Agricultural Marketing Service
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Food and Drug Administration
National Institutes of Health
U.S. Customs and Border Protection
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Agricultural Marketing Service, USDA.
Final rule.
This final rule informs the public that the U.S. Department of Agriculture's (USDA) Agricultural Marketing Service (AMS) is amending its regulations to update a number of outdated administrative and organizational references, clarify agency action as it relates to the withdrawal or denial of service, update the official shields and grademarks associated with the grading service, and make reference to the use of instrument grading equipment as a means of determining official grades on beef and lamb carcasses.
This final rule is effective September 16, 2019.
Dana K. Stahl, Chief, Grading Services Branch, QAD, Livestock and Poultry Program, AMS, USDA; 1400 Independence Avenue SW; Room 3932-S, Stop 0258, Washington, DC 20250-0258; (202) 690-3169; or email to
This rulemaking does not meet the definition of a significant regulatory action contained in section 3(f) of Executive Order 12866 and is not subject to review by the Office of Management and Budget (OMB). Additionally, because this rule does not meet the definition of a significant regulatory action it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled 'Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).
Pursuant to the requirements set forth in the Regulatory Flexibility Act (RFA) [5 U.S.C. 601
Currently, approximately 235 applicants subscribe to AMS's voluntary, user fee services. The U.S. Small Business Administration's Table of Small Business Size Standards matched to the North American Industry Classification System (NAICS) Codes identifies small business size by average annual receipts or by the average number of employees at a firm. This information can be found at 13 CFR parts 121.104, 121.106, and 121.201.
AMS requires that all applicants for service provide information about their company for the purpose of processing bills. Information collected from an applicant includes company name, address, billing address, and similar information. AMS does not collect information about the size of the business. However, based on working knowledge of these operations, AMS estimates that roughly 72 percent of current applicants may be classified as small entities. It is not anticipated that this action will impose additional costs to applicants, regardless of size. Current applicants will not be required to provide any additional information to receive service. The effects of this final rule are not expected to be disproportionately greater or lesser for small applicants than for large applicants.
AMS is committed to complying with the E-Government Act of 2002 [44 U.S.C. 101] to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to government information and services, and for other purposes. Accordingly, AMS developed options for companies requesting service to do so electronically.
The USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule.
Pursuant to the Congressional Review Act [5 U.S.C. 801
This action has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this regulation will not have substantial and direct effects on Tribal governments and will not have significant Tribal implications.
This final rule has been reviewed under Executive Order (E.O.) 12988, Civil Justice Reform. This final rule is not intended to have retroactive effect. The E.O. prohibits states or political subdivisions of a state to impose any requirement that is in addition to, or inconsistent with, any requirement of the E.O. There are no civil justice implications associated with this final rule.
In accordance with the Paperwork Reduction Act of 1995 [44 U.S.C. Chapter 35], this final rule will not change the information collection and recordkeeping requirements previously approved and would not impose additional reporting or recordkeeping burden on users of these voluntary services.
The information collection and recordkeeping requirements of this part have been approved by OMB under 44 U.S.C. Chapter 35 and have been assigned OMB Control Number 0581-0128.
In September 2014, three separate OMB collections—OMB 0581-0127, OMB 0581-0124, and OMB 0581-0128—were merged, such that the current OMB 0581-0128 pertains to Regulations for Voluntary Grading, Certification, and Standards and includes 7 CFR parts 54, 56, 62, and 70.
The Agricultural Marketing Act of 1946 (7 U.S.C. 1621
In 2012, an organizational merger within AMS combined the Livestock and Seed Program and Poultry Programs into the Livestock, Poultry, and Seed (LPS) Program. Subsequently, the LPS Program created the Quality Assessment Division (QAD) to oversee services carried out by the Audit Services Branch, Grading Services Branch, Standardization Branch, and the Business Operations Branch. The Grading Services Branch administers grading and certification services that were performed by the former Meat Grading and Certification Branch of the former Livestock and Seed Program and the former Grading Branch of Poultry Programs. In 2018, another organizational change caused the LPS Program to be renamed the Livestock and Poultry Program.
Meat grading and certification activities are carried out under 7 CFR 54, while poultry and shell egg grading and certification activities are carried out under 7 CFR 70 and 7 CFR 56, respectively.
Through this rulemaking, AMS will update a number of administrative and organizational references to reflect the current terminology and structure of AMS. These amendments include amending § 54.1 to change the LPS Program to the Livestock and Poultry Program. Certain terms and definitions will be added to, updated in, or deleted from § 54.1 to reflect the current organizational structure within the Agency. The term and definition for
Since this regulation has not received significant revisions for some time, AMS is revising it to make it consistent with The Plain Writing Act of 2010 [Pub. L. 111-274]. To accomplish this, AMS is focusing on appropriate pronoun use, omitting unnecessary words, and writing short sentences.
To reflect organizational changes and for consistency with other changes to this regulation, AMS will amend § 54.4
AMS will also amend § 54.5
AMS will amend § 54.6
AMS will remove the reference to the Medium grade for lamb, yearling lamb, mutton, and pork carcasses in § 54.11(a)(1)(vii). The official standards for grades of lamb and mutton carcasses were amended in October 1940 (Amendment No. 1 to S.R.A. 123) to change the grade designations Medium and Common to Commercial and Utility, respectively. In April 1968, the official standards for pork carcasses were revised and the former Medium and Cull grades were combined and renamed U.S. Utility. Removing the reference to Medium in § 54.11(a)(1)(vii) aligns the regulatory language with the language contained within the official standards.
AMS will create a stair-stepped approach regarding denial or withdrawal of Grading Services Branch services. As written, § 54.11 requires AMS to go before an administrative law judge to hear a case for an applicant accused of misconduct before any action can be taken; the process and actions currently identified in this part limit AMS's ability to effectively manage its services, including denying, withdrawing, or suspending services in a timely manner when warranted for reasons of misconduct. Therefore, AMS is clarifying that it shall rely first on the Supplemental Rules of Practice in 7 CFR 50 and then, if necessary, use the Rules of Practice Governing Formal Adjudicatory Proceedings Instituted by the Secretary Under Various Statues set forth in 7 CFR 1.130 through 1.151 when denying, withdrawing, or suspending services to applicants. An applicant will still have an opportunity for a hearing before an administrative law judge before any permanent action occurs.
The regulations outlined in this part are intended to describe to the public how AMS provides grading and
In 2001, vision-based instrument technology was approved for use in the official determination of the size of the ribeye area. In 2007, it was approved for yield grade determination, and in 2009, it was approved for marbling assessment. Although this technology has been used as an aid in the application of official USDA beef grades since 2001, the current regulations make no mention of it. AMS considers the use of instrument technology to be an important option for determining degrees of marbling in meat carcasses and yield and, therefore, is adding a reference to it in § 54.15.
AMS will appropriately identify and reference figures within § 54.17. Currently, multiple figures in that section contain the same label, Figure 1, which makes it difficult to accurately reference any one particular figure. AMS will remove the Carcass Data Service orange ear tag from § 54.17, because the Agency no longer prints or maintains them and instead allows cattle enrolled in the Carcass Data Service to be identified through other approved methods. AMS will appropriately identify and reference in § 54.17 the USDA Further Processing Certification Program shield used to identify product produced under the USDA Further Processing Certification Program. Additionally, AMS will amend language within this section to accurately identify the USDA Hold tag that is now used in place of the USDA Product Control tag. The tag is now red in color as opposed to orange.
Within § 54.19, AMS will remove the heading APPEAL SERVICE, rename § 54.19 as
AMS will rename § 54.20
Together, amendments to §§ 54.5
AMS will remove and reserve § 54.30
Lastly, AMS will replace the title and language of § 54.31
A proposed rule to amend the Regulations Governing Meats, Prepared Meats, and Meat Products (Grading, Certification, and Standards) was published in the
Three consumer commenters supported all the amendments as beneficial for consumers and producers of meat products, while two consumer commenters were supportive of the amendments with the exception of 54.13(d), which requires that applicants for grading service make products, records, and equipment accessible so that graders may perform their duties effectively. This includes offering product for grading or certification that is, at a minimum, 90 percent acceptable. The two commenters suggested that this number should be increased to 100 percent. In response, AMS will maintain the requirement as written in the proposed rule, as 90 percent reflects a practical and achievable goal that effectively limits ineligible product from being offered for grading and certification.
The 3 industry commenters and 1 company commenter generally supported the changes in the proposed rule, with a few exceptions.
One commenter pointed out that the definition in § 54.1 for “Institutional Meat Purchase Specifications” should be amended to include quotation marks to designate “IMPS” as an acronym and the definition of “meat by-products” should be consistent with that used by the Food Safety and Inspection Service. In response to these suggestions, the Agency is revising the proposed language for the definitions of “Institutional Meat Purchase Specifications” and “meat by-products.”
One commenter suggested that AMS provide background on the change to the reimbursement requirements in § 54.6 from 1 year to 2 years, stating that AMS did not provide justification or an impact analysis for this change. AMS proposed this change, requiring that the applicant be responsible for the cost of relocating a grader should it cancel its commitment service and then reinstate it within 2 years, in light of the significant expense and disruption to the Agency of relocating a grader multiple times within a short period of time, based on previous experience. Expanding this requirement to a 2-year timeframe will help AMS continue to provide consistent service and a stable work environment for AMS employees. Therefore, AMS will maintain the requirement as amended in the proposed rule.
Regarding § 54.11, one commenter recommended revising language in the preamble of the final rule to show the distinct order of AMS procedures when denying, withdrawing, or suspending service that “reflects agency practice and does not represent a tangible change.” AMS agrees and has added clarifying language to the preamble.
One commenter suggested a revision in 54.13(a) that would replace the word “any” with “covered” or a similar phrase to clarify the regulatory intent when talking about marks of grade or compliance. AMS has determined not to make this change. By referencing “any
One industry commenter supported the reference to instrument grading in section in § 54.15 and urged USDA to ensure consistency of instrument grading calibration.
One industry commenter supported the proposed changes to the marketing grade terms (
Several comments were received regarding the proposed changes to § 54.5 and § 54.20 with respect to grading of imported carcasses. One commenter asked for clarification on whether, as a result of the proposed changes, the eligibility of imported product would change significantly. The answer is no. The regulations and AMS procedures allow the Agency to grant exemptions to grade imported product in carcass form, enabling AMS to use all parts of the official standards to determine the appropriate grade. AMS is clarifying that exemptions have always been required for the official grading of imported carcasses since § 54.5 requires that carcasses come from animals slaughtered in establishments that are federally inspected or operated under state meat inspection. In the final rule, this requirement is maintained under § 54.5 and language is added to clarify that the grading of imported carcasses is allowed only under an exemption approved by the Director.
Two commenters supported the general guidance in § 54.20 allowing additional flexibility under exemptions granted by the Agency. One commenter opposed the proposed amendment to § 54.5 that service “may be furnished” instead of “will be furnished” for imported meat, suggesting instead that the phrase be changed to “shall be provided.” Another commenter recommended a change to the proposed language in § 54.20 authorizing the Director to issue exemptions, requesting that “shall issue” be added. After consideration, AMS will proceed with language of the proposed rule in § 54.5 and § 54.20 with minor changes. The Agency believes that maintaining flexibility in the process by which the Director may approve or deny exemptions is necessary to enhance commerce while ensuring decisions are for good cause and based upon the supporting documentation provided by the applicant. Changing the word “will” to “may” supports the Agency's due diligence to ensure minimal impact upon the industry should an exemption be granted and to deny requests if determined otherwise.
One commenter supported the language in § 54.20 that provides an exemption allowing for the grading of meat in other-than-carcass form “if the class, grade, and other quality attributes may be determined under the applicable standards.” This commenter suggested that as long as an establishment can demonstrate that products presented for grading are of the proper class and maturity, and the grade can be determined based on the quality attributes of the meat, there is no need to limit grading services to whole carcasses. The commenter referenced an exemption that AMS granted in 2017 for the grading of ribs and loins imported from Mexico. The commenter also asked AMS to clarify, in the final rule or in guidance, what criteria must be satisfied to demonstrate an animal's class when meat is presented for grading in other-than-carcass form.
In response, AMS maintains that the official standards are written in terms of carcasses and sides, and thus the grading of product in less-than-carcass form is generally contrary to the standards. AMS maintains the flexibility to grant exemptions for product presented in other-than-carcass form, but these exemptions are typically for religious reasons where a whole carcass has been presented for grading as quarters instead of sides. In contrast, AMS maintains that subprimal parts, such as ribs and loins, present insufficient criteria by which a grader may make an adequate class or quality determination. Therefore, AMS will maintain the proposed language in § 54.20 with one clarifying change: references to “meat from imported animals” and “imported meat” are changed to “imported carcasses” for clarity and accuracy.
Coinciding with the publication of this final rule, AMS will be amending its procedures (QAD Procedure 504 Import Grading) accordingly.
One industry commenter opposed any reciprocity of official standards and services of USDA beef grades outside the U.S. and also opposed other countries utilizing USDA's system and associated terms. While AMS considers this comment to be outside the scope of this rulemaking, we recognize the industry's concerns.
Food grades and standards, Food labeling, Meat and meat products, Poultry and poultry products.
For the reasons set forth in the preamble, AMS amends 7 CFR part 54 as follows:
7 U.S.C. 1621-1627.
The revisions and additions read as follows:
(a) Grading Service consists of the determination, certification, and identification of the class, grade, or other quality attributes of products under applicable official standards.
(b) Certification Service consists of the determination, certification, and identification of products to an approved specification. Determination of product compliance with specifications for ingredient content or method of preparation may be based upon information received from the inspection system having jurisdiction over the products involved.
(c) Carcass Data Service consists of the evaluation of carcass characteristics of animals identified with an approved ear tag to applicable official standards or specifications, and the recording and transmitting of the associated data to the applicant or a party designated by the applicant.
Service under these regulations may be made available to products shipped or received in interstate commerce. It also may be made available to the products not shipped or received if the Director or Chief determines that the furnishing of service for such products will facilitate the marketing, distribution, processing, or utilization of agricultural products through commercial channels. Service will be furnished for products only if they were derived from animals slaughtered in federally inspected establishments or establishments operated under state meat inspection in a state other than one designated in 9 CFR 331.2. Service may be furnished for imported carcasses only if an exemption to do so is granted by the Director as described in § 54.20.
(a)
(1) Name and address of the establishment at which service is desired;
(2) Name and mailing address of the applicant;
(3) Financial interest of the applicant in the products, except where application is made by a representative of a Government agency in the representative's official capacity;
(4) Signature of the applicant (or the signature and title of the applicant's representative);
(5) Indication of the legal status of the applicant as an individual, partnership, corporation, or other form of legal entity; and
(6) The legal designation of the applicant's business as a small or large business, as defined by the U.S. Small Business Administration's North American Industry Classification System (NAICS) Codes.
(b)
(c)
(2)
(3) If an applicant who terminates commitment grading service requests service again within a 2-year period from the date of the initial termination, the applicant will be responsible for all relocation costs associated with the grader assigned to fulfill the new service agreement. If more than one applicant is involved, expenses will be prorated according to each applicant's committed portion of the official grader's services.
Service shall be furnished to applicants in the order in which requests are received. Preference will be given, when necessary, to requests made by any government agency or any regular user of the service, and to requests for appeal service under § 54.19.
A request for service is considered made when received by the designated office as identified on the Application for Service form. Records showing the date and time of the request shall be made and maintained in the designated office.
An application or a request for service may be withdrawn by the applicant at any time before the application is approved or prior to performance of service. In accordance with §§ 54.27 and 54.28, any expenses already incurred by AMS in connection with the review of an application or fulfilling a request for service are the responsibility of the applicant.
Proof that any person making an application or a request for service on behalf of any other person has the authority to do so may be required at the discretion of the Director or Chief.
(a) * * *
(1)
(i) Has willfully made any misrepresentation or has committed any other fraudulent or deceptive practice in connection with any application or request for service;
(ii) Has given or attempted to give, as a loan or for any other purpose, any money, favor, or other thing of value, to any employee of the Department authorized to perform any function;
(iii) Has interfered with or obstructed, or attempted to interfere with or to obstruct, any employee of the Department in the performance of his or her duties under the regulations by intimidation, threats, assaults, abuse, or any other improper means;
(vii) Has applied the designation “US” or “USDA” and “Prime,” “Choice,” “Select,” “Good,” “Standard,” “Commercial,” “Utility,” “Cutter,” “Canner,” “Cull,” “No. 1,” “No. 2,” “No. 3,” “No. 4,” “Yield Grade 1,” “Yield Grade 2,” “Yield Grade 3,” “Yield Grade 4,” “Yield Grade 5,” and “USDA Accepted as Specified,” by stamp or text enclosed within a shield, or brand directly on any carcass, wholesale cut, or retail cut of any carcass, or has applied the aforementioned designations including “USDA Certified,” and “USDA Further Processing Certification Program” on the marketing material associated with any such product as part of a grade designation or product specification;
(x) Has in any manner not specified in this paragraph violated subsection 203(h) of the Act:
(
(
(B) In case the service is or would be performed with respect to any product with which any corporation, partnership, or other person within paragraph (a)(1)(x)(A)(1) of this section has a contract or other financial interest.
(2)
(a) The applicant shall make products easily accessible for examination, with appropriate and adequate illuminating facilities, in order to disclose their class, grade, other quality characteristics, and compliance with official standards or other contractual requirements for which service is being provided. Supervisors of grading and other employees of the Department responsible for maintaining uniformity and accuracy of service shall have access to all parts of establishments covered by approved applications for service under the regulations, for the purpose of examining all products in the establishments that have been or are to be graded or examined for compliance with specifications or which bear any marks of grade or compliance.
(b) Grading service will be furnished only for meat that an official grader determines is chilled so that grade factors are developed to the extent that
(c) Applicants are responsible for providing a work environment where official graders are not subjected to physical and/or verbal abuse, or other elements that could have a negative effect on providing an unbiased, third-party evaluation. Applicants shall designate primary company representatives to discuss grade placements and certification determinations with official graders.
(d) Applicants will make products and related records (approved labeling, technical proposals, quality plans, specifications, end product data schedules, grade volume information, etc.) easily accessible and provide assistance and any equipment necessary to accomplish the requested services. Equipment may include storage lockers/cabinets, branding ink, certified scales, food blenders, processors, grinders, sampling containers, sanitation equipment, thermometers, adequate lighting, weight tags, display monitors, video equipment for monitoring live animal schedules, etc. When offering product for grading or certification, applicants must ensure a minimum of 90 percent acceptable product.
(e) Applicants will provide a metal cabinet(s) or locker(s) for the secure storage of official meat grading equipment and identification devices for each official meat grader assigned to their establishment. Such cabinet(s) or locker(s) must be capable of being locked with a Government-owned lock and be located in an easily accessible and secure location within the applicant's establishment.
(a) Applicants may use USDA-approved technologies to augment the official USDA grading process for approved species presented for official grading. This voluntary program may be utilized by a plant at its discretion but must comply with QAD procedures to be recognized and relied upon by the official grader in conducting official duties.
(b) Applicants have the option to augment quality and yield grading services through the use of vision-based instrument technology. Instrument grading may be used as an option for determining degrees of marbling and yield factors for meat carcasses. AMS approves the grading instrument itself and its use within individual applicant facilities. Applicants may contact grading supervision to initiate the process for in-plant approval. The process for instrument grading approval at an applicant's facility is dictated through internal procedures. Final determination of quality and yield grades is made by the official grader.
All products examined for class and grade under the official standards, or the immediate containers and the shipping containers, shall be stamped, branded, or otherwise marked with an appropriate official identification. Except as otherwise directed by the Director, such markings will not be required when an applicant desires only an official memorandum. The marking of products, or their containers, as required by this section shall be done by official graders or under their immediate supervision.
(a) A shield enclosing the letters “USDA” and identification letters assigned to the grader performing the service, as shown in Figure 1 to paragraph (a) of this section, constitutes a form of official identification under the regulations for preliminary grade of carcasses. This form of official identification may also be used to determine the final quality grade of carcasses; one stamp equates to “USDA Select” or “USDA Good”; two stamps placed together vertically equates to “USDA Choice”; and three stamps placed together vertically equates to “USDA Prime.”
(b) A shield enclosing the letters “USDA,” as shown in Figure 2 to paragraph (b) of this section, with the appropriate quality grade designation “Prime,” “Choice,” “Select,” “Good,” “Standard,” “Commercial,” “Utility,” “Cutter,” “Canner,” or “Cull,” as provided in the United States Standards for Grades of Carcass Beef, the United States Standards for Grades of Veal and Calf Carcasses, and the United States Standards for Grades of Lamb, Yearling Mutton, and Mutton Carcasses; and accompanied by the class designation “Bullock,” “Veal,” “Calf,” “Lamb,” “Yearling Mutton,” or “Mutton,” constitutes a form of official identification under the regulations to show the quality grade, and where necessary, the class, under said standards, of steer, heifer, and cow beef, veal, calf, lamb, yearling mutton, and mutton. The identification letters assigned to the grader performing the service will appear underneath and outside of the shield.
(c) A shield enclosing the letters “USDA” and the words “Yield Grade,” as in Figure 3 to paragraph (c) of this section, with the appropriate yield grade designation “1,” “2,” “3,” “4,” or “5” as provided in the United States Standards for Grades of Carcass Beef and the United States Standards for Grades of Lamb, Yearling Mutton, and Mutton Carcasses, constitutes a form of official identification under the regulations to show the yield grade under said standards. When yield graded, bull and bullock carcasses will be identified with the class designation “Bull” and “Bullock,” respectively. The identification letters assigned to the grader performing the service will appear underneath and outside of the shield.
(d) For combined quality and yield grade identification purposes only, a shield enclosing the letters “US” on one side and “DA” on the other, with the appropriate yield grade designation number “1,” “2,” “3,” “4,” or “5,” and with the appropriate quality grade designation of “Prime,” “Choice,” “Select,” “Good,” “Standard,” “Commercial,” “Utility,” “Cutter,” “Canner,” or “Cull,” as shown in Figure 4 to paragraph (d) of this section, constitutes a form of official identification under the regulations to show the quality and yield grade under said standards. The identification letters assigned to the grader performing the service will appear underneath and outside of the shield.
(e) Under the regulations, for yield grade identification purposes only, a shield enclosing the letters “US” on one side and “DA” on the other, and with the appropriate yield grade designation number “1,” “2,” “3,” “4,” or “5,” as shown in Figure 5 to paragraph (e) of this section, constitutes a form of official identification under the regulations to show the yield grade under said standards. The identification letters assigned to the grader performing the service will appear underneath and outside of the shield.
(f) For quality grade identification only, a shield enclosing the letters “US” on one side and “DA” on the other with the appropriate quality grade designation of “Prime,” “Choice,” “Select,” “Good,” “Standard,” “Commercial,” “Utility,” “Cutter,” “Canner,” or “Cull,” as shown in Figure 6 to paragraph (f) of this section, constitutes a form of official identification under the regulations to show the yield grade under said standards. The identification letters assigned to the grader performing the service will appear underneath and outside of the shield.
(g) As shown in Figure 7 to paragraph (g) of this section, a shield enclosing the letters “USDA” with the appropriate grade designation “1,” “2,” “3,” “4,” or “Utility,” as provided in the Official United States Standards for Grades of Pork Carcasses, constitutes a form of official identification under the regulations to show the grade under said standards of barrow, gilt, and sow pork carcasses.
(h) The following constitute forms of official identification under the regulations to show compliance of products:
(i) Figure 10 to paragraph (i) of this section, constitutes official identification to show quality system certification.
(j) Figure 11 to paragraph (j) of this section, constitutes official identification to show that products produced under USDA AMS supervision that meet specified requirements may carry the “USDA Certified” statement and/or “USDA Certified” shield, so long as each is used in direct association with a clear description of the standard or other requirement(s) to which the product claims to be certified.
(1) The “USDA Certified” shield must replicate the form and design of the example in Figure 11 and must be printed legibly and conspicuously:
(i) On a white background, with the term “USDA” in white overlaying a blue upper third of the shield and the term “Certified” in black overlaying a white middle third of the shield, with no terms in the red lower third of the shield; or
(ii) On a white or transparent background with a black trimmed shield, with the term “USDA” in white overlaying a black upper third of the shield and the term “Certified” in black overlaying the white or transparent remaining two-thirds of the shield.
(2) Use of the “USDA Certified” statement and the “USDA Certified” shield shall be approved in writing by the Director prior to use by an applicant.
(k) Figure 12 to paragraph (k) of this section, constitutes official identification to show product or services produced under an approved USDA Further Processing Certification Program (FPCP):
(1) Products produced under an approved USDA FPCP may use the “USDA Further Processing Certification Program” statement and the “USDA Further Processing Certification Program” shield; and
(2) The USDA Further Processing Certification Program shield must replicate the form and design of the example in Figure 12 to paragraph (k) of this section and must be printed legibly and conspicuously:
(i) On a white background, with the term “USDA” in white overlaying a blue upper third of the shield and the terms “USDA Further Processing Certification Program” in black overlaying a white middle third of the shield, with no terms in the red lower third of the shield; or
(ii) On a white or transparent background with a black trimmed shield, with the term “USDA” in white overlaying a black upper third of the shield and the terms “USDA Further Processing Certification Program” in black overlaying the white or transparent remaining two-thirds of the shield.
(3) Use of the “USDA Further Processing Certification Program” statement and the “USDA Further Processing Certification Program” shield shall be approved in writing by the Director prior to use by an applicant.
(l)(1) One device used by official graders is the LP-36 Form, a rectangular, serially numbered, red tag on which a shield encloses the words “USDA Hold.” This device constitutes a form of official identification under the regulations for meat and meat products.
(2) Official graders and supervisors of grading may use “USDA Hold” tags or other methods and devices as approved by the Administrator for the identification and control of meat and meat products that are not in compliance with the regulations or are held pending the results of an examination. Any such meat or meat product identified shall not be used, moved, or altered in any manner; nor shall official control identification be removed, without the expressed permission of an authorized representative of the USDA.
(a) All identification devices used in marking products or their containers, including those indicating compliance with approved specifications, shall be kept in the custody of the Branch, and accurate records shall be kept by the Branch of all such devices. Such devices shall be distributed only to persons authorized by the Department, who will keep the devices in their possession or control at all times.
Appeal service is a redetermination of the class, grade, other quality, or compliance of product when the applicant for the appeal service formally challenges the correctness of the original determination.
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
Any exemption to the regulations must be approved by the Director. Exemptions may include but are not limited to:
(a) Grading the meat of animals in other than carcass form if the class, grade, and other quality attributes may be determined under the applicable official standards.
(b) Grading in an establishment other than where the animal was slaughtered or initially chilled if the class, grade, and other quality attributes can be determined under the applicable official standards, and if the identity of the carcasses can be maintained.
(c) If the Branch is unable to provide grading service in a timely manner and the meat can be identified in conformance with the official standards.
(d) Grading in the establishment other than where the hide is removed, provided the meat can be identified in conformance with the official standards.
(e) Grading imported carcasses, provided:
(1) The imported carcass is marked so that the name of the country of origin is conspicuous to the USDA grader. The mark of foreign origin shall be imprinted by roller brand, handstamp, tag, or other approved method.
(2) The imprints of the mark of foreign origin have been submitted to the Chief for the determination of compliance with these regulations prior to use on meats offered for Federal grading.
(3) The applicant notifies the official grader performing the service whenever imported carcasses are offered for grading.
(f) For good cause and provided that the meat can be identified in conformance with the official standards and procedures.
The information collection and recordkeeping requirements of this part have been approved by OMB under 44 U.S.C. Chapter 35 and have been assigned OMB Control Number 0581-0128.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
The FAA is adopting a new airworthiness directive (AD) for all Fokker Services B.V. Model F28 Mark 0070 and 0100 airplanes. This AD was prompted by reports of cracks on certain nose landing gear (NLG) turning tubes resulting from incorrectly applied repairs. This AD requires removing the affected parts and replacing them with serviceable parts. The FAA is issuing this AD to address the unsafe condition on these products.
This AD is effective October 21, 2019.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of October 21, 2019.
For Fokker service information identified in this final rule, contact Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350; fax +31 (0)88-6280-111; email
You may examine the AD docket on the internet at
Tom Rodriguez, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3226.
The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Fokker Services B.V. Model F28 Mark 0070 and 0100 airplanes. The NPRM published in the
The FAA is issuing this AD to address cracking of NLG turning tubes, which could lead to NLG turning tube failure, possibly resulting in damage to the airplane and injury to occupants.
The European Union Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2019-0037, dated February 19, 2019 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Fokker Services B.V. Model F28 Mark 0070 and 0100 airplanes. The MCAI states:
Occurrences have been reported of finding cracks on certain NLG turning tubes. The subsequent investigation results revealed that the cracks initiated from an area that is sensitive to fatigue cracking, which had been subject to incorrectly applied repairs.
This condition, if not detected and corrected, could lead to NLG turning tube
To address this potential unsafe condition, Fokker Services published the SB [service bulletin] to provide replacement instructions, referring to SLS [Safran Landing Systems] SB F100-32-117 for in-shop inspection.
For the reasons described above, this [EASA] AD requires removal from service of the affected part and replacement with a serviceable part.
You may examine the MCAI in the AD docket on the internet at
The FAA gave the public the opportunity to participate in developing this final rule. The FAA received no comments on the NPRM or on the determination of the cost to the public.
The FAA reviewed the relevant data and determined that air safety and the public interest require adopting this final rule as proposed, except for minor editorial changes. The FAA has determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for addressing the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
Fokker Services B.V. has issued Fokker Service Bulletin SBF100-32-171, dated November 27, 2018. This service information describes procedures for removing and replacing affected NLG turning tubes.
Safran Landing Systems has issued Safran Service Bulletin F100-32-117, dated July 30, 2018. This service information describes procedures for a magnetic particle or eddy current inspection of NLG turning tubes.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
Costs of Compliance
The FAA estimates that this AD affects 4 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Will not affect intrastate aviation in Alaska, and
(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective October 21, 2019.
None.
This AD applies to Fokker Services B.V. Model F28 Mark 0070 and 0100 airplanes, certificated in any category, all manufacturer serial numbers.
Air Transport Association (ATA) of America Code 32, Landing gear.
This AD was prompted by reports of cracks on certain nose landing gear (NLG) turning tubes resulting from incorrectly applied repairs. The FAA is issuing this AD to address cracking of NLG turning tubes, which could lead to NLG turning tube failure, possibly resulting in damage to the airplane and injury to occupants.
Comply with this AD within the compliance times specified, unless already done.
(1) An affected part is an NLG turning tube assembly having part number (P/N) 201456200, 201071202, 201071240, or
(2) A serviceable part is an affected part that is new or that, before installation, has passed an inspection (no cracks found, having the correct radius), in accordance with the Accomplishment Instructions of Safran Service Bulletin F100-32-117, dated July 30, 2018.
Within 22,000 flight cycles after the effective date of this AD: Replace the affected parts, with serviceable parts, in accordance with the Accomplishment Instructions of Fokker Service Bulletin SBF100-32-171, dated November 27, 2018.
As of the effective date of this AD, no person may install, on any airplane, an affected part, unless it is a serviceable part.
Although Safran Service Bulletin F100-32-117, dated July 30, 2018, specifies to submit certain information to the manufacturer, this AD does not include that requirement.
The following provisions also apply to this AD:
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2019-0037, dated February 19, 2019, for related information. This MCAI may be found in the AD docket on the internet at
(2) For more information about this AD, contact Tom Rodriguez, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3226.
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) Fokker Service Bulletin SBF100-32-171, dated November 27, 2018.
(ii) Safran Service Bulletin F100-32-117, dated July 30, 2018.
(3) For Fokker service information identified in this final rule, contact Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350; fax +31 (0)88-6280-111; email
(4) You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) Region 9 announces the deletion of the MGM Brakes Superfund Site (Site) located in Cloverdale, Sonoma County, California, from the National Priorities List (NPL). The NPL, promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). The EPA and the State of California, through the Department of Toxic Substances Control, have determined that all appropriate response actions under CERCLA have been completed. However, this deletion does not preclude future actions under Superfund.
This action is effective September 16, 2019.
Olivia Trombadore, Remedial Project Manager, U.S. Environmental Protection Agency, Region 9, SFD-9-2, 75 Hawthorne St., San Francisco, CA 94105, (415) 972-3973,
The site to be deleted from the NPL is: MGM Brakes Superfund Site, Cloverdale, Sonoma County, California. A Notice of Intent to Delete for this Site was published in the
The closing date for comments on the Notice of Intent to Delete was July 18, 2019. No public comments were received, and EPA still believes that this deletion action is appropriate.
EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare, or the environment. Deletion from the NPL does not preclude further remedial action. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system. Deletion of a site from the NPL does not affect responsible party liability in the unlikely event that future conditions warrant further actions.
Environmental protection, Air pollution control, Chemicals, Hazardous waste, Hazardous substances, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Superfund, Water pollution control, Water supply.
For reasons set out in the preamble, 40 CFR part 300 is amended as follows:
33 U.S.C. 1321(d); 42 U.S.C. 9601-9657; E.O. 13626, 77 FR 56749, 3 CFR, 2013 Comp., p. 306; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR, 1987 Comp., p. 193.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; quota transfer and closure.
NMFS transfers 60 metric tons (mt) of Atlantic bluefin tuna (BFT) quota from the Reserve category to the September 2019 General category subquota period and closes the General category fishery until the General category reopens on October 1, 2019. The quota transfer is intended to provide additional fishing opportunities based on consideration of the regulatory determination criteria regarding inseason adjustments and applies to Atlantic tunas General category (commercial) permitted vessels and Highly Migratory Species (HMS) Charter/Headboat category permitted vessels with a commercial sale endorsement when fishing commercially for BFT. Given that the adjusted quota is projected to be caught quickly, the closure is being filed simultaneously to prevent overharvest of the adjusted General category September 2019 BFT subquota.
The quota transfer is effective September 11, 2019, through September 30, 2019. The closure is effective 11:30 p.m., local time, September 13, 2019, through September 30, 2019.
Sarah McLaughlin, 978-281-9260, or Larry Redd, 301-420-8503.
Regulations implemented under the authority of the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971
NMFS is required, under regulations at § 635.28(a)(1), to file a closure notice for publication with the Office of the Federal Register when a BFT quota is reached or is projected to be reached. On and after the effective date and time of such notification, for the remainder of the fishing year or for a specified period as indicated in the notification, retaining, possessing, or landing BFT under that quota category is prohibited until the opening of the subsequent quota period or until such date as specified in the notice.
The current baseline General and Reserve category quotas are 555.7 mt and 29.5 mt, respectively. See § 635.27(a). Each of the General category time periods (January, June through August, September, October through November, and December) is allocated a “subquota” or portion of the annual General category quota. The baseline subquotas for each time period are as follows: 29.5 mt for January; 277.9 mt for June through August; 147.3 mt for September; 72.2 mt for October through November; and 28.9 mt for December. Any unused General category quota rolls forward within the fishing year, which coincides with the calendar year, from one time period to the next, and is available for use in subsequent time periods. To date for 2019, NMFS has taken five actions that resulted in adjustments to the Reserve category, leaving 225.3 mt of quota currently available (84 FR 3724, February 13, 2019; 84 FR 6701, February 28, 2019; 84 FR 35340, July 23, 2019; and 84 FR 47440, September 10, 2019).
Under § 635.27(a)(9), NMFS has the authority to transfer quota among fishing categories or subcategories, after considering regulatory determination criteria provided under § 635.27(a)(8). NMFS has considered all of the relevant determination criteria and their applicability to this inseason quota transfer. These considerations include, but are not limited to, the following:
Regarding the usefulness of information obtained from catches in the particular category for biological sampling and monitoring of the status of the stock (§ 635.27(a)(8)(i)), biological samples collected from BFT landed by General category fishermen and provided by bluefin tuna dealers continue to provide valuable data for ongoing scientific studies of bluefin tuna age and growth, migration, and reproductive status. Additional opportunity to land bluefin tuna in the General category would support the continued collection of a broad range of data for these studies and for stock monitoring purposes.
NMFS also considered the catches of the General category quota to date and the likelihood of closure of that segment of the fishery if no adjustment is made (§ 635.27(a)(8)(ii) and (ix)). As of September 10, 2019, the General category landed 134.8 mt. This represents 92 percent of the baseline
Regarding the projected ability of the vessels fishing under the particular category quota (here, the General category) to harvest the additional amount of BFT before the end of the fishing year (§ 635.27(a)(8)(iii)), NMFS anticipates that all of the 60 mt of quota will be used by September 13, based on current figures and the amount of quota being transferred, but this is also subject to weather conditions and bluefin tuna availability. In the unlikely event that any of this quota is unused by September 30, such quota will roll forward to the next subperiod within the calendar year (
NMFS also considered the estimated amounts by which quotas for other gear categories of the fishery might be exceeded (§ 635.27(a)(8)(iv)) and the ability to account for all 2019 landings and dead discards. In the last several years, total U.S. BFT landings have been below the available U.S. quota such that the United States has carried forward the maximum amount of underharvest allowed by ICCAT from one year to the next. NMFS will need to account for 2019 landings and dead discards within the adjusted U.S. quota, consistent with ICCAT recommendations, and anticipates having sufficient quota to do that, even with the 60 mt transfer to the General category for the September fishery. NMFS anticipates that General category participants in all areas and time periods will have opportunities to harvest the General category quota in 2019, through active inseason management such as the timing of quota transfers, as practicable. Thus, this quota transfer would allow fishermen to take advantage of the availability of fish on the fishing grounds to the extent consistent with the available amount of transferrable quota and other management objectives, while avoiding quota exceedance. NMFS also considered the effects of the adjustment on the BFT stock and the effects of the transfer on accomplishing the objectives of the FMP (§ 635.27(a)(8)(v) and (vi)). This transfer would be consistent with the current quotas, which were established and analyzed in the 2018 BFT quota final rule (83 FR 51391, October 11, 2018), and with objectives of the 2006 Consolidated HMS FMP and amendments and is not expected to negatively impact stock health or to affect the stock in ways not already analyzed in those documents. Another principal consideration is the objective of providing opportunities to harvest the full annual U.S. BFT quota without exceeding it based on the goals of the 2006 Consolidated HMS FMP and amendments, including to achieve optimum yield on a continuing basis and to optimize the ability of all permit categories to harvest their full BFT quota allocations (related to § 635.27(a)(8)(x)). Specific to the General category, this includes providing opportunity equitably across all time periods.
Based on the considerations above, NMFS is transferring 60 mt of the available 225.3 mt of Reserve category quota to the General category for the September 2019 fishery, resulting in a subquota of 207.3 mt for the September 2019 fishery and 165.3 mt in the Reserve category.
Based on the best available bluefin tuna General category landings information (
Fishermen may catch and release (or tag and release) BFT of all sizes, subject to the requirements of the catch-and-release and tag-and-release programs at § 635.26. All BFT that are released must be handled in a manner that will maximize their survival, and without removing the fish from the water, consistent with requirements at § 635.21(a)(1). For additional information on safe handling, see the “Careful Catch and Release” brochure available at
NMFS will continue to monitor the BFT fishery closely. Dealers are required to submit landing reports within 24 hours of a dealer receiving BFT. Late reporting by dealers compromises NMFS' ability to timely implement actions such as quota and retention limit adjustment, as well as closures, and may result in enforcement actions. Additionally, and separate from the dealer reporting requirement, General and HMS Charter/Headboat category vessel owners are required to report the catch of all BFT retained or discarded dead within 24 hours of the landing(s) or end of each trip, by accessing
Depending on the level of fishing effort and catch rates of BFT, NMFS may determine that additional action (
The Assistant Administrator for NMFS (AA) finds that it is impracticable
The regulations implementing the 2006 Consolidated HMS FMP and amendments provide for inseason quota transfers and fishery closures to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. These fisheries are currently underway and the currently available quota for the subcategory is projected to be reached shortly. Affording prior notice and opportunity for public comment to implement the quota transfer is impracticable and contrary to the public interest as such a delay would likely result in exceedance of the General category September fishery subquota or earlier closure of the fishery while fish are available on the fishing grounds. Subquota exceedance may result in the need to reduce quota for the General category later in the year and thus could affect later fishing opportunities. Therefore, the AA finds good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment. For all of the above reasons, there also is good cause under 5 U.S.C. 553(d) to waive the 30-day delay in effectiveness.
This action is being taken under §§ 635.27(a)(9) and 635.28(a)(1), and is exempt from review under Executive Order 12866.
16 U.S.C. 971
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to supersede Airworthiness Directive (AD) 2017-19-04 and AD 2014-16-26, which apply to certain Dassault Aviation Model FALCON 900EX airplanes. Those ADs require revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive maintenance requirements and/or airworthiness limitations. Since the FAA issued AD 2017-19-04 and AD 2014-16-26, the FAA determined that new or more restrictive airworthiness limitations are necessary. This proposed AD would require revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by October 31, 2019.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000, South Hackensack, NJ 07606; telephone 201-440-6700; internet
You may examine the AD docket on the internet at
Tom Rodriguez, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3226.
The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
The FAA will post all comments received, without change, to
The FAA issued AD 2017-19-04, Amendment 39-19034 (82 FR 43163, September 14, 2017) (“AD 2017-19-04”), for certain Dassault Aviation Model FALCON 900EX airplanes. AD 2017-19-04 requires revising the existing maintenance or inspection program, as applicable, to incorporate more restrictive airworthiness limitations. AD 2017-19-04 resulted from a determination that more restrictive airworthiness limitations or more restrictive maintenance requirements and/or airworthiness limitations are necessary. The FAA issued AD 2017-19-04 to address reduced structural integrity of the airplane. AD 2017-19-04 specifies that accomplishing the actions required by that AD would terminate the requirements of AD 2014-16-26, Amendment 39-17950 (79 FR 51077, August 27, 2014) (“AD 2014-16-26”), but it did not supersede AD 2014-16-26. In addition, AD 2014-16-26 specifies that accomplishing paragraph (g) of that AD would terminate the requirements of paragraph (g)(1) of AD 2010-26-05, Amendment 39-16544 (75 FR 79952, December 21, 2010); for Dassault Aviation Model FALCON 900EX airplanes, serial numbers 1 through 96 inclusive, and serial numbers 98 through 119 inclusive. This terminating provision of certain requirements of AD 2010-26-05 is included in this proposed AD.
This AD proposes to supersede AD 2017-19-04 and AD 2014-16-26, but does not propose to supersede AD 2010-26-05.
Since AD 2017-19-04 and AD 2014-16-26 were issued, the FAA has determined that new or more restrictive airworthiness limitations are necessary.
The European Union Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2019-0133, dated June 11, 2019 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Dassault Aviation Model FALCON 900EX airplanes. The MCAI states:
The airworthiness limitations for Falcon 900EX aeroplanes, which are approved by EASA, are currently defined and published in Dassault Falcon 900EX AMM [Airplane Maintenance Manual], Chapter 5-40. These instructions have been identified as mandatory for continued airworthiness.
Failure to accomplish these instructions could result in an unsafe condition.
EASA previously issued AD 2016-0128 (which corresponds to FAA AD 2017-19-04), requiring the actions described in Dassault Falcon 900EX AMM Chapter 5-40 (DGT113874) at Revision 14.
Since that [EASA] AD was issued, Dassault published Revisions 15 and 16 of Dassault Falcon 900EX AMM Chapter 5-40 (DGT113874). Revision 16 contains new and/or more restrictive maintenance tasks.
For the reason described above, this [EASA] AD retains the requirements of EASA AD 2016-0128, which is superseded, and requires accomplishment of the actions specified in the ALS [airworthiness limitations section], as defined in this [EASA] AD.
You may examine the MCAI in the AD docket on the internet at
Dassault Aviation has issued Chapter 5-40, Airworthiness Limitations, Revision 16, dated September 2018, of the Dassault FALCON 900EX Maintenance Manual. This service information describes procedures, maintenance tasks, and airworthiness limitations specified in the Airworthiness Limitations section of the AMM.
This proposed AD would also require Chapter 5-40, Airworthiness Limitations, Revision 14, dated November 2015, of the FALCON 900EX Maintenance Manual, which the Director of the Federal Register approved for incorporation by reference as of October 19, 2017 (82 FR 43163, September 14, 2017).
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to a bilateral agreement with the State of Design Authority, the FAA has been notified of the unsafe condition described in the MCAI and service information referenced above. The FAA is proposing this AD because the agency evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop on other products of the same type design.
This proposed AD would retain all requirements of AD 2017-19-04. This proposed AD would require revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations. This proposed AD would also retain the terminating provisions of AD 2014-16-26, related to AD 2010-26-05.
This proposed AD would require revisions to certain operator maintenance documents to include new actions (
The FAA estimates that this proposed AD affects 100 airplanes of U.S. registry.
The FAA estimates the following costs to comply with this proposed AD:
The FAA estimates the total cost per operator for the retained actions from AD 2017-19-04 to be $7,650 (90 work-hours × $85 per work-hour).
The FAA has determined that revising the existing maintenance or inspection program takes an average of 90 work-hours per operator, although the agency recognizes that this number may vary from operator to operator. In the past, the FAA has estimated that this action takes 1 work-hour per airplane. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), the FAA has determined that a per-operator estimate is more accurate than a per-airplane estimate. Therefore, the FAA estimates the total cost per operator for the new proposed actions to be $7,650 (90 work-hours × $85 per work-hour).
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This proposed AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.
The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Will not affect intrastate aviation in Alaska, and
(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
The FAA must receive comments by October 31, 2019.
(1) This AD replaces AD 2014-16-26, Amendment 39-17950 (79 FR 51077, August 27, 2014) (“AD 2014-16-26”); and AD 2017-19-04, Amendment 39-19034 (82 FR 43163, September 14, 2017) (“AD 2017-19-04”).
(2) This AD affects AD 2010-26-05, Amendment 39-16544 (75 FR 79952, December 21, 2010) (“AD 2010-26-05”).
This AD applies to Dassault Aviation Model FALCON 900EX airplanes, certificated in any category, serial numbers 1 through 96 inclusive, and serial numbers 98 through 119 inclusive, certificated in any category.
Air Transport Association (ATA) of America Code 05, Time Limits/Maintenance Checks.
This AD was prompted by a determination that new or more restrictive airworthiness limitations are necessary. The FAA is issuing this AD to address reduced structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
This paragraph restates the requirements of paragraph (g) of AD 2017-19-04, with no changes. Within 90 days after October 19, 2017 (the effective date of AD 2017-19-04), revise the maintenance or inspection program, as applicable, to incorporate the information specified in Chapter 5-40, Airworthiness Limitations, Revision 14, dated November 2015, of the FALCON 900EX Maintenance Manual. The initial compliance time for accomplishing the actions specified in Chapter 5-40, Airworthiness Limitations, Revision 14, dated November 2015, of the FALCON 900EX Maintenance Manual, is within the applicable times specified in the maintenance manual, or 90 days after October 19, 2017, whichever occurs later, except as provided by paragraphs (g)(1) through (4) of this AD.
(1) The term “LDG” in the “First Inspection” column of any table in the service information means total airplane landings.
(2) The term “FH” in the “First Inspection” column of any table in the service information means total flight hours.
(3) The term “FC” in the “First Inspection” column of any table in the service information means total flight cycles.
(4) The term “M” in the “First Inspection” column of any table in the service information means months.
This paragraph restates the requirement specified in paragraph (h) of AD 2017-19-04, with a new exception. Except as required by paragraph (i) of this AD, after accomplishing the revision required by paragraph (g) of this AD, no alternative actions (
Within 90 days after the effective date of this AD, revise the existing maintenance or inspection program, as applicable, to incorporate the information specified in Chapter 5-40, Airworthiness Limitations, Revision 16, dated September 2018, of the Dassault FALCON 900EX Maintenance Manual. The initial compliance time for accomplishing the actions specified in Chapter 5-40, Airworthiness Limitations, Revision 16, dated September 2018, is within the applicable times specified in the maintenance manual, or 90 days after the effective date of this AD, whichever occurs later, except as provided by paragraphs (i)(1) through (4) of this AD.
(1) The term “LDG” in the “First Inspection” column of any table in the service information means total airplane landings.
(2) The term “FH” in the “First Inspection” column of any table in the service information means total flight hours.
(3) The term “FC” in the “First Inspection” column of any table in the service information means total flight cycles.
(4) The term “M” in the “First Inspection” column of any table in the service information means months since the date of issuance of the original airworthiness certificate or the date of issuance of the original export certificate of airworthiness.
After the existing maintenance or inspection program has been revised as required by paragraph (i) of this AD, no alternative actions (
Accomplishing the actions required by paragraph (g) or (i) of this AD terminates the requirements of paragraph (g)(1) of AD 2010-26-05, for Dassault Aviation Model FALCON 900EX airplanes, serial numbers 1 through 96 inclusive, and serial numbers 98 through 119 inclusive.
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2019-0133, dated June 11, 2019, for related information. This MCAI may be found in the AD docket on the internet at
(2) For more information about this AD, contact Tom Rodriguez, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3226.
(3) For service information identified in this AD, contact Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000, South Hackensack, NJ 07606; telephone 201-440-6700; internet
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend the Class E airspace extending upward from 700 feet above the surface at Tomahawk Regional Airport, Tomahawk, WI. The FAA is proposing this action as the result of an airspace review requested by the Airspace Policy Group. The geographic coordinates of the airport would also be updated to coincide with the FAA's aeronautical database. Airspace redesign is necessary for the safety and management of instrument flight rules (IFR) operations at this airport.
Comments must be received on or before October 31, 2019.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone (202) 366-9826, or (800) 647-5527. You must identify FAA Docket No. FAA-2019-0651; Airspace Docket No. 19-AGL-24, at the beginning of your comments. You may also submit comments through the internet at
FAA Order 7400.11D, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Jeffrey Claypool, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5711.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend the Class E airspace extending upward from 700 feet above the surface at Tomahawk Regional Airport, Tomahawk, WI, to support IFR operations at this airport.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2019-0651; Airspace Docket No. 19-AGL-24.” The postcard will be date/time stamped and returned to the commenter.
All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
This document proposes to amend FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019. FAA Order 7400.11D is publicly available as listed in the
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 by amending the Class E airspace extending upward from 700 feet above the surface to of the Tomahawk Regional Airport, Tomahawk, WI, by adding an extension 2 miles each side of the 090° bearing from the airport extending from the 6.4-mile radius to 9.4 miles east of the airport; adding an extension 2 miles each side of the 270° bearing from the airport extending from the 6.4-mile radius to 9 miles west of the airport; and updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database.
This action is necessary due to an airspace review requested by the Airspace Policy Group.
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11D, dated August 8, 2019, and effective September 15, 2019, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 6.4-mile radius of Tomahawk Regional Airport, and within 2 miles each side of the 090° bearing from the airport extending from the 6.4-mile radius to 9.4 miles east the airport, and within 2 miles each side of the 270° bearing extending from the 6.4-mile radius to 9 miles west of the airport.
Environmental Protection Agency (EPA).
Proposed rule.
Pursuant to the Resource Conservation and Recovery Act (RCRA or Act), the Environmental Protection Agency (EPA) is proposing, subject to public comment, to approve revisions to the underground storage tank (UST) program submitted by the State of Georgia (Georgia or State). The EPA has reviewed Georgia's revisions and is proposing to determine that these revisions satisfy all requirements needed for program approval. In addition, the EPA is proposing to codify EPA's approval of Georgia's revised UST program and to incorporate by reference those provisions of the State statutes and regulations the EPA has determined, subject to public comment, meet the requirements for approval. The EPA seeks public comment prior to taking final action.
Comments must be received by October 16, 2019.
Submit your comments, identified by docket number EPA-R04-UST-2019-0310, at
All documents in the docket are listed on the
Aaryn Jones, RCRA Programs and Cleanup Branch, Land, Chemicals and Redevelopment Division, U.S. Environmental Protection Agency, Region 4, Atlanta Federal Center, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960; Phone number: (404) 562-8969; email address:
States that have received final approval from the EPA under RCRA section 9004(b) of RCRA, 42 U.S.C. 6991c(b), must maintain a UST program that is no less stringent than the federal
On August 8, 2018, in accordance with 40 CFR 281.51(a), Georgia submitted a complete program revision application (State Application) seeking approval of changes to its UST program. The program revisions requested in the State Application correspond to the EPA final rule published on July 15, 2015 (80 FR 41566), which revised the 1988 UST regulations and the 1988 state program approval (SPA) regulations (2015 Federal Revisions). As required by 40 CFR 281.20, the State Application contains the following: A transmittal letter from the Governor requesting approval; a description of the program and operating procedures; a demonstration of the State's procedures to ensure adequate enforcement; a Memorandum of Agreement outlining the roles and responsibilities of the EPA and the implementing agency; a statement of certification from the Attorney General; and copies of all relevant State statutes and regulations. The EPA has reviewed the State Application and is proposing to determine that the revisions to Georgia's UST program are no less stringent than the corresponding federal requirements in subpart C of 40 CFR part 281, and that the Georgia program continues to provide adequate enforcement of compliance. Therefore, the EPA is proposing to grant Georgia final approval to operate its UST program with the revisions described in the State Application, and as outlined below in Section I.F. The Environmental Protection Division (EPD) of the Georgia Department of Natural Resources (DNR) is the lead implementing agency for the UST program in Georgia.
Section 9004(b) of RCRA, 42 U.S.C. 6991c(b), as amended, allows the EPA to approve state UST programs to operate in lieu of the federal program. If Georgia is approved for the changes described in the State Application, these changes will become part of the approved State UST program, and therefore will be federally enforceable. Georgia will continue to have primary enforcement authority and responsibility for its State UST program. This action does not impose additional requirements on the regulated community because the regulations being proposed for approval by this rule are already in effect in the State of Georgia, and are not changed by this proposed action. This action merely proposes to approve the existing State regulations as meeting the revised federal requirements and rendering them federally enforceable.
The EPA will evaluate any comments received on this proposed action and will make a final decision on approval or disapproval of the UST program revisions contained in the State Application. The EPA's decision will be published in the
Effective July 9, 1991, the EPA granted final approval for Georgia to administer the State UST program in lieu of the federal UST program (56 FR 21603, May 10, 1991). Effective March 4, 1996, the EPA codified the provisions of the approved Georgia program that are part of the UST program under subtitle I of RCRA, and therefore are subject to the EPA's corrective action, inspection, and enforcement authorities under RCRA sections 9003(h), 9005 and 9006, 42 U.S.C. 6991b(h), 6991d and 6991e, and other applicable statutory and regulatory provisions (61 FR 4224, February 5, 1996).
In order to be approved, each state program revision application must meet the general requirements in 40 CFR 281.11 (General Requirements), and the specific requirements in 40 CFR part 281, subpart B (Components of a Program Application), subpart C (Criteria for No Less Stringent), and subpart D (Adequate Enforcement of Compliance).
As more fully described below, the State has made changes to its approved UST program to reflect the 2015 Federal Revisions. These changes are included in the Georgia UST Rules at Ga. Comp. R. & Regs. 391-3-15, as amended, effective November 6, 2017. The EPA is proposing to approve the State's changes because they are no less stringent than the federal UST program, and because the revised Georgia UST program will continue to provide for adequate enforcement of compliance as required by 40 CFR 281.11(b) and part 281, subparts C and D, after this approval.
The Georgia EPD continues to be the lead implementing agency for the UST program in Georgia. The EPD continues to have broad statutory and regulatory authority to regulate the installation, operation, maintenance, and closure of USTs, as well as UST releases, under the Georgia Underground Storage Tank Act (GUSTA), Official Code of Georgia Annotated (O.C.G.A.) section 12-13-1 (2017), and the Ga. Comp. R. & Regs. 391-3-15 (2017).
As part of the State Application, the Georgia Attorney General has identified the following specific authorities for compliance monitoring, required pursuant to 40 CFR 281.40: GUSTA, O.C.G.A. sections 12-13-6(a)(3), 12-13-8(a), and 12-13-14(b); and Ga. Comp. R. & Regs. r. 391-3-15-.01(2) and 391-3-15-.08.
As part of the State Application, the Georgia Attorney General has identified the following specific authorities for enforcement response, required pursuant to 40 CFR 281.41: GUSTA, O.C.G.A. sections 12-13-15 and 12-13-19(b) and (c); and Ga. Comp. R. & Regs. r. 391-3-15-.14.
As part of the State Application, the Georgia Attorney General has identified the following specific authorities enabling public participation in the State enforcement process, required pursuant to 40 CFR 281.42: O.C.G.A. sections 12-2-2, 50-13-14, 12-13-15, 9-11-24, 12-13-6(a)(8), 12-13-16, and 12-13-21; and Ga. Comp. R. and Regs. r. 391-1-2-.14(2) and 391-3-15-.09. Further, through a Memorandum of Agreement between the State of Georgia and the EPA, effective October 12, 2018, the State maintains procedures for receiving and ensuring proper consideration of information about violations submitted by the public and will not object to public participation in administrative or civil enforcement actions. As required pursuant to 40 CFR 281.43, through the Memorandum of Agreement between the State and the EPA, the State agrees to furnish the EPA, upon request, any information in State files obtained or used in the administration of the State program.
To qualify for final approval, revisions to a state's UST program must be “no less stringent” than the 2015 Federal Revisions. In the 2015 Federal Revisions, the EPA addressed UST
As part of the State Application, and as described above, the Georgia Attorney General has certified that the State regulations provide for adequate enforcement of compliance and meet the “no less stringent” criteria in 40 CFR part 281, subparts C and D. The EPA is relying on this certification, in addition to the analysis submitted by the State, in proposing to approve the State's changes.
Where a state program has provisions that are broader in scope than required by federal law, these provisions are not part of the federally-approved program and are not federally enforceable, in accordance with 40 CFR 281.12(a)(3)(ii). The following State statutory and regulatory requirements are considered broader in scope than the federal and are therefore not part of federally approved State UST program:
• O.C.G.A. section 12-13-9(f)-(i) establishes the Georgia Underground Storage Tank (GUST) Fund to take emergency action, take preventive or corrective action, and provide compensation for third-party liabilities.
• O.C.G.A. section 12-13-10 requires that an environmental assurance fee be paid by any potential claimant to the GUST Fund.
• O.C.G.A section 12-13-11(b) through (e) pertain to the use of the GUST Fund to perform corrective action.
• O.C.G.A. section 12-13-13(e) requires owners and operators of a UST in use or capable of being used to provide an annual UST notification.
• O.C.G.A. section 12-13-18(a) requires owners and operators of USTs to maintain proof that all petroleum stored in such tank was subjected to the environmental fee imposed in O.C.G.A. section 12-13-10.
• Ga. Comp. R. & Regs. r. 391-3-15-.05(4) requires an annual registration of USTs and an annual UST Registration Certificate.
• Ga. Comp. R. & Regs. r. 391-3-15-.09(5) requires that owners or operators may transport or provide for transportation of petroleum-contaminated soils only to permitted storage, treatment or disposal facilities and must designate any receiving facility in the corrective action plan.
• Ga. Comp. R. & Regs. r. 391-3-15-.09(7) allows owners and operators conducting corrective action with funds other than the GUST Fund to remediate soil and groundwater to a more stringent objective than those found in Ga. Comp. R. & Regs. r. 391-3-15-.09(4).
• Ga. Comp. R. & Regs. r. 391-3-15-.13 describes the requirements for owner/operator participation in the GUST Fund, including payment of an Environmental Assurance Fee (EAF) to EPD per gallon of petroleum products imported into Georgia.
When an approved state program includes requirements that are considered more stringent than those required by federal law, the more stringent requirements become part of the federally approved program in accordance with 40 CFR 281.12(a)(3)(i).
The following State regulatory requirements are considered more stringent than the federal program, and on approval, they will become part of the federally-approved State UST program and therefore federally enforceable:
• With respect to the definition of “replaced” found at 40 CFR 280.12, under Ga. Comp. R. & Regs. r. 391-3-15-.03(1)(n), Georgia defines “replace” when referring to piping to mean the removal and replacement of 25% or more of the existing piping.
• With respect to recordkeeping requirements found at 40 CFR 280.34 and 40 CFR 280.45, under Ga. Comp. R. & Regs. r. 391-3-15-.06(2) and 391-3-15-.07(2), Georgia requires records to be maintained for a minimum period of 36 months.
• With respect to release response and corrective action requirements found at 40 CFR part 280, subpart F, the GUST Rule is more stringent as follows:
(1) Under Ga. Comp. R. & Regs. r. 391-3-15-.09(2), Georgia requires that a Corrective Action Plan—Part A be stamped or sealed by a Georgia registered Professional Engineer or Professional Geologist, and submitted in lieu of the initial abatement report, the initial site characterization report, and the free product removal report, as referenced by 40 CFR 280.62(b), 280.63(b), and 280.64(d), respectively, and must be submitted within 60 days after the release confirmation.
(2) Under Ga. Comp. R. & Regs. r. 391-3-15-.09(3), Georgia requires that a Corrective Action Plan—Part B be submitted when certain surface water, groundwater, or soil contamination levels are exceeded, or when the State otherwise determines on a site-specific basis that a Corrective Action Plan—Part B is necessary.
(3) Under Ga. Comp. R. & Regs. r. 391-3-15-.09(4), Georgia requires that if a Corrective Action Plan—Part B is necessary, the full extent of groundwater and surface water contamination must be delineated, and certain corrective action objectives must be proposed and implemented upon approval by the State.
(4) Under Ga. Comp. R. & Regs. r. 391-3-15-.09(6), Georgia requires that the owner or operator certify completion of corrective action in the completion report.
(5) Under Ga. Comp. R. & Reg. r. 391-3-15-.09(8), Georgia requires that determinations of petroleum concentrations in soil or groundwater be performed in conformity with specified methods.
(6) Under Ga. Comp. R. & Regs. r. 391-15-.10, Georgia specifies cleanup levels for releases from hazardous substance USTs.
• With respect to closure requirements found at 40 CFR 280.72, under Ga. Comp. R. & Regs. r. 391-15-.11(3), Georgia requires that owners submit an EPD UST closure report within 45 days of permanently closing a UST.
• With respect to operator training requirements found at 40 CFR 280.244, under Ga. Comp. R. & Regs. r. 391-3-15-.16, Georgia requires owners and operators to complete operator training once every seven years.
Codification is the process of placing citations and references to a state's statutes and regulations that comprise a state's approved UST program into the Code of Federal Regulations (CFR). The EPA codifies its approval of state programs in 40 CFR part 282 and incorporates by reference state statutes and regulations that the EPA can
In 1996, the EPA incorporated by reference and codified Georgia's approved UST program at 40 CFR 282.60 (61 FR 4224, February 5, 1996). Through this action, the EPA is proposing to amend 40 CFR 282.60 to incorporate by reference and codify Georgia's revised UST program.
In this rule, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference of the relevant Georgia UST program, including the revisions made to the program based on the 2015 Federal Revisions. In accordance with the requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference Georgia's statutes and regulations as described in the amendments to 40 CFR part 282 set forth below. These documents are available through
Specifically, in Section 282.60(d)(1)(i), the EPA is proposing to incorporate by reference the Georgia-approved UST program. Section 282.60(d)(1)(ii) identifies the State's statutes and regulations that are part of the approved State program, although not incorporated by reference for enforcement purposes. Section 282.60(d)(2) through (d)(5) reference the Attorney General's Statement, Demonstration of Adequate Enforcement Procedures, the Program Description, and the Memorandum of Agreement, which are part of the State Application and proposed for approval as part of the UST program under subtitle I of RCRA.
The EPA retains the authority under sections 9003(h), 9005, and 9006 of subtitle I of RCRA, 42 U.S.C. 6991b(h), 6991d, and 6991e, and other applicable statutory and regulatory provisions, to undertake corrective action, inspections, and enforcement actions, and to issue orders in approved states. If the EPA determines it will take such actions in Georgia, the EPA will rely on federal sanctions, federal inspection authorities, and other federal procedures rather than the State analogs. Therefore, the EPA is not incorporating by reference Georgia's procedural and enforcement authorities, although they are listed in 40 CFR 282.60(d)(1)(ii).
As discussed in Section I.G. above, some provisions of the State's UST program are not part of the federally approved State program because they are “broader in scope” than the federal UST program. 40 CFR 281.12(a)(3)(ii) states that, where an approved state program has provisions that are broader in scope than the federal program, those provisions are not a part of the federally approved program. As a result, State provisions which are “broader in scope” than the federal program are not incorporated by reference for purposes of enforcement in part 282. In addition, provisions that are external to the State UST program approval requirements, but included in the State Application, are also being excluded from incorporation by reference in part 282. For reference and clarity, 40 CFR 282.60(d)(1)(iii) lists the Georgia statutory and regulatory provisions which are “broader in scope” than the federal program and external to state UST program approval requirements. These provisions are, therefore, not part of the approved program that the EPA is proposing to codify. Although these provisions cannot be enforced by the EPA, the State will continue to implement and enforce such provisions under State law.
The EPA's proposed actions merely approve and codify Georgia's revised UST program requirements pursuant to RCRA section 9004, and do not impose additional requirements other than those imposed by State law. For that reason, these actions:
• Are not significant regulatory actions subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Are not Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory actions because UST program approvals are exempted under Executive Order 12866;
• Do not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Are certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Do not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Do not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Are not economically significant regulatory actions based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Are not significant regulatory actions subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Are not subject to the requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with RCRA; and
• Do not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
• Do not apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. The rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, the EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct.
Environmental protection, Administrative practice and procedure,
This action is issued under the authority of Sections 2002(a), 7004(b), 9004, 9005 and 9006 of the Solid Waste Disposal Act, as amended, 42 U.S.C. 6912(a), 6974(b), 6991c, 6991d, and 6991e.
For the reasons set forth in the preamble, 40 CFR part 282 is proposed to be amended as follows:
42 U.S.C. 6912, 6991c, 6991d, and 6991e.
(a)
(b)
(c) To retain program approval, Georgia must revise its approved program to adopt new changes to the federal subtitle I program which make it more stringent, in accordance with section 9004 of RCRA, 42 U.S.C. 6991c, and 40 CFR part 281, subpart E. If Georgia obtains approval for revised requirements pursuant to section 9004 of RCRA, 42 U.S.C. 6991c, the newly approved statutory and regulatory provisions will be added to this subpart and notice of any change will be published in the
(d) Georgia has final approval for the following elements of its underground storage tank program originally submitted to EPA and approved effective July 9, 1991, and the program revisions approved by EPA effective on [Effective date of final rule]:
(1)
(i)
(A) “Georgia Statutory Requirements Applicable to the UST Program”, dated August 2018.
(B) “Georgia Regulatory Requirements Applicable to the UST Program”, dated August 2018.
(ii)
(A)
(B)
(iii)
(A)
(B)
(2)
(3)
(4)
(5)
(a) The statutory provisions include:
Section 12-13-1 Short title.
Section 12-13-2 Public policy.
Section 12-13-3 Definitions, except (8) and (16).
Section 12-13-4 Exceptions to chapter.
Section 12-13-9 Establishing financial responsibility; claims against the guarantor; Underground Storage Tank Trust Fund, except (d) through (i).
Section 12-13-13 Notification by owner of underground storage tank, except (e).
(b) The regulatory provisions include:
Section 391-3-15-.01(3) General Provisions
Section 391-3-15-.02 UST Exclusions.
Section 391-3-15-.03 Definitions, except (1)(a), (1)(g), (1)(i), and (1)(p) through and (r).
Section 391-3-15-.05 UST Systems: Design, Construction, Installation, and Notification, except (4).
Section 391-3-15-.06 General Operating Requirements.
Section 391-3-15-.07 Release Detection.
Section 391-3-15-.08 Release Reporting, Investigation, and Confirmation.
Section 391-3-15-.09 Release Response and Corrective Action for UST Systems Containing Petroleum, except (5) and (7).
Section 391-3-15-.10 Release Response and Corrective Action for UST Systems Containing Hazardous Substances.
Section 391-3-15-.11 Out-of-Service UST Systems and Closure.
Section 391-3-15-.12 Underground Storage Tanks Containing Petroleum; Financial Responsibility Requirements, except (3).
Section 391-3-15-.16 Operator Training.
Section 391-3-15-.17 Airport Hydrant Systems and Field Constructed Tanks.
(c) Copies of the Georgia statutes that are incorporated by reference are available from LexisNexis, Attn: Official Code of Georgia Annotated, 701 East Water Street, Charlottesville, VA 22902-5389; Phone number: 1-800-833-9844; website:
In proposed rule document 2019-18742 beginning on page 45934 in the issue of Tuesday, September 3, 2019, make the following correction:
The heading should read as set forth above.
The Department of Agriculture has submitted the following information collection requirement(s) to Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. Comments are requested regarding: Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; ways to enhance the quality, utility and clarity of the information to be collected; ways to 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.
Comments regarding this information collection received by October 16, 2019 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725—17th Street NW, Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to:
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding; whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; ways to enhance the quality, utility and clarity of the information to be collected; and ways to 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.
Comments regarding this information collection received by October 16, 2019 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB),
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it
Animal and Plant Health Inspection Service, USDA.
Notice of availability.
We are advising the public that we are proposing to recognize Romania as being free of highly pathogenic avian influenza and Newcastle disease. This proposed recognition is based on a risk evaluation we have prepared in connection with this action, which we are making available for review and comment.
We will consider all comments that we receive on or before November 15, 2019.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
Mr. Javier Vargas, Senior Staff Officer, Regionalization Evaluation Services, Veterinary Services, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737-1231; (301) 851-3316;
The regulations in 9 CFR part 94 (referred to below as the regulations) govern the importation of certain animals and animal products into the United States in order to prevent the introduction of various animal diseases, including highly pathogenic avian influenza (HPAI) and Newcastle disease. Within part 94, § 94.6 contains requirements governing the importation of carcasses, meat, parts or products of carcasses, and eggs (other than hatching eggs) of poultry, game birds, or other birds from regions where HPAI and Newcastle disease is considered to exist.
In accordance with § 94.6(a)(1)(i) the Animal and Plant Health Inspection Service (APHIS) maintains a list of regions in which Newcastle disease is not considered to exist. Paragraph (a)(1)(ii) states that APHIS will add a region to this list after it conducts an evaluation of the region and finds that Newcastle disease is not likely to be present in its commercial bird or poultry populations.
In accordance with § 94.6(a)(2)(i), APHIS maintains a list of regions in which HPAI is considered to exist. Paragraph (a)(2)(ii) states that APHIS will remove a region from this list only after it conducts an evaluation of the region and finds that HPAI is not likely to be present in its commercial bird or poultry populations.
The regulations in 9 CFR part 92, § 92.2, contain requirements for requesting the recognition of the animal health status of a region (as well as for the approval of the export of a particular type of animal or animal product to the United States from a foreign region). If, after review and evaluation of the information submitted in support of the request, APHIS believes the request can be safely granted, APHIS will make its evaluation available for public comment through a document published in the
The Government of Romania has requested that APHIS evaluate the HPAI and Newcastle disease status of the country. In response to Romania's request, we have prepared an evaluation, titled “APHIS Evaluation of the Highly Pathogenic Avian Influenza and Newcastle Disease Status of Romania” (May 2019). Based on this evaluation, we have determined that Romania's domestic poultry populations are currently free of both HPAI and Newcastle disease as defined in 9 CFR 94.0. APHIS acknowledges the continuing risk posed by wild birds in Romania and the European Union (EU); however, Romania's competent veterinary authority takes effective prevention and control measures minimizing the risk of introduction to commercial poultry, and these are sufficient to minimize the likelihood of
APHIS also concludes that Romania meets the requirements to form part of the EU Poultry Trade Region (EUPTR), an APHIS-recognized region of the EU that meets APHIS requirements for being considered free of HPAI and Newcastle disease, and for which the importation of live birds and poultry and poultry meat and products is harmonized.
