                                                                                Supporting Statement                                       for                         Information Collection Request                                                   Motor Vehicle and Engine Compliance Program Fees (Renewal)                                                                         EPA ICR 2080.08                                                                                Compliance Division                    Office of Transportation and Air Quality                           Office of Air and Radiation                      U.S. Environmental Protection Agency

Part A of the Supporting Statement

1.	Identification of the Information Collection

1(a) Title and Number of the Information Collection 									       Motor Vehicle and Engine Compliance Program Fees (Renewal), ICR 2080.08, OMB 2060-0545.

1(b) Short Characterization

	As required by the Clean Air Act (42 USC 7401 et seq.), the Environmental Protection Agency (EPA or Agency) has regulations establishing emission standards (and other requirements) for various classes of vehicles and engines. In accordance with the Clean Air Act, these regulations also require that a manufacturer demonstrate compliance prior to EPA granting it a "Certificate of Conformity". Such certification is necessary before the product may be introduced into commerce.

	In the case of passenger cars, highway motorcycles, light trucks, and heavy-duty truck engines, EPA has charged fees for administering these compliance programs since 1992. These regulations appeared in 40 CFR Part 86, Subpart J. In 2004, EPA promulgated regulations to add several classes of recently regulated vehicles and engines (referred to as "nonroad" for convenience) to the fees program (69 FR 2621, May 11, 2004, effective July 12, 2004; 40 CFR Part 86, Subpart Y). The Information Collection Request (ICR) for that rule was 2080.02, OMB 2060-0545, the most recent series was renewed until December 31, 2022, in ICR 2080.07. As a part of a rulemaking primarily covering emissions standards for certain nonroad spark-ignition engines and evaporative emissions standards covering a wide variety of engines, vehicles, and evaporative "components", the fees regulations were restated with minor amendments in 40 CFR Part 1027 (73 FR 59034, October 8, 2008). Most notably, these regulations added evaporative component applications to the categories of certifications requiring fees covered by this ICR. This affected the size of the respondent class but did not create any new category of burden. The present ICR 2080.08 is a renewal of the current collection.

	In order for EPA to collect fees and accurately account for them, a certain amount of information is required, such as who is paying the fee, the category of vehicle, engine, evaporative emissions system, or evaporative component "equipment" to which it applies; the name of the vehicle, engine, evaporative, or component engine family/test group; and the method of payment. This information is collected via the main Fee Form. By regulation, fees must be paid before EPA begins its review of a manufacturer's application for certification. This information is used by EPA's Office of Air and Radiation, Office of Transportation and Air Quality, Compliance Division, to ensure that the required fee has been paid before an application for certification is processed; to be sure that we know which vehicle, engine, evaporative, or component engine family/test group a payment is intended to be for; to have a contact person and address in case of payment issues and an address to which acknowledgment of receipt of the payment can be sent; and to provide an early check on other problems, such as failure to name an engine family/test group following EPA's naming rules or failure to go through EPA's manufacturer registration process. It also provides part of the documentation used by EPA's Office of the Chief Financial Officer in processing fee refunds. During model year 2021, 579 separate manufacturing and importing corporate entities filed forms associated with approximately 5109 actions concerning certification fees.

	The Fee Form is an electronic form which is available online at www.Pay.gov. It incorporates fillable sections for filing fees, corrections, miscellaneous payments, and refund requests. The form can be filled online at Pay.gov with or without payment; payment can be made online by credit card, PayPal or electronic funds transfer. Payments may be made offline using an Automated Clearing House (ACH) or wire transactions. The Pay.gov fee form has been issued the EPA Form Number 3520-29.

	It should be noted that this ICR does not include the burden of complying with the actual certification requirements (including the monetary value of the fees themselves); only the burden associated with completing and filing the form is covered here. Substantive certification burdens have been addressed elsewhere, including the on-road certification ICR, 0783 (OMB 2060-0104), and the various ICRs covering the nonroad certification programs.

2.	Need for and Use of the Collection

2(a) Need/Authority for the Collection

	Information supplied on the Fee Form assures that the correct fee for certification has been paid and is posted to the appropriate account. This collection is authorized by the Clean Air Act (42 USC 7552) and the Independent Offices Appropriations Act (31 USC 9701).

2(b) Practical Utility/Users of the Data

	EPA uses the information collected to verify that appropriate fees have been paid and that the amounts are posted to the proper account, that corrections are accurately entered, that fees match the engine families/test groups certified, that refunds are properly processed, and to provide a record in the case of need to audit fee matters. In addition, the forms help ensure that a knowledgeable person can be contacted in case of payment issues and that the applicant is applying for a valid engine family/test group and has a valid manufacturer code attesting completion of EPA's registration process.

3.	Nonduplication, Consultations and Other Collection Criteria

3(a) Nonduplication

	The information contained on the fee form is necessary to link the fees paid with certificate applications. At this time, the data systems containing fees and certification information are linked so that certificates may not be issued before a fee has been paid, however, without the fee form there would be no way to ensure that fees are paid for each engine family/test group prior to certification. In some but not all cases, financial documents (EPA's deposit records and online Treasury resources) contain engine family/test group information in relevant data fields that could be used to associate payments with engine families, but since this information is not always available, it is at present necessary to rely on the Fee Form. In cases where it is clear what a payment is intended to be used for, the necessity to provide a separate form for each engine family/test group being certified may seem to constitute unnecessary duplication. Nonetheless, this requirement has in many cases disclosed problems and mistakes that would not have come to light otherwise. In addition, it is important to have a contact name of someone who is familiar with the fee payment, who is not necessarily the same person as the one who is familiar with the application for certification, particularly in large organizations. It is worth noting in this regard that manufacturers who register with Pay.gov can save their filled-in forms and use them as a template for multiple filings, thus eliminating the need to replicate fields in the forms that do not change from one payment to another.

3(b) Public Notice

	Public comments were previously requested via the Federal Register on April 8, 2022 during a 60-day comment period. No relevant comments were received.  3(c) Consultations

	EPA consulted with the following individuals in preparing this ICR:

	Individual		Firm	 	Thomas Hofmann 		BMW 		 	Alan Parker		Yanmar America	 	Kim Sinacola		General Motors

Kim Sinacola of General Motors had some specific suggestions that would make filling out the fee form more streamlined and user-friendly.

Thomas Hofmann of BMW stated that the current online fee form filing process is easy to use and works very well.

3(d) Effects of Less Frequent Collection

	The Clean Air Act requires that emission certification be done on a yearly basis (42 USC 7525(a)). EPA allows applicants to define their own annual production period, thus granting some flexibility in this regard. However, as certification is an annual event, and the fee is for the work involved in reviewing the certification application, submission of the fee payment information is generally annual.

3(e) General Guidelines

	This information collection activity complies with the requirements of 5 CFR 1320.5(d).

3(f) Confidentiality

	After a certificate of conformity has been issued, most information associated with the manufacturer/importer's application is available to the public. Under section 208 of the Clean Air Act (42 USC 7542(c)) all information, other than trade secret processes or methods, must be publicly available. Information about fee payments is treated as confidential information prior to certification. 	 3(g) Sensitive Questions

	No sensitive questions are asked in this information collection. This collection complies with the Privacy Act and OMB Circular A-108.

