of the control device using the EPA-approved method and the procedures specified in §63.8800(e).
iii. For existing sources, determine the HCl emission rate using the EPA-approved method and the procedures specified in §63.8800(f).
iv. Collect operating parameter data as specified in the site-specific test plan.
8. Measure HCl concentration
Method 26A in appendix A to part 60 of this chapter
Determine the HCl emission rate using the appropriate test methods and the procedures specified in §63.8800(f).

Table 4 to Subpart MMMMM of Part 63 -- Initial Compliance With Emission Limits
As stated in §63.8806, you must comply with the requirements to demonstrate initial compliance with the applicable emission limits in the following table:
                               For .  .  .
                 For the following emission limit .  .  .
           You have demonstrated initial compliance if .  .  .
1. Each new, reconstructed, or existing loop slitter adhesive use affected source
Eliminate use of HAP-based adhesives
You do not use HAP-based adhesives.
2. Each new or reconstructed flame lamination affected source using a scrubber
Reduce HAP emissions by 90 percent
The average HAP emissions, measured over the period of the performance test(s), are reduced by 90 percent.
3. Each new or reconstructed flame lamination affected source using any other control device emissions by
Reduce HAP emissions by 90 percent
The average HAP emissions, measured over the period of the performance test(s), are reduced by 90 percent.
4. Each existing flame lamination affected source
Emit no more than 1.45 pounds per hour of HCl per flame lamination line
The average HCl emissions, measured over the period of the performance test(s) do not exceed 1.45 pounds per hour per flame lamination line.
Table 5 to Subpart MMMMM of Part 63 -- Continuous Compliance With Emission Limits and Operating Limits
As stated in §63.8812(a), you must comply with the requirements to demonstrate continuous compliance with the applicable emission limits or operating limits in the following table:
                               For .  .  .
      For the following emission limits or operating limits .  .  .
          You must demonstrate continuous compliance by .  .  .
1. Each new, reconstructed, or existing loop slitter affected source
Eliminate use of HAP-based adhesives
Not using HAP-based adhesives.
2. Each existing, new, or reconstructed flame lamination affected source using a scrubber
a. Maintain the daily average scrubber inlet liquid flow rate above the minimum value established during the performance
b. Maintain the daily average scrubber effluent pH within the operating range established during the performance test
c. Maintain the daily average pressure drop across the venturi within the operating range established during the performance test. If you use another type of scrubber (e.g., packed bed or spray tower scrubber), monitoring pressure drop is not required
i. Collecting the scrubber inlet liquid flow rate and effluent pH monitoring data according to §63.8804(a) through (c).
ii. Reducing the data to 1-hour and daily block averages according to the requirements in §63.8804(a).
iii. Maintaining each daily average scrubber inlet liquid flow rate above the minimum value established during the performance test.
iv. Maintaining the daily average scrubber effluent pH within the operating range established during the performance test.
v. If you use a venturi scrubber, maintaining the daily average pressure drop across the venturi within the operating range established during the performance test.
3. Each existing, new, or reconstructed flame lamination affected source using any other control device
a. Maintain the daily average operating parameters above the minimum value established during the performance test, or within the range established during the performance test, as applicable
i. Collected the operating parameter data according to the site-specific test plan.
ii. Reducing the data to one-hour averages according to the requirements in §63.8804(a).
iii. Maintaining the daily average during the rate above the minimum value established during the performance test, or within the range established during the performance test, as applicable.
Table 6 to Subpart MMMMM of Part 63 -- Requirements for Reports
You must submit a compliance report that includes the information in §63.8818(e) through (g) as well as the information in the following table, as applicable. Rows 1 and 3 of the following table apply to loop slitter affected sources. Rows 1 through 4 apply to flame lamination affected sources.
                                If .  .  .
         Then you must submit a report or statement that .  .  .
1. There are no deviations from any emission limitations that apply to you
There were no deviations from the emission limitations during the reporting period.
2. There were no periods during which the operating parameter monitoring systems were out-of-control in accordance with the monitoring plan
There were no periods during which the CPMS were out-of-control during the reporting period.
3. There was a deviation from any emission limitation during the reporting period
Contains the information in §63.8818(e)(5).
4. There were periods during which the operating parameter monitoring systems were out-of-control in information in accordance with the monitoring plan
Contains the information in §63.8818(f)(2).