Therefore, in accordance with § 92.2(e), we are announcing the availability of our risk evaluation of the HPAI and Newcastle disease status of Romania for public review and comment.
In April 2012, APHIS prepared an environmental assessment (EA) analyzing the potential effects on the human environment from listing the 25 Member States that constituted the EU in 2006 as a region free of HPAI and Newcastle disease (collectively referred to as EUPTR). The EA has been prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321
The evaluation and EA may be viewed on the
Information submitted in support of Romania's request is available by contacting the person listed under
After reviewing any comments we receive, we will announce our decision regarding the disease status of Romania with respect to HPAI and Newcastle disease in a subsequent notice.
7 U.S.C. 1633, 7701-7772, 7781-7786, and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
Animal and Plant Health Inspection Service, USDA.
Notice of meeting; correction.
We are correcting an error in a notice published in the
The meeting will still begin at 8 a.m. and end at 5 p.m. on September 18 and 19, 2019.
Ms. Carrie Joyce, Designated Federal Officer, Wildlife Services, APHIS, 4700 River Road, Unit 87, Riverdale, MD 20737; (301) 851-3999.
In a notice published in the
Attendees should arrive between 7:30 and 8 a.m.
Forest Service, USDA.
Notice of proposed new fee sites; comment request.
The Lolo National Forest is proposing to charge new fees at four day-use sites, three recreation rental facilities and seven campgrounds across the Forest as described in the supplementary section of this notice.
All sites have had recent upgrades and new or improved amenities added to improve the services and recreation experiences. The Driveway Peak lookout is being moved from its current location on Priscilla Peak to a more accessible location on Driveway Peak. Fees are assessed based on the level of amenities and services provided, cost of operation and maintenance, market assessment, and public comment. Funds from these fees will be used for continued operation, maintenance and capital improvements to these recreation sites. These new fees would align the sites with other sites offering similar amenities and services. These fees are only proposed and will be determined upon further analysis and public comment.
Send any comments about these fee proposals by October 16, 2019, comments will be compiled, analyzed, and shared with the Recreation Resource Advisory Council(s). The proposed fees will become available pending a recommendation from the Resource Advisory Committee. If approved by the Regional Forester, the Forest Service will implement the new fee changes in 2020.
Written comments concerning this notice should be addressed to the Supervisor's Office: Lolo National Forest, Attn: Recreation Fee Proposals, 24 Fort Missoula Road, Missoula, MT 59804.
Kate Jerman, Public Affairs Officer, 406-329-1024 or by email at
The Federal Recreation Lands Enhancement Act (Title VII, Pub. L. 108-447) directed the Secretary of Agriculture to publish a six month advance notice in the
Once public involvement is complete, these new fees will be reviewed by the Resource Advisory Council(s) prior to a final decision and implementation.
Specifically, the Lolo National Forest is proposing the following new fees:
• Big Hole Lookout; proposed fee of $45 per night;
• Driveway Peak Lookout; proposed fee of $55 per night;
• Savenac East Cottage; proposed fee of $80 per night;
• Seeley Lake and Big Larch Day Use Areas/Boat Launches; proposed fee of $5 per vehicle, per day; or a $35 annual pass;
• Pattee Canyon and Seeley Creek Winter trail complexes; proposed fee of $5 per vehicle, per day; or a $35 annual pass;
• Big Horn, Big Nelson, Fishtrap Lake, Kreis Pond, Lake Inez, Little Joe and Siria campgrounds; proposed fee of $10 per night, with an additional $5 extra vehicle fee per night for more than two vehicles.
• Big Horn, Big Nelson, Fishtrap Lake, Kreis Pond, Lake Inez, Little Joe and Siria campgrounds; proposed fee of $10 per night, with an additional $5 extra vehicle fee per night for more than two vehicles.
Fees, paid by users of these sites and services, will help ensure that the Forest can continue maintaining and improving the sites for future generations. A market analysis of surrounding recreation sites with similar amenities indicates that the proposed fees are comparable and reasonable.
Advance reservations for the Big Hole and Driveway Peak Lookouts, and Savenac East Cottage will be available through
U.S. Census Bureau, Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
To ensure consideration, written comments must be submitted on or before November 15, 2019.
Direct all written comments to Michael Berning, Assistant Division Chief for Data Acquisition and Curation, U.S. Census Bureau, 4600 Silver Hill Road, Room 5H151, Washington, DC 20233 (or via the internet at
Requests for additional information or copies of the information collection instrument(s) and instructions should be directed to Michael Berning, U.S. Census Bureau, 4600 Silver Hill Road, Room 5H151, Washington, DC 20233-8400 at (301) 763-2028.
The U.S. Census Bureau plans to request a general clearance for acquiring State administrative records in order to improve efficiency and accuracy in our data collections, and to improve measures of the population and economy. The records to be acquired are person-level program participating records that will be used to support the decennial census program as well as for research topics that includes eligibility analyses. The Census Bureau has undertaken research projects to integrate and link State administrative records with Census Bureau data from current surveys and censuses.
The Census Bureau uses the State administrative records linked with other survey and census records to conduct further research and improve operations with surveys and censuses, including 2020 Census Operations. The Census Bureau benefits from these projects by improving data quality and estimates, as well as studies of program participation over time. State data providers have benefited through access to tabulated data and reports to better understand the demographic characteristics of program participants and to administer their programs.
The Census Bureau will contact the State agencies to discuss how the Census Bureau might use of State administrative records. After entering into a data sharing agreement with the Census Bureau, a State agency would transfer the agreed-upon administrative records to the Census Bureau via secure File Transfer Protocol or encrypted CD-ROM or DVD-ROM.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection;
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminary determines that a producer/exporter of steel concrete reinforcing bar (rebar) from the Republic of Turkey (Turkey) received countervailable subsidies during the period of review (POR) March 1, 2017 through December 31, 2017. Interested parties are invited to comment on these preliminary results.
Applicable September 16, 2019.
Kathryn Turlo, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3870.
On September 10, 2018, Commerce published a notice of initiation of an administrative review of the countervailing duty (CVD) order on rebar from Turkey.
On January 28, 2019, Commerce exercised its discretion to toll all deadlines affected by the partial federal government closure from December 22, 2018 through the resumption of operations on January 29, 2019.
The merchandise covered by the order is rebar from Turkey. For a complete description of the scope,
Commerce is conducting this administrative review in accordance with section 751(a)(1)(A) of the Tariff Act of 1930, as amended (the Act). For each subsidy program found countervailable, we preliminarily find that there is a subsidy,
Commerce calculated an individual estimated countervailable subsidy rate for Habas, the only individually examined exporter/producer in this review, for the period March 1, 2017 through December 31, 2017, as follows:
Consistent with section 751(a)(2)(C) of the Act, upon issuance of the final results, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, countervailing duties on all appropriate entries covered by this review. We intend to issue instructions to CBP 15 days after publication of the final results of this review.
Pursuant to section 751(a)(1) of the Act, Commerce intends to instruct CBP to collect cash deposits of estimated countervailing duties in the amount indicated above for the reviewed companies, with regard to shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this review. For all other firms, we will instruct CBP to collect cash deposits at the most recent company-specific or all-others rate applicable to the company, as appropriate. These cash deposit requirements, when imposed, shall remain in effect until further notice.
We will disclose to the parties in this proceeding the calculations performed in reaching the preliminary results within five days of the date of publication of this notice.
Interested parties who wish to request a hearing, or to participate if one is requested, must submit a written request within 30 days after the date of publication of this notice.
Parties are reminded that briefs and hearing requests are to be filed electronically using ACCESS and received successfully in their entirety by 5:00 p.m. Eastern Time on the due date.
Unless the deadline is extended pursuant to section 751(a)(3)(A) of the Act, Commerce intends to issue the final results of this administrative review, including the results of our analysis of the issues raised by parties in their comments, within 120 days after publication of these preliminary results.
These preliminary results of review are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213 and 351.221(b)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Based on affirmative final determinations by the Department of Commerce (Commerce) and the International Trade Commission (ITC), Commerce is issuing the antidumping duty (AD) and countervailing duty (CVD) orders on certain steel racks and parts thereof (steel racks) from the People's Republic of China (China). In addition, Commerce is amending its final determination of sales at less than fair value (LTFV) to correct ministerial errors.
Applicable September 16, 2019.
Maliha Khan (AD) or Robert Galantucci (CVD), AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0895 and (202) 482-2923, respectively.
In accordance with sections 735(d) and 705(d) of the Tariff Act of 1930, as amended (the Act), on July 24, 2019, Commerce published its affirmative final determination of sales at LTFV
On September 9, 2019, the ITC notified Commerce of its final affirmative determination that an industry in the United States is materially injured by reason of LTFV imports and subsidized imports of steel racks from China, within the meaning of sections 735(b)(1)(A)(i) and 705(b)(1)(A)(i) of the Act.
The products covered by these orders are steel racks from China. For a complete description of the scope of the orders,
Pursuant to sections 735(e) of the Act and 19 CFR 351.224(e) and (f), Commerce is amending the
In the
On September 9, 2019, in accordance with section 735(d) of the Act, the ITC notified Commerce of its final determination that an industry in the United States is materially injured within the meaning of section 735(b)(1)(A)(i) of the Act by reason of imports of steel racks from China that are sold in the United States at LTFV.
As a result of the ITC's final determination, in accordance with section 736(a)(1) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to assess, upon further instruction by Commerce, antidumping duties equal to the amount by which the normal value of the merchandise exceeds the export price or constructed export price of the subject merchandise, for all relevant entries of steel racks from China. Antidumping duties will be assessed on unliquidated entries of steel racks from China entered, or withdrawn from warehouse, for consumption on or after March 4, 2019, the date of publication of the
Except as noted in the “Provisional Measures—AD” section of this notice below, in accordance with section 735(c)(1)(B) of the Act, Commerce will instruct CBP to continue to suspend liquidation on all relevant entries of steel racks from China. These instructions suspending liquidation will remain in effect until further notice.
Commerce will also instruct CBP to require cash deposits equal to the estimated weighted-average dumping margins indicated in the table below. Given that the provisional measures period has expired, as explained below, effective on the date of publication in the
Section 733(d) of the Act states that suspension of liquidation pursuant to an affirmative preliminary determination may not remain in effect for more than four months, except where exporters representing a significant proportion of exports of the subject merchandise request that Commerce extend the four-month period to no more than six months. At the request of exporters that account for a significant proportion of steel racks from China, Commerce extended the four-month period to six months in this proceeding. Commerce published the preliminary determination on March 4, 2019. Hence, the extended provisional measures period, beginning on the date of publication of the preliminary determination, ended on August 30, 2019.
Therefore, in accordance with section 733(d) of the Act and our practice,
The estimated weighted-average dumping margin percentages are as follows:
On September 9, 2019, in accordance with sections 705(b)(1)(A)(i) and 705(d) of the Act, the ITC notified Commerce of its final determination that an industry in the United States is materially injured by reason of subsidized imports of steel racks from China.
As a result of the ITC's final affirmative determination, in accordance with section 706(a) of the Act, Commerce will direct CBP to assess, upon further instruction by Commerce, countervailing duties on unliquidated entries of steel racks from China entered, or withdrawn from warehouse, for consumption on or after December 3, 2018, the date of publication of the
In accordance with section 706 of the Act, we will instruct CBP to reinstitute suspension of liquidation on all relevant entries of subject merchandise (
These instructions suspending liquidation will remain in effect until further notice. The all-others rate applies to all producers or exporters not specifically listed. The estimated subsidy rates for the countervailing duty order are as follows:
Section 703(d) of the Act states that suspension of liquidation instructions issued pursuant to an affirmative preliminary determination may not remain in effect for more than four months. Commerce published its
Therefore, in accordance with section 703(d) of the Act, Commerce instructed CBP to terminate the suspension of liquidation and to liquidate, without regard to countervailing duties, unliquidated entries of steel racks from China entered, or withdrawn from warehouse, for consumption on or after April 2, 2019, the date on which provisional measures expired, through the day preceding the date of publication of the ITC's final affirmative injury determinations in the
This notice constitutes the AD and CVD orders with respect to steel racks from China pursuant to sections 736(a) and 706(a) of the Act. Interested parties can find a list of orders currently in effect at
These orders are published in accordance with sections 706(a) and 736(a) of the Act and 19 CFR 351.211(b).
The merchandise covered by these orders is steel racks and parts thereof, assembled, to any extent, or unassembled, including but not limited to, vertical components (
Subject steel racks and parts thereof are made of steel, including, but not limited to, cold and/or hot-formed steel, regardless of the type of steel used to produce the components and may, or may not, include locking tabs, slots, or bolted, clamped, or welded connections. Subject steel racks have the following physical characteristics:
(1) Each steel vertical and horizontal load bearing member (
(2) Each steel vertical and horizontal load bearing member (
(3) The width of each steel vertical load bearing member (
(4) The overall depth of each steel roll-formed horizontal load bearing member (
In the case of steel horizontal load bearing members other than roll-formed (
Steel rack components can be assembled into structures of various dimensions and configurations by welding, bolting, clipping, or with the use of devices such as clips, end plates, and beam connectors, including, but not limited to the following configurations: (1) Racks with upright frames perpendicular to the aisles that are independently adjustable, with positive-locking beams parallel to the aisle spanning the upright frames with braces; and (2) cantilever racks with vertical components parallel to the aisle and cantilever beams or arms connected to the vertical components perpendicular to the aisle. Steel racks may be referred to as pallet racks, storage racks, stacker racks, retail racks, pick modules, selective racks, or cantilever racks and may incorporate moving components and be referred to as pallet-flow racks, carton-flow racks, push-back racks, movable-shelf racks, drive-in racks, and drive-through racks. While steel racks may be made to ANSI MH16.l or ANSI MH16.3 standards, all steel racks and parts thereof meeting the description set out herein are covered by the scope of these orders, whether or not produced according to a particular standard.
The scope includes all steel racks and parts thereof meeting the description above, regardless of
(1) other dimensions, weight, or load rating;
(2) vertical components or frame type (including structural, roll-form, or other);
(3) horizontal support or beam/brace type (including but not limited to structural, roll-form, slotted, unslotted, Z-beam, C-beam, L-beam, step beam, and cantilever beam);
(4) number of supports;
(5) number of levels;
(6) surface coating, if any (including but not limited to paint, epoxy, powder coating, zinc, or other metallic coatings);
(7) rack shape (including but not limited to rectangular, square, corner, and cantilever);
(8) the method by which the vertical and horizontal supports connect (including but not limited to locking tabs or slots, bolting, clamping, and welding); and
(9) whether or not the steel rack has moving components (including but not limited to rails, wheels, rollers, tracks, channels, carts, and conveyors).
Subject merchandise includes merchandise matching the above description that has been finished or packaged in a third country. Finishing includes, but is not limited to, coating, painting, or assembly, including attaching the merchandise to another product, or any other finishing or assembly operation that would not remove the
Steel racks and parts thereof are included in the scope of these orders whether or not imported attached to, or included with, other parts or accessories such as wire decking, nuts, and bolts. If steel racks and parts thereof are imported attached to, or included with, such non-subject merchandise, only the steel racks and parts thereof are included in the scope.
The scope of these orders does not cover: (1) Decks,
Specifically excluded from the scope of these orders are any products covered by Commerce's existing antidumping and countervailing duty orders on boltless steel shelving units prepackaged for sale from the People's Republic of China.
Also excluded from the scope of these orders are bulk-packed parts or components of boltless steel shelving units that were specifically excluded from the scope of the Boltless Steel Shelving Orders because such bulk-packed parts or components do not contain the steel vertical supports (
Such excluded components of boltless steel shelving are defined as:
(1) Boltless horizontal supports (beams, braces) that have each of the following characteristics: (a) A length of 95 inches or less, (b) made from steel that has a thickness of 0.068 inches or less, and (c) a weight capacity that does not exceed 2,500 lbs per pair of beams for beams that are 78″ or shorter, a weight capacity that does not exceed 2,200 lbs per pair of beams for beams that are over 78″ long but not longer than 90″, and/or a weight capacity that does not exceed 1,800 lbs per pair of beams for beams that are longer than 90″;
(2) shelf supports that mate with the aforementioned horizontal supports; and
(3) boltless vertical supports (upright welded frames and posts) that have each of the following characteristics: (a) A length of 95 inches or less, (b) with no face that exceeds 2.90 inches wide, and (c) made from steel that has a thickness of 0.065 inches or less.
Excluded from the scope of these orders are: (1) Wall-mounted shelving and racks, defined as shelving and racks that suspend all of the load from the wall, and do not stand on, or transfer load to, the floor; (2) ceiling-mounted shelving and racks, defined as shelving and racks that suspend all of the load from the ceiling and do not stand on, or transfer load to, the floor; and (3) wall/ceiling mounted shelving and racks, defined as shelving and racks that suspend the load from the ceiling and the wall and do not stand on, or transfer load to, the floor. The addition of a wall or ceiling bracket or other device to attach otherwise subject merchandise to a wall or ceiling does not meet the terms of this exclusion.
Also excluded from the scope of these orders is scaffolding that complies with ANSI/ASSE A10.8—2011—Scaffolding Safety Requirements, CAN/CSA S269.2-M87 (Reaffirmed 2003)—Access Scaffolding for Construction Purposes, and/or Occupational Safety and Health Administration regulations at 29 CFR part 1926 subpart L—Scaffolds.
Also excluded from the scope of these orders are tubular racks such as garment racks and drying racks,
Also excluded from the scope of these orders are portable tier racks. Portable tier racks must meet each of the following criteria to qualify for this exclusion:
(1) They are freestanding, portable assemblies with a fully welded base and four freely inserted and easily removable corner posts;
(2) They are assembled without the use of bolts, braces, anchors, brackets, clips, attachments, or connectors;
(3) One assembly may be stacked on top of another without applying any additional load to the product being stored on each assembly, but individual portable tier racks are not securely attached to one another to provide interaction or interdependence; and
(4) The assemblies have no mechanism (
Also excluded from the scope of these orders are accessories that are independently bolted to the floor and not attached to the rack system itself,
Merchandise covered by these orders is currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under the following subheadings: 7326.90.8688, 9403.20.0081 and 9403.90.8041. Subject merchandise may also enter under subheadings 7308.90.3000, 7308.90.6000, 7308.90.9590, and 9403.20.0090. The HTSUS subheadings are provided for convenience and U.S. Customs purposes only. The written description of the scope is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily finds that exporters of steel concrete reinforcing bar (rebar) from the Republic of Turkey (Turkey) sold subject merchandise in the United States at prices below normal value during the period of review (POR) March 7, 2017 through June 30, 2018. We invite all interested parties to comment on these preliminary results.
Applicable September 16, 2019.
Kathryn Wallace and Thomas Dunne, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-6251 and (202) 482-2328, respectively.
Commerce is conducting an administrative review of the antidumping duty order on rebar from Turkey in accordance with section 751(a)(1)(B) of Tariff Act of 1930, as amended (the Act).
The product covered by the
Commerce is conducting this review in accordance with section 751 of the Act. Export price is calculated in accordance with section 772 of the Act. Normal value is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying the preliminary results,
The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
As a result of this review, we calculated a preliminary weighted-average dumping margin of 0.91 percent for Kaptan Demir and 1.57 for Icdas for the POR. Commerce calculated the rate for the companies not selected for individual examination using a weighted-average of the estimated weighted-average dumping margins calculated for Icdas and Kaptan Demir and each company's publicly-ranged values for the merchandise under consideration.
Upon issuance of the final results, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review. For any individually examined respondents whose weighted-average dumping margin is above
In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by Kaptan Demir and Icdas for which each company did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate those entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction. We intend to issue instructions to CBP 15 days after the publication date of the final results of this review.
The following deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for the companies under review will be the rate established in the final results of this review (except, if the
These cash deposit requirements, when imposed, shall remain in effect until further notice.
Commerce intends to disclose its calculations and analysis performed within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). Pursuant to 19 CFR 351.309(c)(1)(ii), interested parties will have the opportunity to comment on the preliminary results and may submit case briefs and/or written comments at a date to be determined in a memorandum following the issuance of the preliminary results. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS. An electronically-filed document must be received successfully in its entirety by ACCESS by 5:00 p.m. Eastern Time within 30 days after the date of publication of this notice. Requests should contain: (1) The party's name, address, and telephone number; (2) the number of participants; (3) whether any participant is a foreign national; and (4) a list of issues parties intend to discuss. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs.
Unless otherwise extended, Commerce intends to issue the final results of this administrative review, which will include the results of its analysis of issues raised in any briefs, within 120 days of publication of these preliminary results, pursuant to section 751(a)(3)(A) of the Act.
This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.
The preliminary results of review are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(4).
International Trade Administration, Department of Commerce.
The United States Department of Commerce, International Trade Administration (ITA) is announcing five upcoming trade missions that will be recruited, organized, and implemented by ITA. These missions are:
• Additive Manufacturing Trade Mission to Europe—November 17-22, 2019.
• Envirotech Executive Service Mission to India—February 9-15, 2020.
• Asia EDGE Trade Mission to Southeast Asia—March 16-20, 2020.
• Trade Winds Indo Pacific Hong Kong & Indo Pacific Region—April 20-28, 2020.
A summary of each mission is found below. Application information and more detailed mission information, including the commercial setting and sector information, can be found at the trade mission website:
For each mission, recruitment will be conducted in an open and public manner, including publication in the
Gemal Brangman, Trade Promotion Programs, Industry and Analysis, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington DC 20230, telephone (202) 482-3773.
Applicants must submit a completed and signed mission application and supplemental application materials, including adequate information on their products and/or services, primary market objectives, and goals for participation. If the Department of Commerce receives an incomplete application, the Department may either: reject the application, request additional information/clarification, or take the lack of information into account when evaluating the application. If the requisite minimum number of participants is not selected for a particular mission by the recruitment deadline, the mission may be cancelled.
Each applicant must also certify that the products and services it seeks to export through the mission are either produced in the United States, or, if not,
A trade association/organization applicant must certify to the above for all of the companies it seeks to represent on the mission.
In addition, each applicant must:
• Certify that the products and services that it wishes to market through the mission would be in compliance with U.S. export controls and regulations;
• Certify that it has identified any matter pending before any bureau or office in the Department of Commerce;
• Certify that it has identified any pending litigation (including any administrative proceedings) to which it is a party that involves the Department of Commerce; and
• Sign and submit an agreement that it and its affiliates (1) have not and will not engage in the bribery of foreign officials in connection with a company's/participant's involvement in this mission, and (2) maintain and enforce a policy that prohibits the bribery of foreign officials.
In the case of a trade association/organization, the applicant must certify that each firm or service provider to be represented by the association/organization can make the above certifications.
Targeted mission participants are U.S. firms, services providers and trade associations/organizations providing or promoting U.S. products and services that have an interest in entering or expanding their business in the mission's destination country. The following criteria will be evaluated in selecting participants:
• Suitability of the applicant's (or in the case of a trade association/organization, represented firm's or service provider's) products or services to these markets;
• The applicant's (or in the case of a trade association/organization, represented firm's or service provider's) potential for business in the markets, including likelihood of exports resulting from the mission; and
• Consistency of the applicant's (or in the case of a trade association/organization, represented firm's or service provider's) goals and objectives with the stated scope of the mission.
Balance of company size and location may also be considered during the review process. Referrals from a political party or partisan political group or any information, including on the application, containing references to political contributions or other partisan political activities will be excluded from the application and will not be considered during the selection process. The sender will be notified of these exclusions.
If and when an applicant is selected to participate on a particular mission, a payment to the Department of Commerce in the amount of the designated participation fee below is required. Upon notification of acceptance to participate, those selected have 5 business days to submit payment or the acceptance may be revoked.
Participants selected for a trade mission will be expected to pay for the cost of personal expenses, including, but not limited to, international travel, lodging, meals, transportation, communication, and incidentals, unless otherwise noted. Participants will, however, be able to take advantage of U.S. Government rates for hotel rooms. In the event that a mission is cancelled, no personal expenses paid in anticipation of a mission will be reimbursed. However, participation fees for a cancelled mission will be reimbursed to the extent they have not already been expended in anticipation of the mission.
If a visa is required to travel on a particular mission, applying for and obtaining such a visa will be the responsibility of the mission participant. Government fees and processing expenses to obtain such a visa are not included in the participation fee. However, the Department of Commerce will provide instructions to each participant on the procedures required to obtain business visas.
Trade Mission members participate in trade missions and undertake mission-related travel at their own risk. The nature of the security situation in a given foreign market at a given time cannot be guaranteed. The U.S. Government does not make any representations or guarantees as to the safety or security of participants. The U.S. Department of State issues U.S. Government international travel alerts and warnings for U.S. citizens available at
For purposes of assessing participation fees, an applicant is a small or medium-sized enterprise (SME) if it qualifies under the Small Business Administration's (SBA) size standards (
The United States (U.S.) Department of Commerce, International Trade Administration's Foreign Commercial Service (USFCS), along with assistance from ITA's Industry & Analysis unit, are organizing an Additive Manufacturing (AM) Trade Mission to France, Germany, and Poland, November 18-22. This mission is designed to help export-ready U.S. companies launch or increase their export business in the rapidly advancing AM and 3D printing industries of France, Germany, and Poland.
Mission participants will benefit from expert briefings, provided by public and private sector specialists, on each country's commercial framework and the local AM market. Strategic focus on AM development, Research & Development (R&D), and commercial integration will be included in the briefings to emphasize American standards and increase competitiveness. The agenda in France and Poland includes meetings with local AM stakeholders, professional associations, one-on-one meetings with potential business partners, and onsite visits with industry leaders. In Germany, delegates will attend the Formnext trade show where they will have the opportunity to participate in discussions on AM standardization, promote their products via a “Pitch Fest”, and network with international buyers and stakeholders also attending or exhibiting the show.
The mission will include occur over five business days and involve stops in four cities; Paris, France, Frankfurt, Germany, and Warsaw and Rzeszow,
All parties interested in participating in the trade mission must submit a complete application for consideration by the U.S. Department of Commerce. All applicants will be evaluated on their market potential and objectives as they relate to the mission stops. The mission will be open on a rolling basis to a minimum of eight and a maximum of 15 firms. Companies must meet the 51% US content rule and eligibility guidelines.
Upon review of an application and acceptance to participate, a payment to the U.S. Department of Commerce in the form of a participation fee is required. The participation fee for the Business Development Mission will be $3,995 for small or medium-sized enterprises (SME); and $7,750 for large firms or trade associations. The fee for each additional firm representative (large firm or SME/trade organization) is $700. Expenses for travel, lodging, meals, and incidentals will be the responsibility of each mission participant. Post in Germany has coordinated with the FormNext show organizer to allow participants entry to its show. Interpreter and driver services can be arranged for an additional cost. Delegation members will be able to take advantage of U.S. Embassy rates for hotel rooms. More detailed travel information and recommended providers will be provided once a company has confirmed participation.
Mission recruitment will be conducted in an open and public manner, including publication in the
The United States Department of Commerce, International Trade Administration, U.S. Commercial Service is organizing the “Envirotech Executive Service” (EES) Mission—Water Delegation to India from February 9-15, 2020, with optional spin-off Gold Key Service in Mumbai or Hyderabad on February 17, 2020.
The “Envirotech Executive Service” (EES) Water Delegation to India is intended to include representatives from up to six U.S. water/wastewater industry manufacturers, service providers, associations, or trade organizations. The EES will introduce the participants to government service providers, end-users and prospective partners whose needs and capabilities are best suited to each U.S. participant's strengths. Participating in an official U.S. industry delegation, rather than traveling to India on their own, will enhance the participants' ability to secure business and government meetings in India. The business meetings will be designed to match the delegates with potential business partners, distributors or importers in India. The delegates will meet with government officials to obtain first-hand information about the regulations, policies and procedures for importing into and doing business in India. Participants will also visit facilities to get acquainted with the environmental water/wastewater sector in India. The mission will include appointments and briefings in Delhi, Ahmedabad and Chennai, as well as the opportunity to visit/participate in a local trade show Water Expo 2020 in Chennai. After completion of the EES, delegates can opt for a day of additional Gold Key Service matchmaking meetings in Mumbai or Hyderabad. Each city is one of India's major water industry hubs. Trade mission participants will have the opportunity to interact extensively with Embassy/Consulate Officials and
Mission participants are encouraged to arrive on Sunday, February 9, 2020 before the mission program begins on Monday, February 10, 2020.
All parties interested in participating in the EES to India must complete and submit an application for consideration by the Department of Commerce. All applicants will be evaluated on their ability to meet certain conditions and best satisfy the selection criteria as outlined below. A minimum of 4 and a maximum of 6 companies will be selected to participate in the EES from the applicant pool. U.S. companies already doing business in India as well as U.S. companies seeking to enter the Indian market for the first time may apply.
After a company or organization has been selected to participate on the mission, a payment to the Department of Commerce in the form of a participation fee is required.
The participation fee for the three-city (New Delhi, Ahmedabad and Chennai) Trade Mission will be $3,460.00 for one principal representative from a small or medium-sized enterprise (SME), or trade organization and $5,090.00 for large firms. The fee for each additional representative (large firm or SME/trade organization) is $750.00. The participant fee includes entry to the local trade show Water Expo 2020 in Chennai. Expenses for lodging, some meals, incidentals, and all travel (except for transportation to and from airports in-country, previously noted) will be the responsibility of each mission participant. Additional Gold Key Service matchmaking meetings in Mumbai or Hyderabad will cost $950 for a small company, $2,300 for a medium sized company and $3,400 for a large company.
Mission recruitment will be conducted in an open and public manner, including publication in the
Recruitment for the mission will begin immediately and conclude no later than December 6, 2019. The U.S. Department of Commerce will review applications and make selection decisions on a rolling basis. We will inform all applicants of selection decisions as soon as possible after the applications are reviewed. Applications received after the December 6, 2019 deadline will be considered only if space and scheduling constraints permit.
The United States Department of Commerce, International Trade Administration (ITA), is organizing an executive-led Business Development Mission to Southeast Asia, with stops in Indonesia (Jakarta) and Vietnam (Ho Chi Minh City and Hanoi) and an optional program in Thailand (Bangkok).
This trade mission will be the first organized under the Asia Enhancing Development and Economic Growth through Energy (Asia EDGE) initiative. Launched in July 2018 to support the Trump Administration's vision for the Indo-Pacific region, Asia EDGE is a U.S. whole-of-government effort to grow sustainable and secure energy markets throughout Asia by promoting U.S. exports, mobilizing private sector investment, removing trade barriers, and strengthening standards and procurement practices. Drawing on expertise and resources from across the U.S. government, this trade mission will advance the Asia EDGE strategic objective of improving free, fair, and reciprocal energy trading relationships. In addition, the mission will build on several existing energy programs and events, including those organized under the U.S.-Indonesia Power Working Group and the U.S.-Vietnam Energy Working Group.
Mission participants will have the opportunity to meet with key Southeast Asian decision makers to discuss how to foster policies, regulations, and financial investment that support the development of sustainable, secure, and profitable energy markets. Mission participants will network with regional government officials, be introduced to prospective business partners, and facilitate discussions on best practices in their areas of technical expertise.
Applicants must sign and submit a completed trade mission application form and satisfy all the conditions of participation to be eligible for consideration. ITA plans to select a minimum of 10 and a maximum of 15 firms and/or trade associations to participate in the mission.
After a firm or trade association has been selected to participate on the mission, a payment to the U.S. Department of Commerce in the form of a participation fee is required. The participation fee for this Business Development Mission will be $4,000 for small or medium-sized enterprises (SME); and $6,200 for large firms or trade associations. The fee for each additional firm representative (large firm, SME or trade association) is $1,000. The fee for the spin-off to Bangkok will be $1,500 for SME; and $2,400 for large firms or trade associations.
Mission recruitment will be conducted in an open and public manner, including publication in the
The Department of Commerce will evaluate applications and inform applicants of selection decisions twice during the recruitment period. All applications received after the first evaluation deadline will be considered during the second evaluation. Deadlines for each round of evaluation are as follows:
Applications received after December 2, 2019, will be considered only if space and scheduling constraints permit.
The United States Department of Commerce, International Trade Administration, U.S. and Foreign Commercial Service (USFCS) is organizing a trade mission to Hong Kong and the Indo Pacific region, that will include the Trade Winds Indo Pacific business forum in Hong Kong, April 20-28, 2020. U.S. trade mission members will participate in the Trade Winds—Indo Pacific business forum in Hong Kong (which is also open to U.S. companies not participating in the trade mission). Trade mission participants may participate in their choice of mission stops based on recommendations from the USFCS. Each trade mission stop will include one-on-one business appointments with pre-screened potential buyers, agents, distributors and joint-venture partners, and networking events. Trade mission participants electing to participate in the Trade Winds Indo Pacific business forum may attend regional consultations with USFCS Senior Commercial Officers and Officers from participating State Department Partner Posts.
This mission is open to U.S. companies from a cross section of industries with growth potential in Hong Kong and the Indo Pacific region, including but not limited to: Aerospace and defense, consumer goods, energy, franchising, healthcare, environmental technologies, information & communication technologies, design & construction, and environmental technologies.
This timetable allows for clients to take part in business matchmaking across the diverse Indo Pacific marketplace by offering scheduled business-to-business meetings in Hong Kong, South Korea, Japan, Thailand, and Vietnam. This structure ensures that each post has set days for meetings that allow the clients to explore up to three of their best prospects for business.
All parties interested in participating in the trade mission to Hong Kong (including mission stops with business matchmaking in Hong Kong and/or additional countries) must complete and submit an application package for consideration by the Department of Commerce. All applicants will be evaluated on their ability to meet certain conditions and best satisfy the selection criteria as outlined below.
A minimum of 40 companies and/or trade associations will be selected to participate in the mission from the applicant pool on a rolling basis. Mission stop participation will be limited as follows:
Additional companies may be accepted based on available space. U.S. companies and/or trade associations already doing business in or seeking business in Hong Kong, South Korea, Japan, Thailand, or Vietnam for the first time may apply.
If and when an applicant is selected to participate on a particular mission, a payment to the Department of Commerce in the amount of the designated participation fee below is required. Upon notification of acceptance to participate, those selected have 5 business days to submit payment or the acceptance may be revoked.
The below trade mission fees include the $750 participation fee for the Trade Winds business forum to be held in Hong Kong on April 20-28, 2020.
1. For one mission stop, the participation fee will be $2,200 for a small or medium-sized enterprise (SME) and $4,200 for large firms.
2. For two mission stops, the participation fee will be $3,400 for a small or medium-sized enterprise (SME) and $5,400 for large firms.
3. For three mission stops, the participation fee will be $4,600 for a small or medium-sized enterprise (SME) and $6,600 for large firms.
4. For four mission stops, the participation fee will be $5,800 for a small or medium-sized enterprise (SME) and $7,800 for large firms.
An additional representative for both SMEs and large firms at the Forum will require an additional fee of $500.
Mission recruitment will be conducted in an open and public manner, including publication in the
Recruitment for the mission will begin immediately and conclude no later than March 6, 2020. The U.S. Department of Commerce will review applications and make selection decisions on a rolling basis beginning 14 DAYS AFTER PUBLICATION OF THE
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meetings.
The Mid-Atlantic Fishery Management Council (Council) will hold public meetings of the Council and its Committees.
The meetings will be held Monday, October 7, 2019, from 9 a.m. to 5 p.m.; Tuesday, October 8, 2019. from 9 a.m. to 5 p.m.; Wednesday, October 9, 2019, from 9 a.m. to 5 p.m.; and, Thursday, October 10, 2019, from 9 a.m. to 1 p.m. For agenda details, see
The meeting will be held at the Durham Convention Center, 301 W. Morgan St., Durham, NC 27701; telephone: (919) 956-9404.
Christopher M. Moore, Ph.D. Executive Director, Mid-Atlantic Fishery Management Council; telephone: (302) 526-5255. The Council's website,
The following items are on the agenda, though agenda items may be addressed out of order (changes will be noted on the Council's website when possible.)
Although non-emergency issues not contained in this agenda may come before this group for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), those issues may not be the subject of formal action during these meetings. Actions will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The North Pacific Fishery Management Council (Council) Legislative Committee will meet in October.
The meeting will be held on Wednesday, October 2, 2019, from 3 p.m. to 5 p.m.
The meeting will be held at the Land's End Resort, 4786 Homer Spit Rd, Homer, AK 99603.
David Witherell, Council staff; telephone: (907) 271-2809.
The agenda will include updates on legislation, including HR 1979 and HR 2236, and development of recommendations for the Council.
The Agenda is subject to change, and the latest version will be posted at
Public comment letters will be accepted and should be submitted either electronically at:
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Shannon Gleason at (907) 271-2809 at least 7 working days prior to the meeting date.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The Gulf of Mexico Fishery Management Council will hold a meeting of its Law Enforcement Technical Committee (LETC), in conjunction with the Gulf States Marine Fisheries Commission's Law Enforcement Committee (LEC).
The meeting will convene on Wednesday, October 16, 2019; starting 8:30 a.m. and will adjourn at 5 p.m.
The meeting will be held at the Golden Nugget Biloxi Hotel and Casino, 151 Beach Blvd., Biloxi, MS 39530; telephone (228) 535-5400.
Dr. Ava Lasseter, Anthropologist, Gulf of Mexico Fishery Management Council;
The items of discussion on the agenda are as follows:
The Agenda is subject to change, and the latest version along with other meeting materials will be posted on
The Law Enforcement Technical Committee consists of principal law enforcement officers in each of the Gulf States, as well as the NOAA Law Enforcement, U.S. Fish and Wildlife Service, the U.S. Coast Guard, and the NOAA General Counsel for Law Enforcement.
Although other non-emergency issues not on the agenda may come before this group for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act, those issues may not be the subject of formal action during this meeting. Actions will be restricted to those issues specifically identified in the agenda and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kathy Pereira at the Gulf Council Office (see
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The Gulf of Mexico Fishery Management Council will hold a two-day meeting, Release Mortality Science Workshop.
The meeting will convene at 8:30 a.m. on Monday, October 7 and conclude at 12 p.m., EDT on Tuesday, October 8, 2019. For agenda details, see
The meeting will be held at the Tradewinds Island Resort, located at 5600 Gulf Boulevard, St. Petersburg Beach, FL; telephone: (727) 363-2215.
Emily Muehlstein, Public Information Officer, Gulf of Mexico Fishery Management Council;
The following items are on the agenda, though agenda items may be addressed out of order (changes will be noted on the Council's website when possible.)
The meeting will begin with Welcome and Introductions of members; followed by a number of presentations on Magnitude of Discard Mortality of Reef Fish in the Gulf of Mexico; Eastern Gulf: A Synopsis of Research on Recreational Fishing Practices and Discard Mortality; Northern Gulf: A Synopsis of Research on Discard Mortality; Western Gulf: A Synopsis of Research on Recreational Fishing Practices and Discard Mortality; and, a presentation on West Coast Success story: Yelloweye Rockfish Barotrauma Mitigation and Incorporation into Management and Stock Assessment Process.
After lunch, we will hold a facilitated discussion on Barotrauma Mitigation by Fleet and Reef Fish Species; build a barotrauma risk matrix, discuss best practices and devices for each fleet, and the rationale and barriers for methods.
We will receive a presentation on Overview of stock assessment inputs affected by release and release mortality rates; followed by a facilitated discussion to define necessary stock assessment inputs; suggest barotrauma mitigation research that could benefit stock assessments using existing monitoring frameworks and through novel research efforts; and, prioritize data gaps by species, fleets, and region.
The meeting will be broadcast via webinar. You may register for the listen-in access by visiting
Although other non-emergency issues not on the agenda may come before the group for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), those issues may not be the subject of formal action during this meeting. Actions will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kathy Pereira at the Gulf Council Office (see
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public workshops; correction.
NMFS announces that the date for the Safe Handling, Release, and Identification workshop originally scheduled for September 4, 2019, in Warwick, RI, has been changed to September 23, 2019. The date is being changed because inclement weather resulting from Hurricane Dorian prevented the instructors from traveling safely to the original workshop. The workshop time and location remains unchanged: 9 a.m. to 5 p.m. in Warwick, RI. The remaining September 2019, workshop in Panama City, FL, also remains unchanged. Safe Handling, Release, and Identification workshop are mandatory for shark and swordfish limited-access permit holders who fish with longline or gillnet gear. Additional free workshops will be conducted during 2019.
The date for the Safe Handling, Release, and Identification workshop to be held in Warwick, RI, is changed to September 23, 2019. See
The address for the Safe Handling, Release, and Identification workshop to be held in Warwick, RI, remains at the Hilton Garden Inn, 1 Thurber Street, Warwick, RI 02886. See
Rick Pearson by phone: (727) 824-5399.
The workshop schedules, registration information, and a list of frequently asked questions regarding these workshops are posted on the internet at:
In the
“5. September 23, 2019, 9 a.m.-5 p.m., Hilton Garden Inn, 1 Thurber Street, Warwick, RI 02886.”
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The Gulf of Mexico Fishery Management Council will hold a one-day meeting of its Outreach & Education Technical Committee.
The meeting will convene on Wednesday, October 9, 2019, from 8:30 a.m. to 5 p.m., EDT. For agenda details, see
The meeting will be held at the Tradewinds Island Resort, located at 5600 Gulf Boulevard, St. Petersburg Beach, FL; telephone: (727) 363-2215.
Emily Muehlstein, Public Information Officer, Gulf of Mexico Fishery Management Council;
The following items are on the agenda, though agenda items may be addressed out of order (changes will be noted on the Council's website when possible.)
Introductions of members, election of new chair, adoption of agenda, and approval of minutes from the May 2018 meeting summary. The committee will hear presentations on “Recreational Angler Perceptions Regarding the Use of Descending Devices in Southeast Reef Fish Fisheries” and “Barotrauma Mitigation and the Power of Subjective Norms in Florida's Reef Fish Fisheries.” The committee will review and discuss Gulf-wide Outreach/Communications Strategies to Reduce Barotrauma in Recreational Fisheries; Highlight specific approaches for For-Hire and private fleets and identify specific influencers across the region (media, business, and community leaders). The Committee will review the Council's new “Fishing for Our Future” best practices website and hear a presentation on the Gulf Council's Communications Analytics. The committee will discuss any Other Business items.
The meeting will be broadcast via webinar. You may register for the listen-in access by visiting
The Agenda is subject to change, and the latest version along with other meeting materials will be posted on
Although other non-emergency issues not on the agenda may come before the group for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), those issues may not be the subject of formal action during this meeting. Actions will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kathy Pereira at the Gulf Council Office (see
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of permits and permit amendments.
Notice is hereby given that permits or permit amendments have been issued to the following entities under the Marine Mammal Protection Act (MMPA) and the Endangered Species Act (ESA), as applicable.
The permits and related documents are available for review upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone: (301) 427-8401; fax: (301) 713-0376.
Shasta McClenahan (Permit Nos. 20430-01, 21476, and 22750) and Courtney Smith (Permit No. 21321-01); at (301) 427-8401.
Notices were published in the
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
As required by the ESA, as applicable, issuance of these permit was based on a finding that such permits: (1) Were applied for in good faith; (2) will not
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The New England Fishery Management Council (Council) is scheduling a public meeting of its Scientific & Statistical Committee to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
This meeting will be held on Thursday, October 17, 2019, beginning at 10 a.m. and Friday, October 18, 2019, beginning at 9 a.m.
The meeting will be held at the Hilton Garden Inn, Boston Logan, 100 Boardman Street, Boston, MA 02128; phone: (617) 567-6789.
Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The Scientific and Statistical Committee will:
Review recent stock assessment information from the 2017 Groundfish Management Track Assessments, information provided by the Council's Groundfish Plan Development Team (PDT) and recommend the overfishing levels and acceptable biological catch for Georges Bank (GB) cod, Gulf of Maine (GOM) cod, GB haddock, GOM haddock, Cape Cod/GOM yellowtail flounder, Southern New England/Mid-Atlantic yellowtail flounder, GB winter flounder, American plaice, witch flounder, pollock, white hake, Atlantic halibut, Northern windowpane flounder, and Southern windowpane flounder for fishing years 2020-21. They will also review the information provided by the Council's Scallop PDT and recommend the overfishing levels (OFLs) and acceptable biological catches (ABCs) for Atlantic sea scallops for fishing years 2020-21 (default). Other business will be discussed as needed.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during these meetings. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency. The public also should be aware that the meeting will be recorded, consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The Gulf of Mexico Fishery Management Council will hold a one-day meeting of its Reef Fish Advisory Panel (AP).
The meeting will convene on Wednesday, October 2, 2019, 8:30 a.m. to 5:30 p.m., EDT. For agenda details, see
The meeting will be held at the Gulf Council office.
Ryan Rindone, Fishery Biologist, Gulf of Mexico Fishery Management Council;
The following items are on the agenda, though agenda items may be addressed out of order (changes will be noted on the Council's website when possible.)
Introduction of members, adoption of agenda, and approval of minutes from the May 9, 2019 meeting (webinar). Staff will review the Scope of Work; and, hold an election for the Chair and Vice Chair seats. The AP will receive presentations on SEDAR 61: Gulf of Mexico Red Grouper Stock Assessment and an update on SEDAR 49: Gulf of Mexico Lane Snapper Itarget Assessment, along with the SSC Recommendations for Overfishing Limits (OFL) and Acceptable Biological Catch (ABC) for both; and, review the SEDAR 61 Executive Summary. The AP will receive updates on Florida Keys National Marine Sanctuary Expansion: Sanctuary Plan and Comments; Flower Garden Banks National Marine Sanctuary Expansion; and, the progress for Coral Amendment 9.
The AP will review draft Framework Action to Modify Greater Amberjack
The Chair will discuss any other business items.
The meeting will be broadcast via webinar. You may register for the listen-in access by visiting
The Agenda is subject to change, and the latest version along with other meeting materials will be posted on
Although other non-emergency issues not on the agenda may come before the group for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), those issues may not be the subject of formal action during this meeting. Actions will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kathy Pereira at the Gulf Council Office (see
16 U.S.C. 1801
Office of the Under Secretary of Defense for Personnel and Readiness, DoD.
30-Day information collection notice.
The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by October 16, 2019.
Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at
Angela James, 571-372-7574, or
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
•
Requests for copies of the information collection proposal should be sent to Ms. James at
Office of the Under Secretary of Defense for Personnel and Readiness, DoD.
30-Day information collection notice.
The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by October 16, 2019.
Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at
Angela James, 571-372-7574, or
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
•
Requests for copies of the information collection proposal should be sent to Ms. James at
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.
Interested persons are invited to submit comments on or before October 16, 2019.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Beth Grebeldinger, 202-377-4018.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Office of Postsecondary Education, Department of Education.
Notice.
The Department of Education (Department) is issuing a notice announcing the availability of funds and the application deadline for new grants to institutions of higher education (IHEs) under the Emergency Assistance to Institutions of Higher Education (2019 EAI) Program, Catalog of Federal Domestic Assistance (CFDA) number 84.938T, under title VIII of the Additional Supplemental Appropriations for Disaster Relief Act of 2019 (hereafter referred to as the Disaster Supplemental), for education-related disaster recovery activities
The addresses pertinent to this program, including the addresses for obtaining and submitting an application, can be found under
Beatriz Ceja, U.S. Department of Education, 400 Maryland Avenue SW, Room 260-04, Washington, DC 20202. Telephone: (202) 453-6239. Email:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
The open licensing requirement in 2 CFR 3474.20 does not apply to this program.
The Department is not bound by any estimates in this notice.
1.
Receiving a grant for emergency assistance under the 2019 EAI Program does not affect the eligibility of the IHE to apply for funding under any other Department program.
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(a) Submit an application in electronic portable document format (PDF) or Microsoft Word format via email to
(b) Mail the original and two copies of your application by express mail service through the U.S. Postal Service or through a commercial carrier to the program contact person listed under
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• A “page” is 8.5″ × 11″, on one side only, with 1” margins at the top, bottom, and both sides.
• Double space (no more than three lines per vertical inch) all text in the application narrative. Titles, headings, footnotes, quotations, references, and captions, as well as all text in charts, tables, figures, and graphs, are excluded.
• Use a font that is either 12 point or larger, and no smaller than 10 pitch (characters per inch).
• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial.
The recommended page limit does not apply to Part I, the cover sheet; Part II, the budget section, including the narrative budget justification; Part IV, the assurances and certifications. The page limit is recommended and non-binding.
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Allowable uses of funds include those authorized under the HEA. However, all activities funded under the program must be in the context of emergency assistance. That is, the funding must be used for activities directly related to mitigating the effects of a covered disaster or emergency on students and institutions. For instance, program funds may be used for student financial assistance, faculty and staff salaries, equipment, and student supplies and instruments. Grantees may not use program funds to supplant funds that otherwise would have been used for the same purpose, such as funds made available through an insurance policy, the Federal Emergency Management Agency (FEMA), a State, or a nonprofit relief organization, or any other third party. Grantees may use program funds to supplement funds from such sources up to the full amount needed for emergency assistance.
Use of funds for a purpose authorized under the HEA is subject to the regulations that pertain to that purpose. For example, if activities under a particular grant program or financial aid program were disrupted and require emergency aid to become fully operational, program funds for this purpose are subject to the regulations for that grant or aid program, except that any requirements relating to matching, Federal share, reservation of funds, or maintenance of effort under 20 U.S.C. 1087-51
Information about the Federal Student Aid programs is available at
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(a)
For direct student services applicants may only include those expenses directed to students who are homeless or at risk of becoming homeless, and applicants may not include expenses directed to a larger population of students, even if those expenses have aided some students who were homeless or at risk of becoming homeless. Applicants may, however, include expenses directed toward individual students who are homeless or at risk of becoming homeless, even if similar aid or services have been made available to other students.
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(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c).
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You may also access documents of the Department published in the
On March 6, 2019, Lock
The proposed project would consist of the following: (1) A new 30-foot-long, 30-foot-wide, 160-foot-high Large Frame Module; (2) two turbine-generator units with a total rated capacity of 1.5 megawatts; (3) a new 4-foot-long, 4-foot-wide, 3-foot-high pad-mounted transformer; (4) a new 300-foot-long, 13-kilovolt transmission line connecting the new transformer to an existing distribution line; and (5) appurtenant facilities. The proposed project would have an annual generation of 6,800 megawatt-hours.
The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of the Commission's website at
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j. Verdant requests a waiver of the Commission's pre-filing regulations under section 16.8(c) with respect to the requirement to submit a draft license application for the Roosevelt Island Tidal Energy Project. Verdant states that the project has a long history of consultation and that it proposes no substantive changes to the currently licensed pilot project. Further, Verdant indicates that it held two joint agency meetings (on January 8, 2019 and May 16, 2019), the second of which was held for federal agencies that were unable to attend the January meeting due to the funding lapse at certain federal agencies between December 22, 2018, and January 25, 2019. Verdant explains that the second joint agency meeting and the additional time needed to respond to study requests has reduced the amount of time available for submitting and effectively reviewing responses to a draft license application, prior to the filing of the final license application by December 31, 2019. Therefore, Commission staff is soliciting comments on Verdant's request to waive the requirement to file a draft license application for the Roosevelt Island Tidal Energy Project, pursuant to sections 16.8(c)(4) and 16.8(c)(6) of the Commission's regulations.
k. The deadline for filing comments is 15 days from the issuance date of this notice.
The Commission strongly encourages electronic filing. Please file motions to intervene and protests, comments, and final terms and conditions, recommendations, and prescriptions using the Commission's eFiling system at
l. A copy of the request is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website at
You may also register online at
On March 6, 2019, Lock
The proposed project would consist of the following: (1) A new 30-foot-long, 30-foot-wide, 160-foot-high Large Frame Module; (2) two turbine-generator units with a total rated capacity of 0.85 megawatt; (3) a new 4-foot-long, 4-foot-wide, 3-foot-high pad-mounted transformer; (4) a new 200-foot-long, 13-kilovolt transmission line connecting the new transformer to an existing distribution line; and (5) appurtenant facilities. The proposed project would have an annual generation of 3,700 megawatt-hours.
The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of the Commission's website at
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e. A summary of the meeting will be prepared and filed in the Commission's public file for the project.
f. All local, state, and federal agencies, Indian tribes, and other interested parties are invited to participate in-person or by telephone. However, as in-person seating is limited, priority will be given to parties directly involved in the ESA consultation process. Please contact Andy Bernick at
Take notice that on August 30, 2019, Tennessee Gas Pipeline Company, LLC (Tennessee), 1001 Louisiana Street, Houston, Texas 77002, filed in the above referenced docket a prior notice request pursuant to sections 157.203, 157.205, and 157.216(b) of the Commission's regulations under the Natural Gas Act and its blanket certificate issued in Docket No. CP82-413-000 for authorization to abandon an inactive injection/withdrawal well, designated as Well 5564, in the Hebron Storage Field (Field) located in Potter County, Pennsylvania. Specifically, Tennessee proposes to plug and abandon the well, abandon in place approximately 1,167 feet of six-inch related lateral pipeline, abandon by removal other related appurtenant facilities including the well head, and restore the well site. Tennessee states that the proposed abandonment of Well 5564 will not affect the capacity of the Field or the deliverability into or from the Field. Further, Tennessee states that the project will not abandon or decrease service to its customers. Tennessee estimates the cost of the project to be $550,000, all as more fully set forth in the application which is on file with the Commission and open to public inspection.
The filing may also be viewed on the web at
Any questions concerning this application may be directed to Ben J. Carranza, Director, Regulatory, Tennessee Gas Pipeline Company, LLC, 1001 Louisiana Street, Houston, Texas 77002, by telephone at (713) 420-5535, or by email at
Any person or the Commission's staff may, within 60 days after issuance of the instant notice by the Commission, file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention and pursuant to section 157.205 of the regulations under the NGA (18 CFR 157.205), a protest to the request. If no protest is filed within the time allowed therefore, the proposed activity shall be deemed to be authorized effective the day after the time allowed for filing a protest. If a protest is filed and not withdrawn within 30 days after the allowed time for filing a protest, the instant request shall be treated as an application for authorization pursuant to section 7 of the NGA.
Pursuant to section 157.9 of the Commission's rules (18 CFR 157.9), within 90 days of this Notice, the Commission staff will either: complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's EA.
Persons who wish to comment only on the environmental review of this project should submit an original and
The Commission strongly encourages electronic filings of comments, protests, and interventions in lieu of paper using the eFiling link at
On March 6, 2019, Lock
The proposed project would consist of the following: (1) A new 30-foot-long, 30-foot-wide, 160-foot-high Large Frame Module; (2) two turbine-generator units with a total rated capacity of 0.8 megawatt; (3) a new 4-foot-long, 4-foot-wide, 3-foot-high pad-mounted transformer; (4) a new 300-foot-long, 13-kilovolt transmission line connecting the new transformer to an existing distribution line; and (5) appurtenant facilities. The proposed project would have an annual generation of 3,500 megawatt-hours.
The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of the Commission's website at
Take notice that the Federal Energy Regulatory Commission (Commission) will convene a staff-led workshop in the above-referenced proceeding on Tuesday and Wednesday, November 5-6, 2019 from approximately 8:45 a.m. to 5:00 p.m. Eastern time. The conference will be held at Commission headquarters, 888 First Street NE, Washington, DC 20426. Commissioners may attend and participate.
The purpose of this workshop is to discuss grid-enhancing technologies that increase the capacity, efficiency, or reliability of transmission facilities. Panelists and staff will discuss how grid-enhancing technologies are currently used in transmission planning and operations, the challenges to their deployment and implementation, and what the Commission can do regarding those challenges, including incentivizing or requiring the adoption of grid-enhancing technologies by utilities and RTOs/ISOs. These technologies include, but are not limited to: (1) Power flow control and transmission switching equipment; (2) storage technologies, and (3) advanced line rating management technologies. Participants at this workshop will include representatives from utilities, RTOs/ISOs, technology vendors, researchers, and other interested parties. Further details and a formal agenda will be issued prior to the conference.
The workshop will be open for the public to attend. Advance registration is not required to attend, but is encouraged. Attendees may register at the following web page:
Those wishing to participate as a panel member in this conference should submit a nomination form online by 5:00 p.m. on September 20, 2019 at:
The workshop will be transcribed and webcast. Transcripts will be available for a fee from Ace Reporting (202-347-3700). A link to the webcast of this event will be available in the Commission Calendar of Events at
Commission conferences are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations, please send an email to
For more information about this workshop, please contact Samin Peirovi at
Environmental Protection Agency (EPA).
Notice of availability; request for comments.
The Environmental Protection Agency (EPA) is requesting public comment to inform the development of an Agency policy for determining if a harmful algal bloom (HAB) or hypoxia event in freshwater is an “event of national significance.” Recent amendments to the Harmful Algal Bloom and Hypoxia Research and Control Act (HABHRCA), provide the EPA with the statutory authority to make such a determination in the case of a freshwater HAB or hypoxia event. Public comments are intended to inform the development of a policy for the EPA to make such determinations, specifically for events in freshwater. A federal determination that such an occurrence is an event of national significance enables mobilization of federal resources to assess and mitigate its detrimental effects, subject to the availability of appropriations. The EPA requests input on what the Agency should specifically consider for determining a “HAB or Hypoxia event of national significance” in freshwater, and related factors in order to inform development of a draft EPA policy. On July 25, 2019, the National Oceanic and Atmospheric Administration (NOAA) issued a separate notice to solicit comments on HAB or hypoxia events of national significance in marine and coastal waters.
Comments must be received on or before October 31, 2019.
Submit your comments, identified by Docket ID No. EPA-HQ-OW-0463 to the
Dr. Lesley V. D'Anglada, Health and Ecological Criteria Division, Office of Water (Mail Code 4304T), Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone number: (202) 566-1125; email address:
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Harmful algal blooms (HABs) are caused by certain types of photosynthetic organisms that under certain conditions form large accumulations of algae that can adversely affect human health and the environment and can cause local economic losses. In freshwater, cyanobacteria are the major HABs-forming taxon. Cyanobacteria are microorganisms that can produce harmful
Hypoxia is a condition where the concentration of dissolved oxygen (DO) in a portion of the water column decreases to a level that can no longer support aquatic life, typically less than 2-3 milligrams DO per liter. A variety of factors cause low or zero oxygen conditions in waterbodies, including nitrogen and phosphorus pollution, and waterbody stratification, or layering, due to temperature gradients. Low dissolved oxygen conditions are a serious environmental concern that can impact valuable fisheries and disrupt sensitive ecosystems. In freshwater lakes, hypoxia in deeper waters coupled with warm shallow waters can severely limit the habitat available for fish species, such as trout. Exposure to hypoxia can cause adverse effects to aquatic life, such as reduced growth and reproduction. For more details on HABs, please refer to this site:
In 1998, Congress recognized the severity of these threats and passed the Harmful Algal Bloom and Hypoxia Research and Control Act (HABHRCA 1998, Pub. L. 105-383). The Harmful Algal Bloom and Hypoxia Research and Control Amendments Act of 2004 (HABHRCA 2004, Pub. L. 108-456) and 2014 (HABHRCA 2014, Pub. L. 113-124) reaffirmed and expanded the mandate for NOAA to advance the scientific understanding and ability to detect, monitor, assess, and predict HAB and hypoxia events. Congress most recently reauthorized and amended HABHRCA through the National Integrated Drought Information System Reauthorization Act of 2018 (Pub. L. 115-423, § 9). This most recent reauthorization and amendment of HABHRCA is referred to as the Harmful Algal Bloom and Hypoxia Research and Control Amendments Act of 2017 (HABHRCA 2017). HABHRCA 2017 provides NOAA and EPA with authority to make a determination of a “HAB or hypoxia event of national significance,” for marine or coastal events or freshwater events, respectively, either in the discretion of the Agency head or at the request of a Governor of an affected state (33 U.S.C. 4010). Following such a determination, federal officials may “make sums available to the affected State or local government for the purposes of assessing and mitigating the detrimental environmental, economic, subsistence use, and public health effects of the event of national significance.” Funds would be subject to the availability of appropriations, though either of the respective agencies may accept donations of funds, services, facilities, materials, or equipment determined necessary for the purpose of assessing and mitigating the detrimental effects, and donated funds may be expended without further appropriation and without fiscal year limitation. As directed under HABHRCA 2017, EPA, in coordination with NOAA, intends to develop a policy for determining a HAB or Hypoxia occurrence as an “event of national significance” in freshwater systems in the United States. NOAA issued a separate notice to solicit comments on marine and coastal hypoxia or HAB events in 84 FR 35854 on July 25, 2019. After consideration of comments on this notice, the EPA anticipates developing a draft policy for which the Agency would solicit further comment.
HABHRCA 2017 identified the following six factors to be considered in making the determination of a “HAB or hypoxia event of national significance:” the toxicity of the harmful algal bloom; the severity of the hypoxia; its potential to spread; the economic impact; the relative size in relation to the past five occurrences of harmful algal blooms or hypoxia events that occur on a recurrent or annual basis; and the geographic scope, including the potential to affect several municipalities, to affect more than one state, or to cross an international boundary.
The EPA is soliciting public comments regarding the factors provided by the amendments for the EPA to determine a HAB or Hypoxia Event of National Significance in freshwater systems. The EPA requests separate comment on the application of those factors for HAB and hypoxia events as it is likely that the factors would be considered differently for the different types of events. Specifically, the EPA is soliciting public comments on how to define, quantify, and weigh the following statutory parameters:
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The EPA is also requesting comments on whether the Agency should consider developing additional criteria and
A. Should the EPA consider the state's access to critical resources (human, financial, and infrastructure) in determining national significance? For example, does the state have access to technical expertise, necessary supplies/equipment, and alternate sources of water? If the EPA considers such access, what metrics should the EPA use to measure the capacity of state and local or tribal governments to address the bloom event?
B. Should the EPA consider certain factors when an event impacts or threatens drinking water sources or finished drinking water? How should duration, magnitude, frequency, extent, and toxicity of HAB impacts on drinking water supplies be considered in determining events of national significance?
C. Should the EPA consider certain factors when an event has impacts on or threatens recreational waters? How should these impacts be weighed in determining national significance?
D. Should a determination of national significance be made only if funding has been appropriated to the agencies? If two or more states request determinations, and the determinations of national significance would otherwise qualify each state for funding consistent with the factors considered in making the determination, but only limited funds are available, how should amounts be distributed? Should the funding be equally proportioned or distributed according to some sort of a relative rank or score derived from a weighting of factors considered in the determination of national significance?
E. What information should an impacted state provide to the EPA when requesting a determination of a freshwater event of national significance or a request to make sums available to the impacted state or local government to assess and mitigate an event of national significance?
F. Should the EPA consider whether a state or local government that requests a determination that a HAB or hypoxia is an event of national significance concurrently requests other Federal relief for the same event or occurrence? If so, how should the EPA prioritize funding, for example, based on consideration of a particular factor or multiple factors?
G. Should the EPA require that an affected state or local government request a determination of a freshwater event of national significance within certain timeframes with respect to the start or end of the event or occurrence?
H. Other than funds, what tools and methods should the EPA make available after a determination of a freshwater event of national significance is made?
Environmental Protection Agency (EPA).
Notice of Public Federal Advisory Committee Teleconference.
Pursuant to the Federal Advisory Committee Act, Public Law 92-463, notice is hereby given that the Good Neighbor Environmental Board (Board) will hold a public teleconference on September 19, 2019 from 12:00 p.m.-4:00 p.m. Eastern Daylight Time. Due to unforeseen administrative circumstances, EPA is announcing this teleconference with less than 15 calendar days' notice. For further information regarding the teleconference and background materials, please contact Ann-Marie Gantner at the number and email provided below.
Environmental Protection Agency (EPA).
Notice of availability; request for comments.
The Environmental Protection Agency (EPA) is requesting public comment on a draft
To accelerate the consideration of water reuse approaches and build on existing science, research, policy, technology, and both national and international experiences, the EPA has facilitated development of this draft
This action is part of a larger effort by the Administration to better coordinate and focus taxpayer resources on some of
Comments must be received on or before December 16, 2019.
Submit your comments, identified by Docket ID No. EPA-HQ-OW-0174 to the
John Ravenscroft, Office of Science and Technology, Office of Water (Mail Code 3207A), Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone number: (202) 566-1101; email address:
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Clean, safe, and reliable water supplies for human consumption, agriculture, business, recreation, and healthy ecosystems are critical to our Nation's communities and economy. Due to various pressures, it is reported that 40 states anticipate some freshwater shortages in the next decade. Communities, agriculture, and businesses are looking to diversify their water supply portfolios to meet current and future needs. Water reuse (also known as recycled or reclaimed water) represents a major opportunity to supplement existing water supplies from potential sources for reuse from industrial process water, agricultural return flows, municipal wastewater, oil and gas produced water, and stormwater, when these potential sources are appropriately and effectively treated to meet “fit for purpose specifications” including appropriate public health and environmental needs.
The goal of the draft Action Plan is to better coordinate and focus taxpayer resources on some of the Nation's most challenging water resource concerns, including ensuring water availability and mitigating the risks posed by droughts. The draft Action Plan contains key actions identified by stakeholders across the water reuse sector that can help improve water security, sustainability, and resilience.
The draft
Section 2 of the draft Action Plan identifies 46 proposed actions across the following ten strategic objectives:
1. Enable consideration of water reuse with integrated and collaborative action at the watershed scale.
2. Coordinate and integrate federal, state, tribal, and local water reuse programs and policies.
3. Compile and refine fit-for-purpose specifications.
4. Promote technology development, deployment, and validation.
5. Improve availability of water information.
6. Facilitate financial support of water reuse.
7. Integrate and coordinate research on water reuse.
8. Improve outreach and communication on water reuse.
9. Support a talented and dynamic workforce.
10. Develop water reuse metrics that support goals and measure progress.
As explained in the methodology, these proposed actions were identified from the following sources:
1. Analysis and summary of the water reuse literature (greater than 150 sources).
2. Outreach and dialogue with an estimated 2,300 participants.
3. Public input submitted to the first public docket on the plan (opened from April 18, 2019 until July 1, 2019).
4. WateReuse Association expert convening report (conducted in Spring 2019).
5. Review of international experiences with water reuse.
6. Review of water reuse case studies from relevant applications throughout the United States.
Section 3 of the draft Action Plan describes the process for going forward to identify the highest priority actions and seeks leaders and collaborators to describe and commit to specific actions.
The draft plan and the associated appendices can be found at:
• Identify the most important actions they feel should be taken in the near term.
• Identify and describe the specific attributes and characteristics of the actions that will achieve success.
• Identify critical implementation steps and milestones necessary to successfully implement the proposed actions.
• Commit to lead or collaborate with others on implementing any of the proposed actions.
• Provide additional information or recommendations to inform these or other proposed actions.
The goal is to issue a final Action Plan that includes clear commitments and milestones for actions that will further water reuse to help ensure the sustainability, security, and resilience of the Nation's water resources.
Federal Deposit Insurance Corporation (FDIC).
Agency information collection activities: submission for OMB review; comment request.
The FDIC, as part of its obligations under the Paperwork Reduction Act of 1995, invites the general public and other Federal agencies to take this opportunity to comment on the renewal of the existing information collection described below (3064-0188) on July 16, 2019, the FDIC requested comment for 60 days on a proposal to renew the information collection described below. No comments were received. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the renewal of this collection, and again invites comment on this renewal.
Comments must be submitted on or before October 16, 2019.
Interested parties are invited to submit written comments to the FDIC by any of the following methods:
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All comments should refer to the relevant OMB control number. A copy of the comments may also be submitted to the OMB desk officer for the FDIC: Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503.
Manny Cabeza, Counsel, 202-898-3767,
On July 16, 2019, the FDIC requested comment for 60 days on a proposal to renew the information collection described below. No comments were received. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the renewal of this collection, and again invites comment on this renewal.
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Section 1471 of the Dodd-Frank Act established a new Truth in Lending (TILA) section 129H, which contains appraisal requirements applicable to higher-risk mortgages and prohibits a creditor from extending credit in the form of a higher-risk mortgage loan to any consumer without meeting those requirements. A higher-risk mortgage is defined as a residential mortgage loan secured by a principal dwelling with an annual percentage rate (APR) that exceeds the average prime offer rate (APOR) for a comparable transaction as of the date the interest rate is set by certain enumerated percentage point spreads. The rule requires that, within three days of application, a creditor provide a disclosure that informs consumers regarding the purpose of the appraisal, that the creditor will provide the consumer a copy of any appraisal, and that the consumer may choose to have a separate appraisal conducted at the expense of the consumer. If a loan meets the definition of a higher-risk mortgage loan, then the creditor would be required to obtain a written appraisal prepared by a certified or licensed appraiser who conducts a physical visit of the interior of the property that will secure the transaction, and send a copy of the written appraisal to the consumer. To qualify for the safe harbor provided under the rule, a creditor is required to review the written appraisal as specified in the text of the rule and appendix A. If a loan is classified as a higher-risk mortgage loan that will finance the acquisition of the property to be mortgaged, and the property was acquired within the previous 180 days by the seller at a price that was lower than the current sale price, then the creditor is required to obtain an additional appraisal. A creditor is required to provide the consumer a copy of the appraisal reports performed in connection with the loan, without charge, at least days prior to consummation of the loan.
There is no change in the method or substance of the collection. The overall reduction in burden hours is the result of economic fluctuation. In particular,
Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collection, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. All comments will become a matter of public record.
The Federal Deposit Insurance Corporation (FDIC or Receiver), as Receiver for each of the following insured depository institutions, was charged with the duty of winding up the affairs of the former institutions and liquidating all related assets. The Receiver has fulfilled its obligations and made all dividend distributions required by law.
The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary, including but not limited to releases, discharges, satisfactions, endorsements, assignments, and deeds. Effective on the termination dates listed above, the Receiverships have been terminated, the Receiver has been discharged, and the Receiverships have ceased to exist as legal entities.
12 U.S.C. 1819.
The liquidation of the assets for the receivership has been completed. To the extent permitted by available funds and in accordance with law, the Receiver will be making a final dividend payment to proven creditors.
Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing, identify the receivership to which the comment pertains, and sent within thirty days of the date of this notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 34.6, 1601 Bryan Street, Dallas, TX 75201.
No comments concerning the termination of this receivership will be considered which are not sent within this time frame.
12 U.S.C. 1819.
Notice is hereby given that the Federal Deposit Insurance Corporation (FDIC or Receiver) as Receiver for the institution listed below intends to
The liquidation of the assets for the receivership has been completed. To the extent permitted by available funds and in accordance with law, the Receiver will be making a final dividend payment to proven creditors.
Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing, identify the receivership to which the comment pertains, and sent within thirty days of the date of this notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 34.6, 1601 Bryan Street, Dallas, TX 75201.
No comments concerning the termination of this receivership will be considered which are not sent within this time frame.
12 U.S.C. 1819
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than October 7, 2019.