4. 	Respondents and Information Requested

4(a) Respondents/SIC Codes

	The respondents are manufacturers or importers of various engines, vehicles, and evaporative components (fuel lines, fuel tanks, and related parts). The following Standard Industrial Classification codes are associated with this information collection:

Category

NAICS Codes (1)

SIC Codes(2)

Examples of Potentially Regulated Entities Industry 333111 3523 Farm Machinery and Equipment Manufacturing Industry 333112 3524 Lawn and Garden Tractor and Home Lawn and Garden Equipment Manufacturing Industry 333120 3531 Construction Machinery Manufacturing Industry 333131 3532 Mining Machinery and Equipment Manufacturing Industry 333132 3533 Oil & Gas Field Machinery Industry 333210 3553 Sawmill & Woodworking Machinery Industry 333924 3537 Industrial Truck, Tractor, Trailer, and Stacker Machinery Manufacturing Industry 333991 3546 Power Driven Handtool Manufacturing Industry 336111 3711 Automotive and Light-Duty Motor Vehicle Manufacturing Industry 336120 3711 Heavy Duty Truck Manufacturing Industry 336213 3716 Motor Home Manufacturing Industry 336311 3592 Motor Vehicle Gasoline Engine and Engine Parts Manufacturing Industry 336312 3714 Gasoline Engine & Engine Parts Manufacturing Industry 336991 3751 Motorcycle, Bicycle, and Parts Manufacturing Industry 336211 3711 Motor Vehicle Body Manufacturing Industry 333618 3519 Gasoline, Diesel & dual-fuel engine Manufacturing Industry 811310 7699 Commercial & Industrial Engine Repair and Maintenance Industry 336999 3799 Other Transportation Equipment Manufacturing  Industry 421110 ------ Independent Commercial Importers of Vehicles and Parts Industry 333612 3731 Manufacturers of marine vessels

3732 Boat building and repairing Industry 333613 3568 Mechanical Power Transmission Equipment Manufacturing Industry 333618 3519 Other Engine Equipment Manufacturing Industry 811112 7533 Commercial importers of vehicles and vehicle components Industry 811198 7549 Automotive services

(1) North American Industry Classification System (NAICS) (2) Standard Industrial Classification (SIC) system code.

4(b) Information Requested

(i) Data items, including recordkeeping requirements.

	Manufacturers of regulated vehicles and engines are required to pay fees to support EPA's compliance activities. As such, they are required to submit certain information and undertake certain actions. A copy of the electronic form has been submitted to the docket. The regulatory provisions governing the content are as follow: 	 	Indication of fee category                            40 CFR 1027.105	 	Request for fee reduction, if applicable	40 CFR 1027.120 	Request for refund, if applicable	40 CFR 1027.125 	Applicant information		40 CFR 1027.130 	 	Reduced fee certificate holders are required to retain records pertaining to the reduced fee calculation for three years after the date of the certificate and produce them within 30 days upon request (40 CFR 1027.120(e)).

(ii) Respondent Activities

	Respondents prepare the Fee Form with the applicant's name and address, the engine family/test group/test group being certified, the amount being paid, the name and email address of a contact person, and the form of payment. If there is a mistake on the form (wrong engine family/test group name, model year, change in manufacturer code, etc.) then the applicant submits the information on the correction portion of the fee form. If there is an underpayment, the applicant normally prepares and submits a fee form with the additional payment. If there has been an overpayment or the application is denied or withdrawn, the applicant may submit the refund request portion of the Fee Form. The Fee Form will also allow application of an overpayment to the fee for an upcoming certification request. This saves manufacturers the trouble and delay of preparing and receiving a refund and saves EPA the burden of processing such refund requests.

	If the aggregate estimated retail sales value of the vehicles, engines, or evaporative components covered by the engine family/test group/evaporative component certified is less than one percent of the full fee, the applicant may file a reduced fee equal to that one percent or $750, whichever is greater. Most such reduced fee applicants are alternative fuel vehicle converters; a few are independent commercial importers, covering certain importers of past model year light vehicles. Such submissions are for a specific number of vehicles. Additional vehicles, engines, or units (such as additional imports) require an amended certificate and submission of additional one percent payments with accompanying fee forms. It is the reduced fee payer's obligation to reconcile sales, actual retail sales, retail sales values, fees paid, and the number of vehicles covered by the certificate.

5. 	The Information Collected--Agency Activities, Collection Methodology, and Information Management

5(a) Agency Activities

	Prior to reviewing an application for certification, EPA certification staff verify that the appropriate fee has been paid. Fees program staff track all fee payments and fee forms. They list as paid and cleared for certification review those families, and only those families, for which a fee form as well as the proper fee payment (including a reduced fee calculation where applicable) have been received. A database of this information is maintained using a computer program dedicated to fees tracking and processing. Fees information is entered from data on the fee forms and then verified. The data file is shared with EPA's certification program, EV-CIS, which prevents the certification of engine families that do not have correct fee payments recorded. The data file is prepared and updated on business days. EPA certification representatives and fees staff use information on fee forms to contact manufacturer representatives in case of problems or other fees business, such as to obtain account information for refund purposes or to clarify necessary procedures. With the aid of the fees computer program, an email is sent to the address of the contact listed on the form acknowledging payment, short payment, or overpayment. EPA's Office of the Chief Financial Officer records deposits to EPA's certification account, which serves as a quality control for the accuracy of the fees program's payment information, and processes fee refund payments.

5(b) Collection Methodology and Management

	Fee payment documentation as well as fee forms are downloaded by EPA fees staff. This documentation and the forms come from Pay.gov forms and payment records and queries to the Federal Transaction Reporting System database. The electronic records and fees database as well as the Office of the Chief Financial Officer's deposit records are available as an ongoing permanent record of fees payments and paperwork.

5(c) Small Entity Flexibility

	Although the reduced fee provisions are not explicitly limited to small entities, nearly all of such applications are from small business alternative fuel converters, or a few Independent Commercial Importers.

5(d) Collection Schedule

	While the manufacturer or importer must obtain certification on an annual basis, they have considerable flexibility in defining their annual production period. The fee must be submitted prior to EPA's processing the application for emission certification. Corrections, refunds, and miscellaneous payments are submitted as the need arises. Reconciliation of reduced fee payments must occur within 45 days of the end of the model year and refunds must be requested within six months of the end of the model year.    6.	Estimating the Burden and Cost of the Collection

(a) Estimating Respondent Burden

	EPA consulted with three manufacturer representatives to determine the burden estimate for competing the fee form (0.2 hours). This is an estimated average; in the latest consultations the time per form estimates ranges from three minutes to 10 minutes per form. There was also a slight difference of time estimated that depended upon the function selected such as a refund request or regular fee payment. The average accounts for these differences.

	Online payment methods, via Pay.gov, include electronic funds transfer, PayPal and credit card. Offline payment options include electronic funds transfer and wire payments. This burden estimate does not include the financial arrangements that manufacturers make for effectuating these and other payments in the course of doing business (i.e., banking arrangements). Manufacturers may make one payment covering several certification fees, as long as the payment can be linked through the fee forms with the engine families being reviewed for certification.

6(b) Estimating Respondent Costs

(i) Estimating Labor Costs.

	Because of the wide variety of industries covered, labor costs are approximated by the motor vehicle manufacturing industry, NAICS 336100. Rates for managers, mechanical engineers, and secretaries (except legal, medical, and executive) are from the May 2020 National Industry-Specific Occupational Employment and Wage Estimates (http://www.bls.gov/oes/current/naics4_336100.htm, accessed March 10, 2022). With a 160 percent overhead multiplier, the hourly wage estimates are $102.99, $72.61, and $39.58, respectively. For some manufacturers, filing fee forms is largely secretarial; many others use technicians, and many foreign manufacturers hire local agents to handle application mechanics. Manufacturers' estimates of time were used to estimate the time spent by each labor category per activity.

(ii) Estimating Capital and Operations and Maintenance Costs

	The paperwork cost estimate includes a recordkeeping cost of $2.42 per item. This cost includes an increase over the previous estimate for inflation. No other Capital and Operations and Maintenance Costs are applicable.

(iii) Capital/Start-up vs. Operating and Maintenance (O&M) Costs

	There are no capital or start-up costs associated with this collection.