Table 7 to Subpart MMMMM of Part 63 -- Applicability of General Provisions to Subpart MMMMM
As stated in §63.8826, you must comply with the applicable General Provisions requirements according to the following table:
                                   Citation
                                 Requirement
                           Applies to subpart MMMMM
                                 Explanation
§63.1
Initial applicability determination; applicability after standard established; permit requirements; extensions; notifications
Yes

§63.2
Definitions
Yes
Additional definitions are found in §63.8830.
§63.3
Units and abbreviations
Yes

§63.4
Prohibited activities; compliance date; circumvention, severability
Yes

§63.5
Construction/reconstruction applicability; applications; approvals
Yes

§63.6(a)
Compliance with standards and maintenance requirements-applicability
Yes

§63.6(b)(1)-(4)
Compliance dates for new or reconstructed sources
Yes
§63.8786 specifies compliance dates.
§63.6(b)(5)
Notification if commenced construction or reconstruction after proposal
Yes

§63.6(b)(6)
[Reserved]
Yes

§63.6(b)(7)
Compliance dates for new or reconstructed area sources that become major
Yes
§63.8786 specifies compliance dates.
§63.6(c)(1)-(2)
Compliance dates for existing sources
Yes
§63.8786 specifies compliance dates.
§63.6(c)(3)-(4)
[Reserved]
Yes

§63.6(c)(5)
Compliance dates for existing area sources that become major
Yes
§63.8786 specifies compliance dates.
§63.6(d)
[Reserved]
Yes

§63.6(e)(1)(i)
General duty to minimize emissions
No
§63.8794(c) specifies general duty requirements.
§63.6(e)(1)(ii)
Requirement to correct malfunctions as soon as possible
No

§63.6(e)(1)(iii)
Enforceability of requirements independent of other regulations
Yes

§63.6(e)(2)
[Reserved]
Yes

§63.6(e)(3)
SSM plans
No

§63.6(f)(1)
Compliance except during SSM
No

§63.6(f)(2)-(3)
Methods for determining compliance
Yes

§63.6(g)
Use of an alternative nonopacity emission standard
Yes

§63.6(h)
Compliance with opacity/visible emission standards
No
Subpart MMMMM does not specify opacity or visible emission standards.
§63.6(i)
Extension of compliance with emission standards
Yes

§63.6(j)
Presidential compliance exemption
Yes

§63.7(a)(1)-(2)
Performance test dates
Yes
Except for loop slitter affected sources as specified in §63.8798(a).
§63.7(a)(3)
Administrator's section 114 authority to require a performance test
Yes

§63.7(b)
Notification of performance test and rescheduling
Yes

§63.7(c)
Quality assurance program and site-specific test plans
Yes

§63.7(d)
Performance testing facilities
Yes

§63.7(e)(1)
Conditions for conducting performance tests
No
Requirements for performance test conditions are found in §63.8800(b) and (c).
§63.7(e)(2)-(3)
Performance test data reduction and number of test runs
Yes

§63.7(f)
Use of an alternative test method
Yes

§63.7(g)
Performance test data analysis, recordkeeping, and reporting
Yes

§63.7(h)
Waiver of performance tests
Yes

§63.8(a)(1)-(2)
Applicability of monitoring requirements
Yes
Unless otherwise specified, all of §63.8 applies only to new or reconstructed flame lamination sources. Additional monitoring requirements for these sources are found in §§63.8794(f) and (g) and 63.8804.
§63.8(a)(3)
[Reserved]
Yes

§63.8(a)(4)
Monitoring with flares
No
Subpart MMMMM does not refer directly or indirectly to §63.11.
§63.8(b)
Conduct of monitoring and procedures when there are multiple effluents and multiple monitoring systems
Yes

§63.8(c)(1)-(3)
Continuous monitoring system (CMS) operation and maintenance
No
CMS requirements are found in §63.8794(f) and (g).
§63.8(c)(4)
Continuous monitoring system requirements during breakdown, out-of-control, repair, maintenance, and high-level calibration drifts
Yes
Applies as modified by §63.8794(g).
§63.8(c)(5)
Continuous opacity monitoring system (COMS) minimum procedures
No
Subpart MMMMM does not have opacity or visible emission standards.
§63.8(c)(6)
Zero and high level calibration checks
Yes
Applies as modified by §63.8794(f).
§63.8(c)(7)-(8)
Out-of-control periods, including reporting
Yes

§63.8(d)-(e)
Quality control program and CMS performance evaluation
No
CMS requirements are found in §63.8794(f) and (g).
§63.8(f)(1)-(5)
Use of an alternative monitoring method
Yes