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Section 7A of the Clayton Act, 15 U.S.C. 18a, as added by Title II of the Hart-Scott-Rodino Antitrust Improvements Act of 1976, requires persons contemplating certain mergers or acquisitions to give the Federal Trade Commission and the Assistant Attorney General advance notice and to wait designated periods before consummation of such plans. Section 7A(b)(2) of the Act permits the agencies, in individual cases, to terminate this waiting period prior to its expiration and requires that notice of this action be published in the
The following transactions were granted early termination—on the dates indicated—of the waiting period provided by law and the premerger notification rules. The listing for each transaction includes the transaction number and the parties to the transaction. The grants were made by the Federal Trade Commission and the Assistant Attorney General for the Antitrust Division of the Department of Justice. Neither agency intends to take any action with respect to these proposed acquisitions during the applicable waiting period.
By direction of the Commission.
Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, and the Office of Management and Budget (OMB) regulations, DoD, GSA, and NASA invite the public to comment on a revision and renewal concerning commercial item. DoD, GSA, and NASA invite comments on: Whether the proposed collection of information is necessary for the proper performance of the functions of Federal Government acquisitions, including whether the information will have practical utility; the accuracy of the estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including the use of automated collection techniques or other forms of information technology. OMB has approved this information collection for use through November 30, 2019. DoD, GSA, and NASA propose that OMB extend its approval for use for three additional years beyond the current expiration date.
DoD, GSA, and NASA will consider all comments received by November 15, 2019.
DoD, GSA, and NASA invite interested persons to submit comments on this collection by either of the following methods:
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Mr. Michael O. Jackson, Procurement Analyst, at telephone 202-208-4949, or email at
9000-0136, Commercial Item Acquisitions.
The Federal Acquisition Streamlining Act of 1994 reformed Federal acquisition statutes to encourage and facilitate the acquisition of commercial items and services by the Federal Government. Accordingly, DoD, NASA, and GSA amended the Federal Acquisition Regulation (FAR) to include streamlined/simplified procedures for the acquisition of commercial items.
Pertinent to this information collection, FAR Provision 52.212-3, “Offeror Representations and Certifications—Commercial Items,” was implemented to combine the multitude of individual provisions used in Government solicitations into a single provision for use in commercial acquisitions. The provision is among the representations and certifications that are available for completion in the System for Award Management (SAM).
Women's Suffrage Centennial Commission, General Services Administration.
Meeting notice.
Meeting notice is being provided according to the requirements of the Federal Advisory Committee Act. This notice provides the schedule and agenda for the October 3, 2019, in-person meeting of the Women's Suffrage Centennial Commission (Commission). The meeting is open to the public.
The meeting will be held on Thursday, October 3, 2019, beginning at 9:00 a.m., EDT (Eastern Daylight Time), and ending no later than 4:00 p.m., EDT.
The meeting will be held at The Workhouse Arts Center, 9518 Workhouse Way, Lorton, VA 22079. The public may also dial into the meeting by calling 1-510-338-9438 Meeting number (access code): 795 610 599
Kim Oliver, Designated Federal Officer, Women's Suffrage Centennial Commission, 1849 C Street NW, Room 7313, Washington, DC 20240; phone: (202) 208-7301; fax: (202) 219-2100; email:
Congress passed legislation to create the Women's Suffrage Centennial Commission Act, a bill, “to ensure a suitable observance of the centennial of the passage and ratification of the 19th Amendment of the Constitution of the
The duties of the Commission, as written in the law, include: (1) To encourage, plan, develop, and execute programs, projects, and activities to commemorate the centennial of the passage and ratification of the 19th Amendment; (2) To encourage private organizations and State and local Governments to organize and participate in activities commemorating the centennial of the passage and ratification of the 19th Amendment; (3) To facilitate and coordinate activities throughout the United States relating to the centennial of the passage and ratification of the 19th Amendment; (4) To serve as a clearinghouse for the collection and dissemination of information about events and plans for the centennial of the passage and ratification of the 19th Amendment; and (5) To develop recommendations for Congress and the President for commemorating the centennial of the passage and ratification of the 19th Amendment.
• Call to Order, Opening Remarks, Roll Call
• Housekeeping Announcement
• Approval of Meeting Minutes
• Executive Director Update
• Communications Update
• Subcommittee Updates
• Lunch Break
• Public Comment
• Wrap Up/Next Steps
• Adjourn
Interested persons may choose to make a public comment at the meeting during the designated time for this purpose. Public comments shall be limited by minutes based on the number of participants signed up to comment for the allotted time, and subject to agenda time changes based on the speed of the commission's work through the agenda. Speakers who wish to expand upon their oral statements, or those who had wished to speak but could not be accommodated on the agenda, may submit written statements up to 30 days after the meeting.
Members of the public may also choose to submit written comments by mailing them to Kim Oliver, Designated Federal Officer, 1849 C Street NW, Room 7313, Washington, DC 20240, or via email at
Individuals requiring special accommodations to access the public meeting should contact Ms. Oliver at least five business days prior to each meeting, so that appropriate arrangements can be made.
Before including your address, phone number, email address, or other personally identifiable information (PII) in your comment, you should be aware that your entire comment—including your PII—may be made publicly available at any time.
While you can ask us in your comment to withhold your PII from public review, we cannot guarantee that we will be able to do so.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice.
The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) is publishing the names of the Performance Review Board Members who are reviewing performance of Senior Executive Service (SES) members, Title 42 (T42) executives, and Senior Level (SL) employees for Fiscal Year 2019.
Sandra De Shields, Team Chief, Executive and Scientific Resources Office, Human Resources Office, Centers for Disease Control and Prevention, 11 Corporate Square Blvd., Mailstop US11-2, Atlanta, Georgia 30341, Telephone (770) 488-0252.
Title 5, U.S.C. Section 4314(c) (4) of the Civil Service Reform Act of 1978, Public Law 95-454, requires that the appointment of Performance Review Board Members be published in the
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice.
This notice announces a 1-year extension of the Medicare Prior Authorization Model for Repetitive Scheduled Non-Emergent Ambulance Transport. The extension of this model is applicable to the following states and the District of Columbia: Delaware, Maryland, New Jersey, North Carolina, Pennsylvania, South Carolina, Virginia, and West Virginia.
This extension begins on December 2, 2019 and ends on December 1, 2020.
Angela Gaston, (410) 786-7409.
Questions regarding the Medicare Prior Authorization Model Extension for Repetitive Scheduled Non-Emergent Ambulance Transport should be sent to
Medicare may cover ambulance services, including air ambulance (fixed-wing and rotary-wing) services,
Non-emergent transportation by ambulance is appropriate if either the—(1) beneficiary is bed-confined and it is documented that the beneficiary's condition is such that other methods of transportation are contraindicated; or (2) beneficiary's medical condition, regardless of bed confinement, is such that transportation by ambulance is medically required. Thus, bed confinement is not the sole criterion in determining the medical necessity of non-emergent ambulance transportation; rather, it is one factor that is considered in medical necessity determinations.
A repetitive ambulance service is defined as medically necessary ambulance transportation that is furnished in 3 or more round trips during a 10-day period, or at least 1 round trip per week for at least 3 weeks.
Medicare may cover repetitive, scheduled non-emergent transportation by ambulance if the—(1) medical necessity requirements described previously are met; and (2) ambulance provider/supplier, before furnishing the service to the beneficiary, obtains a written order from the beneficiary's attending physician certifying that the medical necessity requirements are met (see 42 CFR 410.40(d)(1) and (2)).
In addition to the medical necessity requirements, the service must meet all other Medicare coverage and payment requirements, including requirements relating to the origin and destination of the transportation, vehicle and staff, and billing and reporting. Additional information about Medicare coverage of ambulance services can be found in 42 CFR 410.40, 410.41, and in the Medicare Benefit Policy Manual (Pub. 100-02), Chapter 10, at
According to a study published by the Government Accountability Office in October 2012, entitled “Costs and Medicare Margins Varied Widely; Transports of Beneficiaries Have Increased,”
Section 1115A of the Social Security Act (the Act) authorizes the Secretary to test innovative payment and service delivery models expected to reduce program expenditures, while preserving or enhancing the quality of care furnished to Medicare, Medicaid, and Children's Health Insurance Program beneficiaries.
In the November 14, 2014
In the October 23, 2015
In the December 12, 2017
In the December 4, 2018
This notice announces that the testing of the model under section 1115A of the Act is again being extended in the current model states of Delaware, the District of Columbia, Maryland, New Jersey, North Carolina, Pennsylvania, South Carolina, Virginia, and West Virginia for an additional year while we continue to work towards nationwide expansion under section 1834(l)(16) of the Act. The existing testing of the model under section 1115A authority is currently scheduled to end in all states on December 1, 2019; however, this notice extends the model under the authority in section 1115A of the Act through December 1, 2020.
Under this extension of the model under section 1115A authority, we will continue to test whether prior authorization helps reduce expenditures, while maintaining or improving quality of care, using the prior authorization process as described in 83 FR 62577. Section 1115A(d)(1) of
We will continue to use this prior authorization process to help ensure that all relevant clinical or medical documentation requirements are met before services are furnished to beneficiaries and before claims are submitted for payment. The prior authorization process further helps to ensure that payment complies with Medicare documentation, coverage, payment, and coding rules.
The use of prior authorization does not create new clinical documentation requirements. Instead, it requires the same information that is already required to support Medicare payment, just earlier in the process. Prior authorization allows ambulance suppliers to address coverage issues prior to furnishing services.
The prior authorization process under the extension of the model under 1115A authority will continue to apply in the nine states listed previously for the following codes for Medicare payment:
• A0426 Ambulance service, advanced life support, non-emergency transport, Level 1 (ALS1).
• A0428 Ambulance service, BLS, non-emergency transport.
Under the model extension under section 1115A authority, we will continue our outreach and education efforts to ambulance suppliers, as well as beneficiaries, through such methods as updating the operational guide, frequently asked questions (FAQs) on our website, a physician letter explaining the ambulance suppliers' need for the proper documentation, and educational events and materials issued by the Medicare Administrative Contractors (MACs).
We will continue to work to limit any adverse impact on beneficiaries and to educate beneficiaries about the model process. If a prior authorization request is non-affirmed, and the claim is still submitted by the ambulance supplier, the claim will be denied, but beneficiaries will continue to have all applicable administrative appeal rights. We will also continue our initiative to help find alternative resources for beneficiaries who do not meet the requirements of the Medicare repetitive scheduled non-emergent ambulance transport benefit.
Additional information is available on the CMS website at
Section 1115A(d)(3) of the Act states that chapter 35 of title 44, United States Code (the Paperwork Reduction Act of 1995), shall not apply to the testing and evaluation of models or expansion of such models under this section. Consequently, this document need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995.
This document announces a 1-year extension of the Medicare Prior Authorization Model for Repetitive Scheduled Non-Emergent Ambulance Transport. Therefore, there are no regulatory impact implications associated with this notice.
Section 1115A of the Social Security Act.
Centers for Medicare & Medicaid Services, HHS.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the
Comments on the collection(s) of information must be received by the OMB desk officer by October 16, 2019.
When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' website address at website address at
1. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
2. Call the Reports Clearance Office at (410) 786-1326.
William Parham at (410) 786-4669.
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of
1.
The States must conduct RetroDUR which provides for the ongoing periodic examination of claims data and other records in order to identify patterns of fraud, abuse, inappropriate or medically unnecessary care. Patterns or trends of drug therapy problems are identified and reviewed to determine the need for intervention activity with pharmacists and/or physicians. States may conduct interventions via telephone, correspondence, or face-to-face contact.
Annual reports are submitted to CMS for the purposes of monitoring compliance and evaluating the progress of States' DUR programs. The information submitted by States is reviewed and results are compiled by CMS in a format intended to provide information, comparisons, and trends related to States' experiences with DUR. States benefit from the information and may enhance their programs each year based on State reported innovative practices that are compiled by CMS from the DUR annual reports.
Food and Drug Administration, HHS.
Notice; correction.
The Food and Drug Administration (FDA) is correcting a notice that appeared in the
Jennifer Forde, Office of Regulatory Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6228, Silver Spring, MD 20993, 301-348-3035.
In the
1. On page 1746, in the table, the entry for ANDA 077895 is removed.
In a separate notice published in this issue of the
Food and Drug Administration, HHS.
Notice; request for comments.
The Food and Drug Administration (FDA or Agency) is announcing that it has received a petition requesting exemption from the premarket notification requirements for powered wheeled stretchers. These devices are battery-powered tables with wheels that are intended for medical purposes for use by patients who are unable to propel themselves independently and who must maintain a prone or supine position for prolonged periods because of skin ulcers or contractures (muscle contractions). FDA is publishing this notice to obtain comments in accordance with procedures established by the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Submit either electronic or written comments by November 15, 2019.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 15, 2019. The
Submit electronic comments in the following way:
•
• 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”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, 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.”
• 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
Bryan Benesch, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1538, Silver Spring, MD 20993-0002, 301-796-5506.
FDA classifies devices into one of three regulatory classes: class I, class II, or class III, based on the amount of regulation necessary to provide a reasonable assurance of safety and effectiveness (see section 513 of the FD&C Act (21 U.S.C. 360c)). Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and the implementing regulations, 21 CFR part 807 subpart E, require persons who intend to market a new device to submit and obtain clearance of a premarket notification (510(k)) containing information that allows FDA to determine whether the new device is “substantially equivalent” within the meaning of section 513(i) of the FD&C Act to a legally marketed device that does not require premarket approval.
The 21st Century Cures Act (Pub. L. 114-255) (Cures Act) was signed into law on December 13, 2016. Section 3054 of the Cures Act amended section 510(m) of the FD&C Act. As amended, section 510(m)(2) of the FD&C Act provides that, 1 calendar day after the date of publication of the final list under paragraph (1)(B), FDA may exempt a class II device from the requirement to submit a report under section 510(k) of the FD&C Act upon its own initiative or a petition of an interested person, if FDA determines that a report under section 510(k) is not necessary to assure the safety and effectiveness of the device. To do so, FDA must publish in the
There are a number of factors FDA may consider to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the guidance the Agency issued on February 19, 1998, entitled ”Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff.” (Class II 510(k) Exemption Guidance) (available at
FDA has received the following petition requesting an exemption from premarket notification for a class II device: Stryker, 3800 East Centre Ave., Portage, MI 49002, for powered wheeled stretcher, classified under 21 CFR 890.3690. With this notice FDA is seeking comments on the petition in accordance with section 510(m)(2) of the FD&C Act.
This notice refers to previously approved collections of information found in FDA regulations. These collections of information 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 21 CFR 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is withdrawing the approval of abbreviated new drug application (ANDA) 077895 for Ursodiol Capsules USP, 300 milligrams (mg), held by Impax Laboratories, LLC (Impax). Impax requested withdrawal of this application and has waived its opportunity for a hearing.
Approval is withdrawn as of September 16, 2019.
Jennifer Forde, Office of Regulatory Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6228, Silver Spring, MD 20993-0002, 301-348-3035.
On July 27, 2006, FDA approved ANDA 077895 for Ursodiol Capsules USP, 300 mg, submitted by CorePharma, LLC (CorePharma). According to annual reports filed with the Agency, this product has not been commercially manufactured since February 2010.
In a letter dated August 9, 2011, FDA informed CorePharma that it had concerns about the validity of bioequivalence data submitted with ANDA 077895 from studies conducted by a certain contract research organization intended to establish bioequivalence of CorePharma's product to its reference listed drug (RLD), new drug application 019594, Actigall (Ursodiol) Capsules, 300 mg. In that letter, FDA directed CorePharma to supplement its ANDA with either: (1) New bioequivalence studies or (2) re-assays of the samples from the original bioequivalence studies. In a letter dated January 26, 2012, CorePharma submitted a request for an extension of time to submit new bioequivalence data in response to the Agency's August 9, 2011, letter. On February 10, 2012, the Agency granted CorePharma's request for an extension to submit new bioequivalence data by October 30, 2012.
FDA subsequently sent another letter to CorePharma on August 19, 2016, requesting that CorePharma provide the requested bioequivalence data within 30 calendar days or voluntarily seek withdrawal of ANDA 077895 under § 314.150(d) (21 CFR 314.150(d)). In response to the August 19, 2016, correspondence, FDA received a letter from CorePharma dated September 7, 2016, stating that CorePharma did not wish to request the withdrawal of approval of ANDA 077895 for Ursodiol Capsules. In February 2017, the Agency was notified that the ownership of ANDA 077895 was transferred from CorePharma to Impax.
On April 24, 2017, FDA issued a letter to Impax, noting that as of the date of the April 24, 2017, letter, FDA had not received the requested bioequivalence data. In the April 24, 2017, correspondence, FDA strongly suggested to Impax that it voluntarily seek withdrawal of ANDA 077895 under § 314.150(d) as a result of failing to provide data and information establishing bioequivalence to the RLD. In a letter dated February 25, 2019, Impax informed FDA that it would like to request the withdrawal of ANDA 077895 under § 314.150(d). Additionally, in a March 14, 2019, correspondence to FDA, Impax waived any opportunity for hearing provided under § 314.150(a).
In the
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Siemens Healthcare Diagnostics, Inc. (Siemens), for the ADVIA Centaur Zika test. FDA revoked this Authorization on July 17, 2019, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), in consideration of the premarket notification submission submitted to FDA by Siemens for the ADVIA Centaur Zika test that was determined to be substantially equivalent to a legally marketed class II predicate device on July 17, 2019. The revocation, which includes an explanation of the reasons for revocation, is reprinted in this document.
The Authorization is revoked as of July 17, 2019.
Submit written requests for single copies of the revocation to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the revocation may be sent. See the
Jennifer J. Ross, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-0002, 240-402-8155 (this is not a toll-free number).
Section 564 of the FD&C Act (21 U.S.C. 360bbb-3), as amended by the Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. On September 18, 2017, FDA issued an EUA to Siemens, for the ADVIA Centaur Zika test, subject to the terms of the Authorization. Notice of the issuance of the Authorization was published in the
On July 17, 2019, FDA revoked the EUA for Siemens' ADVIA Centaur Zika test because the criteria for issuance were no longer met. Under section 564(c)(3) of the FD&C Act, an EUA may be issued only if FDA concludes there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the disease or condition. FDA has determined that the criteria for issuance of such authorization under section 564(c)(3) of the FD&C Act are no longer met because Siemens' ADVIA Centaur Zika test was determined on July 17, 2019, to be substantially equivalent to a legally marketed class II predicate device with the generic name “Zika virus serological reagents” (
An electronic version of this document and the full text of the revocation are available on the internet at
Having concluded that the criteria for revocation of the Authorization under section 564(g) of the FD&C Act are met, FDA has revoked the EUA for Siemens' ADVIA Centaur Zika test. The revocation in its entirety follows and provides an explanation of the reasons for revocation, as required by section 564(h)(1) of the FD&C Act.
Office of Minority Health, Office of the Secretary, Department of Health and Human Services.
Notice of meeting.
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting conducted as a telephone conference call. This call will be open to the public. Preregistration is required for both public participation and comment. Any individual who wishes to participate in the call should email
The conference call will be held on Friday, September 27, 1:00 p.m. to 3:00 p.m. ET.
Instructions regarding participating in the conference call will be given at the time of preregistration.
Violet Woo, Designated Federal Officer, Advisory Committee on Minority Health, Office of Minority Health, Department of Health and Human Services, Tower Building, 1101 Wootton Parkway, Suite 600, Rockville, Maryland 20852. Phone: 240-453-8222; fax: 240-453-8223; email
In accordance with Public Law 105-392, the ACMH was established to provide advice to the Deputy Assistant Secretary for Minority Health on improving the health of each racial and ethnic minority group and on the development of goals and specific program activities of the OMH.
The topics to be discussed during this meeting will include strategies to address HIV-related health disparities among racial and ethnic minority populations. The recommendations will be given to the Deputy Assistant Secretary for Minority Health to inform OMH and the Office of Infectious Disease and HIV/AIDS Policy of efforts related to the federal
Any members of the public who wish to have electronic or printed material distributed to ACMH members should email
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and/or contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Notice is hereby given of a change in the meeting of the National Institute on Alcohol Abuse and Alcoholism Special Emphasis Panel, November 8, 2019, 8:30 a.m. to 5:00 p.m., National Institute on Alcohol Abuse and Alcoholism, 6700B Rockledge Drive, Bethesda, MD 20817 which was published in the
The meeting notice is amended to change the Contact Person from Dr. Richard A. Rippe to Dr. Beata Buzas. Dr. Buzas may be reached at National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, 6700 B Rockledge Drive, Room 2116, Rockville, MD 20852, 301-443-0800,
National Institutes of Health, HHS.
Notice.
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. to achieve expeditious commercialization of results of federally-funded research and development.
Licensing information may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of Technology Transfer, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-2479; telephone: 301-402-5579. A signed Confidential Disclosure Agreement may be required to receive any unpublished information.
Technology description follows.
Available for licensing and commercial development are patent rights covering a PET imaging method for fungal infections, for example,
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of accreditation and approval of AmSpec LLC (Christiansted, St. Croix, USVI), as a commercial gauger and laboratory.
Notice is hereby given, pursuant to CBP regulations, that AmSpec LLC (Christiansted, St. Croix, USVI), has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of June 5, 2019.
AmSpec LLC (Christiansted, St. Croix, USVI) was approved and accredited as a commercial gauger and laboratory as of June 5, 2019. The next triennial inspection date will be scheduled for June 2022.
Dr. Eugene Bondoc, Laboratories and Scientific Services, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW, Suite 1500N, Washington, DC 20229, tel. 202-344-1060.
Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, that AmSpec LLC, 9010 East Cottage, Suite 3, Christiansted, St. Croix, USVI 00820, has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. AmSpec LLC (Christiansted, St. Croix, USVI) is approved for the following gauging procedures for petroleum and certain petroleum products from the American Petroleum Institute (API):
AmSpec LLC (Christiansted, St. Croix, USVI) is accredited for the following laboratory analysis procedures and methods for petroleum and certain
Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Notice of Order of Succession.
In this notice, the Assistant Secretary for Housing—FH Commissioner designates the Order of Succession for the Office of Housing. This Order of Succession supersedes all prior orders of succession for the Assistant Secretary for Housing—FH Commissioner, including the Order of Succession published on April 20, 2015.
June 20, 2019.
Vance Morris, Acting Associate General Deputy Assistant Secretary, Office of the Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Development, 451 7th Street SW, Room 9100, Washington, DC 20410; telephone number 202-708-2601. (This is not a toll-free number). Persons with hearing or speech impairments may call HUD's toll-free Federal Relay Service at 800-877-8339.
The Assistant Secretary for Housing—FH Commissioner is issuing this Order of Succession of officials authorized to perform the functions and duties of the Assistant Secretary for Housing—FH Commissioner when the Assistant Secretary—FH Commissioner is not available to exercise the powers or perform the duties of the office. This Order of Succession is subject to the provisions of the Federal Vacancies Reform Act of 1998 (5 U.S.C. 3345-3349d).
Today's publication supersedes all prior orders of succession for the Office of Housing, including the Order of Succession notice published on April 20, 2015 (80 FR 21750).
Subject to the provisions of the Federal Vacancies Reform Act of 1998,
These officials shall perform the functions and duties of the office in the order specified herein, and no official shall serve unless all other officials whose positions precede his/hers in this order are unable to act by reason of absence, disability, or vacancy in office.
This Order of Succession supersedes all prior orders of succession for the Office of Housing, including the order of succession published on April 20, 2015 at 80 FR 21750.
Section 7(d), Department of Housing and Urban Development Act, 42 U.S.C. 3535(d).
Fish and Wildlife Service, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the U.S. Fish and Wildlife Service, are proposing to renew an information collection with revisions.
Interested persons are invited to submit comments on or before October 16, 2019.
Send written comments on this information collection request to the Office of Management and Budget's Desk Officer for the Department of the Interior by email at
To request additional information about this ICR, contact Madonna L. Baucum, Service Information Collection Clearance Officer, by email at
In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
On April 30, 2019, we published a
We are again soliciting comments on the information collection request (ICR) that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the Service; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Service enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Service minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Under 50 CFR 14.11, it is unlawful to import or export wildlife or wildlife products at ports other than those designated in 50 CFR 14.12, unless you qualify for an exception. The following exceptions allow qualified individuals, businesses, or scientific organizations to import or export wildlife or wildlife products at a nondesignated port:
(a) To export the wildlife or wildlife products for scientific purposes;
(b) To minimize deterioration or loss; or
(c) To relieve economic hardship.
To request authorization to import or export of wildlife or wildlife products at nondesignated ports, applicants must complete FWS Form 3-200-2. Designated port exception permits can be valid for up to 2 years. We may require a permittee to file a report on activities conducted under authority of the permit.
It is unlawful to import or export wildlife or wildlife products for commercial purposes without first obtaining an import/export license (50 CFR 14.91). Applicants located in the United States must complete FWS Form 3-200-3a to request this license. Foreign applicants that reside or are located outside the United States must complete FWS Form 3-200-3b to request this license.
We use the information collected on FWS Forms 3-200-3a/3b as an enforcement tool and management aid to (a) monitor the international wildlife market and (b) detect trends and changes in the commercial trade of wildlife and wildlife products. Import/export licenses are valid for up to 1 year. We may require a licensee to file a report on activities conducted under authority of the import/export license.
Permittees and licensees must maintain records that accurately describe each importation or exportation of wildlife or wildlife products made under the license, and any additional sale or transfer of the wildlife or wildlife products. In addition, licensees must make these records and the corresponding inventory of wildlife or wildlife products available for our inspection at reasonable times, subject to applicable limitations of law. We believe the burden associated with these recordkeeping requirements is minimal because the records already exist. Importers and exporters must complete FWS Form 3-177 (Declaration for Importation or Exportation of Fish or Wildlife) for all imports or exports of wildlife or wildlife products. This form provides an accurate description of the imports and exports. OMB has approved the information collection for FWS Form 3-177 and assigned OMB Control Number 1018-0012. Normal business practices should produce records (
With this submission, we propose a revision to the previously approved collection of information. The Service will request OMB approval to transfer the below-listed forms currently approved under OMB Control No. 1018-0093, “Federal Fish and Wildlife Permit Applications and Reports—Management Authority; 50 CFR 12, 13, 14, 15, 16, 17, 18, 21, 23,” into this information collection (OMB Control No. 1018-0092):
• FWS Form 3-200-44, “Permit Application Form: Registration of an Agent/Tannery under the Marine Mammal Protection Act (MMPA),” and
• FWS Form 3-200-44a, “Registered Agent/Tannery Bi-Annual Inventory Report.”
The Service's Alaska region manages marine mammals that inhabit Alaskan waters, as well as the Alaska Native hunters and handicrafters. Both the registration of an Agent/Tannery form and the Registered Agent/Tannery bi-annual inventory report form are issued and reviewed by the Office of Law Enforcement in the Alaska Region. As such, it is more appropriate that these forms be transferred to, and approved by OMB, under OMB Control No. 1018-0092, “Federal Fish and Wildlife Applications and Reports—Law Enforcement; 50 CFR 13 and 14.”
We use the information collected on FWS Form 3-200-44 for only the registration of qualified agents and tanneries for polar bear (
Biannually (twice a year) on or before the 10th day of January and July, we require that the permittee submit to the Service FWS Form 3-200-44a, containing detailed activities of each registered agent or registered tannery for each transaction related to Polar bear, Walrus, and Alaskan sea otter. If no transactions occurred, the permittee must submit a negative report.
The associated estimated annual burden of Forms 3-200-44/44a is 45 responses and 42 burden hours. If OMB approves this revision request, we will initiate a revision to OMB Control No. 1018-0093 to remove those two forms to avoid duplication of burden.
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 authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Bureau of Indian Affairs, Interior.
Notice.
This notice publishes the liquor control act of the Shawnee Tribe. The Shawnee Tribe Liquor and Beer Act (Act) regulates and controls the possession, sale, manufacture, and distribution of alcohol in conformity with the laws of the State of Oklahoma for the purpose of generating new Tribal revenues. Enactment of this Act will help provide a source of revenue to strengthen Tribal government, provide for the economic viability of Tribal enterprises, and improve delivery of Tribal government services.
This Act takes effect on September 16, 2019.
Ms. Diane Jobe, Tribal Government Services Officer, Eastern Oklahoma Regional Office, Bureau of Indian Affairs, 3100 West Peak Boulevard, Muskogee, Oklahoma 74402, Telephone: (918) 781-4685, Fax: (918) 781-4649.
Pursuant to the Act of August 15, 1953, Public Law 83-277, 67 Stat. 586, 18 U.S.C. 1161, as interpreted by the Supreme Court in
This notice is published in accordance with the authority delegated by the Secretary of the Interior to the Assistant Secretary—Indian Affairs. I certify that the Shawnee Tribe Business Council duly adopted by Resolution the Shawnee Tribe Liquor and Beer Act by Resolution No. R-08-09-19-B dated August 9, 2019.
SECTION ONE.
Section 7-101.
A. It is the policy of the Tribe to raise revenues through the collection of taxes for the sale and distribution of liquor and beer products within Shawnee Indian Country.
B. The Tribe has a duty to provide for the health, safety, and welfare of its citizens.
C. As part of the Tribe's responsibility to its citizens, the Tribe must regulate and control the distribution, sale, and possession of alcoholic beverages on tribal lands located within Shawnee Indian Country.
D. Except as otherwise required by other applicable laws of the Shawnee Tribe or by any applicable Federal and State law, the provisions and requirements of this Chapter and any rules, regulations and licenses authorized hereunder shall apply to the sale and distribution of liquor and beer products on properties under the jurisdiction of the Tribe.
Section 7-102.
Section 7-103.
Section 7-104.
Section 7-105.
A. “Alcohol” means a substance known as ethyl alcohol, hydrated oxide of ethyl, or spirit of wine, which is produced by the fermentation or distillation of grain, starch, molasses, sugar, or other substances including all dilutions and mixtures of this substance.
B. “Beer” means any beverage of alcohol by volume and obtained by the alcoholic fermentation of an infusion or decoction of barley, or other grain, malt or similar products. “Beer” may or may not contain hops or other vegetable products. “Beer” includes, among other things, beer, ale, stout, lager beer, porter and other malt or brewed liquors, but does not include sake, known as Japanese rice wine.
C. “Beer Outlet” means retail sale business licensed by the Shawnee Tribe selling beer within the Shawnee Indian Country, including all related and associated facilities under the control of the Operator. Moreover, where an Operator's business is carried on as part of the operation of an entertainment or recreational facility, the “Beer Outlet” shall be deemed to include the entertainment or recreational facility and its associated areas.
D. “Commission” means the Tax Commission of the Shawnee Tribe.
E. “Liquor” means the four varieties of liquor commonly referred to as alcohol, spirits, wine and beer, and all fermented, spirituous, vinous or malt liquors or any other intoxicating liquid, solid, semi-solid or other substance patented or not, containing alcohol, spirits, wine or beer, and is intended for oral consumption.
F. “Liquor Outlet” means retail sale business licensed by the Shawnee Tribe selling liquor within the Shawnee Indian Country, including all related and associated facilities under the control of the Operator. Moreover, where an Operator's business is carried on as part of the operation of an entertainment or recreational facility, the “Liquor Outlet” shall be deemed to include the entertainment or recreational facility and its associated areas.
G. “Tribe” means the Shawnee Tribe as established under the Constitution of the Shawnee Tribe, and any agency, corporation, partnerships, component, or subdivisions of the Shawnee Tribe.
H. “Business Council” means the Shawnee Tribe Business Council as constituted by Article IV of the Constitution of the Shawnee Tribe.
I. “Operator” means a person twenty-one (21) years of age or older who is properly licensed by the Commission to operate a Liquor and/or Beer Outlet.
J. “Person” shall have the meaning defined in Chapter One, Section 1-03 of this Title.
K. “Sale” means any transfer, exchange, or barter, in any manner or by any means whatsoever, for a consideration and includes and means all sales made by any person, whether as principal, proprietor or as an agent, servant, or employee, association, partnership, or corporation of liquor or beer products.
L. “Wholesaler” means and includes any person doing any such acts or carrying on any such business or businesses that would require such person to obtain a Wholesaler's License or Licenses hereunder.
M. “Wholesale price” means the established price for which liquor or beer are sold to the Shawnee Tribe or any Operator by the manufacturer or distributor or other reduction.
Section 7-106.
Section 7-201.
Section 7-202.
Section 7-203.
Section 7-301.
A. Administer this Act by exercising general control, management and supervision of all liquor and beer sales, places of sales and sale outlets, as well as exercising all powers necessary to accomplish the purposes of this Act; and,
B. Adopt and enforce rules and regulations in furtherance of the purposes of this Act and in the performance of its administrative functions.
Section 7-302.
A. Business Council Approval of Location. The Business Council shall approve all Liquor and/or Beer Outlet locations on Shawnee Indian Country by way of Tribal Resolution prior to the Commission issuing Licenses to said outlet locations.
B. Business Council Location Review. The Business Council may refuse to approve a Liquor and/or Beer Outlet location on the Shawnee Indian Country, pursuant to Section 7-302 of this Act, if the Business Council has reasonable cause to believe that:
1. The proximity of the Liquor and/or Beer Outlet has a detrimental effect upon a religious, cultural, social or governmental institution established or recognized by the Shawnee Tribe; or
2. The Liquor and/or Beer Outlet is within 100 feet of a residential area; or
3. The Business Council determines it is not in the best interest of the Tribe's health, safety or welfare; or
4. There is any other reason as provided for and by Shawnee Tribe law, custom or regulation.
Section 7-303.
A. Application. Any person twenty-one (21) years of age or older may apply to the Commission for a Liquor and/or Beer Outlet License.
B. Licensing Requirements. The person applying for said License must make a showing once a year and must satisfy the Commission that:
1. He/she is a person of good moral character;
2. He/she has never been convicted of violating any laws prohibiting the traffic in any spirituous, vinous, fermented or
3. He/she has never violated the laws commonly called the “Prohibition laws,” as defined hereunder or under any subsequent regulations; and,
4. He/she has not had any permit or License to sell alcohol, beer or liquor as provided for in § 7-105 hereof revoked by any governmental authority within the previous one (1) year.
C. Processing Application. The Commission shall receive and process applications and be the official representative of the Tribe in all matters related to the receipt of applications, liquor and beer excise tax collections and any other related matters. If the Commission or its authorized representative is satisfied that the applicant is suitable and a responsible person, the Commission or his/her authorized representative may issue a License for the sale of liquor and/or beer products.
D. Application Fee. Each application shall be accompanied by an application fee to be set by regulations of the Commission.
E. Discretionary Licensing. Nothing herein shall be deemed to create a duty or requirement to issue a License. Issuance of a License is discretionary based upon the Commission's determination of the best interests of the Tribe. A License is a privilege, and not a property right, to sell liquor and/or beer products within the jurisdiction of the Shawnee Tribe at licensed locations, but not operate to confer on, vest in, or license any title, interest or estate in Shawnee Tribe real property.
F. Temporary or Emergency Licensing. An applicant for a Liquor and/or Beer Outlet License may apply for a ninety (90) day temporary or emergency License upon showing of good cause for such issuance pending determination upon the regular License application. Such applicant must show they have a valid similar license from another licensing jurisdiction and meet such other written conditions of the Commission as to ensure the health and safety of the public.
Section 7-304.
Section 7-305.
Section 7-306.
A. Failure of an Operator to abide by the requirements of this Act and any additional regulations or requirements imposed by the Commission shall constitute grounds for revocation of the Operator's License as well as enforcement of the penalties provided for in Section 7-701 of this Act.
B. Upon determining that any person licensed by the Tribe to sell liquor and/or beer is for any reason no longer qualified to hold such License or reasonably appears to have violated any terms of this License or Shawnee Tribe regulations, including failure to pay taxes when due and owing, or have been found by any forum of competent jurisdiction, including the Commission, to have violated the terms of the Tribe's or the State of Oklahoma's license or of any provision of this Act, the Commission shall immediately serve written notice upon the Operator that he/she must show cause within ten (10) calendar days as to why his/her License should not be revoked or restricted. The notice shall state the grounds relied upon for the proposed revocation or restriction.
C. If the Operator fails to respond to the notice within ten (10) calendar days of service, the Commission may issue an Order revoking the License as the Commission deems appropriate, effective immediately. The Operator may within the ten (10) calendar day period file with the Commission a written response and request for hearing before the Commission.
D. At the hearing, the Operator may present evidence and argument directed at the issue of whether or not the asserted grounds for the proposed revocation or restriction are in fact true, and whether such grounds justify the revocation or modifications of the License. The Tribe may present evidence as it deems appropriate.
E. The Commission, after considering all of the evidence and arguments, shall issue a written decision either upholding the License, revoking the License or imposing some lesser penalty (such as temporary suspension or fine), and such decision shall be final and conclusive with regard to the Commission. The Commission's fine may be in an amount not to exceed Five-Thousand Dollars ($5,000) per incident and/or violation.
F. The Commission's final decision may be appealed by the Operator to the Shawnee Tribal Court, or appropriate CFR Court, upon posting a bond with the Court Clerk in the amount of the Commission's final hearing assessment or ruling, in compliance with such rules and procedure as generally applicable to court proceedings. Provided, any findings of fact of the Commission are conclusive upon the Court unless clearly contrary to law. The purposes of the Court review are not to substitute the Court's finding of facts or opinion for the Commission's, but to guarantee due process of law. If the Court should rule for the appealing party, the Court may sustain, reverse or order a new hearing giving such guidance for the conduct of such as it deems necessary for a fair hearing. No damages or monies may be awarded against the Commission, the Commission or its staff, nor the Tribe, and its agents, officers and employees in such an action.
Section 7-307.
Section 7-401.
A. Right of Commission to Scrutinize Suppliers. The Operator of any licensed outlet shall keep the Commission informed, in writing, of the identity of the suppliers and/or Wholesalers who supply or are expected to supply liquor and/or beer products to the outlet(s). The Commission may, at its discretion, limit or prohibit the purchase of said products from a supplier or Wholesaler for the following reasons: Non-payment of Shawnee Tribe taxes, bad business practices, or sale of unhealthy supplies. A ten (10) calendar day notice of stopping purchases (“Stop Purchase Order”) shall be given by the Commission whenever purchases from a supplier or Wholesaler are to be discontinued unless there is a health emergency, in which case the Stop Purchase Order may take effect immediately.
B. Freedom of Information from Suppliers/Wholesalers. Operators shall in their purchase of stock and in their business relations with suppliers and Wholesalers cooperate with and assist in the free flow of information and data to the Commission from suppliers and Wholesalers relating to the sales and business arrangements between suppliers and Operators. The Commission may, at his/her discretion, require the receipts from the suppliers of all invoices, bills of lading, billings or documentary receipts of sales to the Operators. All records shall be kept according to Section 7-402. G. of this Act.
Section 7-402.
A. Commission Regulations. The Commission shall adopt regulations that shall supplement this Act and facilitate their enforcement. These regulations shall include prohibitions on sales to minors, where liquor and/or beer may be consumed, persons not allowed to purchase liquor and/or beer, hours and days when outlets may be open for business and any other appropriate matters and controls.
B. Sales to Minors. No person shall give, sell or otherwise supply any liquor and/or beer to any person under the age of twenty-one (21) years of age either for his or her own use or for the use of any other person.
C. Consumption of Liquor and/or Beer upon Licensed Premises. No Operator shall permit any person to open or consume liquor and/or beer on his/her premises and in his/her control unless the Commission allows the consumption of liquor and/or beer and identifies where liquor and/or beer may be consumed on Shawnee Indian Country.
D. Conduct on Licensed Premises.
1. No Operator shall be disorderly, boisterous or intoxicated on the licensed premises or any public premises adjacent thereto which are under his/her control, nor shall he/she permit disorderly, boisterous or intoxicated person to be thereon; nor shall he/she use or allow the use of profane or vulgar language thereon.
2. No Operator shall permit suggestive, lewd or obscene conduct or acts on his/her premises. For the purpose of this Section, suggestive, lewd or obscene conduct or acts shall be those conduct or acts identified as such by Federal, State of Oklahoma and/or the laws of the Tribe.
E. Employment of Minors. No person under the age of twenty-one (21) years of age shall be employed in any service in connection with the sale or handling of liquor or beer, either on a paid or voluntary basis.
F. Operator's Premises Open to Commission Inspection. The premises of all Operators, including vehicles used in connection with liquor and/or beer sales, shall be open during business hours and at all reasonable times to inspection by the Commission.
G. Wholesaler's/Operator's Records. The originals or copies of all sales slips, invoices and other memoranda covering all purchases of liquor and/or beer by the Operator or Wholesaler shall be kept on file in the retail premises of the Operator or Wholesaler purchasing the sales at least five (5) years after each purchase and shall be filed separately and kept apart from all other records, and as nearly as possible, shall be filed in consecutive order and each month's records kept separate so as to render the same readily available for inspection and checking. All cancelled checks, bank statements, and books of accounting, covering and involving the purchase of liquor and/or beer and all memoranda, if any, showing payment of money for liquor and/or beer other than by check shall be likewise preserved for availability for inspection and checking.
H. Records Confidential. All records of the Commission showing the purchase of liquor and/or beer by any individual or group shall be confidential and shall not be inspected except by the Commission or the Commission's representative, or the Tribe's Attorney or Attorney General, or upon order of the Shawnee Tribal Court, or appropriate CFR Court.
Section 7-403.
Section 7-501.
A.
B.
C.
D.
Section 7-502.
A. Inspections. All of the books and other business records of the Liquor and/or Beer Outlet shall be available for inspection and audit by the Commission or its authorized representative during normal business hours and at all other reasonable times, as may be requested by the Commission.
B. Bond for Excise Tax. The excise tax together with reports on forms to be supplied by the Commission shall be remitted to the Commission on a monthly basis unless otherwise specified in writing by the Commission. The Operator shall furnish a satisfactory
Section 7-601.
Section 7-602.
A. Liability. Unless explicitly authorized by Shawnee Tribe statute or regulation, Operators are forbidden to represent or give the impression to any supplier or person with whom he or she does business that he or she is an official representative of the Tribe, Commissioner or the Commission authorized to pledge Shawnee Tribe credit or financial responsibility for any of the expenses of his or her business operation. The Operator shall hold the Tribe harmless from all claims and liability of whatever nature. The Commission shall revoke an Operator's outlet License(s) if said outlet(s) is not operated in a businesslike manner or if it does not remain financially solvent or does not pay its operating expenses and bills before they become delinquent.
B. Insurance. The Operator shall maintain at his or her own expense adequate insurance covering liability, fire, theft, vandalism and other insurable risks. The Commission may establish as a condition of any License, the required insurance limits and any additional coverage deemed advisable, proof of which shall be filed with the Commission.
Section 7-603.
Section 7-701.
A. Criminal Penalties. Any Indian person convicted of committing any violation of this Act shall be subject to punishment of up to one (1) year imprisonment and/or a fine not to exceed Five Thousand Dollars ($5,000). The judicial system of the Shawnee Tribe shall have jurisdiction over said proceeding(s).
B. Civil Liability. Additionally, any person upon committing any violation of any provision of this Act may be subject to civil action for trespass and upon having been determined by the Shawnee Tribal Court, or appropriate CFR Court, to have committed said violation, shall be found to have trespassed upon the lands of the Tribe and shall be assessed such damages as the Court deems appropriate in the circumstances. The Court also has jurisdiction to enforce any fine, penalty, suspension, revocation or other enforcement action of the Commission. Any Commission action that was not timely appealed is conclusively deemed valid.
C. Any person suspected or having violated any provision of this Act shall, in addition to any other penalty imposed hereunder, be required to surrender any liquor and/or beer products in the person's possession to the officer making the complaint. The surrendered beverages, if previously unopened, shall only be returned upon a finding by the Shawnee Tribal Court, or appropriate CFR Court, after trial or proper judicial proceeding, that the individual committed no violation of this Act.
D. Any Operator who violates the provisions set forth herein shall forfeit all of the remaining stock in the outlet(s). The Commission shall be empowered to seize forfeited products.
E. Any stock, goods or other items subject to this Act that have not been registered, licensed or taxes paid shall be contraband and subject to immediate confiscation by the Commission or his/her employees or agents; provided that within fifteen (15) calendar days of the seizure the Commission shall cause to be filed an action against such property alleging the reason for the seizure or confiscation and upon proof, the Shawnee Tribal Court, or appropriate CFR Court, shall order the property forfeited and vested with the Tribe.
SECTION TWO.
Bureau of Land Management, Interior.
60-Day notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, the Bureau of Land Management (BLM) is proposing to renew an information collection with revisions.
Please submit comments on the proposed information collection by November 15, 2019.
Comments may be submitted by mail, fax, or electronic mail.
Please indicate “Attn: 1004-0168” regardless of the form of your comments.
Dustin Wharton at 541-471-6659. Persons who use a telecommunication device for the deaf may call the Federal Relay Service at 1-800-877-8339, to leave a message for Mr. Wharton.
OMB regulations at 5 CFR part 1320, which implement provisions of the PRA (44 U.S.C. 3501-3521), require that interested members of the public and affected agencies be given an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d) and 1320.12(a)). This notice identifies an information collection that the BLM plans to submit to OMB for approval. The PRA provides that an agency may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. Until OMB approves a collection of information, you are not obligated to respond.
The BLM will request a 3-year term of approval for this information collection activity. Comments are invited on: (1) The need for the collection of information for the performance of the functions of the agency; (2) the accuracy of the agency's burden estimates; (3)
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
The following information pertains to this request:
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 authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Notice is hereby given pursuant to the Antitrust Procedures and Penalties Act, 15 U.S.C. 16(b)-(h), that a proposed Final Judgment, Stipulation, and Competitive Impact Statement have been filed with the United States District Court for the District of Columbia in
Copies of the Complaint, proposed Final Judgment, and Competitive Impact Statement are available for inspection on the Antitrust Division's website at
Public comment is invited within 60 days of the date of this notice. Such comments, including the name of the submitter, and responses thereto, will be posted on the Antitrust Division's website, filed with the Court, and, under certain circumstances, published in the
The United States of America, Plaintiff, by its attorneys, acting under the direction of the Attorney General of the United States and at the request of the Federal Trade Commission, brings this civil antitrust action to obtain monetary relief in the form of civil penalties and injunctive relief against Defendants Third Point Offshore Fund, Ltd. (“Third Point Offshore”), Third Point Ultra Ltd. (“Third Point Ultra”), Third Point Partners Qualified L.P. (“Third Point Partners”) (collectively, “Defendant Funds”) and Third Point LLC (collectively with Defendant Funds, “Defendants”). Plaintiff alleges as follows:
1. The Hart-Scott-Rodino Antitrust Improvements Act of 1976, 15 U.S.C. § 18a (“HSR Act” or “Act”) is an essential part of modern antitrust enforcement. It requires the buyer and the seller of voting securities or assets in excess of a certain value to notify the Department of Justice and the Federal Trade Commission and to observe a waiting period prior to consummating the acquisition. This waiting period provides the federal antitrust agencies with an opportunity to investigate and to seek an injunction to prevent the consummation of acquisitions that are likely to be anticompetitive.
2. Each Defendant Fund violated the HSR Act's notice and waiting requirements when it acquired voting securities of DowDuPont Inc. (“DowDuPont”) on August 31, 2017, as a result of the consolidation of Dow Chemical Company (“Dow”) and E.I du Pont de Nemours and Company (“DuPont”).
3. The Court should assess an appropriate civil penalty and injunctive relief for these violations of the HSR Act's requirements.
4. This Court has jurisdiction over Defendants and over the subject matter of this action pursuant to Section 7A(g) of the Clayton Act, 15 U.S.C. § 18a(g), and pursuant to 28 U.S.C. §§ 1331, 1337(a), 1345, and 1355, and over Defendants by virtue of Defendants' consent, in the Stipulation relating hereto, to the maintenance of this action and entry of the Final Judgment in this District.
5. Venue is properly based in this District by virtue of Defendants' consent, in the Stipulation relating hereto, to the maintenance of this action and entry of the Final Judgment in this District.
6. Defendant Third Point Offshore is an offshore fund organized under the laws of the Cayman Islands with its registered office at Walkers Corporate Limited, Corporate Centre, 27 Hospital Road, George Town, Grand Cayman KY1-9008, Cayman Islands.
7. Defendant Third Point Ultra is an offshore fund organized under the laws of the British Virgin Islands with its registered office at Maples Corporate Services (BVI) Ltd., Kingston Chambers, P.O. Box 173, Road Town, Tortola, British Virgin Islands. The Investment Manager of Defendant Third Point Ultra has its office at 390 Park Avenue, 19th Floor, New York, NY 10022.
8. Defendant Third Point Partners is a limited partnership organized under the laws of the State of Delaware, with its principal place of business at Corporation Trust Center, 1209 Orange Street, Wilmington, DE 19801.
9. Defendant Third Point LLC is a limited liability company organized under the laws of the State of Delaware, with its principal place of business at 390 Park Avenue, 19th Floor, New York, NY 10022. Defendant Third Point LLC makes all the investment decisions on behalf of the Defendant Funds, including deciding whether to file notifications pursuant to the HSR Act and preparing the notification forms on behalf of each of the Defendant Funds.
10. Defendants are engaged in commence, or in activities affecting commerce, within the meaning of Section 1 of the Clayton Act, 15 U.S.C. § 12, and Section 7A(a)(1) of the Clayton Act, 15 U.S.C. §18a(a)(1). At all times relevant to this Complaint, each Defendant had total assets in excess of $16.2 million.
11. DowDupont is a corporation organized under the laws of the State of Delaware with its principal place of business at 2030 Dow Center, Midland, MI 48674. DowDuPont is engaged in commerce, or in activities affecting commerce, within the meaning of Section 1 of the Clayton Act, 15 U.S.C. § 12, and Section 7A(a)(1) of the Clayton Act, 15 U.S.C. §18a(a)(1). At all times relevant to this Complaint, DowDuPont had annual net sales in excess of $161.5 million.
12. The HSR Act requires certain acquiring persons and certain persons whose voting securities or assets are acquired to file notifications with the federal antitrust agencies and to observe a waiting period before consummating certain acquisitions of voting securities or assets. 15 U.S.C. § 18a(a) and (b). The HSR Act's notification and waiting period requirements are intended to give the federal antitrust agencies prior notice of, and information about, proposed transactions. The waiting period is intended to provide the federal antitrust agencies with an opportunity to investigate a proposed transaction and to determine whether to seek an injunction to prevent the consummation of a transaction that may violate the antitrust laws.
13. The HSR Act's notification and waiting period requirements apply to acquisitions that meet the HSR Act's thresholds, which are adjusted annually. During the period of 2017 relevant to this Complaint, the HSR Act's reporting and waiting period requirements applied to transactions that would result in the acquiring person holding more than $80.8 million of voting securities, non-corporate interests, or assets, if certain size of person tests were met, except for certain exempted transactions.
14. Pursuant to Section 7A(d)(2) of the HSR Act, 15 U.S.C. § 18a(d)(2), the Federal Trade Commission promulgated rules to carry out the purpose of the HSR Act. 16 C.F.R. §§ 801-03 (“HSR Rules”). The HSR Rules, among other things, define terms contained in the HSR Act.
15. Section 801.2(a) of the HSR Rules, 16 C.F.R. § 801.2(a), provides that “[a]ny person which, as a result of an acquisition, will hold voting securities” is deemed an “acquiring person.”
16. Section 801.1(a)(1) of the HSR Rules, 16 C.F.R. § 801.1(a)(1), provides that the term “person” means “an ultimate parent entity and all entities which it controls directly or indirectly.”
17. Section 801.1(a)(3) of the HSR Rules, 16 C.F.R. § 801.1(a)(3), provides that the term “ultimate parent entity” means “an entity which is not controlled by any other entity.”
18. Section 801.2(d)(1)(i) of the HSR Rules, 16 C.F.R. § 801.2(d)(1)(i), provides that “mergers and consolidations are transactions subject to the act and shall be treated as acquisitions of voting securities.”
19. Section 801.13(a) of the HSR Rules, 16 C.F.R. § 801.13(a), provides that “all voting securities of the issuer which will be held by the acquiring person after the consummation of an acquisition shall be deemed voting securities held as a result of the acquisition.”
20. Section 802.21 of the HSR Rules, 16 C.F.R. § 802.21, provides that, when a person files under the HSR Act to acquire voting securities from an issuer and observes the waiting period, that person may acquire additional voting securities of the same issuer for five years after the end of the waiting period so long as it does not exceed any higher threshold as a result of the combined purchases.
21. Section 7A(g)(1) of the Clayton Act, 15 U.S.C. § 18a(g)(1), provides that any person, or any officer, director, or partner thereof, who fails to comply with any provision of the HSR Act is liable to the United States for a civil penalty for each day during which such person is in violation. For violations occurring on or after November 2, 2015, and assessed after August 1, 2016, the maximum amount of civil penalty is $40,000 per day, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, Pub. L. 114-74, § 701 (further amending the Federal Civil Penalty Inflation Adjustment Act of 1990, 28 U.S.C. § 2461 note), and Federal Trade Commission Rule 1.98, 16 C.F.R. § 1.98, 81 Fed. Reg. 42,476 (June 30, 2016). As of January 22, 2018, the maximum penalty amount was further increased to $41,484 per day for civil penalties assessed after that date. 83 Fed. Reg. 2903 (Jan. 22, 2018).
22. Section 7A(g)(2) of the Clayton Act, 15 U.S.C. § 18a(g)(2), provides that if any person fails substantially to comply with the notification requirement under the HSR Act, a
23. Plaintiff alleges and incorporates paragraphs 1 through 22 as if set forth fully herein.
24. On December 11, 2015, Dow and DuPont entered into a Merger Agreement pursuant to which Dow and DuPont would consolidate into a single company, to be called DowDuPont.
25. On June 10, 2106, Dow and DuPont issued their Final Proxy Statement/Prospectus for the consolidation. That document disclosed that, upon completion of the transaction, Dow and DuPont would cease to have their common stock publicly traded and that shareholders would own shares in DowDuPont and would not directly own any shares of Dow or DuPont.
26. On June 15, 2017, Dow and DuPont issued a joint press release stating that they had received antitrust clearance from the U.S. Department of Justice and that the transaction was on track to close in August 2017.
27. On August 4, 2017, Dow and DuPont issued a joint press release setting a closing date of August 31, 2017 for the transaction. The press release also stated that shares of Dow and DuPont would cease trading at the close of the New York Stock Exchange on August 31 and shares of DowDuPont will begin trading on September 1, 2017.
28. As of August 31, 2017, Defendant Third Point Offshore held 6,446,300 voting securities of Dow, Defendant Third Point Ultra held 4,376,813 voting securities of Dow, and Defendant Third Point Partners held 2,540,700 voting securities of Dow.
29. On August 31, 2017, Dow and DuPont completed the consolidation pursuant to the Merger Agreement of December 11, 2015, as amended on March 31, 2017. As a result of the consolidation, all holders of Dow and DuPont voting securities received voting securities of DowDuPont.
30. On August 31, 2017, each Defendant Fund received voting securities of DowDuPont valued in excess of $80.8 million. Defendant Third Point Offshore acquired 6,446,300 voting securities of DowDuPont valued at approximately $429.6 million. Defendant Third Point Ultra acquired 4,376,813 voting securities of DowDuPont valued at approximately $291.7 million. Defendant Third Point Partners acquired 2,540,700 voting securities of DowDuPont valued at approximately $169.3 million.
31. Each Defendant Fund is its own ultimate parent entity within the meaning of the HSR Rules and had its own obligation to comply with the notification and waiting period requirements of the HSR Act and the HSR Rules.
32. The transactions described in Paragraph 30 were subject to the notification and waiting periods of the HSR Act and the HSR Rules. The HSR Act and HSR Rules in effect during the time period relevant to this proceeding required that each Defendant Fund file a notification and report form with the Department of Justice and the Federal Trade Commission and observe a waiting period before acquiring and holding an aggregate total amount of voting securities of DowDuPont in excess of $80.8 million.
33. Previously, on April 7, 2014, each Defendant Fund had filed under the HSR Act to acquire voting securities of Dow and had observed the waiting period. Section 802.21 of the HSR Rules does not exempt the Defendant Funds' acquisitions of DowDuPont voting securities because DowDuPont is not the same issuer as Dow within the meaning of the HSR Rules. Among other things, for example, DowDuPont competes in additional lines of business from those in which Dow competed.
34. Although required to do so, each Defendant Fund failed to file and observe the waiting period prior to acquiring DowDuPont voting securities.
35. Defendant Third Point LLC had the power and authority to file a notification under the HSR Act on behalf of each of the Defendant Funds.
36. On November 8, 2017, each Defendant Fund filed a notification and report form under the HSR Act with the Department of Justice and the Federal Trade Commission reflecting their acquisitions of DowDuPont voting securities. The waiting period relating to these filings expired on December 8, 2017.
37. Each Defendant Fund was in violation of the HSR Act each day during the period beginning on August 31, 2017, and ending on December 8, 2017.
38. Defendants are currently under a court decree, also in the District Court of the District of Columbia, resulting from allegations that they previously violated the HSR Act in connection with acquisitions of voting securities of Yahoo! Inc. (“Yahoo”). Specifically, on August 24, 2015, the United States filed a complaint for equitable relief alleging that Defendants' acquisitions of Yahoo voting securities in August and September of 2011 violated the HSR Act. At the same time, the United States filed a Stipulation signed by Defendants and a proposed Final Judgment that included provisions imposing certain injunctive relief against Defendants, including the requirement that Defendants maintain a compliance program. That Final Judgment was entered by that court on December 18, 2015.
Wherefore, the Plaintiff requests:
1. That the Court adjudge and decree that each Defendant Fund violated the HSR Act, 15 U.S.C. § 18a, as alleged in this Complaint and that each Defendant Fund was in violation of the Act on each day of the period from August 31, 2017, through December 8, 2017;
2. That the Court order each Defendant Fund to pay to the United States an appropriate civil penalty as provided by the HSR Act, 15 U.S.C. § 18a(g)(1), the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, Pub. L. 114-74, § 701 (further amending the Federal Civil Penalties Inflation Adjustment Act of 1990, 28 U.S.C. § 2461 note), and Federal Trade Commission Rule 1.98, 16 C.F.R. § 1.98, 84 FR 3980 (Feb. 14, 2019);
3. That the Court adjudge and decree that Defendant Third Point LLC had the power and authority to prevent the violations by the Defendant Funds and that relief against Third Point LLC is necessary and appropriate in order to ensure future compliance with the HSR Act by the Defendant Funds;
4. That the Court issue an appropriate injunction preventing future violations by Defendants as provided by the HSR Act, 15 U.S.C. § 18a(g)(2);
5. That the Court order such other and further relief as the Court may deem just and proper; and
6. That the Court award the Plaintiff its costs of this suit.
WHEREAS, the United States of America filed its Complaint on August 28, 2019, alleging that Defendants Third Point Offshore Fund, Ltd., Third Point Ultra Ltd., and Third Point Partners Qualified L.P. (collectively, “Third Point Funds” or “Defendant Funds”) violated Section 7A of the Clayton Act (15 U.S.C. § 18a, commonly known as the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the “HSR Act”)), and the United States and Defendants Third Point Funds and Third Point LLC (collectively, “Defendants”), by their respective attorneys, have consented to the entry of this Final Judgment without trial or adjudication of any issue of fact or law, and without this Final Judgment constituting any evidence against, or any admission by, any party regarding any such issue of fact or law;
AND WHEREAS Defendants agree to be bound by the provisions of this Final Judgment pending its approval by the Court;
NOW, THEREFORE, before any testimony is taken, and without trial or adjudication of any issue of fact or law, and upon the consent of the parties, it is ORDERED, ADJUDGED AND DECREED;
This Court has jurisdiction over the subject matter of this action. The Defendants consent solely for the purpose of this action and the entry of this Final Judgment that this Court has jurisdiction over each of the parties to this action and that the Complaint states a claim upon which relief may be granted against Defendants under Section 7A of the Clayton Act, as amended (15 U.S.C. § 18a).
(A) “Consolidation” shall have the meaning of “consolidation” as used in 16 C.F.R. § 801.2.
(B) “Consolidated Issuer” means an Issuer that is formed by a Consolidation.
(C) “
(D) “Issuer” means a legal entity that issues Voting Securities.
(E) “Person” means any natural person.
(F) “Regulation” shall mean any rule, regulation, statement, or interpretation under the HSR Act that has legal effect with respect to the implementation or application of the HSR Act or any section within 16 C.F.R. §§ 801-803.
(G) “Third Point LLC” means Defendant Third Point LLC, a limited liability company organized under the laws of the State of Delaware, with its principal place of business at 390 Park Avenue, 19th Floor, New York, NY 10022; its successors and assigns; and its subsidiaries, divisions, groups, affiliates, partnerships, and joint ventures, and their directors, officers, managers, agents, and employees.
(H) “Third Point Offshore Fund, Ltd.” means Defendant Third Point Offshore Fund, Ltd., an exempted company organized under the laws of the Cayman Islands, with its registered office at Walkers Corporate Limited, Corporate Centre, 27 Hospital Road, George Town, Grand Cayman KY1-9008, Cayman Islands; its successors and assigns; and its subsidiaries, divisions, groups, affiliates, partnerships, and joint ventures, and their directors, officers, managers, agents, and employees.
(I) “Third Point Partners Qualified L.P.” means Defendant Third Point Partners Qualified L.P., a limited partnership organized under the laws of the State of Delaware, with its registered address at Corporation Trust Center, 1209 Orange Street, Wilmington, Delaware 19801; its successors and assigns; and its subsidiaries, divisions, groups, affiliates, partnerships, and joint ventures, and their directors, officers, managers, agents, and employees.
(J) “Third Point Ultra Ltd.” means Defendant Third Point Ultra Ltd., an international business company organized under the laws of the British Virgin Islands, with its registered office at Maples Corporate Services (BVI) Ltd., Kingston Chambers, P.O. Box 173, Road Town, Tortola, British Virgin Islands; its successors and assigns; and its subsidiaries, divisions, groups, affiliates, partnerships, and joint ventures, and their directors, officers, managers, agents, and employees.
(K) Other capitalized terms have the meanings as defined in the HSR Act and Regulations promulgated thereunder, 16 C.F.R. §§ 801-803.
(A) This Final Judgment applies to all Defendants, as defined above, and to all other Persons and entities who are in active concert or participation with any of the foregoing with respect to conduct prohibited in Paragraph IV when the relevant Persons or entities have received actual notice of this Final Judgment by personal service or otherwise.
(B) Pursuant to Rule 506(d)(2)(iii), 17 C.F.R. § 230.506(d)(2)(iii), as promulgated under the Securities Act of 1933, 15 U.S.C. § 77a,
Each Defendant is enjoined from acquiring Voting Securities of a Consolidated Issuer in exchange for Voting Securities of any Issuer that was a party to the Consolidation when:
(A) The acquisition of the Voting Securities of the Consolidated Issuer would meet the notification requirements of the HSR Act;
(B) Defendant's acquisition of such Voting Securities would not be exempt from the reporting and waiting requirements of the HSR Act; and
(C) Defendant has not fulfilled the reporting and waiting requirements of the HSR Act with respect to the acquisition of such Voting Securities.
(A) Judgment is hereby entered in this matter in favor of Plaintiff and against the Defendants and, pursuant to Section 7A(g)(1) of the Clayton Act, 15 U.S.C. § 18a(g)(1), and the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, Pub. L. 114-74 § 701, codified at 28 U.S.C. § 1 (amending the Federal Civil Penalties Inflation Adjustment Act of 1990, Pub. L. 101-410 (codified at 28 U.S.C. § 2461 note)), and Federal Trade Commission Rule 1.98, 16 C.F.R. § 1.98, 81 Fed. Reg. 42, 476 (June 30, 2016), Defendant Funds are hereby ordered, jointly and severally, to pay a single civil penalty in the amount of six hundred nine thousand, eight hundred ten dollars and no cents ($609,810.00). Payment of the civil penalty ordered hereby shall be made by wire transfer of
(B) Defendant Funds shall pay the full amount of the civil penalty within thirty (30) days of entry of this Final Judgment. In the event of a default or delay in payment, interest at the rate of 18 percent per annum shall accrue thereon from the date of the default or delay to the date of payment.
(A) For the purpose of determining or securing compliance with this Final Judgment, and subject to any legally recognized privilege, duly authorized representatives of the United States, including agents and consultants retained by the United States, shall, upon written request of a duly authorized representative of the Assistant Attorney General in charge of the Antitrust Division, and on reasonable notice to Defendants, be permitted:
(1) access during Defendants' office hours to inspect and copy, or at the option of the United States, to require Defendants to provide electronic copies of all books, ledgers, accounts, records, data, and documents in the possession, custody, or control of Defendants, relating to any matters contained in this Final Judgment; and
(2) to interview, either informally or on the record, Defendants' directors, officers, employees, agents, or other Persons, who may have their individual counsel present, regarding such matters. The interviews shall be subject to the reasonable convenience of the interviewee and without restraint or interference by Defendants.
(B) Upon written request of a duly authorized representative of the Assistant Attorney General in charge of the Antitrust Division, Defendants shall submit written reports or responses to written interrogatories, under oath if requested, relating to any of the matters contained in this Final Judgment as may be requested.
(C) No information or documents obtained by the means provided in this Final Judgment shall be divulged by the United States to any person other than an authorized representative of the executive branch of the United States or of the Federal Trade Commission, except in the course of legal proceedings to which the United States is a party (including grand jury proceedings), or for the purpose of securing compliance with this Final Judgment, or as otherwise required by law.
(D) If, at the time information or documents are furnished by Defendants to the United States, Defendants represent and identify in writing the material in any such information or documents to which a claim of protection may be asserted under Rule 26(c)(1) of the Federal Rules of Civil Procedure, and Defendants mark each pertinent page of such material, “Subject to claim of protection under Rule 26(c)(1) of the Federal Rules of Civil Procedure,” then the United States shall give Defendants ten (10) calendar days' notice prior to divulging such material in any legal proceeding (other than a grand jury proceeding).
This Court retains jurisdiction to enable any party to this Final Judgment to apply to this Court at any time for such further orders and directions as may be necessary or appropriate to carry out or construe this Final Judgment, to modify or terminate any of its provisions, to enforce compliance, and to punish any violations of its provisions.
(A) The United States retains and reserves all rights to enforce the provisions of this Final Judgment, including the right to seek an order of contempt from this Court. Defendants agree that in any civil contempt action, any motion to show cause, or any similar action brought by the United States regarding an alleged civil violation of this Final Judgment, the United States may establish a civil violation of the decree and the appropriateness of any remedy therefor by a preponderance of the evidence, and Defendants waive any argument that a different standard of proof should apply.
(B) The Final Judgment should be interpreted to give full effect to the procompetitive purposes of the antitrust laws, including the HSR Act and Regulations promulgated thereunder. Defendants agree that they may be held in contempt of, and that the Court may enforce, any provision of this Final Judgment that, as interpreted by the Court in light of these procompetitive principles and applying ordinary tools of interpretation, is stated specifically and in reasonable detail, whether or not it is clear and unambiguous on its face. In any such interpretation, the terms of this Final Judgment should not be construed against either party as the drafter.
(C) In any enforcement proceeding in which the Court finds that the Defendants have violated this Final Judgment, the United States may apply to the Court for a one-time extension of this Final Judgment, together with such other relief as may be appropriate. In connection with any successful effort by the United States to enforce this Final Judgment against a Defendant, whether litigated or resolved prior to litigation, that Defendant agrees to reimburse the United States for the fees and expenses of its attorneys, as well as any other costs including experts' fees, incurred in connection with that enforcement effort, including in the investigation of the potential violation.
Unless the Court grants an extension, this Final Judgment shall expire five (5) years from the date of its entry, except that:
(A) after three (3) years from the date of its entry, this Final Judgment may be terminated upon notice by the United States to the Court and Defendants that the civil penalty has been paid and that the continuation of the Final Judgment no longer is necessary or in the public interest; or
(B) if, during any part of the term of this Final Judgment, a
Each party shall bear its own costs.
Entry of this Final Judgment is in the public interest. The parties have complied with the requirements of the Antitrust Procedures and Penalties Act, 15 U.S.C. § 16, including making available to the public copies of this Final Judgment, the Competitive Impact Statement, any comments thereon, and
Plaintiff United States of America (“United States”), pursuant to Section 2(b) of the Antitrust Procedures and Penalties Act (“APPA”), 15 U.S.C. § 16(b)-(h), files this Competitive Impact Statement relating to the proposed Final Judgment submitted for entry in this civil antitrust proceeding.
On August 28, 2019, the United States filed a Complaint against Defendants Third Point Offshore Fund, Ltd. (“Third Point Offshore”), Third Point Ultra, Ltd. (“Third Point Ultra”), Third Point Partners Qualified L.P. (“Third Point Partners”) (collectively, “Defendant Funds”) and Third Point LLC (collectively with Defendant Funds, “Defendants”), related to Defendant Funds' acquisitions of voting securities of DowDuPont Inc. (“DowDuPont”) on August 31, 2017. The Complaint alleges that Defendants violated Section 7A of the Clayton Act, 15 U.S.C. § 18a, commonly known as the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the “HSR Act”). The HSR Act provides that “no person shall acquire, directly or indirectly, any voting securities or assets of any person” exceeding certain thresholds until that person has filed pre-acquisition notification and report forms with the Department of Justice and the Federal Trade Commission (collectively, the “federal antitrust agencies” or “agencies”) and the post-filing waiting period has expired. 15 U.S.C. § 18a(a). A key purpose of the notification and waiting period requirements is to protect consumers and competition from potentially anticompetitive transactions by providing the agencies an opportunity to conduct an antitrust review of proposed transactions before they are consummated.
The Complaint alleges that each Defendant Fund acquired voting securities of DowDuPont in excess of the then-applicable statutory threshold ($80.8 million at the time of acquisition) without making the required pre-acquisition HSR Act filings with the agencies and without observing the waiting period, and that each Defendant Fund and DowDuPont met the applicable statutory size of person thresholds.
At the same time the Complaint was filed in the present action, the United States also filed a Stipulation and proposed Final Judgment that eliminates the need for a trial in this case. The proposed Final Judgment is designed to address the violation alleged in the Complaint and deter Defendants' HSR Act violations and deter violations by similarly situated entities in the future. Under the proposed Final Judgment, Defendants must pay a civil penalty to the United States in the amount of $609,810 and are subject to an injunction against future violations.
The United States and Defendants have stipulated that the proposed Final Judgment may be entered after compliance with the APPA, unless the United States first withdraws its consent. Entry of the proposed Final Judgment would terminate this case, except that the Court would retain jurisdiction to construe, modify, or enforce the provisions of the proposed Final Judgment and punish violations thereof.
Third Point LLC is a New York-based financial investment firm managed by Daniel S. Loeb.