6(c) Estimating Agency Burden

	The overall administration of the fees program is conducted by a fees team in EPA's Compliance Division. Secondarily, it is administered by each of the certification representatives in the division, who have a responsibility to determine that fees have been paid prior to certification review, and by EPA's contractor. Updates have been made to the certification portion of EPA's Engine and Vehicle Compliance Information System (EV-CIS) that shows whether fees have been paid for an engine family/test group. This reduces the amount of time that certification engineers need to spend researching the fees before certification. If the system shows that a fee has not been paid, the certification engineer will need to do some research, as in prior years, but this situation represents a small fraction of applications for certification that are received. In addition, EPA's Office of the Chief Financial Officer keeps deposit records and processes fee refunds. Twenty percent of three GS 12/3 full time equivalent (FTE) employees are allocated to the fees team. An additional three quarters of one percent of 25 FTE and six SEE employees is also allocated to fees-related activity in the process of certification reviews. Although the numbers of FTEs and SEEs may fluctuate, the average number of hours per action spent on this activity remains the same because fees must be checked before each certificate is issued. Government cost is based on a GS-12/3 general schedule salary for ($71,825 per year) obtained from the Office of Personal Management 2021 Salary Table; and an average of $68,161per year for SEE employees, with a 1.6 multiplier for overhead applied to both. The contract work for the upcoming period is estimated as $85,790 based on actual contract cost for one year. The OCFO cost is estimated as 302 hours, $10,350 annually. The estimated total Agency cost is $248,551.

6(d) Estimating the Respondent Universe and Total Burden and Costs

	Our certification fees database for model year 2021 lists 579 separate manufacturers that submitted fees. These respondents vary from large, multinational corporations to small independent commercial importers.

	EPA estimated the numbers of activities where a fee form was submitted including fee payments, corrections, miscellaneous payments, reduced fee payments and refund requests received for model year 2021 vehicles. The total estimated number of fees-related transactions for that model year is 5109.

6(e) Bottom Line Burden Hours and Cost

(i) Respondent Tally

	Bottom-line burden and costs per year for the combined on-road and nonroad certification fees program are summarized in Table 1. EPA estimates a total of 5109 responses and 1022 hours per year for the next three years at a total cost to the industry of $77,444, of which $12,364 is allocated to O&M and $65,080 to labor.

(ii) Agency tally

	EPA estimates that it takes the agency approximately 3622 hours and $248,551 per year to administer the entire certification fees program.

6(f) Reasons for Change in Burden

	Changes from the last ICR are the result of the change to wages. The labor per transaction is the same and the number of fees transactions has changed very little, about three hours per year. Total costs, including labor, have increased from $67,445 to $77.444.27, an increase of about $10,000. This increase reflects change in labor costs which resulted in a slight increase in burden.

	                                     Table 1

6(g) Burden Statement

      The annual public reporting burden for this collection of information is estimated to average .2 hours per response.

      Burden means the total time, effort, and financial resources expended by persons to generate, maintain, retain, disclose, or provide information to or for a federal agency. This includes the time needed to review instructions; 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; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and 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 EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

      To comment on EPA 's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID Number EPA-HQ-OAR-2013-0119, which is available for online viewing at www.regulations.gov, or in person viewing at the EPA Docket Center (EPA/DC), WJC West, Room 3334, 1301 Constitution Avenue, NW, Washington, D.C.  The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.  The telephone number for the Reading Room is<PHONE_NUMBER>. An electronic version of the public docket is available at www.regulations.gov.  This site can be used to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically.  When in the system, select "search," then key in the Docket ID Number identified above.  Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, D.C. 20503, Attention: Desk Officer for EPA.  Please include the EPA Docket ID Number EPA-HQ-OAR-2013-0119 and OMB Control Number 2060-0545 in any correspondence.

Attachment I

Legal Authority

42 USC 7552. - Motor vehicle compliance program fees   (a)  Fee collection. Consistent with section 9701 of title 31, the Administrator may promulgate (and from time to time revise) regulations establishing fees to recover all reasonable costs to the Administrator associated with - (1) new vehicle or engine certification under section 7525(a) of this title or part C of this subchapter, (2) new vehicle or engine compliance monitoring and testing under section 7525(b) of this title or part C of this subchapter, and (3) in-use vehicle or engine compliance monitoring and testing under section 7541(c) of this title or part C of this subchapter.  The Administrator may establish for all foreign and domestic manufacturers a fee schedule based on such factors as the Administrator finds appropriate and equitable and nondiscriminatory, including the number of vehicles or engines produced under a certificate of conformity. In the case of heavy-duty engine and vehicle manufacturers, such fees shall not exceed a reasonable amount to recover an appropriate portion of such reasonable costs.

(b)  Special Treasury fund. Any fees collected under this section shall be deposited in a special fund in the United States Treasury for licensing and other services which thereafter shall be available for appropriation, to remain available until expended, to carry out the Agency's activities for which the fees were collected.

(c)  Limitation on fund use. Moneys in the special fund referred to in subsection (b) of this section shall not be used until after the first fiscal year commencing after the first July 1 when fees are paid into the fund.

(d)  Administrator's testing authority. Nothing in this subsection shall be construed to limit the Administrator's authority to require manufacturer or confirmatory testing as provided in this part

31 USC. 9701. - Fees and charges for Government services and things of value

(a) It is the sense of Congress that each service or thing of value provided by an agency (except a mixed-ownership Government corporation) to a person (except a person on official business of the United States Government) is to be self-sustaining to the extent possible.

(b)The head of each agency (except a mixed-ownership Government corporation) may prescribe regulations establishing the charge for a service or thing of value provided by the agency. Regulations prescribed by the heads of executive agencies are subject to policies prescribed by the President and shall be as uniform as practicable. Each charge shall be - (1) fair; and (2) based on - (A) the costs to the Government; (B) the value of the service or thing to the recipient; (C) public policy or interest served; and (D) other relevant facts.

(c)This section does not affect a law of the United States - (1) prohibiting the determination and collection of charges and the disposition of those charges; and (2) prescribing bases for determining charges, but a charge may be determined under this section consistent with the prescribed bases.


Date: May 30, 2003 Subject: Revised MACT Floor, Regulatory Alternatives, and Impacts for Small Tanks at Chemical Manufacturing Facilities Miscellaneous Organic NESHAP EPA Project No. 95/ 08;

From: Brenda Shine, North State Engineering, Inc.

To: MON Project File I. Introduction This memorandum describes existing and new source MACT floors for storage tanks with capacities less than 10,000 gallons.

II. Discussion A. Background As part of the information gathering phase for the development of this standard, EPA collected information on storage tanks associated with miscellaneous organic chemical manufacturing facilities. However, because storage tanks are commonly defined by existing regulations as having capacities greater than 10,000 gallons, we did not specifically request information for tanks with capacities of less than 10,000 gallons. Recently, we have tried to address the need to establish MACT floors for all potential sources of emissions, including small tanks ( those below 10,000 gallon capacity). This memorandum presents the results of a MACT floor analysis for small tanks.

B. MACT Floor for Existing Sources Although we did not request specific information, some facilities reported information for tanks with capacities of less than 10,000 gallons. These data are presented in Table 1. A total of 19 tanks from 8 facilities were reported with capacities of less than 10,000 gallons. For comparison, there were a total of 1,195 tanks with capacities greater than or equal to 10,000 gal at 132 facilities in the MON database. We recognize that our subset of data for small tanks makes up a relatively small fraction of overall tanks, and that the amount of data we have may not be representative of the industry for setting the MACT floor. Of the 5 tanks in Table 1 that are reported to be controlled, the first 4 are located at the same facility, while tank record No. 5 is 2 located at a second facility. Additionally, Tank record No. 5 is a portable tank, based on subsequent discussion with the tank operator. 1 In setting MACT floors for less than 30 sources, EPA bases the floor on the best 5 facilities. Therefore, we conclude that for small tanks, there is essentially a " no emission reduction MACT floor", since we do not have enough data to set the floor and because only one of the top 5 facilities is implementing control.

