                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            REGION IX AIR DIVISION

                          Technical Support Document
                                      for
                              EPA's Rulemaking
                                    for the
                       Arizona State Implementation Plan

           Agricultural Best Management Practices Definitions Rules
                    Agricultural PM10 General Permits Rules
                    Appendix 2. Test Methods and Protocols

                               December 19, 2016

RULE IDENTIFICATION
Agency
Arizona Department of Environmental Quality (ADEQ)

SIP-Approved Rules
Arizona Administrative Code (AAC) R18-2-610, "Definitions for R18-2-611"; and
AAC R18-2-611, "Agricultural PM10 General Permit: Maricopa PM10 Nonattainment Area"
Effective: May 12, 2000.
Submitted: July 11, 2000.
EPA Approved: October 11, 2001 (66 FR 51869).

Appendix 2, Test Methods and Protocols
Effective: October 3, 2005.
Submitted: July 28, 2011.
EPA Approved: September 23, 2014 (79 FR 56655).
Subject of this TSD
AAC R18-2-610, "Definitions for R18-2-610.01, R18-2-610.02, and R18-2-610.03";
AAC R18-2-610.3, "Agricultural PM General Permit for Crop Operations; Pinal County PM Nonattainment Area";
AAC R18-2-612, "Definitions for R18-2-612.01";
AAC R18-2-612.01, "Agricultural PM General Permit for Irrigation Districts; PM Nonattainment Areas Designated After June 1, 2009"; and
AAC Appendix 2, "Test Methods and Protocols."

Effective: July 2, 2015
Submitted: December 21, 2015
Completeness Finding
Determination of completeness letter: March 21, 2016

BACKGROUND

The current SIP-approved versions of AAC 18-2-610, "Definitions for R18-2-611" and AAC R18-2-611, "Agricultural PM10 General Permit: Maricopa PM10 Nonattainment Area," established definitions of Agricultural Best Management Practices (AgBMPs) and an agricultural general permit rule for the Maricopa PM10 Nonattainment Area. ADEQ's December 21, 2015 submittal includes new rule AAC R18-2-610, "Definitions for R18-2-610.01, R18-2-610.02, and R18-2-610.03." This new rule does not supersede AAC 18-2-610 "Definitions for R18-2-611," which remains in the SIP. If the new rule is approved, there will be two rules in the SIP with the same number but different titles.

The Arizona AgBMP program includes an AgBMP Committee, as established in Arizona Revised Statute (ARS) 49-457, and agricultural general permit (general permit) rules adopted by the AgBMP Committee, specifying best management practices for regulated agricultural activities to reduce PM10 emissions.

The rules adopted by the AgBMP Committee to date apply to three categories of agricultural operations: Commercial Farms (Crops), Animal Operations, and Irrigation Districts. In each category, the Committee has adopted a "definitions" rule and "general permit" rules.

ADEQ submitted to the EPA for SIP approval only the AgBMP general permit rules for the West Pinal nonattainment area and the definitions rules that apply these general permit rules. The submitted definitions rules also apply to general permit rules that were not submitted by ADEQ, including those for the "Maricopa County PM Nonattainment Areas," "Moderate PM Nonattainment Areas designated after June 1, 2009, except Pinal County PM Nonattainment Area," and the "Yuma PM10 Nonattainment Area."

Collectively, we refer to the submitted rules evaluated in this TSD as "AgBMP" rules.

The previous SIP-approved version of "Appendix 2. Test Methods and Protocols" included test methods and protocols approved by the ADEQ and incorporated by reference as applicable requirements. The submitted revision to Appendix 2 adds test methods.

On May 6, 2010, ADEQ submitted amended rules AAC R18-2-610. "Definitions for R18-2-611" and AAC R18-2-611. "Agricultural PM10 General Permit; Maricopa PM10 Nonattainment Area and Maricopa County Portion of Area A." On September 9, 2010, EPA proposed a simultaneous limited approval and limited disapproval of these rules because they strengthened the SIP but they did not fully meet the CAA requirements for enforceable Best Available Control Measures (BACM) in the Maricopa NAA. ADEQ withdrew the amended rules on April 26, 2014.

In this TSD, we discuss a subset of the rules that ADEQ submitted to EPA on December 21, 2015. They are as follows: AAC R18-2-610. "Definitions for R18-2-610.01, R18-2-610.02, and R18-2-610.03"; AAC R18-2-610.3, "Agricultural PM General Permit for Crop Operations; Pinal County PM Nonattainment Area"; AAC R18-2-612, "Definitions for R18-2-612.01";
AAC R18-2-612.01, "Agricultural PM General Permit for Irrigation Districts; PM Nonattainment Areas Designated After June 1, 2009"; and AAC Appendix 2, "Test Methods and Protocols."

RULE SUMMARY

R18-2-610, Definitions for R18-2-610.01, R18-2-610.02, and R18-2-610.03  -  ADEQ submitted this new rule to EPA for SIP approval. New rule R18-2-610 provides definitions for general permit rules R18-2-610.01, R18-2-610.02, and R18-2-610.03. Of those general permit rules, the ADEQ has, in this submittal, included only R18-2-610.03, "Agricultural PM General Permit for Crop Operations: Pinal County PM Nonattainment Area" for SIP approval.

New rule R18-2-610 contains 65 definitions, including 29 AgBMP definitions. AgBMP definitions in new rule R18-2-610 include specific standards or testing requirements that the commercial farmer (farmer) must meet when implementing an AgBMP selected for compliance with the general permit rule. For example, the AgBMP definition of "conservation tillage" is "a tillage system that reduces a minimum of three tillage operations. This system reduces soil and water loss by planting into existing plant stubble on the fields after harvest as well as managing the stubble to that it remains intact during the planting season." See R18-2-610(13). "Cover crop" is defined as "establishing cover crops that maintain a minimum of 60 percent ground cover...Compliance shall be determined by the Line Transect Test Method, NRCS National Agronomy Manual, Subpart 503.51, Estimating Crop Residue Cover, amended through February 2011 (and no future editions)." See R18-2-610(14). The rule defines "tillage operation" as "an agricultural operation that mechanically manipulates the soil for the enhancement of crop production. Examples include discing or bedding. A pass through the field may be a subset of a tillage operation." See R18-2-610(58).