On December 11, 2015, the Dow Chemical Company (“Dow”) and E.I. du Pont de Nemours and Company (“DuPont”) entered into a Merger Agreement pursuant to which Dow and DuPont would consolidate into a single company, to be called DowDuPont Inc. On June 10, 2106, Dow and DuPont issued their Final Proxy Statement/Prospectus for the consolidation. That document disclosed that, upon completion of the transaction, Dow and DuPont would cease to have their common stock publicly traded and that shareholders would own shares in DowDuPont and would not directly own any shares of Dow and/or DuPont. On June 15, 2017, Dow and DuPont issued a joint press release stating that they had received antitrust clearance from the U.S. Department of Justice and that the transaction was on track to close in August 2017. On August 4, 2017, Dow and DuPont issued a joint press release setting the closing date of August 31, 2017 for the transaction. The press release also stated that shares of Dow and DuPont would cease trading at the close of the New York Stock Exchange on August 31, and shares of DowDuPont will begin trading on September 1, 2017.
As of August 31, 2017, Defendant Third Point Offshore held 6,446,300 voting securities of Dow; Defendant Third Point Ultra held 4,376,813 voting securities of Dow; and Defendant Third Point Partners held 2,540,700 voting securities of Dow. On August 31, 2017, Dow and DuPont completed the consolidation pursuant to a Merger Agreement dated December 11, 2015, as amended on March 31, 2017. As a result of the consolidation, all holders of Dow and DuPont voting securities received voting securities of DowDuPont.
On August 31, 2017, each Defendant Fund received voting securities of DowDuPont valued in excess of $80.8 million. Defendant Third Point Offshore acquired 6,446,300 voting securities of DowDuPont valued at approximately $429.6 million. Defendant Third Point Ultra acquired 4,376,813 voting securities of DowDuPont valued at approximately $291.7 million. Defendant Third Point Partners acquired 2,540,700 voting securities of DowDuPont valued at approximately $169.3 million. Each Defendant Fund is its own UPE within the meaning of the HSR Rules and had its own obligation to comply with the notification and waiting period requirements of the HSR Act and the HSR Rules.
The transactions described above were subject to the notification and waiting periods of the HSR Act. The
Previously, on April 7, 2014, each Defendant Fund had filed under the HSR Act to acquire voting securities of Dow and had observed the waiting period. Under Section 802.21 of the HSR Rules, Defendants were permitted for the subsequent five years to acquire additional voting securities of Dow without making another HSR Act filing so long as they did not exceed the next-higher threshold. However, Section 802.21 does not exempt Defendant Funds' acquisitions of DowDuPont voting securities because DowDuPont is not the same issuer as Dow within the meaning of the HSR Rules. Among other things, DowDuPont competes in additional lines of business from those in which Dow competed.
Although required to do so, each Defendant Fund failed to file and observe the waiting period prior to acquiring DowDuPont voting securities. Defendant Third Point LLC had the power and authority to file a notification under the HSR Act on behalf of each of Defendant Funds.
On November 8, 2017, each Defendant Fund filed a notification and report form under the HSR Act with the Department of Justice and the Federal Trade Commission to cover their acquisitions of DowDuPont voting securities. The waiting period relating to these filings expired on December 8, 2017. Each Defendant Fund was in violation of the HSR Act each day during the period beginning on August 31, 2017, and ending on December 8, 2017.
The Complaint further alleges that Defendants' August 31, 2017, HSR Act violation was not the first time Defendants had failed to observe the HSR Act's notification and waiting period requirements. Defendants are currently under a court decree resulting from allegations that they previously violated the HSR Act in connection with acquisitions of voting securities of Yahoo! Inc. (“Yahoo”). Specifically, on August 24, 2015, the United States filed a complaint for equitable relief alleging that Defendants' acquisitions of Yahoo voting securities in August and September 2011 violated the HSR Act. At the same time, the United States filed a Stipulation signed by Defendants and a proposed Final Judgment that would impose certain injunctive relief against Defendants, including the requirement that Defendants maintain a compliance program. The Final Judgment was entered by the court on December 18, 2015.
The proposed Final Judgment imposes a $609,810 civil penalty and an injunction against future violations designed to address the violation alleged in the Complaint and deter Defendants and others from violating the HSR Act. The United States adjusted the penalty downward from the maximum permitted under the HSR Act because the violation was inadvertent, Defendants promptly self-reported the violation after discovery, and Defendants are willing to resolve the matter by consent decree and avoid prolonged investigation and litigation. The relief will have a beneficial effect on competition because the agencies will be properly notified of future acquisitions, in accordance with the law. At the same time, neither the penalty nor the injunctive relief will have any adverse effect on competition.
There is no private antitrust action for HSR Act violations; therefore, entry of the proposed Final Judgment will neither impair nor assist the bringing of any private antitrust action.
The United States and Defendants have stipulated that the proposed Final Judgment may be entered by the Court after compliance with the provisions of the APPA, provided that the United States has not withdrawn its consent. The APPA conditions entry upon the Court's determination that the proposed Final Judgment is in the public interest.
The APPA provides a period of at least sixty (60) days preceding the effective date of the proposed Final Judgment within which any person may submit to the United States written comments regarding the proposed Final Judgment. Any person who wishes to comment should do so within sixty (60) days of the date of publication of this Competitive Impact Statement in the
The proposed Final Judgment provides that the Court retains jurisdiction over this action, and the parties may apply to the Court for any order necessary or appropriate for the modification, interpretation, or enforcement of the Final Judgment.
The United States considered, as an alternative to the proposed Final Judgment, a full trial on the merits against Defendants. The United States is satisfied, however, that the proposed relief is an appropriate remedy in this matter. Given the facts of this case, including Defendants' self-reporting of the violation and willingness to settle this matter, the United States is satisfied that the proposed civil penalty and injunction are sufficient to address the violation alleged in the Complaint and to deter violations by similarly situated entities in the future, without the time, expense, and uncertainty of a full trial on the merits.
The Clayton Act, as amended by the APPA, requires that proposed consent judgments in antitrust cases brought by the United States be subject to a 60-day comment period, after which the court shall determine whether entry of the proposed Final Judgment “is in the public interest.” 15 U.S.C. § 16(e)(1). In making that determination, the court, in accordance with the statute as amended in 2004, is required to consider:
As the United States Court of Appeals for the District of Columbia Circuit has held, under the APPA a court considers, among other things, the relationship between the remedy secured and the specific allegations in the government's complaint, whether the Final Judgment is sufficiently clear, whether its enforcement mechanisms are sufficient, and whether the Final Judgment may positively harm third parties.
The United States' predictions with respect to the efficacy of the remedy are to be afforded deference by the Court.
Moreover, the court's role under the APPA is limited to reviewing the remedy in relationship to the violations that the United States has alleged in its complaint, and does not authorize the court to “construct [its] own hypothetical case and then evaluate the decree against that case.”
In its 2004 amendments to the APPA,
There are no determinative materials or documents within the meaning of the APPA that were considered by the United States in formulating the proposed Final Judgment.
On September 10, 2019, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the District of Arizona in the lawsuit entitled
The United States filed this civil enforcement action under the federal Clean Air Act. The United States' complaint seeks injunctive relief and civil penalties for violations of the regulations that govern emissions from the defendant's sulfuric acid manufacturing facility in Axis, Alabama. The proposed consent decree resolves the claims alleged in the complaint and requires the defendant to perform injunctive relief that will significantly reduce emissions of sulfur dioxide and sulfuric acid mist, as well as other air pollutants, at its facility, and to pay a civil penalty of $300,000. Additionally, the proposed consent decree requires the defendant to perform an environmental mitigation project that will benefit communities adversely affected by pollution from its facility.
The publication of this notice opens a period for public comment on the proposed consent decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to
During the public comment period, the proposed consent decree may be examined and downloaded at this Justice Department website:
Please enclose a check or money order for $16.00 (25 cents per page reproduction cost) payable to the United States Treasury.
Bureau of Justice Statistics, Department of Justice.
30-Day Notice.
The Department of Justice (DOJ), Office of Justice Programs, Bureau of Justice Statistics, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. This notice is being published to seek public comments on a change to the survey instrument proposed for the 2020 collection.
Comments are encouraged and will be accepted for 30 days until October 16, 2019.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Elizabeth Davis, Statistician, Bureau of Justice Statistics, 810 Seventh Street NW, Washington, DC 20531 (email:
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
(1)
(2)
(3)
(4)
(5)
(6)
If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405A, Washington, DC 20530.
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) proposal titled, “Occupational Safety and Health Administration Alliance Program,” to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995. Public comments on the ICR are invited.
The OMB will consider all written comments that agency receives on or before October 16, 2019.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the
Submit comments about this request by mail to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OSHA, Office of Management and Budget, Room 10235, 725 17th Street NW, Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
Frederick Licari by telephone at 202-693-8073, TTY 202-693-8064, (these are not toll-free numbers) or by email at
This ICR seeks PRA authority for the Occupational Safety and Health Administration Alliance Program information collection. OSHA's Alliance Program is a structure for working with groups that are committed to worker safety and health. The program enables OSHA to enter into a voluntary cooperative relationship with industry, labor and other groups to improve workplace safety and health, prevent workplace fatalities, injuries and illnesses, and to reach employers and workers that OSHA may not otherwise reach through traditional methods. OSHA collects information from organizations that are signatories to an Alliance agreement through meetings, informal conversations and data forms. OSHA will use the collected information to develop Alliance agreements, support Alliance activities and Alliance agreement objectives, and develop annual and program-wide reports. Occupational Safety and Health Act of 1970 section (2)(b)(1) authorizes this information collection.
This proposed information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB, under the PRA, approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information if the collection of information does not display a valid Control Number.
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• 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:
• 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;
• Enhance the quality, utility, and clarity of the information to be collected; and
• 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,
44 U.S.C. 3507(a)(1)(D).
Bureau of Labor Statistics (BLS).
Request for nominations to the BLS Technical Advisory Committee.
The BLS is soliciting new members for the Technical Advisory Committee (TAC). Five current membership terms expire on April 12, 2020. The TAC provides advice to the Bureau of Labor Statistics on technical aspects of data collection and the formulation of economic measures and makes recommendations on areas of research. On some technical issues there are differing views, and receiving feedback at public meetings provides BLS with the opportunity to consider all viewpoints. The Committee will consist of 16 members and will be chosen from a cross-section of economists, statisticians, and behavioral scientists who represent a balance of expertise. The economists will have research experience with technical issues related to BLS data and will be familiar with employment and unemployment statistics, price index numbers, compensation measures, productivity measures, occupational and health statistics, or other topics relevant to BLS data series. The statisticians will be familiar with sample design, data analysis, computationally intensive statistical methods, non-sampling errors, or other areas which are relevant to BLS work. The behavioral scientists will be familiar with questionnaire design, usability, or other areas of survey development. BLS invites persons interested in serving on the TAC to submit their names for consideration for committee membership.
Nominations for the TAC membership should be postmarked October 16, 2019.
Nominations for the TAC membership should be sent to: Commissioner William Beach, U.S. Bureau of Labor Statistics, 2 Massachusetts Avenue NE, Room 4040, Washington, DC 20212.
Lucy Eldridge, Associate Commissioner, U.S. Bureau of Labor Statistics, 2 Massachusetts Avenue NE, Office of Productivity and Technology, Room 2150. Washington, DC 20212. Telephone: 202-691-5600. This is not a toll free number. Email:
BLS intends to renew memberships in the TAC for another three years. The Bureau often faces highly technical issues while developing and maintaining the accuracy and relevancy of its data on employment and unemployment, prices, productivity, and compensation and working conditions. These issues range from how to develop new measures to how to make sure that existing measures account for the ever-changing economy. The BLS presents issues and then draws on the specialized expertise of Committee members representing specialized fields within the academic disciplines of economics, statistics and survey design. Committee members are also invited to bring to the attention of BLS issues that have been identified in the academic literature or in their own research.
The TAC was established to provide advice to the Commissioner of Labor Statistics on technical topics selected by the BLS. Responsibilities include, but are not limited to providing comments on papers and presentations developed by BLS research and program staff, conducting research on issues identified by BLS on which an objective technical opinion or recommendation from outside of BLS would be valuable, recommending BLS conduct internal research projects to address technical problems with BLS statistics that have been identified in the academic literature, participating in discussions of areas where the types or coverage of economic statistics could be expanded or improved and areas where statistics are no longer relevant, and establishing working relationships with professional associations with an interest in BLS statistics, such as the American Statistical Association and the American Economic Association.
10:00 a.m., Thursday, September 19, 2019.
Board Room, 7th Floor, Room 7047, 1775 Duke Street (All visitors must use Diagonal Road Entrance) Alexandria, VA 22314-3428.
Open.
1. Share Insurance Fund Quarterly Report.
2. NCUA Rules and Regulations, Supervisory Committee Audits.
3. NCUA Rules and Regulations, Federal Credit Union Bylaws.
4. NCUA Rules and Regulations, Payday Alternative Loans II.
Gerard Poliquin, Secretary of the Board, Telephone: 703-518-6304.
Weeks of September 16, 23, 30, October 7, 14, 21, 2019.
Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public and Closed.
There are no meetings scheduled for the week of September 16, 2019.
There are no meetings scheduled for the week of September 23, 2019.
There are no meetings scheduled for the week of September 30, 2019.
There are no meetings scheduled for the week of October 7, 2019.
There are no meetings scheduled for the week of October 14, 2019.
There are no meetings scheduled for the week of October 21, 2019.
For more information or to verify the status of meetings, contact Denise McGovern at 301-415-0681 or via email at
The NRC Commission Meeting Schedule can be found on the internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings or need this meeting notice or the transcript or other information from the public meetings in another format (
Members of the public may request to receive this information electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555 (301-415-1969), or by email at
The NRC is holding the meetings under the authority of the Government in the Sunshine Act, 5 U.S.C. 552b.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Renewal of existing information collection; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) invites public comment on the renewal of Office of Management and Budget (OMB) approval for an existing collection of information. The information collection is entitled, “NRC Forms 366, 366A, and 366B, Licensee Event Report.”
Submit comments by November 15, 2019. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.
You may submit comments by any of the following methods:
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For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
David Cullison, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email:
Please refer to Docket ID NRC-2019-0085 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
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Please include Docket ID NRC-2019-0085 in the subject line of your comment submission, in order to ensure that the NRC is able to make your comment submission available to the public in this docket.
The NRC cautions you not to include identifying or contact information in comment submissions that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the NRC is requesting public comment on its intention to request the OMB's approval for the information collection summarized below.
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The NRC is seeking comments that address the following questions:
1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility?
2. Is the estimate of the burden of the information collection accurate?
3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?
4. How can the burden of the information collection on respondents be minimized, including the use of automated collection techniques or other forms of information technology?
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Environmental assessment and finding of no significant impact; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is considering the renewal of Special Nuclear Materials (SNM) License SNM-2508 for the Three Mile Island Unit 2 (TMI-2) independent spent fuel storage installation (ISFSI) located on the Idaho National Laboratory (INL) Site, formerly known as the Idaho National Environmental and Engineering Laboratory, in Scoville, Butte County, Idaho. The NRC has prepared an environmental assessment (EA) for this proposed license renewal in accordance with its regulations. Based on the EA, the NRC has concluded that a finding of no significant impact (FONSI) is appropriate, and an environmental impact statement (EIS) is not warranted. The NRC also is conducting a safety evaluation of the proposed license renewal.
The EA and FONSI referenced in this document are available on September 16, 2019.
Please refer to Docket ID NRC-2017-0136 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
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Stacey Imboden, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2462, email:
The NRC is considering a license renewal request for SNM-2508 for the TMI-2 specifically-licensed ISFSI located on the INL site in Butte County, Idaho. The applicant, the U.S. Department of Energy, Idaho Operations Office (DOE-ID), is requesting to renew license SNM-2508 for the TMI-2 ISFSI for an additional 20-year period. The current license was set to expire on March 19, 2019 but, in accordance with section 72.42 (c) of title 10 of the
The NRC staff has prepared a final EA as part of its review of this license renewal request in accordance with the requirements of 10 CFR part 51. Based on the final EA, the NRC has determined that an EIS is not required for this proposed action and a FONSI is appropriate. The NRC is also conducting a safety evaluation of the proposed license amendment pursuant to 10 CFR part 72, and the results will be documented in a separate Safety Evaluation Report (SER). If DOE-ID's request is approved, the NRC will issue the license renewal following publication of this final EA and FONSI and the SER in the
DOE-ID is requesting to renew the TMI-2 specifically-licensed ISFSI license for a 20-year period. The NRC has assessed the potential environmental impacts of the proposed action and the no-action alternative. The results of the NRC's environmental review can be found in the final EA (ADAMS Accession No. ML19122A285). In conducting the environmental review, the NRC considered information in the license renewal application (ADAMS Package Accession No. ML19053A310) and supplemental information submitted by DOE-ID (ADAMS Accession Nos. ML17305A060 and ML17345A156); communications with the Idaho State Historic Preservation Office; the Shoshone-Bannock Tribes; the Idaho field office of the U.S Fish and Wildlife Service; and the Idaho Department of Environmental Quality (IDEQ).
If the license renewal request is approved, DOE-ID would be able to continue to possess and store 29 dry shield canisters (DSCs) that contain 341 canisters of TMI-2 spent fuel core debris at the INL site in accordance with the requirements in 10 CFR part 72 and License SNM-2508 for an additional 20 years. DOE-ID states that no additional material will be added to the ISFSI. The estimated annual dose to the nearest potential member of the public from ISFSI activities is 0.0009 milliSieverts (mSv) [(0.09 millirem (mrem)], which is below the 0.25 mSv/yr (25 mrem/yr) limit specified in 10 CFR 72.104(a) and the 1 mSv/yr (100 mrem/yr) limit in 10 CFR 20.1301(a)(1). Furthermore, DOE-ID maintains a radiation protection program for the ISFSI in accordance with 10 CFR part 20 to ensure that radiation doses are as low as is reasonably achievable (ALARA). Accordingly, no significant radiological or non-radiological impacts are expected to result from approval of the license renewal request, and the proposed action would not significantly contribute to cumulative impacts at the ISFSI site. Additionally, there would be no disproportionately high and adverse impacts on minority and low-income populations.
In its license renewal request, DOE-ID is proposing no changes in how it manages and stores spent fuel at the TMI-2 ISFSI. Approval of the proposed action would not result in any new construction or expansion of the existing ISFSI footprint. No liquid effluents are released due to operation of the ISFSI, and all gaseous effluents from the DSCs are vented through a high-efficiency particulate air filter, resulting in doses sufficiently low that a permit for continuous monitoring is not required. No significant radiological or nonradiological impacts are expected from continued normal operations. Occupational dose estimates associated with the proposed action and continued normal operation and maintenance of the ISFSI are expected to be at ALARA levels and within the limits of 10 CFR 20.1201. Therefore, the NRC staff has determined that pursuant to 10 CFR 51.31, preparation of an EIS is not required for the proposed action, and pursuant to 10 CFR 51.32, a FONSI is appropriate.
Furthermore, the NRC staff determined that this license renewal request does not have the potential to cause effects on historic properties, assuming those were present; therefore, in accordance with 36 CFR 800.3(a)(1), no consultation is required under Section 106 of the National Historic Preservation Act. The NRC staff, however, reached out to and informed the Idaho State Historic Preservation Officer (SHPO) (ADAMS Accession No. ML17144A373) and the Shoshone-Bannock Tribes (ADAMS Accession No. ML17146A117) via letters dated July 6, 2017 of its determination. The SHPO responded on July 27, 2017, that the proposed action would not affect any historic properties (ADAMS Accession No. ML17215A574). The NRC staff also consulted with the U.S. Fish and Wildlife Service in accordance with Section 7 of the Endangered Species Act. The draft EA was sent to the IDEQ for review in January 2019. The IDEQ had no specific comments (ADAMS Accession No. ML19050A174).
Based on its review of the proposed action in the EA, in accordance with the requirements in 10 CFR part 51, the NRC has concluded that the proposed action, renewal of NRC SNM-2508 for the TMI-2 ISFSI located on the INL site in Scoville, Butte County, Idaho, will not significantly affect the quality of the human environment. Therefore, the NRC has determined, pursuant to 10 CFR 51.31 that preparation of an EIS is not required for the proposed action and a FONSI is appropriate.
For the Nuclear Regulatory Commission.
Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94-409, that the Securities and Exchange Commission will hold an Open Meeting on Wednesday, September 18, 2019, at 2:00 p.m., to hear oral argument in an appeal by Alexandre S. Clug, and a cross-appeal by the Division of Enforcement, from an initial decision of an administrative law judge.
Auditorium (L-002) at Commission's headquarters, 100 F Street NE, Washington, DC 20549.
This meeting will be open to the public.
On February 8, 2016, the law judge found that (i) Clug and Aurum Mining, LLC violated Section 17(a) of the Securities Act of 1933 and Section 10(b) of the Securities Exchange Act of 1934 and Rule 10b-5 thereunder by making material misrepresentations and omissions to investors; (ii) PanAm Terra, Inc. violated Securities Act Section 17(a)(2) by making material misrepresentations and omissions to investors; (iii) Clug and The Corsair Group violated Exchange Act Section 15(a)(1) by acting as unregistered brokers; and (iv) Clug aided, abetted, and caused a violation by Michael W. Crow of Exchange Act Section 15(b)(6)(B). The law judge also found that Crow was not a de facto executive officer of PanAm, and therefore that PanAm was not primarily liable or Clug secondarily liable for violating Securities Act Section 17(a), Exchange Act Sections 10(b) and 13(a), and Exchange Act Rules 10b-5, 12b-20, 13a-1, and 13a-13, and that Clug did not violate Exchange Act Rule 13a-14(a) by failing to disclose Crow's role at PanAm in its periodic reports.
The law judge ordered that Clug cease-and-desist from further violations, pay disgorgement plus prejudgment interest, and be barred from the securities industry and from participating in penny stock offerings. The law judge did not sanction Aurum, PanAm, or Corsair.
Clug appealed the law judge's findings of fact and conclusions of law as to his violations and sanctions. The Division cross-appealed the findings related to Crow's role at PanAm and the sanctions for Clug, Aurum, PanAm, and Corsair. The issues likely to be considered at oral argument include whether Clug, Aurum, PanAm, and Corsair committed the above violations and what, if any, sanctions are appropriate.
For further information and to ascertain what, if any, matters have been added, deleted or postponed; please contact Vanessa A. Countryman from the Office of the Secretary at (202) 551-5400.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
Cboe Exchange, Inc. (the “Exchange” or “Cboe Options”) proposes to amend its Rules regarding how complex orders are processed through the Automated Improvement Mechanism (“C-AIM” or “C-AIM Auction”), and move those Rules from the currently effective Rulebook (“current Rulebook”) to the shell structure for the Exchange's Rulebook that will become effective upon the migration of the Exchange's trading platform to the same system used by the Cboe Affiliated Exchanges (as defined below) (“shell Rulebook”). The text of the proposed rule change is provided in Exhibit 5.
The text of the proposed rule change is also available on the Exchange's website (
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.
In 2016, the Exchange's parent company, Cboe Global Markets, Inc. (formerly named CBOE Holdings, Inc.) (“Cboe Global”), which is also the parent company of Cboe C2 Exchange, Inc. (“C2”), acquired Cboe EDGA Exchange, Inc. (“EDGA”), Cboe EDGX Exchange, Inc. (“EDGX” or “EDGX Options”), Cboe BZX Exchange, Inc. (“BZX” or “BZX Options”), and Cboe BYX Exchange, Inc. (“BYX” and, together with Cboe Options, C2, EDGX, EDGA, and BZX, the “Cboe Affiliated Exchanges”). The Cboe Affiliated Exchanges are working to align certain system functionality, retaining only intended differences between the Cboe Affiliated Exchanges, in the context of a technology migration. Cboe Options intends to migrate its trading platform to the same system used by the Cboe Affiliated Exchanges, which the Exchange expects to complete on October 7, 2019. Cboe Options believes offering similar functionality to the
In connection with this technology migration, the Exchange has a shell Rulebook that resides alongside its current Rulebook, which shell Rulebook will contain the Rules that will be in place upon completion of the Cboe Options technology migration. The Exchange proposes to add the provisions of its Rules regarding C-AIM Auctions, as proposed to be modified in this rule filing, to Rule 5.38 in the shell Rulebook.
The proposed rule change moves the provisions regarding AIM Auctions for complex orders from current Interpretations and Policies .07 and .08(b)
The Exchange believes it will provide more clarity to the Rules to have a separate rule regarding how AIM Auctions apply to complex orders (“C-AIM Auctions”), and thus proposes to add Rule 5.38 to the shell Rulebook. As they are today, complex orders will continue to be processed and executed in a C-AIM Auction in a substantially similar manner as simple orders are processed and executed in an AIM Auction pursuant to Rule 5.37 in the shell Rulebook,
The proposed rule change codifies in the proposed introductory paragraph
The proposed rule change deletes the restriction that a solicited order cannot be for the account of any Market-Maker appointed in the class. Current Rule 6.74A, Interpretation and Policy .04, which applies to AIM Auctions of complex orders), imposes this restriction.
The proposed introductory paragraph for Rule 5.38 is the same as the corresponding paragraph for simple AIM (Rule 5.37 in the shell Rulebook), except [sic] introductory paragraph for simple AIM Auctions does not permit the Initiating Order to be comprised of orders for the account of an appointed Market-Maker, and it refers to NBBO rather than SBBO. There is no NBBO for complex orders, as complex orders may be executed without consideration of any prices for the complex strategy that might be available on other exchanges trading the same complex strategy.
Proposed Rule 5.38(a) sets forth eligibility requirements for a C-AIM Auction. Proposed Rule 5.38(a)(5) states the Trading Permit Holder that electronically submits an order into an AIM Auction (the “Initiating TPH”) may not designate an Agency Order or Initiating Order as Post Only. A Post Only complex order is a complex order the System ranks and executes pursuant to Rule 5.33 in the shell Rulebook,
The proposed rule change moves the various other C-AIM Auction eligibility requirements to proposed paragraph (a) and makes nonsubstantive changes:
• The requirement that an Agency Order be in a class of options the Exchange designates as eligible for C-AIM Auctions moves from current Interpretation and Policy .07 to proposed subparagraph (a)(1).
• The requirement that the Initiating TPH mark an Agency Order for AIM processing moves from current subparagraph (b)(1)(A) to proposed subparagraph (a)(2).
• The provision that there is no minimum size for Agency Orders moves from current Interpretation and Policy .03 to proposed subparagraph (a)(3). Additionally, the requirement that the Initiating Order be for the same size as the Agency Order moves from current subparagraphs (a)(2) and (a)(3) to proposed subparagraph (a)(3).
• The provision regarding the minimum increment for the Agency Order and Initiating Order price moves from current subparagraph (a)(3) to proposed subparagraph (a)(4). The proposed rule change makes no changes to the permissible minimum increments for C-AIM Auctions and merely moves it to a new provision in the shell Rulebook.
The proposed rule change also explicitly states that all of the eligibility requirements in proposed paragraph (a) must be met for a C-AIM Auction to be initiated, and that the System rejects or cancels both an Agency Order and Initiating Order submitted to an AIM Auction that do not meet the conditions in proposed paragraph (a).
Proposed Rule 5.38(a) is the same as the corresponding paragraph for simple AIM (Rule 5.37(a)), except the proposed rule change does not provide that an Initiating TPH may not submit an Agency Order if the NBBO is crossed (unless the Agency Order is an AIM ISO or Sweep and AIM). As noted above, there is no NBBO for complex orders, and the legs of complex orders are not subject to the restriction on NBBO trade-throughs. Additionally, the proposed rule change references the opening of the complex order book (“COB”) rather than the market open, as the opening of the COB is when complex orders may begin trading.
Proposed Rule 5.38(b) sets forth the requirements for the stop price of the Agency Order. It states the Initiating Order must stop the entire Agency Order at a price that satisfies the following:
• If the Agency Order is to buy (sell) and (a) the applicable side of the BBO on any component of the complex strategy represents a Priority Customer order on the Simple Book, the stop price must be at least one minimum increment better than the SBB (SBO); or (b) the applicable side of the BBO on each component of the complex strategy represents a non-Priority Customer order or quote on the Simple Book, the stop price must be at or better than the SBB (SBO). This ensures the execution price of the Agency Order will improve the SBBO if there is a Priority Customer order in any of the legs on the Simple Book. The proposed rule change protects Priority Customers in any of the component legs of the Agency Order in the Simple Book. By permitting a Priority Customer Agency Order to trade at the SBBO if there is a resting non-Priority Customer order in the Book, the proposed rule change also protects Priority Customer orders submitted into a C-AIM Auction. The Exchange believes the proposed rule change is consistent with general customer priority principles.
• If the Agency Order is to buy (sell) and a buy (sell) complex order rests on the COB, the stop price must be at least one minimum increment better than the bid (offer) of the resting complex order, unless the Agency Order is a Priority Customer order and the resting order is a non-Priority Customer order, in which case the stop price must be at or better than the bid (offer) of the resting complex order. This ensures the execution price of the Agency Order will improve the price of any resting Priority Customer complex orders on the COB, and that the execution price of a Priority Customer Agency Order will not be inferior to the price of any resting non-Priority Customer complex orders on the COB.
• If the Agency Order is to buy (sell) and (a) the BBO of any component of the complex strategy represents a Priority Customer order on the Simple Book, the stop price must be at least one minimum increment better than the SBO (SBB), or (b) the BBO of each component of the complex strategy represents a non-Priority Customer order on the Simple Book, the stop price must be at or better than the SBO (SBB). This ensures the execution price of the Agency Order will improve the price of the opposite side of the SBBO if there is a Priority Customer order on any leg, and not be through the opposite side of the SBBO. While the stop price may cross the opposite side best-priced complex order resting on the opposite side of the COB, as noted below, any complex interest at a better price than the stop price will trade ahead of the Initiating Order. Pursuant to proposed paragraph (e), any contra-side interest available at better prices than the stop price at the conclusion of a C-AIM Auction will execute against the Agency Order ahead of the Initiating Order. Therefore, the Agency Order will execute at the best prices available at the conclusion of the C-AIM Auction, even if the stop price was inferior to those prices. Simple AIM Auctions may similarly start at prices inferior to the NBBO for the series in certain instances.
• The Initiating TPH must specify (a) a single price at which it seeks to execute the Agency Order against the Initiating Order (a “single-price submission”), including whether it elects to have last priority in allocation (as described below), or (b) an initial stop price and instruction to automatically match the price and size of all C-AIM responses and other trading interest (“auto-match”) up to a designated limit price or at all prices that improve the stop price. The proposed rule change moves this provision from current subparagraph (b)(1)(A) to proposed subparagraph (b)(3). It is also the same as the corresponding simple AIM provision.
Proposed paragraph (c) describes the C-AIM Auction process. Currently, only one C-AIM Auction may be ongoing at any given time in a series, and C-AIM Auctions in the same series may not queue or overlap in any manner.
To the extent there is more than one C-AIM Auction in a complex strategy underway at a time, the C-AIM Auctions conclude sequentially based on the exact time each C-AIM Auction commenced, unless terminated early pursuant to proposed Rule 5.38(d). In the event there are multiple C-AIM Auctions underway that are each terminated early pursuant to proposed paragraph (d), the System processes the C-AIM Auctions sequentially based on the exact time each C-AIM Auction commenced. If the System receives a simple order that causes an AIM and C-AIM (or multiple AIM and/or C-AIM) Auctions to conclude pursuant to proposed Rules 5.37(d) and 5.38(d), the System first processes AIM Auctions (in price-time priority) and then processes C-AIM Auctions (in price-time priority). At the time each C-AIM Auction concludes, the System allocates the Agency Order pursuant to proposed paragraph (e) and takes into account all C-AIM Auction responses and unrelated orders and quotes in place at the exact time of conclusion.
The Exchange believes it is appropriate to permit concurrent C-AIM Auctions in the same complex strategy (for Agency Orders for which the smallest leg is for 50 or more contracts). Different complex strategies are essentially different products, as orders in those strategies cannot interact, just as orders in different series or classes cannot interact. Similarly, while it is possible for a complex order to leg into the Simple Book, a complex order may only execute against simple orders if there is interest in each component in the appropriate ratio for the complex strategy. A simple order in one component of a complex strategy cannot on its own interact with a complex order in that complex strategy. Therefore, the Exchange believes it is appropriate to permit concurrent AIM and C-AIM Auctions that share a component. As proposed, C-AIM Auctions will ensure that Agency Orders execute at prices that protect
The Exchange notes it is currently possible for auctions in a component leg and a complex strategy containing that component (such as a simple AIM Auction in the component and a complex order auction (“COA”) in the complex strategy that contains that component) to occur concurrently, and at the end of each auction, it is possible for interest resting in the Simple Book to trade against the complex order subject to the COA. While these auctions may be occurring at the same time, they will be processed in the order in which they are terminated (similar to how the System will process auctions as proposed above). In other words, suppose today there is an AIM Auction in a series and a COA in a complex strategy for which one of the components is the same series both occurring, which began and will terminate in that order, and each of which last 100 milliseconds. While it is possible for both auctions to terminate nearly simultaneously, the System will still process them in the order in which they terminate. When the AIM Auction terminates, the System will process it in accordance with current Rule 6.74A (Rule 5.37 in the shell Rulebook), and the auctioned order may trade against any resting interest (in addition to the contra-side order and responses submitted to that AIM Auction, which may only trade against the order auctioned in that AIM current Rule 6.74A (Rule 5.37 in the shell Rulebook)). The System will then process the COA Auction when it terminates, and the auctioned order may trade against any resting interest, including any simple interest that did not execute against the AIM order (in addition to the contra-side order and responses submitted to that COA Auction, which may only trade against the order auctioned in that COA), pursuant to current Rule 6.53C.
The proposed rule change moves and makes nonsubstantive changes to other provisions regarding the C-AIM Auction process to proposed paragraph (c):
• The proposed rule change moves the provision regarding the C-AIM Auction notification message (currently called a request for responses (“RFR”)) from current subparagraph (b)(1)(B) to proposed subparagraph (c)(2). The proposed provision specifies that the message will detail the side, size, Auction ID, and complex strategy of the Agency Order to all Users that elect to receive C-AIM Auction notification messages. This is consistent with the current RFR that is disseminated. The current rule states that the RFR states the side and size of the Agency Order; the proposed rule change adds details regarding other information that is included in the notification messages. The Exchange believes not certain information about the Agency Order (such as the stop price and Capacity) encourages market participants to submit responses with their best possible prices, which may result in more price improvement for the Agency Order. The proposed rule change also adds that C-AIM Auction notification messages are not included in OPRA, which is also consistent with current functionality.
• The proposed rule change moves the provision regarding the length of the C-AIM Auction period from current subparagraph (b)(1)(C) to proposed subparagraph (c)(3). The proposed rule change makes no changes to the current range of permitted lengths of C-AIM Auction periods.
• The proposed rule change moves the provision that prohibits an Initiating TPH from modifying or cancelling an Agency Order or Initiating Order after submission to a C-AIM Auction from current subparagraph (b)(1)(A) to proposed subparagraph (c)(4).
The proposed rule change also moves all provisions regarding C-AIM Auction responses into proposed subparagraph (c)(5), as well as makes certain changes described below, as well as nonsubstantive changes:
• The proposed rule change moves the provision regarding which market participants may respond to C-AIM Auctions from current subparagraphs (b)(1)(D) and (E) to proposed subparagraph (c)(5). Currently, only Market-Makers with an appointment in the applicable class and Trading Permit Holder (“TPHs”) representing orders as agent at the top of the Book may respond to C-AIM Auctions.
• The proposed rule change moves provisions regarding what must be specified in the responses (including price, size, side, and Auction ID) from current subparagraphs (b)(1)(D) and (E) to proposed subparagraph (c)(5).
• The current rule specifies that responses must specify prices and sizes; the proposed rule change adds responses must also specify side and an Auction ID. The proposed rule change adds that a C-AIM response may only participate in the C-AIM Auction with the Auction ID specified in the response. This is consistent with current functionality.
• The proposed rule change moves the provision regarding the permissible minimum increment for C-AIM responses from current subparagraph (b)(1)(G) to proposed subparagraph (c)(5)(A), but makes no substantive changes.
• Proposed subparagraph (c)(5)(B) states that C-AIM buy (sell) responses are capped at the following prices that exist at the conclusion of the C-AIM Auction: (i) the better of the SBO (SBB)
• Proposed subparagraph (c)(5)(C) states a User may submit multiple C-AIM responses at the same or multiple prices to a C-AIM Auction. This is consistent with current functionality. Current Rule 6.74A contains no restriction on how many responses a User may submit; the proposed rule change merely makes this explicit in the Rules. The proposed rule change also states for purposes of a C-AIM Auction, the System aggregates all of a User's complex orders on the COB and C-AIM responses for the same EFID at the same price. This (combined with the proposed size cap) will prevent a User from submitting multiple orders or responses at the same price to obtain a larger pro-rata share of the Agency Order.
• Proposed subparagraph (c)(5)(D) states the System caps the size of a C-AIM response, or the aggregate size of a User's complex orders on the COB and C-AIM responses for the same EFID at the same price, at the size of the Agency Order (
• Proposed subparagraph (c)(5)(E) states C-AIM responses must be on the opposite side of the market as the Agency Order, and the System rejects an AIM response on the same side of the market as the Agency Order. This is consistent with current functionality, and the proposed rule change merely adds this detail to the rules. Additionally, the Exchange believes this is reasonable given that the purpose of a C-AIM response is to trade against the Agency Order in the C-AIM Auction into which the C-AIM response was submitted.
• Proposed subparagraph (c)(5)(F) states C-AIM responses may be designated with the match trade prevention (“MTP”) modifier of MTP Cancel Newest, but no other MTP modifiers, and the System rejects a C-AIM response with any other MTP modifier.
• Proposed subparagraph (c)(5)(G) states C-AIM responses may not be designated as immediate-or-cancel (“IOC”) and the System rejects a C-AIM response designated as IOC.
• The provision that states C-AIM responses are not visible to C-AIM Auction participants or disseminated to OPRA moves from current subparagraph (b)(1)(F) to proposed subparagraph (c)(5)(H).
• The provision that states C-AIM responses may be cancelled moves from current subparagraph (b)(1)(I) to proposed subparagraph (c)(5)(I). The proposed rule change also clarifies that C-AIM responses may be modified (which is consistent with current functionality and merely clarified in the rules).
Pursuant to proposed Rule 5.38(d), a C-AIM Auction concludes at the earliest to occur of the following times:
• The end of the C-AIM Auction period;
• upon receipt by the System of an unrelated non-Priority Customer complex order on the same side as the Agency Order that would post to the COB at a price better than the stop price;
• upon receipt by the System of an unrelated Priority Customer complex order on the same side as the Agency Order that would post to the COB at a price equal to or better than the stop price;
• upon receipt by the System of an unrelated non-Priority Customer order or quote that would post to the Simple Book and cause the SBBO on the same side as the Agency Order to be better than the stop price;
• upon receipt by the System of a Priority Customer order in any
• upon receipt by the System of a simple non-Priority Customer order that would cause the SBBO on the opposite side of the Agency Order to be better than the stop price, or a Priority Customer order that would cause the SBBO on the opposite side of the Agency Order to be equal to or better than the stop price;
• upon receipt by the System of an order that would case the SBBO to be a price not permissible under the Limit Up-Limit Down Plan or Regulation SHO, provided, however, that in such instance, the C-AIM Auction concludes without execution;
• the market close; and
• any time the Exchange halts trading in the complex strategy or any component of the complex strategy, provided, however, that in such instance, the C-AIM Auction concludes without execution.
The Exchange proposes to conclude the C-AIM Auction in response to the incoming orders described above, as they would cause the SBBO or the best-priced complex order on the same side of the market as the Agency Order to be better priced than the stop price, or cause the stop price to be the same price as the SBBO with a Priority Customer order on the BBO for a component or a Priority Customer complex order on the COB. Similarly, the incoming orders described above would cause the opposite side SBBO to be at or better than the stop price. These events would create circumstances under which a C-AIM Auction would not have been initiated, and therefore, the Exchange believes it is appropriate to conclude a C-AIM Auction when they exist.
Additionally, the proposed rule change would conclude a C-AIM Auction in response to an incoming order that would cause the SBBO to be at a price not permissible under the Limit Up-Limit Down Plan or Regulation SHO,
Proposed Rule 5.38(d)(2) states if the System receives an unrelated market or marketable limit complex order (against the SBBO or the best price of a complex order resting in the COB), including a Post Only complex order, on the opposite side of the market during a C-AIM Auction, the C-AIM Auction does not end early, and the System executes the order against interest outside the C-AIM Auction or posts the complex order to the COB. If contracts remain from the unrelated complex order at the time the C-AIM Auction ends, they may be allocated for execution against the Agency Order pursuant to proposed Rule 5.38(e). Because these orders may have the opportunity to trade against the Agency Order following the conclusion of the C-AIM Auction, which execution must still be at or better than the SBBO and the best-priced complex orders on the COB, the Exchange does not believe it is necessary to cause a C-AIM Auction to conclude early in the event the Exchange receives such orders. This will provide more time for potential price improvement, and the unrelated complex order will have the opportunity to trade against the Agency Order in the same manner as all other contra-side interest.
At the conclusion of a C-AIM Auction, the System executes the Agency Order against the Initiating Order or contra-side complex interest in the same manner as it does today (and similar to the manner in which it executes a simple Agency Order).
Unlike today, the Agency Order will only execute against the Initiating Order, C-AIM responses, and complex orders resting in the COB, and will not leg into the Simple Book, at the conclusion of a C-AIM Auction. As proposed, the execution prices for an Agency Order will always be better than the SBBO existing at the conclusion of the C-AIM Auction if it includes a Priority Customer order on any leg, and thus is consistent with general customer priority principles with respect to complex orders, pursuant to which complex orders may only trade against complex interest at prices that improve the BBO of any component that is represented by a Priority Customer order.
The Simple Book and the COB are separate, and orders on each do not interact unless a complex order legs into the Simple Book. As a result, the System is not able to calculate the aggregate size of complex auction responses and complex orders on the COB and the size of simple orders in the legs that comprise the complex strategy at each potential execution price (as executions may occur at multiple prices) prior to execution of an order following an auction for complex orders. The current priority following a C-AIM Auction provides that the System will first execute the complex order against all interest in the Simple Book, and then against interest in the COB.
The amount of aggregate interest available to execute against the Agency Order is relevant in a C-AIM Auction with respect to the allocation of contracts against the Agency Order and other interest at each price level, and with respect to determining the final price level at which the Agency Order will execute. For example, when auto-match is selected, because the System will not be able to determine the aggregate size of contra-side interest (including simple and complex) at that price level, it would not be able to determine how many contracts of the Agency Order should execute against the Initiating Order (which should equal the aggregate size of that contra-side interest). Additionally, because the System will not be able to determine the aggregate size of contra-side interest (including simple and complex) at the stop price, it would not be able to determine the applicable percentage of the Agency Order that should execute against the Initiating Order.
The Exchange notes there would be significant technical complexities associated with reprogramming priority within the System to permit Agency Orders to leg into the Simple Book following a C-AIM Auction and allocate the Agency Order in a manner consistent with standard priority principles and crossing auctions, while making the most crossing functionality available to TPHs. The proposed rule change will ensure the Agency Order executes in accordance with the C-AIM allocation principles (which are consistent with AIM allocation principles), which provide Priority Customers with priority over the Initiating Order (and other contra-side interest) but also provide for the Initiating Order to execute against a certain portion of the Agency Order, as well as provide Initiating TPHs with flexibility to submit single-price submissions or auto-match at multiple price levels. The Exchange believes providing this functionality will encourage TPHs to submit complex orders into C-AIM Auctions and provide customer orders with opportunities for price improvement. It will also ensure orders (including Priority Customer orders) on the Simple Book are protected in accordance with standard complex order priority principles, as an Agency Order will only be permitted to execute at prices that do not trade at the SBBO existing at the conclusion of the C-AIM Auction if it includes a Priority Customer order on any leg, and that do not trade through the SBBO existing at the conclusion of the C-AIM Auction.
As noted above, the stop price of the Agency Order must be better than the same and opposite side of the SBBO if there is a Priority Customer order at the BBO in any component of the complex strategy. Additionally, the stop price must be better than the price of any Priority Customer order resting at the top of the COB on the same side as the Agency Order. Further, a C-AIM Auction will conclude upon receipt of an unrelated Priority Customer order in any component of the complex strategy that would post to the Simple Book and cause the SBBO on either side of the Agency Order to be equal to or better than the stop price, or upon the receipt of an unrelated Priority Customer complex order on the same side as the Agency Order that post to the COB with a price equal to or better than the stop price. Additionally, any execution prices at the conclusion of the C-AIM Auction will be subject to the standard complex order priority rules in Rule 5.33 in the shell Rulebook,
Proposed Rule 5.38(f) regarding Customer-to-Customer C-AIM Immediate crosses is consistent with current functionality, and merely adds detail regarding the current price restrictions applicable to these executions.
Proposed Rule 5.38, Interpretations and Policies .01 through .03 are the same as current Rule 6.74A, Interpretations and Policies .01, .02, and .08, which currently apply to AIM Auctions for complex orders.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The proposed rule change is generally intended to align certain system functionality currently offered by Cboe Options to the Exchange's System in order to provide a consistent technology offering for the Cboe Affiliated Exchanges. A consistent technology offering, in turn, will simplify the technology implementation, changes and maintenance by Users of the Exchange that are also participants on Cboe Affiliated Exchanges. This will provide Users with greater harmonization of price improvement auction mechanisms available among the Cboe Affiliated Exchanges.
The Exchange's C-AIM will function in a substantially similar manner following the technology migration as it does today. The proposed rule change clarifies in the Rules that the Initiating Order may be comprised of multiple contra-party orders will benefit investors. As noted above, this is consistent with current functionality, and the proposed rule change merely adds this detail to the rule, which additional transparency will benefit investors. Permitting the Initiating Order to be comprised of multiple contra-party orders may increase the opportunity for customers to have orders participate in a C-AIM auction. As a result, this may increase opportunities for price improvement, because this will increase the liquidity available for the Initiating Order, which is consistent with the purpose of C-AIM Auctions. The Exchange believes that this is beneficial to participants because allowing multiple contra-parties should foster competition for filling the Initiating Order and thereby result in potentially better prices, as opposed to only allowing one contra-party and, thereby requiring that contra-party to do a larger size order which could result in a worse price for the trade.
The proposed rule change to prohibit Initiating TPHs from designating an Agency Order or Initiating Order as Post Only is appropriate, as the purpose of a Post Only order is to not execute upon entry and instead rest in the Book, while the purpose of a C-AIM Auction is to receive an execution following the Auction but prior to entering the Book.
The proposed rule change to require the stop price to be at least one minimum increment better than the best-priced complex order in the COB, unless the Agency Order is a Priority Customer order and the resting order is not a Priority Customer, in which case the stop price must be at or better than the price of the complex order will protect investors. It will protect Priority Customer orders on the same side of the COB, as the current rule does, except it does so by applying a check at the initiation of a C-AIM Auction rather than at the conclusion of the Auction. By permitting a Priority Customer Agency Order to trade at the same price as a resting non-Priority Customer order, the proposed rule change also protects Priority Customer orders submitted into a C-AIM Auction. Additionally, application of this check at the initiation of a C-AIM Auction may result in the Agency Order executing at a better price, since the stop price must improve any same-side orders (with the exception of a Priority Customer Agency Order and a resting non-Priority Customer order described above), as under the current Rule, the Agency Order may execute at one minimum increment worse. The proposed rule change is consistent with general customer priority principles.
As noted above, the proposed rule change will allow C-AIM Auctions for which the smallest leg is for 50 standard option contracts (or 500 mini-option contracts) or more to occur concurrently with other C-AIM Auctions. Although C-AIM Auctions for larger Agency Orders will be allowed to overlap, the Exchange does not believe that this raises any issues that are not addressed by the proposed rule change. For example, although overlapping, each C-AIM Auction will be started in a sequence and with a time that will determine its processing. Thus, even if there are two C-AIM Auctions that commence and conclude, at nearly the same time, each C-AIM Auction will have a distinct conclusion at which time the Auction will be allocated. In turn, when the first C-AIM Auction concludes, unrelated orders that then exist will be considered for participation in the Auction. If unrelated orders are fully executed in such C-AIM Auction, then there will be no unrelated orders for consideration when the subsequent Auction is processed (unless new unrelated order interest has arrived). If instead there is remaining unrelated order interest after the first C-AIM Auction has been allocated, then such unrelated order interest will be considered for allocation when the subsequent Auction is processed. As another example, each C-AIM response is required to specifically identify the Auction for which it is targeted and if not fully executed will be cancelled back at the conclusion of the Auction. Thus, C-AIM responses will be specifically considered only in the specified Auction.
The proposed rule change to allow multiple auctions to overlap for Agency Orders of 50 standard option contracts (or 500 mini-option contracts) or more is consistent with functionality already in place on other exchanges.
The proposed rule change to permit all Users to respond to C-AIM Auctions will benefit investors. Permitting all Users to submit responses to C-AIM Auctions, rather than appointed Market-Makers and TPHs representing orders as agent at the top of the Book or COB, may result in more Users having the opportunity to participate in executions at the conclusion of C-AIM Auctions. Additionally, it may increase liquidity in C-AIM Auctions, which may lead to more opportunities to [sic] price improvement. The Exchange believes the proposed rule change will remove impediments to and perfect the mechanism of a free and open market and a national market system, because other exchanges permit all market participants to respond to similar price improvement auctions.
The proposed rule changes regarding permissible designations on responses are reasonable and promote a fair and orderly market, because they are consistent with the general auction functionality. The proposed rule change that prohibits Users from designating a C-AIM Auction response with an MTP Modifier other than MTP Cancel Newest is consistent with the prohibition on the Agency Order being cancelled after it is submitted. Additionally, the proposed rule change that prohibits Users from designating a response as IOC is reasonable, because it consistent with the purpose of an AIM response, which is to potentially execute against an Agency Order at the conclusion of a C-AIM Auction (and thus not immediately upon entry, as required by the time-in-force of IOC).
The proposed events that will conclude a C-AIM Auction are reasonable and promote a fair and orderly market and national market system, because they will ensure that executions at the conclusion of an Auction occur at permissible prices (such as not outside the SBBO (and not at the SBBO if there is a Priority Customer order in any component on the Simple Book) and not at the same price as a Priority Customer order on the COB). The proposed rule change will also benefit investors by providing clarity regarding what will cause a C-AIM Auction to conclude. These events would create circumstances under which a C-AIM Auction would not have been permitted to start, or that would cause the auction price no longer be consistent with the permissible prices at which executions at the conclusion of an Auction may occur. Thus the Exchange believes it is appropriate to conclude a C-AIM Auction if those circumstances occur. The Exchange will no longer conclude a C-AIM Auction early due to the receipt of an opposite side complex order other than one proposed instance. The Exchange believes this promotes just and equitable principles of trade, because these orders may have the opportunity to trade against the Agency Order following the conclusion of the Auction, which execution must still be at or better than the SBBO, as well as prices of complex orders in the COB. The Exchange believes this will protect investors, because it will provide more time for price improvement, and the unrelated order will have the opportunity to trade against the Agency Order in the same manner as all other contra-side complex interest.
The Exchange believes the proposed execution of Agency Orders are reasonable and promote a fair and orderly market and national market system, because best-priced contra-side interest executes against the Agency Order first, and Priority Customer complex orders will have first priority at each price level, followed by other contra-side complex interest. The proposed rule change does not adopt Priority Order status for C-AIM, which is only available in simple AIM for classes the Exchange designates.
In a separate rule filing, the Exchange intends to adopt complex order allocation rules consistent with those in EDGX Options Rule 21.20 as part of its efforts harmonize rules and functionality across the Cboe Affiliated Exchanges. Pursuant to that rule, if an order is able to leg into the Simple Book, the System would first execute an order against Priority Customer orders in the Simple Book, then against any complex order interest in the COB (or auction responses), and last against any other simple interest in the Simple Book (with executions against the Simple Book occurring in the applicable ratio). This would occur at each price at which the complex order may execute. Requiring the System to make these determinations by going “back and forth” between the Simple Book and the COB at multiple price levels would be more complicated after a C-AIM Auction. The System must determine the aggregate amount of interest available at each execution price level before executing any portion of the Agency Order to determine the final auction price and how to allocate the Agency Order against contra-side interest at the conclusion of a C-AIM Auction. This is necessary because the System must determine at each price level the aggregate non-Priority Customer interest to calculate any auto-match amounts, and to determine the aggregate number of contracts remaining in the Agency Order at the final auction price to calculate the allocation percentage for the Initiating Order.
There would be significant technical complexities associated with reprogramming priority within the System to permit Agency Orders to leg into the Simple Book following a C-AIM Auction and allocate the Agency Order in a manner consistent with standard priority principles and crossing auctions, while making the most crossing functionality available to TPHs. As discussed above, the Exchange believes the proposed rule change protects Priority Customer orders on the Simple Book, because executions following a C-AIM Auction are subject to the general complex order priority
Given the infrequency with which complex orders currently leg into the Simple Book, including at the conclusion of C-AIM Auctions for complex orders, the Exchange believes it is in the best interest of investors to not implement additional technical complexities given the expected minimal impact, if any, that not permitting Agency Orders to leg into the Simple Book following a C-AIM Auction would have on execution opportunities for orders in the Simple Book.
The Exchange believes the proposed rule changes that add detail to the Rules, which are consistent with current functionality, will remove impediments to and perfect the mechanism of a free and open market and protect investors, as these changes provide transparency in the Rules regarding C-AIM Auctions. Additionally, the proposed rule change aligns rule language with corresponding provisions in EDGX Options Rule 21.22.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe the proposed rule change to amend the C-AIM Auction will impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act, as the proposed changes to the C-AIM Auction will apply to all orders submitted to an Auction in the same manner. C-AIM Auctions will continue to be voluntary for TPHs to use, and are available to all TPHs. The Exchange does not believe the proposed rule change will impose any burden on intermarket competition that is not necessary or appropriate in furtherance of the purposes of the Act, because the proposed changes are substantially the same as another options exchange's rules.
The Exchange does not believe the proposed rule change to permit all Users to respond to C-AIM Auctions will impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act, because it will permits more types of market participants (
The Exchange neither solicited nor received comments on the proposed rule change.
Because the foregoing proposed rule change does not:
A. Significantly affect the protection of investors or the public interest;
B. impose any significant burden on competition; and
C. become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
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:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
In notice document 2019-18999 beginning on page 46588 in the issue of Wednesday, September 4, 2019, make the following correction:
On page 46593, in the third column, in the first paragraph, starting in the two last lines “September 24, 2019” should read “September 25, 2019”.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Regulation S-AM implements the requirements of Section 624 of the FCRA (15 U.S.C. 1681s-3) with respect to investment advisers and transfer agents registered with the Commission, as well as brokers, dealers and investment companies (collectively, “Covered Persons”). Section 624 and Regulation S-AM limit a Covered Person's use of certain consumer financial information received from an affiliate to solicit a consumer for marketing purposes, unless the consumer has been given notice and a reasonable opportunity and a reasonable and simple method to opt out of such solicitations. Regulation S-AM potentially applies to all of the approximately 20,195 Covered Persons registered with the Commission, although only approximately 11,309 of them have one or more corporate affiliates, and the regulation requires only approximately 2,020 to provide consumers with an affiliate marketing notice and an opt-out opportunity.
The Commission staff estimates that there are approximately 11,309 Covered Persons having one or more affiliates, and that they each spend an average of 0.20 hours per year to review affiliate marketing practices, for, collectively, an estimated annual time burden of 2,262 hours at an annual internal compliance cost of approximately $1,203,384. The staff also estimates that approximately 2,020 Covered Persons provide notice and opt-out opportunities to consumers, and that they each spend an average of 7.6 hours per year creating notices, providing notices and opt-out opportunities, monitoring the opt-out notice process, making and updating records of opt-out elections, and addressing consumer questions and concerns about opt-out notices, for, collectively, an estimated annual time burden of 15,352 hours at an annual internal compliance cost of approximately $2,999,296. Thus, the staff estimates that the collection of information requires a total of approximately 11,309 respondents to incur an estimated annual time burden of a total of 17,614 hours at a total annual internal cost of compliance of approximately $4,202,680.
Written comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's estimates of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
Please direct your written comments to: Charles Riddle, Acting Director/Chief Information Officer, Securities and Exchange Commission, c/o Candace Kenner, 100 F Street NE, Washington, DC 20549, or send an email to:
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
Cboe Exchange, Inc. (the “Exchange” or “Cboe Options”) proposes to amend the Exchange's Rules regarding price protections and risk controls, and moves those Rules from the currently effective Rulebook (“current Rulebook”) to the shell structure for the Exchange's Rulebook that will become effective upon the migration of the Exchange's trading platform to the same system
The text of the proposed rule change is also available on the Exchange's website (
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.
In 2016, the Exchange's parent company, Cboe Global Markets, Inc. (formerly named CBOE Holdings, Inc.) (“Cboe Global”), which is also the parent company of Cboe C2 Exchange, Inc. (“C2”), acquired Cboe EDGA Exchange, Inc. (“EDGA”), Cboe EDGX Exchange, Inc. (“EDGX” or “EDGX Options”), Cboe BZX Exchange, Inc. (“BZX” or “BZX Options”), and Cboe BYX Exchange, Inc. (“BYX” and, together with Cboe Options, C2, EDGX, EDGA, and BZX, the “Cboe Affiliated Exchanges”). The Cboe Affiliated Exchanges are working to align certain system functionality, retaining only intended differences between the Cboe Affiliated Exchanges, in the context of a technology migration. Cboe Options intends to migrate its trading platform to the same system used by the Cboe Affiliated Exchanges, which the Exchange expects to complete on October 7, 2019. In connection with this technology migration, the Exchange has a shell Rulebook that resides alongside its current Rulebook, which shell Rulebook will contain the Rules that will be in place upon completion of the Cboe Options technology migration.
The Exchange proposes to harmonize its rules in connection with the risk control and price protection functions on the Exchange to that of its affiliated Exchanges. Specifically, the Exchange proposes to consolidate all order and quote price protection mechanisms and risk controls into a single rule, proposed Rule 5.34 (and subsequently delete the relevant price protection mechanism and risk control provisions in current Rules 6.12, 6.13, 6.14, 6.23C, and 6.53C.08 upon migration). Proposed Rule 5.34 is substantively identical to C2 Rule 6.14, as well as substantially the same as corresponding EDGX Options Rules 21.16, 21.17 and 22.11. In line with C2 Rule 6.14, proposed Rule 5.34 categorizes these mechanisms and controls as ones applicable to simple orders (proposed paragraph (a)), complex orders (proposed paragraph (b)), and all (
The price
The proposed rule change also deletes the mechanisms related to execution of quotes that lock or cross the NBBO and quotes inverting the NBBO (current Rule 6.14(b) and (c)). The Exchange's current quote functionality will be replaced with bulk message functionality
Under the current C2 and EDGX debit/credit price reasonability check (see C2 Rule 6.14(b)(3) and EDGX Rule 21.17(b)(3)), the System only pairs calls (puts) if they have the same expiration date but different exercise prices or the same exercise price but different expiration dates. Under the Exchange's
The proposed Risk Monitor Mechanism is identical to the current functionality on C2 and substantively the same as the functionality currently available on EDGX. Because there will no longer be separate order and quote functionality on the Exchange following the technology migration, there will no longer be separate mechanisms to monitor entry and execution rates, as there are on the Exchange today. Each User may establish limits for the following parameters in the Exchange's counting program. The System counts each of the following within a class (“class limit”)
(i) Number of contracts executed (“volume”);
(ii) notional value of executions (“notional”);
(iii) number of executions (“count”);
(iv) number of contracts executed as a percentage of number of contracts outstanding within an Exchange-designated time period or during the trading day, as applicable (“percentage”), which the System determines by calculating the percentage of a User's outstanding contracts that executed on each side of the market during the time period or trading day, as applicable, and then summing the series percentages on each side in the class; and
(v) number of times the limits established by the parameters under the above-listed are reached (“risk trips”).
Also, when the System determines the volume, notional, count, percentage, or risk trips limits have been reached:
(i) a User's class limit within the interval or the absolute limit for the class, the Risk Monitor Mechanism cancels or rejects such User's orders or quotes in all series of the class and cancels or rejects any additional orders or quotes from the User in the class until the counting program resets (as described below).
(ii) a User's firm limit within the interval or the absolute limit for the firm, the Risk Monitor Mechanism cancels or rejects such User's orders or quotes in all classes and cancels or rejects any additional orders or quotes from the User in all classes until the counting program resets (as described below).
(iii) a User's EFID Group limit within the interval or the absolute limit for the EFID Group, the Risk Monitor Mechanism cancels or rejects such User's orders or quotes in all classes and cancels or rejects any additional orders or quotes from any EFID within the EFID Group in all classes until the counting program resets (as described below).
The Risk Monitor Mechanism will also attempt to cancel or reject any orders routed away to other exchanges. The System processes messages in the order in which they are received. Therefore, it will execute any marketable orders or quotes that are executable against a User's order or quote and received by the System prior to the time the Risk Monitor Mechanism is triggered at the price up to the size of the User's order or quote, even if such execution results in executions in excess of the User's parameters. The System will not accept new orders or quotes from a User after a class limit is reached until the User submits an electronic instruction to the System to reset the counting program for the class. The System will not accept new orders or quotes from a User after an EFID limit or EFID Group limit is reached until the User manually notifies the Trade Desk to reset the counting program for the firm, unless the User instructs the Exchange to permit it to reset the counting program by submitting an electronic message to the System. The Exchange may restrict the number of User class and firm resets per second. The System counts executed COA responses as part of the Risk Monitor Mechanism. The System counts individual trades executed as part of a complex order when determining whether the volume, notional, count, or risk trips limit has been reached. The System counts the percentage executed of a complex order when determining whether the percentage limit has been reached. In addition, a User may also engage the Risk Monitor Mechanism to cancel resting bids and offers, as well as order set forth in the kill switch protection provision. The Risk Monitor Mechanism providers Users with similar ability to manage their order and execution risk to the quote risk monitor and rate checks currently available on the Exchange, and merely uses different parameters and modifies the functionality to conform the new System to that of C2 and EDGX upon migration.
With respect to various price protections and risk controls in current Rules 6.12.01, 6.13, and 6.53C.08, the Exchange has the authority to provide intraday relief by widening or inactivating one or more of the parameter settings for the mechanisms in those rules. This authority is included in proposed Interpretation and Policy .01, to provide this flexibility for all price protections and risk controls for which the Exchange sets parameters, providing the Exchange with flexibility it believes appropriate given previous experience with risk controls. This is consistent with corresponding C2 Rule 6.14.01. The Exchange will continue to make and keep records to document all determinations to grant intraday relief, and periodically review these determinations for consistency with the interest of a fair and orderly market.
The proposed rule change makes a non-substantive change in moving the provision regarding the Exchange's ability to share User-designated risk settings in the System with a Clearing Trading Permit Holder that clears Exchange transactions on behalf of the User from the introduction of current Rule 6.14 to proposed Rule 5.34.02. Also, the proposed change makes non-substantive changes in that it updates all provisions to account for “User” as opposed to Trading Permit Holder (“TPH”), which is consistent with the definition under Rule 1.1 the shell Rulebook, and the use of the term throughout the Exchange Rules upon migration.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations
The proposed rule change is generally intended to add or align certain System functionality in connection with price protection mechanisms and risk controls with functionality currently offered by C2 and EDGX in order to provide a consistent technology offering for the Cboe Affiliated Exchanges. A consistent technology offering, in turn, will simplify the technology implementation, changes and maintenance by Users of the Exchange that are also participants on Cboe Affiliated Exchanges. The proposed rule changes would also provide Users with access to functionality that is generally available on markets other than the Cboe Affiliated Exchanges and may result in the efficient execution of such orders and will provide additional flexibility as well as increased functionality to the Exchange's System and its Users. The proposed rule change seeks to provide greater harmonization between the rules of the Cboe Affiliated Exchanges, which would result in greater uniformity and less burdensome and more efficient regulatory compliance. As such, the proposed rule change would foster cooperation and coordination with persons engaged in facilitating transactions in securities and would remove impediments to and perfect the mechanism of a free and open market and a national market system. The Exchange also believes that consistent rules will increase the understanding of the Exchange's operations for Trading Permit Holders that are also participants on the Cboe Affiliated Exchanges, thereby contributing to the protection of investors and the public interest. The proposed rule change does not propose to implement new or unique functionality that has not been previously filed with the Commission or is not available on Cboe Affiliated Exchanges. The Exchange notes that the proposed rule text mirrors C2 Rules, save for intended differences that account for PAR (unique to the Exchange), Exchange-specific cross-references and references to certain terms (
Overall, the Exchange believes the additional and enhanced price protection mechanisms and risk controls will protect investors and the public interest and maintain fair and orderly markets by mitigating potential risks associated with market participants entering orders and quotes at unintended prices, and risks associated with orders and quotes trading at prices that are extreme and potentially erroneous, which may likely have resulted from human or operational error. The Exchange notes that the proposed rule change is substantially similar to the current Cboe Options Rules, and, while the Exchange currently offers many similar protections and controls, as described above, the Exchange believes Users will benefit from the additional functionality that will be available following the technology migration.
As indicated in the table above, the proposed price protection and risk control mechanisms no longer establish outer boundaries or limits to the levels at which mechanisms are set (save for the proposed no-bid provision, noted below), but instead, the proposed rule change amends the price protection mechanisms and risk controls to account for Exchange-determined and/or User-determined buffer or default amounts. The Exchange believes this removes impediments to and perfects the mechanism of a free and open market and national market system because it affords the Exchange and Users reasonable and necessary flexibility to establish and modify the default parameters, which, in turn, protects investors and the public interest, and maintains a fair and orderly market. The Exchange notes any Exchange-determined parameters will always be available on the Exchange's website via specification or Notice.
The proposed drill-through protections for complex orders removes impediments to and perfect the mechanism of a free and open market and national market system and facilitates transactions in securities by adding detail to the rules regarding complex order price protections. Particularly, by adding that a COA-eligible order would initiate a COA at the drill-through price because the prices for complex strategy executions may be subject to the drill-through protection and permitting an order that is not currently executable due to Legging restrictions to remain on the COB if the SBBO changes during the set time-period will provide additional execution opportunities, for Users' orders participating in the COA and/or prior to cancellation.
The proposed provision in connection with the Risk Monitor Mechanism will not alter the function of this mechanism for market participants as it provides Users with the ability to manage their order and execution risk to the quote risk monitor and rate checks similar to that which is currently available on the Exchange, and merely uses different parameters and modifies the functionality to conform the new System to that of C2 and EDGX upon migration. The Exchange also notes that this functionality is optional; it is User-enabled and the parameters are User-established.
The proposed rule change also removes functionality, and reference to such functionality, that will not exist upon migration in order to align the Exchange's System with that of its affiliated options exchanges, which will serve to remove impediments to and perfect the mechanism of a free and open market and national market system by providing market participants with rules that accurately reflect functionality post-migration and effectively harmonize Exchange functionality with that of C2 and EDGX. Moreover, the Exchange does not believe that the proposed change that removes functionality that will no longer be available upon migration will impact investors because the proposed change provides substantially similar alternative mechanisms and controls that result in the same protections as current Exchange functionality. The
As stated, the Exchange notes the proposed price protection mechanisms and risk controls provisions do not present any new or unique rules or functionality for market participants as the proposed rule is substantially similar to the Exchange's current rules, identical to C2 Rule 6.14, as well as substantively the same as corresponding EDGX rules and technical specifications, as discussed above. The proposed rule change makes various non-substantive changes throughout the rules by updating cross-references and Exchange-specific terms, and by means of conforming language to C2 Rule 6.14, as well as corresponding EDGX rules, that will protect investors and benefit market participants as these changes simplify or clarify rules, delete duplicative rule provisions, conform paragraph numbering and lettering throughout the rules, and use plain English.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange reiterates that the proposed rule change is being proposed in the context of the technology integration of the Cboe Affiliated Exchanges. Thus, the Exchange believes this proposed rule change is necessary to permit fair competition among national securities exchanges.
The Exchange does not believe that the proposed rule change will impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act. Rather, the proposed rule change is designed to benefit Exchange participants in that it will provide a consistent technology offering for Users by the Cboe Affiliated Exchanges. Following the technology migration, the Exchange's System, as described in this proposed rule change, will apply to all Users and order and quotes submitted by Users in the same manner. The Exchange also notes that many of the proposed price protections and risk controls are either User-determined or altogether voluntary.
In addition to this, the Exchange does not believe that the proposed rule change will impose any burden on intermarket competition that is not necessary or appropriate in furtherance of the purposes of the Act because the basis for the majority of the proposed rule changes in this filing are the rules of C2 and EDGX, which have previously been filed with the Commission. The Exchange also notes that market participants on other exchanges are welcome to become participants on the Exchange if they determine that this proposed rule change has made Cboe Options a more attractive or favorable venue. As stated, the proposed changes to the rules that accurately reflect functionality that will be in place come October 7, 2019, will not impose any burden on intermarket competition that is not necessary or appropriate in furtherance of the purposes of the Act but rather provide clear, consistent rules for market participants surrounding the completion of migration.
The Exchange neither solicited nor received comments on the proposed rule change.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
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:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Securities and Exchange Commission (“Commission”).
Notice.
Notice of an application for an order under section 12(d)(1)(J) of the Investment Company Act of 1940 (the “Act”) for an exemption from sections 12(d)(1)(A), (B), and (C) of the Act and under sections 6(c) and 17(b) of the Act for an exemption from sections 17(a)(1) and (2) of the Act. The requested order would permit certain registered open-end investment companies to acquire shares of certain registered open-end investment companies (each an “Unaffiliated Open-End Investment Company”), registered closed-end investment companies and “business development companies,” as defined in section 2(a)(48) of the Act (each registered closed-end management and each business development company, an “Unaffiliated Closed-End Investment Company” and, together with the Unaffiliated Open-End Investment Companies, the “Unaffiliated Investment Companies”), and registered unit investment trusts (the “Unaffiliated Trusts,” and together with the Unaffiliated Investment Companies, the “Unaffiliated Funds”) that are within the same group of investment companies (collectively, the “Affiliated Funds”) and outside the same group of investment companies as the acquiring investment companies (collectively, the Affiliated Funds and, together with the Unaffiliated Funds, the “Underlying Funds”), in excess of the limits in section 12(d)(1) of the Act.
ETFis Series Trust I and Virtus ETF Trust II, Delaware statutory trusts that are registered under the Act as open-end management investment companies and intend to introduce multiple series, and Virtus ETF Advisers LLC, a Delaware limited liability company registered as an investment adviser under the Investment Advisers Act of 1940.
The application was filed on May 9, 2019.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicants with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on October 7, 2019 and should be accompanied by proof of service on the applicants, in the form of an affidavit, or, for lawyers, a certificate of service. Pursuant to Rule 0-5 under the Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.
Secretary, U.S. Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090. Applicants: William J. Smalley, Virtus ETF Advisers LLC, 1540 Broadway, New York, NY 10036; and Michael W. Mundt, Esq., Stradley Ronon Stevens & Young, LLP, 1250 Connecticut Avenue NW, Suite 500, Washington, DC 20036.