§63.8(f)(6)
Alternative to relative accuracy test
No
Only applies to sources that use continuous emissions monitoring systems (CEMS).
§63.8(g)
Data reduction
Yes
Applies as modified by §63.8794(g).
§63.9(a)
Notification requirements -- applicability
Yes

§63.9(b)
Initial notifications
Yes
Except §63.8816(c) requires new or reconstructed affected sources to submit the application for construction or reconstruction required by §63.9(b)(1)(iii) in lieu of the initial notification.
§63.9(c)
Request for compliance extension
Yes

§63.9(d)
Notification that a new source is subject to special compliance requirements
Yes

§63.9(e)
Notification of performance test
Yes

§63.9(f)
Notification of visible emissions/opacity test
No
Subpart MMMMM does not have opacity or visible emission standards.
§63.9(g)(1)
Additional CMS notifications -- date of CMS performance evaluation
Yes

§63.9(g)(2)
Use of COMS data
No
Subpart MMMMM does not require the use of COMS.
§63.9(g)(3)
Alternative to relative accuracy testing
No
Applies only to sources with CEMS.
§63.9(h)
Notification of compliance status
Yes

§63.9(i)
Adjustment of submittal deadlines
Yes

§63.9(j)
Change in previous information
Yes

§63.9(k)
Electronic reporting procedures
Yes
Only as specified in §63.9(j).
§63.10(a)
Recordkeeping/reporting applicability
Yes

§63.10(b)(1)
General recordkeeping requirements
Yes
§§63.8820 and 63.8822 specify additional recordkeeping requirements.
§63.10(b)(2)(i) and (ii)
Records related to SSM periods and CMS
No
 See §63.8820 for recordkeeping of (1) date, time, and duration; (2) listing of affected source or equipment, and an estimate of the quantity of each regulated pollutant emitted over the standard; and (3) actions to minimize emissions and correct the failure.
§63.10(b)(2)(iii)
Records of maintenance on air pollution control equipment.
Yes

§63.10(b)(2)(iv) and (v)
Records related to SSM
No

§63.10(b)(2)(vi)  -  (xi)
Records of CMS and other compliance records
Yes

§63.10(b)(2)(xii)
Records when under waiver
Yes

§63.10(b)(2)(xiii)
Records when using alternative to relative accuracy test
No
Applies only to sources with CEMS.
§63.10(b)(2)(xiv)
All documentation supporting initial notification and notification of compliance status
Yes

§63.10(b)(3)
Recordkeeping requirements for applicability determinations
Yes

§63.10(c)
Additional recordkeeping requirements for sources with CMS
Yes
Applies as modified by §63.8794(g).
§63.10(d)(1)
General reporting requirements
Yes
§63.8818 specifies additional reporting requirements.
§63.10(d)(2)
Performance test results
Yes

§63.10(d)(3)
Opacity or visible emissions observations
No
Subpart MMMMM does not specify opacity or visible emission standards.
§63.10(d)(4)
Progress reports for sources with compliance extensions
Yes

§63.10(d)(5)
SSM reports
No

§63.10(e)(1)
Additional CMS reports -- general
Yes
Applies as modified by §63.8794(g).
§63.10(e)(2)(i)
Results of CMS performance evaluations
Yes
Applies as modified by §63.8794(g).
§63.10(e)(2)
Results of continuous opacity monitoring systems performance evaluations
No
Subpart MMMMM does require the use of COMS.
§63.10(e)(3)
Excess emissions/CMS performance reports
Yes
Only applies to new or reconstructed flame lamination affected sources.
§63.10(e)(4)
Continuous opacity monitoring system data reports
No
Subpart MMMMM does not require the use of COMS.
§63.10(f)
Recordkeeping/reporting waiver
Yes

§63.11.
Control device requirements -- applicability
No
Facilities subject to subpart MMMMM do not use flares as control devices.
§63.12
State authority and delegations
Yes
§63.8828 lists those sections of subparts MMMMM and A that are not delegated.
§63.13
Addresses
Yes

§63.14
Incorporation by reference
Yes
Subpart MMMMM does not incorporate any material by reference.
§63.15
Availability of information/confidentiality.
Yes