R18-2-610.03, Agricultural PM General Permit for Crop Operations: Pinal County PM Nonattainment area  -  This new rule requires a commercial farmer ("farmer") to complete a BMP Program General Permit Record Form (BMP Form), demonstrating compliance with the rule and specifying the BMPs selected for tillage, ground operations and harvest, cropland, noncropland, commercial farm roads, and significant earth moving activities, and any BMPs selected for "high risk" days, as predicted by the Pinal County Dust Control Forecast (section C). The rule creates six categories of BMPs: B.1. Tillage; B.2. Ground Operations and Harvest; B.3. Noncropland; B.4. Commercial Farm Roads; B.5. Cropland; and, B.6. Significant Agricultural Earth Moving Activities. Each category contains six to twelve BMP options.

This rule requires a farmer who engages in a regulated agricultural activity (as defined in R18-2-610(45)) to implement at least one BMP from each of the Tillage, Ground Operations and Harvest, Noncropland, Commercial Farm Roads, and Significant Agricultural Earth Moving Activities categories. The farmer must implement two BMPs in the Cropland category. See section B.

As required by Section A of Rule R18-2-610.03, farmers must ensure implementation of BMPs as described in sections B.1(b), B.2(b), B.3(b), B.4(b) and B.5 (b) on the day before and during the day that is forecast to be high risk for dust generation (see R18-2-610(18)).

Described in sections C, D, E, F, G, and K, the administrative requirements of R18-2-610.03 include the following:

 From and after December 31, 2015, a farmer who engages in a regulated agricultural activity must complete a BMP Form. Thereafter, the farmer must complete a new BMP Form every year by March 31. The BMP Form must be provided to the Director within two business days of notice to the farmer. The BMP Form must include the name of the farmer, signature and date signed; the mailing or physical address of the farm; the BMPs selected for tillage, ground operations and harvest, cropland, noncropland, commercial farm roads, and significant earth moving activities. It must also include any additional BMPs selected for high risk days, as predicted by the Pinal County Dust Control Forecast. See section C.

 Beginning in 2017, and no more than once every subsequent three years, the ADEQ must provide the farmer with a BMP Program 3-year Survey. The farmer must complete the Survey with data from the prior year, and submit it to the Arizona Department of Agriculture (ADA) by January 31, 2018, and every three years thereafter. The ADA will compile the data in a way that does not refer to the operator's name, and send the aggregated data to the Department.   On the survey, the farmer must provide the name, business address, and phone number of the person responsible for the preparation and implementation of the BMPs, the signature of the farmer and date the form was signed, the acreage of each crop type planted or growing; the total miles of farm roads; the total acreage of noncropland; and the BMPs (for all days and for high risk days) selected for the farm. See section D.

 The farmer is required to record changes to the BMPs on the BMP Form and to keep the form onsite and available to the Director within two business days of notice. See section E.

 New BMPs can be developed and submitted to the Committee if they are proven effective through on-farm demonstration trials to the Committee. They will not become effective unless submitted to EPA for SIP approval, per ARS 49-457(L). See section F.

 The farmer must keep a record demonstrating compliance with the rule for three years, including a copy of the complete BMP Form to confirm implementation of each BMP. See section G.

 A farmer who is not in compliance with the rule is subject to provisions in ARS 49-457(I), (J) and (K). See section K.

R18-2-612 Definitions for R18-2-612.01 -  ADEQ submitted this new rule for SIP-approval that provides 33 definitions for new rule R18-2-612.01.

R18-2-612.01 Agricultural PM General Permit for Irrigation Districts; PM Nonattainment Areas Designated After June 1, 2009  -  ADEQ submitted this new rule for SIP approval. It requires an irrigation district within a PM nonattainment area to implement at least one BMP from each specified category to reduce PM emissions. The rule divides BMPs into three categories: 1. "Unpaved operation and maintenance roads" (13 BMP options), 2. "Canals" (five BMP options) and 3. "Unpaved utility access roads" (13 BMP options). Some of the BMPs are similar to those listed for unpaved roads and unpaved access areas in Rule 18-2-610, such as "Access restriction," "Apply and maintain aggregate cover," "Install and maintain a track-out control system," and "Apply and maintain synthetic particulate suppressant." However, BMPs specific to the irrigation district have been added, including "Apply and maintain water before, during and after major and minor earth moving activities," "dredge canals while muck or debris is still wet," and "weed management." For irrigation districts, the "Reduce vehicle speed" BMP sets a maximum speed of 25 mph, whereas, the "Reduce vehicle speed" BMP for farming operations is 15 mph.

The administrative provisions of Rule R18-2-612.01 require the following actions:

 From and after December 31, 2015, an irrigation district engaged in a regulated agricultural activity must complete a BMP Form. After that, the operator must complete a new BMP Form by March 31 every year. The BMP Form must be provided to the Director within two business days of notice to the irrigation district. The BMP Form must include the name, business address of the irrigation district representative responsible for the preparation and implementation of the BMPs; the signature of this representative and the date the form was signed; and the BMPs selected for unpaved operation and utility roads, canals, and unpaved utility access roads. See section B.

 Beginning in 2017, and no more than once every subsequent three years, the Director, in conjunction with the ADA, must provide the irrigation district with a BMP Program 3-year Survey. The irrigation district must complete the survey with data from the prior year and submit it to the ADA by January 31, 2018, and every three years thereafter. The ADA must compile the submitted survey data and submit it to the Department. In the survey, the operator must provide the name, business address, and phone number of the irrigation district representative responsible for the preparation and implementation of the BMPs, the signature of the irrigation district representative and date the form was signed, the total miles of canals that the irrigation district controls; the total miles of unpaved operation and maintenance roads; the total miles of the unpaved utility access roads; and the BMPs selected for unpaved operation and utility roads, canals, and unpaved utility access roads.

 Records of changes to the selected BMPs must be written on the BMP Form, kept onsite by the irrigation district representative, and must be kept on site and made available for review by the Director within two business days of notice. The irrigation must keep records demonstrating compliance with the rule for three years. Records include a copy of the BMP Form to confirm implementation of each BMP. See sections D and F.