Rochelle Kauffman Plesset, Senior Counsel, or David J. Marcinkus, Branch Chief, at (202) 551-6825, (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete application may be obtained via the Commission's website by searching for the file number, or for an applicant using the Company name box, at
1. Applicants request an order to permit (a) a Fund
2. Applicants agree that any order granting the requested relief will be subject to the terms and conditions stated in the application. Such terms and conditions are designed to, among other things, help prevent any potential
3. Section 12(d)(1)(J) of the Act provides that the Commission may exempt any person, security, or transaction, or any class or classes of persons, securities, or transactions, from any provision of section 12(d)(1) if the exemption is consistent with the public interest and the protection of investors. Section 17(b) of the Act authorizes the Commission to grant an order permitting a transaction otherwise prohibited by section 17(a) if it finds that (a) the terms of the proposed transaction are fair and reasonable and do not involve overreaching on the part of any person concerned; (b) the proposed transaction is consistent with the policies of each registered investment company involved; and (c) the proposed transaction is consistent with the general purposes of the Act. Section 6(c) of the Act permits the Commission to exempt any persons or transactions from any provision of the Act if such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act.
For the Commission, by the Division of Investment Management, pursuant to delegated authority.
Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94-409, the Securities and Exchange Commission will hold an Open Meeting on Wednesday, September 18, 2019 at 10:00 a.m.
The meeting will be held in Auditorium LL-002 at the Commission's headquarters, 100 F Street NE, Washington, DC 20549.
This meeting will begin at 10:00 a.m. (ET) and will be open to the public. Seating will be on a first-come, first-served basis. Visitors will be subject to security checks. The meeting will be webcast on the Commission's website at
1. The Commission will consider whether to adopt amendments to rules adopted under section 13 of the Bank Holding Company Act related to prohibitions and restrictions on proprietary trading and certain interests in, and relationships with, hedge funds and private equity funds (commonly known as the “Volcker rule”).
At times, changes in Commission priorities require alterations in the scheduling of meeting items.
For further information and to ascertain what, if any, matters have been added, deleted or postponed, please contact Vanessa A. Countryman, Office of the Secretary, at (202) 551-5400.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend the NYSE American Options Fee Schedule (“Fee Schedule”). The Exchange proposes to implement the fee change effective September 3, 2019. The proposed change is available on the Exchange's website at
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.
The purpose of this filing is to amend the Fee Schedule to modify the Strategy Execution Fee Cap (“Strategy Cap”), as set forth below.
Currently, Section I.J. of the Fee Schedule provides that transaction fees for ATP Holders are limited or capped at $750 for certain options strategy executions “on the same trading day in the same option class” and such fees are further capped at $25,000 per month per initiating firm.
The Exchange proposes to increase the daily Strategy Cap from $750 to $1,000 and to include in the Cap all Strategy Executions traded in the same day (
The Exchange proposes to implement the rule change on September 3, 2019.
The Commission has repeatedly expressed its preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
There are currently 16 registered options exchanges competing for order flow. Based on publicly-available information, and excluding index-based options, no single exchange has more than 16% of the market share of executed volume of multiply-listed equity and ETF options trades.
The Exchange believes that the ever-shifting market share among the exchanges from month to month demonstrates that market participants can shift order flow, or discontinue or reduce use of certain categories of products, in response to fee changes. Accordingly, competitive forces constrain options exchange transaction fees.
In response to this competitive environment, the Exchange has established incentives, such as the Strategy Cap, to encourage ATP Holders to participate in certain large volume options strategies that capture potentially small profits by capping the fees paid for such transactions.
As noted above, the current Strategy Cap limits or caps at $750 transaction fees for options Strategy Executions “on the same trading day in the same option class” and further caps such fees at $25,000 per month.
The Exchange proposes to modify the Strategy Cap by eliminating the requirement that Strategy Executions on the same trading day all be in the same symbol for inclusion in the Cap. Specifically, as proposed, the daily Strategy Cap on transaction fees for options Strategy Executions would be changed from $750 to $1,000 and would apply to all Strategy Executions by an ATP Holder on the same trading day (regardless of option class/symbol). In addition, given the proposal to cap an ATP Holder's fee for all Strategy Executions in a given trading day at $1,000, the Exchange proposed to eliminate the $25,000 per month Strategy Cap as unnecessary.
For example, per the current Fee Schedule, an ATP Holder that executes the following Strategy Executions on the same trading day would be charged as follows:
• A Jelly Roll in ABC for $800 in fees, capped at $750;
• A Reversal Conversion in DEF for $500 in fees; and
• A Merger Spread in XYZ for $600.
The total fees for these Strategy Executions under the current Fee Schedule would be $1,850. Under the proposed Strategy Cap, the same trades would be billed as follows:
• A Jelly Roll in ABC for $800 in fees;
• A Reversal Conversion in DEF for $500 in fees; and
• A Merger Spread in XYZ for $600.
The total fees for these Strategy Executions under the proposed Fee Schedule would be $1,000. Thus, although the amount of the Cap would be increased, the number of eligible Strategy Executions would also be increased, making it easier to meet the Strategy Cap.
The Exchange's fees are constrained by intermarket competition, as ATP Holders may direct their order flow to any of the 16 options exchanges, including those with similar Strategy Fee Caps.
The Exchange cannot predict with certainty whether any ATP Holders would avail themselves of this proposed fee change. At present, whether or when an ATP Holder qualifies for the current daily Strategy Cap (of $750) varies day-to-day in a given month. Thus, the Exchange cannot predict with any certainty the number of ATP Holders that may qualify for the modified Strategy Cap, but believes that ATP Holders would be encourage to take advantage of the modified Cap. The Exchange believes the proposed Strategy Cap, which applies to all qualifying strategies executed on the same trading day, regardless of symbol, would provide an incentive for ATP Holders to submit these types of strategy orders to the Exchange Trading Floor, which brings increased liquidity and order flow for the benefit of all market participants.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange operates in a highly competitive market. The Commission has repeatedly expressed its preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
There are currently 16 registered options exchanges competing for order flow. Based on publicly-available information, and excluding index-based options, no single exchange has more than 16% of the market share of executed volume of multiply-listed equity and ETF options trades.
The Exchange believes that the ever-shifting market share among the exchanges from month to month demonstrates that market participants can shift order flow, or discontinue or reduce use of certain categories of products, in response to fee changes. Accordingly, competitive forces constrain options exchange transaction fees. Stated otherwise, changes to exchange transaction fees can have a direct effect on the ability of an exchange to compete for order flow.
The Exchange believes that the proposed modification to the Strategy Cap is designed to incent ATP Holders to increase the number and type of Strategy Executions sent to the Exchange. In addition, the proposal caps fees on all similar transactions, regardless of size and similarly-situated ATP Holders can opt to try to achieve the modified Strategy Cap. The proposal is designed to encourage ATP Holders to send all Strategy Executions to the Exchange regardless of size or type. To the extent that the proposed change attracts more Strategy Executions to the Exchange Trading Floor, this increased order flow would continue to make the Exchange a more competitive venue for, among other things, order execution, which, in turn, promotes just and equitable principles of trade and removes impediments to and perfects the mechanism of a free and open market and a national market system.
Finally, to the extent the proposed change continues to attract greater volume and liquidity (to the Floor or otherwise), the Exchange believes the proposed change would improve the Exchange's overall competitiveness and strengthen its market quality for all market participants. In the backdrop of the competitive environment in which the Exchange operates, the proposed rule change is a reasonable attempt by the Exchange to increase the depth of its market and improve its market share relative to its competitors. The Exchange's fees are constrained by intermarket competition, as ATP Holders may direct their order flow to any of the 16 options exchanges, including those with similar Strategy Fee Caps.
The Exchange cannot predict with certainty whether any ATP Holders would avail themselves of this proposed fee change. At present, whether or when an ATP Holder qualifies for the current daily Strategy Cap (of $750) varies day-to-day in a given month. Thus, the Exchange cannot predict with any certainty the number of ATP Holders that may qualify for the modified Strategy Cap, but believes that ATP Holders would be encourage to take advantage of the modified Cap. The Exchange believes the proposed Strategy Cap, which applies to all qualifying strategies executed on the same trading day, regardless of symbol, would provide an incentive for ATP Holders to submit these types of strategy orders to the Exchange Trading Floor, which brings increased liquidity and order flow for the benefit of all market participants.
The Exchange believes the proposed rule change is an equitable allocation of its fees and credits. The proposal is based on the amount and type of business transacted on the Exchange and ATP Holders can opt to avail themselves of the Strategy Cap or not. Moreover, the proposal is designed to encourage ATP Holders to aggregate all Strategy Executions at the Exchange as a primary execution venue. To the extent that the proposed change attracts more Strategy Executions to the Exchange, this increased order flow would continue to make the Exchange a more competitive venue for, among other things, order execution. Thus, the Exchange believes the proposed rule change would improve market quality for all market participants on the Exchange and, as a consequence, attract more order flow to the Exchange thereby improving market-wide quality and price discovery.
The Exchange believes it is not unfairly discriminatory to modify the Strategy Cap because the proposed modification would be available to all similarly-situated market participants on an equal and non-discriminatory basis.
The proposal is based on the amount and type of business transacted on the Exchange and ATP Holders are not obligated to try to achieve the Strategy Cap. Rather, the proposal is designed encourage ATP Holders to utilize the Exchange as a primary trading venue for Strategy Executions (if they have not done so previously) or increase volume sent to the Exchange. To the extent that the proposed change attracts more Strategy Executions to the Exchange, this increased order flow would continue to make the Exchange a more competitive venue for, among other things, order execution. Thus, the Exchange believes the proposed rule change would improve market quality for all market participants on the Exchange and, as a consequence, attract more order flow to the Exchange thereby improving market-wide quality and price discovery. The resulting increased volume and liquidity would provide more trading opportunities and tighter spreads to all market participants and thus would promote just and equitable principles of trade, remove impediments to and perfect the mechanism of a free and open market
Finally, the Exchange believes that it is subject to significant competitive forces, as described below in the Exchange's statement regarding the burden on competition.
For the foregoing reasons, the Exchange believes that the proposal is consistent with the Act.
In accordance with Section 6(b)(8) of the Act, the Exchange does not believe that the proposed rule change would impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. Instead, as discussed above, the Exchange believes that the proposed changes would encourage the submission of additional liquidity to a public exchange, thereby promoting market depth, price discovery and transparency and enhancing order execution opportunities for all market participants. As a result, the Exchange believes that the proposed change furthers the Commission's goal in adopting Regulation NMS of fostering integrated competition among orders, which promotes “more efficient pricing of individual stocks for all types of orders, large and small.”
The Exchange believes that the proposed rule change reflects this competitive environment because it modifies the Exchange's fees in a manner designed to encourage ATP Holders to direct trading interest (particularly Strategy Executions) to the Exchange, to provide liquidity and to attract order flow. To the extent that this purpose is achieved, all the Exchange's market participants should benefit from the improved market quality and increased opportunities for price improvement.
The Exchange believes that the proposed change could promote competition between the Exchange and other execution venues, including those that currently offer similar Strategy Caps, by encouraging additional orders to be sent to the Exchange for execution. The Exchange also believes that the proposed change is designed to provide the public and investors with a Fee Schedule that is clear and consistent, thereby reducing burdens on the marketplace and facilitating investor protection.
No written comments were solicited or received with respect to the proposed rule change.
The foregoing rule change is effective upon filing pursuant to Section 19(b)(3)(A)
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)
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:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 350l-3520), the Securities and Exchange Commission (the “Commission”) has submitted to the Office of Management and Budget a request for extension and approval of the collection of information discussed below.
In Canada, as in the United States, individuals can invest a portion of their earnings in tax-deferred retirement savings accounts (“Canadian retirement accounts”). These accounts, which operate in a manner similar to individual retirement accounts in the United States, encourage retirement savings by permitting savings on a tax-deferred basis. Individuals who establish Canadian retirement accounts while living and working in Canada and who later move to the United States (“Canadian-U.S. Participants” or “participants”) often continue to hold their retirement assets in their Canadian retirement accounts rather than prematurely withdrawing (or “cashing out”) those assets, which would result in immediate taxation in Canada.
Once in the United States, however, these participants historically have been unable to manage their Canadian retirement account investments. Most investment companies (“funds”) that are “qualified companies” for Canadian retirement accounts are not registered under the U.S. securities laws. Securities of those unregistered funds, therefore, generally cannot be publicly offered and sold in the United States without violating the registration requirement of the Investment Company Act of 1940 (“Investment Company Act”).
The Commission issued a rulemaking in 2000 that enabled Canadian-U.S. Participants to manage the assets in their Canadian retirement accounts by providing relief from the U.S. registration requirements for offers of securities of foreign issuers to Canadian-U.S. Participants and sales to Canadian retirement accounts.
Rule 7d-2 contains a “collection of information” requirement within the meaning of the Paperwork Reduction Act of 1995.
Rule 7d-2 requires written offering documents for securities offered or sold in reliance on the rule to disclose prominently that the securities are not registered with the Commission and may not be offered or sold in the United States unless registered or exempt from registration under the U.S. securities laws, and also to disclose prominently that the fund that issued the securities is not registered with the Commission. The burden under the rule associated with adding this disclosure to written offering documents is minimal and is non-recurring. The foreign issuer, underwriter, or broker-dealer can redraft an existing prospectus or other written offering material to add this disclosure statement, or may draft a sticker or supplement containing this disclosure to be added to existing offering materials. In either case, based on discussions with representatives of the Canadian fund industry, the staff estimates that it would take an average of 10 minutes per document to draft the requisite disclosure statement.
The staff estimates that there are 4,086 publicly offered Canadian funds that potentially would rely on the rule to offer securities to participants and sell securities to their Canadian retirement accounts without registering under the Investment Company Act.
These burden hour estimates are based upon the Commission staff's experience and discussions with the fund industry. The estimates of average burden hours are made solely for the purposes of the Paperwork Reduction Act. These estimates are not derived from a comprehensive or even a representative survey or study of the costs of Commission rules.
Compliance with the collection of information requirements of the rule is mandatory and is necessary to comply with the requirements of the rule in general. Responses will not be kept confidential. 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 control number.
The public may view the background documentation for this information collection at the following website,
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to list and trade the common shares of beneficial interest of the Invesco BulletShares 2021 Municipal Bond ETF, Invesco BulletShares 2022 Municipal Bond ETF, Invesco BulletShares 2023 Municipal Bond ETF, Invesco BulletShares 2024 Municipal Bond ETF, Invesco BulletShares 2025 Municipal Bond ETF, Invesco BulletShares 2026 Municipal Bond ETF, Invesco BulletShares 2027 Municipal Bond ETF, Invesco BulletShares 2028 Municipal Bond ETF and Invesco BulletShares 2029 Municipal Bond ETF (each a “Fund” or, collectively, the “Funds”), all of which are series of Invesco Exchange-Traded Self-Indexed Fund Trust (the “Trust”), under Nasdaq Rule 5705 (“Rule 5705”). The common shares of beneficial interest of the Funds are referred to herein as the “Shares.”
The text of the proposed rule change is available on the Exchange's website at
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.
The Exchange proposes to list and trade the Shares under Rule 5705, which rule governs the listing and trading of Index Fund Shares
The Shares will be offered by the respective Funds, each of which will be a passively-managed exchange-traded fund (“ETF”). Each Fund is a series of the Trust. The Trust was established as a Delaware statutory trust on October 30, 2015. The Trust is registered with the Commission as an open-end management investment company and has filed a post-effective amendment to its registration statement on Form N-1A (the “Registration Statement”) with the Commission to register the Funds and their Shares under the Investment Company Act of 1940, as amended, (the “1940 Act”) and the Securities Act of 1933.
Invesco Capital Management LLC will serve as the investment adviser (the “Adviser”) to each Fund. Invesco Distributors, Inc. will serve as the principal underwriter and distributor of the Shares (the “Distributor”). The Bank of New York Mellon will act as the custodian, transfer agent and fund accounting agent for the Funds (the “Custodian”). The Bank of New York Mellon will also serve as the administrator for the Funds (the “Administrator”).
Nasdaq Rule 5705(b)(4)(B)(i) provides that, if an investment company issuing Index Fund Shares tracks an index that is maintained by a broker-dealer or fund advisor, such broker-dealer or fund advisor shall erect and maintain a “fire wall” around the personnel who have access to information concerning changes and adjustments to the index and the index shall be calculated by a third party who is not a broker-dealer or fund advisor. In addition, Nasdaq Rule 5705 further requires that any advisory committee, supervisory board, or similar entity that makes decisions on the index composition, methodology and related matters, must implement and maintain, or be subject to, procedures designed to prevent the use and dissemination of material non-public information regarding the applicable index.
The index provider for the Underlying Indexes is Invesco Indexing LLC (the “Index Provider”). The Index Provider is not a broker-dealer or fund advisor, but it is affiliated with the Distributor, a broker-dealer, the Adviser, a fund advisor, and other affiliates that are broker-dealers and fund advisors. The Index Provider has therefore implemented and will maintain a fire wall around the personnel who have access to information concerning changes and adjustments to the Underlying Indexes. In the event a Fund changes its underlying index to an index maintained by a different index provider, such index provider will implement and maintain a fire wall as required. The Index Provider has also implemented policies and procedures designed to prevent the use and dissemination of material non-public information regarding the applicable index by Index Provider personnel that make decisions on each Underlying Index's composition, methodology and related matters.
Additionally, the calculation agent for each Underlying Index is ICE Data Indices, LLC (“ICE”), a third party who is not a broker-dealer or fund advisor. ICE does not participate in the composition or methodology of the Underlying Indexes.
The Adviser is not a broker-dealer, but is affiliated with a broker-dealer and has implemented and will maintain a “fire wall” with respect to its broker-dealer affiliate regarding access to information concerning the composition and/or changes to each Fund's portfolio. In the event (a) the Adviser becomes newly affiliated with a different broker-dealer (or becomes a registered broker-dealer itself), or (b) any new adviser or sub-adviser to a Fund is a registered broker-dealer or becomes affiliated with a broker-dealer, each will implement and maintain a fire wall with respect to its relevant personnel and/or such broker-dealer affiliate, as applicable, regarding access to information concerning the composition and/or changes to each Fund's portfolio and will be subject to procedures designed to prevent the use and dissemination of material non-public information regarding each Fund's portfolio.
Each of the Funds will be a passively-managed ETF with investment objective to seek to track the investment results (before fees and expenses) of the following Underlying Indexes.
Each Fund will seek to achieve its investment objective by investing, under normal market conditions,
To be included in the Underlying Indexes, a Municipal Bond must (i) be exempt from federal income tax; (ii) be rated at least BBB- by S&P Global Ratings, a division of S&P Global Inc. (“S&P”) or Fitch Ratings Inc. (“Fitch”), or at least Baa3 by Moody's Investors Service, Inc. (“Moody's”); and (iii) have at least $15 million in face value outstanding (if a bond has already been included in an Underlying Index, then it need only have at least 80% of the initial minimum face value qualification ($12 million in face value outstanding) to remain within the Underlying Index at rebalance). Bonds selected for inclusion in an Underlying Index are market value weighted, and the bonds of individual issuers are collectively limited to a maximum weighting of 5% prior to the final year of maturity of the Underlying Index.
Prior to the final year of maturity of an Underlying Index (
If a bond is removed from an Underlying Index during any monthly rebalance, such bond will be excluded for the next three monthly rebalances (including the current rebalance).
During the final year of maturity (
The Municipal Bonds in which a Fund invests have an actual or effective year of maturity in the year indicated by its name, and each Fund will terminate on or about December 15 of such year. For example, the Invesco BulletShares 2021 Municipal Bond ETF will terminate on or about December 15, 2021. The Board of Trustees of the Trust (the “Board”) may change the termination date to an earlier or later date without shareholder approval. In the final year of operation, when the Municipal Bonds held by a Fund are called or mature, the proceeds will not be reinvested in the Municipal Bonds within the Underlying Index but instead, in connection with the Underlying Index's transition to VRDOs, the Fund's portfolio will transition to any combination of VRDOs,
Each Fund has elected and intends to qualify each year as a “regulated investment company” (sometimes referred to as a “RIC”) under Subchapter M of Chapter 1 of Subtitle A of the
While under normal market conditions a Fund will invest at least 80% of its assets pursuant to the Index Tracking Policy described above, each Fund may invest its remaining assets in VRDOs, certain derivatives, ETFs, including ETFs advised by the Adviser, cash and cash equivalents, including shares of money market funds advised by the Adviser or its affiliates and short-term investment grade commercial paper,
Each Fund may hold up to an aggregate amount of 15% of its net assets in illiquid assets (calculated at the time of investment), including commercial instruments deemed illiquid by the Adviser.
Each Fund's investments will be consistent with the Fund's investment objective. A Fund's investments will not be used to enhance leverage. That is, while a Fund will be permitted to borrow as permitted under the 1940 Act, no Fund will be operated as a “leveraged ETF,”
Each Fund will seek to track the investment results (before fees and expenses) of its Underlying Index. The Exchange is submitting this proposed rule change because the Underlying Index for each Fund does not meet all of the “generic” listing requirements of Rule 5705(b)(4)(A) applicable to the listing of Index Fund Shares based on fixed income securities indexes. Each Underlying Index (both prior to its final year of maturity, and as it transitions to VRDOs in its final year) meets all such requirements except for those set forth in Rule 5705(b)(4)(A)(ii).
As of May 31, 2019, 94.34% of the weight of the 2021 Index components was comprised of individual bonds that were part of a larger Municipal Bond offering with a total minimum original principal amount outstanding of $100 million or more for all bonds within the offering in aggregate. In addition, the aggregate face amount outstanding of bonds in the 2021 Index was approximately $94.63 billion, the total market value of the bonds was approximately $102.44 billion, and the average face amount outstanding per bond in the 2021 Index was approximately $38.40 million. Further, the most heavily weighted component represented 0.85% of the weight of the 2021 Index and the aggregate weight of the five most heavily weighted components represented 2.85% of the weight of the 2021 Index.
Given these statistics, and the fact that the 2021 Index is comprised of over 500 bonds (as of May 31, 2019, the 2021 Index was composed of 2,464 bonds from issuers in 52 different states or U.S. territories), the Exchange believes that, notwithstanding that the 2021 Index does not satisfy the criterion in Rule 5705(b)(4)(A)(ii), the 2021 Index is sufficiently broad-based to deter potential manipulation. In addition, a substantial portion (94.34%) of the 2021 Index weight is comprised of bonds that were part of a larger municipal offering with a total minimum original principal amount outstanding of $100 million or more in aggregate, and in view of the substantial aggregate face amount outstanding of the bonds and the average face amount outstanding per 2021 Index component, as referenced above.
As of May 31, 2019, 93.74% of the weight of the 2022 Index components was comprised of individual bonds that were part of a larger Municipal Bond offering with a total minimum original principal amount outstanding of $100 million or more for all bonds within the offering in aggregate. In addition, the aggregate face amount outstanding of bonds in the 2022 Index was approximately $110.53 billion, the total market value of the bonds was approximately $121.58 billion, and the average face amount outstanding per bond in the 2022 Index was approximately $38.46 million. Further, the most heavily weighted component represented 0.45% of the weight of the 2022 Index and the aggregate weight of the five most heavily weighted components represented 2.03% of the weight of the 2022 Index.
Given these statistics, and the fact that the 2022 Index is comprised of over 500 bonds (as of May 31, 2019, the 2022 Index was composed of 2,874 bonds from issuers in 51 different states or U.S. territories), the Exchange believes that, notwithstanding that the 2022 Index does not satisfy the criterion in Rule 5705(b)(4)(A)(ii), the 2022 Index is sufficiently broad-based to deter potential manipulation. In addition, a substantial portion (93.74%) of the 2022 Index weight is comprised of bonds that were part of a larger municipal offering
As of May 31, 2019, 92.87% of the weight of the 2023 Index components was comprised of individual bonds that were part of a larger Municipal Bond offering with a total minimum original principal amount outstanding of $100 million or more for all bonds within the offering in aggregate. In addition, the aggregate face amount outstanding of bonds in the 2023 Index was approximately $98.34 billion, the total market value of the bonds was approximately $111.13 billion, and the average face amount outstanding per bond in the 2023 Index was approximately $40.24 million. Further, the most heavily weighted component represented 0.61% of the weight of the 2023 Index and the aggregate weight of the five most heavily weighted components represented 2.80% of the weight of the 2023 Index.
Given these statistics, and the fact that the 2023 Index is comprised of over 500 bonds (as of May 31, 2019, the 2023 Index was composed of 2,444 bonds from issuers in 49 different states or U.S. territories), the Exchange believes that, notwithstanding that the 2023 Index does not satisfy the criterion in Rule 5705(b)(4)(A)(ii), the 2023 Index is sufficiently broad-based to deter potential manipulation. In addition, a substantial portion (92.87%) of the 2023 Index weight is comprised of bonds that were part of a larger municipal offering with a total minimum original principal amount outstanding of $100 million or more in aggregate, and in view of the substantial aggregate face amount outstanding of the bonds and the average face amount outstanding per 2023 Index component, as referenced above. Further, 48.68% of the 2023 Index weight consisted of bonds with a rating of AA/Aa2 or higher.
As of May 31, 2019, 94.81% of the weight of the 2024 Index components was comprised of individual bonds that were part of a larger Municipal Bond offering with a total minimum original principal amount outstanding of $100 million or more for all bonds within the offering in aggregate. In addition, the aggregate face amount outstanding of bonds in the 2024 Index was approximately $95.12 billion, the total market value of the bonds was approximately $109.47 billion, and the average face amount outstanding per bond in the 2024 Index was approximately $38.78 million. Further, the most heavily weighted component represented 0.53% of the weight of the 2024 Index and the aggregate weight of the five most heavily weighted components represented 2.38% of the weight of the 2024 Index.
Given these statistics, and the fact that the 2024 Index is comprised of over 500 bonds (as of May 31, 2019, the 2024 Index was composed of 2,453 bonds from issuers in 48 different states or U.S. territories), the Exchange believes that, notwithstanding that the 2024 Index does not satisfy the criterion in Rule 5705(b)(4)(A)(ii), the 2024 Index is sufficiently broad-based to deter potential manipulation. In addition, a substantial portion (94.81%) of the 2024 Index weight is comprised of bonds that were part of a larger municipal offering with a total minimum original principal amount outstanding of $100 million or more in aggregate, and in view of the substantial aggregate face amount outstanding of the bonds and the average face amount outstanding per 2024 Index component, as referenced above. Further, 54.14% of the 2024 Index weight consisted of bonds with a rating of AA/Aa2 or higher.
As of May 31, 2019, 93.72% of the weight of the 2025 Index components was comprised of individual bonds that were part of a larger Municipal Bond offering with a total minimum original principal amount outstanding of $100 million or more for all bonds within the offering in aggregate. In addition, the aggregate face amount outstanding of bonds in the 2025 Index was approximately $101.69 billion, the market value of the bonds was approximately $118.29 billion, and the average face amount outstanding per bond in the 2025 Index was approximately $37.73 million. Further, the most heavily weighted component represented 0.57% of the weight of the 2025 Index and the aggregate weight of the five most heavily weighted components represented 2.11% of the weight of the 2025 Index.
Given these statistics, and the fact that the 2025 Index is comprised of over 500 bonds (as of May 31, 2019, the 2025 Index was composed of 2,695 bonds from issuers in 48 different states or U.S. territories), the Exchange believes that, notwithstanding that the 2025 Index does not satisfy the criterion in Rule 5705(b)(4)(A)(ii), the 2025 Index is sufficiently broad-based to deter potential manipulation. In addition, a substantial portion (93.72%) of the 2025 Index weight is comprised of bonds that were part of a larger municipal offering with a total minimum original principal amount outstanding of $100 million or more in aggregate, and in view of the substantial aggregate face amount outstanding of the bonds and the average face amount outstanding per 2025 Index component, as referenced above. Further, 52.78% of the 2025 Index weight consisted of bonds with a rating of AA/Aa2 or higher.
As of May 31, 2019, 95.07% of the weight of the 2026 Index components was comprised of individual bonds that were part of a larger Municipal Bond offering with a total minimum original principal amount outstanding of $100 million or more for all bonds within the offering in aggregate. In addition, the aggregate face amount outstanding of bonds in the 2026 Index was approximately $112.32 billion, the total market value of the bonds was approximately $131.57 billion, and the average face amount outstanding per bond in the 2026 Index was approximately $36.74 million. Further, the most heavily weighted component represented 0.43% of the weight of the 2026 Index and the aggregate weight of the five most heavily weighted components represented 1.66% of the weight of the 2026 Index.
Given these statistics, and the fact that the 2026 Index is comprised of over 500 bonds (as of May 31, 2019, the 2026 Index was composed of 3,057 bonds from issuers in 47 different states or U.S. territories), the Exchange believes that, notwithstanding that the 2026 Index does not satisfy the criterion in Rule 5705(b)(4)(A)(ii), the 2026 Index is sufficiently broad-based to deter potential manipulation. In addition, a substantial portion (95.07%) of the 2026 Index weight is comprised of bonds that were part of a larger municipal offering with a total minimum original principal amount outstanding of $100 million or more in aggregate, and in view of the substantial aggregate face amount outstanding of the bonds and the average face amount outstanding per 2026 Index component, as referenced above. Further, 50.35% of the 2026 Index weight consisted of bonds with a rating of AA/Aa2 or higher.
As of May 31, 2019, 94.90% of the weight of the 2027 Index components was comprised of individual bonds that
Given these statistics, and the fact that the 2027 Index is comprised of over 500 bonds (as of May 31, 2019, the 2027 Index was composed of 2,619 bonds from issuers in 51 different states or U.S. territories), the Exchange believes that, notwithstanding that the 2027 Index does not satisfy the criterion in Rule 5705(b)(4)(A)(ii), the 2027 Index is sufficiently broad-based to deter potential manipulation. In addition, a substantial portion (94.90%) of the 2027 Index weight is comprised of bonds that were part of a larger municipal offering with a total minimum original principal amount outstanding of $100 million or more in aggregate, and in view of the substantial aggregate face amount outstanding of the bonds and the average face amount outstanding per 2027 Index component, as referenced above. Further, 52.90% of the 2027 Index weight consisted of bonds with a rating of AA/Aa2 or higher.
As of May 31, 2019, 94.63% of the weight of the 2028 Index components was comprised of individual bonds that were part of a larger Municipal Bond offering with a total minimum original principal amount outstanding of $100 million or more for all bonds within the offering in aggregate. In addition, the aggregate face amount outstanding of bonds in the 2028 Index was approximately $74.66 billion, the total market value of the bonds was approximately $89.17 billion, and the average face amount outstanding per bond in the 2028 Index was approximately $42.13 million. Further, the most heavily weighted component represented 0.68% of the weight of the 2028 Index and the aggregate weight of the five most heavily weighted components represented 2.71% of the weight of the 2028 Index.
Given these statistics, and the fact that the 2028 Index is comprised of over 500 bonds (as of May 31, 2019, the 2028 Index was composed of 1,772 bonds from issuers in 48 different states or U.S. territories), the Exchange believes that, notwithstanding that the 2028 Index does not satisfy the criterion in Rule 5705(b)(4)(A)(ii), the 2028 Index is sufficiently broad-based to deter potential manipulation. In addition, a substantial portion (94.63%) of the 2028 Index weight is comprised of bonds that were part of a larger municipal offering with a total minimum original principal amount outstanding of $100 million or more in aggregate, and in view of the substantial aggregate face amount outstanding of the bonds and the average face amount outstanding per 2028 Index component, as referenced above. Further, 54.39% of the 2028 Index weight consisted of bonds with a rating of AA/Aa2 or higher.
As of May 31, 2019, 96.28% of the weight of the 2029 Index components was comprised of individual bonds that were part of a larger Municipal Bond offering with a total minimum original principal amount outstanding of $100 million or more for all bonds within the offering in aggregate. In addition, the aggregate face amount outstanding of bonds in the 2029 Index was approximately $24.27 billion, the total market value of the bonds was approximately $29.19 billion, and the average face amount outstanding per bond in the 2029 Index was approximately $39.15 million. Further, the most heavily weighted component represented 1.18% of the weight of the 2029 Index and the aggregate weight of the five most heavily weighted components represented 5.13% of the weight of the 2029 Index.
Given these statistics, and the fact that the 2029 Index is comprised of over 500 bonds (as of May 31, 2019, the 2029 Index was composed of 620 bonds from issuers in 39 different states or U.S. territories), the Exchange believes that, notwithstanding that the 2029 Index does not satisfy the criterion in Rule 5705(b)(4)(A)(ii), the 2029 Index is sufficiently broad-based to deter potential manipulation. In addition, a substantial portion (96.28%) of the 2029 Index weight is comprised of bonds that were part of a larger municipal offering with a total minimum original principal amount outstanding of $100 million or more in aggregate, and in view of the substantial aggregate face amount outstanding of the bonds and the average face amount outstanding per 2029 Index component, as referenced above. Further, 50.47% of the 2029 Index weight consisted of bonds with a rating of AA/Aa2 or higher.
Each Underlying Index will, on a continuous basis, contain at least 500 component securities. In addition, prior to its final year, at least 90% of the weight of each Underlying Index will be comprised of Municipal Bonds that have an outstanding face amount per bond of at least $10 million and were issued as part of a larger Municipal Bond offering with a total minimum original principal amount outstanding of $100 million or more for all bonds within the offering in aggregate. During its final year, each Underlying Index will transition to VRDOs and, in doing so, at least 90% of the weight of the VRDO components of each Underlying Index will have an outstanding face amount per VRDO of at least $10 million and at least 40% of the weight of the VRDO components of each Underlying Index will have been issued as part of a larger VRDO offering with a total minimum original principal amount outstanding of $100 million or more for all VRDOs within the offering in aggregate.
Further, as each Underlying Index transitions to VRDOs in its final year, the Municipal Bond components that have not been called or matured (and therefore remain in the Underlying Index) will continue to meet the criteria discussed above (
Each Underlying Index value, calculated and disseminated at least once daily, will be available from major market data vendors. The top ten constituents of each Underlying Index, including their coupon rates, maturity dates and weightings, as of the last day of the prior month are disclosed on the Index Provider's website at
Based on the characteristics of the Underlying Indexes and the representations made in the Descriptions of the Underlying Indexes and All Underlying Indexes sections above, the Exchange believes it is appropriate to allow the listing and trading of the Shares. The Underlying Indexes and Funds (both prior to its final year of maturity, and as it transitions to VRDOs in its final year) each satisfy all of the generic listing requirements of Rule 5705(b)(4)(A) applicable to the listing of Index Fund Shares based on fixed income securities indexes, except for the minimum principal amount outstanding requirement of Rule 5705(b)(4)(A)(ii). The Exchange notes that the representations in the Descriptions of the Underlying Indexes and All Underlying Indexes sections include substantially similar representations: (i) Regarding the Municipal Bond components of the Underlying Indexes, to the representations that appear in the Comparable Filing with respect to the S&P AMT-Free Municipal Callable Factor Adjusted 2026 Series Index, the S&P AMT-Free Municipal Callable Factor Adjusted 2027 Series Index, and the S&P AMT-Free Municipal Callable Factor Adjusted 2028 Series Index (collectively, with the S&P AMT-Free Municipal Callable Factor Adjusted 2026 Series Index and the S&P AMT-Free Municipal Callable Factor Adjusted 2027 Series Index, the “Comparable Indexes”); and (ii) regarding the VRDO components of the Underlying Indexes, to the representations that appear in the Comparable VRDO Filing with respect to the Bloomberg US Municipal AMT-Free Weekly VRDO Index (the “Comparable VRDO Index”).
The Comparable Filing included the representation that a bond must be investment-grade and must have an outstanding par value of at least $2 million in order to be included in the Comparable Indexes. Further, the Comparable Filing included a representation that each Comparable Index will have at least 500 constituents on a continuous basis. Similarly, the Comparable VRDO Filing included the representation that at least 90% of the weight of the Comparable VRDO Index would be comprised of securities that have a minimum amount outstanding of $10 million and, further, that the Comparable VRDO Index will have at least 500 constituents on a continuous basis. As noted above, each Underlying Index requires that, in order to remain in the Underlying Index, Municipal Bonds must be investment-grade and maintain a face value outstanding of over $12 million and, as each Underlying Index transitions to VRDOs in its final year, such VRDO components must be investment-grade and maintain a face value outstanding of over $10 million.
In addition, as stated above: (i) Prior to its final year, at least 90% of the weight of each Underlying Index will be comprised of Municipal Bonds that have an outstanding face amount per bond of at least $10 million and were issued as part of a larger Municipal Bond offering with a total minimum original principal amount outstanding of $100 million or more for all bonds within the offering in aggregate; and (ii) during its final year, as each Underlying Index transitions to VRDOs, at least 90% of the weight of the VRDO components of each Underlying Index will have an outstanding face amount per VRDO of at least $10 million and at least 40% of the weight of the VRDO components of each Underlying Index will have been issued as part of a larger VRDO offering with a total minimum original principal amount outstanding of $100 million or more for all VRDOs within the offering in aggregate. Further, the Adviser has represented that each Underlying Index will have at least 500 constituents on a continuous basis.
As such, the Exchange believes that the proposal is consistent with the Exchange Act because the representations regarding the quality and size of the issuances included in each Underlying Index provide a strong degree of protection against index manipulation that is consistent with other proposals that have either been approved for listing and trading by the Commission or were effective upon filing.
The Funds' website
The Funds' website will also include the ticker symbol for the Shares, CUSIP and exchange information, along with additional quantitative information updated on a daily basis, including, for each Fund: (1) Daily trading volume, the prior Business Day's reported NAV, closing price and mid-point of the bid/ask spread at the time of calculation of such NAV (the “Bid/Ask Price”),
Information regarding the Intra-day Indicative Value (“IIV”) of the Shares is disseminated at least every 15 seconds throughout each trading day by the Reporting Authority (as that term is defined in Rule 5705(b)(1)(C)), including through the Nasdaq Information LLC proprietary index data service. However, the IIV should not be
Intraday executable price quotations on Municipal Bonds and VRDOs held by a Fund and other assets held by a Fund not traded on an exchange, including OTC derivatives (OTC options, swaps and forwards) and cash equivalents will be available from major broker-dealer firms or market data vendors, as well as from automated quotation systems, published or other public sources, or online information services. Intra-day and closing price information related to cash and cash equivalents, including money market funds, investment grade short-term commercial paper and investment grade short-term tax-exempt notes, held by each Fund also will be available through subscription services, such as Bloomberg, Markit and Thomson Reuters, which can be accessed by Authorized Participants and other investors. The Municipal Securities Rulemaking Board's (“MSRB”) Electronic Municipal Market Access (“EMMA”) will be a source of price information for Municipal Bonds. For exchange-traded assets, including ETFs, futures, certain options and swaps, such intraday information is available directly from the applicable listing exchange. In addition, price information for U.S. exchange-traded options will be available from the Options Price Reporting Authority.
Information regarding market price and trading volume of the Shares will be continually available on a real-time basis throughout the day on brokers' computer screens and other electronic services, and quotation and last-sale information for the Shares will be available via Nasdaq proprietary quote and trade services, as well as in accordance with the Unlisted Trading Privileges (“UTP”) plan and the Consolidated Tape Association (“CTA”) plans for the Shares. Information regarding the previous day's closing price and trading volume for the Shares will be published daily in the financial section of newspapers.
Additional information regarding the Funds and the Shares, including investment strategies, risks, creation and redemption procedures, fees, portfolio holdings disclosure policies, distributions and taxes, will be included in the Registration Statement. Investors also will be able to obtain the Funds' Statement of Additional Information (“SAI”) and its Trust's Form N-CEN, each of which is filed at least annually. Further, investors will be able to obtain each Fund's Shareholder Reports and its Trust's Form N-CSR, each of which is filed twice a year. The Funds' SAI and Shareholder Reports will be available free upon request from the Trust, and those documents and the Form N-CSR and Form N-CEN may be viewed on-screen or downloaded from the Commission's website at
The Shares will conform to the initial and continued listing criteria applicable to Index Fund Shares, as set forth under Rule 5705, except Rule 5705(b)(4)(A)(ii). The Exchange represents that, for initial and continued listing, each Fund will be in compliance with Rule 10A-3
With respect to trading halts, the Exchange may consider all relevant factors in exercising its discretion to halt or suspend trading in the Shares of a Fund. Nasdaq will halt trading in the Shares under the conditions specified in Nasdaq Rules 4120 and 4121, including the trading pauses under Nasdaq Rules 4120(a)(12). Trading also may be halted because of market conditions or for reasons that, in the view of the Exchange, make trading in the Shares inadvisable. These may include: (1) The extent to which trading is not occurring in the securities and/or the financial instruments constituting the Disclosed Portfolio of a Fund; or (2) whether other unusual conditions or circumstances detrimental to the maintenance of a fair and orderly market are present. Trading in the Shares also will be subject to Nasdaq Rule 5705(b)(9), which sets forth circumstances under which Index Fund Shares may be halted.
Nasdaq deems the Shares to be equity securities, thus rendering trading in the Shares subject to Nasdaq's existing rules governing the trading of equity securities. Regular market session trading, in accordance with Nasdaq Rule 5705(b)(7), will occur between 9:30 a.m. and either 4:00 p.m. or 4:15 p.m. for each series of Index Fund Shares, as specified by Nasdaq. In addition, Nasdaq may designate each series of Index Fund Shares for trading during a pre-market session beginning at 4:00 a.m. and/or a post-market session ending at 8:00 p.m. The Exchange has appropriate rules to facilitate transactions in the Shares during all trading sessions.
The Exchange represents that trading in the Shares will be subject to the existing trading surveillances, administered by the Exchange and also by FINRA, on behalf of the Exchange.
The surveillances referred to above generally focus on detecting securities trading outside their normal patterns, which could be indicative of manipulative or other violative activity. When such situations are detected, surveillance analysis follows and investigations are opened, where appropriate, to review the behavior of all relevant parties for all relevant trading violations. FINRA, on behalf of the Exchange, will communicate as needed regarding trading in the Shares and exchange-traded securities and instruments held by the Funds with other markets and other entities that are members of the ISG,
In addition, the Exchange will communicate as needed and may obtain information regarding trading in the Shares and exchange-traded securities and instruments held by a Fund from markets and other entities that are
In addition, the Exchange also has a general policy prohibiting the distribution of material, non-public information by its employees.
In addition, the Exchange represents that the Shares will comply with all other requirements applicable to Index Fund Shares, which includes requirements relating to the dissemination of key information such as the Underlying Index value, the NAV, and the IIV, rules governing the trading of equity securities, trading hours, trading halts, fire walls for the Index Provider and Adviser, surveillance, and the Information Bulletin, as set forth in Exchange rules applicable to Index Fund Shares and the orders approving such rules.
Prior to the commencement of trading, the Exchange will inform its members in an Information Circular of the special characteristics and risks associated with trading the Shares. Specifically, the Information Circular will discuss the following: (1) The procedures for purchases and redemptions of Shares in Creation Units (and that Shares are not individually redeemable); (2) Nasdaq Rule 2111A, which imposes suitability obligations on Nasdaq members with respect to recommending transactions in the Shares to customers; (3) how information regarding the IIV and the Disclosed Portfolio is disseminated; (4) the risks involved in trading the Shares during the Pre-Market and Post-Market Sessions when an updated IIV will not be calculated or publicly disseminated; (5) the requirement that members purchasing Shares from the Funds for resale to investors deliver a prospectus to investors purchasing newly issued Shares prior to or concurrently with the confirmation of a transaction; and (6) trading information.
In addition, the Information Circular will advise members, prior to the commencement of trading, of the prospectus delivery requirements applicable to each Fund. Members purchasing Shares from the Funds for resale to investors will deliver a prospectus to such investors. The Information Circular will also discuss any exemptive, no-action and interpretive relief granted by the Commission from any rules under the Exchange Act.
Additionally, the Information Circular will reference that each Fund is subject to various fees and expenses. The Information Circular will also disclose the trading hours of the Shares and the applicable NAV calculation time for the Funds. The Information Circular will disclose that information about the Shares will be publicly available on the Funds' website.
All statements and representations made in this filing regarding (a) index composition; (b) the description of the portfolios; (c) limitations on portfolio holdings or reference assets, (d) dissemination and availability of the indexes or intraday indicative values, or (e) the applicability of Exchange listing rules specified in this rule filing shall constitute continued listing requirements for listing the Shares on the Exchange. In addition, the issuer has represented to the Exchange that it will advise the Exchange of any failure by a Fund to comply with the continued listing requirements, and, pursuant to its obligations under Section 19(g)(1) of the Act, the Exchange will monitor for compliance with the continued listing requirements. If a Fund is not in compliance with the applicable listing requirements, the Exchange will commence delisting procedures under the Nasdaq 5800 Series.
Nasdaq believes that the proposal is consistent with Section 6(b) of the Exchange Act, in general, and Section 6(b)(5)
The Exchange believes that the proposed rule change is designed to prevent fraudulent and manipulative acts and practices in that the Shares will be listed and traded on the Exchange pursuant to the initial and continued listing criteria in Nasdaq Rule 5705 (with the exception of Rule 5705(b)(4)(A)(ii)). The Exchange represents that trading in the Shares will be subject to the existing trading surveillances, administered by the Exchange and also by FINRA, on behalf of the Exchange. Such trading surveillances are designed to deter and detect violations of Exchange rules and applicable federal securities laws and are adequate to properly monitor trading in the Shares in all trading sessions.
The Adviser is not a broker-dealer, but is affiliated with a broker-dealer and has implemented and will maintain a “fire wall” with respect to its broker-dealer affiliate regarding access to information concerning the composition and/or changes to each Fund's portfolio. In the event (a) the Adviser becomes newly affiliated with a different broker-dealer (or becomes a registered broker-dealer itself), or (b) any new adviser or sub-adviser to a Fund is a registered broker-dealer or becomes affiliated with a broker-dealer, each will implement and maintain a fire wall with respect to its relevant personnel and/or such broker-dealer affiliate, as applicable, regarding access to information concerning the composition and/or changes to each Fund's portfolio and will be subject to procedures designed to prevent the use and dissemination of material non-public information regarding each Fund's portfolio.
In addition, Nasdaq Rule 5705(b)(4)(B)(i) requires that if an Index Fund Share's underlying index maintained by a broker-dealer or fund advisor, the broker-dealer or fund advisor shall erect and maintain a “fire wall” around the personnel who have access to information concerning changes and adjustments to the index and the index shall be calculated by a third party who is not a broker-dealer or fund advisor. In addition, Nasdaq Rule 5705 further requires that any advisory committee, supervisory board, or similar entity that makes decisions on the index composition, methodology and related matters, must implement and maintain, or be subject to, procedures designed to prevent the use and dissemination of material non-public information regarding the applicable index. As noted above, the Index Provider has implemented and will continue to maintain the fire wall required.
The proposed rule change is designed to perfect the mechanism of a free and open market and, in general, to protect investors and the public interest in that it will facilitate the listing and trading of additional types of passively-managed exchange-traded products that will enhance competition among market participants, to the benefit of investors and the marketplace.
As addressed above, the Exchange believes that, notwithstanding that the Underlying Indexes do not satisfy the criterion in Rule 5705(b)(4)(A)(ii), the
The Exchange believes that this significant diversification and the lack of concentration among constituent securities provide each Underlying Index with a strong degree of protection against index manipulation. Each Underlying Index and Fund satisfy all of the generic listing requirements for Index Fund Shares based on a fixed income index, except for the minimum principal amount outstanding requirement of Rule 5705(b)(4)(A)(ii). With this in mind, the Exchange notes that the representations in the Descriptions of the Underlying Indexes and All Underlying Indexes sections are substantially similar to the representations made regarding the Comparable Indexes and the Comparable VRDO Index in the Comparable Filing and Comparable VRDO Filing, respectively.
The Comparable Filing included the representation that a bond must be investment-grade and must have an outstanding par value of at least $2 million in order to be included in the Comparable Indexes. Further, the Comparable Filing included a representation that each Comparable Index will have at least 500 constituents on a continuous basis. Similarly, the Comparable VRDO Filing included the representation that at least 90% of the weight of the Comparable VRDO Index would be comprised of securities that have a minimum amount outstanding of $10 million and, further, that the Comparable VRDO Index will have at least 500 constituents on a continuous basis. As noted above, each Underlying Index requires that, in order to remain in the Underlying Index, Municipal Bonds must be investment-grade and maintain a face value outstanding of over $12 million and, as the Underlying Indexes transition to VRDOs in their final year, VRDO components of the Underlying Indexes must also be investment grade and have a face value outstanding of over $10 million.
In addition, as stated above: (i) Prior to its final year, at least 90% of the weight of each Underlying Index will be comprised of Municipal Bonds that have an outstanding face amount per bond of at least $10 million and were issued as part of a larger Municipal Bond offering with a total minimum original principal amount outstanding of $100 million or more for all bonds within the offering in aggregate; and (ii) during its final year, as each Underlying Index transitions to VRDOs, at least 90% of the weight of the VRDO components of each Underlying Index will have an outstanding face amount per VRDO of at least $10 million and at least 40% of the weight of the VRDO components of each Underlying Index will have been issued as part of a larger VRDO offering with a total minimum original principal amount outstanding of $100 million or more for all VRDOs within the offering in aggregate. Further, the Adviser has represented that each Underlying Index will have at least 500 constituents on a continuous basis.
As such, the Exchange believes that the proposal is consistent with the Exchange Act because the representations regarding the quality and size of the issuances included in each Underlying Index provide a strong degree of protection against index manipulation that is consistent with other proposals that have either been approved for listing and trading by the Commission or were effective upon filing.
The proposed rule change is designed to promote just and equitable principles of trade and to protect investors and the public interest in that the Exchange will obtain a representation from the issuer of the Shares that the NAV per Share will be calculated daily every day that the Funds are traded, and that the NAV and the Disclosed Portfolio will be made available to all market participants at the same time. In addition, a large amount of information will be publicly available regarding the Funds and the Shares, thereby promoting market transparency. Moreover, the IIV, available on the Nasdaq Information LLC proprietary index data service, will be widely disseminated by one or more major market data vendors at least every 15 seconds during the Exchange's Regular Market Session. On each Business Day, before commencement of trading in Shares in the Regular Market Session on the Exchange, the Adviser will disclose on the Funds' website the Disclosed Portfolios of the Funds that will form the basis for each Fund's calculation of NAV at the end of the Business Day.
Information regarding market price and trading volume of the Shares will be continually available on a real-time basis throughout the day on brokers' computer screens and other electronic services, and quotation and last-sale information for the Shares will be available via Nasdaq proprietary quote and trade services, as well as in accordance with the UTP plan and the CTA plans for the Shares.
The Funds' website will include a form of the prospectus for each Fund and additional data relating to NAV and other applicable quantitative information. Moreover, prior to the commencement of trading, the Exchange will inform its members in an Information Circular of the special characteristics and risks associated with trading the Shares. Trading in Shares of the Funds will be halted under the conditions specified in Nasdaq Rules 4120 and 4121 or because of market conditions or for reasons that, in the view of the Exchange, make trading in the Shares inadvisable. In addition, as noted above, investors will have ready access to information regarding each Fund's holdings, the IIV, the Disclosed Portfolio, and quotation and last sale information for the Shares.
For the above reasons, Nasdaq believes the proposed rule change is consistent with the requirements of Section 6(b)(5) of the Exchange Act.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Exchange Act. The Exchange believes that the proposed rule change will facilitate the listing and trading of additional types of passively-managed exchange-traded products that will enhance competition among market participants, to the benefit of investors and the marketplace.
No written comments were either solicited or received.
Because the foregoing 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 for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
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 to determine whether the proposed rule change should be approved or disapproved.
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:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
Cboe Exchange, Inc. (the “Exchange” or “Cboe Options”) proposes to update the Exchange's Rules regarding the Cboe Trade Match System (“CTM”) and move those Rules from the currently effective Rulebook (“current Rulebook”) to the shell structure for the Exchange's Rulebook that will become effective upon the migration of the Exchange's trading platform to the same system used by the Cboe Affiliated Exchanges (as defined below) (“shell Rulebook”). The text of the proposed rule change is provided in Exhibit 5.
The text of the proposed rule change is also available on the Exchange's website (
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.
In 2016, the Exchange's parent company, Cboe Global Markets, Inc. (formerly named CBOE Holdings, Inc.) (“Cboe Global”), which is also the parent company of Cboe C2 Exchange, Inc. (“C2”), acquired Cboe EDGA Exchange, Inc. (“EDGA”), Cboe EDGX Exchange, Inc. (“EDGX” or “EDGX Options”), Cboe BZX Exchange, Inc. (“BZX” or “BZX Options”), and Cboe BYX Exchange, Inc. (“BYX” and, together with Cboe Options, C2, EDGX, EDGA, and BZX, the “Cboe Affiliated Exchanges”). Cboe Options intends to migrate its trading platform to the same system used by the Cboe Affiliated Exchanges, which the Exchange expects to complete on October 7, 2019. In connection with this technology migration, the Exchange has a shell Rulebook that resides alongside its current Rulebook, which shell Rulebook will contain the Rules that will be in place upon completion of the Cboe Options technology migration.
The Exchange proposes to harmonize current Rule 6.67 in connection with the Cboe Trade Match System (“CTM”), which allows authorized Trading Permit Holders (“TPHs”) to add and/or update trade records, to C2 Rule 6.31, which provides for the “Clearing Editor” and is functionally equivalent to CTM. The Exchange now proposes Rule 6.6 in the shell Rulebook, which will govern the Exchange's Clearing Editor upon migration, and to delete Rule 6.67 from the current Rulebook, also upon migration. The Exchange proposes to amend the rule to conform to the Clearing Editor functionality and rule language of that of C2 to the extent necessary to retain intended differences unique to Cboe Options market-model, functionality, and/or rule text, which are identified below. The Exchange also proposes to make non-substantive changes by updating cross-references to rules in the shell Rulebook and rules not yet in the shell Rulebook but that in the Exchange intends to move to the shell Rulebook and, as a result of consolidating and conforming the proposed rule to the corresponding C2 rule, make non-substantive changes that simplify and update the rule text to read in plain English and reformat the paragraph lettering and/or numbering.
Specifically, the Clearing Editor under proposed Rule 6.6, like CTM, allows TPHs to update executed trades on their trading date and revise them for clearing. Proposed Rule 6.6(a) is substantively the same as the current general language under Rule 6.67 and is consistent with corresponding C2 Rule 6.31(a). The Exchange maintains that along with using Clearing Editor to correct certain bona fide errors, TPHs may use it to update information entered pursuant to Rule 6.1 in the shell Rulebook (current Rule 6.51).
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The proposed rule change is intended to align the Exchange's current CTM rule and system functionality with one of the Cboe Affiliated Exchanges, C2, in order to provide a consistent technology offering across the affiliated exchanges upon the technology migration on October 7, 2019. A consistent technology offering, in turn, will simplify the technology implementation, changes and maintenance by TPHs of the Exchange that are also participants on C2. The proposed rule change does not propose to implement new or unique functionality that has not been previously filed with the Commission, found to be consistent with the Act, or is not available on Cboe Affiliated Exchanges. As a result of a consistent Clearing Editor rule and system functionality between the Exchange and C2, the proposed rule change will foster cooperation and coordination with persons engaged in facilitating transactions in securities and remove impediment to and perfect the mechanism of a free and open market and national market system by simplifying the regulatory requirements and increasing the understanding of the Exchange's operations for TPHs that are also participants on C2. The Exchange notes that the proposed rule only makes the above-mentioned minor updates in order to conform to the corresponding C2 rule; including allowing a TPH to change the account and subaccount field (as opposed to only the market-maker account and subaccount currently allowed), updating the term origin code to capacity code (which is both consistent with the C2 rule and the definition in the shell Rulebook), and removing the provision that only allows TPHs to change certain fields if they provide notice to the Exchange. The Exchange believes that these updates will provide harmonization between the functionality and rules across the affiliated exchanges, and, in turn, foster greater uniformity and less burdensome and more efficient regulatory compliance. As stated above, the proposed rule is different only to the extent that it maintains intended differences unique to Cboe Options market-model, functionality, and/or rule text, thereby protecting investors by providing rules that clearly and properly reflect nuances between the Exchange and C2. The Exchange also notes that the proposed rule is substantially the same as the current rule. The proposed rule change makes other various non-substantive changes to the rule, largely in part to make it consistent with C2's rule. The proposed non-substantive changes will protect investors and benefit market participants by simplifying the rules, using plain English throughout the rules, and updating cross-references and paragraph lettering/numbering.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange reiterates that the proposed rule change is being proposed in the context of a technology migration of the Cboe Affiliated Exchanges. As stated, the proposed changes to the rules that reflect functionality that will be in place come October 7, 2019 provide clear rules that accurately reflect post-migration functionality upon the completion of migration. The Exchange believes the proposed rule change will benefit Exchange participants in that it will provide a consistent technology offering for TPHs by the Cboe Affiliated Exchanges. The Exchange does not believe the proposed rule change will impose any burden on intramarket competition because the proposed Clearing Editor will be available to all TPHs, both on the floor and electronically, to update executed trades on their trading date and revise them for clearing in the same manner. The Exchange also does not believe that the proposed rule change will impose any burden on intermarket competition because the basis for the proposed rule change are the rules of C2, which have previously been filed with the Commission.
The Exchange neither solicited nor received comments on the proposed rule change.
Because the foregoing 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 for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
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:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to the Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Rule 602 of Regulation NMS, Dissemination of Quotations in NMS securities, contains two related collections. The first collection of information is found in Rule 602(a).
It is anticipated that twenty-three respondents, consisting of twenty-two national securities exchanges and one national securities association, will collectively respond approximately 5,780,026,336,314 times per year pursuant to Rule 602(a) at 18.22 microseconds per response, resulting in a total annual burden of approximately 30,590 hours. It is anticipated that no respondents will have a reporting burden pursuant to Rule 602(b).
Thus, the aggregate third-party disclosure burden under Rule 602 is 30,590 hours annually which is comprised of 30,590 hours relating to Rule 602(a) and 0 hours relating to Rule 602(b).
Written comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (b) the accuracy of the Commission's estimate of the burden of the proposed collections of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of collections of information on those who are to respond, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
Please direct your written comments to: Charles Riddle, Acting Director/Chief Information Officer, Securities and Exchange Commission, c/o Candace Kenner, 100 F Street NE, Washington, DC 20549, or send an email to:
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
Cboe Exchange, Inc. (the “Exchange” or “Cboe Options”) proposes to amend Rule 4.10(b) regarding the notice requirement in connection with Trading Permit Holders (“TPHs”) that clear Market-Maker trades. The text of the proposed rule change is provided in Exhibit 5.
The text of the proposed rule change is also available on the Exchange's website (
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.
The Exchange proposes to remove the Rule 4.10(b)(2) requirement that the Exchange issue monthly notices regarding a Trading Permit Holder's (“TPH's”) proportion of market making clearing business to TPHs that clear Market-Maker trades.
Current Rule 4.10 generally provides for restrictions that the Exchange may place on “TPHs” that have failed to perform their contracts, are insolvent or in such financial or operational condition or otherwise conducting business in such a manner that they cannot be permitted to continue in business with safety to their customers or creditors or the Exchange. Current Rule 4.10(b) applies specifically to TPHs that clear Market-Maker trades. Rule 4.10(b)(2) provides that proposed Significant Business Transactions (“SBTs”)
In particular, the Exchange has determined that its administrative burden to proactively produce monthly notices, whether or not a Market-Maker clearing TPH's business exceeds the paragraph (b)(2) parameters, greatly exceeds the benefit in administering monthly notices due to the limited number of SBTs actually filed with the Exchange per year. The Exchange also notes that because proposed SBTs are infrequent, the receipt of monthly notices is not an integral part of a TPH's financial and operational maintenance on a month-to-month basis. If a Market-Maker clearing TPH anticipates an SBT that may require prior Exchange approval, then the TPH may contact the Exchange to determine whether the TPH exceeds the parameters. The proposed rule change makes this explicit in the rule. As a result, the Exchange believes that removing the current notice requirement from Rule 4.10(b)(2) will remove burdensome Exchange procedures without impacting the ability of a Market-Maker clearing TPH to assess its clearance activities in light of an SBT or to continue to conduct business on the Exchange.
The restrictions that Rule 4.10 imposes on TPHs will continue to apply. The Exchange notes that removing this administrative burden will also enable the Exchange to better allocate its regulatory resources, focusing on the overall monitoring of TPH business and satisfaction of these restrictions to ensure adequate financial and operational capabilities to continue to perform contracts and otherwise conduct business safely for customers, creditors, and the Exchange. Additionally, the Exchange notes that the corresponding rules of other options exchanges currently do not contain a provision that requires such exchanges to send monthly notice to clearing members or otherwise indicate to their clearing members that they exceed, or may exceed, substantially similar criteria on the respective exchanges as a result of an SBT.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, the Exchange believes that the proposed change will remove impediments to and perfect the mechanism of a free and open market and national market system, and generally protect investors. Specifically, the Exchange believes that by removing an administrative burden in producing monthly notices for all Market-Maker clearing TPHs that greatly outweighs the benefit of such notices, due to the infrequent number of SBTs per year, the Exchange will be able to reallocate regulatory resources to focus on the overall monitoring of TPH business and
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. In particular, the proposed rule change is not intended to address competitive issues but rather is concerned with facilitating less burdensome and more efficient regulatory administration. The Exchange does not believe that the proposed rule change will impose any intramarket competition, because all Market-Maker clearing TPHs are free to contact the Exchange to determine its standing in regard to the SBT parameters. The proposed rule change does not change the restrictions imposed on these TPHs, which will continue to apply to Market-Maker Clearing TPHs in the same manner. Further, the Exchange does not believe the proposed rule change will impose any burden on intermarket competition because the rules of other options exchanges, which have been previously filed with the Commission, provide for substantially similar parameters in connection with the impact of a clearing member's SBTs but do not contain a provision that requires such exchanges to send monthly notice to clearing members or otherwise indicate to their clearing members that they exceed such criteria.
The Exchange neither solicited nor received comments on the proposed rule change.
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 for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
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 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 will institute proceedings to determine whether the proposed rule change should be approved or disapproved.
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:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Rule 17Ad-10 generally requires registered transfer agents to: (1) Create and maintain current and accurate securityholder records; (2) promptly and accurately record all transfers, purchases, redemptions, and issuances, and notify their appropriate regulatory agency if they are unable to do so; (3) exercise diligent and continuous attention in resolving record inaccuracies; (4) disclose to the issuers for whom they perform transfer agent functions and to their appropriate regulatory agency information regarding record inaccuracies; (5) buy-in certain record inaccuracies that result in a physical over issuance of securities; and (6) communicate with other transfer agents related to the same issuer. These requirements assist in the creation and maintenance of accurate securityholder records, enhance the ability to research errors, and ensure the transfer agent is aware of the number of securities that are properly authorized by the issuer, thereby avoiding over issuance.
The rule also has specific recordkeeping requirements. It requires registered transfer agents to retain certificate detail that has been deleted for six years and keep current an accurate record of the number of shares or principal dollar amount of debt securities that the issuer has authorized to be outstanding. These mandatory requirements ensure accurate securityholder records and assist the Commission and other regulatory agencies with monitoring transfer agents and ensuring compliance with the rule. This rule does not involve the collection of confidential information.
There are approximately 333 registered transfer agents. We estimate that the average number of hours necessary for each transfer agent to comply with Rule 17Ad-10 is approximately 80 hours per year, which generates an industry-wide annual burden of 26,640 hours (333 times 80 hours). This burden is primarily of a recordkeeping nature but also includes a small amount of third party disclosure. At an average staff cost of $50 per hour, the industry-wide internal labor cost of compliance (a monetization of the burden hours) is approximately $1,332,000 per year (26,640 × $50).
In addition, we estimate that each transfer agent will incur an annual external cost burden of $18,000 resulting from the collection of information. Therefore, the total annual external cost on the entire transfer agent industry is approximately $5,994,000 ($18,000 times 333). This cost primarily reflects ongoing computer operations and maintenance associated with generating, maintaining, and disclosing or providing certain information required by the rule.
The amount of time any particular transfer agent will devote to Rule 17Ad-10 compliance will vary according to the size and scope of the transfer agent's business activity. We note, however, that at least some of the records, processes, and communications required by Rule 17Ad-10 would likely be maintained, generated, and used for transfer agent business purposes even without the rule.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
The public may view background documentation for this information collection at the following website:
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 201 is a short sale-related circuit breaker rule that, if triggered, imposes a restriction on the prices at which securities may be sold short. Rule 200(g) provides that a broker-dealer may mark certain qualifying sell orders “short exempt.” The information collected under Rule 201's written policies and procedures requirement applicable to trading centers, the written policies and procedures requirement of the broker-dealer provision of Rule 201(c), the written policies and procedures requirement of the riskless principal provision of Rule 201(d)(6), and the “short exempt” marking requirement of Rule 200(g) enable the Commission and self-regulatory organizations (“SROs”) to examine and monitor for compliance with the requirements of Rule 201 and Rule 200(g).
In addition, the information collected under Rule 201's written policies and procedures requirement applicable to trading centers help ensure that trading centers do not execute or display any impermissibly priced short sale orders, unless an order is marked “short exempt,” in accordance with the Rule's requirements. Similarly, the information collected under the written policies and procedures requirement of the broker-dealer provision of Rule 201(c) and the riskless principal provision of Rule 201(d)(6) help to ensure that broker-dealers comply with the requirements of these provisions. The information collected pursuant to the “short exempt” marking requirement of Rule 200(g) also provides an indication to a trading center when it must execute or
It is estimated that SRO and non-SRO respondents registered with the Commission and subject to the collection of information requirements of Rule 201 and Rule 200(g) incur an aggregate annual burden of 1,621,571 hours to comply with the Rules and an aggregate annual external cost of $220,000.
Written comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's estimates of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
Please direct your written comments to: Charles Riddle, Acting Director/Chief Information Officer, Securities and Exchange Commission, c/o Candace Kenner, 100 F Street NE, Washington, DC 20549, or send an email to:
10:30 a.m. on Thursday, September 19, 2019.
The meeting will be held at the Commission's headquarters, 100 F Street NE, Washington, DC 20549.
This meeting will be closed to the public.
Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the closed meeting. Certain staff members who have an interest in the matters also may be present.
In the event that the time, date, or location of this meeting changes, an announcement of the change, along with the new time, date, and/or place of the meeting will be posted on the Commission's website at
The General Counsel of the Commission, or his designee, has certified that, in his opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR 200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10), permit consideration of the scheduled matters at the closed meeting.
The subject matters of the closed meeting will consist of the following topics:
Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings;
Resolution of litigation claims;
Post argument discussion; and
Other matters relating to enforcement proceedings.
At times, changes in Commission priorities require alterations in the scheduling of meeting agenda items that may consist of adjudicatory, examination, litigation, or regulatory matters.
For further information; please contact Vanessa A. Countryman from the Office of the Secretary at (202) 551-5400.
The Social Security Administration (SSA) publishes a list of information collection packages requiring clearance by the Office of Management and Budget (OMB) in compliance with Public Law 104-13, the Paperwork Reduction Act of 1995, effective October 1, 1995. This notice includes revisions, extensions, and corrections of OMB-approved information collections.
SSA is soliciting comments on the accuracy of the agency's burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility, and clarity; and ways to minimize burden on respondents, including the use of automated collection techniques or other forms of information technology. Mail, email, or fax your comments and recommendations on the information collection(s) to the OMB Desk Officer and SSA Reports Clearance Officer at the following addresses or fax numbers.
Or you may submit your comments online through
I. The information collections below are pending at SSA. SSA will submit them to OMB within 60 days from the date of this notice. To be sure we consider your comments, we must receive them no later than November 12, 2019. Individuals can obtain copies of the collection instruments by writing to the above email address.
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II. SSA submitted the information collections below to OMB for clearance. Your comments regarding these information collections would be most useful if OMB and SSA receive them 30 days from the date of this publication. To be sure we consider your comments, we must receive them no later than October 15, 2019. Individuals can obtain copies of the OMB clearance packages by writing to
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Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition “Flesh and Blood: Italian Masterpieces from the Capodimonte Museum,” imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to agreements with the foreign owner or custodian. I also determine that the exhibition or display of the exhibit objects at the Seattle Art Museum, Seattle, Washington, from on or about October 17, 2019, until on or about January 26, 2020; at the Kimbell Art Museum, Fort Worth, Texas, from on or about March 1, 2020, until on or about June 14, 2020; and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these determinations be published in the
Chi D. Tran, Paralegal Specialist, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition “Félix Valloton: Painter of Disquiet,” imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at The Metropolitan Museum of Art, New York, New York, from on or about October 29, 2019, until on or about January 26, 2020, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these determinations be published in the
Chi D. Tran, Paralegal Specialist, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
East Penn Railroad, LLC (ESPN), has filed a verified notice of exemption under 49 CFR 1152 subpart F—
ESPN has certified that: (1) It has not moved any local or overhead traffic over the Line for at least two years; (2) overhead traffic, if there were any, could be rerouted over other lines; (3) no formal complaint filed by a user of rail service on the Line (or by a state or local
Any employee of ESPN adversely affected by the discontinuance of service shall be protected under
Provided no formal expression of intent to file an offer of financial assistance (OFA)
A copy of any petition filed with the Board should be sent to ESPN's representatives, William A. Mullins and Crystal M. Zorbaugh, Baker & Miller PLLC, 2401 Pennsylvania Ave. NW, Suite 300, Washington, DC 20037.
If the verified notice contains false or misleading information, the exemption is void ab initio.
Board decisions and notices are available at
By the Board, Allison C. Davis, Director, Office of Proceedings.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Receipt of petition.
Daimler Vans USA, LLC, (Daimler Vans) on behalf of Daimler AG (DAG) has determined that certain model year (MY) 2016-2018 Mercedes-Benz Metris vans do not fully comply with Federal Motor Vehicle Safety Standard (FMVSS) No. 110,
The closing date for comments on the petition is October 16, 2019.
Interested persons are invited to submit written data, views, and arguments on this petition. Comments must refer to the docket number cited in the title of this notice and may be submitted by any of the following methods:
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• Comments may also be faxed to (202) 493-2251.
Comments must be written in the English language, and be no greater than 15 pages in length, although there is no limit to the length of necessary attachments to the comments. If comments are submitted in hard copy form, please ensure that two copies are provided. If you wish to receive confirmation that comments you have submitted by mail were received, please enclose a stamped, self-addressed postcard with the comments. Note that all comments received will be posted without change to
All comments and supporting materials received before the close of business on the closing date indicated above will be filed in the docket and will be considered. All comments and supporting materials received after the closing date will also be filed and will be considered to the fullest extent possible.
When the petition is granted or denied, notice of the decision will also be published in the
All comments, background documentation, and supporting materials submitted to the docket may be viewed by anyone at the address and times given above. The documents may also be viewed on the internet at
DOT's complete Privacy Act Statement is available for review in a
I.
This notice of receipt, of the Daimler Vans petition, is published under 49 U.S.C. 30118 and 30120 and does not represent any agency decision or other exercises of judgment concerning the merits of the petition.
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In support of its petition, Daimler Vans USA, LLC submitted the following reasoning:
1. There is no safety risk posed with this noncompliance because the tires are designed to carry significantly more than the GAWR listed on the certification label.
2. The Metris vans also have installed the same tire size as the Metris vans sold in Europe that have the same axle weight ratings and those vehicles have performed without incident for years.