C. Regulatory Alternative Above the Floor for Existing Sources To develop a regulatory alternative above the floor for small tanks, we considered the analysis that had been conducted for our populations of larger tanks ( greater than 10,000 gallons). 2 In this analysis, we estimated the cost effectiveness of controlling horizontal tanks with condensers, since these could not be fitted with the more cost effective floating roof controls. The same is true for small capacity ( less than 10,000 gallon) tanks, and therefore we considered the previous cost analysis applicable. The analysis consisted of estimating uncontrolled emissions using tank throughputs reported in the Section 114 information requests. Generally, tanks close to 10,000 gallons and a HAP partial pressure of 1 psia were estimated to be generating uncontrolled emissions on the order of less than 1,000 lb/ yr, with a few exceptions that appear to result from uncharacteristically high throughputs. The same effect can be seen in Tank Record 11 of Table 1, where a 7,500 gallon tank was reported to have a throughput in excess of 12 million gallons a year. This tank experiences numerous turnovers per day ( a minimum of 5 a day), indicating that its service is more likely as a process tank. From this analysis, we concluded that controlling tanks with capacities less than 10,000 gallons per day and storing materials with a HAP partial pressure of at least 1 psia would not be cost effective, based on values in the regulatory analysis on the order of $ 200,000/ ton to $ 300,000/ ton. On average, condenser control per storage tank would consume about 3,100 kwh/ yr of electricity, and generating the electricity would use about 30.0 million Btu/ yr of fuel energy ( coal) and generate about 0.025 Mg/ yr of CO, NO x, SO 2, and PM 10 emissions. If the condensed HAP cannot be returned to the tank or used elsewhere, then about 1,000 lb of waste would be generated per tank. Therefore, we concluded that there would be no cost effective regulatory alternatives above the floor for smaller tanks with the throughput and HAP partial pressures characteristics in Table 1.

D. MACT Floor for New Sources We also reviewed the data in Table 1 to establish a MACT floor for new sources. We concluded that Tank Record No. 5 would not be representative of similar sources because it is a portable tank. We selected the characteristics of Tank Record No. 4 to be the best controlled similar source, with a capacity of 9,800 gallons and storing a material with a HAP partial pressure of 0.373 psia ( rounded to 0.4 psia). We considered this tank to be more stringently controlled than the 8,000 gallon tank storing a material with a HAP partial pressure of 0.574 psia because partial pressure is the best indicator of emission potential, and controlling a lower partial pressure is an indication of increasing stringency. This tank selected as the new source MACT floor is controlled with a thermal oxidizer that has an efficiency in excess of 98 percent. We compared this tank's characteristics to the new source MACT floor for larger tanks, which was set at 95 percent control for tanks with capacities of greater than 10,000 gallons and storing materials 3 Table 1. Summary of Data for Small Tanks Record Number HAP Partial Pressure ( psia) Control Device Control Efficiency (%) Capacity ( Gallons) Throughput ( GPY) Uncontrolled Emissions ( lb/ yr) Controlled Emissions ( lb/ yr)

1 0.013 Carbon Adsorber 70 6,000 6,660 0.88 0.27 2 0.373 Carbon Adsorber 70 6,000 226,983 240.97 72.29 3 0.574 Thermal Oxidizer 99 8,000 19,800 104.15 1.042 4 0.373 Thermal Oxidizer 99 9,800 226,983 270.61 2.71 5 0.373 Thermal Oxidizer 99 1,400 15,656 23.78 0.24 6 0.08 None NA 8,000 30,900 19.44 19.44 7 0.002 None NA 8,000 107,677 0.47 0.47 8 0.003 None NA 7,807 1,038,000 3.52 3.52 9 0.003 None NA 7,807 1,100,000 3.6 3.6 10 0.003 None NA 7,807 1,038,000 3.6 3.6 11 0.02 None NA 7,500 12,301,281 1,668.2 1,668.2 12 0.05 None NA 500 100,000 2.6 2.6 13 0.05 None NA 500 100,000 2.6 2.6 14 0.05 None NA 500 100,000 2.6 2.6 15 0.05 None NA 500 100,000 2.6 2.6 16 0.496 None NA 8,750 133,874 216.1 216.1 17 0.496 None NA 8,750 133,874 216.1 216.1 18 0.373 None NA 6,000 51,375 87.6 87.6 19 0.373 None NA 6,000 51,375 87.6 87.6 with HAP partial pressures of 0.1 psia or higher. We concluded that the proposed new source MACT floor for larger tanks is more stringent than a floor based on 98 percent reduction for tanks storing material with a HAP partial pressure greater than or equal to 0.4 psia. From our existing population of tanks, we found that approximately 10 percent greater overall reduction would be achieved by controlling all tanks with HAP partial pressures of at least 0.1 psia at 95 percent than by controlling tanks storing materials with partial pressures greater than 0.4 at 98 percent. Additionally, requiring 95 percent control allows the use of floating roofs and consequently provides a pollution prevention option in lieu of requiring end of pipe control. Therefore, we considered the new source MACT floor originally developed to be appropriate ( 95 percent control of all tanks with capacities of 10,000 gallons and storing material with a HAP partial pressure of at least 0.1 psia) for all tanks. 4 III. References 1. Telecon. R. McDonald, EPA, with J. Bowers, Cook Composite Products. May 29, 2003. Information Regarding Small Xylene Storage Tank.

2. Memorandum from D. Randall and J. Fields, Midwest Research Institute, to the Miscellaneous Organic NESHAP Project File, July 31, 2000. MACT Floor, Regulatory Alternatives, and Nationwide Impacts for Storage Tanks at Miscellaneous Organic Chemical Manufacturing Facilities.


[Federal Register Volume 78, Number 199 (Tuesday, October 15, 2013)]
[Notices]
[Page 62299]
[FR Doc No: 2013-24457]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 2

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER13-2386-000.
    Applicants: Lakeswind Power Partners, LLC.
    Description: Supplement to September 16, 2013 Lakeswind Power
Partners, LLC tariff filing.
    Filed Date: 10/7/13.
    Accession Number: 20131007-5115.
    Comments Due: 5 p.m. ET 10/28/13.

    Docket Numbers: ER14-44-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: 10-07-13 Scheds 7 8 9 re PPI to be effective 6/1/2013.
    Filed Date: 10/7/13.
    Accession Number: 20131007-5086.
    Comments Due: 5 p.m. ET 10/28/13.

    Docket Numbers: ER14-45-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: 10-07-2013 SA 1558 Forward Energy-ATC LGIA to be
effective 10/8/2013.
    Filed Date: 10/7/13.
    Accession Number: 20131007-5095.
    Comments Due: 5 p.m. ET 10/28/13.

    Docket Numbers: ER14-46-000.
    Applicants: AEP Texas North Company.
    Description: TNC-Concho Valley EC-Golden Spread EC IA Amend
1 to be effective 9/10/2013.
    Filed Date: 10/7/13.
    Accession Number: 20131007-5109.
    Comments Due: 5 p.m. ET 10/28/13.

    Take notice that the Commission received the following foreign
utility company status filings:

    Docket Numbers: FC14-1-000.
    Applicants: Boryszewo Wind Invest Sp. Zoo.
    Description: Self-Certification of Foreign Utility Company Status
of Boryszewo Wind Invest Sp. Zoo.
    Filed Date: 10/7/13.
    Accession Number: 20131007-5014.
    Comments Due: 5 p.m. ET 10/28/13.