Table 8 to Subpart MMMMM of Part 63 -- List of Hazardous Air Pollutants That Must Be Counted Toward Total HAP Content if Present at 0.1 Percent or More by Weight
Chemical Name
CAS No.
1,1,2,2-Tetrachloroethane
79-34-5
1,1,2-Trichloroethane
79-00-5
1,1-Dimethylhydrazine
57-14-7
1,2-Dibromo-3-chloropropane
96-12-8
1,2-Diphenylhydrazine
122-66-7
1,3-Butadiene
106-99-0
1,3-Dichloropropene
542-75-6
1,4-Dioxane
123-91-1
2,4,6-Trichlorophenol
88-06-2
2,4/2,6-Dinitrotoluene (mixture)
25321-14-6
2,4-Dinitrotoluene
121-14-2
2,4-Toluene diamine
95-80-7
2-Nitropropane
79-46-9
3,3'-Dichlorobenzidine
91-94-1
3,3'-Dimethoxybenzidine
119-90-4
3,3'-Dimethylbenzidine
119-93-7
4,4'-Methylene bis(2-chloroaniline)
101-14-4
Acetaldehyde
75-07-0
Acrylamide
79-06-1
Acrylonitrile
107-13-1
Allyl chloride
107-05-1
alpha-Hexachlorocyclohexane (a-HCH)
319-84-6
Aniline
62-53-3
Benzene
71-43-2
Benzidine
92-87-5
Benzotrichloride
98-07-7
Benzyl chloride
100-44-7
beta-Hexachlorocyclohexane (b-HCH)
319-85-7
Bis(2-ethylhexyl)phthalate
117-81-7
Bis(chloromethyl)ether
542-88-1
Bromoform
75-25-2
Captan
133-06-2
Carbon tetrachloride
56-23-5
Chlordane
57-74-9
Chlorobenzilate
510-15-6
Chloroform
67-66-3
Chloroprene
126-99-8
Cresols (mixed)
1319-77-3
DDE
3547-04-4
Dichloroethyl ether
111-44-4
Dichlorvos
62-73-7
Epichlorohydrin
106-89-8
Ethyl acrylate
140-88-5
Ethylene dibromide
106-93-4
Ethylene dichloride
107-06-2
Ethylene oxide
75-21-8
Ethylene thiourea
96-45-7
Ethylidene dichloride (1,1-Dichloroethane)
75-34-3
Formaldehyde
50-00-0
Heptachlor
76-44-8
Hexachlorobenzene
118-74-1
Hexachlorobutadiene
87-68-3
Hexachloroethane
67-72-1
Hydrazine
302-01-2
Isophorone
78-59-1
Lindane (hexachlorocyclohexane, all isomers)
58-89-9
m-Cresol
108-39-4
Methylene chloride
75-09-2
Naphthalene
91-20-3
Nitrobenzene
98-95-3
Nitrosodimethylamine
62-75-9
o-Cresol
95-48-7
o-Toluidine
95-53-4
Parathion
56-38-2
p-Cresol
106-44-5
p-Dichlorobenzene
106-46-7
Pentachloronitrobenzene
82-68-8
Pentachlorophenol
87-86-5
Propoxur
114-26-1
Propylene dichloride
78-87-5
Propylene oxide
75-56-9
Quinoline
91-22-5
Tetrachloroethene
127-18-4
Toxaphene
8001-35-2
Trichloroethylene
79-01-6
Trifluralin
1582-09-8
Vinyl bromide
593-60-2
Vinyl chloride
75-01-4
Vinylidene chloride
75-35-4


[Federal Register Volume 86, Number 35 (Wednesday, February 24, 2021)]
[Notices]
[Pages 11319-11320]
[FR Doc No: 2021-03765]

-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2021-0002; Internal Agency Docket No. FEMA-B-2103]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report, once effective, will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings.

DATES: Comments are to be submitted on or before May 25, 2021.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location https://hazards.fema.gov/femaportal/prelimdownload and the
respective Community Map Repository address listed in the tables below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
https://msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-2103, to
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance
and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP and are used to calculate the appropriate
flood insurance premium rates for new buildings built after the FIRM
and FIS report become effective.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location
https://hazards.fema.gov/femaportal/prelimdownload and the respective
Community Map Repository address listed in the tables. For communities
with multiple ongoing Preliminary studies, the studies can be
identified by the unique project number and Preliminary FIRM date
listed in the tables. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at https://msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
              Community                 Community map repository address
------------------------------------------------------------------------
              DeKalb County, Alabama and Incorporated Areas
        Project: 18-04-0007S Preliminary Date: September 7, 2020
------------------------------------------------------------------------
City of Rainsville...................  City Hall, 70 McCurdy Avenue
                                        South, Rainsville, AL 35986.
Town of Crossville...................  Town Hall, 14521 Alabama Highway
                                        68, Crossville, AL 35962.
Town of Fyffe........................  Town Hall, 514 Campbell Street,
                                        Fyffe, AL 35971.