3. Despite the discrepancy in calculating the maximum load rating, the Metris vans are more than able to accommodate additional weight loaded onto the vehicle. Per the specifications provided by the tire supplier, based on the tire's load index rating of 101, each tire, in fact, has a maximum load rating of 825 kg (1,818 pounds) per tire and a combined maximum load rating of 1,650 kg (3,637 pounds) per axle. Thus, the tires were designed and manufactured to safely and effectively manage weights that are well beyond the GAWR for each axle.
4. The GAWR listed on the vehicle certification label is accurate so that a consumer relying on and following the values for the front and rear GAWR, for purposes of vehicle loading, would not be at risk of overloading the axles.
5. The tires on the Metris vans have a payload reserve of 6.5 percent at a load of 1,550 kg per axle, which is slightly below the payload reserve of 10 percent specified by FMVSS No. 110. Moreover, the tire pressure specified for each tire on the Metris Van is at least 11% higher (tire pressure reserve) then the ETRTO recommended tire pressure. This tire pressure reserve reduces the stress on the tire, due to reduced deflection of the tire under load.
6. Further, the Metris vans are equipped with a standard tire pressure monitoring system (TPMS) that is compliant with FMVSS No. 138. Depending on the severity of the loss of tire pressure, the Metris vans display one of three specialized TPMS warnings in the instrument panel advising the operator of the loss of pressure and how quickly the operator should take corrective action. If the tires were to experience a loss of tire pressure, the driver would be alerted to this condition and could take appropriate measures. Thus, if there were to be a loss of tire pressure, consistent with the standard, the TPMS system would warn the operator.
7. After identifying the discrepancy in the values listed on the tire and loading information placard, DAG reviewed what, if any, impact there could be on various vehicle systems that could potentially be affected by the discrepancy. This review considered the effect on steering, breaking, axle strength, and crashworthiness if the operator loaded the vehicle to the maximum amount listed on the tire and loading information placard. As a result of the review, DAG was able to confirm that the discrepancy will not adversely impact any of these systems or otherwise diminish the performance or crashworthiness of the Metris vans.
8. DAG is not aware of any consumer complaints or reports of accidents or injuries related to overloading the vehicles that could reasonably be related to not derating the reinforced passenger car tires prior to certification. In addition, Metris vans sold in Europe are equipped with tires that are the same size and the vehicles have the same axle weight ratings. The European vehicles have similarly performed without incident.
9. The agency has previously granted petitions for inconsequential noncompliance involving similar inconsistencies involving tire maximum load ratings. In 2017, the agency granted a petition for inconsequential noncompliance where a manufacturer had incorrectly overstated the maximum occupant and cargo weight on the tire and loading information placard, by a total of 30 kg. Although on its face, this discrepancy would have appeared to have led consumers to potentially overload the vehicle, the agency concluded that when the vehicle was loaded to the value listed on the placard, the specific tires installed on the vehicles were nonetheless technically capable of handling the overstated weight and cargo. In this instance, for one vehicle variation, the maximum loads were below the GAWR and gross vehicle weight rating (GVWR) and for another vehicle variation, the maximum loads were “essentially at the certified GAWR and GVWR values.” The agency concluded that the tires were “more than adequate” to manage the additional vehicle and cargo weight and that the vehicles could safely manage the additional weight without overload concerns.
10. The noncompliance at issue here is similar to the above petition. In this case, there is also little concern of vehicle overloading because the specifications for the tires installed on the Metris vans are technically capable of managing the additional weight even without the reinforced passenger car tires having been derated.
Daimler Vans concluded by expressing the belief that the subject noncompliance is inconsequential as it relates to motor vehicle safety, and that its petition to be exempted from providing notification of the
The Daimler Vans complete petition and all supporting documents are available by logging onto the Federal Docket Management System (FDMS) website at
NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, any decision on this petition only applies to the subject vehicles that Daimler Vans no longer controlled at the time it determined that the noncompliance existed. However, any decision on this petition does not relieve vehicle distributors and dealers of the prohibitions on the sale, offer for sale, or introduction or delivery for introduction into interstate commerce of the noncompliant vehicles under their control after Daimler Vans notified them that the subject noncompliance existed.
49 U.S.C. 30118, 30120: delegations of authority at 49 CFR 1.95 and 501.8.
Office of Foreign Assets Control, Treasury.
Issuance of directive.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) has issued a Russia-Related Directive under Executive Order 13883 of August 1, 2019.
OFAC's action described in this notice was effective on August 26, 2019.
OFAC: Associate Director for Global Targeting, 202-622-2420; Assistant Director for Licensing, 202-622-2480; Assistant Director for Regulatory Affairs, 202-622-4855; or Assistant Director for Sanctions Compliance & Evaluation, 202-622-2490.
On August 6, 2018, the Secretary of State, acting pursuant to delegated authority under section 306(a) of the Chemical and Biological Weapons Control and Warfare Elimination Act of 1991, as amended, 22 U.S.C. 5601
On August 1, 2019, the President, invoking the authority of,
In E.O. 13883, the President directed the Secretary of the Treasury, in consultation with the Secretary of State, to take the following actions when necessary to implement certain sanctions set forth in E.O. 13883 and section 307(b)(2) of the CBW Act selected for imposition on a country by the President or the Secretary of State pursuant to section 307(b)(1) of the CBW Act: (i) Oppose, in accordance with section 701 of the International Financial Institutions Act (22 U.S.C. 262d), the extension of any loan or financial or technical assistance to that country by international financial institutions; and (ii) prohibit any United States bank from making any loan or providing any credit to the government of that country, except for loans or credits for the purpose of purchasing food or other agricultural commodities or products.
Accordingly, on August 2, 2019, pursuant to the Secretary of State's August 2, 2019 decision to impose additional sanctions on Russia, E.O. 13883, and the Weapons of Mass Destruction Proliferators Sanctions Regulations, 31 CFR 544.802, the Director of OFAC issued the Russia-Related Directive Under Executive Order 13883 of August 1, 2019 (CBW Act Directive). OFAC made the CBW Act Directive available on its website on August 3, 2019. OFAC is publishing the CBW Act Directive in the
Pursuant to sections 1(a)(ii), 1(b), and 5 of Executive Order 13883 of August 1, 2019 “Administration of Proliferation Sanctions and Amendment of Executive Order 12851” (the “Order”) and 31 CFR 544.802, and following the Secretary of State's selection of the sanction related to bank loans pursuant to delegated authority under section 307(b) of the Chemical and Biological Weapons Control and Warfare Elimination Act of 1991, as amended (22 U.S.C. 5605(b)), the Director of the Office of Foreign Assets Control has determined, in consultation with the Department of State, that the following activities by a U.S. bank, as defined below, including foreign branches, are prohibited, except to the extent provided by law or unless licensed or otherwise authorized by the Office of Foreign Assets Control: (1) Participation in the primary market for non-ruble denominated bonds issued by the Russian sovereign, as defined below, after August 26, 2019; and (2) lending non-ruble denominated funds to the Russian sovereign, as defined below, after August 26, 2019.
For purposes of this Directive, the term “U.S. bank” means, consistent with the Order and 31 CFR 544.311, any entity organized under the laws of the United States or any jurisdiction within the United States (including its foreign branches), or any entity in the United States, that is engaged in the business of accepting deposits, making, granting, transferring, holding, or brokering loans or credits, or purchasing or selling foreign exchange, securities, commodity futures, or options, or procuring purchasers and sellers thereof, as principal or agent. The term “U.S. bank” includes but is not limited to
Furthermore, for purposes of this Directive, the term “Russian sovereign” means any ministry, agency, or sovereign fund of the Russian Federation, including the Central Bank of Russia, the National Wealth Fund, and the Ministry of Finance of the Russian Federation. This term does not include state-owned enterprises of the Russian Federation.
Except to the extent otherwise provided by law or unless licensed or otherwise authorized by the Office of Foreign Assets Control, the following are also prohibited: (1) Any transaction that evades or avoids, has the purpose of evading or avoiding, causes a violation of, or attempts to violate any of the prohibitions contained in this Directive; and (2) any conspiracy formed to violate any of the prohibitions in this Directive.
Department of Veterans Affairs.
Notice.
Currently, the Department of Veterans Affairs (VA) publishes notices of prospective exclusive, co-exclusive, or partially-exclusive domestic or foreign licenses of Government-owned inventions in the
Dr. John J. Kaplan, Ph.D., J.D., Director, VA Technology Transfer Program (10X2TT), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420; by email at
Pursuant to 37 CFR 404.7(a)(1)(i) and (b)(1)(i), an exclusive, co-exclusive, or partially-exclusive foreign license, may be granted on Government owned inventions only if notice of a prospective license has been published in the
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Robert L. Wilkie, Secretary, Department of Veterans Affairs, approved this document on September 5, 2019, for publication.
In Presidential document 2019-19930 beginning on page 48227 in the issue of Thursday, September 12, 2019, make the following correction:
On page 48227, in the document heading, the word “Secession” should read “Succession”.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing the results of the residual risk and technology reviews (RTR) for the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Lime Manufacturing Plants. We are proposing to find that risks due to emissions of air toxics from this source category are acceptable and that the current NESHAP provides an ample margin of safety to protect public health. Under the technology review, we are proposing to find that there are no developments in practices, processes, or control technologies that necessitate revision of the standards. We are proposing to amend provisions addressing periods of startup, shutdown, and malfunction (SSM) and to add provisions regarding electronic reporting.
You may send comments, identified by Docket ID No. EPA-HQ-OAR-2017-0015, by any of the following methods:
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For questions about this proposed action, contact Jim Eddinger, Sector Policies and Programs Division (D243-01), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-5426; fax number: (919) 541-4991; and email address:
The EPA may publish any comment received to its public docket. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (
The
Table 1 of this preamble lists the NESHAP and associated regulated industrial source category that is the subject of this proposal. Table 1 is not intended to be exhaustive, but rather provides a guide for readers regarding the entities that this proposed action is likely to affect. The proposed standards, once promulgated, will be directly applicable to the affected sources. Federal, state, local, and tribal government entities would not be affected by this proposed action. As defined in the
In addition to being available in the docket, an electronic copy of this action is available on the internet. Following signature by the EPA Administrator, the EPA will post a copy of this proposed action at
A redline version of the regulatory language that incorporates the proposed changes in this action is available in the docket for this action (Docket ID No. EPA-HQ-OAR-2017-0015).
The statutory authority for this action is provided by sections 112 and 301 of the Clean Air Act (CAA), as amended (42 U.S.C. 7401
In the first stage of the CAA section 112 standard setting process, the EPA promulgates technology-based standards under CAA section 112(d) for categories of sources identified as emitting one or more of the HAP listed in CAA section 112(b). Sources of HAP emissions are either major sources or area sources, and CAA section 112 establishes different requirements for major source standards and area source standards. “Major sources” are those that emit or have the potential to emit 10 tons per year (tpy) or more of a single HAP or 25 tpy or more of any combination of HAP. All other sources are “area sources.” For major sources, CAA section 112(d)(2) provides that the technology-based NESHAP must reflect the maximum degree of emission reductions of HAP achievable (after considering cost, energy requirements, and non-air quality health and environmental impacts). These standards are commonly referred to as MACT standards. CAA section 112(d)(3) also establishes a minimum control level for MACT standards, known as the MACT “floor.” The EPA must also consider control options that are more stringent than the floor. Standards more stringent than the floor are commonly referred to as beyond-the-floor standards. In certain instances, as provided in CAA section 112(h), the EPA may set work practice standards where it is not feasible to prescribe or enforce a numerical emission standard. For area sources, CAA section 112(d)(5) gives the EPA discretion to set standards based on generally available control technologies or management practices (GACT standards) in lieu of MACT standards.
The second stage in standard-setting focuses on identifying and addressing any remaining (
The approach incorporated into the CAA and used by the EPA to evaluate residual risk and to develop standards under CAA section 112(f)(2) is a two-step approach. In the first step, the EPA determines whether risks are acceptable. This determination “considers all health information, including risk estimation uncertainty, and includes a presumptive limit on maximum individual lifetime [cancer] risk (MIR)
CAA section 112(d)(6) separately requires the EPA to review standards promulgated under CAA section 112 and revise them “as necessary (taking into account developments in practices, processes, and control technologies)” no less often than every 8 years. In conducting this review, which we call the “technology review,” the EPA is not required to recalculate the MACT floor.
The NESHAP for the Lime Manufacturing source category was promulgated on January 5, 2004 (69 FR 394), and codified at 40 CFR part 63, subpart AAAAA. As promulgated in 2004, the NESHAP regulates HAP emissions from all new and existing lime manufacturing plants that are major sources, co-located with major sources, or are part of major sources. However, lime manufacturing plants located at pulp and paper mills or at beet sugar factories are not subject to the NESHAP. Other captive lime manufacturing plants, such as (but not limited to) those at steel mills and magnesia production facilities, are subject to the NESHAP.
The NESHAP defines the affected source as follows: Each lime kiln and its associated cooler and each individual processed stone handling (PSH) operations system. The PSH operations system includes all equipment associated with PSH operations beginning at the process stone storage bin(s) or open storage pile(s) and ending where the process stone is fed into the kiln. It includes man-made process stone storage bins (but not open process stone storage piles), conveying system transfer points, bulk loading or unloading systems, screening operations, surge bins, bucket elevators, and belt conveyors. The materials processing operations associated with lime products (such as quicklime and hydrated lime), lime kiln dust handling, quarry or mining operations, limestone sizing operations, and fuels are not subject to the NESHAP. Processed stone handling operations are further distinguished in the NESHAP as: (1) Whether their emissions are vented through a stack, (2) whether their emissions are fugitive emissions, (3) whether their emissions are vented through a stack with some fugitive emissions from the partial enclosure, and/or (4) whether the source is enclosed in a building. Finally, lime hydrators and cooler nuisance dust collectors are not included under the definition of affected source under the NESHAP.
The NESHAP established particulate matter (PM) emission limits for lime kilns, coolers, and PSH operations with stacks. Particulate matter is measured solely as a surrogate for the non-volatile and semi-volatile metal HAP. The NESHAP also regulates opacity or visible emissions from most of the PSH operations, with opacity also serving as a surrogate for non-volatile and semi-volatile HAP metals.
The PM emission limit for the existing kilns and coolers is 0.12 pounds PM per ton of stone feed (lb PM/tsf) for kilns using dry air pollution control systems prior to January 5, 2004. Existing kilns that have installed and are operating wet scrubbers prior to January 5, 2004, must meet an emission limit of 0.60 lb PM/tsf. Kilns which meet the criteria for the 0.60 lb PM/tsf emission limit must continue to use a wet scrubber for PM emission control in order to be eligible to meet the 0.60 lb PM/tsf limit. If at any time such a kiln switches to a dry control, they would become subject to the 0.12 lb PM/tsf emission limit, regardless of the type of control device used in the future. The PM emission limit for all new kilns and lime coolers is 0.10 lb PM/tsf. As a compliance option, these emission limits (except for the 0.60 lb PM/tsf limit) may be applied to the combined emissions of all the kilns and coolers at the lime manufacturing plant. If the lime manufacturing plant has both new and existing kilns and coolers, then the emission limit would be an average of the existing and new kiln PM emissions limits, weighted by the annual actual production rates of the individual kilns, except that no new kiln may exceed the PM emission level of 0.10 lb PM/tsf. Kilns that are required to meet a 0.60 lb PM/tsf emission limit must meet that limit individually, and may not be included in any averaging calculations. Emissions from PSH operations that are vented through a stack are subject to a limit of 0.05 grams PM per dry standard cubic meter (g PM/dscm) and 7-percent opacity. Stack emissions from PSH operations that are controlled by wet scrubbers are subject to the 0.05 g PM/
For each building enclosing any PSH operation, each of the affected PSH operations in the building must comply individually with the applicable PM and opacity emission limitations. Otherwise, there must be no visible emissions from the building, except from a vent, and the building's vent emissions must not exceed 0.05 g/dscm and 7-percent opacity. For each fabric filter that controls emissions from only an individual, enclosed processed stone storage bin, the opacity must not exceed 7 percent. For each set of multiple processed stone storage bins with combined stack emissions, emissions must not exceed 0.05 g/dscm and 7-percent opacity. The final rule does not allow averaging of PSH operations.
During the development of 40 CFR part 63, subpart AAAAA, the EPA collected information on the emissions, operations, and location of lime manufacturing plants. Since this information was collected prior to the 2004 promulgation of 40 CFR part 63, subpart AAAAA, the EPA prepared a questionnaire in 2017 in order to collect current information on the location and number of lime kilns, types and quantities of emissions, annual operating hours, types and quantities of fuels burned, and information on air pollution control devices and emission points. Nine companies completed the 2017 questionnaire for which they reported data for 32 of 35 major source facilities. The EPA used data from the 2017 questionnaires to develop the dataset for the NESHAP risk assessment.
The list of facilities that are subject to the NESHAP was developed using the EPA's Enforcement and Compliance History Online (ECHO) database, the 2014 National Emission Inventory (NEI 2014) and the U.S. Geological Survey's (USGS's) Directory of Lime Plants and Hydration Plants in the United States in 2014. The list of facilities, as well as which companies would receive the questionnaire, was reviewed by the industry trade association. The final risk modeling datafile included all 35 major source facilities.
In addition to the ECHO and NEI databases, the EPA reviewed the additional information sources listed below and consulted with stakeholders regulated under the Lime Manufacturing NESHAP to determine whether there have been developments in practices, processes, or control technologies by lime manufacturing sources. These include the following:
• Permit limits and selected compliance options from permits submitted by facilities as part of their response to the questionnaire and collected from state agencies;
• Information on air pollution control options in the lime manufacturing industry from the Reasonably Available Control Technology/Best Available Control Technology/Lowest Achievable Emission Rate Clearinghouse (RBLC); and
• Communication with trade groups and associations representing industries in the affected NAICS categories and their members.
In this section, we describe the analyses performed to support the proposed decisions for the RTR and other issues addressed in this action.
As discussed in section II.A of this preamble and in the Benzene NESHAP, in evaluating and developing standards under CAA section 112(f)(2), we apply a two-step approach to determine whether or not risks are acceptable and to determine if the standards provide an ample margin of safety to protect public health. As explained in the Benzene NESHAP, “the first step judgment on acceptability cannot be reduced to any single factor” and, thus, “[t]he Administrator believes that the acceptability of risk under section 112 is best judged on the basis of a broad set of health risk measures and information.” 54 FR 38046, September 14, 1989. Similarly, with regard to the ample margin of safety determination, “the Agency again considers all of the health risk and other health information considered in the first step. Beyond that information, additional factors relating to the appropriate level of control will also be considered, including cost and economic impacts of controls, technological feasibility, uncertainties, and any other relevant factors.”
The Benzene NESHAP approach provides flexibility regarding factors the EPA may consider in making determinations and how the EPA may weigh those factors for each source category. The EPA conducts a risk assessment that provides estimates of the MIR posed by the HAP emissions from each source in the source category, the hazard index (HI) for chronic exposures to HAP with the potential to cause noncancer health effects, and the hazard quotient (HQ) for acute exposures to HAP with the potential to cause noncancer health effects.
The EPA notes that it has not considered certain health information to date in making residual risk determinations. At this time, we do not attempt to quantify the HAP risk that may be associated with emissions from other facilities that do not include the source category under review, mobile source emissions, natural source emissions, persistent environmental pollution, or atmospheric transformation in the vicinity of the sources in the category.
The EPA understands the potential importance of considering an individual's total exposure to HAP in addition to considering exposure to HAP emissions from the source category and facility. We recognize that such consideration may be particularly important when assessing noncancer risk, where pollutant-specific exposure health reference levels (
In response to the SAB recommendations, the EPA incorporates cumulative risk analyses into its RTR risk assessments, including those reflected in this action. The Agency (1) conducts facility-wide assessments, which include source category emission points, as well as other emission points within the facilities; (2) combines exposures from multiple sources in the same category that could affect the same individuals; and (3) for some persistent and bioaccumulative pollutants, analyzes the ingestion route of exposure. In addition, the RTR risk assessments consider aggregate cancer risk from all carcinogens and aggregated noncancer HQs for all noncarcinogens affecting the same target organ or target organ system.
Although we are interested in placing source category and facility-wide HAP risk in the context of total HAP risk from all sources combined in the vicinity of each source, we are concerned about the uncertainties of doing so. Estimates of total HAP risk from emission sources other than those that we have studied in depth during this RTR review would have significantly greater associated uncertainties than the source category or facility-wide estimates. Such aggregate or cumulative assessments would compound those uncertainties, making the assessments too unreliable.
Our technology review focuses on the identification and evaluation of developments in practices, processes, and control technologies that have occurred since the MACT standards were promulgated. Where we identify such developments, we analyze their technical feasibility, estimated costs, energy implications, and non-air environmental impacts. We also consider the emission reductions associated with applying each development. This analysis informs our decision of whether it is “necessary” to revise the emissions standards. In addition, we consider the appropriateness of applying controls to new sources versus retrofitting existing sources. For this exercise, we consider any of the following to be a “development”:
• Any add-on control technology or other equipment that was not identified and considered during development of the original MACT standards;
• Any improvements in add-on control technology or other equipment (that were identified and considered during development of the original MACT standards) that could result in additional emissions reduction;
• Any work practice or operational procedure that was not identified or considered during development of the original MACT standards;
• Any process change or pollution prevention alternative that could be broadly applied to the industry and that was not identified or considered during development of the original MACT standards; and
• Any significant changes in the cost (including cost effectiveness) of applying controls (including controls the EPA considered during the development of the original MACT standards).
In addition to reviewing the practices, processes, and control technologies that were considered at the time we originally developed the NESHAP, we review a variety of data sources in our investigation of potential practices, processes, or controls to consider. See sections II.C and II.D of this preamble for information on the specific data sources that were reviewed as part of the technology review.
In this section, we provide a complete description of the types of analyses that we generally perform during the risk assessment process. In some cases, we do not perform a specific analysis because it is not relevant. For example, in the absence of emissions of HAP known to be persistent and bioaccumulative in the environment (PB-HAP), we would not perform a multipathway exposure assessment. Where we do not perform an analysis, we state that we do not and provide the reason. While we present all of our risk assessment methods, we only present risk assessment results for the analyses actually conducted (see section IV.B of this preamble).
The EPA conducts a risk assessment that provides estimates of the MIR for cancer posed by the HAP emissions from each source in the source category, the HI for chronic exposures to HAP with the potential to cause noncancer health effects, and the HQ for acute exposures to HAP with the potential to cause noncancer health effects. The assessment also provides estimates of the distribution of cancer risk within the exposed populations, cancer incidence, and an evaluation of the potential for an adverse environmental effect. The seven sections that follow this paragraph
A questionnaire was sent out to nine companies (covering 44 facilities) in 2017. The available test data collected were from the 1990's through 2017. Of the 44 facilities that received the questionnaire, 32 were verified to be major sources and were included in the modeling file. Based on the results of the questionnaire and research into three non-questionnaire facilities, there are 96 lime kilns at the 35 major sources subject to the Lime Manufacturing Plants NESHAP.
Particulate matter test data were provided for most of the lime kilns and the lime kiln and coolers with common exhausts. PM particle size by the kiln emission control type was assigned based on data from AP-42.
Test data for HAP metals were provided for 17 emission release points of lime kilns. Data were provided both for kilns only, and for kilns with co-mingled lime cooler exhaust. Because the data set received was very limited and the emissions were not significantly different, emissions data from stand-alone kilns and shared stacks were treated as similar rather than categorized separately for purposes of estimating emissions. For non-mercury HAP metals, test data were used in conjunction with corresponding PM data to develop mass fractions of HAP metals (
Test data for hydrochloric acid (HCl) were provided for 33 emission release points of lime kilns and kilns/coolers with common exhausts. Organic HAP test data were provided for nine emission release points of kilns/coolers with common exhaust. Dioxins and furans (D/F) test data were provided for five emission release points of both lime kilns and kilns/coolers with common exhausts.
Because the HAP emissions data set received is very limited, emission factors were developed from test data collected from the questionnaire and AEI data. When emissions test data or AEI data were available for an applicable emission unit, the average emission rate of the available data was applied to that applicable emissions unit. In cases where data were unavailable for an applicable emission unit, default emissions values were developed and assigned as needed. Emission defaults were determined as the average of all test or AEI data in each applicable emission unit category (
Due to the nature of the data provided for PM and HAP compounds (
For units that did not provide test result data, default emission rates were developed based on the category of kiln/cooler (new or existing) and the service date of the wet scrubber (before or after January 5, 2004), since these factors align with the PM emission limits of the kiln in the rule. To develop default factors for PM and HCl, the average test results of all single kiln emission units by category/status were determined for each of three default categories: Existing kilns with a wet scrubber installed before January 5, 2004, existing kilns without a wet scrubber installed before January 5, 2004, and new kilns.
Six stand-alone lime coolers were reported through the questionnaire. Of these, four reported PM emissions test data for a total of eleven PM test reports. For these four coolers, emissions were determined as the average of the reported PM test data for each applicable emission unit. The two remaining lime coolers were assigned a default value that was developed as the average of the emissions from the four coolers.
All of the PSH operations were reported as fugitive sources in the questionnaire, with the exception of eleven point source PSH emission units. Very little PM emissions test data were provided for PSH operations, so emissions from these sources were determined from reported 2015 and 2016 AEIs, where available. Emissions values were tallied in units of tpy. Most questionnaire respondents provided AEIs in their responses. However, not all AEIs have PSH emissions reported explicitly, and for those that did, some of the unit names/IDs did not match with those reported in the questionnaire. The questionnaire emission release point IDs were used as the basis for developing PM emissions from AEI data. Emissions data per unit was assigned using AEIs where the unit names matched, averaging the 2015 and 2016 values. Units with no AEI data were assigned the default PM emissions average that was developed from AEI data.
To determine the actual annual emissions of non-mercury HAP metals in tpy from kilns and kiln/coolers with common exhausts, PM emissions were first determined using available test data. Each kiln emissions unit was assigned a PM value based on average actual EPA Method 5 test data for the unit or assigned a default value if PM test data were unavailable. PM
Actual emissions of mercury, HCl, organic HAP, and D/F emissions for kilns and kiln/coolers with common exhausts were based on the test data reported to the questionnaire (in units of lb/hr) multiplied by the reported actual operating hours of each unit. When the emission unit operating hours were unreported or claimed as CBI, a default value (determined as the average of all reported operating hours) was assigned.
Stand-alone lime coolers only emit PM and metal HAP constituents. Most of the lime coolers reported through the questionnaire were annotated as being co-mingled with kiln exhaust, not stand-alone emission units. However, six stand-alone lime coolers were reported to the questionnaire. There were no metal HAP test data provided for stand-alone lime coolers through the questionnaire. As such, one universal set of default metal HAP mass fractions of PM was developed from kiln test data. These defaults were applied to all other PM emission units, including stand-alone coolers. When the rate of stone feed or operating hours were unreported or claimed as CBI, default rates (determined as the average of all reported rates) were assigned.
Process stone handling operations have the potential to emit HAP metals in limestone dust. Eleven PSH units were identified as venting emissions through a stack and the remaining PSH data were modeled as fugitive emissions due to a lack of data in the questionnaire. Operating hours were not specifically reported for PSH operations, so average kiln operating hours were used when reported, otherwise kiln default operating hours were used. Actual emissions were determined using the reported or default PM emissions developed from the AEI multiplied by the HAP speciation.
The available emissions data in the RTR emissions dataset include estimates of the mass of HAP emitted during a specified annual time period. These “actual” emission levels are often lower than the emission levels allowed under the requirements of the current MACT standards. The emissions allowed under the MACT standards are referred to as the “MACT-allowable” emissions. We discussed the consideration of both MACT-allowable and actual emissions in the final Coke Oven Batteries RTR (70 FR 19998-19999, April 15, 2005) and in the proposed and final Hazardous Organic NESHAP RTR (71 FR 34428, June 14, 2006, and 71 FR 76609, December 21, 2006, respectively). In those actions, we noted that assessing the risk at the MACT-allowable level is inherently reasonable since that risk reflects the maximum level facilities could emit and still comply with national emission standards. We also explained that it is reasonable to consider actual emissions, where such data are available, in both steps of the risk analysis, in accordance with the Benzene NESHAP approach. (54 FR 38044, September 14, 1989.)
Allowable HAP metal emissions were calculated by using the existing applicable PM limit, scaled production, and the maximum operating hours per year of 8,760. The hourly production scalar (
Allowable emissions of mercury, HCl, organic HAP, and D/F emissions for kilns and kiln/coolers with common exhausts were calculated using 8,760 hours. Allowable emissions for PSH operations were determined in the same manner as described above for actual emissions, except that emissions were scaled up according to the ratio of total operating hours over actual operating hours.
Both long-term and short-term inhalation exposure concentrations and health risk from the source category addressed in this action were estimated using the Human Exposure Model (HEM-3).
The air dispersion model AERMOD, used by the HEM-3 model, is one of the EPA's preferred models for assessing air pollutant concentrations from industrial facilities.
In developing the risk assessment for chronic exposures, we use the estimated annual average ambient air concentrations of each HAP emitted by
For each facility, we calculate the MIR as the cancer risk associated with a continuous lifetime (24 hours per day, 7 days per week, 52 weeks per year, 70 years) exposure to the maximum concentration at the centroid of each inhabited census block. We calculate individual cancer risk by multiplying the estimated lifetime exposure to the ambient concentration of each HAP (in micrograms per cubic meter (μg/m
To estimate individual lifetime cancer risks associated with exposure to HAP emissions from each facility in the source category, we sum the risks for each of the carcinogenic HAP
To assess the risk of noncancer health effects from chronic exposure to HAP, we calculate either an HQ or a target organ-specific hazard index (TOSHI). We calculate an HQ when a single noncancer HAP is emitted. Where more than one noncancer HAP is emitted, we sum the HQ for each of the HAP that affects a common target organ or target organ system to obtain a TOSHI. The HQ is the estimated exposure divided by the chronic noncancer dose-response value, which is a value selected from one of several sources. The preferred chronic noncancer dose-response value is the EPA RfC, defined as “an estimate (with uncertainty spanning perhaps an order of magnitude) of a continuous inhalation exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a lifetime” (
For each HAP for which appropriate acute inhalation dose-response values are available, the EPA also assesses the potential health risks due to acute exposure. For these assessments, the EPA makes conservative assumptions about emission rates, meteorology, and exposure location. In this proposed rulemaking, as part of our efforts to continually improve our methodologies to evaluate the risks that HAP emitted from categories of industrial sources pose to human health and the environment,
To assess the potential acute risk to the maximally exposed individual, we use the peak hourly emission rate for each emission point,
To characterize the potential health risks associated with estimated acute inhalation exposures to a HAP, we generally use multiple acute dose-response values, including acute RELs, acute exposure guideline levels (AEGLs), and emergency response planning guidelines (ERPG) for 1-hour exposure durations), if available, to calculate acute HQs. The acute HQ is calculated by dividing the estimated acute exposure concentration by the acute dose-response value. For each HAP for which acute dose-response values are available, the EPA calculates acute HQs.
An acute REL is defined as “the concentration level at or below which no adverse health effects are anticipated for a specified exposure duration.”
ERPGs are “developed for emergency planning and are intended as health-based guideline concentrations for single exposures to chemicals.”
An acute REL for 1-hour exposure durations is typically lower than its corresponding AEGL-1 and ERPG-1. Even though their definitions are slightly different, AEGL-1s are often the same as the corresponding ERPG-1s, and AEGL-2s are often equal to ERPG-2s. The maximum HQs from our acute inhalation screening risk assessment typically result when we use the acute REL for a HAP. In cases where the maximum acute HQ exceeds 1, we also report the HQ based on the next highest acute dose-response value (usually the AEGL-1 and/or the ERPG-1).
For this source category, we used the default acute multiplier of 10 to derive a conservative estimate of maximum hourly emissions from annual emissions. In our acute inhalation screening risk assessment, acute impacts are deemed negligible for HAP for which acute HQs are less than or equal to 1, and no further analysis is performed for these HAP. In cases where an acute HQ from the screening step is greater than 1, we assess the site-specific data to ensure we have assessed the acute HQ at an off-site location. For this source category, we did not have to perform any refined acute assessments.
The EPA conducts a tiered screening assessment examining the potential for significant human health risks due to exposures via routes other than inhalation (
For the Lime Manufacturing source category, we identified PB-HAP emissions of arsenic, D/F, cadmium, mercury, and lead, so we proceeded to the next step of the evaluation. Except for lead, the human health risk screening assessment for PB-HAP consists of three progressive tiers. In a Tier 1 screening assessment, we determine whether the magnitude of the facility-specific emissions of PB-HAP warrants further evaluation to characterize human health risk through ingestion exposure. To facilitate this step, we evaluate emissions against previously developed screening threshold emission rates for several PB-HAP that are based on a hypothetical upper-end screening exposure scenario developed for use in conjunction with the EPA's Total Risk Integrated Methodology.Fate, Transport, and Ecological Exposure (TRIM.FaTE) model. The PB-HAP with screening threshold emission rates are arsenic compounds, cadmium compounds, chlorinated dibenzodioxins and furans, mercury compounds, and polycyclic organic matter (POM). Based on the EPA estimates of toxicity and bioaccumulation potential, these pollutants represent a conservative list
We derive the Tier 1 screening threshold emission rates for these PB-HAP (other than lead compounds) to correspond to a maximum excess lifetime cancer risk of 1-in-1 million (
In the Tier 2 screening assessment, the location of each facility that exceeds a Tier 1 screening threshold emission rate is used to refine the assumptions associated with the Tier 1 fisher/farmer scenario. A key assumption in the Tier 1 screening assessment is that a lake and/or farm is located near the facility. As part of the Tier 2 screening assessment, we use a USGS database to identify actual waterbodies within 50 km of each facility and assume the fisher only consumes fish from lakes within that 50 km zone. We also examine the differences between local meteorology near the facility and the meteorology used in the Tier 1 screening assessment. We then adjust the previously-developed Tier 1 screening threshold emission rates for each PB-HAP for each facility based on an understanding of how exposure concentrations estimated for the screening scenario change with the use of local meteorology and the USGS lakes database.
In the Tier 2 farmer scenario, we maintain an assumption that the farm is located within 0.5 km of the facility and that the farmer consumes meat, eggs, dairy, vegetables, and fruit produced near the facility. We may further refine the Tier 2 screening analysis by assessing a gardener scenario to characterize a range of exposures, with the gardener scenario being more plausible in RTR evaluations. Under the gardener scenario, we assume the gardener consumes home-produced eggs, vegetables, and fruit products at the same ingestion rate as the farmer. The Tier 2 screen continues to rely on the high-end food intake assumptions that were applied in Tier 1 for local fish (adult female angler at 99th percentile consumption of fish
There are several analyses that can be included in a Tier 3 screening assessment, depending upon the extent of refinement warranted, including validating that the impacted lakes are fishable, locating residential/garden locations for urban and/or rural settings, considering plume-rise to estimate emissions lost above the mixing layer, and considering hourly effects of meteorology and plume rise on chemical fate and transport (a time-series analysis). If necessary, the EPA may further refine the screening assessment through a site-specific assessment.
In evaluating the potential multipathway risk from emissions of lead compounds, rather than developing a screening threshold emission rate, we compare maximum estimated chronic inhalation exposure concentrations to the level of the current National Ambient Air Quality Standard (NAAQS) for lead.
The EPA conducts a screening assessment to examine the potential for an adverse environmental effect as required under section 112(f)(2)(A) of the CAA. Section 112(a)(7) of the CAA defines “adverse environmental effect” as “any significant and widespread adverse effect, which may reasonably be anticipated, to wildlife, aquatic life, or other natural resources, including adverse impacts on populations of endangered or threatened species or significant degradation of environmental quality over broad areas.”
The EPA focuses on eight HAP, which are referred to as “environmental HAP,” in its screening assessment: Six PB-HAP and two acid gases. The PB-HAP included in the screening assessment are arsenic compounds, cadmium compounds, D/F, POM, mercury (both inorganic mercury and methyl mercury), and lead compounds. The acid gases included in the screening assessment are HCl and hydrogen fluoride (HF).
HAP that persist and bioaccumulate are of particular environmental concern because they accumulate in the soil, sediment, and water. The acid gases, HCl and HF, are included due to their well-documented potential to cause direct damage to terrestrial plants. In the environmental risk screening assessment, we evaluate the following four exposure media: Terrestrial soils, surface water bodies (includes water-column and benthic sediments), fish consumed by wildlife, and air. Within these four exposure media, we evaluate nine ecological assessment endpoints, which are defined by the ecological entity and its attributes. For PB-HAP (other than lead), both community-level and population-level endpoints are included. For acid gases, the ecological assessment evaluated is terrestrial plant communities.
An ecological benchmark represents a concentration of HAP that has been linked to a particular environmental effect level. For each environmental
For further information on how the environmental risk screening assessment was conducted, including a discussion of the risk metrics used, how the environmental HAP were identified, and how the ecological benchmarks were selected, see Appendix 9 of the
For the environmental risk screening assessment, the EPA first determined whether any facilities in the Lime Manufacturing source category emitted any of the environmental HAP. For the Lime Manufacturing source category, we identified emissions of arsenic, D/F, HCl, cadmium, and mercury. Because one or more of the environmental HAP above are emitted by at least one facility in the source category, we proceeded to the second step of the evaluation.
The environmental screening assessment includes six PB-HAP, arsenic compounds, cadmium compounds, D/F, POM, mercury (both inorganic mercury and methyl mercury), and lead compounds. With the exception of lead, the environmental risk screening assessment for PB-HAP consists of three tiers. The first tier of the environmental risk screening assessment uses the same health-protective conceptual model that is used for the Tier 1 human health screening assessment. TRIM.FaTE model simulations were used to back-calculate Tier 1 screening threshold emission rates. The screening threshold emission rates represent the emission rate in tons per year that results in media concentrations at the facility that equal the relevant ecological benchmark. To assess emissions from each facility in the category, the reported emission rate for each PB-HAP was compared to the Tier 1 screening threshold emission rate for that PB-HAP for each assessment endpoint and effect level. If emissions from a facility do not exceed the Tier 1 screening threshold emission rate, the facility “passes” the screening assessment, and, therefore, is not evaluated further under the screening approach. If emissions from a facility exceed the Tier 1 screening threshold emission rate, we evaluate the facility further in Tier 2.
In Tier 2 of the environmental screening assessment, the screening threshold emission rates are adjusted to account for local meteorology and the actual location of lakes in the vicinity of facilities that did not pass the Tier 1 screening assessment. For soils, we evaluate the average soil concentration for all soil parcels within a 7.5-km radius for each facility and PB-HAP. For the water, sediment, and fish tissue concentrations, the highest value for each facility for each pollutant is used. If emission concentrations from a facility do not exceed the Tier 2 screening threshold emission rate, the facility “passes” the screening assessment and typically is not evaluated further. If emissions from a facility exceed the Tier 2 screening threshold emission rate, we evaluate the facility further in Tier 3.
As in the multipathway human health risk assessment, in Tier 3 of the environmental screening assessment, we examine the suitability of the lakes around the facilities to support life and remove those that are not suitable (
To evaluate the potential for an adverse environmental effect from lead, we compared the average modeled air concentrations (from HEM-3) of lead around each facility in the source category to the level of the secondary NAAQS for lead. The secondary lead NAAQS is a reasonable means of evaluating environmental risk because it is set to provide substantial protection against adverse welfare effects which can include “effects on soils, water, crops, vegetation, man-made materials, animals, wildlife, weather, visibility and climate, damage to and deterioration of property, and hazards to transportation, as well as effects on economic values and on personal comfort and well-being.”
The environmental screening assessment for acid gases evaluates the potential phytotoxicity and reduced productivity of plants due to chronic exposure to HF and HCl. The environmental risk screening methodology for acid gases is a single-tier screening assessment that compares modeled ambient air concentrations (from AERMOD) to the ecological benchmarks for each acid gas. To identify a potential adverse environmental effect (as defined in section 112(a)(7) of the CAA) from emissions of HF and HCl, we evaluate the following metrics: the size of the modeled area around each facility that exceeds the ecological benchmark for each acid gas, in acres and km
To put the source category risks in context, we typically examine the risks from the entire “facility,” where the facility includes all HAP-emitting operations within a contiguous area and under common control. In other words, we examine the HAP emissions not only from the source category emission points of interest, but also emissions of HAP from all other emission sources at the facility for which we have data. For this source category, we conducted the facility-wide assessment using a dataset compiled from the 2014 NEI for 31 of the 35 modeled facilities. The remaining four facilities' emissions data were collected using a combination of approaches, including using permit data and substituting emissions data from similar site(s) (refer to Appendix 1 of the
The source category records of the dataset were removed, evaluated, and updated as described in section II.C of this preamble: What data collection activities were conducted to support this action? Once a quality assured source category dataset was available, it was placed back with the remaining records for that facility. The facility-wide file was then used to analyze risks due to the inhalation of HAP that are emitted “facility-wide” for the populations residing within 50 km of each facility, consistent with the methods used for the source category analysis described above. For these facility-wide risk analyses, the modeled source category risks were compared to the facility-wide risks to determine the portion of the facility-wide risks that could be attributed to the source category addressed in this action. We also specifically examined the facility that was associated with the highest estimate of risk and determined the percentage of that risk attributable to the source category of interest. The
For this source category, the majority of the facility-wide dataset that the EPA compiled were from the 2014 NEI. We used the NEI data for the facility and did not adjust any category or “non-category” data. Therefore, there could be differences in the dataset from that used for the source category assessments described in this preamble. We analyzed risks due to the inhalation of HAP that are emitted “facility-wide” for the populations residing within 50 km of each facility, consistent with the methods used for the source category analysis described above. For these facility-wide risk analyses, we made a reasonable attempt to identify the source category risks, and these risks were compared to the facility-wide risks to determine the portion of facility-wide risks that could be attributed to the source category addressed in this action. We also specifically examined the facility that was associated with the highest estimate of risk and determined the percentage of that risk attributable to the source category of interest. The
Uncertainty and the potential for bias are inherent in all risk assessments, including those performed for this proposal. Although uncertainty exists, we believe that our approach, which used conservative tools and assumptions, ensures that our decisions are health and environmentally protective. A brief discussion of the uncertainties in the RTR emissions dataset, dispersion modeling, inhalation exposure estimates, and dose-response relationships follows below. Also included are those uncertainties specific to our acute screening assessments, multipathway screening assessments, and our environmental risk screening assessments. A more thorough discussion of these uncertainties is included in the
Although the development of the RTR emissions dataset involved quality assurance/quality control processes, the accuracy of emissions values will vary depending on the source of the data, the degree to which data are incomplete or missing, the degree to which assumptions made to complete the datasets are accurate, errors in emission estimates, and other factors. The emission estimates considered in this analysis generally are annual totals for certain years, and they do not reflect short-term fluctuations during the course of a year or variations from year to year. The estimates of peak hourly emission rates for the acute effects screening assessment were based on a default emission adjustment factor of 10 applied to the average annual hourly emission rates, which are intended to account for emission fluctuations due to normal facility operations.
We recognize there is uncertainty in ambient concentration estimates associated with any model, including the EPA's recommended regulatory dispersion model, AERMOD. In using a model to estimate ambient pollutant concentrations, the user chooses certain options to apply. For RTR assessments, we select some model options that have the potential to overestimate ambient air concentrations (
Although every effort is made to identify all of the relevant facilities and emission points, as well as to develop accurate estimates of the annual emission rates for all relevant HAP, the uncertainties in our emission inventory likely dominate the uncertainties in the exposure assessment. Some uncertainties in our exposure assessment include human mobility, using the centroid of each census block, assuming lifetime exposure, and assuming only outdoor exposures. For most of these factors, there is neither an under nor overestimate when looking at the maximum individual risk or the incidence, but the shape of the distribution of risks may be affected. With respect to outdoor exposures, actual exposures may not be as high if people spend time indoors, especially for very reactive pollutants or larger particles. For all factors, we reduce uncertainty when possible. For example, with respect to census-block centroids, we analyze large blocks using aerial imagery and adjust locations of the block centroids to better represent
There are uncertainties inherent in the development of the dose-response values used in our risk assessments for cancer effects from chronic exposures and noncancer effects from both chronic and acute exposures. Some uncertainties are generally expressed quantitatively, and others are generally expressed in qualitative terms. We note, as a preface to this discussion, a point on dose-response uncertainty that is stated in the EPA's
Cancer UREs used in our risk assessments are those that have been developed to generally provide an upper bound estimate of risk.
Many of the UFs used to account for variability and uncertainty in the development of acute dose-response values are quite similar to those developed for chronic durations. Additional adjustments are often applied to account for uncertainty in extrapolation from observations at one exposure duration (
Uncertainty also exists in the selection of ecological benchmarks for the environmental risk screening assessment. We established a hierarchy of preferred benchmark sources to allow selection of benchmarks for each environmental HAP at each ecological assessment endpoint. We searched for benchmarks for three effect levels (
Although we make every effort to identify appropriate human health effect dose-response values for all pollutants emitted by the sources in this risk assessment, some HAP emitted by this source category are lacking dose-response assessments. Accordingly, these pollutants cannot be included in the quantitative risk assessment, which could result in quantitative estimates understating HAP risk. To help to alleviate this potential underestimate, where we conclude similarity with a HAP for which a dose-response value is available, we use that value as a surrogate for the assessment of the HAP for which no value is available. To the extent use of surrogates indicates appreciable risk, we may identify a need to increase priority for an IRIS assessment for that substance. We additionally note that, generally speaking, HAP of greatest concern due to environmental exposures and hazard are those for which dose-response assessments have been performed, reducing the likelihood of understating risk. Further, HAP not included in the quantitative assessment are assessed qualitatively and considered in the risk characterization that informs the risk management decisions, including consideration of HAP reductions achieved by various control options.
For a group of compounds that are unspeciated (
In addition to the uncertainties highlighted above, there are several factors specific to the acute exposure assessment that the EPA conducts as part of the risk review under section 112 of the CAA. The accuracy of an acute inhalation exposure assessment depends on the simultaneous occurrence of independent factors that may vary greatly, such as hourly emissions rates, meteorology, and the presence of a person. In the acute screening assessment that we conduct under the RTR program, we assume that peak emissions from the source category and reasonable worst-case air dispersion conditions (
For each source category, we generally rely on site-specific levels of PB-HAP or environmental HAP emissions to determine whether a refined assessment of the impacts from multipathway exposures is necessary or whether it is necessary to perform an environmental screening assessment. This determination is based on the results of a three-tiered screening assessment that relies on the outputs
Model uncertainty concerns whether the model adequately represents the actual processes (
Input uncertainty is concerned with how accurately the models have been configured and parameterized for the assessment at hand. For Tier 1 of the multipathway and environmental screening assessments, we configured the models to avoid underestimating exposure and risk. This was accomplished by selecting upper-end values from nationally representative datasets for the more influential parameters in the environmental model, including selection and spatial configuration of the area of interest, lake location and size, meteorology, surface water, soil characteristics, and structure of the aquatic food web. We also assume an ingestion exposure scenario and values for human exposure factors that represent reasonable maximum exposures.
In Tier 2 of the multipathway and environmental screening assessments, we refine the model inputs to account for meteorological patterns in the vicinity of the facility versus using upper-end national values, and we identify the actual location of lakes near the facility rather than the default lake location that we apply in Tier 1. By refining the screening approach in Tier 2 to account for local geographical and meteorological data, we decrease the likelihood that concentrations in environmental media are overestimated, thereby increasing the usefulness of the screening assessment. In Tier 3 of the screening assessments, we refine the model inputs again to account for hour-by-hour plume rise and the height of the mixing layer. We can also use those hour-by-hour meteorological data in a TRIM.FaTE run using the screening configuration corresponding to the lake location. These refinements produce a more accurate estimate of chemical concentrations in the media of interest, thereby reducing the uncertainty with those estimates. The assumptions and the associated uncertainties regarding the selected ingestion exposure scenario are the same for all three tiers.
For the environmental screening assessment for acid gases, we employ a single-tiered approach. We use the modeled air concentrations and compare those with ecological benchmarks.
For all tiers of the multipathway and environmental screening assessments, our approach to addressing model input uncertainty is generally cautious. We choose model inputs from the upper end of the range of possible values for the influential parameters used in the models, and we assume that the exposed individual exhibits ingestion behavior that would lead to a high total exposure. This approach reduces the likelihood of not identifying high risks for adverse impacts.
Despite the uncertainties, when individual pollutants or facilities do not exceed screening threshold emission rates (
The EPA evaluates the following HAP in the multipathway and/or environmental risk screening assessments, where applicable: Arsenic, cadmium, D/F, lead, mercury (both inorganic and methyl mercury), POM, HCl, and HF. These HAP represent pollutants that can cause adverse impacts either through direct exposure to HAP in the air or through exposure to HAP that are deposited from the air onto soils and surface waters and then through the environment into the food web. These HAP represent those HAP for which we can conduct a meaningful multipathway or environmental screening risk assessment. For other HAP not included in our screening assessments, the model has not been parameterized such that it can be used for that purpose. In some cases, depending on the HAP, we may not have appropriate multipathway models that allow us to predict the concentration of that pollutant. The EPA acknowledges that other HAP beyond these that we are evaluating may have the potential to cause adverse effects and, therefore, the EPA may evaluate other relevant HAP in the future, as modeling science and resources allow.
As described above, for the Lime Manufacturing source category we conducted an inhalation risk assessment for all HAP emitted, a multipathway screening assessment for the PB-HAP emitted, and an environmental risk screening assessment for the PB-HAP and HCl emitted from the source category. We present results of the risk assessment briefly below and in more detail in the the
The EPA estimated inhalation risk based on actual and allowable emissions. The estimated baseline maximum inhalation cancer risk (MIR) posed by the source category is 1-in-1 million based on actual emissions and 2-in-1 million based upon MACT-allowable emissions. The total estimated cancer incidence based on actual emission levels is 0.001 excess cancer cases per year, or one case every 1,000 years. The total estimated cancer incidence based on allowable emission levels is 0.003 excess cancer cases per year, or one case every 333 years. Emissions of metals, aldehydes, and organic HAP from the lime kiln and cooler exhaust accounted for 93 percent to the cancer incidence. The estimated population exposed to cancer risk of 1-in-1 million based upon actual emissions is 12 (see Table 2 of this preamble).
The maximum chronic noncancer TOSHI values for the source category
Based on our screening analysis of reasonable worst-case acute exposure to actual emissions from the category, no HAP exposures result in an HQ greater than 1 (0.6) based upon the 1- hour REL. As discussed in section III.C.3.c of this preamble, we used the default acute hourly multiplier of 10 for all emission processes.
PB-HAP emissions (based on estimates of actual emissions) from all 35 facilities in the source category exceed the Tier 1 screening threshold emission rates for the carcinogenic PB-HAP, D/F, and arsenic. Emissions from 34 of the 35 facilities exceed the Tier 1 screening threshold emission rate for mercury, a PB-HAP with noncancer health effects. Cadmium emissions from all but one facility were below the Tier 1 noncancer screening threshold emission rate. For the PB-HAP and facilities with Tier 1 screening values greater than 1, we conducted a Tier 2 screening analysis.
D/F and arsenic emissions from 26 facilities exceeded the Tier 2 cancer screening value of 1. The Tier 2 fisher scenario resulted in a maximum cancer screening value of 20 with D/F emissions driving the risk. The Tier 2 farmer scenario resulted in a maximum cancer screening value of 20 due to both arsenic and D/F emissions. For cadmium, the Tier 2 noncancer screening value (0.1) did not exceed 1. Mercury emissions from 16 facilities had Tier 2 noncancer screening values greater than 1 under the fisher scenario, with the largest Tier 2 screen value equal to 4. When we evaluated the effect multiple facilities within the source category could have on common lake(s) in the modeling domain, mercury emissions exceeded the noncancer screening value by a factor of 5.
For mercury, we continued the fisher scenario screening analysis with a Tier 3 multipathway screen which comprises three individual stages. These stages included lake, plume rise, and time-series assessments. Tier 3 lake and plume rise assessments weres conducted for all facilities with Tier 2 mercury screening values greater than 1. A Tier 3 time series screen was conducted for the facility with the highest mercury non-cancer screening value after conducting the lake and plume rise assessments. After conducting the time series screen, the facility evaluated had a Tier 3 non-cancer screening value of 2 for mercury, including consideration of cumulative lake impacts from facilities within the source category.
One of the facilities evaluated in the Tier 3 plume-rise screen for mercury also had the highest Tier 2 cancer screening value under the fisher scenario, 20 for D/F. The refined Tier 3 plume rise assessment for this facility resulted in a cancer screening value of 10. This cancer screening value of 10 for the fisher scenario is the highest for the source category. Further details on the Tier 3 screening analysis can be found in Appendix 11 of
A screening value in any of the tiers is not an estimate of the cancer risk or a noncancer HQ (or HI). Rather, a screening value represents a high-end estimate of what the risk or HQ may be. For example, facility emissions resulting in a screening value of 2 for a non-carcinogen can be interpreted to mean that we are confident that the HQ would be lower than 2. Similarly, facility emissions resulting in a cancer screening value of 20 for a carcinogen means that we are confident that the cancer risk is lower than 20-in-1 million. Our confidence comes from the health-protective assumptions that are incorporated into the screens: We choose inputs from the upper end of the range of possible values for the influential parameters used in the screens and we assume food consumption behaviors that would lead to high total exposure. This risk assessment estimates the maximum hazard for mercury through fish consumption based on upper bound screens and the maximum excess cancer risks from D/F and arsenic through ingestion of fish and farm produce.
When we progress from the model designs of the Tier 1, 2, and 3 screens to a site-specific assessment, we refine the risk assessment through incorporation of additional site-specific data and enhanced model designs. Site-specific refinements include the following; (1) improved spatial locations identifying the boundaries of the watershed and lakes within the watershed as they relate to surrounding facilities within the source category; (2) calculating actual soil/water run-off amounts to target lakes based upon actual soil type(s) and elevation changes associated with the affected watershed versus assuming a worst-case
As discussed above, the maximum mercury Tier 2 non-cancer screening value for this source category is 5 with subsequent refinement resulting in a Tier 3 screening value of 2. The EPA has determined that it is not necessary to go beyond the Tier 3 assessment to a site-specific assessment. As explained above, the screening value of 2 is a high-end estimate of what the risk or hazard may be and can be interpreted to mean that we are confident that the HQ would be lower than 2. Further, risk results from three site-specific mercury assessments the EPA has conducted for three RTR source categories resulted in noncancer HQs that were at least 50 times lower than the respective Tier 2 screening value for these facilities (refer to EPA Docket ID No.: 2017-HQ-OAR-2017-0015 for a copy of these reports).
In evaluating the potential for multipathway effects from emissions of lead, the EPA compared modeled annual lead concentrations to the secondary NAAQS level for lead (0.15 μg/m
As described in section III.A of this preamble, we conducted an environmental risk screening assessment for the Lime Manufacturing source category for the following pollutants: arsenic, cadmium, D/F, HCl, hydrofluoric acid, lead, mercury (methyl mercury and mercuric chloride), and POM.
In the Tier 1 screening analysis for PB-HAP (other than lead, which was evaluated differently), arsenic, cadmium, and POM emissions had no exceedances of any of the ecological benchmarks evaluated. D/F emissions had a Tier 1 exceedance at 31 facilities for a surface soil no-observed-adverse-effect-level (NOAEL) (mammalian insectivores—shrew) by a maximum screening value of 30. Divalent mercury emissions had Tier 1 exceedances for the following benchmarks: Sediment threshold level (one facility), surface soil threshold level—plant communities (25 facilities), and surface soil threshold level—invertebrate communities (32 facilities) by a maximum screening value of 20. Methyl mercury emissions had Tier 1 exceedances for the following benchmarks: Fish (avian/piscivores) NOAEL—Merganser (one facility), surface soil NOAEL for mammalian insectivores—shrew (13 facilities), and surface soil NOAEL for avian ground insectivores—woodcock (33 facilities) by a maximum screening value of 40.
A Tier 2 screening analysis was performed for D/F, divalent mercury, and methyl mercury emissions. In the Tier 2 screening analysis, there were no exceedances of any of the ecological benchmarks evaluated for any of the pollutants.
For lead, we did not estimate any exceedances of the secondary lead NAAQS. For HCl and HF, the average modeled concentration around each facility (
Based on the results of the environmental risk screening analysis, we do not expect an adverse environmental effect as a result of HAP emissions from this source category.
The maximum lifetime individual cancer risk posed by the 35 facilities, based on facility-wide emissions, is 1-in-1 million (estimated for three facilities), with arsenic, chromium (VI) compounds, and nickel emissions from fugitive PSH operations driving the risk. The total estimated cancer incidence from facility-wide emissions is 0.004 excess cancer cases per year, or one case in every 250 years. Approximately 30 people are estimated to have cancer risk equal to 1-in-1 million from facility-wide emissions. The maximum facility-wide chronic noncancer TOSHI is estimated to be less than 1 (0.4), mainly driven by emissions of HCl from a facility-wide fugitive area source.
To examine the potential for any environmental justice issues that might be associated with the source category, we performed a demographic analysis, which is an assessment of risk to individual demographic groups of the populations living within 5 km and within 50 km of the facilities. In the analysis, we evaluated the distribution of HAP-related cancer and noncancer risk from the Lime Manufacturing source category across different demographic groups within the populations living near facilities.
The results of the demographic analysis are summarized in Table 3 below. These results, for various demographic groups, are based on the estimated risk from actual emissions levels for the population living within 50 km of the facilities.
The results of the Lime Manufacturing source category demographic analysis indicate that emissions from the source category expose approximately 12 people to a cancer risk at or above 1-in-1 million and no people to a chronic noncancer TOSHI greater than 1. The percentages of the at-risk population indicate that three of the 10 demographic groups (White, African American and people below the poverty level) that are living within 50 km of facilities in the source category exceed the corresponding national percentage for the same demographic groups.
The methodology and the results of the demographic analysis are presented in a technical report,
As explained in section II.A of this preamble, the EPA sets standards under CAA section 112(f)(2) using “a two-step standard-setting approach, with an analytical first step to determine an ‘acceptable risk' that considers all health information, including risk estimation uncertainty, and includes a presumptive limit on MIR of approximately 1-in-10 thousand” (54 FR 38045, September 14, 1989). The EPA weighed all health risk measures and information, including science policy assumptions and estimation uncertainties, in determining whether risk posed by emissions from the source category is acceptable.
The maximum cancer risk for inhalation exposure to actual emissions from the Lime Manufacturing source category (1-in-1 million) is two orders of magnitude below 100-in-1 million, which is the presumptive upper limit of acceptable risk. The maximum inhalation cancer risk based on MACT allowable emissions (2-in-1 million) is similar. The EPA estimates emissions from the category would result in a cancer incidence of 0.001 excess cancer cases per year, or one case every 1,000 years. Twelve individuals are estimated to have inhalation cancer risk equal to 1-in-1 million. Inhalation exposures to HAP associated with chronic noncancer health effects result in a TOSHI of 0.04 based on actual emissions, 25 times below an exposure that the EPA has estimated is without appreciable risk of adverse health effects. Exposures to HAP associated with acute noncancer health effects also are below levels of health concern with no HAP exposures resulting in an HQ greater than 1 (0.6) based upon the 1-hour REL.
Maximum cancer risk due to ingestion exposures estimated using health-protective risk screening assumptions are below 10-in-1 million for the Tier 3 fisher scenario and below 20-in-1 million for the Tier 2 farmer exposure scenario. The Tier 3 noncancer screening analyses of mercury exposure due to fish ingestion determined that the maximum HQ for mercury would be less than 2, as explained in section III.C.4 of this preamble. The EPA is confident that this hazard estimate would be reduced to a HQ of less than 1 if further refined to incorporate enhanced site-specific analyses such as improved model boundary identification with improved soil/water run-off calculations and AERMOD deposition outputs used in the TRIM.FaTE model. Considering all of the health risk information and factors discussed above, as well as the uncertainties discussed in section III of this preamble, we propose that the risks posed by emissions from the Lime
As directed by CAA section 112(f)(2), we conducted an analysis to determine whether the current emissions standards provide an ample margin of safety to protect public health. Under the ample margin of safety analysis, we evaluated the cost and feasibility of available control technologies and other measures (including the controls, measures, and costs reviewed under the technology review) that could be applied to this source category to further reduce the risks (or potential risks) due to emissions of HAP from the source category. In this analysis, we considered the results of the technology review, risk assessment, and other aspects of our MACT rule review to determine whether there are any measures that would reduce risk further.
Although we are proposing that the risks from this source category are acceptable, risk estimates for approximately 12 people in the exposed population are equal to 1-in-1 million, caused by chromium (VI) compounds, arsenic, nickel, and cadmium emissions (see Table 2 of this preamble). Lime kiln and cooler exhaust emissions result in 93 percent of the cancer incidence for this source category. The NESHAP controls PM as a surrogate for non-mercury HAP metals. Our technology review did not identify any practices, controls, or process options that are being used in this industry that would result in further reduction of PM emissions.
For D/F and mercury emissions, activated carbon injection (ACI) systems installed prior to the PM control device were identified as a potential control technology. We found that ACI systems have been used on municipal waste combustors, medical waste incinerators, and cement kilns. Experience with ACI on municipal waste combustors and medical waste incinerators led the EPA to develop emission limits for D/F emissions for these sources in the range of 0.26 to 2.5 nanograms as toxic equivalents per dry standard cubic meter (ng TEQ/dscm). These D/F emission levels are well above the D/F emission levels (0.008 to 0.0148 ng TEQ/dscm) that have been measured from lime kilns. Total annual costs for an ACI system, installed prior to the existing PM control device, are estimated to be $137,000 per lime kiln. Based on the cost and considering the potential negligible reduction of the already low measured D/F emissions, we do not consider the use of ACI systems to be cost effective for the industry to further reduce D/F emissions. The use of ACI systems would have little effect on the source category risks.
As for mercury emissions, ACI is used on cement kilns which are similar to lime kilns in design, fuel combusted, and feed material. In the RTR conducted for the portland cement manufacturing industry, we estimated that for a typical cement kiln that the addition of an ACI system would result in a 2.3 to 3.0 lb per year reduction in mercury (see 82 FR 44277). Assuming a similar reduction in mercury emissions would be achieved for a typical lime kiln, the cost effectiveness of an ACI system installed prior to the PM control device would be $46,000 to $60,000 per lb of mercury removed. Thus, we do not consider the use of ACI systems to be cost effective for the industry to use to further reduce mercury emissions. Our risk analysis indicated the noncancer risks from mercury are low and any further risk reduction from the use of ACI would be minimal.
Because no additional cost-effective measures were identified to further reduce HAP risk from affected sources in the Lime Manufacturing source category, we are proposing that the current NESHAP provides an ample margin of safety to protect public health.
Based on the results of our environmental risk screening, we do not anticipate an adverse environmental effect as a result of HAP emissions from this source category and we are proposing that it is not necessary to set a more stringent standard to prevent, taking into consideration costs, energy, safety, and other relevant factors, an adverse environmental effect.
The RBLC provides several options for searching the permit database on-line to locate applicable control technologies. We searched the RBLC database for RBL determinations made during the time period between this NESHAP promulgation date (January 05, 2004) and the date the RBLC search was conducted (August 27, 2018). Search results showed a total of 17 facilities with RBL determinations during the 2004-2018 time frame. These results were reviewed to identify any developments in practices, processes, or control technologies related to reducing emissions of PM from lime kilns and PSH operations.
The primary controls identified were the use of fabric filters to control PM emissions from stacks and the use of water (wet suppression) for the control of PM emissions from fugitive PSH operations. These methods of control served as the basis for standards promulgated in the original NESHAP. The results of the RBLC search did not identify developments in practices, processes, or control technologies for the Lime Manufacturing source category under CAA section 112(d)(6).
To identify developments in emission control strategies, the following questions were asked as part of the January 2017 ICR:
• Do you use any alternative control devices (
• Do you have any plans to install any new higher efficiency rated control devices or have any pending applications to add on any new controls?
• Describe any procedures you use at your facility to prevent pollution (as opposed to controlling pollution after it is formed).
• Have you implemented any work practice standards or standard operating procedures that will further reduce HAP emissions?
The responses to this inquiry did not identify any developments in practices, processes, or control technologies that would warrant revision to the existing emission standards for the Lime Manufacturing source category.
This review did not identify any developments in practices, processes, or control technologies for PM that have been implemented in this source category since promulgation of the current NESHAP in January of 2004. Consequently, we propose that no revisions to the NESHAP are necessary pursuant to CAA section 112(d)(6). For a detailed discussion of the findings, refer to the
In addition to the proposed actions described above, we are proposing additional revisions to the NESHAP. We are proposing revisions to the SSM provisions of the MACT rule in order to ensure that they are consistent with the Court decision in
In its 2008 decision in
We are proposing the elimination of the SSM exemption in this rule, which appears at 40 CFR 63.7100 and in Table 8 to subpart AAAAA of part 63. Consistent with
The EPA has attempted to ensure that the provisions we are proposing to eliminate are inappropriate, unnecessary, or redundant in the absence of the SSM exemption. We are specifically seeking comment on whether we have successfully done so. The EPA believes the removal of the SSM exemption creates no additional burden to facilities regulated under the Lime Manufacturing Plants NESHAP. Deviations currently addressed by a facility's SSM plan are required to be reported in the Semiannual Compliance Report, a requirement that remains under the proposal (40 CFR 63.7130). Facilities will no longer need to develop an SSM plan or keep it current (Table 8, 40 CFR part 63, subpart AAAAA).
In proposing the standards in this rule, the EPA has taken into account startup and shutdown periods and, for the reasons explained below, is proposing alternate standards for those periods.
The EPA has made the determination under CAA section 112(h) that for kilns and coolers it is not feasible to prescribe or enforce a numeric standard during periods of startup and shutdown because the application of measurement methodology is impracticable due to technological and economic limitations. The test methods required for demonstrating compliance are required to be conducted under isokinetic conditions (
The EPA is proposing to require sources to vent emissions to the main stack and operate all control devices necessary to meet the normal operating limits under this NESHAP (with the exception of ESPs) when firing fuel in the lime kiln during startup and shutdown. We are proposing that startup ends 1 hour after lime is produced from the kiln.
Stakeholders in several source categories have expressed concerns that the requirement for engaging applicable control devices does not accommodate potential safety problems associated with ESP operation. Recommended manufacturer operating procedures provided to the EPA during rulemaking for the Industrial, Commercial, and Institutional Boilers and Process Heaters NESHAP explained the potential hazards associated with ESP energization when unburned fuel may exist in the presence of oxygen levels high enough that the mixture can be in the flammable range. In addition, the stakeholders claim that the ESP cannot practically be engaged until a certain flue gas temperature is reached. Specifically, they claim that premature starting of this equipment will lead to short-term stability problems that could result in unsafe operations and longer term degradation of ESP performance due to fouling, increased chances of wire damage, or increased corrosion within the chambers. They also state that vendors providing this equipment incorporate these safety and operational concerns into their standard operating procedures. For example, they claim that some ESPs have oxygen sensors and alarms that shut down the ESP at high flue gas oxygen levels to avoid a fire in the unit. The oxygen level is typically high during startup, so the ESP may not engage due to these safety controls until more stable operating conditions are reached. These stakeholder claims are supported by a guidance document
In order to clarify that the work practice does not supersede any other standard or requirements to which the affected source is subject, the EPA is including in the proposed alternate work practice provision a requirement that control devices operate when necessary to comply with other standards (
In addition, to ensure compliance with the proposed definition of startup and the work practice standard that applies during startup periods, we are proposing that certain events and parameters be monitored and recorded during the startup periods. These events include the time when firing (
We request comments on the proposed startup and shutdown provisions (definitions and work practices).
Periods of startup, normal operations, and shutdown are all predictable and routine aspects of a source's operations. Malfunctions, in contrast, are neither predictable nor routine. Instead they are, by definition, sudden, infrequent, and not reasonably preventable failures of emissions control, process, or monitoring equipment. (40 CFR 63.2, definition of malfunction). The EPA interprets CAA section 112 as not requiring emissions that occur during periods of malfunction to be factored into development of CAA section 112 standards and this reading has been upheld as reasonable by the Court in
As the Court recognized in
Although no statutory language compels the EPA to set standards for malfunctions, the EPA has the discretion to do so where feasible. For example, in the Petroleum Refinery Sector RTR, the EPA established a work practice standard for unique types of malfunction that result in releases from pressure relief devices or emergency flaring events because information was available to determine that such work practices reflected the level of control that applies to the best performers (80 FR 75178, 75211-14; December 1, 2015). The EPA will consider whether circumstances warrant setting standards for a particular type of malfunction and, if so, whether the EPA has sufficient information to identify the relevant best performing sources and establish a standard for such malfunctions. We also encourage commenters to provide any such information.
In the event that a source fails to comply with the applicable CAA section 112(d) standards as a result of a malfunction event, the EPA would determine an appropriate response based on, among other things, the good faith efforts of the source to minimize emissions during malfunction periods, including preventative and corrective actions, as well as root cause analyses to ascertain and rectify excess emissions. The EPA would also consider whether the source's failure to comply with the CAA section 112(d) standard was, in fact, sudden, infrequent, not reasonably preventable and was not instead caused in part by poor maintenance or careless operation. 40 CFR 63.2 (definition of malfunction).
If the EPA determines in a particular case that an enforcement action against a source for violation of an emission standard is warranted, the source can raise any and all defenses in that enforcement action and the federal district court will determine what, if any, relief is appropriate. The same is true for citizen enforcement actions. Similarly, the presiding officer in an administrative proceeding can consider any defense raised and determine whether administrative penalties are appropriate.
In summary, the EPA interpretation of the CAA and, in particular, CAA section 112, is reasonable and encourages practices that will avoid malfunctions. Administrative and judicial procedures for addressing exceedances of the standards fully recognize that violations may occur despite good faith efforts to comply and can accommodate those situations.
We are proposing to revise the General Provisions table (Table 8) entry
We are also proposing to revise Table 8 to add an entry for 40 CFR 63.6(e)(1)(ii) and include a “no” in column 3. Section 63.6(e)(1)(ii) imposes requirements that are not necessary with the elimination of the SSM exemption or are redundant with the general duty requirement being added at 40 CFR 63.7100.
We are also proposing to revise Table 8 to add an entry for 40 CFR 63.6(e)(1)(iii) and include a “yes” in column 3.
Finally, we are proposing to revise Table 8 to remove an entry for 40 CFR 63.6(e)(2) because this paragraph is reserved and is not applicable to 40 CFR part 63, subpart AAAAA.
We are proposing to revise Table 8 for 40 CFR 63.6(e)(3) and include a “no” in column 3. Generally, these paragraphs require development of an SSM plan and specify SSM recordkeeping and reporting requirements related to the SSM plan. As noted, the EPA is proposing to remove the SSM exemptions. Therefore, affected units will be subject to an emission standard during such events. The applicability of a standard during such events will ensure that sources have ample incentive to plan for and achieve compliance and, thus, the SSM plan requirements are no longer necessary.