 An irrigation district may develop different practices not included in subsections (A)(1), (A)(2), or (A)(3) and may submit practices that are proven effective through in-district trials. They will not become effective unless submitted to EPA for SIP approval (per ARS 49-457(L)). See section E.

 An irrigation district that is not in compliance with the rule is subject to provisions in ARS 49-457(I), (J), and (K). See section J.

These administrative provisions are analogous to those found in Rule R18-2-610.03.

Appendix 2. Test Methods and Protocols ("Appendix 2")  -  ADEQ submitted for SIP-approval a revision of SIP-approved Appendix 2 to relabel section numbers (1 through 11) to letters (A through K) and to add sections L and M. As confirmed by ADEQ, Section L's reference to 40 CFR 51.128 is a typographical error; the intended reference is to 40 CFR 52.128. The Silt Content Test Method, as described in new section M, is used to estimate the silt content of trafficked parts of commercial farm roads. Vehicle traffic on roads with higher silt content release greater levels of fine dust particles.

EVALUATION CRITERIA

The following criteria were used to evaluate the submitted rules.

1.	Enforceability - The Bluebook (Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations, EPA, May 25, 1988) and the Little Bluebook (Guidance Document for Correcting Common VOC & Other Rule Deficiencies, EPA Region 9, August 21, 2001) were used to help evaluate compliance with the CAA §110(a)(2)(A) requirement for enforceability in control measures and other SIP limitations.

2.	Stringency  -  Nonattainment areas are required to demonstrate reasonably available control measures (RACM). CAA Section 172(c)(1) requires that each attainment plan "provide for the implementation of all reasonably available control measures as expeditiously as practicable (including such reductions in emissions from existing sources in the area as may be obtained through the adoption, at a minimum, of reasonably available control technology), and shall provide for the attainment of the national primary ambient air quality standards." RACM findings are generally made in context of an overall attainment demonstration. Our stringency evaluation includes primarily a comparison of these AgBMP provisions with existing Arizona SIP provisions and other state's rules that apply to similar sources.

3.	SIP Relaxation - CAA §110(l) prohibits EPA from approving any SIP revision that would interfere with any applicable requirement concerning attainment and reasonable further progress (RFP) or any other applicable requirement of the CAA. In addition, CAA §193 prohibits the modification of any SIP-approved control requirement in effect before November 15, 1990, in a nonattainment area.

EPA EVALUATION

A summary of our evaluation of the three criteria follows.

1. 	Enforceability Evaluation - To help ensure enforceability, the rule requirements and applicability are clear, and the recordkeeping, reporting and other provisions sufficiently ensure that affected sources and regulators can evaluate and determine compliance with AgBMP rules consistently and with replicable result.

The definition rules R18-2-610 and R18-2-612 contain BMP and related definitions that are clear and specific for the implementation of the source-specific General Permit Rules R18-2-610.03 and R18-2-612.01, respectively.

Examples in R18-2-610 include:
 "Combining tractor operations" means reducing soil compaction and a minimum of one tillage or ground operation across a commercial farm using a tractor, implement, harvester, or other farming support vehicle to perform two or more tillage, cultivation, planting, or harvesting operations at the same time. If "Equipment modification" is also chosen as a BMP, and uses the same practices as described in this BMP, this action is considered one BMP.
 "Cover Crop" means establishing cover crops that maintain a minimum of 60 percent ground cover...Compliance shall be determined by the Line Transect Test Method, NRCS National Agronomy Manual, Subpart 502.51, Estimating Crop Residue Cover, amended through February 2011 (and no future editions).
 "Conservation Tillage" means a tillage system that reduces a minimum of three tillage operations. This system reduces soil and water loss by planting into existing plant stubble on the field after harvest as well as managing stubble so that it remains intake during the planting season.
 "Fallow Field" means an area of land that is routinely cultivated, planted and harvested and is unplanted for one or more growing seasons or planting cycles, but is intended to be placed back in agricultural production.
 "Harvest" means the time after planting up through harvest, including gathering mature crops from a commercial farm, as well as all actions taken immediately after crop removal, such as cooling, sorting, cleaning, and packing."
 "Limited tillage activity means performing no tillage operations on a day identified by the Maricopa or Pinal County Dust Control Forecast to be high risk for dust generation."

Examples in R18-2-612 include:
 "Apply and maintain synthetic or natural particulate suppressant" means reducing PM emissions and wind erosion by providing a stabilized soil surface with organic material, such as muck, animal waste or biosolids, or with a manufactured product such as lignosulfate, calcium chloride, magnesium chloride, and emulsion of a petroleum product, an enzyme product, or polyacrylamide.
 "Dredge canals" means reducing PM emissions by mechanically removing much, debris, and other foreign objects from canals while material is still wet or damp.
 "Minor earth moving activities" means the mechanical movement of earth materials to repair and maintain the existing configuration, location, bank slopes, or inclines of canals.

Rules R18-2-610.03 and R18-2-612.01 contain administrative requirements for farmers, operators, and irrigation districts. These requirements are clear, specific and include compliance dates, are similar for all operators, and include the annual obligation to complete a BMP Form demonstrating compliance with the rules, and the requirement to make the form available to the State within two days of notice. Every three years, starting in 2017, farmers, operators, and irrigation districts are required to complete and submit to the State a survey that includes the BMPs implemented the prior year, the acreage and/or mileage to which BMPs were applied, and the name, address, phone number and signature of the farmer, operator or responsible party. Records demonstrating compliance with the rules must be kept for three years.

Appendix 2. Test Methods and Protocols section L adds the surface stabilization test method "Silt Content" from Appendix A(1)(B) of 40 CFR 52.128. Section M, "Silt Content Test Method," has the same requirements as the SIP-approved Silt Content Test Method for Maricopa County (See Maricopa County Air Pollution Control Regulations, Appendix C, Fugitive Dust Test Methods (section 2.1.2), amended March 26, 2008, approved by EPA on December 15, 2010 (72 FR 46564).

2. 	Stringency Evaluation  -  We are evaluating whether the AgBMP rules apply requirements consistent with other state's rules.