    Docket Numbers: FC14-2-000.
    Applicants: Krupy Wind Invest Sp. Zoo.
    Description: Self-Certification of Foreign Utility Company Status
of Krupy Wind Invest Sp. Zoo.
    Filed Date: 10/7/13.
    Accession Number: 20131007-5016.
    Comments Due: 5 p.m. ET 10/28/13.

    Docket Numbers: FC14-3-000.
    Applicants: Nowy Jaroslaw Invest Sp. Zoo.
    Description: Self-Certification of Foreign Utility Company Status
of Nowy Jaroslaw Invest Sp. Zoo.
    Filed Date: 10/7/13.
    Accession Number: 20131007-5017.
    Comments Due: 5 p.m. ET 10/28/13.

    Docket Numbers: FC14-4-000.
    Applicants: Stary Jarolslaw Invest Sp. Zoo.
    Description: Self-Certification of Foreign Utility Company Status
of Stary Jarolslaw Invest Sp. Zoo.
    Filed Date: 10/7/13.
    Accession Number: 20131007-5019.
    Comments Due: 5 p.m. ET 10/28/13.

    Docket Numbers: FC14-5-000.
    Applicants: Sandringham Solar Energy Partnership.
    Description: Self-Certification of Foreign Utility Company Status
of Sandringham Solar Energy Partnership.
    Filed Date: 10/7/13.
    Accession Number: 20131007-5020.
    Comments Due: 5 p.m. ET 10/28/13.

    Docket Numbers: FC14-6-000.
    Applicants: Woodville Solar Energy Partnership.
    Description: Self-Certification of Foreign Utility Company Status
of Woodville Solar Energy Partnership.
    Filed Date: 10/7/13.
    Accession Number: 20131007-5021.
    Comments Due: 5 p.m. ET 10/28/13.

    Docket Numbers: FC14-7-000.
    Applicants: Bettyhill Wind Energy Limited.
    Description: Self-Certification of Foreign Utility Company Status
of Bettyhill Wind Energy Limited.
    Filed Date: 10/7/13.
    Accession Number: 20131007-5022.
    Comments Due: 5 p.m. ET 10/28/13.

    Docket Numbers: FC14-8-000.
    Applicants: Gorzyca Wind Invest Sp. Zoo.
    Description: Self-Certification of Foreign Utility Company Status
of Gorzyca Wind Invest Sp. Zoo.
    Filed Date: 10/7/13.
    Accession Number: 20131007-5023.
    Comments Due: 5 p.m. ET 10/28/13.

    Docket Numbers: FC14-9-000.
    Applicants: Pekanino Wind Invest Sp. Zoo.
    Description: Self-Certification of Foreign Utility Company Status
of Pekanino Wind Invest Sp. Zoo.
    Filed Date: 10/7/13.
    Accession Number: 20131007-5024.
    Comments Due: 5 p.m. ET 10/28/13.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 7, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-24457 Filed 10-11-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: June 11, 2008 (Volume 73, Number 113)]
[Notices]
[Page 33081-33082]
[DOCID:fr11jn08-44]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0255; FRL-8364-9]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Foreign Purchaser Acknowledgment Statement of
Unregistered Pesticides; EPA ICR No. 0161.11, OMB Control No. 2070-0027

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) to the Office of Management and Budget (OMB). This ICR,
entitled: ``Foreign Purchaser Acknowledgment Statement of Unregistered
Pesticides'' and identified by EPA ICR No. 0161.11 and OMB Control No.
2070-0027, is scheduled to expire on February 28, 2009. Before
submitting the ICR to OMB for review and approval, EPA is soliciting
comments on specific aspects of the proposed information collection.

DATES: Comments must be received on or before August 11, 2008.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2008-0255, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2008-0255. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://
www.regulations.gov, or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The hours of operation of this
Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Nathanael R. Martin, Field and
External Affairs Division (7506P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What Information is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of PRA, EPA specifically solicits
comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

II. What Should I Consider when I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the collection activity.
    7. Make sure to submit your comments by the deadline identified
under DATES.
    8. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response.

You may also provide the name, date, and Federal Register citation.

III. What Information Collection Activity or ICR Does this Action Apply
to?

    Affected entities: Entities potentially affected by this action are
a business engaged in the manufacturing of pesticides and other
agricultural chemicals. Potentially affected entities may include, but
are not limited to: Manufacturers of pesticides and other agricultural
chemicals (NAICS code 325320), e.g., exporters of unregistered
pesticide products. This listing is not intended to be exhaustive, but
rather provides a guide for readers regarding entities likely to be
affected by this action. Other types of entities not listed above could
also be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. To
determine whether you or your business may be affected by this action,
you should carefully examine the applicability provisions in 40 CFR
168.75.
    Title: Foreign Purchaser Acknowledgment Statement of Unregistered
Pesticides.
    ICR numbers: EPA ICR No. 0161.11, OMB Control No. 2070-0027.
    ICR status: This ICR is currently scheduled to expire on February
28, 2009. 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 EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register when approved, are listed in 40 CFR part 9, are displayed
either by publication in the Federal Register or by other appropriate
means, such as on the related collection instrument or form, if
applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: This information collection program is designed to enable
EPA to provide notice to foreign purchasers of unregistered pesticides
exported from the United States that the pesticide product cannot be
sold in the United States. Section 17(a)(2) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) requires an exporter of any
pesticide not registered under FIFRA section 3 or sold under FIFRA
section 6(a)(1) to obtain a signed statement from the foreign purchaser
acknowledging that the purchaser is aware that the pesticide is not
registered for use in, and cannot be sold in, the United States. A copy
of this statement must be transmitted to an appropriate official of the
government in the importing country. The purpose of the purchaser
acknowledgment statement requirement is to notify the government of the
importing country that a pesticide judged hazardous to human health or
the environment, or for which no such hazard assessment has been made,
will be imported into that country. This information is submitted in
the form of annual or per shipment statements to EPA, which maintains
original records and transmits copies thereof to appropriate government
officials of the countries which are importing the pesticides.
    Burden statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 1.06
hours (around 65 minutes) per response. 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 review instructions;
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; adjust the existing ways to comply with any previously
applicable instructions and requirements which have subsequently
changed; train personnel to be able to respond to a collection of
information; search data sources; complete and review the collection of
information; and transmit or otherwise disclose the information.
    The ICR provides a detailed explanation of this estimate, which is
only briefly summarized here:
    Estimated total number of potential respondents: 2,500.
    Frequency of response: Annual or per shipment.
    Estimated total average number of responses for each respondent: 1-
2.
    Estimated total annual burden hours: 24,492 hours.
    Estimated total annual costs: $1,574,306.

IV. Are There Changes in the Estimates from the Last Approval?

    There is a decrease of 208 hours in the total estimated respondent
burden compared with that identified in the ICR currently approved by
OMB. This decrease reflects the average annual number of respondents
per calendar year from 2005-2007. The decrease in annual reporting and
recordkeeping cost is an adjustment that reflects the Agency's new
estimates of wages, benefits, and overhead for all labor categories for
affected industries, state government, and EPA employees. This change
is an adjustment.

V. What is the Next Step in the Process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce
the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about this ICR or
the approval process, please contact the person listed under FOR
FURTHER INFORMATION CONTACT.

List of Subjects

    Environmental protection, Reporting and recordkeeping requirements.

    Dated: June 2, 2008.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. E8-13006 Filed 6-10-08; 8:45 am]

BILLING CODE 6560-50-S


Lydia Wegman/RTP/USEPA/US

06/18/2007 09:49 AM

To

<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS> cc

<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>Janet McDonald/RTP/USEPA/US@EPA, Tricia Crabtree/RTP/USEPA/US@EPA, <EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS> Subject

Fw: redline of sections IV.D-F of the O3 NPR (secondary standard sections) -- pdf file

Here is the secondary standard section on adequacy of the current standard and proposed revisions to the standard.