We are proposing to revise Table 8 entry for 40 CFR 63.6(f)(1)-(3) by redesignating it as 40 CFR 63.6(f)(2)-(3) and adding an entry for 40 CFR 63.6(f)(1) and including a “no” in column 3. The current language of 40 CFR 63.6(f)(1) exempts sources from non-opacity standards during periods of SSM. As discussed above, the Court in
We are proposing to revise Table 8 entry for 40 CFR 63.6(h)(1)-(2) by redesignating it as 40 CFR 63.6(h)(2) and adding an entry for 40 CFR 63.6(h)(1) and including a “no” in column 3. The current language of 40 CFR 93.6(h)(1) exempts sources from opacity standards during periods of SSM. As discussed above, the Court in
We are proposing to revise Table 8 entry for 40 CFR 63.7(e)(1)-(4) by redesignating it as 40 CFR 63.7(e)(2)-(4) and adding an entry for 40 CFR 63.7(e)(1) and including a “no” in column 3. Section 63.7(e)(1) describes performance testing requirements. The EPA is instead proposing to revise the performance testing requirement at 40 CFR 63.7112 to remove the language “according to the requirements in § 63.7(e)(1)” because 40 CFR 63.7(e)(1) restated the SSM exemption. 40 CFR 63.7112(c) of the current rule specifies that performance testing must not be conducted during periods of SSM. Section 63.7112(b) also specifies that the performance test be conducted under the specific conditions specified in Table 4 to this subpart. Operations during periods of SSM, and during periods of nonoperation do not constitute representative operating conditions. The current language in 40 CFR 63.7112(h) requires the owner or operator to record the process information that is necessary to document operating conditions during the test and the EPA is proposing to add language that requires the owner and operator to include in such record an explanation to support that such conditions represent normal operation. Section 63.7(e) requires that the owner or operator make available to the Administrator such records “as may be necessary to determine the condition of the performance test” available to the Administrator upon request but does not specifically require the information to be recorded. The regulatory text in the current rule already makes explicit the requirement to record the information.
We are proposing to revise Table 8 entry for 40 CFR 63.8(c)(1)-(3) by redesignating it as 40 CFR 63.8(c)(2)-(3) and adding entries for 40 CFR 63.8(c)(1)(i) and 40 CFR 63.8(c)(1)(iii) and including a “no” in column 3. The cross-references to the general duty and SSM plan requirements in those subparagraphs are not necessary considering other requirements of 40 CFR 63.8 that require good air pollution control practices (40 CFR 63.8(c)(1)) and that set out the requirements of a quality control program for monitoring equipment (40 CFR 63.8(d)).
We are proposing to revise the Table 8 entry for 40 CFR 63.10(b)(1)-(b)(2)(xii) by redesignating it as 40 CFR 63.10(b)(1) and adding an entry for 40 CFR 63.10(b)(2)(i) and including a “no” in column 3. Section 63.10(b)(2)(i) describes the recordkeeping requirements during startup and shutdown. We are instead proposing to add recordkeeping requirements to 40 CFR 63.7132. When a source is subject to a different standard during startup and shutdown, it will be important to know when such startup and shutdown periods begin and end in order to determine compliance with the appropriate standard. Thus, the EPA is proposing language in 40 CFR 63.7132 requiring that sources subject to an emission standard during startup or shutdown that differs from the emission standard that applies at all other times must report the date, time, and duration of such periods.
We are proposing to revise Table 8 to add an entry for 40 CFR 63.10(b)(2)(ii) and include a “no” in column 3. Section 63.10(b)(2)(ii) describes the recordkeeping requirements during a malfunction. A similar record is already required in 40 CFR 63.7131(d) and (e). The regulatory text in 40 CFR 63.7131(d) and (e) differs from the General Provisions in that the General Provisions requires the creation and retention of a record of the occurrence and duration of each malfunction of process, air pollution control, and monitoring equipment; whereas 40 CFR 63.7131(d) and (e) applies to any failure to meet an applicable standard and is requiring that the source record the date, time, and duration of the failure rather than the “occurrence.” The EPA is also proposing to add to 40 CFR 63.7132 a requirement that sources keep records that include a list of the affected
We are proposing to revise Table 8 by adding an entry for 40 CFR 63.10(b)(2)(iv) and including a “no” in column 3. When applicable, the provision requires sources to record actions taken during SSM events when actions were inconsistent with their SSM plan. The requirement is no longer appropriate because SSM plans will no longer be required. The requirement previously applicable under 40 CFR 63.10(b)(2)(iv)(B) to record actions to minimize emissions and record corrective actions is now applicable by reference to 40 CFR 63.7132.
We are proposing to revise Table 8 by adding an entry for 40 CFR 63.10(b)(2)(v) and including a “no” in column 3. When applicable, the provision requires sources to record actions taken during SSM events to show that actions taken were consistent with their SSM plan. The requirement is no longer appropriate because SSM plans will no longer be required.
We are proposing to revise the Table 8 entry for 40 CFR 63.10(d)(5) by changing the “yes” in column 3 to a “no.” Section 63.10(d)(5) describes the reporting requirements for startups, shutdowns, and malfunctions. To replace the General Provisions reporting requirement, the EPA is proposing to add reporting requirements to 40 CFR 63.7131. The replacement language differs from the General Provisions requirement in that it eliminates periodic SSM reports as a stand-alone report. We are proposing language that requires sources that fail to meet an applicable standard at any time to report the information concerning such events in the semi-annual compliance report already required under this rule. We are proposing that the report must also contain the number, date, time, duration, and the cause of such events (including unknown cause, if applicable), a list of the affected source or equipment, an estimate of the quantity of each regulated pollutant emitted over any emission limit, and a description of the method used to estimate the emissions.
Examples of such methods would include product-loss calculations, mass balance calculations, measurements when available, or engineering judgment based on known process parameters. The EPA is proposing this requirement to ensure that there is adequate information to determine compliance, to allow the EPA to determine the severity of the failure to meet an applicable standard, and to provide data that may document how the source met the general duty to minimize emissions during a failure to meet an applicable standard.
We will no longer require owners or operators to determine whether actions taken to correct a malfunction are consistent with an SSM plan, because plans would no longer be required. The proposed amendments, therefore, eliminate the cross-reference to 40 CFR 63.10(d)(5)(i) that contains the description of the previously required SSM report format and submittal schedule from this section. These specifications are no longer necessary because the events will be reported in otherwise required reports with similar format and submittal requirements. Section 63.10(d)(5)(ii) describes an immediate report for startups, shutdowns, and malfunctions when a source failed to meet an applicable standard but did not follow the SSM plan. We will no longer require owners and operators to report when actions taken during a startup, shutdown, or malfunction were not consistent with an SSM plan because plans would no longer be required.
Through this proposal, the EPA is proposing that beginning 180 days after publication of the final rule in the
For compliance reports, the proposed rule requires that owners and operators use the appropriate spreadsheet template to submit information to CEDRI beginning 181 days after publication of the final rule in the
Additionally, the EPA has identified two broad circumstances in which electronic reporting extensions may be provided. In both circumstances, the decision to accept the claim of needing additional time to report is within the discretion of the Administrator, and reporting should occur as soon as possible. The EPA is providing these potential extensions to protect owners and operators from noncompliance in cases where they cannot successfully submit a report by the reporting deadline for reasons outside of their control. The first situation in which an extension may be warranted is due to outages of the EPA's CDX or CEDRI that precludes an owner or operator from accessing the system and submitting required reports is addressed in 40 CFR 63.8693(h). The second situation is due to a force majeure event, which is defined as an event that will be or has been caused by circumstances beyond the control of the affected facility, its contractors, or any entity controlled by the affected facility that prevents an owner or operator from complying with the requirement to submit a report electronically as required by this rule is addressed in 40 CFR 63.8693(i). Examples of such events are acts of nature, acts of war or terrorism, or
The electronic submittal of the reports addressed in this proposed rulemaking will increase the usefulness of the data contained in those reports, is in keeping with current trends in data availability and transparency, will further assist in the protection of public health and the environment, will improve compliance by facilitating the ability of regulated facilities to demonstrate compliance with requirements, and by facilitating the ability of delegated state, local, tribal, and territorial air agencies and the EPA to assess and determine compliance, and will ultimately reduce burden on regulated facilities, delegated air agencies, and the EPA. Electronic reporting also eliminates paper-based, manual processes, thereby saving time and resources, simplifying data entry, eliminating redundancies, minimizing data reporting errors, and providing data quickly and accurately to the affected facilities, air agencies, the EPA, and the public. Moreover, electronic reporting is consistent with the EPA's plan
The following are additional proposed changes that address technical and editorial corrections:
• Revising the monitoring requirements in 40 CFR 63.7113 to the provision that triboelectric bag leak detection system must be installed, calibrated, operated, and maintained according to EPA-454/R-98-015.
• Revising 40 CFR 63.7142 to add an alternative test method to EPA Method 320;
• Revising 40 CFR.7142 to add the latest version of ASTM Method D6735-01;
• Revising 40 CFR.7142 to add the latest version of ASTM Method D6420-99; and
• Revising Table 4 to 40 CFR part 63, subpart AAAAA, to add alternative compliance option.
The EPA is proposing that existing affected sources must comply with the amendments in this rulemaking no later than 180 days after the effective date of the final rule. The EPA is also proposing that affected sources that commence construction or reconstruction after September 16, 2019 must comply with all requirements of the subpart, including the amendments being proposed, no later than the effective date of the final rule or upon startup, whichever is later. All affected existing facilities would have to continue to meet the current requirements of 40 CFR part 63, subpart AAAAA, until the applicable compliance date of the amended rule. The final action is not expected to be a “major rule” as defined by 5 U.S.C. 804(2), therefore, the effective date of the final rule will be the promulgation date as specified in CAA section 112(d)(10). For existing affected sources, we are proposing two changes that would impact ongoing compliance requirements for 40 CFR part 63, subpart AAAAA. As discussed elsewhere in this preamble, we are proposing to add a requirement that notifications, performance test results, and the semiannual reports using the new template be submitted electronically. We are also proposing to change the requirements for SSM by removing the exemption from the requirements to meet the standard during SSM periods and by removing the requirement to develop and implement an SSM plan. Our experience with similar industries that have been required to convert reporting mechanisms, install necessary hardware, install necessary software, become familiar with the process of submitting performance test results electronically through the EPA's CEDRI, test these new electronic submission capabilities, reliably employ electronic reporting, and convert logistics of reporting processes to different time-reporting parameters shows that a time period of a minimum of 90 days, and more typically, 180 days, is generally necessary to successfully complete these changes. Our experience with similar industries further shows that this sort of regulated facility generally requires a time period of 180 days to read and understand the amended rule requirements; evaluate their operations to ensure that they can meet the standards during periods of startup and shutdown as defined in the rule and make any necessary adjustments; adjust parameter monitoring and recording systems to accommodate revisions; and update their operations to reflect the revised requirements. The EPA recognizes the confusion that multiple different compliance dates for individual requirements would create and the additional burden such an assortment of dates would impose. From our assessment of the time frame needed for compliance with the entirety of the revised requirements, the EPA considers a period of 180 days to be the most expeditious compliance period practicable, and, thus, is proposing that existing affected sources be in compliance with all of this regulation's revised requirements within 180 days of the regulation's effective date. We solicit comment on this proposed compliance period, and we specifically request submission of information from sources in this source category regarding specific actions that would need to be undertaken to comply with the proposed amended requirements and the time needed to make the adjustments for compliance with any of the revised requirements. We note that information provided may result in changes to the proposed compliance date.
There are currently 35 lime manufacturing facilities operating in the United States that are subject to the Lime Manufacturing Plants NESHAP. The 40 CFR part 63, subpart AAAAA, affected source is the lime kiln and its associated cooler, and the PSH operation system located at a major source of HAP emissions. A new or reconstructed affected source is a source that commenced construction after December 20, 2002, or meets the definition of reconstruction and commenced reconstruction after December 20, 2002.
At the current level of control, emissions of total HAP are estimated to be approximately 2,320 tpy in 2019. This represents a reduction in HAP emissions of about 240 tpy due to the current (2004) Lime Manufacturing Plants NESHAP. The proposed amendments will require all affected
Indirect or secondary air emissions impacts are impacts that would result from the increased electricity usage associated with the operation of control devices (
The 35 lime manufacturing plants that would be subject to the proposed amendments would incur minimal net costs to meet revised recordkeeping and reporting requirements and the proposed work practice standards for periods of startup and shutdown. Nationwide costs associated with the proposed requirements are estimated to be $14,355 following promulgation of the amendments. The EPA believes that the lime manufacturing plants which are subject to the NESHAP can meet the proposed requirements with minimal additional capital or operational costs. For further information on the requirements being proposed, see section IV of this preamble. Each facility will experience costs to read and understand the rule amendments. Costs associated with the elimination of the SSM exemption were estimated as part of the reporting and recordkeeping costs and include time for re-evaluating previously developed SSM record systems. Costs associated with the requirement to electronically submit notifications and semi-annual compliance reports using CEDRI were estimated as part of the reporting and recordkeeping costs and include time for becoming familiar with CEDRI and the reporting template for semi-annual compliance reports. We solicit comment on these estimated cost impacts.
Economic impact analyses focus on changes in market prices and output levels. If changes in market prices and output levels in the primary markets are significant enough, impacts on other markets may also be examined. Both the magnitude of costs needed to comply with a proposed rule and the distribution of these costs among affected facilities can have a role in determining how the market will change in response to a proposed rule. The total costs associated with reviewing the final rule, meeting the revised recordkeeping and reporting requirements, and complying with the proposed work practice standards are estimated to be $14,355 following promulgation of the final rule. This is an estimated cost of $250 to $2750 per facility, depending on the number of lime kilns operated and the type of controls installed. These costs are not expected to result in a significant market impact, regardless of whether they are passed on to the purchaser or absorbed by the firms. Based on the costs associated with the elimination of the SSM exemption and the costs associated with the requirement to electronically submit compliance reports, we do not anticipate any significant economic impacts from these proposed amendments.
Although the EPA does not anticipate reductions in HAP emissions as a result of the proposed amendments, we believe that the action, if finalized as proposed, would result in improvements to the rule. Specifically, the proposed amendments revise the standards such that they apply at all times. For facilities who choose to operate under an initial startup period, the EPA is proposing an alternative work practice standard that will ensure that facilities are minimizing emissions while the source operates under non-steady state production, which will protect public health and the environment. Additionally, the proposed amendments requiring electronic submittal of initial notifications, initial startup reports, annual compliance certifications, deviation reports, and performance test results will increase the usefulness of the data, is in keeping with current trends of data availability, will further assist in the protection of public health and the environment, and will ultimately result in less burden on the regulated community. See section IV.D.2 of this preamble for more information.
We solicit comments on all aspects of this proposed action. In addition to general comments on this proposed action, we are also interested in additional data that may improve the risk assessments and other analyses. We are specifically interested in receiving any improvements to the data used in the site-specific emissions profiles used for risk modeling. Such data should include supporting documentation in sufficient detail to allow characterization of the quality and representativeness of the data or information. Section VII of this preamble provides more information on submitting data.
The site-specific emissions profiles used in the source category risk and demographic analyses and instructions are available for download on the RTR website at
If you believe that the data are not representative or are inaccurate, please identify the data in question, provide your reason for concern, and provide any “improved” data that you have, if available. When you submit data, we request that you provide documentation of the basis for the revised values to support your suggested changes. To submit comments on the data downloaded from the RTR website, complete the following steps:
1. Within this downloaded file, enter suggested revisions to the data fields appropriate for that information.
2. Fill in the commenter information fields for each suggested revision (
3. Gather documentation for any suggested emissions revisions (
4. Send the entire downloaded file with suggested revisions in Microsoft® Access format and all accompanying documentation to Docket ID No. EPA-HQ-OAR-2017-0015 (through the method described in the
5. If you are providing comments on a single facility or multiple facilities, you need only submit one file for all facilities. The file should contain all suggested changes for all sources at that facility (or facilities). We request that all data revision comments be submitted in the form of updated Microsoft® Excel files that are generated by the Microsoft® Access file. These files are provided on the RTR website at
Additional information about these statutes and Executive Orders can be found at
This action is not a significant regulatory action and was, therefore, not submitted to OMB for review.
This action is not expected to be an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866.
The information collection activities in this proposed rule have been submitted for approval to OMB under the PRA. The ICR document that the EPA prepared has been assigned EPA ICR number 2072.06. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here.
We are proposing changes to the reporting and recordkeeping requirements for the Lime Manufacturing Plants NESHAP in the form of eliminating the SSM reporting and SSM plan requirements and requiring electronic submittal of all compliance reports (including performance test reports). Any information submitted to the Agency for which a claim of confidentiality is made will be safeguarded according to the Agency policies set forth in title 40, chapter 1, part 2, subpart B—Confidentiality of Business Information (see 40 CFR 2; 41 FR 36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979).
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 the EPA's regulations in 40 CFR are listed in 40 CFR part 9.
Submit your comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden to the EPA using the docket identified at the beginning of this rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs via email to
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. This action only proposes to eliminate the startup/shutdown exemption and add electronic reporting. Neither of the changes being proposed will impact the small entities. The proposal to remove the startup/shutdown exemption will include proposing a work practice standard for those periods. Based on the controls used at the small entities, they will not be impacted by the proposed work practices. Thus, this action will not impose any requirements on small entities.
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local, or tribal governments or the private sector.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications as specified in Executive Order 13175. The EPA does not know of any lime manufacturing facilities owned or operated by Indian tribal governments. Thus, Executive Order 13175 does not apply to this action.
This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because the EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. This action's health and risk assessments are contained in sections III and IV of this preamble and further documented in the risk report titled
This action is not subject to Executive Order 13211, because it is not a
This action involves technical standards. The EPA proposes to use ANSI/ASME PTC 19.10-1981 Part 10 (2010), “Flue and Exhaust Gas Analyses,” as an acceptable alternative to EPA Method 3B manual portion only and not the instrumental portion. This method determines quantitatively the gaseous constituents of exhausts resulting from stationary combustion sources. This standard may be obtained from
The EPA proposes to use ASTM D6348-12e1, Determination of Gaseous Compounds by Extractive Direct Interface Fourier Transforn (FTIR) Spectroscopy,” as an alternative to using EPA Method 320 under certain conditions and incorporate this alternative by reference. ASTM D6348-03(2010) was previously determined equivalent to EPA Method 320 with caveats. ASTM D6348-12e1 is a revised version of ASTM D6348-03(2010) and includes a new section on accepting the results from direct measurement of a certified spike gas cylinder, but still lacks the caveats we placed on the ASTM D6348-03(2010) version. The voluntary consensus standard (VCS), ASTM D6348-12e1, “Determination of Gaseous Compounds by Extractive Direct Interface Fourier Transforn (FTIR) Spectroscopy,” is an acceptable alternative to EPA Method 320 at this time with caveats requiring inclusion of selected annexes to the standard as mandatory. When using ASTM D6348-12e1, the conditions that must be met are defined in 40 CFR 63.7142(a)(2). This field test method employs an extractive sampling system to direct stationary source effluent to an FTIR spectrometer for the identification and quantification of gaseous compounds. The ASTM D6348-12el standard was developed and adopted by the American Society for Testing and Materials (ASTM).
The EPA also proposes to use ASTM D6735-01 (Reapproved 2009), “Standard Test Method for Measurement of Gaseous Chlorides and Fluorides from Mineral Calcining Exhaust Sources Impinger Method,” as an alternative to EPA Method 321 provided that the provisions in 40 CFR 63.7142(a)(4) are followed. The EPA used ASTM D6735-01 for the determination of HCl in EPA Methods 26, 26A, and 321 from mineral calcining exhaust sources. This method will measure the gaseous hydrochloric acid and other gaseous chlorides and flurides that passes through a particulate matter filter. The ASTM D6735-01 standard was developed and adopted by the ASTM.
The EPA proposes to use VCS ASTM D6420-99 (Reapproved 2010), “Test Method for Determination of Gaseous Organic Compounds by Direct Interface Gas Chromatography/Mass Spectrometry” as an alternative to EPA Method 18 only when the target compunds are all known, and the target compounds are all listed in ASTM D6420 as measurable. ASTM D6420 should not be used for methane and ethane because atomic mass is less than 35. ASTM D6420 should never be specified as a total VOC method. This field method determines the mass concentration of volatile organic hazardous air pollutants.
The ASTM standards may be obtained from
The EPA proposes to use EPA-454/R-98-015, Office of Air Quality Planning and Standards (OAQPS), Fabric Filter Bag Leak Detection Guidance, September 1997 as guidance for how a triboelectric bag leak detection system must be installed, calibrated, operated, and maintained. This document includes fabric filter and monitoring system descriptions; guidance on monitor selection, installation, set up, adjustment, and operation; and quality assurance procedures.This document may be obtained from
While the EPA has identified another 10 VCS as being potentially applicable to this proposed rule, we have decided not to use these VCS in this rulemaking. The use of these VCS would not be practical due to lack of equivalency, documentation, validation date, and other import technical and policy considerations. See the memorandum titled
Under 40 CFR 63.7(f) and 40 CFR 63.8(f) of subpart A of the General Provisions, a source may apply to the EPA for permission to use alternative test methods or alternative monitoring requirements in place of any required testing methods, performance specifications, or procedures in the final rule or any amendments.
The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations, and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994).
The documentation for this decision is contained in section IV.B of this preamble and the technical report,
Environmental protection, Air pollution control, Hazardous substances, Incorporation by reference, Lime kilns, Lime manufacturing, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, 40 CFR part 63 is proposed to be amended as follows:
42 U.S.C. 7401,
(e) * * *
(2) ANSI/ASME PTC 19.10-1981 (2010), Flue and Exhaust Gas Analyses (Part 10, Instruments and Apparatus), re-issued 2010, IBR approved for table 4 to subpart AAAAA.
(h) * * *
(85) ASTM D6348-12e1, Standard Test Method for Determination of Gaseous Compounds by Extractive Direct Interface Fourier Transform
(91) ASTM D6420-99 (Reapproved 2010), Standard Test Method for Determination of Gaseous Organic Compounds by Direct Interface Gas Chromatography-Mass Spectrometry, Approved October 1, 2010, IBR approved for §§ 63.670(j), 63.7142(b), and appendix A to this part: Method 325B.
(96) ASTM D6735-01 (Reapproved 2009), Standard Test Method for Measurement of Gaseous Chlorides and Fluorides from Mineral Calcining Exhaust Sources—Impinger Method, IBR approved for § 63.7142(a), tables 4 and 5 to subpart JJJJJ, and tables 4 and 6 to subpart KKKKK.
(n) * * *
(3) EPA-454/R-98-015, Office of Air Quality Planning and Standards (OAQPS), Fabric Filter Bag Leak Detection Guidance, September 1997,
(a) * * *
(1) If you start up your affected source before January 5, 2004, you must comply with the emission limitations no later than January 5, 2004, and you must have completed all applicable performance tests no later than July 5, 2004, except as noted in paragraphs (e)(1) and (2) of this section.
(2) If you start up your affected source after January 5, 2004, then you must comply with the emission limitations for new affected sources upon startup of your affected source and you must have completed all applicable performance tests no later than 180 days after startup, except as noted in paragraphs (e)(1) and (2) of this section.
(b) If you have an existing affected source, you must comply with the applicable emission limitations for the existing affected source, and you must have completed all applicable performance tests no later than January 5, 2007, except as noted in paragraphs (e)(1) and (2) of this section.
(e)(1) If the start up of your existing, new, or reconstructed source occurs on or before [DATE OF PUBLICATION OF FINAL RULE IN THE
(2) If the initial start up of your new or reconstructed source occurs after [DATE OF PUBLICATION OF FINAL RULE IN THE
(c) After [DATE 180 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE
(1) During startup you must fire your kiln with any one or combination of the following clean fuels: natural gas, synthetic natural gas, propane, distillate oil, synthesis gas (syngas), or ultra-low sulfur diesel (ULSD) until the kiln reaches a temperature of 1200 degrees Fahrenheit.
(2) Combustion of the primary kiln fuel may commence once the kiln temperature reaches 1200 degrees Fahrenheit.
(3) Kilns and coolers (if there is a separate exhaust to the atmosphere from the associated lime cooler) equipped with a fabric filter (FF) must comply with the opacity operating limit in Table 2 in lieu of the particulate (PM) emission limits.
(4) Kilns and coolers (if there is a separate exhaust to the atmosphere from the associated lime cooler) equipped with a wet scrubber must meet the scrubber liquid flow rate operating limit in Table 2 in lieu of the PM emission limits.
(5) For kilns and coolers (if there is a separate exhaust to the atmosphere from the associated lime cooler) equipped with an electrostatic precipitator (ESP), the ESP must be turned on and operating at the time the gas stream at the inlet to the ESP reaches 300 degrees Fahrenheit (five-minute average) during startup. Temperature of the gas stream is to be measured at the inlet of the ESP every minute.
(6) You must keep records as specified in § 63.7132 during periods of startup and shutdown.
(a) Prior to [DATE 181 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE
(b) Prior to [DATE 181 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE
(c) Prior to [DATE 181 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE
(d) * * *
(3) Procedures for the proper operation and maintenance of each emission unit and each air pollution control device used to meet the applicable emission limitations and operating limits in Tables 1 and 2 to this subpart, respectively. After [DATE 180 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE
(4) * * *
(iii) Prior to [DATE 181 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE
(e) For affected sources until [DATE 180 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE
(b) Prior to [DATE 181 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE
(c) Prior to [DATE 181 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE
(k) * * *
(3) The observer conducting the VE checks need not be certified to conduct EPA Method 9 in appendix A-4 to part 60 of this chapter, but must meet the training requirements as described in EPA Method 22 in appendix A-7 to part 60 of this chapter.
(l) When determining compliance with the opacity standards for fugitive emissions from PSH operations in item 8 of Table 1 to this subpart, you must conduct EPA Method 9 in appendix A-4 to part 60 of this chapter according to item 17 in Table 4 to this subpart, and in accordance with paragraphs (l)(1) through (3) of this section.
(m) After to [DATE 180 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE
The revisions and additions read as follows:
(d) For each bag leak detection system (BLDS), you must meet any applicable requirements in paragraphs (a)(1) through (5) and (d)(1) through (9) of this section.
(3) The BLDS must be equipped with a device to continuously record the output signal from the sensor.
(7) Each triboelectric BLDS must be installed, calibrated, operated, and maintained according to EPA-454/R-98-015, “Fabric Filter Bag Leak Detection Guidance,” (incorporated by reference, see § 63.14). Other types of bag leak detection systems must be installed, operated, calibrated, and maintained according to the manufacturer's written specifications and recommendations. Standard operating procedures must be incorporated into the OM&M plan.
(8) At a minimum, initial adjustment of the system must consist of establishing the baseline output in both of the following ways, according to section 5.0 of the EPA-454/R-98-015, “Fabric Filter Bag Leak Detection Guidance,” (incorporated by reference, see § 63.14):
(9) After initial adjustment, the sensitivity or range, averaging period, alarm set points, or alarm delay time may not be adjusted except as specified in the OM&M plan required by § 63.7100(d). In no event may the range be increased by more than 100 percent or decreased by more than 50 percent over a 365-day period unless such adjustment follows a complete FF inspection that demonstrates that the FF is in good operating condition, as defined in section 5.2 of the EPA-454/R-98-015, “Fabric Filter Bag Leak Detection Guidance,” (incorporated by reference, see § 63.14). Record each adjustment.
(10) Record the results of each inspection, calibration, and validation check.
(h) After [DATE 180 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE
(1) You must install, calibrate, maintain, and continuously operate a CMS to record the temperature of the exhaust gases at the inlet to, or upstream of, the ESP.
(2) The temperature recorder response range must include zero and 1.5 times the average temperature established during your performance test according to the requirements in § 63.7112(m).
(3) The calibration reference for the temperature measurement must be a National Institute of Standards and Technology calibrated reference thermocouple-potentiometer system or alternate reference, subject to approval by the Administrator.
(4) The calibration of all thermocouples and other temperature sensors must be verified at least once every three months.
(5) You must monitor and continuously record the temperature of the exhaust gases from the kiln and cooler, if applicable, at the inlet to the kiln and/or cooler ESP.
(b) You must report each instance in which you did not meet each operating limit, work practice, opacity limit, and VE limit in Tables 2 and 6 to this subpart that applies to you. This includes periods of startup, shutdown, and malfunction. These instances are deviations from the emission limitations in this subpart. These deviations must be reported according to the requirements in § 63.7131.
(d) Prior to [DATE 181 DAYS AFTER THE DATE OF PUBLICATION OF FINAL RULE IN
(e) If you are required to conduct a performance test, design evaluation, opacity observation, VE observation, or other initial compliance demonstration as specified in Table 3 or 4 to this subpart, you must submit a Notification of Compliance Status according to § 63.9(h)(2)(ii). Beginning on [DATE 180 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE
The revisions and additions read as follows:
(b) Unless the Administrator has approved a different schedule for submission of reports under § 63.10(a), you must submit each report by the date specified in Table 7 to this subpart and according to the requirements in paragraphs (b)(1) through (6) of this section:
(6) Beginning on [DATE 180 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE
(c) * * *
(4) Prior to [DATE 181 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE
(5) If there were no deviations from any emission limitations (emission limit, operating limit, work practice, opacity limit, and VE limit) that apply to you, the compliance report must include a statement that there were no deviations from the emission limitations during the reporting period.
(6) If there were no periods during which the continuous monitoring systems (CMS), including CPMS, were out-of-control as specified in § 63.8(c)(7), a statement that there were no periods during which the CMS were out-of-control during the reporting period.
(d) For each deviation from an emission limitation (emission limit, operating limit, work practice, opacity limit, and VE limit) that occurs at an affected source where you are not using a CMS to comply with the emission limitations in this subpart, the compliance report must contain the information specified in paragraphs (c)(1) through (4) and (d)(1) and (2) of this section. The deviations must be reported in accordance with the requirements in § 63.10(d) prior to [DATE 181 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE
(1) The total operating time of each emission unit during the reporting period.
(2) Information on the number, duration, and cause of deviations (including unknown cause, if applicable), and the corrective action taken.
(3) An estimate of the quantity of each regulated pollutant emitted over any emission limit, and a description of the method used to estimate the emissions.
(e) For each deviation from an emission limitation (emission limit, operating limit, work practice, opacity limit, and VE limit) occurring at an affected source where you are using a CMS to comply with the emission limitation in this subpart, you must include the information specified in paragraphs (c)(1) through (4) and (e)(1) through (11) of this section, except that after [DATE 180 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE
(2) The date, time, and duration that each CMS was inoperative, except for zero (low-level) and high-level checks.
(12) An estimate of the quantity of each regulated pollutant emitted over any emission limit, and a description of the method used to estimate the emissions.
(f) Each facility that has obtained a title V operating permit pursuant to part 70 or part 71 of this chapter must report all deviations as defined in this subpart in the semiannual monitoring report required by §§ 70.6(a)(3)(iii)(A) or 71.6(a)(3)(iii)(A) of this chapter. If you submit a compliance report specified in Table 7 to this subpart along with, or as part of, the semiannual monitoring report required by §§ 70.6(a)(3)(iii)(A) or 71.6(a)(3)(iii)(A) of this chapter, and the compliance report includes all required information concerning deviations from any emission limitation (including any operating limit and work practice), submission of the compliance report shall be deemed to satisfy any obligation to report the same deviations in the semiannual monitoring report. However, submission of a compliance report shall not otherwise affect any obligation you may have to report deviations from permit requirements to the permit authority.
(g) If you are required to submit reports following the procedure specified in this paragraph, you must submit reports to the EPA via the Compliance and Emissions Data Reporting Interface (CEDRI), which can be accessed through the EPA's Central Data Exchange (CDX) (
(h)
(1)
(2)
(3)
(i) If you are required to electronically submit a report or notification through CEDRI in the EPA's CDX, you may assert a claim of EPA system outage for failure to timely comply with the reporting requirement. To assert a claim of EPA system outage, you must meet the requirements outlined in paragraphs (i)(1) through (7) of this section.
(1) You must have been or will be precluded from accessing CEDRI and submitting a required report within the time prescribed due to an outage of either the EPA's CEDRI or CDX systems.
(2) The outage must have occured within the period of time beginning five business days prior to the date that the submission is due.
(3) The outage may be planned or unplanned.
(4) You must submit notification to the Administrator in writing as soon as possible following the date you first knew, or through due diligence should have known, that the event may cause or has caused a delay in reporting.
(5) You must provide to the Administrator a written description identifying:
(i) The date(s) and time(s) when CDX or CEDRI was accessed and the system was unavailable;
(ii) A rationale for attributing the delay in reporting beyond the regulatory deadline to EPA system outage;
(iii) Measures taken or to be taken to minimize the delay in reporting; and
(iv) The date by which you propose to report, or if you have already met the reporting requirement at the time of the notification, the date you reported.
(6) The decision to accept the claim of EPA system outage and allow an extension to the reporting deadline is solely within the discretion of the Administrator.
(7) In any circumstance, the report must be submitted electronically as soon as possible after the outage is resolved.
(j)
(1) You may submit a claim if a force majeure event is about to occur, occurs, or has occurred or there are lingering effects from such an event within the period of time beginning five business days prior to the date the submission is due. For the purposes of this section, a force majeure event is defined as an event that will be or has been caused by circumstances beyond the control of the affected facility, its contractors, or any entity controlled by the affected facility that prevents you from complying with the requirement to submit a report electronically within the time period prescribed. Examples of such events are acts of nature (
(2) You must submit notification to the Administrator in writing as soon as possible following the date you first knew, or through due diligence should have known, that the event may cause or has caused a delay in reporting.
(3) You must provide to the Administrator:
(i) A written description of the force majeure event;
(ii) A rationale for attributing the delay in reporting beyond the regulatory deadline to the force majeure event;
(iii) Measures taken or to be taken to minimize the delay in reporting; and
(iv) The date by which you propose to report, or if you have already met the reporting requirement at the time of the notification, the date you reported.
(4) The decision to accept the claim of force majeure and allow an extension to the reporting deadline is solely within the discretion of the Administrator.
(5) In any circumstance, the reporting must occur as soon as possible after the force majeure event occurs.
(a) * * *
(2) Prior to [DATE 181 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE
(i) You must keep records of the date, time and duration of each startup and/or shutdown period for any affected source that is subject to a standard during startup or shutdown that differs from the standard applicable at other times.
(ii) You must keep records of the date, time, cause and duration of each malfunction that causes an affected source to fail to meet an applicable standard; if there was also a monitoring malfunction, the date, time, cause, and duration of the monitoring malfunction; the record must list the affected source or equipment, an estimate of the volume of each regulated pollutant emitted over the standard for which the source failed to meet a standard, and a description of the method used to estimate the emissions.
(iii) For kilns and coolers equipped with an ESP, the average of the run average temperatures determined in accordance with § 63.7112(m) must be recorded.
(d) Any records required to be maintained by this part that are submitted electronically via the EPA's CEDRI may be maintained in electronic format. This ability to maintain electronic copies does not affect the requirement for facilities to make records, data, and reports available upon request to a delegated air agency or the EPA as part of an on-site compliance evaluation.
Table 8 to this subpart shows which parts of the General Provisions in §§ 63.1 through 63.16 apply to you. When there is overlap between 40 CFR part 63, subpart A, and 40 CFR part 63, subpart AAAAA, as indicated in the “Explanations” column in Table 8, 40 CFR part 63, subpart AAAAA takes precedence.
The revisions and additions read as follows:
(c) The authorities that will not be delegated to state, local, or tribal agencies are as specified in paragraphs (c)(1) through (8) of this section.
(4) Approval of alternatives to the work practices in § 63.7090(c).
(8) Approval of an alternative to any electronic reporting to the EPA required by this subpart.
The revisions and additions read as follows:
(a) * * *
(1) EPA Method 320 of appendix A to this part, or
(2) As an alternative to EPA Method 320, ASTM D6348-12e1, Determination of Gaseous Compounds by Extractive Direct Interface Fourier Transform (FTIR) Spectroscopy (incorporated by reference, see § 63.14), provided that the provisions of paragraphs (a)(2)(i) and (ii) of this section are followed:
(i) The test plan preparation and implementation in the Annexes to ASTM D 6348-12e1, Sections A1 through A8 are mandatory.
(ii) In ASTM D6348-12e1 Annex A5 (Analyte Spiking Technique), the percent recovery (%R) must be determined for each target analyte (Equation A5.5). In order for the test data to be acceptable for a compound, %R must be greater than or equal to 70 percent and less than or equal to 130 percent. If the %R value does not meet this criterion for a target compound, the test data are not acceptable for that compound and the test must be repeated for that analyte (
(4) As an alternative to EPA Method 321, ASTM Method D6735-01 (Reapproved 2009), Standard Test Method for Measurement of Gaseous Chlorides and Fluorides from Mineral Calcining Exhaust Sources—Impinger Method (incorporated by reference, see § 63.14), provided that the provisions in paragraphs (a)(4)(i) through (vi) of this section are followed.
(i) A test must include three or more runs in which a pair of samples is obtained simultaneously for each run according to section 11.2.6 of ASTM Method D6735-01 (Reapproved 2009).
(v) The post-test analyte spike procedure of section 11.2.7 of ASTM Method D6735-01 (Reapproved 2009) is conducted, and the percent recovery is
(b) * * *
(2) As an alternative to Method 320, ASTM D6348-12e1, Determination of Gaseous Compounds by Extractive Direct Interface Fourier Transform (FTIR) Spectroscopy (incorporated by reference, see § 63.14), provided that the provisions of paragraphs (b)(2)(i) and (ii) of this section are followed:
(i) The test plan preparation and implementation in the Annexes to ASTM D 6348-12e1, Sections A1 through A8 are mandatory.
(ii) In ASTM D6348-12e1 Annex A5 (Analyte Spiking Technique), the percent recovery (%R) must be determined for each target analyte (Equation A5.5). In order for the test data to be acceptable for a compound, %R must be greater than or equal to 70 percent and less than or equal to 130 percent. If the %R value does not meet this criterion for a target compound, the test data are not acceptable for that compound and the test must be repeated for that analyte (
(3) Method 18 of appendix A-6 to part 60 of this chapter; or
(4) As an alternative to Method 18, ASTM D6420-99 (Reapproved 2010), Standard Test Method for Determination of Gaseous Organic Compounds by Direct Interface Gas Chromatography-Mass Spectrometry (GC/MS) (incorporated by reference, see § 63.14), provided that the provisions of paragraphs (b)(4)(i) through (iii) of this section are followed:
(i) The target compound(s) are those listed in section 1.1 of ASTM D6420-99 (Reapproved 2010) as measurable;
(ii) This ASTM should not be used for methane and ethane because their atomic mass is less than 35; and
(iii) ASTM D6420 (Reapproved 2010) should never be specified as a total VOC.
The revisions read as follows:
(3) Prior to [Date 181 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE
Nuclear Regulatory Commission.
Proposed rule and draft regulatory guide; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its regulations regarding fitness for duty (FFD) programs for certain NRC licensees and other entities to more closely align the NRC's drug testing requirements with the updates made to the U.S. Department of Health and Human Services “Mandatory Guidelines for Federal Workplace Drug Testing Programs” in 2008, which became effective on October 1, 2010. The proposed rule would also incorporate lessons learned from implementation of the NRC's current FFD regulations. These changes would enhance the ability of NRC licensees and other entities to identify individuals using illegal drugs, misusing legal drugs, or attempting to subvert the drug testing process. The proposed rule would also provide additional protections to individuals subject to drug testing and would improve the clarity, organization, and flexibility of the NRC's FFD regulations. The NRC is also requesting comment on draft regulatory guide 5040.
Submit comments by December 2, 2019. Comments received after this date will be considered if it is practical to do so, but the NRC is able to assure consideration only for comments received on or before this date.
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
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For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Stewart Schneider, Office of Nuclear Material Safety and Safeguards, telephone: 301-415-4123; email:
The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its regulations regarding fitness for duty (FFD) programs for certain NRC licensees and other entities to more closely align the NRC's drug testing requirements with the updates made in 2008 to the U.S. Department of Health and Human Services (HHS) “Mandatory Guidelines for Federal Workplace Drug Testing Programs” (HHS Guidelines), which were published in the
Major provisions of the proposed rule include the following:
• Add initial and confirmatory drug testing for two illegal amphetamine-based controlled substances—methylenedioxymethamphetamine (MDMA) and methylenedioxyamphetamine (MDA)—referred to as Ecstasy-type drugs in this proposed rule.
• Add initial drug testing for 6-acetylmorphine (6-AM), a metabolite of the illegal drug heroin, and update the confirmatory drug testing method for 6-AM.
• Lower the drug testing cutoff levels for amphetamine, cocaine metabolite, and methamphetamine.
• Enhance the detection of subversion attempts by strengthening the testing methods used to identify drugs and drug metabolites in urine specimens with dilute validity test results and in specimens collected under direct observation.
• Require Medical Review Officers (MROs) to evaluate the elapsed time from specimen collection to testing and exposure to high temperature, as possible causes of some invalid test results due to high solvated hydrogen ion concentration (
• Improve the clarity, consistency, and organization of 10 CFR part 26 by adding and updating definitions; increase flexibility by addressing personnel who may monitor a donor in a shy-bladder situation who is hydrating; and enhance both donor protections by providing additional
The NRC prepared a draft regulatory analysis to quantify the costs and benefits of the proposed rule, as well as to examine the qualitative factors to be considered in the NRC's rulemaking decision. The analysis concluded that the proposed rule would result in net costs to the industry. The proposed rule, relative to the regulatory baseline, would result in a net cost to industry of between $2.4 million based on a 7 percent net present value and $3.4 million based on a 3 percent net present value. The estimated average net cost per licensee or other entity site would be a one-time cost of $5,031 and an annual cost of $2,516. Thirteen qualitative factors were evaluated in the draft regulatory analysis: Public health (accident), occupational health (accident), offsite property, onsite property, regulatory efficiency, safeguards and security considerations, and other considerations (public perception, public trust, worker productivity, improved protection of individual rights, work environment free of drugs and the effects of such substances, safety vulnerability, and security vulnerability). The draft regulatory analysis includes a narrative discussion of each qualitative factor.
If the results of the regulatory analysis were based solely on the costs and the benefits that could be quantified, then the regulatory analysis would show that rulemaking is not justified because the total estimated quantified benefits of the proposed regulatory action do not equal or exceed the estimated costs of the proposed regulatory action. However, when the qualitative benefits are considered, together with the quantified benefits, then the benefits outweigh the identified quantitative and qualitative impacts.
In the draft regulatory analysis, the NRC concluded that the proposed rule should be adopted because it would result in a 10- to 12-percent increase per year in the detection of individuals using drugs or attempting to subvert the drug testing process. In comparison to the test results from calendar years 2013 and 2014, the estimated increase in detection each year is equivalent to identifying approximately 95 additional individuals using illegal drugs, misusing legal drugs, or attempting to subvert the drug testing process. This improved detection would prevent drug-using individuals from gaining or maintaining unescorted access authorization to NRC-licensed facilities (
For more information, please see the regulatory analysis (Accession No. ML19169A115 in the NRC's Agencywide Documents Access and Management System (ADAMS)).
Please refer to Docket ID NRC-2009-0225 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
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Please include Docket ID NRC-2009-0225 in your comment submission.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
Through Executive Order 12564 (51 FR 32889; September 17, 1986), the President of the United States designated the Department of Health and Human Services (HHS) as the Federal agency responsible for establishing and maintaining the requirements and guidance for conducting Federal employee workplace
The HHS Guidelines also established the certification requirements that each laboratory must meet to test specimens for Federal employee workplace drug testing programs. To obtain certification, a laboratory must successfully complete several rounds of performance testing and a National Laboratory Certification Program (NLCP) inspection. The certification requirements include, but are not limited to, laboratory staffing and qualifications, testing procedures, quality assurance and quality control, and results reporting. Once certified, each laboratory is subject to quarterly performance testing and NLCP inspection every 6 months to verify adherence to the HHS Guidelines. The HHS laboratory certification process provides assurance to the NRC, licensees, and other entities that the testing of specimens, under 10 CFR part 26, is conducted with the highest standards of accuracy, precision, and quality.
Periodically, HHS updates the HHS Guidelines to enhance testing program effectiveness based on advances in drug testing technologies, processes, methodologies, and instrumentation; revise the authorized substances in the testing panel as societal drug-use trends change; and incorporate lessons learned from the NLCP. Each revision of the HHS Guidelines is published following a rigorous process that includes scientific, policy, legal, and technical review by the independent Drug Testing Advisory Board, which advises the Administrator of the HHS Substance Abuse and Mental Health Services Administration (SAMHSA); academic peer reviews; public review and comment; and input from Federal agencies that implement the HHS Guidelines. The HHS also conducts extensive outreach with affected stakeholders and researches societal drug-use trends to promulgate effective drug testing methods.
The HHS Guidelines govern the drug testing programs of over 100 Federal agencies that test Federal employees; are used by many Federal agencies that test civilians in safety- and security-sensitive positions similar to personnel tested under 10 CFR part 26, such as the U.S. Department of Transportation (DOT); and by many private entities. The NRC has historically relied on HHS to establish the technical requirements for urine specimen collection, specimen testing and test result evaluation, and in general only deviates from the HHS Guidelines for considerations specific to the nuclear industry. The NRC relies on the HHS Guidelines as part of its technical basis for the drug testing requirements contained under 10 CFR part 26. Updating 10 CFR part 26 to align with changes in the 2008 HHS Guidelines would help to ensure that the NRC's regulations continue to be scientifically and technically sound.
In the 1970s, the NRC and the commercial nuclear power industry began addressing concerns about the potential public health and safety impacts of fitness for duty (FFD) problems at nuclear power plants. Most nuclear utilities voluntarily implemented FFD programs during the 1980s, and the NRC monitored the comprehensiveness and effectiveness of these programs. On August 4, 1986 (51 FR 27921), the NRC published the Commission Policy Statement on Fitness for Duty of Nuclear Power Plant Personnel, which outlined the need for nuclear power plant licensees to implement programs to address FFD problems—including illegal drug use, alcohol abuse, misuse of legal drugs, and any other mental or physical problems that could impair job performance. An evaluation of licensee programs following the implementation of the policy statement identified a wide range in the quality and comprehensiveness of licensee FFD testing programs that ultimately resulted in the NRC's decision to pursue rulemaking.
The NRC published a final rule, entitled “Fitness-for-Duty Programs,” in the
The NRC issued the first substantial revision to 10 CFR part 26 in a final rule on March 31, 2008 (73 FR 16966; hereafter referred to as the “2008 FFD final rule”). The 2008 FFD final rule updated the NRC's drug testing requirements to align with the then-latest HHS Guidelines, which were issued in 2004 (69 FR 19644; April 13, 2004). The 10 CFR part 26 updates included the following: (1) Required validity testing of each specimen to address the potential for subversion of the testing process, (2) advancements in drug and alcohol testing technologies, (3) changes to drug and alcohol testing cutoff levels, and (4) lessons learned from the implementation of 10 CFR part 26 since its addition in 1989.
On November 25, 2008, HHS issued the 2008 HHS Guidelines (73 FR 71858), which included the following: (1) An expanded drug testing panel, (2) lower drug testing cutoff levels for some substances, (3) advances in testing technologies, and (4) more detailed requirements for specimen collectors and MROs. The 2008 HHS Guidelines became effective on October 1, 2010. The 2008 Guidelines' updates to the 2004 Guidelines are currently not reflected in 10 CFR part 26.
In the 2008 HHS Guidelines, HHS enhanced the detection of illegal drug use and the misuse of prescription drugs through the following changes: (1) Lowering the initial and confirmatory testing cutoff levels for amphetamine, cocaine, and methamphetamine; (2) establishing an initial testing requirement and revising the confirmatory testing cutoff level for the heroin metabolite 6-AM; and (3) establishing testing for Ecstasy-type drugs (which are part of the amphetamine class of drugs).
The effectiveness of the 2008 HHS Guidelines is demonstrated by the enhanced detection evident in the test results reported by HHS, the DOT, and Quest Diagnostics® (Quest), which is an HHS-certified laboratory that conducts testing for both Federal workplace drug testing programs (
As detailed in the NRC report, “Summary of Fitness for Duty Performance Reports for Calendar Year 2013,” an adverse trend in the commercial nuclear industry had been observed over the prior 5 years associated with the year-over-year increases in amphetamines
While most of the proposed changes in this rulemaking would be made to better align 10 CFR part 26 with the 2008 HHS Guidelines, some are based on lessons learned during the implementation of the 2008 FFD final rule by licensees and other entities. In particular, the NRC is proposing a number of changes that would enhance the ability of licensees and other entities to identify individuals attempting to subvert the drug testing process.
Beginning in 2009, licensees and other entities had the option to use electronic reporting forms (e-forms) created by the NRC, in collaboration with licensees and other entities, in order to meet the annual FFD drug and alcohol testing program reporting requirements in § 26.717, “Fitness-for-duty program performance data” and § 26.417(b)(2). These e-forms
Analysis of FFD program performance data from 2011 through 2014 identified a significant new trend: The prevalence of subversion attempts of the drug testing process. In 2011, over 13.2 percent of the total testing violations were donor subversion attempts (143 of 1,080 testing violations), with even more subversion attempts in subsequent years: 15.9 percent in 2012 (177 of 1,114 testing violations), 14.7 percent in 2013 (148 of 1,007 violations), and 16.5 percent in 2014 (187 of 1,133 testing violations). If the number of alcohol positive testing violations is removed from the total testing violations each year, the percentage of drug testing violations determined to be subversion attempts increases to 17.5 percent in 2011, 20.6 percent in 2012, 19.2 percent in 2013, and 21.3 percent in 2014. An attempt to subvert the testing process demonstrates a lack of integrity and honesty and a willful act to refuse to comply with an NRC-required drug test (see 10 CFR 26.89(c), 26.825, “Criminal penalties,” and 50.5, “Deliberate misconduct”). Consequently, drug-using individuals present a safety vulnerability because of the potential for human performance issues due to drug use. Drug-using individuals could also present a security vulnerability because of their impairment or willful misconduct. As a result, the NRC is proposing a number of changes in this proposed rule to enhance the ability of FFD testing programs to detect individuals attempting to subvert the drug testing process.
Stakeholder outreach on the proposed rule is described in Section III.B of this document. The basis for each proposed change is discussed in Section III.C of this document. The regulatory basis for this proposed rule, issued on May 10, 2013, provides further discussion on the technical merits of this rulemaking.
As described in the President's 2014 “National Drug Control Strategy,” societal use of legal and illegal drugs and substances continues to evolve and affects every sector of society. The prevalence of drug use in society is also documented in the “Behavioral Health Trends in the United States: Results from the 2014 National Survey on Drug Use and Health” (NSDUH), an annual survey sponsored by SAMHSA. This survey is the primary source of information on the use of illegal drugs, alcohol, and tobacco in the civilian, non-institutionalized population in the United States, ages 12 and older. The NSDUH survey estimated that in 2014, 10.2 percent of the U.S. population aged 12 or older (approximately 27.0 million Americans) used an illegal drug in the past month. This estimate was based on the number of individuals surveyed that reported using an illegal drug during the month prior to participating in the NSDUH survey interview. Among adults aged 26 or older, those potentially in the U.S. workforce, the rate of illegal drug
After HHS issued the 2008 HHS Guidelines, the NRC performed a comprehensive review of 10 CFR part 26 and the 2008 HHS Guidelines to identify provisions in the NRC's regulations that may need to be revised. Two public meetings were held in 2009, on February 24 and June 24, with regulated entities, interest groups, and members of the general public to discuss the changes in the 2008 HHS Guidelines. In 2010, the NRC analyzed the DOT's final rule changes to 49 CFR part 40, “Procedures for Transportation Workplace Drug and Alcohol Testing Programs” (75 FR 49850; August 16, 2010) to understand how another Federal agency that tests civilians implemented the 2008 HHS Guidelines. The NRC also analyzed lessons learned from implementation of the 2008 FFD final rule. Collectively, these efforts resulted in a list of potential changes to 10 CFR part 26 that the NRC presented, for feedback, at a third public meeting held on October 11, 2011. The NRC summarized public comments received at the October 11 meeting, as well as emailed comments received subsequent to the meeting, in a document titled “Comments for the October 11, 2011, Public Meeting” (included as Enclosure 3 in package available via ADAMS Accession No. ML112930153). A fourth meeting was held on September 11, 2013, to inform the public of the status of the rulemaking. Public meetings were attended by representatives of nuclear power plant licensees, the Nuclear Energy Institute, the Institute of Nuclear Power Operations, the International Brotherhood of Electrical Workers, and HHS.
Based upon feedback received during the four public meetings, some of the NRC-proposed revisions were removed from consideration because the NRC decided that it was not appropriate to pursue those particular issues in this rulemaking, while others were revised. The NRC-proposed revisions, along with associated issues raised by the public, are discussed in Section III.C of this document.
This section includes a description of each proposed change, the rationale for each change, and a discussion of public comments that informed the NRC's development of the changes.
During the October 11, 2011, public meeting, an industry participant requested that the NRC review the use of certain terms under 10 CFR part 26 for consistency with the 2008 HHS Guidelines. The NRC performed a review and proposes to add seven new definitions and revise seven existing definitions under § 26.5, “Definitions.” The revisions and additions would improve consistency with Section 1.5 of the 2008 HHS Guidelines and would improve the clarity, consistency, and accuracy of the requirements under 10 CFR part 26. Specifically, the following definitions would be added:
The NRC's regulations under 10 CFR part 26 do not preclude the use of electronic versions of the Federal CCF or the use of licensee or other entity-developed forms, consistent with existing requirements in § 26.153(g). The NRC supports the use of technological advancements to improve the quality of information included on the Federal CCF (
The proposed rule would add two amphetamine-based chemical compounds: Methylenedioxymethamphetamine (MDMA) and methylenedioxyamphetamine (MDA) to the NRC-required drug testing panel, consistent with the drug testing panel in Section 3.4 of the 2008 HHS Guidelines. The 2008 HHS Guidelines also added an additional amphetamine-based chemical compound, methylenedioxyethylamphetamine (MDEA); however, in its 2017 mandatory guidelines (82 FR 7920; January 23, 2017) HHS subsequently removed MDEA from its drug testing panel because HHS determined that the number of positive MDEA specimens reported from its certified laboratories does not support testing specimens for MDEA. MDMA (also known as Ecstasy or Molly) and MDA are listed in Schedule I of the Schedules of Controlled Substances (21 CFR 1308.11). A Schedule I drug or substance has a high potential for abuse, has no currently accepted medical use in treatment in the United States, and lacks an accepted safety for use of the drug or substance under medical supervision (21 U.S.C. 812 (2012)). The proposed rule would revise §§ 26.31(d)(1) and 26.405(d) to identify MDMA and MDA as substances for which licensees and other entities are required to test; § 26.133, “Cutoff levels for drugs and drug metabolites,” and § 26.163(a)(1) to require initial testing for MDMA and MDA; and § 26.163(b)(1) to require confirmatory testing for MDMA and MDA. By requiring licensees and other entities to test for additional substances, a greater range of drugs that impair human performance can be detected. Also, it would assist in the identification of those persons who, because they use illegal drugs, exhibit characteristics of not being trustworthy and reliable. The drugs MDMA and MDA would be added to the NRC-required drug testing panel because of their potential adverse effects on human performance, which were detailed by the HHS in the notice of proposed revisions to the HHS Guidelines, published in the
The proposed rule would also expand the NRC-required drug testing panel to include initial testing for 6-AM, consistent with Section 3.4 of the 2008 HHS Guidelines. This change would improve the assurance that the testing method used under 10 CFR part 26 would identify an individual using heroin, a Schedule I drug. Currently, 10
The 2008 HHS Guidelines established the scientific and technical bases for lowering the initial drug testing cutoff levels for amphetamines and cocaine metabolites. The proposed rule would update the substances and cutoff levels for initial drug testing, as listed in the tables in §§ 26.133 and 26.163(a)(1), to conform with Section 3.4 of the 2008 HHS Guidelines. Specifically, the proposed rule would make the following changes in each table: (1) Lower the initial test cutoff level for amphetamines (abbreviated in the tables as AMP), (2) lower the initial test cutoff level for cocaine metabolites, (3) clarify the existing testing requirement for “opiate metabolites” by replacing the term with “codeine/morphine,” (4) include a new footnote 1 to each table to clarify that the target analyte for “codeine/morphine” testing is morphine, (5) clarify in a new footnote 2 to each table that either a single or multiple initial test kit(s) may be used for amphetamines testing, and (6) include a new footnote 3 in each table to clarify that methamphetamine (abbreviated in the tables as MAMP) is the target analyte for amphetamines and methamphetamine testing. The column header “Drug or metabolites” in the tables in §§ 26.133 and 26.163(b)(1) would also be revised to “Drugs or drug metabolites” to align with the table titles.
Lowering the cutoff levels for these existing drugs and drug metabolites in the NRC-required testing panel would increase the timeframe (
In addition, the proposed rule would revise §§ 26.133 and 26.163(a)(1) to clarify that the specified testing cutoff levels are used by an LTF or an HHS-certified laboratory to determine whether a specimen is either “negative” or “positive” for each drug or drug metabolite being tested. This change better aligns 10 CFR part 26 with Section 11.19(b) and (c) of the 2008 HHS Guidelines, which require the HHS-certified laboratory to make a determination that each specimen is either “negative” or “positive,” respectively, for each drug and drug metabolite tested.
The 2008 HHS Guidelines established the scientific and technical bases to justify lowering the confirmatory drug testing cutoff levels for amphetamine, cocaine metabolite, and methamphetamine and expanding the testing panel to include confirmatory drug testing for the Ecstasy drugs MDMA and MDA. The NRC proposes to expand the number of substances in the NRC-required testing panel and to lower the cutoff levels for confirmatory drug tests, as listed in the table in § 26.163(b)(1), to align with Section 3.4 of the 2008 HHS Guidelines. Specifically, the proposed rule would make the following changes: (1) Lower the confirmatory test cutoff level for amphetamine from 500 ng/mL
The proposed rule would update the information that each HHS-certified laboratory must include in the annual statistical summary report of test results provided to each licensee or other entity under § 26.169(h)(3) to reflect the expanded drug testing panel in revised §§ 26.31(d)(1) and 26.405. Specifically, the proposed rule would require each HHS-certified laboratory to include, in the annual statistical summary of urinalysis testing provided to each licensee and other entity, the number of specimens reported as positive for MDMA and MDA. Additional conforming changes would improve the clarity and uniformity of the names of the drugs and drug metabolites listed in § 26.169(h)(3), to include adding “(as THCA)”
The proposed rule would revise the decision point used in the validity tests performed by HHS-certified laboratories, as described in § 26.161(c)(3) through (c)(6) and § 26.161(f)(5) and (f)(7), by replacing the limit of detection (LOD) with the limit of quantitation (LOQ) as the decision point for determining if a specimen contains an adulterant (
The proposed changes to § 26.161(c)(3) through (c)(6) are consistent with Section 3.5 of the 2008 HHS Guidelines, which describes the validity testing criteria for the adulterants chromium (VI), halogens (
The NRC is not proposing to change the initial validity testing requirement in § 26.131(b)(5) that applies to LTF testing for the possible presence of halogen. Section 26.131(b)(5) currently permits an LTF to use a “halogen colorimetric test (halogen concentration equal to or greater than the limit of detection (LOD)).” The NRC is not proposing to change the use of LOD in this instance, because LTFs already must send any specimen identified with the possible presence of an adulterant to an HHS-certified laboratory for initial and confirmatory validity testing, where the LOQ of the test would be utilized.
The proposed rule would also revise § 26.161(c)(5) and (c)(6) to permit HHS-certified laboratories to conduct confirmatory validity testing for the adulterants glutaraldehyde and pyridinium chlorochromate using “a different confirmatory method (
Special analyses testing is an NRC testing methodology introduced in the 2008 FFD final rule to address the circumstance where a donor consumes a large quantity of fluid just prior to providing a urine specimen for testing in the hope of diluting the concentration of any drugs and drug metabolites in the specimen below the standard testing cutoff levels to avoid detection (
First, the proposed rule would require all licensees and other entities to conduct special analyses testing of dilute specimens. An analysis of the NRC's FFD program performance reports for calendar years 2011 through 2014 demonstrates the effectiveness of special analyses testing because these data show that additional positive results were identified for pre-access, random, and post-event special analyses tests. As of 2014, 92 percent of licensees and other entities have adopted the special analyses testing policy. The proposed rule would eliminate references to the option for licensees and other entities to conduct special analyses testing of specimens with dilute validity test results that appear in §§ 26.31(d)(1)(ii); 26.163(a)(1) and (b)(1); 26.183(c), (c)(1), and (d)(2)(ii); and 26.185(g)(2) and (g)(3). These tests would instead be required.
Second, the proposed rule would lower the immunoassay percentage response for initial testing in § 26.163(a)(2)(ii) that HHS-certified laboratories must use to determine if special analyses testing is to be conducted. The proposed rule would lower the immunoassay response from “equal to or greater than 50 percent of the cutoff calibrator” to “equal to or greater than 40 percent of the cutoff calibrator.” Use of a lower cutoff level to evaluate the immunoassay response could increase the number of specimens subject to special analyses testing and would improve the ability of licensees and other entities to identify drug-using individuals attempting to subvert the drug testing process. This change would not affect the drug testing assays used by HHS-certified laboratories because under the 2008 HHS Guidelines, each laboratory must already validate the accuracy of each assay to 40 percent of the cutoff calibrator. Laboratories would need to change their administrative procedures to define the initial test result concentration that would trigger special analyses testing.
Third, the proposed rule would replace the LOD with the LOQ as the confirmatory drug testing cutoff level to be used by HHS-certified laboratories when conducting special analyses testing. Currently, § 26.163(a)(2)(ii) requires the use of the LOD as the cutoff level for special analyses testing of dilute specimens. The difference between the LOD and the LOQ for a drug testing assay is the ability to reliably quantify the analyte. At the LOD, the confirmatory drug test must meet all HHS-certified laboratory criteria for result acceptance except quantitation. At the LOQ, the confirmatory drug test must reliably confirm the presence of the analyte, reliably quantify the concentration of the analyte, and meet all HHS-certified laboratory criteria for result acceptance. The LOQ provides an additional donor protection on the accuracy of special analyses test results. To receive and maintain laboratory certification by the NLCP, HHS-certified laboratories must already determine both the LOD and LOQ for each drug testing assay. Therefore, changing the decision point from the LOD to the LOQ for reporting confirmatory drug test results would not require laboratories to change the testing assays used.
The NLCP also requires all HHS-certified laboratories to validate the accuracy and precision of each confirmatory drug test at or below 40 percent of the cutoff. To meet this
Fourth, the proposed rule would expand the special analyses testing requirement in § 26.163(a)(2)(i) to include the testing of some specimens collected under direct observation. Section 26.115(a) describes the exclusive grounds for performing a directly observed collection. Under the current rule, a directly observed collection may be performed when sufficient information has been obtained during the collection process or in the testing of a previous specimen to indicate a possible subversion attempt by the donor or when an individual has a confirmed positive drug test result on a prior occasion. As such, a directly observed collection after either of these circumstances provides additional assurance that the subsequent specimen obtained for testing came directly from the donor's body and was not altered to avoid detection of drug use. Likewise, special analyses testing would provide additional assurance that drugs and drug metabolites present in the specimen collected under direct observation from a donor would be identified, which would improve the MRO's ability to determine whether a subversion attempt was made on the initial specimen collected from the donor. For example, an initial unobserved specimen provided by a donor is determined by the collector to be out of the acceptable temperature range specified in § 26.111(a) and tests negative for drugs, and the second specimen collected under direct observation from the donor tests positive for a drug. In this example, the differences in test results from the initial and second specimen collected provides conclusive evidence to the MRO to make a subversion determination on the initial specimen provided. Therefore, the proposed rule would revise § 26.163(a)(2)(i) to require that special analyses testing be performed on specimens collected under § 26.115(a)(1) through (a)(3), and (a)(5).
Section 26.115(a)(1) describes the situation where a donor has presented a specimen that has been reported by an HHS-certified laboratory as adulterated, substituted, or invalid, and the MRO determines that no adequate medical explanation exists for the result and that another specimen should be collected from the donor. An analysis of the NRC's FFD program performance reports for calendar years 2011 through 2014 identified subversion attempts where the HHS-certified laboratory reported an invalid test result for the initial specimen provided by the donor and either the donor refused to provide a second specimen under direct observation or the second specimen collected under direct observation tested positive for a drug. Use of special analyses testing on the second specimen collected would provide additional assurance that drug use would be detected because a period of days would lapse from the point of collection of the initial specimen, testing of that specimen at a laboratory, MRO review of the test results and discussion with the donor, MRO determination that a second specimen should be collected, and the donor appearance at a collection site to provide a second specimen under direct observation.
Section 26.115(a)(2) describes the situation where a donor provides a specimen that falls out of the acceptable temperature range specified in § 26.111(a). Section 26.115(a)(3) describes the situation where donor conduct during the collection process indicates an attempt to dilute, substitute, or adulterate the specimen. An analysis of the NRC's FFD program performance reports for calendar years 2011 through 2014 demonstrates that the majority of subversion attempts are identified based on information obtained during the specimen collection process by the collector (
Section 26.115(a)(5) addresses the situation where the MRO verifies that a specimen is positive, adulterated, or substituted; the donor requests that a retest of the specimen be performed at a second HHS-certified laboratory; but the specimen is not available for testing. As a result, the confirmed test result from the initial testing laboratory must be cancelled by the MRO because the donor was not afforded the opportunity to verify the test results through additional testing at a second HHS-certified laboratory. Use of special analyses testing in this instance would provide additional assurance for the same reason described for specimens collected under § 26.115(a)(1).
The proposed change to require special analyses testing of specimens collected under direct observation would require licensees and other entities to establish an approach for the licensee or other entity to use when notifying a laboratory that special analyses testing is required for a specimen.
Sections 26.4(e)(6)(iv) and 26.31(b)(2) include the statement that “licensees and other entities may rely on a local hospital or other organization that meets the requirements of 49 CFR part 40, `Procedures for Department of Transportation Workplace Drug and Alcohol Testing Programs' (65 FR 41944; August 9, 2001).” Section 26.415(c) also includes a statement that licensees and other entities need not audit “the specimen collection and alcohol testing services that meet the requirements of 49 CFR part 40, `Procedures for Department of Transportation Workplace Drug and Alcohol Testing Programs' (65 FR 41944; August 9, 2001).” The proposed rule would eliminate the
The proposed rule would make a number of revisions to the specimen collection procedures in 10 CFR part 26: (1) Clarify and enhance the instructions on conducting an observed collection, (2) permit the use of mirrors to assist in
Section 26.115(e), (f), and (f)(1) through (f)(3) would be revised to improve the clarity of instruction on conducting a directly observed specimen collection, which would improve consistency with Sections 4.4(a) and 8.9 of the 2008 HHS Guidelines.
The proposed rule would remove the first sentence in § 26.115(f), which states, “If someone other than the collector is to observe the collection, the collector shall instruct the observer to follow the procedures in this paragraph.” The NRC proposes to add the following sentence to the end of the existing requirements in § 26.115(e): “If the observer is not a trained collector, the collector shall, in the presence of the donor, instruct the observer on the collection procedures in paragraph (f) of this section.” The proposed change would improve the clarity of the existing requirements and ensure that the donor is informed that an individual other than the collector is to observe the specimen provision and understands the procedures that must be followed to complete the specimen collection. The proposed change also incorporates feedback received at the October 11, 2011, public meeting, at which a participant suggested using the phrase “who has received instruction” instead of the phrase “who has received training,” when referring to the information that is provided to a same-gender observer by the collector. “Training” implies a formal process rather than providing oral or written instructions. The NRC agrees that the commenter's proposed wording conveys a more accurate description of how the collector would convey the information regarding specimen collection to a same-gender observer. The collector would only be required to give the same-gender observer instructions, rather than formal training.
In § 26.115(f)(2), the proposed rule would add the parenthetical statement “(a mirror may be used to assist in observing the provision of the specimen only if the physical configuration of the room, stall, or private area is not sufficient to meet this direct observation requirement; the use of a video camera to assist in the observation process is not permitted)” to the end of the existing requirement. This proposed change also incorporates stakeholder feedback at the public meeting on October 11, 2011, at which the NRC proposed to prohibit the use of mirrors and video cameras to aid an observer in conducting a directly observed specimen collection, to align with Section 8.9(b) of the 2008 HHS Guidelines. Several industry participants commented that mirrors are currently used at some collection facilities, where the configuration of the stall does not provide adequate space for the collector to directly observe the provision of a specimen from the donor's body into the specimen container. These participants suggested that if the NRC prohibited the use of a mirror to aid in the direct observation process, physical configuration changes at some collection sites would be needed.
Based on subsequent licensee and NRC inspector feedback, the NRC has concluded that the observed collection process in § 26.115(f)(1) continues to ensure that subversion paraphernalia would be identified prior to the provision of a specimen during the observed collection process and that the use of reflective mirrors, not two-way mirrors, would be acceptable. As required by § 26.115(f)(1), prior to conducting the directly observed collection, the donor already must adjust his or her clothing to expose the area between his or her waist and knees. This step ensures that no materials to subvert the testing process (
The NRC also proposes to revise § 26.115(f)(2) to prohibit the use of video cameras to assist in visualizing the provision of a specimen under direct observation. The NRC does not consider a video camera to be an acceptable means of providing direct observation, in part, because the conversion of visible light to an electronic format, through a video camera, is not a direct observation. The use of a video camera for direct observation would be inconsistent with the intent of the rule because the collector or observer would not be in the room or stall with the donor. Further, a video feed is an incomplete source of information because it may not detail the physiological characteristics associated with a subversion attempt and also cannot guarantee the privacy of the donor beyond the individual conducting the observation.
During the public meeting on October 11, 2011, one participant requested that the NRC consider eliminating the requirement in § 26.115(f)(1) that the donor adjust his or her clothing during the observed collection process to expose the area of the donor's body from the waist to the knees. The NRC considered this request but is not proposing to eliminate this provision for three reasons. First, the purpose of directly observing the provision of a specimen is to ensure that the drug testing process is not being subverted. The NRC's collection procedure requires the donor to remove his or her clothing between the waist and knees so that the collector can identify any paraphernalia on the individual's body that may be used to subvert the testing process, such as a prosthetic device, a container of synthetic urine, or ampule of an oxidizing chemical. Second, materials used to subvert a drug test are easily available for purchase, and licensees and other entities have reported in annual performance reports required by § 26.717 that subversion attempts have been identified during the directly observed collection process. Finally, the prevalence of subversion attempts demonstrates that individuals are actively attempting to thwart the drug testing process by specimen adulteration, substitution, and dilution.