Since 2001, other air quality districts have adopted rules for agricultural (crop) and unpaved irrigation road sources of PM. For example, EPA has approved the following rules into the SIP:
 San Joaquin Valley Air Pollution Control District (SJVUAPCD or SJV) Rule 4550, Conservation Management Practices (CMPs), and List of Conservation Management Practices, 71 FR 7683, February 14, 2006.
 Imperial County APCD (ICAPCD) Rule 806 Conservation Management Practices (CMPs), 78 FR 23677, April 22, 2013. ICAPCD Rule 800, General Requirements for Control of Fine Particulate Matter, and Rule 805, Paved and Unpaved Roads 78 FR 23677, April 22, 2013.
 SJV Rule 8061 Paved and Unpaved Roads, Rule 8081 Agricultural Sources, and Rule 8011 General Requirements, 71 FR 8461, February 17, 2006.
 South Coast Air Quality Management (SCAQMD) Rule 403 Fugitive Dust, 73 FR 12639, March 10, 2008.
SJV Rules 4550, 8011, 8061 and 8081; ICAPCD Rules 800, 805, and 806 and SCAQMD Rule 403 were previously approved as satisfying the BACM requirements for the control of PM10.

      R18-2-610 (Crop Definitions) and R18-2-610.3 (Pinal Crops):

The Pinal Crops rule, SJV Rule 4550 and ICAPCD Rule 806 are menu-based rules. As such, they allow the farmer the flexibility to choose among a number of control measure options for each BMP (or CMP) category. Table 1 provides a general comparison of these rules. The Pinal Crops rule regulates farms with 10 or more contiguous acres, while Imperial Rule 806 and SJV Rule 4550 apply to farms of 40 and 100 or more acres, respectively. The Arizona AgBMP rules generally regulate the same activities (tillage, harvest/ground operations, unpaved farm roads and noncropland (includes equipment areas)) on commercial farms as the SJV and Imperial CMP rules. The submitted Pinal Crops rule and the Imperial Rule 806 include mandatory windblown dust controls and offer an incentive to use conservation tillage. The submitted Crop Definitions rule and Imperial Rule 806 include detailed BMP (or CMP) definitions for BMP (or CMP) implementation, whereas SJV Rule 4550 requires farmers to submit a CMP plan with CMP implementation details. The Arizona AgBMP rules require farmers to complete and submit a survey of BMP practices to the Arizona Department of Agriculture every three years. The SJVUAPCD rule requires each farmer to submit a CMP Plan to the APCD.

Table 1: Crop Operations
AAC R18-2-610 and 610.03
Imperial Rule 806
SJV Rule 4550
Applicability  -  farm size
10+ acres [610 (9)]
40+ acres [D.1]
100+ acres [2.0 and 4.1.1]
Control measures
Implement at least one BMP per category, and two from section B(5)(a). [610.03 (A) and (B)]. BMPs defined in 610.
Implement at least one CMP per category [D.1]
Implement at least one CMP per category [5.0 and 6.2], CMP List
Crop BMP categories
Tillage, Ground operations and harvest; Cropland [610.03 (B) (1), (2), (5)]
Land preparation-cultivation; Harvest activities; Cropland-other; Windblown dust control
Cropland- Land preparation/cultivation; Cropland-harvest; Cropland-other [CMP List]
Noncropland, Unpaved road/area, significant earth moving BMP categories
Noncropland, Commercial Farm Roads (with additional requirement for > 20 VDT 2+axle vehicles);
Significant Agricultural Earth moving Activities [610.03 (B)(3), (4), (6)]
Unpaved roads, Unpaved Traffic Areas.
Stabilization and opacity requirements for >50 VDT or > 20 VDT (3 axel).[D.3, E.3]
Cropland-Unpaved roads; Cropland- Unpaved vehicle/equipment traffic areas. [CMP List]

Mandatory Windblown Dust Controls
Yes [610.03 (A) and (B)]
Yes. [D and E]
No
Conservation Tillage incentive
Yes [610.03 (B)]
Yes. [section D.1]
No
Recordkeeping
BMP recordkeeping form (name, address, signature, BMPs selected for each category, any additional BMPs selected for high risk days)) and records of changes to BMPs. Make available to APCD upon request within 2 days. [610.03 (C) and (E)]
CMP Plan including total acreage, total miles unpaved roads, total area of traffic areas covered by CMP Plan. Description of CMPs implemented consistent with definitions. Supporting documentation necessary to confirm implementation of CMPs. Technical evaluation for alternative CMPs and documentation of APCD approval. Available to APCD upon request. [F and H]

Upon request, make available to APCO a copy of each CMP Application and CMP Plan, supporting information necessary to confirm implementation of CMPs, and documented qualified exemption claim. [6.5]
Record retention
3 years [610.03 (G)]
2 years [H]
5 years [6.5]
Reporting
Beginning 2017 and no more than once every subsequent 3 years, submit survey form with specific information on BMPs used (e.g., acres and miles, BMPs selected) to Arizona Department of Agriculture (ADA) [610.03 (D)]
None
Submit to APCO for review, evaluation, and approval: CMP Application and CMP Plan, including map (location of each ag parcel, of unpaved roads and equipment areas covered by CMP Plan, where CMP will be implemented); For each parcel - CMPs selected, crop, AFO or other agricultural use of parcel. Information needed to calculate emission reductions (e.g., crop acreage, # animals, miles of roads, area of equipment/traffic areas covered by Plan.) [6.1]

Alternative measures
A person may develop different practices to control PM emissions not contained in sections 610.03 (B)(1)  -  (B)(6) and may submit such practices that are proven effective through on-farm demonstration trials to the AgBMP Committee. Proposed new practices will not become effective unless submitted to EPA for SIP approval. [610.03(F)]
Owner/operator must submit technical evaluation of alternative CMPs to APCD, demonstrate emission reductions at least equivalent to other CMPs for that operation. APCD must approve alternative CMP before it can be included in Plan. [D.6]
An owner/operator may select a substitute CMP from another CMP category when no feasible CMP can be identified from one category. Not applicable for unpaved road and unpaved vehicle/equipment traffic area CMP categories. Must obtain interim approval of APCO before using. The owner/operator must demonstrate new CMP achieves PM10 emission reductions at least equivalent to other CMPs on list that could be selected for the applicable operation. [6.2.3]

      R18-2-612 and 18-2-612.01, Irrigation District rules:

Rules R18-2-612 and 18-2-612.01 are specific to unpaved roads, unpaved utility access roads, and canals within irrigation districts. ICAPCD Rule 805 applies to canals and canal roads. We were not able to find a direct comparison in the SJVUAPCD rules; however, we believe that SJV Rule 8061 would apply to unpaved irrigation/canal roads and areas.