Town of Geraldine....................  Town Hall, 41343 Alabama Highway
                                        75, Geraldine, AL 35974.
Town of Henagar......................  City Hall, 9252 Burton Drive,
                                        Henager, AL 35978.
Town of Ider.........................  Town Hall, 10793 Alabama Highway
                                        75, Ider, AL 35981.
Town of Lakeview.....................  Lakeview City Hall, 39333 Alabama
                                        Highway 75, Fyffe, AL 35971.
Town of Powell.......................  Powell Town Hall, 110 Broad
                                        Street North, Fyffe, AL 35971.
Town of Shiloh.......................  Shiloh Town Hall, 2489 Main
                                        Street Shiloh, Rainsville, AL
                                        35986.
Town of Sylvania.....................  Municipal Complex, 22957 Sylvania
                                        Avenue South, Sylvania, AL
                                        35988.
Unincorporated Areas of DeKalb County  DeKalb County Engineer's Office,
                                        111 Grand Avenue Southwest,
                                        Suite 115, Fort Payne, AL 35967.
------------------------------------------------------------------------
              Etowah County, Alabama and Incorporated Areas
        Project: 18-04-0007S Preliminary Date: September 7, 2020
------------------------------------------------------------------------
Town of Sardis City..................  Town Hall, 1335 Sardis Drive,
                                        Sardis City, AL 35956.
Unincorporated Areas of Etowah County  Etowah County Engineer's Office,
                                        402 Tuscaloosa Avenue, Gadsden,
                                        AL 35901.
------------------------------------------------------------------------
             Jackson County, Alabama and Incorporated Areas
        Project: 18-04-0007S Preliminary Date: September 7, 2020
------------------------------------------------------------------------
City of Bridgeport...................  City Hall, 116 Jim B Thomas
                                        Avenue, Bridgeport, AL 35740.
City of Scottsboro...................  City Hall, 316 South Broad
                                        Street, Scottsboro, AL 35768.
City of Stevenson....................  City Hall, 104 Kentucky Avenue,
                                        Stevenson, AL 35772.
Town of Dutton.......................  Jackson County Public Works
                                        Department, 395 Shelby Drive,
                                        Scottsboro, AL 35769.
Town of Hollywood....................  Town Hall, 29164 U.S. Highway 72,
                                        Hollywood, AL 35752.
Town of Langston.....................  Jackson County Public Works
                                        Department, 395 Shelby Drive,
                                        Scottsboro, AL 35769.
Town of Pisgah.......................  Town Hall, 2351 County Road 58,
                                        Pisgah, AL 35765.
Town of Section......................  Town Hall, 72 Dutton Road,
                                        Section, AL 35771.
Unincorporated Areas of Jackson        Jackson County Public Works
 County.                                Department, 395 Shelby Drive,
                                        Scottsboro, AL 35769.
------------------------------------------------------------------------
             Marshall County, Alabama and Incorporated Areas
        Project: 18-04-0007S Preliminary Date: September 7, 2020
------------------------------------------------------------------------
City of Albertville..................  City Hall, 116 West Main Street,
                                        Albertville, AL 35950.
City of Boaz.........................  City Hall, 112 North Broad
                                        Street, Boaz, AL 35957.
City of Guntersville.................  City Hall, 341 Gunter Avenue,
                                        Guntersville, AL 35976.
Unincorporated Areas of Marshall       Marshall County Engineering
 County.                                Department, 424 Blount Avenue,
                                        Suite A337, Guntersville, AL
                                        35976.
------------------------------------------------------------------------
            Frederick County, Maryland and Incorporated Areas
   Project: 14-03-1939S Preliminary Date: September 28, 2018, June 19,
               2020, August 19, 2020, and December 2, 2020
------------------------------------------------------------------------
City of Brunswick....................  City Annex, Planning and Zoning
                                        Department, 601 East Potomac
                                        Street, Brunswick, MD 21716.
City of Frederick....................  City Office Annex, Engineering
                                        Department, 140 West Patrick
                                        Street, 3rd Floor, Frederick, MD
                                        21701.
Town of Burkittsville................  Town Office, 500 East Main
                                        Street, Burkittsville, MD 21718.
Town of Emmitsburg...................  Planning and Zoning Department,
                                        300A South Seton Avenue,
                                        Emmitsburg, MD 21727.
Town of Middletown...................  Municipal Center, 31 West Main
                                        Street, Middletown, MD 21769.
Town of Myersville...................  Town Hall, 301 Main Street,
                                        Myersville, MD 21773.
Town of New Market...................  Town Hall, 39 West Main Street,
                                        New Market, MD 21774.
Town of Thurmont.....................  Town Office, 615 East Main
                                        Street, Thurmont, MD 21788.
Town of Walkersville.................  Town Hall, 21 West Frederick
                                        Street, Walkersville, MD 21793.
Town of Woodsboro....................  Town of Woodsboro Planning and
                                        Zoning Department, Winchester
                                        Hall, 12 East Church Street,
                                        Frederick, MD 21701.
Unincorporated Areas of Frederick      Frederick County Planning and
 County.                                Zoning Department, 30 North
                                        Market Street, Frederick, MD
                                        21701.
Village of Rosemont..................  Office of the Burgess, 3513
                                        Petersville Road, Knoxville, MD
                                        21758.
------------------------------------------------------------------------