In § 26.115(f)(3), the proposed rule would replace the phrase “If the observer is not the collector, the observer may not take the collection container from the donor, but shall observe the specimen as the donor takes it to the collector,” with the phrase “If the observer is not the collector, the observer may not touch or handle the
The proposed rule would add § 26.4(g)(6) and would revise § 26.109(b)(1) to improve the efficiency of FFD programs by providing licensees and other entities with additional flexibility in the personnel who may monitor a donor during the hydration process, which is the 3-hour period of time that is initiated after a donor is unable to provide an acceptable quantity of urine during the initial specimen collection attempt, during which fluid is provided to assist the donor in providing a specimen of adequate volume. In addition to the specimen collector that initiated the specimen collection process with the donor, a staff member designated as FFD program personnel in § 26.4(g) would be allowed to monitor the donor during the hydration process in place of the original collector. All FFD program personnel must meet honesty and integrity requirements in § 26.31(b) and have familiarity with the collection facility, specimen collectors, and 10 CFR part 26 requirements sufficient to monitor the donor during the hydration process. The additional flexibility of collection monitoring provided by the rule change would enable the collector, who initiated the collection process with a donor, to complete additional specimen collections with other donors while the initial donor hydrates. Another specimen collector, who meets the requirements in § 26.85(a), could also monitor the donor in the hydration process. The proposed change could reduce the regulatory burden on FFD programs by affording licensees and other entities additional staffing options to better manage the collection process, while maintaining appropriate oversight of the collection process. If a hydration monitor or another collector is used, the original collector would be required to note the name of the individual on the Federal CCF and the hydration monitor or second collector then would maintain control of the Federal CCF during the observation process (
The proposed rule would revise § 26.89(d) in three ways. First, § 26.89(d) would be revised to clarify that a collector shall conduct only one collection procedure at any given time, except in the instance when another collector who meets the requirements in § 26.85(a) or a hydration monitor is observing the donor during the hydration process, as permitted by the proposed change to § 26.109(b)(1). Second, § 26.89(d) would be revised to more precisely describe the actions taken by the collector when sealing the collection container with tamper-evident tape and completing the Federal CCF to end the collection process. The phrase “the urine specimen container has been sealed and initialed, the chain of custody form has been executed, and the donor has departed the collection site” would be replaced with the phrase “the urine specimen container has been sealed with tamper-evident tape, the seal has been dated and initialed, and the Federal CCF has been completed.” Third, the phrase “or when a refusal to test has been determined under § 26.107(d)” would be added to § 26.89(d) to more accurately describe when the collection process has been completed if a refusal to test has been determined. The three changes would improve the clarity of the existing collection requirements, correct an editorial error in the name of the form that is used to document the specimen collection, and include a reference to a refusal to test as another circumstance when the collection process is complete.
The proposed rule would revise § 26.107, “Collecting a urine specimen,” in four ways related to how the donor is observed. First, the proposed rule would redesignate paragraph (b) as paragraph (b)(1) of this section. Second, the phrase “, except as provided in § 26.109(b)(1),” would be added in the first sentence after “The collector shall pay careful attention to the donor during the entire collection process.” This revision is necessary because of the proposed rule change to permit an individual other than the original specimen collector to monitor a donor in the hydration process; as a result, the original collector may not be present with the donor during the entire collection process. Third, § 26.107(b)(1) would be revised to replace the phrase “to note any conduct that clearly indicates an attempt to tamper with a specimen (
Section 26.107(b)(2) would be added to ensure that if a hydration monitor is used to observe a donor during the § 26.109(b) hydration process, this individual would immediately inform the collector of any donor conduct that may indicate an attempt to subvert the testing process, such as the donor leaving the collection site or refusing to follow directions. This rule change would be necessary because the collector must be informed of any unacceptable donor behavior so that appropriate action may be taken.
The proposed rule would revise § 26.89(c) to correct an editorial error in the instructions that a collector must provide to the donor regarding refusing to cooperate with the testing process. Currently, the word “adulterated” is used twice in the phrase “adulterated, diluted, or adulterated the specimen,” which describes the situation where a donor admits to subverting the testing process. The phrase would be revised to “adulterated, diluted, or substituted the specimen.”
The proposed rule would revise § 26.117, “Preparing urine specimens
With regard to urine specimen acceptability, the proposed rule would revise the term “altered,” as used in § 26.111(a) and (c), to clarify that the term means that the collector has determined that a specimen may have been adulterated and/or diluted. This determination by a collector is not equivalent to the determination that a specimen is an
The proposed rule would correct an editorial error in § 26.111(a) associated with the minimum volume requirement for a urine specimen. Specifically, the phrase “but greater than 15 mL” would be replaced with “but equal to or greater than 15 mL.” This change conforms with the existing minimum specimen volume requirements in §§ 26.109(b)(4) and 26.111(b) and (d).
The proposed rule would add § 26.107(d) and revise §§ 26.111(c) and (e) and 26.115(g) to more explicitly describe the actions that a collector must take when a refusal to test is determined during the specimen collection process, including the retention or disposal of any specimen(s) provided by the donor.
Section 26.107(d) would be added to state that if the collector determines a refusal to test during the specimen collection process, the collector shall do the following: (1) Inform the donor that a refusal to test has been determined; (2) terminate the collection process; (3) document a description of the refusal to test on the Federal CCF; (4) discard any urine specimen(s) provided by the donor, unless provided for a post-event test in § 26.31(c)(3); and (5) immediately inform the FFD program manager of the refusal to test. The majority of these proposed changes are consistent with existing collector practice. However, the proposed change to discard any urine specimens, except if collected for a post-event test, would be a new requirement to improve the uniformity of licensee and other entity actions taken once a refusal to test had been determined. The NRC is aware of instances in which a licensee or other entity would conduct specimen testing, even though a refusal to test had already been determined at the collection site. This change would address this inconsistency. The proposed revisions to § 26.107(d) would help ensure that if a donor refuses to cooperate with the collection process, uniform action is taken, which would make 10 CFR part 26 consistent with Section 8.12 of the 2008 HHS Guidelines and improve its effectiveness.
The proposed change to retain and test any specimen collected for a post-event test in § 26.31(c)(3) would help to inform licensee root cause determinations, as required by other parts of the NRC's regulations, such as §§ 20.2203(b), 50.73(b), and 70.50(c). Although a refusal to test determination at the collection site subsequent to a specimen being provided for a post-event test is a very rare occurrence, a regulatory framework is needed to enable the testing of an individual's urine (or other specimen matrix such as oral fluid) to assist in determining whether the individual who committed or contributed to the event may have been impaired from the use of alcohol, an illegal drug, or prescription or over-the-counter medication. This assessment (which is informed by the requirements in §§ 26.185, “Determining a fitness-for-duty policy violation” and 26.189, “Determination of fitness”) is very important because post-event testing is conducted, in part, in response to the occurrence of a very significant event such as, but not limited to: (1) A death, (2) a significant illness or personal injury, (3) a radiation exposure or release of radioactivity in excess of regulatory limits, or (4) an actual or potential substantial degradation of the level of safety of the plant.
Section 26.111(c) would be revised to remove the word “designated” from the phrase “designated FFD program manager.” This proposed change conforms with the existing terminology used in §§ 26.105(b), 26.109(b)(3), 26.111(c), 26.115(a), (b), and (h), and 26.139(b).
Section 26.111(e) specifies that “as much of the suspect specimen as possible must be preserved.” The proposed rule would add the clarifying phrase “except under the conditions described in § 26.107(d)(4)” to reference the conditions when a collector is to discard any urine specimen(s) collected. This change aligns with the proposed changes to § 26.107(d).
Some participants at the public meeting on October 11, 2011, requested that the NRC consider eliminating § 26.111(f) because they believe this particular requirement is unnecessary. Section 26.111(f) defines the criteria for an acceptable urine specimen as free from apparent contaminants, of at least 30 mL in quantity, and within the acceptable temperature range. However, this requirement does not aid in the implementation of 10 CFR part 26 and is not used in the NRC's drug testing requirements. The participants stated that this provision is unnecessary because other sections in 10 CFR part 26 require specimens that do not meet the criteria in § 26.111(f) to be sent to an HHS-certified laboratory for testing. The NRC agrees that this requirement is unnecessary because other sections in the rule already provide explicit detail as to the determination of whether a specimen is valid or invalid, as well as the specific steps required if either determination is made. Section 26.109, “Urine specimen quantity,” contains provisions regarding urine specimen quantity; § 26.111(a) contains provisions regarding specimen temperature; and § 26.111(d) requires that any specimen a collector suspects has been adulterated, diluted, substituted, or that is collected under direct observation must be sent to an HHS-certified laboratory for initial and, if necessary, confirmatory testing. Therefore, the NRC is proposing to remove § 26.111(f) to improve the clarity of 10 CFR part 26.
Section 26.115(g) states that a donor declining to allow a directly observed collection is an act to subvert the testing process. The proposed rule would include a new requirement that in this instance “the collector shall follow the procedures in § 26.107(d).” This proposed requirement describes the
The NRC also received a public comment regarding the retention or disposal of a urine specimen. The commenter recommended that the initially collected specimen be retained, unless the MRO or FFD program manager determined that a directly observed collection was necessary and the donor refused to comply, which the NRC interpreted as a reference to § 26.111(c) of the regulations. Section 26.111(c) requires the collector to contact the FFD program manager if there is reason to believe that a donor may have attempted to adulterate, dilute, or substitute a specimen based on the physical characteristics of a specimen (
The proposed rule would revise § 26.168(h)(1), which currently requires blind performance test sample (BPTS) suppliers to place a sample lot in service for no more than 6 months. Feedback received from industry and BPTS suppliers indicates that sample lots can remain viable for much longer than 6 months (
The proposed rule would remove § 26.155, “Laboratory personnel,” which re-states the qualifications and responsibilities of HHS-certified laboratory personnel (
A conforming change based on the removal of § 26.155 would be to eliminate the reference to § 26.155 in § 26.8, “Information collection requirements; OMB approval,” which lists the information collection requirements in 10 CFR part 26 that were approved by the Office of Management and Budget (OMB).
The proposed rule would remove § 26.157(b) through (e), which re-state the laboratory procedures requirements included in the HHS Guidelines. Section 26.157, “Procedures,” describes the written procedures that HHS-certified laboratories must develop, implement, and maintain. The NRC finds that it is unnecessary to restate these HHS Guidelines requirements in 10 CFR part 26 because licensees and other entities are required to use HHS-certified laboratories to conduct drug and validity testing in § 26.153(a). As discussed for the proposed changes to § 26.155, each HHS-certified laboratory is certified and then inspected on a periodic basis by the NLCP, which provides assurance that the procedures requirements in the HHS Guidelines are developed, implemented, and maintained by the laboratory. The proposed change would reduce the potential for dual regulation of HHS-certified laboratories with respect to maintaining a duplicative set of laboratory procedures already required to be maintained by the HHS Guidelines and reviewed and evaluated by the NLCP.
The proposed rule would revise § 26.157(a) to replace the phrase “develop, implement, and maintain clear and well-documented procedures for accession, receipt, shipment, and testing of urine specimens” with “develop, implement, and maintain procedures specific to this part that document the accession, receipt, shipment, and testing of specimens.” The proposed changes would do the following: (1) Ensure that each laboratory would continue to maintain procedures specific to 10 CFR part 26, such as for special analyses testing in § 26.163(a) and the use of more stringent testing cutoff levels and/or the testing of additional substances permitted in § 26.31(d)(3); (2) remove the word “urine” from the phrase “testing of urine specimens” to provide additional flexibility, should the testing of additional specimen matrices (
Section 26.137(e)(6) lists the specifications for the quality control samples to be included in each
The proposed rule would replace the word “drugs” in the first sentence of § 26.137(e)(6) and the phrase “drug and metabolite” in the second sentence of § 26.137(e)(6) with “drugs and drug metabolites” and “drug and drug metabolite,” respectively. The phrases “drug(s) or drug metabolite(s)” in § 26.137(e)(6)(ii) and (e)(6)(iii) and “a drug(s) or drug metabolite(s)” in § 26.167(d)(3)(ii), (d)(3)(iii), and (e)(3)(iii) would be replaced with the phrase “the drug or drug metabolite.” Similarly, the phrase “no drug” would be expanded to “no drug or drug metabolite” in § 26.167(e)(3)(i), and the phrase “no drugs or drug metabolites” would be revised to “no drug or drug metabolite” in §§ 26.137(e)(6)(i) and 26.167(d)(3)(i).
The proposed rule would remove the parenthetical phrase “(
The phrase “targeted at 25 percent below the cutoff” would be replaced in the proposed rule with the phrase “targeted at 75 percent of the cutoff” in §§ 26.137(e)(6)(iii) and 26.167(d)(3)(iii).
The term “sample(s)” would be replaced in the proposed rule with the phrase “at least one control” in §§ 26.137(e)(6)(i) and 26.167(d)(3)(i) and (e)(3)(i). Similarly, the phrase “at least one calibrator or control that is” would be replaced in the proposed rule with the phrase “at least one control” in § 26.167(e)(3)(iv).
The parenthetical statement “(
The phrase “Positive calibrator(s) and control(s) with a drug(s) or drug metabolite(s)” in § 26.167(e)(3)(ii) would be replaced in the proposed rule with the phrase “A calibrator with its drug concentration at the cutoff.”
The proposed rule would replace the phrase “A minimum of 10 percent of all specimens in each analytical run” in § 26.137(e)(6) with the phrase “A minimum of 10 percent of the total specimens in each analytical run,” to more clearly describe how to determine the number of quality control samples to include in each analytical run of initial drug testing performed at an LTF. Conforming changes would be made in § 26.167(e)(2) to the quality control samples that are to be included in each analytical run of confirmatory drug tests performed at an HHS-certified laboratory, by replacing the phrase “At least 10 percent of the samples in each analytical run of specimens” with the phrase “A minimum of 10 percent of the total specimens in each analytical run.” The proposed change to § 26.167(e)(2) is consistent with the existing terminology used in the quality control sample requirement for initial drug testing in § 26.167(d)(4).
Section 26.167(f)(3) would be revised to make an editorial correction to the phrase “a statement by the laboratory's responsible person” by capitalizing the “r” and the “p” in the position title, so that it reads as follows: “Responsible Person.”
The proposed rule would also correct two of three inaccuracies described in an NRC enforcement guidance memorandum (EGM-09-003, dated March 31, 2009) that pertain to the LTF quality control sample requirements for initial validity testing in § 26.137(d)(5) and for initial drug testing in § 26.137(e)(6)(v). The third inaccuracy, incorrectly using the term “laboratory analysts” instead of “licensee testing facility technicians,” has already been addressed in a 10 CFR part 26 final rule correcting amendment, which was published in the
The first inaccuracy pertains to the requirements in § 26.137(d)(5) and (e)(6)(v), which require that at least one quality control specimen in each analytical run must appear as a “donor specimen” instead of as a “normal specimen” to the LTF technician. To meet this requirement, a different individual would be required to prepare the quality control sample to ensure that the LTF technician that is conducting the specimen testing would be unaware of the origin of the sample. The current rule does not require that different individuals prepare quality control samples and conduct specimen testing. Without EGM-09-003, § 26.137(d)(5) and (e)(6)(v) would place an unnecessary burden on licensees and other entities because additional LTF procedural changes would be necessary, including the use of an additional qualified person, either to prepare quality control samples or to conduct specimen testing. The majority of LTFs use a single LTF technician to prepare quality control samples and to perform specimen testing, which is consistent with the intent of the current rule. To correct this inaccuracy and to address the currently applicable enforcement discretion, the proposed rule would replace the phrase “donor specimen” with the phrase “normal specimen” in § 26.137(d)(5) and (e)(6)(v).
The second inaccuracy pertains to the requirement in § 26.137(e)(6)(v) that “at least one positive control” is to be included in each analytical run of initial drug testing of specimens at an LTF. The intent of this requirement is to verify the custody and control procedures and confirm the accuracy of initial drug testing performed at an LTF, neither of which require the use of only a positive quality control sample. Since § 26.137(e)(6)(ii) and (e)(6)(iii) already specify the positive quality control samples to be included in each analytical run, the proposed rule would replace the phrase “at least one positive control, certified to be positive by an HHS-certified laboratory” with the phrase “at least one quality control sample” in § 26.137(e)(6)(v).
The NRC would rescind EGM-09-003 if the proposed rule changes correcting these inaccuracies are finalized.
Section 26.185(f) describes the process that an MRO is to use to review invalid specimen test results. The proposed rule would redesignate paragraph (f)(3) as paragraph (f)(4) and would add a new paragraph (f)(3) to § 26.185, to align the MRO review process for invalid specimen test results with Section 13.4(f) of the 2008 HHS Guidelines. Specifically, if a donor did not provide an acceptable medical explanation to the MRO for a pH value in the range of 9.0 to 9.5, the MRO would then have to consider if elapsed time and/or high temperature might have caused the test result. This change is being proposed because of research that demonstrated that exposing a urine specimen to high temperature and/or an extended delay in specimen testing from the time of collection may result in a pH in the range of 9.0 to 9.5 (Cook, et al., 2007). The 2008 HHS Guidelines addressed this topic in Section 13.4(f). In the proposed rule, if the MRO obtains sufficient information from the licensee
Based on feedback received during the October 11, 2011, public meeting, the NRC has chosen not to propose adding detailed instructions in 10 CFR part 26 on how the MRO is to interpret time and temperature information with respect to specimen pH. Meeting participants commented that the draft instructions presented by the NRC at the public meeting were too prescriptive and unnecessary and that the MRO should be provided with flexibility in making this determination. The NRC agreed and instead is proposing to include guidance on the methods an MRO could use to review invalid test results reported in § 26.185(f)(3) in draft regulatory guide (DG) 5040, “Urine Specimen Collection and Test Result Review under 10 CFR part 26, Fitness for Duty Programs.” This draft guidance is being issued concurrently for comment with this proposed rule.
The NRC also discussed at the October 11, 2011, public meeting the potential to change § 26.131(b)(2) to assist in the documentation of time and/or temperature information for invalid test results, based on a pH of 9.0 or greater obtained at an LTF. However, participants opposed these documentation requirements because they would be burdensome to implement. The NRC agreed and instead is proposing to include in DG-5040 the methods that LTF staff may use to document information to support the MRO review of invalid test results in § 26.185(f)(3).
Section 26.165(b)(2) instructs the MRO to “inform the donor that he or she may, within 3 business days of notification by the MRO of the confirmed positive, adulterated, or substituted test result, request the retesting of an aliquot of the single specimen or the testing of the Bottle B split specimen.”
Section 26.165(b)(3) requires the donor to provide his or her permission for the retesting of an aliquot of the single specimen or the testing of Bottle B and states that “Neither the licensee, MRO, NRC, nor any other entity may order retesting of the single specimen or testing of the specimen in Bottle B without the donor's written permission, except as permitted in § 26.185(l).” The proposed rule would revise § 26.165(b)(3) to state that “No entity, other than the MRO as permitted in § 26.185(l), may order the retesting of an aliquot of a single specimen or the testing of the Bottle B split specimen.” The proposed change would address an inconsistency in the current rule because § 26.165(b)(2) already states that the “donor's request may be oral or in writing.” At present, even though the MRO may have received an oral request from the donor to proceed with the retesting of an aliquot of a single specimen or to test the Bottle B split specimen, some licensees are interpreting the current rule to require that the MRO must receive written permission from the donor before initiating the retesting of a specimen.
These proposed changes to § 26.165(b)(2) and (b)(3) would improve the consistency of 10 CFR part 26 with Section 14.1(b) of the 2008 HHS Guidelines and would enhance due process by ensuring that the retesting of an aliquot of a single specimen or the testing of the Bottle B split specimen could proceed as quickly as possible.
Section 26.115(a) lists the exclusive grounds for collecting a urine specimen under direct observation. However, the list does not include an existing requirement in § 26.165(f)(2) in which an observed collection is required when a donor requests a retest and either Bottle B or the single specimen is not available, due to circumstances outside of the donor's control. The proposed rule would correct this omission by including a new paragraph (a)(5) to reference the direct observation requirement in § 26.165(f)(2).
Section 26.165(f)(2) requires MRO action for a positive drug test result or an adulterated or substituted validity test result when the Bottle B of a split specimen or an aliquot of a single specimen is not available for testing at the donor's request. In this instance, the MRO is required to cancel the initial test result and inform the licensee or other entity that a second specimen must be collected under direct observation “as soon as reasonably practical.” Section 14.1(c) of the 2008 HHS Guidelines, for this same circumstance, states that no advanced notice is to be provided to the donor regarding the second specimen collection until immediately before the collection is to commence. The proposed rule would revise the requirement in § 26.165(f)(2) to specify that no prior notice shall be given to a donor until immediately before the collection. Clarifying the procedure to follow in this circumstance would improve the effectiveness of licensees' or other entities' testing programs to detect illegal drug use and/or the misuse of legal drugs and would align 10 CFR part 26 with the 2008 HHS Guidelines.
The proposed rule would also revise § 26.165(f)(2) to state that the MRO is to report a cancelled test result to the licensee or other entity. The process in § 26.165(f)(2) already states that the licensee or other entity may not impose any sanctions on the donor for a cancelled test result. This revision clarifies the existing action that the MRO must take to report the results of the testing of a donor's specimen to the licensee or other entity. Subsequent
A participant at the October 11, 2011, public meeting also requested that the NRC include in § 26.165(f)(2) a reference to §§ 26.129(b)(2) and 26.159(b)(2) to clarify that the action of the licensee or other entity was taken based on the test results of the second specimen collected under direct observation. The NRC agrees with this request and is proposing to revise this section accordingly.
The NRC has periodically received questions from licensees and other entities on the annual drug and alcohol testing reporting requirements on “populations tested” in § 26.717(b) and (c). Specifically, the reporting requirements to provide FFD program performance data by populations tested “(
First, licensees already report the pre-access testing results separately for the licensee employee and C/V tested populations, so they requested clarification on the term “individuals in applicant status.” Applicant status is not a distinct tested population category, rather, it is the status of individuals that are subject to pre-access testing. Currently, licensees and other entities must report the test results by tested population for each condition of testing (
Second, the NRC has received questions from entities other than the licensees that report § 26.717 drug and alcohol test results. Because § 26.717(b)(3) and (b)(4) does not specify “other entity” in the parenthetical statements defining the tested populations, these entities were unclear on how to classify their tested populations on the § 26.717 annual summary reports to the NRC. To correct this oversight, the proposed rule would revise the tested population “licensee employees” to “licensee or other entity employees” in § 26.717(b)(3) and (b)(4).
Throughout 10 CFR part 26, the NRC is proposing to revise the term “custody and control form” to read “Federal CCF.” Two additional iterations of the term, “custody-and-control forms” and “custody-and-control form(s),” would also be revised to read “Federal CCFs” and “Federal CCF(s),” respectively.
Throughout 10 CFR part 26, the NRC is proposing to revise the term “chain-of-custody” to read “chain of custody.”
The nomenclature changes to “custody-and-control form” and “chain-of-custody” would align with the spelling of these terms in the 2008 HHS Guidelines and would also improve consistency in 10 CFR part 26.
The proposed rule would also correct a number of instances where “chain-of-custody form” was used instead of “custody and control form,” and vice versa. These corrections pertain to §§ 26.89(d); 26.117(f); and 26.159(c), (d) and (e), as described later in this section.
Section 26.4(e)(6)(iv) would be revised to eliminate the phrase “(65 FR 41944; August 9, 2001).”
Section 26.4(g)(6) would be added to describe a new activity that the FFD program personnel could perform: Monitoring a donor during the hydration process described in § 26.109(b). The punctuation at the end of § 26.4(g)(4) and (5) would be updated to accommodate the addition of § 26.4(g)(6).
Section 26.4(j)(3) would be revised to replace the phrase “laboratory certified by the Department of Health and Human Services (HHS)” with “Department of Health and Human Services (HHS)-certified laboratory as defined in § 26.5.”
As described in Section III.C of this document, the NRC is proposing to add definitions for
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Section 26.8(b) would be revised to remove the reference to § 26.155.
Section 26.31(b)(2) would be revised to eliminate the phrase “(65 FR 41944; August 9, 2001).”
Section 26.31(d)(1) would be revised to include MDMA and MDA as substances for which licensees and other entities are required to test in each specimen.
Section 26.31(d)(1)(i)(D) would be revised to eliminate the phrase “as specified in § 26.155(a).”
Section 26.31(d)(1)(ii) would be revised to replace the phrase “except if the specimen is dilute and the licensee or other entity has required the HHS-certified laboratory to evaluate the specimen in §§ 26.163(a)(2) or 26.168(g)(3) with the phrase “except if special analyses of the specimen is performed under § 26.163(a)(2) by the HHS-certified laboratory.”
Section 26.89(c) would be revised to replace the phrase “adulterated, diluted, or adulterated the specimen” with the phrase “adulterated, diluted, or substituted the specimen.”
Section 26.89(d) would be revised to include this phrase at the end of the first sentence: “, except as described in § 26.109(b)(1).” The second sentence in § 26.89(d) would be revised in three ways. First, the phrase “For this purpose, a urine collection” would be replaced with the phrase “The urine collection.” Second, the phrase “sealed and initialed” would be replaced with the phrase “sealed with tamper-evident tape, the seal has been dated and initialed.” Finally, the phrase “the chain of custody form has been executed, and the donor has departed the collection site” would be replaced with the phrase “and the Federal CCF has been completed or when a refusal to test has been determined under § 26.107(d).”
Section 26.107(b) would be revised in four ways. First, the proposed rule would redesignate paragraph (b) as paragraph (b)(1) of this section. Secondly, the phrase “except as provided in § 26.109(b)(1)” would be added in the first sentence after “The collector shall pay careful attention to the donor during the entire collection process.” Third, § 26.107(b) would be revised to replace the phrase “to note any conduct that clearly indicates an attempt to tamper with a specimen (
Section 26.107(b)(2) would be added to ensure that if a hydration monitor is used to observe a donor during the § 26.109(b) hydration process, this individual shall immediately inform the collector of any donor conduct that may indicate an attempt to subvert the testing process (
Section 26.107(d) and (d)(1) through (d)(5) would be added to describe requirements regarding the actions a collector must take if a refusal to test is determined at any point during the specimen collection process. Specifically, the collector shall: (1) Inform the donor that a refusal to test has been determined, (2) terminate the collection process, (3) document a description of the refusal to test on the Federal CCF, (4) discard any urine specimen(s) provided by the donor unless the specimen was collected for a post-event test required by § 26.31(c)(3), and (5) immediately inform the FFD program manager of the refusal to test.
Section 26.109(b)(1) would be revised, and new paragraphs (b)(1)(i) through (b)(1)(iii) would be added to provide a licensee or other entity with new flexibility in the personnel that may be used to monitor a donor during the hydration process that is initiated when a donor is unable to provide an acceptable quantity of urine during the initial collection attempt. For clarity, the last sentence of § 26.109(b)(1) would become the new first sentence of § 26.109(b)(2). The proposed rule would permit another staff member designated as FFD program personnel, as described in § 26.4(g)(6), or another specimen collector meeting the requirements in § 26.85(a), instead of the specimen collector who initiated the collection process, to monitor a donor during the hydration process. The collector shall (1) explain the hydration process and acceptable donor behavior to the hydration monitor and (2) record the name of the individual observing the donor on the Federal CCF and then provide the Federal CCF to the observer for the duration of the hydration process. The original collector may then perform other collections while the donor is in the hydration process.
Section 26.111(a) would be revised to replace the phrase “greater than 15 mL” with the phrase “equal to or greater than 15 mL” and to add the phrase “(
Section 26.111(c) would be revised to remove the word “designated” from the phrase “designated FFD program manager” in the first sentence. The parenthetical phrase “(
Section 26.111(e) would be revised to include the phrase “, except under the conditions described in § 26.107(d)(4)” at the end of the existing requirement.
Section 26.111(f) would be removed.
Section 26.115(a)(3) would be revised to replace the phase “The collector observes conduct clearly and unequivocally indicating an attempt to dilute, substitute, or adulterate the specimen” with the phrase “The collector, or the hydration monitor if one is used as permitted in § 26.109(b)(1), observes conduct by the donor indicating an attempt to subvert the testing process.” Also, the proposed rule would remove the word “and” at
In § 26.115(f), the proposed rule would revise the first sentence, “If someone other than the collector is to observe the collection, the collector shall instruct the observer to follow the procedures in this paragraph,” so that it reads “If the observer is not a trained collector, the collector shall, in the presence of the donor, instruct the observer on the collection procedures in paragraph (f) of this section.” The revised sentence would be added to the end of existing requirements in § 26.115(e).
In § 26.115(f)(2), the proposed rule would add the following statement to the end of the existing requirement: “A reflective mirror may be used to assist in observing the provision of the specimen only if the physical configuration of the room, stall, or private area is not sufficient to meet this direct observation requirement; the use of a video camera to assist in the observation process is not permitted.”
In § 26.115(f)(3), the proposed rule would replace the phrase “If the observer is not the collector, the observer may not take the collection container from the donor, but shall observe the specimen as the donor takes it to the collector” with the phrase “If the observer is not the collector, the observer may not touch or handle the collection container but shall maintain visual contact with the specimen until the donor hands the collection container to the collector.”
Section 26.115(g) would be revised to include the phrase “, and the collector shall follow the procedures in § 26.107(d)” at the end of the existing requirement.
Section 26.117(a) would be revised to add the phrase “Once the collector is presented with the specimen from the donor” at the beginning of the first sentence to clarify when the collector would begin to keep the donor's “urine specimen(s) in view at all times.”
Section 26.117(f) would be revised to replace the term “chain-of-custody forms” with the term “Federal CCFs.” Section 26.117(f) would also be revised to replace the phrase “or the licensee's testing facility,” with the phrase “or to the licensee testing facility.”
Section 26.117(g) would be revised to add the phrase “, except as provided in § 26.109(b)(1)(ii) for the Federal CCF,” to the end of the first sentence.
Section 26.129(b)(1)(ii) would be revised by replacing the phrase “the specimen may not be tested,” with the phrase “the licensee testing facility shall reject the specimen for testing.”
Section 26.129(b)(2) would be revised by adding the phrase “and report a cancelled test result to the licensee or other entity,” after the phrase “requiring the MRO to cancel the testing of a donor's urine specimen.”
The introductory paragraph under § 26.133 would be revised to clarify that the specified cutoff level must be used to determine whether the specimen is negative “or positive” for the indicated drug or drug metabolite being tested. The table in § 26.133 would be revised to: (1) Lower the initial test cutoff level for cocaine metabolites from 300 ng/mL to 150 ng/mL, (2) include a new footnote 1 to clarify that the initial test cutoff level for opiate metabolites is for codeine/morphine and that morphine is the target analyte, (3) lower the initial test cutoff level for amphetamines (abbreviated in the table as AMP) from 1000 ng/mL to 500 ng/mL, (4) add initial testing for 6-AM at a cutoff level of 10 ng/mL, (5) include a new table footnote 2 regarding initial test kits, (6) include a new table footnote 3 to clarify that for amphetamines testing, methamphetamine (abbreviated in the table as MAMP) is the target analyte, (7) add initial testing for MDMA and MDA at a cutoff level of 500 ng/mL, and (8) provide the full chemical name for MDMA and MDA in new footnotes 4 and 5 to the table, respectively. The column header “Drug or metabolites” in the table in § 26.133 would also be revised to “Drugs or drug metabolites” to align with the table title.
Section 26.137(d)(5) would be revised to replace the term “donor specimen” with the term “normal specimen.”
Section 26.137(e)(6) would replace the phrase “A minimum of 10 percent of all specimens” at the start of the first sentence with the phrase “A minimum of 10 percent of the total specimens.” The parenthetical phrase “(
Section 26.137(e)(6)(i) would replace the phrase “Sample(s) certified by an HHS-certified laboratory to contain no drugs or drug metabolites (
Section 26.137(e)(6)(ii) would be revised to replace the phrase “drug(s) or drug metabolite(s)” with the phrase “the drug or drug metabolite.”
Section 26.137(e)(6)(iii) would be revised to replace the phrase “the drug(s) or drug metabolite(s) targeted at 25 percent below the cutoff” with the phrase “the drug or drug metabolite targeted at 75 percent of the cutoff.”
Section 26.137(e)(6)(v) would be revised to replace the phrase “At least one positive control, certified to be positive by an HHS-certified laboratory, which appears to be a donor specimen” with the phrase “At least one quality control sample that appears to be a normal specimen.”
Section 26.153(a) would be revised to replace the phrase “laboratories certified under the Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs [published in the
Section 26.153(g) would be revised to replace the term “Federal custody-and-control form” with “Federal CCF” and the term “non-Federal form” with “non-Federal CCF.”
Section 26.155 would be removed and reserved.
Section 26.157(a) would be revised to replace the phrase “clear and well-documented procedures for” with the phrase “procedures specific to this part that document the.” Section 26.157(a) would also be revised to remove “urine” in the phrase “testing of urine specimens.”
Section 26.157(b) would be removed and reserved, and § 26.157(c) through (e) would be removed.
Section 26.159(b)(1)(ii) would be revised to replace the phrase “the specimens may not be tested” with the phrase “the laboratory shall reject the specimens for testing” when the integrity or identity of the specimens is in question.
Section 26.159(b)(2) would be revised to add after “The following are exclusive grounds requiring the MRO to cancel the testing of a donor's urine specimen,” the phrase “and report a cancelled test to the licensee or other entity.”
Section 26.159(c) would be revised in the second sentence of the paragraph to replace the term “custody-and-control” with the term “chain of custody.” Also, the term “custody-and-control form” would be replaced with the term “Federal CCF” in the third sentence of the paragraph.
Section 26.159(d) would be revised to replace the term “custody-and-control” with the term “chain of custody.”
Section 26.159(e) would be revised to replace the term “custody-and-control” with the term “chain of custody” in the two instances that it occurs in the paragraph.
Sections 26.161(c)(3) through (c)(6) would be revised to replace all instances of “LOD” with “LOQ.”
Sections 26.161(c)(5) would be revised to replace the phrase “GC/MS for the confirmatory test” with the phrase “a different confirmatory method (
Sections 26.161(c)(6) would be revised to replace the phrase “GC/MS for the confirmatory test” with the phrase “a different confirmatory method (
Sections 26.161(f)(5) and (f)(7) would be revised to replace all instances of the term “LOD” with the term “LOQ.”
Section 26.163(a)(1) would be revised to replace the phrase “negative for the indicated drugs and drug metabolites” with the phrase “negative or positive for the indicated drugs and drug metabolites.” The phrase “except if validity testing indicates that the specimen is dilute” would also be revised to “except as specified in paragraph (a)(2) of this section.”
The table in § 26.163(a)(1) would be revised to: (1) Lower the initial test cutoff level for cocaine metabolites from 300 ng/mL to 150 ng/mL, (2) include a new footnote 1 to clarify that the initial test cutoff level for opiate metabolites is for codeine/morphine and that morphine is the target analyte, (3) lower the initial test cutoff level for amphetamines (abbreviated in the table as AMP) from 1000 ng/mL to 500 ng/mL, (4) add initial testing for 6-AM at a cutoff level of 10 ng/mL, (5) include a new footnote 2 regarding initial test kits, (6) include a new footnote 3 to clarify that for amphetamines testing, methamphetamine (abbreviated in the table as MAMP) is the target analyte, (7) add initial testing for MDMA and MDA at a cutoff level of 500 ng/mL, and (8) provide the full chemical names for MDMA and MDA in new footnotes 4 and 5 to the table, respectively. The column header “Drug or metabolites” in the table in § 26.163(a)(1) would also be revised to “Drugs or drug metabolites” to align with the table title. Section 26.163(a)(2) would be revised to remove the phrase “At the licensee's or other entity's discretion, as documented in the FFD program policies and procedures, the licensee or other entity may require the” and replace the provision with “HHS-certified laboratories shall conduct special analyses of specimens as follows:.”
Section 26.163(a)(2)(i) would be revised to replace the phrase “the HHS-certified laboratory shall compare the responses of the dilute specimen to the cutoff calibrator in each of the drug classes” with the phrase “or if a specimen is collected under direct observation for any of the conditions specified in § 26.115(a)(1) through (a)(3) or (a)(5).”
Section 26.163(a)(2)(ii) would be revised to state “If any immunoassay response is equal to or greater than 40 percent of the cutoff calibrator, the laboratory shall conduct confirmatory drug testing of the specimen to the LOQ for those drugs and/or drug metabolites; and.”
The table in § 26.163(b)(1) would be revised to: (1) Lower the confirmatory test cutoff level for cocaine metabolite from 150 ng/mL to 100 ng/mL, (2) revise “Opiates” to read “Opiate metabolites,” (3) remove footnote 3 regarding the requirement that confirmatory testing of 6-AM only proceed when confirmatory testing shows a morphine concentration exceeding 2000 ng/mL, (4) lower the confirmatory test cutoff levels for amphetamine and methamphetamine from 500 ng/mL to 250 ng/mL, (5) redesignate footnote 4 as footnote 3 and revise the text to lower the concentration of amphetamine that must be present in the specimen from 200 ng/mL to 100 ng/mL, and (6) add confirmatory testing for MDMA and MDA at a cutoff level of 250 ng/mL. The column header “Drug or metabolites” in the table in § 26.163(b)(1) would also be revised to “Drugs or drug metabolites.”
A new fifth sentence would be added to § 26.165(b)(2) that states, “The MRO shall document in his or her records when (
The first sentence in § 26.165(b)(3) would be deleted. The second sentence in § 26.165(b)(3) would be revised to state “No entity, other than the MRO as permitted in § 26.185(l), may order the retesting of an aliquot of a single specimen or the testing of the Bottle B split specimen.”
The last sentence in § 26.165(f)(1) would be revised by adding the phrase “the MRO shall report a cancelled test result to the licensee or other entity, and” to indicate that the MRO must report the cancelled test.
Section 26.165(f)(2) would be revised to clarify the actions that an MRO is to take when a donor requests testing of Bottle B or a retest of a single specimen and the specimen to be tested is unavailable due to circumstances outside of the donor's control. Specifically, the proposed rule would: (1) Add instruction for the MRO to report a cancelled test to the licensee or other entity for the donor's specimen; (2) add instruction for the licensee or other entity to perform a second collection without prior notice to the donor and to continue to administratively withdraw the individual's authorization until the results of the second collection are received by the MRO; and (3) add a reference to §§ 26.129(b)(2) and 26.159(b)(2), which describes the circumstances that require the MRO to cancel a test result.
Section 26.167(d)(3)(i) would be revised to replace the phrase “Sample(s) certified to contain no drugs or drug metabolites (
Section 26.167(d)(3)(ii) would be revised to replace the phrase “a drug(s) or drug metabolites” with the phrase “the drug or drug metabolite.”
Section 26.167(d)(3)(iii) would be revised to replace the phrase “a drug(s) or drug metabolite(s) targeted at 25 percent below the cutoff” with the phrase “the drug or drug metabolite targeted at 75 percent of the cutoff.”
Section 26.167(d)(4) would be revised to add the parenthetical statement “(
Section 26.167(e)(2) would be revised to replace the phrase “At least 10 percent of the samples in each analytical run of specimens must be calibrators and controls” with the phrase “A minimum of 10 percent of the total specimens in each analytical run must be quality control samples (
Section 26.167(e)(3)(i) would be revised to replace the phrase “Sample(s) certified to contain no drug (
Section 26.167(e)(3)(ii) would be revised to replace the phrase “Positive calibrator(s) and control(s) with a drug(s) or drug metabolite(s)” with the phrase “A calibrator with its drug concentration at the cutoff.”
Section 26.167(e)(3)(iii) would be revised to replace the phrase “a drug(s) or drug metabolites” with the phrase “the drug or drug metabolite.”
Section 26.167(e)(3)(iv) would be revised to replace the phrase “At least one calibrator or control that is targeted” with the phrase “At least one control targeted.”
Section 26.167(f)(3) would be revised to make an editorial correction to the phrase “a statement by the laboratory's responsible person” by capitalizing the position title in that phrase to “Responsible Person.”
Section 26.168(h)(1) would be revised to remove the phrase “and for no more than 6 months” from this requirement.
Section 26.169(a) would be revised to correct the capitalization of the “c” and the “s” in the position title in the phrase “the laboratory's certifying scientist” to “Certifying Scientist.”
The HHS-certified laboratory annual statistical summary reporting requirements in § 26.169(h)(3) would be revised to add MDMA and MDA to the list of amphetamines test results that a laboratory must report as required by § 26.169(h)(3)(v). Additional conforming changes would be made to the names of the drugs and drug metabolites listed in § 26.169(h)(3) to include adding “(as THCA)” after “Marijuana metabolite” in § 26.169(h)(3)(i), adding “(as benzoylecgonine)” after “Cocaine metabolite” in § 26.169(h)(3)(ii), revising 6-AM to “6-acetylmorphine (6-AM)” in § 26.169(h)(3)(iii)(C), and revising “Phencyclidine” to “Phencyclidine (PCP)” in § 26.169(h)(3)(iv).
Section 26.183 would be revised to remove the phrase “at the licensee's or other entity's discretion” from § 26.183(c), (c)(1), and (d)(2)(ii).
Section 26.185(f)(3) would be redesignated as (f)(4), and a new paragraph (f)(3) would be added to state that if there is no legitimate technical or medical explanation for an invalid test result based on a pH result greater than or equal to 9.0 but less than or equal to 9.5, the MRO shall consider whether there is evidence of elapsed time, exposure of the specimen to high temperature, or both that could account for the pH value. If the MRO obtains objective and sufficient information regarding elapsed time, temperature conditions, or both to conclude that an acceptable explanation exists for the invalid test result due to pH, the MRO would direct the licensee or other entity to collect a second urine specimen from the donor as soon as reasonably practicable. This second specimen may not be collected from the donor under direct observation conditions.
Section 26.185(g)(2) would be revised to replace the phrase “If the licensee or other entity requires the HHS-certified laboratory to conduct the special analysis of dilute specimens permitted by § 26.163(a)(2), the results of the special analysis are positive,” with the phrase “If the results of the special analysis testing required by § 26.163(a)(2) are positive.”
Section 26.185(g)(2)(iii) would be revised to remove the phrase “clearly and unequivocally.”
Section 26.185(g)(3) would be removed.
Section 26.185(g)(4) and (g)(5) would be redesignated as § 26.185(g)(3) and (g)(4), respectively, and the cross-reference under § 26.163(a)(1) would be updated to reflect these changes.
Section 26.405(d) would be revised to add MDMA and MDA as substances for which licensees and other entities are required to test in each specimen.
Section 26.415(c) would be revised to eliminate the phrase “(65 FR 41944; August 9, 2001).”
Section 26.717(b)(3) would be revised to replace the phrase “(
Section 26.717(b)(4) would be revised to replace the phrase “(
The NRC is seeking advice and recommendations from stakeholders on this proposed rule. We are particularly interested in comments and supporting rationale from the public on the following:
Two proposed changes in this rule would eliminate redundant provisions in 10 CFR part 26 that also appear in the HHS Guidelines (
The proposed rule includes new requirements in § 26.163(a)(2) for the special analyses testing of urine specimens for drugs and drug metabolites. The first would require
Section 26.31(d)(1)(i)(D) permits a licensee or other entity to utilize lower cutoff levels and drug testing assays without forensic toxicologist review if the HHS Guidelines are revised to authorize use of the assay and testing cutoff levels. However, § 26.161(h) prohibits licensees and other entities from using more stringent cutoff levels for validity tests. The NRC is seeking comment on whether § 26.161(h) should be revised to provide a licensee or other entity with the option to conduct additional specimen validity tests and/or to utilize lower cutoff levels if the HHS Guidelines are revised in the future to include such testing.
If the proposed rule is finalized, the NRC anticipates providing a 60-day implementation period from the date that the final rule is published in the
The proposed rule retains the requirement for direct observation during the collection of a second sample when there are indications of a subversion attempt during the initial collection. The NRC is seeking comment on whether there are any effective alternatives to direct observation that will assist in preventing subversion of the drug testing process.
On January 23, 2017, HHS issued its latest revision of the Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Urine Specimens (82 FR 7920). Subpart C, “Urine Drug and Specimen Validity Tests,” of the 2017 HHS Guidelines was revised to include additional initial and confirmatory test analytes for certain opioids; specifically, hydrocodone, hydromorphone, oxycodone, and oxymorphone. The NRC is seeking comment on whether §§ 26.31(d)(1) and 26.405(d) should be revised to identify hydrocodone, hydromorphone, oxycodone, and oxymorphone test substances, and whether §§ 26.133 and 26.163(a)(1) and (b)(1) should be revised to require initial and confirmatory testing of these drugs at the cutoff levels recommended in the 2017 HHS Guidelines.
The 2008 HHS Guidelines adds methylenedioxyethylamphetamine (MDEA) as a confirmatory analyte to the drug testing panel in Section 3.4. However, when the HHS revised the mandatory guidelines in 2017, HHS removed MDEA from Section 3.4 stating that “[t]he Department has evaluated the comments and has removed MDEA from the Guidelines (
Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), the NRC certifies that this rule will not, if promulgated, have a significant economic impact on a substantial number of small entities. This proposed rule affects the licensing and operation of nuclear power plants and Category I fuel cycle facilities. The companies that own these facilities do not fall within the scope of the definition of “small entities” set forth in the Regulatory Flexibility Act or the size standards established by the NRC (§ 2.810).
The NRC estimates that none of the 67 entities affected by the rule would fall within the scope of the definition of “small entities” set forth in the Regulatory Flexibility Act or the size standards established by the NRC (§ 2.810). Therefore, the rule would not impact a substantial number of small entities.
The NRC has prepared a draft regulatory analysis on this proposed regulation. The analysis examines the costs and benefits of the alternatives considered by the NRC. The NRC requests public comment on the draft regulatory analysis. The regulatory analysis is available as indicated in the “Availability of Documents” section of this document. Comments on the draft analysis may be submitted to the NRC as indicated under the
The proposed rule would apply to all current nuclear power plant licensees (including holders of renewed licenses under 10 CFR part 54, “Requirements for Renewal of Operating Licenses for Nuclear Power Plants,” and combined licenses under 10 CFR part 52, “Licenses, Certifications, and Approvals for Nuclear Power Plants”) and holders of licenses authorizing the possession, use, or transport of formula quantities of SSNM under 10 CFR part 70, “Domestic Licensing of Special Nuclear Material.” The proposed rule would apply to holders of a certificate of compliance or an approved compliance plan under the provisions of 10 CFR part 76, “Certification of Gaseous Diffusion Plants,” if the holder engages in activities involving formula quantities of SSNM. Some or all of the proposed rule would apply to: (i) Current and future applicants for combined licenses under 10 CFR part 52 who have been issued a limited work authorization (LWA) under § 50.10(e), if the LWA authorizes the applicant to install the foundations, including the placement of concrete, for safety- and security-related structures, systems, and components (SSCs) under the LWA; (ii) combined license holders before the Commission has made the finding under § 52.103(g); (iii) power reactor construction permit applicants (under 10 CFR part 50, “Domestic Licensing of Production and Utilization Facilities”) who have been
The rule would constitute backfitting as defined under § 50.109(a)(1) for current holders of 10 CFR part 50 operating licenses and construction permits for power reactors and under § 70.76(a)(1) for applicable current 10 CFR part 70 licensees. The NRC has performed a backfit analysis consistent with NUREG/BR-0058, Revision 4, “Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission.” The backfit analysis can be found at appendix E of the regulatory analysis. The NRC has determined the backfitting is justified because: (1) There would be a substantial increase in the overall level of protection of the public health and safety or the common defense and security to be derived from the backfitting and (2) the costs of implementation and the annual costs would be justified in view of this increase.
Imposing the requirements of the proposed rule on current holders of combined licenses would represent an inconsistency with the issue finality provision applicable to combined licenses under § 52.98, “Finality of combined licenses; information requests.” Therefore, the NRC has addressed the criteria in § 52.98 that would allow imposition of the proposed rule on current holders of combined licenses, despite the issue finality accorded to the combined license holders. The NRC believes that the proposed rule may be imposed as a cost-justified substantial increase in the protection of the public health and safety or common defense and security. The bases for this determination are presented in the backfit analysis found in appendix F of the regulatory analysis.
Imposing the requirements of the proposed rule on current and future applicants for power reactor construction permits under 10 CFR part 50, part 70 licenses, or early site permits or combined licenses under 10 CFR part 52 would not constitute backfitting. Neither § 50.109, “Backfitting,” nor the issue finality provisions for early site permits or combined licenses under 10 CFR part 52 protect either a current or prospective applicant for a construction permit, part 70 license, early site permit, or combined license from changes in the NRC rules and regulations. The NRC has long adopted the position that § 50.109 does not protect current or prospective applicants from changes in NRC requirements or guidance because the policies underlying § 50.109 are largely inapplicable in the context of a current or future application. This position also applies to each of the issue finality provisions under 10 CFR part 52.
The provisions under 10 CFR part 26 also apply to applicants for construction permits, early site permits, or combined licenses who have been issued an LWA, if the LWA authorizes the applicant to install the foundations, including the placement of concrete, for safety- and security-related SSCs under the LWA. As of September 16, 2019, no LWAs have been issued to an applicant for a construction permit, early site permit, or combined license, so no such entity is protected by the backfitting and issue finality provisions from the changes proposed in this rulemaking.
Similarly, no entity holds a certificate of compliance or an approved compliance plan under the provisions of 10 CFR part 76, so no entity is protected by the backfitting provisions of § 76.76, “Backfitting,” from the changes proposed in this rulemaking.
The guidance in DG-5040 presents methods acceptable to the NRC for implementing portions of this proposed rule. The draft guide would apply to current holders of nuclear power plant licenses (including holders of renewed licenses under 10 CFR part 54 and combined licenses under 10 CFR part 52) and current holders of licenses authorizing the possession, use, or transport of formula quantities of SSNM under 10 CFR part 70. The DG would also apply to holders of a certificate of compliance or an approved compliance plan under the provisions of 10 CFR part 76 if the holder engages in activities involving formula quantities of SSNM.
The DG would also apply to the following current and future entities: (1) Applicants for combined licenses under 10 CFR part 52 who have been issued an LWA under § 50.10(e), if the LWA authorizes the applicant to install the foundations, including the placement of concrete, for safety- and security-related SSCs under the LWA; (2) combined license holders before the Commission has made the finding under § 52.103(g); (3) power reactor construction permit applicants (under 10 CFR part 50) who have been issued an LWA, if the LWA authorizes the applicant to install the foundations, including the placement of concrete, for safety- and security-related SSCs under the LWA; (4) power reactor construction permit holders; and (5) early site permit holders who have been issued an LWA, if the LWA authorizes the early site permit holder to install the foundations, including the placement of concrete, for safety- and security-related SSCs under the LWA, if these entities elect to implement an FFD program that meets the requirements of subparts A through H, N, and O of 10 CFR part 26.
Issuance of the DG in final form would not constitute backfitting under 10 CFR part 50, 70, or 76 and would not otherwise be inconsistent with the issue finality provisions under 10 CFR part 52. As discussed in the “Implementation” section of the DG, the NRC has no current intention to impose the DG, if finalized, on current holders of 10 CFR part 50 operating licenses or construction permits, 10 CFR part 52 combined licenses or early site permits, 10 CFR part 70 licenses, or 10 CFR part 76 certificates of compliance or approved compliance plans.
The DG, if finalized, could be applied to applicants for 10 CFR part 50 operating licenses or construction permits for power reactors, 10 CFR part 52 combined licenses or early site permits, licenses issued under 10 CFR part 70, or 10 CFR part 76 certificates of compliance or approved compliance plans. Such action would not constitute backfitting as defined under § 50.109, § 70.76, or § 76.76, or be otherwise inconsistent with the applicable issue finality provisions under 10 CFR part 52, inasmuch as such applicants are not within the scope of entities protected by § 50.109, § 70.76, § 76.76, or the relevant issue finality provisions under 10 CFR part 52, except in one circumstance. The exception to this principle is a combined license, early site permit, or construction permit applicant that has been issued an LWA, if the LWA authorizes the applicant to install the foundations, including the placement of concrete, for safety- and security-related SSCs under the LWA. However, that exception would provide backfitting and issue finality protection for the LWA holder only to the extent that it conducts activities under the LWA.
The NRC seeks to minimize any potential negative consequences resulting from the cumulative effects of regulation (CER). The CER describes the challenges that licensees, or other impacted entities such as State partners, may face while implementing new regulatory positions, programs, or requirements (
In an effort to better understand the potential CER implications incurred due to this proposed rule, the NRC is requesting comment on the following questions. Responding to these questions is voluntary, and the NRC will respond to any comments received in the final rule.
1. In light of any current or projected CER challenges, does the proposed rule's effective date provide sufficient time to implement the new proposed requirements, including changes to programs, procedures, and the facility?
2. If current or projected CER challenges exist, what should be done to address this situation? For example, if more time is required for implementation of the new requirements, what period of time is sufficient?
3. Do other regulatory actions (from the NRC or other agencies) influence the implementation of the proposed rule's requirements?
4. Are there unintended consequences? Does the proposed rule create conditions that would be contrary to the proposed rule's purpose and objectives? If so, what are the unintended consequences, and how should they be addressed?
5. Please comment on the NRC's cost and benefit estimates in the regulatory analysis that supports the proposed rule.
The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31885). The NRC requests comment on this document with respect to the clarity and effectiveness of the language used.
The NRC has determined that this proposed rule is the type of action described under § 51.22(c)(1). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this proposed rule.
This proposed rule contains new or amended collections of information subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This proposed rule has been submitted to the Office of Management and Budget (OMB) for review and approval of the information collection(s).
The NRC is seeking public comment on the potential impact of the information collection(s) contained in this proposed rule and on the following issues:
1. Is the proposed information collection necessary for the proper performance of the functions of the NRC, including whether the information will have practical utility?
2. Is the estimate of burden of the proposed information collection accurate?
3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?
4. How can the burden of the proposed information collection on respondents be minimized, including the use of automated collection techniques or other forms of information technology?
A copy of the OMB clearance package and proposed rule is available in ADAMS under Accession No. ML16123A003 or may be viewed free of
You may submit comments on any aspect of these proposed information collection(s), including suggestions for reducing the burden and on the above issues, by the following methods:
•
•
Submit comments by October 16, 2019. Comments received after this date will be considered if it is practical to do so, but the NRC staff is able to ensure consideration only for comments received on or before this date.
The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information unless the document requesting or requiring the collection displays a currently valid OMB control number.
Under the “Policy Statement on Adequacy and Compatibility of Agreement State Programs” approved by the Commission on June 30, 1997, and published in the
The National Technology Transfer and Advancement Act of 1995, Public Law 104-113, requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this proposed rule, the NRC is proposing to update and enhance the consistency of 10 CFR part 26 with the 2008 HHS Guidelines; improve the effectiveness and efficiency of FFD programs with regard to drug testing; and improve clarity in the organization and language of the rule. This action would not constitute the establishment of a voluntary consensus standard that contains generally applicable requirements.
The NRC is issuing for comment new draft regulatory guidance, Draft Regulatory Guide DG-5040, “Urine Specimen Collection and Test Result Review under 10 CFR Part 26, Fitness for Duty Programs,” to support the implementation of the proposed requirements in this rulemaking. You may access information and comment submissions related to the DG by searching on
The guidance describes methods that the NRC would consider acceptable for complying with some of the proposed changes in this notice. For example, guidance would be provided concerning monitoring of a donor during the 3-hour hydration period, use of reflective mirrors for directly observed collections, use of a same-gender observer other than the collector during a directly observed collection, and MRO review of invalid test results due to high pH.
The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.
Administrative practice and procedure, Alcohol abuse, Alcohol testing, Appeals, Chemical testing, Drug abuse, Drug testing, Employee assistance programs, Fitness for duty, Management actions, Nuclear power plants and reactors, Privacy, Protection of information, Radiation protection, Reporting and recordkeeping requirements.
For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553 the NRC is proposing to adopt the following amendments to 10 CFR part 26:
Atomic Energy Act of 1954, secs. 53, 103, 104, 107, 161, 223, 234, 1701 (42 U.S.C. 2073, 2133, 2134, 2137, 2201, 2273, 2282, 2297f); Energy Reorganization Act of 1974, secs. 201, 202 (42 U.S.C. 5841, 5842); 44 U.S.C. 3504 note.
The additions and revisions read as follows:
(g) * * *
(6) All persons monitoring a donor during the hydration process described in § 26.109(b).
(j) * * *
(3) Urine specimens are tested for validity and the presence of drugs and drug metabolites at a Department of Health and Human Services (HHS)-certified laboratory, as defined in § 26.5;
The additions and revisions read as follows:
The revisions read as follows:
(d) * * *
(1)
(ii) * * * Test results that fall below the established cutoff levels may not be considered when determining appropriate action under subpart D of this part, except if special analyses of the specimen is performed under § 26.163(a)(2) by the HHS-certified laboratory.
(d) In order to promote the security of specimens, avoid distraction of the collector, and ensure against any confusion in the identification of specimens, a collector shall conduct only one collection procedure at any given time, except as described in § 26.109(b)(1). The urine collection procedure is complete when the urine specimen container has been sealed with tamper-evident tape, the seal has been dated and initialed, and the Federal CCF has been completed or when a refusal to test has been determined under § 26.107(d).
(b)(1) The collector shall pay attention to the donor during the entire collection process, except as provided in § 26.109(b)(1), to observe any conduct that indicates an attempt to subvert the testing process (
(2) If a hydration monitor is used to observe a donor during the § 26.109(b)(1) hydration process, this individual shall immediately inform the collector of any donor conduct that may indicate an attempt to subvert the testing process (
(d) If a refusal to test is determined at any point during the specimen collection process, the collector shall do the following:
(1) Inform the donor that a refusal to test has been determined;
(2) Terminate the collection process;
(3) Document a description of the refusal to test on the Federal CCF;
(4) Discard any urine specimen(s) provided by the donor, unless the specimen was collected for a post-event test under § 26.31(c)(3); and
(5) Immediately inform the FFD program manager.
(b) * * *
(1) The collector shall encourage the donor to drink a reasonable amount of liquid (normally, 8 ounces of water every 30 minutes, but not to exceed a maximum of 40 ounces over 3 hours) until the donor provides a specimen of at least 30 mL. Alternatively, as specified in the licensee's or other entity's FFD program procedures, the collector may assign responsibility for monitoring a donor during the hydration process to another collector who meets the requirements in § 26.85(a) or to a hydration monitor who meets the requirements in § 26.4(g)(6). If another collector or hydration monitor is used, the collector:
(i) Shall explain the hydration process and acceptable donor behavior to the hydration monitor;
(ii) Shall record the name of the other collector or hydration monitor on the Federal CCF and then provide the Federal CCF to that individual for the duration of the hydration process; and
(iii) May perform other collections while the donor is in the hydration process;
(2) The collector shall provide the donor with a separate collection container for each successive specimen. * * *
The revisions read as follows:
(a) Immediately after the donor provides the urine specimen to the collector, including specimens of less than 30 mL but equal to or greater than 15 mL, the collector shall measure the temperature of the specimen. The temperature measuring device used must accurately reflect the temperature of the specimen and not contaminate the specimen. The time from urination to temperature measurement may not exceed 4 minutes. If the temperature of a urine specimen is outside the range of 90 °F to 100 °F (32 °C to 38 °C), that is a reason to believe the donor may have altered (
(c) * * * In addition, the collector shall inform the donor that he or she may volunteer to submit a second specimen under direct observation to counter the reason to believe the donor may have altered (
(e) As much of the suspect specimen as possible must be preserved, except under the conditions described in § 26.107(d)(4).
The additions and revisions read as follows:
(a) Procedures for collecting urine specimens must provide for the donor's privacy unless directed by this subpart or the MRO or FFD program manager determines that a directly observed collection is warranted. The following circumstances constitute the exclusive grounds for performing a directly observed collection:
(3) The collector, or the hydration monitor if one is used as permitted in § 26.109(b)(1), observes conduct by the donor indicating an attempt to subvert the testing process;
(4) A directly observed collection is required under § 26.69; or
(5) The donor requests a retest and either Bottle B or the single specimen is not available due to circumstances outside of the donor's control, as described in § 26.165(f)(2).
(e) The collector shall ensure that the observer is the same gender as the donor. A person of the opposite gender may not act as the observer under any conditions. The observer may be a different person from the collector and need not be a qualified collector. If the observer is not a qualified collector, the collector shall, in the presence of the donor, instruct the observer on the collection procedures in paragraph (f) of this section before proceeding with the directly observed collection.
(f) The individual who observes the collection shall follow these procedures:
(1) The observer shall instruct the donor to adjust his or her clothing to ensure that the area of the donor's body between the waist and knees is exposed;
(2) The observer shall watch the donor urinate into the collection container. Specifically, the observer shall watch the urine go from the donor's body into the collection container. A reflective mirror may be used to assist in observing the provision of the specimen only if the physical configuration of the room, stall, or private area is not sufficient to meet this direct observation requirement; the use of a video camera to assist in the observation process is not permitted;
(3) If the observer is not the collector, the observer may not touch or handle the collection container but shall maintain visual contact with the specimen until the donor hands the collection container to the collector; and
(g) If a donor declines to allow a directly observed collection that is required or permitted under this section, the donor's refusal constitutes an act to subvert the testing process, and the collector shall follow the procedures in § 26.107(d).
The revisions read as follows:
(a) Once the collector is presented with the specimen from the donor, both the donor and the collector shall keep the donor's urine specimen(s) in view at all times before the specimen(s) are sealed and labeled. If any specimen or aliquot is transferred to another container, the collector shall ask the donor to observe the transfer and sealing of the container with a tamper-evident seal.
(f) The specimens and Federal CCFs must be packaged for transfer to the HHS-certified laboratory or to the licensee testing facility. * * *
(b) * * *
(1) * * *
(ii) If there is reason to believe that the integrity or identity of a specimen is in question (as a result of tampering or discrepancies between the information on the specimen bottle and on the accompanying Federal CCFs that cannot be resolved), the licensee testing facility shall reject the specimen for testing. The licensee or other entity shall ensure that another collection occurs as soon as reasonably practical, except if a split specimen collection was performed, either the Bottle A or Bottle B seal remains intact, and the intact specimen contains at least 15 mL of urine. In this instance, the licensee testing facility shall forward the intact specimen for testing to the HHS-certified laboratory and may not conduct any testing at the licensee testing facility.
(2) The following are exclusive grounds requiring the MRO to cancel the testing of a donor's urine specimen and report a cancelled test result to the licensee or other entity:
Subject to the provisions of § 26.31(d)(3)(iii), licensees and other entities may specify more stringent cutoff levels for drugs and drug metabolites than those in the table below and, in such cases, may report initial test results for only the more stringent cutoff levels. Otherwise, the following cutoff levels must be used for initial testing of urine specimens to determine whether they are negative or positive for the indicated drugs and drug metabolites:
(d) * * *
(5) Each analytical run performed to conduct initial validity testing shall include at least one quality control sample that appears to be a normal specimen to the licensee testing facility technicians.
(e) * * *
(6) A minimum of 10 percent of the total specimens in each analytical run of specimens to be initially tested for drugs and drug metabolites by the licensee testing facility must be quality control samples (
(i) At least one control certified by an HHS-certified laboratory to contain no drug or drug metabolite;
(ii) At least one positive control with the drug or drug metabolite targeted at 25 percent above the cutoff;
(iii) At least one positive control with the drug or drug metabolite targeted at 75 percent of the cutoff;
(v) At least one quality control sample that appears to be a normal specimen to the licensee testing facility technicians.
(a) Licensees and other entities who are subject to this part shall use only HHS-certified laboratories as defined in § 26.5.
(g) If licensees or other entities use a form other than the current Federal CCF, licensees and other entities shall provide a memorandum to the laboratory explaining why a non-Federal CCF was used, but must ensure, at a minimum, that the form used contains all the required information on the Federal CCF.
The revisions read as follows:
(a) HHS-certified laboratories shall develop, implement, and maintain procedures specific to this part that document the accession, receipt, shipment, and testing of specimens.
(b) [Reserved]
(b) * * *
(1) * * *
(ii) If the licensee or other entity has reason to question the integrity and identity of the specimens, the laboratory shall reject the specimens for testing. The licensee or other entity shall ensure that another collection occurs as soon as reasonably practical, except if a split specimen collection was performed, either the Bottle A or Bottle B seal remains intact, and the intact specimen contains at least 15 mL of urine. In this instance, if the licensee testing facility has retained the specimen in Bottle B, the licensee testing facility shall forward the intact specimen for testing to the HHS-certified laboratory and may not conduct any testing at the licensee testing facility.
(2) The following are exclusive grounds requiring the MRO to cancel the testing of a donor's urine specimen and report a cancelled test to the licensee or other entity:
(c) * * * Laboratory personnel shall use aliquots and laboratory internal chain of custody forms when conducting initial and confirmatory tests.* * *
(d) The laboratory's internal chain of custody form must allow for identification of the donor and documentation of the testing process and transfers of custody of the specimen.
(e) Each time a specimen is handled or transferred within the laboratory, laboratory personnel shall document the date and purpose on the chain of custody form and every individual in the chain shall be identified. Authorized technicians are responsible for each urine specimen or aliquot in their
The revisions read as follows:
(c) * * *
(5) The presence of glutaraldehyde is verified using either an aldehyde test (aldehyde present) or the characteristic immunoassay response on one or more drug immunoassay tests for the initial test on the first aliquot and a different confirmatory test (
(6) The presence of pyridine (pyridinium chlorochromate) is verified using either a general oxidant colorimetric test (with an equal to or greater than 200 mcg/mL nitrite-equivalent cutoff or an equal to or greater than 50 mcg/mL chromium (VI)- equivalent cutoff) or a chromium (VI) colorimetric test (chromium (VI) concentration equal to or greater than 50 mcg/mL) for the initial test on the first aliquot and a different confirmatory test (
The revisions read as follows:
(a)
(2) HHS-certified laboratories shall conduct special analyses of specimens as follows:
(i) If initial validity testing indicates that a specimen is dilute, or if a specimen is collected under direct observation for any of the conditions specified in § 26.115(a)(1) through (a)(3) or (a)(5), the laboratory shall compare the immunoassay responses of the specimen to the cutoff calibrator in each drug class tested;
(ii) If any immunoassay response is equal to or greater than 40 percent of the cutoff calibrator, the laboratory shall conduct confirmatory drug testing of the specimen to the LOQ for those drugs and/or drug metabolites; and
(b)
(b) * * *
(2) * * * The MRO shall document in his or her records when (
(3) No entity, other than the MRO as permitted in § 26.185(l), may order the retesting of an aliquot of a single specimen or the testing of the Bottle B split specimen.
(f) * * *
(1) * * * If the results of testing Bottle B or retesting the aliquot of a single specimen are negative, the MRO shall report a cancelled test result to the licensee or other entity, and the licensee and other entity—
(2) If a donor requests that Bottle B be tested or that an aliquot of a single specimen be retested, and either Bottle B or the single specimen are not available due to circumstances outside of the donor's control (including, but not limited to, circumstances in which there is an insufficient quantity of the single specimen or the specimen in Bottle B to permit retesting, either Bottle B or the original single specimen is lost in transit to the second HHS-certified laboratory, or Bottle B has been lost at the HHS-certified laboratory or licensee testing facility), the MRO shall cancel the test, report a cancelled test result to the licensee or other entity for the donor's specimen, and inform the licensee or other entity that another collection is required under direct observation as soon as reasonably practical. The donor shall receive no notice of the collection requirement before he or she is instructed to proceed to the collection site. The licensee or
The revisions read as follows:
(d) * * *
(3) Quality control samples for each analytical run of specimens for initial testing must include—
(i) At least one control certified to contain no drug or drug metabolite;
(ii) At least one positive control with the drug or drug metabolite targeted at 25 percent above the cutoff;
(iii) At least one positive control with the drug or drug metabolite targeted at 75 percent of the cutoff;
(4) A minimum of 10 percent of the total specimens in each analytical run must be quality control samples (
(e) * * *
(2) A minimum of 10 percent of the total specimens in each analytical run must be quality control samples (
(3) Each analytical run of specimens that are subjected to confirmatory testing must include—
(i) At least one control certified to contain no drug or drug metabolite;
(ii) A calibrator with its drug concentration at the cutoff;
(iii) At least one positive control with the drug or drug metabolite targeted at 25 percent above the cutoff; and
(iv) At least one control targeted at or below 40 percent of the cutoff.
(h) * * *
(1) Ensure that all blind performance test sample lots are placed in service by the supplier only after confirmation by an HHS-certified laboratory;
The additions and revisions read as follows:
(h) * * *
(3) Number of specimens reported as positive on confirmatory tests by drug or drug metabolite for which testing is conducted, including, but not limited to—
(i) Marijuana metabolite (as THCA);
(ii) Cocaine metabolite (as benzoylecgonine);
(C) 6-acetylmorphine (6-AM);
(iv) Phencyclidine (PCP);
(v) Amphetamines (total);
(A) Amphetamine;
(C) Methylenedioxymethamphetamine (MDMA); and
(D) Methylenedioxyamphetamine (MDA);
(c)
(1) In carrying out these responsibilities, the MRO shall examine alternate medical explanations for any positive, adulterated, substituted, invalid, or dilute test result. This action may include, but is not limited to, conducting a medical interview with the donor, reviewing the donor's medical history, or reviewing any other relevant biomedical factors. The MRO shall review all medical records that the donor may make available when a positive, adulterated, substituted, invalid, or dilute test result could have resulted from responsible use of legally prescribed medication, a documented condition or disease state, or the demonstrated physiology of the donor.
(d) * * *
(2) * * *
(ii) The staff reviews of positive, adulterated, substituted, invalid, and dilute test results must be limited to reviewing the Federal CCF to determine whether it contains any errors that may require corrective action and to ensure that it is consistent with the information on the MRO's copy. The staff may resolve errors in Federal CCFs that require corrective action(s), but shall forward the Federal CCFs to the MRO for review and approval of the resolution.
The addition and revisions read as follows:
(f) * * *
(3) If the MRO and the laboratory agree that further testing would not be useful and there is no legitimate technical or medical explanation, and the invalid result is based on pH in the range of 9.0 to 9.5, the MRO shall consider whether there is evidence of elapsed time, exposure of the specimen to high temperature, or both that could account for the pH value. If an acceptable explanation exists for the invalid test result due to pH, based on objective and sufficient information, that elapsed time, high temperature, or both caused the high pH and donor action did not result in the invalid pH result, the MRO shall report a cancelled test result to the licensee or other entity, cancel the test result, and direct the licensee or other entity to collect a second urine specimen from the donor as soon as reasonably practicable. The second specimen collected may not be collected under direct observation.
(g) * * *
(2) If the results of the special analysis testing required by § 26.163(a)(2) are positive, the MRO determines that there is no legitimate medical explanation for the presence of the drug(s) or drug metabolite(s) in the specimen, and a clinical examination, if required under paragraph (g)(3) of this section, has been conducted under paragraph (j) of this section, the MRO shall determine whether the positive and dilute specimen is a refusal to test. If the MRO does not have sufficient reason to believe that the positive and dilute specimen is a subversion attempt, he or she shall determine that the drug test results are positive and that the donor has violated the FFD policy. When determining whether the donor has diluted the specimen in a subversion attempt, the MRO shall also consider the following circumstances, if applicable:
(iii) The collector observed conduct indicating an attempt to dilute the specimen.
(d) At a minimum, licensees and other entities shall test specimens for marijuana metabolite, cocaine metabolite, opiates (codeine, morphine, and 6-acetylmorphine), amphetamines (amphetamine, methamphetamine, methylenedioxymethamphetamine, and methylenedioxyamphetamine), phencyclidine, adulterants, and alcohol at the cutoff levels specified in this part, or comparable cutoff levels if specimens other than urine are collected for drug testing. Urine specimens collected for drug testing must be subject to validity testing.
(b) * * *
(3) Populations tested (
(4) Number of tests administered and results of those tests sorted by population tested (
For the Nuclear Regulatory Commission.