Table 3  -  Irrigation Districts
AAC R18-2 612 and 612.01
Imperial Rule 805
SJV Rule 8061/8011
Applicability
Irrigation District (ID) within a PM Nonattainment Area, designated after June 1, 2009. [612.01 (A)]
Any new or existing public of private paved or unpaved road, road construction project, or road modification project.
Any unpaved road segment with 26 or more annual average daily traffic. [2.0 and 4.0]

Control Requirements
Implement at least one BMP per category.
[612.01 (A)]. BMPs defined in 612.
For canal roads with 20+ Average Vehicle Trips /day, implement at least one control measure in F.1 Unpaved Roads, including unpaved haul and access roads; comply with requirements of "Stabilized Unpaved Road" [Rule 800 C.38] and limit visible dust emissions (VDE) to 20% opacity (per 800 Appendix B, section C), and implement other measures in F.2 Canal Roads.[E.4]
Limit VDE to 20% opacity and comply with the requirements of a stabilized unpaved road by application/maintenance of at least one specified control measure, or implement an APCO-approved Fugitive PM10 Management Plan as specified in Rule 8011. [5.2.1]. Limit vehicle speeds to 25 mph. [5.2.5]

BMP categories
Unpaved operation and maintenance roads; Canals; Unpaved utility access roads. [612.01 (A)]
Unpaved roads (includes Haul and Access Roads); Canal Roads.
N/A
Recordkeeping
BMP recordkeeping form (name, business address of ID representative responsible for BMPs, signature, date form signed, BMPs selected for each category, any changes to the BMPs. Make available to irrigation district upon request within 2 days. [612.01 (B) and (D)]
Compile and maintain records that provide evidence of control measure application. Provide to APCD upon request. [G]
Control measure(s) used, location, extent of coverage, date, etc. Recordkeeping requirements for Rule 8011 apply [6.2]

Record retention
Minimum 3 years [612.01 (F)]
Minimum 2 years [G]
Recordkeeping requirements for Rule 8011 apply [6.2]
Reporting
Beginning 2017 and no more than once every subsequent 3 years, submit survey form with specific information on BMPs used (e.g., total miles or canals, unpaved areas, BMPs selected) to ADA [612.01 (C)]
None
Prepare and submit a written report to the District documenting
compliance with the rule
no less frequently than every 2 years. Include total miles of roads, and summary of action. [6.2]

Alternative measures
An ID may develop different practices not contained in 612.01 (A)(1), (A)(2), or (A)(3) that reduce PM and may submit such practices proven effective through in-district trials. Proposed new practices will not become effective unless submitted to EPA for SIP approval. [612.01 (E)]
Any other method that effectively limits VDE to 20% opacity and meets the conditions of a Stabilized Unpaved Road. [F.1.g]
Any other method that can be demonstrated to satisfaction of APCD that effectively limits VDE to 20% opacity and meets the conditions of a stabilized unpaved road. [<IP_ADDRESS>]

Summary of stringency evaluation: A comparison of the AgBMP rules with the SJVUAPCD and Imperial CMP rules shows that the AgBMP rules are more stringent in some aspects. For example, Rule R18-2-610.03 has a lower applicability threshold than the other areas (at least 10 acres compared to 40 or 100 acres for the CMP rules). Rule 18-2-610.03, unlike SJV Rule 4550, provides an incentive to implement conservation tillage, which has been shown to be highly effective at controlling PM10, and has mandatory windblown dust requirements. Rule 18-2-610.03, unlike the other rules, includes implementation of at least one BMP for significant earth moving activities (Section B.6). In other respects, the AgBMP rules are less stringent. For example, SJV Rule 4550 requires operators to submit, for district approval, a CMP plan with details of CMP implementation, while the AgBMP rules require farmers to respond to a survey every three years. The AgBMP rules do not require, as do the Imperial and SJV rules, a 20% opacity limit and stabilization tests for high traffic roads and areas. We note that EPA has approved SJV Rule 4550 and Imperial Rule 806 as satisfying BACM/BACT.

In addition to those listed in the tables above, there are other district rules that apply to agricultural sources. They include SCAQMD rules such as Rule 403 Fugitive Dust. SCAQMD Rule 403 exempts crop operations as long as they follow the control measures in the Agricultural Handbook for the area. These handbooks contain similar types of controls as the AgBMP rules, but are more stringent in some aspects and less in other aspects. SJV Rule 8081, applies to off-field agricultural sources, and includes stabilization and 20% opacity requirements, which appears to be more stringent than the AgBMP rules. We note that EPA has approved SCAQMD Rules 403, and SJV Rule 8081 as satisfying BACM/BACT.

3.	SIP Relaxation evaluation: The submitted AgBMP rules and rule revisions are more stringent than the State's previously adopted SIP-approved versions of these rules (October 11, 2001, 66 FR 51872) because the new rules and revisions have set standards for compliance with commercial farming BMPs (e.g., reducing at least one tilling operation or ground operation, establishing a minimum percentage or depth of ground cover), there are added regulations irrigation districts, and the rules apply to a larger geographic area. We propose to determine that our approval of the submitted rules and rule revisions that are the subject of this TSD would comply with CAA §§110(l) and 193 because (1) the proposed SIP revision would not interfere with the on-going process for ensuring that requirements for RFP and attainment of the NAAQS are met, and (2) the emission standards in the submitted rules are more stringent than the existing SIP-approved control requirements that they would replace.

ADDITIONAL RECOMMENDATIONS FOR THE NEXT RULE REVISION - The following revisions are not currently the basis for rule disapproval, but are recommended for the next time the rule is amended.