----- Forwarded by Lydia Wegman/RTP/USEPA/US on 06/18/2007 09:47 AM -----

Karen Martin/RTP/USEPA/US

06/18/2007 09:30 AM

To

Wegman Lydia@EPA

cc

Vicki Sandiford/RTP/USEPA/US@EPA, Dave Mckee/RTP/USEPA/US@EPA

Subject

redline of sections IV.D-F of the O3 NPR (secondary standard sections) -- pdf file

Karen Martin, Ph.D.

Office of Air Quality Planning and Standards

U.S. EPA (C504-06)

Research Triangle Park, NC 27711

phone:<PHONE_NUMBER>

fax:<PHONE_NUMBER>

<EMAIL_ADDRESS>


[Federal Register Volume 79, Number 174 (Tuesday, September 9, 2014)]
[Notices]
[Pages 53488-53490]
[FR Doc No: 2014-21389]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72971; File No. SR-NYSEARCA-2014-92]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Amending the NYSE
Arca Options Fee Schedule and, Through Its Wholly Owned Subsidiary NYSE
Arca Equities, Inc. Amending the NYSE Arca Equities Schedule of Fees
and Charges for Exchange Services, To Establish a Billing Practice With
Respect to Billing Disputes

September 3, 2014.
    Pursuant to Section 19(b)(1)\1\ of the Securities Exchange Act of
1934 (the ``Act'')\2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on August 28, 2014, NYSE Arca, Inc. (the ``Exchange'' or
``NYSE Arca'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S. C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the NYSE Arca Options Fee Schedule
(``Options Fee Schedule'') and, through its wholly owned subsidiary
NYSE Arca Equities, Inc. (``NYSE Arca Equities''), to amend the NYSE
Arca Equities Schedule of Fees and Charges for Exchange Services
(``Equities Fee Schedule'' and, together with the Options Fee Schedule,
``Fee Schedules''), to establish a billing practice with respect to
billing disputes. The text of the proposed rule change is available on
the Exchange's Web site at www.nyse.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend the Fee Schedules to establish a
billing practice to prevent members \4\ from contesting their bills
long after they have been sent an invoice. In accordance with the
proposed rule change, members must submit all disputes no later than
sixty calendar days after receipt of an Exchange invoice. After sixty
calendar days, all fees assessed by the Exchange will be considered
final. The Exchange provides members with both daily and monthly fee
reports and thus believes members should be aware of any potential
billing errors within sixty calendar days of receiving an invoice.
Requiring that members dispute an invoice within this time period will
encourage them to review their invoices promptly so that any disputed
charges can be addressed in a timely manner while the information and
data underlying those charges (e.g., applicable fees and order
information) is still easily and readily available. This practice will
avoid issues that may arise when members do not dispute an invoice in a
timely manner, and will conserve Exchange resources that would have to
be expended to resolve untimely billing disputes. The Exchange notes
that this type of provision is common among many other exchanges.\5\
---------------------------------------------------------------------------

    \4\ For the purposes of this filing, for NYSE Arca Equities, the
term ``members'' refers to ``ETP Holders'' as defined in NYSE Arca
Equities Rule 1.1(n), and for NYSE Arca, the term ``members'' refers
to ``OTP Holders'' and ``OTP Firms'' as defined in NYSE Arca Rules
1.1(q) and 1.1(r).
    \5\ See Securities Exchange Act Release No. 72410 (June 17,
2014), 79 FR 35605 (June 23, 2014) (SR-MIAX-2014-27); Securities
Exchange Act Release No. 71286 [sic] (January 14, 2014), 79 FR 3442
(January 21, 2014) (SR-ISE-2014-02); Securities Exchange Act Release
No. 62661 (August 6, 2010), 75 FR 49544 (August 13, 2010) (SR-Phlx-
2010-110).
---------------------------------------------------------------------------

    The Exchange also proposes to state that all billing disputes must
be submitted to the Exchange in writing,\6\ and must be accompanied by
supporting documentation. The Exchange believes that this requirement,
which is also similar to requirements of other

exchanges,\7\ will further streamline the billing dispute process.
---------------------------------------------------------------------------

    \6\ The Exchange invoice specifies contact information for
billing inquiries.
    \7\ See supra note 5.
---------------------------------------------------------------------------

    In addition, in order for members to be fully aware of this rule
regarding fee disputes, the Exchange proposes to include it on the Fee
Schedules and at the bottom of each invoice regarding the handling of
billing disputes.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\8\ in general, and furthers the
objectives of Sections 6(b)(4) and (5) of the Act,\9\ in particular,
because it is designed to promote just and equitable principles of
trade, to remove impediments to and perfect the mechanism of a free and
open market and a national market system, and, in general, to protect
investors and the public interest.
---------------------------------------------------------------------------

    \8\ 15 U.S. C. 78f(b).
    \9\ 15 U.S. C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange believes the requirement to submit all billing
disputes in writing, and with supporting documentation, within sixty
calendar days from receipt of the invoice, is reasonable in the public
interest because the Exchange provides ample tools to properly and
swiftly monitor and account for various charges incurred in a given
month. Also, the proposal is equitable because it applies equally to
all members. The proposed provision regarding fee disputes in the Fee
Schedules promotes the protection of investors and the public interest
by providing a clear and concise mechanism in Exchange Rules for
members to dispute fees and for the Exchange to review such disputes in
a timely manner. In addition, the proposed 60-day limitation is fair
and equitable because it will be implemented prospectively on all
members, only applying to invoices issued after the proposed rule
change becomes operative. Moreover, the proposed billing dispute
language, which will lower the Exchange's administrative burden, is
substantially similar to billing dispute language adopted by other
exchanges.\10\
---------------------------------------------------------------------------

    \10\ See supra note 4.
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    In accordance with Section 6(b)(8) of the Act,\11\ the Exchange
does not believe that the proposed rule change will impose any burden
on intermarket or intramarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. As stated above,
the proposed rule change, which applies equally to all members, is
intended to reduce the Exchange's administrative burden, and is
substantially similar to rules adopted by other exchanges. Because the
Exchange does not propose any substantive changes regarding fees
applicable to members, the proposal does not impose any burden on
competition.
---------------------------------------------------------------------------

    \11\ 15 U.S. C. 78f(b)(8).
---------------------------------------------------------------------------

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \12\ and Rule 19b-4(f)(6) thereunder.\13\
Because the proposed rule change does not: (i) significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
---------------------------------------------------------------------------

    \12\ 15 U.S. C. 78s(b)(3)(A)(iii).
    \13\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \14\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\15\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest.
---------------------------------------------------------------------------

    \14\ 17 CFR 240.19b-4(f)(6).
    \15\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \16\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \16\ 15 U.S. C. 78s(b)(2)(B).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEARCA-2014-92 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEARCA-2014-92. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S. C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal offices of the Exchange.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-NYSEARCA-2014-
92, and should be submitted on or before September 30, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

    \17\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O' Neill,
Deputy Secretary.
[FR Doc. 2014-21389 Filed 9-8-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 167 (Wednesday, September 1, 2021)]
[Notices]
[Pages 49021-49022]
[FR Doc No: 2021-18807]

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 ENVIRONMENTAL PROTECTION AGENCY

[FRL-8758-01-OA]

Request for Nominations to the Science Advisory Board Biosolids
Chemical Risk Assessment Panel

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) Science Advisory
Board (SAB) Staff Office requests public nominations of scientific
experts to form a panel to review the EPA White Paper: A Standardized
Approach to Biosolids Chemical Risk Assessment and a Biosolids
Screening Tool with an accompanying User Guide. The White Paper, which
includes a prioritization method, deterministic screening model, and a
probabilistic risk assessment modeling framework will be used to
modernize, standardize, and streamline the risk assessment process to
efficiently and thoroughly assess risk to chemical pollutants found in
biosolids.