[FR Doc. 2021-03765 Filed 2-23-21; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 87, Number 158 (Wednesday, August 17, 2022)]
[Notices]
[Page 50622]
[FR Doc No: 2022-17692]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER22-2472-000]

Lockhart Transmission Holdings, LLC; Supplemental Notice That
Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Lockhart Transmission Holdings, LLC's filing includes a request for
blanket authorization, under 18 CFR part 34, of future issuances of
securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is August 30, 2022.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: August 10, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-17692 Filed 8-16-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: November 19, 2009 (Volume 74, Number 222)]
[Notices]
[Page 59982-59983]
[DOCID:fr19no09-54]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0533]

Draft Guidance for Industry: Recommendations for the Assessment
of Blood Donor Suitability, Blood Product Safety, and Preservation of
the Blood Supply in Response to Pandemic (H1N1) 2009 Virus;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft document entitled ``Draft Guidance for
Industry: Recommendations for the Assessment of Blood Donor
Suitability, Blood Product Safety, and Preservation of the Blood Supply
in Response to Pandemic (H1N1) 2009 Virus''. This draft guidance
provides recommendations for assessing blood donor suitability and
blood product safety and maintaining blood and blood product
availability in response to pandemic (H1N1) 2009 virus. It is intended
for establishments that manufacture Whole Blood and blood components
intended for use in

transfusion and blood components intended for further manufacture,
including recovered plasma, Source Plasma and Source Leukocytes.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by December 3, 2009. The abbreviated comment period is necessary
because pandemic (H1N1) 2009 virus has the potential to cause
disruptions in the blood supply and given this possibility, the agency
needs to finalize the guidance as soon as possible.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in
processing your requests. The draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.
    Submit written comments on the guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Benjamin A. Chacko, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled
``Guidance for Industry: Recommendations for the Assessment of Blood
Donor Suitability, Blood Product Safety, and Preservation of the Blood
Supply in Response to Pandemic (H1N1) 2009 Virus'' dated November 2009.
This draft guidance provides recommendations for assessing blood donor
suitability and blood product safety and maintaining blood and blood
product availability in response to pandemic (H1N1) 2009 virus. It is
intended for establishments that manufacture Whole Blood and blood
components intended for use in transfusion and blood components
intended for further manufacture, including recovered plasma, Source
Plasma and Source Leukocytes. At the present time, FDA is working with
other HHS agencies to monitor the pandemic (H1N1) 2009 virus and its
potential impact on blood availability and blood safety. The agency
notes that the Centers for Disease Control and Prevention (CDC) has
issued a document entitled ``Interim Infection Control Guidance on 2009
H1N1 Influenza for Personnel at Blood and Plasma Collection
Facilities.''\1\ We recognize the importance of the CDC recommendations
for infection control in blood and plasma collection establishments.
---------------------------------------------------------------------------

    \1\ http://www.cdc.gov/h1n1flu/infectioncontrol.
---------------------------------------------------------------------------

    The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent FDA's current thinking on this topic. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.

II. Paperwork Reduction Act of 1995

    The draft guidance refers to previously approved collections of
information found in FDA regulations. The collection of information in
21 CFR part 606 has been approved under OMB control number 0910-0116.
The collection of information for 21 CFR part 601 has been approved
under OMB control number 0910-0338.

III. Comments

    The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may, at any time, submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments regarding the draft guidance.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. A copy of the draft guidance and
received comments are available for public examination in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/guidances/default.htm or http:/
/www.regulations.gov.

    Dated: November 13, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27729 Filed 11-18-09; 8:45 am]

BILLING CODE 4160-01-S