 We recommend adding stabilization and 20% opacity requirements for high traffic unpaved roads/feed lanes and equipment/traffic areas, and adopting appropriate stabilization and opacity test methods.
 R18-2-610.03(C) and R18-2-612.01(B): These sections state that the BMP Forms must be provided to the Director within two business days of notice. We recommend that the rule include a provision that states that the BMP Forms must be provided to an inspector upon request.
 R18-2-610(19): The Crop BMP definitions specify an associated reduction in activity (e.g., reduce one tillage operation), but this language is lacking in the Equipment Modification BMP. Please consider specifying in the Equipment Modification BMP definition the minimum amount of tillage or ground/harvest operations reduced. In addition, we recommend that the farmer be required to describe on the BMP Form and Survey the type of equipment and how it was modified to reduce PM10 emissions.
 R18-2-610(54); and R18-2-612(27): We recommend that the rules define the term "stabilized soil surface."
 R18-2-610.03; R18-2-612.01; We recommend that the rules require that records be maintained for five years instead of three.
 R18-2-610, R18-2-612: We recommend that the rules define the term "Director" and "Department."
 R18-2-610(45): Please correct the cross-reference to ARS 49-457.
 The title of R18-2-610.03 is inconsistent on pages GVI-8 and GVI-16. Page GVI-8 uses the title, "Agricultural PM General Permit for Commercial Farms; Pinal County PM Nonattainment Area;" the title on page GVI-16 is "Agricultural PM General Permit for Crop Operations: Pinal County PM Nonattainment Area." Please revise for consistency.
 The title of R18-2-612.01 is inconsistent on pages GVI-8 and GVI-37. Please revise for consistency.

EPA ACTION

The following submitted rules are enforceable, strengthen the SIP by adding new control measures or revising and improving existing requirements, and fulfil the relevant CAA section 110 requirements for nonattainment areas:
AAC R18-2-610 Definitions for R18-2-610.01, R18-2-610.02, and R18-2-610.03;
AAC R18-2-610.3 Agricultural PM General Permit for Crop Operations: Pinal County PM Nonattainment Area;
ACC R18-2-612 Definitions for R18-2-612.01;
ACC R18-2-612.01 Agricultural PM General Permit for Irrigation Districts; PM Nonattainment Areas Designated After June 1, 2009;
Appendix 2. Test Methods and Protocols. Therefore, EPA staff recommends approval of these rules pursuant to CAA §110(k)(3) and §301(a).

REFERENCES

 "Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations," (a.k.a., Bluebook) EPA OAQPS, May 25, 1988.
 "Guidance Document for Correcting Common VOC & Other Rule Deficiencies," (a.k.a., Little Bluebook), EPA Region 9, August 21, 2001.
 "Rule 4550  -  Conservation Management Practices," SJVUAPCD, August 19, 2004. Approved 71 FR 7683, February 14, 2006.
  "Rule 8081  -  Agricultural Sources, September 16, 2004. Approved 71 FR 8461, February 17, 2006.
  "Rule 8061  -  Paved and Unpaved Roads," SJVUAPCD, August 19, 2004. Approved 71 FR 8461, February 17, 2006.
 "Rule 8011  -  General Requirements," SJVUAPCD, August 19, 2004. Approved 71 FR 8461, February 17, 2006.
 "Rule 806  -  Conservation Management Practices," ICAPCD, October 16, 2012. Approved 78 FR 23677, April 22, 2013.
 "Rule 805  -  Paved and Unpaved Roads," SJVUAPCD, October 16, 2012. Approved 78 FR 23677, April 22, 2013.
 "Rule 800  -  General Requirements for Control of Fine Particulate Matter," ICAPCD, October 16, 2012. Approved 78 FR 23677, April 22, 2013.
  "Rule 420  -  Beef Feedlots," ICAPCD, August 13, 2002. Approved 68 FR 8839, February 23, 2003.
 "Rule 403  -  Fugitive Dust," SCAQMD, June 3, 2005. Approved 73 FR 12639, March 10, 2008.
 "Rule 403 Coachella Valley Agricultural Handbook, Measures to Reduce Dust from Agricultural Operations in the Coachella Valley, SCAQMD, April 2004
 Rule 403 Agricultural Handbook, Measures to Reduce Dust from Agricultural Operations in the South Coast Air Basin, SCAQMD, December 1988.
 April 8, 2016 email correspondence between H. Haggerty, ADEQ and N. Levin, EPA re: Appendix 2.
.


[Federal Register Volume 87, Number 37 (Thursday, February 24, 2022)]
[Notices]
[Pages 10361-10362]
[FR Doc No: 2022-03861]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-SFUND-2015-0100; FRL-9341-01-OLEM]

Proposed Information Collection Request; Comment Request; Renewal
of Information Collection Request for the Continuous Release Reporting
Requirement Including Analysis for Use of Continuous Release Reporting
Forms, EPA ICR No. 1445.15, OMB Control Number 2050-0086

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR), ``Renewal of
Information Collection Request for the Continuous Release Reporting
Requirement Including Analysis for Use of Continuous Release Reporting
Forms'' (EPA ICR No. 1445.15, OMB Control No. 2050-0086) to the Office
of Management and Budget (OMB) for review and approval in accordance
with the Paperwork Reduction Act. Before doing so, EPA is soliciting
public comments on specific aspects of the proposed information
collection as described in Supplementary Information. This is a
proposed extension of the ICR, which is currently approved through
November 30, 2022. 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.