DATES: Nominations should be submitted by September 22, 2021 per the
instructions below.

FOR FURTHER INFORMATION CONTACT: Any member of the public wishing
further information regarding this Notice and Request for Nominations
may contact Dr. Shaunta Hill-Hammond, Designated Federal Officer (DFO),
EPA Science Advisory Board Staff Office by telephone/voice mail (202)
564-3343, or email at<EMAIL_ADDRESS>General information
concerning the EPA SAB can be found at the EPA SAB website at http://www.epa.gov/sab.

SUPPLEMENTARY INFORMATION:
    Background: The SAB (42 U.S.C. 4365) is a chartered Federal
Advisory Committee that provides independent scientific and technical
peer review, advice, and recommendations to the EPA Administrator on
the technical basis for EPA actions. As a Federal Advisory Committee,
the SAB conducts business in accordance with the Federal Advisory
Committee Act (FACA) (5 U.S.C. App. 2) and related regulations. The SAB
Staff Office is forming an expert panel, the Biosolids Chemical Risk
Assessment (Biosolids) Panel, under the auspices of the Chartered SAB.
The Biosolids Panel will provide advice through the chartered SAB. The
SAB and the Biosolids Panel will comply with the provisions of FACA and
all appropriate SAB Staff Office procedural policies.
    The Biosolids Panel will conduct the review of the EPA White Paper:
A Standardized Approach to Biosolids Chemical Risk Assessment and a
Biosolids Screening Tool (BST) with an accompanying User Guide prepared
by the EPA's Office of Water. The White Paper, BST and User Guide
present the EPA's proposed screening process to identify pollutants,
pathways and receptors of greatest interest and inform decisions
regarding the need for refined risk assessment of land-applied
biosolids.
    Request for Nominations: The SAB Staff Office is seeking
nominations of nationally and internationally recognized scientists
with demonstrated expertise in the following disciplines: Biosolids
management, risk assessment, exposure assessment, probabilistic
modeling, and deterministic modeling.
    Process and Deadline for Submitting Nominations: Any interested
person or organization may nominate qualified individuals in the areas
of expertise described above for possible service on the SAB Panel.
Individuals may self-nominate. Nominations should be submitted in
electronic format (preferred) following the instructions for
``Nominating Experts to Advisory Panels and Ad Hoc Committees Being
Formed,'' provided on the SAB website (see the ``Nomination of
Experts'' link under ``Current Activities'' at http://www.epa.gov/sab).
To be considered, nominations should include the information requested
below. EPA values and welcomes diversity. All qualified candidates are
encouraged to apply regardless of sex, race, disability, or ethnicity.
Nominations should be submitted in time to arrive no later than
September 22, 2021.
    The following information should be provided on the nomination
form: Contact information for the person making the nomination; contact
information for the nominee; and the disciplinary and specific areas of
expertise of the nominee. Nominees will be contacted by the SAB Staff
Office and will be asked to provide a recent curriculum vitae and a
narrative biographical summary that includes current position;
educational background; research activities; sources of research
funding for the last two years; and recent service on other national
advisory committees or national professional organizations. Persons
having questions about the nomination procedures, or who are unable to
submit nominations through the SAB website, should contact the DFO at
the contact information noted above. The names and biosketches of
qualified nominees identified by

respondents to this Federal Register notice, and additional experts
identified by the SAB Staff Office, will be posted in a List of
Candidates for the Panel on the SAB website at http://www.epa.gov/sab.
Public comments on the List of Candidates will be accepted for 21 days.
The public will be requested to provide relevant information or other
documentation on nominees that the SAB Staff Office should consider in
evaluating candidates.
    For the EPA SAB Staff Office a balanced review panel includes
candidates who possess the necessary domains of knowledge, the relevant
scientific perspectives (which, among other factors, can be influenced
by work history and affiliation), and the collective breadth of
experience to adequately address the charge. In forming the expert
panel, the SAB Staff Office will consider public comments on the Lists
of Candidates, information provided by the candidates themselves, and
background information independently gathered by the SAB Staff Office.
Selection criteria to be used for panel membership include: (a)
Scientific and/or technical expertise, knowledge, and experience
(primary factors); (b) availability and willingness to serve; (c)
absence of financial conflicts of interest; (d) absence of an
appearance of a loss of impartiality; (e) skills working in committees,
subcommittees and advisory panels; and (f) for the panel as a whole,
diversity of expertise and scientific points of view.
    The SAB Staff Office's evaluation of an absence of financial
conflicts of interest will include a review of the ``Confidential
Financial Disclosure Form for Environmental Protection Agency Special
Government Employees'' (EPA Form 3110-48). This confidential form is
required and allows government officials to determine whether there is
a statutory conflict between a person's public responsibilities (which
include membership on an EPA federal advisory committee) and private
interests and activities, or the appearance of a loss of impartiality,
as defined by federal regulation. The form may be viewed and downloaded
through the ``Ethics Requirements for Advisors'' link on the SAB
website at http://www.epa.gov/sab. This form should not be submitted as
part of a nomination.
    The approved policy under which the EPA SAB Office selects members
for subcommittees and review panels is described in the following
document: Overview of the Panel Formation Process at the Environmental
Protection Agency Science Advisory Board (EPA-SAB-EC-02-010), which is
posted on the SAB website at http://www.epa.gov/sab.

V Khanna Johnston,
Deputy Director, Science Advisory Board Staff Office.
[FR Doc. 2021-18807 Filed 8-31-21; 8:45 am]
BILLING CODE 6560-50-P


1 MITC Charge to the HSRB MITC Charge to the HSRB MITC is an irritating compound that has a limited animal database for toxicity via inhalation, the key route of exposure. MITC can be used as a pesticide directly to treat wood poles, but the major pathway of exposure to MITC is from degradation of several fumigant pesticides ( i. e., metam sodium,

metam potassium, and dazomet). Due to its volatility, MITC has the potential to move off site,

which can result in exposure to bystanders near treated areas and, through ambient air, to people far away from treated areas. Use of the soil fumigants also results in exposure to those handling the pesticides or working in treated fields. 2 MITC Charge to the HSRB MITC Charge to the HSRB 1. Scientific considerations The Agency's WOE document and DER for MITC describe the study design and results of the MITC odor threshold and eye irritation human studies. The WOE document also discusses the Agency's conclusions that the eye irritation study is useful for the assessment of potential effects on bystanders and workers from exposures to MITC during acute ( 1 day) intervals. 3 MITC Charge to the HSRB MITC Charge to the HSRB 1. Scientific considerations, cont'd The Agency has concluded that the odor threshold study is less useful than the eye irritation study for assessing the human health effects of MITC, since the odor detection threshold for humans is higher than the level that causes eye irritation. The Agency has decided, however, to use the results of the eye irritation study for assessing the inhalation exposure of MITC.

Please comment on the scientific evidence that supports this conclusion. 4 MITC Charge to the HSRB MITC Charge to the HSRB 2. Ethical considerations The Agency requests that the Board provide comment on the following:

a. Is there clear and convincing evidence that the conduct of the human eye irritation study with MITC was fundamentally unethical?

b. Is there clear and convincing evidence that the conduct of this study was significantly deficient relative to the ethical standards prevailing at the time the research was conducted?