DATES: Comments must be submitted on or before April 25, 2022.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-
SFUND-2015-0100, to: (1) EPA online using www.regulations.gov (our
preferred method), by mail to: EPA Docket Center, Environmental
Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW,
Washington, DC 20460, and (2) OMB via email to
[email protected]. Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Wendy Hoffman, Office of Emergency
Management, Mail Code 5104A, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202)
564-8794; email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that EPA will be collecting are available in the public
docket for this ICR. The docket can be viewed online at http://www.regulations.gov. Out of an abundance of caution for members of the
public and our staff, the EPA Docket Center and Reading Room is closed
to the public, with limited exceptions, to reduce the risk of
transmitting COVID-19. Our Docket Center staff will continue to provide
remote customer service via email, phone, and webform. For further
information about the EPA's public docket, Docket Center services and
the current status, please visit us online at https://www.epa.gov/dockets. The telephone number for the Docket Center is<PHONE_NUMBER>.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) 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; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) 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. 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. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: Pursuant to section 3506(c)(2)(A) of the PRA, in the
first FR notice published on May 30, 2018, EPA solicited comments and
information pertaining to the Continuous Release Reporting Requirements
(CRRR) under Section 103(a) of CERCLA, as amended. CRRR requires the
person in charge of a vessel or facility immediately to notify the
National Response Center (NRC) of a hazardous substance release into
the environment if the amount of the release equals or exceeds the
substance's reportable quantity (RQ). The RQ of every hazardous
substance can be found in Table 302.4 of 40 CFR 302.4. If the source
and chemical composition of the continuous release do not change and
the level of the continuous release does not significantly increase, a
follow-up written report to the EPA Region one year after submission of
the initial written report is also required. The person in charge must
notify the NRC and EPA Region of a change in the source or composition
of the release, and under section 103(a) of CERCLA, a significant
increase must be reported immediately to the NRC. Finally, any change
in information submitted in support of a continuous release
notification must be reported to the EPA Region. Section 103(f)(2) of
CERCLA provides facilities relief from per-occurrence notification
release requirements if the subject release is continuous and stable in
quantity and rate.
    The Continuous Release Reporting Requirement allows the Federal
government to determine whether a Federal response action is required
to control or mitigate any potential adverse effects to public health,
welfare or the environment. The release information is also available
to EPA program offices and other Federal agencies that evaluate the
potential need for additional regulations, new permitting requirements
for specific substances or sources, or improved emergency response
planning. State and local government authorities and facilities subject
to the CRRR use release information for local emergency response
planning. The public, which has access to release information through
the Freedom of Information Act, may request release information on what
types of releases are occurring in different localities and what
actions, if any, are being taken to protect public health, welfare and
the environment. 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 burden estimates, numbers and types of respondents, wage rates
and unit and total costs for this ICR renewal will be revised and
updated, if needed, during the 60-day comment period while the ICR
Supporting Statement is undergoing review at OMB.
    Form Numbers: EPA Form 6100-10, Continuous Release Reporting Form.
    Respondents/affected entities: Entities potentially affected by
this action are not defined. The use and release of hazardous
substances are pervasive throughout industry. EPA expects many
different industrial categories to report hazardous substance releases
under the provisions of the CRRR. No one industry sector or group of
sectors is disproportionately affected by the information collection
burden.
    Respondent's obligation to respond: Mandatory if respondents want
reduced reporting for continuous releases. See the abstract for
details.
    Estimated number of respondents: 4,192.
    Frequency of response: On occasion.
    Total estimated burden: 334,472 hours (average per year). Burden is
defined at 5 CFR 1320.03(b).
    Total estimated cost: $19,797,899 (average per year), including
$243,200 annualized capital or operation & maintenance costs (average
per year).
    Changes in estimates: Any change in burden or cost resulting from
the 60-day OMB review period will be described and explained in this
section when the updated ICR Supporting Statement is completed.

Donna Salyer,
Director, Office of Emergency Management.
[FR Doc. 2022-03861 Filed 2-23-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 21 (Thursday, January 31, 2019)]
[Notices]
[Pages 842-843]
[FR Doc No: 2019-00475]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84965; File No. SR-BX-2018-066]

Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Equity 7,
Section 115

December 26, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 20, 2018, Nasdaq BX, Inc. (``BX'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I, II, and III, below,
which Items have been prepared by the Exchange. 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\ 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 Exchange's port fee schedule at
Equity 7, Section 115, as described further below.
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqbx.cchwallstreet.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 Exchange 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 these 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 aspects of such
statements.

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

1. Purpose
    The Exchange proposes to amend its fee schedule, at Equity 7,
Section 115, to clarify its existing practice for assessing port fees.
    Presently, the Exchange assigns ports to customers that request
them using the customers' Market Participant Identifiers or ``MPIDs.''
The Exchange assesses ports fees in two ways.
    First, for certain port types--i.e., Multicast TotalView-ITCH, TCP
ITCH data feed, DROP, and their corresponding disaster recovery ports--
the Exchange assigns a port only to the MPID of the customer that
requested it. Even if, as a practical matter, others also utilize the
port, the Exchange will only bill the MPID of the customer that
requested the port. The requesting customer may then, at its
discretion, subsequently bill any other users for their shared usage of
the port.
    Second, for other port types--i.e., OUCH, FIX Trading Ports (FIX
and FIX Lite), RASH, and their corresponding disaster recovery ports--
the Exchange assigns the port to the MPID of the customer that
requested it as well as to any other MPIDs that the requester had
specified. In these instances, the Exchange does not only bill the
port-requesting MPID. Instead, the Exchange assesses a separate monthly
fee to each of the MPIDs it assigned to the port.
    The existing port fee schedule, at Section 115, does not explain
these nuances of Exchange's port billing practices. Instead, Section
115 states simply, for all port types, that the Exchange will assess
fees of certain stated amounts on a per port, per month basis. Although
this existing language is accurate, the Exchange believes that it
should be more descriptive so as to avoid confusion as to the
circumstances in which a customer will incur port fees. The Exchange
now proposes to amend Section 115 to provide a more fulsome explanation
of its billing practices.
    To accomplish this, the Exchange proposes to reorganize its chart
of ports and associated fees in the second paragraph of Section 115.
Specifically, the Exchange proposes to split this chart into two parts.
    The first part of the proposed amended chart will comprise port
types for which the Exchange will charge a separate monthly fee to each
MPID that it has assigned to a port, i.e., OUCH, FIX Trading Port (FIX
and FIX Lite (FLITE), RASH, and disaster recovery ports for OUCH, FIX
Trading Port, and RASH. The first part of the chart will include the
following preface to explain the Exchange's pertinent billing practice:

For the port types listed immediately below, where a customer has
requested that the Exchange assign more than one MPID to a particular
port, then the Exchange will assess a separate monthly fee to each MPID
assigned to the port.

The Exchange also proposes to revise its description of the price
formula for each port type therein from ``$X/port/month'' to ``$X/each
MPID assigned to port/month.''
    The second part of the proposed amended chart will comprise port
types for which the Exchange will charge a monthly fee only to the MPID
that requested the port, i.e., Multicast TotalView-ITCH (software
based), TCP ITCH data feed, DROP, Trading Ports used in Test Mode, and
the disaster recover port for DROP.\3\ This part will include the
following preface describing the applicable billing practice:
---------------------------------------------------------------------------

    \3\ It also includes ports for which the exchange charges no
fee--Data Retransmission Ports and other disaster recover ports. The
Exchange proposes to add a parenthetical with the word ``Glimpse''
next to Data Retransmission Ports to clarify that that such Ports
include access to the ``Glimpse'' product, which allows a subscriber
to replay market data from the current trading day.
---------------------------------------------------------------------------

    For the port types listed immediately below, the Exchange will
assess the monthly fee to the single MPID that requested that
particular port. For the ports in this part, the Exchange will maintain
its existing price formula: ``$X/port/month.''
    The Exchange emphasizes that the foregoing proposal does not make
any change to the Exchange's existing port fees other than to clarify
its existing practices for assessing them.\4\
---------------------------------------------------------------------------

    \4\ The Exchange proposes to correct a typographical error in
the existing Rule text. Presently, the Rule contains the following
footnote: ``[dagger]Fees are assessed in full month increments under
this section, and thus are not prorated.'' However, the footnote is
not associated with anything in the main section of the Rule. This
is an unintended error. The Exchange proposes to correct this error
by placing the symbol ``[dagger]'' immediately after the heading of
Section 115.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\5\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act,\6\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using any facility, and is
not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange believes that the proposal is reasonable because it
clarifies the Exchange's port fee schedule, at Section 115. Although
existing Section 115 is an accurate description of the fees that the
Exchange

charges for ports, it does not describe the nuances of the Exchange's
existing practices for assessing port fees in different situations. The
proposal will convey these nuances in order to avoid potential
confusion among customers as to the circumstances in which they will
incur port fees. In particular, the proposal will amend Section 115 to
state that, for certain enumerated port types, the Exchange will assess
a monthly fee only on the MPID that requested the port, whereas in
other enumerated port types, the Exchange will assess a separate fee to
the requesting MPID as well as to each additional MPID that the
requester asked the Exchange to assign to the same port.
    The Exchange believes that this proposal is also equitable in that
a more fulsome description of the Exchange's port fee practices will
help to avoid any potential confusion as to when and under what
circumstances the Exchange will assess a monthly port fee to a
customer. The Exchange notes that the proposal merely codifies the
existing practices of the Exchange with respect to port fees and will
not involve any substantive changes to the fees that the Exchange's
customers are paying now.
    Finally, the Exchange believes that its proposal is not unfairly
discriminatory because, again, the proposal will merely make non-
substantive clarifications to Section 115 that will codify the
Exchange's existing practices for assessing port fees in different
situations. The proposal will not make any changes to the fees that
port users pay presently.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. Insofar as the proposal merely
codifies existing practice and makes no changes to the fees that the
Exchange charges presently, the Exchange does not expect that the
proposal will have any impact on competition whatsoever.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\7\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

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-BX-2018-066 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-BX-2018-066. 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 website (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 website 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 the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-BX-2018-066, and should be submitted on
or before February 21, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-00475 Filed 1-30-19; 8:45 am]
BILLING CODE P


[Federal Register Volume 78, Number 96 (Friday, May 17, 2013)]
[Notices]
[Pages 29141-29142]
[FR Doc No: 2013-11706]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0893]

Center for Devices and Radiological Health Appeals Processes;
Guidance for Industry and FDA Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Center for Devices and
Radiological Health (CDRH) Appeals Processes.'' This document describes
the processes available to outside stakeholders to request additional
review of decisions or actions by CDRH employees which include requests
for supervisory review of an action, petitions, and hearings. Of these,
the most commonly used process is the request for supervisory review (a
``10.75 appeal''). This document provides general information about
each process as well as guidance on how to submit related requests to
CDRH and FDA.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Center for Devices and Radiological Health Appeals
Processes''

to the Division of Small Manufacturers, International and Consumer
Assistance, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 4613, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or fax your request to 301-847-
8149. See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: David S. Buckles, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G470, Silver Spring, MD 20993-0002, 301-
796-5447.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance supersedes two previous guidance documents: ``Medical
Device Appeals and Complaints: Guidance for Dispute Resolution,'' dated
February 1998 and ``Resolving Scientific Disputes Concerning the
Regulation of Medical Devices, A Guide to Use of the Medical Devices
Dispute Resolution Panel; Final Guidance for Industry and FDA,'' dated
July 2001.
    In the Federal Register of December 28, 2011 (76 FR 81511), FDA
announced the availability of the draft of this guidance. Interested
persons were invited to comment by April 26, 2012. In July 2012,
section 517A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360g-1) was added by section 603 of the FDA Safety and
Innovation Act (FDASIA) (Pub. L. 112-114). FDA considered the public
comments received and revised the guidance, as appropriate, and in
accordance with the new requirements established by section 603 of
FDASIA.
    Section 517A includes new requirements pertaining to the process
and timelines for appeals, made under 21 CFR 10.75 (10.75 appeal) of
``significant decisions'' regarding 510(k) premarket notifications,
applications for premarket approval (PMAs), and applications for
investigational device exemptions (IDEs). In this guidance document,
the term ``significant decision'' refers to significant decisions
pertaining to these submissions.
    Elsewhere in this issue of the Federal Register, FDA is announcing
the Agency's proposed interpretation of this provision (for example,
what constitutes a ``significant decision'') in a draft guidance
document entitled ``Center for Devices and Radiological Health Appeals
Processes: Questions and Answers About 517A.''

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on CDRH's Appeals Processes. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statute and
regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
using the Internet. A search capability for all CDRH guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov.

To receive ``Center for Devices and Radiological Health Appeals
Processes'' you may either send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document or send a fax request to
301-847-8149 to receive a hard copy. Please use the document number
1742 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in the guidance document ``Center for
Devices and Radiological Health Appeals Processes'' are approved under
OMB control number 0910-0738. The guidance also refers to currently
approved information collections found in FDA regulations. The
collections of information in 21 CFR 10.30, 21 CFR 10.33, and 21 CFR
10.35 are approved under OMB control number 0910-0183; the collections
of information in 21 CFR part 12 are approved under OMB control number
0910-0184; and the collections of information under 21 CFR part 900 are
approved under OMB control number 0910-0309.

V. Comments

    Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: May 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11706 Filed 5-16-13; 8:45 am]
BILLING CODE 4160-01-P