[Federal Register Volume 77, Number 40 (Wednesday, February 29, 2012)]
[Notices]
[Page 12281]
[FR Doc No: 2012-4800]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14181-000; Project No. 14195-000]

Lock+ Hydro Friends Fund XLIII; FFP Project 53, LLC; Notice
Announcing Filing Priority for Preliminary Permit Applications

    On February 22, 2012, the Commission held a drawing to determine
priority among competing preliminary permit applications with identical
filing times. In the event that the Commission concludes that none of
the applicants' plans are better adapted than the others to develop,
conserve, and utilize in the public interest the water resources of the
region at issue, the priority established by this drawing will serve as
the tiebreaker. Based on the drawing, the order of priority is as
follows:
    1. Lock+ Hydro Friends Fund XLIII, Project No. 14181-000.
    2. FFP Project 53, LLC, Project No. 14195-000.

    Dated: February 22, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-4800 Filed 2-28-12; 8:45 am]
BILLING CODE 6717-01-P


          Sample of States with Container Documentation Requirements
                                     State
                              Regulatory Citation
Vermont
The inspection requirement is specified under section 7-311(d)(2).
Small and large quantity generators shall conduct daily inspections during regular business days of each short-term storage area. The inspections shall be recorded in a log that is kept at the facility for at least three years.
Nevada
NAC  444.8677    Written record of inspections by certain generators of hazardous waste.
A generator who generates more than 100 kilograms of hazardous waste in a calendar month and accumulates hazardous waste on-site shall, in addition to complying with the requirements for accumulation set forth in 40 C.F.R. § 262.34, maintain a written record of inspections conducted of containers and tanks. Those records must be kept on-site for not less than 3 years and must include:
     1.    The date and time of an inspection;
     2.    The name of the inspector;
     3.    A notation of the inspector's observations; and
     4.    The date and nature of any repairs made or other remedial action taken.
Massachusetts
30.542: Operating Record
(1) The owner or operator shall keep a written operating record at the premises of the facility, and it shall be readily accessible to personnel of the Department and the EPA.
(2) The following information shall be recorded, as it becomes available, and maintained in the operating record until closure of the facility, or for at least three years after the information is
recorded in the operating record of the facility, whichever period is longer:
(a) A description and the quantity of each hazardous waste received, and the method(s) and date(s) of its treatment, storage, use or disposal at the facility.
(b) The location of each hazardous waste type within the facility and the quantity at each location. For land disposal facilities, the location, quantity and EPA or Massachusetts hazardous waste number of each hazardous waste shall be recorded on a map or diagram of each cell or disposal area. For all facilities, this information shall include cross-references to specific manifest document numbers.
(c) Records and results of waste analyses required by 310 CMR 7.08(4), 30.513, 30.560 or 30.629, and 40 CFR 268.4(a) and 268.7 as incorporated by reference at 310 CMR 30.750 with modifications.
(d) Summary reports and details of all incidents that require implementing the contingency plan.
(e) Records and results of inspections as required by 310 CMR 30.515.
(f) For facilities which receive shipments of hazardous waste from off-site sources, notices to generators as required by 310 CMR 30.512.
Kansas
KSQG CONTAINER MANAGEMENT REQUIREMENTS
:: Each container must be in good condition.
:: Each container must be compatible with its contents.
:: Each container must be kept closed except when adding or removing waste.
:: Hazardous waste must not be stored near other hazardous wastes or materials with which it is incompatible.
:: Conduct monthly inspections of hazardous waste storage areas.
 At a minimum, the inspections should be documented in a log and should include the date and time of the inspection, the name of the inspector, a notation of the observations made, and the date and nature of any repairs or other remedial actions.
Florida
         1.  Containers (e.g. drums, cans, etc.) must be kept closed and in good condition, inspected at least weekly, be compatible with the HW stored, and separated from other incompatible wastes (e.g. keep cyanides away from acids) (265 Subpart I). Records must be kept of these inspections ( FAC 62-730.160).


[Federal Register Volume 81, Number 82 (Thursday, April 28, 2016)]
[Notices]
[Pages 25408-25409]
[FR Doc No: 2016-09951]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1842]

Compliance Policy Guide on Crabmeat--Fresh and Frozen--
Adulteration With Filth, Involving the Presence of Escherichia coli

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a Compliance Policy Guide (CPG) relating to fresh and
frozen crabmeat adulteration with filth involving the presence of
Escherichia coli (E. coli). The CPG updates the previously issued CPG
on this topic. The CPG provides guidance for FDA staff on the level of
E. coli in crabmeat at which we may consider the crabmeat to be
adulterated with filth.

DATES: Submit electronic or written comments on FDA's CPGs at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-D-1842 for ``Compliance Policy Guide on Crabmeat--Fresh and
Frozen--Adulteration with Filth, Involving the Presence of Escherichia
coli.'' Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
http://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to Office
of Policy and Risk Management, Office of Regulatory Affairs, Office of
Global Regulatory Operations and Policy, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD 20857. Send two self-addressed
adhesive labels to assist that office in processing your request. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance.

FOR FURTHER INFORMATION CONTACT:  Mary E. Losikoff, Center for Food
Safety and Applied Nutrition (HFC-820), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of revised CPG Sec. 540.275
Crabmeat--Fresh and Frozen--Adulteration with Filth, Involving the
Presence of Escherichia coli. The CPG updates the previously issued CPG
Sec. 540.275 Crabmeat--Fresh and Frozen--Adulteration with Filth,
Involving the Presence of Escherichia coli. We are issuing this CPG
consistent with our good guidance practices regulation (21 CFR 10.115).
The CPG represents the current thinking of FDA on this topic. It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.
    The CPG provides guidance for FDA staff on the level of E. coli in
fresh or frozen crabmeat (i.e., 3.6 Most Probable Number per gram (MPN/
g) of E. coli) at which FDA may consider the crabmeat to be adulterated
with filth under section 402(a)(4) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 342(a)(4)). We revised the CPG for clarity and
to update the format. Revisions generally include the addition of
sections on Background and Policy, updates to the sections on
Regulatory Action Guidance and Specimen Charges, and FDA office names.
The CPG provides criteria that the FDA District Offices may use to
determine whether to recommend an enforcement action. Consistent with
our standard business process, the CPG provides guidance to the FDA
field offices for submitting an enforcement action recommendation to
FDA's Center for Food Safety and Applied Nutrition (CFSAN) for case
review. The CPG also provides direct reference authority to the FDA
field offices in certain situations. Rather than submitting the
recommendation to CFSAN, direct reference authority allows the FDA
field offices to submit the recommendation directly to the appropriate
office in FDA's Office of Regulatory Affairs, thus streamlining the
Agency's internal case review process. Specifically, in the section on
Regulatory Action Guidance, we clarify that FDA's District Offices have
direct reference authority for both domestic seizure and import refusal
based on the criteria described in the CPG. We also clarify the
specific types of legal action to which the criteria for
recommendations apply. In addition, we provide specimen charges
relating to domestic seizure and import refusal. The CPG also contains
information that may be useful to the regulated industry and to the
public.
    In the Federal Register of December 16, 2014 (79 FR 74729), we made
available draft CPG Sec. 540.275 ``Crabmeat--Fresh and Frozen--
Adulteration with Filth, Involving the Presence of Escherichia coli.''
We gave interested parties an opportunity to submit comments on the
draft CPG by February 17, 2015, for us to consider before beginning
work on the final version of the CPG. We received no comments on the
draft CPG. We are issuing the CPG with no changes other than for
clarity and to update the format. The CPG announced in this notice
finalizes the draft CPG dated December 2014.

II. Electronic Access

    Persons with access to the Internet may obtain the CPG at either
http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm or http://www.regulations.gov. Use the FDA Web site listed in the previous
sentence to find the most current version of the CPG.

    Dated: April 25, 2016.
Katherine Bent,
Assistant Commissioner for Compliance Policy.
[FR Doc. 2016-09951 Filed 4-27-16; 8:45 am]
 BILLING CODE 4164-01-P